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What changed in Inogen Inc's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Inogen Inc's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+445 added−428 removedSource: 10-K (2026-02-27) vs 10-K (2025-02-28)

Top changes in Inogen Inc's 2025 10-K

445 paragraphs added · 428 removed · 373 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

148 edited+32 added−15 removed91 unchanged
Biggest changeHIPAA The Health Insurance Portability and Accountability Act of 1996, or HIPAA, established uniform standards governing the conduct of certain electronic healthcare transactions and protecting the security and privacy of individually identifiable health information maintained or transmitted by most healthcare providers, health plans and healthcare clearinghouses, which are referred to as “covered entities.” Among the standards that have been promulgated under HIPAA’s regulations: the Standards for Privacy of Individually Identifiable Health Information, which restrict the use and disclosure of certain individually identifiable health information, the Standards for Electronic Transactions, which establish standards for common healthcare transactions, such as claims information, plan eligibility, payment information and the use of electronic signatures, the Security Standards, which require covered entities to implement and maintain certain security measures to safeguard certain electronic health information, including the adoption of administrative, physical and technical safeguards to protect such information, and the Breach Notification Standards, which establish standards for notification in the event of a breach of unsecured individually identifiable health information. 13 In 2009, Congress passed the American Recovery and Reinvestment Act of 2009, or ARRA, which included sweeping changes to HIPAA, including an expansion of HIPAA’s privacy and security standards.
Biggest changeHIPAA The Health Insurance Portability and Accountability Act of 1996, or HIPAA, established uniform standards governing certain electronic healthcare transactions and the privacy and security of individually identifiable health information maintained or transmitted by healthcare providers, health plans, and healthcare clearinghouses, known as “covered entities.” Regulations promulgated under HIPAA include standards governing the use and disclosure of protected health information, requirements for electronic healthcare transactions such as claims, eligibility, and payment information, security standards requiring administrative, physical, and technical safeguards to protect electronic health information, and breach notification requirements applicable in the event of unauthorized access to unsecured protected health information.
We webcast our earnings calls and certain events we participate in or host with members of the investment community on our investor relations page of our website. In addition, we use our website http://investor.inogen.com as a means of disclosing information about our company, our products, our planned financial and other announcements, our attendance at upcoming investor conferences, and other matters.
We webcast our earnings calls and certain events we participate in or host with members of the investment community on our investor relations page on our website. In addition, we use our website http://investor.inogen.com as a means of disclosing information about our company, our products, our planned financial and other announcements, our attendance at upcoming investor conferences, and other matters.
We receive no additional reimbursement for patient support, but we provide high-quality customer service to enhance patient comfort, satisfaction, and safety with our products. Third-party reimbursement As a provider of home oxygen, Inogen participates in the Medicare Part B, Supplementary Medical Insurance Program, which was established by the Social Security Act of 1965.
We receive no additional reimbursement for patient support, but we provide high-quality customer service to enhance patient comfort, satisfaction, and safety with our products. 7 Third-party reimbursement As a provider of home oxygen, Inogen participates in the Medicare Part B, Supplementary Medical Insurance Program, which was established by the Social Security Act of 1965.
Also, in support of our European operations, we produce our Inogen Rove 6 concentrators and perform related repair activities using a contract manufacturer, Foxconn, located in the Czech Republic to improve our ability to efficiently service our European customers. Physio-Assist sells its Simeox product throughout Europe and several other markets and manufactures the product in its Montpelier, France location.
Also, in support of our European operations, we produce our Inogen Rove 6 concentrators and perform related repair activities using a contract manufacturer, Foxconn, located in the Czech Republic to improve our ability to efficiently service our European customers. Physio-Assist sells our Simeox product throughout Europe and several other markets and manufactures the product in our Montpelier, France location.
Additionally, an independent internal review is performed, and our products are not deployed until after physician paperwork is processed and reimbursement eligibility is verified and communicated to the patient. 7 We have contracts with Medicaid, Medicare Advantage, government and private payors that qualify us as an in-network provider for these payors.
Additionally, an independent internal review is performed, and our products are not deployed until after physician paperwork is processed and reimbursement eligibility is verified and communicated to the patient. We have contracts with Medicaid, Medicare Advantage, government, and private payors that qualify us as an in-network provider for these payors.
We have sponsored clinical studies and real-world data analyses that recently resulted in several publications in the areas of the following: use of POCs, impact of oxygen treatment modality and patient mobility on mortality and healthcare resource utilization, as well as the impact of ventilatory support in addition to oxygen therapy on exercise tolerance in patients with COPD.
We have sponsored clinical studies and real-world data analyses that have resulted in several publications in the following areas: use of POCs, impact of oxygen treatment modality and patient mobility on mortality and healthcare resource utilization, as well as the impact of ventilatory support in addition to oxygen therapy on exercise tolerance in patients with COPD.
Our proprietary Inogen One ® and Inogen Rove ® systems concentrate the air around the patient to offer a source of supplemental oxygen 24 hours a day, seven days a week with a battery and can be plugged into an outlet when at home, in a car, or in a public place with outlets available.
Our proprietary Inogen One ® and Inogen Rove ® POC systems concentrate the air around the patient to offer a source of supplemental oxygen 24 hours a day, seven days a week with a battery and can be plugged into an outlet when at home, in a car, or in a public place with outlets available.
Simeox has been commercialized in Europe and several other markets for several years and was recently cleared by the FDA for use in the United States in December 2024. Simeox uses an innovative technology of oscillating negative pressure to liquify mucus in the bronchi and help patients evacuate it by coughing and/or leveraging postural drainage.
Simeox has been commercialized in Europe and several other markets for several years and was cleared by the FDA for use in the United States in December 2024. Simeox uses an innovative technology of oscillating negative pressure to liquify mucus in the bronchi and help patients evacuate it by coughing and/or leveraging postural drainage.
We have modified various aspects of our Inogen One systems since receiving regulatory clearance, but we believe that new 510(k) clearances are not required for these modifications. If the FDA disagrees with our determination not to seek a new 510(k) clearance, the FDA may retroactively require us to seek 510(k) clearance or pre-market approval.
We have modified various aspects of our Inogen systems since receiving regulatory clearance, but we believe that new 510(k) clearances are not required for these modifications. If the FDA disagrees with our determination not to seek a new 510(k) clearance, the FDA may retroactively require us to seek 510(k) clearance or pre-market approval.
These customers market the benefits of our products to oxygen therapy patients through consumer advertising and/or retail locations or to physicians through field-based prescriber sales representatives. We believe that in addition to the marketing efforts employed by our business customers, our own direct-to-consumer marketing efforts in the United States result in patient interest that our business customers field.
These customers market the benefits of our products to oxygen therapy patients through consumer advertising and/or retail locations or to physicians through field-based prescriber sales representatives. 6 We believe that in addition to the marketing efforts employed by our business customers, our own direct-to-consumer marketing efforts in the United States result in patient interest that our business customers field.
None of our employees are represented by a collective bargaining agreement and we believe that our employee relations are good. 16 Employee culture Inogen strives to instill a culture based on our foundational values of (1) We always do what is right, (2) Invest in people, and (3) Treat people right.
None of our employees are represented by a collective bargaining agreement and we believe that our employee relations are good. Employee culture Inogen strives to instill a culture based on our foundational values of (1) We always do what is right, (2) Invest in people, and (3) Treat people right.
Manufacturing and raw materials We have been developing and refining the manufacturing of our oxygen concentrator systems since 2004. While nearly all of our manufacturing and assembly processes were originally outsourced, assembly of the compressors, sieve beds, and concentrators were brought in-house in order to improve quality control and reduce cost.
Manufacturing and raw materials We have been developing and refining the manufacturing of our oxygen concentrator systems since 2004. While nearly all of our manufacturing and assembly processes were originally outsourced, assembly of the compressors, sieve beds, and concentrators were brought in-house to improve quality control and reduce cost.
De Novo authorization is intended as a potential pathway for devices for which the 510(k) process is not an available pathway because there is no legally marketed predicate device to which to claim substantial equivalence.
De Novo authorization is intended as a potential pathway for devices for which the 510(k) process is not an available pathway because there is no legally marketed predicate device on which to claim substantial equivalence.
Pre-market approval pathway A pre-market approval application must be submitted to the FDA if the device cannot be cleared or authorized through the 510(k) or De Novo process. The pre-market approval application process is more demanding than the 510(k) pre-market notification process.
Pre-market approval pathway A pre-market approval application must be submitted to the FDA if the device cannot be cleared or authorized through the 510(k) or De Novo process. The PMA process is more demanding than the 510(k) pre-market notification process.
We believe that any policy to regulate GHG emissions should fairly account for companies that have already taken voluntary steps to reduce their GHG emissions. Inogen is a responsible corporate citizen that has done business in 65 countries and territories around the world. Our business success and our environmental stewardship both depend on the efficiency of our global distribution network.
We believe that any policy to regulate GHG emissions should fairly account for companies that have already taken voluntary steps to reduce their GHG emissions. Inogen is a responsible corporate citizen that has done business in 70 countries and territories around the world. Our business success and our environmental stewardship both depend on the efficiency of our global distribution network.
To date, we have sold our products in a total of 65 countries outside the United States through distributors or directly to large “house” accounts, which include gas companies and home oxygen providers. For international sales, we sell to and bill the distributor or house accounts directly, leaving the patient billing, support, and clinical setup to the local provider.
To date, we have sold our products in a total of 70 countries outside the United States through distributors or directly to large “house” accounts, which include gas companies and home oxygen providers. For international sales, we sell to and bill the distributor or house accounts directly, leaving the patient billing, support, and clinical setup to the local provider.
In certain cases, these agreements can be terminated by either party upon relatively short notice. We expect to maintain our assembly operations for our products at our facility in Plano, Texas. We also manufacture the Simeox device in a leased facility in Montpelier, France. We use lean manufacturing practices to maximize manufacturing efficiency and eliminate waste.
In certain cases, these agreements can be terminated by either party upon relatively short notice. We expect to maintain our assembly operations for our products at our facility in Plano, Texas. We also manufacture the Simeox device in a leased facility in Montpelier, France. We use lean manufacturing practices to maximize manufacturing efficiency and reduce waste.
By law, FDA is supposed to make a decision on a 510(k) within 90 calendar days of accepting the submission for review; however, as a practical matter, clearance often takes significantly longer. The FDA must accept the submission for substantive review and may require further information, including clinical data, to make a determination regarding substantial equivalence.
By law, FDA is supposed to decide on a 510(k) within 90 calendar days of accepting the submission for review; however, as a practical matter, clearance often takes significantly longer. The FDA must accept the submission for substantive review and may require further information, including clinical data, to make a determination regarding substantial equivalence.
The market Chronic obstructive pulmonary disease We are focused on oxygen therapy and other opportunities in the global respiratory care market. We believe that our portable oxygen therapy solutions can help patients with chronic respiratory conditions, including patients with chronic obstructive pulmonary disease, or COPD. COPD is a group of lung diseases including chronic bronchitis and emphysema.
The market Chronic obstructive pulmonary disease We are focused on oxygen therapy and other opportunities in the global respiratory care market. We believe that our oxygen therapy solutions can help patients with chronic respiratory conditions, including patients with COPD. COPD is a group of lung diseases including chronic bronchitis and emphysema.
A particular advantage of this technology is that it can be used by patients capable of generating productive cough, regardless of the body size, chest wall abnormalities or back pains. The efficacy and safety of Simeox has been demonstrated in 10 clinical trials.
A particular advantage of this technology is that it can be used by patients capable of generating productive cough, regardless of the body size, chest wall abnormalities or back pains. The efficacy and safety of Simeox has been demonstrated in numerous clinical trials.
Government regulation Inogen's products, including the Inogen One and Rove systems, Inogen At Home systems, Simeox, and related accessories, are medical devices subject to extensive and ongoing regulation by the FDA, as well as other federal and state regulatory bodies in the United States and comparable authorities in other countries.
Government regulation Inogen's products, including the Inogen One and Rove systems, Inogen At Home systems, Simeox, Voxi, Aurora, and related accessories, are medical devices subject to extensive and ongoing regulation by the FDA, as well as other federal and state regulatory bodies in the United States and comparable authorities in other countries.
The FDA regulations govern the following activities that we perform, or that are performed on our behalf, to ensure that medical products distributed domestically or exported internationally are safe and effective for their intended uses: product design and development, pre-clinical and clinical testing, manufacturing, labeling, storage, pre-market clearance or approval, record keeping, product marketing, advertising and promotion, sales and distribution and post marketed safety reporting. 9 FDA’s classification of medical devices and pre-market clearance and approval requirements FDA classifies medical devices into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each medical device and the extent of control needed to ensure safety and effectiveness.
The FDA regulations govern the following activities that we perform, or that are performed on our behalf, to ensure that medical products distributed domestically or exported internationally are safe and effective for their intended uses: product design and development, pre-clinical and clinical testing, manufacturing, labeling, storage, pre-market clearance or approval, record keeping, product marketing, advertising and promotion, sales and distribution, and post marketed safety reporting. 9 FDA’s classification of medical devices and pre-market clearance and approval requirements FDA classifies medical devices into one of three classes—Class I, Class II, or Class III—depending on the degree of risk and the extent of control needed to ensure safety and effectiveness.
For many years, Lincare, Inc. (a subsidiary of the Linde Group), Apria Healthcare, Inc., AdaptHealth Corp., Rotech Healthcare, Inc., and Viemed Healthcare, Inc. have been among the market leaders in providing respiratory therapy products, while the remaining market is serviced by local providers.
For many years, Lincare, Inc. (a subsidiary of the Linde Group), Apria Healthcare, Inc., AdaptHealth Corp., Rotech Healthcare, Inc., and Viemed Healthcare, Inc. have been among the market leaders in providing respiratory therapy products, while the remaining market is serviced by local or regional providers.
Smith has served as our Executive Vice President, General Counsel, Secretary and Business Development since July 2024. Most recently, Mr. Smith served as General Counsel and Executive Vice President, Business Development of Sirtex Medical, a medical device company, from October 2018 to June 2024. In his prior roles, Mr.
Kevin P. Smith has served as our Executive Vice President, General Counsel, Secretary and Business Development since July 2024. Most recently, Mr. Smith served as General Counsel and Executive Vice President, Business Development of Sirtex Medical, a medical device company, from October 2018 to June 2024. In his prior roles, Mr.
While often used concomitantly with stationary oxygen concentrators and oxygen compressed gas tanks, our POCs are designed to reduce the patient’s reliance on stationary concentrators and scheduled deliveries of tanks with a finite supply of oxygen, thereby improving patient quality of life and fostering mobility.
While often used together with stationary oxygen concentrators and oxygen compressed gas tanks, our POCs are designed to reduce the patient’s reliance on stationary concentrators and scheduled deliveries of tanks with a finite supply of oxygen, thereby improving patient quality of life and fostering mobility.
As of December 31, 2024, we had a dedicated customer service team that was trained on our products, a clinical support team made up of licensed nurses or respiratory therapists, a patient intake team, an order intake team, and a dedicated billing services team.
As of December 31, 2025, we had a dedicated customer service team that was trained on our products, a clinical support team made up of licensed nurses or respiratory therapists, a patient intake team, an order intake team, and a dedicated billing services team.
Respiratory therapy providers compete primarily on the basis of product features and service, rather than price, since reimbursement levels are established by Medicare and Medicaid, or by the individual determinations of private payors.
Respiratory therapy providers compete primarily based on product features and service, rather than price, since reimbursement levels are established by Medicare and Medicaid, or by the individual determinations of private payors.
By measuring component performance, communicating daily with the production group and our suppliers, and reviewing customer complaints, our Quality Assurance department, through the use of our corrective action program, drives and documents continuous performance improvement of our suppliers and internal departments. Our Regulatory Affairs department also trains internal quality auditors to audit our adherence to the Quality Management system.
By measuring component performance, communicating daily with the production group and our suppliers, and reviewing customer complaints, our Quality Assurance department, using our corrective action program, drives and documents continuous performance improvement of our suppliers and internal departments. Our Regulatory Affairs department also trains internal quality auditors to audit our adherence to the Quality Management system.
Class III devices require FDA approval of a pre-market approval application, or PMA, demonstrating reasonable assurance of safety and effectiveness of the device, prior to commercial distribution. Class III devices are those deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices.
Class III devices require FDA's pre-market approval, or PMA, demonstrating reasonable assurance of safety and effectiveness of the device, prior to commercial distribution. Class III devices are those deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting, or implantable devices.
We believe the following factors have hindered the market acceptance of POCs: • to obtain POCs, many patients are dependent on home medical equipment providers, which may have significant investments in the physical distribution infrastructure to support the delivery model for stationary devices and therefore may be disincentivized to encourage adoption of POCs; • home medical equipment providers cannot easily convert their businesses to non-delivery models in oxygen due to low total reimbursement for oxygen therapy, capital expenditure constraints, investments that are spread across multiple product lines, and uncertainty around reimbursement rate changes; • due to the nature of the capped reimbursement structure, patients' lack of ability to use their insurance benefits to switch from oxygen tanks or liquid deliveries to POCs; and • constrained manufacturing costs of conventional POCs, driven by home medical equipment provider preference for products that have lower upfront equipment cost.
We believe that the adoption POCs by home medical equipment providers has progressed, although the following factors remain countervailing forces to the full market acceptance of POCs: • to obtain POCs, many patients are dependent on home medical equipment providers, which may have significant investments in the physical distribution infrastructure to support the delivery model for stationary devices and tanks, and therefore may be disincentivized to encourage adoption of POCs; • home medical equipment providers cannot easily convert their businesses to non-delivery models in oxygen due to low total reimbursement for oxygen therapy, capital expenditure constraints, investments that are spread across multiple product lines, and uncertainty around reimbursement rate changes; • due to the nature of the capped reimbursement structure, patients' lack of ability to use their insurance benefits to switch from oxygen tanks or liquid deliveries to POCs; and • constrained manufacturing costs of conventional POCs, driven by home medical equipment provider preference for products that have lower upfront equipment cost.
One example of a patent in this category is U.S. patent 9,907,926, which is directed to an oxygen concentrator for mechanical ventilation. This category of patents expires in 2023 or later (without taking into account any patent term adjustments).
One example of a patent in this category is U.S. patent 9,907,926, which is directed to an oxygen concentrator for mechanical ventilation. This category of patents generally expires in 2023 or later (without taking into account any patent term adjustments or terminal disclaimers).
We have also sponsored clinical studies on the Simeox device through Physio-Assist both prior to and since the acquisition. We continue to invest in clinical research activities to support new product development, as well as expansion of the uses of its products and services.
We have also sponsored clinical studies on the Simeox device through Physio-Assist both prior to and since the acquisition. We continue to invest in clinical research activities to support product development, as well as expansion of the uses of our products and services.
Our Quality Management system has been certified to ISO 13485:2016 by BSI, a notified body. In addition, we continue to operate the quality management system of Physio Assist as we move to fully integrate the systems, with its system also certified to ISO 13485:2016 by IMQ, its notified body.
Our Quality Management system has been certified to ISO 13485:2016 by BSI, a notified body. In addition, we continue to operate the quality management system of Physio Assist as we move to fully integrate the systems, which is also certified to ISO 13485:2016 by IMQ, its notified body.
For additional discussion of potential risks related to our manufacturing and raw materials, please see the risk factor entitled “ Reduction or interruption in our supply of components and products may adversely affect our manufacturing operations and related product sales." We currently manufacture our oxygen concentrators in a leased building in Plano, Texas and have a design facility at our Corporate Headquarters in Goleta, California, that we have registered with the Food and Drug Administration, or FDA, and maintain a Quality Management system for which we have obtained International Standards Organization, or ISO, 13485 certification.
For additional discussion of potential risks related to our manufacturing and raw materials, please see the risk factor entitled “ Reduction or interruption in our supply of components and products may adversely affect our manufacturing operations and related product sales.” We currently manufacture our oxygen concentrators in a leased building in Plano, Texas and have a design facility at our location in Goleta, California, that we have registered with the FDA and maintain a Quality Management system for which we have obtained International Standards Organization, or ISO, 13485 certification.
