ERBA Diagnostics, Inc. 10-K 2007
Documents found in this filing:
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Amendment No. 1
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
IVAX Diagnostics, Inc.
(Exact name of registrant as specified in its charter)
2140 North Miami Avenue, Miami, Florida 33127
(Address of principal executive offices, including zip code)
(Registrants telephone number, including area code)
Securities Registered Pursuant to Section 12(b) of the Act:
Securities Registered Pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ¨ No x
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ¨ No x
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrants knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. x
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer ¨ Accelerated filer ¨ Non-accelerated filer x
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes¨ No x
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant on June 30, 2006, was approximately $14,206,000, computed by reference to the price at which the common equity was last sold on the American Stock Exchange on such date.
As of April 25, 2007, there were 27,649,887 shares of common stock outstanding.
Documents Incorporated by Reference:
This Annual Report on Form 10-K/A is being filed by IVAX Diagnostics, Inc. to amend the Annual Report on Form 10-K, which it had filed with the Securities and Exchange Commission on March 30, 2007, to include the remaining information required by Items 10-14 of Part III of Form 10-K.
IVAX Diagnostics, Inc.
Annual Report on Form 10-K/A
for the year ended December 31, 2006
TABLE OF CONTENTS
Directors and Executive Officers
Information with respect to the directors and executive officers of IVAX Diagnostics, Inc. (the Company) is set forth in the Companys Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 30, 2007.
Section 16(a) Beneficial Ownership Reporting Compliance
Section 16(a) of the Securities Exchange Act of 1934 requires the Companys directors, executive officers and 10% stockholders to file initial reports of ownership and reports of changes in ownership of common stock and other equity securities of the Company with the Securities and Exchange Commission and the American Stock Exchange. Directors, executive officers and 10% stockholders are required to furnish the Company with copies of all Section 16(a) reports they file. Based on a review of the copies of such reports furnished to the Company and written representations from directors and executive officers of the Company that no other reports were required, the Company believes that its directors, executive officers and 10% stockholders complied with all Section 16(a) filing requirements applicable to them for the year ended December 31, 2006.
Code of Conduct and Ethics
The Companys Board of Directors has adopted a Code of Conduct and Ethics, which applies to all of the Companys directors, officers and employees, and a code of ethics, also known as a Senior Financial Officer Code of Ethics, which applies to the Companys principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. The Code of Conduct and Ethics and the Senior Financial Officer Code of Ethics are posted in the Investor Relations section of the Companys Internet web site at www.ivaxdiagnostics.com. If the Company makes an amendment to, or grants a waiver with respect to, any provision of the Senior Financial Officer Code of Ethics, then the Company intends to disclose the nature of such amendment or waiver by posting it in the Investor Relations section of the Companys Internet web site at www.ivaxdiagnostics.com or by other appropriate means as required or permitted under the applicable regulations of the Securities and Exchange Commission and rules of the American Stock Exchange.
Audit Committee Members and Financial Expert
The members of the Audit Committee of the Board of Directors are Fernando L. Fernandez, Glenn L. Halpryn and Jose J. Valdes-Fauli. The Board of Directors has determined that the Audit Committee has two audit committee financial experts as such term is defined in Item 407(d)(5) of Regulation S-K. The Board of Directors determined that each of Messrs. Fernandez and Valdes-Fauli has the attributes, education and experience of an audit committee financial expert and that each of Messrs. Fernandez and Valdes-Fauli is independent as such term is defined in the applicable regulations of the Securities and Exchange Commission and rules of the American Stock Exchange relating to directors serving on audit committees.
Compensation Discussion and Analysis
Overview of Compensation Program
The Companys Compensation Committee administers the compensation program for the Companys executive officers. The Compensation Committee reviews and determines all executive officer compensation, administers the Companys equity incentive plans (including reviewing and approving grants to the Companys executive officers), makes recommendations to shareholders with respect to proposals related to compensation matters and generally consults with management regarding employee compensation programs.
