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Cardiogenesis Corp · DEFM14A · On 2/12/99

Filed On 2/12/99   ·   SEC File 0-28424   ·   Accession Number 891618-99-560

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  As Of               Filer                 Filing     On/For/As Docs:Pgs              Issuer               Agent

 2/12/99  Cardiogenesis Corp                DEFM14A                1:213                                    891618

Definitive Proxy Solicitation Material -- Merger or Acquisition   ·   Schedule 14A
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: DEFM14A     Cardiogenesis Definitive Joint Proxy                 213  1,004K 


Document Table of Contents

Page (sequential) | (alphabetic) Top
 
11st Page
4Table of Contents
6Summary
7Ownership of Eclipse Immediately Following the Merger
9No Appraisal Rights
12Recent CardioGenesis Financial Results
"Recent Eclipse Financial Results
13Selected Historical and Selected Pro Forma Combined Financial Information
16Comparative Per Share Data
17Risk Factors
"Risks Related to the Merger
"Expenses related to the merger will have a negative effect on results of operations
18Risks Related to Business of Eclipse and CardioGenesis
31Comparative Market Price Data
32Where You Can Find More Information
"Incorporation of Certain Documents by Reference
33Forward-Looking Statements
34Eclipse Special Meeting
"Date, Time and Place of Eclipse Special Meeting
"Purpose
"Record Date and Outstanding Shares
"Vote Required and Voting Rights
"Proxies
35Solicitation of Proxies; Expenses
"Independent Accountants
"Recommendation of the Eclipse Board
36CardioGenesis Special Meeting
"Date, Time and Place of CardioGenesis Special Meeting
38Recommendation of the CardioGenesis Board
39Approval of the Merger and Related Transactions
"Joint Reasons For the Merger
40Eclipse's Additional Reasons For the Merger
41CardioGenesis' Additional Reasons For the Merger
43Material Contacts and Board Deliberations
46PaineWebber Opinion
53Bear Stearns Opinion
56CardioGenesis earnings per share
58Material Federal Income Tax Consequences
60Governmental and Regulatory Approvals
"Expected Accounting Treatment
61The Reorganization Agreement and Related Agreements
"Effective Time; Effect of Merger
"Conversion of Shares
62Treatment of Options and Stock Purchase Rights
"Stock Ownership Immediately Following the Merger
63Representations and Warranties
"Conduct of Eclipse's and CardioGenesis' Business Prior to the Merger
65No Solicitation
67Board and Management of the Combined Company Following the Merger
"Conditions to the Merger
68Termination of the Reorganization Agreement
69Termination Fees
"Voting Agreements
70Affiliate Agreements
"Interests of Certain Persons
71No Dissenters' or Appraisal Rights
72Comparison of Capital Stock
"Description of Eclipse Capital Stock
73Description of CardioGenesis Capital Stock
"Comparison of Rights of Stockholders of CardioGenesis and Shareholders of Eclipse
76Shareholder Proposals
84Eclipse and Cardiogenesis Unaudited Pro Forma Combined Condensed Financial Statements
89CardioGenesis Business
94Termination of Relationship with Boston Scientific
99Government Regulation
107Cardiogenesis Management's Discussion and Analysis of Financial Condition and Results of Operations
115Cardiogenesis Management and Executive Compensation
"Executive Officers and Directors
116Executive Compensation
"Summary Compensation Table
"Option Grants in Last Fiscal Year
117Aggregated Option Exercises in Last Fiscal Year and Fiscal Year-End Option Values
118Security Ownership of Certain Beneficial Owners and Management of Cardiogenesis
119Legal Matters
"Experts
120Other Matters
122Report of Independent Accountants
127Notes to Consolidated Financial Statements
"Cash and cash equivalents
141Notes to Condensed Consolidated Financial Statements
149Article I the Merger
"1.1 The Merger
"1.2 Effective Time; Closing
"1.3 Effect of the Merger
"1.4 Certificate of Incorporation; Bylaws
1501.5 Directors and Officers
"1.6 Effect on Capital Stock
1511.7 Surrender of Certificates
1521.8 No Further Ownership Rights in the Company Common Stock
1531.9 Lost, Stolen or Destroyed Certificates
"1.10 Tax and Accounting Consequences
"1.11 Taking of Necessary Action; Further Action
"Article Ii Representations and Warranties of the Company
"2.1 Organization of the Company
1542.2 Company Capital Structure
1552.3 Obligations With Respect to Capital Stock
"2.4 Authority
1562.5 Company SEC Filings; Company Financial Statements
1572.6 Absence of Certain Changes or Events
1602.8 Intellectual Property
"2.9 Compliance; Permits; Restrictions
1622.10 Litigation
"2.11 Brokers' and Finders' Fees
"2.12 Employee Benefit Plans and Employment Matters
1662.13 Absence of Liens and Encumbrances
"2.14 Environmental Matters
1672.15 Labor Matters
1682.16 Agreements, Contracts and Commitments
"2.17 Pooling of Interests
"2.18 Change of Control Payments
1692.19 Registration Statement; Proxy Statement/Prospectus
"2.20 Board Approval
"2.21 Fairness Opinion
"2.22 Section 203 of the Delaware General Corporation Law Not Applicable
170Article Iii Representations and Warranties of Parent and Merger Sub
"3.1 Organization of Parent
1713.2 Parent and Merger Sub Capital Structure
"3.3 Obligations With Respect to Capital Stock
1723.4 Authority
1733.5 Parent SEC Filings; Parent Financial Statements
1743.6 Absence of Certain Changes or Events
"3.7 Tax
1763.8 Intellectual Property
"3.9 Compliance; Permits; Restrictions
1783.10 Litigation
"3.11 Brokers' and Finders' Fees
"3.12 Employee Benefit Plans and Employment Matters
1813.13 Absence of Liens and Encumbrances
1823.14 Environmental Matters
"3.15 Labor Matters
1833.16 Agreements, Contracts and Commitments
"3.17 Pooling of Interests
1843.18 Change of Control Payments
"3.19 Registration Statement; Proxy Statement/Prospectus
"3.20 Board Approval
"3.21 Fairness Opinion
"Article Iv Conduct Prior to the Effective Time
"4.1 Conduct of Business
187Article V Additional Agreements
"5.1 Proxy Statement/Prospectus; Registration Statement; Other Filings; Board Recommendations
1885.2 Meetings of Stockholders and Shareholders
"5.3 Confidentiality
"5.4 No Solicitation
1925.5 Public Disclosure
"5.6 Legal Requirements
"5.7 Third Party Consents
"5.8 Firpta
"5.9 Notification of Certain Matters
1935.10 Best Efforts and Further Assurances
"5.11 Stock Options and Employee Benefits
1945.12 Form S-8
"5.13 Indemnification and Insurance
"5.14 Nasdaq Listing
"5.15 Parent Affiliate Agreement
"5.16 Company Affiliate Agreement
1955.17 Board of Directors and Certain Officers of the Combined Company
"Article Vi Conditions to the Merger
"6.1 Conditions to Obligations of Each Party to Effect the Merger
1966.2 Additional Conditions to Obligations of the Company
1976.3 Additional Conditions to the Obligations of Parent and Merger Sub
198Article Vii Termination, Amendment and Waiver
"7.1 Termination
1997.2 Notice of Termination; Effect of Termination
"7.3 Fees and Expenses
2017.4 Amendment
"7.5 Extension; Waiver
"Article Viii General Provisions
"8.1 Non-Survival of Representations, Warranties and Covenants
"8.2 Notices
2028.3 Interpretation
"8.4 Counterparts
"8.5 Entire Agreement; Third Party Beneficiaries
"8.6 Severability
2038.7 Other Remedies; Specific Performance
"8.8 Governing Law
"8.9 Rules of Construction
"8.10 Assignment
205Agreement
206October 21, 1998
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SCHEDULE 14A INFORMATION PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE SECURITIES EXCHANGE ACT OF 1934 Filed by the Registrant [X] Filed by a Party other than the Registrant [ ] Check the appropriate box: · Download Table [ ] Preliminary Proxy Statement [ ] Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2) [X] Definitive Proxy Statement [ ] Definitive Additional Materials [ ] Soliciting Material Pursuant to sec. 240.14(a)-11(c) or sec. 240.14a-12 CARDIOGENESIS CORPORATION -------------------------------------------------------------------------------- (Name of Registrant as Specified in Its Charter) ECLIPSE SURGICAL TECHNOLOGIES, INC. CARDIOGENESIS CORPORATION -------------------------------------------------------------------------------- (Name of Person(s) Filing Proxy Statement, if other than the Registrant) PAYMENT OF FILING FEE (Check the appropriate box): [ ] No fee required. [ ] Fee computed on table below per Exchange Act Rules 14a-6(i)(4) and 0-11. (1) Title of each class of securities to which transaction applies: ------------------------------------------------------------------------ (2) Aggregate number of securities to which transaction applies: ------------------------------------------------------------------------ (3) Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (Set forth the amount on which the filing fee is calculated and state how it was determined:* ------------------------------------------------------------------------ (4) Proposed maximum aggregate value of transaction: ------------------------------------------------------------------------ (5) Total fee paid: ------------------------------------------------------------------------ [X] Fee paid previously with preliminary materials. [ ] Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing. (1) Amount Previously Paid: ------------------------------------------------------------------------ (2) Form, Schedule or Registration Statement No.: ------------------------------------------------------------------------ (3) Filing Party: ------------------------------------------------------------------------ (4) Date Filed: ------------------------------------------------------------------------
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[CARDIOGENESIS LOGO] 540 OAKMEAD PARKWAY SUNNYVALE, CALIFORNIA 94086 ------------------------ NOTICE OF SPECIAL MEETING OF STOCKHOLDERS TO BE HELD ON MARCH 17, 1999 ------------------------ TO THE STOCKHOLDERS OF CARDIOGENESIS CORPORATION: NOTICE IS HEREBY GIVEN that a Special Meeting of Stockholders (the "CardioGenesis Special Meeting") of CardioGenesis Corporation, a Delaware corporation ("CardioGenesis"), will be held on Wednesday, March 17, 1999, at 9:00 a.m. local time, at the principal executive offices of CardioGenesis, 540 Oakmead Parkway, Sunnyvale, California 94086 to consider and vote upon the following: (1) A proposal to approve and adopt the Agreement and Plan of Reorganization (the "Reorganization Agreement"), dated as of October 21, 1998, among CardioGenesis, Eclipse Surgical Technologies, Inc., a California corporation ("Eclipse"), and RW Acquisition Corporation, a Delaware corporation and wholly-owned subsidiary of Eclipse ("Merger Sub"), and as contemplated thereby, the merger of Merger Sub with and into CardioGenesis (the "Merger") pursuant to which each share of Common Stock, $0.001 par value per share, of CardioGenesis will be converted into the right to receive 0.80 of a share of common stock, no par value per share, of Eclipse; and (2) To transact such other business as may properly come before the CardioGenesis Special Meeting or any adjournment thereof. Only stockholders of record at the close of business on February 8, 1999 are entitled to notice of, and to vote at, the CardioGenesis Special Meeting and any adjournments thereof. A list of CardioGenesis stockholders entitled to vote at the Special Meeting will be available for examination during ordinary business hours at CardioGenesis' principal executive offices for ten days prior to the CardioGenesis Special Meeting. Approval and adoption of the Reorganization Agreement and approval of the Merger will require the affirmative vote of the holders of at least a majority of the shares of CardioGenesis Common Stock outstanding on the record date. A form of proxy and the Joint Proxy Statement/Prospectus accompanying this Notice contain more detailed information with respect to the matters to be considered at the Special Meeting. You are cordially invited to attend the CardioGenesis Special Meeting in person, but if you are unable to do so, please complete, sign, date and promptly return the enclosed proxy in the enclosed envelope. If you attend the CardioGenesis Special Meeting and desire to revoke your proxy and vote in person, you may do so. A proxy may be revoked at any time before it is voted. THE CARDIOGENESIS BOARD RECOMMENDS THAT YOU VOTE "FOR" THE ABOVE PROPOSAL. By Order of the Board of Directors, /s/ RICHARD P. POWERS Richard P. Powers Secretary Sunnyvale, California February 10, 1999 WHETHER OR NOT YOU EXPECT TO ATTEND THE CARDIOGENESIS SPECIAL MEETING, PLEASE COMPLETE, SIGN AND DATE THE ENCLOSED PROXY AND MAIL IT PROMPTLY IN THE ENCLOSED ENVELOPE IN ORDER TO ASSURE REPRESENTATION OF YOUR SHARES. NO POSTAGE NEED BE AFFIXED IF THE PROXY IS MAILED IN THE UNITED STATES.
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JOINT PROXY STATEMENT/PROSPECTUS · Download Table PROXY STATEMENT/PROSPECTUS PROXY STATEMENT OF OF ECLIPSE SURGICAL CARDIOGENESIS TECHNOLOGIES, INC. CORPORATION The Eclipse Surgical Technologies, Inc. and CardioGenesis Corporation boards of directors have approved a reorganization agreement that would merge CardioGenesis with a subsidiary of Eclipse. Upon the completion of the merger, each CardioGenesis stockholder will receive 0.80 of a share of Eclipse common stock for each share of CardioGenesis common stock held by such stockholder. Eclipse common stock trades on the Nasdaq National Market under the symbol ESTI. CardioGenesis common stock trades on the Nasdaq National Market under the symbol CGCP. A total of approximately 9,908,040 shares of Eclipse common stock are expected to be issued in the merger. The Eclipse and CardioGenesis boards of directors have each called special meetings for their shareholders to vote on matters relating to the merger. You may vote at your special meeting if you own shares of Eclipse or CardioGenesis as of the close of business on February 8, 1999. The dates, times and places of these special meetings are as follows: · Download Table FOR ECLIPSE SHAREHOLDERS: FOR CARDIOGENESIS STOCKHOLDERS: Wednesday, March 17, 1999 Wednesday, March 17, 1999 9:00 a.m. local time 9:00 a.m. local time 1049 Kiel Court 540 Oakmead Parkway Sunnyvale, CA 94089 Sunnyvale, CA 94089 WE STRONGLY URGE YOU TO READ AND CONSIDER CAREFULLY THIS JOINT PROXY STATEMENT/PROSPECTUS, INCLUDING THE "RISK FACTORS" SECTION BEGINNING ON PAGE 12. THE "RISK FACTORS" SECTION DESCRIBES RISKS THAT YOU SHOULD CONSIDER IN DETERMINING WHETHER TO APPROVE THE PROPOSALS AT THE ECLIPSE AND CARDIOGENESIS SPECIAL MEETINGS. ------------------------ Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved these securities or passed upon the adequacy or accuracy of this joint proxy statement/prospectus. Any representation to the contrary is a criminal offense. ------------------------ This joint proxy statement/prospectus is dated February 10, 1999 and is expected to be first sent to Eclipse shareholders and CardioGenesis stockholders on February 12, 1999.
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TABLE OF CONTENTS · Download Table PAGE ---- SUMMARY............................. 1 The Companies..................... 1 Our Reasons for the Merger........ 1 What CardioGenesis Stockholders Will Receive in the Merger..... 2 Ownership of Eclipse Immediately Following the Merger........... 2 Eclipse Shareholders' Meeting..... 2 CardioGenesis Stockholders' Meeting........................ 3 Our Recommendation to Our Shareholders................... 3 Record Date; Voting Power......... 3 Vote Required..................... 3 Voting Procedures................. 3 Exchange of Stock Certificates.... 4 Share Ownership of Management and Certain Holders................ 4 Voting Agreements Signed by Certain Shareholders........... 4 No Appraisal Rights............... 4 Markets and Market Prices......... 4 Federal Income Tax Consequences... 5 Opinions of PaineWebber and Bear Stearns........................ 5 Interests of Certain Persons in the Merger..................... 5 Conditions to the Merger.......... 5 Termination of the Reorganization Agreement...................... 6 Expenses and Termination Fees..... 6 Expected Accounting Treatment..... 6 Regulatory Approvals.............. 6 Recent CardioGenesis Financial Results........................ 6 Recent Eclipse Financial Results........................ 7 Selected Historical and Selected Pro Forma Combined Financial Information.................... 8 Comparative Per Share Data........ 11 RISK FACTORS........................ 12 Risks Related to the Merger....... 12 · Download Table PAGE ---- Risks Related to Business of Eclipse and CardioGenesis...... 13 COMPARATIVE MARKET PRICE DATA....... 26 WHERE YOU CAN FIND MORE INFORMATION....................... 27 INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE...................... 27 FORWARD-LOOKING STATEMENTS.......... 28 ECLIPSE SPECIAL MEETING............. 29 Date, Time and Place of Eclipse Special Meeting................ 29 Purpose........................... 29 Record Date and Outstanding Shares......................... 29 Vote Required and Voting Rights... 29 Proxies........................... 29 Solicitation of Proxies; Expenses....................... 30 Independent Accountants........... 30 Recommendation of the Eclipse Board.......................... 30 CARDIOGENESIS SPECIAL MEETING....... 31 Date, Time and Place of CardioGenesis Special Meeting........................ 31 Purpose........................... 31 Record Date and Outstanding Shares......................... 31 Vote Required and Voting Rights... 31 Proxies........................... 31 Solicitation of Proxies; Expenses....................... 32 Independent Accountants........... 32 Recommendation of the CardioGenesis Board............ 33 APPROVAL OF THE MERGER AND RELATED TRANSACTIONS...................... 34 Joint Reasons For the Merger...... 34 Eclipse's Additional Reasons For the Merger..................... 35 CardioGenesis' Additional Reasons For the Merger................. 36 Material Contacts and Board Deliberations.................. 38 PaineWebber Opinion............... 41 i
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· Download Table PAGE ---- Bear Stearns Opinion.............. 48 Material Federal Income Tax Consequences................... 53 Governmental and Regulatory Approvals...................... 55 Expected Accounting Treatment..... 55 THE REORGANIZATION AGREEMENT AND RELATED AGREEMENTS................ 56 Effective Time; Effect of Merger......................... 56 Conversion of Shares.............. 56 Treatment of Options and Stock Purchase Rights................ 57 Stock Ownership Immediately Following the Merger........... 57 Representations and Warranties.... 58 Conduct of Eclipse's and CardioGenesis' Business Prior to the Merger.................. 58 No Solicitation................... 60 Board and Management of the Combined Company Following the Merger......................... 62 Conditions to the Merger.......... 62 Termination of the Reorganization Agreement...................... 63 Termination Fees.................. 64 Voting Agreements................. 64 Affiliate Agreements.............. 65 Interests of Certain Persons...... 65 No Dissenters' or Appraisal Rights......................... 66 COMPARISON OF CAPITAL STOCK......... 67 Description of Eclipse Capital Stock.......................... 67 Description of CardioGenesis Capital Stock.................. 68 Comparison of Rights of Stockholders of CardioGenesis and Shareholders of Eclipse.... 68 · Download Table PAGE ---- ECLIPSE AND CARDIOGENESIS UNAUDITED PRO FORMA COMBINED CONDENSED FINANCIAL STATEMENTS.............. 79 CARDIOGENESIS BUSINESS.............. 84 CARDIOGENESIS MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS........................ 102 CARDIOGENESIS MANAGEMENT AND EXECUTIVE COMPENSATION............ 110 Executive Officers and Directors...................... 110 Executive Compensation............ 111 Summary Compensation Table........ 111 Option Grants in Last Fiscal Year........................... 111 Aggregated Option Exercises in Last Fiscal Year and Fiscal Year-End Option Values......... 112 SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT OF CARDIOGENESIS.................. 113 LEGAL MATTERS....................... 114 EXPERTS............................. 114 SHAREHOLDER PROPOSALS............... 115 OTHER MATTERS....................... 115 CARDIOGENESIS INDEX TO FINANCIAL STATEMENTS........................ F-1 APPENDICES: Reorganization Agreement.......... A-1 PaineWebber Opinion............... B-1 Bear Stearns Opinion.............. C-1 ii
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SUMMARY This summary highlights selected information found in greater detail elsewhere in this joint proxy statement/prospectus. This summary does not contain all of the information that is important to you. We urge you to read the entire document (including the appendices) and the documents which Eclipse has incorporated by reference before you decide how to vote. The reorganization agreement is attached as Appendix A to this joint proxy statement/ prospectus. We encourage you to read the reorganization agreement. It is the legal document governing the merger. THE COMPANIES (PAGES 27 AND 84) ECLIPSE SURGICAL TECHNOLOGIES, INC. 1049 Kiel Court Sunnyvale, California 94089 (408) 747-0120 Eclipse is a medical device company which develops, manufactures, and markets cardiac revascularization products for the treatment of advanced cardiovascular disease and severe angina pain through transmyocardial revascularization (known as TMR) procedures and percutaneous transluminal myocardial revascularization (known as PTMR) procedures. TMR and PTMR procedures are investigational laser heart treatments in which channels are made in the heart muscle. The TMR procedure is performed by a heart surgeon through a small incision in the chest. The PTMR procedure is performed in a catheter-based procedure under local anesthesia by a cardiologist. CARDIOGENESIS CORPORATION 540 Oakmead Parkway Sunnyvale, California 94086 (408) 328-8500 CardioGenesis develops, manufactures and markets products involving TMR technology. CardioGenesis also manufactures and markets disposable products to perform intraoperative transmyocardial revascularization (known as ITMR), catheter-based percutaneous myocardial revascularization (known as PMR), and thorascopic transmyocardial revascularization (known as TTMR) to treat patients afflicted with debilitating angina. These probes and catheter systems deliver laser energy to create channels in the oxygen-deprived (ischemic) regions of the heart muscle (myocardium). OUR REASONS FOR THE MERGER (PAGE 34) The Board of Directors of Eclipse and the Board of Directors of CardioGenesis believe that the merger may result in a number of benefits, including: - Eclipse and CardioGenesis believe that the business combination of Eclipse and CardioGenesis will create a leading provider of TMR laser systems employing a fiber optic platform with a significant clinical/regulatory lead over competitors; - Eclipse and CardioGenesis believe that their respective product lines are complementary and that the combined company can offer products designed with the best features of each company's approach to TMR procedures; - Eclipse and CardioGenesis estimate that the combined company would have a much larger installed base of products, many of which will be installed at leading cardiological and cardiac surgery centers in the United States; - Eclipse and CardioGenesis believe that the combined company will have a substantial opportunity to consolidate their company's respective ongoing clinical trials and product development 1
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activities and reduce associated expenses; - Eclipse and CardioGenesis believe that the combined company will possess a significant proprietary patent position, supplementing Eclipse's issued patents with those of CardioGenesis; - Eclipse and CardioGenesis expect that the combined company will be able to achieve substantial benefits and considerable efficiencies from a single manufacturing plant that produces at higher manufacturing volumes resulting in improved operating margins; - Eclipse and CardioGenesis believe the transaction will create significant potential cost savings at the general and administrative expense and management levels as well as in sales and marketing; and - The Eclipse shareholders and CardioGenesis stockholders will have the ability to participate in the potential for growth of the combined company after the merger. The ability of the combined company to realize these benefits is subject to a number of risks as discussed on pages 12 through 25. We hope to complete the merger in the first quarter of 1999. WHAT CARDIOGENESIS STOCKHOLDERS WILL RECEIVE IN THE MERGER (PAGE 56) CardioGenesis stockholders will receive 0.80 of a share of Eclipse common stock for each share of CardioGenesis common stock they own prior to the merger. For example, if you own 1,000 shares of CardioGenesis common stock, you will receive 800 shares of Eclipse common stock in exchange for your shares. Similarly, each option or other right to purchase CardioGenesis common stock will convert into an option or other right to purchase 0.80 as many shares of Eclipse common stock at an adjusted exercise price. Eclipse will assume each employee stock option or purchase right of CardioGenesis under the terms of the applicable stock option or employee stock purchase plan. Eclipse will not issue fractional shares. Instead, CardioGenesis stockholders will receive cash for any fractional share of Eclipse common stock owed to them based on the closing price of Eclipse common stock on Nasdaq on the trading day immediately prior to the effective time of the merger. OWNERSHIP OF ECLIPSE IMMEDIATELY FOLLOWING THE MERGER Based upon the number of shares of CardioGenesis common stock issued and outstanding on the record date, Eclipse will issue an aggregate of approximately 9,908,040 shares of Eclipse common stock in the merger and the former holders of CardioGenesis common stock will hold approximately 36.0% of the total number of shares of Eclipse common stock issued and outstanding immediately after the merger. Based on the number of outstanding options and rights to purchase CardioGenesis common stock as of the record date, the total number of outstanding CardioGenesis options and purchase rights will become options and rights to purchase an aggregate of 1,887,085 shares of Eclipse common stock in the merger. ECLIPSE SHAREHOLDERS' MEETING (PAGE 29) The Eclipse special meeting will be held at Eclipse's offices located at 1049 Kiel Court, Sunnyvale, California 94089 on March 17, 1999 at 9:00 a.m. local time. At the meeting, Eclipse will ask its shareholders to approve the reorganization agreement including the issuance of Eclipse common stock in the merger. 2
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CARDIOGENESIS STOCKHOLDERS' MEETING (PAGE 31) The CardioGenesis special meeting will be held at CardioGenesis' offices located at 540 Oakmead Parkway, Sunnyvale, California 94086 on March 17, 1999 at 9:00 a.m. local time. At the meeting, CardioGenesis will ask its stockholders to approve and adopt the reorganization agreement and approve the merger. OUR RECOMMENDATION TO OUR SHAREHOLDERS (PAGES 30 AND 33) To the Eclipse shareholders: The Eclipse Board believes that the merger is fair to Eclipse and is in the best interests of both you and Eclipse. The Eclipse Board unanimously recommends that you vote "FOR" the proposal to approve the reorganization agreement including the issuance of Eclipse common stock in the merger. To the CardioGenesis stockholders: The CardioGenesis Board believes that the merger is fair to and is in the best interests of both you and CardioGenesis. The CardioGenesis Board unanimously recommends that you vote "FOR" the proposal to approve and adopt the reorganization agreement and to approve the merger. RECORD DATE; VOTING POWER (PAGES 29 AND 31) Each shareholder as of the close of business on February 8, 1999, which is the "record date," will be entitled to vote at the Eclipse special meeting or the CardioGenesis special meeting, as applicable. At the close of business on the record date, 17,621,323 shares of Eclipse common stock were outstanding and entitled to vote at the Eclipse special meeting. Each Eclipse shareholder will have one vote at the Eclipse special meeting for each share of Eclipse common stock owned as of the record date. At the close of business on the record date, 12,385,051 shares of CardioGenesis common stock were outstanding and entitled to vote at the CardioGenesis special meeting. Each CardioGenesis stockholder will have one vote at the CardioGenesis special meeting for each share of CardioGenesis common stock owned as of the record date. VOTE REQUIRED (PAGES 29 AND 31) The approval of the proposal to approve the reorganization agreement including the issuance of shares of Eclipse common stock in the merger requires the affirmative vote of at least a majority of the shares of Eclipse common stock outstanding and entitled to vote on the record date. The approval of the proposal to approve and adopt the reorganization agreement and to approve the merger requires the affirmative vote of at least a majority of the shares of CardioGenesis common stock outstanding and entitled to vote on the record date. VOTING PROCEDURES (PAGES 29 AND 31) There are two ways to vote at the Eclipse special meeting and the CardioGenesis special meeting: either by attending the special meeting or by mailing a proxy. However, whether or not a shareholder plans to attend the special meeting, such shareholder should return his or her proxy. Please fill out and sign the proxy card and mail it in the enclosed return envelope as soon as possible. Returning the proxy card ensures that the shares will be represented at the special meeting. If a shareholder wants to change his or her vote, the shareholder should send in a later-dated, signed proxy card to the company's secretary before the special meeting or attend the special meeting in person and vote. 3
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EXCHANGE OF STOCK CERTIFICATES (PAGE 57) If you are a CardioGenesis stockholder, you should NOT send in your stock certificates now. After the merger is completed, Eclipse will send CardioGenesis stockholders written instructions for exchanging their stock certificates. Eclipse shareholders will keep their current certificates, and will continue to hold the same number of shares of Eclipse common stock after the merger. SHARE OWNERSHIP OF MANAGEMENT AND CERTAIN HOLDERS (PAGE 113) As of the record date, the directors and executive officers of Eclipse, as a group, beneficially owned 4,914,633 shares of Eclipse common stock. As of the record date, the directors and executive officers of CardioGenesis, as a group, beneficially owned 4,271,693 shares of CardioGenesis common stock. VOTING AGREEMENTS SIGNED BY CERTAIN SHAREHOLDERS (PAGE 64) Douglas Murphy-Chutorian, M.D., Kenneth E. Bennert, Richard Mueller, Jr., Alan L. Kaganov, Robert L. Mortensen, Iain M. Watson, and Janet Kaiser-Castaneda, who together held or controlled approximately 28% of the Eclipse common stock outstanding as of the record date, have entered into voting agreements with CardioGenesis. These shareholders have agreed to vote in favor of the approval of the reorganization agreement including the issuance of Eclipse common stock in the merger and have granted CardioGenesis irrevocable proxies. Allen W. Hill, Edward F. Brennan, Richard P. Powers, David C. Hull, Jr., E. Walter Lange, Roseanne Varner, Jack M. Gill, and Robert C. Strauss, who together held or controlled approximately 29% of the CardioGenesis common stock outstanding as of the record date, have entered into voting agreements with Eclipse. These stockholders have agreed to vote in favor of the approval and adoption of the reorganization agreement and approval of the merger and have granted Eclipse irrevocable proxies. NO APPRAISAL RIGHTS Neither CardioGenesis stockholders nor Eclipse shareholders are entitled to appraisal or dissenters' rights in connection with the merger. MARKETS AND MARKET PRICES (PAGE 26) Eclipse common stock is quoted on Nasdaq under the symbol "ESTI." CardioGenesis common stock is quoted on Nasdaq under the symbol "CGCP." Following the completion of the merger, CardioGenesis common stock will cease to be quoted on Nasdaq. The following table sets forth the closing price per share of Eclipse common stock, and the closing price per share of CardioGenesis common stock, each as quoted on Nasdaq on October 21, 1998, the last trading day before Eclipse and CardioGenesis announced that they had signed the reorganization agreement. The table also includes the equivalent CardioGenesis per share price which equals the Eclipse closing per share price multiplied by the 0.80 exchange ratio in the merger. The equivalent CardioGenesis per share price can be compared to the CardioGenesis closing per share price to indicate the premium that may be realized by CardioGenesis stockholders as a result of the merger. · Download Table ECLIPSE CARDIOGENESIS COMMON COMMON EQUIVALENT STOCK STOCK CARDIOGENESIS CLOSING CLOSING PER SHARE PRICE PRICE PRICE ------- ------------- ------------- October 21, 1998..... $8.78 $2.2188 $7.025 The actual prices of Eclipse and CardioGenesis common stock prior to or at the time the merger is completed will vary 4
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and we cannot predict what they will be at that time or thereafter. FEDERAL INCOME TAX CONSEQUENCES (PAGE 53) We expect the merger to be treated as a tax-free reorganization for federal income tax purposes. CardioGenesis stockholders should not recognize gain or loss on the exchange of their stock, except for taxes on cash received in lieu of fractional shares. Eclipse shareholders will not recognize any gain or loss in connection with the merger. The reorganization agreement does not require the parties to obtain a ruling from the IRS as to the tax consequences of the merger. As a condition to the closing of the merger, CardioGenesis and Eclipse must both receive opinions from their own legal counsel that, based on certain assumptions and certifications, the merger will be treated as a tax-free reorganization for federal income tax purposes. TAX MATTERS ARE VERY COMPLICATED. THE TAX CONSEQUENCES OF THE MERGER TO YOU WILL DEPEND IN PART ON THE FACTS OF YOUR OWN SITUATION. WE URGE YOU TO CONSULT YOUR OWN TAX ADVISORS AS TO THE SPECIFIC TAX CONSEQUENCES OF THE MERGER, INCLUDING APPLICABLE FEDERAL, LOCAL AND FOREIGN TAX. OPINIONS OF PAINEWEBBER AND BEAR STEARNS (PAGES 41 AND 48) In deciding to approve the merger, each Board considered the opinion of the investment banking firm it retained. - Eclipse received an opinion from PaineWebber Incorporated, that the exchange ratio for the merger was fair, from a financial point of view, to Eclipse as of the date of the opinion. - CardioGenesis received an opinion from Bear, Stearns & Co. Inc., that the exchange ratio for the merger was fair, from a financial point of view, to the public stockholders of CardioGenesis as of the date of the opinion. These opinions are attached as Appendices B and C to this joint proxy statement/ prospectus. We encourage you to read these opinions carefully and in their entirety. INTERESTS OF CERTAIN PERSONS IN THE MERGER (PAGE 65) Certain members of CardioGenesis management and of the CardioGenesis Board have interests in the merger as employees and/or directors that are different from, or in addition to, your interests as a stockholder. If Eclipse and CardioGenesis complete the merger, Eclipse will continue certain indemnification arrangements for persons serving as directors and officers of CardioGenesis at the time of the merger for six years. Also, Eclipse will maintain a directors' and officers' liability insurance policy for the benefit of those persons for six years. In addition, the Eclipse Board has agreed to nominate and appoint Allen W. Hill, Jack M. Gill, and Robert C. Strauss to the Eclipse Board upon completion of the merger. The reorganization agreement also provides that, upon completion of the merger, Allen W. Hill will be the Chief Executive Officer of Eclipse and Richard P. Powers will be the Executive Vice President of Finance and Administration, Chief Financial Officer and Secretary of Eclipse. CONDITIONS TO THE MERGER (PAGE 62) The merger will not be completed unless the closing conditions in the reorganization agreement are met. Eclipse and CardioGenesis may each waive certain of the closing conditions of the other. 5
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TERMINATION OF THE REORGANIZATION AGREEMENT (PAGE 63) Either Eclipse or CardioGenesis may terminate the reorganization agreement if: - we mutually consent in writing; - we do not complete the merger by April 30, 1999; - a governmental entity takes any action which permanently prevents us from consummating the merger; - either of us fails to obtain the requisite shareholder approvals; - the CardioGenesis Board or the Eclipse Board recommends a superior proposal to its shareholders, or if either the CardioGenesis Board or the Eclipse Board withholds, withdraws, or modifies in an adverse manner to the other company its recommendation relating to the merger; or - CardioGenesis or Eclipse breaches any of its representations, warranties or covenants contained in the reorganization agreement. EXPENSES AND TERMINATION FEES (PAGE 64) We have agreed that we will each pay our own fees and expenses in connection with the merger, except that we will share equally all fees and expenses (other than attorneys' and accountants' fees and expenses) in connection with the printing and filing of this joint proxy statement/ prospectus and the registration statement of which this joint proxy statement/prospectus is a part. In addition, either CardioGenesis or Eclipse must pay the other company $3.0 million if the reorganization agreement is terminated under certain circumstances. EXPECTED ACCOUNTING TREATMENT (PAGE 55) We expect the merger will be accounted for as a pooling of interests in accordance with GAAP. REGULATORY APPROVALS (PAGE 55) This transaction was not subject to the filing and waiting period requirements of the Hart-Scott-Rodino Antitrust Improvement Act of 1976. Based on information available to us, we believe that the merger will be effected in compliance with federal, state and foreign antitrust laws. 6
