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 8, 2019

 

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 (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))

 

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. [  ]

 

 

 

   
   

 

Item 2.02 Results of Operations and Financial Condition

 

On August 8, 2019, Stereotaxis, Inc. (the “Company”) issued a press release (the “Earnings Press Release”) setting forth its financial results for the 2019 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 8, 2019.

 

   
   

 

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 8, 2019 By: /s/ Martin C. Stammer
  Name: Martin C. Stammer
  Title:  Chief Financial Officer

 

   
   

 

 

Exhibit 99.1

 

 

 

Stereotaxis Reports 2019 Second Quarter Financial Results

 

ST. LOUIS, MO, August 8, 2019 – Stereotaxis (OTCQX: 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, 2019. In a separate press release issued concurrently with this release, Stereotaxis announced a $25 million private placement equity financing.

 

“The second quarter was an exciting period for Stereotaxis and a pivotal turning point in our effort to reestablish a long-term growth trajectory,” said David Fischel, Chairman and CEO. “Since showcasing our innovation accomplishments and strategy at the Heart Rhythm Society conference in May, many existing and potential customers have visited our headquarters to view our innovations first hand. The broad, enthusiastic response validates that our innovation and strategic decisions were sound and that our plan is medically and commercially attractive. We are confident in our expectation for significant revenue growth in the years ahead.”

 

As mentioned previously, in the second quarter Stereotaxis announced several innovation accomplishments and programs:

 

  Stereotaxis Genesis™ RMN System – initial launch of a next generation robotic system that is designed to provide the established benefits and reliability of robotic magnetic navigation in an architecture that is faster, smaller, lighter and more flexible.
  Stereotaxis Imaging Model S – launch of an advanced x-ray imaging solution offered in combination with Stereotaxis Genesis RMN to increase the accessibility and affordability of robotics in electrophysiology.
  Proprietary Magnetic Ablation Catheter – development program proceeding on an advanced next-generation robotically-navigated magnetic ablation catheter.
  Acutus Mapping Integration & OpenMappingAPI – integration with Acutus’ novel mapping system was successfully accomplished using a software architecture that facilitates a more open, collaborative environment.

 

David Fischel continued, “With the financing announced today, Stereotaxis has the financial strength to accelerate the development and commercial introduction of these innovations, as well as to fund a second wave of innovations in electrophysiology and beyond.”

 

Second Quarter 2019 Financial Results

 

Revenue for the second quarter of 2019 totaled $6.8 million compared to $7.6 million in the prior year second quarter. This decrease was primarily due to reduced service revenue from system moves as well as certain inactive accounts that have aged and no longer maintain active service contracts, partially offset by a modest increase in procedure volume compared to the prior year second quarter.

 

   
 

 

Gross margin in the quarter was 83% of revenue, consistent with the 82% reported in the second quarter of 2018. Operating expenses in the second quarter of $7.1 million increased from $6.8 million in the prior year quarter. The increase in operating expenses reflects significantly increased investment in research and development with reduced general, administrative and selling expenses.

 

Operating loss and net loss in the second quarter were ($1.5) million and ($1.4) million, respectively, compared to ($0.6) million for both in 2018. Negative free cash flow for the quarter was ($0.5) and was consistent with previously provided guidance for 2019.

 

Cash Balance and Liquidity

 

At June 30, 2019, Stereotaxis had cash and cash equivalents of $8.5 million and no debt. Pro forma, including the financing announced today and deducting financing related fees and expenses, Stereotaxis would have held approximately $31.6 million in cash and cash equivalents as of June 30, 2019 with a stockholders’ equity balance of $21.8 million.

 

Full Year 2019 Expectations

 

Stereotaxis’ innovation accomplishments support an expectation of robust and consistent overall revenue growth beginning in the coming quarters and accelerating throughout 2020.

 

Without considering the financing announced today, Stereotaxis would have reiterated its expectation to end 2019 with greater than $6.0 million in net cash and to reach profitability without the need for additional capital.

