Lastly, we made meaningful advancement in progressing our channel strategy in the development and in the development activities of our longer-term portfolio. The team has been executing particularly well on our strategy to provide people with insulin-dependent diabetes and their care teams flexibility and choice in insulin delivery. These achievements were made possible thanks to the hard work and perseverance of our employees. Thank you, everyone, for your continued dedication and efforts to contribute to ...

产品与技术 - 公司主要产品包括Tandem Mobi系统和t:slim X2胰岛素泵，均采用Control-IQ高级混合闭环技术[26] - 公司胰岛素泵产品包括t:slim X2和Tandem Mobi，均支持蓝牙连接和自动化胰岛素输送系统[33] - t:slim X2和Tandem Mobi泵采用Control-IQ技术，旨在增加用户在目标血糖范围内的停留时间，并已通过多项独立研究验证[34] - 公司提供与多种CGM传感器（如Dexcom G7和Abbott FreeStyle Libre 2 Plus）的集成，以提供定制化糖尿病管理解决方案[34] - 公司在美国推出了Tandem Mobi胰岛素泵，并计划推出t:slim X3，具备更强的处理能力和电池寿命[33][37] 市场与销售 - 公司在2023年12月31日前的四年间共出货约450,000台胰岛素泵，其中310,000台销往美国，140,000台销往美国以外市场[26][27] - 公司目标市场包括1型糖尿病患者和需要强化胰岛素治疗的2型糖尿病患者，估计在美国约有390万潜在用户[30] - 公司产品在25个国家销售，包括美国、加拿大、澳大利亚、德国等[39] - 公司通过直接销售和分销商合作在美国和加拿大销售产品，并在其他国家与分销商合作[39] - 公司在美国和加拿大的销售主要通过少数独立分销商进行，其中两家分销商在2023年分别占全球销售额的10%以上[39] - 公司在美国通过第三方支付方进行报销，客户通常每四年可获得一次胰岛素泵的保险报销[40] 风险与挑战 - 公司面临的主要风险包括未能实现持续盈利、依赖胰岛素泵销售、市场竞争、产品安全性和有效性问题、以及国际市场扩展的不确定性[6][7][8][13] - 公司依赖第三方供应商和分销商，若失去这些合作伙伴或无法准确预测客户需求，业务可能受损[11][9] - 公司面临监管和法律风险，包括产品召回、未能获得或维持必要的监管批准、以及知识产权纠纷[21][18][19] - 公司财务状况可能受宏观经济条件、公共卫生事件、气候变化等因素影响[14] - 公司可能需要未来融资以支持业务扩展，但存在融资困难的风险[15] - 公司面临隐私和安全风险，包括数据泄露、违反隐私法规等可能导致严重后果[16][17] - 公司股票价格可能大幅波动，且存在使用净营业亏损结转和其他税务属性的限制[22] 竞争与监管 - 公司面临来自多家公司的竞争，包括Insulet、Medtronic和Ypsomed，以及开发胰岛素输送系统和相关软件应用的其他公司[44] - 公司产品在美国需通过FDA的510(k)或PMA审批，510(k)审批通常需要3至12个月，PMA审批需大量技术、临床和制造数据支持[45] - 公司已获得多个设备的510(k)和PMA批准，包括Control IQ、tslim:X2和Tandem Mobi[45] - 公司正在赞助或支持多项临床试验，以支持未来AID产品的增强[46] - 公司需遵守多项监管要求，包括设备注册、质量体系要求、标签规定、医疗设备报告和召回规定[46] - 公司正在进行t:slim X2与Control-IQ技术的上市后监测研究，适用于6岁及以上1型糖尿病患者[47] - 公司需遵守美国联邦和州的反欺诈和滥用法律，包括联邦反回扣法、医生自我推荐法和联邦虚假索赔法[47][48] - 公司需遵守数据隐私和信息安全法规，包括HIPAA、HITECH、PIPEDA、GDPR等[49] - 公司需遵守《医生支付阳光法案》，报告与医疗专业人员和教学医院的支付和价值转移[51] - 公司需遵守国际法规，包括欧盟、美国、加拿大和其他工业化国家的质量体系标准[52] 公司治理与社会责任 - 公司总部位于美国加利福尼亚州圣地亚哥，拥有约2,400名全职员工，主要分布在美国、加拿大和欧洲[61] - 公司员工参与度调查显示，超过90%的员工参与，整体参与度超过Gallup全球和美国平均水平，以及专业、科学和技术服务行业和生命科学行业的平均水平[61] - 公司致力于多样性、公平性和包容性，超过一半的员工为女性，其中30%为副总裁级别或以上，约一半员工来自少数民族社区[61] - 公司提供全面的员工培训和发展计划，超过95%的参与员工继续在公司工作，约三分之一获得晋升或职责范围扩大[62] - 公司提供具有竞争力的薪酬和福利，包括股票期权、限制性股票单位、员工股票购买计划以及健康保险、带薪休假等福利[62][63][64][65] - 公司优先考虑员工健康和安全，提供员工援助和健康计划，以及全面的安全培训，目标为零事故[65] - 公司已获得CE标志，允许在欧盟市场销售t:slim X2胰岛素输送系统，并已获得加拿大卫生部批准在加拿大销售[57] - 公司遵循严格的法律和行业准则，包括欧洲国家的反贿赂法律、阳光规则、行业自我监管行为准则和医生专业行为准则[57][58][59] - 公司董事会和管理层认为环境、社会责任和公司治理对业务战略和长期价值创造至关重要，提名和公司治理委员会负责监督ESG事务[60] - 公司网站提供投资者中心部分，包含环境、社会和治理实践的更多信息，以及向SEC提交的文件副本[60][66]

