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]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $14.7 million, an increase of $1.3 million or 10% year-over-year [11] - Gross profit was $12.8 million, up $1.5 million or 15% year-over-year, with a gross margin increase to 87% from 83% [12][13] - Net loss was $12.9 million or $0.49 per share, compared to a net loss of $13.1 million or $0.57 per share in Q3 2024 [16] - Cash and cash equivalents stood at $85.1 million as of September 30, 2025 [16] Business Line Data and Key Metrics Changes - U.S. revenue was $13.5 million, a 10% increase, with 420 revenue units sold compared to 394 in Q3 2024 [11][12] - Active implanting centers in the U.S. increased to 250 from 240 in the previous quarter [11] - European revenue was $1.2 million, a 12% increase, but total revenue units decreased to 50 from 56 [12] Market Data and Key Metrics Changes - The company added 10 net new centers in Q3 2025, with over 20% of active implanting centers achieving three or more implants [4][5] - The average selling price (ASP) for the quarter was over $31,000, up from just below $30,000 in Q3 2024 [33] Company Strategy and Development Direction - The company is focused on building a world-class sales organization and expanding its commercial footprint [3][4] - Targeting high-potential centers for sustainable programs and implementing a best practice playbook for therapy adoption [4] - The transition to a Category One CPT code effective January 1, 2026, is expected to improve reimbursement predictability and support therapy adoption [6][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sales team's productivity and the positive signals from payers [18] - The company anticipates mid-teens growth in 2026, with potential for higher growth rates in the mid-20% range by 2027 and beyond [22][36] - The management highlighted the importance of reimbursement advancements and clinical evidence in driving future growth [6][9] Other Important Information - R&D expenses increased by $0.6 million or 26% to $3.1 million, driven by higher compensation and consulting expenses [13] - The company plans to refresh its registration statement in connection with the filing of its Q3 10Q [17] Q&A Session Summary Question: Guidance and Sales Reps Productivity - Management noted that while Q3 results were strong, they are cautious about future guidance due to ongoing productivity ramp-up of new sales reps [20][21] Question: 2026 Growth Projections - Management is comfortable with mid-teens growth expectations for 2026, with potential for exceeding those expectations based on various factors [22][36] Question: Sales Force Productivity - Management indicated that while new reps are becoming productive, full productivity is still being developed, with a typical ramp-up period of 6-12 months [25][26] Question: Reimbursement Changes - The transition to Category One CPT code is expected to reduce prior authorization friction and improve approval rates [28][29] Question: Gross Margin Insights - The increase in gross margin was attributed to a mix of higher average selling prices and improved manufacturing efficiencies [32][33] Question: RCT Trial and Enrollment - The company is planning a significant randomized controlled trial with approximately 2,000 patients, which could expand the total addressable market [44][49] Question: Operating Expenses Management - Management expects operating expenses to grow at a lower rate than revenue, indicating operational leverage [63]

Core Insights - CVRx, Inc. reported a solid performance in Q3 2025, with a revenue increase of 10% year-over-year, reaching $14.7 million, driven by growth in the U.S. heart failure business and improved commercial strategies [4][10]. Financial Performance - Total revenue for Q3 2025 was $14.7 million, an increase of $1.3 million, or 10%, compared to Q3 2024 [4][10]. - U.S. revenue was $13.5 million, also reflecting a 10% increase from the previous year, with 420 revenue units sold compared to 394 in Q3 2024 [5][10]. - European revenue reached $1.2 million, a 12% increase from the prior year, although total revenue units decreased from 56 to 50 [7][10]. - Gross profit for Q3 2025 was $12.8 million, up 15% from $11.1 million in Q3 2024, with a gross margin improvement to 87% from 83% [8][10]. - R&D expenses rose by 26% to $3.1 million, driven by increased compensation and consulting costs [9][10]. - SG&A expenses increased slightly by 1% to $21.9 million, influenced by higher consulting and travel expenses [10][11]. - The net loss for Q3 2025 was $12.9 million, or $0.49 per share, compared to a net loss of $13.1 million, or $0.57 per share, in Q3 2024 [13][10]. Operational Highlights - The number of active implanting centers in the U.S. grew to 250, a 20% increase since September 2024, with the number of sales territories increasing to 50 [6][10]. - The company received favorable updates from CMS regarding the transition to Category I CPT codes, which is expected to enhance patient access and adoption of their products [3][10]. Business Outlook - For the full year of 2025, CVRx expects total revenue between $55.6 million and $56.6 million, with a gross margin between 85% and 86% [15][19]. - The company anticipates Q4 2025 revenue to be between $15.0 million and $16.0 million [15].

