Tandem Diabetes Care (TNDM) FY Conference Summary Company Overview - Tandem Diabetes Care operates in a large and underpenetrated market focused on diabetes management, particularly for type one and type two diabetes [1] Market Opportunity - In the US, approximately 2 million people have type one diabetes, with only 40% using pump therapy, indicating a significant opportunity to reach the remaining 60% [2] - The type two diabetes market in the US has about 2 million individuals, with only 5% currently using pumps, further expanding the potential customer base [3] Product Portfolio and Strategy - Tandem has historically focused on product offerings emphasizing ease of use, simplicity, and flexibility, with a portfolio that includes the t slim x2 and Tandem Mobi [4] - The company is expanding its business model to include pharmacy benefits, which could reduce out-of-pocket costs for patients and increase adoption of pump therapy [5][6] - Plans to transition to a direct sales model in key international markets starting in 2026 to optimize revenue growth and margins [6] Financial Guidance and Market Dynamics - The company adjusted its fiscal year 2025 guidance to $1 billion for the US and $700 million for international markets, reflecting a cautious outlook due to competitive pressures and internal transformations [8][11] - The US market is undergoing a commercial transformation, including Salesforce expansion and new tools to enhance operational efficiency [14][15] - A new competitor entering the market is expected to create short-term turbulence, although no immediate evidence of market pausing has been observed [16][18] Pharmacy Channel Entry - Tandem has begun entering the pharmacy channel with Mobi, which is expected to reduce barriers for patients and enhance sales in the fourth quarter [20] - Currently, the company has contracts covering 30% of lives in the US, with plans to increase this coverage [22][24] Type Two Diabetes Initiative - The company is in a pilot launch phase for type two diabetes, focusing on ease of onboarding and positive clinical outcomes [30][32] - Feedback from healthcare providers has been encouraging, and efforts will expand in the second half of the year [32] Regulatory Environment and Cash Flow - Proposed changes from CMS regarding insulin pumps and a pay-as-you-go model are being monitored, but the impact on Tandem is expected to be minimal [35][36] - The company anticipates becoming free cash flow positive in the latter half of the year, with a focus on improving gross margins and managing operating expenses [45][47] Product Development and Future Innovations - Tandem has received FDA clearance for an extended wear infusion set, which will enhance the usability of its products [54] - The company is actively pursuing a fully closed-loop trial and has completed a feasibility study, with further updates expected [61][62] Conclusion - Tandem Diabetes Care is positioned for growth with a robust product pipeline and strategic market expansions, despite facing competitive challenges and regulatory uncertainties. The focus on pharmacy integration and type two diabetes initiatives is expected to drive future revenue and improve cash flow sustainability [33][38]

Financial Data and Key Metrics Changes - The company achieved record second quarter sales of $241 million, representing a 15% year-to-date growth with $475 million in worldwide sales [19][20] - Gross margin for the second quarter was 52%, reflecting an increase year-over-year and compared to the first quarter, driven by pricing improvements [26][32] - The company expects to achieve $1 billion in worldwide sales for 2025, with a geographic mix of approximately $700 million in the U.S. and $300 million outside the U.S. [30][31] Business Line Data and Key Metrics Changes - In the U.S., pump shipments saw a year-over-year increase, with renewals making up over half of the shipments, indicating strong retention [6][7] - The Tandem Mobi platform received positive feedback and contributed to new user demand, with year-over-year increases in adoption [9] - The flagship t:slim X2 pump continues to receive high customer satisfaction scores, with new integrations announced [10] Market Data and Key Metrics Changes - International markets delivered strong performance, driven by demand for t:slim and increasing pump renewals [13][25] - The company is preparing for the launch of Tandem OBI in international markets after receiving CE Mark [14] - The company anticipates a reduced headwind of approximately $10 million from transitioning to direct sales in international markets [30][52] Company Strategy and Development Direction - The company is focused on expanding its multi-channel market access strategy, including pharmacy channel initiatives to lower out-of-pocket costs for patients [5][21] - There is a strategic push to bring Tandem's technology to type two diabetes patients, with pilot activities showing promising adoption rates [11][12] - The company aims to modernize its business systems and expand its sales force to improve efficiency and effectiveness [62] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving double-digit growth and highlighted the importance of ongoing commercial transformation efforts [30][62] - The competitive environment remains intense, with new market entrants causing some caution in the second half of the year [66][112] - Management noted that traditional Medicare represents a small portion of sales, and changes in reimbursement structures could ultimately benefit the business [41][24] Other Important Information - The company ended the quarter with $315 million in total cash and investments, with notable cash uses including settling convertible notes and a settlement agreement [29] - The company is committed to innovation, with ongoing R&D efforts and a focus on enhancing its product portfolio [35][37] Q&A Session Summary Question: Impact of CMS proposal on business - Management does not anticipate a material impact from the CMS proposal, viewing it as a potential driver for more people to adopt pump therapy [41][42] Question: Progress on pharmacy channel - The pharmacy channel is expected to bring more volume and revenue, with plans to move t:slim supplies into this channel starting in Q4 [45][47] Question: Changes in international outlook - The international business has performed well, with a reduced headwind expected from transitioning to direct sales [52] Question: U.S. renewal rates and new patient numbers - Renewals grew double digits and represent over half of shipments, with a focus on MDI conversions for new starts [57][58] Question: Lowered U.S. guidance - The lowered guidance reflects ongoing commercial transformation efforts and increased competition from new entrants [62][112]

Core Insights - Abbott Laboratories' Diabetes Care business is experiencing significant growth, primarily driven by the FreeStyle Libre continuous glucose monitoring (CGM) platform, which has achieved global leadership in the CGM market for both Type 1 and Type 2 diabetes users [1][2]. Company Developments - Abbott has received FDA approvals for two new over-the-counter CGM systems, Lingo and Libre Rio, expanding its consumer reach and marking a new era in the U.S. market [2][8]. - In Q2 2025, Abbott's CGM sales exceeded $1.90 billion, reflecting a 19.6% organic growth, with U.S. Libre sales increasing nearly 26% [4][8]. - The upcoming launch of Abbott's dual-analyte sensor, which includes ketone monitoring, is expected to enhance its market share, particularly among intensive insulin users [4][8]. Market Trends - The diabetes care devices market is projected to grow significantly, reaching $99.81 billion by 2035, with a compound annual growth rate (CAGR) of 9.6% from 2025 to 2035 [3]. - The increasing aging population, rising obesity rates, and sedentary lifestyles are driving demand in this fast-growing market [3]. Competitive Landscape - Competitors like DexCom and Tandem Diabetes are also expanding their offerings in the CGM space, with DexCom focusing on its G6 and G7 systems and Tandem enhancing its pump portfolio and digital solutions [5][6]. Financial Performance - Year-to-date, Abbott's shares have increased by 19.7%, outperforming the industry growth of 7.9% and the S&P 500's growth of 21.5% [7]. - Abbott currently trades at a forward 12-month Price-to-Sales (P/S) ratio of 4.84X, below the industry average of 5.63X [10].

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].