ALUR 10-K & 10-Q changes, risk factors and insider trading
Allurion Technologies, Inc. (also ALURW) · OTC · Surgical & Medical Instruments & Apparatus · CIK 1964979 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “We have incurred losses to date and expect to incur losses for the foreseeable future, our ability to achieve and maintain profitability depends on the commercial success of the Allurion Smart Capsule, and we expect our revenues to continue to be driven primarily by sales of the Allurion Smart Capsule.”
New heading “Commercial success of the Allurion Smart Capsule in the United States or elsewhere depends on our ability to accurately forecast customer demand and manufacture sufficient quantities of product that patients and health care providers request, and to manage inventory effectively. The failure to do so could have a material adverse effect on our business, financial condition, results of operations and growth prospects.”
New heading “Except for limited exceptions, we do not expect health care providers or patients will receive third-party reimbursement for treatment with our products in the near future. As a result, we expect that our success will depend on the ability and willingness of health care providers to adopt self-pay practice management infrastructure and of patients to pay out-of-pocket for treatment with our products.”
New heading “Changes in coverage and reimbursement for obesity treatments and procedures could affect the adoption of the Allurion Program and our future revenues.”
New heading “The Allurion Gastric Balloon System, featuring the Allurion Smart Capsule, is approved in more than 80 countries, including the United States and the European Union. Maintaining regulatory approval in these jurisdictions may require further clinical trials and investment and cannot be guaranteed.”
New heading “Upon receipt of regulatory approval to market the Allurion Smart Capsule in a given jurisdiction, we are (or will be) subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements.”
New heading “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.”
New heading “We have restated certain of our previously issued financial statements, which may lead to additional risks and uncertainties, including unanticipated costs, legal proceedings and regulatory actions, and may adversely affect investor confidence, our share price, our reputation and our ability to raise capital in the future.”
New heading “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.”
New heading “The suspension or delisting of our securities from the NYSE gives the holder of our convertible notes, at its option, to require the Company to repurchase these notes for cash.”
New heading “Our Securities Trade on an Over‑the‑Counter Market, Which Subjects Investors to Significant Risks Related to Liquidity, Volatility, and Limited Market Visibility.”
New heading “An active trading market may not be available on a consistent basis to provide stockholders with adequate liquidity. The price of our Common Stock may be extremely volatile, and stockholders could lose all or part of their investment.”
Removed heading “We expect to incur losses for the foreseeable future, our ability to achieve and maintain profitability depends on the commercial success of the Allurion Balloon, and we expect our revenues to continue to be driven primarily by sales of the Allurion Balloon.”
Removed heading “We do not expect that health care providers or patients will receive third-party reimbursement for treatment with our products. As a result, we expect that our success will depend on the ability and willingness of health care providers to adopt self-pay practice management infrastructure and of patients to pay out-of-pocket for treatment with our products.”
Removed heading “There is no guarantee that the FDA or non-U.S. regulatory agencies will grant approval or clearance for our current or future products, including the Allurion Balloon. Failure to obtain regulatory approvals or clearances in the United States and other international jurisdictions, or revocation of approvals or clearances in those jurisdictions, will prevent us from marketing and selling our products in such jurisdictions.”
Removed heading “The Allurion Balloon is not currently approved for commercial sale in the United States. Obtaining such approval is costly and time consuming, and we may not obtain the regulatory approval required to market and sell our products in the U.S.”
Removed heading “Even if clinical trials demonstrate acceptable safety and efficacy for the Allurion Balloon in some patient populations, the FDA or similar regulatory authorities outside the U.S. may not approve the marketing of the Allurion Balloon or may approve it with restrictions on the label, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.”
Removed heading “The results of preclinical studies and earlier clinical trials may not be predictive of the results of later preclinical studies and clinical trials, and the results of our current and future clinical trials may not satisfy the requirements of the FDA or other comparable regulatory authorities. If we cannot replicate the positive results from our preclinical studies or earlier clinical trials of the Allurion Balloon in our current or future clinical trials, we may be unable to successfully develop, obtain regulatory approval for and commercialize our current or future product candidates.”
Removed heading “Commercial success of the Allurion Balloon in the United States or elsewhere depends on our ability to accurately forecast customer demand and manufacture sufficient quantities of product that patients and health care providers request, and to manage inventory effectively. The failure to do so could have a material adverse effect on our business, financial condition, results of operations and growth prospects.”
Removed heading “The regulatory approval process is expensive, time consuming and uncertain, and may prevent us from obtaining approvals for the commercialization of the Allurion Balloon or our planned products.”
Removed heading “Upon receipt of regulatory approval to market the Allurion Balloon in a given jurisdiction, we are (or will be) subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements.”
Removed heading “Our AllurionMeds program offers patients access to compounded semaglutide. Compounded drugs, including compounded semaglutide, have been subject to increased scrutiny by the FDA, state governmental agencies, and other third-parties, and may expose us to a variety of risks that could result in an adverse impact on our business or reputation.”
Removed heading “An active trading market may not develop or be sustained.”
Largest changes
“The restatement of our previously issued financial statements was time-consuming and expensive. The restatement, the related material weaknesses in our internal control over financial reporting, and other related impacts could expose us to additional risks that could materially adversely affect our financial position, results of operations and cash flows, including unanticipated costs for accounting and legal fees in connection with or related to the restatement and various legal and regulatory challenges. …”see in full comparison
“The restatement of our previously issued financial statements, the related material weaknesses in our internal control over financial reporting, and other related impacts could result in increased volatility in the market price of our securities. We may also experience reduced analyst coverage and diminished interest from institutional investors, which could adversely impact the trading volume, liquidity, and market price of our securities. …”see in full comparison
“Our success will also depend on the ability and willingness of patients to pay out-of-pocket for treatment with our products. Adverse changes in the economy, including from heightened inflation, higher interest rates, and geopolitical conflicts such as the Russia-Ukraine war, the Israel-Hamas war, and the Israel/United States - Iran war may cause consumers to reassess their spending choices and reduce the demand for elective treatments and could have an adverse effect on consumer spending. This shift could have an adverse effect on our revenues and operating results. …”see in full comparison
“Our success will also depend on the ability and willingness of patients to pay out-of-pocket for treatment with our products. Adverse changes in the economy, including from heightened inflation, higher interest rates, and geopolitical conflicts such as the Russia-Ukraine war and the Israel-Hamas war, may cause consumers to reassess their spending choices and reduce the demand for elective treatments and could have an adverse effect on consumer spending. This shift could have an adverse effect on our revenues and operating results. …”see in full comparison
“The suspension or delisting of our securities from the NYSE gives the holder of our convertible notes, at its option, to require the Company to repurchase these notes for cash.”see in full comparison
“Additionally, if we are found to have manufactured, distributed, marketed, sold, or labeled any products in violation of applicable regulatory requirements, we may face significant penalties which may result in a material adverse effect on our business, financial condition, and results of operations. Certain 503B outsourcing facilities have been subject to negative media coverage, governmental inquiries and actions, and litigation in recent years, including with respect to compounded GLP-1s. …”see in full comparison
Full comparison: every changed paragraph (213)
We have incurred losses to date and expect to incur losses for the foreseeable future. Our ability to achieve and maintain profitability depends on the commercial success of the Allurion Balloon, and we expect our revenues to continue to be driven primarily by sales of the Allurion Balloon.
