CVRx (CVRX)

• CVRx is undergoing a sales force transformation, with 50 active territories and plans to add approximately three per quarter, targeting $1.8 million in annual revenue per rep.
• The company has agreed with the FDA on a design for a new 2,500-patient Randomized Controlled Trial (RCT) to expand its indication, which is projected to triple its Total Addressable Market (TAM). This trial is estimated to cost $20 million-$30 million over four to six years.
• Reimbursement updates include permanent inpatient and outpatient coverage at $45,000 , and a new Category I code effective in about three weeks that will provide specific surgeon payment and streamline prior authorizations.
• CVRx reported a Q3 gross margin of 87% with an average selling price (ASP) of $32,000. The company holds $85 million in cash and expects at least three years of cash on the balance sheet, with the RCT's cash burn primarily in later years.

• CVRx anticipates conservative incremental revenue of approximately $1 million for Q4, attributing it to a sales force transformation initiated in Q1 2025. The company currently has 50 active territories and aims to reach 53 by the end of Q4, with a target of $1.8 million in annual revenue per rep.
• The company plans a significant 2,500-patient randomized controlled trial (RCT) to expand its indication, which is expected to cost $20 million-$30 million net over four to six years for enrollment and follow-up, potentially tripling its Total Addressable Market (TAM).
• CVRx has secured permanent inpatient reimbursement of $45,000 (an increase from $17,000) and is transitioning from a Category III to a Category I CPT code, which is projected to enhance prior authorization success rates and approval times.
• The company reported a Q3 gross margin of 87%, driven by an average selling price (ASP) of $32,000, and expects future gross margins to remain strong in the 85%-86% range. CVRx maintains a cash position of $85 million, providing at least three years of liquidity.

• CVRx's Barostim, a neuromodulation therapy for heart failure, targets a $2.2 billion annual TAM and has demonstrated significant clinical benefits, including a 94% patient response rate and an 85% reduction in hospitalization in real-world data.
• The company is implementing a revised go-to-market strategy, including replacing 70% of its sales team since early 2024 and focusing on deep adoption within 300-400 high-opportunity centers.
• Key patient access milestones include securing permanent inpatient DRG reimbursement of $43,000 and an outpatient code of $45,000, with a category one permanent procedural code effective January 1, 2026, expected to streamline surgeon payment and prior authorization approvals.
• For Q3 2025, CVRx reported $14.7 million in worldwide revenue and an 87% gross margin. The company provided Q4 2025 revenue guidance of $15 million to $16 million and full-year 2025 worldwide annualized revenue guidance of $55.6 million-$56.6 million, with operating expenses between $98 million and $99 million.

• CVRx's Barostim therapy addresses a $2.2 billion annual TAM for heart failure patients, demonstrating an 85% reduction in hospitalization in real-world data and a 94% patient response rate.
• The company has significantly revised its go-to-market strategy, rebuilding its sales team (replacing 45% in the last three quarters and 70% since early 2024) and focusing on deep adoption within 300-400 high-opportunity centers.
• Key milestones in patient access include securing permanent inpatient and outpatient reimbursement codes, and achieving a Category One permanent procedural code on January 1st, which will provide payment certainty for surgeons and prevent automatic prior authorization denials.
• For Q3, CVRx reported $14.7 million in worldwide revenue and an 87% gross margin, with Q4 2025 revenue guidance between $15 million and $16 million, and full-year 2025 worldwide annualized revenue guidance of $55.6 million-$56.6 million.

• CVRx's Barostim therapy targets a $2.2 billion annual Total Addressable Market for heart failure patients, with real-world data demonstrating an 85% reduction in hospitalization.
• The company has significantly revised its go-to-market strategy, replacing 45% of its sales team in the last three quarters and 70% since the start of 2024, to focus on deep adoption within 300-400 high-opportunity centers.
• Key patient access milestones include securing a permanent inpatient DRG for $43,000 and an outpatient code for $45,000, with a permanent Category One procedural code effective January 1 to formalize surgeon payment and prevent automatic prior authorization denials.
• For Q3, CVRx reported worldwide revenue of $14.7 million, an 87% gross margin, and a cash balance of $85 million.
• The company guides for Q4 revenue between $15 million and $16 million, and worldwide annualized revenues of $55.6 million-$56.6 million for the full year, with gross margins of 85%-86% and operating expenses between $98 million and $99 million.

CVRx delivered a strong third quarter in 2025, marked by double-digit revenue growth and an expanded commercial footprint. Key financial figures and guidance are detailed in the table below.

• CVRx achieved double-digit revenue growth in Q3 2025 year-over-year, driven by continued expansion in the U.S. heart failure business and increased awareness of Barostim. The company also saw an improvement in its gross margin.
• The company updated its full-year 2025 revenue and gross margin guidance, and provided Q4 2025 revenue expectations.
• Significant progress was made in reimbursement, with the finalization of a Category One CPT code effective January 1, 2026, which is expected to eliminate experimental denials and improve prior authorization predictability. CMS also proposed maintaining Barostim in new technology APC 1580 with a payment of approximately $45,000 for outpatient procedures.
• CVRx submitted an IDE application for a new randomized controlled trial in mid-October, aiming to triple its Total Addressable Market (TAM) by expanding patient criteria. The company anticipates mid-teens sales growth for 2026, accelerating from 2025 growth rates.

• Total revenue for Q3 2025 was $14.7 million, representing a 10% increase over the prior year quarter.
• The company achieved a gross profit of $12.8 million and an improved gross margin of 87% for the third quarter of 2025.
• Net loss for Q3 2025 was $12.9 million, or $0.49 per share.
• CVRx updated its full-year 2025 guidance, now expecting total revenue between $55.6 million and $56.6 million and a gross margin between 85% and 86%.
• U.S. active implanting centers grew to 250 as of September 30, 2025, an increase of 20% since September 30, 2024, and CMS finalized favorable physician fee payment levels for Category I CPT codes effective 2026.

• CVRx reported total revenue of $14.7 million for the third quarter of 2025, marking a 10% increase over the prior year quarter. Gross profit grew by 15% to $12.8 million, with the gross margin improving to 87% for the three months ended September 30, 2025. The net loss for the quarter was $12.9 million, or $0.49 per share.
• U.S. revenue for Q3 2025 was $13.5 million, also a 10% increase year-over-year. Active implanting centers in the U.S. grew to 250 as of September 30, 2025, an increase of 20% since September 30, 2024.
• CMS published the final rule to assign favorable physician fee payment levels in connection with the Category I CPT codes, which are set to take effect in 2026.
• For the full year 2025, CVRx updated its guidance, now expecting total revenue between $55.6 million and $56.6 million and a gross margin between 85% and 86%. The company also anticipates total revenue between $15.0 million and $16.0 million for the fourth quarter of 2025.