Sales Performance - Worldwide sales increased to $234.4 million, representing a 22% growth compared to $191.7 million in the first quarter of 2024[4] - Sales outside the United States reached $83.8 million, up from $61.9 million, marking a 35% increase year-over-year[22] - The company achieved record first quarter sales with a 22% worldwide growth and a 5-point adjusted EBITDA margin increase[5] - GAAP sales for Q1 2025 were $234,422,000, an increase of 22.3% compared to $191,674,000 in Q1 2024[24] - The company estimates full-year sales to be approximately $997 million to $1.007 billion, with U.S. sales projected at $725 million to $730 million[12] Profitability and Loss - GAAP gross profit was $118.4 million with a gross margin of 51%, compared to $94.7 million and 49% in the prior year[4] - GAAP operating loss was $120.9 million, or negative 52% of sales, compared to a loss of $41.7 million, or negative 22% of sales in Q1 2024[4] - Net loss for the quarter was $130.6 million, compared to a net loss of $42.7 million in the same period last year[7] - Adjusted EBITDA was negative $4.7 million, or negative 2% of sales, an improvement from negative $14.4 million, or negative 7% of sales in Q1 2024[7] - Non-GAAP gross profit for Q1 2025 was $118,407,000, up from $95,818,000 in Q1 2024, reflecting a non-GAAP gross margin of 51%[24] - GAAP operating loss for Q1 2025 was $(120,878,000), significantly higher than $(41,678,000) in Q1 2024, with a GAAP operating margin of (52)%[24] - Adjusted EBITDA for Q1 2025 was $(4,694,000), improving from $(14,450,000) in Q1 2024, resulting in an adjusted EBITDA margin of (2)%[24] - GAAP net loss for Q1 2025 was $(130,556,000), compared to $(42,715,000) in Q1 2024[24] - Non-GAAP net loss for Q1 2025 was $(44,172,000), slightly higher than $(41,569,000) in Q1 2024[24] Expenses and Charges - The company recorded $75,217,000 in acquired in-process research and development expenses in Q1 2025[25] - Impairment charges of $6.7 million were recorded for operating lease right-of-use assets in the U.S. and Switzerland[25] - Restructuring costs of $4.3 million were associated with the relocation of certain research and development activities[26] Other Information - Approximately 30% of U.S. lives are now covered through pharmacy benefits for Tandem Mobi[5] - Gross margin for the full year is estimated to be approximately 54% of sales[12] - The Tandem Choice program concluded in 2024, with no impact on sales for this program in 2025[24]

Company Overview - Tandem Diabetes Care, Inc. (TNDM) shares increased by 7.6% to close at $17.61, supported by high trading volume, contrasting with an 8.5% decline over the past four weeks [1] - The company is set to release its first quarter 2025 financial results on April 30, which has generated investor optimism [2] Financial Performance - In the fourth quarter, Tandem Diabetes reported a 44% increase in sales and over 25% growth in worldwide pump shipments [2] - The upcoming quarterly loss is expected to be $0.60 per share, reflecting a year-over-year change of +4.8%, with revenues projected at $220.24 million, up 14.9% from the previous year [3] Earnings Estimates - The consensus EPS estimate for the upcoming quarter has remained unchanged over the last 30 days, indicating a lack of recent earnings estimate revisions [4] - Trends in earnings estimate revisions are strongly correlated with near-term stock price movements, suggesting that monitoring TNDM's performance is crucial [4] Industry Context - Tandem Diabetes Care operates within the Zacks Medical - Instruments industry, where another company, Penumbra (PEN), also experienced a 7.7% increase in stock price [4] - Penumbra's consensus EPS estimate has changed by -2% over the past month, with a year-over-year change of +61% [5]

