-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, HAyVdruGtfqRUkjciJMfTe9mJtUHqajTgLqnuqGbEHlJedq1yzmrUyMXATLfZ2Au z0l57EAaIT0vGJHIEAewJQ== 0001299933-08-001009.txt : 20080225 0001299933-08-001009.hdr.sgml : 20080225 20080225161811 ACCESSION NUMBER: 0001299933-08-001009 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080225 ITEM INFORMATION: Results of Operations and Financial Condition FILED AS OF DATE: 20080225 DATE AS OF CHANGE: 20080225 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ATS MEDICAL INC CENTRAL INDEX KEY: 0000824068 STANDARD INDUSTRIAL CLASSIFICATION: ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES [3842] IRS NUMBER: 411595629 STATE OF INCORPORATION: MN FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-18602 FILM NUMBER: 08639670 BUSINESS ADDRESS: STREET 1: 3905 ANNAPOLIS LA STREET 2: SUITE 105 CITY: MINNEAPOLIS STATE: MN ZIP: 55447 BUSINESS PHONE: 6125537736 MAIL ADDRESS: STREET 1: 3905 ANNAPOLIS LANE STREET 2: SUITE 105 CITY: MINNEAPOLIS STATE: MN ZIP: 55447 FORMER COMPANY: FORMER CONFORMED NAME: ATS MEDCIAL INC DATE OF NAME CHANGE: 19920803 8-K 1 htm_25733.htm LIVE FILING ATS Medical, 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):   February 25, 2008

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

     
Minnesota 0-18602 41-1595629
_____________________
(State or other jurisdiction
_____________
(Commission
______________
(I.R.S. Employer
of incorporation) File Number) Identification No.)
      
3905 Annapolis Lane North, Minneapolis, Minnesota   55447
_________________________________
(Address of principal executive offices)
  ___________
(Zip Code)
     
Registrant’s telephone number, including area code:   763-553-7736

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))


Item 2.02 Results of Operations and Financial Condition.

On February 25, 2008, ATS Medical, Inc. ("ATS" or the "Company") issued a press release to report final financial results for its fourth quarter and fiscal year ended December 31, 2007. The full text of the press release is furnished as Exhibit 99.1 hereto and is incorporated by reference. The information under Item 2.02 in this current report, including the exhibit thereto, is not deemed "filed" for purposes of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.






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.

         
    ATS Medical, Inc.
          
February 25, 2008   By:   Michael R. Kramer
       
        Name: Michael R. Kramer
        Title: Chief Financial Officer


Exhibit Index


     
Exhibit No.   Description

 
99.1
  Press Release of ATS Medical, Inc. dated February 25, 2008
EX-99.1 2 exhibit1.htm EX-99.1 EX-99.1

EXHIBIT 99.1

     
Contacts:
  Investors:
Michael Dale, President/CEO
763-553-7736
Michael Kramer, CFO
  Jenifer Kirtland/Doug Sherk
415-896-6820
Media:
763-557-2222
  Steve DiMattia, 646-201-5445

ATS Medical Announces Record Quarterly and Full Year Revenue
Fourth Quarter 2007 Revenue Increases 32% to $14.2 Million
Gross Profit Margin at 58.2% Sets Quarterly Record

MINNEAPOLIS, MN, February 25, 2008 — ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today reported financial results for the fourth quarter and full year ended December 31, 2007. Revenue for the quarter was $14.2 million, up 32.4% from $10.7 million reported in the fourth quarter of 2006.

Contributing to the strong fourth quarter revenue growth was a 166.7% increase in revenues from the Company’s ATS CryoMaze cryoablation products for the treatment of cardiac arrhythmias. Revenue from this product line rose to $3.6 million. Revenue from the Company’s heart valve therapy products, consisting of mechanical valves, tissue valves and repair products, was up 13.3% on a year-over-year basis to $10.3 million. The growth reflected a 13.5% increase in mechanical valve revenue. Revenue from products and services other than the Company’s mechanical valves represented 33% of total revenue during the fourth quarter of 2007 compared with 21% in the fourth quarter of 2006.

Gross profit margin for the fourth quarter of 2007 set another quarterly record of 58.2% compared with 51.0% for the fourth quarter of 2006, and 56.3% for the third quarter of 2007. The prior record gross margin was 57.8% in the first quarter of 2007.

