Full Press Release Details
CVRx Reports Fourth Quarter and Full
Year 2025 Financial and Operating Results
Feb. 12, 2026 (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 fourth quarter and full year of 2025.
| Total revenue for the fourth quarter 2025 was $16.0 million, an increase of 4% over the prior year quarter | ||
| U.S. revenue for the fourth quarter of 2025 was $14.9 million, an increase of 4% over the prior year quarter | ||
| Total revenue for 2025 was $56.7 million, an increase of 10% over the prior year | ||
| Active implanting centers in the U.S. grew to 252 in 2025, as compared to 223 in the prior year | ||
| Initiated the BENEFIT-HF trial with first enrollments expected in the second quarter of 2026 | ||
| Category I CPT codes and the related favorable physician fee payment levels took effect on Jan. 1, 2026 |
achieved key foundational goals in 2025, and we're heading into 2026 with increasing momentum. Our sales team is building experience
and becoming more effective, and we're seeing strong support at high-potential centers. Additionally, the new Category I CPT codes, effective
January 1st, remove automatic prior authorization denials. Finally, the initiation of the landmark BENEFIT-HF trial under CMS Category
B IDE coverage is a major step that could allow us to triple our addressable market," said Kevin Hykes, President and Chief Executive
Officer of CVRx. "We're confident that these developments will support our accelerated growth and make Barostim therapy more
accessible for heart failure patients in the coming year."
Quarter 2025 Financial and Operating Results
was $16.0 million for the three months ended December 31, 2025, an increase of $0.7 million, or 4%, over the three months ended
generated in the U.S. was $14.9 million for the three months ended December 31, 2025, an increase of $0.6 million, or 4%, over the
three months ended December 31, 2024. Revenue units in the U.S. totaled 478 and 460 for the three months ended December 31,
2025 and 2024, respectively. 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.
of December 31, 2025, the Company had a total of 252 active implanting centers, as compared to 250 as of September 30, 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 three to a total of 53 during the three months ended December 31, 2025.
generated in Europe was $1.1 million for the three months ended December 31, 2025, an increase of $0.1 million, or 10%, over the
three months ended December 31, 2024. Total revenue units in Europe increased to 49 for the three months ended December 31,
2025 from 41 in the prior year period. The number of sales territories in Europe remained consistent at five for the three months ended
profit was $13.8 million for the three months ended December 31, 2025, an increase of $1.1 million, or 8%, over the three months
ended December 31, 2024. Gross margin increased to 86% for the three months ended December 31, 2025, compared to 83% for the
three months ended December 31, 2024. Gross margin for the three months ended December 31, 2025 was higher due to an increase
in the average selling price and a decrease in the cost per unit, primarily resulting from an increase in manufacturing efficiencies.
expenses increased $0.2 million, or 7%, to $3.0 million for the three months ended December 31, 2025 compared to the three months
ended December 31, 2024. This change was primarily driven by a $0.3 million increase in compensation expenses, mainly as a result
of increased headcount, partially offset by a $0.1 million decrease in clinical study expenses.
expenses increased $1.8 million, or 9%, to $22.0 million for the three months ended December 31, 2025 compared to the three months
ended December 31, 2024. This change was driven by a $1.3 million increase in compensation expenses, mainly as a result of increased
headcount, a $0.5 million increase in advertising expense, and a $0.3 million increase in travel expense, partially offset by a $0.3
million decrease in consulting expense.
expense decreased $0.1 million to $1.4 million for the three months ended December 31, 2025 compared to the three months ended December 31,
2024. This decrease was driven by the lower interest rate on the levels of borrowings under the term loan agreement with Innovatus Capital
income, net was $0.7 million for the three months ended December 31, 2025, compared to $1.1 million for the three months ended December 31,
2024. This decrease was primarily driven by less interest income on our interest-bearing accounts.
Net loss was $11.9 million,
or $0.46 per share, for the three months ended December 31, 2025, compared to a net loss of $10.7 million, or $0.43 per share, for
the three months ended December 31, 2024. Net loss per share was based on 26.2 million weighted average shares outstanding for three
months ended December 31, 2025 and 24.7 million weighted average shares outstanding for the three months ended December 31,
Year 2025 Financial and Operating Results
was $56.7 million for the year ended December 31, 2025, an increase of $5.4 million, or 10%, over the year ended December 31,
generated in the U.S. was $51.9 million for the year ended December 31, 2025, an increase of $4.7 million, or 10%, over the year
ended December 31, 2024. Revenue units in the U.S. totaled 1,648 and 1,522 for the years ended December 31, 2025 and 2024,
of December 31, 2025, the Company had a total of 252 active implanting centers, as compared to 223 as of December 31, 2024.
