Financial Data and Key Metrics Changes - In Q3 2025, Tandem Diabetes Care achieved record sales of $249 million, with U.S. sales approximately $176 million, marking the highest third quarter to date and the second highest quarter ever [15][16] - Gross margin increased by 3 percentage points year over year, reaching 54% in Q3, with adjusted EBITDA returning to positive [15][17] - The company ended the quarter with $319 million in total cash and investments, indicating a strong financial position [19] Business Line Data and Key Metrics Changes - Pump shipments in the U.S. were over 20,000, slightly down from Q2 due to pharmacy stocking benefits recognized in the previous quarter [16] - International sales reached $74 million, also a record for Q3, primarily driven by favorable foreign currency exchange rates [17] - Renewals continue to track to a historical capture rate of over 70% of eligible customers within 18 months after warranty expiration [16] Market Data and Key Metrics Changes - The U.S. market saw a significant contribution from pricing, with a 5% increase in Q3, driven by both DME and pharmacy channels [16] - International sales are expected to grow approximately 12% year over year, despite headwinds from distributor inventory destocking [20] Company Strategy and Development Direction - The company is focused on three primary initiatives: modernization of commercial operations, driving innovation, and reshaping the business model [4][10] - Direct sales initiatives in Europe are set to begin in early 2026, with the aim of strengthening financial position and accelerating sales growth [6][20] - The launch of Mobi Tubeless is prioritized, expected to significantly enhance user preference and market presence [26][67] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving double-digit growth in 2025, with a target of $1 billion in worldwide sales [20][24] - The company anticipates a strong fourth quarter, with expectations for gross margins in the mid to high 50s [20][59] - Management highlighted the importance of pharmacy access and new product introductions in driving future growth [35][51] Other Important Information - The company has successfully increased pharmacy benefit coverage for Tandem Mobi to over 40% of U.S. lives [11] - A significant focus is placed on enhancing efficiencies and optimizing operations to strengthen operating margins [18][19] Q&A Session Summary Question: Can you provide insights on the cadence of growth for 2026? - Management indicated that multiple initiatives are expected to build momentum throughout 2026, with a focus on Mobi and pharmacy channel expansion [34][36] Question: What is the expected pricing uplift from supplies going through the pharmacy? - Management noted that pricing increases have been a significant contributor to revenue growth, with expectations for continued benefits as pharmacy access expands [39][41] Question: How do you expect Q4 to perform compared to last year? - Management confirmed that Q4 expectations are built on lessons learned from 2024, with a focus on new renewal opportunities [42][44] Question: What percentage of new patient starts were type 2 this quarter? - Management stated that renewals have been slightly more than half of shipments, with MDI conversions making up about two-thirds of new shipments [46][48] Question: Can you clarify the timeline for the Mobi Tubeless launch? - Management confirmed that Mobi Tubeless is expected to enter the market in 2026, pending 510(k) submission approval [90]

Financial Data and Key Metrics Changes - In Q1 2025, net revenue grew 24% to $6.3 million compared to $5 million in the prior year period [16] - U.S. revenue for Q1 was $4.5 million, while revenue outside the U.S. was $1.8 million [16] - Gross profit increased to $1.5 million from $300,000 in the prior year, driven by improved margins on the Eversense three sixty five product [19] - Net loss decreased to $14.3 million or $0.02 loss per share, compared to a net loss of $18.9 million or $0.03 loss per share in Q1 2024 [21] - Cash, restricted cash, and cash equivalents totaled $64.6 million as of March 31, 2025 [21] Business Line Data and Key Metrics Changes - The Eversense three sixty five product is expected to be the single product offering by the end of 2025, enhancing global supply chain synergies [11] - Approximately 13% of revenue flowed through the office consignment program, with over 100 healthcare providers participating [18] - The company is transitioning reimbursement from 180 days to 365 days for Eversense, with many payers already transitioning their coverage [12] Market Data and Key Metrics Changes - The company anticipates doubling the global patient base in 2025 compared to 2024, with revenue expected to be approximately one-third in the first half and two-thirds in the second half of the year [23] - The European launch of Eversense three sixty five is planned for the second half of 2025, pending regulatory approval [11][22] Company Strategy and Development Direction - The company is focused on transforming diabetes care through technological advancements, including collaborations with Sequel and Sweet Spot [6][7] - The integration of Eversense three sixty five with Sequel's Twist automated insulin delivery system is seen as a significant step forward [6] - Continued development of pipeline products, GEMINI and Freedom, is a priority, with plans to submit an IDE for a pivotal study by year-end [13][14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early launch metrics for Eversense three sixty five, indicating strong interest and conversion rates [32] - The company expects to mitigate any negative impacts from tariffs on gross profit margins through operational changes and industry exemptions [24] - Full-year gross margins are projected to be between 25% and 30%, with expectations for steady increases each quarter in 2025 [24] Other Important Information - The company received gross proceeds of approximately $27 million from the sale of common stock, extending its cash runway into mid-2026 [22] - All preferred stock was converted into common stock, impacting the diluted earnings per share calculation [21] Q&A Session Summary Question: Guidance despite Mercy contract pause - Management noted that early launch metrics for Eversense three sixty five are positive, and while the Mercy contract pause is a concern, the overall trajectory remains strong [30][32] Question: Direct-to-consumer (DTC) efforts - The company is focusing on social media channels like Facebook, TikTok, and Instagram for DTC marketing, targeting insulin users, particularly in the Medicare population [36][38] Question: Twist integration timeline - Integration work is ongoing, with most efforts focused on verification and validation of the integrated system, expected to be completed by Q3 [41][43] Question: Update on commercial plans for reimbursement - Management expects the majority of commercial plans to convert to the 365-day sensor by the end of the year, with significant progress already made [44][45]