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 second quarter of 2023.
Recent Highlights
- Total revenue for the second
quarter of 2023 was $9.5 million, an increase of 89% over prior
year quarter
- U.S. Heart Failure (HF) revenue for
the second quarter of 2023 was $8.3 million compared to $3.8 in the
prior year quarter, an increase of 119% over the prior year
quarter
- Active implanting centers in the
U.S. grew to 140, an increase of 97% since June 30, 2022
- A PMA supplement was filed with the
FDA for Barostim indication expansion in June 2023, in line with
BeAT-HF executive steering committee's recommendation
"We are pleased to report another impressive quarter. Our
success continues to be driven by our U.S. heart failure business,
which saw revenue growth of nearly 120% compared to the prior year
quarter. We are proud of our performance, which reflects the
continued execution of our commercial strategy and the demand for
Barostim in the market,” said Nadim Yared, President and Chief
Executive Officer of CVRx. “As we move forward, we remain
determined to sustain this positive momentum throughout the year.
We extend our gratitude to our exceptional team for their
relentless dedication to our mission of giving each patient a
fuller life.”
Second Quarter 2023 Financial and Operating
Results
Revenue was $9.5 million for the three months ended June 30,
2023, an increase of $4.5 million, or 89%, over the three months
ended June 30, 2022.
Revenue generated in the U.S. was $8.3 million for the three
months ended June 30, 2023, an increase of $4.4 million, or 111%,
over the three months ended June 30, 2022. HF revenue units in the
U.S. totaled 265 and 128 for the three months ended June 30, 2023
and 2022, respectively. HF revenue in the U.S. totaled $8.3 million
and $3.8 million for the three months ended June 30, 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 June 30, 2023, the Company had a total of 140 active
implanting centers, as compared to 122 as of March 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 three to a total of 32 during
the three months ended June 30, 2023.
Revenue generated in Europe was $1.2 million for the three
months ended June 30, 2023, an increase of $0.1 million, or 10%,
over the three months ended June 30, 2022. Total revenue units in
Europe increased to 56 for the three months ended June 30, 2023
from 52 in the prior year period. The number of sales territories
in Europe remained consistent at six for the three months ended
June 30, 2023.
Gross profit was $8.0 million for the three months ended June
30, 2023, an increase of $4.2 million, or 108%, over the three
months ended June 30, 2022. Gross margin increased to 84% for the
three months ended June 30, 2023 compared to 76% for the three
months ended June 30, 2022. This increase was due primarily to a
decrease in the cost per unit driven by an increase in the
production volume.
R&D expenses increased $0.9 million, or 39%, to $3.3 million
for the three months ended June 30, 2023 compared to the three
months ended June 30, 2022. This change was driven by a $0.6
million increase in compensation expenses as a result of increased
headcount, a $0.1 million increase in non-cash stock-based
compensation expense and a $0.1 million increase in consulting
fees.
SG&A expenses increased $4.0 million, or 32%, to $16.5
million for the three months ended June 30, 2023 compared to the
three months ended June 30, 2022. This change was primarily driven
by a $2.5 million increase in compensation expenses, mainly as a
result of increased headcount, a $0.8 million increase in marketing
and advertising expenses associated with the commercialization of
Barostim in the U.S., a $0.4 million increase in travel expenses,
and a $0.3 million increase in non-cash stock-based compensation
expense.
Interest expense increased $0.5 million for the three months
ended June 30, 2023 compared to the three months ended June 30,
2022. This increase was driven by the interest expense on
borrowings under the loan agreement entered into on October 31,
2022.
Other income, net was $0.6 million for the three months ended
June 30, 2023 compared to other expense, net of $34,000 for the
three months ended June 30, 2022. The income in the second quarter
of 2023 was primarily driven by interest income on interest-bearing
accounts.
Net loss was $11.7 million, or $0.56 per share, for the three
months ended June 30, 2023, compared to a net loss of $11.1
million, or $0.54 per share, for the three months ended June 30,
2022. Net loss per share was based on 20,711,850 weighted average
shares outstanding for three months ended June 30, 2023 and
20,505,228 weighted average shares outstanding for the three months
ended June 30, 2022.
As of June 30, 2023, cash and cash equivalents were $90.8
million. Net cash used in operating and investing activities was
$12.95 million for the quarter ended June 30, 2023, which included
our annual premium for our directors and officers insurance of
approximately $2 million. This is compared to net cash used in
operating and investing activities of $10.5 million for the three
months ended March 31, 2023.
Business Outlook
For the full year of 2023, the Company now expects:
- Total revenue
between $37.0 million and $38.5 million; up from previously issued
guidance of $35.5 million and $38.0 million
- Gross margin
between 83.0% and 84.0%; up from previously issued guidance of
80.0% and 83.0%;
- Operating expenses
between $78.0 million and $80.0 million; up from previously issued
guidance of $76.0 million and $80.0 million.
