0001104659-23-051393.txt : 20230427 0001104659-23-051393.hdr.sgml : 20230427 20230427162909 ACCESSION NUMBER: 0001104659-23-051393 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20230427 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230427 DATE AS OF CHANGE: 20230427 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CVRx, Inc. CENTRAL INDEX KEY: 0001235912 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40545 FILM NUMBER: 23857516 BUSINESS ADDRESS: STREET 1: 9201 WEST BROADWAY AVENUE STREET 2: SUITE 650 CITY: MINNEAPOLIS STATE: MN ZIP: 55445 BUSINESS PHONE: 7634162850 MAIL ADDRESS: STREET 1: 9201 WEST BROADWAY AVENUE STREET 2: SUITE 650 CITY: MINNEAPOLIS STATE: MN ZIP: 55445 FORMER COMPANY: FORMER CONFORMED NAME: CVRX INC DATE OF NAME CHANGE: 20030527 8-K 1 tm2313916d1_8k.htm FORM 8-K
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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): April 27, 2023

 

 

 

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 April 27, 2023, CVRx, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2023. 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

 

Exhibit
No.		   Description
99.1   Press release of CVRx, Inc., dated April 27, 2023
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

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: April 27, 2023 By: /s/ Jared Oasheim
    Name: Jared Oasheim
    Its: Chief Financial Officer

 

 

 

 EX-99.1 2 tm2313916d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

CVRx Reports First Quarter 2023 Financial and Operating Results

 

MINNEAPOLIS, April 27, 2023 (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 first quarter of 2023.

 

Recent Highlights

 

●Totality of evidence from BeAT-HF post-market study shows long-term benefits for patients with heart failure

 

●U.S. Heart Failure (HF) revenue for the first quarter of 2023 was $6.8 million compared to $2.9 million in the prior year quarter, an increase of 132% over prior year quarter

 

●Active implanting centers in the U.S. grew to 122, an increase of 118% over the first quarter of 2022

 

●Worldwide revenue for the first quarter of 2023 was $8.0 million, an increase of 96% over prior year quarter

 

“I am thrilled with our first quarter performance, which demonstrated solid execution on multiple fronts. We were able to share the preliminary data from BeAT-HF during the first quarter and grow our US heart failure business. This is a testament to our team’s ability to accelerate adoption of Barostim through the increased capabilities of our commercial organization and our marketing and awareness efforts,” said Nadim Yared, President and Chief Executive Officer of CVRx. “As we look ahead to the rest of 2023, we are excited about the opportunities that lie ahead and confident that we will bring relief to patients suffering from heart failure.”

 

First Quarter 2023 Financial and Operating Results

 

Revenue was $8.0 million for the three months ended March 31, 2023, an increase of $3.9 million, or 96%, over the three months ended March 31, 2022.

 

Revenue generated in the U.S. was $6.9 million for the three months ended March 31, 2023, an increase of $3.9 million, or 127%, over the three months ended March 31, 2022. HF revenue units in the U.S. totaled 225 and 99 for the three months ended March 31, 2023 and 2022, respectively. HF revenue in the U.S. totaled $6.8 million and $2.9 million for the three months ended March 31, 2023 and 2022, 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 March 31, 2023, the Company had a total of 122 active implanting centers, as compared to 106 as of December 31, 2022. 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 29 during the three months ended March 31, 2023.

 

Revenue generated in Europe was $1.0 million for the three months ended March 31, 2023, an increase of $0.02 million, or 2%, over the three months ended March 31, 2022. Total revenue units in Europe increased to 52 for the three months ended March 31, 2023 from 50 in the prior year period. The number of sales territories in Europe remained consistent at six for the three months ended March 31, 2023.

 

Gross profit was $6.7 million for the three months ended March 31, 2023, an increase of $3.5 million, or 113%, over the three months ended March 31, 2022. Gross margin increased to 83% for the three months ended March 31, 2023 compared to 77% for the three months ended March 31, 2022. Gross margin for the three months ended March 31, 2023 improved due primarily to a decrease in the cost per unit driven by an increase in the production volume.

 

 

 

 

R&D expenses increased $1.2 million, or 51%, to $3.4 million for the three months ended March 31, 2023 compared to the three months ended March 31, 2022. This change was driven by a $0.5 million increase in compensation expenses as a result of increased headcount, a $0.4 million increase in non-cash stock-based compensation expense and a $0.4 million increase in consulting fees.