The Board determines the Compensation Committees membership. Glenn L. Halpryn, Chairman, Mark W. Durand, Fernando L. Fernandez and John B. Harley, M.D., comprise the Compensation Committee. The Compensation Committee meets at regularly scheduled times during the year, and it may also hold specially scheduled meetings and take action by written consent.
The Companys executive officers, each of whom is included in the Summary Compensation Table below, are: Giorgio DUrso, Chief Executive Officer, President and Director; Duane M. Steele, Vice PresidentBusiness Development; and Mark S. Deutsch, Chief Financial Officer and Vice President Finance. Throughout this Annual Report on Form 10-K/A, these individuals are referred to collectively as the Named Executive Officers.
Compensation Philosophy and Objectives
The Companys compensation program for the Named Executive Officers has historically consisted of a base salary, an annual cash incentive program and periodic grants of stock options. The Compensation Committee believes that the most effective executive officer compensation program is one that is designed to align the interests of the Named Executive Officers with those of the stockholders by compensating the Named Executive Officers in a manner that advances both the short- and long-term interests of the Company and its stockholders. The Compensation Committee believes that the Companys compensation program for the Named Executive Officers is appropriately based upon the performance of the Company, the performance and level of responsibility of the Named Executive Officer and market data regarding the value of the executive officers position at comparable companies.
Role of Executive Officers in Compensation Decisions
The Compensation Committee makes all compensation decisions for the Named Executive Officers and approves recommendations regarding equity awards to all employees of the Company. The Chief Executive Officer annually reviews the performance of each of
the Named Executive Officers (other than the Chief Executive Officer, whose performance is reviewed by the Compensation Committee). The conclusions reached and recommendations based on these reviews, including those with respect to setting and adjusting base salary, annual cash incentive awards and stock option awards, are presented to the Compensation Committee. The Compensation Committee can exercise its discretion in modifying upward or downward any recommended amounts or awards to the Named Executive Officers. In 2006, the Compensation Committee did not exercise this discretion.
Named Executive Officer Compensation Components
For the fiscal year ended December 31, 2006, base salary was the principal component of compensation for the Named Executive Officers, as the Companys compensation program for the Named Executive Officers did not include an annual cash incentive program or long-term equity incentive compensation.
The Compensation Committee believes that the base salaries offered by the Company are competitive based on a review of market practices and the duties and responsibilities of each Named Executive Officer. In setting base salaries, the Compensation Committee periodically examines market compensation levels and trends observed in the market for executives of comparable experience and skills. In addition to examining market compensation levels and trends, the Compensation Committee makes base salary decisions for the Named Executive Officers based on an annual review by the Compensation Committee with input and recommendations from the Chief Executive Officer. The Compensation Committees review includes, among other things, the functional and decision-making responsibilities of each position, the significance of the Named Executive Officers specific area of individual responsibility to the Companys financial performance and achievement of overall goals, and the contribution, experience and work performance of each Named Executive Officer. The Chief Executive Officer is party to an employment agreement with the Company, which establishes his minimum base salary of $348,519. This employment agreement is more fully described under the Potential Payments upon Termination or Change-in-Control Table below. In addition to the minimum base salary established by this employment agreement, when determining the Chief Executive Officers base salary, the Compensation Committee makes an assessment of Mr. DUrsos past performance as Chief Executive Officer and its expectations as to his future contributions to the Company, as well as the factors described above for the other Named Executive Officers, including examining market compensation levels and trends and evaluating his individual performance and the Companys financial condition, operating results and attainment of strategic objectives. While the Chief Executive Officers 2006 base salary did not change from 2005, the other Named Executive Officers 2006 base salaries increased 5% from 2005.