As of December 31, 2025, we had 53 sales territories in the U.S. as compared to 48 sales territories as of December 31, 2024.
generated in Europe was $4.8 million for the year ended December 31, 2025, an increase of $0.6 million, or 16%, over the year ended
December 31, 2024. Total revenue units in Europe increased to 219 for the year ended December 31, 2025, from 204 for the prior
year period. The number of sales territories in Europe remained consistent at five for each of the years ended December 31, 2025
and December 31, 2024.
profit was $48.3 million for the year ended December 31, 2025, an increase of $5.4 million, or 13%, over the year ended December 31,
2024. Gross margin increased to 85% for the year ended December 31, 2025 compared to 84% for the year ended December 31, 2024.
Gross margin for the year ended December 31, 2025 was higher due to an increase in the average selling price and a decrease in the
cost per unit, primarily due to an increase in manufacturing efficiencies.
expenses were $11.1 million for the years ended December 31, 2025 and December 31, 2024, respectively. R&D expense for
the year ended December 31, 2025 included a $0.4 million increase in compensation expenses, mainly as a result of increased headcount,
offset by a $0.5 million decrease in clinical study expenses.
expenses decreased $2.8 million, or 3%, to $88.5 million for the year ended December 31, 2025, compared to the year ended December 31,
2024. This change was driven by a $7.9 million decrease in non-cash stock-based compensation expense, a $0.2 million decrease in insurance
expenses, and a $0.2 million decrease in bad debt expense, partially offset by a $4.0 million increase in compensation expenses, mainly
as a result of increased headcount and a $1.5 million increase in travel expenses. Approximately $8.4 million of the decrease in non-cash
stock-based compensation expense is related to the modification of stock options held by our former Chief Executive Officer in connection
with his retirement in the first quarter of 2024.
expense increased $1.4 million to $5.8 million for the year ended December 31, 2025, compared to the year ended December 31,
2024. This increase was driven by the interest expense on borrowings under the term loan agreement with Innovatus Capital Partners.
income, net was $3.8 million for the year ended December 31, 2025, compared to $4.0 million for the year ended December 31,
2024. This decrease was primarily driven by less interest income on our interest-bearing accounts.
loss was $53.3 million, or $2.04 per share, for the year ended December 31, 2025, compared to a net loss of $60.0 million, or $2.65
per share, for the year ended December 31, 2024. Net loss per share was based on 26.1 million weighted average shares outstanding
for year ended December 31, 2025 and 22.6 million weighted average shares outstanding for the year ended December 31, 2024.
of December 31, 2025, cash and cash equivalents were $75.7 million. Net cash used in operating and investing activities was $40.8
million for the year ended December 31, 2025, compared to $40.5 million for the year ended December 31, 2024.
January 2026, the Company announced the initiation of the BENEFIT-HF trial, a landmark randomized controlled trial designed to evaluate
Barostim's impact on all-cause mortality and heart failure decompensation events in an expanded population of heart failure patients
with left ventricular ejection fractions up to 50% and NT-proBNP levels up to 5,000 pg/mL. If successful, the BENEFIT-HF trial could
expand the indicated patient population for Barostim approximately three times, significantly broadening access to this proven neuromodulation-based
approach to heart failure management. The trial is expected to be one of the largest therapeutic cardiac device trials ever performed
in heart failure, randomizing 2,500 patients at approximately 150 centers across the U.S. and Germany. The Centers for Medicare &
Medicaid Services ("CMS") has approved Category B IDE coverage for the trial, and enrollment is expected to begin in the second
quarter of 2026. The net trial costs are expected to be $20 million to $30 million spread over the next five to seven years.
January 9, 2026, the Company amended its term loan agreement with an affiliate of Innovatus Capital Partners, LLC, to increase the
existing facility by $50 million, to an aggregate principal amount of up to $100 million, subject to the Company's achievement
of certain milestones. Also on the closing date, the Company borrowed an additional $10 million under the term loan agreement, bringing
the total outstanding principal amount of term loans to $60 million. The initial interest rate under the amended term loan agreement
is equal to the greater of 9.40% or prime plus 2.65%. The interest-only period is extended four years from the closing date and is extendable
to five years from the closing date upon achieving certain revenue milestones. The term loans mature in May 2031 and continue to
be secured by substantially all of the Company's assets.
the full year of 2026, the Company continues to expect:
| Total revenue between $63.0 million and $67.0 million; | ||
| Gross margin between 84% and 86%; | ||
| Operating expenses between $103.0 million and $107.0 million. |
the first quarter of 2026, the Company expects to report total revenue between $13.7 million and $14.7 million.
Webcast and Conference Call Information
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.
CVRx is a commercial-stage medical device
company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular