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Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 21, 2024, which discussion is incorporated herein by reference and which is available free of charge on the SEC’s website at www.sec.gov .
−Removed: We are a medical device company focused on the design, development and commercialization of technology solutions for people living with diabetes.
+Added: We are a global insulin delivery and diabetes technology company focused on the design, development and commercialization of technology solutions that reduce the burden of diabetes management.
We consider our primary addressable market to be people who live with type 1 diabetes.
−Removed: Through our product development efforts, we are seeking to expand our addressable market to include people living with type 2 diabetes who require intensive insulin therapy.
+Added: We are seeking to expand our addressable market to include people living with type 2 diabetes who require intensive insulin therapy.
Diabetes management can vary greatly from person-to-person, creating multiple market segments based on clinical needs and personal preferences.
−Removed: Our goal is to address the individual needs of people with insulin-dependent diabetes and their care team flexibility and choice in intelligent insulin delivery systems, through an accessible portfolio of market-leading pumps, applications, and insights.
−Removed: From inception in 2012 through June 2018, we derived nearly all of our sales from the shipment of insulin pumps and associated supplies to customers in the United States.
−Removed: Starting in the third quarter of 2018, we began selling in select geographies outside the United States and our technology solutions are now available in approximately 25 countries worldwide.
−Removed: In the four-year period ended December 31, 2023, we shipped approximately 450,000 insulin pumps, which is representative of our in-warranty global installed customer base assuming the typical four-year reimbursement cycle.
−Removed: The t:slim X2 has been our flagship technology solution.
−Removed: In February 2024, we expanded our pump portfolio with commercial U.S.
−Removed: availability of the Tandem Mobi insulin pump, which is the world’s smallest durable automated insulin delivery (AID) system.
+Added: Our goal is to address the individual needs of people with insulin-dependent diabetes and their care team, by offering flexibility and choice in intelligent insulin delivery systems, through an accessible portfolio of market-leading pumps, applications, and insights.
+Added: From inception in 2012 through 2018, we derived nearly all of our sales from the shipment of insulin pumps and associated supplies to customers in the United States.
+Added: Starting in the third quarter of 2018, we began selling in select geographies outside the United States and our technology solutions are now available in 25 countries worldwide.
+Added: Through our portfolio approach, we offer people living with diabetes a choice in their therapy management system based on their individual needs and preferences.
+Added: In support of this strategy, we recently expanded our portfolio which now includes both the t:slim X2 and the Tandem Mobi insulin pumps.
+Added: The Tandem Mobi insulin pump is the world’s smallest durable automated insulin delivery (AID) system.
At approximately half the size of our t:slim X2 pump, Tandem Mobi is designed for people who seek even greater discretion and flexibility, and includes features such as expanded pump-control from our iOS mobile application, inductive charging, and an on-pump button that can be used for bolusing and other actions.
−Removed: In the United States, a limited release of Tandem Mobi began in the fourth quarter of 2023 and commercial availability began in February 2024.
−Removed: With both the t:slim X2 and Tandem Mobi in our product portfolio, we are offering people living with diabetes a choice between the t:slim X2 and Tandem Mobi insulin pumps based on their individual needs and preferences in insulin delivery.
−Removed: The majority of our customers use their insulin pump with continuous glucose monitoring (CGM) integration.
+Added: Beginning in early 2024, we scaled the commercial release of Tandem Mobi in the United States, first offering CGM integration with the Dexcom G6 sensor beginning in February followed by the Dexcom G7 beginning in June.
+Added: The vast majority of our customers use their insulin pump with CGM integration.
This allows their insulin pump to receive CGM sensor readings, which can then be used in our AID algorithms, including our Control-IQ technology.
Control-IQ is an advanced hybrid-closed loop feature designed to help increase a user’s time in their targeted glycemic range.
−Removed: Multiple studies have demonstrated that use of Control-IQ technology provides people across all demographics with improved clinical outcomes that are both immediate and sustained.
−Removed: It was the first system cleared by the FDA to deliver automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar.
−Removed: The t:slim X2 was the first pump on which remote software updates were made commercially available in the United States and is now also available in the countries we serve worldwide.
−Removed: Our Tandem Device Updater (TDU) has allowed our t:slim X2 customers to update their pump software from a personal computer.
−Removed: Tandem Mobi offers the same update capability with wireless, remote updates.
−Removed: This offering is a competitive advantage that allows us to bring our customers clinical and lifestyle enhancements, such as new developments in our AID technology, CGM integrations and mobile app features.
−Removed: As an example, we recently launched a pump software update through TDU to allow all t:slim X2 pump users in the United States access to integration with two new CGM sensor offerings.
−Removed: Our insulin pump products are generally considered durable medical equipment and have an expected lifespan of at least four years.
−Removed: In addition to insulin pumps, we sell single-use products that are used together with our pumps and are replaced every few days, including cartridges for storing and delivering insulin, and infusion sets that connect the insulin pump to a user’s body.
−Removed: In the United States, we also offer a data management web application that provides users, their caregivers and their healthcare providers with a fast, easy and visual way to display diabetes therapy management data from our pumps, integrated CGMs and supported blood glucose meters.
−Removed: Our first-generation data management application, t:connect, was commercially introduced in the United States in 2013.
−Removed: In the second quarter of 2023, we began a scaled global launch, starting with the United States, of our second-generation data management application, Tandem Source.
−Removed: Recent Developments
−Removed: Tandem Diabetes Care Launches Tandem Mobi, the World’s Smallest, Durable Automated Insulin Delivery System
−Removed: In February 2024, we announced the United States commercial launch of our new Tandem Mobi, the world’s smallest, durable automated insulin delivery system for people living with diabetes.
−Removed: We have begun taking orders and shipping to eligible customers in the United States.
−Removed: Integration of t:slim X2 with Abbott’s FreeStyle Libre 2 Plus Sensor
−Removed: In January 2024, we announced that the t:slim X2 insulin pump with Control-IQ technology became the first AID system to integrate with newly available FreeStyle Libre 2 Plus sensor, Abbott’s latest CGM technology.
−Removed: Users in the United States are now able to experience the therapeutic benefits of a hybrid closed-loop system that helps predict and prevent high and low blood sugar.
−Removed: Tandem’s t:slim X2 insulin pump connects wirelessly to the FreeStyle Libre 2 Plus sensor, which sends automatic glucose readings every minute to the pump.
−Removed: Pump Reimbursement Cycle
−Removed: Insulin pumps in the markets we serve worldwide are generally subject to a four-year reimbursement cycle, imposed by the third-party insurance carrier, government plan or healthcare system that serves as the primary payor.
−Removed: At the end of the typical four-year reimbursement cycle, customers may be eligible to purchase a new insulin pump, subject to the rules and requirements of their primary insurance payor.