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RECENT CARDIOGENESIS FINANCIAL RESULTS On February 9, 1999, CardioGenesis reported the following unaudited results of operations for the year and fourth quarter ended December 31, 1998. In the opinion of management, all adjustments consisting of normal recurring accruals and considered necessary for a fair presentation of the results of operations for the year have been included. · Download Table FISCAL FOURTH (IN THOUSANDS, EXCEPT PER YEAR QUARTER SHARE AMOUNTS) -------- ------- Sales.................. $ 3,078 98 Net loss............... (27,413) (7,905) Net loss per share..... (2.24) (0.64) RECENT ECLIPSE FINANCIAL RESULTS On February 8, 1999, Eclipse reported the following unaudited results of operations for the year and fourth quarter ended December 31, 1998. In the opinion of management, all adjustments consisting of normal recurring accruals and considered necessary for a fair presentation of the results of operations for the year have been included. · Download Table FISCAL FOURTH (IN THOUSANDS, EXCEPT YEAR QUARTER PER SHARE AMOUNTS) -------- -------- Sales................ $ 12,002 $ 5,346 Net loss............. (20,354) $ (3,472) Net loss per share... $ (1.18) $ (0.20) 7
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SELECTED HISTORICAL AND SELECTED PRO FORMA COMBINED FINANCIAL INFORMATION We are providing the following information to aid you in your analysis of the financial aspects of the merger. We derived this information from audited financial statements for 1993 through 1997 and unaudited financial statements for the nine months ended September 30, 1997 and 1998. This information is only a summary and you should read it in conjunction with each company's historical financial statements, related notes and accountants' reports, and Management's Discussion and Analysis of Financial Condition and Results of Operations contained in the annual reports, quarterly reports and other information on file with the SEC. For more financial information on Eclipse, see "Where You Can Find More Information" on page 27. For more financial information on CardioGenesis, see pages F-1 through F-22. ECLIPSE SELECTED HISTORICAL FINANCIAL INFORMATION (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS) · Enlarge/Download Table NINE MONTHS ENDED SEPTEMBER 30, YEAR ENDED DECEMBER 31, ------------------- ----------------------------------------------- 1998 1997 1997 1996 1995 1994 1993 -------- -------- -------- ------- ------- ------- ------ HISTORICAL CONSOLIDATED STATEMENT OF OPERATIONS DATA: Net revenues.................. $ 6,656 $ 3,863 $ 5,499 $ 9,759 $ 2,707 $ 2,020 $2,105 Loss from operations.......... (17,941) (14,715) (20,668) (5,712) (1,505) (1,547) (933) Net loss...................... (16,882) (13,015) (18,247) (4,156) (2,426) (1,982) (936) Net loss per share - basic and diluted..................... $ (0.99) $ (0.80) $ (1.11) $ (0.30) $ (0.23) $ (0.19) $(0.10) Shares used in computing net loss per share - basic and diluted..................... 17,126 16,303 16,404 14,078 10,470 10,231 9,381 · Enlarge/Download Table DECEMBER 31, SEPTEMBER 30, --------------------------------------------- 1998 1997 1996 1995 1994 1993 ------------- ------- ------- ------- ------ ------ HISTORICAL CONSOLIDATED BALANCE SHEET DATA: Cash and cash equivalents.............. $2,134 $16,997 $24,106 $ 123 $ 132 $ 131 Marketable securities.................. 14,786 18,197 27,957 -- -- -- Total assets........................... 28,792 43,474 58,706 2,459 2,922 1,953 Long term debt, less current portion... 5 10 20 -- 1,009 -- Total shareholders' equity (deficit)... 22,686 38,228 55,666 (1,429) (139) 1,011 8
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CARDIOGENESIS SELECTED HISTORICAL FINANCIAL INFORMATION (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS) · Enlarge/Download Table NINE MONTHS SEPTEMBER 23, ENDED 1993 (DATE OF SEPTEMBER 30, YEAR ENDED DECEMBER 31, INCEPTION) TO ------------------- ------------------------------------------- DECEMBER 31, 1998 1997 1997 1996 1995 1994 1993 -------- -------- -------- -------- ----------- ------- ------------- HISTORICAL CONSOLIDATED STATEMENT OF OPERATIONS DATA: Net sales............ $ 2,979 $ 5,509 $ 7,559 $ 3,959 $ -- $ -- $ -- Loss from operations......... (20,972) (14,597) (20,790) (11,086) (5,481) (1,982) (856) Net loss............. (19,509) (12,409) (17,971) (8,800) (5,299) (1,784) (853) Net loss per share-basic and diluted............ $ (1.60) $ (1.03) $ (1.49) $ (1.18) $(41,077.52) N/A N/A Shares used in computing net loss per share.......... 12,189 12,008 12,029 7,427 .129 0 0 · Enlarge/Download Table DECEMBER 31, SEPTEMBER 30, ---------------------------------------------- 1998 1997 1996 1995 1994 1993 ------------- ------- ------- ------- ------- ------ HISTORICAL CONSOLIDATED BALANCE SHEET DATA: Cash and cash equivalents............. $ 6,901 $ 6,047 $ 2,080 $ 4,150 $ 1,802 $1,113 Marketable securities................. 18,459 34,488 56,128 9,886 3,522 -- Total assets.......................... 32,041 48,240 64,297 16,223 5,885 1,127 Total stockholders' equity (deficit)........................... 25,336 44,146 61,395 (7,831) (2,636) (852) 9
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SELECTED UNAUDITED PRO FORMA COMBINED FINANCIAL INFORMATION (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS) We have presented below unaudited pro forma combined financial information that reflects the pooling of interests method of accounting, which means that for accounting and financial reporting purposes, we will treat our companies as if they had always been combined. We have included this information to give you a better picture of what the results of operations and financial position of the combined businesses of Eclipse and CardioGenesis might have been had the merger occurred on an earlier date. We have combined Eclipse's consolidated financial statements for the years ending 1995, 1996 and 1997 and for the nine months ended September 30, 1997 and 1998 with CardioGenesis' consolidated financial statements for the same periods in order to prepare the pro forma operating data. The unaudited pro forma combined balance sheet data gives effect to the merger as if it had occurred on September 30, 1998 and combines the unaudited consolidated balance sheet data of Eclipse and the unaudited consolidated balance sheet data of CardioGenesis as of September 30, 1998. The unaudited pro forma combined statement of operations data for the three years ended December 31, 1997 and the nine months ended September 30, 1997 and 1998 give effect to the merger as if it occurred at the beginning of the earliest period presented. We are providing this information for illustrative purposes only. It does not necessarily reflect what the results of operations or financial position of the combined company would have been if the merger had actually occurred at the beginning of the earliest period presented. This information also does not necessarily indicate what the combined company's future operating results or consolidated financial position will be. Eclipse and CardioGenesis estimate that in total they will incur transaction and integration costs of approximately $5.0 million associated with the merger, which will be charged to their operations when incurred, principally in the quarter in which the merger is completed. These transaction costs primarily include financial advisory and legal fees and costs associated with combining the operations of the two companies. An estimated charge of $5.0 million is reflected in the unaudited pro forma combined balance sheet data, but is not reflected in the unaudited pro forma combined statement of operations data. This charge is a preliminary estimate only, and is, therefore, subject to change. This information does not reflect the effect of any potential changes in revenues or any operating synergies which may result from combining the resources of our companies. · Enlarge/Download Table NINE MONTHS ENDED SEPTEMBER 30, YEAR ENDED DECEMBER 31, ------------------- ----------------------------- 1998 1997 1997 1996 1995 -------- -------- -------- -------- ------- PRO FORMA COMBINED STATEMENT OF OPERATIONS DATA: Net revenues................................. $ 9,635 $ 9,372 $ 13,058 $ 13,718 $ 2,707 Loss from operations......................... (38,913) (29,312) (41,458) (16,798) (6,986) Net loss..................................... (36,391) (25,424) (36,218) (12,956) (7,725) Net loss per share-basic and diluted......... (1.35) (0.98) (1.39) (0.65) (0.73) Shares used in computing net loss per share...................................... 26,877 25,909 26,027 20,020 10,573 · Download Table SEPTEMBER 30, 1998 ------------- PRO FORMA COMBINED BALANCE SHEET DATA: Cash and cash equivalents................................... $ 9,035 Marketable securities....................................... 33,245 Total assets................................................ 60,833 Long-term obligations....................................... 5 Total shareholders' equity.................................. 43,022 10
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COMPARATIVE PER SHARE DATA The following table sets forth certain historical per share data of Eclipse and CardioGenesis and combined per share data on an unaudited pro forma basis after giving effect to the merger on a pooling of interests basis of accounting. You should read the information set forth below in conjunction with the selected historical financial data and the unaudited pro forma combined condensed financial information, included elsewhere in this joint proxy statement/prospectus. The pro forma combined financial data are not necessarily indicative of the operating results that would have been achieved had the merger been consummated as of the beginning of the periods presented and should not be construed as representative of future operations. Historical book value per share is computed by dividing total shareholders' equity by the number of shares outstanding at the end of each period. For purposes of the pro forma combined data, Eclipse's financial data for the three fiscal years ended December 31, 1997 and for the nine month periods ended September 30, 1997 and 1998 have been combined with CardioGenesis financial data for the same periods. Pro forma combined book value per share is computed by dividing pro forma shareholders' equity by the number of shares of Eclipse common stock expected to be outstanding immediately after the merger. The equivalent pro forma combined net loss per CardioGenesis share and equivalent pro forma combined book value per CardioGenesis share are calculated by multiplying the respective pro forma amounts by the exchange ratio. · Enlarge/Download Table NINE MONTHS ENDED SEPTEMBER 30, YEAR ENDED DECEMBER 31, ------------------ --------------------------------- 1998 1997 1997 1996 1995 -------- ------ -------- ------ ----------- HISTORICAL -- ECLIPSE: Net loss per share................................ $(0.99) $(0.80) $(1.11) $(0.30) $(0.23) · Download Table SEP. 30, DEC. 31, 1998 1997 -------- -------- Book value per share.............................. $ 1.30 $ 2.27 · Enlarge/Download Table NINE MONTHS ENDED SEPTEMBER 30, YEAR ENDED DECEMBER 31, ------------------ --------------------------------- 1998 1997 1997 1996 1995 -------- ------ -------- ------ ----------- HISTORICAL -- CARDIOGENESIS: Net loss per share................................ $(1.60) $(1.03) $(1.49) $(1.18) $(41,077.52) · Download Table SEP. 30, DEC. 31, 1998 1997 -------- -------- Book value per share.............................. $ 2.07 $ 3.66 · Enlarge/Download Table NINE MONTHS ENDED SEPTEMBER 30, YEAR ENDED DECEMBER 31, ------------------ --------------------------------- 1998 1997 1997 1996 1995 -------- ------ -------- ------ ----------- PRO FORMA AND EQUIVALENT PRO FORMA COMBINED NET LOSS PER SHARE: Pro forma net loss per Eclipse share............ $(1.35) $(0.98) $(1.39) $(0.65) $(0.73) Equivalent pro forma net loss per CardioGenesis share......................................... $(1.08) $(0.79) $(1.11) $(0.52) $(0.58) · Download Table SEP. 30, DEC. 31, 1998 1997 -------- -------- PRO FORMA COMBINED BOOK VALUE PER SHARE (AT PERIOD END): Pro forma combined book value per Eclipse share......................................... $ 1.58 $ 2.92 Equivalent pro forma combined book value per CardioGenesis share........................... $ 1.26 $ 2.33 11
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RISK FACTORS You should carefully consider the following factors in evaluating whether to: - approve and adopt the reorganization agreement and to approve the merger; or - approve the issuance of Eclipse common stock in the merger. These factors do not contain all of the information that may be important to you. You should read the entire joint proxy statement prospectus, including the forward looking statements, before deciding how to vote. RISKS RELATED TO THE MERGER ECLIPSE AND CARDIOGENESIS MAY NOT RECOGNIZE THE ANTICIPATED BENEFITS OF THE MERGER IF THEY ARE NOT ABLE TO INTEGRATE THEIR OPERATIONS EFFECTIVELY. The combined company will not achieve the anticipated benefits of the merger unless Eclipse and CardioGenesis successfully combine their operations in a timely manner. If this does not happen, the combined company may suffer: - increased operating costs; - lower than anticipated financial results; or - the loss of customers or employees. The failure to successfully integrate Eclipse and CardioGenesis would have a material adverse effect on the business, financial condition and results of operations of the combined company. Integrating Eclipse and CardioGenesis will be a complex, time-consuming and expensive process. Prior to the merger, Eclipse and CardioGenesis operated independently, and following the merger, the combined company must operate as a combined organization using common: - information communication systems; - operating procedures; - financial controls; - research and development and sales and marketing efforts; - distribution and other sales channels; - product lines; - business cultures; and - human resource practices. Senior officers of the combined company will be required to devote substantial attention to designing and implementing a plan to combine the companies. This could distract them from managing the business of the combined company. The integration of Eclipse and CardioGenesis may involve additional substantial difficulties, costs and delays, including: - perceived adverse changes in customer service standards, business focus or product offerings available to customers; and - inefficiencies in delivering products to the customers. A DECREASE IN THE TRADING PRICE OF ECLIPSE COMMON STOCK WILL REDUCE THE VALUE THAT CARDIOGENESIS STOCKHOLDERS WILL RECEIVE IN THE MERGER. Because the exchange ratio for the merger is fixed, a decrease in the market price of Eclipse common stock will reduce the dollar value of the stock received in the merger by CardioGenesis stockholders. You are urged to obtain current quotations for Eclipse and CardioGenesis common stock before voting your shares at your special meeting of shareholders. Eclipse common stock and CardioGenesis common stock historically have had substantial price volatility. The recent market prices of Eclipse common stock and CardioGenesis common stock are set forth on page 26 under "Comparative Market Price Data." EXPENSES RELATED TO THE MERGER WILL HAVE A NEGATIVE EFFECT ON RESULTS OF OPERATIONS. We estimate that the negotiation and implementation of the merger will result in aggregate pretax expenses to Eclipse and CardioGenesis of approximately $5.0 million, primarily relating to costs associated with combining the operations of the two companies and the fees of financial 12
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advisors, attorneys and accountants. We cannot assure you that our estimate is correct or that unanticipated contingencies will not occur. These events could substantially increase the costs of combining the operations of the two companies. The costs associated with the merger will negatively impact results of operations in the quarter ending March 31, 1999. THE COMBINED COMPANY MAY NOT BE ABLE TO RETAIN AND INTEGRATE KEY PERSONNEL AND THE FAILURE TO DO SO COULD ADVERSELY AFFECT THE BUSINESS OF THE COMBINED COMPANY. The success of the combined company depends upon the continued service of key personnel. The loss of services of any of the key members of the combined company's management team or its failure to attract other qualified personnel could materially adversely affect the combined company's business. None of the key personnel of the combined company will be subject to an employment agreement. The competition to attract, retain and motivate qualified technical, sales and operations personnel is intense. We cannot assure you that the combined company can retain its key personnel or attract other qualified personnel in the future. THE CARDIOGENESIS DISTRIBUTION AGREEMENT WITH BOSTON SCIENTIFIC CORPORATION MAY INTERFERE WITH THE ABILITY OF THE COMBINED COMPANY TO DISTRIBUTE OUTSIDE OF THE U.S. PRODUCTS THAT INCORPORATE CARDIOGENESIS TECHNOLOGY. In January 1997, CardioGenesis and Boston Scientific Corporation entered into an International Distribution Agreement under which Boston Scientific served as the exclusive distributor for CardioGenesis products outside of the U.S. If the Boston Scientific agreement were to continue in effect after the merger, CardioGenesis could not, without Boston Scientific's approval, license Eclipse to incorporate CardioGenesis technology into any Eclipse products to be sold outside of the U.S. Furthermore, Boston Scientific would have the exclusive right, if it so elected under the agreement, to market outside of the U.S. any products manufactured by Eclipse that incorporated CardioGenesis technology. Accordingly, in such event Eclipse could be required to terminate one or more of its existing international distribution agreements. Such terminations could result in difficulties in integrating product lines, and in delays in distribution, which could have a material adverse effect on the combined company. In early January 1999, CardioGenesis sent notice to Boston Scientific terminating the agreement for various breaches by Boston Scientific of its obligations under the agreement. Boston Scientific has contested such termination and has contended that this termination by CardioGenesis was an attempt to circumvent a provision of the agreement that requires payment to Boston Scientific of a $10.0 million termination fee in the event the agreement is terminated by a successor corporation. CardioGenesis has vigorously denied Boston Scientific's contentions. While CardioGenesis and Boston Scientific currently are in settlement discussions with respect to the agreement, if CardioGenesis does not prevail in its position, or is not able to negotiate a satisfactory resolution of this matter with Boston Scientific, the combined company may be required to expend significant time, energy and funds to resolve this matter, which could have a material adverse effect on the business, financial condition and results of operations on the combined company. See "CardioGenesis Business -- Termination of Relationship with Boston Scientific" at page 89. RISKS RELATED TO BUSINESS OF ECLIPSE AND CARDIOGENESIS ECLIPSE OR CARDIOGENESIS MAY FAIL TO OBTAIN REQUIRED REGULATORY APPROVALS TO MARKET THEIR PRODUCTS IN THE UNITED STATES. Eclipse or CardioGenesis may not be able to obtain the regulatory approval required for commercial sale of their TMR and PTMR laser systems in a timely manner. To date, none of the products of Eclipse or CardioGenesis have been approved for sale in the United States. 13
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The business, financial condition and results of operations of Eclipse or CardioGenesis could be materially and adversely affected by any of the following events, circumstances or occurrences related to the regulatory process: - delays in initiating or completing clinical trials or in the receipt of regulatory approvals; - the failure to obtain regulatory approvals for such products; - significant limitations in the indicated uses for which such products may be marketed, or - substantial costs incurred in obtaining such approvals. Eclipse and CardioGenesis must submit and the FDA must approve applications for preliminary market approval, known as PMA, before they can sell their TMR and PTMR laser systems as medical devices. Before submitting a PMA application, they must complete clinical testing to demonstrate the safety and effectiveness of their products. In 1997, Eclipse submitted a PMA application to the FDA for certain applications of its TMR laser system. On October 27, 1998, an advisory panel of the FDA recommended that the FDA approve Eclipse's PMA application for the TMR laser system. Along with its approval, the FDA panel requested that Eclipse conduct postmarket surveillance in a form to be determined through further discussions with the FDA. Eclipse also has applied for and received IDEs to engage in various clinical trials of its PTMR products and procedures. Eclipse must successfully complete clinical trials of its PTMR products and procedures before filing a PMA application for those products and procedures. CardioGenesis has received FDA approval of: - three IDEs for its ITMR laser system and all three of these trials have begun; and - one IDE for its Axcis PMR laser system for a multi-center clinical trial of no-option patients at up to 12 clinical sites. CardioGenesis has not submitted an application to the FDA for an IDE for its TTMR laser system. ECLIPSE OR CARDIOGENESIS PRODUCTS MAY CONTAIN DEFECTS WHICH COULD DELAY REGULATORY APPROVAL OR MARKET ACCEPTANCE OF THEIR PRODUCTS. In January 1996, CardioGenesis reported to the FDA the existence of an error in the software incorporated into the Ho:YAG laser included in its TMR laser systems. CardioGenesis' laser manufacturer, New Star Lasers, determined that, under certain circumstances, the laser could be fired even though its control panel indicated it was in the "stand-by" mode. CardioGenesis initiated a voluntary field correction of the lasers, categorized as a Class II recall by the FDA, and the software error has been corrected. FDA defines a Class II recall as one in which use of, or exposure to, the product may cause temporary or permanent adverse health consequences. The FDA has acknowledged the correction of the software error and the completion of the related field activities. Eclipse or CardioGenesis may experience future product defects, malfunctions, manufacturing difficulties or recalls related to the lasers or other components used in their TMR systems. Any such occurrence could cause a delay in regulatory approvals or adversely affect the acceptance of their products and could have a material adverse effect on the business, financial condition and results of operations of Eclipse or CardioGenesis. ECLIPSE OR CARDIOGENESIS MAY FAIL TO COMPLY WITH INTERNATIONAL REGULATORY REQUIREMENTS AND COULD BE SUBJECT TO REGULATORY DELAYS, FINES OR OTHER PENALTIES. Regulatory requirements in foreign countries for international sales of medical devices often vary from country to country. The impact of the following factors would have a material adverse effect on the business, financial condition and results of operations of Eclipse or CardioGenesis: - delays in receipt of, or failure to receive, foreign regulatory approvals or clearances; 14
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- the loss of previously obtained approvals or clearances; or - the failure to comply with existing or future regulatory requirements. The products of Eclipse and CardioGenesis will be subject to other regulatory requirements in the European Union and other countries. Any enforcement action by regulatory authorities with respect to past or future regulatory noncompliance could have a material adverse effect on the business, financial condition and results of operations of Eclipse or CardioGenesis. The time required to obtain approval for sale in foreign countries may be longer or shorter than required for FDA approval, and the requirements may differ. In addition, there may be foreign regulatory barriers other than regulatory approval. Except as stated in the following sentence, the FDA must approve exports of devices that require a PMA but are not yet approved domestically. An unapproved device may be exported without prior FDA approval to any member country of the European Union and the other "listed" countries, including Australia, Canada, Israel, Japan, New Zealand, Switzerland and South Africa: - if the device is approved for sale by that country; or - for investigational use in accordance with the laws of that country. Eclipse received the CE Mark for its TMR laser system in December 1996 and for its PTMR laser system in July 1998. To sell its TMR laser systems within the European Economic Area, CardioGenesis has received approval to affix CE markings on TMR laser systems to attest CardioGenesis' compliance with the requirements of the Medical Device Directive of the European Economic Area. In the European Economic Area, Eclipse and CardioGenesis will be: - subject to continued supervision; - required to report any serious adverse incidents to the appropriate authorities; and - required to comply with additional national requirements that are outside the scope of the Medical Device Directive. CardioGenesis has not received CE Mark certification for the sale of its TTMR laser system in the European Economic Area. Eclipse became ISO 9001 certified in May 1997. CardioGenesis has received ISO 9001/ EN 46001 certification, which was required to meet the CE Mark certification prerequisites. Eclipse or CardioGenesis may not be able to: - achieve or maintain the compliance required for CE marking on all or any of their products; and - produce their products profitably and in a timely manner while complying with the requirements of the Medical Device Directive and other regulatory requirements. If Eclipse or CardioGenesis fails to comply with applicable regulatory requirements it could face: - fines, injunctions, civil penalties; - recalls or seizures of products; - total or partial suspensions of production; - refusals by foreign governments to permit product sales; and - criminal prosecution. Furthermore, if existing regulations are changed or new regulations or policies are adopted, Eclipse or CardioGenesis may: - not be able to obtain, or affect the timing of, future regulatory approvals or clearances; - not be able to obtain necessary regulatory clearances or approvals on a timely basis or at all; and - be required to incur significant costs in obtaining or maintaining such foreign regulatory approvals. ECLIPSE AND CARDIOGENESIS PRODUCTS ARE EXPERIMENTAL AND HAVE NOT BEEN BROADLY ADOPTED BY THE MEDICAL COMMUNITY AND UNLESS THEY ARE BROADLY ADOPTED THEIR BUSINESSES WILL BE 15
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ADVERSELY AFFECTED. TMR and PTMR products using lasers are experimental and have not yet achieved broad clinical adoption. Eclipse and CardioGenesis cannot predict whether or at what rate and how broadly their products will be adopted by the medical community. The business, financial condition and results of operations of Eclipse or CardioGenesis may be adversely and materially affected if: - their respective products fail to achieve significant clinical adoption; or - their TMR or PTMR laser systems fail to achieve significant market acceptance. Positive endorsements by physicians are essential for clinical adoption of TMR and PTMR laser systems. Even if the clinical efficacy of TMR and PTMR laser systems is established, physicians may elect not to recommend TMR or PTMR laser systems for any number of reasons. The reasons why TMR or PTMR laser systems may effectively treat coronary artery disease are not well understood. Although Eclipse and CardioGenesis intend to use research, development and clinical efforts to understand better the physiological effects of TMR and PTMR treatment, Eclipse and CardioGenesis may not achieve such understanding on a timely basis, or at all. TMR and PTMR laser systems may not be clinically adopted unless Eclipse or CardioGenesis: - understand thoroughly the physiological effects of the products, or - disseminate such understanding within the medical community. Clinical adoption of these products will also depend upon: - the ability of Eclipse or CardioGenesis to facilitate training of cardiothoracic surgeons and interventional cardiologists in TMR and PTMR therapy; and - the willingness of such physicians to adopt and recommend such procedures to their patients. Patient acceptance of the procedure will depend on: - physician recommendations; - the degree of invasiveness; - the effectiveness of the procedure; and - the rate and severity of complications associated with the procedure as compared to other procedures. ECLIPSE AND CARDIOGENESIS PRODUCTS DEPEND ON TMR TECHNOLOGY WHICH IS RAPIDLY CHANGING, WHICH COULD REQUIRE THEM TO INCUR SUBSTANTIAL PRODUCT DEVELOPMENT EXPENDITURES TO RESPOND TO INDUSTRY CHANGES. TMR and PTMR laser systems are the only products of Eclipse and CardioGenesis. Accordingly, if Eclipse or CardioGenesis fails to develop and commercialize successfully their TMR and PTMR laser systems, then their business, financial condition and results of operations would be materially adversely affected. The medical device industry is characterized by rapid and significant technological change. The future success of Eclipse and CardioGenesis will depend in large part on their ability to respond to such changes. In addition, Eclipse and CardioGenesis must expand the indications and applications for their products by developing and introducing enhanced and new versions of their TMR and PTMR laser systems. Product research and development requires substantial expenditures and is inherently risky. Eclipse and CardioGenesis may not be able to: - identify products for which demand exists; or - develop products that have the characteristics necessary to treat particular indications. Even if Eclipse or CardioGenesis identifies and develops such products, they may not receive regulatory approval and may not be commercially successful. THIRD PARTIES MAY LIMIT THE DEVELOPMENT AND PROTECTION OF ECLIPSE AND CARDIOGENESIS INTELLECTUAL PROPERTY WHICH COULD ADVERSELY AFFECT THEIR COMPETITIVE POSITIONS. The success of 16
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Eclipse and CardioGenesis is dependent in large part on their ability to: - obtain patent protection for their products and processes; - preserve their trade secrets and proprietary technology; and - operate without infringing upon the patents or proprietary rights of third parties. The medical device industry has been characterized by extensive litigation regarding patents and other intellectual property rights. Companies in the medical device industry have employed intellectual property litigation to gain a competitive advantage. Certain competitors and potential competitors of Eclipse and CardioGenesis have obtained United States patents covering technology that could be used for certain TMR and PTMR procedures. There can be no assurance such competitors, potential competitors or others have not filed and do not hold international patents covering other TMR or PTMR technology. In addition, international patents may not be interpreted the same as any counterpart United States patents. In September 1995, one of Eclipse's competitors sent Eclipse a notice of potential infringement of their patent regarding a method for TMR utilizing synchronization of laser pulses to the electrical signals from the heart. After discussion with patent counsel, Eclipse concluded that it did not utilize the process and/or apparatus that was the subject of the patent at issue, and Eclipse provided a response to the competitor to that effect. Eclipse has not received any additional correspondence from this competitor on these matters. While Eclipse and CardioGenesis periodically review the scope of their patents and other relevant patents of which they are aware, the question of patent infringement involves complex legal and factual issues. Any conclusion regarding infringement may not be consistent with the resolution of any such issues by a court. Eclipse and CardioGenesis may not be able to protect their intellectual property because: - patents may not be issued; - patents may be challenged, invalidated or designed around by competitors; or - patent protection may not continue to be available for surgical methods in the future. COSTLY LITIGATION MAY BE NECESSARY TO PROTECT OUR INTELLECTUAL PROPERTY RIGHTS. Eclipse and CardioGenesis may have to engage in time consuming and costly litigation to protect their intellectual property rights or to determine the proprietary rights of others. In addition, Eclipse or CardioGenesis may become subject to: - patent infringement claims or litigation; or - interference proceedings declared by the U.S. Patent Office to determine the priority of inventions. Defending and prosecuting intellectual property suits, U.S. Patent Office interference proceedings and related legal and administrative proceedings are both costly and time-consuming. Eclipse or CardioGenesis may be required to litigate further to: - enforce their issued patents; - protect their trade secrets or know-how; or - determine the enforceability, scope and validity of the proprietary rights of others. Any litigation or interference proceedings will result in: - substantial expense; and - significant diversion of effort by technical and management personnel. If the results of such litigation or interference proceedings are adverse to Eclipse or CardioGenesis, then the results may: - subject such company to significant liabilities to third parties; 17
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- require such company to seek licenses from third parties; - prevent such company from selling its products in certain markets or at all; or - require such company to modify its products. Although patent and intellectual property disputes regarding medical devices are often settled through licensing and similar arrangements, costs associated with such arrangements may be substantial and could include ongoing royalties. Furthermore, there can be no assurance the necessary licenses would be available on satisfactory terms, if at all. Adverse determinations in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent Eclipse or CardioGenesis from manufacturing and selling their products. This would have a material adverse effect on the business, financial condition and results of operations of such company. ECLIPSE AND CARDIOGENESIS RELY ON PATENT AND TRADE SECRET LAWS WHICH ARE COMPLEX AND MAY BE DIFFICULT TO ENFORCE. The validity and breadth of claims in medical technology patents involve complex legal and factual questions and, therefore, may be highly uncertain. Issued patent or patents based on pending patent applications or any future patent application may not exclude competitors or may not provide a competitive advantage to Eclipse or CardioGenesis. In addition, patents issued or licensed to Eclipse or CardioGenesis may not be held valid if subsequently challenged and others may claim rights in or ownership of such patents. Furthermore, there can be no assurance that competitors: - have not developed or will not develop similar products; - will not duplicate products of Eclipse or CardioGenesis; or - will not design around any patents issued to or licensed by Eclipse or CardioGenesis. Since patent applications in the United States are maintained in secrecy until patents issue, Eclipse and CardioGenesis cannot be certain: - others did not first file applications for inventions covered by their pending patent applications, nor - that they will not infringe any patents that may issue to others on such applications. The U.S. patent laws were recently amended to exempt physicians, other health care professionals, and affiliated entities from infringement liability for medical and surgical procedures performed on patients. Eclipse and CardioGenesis are not able to predict if this amendment will materially affect their ability to protect their proprietary methods and procedures. Competitors may: - independently develop proprietary information substantially equivalent to the proprietary information and techniques of Eclipse or CardioGenesis, or - otherwise gain access to their proprietary technology. In addition to their patents, Eclipse and CardioGenesis rely upon trade secrets, technical know-how and continuing technological innovation to develop and maintain their competitive position. Eclipse and CardioGenesis may not be able meaningfully to protect their unpatented technology because: - their employees, consultants and advisors may breach their confidentiality and invention assignment agreements and there may not be an adequate remedy for such breach; - their competitors may independently develop substantially equivalent proprietary information and techniques; or - competitors may somehow otherwise gain access to their proprietary technology. The inability of Eclipse or CardioGenesis to protect their unpatented intellectual property could materially adversely affect their business. 18
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ECLIPSE AND CARDIOGENESIS FACE INTENSE COMPETITION AND COMPETITIVE PRODUCTS COULD RENDER THEIR PRODUCTS OBSOLETE. The market for TMR and PTMR laser systems is intensely competitive and is constantly becoming more competitive. If competitors are more effective in developing new products and procedures and marketing existing and future products, the business, financial condition and results of operations of Eclipse or CardioGenesis may be materially adversely affected. The market for TMR and PTMR laser systems is characterized by rapid technical innovation. Accordingly, competitors may succeed in developing TMR and PTMR products or procedures that: - are more effective than products marketed by Eclipse or CardioGenesis; - are more effectively marketed than products marketed by Eclipse or CardioGenesis; or - may render the products or technology of Eclipse or CardioGenesis obsolete. Eclipse and CardioGenesis compete with: - PLC Systems, Inc.; - U.S. Surgical Corporation; and - Johnson & Johnson. Each of these competitors are currently selling TMR and/or PTMR products for investigational use in the U.S. and abroad. Certain companies, including PLC, have: - completed enrollment in randomized clinical trials of products and procedures involving TMR, and - received regulatory approvals in Europe to begin commercially marketing their various TMR products. Earlier entrants in the market in a therapeutic area often obtain and maintain greater market share than later entrants. Even in the event that Eclipse or CardioGenesis obtains regulatory approval for one of their products, they will face competition for market acceptance and market share for that product. Their ability to compete may depend in significant part on the timing of introduction of competitive products into the market, which will be affected by the pace, relative to competitors, at which they are able to: - develops products; - complete clinical testing and regulatory approval processes; - obtain third party reimbursement acceptance; and - supply adequate quantities of the product to the market. ECLIPSE AND CARDIOGENESIS SELL THEIR PRODUCTS INTERNATIONALLY WHICH SUBJECTS THEM TO CERTAIN SIGNIFICANT RISKS OF TRANSACTING BUSINESS IN FOREIGN COUNTRIES. International sales account for a significant portion of the revenue of CardioGenesis. Even if the FDA approves the sale of CardioGenesis products in the United States, CardioGenesis expects international sales will continue to account for a significant portion of its revenues. Eclipse also sells its products internationally. The international revenue of Eclipse and CardioGenesis is subject to the following risks: - foreign currency fluctuations; - economic or political instability; - foreign tax laws; - shipping delays; - various tariffs and trade regulations; - restrictions and foreign medical regulations; - customs duties, export quotas or other trade restrictions; and - difficulty in protecting intellectual property rights. Any of these factors could have a material adverse effect on the business, financial condition and results of operations of Eclipse or CardioGenesis. 19
