PART I. FINANCIAL INFORMATION This part provides an overview of the company's financial performance and position, including statements and management's discussion [Item 1. Financial Statements](index=2&type=section&id=Item%201%20Financial%20Statements) This section presents the company's unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with detailed notes explaining accounting policies, specific financial items, and significant transactions for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position at specific dates, detailing assets, liabilities, and equity | Balance Sheet Item (in thousands) | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :------------ | :---------------- | :----- | | Total Assets | $875,736 | $967,658 | $(91,922) | | Cash and cash equivalents | $64,112 | $69,234 | $(5,122) | | Short-term investments | $251,249 | $369,095 | $(117,846) | | Accounts receivable, net | $128,443 | $114,585 | $13,858 | | Inventories | $142,573 | $149,612 | $(7,039) | | Total Liabilities | $742,453 | $704,560 | $37,893 | | Total Stockholders' Equity | $133,283 | $263,098 | $(129,815) | | Accumulated Deficit | $(1,230,781) | $(1,047,825) | $(182,956) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's financial performance over specific periods, including sales, gross profit, and net loss | Metric (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (YoY) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (YoY) | | :-------------------------------------- | :------------------------------- | :------------------------------- | :----------- | :------------------------------- | :------------------------------- | :----------- | | Sales | $240,678 | $221,910 | +8.5% | $475,100 | $413,584 | +14.9% | | Gross profit | $125,855 | $112,794 | +11.6% | $244,262 | $207,466 | +17.7% | | Gross margin | 52% | 51% | +1 pp | 51% | 50% | +1 pp | | Operating loss | $(51,810) | $(30,774) | -68.4% | $(172,688) | $(72,452) | -138.4% | | Net loss | $(52,400) | $(30,814) | -70.0% | $(182,956) | $(73,529) | -148.8% | | Net loss per share - basic and diluted | $(0.78) | $(0.47) | -66.0% | $(2.74) | $(1.13) | -142.5% | - Operating expenses for the six months ended June 30, 2025, increased significantly by **$137.1 million**, primarily due to a **$75.2 million** charge for acquired in-process R&D and a **$20.0 million** litigation and settlement expense[167](index=167&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This section details changes in stockholders' equity, including contributions, distributions, and net loss | Stockholders' Equity Item (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :----------------------------- | :----------------------------- | | Balance at December 31 | $263,098 | $313,632 | | Stock-based compensation expense | $51,090 | $46,537 | | Foreign currency translation gains | $5,979 | $(863) | | Net loss | $(182,956) | $(73,529) | | Balance at June 30 | $133,283 | $233,875 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section reports cash generated and used across operating, investing, and financing activities | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(27,774) | $(13,271) | | Net cash provided by (used in) investing activities | $67,316 | $(8,596) | | Net cash used in financing activities | $(44,401) | $10,584 | | Net increase (decrease) in cash and cash equivalents | $(5,122) | $(11,171) | | Cash and cash equivalents at end of period | $64,112 | $47,697 | - Investing activities in H1 2025 were primarily driven by **$146.4 million** from maturities and redemptions of short-term investments, offset by **$43.5 million** paid for acquired in-process R&D and **$26.5 million** in purchases of short-term investments[177](index=177&type=chunk) - Financing activities in H1 2025 included **$40.6 million** for principal payments on 2025 Notes and payments for tax withholdings related to stock plans, while H1 2024 included **$306.9 million** from 2029 Notes issuance, partially offset by 2025 Notes repurchase and capped call payments[178](index=178&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section explains accounting policies and specific financial items in the consolidated financial statements [1. Organization and Basis of Presentation](index=9&type=section&id=1.%20Organization%20and%20Basis%20of%20Presentation) This note describes the company's business and the foundational principles for financial statement preparation - Tandem Diabetes Care manufactures and sells advanced automated insulin delivery systems, including t:slim X2 and Tandem Mobi, both featuring Control-IQ+ technology[23](index=23&type=chunk)[24](index=24&type=chunk) - The company's durable insulin pump products generally have an expected lifespan of at least four years, complemented by sales of single-use components like cartridges and infusion sets[24](index=24&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods applied in the preparation of the financial statements - No material changes to accounting policies in H1 2025, except for the addition of derivatives and hedging activities[28](index=28&type=chunk) - The company capitalized **$13.3 million** as an intangible asset for a patent license from Roche, amortizing it over **seven years**, while expensing the remaining settlement consideration as litigation expense[35](index=35&type=chunk) - Revenue from complementary products (data management, software updates) is deferred and recognized over the typical four-year warranty period of insulin pumps[42](index=42&type=chunk) - The Tandem Choice program, which allowed eligible t:slim X2 customers to switch to Tandem Mobi, ended on December 31, 2024, with remaining deferrals recognized as revenue at that time[44](index=44&type=chunk)[45](index=45&type=chunk) [3. Short-Term Investments](index=14&type=section&id=3.%20Short-Term%20Investments) This note provides details on the company's short-term investment portfolio, including types and fair values | Short-Term Investments (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | United States Government-sponsored enterprises | $106,009 | $133,280 | | United States Treasury securities | $72,803 | $103,702 | | Commercial paper | $1,725 | $23,264 | | Corporate debt securities | $70,712 | $105,836 | | Foreign government bonds | — | $3,013 | | Total Estimated Fair Value | $251,249 | $369,095 | - All marketable securities are classified as short-term investments based upon the company's ability and intent to use them to satisfy liquidity requirements[60](index=60&type=chunk) [4. Composition of Certain Financial Statement Items](index=15&type=section&id=4.%20Composition%20of%20Certain%20Financial%20Statement%20Items) This note provides a breakdown of specific balance sheet items, such as accounts receivable and inventories | Item (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------ | :------------ | :---------------- | | Accounts receivable, net | $128,443 | $114,585 | | Inventories | $142,573 | $149,612 | | Allowance for Credit Losses (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :----------------------------- | :----------------------------- | | Balance at beginning of period | $7,251 | $4,898 | | Provision for expected credit losses | $3,577 | $3,723 | | Write-offs and adjustments, net | $(4,733) | $(3,396) | | Balance at end of period | $6,095 | $5,225 | [5. Fair Value Measurements](index=16&type=section&id=5.%20Fair%20Value%20Measurements) This note details the fair value hierarchy and measurements for financial assets and liabilities | Fair Value Measurements (in thousands) | June 30, 2025 Total | Level 1 | Level 2 | Level 3 | | :------------------------------------- | :------------------ | :------ | :------ | :------ | | **Assets:** | | | | | | Cash equivalents | $53,993 | $53,993 | $— | $— | | Available-for-sale securities | $251,249 | $72,803 | $178,446 | $— | | **Liabilities:** | | | | | | Foreign exchange forward contracts | $612 | $— | $612 | $— | | Fair Value of Debt (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Convertible Senior Notes due 2025 | $— | $39,130 | | Convertible Senior Notes due 2029 | $304,514 | $407,752 | | Total fair value | $304,514 | $446,882 | [6. Leases](index=17&type=section&id=6.