[10-Q] Allurion Technologies, Inc. Quarterly Earnings Report
Allurion Technologies reported operational and financial updates alongside a restatement and remediation efforts for internal control weaknesses. The company is addressing a restatement of prior financial statements and disclosed material weaknesses in internal control over financial reporting while describing steps taken to remediate those weaknesses, including hiring experienced accounting staff, implementing a new ERP system, and engaging a national accounting firm. Management announced a strategic restructuring expected to reduce the workforce by about 70 employees (~65% of staff) with estimated severance-related charges of approximately $1.5 million. Financing activity included multiple private placements and offerings that raised net proceeds of $2.5 million (RTW private placement), $5.8 million (January 2025 offering), and $3.9 million (February 2025 offering), plus a Leavitt placement of $1.3 million. The company described amended revenue interest financing that increases payments from 6.0% up to 10.0% of annual net sales after 2027 and various conversion features tied to PIPE and RTW convertible notes. The filing discloses a pending litigation claim seeking approximately $2.5 million and details product, regulatory, and commercialization initiatives including a GLP-1 program, distribution transitions, and a planned multi-center study in Europe.
Allurion Technologies ha comunicato aggiornamenti operativi e finanziari insieme a una riformulazione dei bilanci e a interventi correttivi per carenze nei controlli interni. L'azienda sta provvedendo alla riformulazione di bilanci precedenti e ha resa nota l'esistenza di carenze rilevanti nel controllo interno sulla rendicontazione finanziaria, descrivendo le misure adottate per sanare tali debolezze, tra cui l'assunzione di personale contabile esperto, l'implementazione di un nuovo sistema ERP e l'ingaggio di una società contabile nazionale. La direzione ha annunciato una ristrutturazione strategica che dovrebbe comportare la riduzione di circa 70 dipendenti (~65% del personale) con oneri stimati per le indennità di fine rapporto di circa $1,5 milioni. Le attività di finanziamento hanno incluso più collocamenti e offerte private che hanno raccolto proventi netti di $2,5 milioni (collocamento privato RTW), $5,8 milioni (offerta di gennaio 2025) e $3,9 milioni (offerta di febbraio 2025), oltre a un collocamento Leavitt di $1,3 milioni. L'azienda ha descritto un finanziamento con interesse sulle entrate modificato che aumenta i pagamenti dal 6,0% fino al 10,0% delle vendite nette annuali dopo il 2027 e varie clausole di conversione legate a note convertibili PIPE e RTW. Il deposito rivela una controversia legale pendente che richiede circa $2,5 milioni e dettaglia iniziative sui prodotti, regolatorie e di commercializzazione, incluso un programma GLP-1, transizioni distributive e uno studio multicentrico pianificato in Europa.
Allurion Technologies informó actualizaciones operativas y financieras junto con una rectificación y esfuerzos de corrección por debilidades en el control interno. La compañía está abordando una rectificación de estados financieros previos y divulgó debilidades materiales en el control interno sobre la información financiera, describiendo las medidas tomadas para remediarlas, incluyendo la contratación de personal contable experimentado, la implementación de un nuevo sistema ERP y la contratación de una firma contable nacional. La dirección anunció una reestructuración estratégica que se espera reduzca la plantilla en aproximadamente 70 empleados (~65% del personal) con cargos estimados por indemnizaciones de aproximadamente $1.5 millones. La actividad de financiación incluyó varias colocaciones privadas y ofertas que recaudaron ingresos netos de $2.5 millones (colocación privada RTW), $5.8 millones (oferta de enero de 2025) y $3.9 millones (oferta de febrero de 2025), además de una colocación Leavitt de $1.3 millones. La compañía describió un financiamiento de participación en ingresos enmendado que aumenta los pagos del 6.0% hasta el 10.0% de las ventas netas anuales después de 2027 y varias características de conversión vinculadas a notas convertibles PIPE y RTW. La presentación revela una demanda pendiente que busca aproximadamente $2.5 millones y detalla iniciativas de producto, regulatorias y de comercialización, incluyendo un programa GLP-1, transiciones de distribución y un estudio multicéntrico planificado en Europa.
Allurion Technologies는 내부 통제 약점에 대한 정정 및 개선 조치와 함께 운영 및 재무 업데이트를 보고했습니다. 회사는 과거 재무제표의 정정 처리를 진행 중이며 재무보고에 대한 내부 통제의 중대한 약점을 공시하고, 이러한 약점을 시정하기 위해 숙련된 회계 인력 채용, 새로운 ERP 시스템 도입, 국내 회계법인 참여 등 조치를 설명했습니다. 경영진은 약 70명(직원 약 65%)의 감원을 예상하는 전략적 구조조정을 발표했으며, 퇴직 관련 비용은 약 $1.5백만으로 추정됩니다. 자금 조달 활동에는 여러 사모 배정 및 공모가 포함되어 순수익으로 $2.5백만(RTW 사모), $5.8백만(2025년 1월 공모), $3.9백만(2025년 2월 공모)을 조달했으며, 여기에 $1.3백만의 Leavitt 배정도 포함됩니다. 회사는 수정된 수익 참여형 자금조달을 설명했으며 이는 2027년 이후 연간 순매출의 6.0%에서 10.0%까지 지급을 증가시키고 PIPE 및 RTW 전환사채와 연계된 다양한 전환 조항을 포함합니다. 제출서류는 약 $2.5백만을 청구하는 소송이 진행 중임을 공개하고, GLP-1 프로그램, 유통 전환 및 유럽에서 계획된 다기관 연구 등 제품·규제·상용화 이니셔티브를 상세히 설명합니다.
Allurion Technologies a publié des mises à jour opérationnelles et financières ainsi qu'une révision des comptes et des mesures correctives pour des faiblesses du contrôle interne. La société procède à la révision d'états financiers antérieurs et a dévoilé des faiblesses importantes du contrôle interne sur l'information financière, en décrivant les actions prises pour y remédier, notamment le recrutement de personnel comptable expérimenté, la mise en place d'un nouveau système ERP et le recours à un cabinet comptable national. La direction a annoncé une restructuration stratégique qui devrait réduire les effectifs d'environ 70 employés (~65% du personnel) avec des charges estimées liées aux indemnités de licenciement d'environ 1,5 million $. Les opérations de financement comprenaient plusieurs placements privés et offres ayant permis de dégager des produits nets de 2,5 millions $ (placement privé RTW), 5,8 millions $ (offre de janvier 2025) et 3,9 millions $ (offre de février 2025), plus un placement Leavitt de 1,3 million $. La société a décrit un financement adossé aux revenus amendé qui augmente les paiements de 6,0% jusqu'à 10,0% des ventes nettes annuelles après 2027 et diverses caractéristiques de conversion liées aux billets convertibles PIPE et RTW. Le dépôt divulgue un litige en cours réclamant environ 2,5 millions $ et détaille des initiatives produit, réglementaires et de commercialisation, y compris un programme GLP-1, des transitions de distribution et une étude multicentrique prévue en Europe.
Allurion Technologies berichtete über operative und finanzielle Aktualisierungen sowie über eine Berichtigung und Abhilfemaßnahmen wegen Schwachstellen in der internen Kontrolle. Das Unternehmen geht eine Berichtigung früherer Jahresabschlüsse an und offenbart wesentliche Schwächen in der internen Kontrolle über die Finanzberichterstattung und beschreibt die ergriffenen Maßnahmen zur Behebung dieser Schwächen, darunter die Einstellung erfahrener Buchhaltungskräfte, die Implementierung eines neuen ERP-Systems und die Beauftragung einer nationalen Wirtschaftsprüfungsgesellschaft. Das Management kündigte eine strategische Umstrukturierung an, die voraussichtlich etwa 70 Mitarbeiter (~65% der Belegschaft) reduzieren wird, mit geschätzten Abfindungskosten von rund $1,5 Millionen. Zu den Finanzierungsaktivitäten gehörten mehrere Privatplatzierungen und Angebote, die Nettoerlöse von $2,5 Millionen (RTW-Privatplatzierung), $5,8 Millionen (Angebot Januar 2025) und $3,9 Millionen (Angebot Februar 2025) sowie eine Leavitt-Platzierung von $1,3 Millionen einbrachten. Das Unternehmen beschrieb eine geänderte umsatzabhängige Finanzierung, die Zahlungen von 6,0% auf bis zu 10,0% der jährlichen Nettoumsätze nach 2027 erhöht, sowie verschiedene Wandlungsmerkmale in Bezug auf PIPE- und RTW-Wandelschuldverschreibungen. Die Einreichung offenbart eine anhängige Klage mit Forderungen von etwa $2,5 Millionen und führt Produkt-, regulatorische und Kommerzialisierungsinitiativen aus, darunter ein GLP-1-Programm, Vertriebsübergänge und eine geplante multizentrische Studie in Europa.
- Completed multiple financings that provided net proceeds including $5.8M (January 2025) and $3.9M (February 2025), plus $2.5M RTW placement
- Active commercialization initiatives including a compounded GLP-1 program, a planned multi-center European study, and a term sheet for ex-US distribution and joint R&D
- Product ecosystem and digital platform features: Allurion Connected Scale, mobile app in 15 languages, and Allurion Insights/AI-powered clinic dashboard to support remote patient monitoring
- Remediation actions initiated for internal control weaknesses: hiring accounting staff, new ERP implementation, and engagement of a national accounting firm
- Restatement of prior financial statements and disclosure of material weaknesses in internal control over financial reporting
- Substantial workforce reduction (~70 employees, ~65% of workforce) with estimated severance of $1.5M, risking near-term operational capacity
- Increased recurring payment obligations under Revenue Interest Financing (rising from 6.0% up to 10.0% of annual net sales after 2027) and complex conversion features that may dilute equity
- Pending litigation claim (Vanderbilt) seeking approximately $2.5M
- Significant governance and accounting complexity from multiple recapitalizations, warrant repricings, derivative liabilities (PIPE Conversion Option), and ongoing FVO accounting for modified notes
Insights
TL;DR: Restatement and material weaknesses combined with heavy workforce reduction and recurring financing terms materially raise execution and liquidity risk.
The restatement of previously issued financial statements and disclosure of material weaknesses are significant governance and reporting failures that typically increase audit scrutiny and can delay financing or strategic transactions. The announced reduction in force—approximately 65% of employees—with an estimated $1.5 million severance charge is a material operational change that may reduce near-term cash burn but could impair sales and R&D execution. Multiple recent financings generated net proceeds aggregating roughly $13.5 million across transactions disclosed, but the company also increased recurring obligations under the Revenue Interest Financing to as much as 10% of annual net sales after 2027 and retains complex conversion and derivative features tied to PIPE and RTW instruments that can dilute existing shareholders or shift liabilities to equity unpredictably.
TL;DR: Material weaknesses and a restatement signal deficiencies in controls; remediation steps are appropriate but require time and verification.
The company has outlined concrete remediation efforts—hiring experienced accounting personnel, implementing a new ERP, and engaging external advisory resources—which are standard and necessary responses. However, until these controls operate effectively over time and are tested, investors and regulators will view reporting reliability as impaired. The complex capital structure changes, warrant repricings, and derivative accounting (PIPE Conversion Option under ASC 815) increase governance complexity and demand enhanced disclosure and oversight.
Allurion Technologies ha comunicato aggiornamenti operativi e finanziari insieme a una riformulazione dei bilanci e a interventi correttivi per carenze nei controlli interni. L'azienda sta provvedendo alla riformulazione di bilanci precedenti e ha resa nota l'esistenza di carenze rilevanti nel controllo interno sulla rendicontazione finanziaria, descrivendo le misure adottate per sanare tali debolezze, tra cui l'assunzione di personale contabile esperto, l'implementazione di un nuovo sistema ERP e l'ingaggio di una società contabile nazionale. La direzione ha annunciato una ristrutturazione strategica che dovrebbe comportare la riduzione di circa 70 dipendenti (~65% del personale) con oneri stimati per le indennità di fine rapporto di circa $1,5 milioni. Le attività di finanziamento hanno incluso più collocamenti e offerte private che hanno raccolto proventi netti di $2,5 milioni (collocamento privato RTW), $5,8 milioni (offerta di gennaio 2025) e $3,9 milioni (offerta di febbraio 2025), oltre a un collocamento Leavitt di $1,3 milioni. L'azienda ha descritto un finanziamento con interesse sulle entrate modificato che aumenta i pagamenti dal 6,0% fino al 10,0% delle vendite nette annuali dopo il 2027 e varie clausole di conversione legate a note convertibili PIPE e RTW. Il deposito rivela una controversia legale pendente che richiede circa $2,5 milioni e dettaglia iniziative sui prodotti, regolatorie e di commercializzazione, incluso un programma GLP-1, transizioni distributive e uno studio multicentrico pianificato in Europa.
Allurion Technologies informó actualizaciones operativas y financieras junto con una rectificación y esfuerzos de corrección por debilidades en el control interno. La compañía está abordando una rectificación de estados financieros previos y divulgó debilidades materiales en el control interno sobre la información financiera, describiendo las medidas tomadas para remediarlas, incluyendo la contratación de personal contable experimentado, la implementación de un nuevo sistema ERP y la contratación de una firma contable nacional. La dirección anunció una reestructuración estratégica que se espera reduzca la plantilla en aproximadamente 70 empleados (~65% del personal) con cargos estimados por indemnizaciones de aproximadamente $1.5 millones. La actividad de financiación incluyó varias colocaciones privadas y ofertas que recaudaron ingresos netos de $2.5 millones (colocación privada RTW), $5.8 millones (oferta de enero de 2025) y $3.9 millones (oferta de febrero de 2025), además de una colocación Leavitt de $1.3 millones. La compañía describió un financiamiento de participación en ingresos enmendado que aumenta los pagos del 6.0% hasta el 10.0% de las ventas netas anuales después de 2027 y varias características de conversión vinculadas a notas convertibles PIPE y RTW. La presentación revela una demanda pendiente que busca aproximadamente $2.5 millones y detalla iniciativas de producto, regulatorias y de comercialización, incluyendo un programa GLP-1, transiciones de distribución y un estudio multicéntrico planificado en Europa.
Allurion Technologies는 내부 통제 약점에 대한 정정 및 개선 조치와 함께 운영 및 재무 업데이트를 보고했습니다. 회사는 과거 재무제표의 정정 처리를 진행 중이며 재무보고에 대한 내부 통제의 중대한 약점을 공시하고, 이러한 약점을 시정하기 위해 숙련된 회계 인력 채용, 새로운 ERP 시스템 도입, 국내 회계법인 참여 등 조치를 설명했습니다. 경영진은 약 70명(직원 약 65%)의 감원을 예상하는 전략적 구조조정을 발표했으며, 퇴직 관련 비용은 약 $1.5백만으로 추정됩니다. 자금 조달 활동에는 여러 사모 배정 및 공모가 포함되어 순수익으로 $2.5백만(RTW 사모), $5.8백만(2025년 1월 공모), $3.9백만(2025년 2월 공모)을 조달했으며, 여기에 $1.3백만의 Leavitt 배정도 포함됩니다. 회사는 수정된 수익 참여형 자금조달을 설명했으며 이는 2027년 이후 연간 순매출의 6.0%에서 10.0%까지 지급을 증가시키고 PIPE 및 RTW 전환사채와 연계된 다양한 전환 조항을 포함합니다. 제출서류는 약 $2.5백만을 청구하는 소송이 진행 중임을 공개하고, GLP-1 프로그램, 유통 전환 및 유럽에서 계획된 다기관 연구 등 제품·규제·상용화 이니셔티브를 상세히 설명합니다.
Allurion Technologies a publié des mises à jour opérationnelles et financières ainsi qu'une révision des comptes et des mesures correctives pour des faiblesses du contrôle interne. La société procède à la révision d'états financiers antérieurs et a dévoilé des faiblesses importantes du contrôle interne sur l'information financière, en décrivant les actions prises pour y remédier, notamment le recrutement de personnel comptable expérimenté, la mise en place d'un nouveau système ERP et le recours à un cabinet comptable national. La direction a annoncé une restructuration stratégique qui devrait réduire les effectifs d'environ 70 employés (~65% du personnel) avec des charges estimées liées aux indemnités de licenciement d'environ 1,5 million $. Les opérations de financement comprenaient plusieurs placements privés et offres ayant permis de dégager des produits nets de 2,5 millions $ (placement privé RTW), 5,8 millions $ (offre de janvier 2025) et 3,9 millions $ (offre de février 2025), plus un placement Leavitt de 1,3 million $. La société a décrit un financement adossé aux revenus amendé qui augmente les paiements de 6,0% jusqu'à 10,0% des ventes nettes annuelles après 2027 et diverses caractéristiques de conversion liées aux billets convertibles PIPE et RTW. Le dépôt divulgue un litige en cours réclamant environ 2,5 millions $ et détaille des initiatives produit, réglementaires et de commercialisation, y compris un programme GLP-1, des transitions de distribution et une étude multicentrique prévue en Europe.
Allurion Technologies berichtete über operative und finanzielle Aktualisierungen sowie über eine Berichtigung und Abhilfemaßnahmen wegen Schwachstellen in der internen Kontrolle. Das Unternehmen geht eine Berichtigung früherer Jahresabschlüsse an und offenbart wesentliche Schwächen in der internen Kontrolle über die Finanzberichterstattung und beschreibt die ergriffenen Maßnahmen zur Behebung dieser Schwächen, darunter die Einstellung erfahrener Buchhaltungskräfte, die Implementierung eines neuen ERP-Systems und die Beauftragung einer nationalen Wirtschaftsprüfungsgesellschaft. Das Management kündigte eine strategische Umstrukturierung an, die voraussichtlich etwa 70 Mitarbeiter (~65% der Belegschaft) reduzieren wird, mit geschätzten Abfindungskosten von rund $1,5 Millionen. Zu den Finanzierungsaktivitäten gehörten mehrere Privatplatzierungen und Angebote, die Nettoerlöse von $2,5 Millionen (RTW-Privatplatzierung), $5,8 Millionen (Angebot Januar 2025) und $3,9 Millionen (Angebot Februar 2025) sowie eine Leavitt-Platzierung von $1,3 Millionen einbrachten. Das Unternehmen beschrieb eine geänderte umsatzabhängige Finanzierung, die Zahlungen von 6,0% auf bis zu 10,0% der jährlichen Nettoumsätze nach 2027 erhöht, sowie verschiedene Wandlungsmerkmale in Bezug auf PIPE- und RTW-Wandelschuldverschreibungen. Die Einreichung offenbart eine anhängige Klage mit Forderungen von etwa $2,5 Millionen und führt Produkt-, regulatorische und Kommerzialisierungsinitiativen aus, darunter ein GLP-1-Programm, Vertriebsübergänge und eine geplante multizentrische Studie in Europa.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of August 8, 2025, the registrant had
EXPLANATORY NOTE
This Quarterly Report on Form 10-Q ("Form 10-Q”) includes a restatement of certain of Allurion Technologies, Inc.'s (the “Company”) previously issued unaudited financial statements for the quarter ended June 30, 2024, which was initially included in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the Securities and Exchange Commission (the "SEC") on August 14, 2024, as further described below.
The Company previously filed Amendment No. 1 to its Annual Report on Form 10-K for the fiscal year ended December 31, 2024 with the SEC on August 19, 2025 (the “Form 10-K/A”) to restate its previously issued audited consolidated financial statements as of and for the fiscal year ended December 31, 2024. The Company also filed Amendment No. 1 to its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 with the SEC on August 19, 2025 (the “Form 10-Q/A”), to restate its previously issued unaudited consolidated financial statements as of and for the fiscal quarter ended March 31, 2025. Further, the Company is filing amendments to (i) its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as amended (together with the Form 10-K/A, the “Annual Reports”), to restate its previously issued audited consolidated financial statements as of and for the fiscal year ended December 31, 2023 and (ii) its Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2024, June 30, 2024, and September 30, 2024 (together with the 10-Q/A, the “Quarterly Reports”) to restate its previously issued unaudited condensed consolidated financial statements for the fiscal quarters ended March 31, 2024, June 30, 2024, and September 30, 2024.
The Company does not intend to amend any other reports previously filed with the SEC. Accordingly, investors and other readers should rely only on the financial information and related disclosures regarding the periods described above (the “Affected Periods”) in this Form 10-Q, such amendments to the Annual Reports and Quarterly Reports described in the preceding paragraph, and in any other future filings with the SEC (as applicable) and should not rely on the prior reports of its independent registered public accounting firm on the consolidated financial statements as of and for the years ended December 31, 2023 and 2024, as applicable, or any previously furnished or filed reports, press releases, investor presentations or similar communications relating to the Affected Periods.
