e8vk
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): May 3, 2011
WRIGHT MEDICAL GROUP, INC
(Exact Name of Registrant as Specified in Charter)
|
|
|
|
|
Delaware
|
|
000-32883
|
|
13-4088127 |
|
(State or Other Jurisdiction
of Incorporation
|
|
(Commission
File Number)
|
|
(IRS Employer
Identification No.) |
|
|
|
5677 Airline Road,
Arlington, Tennessee
|
|
38002 |
|
(Address of Principal Executive Offices)
|
|
(Zip Code) |
Registrants telephone number, including area code: (901) 867-9971
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy
the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
|
o |
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
o |
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
o |
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
o |
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. Results of Operations and Financial Condition.
On May 4, 2011, Wright Medical Group, Inc. issued a press release announcing, among other things,
preliminary financial results for the first quarter ended March 31, 2011 and containing information concerning
a conference call to discuss such results. A copy of the press release is set forth in Exhibit 99.1 hereto and
is incorporated herein by reference.
The information in this Current Report, including exhibits
attached hereto, is being furnished and shall not be deemed filed for the purposes of Section 18
of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section.
The information in this Current Report, including exhibits attached hereto, shall not be incorporated by reference
into any registration statement or other document pursuant to the Securities Act of 1933, except as may otherwise
be expressly stated in such filing.
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On May 4, 2011, the Company announced that Thomas L. McAllister has been appointed interim General
Counsel and Secretary by the Board of Directors, replacing Raymond C. Kolls, Senior Vice President,
General Counsel and Secretary, effective May 4, 2011.
Mr. McAllister, age 44, has been our Assistant General Counsel since 2005 and held various other
legal positions from 2002 2005. Prior to joining us, Mr. McAllister practiced law for
approximately ten years. The Board has not yet established any compensation arrangements for Mr.
McAllisters service as interim General Counsel and Secretary.
Mr. Kolls resigned from the Company without good reason effective May 3, 2011. Because Mr. Kolls
resignation was without good reason the Company has no obligations to him other than payment of
accrued obligations. In general, the Company will be obligated to pay Mr. Kolls accrued salary
earned through May 3, 2011 and the value of accrued but untaken vacation, and to reimburse him for
unreimbursed business expenses, but Mr. Kolls is not entitled to severance pay under any employment
or separation pay agreement or otherwise.
In addition, Alicia M. Napoli, Vice President, Clinical & Regulatory Affairs, and Cary P. Hagan,
Sr. Vice President, Commercial Operations Europe, Middle East and Africa, also resigned from the
Company without good reason effective May 3 and 4, 2011, respectively.
Item 8.01. Other Information
In December 2007, we received a subpoena from the United States Department of Justice (DOJ) through
the United States Attorneys Office for the District of New Jersey (USAO) requesting documents for
the period January 1998 through the present related to any consulting and professional service
agreements with orthopaedic surgeons in connection with hip or knee joint replacement procedures or
products. This subpoena was served shortly after several of our knee and hip competitors agreed to
resolutions with the DOJ after being subjects of investigations involving the same subject matter.
On September 29, 2010, our wholly-owned subsidiary, Wright Medical Technology, Inc. (WMT) entered
into a 12-month Deferred Prosecution Agreement (DPA) with the USAO and a Civil Settlement Agreement
(CSA) with the United States. Under the DPA, the USAO agreed not to prosecute WMT in connection
with the matter if WMT satisfies its obligations during the 12 month term of the DPA. Pursuant to
the CSA, WMT settled civil and administrative claims relating to the matter for a payment of $7.9
million without any admission by WMT. In conjunction with the CSA, WMT also entered into a five
year Corporate Integrity Agreement (CIA) with the Office of the Inspector General of the United
States Department of Health and Human Services (OIG). The DPA and the CIA were filed as Exhibits
10.27 and 10.26, respectively, to the Companys quarterly report filed on October 29, 2010. The DPA
has also been posted to the Companys website.
Pursuant to the DPA, an independent monitor has been retained to review and evaluate WMTs
compliance with its obligations under the DPA. As a result of the work of the independent monitor
and WMTs compliance program, the Board of Directors became aware of facts indicative of possible
compliance issues. At the direction of the Nominating, Compliance and Governance Committee of the
Board of Directors of WMTs parent, Wright Medical Group, Inc. (WMGI), WMGI and WMT have
conducted an internal investigation with the assistance of outside counsel. The Board of Directors
of WMGI received a report from outside counsel. On May 4, 2011, pursuant to Paragraph 20 of the
DPA, WMT provided written notice to the independent monitor and the USAO of credible evidence of
serious wrongdoing. The same notice was also provided to OIG. The Board of WMGI also took a
number of measures to enhance WMTs compliance environment. WMT and the independent monitor
continue their investigative activities pursuant to the DPA, and communications between WMT, the
independent monitor, the USAO and OIG are ongoing.
