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 November 5, 2026, CVRx, Inc. issued a press
release announcing its financial results for the third quarter ended September 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 Third Quarter
2026 Financial and Operating Results
MINNEAPOLIS, November 5,
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 third quarter of 2026.
Recent Highlights
| ● | Total revenue for the third quarter of 2026 was $13.8 million |
| ● | U.S. revenue for the third quarter of 2026 was $13.0 million |
| ● | Active implanting centers in the U.S. increased to 262 as of September 30,
2026, as compared to 250 as of September 30, 2025 |
| ● | A second major Medicare Advantage provider has issued a coverage policy for
Barostim, effective July 17, 2026, covering the current FDA-approved indication and patients enrolled in BENEFIT-HF. In total, these
two policies represent approximately 21% of Medicare Advantage enrollment |
| ● | Had a significant presence at the Heart Failure Society of America (HFSA)
Annual Scientific Meeting 2026 including podium presentations featuring late-breaking REBALANCE Registry data as well as new real-world
evidence in patients with heart failure with mildly reduced ejection fraction (HFmrEF) |
| ● | Appointed John Landry as Chief Financial Officer effective November 6,
2026, bringing more than 20 years of financial leadership experience in the medical device industry |
“While we recognize
there is more work ahead, we remain encouraged by the progress we are making on key strategic initiatives, including the expansion of
Medicare Advantage coverage and the clinical evidence released at HFSA,” said Kevin Hykes, President and Chief Executive Officer
of CVRx. “With new Medicare Advantage coverage policies, BENEFIT-HF enrolling, and continued focus on commercial execution, we are
confident in our ability to bring this therapy to more patients living with heart failure.”
Third Quarter 2026 Financial
and Operating Results
Revenue was $13.8 million
for the three months ended September 30, 2026, a decrease of $0.9 million, or 6%, over the three months ended September 30,
2025.
Revenue generated in the U.S.
was $13.0 million for the three months ended September 30, 2026, a decrease of $0.5 million, or 4%, over the three months ended September 30,
2025. Revenue units in the U.S. totaled 412 and 420 for the three months ended September 30, 2026, and 2025, respectively. The decreases
were primarily driven by lower sales force productivity and a prolonged challenge with one of our largest payers. Revenue also reflected
higher-than-usual implants by centers that already had existing units to implant, which was more than offset by a larger annual purchase
that occurred in the third quarter that we otherwise would have expected to occur in the fourth quarter.
As of September 30, 2026,
the Company had a total of 262 active implanting centers in the U.S., 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. As of September 30, 2026, the
number of sales territories in the U.S. was 56 as compared to 50 sales territories as of September 30, 2025.
Revenue generated in Europe
was $0.9 million for the three months ended September 30, 2026, a decrease of $0.3 million, or 27%, over the three months ended September 30,
2025. Total revenue units in Europe decreased to 38 for the three months ended September 30, 2026, compared to 50 in the prior year
period. The number of sales territories in Europe remained unchanged at five for the three months ended September 30, 2026.
Gross profit was $12.0 million
for the three months ended September 30, 2026, a decrease of $0.8 million, or 6%, over the three months ended September 30,
2025. Gross margin was 87% for both the three months ended September 30, 2026, and September 30, 2025.
R&D expenses decreased
$0.5 million, or 16%, to $2.7 million for the three months ended September 30, 2026, compared to the three months ended September 30,
2025. This change was driven by a $0.4 million decrease in headcount expenses and a $0.2 million decrease in consulting expenses, partially
offset by a $0.1 million increase in clinical trial expenses.
SG&A expenses increased
$0.5 million, or 2%, to $22.4 million for the three months ended September 30, 2026, compared to the three months ended September 30,
2025. This change was primarily driven by a $0.7 million increase in legal expenses, a $0.4 million increase in travel expenses, and a
$0.4 million increase in consulting and contract labor expenses, partially offset by a $0.8 million decrease in advertising expenses and
a $0.1 million decrease in insurance expenses.