Restatement Background
As described in the Company’s Current Report on Form 8-K filed with the SEC on August 14, 2025, while preparing its unaudited condensed consolidated financial statements for the quarter ended June 30, 2025, the Company identified an error (the "Error") in the Company’s historical consolidated financial statements as of and for the years ended December 31, 2023 and December 31, 2024, and the quarter and year-to-date periods ended March 31, 2024, June 30, 2024, September 30, 2024, and March 31, 2025 that caused both overstatements and understatements of Other comprehensive income (loss) as reflected in the consolidated statements of comprehensive income (loss), Other income (expense) as reflected in the consolidated statements of operations, Net income (loss) as reflected in the consolidated statements of comprehensive loss and consolidated statements of operations, and Accumulated other comprehensive income (loss) and Accumulated deficit as reflected in the consolidated balance sheets and consolidated statements of stockholders' deficit. The Company determined that the Error originated from the existing material weakness related to the lack of sufficient levels of staff with public company and technical accounting experience to maintain proper control activities and perform risk assessment and monitoring activities. These adjustments were inadvertently booked in the wrong direction consistently since the fourth quarter of 2023. The Error had no impact to revenue, gross profit, operating expenses, operating profit (loss) or cash and cash equivalents.
Additionally, the Company corrected an item that was previously identified and concluded as an immaterial error to its condensed consolidated financial statements as of and for the quarter ended June 30, 2024. This item primarily relates to Other liabilities and Other income (expense) misclassifications.
As a result, the Company is restating the accompanying condensed consolidated financial statements as of and for the quarter ended June 30, 2024.
Internal Control Considerations
Following the identification of the Error and in connection with the restatement, the Company's management has re-evaluated the effectiveness of the Company's disclosure controls and procedures and internal control over financial reporting as of June 30, 2025. The Company's management determined that the Error and the related restatements were the result of the existing material weaknesses in the Company’s internal control over financial reporting. As a result, the Company's management has concluded that the Company’s disclosure controls and procedures were not effective as of June 30, 2025. See Part I - Item 4. Controls and Procedures, in this Form 10-Q for additional information related to these material weaknesses in internal control over financial reporting and the related remedial measures.
i
Table of Contents
|
|
Page |
|
|
|
PART I. |
FINANCIAL INFORMATION |
1 |
|
|
|
Item 1. |
Financial Statements (Unaudited) |
1 |
|
Condensed Consolidated Balance Sheets (Restated) |
1 |
|
Condensed Consolidated Statements of Operations (Restated) |
2 |
|
Condensed Consolidated Statements of Comprehensive Income (Loss) (Restated) |
3 |
|
Condensed Consolidated Statements of Stockholders’ Deficit (Restated) |
4 |
|
Condensed Consolidated Statements of Cash Flows (Restated) |
5 |
|
Notes to Unaudited Condensed Consolidated Financial Statements (Restated) |
7 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
41 |
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
55 |
Item 4. |
Controls and Procedures |
55 |
|
|
|
PART II. |
OTHER INFORMATION |
57 |
|
|
|
Item 1. |
Legal Proceedings |
57 |
Item 1A. |
Risk Factors |
57 |
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
59 |
Item 3. |
Defaults Upon Senior Securities |
59 |
Item 4. |
Mine Safety Disclosures |
59 |
Item 5. |
Other Information |
59 |
Item 6. |
Exhibits |
60 |
Signatures |
62 |
|
ii
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements, which are not purely historical, include, but are not limited to, statements regarding the plans, strategies and prospects, both business and financial, of Allurion Technologies, Inc. (“Allurion”, the "Company", "we", "our", or "us"). Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors. Such risks, uncertainties and other factors could cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.
Generally, statements that are not historical facts, including statements concerning possible or assumed future actions, business strategies, events, or results of operations, are forward-looking statements. These statements may be preceded by, followed by or include the words “believes”, “estimates”, “expects”, “projects”, “target”, “goal”, “forecasts”, “may”, “will”, “potential”, “should”, “would”, “could”, “future”, “seeks”, “plans”, “predicts”, “propose”, “scheduled”, “anticipates”, “intends”, or similar expressions. Such statements are based on the beliefs and assumptions of the management of Allurion. Although Allurion believes that its plans, intentions and expectations reflected in or suggested by these forward-looking statements are reasonable, Allurion cannot assure you that it will achieve or realize these plans, intentions or expectations.
Forward-looking statements in this Quarterly Report on Form 10-Q include, but are not limited to, statements about the ability of Allurion to:
iii
We have based the forward-looking statements contained in this Quarterly Report on Form 10-Q primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy, and financial needs. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties, assumptions and other factors described under the heading “Risk Factors” in this Quarterly Report on Form 10-Q and in the section entitled “Risk Factors” within our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (the "SEC") on March 27, 2025, as amended by Amendment No. 1 to the Annual Report on Form 10-K filed with the SEC on August 19, 2025 (together, the “Annual Report on 10-K”). These risks are not exhaustive. Other sections of this Quarterly Report on Form 10-Q include additional factors that could adversely impact our business and financial performance. Moreover, Allurion operates in very competitive and rapidly changing environments. New risks and uncertainties emerge from time to time and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Quarterly Report on Form 10-Q.
We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and such statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities laws.
iv
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
ALLURION TECHNOLOGIES, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(dollars in thousands)
|
|
June 30, |
|
|
December 31, |
|
||
|
|
|
|
|
(Restated) |
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Accounts receivable, net of allowance of doubtful accounts of $ |
|
|
|
|
|
|
||
Inventory, net |
|
|
|
|
|
|
||
Prepaid expenses and other current assets |
|
|
|
|
|
|
||
Total current assets |
|
|
|
|
|
|
||
Property and equipment, net |
|
|
|
|
|
|
||
Right-of-use asset |
|
|
|
|
|
|
||
Other long-term assets |
|
|
|
|
|
|
||
Total assets |
|
$ |
|
|
$ |
|
||
Liabilities and Stockholders’ Deficit |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
|
|
$ |
|
||
Current portion of lease liabilities |
|
|
|
|
|
|
||
Accrued expenses and other current liabilities |
|
|
|
|
|
|
||
Total current liabilities |
|
|
|
|
|
|
||
Warrant liabilities |
|
|
|
|
|
|
||
Revenue Interest Financing liability |
|
|
|
|
|
|
||
Earn-out liabilities |
|
|
|
|
|
|
||
Convertible notes payable |
|
|
|
|
|
|
||
Lease liabilities, net of current portion |
|
|
|
|
|
|
||
Other liabilities |
|
|
|
|
|
|
||
Total liabilities |
|
|
|
|
|
|
||
Commitments and Contingencies (Note 17) |
|
|
|
|
|
|
||
Stockholders’ deficit: |
|
|
|
|
|
|
||
Preferred stock, $ |
|
|
— |
|
|
|
— |
|
Common stock, $ |
|
|
|
|
|
|
||
Additional paid-in capital |
|
|
|
|
|
|
||
Accumulated other comprehensive (loss) income |
|
|
|
|
|
( |
) |
|
Accumulated deficit |
|
|
( |
) |
|
|
( |
) |
Total stockholders’ deficit |
|
|
( |
) |
|
|
( |
) |
Total liabilities and stockholders’ deficit |
|
$ |
|
|
$ |
|
||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
1
ALLURION TECHNOLOGIES, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(dollars in thousands, except per share amounts)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
|
|
|
|
|
(Restated) |
|
|
|
|
|
(Restated) |
|
||||
Revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Cost of revenue |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Gross profit |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Sales and marketing |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Loss from operations |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest expense |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
Changes in fair value of warrants |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Changes in fair value of debt |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
|
||
Changes in fair value of Revenue Interest Financing and PIPE Conversion Option |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
Changes in fair value of earn-out liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Loss on extinguishment of debt |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Other income (expense), net |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total other income (expense): |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Loss before income taxes |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Provision for income taxes |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Net loss per share |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Weighted-average shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
ALLURION TECHNOLOGIES, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(dollars in thousands)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
|
|
|
|
|
(Restated) |
|
|
|
|
|
(Restated) |
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Other comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Change in fair value of Revenue Interest Financing due to change in credit risk |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Change in fair value of RTW Convertible Notes due to change in credit risk |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Comprehensive income (loss) |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
ALLURION TECHNOLOGIES, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
(dollars in thousands)
|
|
Common Stock |
|
|
Additional Paid- |
|
|
Accumulated Other |
|
|
Accumulated |
|
|
Stockholders’ |
|
|||||||||
|
|
Shares |
|
|
Amount |
|
|
in Capital |
|
|
Comprehensive Loss |
|
|
Deficit |
|
|
Deficit |
|
||||||
Balance as of January 1, 2024 (Restated) |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||
Exercise of stock options |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Issuance of common stock for the exercise of Public Warrants |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Issuance of common stock from equity line financing (Note 13) |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Issuance of common stock in connection with vesting of RSU awards |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Other comprehensive loss (Restated) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|||
Net income (Restated) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Balance as of March 31, 2024 (Restated) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
||||
Exercise of stock options |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Issuance of common stock in connection with vesting of RSU awards |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Issuance of common stock for the exercise of Public Warrants |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Other comprehensive loss (Restated) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss (Restated) |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
Balance as of June 30, 2024 (Restated) |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Balance as of January 1, 2025 (Restated) |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|||
Exercise of stock options |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Issuance of common stock in connection with vesting of RSU awards |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Issuance of common stock in connection with RTW Private Placement, net of issuance costs |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Issuance of common stock in connection with January Public Offering, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Issuance of common stock in connection with February Public Offering and Leavitt Private Placement, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Other comprehensive loss (Restated) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss (Restated) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance as of March 31, 2025 (Restated) |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|||
Exercise of stock options |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
||
Issuance of common stock in connection with vesting of RSU awards |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Issuance of common stock from equity line financing (Note 13) |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Issuance of common stock from conversion of RTW Convertible Notes |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance as of June 30, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
ALLURION TECHNOLOGIES, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(dollars in thousands)
|
|
Six Months Ended June 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
|
|
|
|
|
(Restated) |
|
||
Operating Activities: |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: |
|
|
|
|
|
|
||
Non-cash lease expense |
|
|
|
|
|
|||
Depreciation and amortization |
|
|
|
|
|
|||
Stock-based compensation |
|
|
|
|
|
|
||
Provision for uncollectible accounts |
|
|
|
|
|
— |
|
|
Provision for inventory |
|
|
|
|
|
|
||
Change in fair value of warrant liabilities |
|
|
( |
) |
|
|
( |
) |
Change in fair value of derivative liabilities |
|
|
— |
|
|
|
( |
) |
Change in fair value of Revenue Interest Financing and PIPE Conversion Option |
|
|
|
|
|
|
||
Change in fair value of earn-out liabilities |
|
|
( |
) |
|
|
( |
) |
Interest paid on debt recorded at fair value |
|
|
( |
) |
|
|
( |
) |
Change in fair value of debt |
|
|
|
|
|
( |
) |
|
Change in fair value of Share Obligation |
|
|
|
|
|
— |
|
|
Debt issuance costs associated with debt recorded at fair value |
|
|
— |
|
|
|
|
|
Non-cash interest expense |
|
|
— |
|
|
|
|
|
Issuance costs associated with warrants recorded at fair value |
|
|
|
|
|
— |
|
|
Loss on debt extinguishment |
|
|
|
|
|
|
||
Other non-cash items, net |
|
|
( |
) |
|
|
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Accounts receivable |
|
|
|
|
|
|
||
Inventory |
|
|
( |
) |
|
|
|
|
Prepaid expenses, other current and long-term assets |
|
|
|
|
|
|
||
Lease liabilities |
|
|
( |
) |
|
|
( |
) |
Accounts payable |
|
|
( |
) |
|
|
( |
) |
Accrued expenses and other current liabilities |
|
|
( |
) |
|
|
( |
) |
Net cash used in operating activities |
|
$ |
( |
) |
|
$ |
( |
) |
Investing Activities: |
|
|
|
|
|
|
||
Purchases of property and equipment |
|
|
— |
|
|
|
( |
) |
Net cash used in investing activities |
|
$ |
— |
|
|
$ |
( |
) |
Financing Activities: |
|
|
|
|
|
|
||
Proceeds from issuance of convertible notes |
|
|
— |
|
|
|
|
|
Proceeds from option and warrant exercises |
|
|
— |
|
|
|
|
|
Proceeds from equity line financing |
|
|
|
|
|
|
||
Proceeds from Public Offering, net of issuance costs |
|
|
|
|
|
— |
|
|
Payment of debt issuance costs |
|
|
— |
|
|
|
( |
) |
Repayment of Fortress term loan |
|
|
— |
|
|
|
( |
) |
Net cash provided by (used in) financing activities |
|
$ |
|
|
$ |
( |
) |
|
Net decrease in cash and cash equivalents and restricted cash |
|
|
( |
) |
|
|
( |
) |
Cash and cash equivalents and restricted cash at beginning of period |
|
|
|
|
|
|
||
Cash and cash equivalents and restricted cash at end of period |
|
$ |
|
|
$ |
|
||
Supplemental disclosure of cash flow information |
|
|
|
|
|
|
||
Cash paid for interest |
|
$ |
— |
|
|
$ |
|
|
Supplemental cash flow information on non-cash investing and financing activities |
|
|
|
|
|
|
||
Purchase of property and equipment included in accounts payable |
|
$ |
— |
|
|
$ |
|
|
Transaction costs in accounts payable and accrued expenses |
|
|
|
|
|
— |
|
|
Deferred financing costs in accounts payable and accrued expenses |
|
|
— |
|
|
|
|
|
Change in fair value of RTW Convertible Notes through OCI |
|
|
|
|
|
|
||
Change in fair value of Revenue Interest Financing through OCI |
|
|
|
|
|
|
||
Common stock issued for conversion of convertible notes |
|
|
|
|
|
— |
|
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
ALLURION TECHNOLOGIES, INC. AND SUBSIDIARIES
A reconciliation of the amounts of cash and cash equivalents and restricted cash in the consolidated balance sheets to the amount in the consolidated statements of cash flows is as follows (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Restricted cash included in other long-term assets |
|
|
|
|
|
|
||
Cash and cash equivalents and restricted cash shown in the statement of cash flows |
|
$ |
|
|
$ |
|
||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
Organization
Allurion Technologies, Inc. (“Allurion” or the “Company”) is a vertically integrated medical device company that is developing, manufacturing, and commercializing innovative weight loss experiences centered around its Allurion™ Balloon. The Allurion Balloon is the world’s first and only swallowable, procedureless™ intragastric balloon for weight loss that does not require surgery, endoscopy, or anesthesia for placement. Allurion sells the Allurion Balloon and connected scale through distributors or directly to health care providers.
The Company also offers tiered access to artificial intelligence (“AI”)-powered remote patient monitoring tools, a mobile app for patients and a clinic dashboard for providers, referred to as the Allurion Virtual Care Suite (“VCS”) and, collectively with the Allurion Balloon, referred to as the “Allurion Program.” The base tier of the VCS is free of charge to those purchasing the Allurion Balloon, as well as customers looking for a weight-loss management platform for patients utilizing other weight loss treatments, including anti-obesity medications and bariatric surgery. More full-scale versions of the VCS are available to health care providers on an upgrade basis. Allurion currently markets the Allurion Program in over
Business Combination Agreement
On February 9, 2023, Allurion Technologies Opco, Inc. (formerly Allurion Technologies, Inc., “Legacy Allurion”) and Allurion Technologies, Inc. (formerly Allurion Technologies Holdings, Inc.) entered into the Business Combination Agreement (as subsequently amended on May 2, 2023, the “Business Combination Agreement”) with Compute Health Acquisition Corp. (“CPUH” or "Compute Health"), Compute Health Corp. (“Merger Sub I”) and Compute Health LLC (“Merger Sub II” and, together with Merger Sub I, the “Merger Subs”). Pursuant to the Business Combination Agreement, on August 1, 2023 (the “Closing Date”), the Mergers (as defined below) were consummated in three steps: (a) Compute Health merged with and into Allurion (the “CPUH Merger”), with Allurion surviving the CPUH Merger as a publicly listed entity (the time at which the CPUH Merger became effective, the “CPUH Merger Effective Time”) and becoming the sole owner of the Merger Subs; (b) three hours following the consummation of the CPUH Merger, Merger Sub I merged with and into Legacy Allurion (the “Intermediate Merger” and the time at which the Intermediate Merger became effective, the “Intermediate Merger Effective Time”), with Legacy Allurion surviving the Intermediate Merger and becoming a direct, wholly-owned subsidiary of Allurion; and (c) thereafter, Legacy Allurion merged with and into Merger Sub II (the “Final Merger” and, collectively with the CPUH Merger and the Intermediate Merger, the “Mergers”, and together with all other transactions contemplated by the Business Combination Agreement, the “Business Combination”), with Merger Sub II surviving the Final Merger and remaining a direct, wholly-owned subsidiary of Allurion. Allurion shares began trading on the New York Stock Exchange ("NYSE") under the ticker symbol “ALUR” on August 2, 2023. Upon completion of the Business Combination, Legacy Allurion's business operations continued as our business operations.
The Business Combination was accounted for as a reverse capitalization in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Under this method of accounting, Compute Health was treated as the “acquired” company for financial reporting purposes and Legacy Allurion was the accounting “acquirer”. Accordingly, the Business Combination was treated as the equivalent of Legacy Allurion issuing stock for the net assets of Compute Health, accompanied by a recapitalization. As a result of the reverse recapitalization, the assets and liabilities of the Company are presented at their historical carrying values, and the assets and liabilities of Compute Health are recognized on the acquisition date and measured on the basis of the net proceeds from the capital transaction, with no goodwill or other intangible assets recorded. This determination is primarily based on the fact that, immediately following the Business Combination, Legacy Allurion stockholders had a majority of the voting power of Allurion, Legacy Allurion controlled the majority of the board seats of Allurion, and Legacy Allurion senior management comprised all of the senior management of Allurion. The equity structure has been restated in all comparative periods up to the Closing Date to reflect the number of shares of the Company's common stock, $
Unless otherwise indicated, references in this Quarterly Report on Form 10-Q to the "Company", "our", and "Allurion" refer to the condensed consolidated operations of Allurion Technologies, Inc. and its subsidiaries after giving effect to the Business Combination. References to CPUH and Compute Health refer to Compute Health Acquisition Corp. and its subsidiaries prior to the consummation of the Business Combination and references to "Legacy Allurion" refer to Allurion Technologies, Inc. prior to the consummation of the Business Combination.
7
Basis of Presentation
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. GAAP and the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). Any reference in these notes to the applicable accounting guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification ("ASC"), and Accounting Standards Update ("ASU"), of the Financial Accounting Standards Board ("FASB"). They should be read in conjunction with our audited financial statements as of and for the year ended December 31, 2024 included in the Company's Annual Report on Form 10-K filed with the SEC on March 27, 2025, as amended by Amendment No. 1 to the Annual Report on Form 10-K filed with the SEC on August 19, 2025 (together the "Annual Report on Form 10-K"). The financial statements as of June 30, 2025 and for the three and six months ended June 30, 2025 and 2024 presented in this report are unaudited; however, in the opinion of management such financial statements reflect all adjustments, consisting solely of normal recurring adjustments, necessary for a fair presentation of the results for the interim periods presented. The results of operations for the periods presented are not necessarily indicative of the results that might be expected for future interim periods or for the full year.
Our foreign operations are subject to exchange rate fluctuations and foreign currency transaction costs. The functional currency for all of our foreign subsidiaries is the United States dollar except Allurion Australia Pty Ltd., which uses the Australian dollar. When remeasuring from a local currency to the functional currency, assets and liabilities are remeasured into U.S. dollars at exchange rates in effect at the balance sheet dates and results of operations transacted in local currency are remeasured into U.S. dollars using average exchange rates for the period presented. Gain (losses) from remeasurement of $
Reverse Stock Split
As a result of the Reverse Stock Split, every
No fractional shares were issued in connection with the Reverse Stock Split. Stockholders who would otherwise be entitled to receive fractional shares as a result of the Reverse Stock Split were automatically entitled to receive an additional fraction of a share of Common Stock to round up to the next whole share.
Proportional adjustments were also made to the number of shares of Common Stock awarded and available for issuance under the Company’s equity incentive plans, as well as the exercise price and the number of shares issuable upon the exercise or conversion of the Company’s outstanding stock options, restricted stock units and other equity securities under the Company’s equity incentive plans. Additionally, all outstanding convertible notes were adjusted in accordance with their terms, which resulted, among other changes to the convertible note terms, in proportionate adjustments being made to the number of shares issuable upon exercise of such convertible notes and to the exercise and redemption prices of such convertible notes. All outstanding warrants were also adjusted in accordance with their terms, which resulted, among other changes to the warrant terms, in proportionate adjustments being made to the number of shares issuable upon exercise of such warrants and to the exercise and redemption prices of such warrants. Specifically, following the effectiveness of the Reverse Stock Split, every
Unless otherwise indicated, all authorized, issued, and outstanding shares and per share amounts contained in the accompanying condensed consolidated financial statements have been adjusted to reflect the 1-for-25 Reverse Stock Split for all periods presented. As a result, net income per share was also retrospectively adjusted for periods ended prior to the Reverse Stock Split.
Going Concern
8
The Company has evaluated whether there are certain events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the interim condensed consolidated financial statements included in this Quarterly Report on Form 10-Q are issued.
