Stereotaxis, Inc. (Form: 8-K)  

 


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 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):   May 9, 2007

Stereotaxis, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)

     
Delaware 000-50884 94-3120386
_____________________
(State or other jurisdiction
_____________
(Commission
______________
(I.R.S. Employer
of incorporation) File Number) Identification No.)
      
4320 Forest Park Avenue, St. Louis, Missouri   63108
_________________________________
(Address of principal executive offices)
  ___________
(Zip Code)
     
Registrant’s telephone number, including area code:   (314) 615-6940

Not Applicable
______________________________________________
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))


Top of the Form

Item 1.01 Entry into a Material Definitive Agreement.

On May 5, 2007, Stereotaxis, Inc. (the "Company") entered into an Alliance Expansion Agreement with Biosense Webster, Inc. ("Biosense"). The Alliance Expansion Agreement amends the Development Alliance and Supply Agreement dated as of May 7, 2002, as amended pursuant to the Amendment to Development and Supply Agreement dated as of November 3, 2003, to expand the strategic alliance to integrate technology platforms, specifically the Stereotaxis Niobe System and the Biosense Webster CARTO mapping and localization system. The Alliance Expansion Agreement extends the current worldwide agreement for the development and distribution of magnetically enabled irrigated tip catheters by two years, through December 31, 2011. Additionally, beyond electrophysiology, the two companies have agreed to explore opportunities for expanding their integrated technology for the delivery of cells and other biological agents for the treatment of heart failure.





Item 2.02 Results of Operations and Financial Condition.

On May 9, 2007, the Company issued a press release setting forth its financial results for the first quarter of fiscal 2007. A copy of the press release is being filed as Exhibit 99.1 hereto, and the statements contained therein are incorporated by reference herein.

In accordance with General Instruction B.2 of Form 8-K, the information contained in this Item 2.02 and the Exhibit 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 7.01 Regulation FD Disclosure.

On May 9, 2007, the Company and Biosense issued a joint press release announcing the entry into the Alliance Expansion Agreement described in Item 1.01 above. A copy of this press release is attached hereto as Exhibit 99.2.

The information furnished in this Item 7.01 (including the press release attached as Exhibit 99.2) is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities and Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing. In addition, this report (including the press release attached as Exhibit 99.2) shall not be deemed an admission as to the materiality of any information contained herein that is required to be disclosed solely as a requirement of this Item.





Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

99.1 Press release dated May 9, 2007 (announcing earnings).
99.2 Press release dated May 9, 2007 (announcing Alliance Expansion Agreement)







Top of the Form

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.
          
May 9, 2007   By:   James M. Stolze
       
        Name: James M. Stolze
        Title: Vice President and Chief Financial Officer


Top of the Form

Exhibit Index


     
Exhibit No.   Description

 
99.1
  Press Release dated May 9, 2007 (announcing earnings)
99.2
  Press Release dated May 9, 2007 (announcing Alliance Extension Agreement)
EX-99.1

[Stereotaxis letterhead]

Contacts:

     
Stereotaxis, Inc.
  Russo Partners, LLC
 
   
314-678-6105
  212-845-4235
 
   
Jim Stolze, Chief Financial Officer
  Matthew Haines (investors)
 
   
jstolze@stereotaxis.com
  matthew.haines@russopartnersllc.com

STEREOTAXIS ANNOUNCES RECORD FIRST QUARTER RESULTS

Management to Host Conference Call Today at 8:30 AM Eastern Daylight Time

St. Louis, MO, May 9, 2007 – Stereotaxis, Inc. (NASDAQ: STXS) today reported revenue of $9.2 million for the quarter ended March 31, 2007, greater than a fourfold increase over the revenue of $1.7 million for the first quarter of 2006.

System revenue amounted to $7.2 million in the first quarter of 2007 compared to $1.0 million in the prior year quarter as a result of the increase in the number of systems recognized. The average system price realized increased approximately 22 percent in the 2007 quarter compared to the 2006 quarter. Disposables, service and accessories revenue increased to $2.0 million from $749,000 in the prior year quarter. Gross profit amounted to $5.9 million in the current quarter, resulting in a 65 percent gross margin for the 2007 quarter, compared to $500,000, or a 29 percent margin for the 2006 quarter. As of March 31, 2007, Stereotaxis had delivered 72 Niobe systems worldwide.

First quarter operating expenses were approximately $16.7 million, compared to $15.0 million incurred during the first quarter of 2006. The increase was primarily attributed to increased salary, benefits and travel expenses associated with expanded sales headcount, offset by lower research and development costs compared to the prior year quarter.

Net loss for the first quarter ended March 31, 2007 was approximately $10.5 million, compared to $14.6 million reported in the prior year quarter. Net loss per diluted share for the current quarter was $0.31 compared to the $0.47 loss reported for the prior year quarter. Diluted earnings per share were based on 34.4 million and 31.2 million weighted average shares outstanding, respectively, for the two quarters. The change in weighted average shares relates primarily to the issuance of 1.9 million shares in the Company’s sale of common stock in a registered direct offering completed in March 2007 pursuant to a shelf registration and the exercise of warrants during 2006.

