Insulet (PODD) 10-K risk factor changes: FY2022 vs FY2021
The 2022-12-31 10-K against the 2021-12-31 one, compared heading by heading and sentence by sentence.
Item 1A144 rewritten26 added55 removed272 unchanged
All filing items848 rewritten483 added361 removed1,460 unchanged
Summary
counted, not written
- Item 1A lists 37 risk factor headings: 4 new, 2 reworded and 31 unchanged since FY2021. 4 headings from FY2021 no longer appear.
- Sentence by sentence, 483 added, 361 removed, 848 rewritten and 1,460 unchanged across 13 items that differ.
New Item 1A headings (4)
- Our failure to compete effectively would negatively impact our revenue.
- We are dependent upon third-party suppliers, making us vulnerable to supply problems and price fluctuations, and we may not be able to obtain sufficient components or raw materials on a timely basis at all.
- Our manufacturing process is highly complex and subject to regulation; as demand for our products increase, we may experience manufacturing difficulties, including not effectively managing the start-up of new manufacturing lines or issues with our third-party contract manufacturer, which could harm our business.
- If we fail to comply with Medicare, Medicaid, fraud and abuse, and other healthcare regulations, we could be subject to substantial penalties and/or be excluded from participation in government programs.
Removed Item 1A headings (4)
- We face competition from numerous competitors, many of whom have far greater resources than we have, and, as a result, we may not be able to compete effectively.
- If we are unable to obtain sufficient components or raw materials on a timely basis or if we experience manufacturing difficulties, including not effectively managing the start-up of new manufacturing lines, our business may be harmed.
- We are dependent upon third-party suppliers, making us vulnerable to supply problems and price fluctuations.
- The medical device industry is heavily regulated. If we fail to comply with all applicable laws and government regulations, we could be subject to substantial penalties and/or be excluded from participation in government programs.
Reworded Item 1A headings (2)
- If we do not effectively manage our [added: rapid] growth, our business resources may become strained and we may not be able to deliver the Omnipod System in a timely manner, which could harm our results of operations.
- Our financial condition and results of operations have been and may to continue to be adversely affected by the COVID-19
[removed: pandemic.][added: pandemic and worldwide economic issues, such as inflation.]
A heading is new when no FY2021 heading matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. All current risk factor headings.
Sentences by item
22 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2022; struck-through words were in FY2021. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. Risk Factors
144 rewritten, 26 added, 55 removed, 272 unchanged
- [removed: the] failure of the Omnipod System to achieve and maintain wide acceptance among opinion leaders in the diabetes treatment community, insulin-prescribing physicians, third-party payors, and people with insulin-dependent diabetes;
- competitive pricing; [removed: and]
- results of clinical studies relating to the Omnipod System or our competitors’ [removed: products.][added: products; and]
If any of these events occurs, our ability to generate revenue could be significantly reduced, which would adversely affect our business, financial [removed: condition] [added: condition,] and results of operations.
We have developed retention programs aimed at both healthcare professionals and consumers, which include appeals assistance, ongoing customer communications, newsletters, support, [removed: training] [added: training,] and an automatic re-order program for certain customers.
The failure to retain a high percentage of our customers could negatively impact our revenue growth and may have a material adverse effect on our business, financial [removed: condition] [added: condition,] and results of operations.
If we do not effectively manage our [added: rapid] growth, our business resources may become strained and we may not be able to deliver the Omnipod System in a timely manner, which could harm our results of operations.
As we continue to expand [removed: our sales,] [added: the number of customers] we [added: serve, driven in large part by significant demand for Omnipod 5, we] expect to continue to increase our manufacturing capacity, our [removed: personnel] [added: personnel,] and the scope of our sales and marketing efforts.
This growth, as well as any other growth that we may experience in the future, will provide challenges to our organization and may strain our management and operations [removed: resources.][added: resources, including our customer service.]
In order to manage future growth, we will be required to improve existing, and implement new, sales and marketing [removed: efforts and] [added: efforts,] distribution [removed: channels.][added: channels, and customer support procedures.]
We will [added: also] need to manage our supply chain [added: and manufacturing] effectively, including [removed: the continued development of] our [removed: manufacturing and our relationships with our contract manufacturer and other suppliers.][added: sourcing of materials such as semiconductor chips.]
If we cannot scale our business appropriately, maintain control over expenses or otherwise adapt to anticipated and unanticipated growth, our business resources may become strained, we may not be able to deliver the Omnipod System in a timely [removed: manner] [added: manner,] and our results of operations may be adversely affected.
Failure to secure or retain adequate coverage or reimbursement for our products by third-party payors could adversely affect our business, financial [removed: condition] [added: condition,] and results of operations.
We expect that sales of the Omnipod [removed: System] [added: System, which, in the U.S., occur only through the pharmacy channel for Omnipod 5 and primarily through the pharmacy channel for Omnipod DASH,] will be limited unless a substantial portion of the sales price of the Omnipod System is paid for by third-party payors, including private insurance companies, health maintenance organizations, preferred provider organizations, federal and state government healthcare [removed: agencies] [added: agencies, intermediaries, Medicare, Medicaid] and other managed care providers.
[removed: In] the [removed: United States, we currently have contracts establishing reimbursement for the] Omnipod System with national and regional third-party payors [added: and government agencies] that provide reimbursement in all 50 states.
While we anticipate entering into additional contracts with other [added: intermediaries and] third-party payors, we cannot assure you that our efforts will be [removed: successful.][added: successful, which could limit the availability of the Omnipod System.]
Moreover, compliance with administrative procedures or requirements of third-party payors may result in delays in processing approvals by those payors for consumers to obtain coverage for the use of the Omnipod [removed: System.][added: System and for payment to be made for such use.]
[removed: As a result, we must negotiate] [added: Medicare Part D Plan Sponsors may provide coverage for the Omnipod System under the Medicare Part D prescription drug program, which requires negotiating] with third-party payors in order to provide our product through the pharmacy channel in the United [removed: States to users who are covered under Medicare Part D.][added: States.]
Failure to secure or retain adequate coverage or reimbursement for the Omnipod System by third-party payors could have a material adverse effect on our business, financial [removed: condition] [added: condition,] and results of operations.
Efforts to control healthcare costs, including limiting access to care, alternative delivery [removed: models] [added: models,] and changes in the methods used to determine reimbursement scenarios and rates, are ongoing at the federal and state government levels.
Risks Related to [added: Competition,] Product [removed: Development, Market Access] [added: Development] and [removed: Competition][added: Intellectual Property]
[removed: In addition to the established insulin pump competitors, several] [added: Several] companies are working to develop and market new insulin “patch” pumps, smart pens, and other methods for the treatment of diabetes.
[removed: Some] [added: In addition, some] of our [removed: competitors] [added: competitors, such as Medtronic and Roche,] are large, well-capitalized companies with more resources than we have.
- established relations with healthcare professionals, [removed: customers] [added: customers,] and third-party payors;
- greater experience in conducting research and development, clinical trials, manufacturing, [removed: marketing] [added: marketing,] and obtaining regulatory approval; and
[removed: While we believe that] [added: MDI therapy, including smart pens, can be substantially less expensive than] pump therapy, [removed: in general,] and [removed: the Omnipod System, in particular, have significant competitive and clinical advantages over MDI therapy,] improvements in the effectiveness of MDI therapy may result in fewer people with insulin-dependent diabetes converting from MDI therapy to pump therapy than we [removed: expect and may] [added: expect, which could] result in [removed: negative] price [removed: pressure.][added: pressure and decreased revenue.]
[removed: If these competitors’ products were to gain acceptance by healthcare] professionals, people with insulin-dependent [removed: diabetes] [added: diabetes,] or third-party payors, we could experience pricing pressure.
Technological breakthroughs in diabetes monitoring, [removed: treatment] [added: treatment,] or prevention could render the Omnipod System obsolete.
The Omnipod System is based on our proprietary technology, but a number of companies, medical [removed: researchers] [added: researchers,] and pharmaceutical companies are pursuing new delivery devices, delivery technologies, sensing technologies, procedures, [removed: drugs] [added: drugs,] and other therapeutics for the monitoring, [removed: treatment] [added: treatment,] and/or prevention of insulin-dependent diabetes.
[removed: Medtronic commercially launched a “hybrid closed-loop” system in 2017, and] [added: For example,] in 2020 Tandem launched an AID system, [added: with] which [added: Omnipod 5 competes directly, and which] could negatively impact our business.
In addition, the National Institutes of Health and other supporters of diabetes research are continually seeking ways to prevent, [removed: cure] [added: cure,] or improve the treatment of diabetes.
Any technological breakthroughs in diabetes monitoring, [removed: treatment] [added: treatment,] or prevention could render the Omnipod System obsolete, which would have a material adverse effect on our business, financial [removed: condition] [added: condition,] and results of operations.
[removed: We may be] [added: If we are] unable to [removed: effectively] introduce and market new products [removed: or may fail to] [added: and] keep pace with advances in [removed: technology.][added: technology, our business will be negatively impacted.]
Even if we can develop, [removed: manufacture] [added: manufacture,] and obtain regulatory and reimbursement approvals for our new products, the success of those products depends on market acceptance.
Our failure to introduce new and innovative products in a timely manner could have a material adverse effect on our business, results of operations, financial [removed: condition] [added: condition,] and cash flows.
We rely on third parties, such as contract research organizations, medical institutions, clinical investigators, contract [removed: laboratories] [added: laboratories,] and other third parties to conduct some of our clinical trials and pre-clinical investigations.
[added: If these third parties do] not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, or if the quality or accuracy of the data they obtain is compromised due to failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our pre-clinical development activities or clinical trials may be extended, delayed, [removed: suspended] [added: suspended,] or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize, our products on a timely basis, or at all, and our business and operating results may be adversely affected.
Future market or clinical studies may be unfavorable to the Omnipod System and its efficacy, which could hinder our sales efforts and have a material adverse effect on our business, results of operations, financial [removed: condition] [added: condition,] and cash flows.
To help improve, [removed: market] [added: market,] and sell the Omnipod System, we have sponsored, and expect to continue to sponsor market studies to assess various aspects of the Omnipod System’s functionality and its relative efficacy.
If future clinical trials fail to support the efficacy of our current or future products, our sales may be adversely affected and we may lose an opportunity to secure clinical preference from prescribing clinicians, which may have a material adverse effect on our business, financial [removed: condition] [added: condition,] and results of operations.
- development of an effective patch pump by one or more competitors.
In the United States, we currently have contracts establishing reimbursement for
Our failure to compete effectively would negatively impact our revenue.
We compete with companies that produce insulin pumps, such as Medtronic, Tandem, The Ypsomed Group and Roche Diabetes Care, Inc (“Roche”).
In addition to the established insulin pump competitors, we compete with companies that provide products and supplies for MDI therapy.
If these competitors’ products were to gain acceptance by healthcare
measures to protect our intellectual property rights.
We may not be able to develop additional proprietary technologies that are patentable, and we cannot ensure that our pending patent applications will result in the issuance of patents to us.
We also cannot ensure that patents issued to, or licensed by or to, us in the past or in the future will not be challenged or circumvented by competitors.
While not a part of our business plans or operations, we have been involved in patent infringement suits in the past, including as disclosed in Note 17 to the consolidated financial statements included in Item 8.
As our revenue increases, the number of companies with whom we compete grows and the functionality of products and technology in different industry segments overlaps, the risk of third-party infringement claims increases.
glucose levels.
While the UK and the European Union entered into a Trade and Cooperation Agreement, a number of areas are still unsettled, and it is
Our policies mandate compliance with these anti-bribery laws.
For example, given the recent worldwide semiconductor chip shortage, we have entered into “take or pay” contracts with suppliers but cannot guarantee our suppliers will meet their obligations under these contracts.
We have also seen significant price increases for various components and raw materials, including for semiconductor chips.
Our manufacturing process is highly complex and subject to regulation; as demand for our products increase, we may experience manufacturing difficulties, including not effectively managing the start-up of new manufacturing lines or issues with our third-party contract manufacturer, which could harm our business.
Obtaining 510(k) clearance or PMA can be expensive and lengthy, and we may not be able to obtain them in a timely fashion or at all.
As described elsewhere in this 10-K, in October and November 2022, we issued voluntary Medical Device Corrections (“MDCs”) relating to the batteries and/or charging of our DASH PDMs and Omnipod 5 Controllers, which are manufactured for us by a third-party.
letter, injunction, seizure, civil fine, or criminal penalties.
In addition, data security protection laws passed by the federal government and many states
We recently experienced a data security incident impacting a subset of our customers in which the impacted customer’s IP address, and whether the customer was a Omnipod DASH user and has a PDM, were inadvertently shared with website performance and marketing partners of Insulet through website “cookies” and other trackers.
These trackers have since been disabled, and no financial information, social security numbers, email addresses, or passwords were exposed.
All affected customers and relevant authorities were notified, and we did not view this as a material event.
of other transactions.
Additionally, in December 2022 and February 2023, we acquired intangible assets from Automated Glucose Control LLC (“AGC”) and Bigfoot, which provided us important intellectual property.
We are an approved Medicare supplier and CMS has issued guidance clarifying that Medicare Part D Plan Sponsors may provide coverage for products such as the Omnipod System under the Medicare Part D prescription drug program.
Compliance with administrative procedures or requirements of these third-party payors may result in delays in processing approvals by those payors for consumers to obtain Medicare Part D coverage for the use of the Omnipod System.
Medicaid coverage decisions are made by the governing authorities in each state.
As the Medicaid coverage process and stakeholders are unique to each state, the timeline to gain coverage in each state may vary.
We began our full market release of Omnipod DASH in 2019, primarily through the pharmacy channel, which required negotiation of new or amended agreements with our intermediaries and payors.
The availability of Omnipod DASH may be limited or restricted if we are unable to maintain these agreements and sustain an adequate level of reimbursement under these agreements.
The ACA and related healthcare reform laws, regulations and initiatives have significantly increased regulation of managed care plans and decreased reimbursement to Medicare managed care.
Some of these initiatives purport to, among other things, require that health plan members have greater access to drugs not included on a plan’s formulary.
Moreover, to alleviate budget shortfalls, states have reduced or frozen payments to Medicaid managed care plans.
We face competition from numerous competitors, many of whom have far greater resources than we have, and, as a result, we may not be able to compete effectively.
The medical device industry is intensely competitive, subject to rapid change resulting from technological advances and scientific discoveries as well as other market activities of industry participants.