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ECLIPSE AND CARDIOGENESIS PRODUCTS ALSO COMPETE WITH ALTERNATIVE TREATMENT METHODS AND THEIR PRODUCTS MUST REPLACE THESE METHODS TO BE COMMERCIALLY SUCCESSFUL. Many of the medical indications that may be treatable with TMR and PTMR laser systems are currently being treated by drug therapies or surgery and other interventional therapies, including percutaneous transluminal coronary angioplasty (known as PTCA) and coronary artery bypass graft. The business, financial condition and results of operations of Eclipse and CardioGenesis would be materially adversely affected if TMR technology fails: - to replace or augment existing therapies; or - to be more effective, safer or more cost effective than new therapies. A number of the existing therapies: - are widely accepted in the medical community; - have a long history of use; and - continue to be enhanced rapidly. Procedures using TMR and PTMR technology may not be able to replace or augment such established treatments. Clinical research results may not support the use of TMR or PTMR procedures to augment or replace existing treatments. Others are developing new surgical procedures and new drug therapies to treat coronary artery disease. These new procedures and drug therapies could be more effective, safer or more cost effective than TMR and PTMR laser systems. The market acceptance and commercial success of Eclipse and CardioGenesis TMR and PTMR laser systems will depend not only upon their safety and effectiveness, but also upon the relative safety and effectiveness of alternative treatments. ECLIPSE AND CARDIOGENESIS HAVE A HISTORY OF LOSSES AND MAY NOT BE PROFITABLE IN THE FUTURE. Eclipse and CardioGenesis cannot assure you that they will become profitable in the future. Eclipse and CardioGenesis have incurred significant losses since inception. Their revenues and operating income will be constrained: - until such time, if ever, as they obtain FDA and other regulatory approvals for their products; and - for an uncertain period of time after such approvals are obtained. The combined company may not achieve or sustain profitability in the future. IF ECLIPSE AND CARDIOGENESIS EXPERIENCE INCREASED DEMAND FOR THEIR PRODUCTS, THEY MAY NOT BE ABLE TO EXPAND THEIR BUSINESSES TO MEET SUCH DEMAND. Eclipse or CardioGenesis may be required to expand their business to: - complete the clinical trials that are currently in progress; - prepare additional products for clinical trials; - develop future products; and - generally compete successfully. Such expansion could place a significant strain on managerial, operational and financial systems and resources. To accommodate such expansion and compete effectively, Eclipse and CardioGenesis must: - improve information systems, procedures and controls; and - expand, train, motivate and manage their employees. ECLIPSE AND CARDIOGENESIS DEPEND ON SINGLE SOURCE SUPPLIERS FOR CERTAIN KEY COMPONENTS AND PRODUCTION COULD BE INTERRUPTED IF A KEY SUPPLIER HAD TO BE REPLACED. Eclipse and CardioGenesis currently purchase certain critical laser and fiber-optic components from single sources. Although each company has identified alternative suppliers, a lengthy process would be required to qualify them as additional or replacement suppliers. Any significant interruption in the supply of critical materials or components could adversely affect the ability of Eclipse or CardioGenesis to manufacture their products and could materially adversely affect 20
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their manufacturing operations, business and results of operations. Eclipse and CardioGenesis anticipate that products will be manufactured based on forecasted demand and will seek to purchase subassemblies and components in anticipation of the actual receipt of purchase orders from customers. Lead times for materials and components will vary significantly and depend on factors such as the business practices of each specific supplier and the terms of particular contracts, as well as the overall market demand for such materials and components at any given time. If the forecasts are inaccurate, Eclipse or CardioGenesis could experience fluctuations in inventory levels, resulting in excess inventory, or shortages of critical components, either of which could materially adversely affect their business and results of operations. Certain suppliers to Eclipse and CardioGenesis could have difficulty expanding their manufacturing capacity to meet the needs of Eclipse or CardioGenesis if demand for such company's TMR and PTMR laser systems were to increase rapidly or significantly. In addition, any defect or malfunction in the laser or other products provided by such suppliers could cause a delay in regulatory approvals or adversely affect product acceptance. There can be no assurance that: - materials obtained from outside suppliers will continue to be available in adequate quantities; or - alternative suppliers can be located on a timely basis. CardioGenesis purchases lasers from suppliers under OEM supply agreements. However, Eclipse and CardioGenesis generally operate on a purchase order basis with most other suppliers. Such vendors could at any time determine to cease the supply and production of such components. ECLIPSE AND CARDIOGENESIS HAVE LIMITED MANUFACTURING EXPERIENCE WHICH COULD PREVENT THEM FROM SUCCESSFULLY INCREASING CAPACITY IN RESPONSE TO MARKET DEMAND. Eclipse and CardioGenesis have limited experience in manufacturing products. Manufacturers often encounter difficulties in increasing production, including problems involving: - production yields; - adequate supplies of components; - quality control and assurance (including failure to comply with GMP regulations, international quality standards and other regulatory requirements); and - shortages of qualified personnel There can be no assurance that Eclipse or CardioGenesis: - will be able successfully to increase manufacturing capacity; or - will be able to avoid manufacturing difficulties or product recalls. ECLIPSE AND CARDIOGENESIS MUST COMPLY WITH FDA MANUFACTURING STANDARDS OR FACE FINES OR OTHER PENALTIES INCLUDING SUSPENSION OF PRODUCTION. Eclipse and CardioGenesis are required to demonstrate compliance with the FDA's current good manufacturing practices regulations if they market devices in the United States or manufacture finished devices in the United States. The FDA inspects manufacturing facilities on a regular basis to determine compliance. If they fail to comply with applicable FDA or other regulatory requirements, such company can be subject to: - fines, injunctions, and civil penalties; - recalls or seizures of products; - total or partial suspensions of production; and - criminal prosecutions. TO EXPAND THEIR BUSINESSES, ECLIPSE AND CARDIOGENESIS WILL BE REQUIRED TO ESTABLISH EFFECTIVE SALES, MARKETING AND DISTRIBUTION SYSTEMS AND THEY HAVE LIMITED EXPERIENCE TO DATE ESTABLISHING THESE OPERATIONS. To expand their business, Eclipse and CardioGenesis must establish effective systems to sell, market and distribute products. To date, Eclipse and CardioGenesis 21
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have had limited sales which have consisted primarily of sales of their TMR and PTMR laser systems for investigational use only. For this reason, they have maintained only a limited sales and marketing organization. If their laser systems receive regulatory approval, Eclipse and CardioGenesis each expect to market their products through a direct sales force and through relationships with distributors or agents. This will require substantial management efforts and financial resources. If Eclipse or CardioGenesis is not able to establish relationships with distributors, or if such distributors are not effective, their business and results of operations could be materially adversely affected. ECLIPSE AND CARDIOGENESIS MAY NEED ADDITIONAL CAPITAL OR THEY WILL BE UNABLE TO CONTINUE EXPANDING THEIR CLINICAL TRIALS AND TESTING THEIR PRODUCTS. Eclipse and CardioGenesis currently anticipate that their cash balances, together with sales of products for investigational use, will be sufficient to meet their capital requirements for the next twelve months. If either company cannot raise enough additional funds, such company may not be able to continue expanding its clinical trials and testing its products. If this were to occur, such company's business, results of operations, financial condition and prospects would be materially adversely affected. Eclipse or CardioGenesis may require additional sources of cash at an earlier date. The need for additional cash will depend upon the progress or expansion of clinical trials and any need for additional trials or other testing of products and the timing of these expenditures. Additional financing may not be available when needed or on satisfactory terms, if at all. IF CARDIOGENESIS IS NOT ABLE TO RETAIN ITS SCIENTIFIC ADVISORS IT MAY LOSE A VALUABLE SOURCE OF PRACTICAL SCIENTIFIC AND MEDICAL KNOWLEDGE. CardioGenesis has established a Scientific Advisory Board including experts in cardiac surgery, interventional cardiology, cardiology and basic science. Members of the Scientific Advisory Board consult with CardioGenesis regarding research and development efforts at CardioGenesis. The members are employed elsewhere on a full-time basis. As a result, they can only spend a limited amount of time on CardioGenesis' affairs. There can be no assurance the members of CardioGenesis' Scientific Advisory Board will continue to serve in such capacity. ECLIPSE AND CARDIOGENESIS WILL BE UNABLE TO OBTAIN FDA APPROVAL IF THEIR PRODUCTS ARE NOT PROVEN SAFE AND EFFECTIVE IN CLINICAL TESTS. The FDA has not approved Eclipse's or CardioGenesis' TMR or PTMR laser systems for any indication in the United States. There can be no assurance regarding the clinical safety or efficacy of such systems. CardioGenesis has not begun clinical trials of its TTMR laser system and there can be no assurance this system will be approved for clinical trials. Conducting TMR clinical trials will: - require substantial financial and management resources; and - take several years. Eclipse and CardioGenesis cannot assure you that their TMR and PTMR laser systems will prove to be safe or effective. The business, financial condition, and results of operations of Eclipse or CardioGenesis would be materially and adversely affected if their TMR and PTMR laser systems do not prove to be safe and effective in clinical trials. ECLIPSE AND CARDIOGENESIS MAY SUFFER LOSSES FROM PRODUCT LIABILITY CLAIMS IF THEIR PRODUCTS CAUSE HARM TO PATIENTS. Eclipse and CardioGenesis are exposed to: - potential product liability claims; and - product recalls. These risks are inherent in the design, development, manufacture and marketing of medical devices. The products of Eclipse and CardioGenesis are designed to be used in life-threatening situations where there is a high risk of serious injury or death and such companies could be subject to product liability claims if 22
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the use of their TMR or PTMR laser systems is alleged to have caused adverse effects on a patient or such products are believed to be defective. Any regulatory clearance for commercial sale of these products will not remove these risks. Any failure to comply with the FDA's GMP or other regulations could have a material adverse effect on the ability of Eclipse or CardioGenesis to defend against product liability lawsuits. Although neither company has experienced any product liability claims to date, any such claims could have a material adverse effect on their business, financial condition and results of operations. OUR INSURANCE MAY BE INSUFFICIENT TO COVER PRODUCT LIABILITY CLAIMS AGAINST US. There can be no assurance that the product liability insurance maintained by Eclipse or CardioGenesis will: - be adequate for any future product liability problems; or - that such insurance coverage will continue to be available on commercially reasonable terms, or at all. If such company were held liable for a product liability claim or series of claims in excess of its insurance coverage, such liability could have a material and adverse effect on such company's business, financial condition and results of operations. Eclipse maintains insurance against product liability claims in the amount of: - $10 million per occurrence; and - $10 million in the aggregate. CardioGenesis has coverage limits of: - $5 million per occurrence and in the aggregate; and - additional coverage limits of deutsche mark 1 million (approximately $546,000) per person and deutsche mark 50 million (approximately $27,300,000) in the aggregate for use of CardioGenesis' TMR laser systems in Germany. These coverage limits may not adequately protect Eclipse or CardioGenesis from liabilities they might incur in connection with the development, manufacture and sale of their products since: - TMR technology is not well understood; and - there is a lack of data regarding the clinical safety and efficacy of TMR laser systems. Eclipse or CardioGenesis may require increased product liability coverage if any products are commercialized. Product liability insurance is expensive and in the future may not be available on acceptable terms, if at all. ECLIPSE AND CARDIOGENESIS MAY EXPERIENCE ADVERSE EFFECTS ON THEIR BUSINESSES RELATED TO YEAR 2000 ISSUES AFFECTING THEIR SUPPLIERS. Many currently installed computer systems and software products experience functional difficulty distinguishing between twenty-first century dates and twentieth century dates. This is commonly known as the Year 2000 Problem. As a result, many companies' software and computer systems may need to be upgraded or replaced in order to function properly in the future. As the products that Eclipse itself supplies to its customers are not dependent upon date data processing and do not have electrical ports for the connection of other devices, Eclipse believes that these products are Year 2000 compliant. Eclipse does not anticipate any material disruption in its operations as a result of any internal or external Year 2000 compliance problems. However, Eclipse expects to prepare for minor delays in the receipt of materials and services as a result of third parties' failures to meet Year 2000 requirements. Eclipse cannot assure you that it will not experience unexpected delays or problems as a result of Year 2000 problems. Eclipse is also working with its suppliers to ensure that its suppliers are Year 2000 compliant. If Eclipse is not able to procure 23
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adequate supplies, it will not be able to manufacture and sell its products, which would have a significant material adverse effect on its business and results of operations. Eclipse believes that the foregoing describes its most reasonably likely worst case Year 2000 scenario. For a description of Year 2000 issues related to CardioGenesis, see page 108. THE OPERATING RESULTS OF ECLIPSE AND CARDIOGENESIS ARE EXPECTED TO FLUCTUATE AND QUARTER TO QUARTER COMPARISONS OF THEIR RESULTS MAY NOT INDICATE FUTURE PERFORMANCE. The operating results of Eclipse and CardioGenesis have fluctuated significantly from quarter to quarter and are expected to fluctuate significantly from quarter to quarter due to a number of events and factors, including: - the timing and results of clinical trials; - delays associated with the FDA and other regulatory approval processes; - the enactment of health care reform legislation and any changes in third party reimbursement policies; - the level of product demand and the timing of customer orders; - changes in competitive pricing policies; - the ability to develop, introduce and market new and enhanced versions of products on a timely basis; - deferrals in customer orders in anticipation of new or enhanced products; - product quality problems; - personnel changes; - changes in strategy; and - the level of international sales. Eclipse and CardioGenesis believe that quarter to quarter comparisons of their operating results may not be a good indication of their future performance. It is likely that the operating results of Eclipse or CardioGenesis for a future quarter will fall below the expectations of public market analysts and investors. If this occurs, the price of such company's common stock may fall, perhaps substantially. ECLIPSE AND CARDIOGENESIS MAY NOT BE ABLE TO SUCCESSFULLY MARKET THEIR PRODUCTS IF THEY FAIL TO OBTAIN THIRD PARTY REIMBURSEMENT FOR THE PROCEDURES PERFORMED WITH THEIR PRODUCTS. Few individuals are able to pay directly for the costs associated with the use of the products of Eclipse and CardioGenesis. In the United States, hospitals, physicians and other health care providers that purchase medical devices generally rely on third party payors, such as Medicare, to reimburse all or part of the cost of the procedure in which the medical device is being used. A failure by third party payors to provide adequate reimbursement for the TMR and PTMR procedures that use Eclipse or CardioGenesis products would have a material adverse effect on such company's business, financial condition, and results of operations. Although Eclipse and CardioGenesis do not anticipate receiving reimbursements for their laser systems from Medicare during their clinical trials, they will seek reimbursement from other third party payors. There can be no assurance, however, that such reimbursement will be available. Third party payors may deny reimbursement if they determine that the device used in a treatment is: - unnecessary, - inappropriate; - experimental; - used for a non-approved indication; or - not cost-effective. Potential purchasers must determine whether the clinical benefits of Eclipse and CardioGenesis TMR and PTMR laser systems justify: - the additional cost or the additional effort required to obtain prior authorization or coverage; and - the uncertainty of actually obtaining such authorization or coverage. 24
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ECLIPSE AND CARDIOGENESIS MAY NOT ACHIEVE WIDE ACCEPTANCE OF THEIR PRODUCTS IN FOREIGN MARKETS IF THEY FAIL TO OBTAIN THIRD PARTY REIMBURSEMENT FOR THE PROCEDURES PERFORMED WITH THEIR PRODUCTS. If Eclipse or CardioGenesis obtains the necessary foreign regulatory registrations or approvals, market acceptance of such company's products in international markets would be dependent, in part, upon the availability of reimbursement within prevailing health care payment systems. Reimbursement and health care payment systems in international markets vary significantly by country. They include both government sponsored health care and private insurance. Although Eclipse and CardioGenesis expect to seek international reimbursement approvals, there can be no assurance any such approvals will be obtained in a timely manner, if at all. Failure to receive international reimbursement approvals could have a material adverse effect on market acceptance of TMR products in the international markets in which such approvals are sought. OVERALL INCREASES IN MEDICAL COSTS COULD ADVERSELY AFFECT OUR BUSINESS. Eclipse and CardioGenesis believe that the overall escalating cost of medical products and services has led, and will continue to lead, to increased pressures on the health care industry, both foreign and domestic, to reduce the cost of products and services, including products offered by them. There can be no assurance in either United States or international markets that: - third party reimbursement and coverage will be available or adequate; - current reimbursement amounts will not be decreased in the future; or - future legislation, regulation or reimbursement policies of third party payors will not otherwise adversely affect the demand for or the ability of Eclipse and CardioGenesis to profitably sell their products. Fundamental reforms in the healthcare industry in the United States and Europe continue to be considered. Eclipse and CardioGenesis cannot predict whether or when any healthcare reform proposals will be adopted and what effect such proposals might have on their businesses. 25
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COMPARATIVE MARKET PRICE DATA The table below sets forth, for the calendar quarters indicated, the high and low closing prices of Eclipse common stock and CardioGenesis common stock as reported on Nasdaq. Eclipse effected the initial public offering of its common stock on May 31, 1996 and CardioGenesis effected the initial public offering of its common stock on May 22, 1996. · Download Table ECLIPSE COMMON CARDIOGENESIS STOCK COMMON STOCK ------------------ ------------------ HIGH LOW HIGH LOW ------- ------- ------- ------- 1996 CALENDAR YEAR Second Quarter........................ $16.50 $12.75 $20.75 $ 13.50 Third Quarter......................... 14.00 7.50 14.75 9.50 Fourth Quarter........................ 13.125 8.00 13.625 10.75 1997 CALENDAR YEAR First Quarter......................... 9.50 5.625 17.50 11.50 Second Quarter........................ 8.00 5.00 13.00 7.25 Third Quarter......................... 9.625 7.00 13.625 9.75 Fourth Quarter........................ 9.00 5.50 12.50 5.375 1998 CALENDAR YEAR First Quarter......................... 12.938 5.875 9.25 6.50 Second Quarter........................ 12.875 9.375 7.875 4.25 Third Quarter......................... 10.125 5.625 5.563 2.125 Fourth Quarter........................ 10.25 6.3125 6.438 1.75 1999 CALENDAR YEAR First Quarter (through February 8, 1999).............................. 12.688 7.375 9.75 5.25 On October 21, 1998, the last full trading day prior to the public announcement of the execution and delivery of the reorganization agreement, the closing prices on Nasdaq were $8.7813 per share of Eclipse common stock and $2.2188 per share of CardioGenesis common stock. On February 8, 1999, the closing prices on Nasdaq were $12.625 per share of Eclipse common stock and $9.5625 per share of CardioGenesis common stock. Because the exchange ratio for the merger is fixed, changes in the market price of Eclipse common stock will affect the dollar value of the shares of Eclipse common stock to be received by CardioGenesis stockholders in the merger. Eclipse shareholders and CardioGenesis stockholders are urged to obtain current market quotations for Eclipse common stock and CardioGenesis common stock prior to the special meetings. Neither Eclipse nor CardioGenesis has ever paid cash dividends. Eclipse and CardioGenesis anticipate that the combined company will retain earnings for development of its business and will not distribute earnings to shareholders as dividends. The declaration and payment by the combined company of any future dividends and the amount thereof will depend upon the combined company's results of operations, financial condition, cash requirements, future prospects, limitations imposed by credit agreements or senior securities and other factors deemed relevant by its Board of Directors. 26
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WHERE YOU CAN FIND MORE INFORMATION Eclipse and CardioGenesis file annual, quarterly and special reports, proxy statements and other information with the SEC. You may inspect and copy such material at the public reference facilities maintained by the SEC at Room 1024, 450 Fifth Street, N.W., Washington, D.C. 20549, as well as at the SEC's regional offices at 500 West Madison Street, Suite 1400, Chicago, Illinois 60661 and 7 World Trade Center, Suite 1300, New York, New York 10048. You may also obtain copies of such material from the SEC at prescribed rates by writing to the Public Reference Section of the SEC, 450 Fifth Street, N.W., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for more information on the public reference rooms. You can also find our SEC filings at the SEC's website at www.sec.gov, or additional corporate information at Eclipse's website at www.eclipsesurg.com and CardioGenesis' website at www.cardiogenesis.com. Information found at the Eclipse website or the CardioGenesis website is not deemed to be a part of this joint proxy statement/prospectus. Eclipse common stock and CardioGenesis common stock are quoted on the Nasdaq National Market and such reports, proxy statements and other information can also be inspected at the offices of the National Association of Securities Dealers, Inc. located at 9513 Key West Avenue, Rockville, Maryland 20850. After the consummation of the merger, CardioGenesis will no longer file reports, proxy statements or other information with the SEC or Nasdaq. Instead such information will be provided, to the extent required, in filings made by Eclipse. Eclipse was incorporated in California in April 1989. CardioGenesis was incorporated in California in September 1993 and changed its state of incorporation to Delaware in May 1996. INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE Eclipse is "incorporating by reference" into this joint proxy statement/prospectus the information contained in documents that it files with the SEC, which means that Eclipse can disclose important information to you by referring you to those documents. The information incorporated by reference is considered to be part of this joint proxy statement/prospectus. Information in this joint proxy statement/prospectus supersedes information incorporated by reference that Eclipse filed with the SEC prior to the date of this joint proxy statement/prospectus, while information that Eclipse files later with the SEC will automatically update and supersede this information. Eclipse incorporates by reference the documents listed below and any future filings it will make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934 subsequent to the date of this joint proxy statement/prospectus: - Eclipse's Annual Report on Form 10-K for the fiscal year ended December 31, 1997; - The description of Eclipse common stock contained in its Registration Statement on Form 8-A filed with the SEC on April 18, 1996; - Eclipse's Definitive Proxy Statement on Schedule 14A dated March 25, 1998; - Eclipse's Quarterly Reports on Form 10-Q for the quarters ended March 31, 1998, June 30, 1998 and September 30, 1998; 27
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- Eclipse's Current Report on Form 8-K dated November 3, 1998; and - Eclipse's Current Report on Form 8-K dated December 11, 1998. You may request a copy of any of these Eclipse filings, at no cost to you, by writing or telephoning Eclipse at: Eclipse Surgical Technologies, Inc. Attention: Investor Relations 1049 Kiel Court Sunnyvale, CA 94089 Telephone (408) 747-0120 YOU SHOULD MAKE YOUR REQUEST BY MARCH 10, 1999 TO ENSURE DELIVERY OF ANY OF THE ABOVE DOCUMENTS PRIOR TO YOUR SPECIAL MEETING. You should rely only on the information provided or incorporated by reference in this joint proxy statement/prospectus. We have authorized no one to provide you with different information. You should not assume that the information in this joint proxy statement/ prospectus is accurate as of any date other than the date on the front of the document. FORWARD-LOOKING STATEMENTS We have each made forward-looking statements in this joint proxy statement/prospectus (and Eclipse has made forward-looking statements in the documents that are incorporated by reference in this joint proxy statement/prospectus) that are subject to risks and uncertainties. Forward-looking statements include information concerning possible or assumed future results of operations of Eclipse, CardioGenesis or the combined company. Also, when we use words such as "believes," "expects," "anticipates" or similar expressions, we are making forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. You should note that the merger and an investment in securities of Eclipse involve certain risks and uncertainties that could affect the future financial results of Eclipse. Some of these risks include: risks related to the integration of Eclipse and CardioGenesis, risks associated with a fixed exchange ratio, risks relating to the respective businesses of Eclipse and CardioGenesis and other risks and uncertainties discussed under "Risk Factors" and elsewhere in this joint proxy statement/prospectus and in the Eclipse documents incorporated by reference. For more information on these risks, see "Risk Factors" beginning on page 12. This joint proxy statement/prospectus contains trademarks of Eclipse and CardioGenesis and may contain trademarks of others. 28
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ECLIPSE SPECIAL MEETING DATE, TIME AND PLACE OF ECLIPSE SPECIAL MEETING The Eclipse special meeting will be held at Eclipse's headquarters at 1049 Kiel Court, Sunnyvale, California 94089, on Wednesday, March 17, 1999 at 9:00 a.m. local time. PURPOSE The purpose of the Eclipse special meeting is to approve the reorganization agreement including the issuance of shares of Eclipse common stock to the CardioGenesis stockholders in the merger. RECORD DATE AND OUTSTANDING SHARES The Eclipse Board has fixed February 8, 1999 as the record date for the Eclipse special meeting. Only Eclipse shareholders of record on the record date are entitled to notice of and to vote at the Eclipse special meeting. As of the record date, there were approximately 178 shareholders of record holding an aggregate of approximately 17,621,323 shares of Eclipse common stock. VOTE REQUIRED AND VOTING RIGHTS Under California law and the charter documents of Eclipse, approval of the reorganization agreement including the issuance of shares of Eclipse common stock in the merger requires the affirmative vote of at least a majority of the shares of Eclipse common stock outstanding on the record date. Each shareholder of record of Eclipse common stock on the record date is entitled to cast one vote per share, exercisable in person or by properly executed proxy, on each matter properly submitted for the vote of the shareholders of Eclipse at the Eclipse special meeting. The presence, in person or by properly executed proxy, of the holders of at least a majority of the outstanding shares of Eclipse common stock entitled to vote at the Eclipse special meeting will constitute a quorum. Broker non-votes and shares held by persons abstaining will be counted in determining whether a quorum is present at the Eclipse special meeting. For the Eclipse proposal, abstentions are counted as votes cast and accordingly have the same effect as votes against the proposal, whereas broker non-votes are not counted as votes cast and therefore once a quorum is present, will have no effect on the proposal. The members of the Eclipse Board and certain executive officers of Eclipse, who together beneficially hold approximately 28% of the Eclipse common stock outstanding as of the record date, have entered into voting agreements with CardioGenesis, in which they have agreed, in their capacity as a shareholder of Eclipse, to vote in favor of the issuance of Eclipse common stock in the merger and have granted CardioGenesis an irrevocable proxy. PROXIES Each of the persons named in the Eclipse proxy as a proxy holder is an officer of Eclipse. All shares of Eclipse common stock that are entitled to vote and are represented at the Eclipse special meeting either in person or by properly executed proxies received prior to or at the Eclipse special meeting and not duly and timely revoked will be voted at the Eclipse special meeting according to the instructions indicated on such proxies. If no such 29
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instructions are indicated, such proxies will be voted for approval of the reorganization agreement including the issuance of shares of Eclipse common stock in the merger. Any proxy given in this solicitation may be revoked by the person giving it at any time before it is voted. Proxies may be revoked by: - filing with the Secretary of Eclipse at or before the taking of the vote at the Eclipse special meeting, a written notice of revocation bearing a later date than the proxy; - duly executing a later-dated proxy relating to the same shares and delivering it to the Secretary of Eclipse before the taking of the vote at the Eclipse special meeting; or - attending the Eclipse special meeting and voting in person (although attendance at the Eclipse special meeting will not in and of itself constitute a revocation of a proxy). Any written notice of revocation or later-dated proxy should be sent so as to be delivered to Eclipse at 1049 Kiel Court, Sunnyvale, California 94089, Attention: Secretary, or hand-delivered to the Secretary of Eclipse, in each case at or before the taking of the vote at the Eclipse special meeting. SOLICITATION OF PROXIES; EXPENSES Eclipse will bear all costs of soliciting proxies for the Eclipse special meeting, except that Eclipse and CardioGenesis have each agreed to pay one-half of the filing and printing costs associated with this joint proxy statement/prospectus. In addition, Eclipse may reimburse brokerage firms and other persons representing beneficial owners of shares for their expenses in forwarding solicitation materials to such beneficial owners. Proxies may also be solicited by certain Eclipse directors, officers and regular employees personally or by telephone, telegram, letter or facsimile. Such persons will not receive additional compensation, but may be reimbursed for reasonable out-of-pocket expenses incurred in connection with such solicitation. In addition, Eclipse has retained Morrow & Co. to assist in the solicitation of proxies from brokers, nominees, institutions and individuals at an estimated fee of $6,000 plus reimbursement of reasonable expenses. Arrangements will also be made with custodians, nominees and fiduciaries for forwarding of proxy solicitation materials to beneficial owners of shares held of record by such entities, and Eclipse will reimburse such entities for reasonable expenses incurred in connection therewith. INDEPENDENT ACCOUNTANTS One or more representatives of PricewaterhouseCoopers LLP, independent accountants for Eclipse, are expected to be present at the Eclipse special meeting and will have an opportunity to make a statement if they desire to do so and will be available to respond to appropriate questions. RECOMMENDATION OF THE ECLIPSE BOARD THE ECLIPSE BOARD HAS UNANIMOUSLY APPROVED THE REORGANIZATION AGREEMENT AND THE MERGER AND HAS DETERMINED THAT THE MERGER IS FAIR TO, AND IN THE BEST INTERESTS OF, ECLIPSE AND ITS SHAREHOLDERS. AFTER CAREFUL CONSIDERATION, THE ECLIPSE BOARD UNANIMOUSLY RECOMMENDS A VOTE IN FAVOR OF THE APPROVAL OF THE REORGANIZATION AGREEMENT INCLUDING THE ISSUANCE OF SHARES OF ECLIPSE COMMON STOCK IN THE MERGER. 30
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CARDIOGENESIS SPECIAL MEETING DATE, TIME AND PLACE OF CARDIOGENESIS SPECIAL MEETING The CardioGenesis special meeting will be held at CardioGenesis' headquarters at 540 Oakmead Parkway, Sunnyvale, California, on Wednesday, March 17, 1999 at 9:00 a.m. local time. PURPOSE The purpose of the CardioGenesis special meeting is to approve and adopt the reorganization agreement and to approve the merger. CardioGenesis stockholders may also consider and vote upon such other matters as may properly come before the CardioGenesis special meeting or any adjournments of the meeting. RECORD DATE AND OUTSTANDING SHARES The CardioGenesis Board has fixed February 8, 1999 as the record date for the CardioGenesis special meeting. Only stockholders of record of CardioGenesis common stock on the record date are entitled to notice of, and to vote at, the CardioGenesis special meeting. As of the record date, there were 88 stockholders of record holding an aggregate of 12,385,051 shares of CardioGenesis common stock. VOTE REQUIRED AND VOTING RIGHTS The affirmative vote of the holders of at least a majority of the CardioGenesis common stock outstanding as of the record date is required to approve and adopt the reorganization agreement and approve the merger, according to the requirements of Delaware law and CardioGenesis' restated certificate of incorporation. Each stockholder of record of CardioGenesis common stock on the record date, will be entitled to cast one vote per share on each matter to be acted upon at the CardioGenesis special meeting. The representation, in person or by proxy, of at least a majority of the outstanding shares of CardioGenesis common stock entitled to vote at the CardioGenesis special meeting is necessary to constitute a quorum for the transaction of business. The effect of an abstention or a broker non-vote is the same as a vote against the proposal for purposes of obtaining the required vote of a majority of the outstanding shares of CardioGenesis common stock to approve and adopt the reorganization agreement and approve the merger. Certain CardioGenesis directors and certain executive officers of CardioGenesis, who together hold approximately 29% of the CardioGenesis common stock outstanding as of the record date, have entered into voting agreements with Eclipse in which they have agreed to vote in favor of the approval of the reorganization agreement and approval of the merger and have granted Eclipse an irrevocable proxy. PROXIES Each of the persons named in the CardioGenesis proxy as a proxy holder is an officer of CardioGenesis. All shares of CardioGenesis common stock that are entitled to vote and are represented at the CardioGenesis special meeting either in person or by properly executed proxies received prior to or at the CardioGenesis special meeting and not duly and timely revoked will be voted at the CardioGenesis special meeting according to the instructions 31