%20Leases) This note provides information on the company's lease arrangements, including costs and impairment charges - The company recorded a **$3.6 million** impairment charge in Q1 2025 for the sublease of its Headquarters Lease Phase II, as expected sublease income was less than the right-of-use asset's net book value[75](index=75&type=chunk) - An additional **$3.1 million** impairment charge was recognized in Q1 2025 due to the relocation of development activities from Lausanne, Switzerland, and revised assumptions for the Vista Sorrento lease[76](index=76&type=chunk) | Lease Cost (in thousands) | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :------------------------ | :------------------------------- | :----------------------------- | | Operating lease cost (excluding sublease income) | $4,304 | $8,523 | | Loss on lease termination and right-of-use asset impairment charges | $— | $6,697 | | Sublease income, gross | $(566) | $(1,132) | | Total lease cost | $3,849 | $14,206 | [7. Debt](index=19&type=section&id=7.%20Debt) This note details the company's debt instruments, including convertible senior notes and related transactions - In March 2024, the company issued **$316.3 million** in 2029 Convertible Senior Notes and used **$246.1 million** of the proceeds to repurchase 2025 Notes, incurring a **$1.3 million** loss on extinguishment of debt[79](index=79&type=chunk)[80](index=80&type=chunk) - The 2025 Convertible Senior Notes matured in Q2 2025, and the remaining **$40.8 million** balance was settled using existing cash balances[87](index=87&type=chunk) | Convertible Senior Notes (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------------- | :------------ | :---------------- | | 2025 Notes Principal Amount | $— | $40,760 | | 2029 Notes Principal Amount | $316,250 | $316,250 | | Total debt, net | $309,146 | $348,936 | - The company entered into 2029 Capped Call Transactions at a net cost of **$15.8 million**, expected to reduce potential dilution upon conversion of the 2029 Notes[91](index=91&type=chunk) [8. Stockholders' Equity](index=21&type=section&id=8.%20Stockholders'%20Equity) This note details stockholders' equity components, including shares reserved and stock-based compensation | Shares Reserved for Future Issuance (in thousands) | June 30, 2025 | | :----------------------------------------------- | :------------ | | Conversion of Convertible Senior Notes | 9,335 | | Outstanding warrants | 194 | | Outstanding stock options | 3,054 | | Unvested restricted stock units | 4,351 | | ESPP awards | 2,233 | | Future equity award grants | 328 | | Total | 19,495 | | Stock-Based Compensation Expense (in thousands) | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :-------------------------------------------- | :------------------------------- | :----------------------------- | | Cost of sales | $1,751 | $3,476 | | Selling, general and administrative | $16,544 | $32,919 | | Research and development | $7,347 | $14,735 | | Total stock-based compensation expense | $25,642 | $51,130 | [9. Derivatives](index=23&type=section&id=9.%20Derivatives) This note describes the company's use of derivative instruments, primarily for hedging foreign currency risk - The company uses foreign currency forward contracts to hedge forecasted international revenue and operating expenses, primarily in Euros, Swiss Francs, and Canadian dollars[100](index=100&type=chunk) - As of June 30, 2025, outstanding foreign currency forward contracts had a notional value of **$37.7 million** and an unrealized loss of **$0.6 million** for the three and six months ended June 30, 2025[102](index=102&type=chunk) [10. Employee Benefits](index=23&type=section&id=10.%20Employee%20Benefits) This note outlines the company's employee benefit plans, such as defined contribution plans - The company offers defined contribution plans, including a 401(k) plan for eligible U.S. employees, allowing voluntary contributions and discretionary company matching[103](index=103&type=chunk) [11. Income Taxes](index=23&type=section&id=11.%20Income%20Taxes) This note provides details on the company's income tax position, including pre-tax loss and valuation allowances | Income Tax (in thousands) | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :------------------------ | :------------------------------- | :----------------------------- | | Pre-tax loss | $(57,722) | $(179,811) | | Income tax benefit (expense) | $(5,322) | $3,145 | - The company maintains a full valuation allowance against its net deferred tax assets, based on the current assessment that future benefits are not more likely than not to be realized before expiration[106](index=106&type=chunk) [12. Business Segment and Geographic Information](index=24&type=section&id=12.%20Business%20Segment%20and%20Geographic%20Information) This note presents revenue breakdown by business segment and geographic region - The company operates as a single reportable segment: Insulin Pumps and Supplies, with the CEO evaluating performance based on consolidated financial data[107](index=107&type=chunk)[108](index=108&type=chunk) | Revenue (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (YoY) | | :--------------------- | :----------------------------- | :----------------------------- | :----------- | | United States | $320,841 | $286,472 | +12.0% | | Outside the United States | $154,259 | $127,112 | +21.4% | | Total Sales | $475,100 | $413,584 | +14.9% | | Revenue by Product (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (YoY) | | :-------------------------------- | :----------------------------- | :----------------------------- | :----------- | | Pump | $213,962 | $195,162 | +9.6% | | Supplies and other | $261,138 | $219,414 | +19.0% | | Total Sales | $475,100 | $413,584 | +14.9% | [13. Acquisitions](index=25&type=section&id=13.%20Acquisitions) This note details recent acquisition agreements and related accounting treatments - The company revised its AMF Medical acquisition agreement in January 2025, committing to pay **CHF 68 million**, with **CHF 40 million** paid upfront and **CHF 28 million** due in October 2025[116](index=116&type=chunk) - The **CHF 68 million** payment for AMF Medical was recognized as **$75.2 million** in acquired in-process research and development (IPR&D) expenses for the six months ended June 30, 2025[116](index=116&type=chunk)[171](index=171&type=chunk) [14. Commitments and Contingencies](index=25&type=section&id=14.%20Commitments%20and%20Contingencies) This note outlines significant commitments and potential contingent liabilities, including legal matters - The company resolved all actual or potential patent disputes with Roche through a Settlement, Mutual Release and Cross-License Agreement on May 21, 2025[119](index=119&type=chunk) - As of June 30, 2025, the company believes it is not currently a party to any legal proceedings, regulatory matters, or other disputes or claims for which a material loss was considered probable or for which the amount or range of loss was reasonably estimable[120](index=120&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, highlighting key business strategies, product portfolio developments, market trends, and a detailed comparison of financial performance for the three and six months ended June 30, 2025 and 2024. It also discusses liquidity, capital resources, and critical accounting policies [Overview](index=27&type=section&id=Overview) This section summarizes the company's business, products, and strategic initiatives - Tandem Diabetes Care offers t:slim X2 and Tandem Mobi insulin pumps with Control-IQ+ technology, expanding its U.S. addressable market to include type 2 diabetes patients requiring intensive insulin therapy[130](index=130&type=chunk)[131](index=131&type=chunk) - The Tandem Mobi, the world's smallest durable automated insulin delivery (AID) system, received CE Mark approval in May 2025, with commercial release scaled in the U.S. in H1 2024 and international launch activities