We were incorporated in Delaware on November 27, 2001.
−Removed: We are a medical technology company that primarily develops, manufactures and markets innovative portable oxygen concentrators used to deliver supplemental long-term oxygen therapy to patients suffering from chronic respiratory conditions.
−Removed: Long-term oxygen therapy is defined as the provision of oxygen therapy for use at home in patients who have chronic low blood oxygen levels (hypoxemia).
+Added: We are a medical technology company that primarily develops, manufactures and markets innovative portable oxygen concentrators (POCs) used to deliver supplemental long-term oxygen therapy to patients suffering from chronic respiratory conditions.
Traditionally, these patients have relied on stationary oxygen concentrator systems for use in the home and oxygen tanks or cylinders for mobile use, which we call the delivery model.
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Additionally, patients must attach long, cumbersome tubing to their stationary concentrators simply to enable mobility within their homes.
−Removed: Our proprietary Inogen One ® systems concentrate the air around the patient to offer a single source of supplemental oxygen anytime, anywhere with a portable device weighing as little as approximately 2.8 pounds with a single battery.
−Removed: Our Inogen One systems range from 2.6 to 6.5 hours of battery life with a single battery and can be plugged into an outlet when at home, in a car, or in a public place with outlets available.
+Added: Our proprietary Inogen One ® systems concentrate the air around the patient to offer a single source of supplemental oxygen anytime, anywhere with a single battery and can be plugged into an outlet when at home, in a car, or in a public place with outlets available.
We believe 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.
Portable oxygen concentrators represented the fastest-growing segment of the Medicare oxygen therapy market between 2012 and 2019.
−Removed: Based on 2018 traditional fee-for-service Medicare data, we estimate the number of patients using portable oxygen concentrators represents approximately 13.9% of the total long-term oxygen therapy market (and 18.2% of the total ambulatory long-term oxygen therapy market) in the United States, although the traditional fee-for-service Medicare data does not account for private insurance, Medicare Advantage, Medicaid and cash-pay patients in the market.
+Added: Based on 2019 traditional fee-for-service Medicare data, we estimate the number of patients using portable oxygen concentrators represents approximately 18% of the total long-term oxygen therapy market (and approximately 23% of the total ambulatory long-term oxygen therapy market) in the United States, although the traditional fee-for-service Medicare data does not account for private insurance, Medicare Advantage, Medicaid and cash-pay patients in the market.
We believe we were the first oxygen therapy manufacturer to employ a direct-to-consumer marketing strategy, meaning we advertise directly to patients, process their physician paperwork, and provide clinical support as needed.
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is the remaining legal entity.
−Removed: We acquired New Aera, Inc.
−Removed: (New Aera) on August 9, 2019.
+Added: We completed the acquisition of New Aera on August 9, 2019.
We estimate approximately 3 million patients in the United States used long-term oxygen therapy in 2019 based on 2019 traditional fee-for-service Medicare data, commercial payor data and our estimate of the size of additional patient populations, such as the retail sales and Veterans Administration (VA) population.
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COPD is the third leading cause of death in the United States and one of the leading causes of death globally.
−Removed: There are an estimated 251 million individuals worldwide who have COPD, with an estimated greater than 100 million individuals located in China.
+Added: There are an estimated 251 million individuals worldwide who have COPD, with an estimated 100 million individuals located in China.
Smoking is the leading cause of COPD.
−Removed: However, the European Respiratory Journal published a study in July 2019 that concluded ambient air
−Removed: pollution was associated with lower lung function and increased COPD prevalence , based on over 300,000 individuals aged 40 to 69 years.
+Added: However, the European Respiratory Journal published a study in July 2019 that concluded ambient air pollution was associated with lower lung function and increased COPD prevalence, based on over 300,000 individuals aged 40 to 69 years.
According to our analysis of 201 9 traditional fee-for-service Medicare data, approximately 7 8 % of U.S.
−Removed: long-term oxygen therapy users utilized ambulatory oxygen and the remaining 24% were considered stationary, and either required oxygen twenty-four hours a day, seven days a week, or 24/7, but were not ambulatory, or did not require oxygen 24/7 and only needed nocturnal oxygen.
+Added: long-term oxygen therapy users utilized ambulatory oxygen and the remaining 2 2 % were considered stationary, and either require d oxygen twenty-four hours a day, seven days a week, or 24/7, but were not ambulatory, or d id not require oxygen 24/7 and only need ed nocturnal oxygen.
Clinical data has shown that ambulatory patients who use oxygen therapy 24/7 , regardless of modality , have approximately two times the survival rate and spend at least 60% fewer days annually in the hospital than non-ambulatory 24/7 oxygen therapy patients.
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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;
−Removed: 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 Medicare reimbursement due to pending Round 2021 competitive bidding winners and reimbursement rates;
+Added: 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;
lack of patient and physician awareness of the existence and benefits of portable oxygen concentrators as an oxygen solution instead of the traditional delivery model;
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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.
−Removed: We have also launched Inogen Connect, a new wireless connectivity platform for the Inogen One G4 and Inogen One G5 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.
+Added: We have also launched Inogen Connect, a wireless connectivity platform for the Inogen One G4 and Inogen One G5 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.
The Inogen Connect app is compatible with Apple and Android platforms and includes patient features such as oxygen purity status, battery run time, product support functions, notification alerts, and remote software updates.
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At approximately 18 pounds, we believe the Inogen At Home concentrator is the lightest five liter per minute continuous flow oxygen concentrator on the market today.
−Removed: Additionally, the Inogen At Home product has low power consumption with worldwide electrical compatibility, which should reduce the cost of electricity for oxygen therapy patients, as well as reduce manufacturing and distribution complexities.
+Added: Additionally, the Inogen At Home product has low power consumption with worldwide electrical compatibility, which should reduce the cost of electricity for oxygen therapy patients and reduce environmental impact of the product, as well as reduce manufacturing and distribution complexities.
While the Inogen One product line is clinically validated for 24/7 use, the Inogen At Home product represents a compelling solution for stationary long-term oxygen therapy patients that do not require a portable solution, which are estimated to represent approximately 22.2% of total long-term oxygen therapy patients in the United States based on 2019 traditional fee-for-service Medicare data.
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In the United States, we market and distribute our products directly to consumers through a wide variety of direct-to-consumer sales and marketing strategies including consumer advertising, an inside sales staff, and a physician referral model.
+Added: We initially planned for sales and marketing expansion in 2020, but this expansion was negatively impacted due to the COVID-19 pandemic and related PHE, which we believe reduced the close rates on patients who contacted us in 2020, led to less efficient marketing spend, caused a reduction in the number of oxygen therapy patients who responded to our marketing campaigns, and had a negative impact on the timing of a pricing trial, all of which resulted in leading us to stall the planned sales and marketing expansion, and as a result of which we also hired fewer sales representatives than initially planned.
Of the $246.3 million of our 2020 revenue derived from the United States, approximately 49.4% represented direct-to-consumer sales, 39.1% represented sales to traditional home medical equipment providers, distributors (including our private label partner) and resellers, and 11.5% represented direct-to-consumer rentals.
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Patients who choose to use their Medicare or private insurance benefits typically rent our systems.
−Removed: Those who purchase our product outright are typically patients who are not eligible to use their insurance benefits due to their capped rental status, prefer our Inogen One G4 and Inogen One G5 products that are not currently available for rent, prefer to own the equipment, prefer new equipment, or have an immediate need for our product that cannot be processed in time by their primary insurance carrier (e.g., an upcoming trip).
+Added: Those who purchase our product outright are typically patients who are not eligible to use their insurance benefits due to their capped rental status , prefer our Inogen One G4 and Inogen One G5 product s that are not currently available for rent, prefer to own the equipment, prefer new equipment, or have an immediate need for our product that cannot be processed in time by their primary insurance carrier (e.g., an upcoming trip) .
Our ability to rent to Medicare patients directly, bill Medicare and other third-party payors on their behalf, and service patients in their homes requires that we hold a valid Medicare supplier number, are accredited by an independent agency approved by Medicare, and comply with the differing licensure and process requirements in the 50 states in which we serve patients.
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In addition to generating consumer demand, we believe our products can create value for our business partners by either creating a retail sale opportunity for them or by reducing the need for costly home deliveries associated with oxygen tanks.
−Removed: We also sell to resellers and traditional homecare providers in the United States, Canada, Europe, the Asia-Pacific region, Latin America, the Middle East and Africa that choose to deploy our products to long-term oxygen therapy patients.
+Added: We also sell to resellers and traditional homecare providers in the United States, Canada, Europe, the Asia-Pacific region, Latin America, the Middle East and Africa that choose to deploy our products to long-term oxygen therapy patients either through insurance reimbursement or retail.