The Company has incurred recurring losses since inception, anticipates net losses and negative operating cash flows for the near future, and may be unable to remain in compliance with certain financial covenants required under its credit facilities. Through June 30, 2025, the Company has funded its operations primarily with proceeds from the sale of its Common Stock and convertible preferred stock, issuance of convertible notes, issuance of term loans, and funds received upon consummation of the Business Combination. The Company has incurred recurring losses and cash outflows from operating activities since its inception, including losses from operations of $
Until such time as we can generate sufficient revenue to fund operations, we expect to use proceeds from the issuance of equity, debt financings, or other capital transactions to fund our operations and satisfy our liquidity requirements, but the amount and timing of such financings are uncertain. Based on the Company's recurring losses from operations incurred since inception, its expectation of continuing operating losses for the foreseeable future, the need to raise additional capital to finance its future operations, and the potential of being unable to remain in compliance with certain financial covenants under its credit facilities, the Company has concluded that there is substantial doubt about its ability to continue as a going concern for a period of one year from the date that these condensed consolidated financial statements are issued. The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business.
2. Restatement of Previously Issued Financial Statements
While preparing its unaudited condensed consolidated financial statements for the quarter ended June 30, 2025, the Company identified an error (the "Error") in the Company’s historical consolidated financial statements as of and for the years ended December 31, 2023 and December 31, 2024, and the quarter and year-to-date periods ended March 31, 2024, June 30, 2024, September 30, 2024, and March 31, 2025, that caused both overstatements and understatements of Other comprehensive income (loss) as reflected in the consolidated statements of comprehensive income (loss), Other income (expense) as reflected in the consolidated statements of operations, Net income (loss) as reflected in the consolidated statements of comprehensive loss and consolidated statements of operations, and Accumulated other comprehensive income (loss) and Accumulated deficit as reflected in the consolidated balance sheets and consolidated statements of stockholders' deficit. The Company determined that the Error originated from the existing material weakness related to the lack of sufficient levels of staff with public company and technical accounting experience to maintain proper control activities and perform risk assessment and monitoring activities. These adjustments were inadvertently booked in the wrong direction consistently since the fourth quarter of 2023. The Error had no impact to revenue, gross profit, operating expenses, operating loss, or cash and cash equivalents.
Additionally, the Company corrected an item that was previously identified and concluded as an immaterial error to its condensed consolidated financial statements as of and for the six months ended June 30, 2024. This item primarily relates to Other liabilities and Other Income (Expense) misclassifications.
As a result, the Company is restating the accompanying condensed consolidated financial statements as of and for the quarter ended June 30, 2024.
The effects of the restatements on the condensed consolidated financial statements for the three and six months ended June 30, 2024, are as follows:
Restated Condensed Consolidated Statement of Operations
(dollars in thousands)
9
|
|
Three months ended June 30, 2024 |
|
|
Six months ended June 30, 2024 |
|
||||||||||||||||||
|
|
As Reported |
|
|
Adjustment |
|
|
As Restated |
|
|
As Reported |
|
|
Adjustment |
|
|
As Restated |
|
||||||
Revenue |
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
||||
Cost of revenue |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
Gross profit |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Sales and marketing |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
Research and development |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
General and administrative |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
Total operating expenses: |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
Loss from operations |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Interest expense |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Changes in fair value of warrants |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
Changes in fair value of debt |
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
||||
Changes in fair value of Revenue Interest Financing and PIPE Conversion Option |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
( |
) |
||
Changes in fair value of earn-out liabilities |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
Loss on extinguishment of debt |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Other income (expense), net |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
Total other income (expense): |
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
||||
Income (loss) before income taxes |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
Provision for income taxes |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Net income (loss) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
Net income (loss) per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Basic |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
Diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
Weighted-average shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Basic |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
Diluted |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
||||
Restated Condensed Consolidated Statement of Comprehensive Loss
(dollars in thousands)
|
|
Three months ended June 30, 2024 |
|
|
Six months ended June 30, 2024 |
|
||||||||||||||||||
|
|
As Reported |
|
|
Adjustment |
|
|
As Restated |
|
|
As Reported |
|
|
Adjustment |
|
|
As Restated |
|
||||||
Net income (loss) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Change in fair value of Revenue Interest Financing due to change in credit risk |
|
|
( |
) |
|
|
|
|
$ |
|
|
|
( |
) |
|
|
|
|
|
|
||||
Change in fair value of RTW Convertible Notes due to change in credit risk |
|
|
( |
) |
|
|
|
|
$ |
|
|
|
( |
) |
|
|
|
|
|
|
||||
Comprehensive Income (loss) |
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
Restated Condensed Consolidated Statement of Cash Flows
(dollars in thousands)
10
|
|
Six Months Ended June 30, 2024 |
|
|||||||||
|
|
Originally Reported |
|
|
Adjustment |
|
|
As Restated |
|
|||
Operating Activities: |
|
|
|
|
|
|
|
|
|
|||
Net income (loss) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
Adjustments to reconcile net income (loss) to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
|||
Non-cash lease expense |
|
|
|
|
|
— |
|
|
|
|||
Depreciation and amortization |
|
|
|
|
|
— |
|
|
|
|||
Stock-based compensation |
|
|
|
|
|
— |
|
|
|
|
||
Unrealized exchange (gain) or loss |
|
|
|
|
|
— |
|
|
|
|
||
Provision for inventory |
|
|
|
|
|
— |
|
|
|
|
||
Change in fair value of warrant liabilities |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Change in fair value of derivative liabilities |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Change in fair value of Revenue Interest Financing and PIPE Conversion Option |
|
|
( |
) |
|
|
|
|
|
|
||
Change in fair value of earn-out liabilities |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Interest paid on debt recorded at fair value |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Change in fair value of debt |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
Debt issuance costs associated with debt recorded at fair value |
|
|
|
|
|
— |
|
|
|
|
||
Non-cash interest expense |
|
|
|
|
|
— |
|
|
|
|
||
Loss on term loan extinguishment |
|
|
|
|
|
— |
|
|
|
|
||
Changes in operating assets and liabilities: |
|
|
|
|
|
— |
|
|
|
|
||
Accounts receivable |
|
|
|
|
|
— |
|
|
|
|
||
Inventory |
|
|
|
|
|
— |
|
|
|
|
||
Prepaid expenses, other current and long-term assets |
|
|
|
|
|
— |
|
|
|
|
||
Lease liabilities |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Accounts payable |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Accrued expenses and other current liabilities |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Net cash used in operating activities |
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
( |
) |
Investing Activities: |
|
|
|
|
|
|
|
|
|
|||
Purchases of property and equipment |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Net cash used in investing activities |
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
( |
) |
Financing Activities: |
|
|
|
|
|
|
|
|
|
|||
Proceeds from issuance of convertible notes |
|
|
|
|
|
— |
|
|
|
|
||
Proceeds from option and warrant exercises |
|
|
|
|
|
— |
|
|
|
|
||
Proceeds from equity line financing |
|
|
|
|
|
— |
|
|
|
|
||
Repayment of convertible notes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
Payment of deferred financing costs |
|
|
— |
|
|
|
— |
|
|
|
— |
|
Payment of debt issuance costs |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Repayment of Fortress term loan |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Net cash provided by (used in) financing activities |
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
( |
) |
Net decrease in cash and cash equivalents and restricted cash |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Cash and cash equivalents and restricted cash at beginning of period |
|
|
|
|
|
— |
|
|
|
|
||
Cash and cash equivalents and restricted cash at end of period |
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
Supplemental disclosure of cash flow information |
|
|
|
|
|
|
|
|
|
|||
Cash paid for interest |
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
Supplemental cash flow information on non-cash investing and financing activities |
|
|
|
|
|
|
|
0 |
|
|||
Purchase of property and equipment included in accounts payable |
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
Deferred financing costs in accounts payable and accrued expenses |
|
|
|
|
|
— |
|
|
|
|
||
Change in fair value of RTW Convertible Notes through OCI |
|
|
|
|
|
|
|
|
|
|||
Change in fair value of Revenue Interest Financing through OCI |
|
|
( |
) |
|
|
|
|
|
|
||
11
3. Summary of Significant Accounting Policies
There have been no significant changes to the significant accounting policies disclosed in Note 3 of the “Notes to Consolidated Financial Statements” to the consolidated audited financial statements as of and for the year ended December 31, 2024 included in our Annual Report on Form 10-K.
Use of Estimates
The preparation of these condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. Management considers many factors in selecting appropriate financial accounting policies and controls in developing the estimates and assumptions that are used in the preparation of these condensed consolidated financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Actual results could differ from those estimates.
Risk of Concentration of Credit, Significant Customers and Significant Suppliers
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash equivalents and accounts receivable, net. The Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company maintains its cash, cash equivalents and restricted cash with financial institutions that management believes to be of high credit quality. The Company has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
Significant customers are those that represent more than
|
|
Revenue |
|
Revenue |
|
Accounts Receivable |
|
|||||||||
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
June 30, |
|
|
December 31, |
|
||||||
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
2025 |
|
|
2024 |
|
||
Customer A |
|
N/A |
|
N/A |
|
N/A |
|
N/A |
|
|
% |
|
N/A |
|
||
Customer B |
|
N/A |
|
N/A |
|
N/A |
|
N/A |
|
|
% |
|
N/A |
|
||
Customer C |
|
N/A |
|
N/A |
|
N/A |
|
N/A |
|
N/A |
|
|
|
% |
||
The Company relies on third parties for the supply of parts and components for its products as well as third-party logistics providers. In instances where these parties fail to perform their obligations, the Company may be unable to find alternative suppliers of parts and components to satisfactorily deliver its products to its customers on time, if at all, which could have a material adverse effect on the Company’s operating results, financial condition and cash flows and damage its customer relationships.
Recently Adopted Accounting Pronouncements
In August 2020, the FASB issued ASU 2020-06, Debt with Conversion and Other Options and Derivatives and Hedging—Contracts in Entity’s Own Equity, which simplifies the accounting for convertible instruments. The guidance removes certain accounting models which separate the embedded conversion features from the host contract for convertible instruments. The Company
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires disclosure of incremental segment information on an interim and annual basis. The Company
Recently Issued Accounting Pronouncements Not Yet Adopted
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. This ASU is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The adoption of this standard is not expected to have a material impact on the Company's condensed consolidated financial statements and related disclosures.
12
4. Business Combination
As discussed in Note 1, Organization and Basis of Presentation, on August 1, 2023 the Company consummated the Business Combination with Compute Health pursuant to the Business Combination Agreement. The Business Combination was accounted for as a reverse capitalization in accordance with U.S. GAAP. Under this method of accounting, Compute Health, which was the legal acquirer, was treated as the “acquired” company for financial reporting purposes. Accordingly, the Business Combination was treated as the equivalent of Allurion issuing stock for the net assets of Compute Health, accompanied by a recapitalization.
Upon the closing of the Business Combination, (a) holders of Legacy Allurion common stock received shares of Allurion Common Stock in an amount determined by application of the Exchange Ratio of approximately
Further, upon the closing of the Business Combination, each then-outstanding share of Compute Health Class A common stock was canceled and extinguished and was converted into the right to receive
In connection with the Business Combination, the Company incurred approximately $
The following table reconciles the elements of the Business Combination to the condensed consolidated statement of cash flows and the condensed consolidated statement of changes in equity:
|
|
December 31, 2023 |
|
|
Cash – CPUH trust (net of redemptions) |
|
$ |
|
|
Cash – PIPE Investors |
|
|
|
|
Gross Proceeds |
|
|
|
|
Less: transaction costs paid |
|
|
( |
) |
Net proceeds from the Business Combination |
|
|
|
|
Less: warrant liabilities assumed |
|
|
( |
) |
Less: repayment of note assumed in the Business Combination |
|
|
( |
) |
Less: accrued transaction costs at December 31, 2023 |
|
|
( |
) |
Business Combination, net of transaction costs |
|
$ |
|
|
13
The number of shares of Allurion Common Stock outstanding immediately following the consummation of the Business Combination was as follows:
|
|
Common Stock |
|
|
Legacy Allurion Equityholders (1) |
|
|
|
|
CPUH Stockholders (2) |
|
|
|
|
Shares Issued to PIPE Investors (2) |
|
|
|
|
Shares issued to RTW and Fortress (3) |
|
|
|
|
Shares issued to convertible note holders |
|
|
|
|
CPUH Sponsor Shares (2) |
|
|
|
|
Side Letter Termination Shares (3) |
|
|
|
|
Total shares of Common Stock immediately after |
|
|
|
|
(1) Consists of Legacy Allurion common stock and Legacy Allurion preferred stock, plus the issuance of Allurion Common Stock in connection with the vesting of RSUs at closing, less the Gaur Trust Contributed Shares (as defined below).
(2) The CPUH Stockholders shares, PIPE shares, and CPUH Sponsor shares are presented combined within the condensed consolidated statements of stockholders deficit on the "Reverse recapitalization, net of transaction costs" line, which is less the Gaur Trust Contributed Shares (as defined below).
(3) The shares issued to RTW and Fortress and the Side Letter Termination shares are presented combined within the condensed consolidated statements of stockholders deficit on the "Derecognition of liabilities associated with the Backstop Shares, Hunter shares, and additional RTW and Fortress shares and issuance of related shares" line.
PIPE Investment
In connection with the execution of the Business Combination Agreement, Allurion and Compute Health entered into subscription agreements, each dated February 9, 2023, with certain accredited investors and qualified institutional buyers (the “PIPE Investors”), pursuant to which, upon the terms and subject to the conditions set forth therein, the PIPE Investors, among other things, purchased an aggregate of
Revenue Interest Financing Agreement, Side Letter and PIPE Conversion Option
On February 9, 2023, concurrently with the execution of the Business Combination Agreement, the Company entered into the Revenue Interest Financing Agreement (as amended, the "Revenue Interest Financing Agreement") with certain entities that engaged RTW Investments, LP (together with its affiliates, "RTW") as investment manager (the "Revenue Interest Financing"). Pursuant to the Revenue Interest Financing Agreement, at the closing of the Business Combination, RTW paid Allurion an aggregate of $
Additionally, in connection with the Company entering in the Revenue Interest Financing Agreement, the Company, Compute Health, Legacy Allurion, Merger Sub II and RTW entered into a side letter (the "RTW Side Letter") on February 9, 2023 under which RTW was granted the right to elect to convert up to $
On May 2, 2023, the parties amended and restated the RTW Side Letter (as amended, the "Amended and Restated RTW Side Letter"), in connection with the Backstop Agreement (defined below), pursuant to which, among other things, Allurion issued
On October 22, 2024, funds affiliated with RTW provided notice to the Company of their election under the Amended and Restated RTW Side Letter, to surrender
14
Fortress Credit Agreement
In connection with the closing of the Business Combination, the Company entered into a term loan facility (the “Fortress Term Loan”) pursuant to a Credit Agreement and Guaranty, dated as of August 1, 2023 (the “Fortress Credit Agreement”), with Fortress Credit Corp. (“Fortress”), as administrative agent for the lenders party thereto from time to time. Under the terms of the Fortress Term Loan, the Company borrowed $
Backstop Agreement
On May 2, 2023, CFIP2 ALLE LLC, an affiliate of Fortress Credit Corp., and RTW (collectively, the “Backstop Purchasers”), Legacy Allurion, Allurion and Hunter Ventures Limited (“HVL”) entered into the backstop agreement (the “Backstop Agreement”). Pursuant to the Backstop Agreement, immediately prior to the Intermediate Merger Closing, (a) each Backstop Purchaser purchased $
HVL Termination Agreement
On May 2, 2023, HVL and Legacy Allurion entered into a letter agreement (the “HVL Termination Agreement”), terminating the side letter agreement entered into between Legacy Allurion and HVL in connection with the issuance of HVL’s Legacy Allurion convertible note on February 15, 2023. Pursuant to the HVL Termination Agreement, among other things, at the closing of the Business Combination, upon the terms and subject to the conditions set forth therein, Allurion issued to HVL
Gaur Contribution Agreement
On May 2, 2023, Shantanu K. Gaur and Neha Gaur, trustees of The Shantanu K. Gaur Revocable Trust of 2021 (the “Gaur Trust”) and Allurion entered into a contribution agreement (the “Gaur Contribution Agreement”), pursuant to which, among other things, upon the terms and subject to the conditions set forth therein, the Gaur Trust contributed to Allurion, as a contribution of capital,
RSU Forfeiture Agreement
On May 2, 2023, Krishna Gupta, a member of the Board, entered into a letter agreement with Legacy Allurion (the “RSU Forfeiture Agreement”), pursuant to which, among other things, upon the terms and subject to the conditions set forth therein, Mr. Gupta agreed to forfeit
Sponsor Contribution Agreement
On May 2, 2023, the Sponsor and Compute Health entered into a letter agreement (the "Sponsor Contribution Agreement") pursuant to which, among other things, upon the terms and subject to the conditions set forth therein, the Sponsor agreed to contribute to Compute Health, as a contribution of capital,
Sponsor Support Agreement
On February 9, 2023, Allurion entered into a support agreement (the "Sponsor Support Agreement"), pursuant to which immediately prior to the CPUH Merger Effective time, (a) the Sponsor recapitalized each of the Sponsor’s
15
Conversion of Convertible Notes
In connection with the closing of the Business Combination, outstanding Legacy Allurion convertible notes with an aggregate principal amount together with accrued but unpaid interest of approximately $
Public Warrants and Warrant Amendment
In connection with the closing of the Business Combination, the Company assumed
Earn-Out Liabilities
In connection with the closing of the Business Combination, Legacy Allurion equity holders are entitled to receive additional shares of Allurion Common Stock if the share price achieves certain targets (the "Earn-Out Shares"). The Company accounts for the potential issuance of the Earn-Out Shares as a contingent consideration arrangement, which was initially valued and recorded at $
5. Revenue
Revenue by geographic region is based on the country in which our customer is located and is summarized by geographic area as follows (in thousands):
|
|
Three Months Ended June 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Spain |
|
$ |
|
|
$ |
|
||
Italy |
|
|
|
|
|
|
||
France |
|
|
|
|
|
|
||
All Other Countries |
|
|
|
|
|
|
||
Total Revenues |
|
$ |
|
|
$ |
|
||
For the three months ended June 30, 2025, $
|
|
Six Months Ended June 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Spain |
|
$ |
|
|
$ |
|
||
France |
|
|
|
|
|
|
||
United Kingdom |
|
|
|
|
|
|
||
All Other Countries |
|
|
|
|
|
|
||
Total Revenues |
|
$ |
|
|
$ |
|
||
For the six months ended June 30, 2025, $
16
Remaining revenue was generated by sales in
6. Inventory
Inventory consists of the following (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
Finished goods |
|
$ |
|
|
$ |
|
||
Work in progress |
|
|
|
|
|
|
||
Raw materials |
|
|
|
|
|
|
||
Total Inventory |
|
$ |
|
|
$ |
|
||
Inventory is stated net of $
7. Property and Equipment, net
Property and equipment consist of the following (in thousands):
|
|
Estimated Useful Life |
|
June 30, |
|
|
December 31, |
|
||
Computers and purchased software |
|
|
$ |
|
|
$ |
|
|||
Leasehold improvements |
|
Shorter of useful life |
|
|
|
|
|
|
||
Furniture and fixtures |
|
|
|
|
|
|
|
|||
Machinery and equipment |
|
|
|
|
|
|
|
|||
Property and equipment—at cost |
|
|
|
|
|
|
|
|
||
Less accumulated depreciation and amortization |
|
|
|
|
( |
) |
|
|
( |
) |
Construction in progress |
|
|
|
|
|
|
|
|
||
Property and equipment—net |
|
|
|
$ |
|
|
$ |
|
||
Depreciation expense was $
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
2025 |
|
|
2024 |
|
||||
Cost of revenue |
|
$ |
|
|
$ |
|
$ |
|
|
$ |
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
||||
Sales and marketing |
|
|
|
|
|
|
|
|
|
|
|
||||
Total depreciation and amortization expense |
|
$ |
|
|
$ |
|
$ |
|
|
$ |
|
||||
17
8. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consist of the following (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
Marketing reimbursement |
|
$ |
|
|
$ |
|
||
Accrued compensation |
|
|
|
|
|
|
||
Accrued selling and marketing |
|
|
|
|
|
|
||
Accrued professional fees |
|
|
|
|
|
|
||
Accrued restructuring |
|
|
|
|
|
|
||
Other accrued expenses |
|
|
|
|
|
|
||
Total accrued expenses and other current liabilities |
|
$ |
|
|
$ |
|
||
In November 2024, the Company's management approved and initiated plans to reduce its cost structure. The Company recorded ($
Accrual at December 31, 2023 |
|
$ |
|
|
Restructuring charges and related costs |
|
|
|
|
Cash payments |
|
|
( |
) |
Accrual at December 31, 2024 |
|
|
|
|
Restructuring charges and related costs |
|
|
( |
) |
Cash payments |
|
|
( |
) |
Accrual at June 30, 2025 |
|
$ |
|
9. Debt
The components of the Company’s third-party debt consist of the following (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
RTW Convertible Notes |
|
$ |
|
|
$ |
|
||
Total principal amount of debt |
|
|
|
|
|
|
||
Change in fair value |
|
|
( |
) |
|
|
( |
) |
Long-term debt, net of current portion and discounts |
|
$ |
|
|
$ |
|
||
Fortress Term Loan
On August 1, 2023, the Company entered into the Fortress Term Loan pursuant to the Fortress Credit Agreement with Fortress that provided gross proceeds of $
On December 29, 2023, the Company entered into an amendment to the Fortress Credit Agreement (the "Fortress Amendment"). The Fortress Amendment waived the December 31, 2023 minimum revenue covenant under the Fortress Credit Agreement and modified the minimum liquidity covenant by increasing the minimum liquidity amount from $
18
2024 and $
The Company assessed the terms and features of the Fortress Credit Agreement in order to identify any potential embedded features that would require bifurcation or any beneficial conversion features. The terms and features assessed included, under certain circumstances, a default interest rate of
On April 16, 2024, the Company repaid all outstanding obligations under the Fortress Term Loan with proceeds from the Amended Note Purchase Agreement (as defined below) with RTW. The total payoff amount was $
Interest expense for the three months ended June 30, 2024 related to the Fortress Term Loan was $
Convertible Notes
2023 Convertible Notes
Between February and August 2023, the Company entered into a convertible note purchase agreement, and related side letters, for the sale of convertible notes (the "2023 Convertible Notes") to certain investors for gross proceeds of $
Additionally, the 2023 Convertible Notes provided that, effective upon the closing of a qualified financing, holders of the 2023 Convertible Notes could optionally accelerate repayment of the principal and interest of the 2023 Convertible Notes or convert all of the outstanding principal and interest into shares of Legacy Allurion common stock or shares of the same class or series of capital stock issued in the qualified financing equal to the balance of the 2023 Convertible Notes on the date of conversion divided by the greater of the capped price or the discounted price. The capped price is calculated by dividing $
On May 2, 2023 the Company entered into termination agreements (the “Termination Agreements”) with respect to side letters entered into with certain holders of the 2023 Convertible Notes. With respect to the Termination Agreement with HVL, the Company
19
had the right to prepay, in one or more transactions, all or a portion of the outstanding principal amount, plus accrued interest, under such holder's 2023 Convertible Note (the “HVL Bridge Note”), including by way of (a) a $
In addition, under the Termination Agreement executed with HVL, the Company agreed to issue to HVL a number of shares of Allurion Common Stock (“PubCo Additional Shares”) equal to (a) the outstanding principal and accrued interest under the HVL Bridge Note immediately prior to the consummation of the transactions contemplated by the Business Combination Agreement (after giving effect to the payment of the repayments) divided by $
Further on May 2, 2023, the Backstop Purchasers entered into the Backstop Agreement with the Company, Legacy Allurion and HVL. Pursuant to the Backstop Agreement, each Backstop Purchaser agreed that to the extent any HVL Bridge Notes remained outstanding prior to the consummation of the Business Combination, such Backstop Purchaser would, at the closing of the Business Combination, purchase up to $
On August 1, 2023, immediately prior to the closing of the Business Combination, the Company repaid $
RTW Convertible Notes
On April 14, 2024, the Company entered into a note purchase agreement (the "Original Note Purchase Agreement") with RTW as agent for the purchasers (the "Purchasers") party thereto from time to time (RTW in such capacity, the "Principal Purchaser"), and Acquiom Agency Services LLC ("Acquiom") as collateral agent for the Purchasers. Subsequently, on April 16, 2024, the Company, the Principal Purchaser, the Purchasers, and Acquiom entered into the First Amendment to the Original Note Purchase Agreement (the Original Note Purchase Agreement as amended, the "Amended Note Purchase Agreement").