underway[131](index=131&type=chunk) - The company's strategy includes enhancing existing pump platforms, developing the Sigi patch pump, extended wear infusion technology, and advancing algorithms towards fully closed-loop technology[136](index=136&type=chunk) - As of December 31, 2024, the company had over **480,000 in-warranty users**, with approximately **one-third** outside the United States, and renewal sales have become a meaningful opportunity and key growth driver[138](index=138&type=chunk) [Trends and Uncertainties Impacting Financial Results](index=29&type=section&id=Trends%20and%20Uncertainties%20Impacting%20Financial%20Results) This section discusses market trends, regulatory changes, and economic factors influencing financial performance - Sales of new products are subject to varying international regulatory clearance timelines, and delays or failure to receive approval could impact revenue and results of operations[141](index=141&type=chunk) - The company is implementing a multi-channel managed care strategy, serving Tandem Mobi customers through the pharmacy channel since Q1 2025 and preparing to offer t:slim X2 cartridges and infusion sets via pharmacy in Q4 2025[141](index=141&type=chunk) - Global economic and market uncertainty, including recessionary concerns, changes in discretionary spending, increased interest rates, and high inflation, have impacted customer purchasing decisions and distributor buying patterns[146](index=146&type=chunk) [Components of Results of Operations](index=30&type=section&id=Components%20of%20Results%20of%20Operations) This section explains the primary drivers and components of the company's revenue and expenses - Sales are primarily from insulin pumps and single-use components, with seasonality in the U.S. typically showing lowest sales in Q1 and highest in Q4 due to insurance deductibles[142](index=142&type=chunk) - Cost of sales includes raw materials, labor, manufacturing overhead, product training, royalties, freight, warranty reserves, and digital health platform support, with pumps generally having higher gross profit margins than supplies[144](index=144&type=chunk) - Litigation and settlement expense in Q2 2025 reflects costs from the cross-license agreement with F. Hoffmann-La Roche AG and its subsidiaries[147](index=147&type=chunk) - Acquired in-process research and development (IPR&D) expenses represent costs of external R&D projects acquired outside of business combinations that lack alternative future use, such as the AMF Medical acquisition[149](index=149&type=chunk) [Results of Operations - Three Months Ended June 30, 2025 and 2024](index=32&type=section&id=Results%20of%20Operations%20-%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section analyzes financial performance for the three-month periods, with year-over-year metric comparisons | Metric (in thousands) | Q2 2025 | Q2 2024 | Change (YoY) | | :-------------------- | :----------- | :----------- | :----------- | | Total Sales | $240,678 | $221,910 | +8.5% | | United States Sales | $170,209 | $156,711 | +8.6% | | Outside U.S. Sales | $70,469 | $65,199 | +8.1% | | Gross Profit | $125,855 | $112,794 | +11.6% | | Gross Margin | 52% | 51% | +1 pp | | Operating Expenses | $177,665 | $143,568 | +23.7% | | Litigation & Settlement Expense | $19,951 | $— | N/A | | Net Loss | $(52,400) | $(30,814) | -70.0% | - U.S. pump shipments increased to approximately **21,000** in Q2 2025 from **20,000** in Q2 2024, contributing to increased sales[154](index=154&type=chunk) - R&D expenses decreased to **$48.1 million** in Q2 2025 from **$49.3 million** in Q2 2024, primarily due to lower employee-related expenses as a result of restructuring activities that occurred in Q1 2025[160](index=160&type=chunk) [Results of Operations - Six Months Ended June 30, 2025 and 2024](index=34&type=section&id=Results%20of%20Operations%20-%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section analyzes financial performance for the six-month periods, with year-over-year metric comparisons | Metric (in thousands) | H1 2025 | H1 2024 | Change (YoY) | | :-------------------- | :----------- | :----------- | :----------- | | Total Sales | $475,100 | $413,584 | +14.9% | | United States Sales | $320,841 | $286,472 | +12.0% | | Outside U.S. Sales | $154,259 | $127,112 | +21.4% | | Gross Profit | $244,262 | $207,466 | +17.7% | | Gross Margin | 51% | 50% | +1 pp | | Operating Expenses | $416,950 | $279,918 | +49.0% | | Acquired IPR&D Expenses | $75,217 | $— | N/A | | Litigation & Settlement Expense | $19,951 | $— | N/A | | Net Loss | $(182,956) | $(73,529) | -148.8% | - U.S. pump shipments increased to over **38,000** in H1 2025 from nearly **36,000** in H1 2024, while international pump shipments grew to over **20,000** from approximately **19,000**[164](index=164&type=chunk)[165](index=165&type=chunk) - SG&A expenses for H1 2025 included one-time charges of **$6.7 million** for non-recurring facility impairment costs and **$2.2 million** for restructuring costs[168](index=168&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, funding sources, and ability to meet financial obligations - As of June 30, 2025, the company held **$315.4 million** in cash, cash equivalents, and short-term investments, which management believes is sufficient to fund ongoing core business activities for at least the next **12 months**[174](index=174&type=chunk) - Net cash used in operating activities increased to **$27.8 million** for the six months ended June 30, 2025, compared to **$13.3 million** for the same period in 2024[176](index=176&type=chunk) - Future capital needs are expected to include expenditures related to commercialization efforts, R&D, acquisitions, leasing, and investments for manufacturing and distribution[182](index=182&type=chunk) [Critical Accounting Policies](index=37&type=section&id=Critical%20Accounting%20Policies) This section highlights the accounting policies that require significant judgment and estimation - There have been no material changes to the company's critical accounting policies and estimates from the information provided in its Annual Report on Form 10-K for the year ended December 31, 2024[181](index=181&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that there were no material changes to the company's quantitative and qualitative disclosures about market risk, except for the initiation of foreign currency forward contracts to mitigate exchange rate fluctuations on international revenue and operating expenses - The company entered into foreign currency forward contracts to mitigate the impact of foreign currency exchange rate fluctuations on international revenue and operating expenses[183](index=183&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025. No material changes in internal control over financial reporting occurred during the quarter - Disclosure controls and procedures were deemed effective at a reasonable assurance level as of June 30, 2025[185](index=185&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[187](index=187&type=chunk) PART II. OTHER INFORMATION This part covers legal proceedings, risk factors, equity sales, and other required disclosures [Item 1. Legal Proceedings](index=39&type=section&id=Item%201%20Legal%20Proceedings) This item refers to the "Commitments and Contingencies - Legal and Regulatory Matters" section in Note 14 of the financial statements for details on legal proceedings - Legal proceedings information is detailed in Note 14, "Commitments and Contingencies," of the financial statements[189](index=189&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A%20Risk%20Factors) An investment in the company's securities involves a high degree of risk, including those related to business and industry, international operations, indebtedness, future financings, macroeconomic conditions, privacy and security, legal and intellectual property, regulatory environment, ESG matters, and other general risks. Several risk factors have been updated or newly introduced since the last Annual Report [Risks Related to Our Business and Our