-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, KokfwZIvJ9wWAoGYerdO1KE1pXZmvf2ABi4qdTDPNmavCHCrRlLdzRGNcCvuIPK2 FAt8CchTsy61YzMN0+xagg== 0000950134-08-008268.txt : 20080502 0000950134-08-008268.hdr.sgml : 20080502 20080502080016 ACCESSION NUMBER: 0000950134-08-008268 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080502 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080502 DATE AS OF CHANGE: 20080502 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ev3 Inc. CENTRAL INDEX KEY: 0001318310 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 320138874 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-51348 FILM NUMBER: 08796670 BUSINESS ADDRESS: STREET 1: 9600 54TH AVENUE NORTH STREET 2: SUITE 100 CITY: PLYMOUTH STATE: MN ZIP: 55442-2111 BUSINESS PHONE: (763) 398-7000 MAIL ADDRESS: STREET 1: 9600 54TH AVENUE NORTH STREET 2: SUITE 100 CITY: PLYMOUTH STATE: MN ZIP: 55442-2111 8-K 1 c26362e8vk.htm CURRENT REPORT 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 2, 2008
 
ev3 Inc.
(Exact name of registrant as specified in its charter)
         
Delaware   000-51348   32-0138874
(State or Other Jurisdiction of   (Commission File Number)   (I.R.S. Employer Identification
Incorporation)       Number)
     
9600 54th Avenue North, Suite 100
Plymouth, Minnesota
  55442
(Address of Principal Executive Offices)   (Zip Code)
(763) 398-7000
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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 2, 2008, ev3 Inc. issued a press release announcing its financial results for its fiscal first quarter ended March 30, 2008. A copy of this press release is furnished as Exhibit 99.1 and is incorporated herein by reference.
     The information contained in this report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, and shall not be incorporated by reference into any filings made by ev3 Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as may be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
     (c) Exhibits.
     
Exhibit No.   Description
99.1
  Press Release issued May 2, 2008

 


 

SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
Dated: May 2, 2008   ev3 Inc.
 
 
  By:   /s/ Kevin M. Klemz    
    Name:   Kevin M. Klemz   
    Title:   Senior Vice President, Secretary and Chief Legal Officer   
 

 


 

ev3 Inc.
CURRENT REPORT ON FORM 8-K

EXHIBIT INDEX
         
Exhibit No.   Description   Method of Filing
99.1
  Press Release issued May 2, 2008   Furnished herewith

 

EX-99.1 2 c26362exv99w1.htm PRESS RELEASE exv99w1
 

Exhibit 99.1

(EV3 LOGO)
CONTACT INFORMATION:
INVESTORS and MEDIA:
Julie Tracy
Sr. Vice President, Chief Communications Officer
ev3 Inc.
(949) 680-1375
jtracy@ev3.net


ev3 Inc. Reports 2008 First Quarter Financial Results
and Revised 2008 Guidance
PLYMOUTH, Minn. — May 2, 2008 — ev3 Inc. (NASDAQ: EVVV), a global endovascular device company, today reported financial results for its fiscal first quarter of 2008 and its revised financial guidance for 2008.
As previously reported, ev3’s net sales were $101.3 million in the first quarter of 2008 representing a 65% increase over the same quarter of the prior year and a 10% increase over the fourth quarter of 2007. The increase in net sales over the same quarter of the prior year was primarily attributable to the acquisition of FoxHollow. The sequential quarter increase in net sales was driven by growth in the pre-FoxHollow acquisition peripheral vascular business segment and the neurovascular business segment. However, first quarter net sales results were negatively impacted by greater than anticipated sales force integration challenges related to the FoxHollow acquisition and elevated customer inventory levels of SilverHawk products.
Robert Palmisano, president and chief executive officer of ev3 Inc., commented, “While we believe that our fundamental strategies are sound, we have much work ahead of us to improve our execution and efficiency. My top priority will be to continue expanding our position in the peripheral vascular and neurovascular markets globally by offering a full complement of innovative therapies, investing in the development of our next generation of products and pursuing a broad clinical trial agenda to bring new products to market and further validate the scientific foundation of our endovascular procedures. I believe these initiatives will in turn drive growth and shareholder value.”
Palmisano commented further, “In resetting our guidance, we took into account the factors that could affect our business in 2008, including the performance of our U.S. atherectomy business, which continues to be adversely affected by elevated customer inventory levels of SilverHawk, the ability of our U.S. peripheral vascular sales organization to take advantage of cross-selling opportunities, and the effect of competition and new competitive entrants into the marketplace. I am confident that this guidance is appropriate for our business and achievable.”
ev3’s net loss for the first quarter of 2008 increased 3% to $9.8 million compared to $9.5 million in the first quarter of 2007. ev3’s net loss per common share was $0.09 for the first quarter of 2008 compared to $0.17 in the first quarter of 2007. Total weighted average common shares outstanding used in the per share calculations were 104.1 million and 57.5 million for the first quarter of 2008 and 2007, respectively.

