-----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, Wwfw39Yu7v7FMMQFdMZPOCHdRIavig0tufzlAb3QBNRuewAow7io72o9q3RpqKsq YXipUQpemnosSttaCfPoAQ== 0001169232-07-001854.txt : 20070410 0001169232-07-001854.hdr.sgml : 20070410 20070410161541 ACCESSION NUMBER: 0001169232-07-001854 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070410 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070410 DATE AS OF CHANGE: 20070410 FILER: COMPANY DATA: COMPANY CONFORMED NAME: E-Z-EM, Inc. CENTRAL INDEX KEY: 0000727008 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 111999504 STATE OF INCORPORATION: DE FISCAL YEAR END: 0531 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-13003 FILM NUMBER: 07759045 BUSINESS ADDRESS: STREET 1: 1111 MARCUS AVENUE STREET 2: SUITE LL-26 CITY: LAKE SUCCESS STATE: NY ZIP: 11042 BUSINESS PHONE: 5163338230 MAIL ADDRESS: STREET 1: 1111 MARCUS AVENUE STREET 2: SUITE LL-26 CITY: LAKE SUCCESS STATE: NY ZIP: 11042 FORMER COMPANY: FORMER CONFORMED NAME: EZ EM INC DATE OF NAME CHANGE: 19920703 8-K 1 d71543_8k.htm CURRENT REPORT

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): April 10, 2007  

 

 

 

E-Z-EM, Inc.

 

 

(Exact name of registrant as specified in its charter)

 

 

 

 

Delaware

 

 

(State or other jurisdiction of incorporation)

 

 

 

 

0-13003

 

11-1999504

 

 

(Commission File Number)

 

(IRS Employer Identification No.)

 

 

 

 

1111 Marcus Avenue, Lake Success, New York

 

11042

 

 

(Address of principal executive offices)

 

(Zip Code)

 

 

 

 

(516) 333-8230

 

 

(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

 

Item 7.01

Regulation FD Disclosure

 

The following information is furnished pursuant to both Item 2.02 and Item 7.01:

 

On April 10, 2007, E-Z-EM, Inc. issued a press release announcing its financial results for the quarter and nine months ended March 3, 2007. A copy of the release is attached hereto as Exhibit 99.1 and is incorporated herein by reference in its entirety.

 

Item 9.01

Financial Statements and Exhibits

 

 

(c)

Exhibits

 

 

99.1

Press release issued by E-Z-EM, Inc. on April 10, 2007 announcing its financial results for the quarter and nine months ended March 3, 2007.

 

 

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SIGNATURES

 

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.

 

 

 

 

 

E-Z-EM, Inc.

 

 

 

(Registrant)

 

 

 

 

 

 

 

 

 

 

Dated:

April 10, 2007

 

By:

/s/ Joseph A. Cacchioli

 

 

 

 

Joseph A. Cacchioli

 

 

 

 

Vice President – Controller

 

 

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EXHIBIT INDEX

 

No.

Description

 

 

 

- 4 -

 

 

EX-99.1 2 d71543_ex99-1.htm PRESS RELEASE

Exhibit 99.1

 

Company Contact:

Investor Relations Contacts:

E-Z-EM, Inc.

Lippert/Heilshorn & Associates, Inc.

Tom Johnson x3317

Anne Marie Fields ( afields@lhai.com )

(800) 544-4624

(212) 838-3777

www.ezem.com

Bruce Voss ( bvoss@lhai.com )

 

(310) 691-7100

 

www.lhai.com

FOR IMMEDIATE RELEASE

 

E-Z-EM REPORTS THIRD QUARTER FISCAL 2007 FINANCIAL RESULTS

 

Adjusts 2007 Net Sales Guidance, Affirms Earnings Guidance

 

Conference Call Begins at 4:30 p.m. Eastern Time

 

LAKE SUCCESS, N.Y. (April 10, 2007) – E-Z-EM, Inc. (NASDAQ: EZEM) today announced financial results for the third quarter of fiscal year 2007, ended March 3, 2007. Highlights of the quarter and recent weeks include:

 

 

Net sales from continuing operations of $33.6 million

 

Earnings from continuing operations of $2.2 million, or $0.20 per diluted share

 

CT imaging product sales up 14.4%

 

Milestone C approval for RSDL™ from U.S. Department of Defense (DoD)

 

Placement of DoD procurement order for RSDL

 

Net sales from continuing operations were $33.6 million for the quarter ended March 3, 2007, up 4.6% over net sales from continuing operations of $32.1 million for the quarter ended March 4, 2006. Growth in CT imaging products contributed to increased sales in the quarter, but was partially offset by lower sales in contract manufacturing.