Industry](index=39&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Our%20Industry) This section outlines business and industry risks, including profitability challenges and competitive pressures - The company has an accumulated deficit of **$1.2 billion** as of June 30, 2025, and cannot assure sustained profitability[202](index=202&type=chunk)[205](index=205&type=chunk) - The business relies heavily on insulin pump sales, which are vulnerable to competition, technological breakthroughs, regulatory actions, and supply chain disruptions[206](index=206&type=chunk)[208](index=208&type=chunk) - Maintaining and growing revenue depends on retaining a high percentage of the customer base, which is challenged by competing products and changes in reimbursement[210](index=210&type=chunk)[211](index=211&type=chunk) - Manufacturing risks, including quality defects, supply chain issues, and inability to scale production, could negatively impact sales and operating margins[240](index=240&type=chunk)[242](index=242&type=chunk) [Risks Related to Our International Operations](index=39&type=section&id=Risks%20Related%20to%20Our%20International%20Operations) This section details international operation risks, such as regulatory differences and currency fluctuations - International operations, accounting for approximately **28%** of 2024 sales, face risks such as local product preferences, differing regulatory requirements, and more restrictive privacy laws like GDPR[254](index=254&type=chunk)[256](index=256&type=chunk) - Foreign currency fluctuations, particularly with the Canadian dollar, Euro, and Swiss franc, could increase operating expenses and reduce revenues, despite hedging efforts[287](index=287&type=chunk) [Risks Related to Our Indebtedness](index=39&type=section&id=Risks%20Related%20to%20Our%20Indebtedness) This section addresses risks from debt obligations, including repayment capacity and potential dilution - The company has incurred significant indebtedness, including **$316.3 million** in 2029 Convertible Senior Notes, which subjects it to required debt service payments and potential financial flexibility restrictions[259](index=259&type=chunk)[261](index=261&type=chunk) - The company's ability to service the 2029 Notes depends on future business operations and liquidity, and insufficient cash flow could necessitate reducing capital expenditures, selling assets, or seeking additional financing[263](index=263&type=chunk) - Conversion of the 2029 Notes, if settled with shares, will dilute existing stockholders' ownership and could negatively impact the common stock's trading price[266](index=266&type=chunk) [Risks Related to Our Future Financings and Financial Results](index=40&type=section&id=Risks%20Related%20to%20Our%20Future%20Financings%20and%20Financial%20Results) This section covers future financing risks and the inherent volatility of quarterly operating results - The company may need to raise additional funds through equity or debt offerings, or collaborations, which could lead to stockholder dilution or significant financing costs[273](index=273&type=chunk) - Operating results are expected to fluctuate significantly quarter-to-quarter due to factors like new product launches, regulatory clearances, competition, and reimbursement policies[275](index=275&type=chunk)[277](index=277&type=chunk) [Risks Related to Macroeconomic Conditions and External Factors](index=40&type=section&id=Risks%20Related%20to%20Macroeconomic%20Conditions%20and%20External%20Factors) This section discusses risks from macroeconomic and external factors, including trade policies and inflation - International trade policies, including tariffs and trade barriers, particularly between the U.S. and China/Mexico, could adversely affect the business by increasing costs and disrupting supply chains[279](index=279&type=chunk) - Global economic and political uncertainties, such as recessions, inflation, and military hostilities, could negatively impact consumer demand and affordability of products[284](index=284&type=chunk) - The effects of inflation, including higher interest rates, capital costs, and labor/shipping expenses, could negatively impact liquidity, financial condition, and results of operations[288](index=288&type=chunk) [Risks Related to Privacy and Security](index=40&type=section&id=Risks%20Related%20to%20Privacy%20and%20Security) This section highlights risks associated with data privacy, cybersecurity threats, and the use of AI technologies - The company processes personal data and is subject to numerous evolving data privacy and security obligations, including U.S. state laws (e.g., CCPA/CPRA) and international regulations (e.g., GDPR)[289](index=289&type=chunk)[290](index=290&type=chunk)[293](index=293&type=chunk)[294](index=294&type=chunk) - Cyberattacks, malicious activity, and vulnerabilities in information technology systems, software, and hardware (including third-party components) pose significant risks, potentially leading to security incidents, data breaches, and business disruptions[304](index=304&type=chunk)[305](index=305&type=chunk)[308](index=308&type=chunk)[309](index=309&type=chunk) - The use of Artificial Intelligence (AI) technologies by employees and the potential for sensitive information leakage or disclosure through third-party generative AI platforms introduce new compliance costs and risks[297](index=297&type=chunk)[316](index=316&type=chunk) [Risks Related to Legal and Intellectual Property](index=40&type=section&id=Risks%20Related%20to%20Legal%20and%20Intellectual%20Property) This section addresses intellectual property risks, including protection, enforcement, and potential litigation - The company relies on patents, trademarks, and trade secrets, but their protection is uncertain, facing risks of opposition, invalidation, or circumvention by competitors[318](index=318&type=chunk) - Patent litigation is common in the medical device industry, and the company may incur substantial costs and divert management attention defending against infringement claims or enforcing its own intellectual property rights[322](index=322&type=chunk)[323](index=323&type=chunk) [Risks Related to Our Regulatory Environment](index=40&type=section&id=Risks%20Related%20to%20Our%20Regulatory%20Environment) This section details risks from medical device regulations, product approvals, and healthcare reforms - The medical device industry is extensively regulated, and failure to comply with requirements for product design, development, testing, manufacturing, and marketing could lead to enforcement actions, fines, and business disruption[329](index=329&type=chunk)[331](index=331&type=chunk) - New products or modifications to existing ones may require new regulatory clearances (e.g., 510(k), PMA, CE Marks), and delays or disagreements with regulatory bodies could halt marketing or necessitate recalls[332](index=332&type=chunk)[336](index=336&type=chunk) - Product recalls or suspensions due to safety issues, defects, or malfunctions could significantly impact the company, diverting resources, harming reputation, and affecting financial results[337](index=337&type=chunk)[338](index=338&type=chunk) - Healthcare reforms (e.g., OBBBA, IRA 2022) and price controls, particularly in the EU, may lead to downward pressure on product prices and reduced reimbursement, adversely affecting revenue and profitability[346](index=346&type=chunk)[352](index=352&type=chunk) [Risks Related to Environmental, Social and Governance Matters](index=75&type=section&id=Risks%20Related%20to%20Environmental%2C%20Social%20and%20Governance%20Matters) This section covers risks related to evolving ESG regulations, reporting, and the impacts of climate change - Evolving ESG regulations and stakeholder expectations are increasing general and administrative costs and management time, with challenges in data collection, reporting, and supply chain compliance[355](index=355&type=chunk) - Climate change and extreme weather conditions pose potential long-term risks to the business, including disruptions to operations, supply chains, and increased compliance burdens