Full Press Release Details
CVRx Reports Second Quarter 2021 Financial and
Second Quarter 2021 Revenue of $3.1 million,
a 150% Increase Over Prior Year
MINNEAPOLIS, August 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 second quarter of 2021.
"We are extremely pleased
with our continued strong financial and operational performance during the quarter. We delivered topline growth of 150%, driven by a significant
increase in the number of active implanting centers added in recent quarters, as well as the accelerated utilization of Barostim by existing
customers. These results demonstrate the strong and growing adoption of Barostim by physicians and patients as a solution for heart failure,"
said Nadim Yared, President and Chief Executive Officer of CVRx. "Looking forward, we
are focused on driving growth by increasing patient flow at existing implanting centers, as well as increasing the number of new active
implanting centers. To accomplish this, we will continue to invest to expand our commercial infrastructure and increase awareness of this
life changing technology among physicians and patients. The closing of our IPO in July provides us with incremental capital to fuel
that expansion and accelerate the adoption of Barostim."
Second Quarter 2021 Financial and Operating Results
| Revenue by Geography | ||||||||||||
| Three months ended June 30, | ||||||||||||
| 2021 | 2020 | |||||||||||
| Amount | Amount | % Change | ||||||||||
| (dollars in thousands) | ||||||||||||
| United States | $ | 2,105 | $ | 197 | 969 | % | ||||||
| Europe | 1,018 | 1,053 | (3 | )% | ||||||||
| Total Revenue | $ | 3,123 | $ | 1,250 | 150 | % |
| United States Revenue by Product Category | ||||||||||||
| Three months ended June 30, | ||||||||||||
| 2021 | 2020 | |||||||||||
| Amount | Amount | % Change | ||||||||||
| (dollars in thousands) | ||||||||||||
| U.S. Heart Failure (HF) | $ | 2,001 | $ | 65 | NM | |||||||
| U.S. Legacy Hypertension | 104 | 132 | (21 | )% | ||||||||
| Total U.S. Revenue | $ | 2,105 | $ | 197 | 969 | % |
Revenue increased by $1.9 million, or 150%, to $3.1 million for the
three months ended June 30, 2021 compared to the three months ended June 30, 2020.
generated in the U.S. was $2.1 million for the three months ended June 30, 2021, an increase of $1.9 million, or 969%, over the three
months ended June 30, 2020. HF revenue units in the U.S. totaled 67 and 2 for the three months ended June 30, 2021 and 2020,
respectively. HF revenue in the U.S. totaled $2.0 million and $65,000 for the three months ended June 30, 2021 and 2020, respectively.
The increase was primarily driven by continued growth following the commercial launch in 2020, which resulted in the expansion
into new sales territories and increased physician and patient awareness of Barostim. As of June 30, 2021, the Company had a total
of 31 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. The number of sales territories in the U.S. increased by two to a total of eight
during the three months ended June 30, 2021.
generated in Europe was $1.0 million for the three months ended June 30, 2021, a decrease of $35,000, or 3.3%, over the three months
ended June 30, 2020. Total revenue units in Europe decreased to 47 from 49 for the three months ended June 30, 2021 and 2020,
respectively. The revenue decrease was primarily due to the impact of the COVID-19 pandemic. The number of sales territories in
Europe remained consistent at six during the three months ended June 30, 2021.
profit was $2.2 million for the three months ended June 30, 2021, an increase of $1.3 million, or 144%, over the three months ended
June 30, 2020. Gross margin decreased to 70.8% for the three months ended June 30, 2021 compared to 72.4% for the three months
ended June 30, 2020. Gross margin for the three months ended June 30, 2021 was lower due to a larger percentage of our
revenue units coming from full systems, which require an 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 $0.1 million, or 5.8%, to $2.3 million for
the three months ended June 30, 2021 compared to the three months ended June 30, 2020. This change was primarily due to an increase
in stock-based compensation expense from $0.01 million to $0.19 million for the three months ended June 30, 2020 and 2021, respectively.
