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 2024.
Recent Highlights
- Total revenue for the first quarter
2024 was $10.8 million, an increase of 35% over the prior year
quarter
- U.S. Heart Failure (HF) revenue for
the first quarter of 2024 was $9.7 million, an increase of 43% over
the prior year quarter
- Active implanting centers in the
U.S. grew to 190, an increase of 56% over the first quarter of
2023
- Kevin Hykes was appointed as Chief
Executive Officer on February 12, 2024
- BeAT-HF post-market data was
published in the European Journal of Heart Failure in April
2024
“We had a solid first quarter, which was offset by some
commercial execution challenges in our U.S. Heart Failure business
during our recent management transition in February. We are taking
steps to address these challenges, including a change in sales
leadership, which we are announcing today. I’ve also begun the
process of broadening our leadership team and intensifying our
efforts on therapy awareness, clinical evidence, and patient
access, which will be important in order to scale the business to
address the tremendous opportunity in front of us,” said Kevin
Hykes, President and Chief Executive Officer of CVRx. “In my first
two months, I have seen first-hand that Barostim is a highly
impactful therapy, which has been proven to significantly improve
the lives of patients suffering from heart failure. Based on my
prior industry experience, I appreciate the remarkable opportunity
that Barostim represents and am convinced that we can successfully
advance this therapy towards standard of care.”
First Quarter 2024 Financial and Operating
Results
Revenue was $10.8 million for the three months ended March 31,
2024, an increase of $2.8 million, or 35%, over the three months
ended March 31, 2023.
Revenue generated in the U.S. was $9.8 million for the three
months ended March 31, 2024, an increase of $2.9 million, or 42%,
over the three months ended March 31, 2023. HF revenue units in the
U.S. totaled 319 and 225 for the three months ended March 31, 2024
and 2023, respectively. HF revenue in the U.S. totaled $9.7 million
and $6.8 million for the three months ended March 31, 2024 and
2023, 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, 2024, the Company had a total of 190 active
implanting centers, as compared to 178 as of December 31, 2023.
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 one to a total of 39
during the three months ended March 31, 2024.
Revenue generated in Europe was $0.9 million for the three
months ended March 31, 2024, an increase of $0.1 million, or 10%,
over the three months ended March 31, 2023. Total revenue units in
Europe decreased to 44 for the three months ended March 31, 2024
from 52 in the prior year period. The number of sales territories
in Europe remained consistent at six for the three months ended
March 31, 2024.
Gross profit was $9.2 million for the three months ended March
31, 2024, an increase of $2.5 million, or 38%, over the three
months ended March 31, 2023. Gross margin increased to 85% for the
three months ended March 31, 2024. compared to 83% for the three
months ended March 31, 2023. This increase was due primarily to a
decrease in the cost per unit driven by an increase in the
production volume.
R&D expenses decreased $0.4 million, or 11%, to $3.1 million
for the three months ended March 31, 2024 compared to the three
months ended March 31, 2023. This change was driven by a $0.2
million decrease in non-cash stock-based compensation expense, and
a $0.2 million decrease in consulting expenses.
SG&A expenses increased $12.9 million, or 84%, to $28.3
million for the three months ended March 31, 2024 compared to the
three months ended March 31, 2023. This change was primarily driven
by a $9.6 million increase in non-cash stock-based compensation
expense, a $2.0 million increase in compensation expense and a $0.6
million increase in travel expenses. Approximately $8.4 million of
the increase in non-cash stock-based compensation expense is
related to the previously disclosed modification of stock options
held by the former CEO in connection with his retirement in the
first quarter of 2024.
Other income, net decreased $18,000 for the three months ended
March 31, 2024, compared to the three months ended March 31, 2023.
This decrease was primarily driven a lower cash balance in our
interest-bearing accounts.
Net loss was $22.2 million, or $1.04 per share, for the three
months ended March 31, 2024, compared to a net loss of $11.4
million, or $0.55 per share, for the three months ended March 31,
2023. Net loss per share was based on 21.2 million weighted average
shares outstanding for three months ended March 31, 2024 and 20.7
million weighted average shares outstanding for the three months
ended March 31, 2023.
As of March 31, 2024, cash and cash equivalents were $80.1
million. Net cash used in operating and investing activities was
$11.8 million for the quarter ended March 31, 2024. This is
compared to net cash used in operating and investing activities of
$8.0 million for the three months ended December 31, 2023.
