Aankondiging • Jun 09
Insulet Corporation Reveals New Data Supporting Omnipod 6 And Fully Closed-Loop Automated Insulin Delivery Systems Insulet Corporation announced new clinical results highlighting the next breakthroughs in tubeless Automated Insulin Delivery (AID) systems. Results from the STRIVE pivotal trial and the EVOLUTION 3 feasibility study, presented at the American Diabetes Association 86th Scientific Sessions in New Orleans, demonstrate meaningful improvements in glucose control for people with diabetes using Insulet’s future AID system — Omnipod 6 — and unique fully closed-loop (FCL) system for type 2 diabetes. The STRIVE pivotal trial was designed to evaluate the safety and efficacy of the next-generation Omnipod 6 algorithm. The randomized, crossover study included 132 participants across the U.S., including 98 with type 1 diabetes and 34 with type 2 diabetes. The type 1 cohort spanned a broad age range, including 29 participants aged 2 to <6 years, 36 aged 6 to <14 years, and 33 aged 14–70 years. Baseline glycemia was near recommended targets, with mean HbA1c values of 6.9% and 7.3% for type 1 and type 2 diabetes, respectively. Participants were randomized to use either the Omnipod 6 algorithm at the 100 mg/dL Target Glucose or the Omnipod 5 System at the 110 mg/dL Target Glucose for four weeks, followed by crossover to the alternate system for an additional four weeks. After the Crossover Phase, all participants entered a four-week or six-week Bolus Optional Phase to evaluate whether glycemic outcomes could be maintained with reduced user interaction, with a study goal of three or fewer boluses per day. The STRIVE study demonstrated clinically meaningful improvements in glycemic outcomes with Omnipod 6 during the Crossover Phase. Improved time in tight range (70–140 mg/dL) with Omnipod 6 vs. Omnipod 5: Type 1 diabetes (=14 years): 54% vs. 47% (+7 pts); Type 2 diabetes: 48% vs. 43% (+5 pts). Improved time in range (70–180 mg/dL) with Omnipod 6 vs. Omnipod 5: Type 1 diabetes (=14 years): 77% vs. 73% (+4 pts); Type 2 diabetes: 76% vs. 73% (+3 pts). Maintained safety profile: Time <54 mg/dL and <70 mg/dL were non-inferior. No instances of diabetic ketoacidosis or severe hypoglycemia. The STRIVE study demonstrated strong glycemic performance even when users bolused less during the Bolus Optional Phase. Strong time in range and time in tight range with fewer boluses: Type 1 diabetes (=14 years): 76% time in range and 54% time in tight range with 2.2 fewer boluses/day; Type 2 diabetes: 74% time in range and 46% time in tight range with 2.5 boluses per day. These findings suggest Omnipod 6 may be especially helpful for people with diabetes who do not always bolus. This will be further tested in the upcoming STRIVE 2 study, which will evaluate Omnipod 6 among people who bolus fewer than four times per day and are not meeting clinical targets for HbA1c. Insulet also shared results from EVOLUTION 3, the pre-pivotal study evaluating the safety and effectiveness of the Company’s breakthrough FCL system for adults with type 2 diabetes. EVOLUTION 3 enrolled a demographically diverse cohort comprised of 36 participants (adults aged 18–75 years old) with type 2 diabetes using insulin with HbA1c<14%. Participants were intensively managed with basal-bolus therapy and had high baseline utilization of continuous glucose monitoring. Yet they still had high baseline HbA1c of 8.1%. Insulet’s FCL for type 2 diabetes delivered 64% time in range, a 12% improvement with low hypoglycemia (0.15%) in a diverse, intensively managed population. Total daily insulin was reduced from 86U to 58U with no weight gain. Participants also reported high satisfaction (86% satisfied or highly satisfied) and reduced burden with FCL. This data is part of the broader clinical program used to support the development of the FCL AID system designed for people living with type 2 diabetes. The EVOLUTION 2 results were shared earlier this year at the 19International Conference on Advanced Technologies & Treatments for Diabetes, and Insulet recently announced the first enrollment of participants in EVOLVE, the randomized controlled pivotal trial supporting a planned 2027 510(k) filing to the FDA and expected 2028 commercial launch. Building on this experience from FCL for type 2 diabetes, early clinical work is underway to advance the science for FCL for type 1 diabetes as well. Insulet’s Omnipod 6 and FCL System for type 2 diabetes are investigational devices. Limited by federal (or United States) law to investigational use. These products have not been reviewed by the FDA or any other regulatory agency. Recent Insider Transactions • Jun 04
Independent Chair recently bought Mex$8.6m worth of stock On the 3rd of June, Elizabeth Weatherman bought around 3k shares on-market at roughly Mex$2,496 per share. This transaction amounted to 66% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Elizabeth's only on-market trade for the last 12 months. Aankondiging • May 27
Insulet Initiates Voluntary Medical Device Correction For Certain Omnipod Pods In The U.S. And Affected International Markets Insulet Corporation Inc. announced a voluntary Medical Device Correction for specific lots of Omnipod 5, Omnipod DASH, and Omnipod Insulin Management System (Omnipod Eros) Pods due to a manufacturing issue, identified through ongoing product monitoring, that could result in insulin under-delivery. This action is separate from the voluntary Medical Device Correction issued on March 12, 2026 affecting certain Omnipod 5 Pods in the U.S. and includes certain Pod lots distributed in the U.S. and affected international markets. Pods not included in the affected lots remain safe to use. Insulet identified that some Pods from specific lots may have a small tear in the tubing (cannula) just above the skin, between the Pod and the point where the cannula enters the body. If this occurs, insulin may leak outside of the Pod instead of being fully delivered into the body as intended, potentially leading to under-delivery of insulin. Individuals using an affected Pod may notice wetness on their skin or Pod adhesive or detect the smell of insulin. However, in some cases, this issue may be difficult to detect and go unnoticed. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a serious medical condition that requires prompt medical treatment and can be life-threatening if not treated. Approximately 7 million Pods are included within the scope of this action, approximately 60% of which have been consumed or are expired. The Pods affected by this correction represent approximately 8.5% of 2025 global Omnipod Pod production. Globally, there have been 24 reports of serious adverse events associated with high blood glucose levels, including hospitalization and DKA. There have been no deaths reported. This issue does not affect continuous glucose monitoring (CGM) systems or CGM readings. The issue was identified through the Company’s ongoing product monitoring. Insulet has identified the cause of this manufacturing issue and implemented corrective actions designed to prevent recurrence. In addition, the Company has further strengthened its in-process monitoring and quality controls designed to detect cannula tears of this nature. Insulet is communicating proactively with affected customers and providing clear instructions to help them identify affected lots, discontinue use of impacted Pods, and obtain replacement Pods at no cost. The Company has sufficient supply available to replace affected Pods and does not anticipate any disruption to product availability. The U.S. Food and Drug Administration (FDA) and all other relevant regulatory authorities have been notified of this action. Aankondiging • May 05
