-----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, MlNEXokEXVp8yLej+Zi32aRuSJIM3uCTLiiA8Z/0TBG2TY5RlgM4LXspqyZOPHZn JF2a6Ubxjn/bOz2EfmRDNw== 0000950134-07-017181.txt : 20070807 0000950134-07-017181.hdr.sgml : 20070807 20070807163109 ACCESSION NUMBER: 0000950134-07-017181 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070807 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070807 DATE AS OF CHANGE: 20070807 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CEPHEID CENTRAL INDEX KEY: 0001037760 STANDARD INDUSTRIAL CLASSIFICATION: LABORATORY ANALYTICAL INSTRUMENTS [3826] IRS NUMBER: 770441625 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-30755 FILM NUMBER: 071031980 BUSINESS ADDRESS: STREET 1: 1190 BORREGAS AVE CITY: SUNNYVALE STATE: CA ZIP: 94089 BUSINESS PHONE: 4085414191 MAIL ADDRESS: STREET 1: 1190 BORREGAS CITY: SUNNYVALE STATE: CA ZIP: 94089 8-K 1 f32757e8vk.htm FORM 8-K e8vk
Table of Contents

 
 
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): August 7, 2007
CEPHEID
(Exact name of Registrant as specified in its charter)
         
California
(State or other jurisdiction of
incorporation)
  000-0030755
(Commission file number)
  77-0441625
(I.R.S. Employer Identification
No.)
904 Caribbean Drive, Sunnyvale, CA            94089
(Address of principal executive offices)            (Zip Code)
(408) 541-4191
(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 (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))
 
 

 


TABLE OF CONTENTS

Item 2.02      Results of Operations and Financial Condition.
Item 9.01      Financial Statements and Exhibits.
SIGNATURES
Exhibit Index
EXHIBIT 99.01


Table of Contents

Item 2.02      Results of Operations and Financial Condition.
     The information in this report and the exhibit attached hereto are being furnished pursuant to Item 2.02 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall they be deemed incorporated by reference in any filing with the Securities and Exchange Commission under the Securities Act of 1934 or the Securities Act of 1933, except as shall be expressly set forth by specific reference to such filing.
     On August 7, 2007, Cepheid issued a press release announcing its financial results for the quarter ended June 30, 2007 and certain other information. The press release is attached to this report as Exhibit 99.01.
Item 9.01      Financial Statements and Exhibits.
     
(d)
  Exhibits.
     
Exhibit No.   Exhibit Title
99.01
  Press released dated August 7, 2007.

 


Table of Contents

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.
         
  Cepheid
 
 
Date: August 7, 2007  By:   /s/ John L. Bishop    
    Name:   John L. Bishop   
    Title:   Chief Executive Officer   
 

 


Table of Contents

Exhibit Index
     
Exhibit No.   Exhibit Title
99.01
  Press release dated August 7, 2007.

 

EX-99.01 2 f32757exv99w01.htm EXHIBIT 99.01 exv99w01
 

Exhibit 99.1
(CEPHEID LETTERHEAD)
Cepheid Reports Second Quarter 2007 Results
SUNNYVALE, CALIF. — August 7, 2007—Cepheid (NASDAQ: CPHD) today announced financial results for the second quarter ended June 30, 2007. Key results for the second quarter 2007 include:
    Total revenues of $27.2 million, a 37 percent increase from $19.8 million in the second quarter of 2006.
 
    Clinical product sales of $10.6 million, a 165 percent increase from $4.0 million in the second quarter of 2006.
 
    Total product sales of $23.6 million, a 25 percent increase from $18.9 million in the second quarter of 2006.
 
    Gross margins on product sales of 42 percent compared to 39 percent in the second quarter of 2006 (both excluding stock compensation expense and the amortization of acquired intangibles).
 
    Net loss, excluding stock compensation expense and the amortization of acquired intangibles of $2.7 million, or $0.05 per share, compared to $5.1 million, or $0.09 per share, in the second quarter 2006.
Total revenues of $27.2 million for the second quarter of 2007 included $23.6 million of total product sales and $3.6 million from contracts, grants and research revenue. Other revenue is driven largely by reimbursement for R&D collaborations, including partnerships to develop assays for Tuberculosis with FIND, Avian Flu and flu A/B with the Centers for Disease Control and Prevention (CDC), and hemostasis with Instrumentation Laboratories.
Total product sales for the second quarter ended June 30, 2007 increased 25 percent to $23.6 million from $18.9 million for the second quarter 2006. The increase in product sales for the second quarter 2007 reflects a 165 percent increase in clinical product sales and a 43 percent increase in industrial sales, partially offset by a 26 percent decrease in biothreat sales, compared to the second quarter of 2006.
Sales by Market (millions)
                                             
