MiniMed Group, Inc.

MiniMed Group, Inc. operates in the global diabetes medical technology industry, developing, manufacturing, and marketing a comprehensive suite of solutions for the management of diabetes. The company estimates the current market for its diabetes technologies and other offerings to be over $19 billion ¹, based on the twelve months ended February 2026 revenue from public filings of leading diabetes device manufacturers as identified by Seagrove Partners. The market is expected to grow at a compound annual growth rate above 10% from 2026 through at least 2030 ², according to Seagrove Partners’ March 2026 market model, driven by the adoption of advanced diabetes management technologies which are currently underpenetrated. The company serves people with diabetes who require intensive insulin therapy, representing all people with Type 1 diabetes and a subset of those with Type 2 diabetes.

The company competes with companies such as Beta Bionics, Inc.; Dexcom, Inc.; Insulet Corporation; Sequel Med Tech, LLC; and Tandem Diabetes Care, Inc. ³. MiniMed believes its integrated approach, commercializing all parts of an integrated diabetes management system, is a significant advantage over competitors who specialize in component or subsystem solutions and must establish strategic partnerships to offer Smart Dosing solutions. According to Seagrove Partners’ March 2026 GlobeVIEW Scoreboard, MiniMed is a global leader in insulin pumps by users ⁴, servicing pump users in over 80 countries ⁵ as of April 2026. The MiniMed 780G has maintained the number one pump satisfaction in the United States since Q2 2024 ⁶, according to pump satisfaction survey results from dQ&A’s Q4 2025 U.S. Diabetes Patient Voice report.

The company generates revenue through the sale of insulin delivery devices (primarily insulin pumps and pens), continuous glucose monitors, other consumables, supplies, and related software and services. In fiscal year 2026 and fiscal year 2025, 82% ⁷ and 80% ⁸ of total revenue, respectively, came from sales of CGMs, other consumables, software, and services, which the company believes makes its core revenue base durable and resilient. The company utilizes a dual-channel approach in the United States, distributing the majority of products through the DME channel and a small percentage through the pharmacy channel. Outside the United States, revenue represented approximately 70% ⁹ and 67% ¹⁰ of total revenue in fiscal year 2026 and fiscal year 2025, respectively.

The company’s primary product offering is the MiniMed 780G system, its second-generation automated insulin delivery system, which includes the MiniMed 780G insulin pump, the SmartGuard dosing algorithm, CGM sensors (Simplera Sync, Instinct, and Guardian 4), infusion sets, and reservoirs. The MiniMed 780G system received CE Mark approval in June 2020 ¹¹ and U.S. FDA approval in April 2023 ¹². The Simplera Sync CGM sensor received CE Mark approval in September 2023 ¹³ and U.S. FDA approval in April 2025 ¹⁴. The Instinct sensor, based on Abbott’s CGM technology, received U.S. FDA clearance as an ACE pump in July 2025 ¹⁵, and the SmartGuard algorithm received U.S. FDA clearance as an iAGC in September 2025 ¹⁶. The MiniMed 780G system with Instinct received CE Mark in February 2026 ¹⁷. As of October 2025, the company had more than 640,000 customers ¹⁸ in over 80 countries ¹⁹ on the MiniMed 780G system.

The company also offers the MiniMed Flex, its next-generation tubed insulin pump, which received FDA clearance in March 2026 ²⁰ and launched in the U.S. in June 2026 ²¹. The MiniMed Flex is 50% the size of the current MiniMed 780G ²² and features a 300-unit reservoir ²³. The MiniMed Go Smart MDI system, which includes a smart insulin pen and integration with Simplera Sync and Instinct CGMs, received U.S. FDA clearance and CE Mark approval ²⁴, and launched in the U.S. in May 2026 ²⁵. The company’s pipeline includes the MiniMed Fit patch pump with extended wear, which it aims to submit for U.S. FDA approval by fall of calendar year 2026 ²⁶, and the next-generation Vivera dosing algorithm, currently in pivotal trials initiated in February 2026 ²⁷. The company also offers the CareLink software platform, which has been enhanced since its inception in 2006 ²⁸.

