What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2024-03-01 compared with 2023-02-24 · 178 added, 257 removed, 395 unchanged (52% of the section changed)

Inogen is a medical technology company whose purpose is improving lives through respiratory care.

We are a global leader in portable oxygen therapy solutions for patients with chronic respiratory conditions.

Our leading portfolio of innovative POCs are optimized to deliver high output ratio-to-weight, meaningful sound suppression and among the longest run times in the industry so that we can meet the needs of patients across a variety of disease states.

As of December 31, 2022, we had twenty-four pending patent applications and seventy-two issued patents relating to the design and construction of our respiratory devices.

We are positioned in the market as both a medical technology company and as a home medical equipment provider that is accredited in all 50 states in the United States with a significant patient, prescriber and provider reach.

Our products have been sold in 59 countries around the world through distributors and equipment companies outside of the United States and through direct patient and prescriber sales, as well as resellers and home medical equipment companies in the United States.

We employed 1,026 people as of December 31, 2022 and had total revenue of $377.2 million for the period ended December 31, 2022.

is a medical technology business that primarily focuses on respiratory health.

develops, manufactures, and markets innovative portable oxygen concentrators (POCs) used to deliver supplemental long-term oxygen therapy to patients suffering from chronic respiratory conditions.

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, 7 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.

While often used concomitantly with stationary oxygen concentrators and oxygen compressed gas tanks, our Inogen One systems 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.

Corporate history

10 unchanged sentences

is the remaining legal entity.

We completed the acquisition of New Aera, Inc (New Aera) on August 9, 2019.

We completed the acquisition of New Aera, Inc.

(New Aera) on August 9, 2019.

On September 14, 2023, we completed the acquisition of all of the issued and outstanding capital stock of Physio-Assist SAS (Physio-Assist) and its wholly-owned subsidiary PhysioAssist GmbH.

Chronic obstructive pulmonary disease

We are focused on oxygen therapy and 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.

We believe that our portable oxygen therapy solutions can help patients with chronic respiratory conditions, including patients with chronic obstructive pulmonary disease, (COPD).

COPD is a group of lung diseases including chronic bronchitis and emphysema.

4 unchanged sentences

According to the Forum of International Respiratory Societies, an estimated 200 million people in the world have COPD.

In the United States, a 2022 publication stated that COPD is the sixth leading cause of death.

The Centers for Disease Control (CDC) and Prevention in the United States estimates that prevalence of COPD amongst adults 18 years or older was around 5.2% to 6.2% based on CDC data of age-adjusted prevalence of COPD from 2011 to 2020.

In terms of economic impact, the total economic cost from COPD in the United States was approximately $50 billion in 2020 with close to 1.6 million COPD emergency department visits in 2019.

A peer-reviewed publication in the New England Journal of Medicine has stated that long-term oxygen therapy has been shown help COPD patients who have severely low blood oxygen or hypoxemia.

The Centers for Disease Control (CDC) and Prevention in the United States estimates that prevalence of COPD among adults 18 years or older was approximately 6.1% based on CDC data of age-adjusted prevalence of COPD from 2011 to 2021.

COPD is a major cause of disability and the sixth leading cause of death according to the CDC.

In terms of economic impact, the total economic cost from COPD in the United States was approximately $49 billion in 2020 with close to 925,000 COPD emergency department visits in 2020.

A peer-reviewed article in the New England Journal of Medicine has stated that long-term oxygen therapy has been shown help COPD patients who have severely low blood oxygen or hypoxemia.

Hypoxemic patients are unable to convert oxygen found in the air into the bloodstream in an efficient manner.

3 unchanged sentences

Oxygen therapy

Inogen created its first portable oxygen concentrators with a goal of creating a product that allows patients the chance to remain ambulatory while managing the impact of their disease.

Traditionally, oxygen patients have relied on stationary oxygen concentrator systems for use in the home and oxygen tanks or cylinders for mobile use, which we refer to as the delivery model.

The tanks and cylinders must be delivered regularly and have a finite amount of oxygen, which requires patients to plan activities outside of their homes around delivery schedules and a finite

oxygen supply.

The tanks and cylinders must be delivered regularly and have a finite amount of oxygen, which requires patients to plan activities outside of their homes around delivery schedules and a finite oxygen supply.

Additionally, patients must attach long, cumbersome tubing to their stationary concentrators simply to enable mobility within their homes.

Inogen created its first portable oxygen concentrators with a goal of creating a product that allows patients the chance to remain ambulatory while managing the impact of their disease.

Between 2012 and 2021, portable oxygen concentrators represented the fastest-growing segment of the Medicare oxygen therapy market.

However, based on 2021 traditional fee-for-service Medicare data, we estimate the portable oxygen concentrators still only represents approximately 22% of the total long-term oxygen therapy market in the United States.

The traditional fee-for-service Medicare data does not include data from private insurance, Medicare Advantage, Medicaid and cash-pay patients in the market.

We believe the following have hindered the market acceptance of portable oxygen concentrators:

to obtain portable oxygen concentrators, patients are dependent on home medical equipment providers, which have made significant investments in the physical distribution infrastructure to support the delivery model and which we believe are therefore disincentivized to encourage adoption of portable oxygen concentrators;

• to obtain portable oxygen concentrators, patients are dependent on home medical equipment providers, which have made significant investments in the physical distribution infrastructure to support the distribution and delivery of stationary devices and therefore may be disincentivized to encourage adoption of portable oxygen concentrators;

• 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;

1 unchanged sentence

• constrained manufacturing costs of conventional portable oxygen concentrators, driven by home medical equipment provider preference for products that have lower upfront equipment cost.

We believe that Inogen has an opportunity to grow and further develop the market for portable oxygen concentrator utilization, particularly for patients with chronic respiratory conditions.

Our transformation

Over the last year we have been strategically focused on evolving Inogen from a home medical equipment provider with product development capabilities, to a medical device company in respiratory care with home medical equipment operations in the United States.

As such, we have the capability to service patients and prescribers directly, as well as other home medical equipment providers and distributors.

As a part of this strategic focus we have been transforming the commercial organization to grow our business with a higher level of productivity and efficiency in our direct-to-consumer efforts.

We have also made organizational changes to focus on a prescriber sales team.

We believe this is complementary to our direct-to-consumer channel and provides the opportunity to work directly with prescribers and obtain prescriber referrals at the point of a patient’s diagnosis and prescription.

In addition, we have piloted projects with the intent to drive efficiency and productivity for our commercial organization in the United States.

These projects include streamlining and digitizing back-office processes in order to remove redundancies, improve process, and also scale back-office activities through digitization.

We believe we have the opportunity to grow and further develop the market for portable oxygen concentrator utilization, particularly for patients with chronic respiratory conditions.

Bronchiectasis

We expanded our addressable market opportunity into the bronchiectasis market with the acquisition of Physio-Assist in September 2023.

