Tandem Diabetes Care(TNDM) - 2025 Q3 - Quarterly Results

Sales Performance - Worldwide sales for Q3 2025 increased to $249.3 million, up from $244.0 million in Q3 2024, with international sales of $73.6 million compared to $72.3 million[5] - The company achieved record third quarter sales both in the U.S. and internationally, with over 20,000 pumps shipped in the U.S. and more than 9,000 pumps shipped internationally[6] - Total GAAP sales in the United States for Q3 2025 reached $175.631 million, a 2% increase from $171.650 million in Q3 2024[24] - Total sales outside the United States for Q3 2025 were $73.622 million, a 2% increase from $72.321 million in Q3 2024[24] - Total non-GAAP worldwide sales for the nine months ended September 30, 2025, were $724.353 million, reflecting a 10% increase compared to $657.555 million in the same period of 2024[26] Financial Performance - GAAP gross profit for Q3 2025 was $134.3 million, resulting in a gross margin of 54%, an improvement from 51% in Q3 2024[7] - GAAP gross profit for Q3 2025 was $134.292 million, up from $124.653 million in Q3 2024, resulting in a gross margin of 54%[26] - The operating loss for Q3 2025 was $22.9 million, or negative 9% of sales, compared to a loss of $26.1 million, or negative 11% of sales in Q3 2024[7] - The net loss for Q3 2025 was $21.2 million, an improvement from a net loss of $23.3 million in Q3 2024[7] - The company reported a GAAP net loss of $21.165 million for Q3 2025, compared to a net loss of $23.251 million in Q3 2024[26] - Non-GAAP operating loss for the nine months ended September 30, 2025, was $164.433 million, an increase from a loss of $97.900 million in the same period of 2024[26] - Non-GAAP net loss for the nine months ended September 30, 2025, was $173.003 million, compared to a loss of $96.135 million in the same period of 2024[26] Guidance and Estimates - The company reaffirmed its full-year 2025 sales guidance at approximately $1.0 billion, with U.S. sales expected to be around $700 million and international sales approximately $300 million[10] - Gross margin for the full year 2025 is estimated to be between 53% and 54% of sales[10] - Adjusted EBITDA margin for the full year is estimated to be approximately negative 5% of sales, revised from approximately 3%[10] - Non-cash charges included in cost of goods sold and operating expenses are estimated to be approximately $115 million for the full year 2025[10] Other Developments - The company received FDA clearance for the extended wear use of the SteadiSet Infusion Set and filed for Android mobile control of the Tandem Mobi insulin delivery system[6] - The company recorded $11.2 million in impairment charges related to restructuring costs in Q1 2025[27] - The Tandem Choice program concluded in 2024, with no impact on sales for this program in 2025[24] - Free cash flow for Q3 2025 was $4.172 million, down from $21.542 million in Q3 2024[26]