The Omnipod System competes with several existing insulin delivery devices as well as other methods for the treatment of diabetes.
We also compete with Medtronic and Tandem, among others.
Medtronic has been the insulin pump market leader for many years.
These companies are at various stages of development and the number of such companies continuously changes as they enter or exit the market on an ongoing basis.
We also compete with MDI therapy, including smart pens, which is substantially less expensive than pump therapy.
For example, FDA approval of a commercially viable “closed-loop” or “hybrid closed-loop” system that combines continuous “real-time” glucose sensing or monitoring and automatic continuous subcutaneous insulin infusion in a manner that delivers appropriate amounts of insulin on a timely basis with reduced user direction could have a material adverse effect on our revenue and future profitability.
We have ongoing initiatives to develop products to improve the treatment of type 1 and type 2 diabetes.
The success of our business depends on our ability to introduce new products and adapt to these changing technologies and consumer demands.
If these third parties do
Our success depends in part on our ability to maintain the proprietary nature of our technologies.
We may not be able to develop additional proprietary technologies that are patentable.
If we are unable to sufficiently protect our intellectual property rights and our intellectual property is disclosed or misappropriated, our competitiveness could be impaired, which would limit our growth and future revenue.
We operate in an industry characterized by extensive patent litigation.
We have settled infringement suits in the past and as disclosed in Note 17 to the consolidated financial statements included in Item 8, we are currently subject to patent infringement litigation with Roche Diabetes Care, Inc. In addition, we expect that we could be increasingly subject to third-party infringement claims as our revenue increases, the number of competitors grows and the functionality of products and technology in different industry segments overlaps.
The COVID-19 pandemic has created significant volatility, uncertainty and economic disruption in the markets we sell our products into and operate in and negatively impacted business and healthcare activity globally.
- changes in regulatory requirements;
The effects of Brexit will depend on the terms of the U.K.’s future relationship with the European Union.
If we are unable to obtain sufficient components or raw materials on a timely basis or if we experience manufacturing difficulties, including not effectively managing the start-up of new manufacturing lines, our business may be harmed.
We acquire our components and materials from many suppliers in various countries.
We rely on suppliers who manufacture the components for and perform assembly of the Pods and PDMs.
We may not be able to quickly establish additional or alternative suppliers, particularly for our sole-source suppliers, in part because of the FDA approval process and because of the custom nature of various parts.
An interruption or delay in obtaining products from our third-party suppliers, or our inability to obtain products from alternate sources at acceptable prices in a timely manner, could impair our ability to meet the demand of our customers and cause them to cancel orders or switch to competing products.
In December 2012, we received 510(k) clearance for our Omnipod Insulin Management System.
We have since obtained clearance for modified versions of this device, including Omnipod DASH, which was cleared by the FDA in 2018 and Omnipod 5, which was cleared by the FDA in January 2022.
Obtaining 510(k) clearance or PMA for medical devices can be expensive and lengthy, and entail significant user fees.
Further, we may not be able to obtain additional 510(k) clearances or PMAs for new products or for modifications to, or additional indications for, the Omnipod System in a timely fashion or at all.
Any change in the laws or regulations that govern
harm our reputation.
The medical device industry is heavily regulated.
An excerpt. Shown here: 40 of 144 rewritten, all 26 added and 40 of 55 removed. The counts are complete. For every sentence, read Item 1A. Risk Factors in the FY2022 filing and the FY2021 filing.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
102 rewritten, 120 added, 99 removed, 109 unchanged
The following discussion may contain forward-looking statements that reflect our plans, [removed: estimates] [added: estimates,] and beliefs, which are subject to risks, [removed: uncertainties] [added: uncertainties,] and assumptions.
We are primarily engaged in the development, [removed: manufacture] [added: manufacture,] and sale of our proprietary Omnipod System, a continuous insulin delivery system for people with insulin-dependent diabetes.
The Omnipod System features a small, lightweight, self-adhesive disposable tubeless Omnipod device that [removed: is worn] [added: the user fills with insulin and wears directly] on the body for up to three days at a [removed: time;] [added: time, which delivers personalized doses of insulin,] and [removed: its wireless companion,] the [added: PDM or Controller, a wireless] handheld [removed: PDM/Controller.][added: device that programs the Pod with the user’s personalized insulin-delivery instructions and wirelessly monitors the Pod’s operation.]
[removed: Most] [added: In addition, substantially all] of our [removed: drug delivery] [added: Drug Delivery] revenue [removed: currently] consists of sales of pods to Amgen for use in the Neulasta® Onpro® kit, a delivery system for Amgen’s Neulasta to help reduce the risk of infection after intense chemotherapy.
To achieve this goal, our efforts have been focused on the launch of Omnipod 5, which [removed: recently] [added: in 2022] received FDA clearance for individuals aged [removed: six] [added: two] years and older with type 1 diabetes.
[removed: We have also recently] [added: In 2022, we] completed our [added: Omnipod 5] type 2 [added: diabetes] feasibility study and plan to [removed: conduct additional studies] [added: begin a pivotal trial in 2023] with the goal [removed: to further expand] [added: of expanding] Omnipod 5’s indication to type 2 users.
We have also [removed: taken] [added: been taking] steps to [removed: strengthen] [added: continue strengthening] our global manufacturing capabilities.
[removed: Further, we] [added: We] are [added: also] working to bring Omnipod 5 to our international markets.
The discussion of our results of operations for [removed: 2019] [added: 2020] has been omitted from this Form 10-K but can be found in Item 7.
Management’s Discussion and Analysis and Results of Operations in our Form 10-K for the fiscal year ended December 31, [removed: 2020] [added: 2021] filed with the Securities and Exchange Commission on February 24, [removed: 2021.][added: 2022.]
As we grow our customer base, we [added: expect to] generate an increasing portion of our [removed: revenue] [added: revenues] through recurring sales of our [added: disposable] Pods, which provides [removed: consistent cash flow.][added: recurring revenue.]
We have also experienced and [removed: may] [added: expect to] continue to experience challenges stemming from the global supply chain [removed: disruption;] [added: disruption that began during the coronavirus pandemic (“COVID-19”);] however, to date we have been able to successfully mitigate [removed: any disruption.][added: this disruption and ensure uninterrupted supply to our customers by increasing our inventory levels and taking other measures.]
Comparison of the Years Ended December 31, [removed: 2021] [added: 2022] and December 31, [removed: 2020][added: 2021]
| (In millions) | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | % Change | | | | | | Currency Impact | | | | | | Constant Currency(1) | | |
| U.S. Omnipod | | | $ | [removed: 651.5] [added: 884.8] | | | | | $ | [removed: 526.9] [added: 651.5] | | | | | [removed: 23.6] [added: 35.8] | | % | | | | — | | % | | | | [removed: 23.6] [added: 35.8] | | % |
| Drug Delivery | | | [removed: 87.4] [added: 57.5] | | | | | | [removed: 69.5] [added: 87.4] | | | | | | [removed: 25.8] [added: (34.2)] | | % | | | | — | | % | | | | [removed: 25.8] [added: (34.2)] | | % |
Total revenue for [removed: 2021] [added: 2022] increased [removed: $194.4] [added: $206.5] million, or [removed: 21.5%,] [added: 18.8%,] to [removed: $1,098.8] [added: $1,305.3] million, compared with [removed: $904.4] [added: $1,098.8] million in [removed: 2020.][added: 2021.]
Constant currency revenue growth of [removed: 19.7%] [added: 22.2%] was primarily driven by higher volume and, to a lesser extent, favorable sales channel mix.
U.S. Omnipod revenue for [removed: 2021] [added: 2022] increased [removed: $124.6] [added: $233.3] million, or [removed: 23.6%,] [added: 35.8%,] to [removed: $651.5] [added: $884.8] million, compared with [removed: $526.9] [added: $651.5] million in [removed: 2020.][added: 2021.]
This increase was primarily due to higher [added: Omnipod 5 and Omnipod DASH] volumes driven by growing our customer base and, to a lesser extent, [removed: an increase due to] growth through the pharmacy channel, where Pods have a higher average selling price [removed: from our pay-as-you-go pricing model] [added: due] in [removed: which] [added: part to the fact that] we offer the [removed: PDM] [added: PDM/Controller] for no charge.
Additional information regarding our related party transactions is provided in Note [removed: 5.][added: 5 to our consolidated financial statements.]
In [removed: 2022,] [added: 2023,] we expect strong Omnipod revenue growth driven by continued volume growth of Omnipod [removed: DASH, primarily] [added: 5] in the pharmacy [removed: channel.][added: channel, continued adoption of Omnipod DASH, and the benefits of our recurring revenue model.]
International Omnipod revenue for [removed: 2021] [added: 2022] increased [removed: $51.9] [added: $3.1] million, or [removed: 16.9%,] [added: 0.9%,] to [removed: $359.9] [added: $363.0] million, compared with [removed: $308.0] [added: $359.9] million in [removed: 2020.][added: 2021.]
Excluding the [removed: 5.3% favorable] [added: 11.2% unfavorable] impact of currency exchange, the remaining [removed: 11.6%] [added: 12.1%] increase was primarily due to higher volumes as we continue to expand awareness and access to [removed: the Omnipod,] [added: Omnipod DASH,] partially offset by [removed: the normalization of inventory][added: increased competition from AID systems.]
In [removed: 2022,] [added: 2023,] we expect higher International Omnipod revenue due to continued volume growth [removed: and market penetration aided] [added: driven] by the ongoing adoption of Omnipod [removed: DASH throughout our international markets.][added: DASH, partially offset by competition from AID systems and an unfavorable impact of currency exchange.]
Drug Delivery revenue for [removed: 2021 increased $17.9] [added: 2022 decreased $29.9] million, or [removed: 25.8%,] [added: 34.2%,] to [removed: $87.4] [added: $57.5] million, compared with [removed: $69.5] [added: $87.4] million in [removed: 2020.][added: 2021.]
This [removed: increase] [added: decrease] was primarily driven by [removed: increased] [added: a decline in] production volume due to [removed: higher] [added: lower] demand from our partner.
| Cost of revenue | | | $ | [removed: 346.7] [added: 499.7] | | | | | [removed: 31.6] [added: 38.3] | | % | | | | $ | [removed: 322.1] [added: 346.7] | | | | | [removed: 35.6] [added: 31.6] | | % |
| Research and development expenses | | | $ | [removed: 160.1] [added: 180.2] | | | | | [removed: 14.6] [added: 13.8] | | % | | | | $ | [removed: 146.8] [added: 160.1] | | | | | [removed: 16.2] [added: 14.6] | | % |
| Selling, general and administrative expenses | | | $ | [removed: 466.0] [added: 587.8] | | | | | [removed: 42.4] [added: 45.0] | | % | | | | $ | [removed: 384.0] [added: 466.0] | | | | | [removed: 42.5] [added: 42.4] | | % |
Cost of revenue for [removed: 2021] [added: 2022] increased [removed: $24.6] [added: $153.0] million, or [removed: 7.6%,] [added: 44.1%,] to [removed: $346.7] [added: $499.7] million, compared with [removed: $322.1] [added: $346.7] million in [removed: 2020.][added: 2021.]
Gross margin was [removed: 68.4%] [added: 61.7%] in [removed: 2021,] [added: 2022,] compared with [removed: 64.4%] [added: 68.4%] in [removed: 2020.][added: 2021.]
We expect gross margin for [removed: 2022] [added: 2023] to be in the range of [removed: 67%] [added: 65%] to [removed: 68%.][added: 66%.]
We [removed: anticipate gross margin] [added: believe these increases] will be [removed: negatively impacted] [added: partially offset] by [added: continued higher production costs as we further scale U.S. manufacturing,] unfavorable product [removed: mix,] [added: line mix due to] higher costs associated with Omnipod 5 production, and [removed: continued] higher [removed: production] costs as we [removed: further scale U.S. manufacturing, and] contend with [removed: inflation and global supply chain disruptions.][added: inflation.]
Research and development expenses for [removed: 2021] [added: 2022] increased [removed: $13.3] [added: $20.1] million, or [removed: 9.1%,] [added: 12.6%,] to [removed: $160.1] [added: $180.2] million, compared with [removed: $146.8] [added: $160.1] million in [removed: 2020.][added: 2021.]
This increase was primarily due to year-over-year headcount additions to support our continued investment in development of Omnipod [removed: products.][added: products, partially offset by lower outside services used for clinical activities.]
We expect research and development spending in [removed: 2022] [added: 2023] to increase compared with [removed: 2021] [added: 2022] as we continue to invest in advancing our innovation and clinical pipeline and contend with inflation.
Selling, general and administrative expenses for [removed: 2021] [added: 2022] increased [removed: $82.0] [added: $121.8] million, or [removed: 21.4%,] [added: 26.1%,] to [removed: $466.0] [added: $587.8] million, compared with [removed: $384.0] [added: $466.0] million in [removed: 2020.][added: 2021.]
We expect selling, general and administrative expenses to increase in [removed: 2022] [added: 2023] compared with [removed: 2021] [added: 2022] due to [removed: expansion of our sales force and customer support personnel,] investments [removed: to expand market acceptance and access for the Omnipod System, including direct-to-consumer advertising, and investments] in our operating structure to facilitate operational efficiencies and continued [removed: growth.][added: growth, including customer support and a new enterprise]
Interest expense, net for [removed: 2021 increased $16.1] [added: 2022 decreased $34.5] million, or [removed: 35.7%,] [added: 56.4%,] to [removed: $61.2] [added: $26.7] million, compared with [removed: $45.1] [added: $61.2] million in [removed: 2020.][added: 2021.]
The Omnipod System, includes: Classic Omnipod, its next generation Omnipod DASH, and the most recent generation Omnipod 5, all of which eliminate the need for multiple daily injections using syringes or insulin pens or the use of pump and tubing.
Omnipod DASH features a secure Bluetooth enabled Pod and PDM with a color touch screen user interface supported by smartphone connectivity.
Omnipod 5, which builds on our Omnipod DASH mobile platform, is a tubeless automated insulin delivery system, that integrates with a continuous glucose monitor (“CGM”) to manage blood sugar and is fully controlled by a compatible personal smartphone or Omnipod 5 Controller.
The CGM is sold separately by a third party.
Our limited market release of Omnipod 5 in the United States began in the first quarter, and in the third quarter we launched our U.S. full market release.
We recently received CE Mark approval under the European MDR, and we are currently focused on further building our international teams and advancing our regulatory, reimbursement, and market development efforts.