Physio-Assist developed and manufactures Simeox, a technology-enabled airway clearance device with a proven efficacy and safety profile, currently approved for use outside of the United States, to treat a condition in the lungs known as bronchiectasis, where the lung’s bronchi become damaged and widened, that is often present in cystic fibrosis and chronic obstructive pulmonary disease.

Simeox is used in pulmonary rehabilitation centers, as well as at home.

Simeox imminently expands our product offering in Europe, the Middle East and Africa (EMEA), and potentially in the U.S.

to serve COPD and other chronic disease patients who suffer from bronchiectasis with an innovative, non-invasive, and next generation airway clearance solution.

We believe that Inogen has an opportunity to potentially access a large growing bronchiectasis market opportunity in the U.S.

upon regulatory clearance.

Business strategy

We believe there is an opportunity to grow portable oxygen therapy usage and develop the market further to help patients with chronic conditions breathe better and help providers improve patient outcomes.

Our strategy for expanding our business and growing the market consists of the following four key elements:

Our strategy for expanding our business and growing the market includes:

Grow our core business.

We believe we have an opportunity to drive penetration of POC-based oxygen therapy versus other oxygen therapy modalities.

Enhance our business.

We are committed to the ongoing innovation of our products to meet the needs of patients and providers to manage lower blood oxygen and shortness-of-breath associated with COPD and other disease indications.

Accelerate our business .

We believe that we can develop the market and expand growth opportunities by generating clinical evidence.

Our clinical approach involves engaging with Key Opinion Leaders (KOLs) through our Scientific Advisory Board.

Enhance our business through innovation.

We are committed to the ongoing innovation to meet the needs of patients, providers, and our business-to-business partners to manage lower blood oxygen and shortness-of-breath associated with COPD and other disease indications.

Support adoption of Inogen products through clinical evidence and Key Opinion Leaders (KOLs) advocacy .

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 KOLs through our Scientific Advisory Board.

The KOLs goals are focused on advocating for the right therapy for patients and changing the behavior of prescribers.

Accelerate growth through strategic transactions.

We selectively evaluate potential strategic transactions to grow our portfolio or capabilities to serve the respiratory care market.

Our Inogen One portable oxygen systems provide patients who require long-term oxygen therapy with a reliable, lightweight single solution product that we believe allows patients the chance to remain ambulatory while managing the impact of their disease and eliminates dependence on both oxygen tanks and cylinders as well as stationary concentrators.

Our Inogen One and Inogen Rove portable oxygen systems provide patients who require long-term oxygen therapy with a reliable, lightweight single solution product that we believe allows patients the chance to remain ambulatory while managing the impact of their disease and eliminates dependence on both oxygen tanks and cylinders as well as stationary concentrators.

We have created a market leading portfolio of portable oxygen concentrators.

POC product features

We market our current portable product offerings, the Inogen One G5 and the Inogen One G4, as single solutions for long-term oxygen therapy.

This means our solutions can operate on a 24/7 basis for at least 60 months without a stationary concentrator, with minimal servicing of sieve beds, filters, and accessories.

The technology in our Inogen One systems is effective for nocturnal use.

Our Inogen One portable oxygen concentrators can operate reliably and cost-effectively over the long period of time needed to service long-term oxygen therapy patients without supplemental use of a stationary concentrator or a replacement portable oxygen concentrator.

We launched a new product in Europe in December 2022, Rove 6.

Rove 6 offers more flexibility for patients with six oxygen flow settings.

The following table summarizes our key product features:

Key Product Specifications

Inogen One G5

Inogen One G4

Capacity (ml/min)

4.8 (single battery)

4.7 (single battery)

2.8 (single battery)

5.8 (double battery)

5.7 (double battery)

3.3 (double battery)

Battery run-time

Up to 6.25 hours

Up to 6.5 hours

Up to 2.6 hours

(single battery)

Up to 12.75 hours

Up to 13 hours

Up to 5 hours

(double battery)

Technology effective for overnight use

We market our current portable product offerings, the Inogen Rove 6 system and the Inogen One G4 system as ambulatory solutions for long-term oxygen therapy.

Our solutions can operate up to 96 months when used for up to 8 hours per day for the Inogen One G5, Rove 4 and Rove 6 and up to 60 months for the Inogen One G4, with servicing of sieve beds, filters, and accessories that can be performed by patients themselves.

The technology in our Inogen One and Inogen Rove systems are effective for nocturnal use.

All of our portable oxygen systems are equipped with Intelligent Delivery Technology, a form of pulse-dose technology from which the patient receives a bolus of oxygen upon inhalation.

3 unchanged sentences

Our systems actively respond to this changing physiology through the use of proprietary technology that increases bolus size.

Our Intelligent Delivery Technology is designed to provide effective levels of blood oxygen saturation during sleep and all other periods of rest and activity that are substantially equivalent to continuous flow systems.

Our Intelligent Delivery Technology is designed to provide effective levels of blood oxygen saturation during sleep and all other periods of rest and activity.

We have also launched Inogen Connect, a wireless connectivity platform for the Inogen One G4, Inogen One G5 and 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.

1 unchanged sentence

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.

In Europe, we released our latest portable oxygen concentrator, Rove 6, in December 2022.

Inogen One G5 portable oxygen concentrator was released to market in April 2019 and is among the lightest products on the market and has among the highest oxygen production capabilities of the other sub-5 pound portable oxygen concentrators on the market.

We released our latest portable oxygen concentrator, Rove 6, in Europe in December 2022, and in the U.S.

in July 2023.

The Rove 6 was subsequently launched in the United States in August 2023.

The Inogen One G5 portable oxygen concentrator was released to market in April 2019 and is among the lightest products on the market and has among the highest oxygen production capabilities of the other sub-5 pound portable oxygen concentrators on the market.

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.

Stationary oxygen concentrator

We market our own 5-liter stationary oxygen concentrator, the Inogen At Home, capable of delivering continuous flow of oxygen for the patients who require it.

The Inogen At Home is one of the smaller, quieter and lower weight devices in this category.

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 payer requirements.

Airway clearance

We added Simeox, an airway clearance device, to our portfolio through the acquisition of Physio-Assist in September 2023.

Simeox is commercialized in the European Union and several other countries and 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.

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 was demonstrated in 10 clinical trials.

It is marketed in Europe under MDD regulations.

Domestic sales and marketing

4 unchanged sentences

To pursue a direct-to-consumer rental strategy, our manufacturing competitors would need to meet national accreditation and state-by-state licensing requirements and secure Medicare billing privileges as well as compete with the home medical equipment providers who many of our manufacturing competitors sell to across their entire homecare business.

Our direct-to-consumer sales and marketing efforts are focused on generating awareness and demand for our Inogen One systems 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 One, Inogen Rove and Inogen At Home systems among patients, physicians and other clinicians, and third-party payors.

Our direct-to-consumer rental selling efforts are focused on selling to prescribers in order to serve patients earlier at the point of diagnosis and prescription while capturing a higher proportion of the life-time value of prescribed oxygen therapy.