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indicated on such proxies. If no such instructions are indicated, such proxies will be voted for the approval and adoption of the reorganization agreement and approval of the merger. If any other matters are properly presented for consideration at the CardioGenesis special meeting, including a motion to adjourn the CardioGenesis special meeting to another time or place (including for purposes of soliciting additional proxies), unless otherwise indicated on a proxy, the person named as proxy and acting thereunder will have the discretion to vote on such matters in accordance with his or her best judgement. Such person will not vote any proxy that votes against the reorganization agreement and the merger in favor of a motion to adjourn the special meeting for purposes of soliciting additional proxies. Any proxy given pursuant to this solicitation may be revoked by the person giving it at any time before it is voted. Proxies may be revoked by: - filing with the Secretary of CardioGenesis at or before the taking of the vote at the CardioGenesis special meeting, a written notice of revocation bearing a later date than the proxy; - duly executing a later-dated proxy relating to the same shares and delivering it to the Secretary of CardioGenesis before the taking of the vote at the CardioGenesis special meeting; or - attending the CardioGenesis special meeting and voting in person (although attendance at the CardioGenesis special meeting will not in and of itself constitute a revocation of a proxy). Any written notice of revocation or later-dated proxy should be sent so as to be delivered to CardioGenesis at 540 Oakmead Parkway, Sunnyvale, California 94086, Attention: Secretary, or hand-delivered to the Secretary of CardioGenesis, in each case at or before the taking of the vote at the CardioGenesis special meeting. SOLICITATION OF PROXIES; EXPENSES CardioGenesis will bear all costs of soliciting proxies for the CardioGenesis special meeting, except that Eclipse and CardioGenesis have each agreed to pay one-half of the filing and printing costs associated with this joint proxy statement/prospectus. In addition, CardioGenesis may reimburse brokerage firms and other persons representing beneficial owners of shares for their expenses in forwarding solicitation materials to such beneficial owners. Proxies may also be solicited by certain CardioGenesis directors, officers and regular employees personally or by telephone, telegram, letter or facsimile. Such persons will not receive additional compensation, but may be reimbursed for reasonable out-of- pocket expenses incurred in connection with such solicitation. In addition, CardioGenesis has retained MacKenzie Partners, Inc. to assist in the solicitation of proxies from brokers, nominees, institutions and individuals at an estimated fee of $10,000 plus reimbursement of reasonable expenses. Arrangements will also be made with custodians, nominees and fiduciaries for forwarding of proxy solicitation materials to beneficial owners of shares held of record by such entities, and CardioGenesis will reimburse such entities for reasonable expenses incurred in the proxy solicitation. INDEPENDENT ACCOUNTANTS One or more representatives of PricewaterhouseCoopers LLP, independent accountants for CardioGenesis, are expected to be present at the CardioGenesis special meeting and will 32
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have an opportunity to make a statement if they desire to do so and will be available to respond to appropriate questions. RECOMMENDATION OF THE CARDIOGENESIS BOARD THE CARDIOGENESIS BOARD HAS UNANIMOUSLY APPROVED THE REORGANIZATION AGREEMENT AND THE MERGER AND HAS DETERMINED THAT THE MERGER IS FAIR TO, AND IN THE BEST INTERESTS OF, CARDIOGENESIS AND ITS STOCKHOLDERS. AFTER CAREFUL CONSIDERATION, THE CARDIOGENESIS BOARD UNANIMOUSLY RECOMMENDS A VOTE IN FAVOR OF APPROVAL AND ADOPTION OF THE REORGANIZATION AGREEMENT AND APPROVAL OF THE MERGER. CARDIOGENESIS STOCKHOLDERS SHOULD NOT SEND ANY STOCK CERTIFICATES WITH THEIR PROXY CARDS. 33
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APPROVAL OF THE MERGER AND RELATED TRANSACTIONS Certain statements made in this section are forward-looking statements. For a discussion of forward-looking statements, see page 28. JOINT REASONS FOR THE MERGER The Boards of Directors of Eclipse and CardioGenesis believe that by combining the complementary product lines of the two companies, the combined company would have the potential to realize long-term improved operating and financial results and a stronger position in the industry. Eclipse and CardioGenesis have each identified reasons for the merger, which are discussed below. In addition, the Eclipse Board and the CardioGenesis Board believe the following are reasons why the merger will be beneficial to both companies and their shareholders: - Eclipse and CardioGenesis believe that the business combination of Eclipse and CardioGenesis will create a leading provider of TMR laser systems employing a fiber optic platform with a significant clinical/regulatory lead over competitors. - Eclipse and CardioGenesis believe that their respective product lines are complementary and that the combined company can offer products designed with the best features of each company's approach to TMR procedures. - Eclipse and CardioGenesis estimate that the combined company will have a much larger installed base of products many of which will be installed at leading cardiological and cardiac surgery centers in the United States. - Eclipse and CardioGenesis believe that the combined company will have a substantial opportunity to consolidate their respective ongoing clinical trials and product development activities and reduce associated expenses. - Eclipse and CardioGenesis believe that the combined company will possess a significant proprietary patent position, supplementing Eclipse's issued patents with those of CardioGenesis. - Eclipse and CardioGenesis expect that the combined company will be able to achieve substantial benefits and considerable efficiencies from a single manufacturing plant that produces at higher manufacturing volumes and that absorbs manufacturing overhead to improve operating margins. - Eclipse and CardioGenesis believe the transaction will create potential annual cost savings of approximately $14.6 million. Annual cost savings in manufacturing are estimated to be $1.4 million consisting of reduced facilities and depreciation costs of $600,000 and salary and fringe benefits savings of $800,000. Estimated annual savings in the research and development and clinical and regulatory areas of $11.3 million consist of $10.0 million of reduced costs paid to outside parties related primarily to conducting and monitoring clinical trials, $1.2 million in savings related to salaries and fringe benefits and $100,000 of reduced depreciation costs. Estimated annual cost savings in general and administrative, and marketing and sales of approximately $1.9 million consist of $1.2 million in savings related to salaries and fringe benefits, $400,000 in reduced facilities and depreciation costs and $300,000 in reduced advertising costs. The figures above are annual amounts. Based upon the 34
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anticipated closing date of the merger, the combined company expects to realize cost savings of approximately $10.9 million during fiscal year 1999. - Eclipse shareholders and CardioGenesis stockholders will have the ability to participate in the potential for growth of the combined company. Each Board of Directors recognizes that the ability of the combined company to realize the potential benefits of the merger is subject to a number of risks including those discussed on pages 12 through 25. ECLIPSE'S ADDITIONAL REASONS FOR THE MERGER On October 21, 1998, the Eclipse Board determined the merger to be advisable and fair and in the best interests of Eclipse and its shareholders and approved the reorganization agreement and the merger. The Eclipse Board unanimously recommends that the Eclipse shareholders vote FOR the approval of the reorganization agreement including the issuance of shares of Eclipse common stock in the merger. In addition to the joint benefits described above, in the course of its deliberations the Eclipse Board considered a number of factors relating to the merger, including the following: - historical information concerning Eclipse's and CardioGenesis' respective businesses, prospects, financial performance and condition, operations, technology, management and competitive position, including public reports concerning results of operations during the most recent fiscal year and fiscal quarter for each company filed with the SEC; - Eclipse management's view of the financial condition, results of operations and businesses of Eclipse and CardioGenesis before and after giving effect to the merger; - current financial market conditions and historical market prices, volatility and trading information with respect to Eclipse common stock and CardioGenesis common stock; - the consideration to be received by CardioGenesis stockholders in the merger, the relationship between the market value of the Eclipse common stock to be issued in exchange for each share of CardioGenesis common stock, the market value of the CardioGenesis common stock and a comparison of comparable merger transactions; - the belief that the terms of the reorganization agreement, including the parties' representations, warranties and covenants, and the conditions to their respective obligations, are reasonable; - Eclipse management's view of the prospects of Eclipse as an independent company; - the likelihood that in the future another party could enter into a strategic relationship with or acquire CardioGenesis if the merger were not undertaken; - the financial analysis performed by PaineWebber presented at Eclipse Board meetings on October 18, 1998 and October 21, 1998. This analysis is described on page 48 and was the basis for PaineWebber's opinion, dated October 21, 1998, that, as of such date, the exchange ratio was fair, from a financial point of view, to Eclipse; 35
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- the expected impact of the merger on Eclipse's customers and employees; - reports from Eclipse management, legal and financial advisors as to the results of their due diligence investigation of CardioGenesis; and - the expectation that the merger will be accounted for as a pooling of interests. The Eclipse Board also identified and considered a variety of potentially negative factors in its deliberations concerning the merger, including: - the risk that the potential benefits sought in the merger might not be fully realized; - the possibility that the merger might not be consummated and the effect of public announcement of the merger on (a) Eclipse's sales and operating results, (b) Eclipse's ability to attract and retain key management and technical personnel and (c) progress of certain development projects; - the potential dilutive effect of the issuance of Eclipse common stock in the merger; - charges estimated at $4.0 to 6.0 million to be incurred in connection with the merger, including costs of integrating the businesses and transaction expenses arising from the merger; and - the risk that despite the efforts of the combined company, key technical and management personnel might not remain employed by the combined company, and that product lines and sales channels might not be timely or well integrated. The foregoing discussion of the benefits and factors considered by the Eclipse Board is not intended to be exhaustive, but summarizes all material benefits and factors considered. The Eclipse Board did not find it practicable in view of the wide variety of factors it considered to quantify or otherwise assign relative weight to the specific factors considered. However, after taking into account all of the factors above, the Eclipse Board determined unanimously that the merger was fair and in the best interests of Eclipse and its shareholders and that Eclipse should proceed with the merger and the reorganization agreement. CARDIOGENESIS' ADDITIONAL REASONS FOR THE MERGER On October 21, 1998, the CardioGenesis Board determined the merger to be advisable and fair to, and in the best interests of, CardioGenesis and the CardioGenesis stockholders and approved the reorganization agreement and the merger. The CardioGenesis Board unanimously recommends that the CardioGenesis stockholders vote FOR the proposal to approve and adopt the reorganization agreement and approve the merger. In addition to the joint benefits described above, in the course of its deliberations during CardioGenesis Board meetings held on October 12, 1998 and October 21, 1998, the CardioGenesis Board reviewed with CardioGenesis management a number of additional factors relevant to the merger, including the strategic overview and prospects for CardioGenesis, its products and its finances. At the October 21, 1998 meeting, the CardioGenesis Board considered a financial presentation by Bear Stearns, including the opinion of Bear Stearns, which concluded that the exchange ratio was fair, from a financial point of view, to the public stockholders of CardioGenesis on such date (a copy of which is attached as Appendix C). 36
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The CardioGenesis Board also considered, among other matters: - historical information concerning CardioGenesis' and Eclipse's respective businesses, prospects, financial performance and condition, operations, technology, management and competitive position, including public reports concerning results of operations during the most recent fiscal year and fiscal quarter for each company with the SEC; - CardioGenesis management's view as to the financial condition, results of operations and businesses of Eclipse and CardioGenesis before and after giving effect to the merger, based on management due diligence and publicly available financial information; - current financial market conditions and historical market prices, volatility and trading information with respect to Eclipse common stock and CardioGenesis common stock; - the consideration to be received by CardioGenesis stockholders in the merger and the relationship between the market value of the Eclipse common stock to be issued in exchange for each share of CardioGenesis common stock and a comparison of comparable merger transactions; - the tax and accounting treatments to be accorded the merger and the pro forma effect of same on the combined company; - CardioGenesis management's view as to the prospects of CardioGenesis as an independent company; - CardioGenesis management's view as to the potential for other parties to enter into strategic relationships with or to acquire Eclipse if the merger was not undertaken; - the impact of the merger on CardioGenesis' customers and employees; and - reports from CardioGenesis management, legal and financial advisors as to the results of their due diligence investigation of Eclipse. The CardioGenesis Board considered generally the material terms of the merger and concluded that such terms were appropriate for a transaction of that type. The CardioGenesis Board also considered CardioGenesis' and Eclipse's respective rights to consider and negotiate other acquisition proposals in certain circumstances, as well as the possible effects of the provisions regarding termination fees. The CardioGenesis Board took note of the fact that the reorganization agreement provides for a fixed exchange ratio, which posed some risk to CardioGenesis stockholders in the event of a decline in the value of Eclipse common stock. If such a decline occurred, the exchange ratio might represent less of a premium over the market price of CardioGenesis common stock than it represented on October 21, 1998. However, the CardioGenesis Board concluded that, from a long-range perspective, as distinguished from the market price of the Eclipse common stock on any given date, the exchange ratio represented an attractive price for CardioGenesis, in part, because it preserved the "upside" opportunity to benefit from any future increase in the market price of Eclipse common stock, whether due to the combination of the two companies or otherwise. Based on its familiarity with the medical device industry generally and information available to it with respect to Eclipse specifically, the CardioGenesis Board determined that the benefits of a fixed 37
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exchange ratio at least equaled, and possibly outweighed, the risks of such a pricing mechanism. The CardioGenesis Board also identified and considered a number of other potentially negative factors in its deliberations concerning the merger, including: - the risk that the potential benefits sought in the merger might not be fully realized; - the possibility that the merger would not be consummated and the effect of the public announcement of the merger on (a) CardioGenesis' sales and operating results, (b) CardioGenesis' ability to attract and retain key management, marketing and technical personnel, and (c) progress of certain development projects; - charges estimated at $4.0 to 6.0 million to be incurred in connection with the merger, including costs of integrating the businesses and transaction expenses arising from the merger; and - the risk that despite the efforts of the combined company, key technical and management personnel may not remain employed by the combined company. The CardioGenesis Board believed that these risks were outweighed by the potential benefits of the merger. See "Risk Factors -- Risks Related to the Merger." The foregoing discussion of benefits and factors considered by the CardioGenesis Board is not intended to be exhaustive, but summarizes all material benefits and factors considered. The CardioGenesis Board did not assign any relative or specific weights to the foregoing factors nor did it specifically characterize any factor as positive or negative (except as described above), and individual directors may have given differing weights to different factors and may have viewed certain factors more positively or negatively than others. Throughout its deliberations, the CardioGenesis Board received the advice of Heller Ehrman White & McAuliffe, its legal advisor, and Bear Stearns, its financial advisor. THE CARDIOGENESIS BOARD UNANIMOUSLY RECOMMENDS THAT CARDIOGENESIS STOCKHOLDERS APPROVE THE REORGANIZATION AGREEMENT AND THE MERGER. MATERIAL CONTACTS AND BOARD DELIBERATIONS In January 1998, Douglas Murphy-Chutorian, M.D., Chairman of the Board and Chief Executive Officer of Eclipse, contacted Allen W. Hill, President and Chief Executive Officer of CardioGenesis, and had a preliminary conversation concerning industry issues and generally regarding the possibility of a business combination. Mr. Hill advised the CardioGenesis Board of his conversation with Dr. Murphy-Chutorian. No further discussions were held between the parties. In late August 1998, Dr. Murphy-Chutorian contacted Mr. Hill to determine whether CardioGenesis might be interested in a possible business combination between Eclipse and CardioGenesis. As a result of this conversation, Dr. Murphy-Chutorian and Mr. Hill met later in August 1998 and discussed the business objectives of each of Eclipse and CardioGenesis. They also discussed a possible business combination between the two companies and focused on the strengths and weaknesses of each company and the attributes, potential benefits and synergies of a business combination. Dr. Murphy-Chutorian and Mr. Hill agreed to report on the discussions at this meeting to their respective Boards of Directors. 38
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On September 1, 1998, the Eclipse Board held a meeting at which a possible business combination with CardioGenesis was discussed. At this meeting, the Board directed management to invite Mr. Hill to make a presentation to the Eclipse Board. On September 10 and September 16, 1998, Mr. Hill and Richard Powers, CardioGenesis' Chief Financial Officer, Executive Vice President of Finance and Administration, and Dr. Murphy-Chutorian and Richard Mueller, Eclipse's President and Chief Operating Officer, made presentations of non-confidential information to the Eclipse Board and the CardioGenesis Board, respectively, that included a description of each company's products, customer base and history. Each presentation included a discussion of each company's financial results for its current fiscal year through June 30, 1998 and the potential benefits and risks of a strategic combination of Eclipse and CardioGenesis. Following each presentation, each Board discussed at length a possible business combination of Eclipse and CardioGenesis, including the potential terms of such a transaction. Thereafter, each Board authorized its management to proceed with further discussions and to commence a more comprehensive review of the other company. Each Board also directed its management to engage an investment banking firm to render a fairness opinion with respect to a transaction, in the case of Eclipse, and to act as financial advisor, in the case of CardioGenesis, and to consult with their respective legal counsel regarding the structure and timing of a possible transaction. During the weeks of September 13 and September 20, 1998, Dr. Murphy-Chutorian, Mr. Mueller, Kenneth E. Bennert, Chief Financial Officer of Eclipse, Mr. Hill, and Mr. Powers, along with their respective legal counsel and independent accountants, held discussions regarding the terms and structure of the proposed business combination. On September 20, 1998, Eclipse and CardioGenesis executed mutual confidential non-disclosure agreements providing for the exchange of non-public proprietary information by the two companies for the purpose of evaluating a possible business combination. Thereafter, Eclipse and CardioGenesis, and their respective legal counsel and independent accountants, conducted extensive due diligence reviews of, among other things, each other's business, assets, financial condition, results of operations, legal affairs and prospects. On October 5, 1998, Eclipse retained PaineWebber to render a fairness opinion with respect to the proposed business combination with CardioGenesis and CardioGenesis retained Bear Stearns to act as its financial advisor in connection with the proposed business combination. On October 12, 1998, the CardioGenesis Board held a special meeting at which the management of CardioGenesis, and its legal counsel, financial advisor and independent accountants, reviewed the status of their due diligence reviews of Eclipse, the potential benefits and risks associated with a business combination with Eclipse, including the likelihood of consummating the transaction, and the proposed terms of the reorganization agreement. After an extensive discussion, the Board approved the retention of Bear Stearns and authorized senior management and the company's legal counsel and financial advisor to continue negotiations with Eclipse. At a special meeting held on October 16, 1998, the Eclipse Board discussed the potential benefits and risks associated with a business combination of Eclipse and CardioGenesis. Representatives from Wilson Sonsini Goodrich & Rosati, P.C., (WSGR) legal counsel to Eclipse, were also present at the meeting and reviewed the terms of the proposed transaction with the Board and reported to the Board on their ongoing due diligence review 39
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of CardioGenesis. WSGR also reviewed with the Board their fiduciary duties under California law. PaineWebber also attended the special meeting by telephone conference call. At the meeting, the Eclipse Board authorized management to continue negotiations with CardioGenesis and directed management to work with legal counsel and the independent accountants to continue their due diligence review. On October 18, 1998, the Eclipse Board met with representatives of WSGR and PaineWebber to further consider the potential business combination with CardioGenesis. At this meeting, Eclipse senior management, WSGR and PaineWebber reported on the ongoing discussions with CardioGenesis, the further results of the due diligence evaluation of CardioGenesis and the principal terms of the reorganization agreement and related documents. WSGR also reviewed with the Board their fiduciary duties under California law. PaineWebber reviewed with the Eclipse Board its preliminary analysis as to the fairness of the proposed exchange ratio for the transaction. The PaineWebber analysis was based on the methodology used by PaineWebber to reach its fairness opinion which was delivered in final form on October 21, 1998. At the end of the meeting, the Eclipse Board authorized management to continue negotiations with CardioGenesis and directed management to work with legal counsel and the independent accountants to complete their due diligence review. During October 1998, Dr. Murphy-Chutorian, Messrs. Mueller and Bennert and Messrs. Hill and Powers, along with their respective legal counsel and independent accountants, continued to discuss the terms and structure of the proposed business combination. During this time, Eclipse and CardioGenesis and their respective legal counsel and independent accountants continued their due diligence reviews of the other company. On October 21, 1998, the CardioGenesis Board held a special meeting to discuss with senior management and its legal counsel, financial advisor and independent accountants, the proposed terms of the business combination and the status of the due diligence reviews on Eclipse. Legal counsel reported on its ongoing review of Eclipse's legal affairs, and members of senior management and the company's accountants and financial advisor reported on the results of the business, financial and FDA due diligence with respect to Eclipse. Bear Stearns then presented, and the directors reviewed and discussed, certain financial analyses with respect to CardioGenesis, Eclipse and the proposed business combination as described under "-- Bear Stearns Opinion" on page 48; and counsel reviewed the changes negotiated in the form of reorganization agreement. The Board agreed to adjourn the meeting and reconvene later in the day to consider the final terms of the business combination and further consider the matters presented and discussed. At the reconvened meeting, the CardioGenesis Board discussed the final changes to the reorganization agreement and related documents, and received updated reports from its senior management, legal counsel and financial advisor. Bear Stearns then delivered to the Board its opinion that the exchange ratio was fair, from a financial point of view, to CardioGenesis stockholders. After further discussion, the CardioGenesis Board: - determined that the terms of the reorganization agreement and transactions contemplated thereby were fair to, and in the best interests of, CardioGenesis stockholders, - approved the reorganization agreement and related documents, and the merger, and 40
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- resolved to recommend that the CardioGenesis stockholders vote in favor of the approval and adoption of the reorganization agreement and approval of the merger at a special meeting of the CardioGenesis stockholders to be held for such purpose. On October 21, 1998, the Eclipse Board held a special meeting by telephone conference call to discuss with senior management, WSGR and PaineWebber the proposed terms of the reorganization agreement and the status of the ongoing negotiations with CardioGenesis regarding such agreement and related documents. Prior to the meeting, the directors had been provided with the current version of the reorganization agreement and related documents. The Board also received an update on the additional due diligence that had been conducted. The Eclipse Board discussed in detail the terms of the proposed transaction and agreed to hold another meeting later in the day to consider the final terms of the transaction. Later on October 21, 1998, the Eclipse Board held another special meeting by telephone conference call to consider the proposed final terms of the reorganization agreement, the merger and related documents. Representatives from WSGR and PaineWebber also participated in the meeting. The directors discussed with WSGR the proposed final changes to the reorganization agreement and related documents. At this meeting, PaineWebber provided the Eclipse Board with its oral and written opinion that the exchange ratio was fair, from a financial point of view, to Eclipse. Upon further discussion among the directors, the Eclipse Board unanimously: - determined that the terms of the reorganization agreement and the transactions contemplated thereby were fair to, and in the best interests of Eclipse shareholders; - approved the reorganization agreement, the merger and all related agreements and - resolved to recommend that the Eclipse shareholders vote in favor of the reorganization agreement including the issuance of Eclipse common stock in connection with the merger at a special meeting of the Eclipse shareholders to be held for such purpose. Later on October 21, 1998, following the Eclipse Board meeting and the CardioGenesis Board meeting, the reorganization agreement was executed by both companies and the related documents were executed by certain officers and directors of Eclipse and CardioGenesis. On October 22, 1998, prior to the beginning of trading, Eclipse and CardioGenesis issued a joint press release announcing the proposed business combination. PAINEWEBBER OPINION THE FULL TEXT OF THE PAINEWEBBER OPINION, DATED OCTOBER 21, 1998, WHICH SETS FORTH THE ASSUMPTIONS MADE, PROCEDURES FOLLOWED, MATTERS CONSIDERED AND LIMITATIONS ON THE REVIEW UNDERTAKEN, IS ATTACHED AS APPENDIX B TO THIS DOCUMENT. YOU SHOULD READ THE PAINEWEBBER OPINION CAREFULLY AND IN ITS ENTIRETY. THE SUMMARY OF THE PAINEWEBBER OPINION INCLUDED IN THIS DOCUMENT IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO THE FULL TEXT OF THE PAINEWEBBER OPINION. Eclipse retained PaineWebber to render an opinion as to whether or not the CardioGenesis/Eclipse exchange ratio was fair, from a financial point of view, to Eclipse. In connection with the consideration by the Eclipse board of directors of the reorganization agreement, PaineWebber delivered its written opinion, dated October 21, 1998, to the 41
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effect that, as of that date, and based upon its review and assumptions and subject to the limitations summarized below, the exchange ratio is fair, from a financial point of view, to Eclipse. The PaineWebber opinion was directed to, and prepared at the request and for the information of, the Eclipse board of directors and does not constitute a recommendation to any holder of Eclipse common stock as to how any such shareholder should vote with respect to the merger. The methodology used by PaineWebber to reach the fairness opinion formed the basis for the PaineWebber presentation to the Eclipse Board on October 18, 1998. In arriving at its opinion, PaineWebber, among other things: - reviewed, among other public information, CardioGenesis' annual reports, forms 10-K and related financial information for the two fiscal years ended December 31, 1997 and CardioGenesis' form 10-Q and the related unaudited financial information for the six months ended June 30, 1998; - reviewed, among other public information, Eclipse's annual reports, forms 10-K and related financial information for the two fiscal years ended December 31, 1997 and Eclipse's form 10-Q and the related unaudited financial information for the six months ended June 30, 1998; - reviewed certain information, including financial forecasts, relating to the business, earnings, cash flow, assets and prospects of CardioGenesis and Eclipse, furnished to PaineWebber by or on behalf of CardioGenesis and Eclipse; - reviewed certain information, including financial forecasts, relating to the business, earnings, cash flow, assets and prospects of the pro forma combined entities, furnished by Eclipse; - conducted discussions with members of senior management of CardioGenesis and Eclipse concerning their respective businesses and prospects; - reviewed the historical market prices and trading activity for CardioGenesis common stock and Eclipse common stock and compared them with those of certain other publicly traded companies which PaineWebber deemed to be relevant; - compared the financial position and results of operations of CardioGenesis and Eclipse with those of certain companies which PaineWebber deemed to be relevant; - compared the proposed financial terms of the merger with the financial terms of certain other mergers and acquisitions which PaineWebber deemed to be relevant; - reviewed a draft of the reorganization agreement; and - reviewed such other financial studies and analyses and performed such other investigations and took into account such other matters as PaineWebber deemed necessary, including PaineWebber's assessment of regulatory, general economic, market and monetary conditions. In preparing the PaineWebber opinion: - PaineWebber relied upon the accuracy and completeness of all information supplied or otherwise made available to it by Eclipse and CardioGenesis. - PaineWebber did not assume any responsibility to independently verify such information. With respect to the financial forecasts examined by PaineWebber, 42
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PaineWebber assumed that they were reasonably prepared and reflect the best currently available estimates and good faith judgments of the management of Eclipse and CardioGenesis as to the future performance of the Eclipse and CardioGenesis. - PaineWebber also relied upon assurances of the management of Eclipse and CardioGenesis that they are unaware of any facts that would make the information or financial forecasts provided to PaineWebber incomplete or misleading. - PaineWebber did not make any independent evaluation or appraisal of the assets or liabilities (contingent or otherwise) of Eclipse or CardioGenesis nor was PaineWebber furnished with any such evaluations or appraisals. PaineWebber has also assumed the following with Eclipse's consent: - The merger will be a tax-free reorganization. - The merger will be accounted for under the pooling-of-interests accounting treatment. - Any material liabilities (contingent or otherwise, known or unknown) of Eclipse and CardioGenesis were as set forth in the consolidated financial statements of Eclipse and CardioGenesis. No opinion was expressed in the PaineWebber opinion as to the price at which the securities of Eclipse may trade at any time. The PaineWebber opinion was based on economic, monetary and market conditions existing on the date of the opinion. The following paragraphs summarize the material analyses performed by PaineWebber in arriving at the PaineWebber opinion. Stock trading history. PaineWebber reviewed trading prices for the shares of CardioGenesis common stock. This stock trading history review indicated that for CardioGenesis' latest twelve months ended October 19, 1998, the low and high closing prices were $1.75 and $9.50. PaineWebber also reviewed CardioGenesis stock price averages over periods prior to October 19, 1998 as set forth in the following table. · Download Table TRADING PERIOD AVERAGE PRICE -------------- ------------- Latest 30 days............................ $2.41 Latest 60 days............................ $2.71 Latest 90 days............................ $3.36 Latest 120 days........................... $3.81 PaineWebber also reviewed trading prices for the shares of Eclipse common stock. This stock trading history review indicated that for Eclipse's last twelve months ended October 19, 1998, the low and high closing prices were $5.50 and $13.50. PaineWebber also reviewed Eclipse stock price averages over periods prior to October 19, 1998 as set forth in the following table. · Download Table TRADING PERIOD AVERAGE PRICE -------------- ------------- Latest 30 days............................ $ 8.88 Latest 60 days............................ $ 7.75 Latest 90 days............................ $ 9.88 Latest 120 days........................... $10.56 43
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Exchange ratio analysis. PaineWebber calculated exchange ratios based on the trading price relationship between CardioGenesis common stock and Eclipse common stock from May 30, 1996 to October 19, 1998. This exchange ratio review indicated that the low and high implied CardioGenesis/Eclipse exchange ratio were 0.2238x and 2.6000x. PaineWebber also reviewed the CardioGenesis/Eclipse exchange ratio on the dates set forth in the following table. · Download Table DATE EXCHANGE RATIO ---- -------------- October 19, 1998......................... 0.3333x 30 days prior............................ 0.2676x 60 days prior............................ 0.4355x 90 days prior............................ 0.5506x 120 days prior........................... 0.4734x One year prior........................... 1.1429x Selected comparable public company analysis. Using publicly available information, PaineWebber compared selected historical and projected financial, operating and stock market performance data of CardioGenesis and Eclipse to the corresponding data of the comparable companies. The comparable companies consisted of: · Download Table CardioGenesis Cambridge Heart, Inc. Eclipse Endosonics Corporation PLC Systems Inc. Heartport, Inc. Arthrocare Corporation Perclose, Inc. ATS Medical, Inc. Thoratec Laboratories Corporation PaineWebber reviewed, among other information, the comparable companies' multiples of total enterprise value (market value plus total debt less cash and cash equivalents as of June 30, 1998) to (1) projected calendar year 1999 revenue and (2) projected calendar year 2000 revenue. PaineWebber also reviewed, among other information, the comparable companies' multiples of market value to (1) projected calendar year 1999 earnings per share (EPS) and (2) projected calendar year 2000 EPS. All projected calendar year 1999 and 2000 estimates were based on publicly available research estimates for the comparable companies and on the projections for CardioGenesis and Eclipse as provided by Eclipse management. The comparable companies analysis resulted in the following range of values as of October 19, 1998: · Download Table ANALYSIS MULTIPLE RANGE -------- -------------- Projected calendar year 1999 revenue.... 1.01x to 4.60x Projected calendar year 2000 revenue.... 0.18x to 3.33x Projected calendar year 1999 EPS........ 9.1x to 87.5x Projected calendar year 2000 EPS........ 4.4x to 18.9x When Eclipse and CardioGenesis were excluded from the comparable companies the same multiple ranges resulted as above, except the projected calendar year 1999 EPS ranged from 12.7x to 87.5x and the projected calendar year 2000 EPS ranged from 12.6x to 18.9x. PaineWebber applied the comparable companies' median multiples to CardioGenesis' projected calendar year 1999 and 2000 revenue and EPS, as provided by Eclipse management, and derived a range of fully diluted equity values for CardioGenesis of $8.51 to $23.12 per CardioGenesis share. Based on a closing stock price of $8.25 for Eclipse 44