We plan to launch Omnipod 5 in the U.K. and Germany in 2023 and to continue our international roll out more broadly in 2024.
Additionally, to accelerate our efforts to secure reimbursement for Omnipod 5, we have fully enrolled individuals in a randomized control trial in the U.S. and enrollment will begin soon in France.
We also continue to expand market access and awareness of Omnipod through our direct to consumer advertising programs and through growing our presence in the U.S. pharmacy channel, where access to Omnipod 5 and Omnipod DASH is simpler and affordable, as no up-front investment is required.
As we continue our growth in the pharmacy channel, we plan to phase-out our Classic Omnipod in the U.S. in 2023, since the vast majority of our customer base is no longer using this product.
Additionally, we continue to increase our presence within our existing markets and expand internationally in a targeted and strategic manner.
We opened an office in Dubai to serve as our primary local presence and regional infrastructure in the Middle East, launched Omnipod in Saudi Arabia, and expanded into the United Arab Emirates.
We are optimizing our operations in China by consolidating our production in that region into one location.
Further, in 2022 we broke ground on a new manufacturing plant in Malaysia to support our international expansion strategy, further ensure product supply, and drive higher gross margins over time.
We expect to begin production at this new manufacturing facility in 2024.
Finally, we continue to focus on our product development efforts, including AID offerings, such as choice of continuous glucose monitor and smartphone integration, and enhancing the customer experience through digital product and data capabilities.
We have also developed a basal-only Pod for individuals with type 2 diabetes and submitted our 510(k) application to the FDA in November.
We expect commercialization of the basal-only Pod in 2024.
We recently achieved a milestone of 360,000 estimated global customers using Omnipod, including over 100,000 U.S. customers using the Omnipod 5.
During 2022, we issued two voluntary MDCs, one in October for our Omnipod DASH PDM related to its battery and the other in November for our Omnipod 5 Controller related to the charging port and cable.
In addition to the estimated liability we recorded in 2022, we have a performance obligation to replace Omnipod DASH PDMs and Omnipod 5 Controllers sold subsequent to the MDC issuances, which is expected to negatively impact gross margins and net income in 2023, most notably in the first half of the year.
While our mitigation efforts and inflation have and are expected to continue to negatively impact gross margins and net income in 2023, we intend to continue to work to improve productivity to help offset these costs.
| International Omnipod | | | 363.0 | | | | | | 359.9 | | | | | | 0.9 | | % | | | | (11.2) | | % | | | | 12.1 | | % |
| Total Omnipod | | | 1,247.8 | | | | | | 1,011.4 | | | | | | 23.4 | | % | | | | (3.6) | | % | | | | 27.0 | | % |
| Total | | | $ | 1,305.3 | | | | | $ | 1,098.8 | | | | | 18.8 | | % | | | | (3.4) | | % | | | | 22.2 | | % |
Existing customer conversions to Omnipod 5 also contributed to the revenue increase as some users fill both their starter kit and their first month of refills simultaneously.
U.S. Omnipod revenue for 2022 includes $249.9 million of related party revenue, compared with $58.2 million in 2021.
The $191.7 million increase primarily resulted from a shift in certain revenues from one distributor to another as we worked to extend our reach through the pharmacy channel.
In 2023, we expect Drug Delivery revenue to decline due to a lower demand forecast from our partner.
| | | | 2022 | | | | | | | | | | | | 2021 | | | | | | | | |
The 6.7 point decrease in gross margin was primarily driven by a $57.9 million net charge, or 4.5 points, associated with the voluntary MDCs we issued in 2022.
The decrease was also driven by higher expected production costs in the U.S. as manufacturing continues to ramp and become a larger portion of our total production and higher costs associated with Omnipod 5 production.
These decreases were partially offset by higher average selling price due to growth in the pharmacy channel, where Pods have a higher average selling price due in part to the fact that we offer the PDM/Controller for no charge.
We anticipate gross margin to increase due to significant costs associated with the MDCs in 2022, most of which we do not expect to recur in 2023 and higher volume in the pharmacy channel and favorable geographical sales mix.
This increase was primarily attributable to year-over-year headcount additions, mainly to support information technology and commercial operations and $25.2 million of legal charges related to the settlement of a patent infringement lawsuit, associated legal fees, and the settlement of a contract dispute.
To a lesser extent, these increases were due to an increase in investments to expand market acceptance and access to Omnipod, higher travel and entertainment expenses due to increased activity as COVID-19 restrictions have lifted, an increase in software license fees driven by investments in new systems to support our growing business and headcount additions, and higher amortization of cloud computing implementation costs.
Additionally, selling, general and administrative expenses include $3.4 million of costs associated with the retirement and advisory services of our former chief executive officer.
These increases were partially offset by a decrease in direct-to-consumer advertising resulting from the timing of spend.
resource planning system.
Additionally, we plan to make investments to support the Omnipod System, including market acceptance and access, and the phased launch of Omnipod 5 in our international markets.
The Omnipod System, which features discreet and easy-to-use devices, communicates wirelessly, provides for virtually pain-free automated cannula insertion and eliminates the need for MDI therapy or the use of pump and tubing.
We believe that the Omnipod System’s unique proprietary design and features allow people with insulin-dependent diabetes to manage their diabetes with unprecedented freedom, comfort, convenience and ease.
In addition to the diabetes market space, we have partnered with pharmaceutical and biotechnology companies to tailor the Omnipod System technology platform for the delivery of subcutaneous drugs across other therapeutic areas.
To assist in achieving this mission, we are focused on the following key strategic imperatives:
- expanding access and awareness;
- delivering consumer-focused innovation;
- growing our global addressable market; and
- driving operational excellence.
Our limited market release of Omnipod 5 is underway.
Additionally, we have completed our FDA submission to expand Omnipod 5’s indication down to age two, and are planning for an expanded indication in 2022.
In our efforts to bring Omnipod 5 to international markets, we have submitted for CE Marking in Europe under MDR.
In order to support our continued growth and the full commercial launch of Omnipod 5, we continue to focus on adding capacity to our U.S. manufacturing plant.
During 2021, we began producing salable product on our third highly automated manufacturing line.
We have optimized our operations in China by consolidating our production in that region into one location and we plan to invest in a new manufacturing plant in another international location to further diversify globally and increase efficiency to drive higher gross margins over time.
In 2021, we completed our full commercial launch of Omnipod DASH, our digital mobile Omnipod platform, in the countries we serve with our roll out in Canada.
Over the long term, we expect the introduction of Omnipod DASH throughout our international markets to be a growth driver as we increase our presence within our existing markets and enter into new countries.
We are continuing to expand internationally in a targeted and strategic manner.
During 2021, we increased our global footprint by expanding into Turkey and entered the Asia Pacific region with our launch in Australia.
In 2022.
we expect to enter additional countries in the Middle East.
Finally, we plan to continue to expand awareness of and access to our products, while also focusing on our product development efforts.
The latter includes enhancing the customer experience through digital product offerings.
Achieving the above strategic imperatives is expected to require additional investments in certain initiatives and personnel, as well as enhancements to our supply chain operation capacity, efficiency and effectiveness.
We recently achieved a milestone of approximately 300,000 global customers using Omnipod.
During 2020 and 2021, we were subject to challenging conditions stemming from the coronavirus pandemic (“COVID-19” or the “pandemic”).
Containment efforts and responses to the pandemic have varied by individuals, businesses, state and local municipalities, and region.
We believe people were less likely to change the way they manage their diabetes during the pandemic for a variety of reasons including temporary closure of doctors’ offices or a general unwillingness to visit a doctor’s office or hospital during the pandemic, particularly since those with diabetes are deemed at higher risk of suffering complications from COVID-19.
While the pandemic had a negative impact on new customer starts and the effects will not be fully reflected in our results of operations and overall financial performance until future periods, we believe our overall recurring revenue model provides a solid financial foundation for strong cash flow generation.
Further, the pandemic had a positive impact on our Drug Delivery revenue.
See “Risk Factors” in Part I, Item 1A of this Annual Report for further discussion of the possible impact of the COVID-19 pandemic on our business.
| International Omnipod | | | 359.9 | | | | | | 308.0 | | | | | | 16.9 | | % | | | | 5.3 | | % | | | | 11.6 | | % |
| Total Omnipod | | | 1,011.4 | | | | | | 834.9 | | | | | | 21.1 | | % | | | | 1.9 | | % | | | | 19.2 | | % |
| Total | | | $ | 1,098.8 | | | | | $ | 904.4 | | | | | 21.5 | | % | | | | 1.8 | | % | | | | 19.7 | | % |
This increase was partially offset by the normalization of inventory levels at distributors, which were elevated in the prior year due to the launch of Omnipod DASH.
This increase was partially offset by the impact of the pandemic on our recurring revenue.
U.S. Omnipod revenue for 2021 includes $58.2 million of related party revenue that resulted from a shift in certain revenues from one distributor to another.
levels at distributors, which were elevated in the prior year due to the launch of Omnipod DASH and the impact of the pandemic on our recurring revenue.
We expect this revenue growth to be partially offset by competition from AID systems and the impact of the pandemic on our recurring revenue.
In 2022, we expect Drug Delivery revenue to decline as production levels that were elevated during the pandemic normalize.
| | | | 2021 | | | | | | | | | | | | 2020 | | | | | | | | |
An excerpt. Shown here: 40 of 102 rewritten, 40 of 120 added and 40 of 99 removed. The counts are complete. For every sentence, read Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in the FY2022 filing and the FY2021 filing.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
7 rewritten, 1 added, 0 removed, 16 unchanged
At December 31, [removed: 2021,] [added: 2022,] no amounts were outstanding under our Revolving Credit Facility.
A 100 basis point increase or decrease in interest rates [removed: relative to interest rates] as of December 31, [removed: 2021] [added: 2022] would decrease or increase our annual earnings, respectively, by approximately [removed: $0.2] [added: $0.1] million.
As of December 31, [removed: 2021,] [added: 2022,] we had outstanding debt related to our convertible senior notes recorded on our consolidated balance sheet of [removed: $638.8] [added: $788.8] million, net of unamortized discount and issuance costs totaling [removed: $161.2] [added: $11.2] million.
The fair value of the convertible senior notes, which was [removed: $938.8] [added: $1,038.7] million as of December 31, [removed: 2021,] [added: 2022,] is also impacted by changes in our stock price.
[removed: We expect the Capped Calls to reduce the potential dilution to our common stock] (or, in the event the conversion is settled in cash, to provide a source of cash to settle a portion of our cash payment obligation) in the event that at the time of conversion our stock price exceeds the conversion price under the 0.375% Notes.
Approximately [removed: 33%] [added: 28%] of our revenue was denominated in foreign currencies for the year ended December 31, [removed: 2021.][added: 2022.]
Net realized and unrealized gains (losses) from foreign currency transactions are included in other (expense) income, net in the consolidated statement of [removed: income] [added: operations] and amounted to a loss of [removed: $2.0] [added: $1.3] million for the year ended December 31, [removed: 2021.][added: 2022.]
We expect the Capped Calls to reduce the potential dilution to our common stock
Item 1. Business
99 rewritten, 50 added, 50 removed, 279 unchanged
The Omnipod System includes: the Omnipod Insulin Management System [removed: (“Omnipod”),] [added: (“Classic Omnipod”),] the Omnipod DASH® Insulin Management System (“Omnipod DASH”), [removed: our digital mobile Omnipod platform] and the Omnipod® 5 Automated Insulin Delivery System (“Omnipod 5”).
[removed: Most] [added: In addition, substantially all] of our [removed: drug delivery] [added: Drug Delivery] revenue consists of sales of pods to Amgen for use in the Neulasta® Onpro® kit, a delivery system for Amgen’s Neulasta to help reduce the risk of infection after intense chemotherapy.
We estimate that approximately [removed: four to four and a half] [added: five] million people have type 1 diabetes in the countries we currently serve.
We estimate that approximately [removed: seven to seven and a half] [added: six] million people have [removed: insulin-requiring] [added: insulin-intensive] type 2 diabetes in the countries we currently serve.
We estimate that approximately [removed: one-third] [added: 40%] of the type 1 diabetes population in the United States and even less of the international type 1 diabetes population use insulin pump therapy.
An even smaller portion of the U.S. and international [removed: insulin-requiring] [added: insulin-intensive] type 2 diabetes population use insulin pump therapy.
Throughout this Annual Report on Form 10-K, we refer to both type 1 diabetes and [removed: insulin-requiring] [added: insulin-intensive] type 2 diabetes as insulin-dependent diabetes.
In addition to basal insulin, people with insulin-dependent diabetes require supplemental insulin, known as bolus insulin, to compensate for carbohydrates ingested during meals or snacks or for a high blood glucose level caused by [added: other physiological reasons.]
For example, insulin pump therapy eliminates individual insulin [removed: injections (approximately five per day),] [added: injections,] delivers insulin more accurately and precisely than injections, often improves HbA1c (a common measure of blood glucose levels) over time, provides greater flexibility with meals, exercise, and daily schedules, and can reduce severe low blood glucose levels.
| [removed: ] [added: ] | | | [removed: ] [added: ] | | | [added:  | | |]
The Pod delivers [removed: precise, personalized doses of] insulin into the body through a small flexible tube (called a cannula); and
- the Personal Diabetes Manager (“PDM”) or Controller, a wireless, handheld device that programs the Pod with the user’s personalized insulin-delivery instructions [removed: and,] [added: and] wirelessly monitors the Pod’s operation.
Omnipod DASH was fully launched in the United States in 2019 and in our [removed: existing] international markets [added: starting] in [removed: 2020 and 2021.][added: 2020.]
[removed: It features a secure Bluetooth enabled Pod and] [added: In the U.S., the] PDM [removed: with a color touch screen user interface supported by smartphone connectivity,] [added: has] nightly automatic data uploads providing users and their clinicians with cloud access to data, and enhancements for pushing software updates wirelessly to users.
[removed: In January 2022, we received clearance from the U.S. Food and Drug Administration’s (“FDA”) for the commercial distribution of] Omnipod 5, which builds on our Omnipod DASH [removed: mobile platform.][added: platform, was cleared by the U.S. Food and Drug Administration (“FDA”) in January 2022.]
Omnipod 5 includes an AID algorithm that is located on [added: the Pod.]
The Pod integrates with a third-party [removed: continuous glucose monitor (“CGM”)] [added: CGM] to obtain glucose [removed: values.][added: values trough wireless Bluetooth communication.]
