Insulet Corp.

“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.”

“As of December 31, 2025, we had more than 600,000 estimated active Omnipod users globally.”

“In the U.S., we sell our products through the pharmacy channel, which expands access by improving affordable, as no upfront investment is required.”

“The Omnipod platform includes: the Omnipod® 5 Automated Insulin Delivery System (“Omnipod 5”), the Omnipod DASH® Insulin Management System (“Omnipod DASH”), and the Omnipod Insulin Management System (“Classic Omnipod”).”

“Substantially all of our commercialized Drug Delivery revenue consists of sales of a customized version of our product for use in Amgen’s Neulasta Onpro kit under an agreement that expires in December 2028.”

“Omnipod 5 is currently available in 19 countries. Additionally, in August 2024, we received FDA clearance for an expanded indication of Omnipod 5 for people with type 2 diabetes (ages 18 years and older) in the United States.”

“Total revenue increased $636.6 million, or 30.7%, to $2,708.1 million in 2025, compared with $2,071.6 million in 2024.”

“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.”

“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.”

“The Company uses different types of semiconductor chips, which are sourced from external suppliers, in the manufacturing of its products. While the Company has multiple suppliers of semiconductor chips, each type is typically sourced from a single supplier.”

“As of December 31, 2025, we had approximately 5,400 full-time employees, representing a 38% increase over the prior year.”

“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.”

“We estimate that approximately 40% of the type 1 diabetes population in the United States and 25% of the international type 1 diabetes population use insulin pump therapy.”

“If an existing or future competitor develops a product that competes with or is superior to our Omnipod products, we risk losing our position as the perceived technology leader in our field, and our revenue may decline.”

“We are currently working to integrate Omnipod 5 with Abbott’s FreeStyle Libre 3 Plus and developing Omnipod 6, our next generation AID product.”

“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.”

“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”

“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.”

“We have obtained the right to affix the CE Mark under MDR, and UK Conformity Assessed (UKCA marking) to Omnipod 5 and Omnipod DASH, which allows us to distribute these products throughout the European Union and in the United Kingdom.”

“We currently rely on sales of our Omnipod product platform to generate most of our revenue.”

“We expect that sales of our Omnipod products would be limited 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.”