INSULET CORP (PODD)

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and the accompanying notes included in this quarterly report. The following discussion may contain forward-looking statements that reflect our plans, estimates and beliefs, which are subject to risks, uncertainties and assumptions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to these differences include those discussed under the headings “Risk Factors” and “Forward-Looking Statements” in both our Annual Report on Form 10-K for the year ended December 31, 2025 and in this quarterly report. Columns and rows within tables may not add due to rounding. Amounts have been calculated using actual, non-rounded figures; accordingly, amounts and percentages may not recalculate, and columns and rows within tables may not add due to rounding.

Overview

Our mission is to transform the lives of people with diabetes. We are primarily engaged in the development, manufacture, and sale of our proprietary Omnipod product platform, a continuous insulin delivery system for people with insulin-dependent diabetes. The Omnipod platform primarily includes our most recent generation Omnipod 5 and its predecessor Omnipod DASH, which eliminate the need for multiple daily injections using syringes or insulin pens or the use of pump and tubing. Omnipod 5, which builds on our Omnipod DASH mobile platform, is a tubeless automated insulin delivery system that integrates with a continuous glucose monitors (“CGM”) to manage blood sugar and is fully controlled by a compatible personal smartphone or Omnipod 5 Controller. It is indicated for type 1 diabetes and, in the United States, for type 2 diabetes for ages 18 and up. The CGM is sold separately by third parties. The Pod integrates with Dexcom, Inc.’s G6 and G7 CGMs and with Abbott Diabetes Care, Inc.’s (“Abbott”) FreeStyle Libre 2 Plus sensor (“Libre 2 Plus”) in various markets. In June 2026, we expanded compatibility with Abbott’s Freestyle Libre 3 Plus sensor (“Libre 3 Plus”) in the United States and announced the U.S. rollout of Omnipod 5 algorithm enhancements, including a lower 100mg/dL target glucose set point. Omnipod DASH features a secure Bluetooth enabled Pod that is controlled by a smartphone-like Personal Diabetes Manager (“PDM”) with a color touch screen user interface.

Our financial objective is to sustain profitable growth. To achieve this, we continue to roll out Omnipod 5 in additional countries. In February 2026, we launched Omnipod 5 and Omnipod DiscoverTM in five counties in the Middle East, and in July 2026, we launched Omnipod 5 and Omnipod DiscoverTM in Spain. Additionally, we are working on further building our international teams and advancing our regulatory, reimbursement, and market development efforts so we can bring Omnipod 5 to more international markets.

In the U.S., we sell our products through the pharmacy channel, which expands access by improving affordability, as no upfront investment is required. We also continue to increase awareness of Omnipod products through our direct-to-consumer advertising programs.

We are also focused on product development efforts, including choice of smartphone integration and CGM with Omnipod 5 and enhancing the customer experience through digital product and data capabilities. We are currently developing Omnipod 6, our next generation AID product. We also advanced development of our fully closed-loop AID system for people with type 2 diabetes, including enrolling the first participant in our EVOLVE pivotal study to support a planned 510(k) submission in 2027.

Finally, we continue to take steps to strengthen our global manufacturing capabilities, which includes investing in a new manufacturing plant in Costa Rica to support our continued growth.

Results of Operations

Factors Affecting Operating Results

Our Pod is intended to be used continuously for up to three days, after which it may be replaced with a new disposable Pod. The unique patented design of the Omnipod allows us to provide Pod therapy at a relatively low or no up-front investment in regions where reimbursement allows for it and our pay-as-you-go pricing model reduces the risk to third-party payors. As we grow our customer base, we expect to generate an increasing portion of our revenues through recurring sales of our disposable Pods, which provide recurring revenue.

During the six months ended June 30, 2026, we issued two voluntary medical device corrections (“the MDCs”), one in March and the other in May related to separate manufacturing issues that caused a tear in the cannula of certain Omnipod products. During the three and six months ended June 30, 2026, we recorded a net charge associated with the MDCs of $29.3 million and $41.0 million, respectively. We estimate the MDCs and related costs will be in the range of $60 million to $70 million, most of which we expect to incur in 2026, with the remainder expected to be incurred in 2027. The costs to be incurred in 2027 relate to incremental manual quality inspections expected to be performed until automated inspection systems are implemented.