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common stock as of October 19, 1998, such derived equity value range for CardioGenesis implied an exchange ratio range of 1.0314x to 2.8027x. Discounted cash flow analysis. PaineWebber analyzed CardioGenesis based on an unleveraged discounted cash flow analysis of CardioGenesis projections, as provided by Eclipse management. The discounted cash flow analysis determined the discounted present value of the unleveraged after-tax cash flows generated over the time period included in the projections and then added a terminal value based upon a range of revenue multiples from 1.00x to 1.75x and earnings before interest and taxes (EBIT) multiples from 8.0x to 11.0x. The unleveraged after-tax cash flows and terminal value were discounted using a range of discount rates from 15.0% to 22.5%. Based on this analysis, PaineWebber derived a range of possible CardioGenesis fully diluted equity values of $10.66 to $23.58 per share. Based on the closing stock price of $8.25 for Eclipse Common Stock on October 19, 1998, this range of equity values implied an exchange ratio range of 1.2924x to 2.8581x. PaineWebber also analyzed Eclipse based on an unleveraged discounted cash flow analysis of Eclipse projections, as provided by Eclipse management. The discounted cash flow analysis was performed using the same methodology, range of terminal value multiples and range of discount rates as were utilized in the analysis of CardioGenesis above. Based on this analysis, PaineWebber derived a range of possible Eclipse fully diluted equity values of $6.41 to $9.59 per share. Premiums paid analysis. PaineWebber reviewed purchase price per share premiums paid in 153 publicly-disclosed cash and stock merger transactions announced since January 1, 1998 with market values between $30.0 million and $200.0 million. PaineWebber also reviewed purchase price per share premiums paid in 21 publicly-disclosed cash and stock merger transactions of companies affiliated with the life sciences sector announced since January 1, 1997 with market values between $30.0 million and $200.0 million. This analysis indicated mean premiums to the target's closing stock price as indicated in the following table: · Download Table DATE PRIOR TO MEAN OF MEAN OF LIFE SCIENCES ANNOUNCEMENT ALL TRANSACTIONS TRANSACTIONS ------------- ---------------- --------------------- One Day 27.6% 21.4% One Week 34.4 29.3 Four Weeks 37.0 41.0 Based on the closing prices of CardioGenesis' common stock one day, one week and four weeks prior to its closing stock price of October 19, 1998, applying the mean premiums to the applicable stock prices yielded fully diluted equity values of $2.91 to $3.83 per share. Based on the closing stock price of $8.25 for Eclipse common stock on October 19, 1998, this range of equity values implied an exchange ratio range of 0.3526x to 0.4642x. Selected comparable mergers and acquisitions analysis. PaineWebber reviewed publicly available financial information for selected mergers and acquisitions involving companies that are affiliated with the life sciences sector. The selected mergers and acquisitions PaineWebber analyzed included (acquiror/target): - Medtronic, Inc./Instent Inc. - St. Jude Medical Inc./Ventritex, Inc. - Endosonics Corporation/Cardiometrics, Inc. 45
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- Johnson & Johnson/Biopsys Medical, Inc. - Guidant Corporation/EndoVascular Tech. - Hewlett-Packard Company/Heartstream Inc. - Medtronic, Inc./Physio-Control International Corporation - Medtronic, Inc./AVECOR Cardiovascular Inc. - Guidant Corporation/InControl Inc. PaineWebber reviewed the consideration paid (based on stock prices on the day prior to the announcement of the transaction) in the comparable transactions and calculated the multiples of total enterprise value to the following: - the target's last twelve months (prior to the announcement of the transaction) revenue; - the target's projected one-year forward revenue; - the target's projected two-year forward revenue; - the target's projected one-year forward EBIT; - the target's projected two-year forward EBIT PaineWebber also calculated multiples of market value to (1) projected one-year forward EPS and (2) projected two-year forward EPS. All projected one-year and two-year forward results were based on publicly available research estimates prior to the announcement of the transaction. PaineWebber also reviewed multiples of the consideration paid to the target's book value. The comparable transactions analysis resulted in the following range of values: · Download Table ANALYSIS MULTIPLE RANGE -------- --------------- Last twelve months revenue..................... 2.02x to 79.72x Projected one-year forward revenue............. 1.91x to 18.43x Projected two-year forward revenue............. 1.78x to 7.37x Projected one-year forward EBIT................ 20.4x to 90.9x Projected two-year forward EBIT................ 16.6x to 25.0x Projected one-year forward EPS................. 26.4x to 98.4x Projected two-year forward EPS................. 8.3x to 37.2x Book value..................................... 2.7x to 43.4x Contribution analysis. PaineWebber analyzed Eclipse's and CardioGensis' relative contribution to the combined entity with respect to projected revenue, EBIT and pre-tax income based on projections provided by Eclipse management including synergies. Based on the exchange ratio, holders of CardioGenesis common stock will own approximately 35.2% of 46
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the common stock outstanding of the combined company after giving effect to the merger. CardioGenesis is estimated to contribute to the combined entity as follows: · Download Table ANALYSIS CONTRIBUTION -------- ------------ Projected 1999 revenue.............................. 32.0% Projected 2000 revenue.............................. 45.9% Projected 1999 EBIT................................. 41.6% Projected 2000 EBIT................................. 55.6% Projected 1999 pre-tax income....................... 41.4% Projected 2000 pre-tax income....................... 53.1% The results of this contribution analysis are not necessarily indicative of the contributions that the respective businesses may have in the future. Pro forma merger analysis. PaineWebber performed an analysis of the potential pro forma effect of the merger on Eclipse's projected EPS for the fiscal years 1999 through 2003. In performing this analysis, PaineWebber assumed, with Eclipse's consent, (1) the merger would be accounted for under the pooling-of-interests method of accounting; and (2) synergies may be achieved as a result of the merger. PaineWebber combined the projected operating results of Eclipse (provided by Eclipse management) with the projected operating results of CardioGenesis (provided by Eclipse management) to arrive at the combined company projected net income. PaineWebber divided this by the pro forma fully diluted shares outstanding to arrive at a combined company fully diluted EPS. PaineWebber then compared the combined company projected EPS to Eclipse's projected EPS based on the projections to determine the pro forma impact on Eclipse's projected EPS. The preparation of a fairness opinion involves various determinations as to the most appropriate and relevant quantitative methods of financial analyses and the application of those methods to the particular circumstances and, therefore, such an opinion is not readily susceptible to partial analysis or summary description. Accordingly, PaineWebber believes that its analysis must be considered as a whole and that considering any portion of such analysis and of the factors considered, without considering all analyses and factors, could create a misleading or incomplete view of the process underlying the PaineWebber opinion. In its analyses, PaineWebber made numerous assumptions with respect to industry performance, general business and economic conditions and other matters, many of which are beyond the control of Eclipse and CardioGenesis. Any estimates contained in these analyses are not necessarily indicative of actual values or predictive of future results or values, which may be significantly more or less favorable than as set forth therein. In addition, analyses relating to the value of businesses do not purport to be appraisals or to reflect the prices at which businesses may actually be sold. Accordingly, such analyses and estimates are inherently subject to substantial uncertainty. Due to the substantial uncertainty inherent in and the subjective nature of the assumptions underlying its analyses and estimates, PaineWebber's opinion is necessarily qualified by the accuracy of these assumptions. PaineWebber cannot and does not guarantee the accuracy of these assumptions. Eclipse selected PaineWebber to render a fairness opinion in connection with the merger because PaineWebber is a prominent investment banking and financial advisory firm with experience in the valuation of businesses and their securities in connection with mergers and acquisitions, negotiated underwritings, secondary distributions of securities, private placements and valuations for corporate purposes. 47
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Pursuant to an engagement letter between Eclipse and PaineWebber dated October 5, 1998, PaineWebber earned a fee of $500,000 for rendering the opinion. In addition, PaineWebber will be reimbursed for certain of its related expenses. Eclipse also agreed, under separate agreement, to indemnify PaineWebber, its affiliates and each of its directors, officers, agents and employees and each person, if any, controlling PaineWebber or any of its affiliates against certain liabilities, including liabilities under federal securities laws. In the past, PaineWebber and its affiliates, have provided investment banking services to Eclipse and have received customary fees for rendering these services. In the ordinary course of PaineWebber's business, PaineWebber may actively trade the securities of Eclipse and CardioGenesis for its own account and for the accounts of its customers and, accordingly, may at any time hold long or short positions in such securities. BEAR STEARNS OPINION CardioGenesis retained Bear Stearns to act as its financial advisor in connection with the merger. In connection with such engagement, CardioGenesis requested that Bear Stearns render its opinion as to the fairness, from a financial point of view, of the exchange ratio to the public stockholders of CardioGenesis. On October 21, 1998, in connection with the evaluation of the merger by the CardioGenesis Board, Bear Stearns rendered its oral opinion that, as of such date, and subject to certain assumptions, factors and limitations described below, the exchange ratio was fair, from a financial point of view, to the public stockholders of CardioGenesis. Bear Stearns also delivered a written opinion to the CardioGenesis Board, that, as of October 21, 1998, the exchange ratio was fair, from a financial point of view, to the public stockholders of CardioGenesis. THE FULL TEXT OF THE BEAR STEARNS FAIRNESS OPINION, WHICH SETS FORTH THE PROCEDURES FOLLOWED, ASSUMPTIONS MADE, MATTERS CONSIDERED AND LIMITATIONS ON THE REVIEW UNDERTAKEN IN CONNECTION WITH SUCH OPINION, IS ATTACHED AS APPENDIX C TO THIS JOINT PROXY STATEMENT/ PROSPECTUS. STOCKHOLDERS ARE URGED TO READ THE BEAR STEARNS OPINION IN ITS ENTIRETY. THE BEAR STEARNS OPINION ADDRESSES ONLY THE EXCHANGE RATIO UNDER THE REORGANIZATION AGREEMENT AND DOES NOT CONSTITUTE A RECOMMENDATION TO ANY CARDIOGENESIS STOCKHOLDER AS TO HOW SUCH STOCKHOLDER SHOULD VOTE AT THE CARDIOGENESIS SPECIAL MEETING. THE DESCRIPTION OF THE BEAR STEARNS OPINION SET FORTH IN THIS JOINT PROXY STATEMENT/PROSPECTUS IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO THE FULL TEXT OF SUCH OPINION. In arriving at its opinion, Bear Stearns: - reviewed the reorganization agreement dated October 21, 1998; - reviewed CardioGenesis' and Eclipse's Annual Reports to Stockholders and Annual Reports on Form 10-K for the fiscal years ended December 31, 1996 and December 31, 1997, and Quarterly Reports on Form 10-Q for the periods ended March 31, 1998 and June 30, 1998; - reviewed certain operating and financial information, including projections, provided to it by management relating to CardioGenesis' and Eclipse's business and prospects; - met with certain members of CardioGenesis' and Eclipse's senior management to discuss each company's operations, historical financial statements and future 48
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prospects, including, without limitation, the timing and extent of regulatory approvals and successful commercial introductions of certain products; - reviewed the historical market prices and trading volumes of the common shares of CardioGenesis and Eclipse; - reviewed publicly available financial data, stock market performance data and valuation parameters of companies which Bear Stearns deemed generally comparable to CardioGenesis and Eclipse; - reviewed the terms of recent mergers and acquisitions of companies which Bear Stearns deemed generally comparable to CardioGenesis and the merger; - considered the pro forma effects of the merger on Eclipse's revenues, operating income, and earnings, including pre-tax amounts of synergies expected by CardioGenesis and Eclipse following the merger; and - conducted such other studies, analyses, inquiries and investigations as Bear Stearns deemed appropriate. In conducting its analysis, Bear Stearns relied upon and assumed, without independent verification, the following: - the accuracy and completeness of the financial and other projections provided by CardioGenesis' and Eclipse's senior managements; - the best currently available estimates and judgements of the senior managements of CardioGenesis and Eclipse with respect to potential synergies which could be achieved upon completion of the merger; - the assumptions made by the senior managements of CardioGenesis and Eclipse regarding the timing and extent of regulatory approvals and reimbursement and successful introductions of certain products and that the receipt and timing of regulatory approvals and reimbursement and successful commercial introductions have a material impact on the projected financial results of the respective companies and potential synergies; - the assurances of the senior managements of CardioGenesis and Eclipse that they were unaware of any facts that would make the information or projections provided incomplete or misleading; and - the merger will qualify as a tax-free "reorganization" within the meaning of Section 368(a) of the Internal Revenue Code and that the merger will qualify as a pooling of interests under GAAP. In arriving at its opinion, Bear Stearns did not perform or obtain any independent appraisals of the assets or liabilities of CardioGenesis or Eclipse, nor were they furnished with any such appraisals. The Bear Stearns opinion was necessarily based on economic, market and other conditions, and the information made available to Bear Stearns, as of the date of the Bear Stearns opinion. Bear Stearns did not express any opinion as to the price or range of prices at which shares of common stock of Eclipse may trade prior to or subsequent to the consummation of the merger. 49
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In connection with preparing and rendering its opinion, Bear Stearns performed a variety of valuation, financial and comparative analyses. The summary of such analyses, as set forth below, does not purport to be a complete description of the analyses underlying the Bear Stearns opinion. The preparation of a fairness opinion is a complex process and is not necessarily susceptible to summary description. Bear Stearns believes that its analyses must be considered as a whole, and that selecting portions of its analyses and the factors considered by it without considering all such factors and analyses, could create an incomplete view of the processes underlying the Bear Stearns opinion. Moreover, the estimates contained in such analyses are not necessarily indicative of actual values or predictive of future results or values, which may be significantly more or less favorable than those suggested by such analyses. In addition, analyses relating to the value of businesses or securities do not purport to be appraisals or necessarily reflect the prices at which businesses or securities may actually be sold. Accordingly, such estimates are inherently subject to substantial uncertainties. The following is a summary of the material valuation, financial and comparative analyses presented by Bear Stearns to the CardioGenesis Board of Directors on October 21, 1998 in connection with its opinion as of such date. Historical Stock Performance. Bear Stearns reviewed the performance of the per share stock market price and equity value of CardioGenesis common stock and Eclipse common stock for selected time periods since the initial public offering of each company. Time periods selected were; at the initial public offering, first close after the initial public offering, average from initial public offering to October 21, 1998, trailing 2-year, 12-month, 6-month, 3-month, and 30-day averages and closing price as of October 21, 1998. The share prices and equity values on the selected dates were as follows: · Enlarge/Download Table CARDIOGENESIS ECLIPSE SURGICAL -------------------------- -------------------------- SHARE PRICE EQUITY VALUE SHARE PRICE EQUITY VALUE ----------- ------------ ----------- ------------ At IPO............................ $20.00 $238.5 $16.00 $250.9 First close after IPO............. 20.50 244.5 16.50 258.8 IPO -- October 21, 1998........... 9.75 119.1 8.91 154.1 Trailing 2-year average........... 9.14 111.6 8.42 145.6 Trailing 12-months average........ 6.08 74.2 8.88 153.5 Trailing 6-months average......... 4.50 55.0 9.23 159.6 Trailing 3-months average......... 3.29 40.2 7.63 131.9 Trailing 30-days average.......... 2.41 29.5 8.04 139.0 Closing price -- October 21, 1998............................ 2.22 27.1 8.78 151.9 In addition, Bear Stearns reviewed the trading levels of the common stock of each company at different market prices from the initial public offering to October 21, 1998. Bear Stearns also reviewed the implied value per share to be received by CardioGenesis stockholders based on the exchange ratio. Bear Stearns determined that based on (i) the October 21, 1998 closing price of $2.22 per share of CardioGenesis common stock and (ii) the October 21, 1998 closing price of $8.78 per share of Eclipse common stock, the merger implied a value per share of $7.03 for CardioGenesis common stock, which represented a premium of 216.6% over the October 21, 1998 closing price. Pro Forma Merger Analysis. Bear Stearns prepared pro forma analyses of the financial impact of the merger. Using the actual financial results for the fiscal year ended 50
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December 31, 1997, the latest twelve months ended June 30, 1998, the latest quarter annualized, and projected financial results provided by their respective managements for the fiscal years ending December 31, 1998 through December 31, 2002, for both CardioGenesis and Eclipse, Bear Stearns compared the results of the respective companies on a stand-alone basis with the results of the companies combined on a pro forma basis to give effect to the merger. These comparisons were based on the following assumptions: (a) an exchange ratio of 0.80 and (b) the merger being accounted for as a pooling of interests. The analysis indicated that the proposed transaction would be accretive to CardioGenesis stockholders in the years 1998-2001 and dilutive to earnings in 2002. From the pro forma analyses, Bear Stearns performed the Relative Contribution Analysis and Has/Gets Analysis outlined below. Relative Contribution Analysis. Bear Stearns calculated the relative contribution by each of CardioGenesis and Eclipse to the combined company (assuming no synergies) with respect to revenue, EBIT and net income. In 1998 to 2000, CardioGenesis, on a stand-alone basis expects to be operating at a loss and thus a relative contribution analysis is not meaningful. CardioGenesis' relative contribution to the combined company in the years 1998 - 2002 is as follows: · Download Table CARDIOGENESIS RELATIVE CONTRIBUTION ------------------------------------ 1998 1999 2000 2001 2002 ---- ---- ---- ---- ---- Revenue..................................... 34% 21% 37% 42% 44% EBIT........................................ NM NM NM 27 49 Net Income.................................. NM NM NM 27 48 By way of comparison, Bear Stearns observed that the exchange ratio would result in holders of CardioGenesis common stock receiving a 36% ownership position in the newly combined company. Has/Gets Analysis. Bear Stearns also conducted a has/gets analysis for 1998-2002 estimated revenues, EBIT and earnings per share. Giving effect to the exchange ratio, the has/gets analysis, assuming synergies, implies the merger would be accretive to CardioGenesis stockholders in 1998, 1999, 2000 and 2001, and dilutive to CardioGenesis stockholders in 2002. In performing such analyses Bear Stearns did not take into account any future equity financings by either company which may be required to fund future operations. Pro forma for the merger, the effect on earnings per share to CardioGenesis stockholders is as follows: · Download Table CARDIOGENESIS EARNINGS PER SHARE ACCRETION/(DILUTION), ASSUMING SYNERGIES ------------------------------------------ 1998 1999 2000 2001 2002 ------ ------ ------ ------ ------ CardioGenesis earnings per share...... $(2.04) $(1.54) $(0.31) $ 0.55 $ 1.45 Earnings per share after the merger... (1.26) 0.09 0.53 0.84 1.22 Earnings per share accretion/(dilution)................ 0.77 1.63 0.84 0.29 (0.23) Comparable Company Analysis. Bear Stearns compared certain operating, financial, trading and valuation information for CardioGenesis and Eclipse to certain publicly available operating, financial, trading and valuation information of seven selected small capitalization medical device companies, which, in Bear Stearns' judgement, were the most 51
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comparable to CardioGenesis and Eclipse for the purposes of this analysis. These companies included: - CardioThoracic Systems Inc., - Computer Motion, Inc., - EndoSonics Corporation, - Heartport, Inc., - Novoste Corporation, - Perclose Inc., and - PLC Systems Inc. Bear Stearns' analysis was based on the closing prices on October 21, 1998. For comparative purposes, Bear Stearns calculated the implied price per share and related valuation multiples for CardioGenesis based on the October 21, 1998 Eclipse closing stock price of $8.78, which implied a per share price of $7.03 for CardioGenesis. The comparable companies analysis resulted in the following set of valuation multiples relative to the merger: · Download Table SELECTED COMPARABLE COMPANIES ---------------------- MERGER LOW HIGH MEAN ------ ---- ----- ----- Price/2000 estimated earnings per share.......... 12.8x 9.2x 42.1x 14.6x Price/2001 estimated earnings per share.......... 4.8 3.3 17.1 5.9 Bear Stearns noted in its analysis that all of the comparable companies selected were small capitalization, early-stage medical device companies operating at a loss, as are CardioGenesis and Eclipse, and thus the derivation of meaningful valuation parameters was limited. Precedent Transaction Analysis. Bear Stearns reviewed and analyzed the publicly available financial terms of five selected precedent merger and acquisition transactions. In Bear Stearns' judgement these were the most comparable recent transactions involving small capitalization target companies in the medical device industry. These five transactions included: - Johnson & Johnson's pending acquisition of FemRx, - Hewlett Packard's acquisition of Heartstream, - Johnson & Johnson's acquisition of Gynecare, - Urohealth Systems' acquisition of Imagyn Medical, and - EndoSonics' acquisition of Cardiometrics. Bear Stearns reviewed the prices paid in the precedent transactions and analyzed various operating and financial information and imputed premiums paid, valuation multiples and ratios. For comparative purposes, Bear Stearns calculated the Enterprise Value / latest twelve months revenue multiple, premium paid over the prior day's closing stock price, and premium paid over the average closing price for four weeks prior for CardioGenesis based on the 0.80 exchange ratio. Bear Stearns noted that all of the target companies used in the 52
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analysis were small capitalization, early-stage medical device companies operating at a loss, as are CardioGenesis and Eclipse, and thus the derivation of meaningful valuation parameters was limited. The precedent transaction analysis resulted in the following set of valuation multiples relative to the merger: · Download Table SELECTED PRECEDENT TRANSACTIONS ----------------------- MERGER LOW HIGH MEAN ------ ----- ----- ----- Enterprise Value / latest twelve months revenue....................................... 11.7x 1.8x 17.9x 7.6x Premium paid / prior day's closing stock price......................................... 217% (7.4%) 41.2% 21.2% Premium paid / average closing stock price for four weeks prior.............................. 167% (9.3%) 81.4% 46.5% Pursuant to its engagement letter, dated October 5, 1998, CardioGenesis is obligated to pay Bear Stearns an opinion fee of $350,000 and an advisory fee of $500,000. The opinion fee is to be credited against the advisory fee. CardioGenesis has also agreed to reimburse Bear Stearns for its reasonable out-of-pocket expenses, including fees and expenses of legal counsel, and to indemnify Bear Stearns and certain related persons against certain liabilities. Bear Stearns previously acted as an underwriter in connection with CardioGenesis' initial public offering on May 22, 1996. In the ordinary course of business, Bear Stearns may actively trade the equity securities of CardioGenesis for its own account and for the account of its customers and, accordingly, may at any time hold a long or short position in such securities. Bear Stearns is an internationally recognized investment banking firm and was selected as financial advisor to CardioGenesis in connection with the merger and was asked to render its opinion in connection with the merger based on Bear Stearns' qualifications, expertise and reputation in providing advice to companies in the health care industry, as well as its familiarity with CardioGenesis and Eclipse. As part of its investment banking business, Bear Stearns is regularly engaged in the valuation of businesses and their securities in connection with mergers and acquisitions, negotiated underwritings, competitive bidding, secondary distribution of listed and unlisted securities, private placements and valuation for estate, corporate and other purposes. MATERIAL FEDERAL INCOME TAX CONSEQUENCES The following discussion summarizes the material federal income tax consequences of the merger that are generally applicable to CardioGenesis stockholders exchanging their CardioGenesis common stock for Eclipse common stock. This discussion is based on U.S. federal income tax law, including the Internal Revenue Code, regulations, rulings, decisions and administrative practice, all as in effect on the date hereof. Future legislation, regulations, administrative interpretations or court decisions could change such laws either prospectively or retroactively. This discussion is also based on the opinions of legal counsel referred to below. This discussion does not deal with all income tax considerations that may be relevant to particular CardioGenesis stockholders in light of their particular circumstances, such as stockholders who are dealers in securities, who are foreign persons, who acquired their shares in connection with previous mergers involving CardioGenesis or an affiliate or who acquired their shares in connection with stock option or stock purchase plans or in other compensatory transactions. In addition, the following discussion does not address the tax consequences of transactions effectuated prior to or after the merger 53
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(whether or not such transactions are in connection with the merger), including without limitation transactions in which shares of CardioGenesis common stock were or are acquired or shares of Eclipse common stock were or are disposed of. Furthermore, no foreign, state or local tax considerations are addressed herein. Accordingly, CardioGenesis stockholders are urged to consult their own tax advisors as to the specific tax consequences of the merger, including the applicable federal, state, local and foreign tax consequences to them of the merger. Eclipse and CardioGenesis have each received an opinion from their legal counsel, WSGR and Heller Ehrman, respectively, to the effect that, for federal income tax purposes, the merger will qualify as a "reorganization" within the meaning of Section 368(a) of the Internal Revenue Code. As a reorganization, the merger will have the following federal income tax consequences (subject to the limitations and qualifications referred to herein): - no gain or loss will be recognized by CardioGenesis stockholders (except that cash received in lieu of fractional shares may cause recognition of gain or loss) upon their receipt of Eclipse common stock in the merger in exchange for CardioGenesis common stock; - cash payments in lieu of a fractional share will be treated as if such fractional share of Eclipse common stock had been issued in the merger and then redeemed by Eclipse. A CardioGenesis stockholder receiving such cash will generally recognize capital gain or loss upon such payment equal to the difference (if any) between such stockholder's basis in the fractional share and the amount of cash received; - the aggregate tax basis of the Eclipse common stock actually received in the merger by a CardioGenesis stockholder will be the same as the aggregate tax basis of the CardioGenesis common stock surrendered in exchange therefor, minus the tax basis allocated to any fractional share of Eclipse common stock treated as issued and redeemed; - the holding period of the Eclipse common stock received in the merger by a CardioGenesis stockholder will include the period during which the stockholder held the CardioGenesis common stock surrendered in exchange therefor, provided that the CardioGenesis common stock is held as a capital asset at the time of the merger; and - none of Eclipse, merger sub or CardioGenesis will recognize gain or loss solely as a result of the merger. The parties are not requesting a ruling from the IRS in connection with the merger. The tax opinions referred to above neither bind the IRS or a court nor preclude the IRS or a court from adopting a contrary position. In addition, the tax opinions are subject to certain assumptions and qualifications and are based on the truth and accuracy of certain customary representations made by Eclipse, merger sub and CardioGenesis, including customary representations in certificates to be delivered to counsel by the respective managements of Eclipse, merger sub and CardioGenesis including, for example: - representations related to the ownership and operations of merger sub and CardioGenesis; - the terms of the merger; and - the conduct of the business of CardioGenesis following the merger. 54
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A successful IRS challenge to the "reorganization" status of the merger would result in a CardioGenesis stockholder recognizing gain or loss with respect to each share of CardioGenesis common stock surrendered equal to the difference between the stockholder's basis in such share and the fair market value, as of the effective time of the merger, of the common stock of Eclipse received in exchange therefor. In such event, a stockholder's aggregate basis in the common stock of Eclipse so received would equal such fair market value and his holding period for such stock would begin the day after the merger. If either Eclipse or CardioGenesis waives the condition that requires delivery of a tax opinion from its respective legal counsel and such waiver is due to a material change in the tax consequences of the merger, Eclipse and CardioGenesis will notify their respective shareholders of such change, and if shareholder approval has already been obtained, such approval will be resolicited. GOVERNMENTAL AND REGULATORY APPROVALS The parties were not required to file notifications and furnish information to comply with requirements of the HSR Act to the Federal Trade Commission or the Department of Justice. At any time before or after consummation of the merger, the DOJ, the FTC or any state or foreign governmental authority, could take such action under the antitrust laws as it deems necessary or desirable in the public interest. Such action could include seeking to enjoin the consummation of the merger or seeking divestiture of CardioGenesis or businesses of Eclipse or CardioGenesis by Eclipse. Private parties may also seek to take legal action under the antitrust laws under certain circumstances. Based on information available to them, Eclipse and CardioGenesis believe that the merger will be effected in compliance with federal, state and foreign antitrust laws. However, there can be no assurance that a challenge to the consummation of the merger on antitrust grounds will not be made or that, if such a challenge were made, Eclipse and CardioGenesis would prevail. EXPECTED ACCOUNTING TREATMENT The merger is intended to qualify as a pooling of interests in accordance with GAAP. Consummation of the merger is conditioned upon receipt by Eclipse and CardioGenesis at the closing of the merger of letters from PricewaterhouseCoopers LLP, to the effect that, after reasonable investigation, they are not aware of any fact concerning Eclipse or CardioGenesis that could preclude pooling of interests accounting for the merger under Accounting Principles Board Opinion No. 16, if consummated according to the terms of the reorganization agreement. 55
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THE REORGANIZATION AGREEMENT AND RELATED AGREEMENTS The following is a summary of the material provisions of the reorganization agreement and other related agreements. A copy of the reorganization agreement is attached to this joint proxy statement/prospectus as Appendix A. You are encouraged to read the entire reorganization agreement. EFFECTIVE TIME; EFFECT OF MERGER The closing of the merger will take place at a time and date to be specified by the parties, which will be no later than the second business day after the satisfaction or waiver of the conditions set forth in the reorganization agreement, or at such other time, date and location as CardioGenesis and Eclipse agree in writing. At the closing, Eclipse and CardioGenesis will cause the merger to be consummated by filing a certificate of merger with the Secretary of State of the State of Delaware in accordance with Delaware law; the time of such filing (or such later time as may be agreed to in writing by CardioGenesis and Eclipse) is the "effective time." In connection with the merger, Eclipse formed a wholly-owned subsidiary, called merger sub in this joint proxy statement/prospectus, solely for the purpose of effectuating the merger. At the effective time, the separate corporate existence of merger sub will cease and CardioGenesis will continue as the surviving corporation. In addition, all of the debts, liabilities and duties of CardioGenesis and merger sub will vest in and become debts, liabilities and duties of the surviving corporation. At the effective time, the certificate of incorporation of merger sub in effect immediately prior to the effective time will become the certificate of incorporation of the surviving corporation and the bylaws of merger sub will become the bylaws of the surviving corporation. CONVERSION OF SHARES At the effective time, by virtue of the merger and without any action on the part of merger sub, CardioGenesis or the holders of any CardioGenesis or merger sub securities, each share of CardioGenesis common stock issued and outstanding immediately prior to the effective time will be canceled and converted into 0.80 of a share of Eclipse common stock. Each share of CardioGenesis common stock held by CardioGenesis, merger sub, Eclipse or any direct or indirect wholly-owned subsidiary of CardioGenesis or Eclipse immediately prior to the effective time will be canceled without any conversion thereof. Each share of common stock of merger sub issued and outstanding immediately prior to the effective time will be converted into one share of common stock of the surviving corporation. The exchange ratio will be adjusted to reflect appropriately the effect of any stock split, reverse stock split, stock dividend, reorganization, recapitalization or other like change with respect to Eclipse common stock or CardioGenesis common stock occurring on or after October 21, 1998 and prior to the effective time. None of such actions is planned by either company. No fractional shares of Eclipse common stock will be issued in the merger. Each holder of CardioGenesis common stock who would otherwise be entitled to a fraction of a share of 56
