CVRx Conference Call Summary Company Overview - **Company**: CVRx - **Industry**: Cardiovascular medical devices - **Product**: Barostim, a neuromodulation therapy for heart failure - **Annual Total Addressable Market (TAM)**: $2.2 billion [1][5] Key Points and Arguments Heart Failure Market - Heart failure leads to over 1 million hospitalizations, 1.3 million emergency room visits, and 8 million physician office visits in the U.S. annually, with spending projected to reach approximately $70 billion by the end of the decade [1] - Heart failure is a progressive disease with significant mortality rates, exceeding those of the top five cancers [1] Treatment Landscape - Current treatment involves quad therapy (four Class I drugs), but only 1% of patients reach therapeutic doses, and 40% discontinue at least one drug within the first year [3] - Patients express a preference for a higher quality of life over mere life extension [4] - Barostim targets the "forgotten middle" of heart failure patients, aiming to restore quality of life [4] Clinical Evidence and Efficacy - Barostim has shown a 68% improvement in New York Heart Class functional status and a 94% response rate among patients [10] - A real-world study indicated an 85% reduction in hospitalization rates post-implantation of Barostim [11] - The therapy operates by restoring signaling from baroreceptors to the brain, effectively reducing sympathetic tone and neurohormonal toxicity [8][9] Go-to-Market Strategy - CVRx is focusing on building a specialized sales organization and deepening adoption in targeted accounts rather than broad distribution [12][13] - The company has identified 300-400 centers in the U.S. with the highest potential for Barostim adoption based on patient volume and experience with similar devices [15][16] Barriers to Adoption - Key barriers include therapy awareness, clinical evidence, patient access, and reimbursement issues [18][19] - Significant outreach efforts are being made to educate referral physicians and advanced practice providers [20] Reimbursement Developments - Secured a permanent inpatient DRG reimbursement of $43,000 and an outpatient code at $45,000 [24] - Transitioning to a permanent category one procedural code on January 1, which will enhance payment certainty for surgeons and reduce prior authorization denials [25][26] Financial Performance - Reported Q3 revenue of $14.7 million, with guidance for Q4 revenue between $15 million and $16 million [27] - Gross margin reported at 87%, with a cash balance of $85 million [27] Additional Important Information - The therapy has a remarkable 97% freedom from complications during implantation [9] - The company is actively generating further clinical evidence to support the therapy's efficacy and safety [21][22][23]

Market Opportunity & Disease Burden - Heart failure affects over 6 million people in the U S [9], leading to over 1 1 million hospital discharges and over 1 3 million emergency room visits annually [11] - The annual costs associated with heart failure are expected to reach $70 billion by 2030 in the U S [11] - The U S annual net addressable market for Barostim is estimated at $2 2 billion, assuming an average selling price (ASP) of $29,000 [37] Barostim Therapy & Clinical Evidence - Barostim is presented as a neuromodulation therapy designed to improve heart failure symptoms [8] - Barostim implantation is a 60-minute procedure with a 97% freedom from major complications [46, 48] - Real-world evidence demonstrates an 85% relative reduction in hospital visits per year post-Barostim implant (average 1 92 years) compared to pre-implant (12 months) [67] Financial Performance & Guidance - Worldwide revenue for 2024 was $51 3 million, representing 31% growth [87, 88] - The gross margin for 2024 was 84% [87, 88] - The company's revenue guidance for full year 2025 is $55 0 – $58 0 million, with a gross margin of 83% – 84% and operating expenses of $95 0 – $98 0 million [90]