−Removed: While warranties generally expire four years from the original pump shipment date, those customers that renew typically take up to one year from date of warranty expiration to purchase a subsequent pump.
−Removed: While the majority of our insulin pump sales from initial commercialization through the current period have been generated by sales to new customers, the opportunity to make subsequent sales of renewal insulin pumps to existing customers increases each period as an escalating number of customer warranties expire.
−Removed: With programs dedicated to customer retention efforts, we expect such renewal purchases to represent an increasing portion of our pump shipments over time.
−Removed: In the four-year period ended December 31, 2023, we shipped more than 450,000 insulin pumps worldwide, which is representative of our global in-warranty installed customer base.
−Removed: Our ending estimated worldwide installed customer base increased approximately 7% year over year.
−Removed: Over 310,000 pumps were shipped to customers in the United States in the four-year period ended December 31, 2023, which is representative of our U.S.
−Removed: installed customer base.
−Removed: We shipped approximately 140,000 pumps outside the United States in the four-year period ended December 31, 2023 and our products are now available in approximately 25 countries.
−Removed: The ordering patterns of, and levels of inventory carried by, our distributors outside the United States for pumps and supplies have historically been highly variable from period to period due to a number of factors, including summer vacations, the timing of product launches into new geographies and variability due to supply chain logistics, particularly during the global pandemic.
−Removed: This also influences the timing in which renewal eligibility begins for existing customers, which may not initially be consistent with trends in the U.S.
−Removed: We recently began completing a full four-year reimbursement cycle in an increasing number of our markets outside of the United States.
+Added: Multiple studies, including three publications in the New England Journal of Medicine, have demonstrated that use of Control-IQ technology provides people across all demographics with improved clinical outcomes that are both immediate and sustained.
+Added: The t:slim X2 was the first pump in the industry on which remote software updates were made commercially available in the United States and is now also available in the countries we serve worldwide.
+Added: This feature allows our t:slim X2 and Tandem Mobi customers to update their pump software independently.
+Added: We believe this offering is a competitive advantage that allows us to bring our customers clinical and lifestyle enhancements within their warranty cycle without having to purchase a new pump.
+Added: These enhancements include new developments in our AID technology, CGM integrations and mobile app features.
+Added: For example, in 2024 we offered pump software updates to allow Tandem pump users access to integration with new CGM sensors.
+Added: For more than a decade we have offered our customers, their caregivers and healthcare providers a data management application to provide a fast, easy and visual way to display diabetes therapy management data from our pumps and integrated CGMs.
+Added: In the second quarter of 2023, we expanded our digital technology solutions with the launch of Tandem Source in the United States.
+Added: In addition to displaying diabetes therapy management data, Tandem Source is also designed to serve as a portal for supplies reordering and pump software updates.
+Added: In the second quarter of 2024, we began a scaled launch of Tandem Source outside the United States.
+Added: Our Strategy & Future Technology
+Added: Diabetes management can vary greatly from person-to-person, creating multiple market segments based on clinical needs and personal preferences.
+Added: Our goal is to redefine global leadership in insulin delivery with an accessible portfolio of transformational devices, applications and services that reduce the daily burden of living with diabetes.
+Added: In support of this strategy, our portfolio of future technologies includes enhancing the features and capabilities of our t:slim X2 and Tandem Mobi insulin pump platforms, including adding a tubeless infusion site option for Tandem Mobi users.
+Added: Our development efforts also include Sigi, our ergonomic and rechargeable patch pump, in addition to extended wear infusion technology and algorithm advancement in pursuit of offering fully closed loop technology.
Trends and Uncertainties Impacting Financial Results
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• Sales of new products are subject to local government regulations.
−Removed: The requirements and timelines to receive regulatory clearance can vary substantially from country to country and delays may impact our ability to expand
−Removed: our worldwide customer base and bring products to market in a competitive timeframe.
+Added: The requirements and timelines to receive regulatory clearance can vary substantially from country to country and delays may impact our ability to expand our worldwide customer base and bring products to market in a competitive timeframe.
These delays, or failure to receive regulatory approval could adversely impact our revenue and results of operations.
−Removed: • Any adverse event involving any products that we distribute could result in future corrective actions, such as recalls or customer notifications, or regulatory agency action, which could include inspection, mandatory recall or other enforcement action.
+Added: • Any adverse event involving products that we distribute could result in future corrective actions, such as recalls or customer notifications, or regulatory agency action, which could include inspection, mandatory recall or other enforcement action.
Any action by regulatory bodies against us, and any regulatory challenges we encounter could have a negative impact on our product sales and harm our reputation.
−Removed: Product - Launches and Reimbursement
+Added: Markets, Seasonality, Competition, and Product Launches
• We expect our business to be impacted by the introduction of new diabetes devices and treatments by us or our competitors.
The success of our products is variable and we believe it correlates to market acceptance, anticipated product launches and commercial availability.
−Removed: We anticipate that our Tandem Choice program, and its related financial and accounting impact, may continue to materially impact our business until the conclusion of the program.
−Removed: • We have historically experienced higher net sales in our third and fourth quarters compared to the first half of the year.
−Removed: We believe our July 2023 announcement of FDA clearance of Tandem Mobi and its anticipated launch impacted the timing of purchasing decisions by our current and prospective customers in the second half of 2023 up through the U.S.
−Removed: commercial availability of Tandem Mobi in February 2024, resulting in delays that were unlike historical seasonal patterns or purchasing behaviors.
−Removed: Regulatory approval and/or upcoming launches of other new Tandem or competitor products could also adversely impact timing of purchasing decisions.
−Removed: • In periods following new product launches, particularly with new hardware platforms, our cost of sales may increase on a per unit basis until the new products achieve manufacturing scale and operating expenses may be elevated by increased sales and marketing spend to support the product launches.
−Removed: • Our revenue and results of operations may be impacted by the failure to secure or retain adequate coverage or reimbursement for our current and future products from third-party payors, as well as changes in reimbursement structures.
−Removed: Foreign Markets
−Removed: • We have expanded our business and launched new products in select geographies outside the United States.
−Removed: The ordering patterns of our distributors outside the United States is highly variable from period to period.
−Removed: For example, we began operations of a European distribution center beginning in the third quarter of 2022, which led to downward adjustments of inventory levels at our distributors starting in late 2022 and continuing through the first half of 2023.
• Seasonality in the United States is associated with annual insurance deductibles and coinsurance requirements of the medical insurance plans used by our customers and the customers of our distributors.
−Removed: In the United States, we typically experience a higher volume of pump shipments in the third and fourth quarters due to the nature of the reimbursement environment.
−Removed: Other factors that may impact sales across the year include the timing of winter, summer and other seasonal holidays, particularly in our markets outside the United States, as well as the anticipated launch of new products.
+Added: In the United States, we typically experience a higher volume of pump shipments in the second half of the year due to the nature of the reimbursement environment.
