10-K 0001145197-26-000028 (2026-02-18) vs 10-K 0001145197-25-000007 (2025-02-21)
| Section | Compared text | Words now | Changed |
|---|
| Risk Factors | Item 1A | 9,410 |
27.7% |
| MD&A | Item 7 | 5,503 |
44.4% |
| Legal Proceedings | Item 3, via Note 16 – Commitments and Contingencies | 486 |
90.1% |
| Accounting Policies | Item 8, Note 2 – Summary of Significant Accounting Policies | 4,373 |
13.5% |
The redline: what was cut and what was added
In each section, the paragraph that changed most, marked against last year's 10-K:
cut words struck through, new words highlighted and underlined.
Legal Proceedings New paragraph this year (276 words), with no similar paragraph last year.
On April 24, 2025, the United States District Court for the District of Massachusetts entered final judgment in favor of Insulet Corporation in its ongoing litigation against EOFlow Co., Ltd.; EOFlow, Inc.; Nephria Bio, Inc.; and EOFlow’s CEO, Jesse Kim (collectively, “Defendants”), Insulet Corp. v. EOFlow Co. Ltd. et al., 1:23-cv-11780-FDS (D. Mass.). The litigation concerned the Defendants’ misappropriation of Insulet’s proprietary trade secrets relating to the design and manufacture of the Omnipod insulin patch pump. On December 3, 2024, a unanimous jury found four trade secrets asserted by Insulet valid and misappropriated and awarded Insulet total damages of $452 million, composed of $170 million in compensatory damages and $282 million in exemplary damages. The district court’s April 24, 2025 orders upheld the jury verdict and further entered a permanent injunction against Defendants. The injunction prohibits Defendants and others subject to the order from using, possessing, selling, distributing, or seeking regulatory approval for any products that were designed, developed, or manufactured, in whole or in part, using or relying on Insulet’s trade secrets. The injunction is worldwide and took effect immediately subject to a limited exception that permits six months of continuing sales to those patients of EOFlow that existed in the Republic of Korea and the European Union as of October 2023. The permanent injunction further requires EOFlow to assign certain patent applications to Insulet, disgorge any break-up fees received from Medtronic in connection with a previously contemplated acquisition, and submit to ongoing audits to ensure compliance with the district court’s orders. In view of the scope of the permanent injunction, the Court reduced Insulet’s monetary award to $59.4 million to avoid a double recovery.
Source: Item 3, via Note 16 – Commitments and Contingencies, 10-K 0001145197-26-000028 vs Item 3, via Note 18 – Commitments and Contingencies, 10-K 0001145197-25-000007
MD&A 260 words changed in this paragraph; it is 40% similar to last year's version.
We exercise significant judgment generally recognize revenue when control of our products is transferred to customers in an amount that reflects the net consideration we determine variable consideration adjustments. As discussed in Note 2 expect to our consolidated financial statements, we receive. Our products are subject to pricing rebates on pricing programs under arrangements with managed care organizations, such as including pharmacy benefit managers, governmental payors, and third-party commercial payors, primarily in the United States. Reductions These rebates represent amounts owed pursuant to our revenues contractual agreements or legal requirements after the product is dispensed to a benefit plan participant. Provisions for rebates on products sold through our distributors under these rebates, collectively referred to as pharmacy benefits rebates, are treated as variable consideration and are recorded as a reduction to revenue using the most significant component of variable consideration. In addition, pharmacy rebates are most expected value method. Although we record a rebate provision at risk for significant adjustment because of the time delay between of sale, the recording of the provision when revenue is recognized and its ultimate settlement, an interval that related rebate payments are generally ranges from made 30 to 90 days, but can last days thereafter and, in certain cases, may extend up to one year. Our estimates for As a result of this timing difference, revenue recognized in a given period may include adjustments to rebate provisions recorded in prior periods. Estimates of pharmacy rebates are developed based on historical experience, revenue growth, sales trends, levels of inventory in the distribution channel lag, contract amendments channel, and trends. Pharmacy rebates contractual terms. A significant portion of our rebate provisions relate to sales of the Company’s products in the United States. United States pharmacy rebate provisions charged against gross sales amounted to $654.7 million, $452.7 million, and $367.3 million, and $175.2 million in 2025, 2024, and 2023, and 2022, respectively. When To the extent that actual pharmacy rebate settlements payments differ from our estimates, we adjust revise our estimates, which affects reported assumptions and record the resulting adjustments to revenue in the period that in which such variances differences become known.
