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CVRX Positive Sentiment Score: 75/100

CVRx Reports First Quarter 2023 Financial and Operating Results MINNEAPOLIS

Key Takeaway: CVRx, Inc. reported positive financial results for Q1 2023, with a notable revenue growth of 96% year-over-year, reaching $8.0 million. The company expanded its U.S. heart failure business with an increase in active implanting centers and sales territories. Despite these gains, CVRx experienced a net loss of $11.4 million, and expenses in R&D saw a significant rise. Overall, the results reflect strong execution but underline ongoing financial challenges faced by the company.

Market Sentiment Analysis

POSITIVE FACTORS

  • Revenue increased by 96% year-over-year, showing strong growth.
  • Successful expansion of the U.S. heart failure business with a rise in active implanting centers.
  • Gross profit increased significantly, reflecting improved margins due to reduced costs per unit.

CONCERNS & RISKS

  • Net loss increased to $11.4 million, indicating ongoing financial challenges.
  • R&D expenses rose significantly, which could impact future profitability.

Full Press Release Details

CVRx Reports First Quarter 2023 Financial and
MINNEAPOLIS, April 27, 2023 (GLOBE NEWSWIRE) -- 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.
"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.
For the full year of 2023, the Company expects:
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.
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.
Mark Klausner or Mike Vallie
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
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

Frequently Asked Questions

What is CVRx focused on?

CVRx specializes in developing neuromodulation solutions for cardiovascular diseases.

How much revenue did CVRx report in Q1 2023?

CVRx reported $8.0 million in revenue for the first quarter of 2023.

What is Barostim?

Barostim is an implantable device that treats heart failure by delivering electrical pulses.

What was CVRx's net loss in Q1 2023?

CVRx incurred a net loss of $11.4 million for the first quarter of 2023.

What are the expected Q2 2023 revenues for CVRx?

CVRx anticipates total revenue between $8.2 million and $8.8 million for Q2 2023.

Last updated: Apr 27, 2023