Filed by Bowne Pure Compliance
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-K/A
(Amendment No. 1)
(Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the fiscal year ended December 31, 2006
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from
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to
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COMMISSION FILE NO. 0-26224
INTEGRA LIFESCIENCES HOLDINGS
CORPORATION
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
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DELAWARE
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51-0317849 |
(STATE OR OTHER JURISDICTION OF
INCORPORATION OR ORGANIZATION)
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(I.R.S. EMPLOYER IDENTIFICATION NO.) |
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311 ENTERPRISE DRIVE
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08536 |
PLAINSBORO, NEW JERSEY
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(ZIP CODE) |
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES) |
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REGISTRANTS TELEPHONE NUMBER, INCLUDING AREA CODE: (609) 275-0500
SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT:
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Title of Each Class
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Name of Exchange on Which Registered |
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Common Stock, Par Value $.01 Per Share
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The Nasdaq Stock Market LLC |
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 o No þ
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or
15(d) of the Securities Exchange Act. Yes o No þ
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 þ No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K 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. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
As of June 30, 2007, the aggregate market value of the registrants common stock held by
non-affiliates was approximately $624.8 million based upon the closing sales price of the
registrants common stock on The Nasdaq Global Market on such date. The number of shares of the
registrants Common Stock outstanding as of May 13, 2008 was 27,307,058.
DOCUMENTS INCORPORATED BY REFERENCE: NONE
EXPLANATORY NOTE
Integra LifeSciences Holdings Corporation (the Company) is filing this amended Annual Report
on Form 10-K/A for the fiscal year ended December 31, 2007 (the Amendment) solely to amend Part
II, Item 9A (Controls and Procedures) to add one sentence expressly stating, under Managements
Report on Internal Control over Financial Reporting, that the Companys internal control over
financial reporting was not effective as of December 31, 2007 as a result of the material
weaknesses identified. Other than this additional sentence, the text of Item 9A remains unchanged
in all respects.
In accordance with Rule 12b-15 under the Securities Exchange Act of 1934, as amended, the
Company has also filed with the Amendment under Part IV, Item 15 the certifications set forth in
Exhibits 31.1, 31.2, 32.1, 32.2. No modification or update is otherwise made to any other
disclosures or exhibits to the Annual Report on Form 10-K for the fiscal year ended December 31,
2007 (the Original Filing) originally filed on May 16, 2008 with the Securities and Exchange
Commission (the Commission). Accordingly, this Amendment should be read in conjunction with the
Companys filings made with the Commission subsequent to the date of the Original Filing.
PART II
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Exchange Act reports is recorded, processed, summarized and
reported within the time periods specified in the Securities and Exchange Commissions rules and
forms and that such information is accumulated and communicated to our management, including our
chief executive officer and chief financial officer, as appropriate, to allow for timely decisions
regarding required disclosure. Disclosure controls and procedures, no matter how well designed and
operated, can provide only reasonable assurance of achieving the desired control objectives, and
management is required to apply its judgment in evaluating the cost-benefit relationship of
possible controls and procedures. Management has designed our disclosure controls and procedures
to provide reasonable assurance of achieving the desired control objectives.
As required by Exchange Act Rule 13a-15(b), we have carried out an evaluation, under the
supervision and with the participation of our management, including our principal executive officer
and principal financial officer, of the effectiveness of the design and operation of our disclosure
controls and procedures as of December 31, 2007. Based upon this evaluation, our principal
executive officer and principal financial officer concluded that our disclosure controls and
procedures were not effective as of December 31, 2007 because of the material weaknesses discussed
below. Notwithstanding the material weaknesses discussed below, our management has concluded that
the consolidated financial statements included in this Annual Report on Form 10-K fairly present in
all material respects our financial condition, results of operations and cash flows for the periods
presented in conformity with generally accepted accounting principles.
Managements Report on Internal Control Over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over
financial reporting as defined in Rules 13a-15(f) under the Securities Exchange Act of 1934, as
amended. Internal control over financial reporting is designed to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles in the United States
of America (GAAP). We recognize that because of its inherent limitations, internal control over
financial reporting may not prevent or detect misstatements. Also, projections of any evaluation
of effectiveness to future periods are subject to the risk that controls may become inadequate
because of changes in conditions, or that the degree of compliance with the policies and procedures
may deteriorate.
To evaluate the effectiveness of our internal control over financial reporting, management
used the criteria described in Internal Control Integrated Framework issued by the Committee of
Sponsoring Organizations of the Treadway Commission (COSO).