At March 31, 2007, Stereotaxis had purchase orders and other commitments for its Niobe® systems of approximately $49 million. The Company does not include orders for disposables, service or accessories in its backlog data. These purchase orders and commitments are subject to contingencies that are outside our control and may be revised, modified or canceled.

“We are very pleased with the performance of the Company in the first quarter of 2007. With approximately $11 million in new orders and total revenue for the quarter of $9.2 million, we have established the foundation for our expected 2007 full year objectives”, commented Bevil Hogg, Chief Executive Officer of Stereotaxis. “We are also excited about the recent approvals of the eight millimeter catheter in the U.S. and receipt of the CE Mark for the irrigated catheter, leaving only the FDA approval of the irrigated catheter to provide a full complement of ablation catheters to clinicians worldwide. We look forward to another exciting Heart Rhythm Society meeting beginning tomorrow, and believe that the scheduled symposium and other activities will further demonstrate advantages of the Stereotaxis Niobe system.”

Stereotaxis ended the first quarter with cash and investments of approximately $49.4 million, as compared to approximately $37.0 million at year-end 2006. Total debt at March 31, 2007 amounted to approximately $1.7 million.

The Company continues to expect that total revenue for the year ending December 31, 2007 will be in the range of 90 percent to more than 100 percent greater than the $27.2 million recorded in the year ended December 31, 2006. To reiterate, Stereotaxis’ sales cycle, similar to other companies selling capital equipment to hospitals, is relatively long and can be subject to lumpiness from quarter to quarter, as hospital budget decisions and equipments installation schedules are often subject to last-minute delays. Prudence dictates that investors should anticipate the occasional impact on the Company’s quarterly results of such unexpected delays.

The Company will host a conference call today at 8:30 a.m. Eastern Daylight Time to discuss the results for the quarter. To participate in the conference call, please dial 888.868.9083 (Domestic) or 973.935.8512 (International) a few minutes before 8:30 a.m. ET. A replay of the conference call will be available from 10:30 a.m. ET on May 9, 2007 until 9:30 a.m. p.m. ET on May 16, 2007. The replay dial in number is 877.519.4471 (Domestic) or 973.341.3080 (International). The replay pin number is 8739988.

The call will also be available on the Internet live and for 90 days thereafter at the following URL:

http://www.videonewswire.com/event.asp?id=39485

About Stereotaxis

Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital’s interventional surgical suite to enhance the treatment of arrhythmias and coronary artery disease. The Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe and Canada.

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, continued acceptance of the Company’s products in the marketplace, competitive factors, changes in government reimbursement procedures, dependence upon third-party vendors, 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 we will recognize revenue related to our 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 our control. In addition, these orders and commitments may be revised, modified or canceled, either by their express terms, as a result of negotiations, or by project changes or delays.

1

STEREOTAXIS, INC.
STATEMENTS OF OPERATIONS
(Unaudited)
 

                                 
    Three Months Ended        
    March 31,        
    2007           2006        
Systems revenue
  $ 7,207,443             $ 982,597          
Disposables, service and accessories revenue
    1,953,512               749,196          
 
                               
Total revenue
    9,160,955               1,731,793          
Cost of revenue
    3,250,348               1,231,991          
 
                               
Gross margin
    5,910,607               499,802          
Operating expenses:
                               
Research and development
    5,694,691               6,129,870          
General and administration
    4,942,935               4,019,751          
Sales and marketing
    6,079,923               4,873,377          
 
                               
Total operating expenses
    16,717,549               15,022,998          
 
                               
Operating loss
    (10,806,942 )             (14,523,196 )        
Interest income
    382,454               480,992          
Interest expense
    (79,617 )             (553,102 )        
 
                               
Net loss
  $ (10,504,105 )           $ (14,595,306 )        
 
                               
Net loss per common share:
                               
Basic and diluted
  $ (0.31 )           $ (0.47 )        
 
                               
Weighted average shares used in computing net loss per common share:
                               
Basic and diluted
    34,409,573               31,155,200          
 
                               

2

STEREOTAXIS, INC.
BALANCE SHEETS
 

                                 
    March 31, 2007           December 31, 2006        
    (Unaudited)                        
Assets
                               
Current Assets:
                               
Cash and cash equivalents
  $ 46,444,382             $ 15,210,493          
Short-term investments
    2,993,211               21,773,288          
Accounts receivable, net of allowance of $91,514 and $90,716 in 2007 and 2006, respectively
    11,849,893               15,280,628          
Current portion of long-term receivables
                  163,362          
Inventories
    10,019,323               8,285,825          
Prepaid expenses and other current assets
    1,635,426                          
 
                               
Total current assets
    72,942,235               63,294,369          
Property and equipment, net
    5,395,515               4,130,295          
Intangible assets, net
    1,511,111               1,544,444          
Long-term receivables
    400,740                        
Other assets
    316,410               321,552          
 