 


 

ev3’s earnings before interest, taxes, depreciation and amortization (EBITDA), excluding charges for non-cash stock-based compensation, was a positive $6.2 million in the first quarter of 2008, compared to a negative $1.2 million in the first quarter of 2007. ev3 uses the non-GAAP financial measure, EBITDA, excluding charges for non-cash stock-based compensation, and certain other non-GAAP financial measures, as supplemental measures of performance and believe that these measures facilitate operating performance comparisons from period to period and company to company. EBITDA, excluding charges for non-cash stock-based compensation, for the first quarter of 2008 and 2007 are reconciled to ev3’s net loss for the respective periods immediately following the detail of net sales by geography later in this press release.
Palmisano concluded, “Throughout 2008, we will continue to focus on expanding our channel to endovascular specialists worldwide, driving global procedure penetration and expanding our portfolio of therapy solutions to treat peripheral vascular and neurovascular disease. We also will focus on improving execution and operational efficiency to drive results for our customers and shareholders. I am confident that we will be able to capitalize on the market opportunities and work towards building a leading global endovascular organization.”
Sales Review
Peripheral vascular segment net sales in the first quarter of 2008 increased 76% to $64.1 million versus $36.5 million in the first quarter of 2007 primarily as a result of our FoxHollow acquisition, and to a lesser extent, increased market penetration of the EverFlex stent. Excluding atherectomy revenue of $22.7 million, peripheral vascular sales increased 13% to $41.4 million in the first quarter of 2008 versus $36.5 million in the first quarter of 2007. Stent product sales increased 21% to $24.0 million from $19.8 million. Thrombectomy and embolic protection product sales decreased slightly to $6.0 million from $6.2 million, while sales of procedural support and other peripheral vascular products increased 9% to $11.4 million from $10.5 million.
In the first quarter of 2008, ev3’s neurovascular segment net sales increased 24% to $31.0 million versus $25.0 million in the first quarter of 2007. Within the neurovascular business segment, sales of embolic products increased 38% to $17.9 million from $12.9 million, and sales of neurovascular access and delivery products were up 8% to $13.1 million from $12.1 million. The primary growth drivers for the neurovascular segment were the Axium coil and the continued market penetration of the Onyx Liquid Embolic System for the treatment of brain arterio-venous malformations (AVMs).
Research collaboration revenue resulting from our agreement with Merck & Co., Inc. was $6.2 million for the first quarter of 2008.
On a geographic basis, when compared to the first quarter of 2007, ev3’s first quarter 2008 U.S. net sales increased 89% to $66.5 million, while first quarter 2008 international net sales increased 32% to $34.8 million, over the prior-year quarter. ev3’s first quarter 2008 U.S. net sales increase was primarily due to our FoxHollow acquisition. International sales growth was primarily due to further market penetration of the EverFlex family of stents and the launch of the Axium coil. Changes in foreign currency exchange rates had a positive impact of approximately $2.6 million on first quarter 2008 net sales compared to the first quarter of the prior year.