Summary of Key Points from J.P. Morgan MedTech Conference Call Industry Overview - The MedTech sector is experiencing earnings reports from various companies, including large-cap firms like BDX (Becton Dickinson) and ZBH (Zimmer Biomet), as well as several SMid-cap companies such as CVRX, INSP, and others [1][31]. Company-Specific Insights CVRX (CVRX) - CVRX has a strong track record, beating top-line expectations 87% of the time, but has seen an average stock reaction of down 2% post-report [2]. - Guidance for 2Q has been lowered to $55-58 million due to salesforce disruptions, with a forecast of $13.5 million in sales for 2Q, representing a 14% increase year-over-year [2]. Inspire Medical (INSP) - Inspire has beaten top-line expectations 86% of the time, with a positive stock reaction 75% of the time, averaging a +4.9% move [3]. - The focus is on the launch of Inspire 5, with expectations for a ramp-up in the second half of the year [3]. Bioventus (BVS) - Bioventus has beaten on sales 78% of the time, with expectations for an in-line to slightly better quarter, forecasting sales of $146 million [8]. - The company is cautious due to mixed orthopedic prints and lower correlation with large joint manufacturers [8]. Ceribell (CBLL) - Forecasting sales of $20.6 million for 2Q, representing a 35% increase, with gross margin expected at 85.5% [9]. - The company is viewed positively as a high-quality SMid-cap, despite the sector being out of favor [9]. Becton Dickinson (BDX) - BDX has beaten top-line expectations 67% of the time, with a significant concern among investors due to a lack of pre-announcement and potential fundamental weaknesses [12][14]. - The Street forecasts organic growth of +2.9% for the upcoming quarter, which is below previous expectations [14]. Enovis (ENOV) - Enovis has beaten on the bottom line 90% of the time, with expectations for a small beat-and-raise against the Street [18]. - The company is facing pressure from a short report and mixed orthopedic prints from competitors [18]. Insulet (PODD) - Insulet has a strong record, beating top-line expectations 93% of the time, with a forecast of $618.8 million in total revenue for 2Q, a 27% increase [22][23]. - The company is viewed as a top pick due to its competitive advantages in patch pump manufacturing [23]. Zimmer Biomet (ZBH) - Zimmer Biomet has beaten revenues 60% of the time, but investors are frustrated with inconsistent performance [29][30]. - The company is expected to deliver a clean quarter with a slight beat and guidance raise, but there are concerns about the high-end of its growth range [30]. Additional Insights - The overall sentiment in the MedTech sector is cautious, with many companies facing challenges such as salesforce disruptions, mixed orthopedic trends, and investor skepticism [6][14][18]. - There is a notable trend of fund flows out of healthcare and MedTech, impacting stock performance across the sector [23]. Conclusion - The MedTech sector is poised for a series of earnings reports, with varying expectations across companies. While some firms like Insulet and CVRX show strong potential, others like Becton Dickinson and Zimmer Biomet face significant investor scrutiny and challenges. The overall market sentiment remains cautious, reflecting broader economic uncertainties and sector-specific dynamics.