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 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.
−Removed: We also sell to traditional homecare providers that offer our products to patients through insurance reimbursement or retail worldwide.
−Removed: Homecare providers that employ the standard delivery model with oxygen tanks need to replace the oxygen tanks on a regular basis by picking up the empty oxygen tanks and delivering full oxygen tanks for the patient.
−Removed: The delivery model has historically necessitated that a homecare provider have a facility near the oxygen patients that it serves and that the provider has invested in personnel, trucks, etc.
+Added: Traditional h omecare providers that employ the standard delivery model with oxygen tanks need to replace the oxygen tanks on a regular basis by picking up the empty oxygen tanks and delivering full oxygen tanks for the patient.
+Added: The delivery model has historically necessitated that a homecare provider has a facility near the oxygen patients that it serves and that the provider has invested in personnel, trucks, etc.
to facilitate routine deliveries.
The cost to deliver the oxygen tanks to patients is significant for many providers in the standard delivery model.
−Removed: Homecare providers that have adopted Inogen products should be able to reduce the costly deliveries associated with oxygen tanks since our products generate their own oxygen and don’t need to be refilled.
+Added: Homecare providers that have adopted Inogen products should be able to reduce the costly deliveries associated with oxygen tanks since our products generate their own oxygen and do n o t need to be refilled.
Our business-to-business sales and marketing strategy for these customers is to raise awareness of our solutions and educate homecare providers on how our products may be able to reduce their total cost of ownership of servicing oxygen patients.
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We also private label our product with a business partner that sells to traditional homecare providers.
−Removed: Our private label partner employs field sales representatives that call on homecare providers to showcase the benefits of our products.
+Added: Our private label partner employs field sales representatives who call on homecare providers to showcase the benefits of our products.
Concentration of Customers
−Removed: We primarily sell our products to traditional home medical equipment providers, distributors, and resellers in the United States and in foreign countries on a credit basis.
+Added: We primarily sell our products to traditional home medical equipment providers, distributors, and resellers in the United States and in foreign countries primarily on a credit basis.
We also sell our products direct-to-consumers on a primarily prepayment basis.
+Added: For the year ended December 31, 2020, one single customer represented more than 10% of our total revenue, OxyGo HQ Florida (previously named Applied Home Healthcare Equipment), our private label distribution partner.
For the year ended December 31, 2019, no single customer represented more than 10% of our total revenue.
−Removed: For the years ended December 31, 2018 and 2017, one single customer, OxyGo HQ Florida (previously named Applied Home Healthcare Equipment), our private label distribution partner, represented more than 10% of our total revenue.
+Added: For the year ended December 31, 2018, one single customer, OxyGo HQ Florida, represented more than 10% of our total revenue.
As of December 31, 2020 and December 31, 2019, two customers each represented more than 10% of our net accounts receivable balance with accounts receivable balances of $8.4 million and $7.0 million, respectively, and accounts receivable balances of $10.7 million and $5.2 million, respectively.
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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.
−Removed: As of December 31, 2019, we had 13 people located in the United States who focused on selling our products and providing service and support to distributors and house accounts worldwide and 11 employees located in Europe who provided sales, customer service, and repair services to a portion of our international customers.
+Added: As of December 31, 2020, we had 14 people located in the United States who focused on selling our products and providing service and support to distributors and house accounts worldwide and 9 in-house and contract employees and independent employees located in Europe who provided sales and customer support services to a portion of our international customers.
No single international customer and no single foreign country represented more than 10% of our total revenue in 2020, 2019 or 2018.
−Removed: International sales revenue was flat at $ 78.0 million in 201 9 versus $ 77.3 million in 201 8 .
−Removed: While growth was limited in 2019, w e believe that the international market is attractive for the following reasons:
+Added: We believe that the international oxygen therapy market is attractive for the following reasons:
more favorable reimbursement rates in certain countries, including France and the United Kingdom, where portable oxygen concentrators receive higher reimbursement rates than in the United States;
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In 2017, we added a European customer support site in the Netherlands after acquiring a previous distributor, MedSupport, now operating under Inogen Europe B.V.
−Removed: This site offers multi-lingual customer service, repair services, and basic distribution, to improve our European customer support at lower cost.
−Removed: Also in support of our European operations, we began production of our Inogen One G3 concentrator in the fourth quarter of 2017 using a contract manufacturer, Foxconn, located in the Czech Republic to improve our ability to service our European customers, and we began manufacturing the Inogen One G5 concentrators in this facility in the first quarter of 2020.
+Added: This site offers multi-lingual customer service and sales support to improve our European customer support at lower cost.
+Added: 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.
Order fulfillment and customer support
Our procedures are designed to enable us to package and ship a system directly to the patient in the patient’s preferred configuration and we aim to do so the same day the order is received in most cases.
−Removed: This enables us to minimize the amount of finished goods inventory we keep on hand.
−Removed: Our primary logistics partner is United Parcel Service (UPS).
−Removed: UPS supports our domestic shipments and provides additional services that support our direct-to-consumer oxygen therapy program.
−Removed: The UPS pick up service is used to retrieve products requiring repair and systems that are no longer needed by the patient.
−Removed: When necessary, we utilize a courier for white-glove service whereby the courier goes into a patient’s home to remove a replacement product from the box, package the failed device and return it to us.
+Added: This enables us to minimize the amount of
+Added: finished goods inventory we keep on hand.
+Added: Our primary logistics partner for shipments originating in the U.S.
+Added: is FedEx , which also provides additional services that support our direct-to-consumer oxygen therapy program.
+Added: The FedEx pick up service is used to retrieve products requiring repair and systems that are no longer needed by our rental patient s .
+Added: When necessary, we utilize a courier for white-glove service whereby the courier go es into a patient’s home to remove a replacement product from the box, package the failed device and return it to us.
In this manner, we are able to operate as a remote provider while maintaining the level of customer service of a local oxygen therapy provider.
−Removed: FedEx primarily supports our international shipments that originate from the United States and limited domestic shipments.
We believe it is important to provide patients with quality customer support to achieve satisfaction with our products and optimal outcomes.
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Our dedicated billing services team is available to answer patient questions regarding invoicing, reimbursement, and account status during normal business hours.
−Removed: We receive no additional reimbursement for patient support, but provide high-quality customer service to enhance patient comfort, satisfaction, compliance, and safety with our products.
+Added: We receive no additional reimbursement for patient support, but we provide high-quality customer service to enhance patient comfort, satisfaction, compliance, and safety with our products.
Third-party reimbursement
−Removed: Medicare and private insurance rentals represented approximately 5.9% of our total revenue in 2019, down slightly from 6.2% of our total revenue in 2018, primarily due to increased sales revenue and declines in patients on service.
+Added: Medicare and private insurance rentals represented 9.2% of our total revenue in 2020, up from 5.9% of our total revenue in 2019, primarily due to decreased sales revenue and increased rental patients on service.
In cases where we rent our long-term oxygen therapy solutions directly to patients, we bill third-party payors, such as Medicare or private insurance, for monthly rentals on behalf of our patients.
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For the year ended December 31, 2020, approximately 81.5% of our rental revenue was derived from Medicare’s traditional fee-for-service reimbursement programs.
−Removed: list price for our stationary oxygen rentals (HCPCS E1390)
−Removed: is $260 per month and the U.S.
+Added: list price for our stationary oxygen rentals Healthcare Common Procedure Coding System (HCPCS E1390) is $260 per month and the U.S.
list price for our oxygen generating portable equipment (OGPE) rentals (HCPCS E1392) is $70 per month.
−Removed: T he average Medicare reimbursement rates in competitive bidding areas in 2018 were $77.03 a month for E1390 and $36.06 a month for E1392.
−Removed: These are the two primary codes that we bill to Medicare and other payors for our oxygen product rentals.
−Removed: Effective January 1, 2019, Medicare beneficiaries may receive durable medical equipment from any Medicare-enrolled supplier until new contracts are in effect under competitive bidding Round 2021, which is expected to begin on January 1, 2021.
−Removed: Reimbursement rates between January 1, 2019 and December 31, 2020 are set at the current pricing level throughout the United States for all Medicare patients, subject to Consumer Price Index (CPI) and budget neutrality adjustments.
−Removed: Pricing in competitive bidding areas is subject to annual CPI adjustments beginning in 2019 until Round 2021 begins.
−Removed: However, Centers for Medicare and Medicaid Services (CMS) also changed the calculation on budget neutrality to apply the offset to all oxygen and oxygen equipment classes beginning January 1, 2019 instead of previously only applying these adjustments to stationary oxygen equipment and oxygen contents.