+Added: Other factors that may impact sales across the year include the timing of winter, summer and other seasonal holidays, particularly in our markets outside the United States.
+Added: • Regulatory approval and/or upcoming launches of other new Tandem or competing products could also adversely impact timing of purchasing decisions.
+Added: • In periods following new product launches, particularly with new hardware platforms, our cost of sales may increase on a per unit basis until the new products achieve manufacturing scale and operating expenses may be elevated by increased sales and marketing spend to support the product launches.
+Added: For example, we began operations of a European distribution center which led to a reduction of inventory levels at our distributors, significantly impacting sales patterns in the second half of 2022 and first half of 2023.
+Added: Reimbursement
+Added: • Our insulin pump products are generally considered durable medical equipment (DME) and have an expected lifespan of at least four years.
+Added: In addition to insulin pumps, we sell single-use products that are used together with our pumps and are replaced every few days, including cartridges for storing and delivering insulin, and infusion sets that connect the insulin pump to a user’s body.
+Added: Because of the DME classification, our pumps and supplies are typically reimbursed through a medical benefit.
+Added: As our portfolio expands, we are implementing a multi-channel managed care strategy and have begun serving Mobi customers through the pharmacy channel on a scaled basis in 2025.
+Added: • We generally have had broad insurance coverage for our current products from third-party payors.
+Added: Our revenue and results of operations may be impacted by the failure to secure or retain adequate coverage, changes in reimbursement structures or availability of affordable options for our customers.
Macroeconomic Factors
−Removed: • Global economic and market uncertainty, such as recessionary concerns, inflation, changes in discretionary spending and increased interest rates have impacted our customers’ purchasing decisions and the buying patterns of our distributors.
−Removed: • High inflation and the effects of other macroeconomic factors and concerns have continued to disrupt our relationships with suppliers, third-party manufacturers, healthcare providers, distributors and our existing or potential customers.
−Removed: We are experiencing higher costs as we navigate these global macroeconomic challenges.
+Added: • Global economic and market uncertainty, such as recessionary concerns, changes in discretionary spending and increased interest rates have impacted our customers’ purchasing decisions and the buying patterns of our distributors.
+Added: • High inflation, fluctuations in foreign currency valuations, uncertainty regarding tariffs and the effects of other macroeconomic factors and concerns has disrupted and may continue to disrupt our relationships with suppliers, third-party manufacturers, healthcare providers, distributors and our existing or potential customers.
Components of Results of Operations
−Removed: We offer products for people with insulin-dependent diabetes in approximately 25 countries.
−Removed: The t:slim X2 insulin pump has been our flagship pump platform.
−Removed: Our other products include single-use insulin cartridges and infusion sets, as well as our complementary t:connect, TDU and mobile application products.
+Added: We offer products for people with insulin-dependent diabetes, including a portfolio of hardware platforms, single-use insulin cartridges and infusion sets, data management platforms and mobile applications.
Our primary customers are the end users of our products, non-exclusive distribution partners whose level of service varies based on geography, the healthcare professionals who prescribe our products and the healthcare systems or payors who provide insurance coverage and access to our products.
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Therefore, the lowest percentage of sales is typically reported in the first quarter of each calendar year and the highest percentage is typically reported in the fourth quarter.
−Removed: See also “Trends and Uncertainties Impacting Financial Results—Seasonality” above.
−Removed: In September 2022, we began offering the Tandem Choice program to eligible t:slim X2 customers to provide a pathway to ownership of our newest hardware platform, Tandem Mobi, for a fee when available.
−Removed: Tandem Choice expires on December 31, 2024.
−Removed: The accounting treatment for Tandem Choice is complex (see Note 2, “Summary of Significant Accounting Policies”).
−Removed: Initially, the program requires the deferral of some portion of sales for shipments of eligible pumps, which began in the third quarter of 2022.
−Removed: No election is made by the customer at the time of the initial sale, nor does the right offered to the customer impact the economics associated with how or when the initial pump sale is reimbursed.
−Removed: If a customer elects to participate in Tandem Choice at a future date beginning with the launch of our next generation hardware platform, Tandem Mobi, we will recognize the existing deferral, incremental fees received and the associated costs of providing the new hardware, Tandem Mobi, at the time of fulfillment.
−Removed: Any remaining deferrals will be recognized at program expiration.
−Removed: At this time, we are not able to estimate the financial impact for the remainder of the Tandem Choice period.
+Added: See also “Trends and Uncertainties Impacting Financial Results—”Markets, Seasonality, Competition, and Product Launches” above.
+Added: From September 2022 through February 2024, we offered the Tandem Choice program to eligible t:slim X2 customers to provide a pathway to ownership of our newest hardware platform, Tandem Mobi, for a fee once available.
+Added: Eligible customers who purchased a t:slim X2 insulin pump during the program period had until December 31, 2024 to exercise the option to switch to the Tandem Mobi for a stated fee.
+Added: The accounting treatment for Tandem Choice was complex (see Note 2, “Summary of Significant Accounting Policies”).
+Added: The program required the deferral of some portion of sales for shipments of eligible pumps between the third quarter of 2022 and the first quarter of 2024.
+Added: No election was made by the customer at the time of the initial sale, nor did the right offered to the customer impact the economics associated with how or when the initial pump sale was reimbursed.
+Added: When a customer elected to participate in Tandem Choice, we recognized the existing sales deferral, incremental fees received and the associated costs of goods sold for the new insulin pump, Tandem Mobi, at the time of fulfillment.
+Added: Qualifying customers were able to elect participation in Tandem Choice starting near the end of the second quarter of 2024.
+Added: The remaining deferral balance was recognized as revenue when the program ended on December 31, 2024.
Cost of Sales
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Manufacturing overhead expenses include expenses relating to quality assurance, manufacturing engineering, material procurement, inventory control, facilities, equipment, information technology and operations supervision and management.
−Removed: When taking into consideration the differences in reimbursement levels and cost structure, pumps have, and are expected to continue to have, a higher gross profit and gross margin percentage than our pump-related supplies.
+Added: When taking into consideration the differences in reimbursement levels and cost structure, pumps have, and are expected to continue to have, a higher gross profit and gross margin percentage than our pump-related supplies on a per unit basis.
Therefore, the percentage of pump sales relative to total sales could have a significant impact on our overall gross margin percentage.
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Our selling, general and administrative (SG&A) expenses primarily consist of salary, cash-based incentive compensation, fringe benefits and non-cash stock-based compensation for our sales, marketing and administrative functions, which also includes our clinical, customer support, technical services, insurance verification and regulatory affairs personnel.
−Removed: We have approximately 110 sales territories in the United States, which are generally maintained by sales representatives and field clinical specialists, and supported by managed care liaisons, additional sales management and other customer support personnel.
+Added: Our sales territories in the United States are generally maintained by sales representatives and field clinical specialists, and supported by managed care liaisons, additional sales management and other customer support personnel.
