As filed with the Securities and Exchange Commission on December 19, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MiniMed Group, Inc. (Exact name of registrant as specified in its charter) (Primary Standard Industrial Classification Code Number) Delaware 3841 33-3985981 (I.R.S. Employer Identification Number) 18000 Devonshire St. Northridge, CA 91325 (763) 514-4000 (Address, including zip ...

Key Takeaways Revenues outside the United States rose 1.8% as TNDM shipped about 9,000 pumps across 25 markets. TNDM's strategic moves include CGM integrations, new pharmacy coverage gains and an ABT sensor agreement. TNDM plans direct sales in the U.K., Switzerland and Austria in early 2026 to tap global demand. Tandem Diabetes Care, Inc.’s (TNDM) impressive international expansion is expected to bolster growth in the upcoming quarters. The company’s impressive strategic initiatives provide a favorable opp ...

Core Insights - Insulet Corporation hosted its 2025 Investor Day, outlining a strategic plan to maintain leadership in the automated insulin delivery market for diabetes management [1][2][3] Strategic Plan and Market Focus - The company aims to drive growth in a total addressable market exceeding $30 billion by enhancing innovation, improving clinical practices, expanding access, and achieving commercial excellence [2][5] - Insulet's competitive advantages include its unique product design, a pay-as-you-go pharmacy model, advanced manufacturing capabilities, and a strong financial position [2][5] Financial Outlook (2025-2028) - Revenue is projected to grow at a compound annual growth rate (CAGR) of approximately 20% at constant currency rates, driven by increased adoption of Omnipod products and geographic expansion [7] - Adjusted operating margin is expected to expand by about 100 basis points annually, reflecting operational efficiencies [7] - Adjusted diluted earnings per share are anticipated to grow at a CAGR of over 25%, indicating a commitment to profitable growth [7] - Free cash flow is forecasted to remain strong, allowing for disciplined reinvestment in innovation and global scaling [7] Innovation Pipeline - Insulet introduced enhancements to the Omnipod 5, set to launch in 2026, along with two next-generation systems aimed at expanding market reach and improving automated insulin delivery [5][11] - The Omnipod 6, expected in 2027, will feature an adaptive algorithm for better glucose control and enhanced connectivity [11] - The Omnipod Fully Closed Loop for Type 2, planned for 2028, will be the first fully automated system designed specifically for type 2 diabetes, simplifying insulin delivery [11]

Company Overview - Insulet's 2024 revenue reached $2.1 billion[21] - The company has over 500,000 active Podders globally[21] - Approximately 365,000 users are utilizing Omnipod 5[21] Financial Performance and Growth - The company is growing revenue beyond $2.5 billion[25] - The company anticipates approximately 24% compound annual growth rate (CAGR)[25] - The company is experiencing greater than 660 basis points (bps) expansion in leading gross margin[25] - The company is experiencing approximately 1,010 bps expansion in adjusted operating margin[25] Omnipod 5 Impact and Market - Omnipod 5 demonstrated a 20%-23% increase in time in range for adults with Type 1 and Type 2 diabetes, respectively[28] - The company estimates a total addressable market of approximately 14 million patients[41] - U S Type 1 Diabetes market penetration is approximately 40%[40]

Core Insights - Insulet (PODD) has experienced a significant share price increase of 37.4% over the past year, outperforming the industry decline of 0.5% and the S&P 500's gain of 17.5% [1][8] - The company is enhancing its leadership in the diabetes market through the Omnipod 5, which is driving strong adoption and market growth [1][3] Company Overview - Insulet, based in Acton, MA, specializes in manufacturing and selling continuous insulin delivery systems for insulin-dependent diabetes [2] - The Omnipod platform offers a unique, tubeless insulin delivery system and is available in 25 countries [2] Growth Drivers - The share price rally is attributed to the strong momentum of Omnipod 5, the only FDA-cleared, fully disposable pod-based automated insulin delivery system [3] - Key product features such as on-body wearability and ease of use are contributing to rapid adoption [3] - Recent milestones include the U.S. launch of the Omnipod 5 App integrated with Dexcom G7 CGM system [3][4] Market Expansion - Omnipod DASH is gaining traction in the U.S. type 2 diabetes market, accounting for approximately 30% of new starts [4] - Insulet has received FDA clearance for type 2 label expansion for Omnipod 5, further enhancing its market position [4] - The company is expanding its market presence in Europe and has launched Omnipod Discover, a digital platform for personalized data management [5] Market Potential - The diabetes market remains underpenetrated, with only about 40% of the Type 1 diabetes population in the U.S. using insulin pump therapy [6] - Insulet is focusing on commercial expansion and market access, including salesforce growth and targeted pediatric center entry [9] Financial Estimates - The Zacks Consensus Estimate projects Insulet's earnings per share (EPS) to increase by 42.9% in 2025 and 24.3% in 2026, reaching $4.63 and $5.76 respectively [11] - Revenues are expected to grow by 26.4% in 2025 to $2.62 billion and by 18.1% in 2026 to $3.09 billion [11]

