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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): October 29, 2024
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 October 29, 2024, CVRx, Inc.
issued a press release announcing its financial results for the quarter ended September 30, 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: October 29, 2024 |
By: |
/s/
Jared Oasheim |
| |
|
Name: Jared Oasheim |
| |
|
Its: Chief Financial Officer |
Exhibit 99.1
CVRx Reports Third Quarter 2024 Financial and
Operating Results
MINNEAPOLIS, Oct. 29, 2024 (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 2024.
Recent Highlights
| · | Total revenue for the third quarter 2024 was $13.4 million, an increase of 27% over the prior year quarter |
| · | U.S. Heart Failure (HF) revenue for the third quarter of 2024 was $12.2 million, an increase of 30% over the prior year quarter |
| · | Active implanting centers in the U.S. were 208, an increase of 31% over the prior year quarter |
| · | Final Inpatient Prospective Payment System rule confirmed the reassignment of Barostim to MS-DRG 276, increasing payment to
hospitals from approximately $17,000-$23,000 to approximately $43,000 effective October 1, 2024 |
| · | The American Medical Association CPT® Editorial Panel accepted new Current Procedural Terminology (CPT) Category I codes for
Barostim to treat the symptoms of heart failure, expected to take effect January 1, 2026 |
| · | New data published in JACC: Heart Failure demonstrated durable quality of life benefits of Barostim in heart failure patients with
reduced ejection fraction |
“We're thrilled with our continued strong performance in the
third quarter, which reflects the growing adoption of Barostim therapy and the dedication of our team,” said Kevin Hykes, President
and Chief Executive Officer of CVRx. "The recent favorable news regarding inpatient reimbursement and the Category 1 code, coupled
with new long-term data demonstrating Barostim’s durable quality of life benefits, strengthens our position in the market. We remain
focused on improving patient access, increasing education and awareness, and expanding our clinical evidence base. These developments,
along with our strengthened leadership team and stabilized sales force reinforce our confidence in Barostim's potential to become standard
of care for patients suffering from the debilitating symptoms of heart failure."
Third Quarter 2024 Financial and Operating Results
Revenue was $13.4 million for the three months ended September 30,
2024, an increase of $2.9 million, or 27%, over the three months ended September 30, 2023.
Revenue generated in the U.S. was $12.3 million for the three months
ended September 30, 2024, an increase of $2.7 million, or 28%, over the three months ended September 30, 2023. HF revenue units
in the U.S. totaled 391 and 303 for the three months ended September 30, 2024 and 2023, respectively. HF revenue in the U.S. totaled
$12.2 million and $9.4 million for the three months ended September 30, 2024 and 2023, 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 September 30, 2024, the Company had a total of 208 active
implanting centers in the U.S., as compared to 189 as of June 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
45 during the three months ended September 30, 2024.
Revenue generated in Europe was $1.1 million for the three months ended
September 30, 2024, a nominal increase compared to the three months ended September 30, 2023. Total revenue units in Europe
increased to 56 for the three months ended September 30, 2024 from 47 in the prior year period. The number of sales territories in
Europe remained consistent at six for the three months ended September 30, 2024.
Gross profit was $11.1 million for the three months ended September 30,
2024, an increase of $2.3 million, or 26%, over the three months ended September 30, 2023. Gross margin was 83% and 84% for the three
months ended September 30, 2024 and September 30, 2023, respectively.
R&D expenses decreased $0.2 million, or 7%, to $2.5 million for
the three months ended September 30, 2024 compared to the three months ended September 30, 2023, driven by a decrease in consulting
expenses.
SG&A expenses increased $6.0 million, or 38%, to $21.6 million
for the three months ended September 30, 2024 compared to the three months ended September 30, 2023. This change was primarily
driven by a $3.7 million increase in compensation expenses, mainly as a result of increased headcount, a $1.1 million increase in non-cash
stock-based compensation expense, a $0.5 million increase in travel expenses, and a $0.4 million increase in advertising expenses.