 
        Q2 2007     Q2 2007     Q2 2006     Q2 2006  
        Total Sales     Percent of Total Sales     Total Sales     Percent of Total Sales  
 
Clinical
    $ 10.6         45       $ 4.0         21    
 
Industrial
    $ 4.0         17       $ 2.8         15    
 
Biothreat
    $ 9.0         38       $ 12.1         64    
 
- More-

 


 

Q2 2007 Earnings Announcement
August 7, 2007
Page 2 of 8
The increase in clinical sales was driven by market adoption of both the GeneXpert® System and the Company’s menu of available tests, specifically the Xpert MRSA product. Nationwide Hospital Acquired Infection (HAI) initiatives have contributed to the market traction the Company is experiencing, the most publicized of which is the Veterans Administration (VA) initiative. Cepheid continues to experience success within the VA hospital group. Currently, approximately 40 percent of the Company’s Xpert MRSA business is with VA hospitals, with the remaining amounts coming from other hospitals.
The increase in industrial sales resulted from increased government research funding and the increased presence that the addition of a new distributor offered in the U.S. industrial market. The decrease in biothreat sales resulted from a planned decrease in the purchase price of Anthrax cartridges to the United States Postal Service (USPS), in conjunction with an anticipated five-year purchase agreement currently in negotiation, and a shift in the quarterly purchase volume.
Gross margin on product sales was 41 percent for the second quarter of 2007 compared to 38 percent for the second quarter of 2006. Gross margin on product sales, without stock compensation expense and the amortization of acquired intangibles, was 42 percent for the second quarter of 2007 compared to 39 percent for the second quarter of 2006. The increase in gross margin was largely due to a higher percentage of sales realized in the clinical market worldwide.
Net loss for the second quarter of 2007 was approximately $5.2 million, or $0.10 per share, as compared to a net loss of approximately $7.0 million, or $0.13 per share, for the second quarter 2006. Net loss for the second quarter of 2007, adjusted for stock compensation expense and the amortization of acquired intangibles, was $2.7 million, or $0.05 per share, for the second quarter of 2007 as compared to $5.1 million, or $0.09 per share, for the second quarter of 2006. See the attached table for a reconciliation of GAAP and Non-GAAP amounts.
“The increase in clinical product sales during the second quarter reflects growing market traction for on-demand molecular diagnostics, particularly with the adoption of the Xpert MRSA test,” said John Bishop, Cepheid’s Chief Executive Officer. “Our expanding menu of tests, combined with the modular GeneXpert System that is adaptable for high- and low-volume needs, is broadening the customer base that can benefit from molecular diagnostics.”
Second Quarter 2007 and Recent Business Highlights
Following the launch of the Xpert MRSA test in the second quarter 2007, the Company moved to expand its U.S. sales and field service support organization, bringing the total to 28 sales and field service support personnel. Additionally, in order to increase its systems manufacturing capacity, the Company increased its facility square footage in Sunnyvale through the lease of a third building.
The Company signed a non-exclusive agreement with VWR International during the quarter to further support the U.S. industrial market. Under the terms of the agreement, VWR International will distribute the SmartCycler® System, SmartMix® HM master mix, and associated accessories to industrial customers in the U.S.

 


 

Q2 2007 Earnings Announcement
August 7, 2007
Page 3 of 8
In July, Cepheid introduced a number of new products at the American Association for Clinical Chemistry (AACC) Annual Meeting. These included the announcement of the GeneXpert Infinity Series, which includes 48 and 72 module systems with 24/7 robotic cartridge handling that will automatically load and unload test cartridges. The Infinity high-volume models are expected to be available in mid-2009.
Cepheid also announced that the entire GeneXpert family of systems will incorporate six color multiplex capabilities beginning in January 2008. Six color multiplexing will enable the ability to simultaneously test for up to 60 unrelated targets in a single test cartridge. Beginning in January 2008, all GeneXpert Systems will also include new Laboratory Information System (LIS) software for data output to central lab systems. The LIS software will also be available for purchase separately for application to existing GeneXpert four color systems.
The Company also announced the U.S. availability of a new line of research use only (RUO) products for Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), and Varicella Zoster Virus (VZV).
2007 Outlook
Based upon its success in the clinical market, the Company is raising its forward-looking financial guidance for product sales in 2007.
    Product sales are expected to be in the range of $105 million to $108 million.
 