Pursuant to the Amended Note Purchase Agreement, the Company issued and sold $
20
approximately $
On January 7, 2025, the Company and Allurion Technologies, LLC ("Allurion OpCo") entered into an Omnibus Amendment (the “Omnibus Amendment”) with Allurion Australia Pty Ltd, Allurion France, and RTW to amend the Amended Note Purchase Agreement, the Revenue Interest Financing Agreement, and the New RIFA (collectively, the "Existing Documents").
The Omnibus Amendment requires, among other things, (i) the Company and Allurion OpCo to maintain certain minimum balances of unrestricted cash in controlled accounts in the U.S. in the amounts corresponding to the calculations set forth therein, and (ii) the Company to receive minimum trailing 12-month consolidated Revenue (as defined in the Amended Note Purchase Agreement) in amounts set forth therein, tested quarterly beginning with the 12-month period ending September 30, 2025. The Omnibus Amendment also requires that (i) Allurion France shall have successfully regained marketing authorization from the Agence Nationale de Sécurité du Médicament (“ANSM”) in France on or prior to December 31, 2025 and (ii) Allurion OpCo shall have received Marketing Authorization from the U.S. Food & Drug Administration for the Commercialization of the Product in the United States no later than June 30, 2026.
Pursuant to the Omnibus Amendment, the investors and the purchasers party thereto will receive a number of shares of the Company’s Common Stock, representing in the aggregate
On April 15, 2025, the Company, the Principal Purchaser, and the Purchasers entered into a Second Amendment to the Note Purchase Agreement (the "Second Amendment to Note Purchase Agreement"), which amended the Existing Note Purchase Agreement to reflect additional conversions and other provisions. The Second Amendment to Note Purchase Agreement provides for the mandatory conversion of $
In addition, without regard to the Market Capitalization Condition, the Purchasers may provide the Company notice to convert up to an additional $
21
The Second Amendment to Note Purchase Agreement is accounted for as an extinguishment of debt under ASC 470, due to the substantive conversion features included in the Second Amendment to Note Purchase Agreement. The fair value of the RTW Convertible Notes were remeasured immediately before and after the Amendment was signed on April 15, 2025 as $
The RTW Convertible Notes were accounted for under the FVO election of ASC 825 at inception in April 2024 as the notes contain embedded derivatives, including the conversion upon Stockholder Approval, the conversion upon a Fundamental Change Company Notice (as defined in the RTW Convertible Notes), the conversion upon a Make-Whole Fundamental Change (as defined in the RTW Convertible Notes), redemption upon the event of default, and redemption upon a Fundamental Change (as defined in the RTW Convertible Notes), which would require bifurcation and separate accounting. The RTW Convertible Notes will continue to be accounted for under the FVO election following the extinguishment of debt in connection with the Second Amendment to Note Purchase Agreement. Prior to the Amendment, the RTW Convertible Notes were initially measured at their issue-date estimated fair value and subsequently remeasured at estimated fair value on a recurring basis at each reporting period date. The fair value of the RTW Convertible Notes at issuance in April 2024 was $
The Share Obligation is accounted for as a liability under ASC 480, Distinguishing Liabilities from Equity ("ASC 480"). As the Share Obligation was initiated in exchange for amendments of the Amended Note Purchase Agreement, the Revenue Interest Financing Agreement, and the New RIFA, all of which are accounted for under the FVO election, the liability was recorded at its initial fair value of $
For the three months ended June 30, 2025, the Company recorded a $
The Company elected paid in kind interest for the three and six months ended June 30, 2025 related to the RTW Convertible Notes.
10. Revenue Interest Financing, Side Letter, and PIPE Conversion Option
On February 9, 2023, Legacy Allurion entered into the Revenue Interest Financing Agreement. Pursuant to the Revenue Interest Financing, at the closing of the Business Combination, RTW paid Allurion an aggregate of $
If RTW has not received aggregate revenue interest payments equal to at least
The Revenue Interest Financing is accounted for under the FVO election of ASC 825 as the Revenue Interest Financing contains embedded derivatives, including the requirements to settle the Revenue Interest Financing prior to maturity upon the occurrence of certain contingent events and our ability to prepay the Revenue Interest Financing, which would require bifurcation and separate
22
accounting. The Revenue Interest Financing was initially measured at its issue-date estimated fair value and subsequently remeasured at estimated fair value on a recurring basis at each reporting period date. Changes in fair value are recorded as a component of Other income (expense) in the condensed consolidated statements of operations. A portion of the estimated change in fair value must be reported in other comprehensive loss to the extent that it is attributable to instrument-specific credit risk. In connection with the issuance of the Investment Amount, we paid $
Concurrently, and in connection with the Amended Note Purchase Agreement, the Revenue Interest Financing Agreement was amended pursuant to an Omnibus Amendment (the "RIFA Amendment") by and among the Company, Allurion Opco, Allurion Australia Pty Ltd, a proprietary limited company organized under the laws of Australia and a wholly-owned subsidiary of the Company, the Original RIFA Investors (as defined therein) and RTW, on April 14, 2024. The RIFA Amendment, among other things, increased the rate of revenue interest payments to be paid to RTW on all current and future products, digital solutions and services developed, imported, manufactured, marketed, offered for sale, promoted, sold, tested or otherwise distributed by Allurion and its subsidiaries for net sales less than or equal to $
The RIFA Amendment was accounted for as a modification with the change in fair value of the PIPE Conversion Option treated as an exchange between the Company and RTW as part of the RIFA Amendment. As such, the Revenue Interest Financing and PIPE Conversion Option were remeasured as of April 16, 2024 just prior to the RIFA Amendment, to $
In connection with the Company entering into the Revenue Interest Financing, if, at any time beginning 12 months and ending 24 months following the closing of the Mergers, the VWAP per share of Allurion Common Stock is less than $1
On October 22, 2024, funds affiliated with RTW provided notice to the Company of their election of the PIPE Conversion Option under the Amended and Restated RTW Side Letter to surrender
The exercise of the PIPE Conversion Option was accounted for as a settlement of the derivative liability. As such, the PIPE Conversion Option was remeasured as of October 30, 2024 just prior to conversion, to $
For the three months ended June 30, 2025, the Company recorded a $
23
operations and other comprehensive income (loss), respectively. The changes in fair value were recorded in the Changes in fair value of Revenue Interest Financing and PIPE Conversion Option in the condensed consolidated statement of operations.
11. Fair Value Measurements
The following tables present the fair value hierarchy for the Company's assets and liabilities that are measured at fair value at issuance date and on a recurring basis and indicate the level within the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value (in thousands):
Fair Value Measurement as of June 30, 2025 |
|
|||||||||||||||
|
|
Total Carrying |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
Total assets |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Legacy Allurion Common Stock Warrant Liabilities |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Public Warrants |
|
|
|
|
$ |
|
|
|
— |
|
|
|
— |
|
||
Public Offering Warrants |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
July 2024 Private Placement Warrants |
|
|
|
|
|
— |
|
|
|
— |
|
|
$ |
|
||
January 2025 Warrants |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
February 2025 Offering Warrants |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Revenue Interest Financing |
|
|
|
|
|
— |
|
|
|
— |
|
|
$ |
|
||
Earn-out Liability |
|
|
|
|
|
— |
|
|
|
— |
|
|
$ |
|
||
RTW Convertible Notes |
|
|
|
|
|
— |
|
|
|
— |
|
|
$ |
|
||
Success Fee Derivative Liability |
|
|
|
|
|
— |
|
|
|
— |
|
|
$ |
|
||
Share Obligation |
|
|
|
|
|
— |
|
|
|
— |
|
|
$ |
|
||
Total Liabilities |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
Fair Value Measurement as of December 31, 2024 |
|
|||||||||||||||
|
|
Total Carrying |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
Total assets |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Legacy Allurion Common Stock Warrant Liabilities |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Public Warrants |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Public Offering Warrants |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
July 2024 Private Placement Warrants |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Revenue Interest Financing |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Earn-out Liability |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
RTW Convertible Notes |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Success Fee Derivative Liability |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Total Liabilities |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
Public Warrants
As a result of the Business Combination on August 1, 2023, the Company recorded a liability for Public Warrants to purchase the Company's Common Stock. The Public Warrants are traded on the NYSE and are recorded at fair value using the closing price as June 30, 2025 of $
Legacy Allurion Warrants, Public Offering Warrants, July 2024 Private Placement Warrants, January 2025 Warrants, and February 2025 Offering Warrants
24
The Company has classified the Legacy Allurion Common Stock Warrants, Public Offering Warrants (defined below), July 2024 Private Placement Warrants (defined below), January 2025 Warrants (defined below), and February 2025 Offering Warrants (defined below) within Level 3 of the hierarchy as the fair value is derived using the Black-Scholes option pricing model, which uses a combination of observable (Level 2) and unobservable (Level 3) inputs. See table below for the assumptions used in the pricing model of the Legacy Allurion Common Stock Warrants, Public Offering Warrants, July 2024 Private Placement Warrants, January 2025 Warrants, and February 2025 Offering Warrants:
|
|
Measurement |
|
Interest |
|
|
Exercise |
|
|
Estimated Fair Value of Underlying Share Price |
|
|
Expected |
|
|
Expected |
|
|||||
Legacy Allurion Series C Preferred Stock |
|
June 30, 2025 |
|
|
% |
|
$ |
|
|
$ |
|
|
|
% |
|
|
|
|||||
Legacy Allurion Other Common Stock |
|
June 30, 2025 |
|
|
% |
|
|
|
|
|
|
|
|
% |
|
|
|
|||||
Legacy Allurion Series D-1 Preferred Stock |
|
June 30, 2025 |
|
|
|
|
|
|
|
|
|
|
% |
|
|
|||||||
Public Offering Warrants |
|
June 30, 2025 |
|
|
% |
|
|
|
|
|
|
|
% |
|
|
|
||||||
July 2024 Private Placement Warrants |
|
June 30, 2025 |
|
|
% |
|
|
|
|
|
|
|
|
% |
|
|
|
|||||
January 2025 Warrants |
|
June 30, 2025 |
|
|
% |
|
|
|
|
|
|
|
|
% |
|
|
|
|||||
February 2025 Offering Warrants |
|
June 30, 2025 |
|
|
% |
|
|
|
|
|
|
|
|
% |
|
|
|
|||||
|
|
Measurement |
|
Interest |
|
|
Exercise |
|
|
Estimated Fair Value of Underlying Share Price |
|
|
Expected |
|
|
Expected |
|
|||||
Legacy Allurion Series C Preferred Stock warrants (as converted to Common) |
|
December 31, 2024 |
|
|
% |
|
$ |
|
|
$ |
|
|
|
% |
|
|
|
|||||
Legacy Allurion Other Common Stock |
|
December 31, 2024 |
|
|
% |
|
|
|
|
|
|
|
|
% |
|
|
|
|||||
Legacy Allurion Series D-1 Preferred Stock |
|
December 31, 2024 |
|
|
|
|
|
|
|
|
|
|
% |
|
|
|||||||
Public Offering Warrants |
|
December 31, 2024 |
|
|
% |
|
|
|
|
|
|
|
|
% |
|
|
|
|||||
July 2024 Private Placement Warrants |
|
December 31, 2024 |
|
|
% |
|
|
|
|
|
|
|
|
% |
|
|
|
|||||
Expected dividend yield for all calculations is
The following table reconciles the changes in fair value for the three and six months ended June 30, 2025 and 2024 of the warrant liabilities valued using Level 3 inputs:
25
|
|
Preferred Stock Warrants (as converted to Common) |
|
|
Common Stock Warrants |
|
|
Public Offering Warrants |
|
|
July 2024 Private Placement Warrants |
|
|
January 2025 Warrants |
|
|
February 2025 Warrants |
|
|
Total |
|
|||||||
Balance – March 31, 2024 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|||
Change in fair value |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Balance – June 30, 2024 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|||
Balance – March 31, 2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Change in fair value |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Balance – June 30, 2025 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|||||||
|
|
Preferred Stock Warrants (as converted to Common) |
|
|
Common Stock Warrants |
|
|
Public Offering Warrants |
|
|
July 2024 Private Placement Warrants |
|
|
January 2025 Warrants |
|
|
February 2025 Warrants |
|
|
Total |
|
|||||||
Balance – January 1, 2024 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|||
Change in fair value |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Balance – June 30, 2024 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|||
Balance – January 1, 2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Fair value at issuance |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|||
Change in fair value |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Balance – June 30, 2025 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|||||||
2019 Term Loan Success Fee Derivative Liability
The derivative liability for the success fee associated with Legacy Allurion's November 2019 loan and security agreement with Western Alliance Bank (the "2019 Term Loan" and such fee, the "Success Fee") was recorded at fair value as of June 30, 2025 and December 31, 2024 using the following assumptions: weighted-average probability for the likelihood of a change in control or liquidity event within
Revenue Interest Financing and PIPE Conversion Option
The Revenue Interest Financing is accounted for using the FVO election. Under the FVO election, the financial instrument is initially measured at its issue-date estimated fair value and subsequently remeasured at estimated fair value on a recurring basis at each reporting period date. The fair value of the Revenue Interest Financing was remeasured as of June 30, 2025 and December 31, 2024 using a discounted cash flow ("DCF") method under the income approach utilizing future revenue projections and a discount rate of
The fair value of the PIPE Conversion Option was accounted for as a derivative under ASC 815. Upon the exercise of the PIPE Conversion Option and resulting New RIFA on October 30, 2024, the PIPE Conversion Option was reclassified as an addition to the Revenue Interest Financing liability, and as such there is no PIPE Conversion Option liability as of June 30, 2025 and December 31, 2024.
Earn-Out Liability
Upon the closing of the Business Combination, the Earn-Out Shares were accounted for as a liability because the triggering events that determine the number of shares to be earned included events that were not indexed to Allurion Common Stock, with the change in fair value recognized in Change in the fair value of earn-out liabilities in the consolidated statement of operations.
26
|
|
June 30, |
|
|
December 31, |
|
||
Stock Price |
|
$ |
|
|
$ |
|
||
Risk-free interest rate |
|
|
% |
|
|
% |
||
Expected term (in years) |
|
|
|
|
|
|
||
Expected volatility |
|
|
% |
|
|
% |
||
Term Loan Derivative Liability
The term loan derivative liability associated with the Fortress Term Loan was derecognized upon repayment of the Fortress Term Loan on April 16, 2024.
RTW Convertible Notes
The RTW Convertible Notes are accounted for using the FVO election. Under the FVO election, the financial instrument is initially measured at its issue-date estimated fair value and subsequently measured at estimated fair value on a recurring basis at each reporting period date. The fair value of the RTW Convertible Notes was remeasured as of June 30, 2025 using a DCF method under the income approach with a MCSM applied to determine the simulated stock price at each payment date and event that may trigger conversion of the RTW Convertible Notes.
|
|
June 30, |
|
|
December 31, |
|
||
Stock Price |
|
$ |
|
|
$ |
|
||
Risk-free interest rate |
|
|
% |
|
|
% |
||
Expected term (in years) |
|
|
|
|
|
|
||
Expected volatility |
|
|
% |
|
|
% |
||
Share Obligation
The Share Obligation is accounted for as a liability under ASC 480, with the liability initially measured at its issue-date estimate fair value and subsequently measured at its estimated fair value on a recurring basis at each reporting period date.
|
|
June 30, |
|
|
Risk-free interest rate |
|
|
% |
|
Expected term (in years) |
|
|
|
|
Expected volatility |
|
|
% |
|
Expected market yield |
|
|
% |
|
27
The changes in the fair values of the Success Fee derivative liability, Revenue Interest Financing, PIPE Conversion Option, Earn-out liability, Term Loan Derivative liability, RTW Convertible Notes, PubCo Share liability, and Share Obligation categorized with Level 3 inputs for the three and six months ended June 30, 2025 and 2024 were as follows:
|
|
Success Fee Derivative Liability |
|
|
Revenue Interest |
|
|
PIPE Conversion Derivative |
|
|
Earn-Out |
|
|
Term Loan Derivative Liability |
|
|
RTW Convertible Notes |
|
|
Share Obligation |
|
|
Total |
|
||||||||
Balance – March 31, 2024 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||||||
Fair value upon issuance |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Change in fair value (Restated) (1) |
|
|
— |
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
Change in fair value - OCI (Restated) (1) |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Repayments of debt |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Balance – June 30, 2024 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
||||||
Balance – March 31, 2025 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
Fair value upon issuance |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Change in fair value |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|||
Change in fair value - OCI |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Conversion of convertible notes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Repayments of debt |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Balance – June 30, 2025 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
|
|
Success Fee Derivative Liability |
|
|
Revenue Interest |
|
|
PIPE Conversion Derivative |
|
|
Earn-Out |
|
|
Term Loan Derivative Liability |
|
|
RTW Convertible Notes |
|
|
Share Obligation |
|
|
Total |
|
||||||||
Balance – January 1, 2024 (Restated) (1) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||||||
Fair value upon issuance |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Change in fair value (Restated) (1) |
|
|
— |
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
Change in fair value - OCI (Restated) (1) |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Repayments of debt |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Balance – June 30, 2024 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
||||||
Balance – January 1, 2025 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||||
Fair value upon issuance |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Change in fair value (Restated) (1) |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
|
|
|
( |
) |
|
|
|
|||
Change in fair value - OCI (Restated) (1) |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Conversion of convertible notes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Repayments of debt |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Balance – June 30, 2025 |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
(1) As discussed in FN 2, Restatement of Previously Issued Financial Statements, the Company identified an Error in its historical financial statements related to the change in fair value due to instrument specific credit risk for the Revenue Interest Financing and RTW Convertible Notes, as well as a change in fair value of the PIPE Conversion Option. The only restated numbers in the table above relate to the 'Change in fair value' and 'Change in fair value - OCI' for both the Revenue Interest Financing and RTW Convertible Notes, as well as the 'Change in fair value' related to the PIPE Conversion Option.
