US Market News
7日前
Tandem Diabetes Care Automated Insulin Delivery Systems Receive CE Mark for Type 2 Diabetes and Type 1 Diabetes During PregnancyJune 5, 2026 8:30 AM
Business Wire Tandem Diabetes Care, Inc. (Nasdaq: TNDM), a leading insulin delivery and diabetes technology company, today announced receipt of CE mark for expanded indications of its automated insulin delivery (AID) systems in Europe. The t:slim X2 and Tandem Mobi insulin delivery systems running Control-IQ+ AID technology are now approved for use by people with type 1 diabetes during pregnancy and adults with type 2 diabetes. “These expanded indications underscore the strength of our portfolio and our commitment to bringing innovative diabetes technology to more people worldwide,” said John Sheridan, president and chief executive officer. “By expanding access to our AID technology, we’re broadening our impact and advancing our mission to improve lives across the diabetes community.” Pregnancy in Type 1 Diabetes This expanded label indication for use in type 1 diabetes during pregnancy is based on results from the CIRCUIT trial published in Journal of the American Medical Association (JAMA) in October 2025.1 Participants in this multi-center, randomized controlled trial were assigned to use a t:slim X2 insulin pump with Control-IQ technology or to continue their multiple daily insulin injections or insulin pump with continuous glucose monitoring. The Control-IQ group experienced 12.6% more time in the pregnancy glucose target range 3.5-7.8 mmol/L (63-140 mg/dL), approximately 3 hours more per day, compared to those using their standard therapy, from 16 weeks gestation to the end of pregnancy. Data from the CIRCUIT Trial will be presented this weekend during a product theater at the 2026 Scientific Sessions of the American Diabetes Association in New Orleans, Louisiana. The presentation takes place on Saturday, June 6 from 10:15 am to 11:00 am Central Time in Product Theater #1. Adults with Type 2 Diabetes “The benefits of Control-IQ+ technology were evident across an incredibly diverse population of people with type 2 diabetes, regardless of pre-study glycemic control or experience with diabetes technology,” said Jordan Pinsker, MD, chief medical officer. This expanded label indication for adults with type 2 diabetes is based on strong clinical evidence from the first large-scale, randomized, controlled study of an automated insulin delivery system in type 2 diabetes (the 2IQP trial), completed in more than 300 people with type 2 diabetes, and published in the New England Journal of Medicine in March 2025.2 The trial compared use of a t:slim X2 pump with Control-IQ+ technology to a control group who continued their existing insulin regimen. Both groups used a Dexcom G6 Continuous Glucose Monitoring (CGM) System for the duration of the study. In the pivotal study, people using Control-IQ+ achieved a 0.9% reduction in A1C, compared with 0.3% in the control group, with those entering the study at A1C levels of 9% or higher seeing a 2.3% reduction. The technology was shown to be safe, with low rates of hypoglycemia, no new safety signals identified, and no diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome events reported. About Tandem Diabetes Care Automated Insulin Delivery Systems Tandem Diabetes Care manufactures the t:slim X2, the all-in-one insulin delivery system for convenient diabetes management, and the Tandem Mobi, the world's smallest durable AID system. Both systems are powered by Control-IQ+ AID technology to provide proven, best-in-class outcomes. Results from major studies in type 1 and type 2 diabetes, including those published by the New England Journal of Medicine (October 2019, August 2020, March 2023, and March 2025), show immediate and sustained glycemic improvements, including more time in range and improved sleep. The t:slim X2 insulin pump is currently available in several European countries. The Tandem Mobi system is expected to begin launching in select countries in the second half of 2026. For more information, visit tandemdiabetes.com. About Tandem Diabetes Care, Inc. Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company’s pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ+ advanced hybrid closed-loop technology. Tandem Diabetes Care is based in San Diego, California. For more information, visit tandemdiabetes.com. Follow @TandemDiabetesCare on TikTok and @TandemDiabetes on Facebook, Instagram, LinkedIn, and X. Forward-looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, Tandem’s expected timeline and ability to launch the Tandem Mobi system in select European countries. These and other risks are identified and described in greater detail under the “Risk Factors” heading of our most recent Annual Report on Form 10-K. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Actual results could differ materially from those anticipated or projected in the forward-looking statements. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events, or other factors. Important Safety Information The t:slim X2 insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices. The pump is indicated for the management of Type 1 diabetes mellitus in persons 2 years of age and greater who require a total daily insulin dose of at least 5 units and who weigh at least 9 kilograms, and of Type 2 diabetes mellitus in persons 18 years of age and greater. The pump is intended for use in pregnancy complicated by Type 1 diabetes mellitus, provided the linked CGM system is suitable for use in pregnancy. The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices. The pump is intended for single patient use. The pump is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater who require a total daily insulin dose of at least 5 units and who weigh at least 9 kilograms, and of Type 2 diabetes mellitus in persons 18 years of age and greater. The pump is intended for use in pregnancy complicated by Type 1 diabetes mellitus, provided the linked CGM system is suitable for use in pregnancy. Control-IQ+ technology is intended for use with a compatible continuous glucose monitor (CGM) and a Tandem insulin pump to automatically increase, decrease, and suspend delivery of basal insulin based on CGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. WARNING: Control-IQ+ should not be used in anyone under the age of 2 years old with Type 1 diabetes or under the age of 18 years old with Type 2 diabetes. It should also not be used in patients who require less than a total daily insulin dose of 5 units of insulin per day or who weigh less than 20 pounds (9 kilograms), as those are the required minimum values needed for Control-IQ+ to operate safely. Users of the pump and Control-IQ+ must: use the insulin pump, iCGM, and all other system components in accordance with their respective instructions for use. Failure to follow these instructions for use could result in an over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events. Visit tandemdiabetes.com/safetyinfo for additional important safety information. ©2026 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, the Tandem logo, Control-IQ+, Tandem Mobi and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. All third-party marks are the property of their respective owners. ____________________________ 1 Donovan LE, Lemieux P, Dunlop AD, et al. Closed-Loop Insulin Delivery in Type 1 Diabetes in Pregnancy: The CIRCUIT Randomized Clinical Trial. JAMA. 2025;334(24):2176-2185. doi:10.1001/jama.2025.19578
2 Kudva YC, Raghinaru D, Lum JW, et al. A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes. N Engl J Med. 2025; 393(6):617-618. doi: 10.1056/NEJMc2507995. View source version on businesswire.com: https://www.businesswire.com/news/home/20260605572579/en/ Media Contact:
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IR@tandemdiabetes.com Original: Tandem Diabetes Care Automated Insulin Delivery Systems Receive CE Mark for Type 2 Diabetes and Type 1 Diabetes During Pregnancy
US Market News
1月前
Tandem Diabetes Care Announces First Quarter 2026 Financial ResultsMay 7, 2026 4:05 PM
Business Wire Tandem Diabetes Care, Inc. (Nasdaq: TNDM), a global insulin delivery and diabetes technology company, today reported its financial results for the quarter ended March 31, 2026 and reaffirmed financial guidance for the year ending December 31, 2026. First Quarter 2026 Financial and Strategic Highlights Achieved record first quarter pump shipments, sales and gross margin: Shipments of more than 29,000 pumps worldwide, including 19,000 pumps in the United States Sales of $247.2 million worldwide, including $160.8 million in the United States Gross margin of 55%, up 480 basis points compared to first quarter 2025 Launched pay-as-you-go reimbursement model in the United States pharmacy channel Expanded Tandem Mobi connected care ecosystem by adding Android compatibility Demonstrated positive free cash flow and further reinforced balance sheet by closing a 0.00% convertible debt offering “In the first quarter, we delivered on our financial plan while initiating key operational steps to advance our strategic priorities,” said John Sheridan, president and chief executive officer. “Our 2026 goals are firmly in focus, and we are committed to providing innovative, best-in-class diabetes technology to our customers in more efficient and cost-effective ways, while strengthening our global business model and building long-term value for shareholders.” First Quarter 2026 Financial Results Compared to First Quarter 2025 Sales: Worldwide sales increased 5% to $247.2 million, compared to $234.4 million. Sales increased 2% in constant currency(1). Sales in the United States increased 7% to $160.8 million, compared to $150.6 million. International sales increased 3% to $86.4 million compared to $83.8 million. Sales decreased 5% in constant currency(1). Shipments in the United States were more than 19,000 pumps. International shipments were more than 10,000 pumps. Gross profit: Gross profit was $136.8 million, compared to $118.4 million. Gross margin was 55%, compared to 51%. Operating loss: GAAP and non-GAAP operating loss(2) was $17.4 million, or negative 7% of sales, compared to GAAP operating loss of $120.9 million, or negative 52% of sales and non-GAAP operating loss(2) of $109.7 million or negative 47% of sales, in the first quarter of 2025. The first quarter 2025 included a $75.2 million charge for acquired in-process