    Other revenues are expected to remain in the range of $12 million to $15 million.
 
    On a consolidated basis, the Company expects 2007 total revenues to be in the range of $117 million to $123 million.
 
    The GAAP net loss for 2007, including the effect of stock compensation expense and the amortization of acquired intangibles, is expected to be in the range of $19 million to $22 million, or $0.34 to $0.40 per share based on expected weighted average shares outstanding of 55.6 million.
 
    In view of incremental increases in Sales and Marketing expenditures, the net loss, not including the effect of stock compensation expense and the amortization of acquired intangibles for 2007, is expected to remain in the range of $8 million to $11 million or $0.14 to $0.20 per share based on the same number of weighted average shares outstanding.
 
    The Company expects its quarterly operating results to continue to show a trend towards profitability in the second half of 2007 and currently expects to be profitable for the entire year of 2008, excluding stock compensation expense and the amortization of acquired intangibles.
Conference Call Information
Cepheid’s CEO, John Bishop, and Senior V.P. and CFO, John Sluis will host the conference call today at 4:30 pm Eastern Time to discuss Cepheid’s financial results and business highlights. Interested participants and investors may access the teleconference call by dialing 800-901-5218 (U.S./Canada) or 617-786-4511 (international), participant code 58587089. A telephonic replay will be available for seven days beginning at 6:30 p.m. Eastern Time today. Access numbers for this replay are 888-286-8010 (U.S./Canada) and 617-801-6888 (international); participant code 37880201.
The webcast of the call can be accessed on the Investor section of Cepheid’s Web site at www.cepheid.com. Web participants are encouraged to go to the Web site at least 15 minutes prior to the start of the call to register, download, and install any necessary audio software. After the live webcast, a replay will remain available in the Investors section of Cepheid’s Web site for 90 days.

 


 

Q2 2007 Earnings Announcement
August 7, 2007
Page 4 of 8
About Cepheid
Cepheid (NASDAQ: CPHD), based in Sunnyvale, Calif., is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems for genetic analysis in the clinical, industrial and biothreat markets. The Company’s systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. Cepheid’s easy-to-use systems integrate a number of complicated and time-intensive steps, including sample preparation, DNA amplification and detection, which enable the analysis of complex biological samples in its proprietary test cartridges. Through its strong molecular biology capabilities, the Company is focusing on those applications where rapid molecular testing is particularly important, such as identifying infectious disease and cancer in the clinical market; food, agricultural, and environmental testing in the industrial market; and identifying bio-terrorism agents in the biothreat market. See www.cepheid.com for more information.
This press release contains forward-looking statements that are not purely historical regarding Cepheid’s or its management’s intentions, beliefs, expectations and strategies for the future, including those relating to potential growth in clinical products sales, the status of government funding, timing of future product releases, future revenues and demand for certain test products, future net losses and profitability, other future operating results, the status of the USPS BDS program and collaboration and product development efforts. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the Company’s current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: our success in increasing direct sales, and the effectiveness of new sales personnel; the performance and market acceptance of products; sufficient customer demand; our ability to complete clinical trials successfully in a timely manner for products to be marketed in clinical markets; uncertainties related to the FDA regulatory and European regulatory processes; the scope of actual USPS funding in the future; the rate of environmental testing using the BDS conducted by the USPS, which will affect the amount of consumable products sold; the fact that future levels of government funding are inherently uncertain; unforeseen development and manufacturing problems; the need for additional licenses for new tests and other products and the terms of such licenses; lengthy sales cycles in certain markets; the Company’s reliance on distributors in some regions to market, sell and support our products; the occurrence of unforeseen expenditures, acquisitions or other transactions; the impact of acquisitions; unforeseen issues relating to acquisitions; the impact of competitive products and pricing; our ability to manage geographically-dispersed operations; and underlying market conditions worldwide. Readers should also refer to the section entitled “Risk Factors” in Cepheid’s Annual Report on Form 10-K for 2006 and its other reports filed with the Securities and Exchange Commission.
All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.
# # #
(FINANCIAL STATEMENTS FOLLOW)

 


 

Q2 2007 Earnings Announcement
August 7, 2007
Page 5 of 8
CEPHEID
CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
                                 
    Three Months Ended June 30,     Six Months Ended June 30,  
    2007     2006     2007     2006  
Revenues:
                               