We have incurred losses to date and expect to incur losses for the foreseeable future. Our ability to achieve and maintain profitability depends on the commercial success of the Allurion Smart Capsule, and we expect our revenues to continue to be driven primarily by sales of the Allurion Smart Capsule.
The failure of the Allurion BalloonSmart or our new compounded GLP-1 programCapsule to achieve and maintain market acceptanceacceptance, especially in the United States where we just received FDA approval in February 2026, could result in achieving sales or profitability below our expectations, which would cause our business, financial condition, and operating results to be materially and adversely affected.
Commercial success of the Allurion Smart Capsule in the United States or elsewhere depends on our ability to accurately forecast customer demand and manufacture sufficient quantities of product that patients and health care providers request, and to manage inventory effectively. The failure to do so could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
There is no guarantee that the FDA or non-U.S. regulatory agencies will grant approval or clearance for our current or future products, and failure to obtain regulatory approvals or clearances in the United States and international jurisdictions, or revocation of approvals or clearances in those jurisdictions, will prevent us from marketing and selling our products.
The Allurion Balloon is not currently approved for commercial sale in the United States. Obtaining such approval is costly and time consuming, and we may not obtain the regulatory approval required to sell the Allurion Balloon in the United States.
Our current international operations and any expansion of our business in the United States or internationally expose us to business, regulatory, political, operational, financial, and economic risks associated with doing business internationally.
Except for limited exceptions, we do not expect health care providers or patients will receive third-party reimbursement for treatment with our products in the near future. As a result, we expect that our success will depend on the ability and willingness of health care providers to adopt self-pay practice management infrastructure and of patients to pay out-of-pocket for treatment with our products.
The misuse or off-label use of our products may harm our image in the marketplace, result in injuries that lead to product liability suits or result in costly investigations and sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
The failure of third parties to meet their contractual, regulatory, and other obligations could adversely affect our business.
The regulatory approval process is expensive, time consuming, and uncertain, and may prevent us from obtaining approvals for the commercialization of the Allurion Balloon or other products.
Even if we receivewith regulatory approval for the Allurion Balloon in the United States and elsewhere, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements.
The regulatory approval process is expensive, time consuming, and uncertain, and may prevent us from obtaining approvals for the commercialization of the Allurion Smart Capsule or other products.
We have incurred net operating losses in the past and expect to incur net operating losses for the foreseeable future.future, and there is substantial doubt about our ability to continue as a going concern.
We receive the majority of our revenue from sales to health care providers and other third-party distributors, and the failure to collect receivables from them could adversely affect our financial position and results of operations.
We have restated certain of our previously issued financial statements, which may lead to additional risks and uncertainties, including unanticipated costs, legal proceedings and regulatory actions, and may adversely affect investor confidence, our share price, our reputation and our ability to raise capital in the future.
Trading of our securities on the NYSE was suspended for failure to meet the NYSE's market capitalization standard, and failure to resume trading on the NYSE or a permanent delisting of our securities by the NYSE could have an adverse impact on the perception of our Company and its securities, the trading volume, liquidity, volatility, and market price of our common stock, and our ability to raise capital on favorable terms.
Our Securities Trade on an Over‑the‑Counter Market, Which Subjects Investors to Significant Risks Related to Liquidity, Volatility, and Limited Market Visibility.
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.
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.
We expect to incur losses for the foreseeable future, our ability to achieve and maintain profitability depends on the commercial success of the Allurion Balloon, and we expect our revenues to continue to be driven primarily by sales of the Allurion Balloon.
We have incurred losses to date and expect to continue to incur losses for the foreseeable future. Sales of the Allurion Balloon and related accessories, which have occurred outside of the U.S. because we have not yet obtained the regulatory approval required to sell our products within the U.S., accounted for substantially all of our revenues for the years ended December 31, 2024 and 2023, and we expect our revenues to continue to be driven primarily by sales of the Allurion Balloon. In order to achieve and sustain profitability, our revenues from sales of the Allurion Balloon will need to grow beyond the levels we have achieved in the past. If health care providers and/or patients do not perceive our products to be competitive in features, efficacy and safety when compared to other products in the market, or if demand for the Allurion Balloon or for weight loss procedures and programs in general decreases, we may fail to achieve sales levels that provide for future profitability.
Our ability to successfully market the Allurion Balloon and our other current and future product and service offerings depends on numerous factors, including but not limited to:
acceptance of the Allurion Balloon as safe and effective by patients, caregivers and the medical community;
an acceptable safety profile of the Allurion Balloon in markets where we have obtained regulatory approvals;
successful completion of remediation programs to resume sales of the Allurion Balloon in any country that suspends sales of our products;
outcomes of current and future clinical trials of, and trials involving, the Allurion Balloon;
our success in educating health care providers and patients about the benefits, administration and use of the Allurion Balloon;
the willingness of patients to pay out-of-pocket for the Allurion Balloon and/or Allurion VCS in the absence of coverage and reimbursement for such treatment;
Some of these factors are beyond our control. If we are unable to continue to commercialize the Allurion Balloon and our other current and future products and services, or are unable to obtain distributors or partners to commercialize them, we may not be able to produce any incremental revenues related to the Allurion Balloon and our other current and future products and services. This would result in an adverse effect on our business, financial condition, results of operations and growth prospects.
The Allurion BalloonSmart Capsule has been marketed in countries outside of the United States since 2016,2016 and in the United States since March 2026, and as such, we have a limited operating history upon which to evaluate our business and forecast our future revenue and operating results. In assessing our business prospects, you should consider the various risks and difficulties frequently encountered by companies early in their commercialization in competitive markets, particularly companies that develop and sell medical devices. These risks include our ability to:
We have incurred losses to date and expect to incur losses for the foreseeable future, our ability to achieve and maintain profitability depends on the commercial success of the Allurion Smart Capsule, and we expect our revenues to continue to be driven primarily by sales of the Allurion Smart Capsule.
We have incurred losses to date and expect to continue to incur losses for the foreseeable future. Sales of the Allurion Smart Capsule and related accessories, which have occurred outside of the U.S. accounted for substantially all of our revenues for the years ended December 31, 2025 and 2024, and we expect our revenues to continue to be driven primarily by sales of the Allurion Smart Capsule. In order to achieve and sustain profitability, our revenues from sales of the Allurion Smart Capsule will need to grow beyond the levels we have achieved in the past. If health care providers and/or patients do not perceive our products to be competitive in features, efficacy and safety when compared to other products in the market, or if demand for the Allurion Smart Capsule or for weight loss procedures and programs in general decreases, we may fail to achieve sales levels that provide for future profitability.