research and development expenses (“IPR&D”). Net income (loss): GAAP and non-GAAP net loss(2) was $20.4 million, compared to GAAP net loss of $130.6 million and non-GAAP net loss(2) of $119.4 million, in the first quarter 2025. Adjusted EBITDA(2) was $2.7 million, or 1% of sales, compared to negative $79.9 million, or negative 34% of sales. (1) Constant currency sales growth is a non-GAAP measure that represents the change in sales between current and prior year periods using the exchange rate in effect during the applicable prior year period. The Company presents constant currency growth because management believes it provides meaningful information regarding the Company’s results on a consistent and comparable basis. The Company uses this non-GAAP measure to evaluate operating results. A reconciliation of constant currency to GAAP sales can be found in Table C “Sales by Geography and Non-GAAP Reconciliation of Constant Currency Sales Growth” attached to this press release. Also see “Non-GAAP Financial Measures” below for additional information. (2) A reconciliation of non-GAAP financial measures to their most directly comparable GAAP financial measures and additional information can be found in Table D “Reconciliation of GAAP versus Non-GAAP Financial Results” attached to this press release. Also see “Non-GAAP Financial Measures” below for additional information. See tables for additional financial information. 2026 Financial Guidance For the year ending December 31, 2026, the Company is reaffirming its financial guidance as follows: Sales are estimated to be approximately $1.065 billion to $1.085 billion United States sales of approximately $730 million to $745 million International sales of approximately $335 million to $340 million Gross margin is estimated to be approximately 56% to 57% of sales Adjusted EBITDA(3) margin is estimated to be approximately 5% to 6% of sales Non-cash charges included in cost of goods sold and operating expenses are estimated to be approximately $100 million. This includes: Approximately $80 million non-cash, stock-based compensation expense Approximately $20 million depreciation and amortization expense For a comprehensive overview of the Company's guidance assumptions for 2026, including pricing and transition assumptions for the adoption of pay-as-you go reimbursement in the United States and the initiation of international direct operations, please see the Events & Presentations tab in the Investor Center of the Tandem Diabetes Care website at https://investor.tandemdiabetes.com. (3) Adjusted EBITDA margin is a non-GAAP financial measure. The Company has not reconciled adjusted EBITDA margin outlook to the most comparable GAAP outlook because it is not possible to do so without unreasonable efforts due to the uncertainty and potential variability of reconciling items, which are dependent on future events and often outside of management’s control and which could be significant. Because such items cannot reasonably be predicted with the level of precision required, the Company is unable to provide outlook for the comparable GAAP measure (net income (loss) as a percentage of sales). Forward-looking estimates of adjusted EBITDA margin are made in a manner consistent with relevant calculations and assumptions noted herein. Non-GAAP Financial Measures Certain non-GAAP financial measures are presented in this press release to provide information that may assist investors in understanding the Company’s financial results and assessing its prospects for future performance. The Company believes these non-GAAP financial measures are important operating performance indicators because they either exclude items that are unrelated to, and may not be indicative of, the Company’s core operating results, or aid in presenting information on a consistent and comparable basis. These non-GAAP financial measures, as calculated, may not necessarily be comparable to similarly titled measures of other companies and may not be appropriate measures for comparing the performance of other companies relative to the Company. These non-GAAP financial results are not intended to represent, and should not be considered to be more meaningful measures than, or alternatives to, measures of operating performance as determined in accordance with GAAP. To the extent the Company uses such non-GAAP financial measures in the future, we expect they will be calculated using a consistent method from period to period and, if not, an explanation will be provided. A reconciliation of each of the historical GAAP financial measures to the most directly comparable historical non-GAAP financial measures has been provided in Table C “Sales by Geography and Non-GAAP Reconciliation of Constant Currency Sales Growth” and Table D “Reconciliation of GAAP versus Non-GAAP Financial Results” attached to this press release. In the first quarter of 2025, the Company included an adjustment for acquired IPR&D expense in its non-GAAP financials. Beginning in the second quarter of 2025, the Company no longer included an adjustment for IPR&D expense in its non-GAAP results to align with views expressed by the staff of the U.S. Securities and Exchange Commission. Conference Call The Company will hold a conference call and simultaneous webcast today at 4:30pm Eastern Time (1:30pm Pacific Time). The link to the webcast will be available by accessing the Events & Presentations tab in the Investor Center of the Tandem Diabetes Care website at http://investor.tandemdiabetes.com, and will be archived for 30 days. To access the call by phone, please use this link (https://register-conf.media-server.com/register/BI870b8c6fdaae4b6d982fb59187bc9470) and you will be provided with dial-in details, including a personal pin. About Tandem Diabetes Care, Inc. Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company’s pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ+ advanced hybrid closed-loop technology. Tandem Diabetes Care is headquartered in San Diego, California. For more information, visit tandemdiabetes.com. Tandem Diabetes Care, the Tandem logo, Control-IQ, Control-IQ+, Tandem Mobi and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements include statements regarding, among other things, the Company’s projected financial results, the expected benefits of our multichannel strategy, the anticipated sales growth, and the ability to achieve other operational and commercial goals. The Company’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, the Company’s ability to achieve projected financial results will be impacted by market acceptance of the Company’s products; products marketed and sold or under development by competitors; foreign currency exchange rates; the Company’s ability to establish and sustain operations to support international sales, including expanding into additional geographies; changes in reimbursement rates or insurance coverage for the Company’s products; the Company’s ability to meet increasing operational and infrastructure requirements from higher customer interest and a larger base of existing customers; the Company’s ability to successfully commercialize its products; the Company’s ability to develop and launch new products; risks associated with the regulatory approval process internationally for new products; the potential that newer products, or other technological breakthroughs for the monitoring, treatment or prevention of diabetes, may render the Company’s products obsolete or less desirable, or may otherwise negatively impact the purchasing trends of customers; reliance on third-party relationships, such as outsourcing and supplier arrangements; global economic conditions; and other risks identified in the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, and other documents that the Company files with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events or other factors. TANDEM DIABETES CARE, INC. CONDENSED CONSOLIDATED BALANCE SHEETS Table A (in thousands) (unaudited) March 31, December 31, 2026 2025 Assets Current assets: Cash, cash equivalents and short-term investments $ 570,256 $ 292,666 Accounts receivable, net 140,672 165,491 Inventories 126,400 128,769 Other current assets 49,772 31,217 Total current assets 887,100 618,143 Property and equipment, net 83,250 83,580 Operating lease right-of-use assets 95,740 96,172 Equity method investment 56,486 60,351 Other long-term assets 30,818 22,866 Total assets $ 1,153,394 $ 881,112 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable, accrued expenses and employee-related liabilities $ 134,793 $ 138,488 Operating lease liabilities 20,109 19,472 Deferred revenue 8,954 9,527 Other current liabilities 84,103 75,237 Total current liabilities 247,959 242,724 Convertible senior notes, net - long-term 601,768 310,036 Operating lease liabilities - long-term 112,858 114,967 Deferred revenue - long-term 7,994 8,474 Other long-term liabilities 50,412 49,741 Total liabilities 1,020,991 725,942 Total stockholders’ equity 132,403 155,170 Total liabilities and stockholders’ equity $ 1,153,394 $ 881,112 TANDEM DIABETES CARE, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Table B (in thousands, except per share data) (Unaudited) Three Months Ended March 31, 2026 2025 Sales $ 247,221 $ 234,422 Cost of sales 110,433 116,015 Gross profit 136,788 118,407 Operating expenses: Selling, general and administrative 108,187 113,853 Research and development 46,035 50,215 Acquired in-process research and development expenses — 75,217 Total operating expenses 154,222 239,285 Operating loss (17,434 ) (120,878 ) Total other income (expense), net (2,443 ) (1,211 ) Loss before income taxes (19,877 ) (122,089 ) Income tax expense 516 8,467 Net loss $ (20,393 ) $ (130,556 ) Net loss per share - basic and diluted $ (0.30 ) $ (1.97 ) Weighted average shares used to compute basic and diluted net loss per share 68,397 66,404 TANDEM DIABETES CARE, INC. SALES BY GEOGRAPHY AND NON-GAAP RECONCILIATION OF CONSTANT CURRENCY SALES GROWTH Table C (Unaudited) ($'s in thousands) Three Months Ended March 31, 2026 2025 % Change Currency Impact % Change Constant Currency United States: Pump $ 77,941 $ 72,141 8 % Supplies and other 82,902 78,491 6 % Total Sales in the United States $ 160,843 $ 150,632 7 % — % 7 % International: Pump $ 32,485 $ 29,950 8 % Supplies and other 53,893 53,840 — % Total International Sales $ 86,378 $ 83,790 3 % 8 % (5 )% Total Worldwide Sales(1) $ 247,221 $ 234,422 