CVRx Reports Second Quarter 2024 Financial and Operating Results
Rhea-AI Summary
CVRx, Inc. (NASDAQ: CVRX) reported strong Q2 2024 financial results, with total revenue reaching $11.8 million, a 24% increase year-over-year. U.S. Heart Failure revenue grew 27% to $10.5 million. The company expanded its active implanting centers in the U.S. by 35% compared to Q2 2023. CVRx appointed new executives, including a Chief Revenue Officer, to strengthen its leadership team. Despite revenue growth, the company reported a net loss of $14.0 million, or $0.65 per share. CVRx updated its full-year 2024 guidance, projecting total revenue between $50.0 million and $53.0 million. The company remains focused on expanding therapy awareness, strengthening clinical evidence, and improving patient access for its Barostim technology.
Positive
- Total revenue increased 24% year-over-year to $11.8 million in Q2 2024
- U.S. Heart Failure revenue grew 27% to $10.5 million
- Active implanting centers in the U.S. increased by 35% compared to Q2 2023
- Gross profit increased 24% to $9.9 million with a stable gross margin of 84%
- Number of sales territories in the U.S. increased by three to a total of 42
- Strengthened executive team with key appointments to drive market development
Negative
- Net loss increased to $14.0 million in Q2 2024 from $11.6 million in Q2 2023
- SG&A expenses increased 28% to $21.1 million
- Revenue generated in Europe decreased by 6% to $1.1 million
- Cash and cash equivalents decreased to $70.4 million as of June 30, 2024
News Market Reaction 1 Alert
On the day this news was published, CVRX declined 14.51%, reflecting a significant negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
MINNEAPOLIS, July 29, 2024 (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 second quarter of 2024.
Recent Highlights
- Total revenue for the second quarter 2024 was
$11.8 million , an increase of24% over the prior year quarter - U.S. Heart Failure (HF) revenue for the second quarter of 2024 was
$10.5 million , an increase of27% over the prior year quarter - Active implanting centers in the U.S. were 189, an increase of
35% over the second quarter of 2023 - Hired new Chief Revenue Officer and completed expansion of executive leadership team
“We are pleased with our solid second quarter results, driven by another record quarter in our U.S. Heart Failure business. We remain extremely optimistic about the Barostim technology and our market opportunity. Our recent leadership appointments have significantly bolstered our executive team, positioning us well to address key market development priorities,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “Our focus is on continuing to broaden therapy awareness, strengthen our clinical evidence, and improve patient access. With our innovative technology, expanding market presence, and the depth of expertise on our expanded leadership team, we're well-positioned to drive Barostim towards becoming standard of care, making a meaningful difference in the lives of those suffering from heart failure and other cardiovascular diseases.”
Second Quarter 2024 Financial and Operating Results
Revenue was
Revenue generated in the U.S. was
As of June 30, 2024, the Company had a total of 189 active implanting centers, as compared to 190 as of March 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. increased by three to a total of 42 during the three months ended June 30, 2024.
Revenue generated in Europe was
Gross profit was
R&D expenses decreased
SG&A expenses increased
Other income, net increased
Net loss was
As of June 30, 2024, cash and cash equivalents were
Leadership Team Expansion
During the quarter, the Company strengthened its executive team to drive market development priorities. Key appointments include Robert John as Chief Revenue Officer, bringing over 25 years of sales leadership experience in the medical device industry; Dr. Philip Adamson as Chief Medical Officer; Bonnie Handke as SVP of Patient Access, Reimbursement, and Healthcare Economics; Jennifer Englund as SVP of Global Clinical Research to enhance clinical evidence; and Tonya Austin as Chief Human Resources Officer. These strategic hires position CVRx to effectively address awareness, clinical, and patient access barriers as it drives Barostim towards becoming standard of care for heart failure.
Business Outlook
For the full year of 2024, the Company now expects:
- Total revenue between
$50.0 million and$53.0 million ; - Gross margin between
83.0% and85.0% ; and - Operating expenses between
$95.0 million and$98.0 million , up from previously issued guidance of$92.0 million and$98.0 million
For the third quarter of 2024, 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 1-877-704-4453 for U.S. callers, or 1-201-389-0920 for international callers, approximately ten minutes prior to the start time.