“Our strong fourth quarter revenue growth and improved gross profit demonstrate continuing progress towards our goal of leadership in cardiac surgery by advancing the standards in the treatment of heart valve disease and cardiac arrhythmias,” said Michael Dale, Chairman, President and Chief Executive Officer. “We have made substantial progress in diversifying our cardiac surgery offerings, while continuing to grow our mechanical heart valve franchise. We are particularly pleased by the increased revenue contribution of our new product lines designed to treat atrial fibrillation and heart valve repair therapies.”

Recent and Upcoming New Product Highlights

Surgical Arrhythmias

    Dr. James Cox – Effective January 1, 2008, Dr. Cox joined ATS Medical as Medical Director. Dr. Cox is a world renowned cardiac surgeon and is regarded as a leading expert in the treatment of atrial fibrillation. During his illustrious career he developed the original cut-and-sew Maze procedure. The original Maze procedure is considered the ‘Gold Standard’ solution for clinical success in the treatment of atrial fibrillation due to the >90% freedom from atrial fibrillation at fifteen years of follow-up. Dr. Cox is leading ATS in the quest to bring the long-term clinical success of his Maze procedure to a minimally invasive approach through the development of new tools and clinical techniques that leverage the ATS CryoMaze technology.

    ATS CryoMaze surgical ablation probes and clamps – Several new products are under development to enhance the utility of the Company’s existing products and tools for the treatment of atrial fibrillation. The Company anticipates launching a next generation ablation clamp and probe in mid 2008.

    Stand Alone Atrial Fibrillation– Over fifteen US centers have performed stand-alone ablation using the existing ATS CryoMaze products. These efforts include a study at East Carolina University where 57 patients have been treated for atrial fibrillation using ATS CryoMaze through minimally invasive access. The results of the study demonstrate over 90% freedom from atrial fibrillation at six months.

Tissue Heart Valves

    ATS 3f® Aortic Bioprosthesis: The Company’s first generation tissue valve has been approved for sale in Europe and Canada and launch activities in these geographies are underway. The ATS 3f Aortic Bioprosthesis represents the Company’s first product targeted at the largest market in cardiac surgery, tissue heart valves.

As announced previously, the Food and Drug Administration (FDA) has asked ATS to provide additional information and clarification in support of its PMA for the ATS 3f Aortic Bioprosthesis. The request relates primarily to in-vitro testing submitted in the original IDE application. The Company intends to work collaboratively with the FDA to answer all questions early in 2008. Management remains confident that the ATS 3f Aortic Bioprosthesis has met or exceeded all of the requirements and is approvable, but it is now anticipated in the second half of 2008.

    ATS 3f Enable Aortic Bioprosthesis: Enrollment in the Company’s European clinical trial of its Enable tissue valve designed to provide a less invasive approach for aortic valve replacement continues to progress with excellent clinical results. The Company expects to reach enrollment of 100 patients in the pivotal stage of the trial around mid year, and anticipates its first regulatory approval for commercialization in 2009.

Mechanical Valves

    ATS Open Pivot AP360™ Mechanical Heart Valve: The Company received FDA approval of its ATS AP360 Heart Valve in December 2007. The AP360 is the Company’s most competitive Open Pivot product, with the same hemodynamic features as its existing supra annular AP valve but with a revised cuff design to enable easier suturing. A limited launch has begun and initial physician experience has been extremely positive. The Company is currently building inventory in preparation for a wider launch in the second quarter.

Repair Products

    ATS Simulus® Semi-Rigid and Adjustable Flexible Rings: Initial launch and implants have been completed and surgeon feedback has been very positive. Both rings have been designed to be easily used with the da Vinci® robotic system from Intuitive Surgical (Nasdaq: ISRG) and minimally invasive repair techniques. Because of the ease of suture placement, the ATS Simulus Flexible rings and bands are fast becoming the annuloplasty device of choice among surgeons performing surgical robotic mitral valve repair.

“We finished 2007 with good momentum and a strong product pipeline that will continue to drive our growth in 2008,” continued Mr. Dale. “Our new development efforts have produced innovative new products designed specifically to improve efficacy for the cardiac surgeon and safety for their patients. As a result, we have made substantial progress on several key milestones – diversifying our revenue sources, leveraging our sales force and enhancing our profit potential. We believe 2008 will be another landmark year for ATS and we look forward to continued growth and enhanced financial performance.”