5 % 3 % 2 % (1) Constant currency sales growth is a non-GAAP measure that represents the change in sales between current and prior year periods using the exchange rate in effect during the applicable prior year period. The Company presents constant currency growth because management believes it provides meaningful information regarding the Company’s results on a consistent and comparable basis. The Company uses this non-GAAP measure to evaluate the Company’s operating results. TANDEM DIABETES CARE, INC. RECONCILIATION OF GAAP VERSUS NON-GAAP FINANCIAL RESULTS Table D (Unaudited) ($'s in thousands) Three Months Ended March 31, 2026 2025 GAAP operating loss $ (17,434 ) $ (120,878 ) Non-recurring facility impairment and restructuring costs(1) — 11,167 Non-GAAP operating loss $ (17,434 ) $ (109,711 ) GAAP operating margin(2) (7 )% (52 )% Non-GAAP operating margin(2) (7 )% (47 )% GAAP net loss $ (20,393 ) $ (130,556 ) Income tax expense 516 8,467 Interest income, interest expense and other, net 2,443 1,211 Depreciation and amortization 4,504 4,311 Stock-based compensation expense 15,660 25,489 Non-recurring facility impairment and restructuring costs(1) — 11,167 Adjusted EBITDA $ 2,730 $ (79,911 ) Adjusted EBITDA margin(2) 1 % (34 )% GAAP net loss $ (20,393 ) $ (130,556 ) Non-recurring facility impairment and restructuring costs(1) — 11,167 Non-GAAP net loss $ (20,393 ) $ (119,389 ) GAAP cash provided by (used in) operating activities $ 11,054 $ (18,278 ) Less: capital expenditures (6,268 ) (2,965 ) Non-GAAP free cash flow (3) $ 4,786 $ (21,243 ) (1) In the first quarter of 2025, the Company recorded $11.2 million in impairment charges related to its operating lease right-of-use assets, and severance and other restructuring costs associated with the relocation of certain research and development activities. (2) GAAP margins, including GAAP gross margin and GAAP operating margin, and non-GAAP margins, including non-GAAP operating margin and adjusted EBITDA margin, are calculated using GAAP sales. (3) Free Cash Flow is a non-GAAP financial measure that we define as cash provided by operating activities less capital expenditures. View source version on businesswire.com: https://www.businesswire.com/news/home/20260507413709/en/ Media Contact:
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IR@tandemdiabetes.com Original: Tandem Diabetes Care Announces First Quarter 2026 Financial Results
US Market News
3月前
Tandem Mobi Now Compatible with Android SmartphonesMarch 4, 2026 5:00 PM
Business Wire
Tandem Diabetes Care expands connected-care ecosystem by adding Android platform
Tandem Diabetes Care, Inc. (Nasdaq: TNDM), a global insulin delivery and diabetes technology company, today announced that Tandem Mobi, the world’s smallest, durable automated insulin delivery system,1 can now be used with compatible Android smartphones in the U.S. via the Tandem Mobi mobile app.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260304073769/en/Tandem Mobi Now Compatible with Android Smartphones in U.S.
"By expanding to Android, we’re broadening our reach to bring the benefits of Tandem Mobi to even more people living with diabetes," said John Sheridan, president and chief executive officer. "It's an exciting milestone that underscores our commitment to delivering choice in diabetes technology, enabling more people to experience the convenience and flexibility that Tandem Mobi provides.”
Tandem Mobi, the tiny pump with big control, is powered by the Control-IQ+ technology predictive algorithm. Demonstrated benefits of Control-IQ+ include:
Day 1 improvements2†
79% time in range3‡
90% overnight time in range4†
Launched with compatible iPhone models in 2024, Tandem Mobi combines best-in-class outcomes with enhanced wearability. The pump is small enough for users to wear on-body with an adhesive sleeve (sold separately), clip discreetly to their clothing, or slip into the coin pocket of their pants.
The Tandem Mobi mobile app is a secure, user-friendly mobile application designed to seamlessly pair with Tandem Mobi. It enables users to manage their diabetes directly from their personal, compatible smartphone, which now includes Android devices. The app’s intuitive interface and secure connectivity to the Tandem Source platform helps support better engagement between patients and their healthcare providers, facilitating more informed treatment decisions and improved outcomes. The U.S. Food and Drug Administration cleared the Android version of the Tandem Mobi mobile app in November 2025, which was followed by a limited release in December 2025.
The Tandem Mobi mobile app is downloadable from Google Play for compatible smartphones, including Google Pixel models 6 through 10 and Samsung Galaxy models S21 through S25.
To learn more about this expanded Tandem Mobi offering, please visit:
https://www.tandemdiabetes.com/TandemMobiAndroid
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company’s pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ+ advanced hybrid closed-loop technology. Tandem Diabetes Care is based in San Diego, California. For more information, visit tandemdiabetes.com.
Follow @TandemDiabetesCare on TikTok and @TandemDiabetes on Facebook, Instagram, LinkedIn, and X.