28
12. Income Taxes
The Company recorded income tax expense for each of the three and six months ended June 30, 2025 of less than $
On July 4, 2025, new U.S tax legislation was signed into law (known as the "One Big Beautiful Bill Act" or "OBBBA") which makes permanent many of the tax provisions enacted in 2017 as part of the Tax Cuts and Jobs Act that were set to expire at the end of 2025. The Company is currently evaluating the impact of the new legislation but does not expect it to have a material impact on the results of operations.
As of June 30, 2025 and 2024, the Company maintained a full valuation allowance against its net deferred tax assets as the Company has incurred significant operating losses since inception and has concluded that its net deferred tax asset is not more-likely-than-not realizable.
As of June 30, 2025 and 2024, the Company has
13. Capital Stock and Stockholders' Deficit
Preferred Equity
On June 28, 2024, the Company entered into a subscription agreement (the "Subscription Agreement") with RTW, pursuant to which the Company agreed to sell
The July 2024 Private Placement Warrants met the definition of a derivative under ASC 815. The gross proceeds from the July 2024 Private Placement were first allocated to the July 2024 Private Placement Warrants based on their issue-date estimated fair value of $
On December 19, 2024, following the Series A Stockholder Approval (as defined below) and after giving effect to the Reverse Stock Split, the
The Charter authorizes the issuance of up to
Voting Rights
The Series A Preferred Stockholders have
Dividend Rights
The Series A Preferred Stock participates in dividends with Common Stock on an as-converted basis when declared by the Board.
Liquidation Preference
29
Common Stock would receive if such holder’s Series A Convertible Preferred Stock were fully converted to Common Stock plus an additional amount equal to any dividends declared but unpaid to such share.
Conversion Rights
Redemption
Common Equity
Allurion's Charter authorizes the issuance of up to
July 2024 Public Offering
On June 28, 2024, the Company entered into an underwriting agreement with Jefferies LLC and TD Securities (USA) LLC, as representative of the several underwriters (the "Underwriters"), pursuant to which the Company agreed to issue and sell
The Public Offering Warrants met the definition of a derivative under ASC 815 and the Share Overallotment met the requirements for equity classification under ASC 815. The $
RTW Private Placement
On January 14, 2025, the Company entered into a subscription agreement (the “RTW Subscription Agreement”) with funds affiliated with RTW, pursuant to which the Company agreed to sell
January 2025 Public Offering and Concurrent Private Placement
On January 24, 2025, the Company entered into a securities purchase agreement (the “January 2025 Securities Purchase Agreement”) with certain accredited investors named therein, pursuant to which the Company agreed to issue and sell
30
Certain purchasers in the January 2025 Offering and January 2025 Private Placement are holders of warrants to purchase Common Stock issued in the Public Offering in July 2024. The exercise price for the Public Offering Warrants initially was $
The January 2025 Warrants met the definition of a derivative under ASC 815. The $
February 2025 Public Offering and Concurrent Private Placement and Leavitt Private Placement
On February 19, 2025, the Company entered into a securities purchase agreement (the “February 2025 Securities Purchase Agreement”) with certain accredited investors named therein, pursuant to which the Company agreed to issue and sell
Additionally, on February 19, 2025, the Company entered into a subscription agreement (the “Leavitt Subscription Agreement”) with an accredited investor affiliated with Leavitt Equity Partners LLC (collectively, “Leavitt”), pursuant to which the Company agreed to issue and sell
The February 2025 Offering Warrants met the definition of a derivative under ASC 815. The $
The number of shares of Common Stock that have been reserved for issuance upon the potential conversion or exercise, as applicable, of the Company’s securities as of June 30, 2025, is as follows:
Outstanding options to purchase Common Stock |
|
|
|
|
Restricted Stock Units |
|
|
|
|
Warrants to purchase Common Stock |
|
|
|
|
Shares of Common Stock issued upon the exercise of Public Warrants |
|
|
|
|
Earn-Out Shares |
|
|
|
|
Convertible Notes |
|
|
|
|
Total |
|
|
|
31
Warrants to Purchase Common Stock
In connection with the closing of the Business Combination, all outstanding warrants to purchase Legacy Allurion preferred stock and Legacy Allurion common stock were converted into Rollover Warrants to purchase Allurion Common Stock using the Exchange Ratio.
In connection with the Public Offering and July 2024 Private Placement, we issued the Public Offering Warrants and July 2024 Private Placement Warrants. As of June 30, 2025, there were
June 30, 2025 |
|
|||||||||||||||
Issuance Date |
|
Remaining |
|
|
Underlying Equity Instrument |
|
Balance Sheet |
|
Shares Issuable |
|
|
Weighted |
|
|||
3/30/2021 |
|
|
|
|
Common Stock |
|
Liability |
|
|
|
|
$ |
|
|||
9/15/2022 |
|
|
|
|
Common Stock |
|
Liability |
|
|
|
|
|
|
|||
6/4/2022 |
|
|
|
|
Common Stock |
|
Liability |
|
|
|
|
|
|
|||
1/17/2017 |
|
|
|
|
Common Stock |
|
Equity |
|
|
|
|
|
|
|||
8/3/2017 |
|
|
|
|
Common Stock |
|
Equity |
|
|
|
|
|
|
|||
9/8/2017 |
|
|
|
|
Common Stock |
|
Liability |
|
|
|
|
|
|
|||
6/19/2018 |
|
|
|
|
Common Stock |
|
Liability |
|
|
|
|
|
|
|||
6/25/2019 |
|
|
|
|
Common Stock |
|
Liability |
|
|
|
|
|
|
|||
7/1/2024 |
|
|
|
|
Common Stock |
|
Liability |
|
|
|
|
|
|
|||
1/27/2025 |
|
|
|
|
Common Stock |
|
Liability |
|
|
|
|
|
|
|||
2/20/2025 |
|
|
|
|
Common Stock |
|
Liability |
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
December 31, 2024 |
|
|||||||||||||||
Issuance Date |
|
Remaining |
|
|
Underlying Equity Instrument |
|
Balance Sheet |
|
Shares Issuable |
|
|
Weighted |
|
|||
12/1/2014 |
|
|
- |
|
|
Common Stock |
|
Equity |
|
|
|
|
$ |
|
||
3/30/2021 |
|
|
|
|
Common Stock |
|
Liability |
|
|
|
|
|
|
|||
9/15/2022 |
|
|
|
|
Common Stock |
|
Liability |
|
|
|
|
|
|
|||
6/4/2022 |
|
|
|
|
Common Stock |
|
Liability |
|
|
|
|
|
|
|||
1/17/2017 |
|
|
|
|
Common Stock |
|
Equity |
|
|
|
|
|
|
|||
8/3/2017 |
|
|
|
|
Common Stock |
|
Equity |
|
|
|
|
|
|
|||
9/8/2017 |
|
|
|
|
Common Stock |
|
Liability |
|
|
|
|
|
|
|||
6/19/2018 |
|
|
|
|
Common Stock |
|
Liability |
|
|
|
|
|
|
|||
6/25/2019 |
|
|
|
|
Common Stock |
|
Liability |
|
|
|
|
|
|
|||
7/1/2024 |
|
|
|
|
Common Stock |
|
Liability |
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
In Compute Health's initial public offering, it sold units at a price of $
32
Warrants will expire August 1, 2030, seven years after the completion of the Business Combination, or earlier upon redemption or liquidation.
The Company may redeem the outstanding Public Warrants for cash at a price of $
The Company may redeem the outstanding Public Warrants for shares of our Common Stock at a price of $
Chardan Equity Facility
On December 18, 2023, we entered into a ChEF Purchase Agreement (the "Purchase Agreement") and a Registration Rights Agreement, each with Chardan Capital Markets ("Chardan") related to a "ChEF," Chardan's committed equity facility (the "Chardan Equity Facility"). Pursuant to the Purchase Agreement, the Company has the right from time to time at its option to sell to Chardan up to the lesser of (i) $
14. Net Income (Loss) per Share
Basic and diluted net income (loss) per share was calculated as follows:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
|
|
|
|
|
(Restated) |
|
|
|
|
|
(Restated) |
|
||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted weighted-average common stock outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
For the three and six months ended June 30, 2025, the Company’s potentially dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number of shares of Common Stock outstanding used to calculate both basic and diluted net loss per share attributable to stockholders is the same.
33
period end, from the computation of diluted net loss per share attributable to stockholders for the periods indicated because including them would have had an anti-dilutive effect:
|
|
As of June 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Outstanding options to purchase Common Stock |
|
|
|
|
|
|
||
Restricted Stock Units |
|
|
|
|
|
|
||
Warrants to purchase Common Stock |
|
|
|
|
|
|
||
Shares of Common Stock issued upon the exercise of Public Warrants |
|
|
|
|
|
|
||
Earn-Out Shares |
|
|
|
|
|
|
||
Convertible Notes |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
15. Stock Based Compensation
Stock Incentive Plans
The Company’s 2010 Stock Incentive Plan (the “2010 Plan”) provided for the grant of qualified incentive stock options, nonqualified stock options, and other awards to the Company’s employees, officers, directors, advisors, and outside consultants to purchase the Company’s Common Stock. On December 11, 2020, the Board adopted the Amended and Restated 2020 Stock Option and Grant Plan (the “2020 Plan”), which provided for the grant of qualified incentive stock options, nonqualified stock options, and other awards to the Company’s employees, officers, directors, advisors, and outside consultants to purchase the Company’s Common Stock. Each stock option from the 2010 Plan and the 2020 Plan that was outstanding immediately prior to the Business Combination, whether vested or unvested, was cancelled and exchanged for a stock option to purchase Allurion Common Stock based on the Exchange Ratio. The per share exercise price for each stock option was divided by the Exchange Ratio.
In connection with the closing of the Business Combination, the Company adopted the 2023 Stock Option and Incentive Plan (the "2023 Plan"), which provides for the award of stock options (both incentive and non-qualified), stock appreciation rights, restricted stock units ("RSUs"), restricted stock awards, cash-based awards, and dividend equivalent rights. As of June 30, 2025, a total of
As of June 30, 2025,
Stock-based compensation expense included in the condensed consolidated statement of operations was as follows:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Cost of revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Selling, general and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Stock Options
The following table summarizes the option activity under the 2010 Plan, 2020 Plan, and the 2023 Plan during the six months ended June 30, 2025:
|
|
Number of |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
34
|
|
|
|
|
(per option) |
|
|
(in years) |
|
|
(in thousands) |
|
||||
Outstanding—January 1, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cancellations and forfeitures |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Outstanding—June 30, 2025 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Exercisable at June 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Total stock compensation expense related to stock option awards during the three and six months ended June 30, 2025 was $
The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model and the assumptions noted in the table below. Expected volatility for the Company’s Common Stock was determined based on an average of the historical volatility of a peer group of public companies that are similar to the Company. The expected term of options granted to employees was calculated using the simplified method, which represents the average of the contractual term of the option and the weighted-average vesting period of the option. The Company uses the simplified method because it does not have sufficient historical option exercise data to provide a reasonable basis upon which to estimate expected term. The expected term of options granted to non-employees is the remaining contractual term of the award. The assumed dividend yield is based upon the Company’s expectation of not paying dividends in the foreseeable future. The risk-free rate for periods within the expected life of the option is based upon the U.S. Treasury yield curve in effect at the time of grant.
There were
|
|
Six Months Ended |
|
|
|
|
2024 |
|
|
Expected volatility |
|
|
% |
|
Risk-free interest rate |
|
|
% |
|
Expected dividend yield |
|
|
% |
|
Expected term (in years) |
|
|
|
|
Restricted Stock Units
In December 2022, the Company issued RSUs to a member of the Board with vesting subject to both a performance-based closing condition dependent on the successful Business Combination with Compute Health and time-based vesting conditions. See Note 4, Business Combination for information about the closing of the Business Combination with Compute Health. Upon the satisfaction of the closing condition,
35
compensation expense related to employee PSUs for the six months ended June 30, 2025.
|
|
Number of RSUs |
|
|
Weighted |
|
||
|
|
|
|
|
(per share) |
|
||
Outstanding—January 1, 2025 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Cancellations and forfeitures |
|
|
( |
) |
|
|
|
|
Vested |
|
|
( |
) |
|
|
|
|
Outstanding—June 30, 2025 |
|
|
|
|
$ |
|
||
Total stock compensation expense related to RSUs for the three and six months ended June 30, 2025 was $
Employee Stock Purchase Plan
In connection with the closing of the Business Combination, the Company adopted the 2023 Employee Stock Purchase Plan (the "2023 ESPP"). Under the 2023 ESPP, substantially all employees may voluntarily enroll to purchase the Company's Common Stock through payroll deductions at a price equal to
A total of
16. Employee Benefit Plan
The Company has a 401(k) retirement plan that covers eligible U.S. employees. Eligible employees may elect to contribute up to the maximum limits, as set by the Internal Revenue Service, of their eligible compensation. The Company may elect to make a discretionary contribution or match a discretionary percentage of employee contributions. During the three and six months ended June 30, 2025 and 2024, the Company's matching contributions to the plan were less than $
17. Commitments and Contingencies
Leases
With respect to contracts involving the use of assets, if the Company has the right to direct the use of the asset and obtain substantially all economic benefits from the use of an asset, it accounts for the service contract as a lease.
As of June 30, 2025, the Company was a party to four different leases for office, manufacturing, and laboratory space under non-cancelable office leases in two cities. These leases total approximately
36
The components of right-of-use ("ROU") assets and lease liabilities are included in the condensed consolidated balance sheets. The short-term portion of the Company's operating lease liability is recorded as part of Accrued expenses and other current liabilities on the condensed consolidated balance sheets.
Aggregate Lease Information
Other pertinent lease information for the three and six months ended June 30, 2025 and 2024 is as follows (in thousands):
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2025 |
|
|
2024 |
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2025 |
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2024 |
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Operating lease costs |
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$ |
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$ |
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$ |
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$ |
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Short-term lease costs |
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Variable lease costs |
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Operating cash flows paid for amounts in the |
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Operating lease assets obtained in exchange |
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Future commitments under non-cancelable operating lease agreements as of June 30, 2025 are as follows (in thousands):
2025 |
$ |
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2026 |
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2027 |
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2028 |
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Total lease payments |
$ |
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Less: present value adjustment |
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( |
) |
Total lease liabilities |
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Less: current lease liability |
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( |
) |
Long-term operating lease liabilities |
$ |
|
The weighted-average remaining lease terms and discount rates related to our leases were as follows:
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June 30, |
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June 30, |
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Weighted -average remaining lease term (in years) |
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Weighted-average discount rate |
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% |
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% |
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Product Liability
The Company has not received any material product liability claims but nevertheless has obtained and maintains insurance related to potential product liability claims.
Litigation and Claims
In the normal course of operations, the Company may become involved in various claims and legal proceedings related to, for example, the validity or scope of its intellectual property rights, employee-related matters, securities class actions, or adverse patient reactions. Additionally, during the normal course of business, the Company may be a party to legal claims that may not be covered by insurance.
On August 12, 2025, Vanderbilt University Medical Center (“Vanderbilt”) filed a complaint against the Company in the United States District Court for the Middle District of Tennessee, captioned Vanderbilt University Medical Center v. Allurion Technologies, Inc., d/b/a Allurion. Vanderbilt's complaint alleges that the Company breached the Clinical Trial Agreement, dated June 30, 2022, by and between the Company and Vanderbilt, related to the clinical trial for the Allurion Balloon by failing to reimburse medical expenses incurred in treating a patient enrolled in such trial at Vanderbilt. Vanderbilt is seeking damages of approximately $
As of June 30, 2025 and December 31, 2024, the Company has recorded accruals for the contractual obligations under the Clinical Trial Agreement with Vanderbilt.
French Regulatory Decision
37
On August 6, 2024, it was announced that the ANSM, the French regulatory authority, had suspended sales of the Allurion Balloon in France, and the Company withdrew the device from the French market. The Company implemented a remediation plan to reduce certain risks associated with advertising, follow-up program, and adverse events for the Allurion Balloon. For the year ended December 31, 2024, the Company recognized a reduction to revenues of $
NYSE Continued Listing Standards
On August 29, 2024, the Company received written notice from the NYSE notifying the Company that as of August 29, 2024, Allurion was not in compliance with the continued listing standard set forth in Section 802.01B of the NYSE's Listed Company Manual (the "Minimum Market Capitalization Standard") because our average market capitalization was less than $
18. Segment Information
Segment reporting is prepared on the same basis that the Company's chief executive officer, who is our chief operating decision maker (“CODM”), manages the business, makes operating decisions, and assesses performance. The Company operates in
Disclosures about significant segment expenses and long-lived assets by geography are presented below. Refer to Note 5, Revenue for information on revenue by geography.
Significant segment expenses are set forth in the following table (in thousands):
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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(Restated) |
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(Restated) |
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Revenue |
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$ |
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$ |
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$ |
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$ |
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Less: |
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Cost of revenue |
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Sales and marketing |
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Clinical trials and medical affairs |
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Product development |
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Digital |
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Quality and regulatory |
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General and administrative |
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Other segment items (1) |
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( |
) |
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( |
) |
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( |
) |
|
Net loss |
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$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
(1) Other segment items included in Net income primarily include changes in fair value of warrant liabilities, changes in fair value of debt, changes in fair value of the Revenue Interest Financing, loss on extinguishment of debt, interest expense, and other income.
Long-lived assets, consisting of property and equipment, net and ROU assets by geography were as follows (in thousands):
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June 30, |
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December 31, |
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United States |
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$ |
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$ |
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France |
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Long-lived assets |
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$ |
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$ |
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38
19. Related-party Transactions
Lease Agreement with Related Party
In August 2022, the Company entered into an operating lease agreement for additional office space in Paris, France with LNMP JPBC Invest. The Company’s then-Trade Marketing Director was the signor of this lease for LNMP JPBS Invest. Additionally, the Company’s former Chief Commercial Officer is also a partner of LNMP JPBC Invest. The lease agreement included lease payments of approximately $
Convertible Note Agreement with RTW
Pursuant to the Amended Note Purchase Agreement, on April 16, 2024, we issued and sold $
RTW Participation in Public Offering
In connection with the Public Offering, the Company issued and sold
Private Placement with RTW
On June 28, 2024, pursuant to the Subscription Agreement, the Company agreed to sell to RTW
Exercise of PIPE Conversion Option and New RIFA with RTW
On October 22, 2024, funds affiliated with RTW provided notice to the Company of their election of the PIPE Conversion Option under the Amended and Restated RTW Side Letter, to surrender
January 2025 Private Placement with RTW
On January 14, 2025, the Company entered into the RTW Subscription Agreement with funds affiliated with RTW, pursuant to which the Company agreed to sell
Second Amendment to Amended Note Purchase Agreement
On April 15, 2025, the Company, the Purchasers and RTW, as agent for the Purchasers entered into the Second Amendment to Note Purchase Agreement, which amended the Amended Note Purchase Agreement to reflect additional conversion and other provisions, including provisions permitting the conversion of the RTW Convertible Notes at reduced conversion prices, resulting in the potential issuance of additional shares, which had been approved by the Company’s stockholders at the Special Meeting of Stockholders held on April 10, 2025. On April 16, 2025, subject to the terms of the Second Amendment to Note Purchase Agreement, the Purchasers provided notice of conversion of $
39
20. Subsequent Events
On August 5, 2025, the Company announced a strategic restructuring plan (the “Restructuring Plan”), pursuant to which, the Company intends to focus on low-dose GLP-1 combination therapy, muscle mass maintenance, and U.S. market entry, in combination with other cost-saving measures. The Restructuring Plan includes a reduction in force of approximately
40
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis includes information that our management believes is relevant to an assessment and understanding of our condensed consolidated results of operations and financial condition. The discussion and analysis should be read together with the unaudited consolidated financial statements as of and for the three and six months ended June 30, 2025 and June 30, 2024 included in this Quarterly Report on Form 10-Q, and the audited consolidated financial statements as of and for the years ended December 31, 2024 that are included in our Annual Report on Form 10-K filed with the SEC on March 27, 2025, as amended by Amendment No. 1 to the Annual Report on Form 10-K filed with the SEC on August 19, 2025 (together, the "Annual Report on Form 10-K"). This discussion may contain forward-looking statements that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in the sections titled “Cautionary Statement Regarding Forward-Looking Statements” and “Risk Factors” in our Annual Report on Form 10-K and this Quarterly Report on Form 10-Q. For purposes of this section, all references in this discussion and analysis to “Allurion,” the “Company”, “we,” “us,” or “our” refers to the business and operations of Allurion Technologies, Inc. and its consolidated subsidiaries following the consummation of the Business Combination and to Legacy Allurion and its consolidated subsidiaries prior to the consummation of the Business Combination. “Legacy Allurion” refers to Allurion Technologies, LLC, which was previously known as Allurion Technologies Opco, Inc. (formerly Allurion Technologies, Inc.) prior to the consummation of the Business Combination.