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Revenue

(1) Constant currency revenue growth is a non-GAAP financial measure, which should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. See “Management’s Use of Non-GAAP Measures.”

Total revenue for the three months ended June 30, 2026 increased $152.6 million, or 23.5%, to $801.7 million, compared with $649.1 million for the three months ended June 30, 2025. Total revenue for the six months ended June 30, 2026 increased $345.3 million, or 28.4%, to $1.6 billion, compared with $1.2 billion for the six months ended June 30, 2025. Constant currency revenue growth of 22.7% and 26.2% for the three and six months ended June 30, 2026, respectively, was primarily driven by higher sales volume largely attributable to our growing customer base and, to a lesser extent, higher price.

U.S.

Revenue from the sale of Omnipod products in the U.S. increased $91.0 million, or 20.1%, to $544.1 million for the three months ended June 30, 2026, compared with $453.2 million for the three months ended June 30, 2025. Revenue from the sale of Omnipod products in the U.S. increased $204.8 million, or 24.0%, to $1,059.7 million for the six months ended June 30, 2026, compared with $854.9 million for the six months ended June 30, 2025. The increases for both the three and six months ended June 30, 2026 primarily resulted from higher sales volume driven by growing our customer base.

As discussed in note 1 to our consolidated financial statements, revenue from the sale of Omnipod products in the U.S. included $178.6 million and $327.1 million of sales to a related party for the three and six months ended June 30, 2025, respectively.

For full year 2026, we expect strong U.S. revenue growth primarily driven by the benefits of our recurring revenue model and continued volume growth of Omnipod 5.

International

Revenue from the sale of Omnipod products in our international markets increased $66.0 million, or 35.5%, to $251.8 million for the three months ended June 30, 2026, compared with $185.8 million for the three months ended June 30, 2025. Excluding the 2.7% favorable impact of currency exchange, the remaining 32.9% increase in revenue was primarily due to higher volumes from our growing customer base, and to a lesser extent, a higher average selling price for Omnipod 5, compared with Omnipod DASH.

Revenue from the sale of Omnipod products in our international markets increased $156.5 million, or 46.3%, to $494.6 million for the six months ended June 30, 2026, compared with $338.1 million for the six months ended June 30, 2025. Excluding the 7.9% favorable impact of currency exchange, the remaining 38.4% increase in revenue was primarily due to higher volumes from our growing customer base, and to a lesser extent, a higher average selling price for Omnipod 5, compared with Omnipod DASH.

For full year 2026, we expect higher International Omnipod revenue due to continued volume growth driven by new customers and higher price resulting from conversions to Omnipod 5.

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Drug Delivery

Substantially all of our 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. Drug Delivery revenue was $5.8 million and $10.2 million for the three months ended June 30, 2026 and 2025, respectively, and $9.1 million and $25.1 million for the six months ended June 30, 2026 and 2025, respectively. The $4.4 million and $16.0 million decreases for the three and six months ended June 30, 2026, respectively, were driven by lower order volumes from our partner.

Costs and Expenses

Cost of Revenue

Cost of revenue for the three months ended June 30, 2026 increased $42.3 million, or 21.5%, to $239.1 million, compared with $196.9 million for the three months ended June 30, 2025. Gross margin was 70.2% for the three months ended June 30, 2026, compared with 69.7% for the three months ended June 30, 2025. The 50 basis point increase in gross margin was primarily driven by improved manufacturing efficiencies and, to a lesser extent, increased volumes from our growing customer base. These increases in gross margin were partially offset by higher warranty costs resulting from the voluntary medical device correction issued in May 2026 discussed under “Factors Affecting Operating Results.”

