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 August 6, 2026, CVRx, Inc. issued a press
release announcing its financial results for the second quarter ended June 30, 2026. 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 Second Quarter 2026
Financial and Operating Results
MINNEAPOLIS,
August 6, 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 second quarter of 2026.
Recent Highlights
| · | Total
revenue for the second quarter of 2026 was $15.7 million, an increase of approximately 16%
over the prior year quarter |
| · | U.S.
revenue for the second quarter of 2026 was $14.8 million, an increase of 21% over the prior
year quarter |
| · | Active
implanting centers in the U.S. grew to 258 as of June 30, 2026, as compared to 240 as
of June 30, 2025 |
| · | Humana
issued a Medicare Advantage coverage policy, effective May 1, 2026 for Barostim therapy,
which is the first coverage policy of its kind for Barostim |
"We are
pleased with the strong revenue growth and margin performance in the second quarter along with the
reimbursement progress we made, including the new Medicare Advantage coverage policy from Humana. However, we are not satisfied with
our updated outlook for the balance of the year, driven by fewer sales territories than anticipated, lower sales force productivity and
a prolonged challenge with one of our largest payers,” said Kevin Hykes, President and Chief Executive
Officer of CVRx. “We are taking direct action to address these headwinds, and our confidence in the long-term fundamentals
of this business remains high, supported by strong growth observed in our most stable regions and encouraging early progress on the BENEFIT-HF
trial and our broader clinical and reimbursement strategies."
Second
Quarter 2026 Financial and Operating Results
Revenue
was $15.7 million for the three months ended June 30, 2026, an increase of $2.1 million, or 16%, over the three months ended June 30,
2025.
Revenue
generated in the U.S. was $14.8 million for the three months ended June 30, 2026, an increase of $2.5 million, or 21%, over the
three months ended June 30, 2025. Revenue units in the U.S. totaled 466 and 391 for the three months ended June 30, 2026 and
2025, 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, 2026, the Company had a total of 258 active implanting centers in the U.S., as compared to 240 as of June 30, 2025.
Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. As of June 30,
2026, the number of sales territories in the U.S. is 56 as compared to 47 sales territories as of June 30, 2025.
Revenue
generated in Europe was $0.9 million for the three months ended June 30, 2026, a decrease of $0.4 million, or 31%, compared to the
three months ended June 30, 2025. Total revenue units in Europe decreased to 40 for the three months ended June 30, 2026, from
61 in the prior year period. The number of sales territories in Europe remained consistent at five as of June 30, 2026.
Gross
profit was $13.7 million for the three months ended June 30, 2026, an increase of $2.3 million, or 20%, over the three months ended
June 30, 2025. Gross margin was 87% and 84% for the three months ended June 30, 2026 and June 30, 2025, respectively.
R&D
expenses increased $0.7 million, or 27%, to $3.1 million for the three months ended June 30, 2026, compared to the three months
ended June 30, 2025. This change was driven by a $0.6 million increase in headcount expenses and a $0.1 million increase in clinical
trial expenses.
SG&A
expenses increased $0.3 million, or 1%, to $23.6 million for the three months ended June 30, 2026, compared to the three months
ended June 30, 2025. This change was primarily driven by a $0.7 million increase in non-cash stock-based compensation expenses and
a $0.5 million increase in legal expenses, partially offset by a $0.6 million decrease in advertising expenses and a $0.3 million decrease
in travel expenses.
Interest
expense increased $0.1 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025,
driven by interest expense on the increased borrowings under the term loan agreement with Innovatus Capital Partners.
Other
income, net was $0.6 million and $1.1 million for the three months ended June 30, 2026 and 2025, respectively. These balances consisted
of interest income on our interest-bearing accounts. The decrease was primarily driven by the lower cash balance.
Net
loss was $14.0 million, or $0.53 per share, for the three months ended June 30, 2026, compared to a net loss of $14.7 million, or
$0.57 per share, for the three months ended June 30, 2025. Net loss per share was based on 26.5 million weighted average shares
outstanding for three months ended June 30, 2026 and 26.1 million weighted average shares outstanding for the three months ended
June 30, 2025.
As
of June 30, 2026, cash and cash equivalents were $64.6 million. Net cash used in operating and investing activities was $8.9 million
for the three months ended June 30, 2026, compared to $8.0 million for the three months ended June 30, 2025.
Humana
Medicare Advantage Coverage Policy
In
May 2026, Humana issued a Medicare Advantage coverage policy for Barostim therapy, effective May 1, 2026. Humana, a national
health insurance company with the second largest Medicare Advantage program in the U.S., provides coverage to approximately 5.2 million
Medicare Advantage members across 46 states. The policy covers Barostim for patients meeting its current FDA-approved indication as well
as patients enrolled in the BENEFIT-HF trial. This is now the third significant reimbursement development for Barostim this year, following
the transition to Category I CPT codes and CMS approval of Category B IDE coverage for BENEFIT-HF patients, each of which took effect
in the first quarter of 2026.