Restatement of Previously Issued Financial Statements
As discussed in the Explanatory Note to this Form 10-Q, the Company is restating its previously issued unaudited condensed consolidated financial statements as of and for the three and six months ended June 30, 2024. As a result, the previously reported financial information as of and for the three and six months ended June 30, 2024 in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” has been amended and restated to reflect the restatement. See the section entitled “Restatement of Previously Issued Financial Statements” in Note 2 “Restatement of Previously Issued Financial Statements” to the unaudited consolidated financial statements included in this Form 10-Q for further detail regarding the restatement, including descriptions of the adjustments and the impacts on our unaudited consolidated financial statements.
Other than the effect of the restatement noted above, the information as of and for the three and six months ended June 30, 2024 included in this section has not been otherwise modified and does not reflect any information or events occurring after August 14, 2024, the filing date of the Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, or modify or update those disclosures affected by events that occurred at a later date or facts that subsequently became known to the Company, except to the extent they are otherwise required to be included and discussed herein.
Overview
Allurion is a leading medical device company that is focused on creating a best-in-class weight loss platform to treat obese and overweight patients. Our platform, the Allurion Program (the "Allurion Program"), features the world’s first and only swallowable, procedureless™ intragastric balloon for weight loss (the "Allurion Balloon") and offers artificial intelligence ("AI")-powered remote patient monitoring tools, a proprietary behavior change program, secure messaging and video telehealth that are delivered by the Allurion Virtual Care Suite ("VCS").
The Allurion Program was designed to achieve metabolically healthy weight loss, which entails losing weight, maintaining that weight loss, and maintaining or increasing muscle mass in the process. Unlike other options that lead to short-term weight loss and muscle wasting, the Allurion Program is intended to deliver longer lasting results while reducing fat and not muscle. We believe the Allurion Program is also synergistic in combination with other weight loss therapies, including glucagon-like peptide 1 ("GLP-1") receptor agonists.
Our proprietary intragastric balloon, the Allurion Balloon, is swallowed as a capsule under the guidance of a health care provider without surgery, endoscopy, or anesthesia for placement.
The Allurion VCS is comprised of tools to support patients’ weight loss experience, which we believe benefit both patients and health care providers:
41
In addition to its use by Allurion Balloon patients, we believe the VCS can potentially be a platform for optimal long-term follow up after other medical and surgical weight loss interventions in the future. We have incorporated a Treatment Tracking and Clinic-Led Onboarding feature into the VCS that enables seamless onboarding and management of patients undergoing one or multiple weight loss treatments, including gastric balloons such as the Allurion Balloon, surgery, or medication, and in April 2024, launched the VCS in the United States for patients utilizing other weight loss treatments, including anti-obesity medications and bariatric surgery.
Our Allurion Program products are currently sold in Europe, the Middle East, Africa, Latin America, Canada and the Asia-Pacific region.
Since our inception, we have incurred significant operating losses. Our ability to generate revenue and achieve cost improvements sufficient to achieve profitability will depend on the successful further development and commercialization of our products and receipt and maintenance of regulatory approvals. We generated revenue of $9.0 million and $21.2 million for the six months ended June 30, 2025 and 2024, respectively, and incurred losses from operations of $14.2 million and $20.7 million for those same periods, respectively. We expect to continue to incur net losses for the foreseeable future as we focus on obtaining regulatory approvals for our products in new markets, refining our sales and marketing strategies, and continuing research and development efforts to further enhance our existing products. Further, following the closing of the Business Combination, we have incurred, and expect to continue to incur, additional costs associated with operating as a public company. As a result, we will need additional funding for expenses related to our operating activities, including selling, marketing, general and administrative, and research and development expenses.
Because of the numerous risks and uncertainties associated with obtaining and maintaining regulatory approval, market acceptance of our products, product development and enhancement, and commercialization, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. Until such time, if ever, as we can generate substantial revenue sufficient to achieve profitability, we expect to finance our operations through a combination of equity offerings and debt financings. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we are unable to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the further development and commercialization efforts of one or more of our products, or may be forced to reduce or terminate our operations. See the subsections entitled — “Liquidity and Capital Resources” and “Recent Developments” below.
Recent Developments
Reverse Stock Split
On January 3, 2025, our 1-for-25 reverse stock split (the "Reverse Stock Split") was effective following approval by stockholders at the Company's 2024 annual meeting in December 2024. As a result, every 25 shares of our issued Common Stock were combined into one share of our Common Stock. No fractional shares of our Common Stock were issued as a result of the Reverse Stock Split. Stockholders who would otherwise have held a fraction of a share of Common Stock of the Company automatically received an additional fraction of a share of Common Stock to round up to the next whole share. The shares of our Common Stock retained a par value of $0.0001 per share. Trading of the Common Stock on the NYSE commenced on a split-adjusted basis at market open on January 3, 2025 under the existing trading symbol “ALUR.”
Omnibus Amendment
On January 7, 2025, we entered into an Omnibus Amendment (the “Omnibus Amendment”) by and among us, Allurion Technologies, LLC (“Allurion OpCo”), Allurion Australia Pty Ltd, Allurion France, and RTW Investments, LP (together with its affiliates, “RTW”) and certain of its affiliates, to amend (i) the Note Purchase Agreement, dated as of April 14, 2024 (as amended, the “Amended Note Purchase Agreement”), by and among us, RTW and Acquiom Agency Services LLC, the Revenue Interest Financing Agreement, dated as of February 9, 2023 (as amended, the “Revenue Interest Financing Agreement”), by and among us and RTW (such financing, the “Revenue Interest Financing”) and the additional Revenue Interest Financing Agreement, dated as of October 30, 2024 (as amended, the “New RIFA”), by and among us and RTW (collectively, the “Existing Documents”).
The Omnibus Amendment requires (i) us and Allurion OpCo to maintain certain minimum balances of unrestricted cash in controlled accounts in the United States in the amounts corresponding to the calculations set forth therein, and (ii) us to receive minimum trailing 12-month consolidated Revenue (as defined in the Existing Documents) at amounts designated in the Omnibus Amendment, tested quarterly beginning with the 12-month period ending September 30, 2025. The Omnibus Amendment also requires that (i) Allurion France shall have successfully regained marketing authorization from the Agence Nationale de Sécurité du Médicament (“ANSM”) to resume the Commercialization (as defined in the Existing Documents) of the Product (as defined in the
42
Existing Documents) in France on or prior to December 31, 2025, which occurred in February 2025 as discussed further below, and (ii) Allurion OpCo shall have received marketing authorization from the U.S. Food and Drug Administration (the “FDA”) for the commercialization of the Product in the United States no later than June 30, 2026.
Pursuant to the Omnibus Amendment, the purchasers shall receive a number of shares of the Common Stock, representing five percent of our fully-diluted shares outstanding (without regard to any beneficial ownership limitations) immediately after the closing of the offering and sale of Additional Shares (as defined in the Existing Documents) to be consummated no later than February 15, 2025, in connection with which we raised at least $12.0 million in aggregate net proceeds; provided that, in the event we cannot issue shares of Common Stock to the purchasers thereunder due to applicable law, we shall instead issue an equivalent (as-converted) number of shares of a newly created series of Series A-1 non-voting preferred stock, par value $0.0001 per share (the “Series A-1 Preferred Stock”), and will include a proposal in a definitive proxy statement on Schedule 14A seeking stockholder approval no later than December 31, 2025 to allow the conversion of Series A-1 Preferred Stock into Common Stock; provided further that, each share of Series A-1 Preferred Stock outstanding on December 31, 2026 shall, except to the extent prohibited by Delaware law governing distributions to stockholders (including the Delaware General Corporation Law), be redeemed by us for cash in an amount equal to the as-converted value of the underlying Common Stock.
The Omnibus Amendment also provides that we will ensure RTW shall have the right to designate one director to the Board, which director is currently Nicholas Lewin, and as of the Amendment Effective Date (as defined in the Omnibus Amendment), RTW has the right to designate a second director to the Board, which additional director is initially R. Jason Richey.
Topline AUDACITY FDA Pivotal Trial Results
On January 8, 2025, we announced topline results from our AUDACITY pivotal trial evaluating the safety and efficacy of the Allurion Balloon. The AUDACITY trial was an open-label, multicenter, randomized, controlled trial and was the first FDA pivotal trial on an intragastric balloon for weight loss to report primary outcomes beyond nine months. The AUDACITY trial achieved its responder rate co-primary endpoint by demonstrating that more than 50% of Allurion Balloon subjects lost more than 5% of their total body weight at 48 weeks (58%; p-value = 0.0089). At 48 weeks, Allurion Balloon subjects exhibited substantially greater weight loss compared to control subjects with a 3.77% mean difference in total body weight loss, resulting in a 2.69% superiority margin. This margin was less than the pre-specified 3% superiority margin needed to meet the comparative co-primary endpoint (p-value=0.1616). At 40 weeks, the 4.22% mean difference in total body weight loss between groups exceeded a 3% superiority margin.
The rate of serious adverse events in Allurion Balloon subjects in the AUDACITY trial was 3.1%, the lowest reported in a pivotal FDA trial for a liquid-filled intragastric balloon indicated for weight loss.
Based on the results of the AUDACITY trial, the fourth and final module of the premarket approval application ("PMA") was submitted to the FDA.
January 2025 RTW Private Placement
On January 14, 2025, we entered into a subscription agreement (the “January 2025 Subscription Agreement”) with funds affiliated with RTW, pursuant to which we agreed to issue and sell 841,751 shares of Common Stock for an aggregate purchase price of approximately $2.5 million at a purchase price of $2.97 per share (the “January 2025 RTW Private Placement”). The January 2025 RTW Private Placement closed on January 16, 2025.
January 2025 Public Offering and Concurrent Private Placement
On January 24, 2025, we entered into a securities purchase agreement (the “January 2025 Securities Purchase Agreement”) with certain accredited investors named therein, pursuant to which we agreed to issue and sell 1,240,000 shares of Common Stock (the “January 2025 Offering”) and 1,240,000 accompanying common warrants (the “January 2025 Warrants”) to purchase up to 1,240,000 shares of Common Stock upon exercise of the January 2025 Warrants in a concurrent private placement (the “January 2025 Private Placement”), at an offering price of $6.00 per share and accompanying January 2025 Warrant. The January 2025 Offering and January 2025 Private Placement closed on January 27, 2025 with net proceeds of approximately $5.8 million, after deducting the placement agent fees and estimated offering expenses payable by the Company.
February 2025 Public Offering and Concurrent Private Placement
On February 19, 2025, we entered into a securities purchase agreement (the “February 2025 Securities Purchase Agreement”) with certain accredited investors named therein, pursuant to which we agreed to issue and sell 900,000 shares of Common Stock (the “February 2025 Offering”), and 1,800,000 accompanying common warrants (the “February 2025 Warrants”) to purchase up to 1,800,000 shares of Common Stock upon exercise of the February 2025 Warrants in a concurrent private placement (the “February 2025 Private Placement”), at an offering price of $5.23 per share and accompanying February 2025 Warrant. The February 2025 Offering and February 2025 Private Placement closed on February 20, 2025, and resulted in net proceeds of approximately $3.9 million, after deducting the placement agent fees and estimated offering expenses payable by the Company.
Leavitt Private Placement
43
On February 19, 2025, we entered into a subscription agreement (the “Leavitt Subscription Agreement”) with an accredited investor affiliated with Leavitt Equity Partners LLC (collectively, “Leavitt”), pursuant to which we agreed to issue and sell 267,686 shares of Common Stock (the “Private Placement Shares”) and common warrants to purchase up to 535,372 shares of Common Stock (the “Leavitt Private Placement Warrants” and together with the February 2025 Warrants, the “February 2025 Offering Warrants”), at a purchase price of $5.23 per share and accompanying Leavitt Private Placement Warrant (the “Leavitt Private Placement”). The Leavitt Private Placement closed on February 20, 2025 with net proceeds of $1.3 million after deducting placement agent fees of $0.1 million.
Resumption of Sales in France
On February 13, 2025, we announced that we were relaunching the Allurion Balloon in France after the ANSM, the French regulatory authority, repealed its temporary suspension of sales of the device following our completion of the remediation plan we developed in cooperation with the agency and we were cleared to resume sales of the Allurion Balloon, effective immediately.
Second Amendment to Note Purchase Agreement
On April 15, 2025, we entered into the Second Amendment to Note Purchase Agreement (the “Second Amendment to Note Purchase Agreement") with the purchasers of the RTW Convertible Notes (the "Purchasers") and RTW, as agent for the purchasers, which amended the Amended Note Purchase Agreement to reflect additional conversion and other provisions, including provisions permitting the conversion of a portion of the RTW Convertible Notes at reduced conversion prices, resulting in the potential issuance of additional shares, which was approved by our stockholders at the Special Meeting of Stockholders held on April 10, 2025.
The Second Amendment to Note Purchase Agreement provides for the mandatory conversion of $5.0 million of principal amount of the RTW Convertible Notes in the event our market capitalization, as determined in accordance with the rules of the NYSE or such other nationally recognized securities exchange upon which the Common Stock is then listed, is reasonably expected to fall below $15.0 million (the “Market Capitalization Condition”). In the event such Market Capitalization Condition is triggered, the Purchasers shall provide notice to the Company, and the Company shall accept such notice, to convert $5.0 million aggregate principal amount of the RTW Convertible Notes at the Floor Conversion Rate (defined below), and such amount shall be converted into 1,492,539 shares of our Common Stock.
On April 16, 2025, the Purchasers provided notice of conversion of $5.0 million of principal amount of the RTW Convertible Notes based on the closing price of the Common Stock on the immediately preceding trading day and resulting market capitalization of less than $15.0 million. The parties that it is reasonably expected that such market capitalization will remain below $15.0 million for the period of time that would result in delisting under NYSE rules and, accordingly, that the Market Capitalization Condition had been triggered and such mandatory conversion of $5.0 million of principal amount of the RTW Convertible Notes shall occur at the floor price of $3.35 per share. The Company subsequently issued an aggregate of 1,492,539 shares of Common Stock (subject to rounding for fractional shares) in accordance with the terms of the Second Amendment to Note Purchase Agreement.
In the event such Market Capitalization Condition is triggered, the Purchasers also have the right to provide us notice to convert up to an additional $5.0 million of aggregate principal amount of the RTW Convertible Notes into shares of Common Stock at an agreed conversion rate. We have the right to accept or reject such conversion in our sole discretion. The parties will mutually agree on the agreed conversion rate, provided that it is not more than 298.5075 shares of Common Stock per $1,000 principal amount of the RTW Convertible Notes, reflecting a floor conversion price of $3.35 per share of Common Stock (such rate, the “Floor Conversion Rate”).
In addition, without regard to the Market Capitalization Condition, the Purchasers may provide us notice to convert up to an additional $5.0 million aggregate principal amount of the RTW Convertible Notes into shares of Common Stock at the 5-Day VWAP Conversion Rate, which we may accept or reject in our sole discretion. The "5 Day VWAP Conversion Rate” is the lesser of (i) the quotient of $1,000 divided by the daily volume weighted average price of the Common Stock for the five consecutive trading day period ending on the trading day immediately preceding the date of the delivery of the notice, discounted by five percent and (ii) the Floor Conversion Rate.
Finally, during the one year period ending on April 15, 2026, the Purchasers in their sole discretion may provide us notice to convert up to an additional $1.0 million aggregate principal amount of the RTW Convertible Notes in any 30-day period into shares of Common Stock at the 5-Day VWAP Conversion Rate. If the Purchasers do not exercise their right to provide a notice to convert all or a portion of $1.0 million aggregate principal amount of the RTW Convertible Notes per month, any shortfall may be included in the amount to be converted in a subsequent 30-day period. The maximum principal amount of the RTW Convertible Notes that may be converted under such monthly conversion provision is $12.0 million. We may accept or reject any such monthly conversion in our sole discretion.
The Second Amendment to Note Purchase Agreement also contains an agreement by the Purchasers that, without our prior written consent, until the Voting Agreement Termination Date (defined below), at any meeting of our stockholders, including any postponement, recess or adjournment thereof, or in any other circumstance in which a vote, consent or other approval of stockholders
44
is sought, the Purchasers will either, at their sole option (i) abstain from voting the shares of Common Stock issued pursuant to the new conversion provisions set forth in the Second Amendment to Note Purchase Agreement described above, or (ii) vote such shares in proportion to the votes cast on the applicable matter with respect to the shares of Common Stock beneficially owned by persons other than the Purchasers or any of their affiliates. Such voting agreement shall terminate upon the earlier of (i) the effective date of any Fundamental Change or Make-Whole Fundamental Change (as such terms are defined in the Amended Note Purchase Agreement) and (ii) the date on which the Purchasers and their affiliates collectively have the power to vote shares of Common Stock (including the shares issued upon conversion pursuant to the Second Amendment to Note Purchase Agreement) representing less than 9.9% of the voting power of the outstanding shares of the Company (such date, the “Voting Agreement Termination Date”).
Submission of Fourth and Final Module of Pre-Market Approval Application
On July 7, 2025, we announced that we submitted to the FDA the fourth and final module of our pre-market approval (“PMA”) application, which included additional supportive analyses from our AUDACITY trial that meet both of the pre-specified co-primary endpoints. Topline results announced previously showed that the AUDACITY trial met its first co-primary endpoint related to responder rate at 48 weeks. Allurion Balloon subjects also exhibited substantially greater weight loss compared to control subjects at 48 weeks, with a mean difference in total body weight loss of 3.77%, resulting in a 2.69% super-superiority margin. This margin was less than the pre-specified 3% super-superiority margin needed to meet the comparative co-primary endpoint and was impacted, in part, by higher-than-expected weight loss in control subjects.
Additional analyses submitted in our PMA application were conducted to account for the results seen in the control group. Using imputation methods that account for the variations observed in the control subjects, the mean difference in weight loss between the treatment and control groups at 48 weeks was 4.34% with a super-superiority margin of 3.14%, exceeding the pre-specified 3% super-superiority margin in the second co-primary endpoint (p = .0142).
At 40 weeks, using these imputation methods, the mean difference in weight loss between the treatment and control groups was 4.90% with a super-superiority margin of 3.75%, considerably exceeding the pre-specified margin in the second co-primary endpoint (p = .0006).
Strategic Restructuring and Reduction in Force
On August 5, 2025, we announced a strategic restructuring plan (the “Restructuring Plan”), pursuant to which we intend to focus on low-dose GLP-1 combination therapy, muscle mass maintenance, and U.S. market entry, in combination with other cost-saving measures. We launched several R&D, clinical and commercial initiatives in the second quarter of 2025 in light of this shift, including the below:
The Restructuring Plan includes a reduction in force of approximately 70 employees, or approximately 65% of its workforce, which we expect to substantially complete by the end of the third quarter of 2025. As part of this Restructuring Plan, we expect to incur severance and severance-related charges of approximately $1.5 million. Our estimated restructuring charges is based on a number of assumptions. Actual results may differ materially and we may also incur other charges or cash expenditures not currently contemplated or that cannot be currently estimated due to events that may occur as a result of, or be associated with, the Restructuring Plan.
Key Factors Affecting Our Operating Results
We believe that our performance and future success depend on many factors that present significant opportunities but also pose risks and challenges, including those discussed below and in the “Risk Factors” section of our Annual Report on Form 10-K.
45
Operating Segments
We operate our business in a single segment and as one reporting unit, which is how our chief operating decision maker ("CODM"), our chief executive officer, reviews financial performance and allocates resources. The CODM reviews financial information presented on a regular basis at the consolidated level for purposes of allocating resources and evaluating financial performance. Since we operate as one operating segment, all required financial segment information can be found in the consolidated financial statements.
Components of Our Results of Operations
Revenue
We derive revenue from the sale of the Allurion Balloon to customers, which are either distributors or health care providers. The Allurion Balloon is the foundation of the Allurion Program, a holistic weight loss program that offers patients the opportunity to receive, and clinic and other health care providers the ability to deliver, behavior change assistance through their use of our remote patient support and monitoring tools.
Cost of Revenue
Cost of revenue consists primarily of costs that are closely correlated or directly related to the delivery of our products, including material costs, labor costs, and depreciation expense for fixed assets.
Operating Expenses
Sales and Marketing Expenses
Sales and marketing expenses consist primarily of salaries and related expenses (including commissions) for our sales and marketing personnel. Marketing programs consist of advertising, training events, brand building, product marketing activities and shipping costs.