 


 

Outlook
ev3 has updated its expected fiscal year 2008 net sales guidance to be in the range of $425 to $430 million consisting of $400 to $405 million of product net sales and $25 million of research collaboration revenue and earnings per share, as adjusted to be in the range of $0.00 to $0.05 per diluted share based on approximately 104 million of outstanding shares. Earnings per share, as adjusted does not include pre-tax charges for amortization expense of approximately $33.0 million and non-cash stock-based compensation of approximately $19.0 million.
The company expects second quarter 2008 net sales to be in the range of $101 to $103 million consisting of $95 to $97 million of product net sales and $6 million of research collaboration revenue and net loss per share, as adjusted to be in the range of $0.06 to $0.09 per diluted share based on approximately 104 million of outstanding shares. Net loss per share, as adjusted does not include pre-tax charges for amortization expense of approximately $8.3 million and non-cash stock-based compensation of approximately $6.0 million.
ev3’s cash and short-term investments balance at March 30, 2008 was $57.0 million. The company has an existing undrawn credit facility and believes that this credit facility, along with its existing cash and short-term investments, will provide sufficient liquidity and financial flexibility to meet the company’s anticipated operating and strategic needs for the foreseeable future.
Earnings Call Information
ev3 will host a conference call today, May 2, 2008, beginning at 7:30 a.m. CT (8:30 a.m. ET) to review its results of operations for the first quarter of 2008 and future outlook, followed by a question and answer session.
The conference call will be available to interested parties through a live audio webcast at www.ev3.net, where it will be archived and accessible for approximately 90 days. The live dial-in number for the call is 888-679-8035 (U.S.) or 617-213-4848 (International). The participant passcode is 66432499.
If you do not have access to the Internet and want to listen to an audio replay of the conference call, dial 888-286-8010 (U.S.) or 617-801-6888 (International) and enter passcode 31387240. The audio replay will be available beginning at 9:30 a.m. CT on Friday, May 2, 2008 until Friday, May 9, 2008.
About ev3 Inc.
Since its founding in 2000, ev3 has been dedicated to improving the lives of patients with vascular disease through the development of innovative endovascular therapies. ev3’s products are used by endovascular specialists to treat a wide range of peripheral vascular and neurovascular diseases and disorders. The company offers a comprehensive portfolio of treatment options, including the primary interventional technologies used today — peripheral angioplasty balloons, stents, plaque excision systems, embolic protection devices, liquid embolics, embolization coils, thrombectomy catheters and occlusion balloons. More information about the company and its products can be found at www.ev3.net.

 


 

ev3, the ev3 logo, Axium, Onyx, EverFlex, FoxHollow and SilverHawk are trademarks of ev3 Inc., registered in the U.S. and other countries. All trademarks and trade names referred to in this press release are the property of their respective owners.
Forward-Looking Statements
Statements contained in this press release that are not historical information are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results and liquidity needs, anticipated revenue synergies and cost savings as a result of ev3’s acquisition of FoxHollow and the timing thereof, anticipated expenses as a result of ev3’s acquisition of FoxHollow and the timing thereof, effects of recent U.S. peripheral vascular sales force restructuring activities, new product benefits and market acceptance, and other statements identified by words such as “expect,” “anticipate,” “will,” “may,” “believe,” “could,” “outlook,” “guidance,” or words of similar meaning and any other statements that are not historical facts. Such forward-looking statements are based upon the current beliefs and expectations of ev3’s management and are inherently subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied. Such potential risks and uncertainties include, but are not limited to, in no particular order: the failure to achieve profitability within expected time periods, the failure to realize revenue synergies and cost-savings from ev3’s acquisition of FoxHollow, the closure of its Redwood City facility or delay in realization thereof; the businesses of ev3 and FoxHollow not being integrated successfully, or such integration taking longer or being more difficult, time-consuming or costly to accomplish than expected; the impact of competitive products and pricing; changes in the regulatory environment; availability of third party reimbursement; potential margin pressure resulting from volume selling, as well as potential adverse effects on future product demand resulting from volume purchases; delays in regulatory approvals and the introduction of new products; market acceptance of new products and success of clinical testing. More detailed information on these and additional factors which could affect ev3’s operating and financial results is described in the company’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K. ev3 Inc. urges all interested parties to read this report to gain a better understanding of the many business and other risks that the company faces. Additionally, ev3 undertakes no obligation to publicly release the results of any revisions to these forward-looking statements, which may be made to reflect events or circumstances occurring after the date hereof or to reflect the occurrence of unanticipated events.
Use of Non-GAAP Financial Measures
In addition to financial measures prepared in accordance with generally accepted accounting principles (GAAP), ev3 uses certain non-GAAP financial measures. In this release, ev3 uses the