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Eclipse common stock will receive an amount of cash equal to the product of such fraction multiplied by the value of one share of Eclipse common stock. Promptly after the effective time, Eclipse will cause the exchange agent to deliver to each CardioGenesis stockholder of record as of such date a letter of transmittal and instructions for use in effecting the surrender of certificates which, prior to the merger, represented shares of CardioGenesis common stock, in exchange for shares of Eclipse common stock and cash in lieu of fractional shares. CERTIFICATES SHOULD NOT BE SURRENDERED BY THE HOLDERS OF CARDIOGENESIS COMMON STOCK UNTIL SUCH HOLDERS RECEIVE THE LETTER OF TRANSMITTAL FROM THE EXCHANGE AGENT. If you have lost your stock certificate, you will be required to deliver an affidavit of loss and may be required to post a bond. TREATMENT OF OPTIONS AND STOCK PURCHASE RIGHTS As of the record date there were options to purchase a total of 2,358,856 shares of CardioGenesis common stock outstanding. At the effective time, each outstanding CardioGenesis stock option will be assumed by Eclipse. Each CardioGenesis stock option so assumed will continue to be subject to the same terms and conditions set forth in the applicable CardioGenesis stock option plan immediately prior to the effective time, except that the number of shares and exercise price of each such CardioGenesis stock option will be appropriately adjusted for the exchange ratio. It is intended that the CardioGenesis stock options assumed by Eclipse will qualify as incentive stock options, as defined in Section 422 of the Internal Revenue Code, to the extent they qualified as incentive stock options immediately prior to the effective time. At the effective time, each right to acquire CardioGenesis common stock outstanding under the CardioGenesis stock purchase plan will be assumed by Eclipse and appropriately adjusted for the exchange ratio. STOCK OWNERSHIP IMMEDIATELY FOLLOWING THE MERGER Based upon the capitalization of CardioGenesis as of the close of business on February 8, 1999 and the exchange ratio, an aggregate of approximately 9,908,040 shares of Eclipse common stock will be issued to CardioGenesis stockholders in the merger and the former holders of CardioGenesis common stock will hold approximately 36.0% of the total number of shares of Eclipse common stock issued and outstanding immediately after the merger. At the effective time, Eclipse will also assume all CardioGenesis options outstanding and all CardioGenesis stock purchase rights for an aggregate of up to approximately 1,887,085 additional shares of Eclipse common stock. Based upon the number of shares of Eclipse common stock issued and outstanding as of February 8, 1999, and after giving effect to the issuance of Eclipse common stock in the merger as described in the previous sentence, holders of former CardioGenesis options and stock purchase rights would hold options and rights to acquire up to approximately 6.4% of Eclipse's total issued and outstanding shares immediately after the effective time of the merger (assuming the exercise of only such options and rights). The foregoing numbers of shares and percentages are subject to change in the event that the capitalization of either Eclipse or CardioGenesis changes subsequent to February 8, 1999. 57
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REPRESENTATIONS AND WARRANTIES CardioGenesis, Eclipse and merger sub have made representations and warranties in the reorganization agreement relating to, among other things: - their respective capitalization and organization and that of their respective subsidiaries; - authorization, execution, delivery and enforceability of the reorganization agreement and related matters; - documents and financial statements filed with the SEC and the accuracy of information contained in such filings; - absence of undisclosed liabilities; - taxes, tax returns and tax deficiencies; - intellectual property rights; - compliance with laws; - material litigation; - brokers' and finders' fees; - employment, environmental and labor matters; - title to properties; - agreements, contracts and commitments; - ability to account for the merger as a pooling of interests; - change of control payments; - accuracy of information provided for this joint proxy statement/prospectus; - approvals of the CardioGenesis Board and the Eclipse Board; and - opinions received from Bear Stearns and PaineWebber regarding the merger. The reorganization agreement also contains a representation by CardioGenesis relating to the non-applicability of Section 203 of the Delaware General Corporation Law. None of the representations and warranties of the parties in the reorganization agreement described above will survive the effective time. The parties to the reorganization agreement have agreed to make representations that will serve as a basis for the tax opinions to be delivered by legal counsel. CONDUCT OF ECLIPSE'S AND CARDIOGENESIS' BUSINESS PRIOR TO THE MERGER Until the earlier of the termination of the reorganization agreement or the effective time, each of CardioGenesis and Eclipse has agreed to: - carry on its business diligently in the usual, regular and ordinary course; - to pay its debts and taxes when due subject to good faith disputes; - to pay or perform other material obligations when due; and 58
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- to preserve intact its present business organization, keep available the services of its present officers and employees and preserve its relationships with customers, suppliers, distributors, licensors, licensees, and others with which it has business dealings. The reorganization agreement further provides that until the date of the merger, neither CardioGenesis nor Eclipse will do any of the following: - waive any stock repurchase rights, change the period of exercisability of options or restricted stock, reprice any options; or authorize cash payments in exchange for any options; - grant severance to any employee, except in amounts consistent with existing policies and past practices or pursuant to written agreements, or adopt any new severance plan; - transfer or license, or otherwise extend, amend or modify any rights to the CardioGenesis intellectual property rights or the Eclipse intellectual property rights, as the case may be, or enter into grants to future patent rights, other than in the ordinary course of business consistent with past practice; provided, however, that Eclipse will be permitted to undertake a transaction involving its Microheart subsidiary; - declare or pay any dividends on, or make any other distributions in respect of its capital stock, or split, combine or reclassify any capital stock, or issue or authorize the issuance of any other securities in respect of, in lieu of or in substitution for any capital stock; - repurchase any shares of capital stock, except in carrying out existing rights of repurchase under any stock plan; - issue or authorize the issuance of any shares of capital stock or any securities convertible into capital stock, or subscriptions, rights, warrants or options to acquire capital stock or any securities convertible into capital stock, other than: (a) upon the exercise of stock options; (b) the grant of options to purchase CardioGenesis common stock or Eclipse common stock, as the case may be, at fair market value in the ordinary course of business; and (c) shares of CardioGenesis common stock or Eclipse common stock, as the case may be, issuable to participants in the Eclipse 1996 Employee Stock Purchase Plan or the CardioGenesis Purchase Plan consistent with past practice and the terms thereof; - amend any charter document or bylaw; - acquire or agree to acquire any business, corporation or other business organization, or otherwise acquire or agree to acquire any assets which are material to the business of CardioGenesis or Eclipse, as the case may be, or enter into any material joint ventures, strategic partnerships or alliances; - sell, lease, license, encumber or otherwise dispose of any properties or assets which are material, individually or in the aggregate, to the business of CardioGenesis or 59
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Eclipse, as the case may be, except in the ordinary course of business consistent with past practice; - incur any indebtedness for borrowed money, other than trade payables or under existing credit facilities, or guarantee any such indebtedness or the debt of others; - adopt or amend any employee benefit plan, or enter into any employment contract, pay any special bonus or special remuneration to any director or employee, or increase the salaries or wage rates of its officers or employees other than in the ordinary course of business, consistent with past practice, or change in any material respect any management policies or procedures; - pay, discharge or satisfy any claim, liability or obligation, other than in the ordinary course of business; - make any grant of exclusive rights to any third party; - take any action that would be reasonably likely to interfere with Eclipse's ability to account for the merger as a pooling of interests; or - agree in writing or otherwise to take any of the actions described above. NO SOLICITATION Until the earlier of the date of the merger or termination of the reorganization agreement, each of Eclipse and CardioGenesis has agreed that it will not, its subsidiaries will not, and it will instruct its respective directors, officers, employees, representatives, investment bankers, agents and affiliates not to: - solicit or encourage submission of any proposal or offer by any third party; - participate in any discussions or negotiations with, or disclose any non-public information to, any third party relating to an acquisition proposal as described below; or - enter into any agreement or understanding with any third party in connection with any acquisition proposal. For purposes of the reorganization agreement, an "acquisition proposal" means any proposal or offer relating to: - any merger, consolidation, sale of substantial assets or similar transaction involving the entity or any subsidiaries of the entity; - sale of 15% or more of the outstanding shares of capital stock of the entity in a tender or exchange offer or otherwise; - the acquisition of beneficial ownership or right to acquire beneficial ownership of, or the formation of any "group" (as defined under Section 13(d) of the Exchange Act) that beneficially owns or has the right to acquire beneficial ownership of, 15% or more of the then outstanding shares of capital stock of the entity (except for acquisitions for passive investment purposes only); or - any public announcement of a proposal, plan or intention to do any of the foregoing or any agreement to engage in any of the foregoing. 60
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Each of Eclipse and CardioGenesis and their respective Boards, may take the following actions: - participate in discussions or negotiations with and/or furnish non-public information to any third party that has made an unsolicited acquisition proposal in writing; and - recommend an unsolicited acquisition proposal if the Board of the affected company determines in good faith (a) after consultation with its financial advisor, that such acquisition proposal would result in a superior proposal, as described below, and (b) following consultation with outside legal counsel, that the failure to participate in such discussions or negotiations, or to furnish such information or recommend, approve or accept such acquisition proposal would violate the Board's fiduciary duties under applicable law. For purposes of the reorganization agreement, a "superior proposal" means any acquisition proposal, made in writing and not initiated, solicited or encouraged in violation of the reorganization agreement, on terms which the Board of the affected company determines in good faith, after consultation with its financial advisor, to be more favorable to its stockholders than the merger. In addition, each of Eclipse and CardioGenesis has agreed to notify the other in the event an inquiry or acquisition proposal is made or information or access is requested, and to furnish to the other the significant terms and conditions of any acquisition proposal. Under the reorganization agreement, the CardioGenesis Board is required to recommend to its stockholders approval and adoption of the merger agreement and approval of the merger, and the Eclipse Board is required to recommend to its shareholders the issuance of the Eclipse common stock required by the reorganization agreement. The Boards may not: - withdraw or modify, or propose to withdraw or modify, in any manner adverse to the other company, its approval and recommendation of the merger agreement and the merger, or the issuance of shares, as the case may be; or - approve or recommend, or propose to approve or recommend, any acquisition proposal unless, in each case, the Board of the affected company has (a) determined that such acquisition proposal is a superior proposal, (b) determined in good faith, following consultation with outside legal counsel, that the failure to take such action would violate the Board's fiduciary duties under applicable law, and (c) provided the other company with a copy of the superior proposal 48 hours before. If either the CardioGenesis Board or the Eclipse Board determine to recommend a superior proposal to its stockholders, such Board may withdraw, modify or refrain from making a recommendation concerning the merger and discontinue soliciting proxies for the approval and adoption of the reorganization agreement and approval of the merger, or the issuance of the Eclipse common stock, as the case may be; provided, however, that such company shall remain obligated to hold and convene its special meeting. The reorganization agreement provides that Eclipse may undertake a transaction involving its MicroHeart, Inc. subsidiary and that such a transaction will not be considered an "acquisition proposal" for purposes of the reorganization agreement. 61
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BOARD AND MANAGEMENT OF THE COMBINED COMPANY FOLLOWING THE MERGER After the effective time, the Board of Directors of the combined company will consist of seven members, four from Eclipse and three from CardioGenesis. The designees from Eclipse will be Douglas Murphy-Chutorian, M.D., Robert L. Mortensen, Iain M. Watson and Alan L. Kaganov. The designees from CardioGenesis will be Allen W. Hill, Jack M. Gill and Robert C. Strauss. If, prior to the effective time, any of the Eclipse or CardioGenesis designees declines or is unable to serve, then the company designating such person will designate another person, reasonably acceptable to the other company, to serve in such person's stead. At the effective time, the Eclipse Board will elect Douglas Murphy-Chutorian, M.D., as Chairman of the Board; Allen W. Hill as Chief Executive Officer and Richard P. Powers as Executive Vice President of Finance and Administration and Chief Financial Officer and Secretary. CONDITIONS TO THE MERGER The respective obligations of each party to the reorganization agreement to effect the merger are subject to the satisfaction or waiver at or prior to the effective time of the following conditions: - Eclipse shareholders and CardioGenesis stockholders shall have approved the issuance of Eclipse common stock in the merger and the reorganization agreement and the merger, respectively; - the SEC shall have declared effective the registration statement of which this joint proxy statement/prospectus is a part, and the registration statement shall not be subject to any stop order suspending its effectiveness or to any proceedings seeking a stop order; - no governmental entity shall have taken any action which renders the merger illegal or prohibits the consummation of the merger; - Eclipse and CardioGenesis will each have received written opinions from its legal counsel to the effect that the merger will constitute a tax-free reorganization within the meaning of Section 368(a) of the Code; - the shares of Eclipse common stock issuable to CardioGenesis stockholders and such other shares required to be reserved for issuance in connection with the merger will have been authorized for listing on Nasdaq; and - each of Eclipse and CardioGenesis will have received a letter from its independent accountants to the effect that they are not aware of any fact that could preclude Eclipse from accounting for the merger as a pooling of interests in accordance with GAAP. In addition, the obligation of CardioGenesis to consummate the merger is subject to the satisfaction or waiver at or prior to the effective time of each of the following conditions: - the representations and warranties of Eclipse and merger sub contained in the reorganization agreement will be true and correct; 62
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- Eclipse and merger sub will have performed or complied in all material respects with all agreements and covenants required by the reorganization agreement to be performed or complied with by them on or prior to the effective time; and - no material adverse effect with respect to Eclipse will have occurred since the date of the reorganization agreement. Furthermore, the obligations of Eclipse and merger sub to consummate and effect the merger are subject to the satisfaction or waiver at or prior to the effective time of each of the following additional conditions: - the representations and warranties of CardioGenesis contained in the reorganization agreement will be true and correct; - CardioGenesis will have performed or complied in all material respects with all agreements and covenants required by the reorganization agreement to be performed or complied with by it on or prior to the effective time; and - no material adverse effect with respect to CardioGenesis will have occurred since the date of the reorganization agreement. TERMINATION OF THE REORGANIZATION AGREEMENT The reorganization agreement provides that it may be terminated at any time prior to the effective time: - by the mutual written consent of Eclipse and CardioGenesis; - by either Eclipse or CardioGenesis if the merger has not been consummated by April 30, 1999; provided, that this right to terminate the reorganization agreement is not available to any party that breached its obligations under the reorganization agreement in a manner that resulted in the failure of the merger to occur on or before such date; - by either Eclipse or CardioGenesis if a governmental entity takes any action, which is final and not appealable, that permanently restrains, enjoins or otherwise prohibits the merger; - by either Eclipse or CardioGenesis if the required shareholder approvals have not been obtained by reason of the failure to obtain the required vote at the CardioGenesis special meeting or the Eclipse special meeting; provided, that this right to terminate the reorganization agreement is not available to any party that breached its obligations under the reorganization agreement in a manner that caused the failure to obtain such shareholder approval; - by Eclipse, if the CardioGenesis Board recommends a superior proposal to its stockholders, or if the CardioGenesis Board withholds, withdraws or modifies in a manner adverse to Eclipse its recommendation concerning the merger; - by CardioGenesis, if the Eclipse Board recommends a superior proposal to its shareholders, or if the Eclipse Board withholds, withdraws or modifies in a manner adverse to CardioGenesis its recommendation concerning the issuance of shares of Eclipse common stock in the merger; 63
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- by CardioGenesis, upon a breach of any representation, warranty, covenant or agreement on the part of Eclipse set forth in the reorganization agreement, or if any representation or warranty of Eclipse shall have become untrue; provided, that if such inaccuracy or breach is curable prior to April 30, 1999 through the exercise of commercially reasonable efforts, then CardioGenesis may not terminate the reorganization agreement if Eclipse continues to exercise commercially reasonable efforts to cure such breach; or - by Eclipse, upon a breach of any representation, warranty, covenant or agreement on the part of CardioGenesis set forth in the reorganization agreement, or if any representation or warranty of CardioGenesis shall have become untrue; provided, that if such inaccuracy or breach is curable prior to April 30, 1999 through the exercise of commercially reasonable efforts, then Eclipse may not terminate the reorganization agreement if CardioGenesis continues to exercise such commercially reasonable efforts to cure such breach. TERMINATION FEES All fees and expenses incurred in connection with the reorganization agreement and the transactions contemplated thereby will be paid by the party incurring such expenses whether or not the merger is completed, except that Eclipse and CardioGenesis will share equally all fees and expenses, other than attorneys' and accountants' fees and expenses, incurred in connection with the printing and filing of this joint proxy statement/prospectus. Each of Eclipse and CardioGenesis has agreed that if (a) its Board withholds, withdraws or modifies, in a manner adverse to the other, its recommendation under the reorganization agreement, or (b) its Board recommends a superior proposal to its shareholders, then it will pay to the other party a $3 million termination fee within one business day of the earlier of the termination of the reorganization agreement by the other party or a negative vote at the Eclipse special meeting or at the CardioGenesis special meeting, as appropriate. The termination fee will also be payable in the event: - either of the special meetings is not held on or before April 30, 1999 or a negative vote on the reorganization agreement and the merger, or the issuance of shares, is recorded at the CardioGenesis or Eclipse special meeting; - the other party terminates the reorganization agreement in accordance with its terms; and - the party who failed to hold its special meeting or at which the negative vote was recorded either enters into a definitive agreement with respect to an acquisition proposal or consummates such a transaction, within nine months of the failed meeting date or the negative vote. Eclipse and CardioGenesis have agreed that payment of the termination fees will not be the exclusive remedy in the event of a breach of the reorganization agreement. VOTING AGREEMENTS Each of the directors and executive officers of Eclipse, who together held approximately 28% of the Eclipse common stock outstanding as of the record date, have entered into voting agreements with CardioGenesis and granted it irrevocable proxies. These share- 64
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holders, as such, have agreed to vote all of their shares of Eclipse common stock in favor of the issuance of shares of Eclipse common stock in the merger. Each of the directors and executive officers of CardioGenesis, who together held approximately 29% of the CardioGenesis common stock outstanding as of the record date, have entered into voting agreements with Eclipse and granted it irrevocable proxies. These stockholders, as such, have agreed to vote all of their shares of CardioGenesis common stock in favor of the approval and adoption of the reorganization agreement and approval of the merger. AFFILIATE AGREEMENTS Each of the directors and executive officers of Eclipse have entered into agreements restricting sales, dispositions or other transactions reducing their risk of investment in respect of the shares of Eclipse common stock held by them to help ensure that the merger will be treated as a pooling of interests for accounting purposes. Each of the directors and executive officers of CardioGenesis have similarly entered into agreements restricting sales, dispositions or other transactions reducing their risk of investment in respect of the shares of CardioGenesis common stock held by them prior to the merger and the shares of Eclipse common stock received by them in the merger so as to comply with the requirements of applicable federal securities and tax laws and to help ensure that the merger will be treated as a pooling of interests for accounting purposes. INTERESTS OF CERTAIN PERSONS Indemnification. The reorganization agreement provides that from and after the effective time, the bylaws of the surviving corporation will honor the indemnification provisions set forth in CardioGenesis' bylaws, which provisions will not be amended or repealed for a period of six years in any manner that would adversely affect the rights of individuals who were directors, officers, employees or agents of CardioGenesis, at the effective time, unless required by law. Eclipse and the surviving corporation will honor and fulfill the obligations of CardioGenesis under existing indemnification agreements between CardioGenesis and its officers and directors. The reorganization agreement also provides that for a period of six years after the effective time, Eclipse or the surviving corporation will maintain in effect, if available, directors' and officers' liability insurance covering those persons who are currently covered by CardioGenesis' insurance policy on terms comparable to those applicable to the then current directors and officers of CardioGenesis. However, in no event will Eclipse or the surviving corporation be required to pay in excess of 125% of the annual premium currently paid by CardioGenesis for such coverage. Furthermore, if the premium for such coverage exceeds that amount, Eclipse or the surviving corporation will purchase a policy with the greatest coverage available for 125% of the current annual premium. The indemnification and insurance obligations of the reorganization agreement are intended to benefit the indemnified parties and will be binding on all successors and assigns of the surviving corporation. 65
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Management. For information regarding the composition of the Board of Directors and the senior management of the combined company after the merger, see "-- Board and Management of the Combined Company Following the Merger" at page 62. NO DISSENTERS' OR APPRAISAL RIGHTS Under Delaware law, stockholders of CardioGenesis are not entitled to appraisal rights in connection with the merger. Shareholders of Eclipse are not entitled to dissenters' rights under California law in the merger. 66
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COMPARISON OF CAPITAL STOCK DESCRIPTION OF ECLIPSE CAPITAL STOCK The authorized capital stock of Eclipse consists of 50,000,000 shares of common stock, no par value per share, and 5,000,000 shares of preferred stock, no par value per share. Eclipse Common Stock. As of the record date, there were 17,621,323 shares of Eclipse common stock outstanding held of record by 178 shareholders. The holders of Eclipse common stock are entitled to one vote per share on all matters to be voted upon by the shareholders. The shareholders have the right to take any action which may be taken at any annual or special meeting by written consent without a meeting, and may cumulate votes in connection with the election of directors. The holders of Eclipse common stock are entitled to receive ratably such dividends, if any, as may be declared from time to time by the Board of Directors out of funds legally available therefor. In the event of a liquidation, dissolution or winding up of Eclipse, the holders of Eclipse common stock are entitled to share ratably in all assets remaining after payment of liabilities and any liquidation preference on the preferred stock. The Eclipse common stock has no preemptive or conversion rights or other subscription rights. There are no redemption or sinking fund provisions applicable to the Eclipse common stock. All outstanding shares of Eclipse common stock are fully paid and non-assessable, and the shares of Eclipse common stock to be outstanding upon completion of the merger will be fully paid and non-assessable. Eclipse Preferred Stock. Eclipse has 5,000,000 shares of preferred stock authorized, of which, as of the record date, no shares were outstanding. Although it presently has no intention to do so, the Eclipse Board, without shareholder approval, has the authority to designate one or more series of preferred stock and to fix the rights, preferences, privileges and restrictions thereof, including dividend rights, conversion rights, voting rights, preemptive rights, terms of redemption, liquidation preferences and sinking fund terms. The Board of Directors similarly has the authority to fix the number of shares of each such series (up to an aggregate for all series of preferred stock of 5,000,000 shares); to increase or decrease such number of shares (but not below the number of shares of any such series then outstanding) and to issue up to 5,000,000 shares. The issuance of preferred stock could adversely affect the voting power of holders of common stock and the likelihood that such holders will receive dividend payments and payments upon liquidation and could have the effect of delaying, deferring, or preventing a change in control of Eclipse. Eclipse Warrants. As of February 8, 1999, there were warrants outstanding to purchase an aggregate of 479,334 shares of Eclipse common stock at exercise prices ranging from $1.67 to $4.17 per share and expiration dates through 1999. All warrants contain provisions for the adjustment of the exercise price upon the occurrence of certain events including stock dividends, stock splits, reorganizations, reclassifications and mergers and terminate upon certain public offerings, mergers or sale of Eclipse assets. Transfer Agent and Registrar. The transfer agent and registrar of the Eclipse common stock is Boston Equiserve LLC and its telephone number is (650) 917-3800. 67
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DESCRIPTION OF CARDIOGENESIS CAPITAL STOCK The authorized capital stock of CardioGenesis consists of 40,000,000 shares of common stock, $0.001 par value per share, and 2,000,000 shares of preferred stock, $0.001 par value per share. CardioGenesis Common Stock. As of the record date, there were 12,385,051 shares of CardioGenesis common stock outstanding held of record by 88 stockholders. Holders of CardioGenesis common stock are entitled to one vote per share on all matters to be voted upon by the stockholders. The holders of CardioGenesis common stock are entitled to receive ratably such dividends, if any, as may be declared from time to time by the CardioGenesis Board out of funds legally available therefor. In the event of a liquidation, dissolution or winding up of CardioGenesis, the holders of CardioGenesis common stock are entitled to share ratably in all assets remaining after payment of liabilities and any liquidation preference on the preferred stock. The CardioGenesis common stock has no preemptive or conversion rights or other subscription rights. There are no redemption or sinking fund provisions applicable to the CardioGenesis common stock. All outstanding shares of CardioGenesis common stock are fully paid and non-assessable. Preferred Stock. CardioGenesis has 2,000,000 shares of preferred stock authorized, of which, as of the record date, no shares were outstanding. The CardioGenesis Board has the authority to provide for the issuance of these shares of preferred stock in one or more series, to establish the number of shares in each series and to fix the designations, powers, preferences, rights, qualifications, limitations and restrictions, without any further vote or action by the stockholders. Although it presently has no intention to do so, the CardioGenesis Board, without stockholder approval, can issue preferred stock with voting and conversion rights which could adversely affect the voting power or other rights of the holders of CardioGenesis common stock and the issuance of preferred stock may have the effect of delaying, deferring or preventing a change in control of CardioGenesis. Transfer Agent and Registrar. The transfer agent and registrar of the CardioGenesis common stock is Boston Equiserve LLC and its telephone number is (650) 917-3800. COMPARISON OF RIGHTS OF STOCKHOLDERS OF CARDIOGENESIS AND SHAREHOLDERS OF ECLIPSE The rights of Eclipse's shareholders are governed by its Amended and Restated Articles of Incorporation, its Amended and Restated Bylaws and the laws of the State of California. The rights of CardioGenesis' stockholders are governed by the CardioGenesis certificate, its bylaws and the laws of the State of Delaware. After the effective time, the CardioGenesis stockholders will become Eclipse shareholders and will be governed by the Eclipse articles, Eclipse bylaws and the laws of the State of California. While the rights and privileges of stockholders of a Delaware corporation such as CardioGenesis are, in many instances, comparable to those of shareholders of a California corporation such as Eclipse, there are certain differences. The following is a summary of the material differences between the rights of holders of CardioGenesis common stock and the rights of holders of Eclipse common stock at the date hereof. These differences arise from differences between the Delaware General Corporation Law and the California Corporation Code and between the CardioGenesis certificate and bylaws, on the one hand, and the Eclipse articles and bylaws, on the other hand. 68
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Vote Required for Extraordinary Transactions. California law requires that the principal terms of a merger be approved by the affirmative vote of at least a majority of the outstanding shares of each class entitled to vote thereon, except that, unless required by its articles of incorporation, no shareholder vote is required of any corporation if such corporation or its shareholders will own, immediately after the merger, more than five-sixths of the voting power of the surviving or acquiring corporation or its parent. The Eclipse articles do not require such a vote or the vote of a greater percentage of the outstanding shares. California law further requires the affirmative vote of at least a majority of the outstanding shares entitled to vote thereon if: - the surviving corporation's articles of incorporation will be amended and would otherwise require shareholder approval; or - shareholders of such corporation will receive shares of the surviving corporation having different rights, preferences, privileges or restrictions (including shares in a foreign corporation) than the shares surrendered. Shareholder approval is not required under California law for mergers or consolidations in which a parent corporation merges or consolidates with a subsidiary of which it owns at least 90% of the outstanding shares of each class of stock. Delaware law requires the affirmative vote of at least a majority of the outstanding stock entitled to vote thereon to authorize any merger or consolidation of a corporation, except that, unless required by its certificate of incorporation, no stockholder vote is required of the surviving corporation if: - such corporation's certificate of incorporation is not amended in any respect by the merger; - each share of stock of such corporation outstanding immediately prior to the effective date of the merger will be an identical outstanding or treasury share of the surviving corporation after the effective date of the merger; and - the number of shares to be issued in the merger does not exceed 20% of such corporation's outstanding common stock immediately prior to the effective date of the merger. The CardioGenesis certificate does not require such a vote or the vote of a greater percentage of the outstanding shares. Stockholder approval is also not required under Delaware law for mergers or consolidations in which a parent corporation merges or consolidates with a subsidiary of which it owns at least 90% of the outstanding shares of each class of stock. Both California law and Delaware law require that a sale of all or substantially all of the corporation's assets be approved by at least a majority of the outstanding stock entitled to vote. Amendment to Governing Documents. Unless otherwise specified in a California corporation's articles of incorporation, an amendment to the articles of incorporation requires the approval of the corporation's board of directors and the affirmative vote of at least a majority of the outstanding shares entitled to vote thereon, either before or after the board approval. The Eclipse articles do not require a greater level of approval for an amendment. 69
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Under California law, the holders of the outstanding shares of a class are entitled to vote as a class if a proposed amendment to the articles of incorporation would: - effect an exchange, reclassification or cancellation of all or part of the shares of such class, including a reverse stock split but excluding a forward stock split. - effect an exchange, or create a right of exchange, of all or part of the shares of another class into the shares of such class. - change the rights, preferences, privileges or restrictions of the shares of such class. - create a new class of shares having rights, preferences or privileges prior to the shares of such class, or increase the rights, preferences or privileges or the number of authorized shares of any class having rights, preference or privileges prior to the shares of such class; or - in the case of preferred shares, divide the shares of any class into series having different rights, preferences, privileges or restrictions or authorize the board of directors to do so. Under California law, a corporation's bylaws may be adopted, amended or repealed either by the board of directors or the shareholders of the corporation. The Eclipse bylaws provide that the bylaws may be adopted, amended or repealed either by the vote or written consent of the holders of a majority of the outstanding shares entitled to vote or by the board of directors; provided, however, that the Eclipse Board of Directors may not amend the Eclipse bylaws in order to change the authorized number of directors (except to alter the authorized number of directors within the existing range of a minimum of four and a maximum of seven directors). Delaware law requires a vote of the corporation's board of directors and the affirmative vote of a majority of the outstanding stock of each class entitled to vote for any amendment to the certificate of incorporation, unless a greater level of approval is required by the certificate of incorporation. The CardioGenesis certificate does not require a greater level of approval for amendments. If an amendment would alter the powers, preferences or special rights of a particular class or series of stock so as to affect them adversely, the class or series will be given the power to vote as a class notwithstanding the absence of any specifically enumerated power in the certificate of incorporation. Delaware law also states that the power to adopt, amend or repeal the bylaws of a corporation will be in the stockholders entitled to vote, provided that the corporation in its certificate of incorporation may confer such power on the board of directors in addition to the stockholders. The CardioGenesis certificate expressly authorizes the CardioGenesis Board of Directors to adopt, amend or repeal the CardioGenesis bylaws. Director Nominations. The CardioGenesis bylaws provide that no nominations for directors of CardioGenesis by any person other than the CardioGenesis Board may be presented to any meeting of stockholders unless the person making the nomination is a record stockholder and has delivered a written notice to the secretary of CardioGenesis. In order to be timely, a stockholder's notice must be delivered between 30 and 60 days prior to the first anniversary of the preceding year's annual meeting; except that if the date of the annual meeting is more than 30 days before or 60 days after the anniversary date, or in the case of a special meeting, the stockholder notice must be delivered between 30 and 60 days prior to such meeting or the 10th day following the day on which public announcement is first made of the date of the meeting. 70
