Core Insights - CVRx reported Q2 2025 earnings with revenue of $13.6 million, a 15% increase year-over-year, surpassing analyst expectations of $13.29 million [1][5] - The company experienced a net loss of $14.7 million, or $(0.57) per share, which widened slightly compared to the previous year but improved on a per-share basis due to an increased share count [1][2] - Management narrowed its revenue guidance for fiscal 2025 to a range of $55.0 million to $57.0 million, indicating increased confidence in commercial results [1][12] Financial Performance - Revenue (GAAP) for Q2 2025 was $13.6 million, up from $11.8 million in Q2 2024, reflecting a 15.1% year-over-year change [2] - Gross profit reached $11.5 million with a gross margin of 84%, consistent with the previous year [2][7] - U.S. heart failure revenue was the largest contributor at $12.1 million, with unit sales increasing from 339 to 387 [5][6] Product and Market Development - Barostim, the company's leading product, is designed for heart failure treatment and has shown strong commercial progress despite heavy investments in sales and marketing [1][4] - The number of active implanting centers in the U.S. grew to 240, with 13 new centers added during the quarter [6] - European revenue increased by 19% to $1.3 million, although the number of implant units declined slightly, indicating variability in adoption [5][6] Clinical and Regulatory Updates - Real-world data presented at cardiology conferences showed significant reductions in heart failure hospital visits post-Barostim implantation, with reductions of 85% for heart failure and 86% for all causes [10] - The Centers for Medicare & Medicaid Services (CMS) proposed to retain Barostim as a covered outpatient procedure at a payment level of $45,000, providing stability for future revenue [8][9] Future Outlook - For the next quarter, revenue is expected to be in the range of $13.7 million to $14.7 million, suggesting continued double-digit growth [12] - Areas to monitor include the addition of new implanting centers, the effectiveness of the sales force, and the progress of a planned large randomized controlled trial (RCT) [13]

Company Performance - CVRx reported a quarterly loss of $0.57 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.52, but an improvement from a loss of $0.65 per share a year ago, indicating a -9.62% earnings surprise [1] - The company posted revenues of $13.59 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 0.96% and showing an increase from $11.81 million in the same quarter last year [2] - Over the last four quarters, CVRx has surpassed consensus revenue estimates four times, but has only done so for EPS estimates once [2] Stock Performance - CVRx shares have declined approximately 40.3% since the beginning of the year, contrasting with the S&P 500's gain of 6.1% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.47 on revenues of $14.54 million, and for the current fiscal year, it is -$1.97 on revenues of $56.54 million [7] Industry Outlook - The Medical - Instruments industry, to which CVRx belongs, is currently ranked in the bottom 37% of over 250 Zacks industries, suggesting potential challenges ahead [8] - The performance of CVRx's stock may be influenced by the overall outlook of the industry, as research indicates that the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8]

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]

[Executive Summary & Recent Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Recent%20Highlights) This section highlights robust Q2 2025 performance, including revenue growth, increased implant centers, and positive reimbursement updates [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CVRx CEO Kevin Hykes reported robust Q2 2025 performance, driven by sales team transformation, Barostim program growth, and progress in clinical evidence and reimbursement, including CMS's proposal to retain Barostim in APC 1580 with appropriate payment - CVRx achieved robust performance in Q2 2025, with sustained business momentum[3](index=3&type=chunk) - Sales team transformation is progressing, establishing sustainable Barostim programs at high-potential centers[3](index=3&type=chunk) - CMS proposed retaining the Barostim implant procedure in APC 1580 with appropriate outpatient payment, strengthening