Annual Cash Incentive Program
The Compensation Committee believes that the Companys annual incentive program should be utilized to promote high performance and achievement of shorter-term corporate strategic goals and initiatives and encourage the growth of stockholder value. Accordingly, in 2006, the Companys compensation program for the Named Executive Officers did not include an annual cash incentive program, primarily as a result of the overall position of the Company not meeting its financial targets as the Compensation Committee had expected. In prior years, however, the Companys annual incentive program has been a cash bonus plan which was tied to the achievement of pre-established, objective Company-wide annual financial performance goals. These goals were established each year during the Companys annual budget cycle. The annual incentive program was designed to promote high performance and achievement of shorter-term corporate strategic goals and initiatives, encourage the growth of stockholder value, and allow the Named Executive Officers to participate in the growth and profitability of the Company.
Long-Term Equity Incentive Compensation
In 2006, the Companys compensation program for the Named Executive Officers did not include long-term equity incentive compensation. In prior years, however, the Companys long-term equity incentive compensation program has provided an opportunity for the Named Executive Officers to increase their stake in the Company through grants of options to purchase shares of the Companys common stock and encouraged the Named Executive Officers to focus on long-term Company performance by aligning the Named Executive Officers interests with those of the Companys stockholders, since the ultimate value of such compensation is directly dependent on the stock price. In prior years, the Compensation Committees grant of stock options to the Named Executive Officers has been partly discretionary based upon an assessment of the individual Named Executive Officers contribution to the success and growth of the Company and partly tied to the achievement of pre-established, objective Company-wide annual financial performance goals. The discretionary component of decisions by the Compensation Committee regarding grants of stock options to the Named Executive Officers (other than the Chief Executive Officer) have been generally made based upon the recommendation of the Chief Executive Officer, the level of the Named Executive Officers position with the Company, an evaluation of the Named Executive Officers past and expected future performance and the number of outstanding and previously granted stock options to the Named Executive Officer.
Compensation Committee Report
The following Report of the Compensation Committee does not constitute soliciting material and should not be deemed filed or incorporated by reference into any other Company filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except to the extent the Company specifically incorporates this Report by reference therein.
The Compensation Committee has reviewed and discussed the Companys Compensation Discussion and Analysis with management. Based on this review and discussion, the Compensation Committee recommended to the Board of Directors that the Companys Compensation Discussion and Analysis be included in this Annual Report on Form 10-K/A.
Submitted by the Members of the Compensation Committee:
Glenn L. Halpryn, Chairman
Mark W. Durand
Fernando L. Fernandez
John B. Harley, M.D.
Compensation of Named Executive Officers
Summary Compensation Table 2006
The following table sets forth certain summary information concerning compensation paid or accrued by the Company to or on behalf of the Named Executive Officers (as defined in the Compensation Discussion and Analysis section above) for the fiscal year ended December 31, 2006.
During the year ended December 31, 2006, the Companys compensation program for the Named Executive Officers did not include any equity or non-equity incentive compensation plans and there were no grants of stock option awards to the Named Executive Officers.
Outstanding Equity Awards at Fiscal Year-End 2006
The following table sets forth certain information regarding equity-based awards held by the Named Executive Officers as of December 31, 2006.
During the year ended December 31, 2006, there were no stock option exercises by the Named Executive Officers.
Potential Payments upon Termination or Change-in-Control
The following table sets forth certain information with respect to compensation that would become payable if the Named Executive Officers had ceased employment under the various circumstances below. The amounts shown assume that such cessation of employment was effective as of December 31, 2006. The actual amounts to be paid can only be determined at the time of such executives separation from the Company.
Compensation of Directors
The Companys Compensation Committee recommends director compensation to the Board based on factors it considers appropriate, market conditions and trends and the recommendations of management. In 2006, each of the Companys non-employee directors received a cash retainer of $15,000 for his service on the Board. Additionally, each member of the Audit Committee and each member of the Compensation Committee received cash retainers of $5,000 and $2,500, respectively, for his service on such committees during 2006. In addition to cash compensation, each of the Companys non-employee directors was awarded a grant of options to purchase 25,000 shares of the Companys common stock under the Companys 1999 Performance Equity Plan with an exercise price of $1.56 per share, which was the closing price of the Companys common stock on the American Stock Exchange on September 19, 2006, and which fully vested immediately upon grant. Directors who are employed by the Company, Teva Pharmaceutical Industries Limited or Teva North America do not receive any compensation for their service on the Board or the committees of the Board.
