PODDInsulet Corporation
Insulet Corporation (“we” or the “Company”) is primarily engaged in the development, manufacture, and sale of its proprietary continuous insulin delivery systems for people with insulin-dependent diabetes. 10-K, Item 1
- Employees
- 5,400
- Headquarters
- Acton, MA
- CEO
- Ashley McEvoy
- Next results
- around Feb 17, 2027
13 paragraphs in Risk Factors of the 10-K filed Feb 18, 2026 with nothing like them in the 10-K filed Feb 21, 2025. Quoted exactly. Paragraphs that were only edited are under 10-K change.
Compared with the Risk Factors in the latest 10-K of the other 59 Health care companies: a paragraph with at least half its words the same at another company is called similar, and the companies are listed under it. A paragraph most of them have is marked boilerplate. No line means no other company has one like it. This counts text; it does not say how serious a risk is.
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.
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Our failure to compete effectively would negatively impact our revenue and results of operations.
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.
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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.
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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.
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•difficulties in obtaining and maintaining reimbursement from foreign healthcare payment systems on a timely basis or at all;
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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.
Similar paragraph at 1 of 59 other Health care companies: BDXRead in the 10-K ↗
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.
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•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
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4 more
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.
Similar paragraph at 1 of 59 other Health care companies: COORead in the 10-K ↗
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
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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.
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If we are presented with appropriate opportunities, we may pursue acquisitions or investments in complementary businesses, products, or technologies. If we do so, we may not complete transactions in a timely manner, on a cost-effective basis, or at all,
Similar paragraph at 1 of 59 other Health care companies: VRTXRead in the 10-K ↗
New in the latest 10-Q
22 paragraphs in the 10-Q filed Nov 4, 2026 with nothing like them in the 10-Q filed Aug 5, 2026 (at least half the words must differ; new numbers alone do not count). Quoted exactly, grouped by the item heading above them. This is text that changed, not a judgement of how serious it is.
Financial statements and notes
There were no changes to the carrying amount of goodwill during the nine months ended September 30, 2026.
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In September 2026, the Company amended its senior secured credit agreement, refinancing the $ 475 million outstanding principal balance of its Term Loan B and reducing the applicable interest rate from Secured Overnight Financing Rate (“SOFR”) plus 2.00 % to SOFR plus 1.75 %. The refinancing was accounted for as a combination of debt modifications, extinguishments, and new debt issuances and resulted in a $ 0.3 million loss on extinguishment of debt related to the write-off of unamortized debt discount and issuance costs. In addition, borrowings under the Revolving Credit Facility now bear interest at a rate of SOFR plus an applicable margin of 1.25 % to 1.75 % based on the Company’s total leverage ratio, and the borrowing capacity under the Revolving Credit Facility was increased to $ 750 million.
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(1) Fair value was determined using quoted market prices and estimated current rates offered for similar debt under current market conditions. During the three months ended September 30, 2026, the Company began classifying these financial instruments as Level 2 because their fair values were determined using observable market inputs other than quoted prices in active markets for identical instruments.
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In October 2026, the Board of Directors authorized a $1 billion common stock repurchase program, effective through December 31, 2028.
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Other expense, net was $0.2 million and $0.7 million for the three and nine months ended September 30, 2026, respectively. Other income, net was $12.1 million and $11.2 million for the three and nine months ended September 30, 2025, respectively. Other income, net for both the three and nine months ended September 30, 2025 included a $12.5 million gain resulting from the change in fair value of the derivative asset associated with the redemption of our Convertible Senior Notes.
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(5) Amounts for the three and nine months ended September 30, 2026 relate to the refinancing of our Term Loan B. The amount for the nine months ended September 30, 2025 relates to the repurchase of Convertible Senior Notes.
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(6) Represents the change in fair value of the derivative asset associated with the redemption of our Convertible Senior Notes.
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Investments in Developed Software - Investments in developed software were $13.1 million and $13.5 million for the nine months ended September 30, 2026 and 2025, respectively, and were primarily related to projects supporting our cloud-based capabilities.
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In October 2026, the Board of Directors authorized a $1 billion common stock repurchase program, effective through December 31, 2028. We expect to allocate approximately $400 million toward repurchases in 2026, funded with existing cash.
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Item 6
101 The following materials from Insulet Corporation’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2026 formatted in iXBRL (Inline eXtensible Business Reporting Language), as follows:
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(i) Condensed Consolidated Balance Sheets (Unaudited) as of September 30, 2026 and December 31, 2025
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(ii) Condensed Consolidated Statements of Income (Unaudited) for the three and nine months ended September 30, 2026 and 2025
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(iii) Condensed Consolidated Statements of Comprehensive Income (Unaudited) for the three and nine months ended September 30, 2026 and 2025
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(iv) Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) for the three and nine months ended September 30, 2026 and 2025
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(v) Condensed Consolidated Statements of Cash Flows (Unaudited) for the nine months ended September 30, 2026 and 2025
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10.1*+ Amendment No. 9, dated as of August 25, 2026, to the Amended and Restated Development and Commercialization Agreement by and between Insulet Corporation and Abbott Diabetes Care Inc. dated as of September 13, 2021.
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10.2# Insulet Nonqualified Deferred Compensation Plan (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed September 16, 2026).
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10.3 Ninth Amendment to Credit Agreement, dated September 21, 2026, among Insulet Corporation, Insulet MA Securities Corporation, Morgan Stanley Senior Funding, Inc., as administrative agent, and the other lenders party thereto (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed September 21, 2026).
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31.1* Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 by Chief Executive Officer.
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31.2* Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 by Chief Financial Officer.
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32.1** Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, by Chief Executive Officer and Chief Financial Officer.
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+ Certain portions of this exhibit are considered confidential and have been omitted as permitted under SEC rules and regulations.
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The 10-Q's risk factors against the 10-K
Item 1A of the 10-Q filed Nov 4, 2026 against Item 1A of the 10-K filed Feb 18, 2026.
A 10-Q repeats only the risks that changed, so a 10-K paragraph that is missing from it is not counted as removed.
Added is a paragraph with nothing like it in the 10-K, Reworded a sentence that is in both with several words changed,
Quiet changes a sentence in both where one to four words changed and one is a hedge or a modal
(cut words struck through, new words highlighted and underlined).
Text on the page, not a score; each links to the filing at sec.gov.
What the 10-Q itself says about its risk factors:
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See “Risks Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 for a discussion of risks to which our business, financial condition, results of operations, and cash flows are subject. There have been no material changes to the risk factors disclosed in that Annual Report.
1 paragraph in the 10-Q's Item 1A, and none of them adds, rewords or quietly edits a paragraph of the 10-K's.
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