For the third quarter of 2023, the Company expects to report
total revenue between $9.5 million and $10.2 million.
Webcast and Conference Call Information
The Company will host a conference call to review its results at
5:30 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 third quarter 2023 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)
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
90,815 |
|
|
$ |
106,194 |
|
Accounts receivable, net of allowances of $602 and $679,
respectively |
|
|
6,726 |
|
|
|
5,504 |
|
Inventory |
|
|
10,928 |
|
|
|
6,957 |
|
Prepaid expenses and other current assets |
|
|
3,543 |
|
|
|
4,223 |
|
Total current assets |
|
|
112,012 |
|
|
|
122,878 |
|
Property and equipment, net |
|
|
1,821 |
|
|
|
1,698 |
|
Operating lease right-of-use
asset |
|
|
1,113 |
|
|
|
334 |
|
Other non-current assets |
|
|
27 |
|
|
|
27 |
|
Total assets |
|
$ |
114,973 |
|
|
$ |
124,937 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,933 |
|
|
$ |
1,719 |
|
Accrued expenses |
|
|
5,992 |
|
|
|
6,369 |
|
Total current liabilities |
|
|
8,925 |
|
|
|
8,088 |
|
Long-term debt |
|
|
14,253 |
|
|
|
6,747 |
|
Operating lease liability,
non-current portion |
|
|
946 |
|
|
|
117 |
|
Other long-term liabilities |
|
|
885 |
|
|
|
805 |
|
Total liabilities |
|
|
25,009 |
|
|
|
15,757 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, $0.01 par value,
200,000,000 authorized as of June 30, 2023 and
December 31, 2022; 20,750,910 and 20,663,736 shares
issued and outstanding as of June 30, 2023 and
December 31, 2022, respectively |
|
|
208 |
|
|
|
207 |
|
Additional paid-in capital |
|
|
549,150 |
|
|
|
545,362 |
|
Accumulated deficit |
|
|
(459,207 |
) |
|
|
(436,182 |
) |
Accumulated other comprehensive
loss |
|
|
(187 |
) |
|
|
(207 |
) |
Total stockholders’ equity |
|
|
89,964 |
|
|
|
109,180 |
|
Total liabilities and stockholders’ equity |
|
$ |
114,973 |
|
|
$ |
124,937 |
|
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 |
|
|
June 30, |
|
June 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue |
|
$ |
9,500 |
|
|
$ |
5,031 |
|
|
$ |
17,479 |
|
|
$ |
9,107 |
|
Cost of goods sold |
|
|
1,517 |
|
|
|
1,201 |
|
|
|
2,845 |
|
|
|
2,150 |
|
Gross profit |
|
|
7,983 |
|
|
|
3,830 |
|
|
|
14,634 |
|
|
|
6,957 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,280 |
|
|
|
2,355 |
|
|
|
6,696 |
|
|
|
4,613 |
|
Selling, general and administrative |
|
|
16,455 |
|
|
|
12,489 |
|
|
|
31,852 |
|
|
|
23,266 |
|
Total operating expenses |
|
|
19,735 |
|
|
|
14,844 |
|
|
|
38,548 |
|
|
|
27,879 |
|
Loss from operations |
|
|
(11,752 |
) |
|
|
(11,014 |
) |
|
|
(23,914 |
) |
|
|
(20,922 |
) |
Interest expense |
|
|
(481 |
) |
|
|
— |
|
|
|
(721 |
) |
|
|
— |
|
Other income (expense), net |
|
|
616 |
|
|
|
(34 |
) |
|
|
1,678 |
|
|
|
(91 |
) |
Loss before income taxes |
|
|
(11,617 |
) |
|
|
(11,048 |
) |
|
|
(22,957 |
) |
|
|
(21,013 |
) |
Provision for income taxes |
|
|
(34 |
) |
|
|
(23 |
) |
|
|
(68 |
) |
|
|
(49 |
) |
Net loss |
|
|
(11,651 |
) |
|
|
(11,071 |
) |
|
|
(23,025 |
) |
|
|
(21,062 |
) |
Cumulative translation
adjustment |
|
|
17 |
|
|
|
(7 |
) |
|
|
20 |
|
|
|
(13 |
) |
Comprehensive loss |
|
$ |
(11,634 |
) |
|
$ |
(11,078 |
) |
|
$ |
(23,005 |
) |
|
$ |
(21,075 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.56 |
) |
|
$ |
(0.54 |
) |
|
$ |
(1.11 |
) |
|
$ |
(1.03 |
) |
Weighted-average common shares
used to compute net loss per share, basic and diluted |
|
|
20,711,850 |
|
|
|
20,505,228 |
|
|
|
20,702,589 |
|
|
|
20,479,427 |
|
Grafico Azioni CVRx (NASDAQ:CVRX)
Storico
Da Apr 2024 a Mag 2024
Grafico Azioni CVRx (NASDAQ:CVRX)
Storico
Da Mag 2023 a Mag 2024