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 third quarter 2024 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 demonstrate 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, 2023, 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 Westwicke
443-213-0501
ir@cvrx.com
Media Contact:
Laura O’Neill
Finn Partners
402-499-8203
laura.oneill@finnpartners.com
| CVRx, INC. Condensed Consolidated Balance Sheets (In thousands, except share and per share data) (Unaudited) | ||||||||
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 70,400 | $ | 90,569 | ||||
| Accounts receivable, net of allowances of | 8,606 | 7,551 | ||||||
| Inventory | 11,224 | 10,983 | ||||||
| Prepaid expenses and other current assets | 1,762 | 2,987 | ||||||
| Total current assets | 91,992 | 112,090 | ||||||
| Property and equipment, net | 2,763 | 1,763 | ||||||
| Operating lease right-of-use asset | 1,200 | 1,349 | ||||||
| Other non-current assets | 26 | 27 | ||||||
| Total assets | $ | 95,981 | $ | 115,229 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,516 | $ | 1,884 | ||||
| Accrued expenses | 5,610 | 5,980 | ||||||
| Total current liabilities | 9,126 | 7,864 | ||||||
| Long-term debt | 29,319 | 29,222 | ||||||
| Operating lease liability, non-current portion | 1,023 | 1,160 | ||||||
| Other long-term liabilities | 1,265 | 1,036 | ||||||
| Total liabilities | 40,733 | 39,282 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock, | 217 | 209 | ||||||
| Additional paid-in capital | 568,837 | 553,326 | ||||||
| Accumulated deficit | (513,596 | ) | (477,381 | ) | ||||
| Accumulated other comprehensive loss | (210 | ) | (207 | ) | ||||
| Total stockholders’ equity | 55,248 | 75,947 | ||||||
| Total liabilities and stockholders’ equity | $ | 95,981 | $ | 115,229 | ||||
| CVRx, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share data) (Unaudited) | ||||||||||||||||
| Three months ended | Six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue | $ | 11,807 | $ | 9,500 | $ | 22,577 | $ | 17,479 | ||||||||
| Cost of goods sold | 1,900 | 1,517 | 3,515 | 2,845 | ||||||||||||
| Gross profit | 9,907 | 7,983 | 19,062 | 14,634 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,765 | 3,280 | 5,822 | 6,696 | ||||||||||||
| Selling, general and administrative | 21,115 | 16,455 | 49,445 | 31,852 | ||||||||||||
| Total operating expenses | 23,880 | 19,735 | 55,267 | 38,548 | ||||||||||||
| Loss from operations | (13,973 | ) | (11,752 | ) | (36,205 | ) | (23,914 | ) | ||||||||
| Interest expense | (959 | ) | (481 | ) | (1,919 | ) | (721 | ) | ||||||||
| Other income, net | 944 | 616 | 1,988 | 1,678 | ||||||||||||
| Loss before income taxes | (13,988 | ) | (11,617 | ) | (36,136 | ) | (22,957 | ) | ||||||||
| Provision for income taxes | (41 | ) | (34 | ) | (79 | ) | (68 | ) | ||||||||
| Net loss | (14,029 | ) | (11,651 | ) | (36,215 | ) | (23,025 | ) | ||||||||
| Cumulative translation adjustment | — | 17 | (3 | ) | 20 | |||||||||||
| Comprehensive loss | $ | (14,029 | ) | $ | (11,634 | ) | $ | (36,218 | ) | $ | (23,005 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.65 | ) | $ | (0.56 | ) | $ | (1.69 | ) | $ | (1.11 | ) | ||||
| Weighted-average common shares used to compute net loss per share, basic and diluted | 21,628,542 | 20,711,850 | 21,430,276 | 20,702,589 | ||||||||||||
FAQ
What was CVRx's total revenue for Q2 2024?
How much did CVRx's U.S. Heart Failure revenue grow in Q2 2024?
What is CVRx's updated revenue guidance for full-year 2024?
How many active implanting centers did CVRx have in the U.S. as of Q2 2024?
What was CVRx's net loss per share for Q2 2024?