6 unchanged sentences

After a patient contacts us, we guide them through product selection and insurance eligibility, and, if they choose to move forward, process the necessary reimbursement and physician paperwork on their behalf as well as coordinate the shipping, instruction, and clinical setup process.

In accordance with Medicare regulations, we do not initially contact patients directly and contact them only upon an inbound inquiry or upon receipt of a physician’s order.

We have been targeting private payors to become an in-network provider of oxygen therapy solutions, which we expect will reduce patient co-insurance amounts associated with using our solution.

9 unchanged sentences

We also sell our products direct-to-consumers on a primarily prepayment basis.

Medicare’s service reimbursement programs represented more than 10% of our total revenue for the years ended December 31, 2022 and 2021.

One single customer represented more than 10% of our total revenue for the year ended December 31, 2020.

Two customers each represented more than 10% of our net accounts receivable balance with accounts receivable balances of $22.6 million and $9.9 million, respectively, as of December 31, 2022.

One single customer and Medicare each represented more than 10% of our net accounts receivable balance with accounts receivable balances of $5.9 million and $2.7 million, respectively, as of December 31, 2021.

We rent products directly to consumers for insurance reimbursement, which resulted in a customer concentration relating to Medicare’s service reimbursement programs.

Medicare’s service reimbursement programs accounted for 77.0%, 81.9% and 81.5% of

rental revenue in 2022, 2021 and 2020, respectively, and based on total revenue were 11.6%, 10.6% and 7.5% for 2022, 2021 and 2020, respectively.

Accounts receivable balances relating to Medicare’s service reimbursement programs (including held and unbilled receivables, net of allowances) amounted to $2.1 million or 3.4% of total net accounts receivable as of December 31, 2022 compared to $2.7 million or 11.0% of total accounts receivable as of December 31, 2021.

Medicare’s service reimbursement programs represented more than 10% of our total revenue for the years ended December 31, 2023, 2022 and 2021.

Two customers each represented more than 10% of our net accounts receivable balance with net accounts receivable balances of $8.6 million and $5.0 million as of December 31, 2023 and $22.6 million and $9.9 million as of December 31, 2022.

We rent products directly to consumers for insurance reimbursement, which resulted in a customer concentration relating to Medicare’s service reimbursement programs.

Medicare’s service reimbursement programs accounted for 67.7%, 77.0% and 81.9% of rental revenue in 2023, 2022 and 2021, respectively, and based on total revenue were 13.7%, 11.6% and 10.6% for 2023, 2022 and 2021, respectively.

Accounts receivable balances relating to Medicare’s service reimbursement programs (including held and unbilled receivables, net of allowances) amounted to $2.1 million or 4.9% of total net accounts receivable as of December 31, 2023 compared to $2.1 million or 3.4% of total accounts receivable as of December 31, 2022.

International

1 unchanged sentence

We sell through distributors, resellers, and home medical equipment providers in certain markets within Canada, Europe, the Asia-Pacific region, Latin America, the Middle East, and Africa.

To date, we have sold our products in a total of 59 countries outside the United States through distributors or directly to large “house”

accounts, which include gas companies and home oxygen providers.

To date, we have sold our products in a total of 62 countries outside the United States through distributors or directly to large “house” accounts, which include gas companies and home oxygen providers.

In this case, we sell to and bill the distributor or house accounts directly, leaving the patient billing, support, and clinical setup to the local provider.

1 unchanged sentence

No single international customer and no single foreign country represented more than 10% of our total revenue in 2023, 2022 or 2021.

Our fully-owned subsidiary, Inogen Europe B.V.

Our wholly-owned subsidiary, Inogen Europe B.V.

operates a European customer support site in the Netherlands.

This site offers multi-lingual customer service and sales support to improve our European customer support at lower cost.

Also in support of our European operations, we produce our Inogen One G3 and Inogen One G5 concentrators and perform related repair activities using a contract manufacturer, Foxconn, located in the Czech Republic to improve our ability to service our European customers.

Also, in support of our European operations, we produce our Inogen One G5 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 their Simeox product throughout Europe, the Middle East, Canada, and Australia.

Customer support

16 unchanged sentences

As a result, patients can rent or purchase our systems at the same patient obligation as other in-network oxygen suppliers.

We had 100 contracts as of December 31, 2022.

Private payors typically provide reimbursement at a rate similar to Medicare allowables for in-network plans.

3 unchanged sentences

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, 2022, approximately 77.0% of our rental revenue was derived from Medicare’s traditional fee-for-service reimbursement programs.

For the year ended December 31, 2023, approximately 67.7% of our rental revenue was derived from Medicare’s traditional fee-for-service reimbursement programs.

Medicare revenue, including patient co-insurance and deductible obligations, represented 13.7% of our total revenue in the year ended December 31, 2023 and 11.6% in the year ended December 31, 2022.

For additional discussion of the impact of the recent Medicare reimbursement proposals, see “Risk Factors”

For additional discussion of the impact of the recent Medicare reimbursement proposals, see “Risk Factors” herein.

Manufacturing and raw materials

We assemble the compressors, sieve beds, concentrators and certain manifolds in-house in order to improve quality control and reduce cost.

In support of our European sales, we use a contract manufacturer located in the Czech Republic to manufacture high volume products and perform product repairs to improve delivery to our European accounts.

We typically enter into master service agreements for these components that specify quantity and quality requirements and delivery terms.

We assemble the compressors, sieve beds, and concentrators in-house in order to improve quality control and reduce cost.

In support of our European sales, we use a contract manufacturer located in the Czech Republic to manufacture low to medium volume products and perform product repairs to improve delivery to our European accounts.

We typically enter into master service agreements with our major vendors for these components that specify supply requirements, quality and delivery terms.

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 facilities in Texas and California.

We expect to maintain our assembly operations for our products at our facility in Texas.

In 2023, we were focused on securing supply for components to make our products which included higher costs of semiconductor chips, reducing the cost of our Inogen One G5 product (excluding semiconductor chips), and increasing the robustness of our supply chain to reduce potential component constraints as we grow our business.

2 unchanged sentences

We have elected to source certain key components from single sources of supply, including our batteries, motors, valves, stationary concentrators, columns, and some molded plastic components.

In some cases, maintaining a single source of supply can allow us to control production costs and inventory levels and to manage component quality, but also may lead to supply availability risks and means our ability to maintain production is dependent on these single source suppliers, which may put us at an increased risk of supply disruption, as we have seen from the production halt we implemented in early January 2022 through early February 2022.

In order to help mitigate against the risks related to a single source of supply, for certain components we qualify alternative suppliers and develop contingency plans for responding to disruptions.

However, a continued reduction or halt in supply from one of these single-source suppliers, any dual-sourced suppliers or any other limited-source suppliers with similar sub-component suppliers could limit or prevent our ability to manufacture our products or devices until one or more sufficient replacement suppliers is found and qualified.

