Full Press Release Details
CVRx Reports Second Quarter 2025 Financial and Operating Results
MINNEAPOLIS, August 4, 2025 (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 second quarter of 2025.
"We delivered solid second
quarter results and continued to build momentum across our business," said Kevin Hykes, President and Chief Executive Officer of
CVRx. "Our sales force transformation is gaining traction, and we're building sustainable Barostim programs with high potential centers.
We continue to make progress on multiple fronts by advancing our clinical evidence strategy and strengthening our reimbursement position,
including CMS' proposal to keep Barostim in APC 1580 with appropriate payment for the implant procedure. The fundamentals of our business
remain strong, and our maturing commercial organization positions us well for continued growth."
Second Quarter 2025 Financial
and Operating Results
Revenue was $13.6 million
for the three months ended June 30, 2025, an increase of $1.8 million, or 15%, over the three months ended June 30, 2024.
Revenue generated in the U.S.
was $12.2 million for the three months ended June 30, 2025, an increase of $1.6 million, or 15%, over the three months ended June 30,
2024. HF revenue in the U.S. totaled $12.1 million and $10.5 million for the three months ended June 30, 2025 and 2024, respectively.
HF revenue units in the U.S. totaled 387 and 339 for the three months ended June 30, 2025 and 2024, 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 June 30, 2025,
the Company had a total of 240 active implanting centers in the U.S., compared to 227 as of March 31, 2025. 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 47 during the three months ended June 30, 2025.
Revenue generated in Europe
was $1.3 million for the three months ended June 30, 2025, an increase of $0.2 million, or 19%, over the three months ended June 30,
2024. Total revenue units in Europe decreased to 61 for the three months ended June 30, 2025, compared to 63 in the prior year period.
The number of sales territories in Europe remained consistent at five for the three months ended June 30, 2025.
Gross profit was $11.5 million
for the three months ended June 30, 2025, an increase of $1.5 million, or 16%, over the three months ended June 30, 2024. Gross
margin was 84% for each of the three months ended June 30, 2025 and 2024.
R&D expenses decreased
$0.3 million, or 11%, to $2.5 million for the three months ended June 30, 2025, compared to the three months ended June 30,
2024. This change was driven by a $0.3 million decrease in compensation expenses.
SG&A expenses increased
$2.2 million, or 11%, to $23.4 million for the three months ended June 30, 2025, compared to the three months ended June 30,
2024. This change was primarily driven by a $1.4 million increase in compensation expenses, a $0.8 million increase in travel expenses,
and a $0.4 million increase in non-cash stock-based compensation expense, partially offset by a $0.5 million decrease in advertising expenses.
Interest expense increased
$0.5 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024. This increase was driven
by the interest expense on higher levels of borrowings under the term loan agreement with Innovatus Capital Partners.
Other income, net increased
$0.2 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024. This increase was primarily
driven by more interest income on our interest-bearing accounts.
Net loss was $14.7 million,
or $0.57 per share, for the three months ended June 30, 2025, compared to a net loss of $14.0 million, or $0.65 per share, for the
three months ended June 30, 2024. Net loss per share was based on 26.1 million weighted average shares outstanding for three months
ended June 30, 2025 and 21.6 million weighted average shares outstanding for the three months ended June 30, 2024.
As of June 30, 2025,
cash and cash equivalents were $95.0 million. Net cash used in operating and investing activities was $8.0 million for the three months
ended June 30, 2025 compared to $10.2 million for the three months ended June 30, 2024.
Reimbursement Updates
2026 OPPS Rule Progress:
CMS has proposed to keep the Barostim implant procedure as part of the New Technology Ambulatory Payment Classification (APC) 1580 for
2026, with an associated payment of approximately $45,000 for procedures performed in the outpatient setting. CMS is also soliciting comments
about the need for a Level 6 Neurostimulator APC. CVRx expects CMS to publish the 2026 Medicare Hospital Outpatient Prospective Payment
System (OPPS) final rule in November, which is expected to take effect on January 1, 2026.
Category I CPT Codes:
The transition to Category I CPT codes in January 2026 represents a significant milestone that will directly benefit commercial efforts.
The proposed Medicare Physician Fee Schedule, released July 15, specified 11 relative value units (RVUs) for the implant procedure,
translating to a national average physician payment of approximately $550, consistent with the Company's expectations. Overall,
the transition to Category I will eliminate the automatic denials regularly seen with Category III codes and improve prior authorization
predictability to fairly pay physicians for the procedure. This proposal is also expected to be finalized in November.
Chief Operating Officer
CVRx is pleased to announce
that Brent Binkowski will join as Chief Operating Officer in August, and will be responsible for the research and development, operations,
regulatory affairs and quality functions. Binkowski brings over 20 years of leadership experience in medical devices, with expertise in
implantable devices covering interventional cardiology, radiology, and urology. His experience building world-class teams and scaling
businesses will be of great value to the Company.
For the full year of 2025,
the Company narrowed its revenue and operating expense guidance ranges and now expects:
For the third quarter of 2025,
the Company expects to report total revenue between $13.7 million and $14.7 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 1-800-445-7795 for U.S. callers, or 1-785-424-1699 for international callers, approximately ten minutes prior to the start time.
Please reference the following conference ID to access the call: CVRXQ225.
CVRx 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 been certified as compliant with the EU Medical
Device Regulation (MDR) and holds CE Mark approval 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
third quarter 2025 results), our anticipated growth strategies (including statements about the proposal to maintain the APC for the Barostim
implant procedure and progress toward expanded access to Barostim), 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