The embedded algorithm [removed: then] predicts glucose levels into the future and automatically adjusts insulin dosing intended to [added: achieve user selected glucose targets and] reduce the occurrence of blood glucose highs and lows.
The Pod is controllable by an Insulet-provided handheld device (Controller) or a user-downloaded Android app, which allows for full compatible smartphone [removed: control and currently integrates with a CGM manufactured by Dexcom, Inc. In February, we commenced a limited market release of Omnipod 5 in the U.S.][added: control.]
[removed: The] Omnipod [removed: System] [added: DASH] provides continuous insulin delivery at preset rates, eliminating the need for individual insulin injections.
We have designed [removed: the] Omnipod [removed: System] [added: DASH] to fit within the normal daily routines of users.
[removed: The] Omnipod [removed: System] [added: DASH] communicates wirelessly, provides for virtually pain-free automated cannula insertion, and eliminates the need for MDI therapy or the use of pump and tubing.
As a result, [removed: the] Omnipod [removed: System] [added: DASH] is easy to use, which reduces the training burden on healthcare professionals and users.
We believe that [removed: the] Omnipod [removed: System’s] [added: DASH’s] overall ease of [removed: use, flexibility,] [added: use] and [removed: substantially lower training burden] [added: flexibility] make it very attractive to people with insulin-dependent diabetes and [removed: allows] [added: their] healthcare [removed: professionals to prescribe pump therapy to a broader group of people with diabetes.][added: professionals.]
In addition, Insulet’s information security management system is International Organization for Standardization (“ISO”) 27001 [added: and 27701] certified, which [removed: is] [added: are] the international standard for best practice in an information security management system globally.
With the DTSec and ISO [removed: 27001] certifications, Insulet is globally recognized for incorporating the highest standards for cybersecurity and information security and safety, including secure data transfer between the Pod and PDM, as well as secure cloud storage.
[removed: We] [added: Further, we] have partnered with Glooko Inc. (“Glooko”) to connect our Omnipod System user data with Glooko’s comprehensive diabetes data management system (including Glooko and Diasend in selected regions).
In the United States, our products are sold [removed: directly] to [removed: consumers, as well as] wholesalers, private healthcare organizations, healthcare facilities, mail order pharmacies, and independent [removed: retailers.][added: retailers, as well as directly to consumers.]
[removed: party] [added: The Omnipod System’s unique patented design allows us to provide pump therapy at a relatively low or no up-front investment, which reduces the risk to third-party] payors in the U.S. In certain international locations in which we sell through a distributor or intermediary, our distribution partners and local intermediaries establish appropriate reimbursement contracts with healthcare systems in those countries and provinces.
The Omnipod System is currently available in the following [added: 24] countries:
| Canada | | | Greece | | | Norway | | | United [removed: Kingdom] [added: Arab Emirates] | | |
| Croatia | | | Iceland | | | Qatar | | | United [removed: States] [added: Kingdom] | | |
For the year ended December 31, [removed: 2021, 76%] [added: 2022, 84%] of our Omnipod System sales were through intermediaries.
| | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |
| Distributor [removed: A] [added: C] | | | [removed: 10%] [added: *] | | | | | | [removed: 11%] [added: 10%] | | | | | | [removed: *] [added: 11%] | | |
| Distributor B | | | [removed: 12%] [added: 17%] | | | | | | [removed: 10%] [added: 12%] | | | | | | [removed: 11%] [added: 10%] | | |
- Strengthening physician support by demonstrating [removed: the] clinical evidence of how the Omnipod [removed: system] [added: System] improves outcomes and quality of [removed: life,] [added: life] and providing data and insights to physicians offering diabetes care.
[removed: With the launch of Omnipod DASH, we] [added: We] created an online training program for Omnipod customers transitioning to Omnipod DASH or Omnipod 5.
Because most new Omnipod System users come from MDI therapy, which currently is the most prevalent method of insulin delivery, we believe that we [added: primarily compete with companies that provide products and supplies for MDI therapy.]
[removed: Medtronic historically has held the] majority share of the tubed insulin pump market.
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Omnipod DASH | | | Omnipod 5 | | | | | |
Additionally, Omnipod 5 is interoperable with a third-party continuous glucose monitor (“CGM”) sold separately that obtains glucose values and integrates with the Pod.
Omnipod DASH
It features a secure Bluetooth enabled Pod and PDM with a color touch screen user interface supported by smartphone connectivity.
Omnipod DASH delivers insulin in two ways:
Omnipod 5
Our limited market release of Omnipod 5 in the United States commenced the following month, and in August 2022 we launched our U.S. full market release.
In September 2022, we received CE Mark approval for Omnipod 5 under the European Union Medical Device Regulation (“MDR”).
The user can also deliver insulin doses for snacks or meals or to correct high blood glucose through the system.
The Omnipod 5 Controller and Omnipod 5 Android app use cloud-based technology to wirelessly upload data using a built-in SIM card for cellular connectivity or from a secure Wi-Fi connection if established.
The Pod currently integrates with a CGM manufactured by Dexcom, Inc.
Subsequent to the launch of Omnipod 5, the vast majority of our customer base is no longer using our Classic Omnipod product.
We plan to phase-out our Classic Omnipod product in the U.S. in 2023.
Security
| Denmark | | | Israel | | | Saudi Arabia | | | United States | | |
| Distributor A | | | 19% | | | | | | * | | | | | | * | | |
| Distributor D | | | 16% | | | | | | * | | | | | | * | | |
In addition, our virtual training allows us to onboard new Omnipod customers transitioning from MDI in a cost-effective manner.
Medtronic historically has held the
In 2022, we received FDA clearance for Omnipod 5 for individuals aged two years and older with type 1 diabetes and received CE Mark approval for Omnipod 5 under the European Union MDR.
We plan to begin a pivotal trial for Omnipod 5 in 2023 with the goal of expanding Omnipod 5’s indications to individuals with type 2 diabetes.
Additionally, in November 2022, we submitted our 510(k) application to the FDA for a basal-only Pod for individuals with type 2 diabetes, which is a version of Omnipod specifically designed for customers on basal-only therapy.
The basal-only Pod is designed to deliver a fixed rate of rapid-acting insulin for 72 continuous hours and does not require a PDM/Controller or phone application for use.
The Acton facility increases supply redundancy and adds capacity closer to our North American customer base to support the growth of our business.
Additionally, in 2022, we broke ground on a new manufacturing plant in Malaysia to support our international expansion strategy and further ensure product supply.
least dual sourced.
Recent Intellectual Property Agreements
Bigfoot.
In February 2023, we entered into a Patent Assignment and License Agreement with Bigfoot Biomedical, Inc. (“Bigfoot”), pursuant to which we acquired approximately 400 patents as well as a significant number of global patent applications, and licensed a large number of additional patents and patent applications on a fully paid-up exclusive or non-exclusive basis.
Medtronic.
In October 2022, we entered into a mutual agreement with Medtronic, Inc., not to assert our patents against each other for certain technologies in the field of diabetes.
With certain exclusions, this agreement applies to the companies’ existing products, as well as new products for at least the next seven years.
No payments have been or will be exchanged as part of the agreement.
The agreement replaces and terminates the Settlement and Cross License Agreement, dated September 18, 2013, by and between us and Medtronic.
A clinical trial may be suspended by the FDA or at a
Liability
CPRA enforcement is scheduled to begin on July 1, 2023.
The Consumer Data Protection Act became effective in Virginia on January 1, 2023, and the Colorado Privacy Act is effective July 1, 2023.
In addition to the diabetes market space, we have partnered with pharmaceutical and biotechnology companies to tailor the Omnipod System technology platform for the delivery of subcutaneous drugs across other therapeutic areas.
other physiological reasons.
| | | | | | |
| --- | --- | --- | --- | --- | --- |
the Pod.
The Omnipod System works like the pancreas of a person without diabetes by delivering insulin in two ways:
The Omnipod System consists of just two devices as opposed to up to seven for tubed insulin pumps.
Several publications over the past decade have found that compared to MDI therapy, the use of the Omnipod System by individuals with both type 1 and type 2 diabetes across all age groups is associated with good glycemic control and reduced frequency and severity of hypoglycemic episodes.
These results are consistent with published literature of other continuous subcutaneous insulin infusion devices.
In addition, research in adults with type 1 diabetes has found that compared to prior treatment modality, the use of the Omnipod System is associated with improved quality of life.
We believe that this data is clinically meaningful to healthcare providers and provides support for the use of the Omnipod System in the treatment of both type 1 and type 2 diabetes.
The Omnipod System’s unique patented design allow us to provide pump therapy at a relatively low or no up-front investment, which reduces the risk to third-
| Denmark | | | Israel | | | | | | | | |
In addition, due to the challenges COVID-19 has presented, we have also been using virtual training to onboard new Omnipod customers transitioning from MDI.
Our virtual capabilities have allowed us to continue to onboard new customers despite COVID-19 in a cost-effective manner.
primarily compete with companies that provide products and supplies for MDI therapy.
Throughout 2021, we worked to receive FDA clearance for Omnipod 5 for individuals aged six years and older with type 1 diabetes, which was obtained in January 2022.
In 2021, we also completed our Omnipod 5 clinical study of pediatric users ages two to six years old, and in 2022, we filed for clearance of this expanded indication.
We have also filed for CE Mark approval of Omnipod 5.
During 2021, we completed our Omnipod 5 feasibility study for individuals with type 2 diabetes, and we plan to conduct additional studies with the goal of expanding Omnipod 5’s indications.
In addition to increasing supply redundancy and adding capacity closer to our North American customer base to support the growth of our business, we expect that once the Acton facility is operating at full capacity, the highly automated assembly process will be able to produce a globally cost competitive product.
Additionally, we plan to invest in a new manufacturing plant in another international location to further diversify globally and increase efficiency.
In the case
In addition, we
providing reimbursement assistance, coding and billing information, or other customer assistance and product support programs.
California.
Some of the provisions of the ACA have yet to be fully implemented, and certain provisions have been subject to judicial and Congressional challenges.
In addition, there have been efforts to repeal or replace certain aspects of the ACA and to alter the implementation of the ACA and related laws.
It is unclear how the ACA and its implementation, as well as efforts to repeal or replace, or invalidate, the ACA, or portions thereof, will affect our business.
Moreover, these laws continue to evolve.
The Bipartisan Budget Act of 2018 increased the criminal and civil penalties that can be imposed for violating certain federal healthcare laws, including the Anti‑Kickback Statute.
Additionally, in late 2020, the United States Department of Health and Human Services’ Office of the Inspector General (“OIG”) finalized a rule that will remove protection from the discount safe harbor to the federal healthcare Anti-Kickback Statute for manufacturers rebates to pharmacy benefit managers (or “PBMs”), Medicare Part D plans and Medicaid managed care organizations (“MCOs”), effective January 2022.
The rule also includes a new safe harbor for point-of-sale reductions offered by manufacturers to Part D plans, Medicaid MCOs and their PBMs, and a new safe harbor for certain fees manufacturers pay to PBMs for services to the manufacturers.
The rule was finalized consistent with an Executive Order issued by the President in 2020; with the change in Administrations, it is possible that the rule may be revised before it is fully effective.
If it takes effect as written, the rule will be one of the most significant amendments to the Anti-Kickback Statute regulatory safe harbors in decades and likely will transform manufacturer interactions with Part D plans, Medicaid MCOs and their PBMs.
anti-bribery laws may conflict with local customs and practices.
In 2021, we heard from employees through a variety of surveys focused on wellness, work-life balance, and the workplace of the future.
In 2022, we implemented a new approach to engagement.
This initiative also includes virtual meetings with our executive team members.
These virtual meetings are designed as casual conversations with our executives so
An excerpt. Shown here: 40 of 99 rewritten, 40 of 50 added and 40 of 50 removed. The counts are complete. For every sentence, read Item 1. Business in the FY2022 filing and the FY2021 filing.
Cover and table of contents
25 rewritten, 5 added, 5 removed, 59 unchanged
| | | | For the fiscal year ended | | | December 31, [removed: 2021] [added: 2022] | | |
The aggregate market value of the common stock held by non-affiliates of the registrant computed by reference to the last reported sale price of the Common Stock as reported on The NASDAQ Global Market on June 30, [removed: 2021] [added: 2022] was approximately [removed: $18.8] [added: $15.1] billion.
The number of shares of common stock outstanding as of February [removed: 17, 2022] [added: 16, 2023] was [removed: 69,217,620.][added: 69,542,257.]