Other significant SG&A expenses typically include those incurred for commercialization activities associated with new product launches, travel, trade shows, outside legal fees, independent auditor fees, outside consultant fees, insurance premiums, facilities costs and information technology costs.
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R&D expenses are primarily related to employee compensation, including salary, cash-based incentive compensation, fringe benefits and non-cash stock-based compensation.
−Removed: We also incur R&D expenses for supplies, development prototypes, outside design and testing services, depreciation, allocated facilities and information services, clinical trial costs, payments under our licensing, development and commercialization agreements and other indirect costs.
−Removed: Acquired In-process Research and Development (IPR&D) Expenses
+Added: We also incur R&D expenses for supplies, development prototypes, outside design and testing services, depreciation, allocated facilities and information services, clinical trials, payments under our licensing, development and commercialization agreements and other indirect costs.
+Added: Acquired In-process Research and Development (IPR&D)
Acquired IPR&D reflects costs of external research and development projects acquired directly in a transaction other than a business combination, that do not have an alternative future use.
Other Income and Expense
−Removed: Other income and expense primarily consists of interest earned on our cash equivalents and short-term investments, foreign currency transaction gains and losses, and interest expense which includes the amortization of debt issuance costs related to our 1.50% Convertible Senior Notes due May 2025 (Notes).
−Removed: In October 2023, we were notified that additional interest beyond the 1.50% per annum had been accruing on the Notes since May 2021, pursuant to the terms of the indenture.
−Removed: The additional accrued interest of $3.3 million was fully paid in November 2023 (see Note 7, “Debt”).
+Added: Other income and expense primarily consists of interest earned on our cash equivalents and short-term investments, income or loss from equity method investments, foreign currency transaction gains and losses and interest expense which includes the amortization of debt issuance costs related to our convertible senior notes.
Income Tax Expense (Benefit)
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Total operating expenses 588,701 600,920
−Removed: Operating income (loss) (233,230) (92,848) 22,653
+Added: Operating loss
+Added: (99,127) (233,230)
Other income (expense), net:
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Interest expense (7,415) (9,882)
+Added: Loss from equity method investment
+Added: Loss on extinguishment of debt (1,268) —
Change in fair value of common stock warrants — —
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Income tax expense 4,155 2,357
−Removed: Net income (loss) $ (222,611) $ (94,594) $ 15,566
+Added: $ (96,025) $ (222,611)
+Added: Pump Reimbursement Cycle
+Added: Insulin pumps in the markets we serve worldwide are generally subject to a four-year reimbursement cycle, imposed by the third-party insurance carrier, government plan or healthcare system that serves as the primary payor.
+Added: At the end of the typical four-year reimbursement cycle, customers may be eligible to purchase a new insulin pump, subject to the rules and requirements of their primary insurance payor.
+Added: While warranties generally expire four years from the original pump shipment date, those customers that renew take on average up to one year from date of warranty expiration to purchase a subsequent pump.
+Added: While the majority of our insulin pump sales from initial commercialization through the current period have been generated by sales to new customers, the opportunity to make subsequent sales of renewal insulin pumps to existing customers increases each period as an escalating number of customer warranties expire.
+Added: With programs dedicated to customer retention efforts, we expect such renewal purchases to represent an increasing portion of our pump shipments over time.
+Added: At December 31, 2024, we had over 480,000 users in our in-warranty installed base, approximately one-third of whom live outside the United States.
+Added: The ordering patterns of, and levels of inventory carried by, our distributors outside the United States for pumps and supplies have historically been highly variable from period to period due to a number of factors, including summer vacations, the timing of product launches, expansion into new geographies and variability due to supply chain logistics, particularly during the global pandemic.
+Added: This also influences the timing in which renewal eligibility begins for existing customers, which may not initially be consistent with trends in the United States market.
+Added: We recently began completing full four-year reimbursement cycles in an increasing number of our markets outside of the United States.
Comparison of Years Ended December 31, 2024 and 2023
−Removed: For the year ended December 31, 2023, sales were $747.7 million, which included $192.8 million of sales outside the United States.
−Removed: For the year ended December 31, 2023, we deferred $25.1 million of pump sales as the result of our Tandem Choice program which launched in the United States in the third quarter of 2022.
−Removed: In addition, for the year ended December 31, 2023, we recorded a reduction to sales of $8.5 million for a new rebate structure implemented in a market outside of the United States.
−Removed: For the year ended December 31, 2022, sales were $801.2 million, which included $212.5 million of sales outside the United States, and we deferred $3.5 million of pump sales as a result of our Tandem Choice program.
+Added: For the year ended December 31, 2024, we shipped more than 120,000 pumps worldwide.
+Added: Sales were $940.2 million, which included $267.5 million of sales outside the United States.
+Added: For the year ended December 31, 2024, we recognized $30.2 million in net revenue from pump sales as the result of the conclusion of our Tandem Choice program which launched in the United States in the third quarter of 2022 and ended in 2024.
+Added: For the year ended December 31, 2023, sales were $747.7 million, which included $192.8 million of sales outside the United States, and deferral of $25.1 million of pump sales as a result of Tandem Choice.
Sales by product in the United States were as follows (dollars in thousands):
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2024 2023 % Change
−Removed: Pumps shipped
−Removed: 74,000 84,000 (12)%
Pump $ 328,625 $ 289,546 13%
Supplies and other 313,811 290,439 8%
−Removed: Deferral for Tandem Choice program (25,107) (3,549) 607%
+Added: Net revenue recognized (deferred) for Tandem Choice program
+Added: 30,249 (25,107) 220%
Total Sales in the United States $ 672,685 $ 554,878 21%
−Removed: Pump sales in the United States were $289.5 million for the year ended December 31, 2023 compared to $329.1 million for the year ended December 31, 2022, as pump shipments decreased 12% compared to the year ended December 31, 2022.
−Removed: Throughout 2023, we faced challenging marketplace dynamics and economic conditions, with inflation and the threat of recession impacting pump purchasing decisions.
−Removed: Additionally, we believe the anticipation of the full release of new CGM sensor integrations with t:slim X2 and the FDA clearance of Tandem Mobi in July 2023 impacted the timing of purchasing decisions for those offerings, resulting in some customers delaying current purchases until commercial availability of these products in future periods.
−Removed: Sales of pump-related supplies increased primarily due to a 7% year-over-year increase in our ending estimated installed base of customers in the United States.
+Added: Pump sales in the United States were $328.6 million for the year ended December 31, 2024 compared to $289.5 million for the year ended December 31, 2023.
+Added: Our pump shipments in the United States increased approximately 10% to nearly 81,000 pumps compared to the year ended December 31, 2023.
+Added: We also benefited from higher average selling prices across all product lines, driven by price increases and favorable customer mix, as we continue to shift a higher percent of sales from distribution to our direct channel.
