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]

Core Insights - CVRx is a pioneering medical device company focused on treating advanced heart failure with its FDA-approved therapy [1] - The company is currently unprofitable due to significant investments in US sales and support infrastructure [1] Company Overview - CVRx operates in the medical device industry, specifically targeting advanced heart failure treatment [1] - The company has received FDA approval for its therapy, indicating regulatory validation of its product [1] Financial Performance - Despite its innovative approach, CVRx has not yet achieved profitability [1] - Heavy investments in infrastructure are a key factor contributing to the company's current financial status [1]

CVRx (CVRX) FY Conference Summary Company Overview - **Company**: CVRx - **Industry**: Medical Devices, specifically focusing on heart failure treatment - **Product**: Barostim, a neuromodulation therapy for heart failure Key Points and Arguments Market Opportunity - CVRx has developed the world's first neuromodulation therapy for heart failure, representing a **$2.2 billion** annual market opportunity with a defined patient population that has limited treatment options [3][10] - Heart failure affects over **6 million** Americans, leading to significant healthcare utilization, including **over 1 million** hospital discharges and **8 million** physician visits annually [4] Treatment Paradigm - Current treatment options primarily involve a regimen of four drugs (quad therapy), which have shown limited impact on quality of life, with only **1%** of patients reaching optimal doses [6][8] - The majority of heart failure patients (approximately **98%**) are not eligible for advanced therapies like LVAD or cardiac transplants, leading to a significant unmet need [5] Barostim Therapy - Barostim therapy addresses the unmet need in heart failure treatment by improving quality of life and exercise capacity, with **68%** of patients showing improvement in their New York Heart Association class status [16] - The therapy has demonstrated a **97%** freedom from major complications in clinical trials [13] - Real-world evidence shows an **85%** reduction in hospitalizations for patients receiving Barostim therapy [18] Commercial Strategy - CVRx aims to drive Barostim to become the standard of care through a focused commercial strategy that includes building a world-class sales team and developing sustainable adoption programs [19][20] - The company is targeting approximately **3,000 to 4,000** hospitals in the U.S. that have the potential for Barostim therapy adoption [23] Financial Performance - In 2024, CVRx reported worldwide revenue of **$51.3 million**, representing a **31%** growth, with U.S. heart failure revenue at **$46 million** and gross margins of **84%** [35] - For Q1 2025, the company reported revenue of **$12.3 million**, with a full-year guidance of **$55 million to $58 million** [36][37] Future Growth Potential - CVRx anticipates a sequential growth rate of **8% to 10%** from Q1 to Q4 2025, with long-term growth potential projected at **mid to high 20%** as the market opportunity expands [60][61] Additional Important Insights - The company is focusing on increasing awareness and evidence for Barostim therapy among healthcare providers, including advanced practice providers who frequently manage heart failure patients [26][29] - Significant changes in reimbursement policies are expected to improve patient access, including a proposed permanent outpatient code that could enhance the economic viability of the therapy [32][34] - The sales team has undergone significant changes, with **26%** of the team hired in 2025, indicating a focus on attracting experienced therapy development representatives [22][40] This summary encapsulates the critical aspects of CVRx's conference, highlighting the company's strategic direction, market potential, and financial outlook in the heart failure treatment landscape.

Company Overview - CVRx, Inc. is a commercial-stage medical device company focused on developing, manufacturing, and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases [3] - The company's flagship product, Barostim™, is the first FDA-approved medical technology that uses neuromodulation to alleviate symptoms in heart failure patients [3] - Barostim is an implantable device that delivers electrical pulses to baroreceptors in the carotid artery, aiming to restore balance to the autonomic nervous system and reduce heart failure symptoms [3] Recent Developments - CVRx management will present at the William Blair 45 Annual Growth Stock Conference on June 4, 2025, at 10:00 am Central Time via webcast [1] - A live audio webcast of the conference presentation will be accessible on the investor relations page of the company's website [2] Regulatory Approvals - Barostim has received FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. [3] - The device has also obtained the CE Mark for heart failure and resistant hypertension in the European Economic Area [3]

Group 1 - The company reported revenue of $12.3 million for Q1 2025, reflecting a 15% growth compared to the same quarter last year, aligning with preliminary results shared earlier [5] - The company aims to establish Barostim as the standard of care in its field [5] Group 2 - The earnings call included forward-looking statements regarding financial guidance, which are subject to change based on various risks and uncertainties [4] - The call featured participation from key executives, including the President and CEO, Kevin Hykes, and CFO, Jared Oasheim [3]