 

Gross profit for the third quarter of 2007 was $14.2 million, an 11.8% increase from $12.7 million for the year-ago quarter. Gross profit as a percentage of sales improved to 42.3% for the current quarter from 39.6% for the third quarter of 2006 due to sales price increases and favorable changes in product mix.

 

Operating expenses were $11.4 million for the fiscal 2007 third quarter, compared with $10.2 million for the prior-year quarter. The current quarter included increased costs associated with the expansion of the Company’s North American sales force, offset by lower research and development (R&D) costs resulting from the termination of an R&D cost-sharing project. Operating expenses in the prior-year quarter reflect the recognition of a $1.2 million gain from the sale of the Company’s Westbury, N.Y. manufacturing facility. Operating profit was $2.8 million for the third quarter of fiscal year 2007, compared with $2.5 million for the comparable prior-year quarter.

 

For the quarter ended March 3, 2007, the Company’s effective tax rate of 31% differed from the Federal statutory rate of 34% primarily due to increased tax-exempt income, partially offset by non-deductible expenses. For the quarter ended March 4, 2006, the Company’s effective tax rate of 14% differed from the Federal rate of 34% due primarily to the reversal of a valuation allowance of $0.5 million relating to a previously impaired, non-core equity security.

 

- 5 -

 



Earnings from continuing operations for the fiscal 2007 third quarter were $2.2 million, or $0.20 per diluted share, compared with earnings from continuing operations of $2.4 million, or $0.21 per diluted share, for the prior-year quarter, which included $1.2 million or $0.07 per diluted share from the gain on the sale of the manufacturing facility and $0.5 million or $0.04 per diluted share from the tax valuation reversal.

 

For the nine months (39 weeks) ended March 3, 2007, net sales from continuing operations were $101.2 million, compared with net sales from continuing operations of $100.3 million for the nine months (40 weeks) ended March 4, 2006. The first nine months of fiscal year 2006 benefited from an additional selling week, as well as approximately $1.6 million in backlog sales resulting from the recall in December 2004 by Mallinckrodt of its liquid barium products. Gross profit was $44.1 million for the first nine months of fiscal 2007 versus $43.5 million for the comparable prior-year period, and as a percentage of sales was 43.5% compared with 43.4% for the prior-year period. Operating profit was $7.1 million, compared with $9.0 million reported last year. Earnings from continuing operations for the first nine months of fiscal 2007 were $5.8 million, or $0.52 per diluted share, compared with $6.5 million, or $0.58 per diluted share, for the comparable period last year, which included $1.2 million or $0.07 per diluted share from the gain on the sale of the manufacturing facility and $0.5 million or $0.04 per diluted share from the tax valuation reversal.

 

E-Z-EM had cash, cash equivalents and short-term debt and equity securities as of March 3, 2007 of $42.7 million, compared with $40.2 million as of June 3, 2006. Working capital was $82.4 million as of March 3, 2007, compared with $77.1 million as of the previous fiscal year-end.

 

Commenting on the results, Anthony A. Lombardo, president and CEO of E-Z-EM, said, “Results for the third quarter showed growth in key product areas, though not at levels we anticipated earlier in the year. Accordingly, we are reducing our fiscal year 2007 net sales guidance to approximately $141 million; our original earnings guidance of at least $7.4 million or $0.66 per diluted share remains unchanged. The reduced net sales guidance is primarily attributable to lower-than-expected sales in CT imaging and RSDL products, and regulatory delays associated with E-Z CHEM™ and EmpowerMR™.