Sales to distributors accounted for 61% and 64% of our total sales in the United States for the years ended December 31, 2024 and 2023, respectively.
−Removed: Sales in the United States for the years ended December 31, 2023 and 2022 were reduced by a deferral of $25.1 million and $3.5 million, respectively, as the result of our Tandem Choice program which launched in September of 2022.
−Removed: The increase in the sales deferral for Tandem Choice in 2023 as compared to 2022 was primarily related to a reduction in the Tandem Choice program price.
−Removed: This change became effective in the third quarter of 2023, resulting in an increase to our estimate of the future customer participation rate and, therefore, a higher deferral per pump sold, coupled with the Tandem Choice program being in effect for the entire year of 2023.
+Added: Sales of pump-related supplies increased primarily due to a year-over-year increase in our installed base of customers in the United States, as well as an increase in average selling prices.
+Added: We also recognized $30.2 million in net revenue from pump sales due to the conclusion of Tandem Choice during the year ended December 31, 2024.
+Added: Sales in the United States for the year ended December 31, 2023 were reduced by $25.1 million in sales deferrals related to Tandem Choice.
Sales by product outside the United States were as follows (dollars in thousands):
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2024 2023 % Change
−Removed: Pumps shipped
+Added: Pump, net of rebates
105,544 76,296 38%
−Removed: Pump $ 84,748 $ 102,846 (18)%
−Removed: Pump rebate (8,452) — —%
Supplies and other 161,974 116,544 39%
Total Sales Outside the United States $ 267,518 $ 192,840 39%
−Removed: Pump sales outside the United States were $76.3 million for the year ended December 31, 2023, compared to $102.8 million in the prior year.
−Removed: We began operations of a centralized European distribution center in late 2022.
−Removed: This resulted in a material disruption to distributor ordering patterns in the first half of 2023 as affected distributors reduced their pump and supply inventory levels to adjust for the reduced transit time.
−Removed: As a result, pump shipments decreased 32% compared to the year ended December 31, 2022.
−Removed: The year-over-year changes in pump and supply shipments were not directly correlated with actual customer demand.
−Removed: The decrease in pump sales was partially offset by an increase in average selling prices due primarily to geographical mix.
−Removed: Pump sales outside the United States also included a reduction to sales of $8.5 million for a new rebate structure implemented in a single market.
−Removed: Sales to distributors accounted for 99% and 96% of our total sales outside the United States for the years ended December 31, 2023 and 2022, respectively.
+Added: Pump sales, net of rebates, outside the United States were $105.5 million for the year ended December 31, 2024, compared to $76.3 million in the prior year.
+Added: Our pump shipments outside the United States increased by 30% to nearly 40,000 pumps for the year ended December 31, 2024 compared to the year ended December 31, 2023.
+Added: Pump sales outside the United States in 2023 included a reduction of $8.5 million for the establishment of the new rebate structure implemented in a single market.
+Added: Sales of pump-related supplies increased due to a year-over-year increase in our installed base of customers outside the United States.
+Added: In addition, for the year ended December 31, 2024, we recorded a reduction to sales of $1.5 million due to sales rebates outside of the United States.
Cost of Sales and Gross Profit
1 unchanged sentence
The gross margin for 2024 was 52%, compared to 49% in 2023.
−Removed: The decrease in our gross profit for the year ended December 31, 2023 was primarily the result of the $53.5 million decrease in total sales, driven by lower pump shipments and an increase in sales deferral related to the Tandem Choice Program.
−Removed: Amounts deferred were $25.1 million and $3.5 million for the years ended December 31, 2023 and 2022, respectively.
−Removed: This deferral reduced gross margin by approximately two percentage points in 2023, but had negligible impact in 2022.
−Removed: The impact on gross margin from our Tandem Choice program will fluctuate through the expiration of the program based on the timing of availability of Tandem Mobi and the number of eligible customers who ultimately elect to participate.
−Removed: In addition, the sales rebate of $8.5 million also negatively impacted gross margin by nearly one percentage point.
−Removed: Gross margin benefited from progress in underlying fundamentals, including lower material cost, an increase in average selling prices and manufacturing efficiencies, as well as leverage of fixed overhead.
−Removed: These benefits were offset by the impact of product and geographical mix.
+Added: The increase in our gross profit for the year ended December 31, 2024 was primarily the result of the $192.5 million increase in total sales, driven by higher pump shipments, the impact of the conclusion of the Tandem Choice program and the greater impact of the sales rebate structure outside the United States in 2023 compared to 2024.
+Added: Additionally, we recognized charges to cost of sales of $1.3 million for Tandem Choice fulfillments in 2024, with no corresponding charge in 2023.
+Added: The net effect of the Tandem Choice adjustments increased gross margin by approximately one percentage point in 2024 and decreased gross margin by approximately two percentage points in 2023.
+Added: The new rebate structure negatively impacted gross margin by nearly one percentage point in 2023.
+Added: Excluding the impact of Tandem Choice and the sales rebate outside the United States, gross margin benefited from pricing improvement across all product lines and lower pump materials cost, offset by higher labor, overhead and non-manufacturing costs on a per-unit basis as we continued to scale the launch of Tandem Mobi.
+Added: Gross margin was positively impacted by product mix.
Pump sales, which have the highest gross margin, were 49% of total worldwide sales, excluding the impact of Tandem Choice in 2024, compared to 46% in 2023.
1 unchanged sentence
Our operating expenses for the year ended December 31, 2024 were $588.7 million, compared to $600.9 million for the year ended December 31, 2023.
−Removed: A significant portion of the increase was driven by certain unique or non-recurring transactions.
−Removed: In 2023, we incurred $78.8 million of acquired in-process research and development expenses in connection with our acquisition of AMF Medical, compared to $31.0 million of acquired IPR&D expenses in connection with our acquisition of Capillary Biomedical in 2022 (see Note 12, “Acquisitions”).
−Removed: Additionally, personnel and discretionary spending attributable to these acquisitions, in both SG&A and R&D, was $22.4 million in 2023 and $3.3 million in 2022.
−Removed: As a part of continued operating efficiency measures in 2023 and 2022, we incurred non-recurring operating lease impairment charges in SG&A of $14.1 million and $12.4 million, respectively, from a facilities consolidation (see Note 6, “Leases”).
−Removed: In 2023, we also incurred employee severance costs of $2.7 million.
Selling, General and Administrative Expenses.
SG&A expenses increased 11% to $389.8 million for the year ended December 31, 2024, from $352.5 million for the same period in 2023.
−Removed: Employee-related expenses for our SG&A functions comprise the majority of SG&A expenses.
−Removed: Excluding the severance costs described above, the remaining increase of $11.9 million in salaries, incentive compensation, and other employee benefits was primarily the result of continued support services for our growing installed customer base.
