CVRx, Inc. (“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 fourth quarter and full year of 2023, and affirmed its 2024
business outlook.
Recent Highlights
- Total revenue for the fourth
quarter of 2023 was $11.3 million, an increase of 58% over the
prior year quarter
- U.S. Heart Failure (HF) revenue for
the fourth quarter of 2023 was $10.2 million compared to $6.0
million in the prior year quarter, an increase of 70% over the
prior year quarter
- Total revenue for 2023 was $39.3
million, an increase of 75% over the prior year
- Active implanting centers for 2023
increased to 178, a 68% increase since December 31, 2022
- As previously announced, President
and CEO Nadim Yared plans to retire upon the completion of a
deliberate succession process and the appointment of a
successor
"As we reflect on the accomplishments of 2023, it has been a
great year for CVRx. We are proud to have sustained the momentum in
driving the adoption and utilization of Barostim, resulting in a
97% annual increase in U.S. heart failure revenue,” said Nadim
Yared, President and CEO of CVRx. “Additionally, we achieved
significant milestones, such as the expansion of Barostim labeling
and CMS' OPPS ruling assigning Barostim to the New Technology
payment code. We believe these changes will enhance access to our
therapy.”
“Turning our focus to 2024, we're enthusiastic about CVRx's
future and the ongoing commercial adoption of Barostim. With a
strong foundation, an exceptional leadership team, and consistent
execution of our strategy over the last two years, we are confident
in our ability to attract a high-caliber CEO. This individual will
play a crucial role in executing our strategic plans and driving
future commercial growth. Serving as CEO of CVRx has been an
incredible experience and privilege, and I look forward to
continuing to contribute to the Company’s success through this
transition."
Fourth Quarter 2023 Financial and Operating
Results
Revenue was $11.3 million for the three months ended December
31, 2023, an increase of $4.1 million, or 58%, over the three
months ended December 31, 2022.
Revenue generated in the U.S. was $10.3 million for the three
months ended December 31, 2023, an increase of $4.3 million, or
72%, over the three months ended December 31, 2022. HF revenue
units in the U.S. totaled 330 and 193 for the three months ended
December 31, 2023 and 2022, respectively. HF revenue in the U.S.
totaled $10.2 million and $6.0 million for the three months ended
December 31, 2023 and 2022, respectively. The increase was
primarily driven by continued growth as a result of the expansion
into new sales territories and new accounts, as well as increased
physician and patient awareness of Barostim.
As of December 31, 2023, the Company had a total of 178 active
implanting centers, as compared to 159 as of September 30, 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
38 during the three months ended December 31, 2023. A sales
territory is an established regional area held by an account
manager, typically after at least six months of employment.
Revenue generated in Europe was $1.0 million for the three
months ended December 31, 2023, a decrease of $0.2 million, or 15%,
over the three months ended December 31, 2022. Total revenue units
in Europe decreased to 52 for the three months ended December 31,
2023 from 68 in the prior year period. The number of sales
territories in Europe remained consistent at six during the three
months ended December 31, 2023.
Gross profit was $9.6 million for the three months ended
December 31, 2023, an increase of $3.9 million, or 69%, over the
three months ended December 31, 2022. Gross margin increased to 85%
for the three months ended December 31, 2023 compared to 79% for
the three months ended December 31, 2022. Gross margin for the
three months ended December 31, 2023 was higher due to a decrease
in the cost per unit and an increase in the average selling
price.
R&D expenses decreased $0.8 million, or 26%, to $2.2 million
for the three months ended December 31, 2023 compared to the three
months ended December 31, 2022. This change was primarily driven by
a $0.7 million decrease in clinical study expenses and a $0.6
million decrease in consulting expenses, partially offset by a $0.3
million increase in compensation expenses, mainly as a result of
increased headcount and a $0.1 million increase in non-cash
stock-based compensation expense.