Source: Item 7, 10-K 0001145197-26-000028 vs Item 7, 10-K 0001145197-25-000007
Risk Factors 217 words changed in this paragraph; it is 55% similar to last year's version.
As we continue to expand the number of customers we serve, driven in large part by significant increasing demand for Omnipod 5, our international expansion and entrance into the insulin-requiring type 2 diabetes market, we expect to continue to increase our manufacturing capacity, our personnel, and the scope of our sales and marketing efforts. This growth, as well as any other Our growth that we may experience in the future, will create challenges for our organization and may strain our management and operations resources, including our customer service. In order to manage future growth, we will be required to improve existing, and implement new, sales and marketing efforts, distribution channels, management, operations, and customer support procedures. In addition, the form and function of our enterprise information technology systems will need to change and be improved upon as our business needs change. For example, we recently implemented a new enterprise resource planning system and plan to upgrade our customer relationship management system. We will also need to manage our supply chain and manufacturing effectively, including our sourcing of materials such as semiconductor chips. We may also need to partner with additional third-party suppliers to manufacture certain components of our Omnipod products and install additional manufacturing lines, including as a part of our newly constructed facility in Malaysia. A transition to new suppliers may result in additional costs or delays. service resources. We may misjudge the amount of time or resources that will be required to effectively manage any anticipated or unanticipated growth in our business, or we may not be able to manufacture sufficient inventory, or and we may not be able to attract, hire, and retain sufficient personnel to meet our expanding needs. If we cannot scale our business appropriately, maintain control over expenses, manufacture our products in a cost-effective or timely manner, or otherwise adapt to anticipated and unanticipated growth, our business resources may become strained, customer experience may decline, and we may not be able to deliver our Omnipod products in a timely manner, and all of which would adversely affect our results of operations may be adversely affected. operations.
Source: Item 1A, 10-K 0001145197-26-000028 vs Item 1A, 10-K 0001145197-25-000007
Accounting Policies 101 words changed in this paragraph; it is 61% similar to last year's version.
The Company’s Drug Delivery product line includes sales of a modified version of the Pod to a pharmaceutical and biotechnology companies company who use the Company’s technology as a delivery method for their drugs. For the majority of this product line, revenue is recognized, with an associated unbilled receivable, as the The product is produced pursuant to the customer’s firm purchase commitments. The commitments, the Company has an enforceable right to payment for performance completed to date date, and the inventory has no alternative use to the Company. The Company recognizes Accordingly, revenue is recognized over time using a blend of percentage-of-completion method, measured based on costs incurred to date relative to total estimated costs at completion and time incurred to date relative to total production time to measure progress toward completion, which results in the satisfaction recognition of its performance obligations. The Company believes that both incurred cost and elapsed time reflect the value generated, which best depicts the transfer of control to the customer. Contract costs include third-party costs as well as an allocation of manufacturing overhead. associated unbilled receivable.
Source: Item 8, Note 2 – Summary of Significant Accounting Policies, 10-K 0001145197-26-000028 vs Item 8, Note 2 – Summary of Significant Accounting Policies, 10-K 0001145197-25-000007
Every change, by type
Sentences and paragraphs of PODD's Risk Factors and MD&A, 10-K 2026-02-18 against 10-K 2025-02-21.
Each links to the text at sec.gov.