reimbursement status[3](index=3&type=chunk) [Key Operational & Financial Highlights](index=1&type=section&id=Key%20Operational%20%26%20Financial%20Highlights) CVRx reported Q2 2025 total revenue of **$13.6 million**, a **15%** increase, with U.S. HF revenue also up **15%**, and active U.S. implanting centers growing to **240** Q2 2025 Key Financial and Operational Highlights | Metric | Q2 2025 | Q2 2024 | Change | Change Rate | Source | | :-------------------------------- | :--------- | :--------- | :----- | :---------- | :--- | | Total Revenue | $13.6 Million | $11.8 Million | +$1.8 Million | +15% | [4, 6] | | U.S. Heart Failure (HF) Revenue | $12.1 Million | $10.5 Million | +$1.6 Million | +15% | [5, 6] | | U.S. Active Implanting Centers | 240 | 189 (based on 27% growth) | +51 | +27% | [6, 7] | - CMS proposed retaining the Barostim implant procedure in New Technology APC 1580, with outpatient payment of approximately **$45,000** for 2026[6](index=6&type=chunk) - CMS proposed favorable physician fee payment levels related to Category I CPT codes[6](index=6&type=chunk) - Brent Binkowski was appointed as the newly created Chief Operating Officer[6](index=6&type=chunk) [Second Quarter 2025 Financial and Operating Results](index=1&type=section&id=Second%20Quarter%202025%20Financial%20and%20Operating%20Results) This section details CVRx's Q2 2025 financial performance, including revenue, operating expenses, net loss, and cash position [Revenue Performance](index=1&type=section&id=Revenue%20Performance) CVRx achieved **$13.6 million** in total revenue for Q2 2025, a **15%** year-over-year increase, driven by U.S. and European contributions Q2 2025 Total Revenue | Metric | Q2 2025 (Million USD) | Q2 2024 (Million USD) | Change (Million USD) | Growth Rate | | :--- | :-------------------- | :-------------------- | :------------------- | :---------- | | Total Revenue | 13.6 | 11.8 | 1.8 | 15% | [U.S. Revenue](index=1&type=section&id=U.S.%20Revenue) U.S. revenue reached **$12.2 million** in Q2 2025, a **15%** increase, primarily from heart failure (HF) implants, driven by sales expansion and increased awareness Q2 2025 U.S. Revenue Details | Metric | Q2 2025 | Q2 2024 | Change | Growth Rate | | :------------------- | :--------- | :--------- | :----- | :---------- | | U.S. Total Revenue | $12.2 Million | $10.6 Million | +$1.6 Million | +15% | | U.S. HF Revenue | $12.1 Million | $10.5 Million | +$1.6 Million | +15% | | U.S. HF Revenue Units | 387 | 339 | +48 | +14.2% | - U.S. revenue growth was primarily driven by new sales territory expansion, new customer acquisition, and increased physician and patient awareness of Barostim[5](index=5&type=chunk) [Europe Revenue](index=2&type=section&id=Europe%20Revenue) Europe revenue grew **19%** to **$1.3 million** in Q2 2025, despite a slight decrease in total implant units Q2 2025 Europe Revenue Details | Metric | Q2 2025 | Q2 2024 | Change (Million USD) | Growth Rate | | :------------------- | :--------- | :--------- | :------------------- | :---------- | | Europe Revenue | $1.3 Million | $1.1 Million | +$0.2 Million | +19% | | Europe Total Revenue Units | 61 | 63 | -2 | -3.2% | [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Gross profit increased **16%** to **$11.5 million** with an **84%** margin, while R&D decreased **11%** and SG&A rose **11%** in Q2 2025 [Gross Profit & Margin](index=2&type=section&id=Gross%20Profit%20%26%20Margin) Gross profit for Q2 2025 increased **16%** to **$11.5 million**, maintaining an **84%** gross margin Q2 2025 Gross Profit and Margin | Metric | Q2 2025 | Q2 2024 | Change (Million USD) | Growth Rate | | :------- | :--------- | :--------- | :------------------- | :---------- | | Gross Profit | $11.5 Million | $9.9 Million | +$1.5 Million | +16% | | Gross Margin | 84% | 84% | 0% | 0% | [Research & Development](index=2&type=section&id=Research%20%26%20Development) R&D expenses decreased **11%** to **$2.5 million** in Q2 2025, primarily due to reduced compensation expenses Q2 2025 Research & Development Expenses | Metric | Q2 2025 | Q2 2024 | Change (Million USD) | Change Rate | | :------- | :--------- | :--------- | :------------------- | :---------- | | R&D Expenses | $2.5 Million | $2.8 Million | -$0.3 Million | -11% | - The decrease in R&D expenses was primarily driven by a **$0.3 million** reduction in compensation