−Removed: Based on these CPI and budget neutrality adjustments, effective January 1, 2019 the average Medicare reimbursement rates in former competitive bidding areas decreased to $72.92 a month for E1390 and $35.72 a month for E1392.
−Removed: Medicare also established new payment classes for liquid oxygen equipment and high flow portable liquid oxygen contents effective January 1, 2019.
−Removed: Effective January 1, 2020, the average Medicare reimbursement rates were increased by 1.5% to $73.98 a month for E1390 and $36.25 a month for E1392 in these regions that were previously subject to competitive bidding.
−Removed: In addition, the average Medicare reimbursement rates in non-rural, non-former competitive bidding areas increased by 3.5% to $74.84 a month for E1390 and $36.87 a month for E1392.
−Removed: In Round 2021 of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) competitive bidding program, there have been some revisions to the bidding methodology including bid surety bond requirements, lead item pricing, and setting reimbursement rates at the maximum winning bid rate instead of the median winning bid rate.
−Removed: In the prior round of competitive bidding, our products were categorized in the product category of respiratory equipment and related supplies and accessories, which included oxygen equipment, continuous positive airway pressure (CPAP) devices and respiratory assist devices (RADs) and related supplies and accessories.
−Removed: In Round 2021 of the competitive bidding program, oxygen and oxygen equipment is its own product category and the lead item has been established as E1390.
−Removed: However, due to the lead item pricing methodology based on the 2015 standard Medicare fee schedule, E1392 reimbursement rates could be reduced significantly (we estimate approximately 42%) even if E1390 reimbursement rates do not change.
−Removed: This would lead to combined E1390 plus E1392 reimbursement rates to decrease by approximately 15%.
−Removed: The bidding window closed on September 18, 2019 and we bid in 129 of the 130 total Competitive Bidding Areas (CBAs).
−Removed: It is unclear how pricing will be impacted due to these new bids.
−Removed: We expect contracts and pricing to be announced in 2020.
+Added: The average Medicare reimbursement rates in former competitive bidding areas (CBAs) in the prior four years are outlined in the table below for E1390 and E1392, which are the two primary codes that we bill to Medicare and other payors for our oxygen product rentals.
+Added: These rates were updated annually each January as they are subject to Consumer Price Index (CPI) and budget neutrality adjustments.
+Added: Competitive bidding contracts were scheduled to go into effect on January 1, 2021, however, on October 27, 2020, CMS announced that competitive bidding contracts would not be awarded for most product categories, including oxygen, due to the payment amounts not achieving the expected savings and the current COVID-19 pandemic and related PHE.
+Added: See the table below for average Medicare rates in former CBAs, using a simple average of rates in each CBA.
+Added: Average Medicare reimbursement rates in former CBAs
+Added: As of January 1, 2021
+Added: As of January 1, 2020
+Added: As of January 1, 2019
+Added: As of January 1, 2018
In addition to regional pricing, CMS imposed different pricing on “frontier states” and rural areas.
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and non-contiguous United States areas include AK, HI, Guam and Puerto Rico.
−Removed: Effective June 1, 2018 through December 31, 2020, for frontier and rural states, frontier and rural zip codes in non-frontier/rural states and non-contiguous United States areas, the single payment amount will be 50/50 blended reimbursement rates based on an average of the pre-competitive bidding reimbursement rates and the current average reimbursement rates to account for higher servicing costs in these areas.
−Removed: In 2019, this rate was $134.71 a month for E1390 and $44.32 a month for E1392, and this rate increased by 1.5% effective January 1, 2020 to $136.71 a month for E1390 and $44.93 a month for E1392.
+Added: Effective June 1, 2018 through December 31, 2020, for frontier and rural states, frontier and rural zip codes in non-frontier/rural states and non-contiguous United States areas, the single payment amount was 50/50 blended reimbursement rates based on an average of the pre-competitive bidding reimbursement rates and the current average reimbursement rates to account for higher servicing costs in these areas.
+Added: The Medicare reimbursement rates in rural areas is outlined in the table below, and include areas that are considered non-contiguous (Alaska, Hawaii, Puerto Rico, and the Virgin Islands).
We estimate that approximately 15% of our patients are eligible to receive the higher reimbursement rates based on the geographic locations of our current patient population.
+Added: Note that the 2021 rates listed below include Coronavirus Aid, Relief, and Economic Security (CARES Act) increased rates due to the COVID-
+Added: 19 PHE, which may not be in place for all of 2021.
+Added: See the table below for average Medicare rates in rural areas, using a simple average of rates in each state.
+Added: Average Medicare reimbursement rates in rural areas
+Added: As of January 1, 2021
+Added: As of January 1, 2020
+Added: As of January 1, 2019
+Added: As of January 1, 2018
+Added: Rates in non-former CBAs that are not defined as rural are set based on the rates in former CBAs.
+Added: See the table below for average Medicare rates in these non-former CBAs, non-rural areas, using a simple average of rates in each state.
+Added: Note that the 2021 rates listed below include CARES Act increased rates due to the COVID-19 PHE, which may not be in place for all of 2021.
+Added: Average Medicare reimbursement rates in non-former CBAs, non-rural areas
+Added: As of January 1, 2021
+Added: As of January 1, 2020
+Added: As of January 1, 2019
+Added: As of January 1, 2018
+Added: There have been significant U.S.
+Added: reimbursement and policy changes that impact oxygen therapy associated with the COVID-19 PHE declared by the U.S.
+Added: Department of Health and Human Services (HHS) on January 31, 2020.
+Added: The CARES Act allows HHS to waive certain Medicare telehealth payment requirements during the COVID-19 PHE to allow beneficiaries in all areas to receive telehealth services, including at their home, starting March 6, 2020.
+Added: The Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R.
+Added: 6074) also granted HHS the authority to waive certain requirements with respect to telehealth services.
+Added: Under this authority, CMS clarified that HHS would not conduct audits to determine whether there was a prior physician-patient relationship for telehealth claims submitted during the COVID-19 PHE.
+Added: The CARES Act included the extension of the 50/50 blended rate for home medical equipment (HME) in rural and non-contiguous, non-competitively bid areas and established a new 75/25 blended rate for all other non-competitively bid areas through the duration of the COVID-19 PHE.
+Added: The 75/25 blended rate was retroactive to March 6, 2020.
+Added: While the duration of the current emergency is impossible to predict, the Zika virus PHE lasted approximately 360 days, and the H1N1 flu PHE lasted approximately 450 days.
+Added: The CARES Act also included a temporary elimination of the 2% percent Medicare sequestration reduction that went into effect in 2013.
+Added: The CARES Act implemented the relief effective May 1, 2020 through December 31, 2020.
+Added: The Consolidated Appropriations Act of 2021 was signed into law on December 27, 2020 and extended the suspension period to March 31, 2021.
+Added: The CARES Act also extended the end date of the Medicare sequestration reduction by one year, through 2030, in order to offset the 2020 suspension.
+Added: On April 6, 2020, an Interim Final Rule (IFR) was published in the Federal Register for policy and regulatory revisions in response to the COVID-19 PHE.
+Added: This IFR included that for the duration of the COVID-19 PHE, the face-to-face requirements and clinical indications of coverage for home oxygen, among other respiratory products, is waived.
+Added: In addition, the administration has issued a number of regulatory waivers to increase the flexibility in DMEPOS suppliers’ ability to service patients quickly and without the normal requirements.
+Added: For example, the patient’s signature for proof of delivery has been waived when signatures cannot be collected during the COVID-19 PHE.
+Added: In addition, CMS increased Medicare contractors’ ability to waive replacement product requirements, paused the national prior authorization program for certain DMEPOS, automatically extended expiring accreditations, granted contractors the flexibility to grant appeals extensions, and medical review suspension.
+Added: Both the IFR and temporary regulatory changes show significant flexibility from CMS to improve access for oxygen and other DMEPOS items during this COVID-19 PHE.
+Added: These changes were retroactive to early March 2020.
+Added: However, in July 2020, CMS released a COVID-19 Provider Burden Relief FAQs document that stated that CMS would resume full operations for the prior authorization program for certain DMEPOS effective August 3, 2020.
+Added: CMS also issued a proposed rule on November 4, 2020 (CMS-1738-P) to establish payment amounts going forward for DMEPOS products and services covered under Medicare.
+Added: We believe that Medicare rates will not change for the length of the COVID-19 PHE, except for any net change for inflation and budget neutrality adjustments, as outlined above.
