Core Insights - Tandem Diabetes Care reported record fourth-quarter and full-year 2025 results, achieving over $1 billion in annual sales and marking a significant year for growth and profitability [4][7][3] Sales Performance - In Q4, Tandem achieved worldwide sales of $290 million, a 15% increase year over year, with U.S. sales rising 14% to $210 million, supported by over 27,000 pump shipments [2][4] - For 2025, total worldwide sales grew 12%, driven by a 10% increase in U.S. sales to $707 million and a 15% increase in international sales to $308 million [3][4] Profitability Metrics - The company reported a gross margin of 54% for the full year and 58% for Q4, reflecting a 3 percentage point improvement year over year [7][8] - Adjusted EBITDA was 11% of sales in Q4, a 10-percentage-point improvement from the previous year, and the company achieved its first positive operating margin since 2021 at 3% of sales in Q4 [8][7] Strategic Initiatives - Tandem is shifting its U.S. reimbursement strategy to a "pay-as-you-go" model, which is expected to enhance patient access and improve margins over time, despite creating near-term revenue recognition challenges [6][14] - The company is expanding its pharmacy access, with U.S. pharmacy sales nearly doubling sequentially to $16 million in Q4, representing 7% of U.S. sales [16][14] Product Development - Key product catalysts include the wider rollout of Control-IQ+, recent integrations with FreeStyle Libre 3 Plus, and a planned 510(k) submission for Mobi Tubeless, expected to launch in H2 2026 [5][12] - The company is preparing for a pivotal trial for a fully closed-loop system starting in 2026, supporting an FDA filing in 2027 [13][11] 2026 Outlook - For 2026, Tandem projects worldwide sales between $1.065 billion and $1.085 billion, incorporating $85 million to $95 million of headwinds related to business model changes [19][20] - U.S. pump shipments are expected to rise 10% to 11% year over year, with pharmacy sales anticipated to represent about 15% of total U.S. sales in 2026, up from 4% in 2025 [21][20]