from new regulations[357](index=357&type=chunk)[358](index=358&type=chunk) [Other Risks](index=40&type=section&id=Other%20Risks) This section includes general risks such as stock price volatility, employee retention, and anti-takeover provisions - The trading price of the common stock is highly volatile, influenced by financial results, product introductions, regulatory actions, and market dynamics, potentially affecting liquidity and capital raising[359](index=359&type=chunk)[360](index=360&type=chunk) - The company's success depends on retaining and motivating senior management and key employees, and competition for talent or labor shortages could adversely affect business expansion and growth[361](index=361&type=chunk)[362](index=362&type=chunk) - Anti-takeover provisions in organizational documents and Delaware law may delay or prevent a change of control, potentially reducing stock price and hindering stockholder actions[363](index=363&type=chunk)[365](index=365&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=72&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities or use of proceeds were reported[377](index=377&type=chunk) [Item 5. Other Information](index=72&type=section&id=Item%205.%20Other%20Information) There is no other information to report under this item - No other information is reported under this item[378](index=378&type=chunk) [Item 6. Exhibits](index=73&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Amended and Restated Certificate of Incorporation and Bylaws, the Settlement, Mutual Release and Cross-License Agreement with F. Hoffmann-La Roche AG, and certifications from the CEO and CFO - Key exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, the Settlement, Mutual Release and Cross-License Agreement with F. Hoffmann-La Roche AG, and Section 302 and 906 certifications from the CEO and CFO[380](index=380&type=chunk)

[Second Quarter 2025 Performance Overview](index=1&type=section&id=Second%20Quarter%202025%20Performance%20Overview) Tandem Diabetes Care achieved record Q2 2025 sales and improved gross margin, driven by product innovation and strong market performance, despite increased GAAP operating and net losses due to litigation settlement expenses [Key Operational Achievements](index=1&type=section&id=2.1.%20Key%20Operational%20Achievements) Tandem Diabetes Care achieved record Q2 2025 sales in US and international markets, improved gross margin, and made significant progress in product development and regulatory approvals - Achieved **record second-quarter sales** in both US and international markets[4](index=4&type=chunk) - Gross margin improved both year-over-year and quarter-over-quarter[4](index=4&type=chunk) - Launched an early access program in the US for the t:slim X2™ insulin pump integrated with the Abbott FreeStyle Libre® 3 Plus CGM sensor[4](index=4&type=chunk) - Tandem Mobi insulin delivery system received **CE Mark** approval[4](index=4&type=chunk) - Submitted a 510(k) application for extended wear of the SteadiSet infusion set[4](index=4&type=chunk) [Financial Results (Q2 2025 vs Q2 2024)](index=1&type=section&id=2.2.%20Financial%20Results%20(Q2%202025%20vs%20Q2%202024)) Q2 2025 saw global sales grow 8% to **$240.7 million**, with GAAP gross profit increasing to **$125.9 million** and gross margin to **52%**, while GAAP operating and net losses widened due to litigation settlement expenses Q2 2025 Key Financial Data Comparison (GAAP) | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | YOY Change (%) | | :--------------------- | :----------------------- | :----------------------- | :------------- | | Global Sales | 240.7 | 221.9 | 8% | | US Sales | 170.2 | 156.7 | 9% | | US Pump Shipments | ~21,000 units | - | Growth | | International Sales | 70.5 | 65.2 | 8% | | International Pump Shipments | ~9,000 units | - | - | | GAAP Gross Profit | 125.9 | 112.8 | 11.6% | | GAAP Gross Margin | 52% | 51% | 1% | | GAAP Operating Loss | (51.8) | (30.8) | 68.2% | | GAAP Net Loss | (52.4) | (30.8) | 70.1% | | GAAP Net Loss Per Share | (0.78) | (0.47) | 66% | Q2 2025 Non-GAAP Financial Data Comparison | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | YOY Change (%) | | :--------------------- | :----------------------- | :----------------------- | :------------- | | Non-GAAP Operating Loss | (31.9) | (30.9) | 3.2% | | Non-GAAP Operating Loss as % of Sales | -13% | -14% | 1% | | Non-GAAP Net Loss | (32.4) | (30.9) | 4.9% | | Adjusted EBITDA | (1.8) | (1.9) | -5.3% | | Adjusted EBITDA as % of Sales | -1% | -1% | 0% | [2025 Annual Financial Guidance](index=3&type=section&id=2025%20Annual%20Financial%20Guidance) Tandem Diabetes Care projects **$1 billion** in global sales for 2025, with a gross margin of **53% to 54%**, and an adjusted EBITDA margin revised to **negative 5%** due to Q1 IPR&D expenses and a policy change regarding non-GAAP adjustments 2025 Full-Year Financial Guidance | Metric | 2025 Full-Year Guidance | | :--------------------- | :------------- | | Global Sales | Approximately $1 billion | | US Sales | Approximately $700 million | | International Sales | Approximately $300 million | | Gross Margin | Approximately 53% to 54% | | Adjusted EBITDA Margin | Approximately negative 5% | | Non-Cash Expenses (Total) | Approximately $115 million | | - Stock-based Compensation | Approximately $95 million | | - Depreciation and Amortization | Approximately $20 million | - Adjusted EBITDA margin guidance revised from approximately **3%** to approximately **negative 5%**, reflecting an **8 percentage point impact** from acquired in-process research and development (IPR&D) expenses in Q1[9](index=9&type=chunk) - Effective Q2 2025, the company no longer adjusts for IPR&D expenses in non-GAAP results, aligning with SEC comments[9](index=9&type=chunk) [Non-GAAP Financial Measures and Program Updates](index=4&type=section&id=Non-GAAP%20Financial%20Measures%20and%20Program%20Updates) This section clarifies the company's non-GAAP financial measures, details the policy change regarding IPR&D expense adjustments, and confirms the conclusion of the Tandem Choice program [Non-GAAP Financial Measures Explanation](index=4&type=section&id=3.1.%20Non-GAAP%20Financial%20Measures%20Explanation) The company provides non-GAAP financial measures to aid investor understanding of financial performance and future prospects by excluding items unrelated to core operations - Non-GAAP financial measures are provided to help investors understand the company's financial results and assess future performance by excluding items unrelated to core operating results[10](index=10&type=chunk) - Non-GAAP financial measures may not be directly comparable to similar metrics used by other companies and should not be considered a substitute for GAAP measures[10](index=10&type=chunk) [IPR&D Expense Adjustment Policy Change](index=4&type=section&id=3.2.%20IPR%26D%20Expense%20Adjustment%20Policy%20Change) Tandem Diabetes Care adjusted for IPR&D expenses in Q1 2025 non-GAAP results but ceased this practice from Q2 onwards, revising 2025 guidance to align with SEC comments - In Q1 2025, the company included IPR&D expenses in non-GAAP financial adjustments[11](index=11&type=chunk) - Effective Q2 2025, the company no longer includes IPR&D expenses in non-GAAP results, aligning with SEC comments[11](index=11&type=chunk)[27](index=27&type=chunk) - 2025 performance and guidance have been revised to reflect this change[11](index=11&type=chunk) [Tandem Choice Program Conclusion](index=4&type=section&id=3.3.%20Tandem%20Choice%20Program%20Conclusion) The Tandem Choice program concluded in 2024, thus having no impact on 2025 sales or margins, having been implemented from September 2022 to December 2024 with complex accounting - The Tandem Choice program concluded in 2024, with no impact on 2025 sales or margins[6](index=6&type=chunk)[12](index=12&type=chunk)[23](index=23&type=chunk) - The program was implemented from September 2022 to December 2024, involving complex accounting for sales deferrals and revenue recognition[12](index=12&type=chunk) [Company Information and Disclosures](index=4&type=section&id=Company%20Information%20and%20Disclosures) This section provides an overview of Tandem Diabetes Care's mission and products, along with important disclaimers regarding forward-looking statements and associated risks [About Tandem Diabetes Care, Inc.](index=4&type=section&id=4.1.