+Added: CMS is proposing three different fee schedule adjustment methodologies for non-CBAs after the termination of the COVID-19 PHE:
+Added: (1) for non-contiguous non-CBAs;
+Added: (2) for contiguous non-CBAs defined as rural areas;
+Added: and (3) for non-rural non-CBAs within the contiguous United States.
+Added: Proposed adjustment methodologies (1) and (2) contemplate utilizing the 50/50 blended rates as a permanent construct, but proposed adjustment methodology (3) contemplates setting the fee schedule amounts to 100% of the Medicare rates.
+Added: This could reduce Medicare rates after the PHE is over in the current areas that are considered non-rural but not covered by a former CBA, as those areas are currently receiving a 75/25 blended reimbursement rate.
+Added: There was a 60-day comment
+Added: period on this proposed rule, and we expect this rule to be finalized in the first half of 2021.
+Added: In January 2021, CMS announced the pivotal bid amounts for the competitive bidding round 2021.
+Added: As a reminder, the bids for oxygen were based on the HCPCS code E1390, which is for stationary oxygen, and there were 130 regions bid.
+Added: The simple average of the 2018 single payment amounts for these regions for this code was $73.98 .
+Added: The simple average of the pivotal bid amounts for these regions for this code was $122.61, or an average increase of 65.7%.
+Added: If CMS would have implemented these rate changes, the simple average payment amounts in these regions for POCS (codes E1390 and E1392) would have been $157.60, which is significantly higher than the simple average payment amounts of $110.07 per month being paid as of January 1, 2021 for these regions .
+Added: CMS is required to propose future rounds of competitive bidding, which could change reimbursement rates, negatively impact the premium for POCs over other oxygen modalities, or limit beneficiary access to our technologies.
Cumulatively in previous rounds of competitive bidding, we were offered contracts for a substantial majority of the CBAs and product categories for which we submitted bids.
−Removed: As of January 1, 2017, we believe we had access to over 90% of the Medicare oxygen therapy market based on our analysis of the 103 CBAs that we won out of the 130 total CBAs.
−Removed: These 130 CBAs represented approximately 36% of the Medicare market with the remaining approximately 64% of the market not subject to competitive bidding per Medicare’s data on 2018 traditional Medicare fee-for-service beneficiaries in CBAs as compared to the total Medicare fee-for-service beneficiaries.
+Added: As of January 1, 2017 (when the last round of competitive bidding was in effect), we believe we had access to over 90% of the Medicare oxygen therapy market based on our analysis of the 103 CBAs that we won out of the 130 total CBAs.
+Added: These 130 CBAs represented approximately 36% of the Medicare market with the remaining approximately 64% of the market not subject to competitive bidding per Medicare’s data on 2018 traditional Medicare fee-for-service beneficiaries in CBAs compared to the total Medicare fee-for-service beneficiaries.
As of January 1, 2019, we can choose to accept Medicare oxygen patients throughout the United States.
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We did not sell or rent to patients in Hawaii due to the licensure requirements from inception to June 2018.
−Removed: We cannot guarantee that we will be offered contracts in subsequent rounds of competitive bidding.
+Added: We cannot guarantee that we will be offered contracts in any subsequent rounds of competitive bidding that are offered.
In all five rounds of competitive bidding in which we have participated, we have gained access to certain CBAs and been excluded from other CBAs.
−Removed: Medicare revenue, including patient co-insurance and deductible obligations, represented 4.8% of our total revenue in the year ended December 31, 2019.
+Added: Medicare revenue, including patient co-insurance and deductible obligations, represented 7.5% of our total revenue in the year ended December 31, 2020 and 4.8% in the year ended December 31, 2019.
Medicare reimbursement for oxygen rental equipment is limited to a maximum of 36 months within a 60-month service period, and the equipment remains the property of the home oxygen supplier.
−Removed: The supplier that billed Medicare for the 36th month of service continues to be responsible for the patient’s oxygen therapy needs for months 37 through 60, and there is generally no additional reimbursement for oxygen generating portable equipment for these later months.
+Added: The supplier that billed Medicare for the 36th month of service continues to be responsible for the patient’s oxygen therapy needs for months 37 through 60, and there is generally no additional reimbursement for OGPE for these later months.
Medicare does not separately reimburse suppliers for oxygen tubing, cannulas and supplies that may be required for the patient.
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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 for the years ended December 31, 2020 and December 31, 2019.
−Removed: Our capped patients as a percentage of total patients on service was approximately 20.
−Removed: 3 % as of December 3 1 , 201 9 , which was slightly higher than the capped patients as a percentage of total patients on service of approximately 19.1 % as of December 3 1 , 201 8 .
+Added: Our capped patients as a percentage of total patients on service was approximately 11.7% as of December 31, 2020 and 20.3% as of December 31, 2019.
The percentage of capped patients may fluctuate over time as new patients come on service, patients come off of service before and during the capped rental period, and existing patients enter the capped rental period.
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If the equipment malfunctions, we must repair or replace the equipment.
−Removed: We determine what equipment the patient receives, as long as that equipment meets the physician’s prescription, and we can deploy used assets in working order as long as the prescription requirements are met.
+Added: We determine what equipment the patient receives, and we can deploy used assets in working order as long as the prescription requirements are met.
We must also procure a recertification of the certificate of medical necessity from the patient’s doctor to confirm the patient’s need for continued oxygen therapy one year after the patient first receives oxygen therapy and one year after each new 36-month reimbursement period begins.
The patient can choose to receive oxygen supplies and services from another supplier at any time, but the supplier may only transition the patient to another supplier in certain circumstances.
−Removed: Round 2021 of the competitive bidding program includes non-invasive ventilation (NIV) as a new product category effective January 1, 2021 for HCPCS code E0466.
−Removed: Average Medicare reimbursement rates for HCPCS code E0466 were a monthly, non-capped rental with rates of $1,042.26 a month in 2019, and increased 0.9% effective January 1, 2020 to $1,051.64 a month, excluding Puerto Rico where the monthly Medicare reimbursement rate for E0466 was $1,827.24 per month in 2019 and increased to $1,843.69 a month effective January 1, 2020.
−Removed: Since this is the first-time non-invasive ventilators are being included in the competitive bidding program, it is uncertain what impact bidding will have on the reimbursement rates.
−Removed: If there is a significant decline in reimbursement rates or changes in coverage criteria, this may negatively impact the adoption of the Tidal Assist ® Ventilator (TAV ® ) product by home medical equipment providers, or increase pricing pressure, as well as negatively impact our rental reimbursement rates, which would adversely affect our business, financial condition and results of operations .
−Removed: It is also uncertain if we will win any bids for NIV for Round 2021 of the competitive bidding program.
−Removed: We have not previously provided NIV products to Medicare beneficiaries.
−Removed: If we do not win contracts to service Medicare beneficiaries for NIV in Round 2021, that may limit our ability to grow rental revenue for NIV.
−Removed: It is also uncertain if the current TAV product acquired from New Aera, will be reimbursable in its current configuration under HCPCS code E0466.
−Removed: We requested confirmation on the assigned HCPCS codes for the TAV system from the Pricing, Data Analysis, and Coding Contractor in August 2019 following the closing of the New Aera transaction.
+Added: Average Medicare reimbursement rates for NIV HCPCS code E0466 are listed in the table below and were a monthly, non-capped rental .
+Added: These rates exclude Puerto Rico, where rates have ranged from $1,786.16 to $1,847.38 over the periods presented.
+Added: Average Medicare reimbursement rates for NIV (excludes Puerto Rico)
+Added: As of January 1, 2021
+Added: As of January 1, 2020
+Added: As of January 1, 2019
+Added: As of January 1, 2018
+Added: It is uncertain if the current Tidal Assist ® Ventilator (TAV ® ) product acquired from New Aera, will be reimbursable in its current configuration under HCPCS code E0466.
+Added: We requested confirmation on the assigned HCPCS codes for the TAV system from the Pricing, Data Analysis, and Coding (PDAC) Contractor in August 2019 following the closing of the New Aera transaction.
In August 2019, we received positive confirmation that this product was assigned HCPCS code E0466.
However, in September 2019, we received a revised communication that the product was assigned HCPCS code E1390 and E1352, which was then revoked at our request in December 2019.
−Removed: In September 2019, we appealed to the Centers for Medicare and Medicaid Services, and in January 2020 our appeal was denied.
−Removed: We are currently pursuing additional appeal opportunities.
−Removed: If we do not receive revised coding, it could limit this product’s adoption by home medical equipment providers and also our direct rentals.
+Added: In September 2019, we appealed to CMS, and in January 2020 our appeal was denied.