 

SG&A expenses increased $4.6 million, or 43%, to $15.4 million for the three months ended March 31, 2023 compared to the three months ended March 31, 2022. This change was primarily driven by a $2.6 million increase in compensation expenses, mainly as a result of increased headcount, a $0.8 million increase in travel expenses, a $0.6 million increase in marketing and advertising expenses associated with the commercialization of Barostim in the U.S., and a $0.5 million increase in non-cash stock-based compensation expense.

 

Other income, net was $1.1 million for the three months ended March 31, 2023 compared to other expense, net of $57,000 for the three months ended March 31, 2022. The income in the first quarter of 2023 was primarily driven by interest income on our interest-bearing account.

 

Net loss was $11.4 million, or $0.55 per share, for the three months ended March 31, 2023, compared to a net loss of $10.0 million, or $0.49 per share, for the three months ended March 31, 2022. Net loss per share was based on 20,693,224 weighted average shares outstanding for the first quarter of 2023 and 20,453,341 weighted average shares outstanding for the first quarter of 2022.

 

As of March 31, 2023, cash and cash equivalents were $103.3 million. Net cash used in operating and investing activities was $10.5 million for the quarter ended March 31, 2023, compared to $10.9 million for the quarter ended March 31, 2022.

 

Business Outlook

 

For the full year of 2023, the Company expects:

 

●Total revenue between $35.5 million and $38.0 million, compared to prior guidance of between $35.0 million and $38.0 million;

 

●Gross margin between 80.0% and 83.0%, compared to prior guidance of between 78% and 79%;

 

●Operating expenses between $76.0 million and $80.0 million.

 

For the second quarter of 2023, the Company expects to report total revenue between $8.2 million and $8.8 million.

 

Webcast and Conference Call Information

 

The Company will host a conference call to review its results at 5:00 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. 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, specifically, our 2023 expected operating and financial 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 ability to establish and maintain sales and marketing capabilities; 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, including the outbreak of the novel strain of coronavirus, COVID-19; any failure of clinical studies for future indications to produce results necessary to support regulatory clearance or approval in the U.S. or elsewhere; 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; 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, 2022, 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 Westwicke 

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)

 

   March 31,   December 31, 
   2023   2022 
Assets          
Current assets:          
Cash and cash equivalents  $103,276   $106,194 
Accounts receivable, net of allowances of $641 and $679, respectively   6,434    5,504 
Inventory   8,241    6,957 
Prepaid expenses and other current assets   2,631    4,223 
Total current assets   120,582    122,878 
Property and equipment, net   1,805    1,698 
Operating lease right-of-use asset   277    334 
Other non-current assets   27    27 
Total assets  $122,691   $124,937 
Liabilities and Stockholders’ Equity          
Current liabilities:          
Accounts payable  $1,996   $1,719 
Accrued expenses   5,961    6,369 
Total current liabilities   7,957    8,088 
Long-term debt   14,218    6,747 
Operating lease liability, non-current portion   59    117 
Other long-term liabilities   815    805 
Total liabilities   23,049    15,757 
Commitments and contingencies          
Stockholders’ equity:          
Common stock, $0.01 par value, 200,000,000 authorized as of March 31, 2023 and December 31, 2022; 20,708,940 and 20,633,736 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively   207    207 
Additional paid-in capital   547,195    545,362 
Accumulated deficit   (447,556)   (436,182)
Accumulated other comprehensive loss   (204)   (207)
Total stockholders’ equity   99,642    109,180 
Total liabilities and stockholders’ equity  $122,691   $124,937 

 

 

 

 

CVRx, INC.

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

(Unaudited)

 

   Three months ended 
   March 31, 
   2023   2022 
Revenue  $7,979   $4,076 
Cost of goods sold   1,328    949 
Gross profit   6,651    3,127 
Operating expenses:          
Research and development   3,416    2,258 
Selling, general and administrative   15,397    10,777 
Total operating expenses   18,813    13,035 
Loss from operations   (12,162)   (9,908)
Interest expense   (240)   — 
Other income (expense), net   1,062    (57)
Loss before income taxes   (11,340)   (9,965)
Provision for income taxes   (34)   (26)
Net loss   (11,374)   (9,991)
Cumulative translation adjustment   3    (6)
Comprehensive loss  $(11,371)  $(9,997)
Net loss per share, basic and diluted  $(0.55)  $(0.49)
Weighted-average common shares used to compute net loss per share, basic and diluted   20,693,224    20,453,341 

 

 

 

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