Insulet Corporation Initiates Evolve Pivotal Study to Advance Fully Closed-Loop Automated Insulin Delivery System for Type 2 Diabetes Insulet Corporation has enrolled the first participant in a pivotal study for its fully closed-loop (FCL) automated insulin delivery (AID) system for type 2 diabetes (T2D). FCL for T2D is a breakthrough innovation intended to further improve glycemic outcomes with less burden for users across diverse care settings. That includes eliminating user interactions for bolusing and mealtime announcements for people with T2D as well as settings to start and onboard. Advancing AID Through a Fully Closed Loop System: The EVOLVE clinical study is a multi-center randomized control trial actively enrolling up to 350 adults across a maximum of 40 U.S. sites. The participants are between 18 – 75 years of age, living with T2D and using insulin (basal-bolus or basal-only). The Company received Investigational Device Exemption (IDE) approval in March 2026 from the U.S. Food and Drug Administration (FDA). The Company aims to remove barriers and expand access to AID, particularly in primary care, where approximately 70% of people with T2D are managed. By streamlining onboarding and training and eliminating start-up settings, Insulet’s FCL for T2D is designed to reduce workload and support healthcare professionals across specialties and care settings. The EVOLVE Pivotal Study follows a three-part series of feasibility studies to support the development of Insulet’s FCL AID system. The Company presented promising feasibility results at the 19International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Barcelona, Spain, including a 24% time in range (TIR) improvement, for an average of 68%, over standard injection therapy. In 2024, Insulet shared results from its landmark SECURE-T2D pivotal trial, demonstrating improved glycemic outcomes with Omnipod 5 compared with prior insulin injection or pump therapy in adults with T2D. Participants experienced a reduction in HbA1c from 8.2% to 7.4% and a 20% increase in TIR– from 45% to 66% or 4.8 hours daily. With these results, Insulet was the first company to receive 510(k) clearance for an AID system, Omnipod 5, for adults with T2D. Since then, the Company has seen impressive adoption rates and real-world evidence of glycemic improvements including more than 80% TIR with optimized settings for people with T2D using Omnipod 5. While Insulet’s type 2 prescriber base in the U.S. grew by more than 60% in 2025 to more than 6,500 clinicians, AID adoption remains well below 5% for the estimated 5.5 million people with T2D who require insulin. Insulet is committed to continuing to expand adoption of AID for this population, as recommended by the American Diabetes Association’s 2026 Standards of Care. The Company plans to submit a 510(k) filing to the FDA in 2027 and launch its FCL AID system for T2D in 2028. The FCL AID System is an investigational device. Limited by Federal (or United States) law to investigational use. This product has not been reviewed by the FDA or any other regulatory agency. Venkatraman S, et al. Trends and Disparities in Glycemic Control and Severe Hyperglycemia Among U.S. Adults with Diabetes Using Insulin, 1988-22020. JAMA Netw Open. 2022 Dec 1;5(12). The EVOLVE study will evaluate a new fully closed-looped AID system for Type 2 diabetes. Retrospective RWE data on file. 2025. Results shown for T2D users with optimized settings including sufficient CGM data (=75% of days with =220 readings), =90% time in Automated Mode, =3 bolus/day and an average Target Glucose of 110-115 mg/dL (6.1-6.4 mmol/L). Optimized settings: ISF x TDI =1500, I:C Ratio x TDI =350. RF-062025-00014. Aankondiging • Apr 07
Insulet Corporation, Annual General Meeting, May 20, 2026 Insulet Corporation, Annual General Meeting, May 20, 2026. Aankondiging • Apr 01
Insulet Corporation to Report Q1, 2026 Results on May 06, 2026 Insulet Corporation announced that they will report Q1, 2026 results Pre-Market on May 06, 2026 Aankondiging • Mar 30
Insulet Corporation Appoints Mike Panos as Executive Vice President and Chief Commercial Officer, Effective March 30, 2026 Insulet Corporation announced the appointment of Mike Panos as Executive Vice President, Chief Commercial Officer, effective March 30, 2026. In this role, Mr. Panos will lead Insulet’s global commercial organization, reporting to President and Chief Executive Officer Ashley McEvoy. He will also be a member of the Executive Leadership Team. Mr. Panos brings 30 years of commercial leadership experience in the medical technology sector, most recently serving as Leader, Sales Excellence at Stryker Corporation. Over his three-decade career at Stryker, he held multiple senior leadership roles, including President of the Trauma and Extremities Division and President of North America and Global R&D. He is widely recognized for developing top talent, instilling rigorous commercial discipline, and leading large, global teams to deliver both top-line growth and operational performance. Mr. Panos is a Boston College graduate and long-time Boston-area resident, bringing deep ties to the region and local leadership experience to Insulet’s Massachusetts-based team. At Insulet, Mr. Panos will lead the Company’s global commercial organization, with responsibility for driving commercial strategy and execution across geographies, expanding market access, and strengthening capabilities to support continued growth and reach, including expanding into new patient populations and care settings. Aankondiging • Mar 13
Insulet Corporation Initiates Voluntary Medical Device Correction For Certain Omnipod 5 Pods In The U.S Insulet Corporation initiated a voluntary Medical Device Correction for specific lots of Omnipod 5 Pods after identifying a manufacturing issue through its ongoing product monitoring. This action applies to specific identified lots distributed in the United States, and all other Omnipod 5 Pods and Omnipod products remain safe to use. Insulet identified that certain Pods from specific lots may have a small tear in the internal tubing that delivers insulin. If this occurs, insulin may leak inside the Pod instead of being fully infused into the body as intended. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a serious medical condition that requires prompt medical treatment. Insulet has received 18 reports of serious adverse events associated with high blood glucose levels, including hospitalization and DKA. No deaths have been reported. This issue does not affect continuous glucose monitoring (CGM) systems or CGM readings. Following its investigation, Insulet has implemented updates to its manufacturing processes and quality controls to strengthen detection and prevention and further support the integrity of its products. The Pods involved in this correction represent approximately 1.5% of annual Omnipod 5 pod production globally. Insulet continues to manufacture and ship Omnipod 5 Pods and does not anticipate disruption to customer shipments, product availability, or new patient starts. The U.S. Food and Drug Administration has been notified of this action. Customers should visit omnipod.com/check-pods to confirm whether their Pod lot number is included in this voluntary Medical Device Correction and request replacement Pods at no cost. If a Pod from an affected lot is currently in use, customers should discontinue use and replace it with a Pod from an unaffected lot. Customers who have questions or need assistance may contact Insulet Product Support at 1-800-641-2049 (available 24/7) or use the live agent chat at omnipod.com/current-podders. Aankondiging • Mar 12
Insulet Corporation Presents Promising Study Results For Fully Closed-Loop Automated Insulin Delivery System For Adults With Type 2 Diabetes Insulet Corporation shared new clinical evidence related to the development of its first fully closed-loop automated insulin delivery system for type 2 diabetes. Outcomes from EVOLUTION 2 study include 68% time in range with no boluses. Diverse multicenter feasibility study highlights the promise of future Omnipod innovation to address unmet needs, improve outcomes, and redefine user and clinician experience. Presented at the 19th International Conference on Advanced Technologies & Treatments for Diabetes in Barcelona, Spain, EVOLUTION 2 is the second in a series of feasibility studies supporting the development of an Omnipod fully closed-loop system. This multicenter feasibility study was designed to drive rapid innovation, allowing investigators to evaluate multiple versions of the algorithm to support continued fully closed-loop system development. It included 24 adults in a highly diverse cohort from New Zealand, aged 16-70 years with type 2 diabetes using insulin (basal-bolus or basal-only, pumps or injections with HbA1c under 12.0%). The participants had lived with type 2 diabetes for an average of 16 years. When using the final algorithm version of fully closed-loop with no boluses, the participants’ time in range increased to an average of 68%, a 24% improvement over standard injection therapy. Time Below Range remained very low, with a median of 0.14% below 70 mg/dL—well under the American Diabetes Association’s recommended threshold of less than 4%. No severe hypoglycemia or diabetic ketoacidosis events were observed. Users experienced improved glycemic outcomes without compromising on low glucose events. The benefits were observed across a diverse set of participant characteristics including sex, ethnicity, baseline HbA1c, and body mass index. More than 90% of participants chose to continue into the ongoing extension phase, showing strong interest and positive experiences with the fully closed-loop system. EVOLUTION 2 builds on the 2024 EVOLUTION 1 feasibility study, which was the first evaluation of the Omnipod fully closed-loop algorithm in adults with type 2 diabetes. Participants in the EVOLUTION 1 study experienced significant improvements in time in range, from 52% to 65%, without boluses, representing more than three additional hours per day in target range with minimal hypoglycemia. Insulet used these results to fine-tune the algorithm design, focusing on further simplifying the user experience and laying the groundwork for additional improvements studied with EVOLUTION 2. The company plans to start its pivotal study (EVOLVE) in 2026 to support a 510(k) filing in 2027 and a commercial launch in 2028. Aankondiging • Mar 10
