CVRx Reports Third Quarter 2021 Financial and Operating Results
Recent Highlights
- Total revenue for the third quarter 2021 was
$3.4 million , an increase of 241% 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
Third Quarter 2021 Financial and Operating Results
| Revenue by Geography | |||||||||
| Three months ended September 30, | |||||||||
| 2021 | 2020 | ||||||||
| Amount | Amount | % Change | |||||||
| (dollars in thousands) | |||||||||
| $ | 2,572 | $ | 296 | 769 | % | ||||
| 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) | |||||||||
| $ | 2,468 | $ | 140 | NM | |||||
| 104 | 156 | (33) | % | ||||||
| Total |
$ | 2,572 | $ | 296 | 769 | % | |||
NM – Not meaningful
Revenue was
Revenue generated in the
As of
Revenue generated in
Gross profit was
R&D expenses increased
SG&A expenses increased
Other income, net was
Net loss was
As of
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% and 74.0%;
- 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
- 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
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
About
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
Investor Contact:
Westwicke, an
ir@cvrx.com
Media Contact:
978.750.0333 / 617.835.0396
lisa@trevicomm.com
CVRx, INC.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
| 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 | |||||||||||||||
| 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 | ||||||||||||
Source: CVRx, Inc.
