CVRx Reports First Quarter 2025 Financial and Operating Results
- Revenue growth of 15% YoY to $12.3 million
- U.S. Heart Failure revenue increased 14% to $11.1 million
- Active implanting centers grew 19% to 227 centers
- Real-world evidence showed 85% reduction in heart failure hospital visits
- Strong cash position of $102.7 million
- Net loss of $13.8 million in Q1 2025
- Revenue growth didn't meet company expectations
- U.S. sales territories decreased by three to 45
- Increased interest expense due to higher borrowings
- Net cash burn increased to $12.9 million from $11.8 million YoY
Insights
CVRx shows 15% revenue growth but below expectations; improved net loss amid strong clinical results; outlook suggests accelerating growth ahead.
CVRx's Q1 2025 results present a mixed financial picture with some encouraging clinical developments. Total revenue reached
The financial metrics reveal some important trends. Net loss improved significantly to
The most compelling aspect of CVRx's story comes from new clinical evidence showing Barostim's significant impact on reducing hospitalizations. Real-world data demonstrated an
Looking ahead, management's guidance suggests accelerating growth, with projected Q2 revenue of
The conflicting signals of reduced U.S. sales territories (down 3 to 45) while simultaneously adding new sales representatives creates some uncertainty about the sales strategy execution. However, the compelling clinical evidence combined with expanding implanting centers provides a foundation for potential accelerated growth if new sales representatives become productive as anticipated.
MINNEAPOLIS, May 08, 2025 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced its financial and operating results for the first quarter of 2025.
Recent Highlights
- Total revenue for the first quarter 2025 was
$12.3 million , an increase of15% over the prior year quarter - U.S. Heart Failure (HF) revenue for the first quarter of 2025 was
$11.1 million , an increase of14% over the prior year quarter - Active implanting centers in the U.S. grew to 227, an increase of
19% since March 31, 2024 - Real-world evidence presented at the 2025 THT conference and published in the Journal of Cardiac Failure demonstrated large and statistically significant reductions in hospital visits for patients treated with Barostim
"We're encouraged about the momentum building in our business as we move into the second quarter," said Kevin Hykes, President and Chief Executive Officer of CVRx. "While revenue growth in the first quarter didn't meet our expectations, we added a significant number of new sales representatives, and are very pleased with the talent we have attracted to the organization. As these reps are still in the early stages of building their territories, we expect their contributions to grow as the year progresses. We continue to support these commercial initiatives by advancing our growing body of clinical evidence, highlighted by our recently published hospitalization data from the Premier Healthcare Database, which further reinforced Barostim's value proposition in the treatment of heart failure patients."
First Quarter 2025 Financial and Operating Results
Revenue was
Revenue generated in the U.S. was
As of March 31, 2025, the Company had a total of 227 active implanting centers in the U.S., as compared to 223 as of December 31, 2024. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. The number of sales territories in the U.S. decreased by three to a total of 45 during the three months ended March 31, 2025.
Revenue generated in Europe was
Gross profit was
R&D expenses decreased
SG&A expenses decreased
Interest expense increased
Other income, net increased
Net loss was
As of March 31, 2025, cash and cash equivalents were
Real-World Evidence Supporting Barostim
In February 2025, CVRx announced compelling real-world evidence demonstrating significant healthcare utilization reductions with Barostim. Research presented at the Technology and Heart Failure Therapeutics (THT) conference and published simultaneously in the Journal of Cardiac Failure was conducted using data from the Premier Healthcare Database, a large all-payer database that includes information from more than 1,300 institutions. Comparisons were performed for the 306 Barostim patients identified in the data set for the 12 months prior to Barostim implant and for an average of almost two years post-implant. The analysis showed an
Business Outlook
For the full year of 2025, the Company now expects:
- Total revenue between
$55.0 million and$58.0 million ; - Gross margin between
83% and84% ; - Operating expenses between
$95.0 million and$98.0 million .