Additional Financial Results

The operating loss for the fourth quarter was $4.9 million compared with an operating loss of $5.6 million in the fourth quarter of 2006. The net loss for the 2007 fourth quarter was $6.2 million, or $0.10 per share, compared with $6.1 million, or $0.15 per share in the fourth quarter of 2006.

Full Year 2007 Results

For the full year 2007, revenue totaled $49.6 million, 22.6% above 2006 revenue of $40.4 million. The Company reported a net loss for 2007 of $23.0 million, or $0.44 per share, compared to a net loss of $27.7 million, or $0.83 per share, in 2006. The net loss for 2007 included charges for acquired in-process research and development of $3.5 million related to the CryoCath asset acquisition and $0.8 million related to discontinuance of the PARSUS development program. The net loss for 2006 included a charge for acquired in-process research and development of $14.4 million related to the acquisition of 3f Therapeutics.

2008 Outlook

For the full year 2008 the Company expects revenue to grow approximately 21% to 29% from 2007 to a range of $60 to $64 million. The Company continues to expect to generate a profit in the fourth quarter of 2008.

Conference Call Today

ATS management will host a conference call today, February 25, 2008 at 5:00 p.m. ET to discuss its fourth quarter financial results and current corporate developments. The dial-in number for the conference call is 800-218-4007 for domestic participants and 303-262-2142 for international participants. A live webcast of the call can also be accessed at www.atsmedical.com by clicking on the Investors icon.

A taped replay of the conference call will also be available beginning approximately one hour after the call’s conclusion and will remain available for seven days. The replay can be accessed by dialing 800-405-2236 for domestic participants and 303-590-3000 for international callers, using the passcode 11109130#.

About ATS Medical

ATS Medical, Inc. provides innovative products and services focused on cardiac surgery. The company, global in scope, is headquartered in Minneapolis, Minnesota. More than 145,000 ATS Open Pivot® Heart Valves, which utilize a unique pivot design resulting in exceptional performance and low risk profile, have been implanted in patients worldwide. The ATS 3f® brand encompasses multiple tissue heart valve product offerings at varying steps from market introductions to clinical trials to development projects that incorporate less invasive valve replacement technology. ATS Medical’s focus on serving the cardiac surgery community is further strengthened by offerings that include ATS Simulus® annuloplasty products for heart valve repair and ATS CryoMaze surgical ablation products. The ATS Medical web site is http://www.atsmedical.com.

Safe Harbor

This Press Release contains forward-looking statements that may include statements regarding intent, belief or current expectations of the Company and its management. Actual results could differ materially from those projected in the forward looking statements as a result of a number of important factors, including the results of clinical trials, the timing of regulatory approvals, the integration of 3f Therapeutics and the surgical cryoablation business of CryoCath Technologies, Inc., regulatory actions, competition, pricing pressures, supplier actions and management of growth. For a discussion of these and other risks and uncertainties that could affect the Company’s activities and results, please refer to the Company’s filings with the Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2006 and its most recent quarterly report on Form 10-Q.

1

                                 
ATS Medical, Inc.     
Condensed Consolidated Statements of Operations     
(in thousands except per share amounts)    
    Three Months Ended   Year Ended
    December 31,   December 31,
    2007   2006   2007   2006
Net sales
  $ 14,217     $ 10,740     $ 49,587     $ 40,449  
Cost of goods sold
    5,937       5,266       21,348       19,568  
 
                               
Gross profit
    8,280       5,474       28,239       20,881  
 
                               
Operating expenses:
                               
Sales and marketing
    7,019       5,851       24,633       21,008  
Research and development
    2,173       2,011       7,546       3,381  
In-process research and development
                3,500       14,400  
Distributor termination expense
          657             733  
General and administrative
    3,099       2,498       10,417       8,786  
Amortization of intangibles
    885       106       2,516       106  
Intangible asset impairment
                755        
 
                               
Total operating expenses
    13,176       11,123       49,367       48,414  
 
                               
Operating loss
    (4,896 )     (5,649 )     (21,128 )     (27,533 )
 
                               
 
                               
Interest expense, net
    (555 )     (434 )     (1,822 )     (1,669 )
Other income (expense)
    (594 )     3       61       1,528  
 
