Financial Data and Key Metrics Changes - The company achieved record first quarter sales of $234 million, representing a 22% year-over-year growth [19] - Adjusted EBITDA improved by five percentage points year-over-year, indicating enhanced profitability [19][24] - Gross margin for Q1 was 51%, consistent with historical trends, driven by reduced per unit costs [24][29] Business Line Data and Key Metrics Changes - In the U.S., sales reached $151 million, a 15% increase year-over-year, driven by healthy pump shipments and strong supply sales [20] - Internationally, sales were $84 million, reflecting a 35% year-over-year growth, supported by demand for the t:slim X2 platform [23] - The product mix between the t:slim X2 and the new Tandem Movi is healthy, with a significant portion of new starts coming from patients converting from multiple daily injections [10][11] Market Data and Key Metrics Changes - Approximately 30% of U.S. lives are now covered under the pharmacy benefit, up from 20% previously reported [21][68] - The company anticipates that more than 70% of sales for the year will come from predictable and recurring revenue streams from supplies and renewals [26] Company Strategy and Development Direction - The company plans to launch new sensor integrations and enhance its technology ecosystem, including the introduction of the Control IQ Plus algorithm [32][34] - Direct sales efforts in select international markets are progressing well, with plans to enhance sales support and technology offerings [17] - The company aims to achieve sustained double-digit sales growth and profitability through improved pricing and disciplined cost management [30][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 2025 commitments despite a dynamic economic environment [25][72] - The company is focused on expanding its pharmacy channel access and scaling growth into the type two diabetes market [37] - Management highlighted the importance of the Control IQ Plus launch and its potential to double the addressable market [15][78] Other Important Information - The company ended the quarter with nearly $370 million in total cash and investments, anticipating a return to positive free cash flow in the second half of 2025 [25] - The company is committed to bringing an industry-leading fully closed loop algorithm to market, with ongoing R&D efforts [36] Q&A Session Summary Question: Update on sales force changes and realignment - Management confirmed that the territory realignment is complete and expects gradual improvement in sales productivity over the next several quarters [40][41] Question: Impact of pricing on U.S. sales - Management indicated that pricing contributed approximately 2% to 3% for pumps and around 10% for supplies, suggesting this is a sustainable level moving forward [45][46] Question: Competitive dynamics in the U.S. market - Management noted that the U.S. market remains competitive but has not seen significant changes recently, with confidence in their product offerings [92][94] Question: Expectations for pharmacy channel contributions - Management stated that pharmacy contributions are expected to be modest in 2025, but early experiences indicate strong potential for future growth [53][68] Question: Guidance reaffirmation after strong Q1 - Management reaffirmed guidance due to the dynamic economic environment, despite a strong performance in Q1 [72] Question: Type two diabetes market potential - Management highlighted that the recent approval of Control IQ Plus has provided access to approximately 300,000 people, with modest contributions factored into 2025 guidance [77][78]

Company Overview APRIL 30, 2025 Ben diagnosed 2024 Izzy diagnosed 2014 Safe Harbor CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Certain statements in this presentation constitute forward-looking statements, including, without limitation, statements about: the perceived advantages of our products relative to competitive products and technologies; our anticipated growth and other measures of future operating results and financial performance; the development and commercialization of new products; our ...

Financial Data and Key Metrics Changes - The company achieved record first quarter sales of $234 million, representing a 22% year-over-year growth [17] - Adjusted EBITDA improved by five percentage points year-over-year, indicating a strong operational performance [22] - Gross margin for Q1 was 51%, consistent with Q4, driven by reduced per unit costs of pumps [22][28] Business Line Data and Key Metrics Changes - In the U.S., sales reached $151 million, a 15% increase year-over-year, driven by healthy pump shipments and strong supply sales [18] - Internationally, sales were $84 million, reflecting a 35% year-over-year growth, supported by demand for the t:slim X2 platform [21] - The product mix between the t:slim X2 and the new Tandem Movi is healthy, with a significant portion of new starts coming from patients converting from multiple daily injections [7][8] Market Data and Key Metrics Changes - Approximately 30% of U.S. lives are now covered under the pharmacy benefit, up from 20% previously, indicating improved market access [19][67] - The company anticipates that sales outside the U.S. will be relatively flat for the remainder of the year due to a timing shift in orders [27] Company Strategy and Development Direction - The company plans to enhance its sales efforts and technology offerings outside the U.S. as it prepares for direct sales in select countries starting in 2026 [15] - New product launches, including the Control IQ Plus algorithm and sensor integrations, are expected to drive growth in both U.S. and international markets [30][32] - The company is focused on improving profitability through increased pricing, margin improvement initiatives, and disciplined cost management [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 2025 commitments despite a dynamic economic environment [23][73] - The company is optimistic about the growth potential from the type two diabetes indication, which more than doubles the addressable market [13][79] - Management reaffirmed guidance for sales, gross margin, and EBITDA for 2025, indicating a strong outlook for the year [24][73] Other Important Information - The company has completed its sales force expansion and territory realignment, which is expected to enhance productivity over the coming quarters [9][39] - The recent FDA clearance of Control IQ Plus for type two diabetes is a significant milestone, with initial commercial efforts already underway [11][13] Q&A Session Summary Question: Update on sales force changes and realignment - Management confirmed that the territory realignment is complete and expects gradual improvement in productivity over the next several quarters [39] Question: Impact of pricing on U.S. sales - Management indicated that pricing contributed approximately 2% to 3% for pumps and around 10% for supplies, suggesting this is a sustainable level moving forward [44][45] Question: Competitive dynamics in international markets - Management noted that the competitive environment remains stable, with strong demand for their technology and products in international markets [88] Question: Expectations for pharmacy channel contributions - Management stated that pharmacy contributions are expected to be modest in 2025, but early experiences indicate significant long-term potential [52][68] Question: Clarification on SIGI development timeline - Management clarified that the termination of the previous agreement allows for more control over the development path, potentially improving time to market [58][59] Question: Gross margin performance and future expectations - Management highlighted that improvements in pump costs and the introduction of Mobi are key factors in achieving long-term gross margin targets [62][63] Question: Type two indication and market access - Management acknowledged that while there is coverage for type two patients, Medicare approval processes may present initial challenges [78][80]