 

“Net sales for the current quarter were up 4.6% over last year’s period, led by our CT imaging products, which collectively grew 14.4% over the prior-year quarter. Within CT imaging products, sales growth was led by our oral CT contrast products, which were up 12.2% over the prior-year period. Empower injector systems grew 17.3% overall, and 37.2% internationally. CT syringe sales were up 21.9%, a reflection of our strong installed-base and overall growth in CT imaging procedures. Virtual colonoscopy products, though still not a major contributor in dollar terms, grew 38.3% over the prior-year quarter.

 

“We believe that CT imaging growth in the quarter may have been hindered by the Deficit Reduction Act of 2005 (DRA), which took effect on January 1, 2007. Within radiology, the DRA effectively reduces the Medicare and Medicaid reimbursement rates for MR, CT and PET/CT procedures performed at outpatient imaging centers. The impact of DRA is now just being felt in the market and remains to be quantified. Some of our customers have delayed plans to purchase imaging equipment, at least in the near term, in order to assess the impact of DRA on their businesses. We believe that this may have reduced third quarter sales of our CT injector systems. We will, of course, be monitoring developments in this area closely.

 

“Following the close of our third quarter, the DoD issued its Milestone C approval decision for RSDL, and subsequently placed its first procurement order for the product. We expect to ship a portion of this order by the end of our current fiscal year, and believe this order is the first of what will be an ongoing procurement program designed to establish RSDL as the preferred personal skin decontaminant for U.S. war-fighters. Additional purchases from DoD are subject to the Federal budgeting and approval process. This is obviously a major development for our RSDL business and for our Company.”

 

- 6 -

 



Fiscal Year 2007 Financial Guidance

 

The Company is revising its net sales guidance for fiscal 2007 and now expects net sales for the year to be approximately $141 million, compared with previous net sales guidance of at least $147 million. The Company affirms its net earnings guidance of at least $7.4 million, or $0.66 per diluted share.

 

Conference Call

 

E-Z-EM management will host an investment conference call to discuss fiscal 2007 third quarter results today beginning at 4:30 p.m. Eastern time. To participate, please dial (877) 815-7177 from the U.S. or (706) 679-0753 from outside the U.S. In addition, a telephone replay of the call will be accessible for a limited time following completion of the call by dialing (800) 642-1687 or (706) 645-9291, and entering reservation number 4739224. Participants can access the call over the Internet by visiting www.ezem.com , and the call will be archived there for a limited period of time.

 

About E-Z-EM, Inc.

 

E-Z-EM is a leading manufacturer of contrast agents for gastrointestinal radiology. The Company is the developer of VoLumen® the next generation low density barium sulfate suspension for use as an oral contrast in Multidetector CT (MDCT) and Positron Emission Tomography (PET/CT) studies. The Company also offers Empower®—the only family of CT injectors on the market with patented EDA™ technology that can help detect contrast extravasation—and offers a complete product set for the virtual colonoscopy practitioner. This product line consists of virtual colonoscopy hardware, software, nutritional prep kits and bowel cleaners, tagging agents and a carbon dioxide colon insufflation system. The Company is also the exclusive global manufacturer and marketer of RSDL for military services and first-responder organizations. RSDL is a liquid skin decontaminant that breaks down chemical agents such as Sarin or VX in seconds, leaving a non-toxic liquid that can be washed away with water.

 

The statements made in this document contain certain forward-looking statements. Words such as “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates” or variations of such words and similar expressions, are intended to identify such forward-looking statements. The forward-looking statements contained in this release may involve numerous risks and uncertainties, known and unknown, beyond the Company’s control. Such risks and uncertainties include: the ability of the Company to develop its products; continued growth in CT product sales; continued growth in VC product sales; Federal approval for reimbursement for virtual colonoscopy screening exams; market acceptance and sales of RSDL, placement of further DoD orders for RSDL, the timing and impact of the DoD order for RSDL on the Company’s fourth fiscal quarter of 2007; continued market acceptance and sales of VoLumen®; the effects of the 2007 Medicare and Medicaid reimbursement rates and the implementation of the Deficit Reduction Act of 2005; future actions by the FDA or other regulatory agencies, overall economic conditions, general market conditions, price increases of raw materials and components, foreign currency exchange rate fluctuations as well as the risk factors listed from time to time in the SEC filings of E-Z-EM, Inc., including but not limited to its Form 10-Q for the quarter ended December 2, 2006 and its Annual Report on Form 10-K for the fiscal year ended June 3, 2006. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements, and investors are cautioned not to place undue reliance on the forward-looking statements included in this release.