Company Overview - Tandem Diabetes Care, Inc. (TNDM) has launched Control-IQ+ technology, an advanced hybrid closed-loop algorithm for diabetes management, compatible with t:slim X2 insulin pump and Tandem Mobi System, targeting individuals with type 1 diabetes aged 2 and older, as well as adults with type 2 diabetes [1][3] Product Features - Control-IQ+ builds on the existing Control-IQ algorithm, allowing users to program extended boluses for up to 8 hours to manage delayed glucose rises [5] - New features include expanded weight parameters (20-440 lbs) and total daily insulin (5-200 units) to accommodate diverse insulin needs, along with Temp Basal Rate adjustments for short-term glucose management [6] Market Performance - Following the announcement of Control-IQ+, TNDM shares increased by 1.1% in after-market trading [2] - TNDM currently has a market capitalization of $1.33 billion and is projected to have an earnings per share (EPS) growth rate of 38.7% in 2025, significantly higher than the industry average of 15.6% [4] Industry Insights - The global insulin delivery device market was valued at $16.43 billion in 2023, with an expected compound annual growth rate of 7.9% by 2027, driven by the rising prevalence of diabetes and demand for advanced solutions [8][9] Strategic Developments - Tandem Diabetes has signed a multi-year collaboration with the University of Virginia Center for Diabetes Technology to advance research on fully automated closed-loop insulin delivery systems [11] - The t:slim X2 insulin pump became fully compatible with Dexcom G7 and G6 Continuous Glucose Monitoring Systems in December 2024 [11] Stock Performance - Over the past year, TNDM shares have declined by 38.2%, contrasting with the industry decline of 7.5% [12]

Core Viewpoint - Tandem Diabetes Care, Inc. (TNDM) has shown strong performance in Q4 2024, driven by innovative product offerings, but faces challenges from competition and macroeconomic factors [1][8]. Company Performance - TNDM's shares have decreased by 38.5% over the past year, contrasting with an 8.2% decline in the industry and a 10.6% rise in the S&P 500 [1]. - The company has a market capitalization of $1.21 billion and projects a 38.7% growth rate for 2025 earnings, compared to 29.5% for the S&P 500 [2]. Key Tailwinds - Product Innovation: TNDM's t:slim X2 insulin pump software is now compatible with Dexcom G7 and G6 CGM systems, enhancing its product offerings [3]. - New Product Launch: The Tandem Mobi, a new insulin therapy device, launched in the U.S. in February 2024, has received positive feedback from early users [4]. - Strategic Collaborations: TNDM signed a multi-year collaboration with the University of Virginia Center for Diabetes Technology to advance automated insulin delivery systems [6]. Strategic Developments - The company is focusing on operational cost savings through lean activities and manufacturing efficiencies [7]. - TNDM is also developing its Steadi-Set infusion technology, currently under FDA review, and accelerating the development of its Sigi patch pumps [5]. Key Headwinds - Macroeconomic Challenges: The company faces uncertainties due to global economic conditions, which could negatively impact profitability. In Q4, the cost of sales rose by 21% year-over-year [8]. - Competitive Pressure: TNDM operates in a highly competitive market with significant pressure from both large corporations and startups, limiting pricing strategy flexibility [9][10]. Estimate Trend - The Zacks Consensus Estimate for TNDM's 2024 loss per share has decreased by 2.5% to $1.17 in the last 30 days. The 2025 revenue estimate is projected at $1.00 billion, indicating a 10.1% increase from the previous year [11].

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Tandem Diabetes Care, Inc. (TNDM) posted a fourth-quarter 2024 loss of 44 cents per share compared with the year-ago quarter’s reported loss of 27 cents. The figure missed the Zacks Consensus Estimate of a loss of 25 cents per share.Find the latest EPS estimates and surprises on Zacks Earnings Calendar.On a GAAP basis, the company reported earnings of 1 cent per share compared to the year-ago loss of 46 cents.Full-year 2024 loss was $1.91 per share compared with the year-ago reported loss of $1.57. The figu ...