On July 31, 2024, Medtronic MiniMed, Inc. entered into a global integration, supply, and distribution agreement with Abbott ²⁹, which was amended on June 1, 2026 ³⁰. Under the agreement, Abbott supplies the Instinct CGM sensor in exchange for a formula-based payment per unit, and Abbott is the exclusive supplier of third-party CGMs for certain AID and Smart MDI systems. The agreement has an initial term of seven years from June 1, 2026 ³¹. The company is also party to co-development agreements with Blackstone Life Sciences Advisors L.L.C. for the MiniMed Flex and MiniMed Fit patch pump. In connection with the U.S. FDA clearance of MiniMed Flex, the company recognized a one-time charge of $157 million ³² during the fourth quarter of fiscal year 2026 related to future minimum royalty payment obligations. During fiscal year 2025, two co-development agreements with Blackstone were terminated, including one that resulted in a one-time $165 million payment ³³ to Blackstone. The company recorded a pre-tax charge of $118 million ³⁴ during fiscal year 2026 related to the termination of certain arrangements with a third-party manufacturer for Simplera CGM high-volume automated manufacturing lines.

In fiscal year 2026, the company generated $3.1 billion ³⁵ in revenue, compared to $2.7 billion ³⁶ in fiscal year 2025. The company recorded a net loss of $317 million ³⁷ in fiscal year 2026 and a net loss of $198 million ³⁸ in fiscal year 2025. Adjusted EBITDA was $202 million ³⁹ in fiscal year 2026 and $253 million ⁴⁰ in fiscal year 2025. The net loss represented 10% ⁴¹ of revenue in fiscal year 2026 and 7% ⁴² of revenue in fiscal year 2025. Adjusted EBITDA represented 6% ⁴³ of revenue in fiscal year 2026 and 9% ⁴⁴ of revenue in fiscal year 2025.

The company plans to drive adoption of its current AID system generation by executing its commercial strategy and expanding clinical indications, including the recent U.S. FDA and CE Mark approval for use of the MiniMed 780G system by insulin-requiring T2D patients. The company believes the insulin-requiring T2D population is vastly underpenetrated around the world. Another key growth vector is increasing the global CGM Attachment Rate through the next-generation Simplera Sync CGM sensor. The company also aims to leverage its algorithm and dosing expertise to drive adoption of Smart MDI systems, including the MiniMed Go system, which launched in the U.S. in May 2026 ⁴⁵ and is expected to be distributed initially through the pharmacy channel in the United States.

The company plans to deliver breakthrough innovation with its pipeline, including the next-generation Vivera dosing algorithm designed to enable a "hands-free" AID system, and the MiniMed Fit patch pump with extended wear. The Vivera algorithm is currently in pivotal trials initiated in February 2026 ⁴⁶, with a U.S. launch expected in CY2027 ⁴⁷. The MiniMed Fit patch pump is expected to be submitted for U.S. FDA approval by fall of calendar year 2026 ⁴⁸, with a U.S. launch expected in CY2027 ⁴⁹. The company also plans to accelerate growth through strategic partnerships and tuck-in acquisition opportunities, leveraging its partnership with Abbott to expand CGM choice and access. The company expects to continue to pursue attractive strategic collaboration opportunities and be opportunistic in pursuing growth-enhancing partnerships and/or tuck-in acquisitions.

The company aims to grow profit and cash flow at a higher rate than revenues by driving sales of its full-system solution to generate greater revenue per customer, expanding margins through developing and building out new high-volume and automated manufacturing, and continuing to execute a regular cadence of cost transformation initiatives. The company believes its process for manufacturing sensors has potential for significant expansion at higher volumes. The company recorded a pre-tax charge of $118 million ⁵⁰ during fiscal year 2026 related to the termination of certain manufacturing arrangements, reflecting ongoing restructuring and cost optimization efforts.