Interest expense increased
$0.1 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. This increase
was driven by higher interest expense resulting from increased borrowings under the term loan agreement with Innovatus Capital Partners.
Other income, net decreased
$0.4 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. This decrease
was driven by lower interest income from lower balances in our interest-bearing accounts.
Net loss was $14.2 million,
or $0.52 per share, for the three months ended September 30, 2026, compared to a net loss of $12.9 million, or $0.49 per share, for
the three months ended September 30, 2025. Net loss per share was based on 27.2 million weighted-average shares outstanding for the
three months ended September 30, 2026, and 26.2 million weighted average shares outstanding for the three months ended September 30,
2025.
As of September 30, 2026,
cash and cash equivalents were $58.7 million. Net cash used in operating and investing activities was $11.0 million for the three months
ended September 30, 2026, compared to $10.0 million for the three months ended September 30, 2025.
Business Outlook
For the full year of 2026,
the Company now expects:
| ● | Total revenue between $56.0 million and $57.0 million, compared
to prior guidance of between $58.0 million and $60.0 million; |
| ● | Gross margin between 86% and 87%; |
| ● | Operating expenses between $99 million and $101 million. |
For the fourth quarter of
2026, the Company expects to report total revenue between $11.7 million and $12.7 million.
Operating Expense Reductions
The Company has taken a comprehensive
set of actions to reduce the baseline cost structure. These actions included reductions in non-commercial functions, while continuing
to invest in sales and reimbursement teams. The Company is being disciplined about filling open positions and has pulled back on marketing
and research and development projects that are not expected to impact revenue.
Clinical Evidence Presented at HFSA
Late-breaking data from the REBALANCE Registry,
the largest real-world study of Barostim-treated patients to date was presented at HFSA by Dmitry Yaranov, M.D. of Baptist Memorial Health
Care. The data evaluated 435 patients across 45 U.S. centers and has been submitted for publication in a peer reviewed journal. Improvements
in New York Heart Association (NYHA) functional class and an increase in average left ventricular ejection fraction (LVEF) were observed
over follow-up, while blood pressure and other hemodynamic parameters remained stable. In addition, real-world evidence was presented
by JoAnn Lindenfeld, M.D. of Vanderbilt University, regarding patients with HFmrEF, that included an analysis of hospitalization burden.
CFO Transition and Inducement Grant Under Nasdaq Listing Rules
As previously announced, John Landry was appointed to serve as the
Company’s Chief Financial Officer, which appointment will be effective Nov. 6, 2026. Mr. Landry succeeds Jared Oasheim
whose resignation and transition plan was previously announced.
Pursuant to Mr. Landry’s employment offer letter with the
Company, on Nov. 9, 2026, Mr. Landry will receive stock options to purchase 186,447 shares of common stock and restricted stock
units for 41,433 shares of common stock. The stock options vest as to 25% of the shares on the first annual anniversary of the date Mr. Landry’s
employment commenced and then in successive equal monthly installments over the subsequent three years. The restricted stock units vest
as to 25% of the shares on each annual anniversary of the date Mr. Landry’s employment commenced. Vesting of the awards is
subject to Mr. Landry’s continued employment with the Company and the terms and conditions in the award agreements. The exercise
price of the stock options will be equal to the closing price of the Company’s common stock on the grant date. The stock options
and restricted stock units are granted as a material inducement to Mr. Landry joining the Company in accordance with Nasdaq Listing
Rule 5635(c)(4).