Interest expense increased $0.5 million for the three months ended
September 30, 2024, compared to the three months ended September 30, 2023, driven by the increased borrowings under the term
loan agreement with Innovatus Capital Partners.
Other income, net decreased $0.1 million for the three months ended
September 30, 2024, compared to the three months ended September 30, 2023. This decrease was primarily driven by less interest
income on our interest-bearing accounts.
Net loss was $13.1 million, or $0.57 per share, for the three months
ended September 30, 2024, compared to a net loss of $9.0 million, or $0.43 per share, for the three months ended September 30,
2023. Net loss per share was based on 22.8 million weighted average shares outstanding for three months ended September 30, 2024
and 20.8 million weighted average shares outstanding for the three months ended September 30, 2023.
As of September 30, 2024, cash and cash equivalents were $100.2
million. Net cash used in operating and investing activities was $10.4 million for the three months ended September 30, 2024 as compared
to $10.2 million for the three months ended June 30, 2024.
On
September 30, 2024, the Company borrowed the remaining $20.0 million under the third and final tranche of the Innovatus loan agreement,
such that the outstanding principal balance is $50.0 million.
For
the three months ended September 30, 2024, the Company issued 2,358,775 shares of common stock for gross proceeds of $20.3
million under its at-the-market offering.
Final Inpatient Prospective Payment System Rule
In August 2024, the Company announced that the Centers for Medicare
and Medicaid Services (CMS) has reassigned the Barostim implant procedure for the inpatient setting as part of the Medicare Hospital Inpatient
Prospective Payment System (IPPS) final rule for CMS’ Fiscal Year 2025, which began on October 1, 2024. On that date,
Barostim was reassigned to MS-DRG 276, which carries a national average payment of approximately $43,000, a significant increase from
the previous payment range of $17,000-$23,000, which is expected to facilitate increased access to the therapy for patients with heart
failure.
AMA Approves Category I CPT Codes for Barostim Therapy
The American Medical Association's CPT Editorial Panel approved new
Category I codes for Barostim therapy, effective January 1, 2026. Led by the Society for Vascular Surgery with support from the American
College of Cardiology, this advancement from Category III to Category I status reflects Barostim's growing adoption and established clinical
evidence in treating heart failure symptoms. The new designation is expected to streamline reimbursement processes and expand access to
this important therapy for heart failure patients.
Long-term Quality of Life Benefits of Barostim
In September 2024, the Company announced the publication of new
data in the Journal of the American College of Cardiology: Heart Failure, detailing the durable improvements in Barostim patients out
to 24-months in quality of life measures. The data demonstrated that patients receiving Barostim plus guideline-directed medical therapy
reported feeling significantly better in a variety of physical and psychosocial measures compared to patients who received guideline-directed
medical therapy alone. This publication builds on the data from the BeAT-HF trial published in 2024 in the European Journal of Heart Failure
demonstrating the long-term sustained symptomatic benefits of Barostim in heart failure patients with reduced ejection fraction.