Revenue and Sales Performance - Revenue for the three months ended March 31, 2025, was $12.3 million, an increase of $1.6 million, or 15%, compared to the same period in 2024[84]. - U.S. sales accounted for $11.2 million, reflecting a 14% increase from $9.8 million in the prior year, driven by growth in the U.S. heart failure business[88]. - The number of active implanting centers in the U.S. increased to 227 as of March 31, 2025, up from 190 a year earlier[89]. Profitability and Expenses - Gross profit for the three months ended March 31, 2025, was $10.3 million, a 13% increase from $9.2 million in the same period in 2024, with a gross margin of 84%[91]. - Research and development expenses decreased by $0.5 million, or 18%, to $2.5 million for the three months ended March 31, 2025[92]. - Selling, general and administrative expenses decreased by $7.1 million, or 25%, to $21.2 million for the three months ended March 31, 2025[93]. - For the three months ended March 31, 2025, the net loss was $13.8 million, a decrease from a net loss of $22.2 million for the same period in 2024, representing a 37.9% improvement[98]. Cash Flow and Liquidity - Cash and cash equivalents as of March 31, 2025, were $102.7 million, down from $105.9 million as of December 31, 2024[98]. - Net cash used in operating activities for the three months ended March 31, 2025, was $12.8 million, compared to $10.9 million for the same period in 2024, indicating a 17.4% increase in cash outflow[104]. - Cash used in investing activities was $0.1 million for the three months ended March 31, 2025, down from $0.9 million in the same period in 2024[107]. - Net cash provided by financing activities for the three months ended March 31, 2025, was $9.6 million, a significant increase from $1.4 million in the same period in 2024[109]. Future Outlook and Funding - The company expects to continue incurring net losses for the next several years, which may require additional funding[71]. - Future liquidity and capital funding requirements will depend on factors including market acceptance of Barostim and costs of commercialization activities[101]. - The company has $50.0 million in outstanding Term Loans under the Loan Agreement as of March 31, 2025[99]. - The company raised $9.5 million through the issuance of 543,462 shares of common stock under the ATM offering during the three months ended March 31, 2025[100]. - The company has remaining capacity to issue and sell up to $6.7 million of additional shares of common stock under the ATM offering[100]. - The company anticipates incurring significant losses for at least the next several years[98]. Cost of Goods Sold and Interest Expense - Cost of goods sold increased by $0.4 million, or 26%, to $2.0 million for the three months ended March 31, 2025, driven by higher sales of Barostim[91]. - Interest expense increased by $0.5 million for the three months ended March 31, 2025, due to higher levels of borrowings under the Loan Agreement[95]. Commercial Strategy - The company plans to expand its U.S. commercial infrastructure by increasing its sales force and enhancing physician education on Barostim[67].

