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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): February 4, 2025
CVRx,
Inc.
(Exact name of registrant as specified in its
charter)
Delaware |
|
001-40545 |
|
41-1983744 |
(State
or other jurisdiction of
incorporation) |
|
(Commission
File Number) |
|
(I.R.S.
Employer
Identification No.) |
9201
West Broadway Avenue, Suite 650
Minneapolis,
MN 55445
(Address of principal executive offices) (Zip
Code)
(763)
416-2840
(Registrant’s telephone number, including
area code)
N/A
(Former name or former address, if changed since
last report)
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):
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange
on which registered |
Common
stock, par value $0.01 per share |
|
CVRX |
|
The Nasdaq
Global Select Market |
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).
Emerging
growth company x
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02. Results of Operations and Financial Condition.
On February 4, 2025, CVRx, Inc.
issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2024. 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.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
SIGNATURES
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.
|
CVRx, Inc. |
|
|
Date: February 4, 2025 |
By: |
/s/
Jared Oasheim |
|
|
Name: Jared Oasheim |
|
|
Its: Chief Financial Officer |
Exhibit 99.1
CVRx Reports
Fourth Quarter and Full Year 2024 Financial and Operating Results
MINNEAPOLIS,
Feb. 4, 2025 (GLOBE NEWSWIRE) -- CVRx, Inc. ("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 2024.
Recent Highlights
| · | Total
revenue for the fourth quarter of 2024 was $15.3 million, an increase of 36% over the prior
year quarter |
| · | U.S.
Heart Failure (HF) revenue for the fourth quarter of 2024 was $14.3 million, an increase
of 41% over the prior year quarter |
| · | Total
revenue for 2024 was $51.3 million, an increase of 31% over the prior year |
| · | Active
implanting centers for 2024 increased to 223, a 25% increase since December 31, 2023 |
"We
capped off a very strong 2024 with a solid fourth quarter, which included 41% growth in U.S. heart failure revenue as well the successful
achievement of multiple critical reimbursement milestones," said Kevin Hykes, President and CEO of CVRx. "As we look to 2025,
we are focused on three key strategic priorities to drive Barostim toward becoming the standard of care – building a world-class
sales organization, supporting the development of sustainable Barostim programs to drive deeper utilization, and addressing barriers
to adoption. With the organization-wide success we saw in 2024, in combination with our key priorities for 2025, we are well-positioned
to drive the continued adoption of Barostim therapy."
Fourth
Quarter 2024 Financial and Operating Results
Revenue
was $15.3 million for the three months ended December 31, 2024, an increase of $4.0 million, or 36%, over the three months ended
December 31, 2023.
Revenue
generated in the U.S. was $14.4 million for the three months ended December 31, 2024, an increase of $4.1 million, or 39%, over
the three months ended December 31, 2023. HF revenue units in the U.S. totaled 457 and 330 for the three months ended December 31,
2024 and 2023, respectively. HF revenue in the U.S. totaled $14.3 million and $10.2 million for the three months ended December 31,
2024 and 2023, 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, 2024, the Company had a total of 223 active implanting centers, as compared to 208 as of September 30, 2024.
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 48 during the three months ended December 31, 2024.
Revenue
generated in Europe was $1.0 million for both the three months ended December 31, 2024 and December 31, 2023. Total revenue
units in Europe decreased to 41 for the three months ended December 31, 2024 from 52 in the prior year period. As of December 31,
2024, we had five sales territories in Europe as compared to six sales territories as of September 30, 2024.
Gross
profit was $12.8 million for the three months ended December 31, 2024, an increase of $3.2 million, or 33%, over the three months
ended December 31, 2023. Gross margin decreased to 83% for the three months ended December 31, 2024 compared to 85% for the
three months ended December 31, 2023. Gross margin for the three months December 31, 2024 was lower due to an increase in the
cost per unit.
R&D
expenses increased $0.6 million, or 25%, to $2.8 million for the three months ended December 31, 2024 compared to the three months
ended December 31, 2023. This change was primarily driven by a $0.5 million increase in clinical study expenses, a $0.2 million
increase in consulting expenses, and a $0.1 million increase in non-cash stock-based compensation expense, partially offset by a $0.2
million decrease in compensation expenses.
SG&A
expenses increased $3.2 million, or 19%, to $20.2 million for the three months ended December 31, 2024 compared to the three months
ended December 31, 2023. This change was driven by a $2.9 million increase in compensation expenses, mainly as a result of increased
headcount, a $1.0 million increase in non-cash stock-based compensation expense, and a $0.3 million increase in travel expenses, partially
offset by a $1.1 million decrease in advertising expenses.