However, the strategies of these major competitors are currently limited to direct-to-consumer sales and do not include direct-to-consumer rentals where they would be responsible to meet national accreditation and state-by-state licensing requirements and secure Medicare billing privileges. Manufacturing companies compete for sales to providers primarily on the basis of price, quality/reliability, financing, bundling, product features, and service.
However, the strategies of these major competitors are currently limited to direct-to-consumer sales and do not include direct-to-consumer rentals where they would be responsible for meeting national accreditation and state-by-state licensing requirements and securing Medicare billing privileges. Manufacturing companies compete for sales to providers primarily on the basis of price, quality/reliability, financing, product features, and service.
In addition, the FDA will conduct a preapproval inspection of the manufacturing facility to ensure compliance with quality system regulations. 10 Clinical trials Clinical trials are almost always required to support pre-market approval and are sometimes required for 510(k) clearance and De Novo authorization.
In addition, the FDA will conduct a pre-approval inspection of the manufacturing facility to ensure compliance with quality system regulations. 10 Clinical trials Clinical trials are almost always required to support PMA devices, and are sometimes required for 510(k) clearance and De Novo authorization devices.
Other diseases including cystic fibrosis or congestive heart failure may lead to lower oxygen in the bloodstream and may also benefit from long-term oxygen therapy. 3 Oxygen therapy Inogen created its first POCs with a goal of creating products that allow patients the chance to remain ambulatory while managing the impact of their disease.
Other diseases including long term COVID-19 or congestive heart failure may lead to lower oxygen in the bloodstream and may also benefit from long-term oxygen therapy. Oxygen therapy Inogen created its first POCs with a goal of creating products that allow patients the chance to remain ambulatory while managing the impact of their disease.
Because of reimbursement reductions, we expect more industry consolidation and volatility in ordering patterns based on how providers are restructuring their businesses and their access to capital.
Because of actual and potential reimbursement restrictions and reductions, we expect more industry consolidation and volatility in ordering patterns based on how providers are restructuring their businesses and their access to capital.
In addition, providers may reduce or eliminate purchases from us due to our increased focus on building out a prescriber sales team and pursuing rentals directly, which could be in competition with our providers in the United States.
In addition, providers may reduce or eliminate purchases from us due to our focus on maintaining a prescriber sales team and pursuing rentals directly, which could be in competition with our providers in the United States.
A pre-market approval application must be supported by extensive data, generally including but not limited to, technical information, preclinical testing, clinical trials, manufacturing information, and labeling to demonstrate reasonable assurance of safety and effectiveness of the device.
A PMA application must be supported by extensive data, generally including but not limited to, technical information, preclinical testing, clinical trials, manufacturing information, and labeling to demonstrate reasonable assurance of safety and effectiveness of the device.
Our website address is www.inogen.com . We make available on our website, free of charge, our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and any amendments to those reports, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.
We make available on our website, free of charge, our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and any amendments to those reports, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.
Smith holds an MBA in Global Management from University of Phoenix and a B.S. in Marketing from the University of Kentucky. Michael Bourque has served as our Executive Vice President, Chief Financial Officer and Corporate Treasurer since March 2024. Most recently, Mr. Bourque served as Chief Financial Officer and Treasurer of Chase Corporation from February 2021 to February 2024.
Smith holds an MBA in Global Management from University of Phoenix and a B.S. in Marketing from the University of Kentucky. Michael Bourque has served as our Executive Vice President, Chief Financial Officer and Corporate Treasurer since March 2024. Most recently, Mr.
Ramade served as Senior Vice President and Chief Commercial Officer of Vapotherm, Inc. from October 2020 to October 2023 and as Vice President, International Sales and Worldwide Marketing of Vapotherm since May 2016. Mr.
Prior to joining the Company, Mr. Ramade served as Senior Vice President and Chief Commercial Officer of Vapotherm, Inc. from October 2020 to October 2023 and as Vice President, International Sales and Worldwide Marketing of Vapotherm since May 2016. Mr.
Accounts receivable balances relating to Medicare’s service reimbursement programs (including held and unbilled receivables, net of allowances) amounted to $1.1 million or 3.7% of total net accounts receivable as of December 31, 2024 compared to $2.1 million, or 4.9%, of total accounts receivable as of December 31, 2023.
Accounts receivable balances relating to Medicare’s service reimbursement programs (including held and unbilled receivables, net of allowances) amounted to $1.4 million, or 3.6%, of total net accounts receivable as of December 31, 2025, compared to $1.1 million, or 3.7%, of total net accounts receivable as of December 31, 2024.
These include: • establishment registration and device listing; • quality system regulations, which require device manufacturers to comply with both design control requirements and good manufacturing practice requirements (such as requirements for purchasing controls, document controls, production and process controls, labeling and packaging controls, control of nonconforming product, complaint handling, corrective and preventative actions, storage, handling, distribution, and servicing); • labeling regulations (including FDA's Unique Device Identification requirements), the FDA's prohibitions against the promotion of devices for un-cleared, unapproved or “off-label” uses, and other requirements related to promotional activities; • medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur; • corrections and removals reporting regulations, which require that manufacturers report to the FDA corrections and removals of distributed devices (including repairs, modifications, adjustments, relabeling, destruction, or inspection of a device without physical removal) if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; and • post-market surveillance regulations, which apply, upon FDA order, to certain devices to help address important public health questions regarding the safety and effectiveness of a device. 11 After a device receives 510(k) clearance or De Novo authorization, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, will require submission and clearance of a new 510(k).
These include: • establishment registration and device listing; • quality system regulations, which require device manufacturers to comply with both design control requirements and good manufacturing practice requirements (such as requirements for purchasing controls, document controls, production and process controls, labeling and packaging controls, control of nonconforming product, complaint handling, corrective and preventative actions, storage, handling, distribution, and servicing); • labeling regulations (including FDA's Unique Device Identification requirements), the FDA's prohibitions against the promotion of devices for un-cleared, unapproved or “off-label” uses, and other requirements related to promotional activities; • medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur; • corrections and removals reporting regulations, which require that manufacturers report to the FDA corrections and removals of distributed devices (including repairs, modifications, adjustments, relabeling, destruction, or inspection of a device without physical removal) if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; and • post-market surveillance regulations, which apply, upon FDA order, to certain devices to help address important public health questions regarding the safety and effectiveness of a device.
The Company is not aware of any pending claims against it under the False Claims Act. Civil monetary penalties law The Federal Civil Monetary Penalties Law grants authority to the U.S.
The Company is not aware of any pending claims against it under the False Claims Act. Civil monetary penalties law The Federal Civil Monetary Penalties Law authorizes the U.S.
These patents may prevent competitors from achieving the same levels of optimization as found in our products. A third category of patents and patent applications relates to system designs that may be directed to products in both oxygen and ventilation product categories.
These features and designs are developed to facilitate the design, manufacturing, and usefulness of our products. These patents may prevent competitors from achieving the same levels of optimization as found in our products. A third category of patents and patent applications relates to system designs that may be directed to products in both oxygen and ventilation product categories.
We have leveraged our 87 issued patents and intend to continue to seek ways to innovate to develop products and functionality improvements that enhance patient quality of life and to reduce costs through manufacturing and design improvements. Competition The long-term oxygen therapy market is a highly competitive industry.
We have leveraged our 96 issued patents and intend to continue to seek ways to innovate to develop products and functionality improvements that enhance patient quality of life and to reduce costs through manufacturing and design improvements. Competition The long-term oxygen therapy market, as well as the broader respiratory market, is highly competitive.
Internal communications and celebration are further proof points for our efforts as we routinely measure employee engagement in these categories. We maintain an equitable, market-based compensation architecture and proactively align our benefits, policies and practices with the philosophies, values, and culture pillars. Inclusive leadership programming and onboarding programs further support these efforts across the organization.
Internal communications and celebration are further proof points for our efforts as we routinely measure employee engagement in these categories. We maintain an equitable, market-based compensation architecture and proactively align our benefits, policies and practices with the philosophies, values, and culture pillars.
We also supply lower cost third-party manufactured stationary concentrators to our rental patients who require secondary sources of oxygen as a part of their CMS contract or to meet other clinical or payor requirements. Airway clearance We added Simeox, an airway clearance device, to our portfolio through the acquisition of Physio-Assist in September 2023.
We also supply the Voxi and other stationary concentrators to our rental patients who require secondary sources of oxygen as a part of their CMS contract or to meet other clinical or payor requirements. 5 Airway clearance devices We added Simeox, an airway clearance device, to our portfolio through the acquisition of Physio-Assist in September 2023.
Inogen is committed to compliance with all applicable federal and state laws prohibiting discrimination in employment and, therefore, does not discriminate against its employees or applicants based on any legally recognized “protected class.” We perform an annual affirmative action review by job role, and we have a process which identifies pay or promotion discrepancies and ensures that we are equitable in our actions and decisions.
Inclusive leadership programming and onboarding programs further support these efforts across the organization. 16 Inogen is committed to compliance with all applicable federal and state laws prohibiting discrimination in employment and, therefore, does not discriminate against its employees or applicants based on any legally recognized “protected class.” We perform an annual affirmative action review by job role, and we have a process which identifies pay or promotion discrepancies and ensures that we are equitable in our actions and decisions.
For example, we historically experienced higher sales revenue in the second and third quarters, as a result of consumers traveling and vacationing during warmer weather in the spring and summer months, but this may vary year-over-year.
Seasonality We believe our sales may be impacted by seasonal factors. For example, we historically experienced higher sales revenue in the second and third quarters, as a result of consumers traveling and vacationing during warmer weather in the spring and summer months, but this may vary year-over-year.
As of December 31, 2024, we employed 356 people in the United States and Europe in our Sales and Marketing organization. 6 International Approximately 34.9% of our total revenue was from outside the United States in 2024. We sell through distributors, resellers, and home medical equipment providers in certain markets within Europe and several other markets.
As of December 31, 2025, we employed 314 people in the United States in our Sales and Marketing organization. International Approximately 39.8% of our total revenue was from outside the United States in 2025. We sell through distributors, resellers, and home medical equipment providers in certain markets within Europe and several other markets.
Our direct-to-consumer sales and marketing efforts are focused on generating awareness and demand for our Inogen One, Inogen Rove and Inogen At Home systems among patients, physicians and other clinicians, and third-party payors.
Our direct-to-consumer sales and marketing efforts are focused on generating awareness and demand for our Inogen products among patients, physicians and other clinicians, and third-party payors.
Information about our executive officers The following table provides certain information about our executive officers as of February 21, 2025. Name Age Position Kevin R. M. Smith 54 Chief Executive Officer, President and Director Michael Bourque 62 Executive Vice President, Chief Financial Officer and Corporate Treasurer Kevin P.
Information about our executive officers The following table provides certain information about our executive officers as of February 20, 2026. Name Age Position Kevin R.M. Smith 55 Chief Executive Officer, President and Director Michael Bourque 63 Executive Vice President, Chief Financial Officer and Corporate Treasurer Kevin P.
For example, U.S. patents 8,702,841; 9,220,864; and 9,283,346 are directed towards design features of the Inogen One G3, Inogen One G4, and Inogen at Home products. This category of patents expires in 2031 or later (without taking into account any patent term adjustments). These features and designs are developed to facilitate the design, manufacturing, and usefulness of our products.
For example, U.S. patents 8,702,841; 9,220,864; and 9,283,346 are directed towards design features of the Inogen One G3, Inogen One G4, and Inogen at Home products. This category of patents generally expires in 2031 or later (without taking into account any patent term adjustments or terminal disclaimers).
Licensure, registrations, and accreditation In April 2009, we became an accredited Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Medicare supplier by the Accreditation Commission for Health Care for our Goleta, California facility for Home/Durable Medical Equipment Services for oxygen equipment and supplies. Our Medicare accreditation must be renewed every three years by passing an on-site inspection.
Licensure, registrations, and accreditation In April 2009, we became an accredited Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Medicare supplier by the Accreditation Commission for Health Care for our Goleta, California facility for Home/Durable Medical Equipment Services for oxygen equipment and supplies.
Medicare’s service reimbursement programs accounted for 56.3%, 67.7% and 77.0% of rental revenue in 2024, 2023 and 2022, respectively, and accounted for 9.5%, 13.7% and 11.6% of total revenue for 2024, 2023 and 2022, respectively.
Medicare’s service reimbursement programs accounted for 61.9%, 56.3% and 67.7% of rental revenue in 2025, 2024 and 2023, respectively, and accounted for 9.5%, 9.5% and 13.7% of total revenue for 2025, 2024 and 2023, respectively.
Over time it can lead to a lack of oxygen in organs and tissues, known as hypoxia, and acute respiratory failure. As COPD progresses into later stages, patients may need long-term oxygen therapy as part of their treatment.
Hypoxemic patients are unable to convert oxygen found in the air into the bloodstream in an efficient manner. Over time it can lead to a lack of oxygen in organs and tissues, known as hypoxia, and acute respiratory failure. As COPD progresses into later stages, patients may need long-term oxygen therapy as part of their treatment.
The Inogen Rove 4 is among the lightest products on the market and has among the highest oxygen production capabilities. The performance parameters around our systems allow us to serve ambulatory long-term oxygen patients based on their clinical needs. Our products enable us to address a patient’s particular clinical needs, as well as lifestyle and performance preferences.
The Inogen Rove 4 is our newest POC and is among the lightest products on the market and has among the highest oxygen production capabilities. The performance parameters around our systems allow us to serve ambulatory long-term oxygen patients based on their clinical needs.
Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions: warning letters, fines, injunctions, civil or criminal penalties, recall or seizure of our products, import detention, operating restrictions, partial suspension or total shutdown of production, refusing our request for 510(k) clearance or pre-market approval of new products, rescinding previously granted 510(k) clearances or withdrawing previously granted pre-market approvals.
Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions: warning letters, fines, injunctions, civil or criminal penalties, recall or seizure of our products, import detention, operating restrictions, partial suspension or total shutdown of production, refusing our request for 510(k) clearance or pre-market approval of new products, rescinding previously granted 510(k) clearances, or withdrawing previously granted pre-market approvals. 11 As a medical device manufacturer, our manufacturing facilities are subject to periodic inspections and audits by the FDA, certain other regulatory agencies and authorities, and our notified body.
Health and safety Our approach to health and safety uses our management systems, preventative training, problem solving safety committees, and our quality culture to minimize workplace incidents and maximize the care taken for employees who suffer from a workplace incident, per our health and safety policy.
Health and safety Our approach to health and safety uses our management systems, preventative training, problem solving safety committees, and our quality culture to minimize workplace incidents and maximize the care taken for employees who suffer from a workplace incident, per our health and safety policy. Inogen also has a corporate wellness program to promote improved physical and emotional wellbeing.
We believe that we can develop the market and expand growth opportunities by educating providers and generating clinical evidence. Our clinical approach involves investing in clinical studies and engaging with key opinion leaders, or KOLs, through our Scientific Advisory Board.
We believe that we can develop the market and expand growth opportunities by educating providers and generating clinical evidence. Our clinical approach involves investing in clinical studies and engaging with key opinion leaders, or KOLs, through our Scientific Advisory Board. The KOLs are focused on advocating for the right therapy for patients and changing the behavior of prescribers.
The team is augmented with expertise and resources of our third-party partners specialized in medical device development. Our current research and development efforts are focused primarily on increasing functionality, improving design for ease-of-use, and reducing the total cost of ownership of our products, as well as developing our next-generation oxygen concentrators and further developing the Simeox product line.
Our current research and development efforts are focused primarily on increasing functionality, improving design for ease-of-use, and reducing the total cost of ownership of our products, as well as developing our next-generation oxygen concentrators and further developing the Simeox product line.
The Inogen One G4 ® can operate up to 60 months when used for up to eleven hours per day. Servicing of sieve beds, filters, and accessories can be performed by patients themselves for all of our current portable product offerings. The technology in our Inogen One and Inogen Rove systems are effective for nocturnal use.
Servicing of sieve beds, filters, and accessories can be performed by patients themselves for all of our current portable product offerings. The technology in our Inogen One and Inogen Rove systems are effective for nocturnal use.
We have also launched Inogen Connect, a wireless connectivity platform for the Inogen One G4, Inogen One G5, Inogen Rove 4 and Inogen Rove 6 consisting of a front-end mobile application for use by long-term oxygen therapy users and a back-end database portal for use by homecare providers.
We have also launched Inogen Connect, a wireless connectivity platform for the Inogen One and Rove POCs consisting of a front-end mobile application for use by patients and a back-end database portal for use by homecare providers.
This category of patents expires in 2031 or later and may serve to deter competitors from reverse engineering or copying our design elements. The second category of patents and patent applications within our portfolio pertains to operating features and design techniques.
This category of patents generally expires in 2031 or later (without taking into account any patent term adjustments or terminal disclaimers) and may serve to deter competitors from copying our design elements. The second category of patents and patent applications within our portfolio pertains to operating features and design techniques.
As more home medical equipment, or HME, providers adopt portable oxygen concentrators in their businesses, we expect our historical seasonality in the domestic business-to-business channel could change as well, which was previously influenced mainly by consumer buying patterns.
As more home medical equipment, or HME, providers adopt portable oxygen concentrators in their businesses, we expect our historical seasonality in the domestic business-to-business channel could change as well, which was previously influenced mainly by consumer buying patterns. Direct-to-consumer sales seasonality may also be impacted by the number of sales representatives and the amount of marketing spend in each quarter.
We believe features of the back-end database portal such as remote troubleshooting, equipment health checks, and a location tracker will drive operational efficiencies for home oxygen providers and lower the total cost of servicing oxygen therapy patients. We released our latest portable oxygen concentrator, Rove 4, in the U.S. and European Union in October 2024.
We believe features of the back-end database portal such as remote troubleshooting, equipment health checks, and a location tracker will drive operational efficiencies for home oxygen providers and lower the total cost of servicing oxygen therapy patients.
Employees As of December 31, 2024, we had 766 full and part-time employees worldwide, consisting of 356 employees in sales, marketing, clinical and client services, 187 employees in operations, manufacturing, quality assurance, manufacturing engineering, and repair, 185 employees in general administration and 38 employees in research and development.
Employees As of December 31, 2025, we had 753 full and part-time employees worldwide, consisting of 333 employees in sales, marketing, clinical, and client services; 178 employees in operations, manufacturing, quality assurance, manufacturing engineering, and repair; 200 employees in general administration; and 42 employees in research and development.
These patents and patent applications provide coverage for the aspects of the Simeox device and potential improvements and adaptions that may be implemented into the device or similar devices in the future. Trademarks We own a number of United States registered trademarks that we use in our business.
These patents and patent applications provide coverage for the aspects of the Simeox device and potential improvements and adaptions that may be implemented into the device or similar devices in the future.
We rely significantly on reimbursement from Medicare, Medicaid and private payors, including Medicare Advantage plans and patients for our rental revenue. For the year ended December 31, 2024, approximately 56.3% of our rental revenue was derived from Medicare’s traditional fee-for-service reimbursement programs.
We rely significantly on reimbursement from Medicare, Medicaid, and private payors, including Medicare Advantage plans and patients, for our rental revenue. For the year ended December 31, 2025, approximately 61.9% of our rental revenue was derived from Medicare’s traditional fee-for-service reimbursement programs. For additional discussion of the impact of Medicare on our business, see “Risk Factors” herein.
We have created a market leading portfolio of POCs. POC product features We market our current portable product offerings, the Inogen Rove and Inogen One systems, as ambulatory solutions for long-term oxygen therapy.
We market our current portable product offerings, the Inogen Rove and Inogen One systems, as ambulatory solutions for long-term oxygen therapy.
We provide our patients with a dedicated 24/7 hotline, allowing direct access to our customer service representatives who can handle product-related questions. Additionally, clinical staff is on call 24/7 and available to patients whenever needed by the patient or the customer service representative.
We provide our patients with a dedicated 24/7 hotline, allowing direct access to our customer service representatives who can handle product-related questions. Additionally, clinical staff are available to patients whenever needed by the patient or the customer service representative. Our rental intake staff supports patients who wish to use their insurance benefits to receive our products and services.
