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 6, 2020

 

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.)

 

4320 Forest Park Avenue, Suite 100, St. Louis, Missouri   63108
(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 6, 2020, Stereotaxis, Inc. (the “Company”) issued a press release (the “Earnings Press Release”) setting forth its financial results for the 2020 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 6, 2020.

 

 

 

 

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 6, 2020 By: /s/ Kimberly R. Peery
  Name: Kimberly R. Peery
  Title: Chief Financial Officer

 

 

 

 

Exhibit 99.1

 

 

Stereotaxis Reports 2020 Second Quarter Financial Results

 

St. Louis, MO, Aug. 6, 2020 (GLOBE NEWSWIRE) – Stereotaxis (NYSE: STXS), the global leader in innovative robotic technologies for the treatment of cardiac arrhythmias, today reported financial results for the second quarter ended June 30, 2020.

 

“Stereotaxis responded to the challenges of COVID-19 with resilience, prudence and creativity. Despite a 21% year-over-year reduction in quarterly revenue caused by procedure declines, we have made significant progress in commercializing the Genesis RMN® System, advancing strategic innovations, and protecting Stereotaxis’ financial strength,” said David Fischel, Chairman and CEO.

 

“The world’s first Genesis system was installed in July and has successfully treated patients. A second Genesis system is currently being installed. We continue to see significant interest in Genesis and have hosted 198 physicians and hospital administrators from 76 hospitals since April on TeleRobotic visits. Approximately 30% of these represent greenfield opportunities.”

 

“Stereotaxis is pioneering unique TeleRobotic connectivity solutions in electrophysiology and was pleased to host the Inaugural Symposium of the TeleRobotic Surgery Leadership Council. This adds an important new dimension to our operational capabilities and the value of robotics for patients, physicians and hospitals.”

 

“We finalized the design of Stereotaxis’ advanced robotically-navigated magnetic ablation catheter, produced the first batch of catheters with a newly established manufacturing process, and are now testing, refining and validating that process. Meaningful progress has been made on a wave of additional innovations within electrophysiology and beyond.”

 

“We responded prudently to the financial impact of COVID-19 by reducing expenses in a fashion that does not harm organizational capabilities or slow progress. The financing announced during the quarter leaves Stereotaxis in the strongest financial position in its history and reinforces our commitment to invest in impactful innovation and commercial activities.”

 

2020 Second Quarter Financial Results

 

Revenue for the second quarter of 2020 totaled $5.3 million, down 21% compared to $6.8 million in the prior year second quarter. This decrease was primarily due to a 38% reduction in procedure volumes versus the prior year. Procedure volumes improved during the quarter with declines compared to last year of 57% in April, 44% in May, and 13% in June. The impact of this decline on overall revenue was cushioned by the stability of Stereotaxis’ service revenue.

 

Gross margin for the second quarter was $4.3 million, or 80% of revenue. Operating expenses in the quarter of $6.2 million were 13% lower than the prior year second quarter. The reduction in operating expenses was predominantly driven by timing of R&D projects and pandemic-related reductions in sales and marketing activities, partially offset by increased non-cash general and administrative expenses. Operating loss and net loss in the second quarter were ($1.9) million. Negative free cash flow for the quarter was ($1.2) million.

 

Cash Balance and Liquidity

 

At June 30, 2020, Stereotaxis had cash and cash equivalents of $44.0 million.

 

 
 

 

Forward Looking Expectations

 

Stereotaxis expects to recognize revenue on the sale of two Genesis systems in the third quarter, driving year-over-year growth for the quarter. The continued uncertain duration and scope of the COVID-19 pandemic makes it difficult to confidently estimate recurring revenue or the timing of additional system sales. Despite the uncertainty, Stereotaxis continues to experience significant interest in Genesis and expects a resurgence of system sales to existing and new hospital customers as the pandemic recedes.

 

Cash utilization in the second half of the year is expected to be lower than in the first half of the year, and Stereotaxis anticipates ending 2020 with greater than $40 million cash and no debt. Stereotaxis’ 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, August 6, 2020, at 10:00 a.m. Eastern Time. To access the conference call, dial 1-888-394-8218 (US and Canada) or 1-786-789-4776 (International) and give the participant pass code 6170258. 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 is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. 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, improved lab efficiency and productivity, and enhanced integration of procedural information. The core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, Japan, Canada, China, 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 from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to continue to manage expenses and cash burn rate at sustainable levels, continued 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 systems and the timing of such purchases, competitive factors, changes resulting from healthcare policy in the United States, including changes in government reimbursement of procedures, dependence upon third-party vendors, timing of regulatory approvals, the impact of the recent coronavirus (COVID-19) pandemic and our response to it, 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 in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified, delayed or canceled, either by their express terms, as a result of negotiations, or by overall project changes or delays.

