-----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, HEhM+3YeTIsKcyAruRMYIOHEKd9/DHmxZ/eSiEI4Xw9Yo3b4/v1Np0rRCeEJ1HLU ABvvFSWcDik3GuFUTV7wbw== 0000950137-07-007110.txt : 20070509 0000950137-07-007110.hdr.sgml : 20070509 20070509163344 ACCESSION NUMBER: 0000950137-07-007110 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070509 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070509 DATE AS OF CHANGE: 20070509 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: 07832921 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 c15148e8vk.htm CURRENT REPORT e8vk
 

 
 
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: May 9, 2007
(date of earliest event reported)
ATS MEDICAL, INC.
(Exact name of registrant as specified in its charter)
Commission File Number: 0-18602
 
     
Minnesota
(State or other jurisdiction of incorporation)
  41-1595629
(IRS Employer Identification No.)
3905 Annapolis Lane North, Suite 105
Minneapolis, Minnesota 55447

(Address of Principal Executive Offices)
(763) 553-7736
(Registrant’s telephone number, including area code)
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 (see General Instruction A.2. below):
    o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
    o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
    o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
    o 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 May 9, 2007, ATS Medical, Inc. (the “Company”) issued a press release to report final financial results for its first quarter ended March 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.
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits
      99.1 Press Release dated May 9, 2007, of ATS Medical, Inc.

 


 

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.
 
 
  By:   /s/ Michael R. Kramer  
    Michael R. Kramer   
    Acting Chief Financial Officer   
 
Date: May 9, 2007

 


 

EXHIBIT INDEX
       
Exhibit No.   Description
99.1
  Press Release, dated May 9, 2007, of ATS Medical, Inc.

 

EX-99.1 2 c15148exv99w1.htm PRESS RELEASE exv99w1
 

EXHIBIT 99.1
(ATS MEDICAL LOGO)
Contacts:    
     
Michael Dale, President/CEO   Investors:
763-553-7736   Jennifer Beugelmans, 646-201-5447
Michael Kramer, Acting CFO   Doug Sherk, 415-896-6820
763-557-2222   Steve DiMattia, 646-201-5445 (Media)
ATS Medical’s First Quarter Results Include Record Gross Profit
First Quarter Revenue Increases 11% Year-Over-Year
Surgical Arrhythmia Therapy Revenue Grows 40% Year-Over-Year
First Generation Tissue Heart Valve Limited Launch Planned for Second Quarter
MINNEAPOLIS, May 9, 2007 — ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today reported financial results for the first quarter of 2007. Revenue for the quarter was $10.8 million, up 11.0% from $9.7 million reported in the first quarter of 2006.
Revenue generated from the Company’s surgical arrhythmia therapy products increased 39.6% year-over-year to $1.5 million. Revenue from the Company’s heart valve therapy product lines, consisting of mechanical heart valves, tissue heart valves and repair products, increased 4.2% year-over-year to $9.0 million. Revenues from products and services other than the Company’s mechanical heart valves represented 22.9% of total revenue during the first quarter of 2007 compared with 21.5% in the fourth quarter of 2006 and 14.3% in the first quarter of 2006.
Gross profit as a percent of net sales for the first quarter of 2007 increased to 57.8% from 51.0% for the fourth quarter of 2006 and 48.6% in the first quarter of 2006. Included in cost of goods sold in the first quarter of 2007 were manufacturing expenses of approximately $227,000 related to unabsorbed costs at the Company’s tissue valve facility due to low production volumes.
The operating loss for the first quarter was $4.4 million compared with an operating loss of $2.4 million in the first quarter of 2006. Operating loss for the first quarter of 2007 included non-recurring severance expense of $439,000 and $415,000 of amortization related to the Company’s 3F acquisition and its technology license agreement with CarboMedics. The net loss for the first quarter of 2007 was $4.8 million, or $0.11 per share, compared with a net loss of $1.6 million, or $0.05 per share, in the first quarter of 2006. The net loss for the first quarter of 2006 included a $1.2 million gain related to a change in valuation of derivatives.
“The solid revenue growth and improved gross profit for the first quarter highlight the increased contribution from new products and continued execution of our strategy to reduce manufacturing costs,” commented Michael Dale, Chairman and Chief Executive Officer. “Our gross profit margin improvement reflects the benefits of our revenue diversification strategy, our efforts to reduce our manufacturing costs and leverage our infrastructure.