Core Viewpoint - CVRx reported a quarterly loss of $0.53 per share, which was better than the Zacks Consensus Estimate of a loss of $0.56, and an improvement from a loss of $1.04 per share a year ago [1] Financial Performance - The company posted revenues of $12.35 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 0.39% and showing an increase from $10.77 million in the same quarter last year [2] - Over the last four quarters, CVRx has surpassed consensus revenue estimates three times [2] Stock Performance - CVRx shares have declined approximately 41% since the beginning of the year, compared to a decline of 4.3% for the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is -$0.51 on revenues of $14.78 million, and for the current fiscal year, it is -$1.95 on revenues of $58.9 million [7] Industry Outlook - The Medical - Instruments industry, to which CVRx belongs, is currently ranked in the top 28% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $12.3 million, representing a 15% increase compared to Q1 2024 [5][19] - Gross profit was $10.3 million, a 13% increase year-over-year, with a gross margin of 84% [21] - Net loss for Q1 2025 was $13.8 million, or $0.53 per share, compared to a net loss of $22.2 million, or $1.04 per share in Q1 2024 [24] Business Line Data and Key Metrics Changes - Heart failure revenue in the US totaled $11.1 million for Q1 2025, up from $9.7 million in Q1 2024 [19] - The number of active implanting centers in the US increased to 227 from 223 as of December 31, 2024 [20] - Revenue generated in Europe was $1.1 million for Q1 2025, a 23% increase from the prior year [20] Market Data and Key Metrics Changes - The number of sales territories in the US decreased by three to a total of 45 [20] - Total revenue units in Europe increased to 59 for Q1 2025 from 44 in the prior year [21] Company Strategy and Development Direction - The company is focused on three strategic priorities: building a world-class sales organization, targeting high-potential centers, and addressing barriers to adoption [9][10][11] - A new compensation plan was introduced to align with a program-focused selling approach, generating enthusiasm among the sales team [10] - The company is working with CMS to create a level six neurostimulator APC to improve reimbursement for Barostim therapy [11][12] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about long-term prospects despite Q1 revenue performance, citing low exposure to macroeconomic uncertainties [26][27] - The company is seeing positive signs from the sales force realignment and expects productivity improvements as new hires gain experience [27][28] - Recent clinical evidence showing significant reductions in hospitalizations is expected to enhance adoption of Barostim therapy [28] Other Important Information - The company expects total revenue for 2025 to be between $55 million and $58 million, with Q2 guidance of $13 million to $14 million [25] - Cash and cash equivalents as of March 31, 2025, were $102.7 million [24] Q&A Session Summary Question: How much of the sales force changes were self-inflicted versus natural turnover? - The majority of changes were initiated by the company due to a reevaluation of the sales organization, not related to the new compensation plan [32] Question: What does the 2025 guidance imply regarding new center additions and overall utilization? - The company expects high single to low double-digit new center additions and plans to add around three territories per quarter throughout 2025 [34][35] Question: How much of the Q1 softness was due to seasonality versus sales team challenges? - The majority of the softness was attributed to disruptions in the sales team rather than seasonality [42] Question: What is the current mix of the sales team in terms of tenure? - Approximately 50% of territory managers were hired in the last 15 months, while the other 50% have been with the company longer [46] Question: Are there specific patient segments showing good signs of Barostim adoption? - There is no specific patient segment; adoption varies based on physician conservatism and treatment approaches [63] Question: What are the timelines for the potential randomized controlled trial (RCT)? - The company hopes to reach an agreement with the FDA in the next month or two and plans to engage CMS for reimbursement shortly thereafter [70][71]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $12.3 million, representing a 15% increase compared to Q1 2024 [4][17] - Gross profit was $10.3 million, a 13% increase year-over-year, with a gross margin of 84% [19] - Net loss for Q1 2025 was $13.8 million, or $0.53 per share, compared to a net loss of $22.2 million, or $1.04 per share in Q1 2024 [21] - Cash and cash equivalents as of March 31, 2025, were $102.7 million [21] Business Line Data and Key Metrics Changes - Heart failure revenue in the US totaled $11.1 million for Q1 2025, up from $9.7 million in Q1 2024 [17] - The number of active implanting centers in the US increased to 227 from 223 as of December 31, 2024 [18] - Revenue generated in Europe was $1.1 million for Q1 2025, a 23% increase year-over-year [18] Market Data and Key Metrics Changes - The number of sales territories in the US decreased by three to a total of 45 [18] - Total revenue units in Europe increased to 59 for Q1 2025 from 44 in the prior year [19] Company Strategy and Development Direction - The company is focused on three strategic priorities: building a world-class sales organization, targeting high-potential centers, and addressing barriers to adoption [7][8][9] - A new compensation plan was introduced to align with a program-focused selling approach, generating strong enthusiasm among the sales team [8] - The company is working with CMS to create a level six neurostimulator APC within the outpatient prospective payment system [9][10] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about long-term prospects despite Q1 revenue performance, citing low exposure to macroeconomic uncertainties [23][24] - The company expects to see productivity improvement and account stabilization as new sales representatives gain experience [5][16] - Management highlighted the importance of compelling clinical evidence, including an 85% reduction in heart failure hospitalizations, to drive adoption [25] Other Important Information - R&D expenses decreased by 18% to $2.5 million, driven by a reduction in consulting expenses [20] - The company plans to conduct a pragmatic randomized controlled trial to expand its total addressable market [15] Q&A Session Summary Question: How much of the sales force changes were self-inflicted versus natural turnover? - The majority of changes were initiated by the company due to a reevaluation of the sales organization [27][28] Question: What does the 2025 guidance imply regarding new center additions and overall utilization? - The company expects high single to low double-digit new center additions and plans to add around three territories per quarter [31][32] Question: How much of the softness in Q1 was related to seasonality versus sales rep challenges? - The majority of the softness was attributed to disruptions in the sales team rather than seasonality [37][38] Question: What is the current mix of the sales team in terms of tenure? - About 50% of territory managers were hired in the last 15 months, with the other half being more tenured staff [41] Question: Are there specific patient segments where Barostim adoption has shown good signs of penetration? - There is no specific patient segment; the adoption is more dependent on physician behavior and conservatism [60] Question: What are the timelines for the potential randomized controlled trial? - The company hopes to reach an agreement with the FDA in the next month or two and plans to enroll between 1,000 to 2,000 patients across 100 to 150 centers [68][69]