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 fourth 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
ICR Healthcare
410-627-2087
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)
| | |
September 30,
2026 | | |
December 31,
2025 | |
| Assets | |
| | | |
| | |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 58,746 | | |
$ | 75,708 | |
| Accounts receivable, net of allowances of $868 and $871, respectively | |
| 9,589 | | |
| 10,665 | |
| Inventory | |
| 13,628 | | |
| 12,205 | |
| Prepaid expenses and other current assets | |
| 3,060 | | |
| 3,069 | |
| Total current assets | |
| 85,023 | | |
| 101,647 | |
| Property and equipment, net | |
| 1,940 | | |
| 2,243 | |
| Operating lease right-of-use asset | |
| 623 | | |
| 878 | |
| Other non-current assets | |
| 26 | | |
| 26 | |
| Total assets | |
$ | 87,612 | | |
$ | 104,794 | |
| Liabilities and Stockholders’ Equity | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 4,142 | | |
$ | 3,833 | |
| Accrued expenses | |
| 8,368 | | |
| 9,484 | |
| Total current liabilities | |
| 12,510 | | |
| 13,317 | |
| Long-term debt | |
| 58,655 | | |
| 49,514 | |
| Operating lease liability, non-current portion | |
| 349 | | |
| 638 | |
| Other long-term liabilities | |
| 2,280 | | |
| 2,001 | |
| Total liabilities | |
| 73,794 | | |
| 65,470 | |
| Commitments and contingencies | |
| | | |
| | |
| Stockholders’ equity: | |
| | | |
| | |
| Common stock, $0.01 par value, 200,000,000 authorized as of September 30, 2026 and December 31, 2025; 28,485,256 and 26,311,607 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively | |
| 285 | | |
| 263 | |
| Additional paid-in capital | |
| 645,716 | | |
| 629,916 | |
| Accumulated deficit | |
| (631,979 | ) | |
| (590,652 | ) |
| Accumulated other comprehensive loss | |
| (204 | ) | |
| (203 | ) |
| Total stockholders’ equity | |
| 13,818 | | |
| 39,324 | |
| Total liabilities and stockholders’ equity | |
$ | 87,612 | | |
$ | 104,794 | |
CVRx, INC.
Condensed Consolidated Statements of Operations
and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)
| | |
Three months ended
September 30, | | |
Nine months ended
September 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Revenue | |
$ | 13,832 | | |
$ | 14,690 | | |
$ | 44,306 | | |
$ | 40,627 | |
| Cost of goods sold | |
| 1,834 | | |
| 1,937 | | |
| 5,703 | | |
| 6,112 | |
| Gross profit | |
| 11,998 | | |
| 12,753 | | |
| 38,603 | | |
| 34,515 | |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
| 2,655 | | |
| 3,146 | | |
| 8,869 | | |
| 8,132 | |
| Selling, general and administrative | |
| 22,388 | | |
| 21,875 | | |
| 67,963 | | |
| 66,464 | |
| Total operating expenses | |
| 25,043 | | |
| 25,021 | | |
| 76,832 | | |
| 74,596 | |
| Loss from operations | |
| (13,045 | ) | |
| (12,268 | ) | |
| (38,229 | ) | |
| (40,081 | ) |
| Interest expense | |
| (1,607 | ) | |
| (1,480 | ) | |
| (4,736 | ) | |
| (4,410 | ) |
| Other income, net | |
| 488 | | |
| 875 | | |
| 1,641 | | |
| 3,108 | |
| Loss before income taxes | |
| (14,164 | ) | |
| (12,873 | ) | |
| (41,324 | ) | |
| (41,383 | ) |
| Benefit (provision) for income taxes | |
| 1 | | |
| 3 | | |
| (3 | ) | |
| 11 | |
| Net loss | |
| (14,163 | ) | |
| (12,870 | ) | |
| (41,327 | ) | |
| (41,372 | ) |
| Cumulative translation adjustment | |
| — | | |
| (1 | ) | |
| (1 | ) | |
| 2 | |
| Comprehensive loss | |
$ | (14,163 | ) | |
$ | (12,871 | ) | |
$ | (41,328 | ) | |
$ | (41,370 | ) |
| Net loss per share, basic and diluted | |
$ | (0.52 | ) | |
$ | (0.49 | ) | |
$ | (1.55 | ) | |
$ | (1.59 | ) |
| Weighted-average common shares used to compute net loss per share, basic and diluted | |
| 27,246,765 | | |
| 26,168,562 | | |
| 26,708,952 | | |
| 26,039,718 | |