SG&A expenses increased $2.9 million, or 21%, to $17.0
million for the three months ended December 31, 2023 compared to
the three months ended December 31, 2022. This change was driven by
a $1.7 million increase in compensation expenses, mainly as a
result of increased headcount, a $0.7 million increase in marketing
and advertising expenses, primarily related to the
commercialization of Barostim in the U.S., a $0.4 million increase
in non-cash stock-based compensation expense and a $0.4 million
increase in consulting expenses, partially offset by a $0.1 million
decrease related to D&O insurance costs and a $0.1 million
decrease in professional fees.
Interest expense increased $0.4 million to $0.6 million for the
three months ended December 31, 2023 compared to the three months
ended December 31, 2022. This change was driven by the interest
expense on borrowings under the loan agreement entered into on
October 31, 2022.
Other income, net was $1.1 million for each of the three months
ended December 31, 2023 and 2022. Other income, net consisted
primarily of income on interest-bearing accounts.
Net loss was $9.2 million, or $0.44 per share, for the three
months ended December 31, 2023, compared to a net loss of $10.5
million, or $0.51 per share, for the three months ended December
31, 2022. Net loss per share was based on 20,826,634 weighted
average shares outstanding for three months ended December 31, 2023
and 20,593,312 weighted average shares outstanding for the three
months ended December 31, 2022.
Full Year 2023 Financial and Operating
Results
Revenue was $39.3 million for the year ended December 31, 2023,
an increase of $16.8 million, or 75%, over the year ended December
31, 2022.
Revenue generated in the U.S. was $35.1 million for the year
ended December 31, 2023, an increase of $17.1 million, or 95%, over
the year ended December 31, 2022. Total HF revenue units in the
U.S. totaled 1,123 and 587 for the years ended December 31, 2023
and 2022, respectively. HF revenue in the U.S. totaled $34.6
million and $17.6 million for the years ended December 31, 2023 and
2022, respectively.
As of December 31, 2023, the Company had a total of 178 active
implanting centers, as compared to 106 as of December 31, 2022. The
number of sales territories in the U.S. increased by 12 to a total
of 38 during the year ended December 31, 2023.
Revenue generated in Europe was $4.2 million for the year ended
December 31, 2023, a decrease of $0.3 million, or 6%, over the year
ended December 31, 2022. Total revenue units in Europe decreased to
207 for the year ended December 31, 2023, from 231 for the prior
year period. The number of sales territories in Europe remained
consistent at six during the year ended December 31, 2023.
Gross profit was $33.0 million for the year ended December 31,
2023, an increase of $15.6 million, or 89%, over the year ended
December 31, 2022. Gross margin increased to 84% for the year ended
December 31, 2023, compared to 78% for the year ended December 31,
2022. Gross margin for the year ended December 31, 2023 was higher
due to a decrease in the cost per unit and an increase in the
average selling price.
R&D expenses increased $1.7 million, or 17%, to $11.6
million for the year ended December 31, 2023, compared to the year
ended December 31, 2022. This change was primarily driven by a $1.7
million increase in compensation expenses, mainly as a result of
increased headcount and a $0.6 million increase in non-cash
stock-based compensation expense, partially offset by a $0.8
million decrease in clinical study expenses.
SG&A expenses increased $14.5 million, or 29%, to $64.5
million for the year ended December 31, 2023, compared to the year
ended December 31, 2022. This change was driven by a $8.6 million
increase in compensation expenses, mainly as a result of increased
headcount, a $2.3 million increase in marketing and advertising
expenses, primarily related to the commercialization of Barostim in
the U.S., a $1.8 million increase in non-cash stock-based
compensation expense, a $1.5 million increase in travel expenses
and a $1.0 million increase in consulting expenses, partially
offset by a $0.3 million decrease related to D&O insurance
costs and a $0.2 million decrease in professional fees.