Insulet Corporation Presents Evolution 2 Results and Demonstrates Omnipod Fully Closed-Loop System for Adults with Type 2 Diabetes Insulet Corporation announced to present new clinical evidence related to its first fully closed-loop (FCL) automated insulin delivery (AID) system for type 2 diabetes (T2D) at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD), taking place March 11 – 14, 2026 in Barcelona, Spain, and online. The EVOLUTION 2 study results will be presented at Insulet’s symposium by Dr. Martin de Bock, Professor and Pediatric Endocrinologist at the University of Otago, Christchurch in New Zealand. This study is part of a series of EVOLUTION feasibility studies to test the safety and efficacy of the T2D FCL System which eliminates burden from dosing decisions and simplifies the provider experience. The symposium, entitled “Omnipod: Breakthrough Simplicity. Better Control. Fully Closing the Loop.” will take place on Wednesday, March 11 from 2:40 – 4:10 p.m. CET in Hall 112. In addition to Dr. de Bock’s presentation of EVOLUTION 2, the symposium will focus on glycemic improvements with Omnipod 5 and the importance of AID technology as standard of care for people with diabetes. A total of seven posters and presentations on the Omnipod 5 System, the Omnipod DASH Insulin Management System, and future innovations will be presented at ATTD. Oral Presentations include: Settings Associated with Optimal Outcomes with the Omnipod 5 Automated Insulin Delivery System: Evidence from Real-World Users with Type 2 Diabetes with Dr. Grazia Aleppo: 10:30 – 10:40 a.m. CET, Hall 115; Glycemic Outcomes with the Omnipod 5 Automated Insulin Delivery System in Users with Low Insulin Requirements (fewer than 5 units/day): Evidence from Real-World Users with Dr. Lori Laffel: 13:45 – 13:55 p.m. CET, Hall 113; Settings Associated with Optimal Outcomes with the Omnipod 5 Automated Insulin Delivery System: Evidence from Real-World Users with Type 1 Diabetes with Dr. Gregory Forlenza: 13:55 – 14:05 p.m. CET, Hall 113; Glycemic Outcomes with the Omnipod 5 Automated Insulin Delivery System in Infants and Toddlers with Dr. Jamie Wood: 14:05 – 14:15 p.m. CET, Hall 113; Tubed or Tubeless Insulin Pumps? A Retrospective Real-World Analysis of National French Health Data with Pr. Bogdan Nicolescu-Catargi: 14:45 p.m., Hall 212. Poster Presentations include: e-Poster EP070 – Outpatient Evaluation of a Next-Generation Fully Closed-Loop Algorithm for Omnipod in Adults with Type 2 Diabetes with Dr. Martin de Bock; e-Poster EP082 – Improved Health-related Quality of Life for Adults with Type 1 Diabetes: Impact of Tubeless Therapy on the Implementation Plan for Automated Insulin Delivery in England with Dr. Jackie Elliott. e-Poster presentations will be available throughout the entire conference. Clinical experts will offer hands-on Omnipod product demonstrations to conference attendees at the Omnipod booth (38), offering attendees the chance to experience Omnipod 5. An immersive, multi-media experience inside an inflatable dome will also be available on Wednesday evening and Thursday during exhibit hall hours. The dome will include a 180-degree video screen and other sensory displays to tell Insulet’s story and showcase how Omnipod 5 is transforming diabetes management. Throughout the show, Insulet will record episodes for its Beyond the Bolus, TypeCast, and Within Range podcasts, featuring interviews with various healthcare providers, thought leaders, and Omnipod users. Visitors will be able to listen to these conversations live from a dedicated space next to the main Omnipod exhibit. Sr. Research Analyst Jeff Johnson of Baird will be hosting a webcast featuring Dr. Ly on Friday, March 13, at 3:00 PM CET. The interview will feature a recap of highlights, new clinical data, and updates from ATTD. Aankondiging • Feb 18
Insulet Corporation Provides Earnings Guidance for the First Quarter Ending March 31, 2026 and Year Ending December 31, 2026 Insulet Corporation provided earnings guidance for the first quarter ending March 31, 2026 and year ending December 31, 2026. for the quarter, the company expects GAAP revenue growth of 21% - 23%.
for the year, the company expects GAAP revenue growth of 27% - 29%. Aankondiging • Feb 05
Insulet Launches Omnipod® 5 and Omnipod Discover™ in the Middle East to Transform Diabetes Care Insulet Corporation announced its transformative Omnipod 5 Automated Insulin Delivery (AID) System is now available in the Middle East - including Saudi Arabia, Kuwait, Qatar, and the United Arab Emirates (UAE). The Company is making the announcement at the 16th edition of the Emirates Diabetes and Endocrine Congress (EDEC) in Dubai. The Omnipod 5 System simplifies diabetes management and has demonstrated strong glycemic outcomes, including improved time in range and lowering HbA1c, by automatically adjusting insulin delivery every five minutes and eliminating the need for multiple daily injections (MDI)2. The waterproof3, discreet, and wearable Omnipod 5 is the first tubeless AID system that communicates with a sensor and proactively corrects for highs and helps to protect against lows, day and night4,5. Omnipod 5 is indicated for individuals aged two years and older with type 1 diabetes and compatible with the Abbott FreeStyle Libre 2 Plus sensor and the Dexcom G7 sensor in Saudi Arabia, Kuwait, and the UAE, and with the Dexcom G 7 sensor in Qatar. Omnipod Discover: Diabetes Data Management - Simplified: Insulet is also launching Omnipod Discover, a proprietary and retrospective data analytics and reporting platform designed for Omnipod 5 users, their caregivers, and healthcare providers. Easy to access, Omnipod Discover streamlines the analysis of glucose and insulin delivery data and delivers meaningful insights -- transforming complex information into clear, relevant trends and recommendations that inform diabetes management. Its web-based intuitive display shows how the Omnipod 5 algorithm automates insulin delivery, enabling understanding of trends to make decisions confidently. Users can also access their data with insights in a simplified way that empowers them to understand and manage their diabetes. Omnipod Discover is being introduced in these Middle Eastern markets first, with plans to expand to other countries where Omnipod 5 is available. With these new market launches, Omnipod 5 is now available globally in 19 countries with plans to launch in Spain (a new market for Insulet) in 2026, followed by Greece and Croatia in the first half of 2027. Aankondiging • Jan 09
Insulet Corporation to Report Q4, 2025 Results on Feb 18, 2026 Insulet Corporation announced that they will report Q4, 2025 results at 9:30 AM, US Eastern Standard Time on Feb 18, 2026 Aankondiging • Dec 04
Insulet Corporation Announces FDA 510(k) Clearance of Omnipod® 5 Algorithm Enhancements That Redefine Insulin Delivery and Simplify the Pod Experience Insulet Corporation announced it has received FDA 510(k) clearance for significant enhancements to the Omnipod 5 Automated Insulin Delivery System. These updates to the Omnipod 5 algorithm set a new benchmark in tubeless diabetes technology by offering a lower 100 mg/dL Target Glucose option and a more seamless automated experience. More Flexibility with a Lower Target Glucose Setting: The new 100 mg/dL Target GlUCose expands Omnipod 5's customization range to six settings between 100-150 mg/dL in 10 mg/dL increments. This flexibility allows healthcare providers to tailor insulin delivery more precisely, supporting individuals seeking tighter glucose management or those striving to meet specific glucose goals. It also directly impacts automated insulin delivery and improves the algorithm's responsiveness. Real world evidence has shown that lowering the glucose target is associated with increased time in range, with no clinically meaningful change in Time Below Range1 (TBR). In addition, the upgraded Omnipod 5 algorithm helps users stay in Automated Mode with fewer interruptions, even during prolonged high glucose events. These advancements are designed to deliver strong clinical results with increased flexibility and greater ease of use, with fewer interruptions to daily life. The updates to the Omnipod5 algorithm are anticipated to launch in the United States in the first half of 2026, where Omnipod 5 is cleared for people aged 2 and older with type 1 and aged 18 and older with type 2 diabetes. Aankondiging • Nov 06
Insulet Corporation Provides Revenue Guidance for the Fourth Quarter and Full Year Ending December 31, 2025 Insulet Corporation provided revenue guidance for the fourth quarter and full year ending December 31, 2025. For the quarter, the company expects total omnipod revenue in constant currency 27%-30% as compared to 25%-28% from a year ago.
