Financial Data and Key Metrics Changes - In Q4 2025, total revenue was $16 million, a 4% increase year-over-year, while full-year revenue reached $56.7 million, reflecting a 10% growth [3][17] - Gross profit for Q4 was $13.8 million, an 8% increase, with gross margin rising to 86% from 83% a year ago [19] - Net loss for Q4 was $11.9 million, or $0.46 per share, compared to a net loss of $10.7 million, or $0.43 per share in Q4 2024 [21] Business Line Data and Key Metrics Changes - U.S. revenue was $14.9 million in Q4 2025, a 4% increase, with revenue units totaling 478, up from 460 in the prior year [17] - European revenue increased to $1.1 million, a 10% rise, with revenue units growing to 49 from 41 [18] Market Data and Key Metrics Changes - The addressable market for Barostim therapy is estimated at $10.5 billion, with only 1% penetration, indicating significant growth potential [5] - The initiation of the BENEFIT-HF trial could expand the addressable market to approximately $30 billion if successful [12] Company Strategy and Development Direction - The company focused on three strategic priorities: building a world-class sales organization, driving deep adoption in targeted centers, and reducing barriers to adoption [6] - Transition to Category I CPT codes is expected to improve patient access and reimbursement predictability, effective January 1, 2026 [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sales team's ability to execute and drive growth, despite a natural ramp-up period for new sales representatives [6][15] - The company anticipates total revenue for 2026 to be between $63 million and $67 million, with a gross margin of 84% to 86% [23] Other Important Information - The company amended its debt facility to extend the maturity date to 2031 and increase access to additional capital [14][22] - A new Chief Human Resources Officer was appointed, indicating ongoing organizational development [16] Q&A Session Summary Question: On the BENEFIT-HF trial strategy and revenue generation - Management indicated that the trial will involve a mix of existing and new commercial sites, with expected revenue from approximately 1,600 to 1,700 devices sold during the trial [26][28] Question: Growth of active accounts in Q4 - Management noted that while there was a net addition of accounts, the focus remains on deepening existing relationships, with expectations of adding around three active territories quarterly in 2026 [30][31] Question: Impact of the Category I code on treatment barriers - Management reported positive early signs of improved prior authorization approvals and expects this trend to continue as the transition progresses [36][39] Question: Path to profitability and cash management - The company has sufficient cash reserves and access to additional capital, with a focus on driving sales productivity to achieve profitability [72][74]
CVRx(CVRX) - 2025 Q4 - Earnings Call Transcript