Our ability to successfully market the Allurion Smart Capsule and our other current and future product and service offerings depends on numerous factors, including but not limited to:
acceptance of the Allurion Smart Capsule as safe and effective by patients, caregivers and the medical community;
an acceptable safety profile of the Allurion Smart Capsule in markets where we have obtained regulatory approvals;
successful completion of remediation programs to resume sales of the Allurion Smart Capsule in any country that suspends sales of our products;
outcomes of current and future clinical trials of, and trials involving, the Allurion Smart Capsule;
our success in educating health care providers and patients about the benefits, administration and use of the Allurion Smart Capsule;
the willingness of patients to pay out-of-pocket for the Allurion Smart Capsule and/or Allurion VCS in the absence of coverage and reimbursement for such treatment;
Some of these factors are beyond our control. If we are unable to continue to commercialize the Allurion Smart Capsule and our other current and future products and services, or are unable to obtain distributors or partners to commercialize them, we may not be able to replicate existing, or produce any incremental revenues related to the Allurion Smart Capsule and our other current and future products and services. This would result in an adverse effect on our business, financial condition, results of operations and growth prospects.
We do not expect that health care providers or patients will receive third-party reimbursement for treatment with our products. As a result, we expect that our success will depend on the ability and willingness of health care providers to adopt self-pay practice management infrastructure and of patients to pay out-of-pocket for treatment with our products.
Certain elective treatments, such as an intragastric balloon, are typically not covered by insurance. Accordingly, we do not expect that any third-party payors will cover or reimburse health care providers or patients for the Allurion Program. As a result, we expect that our success will depend on the ability and willingness of health care providers that may not have historically operated a self-pay practice to adopt the policies and procedures needed to successfully operate such a practice. Our sales and marketing efforts have historically targeted bariatric surgeons, gastroenterologists, plastic surgeons and other health care providers.
Our success will also depend on the ability and willingness of patients to pay out-of-pocket for treatment with our products. Adverse changes in the economy, including from heightened inflation, higher interest rates, and geopolitical conflicts such as the Russia-Ukraine war and the Israel-Hamas war, may cause consumers to reassess their spending choices and reduce the demand for elective treatments and could have an adverse effect on consumer spending. This shift could have an adverse effect on our revenues and operating results. In addition, the operations of the medical device distributors upon whom we rely to sell our products may be negatively impacted by any such adverse economic changes. If our distributors are unable to maintain their operations and effectively market and sell our products, our results of operations and business may suffer.
Furthermore, consumer preferences and trends may shift due to a variety of factors, including changes in demographic and social trends, public health initiatives and product innovations, which may reduce consumer demand for our products. The decision by a patient to elect to undergo treatment with the Allurion Balloon may be influenced by a number of additional factors, such as:
the extent to which health care providers offer the Allurion Balloon to their patients;
the extent to which the Allurion Balloon satisfies patient expectations;
Our financial performance will be materially harmed if we cannot generate significant customer demand for the Allurion Balloon.
Historically, intragastric balloon products are not reimbursed by third-party payors, although a very limited number of balloon procedures have been subject to reimbursement in the U.K. market. We do not currently plan on submitting any requests to any third-party payor for coverage or billing codes specific to our products other than as allowed by the National Health Service in the United Kingdom. However, payors may change their coverage and reimbursement policies for intragastric balloon products as a category and/or for other obesity treatments and procedures, and these changes could negatively impact our business. For example, healthcare reform legislation or regulation that may be proposed or enacted in the future that results in a favorable change in coverage and reimbursement for competitive products and procedures in weight loss and obesity could also negatively impact adoption of our products and our future revenues, and our business could be harmed as we would be at an economic disadvantage when competing for customers. For more information, see section entitled "Business - Government Regulation - Other U.S. Healthcare Laws - Coverage, Reimbursement and Healthcare Reform."
The failure of the Allurion BalloonSmart Capsule to achieve and maintain market acceptanceacceptance, especially in the United States where we just received FDA approval in February 2026, could result in us achieving sales below our expectations, which would cause our business, financial condition and operating results to be materially and adversely affected.
Our current business and growth strategy is highly dependent on the Allurion BalloonSmart Capsule achieving and maintaining market acceptance.acceptance, including in the United States, a geography in which we have no commercial history. In order for us to sell our products to healthcare providers and, ultimately, weight loss patients, we must convince them that our products are an attractive alternative to competitive treatments for patients who are obese and overweight, including traditional pharmaceutical therapies and more aggressive bariatric surgical treatments, such as gastric bypass and sleeve gastrectomy. Market acceptance and adoption of the Allurion BalloonSmart Capsule depends on educating health care providers on its safe and appropriate use, as well as the cost, safety, comfort, tolerability, ease of use, and effectiveness of the Allurion Program compared to other treatments. If we are not successful in convincing existing and potential customers of the benefits of our product, or if we are not able to achieve the support of health care providers for our product, our sales may decline or we may achieve sales below our expectations.
lack of evidence supporting the safety, ease-of-use or other perceived benefits of the Allurion BalloonSmart Capsule over competitive products or other currently available weight loss treatment alternatives;
any adverse legal action, including products liability litigation, against us or our competitors relating to the Allurion BalloonSmart Capsule or similar products or technologies;
the withdrawal or modification of any regulatory approvals for our products; and results of clinical studies relating to the Allurion BalloonSmart Capsule or similar competitive products.
If the Allurion Balloon,Smart Capsule, or any other therapy or product that we may develop, does not achieve and maintain widespread market acceptance, we may fail to achieve sales consistent with our projections, in which case our business, financial condition and operating results could be materially and adversely affected.
Commercial success of the Allurion Smart Capsule in the United States or elsewhere depends on our ability to accurately forecast customer demand and manufacture sufficient quantities of product that patients and health care providers request, and to manage inventory effectively. The failure to do so could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
Manufacturing of the Allurion Smart Capsule requires capital expenditures and a highly-skilled workforce. There is a significant lead time to build and certify a new manufacturing facility. Although we believe our current facilities will give us adequate manufacturing capacity to meet demand for at least the next two years, we have, in the past, been unable to fill all incoming orders to meet growing demand. Having received FDA approval, we intend to rely on our existing manufacturing facilities to supply products in the United States. If demand increases faster than we expect, or if we are unable to produce the quantity of goods that we expect with our current facilities, we may not be able to grow revenue at an optimal rate. There may be other negative effects from supply shortages, including loss of our reputation in the marketplace and a negative impact on our relationships with our distributors, which could have a material adverse effect on our business, financial condition, results of operations, and growth prospects. We may also need to engage others to assist with the manufacture our products, a process which requires extensive time and resources, and we cannot guarantee that any manufacturing partner would be able to manufacture our products to our specifications and quality standards.
Except for limited exceptions, we do not expect health care providers or patients will receive third-party reimbursement for treatment with our products in the near future. As a result, we expect that our success will depend on the ability and willingness of health care providers to adopt self-pay practice management infrastructure and of patients to pay out-of-pocket for treatment with our products.