The Physician Payments Sunshine Act, enacted as part of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, imposed public reporting requirements on medical device manufacturers for payments or other transfers of value made by them to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
The Physician Payments Sunshine Act, enacted as part of the Patient Protection and Affordable Care Act, and later amended, requires medical device manufacturers to publicly report certain payments or other transfers of value made to physicians, other prescribers, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
Also, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device.
During this review period, the FDA may request additional information or clarification of the information already provided. Also, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device.
The method of assessing conformity under the MDR varies depending on the type and class of the product, but normally involves a combination of self-assessment by the manufacturer and a third-party assessment by a notified body, an independent and neutral institution designated by a Member State country to conduct the conformity assessment.
Conformity assessment under the MDR varies based on device classification and typically involves a combination of manufacturer self-assessment and third-party review by a notified body, an independent and neutral institution designated by a Member State country to conduct the conformity assessment.
The main cause of COPD is smoking, but other factors like air pollution, secondhand smoke and dust, as well as fumes and chemicals can cause COPD. There is currently no cure for COPD, and it is a progressive and debilitating disease that is characterized by a gradual loss of lung function and airflow limitation that is not fully reversible.
The primary risk for developing COPD is smoking, but other factors, including air pollution, secondhand smoke, dust, fumes, and chemical exposures, are also associated with COPD. There is currently no cure for COPD, and it is a progressive and debilitating disease that is characterized by a gradual loss of lung function and airflow limitation that is not fully reversible.
Of the $218.5 million of our 2024 revenue derived from the United States, approximately 38.2% represented sales to traditional home medical equipment providers, distributors (including our private label collaborator) and resellers, 35.7% represented direct-to-consumer sales, and 26.1% represented direct-to-consumer rentals.
Of the $209.8 million of our 2025 revenue derived from the United States, approximately 45.1% represented sales to traditional home medical equipment providers, distributors (including our private label collaborator) and resellers; 29.5% represented direct-to-consumer sales; and 25.4% represented direct-to-consumer rentals.
An entity that offers to or transfers remuneration to any individual eligible for benefits under Medicare or Medicaid that such entity knows or should know is likely to influence such individual to order or receive from a particular provider, practitioner, or supplier any Medicare or Medicaid payable item or service may be liable for CMPs.
An entity may be subject to CMPs if it offers to or transfers remuneration to any individual eligible for benefits under Medicare or Medicaid that the entity knows or should know is likely to influence such individual's selection of a particular provider, practitioner, or supplier of Medicare or Medicaid payable items or services.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeRisk factors include, but are not limited to, statements concerning the following: Risks related to our business and strategy: • the intense international, national, regional and local competition we face in our industry; • our dependence on a limited number of customers for a significant portion of our sales revenue; • our reliance on a single source or a limited group of manufacturers or suppliers; • the lack of long-term supply contracts with many of our third-party suppliers; • the need to continue to enhance our existing products and develop and market new products; • potential acquisitions of, or investments in, other companies; • the complex and lengthy reimbursement process we depend upon for a significant portion of our revenue; • increases in our operating costs; • economic impacts that affect customer and consumer spending as well as demand for our products; • public health threats and epidemics; • the competitive bidding process or other reimbursement policy changes under Medicare or other third-party payors, including recently enacted and potential future changes in the reimbursement rates or payment methodologies under Medicare, Medicaid and other government programs; • consolidation in the healthcare industry; • healthcare reform measures; • the possibility our manufacturing facilities could become unavailable or inoperable and other potential manufacturing problems or delays; • our reliance upon a third-party contract manufacturer for certain manufacturing and repair operations; • potential failure to maintain or obtain new private payor contracts and future reductions in reimbursement rates from private payors; • the possibility of non-payment of our HME providers, distributors, private label partners and resellers; • our international sales and manufacturing activities; • warranty or product liability claims or other litigation; • our dependence on the services of our senior executives and other key technical personnel; • variance in our financial condition and results of operations; • the market opportunities for our products; and • our ability to maintain effective internal controls. 21 Risks related to the regulatory environment: • extensive federal, state, and international regulations related to our business by numerous government agencies, including the FDA and the MDR; • the potential need to seek additional clearances or approvals for our products; and • potential FDA, state, or international regulatory enforcement action and other penalties.
Biggest changeRisk factors include, but are not limited to, statements concerning the following: Risks related to our business and strategy: • the intense international, national, regional and local competition we face in our industry; • our dependence on a limited number of customers for a significant portion of our sales revenue both domestically and internationally; • our reliance on a single source or a limited group of manufacturers or suppliers; • the need to continue to enhance our existing products and develop and market new products; • the complex and lengthy reimbursement process we depend upon for a significant portion of our revenue; • increases in our operating costs; • economic impacts that affect customer and consumer spending as well as demand for our products; • public health threats and epidemics; • changes in Medicare, Medicaid, and other third party payor reimbursement policies, including the competitive bidding and coverage determinations including recently enacted and potential future changes in the reimbursement rates or payment methodologies under Medicare, Medicaid and other government programs; • consolidation in the healthcare industry; • healthcare reform measures; • ability to maintain or obtain new private payor contracts and future reductions in reimbursement rates from private payors; • the possibility our manufacturing facilities could become unavailable or inoperable and other potential manufacturing problems or delays; • our reliance upon a third-party contract manufacturer for certain manufacturing and repair operations; • the possibility of non-payment of our HME providers, distributors, private label partners and resellers; • our ability to comply with anti-bribery, anti-corruption, and similar laws associated with our activities outside of the U.S., and anti-money laundering laws; • ability to comply with U.S. and applicable foreign export controls and economic sanctions, maintain an effective sales force or successfully develop our international distribution network; • warranty or product liability claims or other litigation; • our dependence on the services of our senior executives and other key technical personnel; • our ability to protect against service interruptions, data corruption, cybersecurity risks, data security incidents and/or network security breaches; • data privacy and data protection regulations; • variance in our financial condition and results of operations; • the market opportunities for our products; and • our ability to maintain effective internal controls. 20 Risks related to the regulatory environment: • extensive federal, state, and international regulations related to our business by numerous government agencies, including the FDA and the EU competent authorities; • the potential need to seek additional clearances or approvals for our products; and • potential FDA, state, or international regulatory enforcement action and other penalties.
If we are unable to continue to enhance our existing products, develop or acquire and market our products that respond to customer needs and preferences and achieve market acceptance, we may experience a decrease in demand for our products and our business could suffer.
If we are unable to continue to enhance our existing products, develop or acquire and market products that respond to customer needs and preferences and achieve market acceptance, we may experience a decrease in demand for our products and our business could suffer.
Additionally, future legislation, regulation, or reimbursement policies of third-party payors may otherwise adversely our ability to operate our rental business in a profitable manner and affect the demand for and price levels of our products.
Additionally, future legislation, regulation, or reimbursement policies of third-party payors may otherwise adversely affect our ability to operate our rental business in a profitable manner and affect the demand for and price levels of our products.
There are a number of risks associated with our dependence on a contract manufacturer, including: • reduced control over delivery schedules and planning; • reliance on the quality assurance procedures of a third party; • risks associated with our contract manufacturer failing to manufacture our products according to our specifications, quality regulations, including the FDA’s quality system regulations, or otherwise manufacturing products that we or regulatory authorities deem to be unsuitable for commercial use; • risks associated with our contract manufacturer’s ability to successfully undergo FDA and other regulatory authority quality inspections; • potential uncertainty regarding manufacturing yields and costs; • availability of manufacturing capability and capacity, particularly during periods of high demand; • risks and uncertainties associated with the location or country where our products are manufactured, including potential manufacturing disruptions caused by social, geopolitical or environmental factors; • changes in U.S. law or policy governing foreign trade, manufacturing, development and investment in the countries where we manufacture our products, including the World Trade Organization Information Technology Agreement or other free trade agreements; • delays in delivery by suppliers due to customs clearing delays, shipping delays, scarcity of raw materials and changes in demand from us or their other customers; • limited warranties provided to us; and • potential misappropriation of our intellectual property.
There are a number of risks associated with our dependence on a contract manufacturer, including: • reduced control over delivery schedules and planning; • reliance on the quality assurance procedures of a third party; 32 • risks associated with our contract manufacturer failing to manufacture our products according to our specifications, quality regulations, including the FDA’s quality system regulations, or otherwise manufacturing products that we or regulatory authorities deem to be unsuitable for commercial use; • risks associated with our contract manufacturer’s ability to successfully undergo FDA and other regulatory authority quality inspections; • potential uncertainty regarding manufacturing yields and costs; • availability of manufacturing capability and capacity, particularly during periods of high demand; • risks and uncertainties associated with the location or country where our products are manufactured, including potential manufacturing disruptions caused by social, geopolitical or environmental factors; • changes in U.S. law or policy governing foreign trade, manufacturing, development and investment in the countries where we manufacture our products, including the World Trade Organization Information Technology Agreement or other free trade agreements; • delays in delivery by suppliers due to customs clearing delays, shipping delays, scarcity of raw materials and changes in demand from us or their other customers; • limited warranties provided to us; and • potential misappropriation of our intellectual property.
Bribery Act, data privacy and data protection regulations, such as the European Union General Data Protection Regulation, or GDPR, labor laws, and anti-competition regulations; • export or import delays and restrictions; • obtaining and maintaining regulatory clearances, approvals and certifications; • laws and business practices favoring local companies; • difficulties in enforcing agreements and collecting receivables through certain foreign legal systems; • unstable economic, political, and regulatory conditions, including as a result of recessionary effects or inflationary pressures; • supply chain complexities; • fluctuations in currency exchange rates; • fluctuations in demand due to country-specific tenders and tender uncertainty and capital expenditure constraints; • potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements, and other trade barriers; • any other government actions, by the United States, China or other countries, that impose tariffs, barriers or restrictions that would impact our ability to sell or ship products to customers; and • difficulties protecting or procuring intellectual property rights.
Bribery Act, data privacy and data protection regulations, such as the European Union General Data Protection Regulation, or GDPR, labor laws, and anti-competition regulations; • export or import delays and restrictions; 33 • obtaining and maintaining regulatory clearances, approvals, and certifications; • laws and business practices favoring local companies; • difficulties in enforcing agreements and collecting receivables through certain foreign legal systems; • unstable economic, political, and regulatory conditions, including as a result of recessionary effects or inflationary pressures; • supply chain complexities; • fluctuations in currency exchange rates; • fluctuations in demand due to country-specific tenders and tender uncertainty and capital expenditure constraints; • potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements, and other trade barriers; • any other government actions, by the United States, China, or other countries, that impose tariffs, barriers or restrictions that would impact our ability to sell or ship products to customers; and • difficulties protecting or procuring intellectual property rights.
Our certificate of incorporation and bylaws include provisions that: • authorize our board of directors to issue, without further action by the stockholders, up to 10,000,000 shares of undesignated preferred stock; • require that any action to be taken by our stockholders be affected at a duly called annual or special meeting and not by written consent; • specify that special meetings of our stockholders can be called only by our board of directors, the Chairman of the board of directors, or the Chief Executive Officer; • establish an advance notice procedure for stockholder approvals to be brought before an annual meeting of our stockholders, including proposed nominations of persons for election to our board of directors; • establish that our board of directors is divided into three classes, Class I, Class II and Class III, with each class serving staggered three-year terms; • provide that our directors may be removed only for cause; • provide that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum; 55 • specify that no stockholder is permitted to cumulate votes at any election of directors; and • require a super-majority of votes to amend certain of the above-mentioned provisions.
Our certificate of incorporation and bylaws include provisions that: • authorize our board of directors to issue, without further action by the stockholders, up to 10,000,000 shares of undesignated preferred stock; • require that any action to be taken by our stockholders be affected at a duly called annual or special meeting and not by written consent; • specify that special meetings of our stockholders can be called only by our board of directors, the Chairman of the board of directors, or the Chief Executive Officer; • establish an advance notice procedure for stockholder approvals to be brought before an annual meeting of our stockholders, including proposed nominations of persons for election to our board of directors; • establish that our board of directors is divided into three classes, Class I, Class II and Class III, with each class serving staggered three-year terms; • provide that our directors may be removed only for cause; • provide that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum; • specify that no stockholder is permitted to cumulate votes at any election of directors; and • require a super-majority of votes to amend certain of the above-mentioned provisions.
If we fail to implement timely and appropriate corrective actions that are acceptable to the FDA or if our other manufacturing facilities or those of any of our contract manufacturers are found to be in violation of applicable laws and regulations, or we or our contract manufacturers fail to take prompt and satisfactory corrective action in response to an adverse inspection, the FDA could take enforcement action, including, among others, the following sanctions: • adverse publicity, untitled letters, warning letters, import detentions, fines, injunctions, consent decrees and civil penalties; • customer notifications or repair, replacement, refunds, recall, detention or seizure of our products; • operating restrictions or partial suspension or total shutdown of production; • refusing or delaying our requests for pre-market approval of new products or modified products; • withdrawing 510(k) clearances or other pre-market approvals that have already been granted; • refusal to grant export approval for our products; or • criminal prosecution.
If we fail to implement timely and appropriate corrective actions that are acceptable to the FDA or if our other manufacturing facilities or those of any of our contract manufacturers are found to be in violation of applicable laws and regulations, or we or our contract manufacturers fail to take prompt and satisfactory corrective action in response to an adverse inspection, the FDA could take enforcement action, including, among others, the following sanctions: • adverse publicity, untitled letters, warning letters, import detentions, fines, injunctions, consent decrees and civil penalties; • customer notifications or repair, replacement, refunds, recall, detention or seizure of our products; • operating restrictions or partial suspension or total shutdown of production; • refusing or delaying our requests for pre-market approval of new products or modified products; • withdrawing 510(k) clearances or other pre-market approvals that have already been granted; 42 • refusal to grant export approval for our products; or • criminal prosecution.
Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA or state agencies, which may include any of the following sanctions: • adverse publicity, warning letters, fines, injunctions, consent decrees and civil penalties; • recalls, import detentions, termination of distribution, or seizure of our products; • operating restrictions or partial suspension or total shutdown of production; • delays in the introduction of products into the market; • refusal to grant our requests for future 510(k) clearances or approvals of new products, new intended uses, or modifications to existing products; • withdrawals or suspensions of current 510(k) clearances or approvals, resulting in prohibitions on sales of our products; and • criminal prosecution.
Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA or state agencies, which may include any of the following sanctions: • adverse publicity, warning letters, fines, injunctions, consent decrees and civil penalties; • recalls, import detentions, termination of distribution, or seizure of our products; • operating restrictions or partial suspension or total shutdown of production; • delays in the introduction of products into the market; • refusal to grant our requests for future 510(k) clearances or approvals of new products, new intended uses, or modifications to existing products; 41 • withdrawals or suspensions of current 510(k) clearances or approvals, resulting in prohibitions on sales of our products; and • criminal prosecution.
Our dependence on single-source or limited-source suppliers of components may expose us to several risks, including, among other things: • our suppliers or their component sub-suppliers may be unable to meet demands due to global supply chain disruptions; • we may experience delays in delivery by our suppliers due to customs clearing delays, shipping delays, scarcity of raw materials and components or changes in demand from us or their other customers; • our suppliers may be unable to meet demands due to the effect of exposure to infectious diseases, epidemics or other public health emergencies, or due to acts of terrorism, hostilities, military conflict or war, including the conflict between Israel and Hamas and the war in Ukraine; • we may not be able to find new or alternative components, even at elevated prices, or reconfigure our system and manufacturing processes in a timely manner if the necessary components become unavailable, which could lead to a production slowdown or temporary stoppage; • our suppliers may encounter financial hardships as a result of unfavorable economic and market conditions unrelated to our demand for components, which could inhibit their ability to fulfill our orders and meet our requirements; • suppliers may fail to comply with regulatory requirements, be subject to lengthy compliance, validation or qualification periods, or make errors in manufacturing components that could negatively affect the performance or safety of our products, cause delays in supplying of our products to our customers, or result in regulatory enforcement against us or our suppliers; • newly identified suppliers may not qualify under the stringent quality regulatory standards to which our business is subject, which could inhibit their ability to fulfill our orders and meet our requirements; • we or our suppliers may not be able to respond to unanticipated changes in customer orders, and if orders do not match forecasts, we or our suppliers may have excess or inadequate inventory of materials and components; • we may be subject to price fluctuations due to a lack of long-term supply arrangements for key components or changes in import tariffs, trade restrictions or barriers or other government actions that impact our ability to obtain such components; • we or our suppliers may lose access to critical services, tools, moldings, and components, resulting in an interruption in the manufacture, assembly and shipment of our systems; • our suppliers may be subject to allegations by other parties of misappropriation of proprietary information in connection with their supply of products to us, which could inhibit their ability to fulfill our orders and meet our requirements; • fluctuations in demand for products that our suppliers manufacture for others may affect their ability or willingness to deliver components to us in a timely manner; and • our suppliers may wish to discontinue supplying components or services to us.
Our dependence on single-source or limited-source suppliers of components may expose us to several risks, including, among other things: • our suppliers or their component sub-suppliers may be unable to meet demands due to global supply chain disruptions; 22 • we may experience delays in delivery by our suppliers due to customs clearing delays, shipping delays, scarcity of raw materials and components or changes in demand from us or their other customers; • our suppliers may be unable to meet demands due to the effect of exposure to infectious diseases, epidemics or other public health emergencies, or due to acts of terrorism, hostilities, military conflict or war, including the conflict between Israel and Hamas and the war in Ukraine; • we may not be able to find new or alternative components, even at elevated prices, or reconfigure our system and manufacturing processes in a timely manner if the necessary components become unavailable, which could lead to a production slowdown or temporary stoppage; • our suppliers may encounter financial hardships as a result of unfavorable economic and market conditions unrelated to our demand for components, which could inhibit their ability to fulfill our orders and meet our requirements; • suppliers may fail to comply with regulatory requirements, be subject to lengthy compliance, validation or qualification periods, or make errors in manufacturing components that could negatively affect the performance or safety of our products, cause delays in supplying of our products to our customers, or result in regulatory enforcement against us or our suppliers; • newly identified suppliers may not qualify under the stringent quality regulatory standards to which our business is subject, which could inhibit their ability to fulfill our orders and meet our requirements; • we or our suppliers may not be able to respond to unanticipated changes in customer orders, and if orders do not match forecasts, we or our suppliers may have excess or inadequate inventory of materials and components; • we may be subject to price fluctuations due to a lack of long-term supply arrangements for key components or changes in import tariffs, trade restrictions or barriers, or other government actions that impact our ability or the costs to obtain such components; • we or our suppliers may lose access to critical services, tools, moldings, and components, resulting in an interruption in the manufacture, assembly, and shipment of components or products; • our suppliers may be subject to allegations by other parties of misappropriation of proprietary information in connection with their supply of products to us, which could inhibit their ability to fulfill our orders and meet our requirements; • fluctuations in demand for products that our suppliers manufacture for others may affect their ability or willingness to deliver components to us in a timely manner; and • our suppliers may wish to discontinue supplying components or services to us.
Acquisitions, collaborations and other strategic investments involve significant risks and uncertainties, including: • the potential failure to achieve the expected benefits of the combination, acquisition or collaboration; • the potential failure to successfully develop or commercialize the acquired products or technology; • unanticipated costs and liabilities; • difficulties in integrating new products, businesses, operations, and technology infrastructure in an efficient and effective manner; • difficulties in maintaining customer relations; • the potential loss of key employees of any acquired businesses; 25 • the diversion of the attention of our senior management from the operation of our daily business; • the potential adverse effect on our cash position to the extent that we use cash for the purchase price; • the potential incurrence of interest expense and debt service requirements if we incur debt to pay for an acquisition; • the potential issuance of securities that would dilute our stockholders’ percentage ownership; • the potential to incur large and immediate write-offs and restructuring and other related expenses; • the potential of amortization expenses related to intangible assets; • the potential failure to achieve anticipated reimbursement classifications for any acquired products; • the potential to become involved in intellectual property litigation related to such acquisitions, collaborations or strategic investments; and • the inability to maintain uniform standards, controls, policies, and procedures.