For the full year, the company expects revenue in constant currency of 28%-29% as compared to 24%-27% from a year ago. Aankondiging • Oct 23
Insulet Corporation Appoints Robert L. Huffines to the Board of Directors and Audit Committee, Effective October 31, 2025 On October 21, 2025, Insulet Corporation announced the appointment of Robert L. Huffines, a former Global Chair of Investment Banking at JP Morgan Chase & Co., to the Company’s board of directors, as a Class II director, effective October 31, 2025. Mr. Huffines joins the board as an independent director and will serve on the board’s Audit Committee. Mr. Huffines joined J.P. Morgan in 1992 in the Mergers and Acquisitions group, with a focus on the healthcare industry. From 2002 to 2010, he served as co-head of the company’s global healthcare investment banking group, and, from 2011 to 2020, Mr. Huffines served as JP Morgan Chase’s Vice Chairman of Investment Banking. From 2020 to 2024, Mr. Huffines was the company’s Global Chair of Investment Banking and a member of the Executive Committee. Prior to joining J.P. Morgan, he worked at Alex Brown & Sons, specializing in equity financing and advisory assignments for emerging growth companies. Mr. Huffines and his wife, Lisa Huffines, founded The Forest Group Inc., a not-for-profit organization focused on improving the mental health of children in underserved communities. Mr. Huffines currently serves on the boards of directors of Nextech Invest Ltd., Eikon Therapeutics, and the Hastings Center for Biomedical Ethics. He also served as a director of Walgreens Boots Alliance until its sale in August 2025. Mr. Huffines earned his M.B.A. from the Darden School of Business at the University of Virginia, where he received the Faculty Award for academic excellence. He pursued his baccalaureate education at the University of North Carolina, where he majored in English and Economics. Aankondiging • Aug 26
Insulet Corporation Announces Executive Appointments Insulet Corporation announced the appointment of Eric Benjamin to Chief Operating Officer effective immediately. The Company also announced the appointment of Manoj Raghunandanan as Chief Growth Officer. In this expanded role, Mr. Benjamin will lead Insulet’s end-to-end growth and innovation engine, setting strategy and guiding execution across new products, new markets, and commercial expansion. He will oversee Strategy & Business Development, the Office of the Chief Technology Officer, Research & Development, and a newly-created Growth organization, ensuring strong alignment across teams to drive growth and advance the Company’s strategic priorities. Since joining Insulet in 2015, Mr. Benjamin has been instrumental in transforming the Company into an innovation-driven leader in diabetes care. Through a series of progressive leadership roles, he has strengthened supply chain resilience, launched Omnipod DASH® and Omnipod 5®, expanded Insulet’s reach into the type 2 diabetes market, and digitized the customer experience to improve customer engagement and satisfaction. Most recently, as Executive Vice President, Chief Product & Customer Experience Officer, Mr. Benjamin directed global product strategy, customer experience, commercial execution, and Insulet’s innovation roadmap. With the expansion of Mr. Benjamin’s remit, Insulet also announced the appointment of Manoj Raghunandanan as Chief Growth Officer. Mr. Raghunandanan brings more than 20 years of global consumer health leadership experience at Kenvue (formerly Johnson & Johnson Consumer Health). He most recently served as general manager of their Northern European business and previously sat on the Executive Committee for five years overseeing a $6 billion global OTC portfolio. He has held senior leadership roles in the U.S., Europe, and Asia, building high-performing teams, driving commercial excellence, and scaling global brands. Mr. Raghunandanan will lead Insulet’s newly-formed Growth organization, developing global strategy, overseeing demand generation, accelerating commercial capabilities, and stewarding the global brand and customer experience to accelerate the Company’s next chapter of global growth. Aankondiging • Jul 08
Insulet Corporation to Report Q2, 2025 Results on Aug 07, 2025 Insulet Corporation announced that they will report Q2, 2025 results Pre-Market on Aug 07, 2025 Recent Insider Transactions • Jun 13
Insider recently sold Mex$2.8m worth of stock On the 9th of June, Luciana Borio sold around 481 shares on-market at roughly Mex$5,825 per share. This transaction amounted to 17% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of Mex$88m more than they bought in the last 12 months. Aankondiging • Jun 10
Insulet Corporation's Omnipod 5 App for Iphone with Dexcom G7 Integration Now Available to All U.S. Users Insulet Corporation announced that the Omnipod®? 5 App for iPhone is now compatible with the Dexcom G7 Continuous Glucose Monitoring (CGM) System. With this latest integration, the Omnipod 5 Automated Insulin Delivery (AID) System combines the benefits of tubeless AID and Dexcom's latest diabetes management technology, all conveniently controlled from an iPhone. Omnipod 5 proactively adjusts insulin delivery every five minutes, autoc incorrects for high glucose, and helps protect against lows, day and night--even while sleep. The Omnipod 5 App for iPhone, available in the U.S., offers full control of Omnipod 5 including the ability to bolus, change a Pod, adjust settings, access valuable insights, and more. The Omnipod 5 app with Dexcom G7 and Dexcom G6 compatibility is now available for download on the Apple App Store. Aankondiging • May 01
Insulet Corporation, Annual General Meeting, May 22, 2025 Insulet Corporation, Annual General Meeting, May 22, 2025. Aankondiging • Apr 07
Insulet Corporation Launches Omnipod 5 Automated Insulin Delivery System in Canada Insulet Corporation announced that Omnipod 5 is now commercially available in Canada. Omnipod 5 is the first tubeless, waterproof Automated Insulin Delivery (AID) System approved for use in Canada for people with type 1 diabetes ages two years and above. The Omnipod 5 AID System is compatible in Canada with the Dexcom G6 and Dexcom G7 Continuous Glucose Monitoring (CGM) Systems to continuously adapt and automatically deliver insulin according to the user's personal needs, simplifying diabetes for patients. Public reimbursement for Omnipod 5 is currently in place in Ontario and Nova Scotia. Insulet is actively working to expand Omnipod 5 coverage across additional provinces and territories throughout the country. Living with diabetes is very burdensome and often involves constant monitoring and multiple daily injections, or dealing with cumbersome pumps with tubing, all of which can contribute to the constant stress of managing glucose levels. In fact, people with diabetes make an estimated 180 more decisions each day about their health than someone without diabetes4. Omnipod 5 is designed to make living with diabetes simpler, delivering exceptional ease of use; it automatically manages glucose levels, eliminating multiple daily injections, insulin pump tubing or routine fingersticks, providing a seamless and intuitive System that adjusts insulin doses automatically based on real-time glucose readings. Aankondiging • Apr 03
Insulet Corporation to Report Q1, 2025 Results on May 08, 2025 Insulet Corporation announced that they will report Q1, 2025 results at 4:00 PM, US Eastern Standard Time on May 08, 2025 Aankondiging • Feb 21
Insulet Corporation Provides Revenue Guidance for the First Quarter Ending March 31, 2025 and Full Year Ending December 31, 2025 Insulet Corporation provided revenue guidance for the first quarter ending March 31, 2025 and full year ending December 31, 2025. For the quarter, the company expects revenue growth of 22% to 25%. Revenue growth ranges by product line are: Total Omnipod of 17% to 21% - U.S. Omnipod of 16% to 20% and International Omnipod of 22% to 26%; and Drug Delivery of (55)% to (45)%.
