CVRx(US:CVRX)2025-11-06 12:25Revenue Performance - Revenue for the three months ended September 30, 2025, was $14.7 million, an increase of $1.3 million, or 10%, compared to the same period in 2024[86] - Revenue for the nine months ended September 30, 2025, was $40.6 million, an increase of $4.7 million, or 13%, compared to the same period in 2024[99] - Revenue generated in the U.S. was $36.9 million for the nine months ended September 30, 2025, an increase of $4.1 million, or 13%, over the prior year[100] - Revenue generated in Europe was $3.7 million for the nine months ended September 30, 2025, a $0.5 million increase, or 17%, compared to the same period in 2024[101] Gross Profit and Margins - Gross profit increased to $12.8 million for the three months ended September 30, 2025, a rise of $1.6 million, or 15%, with a gross margin of 87% compared to 83% in the prior year[91] - Gross profit for the nine months ended September 30, 2025, was $34.5 million, reflecting a $4.3 million increase, or 14%, over the prior year[103] Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $25.0 million, an increase of $0.9 million, or 4%, compared to the same period in 2024[85] - SG&A expenses decreased by $4.6 million, or 6%, to $66.5 million for the nine months ended September 30, 2025, primarily due to a decrease in non-cash stock-based compensation[107] Research and Development - Research and development expenses rose to $3.1 million, an increase of $0.6 million, or 26%, primarily due to higher compensation and consulting costs[92] Net Loss - Net loss for the nine months ended September 30, 2025, was $41.4 million, a decrease of $7.9 million, or 16%, compared to the net loss of $49.3 million in the same period in 2024[111] - The company anticipates continued net losses in the coming years due to planned investments in commercialization efforts[72] Cash and Financing - The company had cash and cash equivalents of $85.1 million as of September 30, 2025, down from $105.9 million at the end of 2024[111] - Cash used in operating activities for the nine months ended September 30, 2025, was $30.4 million, slightly lower than $31.1 million in the same period in 2024[118] - The company issued 543,462 shares of common stock under the ATM offering for gross proceeds of $9.5 million during the nine months ended September 30, 2025[113] - Interest expense increased by $1.5 million for the nine months ended September 30, 2025, driven by higher levels of borrowings under the Loan Agreement[108] Market Expansion and Strategy - U.S. sales accounted for $13.5 million, reflecting a 10% increase, driven by growth in the heart failure business and expansion into new sales territories[87] - The company had 250 active implanting centers in the U.S. as of September 30, 2025, up from 208 in the previous year[88] - The company plans to expand its U.S. commercial organization and increase awareness among physicians and patients to drive future revenue growth[77] Regulatory and Economic Factors - The Centers for Medicare & Medicaid Services released new Category I CPT codes for Barostim, expected to improve reimbursement predictability starting January 1, 2026[73] - Inflationary factors may adversely affect operating results, with potential impacts on gross margin and operating expenses if product selling prices do not increase accordingly[129] - Revenue and operating expenses incurred outside the U.S. are subject to foreign currency exchange rate fluctuations, particularly with the Euro, but realized gains and losses have not been material to financial statements[128] - The company is exposed to interest rate risk primarily related to cash equivalents and debt under the Loan Agreement, with no current plans to use financial derivatives[127]