For additional discussion of potential risks related to our manufacturing and raw materials, please see the risk factor entitled “

We obtain some of the components, subassemblies and completed products included in our products from a single source or a limited group of manufacturers or suppliers, and in some cases those components are available in only limited supplies from limited manufacturers or suppliers, and the partial or complete loss of one or more of these manufacturers or suppliers could cause significant production delays or stoppages, an inability to meet customer demand, substantial loss in revenue, and an adverse effect on our financial condition and results of operations.

We currently manufacture in two leased buildings in Plano, Texas and Goleta, California, that we have registered with the Food and Drug Administration (FDA) and maintain a Quality Management system for which we have obtained International Standards Organization (ISO) 13485 certification.

For additional discussion of potential risks related to our manufacturing and raw materials, please see the risk factor entitled “ We obtain some of the components, subassemblies and completed products included in our products from a single source or a limited group of manufacturers or suppliers, and in some cases those components are available in only limited supplies from limited manufacturers or suppliers, and the partial or complete loss of one or more of these manufacturers or suppliers could cause significant production delays or stoppages, an inability to meet customer demand, substantial loss in revenue, and an adverse effect on our financial condition and results of operations.

We currently manufacture 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 (FDA) and maintain a Quality Management system for which we have obtained International Standards Organization (ISO) 13485 certification.

Our entire organization is responsible for quality management.

3 unchanged sentences

Our Quality Management system has been certified to ISO 13485:2016 by BSI, a Notified Body.

In 2020 and 2021, our contract manufacturer produced the vast majority of the Inogen One G3 concentrators required to support our European demand.

Our contract manufacturer also began manufacturing the Inogen One G5 in January 2020 and produced the vast majority of the Inogen One G5 concentrators required to support our European demand in 2021 and 2022, which we expect to continue in 2023.

Lastly, our contract manufacturer began repair services for the Inogen One product line in 2020 and repaired the majority of the Inogen One concentrators for our European customers.

This has allowed us to continue to expand our manufacturing and repair capacity and redirect our U.S.

manufacturing activities to focus on growth in the U.S.

and on our largest volume products, the Inogen One G5 and the Inogen One G4.

As of December 31, 2023, we had 206 employees in operations, manufacturing, quality assurance, manufacturing engineering and repair in the United States.

2 unchanged sentences

We use a combination of research and development staff along with third party resources to develop our products.

As of December 31, 2022, our research and development staff included 28 engineers and scientists with expertise in air separation, compressors, pneumatics, electronics, embedded software, mechanical design, sensor, automation, connectivity, non-invasive ventilation and manufacturing automation.

As of December 31, 2023, our research and development staff included 25 engineers and scientists with expertise in air separation, compressors, pneumatics, electronics, embedded software, mechanical design, sensor, automation, connectivity, digital health, and manufacturing automation.

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 production costs of our existing products, as well as developing our next-generation oxygen concentrators.

We have leveraged our seventy-two issued patents while also have historically reduced our overall POC system cost and intend to continue to seek ways to reduce our cost of revenue through manufacturing and design improvements.

We have released seven products since 2004, including our Inogen One G1 in October 2004, our Inogen One G2 in March 2010, our Inogen One G3 in September 2012, our Inogen At Home system in October 2014, our Inogen One G4 in May 2016, and our Inogen One G5 in April 2019.

In December 2022, we launched the Rove 6 in Europe, a new product that is not yet launched in the United States.

We also launched the Inogen Connect platform in December 2018 in our direct-to-consumer channel and in February 2019 in our domestic business-to-business channel.

Our pipeline and future innovation are informed by our Scientific Advisory Board and engagement with KOLs.

We have leveraged our eighty-seven issued patents while also have historically reduced our overall POC system cost and intend to continue to seek ways to reduce our cost of revenue through manufacturing and design improvements.

Following the acquisition of Physio-Assist, the engineering team is also leveraging the legacy Physio-Assist team to advance the development of the Simeox product line.

We continue to focus our efforts on design and functionality improvements that enhance patient quality of life and reduce service costs.

3 unchanged sentences

Our significant manufacturing competitors are Respironics (a subsidiary of Koninklijke Philips N.V.) Caire Medical (subsidiary of NGK Spark Plug), DeVilbiss Healthcare (a subsidiary of Drive Medical), O2 Concepts, Precision Medical, Gas Control Equipment (subsidiary of Colfax), Nidek Medical, 3B Medical, SysMed, and Belluscura.

Respironics announced in early 2024 that it would be leaving the U.S.

portable oxygen concentrator market until further regulatory assessments but continues to have product in the market.

This is not an exhaustive list of competitors.

13 unchanged sentences

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-marketing surveillance.

FDA’s pre-market clearance and approval requirements

Unless an exemption applies, each medical device we seek to commercially distribute in the United States will require either a prior Section 510(k) of the Food, Drug and Cosmetic Act, or 510(k) clearance, a De Novo authorization, or a pre-market approval from the FDA.

Medical devices are classified 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.

Devices deemed to pose lower risks are placed in either Class I or II, which requires the manufacturer to submit to the FDA a premarket notification requesting permission to commercially distribute the device.

3 unchanged sentences

510(k) clearance pathway

When a 510(k) clearance is required, we must submit a premarket notification to the FDA demonstrating that our proposed device is substantially equivalent to a “predicate device”

which can be a previously cleared and legally marketed 510(k) device or a device that was in commercial distribution before May 28, 1976 for which the FDA has not yet called for the submission of a pre-market approval application.

The performance goal for FDA to make a decision is within 90 FDA Days (calculated as the number of calendar days between the date the 510(k) was “accepted”

by the FDA for substantive review and date of a decision, excluding the days the submission was on hold for an Additional Information request).

When a 510(k) clearance is required, we must submit a premarket notification to the FDA demonstrating that our proposed device is substantially equivalent to a “predicate device” which can be a previously cleared and legally marketed 510(k) device or a device that was in commercial distribution before May 28, 1976 for which the FDA has not yet called for the submission of a pre-market approval application.

The performance goal for the FDA to make a decision is within 90 FDA Days (calculated as the number of calendar days between the date the 510(k) was “accepted” by the FDA for substantive review and date of a decision, excluding the days the submission was on hold for an Additional Information request).

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 FDA must “accept” the submission for substantive review and may require further information, including clinical data, to make a determination regarding substantial equivalence.

If the FDA determines that the device, or its intended use, is not substantially equivalent to a previously cleared device or use, the FDA will either allow the submission of a De Novo application, or place the device, or the particular use, into Class III.

2 unchanged sentences

We obtained 510(k) clearance for the Inogen At Home system on June 20, 2014.

We obtained 510(k) clearance for the Rove 4 system on December 9, 2022.

We obtained 510(k) clearance for the Rove 4 system on December 9, 2022 and 510(k) clearance for the Rove 6 system on June 30, 2023.

De Novo authorization pathway

(NSE) determination in response to a 510(k) notification or because there is no available predicate to which to claim substantial equivalence.

These types of applications are referred to as “Evaluation of Automatic Class III Designation”

or “De Novo.”

