CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical
device company, announced today certain preliminary unaudited
fourth quarter and full year 2023 revenue results as well as its
2024 business outlook. The Company also announced that President
and Chief Executive Officer, Nadim Yared, has informed the Board of
Directors of his plans to retire following the selection and
appointment of his successor.
Fourth Quarter 2023
Total revenue for the fourth quarter of 2023 is expected to be
in the range of approximately $11.2 million to $11.3 million,
representing an increase of approximately 56% to 58% over fourth
quarter 2022 revenue of $7.2 million. Total revenue generated in
the fourth quarter of 2023 is expected to be comprised of
approximately $10.2 million in U.S. heart failure revenue, $1.0
million in European revenue and $0.1 million in U.S. legacy
revenue.
Full Year 2023
Total revenue for full year 2023 is expected to be in the range
of approximately $39.2 million to $39.3 million, representing an
increase of approximately 74% to 75% over full year 2022 revenue of
$22.5 million. Total revenue generated in 2023 is expected to be
comprised of approximately $34.6 million in U.S. heart failure
revenue, $4.2 million in European revenue and $0.5 million in U.S.
legacy revenue.
As of December 31, 2023, the Company had a total of 178 active
implanting centers, as compared to 159 as of September 30, 2023.
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.
As of December 31, 2023, cash and cash equivalents were $91
million.
“2023 was another fantastic year for CVRx,” said Nadim Yared,
President and Chief Executive Officer of CVRx. “We continued to
drive the adoption and utilization of Barostim, evidenced by the
97% increase in U.S. heart failure revenue. In addition, we
announced several positive catalysts during the year, including the
recently announced expansion of Barostim labeling as well as CMS’
OPPS ruling to reassign Barostim to a new APC code, which we
believe will facilitate increased access to the therapy for
Medicare patients with heart failure by offering facilities
sufficient reimbursement for the procedure.”
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% and 84%;
- 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.
CEO Retirement Plans and Initiation of Search
Process
The Company’s current President and Chief Executive Officer,
Yared, has informed the Board of Directors of his plans to retire.
Both he and the Board are committed to a planful and deliberate
process to identify his successor, and Yared will remain in his
current role until a new CEO is appointed. The Board is currently
conducting a search to identify a new CEO with the assistance of a
leading executive search firm.
“As we look to 2024, we are very excited about the prospects for
the Company and the expanded penetration of Barostim. Based on the
Company’s strong position, excellent leadership team, consistent
execution of our strategy over the last two years, and the
opportunity that lies in front of us, the Company is
well-positioned to attract a high-caliber CEO who can continue to
execute on our strategic plans and drive future commercial growth,”
Yared said. “My 17 years as CEO of CVRx have been an
incredible experience and honor, and I look forward to continuing
to serve the Company and support the Board throughout this
transition.”
“The Board of Directors is grateful to Nadim for his
extraordinary leadership and his commitment since his arrival at
CVRx in 2006. He has worked tirelessly to transform Barostim from
an intriguing concept into a commercially successful FDA-approved
therapy, and CVRx into a thriving public company,” said Kirk
Nielsen, lead independent director. “Nadim has contributed
tremendously to the success of CVRx, and we look forward to working
closely with him to identify his successor and support a seamless
transition.”
Upcoming Investor Conference Presentation
The Company will be participating in the 42nd Annual J.P.
Morgan Healthcare Conference, including a company presentation on
Wednesday, January 10, 2024 at 3:45 pm Pacific Time. A live audio
webcast of the conference presentation will be available
online at the investor relations page of the Company’s website
at ir.cvrx.com.
About CVRx, Inc.
CVRx is focused on the development and commercialization of the
Barostim™ System, the first medical technology approved by FDA that
uses neuromodulation to improve the symptoms of 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 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.
Preliminary Fourth Quarter/Full Year 2023
Results
This press release includes estimated financial results for the
fourth quarter and full year of 2023, which are preliminary,
unaudited and represent the most recent current information
available to Company management. The Company’s actual results
may differ from these estimated financial results, including due to
the completion of its financial closing procedures and final
adjustments. The Company expects to issue full financial
results for the fourth quarter and full year 2023 in late
January.
Media Contact:Laura O’NeillFinn
Partners402-499-8203laura.oneill@finnpartners.com
Investor Contact:Mark Klausner or Mike
VallieICR Westwicke443.213.0501ir@cvrx.com
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