 

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 June 30,   Six Months Ended June 30, 
   2020   2019   2020   2019 
Revenue:                
Systems  $12,769   $-   $12,769   $58,051 
Disposables, service and accessories   5,086,156    6,546,115    10,595,867    13,256,873 
Sublease   246,530    251,996    493,060    493,061 
Total revenue   5,345,455    6,798,111    11,101,696    13,807,985 
                     
Cost of revenue:                    
Systems   157,514    6,201    222,536    57,365 
Disposables, service and accessories   680,937    894,760    1,320,800    2,009,119 
Sublease   246,530    246,531    493,060    493,061 
Total cost of revenue   1,084,981    1,147,492    2,036,396    2,559,545 
                     
Gross margin   4,260,474    5,650,619    9,065,300    11,248,440 
                     
Operating expenses:                    
Research and development   1,976,942    2,695,162    4,086,112    5,654,381 
Sales and marketing   2,541,749    3,236,516    5,457,173    6,546,342 
General and administrative   1,663,456    1,178,469    3,496,181    2,646,629 
Total operating expenses   6,182,147    7,110,147    13,039,466    14,847,352 
Operating loss   (1,921,673)   (1,459,528)   (3,974,166)   (3,598,912)
                     
Interest income   567    31,810    81,529    48,374 
Net loss  $(1,921,106)  $(1,427,718)  $(3,892,637)  $(3,550,538)
                     
Cumulative dividend on convertible preferred stock   (342,126)   (357,194)   (685,849)   (710,704)
Loss attributable to common stockholders  $(2,263,232)  $(1,784,912)  $(4,578,486)  $(4,261,242)
                     
Net loss per share attributable to common stockholders:                    
Basic  $(0.03)  $(0.03)  $(0.06)  $(0.07)
Diluted  $(0.03)  $(0.03)  $(0.06)  $(0.07)
                     
Weighted average number of common shares and equivalents:                    
Basic   71,628,762    60,052,673    70,749,401    59,936,606 
Diluted   71,628,762    60,052,673    70,749,401    59,936,606 

 

 
 

 

STEREOTAXIS, INC.

BALANCE SHEETS

 

   June 30, 2020   December 31, 2019 
   (Unaudited)      
Assets          
Current assets:          
Cash and cash equivalents  $44,006,162   $30,182,115 
Accounts receivable, net of allowance of $412,813 and $380,212 at 2020 and 2019, respectively   3,041,100    5,329,577 
          
Inventories, net   4,576,078    1,847,530 
Prepaid expenses and other current assets   1,611,504    1,470,922 
Total current assets   53,234,844    38,830,144 
Property and equipment, net   263,039    250,443 
Operating lease right-of-use assets   3,282,783    4,286,064 
Other assets   269,542    218,103 
Total assets  $57,050,208   $43,584,754 
           
Liabilities and stockholders’ equity          
Current liabilities:          
Short-term debt  $2,158,310   $- 
Accounts payable   1,571,679    2,099,097 
Accrued liabilities   2,401,625    2,721,104 
Deferred revenue   5,456,595    5,092,455 
Current portion of operating lease liabilities   2,265,546    2,248,189 
Total current liabilities   13,853,755    12,160,845 
Long-term deferred revenue   508,772    554,258 
Operating lease liabilities   1,069,090    2,089,537 
Other liabilities   255,517    255,517 
Total liabilities   15,687,134    15,060,157 
           
Series A - Convertible preferred stock:          
Convertible preferred stock, Series A, par value $0.001; 22,813 and 23,110 shares outstanding at 2020 and 2019, respectively   5,682,141    5,758,190 
           
Stockholders’ equity:          
Convertible preferred stock, Series B, par value $0.001; 10,000,000 shares authorized, 5,610,121 shares outstanding at 2020 and 2019   5,610    5,610 
           
Common stock, par value $0.001; 300,000,000 shares authorized, 73,030,824 and 68,529,623 shares issued at 2020 and 2019, respectively   73,031    68,530 
Additional paid in capital   521,013,702    504,211,040 
Treasury stock, 4,015 shares at 2020 and 2019   (205,999)   (205,999)
Accumulated deficit   (485,205,411)   (481,312,774)
Total stockholders’ equity   35,680,933    22,766,407 
Total liabilities and stockholders’ equity  $57,050,208   $43,584,754