Research and Development Expenses
Our research and development expenses consist of costs associated with performing research and development activities such as registering our products in various jurisdictions and performing clinical trials. These costs include salaries and benefits, stock-based compensation, non-capitalizable software development costs, product development costs, materials and supplies, clinical trial activities, registration expenses, depreciation of equipment and other outside services.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and personnel-related costs, including stock-based compensation, for our personnel in executive, information technology, finance and accounting, human resources and other administrative functions. General and administrative expenses also include legal fees relating to corporate matters; professional fees paid for accounting, auditing, consulting and tax services; insurance costs; travel expenses; office and information technology costs; and facilities, depreciation and other expenses related to general and administrative activities, which include direct or allocated expenses for rent and maintenance of facilities and utilities.
Other Income (Expense), Net
46
Interest Expense
Interest expense consists of interest expense associated with outstanding borrowings under our debt obligations as well as the amortization of debt issuance costs and discounts associated with such borrowings.
Change in Fair Value of Warrants
The change in fair value of warrants consists of the expense recognized upon the mark to market of our warrant liabilities.
Change in Fair Value of Debt
The change in fair value of debt consists of the expense recognized upon the mark to market of our convertible debt.
Change in Fair Value of Revenue Interest Financing and PIPE Conversion Option
The change in fair value of Revenue Interest Financing and PIPE Conversion Option consists of the expense recognized upon the mark to market of the Revenue Interest Financing with RTW and the issuance and mark to market of the PIPE Conversion Option. See Note 11, Fair Value Measurements for further information.
Change in Fair Value of Earn-out Liabilities
The change in fair value of earn-out liabilities consists of the gain or loss recognized upon mark to market of the contingent earn-out consideration. See Note 11, Fair Value Measurements for further information.
Loss on extinguishment of debt
The loss on extinguishment of debt consists of the loss recognized upon the termination of our Fortress Term Loan and RTW Convertible Notes.
Other Income (Expense), net
Other income (expense), net consists of interest earned on our invested cash balances, which primarily consist of deposit accounts and money market funds, foreign currency transaction gains and losses and expense associated with our Share Obligation liability (as defined in Note 9, Debt, in the accompanying notes to the condensed consolidated financial statements). See Note 11, Fair Value Measurements, for further information.
Results of Operations
47
Comparison of the Three and Six Months Ended June 30, 2025 and 2024 (unaudited)
The following table summarizes our results of operations for the three and six months ended June 30, 2025 and 2024 (in thousands):
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||||||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|
2025 |
|
|
2024 |
|
|
Change |
|
||||||
|
|
|
|
|
(Restated) |
|
|
|
|
|
|
|
|
(Restated) |
|
|
|
|
||||||
Revenue |
|
$ |
3,379 |
|
|
$ |
11,766 |
|
|
$ |
(8,387 |
) |
|
$ |
8,959 |
|
|
$ |
21,152 |
|
|
$ |
(12,193 |
) |
Cost of revenue |
|
|
882 |
|
|
|
2,773 |
|
|
|
(1,891 |
) |
|
|
2,301 |
|
|
|
5,293 |
|
|
|
(2,992 |
) |
Gross profit |
|
|
2,497 |
|
|
|
8,993 |
|
|
|
(6,496 |
) |
|
|
6,658 |
|
|
|
15,859 |
|
|
|
(9,201 |
) |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Sales and marketing |
|
|
2,412 |
|
|
|
6,718 |
|
|
|
(4,306 |
) |
|
|
6,033 |
|
|
|
12,863 |
|
|
|
(6,830 |
) |
Research and development |
|
|
1,800 |
|
|
|
4,310 |
|
|
|
(2,510 |
) |
|
|
4,424 |
|
|
|
10,035 |
|
|
|
(5,611 |
) |
General and administrative |
|
|
5,237 |
|
|
|
7,311 |
|
|
|
(2,074 |
) |
|
|
10,435 |
|
|
|
13,697 |
|
|
|
(3,262 |
) |
Total operating expenses: |
|
|
9,449 |
|
|
|
18,339 |
|
|
|
(8,890 |
) |
|
|
20,892 |
|
|
|
36,595 |
|
|
|
(15,703 |
) |
Loss from operations |
|
|
(6,952 |
) |
|
|
(9,346 |
) |
|
|
2,394 |
|
|
|
(14,234 |
) |
|
|
(20,736 |
) |
|
|
6,502 |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Interest expense |
|
|
- |
|
|
|
(339 |
) |
|
|
339 |
|
|
|
- |
|
|
|
(2,270 |
) |
|
|
2,270 |
|
Changes in fair value of warrants |
|
|
2,064 |
|
|
|
1,376 |
|
|
|
688 |
|
|
|
7,733 |
|
|
|
4,507 |
|
|
|
3,226 |
|
Change in fair value of debt |
|
|
(4,530 |
) |
|
|
8,070 |
|
|
|
(12,600 |
) |
|
|
(1,200 |
) |
|
|
8,070 |
|
|
|
(9,270 |
) |
Changes in fair value of Revenue Interest Financing and PIPE conversion option |
|
|
60 |
|
|
|
(5,994 |
) |
|
|
6,054 |
|
|
|
(3,760 |
) |
|
|
(8,094 |
) |
|
|
4,334 |
|
Changes in fair value of earn-out liabilities |
|
|
105 |
|
|
|
5,690 |
|
|
|
(5,585 |
) |
|
|
1,015 |
|
|
|
19,880 |
|
|
|
(18,865 |
) |
Loss on extinguishment of debt |
|
|
(660 |
) |
|
|
(8,713 |
) |
|
|
8,053 |
|
|
|
(660 |
) |
|
|
(8,713 |
) |
|
|
8,053 |
|
Other income (expense), net |
|
|
621 |
|
|
|
999 |
|
|
|
(378 |
) |
|
|
408 |
|
|
|
1,171 |
|
|
|
(763 |
) |
Total other income: |
|
|
(2,340 |
) |
|
|
1,089 |
|
|
|
(3,429 |
) |
|
|
3,536 |
|
|
|
14,551 |
|
|
|
(11,015 |
) |
Income (loss) before income taxes: |
|
|
(9,292 |
) |
|
|
(8,257 |
) |
|
|
(1,035 |
) |
|
|
(10,698 |
) |
|
|
(6,185 |
) |
|
|
(4,513 |
) |
Provision for income taxes: |
|
|
(43 |
) |
|
|
(65 |
) |
|
|
22 |
|
|
|
(138 |
) |
|
|
(141 |
) |
|
|
3 |
|
Net income (loss) |
|
$ |
(9,335 |
) |
|
$ |
(8,322 |
) |
|
$ |
(1,013 |
) |
|
$ |
(10,836 |
) |
|
$ |
(6,326 |
) |
|
$ |
(4,510 |
) |
Revenue
Revenue decreased $8.4 million, or 71%, to $3.4 million and decreased $12.2 million, or 58%, to $9.0 million for the three and six months ended June 30, 2025, respectively, compared to the same period in 2024. The decrease in revenue was primarily the result of the distributor transitions initiated in the second quarter of 2025, lower investment in sales and marketing as we move our strategy from business to business to customer and away from direct to customer, as well as the temporary suspension of sales in France. The decrease was also driven by selling less or no product to certain distributors and accounts to manage our credit risk.
Cost of Revenue
Cost of revenue decreased $1.9 million, or 68%, to $0.9 million for the three months ended June 30, 2025, and decreased $3.0 million, or 57%, to $2.3 million for the six months ended June 30, 2025 compared to the same periods in 2024. The decrease in cost of revenue was a direct result of decreased gastric balloon units sold.
Gross Profit
Gross profit decreased $6.5 million, or 72%, to $2.5 for the three months ended June 30, 2025, and decreased $9.2 million, or 58%, to $6.7 million for the six months ended June 30, 2025 compared to the same periods in 2024. The decrease in gross profit was primarily the result of a decrease in revenue and sales volume of our gastric balloon system.
Operating Expenses
Sales and Marketing Expenses
Sales and marketing expenses decreased $4.3 million, or 64%, to $2.4 million for the three months ended June 30, 2025, compared to the same period in 2024. The decrease in sales and marketing expenses was the result of a $2.2 million decrease in salaries and related benefit costs due to lower headcount as a result of a restructuring implemented during the fourth quarter of 2024, a $1.4 million decrease in marketing spend driven by a reorganization of our selling and marketing spend driven by a reorganization of our selling and marketing spend focusing on more efficient channels and geographies, and a $0.6 million decrease in shipping and logistics expenses.
48
Sales and marketing expenses decreased $6.8 million, or 53%, to $6.0 million for the six months ended June 30, 2025, as compared to the same period in 2024. The decrease in sales and marketing expenses was the result of a $3.8 million decrease in salaries and related benefit costs due to lower headcount as a result of a restructuring implemented during the fourth quarter of 2024, a $2.5 million decrease in marketing spend driven by a reorganization of our selling and marketing spend focusing on more efficient channels and geographies, and a $0.3 million decrease in shipping and logistics expenses.
Research and Development Expenses
Research and development expenses decreased $2.5 million, or 58%, to $1.8 million for the three months ended June 30, 2025, compared to the same period in 2024. The decrease in research and development expenses was primarily the result of a $1.6 million decrease in costs related to the AUDACITY clinical trial as the fourth and final module of the PMA was submitted to the FDA and a $0.8 million decrease attributable to salaries and related benefit costs due to lower headcount as a result of the restructuring implemented during the fourth quarter of 2024.
Research and development expenses decreased $5.6 million, or 56%, to $4.4 million for the six months ended June 30, 2025, compared to the same period in 2024. The decrease in research and development expenses was primarily the result of a $3.0 million decrease in costs related to the AUDACITY clinical trial as the fourth and final module of the PMA was submitted to the FDA and a $1.6 million decrease attributable to salaries and related benefit costs due to lower headcount as a result of the restructuring implemented during the fourth quarter of 2024.
General and Administrative Expenses
General and administrative expenses decreased $2.1 million, or 28%, to $5.2 million for the three months ended June 30, 2025, compared to the same period in 2024. The decrease in general and administrative expenses was primarily the result of a $1.8 million decrease in legal and professional fees, inclusive of $1.4 million in one-time legal fees in connection with the Amended Note Purchase Agreement with RTW and a $1.3 million decrease attributable to salaries, benefits and related costs due to lower headcount as a result of the restructuring implemented during the fourth quarter of 2024. This decrease was partially offset by a $0.8 million increase in bad debt expense.
General and administrative expenses decreased $3.3 million, or 24%, to $10.4 million for the six months ended June 30, 2025, compared to the same period in 2024. The decrease in general and administrative expenses was primarily the result of a $2.8 million decrease attributable to salaries, benefits and related costs due to lower headcount as a result of the restructuring implemented during the fourth quarter of 2024 and a $1.4 million decrease in legal and professional fees, inclusive of $1.4 million in one-time legal fees in connection with the Amended Note Purchase Agreement with RTW. This decrease was partially offset by a $0.8 million increase in bad debt expense.
Other income (expense)
Interest Expense
Interest expense decreased $0.4 million, or 100%, to zero for the three months ended June 30, 2025 and $2.3 million, or 100%, to zero for the six months ended June 30, 2025, compared to the same periods in 2024. The decrease in interest expense was due the termination of our Fortress Term Loan in April 2024.
Change in Fair Value of Warrants
The $2.1 million and $7.7 million gains attributable to the change in fair value of warrants for the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024, were due to mark to market fluctuations in our warrant liabilities due to the decline in value of our Common Stock during the periods.
Change in Fair Value of Debt
The $4.5 million and $1.2 million losses (as restated) attributable to the change in fair value of debt for each of the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024, was due to mark to market fluctuations in our convertible debt.
Change in Fair Value of Revenue Interest Financing and PIPE Conversion Option
The $0.1 million gain and $3.8 million loss (as restated) attributable to the change in fair value of the Revenue Interest Financing and PIPE Conversion Option for the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024, was due to mark to market fluctuations in our Revenue Interest Financing during the period driven by an increase in the discount rate.
Change in Fair Value of Earn-Out Liabilities
49
The $0.1 million and $1.0 million gains attributable to the change in the fair value of earn-out liabilities for the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024, were due to the decline in value of our Common Stock during the periods.
Loss on extinguishment of debt
The $0.7 million loss on extinguishment of debt for both the three and six months ended June 30, 2025 was due to the loss on extinguishment of the RTW Convertible Notes in connection with the Second Amendment to Note Purchase Agreement. The $8.7 million loss attributable to the loss on extinguishment of debt for both the three and six months ended June 30, 2024 was due to the loss on extinguishment of our Fortress Term Loan in April 2024.
Other Income (Expense), Net
The change in Other income (expense), net for the three months ended June 30, 2025 compared to the same period in 2024 was a loss of $0.4 million. primarily driven by a $0.2 million decrease in other income. The change in Other income (expense), net for the six months ended June 30, 2025 compared to the same period in 2024, was a loss of $0.8 million driven by a $0.9 million loss related to the Share Obligation during the current six month period.
Provision for Income Taxes
We recorded a provision for income taxes of less than $0.1 million and $0.1 million for the three and six months ended June 30, 2025, respectively. These provisions for income taxes are due to net income in certain foreign jurisdictions.
Liquidity and Capital Resources
Since our inception, we have primarily obtained cash to fund our operations through the sale of Common Stock and preferred stock, issuance of term loans, and issuance of convertible debt instruments. As of June 30, 2025, we had $12.7 million in cash and cash equivalents. We incurred operating losses of $14.2 million and $20.7 million for the six months ended June 30, 2025 and 2024, respectively. We incurred cash outflows from operating activities of $17.1 million and $17.6 million during the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $233.0 million. We expect to continue to generate operating losses for the foreseeable future.
Our future capital requirements will depend on many factors, including:
Our revenue for the six months ended June 30, 2025 was $9.0 million, which represented a quarter-over-quarter decrease of 58%. The decrease in revenue was primarily the result of the distributor transitions initiated in the second quarter of 2025, lower investment in sales and marketing as we move our strategy from business to business to customer and away from direct to customer, as well as the temporary suspension of sales in France. The decrease was also driven by selling less or no product to certain distributors and accounts to manage our credit risk. If our current cash and anticipated revenue and resulting cash flows from operations are insufficient to satisfy our liquidity requirements, due to increased expenditures, lower demand for or sales of our gastric balloon system, the occurrence of other events or the realization of the risks described in our Annual Report on Form 10-K under the heading "Risk Factors," we may be required to raise additional capital through the issuances of public or private equity or debt financing or other capital sources earlier than expected.
Until such time as we can generate sufficient revenue to fund operations, we expect to use proceeds from the issuance of equity, debt financings, or other capital transactions to fund our operations and satisfy our liquidity requirements, but the amount and timing of such financings are uncertain. We may be unable to increase our revenue, raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to increase our revenue, raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue our operations or the development and commercialization of one or more of our product candidates and other strategic initiatives. Based on our recurring losses from operations incurred since inception, the expectation of continuing operating losses for the foreseeable future, and the need to raise additional capital to finance our future operations and debt service payments, we have concluded that there is substantial doubt about our ability to continue as a going concern for a period of one year from the date that the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q are issued.
Financing Arrangements
Leavitt Private Placement
On February 20, 2025, we received net proceeds of $1.3 million from the issuance of 267,686 shares of Common Stock and
50
535,372 Leavitt Private Placement Warrants at an offering price of $5.23 per share and accompanying warrant.
February 2025 Public Offering and Concurrent Private Placement
On February 20, 2025, we received net proceeds of $3.9 million from the issuance of 900,000 shares of Common Stock and 1,800,000 February 2025 Warrants at an offering price of $5.23 per share and accompanying warrant.
January 2025 Public Offering and Concurrent Private Placement
On January 27, 2025, we received net proceeds of $5.8 million from the issuance of 1,240,000 shares of Common Stock and 1,240,000 January 2025 Warrants at an offering price of $6.00 per share and accompanying warrant.
January 2025 RTW Private Placement
On January 16, 2025, we received net proceeds of $2.5 million from the issuance of 841,751 shares of Common Stock to funds affiliated with RTW as a purchase price of $2.97 per share.
Public Offering and Concurrent Private Placement
On July 1, 2024, we received $15.2 million in net proceeds from the issuance of 576,261 shares of Common Stock and 662,701 Public Offering Warrants and $2.5 million in net proceeds from the sale and issuance of 2,260,159 shares of Series A Preferred Stock (as converted to 90,407 shares of Common Stock following the Series A Stockholder Approval and Reverse Stock Split) and 90,407 July 2024 Private Placement Warrants in the July 2024 Private Placement, in each case at an offering price of $30.00 per share and accompanying warrant. On July 5, 2024, the underwriters in the public offering partially exercised their option to purchase an additional 77,091 shares of Common Stock for additional net proceeds of $2.2 million.
Note Purchase Agreement
On April 16, 2024, we received $48 million in gross proceeds from the Amended Note Purchase Agreement with RTW, which proceeds were used to repay all outstanding principal, accrued and unpaid interest and other obligations with respect to the Fortress Term Loan.
On April 15, 2025, we entered into the Second Amendment to Note Purchase Agreement with the Purchasers and RTW. On April 16, 2025, pursuant to the Second Amendment to Note Purchase Agreement, the Purchasers provided notice of conversion of $5.0 million of principal amount of the RTW Convertible Notes based on the closing price of the Common Stock on the immediately preceding trading day and resulting market capitalization of less than $15.0 million. The parties agreed that the Market Capitalization Condition was triggered and such mandatory conversion of $5.0 million of principal amount of the RTW Convertible Notes shall occur at the floor price of $3.35 per share. We subsequently issued an aggregate of 1,492,539 shares of Common Stock (subject to rounding for fractional shares) in accordance with the terms of the Second Amendment to Note Purchase Agreement.
As of June 30, 2025, $43.0 million of the RTW Convertible Notes remain outstanding and are included in convertible notes payable, net of discounts on our consolidated balance sheets. See Note 9, Debt, in the notes to our unaudited interim condensed consolidated financial statements for the three and six months ended June 30, 2025 and 2024 included within this Quarterly Report on Form 10-Q for additional details regarding the RTW Convertible Notes.
Chardan Purchase Agreement
On December 18, 2023, we entered into the Purchase Agreement with Chardan. Pursuant to the Purchase Agreement, we have the right from time to time at our option to sell to Chardan up to the lesser of (i) $100,000,000 in aggregate gross purchase price of newly issued shares of our Common Stock, and (ii) the Exchange Cap (379,299 shares of Common Stock), subject to certain conditions.
As of June 30, 2025, we have received $1.8 million in net proceeds from sales of shares of our Common Stock pursuant to the Purchase Agreement with Chardan.
Revenue Interest Financing Agreement
On August 1, 2023, we received $40.0 million in proceeds from the Revenue Interest Financing Agreement with RTW, which matures in December 2030. We entered into the Revenue Interest Financing Agreement on February 9, 2023 and received the proceeds at the closing of the Business Combination. On April 14, 2024, the Revenue Interest Financing Agreement was amended to, among other things, increase the rate of revenue interest payments to be paid to RTW. The Revenue Interest Financing Agreement is included in Revenue Interest Financing liability on our consolidated balance sheet as of June 30, 2025. See Note 10, Revenue Interest Financing, Side Letter, and PIPE Conversion Option in the notes to our unaudited interim condensed consolidated financial statements for the three and six months ended June 30, 2025 and 2024 included within this Quarterly Report on Form 10-Q for additional details regarding the Revenue Interest Financing Agreement.
On October 22, 2024, funds affiliated with RTW provided notice of their election under the Amended and Restated RTW Side Letter to surrender 30,000 shares of Common Stock representing $7.5 million in consideration for an additional Revenue Interest
51
Financing Agreement. Accordingly, on October 30, 2024, the Company and the funds affiliated with RTW entered into the New RIFA.
Material Cash Requirements for Known Contractual and Other Obligations
Leases
We have entered into various non-cancellable operating leases for our corporate office, manufacturing facilities, research and development labs, management office space and certain equipment. The leases have varying terms expiring between 2025 and 2028. See Note 17, Commitments and Contingencies of the notes to our unaudited interim condensed consolidated financial statements for the three and six months ended June 30, 2025 and 2024 for additional details related to our noncancelable operating leases.
RTW Convertible Notes
On April 16, 2024, we received $48 million in gross proceeds from the Amended Note Purchase Agreement with RTW, which proceeds were used to repay all outstanding principal, accrued and unpaid interest and other obligations with respect to the Fortress Term Loan.
On April 15, 2025, we entered into the Second Amendment to Note Purchase Agreement. On April 16, 2025, pursuant to the Second Amendment to Note Purchase Agreement, the Purchasers provided notice of conversion of $5.0 million of principal amount of the RTW Convertible Notes based on the closing price of the Common Stock on the immediately preceding trading day and resulting market capitalization of less than $15.0 million. The parties agreed that the Market Capitalization Condition was triggered and such mandatory conversion of $5.0 million of principal amount of the RTW Convertible Notes shall occur at the floor price of $3.35 per share. We subsequently issued an aggregate of 1,492,539 shares of Common Stock (subject to rounding for fractional shares) in accordance with the terms of the Second Amendment to Note Purchase Agreement.