Acquisitions, collaborations and other strategic investments involve significant risks and uncertainties, including: • the potential failure to achieve the expected benefits of the combination, acquisition, or collaboration; 24 • the potential failure to successfully develop or commercialize the acquired products or technology; • unanticipated costs and liabilities; • difficulties in integrating new products, businesses, operations, and technology infrastructure in an efficient and effective manner; • difficulties in maintaining customer relations; • the potential loss of key employees of any acquired businesses; • the diversion of the attention of our senior management from the operation of our daily business; • the potential adverse effect on our cash position to the extent that we use cash for the purchase price; • the potential incurrence of interest expense and debt service requirements if we incur debt to pay for an acquisition; • the potential issuance of securities that would dilute our stockholders’ percentage ownership; • the potential to incur large and immediate write-offs and restructuring and other related expenses; • the potential of amortization expenses related to intangible assets; • the potential failure to achieve anticipated reimbursement classifications for any acquired products; • the potential to become involved in intellectual property litigation related to such acquisitions, collaborations, or strategic investments; and • the inability to maintain uniform standards, controls, policies, and procedures.
We determined that the goodwill carrying amount exceeded its fair value and, as such, an impairment charge of $32.9 million was incurred in the quarter ended September 30, 2023. In several recent situations where the market price of a stock has been volatile, holders of that stock have instituted securities class action litigation against the company that issued the stock.
We determined that the goodwill carrying amount exceeded its fair value and, as such, an impairment charge of $32.9 million was incurred in the quarter ended September 30, 2023. 51 In several recent situations where the market price of a stock has been volatile, holders of that stock have instituted securities class action litigation against the company that issued the stock.
In addition, we may become subject to covenants under future debt arrangements that place restrictions on our ability to pay dividends. As a result, capital appreciation, if any, of our common stock is expected to be your sole source of gain for the foreseeable future. ITEM 1B. UNRESOLVE D STAFF COMMENTS None.
In addition, we may become subject to covenants under future debt arrangements that place restrictions on our ability to pay dividends. As a result, capital appreciation, if any, of our common stock is expected to be your sole source of gain for the foreseeable future. 53 ITEM 1B. UNRESOLVE D STAFF COMMENTS None.
We cannot ensure that we will be able to continue to effectively manage the process which would adversely affect our business, financial condition and results of operations. In addition, we are subject to complex billing and record-keeping requirements in order to substantiate our claims for payment under federal, state and commercial healthcare reimbursement programs.
We cannot ensure that we will be able to continue to effectively manage the process which would adversely affect our business, financial condition, and results of operations. In addition, we are subject to complex billing and record-keeping requirements to substantiate our claims for payment under federal, state, and commercial healthcare reimbursement programs.
As a result, this could adversely affect our business, financial conditions and results of operations. 49 Risks related to our intellectual property If we are unable to secure and maintain patent or other intellectual property protection for the intellectual property used in our products, we will lose a significant competitive advantage, which may adversely affect our future profitability.
As a result, this could adversely affect our business, financial conditions and results of operations. Risks related to our intellectual property If we are unable to secure and maintain patent or other intellectual property protection for the intellectual property used in our products, we will lose a significant competitive advantage, which may adversely affect our future profitability.
This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. 52 The Sarbanes-Oxley Act requires, among other things, that we assess and document the effectiveness of our internal control over financial reporting annually and the effectiveness of our disclosure controls and procedures quarterly.
This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. The Sarbanes-Oxley Act requires, among other things, that we assess and document the effectiveness of our internal control over financial reporting annually and the effectiveness of our disclosure controls and procedures quarterly.
We may not be able to compete as effectively with our competitors and ultimately satisfy the needs and preferences of our customers unless we can continue to enhance existing products, acquire companies with new or different products, sell our existing products, and develop new and innovative products ourselves. Product development requires significant financial, technological and other resources.
We may not be able to compete as effectively with our competitors and ultimately satisfy the needs and preferences of our customers unless we continue to enhance existing products, acquire companies with new or different products, sell our existing products, and develop innovative products ourselves. Product development requires significant financial, technological and other resources.
These mandatory disclosures regarding a security breach could result in negative publicity to us, which may cause our customers to lose confidence in the effectiveness of our data security measures which could adversely affect our business, financial condition and results of operations. Increasing data privacy and data protection regulations could impact our business and expose us to increased liability.
These mandatory disclosures regarding a security breach could result in negative publicity for us, which may cause our customers to lose confidence in the effectiveness of our data security measures which could adversely affect our business, financial condition, and results of operations. Increasing data privacy and data protection regulations could impact our business and expose us to increased liability.
If one or more of these risks occurs, it could require us to dedicate significant resources to remedy, and if we are unsuccessful in finding a solution, our financial condition and results of operations will suffer. 35 A portion of our international product sales are currently denominated in U.S. dollars.
If one or more of these risks occurs, it could require us to dedicate significant resources to remedy, and if we are unsuccessful in finding a solution, our financial condition and results of operations will suffer. A portion of our international product sales are currently denominated in U.S. dollars.
We currently derive the majority of our revenue from rentals or sales generated from our own direct sales force. Failure to maintain or expand our direct sales force could adversely affect our financial condition and results of operations. Additionally, we use international distributors to augment our sales efforts, certain of which are exclusive distributors in certain foreign countries.
We currently derive the majority of our revenue from rentals or sales generated from our own sales force. Failure to maintain or expand our sales force could adversely affect our financial condition and results of operations. Additionally, we use international distributors to augment our sales efforts, certain of which are exclusive distributors in certain foreign countries.
The foregoing shall not apply to any claims under the Exchange Act. 54 Any person or entity purchasing or otherwise acquiring or holding or owning (or continuing to hold or own) any interest in any of our securities shall be deemed to have notice of and consented to the foregoing provisions of the bylaws and certificate of incorporation.
The foregoing shall not apply to any claims under the Exchange Act. Any person or entity purchasing or otherwise acquiring or holding or owning (or continuing to hold or own) any interest in any of our securities shall be deemed to have notice of and consented to the foregoing provisions of the bylaws and certificate of incorporation.
In addition, California voters recently passed the California Privacy Rights Act, or CPRA, which modified the CCPA significantly as of January 1, 2023, potentially resulting in further uncertainty and requiring us to incur additional costs and expenses in an effort to comply.
In addition, California voters passed the California Privacy Rights Act, or CPRA, which modified the CCPA significantly as of January 1, 2023, potentially resulting in further uncertainty and requiring us to incur additional costs and expenses in an effort to comply.
There is no assurance that we will not experience service interruptions, security breaches, cybersecurity risks and data security incidents, or other information technology failures, whether suffered by us or third parties on which we rely, in the future. 38 We receive, collect, process, use and store a large amount of information from our customers, our patients and our own employees, including personal information, intellectual property, protected health and other sensitive and confidential information.
There is no assurance that we will not experience service interruptions, security breaches, cybersecurity risks and data security incidents, or other information technology failures, whether suffered by us or third parties on which we rely, in the future. 36 We receive, collect, process, use and store a large amount of information from our customers, our patients and our own employees, including personal information, intellectual property, protected health and other sensitive and confidential information.
In the 510(k) clearance process, the FDA must determine that a proposed device is “substantially equivalent” to a legally marketed predicate device in order to clear the proposed device for marketing. Our commercial products have received 510(k) clearance by the FDA.
In the 510(k) clearance process, the FDA must determine that a proposed device is “substantially equivalent” to a legally marketed predicate device to clear the proposed device for marketing. Our commercial products have received 510(k) clearance by the FDA.
We may experience numerous unforeseen events in relation to a clinical trial process that could delay or prevent us from receiving regulatory clearance or approval for new products or modifications of existing products, including new indications for existing products, including: • delays or failure in obtaining approval of our clinical trial protocols from the FDA, other regulatory authorities, or IRBs; • we, the applicable IRB(s), or the FDA or other applicable regulatory authorities may require that we or our investigators suspend or terminate our data collection for various reasons, including, among others (i) failure to conduct the clinical trial in accordance with regulatory requirements, including the FDA’s current Good Clinical Practice, regulations, or our clinical protocols, or (ii) lack of adequate patient informed consent; and • delays if the FDA concludes that our financial relationships with our data collection partners result in a perceived or actual conflict of interest that may have affected the interpretation or integrity of the data collected.
We may experience numerous unforeseen events in relation to a clinical trial process that could delay or prevent us from receiving regulatory clearance or approval or reimbursement from payors for new products or modifications of existing products, including new indications for existing products, including: • delays or failure in obtaining approval of our clinical trial protocols from the FDA, other regulatory authorities, or IRBs; 43 • we, the applicable IRB(s), or the FDA or other applicable regulatory authorities may require that we or our investigators suspend or terminate our data collection for various reasons, including, among others (i) failure to conduct the clinical trial in accordance with regulatory requirements, including the FDA’s current Good Clinical Practice, regulations, or our clinical protocols, or (ii) lack of adequate patient informed consent; and • delays if the FDA concludes that our financial relationships with our data collection partners result in a perceived or actual conflict of interest that may have affected the interpretation or integrity of the data collected.
Because of the breadth of these laws and the narrowness of the safe harbors and exceptions, it is possible that some of our business activities could be subject to challenge under one or more of such laws.
Because of the breadth of these laws and the narrowness of the available exceptions and safe harbors, it is possible that some of our business activities could be subject to challenge under one or more of such laws.
This IFR included that for the duration of the COVID-19 PHE, CMS waived the face-to-face requirements and stated it would not enforce clinical indications for home oxygen, among other respiratory products. 28 • The first Trump administration also issued a number of regulatory waivers to increase the flexibility in durable medical equipment, prosthetics, orthotics and supplies, or DMEPOS, suppliers’ ability to service patients quickly and without the normal requirements.
This IFR included that for the duration of the COVID-19 PHE, CMS waived the face-to-face requirements and stated it would not enforce clinical indications for home oxygen, among other respiratory products. 27 • The first Trump administration also issued a number of regulatory waivers to increase the flexibility in durable medical equipment, prosthetics, orthotics and supplies, or DMEPOS, suppliers’ ability to service patients quickly and without the normal requirements.
In addition, while we and our contract manufacturer were able to keep our manufacturing facilities open during the COVID-19 pandemic, there can be no assurance that we would be able to keep such facilities open indefinitely during a future public health emergency. 27 Changes to reimbursement rates, payment methodologies, or coverage policies for our products by government or commercial payors may adversely affect our business and operating results.
In addition, while we and our contract manufacturer were able to keep our manufacturing facilities open during the COVID-19 pandemic, there can be no assurance that we would be able to keep such facilities open indefinitely during a future public health emergency. 26 Changes to reimbursement rates, payment methodologies, or coverage policies for our products by government or commercial payors may adversely affect our business and operating results.
For the years ended December 31, 2024, 2023 and 2022, approximately 17.0%, 20.3% and 15.0%, respectively, of our total revenue was derived from Medicare, private payors, Medicaid, and individual patients who directly receive reimbursement from third-party payors and this percentage could increase as a percent of total revenue if we increase net patient additions faster than our sales revenue growth.
For the years ended December 31, 2025, 2024, and 2023, approximately 15.3%, 17.0% and 20.3%, respectively, of our total revenue was derived from Medicare, private payors, Medicaid, and individual patients who directly receive reimbursement from third-party payors and this percentage could increase as a percent of total revenue if we increase net patient additions faster than our sales revenue growth.
Any adverse determination related to litigation could require us to change our technology or our business practices, pay monetary damages or enter into royalty or licensing arrangements, which could adversely affect our business, financial condition and results of operations. 37 We depend on the services of our senior executives and other key technical personnel, the loss of whom could negatively affect our business.
Any adverse determination related to litigation could require us to change our technology or our business practices, pay monetary damages, or enter into royalty or licensing arrangements, which could adversely affect our business, financial condition and results of operations. 35 We depend on the services of our senior executives and other key technical personnel, the loss of whom could negatively affect our business.
In the past, some of our competitors, which may include distributors, have been lowering the purchase prices of their products in an effort to attract customers.
In the past, some of our competitors, which may include distributors, have been lowering the prices of their products in an effort to attract customers.
In addition, currency hedging may result in a reduction or increase in revenue should the currency strengthen or decline during the contract period. A discussion of the hedging program is contained in Item 7A. Quantitative and Qualitative Disclosures about Market Risk in this Annual Report on Form 10-K for the year ended December 31, 2024.
In addition, currency hedging may result in a reduction or increase in revenue should the currency strengthen or decline during the contract period. A discussion of the hedging program is contained in Item 7A. Quantitative and Qualitative Disclosures about Market Risk in this Annual Report on Form 10-K for the year ended December 31, 2025.
Respiratory therapy providers compete primarily on the basis of product features and service, rather than price, since reimbursement levels are established by Medicare and Medicaid, or by the individual determinations of private payors. 22 Some of our competitors are large, well-capitalized companies with greater resources than we have.
Respiratory therapy providers compete primarily on the basis of product features and service, rather than price, since reimbursement levels are established by Medicare and Medicaid, or by the individual determinations of private payors. 21 Some of our competitors are large, well-capitalized companies with greater resources than we have.
Average Medicare reimbursement rates in rural areas E1390 E1392 As of January 1, 2025 $ 173.32 $ 51.63 As of January 1, 2024 $ 168.96 $ 51.18 As of January 1, 2023 $ 164.48 $ 50.44 As of January 1, 2022 $ 151.15 $ 48.39 As of April 1, 2021 $ 143.48 $ 47.13 As of January 1, 2021 $ 136.84 $ 44.99 As of January 1, 2020 $ 136.71 $ 44.93 As of January 1, 2019 $ 134.71 $ 44.32 As of January 1, 2018 $ 76.31 $ 41.91 Non-former CBAs in non-rural areas: Rates in non-former CBAs that are not defined as rural are set based on the rates in former CBAs.
Average Medicare reimbursement rates in rural areas E1390 E1392 As of January 1, 2026 $ 177.16 $ 51.63 As of January 1, 2025 $ 173.32 $ 51.63 As of January 1, 2024 $ 168.96 $ 51.18 As of January 1, 2023 $ 164.48 $ 50.44 As of January 1, 2022 $ 151.15 $ 48.39 As of April 1, 2021 $ 143.48 $ 47.13 As of January 1, 2021 $ 136.84 $ 44.99 As of January 1, 2020 $ 136.71 $ 44.93 As of January 1, 2019 $ 134.71 $ 44.32 As of January 1, 2018 $ 76.31 $ 41.91 Non-former CBAs in non-rural areas : Rates in non-former CBAs that are not defined as rural are set based on the rates in former CBAs.
With this consolidation, competition to provide goods and services to industry participants may become more intense. These industry participants may try to use their market power to negotiate price concession for our products. These factors could force us to reduce our prices or could result in a loss of customers.
With this consolidation, competition to provide goods and services to industry participants may become more intense. These industry participants may try to use their market power to negotiate price concessions for our products. These factors could force us to reduce our prices or could result in a loss of customers.
Any recall would divert management attention and financial resources, could cause the price of our stock to decline and expose us to product liability or other claims and harm our reputation with customers. A recall involving our Inogen concentrators could be particularly harmful to our business, financial condition and results of operations.
Any recall would divert management attention and financial resources, could cause the price of our stock to decline and expose us to product liability or other claims and harm our reputation with customers. A recall involving our Inogen POCs could be particularly harmful to our business, financial condition, and results of operations.
Average Medicare reimbursement rates in former CBAs E1390 E1392 As of January 1, 2025 $ 96.11 $ 47.11 As of January 1, 2024 $ 93.41 $ 45.78 As of January 1, 2023 $ 90.77 $ 44.49 As of January 1, 2022 $ 85.31 $ 41.81 As of April 1, 2021 $ 81.25 $ 39.82 As of January 1, 2021 $ 73.88 $ 36.20 As of January 1, 2020 $ 73.98 $ 36.25 As of January 1, 2019 $ 72.92 $ 35.72 As of January 1, 2018 $ 77.03 $ 36.06 CMS also issued a final rule in December 2021 (CMS-1738-F) to establish payment methodologies to be effective after the COVID-19 PHE for DMEPOS products and services covered under Medicare. 30 CMS established three different fee schedule adjustment methodologies for non-CBAs after the termination of the COVID-19 PHE: (1) for non-contiguous non-CBAs; (2) for contiguous non-CBAs defined as rural areas; and (3) for non-rural non-CBAs within the contiguous United States.
Average Medicare reimbursement rates in former CBAs E1390 E1392 As of January 1, 2026 $ 98.81 $ 48.42 As of January 1, 2025 $ 96.11 $ 47.11 As of January 1, 2024 $ 93.41 $ 45.78 As of January 1, 2023 $ 90.77 $ 44.49 As of January 1, 2022 $ 85.31 $ 41.81 As of April 1, 2021 $ 81.25 $ 39.82 As of January 1, 2021 $ 73.88 $ 36.20 As of January 1, 2020 $ 73.98 $ 36.25 As of January 1, 2019 $ 72.92 $ 35.72 As of January 1, 2018 $ 77.03 $ 36.06 CMS also issued a final rule in December 2021 (CMS-1738-F) to establish payment methodologies to be effective after the COVID-19 PHE for DMEPOS products and services covered under Medicare. 29 CMS established three different fee schedule adjustment methodologies for non-CBAs after the termination of the COVID-19 PHE: (1) for non-contiguous non-CBAs; (2) for contiguous non-CBAs defined as rural areas; and (3) for non-rural non-CBAs within the contiguous United States.
These legislative provisions have had and may continue to have a material and/or adverse effect on our business, financial condition and results of operations. 29 The OIG has recommended that states review Medicaid reimbursement for durable medical equipment, or DME, and supplies.
These legislative provisions have had and may continue to have a material and/or adverse effect on our business, financial condition and results of operations. 28 The OIG has recommended that states review Medicaid reimbursement for durable medical equipment, or DME, and supplies.
Average Medicare reimbursement rates in non-former CBAs, non-rural areas E1390 E1392 As of January 1, 2025 $ 96.42 $ 47.51 As of January 1, 2024 $ 93.61 $ 46.12 As of January 1, 2023 $ 125.41 $ 46.49 As of January 1, 2022 $ 115.14 $ 43.69 As of April 1, 2021 $ 109.39 $ 42.12 As of January 1, 2021 (retroactively revised March 1, 2021) $ 104.07 $ 40.06 As of January 1, 2020 $ 74.84 $ 36.87 As of January 1, 2019 $ 72.32 $ 35.64 As of January 1, 2018 $ 69.31 $ 38.10 CMS is required to conduct future rounds of competitive bidding, which could reduce reimbursement rates, negatively impact the premium for POCs over other oxygen modalities, or limit beneficiary access to our technologies.
Average Medicare reimbursement rates in non-former CBAs, non-rural areas E1390 E1392 As of January 1, 2026 $ 99.02 $ 48.79 As of January 1, 2025 $ 96.42 $ 47.51 As of January 1, 2024 $ 93.61 $ 46.12 As of January 1, 2023 $ 125.41 $ 46.49 As of January 1, 2022 $ 115.14 $ 43.69 As of April 1, 2021 $ 109.39 $ 42.12 As of January 1, 2021 (retroactively revised March 1, 2021) $ 104.07 $ 40.06 As of January 1, 2020 $ 74.84 $ 36.87 As of January 1, 2019 $ 72.32 $ 35.64 As of January 1, 2018 $ 69.31 $ 38.10 CMS is required to conduct future rounds of competitive bidding, which could reduce reimbursement rates, negatively impact the premium for POCs over other oxygen modalities, or limit beneficiary access to our technologies.
See Note 7 – Income taxes in the notes to our consolidated financial statements in this Annual Report on Form 10-K for additional information and factors that could impact our ability to realize the deferred tax assets.
See Note 6 – Income taxes in the notes to our consolidated financial statements in this Annual Report on Form 10-K for additional information and factors that could impact our ability to realize the deferred tax assets.