The registrant intends to file a proxy statement pursuant to Regulation 14A within 120 days of the end of the fiscal year ended December 31, [removed: 2021.][added: 2022.]
| Item 1 | | | [removed: [Business](#iee3984e984b04607a7931c48e89c96c7_13)] [added: [Business](#i0c69bee1b7c6495895ec2961d1c58cdb_13)] | | | [removed: [3](#iee3984e984b04607a7931c48e89c96c7_13)] [added: [3](#i0c69bee1b7c6495895ec2961d1c58cdb_13)] | | |
| Item 1A | | | [Risk [removed: Factors](#iee3984e984b04607a7931c48e89c96c7_16)] [added: Factors](#i0c69bee1b7c6495895ec2961d1c58cdb_16)] | | | [removed: [15](#iee3984e984b04607a7931c48e89c96c7_16)] [added: [15](#i0c69bee1b7c6495895ec2961d1c58cdb_16)] | | |
| Item 1B | | | [Unresolved Staff [removed: Comments](#iee3984e984b04607a7931c48e89c96c7_19)] [added: Comments](#i0c69bee1b7c6495895ec2961d1c58cdb_19)] | | | [removed: [30](#iee3984e984b04607a7931c48e89c96c7_19)] [added: [29](#i0c69bee1b7c6495895ec2961d1c58cdb_19)] | | |
| Item 2 | | | [removed: [Properties](#iee3984e984b04607a7931c48e89c96c7_22)] [added: [Properties](#i0c69bee1b7c6495895ec2961d1c58cdb_22)] | | | [removed: [30](#iee3984e984b04607a7931c48e89c96c7_22)] [added: [29](#i0c69bee1b7c6495895ec2961d1c58cdb_22)] | | |
| Item 3 | | | [Legal [removed: Proceedings](#iee3984e984b04607a7931c48e89c96c7_25)] [added: Proceedings](#i0c69bee1b7c6495895ec2961d1c58cdb_25)] | | | [removed: [30](#iee3984e984b04607a7931c48e89c96c7_25)] [added: [29](#i0c69bee1b7c6495895ec2961d1c58cdb_25)] | | |
| Item 4 | | | [Mine Safety [removed: Disclosures](#iee3984e984b04607a7931c48e89c96c7_28)] [added: Disclosures](#i0c69bee1b7c6495895ec2961d1c58cdb_28)] | | | [removed: [30](#iee3984e984b04607a7931c48e89c96c7_28)] [added: [29](#i0c69bee1b7c6495895ec2961d1c58cdb_28)] | | |
| Item 5 | | | [Market for [removed: Registrant's] [added: Registrant](#i0c69bee1b7c6495895ec2961d1c58cdb_34)’[s] Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#iee3984e984b04607a7931c48e89c96c7_34)] [added: Securities](#i0c69bee1b7c6495895ec2961d1c58cdb_34)] | | | [removed: [31](#iee3984e984b04607a7931c48e89c96c7_34)] [added: [30](#i0c69bee1b7c6495895ec2961d1c58cdb_34)] | | |
| Item 6 | | | [removed: [Reserved](#iee3984e984b04607a7931c48e89c96c7_37)] [added: [Reserved](#i0c69bee1b7c6495895ec2961d1c58cdb_37)] | | | [removed: [32](#iee3984e984b04607a7931c48e89c96c7_37)] [added: [31](#i0c69bee1b7c6495895ec2961d1c58cdb_37)] | | |
| Item 7 | | | [removed: [Management's] [added: [Management](#i0c69bee1b7c6495895ec2961d1c58cdb_40)’[s] Discussion and Analysis of Financial Condition and Results of [removed: Operations](#iee3984e984b04607a7931c48e89c96c7_40)] [added: Operations](#i0c69bee1b7c6495895ec2961d1c58cdb_40)] | | | [removed: [33](#iee3984e984b04607a7931c48e89c96c7_40)] [added: [32](#i0c69bee1b7c6495895ec2961d1c58cdb_40)] | | |
| Item 7A | | | [Quantitative and Qualitative Disclosures About Market [removed: Risk](#iee3984e984b04607a7931c48e89c96c7_64)] [added: Risk](#i0c69bee1b7c6495895ec2961d1c58cdb_61)] | | | [removed: [40](#iee3984e984b04607a7931c48e89c96c7_64)] [added: [40](#i0c69bee1b7c6495895ec2961d1c58cdb_61)] | | |
| Item 8 | | | [Financial Statements and Supplementary [removed: Data](#iee3984e984b04607a7931c48e89c96c7_67)] [added: Data](#i0c69bee1b7c6495895ec2961d1c58cdb_64)] | | | [removed: [41](#iee3984e984b04607a7931c48e89c96c7_67)] [added: [41](#i0c69bee1b7c6495895ec2961d1c58cdb_64)] | | |
| Item 9 | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#iee3984e984b04607a7931c48e89c96c7_157)] [added: Disclosure](#i0c69bee1b7c6495895ec2961d1c58cdb_166)] | | | [removed: [71](#iee3984e984b04607a7931c48e89c96c7_157)] [added: [73](#i0c69bee1b7c6495895ec2961d1c58cdb_166)] | | |
| Item 9A | | | [Controls and [removed: Procedures](#iee3984e984b04607a7931c48e89c96c7_160)] [added: Procedures](#i0c69bee1b7c6495895ec2961d1c58cdb_169)] | | | [removed: [71](#iee3984e984b04607a7931c48e89c96c7_160)] [added: [73](#i0c69bee1b7c6495895ec2961d1c58cdb_169)] | | |
| Item 9B | | | [Other [removed: Information](#iee3984e984b04607a7931c48e89c96c7_163)] [added: Information](#i0c69bee1b7c6495895ec2961d1c58cdb_172)] | | | [removed: [71](#iee3984e984b04607a7931c48e89c96c7_163)] [added: [73](#i0c69bee1b7c6495895ec2961d1c58cdb_172)] | | |
| Item 10 | | | [Directors, Executive Officers and Corporate [removed: Governance](#iee3984e984b04607a7931c48e89c96c7_169)] [added: Governance](#i0c69bee1b7c6495895ec2961d1c58cdb_178)] | | | [removed: [71](#iee3984e984b04607a7931c48e89c96c7_169)] [added: [73](#i0c69bee1b7c6495895ec2961d1c58cdb_178)] | | |
| Item 11 | | | [Executive [removed: Compensation](#iee3984e984b04607a7931c48e89c96c7_172)] [added: Compensation](#i0c69bee1b7c6495895ec2961d1c58cdb_181)] | | | [removed: [71](#iee3984e984b04607a7931c48e89c96c7_172)] [added: [73](#i0c69bee1b7c6495895ec2961d1c58cdb_181)] | | |
| Item 12 | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#iee3984e984b04607a7931c48e89c96c7_175)] [added: Matters](#i0c69bee1b7c6495895ec2961d1c58cdb_184)] | | | [removed: [72](#iee3984e984b04607a7931c48e89c96c7_175)] [added: [74](#i0c69bee1b7c6495895ec2961d1c58cdb_184)] | | |
| Item 13 | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#iee3984e984b04607a7931c48e89c96c7_178)] [added: Independence](#i0c69bee1b7c6495895ec2961d1c58cdb_187)] | | | [removed: [72](#iee3984e984b04607a7931c48e89c96c7_178)] [added: [74](#i0c69bee1b7c6495895ec2961d1c58cdb_187)] | | |
| Item 14 | | | [Principal Accounting Fees and [removed: Services](#iee3984e984b04607a7931c48e89c96c7_181)] [added: Services](#i0c69bee1b7c6495895ec2961d1c58cdb_190)] | | | [removed: [72](#iee3984e984b04607a7931c48e89c96c7_181)] [added: [74](#i0c69bee1b7c6495895ec2961d1c58cdb_190)] | | |
| Item 15 | | | [Exhibits, Financial Statement [removed: Schedules](#iee3984e984b04607a7931c48e89c96c7_187)] [added: Schedules](#i0c69bee1b7c6495895ec2961d1c58cdb_196)] | | | [removed: [73](#iee3984e984b04607a7931c48e89c96c7_187)] [added: [75](#i0c69bee1b7c6495895ec2961d1c58cdb_196)] | | |
| Item 16 | | | [Form 10-K [removed: Summary](#iee3984e984b04607a7931c48e89c96c7_190)] [added: Summary](#i0c69bee1b7c6495895ec2961d1c58cdb_199)] | | | [removed: [76](#iee3984e984b04607a7931c48e89c96c7_190)] [added: [78](#i0c69bee1b7c6495895ec2961d1c58cdb_199)] | | |
| [PART I](#i0c69bee1b7c6495895ec2961d1c58cdb_10) | | | | | | | | |
| [PART II](#i0c69bee1b7c6495895ec2961d1c58cdb_175) | | | | | | | | |
| [PART II](#i0c69bee1b7c6495895ec2961d1c58cdb_175)I | | | | | | | | |
| [PART I](#i0c69bee1b7c6495895ec2961d1c58cdb_175)V | | | | | | | | |
| | | | [SIGNATURES](#i0c69bee1b7c6495895ec2961d1c58cdb_202) | | | [79](#i0c69bee1b7c6495895ec2961d1c58cdb_202) | | |
| [PART I](#iee3984e984b04607a7931c48e89c96c7_10) | | | | | | | | |
| [PART II](#iee3984e984b04607a7931c48e89c96c7_166) | | | | | | | | |
| [PART II](#iee3984e984b04607a7931c48e89c96c7_166)I | | | | | | | | |
| [PART I](#iee3984e984b04607a7931c48e89c96c7_166)V | | | | | | | | |
| | | | [SIGNATURES](#iee3984e984b04607a7931c48e89c96c7_193) | | | [77](#iee3984e984b04607a7931c48e89c96c7_193) | | |
Item 2. Properties
1 rewritten, 0 added, 0 removed, 1 unchanged
As of December 31, [removed: 2021,] [added: 2022,] we leased a total of [removed: 17] [added: 22] facilities in [removed: 8] [added: 10] countries consisting of approximately [removed: 320,000] [added: 300,000] square feet of office, research and development, and warehousing space and other related facilities, primarily in North America, Asia and Europe.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
6 rewritten, 3 added, 4 removed, 15 unchanged
As of February [removed: 17, 2022,] [added: 16, 2023,] there were [removed: 8] [added: 7] registered holders of record of our common stock.
The following graph shows the cumulative total return on $100 invested in each of our common stock, the NASDAQ Composite [removed: Index] [added: Index,] and the NASDAQ Health Care Index for the five-year period beginning on December 31, [removed: 2016,] [added: 2017,] and ending on December 31, [removed: 2021,] [added: 2022,] assuming reinvestment of all dividends.
[removed: ][added: ]
| | | | [removed: 2016 | | |] 2017 | | | 2018 | | | 2019 | | | 2020 | | | 2021 | | | [added: 2022 | | |]
| NASDAQ Health Care | | | $ | 100 | | $ | [removed: 121] [added: 96] | | $ | [removed: 116] [added: 121] | | $ | [removed: 146] [added: 157] | | $ | [removed: 190] [added: 151] | | $ | [removed: 183] [added: 120] | |
The material in this performance graph shall not be deemed to be filed with the SEC and is not incorporated by reference in any filing of Insulet Corporation under the Securities Act of 1933, as amended or the Securities Exchange Act of 1934, as amended, whether made on, [removed: before] [added: before,] or after the date of this filing and irrespective of any general incorporation language in such filing.
| Insulet Corporation | | | $ | 100 | | $ | 115 | | $ | 248 | | $ | 370 | | $ | 386 | | $ | 427 | |
| NASDAQ Composite | | | $ | 100 | | $ | 96 | | $ | 130 | | $ | 187 | | $ | 227 | | $ | 152 | |
None.
During the year ended December 31, 2021, we issued securities that were not registered under the Securities Act, which were issued in reliance on the exemption from registration under Section 3(a)(9) of the Securities Act of 1933, as amended (the “Securities Act”).
We issued 2,586,133 shares of our common stock to certain holders of our 1.375% Convertible Senior Notes due 2024 (the “Notes”) upon the conversion of $402.5 million aggregate principal amount of the Notes by such holders.
| Insulet Corporation | | | $ | 100 | | $ | 183 | | $ | 211 | | $ | 454 | | $ | 678 | | $ | 706 | |
| NASDAQ Composite | | | $ | 100 | | $ | 128 | | $ | 123 | | $ | 167 | | $ | 239 | | $ | 291 | |
Item 8. Financial Statements and Supplementary Data
399 rewritten, 235 added, 140 removed, 546 unchanged
Our financial statements as of December 31, [removed: 2021] [added: 2022] and [removed: 2020] [added: 2021] and for each of the three years in the period ended December 31, [removed: 2021,] [added: 2022,] and the Report of the Registered Independent Public Accounting Firm are included in this report as listed in the index.
| [Report of Independent Registered Public Accounting [removed: Firm](#iee3984e984b04607a7931c48e89c96c7_70)] [added: Firm](#i0c69bee1b7c6495895ec2961d1c58cdb_67)] (PCAOB ID Number 248) | | | [removed: [42](#iee3984e984b04607a7931c48e89c96c7_70)] [added: [42](#i0c69bee1b7c6495895ec2961d1c58cdb_67)] | | |
| Consolidated Balance Sheets as of December 31, [removed: 2021] [added: 2022] and [removed: 2020] [added: 2021] | | | [removed: [44](#iee3984e984b04607a7931c48e89c96c7_73)] [added: [44](#i0c69bee1b7c6495895ec2961d1c58cdb_70)] | | |
| Consolidated Statements of [removed: Income] [added: Operations] for the Years ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019] [added: 2020] | | | [removed: [45](#iee3984e984b04607a7931c48e89c96c7_76)] [added: [45](#i0c69bee1b7c6495895ec2961d1c58cdb_73)] | | |
| [Consolidated Statements of Comprehensive [removed: I](#iee3984e984b04607a7931c48e89c96c7_79)ncome] [added: I](#i0c69bee1b7c6495895ec2961d1c58cdb_76)ncome] for the Years ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019] [added: 2020] | | | [removed: [46](#iee3984e984b04607a7931c48e89c96c7_79)] [added: [46](#i0c69bee1b7c6495895ec2961d1c58cdb_76)] | | |
| [Consolidated Statements of Stockholders’ Equity for the Years ended December [removed: 31,](#iee3984e984b04607a7931c48e89c96c7_82) 2021, 2020] [added: 31,](#i0c69bee1b7c6495895ec2961d1c58cdb_79) 2022, 2021] and [removed: 2019] [added: 2020] | | | [removed: [47](#iee3984e984b04607a7931c48e89c96c7_82)] [added: [47](#i0c69bee1b7c6495895ec2961d1c58cdb_79)] | | |
| [Consolidated Statements of Cash Flows for the Years ended December [removed: 31,](#iee3984e984b04607a7931c48e89c96c7_85) 2021, 2020] [added: 31,](#i0c69bee1b7c6495895ec2961d1c58cdb_82) 2022, 2021] and [removed: 2019] [added: 2020] | | | [removed: [48](#iee3984e984b04607a7931c48e89c96c7_85)] [added: [48](#i0c69bee1b7c6495895ec2961d1c58cdb_82)] | | |
| [Notes to Consolidated Financial [removed: Statements](#iee3984e984b04607a7931c48e89c96c7_88)] [added: Statements](#i0c69bee1b7c6495895ec2961d1c58cdb_85)] | | | [removed: [49](#iee3984e984b04607a7931c48e89c96c7_88)] [added: [49](#i0c69bee1b7c6495895ec2961d1c58cdb_85)] | | |
We have audited the accompanying consolidated balance sheets of Insulet Corporation (a Delaware corporation) and subsidiaries (the “Company”) as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] and the related consolidated statements of [removed: income,] [added: operations,] comprehensive income, changes in stockholders’ equity, and cash flows for each of the three years in the period ended December 31, [removed: 2021,] [added: 2022,] and the related notes and financial statement schedule included under Item 15(a) (collectively referred to as the “financial statements”).
We also have audited the Company’s internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] based on criteria established in the 2013 *Internal Control—Integrated Framework* issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”).
In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2021] [added: 2022] in conformity with accounting principles generally accepted in the United States of America.
Also, in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] based on criteria established in the 2013 [removed: Internal Control*—*Integrated Framework] [added: *Internal Control—Integrated Framework*] issued by COSO.