 

(Tables to follow)

 

 

- 7 -

 



E-Z-EM, Inc. and Subsidiaries

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

(in thousands)

 

March 3,
2007

June 3,
2006*

                 
Assets                
                 
Current assets                
     Cash, cash equivalents and debt and equity securities     $ 42,725   $ 40,195  
     Accounts receivable, net       23,436     20,680  
     Inventories, net       27,108     27,028  
     Other current assets       5,695     7,052  
     Current assets of discontinued operation             426  


                 
Total current assets       98,964     95,381  
                 
Property, plant and equipment, net       14,536     12,445  
Other non-current assets       14,006     15,361  
Non-current assets of discontinued operation             605  


                 
Total assets     $ 127,506   $ 123,792  


                 
                 
Liabilities and Stockholders’ Equity                
                 
Current liabilities                
     Accounts payable     $ 6,933   $ 5,702  
     Accrued liabilities       9,027     12,123  
     Other current liabilities       603     78  
     Current liabilities of discontinued operation             417  


                 
Total current liabilities       16,563     18,320  
                 
Non-current liabilities       3,669     3,630  
Stockholders’ equity       107,274     101,842  


                 
Total liabilities and stockholders’ equity     $ 127,506   $ 123,792  


 

* Reclassified to reflect the discontinued operation associated with the closing of the Company’s Japanese subsidiary.

 

 

- 8 -

 



E-Z-EM, Inc. and Subsidiaries

CONDENSED CONSOLIDATED STATEMENTS OF EARNINGS

(unaudited)

(in thousands, except per share data)

 

Thirteen weeks ended
Thirty-nine
weeks ended
Forty
weeks ended
March 3,
2007

March 4,
2006*

March 3,
2007

March 4,
2006*

                             
Net sales     $ 33,558   $ 32,096   $ 101,169   $ 100,276  
Cost of goods sold       19,372     19,390     57,103     56,767  




                             
          Gross profit       14,186     12,706     44,066     43,509  




                             
Operating expenses    
     Selling, general and administrative       10,548     9,919     33,126     31,333  
     Plant closing and operational restructuring                            
          costs (credits)             (39 )         96  
     Gain on sale of real property             (1,205 )         (1,205 )
     Research and development       888     1,562     3,823     4,314  




                             
     Total operating expenses       11,436     10,237     36,949     34,538  




                             
          Operating profit       2,750     2,469     7,117     8,971  
                             
Other income (expense), net       418     285     1,486     44  




                             
          Earnings from continuing operations                            
               before income taxes       3,168     2,754     8,603     9,015  
                             
Income tax provision       985     389     2,819     2,553  




                             
          Earnings from continuing operations       2,183     2,365     5,784     6,462  
                             
Earnings (loss) from discontinued operation,                            
     net of income tax provision (benefit)       216     1,977     (19 )   1,958  




                             
          Net earnings     $ 2,399   $ 4,342   $ 5,765   $ 8,420  




                             
Basic earnings (loss) per common share                            
     From continuing operations     $ 0.20   $ 0.22   $ 0.53   $ 0.60  
     From discontinued operation, net of                            
          income tax provision (benefit)       0.02     0.18           0.18  




                             
     From total operations     $ 0.22   $ 0.40   $ 0.53   $ 0.78  




                             
Diluted earnings (loss) per common share                            
     From continuing operations     $ 0.20   $ 0.21   $ 0.52   $ 0.58  
     From discontinued operation, net of                            
          income tax provision (benefit)       0.02     0.18           0.18  




                             
     From total operations     $ 0.22   $ 0.39   $ 0.52   $ 0.76  




                             
Weighted average common shares                            
     Basic       10,964     10,855     10,908     10,846  
     Diluted       11,184     11,190     11,110     11,100  

 

* Reclassified to reflect the discontinued operation associated with the closing of the Company’s Japanese subsidiary.

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