Full Press Release Details
CVRx Reports First Quarter 2022 Financial and
First Quarter 2022 Revenue of $4.1 million,
a 43% Increase Over Prior Year
MINNEAPOLIS, April 25, 2022 (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
"I am very pleased with the progress we have made in the first
quarter as we continued to drive the adoption of Barostim - growing U.S. heart failure revenue by 133% year over year, expanding our
U.S. active implanting centers and delivering a record number of revenue units - despite a highly challenging macro environment early
in the year," said Nadim Yared, President and Chief Executive Officer of CVRx. "With the expansion of our U.S. commercial
organization, increased awareness among physicians and patients of the benefits of Barostim, and recent regulatory progress within our
product portfolio, we believe we are in a strong position to continue to drive adoption of Barostim and provide a solution to individuals
suffering from cardiovascular disease."
First Quarter 2022 Financial and Operating Results
| Revenue by Product Category/Geography | ||||||||||||
| Three months ended March 31, | ||||||||||||
| 2022 | 2021 | ` | ||||||||||
| Amount | Amount | % Change | ||||||||||
| (dollars in thousands) | ||||||||||||
| U.S. Heart Failure (HF) | $ | 2,928 | $ | 1,257 | 133 | % | ||||||
| U.S. Legacy Hypertension | 130 | 354 | (63 | )% | ||||||||
| United States | 3,058 | 1,612 | 90 | % | ||||||||
| Europe | 1,018 | 1,248 | (18 | )% | ||||||||
| Total Revenue | $ | 4,076 | $ | 2,860 | 43 | % |
$4.1 million for the three months ended March 31, 2022, an increase of $1.2 million, or 43%, over the three months ended March 31, 2021.
Revenue generated in the U.S. was $3.1 million for the three months
ended March 31, 2022, an increase of $1.4 million, or 90%, over the three months ended March 31, 2021. HF revenue units in the U.S. totaled
99 and 44 for the three months ended March 31, 2022 and 2021, respectively. HF revenue in the U.S. totaled $2.9 million for the three
months ended March 31, 2022, an increase of $1.6 million, or 133% over the three months ended March 31, 2021. The increase was 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, 2022, the Company had a total of 56 active implanting
centers as compared to 19 as of March 31, 2021. Active implanting centers are customers that have completed at least one commercial HF
implant in the last 12 months. As of March 31, 2022, the Company had a total of 17 sales territories as compared to 6 as of March 31,
Revenue generated in Europe was $1.0 million for the three months
ended March 31, 2022, a decrease of $0.2 million, or 18%, over the three months ended March 31, 2021. Total revenue units in Europe were
50 for the three months ended March 31, 2022 as compared to 52 in the prior year period. The decrease is due to reduced procedure volumes
due to COVID-related headwinds. As of March 31, 2022, the Company had a total of six sales territories in Europe.
Gross profit was $3.1 million for the three months ended March 31,
2022, an increase of $1.1 million, or 57%, over the three months ended March 31, 2021. Gross margin increased to 77% for the three months
ended March 31, 2022, compared to 70% for the three months ended March 31, 2021. Gross margin for the three months ended March 31, 2022
was higher due to a decrease in the cost per unit and an increase in the average selling price. This was partially offset by a larger
percentage of our revenue units coming from full systems versus battery replacements. New patients receive a full system that includes
an IPG and a stimulation lead and have a lower gross margin than a stand-alone IPG used for a battery replacement.
R&D expenses increased $0.5 million, or 29%, to $2.3 million for
the three months ended March 31, 2022 compared to the three months ended March 31, 2021. This change was primarily driven by an increase
in compensation expenses, mainly as a result of increased headcount, an increase in clinical study expenses and an increase in non-cash
stock-based compensation expense.
SG&A expenses increased $6.3 million, or 142%, to $10.8 million
for the three months ended March 31, 2022 compared to the three months ended March 31, 2021. This was primarily driven by an increase
in compensation expenses, mainly as a result of increased headcount, and an increase in marketing and advertising expenses associated
with the commercialization of Barostim in the U.S.
Other expense, net was $0.1 million for the three months ended March
31, 2022 compared to $3.8 million for the three months ended March 31, 2021. The expense in the first quarter of 2021 was primarily driven
by the increase in fair value of the convertible preferred stock warrant liability from December 31, 2020 to March 31, 2021. As these
preferred stock warrants converted to common stock warrants upon the IPO, there is no longer a change in fair value recorded into other
Net loss was $10.0 million, or $0.49 per share, for the three months
ended March 31, 2022, compared to a net loss of $8.6 million, or $23.92 per share, for the three months ended March 31, 2021. Net loss
per share was based on 20,453,341 and 360,675 weighted average shares outstanding for the three months ended March 31, 2022 and 2021,
Cash and cash equivalents were $131.2 million as of March 31, 2022,
compared to $142.1 million as of December 31, 2021.
For the full year of 2022, the Company continues to expect:
For the second quarter of 2022, the Company expects to report total
revenue between $4.5 million and $5.0 million.
Subsequent to the end of the first quarter, the Company received FDA
approval for a new programmer, which provides even simpler programming software in a tablet form factor.
Webcast and Conference Call Information
will host a conference call at 4:30 pm Eastern Time on April 25, 2022 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 8433167. 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 2022 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; 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, 2021, 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