Instrument sales
  $ 9,394     $ 4,030     $ 16,231     $ 8,568  
Reagent and disposable sales
    14,190       14,852       29,420       29,586  
 
                       
Total product sales
    23,584       18,882       45,651       38,154  
Contract revenues
    1,894       677       3,784       1,288  
Grant and government sponsored research revenue
    1,695       288       3,282       566  
 
                       
Total revenues
    27,173       19,847       52,717       40,008  
 
                       
Costs and operating expenses:
                               
Cost of product sales
    13,879       11,683       27,756       23,076  
Collaboration profit sharing
    2,731       3,843       6,228       7,654  
Research and development
    7,439       5,807       14,361       11,636  
Selling, general and administrative
    9,105       6,921       17,533       13,067  
 
                       
Total costs and operating expenses
    33,154       28,254       65,878       55,433  
 
                       
Loss from operations
    (5,981 )     (8,407 )     (13,161 )     (15,425 )
Other income, net
    740       1,365       1,767       1,711  
 
                       
 
                               
Net loss
  $ (5,241 )   $ (7,042 )   $ (11,394 )   $ (13,714 )
 
                       
 
                               
Basic and diluted net loss per share
  $ (0.10 )   $ (0.13 )   $ (0.21 )   $ (0.28 )
 
                       
 
                               
Shares used in computing basic and diluted net loss per share
    55,149       54,518       55,081       49,758  
 
                       

 


 

Q2 2007 Earnings Announcement
August 7, 2007
Page 6 of 8
CEPHEID
CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS
(in thousands)
                 
            December 31,  
    June 30, 2007     2006  
ASSETS
               
Current assets:
               
Cash and cash equivalents
  $ 7,176     $ 17,186  
Marketable securities
    38,250       77,750  
Accounts receivable, net
    23,592       15,246  
Inventory
    17,602       10,240  
Prepaid expenses and other current assets
    2,473       1,390  
 
           
Total current assets
    89,093       121,812  
Property and equipment, net
    15,831       14,097  
Restricted cash
    661       661  
Other non-current assets
    331       666  
Intangible assets and goodwill
    57,264       30,425  
 
           
Total assets
  $ 163,180     $ 167,661  
 
           
 
               
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
Current liabilities:
               
Accounts payable
  $ 11,096     $ 8,977  
Accrued compensation
    4,999       3,319  
Accrued royalties
    4,122       3,516  
Accrued collaboration profit sharing
    1,762       3,497  
Accrued other liabilities
    4,310       4,107  
Accrued expense for patent-related matter
          3,350  
Current portion of deferred revenue
    5,486       3,913  
Current portion of license fees payable
          447  
Current portion of equipment financing
    59       313  
Current portion of note payable
    4       11  
 
           
Total current liabilities
    31,838       31,450  
Long-term portion of deferred revenue
    3,244       2,663  
Long-term portion of equipment financing
          3  
Long-term portion of note payable
    2       41  
Deferred rent
    806       798  
 
           
Total liabilities
    35,890       34,955  
 
           
Shareholders’ equity:
               
Common stock
    252,655       251,132  
Additional paid-in capital
    19,583       15,065  
Accumulated other comprehensive loss
    (68 )     (5 )
Accumulated deficit
    (144,880 )     (133,486 )
 
           
Total shareholders’ equity
    127,290       132,706  
 
           
Total liabilities and shareholders’ equity
  $ 163,180     $ 167,661  
 
           

 


 

Q2 2007 Earnings Announcement
August 7, 2007
Page 7of 8
                                 
    Three months ended     Six months ended  
Table A - GAAP vs. Non GAAP Measures   June 30,     June 30,  
    2007     2006     2007     2006  
Total Product Sales
  $ 23,584     $ 18,882     $ 45,651     $ 38,154  
Total Revenues
  $ 27,173     $ 19,847     $ 52,717     $ 40,008  
 
                               
Cost of product sales
  $ 13,879     $ 11,683     $ 27,756     $ 23,076  
Stock compensation expense
    (36 )     (204 )     (302 )     (378 )
Amortization of acquired inventory step-up in basis
    (106 )           (170 )      
Amortization of purchased intangible assets
    (164 )           (367 )      
 
                       
Non-GAAP measure of cost of goods sold
  $ 13,573     $ 11,479     $ 26,917     $ 22,698  
 
                               
Gross Margin on Product Sales per GAAP
    41 %     38 %     39 %     40 %
Gross Margin on ProductSales per Non-GAAP
    42 %     39 %     41 %     41 %
 
