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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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): November 10, 2022

 

STEREOTAXIS, INC.

 

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

 

(State or Other Jurisdiction of Incorporation)

 

001-36159   94-3120386
(Commission File Number)   (IRS Employer Identification No.)

 

710 North Tucker Boulevard, Suite 110, St. Louis, Missouri   63101
(Address of Principal Executive Offices)   (Zip Code)

 

(314) 678-6100

 

(Registrant’s Telephone Number, Including Area Code)

 

 

 

(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:

 

  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))

 

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

 

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.☐

 

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 $0.001 per share   STXS   NYSE American LLC

 

 

 

 
 

 

Item 2.02 Results of Operations and Financial Condition

 

On November 10, 2022, Stereotaxis, Inc. (the “Company”) issued a press release (the “Earnings Press Release”) setting forth its financial results for the 2022 third quarter. A copy of the Earnings Press Release is being filed as Exhibit 99.1 hereto, and the statements contained therein are incorporated by reference herein.

 

Forward-Looking Statements and Additional Information

 

Statements are made herein or incorporated herein that are “forward-looking statements” as defined by the Securities and Exchange Commission (the “SEC”). All statements, other than statements of historical fact, included or incorporated herein that address activities, events or developments that the Company expects, believes or anticipates will or may occur in the future are forward-looking statements. These statements are not guarantees of future events or the Company’s future performance and are subject to risks, uncertainties and other important factors that could cause events or the Company’s actual performance or achievements to be materially different than those projected by the Company. For a full discussion of these risks, uncertainties and factors, the Company encourages you to read its documents on file with the SEC. Except as required by law, the Company does not intend to update or revise its forward-looking statements, whether as a result of new information, future events or otherwise.

 

In accordance with General Instruction B.2. of Form 8-K, the information contained in Item 2.02 and Exhibit 99.1 attached hereto shall not be deemed “filed” 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, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits.

 

99.1 Stereotaxis, Inc. Earnings Press Release dated November 10, 2022.
   
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.

 

  STEREOTAXIS, INC.
     
Date: November 10, 2022 By: /s/ Kimberly R. Peery
  Name: Kimberly R. Peery
  Title: Chief Financial Officer

 

 

 

Exhibit 99.1

 

 

Stereotaxis Reports 2022 Third Quarter Financial Results

 

ST. LOUIS, MO, Nov. 10, 2022 (GLOBE NEWSWIRE) – Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the third quarter ended September 30, 2022.

 

“Stereotaxis continues to demonstrate robust commercial and technological progress,” said David Fischel, Chairman and CEO. “We received two system orders in the third quarter, and have already received two additional signed purchase contracts as we start the fourth quarter, reflecting continued global demand for our robotic technology. Our growing system backlog of over $13 million, along with a healthy capital pipeline, sets us up well for the coming year.”

 

“Alongside this commercial execution, we are making significant progress on a robust innovation strategy. The CE Mark submission of the MAGiC ablation catheter successfully passed a completeness check by the notified body and is in the midst of its technical review. Development of the accessible next generation robotic system is progressing well and remains on track for an initial launch next summer. Our collaboration with MicroPort is advancing rapidly on multiple fronts and we expect near-term regulatory submission of the Genesis system in China.”

 

“This progress brings us closer to a future when the benefits of robotic magnetic navigation are broadly accessible, available with a vibrant ecosystem in electrophysiology, and impactful across multiple endovascular indications. We are cognizant of the importance of financial prudence and remain confident in the ability to advance our strategy, generate organic growth, and reach profitability with our current financial resources.”

 

2022 Third Quarter Financial Results

 

Revenue for the third quarter of 2022 totaled $7.7 million, compared to $9.1 million in the prior year third quarter. Recurring revenue for the third quarter was $5.3 million and system revenue was $2.4 million. The decrease in revenue is primarily driven by reduced system revenue, as hospital construction delays continue to slow the conversion of order backlog into revenue.

 

Gross margin for the third quarter of 2022 was 60% of revenue, with recurring revenue gross margin of 80% and system gross margin of 16%. Operating expenses in the quarter of $9.6 million include $2.7 million in non-cash stock compensation expense. Excluding stock compensation expense, adjusted operating expenses were $6.9 million compared to $6.8 million in the prior year third quarter and down from $7.2 million sequentially from the current year second quarter.

 

Operating loss and net loss for the third quarter of 2022 were ($5.1) million and ($4.9) million, respectively, compared to ($4.6) million for both in the previous year. Adjusted operating loss and adjusted net loss, excluding non-cash stock compensation expense were ($2.4) million and ($2.2) million for the quarter. Negative free cash flow for the third quarter was ($2.7) million. Negative cash flow this year so far has been significantly impacted by over $2 million spent on one-time expenses for our new headquarters and manufacturing facility as well as an over $3 million increase in inventory.

 

Cash Balance and Liquidity

 

At September 30, 2022, Stereotaxis had cash and cash equivalents, including restricted cash, of $32.4 million and no debt.