+Added: In September 2020, we filed a lawsuit against Palmetto GBA, LLC and Alex Azar and Seema Verma in their official capacities at the Department of Health and Human Services and the Centers for Medicare and Medicaid Services, respectively.
+Added: The lawsuit seeks to invalidate the retraction of a valid HCPCS code to Inogen’s TAV system and claims a violation of our procedural rights provided under the Social Security Act, the Administrative Procedure Act, and our due process rights due to CMS’ failure to provide notice and the opportunity to comment on a change in HCPCS code verification for the TAV product.
+Added: If we do not receive revised coding, it could limit this product’s adoption by HME providers and also our direct rentals.
+Added: In addition, the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) had a meeting on July 22, 2020 to discuss home use of non-invasive positive pressure ventilation in patients with chronic respiratory failure consequent to chronic obstructive pulmonary disease (COPD).
+Added: CMS is seeking MEDCAC’s recommendations regarding the characteristics that define patient selection and usage criteria for these items.
+Added: This request could signal forthcoming changes in Medicare coverage of these items, and possibly changes in HCPCS codes, which could impact our NIV business and growth initiatives.
+Added: For a discussion of certain significant risks relating to the TAV reimbursement and the upcoming round of competitive bidding, see the risk factor entitled “ The competitive bidding process or other reimbursement policy changes under Medicare or other third-party payors could negatively affect our business and financial condition.”
As of December 31, 2020, we had 91 contracts with Medicaid, Medicare Advantage, government and private payors.
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Based on our patient population, we believe at least 42% of all oxygen therapy patients are covered by Medicare Advantage, government, and other private payors.
−Removed: Private payors typically provide reimbursement at a rate similar to Medicare allowables for in-network plans.
+Added: Private payors typically provide reimbursement at a rate similar to what Medicare allows for in-network plans.
We anticipate that private payor reimbursement levels will generally be reset in accordance with Medicare payment amounts.
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We have historically been able to reduce our costs through scalable manufacturing, better sourcing, continuous innovation, and reliability improvements, as well as innovations that reduce our product service costs by minimizing exchanges.
−Removed: As a result of design changes, supplier negotiations, bringing manufacturing and assembly largely in-house
−Removed: and our commitment to driving efficient manufacturing processes, we have reduced our overall POC system cost by approximately 5 9 % from 2009 to 201 9 .
+Added: As a result of design changes, supplier negotiations, bringing manufacturing and assembly largely in-house and our commitment to driving efficient manufacturing processes, we have reduced our overall POC system cost by approximately 59% from 2009 to 2020.
We intend to continue to seek ways to reduce our cost of revenue through manufacturing and design improvements.
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While nearly all of our manufacturing and assembly processes were originally outsourced, assembly of the compressors, sieve beds, concentrators and certain manifolds were brought in-house in order to improve quality control and reduce cost.
−Removed: In support of our European sales, we established a physical presence in Europe by acquiring our former distributor, MedSupport, on May 4, 2017 and began production of our Inogen One G3 concentrators in the fourth quarter of 2017 using a contract manufacturer located in the Czech Republic to improve our ability to service our European customers.
−Removed: We began manufacturing the Inogen One G5 at our contract manufacturer in the first quarter of 2020.
−Removed: We expect to maintain our assembly operations for our Inogen One concentrators, Inogen At Home concentrators, and Inogen Tidal Assist Ventilators at our facilities in Richardson, Texas and Goleta, California.
+Added: 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.
+Added: We expect to maintain our assembly operations for our products at our facilities in Texas and California.
+Added: In 2021, we plan to focus on reducing the cost of our Inogen One G5 product, expanding manufacturing of the TAV product and our oxygen concentrator products, and increasing the robustness of our supply chain to reduce potential component constraints as we aim to grow our business.
We also use lean manufacturing practices to maximize manufacturing efficiency.
We rely on third-party manufacturers to supply several components of our products.
−Removed: We typically enter into supply agreements for these components that specify quantity and quality requirements and delivery terms.
+Added: We typically enter into master service agreements for these components that specify quantity and quality requirements and delivery terms.
In certain cases, these agreements can be terminated by either party upon relatively short notice.
−Removed: We have elected to source certain key components from single sources of supply, including our batteries, motors, valves, columns, and some molded plastic components.
+Added: We have elected to source certain key components from single sources of supply, including our batteries, motors, valves, TAV-compatible stationary concentrators, columns, and some molded plastic components.
We believe that maintaining a single source of supply allows us to control production costs and inventory levels and to manage component quality.
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Our Quality Management system has been certified to ISO 13485:2016 by BSI, a Notified Body.
−Removed: In 2018 and 2019, our contract manufacturer produced the vast majority of the Inogen One G3 concentrators required to support our European demand and we expect this to continue in 2020, and we also began manufacturing the Inogen One G5 at our contract manufacturer in January 2020.
−Removed: This has allowed us to continue to expand our manufacturing capacity and redirect our U.S.
+Added: In 2018, 2019 and 2020, our contract manufacturer produced the vast majority of the Inogen One G3 concentrators required to support our European demand and we expect this to continue in 2021.
+Added: 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 2020, which we expect to continue in 2021.
+Added: 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.
+Added: 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.
−Removed: and on our latest product, the Inogen One G5.
+Added: and on our latest products, the Inogen One G5 and the TAV.
As of December 31, 2020, we had 242 employees in operations, manufacturing, quality assurance, manufacturing engineering and repair in the United States.
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Our current research and development efforts are focused primarily on increasing functionality, improving design for ease-of-use, and reducing production costs of our Inogen One systems and Inogen At Home systems, as well as developing our next-generation oxygen concentrators and non-invasive ventilators.
−Removed: We have leveraged our forty-six issued patents while also reducing the overall POC system cost by approximately 59% from 2009 to 2019.
+Added: We have leveraged our fifty-nine issued patents while also reducing the overall POC system cost by approximately 59% from 2009 to 2020.
We have released six 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.
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.
−Removed: We launched our Tidal Assist Ventilator in December 2019.
+Added: We launched our TAV in December 2019.
Our dedication to continuous improvement has also resulted in five mid-cycle product updates and numerous incremental improvements.
Development projects utilize a combination of rapid prototyping and accelerated life testing methods to ensure products are taken from concept to commercialization in a fast and capital efficient manner.
−Removed: We leverage our direct patient expertise to rapidly gain insight from end users and to identify areas of innovation that we believe will lead to higher-quality products and lower total cost of ownership for our products.
+Added: We leverage our direct patient expertise to rapidly gain insight from end
+Added: users and to identify areas of innovation that we believe will lead to higher-quality products and lower total cost of ownership for our products.
We continue to focus our efforts on design and functionality improvements that enhance patient quality of life and reduce service costs.
−Removed: The respiratory therapy market is a highly competitive industry.
+Added: The long-term oxygen therapy market and the non-invasive ventilator market are highly competitive industries.
We compete with a number of manufacturers and distributors of portable oxygen concentrators, as well as providers of other long-term oxygen therapy solutions such as home delivery of oxygen tanks or cylinders, stationary concentrators, transfilling concentrators, and liquid oxygen.
−Removed: Our significant manufacturing competitors are Respironics (a subsidiary of Koninklijke Philips N.V.), Invacare Corporation, Caire Medical (subsidiary of NGK Spark Plug), DeVilbiss Healthcare (a subsidiary of Drive Medical), O2 Concepts, Precision Medical, Resmed, Gas Control Equipment (subsidiary of Colfax), Breathe Technologies, Inc.
−Removed: (recently announced to be acquired by Hill-Rom Holdings, Inc.), Breas Medical, Ventec Life Systems, Covidien, and Nidek Medical.
−Removed: Additional competitors have also pre-announced upcoming product launches of portable oxygen concentrators expected in 2020 including 3B Medical, SysMed and Bellascura.
−Removed: Given the relatively low barriers to entry in the oxygen therapy and non-invasive ventilator device manufacturing markets, we expect that the industry will become increasingly competitive in the future.
−Removed: For example, some major manufacturing competitors have implemented direct-to-consumer sales models which may increase their competitiveness and sales to patients;
−Removed: however, these strategies are limited to direct-to-consumer sales and do not include direct-to-consumer rentals where they would be required to meet national accreditation and state-by-state licensing requirements, secure Medicare billing privileges, and compete directly with the home medical equipment providers that many rely on across their entire homecare businesses.
+Added: In the non-invasive ventilator market, we compete with manufacturers and distributors of other portable non-invasive ventilators, as well as HME providers that supply these products.