                               
 
                               
Net loss before income taxes
    (6,045 )     (6,080 )     (22,889 )     (27,674 )
Income tax expense
    116             119        
 
                               
Net loss
    ($6,161 )     ($6,080 )     ($23,008 )     ($27,674 )
 
                               
 
                               
Net loss per share:
                               
Basic and diluted
    ($0.10 )     ($0.15 )     ($0.44 )     ($0.83 )
 
                               
 
                               
Weighted average number of shares outstanding:
                               
Basic and diluted
    59,412       40,304       52,589       33,537  
 
                               

2

                 
ATS Medical, Inc.        
Condensed Consolidated Balance Sheets        
(in thousands)        
    December 31,   December 31,
    2007   2006
Assets
               
Cash and short-term investments
  $ 14,669     $ 10,704  
Accounts receivable
    11,186       11,677  
Inventories
    18,743       18,782  
Prepaid expenses
    1,143       1,175  
 
               
Total current assets
    45,741       42,338  
 
               
Property and equipment, net
    7,739       8,213  
Intangible assets
    50,779       33,155  
Other assets
    1,638       2,134  
 
               
Total assets
  $ 105,897     $ 85,840  
 
               
 
               
 
               
Liabilities & shareholders’ equity
               
Accounts payable
  $ 4,794     $ 3,183  
Accrued compensation
    2,361       2,589  
Other accrued liabilities
    2,000       2,457  
Current maturities of bank notes payable
    2,457       1,133  
Warrant liability
    3,913        
 
               
Total current liabilities
    15,525       9,362  
 
               
Convertible senior notes payable
    17,436       17,394  
Bank notes payable
    6,143       1,194  
Payable to CryoCath Technologies Inc.
    1,742        
Deferred income taxes
    95        
 
               
Shareholders’ equity
    64,956       57,890  
 
               
Total liabilities & shareholders’ equity
  $ 105,897     $ 85,840  
 
               

3

                 
ATS Medical, Inc.    
Consolidated Condensed Statements of Cash Flow    
(in thousands)    
    Year Ended December 31,
    2007   2006
Operating activities
               
Net loss
    ($23,008 )     ($27,674 )
Adjustments to reconcile net loss to net cash
               
used in operating activities:
               
Depreciation and amortization
    4,622       1,924  
Loss on disposal of equipment
          26  
Stock compensation expense
    1,454       1,103  
Acquired in-process research and development
    3,500       14,400  
Impairment of intangibles
    755        
Deferred income taxes
    95        
Non-cash interest expense
    546       463  
Change in value of common stock appreciation rights and convertible senior notes derivative liabilities
    554       (1,528 )
Changes in operating assets and liabilities
    1,939       1,456  
 
               
Net cash used in operating activities
    (9,543 )     (9,830 )
 
               
Investing activities
               
Maturities (purchases) of short-term investments, net
    1,903       (990 )
Acquisition of assets of CryoCath Technologies Inc.
    (21,074 )      
Business acquisition costs, net of cash acquired
    (1,791 )     (717 )
Payments for technology licenses and other intangibles
    (277 )     (521 )
Purchases of furniture, machinery and equipment
    (748 )     (1,208 )
Other
    (36 )      
 
               
Net cash used in investing activities
    (22,023 )     (3,436 )
 
               
Financing activities
               
Advances on bank notes payable
    8,600       1,500  
Repayments on bank notes payable
    (2,327 )     (909 )
Net proceeds from sales of common stock and warrants
    31,196       123  
Other
    168        
 
               
Net cash provided by financing activities
    37,637       714  
 
               
Other items
    (203 )     544  
 
               
 
               
Increase (decrease) in cash and cash equivalents
  $ 5,868       ($12,008 )
 
               

   

4

                                 
ATS Medical, Inc.        
Selected Revenue Information        
(in thousands)        
    Revenue for the Three Months   Revenue for the Year
    Ended December 31,   Ended December 31,
    2007   2006   2007   2006
 
                               
Heart valve therapy
  $ 10,336     $ 9,122     $ 38,558     $ 35,343  
Surgical arrhythmias
    3,576       1,341       9,689       4,554  
Surgical tools & accessories
    305       277       1,340       552  
 
                               
Total revenue
  $ 14,217     $ 10,740     $ 49,587     $ 40,449  
 
                               

   

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