Quiet changes are sentences kept from last year with one to four words changed, at least one of them a hedge, a modal or a qualifier
(may, could, will, not, significant, material…). A year or date rolling forward is not counted.
The full word list
adverse, adversely, all, although, anticipate, anticipates, any, approximately, believe, believes, can, cannot, certain, could, expect, expects, generally, however, if, intend, intends, largely, likely, many, material, materially, may, might, most, must, never, no, not, possible, primarily, probable, should, significant, significantly, some, substantial, substantially, unlikely, will, would
AddedRisk Factors
Moreover, compliance with administrative procedures or requirements of third-party payors may result in delays in the payor processing approvals for coverage of Omnipod products. Coverage decisions and rates of reimbursement increasingly require clinical evidence showing an improvement in user outcomes. Generating this clinical evidence requires substantial time and investment and there is no guarantee of a desired outcome.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedRisk Factors
Our failure to compete effectively would negatively impact our revenue and results of operations.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedRisk Factors
The competitive landscape in our industry continues to undergo significant change. We compete with established companies that produce insulin pumps, such as Medtronic Diabetes, a division of Medtronic plc (which division is being spun out into a new, independent publicly traded company), Tandem Diabetes Care Inc., as well as emerging companies like Beta Bionics Inc. Our competitors may develop products in the future that are superior to ours which would inhibit our ability to compete effectively.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedRisk Factors
A significant element of our strategy is to increase revenue growth by continuing to focus on innovation and new product development. The results of our product development efforts may be affected by a number of factors, including our ability to anticipate customer needs, innovate and develop new products and technologies, successfully complete clinical trials, obtain regulatory approvals and reimbursement in the U.S. and abroad, gain and maintain market acceptance of our products, manufacture products in a cost-effective manner, and obtain appropriate intellectual property rights. Further, governmental regulation and laws related to AI and other emerging technologies may increase the burden and cost of research and development or require increased transparency that makes it more difficult to protect our intellectual property. In addition, patents attained by others can preclude or delay our commercialization of a product. There can be no assurance that any products currently in development, or that we may seek to develop in the future, will achieve technological feasibility, obtain regulatory approval, or gain market acceptance. If we are unable to develop and launch new products, our ability to maintain or expand our market position in the markets in which we participate may be negatively impacted. Even if we successfully develop new products, enhancements, or new generations of existing products, they may be quickly rendered obsolete by changing customer preferences, changing industry or regulatory standards, or competitors’ innovations. Our failure to introduce commercially successful new and innovative products in a timely manner could have a material adverse effect on our business, results of operations, financial condition, and cash flows.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedRisk Factors
We may be unable to adequately protect our intellectual property rights, which could limit our ability to sell our products profitably, or at all, and cause us to incur additional costs.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedRisk Factors
•difficulties in obtaining and maintaining reimbursement from foreign healthcare payment systems on a timely basis or at all;
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedRisk Factors
Tariffs, sanctions or other trade barriers imposed by the U.S. (and countermeasures by non-U.S. governments) could adversely impact our supply chain costs or availability of certain components, demand for our products and our business, revenue, financial condition, results of operations and cash flows. Unpredictability of trade policy compounds this risk. Further, the U.S. Department of Commerce Bureau of Industry and Security (“BIS”) has announced the initiation of an investigation into the effects on U.S. national security of imports of personal protective equipment, medical consumables, and medical equipment, including medical devices such as insulin pumps. BIS is conducting the investigation under Section 232 of the Trade Expansion Act of 1962 (Section 232), a law that empowers the president to restrict imports of products that threaten to impair national security. The investigation could result in overriding the tariff exemption currently in place for certain medical devices, which could have a material impact on our results of operations in future years.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedRisk Factors
Our inventory is produced and maintained in a limited number of locations, including one operated by a third party in China, and any loss could have a material adverse effect on our ability to manufacture and sell our products.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedRisk Factors
•our suppliers may be unable to fulfill our orders in a timely manner or at all due to financial hardship or the occurrence of a fire, natural disaster, or other catastrophe; and
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedRisk Factors
Any delays in obtaining approval for our products, or any failure to meet regulatory requirements could adversely affect our ability to sell our products resulting in a negative impact to our financial results.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedRisk Factors
Our promotional materials and training methods must comply with FDA and other applicable laws and regulations, including the prohibition of the promotion of unapproved, or off-label, use. Doctors may prescribe our products off-label, as the FDA does not restrict or regulate a doctor’s choice of treatment within the practice of medicine. However, if the FDA determines that
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedRisk Factors
As Insulet continues to quickly grow, our success is highly dependent on attracting the right talent, retaining our employees, and keeping them engaged and focused on our mission. In 2025, we had changes in key leadership roles, including our Chief Executive Officer and Chief Financial Officer, among others. If we are unable to effectively integrate the new members of the management team, retain other key members of our team, and maintain continuity in critical functions, our business, financial condition, and results of operations could be adversely affected.
