Full Press Release Details
CVRx Reports Third Quarter 2024 Financial and
MINNEAPOLIS, Oct. 29, 2024 (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 third quarter of 2024.
"We're thrilled with our continued strong performance in the
third quarter, which reflects the growing adoption of Barostim therapy and the dedication of our team," said Kevin Hykes, President
and Chief Executive Officer of CVRx. "The recent favorable news regarding inpatient reimbursement and the Category 1 code, coupled
with new long-term data demonstrating Barostim's durable quality of life benefits, strengthens our position in the market. We remain
focused on improving patient access, increasing education and awareness, and expanding our clinical evidence base. These developments,
along with our strengthened leadership team and stabilized sales force reinforce our confidence in Barostim's potential to become standard
of care for patients suffering from the debilitating symptoms of heart failure."
Third Quarter 2024 Financial and Operating Results
Revenue was $13.4 million for the three months ended September 30,
2024, an increase of $2.9 million, or 27%, over the three months ended September 30, 2023.
Revenue generated in the U.S. was $12.3 million for the three months
ended September 30, 2024, an increase of $2.7 million, or 28%, over the three months ended September 30, 2023. HF revenue units
in the U.S. totaled 391 and 303 for the three months ended September 30, 2024 and 2023, respectively. HF revenue in the U.S. totaled
$12.2 million and $9.4 million for the three months ended September 30, 2024 and 2023, respectively. The increases were 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 September 30, 2024, the Company had a total of 208 active
implanting centers in the U.S., as compared to 189 as of June 30, 2024. 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
45 during the three months ended September 30, 2024.
Revenue generated in Europe was $1.1 million for the three months ended
September 30, 2024, a nominal increase compared to the three months ended September 30, 2023. Total revenue units in Europe
increased to 56 for the three months ended September 30, 2024 from 47 in the prior year period. The number of sales territories in
Europe remained consistent at six for the three months ended September 30, 2024.
Gross profit was $11.1 million for the three months ended September 30,
2024, an increase of $2.3 million, or 26%, over the three months ended September 30, 2023. Gross margin was 83% and 84% for the three
months ended September 30, 2024 and September 30, 2023, respectively.
R&D expenses decreased $0.2 million, or 7%, to $2.5 million for
the three months ended September 30, 2024 compared to the three months ended September 30, 2023, driven by a decrease in consulting
SG&A expenses increased $6.0 million, or 38%, to $21.6 million
for the three months ended September 30, 2024 compared to the three months ended September 30, 2023. This change was primarily
driven by a $3.7 million increase in compensation expenses, mainly as a result of increased headcount, a $1.1 million increase in non-cash
stock-based compensation expense, a $0.5 million increase in travel expenses, and a $0.4 million increase in advertising expenses.
Interest expense increased $0.5 million for the three months ended
September 30, 2024, compared to the three months ended September 30, 2023, driven by the increased borrowings under the term
loan agreement with Innovatus Capital Partners.
Other income, net decreased $0.1 million for the three months ended
September 30, 2024, compared to the three months ended September 30, 2023. This decrease was primarily driven by less interest
income on our interest-bearing accounts.
Net loss was $13.1 million, or $0.57 per share, for the three months
ended September 30, 2024, compared to a net loss of $9.0 million, or $0.43 per share, for the three months ended September 30,
2023. Net loss per share was based on 22.8 million weighted average shares outstanding for three months ended September 30, 2024
and 20.8 million weighted average shares outstanding for the three months ended September 30, 2023.
As of September 30, 2024, cash and cash equivalents were $100.2
million. Net cash used in operating and investing activities was $10.4 million for the three months ended September 30, 2024 as compared
to $10.2 million for the three months ended June 30, 2024.
September 30, 2024, the Company borrowed the remaining $20.0 million under the third and final tranche of the Innovatus loan agreement,
such that the outstanding principal balance is $50.0 million.
the three months ended September 30, 2024, the Company issued 2,358,775 shares of common stock for gross proceeds of $20.3
million under its at-the-market offering.
Final Inpatient Prospective Payment System Rule
In August 2024, the Company announced that the Centers for Medicare
and Medicaid Services (CMS) has reassigned the Barostim implant procedure for the inpatient setting as part of the Medicare Hospital Inpatient
Prospective Payment System (IPPS) final rule for CMS' Fiscal Year 2025, which began on October 1, 2024. On that date,
Barostim was reassigned to MS-DRG 276, which carries a national average payment of approximately $43,000, a significant increase from
the previous payment range of $17,000-$23,000, which is expected to facilitate increased access to the therapy for patients with heart
AMA Approves Category I CPT Codes for Barostim Therapy
The American Medical Association's CPT Editorial Panel approved new
Category I codes for Barostim therapy, effective January 1, 2026. Led by the Society for Vascular Surgery with support from the American
College of Cardiology, this advancement from Category III to Category I status reflects Barostim's growing adoption and established clinical
evidence in treating heart failure symptoms. The new designation is expected to streamline reimbursement processes and expand access to
this important therapy for heart failure patients.
Long-term Quality of Life Benefits of Barostim
In September 2024, the Company announced the publication of new
data in the Journal of the American College of Cardiology: Heart Failure, detailing the durable improvements in Barostim patients out
to 24-months in quality of life measures. The data demonstrated that patients receiving Barostim plus guideline-directed medical therapy
reported feeling significantly better in a variety of physical and psychosocial measures compared to patients who received guideline-directed
medical therapy alone. This publication builds on the data from the BeAT-HF trial published in 2024 in the European Journal of Heart Failure
demonstrating the long-term sustained symptomatic benefits of Barostim in heart failure patients with reduced ejection fraction.
For the full year of 2024, the Company expects:
For the fourth quarter of 2024, the Company expects to report total
revenue between $14.5 million and $15.5 million.
Webcast and Conference Call Information
The Company will host a conference call to review its results at 4:30
p.m. Eastern Time today. A live webcast of the investor conference call will be available online at the investor relations page of
the Company's website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-877-704-4453 for U.S. callers,
or 1-201-389-0920 for international callers, approximately ten minutes prior to the start time.
is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions
for patients with cardiovascular diseases. Barostim is 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. 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 future financial performance (including our financial guidance regarding full year and
fourth quarter 2024 results), our anticipated growth strategies, anticipated trends in our industry, our business prospects and our opportunities. 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