Full Press Release Details
CVRx Reports Third Quarter 2022 Financial and
Third quarter 2022 revenue of $6.2 million,
an 82% increase over prior year
MINNEAPOLIS, November 1, 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 third quarter of 2022.
"We are delighted with our performance during the third quarter
as the adoption and utilization of Barostim continues to accelerate. The growth in our commercial organization as well as the early success
of our marketing initiatives resulted in our U.S. Heart Failure revenue nearly doubling over the prior year quarter," said Nadim
Yared, President and Chief Executive Officer of CVRx. "Looking ahead, we will continue to build on our strategy to further drive
the proliferation of Barostim to bring this novel treatment to more patients who are suffering from cardiovascular disease."
Third Quarter 2022 Financial and Operating Results
Revenue was $6.2 million for the three months ended September 30,
2022, an increase of $2.8 million, or 82%, over the three months ended September 30, 2021.
Revenue generated in the U.S. was $5.0 million for the three months
ended September 30, 2022, an increase of $2.5 million, or 96%, over the three months ended September 30, 2021. Total HF revenue
units in the U.S. totaled 167 and 84 for the three months ended September 30, 2022 and 2021, respectively.
HF revenue in the U.S. totaled $4.9 million for the three months ended
September 30, 2022, an increase of $2.4 million, or 99%, over the three months ended September 30, 2021. The increase was primarily
driven by continued growth as a result of the expansion into new sales territories and new accounts, as well as increased physician and
patient awareness of Barostim.
As of September 30, 2022, we had a total of 91 active implanting
centers as compared to 38 as of September 30, 2021. Active implanting centers are customers that have completed at least one commercial
HF implant in the last 12 months. As of September 30, 2022, the Company had a total of 23 sales territories as compared to 11 as
of September 30, 2021.
Revenue generated in Europe was $1.1 million for the three months ended
September 30, 2022, an increase of $0.3 million, or 39%, over the three months ended September 30, 2021. Total revenue units
in Europe were 61 for the three months ended September 30, 2022 as compared to 38 in the prior year period. The 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 September 30, 2022, we had a total of six sales territories in Europe.
Gross profit was $4.8 million for the three months ended September 30,
2022, an increase of $2.3 million, or 92%, over the three months ended September 30, 2021. Gross margin increased to 78% for the
three months ended September 30, 2022, compared to 74% for the three months ended September 30, 2021. Gross margin for the three
months ended September 30, 2022 was higher due to a decrease in the cost per unit. This was partially offset by a decrease in the
average selling price and 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 $0.6 million, or 35%, to $2.3 million for
the three months ended September 30, 2022, compared to the three months ended September 30, 2021. This change was primarily
driven by a $0.5 million increase in compensation expenses, mainly as a result of increased headcount, and a $0.1 million increase in
non-cash stock-based compensation expense, partially offset by a $0.1 million decrease in clinical study expenses.
SG&A expenses increased $4.6 million, or 56%, to $12.7 million
for the three months ended September 30, 2022, compared to the three months ended September 30, 2021. This was primarily driven
by a $3.2 million increase in compensation expenses, mainly as a result of increased headcount, a $0.5 million increase in travel expenses,
a $0.4 million increase in non-cash stock-based compensation expense, a $0.3 million increase in marketing and advertising expenses associated
with the commercialization of Barostim in the U.S., and a $0.2 million increase in professional fees.
Other income, net was $0.3 million for the three months ended September 30,
2022, compared to $1.8 million for the three months ended September 30, 2021. The income in the third quarter of 2021 reflects $1.5
million of income related to the change in the fair value of our convertible preferred stock warrants from June 30, 2021 to July 2,
2021, which is the date the warrants converted to common stock warrants. 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 income, net.
Net loss was $9.8 million, or $0.48 per share, for the three months
ended September 30, 2022, compared to a net loss of $6.1 million, or $0.30 per share, for the three months ended September 30,
2021. Net loss per share was based on 20.6 million and 20.1 million weighted average shares outstanding for the third quarter of 2022
and 2021, respectively.
At the end of the current quarter, cash and cash equivalents were $110.0
million. Net cash used in operating and investing activities was $11.4 million for the current quarter, compared to $9.4 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.
BeAT-HF Clinical Trial Update
The Company recently reached the required 320th event of
the BeAT-HF clinical trial, which is designed to demonstrate the mortality and morbidity benefit of Barostim in the heart failure patient
population with reduced ejection fraction. The Company is still blinded to the results, and is working to ensure all event data is collected
and analyzed. The Company expects to be able to share data during the first half of 2023.
For the full year of 2022, the Company now expects:
For the fourth quarter of 2022, the Company expects to report total
revenue between $6.5 million and $7.0 million.
On October 31, 2022, the Company entered into a term loan agreement
with Innovatus Capital Partners. The new term loan provides up to $50 million of non-dilutive capital with an interest rate equal to the
greater of 8.15% or prime plus 2.65% and a final payment fee of 4.5% of the funded loan amount. The interest only period is 5 years followed
by a 3-month repayment period. The facility is set up in three tranches. On October 31, the Company borrowed the minimum amount of
$7.5 million. The Company has the option to draw down the remaining $7.5 million of Tranche A from the filing date of the 2022 10-K until
September 30, 2023. Tranche B allows the Company to draw up to $30.0 million less the Tranche A funded amount between September 1,
2023 and December 15, 2023 if the Company achieves trailing three months revenue of $5.75 million prior to June 30, 2023. Tranche
C allows the Company to draw up to $20.0 million between September 1, 2024 and December 15, 2024 if the Company achieves trailing
three months revenue of $9.0 million prior to June 30, 2024. There is a performance covenant that will take effect at the earlier
of September 30, 2025 or the Tranche C funding date. The covenant requires the Company to achieve 50% of the trailing 12-month revenue
target set in the most recent Board approved plan. The term loans are secured by substantially all of the Company's assets.
Webcast and Conference Call Information
Company will host a conference call at 5:30 pm Eastern Time on Tuesday, November 1st, 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/8kfcmjvb.
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.
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 fourth 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