Interest expense increased $1.6 million to $1.8 million for the
year ended December 31, 2023 compared to the year ended December
31, 2022.This change was driven by the interest expense on
borrowings under the loan agreement entered into on October 31,
2022.
Other income, net was $3.9 million for the year ended December
31, 2023, compared to other income, net of $1.4 million for the
year ended December 31, 2022. This increase was primarily driven by
higher interest rates on interest-bearing accounts partially offset
by a lower cash balance.
Net loss was $41.2 million, or $1.99 per share, for the year
ended December 31, 2023, compared to a net loss of $41.4 million,
or $2.02 per share, for the year ended December 31, 2022.
As of December 31, 2023, cash and cash equivalents were $90.6
million. Net cash used in operating and investing activities was
$39.6 million for the year ended December 31, 2023, compared to
$43.4 million for the year ended December 31, 2022.
Business Outlook
For the full year of 2024, the Company expects:
- Total revenue
between $53.0 million and $57.0 million;
- Gross margin
between 83.0% and 84.0%;
- Operating expenses
between $86.0 million and $90.0 million.
For the first quarter of 2024, the Company expects to report
total revenue between $11.0 million and $12.0 million.
Recent Developments
In the fourth quarter of 2023 and first quarter of 2024, the
Company announced the following business developments:
- CEO Retirement Plans
- In January 2024, current President and Chief Executive
Officer, Nadim Yared, announced his plans to retire. Both he and
the Board are committed to a measured and deliberate process to
identify his successor, and Mr. Yared will remain in his current
role until a new CEO is appointed.
- FDA
Approved Expanded Labeling for Barostim - In December
2023, the U.S. Food and Drug Administration approved revised
Instructions For Use for Barostim, incorporating key long-term
clinical data from the BeAT-HF randomized clinical trial. For more
information, please refer to the press release
HERE.
- Market
Opportunity Updated - In December 2023, the Company
announced an updated U.S. annual market opportunity for Barostim.
Based on the new long-term safety and efficacy data, the Company’s
commercial experience, and the new reimbursement assignment, the
number of patients considered to be eligible for Barostim therapy
by physicians was increased to 76,000 new patients or $2.2 billion
annually, as compared to the earlier estimate of 55,000 new
patients or $1.4 billion, representing increases of approximately
38% and 60%, respectively.
- CMS
Increased Outpatient Payment for Barostim Procedure - In
November 2023, the Centers for Medicare and Medicaid Services
reassigned the Barostim implant procedure to New Technology APC
1580, which carries an average payment amount of $45,000 effective
January 1, 2024, an increase from the prior average payment amount
of $29,000, with a Transitional Pass-Through Payment. The move is
expected to improve access to Barostim therapy for Medicare heart
failure patients by ensuring facilities receive adequate
reimbursement.
Webcast and Conference Call Information
The Company will host a conference call to review its results at
4:30 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 first 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 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 and in “Part 2, Item 1A. Risk Factors” in our
Quarterly Report on Form 10-Q for the quarter ended September 30,
