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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): March 3, 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 March 3, 2022, Stereotaxis, Inc. (the “Company”) issued a press release (the “Earnings Press Release”) setting forth its financial results for the 2021 fourth quarter and full year. 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 March 3, 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: March 3, 2022 By: /s/ Kimberly R. Peery
  Name: Kimberly R. Peery
  Title: Chief Financial Officer

 

 

 

 

Exhibit 99.1

 

 

 

Stereotaxis Reports 2021 Full Year Financial Results

 

ST. LOUIS, Mar. 3, 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 fourth quarter and full year ended December 31, 2021.

 

“In 2021 we delivered significant revenue growth, drove a resurgence in adoption of robotics, advanced a broad wave of transformational innovations, and maintained financial discipline,” said David Fischel, Chairman and CEO.

 

“Renewed global adoption of robotic systems drove revenue growth of 32% for the year. We sold seven systems during 2021, the majority to hospitals establishing new robotic programs. We begin 2022 with purchase orders for four robotic systems and an expectation of multiple additional near-term orders that should drive revenue growth for this year. However, replacement activity remains below normalized levels with multiple opportunities delayed predominantly due to hospital construction supply chain and labor issues.”

 

“Stereotaxis is methodically advancing a robust innovation pipeline including a novel accessible robot, proprietary ablation catheters, vascular navigation devices, and an operating room connectivity solution. We expect regulatory submissions and initial commercial launches for all these within the next year and a half. Collectively, they serve as the foundational product ecosystem for a preeminent medical robotics company which can broadly transform endovascular interventions.”

 

“Concurrent with our commercial and technological progress, we are enhancing our infrastructure and team. We established a new headquarters and manufacturing facility that will support many years of growth. This progress is made while remaining prudent with shareholder capital. Stereotaxis starts the year with $40 million in cash and a modest controlled operating loss as we invest in innovation and growth.”

 

2021 Fourth Quarter and Full Year Financial Results

 

Revenue for the fourth quarter of 2021 totaled $8.2 million, representing growth of 21% from $6.8 million in the prior year fourth quarter. System revenue was $2.3 million with recurring revenue of $5.7 million, compared to $0.7 million and $5.9 million, respectively, in the prior year fourth quarter. Revenue for the full year 2021 totaled $35.0 million with growth of 32% from $26.6 million in 2020. System revenue of $11.2 million increased from $3.6 million in the prior year reflecting increasing adoption of our Genesis RMN systems. Recurring revenue of $22.9 million increased 4% from the prior year reflecting a partial recovery of procedure volumes.

 

Gross margin for the fourth quarter and full year 2021 were approximately 72% and 66% of revenue, respectively. Operating expenses in the fourth quarter were $9.3 million. Excluding $2.6 million in non-cash stock compensation expense, adjusted operating expenses in the current quarter were $6.7 million, compared to the prior year adjusted operating expenses of $5.7 million. Adjusted operating expenses for the full year 2021 were $26.9 million, up from $22.6 million in the prior year.

 

Operating loss and net loss for the fourth quarter of 2021 were both approximately ($3.4) million, compared to ($1.2) million for both in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding non-cash stock compensation expense, were ($0.8) million, compared to ($0.4) million for both in the previous year. For the full year 2021, adjusted operating loss of ($3.6) million and adjusted net loss of ($1.4) million compared to ($3.6) million and ($3.5) million, respectively, in the prior year. Net loss in the current year reflects a favorable $2.2 million adjustment for the forgiveness of the Paycheck Protection Loan. Negative free cash flow for the full year 2021 was ($4.3) million, compared to ($3.6) million for the full year 2020.

 

 
 

 

Cash Balance and Liquidity

 

At December 31, 2021, Stereotaxis had cash and cash equivalents, including restricted cash, of $40.1 million and no debt.

 

Forward Looking Expectations

 

Stereotaxis anticipates revenue growth for the year driven by continued commercial adoption of the Genesis RMN system and stable recurring revenue. System revenue for the year will be primarily recognized in the second half of the year based on current customer schedules. Stereotaxis expects to modestly grow operating expenses with continued investment in key growth drivers, while maintaining a robust balance sheet that allows it to reach profitability without the need for additional financings. Stereotaxis is methodically establishing the product ecosystems that allow for significant future growth in electrophysiology and the broader field of endovascular surgery.

 

Conference Call and Webcast

 

Stereotaxis will host a conference call and webcast today, March 3, 2022, at 10:00 a.m. Eastern Time. To access the conference call, dial 1-866-409-1555 (US and Canada) or 1-313-209-4906 (International) and give the participant pass code 7498243. 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 https://ir.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.

 

Company Contacts:

 

David L. Fischel

Chairman and Chief Executive Officer

 

Kimberly R. Peery

Chief Financial Officer

 

314-678-6100

Investors@Stereotaxis.com

 

 
 

 

STEREOTAXIS, INC.