Revenue Interest Financing
We received $40.0 million in proceeds from the Revenue Interest Financing Agreement with RTW on August 1, 2023. In exchange, we are obligated to remit to RTW certain revenue interest payments on all current and future products, digital solutions and services developed, imported, manufactured, marketed, offered for sale, promoted, sold, tested or otherwise distributed by Allurion and its subsidiaries at certain specified rates. On April 14, 2024, the Revenue Interest Financing Agreement was amended to, among other things, increase the rate of revenue interest payments to be paid to RTW for net sales less than or equal to $100 million prior to December 31, 2026 from 6% to 12%, and increase the royalty rate on net sales less than or equal to $100 million on or after January 1, 2027 from 10% to 12%.
If RTW has not received aggregate revenue interest payments equal to at least 100% of the Investment Amount by December 31, 2027, we must make a cash payment in an amount sufficient to catch RTW up to 100% of the Investment Amount. If RTW has not received revenue interest payments equal to at least 240% of the Investment Amount by December 31, 2030, we must make a cash payment in an amount sufficient to catch RTW up to 240% of the Investment Amount.
Further, on October 22, 2024, funds affiliated with RTW provided notice of their election under the Amended and Restated RTW Side Letter to surrender 30,000 shares of our Common Stock representing $7.5 million in consideration for an additional Revenue Interest Financing Agreement. Accordingly, on October 30, 2024, the Company and the funds affiliated with RTW entered into the New RIFA. The New RIFA has substantially identical terms and conditions as the Revenue Interest Financing Agreement, as amended by the Omnibus Amendment, except that the amount of financing provided under the New RIFA is equal to the conversion amount of $7.5 million.
Research and Development Costs
We are nearing the completion of our AUDACITY clinical trial in the United States and expect our expenses to decrease significantly as we continue to make payments related to the obligations with each clinical trial site. Our clinical trial costs are dependent on, among other things, the size, number, and length of our clinical trial.
Other Capital Requirements
We enter into agreements in the normal course of business with various vendors, which are generally cancelable upon notice. Payments due upon cancellation typically consist only of payments for services provided or expenses incurred, including non-cancelable obligations of service providers, up to the date of cancellation.
Cash Flows
52
The following table sets forth a summary of cash flows for the periods presented:
|
|
Six Months Ended June 30, |
|
|||||
(In thousands) |
|
2025 |
|
|
2024 |
|
||
Net cash used in operating activities |
|
$ |
(17,082 |
) |
|
$ |
(17,563 |
) |
Net cash used in investing activities |
|
|
- |
|
|
|
(539 |
) |
Net cash provided by (used in) financing activities |
|
|
14,428 |
|
|
|
(673 |
) |
Net decrease in cash and cash equivalents, and |
|
$ |
(2,654 |
) |
|
$ |
(18,775 |
) |
Net Cash Used in Operating Activities
Six Months Ended June 30, 2025
During the six months ended June 30, 2025, operating activities used $17.1 million of cash resulting from a net loss of $10.8 million (as restated) and net cash used from changes in our operating assets and liabilities of $7.0 million, partially offset by non-cash charges of $0.7 million (as restated).
Non-cash income consisted of $7.7 million of mark to market adjustments related to our warrant liabilities, $1.6 million of interest paid on debt recorded at fair value, $1.0 million of income related to the change in fair value of our earn-out liabilities, and $0.9 million other noncash items. This non-cash income was more than offset by a $3.8 million loss (as restated) related to the change in fair value of our Revenue Interest Financing and PIPE Conversion Option, $1.9 million of stock-based compensation expenses, $1.1 million of issuance costs related to warrants, a $1.2 million loss (as restated) related to the change in fair value of our convertible debt, $0.9 million change in the fair value of the Share Obligation, $0.7 million loss on the extinguishment of debt, $0.8 million provision for uncollectible accounts, $0.6 million of depreciation and amortization expense, $0.4 million provision for inventory, and $0.4 million of non-cash lease expense.
Net cash provided by changes in our operating assets and liabilities consisted of a $1.4 million decrease in accounts receivable, and a $0.2 million decrease in prepaid expenses, other current and long-term assets, partially offset by a net $7.1 million decrease in accounts payable, accrued expenses and other current liabilities, a $0.8 million increase in inventory, and a $0.5 million decrease in our lease liabilities.
The decrease in accounts receivable was the result of an increase in cash collections and decrease in revenue. The net decrease in accounts payable, accrued expenses and other current liabilities was primarily related to decreased expenses and timing of payments. The increase in inventory was primarily related to a decrease in sales compared to forecast and an increase in device and subassemblies inventory.
Six Months Ended June 30, 2024 (Restated)
During the six months ended June 30, 2024, operating activities used $17.6 million of cash resulting from a net loss of $6.3 million (as restated), non-cash income of $12.8 million (as restated), partially offset by net cash provided by changes in our operating assets and liabilities of $1.5 million.
Non-cash income consisted of $19.9 million of income related to the change in fair value of our earn-out liabilities, $8.1 million of income (as restated) related to the change in fair value of our convertible debt, $4.5 million of mark to market adjustments related to our warrant liabilities, $1.9 million of income related to the change in fair value of our term loan derivative liability, $1.4 million of debt issuance costs associated with debt at fair value, and $1.1 million of interest paid on debt recorded at fair value. This non-cash income was partially offset by a $8.7 million loss on the extinguishment of our Fortress Term Loan, an $8.1 million loss (as restated) related to the change in fair value of the Revenue Interest Financing and PIPE Conversion Option, $1.5 million of non-cash interest expense, $1.4 million of stock-based compensation expenses, $0.6 million of depreciation and amortization expense, $0.4 million of non-cash lease expense, $0.4 million of unrealized loss on foreign exchange, and a $0.4 million provision for inventory.
Net cash provided by changes in our operating assets and liabilities consisted of a $4.4 million decrease in accounts receivable, a $1.0 million decrease in inventory, and a $0.7 million decrease in prepaid expenses, other current and long-term assets, partially offset by a net $4.2 million decrease in accounts payable, accrued expenses and other current liabilities and a $0.4 million decrease in our lease liabilities.
The decrease in accounts receivable was the result of an increase in cash collections and decrease in revenue. The decrease in inventory was primarily related to a decrease in finished goods and work in progress. The decrease in prepaid expenses, other current and long-term assets was primarily related to a decrease in prepaid inventory and payroll deposits. The net decrease in accounts payable, accrued expenses and other current liabilities was primarily related to decreased expenses and timing of payments.
Net Cash Used in Investing Activities
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Six Months Ended June 30, 2025 and 2024
During the six months ended June 30, 2025 and June 30, 2024, cash used in investing activities was zero and $0.5 million, respectively, consisting of purchases of property and equipment.
Net Cash Provided by (Used in) Financing Activities
Six Months Ended June 30, 2025 and 2024
During the six months ended June 30, 2025, cash provided by financing activities was $14.4 million, consisting of a $13.7 million proceeds from public offerings, net of issuance costs and a $0.7 million of proceeds from our equity line financing.
During the six months ended June 30, 2024, cash used in financing activities was $0.7 million, consisting of a $47.7 million repayment of the Fortress Term Loan and a $1.4 million payment of debt issuance costs, partially offset by $48.0 million in proceeds from the issuance of convertible notes and $0.4 million of proceeds from our equity line financing.
Critical Accounting Policies and Estimates
Our condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of our condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
There have been no material changes in our critical accounting policies and significant judgments and estimates as compared to those disclosed in “Part II, Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K. See Note 3, Summary of Significant of Accounting Policies in the accompanying notes to the condensed consolidated financial statements included in Part 1, Item 1 of this Quarterly Report on Form 10-Q for additional details of our accounting policies.
Recent Accounting Pronouncements
See Note 3, Summary of Significant of Accounting Policies in the accompanying notes to the consolidated financial statements included in Part 1, Item 1 of this Quarterly Report on Form 10-Q for a description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows.
Emerging Growth Company and Smaller Reporting Company
We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act (“JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that (i) we are no longer an emerging growth company or (ii) we affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies.
Additionally, we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K, which allows us to take advantage of certain exemptions from disclosure requirements including exemption from compliance with the auditor attestation requirements of Section 404. We will remain a smaller reporting company until the last day of the fiscal year in which (i) the market value of the shares of our Common Stock held by non-affiliates exceeds $250 million as of the prior June 30, and (ii) our annual revenue exceeded $100 million during such completed fiscal year or the market value of the shares of our Common Stock held by non-affiliates exceeds $700 million as of the prior June 30. To the extent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies difficult or impossible.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Interest Rate Risk
We had cash and cash equivalents totaling $12.7 million at June 30, 2025. Cash equivalents were invested primarily in money market funds. Our investment policy is focused on the preservation of capital and supporting our liquidity needs. Under our investment policy, we invest in highly rated securities, issued by the U.S. government or liquid money market funds. We do not invest in financial instruments for trading or speculative purposes, nor do we use leveraged financial instruments. We utilize external investment managers who adhere to the guidelines of our investment policy. A hypothetical 10% change in interest rates would not have a material impact on the value of our cash, cash equivalents, net loss or cash flows.
As of June 30, 2025, we had no variable rate debt outstanding.
Foreign Currency Exchange Risk
We are exposed to foreign currency risks that arise from normal business operations. These risks include transaction gains and losses associated with transactions denominated in currencies other than a location’s functional currency and the remeasurement of foreign currencies to our U.S. dollar reporting currency. As such, we have exposure to adverse changes in exchange rates associated with operating expenses of our foreign operations. Transaction gains or losses are included in other income (expense), net in the consolidated statements of operations, as incurred.
We believe that a 10% increase or decrease in current exchange rates between the U.S. dollar and our foreign currencies could have a material impact on our business, financial condition or results of operations. Our primary exposures related to foreign currency denominated sales and expenses are in Europe and we also have exposure in the Middle East and the Asia-Pacific region, and are monitoring potential developing exposure in the Latin American, Canadian and African markets.
To date, we have not engaged in any foreign currency hedging activities. As our international operations grow, we will continue to reassess our approach to managing the risks relating to fluctuations in foreign currency exchange rates. During the six months ended June 30, 2025, the effect of an immediate 10% adverse change in foreign exchange rates on foreign-denominated accounts would have had an impact of approximately 5% on revenues and 4% on expenses and would have impacted our net income by approximately 3%. During the six months ended June 30, 2024, the effect of an immediate 10% adverse change in foreign exchange rates on foreign-denominated accounts would have had an impact of approximately 7% on revenues and 3% on expenses and would have impacted our net loss by approximately 6%.
Item 4. Controls and Procedures.
Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Securities Exchange Act of 1934, as amended (the "Exchange Act") is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure.
Evaluation of Disclosure Controls and Procedures
Our Chief Executive Officer, who is our principal executive officer and principal financial officer, has reviewed and evaluated the effectiveness of the Company's disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Exchange Act) as of the end of the period covered by this Quarterly Report on Form 10-Q. As described in the Explanatory Note to this Form 10-Q, while preparing its unaudited condensed consolidated financial statements for the quarter ended June 30, 2025, the Company identified an Error which led to the restatement of certain of the Company’s historical consolidated financial statements. The Company's management determined that the Error and the related restatements were the result of the existing material weaknesses in the Company’s internal control over financial reporting described above. The Company determined that the Error originated from the lack of sufficient levels of staff with public company and technical accounting experience to maintain proper control activities and perform risk assessment and monitoring activities.
Based on that review and evaluation, which included the Error and the related restatements, the Chief Executive Officer has concluded that the Company's disclosure controls and procedures were not effective as of June 30, 2025 as a result of the material weaknesses in our internal control over financial reporting discussed below.
In connection with the audits of our consolidated financial statements as of and for the years ended December 31, 2024 and 2023, we identified material weaknesses in our internal control over financial reporting that we are currently working to remediate, which relate to: (a) insufficient segregation of duties in the financial statement close process; (b) a lack of sufficient levels of staff with public company and technical accounting experience to maintain proper control activities and perform risk assessment and monitoring activities; and (c) insufficient information systems controls, including access and change management controls. We have concluded that these material weaknesses in our internal control over financial reporting occurred because we did not have the necessary business
55
processes, personnel and related internal controls to operate in a manner to satisfy the accounting and financial reporting timeline requirements prior to being a public company.
We are focused on designing and implementing effective internal controls measures to improve our evaluation of disclosure controls and procedures, including internal control over financial reporting, and remediating the material weaknesses. In order to remediate these material weaknesses, we have taken and plan to take the following actions:
While significant progress has been made to enhance our internal control over financial reporting, we are still in the process of building and enhancing our processes, procedures, and controls. Additional time is required to complete the remediation of these material weaknesses and the assessment to ensure the sustainability of these remediation actions. We believe the above actions, when complete, will be effective in the remediation of the material weaknesses described above.
Changes in Internal Control Over Financial Reporting
During the most recently completed fiscal quarter, there has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Limitations on Effectiveness of Controls and Procedures
In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
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PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may become involved in legal proceedings or be subject to claims arising in the ordinary course of our business. Except as described below, we are not currently a party to any material legal proceedings. Regardless of outcome, such proceedings or claims can have an adverse impact on the Company because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained.
On August 12, 2025, Vanderbilt University Medical Center (“Vanderbilt”) filed a complaint against the Company in the United States District Court for the Middle District of Tennessee, captioned Vanderbilt University Medical Center v. Allurion Technologies, Inc., d/b/a Allurion. Vanderbilt’s complaint alleges that the Company breached the Clinical Trial Agreement, dated June 30, 2022, by and between the Company and Vanderbilt, related to the clinical trial for the Allurion Balloon by failing to reimburse medical expenses incurred in treating a patient enrolled in such trial at Vanderbilt. Vanderbilt is seeking damages of approximately $2.5 million. The Company intends to defend against such claims vigorously, but cannot assure you that it will be successful in prevailing in such proceeding or that it will not incur material costs in defending against such allegations.
Item 1A. Risk Factors.
Information regarding risk factors appears in Part I, Item 1A. "Risk Factors" of our Annual Report on Form 10-K. Except as set forth below, there have not been any material changes from the risk factors set forth in our Annual Report on Form 10-K. In addition to the matters set forth herein, investors should review the risks factors and other information provided in the Annual Report on Form 10-K prior to making an investment in the Company. Our business, financial condition and operating results can be affected by a number of factors, whether currently known or unknown, including but not limited to those described in the Annual Report on Form 10-K, any one or more of which could, directly or indirectly, cause our actual financial condition and operating results to vary materially from past, or from anticipated future, financial conditions and operating results. Any of these factors, in whole or in part, could materially and adversely affect our business, financial condition, operating results and stock price.
Our strategic restructuring and cash preservation activities, including the reduction in force, may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business.
In August 2025, we implemented a strategic restructuring, including a reduction in force. In connection with the reduction in force, we expect to incur costs of approximately $1.5 million, which are primarily one-time severance benefits. We may not realize, in full or at all, the anticipated benefits, savings and improvements in our cost structure from our restructuring efforts due to unforeseen difficulties, delays or unexpected costs. If we are unable to realize the expected operational efficiencies and cost savings from the restructuring, our operating results and financial condition would be adversely affected. Furthermore, our reduction in force may be disruptive to our operations. For example, headcount reductions could yield unanticipated consequences, such as increased difficulties in implementing our business strategy, including retention of remaining employees.
Due to our limited resources, we may not be able to effectively manage our operations, which may result in weaknesses in our infrastructure, risks that we may not be able to comply with legal and regulatory requirements, and loss of employees and reduced productivity among remaining employees. For example, our limited resources and workforce reduction may negatively impact our R&D and clinical trial activities or expose us to cybersecurity risks, which could result in unexpected costs and expenses and have a material adverse effect on our business, financial condition and prospects.
The U.S. Congress, the presidential administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.
The rules dealing with U.S. federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service (“IRS”) and the U.S. Treasury Department. For example, the One Big Beautiful Bill Act (“OBBBA”) was signed into law on July 4, 2025 and made significant changes to U.S. federal tax law. Changes to tax laws (which changes may have retroactive application) could adversely affect us or holders of our common stock. For example, under Section 174 of the IRC, in taxable years beginning after December 31 2021, expenses that are incurred for research and development performed outside the U.S. will be capitalized and amortized, which may have an adverse effect on our cash flow. The OBBBA provides that for taxable years beginning after December 31, 2024, expenses that are incurred for research and development performed in the U.S. may, at the taxpayer’s election, be immediately deducted or capitalized and amortized. In addition, the OBBBA provides that for taxable years beginning after December 31, 2021 and before January 1, 2025, certain eligible taxpayers generally may elect to retroactively deduct expenses for research and development performed in the U.S. in such taxable years generally may elect to accelerate and deduct the remaining unamortized amounts of such research and development expenses (i) in the first taxable year beginning after December 31, 2024, or (ii) ratably over the two-taxable year period beginning with the first taxable year beginning after December 31 2024. In recent years, many changes to tax laws have been made and changes are likely to continue to occur in the future.
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In addition, since the start of the new administration in 2025, United States policy changes have been implemented at a rapid pace and additional changes are likely. Changes to United States policy implemented by the U.S. Congress, the presidential administration or any new administration have impacted and may in the future impact, among other things, the United States and global economy, international trade relations, unemployment, immigration, health care, taxation, the United States regulatory environment, inflation and other areas. Although we cannot predict the impact, if any, of these changes to our business, such changes could adversely affect our business. Until we know what policy changes are made, whether those policy changes are challenged and subsequently upheld by the court system and how those changes impact our business and the business of our competitors over the long term, we will not know if, overall, we will benefit from them or be negatively affected by them.
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Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities
Unregistered Sales of Equity Securities, Use of Proceeds
Not applicable.
Issuer Purchases of Equity Securities
Not applicable.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
(c)
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Item 6. Exhibits.
The following list of exhibits includes exhibits submitted with this Quarterly Report on Form 10-Q as filed with the SEC and those incorporated by reference to other filings.
Exhibit Number |
|
Description |
Incorporated by Reference herein from - Form or Schedule |
File Number |
Exhibit |
Filed Date |
3.1 |
|
Amended and Restated Certificate of Incorporation of Allurion Technologies, Inc. (f/k/a Allurion Technologies Holdings, Inc.) |
8-K |
001-41767 |
3.1 |
August 7, 2023 |
3.2 |
|
Bylaws of Allurion Technologies, Inc. (f/k/a Allurion Technologies Holdings, Inc.) |
8-K |
001-41767 |
3.2 |
August 7, 2023 |
4.1 |
|
Warrant Agreement, dated February 4, 2021, between Compute Health Acquisition Corp. and Continental Stock Transfer & Trust Company, as warrant agent. |
8-K |
001-40001 |
4.1 |
February 9, 2021 |
4.2 |
|
Amendment to Warrant Agreement, dated August 1, 2023, by and between Compute Health and Continental Stock Transfer & Trust Company. |
8-K |
001-41767 |
4.2 |
August 7, 2023 |
4.3 |
|
Warrant Assignment, Assumption and Amendment Agreement, dated August 1, 2023, by and among Compute Health Acquisition Corp., New Allurion Holdings, Inc., and Continental Stock Transfer & Trust Company. |
8-K |
001-41767 |
4.3 |
August 7, 2023 |
4.4 |
|
Form of Public Warrant. |
8-K |
001-41767 |
4.1 |
July 1, 2024 |
4.5 |
|
Form of Private Placement Warrant. |
8-K |
001-41767 |
4.2 |
July 1, 2024 |
4.6 |
|
Form of Common Warrant (January 2025) |
8-K |
001-41767 |
4.1 |
January 28, 2025 |
4.7 |
|
Form of Common Warrant (February 2025) |
8-K |
001-41767 |
4.1 |
February 21, 2025 |
4.8 |
|
Form of Private Placement Warrant (February 2025) |
8-K |
001-41767 |
4.2 |
February 21, 2-25 |
10.1 |
|
Second Amendment to Note Purchase Agreement, dated as of April 15, 2025, by and among Allurion Technologies, Inc., the purchasers party thereto, and RTW Investments, L.P. as agent for the purchasers. |
8-K |
001-41767 |
10.1 |
April 17, 2025 |
10.2* |
|
Eighth Amendment to 11 Huron Lease, dated as of June 20, 2025, by and between Allurion Technologies, Inc. and Legacy Huron, LLC. |
|
|
|
|
31.1* |
|
Certification of Principal Executive Officer and Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
|
32.1** |
|
Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
|
101.INS |
|
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
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101.SCH |
|
Inline XBRL Taxonomy Extension Schema Document |
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|
101.CAL |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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|
|
101.DEF |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB |
|
Inline XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
|
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|
|
* Filed herewith.
** Furnished herewith
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
Allurion Technologies, Inc. |
|
|
|
|
|
Date: August 19, 2025 |
|
By: |
/s/ Shantanu Gaur |
|
|
|
Shantanu Gaur |
|
|
|
Chief Executive Officer and President |
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FAQ
What did Allurion disclose about its financial reporting?
How large is Allurion's restructuring and what are the costs?
How much recent financing did Allurion complete?
What are the terms of the Revenue Interest Financing?
Does Allurion face any material litigation?
What product and clinical developments did the company report?