                               
Gross Margin on Total Revenues per GAAP
    49 %     41 %     47 %     42 %
Gross Margin on Total Revenues per Non-GAAP
    50 %     42 %     49 %     43 %
 
                               
Research and development
  $ 7,439     $ 5,807     $ 14,361     $ 11,636  
Stock compensation expense
    (1,047 )     (725 )     (1,791 )     (1,318 )
 
                       
Non-GAAP measure of cost of research and development
  $ 6,392     $ 5,082     $ 12,570     $ 10,318  
Non-GAAP R&D measure as percent of Total Revenues
    24 %     26 %     24 %     26 %
 
                               
Selling, general and administrative
  $ 9,105     $ 6,921     $ 17,533     $ 13,067  
Stock compensation expense
    (1,215 )     (985 )     (2,206 )     (1,941 )
 
                       
Non-GAAP measure of cost of selling, general and administrative
  $ 7,890     $ 5,936     $ 15,327     $ 11,126  
Non-GAAP SG&A measure as percent of Total Revenues
    29 %     30 %     29 %     28 %
 
                               
Net Loss
  $ (5,241 )   $ (7,042 )   $ (11,394 )   $ (13,714 )
Stock compensation expense
    2,298       1,914       4,299       3,637  
Amortization of acquired inventory step-up in basis
    106             170        
Amortization of purchased intangible assets
    164             367        
 
                       
Non-GAAP measure of Net Loss
  $ (2,673 )   $ (5,128 )   $ (6,558 )   $ (10,077 )
 
                               
Basic and diluted net loss per share
  $ (0.095 )   $ (0.129 )   $ (0.207 )   $ (0.276 )
Stock compensation expense
  $ 0.042     $ 0.035     $ 0.078     $ 0.073  
Amortization of acquired inventory step-up in basis
  $ 0.002     $     $ 0.003     $  
Amortization of purchased intangible assets
  $ 0.003     $     $ 0.007     $  
 
                       
Non-GAAP measure of Net Loss
  $ (0.048 )   $ (0.094 )   $ (0.119 )   $ (0.203 )
 
                               
Shares used in computing basic and diluted net loss per share
    55,149       54,518       55,081       49,758  

 


 

Q2 2007 Earnings Announcement
August 7, 2007
Page 8 of 8
                                 
Table B - Instrument and Reagent Sales Mix   Three months ended     Six months ended  
    June 30,     June 30,  
    2007     2006     2007     2006  
Product Sales
                               
Instrument sales
  $ 9,394     $ 4,030     $ 16,231     $ 8,568  
Reagent and disposable sales
    14,190       14,852       29,420       29,586  
 
                       
Total product sales
  $ 23,584     $ 18,882     $ 45,651     $ 38,154  
 
                               
Percent of Product Sales
                               
Instruments
    40 %     21 %     36 %     22 %
Reagents and disposables
    60 %     79 %     64 %     78 %
 
                       
Total product sales
    100 %     100 %     100 %     100 %
 
                               
                                 
Table C - Geographic Sales Mix   Three months ended     Six months ended  
    June 30,     June 30,  
    2007     2006     2007     2006  
 
                               
Percent of Instrument and service sales
                               
US & ROW
    73 %     72 %     67 %     73 %
Europe
    27 %     28 %     33 %     27 %
 
                       
Total Instrument and Service Sales
    100 %     100 %     100 %     100 %
 
                               
Percent of reagent and disposable sales (including USPS)
                               
US & ROW
    82 %     98 %     87 %     98 %
Europe
    18 %     2 %     13 %     2 %
 
                       
Total Reagent and Disposable Sales
    100 %     100 %     100 %     100 %
 
                               
Percent of Reagent and Disposable Sales (without USPS)
                               
US & ROW
    51 %     89 %     59 %     90 %
Europe
    49 %     11 %     41 %     10 %
 
                       
Total Reagent and Disposable Sales
    100 %     100 %     100 %     100 %
 
                               
Percent of Total Product Sales (including USPS)
                               
US & ROW
    78 %     92 %     80 %     93 %
Europe
    22 %     8 %     20 %     7 %
 
                       
Total Product Sales (including USPS)
    100 %     100 %     100 %     100 %
 
                               
Percent of Total Product Sales (without USPS)
                               
US & ROW
    64 %     79 %     63 %     80 %
Europe
    36 %     21 %     37 %     20 %
 
                       
Total Reagent and Disposable Sales
    100 %     100 %     100 %     100 %

 

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