In conducting our evaluation of the effectiveness of our internal control over financial
reporting, we have excluded Precise, IsoTis, Physician Industries and LXU from our assessment of
internal control over financial reporting as of December 31, 2007 because they were acquired by the
Company in purchase business combinations during 2007. Precise Dental Holding Corporation and
subsidiaries, IsoTis, Inc. and subsidiaries, Physician Industries, Inc. and LXU Healthcare, Inc.
and subsidiaries are wholly owned entities of the Company whose total assets and total revenues
represent approximately 14% and 7%, respectively, of the related consolidated financial statement
amounts as of and for the year ended December 31, 2007.
A material weakness in internal control over financial reporting is a deficiency, or a
combination of deficiencies, such that there is a reasonable possibility that a material
misstatement of the annual or interim financial statements will not be prevented or detected on a
timely basis. In connection with managements assessment of our internal control over financial
reporting, we identified the following material weaknesses in our internal control over financial
reporting as of December 31, 2007.
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The Company did not maintain a sufficient complement of personnel with the appropriate
skills, training and experience to identify and address the application of generally
accepted accounting principles and effective controls with respect to locations undergoing
change or experiencing staff turnover. Specifically, the Company did not maintain a
sufficient complement of personnel to completely and accurately record and review the
inventory, accrued liabilities, intercompany accounts, account receivable and income taxes
accounts as of and for the year ended December 31, 2007. Further, effective communication
was not designed and in place for sharing of information within and between our finance
department and other operating departments. This control deficiency contributed to the
following control deficiencies which are individually considered to be material weaknesses. |
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The Company did not maintain effective controls over certain financial statement
accounts reconciliation. Specifically, accounts reconciliation involving inventory,
accrued liabilities, intercompany accounts, account receivable and income taxes were not
designed for proper preparation and timely review and reconciling items were not timely
resolved and adjusted. This control deficiency resulted in audit adjustments to the
aforementioned accounts and disclosures in the Companys consolidated financial statements
as of and for the year ended December 31, 2007. |
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The Company did not maintain effective controls over the recording and elimination of
Intercompany transactions. Specifically, controls were not appropriately designed for
completeness and accuracy of Intercompany accounts and to reconcile and review intercompany
transactions between the Companys subsidiaries on a timely basis. This control deficiency
resulted in improper intercompany profit eliminations and audit adjustments to intercompany
sales and cost of goods sold for the year ended December 31, 2007. |
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The Company did not maintain effective controls over the completeness and accuracy of
its income tax provision. Specifically, controls were not appropriately designed to ensure
its income tax provision and related income taxes payable and deferred income tax assets
and liabilities were properly calculated. This control deficiency resulted in audit
adjustments to the aforementioned accounts and disclosures in the Companys consolidated
financial statements as of and for the year ended December 31, 2007. |
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The Company did not maintain effective controls over the system configuration,
segregation of duties and access to key financial reporting systems, particularly with
respect to locations undergoing systems implementations. Specifically, key financial
reporting systems were not appropriately configured to ensure that certain transactions
were properly processed, to segregate duties amongst personnel and to ensure that
unauthorized individuals did not have access to add, change or delete key financial data.
Further, the Company lacked adequate internal access security policies and procedures. |
Because of these material weaknesses, management has concluded that our internal control over
financial reporting was not effective as of December 31, 2007. These control deficiencies could
result in misstatements of financial statement accounts and disclosures that would result in a
material misstatement of the consolidated financial statements that would not be prevented or
detected.
The effectiveness of the Companys internal control over financial reporting as of December
31, 2007 has been audited by PricewaterhouseCoopers LLP, an independent registered public
accounting firm, as stated in their report which appears herein.
Management Action Plan and Progress to Date
In response to the material weaknesses, we have taken certain actions and will continue to
take further steps to strengthen our control processes and procedures in order to remediate such
material weaknesses. We will continue to evaluate the effectiveness of our internal controls and
procedures on an ongoing basis and will take further action as appropriate. These actions include
an assessment of intercompany accounts and the reconciliation process with the assistance of
outside consultants. This was helpful not only in connection with previous quarterly closes, but
also identified a number of process improvements which will be implemented in future monthly and
quarterly closes.
Additionally, we have taken and are taking the following actions to remediate the material
weaknesses identified above:
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On September 6, 2007, we accepted the resignation of our Chief Financial
Officer. |
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Reassigned our former corporate controller from the business development
department to the finance organization to assist with the quarterly close and
process improvements. |
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Recruited additional accounting and tax professionals who can provide the
adequate experience and knowledge to improve the timeliness and effectiveness of
our account reconciliations and ultimately the financial reporting processes.