Such disruptions or delays may have an adverse effect on our financial condition and results of operations. Failure to comply with anti-bribery, and anti-corruption, including the U.S. Foreign Corrupt Practices Act of 1977, as amended, and similar laws associated with our activities outside of the United States and anti-money-laundering laws could subject us to penalties and other adverse consequences.
Such disruptions or delays may have an adverse effect on our financial condition and results of operations. Failure to comply with anti-bribery, and anti-corruption, including the U.S. Foreign Corrupt Practices Act and similar laws associated with our activities outside of the United States and anti-money-laundering laws could subject us to penalties and other adverse consequences.
We could experience a significant increase in pre-payment reviews of our claims by the Durable Medical Equipment Medicare Administrative Contractors, a private insurance company that processes Medicare claims for durable medical equipment, which could cause substantial delays in the collection of our Medicare accounts receivable as well as related amounts due under supplemental insurance plans. 26 The government has significant resources to audit and ensure oversight of suppliers who care for patients covered by various government healthcare programs.
We could experience a significant increase in pre-payment reviews of our claims by the Durable Medical Equipment Medicare Administrative Contractors, private insurance companies that processes Medicare claims for durable medical equipment, which could cause substantial delays in the collection of our Medicare accounts receivable as well as related amounts due under supplemental insurance plans. 25 The government has significant resources to audit and ensure oversight of suppliers who care for patients covered by various government healthcare programs.
We may need to increase employee wages and benefits in order to attract and retain the personnel necessary to achieve our goals, and our business, operations, and financial results may suffer if we are unable to do so.
We may need to increase employee wages and benefits to attract and retain the personnel necessary to achieve our goals, and our business, operations, and financial results may suffer if we are unable to do so.
The method of assessing conformity under the MDR varies based on the class of the product, and typically requires a combination of self-assessment by the manufacturer and a third-party assessment by a “notified body.” The EU MDR does not apply in Great Britain (England, Scotland and Wales) and the commercialization of medical devices in that territory must comply with rules set out in domestic legislation including the UK Medical Devices Regulations 2002.
The method of assessing conformity under the MDR varies based on the class of the product, and typically requires a combination of self-assessment by the manufacturer and a third-party assessment by a “notified body.” The EU MDR applies in Northern Ireland but does not apply in Great Britain (England, Scotland and Wales) and the commercialization of medical devices in that territory must comply with rules set out in domestic legislation including the UK Medical Devices Regulations 2002.
As the regulatory environment related to information security, data collection and use, and privacy and data protection becomes increasingly rigorous, with new and constantly changing requirements applicable to our business, compliance with those requirements could continue to result in significant costs. 39 Following the GDPR, a number of states in the U.S. have introduced, and in certain cases enacted, privacy legislation imposing operational requirements on U.S. companies similar to the requirements reflected in the GDPR.
As the regulatory environment related to information security, data collection and use, and privacy and data protection becomes increasingly rigorous, with new and constantly changing requirements applicable to our business, compliance with those requirements could continue to result in significant costs. 37 In addition, a number of states in the U.S. have introduced, and in certain cases enacted, privacy legislation imposing operational requirements on U.S. companies similar to the requirements reflected in the GDPR.
If we are not able to find a qualified permanent replacement for these positions, it could have a material adverse effect on our ability to effectively pursue our business strategy. Executive leadership and key technical personnel transitions can be difficult to manage and could cause disruption to our business.
If we are unable to find a qualified permanent replacement for these positions, it could have a material adverse effect on our ability to effectively pursue our business strategy. Executive leadership and key technical personnel transitions can be difficult to manage and could cause disruption to our business.
In addition, any disruption or delay in the shipping of our products, whether domestically or internationally, may have an adverse effect on our financial condition and results of operations. During the years ended December 31, 2024, 2023 and 2022, approximately 34.9%, 28.3% and 26.8%, respectively, of our total revenue was generated from customers located outside of the United States.
In addition, any disruption or delay in the shipping of our products, whether domestically or internationally, may have an adverse effect on our financial condition and results of operations. During the years ended December 31, 2025, 2024, and 2023, approximately 39.8%, 34.9%, and 28.3%, respectively, of our total revenue was generated from customers located outside of the United States.
We have analyzed the potential impact to revenue associated with patients in the capped rental period and have deferred $0 associated with the capped rental period as of December 31, 2024 and December 31, 2023.
We have analyzed the potential impact to revenue associated with patients in the capped rental period and have deferred $0 associated with the capped rental period as of December 31, 2025 and December 31, 2024.
Our success depends upon the skills, experience, and efforts of our senior executives and other key technical personnel, including certain members of our engineering, accounting, and compliance staff as well as our sales and marketing personnel. We have experienced, and may continue to experience, turn-over in our senior executives and other key technical personnel.
Our success depends upon the skills, experience, and efforts of our senior executives and other key technical personnel, including certain members of our engineering, accounting, and compliance staff as well as our sales and marketing personnel. We have experienced, and may continue to experience, turnover in our senior executives and other key technical personnel.
Based on our patient population, we estimate that approximately 51.8% of our potential customers have non-Medicare insurance coverage (including Medicare Advantage plans). Failing to maintain and obtain private payor contracts from private insurance companies and employers and secure in-network provider status could have a material adverse effect on our financial condition and results of operations.
Based on our patient population, we estimate that approximately 58.2% of our potential customers have non-Medicare insurance coverage (including Medicare Advantage plans). Failing to maintain and obtain private payor contracts from private insurance companies and employers and secure in-network provider status could have a material adverse effect on our financial condition and results of operations.
Government and other third-party payors are increasingly attempting to contain health care costs by limiting both coverage and the level of reimbursement for medical products and services. Reimbursement levels may be decreased in the future.
Government and other third-party payors are increasingly attempting to contain health care costs by limiting both coverage and the level of reimbursement for medical products and services. Reimbursement levels may decrease in the future.
Rates in rural areas continue to be based upon a 50/50 blended rates, consistent with CMS' December 2021 final rule described above.
Rates in rural areas continue to be based upon a 50/50 blended rates, consistent with CMS’s December 2021 final rule described above.
While we expended $21.6 million, $20.8 million and $21.9 million for the years ended December 31, 2024, 2023, and 2022, respectively, in research and development efforts, we cannot assure that this level of investment will be sufficient to maintain a competitive advantage in product innovation, which could cause our business to suffer.
While we expended $19.4 million, $21.6 million, and $20.8 million for the years ended December 31, 2025, 2024, and 2023, respectively, in research and development efforts, we cannot assure that this level of investment will be sufficient to maintain a competitive advantage in product innovation, which could cause our business to suffer.
We have insurance coverage in place for certain potential liabilities and costs relating to service interruptions, data corruption, cybersecurity risks, data security incidents and/or network security breaches, but this insurance is limited in amount, subject to a deductible, and may not be adequate to cover us for all costs arising from these incidents.
We have insurance coverage in place for certain potential liabilities and costs relating to service interruptions, data corruption, cybersecurity risks, data security incidents, and network security breaches, but this insurance is limited in amount, subject to deductibles and exclusions, and may not be adequate to cover us for all costs arising from these incidents.
Travel Act, the USA PATRIOT Act, the United Kingdom Bribery Act of 2010 and possibly other anti-corruption, anti-bribery and anti-money laundering laws in the more than sixty-five countries around the world where we have conducted activities and have sold our products.
Travel Act, the USA PATRIOT Act, the United Kingdom Bribery Act of 2010 and other anti-corruption, anti-bribery, and anti-money laundering laws in the more than 70 countries around the world where we have conducted activities and have sold our products.
Also, the Securities Exchange Act of 1934, as amended, or the Exchange Act, requires, among other things, that we file annual, quarterly and current reports with respect to our business and operating results. Our management and other personnel will need to devote a substantial amount of time to compliance with these laws and regulations.
Also, the Exchange Act requires, among other things, that we file annual, quarterly and current reports with respect to our business and operating results. Our management and other personnel will need to devote a substantial amount of time to compliance with these laws and regulations.
The Federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce the referral of an individual to a person for the furnishing of, or in return for purchasing, leasing, ordering, or arranging for or recommending the purchase, lease or order of any healthcare item or service reimbursable under Medicare, Medicaid, or other federal healthcare programs.
The Federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting, or receiving remuneration to induce or reward referrals of individuals to a person for the furnishing of, or in return for purchasing, leasing, ordering, or arranging for or recommending the purchase, lease, or order of any healthcare item or service reimbursable under Medicare, Medicaid, or other federal healthcare programs.
Such a challenge, regardless of the outcome, could have a material adverse effect on our business, business relationships, reputation, financial condition and results of operations.
Any such challenge, regardless of its outcome, could have a material adverse effect on our business, business relationships, reputation, financial condition, and results of operations.
Our capped patients as a percentage of total patients on service was approximately 16.6% as of December 31, 2024 and 13.1% as of December 31, 2023. The percentage of capped patients may fluctuate over time as new patients come on service, patients come off service before and during the capped rental period, and existing patients enter the capped rental period.
Our capped patients as a percentage of total patients on service was approximately 17.6% as of December 31, 2025, and 16.6% as of December 31, 2024. The percentage of capped patients may fluctuate over time as new patients come on service, patients come off service before and during the capped rental period, and existing patients enter the capped rental period.
If the FDA disagrees with our determinations and requires us to submit new 510(k) pre-market notifications or pre-market approval for modifications to our previously cleared products for which we have concluded that new clearances or approvals are unnecessary, we may be required to cease marketing and/or to recall the modified product until we obtain clearance or approval, and we may be subject to significant regulatory penalties or fines. 43 If we fail to comply with FDA or state regulatory requirements, we can be subject to enforcement action.
If the FDA disagrees with our determinations and requires us to submit new 510(k) pre-market notifications or pre-market approval for modifications to our previously cleared products for which we have concluded that new clearances or approvals are unnecessary, we may be required to cease marketing and/or to recall the modified product until we obtain clearance or approval, and we may be subject to significant regulatory penalties or fines.
The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, also created the federal Physician Payments Sunshine Act, which requires applicable manufacturers of drugs, devices, biologicals, and medical supplies covered under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to CMS, information related to payments or other transfers of value made to physicians, as defined, and teaching hospitals, as well as ownership and investment interests in such manufacturer held by physicians and their immediate family members.
The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, also created the federal Physician Payments Sunshine Act, or Sunshine Act, which requires applicable manufacturers of drugs, devices, biologicals, and medical supplies reimbursed by Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to CMS information regarding payments or other transfers of value made to physicians and teaching hospitals, as well as ownership or investment interests held by physicians and their immediate family members.
In addition, providers may reduce or eliminate purchases from us due to our increased focus on building out a prescriber sales team and pursuing rentals directly, which could be in competition with our providers in the United States.
In addition, providers may reduce or eliminate purchases from us due to our focus on maintaining a prescriber sales team and pursuing rentals directly, which could be in competition with other providers in the United States.
In addition, there has been a recent trend of increased federal and state regulation of payments and other transfers of value made to applicable recipients, including physicians. Certain states mandate implementation of compliance programs and/or the tracking and annual reporting of gifts, compensation and other remuneration to physicians and other applicable recipients.
In addition, there has been a trend toward increased federal and state regulation of payments and other transfers of value to healthcare providers, including physicians and other applicable recipients. Certain states mandate implementation of compliance programs and/or the tracking and reporting of gifts, compensation, and other remuneration.
In the event that we become subject to a patent infringement or other intellectual property related lawsuit and if the asserted patents or other intellectual property were upheld as valid and enforceable and we were found to infringe the asserted patents or other intellectual property, or violate the terms of a license to which we are a party, we could be required to do one or more of the following: • cease selling or using any of our products that incorporate the asserted intellectual property, which would adversely affect our revenue; • pay damages for past use of the asserted intellectual property, which may be substantial; • obtain a license from the holder of the asserted intellectual property, which license may not be available on reasonable royalty terms, if at all, and which could reduce profitability; and • redesign or rename, in the case of trademark claims, our products to avoid infringing the intellectual property rights of third parties, which may not be possible and could be costly and time-consuming if it is possible to do so. 51 If we are unable to prevent unauthorized use or disclosure of trade secrets, unpatented know-how and other proprietary information, our ability to compete will be harmed.
In the event that we become subject to a patent infringement or other intellectual property related lawsuit and if the asserted patents or other intellectual property were upheld as valid and enforceable and we were found to infringe the asserted patents or other intellectual property, or violate the terms of a license to which we are a party, we could be required to do one or more of the following: • cease selling or using any of our products that incorporate the asserted intellectual property, which would adversely affect our revenue; • pay damages for past use of the asserted intellectual property, which may be substantial; • obtain a license from the holder of the asserted intellectual property, which license may not be available on reasonable royalty terms, if at all, and which could reduce profitability; and • redesign or rename, in the case of trademark claims, our products to avoid infringing the intellectual property rights of third parties, which may not be possible and could be costly and time-consuming if it is possible to do so.
We rely significantly on reimbursement from Medicare and private payors, including Medicare Advantage plans, Medicaid and patients for our rental revenue. For the year ended December 31, 2024, approximately 56.3% of our rental revenue was derived from Medicare’s traditional fee-for-service reimbursement programs.
We rely significantly on reimbursement from Medicare and private payors, including Medicare Advantage plans, Medicaid and patients for our rental revenue. For the year ended December 31, 2025, approximately 61.9% of our rental revenue was derived from Medicare’s traditional fee-for-service reimbursement programs.
We face significant risks and liability if we fail to comply with the FCPA and other anti-corruption and anti-bribery laws that prohibit companies and their employees, agents, representatives, business partners, and third-party intermediaries, such as distributors or resellers, from authorizing, offering or providing, directly or indirectly, improper payments or benefits to recipients in the public or private sector.
We face significant risks and liability if we fail to comply with the FCPA and other anti-corruption and anti-bribery laws that prohibit companies and their employees, agents, representatives, business partners, and third-party intermediaries, such as distributors or resellers, from authorizing, offering or providing, directly or indirectly, improper payments or benefits to recipients in the public or private sector. 34 We leverage various third parties to sell our products and conduct our business abroad.
The costs to remediate breaches and similar system compromises that do occur could adversely affect our results of operations. We also face risks associated with security breaches affecting third party vendors or customers and others who interact with our data.
The costs of remediating breaches and similar system compromises could adversely affect our results of operations. We also face risks associated with security breaches affecting third party vendors or customers and others who interact with our data.
We assemble our products at our facility in Plano, Texas and through our contract manufacturer in the Czech Republic. No other manufacturing facilities are currently available to us, particularly facilities of the size and scope of our Texas facility.
We assemble our oxygen concentrator products at our facility in Plano, Texas and through our contract manufacturer in the Czech Republic, and our Simeox product at our facility in Montpelier, France. No other manufacturing facilities are currently available to us, particularly facilities of the size and scope of our Texas facility.
For example, for the year ended December 31, 2024, we experienced a net foreign currency loss of $0.2 million, and for the years ended December 31, 2023 and 2022, we experienced a net foreign currency gain of $0.2 million and a loss of $0.8 million, respectively.
For example, for the year ended December 31, 2025, we experienced a net foreign currency gain of $1.3 million, and for the years ended December 31, 2024 and 2023, we experienced a net foreign currency loss of $0.2 million and a gain of $0.2 million, respectively.
These broad market and industry fluctuations may adversely affect the market price of our common stock, regardless of our operating performance. 53 Price volatility over a given period or a low stock price could result in a number of negative outcomes, including, but not limited to: • creating potential limitations on the ability to raise capital through the issuance of equity or equity linked securities; • impacting the value of our equity compensation, which affects our ability to recruit and retain employees; • impairing goodwill or long-lived assets; • difficulty complying with the listing standards of Nasdaq; and • increasing the risk of regulatory proceedings and litigation, including class action securities litigation.
Price volatility over a given period or a low stock price could result in a number of negative outcomes, including, but not limited to: • creating potential limitations on the ability to raise capital through the issuance of equity or equity linked securities; • impacting the value of our equity compensation, which affects our ability to recruit and retain employees; • impairing goodwill or long-lived assets; • difficulty complying with the listing standards of Nasdaq; and • increasing the risk of regulatory proceedings and litigation, including class action securities litigation.
For the years ended December 31, 2024, 2023, and 2022, sales revenue to our top 10 customers accounted for approximately 33.3%, 25.2% and 30.5%, respectively, of our total revenue. Medicare's service reimbursement programs represented more than 10% of our total revenue for the years ended December 31, 2023 and 2022.
For the years ended December 31, 2025, 2024, and 2023, sales revenue to our top 10 customers accounted for approximately 38.9%, 33.3% and 25.2%, respectively, of our total revenue. Medicare's service reimbursement programs represented more than 10% of our total revenue for the year ended December 31, 2023.
As of December 31, 2024, our executive officers, directors and stockholders who owned more than 5% of our outstanding common stock and their respective affiliates beneficially owned or controlled approximately 33.1% of the outstanding shares of our common stock.
As of December 31, 2025, our executive officers, directors, and stockholders who owned more than 5% of our outstanding common stock and their respective affiliates beneficially owned or controlled approximately 23.0% of the outstanding shares of our common stock.
Our business activities involve the use of hazardous materials, which require compliance with environmental and occupational safety laws regulating the use of such materials. If we violate these laws, we could be subject to significant fines, liabilities or other adverse consequences. Our research and development programs as well as our manufacturing operations involve the controlled use of hazardous materials.
Our business activities involve the use of hazardous materials, which require compliance with environmental and occupational safety laws regulating the use of such materials. If we violate these laws, we could be subject to significant fines, liabilities or other adverse consequences.
The majority of states also have statutes or regulations similar to the federal anti-kickback, physician self-referral, and false claims laws, which apply to items or services, reimbursed under Medicaid and other state programs, or in several states, apply regardless of payor. Penalties under these state laws can be comparable to those under their federal equivalents.
In addition, many states have statutes or regulations similar to the federal anti-kickback, physician self-referral, and false claims laws, which apply to items or services reimbursed under Medicaid or other state programs, and in some states may apply regardless of payor. Penalties under these state laws can be comparable to those under their federal counterparts.
In addition, the trading price of our common stock may be highly volatile. During the last twelve months, our common stock traded as high as $13.33 per share and as low as $5.08 per share.
In addition, the trading price of our common stock may be highly volatile. During the last twelve months, our common stock traded as high as $12.91 per share and as low as $5.70 per share.
Medicare’s service reimbursement programs accounted for 56.3%, 67.7% and 77.0% of rental revenue for the years ended December 31, 2024, 2023 and 2022, respectively, and based on total revenue were 9.5%, 13.7% and 11.6% for the years ended December 31, 2024, 2023 and 2022, respectively.
Medicare’s service reimbursement programs accounted for 61.9%, 56.3%, and 67.7% of rental revenue for the years ended December 31, 2025, 2024, and 2023, respectively, and based on total revenue were 9.5%, 9.5%, and 13.7% for the years ended December 31, 2025, 2024, and 2023, respectively.
In particular, one customer represented more than 10% of our net accounts receivable balance with a net accounts receivable balance of $3.3 million as of December 31, 2024. One customer represented more than 10% of our financing receivable balance with a balance of $6.5 million as of December 31, 2024.
In particular, no customer represented more than 10% of our net accounts receivable balance as of December 31, 2025. One customer represented more than 10% of our net accounts receivable balance with a net account receivable balance of $3.3 million as of December 31, 2024.
In addition, the Patient Protection and Affordable Care Act provides that the government may assert that a claim that items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the false claims statutes.
The Patient Protection and Affordable Care Act also provides that claims for items or services resulting from a violation of the federal Anti-Kickback Statute may constitute false or fraudulent claims for purposes of the federal false claims statutes.
An entity that offers to or transfers remuneration to any individual eligible for benefits under Medicare or Medicaid that such entity knows or should know is likely to influence such individual to order or receive from a particular provider, practitioner, or supplier any Medicare or Medicaid payable item or service may be liable for CMPs.
Under this statute, an entity that offers or transfers remuneration to any individual eligible for benefits under Medicare or Medicaid that such entity knows or should know is likely to influence the individual to order or receive items or services reimbursable by Medicare or Medicaid from a particular provider, practitioner, or supplier may be liable for CMPs.