Certain elective treatments, such as an intragastric balloon, are typically not covered by insurance. Accordingly, we do not expect, except with limited exceptions, that any third-party payors will cover or reimburse health care providers or patients for the Allurion Program. As a result, we expect that our success will depend on the ability and willingness of health care providers that may not have historically operated a self-pay practice to adopt the policies and procedures needed to successfully operate such a practice. Our sales and marketing efforts have historically targeted bariatric surgeons, gastroenterologists, plastic surgeons and other health care providers.
Our success will also depend on the ability and willingness of patients to pay out-of-pocket for treatment with our products. Adverse changes in the economy, including from heightened inflation, higher interest rates, and geopolitical conflicts such as the Russia-Ukraine war, the Israel-Hamas war, and the Israel/United States - Iran war may cause consumers to reassess their spending choices and reduce the demand for elective treatments and could have an adverse effect on consumer spending. This shift could have an adverse effect on our revenues and operating results. In addition, the operations of the medical device distributors upon whom we rely to sell our products may be negatively impacted by any such adverse economic changes. If our distributors are unable to maintain their operations and effectively market and sell our products, our results of operations and business may suffer.
Management's Discussion & Analysis (MD&A)
New heading “Exchange Agreement”
New heading “Warrant Inducement”
New heading “NYSE Continued Listing Standards”
New heading “Note Purchase Agreement”
New heading “November 2025 Private Placement”
New heading “Exchange Agreement with RTW”
Removed heading “Reverse Stock Split”
Removed heading “Omnibus Amendment”
Removed heading “Topline AUDACITY FDA Pivotal Trial Results”
Removed heading “January 2025 Public Offering and Concurrent Private Placement”
Removed heading “February 2025 Public Offering and Concurrent Private Placement”
Removed heading “Leavitt Private Placement”
Removed heading “Resumption of Sales in France”
Removed heading “Termination of convertible note side letters”
Removed heading “Termination of Convertible Note Side Letters”
Removed heading “Revenue Interest Financing Agreement”
Largest changes
“On March 6, 2026, the NYSE notified the Company that it has determined to commence proceedings to delist the Company’s Common Stock, and warrants to purchase 0.056818 shares of Common Stock, with an exercise price of $202.50 per share of Common Stock, as a result of the Company’s non-compliance with Rule 802.01B of the NYSE Listed Company Manual that requires listing companies to maintain an average global market capitalization of at least $15 million over a period of 30 consecutive trading days. Trading in the Common Stock on the NYSE was suspended after market close on March 6, 2026. …”see in full comparison
“On March 2, 2026, the Company announced that it received a letter (the “Delisting Notice”) from the staff of the NYSE indicating that the Company does not meet certain of the NYSE's continued listing standards as set forth in the Minimum Market Capitalization Standard. The Company has a right to a review of this determination by a Committee of the Board of Directors of the Exchange (the “Committee”). The Company has appealed this delisting determination.”see in full comparison
“As a result of the suspension in trading and delisting process pending the Company’s appeal, the Common Stock is trading on the OTCID Market. The Company intends to apply to list on a higher-tier market operated by the OTC Market Group, Inc. under its current symbols "ALUR" and “ALUR WS”.”see in full comparison
“Pursuant to the Omnibus Amendment, RTW shall receive a number of shares of the common stock, representing 5.0% of the fully-diluted shares outstanding (without regard to any beneficial ownership blockers) 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 (the “Amendment Fee”); …”see in full comparison
“February 2025 Public Offering and Concurrent Private Placement”see in full comparison
Full comparison: every changed paragraph (118)
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, ProcedurelessTM intragastric balloon for weight loss (the "Allurion BalloonSmart Capsule") 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").
Our proprietary intragastric balloon, the Allurion Balloon,Smart Capsule, is swallowed as a capsule under the guidance of a health care provider without surgery, endoscopy, or anesthesia.anesthesia for placement.
In addition to its use by Allurion BalloonSmart Capsule 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. AllurionMeds is currently only available in the United States.
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 $32.1$15.23 million and $53.5$32.1 million for the years ended December 31, 20242025 and 2023,2024, respectively, and incurred netoperating losses of $26.1$30.1 million and $80.6$50.2 million for those same periods, respectively. We expect to continue to incur netoperating 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.
Reverse Stock Split
On January 3, 2025, our 1-for-25 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 OpCo, Allurion Australia Pty Ltd, Allurion France, the Additional RIFA Investors and RTW, as agent for the Purchasers, to amend the Amended Note Purchase Agreement and the RIFAs (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 U.S. in the amounts corresponding to the calculations set forth therein, and (ii) the Company to receive minimum trailing twelve-month consolidated Revenue (as defined in the Existing Documents) at amounts designated in the Omnibus Amendment, tested quarterly beginning with the twelve-month period ending September 30, 2025. The Omnibus Amendment also requires that (i) Allurion France shall have successfully regained marketing authorization from the ANSM (defined below) to resume the Commercialization (as defined in the Existing Documents) of the Product (as defined in the Existing Documents) in France on or prior to December 31, 2025, which occurred in February 2025 as noted below, and (ii) Allurion OpCo shall have received Marketing Authorization from the FDA for the Commercialization of the Product in the United States no later than June 30, 2026.
Pursuant to the Omnibus Amendment, RTW shall receive a number of shares of the common stock, representing 5.0% of the fully-diluted shares outstanding (without regard to any beneficial ownership blockers) 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 (the “Amendment Fee”); provided that, in the event we cannot issue shares of common stock to the Purchasers 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 (the “Redemption Date”) 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 U.S. Food and Drug Administration ("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, we plan to submit the fourth and final module of the premarket approval application (“PMA”) to the FDA.
JanuaryNovember 2025 RTWSecurities PrivatePurchase PlacementAgreement
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 sell 841,751 shares of its common stock for an aggregate purchase price of approximately $2.5 million at a purchase price per share of $2.97 (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 Common Warrants in a concurrent private placement (the “January 2025 Private Placement”), at an offering price of $6.00 per share and accompanying January 2025 Common Warrant.
The January 2025 Offering and January 2025 Private Placement resulted in gross proceeds of approximately $7.4 million, before deducting the placement agent fees and commissions and estimated offering expenses payable by the Company. The January 2025 Offering and January 2025 Private Placement closed on January 27, 2025. We intend to use the net proceeds of the January 2025 Offering and January 2025 Private Placement for working capital and other general corporate purposes.
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 Common Warrants in a concurrent private placement (the “February 2025 Private Placement”), at an offering price of $5.23 per share and accompanying Common Warrant.
The February 2025 Offering and February 2025 Private Placement resulted in gross proceeds of approximately $4.7 million, before deducting the placement agent fees and commissions and estimated offering expenses payable by the Company. The February 2025 Offering and February 2025 Private Placement closed on February 20, 2025. We intend to use the net proceeds of the February 2025 Offering and February 2025 Private Placement to fund our clinical pipeline testing the effects of the combination of the Allurion Balloon and GLP-1 therapy on muscle mass and long-term GLP-1 adherence, for working capital and other general corporate purposes.