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The Eclipse bylaws impose comparable conditions on the submission of nominations for the election of directors. The Eclipse bylaws require that a shareholder who wishes to submit a nomination for the approval of the Eclipse shareholders at any regular or special meeting of shareholders be a shareholder of record who has delivered a written notice to the secretary of the corporation not less than 90 days prior to such meeting, except that in the event that less than 100 days' notice or prior public disclosure of the date of the meeting is given or made to shareholders, notice by the shareholder must be received not later than the close of business on the 10th day following the day on which such notice of the date of the meeting was mailed or public disclosure was made. Cumulative Voting for Directors. The Eclipse bylaws provide that shareholders are entitled to cumulate their votes to elect directors who have been properly nominated at a shareholders' meeting at which directors are to be elected. Every Eclipse shareholder is entitled to cumulate votes in the following manner: the shareholder can either (a) give one candidate a number of votes equal to the number of directors to be elected multiplied by the number of votes to which that shareholder's shares are normally entitled or (b) distribute the shareholder's votes on the same principle among any or all of the candidates. Votes for directors are then tallied such that candidates receiving the highest number of affirmative votes, up to the number of directors to be elected at such meeting, shall be elected. The CardioGenesis bylaws do not provide for cumulative voting. Instead, the CardioGenesis bylaws provide that on all matters properly to be voted upon by the stockholders, including election of directors, each stockholder is entitled to one vote for each share of stock held by such stockholder. Shareholder Proposals. There is no specific statutory requirement under either California law or Delaware law for advance notice of shareholder proposals. The CardioGenesis bylaws provide that no proposal by any person other than the CardioGenesis Board may be submitted for the approval of the CardioGenesis stockholders at any regular or special meeting of stockholders unless the person advancing the proposal is a record stockholder and has delivered a written notice to the secretary of CardioGenesis between 30 and 60 days prior to the first anniversary of the preceding year's stockholder meeting; except that in the event that the date of the annual meeting is more than 30 days before or more than 60 days after such anniversary date, or in the case of a special meeting, the stockholder notice must be delivered between 30 and 60 days prior to such meeting or the 10th day following the day on which public announcement of the date of such meeting is first made by CardioGenesis. The Eclipse bylaws impose comparable conditions on the submission of shareholder proposals. The Eclipse bylaws require that a shareholder who wishes to submit a proposal for the approval of the Eclipse shareholders at any regular or special meeting of shareholders be a record shareholder who has delivered a written notice to the secretary of the corporation not less than 90 days prior to such meeting, except that in the event that less than 100 days notice or prior public disclosure of the date of the meeting is given or made to shareholders, notice by the shareholder must be received not later than the close of business on the 10th day following the day on which such notice of the date of the meeting was mailed or public disclosure was made. Shareholder Consent in Lieu of Meeting. Under Delaware law and California law, unless otherwise provided in the certificate or articles of incorporation, as the case may be, any action required to be taken or which may be taken at an annual or special meeting of 71
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stockholders may be taken without a meeting if a consent in writing is signed by the holders of outstanding stock having not less than the minimum number of votes that would be necessary to authorize such action at a meeting at which all shares entitled to vote were present and voted. California law and the Eclipse bylaws provide that directors may not be elected by written consent except by unanimous written consent of all shares entitled to vote for the election of directors. However, the Eclipse bylaws allow a director to be elected at any time to fill any vacancy on the Eclipse Board of Directors by written consent of the holders of a majority of the outstanding shares entitled to vote for the election of directors, provided that the vacancy was not created by removal of a director and that it has not been filled by the directors. The CardioGenesis certificate and bylaws provide that any action by the stockholders must be taken at an annual or special meeting of stockholders and may not be taken by written consent. Special Shareholder Meetings. The CardioGenesis bylaws provide that a special meeting of the stockholders may only be called by the Board of Directors, the chairman of the board, the chief executive officer or the president. The Eclipse bylaws provide that a special meeting may only be called by the Eclipse Board of Directors or upon the written request of shareholders entitled to cast not less than 10% of the votes at the meeting. Anti-Takeover Provisions and Interested Stockholder Transactions. Delaware law subjects certain transactions involving a corporation and significant stockholders to special stockholder approval requirements. California law also has provisions that address certain transactions with significant shareholders. Delaware law prohibits, in certain circumstances, a "business combination" between the corporation and an "interested stockholder" within three years of the stockholder becoming an "interested stockholder." An "interested stockholder" is a holder who, directly or indirectly, controls 15% or more of the outstanding voting stock or is an affiliate or associate of the corporation and was the owner of 15% or more of the outstanding voting stock at any time within the prior three-year period. A "business combination" includes generally a merger or consolidation, a sale or other disposition of assets having an aggregate market value equal to 10% or more of the consolidated assets of the corporation or the aggregate market value of the outstanding stock of the corporation and certain transactions that would increase the interested stockholder's proportionate share ownership in the corporation. This three-year moratorium provision does not apply where: - either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder is approved by the corporation's board of directors prior to the date the interested stockholder acquired such 15% interest; - upon the consummation of the transaction which resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the outstanding voting stock of the corporation, excluding for purposes of determining the number of shares outstanding shares held by persons who are directors and also officers and by employee stock plans in which participants do not have the right to determine confidentiality whether shares held subject to the plan will be tendered; - the business combination is approved by a majority of the board of directors and the affirmative vote of two-thirds of the outstanding votes entitled to be cast by disinterested stockholders at an annual or special meeting; 72
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- the corporation does not have a class of voting stock that is listed on a national securities exchange, authorized for quotation on Nasdaq, or held of record by more than 2,000 stockholders unless any of the foregoing results from action taken, directly or indirectly, by an interested stockholder or from a transaction in which a person becomes an interested stockholder; or - the corporation has elected not to be governed by this provision. The CardioGenesis Board has not made an election to be governed by this provision of Delaware law. Under California law, there is no comparable provision. However, California law does provide that, except where the fairness of the terms and conditions of the transaction has been approved by the California Commissioner of Corporations and except in a "short-form" merger of a parent corporation with an at least 90%-owned subsidiary, if the surviving corporation or its parent corporation owns, directly or indirectly, shares of the target corporation representing more than 50% of the voting power of the target corporation prior to the merger, the nonredeemable common stock of a target corporation may be converted only into nonredeemable common stock of the surviving corporation or its parent corporation, unless all of the shareholders of the class consent. The effect of this provision is to prohibit a cash-out merger of minority shareholders, except where the majority shareholders already own 90% or more of the voting power of the target corporation and could, therefore, effect a short-form merger to accomplish such a cash-out of minority shareholders. California law also provides that, with exceptions, when a tender offer or proposal for a reorganization or sale of assets is made by an "interested party" (in general, a controlling or managing party of the target corporation), a fairness opinion regarding the consideration to be paid to the shareholders must be delivered to the shareholders. Furthermore, if a tender offer for shares or vote is sought pursuant to an interested party's proposal and another party makes a later proposal at least 10 days before the date of acceptance of an interested party's tender or proposal, the shareholders must be informed of the later offer and be afforded a reasonable opportunity to withdraw any vote, consent, proxy or tendered shares. Limitation of Liability. Delaware law and California law each provide that the charter documents of a corporation may include provisions which limit or eliminate the liability of directors to the corporation or its stockholders for monetary damages for breach of fiduciary duty as a director. The CardioGenesis certificate contains a provision limiting the personal monetary liability of its directors to the fullest extent permitted by Delaware law. The Eclipse articles contain a provision limiting the liability of its directors to the fullest extent provided by California law. Under Delaware law, this limitation of liability will not apply where the monetary damages arise from: - acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law; - breach of the duty of loyalty; or - the payment of unlawful dividends or expenditure of funds for unlawful stock purchases or redemptions or transactions from which such director derived an improper personal benefit. 73
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Under California law, this limitation of liability will not apply where the monetary damages arise from: - intentional misconduct or knowing and culpable violation of law; - acts or omissions that a director believes to be contrary to the best interests of the corporation or its shareholders or that involve the absence of good faith on the part of the director; - the receipt of an improper personal benefit; - acts or omissions that show reckless disregard for the director's duty to the corporation or its shareholders, where the director in the ordinary course of performing a director's duties was aware or should have been aware of a risk of serious injury to the corporation or its shareholders; - acts or omissions that constitute an unexcused pattern of inattention that amounts to an abdication of the director's duty to the corporation and its shareholders; or - interested transactions between the corporation and a director in which a director has a material financial interest and liability for improper distributions, loans or guarantees. Indemnification. Delaware law provides that a corporation may indemnify its present and former directors, officers, employees and agents against expenses (including attorneys' fees) and, except in actions initiated by or in the right of the corporation, against judgments, fines and amounts paid in settlement actually and reasonably incurred by an indemnitee in actions brought against them, if such person acted in good faith, and in a manner which the person reasonably believed to be in, or not opposed to, the best interests of the stockholders and, in the case of a criminal proceeding, had no reasonable cause to believe the person's conduct was unlawful. The corporation must indemnify an indemnitee to the extent that he or she is successful on the merits or otherwise in the defense of any action, suit or proceeding or the defense of any claim, issue or matter therein. The CardioGenesis bylaws provide for indemnification of directors or officers to the fullest extent authorized by Delaware law. Under Section 317 of the California Corporations Code, a corporation has the power to indemnify present and former directors, officers, employees and agents against expenses, judgments, fines, settlements and other amounts actually and reasonably incurred, other than in connection with actions by or in the right of the corporation, if that person acted in good faith and in a manner the person reasonably believed to be in the best interests of the corporation and, in the case of a criminal proceeding, had no reasonable cause to believe the conduct of the person was unlawful. Furthermore, under Section 317, a corporation has the power to indemnify, with certain exceptions, any person who is a party to any action by or in the right of the corporation, against expenses actually and reasonably incurred by that person in connection with the defense or settlement of the action if the person acted in good faith, and in a manner the person believed to be in the best interests of the corporation and its shareholders. The indemnification authorized by Section 317 of the California Corporations Code is not exclusive, and a corporation may grant its directors, officers, employees or other agents certain additional rights to indemnification. The Eclipse articles and bylaws provide for the indemnification of its agents to the fullest extent permissible under California law, which 74
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may be in excess of the indemnification expressly permitted by Section 317, subject to the limits set forth in Section 204 of the California Corporations Code with respect to actions for breach of duty to the corporation and its shareholders. Delaware law and California law each allow for the advance payment of an indemnitee's expenses prior to the final disposition of an action, provided that the indemnitee undertakes to repay any such amount advanced if it is later determined that the indemnitee is not entitled to indemnification with regard to the action for which the expenses were advanced. Derivative Action. California law provides that a shareholder bringing a derivative action on behalf of the corporation need not have been a shareholder at the time of the transaction in question, if certain tests are met. California law also provides that the corporation or the defendant in a derivative suit may make a motion to the court for an order requiring the plaintiff shareholder to furnish a security bond. Derivative actions may be brought in Delaware by a stockholder on behalf of, and for the benefit of, the corporation. Delaware law provides that a stockholder must plead in the complaint that such stockholder was a stockholder of the corporation at the time of the transaction of which such stockholder complains. A stockholder may not sue derivatively unless such stockholder first makes demand on the corporation that it bring suit and such demand has been refused, unless it is shown that such demand would have been futile. Interested Director Transactions. Under both California law and Delaware law, certain contracts or transactions in which one or more of a corporation's directors (or officers in the case of Delaware law) has an interest are not void or voidable because of such interest provided that certain conditions, such as obtaining the required approval and fulfilling the requirements of good faith and full disclosure, are met. With certain exceptions, the conditions are similar under California law and Delaware law. Under either statute: - the shareholders or the disinterested members of the board of directors must approve any such contract or transaction after full disclosure of the material facts, and in the case of board approval, the contract or transaction must also be "just and reasonable" (in California) or "fair" (in Delaware) to the corporation, or - the contract or transaction must have been just and reasonable or fair as to the corporation at the time it was approved. If the transaction has not been approved by the board of directors or shareholders of the corporation, the burden of proof to show the transaction meets the applicable statutory standard in both California and Delaware rests with the interested party. Under California law, if shareholder approval is sought, the interested director is not entitled to vote his shares at a shareholder meeting with respect to any action regarding such contract or transaction. If Board approval is sought, the contract or transaction must be approved by a majority vote of a quorum of the directors, without counting the vote of any interested directors, except that interested directors may be counted for purposes of establishing a quorum. Under Delaware law, if board approval is sought, the contract or transaction must be approved by a majority of the disinterested directors even though less than a majority of a quorum. Removal of Directors. Under California law, any director or the entire board may be removed, with or without cause, with the approval of a majority of the outstanding shares entitled to vote. However, for corporations like Eclipse that permit cumulative voting, no 75
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director may be removed (unless the entire board is removed) if the number of votes cast against removal would be sufficient to elect the director under cumulative voting. Under Delaware law, a director of a corporation that does not have a classified board may be removed with or without cause by the holders of a majority of the shares then entitled to vote at an election of directors, subject to limitations for corporations that permit cumulative voting. CardioGenesis does not have a classified Board. The CardioGenesis bylaws provide that directors may be removed, with or without cause, at an election of directors. Filling Board Vacancies. Under California law, shareholders may fill any vacancy on the board not otherwise filled by the board. Unless the articles or bylaws provide otherwise, the board may fill any vacancy other than one caused by removal of a director. A vacancy created by removal may be filled only by the shareholders, unless the corporation's articles of incorporation or bylaws also authorize the board to fill such vacancies. The Eclipse bylaws do not permit the Board to fill vacancies created by a vote of the shareholders or court order. Under Delaware law, vacancies and newly-created directorships may be filled by a majority of the directors then in office or by the stockholders, unless otherwise provided in the certificate of incorporation or bylaws. Neither the CardioGenesis certificate nor the CardioGenesis bylaws restrict the ability of its stockholders to fill Board vacancies. Certain Loans. California law requires that any loan or guaranty by the corporation to or for a director or officer must be approved by shareholders, unless extended or granted under a plan approved by shareholders. Shareholders may also approve a bylaw authorizing the corporation's board of directors to approve loans or guaranties to or for officers (including officers who are also directors), if the board determines that the loan or guaranty may reasonably be expected to benefit the corporation. The Eclipse bylaws do not contain such a provision. Under Delaware law, a corporation may make loans to, guarantee the obligations of or otherwise assist its officers or other employees (including any officer or other employee who is also a director) when, in the board's judgment, such action may reasonably be expected to benefit the corporation. Appraisal Rights. Under Delaware law, holders of shares of any class or series have the right, in certain circumstances, to dissent from a merger or consolidation by demanding payment in cash for their shares equal to the fair value (excluding any appreciation or depreciation as a consequence or in expectation of the transaction) of such shares, as determined by agreement with the corporation or by an independent appraiser appointed by a court in an action timely brought by the corporation or the dissenters. Delaware law grants dissenters' appraisal rights only in the case of mergers or consolidations and not in the case of a sale or transfer of assets or a purchase of assets for stock regardless of the number of shares being issued. Further, no appraisal rights are available for shares of any class or series which are listed on a national securities exchange or designated as a national market system security on Nasdaq or held of record by more than 2,000 stockholders, unless the agreement of merger or consolidation converts such shares into anything other than: - stock of the surviving corporation; - stock of another corporation which is either listed on a national securities exchange or designated as a national market system security on Nasdaq or held of record by more than 2,000 stockholders; - cash in lieu of fractional shares; or - some combination of the above. 76
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In addition, dissenters' rights are not available for any shares of the surviving corporation if the merger did not require the vote of the stockholders of the surviving corporation. See "The Reorganization Agreement and Related Agreements -- No Dissenters' or Appraisal Rights" at page 66. Generally, shareholders of a California corporation who dissent from a merger, consolidation or reorganization of the corporation are entitled to exercise dissenters' rights but not in the case of this merger, because Eclipse will survive this merger as the controlling corporation. Dividends and Repurchases of Shares. California law dispenses with the concept of par value and statutory definitions of capital and surplus. Delaware law, however, retains the concept of par value and defines capital and surplus. Under California law, a corporation may not make any distribution (including dividends, whether in cash or other property, and repurchases of its shares) unless the corporation's retained earnings immediately prior to the proposed distribution equal or exceed the amount of the proposed distribution. Alternatively, a corporation may make a distribution if immediately after giving effect to such distribution, the corporation's assets (exclusive of goodwill, capitalized research and development expenses and deferred charges) would be at least equal to 1 1/4 times its liabilities (not including deferred taxes, deferred income and other deferred credits), and the corporation's current assets would be at least equal to its current liabilities (or 1 1/4 times its current liabilities if the average pre-tax and pre-interest expense earnings for the preceding two fiscal years were less than the average interest expense for such years). Such tests are applied to California corporations on a consolidated basis. Delaware law permits a corporation to declare and pay dividends out of surplus. If there is no surplus, a corporation is permitted to declare and pay dividends out of net profits for the fiscal year in which the dividend is declared and/or for the preceding fiscal year as long as the amount of capital of the corporation following the declaration and payment of the dividend is not less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having a preference upon the distribution of assets. In addition, Delaware law generally provides that a corporation may redeem or repurchase its shares only if such redemption or repurchase would not impair the capital of the corporation. Inspection of Shareholder List. Both California law and Delaware law allow any shareholder to inspect the shareholder list for a purpose reasonably related to the shareholder's interest as a shareholder. In addition, California law grants an absolute right to inspect and copy the shareholder list to holders of at least five percent of a corporation's voting shares and holders of at least one percent of such shares who filed a "Schedule 14B" with the SEC relating to the election of directors. Delaware law does not provide an absolute right of inspection. Dissolution. Under California law, holders of shares having 50 percent or more of the corporation's total voting power may authorize a corporation's dissolution without board approval. That right may not be modified by the articles of incorporation. Under Delaware law, unless the board approves the dissolution, the dissolution must be approved by holders of shares having 100 percent of the corporation's voting power. 77
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The foregoing discussion of certain similarities and material differences between the rights of Eclipse shareholders and the rights of CardioGenesis stockholders under their respective articles/certificate of incorporation and bylaws is only a summary of certain provisions and does not purport to be a complete description of such similarities and differences, and is qualified in its entirety by reference to the California Corporations Code and the Delaware General Corporation Law, the common law thereunder and the full text of the articles/ certificate of incorporation and bylaws of each of Eclipse and CardioGenesis. 78
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ECLIPSE AND CARDIOGENESIS UNAUDITED PRO FORMA COMBINED CONDENSED FINANCIAL STATEMENTS The following unaudited pro forma combined condensed financial statements are presented for illustrative purposes only and are not necessarily indicative of the financial position or results of operations that would have actually been reported had the merger occurred at the beginning of the periods presented, nor is it necessarily indicative of future financial position or results of operations. The following unaudited pro forma combined condensed financial statements have been prepared to give effect to the merger using the pooling of interests method of accounting. Both Eclipse and CardioGenesis have calendar year-ends. These unaudited pro forma combined condensed financial statements are based upon the respective historical consolidated financial statements of Eclipse, which are incorporated by reference in this joint proxy statement/prospectus, and of CardioGenesis, which are included elsewhere in this joint proxy statement/prospectus, and should be read in conjunction with the respective historical consolidated financial statements and notes thereto, and do not incorporate, nor do they assume any benefits from costs savings or synergies of, operations of the combined company. The unaudited pro forma combined condensed balance sheet gives effect to the merger as if it had occurred on September 30, 1998 and combines the unaudited consolidated balance sheet of Eclipse and the unaudited consolidated balance sheet of CardioGenesis as of September 30, 1998. The unaudited pro forma combined condensed statements of operations for the nine months ended September 30, 1998 and 1997 and for each of the three years ended December 31, 1997 give effect to the merger as if it occurred as of the beginning of the earliest period presented and are a summation of the historical consolidated statements of operations of Eclipse and CardioGenesis and include no pro forma adjustments. Eclipse and CardioGenesis estimate that they will incur transaction costs of approximately $4.0-$6.0 million in connection with the merger, which will be charged to operations when incurred, principally in the quarter of the completion of the merger. The combined company may incur additional costs in connection with the merger and the integration of the two companies. Management may not be successful in its efforts to integrate the operations of Eclipse and CardioGenesis. See "Risk Factors -- Risks Related to Merger." 79
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UNAUDITED PRO FORMA COMBINED CONDENSED BALANCE SHEET (IN THOUSANDS) ASSETS · Enlarge/Download Table AS OF SEPTEMBER 30, 1998 ---------------------------------------------------- PRO FORMA PRO FORMA CARDIOGENESIS ECLIPSE ADJUSTMENTS COMBINED ------------- ------- ----------- --------- Current assets Cash and cash equivalents......... $ 6,901 $ 2,134 $ 9,035 Marketable securities............. 2,783 252 3,035 Accounts receivable, net.......... 1,633 3,271 4,904 Inventories....................... 1,829 5,350 7,179 Other current assets.............. 1,614 640 2,254 ------- ------- ------- Total current assets...... 14,760 11,647 26,407 Property, plant and equipment..... 1,581 1,269 2,850 Marketable securities (non-current).................. 15,676 14,534 30,210 Other assets...................... 24 1,342 1,366 ------- ------- ------- Total assets.............. $32,041 $28,792 $60,833 ======= ======= ======= LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities Accounts payable and accrued liabilities.................... $ 6,410 $ 5,101 $5,000 $16,511 Deferred revenue.................. 295 -- 295 Note payable...................... -- 1,000 1,000 ------- ------- ------ ------- Total current liabilities............. 6,705 6,101 5,000 17,806 Long term debt, less current portion........................ -- 5 -- 5 ------- ------- ------ ------- Total liabilities......... 6,705 6,106 5,000 17,811 Shareholders' equity.............. 25,336 22,686 (5,000) 43,022 ------- ------- ------ ------- Total liabilities and shareholders' equity.... $32,041 $28,792 $ -- $60,833 ======= ======= ====== ======= The accompanying notes are an integral part of these unaudited pro forma combined condensed financial statements. 80
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UNAUDITED PRO FORMA COMBINED CONDENSED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS) · Enlarge/Download Table FOR THE NINE MONTHS ENDED SEPTEMBER 30, YEAR ENDED DECEMBER 31, -------------------------- ------------------------------- 1998 1997 1997 1996 1995 ----------- ----------- -------- -------- ------- Net revenues.................. $ 9,635 $ 9,372 $ 13,058 $ 13,718 $ 2,707 Cost of revenues.............. 5,937 5,433 7,770 6,424 1,642 -------- -------- -------- -------- ------- Gross profit........ 3,698 3,939 5,288 7,294 1,065 -------- -------- -------- -------- ------- Operating expenses............ Research and development.... 23,279 18,829 26,217 13,726 4,977 Sales and marketing......... 12,668 8,434 12,771 5,744 1,215 General and administrative........... 6,664 5,988 7,758 4,622 1,859 -------- -------- -------- -------- ------- Total operating expenses.......... 42,611 33,251 46,746 24,092 8,051 -------- -------- -------- -------- ------- Operating loss................ (38,913) (29,312) (41,458) (16,798) (6,986) Interest income............... 2,596 3,907 5,301 4,071 184 Interest expense.............. (74) (19) (61) (229) (923) -------- -------- -------- -------- ------- Net loss............ $(36,391) $(25,424) $(36,218) $(12,956) $(7,725) ======== ======== ======== ======== ======= Net loss per share --......... Basic and diluted........... $ (1.35) $ (0.98) $ (1.39) $ (0.65) $ (0.73) ======== ======== ======== ======== ======= Weighted average shares outstanding --.............. 26,877 25,909 26,027 20,020 10,573 ======== ======== ======== ======== ======= The accompanying notes are an integral part of these unaudited pro forma combined condensed financial statements. 81
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NOTES TO UNAUDITED PRO FORMA COMBINED CONDENSED FINANCIAL STATEMENTS 1. PERIODS PRESENTED The unaudited pro forma combined condensed balance sheet gives effect to the merger as if it had occurred on September 30, 1998 and combines the unaudited consolidated balance sheet of Eclipse and the unaudited consolidated balance sheet of CardioGenesis as of September 30, 1998. The unaudited pro forma combined condensed statements of operations for the nine months ended September 30, 1998 and 1997 and the three years ended December 31, 1997 give effect to the merger as if it occurred as of the beginning of the earliest period presented. 2. PRO FORMA NET LOSS PER SHARE The unaudited pro forma combined net loss per share data is based upon the weighted average number of common and potential common shares outstanding of Eclipse and CardioGenesis for each period using an exchange ratio of 0.80 of a share of Eclipse common stock for each share of CardioGenesis common stock. Basic net loss per share is computed using the weighted average common shares outstanding during the period. Diluted net loss per share is computed using the weighted average number of common and potential common shares outstanding during the period. Potential common shares consist of the incremental common shares issuable upon the exercise of stock options (using the treasury stock method). Potential common shares which consist of stock options to purchase 4,770,557 shares of common stock were outstanding at September 30, 1998, but were not included in the computation of pro forma diluted net loss per share because their effect is anti-dilutive. 3. CONFORMING ADJUSTMENTS AND INTERCOMPANY TRANSACTIONS There were no material adjustments required to conform the accounting policies of Eclipse and CardioGenesis. Certain amounts have been reclassified to conform to the pro forma presentation. There are no material intercompany transactions included in the unaudited pro forma combined condensed financial statements. 4. TRANSACTION COSTS Eclipse and CardioGenesis estimate that they will incur transaction and integration costs of approximately $5.0 million in connection with the merger, which will be charged to operations when incurred, principally in the quarter of the completion of the merger. These charges include direct transaction costs of approximately $2,650,000, consisting of financial advisory services of approximately $1,000,000, legal fees of approximately $750,000, accounting fees of approximately $500,000, printing costs of approximately $150,000 and costs of solicitation and registration of approximately $250,000. These charges also include costs of approximately $1,443,000 related to severance of employees and approximately $1,000,000 in costs related to a distribution agreement. An estimated charge of approximately $5.0 million is reflected in the pro forma combined condensed balance sheet but is not reflected in the unaudited pro forma combined condensed statements of 82
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NOTES TO UNAUDITED PRO FORMA COMBINED CONDENSED FINANCIAL STATEMENTS (CONTINUED) operations. This charge is a preliminary estimate only, and is, therefore, subject to change. See "Risk Factors -- Risks Related to Merger -- Expenses related to the merger will have a negative effect on results of operations." 5. ISSUANCE OF ECLIPSE COMMON STOCK The unaudited pro forma combined condensed financial statements reflect the issuance of 0.80 of a share of Eclipse common stock for each share of CardioGenesis common stock outstanding. The following table sets forth the pro forma share issuances in connection with the merger (shares in thousands): · Download Table CardioGenesis common stock outstanding as of September 30, 1998...................................................... 12,266 Exchange ratio.............................................. 0.80:1.0 Pro forma number of shares of Eclipse common stock to be exchanged for CardioGenesis common stock.................. 9,813 Eclipse common stock outstanding as of September 30, 1998... 17,396 Pro forma shares of Eclipse common stock outstanding after completion of the merger as of September 30, 1998......... 27,209 Upon the consummation of the merger, all outstanding options to purchase CardioGenesis common stock will be exchanged for options to purchase Eclipse common stock based upon the exchange ratio of 0.80:1.0. As of September 30, 1998, options to purchase 2,467,369 shares of CardioGenesis common stock were outstanding. 83
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CARDIOGENESIS BUSINESS OVERVIEW The following description of CardioGenesis' business contains forward-looking statements. For a discussion of forward-looking information, see page 28. GENERAL CardioGenesis is developing proprietary probe and catheter systems to perform both surgical and catheter-based percutaneous TMR procedures. TMR procedures are used to treat patients with severe CAD who suffer from recurrent debilitating chest pain known as angina, associated with CAD. Unlike CABG surgery and PTCA procedures, which are used to bypass, reopen or widen blocked or narrowed arteries, TMR procedures involve the use of laser energy, delivered through probes and catheters, to create typically between 15 and 30 channels in the ischemic (oxygen-starved) regions of the heart muscle. Clinical studies of TMR procedures to treat severe angina at some of the world's leading medical centers have demonstrated improvements in clinical conditions and have reported reductions in the frequency of repeated diagnostic procedures and hospitalizations. While the mechanism of the potential clinical benefit of TMR procedures is currently unproven, and additional clinical and mechanism investigations are ongoing, CardioGenesis believes the reported benefits of TMR procedures are associated with angiogenesis, the formation of new blood vessels. CardioGenesis is currently developing three types of TMR systems, based upon its patented technology, for use by cardiothoracic surgeons and interventional cardiologists to treat patients with severe CAD. CardioGenesis' ITMR system and TTMR system use an epicardial approach (i.e., creating channels from outside the heart into the left ventricle) and its PMR system uses an endocardial approach (i.e., creating channels from inside the left ventricle partially through the myocardium). CardioGenesis' objective is to establish the TMR procedure as a conventional therapy to treat CAD and to become the worldwide market leader of TMR systems. To establish CardioGenesis as the leading provider of TMR systems, CardioGenesis intends to continue to conduct clinical trials at, and focus its marketing efforts on, high volume, prestigious cardiovascular centers. CardioGenesis' clinical efforts have been focused on patients with severe angina for whom existing therapies cannot be used (so-called "no-option" patients). CardioGenesis plans to conduct clinical trials to broaden the applications for its TMR systems to cover multiple indications, including use as an adjunct to other interventional therapies, such as CABG and PTCA procedures. CardioGenesis intends to build upon its domestic and international intellectual property position, particularly its issued percutaneous and intraoperative TMR method patents. CardioGenesis seeks to rapidly establish a large installed base of its TMR systems in key international markets, emerging secondary markets, and, following FDA approval, in the United States, thereby creating an opportunity for a recurring revenue stream from the sale of its disposable probes and catheters. To help achieve this goal, CardioGenesis entered into an exclusive international distribution agreement with Boston Scientific in January 1997. See " -- Termination of Relationship with Boston Scientific" for information regarding the termination of the agreement. Additionally, CardioGenesis intends to invest significant resources in research and development and to enhance its understanding of the TMR mechanism to enable it to 84