Their effects potentially are far-reaching and may restrict our ability to use personal information in connection with our business operations, require us to modify our data processing practices and policies and incur substantial compliance-related costs and expenses.
Their effects potentially are far-reaching and may restrict our ability to use personal information in connection with our business operations, require us to modify our data processing practices and policies and incur substantial compliance-related costs and expenses. Congress could also pass federal privacy legislation, which may restrict our business operations and require us to incur additional costs for compliance.
In addition, the Patient Protection and Affordable Care Act, among other things, amends the intent requirement of the federal anti-kickback and criminal healthcare fraud statutes to clarify that a person or entity does not need to have actual knowledge of the statute or specific intent to violate it.
In addition, the Patient Protection and Affordable Care Act amended the intent requirements of the federal Anti-Kickback Statute and certain federal healthcare fraud statutes to clarify that a person or entity need not have actual knowledge of the statute or specific intent to violate it.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe have insurance coverage in place for certain potential liabilities and costs relating to cybersecurity risks, data security incidents and/or network security breaches, but this insurance is limited in amount, subject to a deductible, and may not be adequate to cover us for all costs arising from these incidents. 56 Use of Consultants and Advisors: We engage various third-party cybersecurity service providers to assess and enhance our cybersecurity practices and assist with protection and monitoring of our systems and information, including with respect to, network monitoring, endpoint protection, vulnerability assessments and penetration testing.
Biggest changeWe have insurance coverage in place for certain potential liabilities and costs relating to cybersecurity risks, data security incidents and/or network security breaches, but this insurance is limited in amount, subject to a deductible, and may not be adequate to cover us for all costs arising from these incidents.
In particular, the Audit Committee assists the Board in its oversight of management’s responsibility to assess, manage and mitigate risks associated with our business and operational activities, to administer our various compliance programs, in each case including cybersecurity concerns, and to oversee our information technology systems, processes and data.
In particular, the Audit Committee assists the Board in its oversight of management’s responsibility to assess, manage and mitigate risks associated with our business and operational activities, to administer our various compliance programs, in each case including cybersecurity concerns, and to oversee our information technology systems, processes and data. 54 Management has implemented risk management structures, policies and procedures, and Management is responsible for our day-to-day cybersecurity risk management.
The strategic migration of our data centers and infrastructure to secure cloud environments, coupled with the implementation of targeted technical cybersecurity measures, underscores our dedication to establishing foundational security across our users, applications, data, systems, and networks. We have established a comprehensive incident response plan to swiftly address and recover from cybersecurity incidents, minimizing operational impact.
The strategic migration of our data centers and infrastructure to secure cloud environments, coupled with the implementation of targeted technical cybersecurity measures, underscores our dedication to establishing foundational security across our users, applications, data, systems, and networks. We have established a comprehensive incident response plan, designed for timely detection, containment, remediation, and post-incident review.
Management has implemented risk management structures, policies and procedures, and Management is responsible for our day-to-day cybersecurity risk management. Our Chief Data and Information Officer, or CDIO, is responsible for our day-to-day assessment and management of cybersecurity risks. Our Enterprise Enablement function facilitates a cross-departmental approach, ensuring the executive leadership team receives quarterly updates on cybersecurity from various teams.
Our Chief Data and Information Officer, or CDIO, is responsible for our day-to-day assessment and management of cybersecurity risks. Our Information Technology and Cybersecurity function has extensive experience in overseeing cybersecurity programs, managing information security operations, and facilitates a cross-departmental approach, ensuring the executive leadership team receives quarterly updates on cybersecurity from various teams.
We conduct regular trainings and simulations to enhance our team's awareness and preparedness against cyber threats. Biannual penetration testing and regular assessments by external experts validate the effectiveness of our cybersecurity measures. Our proactive approach to addressing identified vulnerabilities affirms the continuous improvement of our security posture.
The plan includes defined escalation thresholds requiring timely notification to senior management and the Audit Committee, including processes for evaluating whether an incident may be material. We conduct regular trainings and simulations to enhance our team's awareness and preparedness against cyber threats. Biannual penetration testing and regular assessments by external experts validate the effectiveness of our cybersecurity measures.
Added
Our proactive approach to addressing identified vulnerabilities affirms the continuous improvement of our security posture.
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Use of Consultants and Advisors: We engage various third-party cybersecurity service providers to assess and enhance our cybersecurity practices and assist with protection and monitoring of our systems and information, including with respect to, network monitoring, endpoint protection, vulnerability assessments and penetration testing.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeIn addition, we lease approximately 1,900 square feet of office space in Huntsville, Alabama and Aurora, Colorado with lease terms of three years; approximately 3,700 square feet of office space in De Meern in the Netherlands with a lease term of five years; approximately 3,600 square feet of office and warehouse space in Montpellier, France under leases that expire in June 2029 and October 2032; and approximately 6,000 square feet of office space in Beverly, Massachusetts with a lease term of three years.
Biggest changeIn addition, we lease approximately 700 square feet of office space in Huntsville, Alabama under a lease that expires in June 2027; 1,200 square feet in Aurora, Colorado with a lease that expires in November 2026; approximately 3,700 square feet of office space in De Meern in the Netherlands with a lease that expires in May 2028; approximately 3,600 square feet of office and warehouse space in Montpellier, France under leases that expire in June 2029 and October 2032; and approximately 6,000 square feet of office space at our corporate headquarters in Beverly, Massachusetts with a lease term of three years that expires in July 2027.
Commencing February 1, 2024 and ending May 31, 2031, the Assignee assumed responsibility for the monthly lease payments. Notwithstanding the Assignee's assumption of lease payments, we remain the primary obligor under the lease to the landlord. 57
Commencing February 1, 2024 and ending May 31, 2031, the Assignee assumed responsibility for the monthly lease payments. Notwithstanding the Assignee's assumption of lease payments, we remain the primary obligor under the lease to the landlord.
ITEM 2. PROPERTIES As of December 31, 2024, we lease approximately 18,000 square feet of office space at our corporate headquarters in Goleta, California under a lease that expires in January 2028 and approximately 154,000 square feet of manufacturing and office space in Plano, Texas under a lease that expires in April 2031.
ITEM 2. PROPERTIES As of December 31, 2025, we lease approximately 18,000 square feet of office space in Goleta, California under a lease that expires in January 2028 and approximately 154,000 square feet of manufacturing and office space in Plano, Texas under a lease that expires in April 2031.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeSTOCKHOLDER RETURN PERFORMANCE GRAPH COMPARISON OF THE 5 YEAR CUMULATIVE TOTAL RETURN Among Inogen, Inc., the S&P Healthcare Equipment and Supplies Index, the Russell 2000 Index and the Nasdaq Composite Index 59 12/31/19 12/31/20 12/31/21 12/31/22 12/31/23 12/31/24 Inogen, Inc. $ 100.00 $ 65.39 $ 49.76 $ 28.85 $ 8.03 $ 13.42 S&P Healthcare Equipment & Supplies (1) 100.00 132.91 136.96 104.99 98.45 103.45 Russell 2000 (2) 100.00 119.96 137.74 109.59 128.14 142.93 Nasdaq Composite (3) $ 100.00 $ 143.64 $ 174.36 $ 116.65 $ 167.30 $ 215.22 (1) The S&P Healthcare Equipment and Supplies Index is a capitalization weighted-average index compiled of healthcare companies in the S&P 500 Index.
Biggest changeSTOCKHOLDER RETURN PERFORMANCE GRAPH COMPARISON OF THE 5 YEAR CUMULATIVE TOTAL RETURN Among Inogen, Inc., the S&P Healthcare Equipment and Supplies Index, the Russell 2000 Index and the Nasdaq Composite Index 12/31/20 12/31/21 12/31/22 12/31/23 12/31/24 12/31/25 Inogen, Inc. $ 100.00 $ 76.10 $ 44.11 $ 12.29 $ 20.52 $ 15.04 S&P Healthcare Equipment & Supplies (1) 100.00 103.04 78.99 74.07 77.83 77.65 Russell 2000 (2) 100.00 114.82 91.35 106.82 119.14 134.40 Nasdaq Composite (3) $ 100.00 $ 122.18 $ 82.43 $ 119.22 $ 154.48 $ 187.14 56 (1) The S&P Healthcare Equipment and Supplies Index is a capitalization weighted-average index compiled of healthcare companies in the S&P 500 Index.
This graph assumes an investment of $100 on December 31, 2019 in each of our common stock, the Nasdaq Composite Index, the S & P Healthcare Equipment and Supplies Index, the Russell 2000 Index and assumes reinvestment of dividends, if any. The stock price performance shown on the graph below is not necessarily indicative of future stock price performance.
This graph assumes an investment of $100 on December 31, 2020 in each of our common stock, the Nasdaq Composite Index, the S & P Healthcare Equipment and Supplies Index, the Russell 2000 Index and assumes reinvestment of dividends, if any. The stock price performance shown on the graph below is not necessarily indicative of future stock price performance.
Securities authorized for issuance under equity compensation plans The information required by this Item regarding equity compensation plans is incorporated by reference to the information set forth in Part III, Item 12 of this Annual Report on Form 10-K. Unregistered sales of equity securities None. Issuer purchases of equity securities None. ITEM 6. [RESE RVED] 60
Securities authorized for issuance under equity compensation plans The information required by this Item regarding equity compensation plans is incorporated by reference to the information set forth in Part III, Item 12 of this Annual Report on Form 10-K. Unregistered sales of equity securities None. Issuer purchases of equity securities None. ITEM 6. [RESE RVED] 57
The following graph compares the performance of our common stock for the periods indicated with the performance of the S&P Healthcare and Supplies Index, the Russell 2000 Index, and the Nasdaq Composite Index from December 31, 2019 to December 31, 2024.
The following graph compares the performance of our common stock for the periods indicated with the performance of the S&P Healthcare and Supplies Index, the Russell 2000 Index, and the Nasdaq Composite Index from December 31, 2020 to December 31, 2025.
(2) The Russell 2000 Index is a small-cap stock market index of the bottom 2,000 stocks in the Russell 3000 Index. (3) The Nasdaq Composite is a market-value weighted index of all common stocks listed on the Nasdaq. Stockholders As of February 21, 2025, there were 8 registered stockholders of record for our common stock.
(2) The Russell 2000 Index is a small-cap stock market index of the bottom 2,000 stocks in the Russell 3000 Index. (3) The Nasdaq Composite is a market-value weighted index of all common stocks listed on the Nasdaq. Stockholders As of February 20, 2026, there were 10 registered stockholders of record for our common stock.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeDomestic direct-to-consumer rentals decreased 11.1% for the year ended December 31, 2024 compared to the year ended December 31, 2023, primarily related to a higher mix of lower private-payor reimbursement rates. 66 Cost of revenue and gross profit Years ended December 31, Change 2024 vs. 2023 % of Revenue (dollar amounts in thousands) 2024 2023 $ % 2024 2023 Cost of sales revenue $ 148,655 $ 158,636 $ (9,981 ) -6.3 % 44.3 % 50.3 % Cost of rental revenue 32,309 30,325 1,984 6.5 % 9.6 % 9.6 % Total cost of revenue $ 180,964 $ 188,961 $ (7,997 ) -4.2 % 53.9 % 59.9 % Gross profit - sales revenue $ 130,101 $ 92,971 $ 37,130 39.9 % 38.8 % 29.4 % Gross profit - rental revenue 24,640 33,728 (9,088 ) -26.9 % 7.3 % 10.7 % Total gross profit $ 154,741 $ 126,699 $ 28,042 22.1 % 46.1 % 40.1 % Gross margin percentage - sales revenue 46.7 % 37.0 % Gross margin percentage - rental revenue 43.3 % 52.7 % Total gross margin percentage 46.1 % 40.1 % Cost of sales revenue decreased $10.0 million for the year ended December 31, 2024 from the year ended December 31, 2023, a decrease of 6.3%, due primarily to lower premiums paid for raw material components, partially offset by an increase in the numbers of systems sold.
Biggest changeCost of revenue and gross profit Years ended December 31, Change 2025 vs. 2024 % of Revenue (dollar amounts in thousands) 2025 2024 $ % 2025 2024 Cost of sales revenue $ 163,837 $ 148,655 $ 15,182 10.2 % 47.0 % 44.3 % Cost of rental revenue 30,566 32,309 (1,743 ) -5.4 % 8.8 % 9.6 % Total cost of revenue $ 194,403 $ 180,964 $ 13,439 7.4 % 55.8 % 53.9 % Gross profit - sales revenue $ 131,467 $ 130,101 $ 1,366 1.0 % 37.7 % 38.8 % Gross profit - rental revenue 22,798 24,640 (1,842 ) -7.5 % 6.5 % 7.3 % Total gross profit $ 154,265 $ 154,741 $ (476 ) -0.3 % 44.2 % 46.1 % Gross margin percentage - sales revenue 44.5 % 46.7 % Gross margin percentage - rental revenue 42.7 % 43.3 % Total gross margin percentage 44.2 % 46.1 % Cost of sales revenue increased $15.2 million, or 10.2%, for the year ended December 31, 2025 from the year ended December 31, 2024 due primarily to an increase in the number of systems sold.
Below, we have provided a reconciliation of EBITDA and Adjusted EBITDA to our net loss, the most directly comparable financial measure calculated and presented in accordance with U.S. GAAP. EBITDA and Adjusted EBITDA should not be considered alternatives to net loss, or any other measure of financial performance calculated and presented in accordance with U.S. GAAP.
Below, we have provided a reconciliation of EBITDA and Adjusted EBITDA to our net loss, the most directly comparable financial measure calculated and presented in accordance with U.S. GAAP. EBITDA and Adjusted EBITDA should not be considered alternatives to a net loss, or any other measure of financial performance calculated and presented in accordance with U.S. GAAP.
Some of these limitations are: • EBITDA and Adjusted EBITDA do not reflect our cash expenditures for capital equipment or other contractual commitments; • although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and EBITDA and Adjusted EBITDA do not reflect capital expenditure requirements for such replacements; • EBITDA and Adjusted EBITDA do not reflect changes in, or cash requirements for, our working capital needs; • Adjusted EBITDA does not include changes in fair value of earnout liability related to our acquisitions; • Adjusted EBITDA does not include acquisition-related expenses, whether the acquisition was consummated or not pursued; • Adjusted EBITDA does not include costs associated with workforce reductions and associated costs and other restructuring-related activities; • goodwill impairment; and • other companies, including companies in our industry, may calculate EBITDA and Adjusted EBITDA measures differently, which reduces their usefulness as a comparative measure.
Some of these limitations are: • EBITDA and Adjusted EBITDA do not reflect our cash expenditures for capital equipment or other contractual commitments; • although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and EBITDA and Adjusted EBITDA do not reflect capital expenditure requirements for such replacements; • EBITDA and Adjusted EBITDA do not reflect changes in, or cash requirements for, our working capital needs; • Adjusted EBITDA does not include changes in fair value of earnout liability related to our acquisitions; • Adjusted EBITDA does not include acquisition-related expenses, whether the acquisition was consummated or not pursued; 68 • Adjusted EBITDA does not include costs associated with workforce reductions and associated costs and other restructuring-related activities; • goodwill impairment; and • other companies, including companies in our industry, may calculate EBITDA and Adjusted EBITDA measures differently, which reduces their usefulness as a comparative measure.
We used a discounted cash flow analysis based on Level 3 inputs and determined that the goodwill carrying amount exceeded its fair value and, as such, an impairment charge of $32.9 million was incurred in the quarter ended September 30, 2023. Total accumulated impairment losses were $32.9 million as of December 31, 2023 and 2024.
We used a discounted cash flow analysis based on Level 3 inputs and determined that the goodwill carrying amount exceeded its fair value and, as such, an impairment charge of $32.9 million was incurred in the quarter ended September 30, 2023. Total accumulated impairment losses were $32.9 million as of December 31, 2024 and 2025.
Our future capital requirements will also depend on many additional factors, including those set forth in the section of this Annual Report on Form 10-K entitled “Risk Factors.” 69 If we require additional funds in the future, we may not be able to obtain such funds on acceptable terms, or at all.
Our future capital requirements will also depend on many additional factors, including those set forth in the section of this Annual Report on Form 10-K entitled “Risk Factors.” If we require additional funds in the future, we may not be able to obtain such funds on acceptable terms, or at all.
Net cash used in operating activities for the year ended December 31, 2023 consisted primarily of our net loss of $102.4 million, partially offset by non-cash adjustment items such as impairment charges of $32.9 million, depreciation of equipment and leasehold improvements and amortization of intangibles of $18.2 million, provision for sales returns and doubtful accounts of $10.7 million, stock-based compensation expense of $7.4 million, change in fair value of earnout liability of $6.8 million, net loss on disposal of rental assets and other assets of $4.5 million, provision for inventory obsolescence and other inventory losses of $2.7 million, and loss on purchase commitments of $2.1 million.
Net cash used in operating activities for the year ended December 31, 2023 consisted primarily of our net loss of $102.4 million, partially offset by non-cash adjustment items such as impairment charges of $32.9 million, depreciation of equipment and leasehold improvements and amortization of intangibles of $18.2 million, provision for sales returns and credit losses of $10.7 million, stock-based compensation expense of $7.4 million, change in fair value of earnout liability of $6.8 million, net loss on disposal of rental assets and other assets of $4.5 million, provision for inventory obsolescence and other inventory losses of $2.7 million, and loss on purchase commitments of $2.1 million.
Revenue from product sales is generally recognized upon shipment of the product but is deferred for certain transactions when control has not yet transferred to the customer. 61 Our product is generally sold with a right of return and we may provide other incentives, which are accounted for as variable consideration when estimating the amount of revenue to recognize.
Revenue from product sales is generally recognized upon shipment of the product but is deferred for certain transactions when control has not yet transferred to the customer. 58 Our product is generally sold with a right of return and we may provide other incentives, which are accounted for as variable consideration when estimating the amount of revenue to recognize.
Technology and customer relationship intangibles are amortized using the straight-line method. 63 Recent accounting pronouncements Refer to Note 2 – Summary of significant accounting policies in the notes to the consolidated financial statements included in Part IV, Item 15 in this Annual Report on Form 10-K for further discussion.
Technology and customer relationship intangibles are amortized using the straight-line method. 60 Recent accounting pronouncements Refer to Note 2 – Summary of significant accounting policies in the notes to the consolidated financial statements included in Part IV, Item 15 in this Annual Report on Form 10-K for further discussion.
Amounts related to the capped rental period have not been material in the periods presented. 62 The lease term begins on the date products are shipped to patients and are recorded at amounts estimated to be received under reimbursement arrangements with third-party payors, including Medicare, private payors, and Medicaid.
Amounts related to the capped rental period have not been material in the periods presented. 59 The lease term begins on the date products are shipped to patients and are recorded at amounts estimated to be received under reimbursement arrangements with third-party payors, including Medicare, private payors, and Medicaid.
We additionally have an Inogen base of operations for sales and customer service in the Netherlands along with sales representatives based in focus European countries, and use a contract manufacturer, Foxconn, located in the Czech Republic to support the majority of our European sales volumes.
We additionally have an Inogen base of operations for sales and customer service in the Netherlands along with sales representatives based in focused European countries, and use a contract manufacturer, Foxconn, located in the Czech Republic to support the majority of our European sales volumes.
For the year ended December 31, 2023, net cash provided by financing activities consisted of $1.5 million from the proceeds received from stock options that were exercised and purchases under our employee stock purchase program, partially offset by the payment of employment taxes related to the vesting of restricted stock awards and restricted stock units of $0.5 million.
For the year ended December 31, 2024, net cash provided by financing activities consisted of $0.8 million from the proceeds received from purchases under our employee stock purchase program, partially offset by the payment of employment taxes related to the vesting of restricted stock units of $0.5 million. 66 For the year ended December 31, 2023, net cash provided by financing activities consisted of $1.5 million from the proceeds received from stock options that were exercised and purchases under our employee stock purchase program, partially offset by the payment of employment taxes related to the vesting of restricted stock awards and restricted stock units of $0.5 million.
