CVRx Reports Fourth Quarter and Full Year 2021 Financial and Operating Results
Recent Highlights
- Total revenue for the fourth quarter of 2021 was
$3.7 million , an increase of 75% over the prior year quarter U.S. Heart Failure (HF) revenue for the fourth quarter of 2021 was$2.7 million , an increase of 345% over the prior year quarter- Total revenue for 2021 was
$13.0 million , an increase of 115% over the prior year - Received FDA Implantable Pulse Generator (“IPG”) approval in
December 2021 - Fully repaid
$20 million loan onNovember 3, 2021
“We are very proud of everything we accomplished in 2021 despite the challenging global environment. We more than doubled our revenue as a result of the successful launch of Barostim for heart failure in
Fourth Quarter 2021 Financial and Operating Results
| Revenue by Product Category/Geography | ||||||||||||
| Three months ended December 31, | ||||||||||||
| 2021 | 2020 | |||||||||||
| Amount | Amount | % Change | ||||||||||
| (dollars in thousands) | ||||||||||||
| $ | 2,702 | $ | 607 | 345 | % | |||||||
| $ | 156 | $ | 224 | (30 | ) | % | ||||||
| $ | 2,858 | $ | 831 | 244 | % | |||||||
| $ | 800 | $ | 1,257 | (36 | ) | % | ||||||
| Total Revenue | $ | 3,658 | $ | 2,088 | 75 | % | ||||||
Revenue was
Revenue generated in the
As of
Revenue generated in
Gross profit was
R&D expenses increased
SG&A expenses increased
Other expense, net was
Net loss was
Full Year 2021 Financial and Operating Results
| Revenue by Product Category/Geography | ||||||||||||
| Full year ended December 31, | ||||||||||||
| 2021 | 2020 | |||||||||||
| Amount | Amount | % Change | ||||||||||
| (dollars in thousands) | ||||||||||||
| $ | 8,429 | $ | 987 | 754 | % | |||||||
| $ | 718 | $ | 746 | (4 | ) | % | ||||||
| $ | 9,147 | $ | 1,733 | 428 | % | |||||||
| $ | 3,889 | $ | 4,320 | (10 | ) | % | ||||||
| Total Revenue | $ | 13,036 | $ | 6,053 | 115 | % | ||||||
Revenue was
Revenue generated in the
As of
Revenue generated in
Gross profit was
R&D expenses increased
SG&A expenses increased
Other expense, net was
Net loss was
As of
Business Outlook
For the full year of 2022, the Company expects:
- Total revenue between
$20.0 million and$23.0 million ; - Gross margin between 74.0% and 76.0%;
- Operating expenses between
$55.0 million and$61.0 million .
For the first quarter of 2022, the Company expects to report total revenue between
Regulatory Update
In 2021, 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 when compared to the current IPG
- New Programmer, which would provide even simpler programming software in a tablet form factor
The company received FDA approval for the new IPG in December of 2021. Approval for the two additional PMA Supplement submissions is expected in the first half of 2022.
Debt Repayment
On
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 2022 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; our ability to establish and maintain sales and marketing capabilities; our ability to demonstrate to physicians and patients the merits of 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
Investor Contact:
ICR Westwicke
443-213-0501
ir@cvrx.com
Media Contact:
978.750.0333 / 617.835.0396
lisa@trevicomm.com
CVRx, INC.
Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 142,072 | $ | 59,112 | ||||
| Accounts receivable, net | 2,560 | 1,281 | ||||||
| Inventory | 3,880 | 3,343 | ||||||
| Prepaid expenses and other current assets | 2,585 | 605 | ||||||
| Total current assets | 151,097 | 64,341 | ||||||
| Property and equipment, net | 1,425 | 410 | ||||||
| Other non-current assets | 26 | 26 | ||||||
| Total assets | $ | 152,548 | $ | 64,777 | ||||
| Liabilities and Stockholders’ Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 510 | $ | 483 | ||||
| Accrued expenses | 5,398 | 3,583 | ||||||
| Warrant liability | — | 3,911 | ||||||
| Total current liabilities | 5,908 | 7,977 | ||||||
| Long-term debt | — | 19,278 | ||||||
| Other long-term liabilities | 681 | 777 | ||||||
| Total liabilities | 6,589 | 28,032 | ||||||
| Commitments and contingencies | ||||||||
| Convertible preferred stock, |
— | 329,983 | ||||||
| Stockholders’ equity (deficit): | ||||||||
| Common stock, |
204 | 4 | ||||||
| Additional paid-in capital | 540,707 | 58,624 | ||||||
| Accumulated deficit | (394,754 | ) | (351,676 | ) | ||||
| Accumulated other comprehensive loss | (198 | ) | (190 | ) | ||||
| Total stockholders’ equity (deficit) | 145,959 | (293,238 | ) | |||||
| Total liabilities, convertible preferred stock, and stockholders’ equity (deficit) | $ | 152,548 | $ | 64,777 | ||||
CVRx, INC.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)
| Three months ended | Year ended | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue | $ | 3,658 | $ | 2,088 | $ | 13,036 | $ | 6,053 | ||||||||
| Cost of goods sold | 984 | 451 | 3,640 | 1,440 | ||||||||||||
| Gross profit | 2,674 | 1,637 | 9,396 | 4,613 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,797 | 510 | 7,501 | 6,410 | ||||||||||||
| Selling, general and administrative | 9,665 | 3,262 | 27,863 | 9,717 | ||||||||||||
| Total operating expenses | 11,462 | 3,772 | 35,364 | 16,127 | ||||||||||||
| Loss from operations | (8,788 | ) | (2,135 | ) | (25,968 | ) | (11,514 | ) | ||||||||
| Interest expense | (396 | ) | (614 | ) | (2,219 | ) | (2,470 | ) | ||||||||
| Other expense, net | (1,361 | ) | (632 | ) | (14,800 | ) | (40 | ) | ||||||||
| Loss before income taxes | (10,545 | ) | (3,381 | ) | (42,987 | ) | (14,024 | ) | ||||||||
| Provision for income taxes | (25 | ) | (21 | ) | (91 | ) | (85 | ) | ||||||||
| Net loss | (10,570 | ) | (3,402 | ) | (43,078 | ) | (14,109 | ) | ||||||||
| Cumulative translation adjustment | — | 6 | (8 | ) | (1 | ) | ||||||||||
| Comprehensive loss | $ | (10,570 | ) | $ | (3,396 | ) | $ | (43,086 | ) | $ | (14,110 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.52 | ) | $ | (10.04 | ) | $ | (4.16 | ) | $ | (37.01 | ) | ||||
| Weighted-average common shares used to compute net loss per share, basic and diluted | 20,367,064 | 360,412 | 10,360,054 | 387,083 | ||||||||||||
Source: CVRx, Inc.