Director Compensation 2006
The following table sets forth certain information regarding the compensation paid to the Companys non-employee directors for their service during the fiscal year ended December 31, 2006.
Compensation Committee Interlocks and Insider Participation
From January 1, 2006 until April 19, 2006, the Compensation Committee of the Board of Directors consisted of Neil Flanzraich, Chairman, Glenn L. Halpryn, and John B. Harley, M.D. On April 19, 2006, Mr. Flanzraich resigned from the Board of Directors and the Compensation Committee. On August 9, 2006, Fernando L. Fernandez and Mark W. Durand were each appointed to the Compensation Committee and Mr. Halpryn was appointed Chairman of the Compensation Committee and, since such time, Messrs. Halpryn, Durand and Fernandez and Dr. Harley have comprised the Compensation Committee. From May 1998 until January 2006, Mr. Flanzraich had served as the Vice Chairman and President of IVAX Corporation (IVAX). See Transactions with Related Persons below for a description of certain transactions between IVAX, Teva Pharmaceutical Industries Limited (Teva) and the Company.
Security Ownership of Certain Beneficial Owners and Management
The following table indicates, as of April 25, 2007, information about the beneficial ownership of the Companys common stock by (1) each director, (2) each executive officer, (3) all directors and executive officers as a group, and (4) each person who the Company knows beneficially owns more than 5% of its common stock. All such shares were owned directly with sole voting and investment power unless otherwise indicated.
Equity Compensation Plan Information
The following table sets forth information, as of December 31, 2006, with respect to compensation plans under which shares of the Companys common stock are authorized for issuance.
Review, Approval or Ratification of Transactions with Related Persons
During 2006, the Company had a policy for the review of transactions in which the Company was a participant, the amount involved exceeded $120,000 and any of the Companys directors or executive officers, or their immediate family members, had a direct or indirect material interest. Any such related person transaction was to be for the benefit of the Company and upon terms no less favorable to the Company than if the related person transaction was with an unrelated party. While this policy was not in writing during 2006, the Chief Financial Officer was responsible for maintaining a list of all existing related person transactions. During 2006, no related person transaction occurred where this policy was not followed.
In March 2007, the Board of Directors adopted a written policy for the review and pre-approval or ratification, as applicable, of transactions in which the Company was a participant, the amount involved exceeded $120,000 and any of the Companys directors or executive officers, or any of their immediate family members, had a direct or indirect material interest. This policy requires the Audit Committees review and pre-approval, or ratification if pre-approval is not feasible, of any such related person transaction. When considering a related person transaction under this policy, the Audit Committee analyzes the following factors, in addition to any other factors it deems appropriate: whether the terms of the related person transaction are fair to the Company; whether the related person transaction is material to the Company; the role the related person has played in arranging the related person transaction; the structure of the related person transaction; and the interest of the related person in the related person transaction.
Transactions with Related Persons
Upon completion of the merger of the pre-merger IVAX Diagnostics, the Company entered into a registration rights agreement with IVAX, the Companys approximately 72.3% stockholder which, on January 26, 2006, merged into a wholly-owned subsidiary of Teva. The registration rights agreement required the Company to file a registration statement on Form S-3 (at any time after one year, and before the earlier of five years, following the completion of the merger or such time at which all the shares of the Companys common stock owned by IVAX can be sold in any three-month period without registration) to register not less than $1.0 million of the Companys common stock owned by IVAX. Additionally, IVAX was permitted to piggyback on registrations initiated by the Company or other holders exercising similar demand registration rights. The registration rights agreement expired on March 15, 2006.