Leavitt Private Placement
On FebruaryNovember 19,11, 2025, we entered into a subscriptionsecurities purchase agreement (the “Leavitt"November Subscription2025 Securities Purchase Agreement”") with ancertain accredited investorinvestors affiliatednamed with Leavitt Equity Partners LLC (collectively, “Leavitt”),therein, pursuant to which we agreed to issue and sell to Leavitt 267,6862,994,012 shares of commonour stockCommon (the “Private Placement Shares”)Stock and accompanying common warrants to purchase up to 535,3722,994,012 shares of commonCommon stockStock (the “Leavitt"November 2025 Private Placement Warrants” and together with the Private Placement Shares, the “Private Placement Securities”"), for an aggregate purchase price of approximately $1.4$5.0 million at a purchase price of $5.23$1.67 per share and accompanying PrivateNovember Placement Warrant (the “Leavitt Private Placement”). The Leavitt2025 Private Placement closed on February 20, 2025.Warrant.
Exchange Agreement
On November 11, 2025, we entered into a securities purchase and exchange agreement (the "Exchange Agreement") with certain entities managed by RTW, pursuant to which RTW has agreed to exchange all of the (i) principal amount of convertible senior secured notes (the "Notes"), purchased pursuant to the terms of the Amended Note Purchase Agreement, including interest accrued on the Notes; (ii) Company obligations under the Revenue Interest Financing Agreement; and (iii) Company obligations under the New RIFA (together with the Revenue Interest Financing Agreement, the "RIFAs") for shares of a newly issued class of Series B convertible preferred stock, par value $0.0001 per share ("Series B Preferred Stock") of the Company (the "Exchange"). RTW's obligation to consummate the closing of the Exchange is conditioned upon, among other things, the receipt of stockholder approval of the issuance of Series B Preferred Stock no later than January 31, 2026. The terms of the Series B Preferred Stock are described in our Current Report on Form 8-K, filed with the SEC on November 12, 2025.
FDA Approval
On February 20, 2026, the U.S. Food and Drug Administration (“FDA”) granted PMA approval for the Allurion Gastric Balloon System (AGBS), featuring the Allurion Smart Capsule. In the United States, the AGBS is indicated to promote short-term limited weight loss in adult individuals with obesity between the ages of 22 years and 65 years with a body mass index (BMI) ≥ 30 kg/m2 and ≤ 40 kg/m2 who have had at least one unsuccessful attempt at a weight loss program. The residence time for each balloon is variable with an average observed residence time of 15.3 weeks. The AGBS is to be used in conjunction with a moderate intensity lifestyle modification therapy program. The AGBS consists of up to two Allurion Balloons placed during a 10-month period.
Warrant Inducement
On February 24, 2026, Allurion Technologies, Inc. (the “Company”) entered into a warrant exercise inducement offer letter (the “Inducement Letter”) with certain holders (the “Exercising Holders”) of certain of the Company’s: (i) warrants issued in January 2025 to purchase shares of common stock, par value $0.0001 per share (“Common Stock”), with an exercise price of $6.00 per share (the “January 2025 Warrants”); (ii) warrants issued in February 2025 to purchase shares of Common Stock with an exercise price of $5.23 per share (the “February 2025 Warrants”); and (iii) warrants issued in November 2025 to purchase shares of Common Stock with an exercise price of $1.67 per share (the “November 2025 Warrants” and together with the January 2025 Warrants, February 2025 Warrants, the “Existing Warrants”).
Pursuant to the terms of the Inducement Letter, the Company agreed to amend the Existing Warrants by lowering the exercise price of the Existing Warrants to $1.15 per share. Additionally, the Exercising Holders agreed to exercise for cash certain of their Existing Warrants to purchase an aggregate of 2,659,565 shares of Common Stock in exchange for the Company’s agreement to issue to such Exercising Holder new warrants (the “New Warrants”) to purchase up to an aggregate of 5,319,130 shares of Common Stock. The Company received aggregate gross proceeds of approximately $3.1 million from the exercise of the Existing Warrants by the Exercising Holders.
Each New Warrant is exercisable into shares of Common Stock at a price per share of $1.15, will initially be exercisable following stockholder approval (the “Initial Exercise Date”), and will expire on the five-year anniversary of the Initial Exercise Date. Subject to limited exceptions, a holder of New Warrants will not have the right to exercise any portion of its New Warrants if the holder (together with such holder’s affiliates, and any persons acting as a group together with such holder or any of such holder’s affiliates) would beneficially own a number of shares of Common Stock in excess of 4.99% (or 9.99% at the Existing Holders’ option).
The Company has engaged Roth Capital Partners, LLC (“Roth”) as its financial advisor in connection with these transactions and will pay Roth a fee equal to 5.0% of its gross proceeds from the exercise of the Existing Warrants. The Company also agreed to pay Roth up to $40,000 for fees and expenses of legal counsel and other out-of-pocket expenses.
NYSE Continued Listing Standards
On March 2, 2026, the Company announced that it received a letter (the “Delisting Notice”) from the staff of the NYSE indicating that the Company does not meet certain of the NYSE's continued listing standards as set forth in the Minimum Market Capitalization Standard. The Company has a right to a review of this determination by a Committee of the Board of Directors of the Exchange (the “Committee”). The Company has appealed this delisting determination.
On March 6, 2026, the NYSE notified the Company that it has determined to commence proceedings to delist the Company’s Common Stock, and warrants to purchase 0.056818 shares of Common Stock, with an exercise price of $202.50 per share of Common Stock, as a result of the Company’s non-compliance with Rule 802.01B of the NYSE Listed Company Manual that requires listing companies to maintain an average global market capitalization of at least $15 million over a period of 30 consecutive trading days. Trading in the Common Stock on the NYSE was suspended after market close on March 6, 2026. The Company has appealed this delisting determination. If the Company is unsuccessful in its appeal, the Company expects the NYSE will file a Form 25 with the SEC, which would result in the delisting of the Company’s Common Stock and Warrants from the NYSE on the tenth day after the Form 25 is filed.
As a result of the suspension in trading and delisting process pending the Company’s appeal, the Common Stock is trading on the OTCID Market. The Company intends to apply to list on a higher-tier market operated by the OTC Market Group, Inc. under its current symbols "ALUR" and “ALUR WS”.
Resumption of Sales in France
On February 13, 2025, we announced that we are relaunching the Allurion Balloon in France after the Agence Nationale de Sécurité du Médicament (“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, effective immediately.
We derive revenue from the sale of the Allurion BalloonSmart Capsule to customers, which are either distributors or health care providers. The Allurion BalloonSmart Capsule 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.
The change in fair value of Revenue Interest Financing and PIPE Conversion Option (as defined below) 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 10,9, Fair Value Measurements for further information.
Termination of convertible note side letters
The termination of convertible note side letters consists of the expense recognized related to the convertible note prepayment penalty and recognition of the PubCo Share, Base PubCo Share and Backstop Share liabilities.
The loss on extinguishment of debt consists of the expenseloss recognized related toupon the extinguishmenttermination of our 2021term loan facility with Fortress Credit Corp. (the "Fortress Term Loan") and FortressRTW TermConvertible Loan.Notes.