Read it in 10-K 2026-02-18 at sec.gov ↗
RemovedRisk Factors
•development of an effective patch pump by one or more competitors or breakthrough diabetes treatments not requiring the delivery of insulin;
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedRisk Factors
•failure of our Omnipod products 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;
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedRisk Factors
•reductions in reimbursement rates or coverage policies relating to Omnipod products by third-party payors;
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedRisk Factors
•claims that any portion of Omnipod products infringes on intellectual property rights of others;
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedRisk Factors
•damage, destruction or loss of any of the facilities where our products are manufactured or stored or of the equipment therein;
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedRisk Factors
•failure to appropriately forecast the demand, competition, and costs related to markets in which we compete; and
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedRisk Factors
•results of clinical studies relating to Omnipod products or our competitors’ products.
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedRisk Factors
If any of these events occur, our ability to generate revenue could be significantly reduced, which would adversely affect our business, financial condition, and results of operations.
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedRisk Factors
reduced market acceptance and sales of our products, which would adversely affect our business, financial condition, and results of operations.
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedRisk Factors
In addition, some of our competitors, such as Medtronic, are large, well-capitalized companies with more resources than we have. These companies may have competitive advantages over us, including:
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedRisk Factors
•established relations with healthcare professionals, customers, and third-party payors;
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedRisk Factors
•greater experience in conducting research and development, clinical trials, manufacturing, marketing, and obtaining regulatory approval; and
Read it in 10-K 2025-02-21 at sec.gov ↗
RewordedRisk Factors
If our or our contract manufacturers’ facilities fails a quality system inspection or otherwise fails to adhere to QSR requirements, this could delay production of our products and lead to business disruption; failure to take adequate and timely corrective action in response to an adverse quality system inspection or QSR violation could result in business disruption; In addition, failure to take adequate and timely corrective action in response to an adverse quality system inspection or QSR violation could result in fines, difficulties in obtaining regulatory clearances, recalls, enforcement actions, including injunctive relief or consent decrees, or other consequences, which could have a material adverse effect on our customers’ experience and our financial condition or results of operations.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedRisk Factors
If our intermediaries are unwilling or unable to market and sell our products, do not devote adequate resources or support to generate awareness of our products and grow product sales, or if they or our sales force do not perform to our expectations, we could experience delayed or reduced market acceptance and sales of our products, which would adversely affect our business, revenue, financial condition, and results of operations.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedRisk Factors
Uncertainty about global economic conditions, particularly in countries with government-sponsored healthcare systems, may also cause slower adoption of new technologies such as Omnipod 5, resulting in decreased demand for our products and increased competition, downward pricing pressure, and increased user attrition, which could have a material adverse effect on our business, sales, financial condition, and results of operations. 5.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedRisk Factors
Uncertainty about global Our failure to effectively navigate these geopolitical and economic conditions, particularly in countries with government-sponsored healthcare systems, challenges may also cause slower adoption of new technologies such as Omnipod 5, resulting result in decreased demand for our products and increased competition, downward pricing pressure, and increased user attrition, which could have a material adverse effect on our business, sales, revenue, financial condition, and results of operations.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedRisk Factors
While we anticipate entering into additional contracts with other intermediaries and third-party payors, we cannot assure be sure that our efforts will be successful, which could limit successful or that we will be able to maintain these contracts as they can generally be terminated by the availability of Omnipod products. third-party payor without cause.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedRisk Factors