−Removed: We also experienced a $2.8 million increase in other non-employee discretionary spending, primarily attributable to outside consulting, outside services, and travel, in addition to the impact of facilities consolidation charges described above.
+Added: Employee-related expenses for our SG&A functions comprised the majority of our SG&A expenses, which increased $33.6 million due to continued support services for our growing installed customer base.
+Added: Excluding certain non-recurring facilities consolidations costs of $14.1 million from 2023, we experienced a $17.9 million increase in other non-employee discretionary spending, primarily attributable to outside consulting, outside services, and supplies.
Research and Development Expenses .
1 unchanged sentence
The increase in R&D expenses was primarily the result of a $20.3 million increase in salaries and related benefits due to our acquisitions, as well as an increase in personnel to support our product development efforts.
−Removed: We also experienced a $7.5 million increase in other non-employee discretionary spending, including equipment and supplies costs, clinical trial expenses, and information technology costs attributable to R&D.
+Added: We also experienced an $8.5 million increase in other non-employee discretionary spending, including outside services and consulting, clinical trial expenses, and equipment costs attributable to R&D.
Acquired In-Process Research and Development Expenses.
−Removed: Acquired IPR&D expenses of $78.8 million for the year ended December 31, 2023 represented the value of assets acquired, and acquisition-related expenses, in connection with our acquisition of AMF Medical (see Note 12, “Acquisitions”).
−Removed: Acquired IPR&D expenses of $31.0 million for the year ended December 31, 2022 represented the value of assets acquired, and acquisition-related expenses in connection with our acquisition of Capillary Biomedical.
+Added: Acquired IPR&D expenses of $78.8 million for the year ended December 31, 2023, pertained to our 2023 acquisition of AMF Medical (see Note 12, “Acquisitions”).
Other Income (Expense), Net
−Removed: Total other income, net for the year ended December 31, 2023 was $13.0 million, compared to expense of $4,000 in 2022.
−Removed: Other income, net for 2023 primarily consisted of $21.2 million of interest income earned on our cash equivalents and short-term investments, and $1.5 million in foreign currency transaction gains, partially offset by $9.9 million of interest expense which included $3.3 million of additional interest as discussed above and the amortization of debt issuance costs related to our Convertible Senior Notes.
−Removed: Other expense, net for 2022 consisted primarily of $6.2 million of interest expense related to our Convertible Senior Notes, offset by $6.1 million of interest income earned on our cash equivalents and short-term investments.
−Removed: Interest income increased in 2023 primarily due to the higher interest rate environment as compared to 2022.
+Added: Total other income, net for the year ended December 31, 2024 was $7.3 million, compared to $13.0 million in 2023.
+Added: Other income, net for 2024 primarily consisted of $22.1 million of interest income earned on our cash equivalents and short-term investments, offset by $7.4 million of interest expense, $2.1 million in losses attributable to equity method investments, $2.0 million loss on impairment of strategic investment, $2.0 million in foreign currency transaction losses, and $1.3 million loss on extinguishment of debt.
+Added: Other income, net for 2023 consisted primarily of $21.2 million of interest income earned on our cash equivalents and short-term investments, and $1.5 million in foreign currency transaction gains, partially offset by $9.9 million of interest expense which included $3.3 million of additional interest as discussed above and the amortization of debt issuance costs related to our Convertible Senior Notes.
Income Tax Expense
7 unchanged sentences
We expect to rely on these sources of cash, primarily from product sales, to fund our material cash requirements in both the short and long term.
−Removed: The following table shows a summary of our cash flows for the years ended December 31, 2023, 2022 and 2021 (in thousands):
+Added: The following table shows a summary of our cash flows for the twelve months ended December 31, 2024, 2023, and 2022 (in thousands):
Year Ended December 31,
6 unchanged sentences
Net increase (decrease) in cash and cash equivalents
+Added: $ 10,366 $ (113,649) $ 101,336
Operating activities .
−Removed: Net cash used in operating activities was $31.8 million for the year ended December 31, 2023, compared to cash provided by operating activities of $50.5 million and $111.4 million, respectively, for the years ended December 31, 2022 and 2021.
−Removed: The reduction in net cash provided by operating activities for 2023 compared to 2022 was primarily a result of the $128.0 million increase in net loss, offset by increase of $58.8 million net non-cash adjustments.
−Removed: Net non-cash adjustments were primarily related to acquired in-process research and development expenses, operating lease termination and impairment charges and stock-based compensation expense.
−Removed: In addition, a net decrease of $17.7 million in changes of working capital balances.
−Removed: Changes of working capital balances primarily consisted of increases in inventories, prepaid and other current assets, and deferred revenue.
−Removed: Inventories increased to $157.9 million at December 31, 2023 from $111.1 million at December 31, 2022, primarily due to a return to target stocking levels post-pandemic as supply chain constraints subsided, as well as the scaling up of inventory to meet anticipated demand for Tandem Mobi.
−Removed: The reduction in net cash provided by operating activities for 2022 compared to 2021 was primarily a result of the $110.2 million increase in net loss, as well as net working capital changes.
−Removed: Working capital changes during 2022, primarily consisted of increases in inventories, accounts receivable, accounts payable, and operating leases and other current liabilities.
+Added: Net cash provided by operating activities was $24.2 million for the year ended December 31, 2024, compared to net cash used in operating activities of $31.8 million for the year ended December 31, 2023.
+Added: The increase in net cash provided by operating activities for 2024 compared to 2023 was primarily a result of the $128.8 million decrease in net loss, offset by a decrease of $76.5 million net non-cash adjustments.
+Added: Net non-cash adjustments in 2023 were primarily related to acquired in-process research and development expenses, operating lease termination and impairment charges and stock-based compensation expense.
+Added: In addition, there was a net decrease of $3.7 million in changes of working capital balances.
+Added: Changes of working capital balances primarily consisted of decreases in deferred revenue, current liabilities and inventories, offset by increases to accounts receivable.
Investing activities .
−Removed: Net cash used in investing activities was $85.7 million for the year ended December 31, 2023, which primarily consisted of $69.5 million cash paid for the acquisition of AMF Medical, including transaction costs (see Note 12, “Acquisitions”), $26.8 million in purchases of property and equipment of which $8.7 million was associated with improvements to the now completed new Headquarters lease facility (see Note 6, “Leases”), and $24.8 million cash paid for purchases of intangible assets and strategic investments, offset by $35.4 million provided by short-term investments activity as proceeds from maturities and redemptions exceeded purchases.
−Removed: Net cash provided by investing activities was $33.2 million for the year ended December 31, 2022, which primarily consisted of $101.8 million provided by short-term investments activity as proceeds from maturities and redemptions exceeded purchases, offset by $34.1 million in purchases of property and equipment, $25.7 million for the acquisition of Capillary Biomedical, including $1.0 million of transaction costs, and $8.9 million cash paid for purchases of intangible assets and strategic investments.