Cost of revenue for the six months ended June 30, 2026 increased $115.0 millio

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Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and the accompanying notes included in this annual report. The following discussion may contain forward-looking statements that reflect our plans, estimates, and beliefs, which are subject to risks, uncertainties, and assumptions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to these differences include those discussed under the headings “Risk Factors” and “Forward-Looking Statements.” Columns and rows within tables may not add due to rounding. Amounts have been calculated using actual, non-rounded figures; accordingly, amounts and percentages may not recalculate, and columns and rows within tables may not add due to rounding.

Overview

Our mission is to transform the lives of people with diabetes. We are primarily engaged in the development, manufacture, and sale of our proprietary Omnipod product platform, a continuous insulin delivery system for people with insulin-dependent diabetes. The Omnipod platform primarily includes our most recent generation Omnipod 5 and its predecessor Omnipod DASH, which eliminate the need for multiple daily injections using syringes or insulin pens or the use of pump and tubing. Omnipod 5, which builds on our Omnipod DASH mobile platform, is a tubeless automated insulin delivery system that integrates with a CGM to manage blood sugar and is fully controlled by a compatible personal smartphone or Omnipod 5 Controller. It is indicated for type 1 diabetes and, in the United States, for type 2 diabetes for ages 18 and up. The CGM is sold separately by third parties. The Pod currently integrates with Dexcom, Inc.’s G6 and G7 CGMs and with Abbott Diabetes Care, Inc.’s (“Abbott”) FreeStyle Libre 2 Plus sensor (“Libre 2 Plus”) in various markets. Omnipod DASH features a secure Bluetooth enabled Pod that is controlled by a smartphone-like PDM with a color touch screen user interface.

Our financial objective is to sustain profitable growth. To achieve this, we launched Omnipod 5 in the United States in 2022, in the United Kingdom and Germany in 2023, and in the Netherlands and France in 2024. In 2025, we launched Omnipod 5 in nine additional countries. We are also working on further building our international teams and advancing our regulatory, reimbursement, and market development efforts so we can bring Omnipod 5 to new international markets.

During 2025, we completed the randomized portion of our RADIANT study in France, the United Kingdom, and Belgium. The RADIANT study is a randomized controlled trial of Omnipod 5 with 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. In the U.S., we sell our products through the pharmacy channel, which expands access by improving affordable, as no upfront investment is required. We also continue to increase awareness of Omnipod products through our direct-to-consumer advertising programs.

In 2025, we also completed STRIVE, our pivotal study for the next generation hybrid closed loop system, and we finished enrollment for EVOLUTION 2, our safety and feasibility study for a fully closed loop AID system for type 2 diabetes. Additionally, we received 510(k) clearance for enhancements to the Omnipod 5 algorithm to include a lower target glucose set point. We also launched our Omnipod 5 app for iPhone compatible with Dexcom’s G7 CGM sensor in the United States and integrated Omnipod 5 with Dexcom’s G7 CGM sensor in five additional countries and with Abbott’s FreeStyle Libre 2 Plus sensor in Australia. Following the launch of Omnipod 5 in several countries in the Middle East in early 2026, Omnipod 5 is now available in 19 countries. We continue to focus on our product development efforts, including choice of smartphone integration and CGM with Omnipod 5 and enhancing the customer experience through digital product and data capabilities. We are currently working to integrate Omnipod 5 with Abbott’s FreeStyle Libre 3 Plus and developing Omnipod 6, our next generation AID product.

Finally, we continue to take steps to strengthen our global manufacturing capabilities. We began producing product at our new manufacturing plant in Malaysia in 2024 and are already investing in another manufacturing plant in Costa Rica to support our continued growth.

Results of Operations

The discussion of our results of operations for 2023 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, 2024 filed with the Securities and Exchange Commission on February 21, 2025.

Factors Affecting Operating Results

Our Pod is intended to be used continuously for up to three days, after which it may be replaced with a new disposable Pod. As of December 31, 2025, we had more than 600,000 estimated active Omnipod users globally. The unique patented design of the Omnipod allows us to provide Pod therapy at a relatively low or no up-front investment in regions where reimbursement allows

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for it and our pay-as-you-go pricing model reduces the risk to third-party payors. As we grow our customer base, we expect to generate an increasing portion of our revenues through recurring sales of our disposable Pods, which provide recurring revenue.