Business Outlook
For the full year of 2024, the Company expects:
| · | Total revenue between $50.5 million and $51.5 million, narrowed from previously issued guidance of $50.0 million to $53.0 million; |
| · | Gross margin between 83% and 85%, unchanged from previously issued guidance; and |
| · | Operating expenses of approximately $100 million, up from previously issued guidance of $95 million to $98 million. |
For the fourth quarter of 2024, the Company expects to report total
revenue between $14.5 million and $15.5 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 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
fourth quarter 2024 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, 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:
Laura O’Neill
Finn Partners
402-499-8203
laura.oneill@finnpartners.com
CVRx, INC.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
| | |
September 30, | | |
December 31, | |
| | |
2024 | | |
2023 | |
| Assets | |
| | | |
| | |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 100,161 | | |
$ | 90,569 | |
| Accounts receivable, net of allowances of $522 and $508, respectively | |
| 9,033 | | |
| 7,551 | |
| Inventory | |
| 11,892 | | |
| 10,983 | |
| Prepaid expenses and other current assets | |
| 2,786 | | |
| 2,987 | |
| Total current assets | |
| 123,872 | | |
| 112,090 | |
| Property and equipment, net | |
| 2,631 | | |
| 1,763 | |
| Operating lease right-of-use asset | |
| 1,144 | | |
| 1,349 | |
| Other non-current assets | |
| 26 | | |
| 27 | |
| Total assets | |
$ | 127,673 | | |
$ | 115,229 | |
| Liabilities and Stockholders’ Equity | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 3,276 | | |
$ | 1,884 | |
| Accrued expenses | |
| 7,671 | | |
| 5,980 | |
| Total current liabilities | |
| 10,947 | | |
| 7,864 | |
| Long-term debt | |
| 49,214 | | |
| 29,222 | |
| Operating lease liability, non-current portion | |
| 951 | | |
| 1,160 | |
| Other long-term liabilities | |
| 1,378 | | |
| 1,036 | |
| Total liabilities | |
| 62,490 | | |
| 39,282 | |
| Commitments and contingencies | |
| | | |
| | |
| Stockholders’ equity: | |
| | | |
| | |
| Common stock, $0.01 par value, 200,000,000 authorized as of September 30, 2024 and December 31, 2023; 24,203,658 and 20,879,199 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively | |
| 242 | | |
| 209 | |
| Additional paid-in capital | |
| 591,844 | | |
| 553,326 | |
| Accumulated deficit | |
| (526,695 | ) | |
| (477,381 | ) |
| Accumulated other comprehensive loss | |
| (208 | ) | |
| (207 | ) |
| Total stockholders’ equity | |
| 65,183 | | |
| 75,947 | |
| Total liabilities and stockholders’ equity | |
$ | 127,673 | | |
$ | 115,229 | |
CVRx, INC.
Condensed Consolidated Statements of Operations
and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)
| | |
Three months ended | | |
Nine months ended | |
| | |
September 30, | | |
September 30, | |
| | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| Revenue | |
$ | 13,373 | | |
$ | 10,511 | | |
$ | 35,950 | | |
$ | 27,990 | |
| Cost of goods sold | |
| 2,248 | | |
| 1,691 | | |
| 5,763 | | |
| 4,536 | |
| Gross profit | |
| 11,125 | | |
| 8,820 | | |
| 30,187 | | |
| 23,454 | |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
| 2,504 | | |
| 2,696 | | |
| 8,326 | | |
| 9,392 | |
| Selling, general and administrative | |
| 21,632 | | |
| 15,652 | | |
| 71,077 | | |
| 47,504 | |
| Total operating expenses | |
| 24,136 | | |
| 18,348 | | |
| 79,403 | | |
| 56,896 | |
| Loss from operations | |
| (13,011 | ) | |
| (9,528 | ) | |
| (49,216 | ) | |
| (33,442 | ) |
| Interest expense | |
| (958 | ) | |
| (499 | ) | |
| (2,877 | ) | |
| (1,220 | ) |
| Other income, net | |
| 917 | | |
| 1,056 | | |
| 2,905 | | |
| 2,734 | |
| Loss before income taxes | |
| (13,052 | ) | |
| (8,971 | ) | |
| (49,188 | ) | |
| (31,928 | ) |
| Provision for income taxes | |
| (47 | ) | |
| (40 | ) | |
| (126 | ) | |
| (108 | ) |
| Net loss | |
| (13,099 | ) | |
| (9,011 | ) | |
| (49,314 | ) | |
| (32,036 | ) |
| Cumulative translation adjustment | |
| 2 | | |
| (21 | ) | |
| (1 | ) | |
| (1 | ) |
| Comprehensive loss | |
$ | (13,097 | ) | |
$ | (9,032 | ) | |
$ | (49,315 | ) | |
$ | (32,037 | ) |
| Net loss per share, basic and diluted | |
$ | (0.57 | ) | |
$ | (0.43 | ) | |
$ | (2.25 | ) | |
$ | (1.55 | ) |
| Weighted-average common shares used to compute net loss per share, basic and diluted | |
| 22,783,337 | | |
| 20,801,350 | | |
| 21,884,588 | | |
| 20,730,024 | |
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