Interest
expense increased $0.9 million to $1.5 million for the three months ended December 31, 2024 compared to the three months ended December 31,
2023. 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 was $1.1 million for each of the three months ended December 31, 2024 and 2023. Other income, net consisted primarily
of income on interest-bearing accounts.
Net
loss was $10.7 million, or $0.43 per share, for the three months ended December 31, 2024, compared to a net loss of $9.2 million,
or $0.44 per share, for the three months ended December 31, 2023. Net loss per share was based on 24.7 million weighted average
shares outstanding for three months ended December 31, 2024 and 20.8 million weighted average shares outstanding for the fourth
quarter of 2023.
For
the three months ended December 31, 2024, the Company issued 869,059 shares of common stock for gross proceeds of $12.8 million
under its at-the-market offering.
Full
Year 2024 Financial and Operating Results
Revenue
was $51.3 million for the year ended December 31, 2024, an increase of $12.0 million, or 31%, over the year ended December 31,
2023.
Revenue
generated in the U.S. was $47.2 million for the year ended December 31, 2024, an increase of $12.1 million, or 34%, over the year
ended December 31, 2023. HF revenue units in the U.S. totaled 1,506 and 1,123 for the years ended December 31, 2024 and 2023,
respectively. HF revenue in the U.S. totaled $46.8 million and $34.6 million for the years ended December 31, 2024 and 2023, respectively.
As
of December 31, 2024, the Company had a total of 223 active implanting centers, as compared to 178 as of December 31, 2023.
Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. As of December 31,
2024, we had 48 sales territories in the U.S. as compared to 38 sales territories as of December 31, 2023.
Revenue
generated in Europe was $4.1 million for the year ended December 31, 2024, a decrease of $0.1 million, or 1%, over the year ended
December 31, 2023. Total revenue units in Europe decreased to 204 for the year ended December 31, 2024, from 207 for the prior
year period. As of December 31, 2024, we had five sales territories in Europe as compared to six sales territories as of December 31,
2023.
Gross
profit was $43.0 million for the year ended December 31, 2024, an increase of $9.9 million, or 30%, over the year ended December 31,
2023. Gross margin was 84% for both the years ended December 31, 2024 and December 31, 2023.
R&D
expenses decreased $0.5 million, or 4%, to $11.1 million for the year ended December 31, 2024, compared to the year ended December 31,
2023. This change was primarily driven by a $0.5 million decrease in consulting expenses, a $0.3 million decrease in compensation expenses,
and a $0.2 million decrease in travel expenses, partially offset by a $0.5 million increase in clinical study expenses.
SG&A
expenses increased $26.8 million, or 42%, to $91.3 million for the year ended December 31, 2024, compared to the year ended December 31,
2023. This change was driven by a $12.7 million increase in non-cash stock-based compensation expense, an $11.0 million increase in compensation
expenses, mainly as a result of increased headcount, a $1.3 million increase in travel expenses, a $0.6 million increase in bad debt
expenses, and a $0.5 million increase in consulting expenses. Approximately $8.4 million of the increase in non-cash stock-based compensation
expense is related to the modification of stock options held by the former CEO in connection with his retirement in the first quarter
of 2024.
Interest
expense increased $2.6 million, to $4.4 million for the year ended December 31, 2024, compared to the year ended December 31,
2023. 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 was $4.0 million for the year ended December 31, 2024, compared to $3.9 million for the year ended December 31,
2023. This increase was primarily driven by greater interest income on our interest-bearing accounts.
Net
loss was $60.0 million, or $2.65 per share, for the year ended December 31, 2024, compared to a net loss of $41.2 million, or $1.99
per share, for the year ended December 31, 2023. Net loss per share was based on 22.6 million weighted average shares outstanding
for year ended December 31, 2024 and 20.8 million weighted average shares outstanding for the year ended December 31, 2023.
For
the year ended December 31, 2024, the Company issued 3,251,198 shares of common stock for gross proceeds of $33.8 million under
its at-the-market offering.
As
of December 31, 2024, cash and cash equivalents were $105.9 million. Net cash used in operating and investing activities was $40.5
million for the year ended December 31, 2024, compared to $39.6 million for the year ended December 31, 2023.
Business
Outlook
For
the full year of 2025, the Company continues to expect:
| · | Total
revenue between $63.0 million and $65.0 million; |
| · | Gross
margin between 83% and 84%; and |
| · | Operating
expenses between $100.0 million and $104.0 million. |
For
the first quarter of 2025, the Company expects to report total revenue between $14.5 million and $15.0 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 focused on the development and
commercialization of the Barostim™ System, the first medical technology approved by FDA that uses neuromodulation to improve the
symptoms of heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of
the carotid artery. Baroreceptors activate the body's baroreflex, which in turn triggers an autonomic response to the heart. 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 also received the CE Mark
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 2025 results), our anticipated growth strategies, 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 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 demonstrate 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, 2023 and in “Part II, Item
1A. Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, 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.