SG&A expenses increased $3.8 million, or 207%, to $5.6 million
for the three months ended June 30, 2021 compared to the three months ended June 30, 2020. The primary driver was an increase
in compensation, including salaries and commissions, and other employee-related expenses, mainly as a result of increased headcount. In
addition, stock-based compensation expense increased from $0.02 million to $0.43 million for the three months ended June 30, 2020
and 2021, respectively.
Other expense, net was $11.4 million for the three months ended June 30,
2021 compared to income of $0.03 for the three months ended June 30, 2020. This change was primarily driven by an $11.4 million increase
in expense related to the increase in fair value of the Company's convertible preferred stock warrants.
Net loss was $17.7 million, or $48.48 per share, for the three months
ended June 30, 2021, compared to a net loss of $3.7 million, or $10.18 per share, for the three months ended June 30, 2020.
Net loss per share was based on 366,066 and 360,238 weighted average shares outstanding for the second quarter of 2021 and 2020, respectively.
As of June 30, 2021, cash and cash equivalents were $47.1 million
compared to $54.0 million as of March 31, 2021. Net cash used in operating and investing activities were $6.8 million for the three
months ended June 30, 2021.
For the full year of 2021, the Company expects:
For the third quarter of 2021, the Company expects to report total
revenue between $3.3 million and $3.6 million.
Initial Public Stock Offering
On July 2, 2021, the Company closed its IPO of 8,050,000 shares
of its common stock at a public offering price of $18.00 per share, which included 1,050,000 shares of common stock issued upon the exercise
in full by the underwriters of their option to purchase additional shares, for net proceeds from the offering, after deducting the underwriting
discount and other offering expenses payable by CVRx, of approximately $133.3 million.
In connection with the IPO, on June 22, 2021, the Company effected
a 1-for-39.548 reverse stock split of the Company's common stock. Accordingly, all share and per-share amounts for all periods presented
in this release, including the financial statements below, have been adjusted retroactively to reflect the reverse stock split.
The table below presents the Company's balance sheet data as
of June 30, 2021 on an actual basis and on a pro forma as adjusted basis to give effect to:
| As of June 30, 2021 | ||||||||
| Actual | Pro forma as adjusted | |||||||
| (in thousands, except share data) | ||||||||
| Cash and cash equivalents | $ | 47,128 | $ | 180,385 | ||||
| Convertible preferred stock warrant liability | 19,051 | - | ||||||
| Redeemable convertible preferred stock | 329,983 | - | ||||||
| Total stockholders' equity (deficit) | $ | (318,931 | ) | $ | 163,360 | |||
| Shares of common stock outstanding | 366,342 | 20,345,926 |
Board of Directors Appointment
On July 12, 2021, the Company announced the appointment of Martha
Shadan to its Board of Directors. With more than three decades of experience as a business leader in the life science industry, Ms. Shadan
brings a long track record of success in helping to commercialize medical technology innovations for both start-up and large companies.
Ms. Shadan currently serves as the president and CEO of Miach Orthopaedics, a developer of bioengineered surgical implants for connective
First Clinical Procedure with BATwire
In June 2021, the first BATwire procedure was performed in the
U.S. as part of a clinical trial. BATwire is a new implant toolkit which enables an ultrasound-guided implant procedure of Barostim. The
Company believes BATwire could potentially expand the Company's addressable patient population by including those who are deemed
clinically unfit for the current procedure. In addition, as a result of this simplified implantation process, the Company believes more
physicians, including electrophysiologists, would be confident and comfortable implanting Barostim.
Webcast and Conference Call Information
Company will host a conference call at 5:30 pm Eastern Time on August 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 1659235. To listen to a live
webcast, please visit the Investors section of the CVRx website at: https://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 third quarter and full year 2021 results and expectations
about 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,"