We expect that sales of our Omnipod products, which, for Omnipod 5, occur only through the pharmacy channel in the United States and for Omnipod DASH, primarily through the pharmacy channel, will products would be limited unless if a substantial portion of their sales price is not paid for by third-party payors, including private insurance companies, health maintenance organizations, preferred provider organizations, federal and state government healthcare agencies, intermediaries, Medicare, Medicaid, and other managed care providers.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedRisk Factors
If we cannot scale our business appropriately, maintain control over expenses, manufacture our products in a cost-effective or timely manner, or otherwise adapt to anticipated and unanticipated growth, our business resources may become strained, customer experience may decline, and we may not be able to deliver our Omnipod products in a timely manner, and all of which would adversely affect our results of operations may be adversely affected. operations.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedRisk Factors
This growth, as well as any other Our growth that we may experience in the future, will create challenges for our organization and may strain our management management, operations, and operations resources, including our customer service. service resources.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedRisk Factors
However, the ever-evolving threats mean we must continually evaluate and adapt our systems and processes, and our efforts may not be adequate to safeguard against all data security breaches, misuse of data, or sabotage of our systems. processes.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedRisk Factors
Accordingly, our ability to continue to generate revenue is highly reliant on our ability to successfully market and sell our Omnipod products to new and to retain consumers who currently use existing customers, which could be negatively impacted by the product. risks described throughout these Risk Factors.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedRisk Factors
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 condition, and results of operations. clinicians or reimbursement from third-party payors.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedRisk Factors
The occurrence international nature of any of these events our business subjects us to additional business risks that may have a material an adverse effect on our business, financial condition, and condition or results of operations.
Read it in 10-K 2026-02-18 at sec.gov ↗
Quiet changesRisk Factors
We currently rely on sales of our Omnipod product platform to generate nearly all most of our revenue.
Read it in 10-K 2026-02-18 at sec.gov ↗
Quiet changesRisk Factors
The failure to retain a high percentage of our customers could would negatively impact our revenue growth and may have a material adverse effect on our business, financial condition, and results of operations.
Read it in 10-K 2026-02-18 at sec.gov ↗
Quiet changesRisk Factors
We are subject to extensive government regulation, which could restrict the sales and marketing of our products, could cause us to incur significant costs, and impact our profitability and competitiveness.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedMD&A
While we do not expect tariffs to have a significant impact on our gross margin in 2026, should the exemption that is currently in place for certain medical devices be eliminated, tariffs would have a material impact on our results of operations in future years.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedMD&A
In 2026, we expect net interest expense to increase to $40 million or more, primarily due to lower interest income.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedMD&A
During 2025, we repurchased $419.9 million million in principal ($417.6 million net of issuance costs) of our Convertible Senior Notes for $541.5 million in cash, which resulted in a $123.9 million loss on extinguishment. Refer to Note 13 to our consolidated financial statements for additional information.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedMD&A
on extinguishment of our Convertible Senior Notes during 2025, the settlement of which resulted in non-deductible premiums, These impacts were partially offset by a nontaxable gain on the related derivative asset.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedMD&A
The Organization for Economic Co-operation and Development (“OECD”) and participating countries continue to advance the implementation of a 15% global minimum corporate tax (“Pillar Two”). More than 50 countries, including the Netherlands and the United Kingdom, in which we operate, have enacted elements of the global minimum tax legislation with certain provisions effective in 2025. In January 2026, the OECD issued additional administrative guidance introducing a “side-by-side” framework applicable to U.S.-parented multinational groups. This framework provides an exemption from the application of certain Pillar Two charging provisions, including the Income Inclusion Rule and the Undertaxed Profits Rule, while such groups remain subject to Qualified Domestic Minimum Top-Up Taxes enacted by individual jurisdictions. We anticipate additional legislative activity and administrative guidance related to Pillar Two throughout 2026. Based on the legislation enacted as of December 31, 2025, the implementation of Pillar Two did not have a material impact on our consolidated financial statements for 2025. We are continuing to evaluate the potential impact on future periods.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedMD&A