%20About%20Tandem%20Diabetes%20Care,%20Inc.) Tandem Diabetes Care is a global insulin delivery and diabetes technology company manufacturing and selling advanced automated insulin delivery systems to ease diabetes management - Tandem Diabetes Care is a global insulin delivery and diabetes technology company[14](index=14&type=chunk) - The company manufactures and sells advanced automated insulin delivery systems designed to ease the burden of diabetes management[14](index=14&type=chunk) - Key products include the Tandem Mobi system and t:slim X2 insulin pump, both featuring Control-IQ+ advanced hybrid closed-loop technology[14](index=14&type=chunk) [Forward-Looking Statements](index=5&type=section&id=4.2.%20Forward-Looking%20Statements) This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from expectations, with no obligation for the company to update them - This press release contains forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from expectations[16](index=16&type=chunk) - Risk factors include market acceptance, competition, international sales expansion, reimbursement policy changes, operational capabilities, product commercialization and development, regulatory approvals, and global economic conditions[16](index=16&type=chunk) - The company undertakes no obligation to update or revise any forward-looking statements[16](index=16&type=chunk) [Condensed Consolidated Financial Statements](index=6&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents the company's condensed consolidated balance sheets, statements of operations, sales by geography, and reconciliation of GAAP versus non-GAAP financial results [Condensed Consolidated Balance Sheets](index=6&type=section&id=5.1.%20Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets were **$875.7 million**, a decrease from **$967.7 million** at December 31, 2024, with total liabilities increasing to **$742.5 million** and stockholders' equity decreasing to **$133.3 million** Condensed Consolidated Balance Sheets (Excerpt) | Metric (thousand USD) | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------- | :------------- | | **Assets** | | | | Cash, Cash Equivalents and Short-Term Investments | 315,361 | 438,329 | | Accounts Receivable, Net | 128,443 | 114,585 | | Inventory | 142,573 | 149,612 | | Total Current Assets | 614,817 | 724,491 | | Total Assets | 875,736 | 967,658 | | **Liabilities and Stockholders' Equity** | | | | Accounts Payable, Accrued Expenses and Employee-Related Liabilities | 121,293 | 127,028 | | Total Current Liabilities | 251,690 | 247,049 | | Convertible Senior Notes, Net - Long-Term | 309,146 | 308,266 | | Total Liabilities | 742,453 | 704,560 | | Total Stockholders' Equity | 133,283 | 263,098 | | Total Liabilities and Stockholders' Equity | 875,736 | 967,658 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=5.2.%20Condensed%20Consolidated%20Statements%20of%20Operations) In Q2 2025, sales reached **$240.7 million** with a gross profit of **$125.9 million**, but operating and net losses widened to **$51.8 million** and **$52.4 million** respectively, primarily due to increased operating expenses including litigation settlement Condensed Consolidated Statements of Operations (Excerpt) | Metric (thousand USD) | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :-------------------------------- | :------------- | :------------- | :----------- | :----------- | | Sales | 240,678 | 221,910 | 475,100 | 413,584 | | Cost of Sales | 114,823 | 109,116 | 230,838 | 206,118 | | Gross Profit | 125,855 | 112,794 | 244,262 | 207,466 | | Selling, General and Administrative Expenses | 109,596 | 94,242 | 223,449 | 184,348 | | Litigation Settlement Expense | 19,951 | — | 19,951 | — | | Research and Development Expenses | 48,118 | 49,326 | 98,333 | 95,570 | | Acquired In-Process Research and Development Expenses | — | — | 75,217 | — | | Total Operating Expenses | 177,665 | 143,568 | 416,950 | 279,918 | | Operating Loss | (51,810) | (30,774) | (172,688) | (72,452) | | Net Loss | (52,400) | (30,814) | (182,956) | (73,529) | | Net Loss Per Share - Basic and Diluted | (0.78) | (0.47) | (2.74) | (1.13) | [Sales by Geography](index=8&type=section&id=5.3.%20Sales%20by%20Geography) Q2 2025 US sales grew **9%** to **$170.2 million**, with international sales up **8%** to **$70.5 million**, driven by growth in both pump and consumables categories across regions Sales by Geography (thousand USD) | Region/Product | Q2 2025 | Q2 2024 | % Change | YTD 2025 | YTD 2024 | % Change | | :-------------------- | :------------- | :------------- | :----- | :----------- | :----------- | :----- | | **US:** | | | | | | | | Pumps | 85,467 | 81,745 | 5% | 157,608 | 143,465 | 10% | | Consumables and Other | 84,742 | 74,812 | 13% | 163,233 | 143,999 | 13% | | **Total US GAAP Sales** | 170,209 | 156,711 | 9% | 320,841 | 286,472 | 12% | | **International:** | | | | | | | | Pumps | 26,404 | 26,130 | 1% | 56,354 | 51,697 | 9% | | Consumables and Other | 44,065 | 39,069 | 13% | 97,905 | 75,415 | 30% | | **Total International Sales** | 70,469 | 65,199 | 8% | 154,259 | 127,112 | 21% | | **Total Global GAAP Sales** | 240,678 | 221,910 | 8% | 475,100 | 413,584 | 15% | [Reconciliation of GAAP versus Non-GAAP Financial Results](index=9&type=section&id=5.4.%20Reconciliation%20of%20GAAP%20versus%20Non-GAAP%20Financial%20Results) The company provides a reconciliation of GAAP to non-GAAP financial measures, illustrating the impact of adjustments like litigation settlement, facility impairment, restructuring, and Tandem Choice on key financial metrics, noting IPR&D is no longer a non-GAAP adjustment from Q2 2025 Reconciliation of GAAP versus Non-GAAP Financial Results (Excerpt) | Metric (thousand USD) | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :-------------------------------- | :------------- | :------------- | :----------- | :----------- | | GAAP Sales | 240,678 | 221,910 | 475,100 | 413,584 | | Non-GAAP Sales | 240,678 | 221,756 | 475,100 | 414,576 | | GAAP Gross Profit | 125,855 | 112,794 | 244,262 | 207,466 | | Non-GAAP Gross Profit | 125,855 | 112,667 | 244,262 | 208,485 | | GAAP Operating Loss | (51,810) | (30,774) | (172,688) | (72,452) | | Litigation Settlement Expense Adjustment | 19,951 | — | 19,951 | — | | Non-Recurring Facility Impairment Cost Adjustment | — | — | 6,697 | — | | Restructuring Cost Adjustment | — | — | 4,470 | — | | Non-GAAP Operating Loss | (31,859) | (30,901) | (141,570) | (71,433) | | GAAP Net Loss | (52,400) | (30,814) | (182,956) | (73,529) | | Non-GAAP Net Loss | (32,449) | (30,941) | (151,838) | (72,510) | | Adjusted EBITDA | (1,851) | (1,896) | (81,762) | (16,346) | - Effective Q2 2025, the company no longer adjusts for IPR&D expenses in non-GAAP results, aligning with SEC comments[27](index=27&type=chunk)

Core Viewpoint - Tandem Diabetes Care, Inc. (TNDM) has experienced an 8.4% decline in share price over the past week, but the formation of a hammer chart pattern suggests potential support and a possible trend reversal in the future [1][2]. Technical Analysis - The hammer chart pattern indicates a minor difference between opening and closing prices, with a long lower wick, suggesting that the stock may have found support after a downtrend [4][5]. - This pattern typically signals that bears may have lost control, indicating a potential trend reversal if buying interest emerges [5]. Fundamental Analysis - There is rising optimism among Wall Street analysts regarding TNDM's future earnings, which supports the potential for a trend reversal [2][7]. - Over the last 30 days, the consensus EPS estimate for TNDM has increased by 0.6%, indicating that analysts expect better earnings than previously predicted [8]. - TNDM holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which historically outperform the market [9][10].