In connection with the merger of the pre-merger IVAX Diagnostics, the Company entered into a shared services agreement with IVAX pursuant to which IVAX would continue to provide administrative and management services previously provided by IVAX to the pre-merger IVAX Diagnostics prior to the merger at IVAX cost plus 15% for a period of three months. These services may include payroll, including printing paychecks and making associated tax filings; treasury, including cash management services such as disbursements, receipts, banking and investing; insurance, including procuring and administering policies; human resources, including administering employee benefits and plans; financial reporting, including public reports, income taxes; and information systems, including network and website hosting, phone and data systems, software licenses and information systems support.
In connection with the merger of the pre-merger IVAX Diagnostics, the Company entered into a use of name license with IVAX that grants the Company a non-exclusive, royalty free license to use the name IVAX. IVAX may terminate the license upon 90 days written notice. Upon termination of the agreement, the Company must take all steps reasonably necessary to change its name as soon as practicable. If IVAX abandons its use of the name, IVAX must transfer all rights to the name to the Company. The termination of this agreement by IVAX could have a material adverse affect on the Companys ability to market its products and on the Company.
Prior to, and for a short time after, Tevas acquisition of IVAX, the Company, as a subsidiary of IVAX, had directors and officers insurance as well as property insurance coverage that fell within the scope of IVAX directors and officers insurance and property insurance policies. In 2006, the Company purchased its own directors and officers insurance and property insurance policies and, accordingly, no longer falls within the scope of Tevas or IVAX directors and officers insurance or property insurance policies.
Giulio DUrso, the son of the Companys Chief Executive Officer and President, has been engaged by the Companys subsidiaries and the Company for total annual compensation of $164,792. Due to currency exchange rate fluctuations, this amount of compensation may vary from year-to-year.
The Board of Directors has determined that four of the members of the Board of DirectorsFernando L. Fernandez, Glenn L. Halpryn, John B. Harley, M.D., and Jose J. Valdes-Fauliare independent as such term is defined in the applicable rules of the American Stock Exchange relating to the independence of directors. In determining that Dr. Harley is independent, the Board of Directors considered the oral consulting agreement between Dr. Harley and ImmunoVision, pursuant to which Dr. Harley is paid $2,000 per month to provide ImmunoVision with technical guidance and business assistance on an as-needed basis. The Board of Directors also considered the license agreement between the Company and JK Autoimmunity, a corporation of which Dr. Harley is the controlling shareholder, pursuant to which JK Autoimmunity has granted an exclusive worldwide license to the Company for certain patents, rights and technology relating to monoclonal antibodies against autoimmune RNA proteins developed by Dr. Harley in exchange for specified royalty payments, including an annual minimum royalty of $10,000 for each licensed product utilized by the Company.
The following table sets forth the aggregate fees billed to the Company by PricewaterhouseCoopers LLP, the Companys principal accountant for the fiscal year ended December 31, 2006, and Ernst & Young LLP, the Companys principal accountant for the fiscal year ended December 31, 2005.
In the table above, pursuant to their definitions under the applicable regulations of the Securities and Exchange Commission, audit fees are fees for professional services rendered for the audit of the Companys annual financial statements and review of the Companys financial statements included in the Companys Quarterly Reports on Form 10-Q and for services that are normally provided by the accountant in connection with statutory and regulatory filings or engagements; audit-related fees are fees for assurance and related services that are reasonably related to the performance of the audit and review of the Companys financial statements, and primarily include accounting consultations and audits in connection with potential acquisitions; tax fees are fees for tax compliance, tax advice and tax planning; and all other fees are fees for any services not included in the first three categories.
The Audit Committee is responsible for pre-approving all audit services and permitted non-audit services to be performed by the Companys principal accountant, except in those instances which do not require such pre-approval pursuant to the applicable regulations of the Securities and Exchange Commission. The Audit Committee has established policies and procedures for its pre-approval of audit services and permitted non-audit services and, from time to time, the Audit Committee reviews and revises its policies and procedures for pre-approval.
The following exhibits are filed as a part of this Annual Report on Form 10-K/A:
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.