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 associatedrecognized withupon ourthe Successmark Feeto derivativemarket of the Share Obligation liability and(as Fortressdefined Termin LoanNote derivative7, liability.Debt, in the accompanying notes to the consolidated financial statements). See Note 10,9, Fair Value Measurements, for further information.
Revenue decreased $16.9 million, or 53%, to $15.2 million for the year ended December 31, 2025, compared to the same period in 2024. The decrease in revenue was primarily the result of lower investment in sales and marketing as we move our strategy to "business to business to customer" and away from direct to customer, distributor transitions initiated in the second quarter of 2025, 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.
Revenue decreased $21.4 million, or 40%, to $32.1 million for the year ended December 31, 2024, compared to the same period in 2023. The decrease in revenue was the result of lower re-order rates as distributors and certain accounts adjusted their inventory levels, as well as macroeconomic headwinds in certain markets. Additionally, in August 2024, ANSM suspended sales of the Allurion Balloon in France, resulting in a $1.2 million reduction to revenue for customer returns of the Allurion Balloon as well as no further sales to France in the second half of 2024. The decrease in revenue was also attributable to selling less or no product to certain distributors and accounts to manage our credit risk.
Gross profit decreased $20.0$11.9 million, or 48%,55%, to $21.5$9.6 million for the year ended December 31, 2024,2025, compared to the same period in 2023.2024. The decrease in gross profit was primarily the result of an increase in our manufacturing expense, as less labor and overhead was absorbed due to lower production volumes, an increase in our excess and obsolete inventory reserve associated with expired inventory due to a drop in demand, as well as a decrease in revenue and sales volume of our gastric balloon system.system Additionally,coupled inwith Augustlower 2024,production ANSM suspended sales of the Allurion Balloon in France, resulting in a $1.2 million reduction to revenue for customer returns of the Allurion Balloon, as well as no further sales to France in the second half of 2024.volume.
Sales and marketing expenses decreased $20.9$15.1 million, or 45%,58%, to $25.9$10.8 million for the year ended December 31, 2024,2025, compared to the same period in 2023.2024. The decrease in sales and marketing expenses was primarily the result of a $14.0$9.9 million decrease attributable to salaries and related benefit costs due to a lower headcount, $3.8 million decrease in marketing spend driven by a reorganization of our selling and marketing spend focusing on more efficient channels and geographies, a $3.2$0.5 million decrease in outside consulting costs, a $0.4 million decrease in shipping and logistics expenses, a $1.2 million decrease in meeting expenses, a $1.1$0.3 million decrease in travel expenses, a $0.5 million decrease attributable to salaries and related benefit costs due to lower headcount, and a $0.5$0.2 million decrease in outsidefacilities consulting costs.expense. We expect sales and marketing costs to decrease in 20252026 as we have implemented cost reduction initiatives, including a reduction in force,force in Q3 2025, and shifthave shifted our focus of selling and marketing spend on more efficient channels and geographies.
Research and development expenses decreased $10.3$9.8 million, or 37%,56%, to $17.4$7.6 million for the year ended December 31, 2024,2025, compared to the same period in 2023.2024. The decrease in research and development expenses was the result of a decrease of $6.3$4.7 million in costs related to the AUDACITY clinical trial as itthe nearsfourth completion,and final module of the PMA was submitted to the FDA in June 2025 and we received FDA approval in February 2026, a $2.9$2.7 million decrease attributable to salaries and related benefit costs due to lower headcount, anda reduction of $1.7 million of procedure reimbursement costs, a $1.2$0.4 million decrease in outside consulting costs.costs, and a $0.2 million decrease in travel expenses. We expect research and development expenses to decrease in 20252026 as our AUDACITY trial nearsis completion,completed and we received FDA approval in February 2026, as well as cost reduction initiatives, including a reduction in force.force in Q3 2025.
General and administrative expenses decreased $17.6$7.0 million, or 38%,25%, to $28.4$21.4 million for the year ended December 31, 2024,2025, compared to the same period in 2023.2024. The decrease in general and administrative expenses was primarily the result of a $11.2$4.3 million decrease in badlegal debtand expense,professional fees of which $2.3 million can be attributed to one time financing fees in 2024, a $5.4$3.4 million decrease in stock-basedsalaries compensationand asrelated thebenefits prior period included a $4.9 million one-time chargecosts as a result of the Businessreduction Combination,in headcount, a $3.0$0.4 million reduction in IT expenses, a $0.4 million reduction in insurance expense, and a $0.1 million decrease in insurancestock expensebased ascompensation the prior period consisted of a $3.6 million one-time insurance charge related to the Business Combination, partially offset by an increase in director and officer insurance in the current year.expense. These decreases were partially offset by a $2.8$1.4 million increase in professional,bad legal,debt and consulting fees, driven by $1.4 million of one-time legal fees in connection with the Amended Note Purchase Agreement with RTW and $0.9 million of offering costs expensed as part of the July 2024 Public Offering and July 2024 Private Placement.expense. We expect general and administrative expenses to decrease in 2025,2026, as we have implemented cost reduction initiatives, including a reduction in force.force in Q3 2025.
Interest expense decreased $8.3$2.3 million, or 79%,100%, to $2.3 millionzero for the year ended December 31, 2024,2025, compared to the same period in 2023.2024. The decrease in interest expense was due the termination of our Fortress Term Loan in April 2024, as well as a reduction in principal of our Fortress Term Loan as compared to our 2021 Term Loan during the comparable twelve month period.2024.
The $17.0$12.8 million gain attributable to the change in fair value of warrants for the year ended December 31, 2024,2025, compared to the $17.0 million gain for the same period in 2023,2024, was due to mark to market fluctuations in our warrant liabilities due to the decline in value of our common stock during the periods, as well as the issuance of the July 2024 Public Offering Warrants and July 2024 Private Placement Warrants on July 1, 2024, for which there were no comparable mark to market fluctuations in the prior period.periods.
The $8.7$3.6 million gainloss attributable to the change in fair value of debt for the year ended December 31, 2024,2025, compared to the $18.1 million gain for the same period in 2023,2024, was due to mark to market fluctuations in our convertible debt.
The $14.3$9.1 million loss attributable to the change in fair value of the Revenue Interest Financing and PIPE Conversion Option for the year ended December 31, 2024,2025, compared to the $4.8 million loss for the same period in 2023,2024, was primarily due to a $13.1 million loss relatedmark to themarket changefluctuations in fair value of theour Revenue Interest Financing andduring athe $1.8 million loss on PIPE Conversion Option primarilyperiod driven by a decrease in the discount rate.
The $22.9$1.1 million gain attributable to the change in the fair value of earn-out liabilities for the year ended December 31, 20242025, compared to the $22.9 million gain for the same period in 2024, was due to the decreasefluctuations in our stock price from December 31, 20232024 to December 31, 2024.2025.
Termination of Convertible Note Side Letters
Termination of convertible note side letters increased from a loss of $17.6 million, or 100%, to zero for the year ended December 31, 2024, compared to the same period in 2023. The decrease was primarily due to changes in the PubCo Share, Base PubCo Share and Backstop Share liabilities driven by the use of the full backstop during the comparable periods for which there were no comparable liabilities in the current period.
