Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see
General Instruction A.2. below):
Indicate by check mark whether the registrant is
an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
On February 12, 2026, CVRx, Inc. issued a
press release announcing its financial results for the fourth quarter and year ended December 31, 2025. A copy of the press release
is attached as Exhibit 99.1 and is incorporated herein by reference.
The information contained in this Item 2.02,
including Exhibit 99.1, is being furnished and shall not be deemed to be “filed” with the Securities and Exchange Commission
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to
the liabilities of that section and is not incorporated by reference into any filing under the Securities Act of 1933, as amended, or
the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such a filing.
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Exhibit 99.1
CVRx Reports Fourth Quarter and Full
Year 2025 Financial and Operating Results
MINNEAPOLIS,
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.
Recent Highlights
| · | 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 |
"We
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."
Fourth
Quarter 2025 Financial and Operating Results
Revenue
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
December 31, 2024.
Revenue
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.
As
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.
Revenue
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
December 31, 2025.
Gross
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.
R&D
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.
SG&A
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.
Interest
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
Partners.
Other
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,
2024.
Full
Year 2025 Financial and Operating Results
Revenue
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,
2024.
Revenue
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,
respectively.
As
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.
Revenue
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.
Gross
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.
R&D
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.
SG&A
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.
Interest
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.
Other
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.
Net
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.
As
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.
BENEFIT-HF
Clinical Trial
In
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.
Debt
Facility
On
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.
Business
Outlook
For
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. |
For
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
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.
About CVRx, Inc.
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 first quarter 2026 results), our anticipated growth strategies (including statements regarding the expected timing,
enrollment, scope and outcomes of the BENEFIT-HF clinical trial, potential expansion of the Barostim indication, and anticipated benefits
of Barostim therapy), 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 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 release and are subject to a number of known and unknown risks, uncertainties and assumptions, including,
but not limited to, our expectations regarding enrollment in BENEFIT-HF and the resulting impact on our addressable market; our history
of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single
product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to continue demonstrating to physicians
and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use
of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier
to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third-party manufacturers
and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S.
or worldwide; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time
consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption
and regulatory approvals resulting from additional long-term clinical data about our product; and other important factors that could
cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A.
Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and “Part II, Item
1A. Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, as such factors may
be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law,
we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information,
future events, changed circumstances or otherwise.
Investor Contact:
Mark Klausner or Mike Vallie
ICR Healthcare
443-213-0501
ir@cvrx.com
Media Contact:
Emily Meyers
CVRx, Inc.
763-416-2853
emeyers@cvrx.com
CVRx, INC.
Consolidated
Balance Sheets
(In thousands,
except share and per share data)
| | |
| | |
| |
| | |
December 31, | | |
December 31, | |
| | |
2025 | | |
2024 | |
| Assets | |
| | | |
| | |
| Current assets: | |
| | | |
| | |
| Cash
and cash equivalents | |
$ | 75,708 | | |
$ | 105,933 | |
| Accounts
receivable, net of allowances of $871 and $780, respectively | |
| 10,665 | | |
| 9,268 | |
| Inventory | |
| 12,205 | | |
| 12,107 | |
| Prepaid
expenses and other current assets | |
| 3,069 | | |
| 2,505 | |
| Total
current assets | |
| 101,647 | | |
| 129,813 | |
| Property and equipment, net | |
| 2,243 | | |
| 2,505 | |
| Operating lease right-of-use
asset | |
| 878 | | |
| 1,069 | |
| Other non-current
assets | |
| 26 | | |
| 27 | |
| Total
assets | |
$ | 104,794 | | |
$ | 133,414 | |
| Liabilities and Stockholders’
Equity | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts
payable | |
$ | 3,833 | | |
$ | 2,582 | |
| Accrued
expenses | |
| 9,484 | | |
| 8,180 | |
| Total
current liabilities | |
| 13,317 | | |
| 10,762 | |
| Long-term debt | |
| 49,514 | | |
| 49,273 | |
| Operating lease liability, non-current
portion | |
| 638 | | |
| 877 | |
| Other long-term
liabilities | |
| 2,001 | | |
| 1,447 | |
| Total
liabilities | |
| 65,470 | | |
| 62,359 | |
| Commitments and contingencies | |
| | | |
| | |
| Stockholders’ equity: | |
| | | |
| | |
| Common stock, $0.01 par value, 200,000,000 authorized
as of December 31, 2025 and 2024; 26,311,607 and 25,324,684 shares issued and outstanding as of December 31, 2025
and 2024, respectively | |
| 263 | | |
| 253 | |
| Additional paid-in capital | |
| 629,916 | | |
| 608,354 | |
| Accumulated deficit | |
| (590,652 | ) | |
| (537,346 | ) |
| Accumulated
other comprehensive loss | |
| (203 | ) | |
| (206 | ) |
| Total
stockholders’ equity | |
| 39,324 | | |
| 71,055 | |
| Total
liabilities and stockholders’ equity | |
$ | 104,794 | | |
$ | 133,414 | |
CVRx, INC.
Consolidated
Statements of Operations and Comprehensive Loss
(In thousands,
except share and per share data)
| | |
| | |
| | |
| | |
| |
| | |
Three months
ended | | |
Year ended | |
| | |
December 31, | | |
December 31, | |
| | |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| Revenue | |
$ | 16,024 | | |
$ | 15,342 | | |
$ | 56,651 | | |
$ | 51,292 | |
| Cost of
goods sold | |
| 2,199 | | |
| 2,571 | | |
| 8,311 | | |
| 8,334 | |
| Gross
profit | |
| 13,825 | | |
| 12,771 | | |
| 48,340 | | |
| 42,958 | |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research
and development | |
| 3,000 | | |
| 2,805 | | |
| 11,132 | | |
| 11,131 | |
| Selling,
general and administrative | |
| 22,009 | | |
| 20,240 | | |
| 88,473 | | |
| 91,317 | |
| Total
operating expenses | |
| 25,009 | | |
| 23,045 | | |
| 99,605 | | |
| 102,448 | |
| Loss from
operations | |
| (11,184 | ) | |
| (10,274 | ) | |
| (51,265 | ) | |
| (59,490 | ) |
| Interest expense | |
| (1,417 | ) | |
| (1,520 | ) | |
| (5,827 | ) | |
| (4,397 | ) |
| Other income,
net | |
| 660 | | |
| 1,072 | | |
| 3,768 | | |
| 3,977 | |
| Loss before
income taxes | |
| (11,941 | ) | |
| (10,722 | ) | |
| (53,324 | ) | |
| (59,910 | ) |
| Benefit
(provision) for income taxes | |
| 7 | | |
| 71 | | |
| 18 | | |
| (55 | ) |
| Net loss | |
| (11,934 | ) | |
| (10,651 | ) | |
| (53,306 | ) | |
| (59,965 | ) |
| Cumulative
translation adjustment | |
| - | | |
| 2 | | |
| 2 | | |
| 1 | |
| Comprehensive
loss | |
$ | (11,934 | ) | |
$ | (10,649 | ) | |
$ | (53,304 | ) | |
$ | (59,964 | ) |
| Net loss per share, basic and
diluted | |
$ | (0.46 | ) | |
$ | (0.43 | ) | |
$ | (2.04 | ) | |
$ | (2.65 | ) |
| Weighted-average common shares
used to compute net loss per share, basic and diluted | |
| 26,218,215 | | |
| 24,715,681 | | |
| 26,084,709 | | |
| 22,596,229 | |
