CVRx Reports Third Quarter 2021 Financial and Operating Results
CVRx reported Q3 2021 revenue of $3.4 million, a notable 241% increase year-over-year. U.S. heart failure revenue surged to $2.5 million from $0.1 million in the prior year. The company successfully closed its IPO in July 2021, raising net proceeds of approximately $133.2 million, and has since fully repaid a $20 million loan. The outlook for 2021 remains positive, with projected revenue between $13.3 million and $13.9 million. Additionally, CVRx filed three PMA Supplement applications with the FDA to enhance its Barostim platform.
- Revenue of $3.4 million for Q3 2021, up 241% YoY.
- U.S. Heart Failure revenue increased to $2.5 million from $0.1 million.
- Successful IPO raised net proceeds of approximately $133.2 million.
- Fully repaid $20 million loan, improving cash position.
- Net loss of $6.1 million, compared to $3.2 million in Q3 2020.
- Gross margin decreased to 74% from 79% YoY.
Third Quarter 2021 Revenue of
MINNEAPOLIS, Nov. 04, 2021 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative and minimally invasive neuromodulation solutions for patients with cardiovascular diseases, today announced its financial and operating results for the third quarter of 2021.
Recent Highlights
- Total revenue for the third quarter 2021 was
$3.4 million , an increase of241% over prior year quarter - U.S. Heart Failure (HF) revenue for the third quarter of 2021 was
$2.5 million compared to$0.1 million in the prior year quarter - Closed Initial Public Offering (IPO) on July 2, 2021, raising net proceeds of approximately
$133.2 million - Filed three PMA Supplement applications related to the innovation of the Company’s product portfolio
- Fully repaid
$20 million loan subsequent to quarter end
“We are very encouraged by our performance in the quarter. Like other procedure-based companies, we experienced COVID-19 Delta variant related headwinds in the quarter, but were able to navigate through those challenges to deliver for our customers. We are particularly encouraged by the performance of our U.S. heart failure business, which continues to show strong early adoption trends,” said Nadim Yared, President and Chief Executive Officer of CVRx. “Looking ahead, we remain focused on the expansion of our U.S. commercial organization in an effort to drive wide-spread adoption. We will continue to engage with new customers, train surgeons, and onboard new active implanting facilities, in addition to supporting existing customers to grow their utilization of Barostim to bring relief to patients suffering from cardiovascular diseases.”
Third Quarter 2021 Financial and Operating Results
| Revenue by Geography | |||||||||
| Three months ended September 30, | |||||||||
| 2021 | 2020 | ||||||||
| Amount | Amount | % Change | |||||||
| (dollars in thousands) | |||||||||
| United States | $ | 2,572 | $ | 296 | 769 | % | |||
| Europe | 823 | 701 | 17 | % | |||||
| Total Revenue | $ | 3,395 | $ | 997 | 241 | % | |||
| United States Revenue by Product Category | |||||||||
| Three months ended September 30, | |||||||||
| 2021 | 2020 | ||||||||
| Amount | Amount | % Change | |||||||
| (dollars in thousands) | |||||||||
| U.S. Heart Failure (HF) | $ | 2,468 | $ | 140 | NM | ||||
| U.S. Legacy Hypertension | 104 | 156 | (33) | % | |||||
| Total U.S. Revenue | $ | 2,572 | $ | 296 | 769 | % | |||
NM – Not meaningful
Revenue was
Revenue generated in the U.S. was
As of September 30, 2021, the Company had a total of 38 active implanting centers, as compared to 31 as of June 30, 2021. 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 eleven during the three months ended September 30, 2021.
Revenue generated in Europe was
Gross profit was
R&D expenses increased
SG&A expenses increased
Other income, net was
Net loss was
As of September 30, 2021, cash and cash equivalents were
Business Outlook
For the full year of 2021, the Company continues to expect:
- Total revenue between
$13.3 million and$13.9 million ; - Gross margin between
72.0% and74.0% ; - Operating expenses between
$34.0 million and$36.0 million ;
For the fourth quarter of 2021, the Company expects to report total revenue between
Regulatory Update
In the last two months the Company filed three separate PMA Supplement submissions with the U.S. Food and Drug Administration (FDA), all of which relate to the development of its Barostim platform, for the following:
- MRI Conditional labeling, which would allow MRI scanning with specific instructions for patients implanted with Barostim
- New IPG, which would deliver
20% longer battery life on average and is smaller in volume relative to prior generations - New Programmer, which would provide even simpler programming software in a tablet form factor
Approval for the three PMA Supplement submissions is expected in the first half of 2022.
Debt Repayment
On November 3, 2021, the Company fully repaid its
Following the repayment, the Company believes it has more than three years of cash on hand to fund operations.
Webcast and Conference Call Information
The Company will host a conference call at 5:30 pm Eastern Time on November 4, 2021 to discuss results of the quarter as well as a question and answer session. To listen to the conference call on your telephone, please dial (833) 730-3980 for U.S. callers, or +1 (720) 405-2140 for international callers, approximately ten minutes prior to the start time and reference conference code 6038756. To listen to a live webcast, please visit the Investors section of the CVRx website at: ir.cvrx.com/news-events/events. The webcast replay will be available on the CVRx website for 12 months following completion of the call.
About CVRx, Inc.
CVRx is focused on the development and commercialization of Barostim™, 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. Baroreceptors activate the body’s baroreflex, which in turn triggers an autonomic response to the heart. 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 financial guidance regarding full year 2021 results and expectations about regulatory approvals, liquidity and cash resources and adoption of our Barostim therapy. 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 NEO; our ability to establish and maintain sales and marketing capabilities; our ability to demonstrate to physicians and patients the merits of our BAROSTIM NEO; any failure by third-party payors to provide adequate coverage and reimbursement for the use of BAROSTIM NEO; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier to use or otherwise more attractive than BAROSTIM NEO; 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, including the outbreak of the novel strain of coronavirus, COVID-19; any failure of clinical studies for future indications to produce results necessary to support regulatory clearance or approval in the U.S. or elsewhere; 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; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part II, Item 1A. Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, 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
Westwicke, an ICR Company
ir@cvrx.com
Media Contact:
Lisa Murray
Trevi Communications, Inc.
978.750.0333 / 617.835.0396
lisa@trevicomm.com
CVRx, INC.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 170,913 | $ | 59,112 | ||||
| Accounts receivable, net | 3,421 | 1,281 | ||||||
| Inventory | 3,440 | 3,343 | ||||||
| Prepaid expenses and other current assets | 2,923 | 605 | ||||||
| Total current assets | 180,697 | 64,341 | ||||||
| Property and equipment, net | 943 | 410 | ||||||
| Other non-current assets | 67 | 26 | ||||||
| Total assets | $ | 181,707 | $ | 64,777 | ||||
| Liabilities and Stockholders’ Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 541 | $ | 483 | ||||
| Accrued expenses | 4,977 | 3,583 | ||||||
| Warrant liability | — | 3,911 | ||||||
| Current portion of long-term debt | 3,333 | — | ||||||
| Total current liabilities | 8,851 | 7,977 | ||||||
| Long-term debt | 16,151 | 19,278 | ||||||
| Other long-term liabilities | 941 | 777 | ||||||
| Total liabilities | 25,943 | 28,032 | ||||||
| Commitments and contingencies | ||||||||
| Convertible preferred stock, | — | 329,983 | ||||||
| Stockholders’ equity (deficit): | ||||||||
| Common stock, | 204 | 4 | ||||||
| Additional paid-in capital | 539,941 | 58,624 | ||||||
| Accumulated deficit | (384,184 | ) | (351,676 | ) | ||||
| Accumulated other comprehensive loss | (197 | ) | (190 | ) | ||||
| Total stockholders’ equity (deficit) | 155,764 | (293,238 | ) | |||||
| Total liabilities, convertible preferred stock, and stockholders’ equity | $ | 181,707 | $ | 64,777 | ||||
CVRx, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)
| Three months ended | Nine months ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue | $ | 3,395 | $ | 997 | $ | 9,378 | $ | 3,965 | ||||||||
| Cost of goods sold | 876 | 212 | 2,656 | 989 | ||||||||||||
| Gross profit | 2,519 | 785 | 6,722 | 2,976 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,699 | 1,500 | 5,704 | 5,900 | ||||||||||||
| Selling, general and administrative | 8,111 | 2,327 | 18,198 | 6,455 | ||||||||||||
| Total operating expenses | 9,810 | 3,827 | 23,902 | 12,355 | ||||||||||||
| Loss from operations | (7,291 | ) | (3,042 | ) | (17,180 | ) | (9,379 | ) | ||||||||
| Interest expense | (614 | ) | (621 | ) | (1,823 | ) | (1,856 | ) | ||||||||
| Other income (expense), net | 1,795 | 455 | (13,439 | ) | 592 | |||||||||||
| Loss before income taxes | (6,110 | ) | (3,208 | ) | (32,442 | ) | (10,643 | ) | ||||||||
| Provision for income taxes | (23 | ) | (19 | ) | (66 | ) | (64 | ) | ||||||||
| Net loss | (6,133 | ) | (3,227 | ) | (32,508 | ) | (10,707 | ) | ||||||||
| Cumulative translation adjustment | (3 | ) | 14 | (8 | ) | (7 | ) | |||||||||
| Comprehensive loss | $ | (6,136 | ) | $ | (3,213 | ) | $ | (32,516 | ) | $ | (10,714 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.30 | ) | $ | (9.56 | ) | $ | (4.66 | ) | $ | (27.58 | ) | ||||
| Weighted-average common shares used to compute net loss per share, basic and diluted | 20,126,672 | 360,356 | 6,975,386 | 396,071 | ||||||||||||
FAQ
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