For the second quarter of 2025, the Company expects to report total revenue between
Webcast and Conference Call Information
The Company will host a conference call to review its results at 4:30 p.m. Eastern Time today. A live webcast of the investor conference call will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-800-445-7795 for U.S. callers, or 1-785-424-1699 for international callers, approximately ten minutes prior to the start time. Please reference the following conference ID to access the call: CVRXQ125.
About CVRx, Inc.
CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding our future financial performance (including our financial guidance regarding full year and second quarter 2025 results), our anticipated growth strategies, anticipated trends in our industry, our business prospects and our opportunities. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “outlook,” “guidance,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.
The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our history of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to continue demonstrating to physicians and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Investor Contact:
Mark Klausner or Mike Vallie
ICR Healthcare
443-213-0501
ir@cvrx.com
Media Contact:
Emily Meyers
CVRx, Inc.
763-416-2853
emeyers@cvrx.com
| CVRx, INC. Condensed Consolidated Balance Sheets (In thousands, except share and per share data) (Unaudited) | ||||||||
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 102,668 | $ | 105,933 | ||||
| Accounts receivable, net of allowances of | 9,012 | 9,268 | ||||||
| Inventory | 11,672 | 12,107 | ||||||
| Prepaid expenses and other current assets | 2,782 | 2,505 | ||||||
| Total current assets | 126,134 | 129,813 | ||||||
| Property and equipment, net | 2,435 | 2,505 | ||||||
| Operating lease right-of-use asset | 994 | 1,069 | ||||||
| Other non-current assets | 26 | 27 | ||||||
| Total assets | $ | 129,589 | $ | 133,414 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,751 | $ | 2,582 | ||||
| Accrued expenses | 5,757 | 8,180 | ||||||
| Total current liabilities | 8,508 | 10,762 | ||||||
| Long-term debt | 49,332 | 49,273 | ||||||
| Operating lease liability, non-current portion | 802 | 877 | ||||||
| Other long-term liabilities | 1,587 | 1,447 | ||||||
| Total liabilities | 60,229 | 62,359 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock, | 261 | 253 | ||||||
| Additional paid-in capital | 620,416 | 608,354 | ||||||
| Accumulated deficit | (551,112 | ) | (537,346 | ) | ||||
| Accumulated other comprehensive loss | (205 | ) | (206 | ) | ||||
| Total stockholders’ equity | 69,360 | 71,055 | ||||||
| Total liabilities and stockholders’ equity | $ | 129,589 | $ | 133,414 | ||||
| CVRx, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share data) (Unaudited) | ||||||||
| Three months ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenue | $ | 12,348 | $ | 10,770 | ||||
| Cost of goods sold | 2,036 | 1,615 | ||||||
| Gross profit | 10,312 | 9,155 | ||||||
| Operating expenses: | ||||||||
| Research and development | 2,517 | 3,057 | ||||||
| Selling, general and administrative | 21,232 | 28,330 | ||||||
| Total operating expenses | 23,749 | 31,387 | ||||||
| Loss from operations | (13,437 | ) | (22,232 | ) | ||||
| Interest expense | (1,457 | ) | (960 | ) | ||||
| Other income, net | 1,123 | 1,044 | ||||||
| Loss before income taxes | (13,771 | ) | (22,148 | ) | ||||
| Benefit (provision) for income taxes | 5 | (38 | ) | |||||
| Net loss | (13,766 | ) | (22,186 | ) | ||||
| Cumulative translation adjustment | — | (3 | ) | |||||
| Comprehensive loss | $ | (13,766 | ) | $ | (22,189 | ) | ||
| Net loss per share, basic and diluted | $ | (0.53 | ) | $ | (1.04 | ) | ||
| Weighted-average common shares used to compute net loss per share, basic and diluted | 25,876,062 | 21,232,009 | ||||||
FAQ
What were CVRx's (CVRX) Q1 2025 revenue and earnings?
How many active implanting centers does CVRx have in the US?
What is CVRx's revenue guidance for 2025?
How effective is CVRx's Barostim therapy according to real-world evidence?
What is CVRx's current cash position?