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further develop its products and to promote widespread adoption of TMR in the medical community. CARDIOGENESIS TMR APPROACHES AND MARKETS CardioGenesis' proprietary TMR systems are designed to create channels either epicardially or endocardially. CardioGenesis' ITMR system and TTMR system use an epicardial approach and its PMR system uses an endocardial approach. ITMR. In an intraoperative TMR procedure, the heart is exposed by a cardiothoracic surgeon through either a thoracotomy (an incision through the chest wall) or a sternotomy (an incision through the sternum). CardioGenesis' ITMR probe is then applied directly onto the myocardium delivering laser energy to create channels into the left ventricle. CardioGenesis initiated Phase I feasibility clinical trials with the ITMR System in "no-option" patients in November 1995. In June 1996, CardioGenesis received approval from the FDA to expand its multi-center ITMR clinical trial to a Phase II, prospective, randomized clinical trial in "no-option" patients. Enrollment in the Phase II, randomized, no-option trial is now complete. CardioGenesis is nearing completion of its submission of data and information on the CardioGenesis CardioSync ITMR system in a modular format to the FDA. The FDA has requested that CardioGenesis delay submission of the final clinical package until the agency catches up with their September 30, 1998 fiscal year end backlog. CardioGenesis is not aware of any FDA issues with their modular submission to date. CardioGenesis believes its relationship with the FDA remains strong, and does not believe that this request will slow CardioGenesis' progress toward a PMA panel date or ultimate FDA approval. In August 1996, CardioGenesis received an IDE from the FDA and has begun a clinical study of its ITMR system used as an adjunctive therapy to CABG in patients with severe angina who are only partially treatable by CABG. The adjunct to CABG clinical trial is ongoing. PMR. CardioGenesis' percutaneous PMR system is designed to be used by an interventional cardiologist in a cardiac catheterization laboratory. In this procedure, the cardiologist accesses the heart by inserting a fiber optic equipped catheter system into the femoral artery at the groin and then advancing it through the aorta into the left ventricle. Once in the ventricle, the fiber optic catheter is guided to the ischemic areas of the endocardial wall surface to create channels partially through the wall of the heart. CardioGenesis believes that PMR, as a catheter-based procedure, is less invasive, less traumatic, and more cost-effective than other TMR approaches. In November 1996, CardioGenesis initiated clinical testing in Europe of its PMR system in "no-option" patients. In July 1997, CardioGenesis received an IDE from the FDA which allows a multi-center clinical trial of its PMR system to treat angina in no-option patients at up to twelve clinical sites. TTMR. In a thoracoscopic TMR procedure, a TTMR probe is used by a cardiothoracic surgeon in combination with endoscopic instruments to access and visualize the heart. Through these endoscopic instruments, the TTMR probe is maneuvered and placed on the beating heart delivering laser energy to create channels into the left ventricle. CardioGenesis believes the approaches discussed above may be used for a number of CAD indications. However, none of CardioGenesis' TMR systems has received FDA approval, 85
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and there can be no assurance any of these approaches will receive FDA approval for any of the indications discussed below or will be accepted by the medical community as viable methods for the treatment of CAD. See "Risk Factors -- Risks Related to Business of Eclipse and CardioGenesis." POTENTIAL INDICATIONS CardioGenesis believes the three approaches it is developing could be used to address a range of indications for TMR therapy and estimates each year there are more than 500,000 patients in the United States and other key markets who could potentially benefit from TMR therapy. "No-option." TMR therapy is currently being studied as a treatment for patients with severe CAD not treatable by PTCA, CABG or other interventional therapies. These patients have severe diffuse multivessel CAD and may have undergone multiple prior cardiac procedures. CardioGenesis believes all of its TMR systems could be used in the treatment of "no-option" patients. Adjunct to CABG. TMR therapy is also currently being studied in combination with CABG, in cases where the patient has one or more areas of the heart afflicted by severe CAD that cannot be adequately bypassed. In these cases, the coronary arteries that can be bypassed are grafted, while other areas that are ischemic and not suitable for bypass are treated with TMR therapy. CardioGenesis believes its ITMR and TTMR systems could address this potential indication. Adjunct to PTCA. CardioGenesis believes its proprietary PMR system may be used in combination with a PTCA procedure, where there is evidence of severely ischemic regions of the heart not amenable to treatment with PTCA alone. In this situation, CardioGenesis' PMR system would be used to treat the regions of the heart where a PTCA procedure is not effective. None of CardioGenesis' TMR systems has been proven to be safe or efficacious nor has CardioGenesis received regulatory approval to market any of its TMR systems in the United States. See "Risk Factors -- Risks Related to Business of Eclipse and CardioGenesis." PRODUCTS CardioGenesis' TMR systems include disposable fiber optic probes and catheters for transmitting laser energy to the myocardium, a Ho:YAG laser unit, and an electrocardiogram monitor, which are described below. Disposable Fiber Optic Probes and Catheters. The proprietary probes used in CardioGenesis' ITMR and TTMR systems and the proprietary catheters used in CardioGenesis' PMR System are flexible, fiber-optic based devices for positioning and transmitting laser energy to create channels through the wall of the heart. The tip of the probe includes a proprietary lens apparatus that creates laser energy distribution to allow for progressive, controlled penetration of the myocardium. A highly flexible optical fiber, encased within a protective fiber jacket, transmits energy to the lens from the laser. The probes and catheters are designed as disposable single-use devices. The PMR aligning catheter can be directed anywhere into the left ventricle. The catheter system permits steering within the ventricle to guide the optical system to the appropriate areas of the heart wall. Once the 86
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catheter system is oriented toward the target to be treated, the lens is independently advanced to the ventricular wall assuring perpendicular contact on the myocardial wall. Ho:YAG Laser. CardioGenesis' TMR systems incorporate a proprietary Ho:YAG laser specifically designed for TMR applications. CardioGenesis' current laser is a portable unit, weighing approximately 140 pounds, which delivers laser energy. CardioGenesis believes that the Ho:YAG laser is optimally suited for TMR procedures because of: - its tissue ablation characteristics; - its ability to deliver treatment energy through a fiber optic device, thereby allowing percutaneous applications; - its reliability when compared with other types of lasers; and - its ability to be manufactured cost-effectively. ECG Monitor. CardioGenesis' TMR systems include a commercially available, microprocessor-controlled ECG monitor and a CardioGenesis proprietary software algorithm. This ECG monitor provides the means for timing the firing of CardioGenesis' laser to the patient's cardiac electrical activity. Based on early research sponsored by CardioGenesis and conducted at a major academic institution, CardioGenesis believes timing the laser to the patient's cardiac electrical activity may be a significant factor in minimizing the occurrence of arrhythmias (irregular heartbeats). CardioGenesis' TMR systems are designed to offer the following advantages: - Flexible System Design. CardioGenesis' TMR systems are designed to deliver laser energy in a progressive, controlled manner through a fiber optic probe or catheter, providing CardioGenesis with a technology adaptable for multiple approaches and indications. - Price/Performance. CardioGenesis has designed its TMR systems to be cost- effective, enabling flexibility in the pricing of its laser systems and disposable probes and catheters. CardioGenesis believes that this flexibility will enable it to offer superior price/performance to its customers. - Size and Portability. CardioGenesis' current TMR systems weigh approximately 140 pounds, are portable and do not occupy a significant amount of space in an operating room or cardiac catheterization laboratory. - Reliability. The Ho:YAG laser used in CardioGenesis' TMR systems is a solid state laser designed for reliability, thereby minimizing maintenance costs. CardioGenesis' TMR systems are also designed to meet and withstand the rigors of shipment, installation, repeated use, and relocation within the hospital environment. In July 1996, CardioGenesis received the CE Mark approval to market its ITMR system in the European Community. The CE Mark is granted to companies whose products meet the essential requirements of the MDD and provides the regulatory approval necessary for commercialization in the European Community. In October 1996, at the European Association of Cardio-Thoracic Surgery's annual meeting in Prague, Czech Republic, CardioGenesis commercially launched the ITMR system in Europe. In January 1998, CardioGenesis received the CE Mark approval for use of its PMR system in the European Community. 87
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CardioGenesis is not currently developing any products outside the field of TMR therapy. Consequently, CardioGenesis is dependent on the successful development and commercialization of CardioGenesis' TMR systems. See "Risk Factors -- Risks Related to Business of Eclipse and CardioGenesis. MARKETING, SALES AND DISTRIBUTION CardioGenesis' marketing strategy is designed to generate broad market acceptance of the TMR procedure based on demonstrated clinical efficacy and cost-effectiveness. CardioGenesis' strategy includes developing and maintaining close working relationships with key cardiothoracic surgeons and interventional cardiologists who practice at major cardiac care centers. CardioGenesis seeks to rapidly establish a large installed base of its TMR systems in key international markets and emerging secondary markets thereby creating an opportunity for a recurring revenue stream from the sale of its disposable probes and catheters. CardioGenesis expects that education and awareness of cardiothoracic surgeons, interventional cardiologists and patients as to the benefits of CardioGenesis' TMR systems will be a key component of its marketing and sales effort for its TMR probe and catheter systems. CardioGenesis currently supports and intends to support rigorous clinical research designed to support the safety and efficacy of its TMR systems. In addition, to increase awareness of its TMR systems, CardioGenesis has encouraged and intends to encourage the appropriate presentation of the results of this research by the research investigators at major national and international medical symposia and by the publication of clinical and scientific reports of such results in major peer-reviewed publications. In the United States, CardioGenesis intends to market its products, if approved by the FDA, with a direct sales organization. CardioGenesis has deployed a U.S. sales force. However, additional resources will be required to develop a sales force capable of effectively commercializing CardioGenesis' TMR systems in the United States. Failure to build an effective sales and marketing organization could have a material adverse effect on CardioGenesis' business, financial condition and results of operations. Until such time, if ever, as the FDA approves CardioGenesis' TMR systems for marketing in the United States, CardioGenesis anticipates it will continue to derive a significant portion of its revenues from international sales. Even if FDA approval is obtained, CardioGenesis expects international sales will continue to account for a significant portion of CardioGenesis' total revenues. As a result, a significant portion of CardioGenesis' revenues both before and after such approval is obtained will be subject to the risks associated with international sales. See "Risk Factors -- Risks Related to Business of Eclipse and CardioGenesis. On January 22, 1999, CardioGenesis entered into an Authorized Distributor Agreement with Eclipse, under which CardioGenesis was appointed as the exclusive distributor of the Eclipse holmium laser system and certain related products for certain states or portions of certain states in the United States. The parties decided in mid-January 1999 to enter into the distributor agreement to generate revenues for both Eclipse and CardioGenesis from sales by CardioGenesis of Eclipse products pending the merger. The distributor agreement allows CardioGenesis to set its own resale prices to end-users. CardioGenesis has no minimum commitments under the distributor agreement. CardioGenesis will maintain no 88
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inventory of Eclipse products; the products will be drop-shipped by Eclipse directly to customers of CardioGenesis. The distributor agreement may be terminated by either party upon sixty days' prior written notice, and terminates automatically upon FDA approval of CardioGenesis' products for sale in the U.S. There is no requirement under the Agreement, nor any expectation by CardioGenesis or Eclipse, that the distributor agreement will be renewed after its termination. The distributor agreement contains customary post-termination obligations for CardioGenesis relating to the maintenance and availability of records, cessation of use of trademarks and logos of Eclipse, payment of outstanding invoices, and return of advertising and similar materials. CardioGenesis does not believe that any sales made by it of Eclipse products during the term of the distributor agreement will materially adversely impact its ability to sell its own products, following FDA approval of such products, if the merger does not occur. TERMINATION OF RELATIONSHIP WITH BOSTON SCIENTIFIC In early January 1999, CardioGenesis sent Boston Scientific written notice terminating the Boston Scientific agreement because of various breaches by Boston Scientific of its obligations under the agreement. The notice also demanded that Boston Scientific make required payments to CardioGenesis and make the required minimum purchases of CardioGenesis products for the fourth quarter of 1998 and for calendar year 1998. If the breaches by Boston Scientific are not cured within the time periods specified in the agreement, the agreement will terminate. Subsequently, CardioGenesis sent additional termination notices to Boston Scientific relating specifically to Boston Scientific's failure to timely cure its payment breach and to timely place and pay for the required minimum purchase order. CardioGenesis decided to terminate the agreement because of its belief, after numerous discussions with Boston Scientific over the past year and taking into account Boston Scientific's past breaches, that Boston Scientific will be unable to, or will not, devote the required resources and focus to marketing and sales of CardioGenesis products. Boston Scientific has disputed CardioGenesis' right to terminate the agreement. CardioGenesis has contested, and intends further if necessary to vigorously contest, such dispute. While the parties are currently in settlement discussions, the costs to CardioGenesis, and the outcome, of any such dispute are not quantifiable at this time. Boston Scientific does not have the right under the Boston Scientific agreement to terminate the Boston Scientific agreement as a result of the merger. CardioGenesis has no obligation to repurchase any inventory from Boston Scientific upon such termination. CardioGenesis would have no other contingent obligations to Boston Scientific under the Boston Scientific agreement after such termination, other than: - customary obligations to sell to Boston Scientific or to end-users parts for CardioGenesis products that had previously been sold to the end-users by Boston Scientific; - to work with Boston Scientific to transfer from Boston Scientific to CardioGenesis any end-user leases and rentals of CardioGenesis products placed by Boston Scientific; 89
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- payment of any amounts owed by CardioGenesis to Boston Scientific under the Boston Scientific agreement that had accrued prior to the date of termination; - customary warranty obligations; and - customary survival of confidentiality and record-keeping obligations. Due to the early, developing stage of the international markets for CardioGenesis' products, and the state of development of its own international sales and marketing staff, CardioGenesis believes that the termination of the Boston Scientific agreement and the subsequent transition will not have a material adverse effect on CardioGenesis, whether or not the merger is consummated. Given the expected closing date of the merger, and the normal process of product integration that would typically follow such closing, CardioGenesis does not anticipate that the effective date of such termination, as determined under the Boston Scientific agreement, will materially adversely impact the ability of the combined company to determine and implement the timing and scope of such integration. CLINICAL TRIALS ITMR. Clinical data from CardioGenesis' prospective randomized ITMR trial presented at recent medical symposia indicate that patients who received treatment with the ITMR System achieved approximately a two class drop in angina class as measured on the Canadian Cardiovascular Society Angina Scale and a 45 percent improvement in exercise tolerance, as opposed to no improvement in angina class or exercise tolerance in study patients who did not receive the ITMR therapy. There are no reported operative deaths in CardioGenesis' randomized study and the mortality rate in the ITMR therapy group is less than six percent. Enrollment in the Phase II, randomized, no-option trial is now complete. CardioGenesis is nearing completion of its submission of data and information on the CardioGenesis CardioSync ITMR System in a modular format to the FDA. The FDA has requested that CardioGenesis delay submission of the final clinical package until the agency catches up with their September 30, 1998 fiscal year end backlog. CardioGenesis is not aware of any FDA issues with their modular submission to date. CardioGenesis believes its relationship with the FDA remains strong, and does not believe that this request will slow CardioGenesis' progress toward a PMA panel date or ultimate FDA approval. Adjunct to CABG. In August 1996, CardioGenesis launched an additional prospective, randomized, multi-center clinical study under an FDA authorized IDE to evaluate the ITMR therapy as an adjunct to CABG surgery in up to 500 patients at up to 25 clinical sites. PMR. Pilot clinical studies for the PMR system were first conducted in Europe in November 1996 and CardioGenesis treated the first U.S. human patient in July 1997. CardioGenesis was the first company to initiate clinical studies of a minimally invasive percutaneous approach to transmyocardial revascularization. More than 350 patients have been treated with the PMR system at clinical investigation centers in the U.S. and Europe. In July 1997, CardioGenesis received an IDE from the FDA which allows a multi-center clinical trial of the Axcis PMR system to treat angina in no-option patients. Enrollment and treatment for the prospective randomized Phase II trial of CardioGenesis' Axcis PMR system has been completed and the trials are ongoing with three, six and twelve month 90
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patient follow ups. The trial, which includes over 290 patients, is being conducted at 12 major cardiovascular treatment centers in both the U.S. and Europe. CardioGenesis plans to pursue a modular submission for regulatory approval and intends to submit information and updates for the formal follow up period of the study. This proactive and collaborative approach to submission provides CardioGenesis with a means for frequent reviews by the FDA of information required for PMA of the Axcis PMR system. Clinical data presented at recent medical symposia indicate patients treated with the PMR system are achieving angina class reductions and exercise tolerance improvements comparable to those achieved by patients treated with the ITMR system. Due to the severity of the underlying illnesses of the patients in this population, CardioGenesis expects the use of its TMR systems to be accompanied by a certain level of patient morbidity and mortality. There can be no assurance any clinical investigations CardioGenesis conducts when completed, will provide sufficient safety and effectiveness data and information to support a PMA application and to obtain FDA marketing approval. See "-- Government Regulation" and "Risk Factors -- Risks Related to Business of Eclipse and CardioGenesis." MANUFACTURING GENERAL CardioGenesis' manufacturing activities conducted at its facility in Sunnyvale, California consist of assembly and testing of the fiber optic probe and catheter systems used for the TMR procedures. CardioGenesis has developed various proprietary processes used to manufacture its probes and catheters. CardioGenesis uses third party suppliers to manufacture the Ho:YAG laser and ECG monitor included in its TMR systems and for other services and operations including sterilization of its products. CardioGenesis' facilities include a controlled environment room where most assembly operations are performed. CardioGenesis has complied with various international regulatory requirements including meeting ISO 9001/EN 46001 and MDD requirements and has obtained a CE Mark approval to market both the ITMR System and the PMR System in Europe. Before the FDA will approve a PMA application, it will inspect CardioGenesis' manufacturing facilities and processes for compliance with FDA regulations. CardioGenesis' manufacturing facilities have not yet been inspected by the FDA. In the event additional manufacturing sites are added or manufacturing processes are changed, such new facilities and processes are also subject to regulatory inspection for compliance with United States and international regulations. See "-- Government Regulation" and "Risk Factors -- Risks Related to Business of Eclipse and CardioGenesis." SUPPLIERS A major component used in CardioGenesis' TMR systems, the ECG monitor, is currently available from a sole source. In addition, several other components used in CardioGenesis' TMR systems are purchased by CardioGenesis from a single supplier. CardioGenesis periodically conducts assessments of alternative vendors for various components used in its TMR systems. However, the qualification of additional or replacement vendors for certain components is a lengthy process. See "Risk Factors -- Risks Related to Business of CardioGenesis and Eclipse." 91
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Commencing in the fourth quarter 1997, CardioGenesis began purchasing lasers from Carl Baasel Lasertechnik GmbH under an OEM Product Development and Supply Agreement. Under the Baasel OEM agreement, CardioGenesis has exclusive rights to sell or otherwise distribute the laser on a worldwide basis either incorporated into CardioGenesis' products or on a stand-alone basis. The Baasel OEM agreement prohibits Baasel from selling or otherwise distributing the laser in the configuration developed for and used by CardioGenesis' TMR systems to any third party unless approved in advance in writing by CardioGenesis. During the term of the Baasel OEM agreement and for a period of one year thereafter, Baasel is prohibited from making a laser, or any major subassembly of a laser, that is the same or as functionally equivalent to CardioGenesis' laser for use competitive with that of CardioGenesis. PATENTS AND PROPRIETARY RIGHTS CardioGenesis relies on a combination of patent, trade secret, copyright and trademark laws and contractual restrictions to establish and protect proprietary rights in its TMR systems. CardioGenesis holds seven patents in the United States. One of CardioGenesis' United States patents is directed to methods of PMR therapy, in which a catheter system is inserted through a patient's vascular system into the heart, and energy is applied to the inner wall of the heart creating revascularization in the myocardium. Two of CardioGenesis' United States patents are directed to methods of ITMR and TTMR therapies, where a flexible probe is inserted into a patient's chest cavity and energy is applied to the outer wall of the heart creating revascularization through the heart muscle. These patents expire in the year 2012. CardioGenesis also has two patents, which expire in the year 2009, one directed to a specialized lens and means for securing the lens to an optical fiber to provide a desirable energy emission pattern and one of which is related to a system for detecting broken optical fibers. CardioGenesis also has a patent which expires in the year 2013 relating to a reinforced optical fiber system. CardioGenesis has 28 United States patent applications pending and intends to file additional patent applications on various features of its TMR systems in the future. CardioGenesis has 15 international patent applications pending and intends to file additional international patent applications corresponding to most of the pending United States patent applications. Several of the pending patent applications have received Notices of Allowance, and CardioGenesis expects one or more U.S. patents to issue. However, there can be no assurance additional patents will issue with respect to any currently pending or future patent application. The medical device industry has been characterized by extensive litigation regarding patents and other intellectual property rights, and some companies in the medical device industry have employed intellectual property litigation to attempt in whole or, in part, to gain a competitive advantage. Certain of CardioGenesis' competitors and potential competitors have obtained United States patents covering technology that could be used for certain TMR procedures, and there can be no assurance such competitors, potential competitors or others have not filed and do not hold international patents covering other TMR technology. See "Risk Factors -- Risks Related to Business of Eclipse and CardioGenesis." RESEARCH AND DEVELOPMENT CardioGenesis' research and development efforts to date have been focused on development of CardioGenesis' ITMR, PMR and TTMR systems. CardioGenesis is committed to enhancing the medical community's knowledge and acceptance of TMR therapy for the 92
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treatment of severe angina. CardioGenesis intends to continue its basic research of the TMR mechanism and to focus on the expansion of the indications and approaches for using its TMR systems, in particular its PMR system. In addition, CardioGenesis will continue to address improvements in the devices that are a part of the TMR systems, including improvements which may reduce the cost of its TMR systems. Based on its research, CardioGenesis believes the reported reduction in chest pain, improvement in exercise tolerance, and perceived long-term increase in myocardial blood flow may be associated with the formation of new blood vessels (angiogenesis). Further product research and development by CardioGenesis will require substantial expenditures and has inherent risks, and there can be no assurance CardioGenesis will be successful in identifying products for which demand exists or in developing products that have the characteristics necessary to treat particular indications, or that any new products introduced by CardioGenesis will receive regulatory approval or be commercially successful. Total research and development expenses of CardioGenesis were approximately $14.2 million, $7.1 million, and $4.0 million for the years ended December 31, 1997, 1996 and 1995, respectively, and approximately $12.3 million for the nine months ended September 30, 1998. Research and development work by CardioGenesis related to TMR therapy is being carried out at Columbia University under an agreement that has been extended into 1999. Under this agreement, CardioGenesis has a worldwide exclusive license to any patents that issue in connection with the research conducted. The license also includes a paid up, exclusive worldwide license to use and disclose (subject to certain nondisclosure requirements) information, data and know-how relating to the subject matter of the research and CardioGenesis' products resulting from the research. The license may become nonexclusive, at the election of Columbia, if CardioGenesis fails to use reasonable efforts to develop and market the products resulting from the research for commercial sale and distribution throughout the world. The license also contains certain most-favored licensing provisions in the event that the license becomes nonexclusive. The agreement provides for the payment of certain royalties by CardioGenesis to Columbia based on its net revenues from products to the extent such products include the patented technology developed by Columbia under the agreement, including any sales made under an IDE. These royalties are offset by funds advanced by CardioGenesis and prior sponsors to whom CardioGenesis is a successor under the Columbia agreement to fund such research of Columbia. CardioGenesis is not required to pay royalties to Columbia under the agreement until certain conditions are met, and such conditions have not been met. COMPETITION The TMR market is intensely competitive and is constantly becoming more competitive. Some of CardioGenesis' competitors and many of its potential competitors have substantially greater name recognition and capital resources than does CardioGenesis and also may have greater resources and expertise in the areas of research and development, obtaining regulatory approvals, manufacturing and marketing. The TMR market is characterized by rapid technical innovation. Accordingly, CardioGenesis' competitors may succeed in developing TMR products or procedures that are more effective or more effectively marketed than products marketed by CardioGenesis or may render CardioGenesis' technology obsolete. Additionally, even if CardioGenesis' products provide performance comparable to competing products, CardioGenesis may not be able to obtain necessary regulatory approvals to compete against competitors in terms of manufacturing, marketing 93
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and sales. In the field of TMR products, both Eclipse and PLC have received favorable PMA review from the FDA and have received regulatory approvals and begun to market products in Europe. In addition, PLC has received FDA approval to commercially market a TMR product in the U.S. Earlier entrants in the market in a therapeutic area often obtain and maintain greater market share than later entrants. CardioGenesis believes the primary competitive factors in the market for TMR systems include clinical performance, product safety and reliability, availability of third party reimbursement, product design specifically for TMR product use, product quality, ease of use, price of systems and disposable components, customer service, and company reputation. In addition, the length of time required for products to be developed and receive regulatory approval and the ability to use patents or other proprietary rights to prevent sales by competitors are also important competitive factors. CardioGenesis believes it competes favorably with respect to these factors, although certain competitors are at a more advanced stage in the clinical trial and regulatory approval processes. There can be no assurance CardioGenesis will be able to continue to compete successfully in the future with respect to any or all of the factors that are or may be relevant to success in its markets. Many of the medical indications that may be treatable with TMR therapy are currently being treated by drug therapies or surgery and other interventional therapies, including CABG and PTCA therapies. A number of these therapies are widely accepted in the medical community, have a long history of use and continue to be enhanced rapidly. Procedures using TMR therapy may not be able to replace or augment such established treatments or clinical research may not support the use of TMR therapy. Additionally, new surgical procedures and new drug therapies are being developed to treat CAD. These new procedures and drug therapies could be more effective, safer or more cost-effective than TMR therapy. If TMR therapy fails to replace or augment existing therapies or its therapies are not more effective, safer or cost-effective than new therapies, CardioGenesis' business, financial condition and results of operations could be materially adversely affected. See "Risk Factors -- Risks Related to Business of Eclipse and CardioGenesis." GOVERNMENT REGULATION UNITED STATES CardioGenesis' TMR systems and accessories are regulated in the United States as medical devices. As such, CardioGenesis is subject to extensive regulation by the FDA and state and local authorities including the CDHS. Under the authority of the FD&C Act and related regulations, the FDA regulates the pre-clinical and clinical testing, manufacture, labeling, distribution, sale, marketing, advertising and promotion of medical devices. Noncompliance with applicable requirements can result in, among other things, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, refusal of the government to grant PMA approval under Section 515 of the FD&C Act or premarket notification clearance under Section 510(k) of the FD&C Act, withdrawal of marketing clearances or approvals, or a recommendation by the FDA that CardioGenesis not be permitted to enter into government contracts and criminal prosecution. In certain circumstances, the FDA also has the authority to order recall, repair, replacement of or refund of the cost of, a device manufactured or distributed by CardioGenesis. To date, none of CardioGenesis' products has been approved for sale in the United States. FDA approval of a PMA for the relevant TMR system will be required before such TMR system can be marketed in the United States. 94
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In the United States, medical devices are classified as Class I, II or III on the basis of the controls deemed by the FDA to be necessary to reasonably assure their safety and effectiveness. Class I devices are subject to general controls (e.g., labeling, premarket notification and adherence to FDA-mandated current good manufacturing practice GMP requirements), and Class II devices are subject to general controls and special controls (e.g., performance standards, postmarket surveillance, patient registries and FDA guidelines). Generally, Class III devices are those that must receive premarket approval by the FDA to assure their safety and effectiveness (e.g., life-sustaining, life-supporting and implantable devices, or new devices which have been found not to be substantially equivalent to legally marketed devices). Class III devices usually require clinical testing and FDA approval prior to marketing and distribution. CardioGenesis' TMR systems are Class III devices. Before a new medical device can be introduced into the market, the manufacturer generally must obtain FDA clearance of a 510(k) or approval of a PMA under Section 515 of the FD&C Act. A PMA application is required if a proposed device is not substantially equivalent to a legally marketed Class I or Class II device, or if it is a Class III device for which the FDA has called for PMAs. A PMA must be supported by valid scientific evidence that typically includes extensive data, including biocompatability data, preclinical study data (e.g., bench testing, laboratory and animal studies) and clinical study data, to demonstrate the safety and efficacy of the device. If human clinical trials of a device are required and the device presents, in the FDA's view, a "significant risk," the sponsor of the trial (usually the manufacturer or the distributor of the device) is required to file an IDE application with the FDA prior to commencing human clinical trials. The IDE application must be supported by data, typically including the results of animal and laboratory testing. If the IDE application is approved by the FDA and by one or more appropriate institutional review boards (IRBs), human clinical trials may begin at a specific number of investigational sites with a specific number of patients, as approved by the FDA. If the sponsors and all reviewing IRBs conclude that the device presents a "nonsignificant risk" to the patient, a sponsor may begin clinical trials after obtaining approval for the study protocol by one or more of the appropriate IRBs, without the need for FDA approval of the study protocol. Spon