                               
Total assets
  $ 80,566,011             $ 69,290,660          
 
                               
Liabilities and stockholders’ equity
                               
Current liabilities:
                               
Current maturities of long-term debt
  $ 1,500,000             $ 1,666,666          
Accounts payable
    5,030,490               5,555,121          
Accrued liabilities
    11,030,310               10,025,231          
Deferred contract revenue
    5,058,903               5,663,553          
 
                               
Total current liabilities
    22,619,703               22,910,571          
Long term debt, less current maturities
    222,223               305,556          
Long term deferred contract revenue
    1,098,612               1,220,174          
Other liabilities
    459,908               65,367          
Stockholders’ equity:
                               
Preferred stock, par value $0.001; 10,000,000 shares authorized at 2007 and 2006; none outstanding at 2007 and 2006
                           
Common stock, par value $0.001; 100,000,000 shares authorized at 2007 and 2006; 36,846,794 and 34,755,397 issued at 2007 and 2006, respectively
    36,847               34,755          
Additional paid-in capital
    270,789,228               248,908,918          
Treasury stock, 40,151 shares at 2007 and 2006
    (205,999 )             (205,999 )        
Accumulated deficit
    (214,454,944 )             (203,950,839 )        
Accumulated other comprehensive gain/(loss)
    433               2,157          
 
                               
Total stockholders’ equity
    56,165,565               44,788,992          
 
                               
Total liabilities and stockholders’ equity
  $ 80,566,011             $ 69,290,660          
 
                               

3

EX-99.2

[Stereotaxis logo] [Biosense logo]

     
FOR IMMEDIATE RELEASE    
Contacts:
  Kim Thompson

Biosense Webster, Inc.

(o) 909-839-8553

(m) 909-967-0039

kthomps5@bwius.jnj.com

Jim Stolze

Stereotaxis Inc.

(o) 314-678-6105

jstolze@stereotaxis.com

Biosense Webster and Stereotaxis Expand Strategic Alliance
and Extend Current Agreement

DIAMOND BAR, Calif., and ST. LOUIS, Mo. – May 9, 2007 – Biosense Webster, Inc., and Stereotaxis, Inc. (NASDAQ:STXS) today announced an expanded strategic alliance to integrate technology platforms, specifically the Stereotaxis Niobe System and the Biosense Webster Carto® EP Navigation System. The two companies also extended by two years the current worldwide agreement for the development and distribution of magnetically enabled irrigated tip catheters. The two-year extension runs through December 31, 2011.

“Through our alliance with Stereotaxis, together we can continue developing breakthrough technology for the millions of patients with arrhythmias,” said Roy Tanaka, Worldwide President, Biosense Webster. “We believe that computer guided magnetic navigation is beneficial in the treatment of arrhythmias and look forward to continuing our partnership with Stereotaxis to advance patient care.”

The agreement, which is focused on integration of cath lab systems and the computer guided delivery of magnetic devices, is intended to bring additional improvements in efficiency, efficacy and safety to interventional electrophysiology procedures.

“This expanded collaboration enables Stereotaxis to secure the advantages of the Biosense Webster irrigated catheter for an extended period and evidences the commitment the two companies have to continue development and distribution of this leading-edge technology to electrophysiology suites around the world,” said Bevil Hogg, Chief Executive Officer, Stereotaxis, Inc.

Additionally, beyond electrophysiology, the two companies have agreed to explore opportunities for expanding their integrated technology for the delivery of cells and other biological agents for the treatment of heart failure.

The companies will launch their expanded collaboration during a joint symposium at Heart Rhythm 2007, the Heart Rhythm Society’s 28th Annual Scientific Sessions, which will be held May 9-12 in Denver.

About Biosense Webster
Biosense Webster Inc, a Johnson & Johnson Company, pioneered EP diagnostic catheters more than 30 years ago and continues to lead the industry as an innovative provider of advanced diagnostic, therapeutic, and mapping tools. As the leader in navigation systems, Biosense Webster’s technology includes the largest installed base of navigation systems worldwide in leading hospitals and teaching institutions. With proprietary products such as the Carto® XP System, the CartoSound Image Integration Software Module, the ThermoCool® Irrigated Tip Catheter and the Lasso® Circular Variable Mapping Catheter, the company is changing the way electrophysiologists diagnose and treat arrhythmias.

About Stereotaxis
Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital’s interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. The core components of the Stereotaxis System have received regulatory clearance in the United States, Europe and Canada.

About the Heart Rhythm Society
Heart Rhythm 2007 is the most comprehensive educational program for heart rhythm professionals, featuring over 200 educational sections and more than 130 innovative products and services. This year, the meeting will open with the AFib Summit, a two-day intensive summit on atrial fibrillation featuring world-renowned experts. The Heart Rhythm Society’s Annual Scientific Sessions have become the must-attend event of the year, allowing the exchange of new vital ideas and information among colleagues from every corner of the globe.

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