expenses[9](index=9&type=chunk) [Selling, General & Administrative](index=2&type=section&id=Selling%2C%20General%20%26%20Administrative) SG&A expenses increased **11%** to **$23.4 million** in Q2 2025, driven by higher compensation, travel, and stock-based compensation Q2 2025 SG&A Expenses | Metric | Q2 2025 | Q2 2024 | Change (Million USD) | Change Rate | | :------- | :--------- | :--------- | :------------------- | :---------- | | SG&A Expenses | $23.4 Million | $21.1 Million | +$2.2 Million | +11% | - The increase in SG&A expenses was primarily driven by a **$1.4 million** increase in compensation, an **$0.8 million** increase in travel expenses, and a **$0.4 million** increase in non-cash stock-based compensation, partially offset by a **$0.5 million** decrease in advertising expenses[10](index=10&type=chunk) [Other Income and Expenses](index=2&type=section&id=Other%20Income%20and%20Expenses) Interest expense increased by **$0.5 million** due to higher borrowings, while other net income rose by **$0.2 million** from interest on cash accounts in Q2 2025 Q2 2025 Other Income and Expenses | Metric | Q2 2025 (Million USD) | Q2 2024 (Million USD) | Change (Million USD) | | :----------- | :-------------------- | :-------------------- | :------------------- | | Interest Expense | 1.473 | 0.959 | +0.514 | | Other Income, Net | 1.110 | 0.944 | +0.166 | - The increase in interest expense was primarily driven by higher borrowing levels under the term loan agreement with Innovatus Capital Partners[11](index=11&type=chunk) - The increase in other net income was primarily driven by higher interest income from interest-bearing accounts[11](index=11&type=chunk) [Net Loss and EPS](index=2&type=section&id=Net%20Loss%20and%20EPS) Net loss for Q2 2025 expanded to **$14.7 million**, or **$0.57** per share, compared to a **$14.0 million** net loss, or **$0.65** per share, in the prior year Q2 2025 Net Loss and EPS | Metric | Q2 2025 | Q2 2024 | Change (Million USD) | | :--------------------------------- | :--------- | :--------- | :------------------- | | Net Loss | $14.7 Million | $14.0 Million | +$0.7 Million | | Net Loss Per Share | $0.57 | $0.65 | -$0.08 | | Weighted Average Shares Outstanding (Millions) | 26.1 | 21.6 | +4.5 | [Cash Position and Cash Flow](index=3&type=section&id=Cash%20Position%20and%20Cash%20Flow) Cash and cash equivalents stood at **$95.0 million** as of June 30, 2025, with net cash used in operating and investing activities decreasing to **$8.0 million** Q2 2025 Cash Position and Cash Flow | Metric | June 30, 2025 (Million USD) | June 30, 2024 (Million USD) | Change (Million USD) | | :--------------------------------- | :-------------------------- | :-------------------------- | :------------------- | | Cash and Cash Equivalents | $95.0 | $105.9 (December 31, 2024) | -$10.9 | | Net Cash Used in Operating and Investing Activities | $8.0 | $10.2 | -$2.2 | [Operational and Strategic Updates](index=2&type=section&id=Operational%20and%20Strategic%20Updates) This section covers growth in active implanting centers, positive reimbursement developments, and a key leadership appointment [Active Implanting Centers & Sales Territories](index=2&type=section&id=Active%20Implanting%20Centers%20%26%20Sales%20Territories) U.S. active implanting centers increased **27%** to **240**, and U.S. sales territories expanded to **47** as of June 30, 2025 Active Implanting Centers and Sales Territories | Metric | June 30, 2025 | June 30, 2024 | Change | Change Rate | | :------------------- | :------------ | :------------ | :----- | :---------- | | U.S. Active Implanting Centers | 240 | 189 (based on 27% growth) | +51 | +27% | | U.S. Sales Territories | 47 | 45 | +2 | +4.4% | | Europe Sales Territories | 5 | 5 | 0 | 0% | [Reimbursement Updates](index=3&type=section&id=Reimbursement%20Updates) CMS proposed retaining Barostim in New Technology APC 1580 with a **$45,000** outpatient payment for 2026, and Category I CPT codes are expected to improve predictability - CMS proposed retaining the Barostim implant procedure in New Technology APC 1580 for 2026, with outpatient payment of approximately **$45,000**[6](index=6&type=chunk)[14](index=14&type=chunk) - CMS is soliciting comments on establishing a Level 6 neurostimulator APC[14](index=14&type=chunk) - The transition to Category I CPT