Business
Outlook
For
the full year of 2026, the Company now expects:
| · | Total
revenue between $58.0 million and $60.0 million; |
| · | Gross
margin between 86% and 87%; |
| · | Operating
expenses between $99.0 million and $101.0 million. |
For
the third quarter of 2026, the Company expects to report total revenue between $13.5 million and $14.5 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.
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 third 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, including those resulting from the BENEFIT-HF
trial; 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,
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.
Condensed Consolidated
Balance Sheets
(In thousands,
except share and per share data)
(Unaudited)
| | |
June 30,
2026 | | |
December 31,
2025 | |
| Assets | |
| | | |
| | |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 64,586 | | |
$ | 75,708 | |
| Accounts receivable, net of allowances of $869 and $871, respectively | |
| 9,401 | | |
| 10,665 | |
| Inventory | |
| 13,028 | | |
| 12,205 | |
| Prepaid expenses and other current assets | |
| 2,473 | | |
| 3,069 | |
| Total current assets | |
| 89,488 | | |
| 101,647 | |
| Property and equipment, net | |
| 2,061 | | |
| 2,243 | |
| Operating lease right-of-use asset | |
| 708 | | |
| 878 | |
| Other non-current assets | |
| 26 | | |
| 26 | |
| Total assets | |
$ | 92,283 | | |
$ | 104,794 | |
| Liabilities and Stockholders’ Equity | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 3,874 | | |
$ | 3,833 | |
| Accrued expenses | |
| 7,250 | | |
| 9,484 | |
| Total current liabilities | |
| 11,124 | | |
| 13,317 | |
| Long-term debt | |
| 58,571 | | |
| 49,514 | |
| Operating lease liability, non-current portion | |
| 448 | | |
| 638 | |
| Other long-term liabilities | |
| 2,187 | | |
| 2,001 | |
| Total liabilities | |
| 72,330 | | |
| 65,470 | |
| Commitments and contingencies | |
| | | |
| | |
| Stockholders’ equity: | |
| | | |
| | |
| Common stock, $0.01 par value, 200,000,000 authorized as of June 30, 2026 and December 31, 2025; 26,641,597 and 26,311,607 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively | |
| 266 | | |
| 263 | |
| Additional paid-in capital | |
| 637,707 | | |
| 629,916 | |
| Accumulated deficit | |
| (617,816 | ) | |
| (590,652 | ) |
| Accumulated other comprehensive loss | |
| (204 | ) | |
| (203 | ) |
| Total stockholders’ equity | |
| 19,953 | | |
| 39,324 | |
| Total liabilities and stockholders’ equity | |
$ | 92,283 | | |
$ | 104,794 | |
CVRx, INC.
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(In thousands,
except share and per share data)
(Unaudited)
| | |
Three months ended
June 30, | | |
Six months ended
June 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Revenue | |
$ | 15,705 | | |
$ | 13,589 | | |
$ | 30,474 | | |
$ | 25,937 | |
| Cost of goods sold | |
| 1,981 | | |
| 2,139 | | |
| 3,869 | | |
| 4,175 | |
| Gross profit | |
| 13,724 | | |
| 11,450 | | |
| 26,605 | | |
| 21,762 | |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
| 3,130 | | |
| 2,469 | | |
| 6,214 | | |
| 4,986 | |
| Selling, general and administrative | |
| 23,617 | | |
| 23,357 | | |
| 45,575 | | |
| 44,589 | |
| Total operating expenses | |
| 26,747 | | |
| 25,826 | | |
| 51,789 | | |
| 49,575 | |
| Loss from operations | |
| (13,023 | ) | |
| (14,376 | ) | |
| (25,184 | ) | |
| (27,813 | ) |
| Interest expense | |
| (1,578 | ) | |
| (1,473 | ) | |
| (3,129 | ) | |
| (2,930 | ) |
| Other income, net | |
| 560 | | |
| 1,110 | | |
| 1,153 | | |
| 2,233 | |
| Loss before income taxes | |
| (14,041 | ) | |
| (14,739 | ) | |
| (27,160 | ) | |
| (28,510 | ) |
| Benefit (provision) for income taxes | |
| (3 | ) | |
| 3 | | |
| (4 | ) | |
| 8 | |
| Net loss | |
| (14,044 | ) | |
| (14,736 | ) | |
| (27,164 | ) | |
| (28,502 | ) |
| Cumulative translation adjustment | |
| — | | |
| 3 | | |
| — | | |
| 3 | |
| Comprehensive loss | |
$ | (14,044 | ) | |
$ | (14,733 | ) | |
$ | (27,164 | ) | |
$ | (28,499 | ) |
| Net loss per share, basic and diluted | |
$ | (0.53 | ) | |
$ | (0.57 | ) | |
$ | (1.03 | ) | |
$ | (1.10 | ) |
| Weighted-average common shares used to compute net loss per share, basic and diluted | |
| 26,515,442 | | |
| 26,071,316 | | |
| 26,435,958 | | |
| 25,974,229 | |