†Studies were conducted using a t:slim X2 insulin pump with Control-IQ technology and a Dexcom G6 sensor. ‡ With optimized Correction Factor based on “rule of less than 1600.”
References
As of Jan., 2026. Data on file, Tandem Diabetes Care.
Beck RW, et al. Diabetes Technol Ther. 2023;25(5):329-342.
Messer LH, Breton M. Diabetes Technol Ther. 2023;25(12):877-882.
Breton MD, Kovatchev BP. Diabetes Technol Ther. 2021;23(9):601-608.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, the anticipated timing for the availability of the Tandem Mobi Android mobile application as well as our ability to provide the Tandem Mobi Android mobile application on the Google Play Store. These statements are subject to numerous risks and uncertainties, including our ability to continue to offer the Tandem Mobi mobile application on the Google Play Store. These and other risks are identified and described in greater detail under the “Risk Factors” heading of our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other documents filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Actual results could differ materially from those anticipated or projected in the forward-looking statements. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events, or other factors.
Important Safety Information
RX ONLY. The Tandem Mobi insulin pump with interoperable technology (the pump) and Control-IQ+ technology (Control-IQ+) are intended for single patient use. The pump and Control-IQ+ are indicated for use with NovoLog or Humalog U-100 insulin. Tandem Mobi system: The Tandem Mobi insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is indicated for use in persons 2 years of age and greater. Control-IQ+ technology: Control-IQ+ technology is intended for use with compatible integrated continuous glucose monitors (iCGM, sold separately) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.
WARNING: Control-IQ+ technology should not be used in anyone under the age of 2 years old with type 1 diabetes or under the age of 18 years old with type 2 diabetes. It should also not be used in patients who require less than a total daily insulin dose of 5 units of insulin per day or who weigh less than 20 pounds (9 kilograms), as those are the required minimum values needed for Control-IQ+ to operate safely.
Users of the pump and Control-IQ+ must: use the insulin pump, iCGM, and all other system components in accordance with their respective instructions for use. Failure to follow these instructions for use could result in an over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events. Visit tandemdiabetes.com/safetyinfo for additional important safety information.
© 2026 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, the Tandem logo, Control-IQ+, t:slim X2, Tandem Source, and Tandem Mobi are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. iPhone is a trademark of Apple Inc., registered in the U.S. and other countries. Android and Google Play are trademarks of Google LLC. All third-party marks are the property of their respective owners.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260304073769/en/
Media Contact:
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Investor Contact:
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Original: Tandem Mobi Now Compatible with Android Smartphones
US Market News
4月前
Tandem Diabetes Care Prices Upsized Private Placement of $265 Million of Convertible Senior Notes Due 2032February 25, 2026 12:30 AM
Business Wire
Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a global insulin delivery and diabetes technology company, announced today the pricing of $265.0 million aggregate principal amount of 0.00% Convertible Senior Notes due 2032 (the “notes”) in a private placement (the “offering”) to persons reasonably believed to be qualified institutional buyers under Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). The offering was upsized from the previously announced offering size of $200.0 million aggregate principal amount of notes. Tandem also granted the initial purchasers of the notes an option to purchase, within the 13-day period beginning on, and including, the first date on which the notes are issued, up to an additional $35.0 million aggregate principal amount of notes from Tandem. The sale of the notes is expected to close on February 27, 2026, subject to customary closing conditions.
The notes will be general unsecured obligations of Tandem and will not bear regular interest and the principal amount of the notes will not accrete. The notes will mature on March 15, 2032, unless earlier converted, redeemed or repurchased.
Tandem estimates that the net proceeds from the offering will be approximately $256.7 million (or approximately $290.7 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by Tandem. Tandem expects to use the net proceeds from the offering to pay the approximately $13.5 million cost of the capped call transactions that it entered into as described below and the remainder for general corporate purposes, which may include acquisitions or strategic investments in complementary businesses or technologies, working capital, operating expenses and capital expenditure. If the initial purchasers exercise their option to purchase additional notes, Tandem expects to use a portion of the net proceeds from the sale of the additional notes to enter into additional capped call transactions and the remainder for general corporate purposes.
Before December 15, 2031, holders will have the right to convert their notes only upon the satisfaction of specified conditions and during certain periods. On or after December 15, 2031 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their notes at any time. Upon conversion, Tandem will pay or deliver, as the case may be, cash, shares of its common stock or a combination of cash and shares of its common stock, at its election. The conversion rate for the notes will initially be 27.0362 shares of Tandem’s common stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $36.99 per share of Tandem’s common stock). The initial conversion price represents a premium of approximately 37.5% over the last reported sale price of $26.90 per share of Tandem’s common stock on February 24, 2026. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued or unpaid special interest.