Critical audit [removed: matter][added: matters]
The critical audit [removed: matter] [added: matters] communicated below [removed: is a matter] [added: are matters] arising from the current period audit of the financial statements that [removed: was] [added: were] communicated or required to be communicated to the audit committee and that: (1) [removed: relates] [added: relate] to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit [removed: matter] [added: matters] below, providing separate [removed: opinion] [added: opinions] on the critical audit [removed: matter] [added: matters] or on the accounts or disclosures to which [removed: it relates.][added: they relate.]
*Convertible [removed: Debt Repurchase and Conversion*][added: Debt*]
We identified [removed: this transaction] [added: the rebate estimate] as a critical audit matter.
The principal considerations for our determination that [removed: this matter] [added: the accounting for the resolution of the contract dispute] is a critical audit matter are [removed: the application of] [added: (1) applying] the accounting guidance for [removed: cash paid to note holders] [added: allocating the consideration paid, which is complex] and [added: requires judgement and (2) estimating] the [removed: estimation] [added: allocation] of [added: the] fair value of [removed: the debt component of the notes.][added: those elements.]
Our audit procedures [removed: included, but were not limited to,] [added: related to] the [removed: following:][added: rebate estimate included the following, among others.]
- With the assistance of valuation professionals with specialized skills and knowledge, we tested management’s fair value of the [removed: debt component of the notes.][added: identified intangible assets.]
| (in millions, except share and per share data) | | | [added: 2022 | | | | | |] 2021 | | | | | | 2020 | | |
| Cash and cash equivalents | | | $ | [removed: 791.6] [added: 674.7] | | | | | $ | [removed: 907.2] [added: 791.6] | |
| Accounts [removed: receivable,] [added: receivable trade,] net [removed: (Related Party Transactions Note 5)] [added: — related party] | | | [removed: 161.0] [added: 64.7] | | | | | | [removed: 95.3] [added: 25.8] | | |
| Inventories | | | [removed: 303.2] [added: 346.8] | | | | | | [removed: 154.3] [added: 303.2] | | |
| Prepaid expenses and other current assets | | | [removed: 74.0] [added: 86.9] | | | | | | [removed: 51.5] [added: 74.0] | | |
| Total current assets | | | [removed: 1,329.8] [added: 1,314.0] | | | | | | [removed: 1,248.7] [added: 1,329.8] | | |
| Property, plant and equipment, net | | | [removed: 536.5] [added: 599.9] | | | | | | [removed: 478.7] [added: 536.5] | | |
| Other intangible assets, net | | | [removed: 36.6] [added: 75.5] | | | | | | [removed: 28.7] [added: 36.6] | | |
| Goodwill | | | [removed: 39.8] [added: 51.7] | | | | | | 39.8 | | |
| Other assets | | | [removed: 106.1] [added: 210.0] | | | | | | [removed: 77.0] [added: 106.1] | | |
| Total assets | | | $ | [removed: 2,048.8] [added: 2,251.1] | | | | | $ | [removed: 1,872.9] [added: 2,048.8] | |
| Accounts payable | | | $ | [removed: 37.7] [added: 30.8] | | | | | $ | [removed: 54.1] [added: 37.7] | |
| Accrued expenses and other current liabilities [removed: (Related Party Transactions Note 5)] [added: — related party] | | | [removed: 166.0] [added: 5.4] | | | | | | [removed: 138.1] [added: 1.7] | | |
| Current portion of long-term debt | | | [removed: 25.1] [added: 27.5] | | | | | | [removed: 15.6] [added: 25.1] | | |
| Total current liabilities | | | [removed: 228.8] [added: 364.7] | | | | | | [removed: 207.8] [added: 228.8] | | |
| Long-term debt, net | | | [removed: 1,248.8] [added: 1,374.3] | | | | | | [removed: 1,043.7] [added: 1,248.8] | | |
| Other liabilities | | | [removed: 14.9] [added: 35.7] | | | | | | [removed: 17.8] [added: 14.9] | | |
| Total liabilities | | | [removed: 1,492.5] [added: 1,774.7] | | | | | | [removed: 1,269.3] [added: 1,492.5] | | |
| [removed: Commitment] [added: Commitments] and [removed: Contingencies] [added: contingencies] (Note 17) | | | | | | | | | | | |
| Preferred stock, $.001 par [removed: value:] [added: value, 5,000,000 shares authorized; none issued and outstanding] | | | [added: —] | | | | | | [added: —] | | |
Change in accounting principle
As discussed in Note 2 to the financial statements, the Company changed its method of accounting for convertible debt in 2022 due to the adoption of Accounting Standards Update 2020-06, *Debt – Debt With Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity.*
*Contract Dispute*
As described further in note 17 to the financial statements, the Company entered into an Asset Purchase Agreement as part of the resolution to an ongoing contract dispute.
Pursuant to this agreement the Company made a one-time payment of $25.0 million to the counterparty for the acquisition of developed technology, patents, and the release of future obligations.
This amount was allocated between the intangible assets acquired and the settlement component based on estimated fair values.
We identified the accounting for the resolution of the contract dispute as a critical audit matter.
These considerations heightened the complexity surrounding the design and execution of audit procedures to respond to this risk.
Our audit procedures related to the contract dispute resolution included the following, among others.
- We consulted with our national office resources regarding management’s accounting conclusion that the transaction consisted of multiple elements to be valued and that consideration paid should be allocated using estimated fair values.
This included an assessment of the appropriateness of the methodology, inputs and key assumptions used, particularly the selection of the relief from royalty method to value the intangible assets, prospective financial information, royalty rates, the probability factor related to defending the patent asset and the selection of the discount rate.
*Variable consideration – Rebates to Intermediaries*
As described further in note 2 to the financial statements, the Company provides for certain rebates for sales of its product through intermediaries.
The Company estimates variable consideration related to rebates to pharmacy benefit managers based on historical experience adjusted for revenue growth, market trends and events, individual agreements, product mix and, as available, channel inventory data.
The principal consideration for our determination that the rebate estimate is a critical audit matter is the level of judgement and complexity surrounding the design and execution of audit procedures to respond to this risk due to the subjectivity of the adjustments to historical experience based on recent product variation and volume.
- We tested the design and operating effectiveness of controls related to management’s process to determine rebates, including the completeness and accuracy of the underlying data used in management’s estimation.
- We tested the completeness and accuracy of inputs into the calculation as follows: inspected source documents on a sample basis to test historical rebates, compared revenue growth rates to other audited schedules, and performed sensitivity analyses on the subjective adjustments to historical experience.
- We performed retrospective analysis comparing amounts invoiced to and paid by the Company to previously estimated amounts.
February 23, 2023
| Revenue | | | $ | 1,055.4 | | | | | $ | 1,040.6 | | | | | $ | 904.4 | |
| Revenue from related party | | | 249.9 | | | | | | 58.2 | | | | | | — | | |
| Adoption of ASU 2020-06 (Note 2) | | | — | | | | | | — | | | | | | (207.7) | | | | | | 60.6 | | | | | | — | | | | | | (147.1) | | |
| Balance, December 31, 2022 | | | 69,511 | | | | | | $ | 0.1 | | | | | $ | 1,040.6 | | | | | $ | (584.3) | | | | | $ | 20.0 | | | | | $ | 476.4 | |
| Net income | | | $ | 4.6 | | | | | $ | 16.8 | | | | | $ | 6.8 | |
| Accounts receivable — related party | | | (38.9) | | | | | | (25.8) | | | | | | — | | |
| Accrued expenses and other liabilities — related party | | | 3.7 | | | | | | 1.7 | | | | | | — | | |
| Investments in developed software | | | (12.9) | | | | | | (10.8) | | | | | | (37.5) | | |
| Acquisition of a business | | | (26.0) | | | | | | — | | | | | | — | | |
| Cash paid for investments | | | (7.8) | | | | | | — | | | | | | — | | |
| Cash paid for marketable securities | | | — | | | | | | — | | | | | | (37.9) | | |
| Prepayments of financing lease obligation | | | (15.3) | | | | | | — | | | | | | — | | |
| Supplemental cash flow information (Note 24) | | | | | | | | | | | | | | | | | |
Omnipod 5, which builds on our Omnipod DASH mobile platform, is a tubeless automated insulin delivery system, that integrates with a continuous glucose monitor (“CGM”) to manage blood sugar and is fully controlled by a compatible personal smartphone or Omnipod 5 Controller.
The CGM is sold separately by a third party.
The Company has investments in equity securities of privately held companies in which the Company’s interest is less than 20%, the Company does not exercise significant influence over the investee, and the investment does not have a readily determinable fair value.
These investments are carried at cost less impairment, if any.
If an observable price change in orderly transactions for the identical or similar investment in the same issuer is identified, the investment is measured at its fair value as of the date that the observable transaction occurred with the adjustments reflected in other (expense) income, net in the Company’s consolidated statements of operations.
In 2022, the Company made strategic investments in two companies in the amount of $5.0 million and $2.8 million.
As of December 31, 2022 and December 31, 2021, the total carrying value of the Company’s investments in equity securities without readily determinable fair values was $8.7 million and $0.9 million, respectively.
As of December 31, 2022 and 2021, there were no impairments or adjustments to the Company’s equity investments without readily determinable fair values.
As described further in Note 15 to the consolidated financial statements, the Company repurchased and converted its 1.375% Convertible Senior Notes (“the notes”) due November 2024 for cash and the issuance of common stock.
This resulted in a total loss on extinguishment of $42.4 million.
The guidance for accounting for the inducement as a debt extinguishment is complex.
The Company estimated the fair value of the debt component to determine the loss on extinguishment using a yield model that includes several assumptions, including the discount rate.
- We tested the design and operating effectiveness of controls related to management’s accounting and valuation for the repurchase transaction including management’s evaluation of the qualifications of specialists and review of the work performed by the specialists.
- We consulted with our national office resources regarding management’s accounting conclusion that the repurchase of the notes be accounted for as an extinguishment of debt.
This included an assessment of the appropriateness of the methodology, inputs and key assumptions used.
February 23, 2022
| Short-term investments | | | — | | | | | | 40.4 | | |
| Authorized: 5,000,000 shares at December 31, 2021 and 2020 Issued and outstanding: zero shares at December 31, 2021 and 2020 | | | — | | | | | | — | | |
| Common stock, $.001 par value: | | | | | | | | | | | |
| Revenue (Related Party Transactions Note 5) | | | $ | 1,098.8 | | | | | $ | 904.4 | | | | | $ | 738.2 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Balance, December 31, 2018 | | | 59,189 | | | | | | $ | 0.1 | | | | | $ | 898.5 | | | | | $ | (683.6) | | | | | $ | (2.9) | | | | | $ | 212.1 | |
| Conversion feature of 0.375% Notes, net of issuance costs | | | — | | | | | | — | | | | | | 207.8 | | | | | | — | | | | | | — | | | | | | 207.8 | | |
| Extinguishment of conversion feature on 1.25% Notes, net of issuance costs | | | — | | | | | | — | | | | | | (642.3) | | | | | | — | | | | | | — | | | | | | (642.3) | | |
| Issuance of shares for debt extinguishment | | | 1,875 | | | | | | — | | | | | | 299.4 | | | | | | — | | | | | | — | | | | | | 299.4 | | |
| Purchase of capped call options | | | — | | | | | | — | | | | | | (85.4) | | | | | | — | | | | | | — | | | | | | (85.4) | | |
| Purchases of investments | | | — | | | | | | (37.9) | | | | | | (150.6) | | |
| Purchase of capped call options | | | — | | | | | | — | | | | | | (85.4) | | |
| Proceeds from issuance of common stock, net | | | — | | | | | | 477.5 | | | | | | — | | |
The Omnipod System, which features two discreet, easy-to-use devices, communicates wirelessly, provides for virtually pain-free automated cannula insertion and eliminates the need for multiple daily injections using syringes or insulin pens or the use of pump and tubing.
In addition to selling the Omnipod System for insulin delivery, the Company also partners with global pharmaceutical and biotechnology companies to tailor the Omnipod System technology platform for the delivery of subcutaneous drugs across other therapeutic areas.
Reclassification of Prior Period Amounts
Certain reclassifications have been made to prior period amounts to conform to the current period financial statement presentation.
Unbilled revenues have been combined with accounts receivable, net on the consolidated balance sheet.
The impact of this change was an increase to accounts receivable, net and a decrease to prepaid expenses and other current assets at December 31, 2020.
Unbilled revenue is presented in Note 8.
In addition, the Company reclassified the change in unbilled receivables from the change in prepaid expenses and other current assets to the change in accounts receivable in the prior year statements of cash flows in the amount of $1.9 million and $0.1 million for the years ended December 31, 2020 and 2019, respectively.
There was no change to previously reported total current assets or net cash (used in) provided by operating activities.
bonds that are carried at cost, which approximates their fair value.
Investments in Marketable Securities
Investments may consist of certificates of deposit, commercial paper, U.S. government and agency bonds and corporate bonds.
on the consolidated balance sheet.
| Intellectual property | | | 15 years | | |
Costs to service the claims reflect the current product cost.
At the outset of the contract, the Company assesses the customer’s ability and intention to pay, which is based on a
Effective January 1, 2021, the Company adopted Accounting Standards Update (“ASU”) 2019-12, *Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes.* ASU 2019-12 eliminates certain exceptions in the former guidance regarding the approach for intraperiod tax allocations, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences.
The adoption of this guidance did not have a significant impact on the Company's consolidated financial statements.
An excerpt. Shown here: 40 of 399 rewritten, 40 of 235 added and 40 of 140 removed. The counts are complete. For every sentence, read Item 8. Financial Statements and Supplementary Data in the FY2022 filing and the FY2021 filing.
Item 9A. Controls and Procedures
6 rewritten, 0 added, 0 removed, 10 unchanged
Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, [removed: 2021.][added: 2022.]
Based on the evaluation of our disclosure controls and procedures as of December 31, [removed: 2021,] [added: 2022,] our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at a reasonable assurance level.
There were no changes in our internal control over financial reporting during the three months ended December 31, [removed: 2021] [added: 2022] that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Our management assessed the effectiveness of our internal control over financial reporting as of December 31, [removed: 2021.][added: 2022.]
Based on our assessment, we believe that our internal controls over financial reporting were effective as of December 31, [removed: 2021.][added: 2022.]
The effectiveness of our internal control over financial reporting as of December 31, [removed: 2021] [added: 2022] has been audited by Grant Thornton LLP, an independent registered public accounting firm.