What changed in the latest 10-Q
Risk Factors
Information regarding risk factors appears in Part I, Item 1A. "Risk Factors" of our Annual Report on Form 10-K. There have been no material changes from the risk factors previously disclosed in such 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.
Removed heading “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.”
Removed heading “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.”
Largest changes
“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.”see in full comparison
“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.”see in full comparison
“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. …”see in full comparison
“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.”see in full comparison
“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. …”see in full comparison
“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. …”see in full comparison
Full comparison: every changed paragraph (7)
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, thereThere have not been anyno material changes from the risk factors setpreviously forthdisclosed in oursuch 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 and this Quarterly Report on Form 10-Q,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 Internal Revenue Code, 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 United States 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 United States 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.
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.
Management's Discussion & Analysis (MD&A)
New heading “NYSE Continued Listing Standards”
New heading “Other Income, net”
New heading “Warrant Inducement Expense”
New heading “July 2024 Public Offering and Concurrent Private Placement”
New heading “Three Months Ended March 31, 2025”
Removed heading “Omnibus Amendment”
Removed heading “Second Amendment to Note Purchase Agreement”
Removed heading “Submission of Fourth and Final Module of Pre-Market Approval Application”
Removed heading “Strategic Restructuring and Reduction in Force”
Removed heading “November 2025 Securities Purchase Agreement”
Removed heading “Exchange Agreement”
Removed heading “Interest Expense”
Removed heading “Interest Expense”
Removed heading “Public Offering and Concurrent Private Placement”
Largest changes
“Strategic Restructuring and Reduction in Force”see in full comparison
“On March 6, 2026, the NYSE subsequently informed the Company that it has determined to commence proceedings to delist the Company’s Common Stock, and warrants to purchase 0.056818 shares of Common Stock, with an exercise price of $202.50 per share of Common Stock, as a result of the Company’s non-compliance with Rule 802.01B of the NYSE Listed Company Manual that requires listing companies to maintain an average global market capitalization of at least $15 million over a period of 30 consecutive trading days. …”see in full comparison
“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. …”see in full comparison
“As a result of the suspension in trading and delisting process, and pending the Company’s appeal, the Common Stock is trading on the OTCQB Market. The Company may apply to list on a higher-tier market operated by the OTC Market Group, Inc. under its current symbols "ALUR" and “ALUR.WS”.”see in full comparison
“On March 2, 2026, Company announced that it received a letter (the “Delisting Notice”) from the staff of the NYSE indicating that the Company does not meet certain of the NYSE's continued listing standards as set forth in the Minimum Market Capitalization Standard.”see in full comparison
“Submission of Fourth and Final Module of Pre-Market Approval Application”see in full comparison
Full comparison: every changed paragraph (137)
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 nine months ended SeptemberMarch 30,31, 20252026 and SeptemberMarch 30,31, 20242025 included in this Quarterly Report on Form 10-Q, and the audited consolidated financial statements as of and for the years ended December 31, 2025 and December 31, 2024 that are included in our Annual Report on Form 10-K filed with the SEC on March 27,30, 2025 as amended by Amendment No. 1 to the Annual Report on Form 10-K filed with the SEC on August 19, 20252026 (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. Capitalized terms not defined in this Management’s Discussion and Analysis of Financial Condition and Results of Operations section have the meanings ascribed to them in the condensed consolidated financial statements and the notes thereto included in this Quarterly Report on Form 10-Q.
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, procedure-lessProcedureless™ intragastric balloon for weight loss (the "Allurion Smart Capsule") 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 iswas 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.
For Allurion Program patients: Every current Allurion Program patient receives an Allurion Connected Scale ("Allurion Connected Scale") and access to our mobile app (the "App"), which integrates data from the Allurion Connected Scale to conveniently monitor weight, muscle mass, body fat, activity, sleep, and several other critical metrics. The App can also enable secure messaging and video telehealth with the patient’s care team and can deliver content from Allurion’s proprietary behavior change program—a - and library of 100 weight loss actions related to diet, nutrition, exercise, mental health, sleep, goal setting, and a number of other topics— - directly to the patient. The App is available in 15 languages.
In addition to its use by Allurion Smart Capsule patients, we believe the Allurion 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, we 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 the United States, Europe, the Middle East, Africa, Latin America, Canada and the Asia-Pacific region. We have submitted our premarket application for approval by the U.S. Food and Drug Administration ("FDA") for sale of our Allurion Program in the United States.
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 $11.6$2.9 million and $26.5$5.6 million for the ninethree months ended SeptemberMarch 30,31, 20252026 and 2024,2025, respectively, and incurred alosses netfrom lossoperations of $22.7$3.7 million and net income of $2.4$7.3 million for those same periods, respectively. We expect to continue to incur netoperating 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 subsectionssubsection titledentitled — “Liquidity and Capital Resources” and “Recent Developments” below.
FDA Approval
On February 20, 2026, the U.S. Food and Drug Administration (“FDA”) granted PMA approval for the Allurion Gastric Balloon System (AGBS), featuring the Allurion Smart Capsule. In the United States, the AGBS is indicated to promote short-term limited weight loss in adult individuals with obesity between the ages of 22 years and 65 years with a body mass index (BMI) ≥ 30 kg/m2 and ≤ 40 kg/m2 who have had at least one unsuccessful attempt at a weight loss program. The residence time for each balloon is variable with an average observed residence time of 15.3 weeks. The AGBS is to be used in conjunction with a moderate intensity lifestyle modification therapy program. The AGBS consists of up to two Allurion Balloons placed during a 10-month period.
On February 24, 2026, Allurion Technologies, Inc. (the “Company”) entered into a warrant exercise inducement offer letter (the “Inducement Letter”) with certain holders (the “Exercising Holders”) of certain of the Company’s: (i) warrants issued in January 2025 to purchase shares of common stock, par value $0.0001 per share (“Common Stock”), with an exercise price of $6.00 per share (the “January 2025 Warrants”); (ii) warrants issued in February 2025 to purchase shares of Common Stock with an exercise price of $5.23 per share (the “February 2025 Warrants”); and (iii) warrants issued in November 2025 to purchase shares of Common Stock with an exercise price of $1.67 per share (the “November 2025 Warrants” and together with the January 2025 Warrants, February 2025 Warrants, the “Existing Warrants”).
Pursuant to the terms of the Inducement Letter, the Company agreed to amend the Existing Warrants by lowering the exercise price of the Existing Warrants to $1.15 per share. Additionally, the Exercising Holders agreed to exercise for cash certain of their Existing Warrants to purchase an aggregate of 2,659,565 shares of Common Stock in exchange for the Company’s agreement to issue to such Exercising Holder new warrants (the “New Warrants”) to purchase up to an aggregate of 5,319,130 shares of Common Stock. The Company received aggregate gross proceeds of approximately $3.1 million from the exercise of the Existing Warrants by the Exercising Holders.
