Revenue Growth - Revenue for the nine months ended September 30, 2025, was $10,121, a 56% increase from $6,504 in 2024[69] - For the three months ended September 30, 2025, revenue reached $5,289, representing an 87% increase from $2,832 in 2024[69] Profit and Loss - Gross profit for the nine months ended September 30, 2025, was $7,402, an 82% increase from $4,075 in 2024, with a gross margin of 73%[70] - The net loss attributed to shareholders for the nine months ended September 30, 2025, was $34,395, a 50% increase from $22,869 in 2024[70] - For the nine months ended September 30, 2025, the net loss was $34,395 and net cash used in operating activities was $31,641[90] Operating Expenses - Operating expenses for the nine months ended September 30, 2025, totaled $41,287, a 43% increase from $28,792 in 2024[70] - Research and development expenses for the nine months ended September 30, 2025, increased by $4,008, or 33%, to $16,324 compared to $12,316 in 2024[80] - Selling, general and administrative expenses for the nine months ended September 30, 2025, were $24,963, a 52% increase from $16,476 in 2024[70] - SG&A expenses for the three months ended September 30, 2025 increased by $806, or 12%, to $7,426 compared to $6,620 for the same period in 2024[83] - SG&A expenses for the nine months ended September 30, 2025 increased by $8,487, or 52%, to $24,963 compared to $16,476 for the same period in 2024[84] Cash Flow and Financing - As of September 30, 2025, cash was $24,826 compared to $54,912 as of December 31, 2024[88] - Net finance income decreased by $194 to $910 during the nine months ended September 30, 2025, compared to $1,104 during the same period in 2024[87] - The company projects to be in violation of a financial covenant under the CIBC Credit Agreement by June 30, 2026[98] - The company intends to seek additional financing from investors or other sources of capital to fund operations over the next year[91] Regulatory Approvals - The TULSA-PRO system is CE marked, Health Canada approved, and 510(k) cleared by the U.S. FDA, indicating regulatory compliance for commercialization[66] - Sonalleve has received approval from the China National Medical Products Administration for the treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption[67] Revenue Model - The company employs a hybrid recurring revenue model in the U.S. for TULSA-PRO, combining one-time payments with ongoing service charges[71] Use of Proceeds - Total spending of proceeds from the 2024 Public Offering as of September 30, 2025 was $36,132, with $25,214 allocated for TULSA-PRO commercialization[94]
Profound(PROF) - 2025 Q3 - Quarterly Report