Tandem may not redeem the notes prior to March 20, 2029. Tandem may redeem for cash all or any portion of the notes (subject to certain limitations), at its option, on or after March 20, 2029 if the last reported sale price of Tandem’s common stock has been at least 130% of the conversion price for the notes then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which Tandem provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid special interest (if any) to, but excluding, the redemption date. However, Tandem may not redeem less than all of the outstanding notes unless at least $75.0 million aggregate principal amount of notes are outstanding and not called for redemption as of the time Tandem sends the related notice of redemption. No sinking fund is provided for the notes.
If Tandem undergoes a “fundamental change” (as defined in the indenture that will govern the notes), then, subject to certain conditions and limited exceptions, holders may require Tandem to repurchase for cash all or any portion of their notes at a fundamental change repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid special interest (if any) to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date or if Tandem delivers a notice of redemption, Tandem will, in certain circumstances, increase the conversion rate for a holder who elects to convert its notes in connection with such a corporate event or convert its notes called (or deemed called) for redemption in connection with such notice of redemption, as the case may be.
In connection with the pricing of the notes, Tandem entered into privately negotiated capped call transactions with one of the initial purchasers or its affiliate and certain other financial institutions (the “option counterparties”). The capped call transactions cover, subject to customary adjustments, the number of shares of Tandem’s common stock initially underlying the notes. The capped call transactions are expected to offset the dilution to Tandem’s common stock as a result of any conversion of the notes, with such offset subject to a cap. The cap price of the capped call transactions relating to the notes will initially be $47.075, which represents a premium of 75.0% over the last reported sale price of Tandem’s common stock on the Nasdaq Global Market on February 24, 2026, and is subject to certain adjustments under the terms of the capped call transactions.
In connection with establishing their initial hedges of the capped call transactions, Tandem expects that the option counterparties or their respective affiliates will enter into various derivative transactions with respect to Tandem’s common stock and/or purchase shares of Tandem’s common stock concurrently with or shortly after the pricing of the notes, including with, or from, certain investors in the notes. This activity could increase (or reduce the size of any decrease in) the market price of Tandem’s common stock or the notes at that time.
In addition, Tandem expects that the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Tandem’s common stock and/or purchasing or selling shares of Tandem’s common stock or other securities of Tandem in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so during the 40 trading day period beginning on the 41st scheduled trading day prior to the maturity date of the notes, or, to the extent Tandem elects to unwind a portion of the capped call transactions, following any repurchase, redemption, exchange or early conversion of the notes). This activity could also cause or avoid an increase or a decrease in the market price of Tandem’s common stock or the notes, which could affect a noteholder’s ability to convert its notes and, to the extent the activity occurs following conversion or during any observation period related to a conversion of notes, it could affect the amount and value of the consideration that a noteholder will receive upon conversion of such notes.
The notes and any shares of Tandem’s common stock issuable upon conversion of the notes have not been and will not be registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.
This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. Tandem’s pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ+ advanced hybrid closed-loop technology. Tandem is based in San Diego, California.
Tandem Diabetes Care, Tandem, the Tandem logo, Control-IQ+, Tandem Mobi and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries.
Forward-looking Statements
This press release includes forward-looking statements regarding, among other things, the offering, including statements regarding the closing of the offering of the notes and capped call transactions, the estimated net proceeds from the offering, the expected use of the net proceeds from the offering, the potential impact of the foregoing or related transactions on dilution to holders of our common stock and the market price of our common stock or the notes. Any statement describing our expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including, without limitation, changes in market conditions, whether we will be able to satisfy closing conditions related to the offering, whether the capped call transactions will become effective and unanticipated uses of capital, any of which could differ or change based upon market conditions or for other reasons. Tandem’s forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Tandem’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Tandem. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks are described in additional detail in Tandem’s annual report on Form 10-K for the year ended December 31, 2025, which is on file with the Securities and Exchange Commission.