Item 10. Directors, Executive Officers and Corporate Governance
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this Item will be set forth in our definitive proxy statement for our [removed: 2022] [added: 2023] Annual Meeting of Stockholders (the “Proxy Statement”) and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
3 rewritten, 2 added, 2 removed, 10 unchanged
The following table sets forth information regarding securities authorized for issuance under our equity compensation plans as of December 31, [removed: 2021.][added: 2022.]
As of December 31, [removed: 2021, 384,155] [added: 2022, 413,027] restricted stock units were outstanding.
The weighted-average exercise price of outstanding options as of such date issued under these Plans (excluding restricted stock units) was [removed: $81.98.][added: $109.73.]
| Equity compensation plans approved by security holders(1) | | | 695,588 | | | | | | $ | 109.73 | | | | | 2,709,488 | | | (2) | | |
| Total | | | 695,588 | | | | | | 109.73 | | | | | | 2,709,488 | | | | | |
| Equity compensation plans approved by security holders (1) | | | 765,457 | | | | | | $ | 81.98 | | | | | 3,249,369 | | | (2) | | |
| Total | | | 765,457 | | | | | | $ | 81.98 | | | | | 3,249,369 | | | | | |
Item 15. Exhibits, Financial Statement Schedules
46 rewritten, 39 added, 3 removed, 88 unchanged
| 3.2 | | | [added: [Second](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000015/podd-2022x02x24ex31.htm)] [Amended and Restated By-laws of the Registrant (Incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K, filed [removed: February 26, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000081/podd-2016x02x26xexx31.htm)] [added: February](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000015/podd-2022x02x24ex31.htm) [24, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000015/podd-2022x02x24ex31.htm)[](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000015/podd-2022x02x24ex31.htm)] | | |
| 4.2 | | | [Indenture, dated as of [removed: November 10, 2017,] [added: September 6, 2019,] between Insulet Corporation and Wells Fargo Bank, National Association, as Trustee (Incorporated by [removed: r](https://www.sec.gov/Archives/edgar/data/1145197/000119312517340998/d492303dex41.htm)[e](https://www.sec.gov/Archives/edgar/data/1145197/000119312517340998/d492303dex41.htm)[ference] [added: reference] to Exhibit 4.1 to our Current Report on Form [removed: 8-K,] [added: 8-K] filed [removed: on November 13, 2017)](https://www.sec.gov/Archives/edgar/data/1145197/000119312517340998/d492303dex41.htm)] [added: September 9, 2019).](http://www.sec.gov/Archives/edgar/data/1145197/000119312519240972/d766132dex41.htm)] | | |
| [removed: 4.4] [added: 10.31*] | | | [removed: [Indenture, dated as of September 6, 2019,] [added: [Offer Letter] between [removed: Insulet Corporation] [added: Shacey Petrovic] and [removed: Wells Fargo Bank, National Association, as Trustee] [added: Insulet Corporation, dated September 10, 2018] (Incorporated by reference to Exhibit [removed: 4.1] [added: 10.1] to our Current Report on Form 8-K filed September [removed: 9, 2019).](http://www.sec.gov/Archives/edgar/data/1145197/000119312519240972/d766132dex41.htm)] [added: 14, 2018)](http://www.sec.gov/Archives/edgar/data/1145197/000115752318001929/a51865882ex10_1.htm)] | | |
| [removed: 4.5] [added: 4.3] | | | [Form of 0.375% Convertible Notes due 2026 (included in Exhibit 4.1 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2019, filed November 5, 2019)](http://www.sec.gov/Archives/edgar/data/1145197/000119312519240972/d766132dex41.htm) | | |
| [removed: 10.8*] [added: 10.10*] | | | [Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Appendix A to our Definitive Proxy Statement on Schedule 14A filed on April 2, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000119312515117872/d864077ddef14a.htm#toc864077_12) | | |
| [removed: 10.9*] [added: 10.11*] | | | [Form of Executive Officer 3 Year Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.7 to our Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2017, filed May 9, 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000009/podd-exx107_2017331x10q.htm) | | |
| [removed: 10.10*] [added: 10.12*] | | | [Form of International Non-Qualified Stock Option Agreement under the Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2016, filed August 4, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000094/podd-exx101_20160630x10q.htm) | | |
| [removed: 10.11*] [added: 10.13*] | | | [Form of Non-Qualified Stock Option Agreement for Non-Employee Directors under the Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.3 to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2016, filed August 4, 2016](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000094/podd-exx103_20160630x10q.htm)) | | |
| [removed: 10.12*] [added: 10.14*] | | | [Form of Non-Executive Employee Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.60 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed February 29, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1060_20151231x10k.htm) | | |
| [removed: 10.13*] [added: 10.15*] | | | [Form of Section 16 Officer Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.62 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed February 29, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1062_20151231x10k.htm) | | |
| [removed: 10.14*] [added: 10.16*] | | | [Form of Vice President Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.64 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed February 29, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1064_20151231x10k.htm) | | |
| [removed: 10.15*] [added: 10.17*] | | | [Form of Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.4 to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2015, filed August 12, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000059/podd-ex104_20150630x10q.htm) | | |
| [removed: 10.16*] [added: 10.18*] | | | [Form of Incentive Stock Option Agreement under the Second Amended and Restated 2007 Stock Option and Incentive Plan - 2015 Sales Plan (Incorporated by reference to Exhibit 10.51 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2014, filed February 26, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000020/poddex1051_2014311210k.htm) | | |
| [removed: 10.17*] [added: 10.19*] | | | [Form of Non-Qualified Stock Option Agreement for Shacey Petrovic under the Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.53 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2014, filed February 26, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000020/poddex1053_2014123110k.htm) | | |
| [removed: 10.18*] [added: 10.20*] | | | [Form of UK Non-Qualified Stock Option Agreement for Employees at the Vice President Level and Above under the Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.56 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2014, filed February 26, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000020/poddex1056_2014123110k.htm) | | |
| [removed: 10.19*] [added: 10.21*] | | | [Form of Non-Qualified Stock Option Agreement for Company Employees under the Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.4 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2014, filed November 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex104_20140930x10q.htm) | | |
| [removed: 10.20*] [added: 10.22*] | | | [Form of Non-Qualified Stock Option Agreement for Non-Employee Directors under the Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.5 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2014, filed November 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex105_20140930x10q.htm) | | |
| [removed: 10.21*] [added: 10.23*] | | | [Form of Incentive Stock Option Agreement under the Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.7 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2014, filed November 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex107_20140930x10q.htm) | | |
| [removed: 10.22*] [added: 10.24*] | | | [Form of Incentive Stock Option Agreement for Section 16 Officers under the Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.10 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2014, filed November 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex1010_20140930x10q.htm) | | |
| [removed: 10.23*] [added: 10.25*] | | | [Form of Non-Qualified Stock Option Agreement for Section 16 Officers under the Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.11 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2014, filed November 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex1011_20140930x10q.htm) | | |
| [removed: 10.24*] [added: 10.26*] | | | [Form of Incentive Stock Option Agreement under the Second Amended and Restated 2007 Stock Option and Incentive Plan - October 2014 New Hires (Incorporated by reference to Exhibit 10.15 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2014, filed November 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd_ex1015x20140903-10q.htm) | | |
| [removed: 10.25*] [added: 10.27*] | | | [Form of Non-Qualified Stock Option Agreement [removed: for](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000071/podd-ex101_2015128xs8.htm) [Michael] [added: for Michael] Spears (Incorporated by reference to Exhibit 10.1 to our Registration Statement on Form S-8 (No. 333-208387) filed December 8, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000071/podd-ex101_2015128xs8.htm) | | |
| [removed: 10.26*] [added: 10.28*] | | | [Amended and Restated Executive Severance [removed: Plan, effective as of January 1, 2019] [added: Plan] (Incorporated by reference to Exhibit [removed: 10.1] [added: 10.4] to our Current Report on Form 8-K filed [removed: October] [added: February] 22, [removed: 2018)](http://www.sec.gov/Archives/edgar/data/1145197/000115752318002092/a51886773ex10_1.htm)] [added: 2023)](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000011/podd-2023x02x22ex104.htm)] | | |
| [removed: 10.27*] [added: 10.29*] | | | [Insulet Corporation Employee Stock Purchase Plan (Amended and Restated February 27, 2019) (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed May 30, 2019)](http://www.sec.gov/Archives/edgar/data/1145197/000114519719000023/insuletcorporationemployee.htm) | | |
| [removed: 10.29*] [added: 10.32*] | | | [Offer Letter between [removed: Shacey Petrovic] [added: Wayde D. McMillan] and Insulet Corporation, dated [removed: September 10, 2018] [added: January 3, 2019] (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed [removed: September 14, 2018)](http://www.sec.gov/Archives/edgar/data/1145197/000115752318001929/a51865882ex10_1.htm)] [added: on January 7, 2019)](http://www.sec.gov/Archives/edgar/data/1145197/000115752319000039/a51922220ex10_1.htm)] | | |
| [removed: 10.30*] [added: 10.38*] | | | [Offer Letter between [removed: Wayde D. McMillan] [added: John W. Kapples] and Insulet Corporation, dated January [removed: 3,] [added: 22,] 2019 (Incorporated by reference to Exhibit [removed: 10.1] [added: 10.2] to our [removed: Current] [added: Quarterly] Report on Form [removed: 8-K] [added: 10-Q,] filed [removed: on January 7, 2019)](http://www.sec.gov/Archives/edgar/data/1145197/000115752319000039/a51922220ex10_1.htm)] [added: May 3, 2019).](http://www.sec.gov/Archives/edgar/data/1145197/000114519719000020/podd-exx102_20190331x10q.htm)] | | |
| [removed: 10.31+] [added: 10.33+] | | | [removed: [Materials Supplier] [added: [Master Equipment and Services] Agreement between Insulet Corporation and [removed: Flextronics Medical Sales and Marketing, Ltd,] [added: ATS Automated Tooling Systems Inc.,] dated [removed: September 1,] [added: August 31,] 2016 (Incorporated by reference to Exhibit [removed: 10.1] [added: 10.2] to our Quarterly Report on Form 10-Q for the fiscal quarter ended [removed: June] [added: September] 30, 2016, filed November 4, [removed: 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000100/podd-exx101_2016930x10q.htm)] [added: 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000100/podd-exx102_2016930x10q.htm)] | | |
| [removed: 10.32+] [added: 10.36+] | | | [removed: [First Amendment to Materials Supplier Agreement between Insulet Corporation and Flextronics Medical Sales and Marketing, Ltd,] [added: [Amendment No. 16,] entered into [removed: on June 29, 2018 and made] effective as of [removed: January 1, 2018] [added: August 15, 2018, to Supply Agreement, dated November 21, 2013, between Amgen Inc. and Insulet Corporation] (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q for the fiscal quarter ended [removed: June] [added: September] 30, 2018, filed [removed: August 2, 2018)](http://www.sec.gov/Archives/edgar/data/1145197/000114519718000011/podd-exx101_20180630x10q.htm)] [added: November 1, 2018)](http://www.sec.gov/Archives/edgar/data/1145197/000114519718000015/podd-exx101_20180930x10q.htm)] | | |
| [removed: 10.34+] [added: 10.49++] | | | [removed: [Master Equipment and Services] [added: [Amendment No.1 to Development] Agreement [added: by and] between Insulet Corporation and [removed: ATS Automated Tooling Systems Inc.,] [added: DexCom, Inc,] dated [removed: August 31, 2016 (Incorporated] [added: November 21, 2019](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx102_2022x06x30x10q.htm) [(Incorporated] by reference to Exhibit 10.2 to our Quarterly Report on Form 10-Q for the fiscal quarter ended [removed: September] [added: June] 30, [removed: 2016,] [added: 2022,] filed [removed: November 4, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000100/podd-exx102_2016930x10q.htm)] [added: August 5, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx102_2022x06x30x10q.htm)] | | |
| [removed: 10.35] [added: 10.34] | | | [Purchase and Sale Agreement by and between 100 Nagog Park Limited Partnership and Insulet Corporation, dated December 16, 2016 (Incorporated by reference to Exhibit 1.1 to our Current Report on Form 8-K filed December 20, 2016 (Items 1.01 and 9.01)](http://www.sec.gov/Archives/edgar/data/1145197/000115752316007605/a51481585ex1_1.htm) | | |
| [removed: 10.36+] [added: 10.35+] | | | [Supply Agreement, dated November 21, 2013, between Amgen and Insulet Corporation, as amended by Amendment No. 1 through Amendment No. 14 (Incorporated by reference to Exhibit 10.18 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, filed February 28, 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000005/podd-exx1018_20161231x10k.htm) | | |
| [removed: 10.37+] [added: 10.51++] | | | [removed: [Amendment No. 16, entered into effective as of August 15, 2018, to Supply Agreement, dated November 21, 2013, between Amgen Inc.] [added: [Data Agreement by] and [added: between] Insulet Corporation [removed: (Incorporated] [added: and DexCom, Inc, dated May 7, 2020](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx104_2022x06x30x10q.htm) [(Incorporated] by reference to [removed: Exhibit 10.1] [added: Exhibit](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx104_2022x06x30x10q.htm) [](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx104_2022x06x30x10q.htm)[10](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx104_2022x06x30x10q.htm)[.4] to our Quarterly Report on Form 10-Q for the fiscal quarter ended [removed: September] [added: June] 30, [removed: 2018,] [added: 2022](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx104_2022x06x30x10q.htm)[,] filed [removed: November 1, 2018)](http://www.sec.gov/Archives/edgar/data/1145197/000114519718000015/podd-exx101_20180930x10q.htm)] [added: August 5, 20](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx104_2022x06x30x10q.htm)[22)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx104_2022x06x30x10q.htm)] | | |
| [removed: 10.38] [added: 10.37] | | | [Form of Capped Call Transactions Confirmation (Incorporated by reference to Exhibit 10.1 to our Current Report on Form [removed: 8-K](http://www.sec.gov/Archives/edgar/data/1145197/000119312519240972/d766132dex101.htm)[,](http://www.sec.gov/Archives/edgar/data/1145197/000119312519240972/d766132dex101.htm) [filed] [added: 8-K, filed] September 9, 2019).](http://www.sec.gov/Archives/edgar/data/1145197/000119312519240972/d766132dex101.htm) | | |
| [removed: 10.39*] [added: 10.40*] | | | [Offer Letter between [removed: John W. Kapples] [added: James R. Holling](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex101.htm)[s](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex101.htm)[head] and Insulet Corporation, dated [removed: January 22, 2019] [added: May 4, 2022] (Incorporated by reference to Exhibit [removed: 10.2] [added: 10.1] to our [removed: Quarterly] [added: Current] Report on Form [removed: 10-Q](http://www.sec.gov/Archives/edgar/data/1145197/000114519719000020/podd-exx102_20190331x10q.htm)[,](http://www.sec.gov/Archives/edgar/data/1145197/000114519719000020/podd-exx102_20190331x10q.htm) [filed May 3, 2019).](http://www.sec.gov/Archives/edgar/data/1145197/000114519719000020/podd-exx102_20190331x10q.htm)] [added: 8-K, filed May](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex101.htm) [6](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex101.htm)[, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex101.htm)] | | |
