-----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, MUrM21XaSi1eiAtt4EPIdlOMnXc89nIlYEj67Vs5vC9NuBYPI5W5/VW031oUIKcl DZ9sV3Fq83bshsXcRs3R3A== 0000950134-05-003396.txt : 20050218 0000950134-05-003396.hdr.sgml : 20050218 20050218151558 ACCESSION NUMBER: 0000950134-05-003396 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050218 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050218 DATE AS OF CHANGE: 20050218 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: 05627288 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 c92416e8vk.txt 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: FEBRUARY 18, 2005 (date of earliest event reported) ATS MEDICAL, INC. (Exact name of registrant as specified in its charter) Commission File Number: 0-18602 ------------------- MINNESOTA 41-1595629 (State or other jurisdiction of (IRS Employer Identification No.) incorporation) 3905 ANNAPOLIS LANE, 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): [ ] 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 17, 2005, ATS Medical, Inc. (the "Company") issued a press release to report final fourth quarter and full year results the year ended December 31, 2004. The full text of the press release is furnished as Exhibit 99.1 hereto and is incorporated by reference. The information 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 February 17, 2005, 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/ John R. Judd ------------------------------- John R. Judd Chief Financial Officer Date: February 18, 2005 EXHIBIT INDEX Exhibit No. Description - ---------- -------------------------------------------------------------- 99.1 Press Release, dated February 17, 2005, of ATS Medical, Inc. EX-99.1 2 c92416exv99w1.txt PRESS RELEASE EXHIBIT 99.1 Contact: Michael Dale, President/CEO Jack Judd, Chief Financial Officer 763/553-7736 EVC Group, Inc. Doug Sherk, Jennifer Beugelmans 415/896-6820 FOR IMMEDIATE RELEASE ATS MEDICAL REPORTS FINAL FOURTH QUARTER AND FULL YEAR 2004 RESULTS Full Year Revenue Grows 52% to $28 Million US Open Pivot(R) Open Heart Center Accounts Now Total 330 Total Open Pivot Valve Implants Surpass 100,000 Company Provides Guidance for 2005 MINNEAPOLIS, Feb. 17, 2005 -- ATS Medical, Inc. (Nasdaq: ATSI), developer, manufacturer and marketer of a variety of cardiac surgery product and services, including the ATS Open Pivot(R) mechanical heart valve, today reported that sales for the fourth quarter of 2004 increased 28% to $7.2 million, compared with sales of $5.6 million for the fourth quarter of 2003. The net loss for the fourth quarter of 2004 was $5.4 million compared with a net loss of $8.3 million in the fourth quarter of 2003. Included in the net loss amounts in the fourth quarters of 2004 and 2003 are $0.8 million and $4.4 million, respectively, relating to a lower of cost or market inventory adjustment. For the full year ended December 31, 2004 sales increased 52% to $28 million compared with sales of $18.5 million reported during for the full year ended December 31, 2003. Net loss for 2004 was $16.6 million which compared with a net loss of $13.3 million reported for 2003. The net loss for 2004 was adversely impacted by approximately $0.8 million in factory production ramp-up costs recognized as cost of goods sold. Net loss for 2003 was positively impacted by a $2.6 million gain on extinguishment of debt. Michael D. Dale, President and CEO of ATS Medical, commented, "We are pleased with the progress and success we have achieved toward reaching our long-term goals. At the beginning of 2004 we outlined a strategy to grow our U.S. market presence, continue to build mindshare for our superior mechanical valve and build our portfolio of products for the cardiac surgeon. During the fourth quarter we have successfully grown U.S. sales 39% compared with last year and nearly doubled our domestic market share to 10% while growing our international market share to 14%. In addition, we have also significantly grown our presence in U.S. open heart centers to 330, compared with 183 at the end of 2003. We believe that this success coupled with the fact that more than 100,000 Open Pivot heart valves have been implanted into patients underscores the superiority of our technology as well as our opportunity to grow our position as a leader in the mechanical heart valve market. "In addition, in 2004 we began to execute on our plan to leverage our cardiac surgery business platform," continued Mr. Dale. "Our agreement with CryoCath, which provides us access to their surgical cryotherapy products for the ablation of cardiac arrhythmias, will equip our sales force with an additional product to bring to the cardiac surgeon. This agreement officially started on January 1, 2005 and we would expect it to begin to contribute to revenue materially beginning in the second quarter. We also remain very excited about the potential of our PARSUS(TM) technology and expect it to develop into another important product in our portfolio. Looking ahead, we will continue to explore other strategic new business development opportunities, and anticipate reporting additional news on such efforts in the coming year. "Finally, we have also executed on our strategy to begin producing our own pyrolytic carbon components. We remain on target with our original estimates regarding cost per component and our capacity and are now past the ramp-up phase and into production. As we have outlined previously, our ability to lower our manufacturing costs through our own production will be a driving force behind our ability to achieve profitability in 2006," continued Mr. Dale. "Looking ahead to 2005, we expect total sales for the year to grow between 20% and 25% compared with 2004, to a range of $33 million to $35 million. We also continue to expect that we will consume our remaining high cost pyrolytic carbon inventory early in 2006 and reach our breakeven point in the first half of 2006," concluded Mr. Dale. CONFERENCE CALL TODAY ATS management will host a conference call and webcast today, February 17, 2005 at 4:30 p.m. ET to discuss its fourth quarter and full year 2004 financial results, outlook for 2005 and current corporate developments. The dial in number for the conference call is 800-366-3908 for domestic participants and 303-262-2194 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 through Midnight ET on Thursday, February 24, 2005 and can be accessed by dialing 800-405-2236 for domestic callers and 303-590-3000 for international callers, using the passcode 11023394#. A live webcast of the call can be accessed at http://www.atsmedical.com by clicking on the Investors icon. The webcast will also be archived on the company's website. ABOUT ATS MEDICAL ATS Medical manufactures and markets products and services focused on cardiac surgery. It is headquartered in Minneapolis and is global in scope with sales in more than 45 countries. The ATS Open Pivot heart valve has been implanted in over 100,000 patients and utilizes a unique pivot design resulting in improved performance and a lower risk profile. The ATS Medical web site is 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 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 to its Form 10-K for the year ended December 31, 2003. ### -----END PRIVACY-ENHANCED MESSAGE-----