In August 2024, we received FDA clearance for an expanded indication of Omnipod 5 for people with type 2 diabetes. Due to the positive results of our Omnipod 5 type 2 pivotal trial and the learnings from our commercial pilot of Omnipod 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. Accordingly, we decided not to move forward with the commercialization of Omnipod GO. As a result, in 2024, we recorded a charge of $13.5 million related to certain inventory components that would not be utilized.

Comparison of the Years Ended December 31, 2025 and December 31, 2024

Revenue

(1) Constant currency revenue growth is a non-GAAP financial measure which should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. See “Management’s Use of Non-GAAP Measures.”

Total revenue increased $636.6 million, or 30.7%, to $2,708.1 million in 2025, compared with $2,071.6 million in 2024. Constant currency revenue growth of 29.5% was primarily driven by higher sales volume largely attributable to our growing customer base and, to a lesser extent, higher price.

U.S.

Revenue from the sale of Omnipod products in the U.S. increased $410.5 million, or 27.2%, in 2025 to $1,919.8 million, compared with $1,509.3 million in 2024. This increase primarily resulted from higher sales volume driven by growing our customer base. Revenue from the sale of Omnipod products in the U.S. includes $511.6 million of related party revenue in 2025, compared with $587.8 million in 2024. The $76.2 million decrease primarily resulted from one quarter less of related party sales in the current year, partially offset by growth through the pharmacy channel. Additional information regarding our related party transactions is provided in Note 2 to our consolidated financial statements.

In 2026, we expect strong U.S. revenue growth primarily driven by the benefits of our recurring revenue model and continued volume growth of Omnipod 5.

International

Revenue from the sale of Omnipod products in our international markets increased $230.9 million, or 44.1%, in 2025 to $754.3 million, compared with $523.4 million in 2024. Excluding the 4.8% favorable impact of currency exchange, the remaining 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. A higher average selling price for Omnipod 5, compared with Omnipod DASH, also contributed to the revenue increase.

In 2026, we expect higher International revenue due to continued volume growth driven by new customers and higher price resulting from conversions to Omnipod 5.

Drug Delivery

Substantially all of our 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. Drug Delivery revenue was $34.1 million and $38.9 million in 2025 and 2024, respectively.

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Costs and Expenses

Cost of Revenue

Cost of revenue for 2025 increased $142.3 million, or 22.7%, to $768.2 million, compared with $625.9 million in 2024. Gross margin was 71.6% in 2025, compared with 69.8% in 2024. The 180 basis points increase in gross margin was primarily driven by improved manufacturing and supply chain efficiencies, a higher average selling price, increased volume and a $13.5 million charge in the prior year related to certain components utilized in OmnipodGO, which we decided not to commercialize.

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.

Research and Development

Research and development expenses increased $81.5 million, or 37.1%, to $301.1 million for 2025, compared with $219.6 million for 2024. Research and development expenses as a percent of revenue increased to 11.1% in 2025 from 10.6% in 2024. The increase in research and development expense was primarily due to year-over-year headcount additions to support continued investment in our Omnipod and pipeline products, including a fully closed loop AID system for type 2 diabetes, the integration of Libre 3 with Omnipod 5, and Omnipod 6, our next generation AID system. To a lesser extent, the increase was driven by higher consulting costs to support our clinical trials and Omnipod and next generation products.

Selling, General and Administrative

Selling, general and administrative expenses increased $247.8 million, or 27.0%, to $1,165.0 million in 2025, compared with $917.2 million in 2024. This increase was primarily attributable to year-over-year headcount additions to support our business growth, mainly in our commercial and customer experience teams, and incremental advertising expense of $37.1 million. Increased investments in global marketing and training for the sales team to support demand generation also contributed to the increase in se

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