Several individuals have been hired within the finance organization and management
continues to recruit additional personnel. We have utilized our internal audit
group and outside consultants as needed to assist with executing the preparation
and/or reviews of reconciliations under our direction. Training for current and
new personnel is being addressed. We also have developed a group that is solely
dedicated to developing and administrating training materials to departmental
personnel as well as enhancing communication channels among departments and
organizations within the company. |
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Enhancements to the reconciliation process have been made during the 2007 fiscal
year. Reconciliations are being reviewed by several levels of management prior to
finalization. In addition, during the first quarter of 2008, management developed
reconciliation policies and procedures that will be administered to all departments
in 2008. |
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Management continues to address the control weaknesses around intercompany
accounting transactions. Detailed intercompany reconciliations will be prepared
each period and analyzed by several levels of management. Process changes are
being identified and implemented, which enforce compliance with existing and
revised processes for intercompany transactions and allow for easier accounting and
monitoring of such transactions. Process improvements are still being analyzed and
addressed by management. |
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Several individuals have been hired in the tax department. These individuals
have been working on assessing the current tax structure and reviewing the
transactions in the tax accounts. Management will continue working on addressing
the control weaknesses as it relates to assessing and recording tax transactions. |
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The Company performed a detailed study related to its controls associated with
the use of its primary financial reporting system and has a working group in place
focused on implementing the key findings from that assessment. The Business
Process Management team was established and has been recruiting IT and project
management professionals with the necessary knowledge and experience to continue
the optimization efforts around the Companys Enterprise Resource Planning system
(ERP) and supporting business processes. The team continues its planning around
additional phases of ERP rollouts in international locations and the integration of
acquired businesses. We expect the remediation in this area to continue for a
number of months. |
The effectiveness of any system of controls and procedures is subject to certain limitations,
and, as a result, there can be no assurance that our controls and procedures will detect all errors
or fraud. A control system, no matter how well conceived and operated, can provide only
reasonable, not absolute, assurance that the objectives of the control system will be attained.
We will continue to develop new policies and procedures as well as educate and train our
financial reporting department regarding our existing policies and procedures in a continual effort
to improve our internal control over financial reporting, and will be taking further actions as
appropriate. We view this as an ongoing effort to which we will devote significant resources.
We believe that the foregoing actions have improved and will continue to improve our internal
control over financial reporting, as well as our disclosure controls and procedures.
Changes in Internal Control Over Financial Reporting
There were no material changes in our internal control over financial reporting (as defined in
Rule 13a-15(f) under the Exchange Act) that occurred during the quarter ended December 31, 2007
that have materially affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
Exhibits
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31.1
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Certification of Principal Executive Officer Pursuant to Section 302
of the Sarbanes-Oxley Act of 2002 |
31.2
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Certification of Principal Financial Officer Pursuant to Section 302
of the Sarbanes-Oxley Act of 2002 |
32.1
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Certification of Principal Executive Officer Pursuant to Section 906
of the Sarbanes-Oxley Act of 2002 |
32.2
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Certification of Principal Financial Officer Pursuant to Section 906
of the Sarbanes-Oxley Act of 2002 |
SIGNATURES
Pursuant to the requirements of Section 13 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.
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INTEGRA LIFESCIENCES HOLDINGS CORPORATION |
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Date: July 31, 2008
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By:
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/s/ Stuart M. Essig |
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Stuart M. Essig
President and Chief Executive Officer |
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 in the capacities indicated.
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Signature |
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President, Chief Executive Officer and
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July 31, 2008 |
Stuart M. Essig
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Director (Principal Executive Officer) |
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/s/ John B. Henneman, III
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Executive Vice President, Finance and
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July 31, 2008 |
John B. Henneman, III
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Administration, and Chief Financial Officer
(Principal Financial Officer) |
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Vice President and Corporate Controller
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July 31, 2008 |
Jerry E. Corbin
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(Principal Accounting Officer) |
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/s/ Richard E. Caruso, Ph.D.
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Chairman of the Board
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July 31, 2008 |
Richard E. Caruso, Ph.D. |
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/s/ Thomas J. Baltimore, Jr.
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Director
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July 31, 2008 |
Thomas J. Baltimore, Jr. |
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Director
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Keith Bradley, Ph.D. |
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Director
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July 31, 2008 |
Neal Moszkowski
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Director
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July 31, 2008 |
Christian Schade
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Director
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July 31, 2008 |
James M. Sullivan |
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Director
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July 31, 2008 |
Anne M. VanLent |
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EXHIBIT INDEX
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Exhibit Number |
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Description |
31.1
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Certification of Principal Executive Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 |
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31.2
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Certification of Principal Financial Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 |
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32.1
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Certification of Principal Executive Officer Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 |
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32.2
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Certification of Principal Financial Officer Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 |