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CVRx Reports Third Quarter 2021 Financial and Operating Results Third Quarter 2021 Revenue of $3.4 million, a 241% Increase Over Prior Year MINNEAPOLIS

Key Takeaway: CVRx Reports Third Quarter 2021 Financial and Third Quarter 2021 Revenue of $3.4 million, a 241% Increase Over Prior Year MINNEAPOLIS, November 4, 2021 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), a commercial-stage medical device company focused on developing, man

Full Press Release Details

CVRx Reports Third Quarter 2021 Financial and
Third Quarter 2021 Revenue of $3.4 million,
a 241% Increase Over Prior Year
MINNEAPOLIS, November 4, 2021 (GLOBE NEWSWIRE) -- CVRx, Inc.
(NASDAQ: CVRX) ("CVRx"), a commercial-stage medical device company focused on developing, manufacturing and commercializing
innovative and minimally invasive neuromodulation solutions for patients with cardiovascular diseases, today announced its financial and
operating results for the third quarter of 2021.
"We are very encouraged by our performance in the quarter. Like
other procedure-based companies, we experienced COVID-19 Delta variant related headwinds in the quarter, but were able to navigate through
those challenges to deliver for our customers. We are particularly encouraged by the performance of our U.S. heart failure business, which
continues to show strong early adoption trends," said Nadim Yared, President and Chief Executive Officer of CVRx. "Looking
ahead, we remain focused on the expansion of our U.S. commercial organization in an effort to drive wide-spread adoption. We will continue
to engage with new customers, train surgeons, and onboard new active implanting facilities, in addition to supporting existing customers
to grow their utilization of Barostim to bring relief to patients suffering from cardiovascular diseases."
Third Quarter 2021 Financial and Operating Results
Revenue by Geography
Three months ended September 30,
2021 2020
Amount Amount % Change
(dollars in thousands)
United States $ 2,572 $ 296 769 %
Europe 823 701 17 %
Total Revenue $ 3,395 $ 997 241 %
United States Revenue by Product Category
Three months ended September 30,
2021 2020
Amount Amount % Change
(dollars in thousands)
U.S. Heart Failure (HF) $ 2,468 $ 140 NM
U.S. Legacy Hypertension 104 156 (33 )%
Total U.S. Revenue $ 2,572 $ 296 769 %
Revenue was $3.4 million for the three months ended September 30,
2021, an increase of $2.4 million, or 241%, over the three months ended September 30, 2020.
Revenue generated in the U.S. was $2.6 million for the three months
ended September 30, 2021, an increase of $2.3 million, or 769%, over the three months ended September 30, 2020. HF revenue units
in the U.S. totaled 84 and four for the three months ended September 30, 2021 and 2020, respectively. HF revenue in the U.S. totaled
$2.5 million and $140,000 for the three months ended September 30, 2021 and 2020, respectively. The increase was primarily driven
by continued growth following the U.S. HF commercial launch in 2020, which resulted in the expansion into new sales territories and increased
physician and patient awareness of Barostim.
As of September 30, 2021, the Company had a total of 38 active
implanting centers, as compared to 31 as of June 30, 2021. 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 eleven during
the three months ended September 30, 2021.
Revenue generated in Europe was $0.8 million for the three months ended
September 30, 2021, an increase of $0.1 million, or 17%, over the three months ended September 30, 2020. Total revenue units
in Europe increased to 38 from 32 for the three months ended September 30, 2021 and 2020, respectively. The slight revenue increase
was primarily due the lessening impact of the COVID-19 pandemic in Germany. The number of sales territories in Europe remained consistent
at six during the three months ended September 30, 2021.
profit was $2.5 million for the three months ended September 30, 2021, an increase of $1.7 million, or 221%, over the three months
ended September 30, 2020. Gross margin decreased to 74% for the three months ended September 30, 2021 compared to 79% for the
three months ended September 30, 2020. Gross margin for the three months ended September 30, 2021 was lower due to a
larger percentage of our revenue units coming from full systems, which require an Implantable Pulse Generator (IPG) and a stimulation
lead, as compared to individual IPG sales. This was partially offset by an increase in the average selling price.
R&D expenses increased $0.2 million, or 13%, to $1.7 million for
the three months ended September 30, 2021 compared to the three months ended September 30, 2020. This change was primarily due
to an increase of $0.1 million in non-cash stock-based compensation expense, and an increase of $0.1 million in compensation expenses,
including salaries and other employee-related expenses, mainly as a result of increased headcount.
SG&A expenses increased $5.8 million, or 249%, to $8.1 million
for the three months ended September 30, 2021 compared to the three months ended September 30, 2020. This change was driven
by an increase of $2.8 million in compensation expenses, including salaries and commissions, and other employee-related expenses, mainly
as a result of increased headcount, a $0.8 million increase in marketing and advertising expenses primarily related to the commercial
launch of Barostim in the U.S., a $0.7 million increase in insurance costs incurred as a result of the IPO, $0.4 million of additional
travel expenses, a $0.3 million increase in non-cash stock-based compensation expense, and a $0.3 million increase in consulting expenses.
Other income, net was $1.8 million for the three months ended September 30,
2021 compared to $0.5 million for the three months ended September 30, 2020, driven by a $1.5 million decrease in fair value of the
convertible preferred stock warrant liability due to the change in the common stock price from June 30, 2021 to July 2, 2021,
which is the date the warrants converted to common stock warrants.
Net loss was $6.1 million, or $0.30 per share, for the three months
ended September 30, 2021, compared to a net loss of $3.2 million, or $9.56 per share, for the three months ended September 30,
2020. Net loss per share was based on 20,126,672 and 360,356 weighted average shares outstanding for the third quarter of 2021 and 2020,
As of September 30, 2021, cash and cash equivalents were $170.9
million compared to $47.1 million as of June 30, 2021. Net cash used in operating and investing activities was $9.4 million for the
three months ended September 30, 2021.
For the full year of 2021, the Company continues to expect:
For the fourth quarter of 2021, the Company expects to report total
revenue between $3.9 million and $4.5 million.
In the last two months the Company filed three separate PMA Supplement
submissions with the U.S. Food and Drug Administration (FDA), all of which relate to the development of its Barostim platform, for the
Approval for the three PMA Supplement submissions is expected in the
On November 3, 2021, the Company fully repaid its $20 million
loan with Horizon Technology Finance Corporation. The total repayment cost of $21.3 million, inclusive of prepayment and other fees, will
be reflected in the fourth quarter.
Following the repayment, the Company believes it has more than three
years of cash on hand to fund operations.
Webcast and Conference Call Information
Company will host a conference call at 5:30 pm Eastern Time on November 4, 2021 to discuss results of the quarter as well as a question
and answer session. To listen to the conference call on your telephone, please dial (833) 730-3980 for U.S. callers, or +1 (720) 405-2140
for international callers, approximately ten minutes prior to the start time and reference conference code 6038756. To listen to a live
webcast, please visit the Investors section of the CVRx website at: ir.cvrx.com/news-events/events. The webcast replay will be
available on the CVRx website for 12 months following completion of the call.
CVRx is focused on the development and commercialization of Barostim ,
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 financial guidance regarding full year 2021 results and expectations about regulatory approvals,
liquidity and cash resources and adoption of our Barostim therapy. 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 NEO; our ability to establish and maintain sales and marketing capabilities; our ability to demonstrate to physicians
and patients the merits of our BAROSTIM NEO; any failure by third-party payors to provide adequate coverage and reimbursement for the
use of BAROSTIM NEO; our competitors' success in developing and marketing products that are safer, more effective, less costly,
Last updated: Nov 4, 2021