−Removed: Net cash used by investing activities was $186.9 million for the year ended December 31, 2021, which primarily consisted of $163.4 million used by short-term investments activity as purchases exceeded maturities and redemptions, $14.2 million in purchases of property and equipment, and $9.3 million cash paid for purchases of intangible assets and strategic investments.
+Added: Net cash used in investing activities was $23.5 million for the year ended December 31, 2024, which primarily consisted of $46.4 million cash paid for investments in equity method investees, $19.2 million in purchases of property and equipment, offset by $42.2 million provided by short-term investments activity as proceeds from maturities and redemptions exceeded purchases.
+Added: Net cash used in investing activities was $85.7 million for the year ended December 31, 2023, which primarily consisted of $69.5 million cash paid for the acquisition of AMF Medical, including transaction costs (see Note 12, “Acquisitions”), $26.8 million in purchases of property and equipment, and $24.8 million cash paid for purchases of intangible assets and strategic investments, offset by $35.4 million provided by short-term investments activity.
Financing activities .
+Added: Net cash provided by financing activities was $8.4 million for the year ended December 31, 2024, which primarily consisted of net proceeds of $306.9 million from the issuance of the 2029 Notes which was partially offset by $246.1 million used in the repurchase of 2025 Notes, $30.0 million used in the repurchase and retirement of common stock and $15.8 million used to purchase Capped Call Options related to the 2029 Notes.
+Added: In addition, $6.7 million was used in payments for tax withholdings related to the issuance of common stock under our stock plans, net of proceeds received from common stock issuances for the period.
Net cash provided by financing activities was $4.1 million for the year ended December 31, 2023, which primarily consisted of proceeds from the issuance of common stock under our stock plans, net of payments for related tax withholdings.
−Removed: Net cash provided by financing activities was $16.9 million and $51.9 million, respectively, for the years ended December 31, 2022 and 2021, which primarily consisted of proceeds from the issuance of common stock under our stock plans, net of payments for related tax withholdings.
−Removed: The reduction in proceeds from the issuance of common stock under our stock plans was primarily due to the decrease in the market price of our common stock and fewer employee stock options exercised.
Our liquidity position and capital requirements are subject to fluctuation based on a number of factors.
4 unchanged sentences
• the timing and amount of proceeds from the issuance of equity awards pursuant to employee stock plans;
−Removed: • fluctuations in gross margins and operating margins;
+Added: • fluctuations in gross and operating margins;
• fluctuations in working capital, including changes in accounts receivable, inventories, accounts payable, employee-related liabilities, and operating lease liabilities.
1 unchanged sentence
• support of our commercialization efforts related to our current and future products;
−Removed: • expansion of our customer support resources for our growing installed customer base;
+Added: • expansion of our commercial resources for our growing installed customer base;
• research and product development efforts, including clinical trial costs;
−Removed: • acquisitions, including contingent earnout payments that become payable upon the achievement of certain milestones;
+Added: • acquisitions, including strategic investments, equity method investments and future contingent payments associated with acquisitions;
• leasing or licensing of equipment, technology, intellectual property and other assets;
4 unchanged sentences
Convertible Senior Notes
−Removed: In May 2020, we entered into a purchase agreement with certain counterparties for the sale of an aggregate of $287.5 million principal amount of 1.50% Convertible Senior Notes due 2025 in a private offering to qualified institutional buyers (the Notes).
+Added: In March 2024, we completed an offering of $316.3 million aggregate principal amount of 1.50% Convertible Senior Notes due 2029 (the 2029 Notes).
+Added: The proceeds from the issuance of the 2029 Notes were $306.8 million, net of debt issuance costs and cash used to pay the cost of certain capped call transactions (see Note 7, “Debt”).
+Added: The Company used approximately $246.1 million of the net proceeds to repurchase approximately $246.7 million in aggregate principal amount of its Convertible Senior Notes Due 2025 (the 2025 Notes) concurrently with the pricing of the 2029 Notes.
+Added: The 2029 Notes are the Company’s senior unsecured obligations.
+Added: Interest is payable in cash semi-annually in arrears on March 15 and September 15 of each year beginning on September 15, 2024, at a rate of 1.50% per year.
+Added: The 2029 Notes mature on March 15, 2029 unless repurchased, redeemed, or converted in accordance with their terms prior to the maturity date.
+Added: In May 2020, we entered into a purchase agreement with certain counterparties for the sale of an aggregate of $287.5 million principal amount of 1.50% Convertible Senior Notes due 2025.
The proceeds from the issuance of the Notes were $244.6 million, net of debt issuance costs and cash used to pay the cost of the Capped Call Transactions (see Note 7, “Debt”).
−Removed: The Notes are senior unsecured obligations.
−Removed: Interest is payable in cash semi-annually in arrears on May 1 and November 1 at a rate of 1.50% per year.
−Removed: The Notes mature on May 1, 2025 unless repurchased, redeemed, or converted in accordance with their terms before the maturity date.
Cash payments due by calendar year for our Convertible Senior Notes at December 31, 2024, are as follows (in thousands):
−Removed: Total 2024 2025
−Removed: Principal amount of convertible senior notes (1)
2025 2026 2027 2028 2029
+Added: Principal amount (1) :
+Added: Convertible Senior Notes Due 2025
+Added: $ 40,760 $ 40,760 $ — $ — $ — $ —
+Added: Convertible Senior Notes Due 2029
+Added: 316,250 — — — — 316,250
+Added: Total principal amount
+Added: 357,010 40,760 — — — 316,250
Contractual interest
−Removed: Total $ 293,969 $ 4,313 $ 289,656
+Added: 20,270 5,050 4,744 4,744 4,744 988
+Added: $ 377,280 $ 45,810 $ 4,744 $ 4,744 $ 4,744 $ 317,238
(1) The convertible senior notes may be settled in cash, shares of our common stock, or a combination of cash and shares of our common stock, at our election.
7 unchanged sentences
At December 31, 2024, $4.8 million was included as a component of other long-term liabilities on the consolidated balance sheet.
−Removed: Critical Accounting Policies Involving Management Estimates and Assumptions
+Added: Critical Accounting Estimates
Our discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States.
4 unchanged sentences
While our significant accounting policies are more fully described in Note 2 “Summary of Significant Accounting Policies” to our consolidated financial statements included in this Annual Report, we believe that the following accounting policies are the most critical to the judgments and estimates used in the preparation of our consolidated financial statements.
−Removed: Revenue Recognition
−Removed: Our revenue is generated primarily from sales of our insulin pumps, single-use insulin cartridges and infusion sets to individual customers with third-party insurance coverage and through a network of distributors that resell the products to insulin-dependent diabetes customers.
−Removed: We are paid directly by customers who use the products, distributors and third-party insurance payors.