In this press release, unless the context requires otherwise, “Tandem,” “Tandem Diabetes Care,” “we,” “our,” and “us” refers to Tandem Diabetes Care, Inc. and its subsidiaries.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260224110820/en/
Tandem Investor Contact:
858-366-6900
IR@tandemdiabetes.com
Original: Tandem Diabetes Care Prices Upsized Private Placement of $265 Million of Convertible Senior Notes Due 2032
US Market News
4月前
Tandem Diabetes Care Announces Proposed Private Placement of Convertible NotesFebruary 23, 2026 4:05 PM
Business Wire
Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a global insulin delivery and diabetes technology company, announced today that it intends to offer, subject to market conditions and other factors, $200.0 million aggregate principal amount of its Convertible Senior Notes due 2032 (the “notes”) in a private placement (the “offering”) to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). Tandem also intends to grant the initial purchasers of the notes an option to purchase, within the 13-day period beginning on, and including, the first date on which the notes are issued, up to an additional $30.0 million principal amount of notes.
The notes will be general unsecured obligations of Tandem and will accrue interest payable semiannually in arrears. Upon conversion, Tandem will pay or deliver, as the case may be, cash, shares of its common stock or a combination of cash and shares of its common stock, at its election. The interest rate, initial conversion rate and other terms of the notes will be determined at the time of pricing of the offering.
Tandem expects to use the net proceeds from the offering to pay the cost of the capped call transactions described below and the remainder for general corporate purposes, which may include acquisitions or strategic investments in complementary businesses or technologies, working capital, operating expenses and capital expenditure. If the initial purchasers exercise their option to purchase additional notes, Tandem expects to use a portion of the net proceeds from the sale of the additional notes to enter into additional capped call transactions and the remainder for general corporate purposes.
In connection with the pricing of the notes, Tandem expects to enter into privately negotiated capped call transactions with one or more of the initial purchasers or their respective affiliates and/or certain other financial institutions (the “option counterparties”). The capped call transactions will cover, subject to customary adjustments, the number of shares of Tandem’s common stock initially underlying the notes. The capped call transactions are expected to offset the dilution to Tandem’s common stock as a result of any conversion of the notes, with such offset subject to a cap.
In connection with establishing their initial hedges of the capped call transactions, Tandem expects that the option counterparties or their respective affiliates will enter into various derivative transactions with respect to Tandem’s common stock and/or purchase shares of Tandem’s common stock concurrently with or shortly after the pricing of the notes, including with, or from, certain investors in the notes. This activity could increase (or reduce the size of any decrease in) the market price of Tandem’s common stock or the notes at that time.
In addition, Tandem expects that the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Tandem’s common stock and/or purchasing or selling shares of Tandem’s common stock or other securities of Tandem in secondary market transactions following the pricing of the notes and before the maturity of the notes (and are likely to do so during the 40 trading day period beginning on the 41st scheduled trading day before the maturity date of the notes, or, to the extent Tandem elects to unwind a portion of the capped call transactions, following any repurchase, redemption, exchange or early conversion of the notes). This activity could also cause or avoid an increase or a decrease in the market price of Tandem’s common stock or the notes, which could affect a noteholder’s ability to convert its notes and, to the extent the activity occurs following conversion or during any observation period related to a conversion of notes, it could affect the amount and value of the consideration that a noteholder will receive upon conversion of such notes.
The notes and any shares of Tandem’s common stock issuable upon conversion of the notes have not been and will not be registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.
This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful before the registration or qualification thereof under the securities laws of any such state or jurisdiction.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. Tandem’s pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ+ advanced hybrid closed-loop technology. Tandem Diabetes Care is based in San Diego, California.
Tandem Diabetes Care, Tandem, the Tandem logo, Control-IQ+, Tandem Mobi and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries.
Forward-looking Statements
This press release includes forward-looking statements regarding, among other things, the proposed offering, including statements regarding the anticipated terms of the proposed offering and capped call transactions the completion, timing and size of the proposed offering and capped call transactions, the expected use of proceeds from the proposed offering, the potential impact of the foregoing or related transactions on dilution to holders of our common stock, and the market price of our common stock or the notes or the conversion price of the notes. Any statement describing our expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including, without limitation, changes in market conditions, our ability to complete the proposed offering on the expected terms, or at all, whether we will be able to satisfy closing conditions related to the proposed offering, changes in the structure or terms of the capped call transactions and unanticipated uses of capital, any of which could differ or change based upon market conditions or for other reasons. Tandem’s forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Tandem’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Tandem. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks are described in additional detail in Tandem’s annual report on Form 10-K for the year ended December 31, 2025, which is on file with the Securities and Exchange Commission.
In this press release, unless the context requires otherwise, “Tandem,” “Tandem Diabetes Care,” “we,” “our,” and “us” refers to Tandem Diabetes Care, Inc. and its subsidiaries.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260223015077/en/
Tandem Investor Contact:
858-366-6900
IR@tandemdiabetes.com
Original: Tandem Diabetes Care Announces Proposed Private Placement of Convertible Notes