CVRx Reports Second Quarter 2021 Financial and Operating Results
Recent Highlights
- Total revenue for the second quarter 2021 was
$3.1 million , an increase of 150% over prior year quarter U.S. Heart Failure (HF) revenue for the second quarter of 2021 was$2.0 million compared to$0.07 million in the prior year quarter- Closed Initial Public Offering (IPO) on
July 2, 2021 , raising net proceeds of approximately$133.3 million Martha Shadan appointed to the Company’s Board of Directors- Successfully completed the first clinical procedure with BATwire, a new ultrasound-guided implant toolkit
“We are extremely pleased with our continued strong financial and operational performance during the quarter. We delivered topline growth of 150%, driven by a significant increase in the number of active implanting centers added in recent quarters, as well as the accelerated utilization of Barostim by existing customers. These results demonstrate the strong and growing adoption of Barostim by physicians and patients as a solution for heart failure,” said
Second Quarter 2021 Financial and Operating Results
| Revenue by Geography | ||||||||||
| Three months ended June 30, | ||||||||||
| 2021 | 2020 | |||||||||
| Amount | Amount | % Change | ||||||||
| (dollars in thousands) | ||||||||||
| $ | 2,105 | $ | 197 | 969 | % | |||||
| 1,018 | 1,053 | (3 | ) | % | ||||||
| Total Revenue | $ | 3,123 | $ | 1,250 | 150 | % | ||||
| United States Revenue by Product Category | ||||||||||
| Three months ended June 30, | ||||||||||
| 2021 | 2020 | |||||||||
| Amount | Amount | % Change | ||||||||
| (dollars in thousands) | ||||||||||
| $ | 2,001 | $ | 65 | NM | ||||||
| 104 | 132 | (21 | ) | % | ||||||
| Total |
$ | 2,105 | $ | 197 | 969 | % | ||||
NM – Not meaningful
Revenue increased by
Revenue generated in the
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 2021, the Company expects:
- 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 third quarter of 2021, the Company expects to report total revenue between
Initial Public Stock Offering
On
In connection with the IPO, on
The table below presents the Company’s balance sheet data as of
- the conversion of all outstanding shares of our convertible preferred stock into an aggregate of 11,929,584 shares of common stock upon the closing of the IPO; and
- the sale of 8,050,000 shares of common stock in the IPO, after deducting the underwriting discount and estimated offering expenses.
| As of |
|||||||
| Actual | Pro forma as adjusted |
||||||
| (in thousands, except share data) | |||||||
| Cash and cash equivalents | $ | 47,128 | $ | 180,385 | |||
| Convertible preferred stock warrant liability | 19,051 | - | |||||
| Redeemable convertible preferred stock | 329,983 | - | |||||
| Total stockholders’ equity (deficit) | $ | (318,931 | ) | $ | 163,360 | ||
| Shares of common stock outstanding | 366,342 | 20,345,926 | |||||
Board of Directors Appointment
On
First Clinical Procedure with BATwire
In
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 third quarter and full year 2021 results and expectations about 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 | $ | 47,128 | $ | 59,112 | ||||
| Accounts receivable, net | 2,243 | 1,281 | ||||||
| Inventory | 3,161 | 3,343 | ||||||
| Prepaid expenses and other current assets | 1,684 | 605 | ||||||
| Total current assets | 54,216 | 64,341 | ||||||
| Property and equipment, net | 820 | 410 | ||||||
| Other non-current assets | 26 | 26 | ||||||
| Total assets | $ | 55,062 | $ | 64,777 | ||||
| Liabilities and Stockholders’ Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 888 | $ | 483 | ||||
| Accrued expenses | 3,772 | 3,583 | ||||||
| Warrant liability | 19,051 | 3,911 | ||||||
| Current portion of long-term debt | 1,333 | — | ||||||
| Total current liabilities | 25,044 | 7,977 | ||||||
| Long-term debt | 18,082 | 19,278 | ||||||
| Other long-term liabilities | 884 | 777 | ||||||
| Total liabilities | 44,010 | 28,032 | ||||||
| Commitments and contingencies | ||||||||
| Convertible preferred stock, outstanding as of |
329,983 | 329,983 | ||||||
| Stockholders’ equity (deficit): | ||||||||
| Common stock, |
4 | 4 | ||||||
| Additional paid-in capital, common stock | 59,311 | 58,624 | ||||||
| Accumulated deficit | (378,051 | ) | (351,676 | ) | ||||
| Accumulated other comprehensive loss | (195 | ) | (190 | ) | ||||
| Total stockholders’ equity (deficit) | (318,931 | ) | (293,238 | ) | ||||
| Total liabilities, convertible preferred stock, and stockholders’ equity (deficit) | $ | 55,062 | $ | 64,777 | ||||
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 | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue | $ | 3,123 | $ | 1,250 | $ | 5,983 | $ | 2,968 | ||||||||
| Cost of goods sold | 913 | 345 | 1,780 | 777 | ||||||||||||
| Gross profit | 2,210 | 905 | 4,203 | 2,191 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,255 | 2,131 | 4,005 | 4,400 | ||||||||||||
| Selling, general and administrative | 5,627 | 1,834 | 10,087 | 4,128 | ||||||||||||
| Total operating expenses | 7,882 | 3,965 | 14,092 | 8,528 | ||||||||||||
| Loss from operations | (5,672 | ) | (3,060 | ) | (9,889 | ) | (6,337 | ) | ||||||||
| Interest expense | (608 | ) | (618 | ) | (1,209 | ) | (1,235 | ) | ||||||||
| Other income (expense), net | (11,442 | ) | 33 | (15,234 | ) | 137 | ||||||||||
| Loss before income taxes | (17,722 | ) | (3,645 | ) | (26,332 | ) | (7,435 | ) | ||||||||
| Provision for income taxes | (26 | ) | (22 | ) | (43 | ) | (45 | ) | ||||||||
| Net loss | (17,748 | ) | (3,667 | ) | (26,375 | ) | (7,480 | ) | ||||||||
| Cumulative translation adjustment | (1 | ) | (11 | ) | (5 | ) | (21 | ) | ||||||||
| Comprehensive loss | $ | (17,749 | ) | $ | (3,678 | ) | $ | (26,380 | ) | $ | (7,501 | ) | ||||
| Net loss per share, basic and diluted | $ | (48.48 | ) | $ | (10.18 | ) | $ | (72.58 | ) | $ | (18.06 | ) | ||||
| Weighted-average common shares used to compute net loss per share, basic and diluted |
366,066 | 360,238 | 363,397 | 414,225 | ||||||||||||
Source: CVRx, Inc.