FDA review of a De Novo application may lead the FDA to authorize marketing of the device and classify it as either a Class I or II device, the latter of which can serve as a predicate device for other 510(k) premarket notification submissions.

The De Novo authorization pathway is a request to the FDA to classify novel devices of low to moderate risk that had automatically been placed in Class III either by virtue of receiving a “not substantially equivalent” (NSE) determination in response to a 510(k) notification or because there is no available predicate to which to claim substantial equivalence.

These types of applications are referred to as “Evaluation of Automatic Class III Designation” or “De Novo.” FDA review of a De Novo application may lead the FDA to authorize marketing of the device and classify it as either a Class I or II device, the latter of which can serve as a predicate device for other 510(k) premarket notification submissions.

Pre-market approval pathway

1 unchanged sentence

The pre-market approval application process is much more demanding than the 510(k) premarket notification process.

A pre-market approval application must be supported by extensive data, including but not limited to technical, preclinical, clinical trials, manufacturing and labeling to demonstrate to the FDA’s satisfaction reasonable evidence of safety and effectiveness of the device.

After a pre-market approval application is submitted and the FDA determines that the application is sufficiently complete to permit a substantive review, the FDA will accept the application for review.

The FDA has 180 days to review an “accepted”

pre-market approval application, although the review of an application generally occurs over a significantly longer period of time and can take up to several years.

The FDA has 180 days to review an “accepted” pre-market approval application, although the review of an application generally occurs over a significantly longer period of time and can take up to several years.

During this review period, the FDA may request additional information or clarification of the information already provided.

9 unchanged sentences

Even if a trial is completed, the results of clinical testing may not demonstrate the safety and efficacy of the device, may be equivocal or may otherwise not be sufficient to obtain approval or clearance of the product.

We have sponsored clinical studies and real-world data analyses that recently resulted in several publications in the areas of the following:

use of portable oxygen concentrators, 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 continue to invest in clinical research activities to support new product development, as well as expansion of the uses of its products and services.

Pervasive and ongoing regulation by the FDA and foreign agencies

3 unchanged sentences

• quality system regulation, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;

labeling regulations and the FDA prohibitions against the promotion of products for un-cleared, unapproved or “off-label”

uses, and other requirements related to promotional activities;

• labeling regulations and the FDA prohibitions against the promotion of products 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;

2 unchanged sentences

After a device receives 510(k) clearance, de novo clearance or a pre-market approval, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, will require a new clearance or approval.

The FDA requires each manufacturer to make this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination.

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.

29 unchanged sentences

Non-compliance with the Federal Anti-Kickback Statute can result in cancellation of our provider numbers and exclusion from Medicare, Medicaid or other federal healthcare programs, restrictions on our ability to operate in certain jurisdictions, as well as civil and criminal penalties, any of which could have an adverse effect on our business and results of operations.

Federal law also includes the Physician Self-Referral Law, commonly known as the “Stark Law,”

which prohibits a physician from referring a patient to an entity with which the physician (or an immediate family member of the physician) has a financial relationship, for the furnishing of certain designated health services for which payment may be made by Medicare or Medicaid, unless an exception applies.

Federal law also includes the Physician Self-Referral Law, commonly known as the “Stark Law,” which prohibits a physician from referring a patient to an entity with which the physician (or an immediate family member of the physician) has a financial relationship, for the furnishing of certain designated health services for which payment may be made by Medicare or Medicaid, unless an exception applies.

Violation of the Stark Law could result in denial of payment, disgorgement of reimbursements received under a non-compliant arrangement, civil penalties and fees, and exclusion from Medicare, Medicaid or other federal healthcare programs.

4 unchanged sentences

The Federal False Claims Act (as amended) provides that the federal government, and under certain circumstances a private party or whistleblower, may bring claims against a person who knowingly presents or causes to be presented a false or fraudulent request for payment to the federal government or uses a false statement or false record to get a claim approved.

Violations of the False

Claims Act can result in penalties up to $0.02 million for each claim, plus three times the amount of damages that the federal government sustained.

Violations of the False Claims Act can result in penalties up to $0.024 million for each claim, plus three times the amount of damages that the federal government sustained.

The Company is not aware of any pending claims against it under the False Claims Act.

11 unchanged sentences

The Company is not aware of any pending claims against it under such state laws.

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 healthcare providers, health plans and healthcare clearinghouses, which are referred to as “covered entities.”

Three standards 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, and 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.

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.

ARRA includes the Health Information Technology for Economic and Clinical Health, or HITECH, which, among other things, made HIPAA’s privacy and security standards directly applicable to business associates of covered entities effective February 17, 2010.

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.

A business associate is a person or entity that performs certain functions or activities on behalf of a covered entity that involve the use or disclosure of protected health information in connection with recognized healthcare operations activities.

12 unchanged sentences

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act enacted in 2018, extends the reporting and transparency requirements under the Physician Payments Sunshine Act to physician assistants, nurse practitioners and other mid-level practitioners, with reporting requirements going into effect in 2022 for payments made in 2021.

Failure to submit required ownership and investment interest information may result in civil monetary penalties of up to an aggregate of $0.18 million per year (or up to an aggregate of $1.191 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests that are not timely, accurately and completely reported in an annual submission.

Failure to submit required ownership and investment interest information may result in civil monetary penalties of up to an aggregate of $0.2 million per year (or up to an aggregate of $1.363 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests that are not timely, accurately and completely reported in an annual submission.

Certain states also mandate implementation of compliance programs, impose restrictions on device manufacturer marketing practices and/or require the tracking and reporting of gifts, compensation and other remuneration to physicians and other healthcare professionals.

The Patient Protection and Affordable Care Act also requires healthcare providers to voluntarily report and return an identified Medicare or Medicaid overpayment within 60 days after identifying the overpayment.

Failure to repay the overpayment within 60 days will result in the claim being considered a “false claim”

and the healthcare provider will be subject to False Claims Act liability, and additional CMPs of $0.022 million for each item or service that is not reported and returned.

Failure to repay the overpayment within 60 days will result in the claim being considered a “false claim” and the healthcare provider will be subject to False Claims Act liability, and additional CMPs of $0.024 million for each item or service that is not reported and returned.

International regulation

4 unchanged sentences

The method of assessing conformity 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 appointed by a country to conduct the conformity assessment.

This third-party assessment may consist of an audit of the manufacturer’s quality system, review of technical documentation, and specific testing of the manufacturer’s device.

Such an assessment may be required in order for a manufacturer to commercially distribute the product throughout these countries.

19 unchanged sentences

We also require our employees, consultants and advisors with whom we expect to work on our current or future products to agree to disclose and assign to us all inventions conceived during the workday, developed using our property or related to our business.

Despite any measures taken to protect our intellectual property, unauthorized parties may attempt to copy aspects of our Inogen One, Inogen At Home, or non-invasive ventilation systems, sell counterfeit versions of our products, or obtain and use information that we regard as proprietary.

As of December 31, 2022, we had twenty-four pending patent applications and seventy-two issued patents relating to the design and construction of our respiratory devices.