Financial Data and Key Metrics Changes - Annual worldwide sales reached a record $910 million, marking an 18% year-over-year increase [42] - Fourth quarter sales were $252 million, the largest in company history, with over 20% growth compared to the previous year [42] - Gross margin for 2024 was 51%, consistent with 2023, while adjusted EBITDA margin was negative 1% of sales [51][53] Business Line Data and Key Metrics Changes - In the U.S., pump shipments exceeded 24,000 in Q4, generating $184 million in sales, representing a 13% year-over-year growth [43] - Full year U.S. sales totaled $642 million, with nearly 81,000 pump shipments, a 10% increase [44] - Internationally, approximately 40,000 pumps were shipped for the full year, resulting in $268 million in sales, a 39% increase year-over-year [49] Market Data and Key Metrics Changes - The U.S. market saw strong performance from both t:slim and Mobi pump platforms, with significant growth in customers transitioning from multiple daily injections [19] - Outside the U.S., strong double-digit growth was driven by demand for the t:slim pump platform [19] - The company is transitioning to direct commercial operations in select European countries, expected to begin in 2026 [39] Company Strategy and Development Direction - The introduction of the Tandem Mobi pump platform is a key strategic focus, aimed at expanding the customer base and enhancing market presence [9][24] - The company is investing in a multichannel payer strategy to improve access and affordability for its products [16] - Plans for 2025 include launching new technology solutions and expanding the product portfolio, including the Sigi patch pump [63][67] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the underlying trends of the business despite challenges in Q4, including shipping delays and muted seasonality [20][78] - The company anticipates continued growth driven by renewals and new starts from MDI conversions, with expectations for a strong performance in 2025 [55] - The FDA's recent approval for Control-IQ+ for type 2 diabetes significantly expands the addressable market, positioning the company for long-term growth [15][117] Other Important Information - The company ended 2024 with $438 million in total cash and investments, indicating a strong financial position to support future commitments [53] - The Tandem Choice program concluded in Q4, allowing eligible customers to switch to Mobi, which will impact future sales recognition [48] Q&A Session All Questions and Answers Question: Can you quantify the Q4 shipping delays and December trends? - Management noted that the majority of the shortfall in Q4 was due to a muted seasonal curve in December, with shipping delays being a contributing factor but not the primary issue [76][78] Question: What are the next steps for the Pharmacy initiative? - The company is focused on driving scale and efficiency in the Pharmacy channel, having signed multiple contracts with leading PBMs, translating to approximately 20% of covered lives [84] Question: Will there be meaningful margin improvement from Mobi conversions this year? - Management confirmed that while Mobi's manufacturing costs are expected to improve, significant margin benefits from cartridges will begin in 2026 [88] Question: What new product innovations are included in the guidance for this year? - The guidance includes enhancements from Control-IQ+, integration with FreeStyle Libre 3, and the introduction of the Android app for Mobi [90][93] Question: How is the U.S. sales force expansion progressing? - The sales force expansion is nearly complete, with a focus on optimizing efficiencies and increasing share of voice in high-potential accounts [110][112] Question: What is the expected contribution from type 2 diabetes to new starts? - Management anticipates that type 2 diabetes could increase the percentage of new starts significantly, with a pilot launch planned for March [119][120]

Financial Performance - For the quarter ended December 2024, Tandem Diabetes Care, Inc. reported revenue of $252.45 million, reflecting a 28.3% increase year-over-year [1] - The earnings per share (EPS) was reported at -$0.44, compared to -$0.27 in the same quarter last year, indicating a decline [1] - The reported revenue was slightly below the Zacks Consensus Estimate of $255.18 million, resulting in a revenue surprise of -1.07% [1] - The company experienced an EPS surprise of -76.00%, with the consensus EPS estimate being -$0.25 [1] Key Metrics - Shares of Tandem Diabetes Care have returned -8.4% over the past month, while the Zacks S&P 500 composite changed by -2.3% [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3] Geographic Sales - United States sales reached $214.56 million, exceeding the average estimate of $190.90 million by three analysts, representing a year-over-year increase of 42.2% [4] - Sales outside the United States were reported at $68.09 million, significantly surpassing the average estimate of $59.87 million, with a year-over-year change of 148291.5% [4] - Pump sales in the United States totaled $98.44 million, slightly below the average estimate of $101.47 million, marking a 19.5% year-over-year increase [4] - Supplies and other sales in the United States were $85.92 million, compared to the average estimate of $89.43 million, reflecting a 6% year-over-year change [4] - Pump sales outside the United States were $25.77 million, exceeding the average estimate of $19.85 million, with a year-over-year increase of 47.2% [4] - Supplies and other sales outside the United States reached $42.32 million, surpassing the average estimate of $40.50 million, indicating a 14.9% year-over-year change [4] - Total revenue from supplies and other was $128.24 million, slightly below the average estimate of $128.87 million [4] - Revenue from pumps was reported at $124.21 million, exceeding the average estimate of $121.53 million [4]

Tandem Diabetes Care, Inc. (TNDM) came out with a quarterly loss of $0.44 per share versus the Zacks Consensus Estimate of a loss of $0.25. This compares to loss of $0.27 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -76%. A quarter ago, it was expected that this company would post a loss of $0.43 per share when it actually produced a loss of $0.36, delivering a surprise of 16.28%.Over the last four quarters, the company has ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _________________________________________________________________ FORM 10-K _________________________________________________________________ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-36189 ______ ...