Table of contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________________________________________________________ FORM 10-Q _____________________________________________________________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT ...

Table of contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________________________________________________________ FORM 10-Q _____________________________________________________________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to Commission File Number 001-36189 Tandem Diabetes Care, Inc. (Exact name of registrant as specified in its charter) Delaware 20-4327508 (State or other jurisdiction of ...

Financial Performance - Consolidated sales for the year ended December 31, 2018, were $183.9 million, a 71% increase from $107.6 million in 2017[27] - The net loss for the year ended December 31, 2018, was $122.6 million, compared to a net loss of $73.0 million in 2017[27] - In fiscal 2018, sales to Edgepark Medical Supplies, Inc. and Byram Healthcare accounted for 19.4% and 15.6% of consolidated sales, respectively[128] Product Overview - Worldwide pump sales accounted for 67% of total sales in 2018, while pump-related supplies and accessories accounted for the remainder[27] - The t:slim X2 platform represents 100% of new pump shipments, following the discontinuation of earlier models[20] - The t:slim X2 insulin pump is 38% smaller than the newest insulin pump from the leading competitor, making it the slimmest and smallest durable insulin pump on the market[59] - The t:slim X2 insulin pump features a high-resolution, color touchscreen and is designed to be intuitive, allowing for easier learning and teaching[61] - The t:slim X2 platform allows for software updates, enabling the introduction of new features and benefits during the typical four-year insurance pump replacement cycle[58] - The t:slim X2 can deliver insulin in increments as small as 0.001 u/hr, significantly more precise than traditional pumps which deliver at 0.025 u/hr[80] - The t:slim X2 features a micro-USB connection for rapid recharging and software updates without interrupting insulin delivery[69] - The t:slim X2 insulin pump features a vivid, full-color touchscreen and a user-friendly interface designed for rapid access to key features, enhancing user experience[89] Market and Customer Insights - The target market includes approximately 1.2 to 2.3 million people in the U.S. with type 1 diabetes and 3.2 million people with type 2 diabetes who manage their condition with insulin[21] - The global diabetes population is projected to increase from 425 million in 2017 to 629 million by 2045[31] - Approximately 42.5 million people worldwide have type 1 diabetes, representing about 10% of the diabetes population[5] - In the United States, an estimated 550,000 people use insulin pumps, with approximately 80% having type 1 diabetes[44] - Approximately 14% of people with type 2 diabetes in the United States, or 3.2 million people, manage their diabetes with insulin only[5] - The company estimates that between 750,000 and 1 million people worldwide used an insulin pump in 2015[44] Regulatory and Compliance - The FDA classified the t:slim X2 as the first insulin pump in the new category of Alternative Controller Enabled infusion pumps, enhancing regulatory flexibility[20] - The FDA review process for a PMA application generally takes between one and three years, which can be lengthy and uncertain[172] - Regulatory compliance failures can lead to enforcement actions by the FDA, including fines, delays in product approvals, and potential shutdown of manufacturing operations[178] - The company must comply with stringent QSR requirements, which include quality management and extensive record-keeping[180] - The company is subject to the Physician Payments Sunshine Act, requiring annual reporting of payments to physicians, with potential civil penalties for non-compliance[192] - International sales of medical devices require compliance with local regulations, which can vary significantly from country to country[194] Manufacturing and Production - The new manufacturing facility in San Diego has doubled production capacity for insulin pumps and cartridges, enhancing operational efficiencies[79] - The company has a maximum output capacity of approximately 110,000 insulin pumps and 12 million disposable cartridges annually, supporting an installed customer base of around 100,000 customers[152] - The company plans to substantially increase purchases of key components and sub-assemblies in 2019 to address production capacity limitations due to increased demand[154] Innovation and Technology - The company has launched the t:connect Diabetes Management Application, providing a cloud-based data management solution for customers and healthcare providers[25] - The t:slim X2 with Basal-IQ technology utilizes Dexcom G6 sensor values to minimize hypoglycemic events, making it the first CGM integrated insulin pump system that does not require fingersticks for calibration[94] - The Tandem Device Updater allows users to update their pumps' software quickly, with three software updates launched since its introduction, enhancing user capabilities[102][103] Leadership and Organizational Changes - Kim D. Blickenstaf will transition to Executive Chairman effective March 1, 2019, after serving as President and CEO since September 2007[198] - John F. Sheridan will become President and CEO effective March 1, 2019, having served as Executive Vice President and COO since April 2013[199] - The company has approximately 70 territories in its U.S. sales organization, supported by around 200 full-time employees in sales, clinical, and marketing roles[121] Future Outlook - The company anticipates commercial sales of the t:slim X2 with Control-IQ technology in the United States in the second half of 2019, followed by an international launch in 2020[112] - The company plans to broaden direct access to third-party payor reimbursement for its products to enhance consumer adoption[78] - The company anticipates continuing to expand commercial efforts outside the United States throughout 2019, including contracting with additional international distributors[127] Risks and Uncertainties - The annual report contains forward-looking statements regarding future financial conditions and operational results, which are subject to risks and uncertainties[12] - The company cautions that actual results may differ materially from those anticipated in forward-looking statements due to various factors[13] - The company does not undertake any obligation to update or review forward-looking statements unless required by law[15]