+Added: Our significant manufacturing competitors are Respironics (a subsidiary of Koninklijke Philips N.V.), Invacare Corporation, Caire Medical (subsidiary of NGK Spark Plug), DeVilbiss Healthcare (a subsidiary of Drive Medical), O2 Concepts, Precision Medical, Resmed, Gas Control Equipment (subsidiary of Colfax), Hill-Rom Holdings, Inc., Breas Medical, Ventec Life Systems, Medtronic, Nidek Medical, and 3B Medical.
+Added: Additional competitors have also pre-announced upcoming product launches of POCs including SysMed and Bellascura.
+Added: Given the relatively straightforward regulatory path in the oxygen therapy and non-invasive ventilator device manufacturing market, we expect that the industry will become increasingly competitive in the future.
+Added: For example, some major competitors have implemented direct-to-consumer sales models, which may increase their competitiveness and sales to patients, and we have recently seen the cost per generated lead trend higher than historical averages, which may be in part due to increased competition.
+Added: 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 required to meet national accreditation and state-by-state licensing requirements and secure insurance contract coverage.
Manufacturing companies compete for sales to providers primarily on the basis of price, quality/reliability, financing, bundling, product features, and service.
−Removed: We believe that we compete favorably with respect to these factors, due to our manufacturing competitors’ reliance on home medical equipment distribution, which compresses their margins and limits their ability to invest in product features that address consumer preferences.
For many years, Lincare , Inc.
−Removed: (a subsidiary of the Linde Group), Apria Healthcare, Inc., AdaptHealth Corp., Aerocare Holdings, Inc, and Rotech Healthcare, Inc.
+Added: (a subsidiary of the Linde Group), Apria Healthcare, Inc., AdaptHealth Corp., and Rotech Healthcare, Inc.
have been among the market leaders in providing respiratory therapy products, while the remaining market is serviced by regional or local providers.
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Some of our competitors are large, well-capitalized companies with significantly greater resources than we have.
−Removed: As a consequence, they are able to spend more aggressively on product development, marketing, sales and other product initiatives than we can.
+Added: Consequently, they are able to spend more aggressively on product development, marketing, sales and other product initiatives than we can.
Some of these competitors have:
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additional lines of products, and the ability to offer rebates or bundle products to offer higher discounts, lower pricing, longer warranties, financing or extended terms, or other incentives to gain a competitive advantage;
−Removed: greater history in conducting research and development, manufacturing, marketing and obtaining regulatory approval for oxygen and non-invasive ventilation products;
−Removed: greater financial and human resources for product development, sales and marketing, patent litigation and customer financing.
−Removed: As a result, our competitors may be able to respond more quickly and effectively than we can to new or changing opportunities, technologies, standards or customer requirements.
−Removed: In light of these advantages that our competitors maintain, even if our technology and direct-to-consumer distribution strategy is more effective than the technology and distribution strategy of our competitors, current or potential customers might accept competitor products and services in lieu of purchasing our products.
+Added: greater history in conducting research and development, manufacturing, marketing and obtaining regulatory approval for respiratory device products;
+Added: greater financial and human resources for, among other things, product development, sales and marketing, and patent litigation.
+Added: As a result, our competitors may be able to respond more quickly and effectively than we can to new or changing opportunities, technologies, standard regulatory and reimbursement development and customer requirements or changing or uncertain business conditions or macroeconomic trends.
+Added: In light of these advantages that our competitors maintain, even if our technology and direct-to-consumer distribution strategy is more effective than the technology and distribution strategy of our competitors, including those who have adopted or may in the future adopt direct-to-consumer sales models, current or potential customers might accept competitor products and services in lieu of purchasing our products.
We anticipate that we will face increased competition in the future as existing companies and competitors develop new or improved products and distribution strategies and as new companies enter the market with new technologies and distribution strategies.
We may not be able to compete effectively against these organizations.
−Removed: Our ability to compete successfully and to increase our market share is dependent upon our reputation for providing high-quality, light weight, and state-of-the-art products with responsive and professional services to achieve strong customer satisfaction.
+Added: Our ability to compete successfully and to increase our market share is dependent upon our reputation for providing responsive, professional and
+Added: high-quality products and services and achieving strong customer satisfaction.
Increased competition in the future could adversely affect our revenue, revenue growth rate, margins and market share.
Government regulation
−Removed: Inogen One systems, Inogen At Home systems, Inogen Tidal Assist Ventilator, 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.
+Added: Inogen One systems, Inogen At Home systems, Inogen TAVs, 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:
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FDA’s pre-market clearance and approval requirements
−Removed: 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 501(k) clearance or a pre-market approval from the FDA.
+Added: 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.
2 unchanged sentences
Some low-risk devices are exempted from this requirement.
−Removed: Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or devices deemed not substantially equivalent to a previously cleared 510(k) device, are placed in Class III, requiring premarket approval.
+Added: Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or devices deemed not substantially equivalent to a previously cleared 510(k) device, are placed in Class III, requiring premarket approval unless they may be marketed under a De Novo authorization from the FDA.
510(k) clearance pathway
−Removed: 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 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.
+Added: 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).
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The FDA must “accept” the submission for substantive review and may require further information, including clinical data, to make a determination regarding substantial equivalence.
−Removed: 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, which is a request to down classify the device from Class III to Class II, or place the device, or the particular use, into Class III.
+Added: 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.
We obtained 510(k) clearance for the original Inogen One system on May 13, 2004.
−Removed: We market the Inogen One G3 and Inogen One G4 systems pursuant to the original Inogen One 510(k) clearance.
+Added: We market the Inogen One G3, Inogen One G4, and Inogen One G5 systems pursuant to the original Inogen One 510(k) clearance.
We obtained 510(k) clearance for the Inogen At Home system on June 20, 2014.
−Removed: New Aera obtained 510(k) clearance for the Tidal Assist Ventilator on December 2, 2016.
+Added: New Aera obtained 510(k) clearance for the TAV on December 2, 2016.
+Added: De Novo authorization pathway
+Added: 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.
+Added: 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
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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.
−Removed: 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.
+Added: 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
+Added: take up to several years.
During this review period, the FDA may request additional information or clarification of the information already provided.
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Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions:
−Removed: warning letters, fines, injunctions, civil or criminal penalties, recall or seizure of our products, operating
−Removed: 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.
+Added: warning letters, fines, injunctions, civil or criminal penalties, recall or seizure of our products, 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.
As a medical device manufacturer, our manufacturing facilities are subject to periodic inspection by the FDA and certain corresponding regulatory agencies and authorities.
−Removed: We have been audited six times since April 2012 by the FDA and found to be in substantial compliance with Good Manufacturing Practices.
−Removed: We have completed six surveillance audits and two recertification audits by our notified body over the same period and identified minor non-conformances, all of which were addressed.
−Removed: In addition, two transfer audits (one combined with a surveillance audit tallied above and one standalone), one unannounced visit, one Medical Device Single Audit Program (MDSAP) upgrade audit, one initial extension of scope audit for Inogen Europe B.V.
−Removed: and one site addition audit were also completed.
+Added: We have been periodically audited by the FDA and found to be in substantial compliance with Good Manufacturing Practices (GMP).
+Added: We have also completed surveillance and recertification audits by our notified body and found to be in substantial compliance with GMP.
International sales of medical devices are subject to foreign government regulations and registration , which may vary substantially from country to country.
−Removed: The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA approval, and the requirements may differ.
+Added: The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA approval /clearance , and the requirements may differ.
There is a trend towards harmonization of quality system standards among the European Union, United States, Canada and various other industrialized countries.
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Loss of any state licensure or operating without a required state license may also impact our Medicare enrollment, which requires us to be properly licensed in every state where we are registered with Medicare to do business.
−Removed: Loss or reprimand of our Medicare enrollment may also affect any Medicare competitive bidding program contracts we may apply for in the future.
+Added: Loss or suspension of our Medicare enrollment may also affect any Medicare competitive bidding program contracts we may apply for in the future.
In addition, we are subject to certain state laws regarding professional licensure.
−Removed: We believe that our certified clinicians are in compliance with all such state laws.
−Removed: If our clinicians were to be found non-compliant in a given state, we would need to modify our approach to providing education, clinical support and customer service in such state.
+Added: We believe that our certified clinicians are in compliance with all applicable state laws.
+Added: If our clinicians were to be found non-compliant in a given state, we would need to modify our approach to providing education, clinical support and customer service in such state until compliance is achieved.
Federal anti-kickback and self-referral laws
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The Federal Anti-Kickback Statute applies to our arrangements with our United States sales representatives, customers and healthcare providers.
−Removed: Although we believe that we have structured such arrangements to be in compliance with the Anti-Kickback Statute and other applicable laws, regulatory authorities may determine otherwise.
−Removed: Non-compliance with the F ederal A nti- K ickback S tatute 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.