For the year, the Company expects revenue growth of 16% to 20%. Revenue growth ranges by product line are: Total Omnipod of 23% to 26% - U.S. Omnipod of 21% to 24% and International Omnipod of 28% to 31%; and Drug Delivery of (10)% to (5)%. Aankondiging • Jan 14
Insulet Launches Revolutionary Omnipod 5 in Five More Countries in Europe Insulet Corporation announced the Omnipod 5 Automated Insulin Delivery System is now commercially available in five more countries--Italy, Denmark, Finland, Norway, and Sweden. Omnipod 5 is now available with both Abbott's FreeStyle Libre 2 Plus and Dexcom G6 Continuous Glucose Monitoring (CGM) sensor compatibility. Indicated for individuals aged two years and older with type 1 diabetes, Omnipod 5 is the first and only tubeless automated insulin delivery (AID) system integrated with both leading CGM sensor brands. Omnipod is recognized as the number one insulin pump for new pump users in Europe1. Omnipod 5 is also the number one prescribed AID system in the U.S.2 and the first tubeless, waterproof3 AID system with proactive Glucose control designed to deliver exceptional ease of use. It was first introduced in the U.S. in 2022, integrated with Dexcom G6, and has demonstrated strong clinical results with real world evidence including lower A1c and improved time in range, while maintaining low time in hypoglycemia. Sensor integration with Abbott's FreeStyle Libre 2 plus and Dexcom G6 allows many users to benefit from Omnipod 5 with their sensor of choice. It also gives prescribers more flexibility when recommending a sensor for their patients, making it fast and easy to start AID therapy with Omnipod 5. Aankondiging • Jan 10
Insulet Corporation to Report Q4, 2024 Results on Feb 20, 2025 Insulet Corporation announced that they will report Q4, 2024 results After-Market on Feb 20, 2025 Recent Insider Transactions • Dec 13
Group VP recently sold Mex$5.1m worth of stock On the 10th of December, Lauren Budden sold around 915 shares on-market at roughly Mex$5,587 per share. This transaction amounted to 21% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of Mex$95m more than they bought in the last 12 months. Recent Insider Transactions • Nov 16
Insider recently sold Mex$2.9m worth of stock On the 12th of November, Luciana Borio sold around 508 shares on-market at roughly Mex$5,647 per share. This transaction amounted to 26% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth Mex$23m. Insiders have been net sellers, collectively disposing of Mex$90m more than they bought in the last 12 months. Valuation Update With 7 Day Price Move • Nov 15
Investor sentiment improves as stock rises 17% After last week's 17% share price gain to Mex$5,519, the stock trades at a forward P/E ratio of 61x. Average forward P/E is 14x in the Medical Equipment industry globally. Total loss to shareholders of 8.9% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at Mex$3,672 per share. Reported Earnings • Nov 09
Third quarter 2024 earnings released: EPS: US$1.11 (vs US$0.74 in 3Q 2023) Third quarter 2024 results: EPS: US$1.11 (up from US$0.74 in 3Q 2023). Revenue: US$543.9m (up 26% from 3Q 2023). Net income: US$77.5m (up 49% from 3Q 2023). Profit margin: 14% (up from 12% in 3Q 2023). The increase in margin was driven by higher revenue. Revenue is forecast to grow 14% p.a. on average during the next 3 years, compared to a 9.0% growth forecast for the Global Medical Equipment industry. Over the last 3 years on average, earnings per share has increased by 110% per year but the company’s share price has fallen by 8% per year, which means it is significantly lagging earnings. Aankondiging • Oct 30
Omnipod 5 App for Iphone Now Fully Available in the United States Insulet Corporation with its Omnipod brand of products, announced the full market release of the Omnipod 5 App for iPhone in the U.S. Now available to download for free on the Apple App Store, the App allows users to fully control their Omnipod 5 Automated Insulin Delivery System (Omnipod 5) from their compatible iPhone1. For example, users can bolus for a meal, change a Pod, and adjust settings. Importantly, this also means that Omnipod 5 users who have a compatible iPhone no longer need to carry a separate Controller to help manage their insulin delivery requirements. The Omnipod 5 App for iPhone offers unique capabilities, such as a Custom Foods feature that allows users to input, save, and list carbohydrate counts for their typical meal sizes, favorite foods, and snacks. Users can select from their personalized list of foods when using the SmartBolus Calculator to determine how much insulin to receive for a meal, thus minimizing carb counting and simplifying mealtime math. Designed and repeatedly tested with Omnipod 5 users to deliver meaningful improvements over their experience with a Controller, the Omnipod 5 App for iPhone has an intuitive user interface that includes real time glucose information directly on the home screen. The Omnipod 5 App for iPhone is currently compatible with the Dexcom G6 Continuous Glucose Monitoring System and is expected to be compatible with the Dexcom G7 CGM in the U.S. in 2025. The Omnipod 5 App for Android phones is also available to U.S. customers. Aankondiging • Oct 01
Insulet Corporation to Report Q3, 2024 Results on Nov 07, 2024 Insulet Corporation announced that they will report Q3, 2024 results After-Market on Nov 07, 2024 Recent Insider Transactions • Sep 11
Senior VP & CTO recently sold Mex$6.1m worth of stock On the 9th of September, Mark Field sold around 1k shares on-market at roughly Mex$4,393 per share. This transaction amounted to 12% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth Mex$7.2m. Insiders have been net sellers, collectively disposing of Mex$101m more than they bought in the last 12 months. Valuation Update With 7 Day Price Move • Sep 06
Investor sentiment improves as stock rises 19% After last week's 19% share price gain to Mex$4,260, the stock trades at a forward P/E ratio of 47x. Average forward P/E is 13x in the Medical Equipment industry globally. Simply Wall St's valuation model estimates the intrinsic value at Mex$3,492 per share. Recent Insider Transactions • Aug 30
Senior VP & CTO recently sold Mex$5.5m worth of stock On the 28th of August, Mark Field sold around 1k shares on-market at roughly Mex$3,954 per share. This transaction amounted to 11% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth Mex$25m. Insiders have been net sellers, collectively disposing of Mex$87m more than they bought in the last 12 months. Aankondiging • Aug 27
Insulet Corporation Announces Omnipod® 5 Automated Insulin Delivery System is now FDA-cleared for People with Type 2 Diabetes Insulet Corporation announced its groundbreaking Omnipod 5 Automated Insulin Delivery System (Omnipod 5) is now indicated for use by people with type 2 diabetes (ages 18 years and older) in the U.S., making it the first and only AID system FDA-cleared for both type 1 and type 2 diabetes management. There are over 30 million people living with type 2 diabetes in the U.S.1, with approximately 6 million people who require insulin,of which 2.5 million are using multiple daily injections (MDI)2. Despite advances in medical therapy over the past 20 years, there has been no significant change in the percentage of adults with type 2 diabetes achieving recommended HbA1c targets3. Only a quarter of individuals with type 2 diabetes on insulin are achieving an HbA1c of 7.0% or less, and half of this population has an HbA1c greater than 8.0%. Despite guideline recommendations for insulin treatment in advanced disease, insulin therapy is often delayed or not appropriately intensified5. Insulet recently presented data showing that Omnipod 5 significantly improves health outcomes while making life easier for people with type 2 diabetes. The SECURE-T2D clinical study demonstrated that compared to prior insulin therapy methods in adults with type 2 diabetes, Omnipod 5 use resulted in considerable reductions in HbA1c: 0.8% overall and 2.1% in those with prior HbA1c 9.0% or higher6. Time in hyperglycemia and total daily insulin dose were also reduced, and there was a 20% improvement in time in range, increasing by 4.8 hours per day, without increasing time in hypoglycemia. The study also demonstrated a clinically meaningful improvement in diabetes distress. The Omnipod 5 System simplifies diabetes management and leads to improved results by eliminating the need for MDI and automatically adjusting insulin delivery every 5 minutes using its advanced SmartAdjust™ technology. As the #1 prescribed and #1 favorite pump7 in the U.S., the waterproof8, discreet, and wearable Omnipod 5 is the first tubeless AID system that communicates with a continuous glucose monitor, proactively correcting for highs and protecting against lows, day and night 9,10. The system is easy to prescribe through the pharmacy and widely covered by many insurance plans, including Medicare Part D. Aankondiging • Jul 09