Core Viewpoint - Tandem Diabetes Care, Inc. (TNDM) has experienced a significant decline of 27% over the past four weeks, but it is now positioned for a potential trend reversal as it enters oversold territory, with analysts predicting better earnings than previously expected [1] Group 1: Technical Indicators - The Relative Strength Index (RSI) is a momentum oscillator that indicates whether a stock is oversold, with readings below 30 typically signaling this condition [2] - TNDM's current RSI reading is 19.31, suggesting that the heavy selling pressure may be exhausting, indicating a potential bounce back towards equilibrium [5] Group 2: Fundamental Indicators - There is a strong consensus among sell-side analysts that TNDM's earnings estimates for the current year have increased by 0.6% over the last 30 days, which often correlates with price appreciation [7] - TNDM holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the stock's potential for a turnaround [8]

Company Overview - Tandem Diabetes Care, Inc. (TNDM) has launched its t:slim X2 insulin pump with Control-IQ+ technology, now compatible with Abbott's FreeStyle Libre 3 Plus continuous glucose monitoring sensor in the U.S. An early access program has been initiated, with plans for broader availability in the second half of 2025 [1][9]. Stock Performance - Following the announcement of the new compatibility, TNDM's shares increased by 1.6%, reaching $20.55 [2]. However, over the past year, TNDM shares have experienced a decline of 49.4%, compared to a 14.8% decline in the industry [12]. Financial Metrics - Tandem Diabetes has a market capitalization of $1.35 billion and is projected to have an earnings per share (EPS) growth rate of 28.3% in 2025, significantly higher than the industry's expected growth of 13.8%. Revenue for 2025 is anticipated to rise by 10.6% [4]. Product Features - The t:slim X2 insulin pump utilizes advanced hybrid closed-loop technology, adjusting insulin delivery every five minutes based on predicted glucose values. It features the unique AutoBolus function, which calculates and delivers correction boluses for missed meals [5]. The FreeStyle Libre 3 Plus sensor offers a 15-day wear time and transmits glucose readings every minute to the t:slim mobile app [6]. Industry Insights - The global insulin delivery device market was valued at $16.43 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 7.9% by 2027, driven by the increasing prevalence of diabetes and advancements in technology [7][10]. Strategic Developments - Tandem Diabetes has entered an agreement to develop integrated diabetes solutions that will combine Abbott's future dual glucose-ketone sensor with Tandem's insulin delivery systems, enhancing options for diabetes management [11].

Summary of Tandem Diabetes Conference Call Company Overview - **Company**: Tandem Diabetes - **Key Executives**: President and CEO, Susan Morrison (Senior Vice President and Chief Administrative Officer) Recent Performance - **2024 Growth**: Guided for 10% growth but achieved 18% growth, marking the highest fourth quarter performance ever [4][5] - **Q1 Performance**: Q1 growth exceeded 20%, driven by strong demand and the introduction of new products [9][20] Product Developments - **Tandem Mobi**: A smaller, discreet device utilizing Control IQ technology, leading to double-digit growth in MDI starts since its launch [6][7] - **Type 2 Approval**: Received approval for Type 2 diabetes management, with expectations for meaningful growth in the coming years [8][15] - **Pharmacy Channel**: Plans to fully leverage the pharmacy channel, which is expected to enhance accessibility and profitability [8][66] Market Dynamics - **Competitive Landscape**: Anticipated disruption from a competitor separating their diabetes business, but Tandem believes its pipeline and initiatives will maintain competitive advantage [18][19] - **Type 2 Market Potential**: Approximately 2.3 million people in the U.S. with insulin-intensive Type 2 diabetes, with only about 100,000 currently using pumps, indicating significant growth potential [30][31] Sales Strategy - **Sales Force Expansion**: Ongoing evaluation of sales force size and market access strategies, particularly for Type 2 diabetes management [34][36] - **Pharmacy Channel Strategy**: Focus on increasing covered lives and establishing contracts to enhance market access [70][72] Financial Outlook - **Gross Margin Expectations**: Anticipated increase from 51% to 54% for the year, with long-term targets of 60% gross margin by 2026 [78][82] - **Operational Efficiency**: Initiatives in place to improve operating margins while expanding sales force and entering new markets [80][86] Pipeline and Future Developments - **Integration with CGMs**: Ongoing integration of new technologies, including the FreeStyle Libre 3, to enhance product offerings [46][48] - **AdaNet Algorithm**: Collaboration with UVA to develop a new algorithm aimed at improving diabetes management [54][61] Key Takeaways - **Market Awareness**: Increased awareness of AID systems among Type 2 diabetes patients is expected to drive steady growth [32][33] - **Long-term Strategy**: Tandem is focused on a portfolio approach to address diverse market needs, ensuring a competitive edge through innovation and technology [40][43] Conclusion - Tandem Diabetes is positioned for significant growth driven by innovative product offerings, strategic market expansions, and a focus on improving patient access through pharmacy channels. The company is optimistic about its future performance and market potential, particularly in the Type 2 diabetes segment.