WMT could receive a letter pursuant to Paragraph 50 of the DPA stating that the USAO believes that
WMT has knowingly and willfully breached one or more material provisions of the DPA. Pursuant to
the DPA WMT would have the opportunity to make a presentation within three weeks of receipt of such
a letter that could address whether any breach has occurred, whether any breach was knowing or
willful, materiality, and whether any breach has been cured.
- 2 -
Pursuant to the DPA, we expect that
the USAO would not take any further action until consideration of WMTs presentation.
The DPA and CIA impose certain obligations on WMT to maintain compliance with U.S. healthcare
regulatory laws. Our failure to do so could expose us to significant liability including, but not
limited to, extension of the term of the DPA by up to 6 months, exclusion from federal healthcare
program participation, including Medicaid and Medicare, which would have a material adverse effect
on our financial condition, results of operations and cash flows, potential prosecution, including
under the previously-filed criminal complaint, civil and criminal fines or penalties, and
additional litigation cost and expense. If not extended, our obligations under the DPA expire as of
September 29, 2011, while our obligations under the CIA expire as of September 29, 2015.
In addition to the USAO and OIG, other governmental agencies, including state authorities, could
conduct investigations or institute proceedings that are not precluded by the terms of the
settlements reflected by the DPA and the CIA. In addition, the settlement with the USAO and OIG
could increase our exposure to lawsuits by potential whistleblowers under the federal false claims
acts, based on new theories or allegations arising from the allegations made by the USAO. The costs
of defending or resolving any such investigations or proceedings could have a material adverse
effect on our financial condition, results of operations and cash flows.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
|
|
|
Exhibit No. |
|
Description |
99.1
|
|
Press release titled Wright Medical Group, Inc. Announces
Preliminary First Quarter Financial Results and Management Changes issued by the Company on May 4,2011. |
Cautionary Note Regarding Forward-Looking Statements:
This current report contains forward-looking statements as defined under U.S. federal
securities laws, including statements regarding potential actions by the USAO, independent monitor,
OIG and other agencies or their potential impact, and statements about expected financial results
for the quarter ended March 31, 201 1. These statements reflect managements current knowledge,
assumptions, beliefs, estimates, and expectations and express managements current views of future
performance, results, and trends and may be identified by their use of terms such as anticipate,
believe, could, estimate, expect, intend, may, plan, predict, project, will,
and other similar terms. Forward-looking statements are subject to a number of risks and
uncertainties that could cause our actual results to materially differ from those described in the
forward-looking statements. Readers should not place undue reliance on forward looking statements.
Such statements are made as of the date of this Current Report on Form 8-K, and we undertake no
obligation to update such statements after this date. Risks and uncertainties that could cause our
actual results to materially differ from those described in forward-looking statements include
those discussed in our filings with the Securities and Exchange Commission (including those
described in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2010,
under the heading, Risk Factors and elsewhere), and the impact of our settlement of the federal
investigation into our consulting arrangements with orthopaedic surgeons relating to our hip and
knee products in the United States, including our compliance with the Deferred Prosecution
Agreement through September 2011 (which could, by its terms, be extended for a further six months)
and the Corporate
- 3 -
Integrity Agreement through September 2015, and any items identified during the
course of the Companys quarter-end accounting close processes. Our failure to comply with the
Deferred Prosecution Agreement or the Corporate Integrity Agreement could expose us to significant
liability including, but not limited to, extension of the term of the DPA by up to 6 months,
exclusion from federal healthcare program participation, including Medicaid and Medicare, which
would have a material adverse effect on our financial condition, results of operations and cash
flows, potential prosecution, including under the previously-filed criminal complaint, civil and
criminal fines or penalties, and additional litigation cost and expense. Readers should not place
undue reliance on forward-looking statements. Such statements are made as of the date of this press
release, and we undertake no obligation to update such statements after this date.
- 4 -
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
|
|
|
WRIGHT MEDICAL GROUP, INC.
|
|
Date: May 4, 2011 |
By: |
/s/ Lance A. Berry
|
|
|
|
Name: |
Lance A. Berry |
|
|
|
Title: |
Senior Vice President & Chief
Financial Officer |
|
|
- 5 -
EXHIBIT INDEX
|
|
|
Exhibit No. |
|
Description |
99.1
|
|
Press release titled Wright Medical Group,
Inc. Announces Preliminary First Quarter Financial Results and Management Changes issued by
the Company on May 4, 2011. |
- 6 -