Insulet Corporation to Report Q2, 2024 Results on Aug 08, 2024 Insulet Corporation announced that they will report Q2, 2024 results After-Market on Aug 08, 2024 Aankondiging • Jun 22
Insulet Corporation Announces SECURE-T2d Pivotal Trial Results Demonstrate Omnipod 5 Improves Clinical Outcomes and Quality of Life in Type 2 Diabetes Insulet Corporation announced positive results from its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) type 2 diabetes pivotal trial at the American Diabetes Association (ADA) 84th Scientific Sessions in Orlando, Florida. This landmark study evaluated the impact of AID in a diverse group of people with type 2 diabetes who require insulin. The SECURE-T2D pivotal trial results showed glycemic improvements with the use of Omnipod 5 compared with prior treatment of insulin injections or pump therapy in adults with type 2 diabetes. The study results showed significant reductions in HbA1c, time in hyperglycemia, and total daily insulin dose, and a large improvement in time in range (TIR), without increasing time in hypoglycemia. The study also demonstrated a clinically meaningful improvement in diabetes distress. Even though over 30 million people live with type 2 diabetes in the United States,1 there are no AID systems currently FDA-cleared for this population. Insulet recently submitted these study results to the FDA for an expansion of Omnipod 5’s indications for use for people with type 2 diabetes and, subject to FDA clearance, expects to commercially launch in the U.S. in early 2025. Omnipod 5 is currently FDA-cleared in the U.S. and C.E. marked for use in those with type 1 diabetes aged two years and older. Key Data Highlights · Mean HbA1c (%) was significantly reduced with Omnipod 5, lowering from 8.2% to 7.4%, or a reduction of 0.8%. Those with a higher baseline HbA1c had a greater decrease: reduction in HbA1c was 2.1% for those with a baseline HbA1c =9.0%. Significant improvements for HbA1c were observed regardless of prior therapy at the start of the trial, including: Multiple daily injections and in those transitioning from basal-only insulin therapy. GLP-1 users and non-GLP-1 users, suggesting that adults with type 2 diabetes who require insulin therapy can greatly benefit from AID regardless of whether they are already using other glucose-lowering medication. Current users or non-users of continuous glucose monitoring (CGM), suggesting an added benefit of AID in type 2 diabetes beyond the glycemic benefit observed with CGM use. Time in range significantly improved with Omnipod 5, increasing by 20%, or 4.8 hours/day, from 45% to 66%. This finding was driven by reductions in hyperglycemia levels including time above 180, 250 and 300 mg/dL. Time below 54 mg/dL (%) and time below 70 mg/dL (%) were shown to be non-inferior (within a 0.5% and 2.0% margin, respectively), demonstrating that improving glycemic control with Omnipod 5 did not increase hypoglycemia risk. Additional outcomes analysis showed that the amount of insulin used was reduced from an average of 0.80 U/kg/day during standard therapy to 0.57 U/kg/day during AID. This corresponds to an average decrease of 23 U/day. As reported by patients through individual surveys (T2-DDAS), there was a significant and clinically meaningful improvement in diabetes distress: the percentage of participants with high diabetes distress (T2-DDAS total score =2.0) was significantly reduced. There were no instances of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic syndrome (HHS). There was one occurrence of severe hypoglycemia during the treatment phase, deemed unrelated to trial device malfunction. There were 13 additional serious adverse events, but none were glycemia-related nor related to the trial device. Aankondiging • Jun 21
Insulet Announces Full Commercial Launch of Omnipod 5 with Expanded Sensor Integrations in the United Kingdom and the Netherlands Insulet Corporation announced that Omnipod 5, compatible with both Dexcom G6 and Abbott FreeStyle Libre 2 Plus continuous glucose monitor (CGM) sensors, is now fully available in the U.K. and the Netherlands for individuals aged two years and older with type 1 diabetes. Omnipod 5 is the first and only tubeless automated insulin delivery (AID) system integrated with both of the leading CGM sensor brands, Dexcom and Abbott FreeStyle Libre. Omnipod 5 is the first tubeless, waterproof AID system with proactive glucose control. The System is designed to be customer-centric and aims to deliver exceptional ease of use. It has demonstrated strong clinical results including lower A1c and improved time in range, while maintaining low time in hypoglycemia. Multiple sensor integrations including Dexcom G6 and Abbott FreeStyle Libre 2 Plus give prescribers greater flexibility when recommending a sensor for their patients and make it simple to begin AID therapy with Omnipod 5. Customers can select the sensor they would like to connect to Omnipod 5 during the setup process. Aankondiging • Apr 10
Insulet Corporation, Annual General Meeting, May 22, 2024 Insulet Corporation, Annual General Meeting, May 22, 2024, at 08:00 US Eastern Standard Time. Agenda: To elect three Class II Directors nominated by the Company's Directors, each to serve for a three-year term and until his or her successor has been duly elected and qualified or until his or her earlier death, resignation or removal; to conduct an advisory vote to approve the compensation of certain executive officers as more fully described in the accompanying proxy statement; to ratify the appointment of Grant Thornton LLP as the Company's independent registered public accounting firm for the fiscal year ending December 31, 2024; and to consider and vote upon such other business as may properly come before the Annual Meeting or any adjournments or postponements thereof. Aankondiging • Apr 04
Insulet Corporation to Report Q1, 2024 Results on May 09, 2024 Insulet Corporation announced that they will report Q1, 2024 results After-Market on May 09, 2024 Aankondiging • Mar 09
Insulet Corporation Presents Positive Results from its First Randomized Controlled Trial (RCT) Showing Improved Glycemic and Patient-Reported Outcomes in Type 1 Diabetes with the Omnipod 5 Automated Insulin Delivery System (Omnipod 5) Insulet Corporation presented positive results from its first randomized controlled trial (RCT) showing improved glycemic and patient-reported outcomes in type 1 diabetes with the Omnipod 5 Automated Insulin Delivery System (Omnipod 5). The OP5-003 Trialresults were presented at the 17thInternational Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Florence, Italy. Professor Eric Renard, MD, PhD of Montpellier University Hospital, shared evidence of the efficacy and safety of the automated Omnipod 5 System compared to insulin pump therapy with continuous glucose monitoring (CGM) in adults with type 1 diabetes (T1D) in the United States and France. Omnipod 5 use led to a 17.5% improvement in time in range (TIR), decreased HbA1c, decreased percentage of time in hypoglycemia, and decreased mean glucose in individuals with baseline HbA1c levels above the recommended target. It is the first Omnipod 5 randomized controlled trial to date, and the first time the system has been evaluated by international participants. Study Overview A key objective of the OP5-003 trial was to evaluate Omnipod 5 in a population that was representative of the real world, primarily participants with an HbA1c above 8% at baseline. Insulet presented data for 194 adults who had used traditional (non-AID) insulin pump therapy (including 87% using the Omnipod or Omnipod DASH Insulin Management System) for three months or longer and had a HbA1c between 7 and 11% (mean 8.5%). The participants had type 1 diabetes for at least one year and were enrolled at 14 institutions across the United States (61%) and France (39%). The participants were randomized into