In July 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the United States. The OBBBA permanently extends certain provisions of the Tax Cuts and Jobs Act, modifies aspects of the international tax framework, and restores favorable tax treatment for certain business provisions, including the immediate expensing of domestic research and development expenditures. The OBBBA also provides accelerated tax deductions for certain qualified property. The legislation has multiple effective dates, with certain provisions effective in 2025 and others effective through 2027. In 2025, OBBBA resulted in a decrease in our deferred tax assets of approximately $70 million, primarily due to the immediate expensing of domestic research and development expenditures and a corresponding increase in both operating and free cash flow. The impact on our consolidated statement of income was insignificant. We continue to evaluate the optional tax elections available under OBBBA and their potential impact on our consolidated financial statements for 2026 and subsequent periods.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedMD&A
(1) 2025 includes $11.7 million reversal of stock-based compensation expense associated with the departure of the Company’s former Chief Executive Officer and Chief Financial Officer.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedMD&A
(2) Represents severance benefits for the Company’s former Chief Executive Officer and Chief Financial Officer.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedMD&A
(4) Represents the change in fair value of the derivative asset associated with the redemption of Convertible Senior Notes.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedMD&A
Our $450 million aggregate principal amount of 6.5% senior unsecured notes, due 2033, contain leverage and fixed charge coverage ratio covenants, both of which are measured upon the incurrence of future debt, as well as other customary covenants, none of which we consider restrictive to our operations.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedMD&A
In March 2025, the Company’s Board of Directors authorized a program to repurchase up to $125.0 million of common stock through December 31, 2026 to offset dilution from stock-based compensation. During 2025, we repurchased approximately 184 thousand shares for $59.6 million under this program. In February 2026, the Board of Directors extended the authorization of this program through December 31, 2027 and approved an additional $350 million in repurchases of common stock. We plan to utilize $300 million of existing cash to repurchase shares in the first quarter of 2026.
Read it in 10-K 2026-02-18 at sec.gov ↗
AddedMD&A
Repurchase of Common Stock—During 2025, we paid $59.6 million to repurchase common shares to offset dilution from stock-based compensation.
Read it in 10-K 2026-02-18 at sec.gov ↗
RemovedMD&A
In 2022, we issued two voluntary Medical Device Correction (“MDC”) notices, one for our Omnipod DASH PDM related to its battery and the other for our Omnipod 5 Controller related to its charging port and cable. During 2022, we initially recorded a net charge of $57.9 million related to these MDCs and, in 2023, we recorded $11.5 million of income associated with a change in our estimated liability for the MDCs, primarily due to lower distribution costs.
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedMD&A
Revenue from the sale of Omnipod products in the U.S. increased $258.3 million, or 20.6%, in 2024 to $1,509.3 million, compared with $1,251.0 million in 2023. This increase primarily resulted from higher volume through the pharmacy channel driven by growing our customer base, partially offset by a decrease in estimated inventory days-on-hand at distributors and lower conversions to Omnipod 5. Inventory days-on-hand declined to more normal levels following an acceleration of orders by U.S. pharmacy wholesales in advance of the implementation of our new ERP system on January 1, 2024. We experienced a benefit from conversions to Omnipod 5 in the prior year following the launch of the product in the latter half of 2022 since users generally fill both their Omnipod 5 starter kit and their first month of refills simultaneously. Conversions to Omnipod 5 declined since the vast majority of U.S. conversions to Omnipod 5 occurred in 2023. To a lesser extent, the revenue increase was driven by a higher average selling price resulting from our annual wholesale acquisition cost increase implemented during the second quarter of 2024 and growth in the pharmacy channel.