Financial Performance - Total sales for the three months ended March 31, 2025, were $234,422,000, representing a 22.3% increase from $191,674,000 in the same period of 2024[10]. - Gross profit for Q1 2025 was $118,407,000, up from $94,672,000 in Q1 2024, indicating a gross margin improvement[10]. - Net loss for Q1 2025 was $130,556,000, compared to a net loss of $42,715,000 in Q1 2024, indicating a significant increase in losses year-over-year[10]. - For the three months ended March 31, 2025, the company reported a net loss of $130.6 million, compared to a net loss of $42.7 million for the same period in 2024, representing an increase in losses of approximately 206%[15]. - The total interest expense for the three months ended March 31, 2025, was $1.8 million, an increase from $1.6 million in the same period of 2024[81]. Operating Expenses - Operating loss increased to $120,878,000 in Q1 2025 compared to a loss of $41,678,000 in Q1 2024, reflecting higher operating expenses[10]. - Total operating expenses for Q1 2025 were $239.3 million, significantly higher than $136.4 million in Q1 2024, driven by $75.2 million in acquired in-process research and development expenses[10]. - The company reported stock-based compensation expense of $25.489 million for the three months ended March 31, 2025, up from $22.039 million in the same period of 2024, an increase of 11.1%[15]. Assets and Liabilities - Total current assets decreased to $663,435,000 as of March 31, 2025, down from $724,491,000 at the end of 2024[8]. - Total liabilities increased to $766,851,000 as of March 31, 2025, compared to $704,560,000 at the end of 2024[8]. - Stockholders' equity decreased to $155,292,000 as of March 31, 2025, down from $263,098,000 at the end of 2024, reflecting the impact of net losses[8]. - Total assets as of March 31, 2025, were $352.5 million, a decrease from $425.3 million as of December 31, 2024, representing a decline of approximately 17.1%[1]. Cash Flow - Net cash used in operating activities was $18.3 million for the three months ended March 31, 2025, compared to $8.0 million for the same period in 2024, indicating a 129% increase in cash outflow[15]. - Cash and cash equivalents at the end of the period were $53.6 million, down from $59.0 million at the end of the same period in 2024, reflecting a decrease of approximately 7.4%[15]. - The company reported a net cash provided by investing activities of $9.2 million for the first quarter of 2025, contrasting with a net cash used of $5.1 million in the same period of 2024[15]. Research and Development - Research and development expenses rose to $50,215,000 in Q1 2025 from $46,244,000 in Q1 2024, highlighting ongoing investment in innovation[10]. - The company incurred $75.2 million in acquired in-process research and development expenses during the first quarter of 2025, with no such expenses reported in the same period of 2024[15]. Revenue Sources - The company’s revenue is primarily generated from sales of insulin pumps and related products, with revenue recognition occurring upon transfer of control to customers[30]. - Revenue from the United States was $150.6 million, up from $129.8 million in the prior year, while revenue from outside the United States increased to $83.8 million from $61.9 million[100]. - Sales of insulin pumps reached $102.1 million, compared to $87.3 million in the previous year, while supplies and other sales totaled $132.3 million, up from $105.5 million[101]. Investments and Securities - The company held equity method investments valued at $71.0 million as of March 31, 2025, down from $74.5 million at the end of 2024[28]. - The company recognized a loss of $3.5 million from equity method investments for the three months ended March 31, 2025, with no such losses reported in the same period of 2024[29]. - The company’s short-term investments totaled $315.051 million as of March 31, 2025, compared to $369.095 million at December 31, 2024[44]. Warranty and Allowances - As of March 31, 2025, the total product warranty reserve increased to $52.210 million from $51.408 million at December 31, 2024[38]. - The allowance for credit losses decreased to $7.125 million as of March 31, 2025, from $7.251 million at December 31, 2024[49]. - Estimated warranty costs are recorded at shipment, with a four-year warranty on insulin pumps and a six-month warranty on cartridges and infusion sets[36]. Debt and Financing - The company issued $316.3 million in convertible senior notes due 2029 in March 2024, with net proceeds of $306.8 million after costs[67]. - The fair value of outstanding convertible senior notes decreased from $446.9 million on December 31, 2024, to $341.0 million on March 31, 2025, a reduction of about 23.7%[58]. - The initial conversion price for the 2029 notes is approximately $34.56 per share, with a conversion rate of 28.9361 shares per $1,000 principal amount[71]. Legal Matters - The Company is involved in ongoing legal disputes regarding patent infringement claims related to its t:slim X2 insulin pump, with hearings scheduled for June 2025[106][107].

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].

Group 1 - The marketplace channel Haggerston BioHealth offers exclusive stock tips focused on Pharma, Biotech, and Healthcare, providing access to investment bank-grade financial models and research [1] - The group caters to both novice and experienced biotech investors, offering insights on catalysts, buy and sell ratings, product sales forecasts, and integrated financial statements [2] - Edmund Ingham, a biotech consultant with over 5 years of experience, leads the Haggerston BioHealth investing group and has compiled detailed reports on over 1,000 companies [2]

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 ...