STATEMENTS OF OPERATIONS

(Unaudited)

 

   Three Months Ended
December 31,
   Year Ended
December 31,
 
   2021   2020   2021   2020 
                 
Revenue:                    
Systems  $2,337,624   $660,510   $11,167,676   $3,626,284 
Disposables, service and accessories   5,656,276    5,917,716    22,867,066    22,017,631 
Sublease   246,530    246,530    986,120    986,120 
Total revenue   8,240,430    6,824,756    35,020,862    26,630,035 
                     
Cost of revenue:                    
Systems   1,326,595    461,440    7,526,575    3,715,416 
Disposables, service and accessories   718,077    894,625    3,276,491    2,962,710 
Sublease   246,530    246,530    986,120    986,120 
Total cost of revenue   2,291,202    1,602,595    11,789,186    7,664,246 
                     
Gross margin   5,949,228    5,222,161    23,231,676    18,965,789 
                     
Operating expenses:                    
Research and development   2,614,645    2,098,161    10,198,553    8,136,914 
Sales and marketing   3,045,968    2,898,472    11,948,068    11,178,325 
General and administrative   3,638,398    1,402,138    13,973,498    6,364,365 
Total operating expenses   9,299,011    6,398,771    36,120,119    25,679,604 
Operating loss   (3,349,783)   (1,176,610)   (12,888,443)   (6,713,815)
Interest (expense) income, net   (4,486)   (4,240)   (10,071)   67,356 
Gain on extinguishment of debt   -    -    2,182,891    - 
Net loss  $(3,354,269)  $(1,180,850)  $(10,715,623)  $(6,646,459)
Cumulative dividend on convertible preferred stock   (338,565)   (340,471)   (1,345,031)   (1,369,421)
Net loss attributable to common stockholders  $(3,692,834)  $(1,521,321)  $(12,060,654)  $(8,015,880)
                     
Net loss per share attributed to common stockholders:                    
Basic  $(0.05)  $(0.02)  $(0.16)  $(0.11)
                     
Diluted  $(0.05)  $(0.02)  $(0.16)  $(0.11)
                     
Weighted average number of common shares and equivalents:                    
Basic   75,801,866    74,954,091    75,558,233    72,746,268 
                     
Diluted   75,801,866    74,954,091    75,558,233    72,746,268 

 

 
 

 

STEREOTAXIS, INC.

BALANCE SHEETS

 

   December 31,
2021
   December 31,
2020
 
   (Unaudited)     
Assets          
Current assets:          
Cash and cash equivalents  $38,738,591   $43,939,512 
Restricted cash - current   454,268    - 
Compensating cash arrangement   -    250,620 
Accounts receivable, net of allowance of $179,913 and $123,614 at 2021 and 2020, respectively   5,405,860    3,515,136 
Inventories, net   4,433,394    3,295,457 
Prepaid expenses and other current assets   2,356,190    1,716,014 
Total current assets   51,388,303    52,716,739 
Property and equipment, net   2,631,891    195,129 
Restricted cash   951,563    - 
Operating lease right-of-use assets   5,734,775    2,235,442 
Other assets   278,154    308,515 
Total assets  $60,984,686   $55,455,825 
           
Liabilities and stockholders’ equity          
Current liabilities:          
Short-term debt  $-   $1,185,058 
Accounts payable   4,188,471    1,608,636 
Accrued liabilities   2,528,189    3,209,235 
Deferred revenue   6,276,781    5,282,770 
Current portion of operating lease liabilities   268,121    2,287,487 
Total current liabilities   13,261,562    13,573,186 
           
Long-term debt   -    973,252 
Long-term deferred revenue   2,238,150    548,915 
Operating lease liabilities   5,842,456    - 
Other liabilities   218,582    131,231 
Total liabilities   21,560,750    15,226,584 
           
Series A - Convertible preferred stock:          
Convertible preferred stock, Series A, par value $0.001; 22,387 and 22,513 shares outstanding at 2021 and 2020, respectively   5,583,768    5,605,323 
Stockholders’ equity:          
Convertible preferred stock, Series B, par value $0.001; 10,000,000 shares authorized, 5,610,121 shares outstanding at 2021 and 2020   5,610    5,610 
Common stock, par value $0.001; 300,000,000 shares authorized, 74,618,240 and 73,694,203 shares issued at 2021 and 2020, respectively   74,618    73,694 
Additional paid-in capital   532,640,795    522,709,846 
Treasury stock, 4,015 shares at 2021 and 2020   (205,999)   (205,999)
Accumulated deficit   (498,674,856)   (487,959,233)
Total stockholders’ equity   33,840,168    34,623,918 
Total liabilities and stockholders’ equity  $60,984,686   $55,455,825 

 

 

 

Innovation Day