 

Conference Call and Webcast

 

Stereotaxis will host a conference call and webcast today, August 8, 2019, at 9:00 a.m. Eastern Time. To access the conference call, dial 1-800-353-6461 (US and Canada) or 1-334-323-0501 (International) and give the participant pass code 2198862. 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. Stereotaxis’ robotic technology has received various regulatory clearances in the United States, European Union, Japan, Canada, China, and elsewhere. The Stereotaxis Genesis RMN System is CE marked and will become available in other global geographies subject to regulatory approvals. Stereotaxis Imaging Model S is CE marked and FDA cleared. 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 raise additional capital on a timely basis and on terms that are acceptable, its ability to continue to manage expenses and cash burn rate at sustainable levels, its ability to continue to work with lenders to extend, repay or refinance indebtedness, or to obtain additional financing, in either case on acceptable terms, 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 reform in the United States, including changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approvals, 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

 

Martin C. Stammer

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,
 
   2019   2018   2019   2018 
                 
Revenue:                    
Systems  $-   $310,751   $58,051   $328,026 
Disposables, service and accessories   6,546,115    7,240,650    13,256,873    14,195,008 
Sublease   251,996    -    493,061    - 
Total revenue   6,798,111    7,551,401    13,807,985    14,523,034 
                     
Cost of revenue:                    
Systems   6,201    457,509    57,365    661,111 
Disposables, service and accessories   894,760    931,541    2,009,119    1,993,286 
Sublease   246,531    -    493,061    - 
Total cost of revenue   1,147,492    1,389,050    2,559,545    2,654,397 
                     
Gross margin   5,650,619    6,162,351    11,248,440    11,868,637 
                     
Operating expenses:                    
Research and development   2,695,162    2,032,394    5,654,381    3,995,020 
Sales and marketing   3,236,516    3,457,416    6,546,342    7,092,413 
General and administrative   1,178,469    1,298,604    2,646,629    2,537,783 
Total operating expenses   7,110,147    6,788,414    14,847,352    13,625,216 
Operating loss   (1,459,528)   (626,063)   (3,598,912)   (1,756,579)
                     
Other income   -    -    -    2,590,361 
Interest income (expense)   31,810    (6,142)   48,374    (30,757)
Net income (loss)  $(1,427,718)  $(632,205)  $(3,550,538)  $803,025 
Cumulative dividend on convertible preferred stock   (357,194)   (357,518)   (710,704)   (711,107)
Net income attributable to convertible preferred stock   -         -    (42,936)
Net income (loss) attributable to common stockholders  $(1,784,912)  $(989,723)  $(4,261,242)  $48,982 
                     
Net income (loss) per share attributed to common stockholder:                    
Basic  $(0.03)  $(0.02)  $(0.07)  $0.00 
Diluted  $(0.03)  $(0.02)  $(0.07)  $0.00 
                     
Weighted average number of common shares and equivalents:                    
Basic   60,052,673    58,926,545    59,936,606    45,019,358 
Diluted   60,052,673    58,926,545    59,936,606    45,728,732 

 

   
 

 

STEREOTAXIS, INC.

BALANCE SHEETS

 

   June 30, 2019   December 31, 2018 
   (Unaudited)     
Assets          
Current assets:          
Cash and cash equivalents  $8,471,914   $10,796,072 
Accounts receivable, net of allowance of $502,251 and $398,847 in 2019 and 2018, respectively   4,997,148    5,021,111 
Inventories, net   1,560,116    1,191,666 
Prepaid expenses and other current assets   514,408    963,700 
Total current assets   15,543,586    17,972,549 
Property and equipment, net   297,494    343,693 
Operating lease right-of-use assets   5,245,842    - 
Other assets   168,153    198,365 
Total assets  $21,255,075   $18,514,607 
           
Liabilities and stockholders' equity (deficit)          
Current liabilities:          
Accounts payable  $1,642,049   $1,726,360 
Accrued liabilities   2,376,058    2,642,481 
Deferred revenue   6,537,988    5,825,536 
Current portion of operating lease liabilities   2,223,023    - 
Total current liabilities   12,779,118    10,194,377 
           
Long-term deferred revenue   508,772    407,151 
Operating lease liabilities   3,048,650    - 
Other liabilities   260,947    641,461 
Total liabilities   16,597,487    11,242,989 
           
Convertible preferred stock:          
Convertible preferred stock, par value $0.001; 10,000,000 shares authorized, 23,855 and 23,900 shares outstanding at 2019 and 2018   5,948,953    5,960,475 
Stockholders' equity (deficit):          
Common stock, par value $0.001; 300,000,000 shares authorized, 59,383,038 and 59,058,297 shares issued at 2019 and 2018, respectively   59,383    59,058 
Additional paid-in capital   479,127,279    478,179,574 
Treasury stock, 4,015 shares at 2019 and 2018   (205,999)   (205,999)
Accumulated deficit   (480,272,028)   (476,721,490)
Total stockholders' equity (deficit)   (1,291,365)   1,311,143 
Total liabilities and stockholders' equity (deficit)  $21,255,075   $18,514,607