 


 

non-GAAP financial measures, “EBITDA, excluding charges for non-cash stock-based compensation,” “peripheral vascular sales, excluding atherectomy revenues” and “adjusted earnings (loss) per share.” ev3 uses non-GAAP financial measures as supplemental measures of performance and believes these measures facilitate operating performance comparisons from period to period and company to company by factoring out potential differences caused by acquisitions, non-recurring, unusual or infrequent charges not related to ev3’s regular, ongoing business, variations in capital structure, tax positions, depreciation, non-cash charges and certain large and unpredictable charges. ev3 also believes that the presentation of certain non-GAAP financial measures provide useful information to investors in evaluating the company’s operations, period over period. Non-GAAP measures have limitations as analytical tools, and should not be considered in isolation, or as a substitute for analysis of the company’s results as reported under GAAP. When analyzing ev3’s operating performance, investors should not consider ev3’s EBITDA, excluding charges for non-cash stock-based compensation, ev3’s peripheral vascular net sales, excluding atherectomy revenues, or ev3’s adjusted earnings (loss) per share as substitutes for ev3’s net income (loss), ev3’s peripheral vascular net sales or ev3’s net income (loss) per share, respectively, each as prepared in accordance with GAAP. In addition, investors should note that any non-GAAP financial measures used by ev3 may not be the same non-GAAP financial measures, and may not be calculated in the same manner, as that of other companies. Whenever ev3 uses historical non-GAAP financial measures, it provides a reconciliation of the non-GAAP financial measure to the most closely applicable GAAP financial measure. Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measure. A reconciliation of ev3’s EBITDA, excluding charges for non-cash stock-based compensation, to ev3’s net loss prepared in accordance with GAAP can be found immediately following the detail of net sales by geography later in this press release. This information is also made available on the company’s website at www.ev3.net. ev3, however, does not provide forward-looking guidance for certain financial data, such as depreciation, accretion, net income (loss), net income (loss) per common share and as a result, is not able to provide a reconciliation of GAAP to non-GAAP financial measures for forward-looking data. In particular, ev3 is providing adjusted earnings (loss) per share guidance in this release only on a non-GAAP basis due to the inherent uncertainties associated with forecasting the timing and amount of restructuring, impairment and other unusual and infrequent items associated with its acquisition of FoxHollow.

 


 

ev3 Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS

(Dollars in thousands, except per share amounts)
(unaudited)
                 
    For the Three Months Ended  
    March 30,     April 1,  
    2008     2007  
Sales
               
Product sales
  $ 95,050     $ 61,499  
Research collaboration
    6,207        
 
           
Net sales
    101,257       61,499  
 
               
Operating expenses
               
Product cost of goods sold (a)
    31,970       20,457  
Research collaboration
    1,648        
Sales, general and administrative (a)
    59,828       39,137  
Research and development (a)
    11,726       7,433  
Amortization of intangible assets
    8,243       4,100  
Loss on sale or disposal of assets, net
          16  
 
           
Total operating expenses
    113,415       71,143  
 
               
Loss from operations
    (12,158 )     (9,644 )
 
               
Other income:
               
Interest income, net
    (441 )     (109 )
Other income, net
    (2,432 )     (317 )
 
           
Loss before income taxes
    (9,285 )     (9,218 )
 
               
Income tax expense
    485       276  
 
           
 
Net loss
  $ (9,770 )   $ (9,494 )
 
           
 
               
Earnings per share:
               
Net loss per common share (basic and diluted)
  $ (0.09 )   $ (0.17 )
 
           
 
               
Weighted average common shares outstanding
    104,094,790       57,514,255  
 
           
 
               
 
(a) Includes stock-based compensation charges of:
               
Cost of goods sold
  $ 297     $ 158  
Sales, general and administrative
    3,594       1,859  
Research and development
    840       182  
 
           
 
  $ 4,731     $ 2,199  
 
           