Net cash provided by operating activities for the year ended December 31, 2024 consisted primarily of non-cash adjustment items such as depreciation of equipment and leasehold improvements and amortization of intangibles of $21.0 million, provision for sales returns and doubtful accounts of $10.9 million, stock-based compensation expense of $7.4 million, net loss on disposal of rental assets and other assets of $4.5 million, and change in fair value of earnout liability of $3.0 million.
Net cash provided by operating activities for the year ended December 31, 2024 consisted primarily of non-cash adjustment items such as depreciation of equipment and leasehold improvements and amortization of intangibles of $21.0 million, provision for sales returns and credit losses of $10.9 million, stock-based compensation expense of $7.4 million, net loss on disposal of rental assets and other assets of $4.5 million, and change in fair value of earnout liability of $3.0 million.
In addition, if our operating performance during the next twelve months is below our expectations, our liquidity and ability to operate our business could be adversely affected.
In addition, if our operating performance during the next 12 months is below our expectations, our liquidity and ability to operate our business could be adversely affected.
We are continuing to focus on the patient first initiative, which involves cross-training of sales representatives to execute cash sales and insurance rental. Additionally, we expect to continue to focus on increased productivity driven by improved sales management discipline, insights-informed tools, and optimized patient lead generation with a downsized direct-to-consumer sales team. • Optimize our rental revenues.
We are continuing to focus on the patient first initiative, which involves cross-training of sales representatives to execute cash sales and insurance rental transactions. Additionally, we expect to continue to focus on increased productivity driven by improved sales management discipline, insights-informed tools, and optimized patient lead generation with an optimized direct-to-consumer sales team. • Optimize our rental revenues.
Over the past several years our cash flows from customer collections have remained consistent and our annual cash provided by operating activities has generally been a significant source of capital to the business. 71 Contractual obligations The following table reflects a summary of our contractual obligations as of December 31, 2024.
Over the past several years our cash flows from customer collections have remained consistent and our annual cash provided by operating activities has generally been a significant source of capital to the business. 67 Contractual obligations The following table reflects a summary of our contractual obligations as of December 31, 2025.
Overview We are a medical technology company that primarily develops, manufactures, and markets innovative respiratory market products, including our portable oxygen therapy solutions for patients with chronic respiratory conditions as well as our Simeox product for airway clearance treatment.
Overview We are a medical technology company that primarily develops, manufactures, and markets innovative respiratory market products, including our portable and stationary oxygen therapy solutions for patients with chronic respiratory conditions as well as our Simeox product for airway clearance treatment and Aurora masks for CPAP therapy.
Use of funds Our principal uses of cash are funding our new rental asset deployments and other capital purchases, operations, and other working capital requirements and, from time-to-time, the acquisition of businesses.
Use of funds Our principal uses of cash are funding our new rental asset deployments and other capital purchases, operations, and other working capital requirements and, from time-to-time, the acquisition of businesses and the payment of the earnout liability.
Gross margin on rental revenue decreased to 43.3% for the year ended December 31, 2024 from 52.7% for the year ended December 31, 2023, primarily due to a higher mix shift of private-payor reimbursement, lower net revenue per rental patient as a result of a decrease in the percentage of patients billed compared to total patients on service, and higher service costs.
Gross margin on rental revenue decreased to 42.7% for the year ended December 31, 2025 from 43.3% for the year ended December 31, 2024, primarily due to a higher mix shift of private-payor reimbursement and lower net revenue per rental patient as a result of a decrease in total patients on service.
Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 1, 2024, which discussion is incorporated herein by reference and which is available free of charge on the SECs website at www.sec.gov .
Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 28, 2025, which discussion is incorporated herein by reference and which is available free of charge on the SEC’s website at www.sec.gov .
We incurred $21.6 million, $20.8 million and $21.9 million in 2024, 2023 and 2022, respectively, in research and development expenses, and we intend to continue to make similar investments in the foreseeable future.
We incurred $19.4 million, $21.6 million and $20.8 million in 2025, 2024 and 2023, respectively, in research and development expenses, and we intend to continue to make similar investments in the foreseeable future.
In order to take advantage of these international markets, we have partnered with distributors who serve key customers in those markets.
In order to take advantage of these international markets, we have partnered with distributors and national and international HMEs who serve key customers and patients in those markets.
For the years ended December 31, 2024, 2023 and 2022, we received $0.8 million, $1.5 million and $1.7 million, respectively, in proceeds related to stock option exercises and our employee stock purchase plan. As of December 31, 2024, we had a financing receivable of $6.5 million, which consisted of $1.8 million in current assets and $4.7 million in noncurrent assets.
For the years ended December 31, 2024 and 2023, we received $0.8 million and $1.5 million, respectively, in proceeds related to our ESPP and stock option exercises. As of December 31, 2025, we had a financing receivable of $4.7 million, which consisted of $1.4 million in current assets and $3.3 million in noncurrent assets.
We derive the majority of our revenue from the sale and rental of our Inogen One and Rove systems and related accessories to patients, insurance carriers, home healthcare providers, resellers, and distributors, including our private label collaborator.
We derive the majority of our revenue from the sale and rental of our portable oxygen concentrator systems and related accessories to patients, insurance carriers, home healthcare providers, resellers, and distributors, including our private label collaborator.
International business-to-business sales increased 31.1% for the year ended December 31, 2024 compared to the year ended December 31, 2023, primarily due to an increase in demand from our partners in Europe and new customers.
International sales increased 18.4% for the year ended December 31, 2025 compared to the year ended December 31, 2024, primarily due to an increase in demand from our partners in Europe and new customers.
Liquidity and capital resources As of December 31, 2024, we had cash and cash equivalents of $113.8 million, which consisted of highly liquid investments with a maturity of three months or less.
Liquidity and capital resources As of December 31, 2025, we had cash and cash equivalents of $103.7 million, which consisted of highly liquid investments with a maturity of three months or less.
For the year ended December 31, 2022, we invested $21.2 million in the production and purchase of rental assets and other property and equipment, partially offset by $10.0 million we received in maturities of marketable securities.
For the year ended December 31, 2025, we invested $29.8 million in the purchase of marketable securities and $10.4 million in the production and purchase of rental assets and other property and equipment, partially offset by $14.0 million we received from maturities of marketable securities.
Sources of funds Our net cash provided by operating activities in the year ended December 31, 2024 was $5.9 million compared to net cash used in operating activities of $3.2 million in the year ended December 31, 2023. As of December 31, 2024, we had cash and cash equivalents of $113.8 million.
Our net cash used in operating activities in the year ended December 31, 2025 was $11.2 million compared to net cash provided by $5.9 million in the year ended December 31, 2024. As of December 31, 2025, we had cash and cash equivalents of $103.7 million.
See the section titled “Fair Value of Earnout Liability” in the notes to consolidated financial statements included in this Annual Report on Form 10-K for further discussion. Non-GAAP financial measures EBITDA and Adjusted EBITDA are financial measures that are not calculated in accordance with U.S. GAAP.
For additional description of contractual obligations and commitments, see the section titled “Commitments and Contingencies” in the notes to consolidated financial statements included in this Annual Report on Form 10-K. Non-GAAP financial measures EBITDA and Adjusted EBITDA are financial measures that are not calculated in accordance with U.S. GAAP.
The following tables show a summary of our cash flows and working capital for the periods and as of the dates indicated: (amounts in thousands) Years ended December 31, Summary of consolidated cash flows 2024 2023 2022 Cash provided by (used in) operating activities $ 5,914 $ (3,234 ) $ (37,532 ) Cash used in investing activities (13,975 ) (59,315 ) (10,877 ) Cash provided by financing activities 265 960 380 Effect of exchange rates on cash (281 ) 67 (481 ) Net decrease in cash and cash equivalents $ (8,077 ) $ (61,522 ) $ (48,510 ) (amounts in thousands) December 31, Summary of working capital 2024 2023 Total current assets $ 185,451 $ 207,067 Total current liabilities 76,686 72,496 Net working capital $ 108,765 $ 134,571 Operating activities Historically, we derive operating cash flows from cash collected from the sales and rental of our products and services.
The following tables show a summary of our cash flows and working capital for the periods and as of the dates indicated: (amounts in thousands) Years ended December 31, Summary of consolidated cash flows 2025 2024 2023 Cash provided by (used in) operating activities $ (11,216 ) $ 5,914 $ (3,234 ) Cash used in investing activities (26,209 ) (13,975 ) (59,315 ) Cash provided by financing activities 24,182 265 960 Effect of exchange rates on cash 846 (281 ) 67 Net decrease in cash and cash equivalents $ (12,397 ) $ (8,077 ) $ (61,522 ) (amounts in thousands) December 31, Summary of working capital 2025 2024 Total current assets $ 198,299 $ 185,451 Total current liabilities 63,535 76,686 Net working capital $ 134,764 $ 108,765 65 Operating activities Historically, we derive operating cash flows from cash collected from the sales and rental of our products and services.
We are also focused on expanding in the Asia-Pacific region and Latin America where we have added sales representatives to set up new distributors in promising markets. 64 • Improve our domestic direct-to-consumer sales and prescriber sales teams and increase productivity.
We are also focused on expanding in the Asia-Pacific region and Latin America for which we have added sales representatives to continue our expansion in those promising markets. 61 • Improve our domestic direct-to-consumer sales and prescriber sales teams and increase productivity.
Our Simeox product is a technology-enabled airway clearance and mucus management device predominantly aimed at serving patients with bronchiectasis which is a condition that presents as the lung’s bronchi are damaged and widened in patients with cystic fibrosis or COPD. Simeox is used in pulmonary rehabilitation centers as well as at home.
Our Simeox product is a technology-enabled airway clearance and mucus management device predominantly aimed at serving patients requiring airway clearance, such as those with bronchiectasis – a condition characterized by damaged and widened bronchi that can occur in patients with cystic fibrosis, COPD, or other respiratory conditions. Simeox is used in pulmonary rehabilitation centers as well as at home.
Cost of rental revenue included $12.6 million of rental asset depreciation for the year ended December 31, 2024 compared to $12.9 million for the year ended December 31, 2023. Gross margin on sales revenue increased to 46.7% for the year ended December 31, 2024 from 37.0% for the year ended December 31, 2023.
Cost of rental revenue included $11.8 million of rental asset depreciation for the year ended December 31, 2025 compared to $12.6 million for the year ended December 31, 2024. Gross margin on sales revenue decreased to 44.5% for the year ended December 31, 2025 from 46.7% for the year ended December 31, 2024.
Comparison of years ended December 31, 2023 and 2022 A discussion of changes in our results of operations during the year ended December 31, 2023 compared to the year ended December 31, 2022 has been omitted from this Annual Report on Form 10-K but may be found in “Item 7.
The decrease in net loss was primarily related to an increase in sales revenue and lower operating expense. 64 Comparison of years ended December 31, 2024 and 2023 A discussion of changes in our results of operations during the year ended December 31, 2024 compared to the year ended December 31, 2023 has been omitted from this Annual Report on Form 10-K but may be found in “Item 7.
GAAP measure, for each of the periods indicated: (amounts in thousands) Years ended December 31, Non-GAAP EBITDA and Adjusted EBITDA 2024 2023 2022 Net loss (GAAP) $ (35,888 ) $ (102,449 ) $ (83,772 ) Non-GAAP adjustments: Interest income, net (5,190 ) (6,574 ) (2,837 ) Provision (benefit) for income taxes (588 ) 105 504 Depreciation and amortization 21,004 18,152 23,514 EBITDA (non-GAAP) (20,662 ) (90,766 ) (62,591 ) Stock-based compensation 7,397 7,427 12,283 Acquisition-related expenses 784 2,413 — Restructuring-related and other charges — 3,426 — Impairment charges — 32,894 — Change in fair value of earnout liability 3,000 6,822 (15,386 ) Loss on disposal of intangible asset — — 52,161 Adjusted EBITDA (non-GAAP) $ (9,481 ) $ (37,784 ) $ (13,533 ) 73
GAAP measure, for each of the periods indicated: (amounts in thousands) Years ended December 31, Non-GAAP EBITDA and Adjusted EBITDA 2025 2024 2023 Net loss (GAAP) $ (22,747 ) $ (35,888 ) $ (102,449 ) Non-GAAP adjustments: Interest income, net (4,385 ) (5,190 ) (6,574 ) (Benefit) provision for income taxes (632 ) (588 ) 105 Depreciation and amortization 20,659 21,004 18,152 EBITDA (non-GAAP) (7,105 ) (20,662 ) (90,766 ) Stock-based compensation 8,014 7,397 7,427 Acquisition-related expenses — 784 2,413 Restructuring-related and other charges — — 3,426 Impairment charges — — 32,894 Change in fair value of earnout liability — 3,000 6,822 Legal and settlement expenses 1,784 — — Adjusted EBITDA (non-GAAP) $ 2,693 $ (9,481 ) $ (37,784 )
The increase was primarily attributable to higher international and domestic business-to-business sales. We sold approximately 157,500 oxygen systems during the year ended December 31, 2024 compared to approximately 130,500 oxygen systems sold during the year ended December 31, 2023, an increase of 20.7%.
The increase was primarily attributable to higher demand in international sales. We sold approximately 189,400 oxygen systems during the year ended December 31, 2025 compared to approximately 157,500 oxygen systems sold during the year ended December 31, 2024, an increase of 20.3%.
Payments due by period (amounts in thousands) Less than 1-3 3-5 More than Contractual Obligations Total 1 year years years 5 years Operating leases - properties and other (1) $ 21,126 $ 3,336 $ 7,255 $ 6,271 $ 4,264 Purchase obligations (2) 58,400 58,400 — — — Total $ 79,526 $ 61,736 $ 7,255 $ 6,271 $ 4,264 (1) We lease manufacturing and office space in Plano, TX, Goleta, CA, Smyrna, TN, Huntsville, AL, Aurora, CO, Beverly, MA, De Meern, Netherlands and Montpellier, France with terms that expire between 2025 and 2031 and miscellaneous office and processing equipment in Texas and California with terms expiring between 2025 and 2028.
Payments due by period (amounts in thousands) Less than 1-3 3-5 More than Contractual Obligations Total 1 year years years 5 years Operating leases - properties and other (1) $ 18,909 $ 3,654 $ 7,303 $ 6,668 $ 1,284 Purchase obligations (2) 62,163 62,163 — — — Total $ 81,072 $ 65,817 $ 7,303 $ 6,668 $ 1,284 (1) We lease manufacturing and office space in Plano, TX, Goleta, CA, Huntsville, AL, Aurora, CO, Beverly, MA, De Meern, Netherlands and Montpellier, France with terms that expire between 2026 and 2031 and miscellaneous office and processing equipment in Texas and California with terms expiring between 2026 and 2028.
Investing activities Net cash used in investing activities generally includes the production and purchase of rental assets, property, plant and equipment, acquisitions, and intangibles to support our expanding business as well as maturities (purchases) of marketable securities. 70 For the year ended December 31, 2024, we invested $32.7 million in the purchase of marketable securities, $15.0 million in the production and purchase of rental assets and other property and equipment, and $2.1 million in intangible assets, partially offset by $35.5 million we received from maturities of marketable securities.
For the year ended December 31, 2024, we invested $32.7 million in the purchase of marketable securities, $15.0 million in the production and purchase of rental assets and other property and equipment, and $2.1 million in intangible assets, partially offset by $35.5 million we received from maturities of marketable securities.
In the year ended December 31, 2024, sales in Europe as a percentage of total international sales revenue slightly decreased to 85.0% versus 85.3% in 2023.
In the year ended December 31, 2025, sales in Europe as a percentage of total international sales revenue remained unchanged at 85.0% compared to the year ended December 31, 2024.
General and administrative expense Years ended December 31, Change 2024 vs. 2023 % of Revenue (dollar amounts in thousands) 2024 2023 $ % 2024 2023 General and administrative expense $ 72,578 $ 75,260 $ (2,682 ) -3.6 % 21.6 % 23.8 % General and administrative expense decreased $2.7 million for the year ended December 31, 2024, from the year ended December 31, 2023, a decrease of 3.6%, primarily due to decreases of $3.8 million in the change in fair value of the earnout liability, $3.4 million in restructuring-related costs, $2.5 million in chief executive officer transition costs and $1.6 million in acquisition-related expenses.
General and administrative expense Years ended December 31, Change 2025 vs. 2024 % of Revenue (dollar amounts in thousands) 2025 2024 $ % 2025 2024 General and administrative expense $ 67,381 $ 72,578 $ (5,197 ) -7.2 % 19.3 % 21.6 % General and administrative expense decreased $5.2 million, or 7.2%, for the year ended December 31, 2025, from the year ended December 31, 2024, primarily due to decreases of $3.0 million in the change in fair value of the earnout liability, $2.0 million in bad debt expense, and $0.8 million in acquisition-related expenses, respectively.
In addition, we believe EBITDA and Adjusted EBITDA and similar measures are widely used by investors, securities analysts, ratings agencies, and other parties in evaluating companies in our industry as a measure of financial performance and debt-service capabilities. 72 Our uses of EBITDA and Adjusted EBITDA have limitations as analytical tools and should not be considered in isolation or as a substitute for analysis of our results as reported under U.S.
In addition, we believe EBITDA and Adjusted EBITDA and similar measures are widely used by investors, securities analysts, ratings agencies, and other parties in evaluating companies in our industry as a measure of financial performance and debt-service capabilities.
Net loss Years ended December 31, Change 2024 vs. 2023 % of Revenue (dollar amounts in thousands) 2024 2023 $ % 2024 2023 Net loss $ (35,888 ) $ (102,449 ) $ 66,561 65.0 % -10.7 % -32.5 % Net loss decreased $66.6 million for the year ended December 31, 2024 from the year ended December 31, 2023, or a decrease of 65.0%.
Net loss Years ended December 31, Change 2025 vs. 2024 % of Revenue (dollar amounts in thousands) 2025 2024 $ % 2025 2024 Net loss $ (22,747 ) $ (35,888 ) $ 13,141 36.6 % -6.5 % -10.7 % Net loss decreased $13.1 million, or 36.6%, for the year ended December 31, 2025 from the year ended December 31, 2024.
Net cash used in operating activities for the year ended December 31, 2022 consisted primarily of our net loss of $83.8 million and the non-cash add back for change in fair value of the earnout liability of $15.4 million, partially offset by non-cash adjustment items such as loss on disposal of intangible asset of $52.2 million, depreciation of equipment and leasehold improvements and amortization of intangibles of $23.5 million, provision for sales returns and doubtful accounts of $13.0 million, stock-based compensation expense of $12.3 million, net loss on disposal of rental equipment and other fixed assets of $3.1 million, and provision for inventory obsolescence and other inventory losses of $2.4 million.
Net cash used in operating activities for the year ended December 31, 2025 consisted primarily of our net loss of $22.7 million, partially offset by non-cash adjustment items of depreciation of equipment and leasehold improvements and amortization of intangibles of $20.7 million, stock-based compensation expense of $8.0 million, provision for sales returns and credit losses of $6.4 million, and net loss on disposal of rental assets and other assets of $3.2 million.
Our principal use of our funds for liquidity and capital resources in the year ended December 31, 2024 consisted of cash used in investing activities of $17.1 million for additional rental equipment, other property, plant and equipment and intangible assets, partially offset by cash provided by operating activities of $5.9 million and $2.8 million for net maturities of marketable securities.
Our principal use of our funds for liquidity and capital resources in the year ended December 31, 2025 consisted of cash used in investing activities of $29.8 million for the purchase of marketable securities, $10.4 million in the production and purchase of rental assets and other property and equipment and cash used in operating activities of $11.2 million.
We continued to record a valuation allowance on the use of deferred tax assets in the current and prior periods. The decrease was attributable to foreign taxes. Our effective tax rate for the year ended December 31, 2024 increased compared to the year ended December 31, 2023, primarily due to foreign taxes.
We continued to record a valuation allowance on the use of deferred tax assets in the current and prior periods. The decrease was attributable to lower foreign and state taxes.