Tandem Diabetes Care (TNDM) Conference Summary Company Overview - **Company**: Tandem Diabetes Care (TNDM) - **Industry**: Diabetes management technology, specifically insulin delivery systems Key Points and Arguments Market Expansion - Tandem has expanded its focus from primarily Type 1 diabetes to include Type 2 diabetes, which has more than doubled its addressable market in the U.S. [4][7] - The company is also exploring opportunities in the pharmacy channel, which could enhance revenue and margins [5][21] Product Offerings - Tandem's product portfolio includes the t:slim and Mobi insulin pumps, with Mobi designed to attract new users, particularly in the pediatric population [10][12] - Mobi has seen double-digit growth in new pump starts, particularly among those transitioning from multiple daily injections (MDI) [12][14] Pipeline Developments - Upcoming products include enhancements to Mobi and the introduction of the SIGI pump, which will offer tubeless functionality [15][17] - The company plans to share updates on its Control IQ study at the upcoming ADA conference, which could further validate its technology [19][20] Financial Outlook - Tandem aims for gross margins of 60% by 2026, with a long-term goal of 65% [21][22] - The introduction of Mobi and its lower cost profile, along with pharmacy channel penetration, are expected to drive margin improvements [23][24] Sales Strategy - Tandem is transitioning to a direct sales model in select international markets, which is anticipated to improve margins and market penetration [27][30] - The company has been expanding its sales force in the U.S. to enhance market awareness and support for physicians prescribing insulin pumps [50][51] Competitive Landscape - The competitive dynamics may shift with Medtronic's business changes, but Tandem remains confident in its ability to compete effectively [60][61] - The company is focused on differentiating its products, particularly with the upcoming SIGI pump [62][63] Pharmacy Channel Opportunity - The pharmacy channel is seen as a significant growth opportunity, with about 30% of lives in the U.S. covered under pharmacy agreements [34][40] - Tandem is testing the waters in the pharmacy space, with the potential for it to become a material part of the business before the SIGI launch [32][34] Investor Sentiment - There is a growing appreciation among investors for Tandem's pharmacy opportunity, which is expected to enhance revenue and profitability [74][75] Additional Important Insights - The company is focused on innovation as a driver for market adoption, with expectations for increased penetration rates in both Type 1 and Type 2 diabetes populations [42][44] - Tandem's strategy includes offering a diverse portfolio of products to meet varying customer needs, which is expected to enhance its competitive position [65][66]

Company Overview - Tandem Diabetes Care, Inc. (TNDM) has seen its shares increase by approximately 6.5% over the past month, outperforming the S&P 500 [1] - The most recent earnings report is crucial for understanding the key drivers affecting the stock [1] Earnings Estimates - Estimates for Tandem Diabetes Care have trended downward over the past month, with the consensus estimate shifting by -19.45% [2] - The stock currently holds a Zacks Rank of 3 (Hold), indicating expectations for an in-line return in the coming months [4] VGM Scores - Tandem Diabetes Care has an average Growth Score of C, a Momentum Score of F, and a Value Score of C, placing it in the middle 20% for the value investment strategy [3] - The overall aggregate VGM Score for the stock is D, which is significant for investors not focused on a single strategy [3] Industry Performance - Tandem Diabetes Care is part of the Zacks Medical - Instruments industry, where another player, Intuitive Surgical, Inc. (ISRG), has gained 7.5% in the past month [5] - Intuitive Surgical reported revenues of $2.25 billion for the last quarter, reflecting a year-over-year increase of +19.2% [5] - The expected earnings for Intuitive Surgical in the current quarter are $1.92 per share, indicating a +7.9% change from the previous year [6]

Core Insights - Tandem Diabetes Care, Inc. is focused on innovative solutions for diabetes management and is expanding its international presence, which is expected to drive growth despite macroeconomic challenges and competitive pressures [1][2][10]. Group 1: Company Performance - Tandem Diabetes has experienced a significant stock decline of 56.4% over the past year, compared to a 12.1% decline in the industry, while the S&P 500 has risen by 12.5% during the same period [2]. - The company has a market capitalization of $1.57 billion and projects an earnings growth rate of 44.5% for 2026, surpassing the industry's growth rate of 20.8% [2]. - In the last four quarters, Tandem Diabetes has exceeded earnings estimates twice and missed them twice [2]. Group 2: Product Innovation - The t:slim X2 insulin pump software, launched in 2023, is now compatible with Dexcom G7 and G6 Continuous Glucose Monitoring systems, and has received approval for sale in Canada [4]. - The t:slim X2 is the first pump in the U.S. integrated with Abbott's FreeStyle Libre 2 Plus sensor, enhancing its competitive edge [4]. - The new Tandem Mobi device is under development, featuring a tubeless patch option for insulin delivery, which aims to expand wearability options [5]. Group 3: International Expansion - Sales outside the U.S. increased by 35.4% year-over-year in Q1 2025, with approximately 11,000 pumps shipped to 25 international markets [6]. - The company is enhancing its international strategy by appointing new leadership with global diabetes experience and aligning its technology offerings with its U.S. portfolio [6]. Group 4: Market Trends - The diabetes market is expected to grow due to an aging population, unhealthy lifestyles, and increased healthcare spending, with over 5 million people living with type 1 diabetes in the U.S. [7]. - The company aims to expand the adoption of insulin pumps among type 1 and type 2 diabetes patients, with recent FDA clearance for its Control IQ+ technology for type 2 diabetes patients [9]. Group 5: Challenges - Ongoing macroeconomic uncertainties may hinder the company's ability to predict product demand, potentially increasing operational costs [10]. - The competitive landscape includes numerous players, making it challenging for Tandem Diabetes to implement pricing strategies and maintain market share [11]. Group 6: Financial Projections - The Zacks Consensus Estimate for Tandem Diabetes' 2025 loss per share is projected at $1.37, reflecting a year-over-year improvement of 28.3% [12]. - The estimated revenue for 2025 is $1.01 billion, indicating a 10.5% increase from the previous year [12].

Tandem Diabetes Conference Call Summary Company Overview - **Company**: Tandem Diabetes - **Event**: RBC's 2025 Global Healthcare Conference - **Key Speakers**: Lee Wassler (CFO), Susan Morrison (Chief Administrative Officer) Key Points Industry and Market Dynamics - **Strong Q1 Performance**: Tandem Diabetes reported a strong first quarter with a 6.5% upside surprise and 22% year-over-year growth, shipping 28,000 new pumps [4][1] - **Market Expansion**: The company is focused on doubling its market size in the U.S. with type two diabetes indications and exploring direct sales outside the U.S. in future years [3][2] - **Under-Penetrated Market**: Approximately 1 million people in the U.S. live with type one diabetes, with only 40% using pumps, indicating significant growth potential [8][2] Product Performance - **Pump Shipments**: The breakdown of pump shipments is expected to be roughly 50% new starts and 50% renewals, with a notable shift towards MDI (Multiple Daily Injections) conversions driving growth [5][6] - **MDI Conversion Growth**: Mobi product has been a key driver for MDI conversions, contributing to double-digit growth for four consecutive quarters [7][8] - **Retention and Utilization**: Strong customer retention trends were noted, with close to 500,000 users worldwide and improved customer utilization in Q1 [14][15] Type Two Diabetes Opportunity - **Market Size**: There are approximately 2.3 million insulin-dependent type two diabetes patients in the U.S., with only 5% currently using pumps, presenting a substantial growth opportunity [20][21] - **Cautious Rollout**: The company is taking a measured approach to marketing and training for the type two market, focusing on understanding the population's needs [21][22] - **Synergistic Therapies**: The combination of GLP-1 medications and Control IQ technology has shown to improve patient outcomes, indicating a synergistic relationship [26][27] Financial Guidance and Projections - **2025 Guidance**: The company has included a modest benefit from type two opportunities and pharmacy expansion in its 2025 guidance, with expectations for significant growth in the back half of the year [25][48] - **Gross Margin Targets**: Tandem Diabetes aims for 60% gross margins by 2026, driven by Mobi and pharmacy channel expansion [38][39] - **Operating Margins**: The company is targeting 25% operating margins at 1 million customers, with potential to achieve this sooner than previously anticipated [53][54] Pipeline and Future Initiatives - **Product Development**: Tandem is advancing multiple projects, including t:slim x MobiPatch and SIGI, leveraging R&D expertise from previous product developments [56][59] - **Integration with CGM**: The integration with DexCom and Abbott's CGM technologies is expected to drive incremental adoption of pump therapy [40][41] Investor Insights - **Opportunities for Growth**: The company highlighted multiple growth opportunities, including type two market penetration and pharmacy channel expansion, which are not fully factored into current market valuations [60][61] - **Market Positioning**: Tandem Diabetes believes it has more opportunities than many competitors in the diabetes space, positioning itself for significant upside potential [61][62]