 


 

ev3 Inc.
CONSOLIDATED BALANCE SHEETS

(Dollars in thousands, except per share amounts)
                 
    March 30,     December 31,  
    2008     2007  
    (unaudited)          
Assets
               
Current assets
               
Cash and cash equivalents
  $ 49,300     $ 81,060  
Short-term investments
    7,700       9,744  
Accounts receivable, less allowance of $8,017 and $6,783, respectively
    77,933       66,170  
Inventories
    66,579       64,044  
Prepaid expenses and other assets
    5,603       6,371  
Other receivables
    1,595       981  
 
           
Total current assets
    208,710       228,370  
 
Restricted cash
    2,194       2,204  
Property and equipment, net
    38,086       37,985  
Goodwill
    591,438       586,648  
Other intangible assets, net
    223,336       231,000  
Other assets
    637       899  
 
           
Total assets
  $ 1,064,401     $ 1,087,106  
 
           
 
Liabilities and stockholders’ equity
               
Current liabilities
               
Accounts payable
  $ 16,303     $ 21,511  
Accrued compensation and benefits
    29,430       35,301  
Accrued liabilities
    46,900       49,429  
Deferred revenue
    4,715       9,347  
Current portion of long-term debt
    3,571       3,571  
 
           
Total current liabilities
    100,919       119,159  
 
Long-term obligations
    5,536       6,429  
Other long-term liabilities
    3,719       3,037  
 
           
Total liabilities
    110,174       128,625  
 
               
Stockholders’ equity
               
 
               
Common stock, $0.01 par value; 300,000,000 shares authorized; shares issued and outstanding: 105,403,600 shares at March 30, 2008 and 105,078,769 shares at December 31, 2007
    1,054       1,051  
Additional paid in capital
    1,745,105       1,739,064  
Accumulated deficit
    (790,809 )     (781,039 )
Accumulated other comprehensive loss
    (1,123 )     (595 )
 
           
Total stockholders’ equity
    954,227       958,481  
 
           
Total liabilities and stockholders’ equity
  $ 1,064,401     $ 1,087,106  
 
           

 


 

ev3 Inc.
SELECTED NET SALES INFORMATION

(Dollars in thousands, except per share amounts)
(unaudited)
                         
    For the Three Months Ended        
    March 30,     April 1,        
    2008     2007     % change  
NET SALES BY SEGMENT
                       
Peripheral Vascular
                       
Atherectomy
  $ 22,700     $     NA  
Stents
    24,032       19,806       21 %
Thrombectomy and embolic protection
    5,955       6,218       -4 %
Procedural support and other
    11,426       10,467       9 %
 
                 
Total peripheral vascular
    64,113       36,491       76 %
 
                       
Neurovascular
                       
Embolic products
    17,864       12,926       38 %
Neuro access and delivery products
    13,073       12,082       8 %
 
                 
Total neurovascular
    30,937       25,008       24 %
 
                       
Research collaboration
    6,207           NA  
 
                 
 
                       
Total company
  $ 101,257     $ 61,499       65 %
 
                 
                         
    For the Three Months Ended        
    March 30,     April 1,        
    2008     2007     % change  
NET SALES BY GEOGRAPHY
                       
United States
  $ 66,452     $ 35,140       89 %
International
    34,805       26,359       32 %
 
                 
 
Total net sales
  $ 101,257     $ 61,499       65 %
 
                 

 


 

ev3 Inc.
NON-GAAP FINANCIAL MEASURES

(Dollars in thousands)
(unaudited)
                 
    For the Three Months Ended  
    March 30,     April 1,  
    2008     2007  
Reconciliation of net loss to EBITDA
               
 
               
Net loss, as reported (GAAP basis)
  $ (9,770 )   $ (9,494 )
 
               
Interest income, net
    (441 )     (109 )
Income tax expense
    485       276  
Depreciation and amortization
    11,176       5,904  
 
           
 
EBITDA
  $ 1,450     $ (3,423 )
 
               
Stock-based compensation
    4,731       2,199  
 
 
           
EBITDA, adjusted for stock-based compensation
  $ 6,181     $ (1,224 )
 
           
###

 

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