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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): August 12, 2024

 

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 August 12, 2024, Stereotaxis, Inc. (the “Company”) issued a press release (the “Earnings Press Release”) setting forth its financial results for the 2024 second 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 August 12, 2024.
     
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: August 12, 2024 By: /s/ Kimberly R. Peery
  Name: Kimberly R. Peery
  Title: Chief Financial Officer

 

 

 

Exhibit 99.1

 

 

Stereotaxis Reports 2024 Second Quarter Financial Results

 

ST. LOUIS, August 12, 2024 (GLOBE NEWSWIRE) – Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the second quarter ended June 30, 2024.

 

“We made significant progress over the last quarter on strategic innovation efforts that are establishing a solid foundation upon which to build a substantial and successful company,” said David Fischel, Chairman and CEO. “Key milestones achieved include successfully obtaining CE mark in Europe and submitting a 510(k) application in the US for GenesisX, substantial progress with regulatory reviews of MAGiC in Europe and the US, and closing the acquisition of Access Point Technologies (APT).” In a separate press release issued concurrent with this release, Stereotaxis introduced its next-generation robotic system GenesisX.

 

“We have attempted to realize our strategic transformation while maintaining commercial momentum and preserving financial strength. Commercial results for the first half of the year were below expectations with delayed recognition of revenue from our capital backlog. Our visibility into the second half of this year provides high confidence in significantly improved revenue and cash flow. Multiple Genesis systems are in transit to customers with revenue to be recognized and cash received at delivery. We have an active late-stage pipeline with additional orders expected near-term.”

 

2024 Second Quarter Financial Results

 

Revenue for the second quarter of 2024 totaled $4.5 million, compared to $7.9 million in the prior year second quarter. System revenue of $0.2 million and recurring revenue of $4.3 million, compared to $3.3 million and $4.6 million, respectively, in the prior year second quarter. System revenue was weaker than expected due to delays in hospital construction schedules but does not reflect normalized expectations. Recurring revenue was in line with recent quarters.

 

Gross margin for the second quarter of 2024 was 74% of revenue. Operating expenses in the second quarter of $9.3 million include $2.5 million in non-cash stock compensation expense. Operating expenses in the quarter were impacted by higher acquisition-related legal costs and regulatory-related activities counteracted by the reversal of a historical accrued liability. Excluding non-cash stock compensation expense, adjusted operating expenses in the quarter were $6.8 million, compared to $6.9 million in the prior year second quarter.

 

Operating loss and net loss for the second quarter of 2024 were ($6.0) million and ($5.8) million, respectively, compared to ($5.3) million and ($5.0) million in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding non-cash stock compensation expense, were ($3.5) million and ($3.3) million, respectively, compared with ($2.7) million and ($2.4) million in the previous year. Negative free cash flow for the second quarter was ($3.1) million.

 

Cash Balance and Liquidity

 

At June 30, 2024, Stereotaxis had cash and cash equivalents, including restricted cash, of $15.2 million and no debt.

 

 

 

 

Forward Looking Expectations

 

Stereotaxis expects greater than $14 million in revenue in the second half of this year given stable recurring revenue and current Genesis system shipments. Full year revenue is expected to be approximately equal to the previous year. These expectations do not incorporate contributions of revenue from APT or potential revenue from the launch of GenesisX and MAGiC.

 

Stereotaxis expects to end this year with approximately $13 million cash and no debt. Stereotaxis expects its balance sheet to allow it to advance its transformative product ecosystem to market, fund its commercialization, and reach profitability without the need for additional financing.

 

Conference Call and Webcast

 

Stereotaxis will host a conference call and webcast today, August 12, 2024, at 4:30 p.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 7734844. 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, statements relating to our recent acquisition of APT, including any benefits expected from the acquisition, 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)

 

(in thousands, except share and per share amounts)  Three Months Ended
June 30,
   Six Months Ended
June 30,
 
   2024   2023   2024   2023 
                 
Revenue:                    
Systems  $240   $3,313   $2,852   $5,134 
Disposables, service and accessories   4,262    4,546    8,530    9,273 
Total revenue   4,502    7,859    11,382    14,407 
                     
Cost of revenue:                    
Systems   187    2,703    2,087    4,400 
Disposables, service and accessories   1,002    969    2,016    1,944 
Total cost of revenue   1,189    3,672    4,103    6,344 
                     
Gross margin   3,313    4,187    7,279    8,063 
                     
Operating expenses:                    
Research and development   2,273    2,647    4,516    5,393 
Sales and marketing   3,301    3,340    6,304    6,488 
General and administrative   3,760    3,477    7,226    7,078 
Total operating expenses   9,334    9,464    18,046    18,959 
Operating loss   (6,021)   (5,277)   (10,767)   (10,896)
                     
Other income (expense)   (3)   27    (3)   27 
Interest income, net   191    293    430    565 
Net loss  $(5,833)  $(4,957)  $(10,340)  $(10,304)
Cumulative dividend on convertible preferred stock   (325)   (335)   (656)   (666)
Net loss attributable to common stockholders  $(6,158)  $(5,292)  $(10,996)  $(10,970)
                     
Net loss per share attributed to common stockholders:                    
Basic  $(0.07)  $(0.07)  $(0.13)  $(0.14)
Diluted  $(0.07)  $(0.07)  $(0.13)  $(0.14)
                     
Weighted average number of common shares and equivalents:                    
Basic   84,570,738    81,049,211    84,025,335    78,787,652 
                     
Diluted   84,570,738    81,049,211    84,025,335    78,787,652 

 

 

 

 

STEREOTAXIS, INC.

BALANCE SHEETS

 

(in thousands, except share amounts)  June 30,
2024
   December 31,
2023
 
   (Unaudited)     
Assets          
Current assets:          
Cash and cash equivalents  $14,683   $19,818 
Restricted cash - current   481    525 
Accounts receivable, net of allowance of $640 and $672 at 2024 and 2023, respectively   2,782    3,822 
Inventories, net   9,284    8,426 
Prepaid expenses and other current assets   842    676 
Total current assets   28,072    33,267 
Property and equipment, net   3,059    3,304 
Restricted cash   -    219 
Operating lease right-of-use assets   4,767    4,982 
Prepaid and other non-current assets   116    137 
Total assets  $36,014   $41,909 
           
Liabilities and stockholders’ equity          
Current liabilities:          
Accounts payable  $4,146   $3,190 
Accrued liabilities   2,698    2,972 
Deferred revenue   4,950    6,657 
Current portion of operating lease liabilities   458    428 
Total current liabilities   12,252    13,247 
Long-term deferred revenue   2,121    1,637 
Operating lease liabilities   4,823    5,062 
Other liabilities   54    43 
Total liabilities   19,250    19,989 
           
Series A - Convertible preferred stock:          
Convertible preferred stock, Series A, par value $0.001; 21,683 and 22,358 shares outstanding at 2024 and 2023, respectively   5,408    5,577 
Stockholders’ equity:          
Common stock, par value $0.001; 300,000,000 shares authorized, 82,990,159 and 80,949,697 shares issued at 2024 and 2023, respectively   83    81 
Additional paid-in capital   559,499    554,148 
Treasury stock, 4,015 shares at 2024 and 2023   (206)   (206)
Accumulated deficit   (548,020)   (537,680)
Total stockholders’ equity   11,356    16,343 
Total liabilities and stockholders’ equity  $36,014   $41,909 

 

 

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