651-338-6204
emeyers@cvrx.com
CVRx, INC.
Consolidated
Balance Sheets
(In thousands,
except share and per share data)
| |
December 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 105,933 | | |
$ | 90,569 | |
Accounts receivable, net of allowances of $780 and $508, respectively | |
| 9,268 | | |
| 7,551 | |
Inventory | |
| 12,107 | | |
| 10,983 | |
Prepaid expenses and other current assets | |
| 2,505 | | |
| 2,987 | |
Total current assets | |
| 129,813 | | |
| 112,090 | |
Property and equipment, net | |
| 2,505 | | |
| 1,763 | |
Operating lease right-of-use asset | |
| 1,069 | | |
| 1,349 | |
Other non-current assets | |
| 27 | | |
| 27 | |
Total assets | |
$ | 133,414 | | |
$ | 115,229 | |
Liabilities and Stockholders’ Equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 2,582 | | |
$ | 1,884 | |
Accrued expenses | |
| 8,180 | | |
| 5,980 | |
Total current liabilities | |
| 10,762 | | |
| 7,864 | |
Long-term debt | |
| 49,273 | | |
| 29,222 | |
Operating lease liability, non-current portion | |
| 877 | | |
| 1,160 | |
Other long-term liabilities | |
| 1,447 | | |
| 1,036 | |
Total liabilities | |
| 62,359 | | |
| 39,282 | |
Commitments and contingencies | |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Common stock, $0.01 par value, 200,000,000 authorized as of December 31, 2024 and 2023; 25,324,684 and 20,879,199 shares issued and outstanding as of December 31, 2024 and 2023, respectively | |
| 253 | | |
| 209 | |
Additional paid-in capital | |
| 608,354 | | |
| 553,326 | |
Accumulated deficit | |
| (537,346 | ) | |
| (477,381 | ) |
Accumulated other comprehensive loss | |
| (206 | ) | |
| (207 | ) |
Total stockholders’ equity | |
| 71,055 | | |
| 75,947 | |
Total liabilities and stockholders’ equity | |
$ | 133,414 | | |
$ | 115,229 | |
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, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenue | |
$ | 15,342 | | |
$ | 11,305 | | |
$ | 51,292 | | |
$ | 39,295 | |
Cost of goods sold | |
| 2,571 | | |
| 1,720 | | |
| 8,334 | | |
| 6,256 | |
Gross profit | |
| 12,771 | | |
| 9,585 | | |
| 42,958 | | |
| 33,039 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 2,805 | | |
| 2,241 | | |
| 11,131 | | |
| 11,633 | |
Selling, general and administrative | |
| 20,240 | | |
| 17,005 | | |
| 91,317 | | |
| 64,509 | |
Total operating expenses | |
| 23,045 | | |
| 19,246 | | |
| 102,448 | | |
| 76,142 | |
Loss from operations | |
| (10,274 | ) | |
| (9,661 | ) | |
| (59,490 | ) | |
| (43,103 | ) |
Interest expense | |
| (1,520 | ) | |
| (579 | ) | |
| (4,397 | ) | |
| (1,799 | ) |
Other income, net | |
| 1,072 | | |
| 1,116 | | |
| 3,977 | | |
| 3,850 | |
Loss before income taxes | |
| (10,722 | ) | |
| (9,124 | ) | |
| (59,910 | ) | |
| (41,052 | ) |
Provision for income taxes | |
| 71 | | |
| (39 | ) | |
| (55 | ) | |
| (147 | ) |
Net loss | |
| (10,651 | ) | |
| (9,163 | ) | |
| (59,965 | ) | |
| (41,199 | ) |
Cumulative translation adjustment | |
| 2 | | |
| 1 | | |
| 1 | | |
| — | |
Comprehensive loss | |
$ | (10,649 | ) | |
$ | (9,162 | ) | |
$ | (59,964 | ) | |
$ | (41,199 | ) |
Net loss per share, basic and diluted | |
$ | (0.43 | ) | |
$ | (0.44 | ) | |
$ | (2.65 | ) | |
$ | (1.99 | ) |
Weighted-average common shares used to compute net loss per share, basic and diluted | |
| 24,715,681 | | |
| 20,826,634 | | |
| 22,596,229 | | |
| 20,754,375 | |
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