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 first quarter of 2023.
Recent Highlights
- Totality of evidence from BeAT-HF
post-market study shows long-term benefits for patients with heart
failure
- U.S. Heart Failure (HF) revenue for
the first quarter of 2023 was $6.8 million compared to $2.9 million
in the prior year quarter, an increase of 132% over prior year
quarter
- Active implanting centers in the
U.S. grew to 122, an increase of 118% over the first quarter of
2022
- Worldwide revenue for the first
quarter of 2023 was $8.0 million, an increase of 96% over prior
year quarter
“I am thrilled with our first quarter performance, which
demonstrated solid execution on multiple fronts. We were able to
share the preliminary data from BeAT-HF during the first quarter
and grow our US heart failure business. This is a testament to our
team’s ability to accelerate adoption of Barostim through the
increased capabilities of our commercial organization and our
marketing and awareness efforts,” said Nadim Yared, President and
Chief Executive Officer of CVRx. “As we look ahead to the rest of
2023, we are excited about the opportunities that lie ahead and
confident that we will bring relief to patients suffering from
heart failure.”
First Quarter 2023 Financial and Operating
Results
Revenue was $8.0 million for the three months ended March 31,
2023, an increase of $3.9 million, or 96%, over the three months
ended March 31, 2022.
Revenue generated in the U.S. was $6.9 million for the three
months ended March 31, 2023, an increase of $3.9 million, or 127%,
over the three months ended March 31, 2022. HF revenue units in the
U.S. totaled 225 and 99 for the three months ended March 31, 2023
and 2022, respectively. HF revenue in the U.S. totaled $6.8 million
and $2.9 million for the three months ended March 31, 2023 and
2022, respectively. The increases were primarily driven by
continued growth in the U.S. HF business as a result of the
expansion into new sales territories, new accounts and increased
physician and patient awareness of Barostim.
As of March 31, 2023, the Company had a total of 122 active
implanting centers, as compared to 106 as of December 31, 2022.
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
29 during the three months ended March 31, 2023.
Revenue generated in Europe was $1.0 million for the three
months ended March 31, 2023, an increase of $0.02 million, or 2%,
over the three months ended March 31, 2022. Total revenue units in
Europe increased to 52 for the three months ended March 31, 2023
from 50 in the prior year period. The number of sales territories
in Europe remained consistent at six for the three months ended
March 31, 2023.
Gross profit was $6.7 million for the three months ended March
31, 2023, an increase of $3.5 million, or 113%, over the three
months ended March 31, 2022. Gross margin increased to 83% for the
three months ended March 31, 2023 compared to 77% for the three
months ended March 31, 2022. Gross margin for the three months
ended March 31, 2023 improved due primarily to a decrease in the
cost per unit driven by an increase in the production volume.
R&D expenses increased $1.2 million, or 51%, to $3.4 million
for the three months ended March 31, 2023 compared to the three
months ended March 31, 2022. This change was driven by a $0.5
million increase in compensation expenses as a result of increased
headcount, a $0.4 million increase in non-cash stock-based
compensation expense and a $0.4 million increase in consulting
fees.
SG&A expenses increased $4.6 million, or 43%, to $15.4
million for the three months ended March 31, 2023 compared to the
three months ended March 31, 2022. This change was primarily driven
by a $2.6 million increase in compensation expenses, mainly as a
result of increased headcount, a $0.8 million increase in travel
expenses, a $0.6 million increase in marketing and advertising
expenses associated with the commercialization of Barostim in the
U.S., and a $0.5 million increase in non-cash stock-based
compensation expense.
Other income, net was $1.1 million for the three months ended
March 31, 2023 compared to other expense, net of $57,000 for the
three months ended March 31, 2022. The income in the first quarter
of 2023 was primarily driven by interest income on our
interest-bearing account.
Net loss was $11.4 million, or $0.55 per share, for the three
months ended March 31, 2023, compared to a net loss of $10.0
million, or $0.49 per share, for the three months ended March 31,
2022. Net loss per share was based on 20,693,224 weighted average
shares outstanding for the first quarter of 2023 and 20,453,341
weighted average shares outstanding for the first quarter of
2022.
As of March 31, 2023, cash and cash equivalents were $103.3
million. Net cash used in operating and investing activities was
$10.5 million for the quarter ended March 31, 2023, compared to
$10.9 million for the quarter ended March 31, 2022.
Business Outlook
For the full year of 2023, the Company expects:
- Total revenue
between $35.5 million and $38.0 million, compared to prior guidance
of between $35.0 million and $38.0 million;
- Gross margin
between 80.0% and 83.0%, compared to prior guidance of between 78%
and 79%;
- Operating expenses
between $76.0 million and $80.0 million.
