Tandem Diabetes Care, Inc. (TNDM) is driving transformative innovation to help reduce the burden and create new possibilities for people living with diabetes. Its strong focus on overseas expansion is another positive. Additionally, favorable trends in the diabetes market position the company well for growth in the upcoming quarters. However, the ongoing macroeconomic volatilities and tough competitive space pose risks for Tandem Diabetes’ operations.In the past year, this Zacks Rank #3 (Hold) stock fell 56 ...

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]

Tandem Diabetes Care, Inc. (NASDAQ:TNDM) Q1 2025 Earnings Conference Call April 30, 2025 4:30 PM ET Company Participants Susan Morrison - EVP & Chief Administrative Officer John Sheridan - President & CEO Leigh Vosseller - EVP & CFO Conference Call Participants Matt Miksic - Barclays Mat Blackman - Stifel Steve Lichtman - Oppenheimer & Company Matthew O'Brien - Piper Sandler David Roman - Goldman Sachs Matthew Taylor - Jeffries Chris Pasquale - Nephron Research Anthony Petrone - Mizuho Financial Groups Josh ...

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]

Tandem Diabetes Care (TNDM) Q1 2025 Earnings Call April 30, 2025 04:30 PM ET Company Participants Susan Morrison - EVP & Chief Administrative OfficerJohn Sheridan - President and CEOLeigh Vosseller - EVP, CFO & TreasurerMathew Blackman - Managing DirectorAaron Wukmir - Healthcare Equity Research AssociateDavid Roman - Managing DirectorMatthew Taylor - Managing DirectorChris Pasquale - Partner - Medical Devices & SuppliesAnthony Petrone - Managing Director Equity ResearchJoshua Jennings - Managing DirectorIs ...

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].