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $13.6 million, a 15% increase compared to the same quarter last year [5][18] - U.S. heart failure revenue was $12.2 million, also a 15% increase year-over-year [19] - Gross profit increased to $11.5 million, a 16% increase from the prior year [21] - Net loss for the quarter was $14.7 million, or $0.57 per share, compared to a net loss of $14 million, or $0.65 per share, in the prior year [23][24] Business Line Data and Key Metrics Changes - Heart failure revenue units in the U.S. increased to 3.87 million from 3.39 million year-over-year [19] - The number of active implanting centers in the U.S. rose to 240 from 227 at the end of Q1 2025 [6][20] - The number of sales territories in the U.S. increased to 47 from 45 at the end of Q1 2025 [6][20] - Revenue in Europe was $1.3 million, a 19% increase year-over-year, although total revenue units in Europe decreased to 61 from 63 [21] Market Data and Key Metrics Changes - The company expanded its U.S. sales territories and active implanting centers, indicating growth in market presence [6][20] - The reimbursement strategy is advancing, with CMS proposing to maintain the Barostim implant procedure payment at approximately $45,000 [12][13] Company Strategy and Development Direction - The company is focusing on sustainable Barostim programs and optimizing onboarding and training for new territory managers [8][11] - The strategy includes targeting Tier one and Tier two accounts while also exploring opportunities in Tier three and four accounts [10][11] - The company is committed to building clinical evidence and increasing awareness of Barostim through educational programs [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the direction of the business and the momentum being built, particularly in sales force stabilization and reimbursement improvements [26] - The company anticipates continued growth driven by strong fundamentals and a predictable therapy [26] - Management acknowledged ongoing challenges in changing medical practices but believes reimbursement improvements will significantly reduce friction [84][85] Other Important Information - The company appointed Brent Binkowski as Chief Operating Officer, effective August, to oversee research and development, operations, regulatory affairs, and quality [27] - The company narrowed its revenue guidance for the full year of 2025 to between $55 million and $57 million [25] Q&A Session Summary Question: Can you walk us through the narrowed guidance and how it contemplates the ramp of new territory managers? - Management explained that the narrowed guidance reflects a slight adjustment and focuses on getting the new team productive as quickly as possible [30] Question: How do you measure the success of Tier three and four accounts? - Management clarified that they track data internally and provide it to reps as part of their playbook, helping them understand which accounts may be more receptive [32] Question: What are the expectations for the Salesforce reorganization and productivity ramp? - Management indicated that they expect to activate more territories and see productivity ramp up as new reps become more effective [38] Question: What are the implications of the gross margin guidance? - Management stated that the gross margin has been consistent and they expect to maintain similar numbers in Q3 and Q4 [42] Question: Can you elaborate on the reimbursement process and the transition to a category one code? - Management explained that the transition to a category one code will improve approval rates and predictability for procedures, moving away from the experimental status of category three [56][58] Question: What are the expected challenges for next year regarding adoption? - Management identified ongoing barriers related to reimbursement, awareness, and evidence generation as challenges that will persist [85]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $13.6 million, representing a 15% increase compared to the same quarter last year [4][18] - U.S. heart failure revenue was $12.2 million, also a 15% increase year-over-year [5][19] - Gross profit increased to $11.5 million, a 16% rise from the prior year [21] - Net loss for the quarter was $14.7 million, or $0.57 per share, compared to a net loss of $14 million, or $0.65 per share, in the prior year [23][24] Business Line Data and Key Metrics Changes - Heart failure revenue units in the U.S. increased from $3.39 million to $3.87 million year-over-year [19] - The number of active implanting centers in the U.S. rose to 240 from 227 at the end of Q1 2025 [5][20] - The number of sales territories in the U.S. increased to 47, up from 45 at the end of Q1 2025 [5][20] - Revenue generated in Europe was $1.3 million, a 19% increase year-over-year, despite a decrease in total revenue units [21] Market Data and Key Metrics Changes - The company is focusing on expanding its presence in Tier one and Tier two accounts while also exploring opportunities in Tier three and four accounts [8][10] - The sales force transformation is progressing, with over 35% of territory managers hired since January 1, 2025 [6][7] Company Strategy and Development Direction - The company is shifting focus from hiring to optimizing onboarding and training to increase productivity among new territory managers [7] - A refined approach to developing sustainable Barostim programs is showing positive results, targeting centers based on potential indicators [7][10] - The company is actively working on reimbursement strategies to reduce barriers to adoption for its therapy [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the direction of the business, highlighting the positive developments in reimbursement and clinical evidence [25] - The company anticipates continued growth as it moves towards making Barostim a standard of care for heart failure treatment [25] - Management acknowledged ongoing challenges in changing medical practices but believes reimbursement improvements will significantly aid adoption [85] Other Important Information - The company appointed Brent Binkowski as Chief Operating Officer, effective August 2025, to oversee research and development, operations, regulatory affairs, and quality [26] - The transition to Category one CPT codes in January 2026 is expected to enhance commercial efforts and improve prior authorization predictability [12] Q&A Session Summary Question: Can you walk us through the narrowed guidance and how it contemplates the ramp of new territory managers? - Management indicated that the narrowed guidance reflects a slight adjustment and focuses on getting new team members productive as quickly as possible [29] Question: How do you measure the success of Tier three and four accounts? - Management clarified that internal data tracking is used to guide reps on which accounts to target, rather than placing the burden on the reps themselves [31] Question: What is the expected ramp and cadence for the Salesforce reorganization? - Management expects to activate more territories quarterly and sees productivity ramping up as new hires become more effective [36] Question: Can you elaborate on the gross margin guidance? - Management stated that the gross margin has been consistent and does not anticipate significant changes in the second half of the year [40] Question: What are the expected challenges in the future? - Management identified ongoing barriers related to reimbursement, awareness, and evidence generation as challenges that will persist [85]