| [removed: 10.40*] [added: 10.39*] | | | [Offer Letter between Dan Manea and Insulet Corporation, dated March 19, [removed: 2020](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1056_20201231x10k.htm) [(Incorporated] [added: 2020 (Incorporated] by reference to Exhibit 10.56 to our Annual Report on Form [removed: 10-K](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1056_20201231x10k.htm) [filed] [added: 10-K filed] February [removed: 2](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1056_20201231x10k.htm)[4](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1056_20201231x10k.htm)[, 2021)](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1056_20201231x10k.htm)[.](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1056_20201231x10k.htm)] [added: 24, 2021).](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1056_20201231x10k.htm)] | | |
| [removed: 10.41++] [added: 10.47++] | | | [removed: [Second] [added: [First] Amendment to Materials Supplier Agreement between Insulet Corporation and [removed: Flextronics Medical Sales and Marketing, Ltd, entered into on December 17, 2020 and made effective as of] [added: Sanmina Corporation, dated] October 1, [removed: 2020](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1057_20201231x10k.htm) [(I](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1057_20201231x10k.htm)[n](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1057_20201231x10k.htm)[corporated] [added: 2020.](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1044_20211231x10k.htm) [](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1044_20211231x10k.htm)[(Incorporated] by reference to Exhibit [removed: 10.57 to] [added: 10.4](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1044_20211231x10k.htm)[4](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1044_20211231x10k.htm) [to] our Annual Report on Form [removed: 10-K](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1057_20201231x10k.htm) [filed] [added: 10-K filed] February 24, [removed: 2021)](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1057_20201231x10k.htm)[.](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1057_20201231x10k.htm)] [added: 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1044_20211231x10k.htm)] | | |
| 10.42 | | | [Credit Agreement, dated as of May 4, 2021, by and among Insulet Corporation, the lenders and other parties party thereto and Morgan Stanley Senior Funding, Inc., as administrative agent and collateral agent (Incorporated by reference to Exhibit 10.1 [removed: to the Company's Current] [added: to](https://www.sec.gov/Archives/edgar/data/1145197/000119312521150953/d180998dex101.htm) [our](https://www.sec.gov/Archives/edgar/data/1145197/000119312521150953/d180998dex101.htm) [Current] Report on Form 8-K filed May 5, 2021).](https://www.sec.gov/Archives/edgar/data/1145197/000119312521150953/d180998dex101.htm) | | |
| [removed: 10.43++#] [added: 10.46++] | | | [Materials Supplier Agreement between Insulet Corporation and Sanmina Corporation, dated October 11, 2018.](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1043_20211231x10k.htm) [added: [](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1043_20211231x10k.htm)[(Incorporated by reference to Exhibit 10.43 to our Annual Report on Form 10-K filed February 24, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1043_20211231x10k.htm)] | | |
| [removed: 10.44++#] [added: 10.58++#] | | | [removed: [First Amendment] [added: [Amendment Number 19] to [removed: Materials Supplier] [added: the Supply] Agreement [added: by and] between [removed: Insulet Corporation] [added: Amgen Inc.] and [removed: Sanmina Corporation, dated October 1, 2020](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1044_20211231x10k.htm)[.](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1044_20211231x10k.htm)] [added: Insulet Corporation](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1058_20221231x.htm)[,](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1058_20221231x.htm) [dated](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1058_20221231x.htm) [July](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1058_20221231x.htm) [](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1058_20221231x.htm)[13,](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1058_20221231x.htm) [](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1058_20221231x.htm)[2020](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1058_20221231x.htm)] | | |
| 21.1# | | | [Subsidiaries of the [removed: Registrant](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-exx211_20211231x10k.htm)] [added: Registrant](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd-exx211_20221231x10k.htm)] | | |
| 10.8* | | | [Form of Insulet Corporation 2017 Stock Option and Incentive Plan Non-Qualified Stock Option Agreement (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed February 24, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000015/podd-2022x02x24ex101.htm) | | |
| 10.9* | | | [Form of Insulet Corporation 2017 Stock Option and Incentive Plan Performance Shares Agreement (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed March 1, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000018/podd-2022x03x01ex101.htm) | | |
| 10.30*# | | | [Form of Inventions, Non-Disclosure, Non-Solicitation, Non-Servicing and Non-Competition Agreement (Executive Officers other than Jim Hollingshead and Dan Manea)](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1030_20221231x.htm) | | |
| 10.41* | | | [Retirement and Advisory Agreement between Shacey Petrovic and Insulet Corporation, dated May 4, 2022 (Incorporated by reference to Exhibit 10.2 to our Current Report on Form 8-K, filed May](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex102.htm) [6](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex102.htm)[, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex102.htm) | | |
| 10.43 | | | [Incremental Amendment to Credit Agreement, dated June 15, 2022, among Insulet Corporation, Insulet MA Securities Corporation, Morgan Stanley Senior Funding, Inc., as administrative agent, swingline lender, and letter of credit issuer, and the other lenders party thereto (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed June 1](https://www.sec.gov/Archives/edgar/data/1145197/000119312522174941/d477416dex101.htm)[6](https://www.sec.gov/Archives/edgar/data/1145197/000119312522174941/d477416dex101.htm)[, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000119312522174941/d477416dex101.htm) | | |
| 10.44 | | | [Second Amendment to Credit Agreement, dated November 30, 2022, between Insulet Corporation and Morgan Stanley Senior Funding, Inc., as administrative agent (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed December 1, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000119312522295969/d420238dex101.htm) | | |
| 10.45 | | | [Third Amendment to Credit Agreement, dated November 30, 2022, between Insulet Corporation, Insulet MA Securities Corporation, the lenders and other parties thereto and Morgan Stanley Senior Funding, Inc., as administrative agent (Incorporated by reference to Exhibit 10.2 to our Current Report on Form 8-K, filed December 1, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000119312522295969/d420238dex102.htm) | | |
| 10.48++ | | | [Development Agreement by and between Insulet Corporation and DexCom, Inc, dated December 7, 2016](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx101_2022x06x30x10q.htm) [(Incorporated by reference to Exhibit 10](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx101_2022x06x30x10q.htm)[.1 to our Quarterly R](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx101_2022x06x30x10q.htm)[eport on Form 10-Q for the fiscal quarter ended June 30, 2022, filed August 5, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx101_2022x06x30x10q.htm) | | |
| 10.50++ | | | [Commercialization Agreement by and between Insulet Corporation and DexCom, Inc, dated November 21, 2019](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx103_2022x06x30x10q.htm) [(Incorporated by referen](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx103_2022x06x30x10q.htm)[ce to Exhibit 10.3 to our Q](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx103_2022x06x30x10q.htm)[uarterly Report on Form 10-Q for the fiscal quarter end](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx103_2022x06x30x10q.htm)[ed June 30, 2022](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx103_2022x06x30x10q.htm)[, filed](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx103_2022x06x30x10q.htm) [August 5, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx103_2022x06x30x10q.htm) | | |
| 10.52# | | | [First Amendment to the Master Equipment and Services Agreement originally dated August 31, 2016 between lnsulet Corporation and ATS Automation Tooling Systems Inc., dated 31 August 2021](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1052_20221231x.htm) | | |
| 10.53++# | | | [Second Amendment to the Master Equipment and Services Agreement originally dated August 31, 2016 between lnsulet Corporation and ATS Automation Tooling Systems Inc., dated 31 August 2022](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1053_20221231x.htm) | | |
| 10.54++# | | | [Manufacturing Services and Line Retention Agreement between Insulet Corporation and Flex Medical Sales and Marketing, Ltd., dated July 29, 2022](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1054_20221231x.htm) | | |
| 10.55++# | | | [Amendment Number 15 to the Supply Agreement by and between Amgen Inc. and Insulet Corporation](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1055_20221231x.htm)[,](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1055_20221231x.htm) [dated](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1055_20221231x.htm) [July 12, 2017](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1055_20221231x.htm) | | |
| 10.56++# | | | [Amendment Number 17 to the Supply Agreement by and between Amgen Inc. and Insulet Corporation](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1056_20221231x.htm)[, dated](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1056_20221231x.htm) [April 1, 2019](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1056_20221231x.htm) | | |
| 10.57++# | | | [Amendment Number 18 to the Supply Agreement by and between Amgen Inc. and Insulet Corporation](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1057_20221231x.htm)[,](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1057_20221231x.htm) [dated](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1057_20221231x.htm) [August 1, 2019](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1057_20221231x.htm) | | |
| 10.59++# | | | [Amendment Number 20 to the Supply Agreement by and between Amgen Inc. and Insulet Corporation](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1059_20221231x.htm)[,](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1059_20221231x.htm) [dated](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1059_20221231x.htm) [June](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1059_20221231x.htm) [](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1059_20221231x.htm)[25,](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1059_20221231x.htm) [](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1059_20221231x.htm)[2021](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1059_20221231x.htm) | | |
| 10.60++ | | | [Patent Assignment and License Agreement, dated February 9, 2023, between Insulet Corporation, Bigfoot Biomedical, Inc. and Patients Pending, Ltd. (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed February 14, 2023)](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000004/podd-2023x02x14ex101.htm) | | |
| 10.61* | | | [Form of Insulet Corporation 2017 Stock Option and Incentive Plan Non-Qualified Stock Option Agreement (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed February 22, 2023)](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000011/podd-2023x02x22ex101.htm) | | |
| 10.62* | | | [Form of Insulet Corporation 2017 Stock Option and Incentive Plan Restricted Stock Unit Agreement (Incorporated by reference to Exhibit 10.2 to our Current Report on Form 8-K, filed February 22, 2023)](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000011/podd-2023x02x22ex102.htm) | | |
| 10.63* | | | [Form of Insulet Corporation 2017 Stock Option and Incentive Plan Performance Stock Unit Agreement (Incorporated by reference to Exhibit 10.3 to our Current Report on Form 8-K, filed February 22, 2023)](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000011/podd-2023x02x22ex103.htm) | | |
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| 10.64* | | | [Annual Incentive Compensation Plan (Incorporated by reference to Exhibit 10.5 to our Current Report on Form 8-K, filed February 22, 2023)](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000011/podd-2023x02x22ex105.htm) | | |
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| 10.65* | | | [Consulting Services Agreement by and between the Company and Charles J. Alpuche (Incorporated by reference to Exhibit 10.6 to our Current Report on Form 8-K, filed February 22, 2023)](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000011/podd-2023x02x22ex106.htm) | | |
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| 10.66*# | | | [Form of Confidentiality, Non-Solicit, Non-Compete, and IP Assignment Agreement, by and between the Company and Employee (Jim Hollingshead and Dan Manea)](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1066_20221231x.htm) | | |
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| 4.3 | | | [Form of 1.375% Convertible Senior Notes due 2024 (included in Exhibit 4.2)](https://www.sec.gov/Archives/edgar/data/1145197/000119312517340998/d492303dex41.htm) | | |
| 10.28* | | | [Form of Employee Non-Competition and Non-Solicitation Agreement by and between Insulet Corporation and each of its executive officers (Incorporated by reference to Exhibit 10.17 to Amendment No. 2 to our Registration Statement on Form S-1 (File No. 333-140694), filed April 25, 2007)](http://www.sec.gov/Archives/edgar/data/1145197/000095013507002416/b63591a2exv10w17.txt) | | |
| 10.33+ | | | [Settlement and Cross-License Agreement, dated September 18, 2013, by and among the Company and Medtronic Inc., Medtronic MiniMed Inc., and Medtronic Puerto Rico Operations Co. (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2013, filed November 7, 2013)](http://www.sec.gov/Archives/edgar/data/1145197/000114519713000035/podd-ex101_2013930xq3.htm) | | |
An excerpt. Shown here: 40 of 46 rewritten, all 39 added and all 3 removed. The counts are complete. For every sentence, read Item 15. Exhibits, Financial Statement Schedules in the FY2022 filing and the FY2021 filing.
Item 16. Form 10-K Summary
9 rewritten, 2 added, 3 removed, 44 unchanged
| [removed: February 23, 2022 | | |] /s/ Shacey Petrovic | | | [added: | | | | | |]
| [added: Shacey Petrovic] | | | [removed: Shacey Petrovic] | | | [added: Director | | |]
| February 23, [removed: 2022] [added: 2023] | | | /s/ Wayde McMillan | | |
[removed: We, the undersigned officers and directors of Insulet Corporation, hereby severally constitute and appoint Shacey Petrovic] [added: Hollingshead] and Wayde McMillan, and each of them singly, our true and lawful attorneys, with full power to them and each of them singly, to sign for us in our names in the capacities indicated below, on all amendments to this Report, and generally to do all things in our names and on our behalf in such capacities to enable Insulet Corporation to comply with the provisions of the Securities Exchange Act of 1934, as amended, and all requirements of the Securities and Exchange Commission.
Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant and in the capacities on February 23, [removed: 2022.][added: 2023.]
| /s/ [removed: Shacey Petrovic] [added: James R. Hollingshead] | | | | | | Chief Executive Officer | | |
| [removed: Shacey Petrovic] [added: James R. Hollingshead] | | | | | | (Principal Executive Officer) | | |
| [removed: /s/ James R. Hollingshead] | | | [removed: | | |] [added: James R. Hollingshead] | | |
| [removed: James R. Hollingshead | | |] [added: February 23, 2023] | | | [removed: Director] [added: /s/ James R. Hollingshead] | | |
We, the undersigned officers and directors of Insulet Corporation, hereby severally constitute and appoint James R.
| /s/ Elizabeth Weatherman | | | | | | | | |
| | | | | | | | | |
| /s/ David A. Lemoine | | | | | | | | |
| David A. Lemoine | | | | | | Director | | |