San Diego, February 21, 2024 - Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a global insulin delivery and diabetes technology company, today reported its financial results for the quarter and year ended December 31, 2023 and provided its financial guidance for the year ending December 31, 2024. Fourth Quarter and Recent Highlights "We exited the year on a high note, demonstrating positive momentum across key areas of our business, including the unprecedented accomplishment of introducing four new products in ...

Tandem Diabetes Care, Inc. (NASDAQ:TNDM) Q3 2023 Earnings Conference Call November 1, 2023 4:30 PM ET Conference Call Participants Thank you for standing by, and welcome to Tandem's Third Quarter 2023 Earnings Conference Call. [Operator Instructions]. I would now like to hand the call over to EVP and Chief Administrative Officer, Susan Morrison. Madam, you may begin. As a reminder, today's discussion will include forward-looking statements. These statements reflect management's expectations about future eve ...

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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the T ...

Okay. Great. And I also wanted to ask 1 about the state of the U.S. commercial selling team in light of the current competitive environment, multiple new product launches, how are things progressing in the U.S.? And whatâs your outlook for either rep count or kind of the sales team going forward in light of the multiple new product launches youâve got late in the year and into 2024? John Sheridan Well, Iâd say theyâre incredibly excited. Theyâre motivated. They are really looking forward to getting their ha ...

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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transi ...

Tandem Diabetes Care, Inc. (NASDAQ:TNDM) Q1 2023 Earnings Conference Call May 3, 2023 4:30 PM ET Company Participants Susan Morrison - Executive Vice President and Chief Administrative Officer John Sheridan - President and Chief Executive Officer Brian Hansen - Executive Vice President and Chief Commercial Officer Leigh Vosseller - Executive Vice President and Chief Financial Officer Conference Call Participants Matthew Miksic - Barclays Steven Lichtman - Oppenheimer Christopher Pasquale - Nephron Research ...

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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Trans ...

Company Overview FEBRUARY 22, 2023 Safe Harbor CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Certain statements in this presentation constitute forward-looking statements, including, without limitation, statements about: the perceived advantages of our products relative to competitive products and technologies; our anticipated growth and other measures of future operating results and financial performance; the development and commercialization of new products; our ability to secure and maintain neces ...