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedMD&A
Omnipod 5. A higher average selling price for Omnipod 5 compared with Omnipod DASH and Classic Omnipod also contributed to the revenue increase, although to a lesser extent.
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedMD&A
We expect gross margin to further increase to approximately 70.5% in 2025 primarily due to improved manufacturing efficiencies.
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedMD&A
We expect selling, general and administrative expenses to increase in 2025 compared with 2024 due to investments in our operating structure, primarily headcount additions, particularly in the areas of customer support, sales and information technology support, to facilitate continued growth globally. We also plan to make additional investments to support the Omnipod platform and to continue support the phased launch of Omnipod 5 in our existing international markets and prepare for expansion into new countries.
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedMD&A
In 2021, the Organization for Economic Co-operation and Development (“OECD”) and G20 international forum released the Model Global Anti-Base Erosion (GloBE) rules (“Model Rules”) under Pillar Two. These Model Rules set forth the common approach for a Global Minimum Tax at 15% for multinational enterprises with revenue greater than €750 million and is expected to be applicable to Insulet. Pillar Two has been adopted by the Council of the European Union for implementation by European Union member states by December 31, 2023, with effect for tax years beginning 2024. Similar directives under Pillar Two are already adopted or expected to be adopted by taxing authorities in other countries where Insulet has business operations, with widespread implementation of the Global Minimum Tax in 2024 and 2025. There was no impact on the consolidated financial statements for 2024. While we do not expect the Pillar Two Model Rules and related legislation to have a material impact on our consolidated financial statements for 2025, we continue to evaluate their potential impact on future years.
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedMD&A
(1) Represents net (income) expense resulting from estimated costs associated with the voluntary MDC notices issued in the fourth quarter of 2022 and adjustments to those costs, which is included in cost of revenue. Refer to Note 13 to our consolidated financial statements for additional information.
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedMD&A
(2) Represents non-operating gain or loss related to fair value adjustments of strategic debt and other investments.
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedMD&A
To finance our operations and global expansion, we have periodically issued convertible senior notes, which are convertible into our common stock. As of December 31, 2024, the following Convertible Senior Notes were outstanding:
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedMD&A
Issuance Date Coupon Principal Outstanding Due Date Conversion Rate(1) Conversion Price (in millions) per Share of Common Stock September 2019 0.375% $800.0 September 2026 4.4105 $226.73
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedMD&A
In connection with the issuance of the Convertible Senior Notes, we purchased capped call options (“Capped Calls”) on our common stock. By entering into the Capped Calls, we expect 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) if at the time of conversion our stock price exceeds the conversion price under the Convertible Senior Notes. The Capped Calls have an initial strike price of $335.90 per share and cover 3.5 million shares of our common stock.
Read it in 10-K 2025-02-21 at sec.gov ↗
RemovedMD&A
Acquisitions—In 2023, we paid Bigfoot Biomedical, Inc. $25.1 million, including transaction costs, to acquire patent assets related to pump-based AID technologies. We also paid a purchase price holdback of $3.0 million associated with our 2022 acquisition of substantially all the assets related to the manufacture and production of shape-memory alloy wire assemblies used in the production of our product from Dynalloy, Inc.