 

 
 

 

Forward Looking Expectations

 

While system revenue in any given quarter remains difficult to predict, growing system backlog of over $13 million, along with a healthy capital pipeline support an expectation of year-over-year revenue growth over the coming quarters. Substantial revenue growth in the coming years is expected to be supported by new technology launches and an enhanced commercial organization. Stereotaxis’ robust balance sheet allows it to reach profitability without the need for additional financings.

 

Conference Call and Webcast

 

Stereotaxis will host a conference call and webcast today, November 10, 2022, at 10:00 a.m. Eastern Time. To access the conference call, dial 1-800-715-9871 (US and Canada) or 1-646-307-1963 (International) and give the participant pass code 5729833. Participants are asked to call 5-10 minutes prior to the start time. To access the live and replay webcast, please visit the investor relations section of the Stereotaxis website at www.Stereotaxis.com.

 

About Stereotaxis

 

Stereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 100,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.Stereotaxis.com.

 

This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled.

 

Investor Contacts:   Media Contact:
     
David L. Fischel   Bethanne Schluter
Chairman and Chief Executive Officer   Director, Marketing & Communications
     
Kimberly Peery  
Chief Financial Officer    
     
314-678-6100    
Investors@Stereotaxis.com    

 

 
 

 

STEREOTAXIS, INC.

STATEMENTS OF OPERATIONS

(Unaudited)

 

(in thousands, except share and per share amounts) 

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
   2022   2021   2022   2021 
                 
Revenue:                    
Systems  $2,413   $3,541   $4,649   $8,829 
Disposables, service and accessories   5,244    5,319    16,197    17,211 
Sublease   -    246    -    740 
Total revenue   7,657    9,106    20,846    26,780 
                     
Cost of revenue:                    
Systems   2,016    3,375    3,817    6,200 
Disposables, service and accessories   1,074    751    2,868    2,558 
Sublease   -    246    -    740 
Total cost of revenue   3,090    4,372    6,685    9,498 
                     
Gross margin   4,567    4,734    14,161    17,282 
                     
Operating expenses:                    
Research and development   2,818    2,500    8,158    7,584 
Sales and marketing   3,111    2,910    9,337    8,902 
General and administrative   3,690    3,944    10,986    10,335 
Total operating expenses   9,619    9,354    28,481    26,821 
Operating loss   (5,052)   (4,620)   (14,320)   (9,539)
                     
Interest income (expense), net   135    1    182    (5)
Gain on extinguishment of debt   -    -    -    2,183 
Net loss  $(4,917)  $(4,619)  $(14,138)  $(7,361)
Cumulative dividend on convertible preferred stock   (339)   (338)   (1,005)   (1,007)
Net loss attributable to common stockholders  $(5,256)  $(4,957)  $(15,143)  $(8,368)
                     
Net loss per share attributed to common stockholders:                    
Basic  $(0.07)  $(0.07)  $(0.20)  $(0.11)
                     
Diluted  $(0.07)  $(0.07)  $(0.20)  $(0.11)
                     
Weighted average number of common shares and equivalents:                    
Basic   76,100,007    75,700,389    75,977,920    75,476,381 
                     
Diluted   76,100,007    75,700,389    75,977,920    75,476,381 

 

 
 

 

STEREOTAXIS, INC.

BALANCE SHEETS

 

(in thousands, except share amounts) 

September 30,

2022

  

December 31,

2021

 
   (Unaudited)     
Assets          
Current assets:          
Cash and cash equivalents  $30,938   $38,739 
Restricted cash - current   618    454 
Accounts receivable, net of allowance of $227 and $180 at 2022 and 2021, respectively   5,077    5,406 
Inventories, net   8,161    4,433 
Prepaid expenses and other current assets   1,285    2,356 
Total current assets   46,079    51,388 
Property and equipment, net   3,409    2,632 
Restricted cash   875    952 
Operating lease right-of-use assets   5,479    5,735 
Prepaid and other non-current assets   233    278 
Total assets  $56,075   $60,985 
           
Liabilities and stockholders’ equity          
Current liabilities:          
Accounts payable  $3,941   $4,189 
Accrued liabilities   3,211    2,528 
Deferred revenue   8,043    6,277 
Current portion of operating lease liabilities   359    268 
Total current liabilities   15,554    13,262 
Long-term deferred revenue   1,416    2,238 
Operating lease liabilities   5,586    5,842 
Other liabilities   168    219 
Total liabilities   22,724    21,561 
           
Series A - Convertible preferred stock:          
Convertible preferred stock, Series A, par value $0.001; 22,386 and 22,387 shares outstanding at 2022 and 2021, respectively   5,584    5,584 
Stockholders’ equity:          
Convertible preferred stock, Series B, par value $0.001; 10,000,000 shares authorized, 5,610,121 shares outstanding at 2022 and 2021   6    6 
Common stock, par value $0.001; 300,000,000 shares authorized, 74,832,278 and 74,618,240 shares issued at 2022 and 2021, respectively   75    75 
Additional paid-in capital   540,706    532,641 
Treasury stock, 4,015 shares at 2022 and 2021   (206)   (206)
Accumulated deficit   (512,814)   (498,676)
Total stockholders’ equity   27,767    33,840 
Total liabilities and stockholders’ equity  $56,075   $60,985 

 

 

 

Innovation Day