−Removed: 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) has a financial relationship, for the furnishing of certain designated health services for which payment may be made by Medicare, unless an exception applies.
+Added: Although we believe that we have structured such arrangements to comply with the Anti-Kickback Statute and other applicable laws, regulatory authorities may determine otherwise.
+Added: 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.
+Added: 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.
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In addition, amendments in 1986 to the Federal False Claims Act have made it easier for private parties to bring “qui tam” or whistleblower lawsuits against companies.
−Removed: Although we believe that we are in compliance with the federal government’s laws and regulations, if we are found in violation of these laws, penalties of up to $0.022 million for each false claim, plus three times the amount of damages that the federal government sustained because of the act, can be assessed.
+Added: Although we believe that we are in compliance with the federal government’s laws and regulations, if we are found in violation of these laws,
+Added: penalties of up to $ 0 .0 2 3 million for each false claim, plus three times the amount of damages that the federal government sustained because of the act , can be assessed .
Civil monetary penalties law
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State fraud and abuse provisions
−Removed: Many states have also adopted some form of anti-kickback and self-referral laws and false claims act that may apply to all payors.
+Added: Many states have also adopted some form of anti-kickback and self-referral laws and false claims act that may apply to DMEPOS suppliers regardless of the payor source.
We believe that we are in compliance with such laws.
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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:
−Removed: 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
−Removed: 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.
+Added: 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.
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As a result, business associates are now subject to significant civil and criminal penalties for failure to comply with applicable standards.
−Removed: Moreover, HITECH creates a new requirement to report certain breaches of unsecured, individually identifiable health information and imposes penalties on entities that fail to do so.
+Added: Moreover, HITECH created a requirement to report certain breaches of unsecured, individually identifiable health information and imposes penalties on entities that fail to do so.
HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney fees and costs associated with pursuing federal civil actions.
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In addition, there has been a recent trend of increased federal and state regulation of payments made to physicians and other healthcare providers.
−Removed: The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, among other things, imposed new 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.
+Added: The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, among other things, 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.
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 $1.177 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.
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Such an assessment may be required in order for a manufacturer to commercially distribute the product throughout these countries.
−Removed: IS O 13485 certification is a voluntary standard.
+Added: ISO 13485 certification is a voluntary standard.
Quality systems that implement relevant harmonized standards establish the presumption of conformity with the essential requirements for a CE Mark.
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Our ISO 13485 certification was issued on April 21, 2005 and our EC-Certificate was issued on March 16, 2007.
−Removed: The final form of the European Medical Device Regulation, which will replace Europe’s Medical Device Directive, entered into force on May 25, 2017 and its full application will be on May 2 6 , 2020 .
+Added: The final form of the European Medical Device Regulation, which will replace Europe’s Medical Device Directive, entered into force on May 25, 2017 and its full application is expected to be on May 26, 2021.
The Medical Device Regulation will apply in parallel with the Medical Device Directive for a transition period of three years.
Inogen has sold products in Canada since 2006 when we obtained our Medical Device License after obtaining appropriate licensure, accreditation, and meeting ISO Standard 13485.
−Removed: As of January 1, 2019, Health Canada implemented the MDSAP as the sole mechanism for manufacturers to demonstrate compliance with the quality management system requirements of the Medical Device Regulations, replacing the Canadian Medical Devices Conformity Assessment System (CMDCAS) program.
−Removed: Inogen complies with MDSAP as of January 1, 2019.
+Added: As of January 1, 2019, Health Canada implemented the Medical Device Single Audit Program (MDSAP) as the sole mechanism for manufacturers to demonstrate compliance with the quality management system requirements of the Medical Device Regulations, replacing the Canadian Medical Devices Conformity Assessment System (CMDCAS) program.
+Added: Inogen has been in compliance with the MDSAP since its implementation on January 1, 2019 and believes it is still in compliance with these regulations.
In Australia, we must appoint an agent sponsor who will interact on our behalf with the Therapeutics Goods Administration (TGA).
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Currently, we require our employees, public accountants, consultants and advisors to execute non-disclosure agreements in connection with their employment, consulting or advisory relationships with us, where appropriate.
−Removed: 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 work day, developed using our property or related to our business.
+Added: 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.
−Removed: As of December 31, 2019, we had twenty-eight pending patent applications and forty-six issued patents relating to the design and construction of our respiratory devices.
+Added: As of December 31, 2020, we had twenty-nine pending patent applications and fifty-nine 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.
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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.
−Removed: For example, U .
−Removed: p atent 9,592,360 is directed to the Inogen One G3 design, while U .
−Removed: patent 9,283,346 is directed towards the Inogen at Home stationary oxygen concentrator.
+Added: For example, U.S.
+Added: patents 9,592,360 and 10,786,644 are directed to the Inogen One G3 design, U.S.
+Added: patent 10,695,520 is directed to the design of the Inogen One G4, and U.S.
+Added: patents 9,283,346;
+Added: 10,004,869 and 10,869,986 are directed towards the Inogen at Home stationary oxygen concentrator.
This category of patents expires in 2031 or later and may serve to deter competitors from reverse engineering or copying our design elements.
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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.
−Removed: The fourth category of patents and patent applications is directed to the Tidal Assist Ventilator and related products.
+Added: The fourth category of patents and patent applications is directed to the TAV and related products.
For example, U.S.
−Removed: patent 10,384,028 is directed to the nasal interface of the Tidal Assist Ventilator.
+Added: patent 10,384,028 is directed to the nasal interface of the TAV.
Another example of a patent in this category is U.S.
−Removed: patent D851,767 which is directed to the design of the Tidal Assist Ventilator.
+Added: patent D851,767 which is directed to the design of the TAV.
This category of patents expires in 2034 or later.
−Removed: “Inogen,” “Inogen One,” “Inogen One G2,” “Inogen One G3,” “G4,” “G5,” “Oxygenation,” “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” are registered trademarks with the United States Patent and Trademark Office of Inogen, Inc.
−Removed: We own pending applications for “Inogen,” “MOMENTUM TRANSFER” and “SONIC BLADE” with the United States Patent and Trademark Office.
−Removed: We own trademark registrations for the mark “Inogen” in Australia, Canada, South Korea, Mexico, Europe (European Union Registration), Iceland, India, Israel, Japan, New Zealand, Norway, Peru, Turkey, Singapore, and Switzerland.
−Removed: We own pending applications for the mark “Inogen” in Argentina, Brazil, Chile, China, Columbia, Ecuador, Kuwait, Malaysia, Paraguay, South Africa and Uruguay.
+Added: “Inogen,” “Inogen One,” “Inogen One G2,” “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” are registered trademarks with the United States Patent and Trademark Office of Inogen, Inc.
+Added: We own a pending application for “Inogen” with the United States Patent and Trademark Office.
+Added: We own trademark registrations for the mark “Inogen” in Argentina, Australia, Canada, Chile, China, Columbia, Ecuador, South Korea, Mexico, Europe (European Union registration), the United Kingdom, Iceland, India, Israel, Japan, Kuwait, New Zealand, Norway, Paraguay, Peru, Turkey, Singapore, and Switzerland.
+Added: We own pending applications for the mark “Inogen” in Brazil, India, Malaysia, South Africa, and Uruguay.
We own a trademark registration for the mark “イノジェン” in Japan.
−Removed: We own trademark applications for the marks “ 印 诺 真 ” and “ 艾 诺 根 ” in China.
+Added: 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, and Europe (European Union registration).
−Removed: We own a trademark registration for the mark “Satellite Conserver” in Canada.
−Removed: We own a trademark registration for the mark “Inogen At Home” in Europe (European Union Registration).
+Added: trademark registration for the mark “Satellite Conserver” in Canada.
+Added: 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.
−Removed: We own trademark applications for the Inogen design in Bolivia and China.
+Added: We own a trademark application for the Inogen design in Bolivia.
+Added: We own a trademark registration for the Inogen design in China.
+Added: We own a trademark registration for the mark “ إنوجن ” in Saudi Arabia.
Other service marks, trademarks, and trade names referred to in this Annual Report on Form 10- K are the property of their respective owners.
−Removed: As of December 31, 2019, we had 1,020 full and part-time employees worldwide, representing 526 in sales, marketing, clinical and client services, 301 in operations, manufacturing, quality assurance, manufacturing engineering, and repair, 167 in general administration and 26 in research and development.
−Removed: None of our employees are represented by a collective bargaining agreement.
−Removed: We believe that our employee relations are good.
+Added: Human capital
+Added: At Inogen, we believe our employees are critical to our success and our ability to focus on product quality, continuous improvement, and outstanding customer satisfaction.