Each New Warrant is exercisable into shares of Common Stock at a price per share of $1.15, will initially be exercisable following stockholder approval (the “Initial Exercise Date”), and will expire on the five-year anniversary of the Initial Exercise Date. Subject to limited exceptions, a holder of New Warrants will not have the right to exercise any portion of its New Warrants if the holder (together with such holder’s affiliates, and any persons acting as a group together with such holder or any of such holder’s affiliates) would beneficially own a number of shares of Common Stock in excess of 4.99% (or 9.99% at the Existing Holders’ option).
The Company has engaged Roth Capital Partners, LLC (“Roth”) as its financial advisor in connection with these transactions and will pay Roth a fee equal to 5.0% of its gross proceeds from the exercise of the Existing Warrants. The Company also agreed to pay Roth up to $40,000 for fees and expenses of legal counsel and other out-of-pocket expenses.
NYSE Continued Listing Standards
On March 2, 2026, Company announced that it received a letter (the “Delisting Notice”) from the staff of the NYSE indicating that the Company does not meet certain of the NYSE's continued listing standards as set forth in the Minimum Market Capitalization Standard.
On March 6, 2026, the NYSE subsequently informed the Company that it has determined to commence proceedings to delist the Company’s Common Stock, and warrants to purchase 0.056818 shares of Common Stock, with an exercise price of $202.50 per share of Common Stock, as a result of the Company’s non-compliance with Rule 802.01B of the NYSE Listed Company Manual that requires listing companies to maintain an average global market capitalization of at least $15 million over a period of 30 consecutive trading days. Trading in the Common Stock on the NYSE was suspended after market close on March 6, 2026. The Company has appealed this delisting determination. If the Company is unsuccessful in its appeal, the Company expects the NYSE will file a Form 25 with the SEC, which would result in the delisting of the Company’s Common Stock and Warrants from the NYSE on the tenth day after the Form 25 is filed.
As a result of the suspension in trading and delisting process, and pending the Company’s appeal, the Common Stock is trading on the OTCQB Market. The Company may apply to list on a higher-tier market operated by the OTC Market Group, Inc. under its current symbols "ALUR" and “ALUR.WS”.
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, (ii) 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 (iii) 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 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.
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”). On November 4, 2025, the Purchasers provided notice of conversion of $5.0 million of principal amount of the RTW Convertible Notes at the Floor Conversion Rate, for an aggregate of 1,492,539 shares of Common Stock, which notice was accepted by us on November 5, 2025.
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 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:
We signed a term sheet with a strategic partner to expand ex-US distribution and enhance the R&D pipeline, including the potential joint development of a novel, GLP-1 drug-eluting intragastric balloon.
We submitted our protocol for a prospective, multi-center study on the combination of the Allurion Program with a low-dose of GLP-1 for weight loss while maintaining muscle mass and increasing GLP-1 adherence to Institutional Review Boards (“IRBs”) in Europe for approval, and expect to begin enrollment for such study this year.
We commenced a transition to distribution partners with access to physician networks prescribing GLP-1s and equipped with teams and infrastructure to deliver metabolically healthy weight loss.
The Restructuring Plan includes a reduction in force of approximately 70 employees, or approximately 65% of our workforce, which is substantially complete. As part of this Restructuring Plan, we expect to incur severance and severance-related charges of approximately $1.5 million. Our estimated restructuring charges are 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.
November 2025 Securities Purchase Agreement
On November 11, 2025, we entered into a securities purchase agreement (the "November 2025 Securities Purchase Agreement") with certain accredited investors named therein, pursuant to which we agreed to issue and sell 2,994,012 shares of our Common Stock and accompanying common warrants to purchase up to 2,994,012 shares of Common Stock (the "November 2025 Private Placement Warrants"), for an aggregate purchase price of approximately $5.0 million at a purchase price of $1.67 per share and accompanying November 2025 Private Placement Warrant.
Exchange Agreement
On November 11, 2025, we entered into a securities purchase and exchange agreement (the "Exchange Agreement") with certain entities managed by RTW, pursuant to which RTW has agreed to exchange all of the (i) principal amount of convertible senior secured notes (the "Notes"), purchased pursuant to the terms of the Amended Note Purchase Agreement, including interest accrued on the Notes; (ii) Company obligations under the Revenue Interest Financing Agreement; and (iii) Company obligations under the New RIFA (together with the Revenue Interest Financing Agreement, the "RIFAs") for shares of a newly issued class of Series B convertible preferred stock, par value $0.0001 per share ("Series B Preferred Stock") of the Company (the "Exchange"). RTW's obligation to consummate the closing of the Exchange is conditioned upon, among other things, the receipt of stockholder approval of the issuance of Series B Preferred Stock no later than January 31, 2026. The terms of the Series B Preferred Stock are described in our Current Report on Form 8-K, filed with the SEC on November 12, 2025.
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 this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K.
Regulatory approval and timing and efficiency of new product introductions. We must successfully obtain timely approvals, maintain regulatory approval, successfully implement any remediation programs required by regulators to resume sales of the Allurion Smart Capsule,Balloon, and introduce new products that gain acceptance with health care providers. For our sales to grow, we will also need to obtain regulatory approval of our existing product and any new products or modifications/enhancements to our existing products in the markets that we operate in and new markets as applicable.
Product and geographic mix; timing. Our financial results, including our gross margins, may fluctuate from period to period based on the timing of orders, fluctuations in foreign currency exchange ratesrates, and the number of available selling days in a particular period, which can be impacted by a number of factors, such as holidays or days of severe inclement weather in a particular geography, the mix of products soldsold, and the geographic mix of where products are sold.
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 activitiesactivities, and shipping costs.
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 equipmentequipment, and other outside services.
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 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.RTW. See Note 10,9, Fair Value Measurements for further information.
The loss on extinguishment of debt consists of the loss recognized upon the termination of our term loan facility with Fortress Credit Corp. (the "Fortress Term Loan") and RTW Convertible Notes.
OtherWarrant IncomeInducement (Expense), net
Warrant inducement expense consists of the gain or loss recognized upon the Warrant Inducement and issuance of Inducement Warrants. See Note 11, Capital Stock and Stockholders Deficit for further information.
Other Income, 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 associatedrecognized withupon ourthe mark to market of the Share Obligation liability (as defined in Note 8,7, Debt, in the accompanying notes to the condensed consolidated financial statements). See Note 10,9, Fair Value Measurements, for further information.
Comparison of the Three and Nine Months Ended SeptemberMarch 30,31, 20252026 and 20242025 (unaudited)
The following table summarizes our results of operations for the three and nine months ended SeptemberMarch 30,31, 20252026 and 20242025 (in thousands):
ALUR insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-07-21 | Rtw Investments, Lp |
Other | 19,934 | — | — |
| 2026-07-21 | Rtw Investments, Lp |
Other | 209,254 | — | — |
| 2026-07-21 | Rtw Investments, Lp |
Other | 161,807 | — | — |
| 2026-07-21 | Rtw Investments, Lp |
Other | 1,771 | — | — |
Well-known investors holding ALUR (13F)
None of the 59 investors we track reported a position in their latest 13F.