For the second quarter of 2023, the Company expects to report
total revenue between $8.2 million and $8.8 million.
Webcast and Conference Call Information
The Company will host a conference call to review its results at
5:00 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. 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
future financial performance (including, specifically, our
2023 expected operating and financial 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 ability to
establish and maintain sales and marketing capabilities; 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, 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 I, Item 1A. Risk
Factors” in our Annual Report on Form 10-K for the year ended
December 31, 2022, 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
VallieICR Westwicke443-213-0501ir@cvrx.com
Media Contact:Laura O’NeillFinn
Partners402-499-8203laura.oneill@finnpartners.com
CVRx, INC.Condensed
Consolidated Balance Sheets(In thousands, except
share and per share data)(Unaudited)
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2023 |
|
2022 |
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
103,276 |
|
|
$ |
106,194 |
|
Accounts receivable, net of allowances of $641 and $679,
respectively |
|
|
6,434 |
|
|
|
5,504 |
|
Inventory |
|
|
8,241 |
|
|
|
6,957 |
|
Prepaid expenses and other current assets |
|
|
2,631 |
|
|
|
4,223 |
|
Total current assets |
|
|
120,582 |
|
|
|
122,878 |
|
Property
and equipment, net |
|
|
1,805 |
|
|
|
1,698 |
|
Operating lease right-of-use asset |
|
|
277 |
|
|
|
334 |
|
Other
non-current assets |
|
|
27 |
|
|
|
27 |
|
Total assets |
|
$ |
122,691 |
|
|
$ |
124,937 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,996 |
|
|
$ |
1,719 |
|
Accrued expenses |
|
|
5,961 |
|
|
|
6,369 |
|
Total current liabilities |
|
|
7,957 |
|
|
|
8,088 |
|
Long-term debt |
|
|
14,218 |
|
|
|
6,747 |
|
Operating lease liability, non-current portion |
|
|
59 |
|
|
|
117 |
|
Other
long-term liabilities |
|
|
815 |
|
|
|
805 |
|
Total liabilities |
|
|
23,049 |
|
|
|
15,757 |
|
Commitments and contingencies |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, $0.01 par value,
200,000,000 authorized as of March 31, 2023 and
December 31, 2022; 20,708,940 and 20,633,736 shares
issued and outstanding as of March 31, 2023 and
December 31, 2022, respectively |
|
|
207 |
|
|
|
207 |
|
Additional paid-in capital |
|
|
547,195 |
|
|
|
545,362 |
|
Accumulated deficit |
|
|
(447,556 |
) |
|
|
(436,182 |
) |
Accumulated other comprehensive loss |
|
|
(204 |
) |
|
|
(207 |
) |
Total stockholders’ equity |
|
|
99,642 |
|
|
|
109,180 |
|
Total liabilities and stockholders’ equity |
|
$ |
122,691 |
|
|
$ |
124,937 |
|
CVRx, INC.Condensed
Consolidated Statements of Operations and Comprehensive
Loss(In thousands, except share and per share
data)(Unaudited)
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
March 31, |
|
|
2023 |
|
2022 |
Revenue |
|
$ |
7,979 |
|
|
$ |
4,076 |
|
Cost of
goods sold |
|
|
1,328 |
|
|
|
949 |
|
Gross profit |
|
|
6,651 |
|
|
|
3,127 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
3,416 |
|
|
|
2,258 |
|
Selling, general and administrative |
|
|
15,397 |
|
|
|
10,777 |
|
Total operating expenses |
|
|
18,813 |
|
|
|
13,035 |
|
Loss from operations |
|
|
(12,162 |
) |
|
|
(9,908 |
) |
Interest
expense |
|
|
(240 |
) |
|
|
— |
|
Other
income (expense), net |
|
|
1,062 |
|
|
|
(57 |
) |
Loss before income taxes |
|
|
(11,340 |
) |
|
|
(9,965 |
) |
Provision for income taxes |
|
|
(34 |
) |
|
|
(26 |
) |
Net loss |
|
|
(11,374 |
) |
|
|
(9,991 |
) |
Cumulative translation adjustment |
|
|
3 |
|
|
|
(6 |
) |
Comprehensive loss |
|
$ |
(11,371 |
) |
|
$ |
(9,997 |
) |
Net loss
per share, basic and diluted |
|
$ |
(0.55 |
) |
|
$ |
(0.49 |
) |
Weighted-average common shares used to compute net loss per share,
basic and diluted |
|
|
20,693,224 |
|
|
|
20,453,341 |
|
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