two groups and studied over the course of 13 weeks. The control group (n=62) continued to use their usual insulin pump with a Dexcom G6 CGM, while the intervention group (n=132) used Omnipod 5 with Dexcom G6. Key Data Highlights The participants using Omnipod 5 showed a significantly greater TIR (70-180 mg/dL) by 17.5% (43.8% in Control group versus 61.2% in Intervention group), or an additional 4.2 hours per day, and a greater reduction in HbA1c by 0.58% (1.24% with Omnipod 5 vs. 0.68% in the Control group). The final HbA1c was 7.25% in the Omnipod 5 group versus 7.84% in the Control group. Significantly lower mean glucose and time above 180 mg/dL (%) were also observed in the Omnipod 5 group versus the Control group. Time spent below 70 mg/dL (%) was significantly lower with Omnipod 5 by 0.36%, with mean time below 70 mg/dL (%) decreasing from 1.66% to 1.18% with Omnipod 5, while it increased from 1.66% to 1.75% in the Control group. Time below 54 mg/dL (%) was shown to be non-inferior (within a 1% margin) between the two groups. This mean value decreased from 0.32% to 0.23% with Omnipod 5 and decreased from 0.42% to 0.37% in the Control group. There were zero events of severe hypoglycemia or DKA with Omnipod 5, and one event of severe hypoglycemia and zero events of DKA in the Control group. All of the primary and secondary endpoints of the study were met. Exploratory endpoints showed no significant difference in change in total daily dose from baseline or change in body mass index from baseline between the Omnipod 5 and Control groups. Insulet also presented positive patient-reported results related to three key psychosocial measures that were included as secondary endpoints: diabetes distress, hypoglycemia confidence, and diabetes-related quality of life. As reported by study participants through individual surveys, Omnipod 5 use resulted in both statistically significant and clinically meaningful improvements in each of these three measures compared to the Control group. These results demonstrate that Omnipod 5 provides clinically meaningful improvements in key psychosocial aspects of living with type 1 diabetes. In conclusion, this multi-national, RCT data demonstrates the superiority of the Omnipod 5 AID System compared to standard pump therapy with CGM and indicates that it should be offered as a first-line therapy for adults with type 1 diabetes. These results will be submitted for publication later this year. Aankondiging • Mar 06
Insulet Corporation to Present Results from First Omnipod® 5 Randomized Controlled Trial (OP5-003) at the 17Th International Conference on Advanced Technologies & Treatments for Diabetes Insulet Corporation will present new clinical evidence related to the Omnipod 5 Automated Insulin Delivery System (Omnipod 5) at the 17thInternational Conference on Advanced Technologies & Treatments for Diabetes (ATTD) taking place March 6 - 9, 2024 in Florence, Italy, and online. With data on more than 100,000 users in the U.S. now available, Dr. Gibb and others will share new insights, including outcomes for those using the system for more than one year, data on users with low insulin requirements, and how the system responds to a missed meal bolus in the real world. An earlier analysis of the Real-World Evidence database as of July 2023 was recently published in Diabetes Technology and Therapeutics. The paper presents the larger published U.S. dataset in the current AID landscape and demonstrates positive clinical outcomes under real-world conditions across a diverse population, including prior pump and MDI users, those on Medicare and Medicaid, and across all age groups greater than two years. Users at an average target of 110 mg/dL achieved nearly 70% Time in Range while maintaining very low rates of hypoglycemia. Chaired by Dr. Ly, the symposium will focus on Omnipod 5 and the importance of AID technology as standard of care for people with diabetes. Clinical evidence from Insulet's Omnipod 5 Real-World Evidence database and results from the Company's EVOLUTION Study (the first feasibility study of Insulet's work to advance their AID algorithm) will be presented. Dr. Ly will also provide a Company update on future product innovations. speakers will include: Dr. Paolo di Bartolo, Chief of Ravenna Diabetes Center at the Romagna Local Health Authority in Italy. Prof. May Ng, OBE Honorary Professor, Consultant Pediatric Endocrinologist at Mersey West Lancashire teaching Hospitals, Edge Hill University and University of Liverpool in the United Kingdom. Dr. Martin de Bock, Associate Professor and Pediatric Endocrinologist at the University of Otago, Christchurch in New Zealand. Reported Earnings • Feb 26
Full year 2023 earnings released: EPS: US$2.96 (vs US$0.066 in FY 2022) Full year 2023 results: EPS: US$2.96 (up from US$0.066 in FY 2022). Revenue: US$1.70b (up 30% from FY 2022). Net income: US$206.3m (up US$201.7m from FY 2022). Profit margin: 12% (up from 0.4% in FY 2022). The increase in margin was driven by higher revenue. Revenue is forecast to grow 14% p.a. on average during the next 3 years, compared to a 8.7% growth forecast for the Global Medical Equipment industry. Aankondiging • Feb 23
Insulet Corporation Provides Unaudited Revenue Guidance for the Quarter Ending March 31, 2024 and Full Year Ending December 31, 2024 Insulet Corporation provided unaudited revenue guidance for the quarter ending March 31, 2024 and full year ending December 31, 2024. For the quarter, the company expects total GAAP revenue growth to be between 17% to 20%.For the full year, the company expects total GAAP revenue growth to be between 12% to 17%. Aankondiging • Jan 19
Insulet Corporation Announces Board Changes Insulet Corporation announced the following appointments to the Company’s Board of Directors, effective January 18, 2023: Flavia Pease, Corporate Executive Vice President and Chief Financial Officer at Charles River Laboratories and Timothy Stonesifer, Chief Financial Officer at Alcon Inc. In addition, the Company announced Shacey Petrovic and Corinne Nevinny will retire from the Board during the Company’s 2024 Annual Meeting in May 2024. Ms. Pease has extensive industry expertise and has managed finance organizations of expanding, large-scale businesses. She joined Charles River in 2022 as Corporate Executive Vice President and Chief Financial Officer where she leads the Finance and Procurement Functions. Prior to joining Charles River, Ms. Pease served in a variety of leadership roles at Johnson & Johnson over her 23-year tenure, including Vice President and Group Chief Financial Officer of Johnson & Johnson’s global Medical Devices business, and Vice President, Finance for Janssen North America. Ms. Pease holds a Bachelor of Science in Economics from the Pontifícia Universidade Católica in Rio de Janeiro, Brazil, and a Master of Business Administration from Santa Clara University. Mr. Stonesifer is a seasoned executive with over 30 years of global financial and operational experience. He has been the Chief Financial Officer at Alcon Inc. since April 2019. Prior to joining Alcon, he served as Executive Vice President and Chief Financial Officer at Hewlett Packard Enterprise (HPE) from November 2015 through September 2018. Before joining HPE, he served as Chief Financial Officer of General Motors’ International Operations from 2011 to 2014. Earlier in his career, Mr. Stonesifer served in a number of chief financial officer roles at divisions of General Electric during his 21-year tenure. Mr. Stonesifer holds a Bachelor of Arts in Economics from the University of Michigan. Ms. Petrovic, who has nearly six years of distinguished Board service, joined Insulet in 2015 as Chief Commercial Officer and served as President and Chief Executive Officer for over three years. Ms. Nevinny is retiring from the Board after five years of distinguished service. Aankondiging • Jan 12
Insulet Corporation to Report Q4, 2023 Results on Feb 22, 2024 Insulet Corporation announced that they will report Q4, 2023 results at 4:00 PM, US Eastern Standard Time on Feb 22, 2024 Recent Insider Transactions • Nov 17
Director & Advisor recently sold Mex$43m worth of stock On the 13th of November, Shacey Petrovic sold around 15k shares on-market at roughly Mex$2,891 per share. This transaction amounted to 26% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of Mex$44m more than they bought in the last 12 months. Reported Earnings • Nov 04