For the year ended December 31, 2024, net cash provided by financing activities consisted of $0.8 million from the proceeds received from purchases under our employee stock purchase program, partially offset by the payment of employment taxes related to the vesting of restricted stock units of $0.5 million.
For the year ended December 31, 2025, net cash provided by financing activities consisted of $27.2 million of proceeds from issuance of common stock pursuant to the securities purchase agreement with Yuwell, $1.0 million of proceeds received from purchases under our ESPP, partially offset by the payment of the earnout liability of $3.2 million and employment taxes related to the vesting of RSUs of $0.8 million.
In particular, international conflicts could create instability, have and may further result in sanctions, tariffs, and other measures that restrict international trade and may negatively affect our business operations and results. For additional information on risk factors that could impact our results, please refer to the sections entitled “Risk Factors” in this Annual Report on Form 10-K.
For additional information on risk factors that could impact our results, please refer to the sections entitled “Risk Factors” in this Annual Report on Form 10-K.
Research and development expense Years ended December 31, Change 2024 vs. 2023 % of Revenue (dollar amounts in thousands) 2024 2023 $ % 2024 2023 Research and development expense $ 21,610 $ 20,840 $ 770 3.7 % 6.4 % 6.6 % Research and development expense increased $0.8 million for the year ended December 31, 2024 from the year ended December 31, 2023, representing an increase of 3.7%.
Research and development expense Years ended December 31, Change 2025 vs. 2024 % of Revenue (dollar amounts in thousands) 2025 2024 $ % 2025 2024 Research and development expense $ 19,399 $ 21,610 $ (2,211 ) -10.2 % 5.6 % 6.4 % Research and development expense decreased $2.2 million, or 10.2%, for the year ended December 31, 2025 from the year ended December 31, 2024.
The increase was primarily due to lower material cost premiums associated with open-market purchases of semiconductor chips used in our POCs and operational efficiencies, partially offset by a change in sales mix towards increased business-to-business sales.
The decrease was driven by customer mix and higher cost premiums associated with open-market purchases of semiconductor chips used in our POCs, partially offset by lower warranty expense.
The decrease was primarily attributable to a decrease of $1.4 million in interest income due to the lower interest rate environment. 68 Income tax expense (benefit) Years ended December 31, Change 2024 vs. 2023 % of Revenue (dollar amounts in thousands) 2024 2023 $ % 2024 2023 Income tax expense (benefit) $ (588 ) $ 105 $ (693 ) -660.0 % -0.2 % 0.0 % Effective income tax rate 1.6 % -0.1 % Income tax expense (benefit) decreased $0.7 million for the year ended December 31, 2024 from the year ended December 31, 2023.
Income tax benefit Years ended December 31, Change 2025 vs. 2024 % of Revenue (dollar amounts in thousands) 2025 2024 $ % 2025 2024 Income tax benefit $ (632 ) $ (588 ) $ (44 ) 7.5 % -0.2 % -0.2 % Effective income tax rate 2.7 % 1.6 % Income tax benefit increased less than $0.1 million, or 7.5%, for the year ended December 31, 2025 from the year ended December 31, 2024.
Rental revenue decreased $7.1 million for the year ended December 31, 2024 from the year ended December 31, 2023, or a decrease of 11.1% from the prior year. The decrease in rental revenue was primarily related to a higher mix of lower private-payor reimbursement rates.
Cost of rental revenue decreased $1.7 million, or 5.4%, for the year ended December 31, 2025 from the year ended December 31, 2024. The decrease in cost of rental revenue was primarily attributable to a decrease in logistics costs and depreciation.
This was due primarily to a $2.3 million increase in amortization costs of intangible assets related to the Physio-Assist acquisition, partially offset by a $1.6 million decrease in product development costs. 67 Sales and marketing expense Years ended December 31, Change 2024 vs. 2023 % of Revenue (dollar amounts in thousands) 2024 2023 $ % 2024 2023 Sales and marketing expense $ 103,069 $ 107,091 $ (4,022 ) -3.8 % 30.7 % 33.9 % Sales and marketing expense decreased $4.0 million for the year ended December 31, 2024 from the year ended December 31, 2023, a decrease of 3.8%.
This decrease was due primarily to a $2.2 million decrease in consulting expense. 63 Sales and marketing expense Years ended December 31, Change 2025 vs. 2024 % of Revenue (dollar amounts in thousands) 2025 2024 $ % 2025 2024 Sales and marketing expense $ 97,692 $ 103,069 $ (5,377 ) -5.2 % 28.0 % 30.7 % Sales and marketing expense decreased $5.4 million, or 5.2%, for the year ended December 31, 2025 from the year ended December 31, 2024.
Other income, net Years ended December 31, Change 2024 vs. 2023 % of Revenue (dollar amounts in thousands) 2024 2023 $ % 2024 2023 Interest income, net $ 5,190 $ 6,574 $ (1,384 ) -21.1 % 1.5 % 2.1 % Other income, net 850 468 382 81.6 % 0.3 % 0.1 % Total other income, net $ 6,040 $ 7,042 $ (1,002 ) -14.2 % 1.8 % 2.2 % Total other income, net decreased $1.0 million for the year ended December 31, 2024 from the year ended December 31, 2023, a decrease of 14.2%.
Other income, net Years ended December 31, Change 2025 vs. 2024 % of Revenue (dollar amounts in thousands) 2025 2024 $ % 2025 2024 Interest income, net $ 4,385 $ 5,190 $ (805 ) -15.5 % 1.3 % 1.5 % Other income, net 2,443 850 1,593 187.4 % 0.7 % 0.3 % Total other income, net $ 6,828 $ 6,040 $ 788 13.0 % 2.0 % 1.8 % Total other income, net increased $0.8 million, or 13.0%, for the year ended December 31, 2025 from the year ended December 31, 2024 primarily due to net foreign currency gains.
We continue to evolve our operating model to focus the enhanced sales teams to drive increased rental revenue by establishing relationships with the prescriber through a consistent cadence of contact.
We continue to evolve our operating model to drive increased rental revenue by establishing relationships with prescribers through a targeted and consistent cadence of contact. • Invest in our respiratory product offerings to develop innovative products and expand clinical evidence .
This was primarily due to decreases of $8.5 million in consulting fees, $1.9 million in dues, fees and licenses, and $1.6 million in credit card and financing fees, partially offset by an increase of $5.1 million in media and advertising costs, $1.5 million in personnel-related expenses, and $0.9 million in travel costs.
This decrease was primarily due to decreases of $3.0 million in media and advertising costs, $1.2 million in consulting fees, $0.8 million in credit card and financing fees, and $0.7 million in dues, fees and licenses. In the year ended December 31, 2025, we spent $29.1 million in media and advertising costs versus $32.2 million in 2024.
The U.S. market represents a main opportunity for growth as we believe that the POC adoption is still in a low penetration rate. • Increase international business-to-business adoption. We continue to believe there is a sizable international market opportunity, particularly in Europe where there is existing oxygen reimbursement for respiratory conditions.
We offer patient-preferred, low total cost of ownership products to help providers convert their businesses to a non-delivery POC business model, and to drive overall value through quality products. • Increase international business-to-business adoption. We continue to believe there is a sizable international market opportunity, particularly in Europe where there is existing oxygen reimbursement for respiratory conditions.
We will begin efforts to obtain reimbursement coverage in the first quarter of 2025 for the Simeox product in the U.S. 65 Results of operations Comparison of years ended December 31, 2024 and 2023 Revenue Years ended December 31, Change 2024 vs. 2023 % of Revenue (dollar amounts in thousands) 2024 2023 $ % 2024 2023 Sales revenue $ 278,756 $ 251,607 $ 27,149 10.8 % 83.0 % 79.7 % Rental revenue 56,949 64,053 (7,104 ) -11.1 % 17.0 % 20.3 % Total revenue $ 335,705 $ 315,660 $ 20,045 6.4 % 100.0 % 100.0 % Sales revenue increased $27.1 million for the year ended December 31, 2024 from the year ended December 31, 2023, an increase of 10.8% from the prior year.
Results of operations Comparison of years ended December 31, 2025 and 2024 Revenue Years ended December 31, Change 2025 vs. 2024 % of Revenue (dollar amounts in thousands) 2025 2024 $ % 2025 2024 Sales revenue $ 295,304 $ 278,756 $ 16,548 5.9 % 84.7 % 83.0 % Rental revenue 53,364 56,949 (3,585 ) -6.3 % 15.3 % 17.0 % Total revenue $ 348,668 $ 335,705 $ 12,963 3.9 % 100.0 % 100.0 % Sales revenue increased $16.5 million, or 5.9%, for the year ended December 31, 2025 from the year ended December 31, 2024.
We intend to commercialize Simeox through the purchase of the product initially, followed by recurring sales of device disposables.
We intend to leverage our infrastructure and capabilities to commercialize Simeox through the sale or rental of the product initially, followed by recurring sales of device disposables. Through the Collaboration Agreement with Yuwell that we entered in January 2025, we have broadened our product portfolio.
The net changes in operating assets and liabilities resulted in net cash provided of $14.3 million.
The net changes in operating assets and liabilities resulted in net cash used of $26.9 million, which included the payment of the earnout liability of $9.8 million and $2.4 million in legal and settlement expenses.
For the year ended December 31, 2022, net cash provided by financing activities consisted of $1.7 million from the proceeds received from stock options that were exercised and purchases under our employee stock purchase program, partially offset by the payment of employment taxes related to the vesting of restricted stock awards and restricted stock units of $1.4 million.
For the year ended December 31, 2025, we received $27.2 million from Yuwell and $1.0 million in proceeds related to our 2014 Employee Stock Purchase Plan, or ESPP, partially offset by the payment of the earnout liability of $13.0 million and $2.4 million in legal and settlement expenses.
These decreases were partially offset by increases of $6.9 million in personnel-related expenses and $1.1 million in dues, fees and licenses.
These decreases were partially offset by an increase of $1.8 million in legal settlement costs.
These products would include innovations that strengthen our offerings in COPD, as well as future innovations that differentiate beyond devices to allow patients and clinicians to better manage respiratory disease with advanced portable oxygen concentrators with digital health value added services, expansion of use to hypercapnia, shortness-of-breath, and to other related disease indications.
Our goal is to enable patients and clinicians to better manage respiratory disease through advanced portable oxygen concentrators and other respiratory devices integrated with digital health services.
We sell multiple configurations of our Inogen One ® , Rove and Inogen At Home systems with various batteries, accessories, warranties, power cords, and language settings. Our goal is to design, build, and market oxygen solutions that redefine how long-term oxygen therapy is delivered. To accomplish this goal, we intend to: • Expand our domestic HME provider and reseller network.
We sell multiple configurations of our Inogen One ® , Rove, and At Home, and Voxi ® 5 oxygen concentrator systems, as well as our Simeox airway clearance system and Aurora CPAP masks, with various accessories, warranties, power cords, and language settings.
Simeox has been cleared under CE mark in the EU and is currently being sold in Europe and several other markets. In addition, we obtained 510(k) clearance for Simeox in December 2024 and plan to leverage our commercial infrastructure and capabilities to market the device in the United States, while continuing to market it in the other geographies.
Simeox has been cleared under CE mark in the European Union and through a 510(k) in the U.S. Simeox is being sold in Europe and several other markets. In 2025, we initiated efforts to obtain market feedback, as well as to initialize the work towards reimbursement coverage for Simeox in the U.S.
Cost of rental revenue increased $2.0 million for the year ended December 31, 2024 from the year ended December 31, 2023, an increase of 6.5%. The increase in cost of rental revenue was primarily attributable to an increase in service costs.
Rental revenue decreased $3.6 million, or 6.3%, for the year ended December 31, 2025 from the year ended December 31, 2024.
We remain focused on our domestic business-to-business partnerships, including relationships with distributors, key accounts, resellers, our private label collaborator, and traditional HME providers. We offer patient-preferred, low total cost of ownership products to help providers convert their businesses to a non-delivery POC business model.
Our goal is to design, build, and market respiratory therapy solutions that redefine how home respiratory care is delivered. To accomplish this goal, we intend to: • Expand our domestic home medical equipment, or HME, network. We remain focused on our domestic business-to-business partnerships, including relationships with distributors, key accounts, resellers, our private label collaborator, and traditional HME providers.
Removed
As a result of the Tidal Assist ® Ventilator technology intangible asset disposal in 2022, a quantitative analysis was required to be performed as of December 31, 2022 and concluded that there was no impairment.
Added
In particular, international conflicts could create instability, have and may further result in sanctions, tariffs, and other measures that restrict international trade and may negatively affect our business operations and results.
Removed
We continue to evaluate our hospital pilot program, which targets hospitals and practitioners to access patients earlier in their care pathway. • Invest in our product offerings to develop innovative products and expand clinical evidence .
Added
We continue to monitor the tariffs announced by the U.S. government, as well as the potential for additional or modified tariffs, and the imposition of tariffs or export controls by other countries. We do not currently expect a material impact to our business from the tariffs in the forms in which they are currently proposed.
Removed
We launched the Inogen ® Rove 4 ™ , our latest portable oxygen concentrator, in the U.S. and EU markets in October 2024, as well as in the UK in December 2024.
Added
We are focused on continuing to build a clinically meaningful pipeline that brings clear value to patients, prescribers, and customers. This includes innovations that deepen our strength in COPD and broader respiratory care, as well as future solutions that move beyond traditional devices.
Removed
The Inogen Rove 4 weighs 2.9 pounds and produces 840 ml per minute of oxygen output with quiet operations at 39 dBA and long battery life at 3 hours for a single battery, 4 hours and 15 minutes on our new intermediate battery, and up to 5 hours and 45 minutes for a double battery, as well as improvements to provide ease-of-use and improvements to design in compliance with MDR standards.
Added
In particular, we have commenced distribution of the Inogen branded Voxi 5 stationary oxygen concentrators and Aurora CPAP masks in the U.S. The Aurora CPAP masks are high-performing masks designed for patients with OSA. A more extensive launch of these products is planned in 2026 as we focus on market development.
Removed
The Inogen Rove 4 is our first POC to launch with three battery options. The Inogen Rove 4 has an 8-year expected service life. The 8-year expected service life also extends to the Inogen One G5 ® and Inogen ® Rove 6 ™ portable oxygen concentrators. We launched the Inogen One G5 in 2019.
Added
We are also continuing that collaboration to enhance our innovation pipeline and is working to accelerate the entry of our brand into the Chinese market, where we continue to work through the registration process for our products.
Removed
The Inogen One G5 is similar to the product specifications of the Inogen Rove 6. We estimate that the Inogen Rove 6 and Inogen One G5 are each suitable for over 90% of ambulatory long-term oxygen therapy patients based on our analysis of the patients who have contacted us and their clinical needs.
Added
The decrease in rental revenue was primarily related to a higher mix of lower private-payor reimbursement rates and fewer patients on service. 62 Years ended (dollar amounts in thousands) December 31, Change 2025 vs. 2024 % of Revenue Revenue by geographic region 2025 2024 $ % 2025 2024 U.S. sales $ 156,476 $ 161,549 $ (5,073 ) -3.1 % 44.9 % 48.1 % International sales 138,828 117,207 21,621 18.4 % 39.8 % 34.9 % U.S. rentals 53,364 56,949 (3,585 ) -6.3 % 15.3 % 17.0 % Total revenue $ 348,668 $ 335,705 $ 12,963 3.9 % 100.0 % 100.0 % U.S. sales decreased 3.1% for the year ended December 31, 2025 compared to the year ended December 31, 2024, primarily due to channel mix versus the comparable period in 2024.
Removed
Inogen Connect, our connectivity platform is available on our Inogen Rove 4, Inogen One G4 ® , Inogen One G5, and Inogen Rove 6 products in the United States and Canada, is compatible with Apple and Android platforms and includes patient features such as purity status, battery life, product support functions, notification alerts, and remote software updates.
Added
U.S. rentals decreased 6.3% for the year ended December 31, 2025 compared to the year ended December 31, 2024, primarily related to a higher mix of lower private-payor reimbursement rates and fewer patients on service.
Removed
We are focused on expanding new products that drive benefits to patients, prescribers and our customers with a clinically relevant pipeline.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

9 edited+0 added−0 removed8 unchanged
Biggest changeWe began entering into foreign exchange forward contracts to protect our forecasted U.S. dollar-equivalent earnings from adverse changes in foreign currency exchange rates. These hedging contracts reduce, but will not entirely eliminate, the impact of adverse currency exchange rate movements on revenue, cash, receivables and payables.
Biggest changeThese hedging contracts reduce, but will not entirely eliminate, the impact of adverse currency exchange rate movements on revenue, cash, receivables and payables. We performed a sensitivity analysis assuming a hypothetical 10% adverse movement in foreign exchange rates to the hedging contracts and the underlying exposures described above.
The effect of a 10% adverse change in exchange rates on foreign denominated cash, receivables and payables as of December 31, 2024 would not have had a material effect on our financial position, results of operations or cash flows.
The effect of a 10% adverse change in exchange rates on foreign denominated cash, receivables and payables as of December 31, 2025 would not have had a material effect on our financial position, results of operations or cash flows.
If overall interest rates had increased or decreased by 1.00% (100 basis points), our interest income would not have been materially affected during the years ended December 31, 2024 or December 31, 2023. ITEM 8.
If overall interest rates had increased or decreased by 1.00% (100 basis points), our interest income would not have been materially affected during the years ended December 31, 2025 or December 31, 2024. ITEM 8.
FINANCIAL STATEMENTS AN D SUPPLEMENTARY DATA The financial statements and supplementary data required by this item are included in Part IV, Item 15 of this Report. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None. 74
FINANCIAL STATEMENTS AN D SUPPLEMENTARY DATA The financial statements and supplementary data required by this item are included in Part IV, Item 15 of this Report. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None. 70
A hypothetical 1.00% (100 basis points) increase in interest rates would not have materially impacted the fair value of our marketable securities as of December 31, 2024 and December 31, 2023.
A hypothetical 1.00% (100 basis points) increase in interest rates would not have materially impacted the fair value of our marketable securities as of December 31, 2025 and December 31, 2024.
Changes in the intrinsic value are recorded as a component of accumulated other comprehensive loss and subsequently reclassified into revenue to offset the hedged exposures as they occur. Interest rate fluctuation risk We had cash and cash equivalents of $113.8 million as of December 31, 2024, which consisted of highly liquid investments with a maturity of three months or less.
Changes in the intrinsic value are recorded as a component of accumulated other comprehensive loss and subsequently reclassified into revenue to offset the hedged exposures as they occur. Interest rate fluctuation risk We had cash and cash equivalents of $103.7 million as of December 31, 2025, which consisted of highly liquid investments with a maturity of three months or less.
We estimate prior to any hedging activity that a 10% adverse change in exchange rates on our foreign denominated sales would have resulted in a $9.0 million decline in revenue for the year ended December 31, 2024. We designate these forward contracts as cash flow hedges for accounting purposes.
We estimate prior to any hedging activity that a 10% adverse change in exchange rates on our foreign denominated sales would have resulted in a $11.1 million decline in revenue for the year ended December 31, 2025. We designate these forward contracts as cash flow hedges for accounting purposes.
As our operations in countries outside of the United States grow, our results of operations and cash flows will be subject to fluctuations due to changes in foreign currency exchange rates, which could harm our business in the future.
As our operations in countries outside of the United States grow, our results of operations and cash flows will be subject to fluctuations due to changes in foreign currency exchange rates, which could harm our business in the future. 69 We began entering into foreign exchange forward contracts to protect our forecasted U.S. dollar-equivalent earnings from adverse changes in foreign currency exchange rates.
We performed a sensitivity analysis assuming a hypothetical 10% adverse movement in foreign exchange rates to the hedging contracts and the underlying exposures described above. As of December 31, 2024, the analysis indicated that these hypothetical market movements would not have a material effect on our financial position, results of operations or cash flows.
As of December 31, 2025, the analysis indicated that these hypothetical market movements would have a material effect on our financial position, results of operations or cash flows.

Other INGN 10-K year-over-year comparisons