Despite any measures taken to protect our intellectual property, unauthorized parties may attempt to copy aspects of our Inogen One or Inogen At Home systems, sell counterfeit versions of our products, or obtain and use information that we regard as proprietary.

As of December 31, 2023, we had thirty-three pending patent applications and eighty-seven issued patents relating to the design and construction of our respiratory devices.

We anticipate it could take several years for the most recent of these patent applications to result in issued patents, if successful.

The 2019 acquisition of New Aera added a significant number of issued and pending patent applications to Inogen’s portfolio.

The 2023 acquisition of Physio-Assist added a significant number of issued and pending patent applications to Inogen’s portfolio.

The additional patents and patent filings include U.S.

and international pending and issued patents.

The combined portfolio of Inogen and New Aera include several categories.

The combined portfolio of Inogen and Physio-Assist include several categories.

Our patent portfolio contains four principal categories of patents and patent applications.

One such category includes patents and patent applications directed to system and component designs that may be incorporated into Inogen’s oxygen therapy product line which includes the Inogen One G3, Inogen One G4, Inogen One G5, and the Inogen At Home oxygen concentrators.

For example, U.S.

13 unchanged sentences

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).

This category of patents expired in 2023 or later (without taking into account any patent term adjustments).

Patents and patent applications in this category and others may facilitate the design and development of future respiratory products that can serve patients in need of supplemental oxygen and or mechanical ventilation therapies.

“Inogen,”

“Inogen One,”

“Inogen One G3,”

“G4,”

“G5,”

“Live Life in Moments, not Minutes,”

“Never Run Out of Oxygen,”

“Oxygen Therapy on Your Terms,”

“Oxygen.Anytime.Anywhere,”

“Reclaim Your Independence,”

“Intelligent Delivery Technology,”

“Inogen At Home,”

the Inogen design, “TIDAL ASSIST,”

“TAV,”

and “SIDEKICK”

our registered trademarks with the United States Patent and Trademark Office.

We own pending trademark applications for the marks “INOGEN ROVE 4”

and “INOGEN ROVE 6”

in the United States.

We own trademark registrations for the mark “Inogen”

in Argentina, Australia, Canada, Chile, China, Columbia, Ecuador, South Korea, Malaysia, Mexico, Europe (European Union Registration), the United Kingdom, Iceland, India, Israel, Japan, Kuwait, New Zealand, Norway, Paraguay, Peru, Turkey, Singapore, South Africa, Switzerland, and Uruguay.

We own a trademark registration for the mark “イノジェン”

We own trademark registrations for the marks “印诺真”

and “艾诺根”

We own trademark registrations for the mark “Inogen One”

in Australia, Canada, China, South Korea, Mexico, Europe (European Union Registration), and the United Kingdom.

We own a trademark registration for the mark “Satellite Conserver”

We own a trademark registration for the mark “Inogen At Home”

in Europe (European Union Registration) and the United Kingdom.

We own trademark registrations for the mark “G4”

in Europe (European Union Registration) and the United Kingdom.

We own trademark registrations for the mark “G5”

in Europe (European Union Registration) and the United Kingdom.

“Inogen,” “Inogen One,” “Inogen One G3,” “G4,” “G5,” “Oxygen.Anytime.Anywhere,” “Intelligent Delivery Technology,” “Inogen At Home,” the Inogen design, “TIDAL ASSIST,” “TAV,” and “SIDEKICK” are registered trademarks with the United States Patent and Trademark Office of Inogen, Inc.

We own pending applications for the marks “Rove,” “Inogen Rove,” “Inogen Rove 4” and “Inogen Rove 6” with the United States Patent and Trademark Office.

We own trademark registrations for the mark “Inogen” in Argentina, Australia, Canada, Chile, China, Columbia, Ecuador, South Korea, Malaysia, Mexico, Europe (European Union Registration), the United Kingdom, Iceland, India, Israel, Japan, Kuwait, New Zealand, Norway, Paraguay, Peru, Turkey, Singapore, South Africa, Switzerland, and Uruguay.

We own a pending application for the mark “Inogen” in the Dominican Republic.

We own a trademark registration for the mark “ イノジェン ” in Japan.

We own trademark registrations for the marks “ 印诺真 ” and “ 艾诺根 ” in China.

We own trademark registrations for the mark “Inogen One” in Australia, Canada, China, South Korea, Mexico, Europe (European Union Registration), and the United Kingdom.

We own a trademark registration for the mark “Satellite Conserver” in Canada.

We own a trademark registration for the mark “Inogen At Home” in Europe (European Union Registration) and the United Kingdom.

We own trademark registrations for the mark “G4” in Europe (European Union Registration) and the United Kingdom.

We own trademark registrations for the marks “Inogen Rove 4” and “Inogen Rove 6” in Europe (European Union Registrations) and the United Kingdom.

We own trademark registrations for the mark “G5” in Europe (European Union Registration) and the United Kingdom.

We own pending applications for the marks “Inogen Rove 4,” and “Inogen Rove 6,” “Rove 4” in Canada, .

We own pending applications for the mark “Rove 6” in Canada, Europe (the European Union), and the United Kingdom.

We own a trademark application for the Inogen design in Bolivia.

We own a trademark registration for the Inogen design in China.

We own a trademark registration for the mark “إنوجن”

in Saudi Arabia.

We own a trademark registration for the mark “إنوجن” in Saudi Arabia.

We own a pending application for the Inogen One G5 design in Brazil.

Other service marks, trademarks, and trade names referred to in this Annual Report on Form 10-K are the property of their respective owners.

“PHYSIO-ASSIST,” “PHYSIOASSIST,” the Physio-Assist logo, “SIMEOX,” “SIMEOX PRO,” “SIMESOFT,” “PHYSIOWEB,” “PHYSIODATA,” “PHYSIOSERVICES,” and the Pissenlit logo are registered trademarks of Inogen’s wholly-owned subsidiary Physio-Assist.

Physio-Assist owns trademark registrations for the mark “PHYSIO-ASSIST” in European Union, France, Japan, United Kingdom, and USA.

Physio-Assist owns trademark registrations for the Physio-Assist logo in China, European Union, France, Japan, South Korea, United Kingdom, and USA.

Physio-Assist owns trademark registrations for the mark SIMEOX in European Union, France, Japan, Russia, United Kingdom, and USA.

Physio-Assist owns trademark registrations in France for the mark “PHYSIOASSIST,” “SIMESOFT,” “SIMEOX PRO,” “PHYSIOWEB,” “PHYSIODATA,” “PHYSIOSERVICES,” and the Pissenlit logo.

Human capital

5 unchanged sentences

As of December 31, 2023, we had 834 full and part-time employees worldwide, consisting of 387 employees in sales, marketing, clinical and client services, 206 employees in operations, manufacturing, quality assurance, manufacturing engineering, and repair, 207 employees in general administration and 34 employees in research and development.