Company Overview and Market Position - Insulet is a global leader in diabetes management with $2.1 billion in 2024 revenue[21] - The company has approximately 500,000 active customers globally[21] - Omnipod is the 1 AID system requested and prescribed in the U S [21] - Omnipod 5 is the first AID system FDA-cleared for both type 1 and type 2 diabetes in the U S [21] Financial Performance and Growth - The company is growing revenue beyond $2.5 billion[24] - The company anticipates approximately 24%-27% constant currency revenue growth for full year 2025[25] - The company is experiencing rapid expansion of adjusted operating margin, with an anticipated expansion of approximately 1,000 bps to reach 17%-17 5%[24, 25] Product Innovation and Clinical Outcomes - Omnipod 5 is the first and only tubeless, waterproof AID in the U S [27] - Omnipod 5 leads to a 20%-23% increase in time in range for adults with type 1 and type 2 diabetes, respectively[27] - Strong SECURE-T2D clinical results show a 0 8% reduction in mean A1c in 13 weeks[29] Market Opportunity and Expansion - The total addressable market is approximately 14 million patients[40] - The company is expanding its market presence outside the U S [50] - The company is building the power of its Omnipod 5 brand globally[57]

Core Insights - Medtronic plc has received CE Mark approval in Europe to expand the indications for the MiniMed™ 780G system, allowing its use for individuals aged 2 years and older, during pregnancy, and for those with type 2 diabetes [1] Group 1: Expanded Indications - The MiniMed™ 780G system is now indicated for children aged 2-6 years with type 1 diabetes, showing a 0.6% reduction in HbA1C and a 9.9% increase in time in range when used in auto mode compared to manual mode [2] - The system has been recognized as a standard of care for children with type 1 diabetes across Europe, with guidelines from NICE and the German Diabetes Association recommending its use [3][4] Group 2: Pregnancy Management - The MiniMed™ 780G system offers significant benefits for managing type 1 diabetes during pregnancy, achieving an average Pregnancy Time in Range (TIRp) of 66.5%, which is an improvement over traditional insulin therapy [6] - Clinical guidelines emphasize the importance of tighter glucose control during pregnancy, with the MiniMed™ 780G system providing better overnight glucose control and higher treatment satisfaction among expectant mothers [5][6] Group 3: Type 2 Diabetes Indication - The MiniMed™ 780G system is now also approved for individuals with type 2 diabetes, demonstrating a 0.7% reduction in HbA1c and an increase in time in range to 80% in a pivotal trial [7] - Real-world data from 26,427 users with type 2 diabetes showed good glycemic control, exceeding the international consensus of 70% time in range [7] Group 4: Future Developments - Medtronic is working with U.S. regulatory authorities to expand the use of the MiniMed™ 780G system for individuals with type 2 diabetes, with ongoing clinical trials for children aged 2-6 years [8]

Financial Performance & Growth - Insulet achieved market-leading revenue growth and value creation[11] - The company is driving financial results through strong execution and margin expansion[7, 55] - In 2023, Insulet marked its 8th consecutive year of total company revenue growth of 20% or more[18] - Q3 2024 saw a gross margin of 693%, a +150 bps increase, and an operating margin of 162%, a +350 bps increase[18] - Q3 2024 U S revenue growth was 23%, total Omnipod revenue growth was 26%, and international revenue growth was 35%[18] - The company's revenue has grown from $07 billion in 2019 to $21 billion in 2024E, with a 23% CAGR[15] Omnipod 5 Platform & Clinical Outcomes - Omnipod 5 simplifies diabetes management and is winning on all dimensions[28, 31] - Omnipod 5 demonstrated a 175%-20% increase in time in range in adults with T1D and T2D, respectively[32] - Real-world results in 70000 Omnipod 5 users showed adults (18+ yrs) achieved 688% time in range and pediatrics (2-17 yrs) achieved 644% time in range[36, 37] - The SECURE-T2D trial demonstrated a 08% reduction in A1C with Omnipod 5 in T2D patients[39] Market Opportunity & Sustainability - Insulet is well-positioned for large market opportunities, with ~14M TAM across markets in different stages of pump penetration[23] - The company is focused on healthcare providers and direct-to-consumer initiatives to drive awareness[47] - Insulet is committed to sustainability, with initiatives including increased renewable energy generation (802kW potential) and a 77% reduced carbon footprint in redesigned U S Omnipod 5 starter kit packaging[48, 49]