codes, effective January 2026, is expected to eliminate automatic denials and improve prior authorization predictability, with physician payment estimated at approximately **$550**[15](index=15&type=chunk) [Leadership Appointment](index=3&type=section&id=Leadership%20Appointment) Brent Binkowski was appointed Chief Operating Officer, joining in August to oversee R&D, operations, regulatory affairs, and quality functions - Brent Binkowski was appointed Chief Operating Officer and will join the company in August[6](index=6&type=chunk)[16](index=16&type=chunk) - He will be responsible for Research & Development, Operations, Regulatory Affairs, and Quality functions[16](index=16&type=chunk) - Binkowski brings over **20 years** of medical device leadership experience with expertise in implantable devices[16](index=16&type=chunk) [Business Outlook](index=3&type=section&id=Business%20Outlook) This section provides CVRx's updated full-year 2025 guidance and Q3 2025 revenue expectations [Full Year 2025 Guidance](index=3&type=section&id=Full%20Year%202025%20Guidance) CVRx narrowed its full-year 2025 guidance, projecting total revenue between **$55.0 million** and **$57.0 million**, gross margin of **83-84%**, and operating expenses of **$96.0 million** to **$98.0 million** Full Year 2025 Guidance | Metric | New Guidance | Old Guidance | | :----------- | :-------------------- | :-------------------- | | Total Revenue | $55.0 Million - $57.0 Million | $55.0 Million - $58.0 Million | | Gross Margin | 83% - 84% | - | | Operating Expenses | $96.0 Million - $98.0 Million | $95.0 Million - $98.0 Million | [Third Quarter 2025 Revenue Expectation](index=3&type=section&id=Third%20Quarter%202025%20Revenue%20Expectation) The company anticipates total revenue for the third quarter of 2025 to be between **$13.7 million** and **$14.7 million** Third Quarter 2025 Revenue Expectation | Metric | Expected Range | | :------- | :--------------- | | Total Revenue | $13.7 Million - $14.7 Million | [Company Information](index=4&type=section&id=Company%20Information) This section provides an overview of CVRx, its core product Barostim, forward-looking statements, and investor contacts [About CVRx, Inc.](index=4&type=section&id=About%20CVRx%2C%20Inc.) CVRx is a commercial-stage medical device company developing innovative neuromodulation solutions for cardiovascular disease patients, with Barostim™ as its FDA-approved core product - CVRx is a commercial-stage medical device company focused on providing innovative neuromodulation solutions for patients with cardiovascular diseases[20](index=20&type=chunk) - Barostim™ is the first FDA-approved medical technology to use neuromodulation to improve symptoms for heart failure patients[20](index=20&type=chunk) - Barostim delivers electrical impulses to baroreceptors in the carotid artery wall via an implantable device, aiming to restore autonomic nervous system balance and alleviate heart failure symptoms[20](index=20&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding future financial performance, growth strategies, and business prospects, subject to various known and unknown risks and uncertainties - This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995[21](index=21&type=chunk) - Forward-looking statements relate to future financial performance, growth strategies, industry trends, business prospects, and opportunities[21](index=21&type=chunk) - These statements are subject to known and unknown risks, uncertainties, and assumptions, including sustained losses, reliance on the single product Barostim, inadequate reimbursement coverage, competition, supply chain dependence, and regulatory approvals[22](index=22&type=chunk) [Investor Relations](index=5&type=section&id=Investor%20Relations) Contact information for investor and media relations is provided, including Mark Klausner, Mike Vallie, and Emily Meyers - Investor Contacts: Mark Klausner or Mike Vallie (ICR Healthcare), email: ir@cvrx.com, phone: 443-213-0501[23](index=23&type=chunk) - Media Contact: Emily Meyers (CVRx, Inc.), email: emeyers@cvrx.com, phone: 763-416-2853[23](index=23&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) This section presents CVRx's condensed consolidated balance sheets and statements of operations and comprehensive loss for Q2 2025 [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets were **$119.564 million**, with cash and cash equivalents at **$95.025 million**, and total liabilities at **$61.630 million** Condensed Consolidated Balance Sheets (Selected, in Thousands of USD) | Metric | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | 95,025 | 105,933 | | Total current assets | 116,145 | 129,813 | | Total assets | 119,564 | 133,414 | | Total current liabilities | 9,689 | 10,762 | | Long-term debt | 49,392 | 49,273 | | Total liabilities | 61,630 | 62,359 | | Total stockholders' equity | 57,934 | 71,055 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q2 2025, total revenue was **$13.589 million**, gross profit **$11.450 million**, operating loss **$14.376 million**, and net loss **$14.736 million**, or **$0.57** per share Condensed Consolidated Statements of Operations and Comprehensive Loss (Selected, in Thousands of USD) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--------------------------------- | :--------- | :--------- | :-------- | :-------- | | Revenue | 13,589 | 11,807 | 25,937 | 22,577 | | Cost of goods sold | 2,139 | 1,900 | 4,175 | 3,515 | | Gross profit | 11,450 | 9,907 | 21,762 | 19,062 | | Research and development expenses | 2,469 | 2,765 | 4,986 | 5,822 | | Selling, general and administrative expenses | 23,357 | 21,115 | 44,589 | 49,445 | | Operating loss | (14,376) | (13,973) | (27,813) | (36,205) | | Net loss | (14,736) | (14,029) | (28,502) | (36,215) | | Net loss per share (basic and diluted) | (0.57) | (0.65) | (1.10) | (1.69) |

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. is a commercial-stage medical device company focused on innovative neuromodulation solutions for cardiovascular diseases [3] - The company will present at the Canaccord Genuity 45th Annual Growth Conference on August 12, 2025, at 3:00 PM Eastern Time [1] - Barostim™ is the first FDA-approved medical technology using neuromodulation to alleviate heart failure symptoms [3] Company Overview - CVRx specializes in developing, manufacturing, and commercializing neuromodulation solutions for patients with cardiovascular diseases [3] - Barostim is an implantable device that delivers electrical pulses to baroreceptors in the carotid artery, aimed at restoring balance to the autonomic nervous system [3] - The device has received FDA Breakthrough Device designation and is approved for heart failure patients in the U.S., as well as certified under EU Medical Device Regulation [3] Conference Details - A live audio webcast of the conference presentation will be available on the investor relations page of the company's website [2]

Core Insights - CVRx, Inc. plans to release its second quarter 2025 financial and operating results on August 4, 2025, after market close [1] - A conference call will be held at 4:30 PM Eastern Time on the same day to discuss the results [1] Company Overview - CVRx 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] - The device has received FDA Breakthrough Device designation and is approved for use in heart failure patients in the U.S., as well as being compliant with EU Medical Device Regulation and holding CE Mark for heart failure and resistant hypertension in the European Economic Area [3]

Company Overview - CVRx shares experienced a significant increase of 19% to $8.45 in the last trading session, with a trading volume higher than average, contributing to a total gain of 25.4% over the past four weeks [1][2] Financial Performance - The company is projected to report a quarterly loss of $0.52 per share, reflecting a year-over-year improvement of 20%. Expected revenues are $13.46 million, which is a 14% increase compared to the same quarter last year [3] Market Sentiment - Investor optimism surged following the proposal from the Centers for Medicare and Medicaid Services (CMS) to include the Barostim implant procedure in the New Technology Ambulatory Payment Classification (APC) 1580, with an associated payment of approximately $45,000 for outpatient procedures [2] Earnings Estimates - The consensus EPS estimate for CVRx has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - CVRx operates within the Zacks Medical - Instruments industry, where another company, InspireMD, Inc., has shown a decline of 4.6% over the past month, closing at $2.34 [4]

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]