Third quarter 2023 earnings released: EPS: US$0.74 (vs US$0.075 loss in 3Q 2022) Third quarter 2023 results: EPS: US$0.74 (up from US$0.075 loss in 3Q 2022). Revenue: US$432.7m (up 27% from 3Q 2022). Net income: US$51.9m (up US$57.1m from 3Q 2022). Profit margin: 12% (up from net loss in 3Q 2022). Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 9.0% growth forecast for the Global Medical Equipment industry. Aankondiging • Nov 03
Insulet Corporation Provides Revenue Guidance for the Fourth Quarter and Year Ending December 31, 2023 Insulet Corporation provided revenue guidance for the fourth quarter and year ending December 31, 2023. For the quarter ending December 31, 2023, the Company expects revenue growth of 22% to 25%. For the year ending December 31, 2023, the Company is raising its expected revenue growth to a range of 26% to 27% (previously 22% to 25%). Aankondiging • Oct 24
Insulet Announces FDA 510(k) Clearance of the Omnipod® 5 App for iPhone Insulet Corporation announced it has received FDA 510(k) clearance for the Omnipod 5 App for iPhone, making Insulet the first and only company to offer a tubeless automated insulin delivery (AID) system with full control from a compatible Android and iOS smartphone. Since its full commercial launch in August 2022 in the United States, the Omnipod 5 Automated Insulin Delivery System (Omnipod 5) has included the option for smartphone control for customers using compatible Android devices. With today’s announcement, the Omnipod 5 Pod will soon be controllable from a compatible iPhone, providing even more options for users who prefer not to carry an extra device. Designed with users in mind, the Omnipod 5 App for iPhone offers the same functionality as the Omnipod 5 App for Android, plus additional capabilities, and an intuitive design. Users will have access to a new custom foods feature with the ability to save carbohydrate data for favorite foods, snacks, or meals that are consumed frequently. The Omnipod 5 App for iPhone will launch first with the Dexcom G6 Continuous Glucose Monitoring System integration, with a full market release in 2024. Users of the Omnipod 5 System can download the iPhone App free of charge once available. People with type 1 diabetes who are interested in Omnipod 5 should contact their healthcare providers to learn how to get started on the system today. The Omnipod 5 App for iPhone will be a simple transition for those with compatible devices once available. Insulet will inform the diabetes community of the release timing closer to the date. To stay informed of Insulet’s progress with future innovation, visit Omnipod.com/innovation. Aankondiging • Sep 29
Insulet Corporation to Report Q3, 2023 Results on Nov 02, 2023 Insulet Corporation announced that they will report Q3, 2023 results After-Market on Nov 02, 2023 Aankondiging • Aug 29
Insulet Announces Full Market Release of Omnipod 5 Automated Insulin Delivery System in Germany Insulet Corporation announced the commercial launch of its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes (T1D) in its third market, Germany. Omnipod 5 is also available in the U.S. and the U.K. Omnipod 5 is the first CE marked tubeless automated insulin delivery (also known as hybrid closed loop) system that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System. The system1 includes the tubeless Pod enhanced with SmartAdjust™ technology and a handheld Controller integrated with the SmartBolus Calculator. The system is interoperable with Dexcom G6 for automated insulin delivery to help protect against high and low glucose levels 2. Insulet has presented real-world data from 36,634 adults3 and 18,516 children and adolescents4 with type 1 diabetes in the U.S. demonstrating that the highly favorable glycemic outcomes first reported in Omnipod 5 pivotal trials are achievable among Omnipod 5 users of all ages in the real world. Reported Earnings • Aug 09
Second quarter 2023 earnings released: EPS: US$0.39 (vs US$0.51 loss in 2Q 2022) Second quarter 2023 results: EPS: US$0.39 (up from US$0.51 loss in 2Q 2022). Revenue: US$396.5m (up 32% from 2Q 2022). Net income: US$27.3m (up US$62.3m from 2Q 2022). Profit margin: 6.9% (up from net loss in 2Q 2022). Revenue is forecast to grow 15% p.a. on average during the next 3 years, compared to a 8.8% growth forecast for the Global Medical Equipment industry. Recent Insider Transactions • Jul 12
Executive VP recently sold Mex$6.7m worth of stock On the 3rd of July, Wayde McMillan sold around 1k shares on-market at roughly Mex$4,826 per share. This transaction amounted to 7.7% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Wayde has been a net seller over the last 12 months, reducing personal holdings by Mex$14m. Aankondiging • Jul 06
Insulet Corporation to Report Q2, 2023 Results on Aug 08, 2023 Insulet Corporation announced that they will report Q2, 2023 results After-Market on Aug 08, 2023 Aankondiging • Jun 21
Insulet Corporation Announces Omnipod 5 Automated Insulin Delivery System Is Now Available in the United Kingdom Insulet Corporation announced the commercial launch of its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes (T1D) in the United Kingdom (UK). The Omnipod 5 System is where simplicity meets advanced technology. Omnipod 5 is the first CE marked tubeless hybrid closed loop system (also known as automated insulin delivery) that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System to automatically adjust insulin delivery and help protect against high and low glucose levels1. The system2 consists of the tubeless Pod enhanced with SmartAdjust™? technology and the Omnipod 5 Controller with its integrated SmartBolus Calculator. The system is interoperable with the Dexcom G6 CGM for automated insulin delivery. Every five minutes, SmartAdjust technology receives a CGM value and trend, and predicts where glucose will be 60 minutes into the future. The system then increases, decreases, or paused insulin delivery based on the user's desired and customized glucose target. Omnipod 5 simplifies daily diabetes management by making many of these dosing decisions for the user, while they focus on other aspects of their life. Lydia Parkhurst, a 26-year-old geography teacher who enjoys backpacking and has travelled the world with her Omnipod DASH®? System, has been a Podder since 2015. Insulet is working in partnership with the National Health Service (NHS) at all levels to ensure access to Omnipod 5 for people with type 1 diabetes. Insulet plans to release Omnipod 5 in Germany in the fall of 2023. To learn more about Omnipod 5, visit the Omnipod website. Study in 240 people with T1D aged 6 to 70 years involving two weeks standard diabetes therapy followed by three months Omnipod 5 use in Automated Mode. Recent Insider Transactions • Jun 10
Insider recently sold Mex$2.5m worth of stock On the 5th of June, Luciana Borio sold around 500 shares on-market at roughly Mex$4,948 per share. This transaction amounted to 33% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth Mex$7.2m. Insiders have been net sellers, collectively disposing of Mex$25m more than they bought in the last 12 months. Recent Insider Transactions • May 26
Insider recently bought Mex$18m worth of stock On the 23rd of May, Michael Minogue bought around 3k shares on-market at roughly Mex$5,477 per share. This transaction amounted to 33% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Despite this recent purchase, insiders have collectively sold Mex$48m more in shares than they bought in the last 12 months. Aankondiging • Jan 13
Insulet Corporation to Report Q4, 2022 Results on Feb 23, 2023 Insulet Corporation announced that they will report Q4, 2022 results at 4:00 PM, US Eastern Standard Time on Feb 23, 2023 Recent Insider Transactions • Nov 23
Executive VP & Chief Commercial Officer recently sold Mex$17m worth of stock On the 18th of November, Bret Christensen sold around 3k shares on-market at roughly Mex$5,750 per share. This transaction amounted to 19% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of Mex$59m more than they bought in the last 12 months. Recent Insider Transactions • Jun 09
Executive VP & COO recently sold Mex$25m worth of stock On the 6th of June, Charles Alpuche sold around 6k shares on-market at roughly Mex$4,217 per share. This was the largest sale by an insider in the last 3 months. Charles has been a seller over the last 12 months, reducing personal holdings by Mex$49m. 