Read it in 10-K 2025-02-21 at sec.gov ↗
RewordedMD&A
Years Ended December 31, (in millions) 2025 2024 2023 Net income $ 247.1 $ 418.3 $ 206.3 Interest expense, net 24.7 3.2 7.6 Income tax expense (benefit) 92.4 (118.1) 8.3 Depreciation and amortization 90.4 80.8 72.8 Stock-based compensation expense compensation(1) 62.7 69.3 48.3 Voluntary medical device corrections(1) CEO and CFO transition(2) 9.3 — (11.5) Unrealized loss (gain) Loss on investments(2) extinguishment of debt(3) 123.9 — Gain on derivative asset(4) (12.5) — Loss on investments(5) 7.5 3.8 (2.6) Adjusted EBITDA $ 457.3 645.5 $ 329.2 457.2
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedMD&A
Excluding the 0.7% 4.8% favorable impact of currency exchange, the remaining 26.9% 39.3% increase in revenue was primarily due to higher volumes from our growing customer base, largely resulting from the prior year launches of Omnipod 5 in the United Kingdom and Germany in the prior year, driven by our growing customer base and the favorable impact of conversions to 5.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedMD&A
Finally, the The increase in accrued expenses and other liabilities was primarily driven by an increase in accrued compensation costs due to driven by higher incentive compensation achievement and headcount additions to support our growing business, and an increase in professional consulting fees primarily driven by accrued rebates due to higher legal costs and direct-to-consumer spending. sales volume.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedMD&A
Due to the positive results of our Omnipod 5 type 2 pivotal trial and the learnings from our commercial pilot of Omnipod GO commercial pilot, GO, a basal-only Pod for certain individuals with type 2 diabetes, we made a strategic decision to drive growth in the type 2 diabetes market with Omnipod 5 and, accordingly, decided not to move forward with the commercialization of Omnipod GO. 5.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedMD&A
Similar to the The RADIANT study is a randomized control controlled trial that we completed in the United States and France for of Omnipod 5 with DexCom’s G6 CGM, the objective is Libre 2, designed to provide clinical data to support our pricing and market access initiatives as we roll out Omnipod 5 with multiple sensors across our international markets.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedMD&A
The working capital outflow was driven by a $32.4 $140.2 million increase in inventories, a $21.9 accounts receivable and an $81.7 million increase in prepaid expenses and other assets, and a $10.4 million increase in accounts receivable, partially offset by a $45.5 $160.2 million increase in accrued expenses and other liabilities. liabilities and a $49.2 million increase in accounts payable.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedMD&A
When To the extent that actual pharmacy rebate settlements payments differ from our estimates, we adjust revise our estimates, which affects reported assumptions and record the resulting adjustments to revenue in the period that in which such variances differences become known.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedMD&A
This increase was primarily attributable to year-over-year headcount additions to support our business growth, international expansion mainly in our commercial and sustain Omnipod 5, customer experience teams, and as a result incremental advertising expense of our new organizational structure. $37.1 million.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedMD&A
Interest income increased $10.9 decreased $4.9 million to $34.7 million in 2025, compared with $39.5 million in 2024, compared with $28.6 million in 2023 2024 primarily driven by increased average cash balances and higher lower interest rates.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedMD&A
As discussed in Note 2 to our consolidated financial statements, we Our products are subject to pricing rebates on pricing programs under arrangements with managed care organizations, such as including pharmacy benefit managers, governmental payors, and third-party commercial payors, primarily in the United States.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedMD&A
Our estimates for Estimates of pharmacy rebates are developed based on historical experience, revenue growth, sales trends, levels of inventory in the distribution channel lag, contract amendments channel, and trends. contractual terms.
Read it in 10-K 2026-02-18 at sec.gov ↗
RewordedMD&A
During 2024, 2025, we completed participant enrollment in the randomized portion of our RADIANT study in France, the United Kingdom, and Belgium, which is our Omnipod 5 with Libre 2 randomized controlled trial. Belgium.
Read it in 10-K 2026-02-18 at sec.gov ↗
Quiet changesMD&A
Words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “would,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” “potential,” “risk,” or “continue” or the negative of these terms or other similar words or expressions are intended to identify these forward-looking statements.
Read it in 10-K 2026-02-18 at sec.gov ↗