Business Outlook
For the full year of 2024, the Company now expects:
- Total revenue
between $50.0 million and $53.0 million;
- Gross margin
between 83.0% and 85.0%; and
- Operating expenses
between $92.0 million and $98.0 million.
For the second quarter of 2024, the Company expects to report
total revenue between $11.3 million and $12.3 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. 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 our financial guidance
regarding full year and second quarter 2024 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 limited
commercial sales experience marketing and selling Barostim; 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 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; 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; impacts on
adoption and regulatory approvals resulting from additional
long-term clinical data about our product; 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, 2023, 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, |
|
|
2024 |
|
|
2023 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
80,115 |
|
|
$ |
90,569 |
|
Accounts receivable, net of allowances of $647 and $508,
respectively |
|
|
8,495 |
|
|
|
7,551 |
|
Inventory |
|
|
11,056 |
|
|
|
10,983 |
|
Prepaid expenses and other current assets |
|
|
2,656 |
|
|
|
2,987 |
|
Total current assets |
|
|
102,322 |
|
|
|
112,090 |
|
Property and equipment, net |
|
|
2,549 |
|
|
|
1,763 |
|
Operating lease right-of-use
asset |
|
|
1,274 |
|
|
|
1,349 |
|
Other non-current assets |
|
|
26 |
|
|
|
27 |
|
Total assets |
|
$ |
106,171 |
|
|
$ |
115,229 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,608 |
|
|
$ |
1,884 |
|
Accrued expenses |
|
|
5,790 |
|
|
|
5,980 |
|
Total current liabilities |
|
|
8,398 |
|
|
|
7,864 |
|
Long-term debt |
|
|
29,270 |
|
|
|
29,222 |
|
Operating lease liability,
non-current portion |
|
|
1,092 |
|
|
|
1,160 |
|
Other long-term liabilities |
|
|
1,150 |
|
|
|
1,036 |
|
Total liabilities |
|
|
39,910 |
|
|
|
39,282 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, $0.01 par value,
200,000,000 authorized as of March 31, 2024 and
December 31, 2023; 21,593,173 and 20,879,199 shares
issued and outstanding as of March 31, 2024 and
December 31, 2023, respectively |
|
|
216 |
|
|
|
209 |
|
Additional paid-in capital |
|
|
565,822 |
|
|
|
553,326 |
|
Accumulated deficit |
|
|
(499,567 |
) |
|
|
(477,381 |
) |
Accumulated other comprehensive
loss |
|
|
(210 |
) |
|
|
(207 |
) |
Total stockholders’ equity |
|
|
66,261 |
|
|
|
75,947 |
|
Total liabilities and stockholders’ equity |
|
$ |
106,171 |
|
|
$ |
115,229 |
|
CVRx, INC.Condensed Consolidated
Statements of Operations and Comprehensive Loss(In
thousands, except share and per share
data)(Unaudited) |
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
March 31, |
|
|
2024 |
|
|
2023 |
|
Revenue |
|
$ |
10,770 |
|
|
$ |
7,979 |
|
Cost of goods sold |
|
|
1,615 |
|
|
|
1,328 |
|
Gross profit |
|
|
9,155 |
|
|
|
6,651 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
3,057 |
|
|
|
3,416 |
|
Selling, general and administrative |
|
|
28,330 |
|
|
|
15,397 |
|
Total operating expenses |
|
|
31,387 |
|
|
|
18,813 |
|
Loss from operations |
|
|
(22,232 |
) |
|
|
(12,162 |
) |
Interest expense |
|
|
(960 |
) |
|
|
(240 |
) |
Other income, net |
|
|
1,044 |
|
|
|
1,062 |
|
Loss before income taxes |
|
|
(22,148 |
) |
|
|
(11,340 |
) |
Provision for income taxes |
|
|
(38 |
) |
|
|
(34 |
) |
Net loss |
|
|
(22,186 |
) |
|
|
(11,374 |
) |
Cumulative translation
adjustment |
|
|
(3 |
) |
|
|
3 |
|
Comprehensive loss |
|
$ |
(22,189 |
) |
|
$ |
(11,371 |
) |
Net loss per share, basic and
diluted |
|
$ |
(1.04 |
) |
|
$ |
(0.55 |
) |
Weighted-average common shares
used to compute net loss per share, basic and diluted |
|
|
21,232,009 |
|
|
|
20,693,224 |
|
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