CVRx(CVRX) - 2025 Q2 - Quarterly Results

Executive Summary & Recent Highlights This section highlights robust Q2 2025 performance, including revenue growth, increased implant centers, and positive reimbursement updates CEO Commentary 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] - Sales team transformation is progressing, establishing sustainable Barostim programs at high-potential centers[3] - CMS proposed retaining the Barostim implant procedure in APC 1580 with appropriate outpatient payment, strengthening reimbursement status[3] Key Operational & Financial Highlights 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] - CMS proposed favorable physician fee payment levels related to Category I CPT codes[6] - Brent Binkowski was appointed as the newly created Chief Operating Officer[6] Second Quarter 2025 Financial and Operating Results This section details CVRx's Q2 2025 financial performance, including revenue, operating expenses, net loss, and cash position Revenue Performance 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 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] Europe Revenue 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 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 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 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] Selling, General & Administrative 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] Other Income and Expenses 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] - The increase in other net income was primarily driven by higher interest income from interest-bearing accounts[11] Net Loss and EPS 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 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 This section covers growth in active implanting centers, positive reimbursement developments, and a key leadership appointment Active Implanting Centers & Sales Territories 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 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][14] - CMS is soliciting comments on establishing a Level 6 neurostimulator APC[14] - 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] Leadership Appointment 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][16] - He will be responsible for Research & Development, Operations, Regulatory Affairs, and Quality functions[16] - Binkowski brings over 20 years of medical device leadership experience with expertise in implantable devices[16] Business Outlook This section provides CVRx's updated full-year 2025 guidance and Q3 2025 revenue expectations Full Year 2025 Guidance 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 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 This section provides an overview of CVRx, its core product Barostim, forward-looking statements, and investor contacts About CVRx, Inc. 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] - Barostim™ is the first FDA-approved medical technology to use neuromodulation to improve symptoms for heart failure patients[20] - 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] Forward-Looking Statements 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] - Forward-looking statements relate to future financial performance, growth strategies, industry trends, business prospects, and opportunities[21] - 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] Investor Relations 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] - Media Contact: Emily Meyers (CVRx, Inc.), email: emeyers@cvrx.com, phone: 763-416-2853[23] Financial Statements This section presents CVRx's condensed consolidated balance sheets and statements of operations and comprehensive loss for Q2 2025 Condensed Consolidated Balance Sheets 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 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) |