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]

Core Insights - Tandem Diabetes Care, Inc. reported a first-quarter 2025 loss of 67 cents per share, which was worse than the previous year's loss of 63 cents and missed the Zacks Consensus Estimate of a loss of 60 cents per share [1] - Despite the earnings miss, TNDM's stock surged 18.6% following the announcement [1] - The company achieved record quarterly revenues, with non-GAAP revenues of $234.4 million, reflecting a year-over-year increase of 21.6% and surpassing the Zacks Consensus Estimate by 6.4% [2] Revenue Performance - Non-GAAP revenues for the first quarter were $234.4 million, up 21.6% year over year, and GAAP revenues also totaled $234.4 million, marking a 22.2% increase [2] - In the United States, non-GAAP sales reached $150.6 million, a 15% increase year over year, with over 17,000 pumps shipped [4] - Internationally, non-GAAP sales were $83.8 million, up from $61.9 million in the prior-year period [5] Margins and Expenses - Gross profit for the quarter was $118.4 million, a 25.1% increase year over year, with a gross margin of 50.5%, up 112 basis points despite a 19.6% rise in the cost of sales [6] - Selling, General and Administrative (SG&A) expenses rose 26.3% to $113.8 million, while Research and Development (R&D) expenses increased 8.6% to $50.2 million [6] - The adjusted operating loss was $45.7 million, compared to a loss of $41.7 million in the same period last year [6] Financial Position - At the end of the first quarter of 2025, Tandem Diabetes had cash, cash equivalents, and short-term investments totaling $368.6 million, down from $438.3 million at the end of the fourth quarter of 2024 [7] Guidance - The company reaffirmed its full-year 2025 GAAP financial guidance, estimating sales between $970 million and $1.007 billion, with the Zacks Consensus Estimate for full-year revenues at $1.00 billion [8] - GAAP sales in the United States are projected to be between $725 million and $730 million, while sales outside the United States are expected to be in the range of $272 million to $277 million [10] Overall Assessment - Tandem Diabetes ended the first quarter of 2025 with mixed results, as earnings lagged estimates but revenues exceeded expectations, driven by an expanding product portfolio [11] - The launch of Control-IQ+ technology for type 2 diabetes patients in the U.S. contributed to the strong performance [11] - However, the company's operating loss remains a concern [12]

Group 1 - Tandem Diabetes Care, Inc. held its Q1 2025 Earnings Conference Call on April 30, 2025, at 4:30 PM ET [1] - The call featured key company participants including Susan Morrison, John Sheridan, and Leigh Vosseller [1][2] - The conference included a presentation followed by a question and answer session for participants [2] Group 2 - The discussion included forward-looking statements regarding management's expectations about future events, product pipeline, development timelines, and financial performance [4] - Management emphasized that these statements reflect expectations as of the date of the call [4]

Core Insights - Tandem Diabetes Care, Inc. reported $234.42 million in revenue for Q1 2025, a year-over-year increase of 22.3% [1] - The EPS for the same period was -$0.67, compared to -$0.63 a year ago, indicating a decline [1] - The revenue exceeded the Zacks Consensus Estimate of $220.24 million by 6.44%, while the EPS fell short of the consensus estimate of -$0.60 by 11.67% [1] Financial Performance Metrics - The company’s stock has returned -10.5% over the past month, underperforming the Zacks S&P 500 composite, which changed by -0.2% [3] - Tandem Diabetes Care has a Zacks Rank 4 (Sell), suggesting potential underperformance in the near term [3] Pump Shipments and Sales - U.S. pump shipments totaled 17,000, slightly above the average estimate of 16,952 [4] - Total worldwide pump shipments were 28,000, below the average estimate of 29,200 [4] - Outside the U.S., pump shipments were 11,000, compared to the average estimate of 12,248 [4] Geographic Sales Performance - Geographic sales outside the U.S. reached $83.79 million, exceeding the average estimate of $74.74 million, representing a year-over-year change of +35.4% [4] - U.S. pump sales were $72.14 million, slightly above the average estimate of $71.94 million, with a year-over-year increase of +16.9% [4] - Sales of supplies and other products in the U.S. amounted to $78.49 million, surpassing the average estimate of $74.32 million, reflecting a year-over-year change of +13.5% [4] - Outside the U.S., pump sales were $29.95 million, below the average estimate of $31.46 million, with a year-over-year change of +17.1% [4] - Sales of supplies and other products outside the U.S. reached $53.84 million, exceeding the average estimate of $43.03 million, representing a year-over-year change of +48.1% [4] - Total geographic revenues in the U.S. were $150.63 million, above the average estimate of $146.17 million, with a year-over-year change of +16.1% [4] - Non-GAAP geographic revenues in the U.S. were $150.63 million, compared to the average estimate of $146.45 million [4] - Revenue from supplies and other products was $132.33 million, exceeding the average estimate of $118.22 million [4] - Pump revenue was $102.09 million, slightly below the average estimate of $102.82 million [4]

Company Performance - Tandem Diabetes Care, Inc. reported a quarterly loss of $0.67 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.60, and compared to a loss of $0.63 per share a year ago, indicating an earnings surprise of -11.67% [1] - The company posted revenues of $234.42 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 6.44%, and showing an increase from year-ago revenues of $191.67 million [2] - Over the last four quarters, Tandem Diabetes Care has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Performance - Tandem Diabetes Care shares have declined approximately 53.4% since the beginning of the year, in contrast to the S&P 500's decline of -5.5% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.34 on revenues of $247.82 million, and for the current fiscal year, it is -$1.17 on revenues of $1 billion [7] Industry Outlook - The Medical - Instruments industry, to which Tandem Diabetes Care belongs, is currently ranked in the top 25% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8] - The performance of Tandem Diabetes Care's stock may be influenced by the overall outlook for the industry [8]

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 - Tandem Diabetes Care has approximately 480,000 in-warranty customers across 25 countries[5, 81] - The company is headquartered in San Diego with around 2,600 employees worldwide[5, 81] - Tandem offers two pump platforms: t:slim X2 and Tandem Mobi, both featuring Control-IQ+ Technology and cleared for type 1 and type 2 diabetes[8, 84] Product Portfolio - The Tandem Mobi system is 55% smaller than other insulin pumps[17] - 95% satisfaction rate among Tandem Mobi Early Access Participants[16] - The t:slim X2 insulin pump is the first in the US to integrate with three continuous glucose monitoring sensors[22] Market and Growth - Less than 40% of the approximately 2 million people with type 1 diabetes in the U S use an insulin pump[55] - Less than 20% of the approximately 3 million people with type 1 diabetes in the countries Tandem serves use a pump[55] - Approximately 5% of the over 2 million people with type 2 Insulin Intensive Diabetes in the U S use an insulin pump[55] Financials - Pumps are reimbursed at approximately $4,000 domestically and $3,000 OUS every 4 years[78] - Supplies cost approximately $4,000 per patient per year, with 120 cartridges and infusion sets used[78] - The total amount realized per patient is approximately $7,000-$8,000 in a four-year reimbursement cycle[79]

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]