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.Consolidated Balance
Sheets(In thousands, except share and per share
data) |
|
|
December 31, |
|
December 31, |
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
90,569 |
|
|
$ |
106,194 |
|
Accounts receivable, net of allowances of $508 and $679,
respectively |
|
|
7,551 |
|
|
|
5,504 |
|
Inventory |
|
|
10,983 |
|
|
|
6,957 |
|
Prepaid expenses and other current assets |
|
|
2,987 |
|
|
|
4,223 |
|
Total current assets |
|
|
112,090 |
|
|
|
122,878 |
|
Property and equipment, net |
|
|
1,763 |
|
|
|
1,698 |
|
Operating lease right-of-use
asset |
|
|
1,349 |
|
|
|
334 |
|
Other non-current assets |
|
|
27 |
|
|
|
27 |
|
Total assets |
|
$ |
115,229 |
|
|
$ |
124,937 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,884 |
|
|
$ |
1,719 |
|
Accrued expenses |
|
|
5,980 |
|
|
|
6,369 |
|
Total current liabilities |
|
|
7,864 |
|
|
|
8,088 |
|
Long-term debt |
|
|
29,222 |
|
|
|
6,747 |
|
Operating lease liability,
non-current portion |
|
|
1,160 |
|
|
|
117 |
|
Other long-term liabilities |
|
|
1,036 |
|
|
|
805 |
|
Total liabilities |
|
|
39,282 |
|
|
|
15,757 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, $0.01 par value,
200,000,000 authorized as of December 31, 2023 and
December 31, 2022; 20,879,199 and 20,663,736 shares
issued and outstanding as of December 31, 2023 and
December 31, 2022, respectively |
|
|
209 |
|
|
|
207 |
|
Additional paid-in capital |
|
|
553,326 |
|
|
|
545,362 |
|
Accumulated deficit |
|
|
(477,381 |
) |
|
|
(436,182 |
) |
Accumulated other comprehensive
loss |
|
|
(207 |
) |
|
|
(207 |
) |
Total stockholders’ equity |
|
|
75,947 |
|
|
|
109,180 |
|
Total liabilities and stockholders’ equity |
|
$ |
115,229 |
|
|
$ |
124,937 |
|
CVRx, INC.Consolidated Statements of
Operations and Comprehensive Loss(In thousands,
except share and per share data) |
|
|
|
Three months ended |
|
Year ended |
|
|
December 31, |
|
December 31, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue |
|
$ |
11,305 |
|
|
$ |
7,176 |
|
|
$ |
39,295 |
|
|
$ |
22,469 |
|
Cost of goods sold |
|
|
1,720 |
|
|
|
1,509 |
|
|
|
6,256 |
|
|
|
4,999 |
|
Gross profit |
|
|
9,585 |
|
|
|
5,667 |
|
|
|
33,039 |
|
|
|
17,470 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
2,241 |
|
|
|
3,046 |
|
|
|
11,633 |
|
|
|
9,952 |
|
Selling, general and administrative |
|
|
17,005 |
|
|
|
14,100 |
|
|
|
64,509 |
|
|
|
50,045 |
|
Total operating expenses |
|
|
19,246 |
|
|
|
17,146 |
|
|
|
76,142 |
|
|
|
59,997 |
|
Loss from operations |
|
|
(9,661 |
) |
|
|
(11,479 |
) |
|
|
(43,103 |
) |
|
|
(42,527 |
) |
Interest expense |
|
|
(579 |
) |
|
|
(165 |
) |
|
|
(1,799 |
) |
|
|
(165 |
) |
Other income, net |
|
|
1,116 |
|
|
|
1,136 |
|
|
|
3,850 |
|
|
|
1,373 |
|
Loss before income taxes |
|
|
(9,124 |
) |
|
|
(10,508 |
) |
|
|
(41,052 |
) |
|
|
(41,319 |
) |
Provision for income taxes |
|
|
(39 |
) |
|
|
(28 |
) |
|
|
(147 |
) |
|
|
(109 |
) |
Net loss |
|
|
(9,163 |
) |
|
|
(10,536 |
) |
|
|
(41,199 |
) |
|
|
(41,428 |
) |
Cumulative translation
adjustment |
|
|
1 |
|
|
|
12 |
|
|
|
— |
|
|
|
(9 |
) |
Comprehensive loss |
|
$ |
(9,162 |
) |
|
$ |
(10,524 |
) |
|
$ |
(41,199 |
) |
|
$ |
(41,437 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.44 |
) |
|
$ |
(0.51 |
) |
|
$ |
(1.99 |
) |
|
$ |
(2.02 |
) |
Weighted-average common shares
used to compute net loss per share, basic and diluted |
|
|
20,826,634 |
|
|
|
20,593,312 |
|
|
|
20,754,375 |
|
|
|
20,532,838 |
|
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