The company operates two main manufacturing facilities in California and Puerto Rico, and two primary distribution hubs in Louisville, Kentucky and Heerlen, Netherlands, with 26 additional distribution facilities globally ⁵¹. The company leverages contract manufacturing partnerships for additional services. For the MiniMed Flex pump, the company aims to scale production capacity to approximately 100,000 units annually at launch ⁵² through its manufacturing partner. For the MiniMed Fit patch pump, the company has arranged for an initial launch capacity of approximately 20,000 patients annually ⁵³, with plans to scale. The company has a global employee base of approximately 8,000 ⁵⁴ dedicated employees as of April 2026, including over 2,800 ⁵⁵ commercial employees and over 1,100 ⁵⁶ research and development professionals.

The company deployed $448 million ⁵⁷ in research and development over the twelve months ended April 24, 2026, and $1.3 billion ⁵⁸ over the last three fiscal years. The filing does not disclose specific capital expenditure plans, share repurchase authorization amounts, or dividend policy figures beyond stating that the company does not expect to pay dividends on its common stock for the foreseeable future.

The company faces pricing pressure for certain products, including decreasing prices for its Guardian 4S, Simplera/Sync, and Instinct CGM products as a result of such pressure. The company has experienced rising costs due to heightened inflation and global trade policies. The company also faces risks related to supply chain disruptions, including a U.S. FDA warning letter issued to its sole supplier of infusion sets, Unomedical Device S.A. de C.V., on January 8, 2026 ⁵⁹, which identified violations of the U.S. FDA’s Quality System Regulation and Medical Device Reporting regulations. The company’s production of Simplera CGMs is scaling slower than anticipated due to initial unsuccessful attempts to develop high-volume automated manufacturing lines.

The company faces structural headwinds from competing products and therapeutic techniques, including emerging cellular therapeutic techniques such as islet cell therapy or immunotherapy, and GLP-1 treatments. The company expects that GLP-1s may reduce the number of people with T2D who require intensification of their therapy, but expects the use of GLP-1s by people with T1D will have an immaterial impact on its results of operations. The company also faces risks related to global operations, including fluctuations in currency exchange rates, healthcare reform legislation, economic sanctions, tariffs, and political and economic instability.

The company operates in a highly competitive industry and faces risks from competitors such as Beta Bionics, Inc.; Dexcom, Inc.; Insulet Corporation; Sequel Med Tech, LLC; and Tandem Diabetes Care, Inc. ⁶⁰, who may have greater financial and human resources. The company has experienced pricing pressure for certain products, including decreasing prices for its Guardian 4S, Simplera/Sync, and Instinct CGM products ⁶¹. A U.S. FDA warning letter issued to the sole supplier of infusion sets, Unomedical, on January 8, 2026 ⁶², could result in supply disruption, product recalls, and reputational harm. The company recorded a pre-tax charge of $118 million ⁶³ related to the termination of a third-party manufacturing agreement for Simplera CGM high-volume automated manufacturing lines that failed to meet throughput and yield requirements. The company is subject to risks related to its Blackstone co-development agreements, including potential termination payments up to $216 million ⁶⁴ for each such termination. The company faces risks from competing products and therapeutic techniques, including emerging cellular therapies and GLP-1 treatments, which could render its products obsolete or less desirable.

Management’s message emphasizes the company’s position as a scaled global medical technology company with a comprehensive suite of solutions for diabetes management, highlighting its pioneering innovation over more than 40 years ⁶⁵ and its mission to make every day a better day for people with diabetes. The filing states that management aims to achieve profitable growth with its strategy, and the company’s growth strategies include serving unmet needs with its current AID system generation, leveraging algorithm and dosing expertise to drive Smart MDI adoption, expanding CGM options through the Abbott partnership, delivering breakthrough innovation with its pipeline including next-generation AID systems, accelerating growth through strategic partnerships and tuck-in acquisitions, and driving profit margin expansion by capitalizing on the utilization of its fully integrated diabetes systems. The filing notes that the company recorded a net loss of $317 million ⁶⁶ and Adjusted EBITDA of $202 million ⁶⁷ in fiscal year 2026, and a net loss of $198 million ⁶⁸ and Adjusted EBITDA of $253 million ⁶⁹ in fiscal year 2025, with the aim to achieve profitable growth.