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]