In addition, we had 59 temporary workers as of December 31, 2022, primarily in operations, to support spikes in demand.

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's right, (2) Invest in people, and (3) Treat people right.

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.

This is activated through our five cultural pillars which are (1) Create Trust, (2) Inspire Initiative, (3) Achieve Together, (4) Invite Diversity, and (5) Make a Difference.

Onboarding, leadership development and regular engagement surveys create a sustainable ecosystem for these values and culture pillars to thrive.

Additionally, all of our directors, officers, and employees are guided by our Code of Ethics and Conduct, which is published on the Investor Relations section of Inogen's website at:

1 unchanged sentence

The Code of Ethics and Conduct summarizes the compliance and ethical standards we expect of our employees and directors, the procedures for a suspected breach, and the consequences of any substantiated breach.

The Code of Ethics and Conduct also constitutes Inogen’s Code of Ethics and Conduct under US law and the NASDAQ exchange’s listing standards.

The Code of Ethics and Conduct also constitutes Inogen’s Code of Ethics and Conduct under U.S.

law and the NASDAQ exchange’s listing standards.

It deals with conflicts of interest, confidential information, fair dealing with customers, suppliers, competitors, and healthcare professionals, and compliance with financial reporting, insider trading, and other financial market regulation.

Talent acquisition and development

We encourage Inogen employees to take advantage of learning opportunities and we provide financial support through a tuition reimbursement program to help employees complete their college education and be prepared for higher level positions.

We are actively working toward a formal career planning program and building out both associate and leader learning curriculums.

As noted above we seek strong talent with subject matter expertise and provide competitive wages.

We also promote from within and encourage Inogen employees to take advantage of learning opportunities and we provide financial support through a tuition reimbursement program to help employees complete their college education and be prepared for higher level positions.

We have a strong leadership and manager program and standardized cultural onboarding for all associates.

Diversity, equity, inclusion, belonging and accessibility (DEIBA)

Diversity, equity, inclusion, belonging and accessibility are essential elements of Inogen’s business practices.

We are committed to creating and maintaining a workplace in which all employees have an opportunity to participate and contribute to the success of the business and are valued for their skills, experience, and unique perspectives.

The collective sum of the individual differences, life experiences, knowledge, inventiveness, innovation, self-expression, unique capabilities and talent that employees invest in their work represents a significant part of our culture as well as our reputation and achievements.

We embrace employees’

diversity of background, experience, culture, and other characteristics that make employees unique.

We embrace employees’ diversity of background, experience, culture, and other characteristics that make employees unique.

All employees are expected to exhibit conduct that reflects inclusion during work, at work functions on or off the work site, and at all other company-sponsored and participative events.

1 unchanged sentence

Internal communications and celebration are further proof points for our efforts as we routinely measure employee engagement in these categories.

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 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.

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.

1 unchanged sentence

Consistent with the Americans with Disabilities Act and similar state and local laws, we work with qualified employees and applicants with disabilities in order to identify and provide reasonable accommodations that can enable them to perform their jobs.

Inogen’s equal employment opportunity philosophy applies to all aspects of employment with Inogen including recruiting, hiring, job assignment, training, promotion, job benefits, compensation, discipline, and dismissal.

Inogen has implemented policies, procedures, and trainings to ensure that any reports of potential discrimination or harassment are appropriately investigated and corrected.

Health and safety

Our approach to health and safety uses both our management systems 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.

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.

7 unchanged sentences

Climate Change

As a global respiratory therapy and medical device company, Inogen recognizes that greenhouse gas (GHG) emissions affect our climate and pose a serious challenge to the environment—and ultimately to the global economy.

We believe that everyone shares responsibility to improve energy efficiency and to reduce GHG emissions in the atmosphere.

10 unchanged sentences

Our long-term GHG reduction strategy is to optimize the processes that consume non-renewable resources within this network.

We also recognize that, as a critical component of our customers’

supply chains, Inogen plays an important role in helping them operate in a more environmentally sustainable way.

We also recognize that, as a critical component of our customers’ supply chains, Inogen plays an important role in helping them operate in a more environmentally sustainable way.

We run our operations on a just-in-time basis;

4 unchanged sentences

During the years ended December 31, 2023, 2022, and 2021, substantially all of our long-lived assets were located within the United States.

See Note 2 to our audited consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional information related to our U.S.

See Note 2 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional information related to our U.S.

We believe our sales may be impacted by seasonal factors.

For example, we typically experience higher total sales 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.

In particular, due to the COVID-19 pandemic and related PHE, we have seen and expect to continue to see a disruption in our normal seasonal trends due to the mandates and behaviors emanating from the COVID-19 pandemic and related PHE, including shelter-in-place orders, reduced travel, and lower consumer confidence, and we did not see the typical seasonal increases in direct-to-consumer sales in 2020 that we have seen in prior years, although a partial return to normal seasonal trends was seen in 2021 and 2022.

Additionally, as more home medical equipment (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.

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 more home medical equipment (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.

For the years ended December 31, 2022, 2021, and 2020, the sales revenue in the second quarter accounted for 27.9%, 29.0% and 23.4%, respectively, and the sales revenue in the third quarter accounted for 28.3%, 26.0% and 23.8%, respectively, of our total sales revenue.

Corporate and available information

We were incorporated in Delaware in November 2001.

Our principal executive offices are located at 301 Coromar Drive, Goleta, California 93117.

Our principal executive offices are located at 859 Ward Drive, Goleta, California 93111.

Our telephone number is (805) 562-0500.

13 unchanged sentences

The following table identifies certain information about our executive officers as of February 23, 2024.

Nabil Shabshab

Chief Executive Officer, President, and Director

Kristin Caltrider

Executive Vice President, Chief Financial Officer and Corporate Treasurer

Executive Vice President, Chief Commercial Officer

Stanislav Glezer

Executive Vice President, Chief Technology Officer

Executive Vice President, R&D and Chief Medical Officer

Executive Vice President, General Counsel and Corporate Secretary

Bart Sanford (1)

Executive Vice President, Operations

(1) As disclosed in the Current Report on Form 8-K we filed with the SEC on February 10, 2023, Mr.

Sanford will be separating from the Company on or before March 1, 2023.

Nabil Shabshab has served as our President, Chief Executive Officer, and as a director since February 2021.

Gregoire Ramade

Executive Vice President, Chief Commercial Officer

Smith has served as our President, Chief Executive Officer, and as a director since November 2023.

Previously, Mr.

Shabshab served as Worldwide President of Diabetes Care and Digital Health at Becton Dickinson and Company from August 2017 until January 2021 and served as its Chief Marketing Officer and Executive Vice President of Strategic Planning from August 2011 until May 2017.

Previously, from 2006 to 2010, Mr.

Shabshab served as EVP, Global Portfolio, Chief Marketing Officer and Head of RD&E of Diversey, Inc., a cleaning and sanitation solutions company.

Prior to that, from 2004 to 2006, Mr.

Shabshab served as Principal of The Zyman Group, a marketing consulting firm.

