Full Press Release Details
CVRx Reports Second Quarter 2022 Financial and
Second quarter 2022 revenue of $5.0 million,
a 61% increase over prior year
MINNEAPOLIS, July 28, 2022 (GLOBE NEWSWIRE) -- 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 second quarter of 2022.
"I am very pleased with what we were able to accomplish in
the second quarter. The adoption of Barostim continues to accelerate as we execute on our strategy to expand our sales force and
leverage marketing initiatives to increase awareness while at the same time working with existing customers to help more
patients," said Nadim Yared, President and Chief Executive Officer of CVRx. "We anticipate a strong second half of the
year as we continue to generate momentum across the organization. We remain focused on prudently expanding our commercial
organization and promoting awareness of Barostim among physicians, hospitals and patients as a novel treatment for individuals
suffering from cardiovascular disease."
Second Quarter 2022 Financial and Operating Results
Revenue was $5.0 million for the three months ended June 30, 2022,
an increase of $1.9 million, or 61%, over the three months ended June 30, 2021.
Revenue generated in the U.S. was $3.9 million for the three months
ended June 30, 2022, an increase of $1.8 million, or 87%, over the three months ended June 30, 2021. Total HF revenue units in the U.S.
totaled 128 and 67 for the three months ended June 30, 2022 and 2021, respectively.
HF revenue in the U.S. totaled $3.8 million for the three months ended
June 30, 2022, an increase of $1.8 million, or 90%, over the three months ended June 30, 2021. The increase was primarily driven by continued
growth as a result of the expansion into new sales territories, new accounts and increased physician and patient awareness of Barostim.
As of June 30, 2022, we had a total of 71 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. As of June 30, 2022, the Company had a total of 20 sales territories as compared to eight as of June 30, 2021.
Revenue generated in Europe was $1.1 million for the three months ended
June 30, 2022, an increase of $0.1 million, or 7%, over the three months ended June 30, 2021. Total revenue units in Europe were 52 for
the three months ended June 30, 2022 as compared to 47 in the prior year period. The slight revenue increase was primarily due to the
lessening impact of the COVID-19 pandemic in Germany, partially offset by an unfavorable currency impact on net sales. As of June 30,
2022, the Company had a total of six sales territories in Europe.
Gross profit was $3.8 million for the three months ended June 30,
2022, an increase of $1.6 million, or 73%, over the three months ended June 30, 2021. Gross margin increased to 76% for the three
months ended June 30, 2022, compared to 71% for the three months ended June 30, 2021. Gross margin for the three months ended June
30, 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, which has a lower gross margin than a stand-alone IPG used for a battery
R&D expenses increased $0.1 million, or 4%, to $2.4 million for
the three months ended June 30, 2022, compared to the three months ended June 30, 2021. This change was primarily driven by an increase
in compensation expenses, mainly as a result of increased headcount, partially offset by a decrease in consulting expenses and non-cash
stock-based compensation expenses.
SG&A expenses increased $6.9 million, or 122%, to $12.5 million
for the three months ended June 30, 2022, compared to the three months ended June 30, 2021. This was primarily driven by an increase in
compensation expenses, mainly as a result of increased headcount, as well as increases in travel expenses, public company costs, marketing
and advertising expenses associated with the commercialization of Barostim in the U.S., and non-cash stock-based compensation expenses.
Other expense, net was nominal for the three months ended June 30,
2022, compared to $11.4 million for the three months ended June 30, 2021. The expense in the second quarter of 2021 was primarily driven
by the increase in fair value of the convertible preferred stock warrant liability from March 31, 2021 to June 30, 2021. As these preferred
stock warrants converted to common stock warrants upon the IPO, there is no longer a change in fair value recorded in other expense, net.
Net loss was $11.1 million, or $0.54 per share, for the three months
ended June 30, 2022, compared to a net loss of $17.7 million, or $48.48 per share, for the three months ended June 30, 2021. Net loss
per share was based on 20,505,228 and 366,066 weighted average shares outstanding for the second quarter of 2022 and 2021, respectively.
At the end of the current quarter, cash and cash equivalents were $121.3
million. Net cash used in operating and investing activities was $10.1 million for the current quarter, compared to $6.8 million for the
same period last year. We continue to prudently monitor our cash usage in support of our growth initiatives as we progress towards profitability.
For the full year of 2022, the Company now expects:
For the third quarter of 2022, the Company expects to report total
revenue between $5.5 million and $6.0 million.
During the second quarter, the Company received FDA approval for a
new programmer, which provides even simpler programming software in a tablet form factor, and magnetic resonance (MR) conditional labeling,
which allows MRI scanning with specific instructions for patients implanted with Barostim.
Webcast and Conference Call Information
will host a conference call at 5:30 pm Eastern Time on July 28, 2022 to discuss results of the quarter as well as a question and answer
session. The conference call will be broadcast live in listen-only mode via webcast at https://edge.media-server.com/mmc/p/8r349o6o.
To listen to the conference call on your telephone, participants may register for the call here. While it is not required,
it is recommended you join 10 minutes prior to the event start.
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 and third quarter 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