Company Overview - Tandem Diabetes Care, Inc. (TNDM) has launched its t:slim X2 insulin pump with Control-IQ+ technology, now compatible with Abbott's FreeStyle Libre 3 Plus continuous glucose monitoring sensor in the U.S. An early access program has been initiated, with plans for broader availability in the second half of 2025 [1][9]. Stock Performance - Following the announcement of the new compatibility, TNDM's shares increased by 1.6%, reaching $20.55 [2]. However, over the past year, TNDM shares have experienced a decline of 49.4%, compared to a 14.8% decline in the industry [12]. Financial Metrics - Tandem Diabetes has a market capitalization of $1.35 billion and is projected to have an earnings per share (EPS) growth rate of 28.3% in 2025, significantly higher than the industry's expected growth of 13.8%. Revenue for 2025 is anticipated to rise by 10.6% [4]. Product Features - The t:slim X2 insulin pump utilizes advanced hybrid closed-loop technology, adjusting insulin delivery every five minutes based on predicted glucose values. It features the unique AutoBolus function, which calculates and delivers correction boluses for missed meals [5]. The FreeStyle Libre 3 Plus sensor offers a 15-day wear time and transmits glucose readings every minute to the t:slim mobile app [6]. Industry Insights - The global insulin delivery device market was valued at $16.43 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 7.9% by 2027, driven by the increasing prevalence of diabetes and advancements in technology [7][10]. Strategic Developments - Tandem Diabetes has entered an agreement to develop integrated diabetes solutions that will combine Abbott's future dual glucose-ketone sensor with Tandem's insulin delivery systems, enhancing options for diabetes management [11].

Financial Data and Key Metrics Changes - For the full year of 2024, the company achieved revenue of $2.1 billion, representing a growth of 22% year-over-year, marking the ninth consecutive year of 20% or more constant currency revenue growth [37][49] - Gross margin was reported at 69.8%, with an operating margin of 14.9% for the full year [37] - In the fourth quarter, total revenue growth was 17%, achieving the highest quarter of total revenue dollars [38] Business Line Data and Key Metrics Changes - U.S. Omnipod revenue grew by 12.4% in the fourth quarter, driven by strong demand for Omnipod 5 [39] - International Omnipod revenue grew by 33.1%, reflecting strong demand and adoption [42] - Drug Delivery revenue increased by 34.1%, exceeding guidance due to increased orders from partners [44] Market Data and Key Metrics Changes - The company reported an estimated 500,000 global customers using Omnipod, with 365,000 being active Omnipod 5 users [11] - Type 2 users represented over 30% of U.S. new customer starts in the fourth quarter, indicating significant market expansion [23] - The total addressable market for type 2 diabetes is estimated to be over 5.5 million people, with only about 5% currently penetrated [24] Company Strategy and Development Direction - The company focuses on three strategic areas: advancing the Omnipod 5 platform, leading growth in type 1 and type 2 markets in the U.S., and driving international access to Omnipod 5 [13] - The launch of Omnipod Discover aims to enhance patient engagement and outcomes through data management and insights [18] - The company plans to expand its U.S. sales force to increase reach and awareness among type 2 patients [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving growth objectives and executing strategic plans across U.S. and international markets [12] - The company anticipates total Omnipod revenue growth of 17% to 21% and total company revenue growth of 16% to 20% for 2025 [49] - Management highlighted the importance of type 2 market growth as a significant driver for future revenue [72] Other Important Information - The company ended the year with over $950 million in cash and cash equivalents, with a free cash flow of $305 million [48] - The gross margin for 2025 is expected to be approximately 70.5%, reflecting continued operational efficiencies [55] - The company will host an Investor Day on June 5 to provide further insights into its strategy and outlook [35] Q&A Session Summary Question: Insights on type 2 growth trajectory - Management confirmed strong growth in type 2 patients, with a significant response since the label launch in August, contributing to over 30% of new customer starts [66][72] Question: Feedback from thought leaders on type 2 - Management noted positive feedback from both patients and physicians regarding the ease of use of Omnipod 5, with increasing adoption among healthcare providers [75][78] Question: Guidance for Q1 U.S. revenue - Management clarified that the guidance for Q1 reflects normalized growth rates, considering seasonality and prior stocking dynamics [84] Question: Impact of sales force expansion on guidance - Management indicated that the guidance includes assumptions about the timely hiring and training of the expanded sales force, which is expected to enhance growth [88] Question: Competitive landscape for type 2 - Management expressed confidence in maintaining a dominant position in the type 2 market, emphasizing the advantages of Omnipod 5 and its first-mover status [124][127] Question: Type 2 adoption patterns - Management reported strong adoption across various segments of type 2 patients, with a focus on intensive insulin users [92][96]