+Added: The unique demands of our industry, together with the challenges of running an enterprise focused on the development, manufacture and commercialization of innovative products, require talent that is highly educated and/or has significant industry experience.
+Added: Additionally, for certain key functions, we require specific expertise to oversee and conduct research and development activities and complex manufacturing requirements for our products.
+Added: We seek the best people we can find and support them to be productive and engaged.
+Added: We strive to ensure our measures of safety, remuneration and employee engagement are competitive with those of leading companies in our industry.
+Added: As of December 31, 2020, we had 938 full and part-time employees worldwide, consisting of 505 employees in sales, marketing, clinical and client services, 242 employees in operations, manufacturing, quality assurance, manufacturing engineering, and repair, 164 employees in general administration and 27 employees in research and development.
+Added: In addition, we had 105 temporary workers as of December 31, 2020, primarily in operations, to support spikes in demand.
+Added: None of our employees are represented by a collective bargaining agreement and we believe that our employee relations are good.
+Added: Employee culture
+Added: Inogen strives to instill a culture that values honesty and ethics, which is why integrity is one of Inogen’s five core values.
+Added: We expect our employees to honor commitments and take ownership of mistakes and we expect our employees to always do the right thing not the easy thing.
+Added: In addition, Inogen values self-responsibility, open communication, continuous improvement and service, which are all important components of our culture.
+Added: 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:
+Added: http://investor.inogen.com/ .
+Added: 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.
+Added: 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.
+Added: 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.
+Added: In addition, we believe our commitment to environmental, social, and governance (ESG) initiatives is important to our customers, patients, employees, suppliers, and investors, and shows our commitment towards improved global health.
+Added: Our ESG strategy is grounded in business sustainability, our Code of Ethics and Conduct, and our core values.
+Added: Talent acquisition and development
+Added: Inogen employees have specific career and development pathways, which are designed in consultation with the employee’s operational management and human resources.
+Added: We encourage 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.
+Added: As part of our commitment to career development and learning, we perform an annual affirmative action review by job role for all Inogen employees, and we have a policy to address identified pay or promotion discrepancies that are not based on experience or skill.
+Added: Diversity, equity and inclusion
+Added: Diversity, equity and inclusion are essential elements of Inogen’s business practices.
+Added: 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.
+Added: 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.
+Added: We embrace employees’ diversity of background, experience, culture, and other characteristics that make employees unique.
+Added: 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.
+Added: 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”.
+Added: 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.
+Added: 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.
+Added: Inogen has implemented policies, procedures, and trainings to ensure that any reports of potential discrimination or harassment are appropriately investigated and corrected.
+Added: Health and safety
+Added: 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.
+Added: Inogen also has a corporate wellness program to promote improved physical and emotional wellbeing.
+Added: In response to the COVID-19 pandemic and related PHE and as part of our commitment to work to ensure the safety and well-being of our employees, our employees who are able and choose to work from home have done so since mid-March 2020.
+Added: For employees returning to the workplace and the field, we have also taken additional safety measures, including implementing occupancy limits, restricting business travel, providing and requiring the use of personal protective equipment, temperature screening and COVID-19 testing to access our workplaces.
Environmental matters
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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.
−Removed: 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.
+Added: 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.
+Added: Additionally, a s 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.
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Our website address is www.inogen.com .
−Removed: We make available on our website, free of charge, our Annual Report 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 Securities and Exchange Commission, or SEC.
+Added: 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
+Added: amendments to those reports, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission, or SEC.
Our SEC reports can be accessed through the investor relations page of our website located at http://investor.inogen.com .
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The following table identifies certain information about our executive officers as of February 19, 2021.
−Removed: Scott Wilkinson
+Added: Nabil Shabshab
Chief Executive Officer, President, and Director
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Executive Vice President, Engineering
−Removed: Executive Vice President, Sales and Marketing
−Removed: Scott Wilkinson has served as our President and Chief Executive Officer since March 1, 201 7 and a director since January 1, 2017.
+Added: Executive Vice President, Marketing
+Added: Arron Retterer
+Added: Executive Vice President, Sales
+Added: Nabil Shabshab has served as our President, Chief Executive Officer, and as a director since February 8, 2021.
Previously, Mr.
−Removed: Wilkinson served as our President and Chief Operating Officer from January 1, 2016 through February 28, 2017, Executive Vice President, Sales and Marketing from 2008 through December 31, 2015, and in this role oversaw Inogen’s global operations in sales, marketing, customer service, product management, medical billing, and clinical services.
−Removed: Prior to that, Mr.
−Removed: Wilkinson served as our Director of Product Management from 2005 to 2006 and Vice President, Product Management from 2006 to 2008.
−Removed: From 2000 to 2005, Mr.
−Removed: Wilkinson worked for Invacare Corporation, a designer and manufacturer of oxygen products, as a Group Product Manager and helped launch their $100 million oxygen product line segment.
−Removed: From 1999 to 2000, Mr.
−Removed: Wilkinson served as a Product Line Director with Johnson & Johnson, a healthcare company.
+Added: 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.
+Added: Previously, from 2006 to 2010, Mr.
+Added: Shabshab served as EVP, Global Portfolio, Chief Marketing Officer and Head of RD&E of Diversey, Inc., a cleaning and sanitation solutions company.
+Added: Prior to that, from 2004 to 2006, Mr.
+Added: Shabshab served as Principal of The Zyman Group, a marketing consulting firm.
From 2002 to 2004, Mr.
−Removed: Wilkinson worked as a Research Scientist, Product Manager, and Project Leader at Kimberly Clark, a consumer products company.
−Removed: Wilkinson received a Bachelor of Science degree in Chemical Engineering from the University of Akron and an MBA from University of Wisconsin, Oshkosh.
−Removed: The b oard of d irectors believes that Mr.
−Removed: Wilkinson’s considerable knowledge and understanding of our business together with his extensive industry experience qualifies him to serve on the b oard.
+Added: Shabshab served as Vice President, Client Solutions and Consulting, of Symphony IRI, a consumer marketing firm.
+Added: Prior to that, Mr.
+Added: Shabshab served in various sales and marketing roles in pharmaceutical and consumer goods companies.
+Added: Shabshab holds an MBA from Northwestern University Kellogg School of Management and a B.S.
+Added: in Computer Sciences from American Lebanese University.
+Added: The board of directors believes that Mr.
+Added: Shabshab’s extensive industry experience qualifies him to serve on the board.
Alison Bauerlein is a co-founder of Inogen and has served as our Chief Financial Officer since 2009 and Executive Vice President, Finance since March 2014.
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Taylor served as our Vice President, Engineering from 2008 until March 2014 and as the Director of Technology with our company from 2003 to 2008.
−Removed: Taylor is listed as an inventor on 29 of the Company’s issued patents related to portable oxygen concentrator development.
+Added: Taylor is listed as an inventor on 33 of the Company’s issued patents related to
+Added: portable oxygen concentrator development.
Taylor received a Bachelor of Science degree in Microbiology from the University of California, Santa Barbara.
−Removed: Byron Myers is a co-founder of Inogen and has served as our Executive Vice President, Sales and Marketing since January 1, 2017.
+Added: Byron Myers is a co-founder of Inogen and has served as our Executive Vice President, Marketing since August 2020.
Previously, Mr.
−Removed: Myers served as our Vice President, Marketing from 2011 to 2016.
+Added: Myers served as our Executive Vice President, Sales and Marketing from January 1, 2017 until August 2020 and served as our Vice President, Marketing from 2011 to 2016.
In his current role, Mr.
−Removed: Myers leads Inogen’s sales, marketing and product management operations.
+Added: Myers leads Inogen’s marketing, product management, and clinical operations.
Prior to serving in these positions, Mr.
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Myers received a Bachelor of Arts degree in Economics/Mathematics from the University of California, Santa Barbara and an MBA from the Rady School of Management at the University of California, San Diego.
+Added: Arron Retterer has served as our Executive Vice President, Sales since August 2020.
+Added: Retterer was the Global Platform Leader for V.
+Added: Mueller Surgical Instruments (Becton Dickinson) from June 2016 to October 2019.
+Added: From October 2010 to May 2016, Arron served as the National Vice President, Sales, for several medical device divisions of BD/Carefusion, including V.
+Added: Mueller/Snowden-Pencer Surgical Instruments, Airlife Respiratory and Inside Sales.
+Added: From August 2000 to September 2010 Arron served in various escalating sales roles with the V.
+Added: Mueller/Snowden-Pencer Surgical Instrument business.
+Added: Retterer received a Master of Science from University of Oregon and a Bachelor of Science from the University of Arizona.
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.