Smith served as the CEO, President and Executive Director at Sirtex Medical US Holdings, Inc., a biotechnology company, from 2019 to 2023, after serving as Executive Vice President of Sales & Marketing, Americas from 2017 to 2019.

From 2021 to 2022, Mr.

Shabshab served as Vice President, Client Solutions and Consulting, of Symphony IRI, a consumer marketing firm.

Prior to that, Mr.

Shabshab served in various sales and marketing roles in consumer goods companies.

Shabshab holds an MBA from Northwestern University Kellogg School of Management and a B.S.

in Computer Sciences from American Lebanese University.

The board of directors believes that Mr.

Shabshab’s extensive industry experience qualifies him to serve on our board of directors.

Kristin Caltrider has served as our Executive Vice President, Chief Financial Officer, and Corporate Treasurer since March 2022.

Caltrider previously served as the Vice President of Finance at Quidel Corporation, a manufacturer of medical diagnostic products, since June 2014.

Prior to her time as Vice President of Finance, Ms.

Caltrider held various other roles at Quidel Corporation from May 2007 to June 2014, including Vice President of Financial Planning and Analysis, Senior Director of Financial Planning and Analysis, and Director of Financial Planning and Analysis.

Prior to Quidel, Ms.

Caltrider served as a Director of Finance at Life Technologies Corporation, a biotechnology company, from September 2003 to May 2007.

Caltrider holds an MBA from the University of San Diego and a B.A.

in Business Administration from California Lutheran University.

George Parr has served as our Executive Vice President and Chief Commercial Officer since April 2021.

Most recently, Mr.

Parr served as Executive Vice President & Chief Marketing Officer at Becton Dickinson and Company, a leading medical technology company, from November 2017 through January 2020.

Previously, from 2014 to 2017, Mr.

Parr served as Senior Vice President & Chief Marketing Officer at SIRVA Worldwide Relocation & Moving, a moving industry company.

Prior to that, from 2006 to 2013, Mr.

Parr served at Diversey, Inc., a cleaning and hygiene solutions company, as Senior Vice President & Chief Marketing Officer from 2010 to 2013 and Worldwide General Manager, Kitchen Hygiene & Fabric Care from 2006 to 2010.

Prior to that, Mr.

Parr served in various managing roles in consumer goods companies.

Parr holds a MBA from DePaul University and a B.S.

in Accounting from LaSalle University.

Stanislav Glezer has served as our Executive Vice President, Chief Technology Officer since October 2021, responsible for R&D and Engineering, Medical Affairs, and Regulatory Affairs.

Glezer has also served as our Executive Vice President and Chief Medical Officer from June 2021 to October 2021.

Smith also served as interim President and Chief Executive Officer and Director at OncoSec Medical, Inc., a biotechnology company.

In his previous roles Mr.

Smith served as Executive Vice President of Business Development at Gel-e, Inc., as Chief Commercial Officer at Sensium Healthcare, as Global Vice President of Sales & Marketing at Teleflex, and served in various sales and marketing roles in medical device companies.

Smith holds a Master of Business Administration in Global Management from University of Phoenix and a Bachelor of Science in Marketing from the University of Kentucky.

Sergesketter has served as our Executive Vice President, Chief Financial Officer, and Corporate Treasurer since September 2023.

Previously, Mr.

Sergesketter served as our interim Executive Vice President, Chief Financial Officer from December 2021 to March 2022.

Sergesketter previously served as CFO of Kimball Electronics, Inc.

and brings over forty years of finance experience in the manufacturing services industry.

He also brings expertise working across business functions, including with the CEO and Board of Directors, Audit Committee and Compensation and Governance Committee.

As part of his role as the CFO of Kimball Electronics, Inc.

following its spin-off in 2014 and through June 2021, Mr.

Sergesketter led the transformation of the finance and reporting functions to support the newly formed public company, helping to formulate and execute on the strategy that led to global expansion.

During his tenure at Kimball Electronics and its predecessors, Mr.

Sergesketter had the responsibility for a number of critical finance functions, including SEC reporting, Treasury, Investor Relations, Tax, Financial Planning & Analysis, Internal Audit while playing a leading role in various M&A transactions in the U.S.

Stanislav Glezer has served as our Executive Vice President, R&D and Chief Medical Officer since January 2024, responsible for R&D and Engineering, Medical Affairs, Regulatory Affairs, and Quality.

Glezer also served as our Executive Vice President and Chief Technology Officer from October 2021 to January 2024 and as our Executive Vice President and Chief Medical Officer from June 2021 to October 2021.

Previously, Dr.

6 unchanged sentences

Glezer served in a number of roles of progressively increasing seniority, including, Global Project Head for the largest late-stage pipeline asset, Vice President of Evidence and Value & Access, Vice President of Medical Affairs, and Senior Director of Medical Strategy & Operations, for Sanofi S.A., a multinational pharmaceutical company, from 2001 to 2015.

Dr Glezer holds a doctor of medicine from Moscow State University of Medicine and Dentistry and a MBA from California Coast University.

Dr Glezer holds a doctor of medicine from Moscow State University of Medicine and Dentistry and an MBA from California Coast University.

Jason Somer has served as our Executive Vice President and General Counsel and Secretary since July 2021.

Most recently, Mr.

Previously, Mr.

Somer served as head Legal Counsel at Invoca, Inc., a SaaS analytics company.

11 unchanged sentences

from the University of Western Ontario in Biology/Pharmacology.

Bart Sanford has served as our Executive Vice President, Operations since September 2018.

From April 2017 to September 2018, Mr.

Sanford was Senior Vice President, Operations, at Cepheid Inc., a molecular diagnostics company.

From October 2010 to March 2017, Mr.

Sanford was Vice President, Global Operations, at Molecular Devices, LLC, a life sciences company.

From January 2009 to September 2010, Mr.

Sanford was a Corporate Director at Danaher Corporation, a medical device company.

From March 2000 to December 2008, Mr.

Sanford held various positions at Fluke Corporation, an industrial test product company, including plant manager, manufacturing manager and materials manager.

Sanford received an MBA from Central Michigan University and a Bachelor of Arts degree in Logistics, Materials and Supply Chain Management from Michigan State University.

Gregoire Ramade has served as our Chief Commercial Officer since January 2024 and served as our Senior Vice President of International Sales from November 2023 to January 2024.

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, Inc.

since May 2016.

Ramade worked at Becton Dickinson Medical-Pharmaceutical Systems as Vice President of Global Marketing and Business Development from January 2013 to May 2016.

He also held the positions of Senior Marketing Director Home Healthcare Solution at Philips Healthcare from 2010 to 2012, Marketing Director EMEA at Philips Respironics from 2005 to 2009 and Product Manager of Consumable Masks and Accessories at Philips Respironics from 2004 to 2005.

Ramade holds a bachelor’s degree in International Business with a minor in Economics from the American University of Paris and an MBA in International Business and Marketing from the Ecole Nationale des Ponts et Chausses School of International Management.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business