 


 

“During the second quarter we expect to achieve continued revenue growth across all product lines.” continued Mr. Dale. “On the clinical front, we are pleased to announce we’ve launched the pivotal study of our Enable sutureless tissue valve in April beginning with clinical implants outside the US. We are still targeting to begin our US IDE for Enable sometime in the next few months.”
At March 31, 2007, the Company had cash and short-term investments of $21 million. Included in the cash and short-term investments were $15.4 million in net proceeds from the Company’s March 2007 private placement of 8,125,000 shares of common stock.
2007 Outlook
The Company expects full-year 2007 revenue of $46 to $47 million, which reflects year-over-year growth of 13.5% to 16%. Gross profit margin for the year is expected to be in the 60% range.
Conference Call Today
ATS management will host a conference call today, May 9, 2007 at 5:00 p.m. ET to discuss its first quarter financial results and current corporate developments. The dial-in number for the conference call is 866-250-2351 for domestic participants and 303-205-0066 for international participants.
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 callers and 303-590-3000 for international callers, using the passcode11088661#.
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 135,000 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 stages 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, SurgiFrost® and FrostByte™ products for surgical cryoablation of cardiac arrhythmias, RTI-Cardiovascular for allograft tissue services, and the development of PARSUS blood filtration technology. 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, 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.

 


 

ATS Medical, Inc.
Condensed Consolidated Statements of Operations
(in thousands except per share amounts)
                 
    Three Months Ended  
    March 31,  
    2007     2006  
Net sales
  $ 10,796     $ 9,730  
Cost of goods sold
    4,553       4,998  
 
           
Gross profit
    6,243       4,732  
 
               
Operating expenses:
               
Sales and marketing
    5,916       4,834  
Research and development
    1,657       405  
General and administrative
    2,649       1,942  
 
               
Amortization of intangibles
    415        
 
           
Total operating expenses
    10,637       7,181  
 
           
 
               
Operating loss
    (4,394 )     (2,449 )
 
           
 
               
Interest expense, net
    (445 )     (311 )
 
               
Change in value of derivative liability bifurcated from convertible senior notes
    19       1,185  
 
           
 
               
Net loss
    ($4,820 )     ($1,575 )
 
           
 
               
Net loss per share:
               
Basic and diluted
    ($0.11 )     ($0.05 )
 
               
Weighted average number of shares outstanding:
               
 
               
Basic and diluted
    42,052       31,187  

 


 

ATS Medical, Inc.
Condensed Consolidated Balance Sheets
(in thousands)
                 
    March 31,     December 31,  
    2007     2006  
Assets
               
Cash and short-term investments
  $ 21,010     $ 10,704  
Accounts receivable
    11,670       11,677  
Inventories
    19,682       18,782  
Prepaid expenses
    1,313       1,175  
 
           
Total current assets
    53,675       42,338  
 
               
Property and equipment, net
    7,937       8,213  
Intangible assets
    33,263       33,155  
Other assets
    1,980       2,134  
 
           
Total assets
  $ 96,855     $ 85,840  
 
           
 
               
Liabilities & shareholders’ equity
               
Accounts payable
  $ 2,330     $ 3,183  
Accrued compensation
    2,360       2,589  
Other accrued liabilities
    3,277       2,457  
Current maturities of bank notes payable
    994       1,133  
 
           
Total current liabilities
    8,961       9,362  
 
               
Convertible senior notes payable
    17,409       17,394  
Bank notes payable
    1,050       1,194  
 
               
Shareholders’ equity
    69,435       57,890  
 
           
Total liabilities & shareholders’ equity
  $ 96,855     $ 85,840  
 
           

 


 

ATS Medical, Inc.
Consolidated Condensed Statements of Cash Flow
(in thousands)
                 
    Three Months Ended March 31,  
    2007     2006  
Operating activities
               
Net loss
    ($4,820 )     ($1,575 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
    904       439  
Loss on disposal of equipment
          5  
Stock compensation expense
    316       199  
Non-cash interest expense
    112       115  
Change in value of convertible senior notes derivative liability
    (19 )     (1,185 )
Changes in operating assets and liabilities
    (1,203 )     (2,468 )
 
           
Net cash used in operating activities
    (4,710 )     (4,470 )
 
               
Investing activities
               
Maturities (purchases) of short-term investments, net
    2,567       (2,148 )
Payments for technology licenses
    (23 )      
Purchases of furniture, machinery and equipment
    (90 )     (97 )
 
           
Net cash provided by (used in) investing activities
    2,454       (2,245 )
 
               
Financing activities
               
Advances on notes payable
          1,500  
Repayments on notes payable
    (283 )     (209 )
Net proceeds from sales of common stock
    15,464       86  
 
           
Net cash provided by financing activities
    15,181       1,377  
 
               
Other items
    (52 )     (47 )
 
           
 
               
Increase (decrease) in cash and cash equivalents
  $ 12,873       ($5,385 )
 
           

 


 

ATS Medical, Inc.
Selected Revenue Information
(in thousands)
                 
    Revenue for the three months  
    ended March 31,  
    2007     2006  
Heart valve therapy
  $ 8,992     $ 8,628  
Surgical arrhythmia
    1,477       1,058  
Surgical tools & accessories
    327       44  
 
           
 
               
Total revenue
  $ 10,796     $ 9,730  
 
           
* * * *

 

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