−Removed: We recognize revenue when control of our products is transferred to our customers in an amount that reflects the consideration we expect to receive from our customers in exchange for those products, net of estimated returns and rebates.
−Removed: This process involves identifying the contract with a customer, determining the performance obligations in the contract, determining the contract price, allocating the contract price to the distinct performance obligations in the contract, and recognizing revenue when the performance obligations have been satisfied.
−Removed: Revenue recognition for contracts with multiple performance obligations is based on the separate satisfaction of each distinct performance obligation within the contract.
−Removed: A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract.
−Removed: We consider a performance obligation satisfied once we have transferred control of a product to the customer, meaning the customer has the ability to direct the use of and obtain the benefit from the product.
−Removed: Complementary products, such as the t:connect, Tandem Source and the Tandem Device Updater, are considered distinct performance obligations satisfied over time, as access and support for these products is provided throughout the typical four-year warranty period of the insulin pumps.
−Removed: Accordingly, revenue related to the complementary products is deferred and recognized over a four-year period.
−Removed: When there is no standalone value for the complementary product, we determine its value by applying the expected cost plus a margin approach and then allocate the residual to the insulin pumps.
−Removed: For purposes of evaluating the Tandem Choice Program, we have determined that the ability for a customer to upgrade to a new technology, represents a material right because the pricing inherent in such option provides the customer with a discount that is incremental to the range of discounts that would otherwise be granted for the related goods and services to comparable customers.
−Removed: The standalone selling price for the Choice Right was estimated based on the adjusted market assessment approach and contemplates the likelihood that the respective option will be exercised.
Warranty Reserve
3 unchanged sentences
Warranty costs are estimated primarily based on the current expected product replacement cost and expected replacement rates utilizing historical experience.
−Removed: Experience has shown that initial data for any given pump version or pump platform may be insufficient;
−Removed: therefore, our process relies on long-term historical averages until sufficient data are available.
−Removed: As actual experience becomes available, we use the data to update the historical averages.
+Added: Experience has shown that initial data for any new pump version or pump platform may be insufficient.
+Added: Therefore, our process relies on long-term historical replacement data from existing platforms until sufficient data is available.
+Added: As actual experience accumulates, we adjust the warranty reserve estimate accordingly.
+Added: In addition, the availability of replacement data may differ by country due to local compliance and privacy regulations, which may require us to estimate the warranty liability using available information or data from similar markets.
Changes to the actual replacement rates or the expected product replacement cost could cause a material increase or decrease to our estimated warranty reserve and related cost of goods sold.
−Removed: We may make further adjustments to the warranty reserve when deemed appropriate, giving additional consideration to the length of time each pump version has been in the field and revised future expectations of performance based on new features and capabilities that may become available through Tandem Device Updater.
−Removed: Significant judgment is required in determining our provision for income taxes, deferred tax assets and liabilities and the valuation allowance recorded against net deferred tax assets.
−Removed: We use the asset and liability approach to recognize deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amounts and the tax bases of assets and liabilities.
−Removed: Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized.
−Removed: A valuation allowance is established when it is more likely than not the future realization of all or some of the deferred tax assets will not be achieved.
−Removed: Significant judgment is required to evaluate the need for a valuation allowance.
−Removed: The evaluation of the need for a valuation allowance is performed on a jurisdiction-by-jurisdiction basis, and includes a review of all available positive and negative evidence.
−Removed: Factors reviewed include determination of cumulative pre-tax book income after permanent differences, projections of pre-tax book income for the foreseeable future, earnings history, and reliability of forecasting.
−Removed: We will continue to assess the need for a valuation allowance on our deferred tax assets by evaluating both positive and negative evidence that may exist.
−Removed: Changes in the recognition or measurement of valuation allowance could result in material increases or decreases in our income tax expense in the period in which we make a change, which could have a material impact on our effective tax rate and operating results.
−Removed: Utilization of our net operating loss and research credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations provided by Section 382 of the Internal Revenue Code of 1986, as amended, and similar state provisions.
−Removed: The annual limitations may result in the expiration of net operating loss carryforwards before utilization.
−Removed: We have completed analyses through December 31, 2022 to determine whether our net operating losses and credits are likely to be limited by Section 382.
−Removed: Based on this study, we determined that an ownership change, as defined under Section 382, occurred in 2018 and the resulting limitation significantly reduced our ability to utilize our net operating loss and credit carryovers before they expire.
−Removed: As a result, in 2019 we reduced our deferred tax assets for the net operating loss and research credit carryforwards that were projected to expire unused with a corresponding offset to the valuation allowance recorded against such assets.
−Removed: Additionally, future ownership changes under Section 382 may also limit our ability to fully utilize any remaining tax benefits.
−Removed: We recognize liabilities for uncertain tax positions using a two-step approach.
−Removed: The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any.
−Removed: The second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon settlement.
−Removed: While we believe we have appropriate support for the positions taken on our tax returns, we regularly assess the potential outcomes of examinations by tax authorities in determining the adequacy of our provision for income taxes.
−Removed: We continually assess the likelihood and amount of potential revisions and adjust the income tax provision, income taxes payable and deferred taxes in the period in which the facts that give rise to a revision become known.
+Added: We may make further adjustments to the warranty reserve when appropriate, considering revised expectations of product performance based on enhanced hardware, or new features and capabilities that may become available through Tandem Device Updater.
Critical Accounting Policies
13 unchanged sentences
Acquisition-related Contingent Consideration
−Removed: In connection with our acquisition of AMF Medical SA completed in January of 2023 (see Note 12, “Acquisitions” to the consolidated financial statements in Part II, Item 8 of this Annual Report), the total consideration includes cash paid at the closing of the transaction and additional contingent earnout payments.
−Removed: The additional earnout payments of up to CHF 129.6 million, in aggregate, become payable upon the achievement of certain milestones and are comprised of a payment of up to CHF 38.4 million upon the successful completion of key development milestones over the two years following the acquisition, and a payment of up to CHF 91.2 million upon obtaining regulatory clearance of an automated controller enabled (ACE) pump by the United States Food and Drug Administration.
−Removed: Off-Balance Sheet Arrangements
−Removed: As of December 31, 2023, we are party to a standby letter of credit arrangement in support of certain operating lease obligations (See Note 13 “Commitments and Contingencies” to the consolidated financial statements in Part II, Item 8 of this Annual Report).
+Added: In connection with our acquisition of AMF Medical SA completed in January of 2023, the total consideration included cash paid at the closing of the transaction and additional contingent earnout payments (see Note 12, “Acquisitions” to the consolidated financial statements in Part II, Item 8 of this Annual Report for additional information).
+Added: Standby Letter of Credit
+Added: As of December 31, 2024, we were party to a standby letter of credit arrangement in support of certain operating lease obligations (See Note 13 “Commitments and Contingencies” to the consolidated financial statements in Part II, Item 8 of this Annual Report).
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.