Core Insights - CVRx, Inc. reported solid second quarter results for 2025, with a revenue increase of 15% year-over-year, reflecting strong business momentum and sales force transformation [3][4][9]. Financial Performance - Total revenue for Q2 2025 was $13.6 million, up from $11.8 million in Q2 2024, marking a $1.8 million increase [4][27]. - U.S. revenue was $12.2 million, also a 15% increase from $10.5 million in the same quarter last year [5][27]. - Heart Failure (HF) revenue in the U.S. reached $12.1 million, a 15% increase compared to $10.5 million in Q2 2024, with HF revenue units rising from 339 to 387 [5][9]. - European revenue was $1.3 million, a 19% increase from $1.1 million in Q2 2024, despite a slight decrease in revenue units from 63 to 61 [7][27]. - Gross profit for Q2 2025 was $11.5 million, a 16% increase from $9.9 million in Q2 2024, maintaining a gross margin of 84% [8][27]. - R&D expenses decreased by 11% to $2.5 million, while SG&A expenses increased by 11% to $23.4 million [8][9][10]. - The net loss for Q2 2025 was $14.7 million, or $0.57 per share, compared to a net loss of $14.0 million, or $0.65 per share, in Q2 2024 [12][27]. Operational Highlights - As of June 30, 2025, CVRx had 240 active implanting centers in the U.S., a 27% increase from 189 centers a year prior [6][9]. - The number of U.S. sales territories increased to 47, with two new territories added during the quarter [6][9]. - The company is advancing its clinical evidence strategy and strengthening its reimbursement position, with CMS proposing to keep Barostim in APC 1580 for 2026 [3][14]. Reimbursement Updates - CMS proposed to maintain the Barostim implant procedure in the New Technology APC 1580 for 2026, with an outpatient payment of approximately $45,000 [14][15]. - The transition to Category I CPT codes in January 2026 is expected to enhance reimbursement predictability and eliminate automatic denials associated with Category III codes [15]. Leadership Changes - Brent Binkowski has been appointed as the Chief Operating Officer, bringing over 20 years of experience in medical devices [16]. Business Outlook - For the full year of 2025, CVRx expects total revenue between $55.0 million and $57.0 million, with Q3 revenue projected between $13.7 million and $14.7 million [17][18].

Core Insights - CVRx, Inc. announced that the Centers for Medicare and Medicaid Services (CMS) proposed to maintain the Barostim implant procedure under the New Technology Ambulatory Payment Classification (APC) 1580, with an outpatient payment of approximately $45,000 [1] - The proposal follows positive reimbursement developments, including Barostim's assignment to a higher paying MS-DRG for inpatient procedures and its transition from Category III to Category I CPT codes for physician payments starting January 1, 2026 [2] - The updates in reimbursement are expected to enhance access to Barostim for patients with heart failure, supporting its broader market adoption and long-term growth [3] Company Overview - CVRx is a commercial-stage medical device company focused on innovative neuromodulation solutions for cardiovascular diseases [4] - Barostim is the first FDA-approved medical technology that uses neuromodulation to alleviate symptoms in heart failure patients, delivering electrical pulses to baroreceptors in the carotid artery [4] - Barostim has received FDA Breakthrough Device designation and is compliant with EU Medical Device Regulation, holding CE Mark approval for heart failure and resistant hypertension in the European Economic Area [4]

Barostim Device & Clinical Trial Results - Barostim improves exercise capacity in HFrEF patients, showing a 19%-20% improvement versus the control arm in clinical trials[19, 37] - The BeAT-HF pivotal trial demonstrated a clinically meaningful improvement of 60 meters in exercise capacity and a -14 point change in quality of life for Barostim patients[27, 28] - The BeAT-HF pivotal trial showed a 25% reduction in NT-proBNP levels with Barostim, which is considered clinically meaningful[34] Market Opportunity & Patient Identification - The initial annual market opportunity for Barostim in the U S and the five largest EU countries is estimated at $2 9 billion[44] - The U S market consists of 6 3 million patients, while the 5 EU countries have 8 6 million patients[42] - The initial addressable patient incidence rate is 55,000 patients per year in the U S and 61,000 patients per year in the 5 EU countries[42] - Patient identification for Barostim is straightforward, based on NYHA II/III symptoms, LVEF ≤ 35%, and NT-proBNP < 1600pg/ml[47] Commercial Strategy & Financial Performance - The company aims to add 3 new account managers every quarter to create new territories and activate implanting centers[58] - The goal is to have 5 active implanting centers per territory, with each center implanting 12 Barostim units per year[58] - Full year 2022 revenue was $7 0 million - $7 1 million, with US HF revenue at $5 9 million (+118%)[67] - The company projects total revenue between $35 0 million and $38 0 million for the full year of 2023[68]

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]