-----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, WnWs4K0PhowkSCk7ivSy3hwRX5rJUS1IwHBZz6QoR44y1g2Res2GdinqI0Tu+h1h zCtfcrwp/yGyd8BkhN+Tdg== 0001193125-10-090541.txt : 20100423 0001193125-10-090541.hdr.sgml : 20100423 20100422212102 ACCESSION NUMBER: 0001193125-10-090541 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20100422 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100423 DATE AS OF CHANGE: 20100422 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: 10765627 BUSINESS ADDRESS: STREET 1: 904 CARIBBEAN DRIVE CITY: SUNNYVALE STATE: CA ZIP: 94089 BUSINESS PHONE: 4085414191 MAIL ADDRESS: STREET 1: 904 CARIBBEAN DRIVE CITY: SUNNYVALE STATE: CA ZIP: 94089 8-K 1 d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

 

FORM 8-K

 

 

Current Report Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

April 22, 2010

Date of Report (Date of earliest event reported)

 

 

CEPHEID

(Exact name of Registrant as specified in its charter)

 

 

 

California   000-30755   77-0441625

(State or other jurisdiction

of incorporation)

  (Commission file number)  

(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 obligations of the registrant under any of the following provisions (see General Instruction A.2 below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ 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.

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 April 22, 2010, Cepheid issued a press release announcing its financial results for the quarter ended March 31, 2010 and certain other information. The press release is attached to this report as Exhibit 99.01.

In the press release and during a conference call and webcast regarding Cepheid’s quarterly results, Cepheid supplemented its reported GAAP financial information with non-GAAP measures that do not include employee share-based compensation expense and amortization of purchased intangible assets and, for the first quarter of 2009, restructuring charges. The presentation of this additional information is not meant to be considered in isolation or as a substitute for results prepared in accordance with GAAP. Cepheid’s management uses the non-GAAP information internally to evaluate its ongoing business, continuing operational performance and cash requirements, and believes these non-GAAP measures are useful to investors as they provide a basis for evaluating Cepheid’s cash requirements and additional insight into the underlying operating results and Cepheid’s ongoing performance in the ordinary course of its operations.

These non-GAAP measures may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Cepheid believes that non-GAAP measures have limitations in that they do not reflect all of the amounts associated with its results of operations as determined in accordance with GAAP and that these measures should only be used to evaluate Cepheid’s results of operations in conjunction with the corresponding GAAP measures.

As described above, Cepheid excludes the following items from one or more of its non-GAAP measures when applicable:

Employee share-based compensation expense. These expenses consist primarily of expenses for employee stock options and employee restricted stock under ASC 718 (formerly SFAS 123(R)). Cepheid excludes employee share-based compensation expenses from its non-GAAP measures primarily because they are non-cash expenses that Cepheid does not believe are reflective of ongoing operating results. Further, as Cepheid applies ASC 718, it believes that it is useful to investors to understand the impact of the application of ASC 718 on its results of operations.

Amortization of purchased intangible assets. Cepheid incurs amortization of purchased intangible assets in connection with acquisitions. Cepheid excludes these items because these expenses are not reflective of ongoing operating results in the period incurred. These amounts arise from Cepheid’s prior acquisitions and have no direct correlation to the operation of Cepheid’s business.


Item 9.01 Financial Statements and Exhibits.

 

  (d) Exhibits.

 

Exhibit
No.

  

Exhibit Title

99.01    Press release dated April 22, 2010.


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: April 22, 2010     By:  

/S/    ANDREW D. MILLER        

    Name:   Andrew D. Miller
    Title:   Senior Vice President, Chief Financial Officer


Exhibit List

 

Exhibit
No.

  

Exhibit Title

99.01    Press release dated April 22, 2010.
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

LOGO    CONTACTS:   
   For Media Inquiries:    For Investor Inquiries:
  

Jared Tipton

Cepheid Corporate Communications

Tel: (408) 400 8377

jared.tipton@cepheid.com

   Jacquie Ross

Cepheid Investor Relations

Tel: (408) 400 8329

investor.relations@cepheid.com

Cepheid

904 Caribbean Drive

Sunnyvale, CA 94089

Telephone: 408.541.4191

Fax: 408.541.4192

CEPHEID REPORTS 2010 FIRST QUARTER RESULTS

Clinical Growth of 54% Driven by Broad Test Menu Adoption

SUNNYVALE, California, April 22, 2010 – Cepheid (Nasdaq: CPHD) today reported revenue for the first quarter of 2010 of $48.0 million. Net loss was $4.3 million, or $(0.07) per share, which compares to revenue of $38.8 million and a net loss of $7.6 million, or $(0.13) per share, in the first quarter of 2009.

Excluding amortization of purchased intangible assets and stock compensation expense, non-GAAP net loss for the first quarter was $0.2 million, or $(0.00) per share. This compares to a non-GAAP net loss of $3.0 million, or $(0.05) per share, in the first quarter of 2009, which excluded amortization of purchased intangible assets, stock compensation and restructuring expenses.

“As Cepheid’s diagnostic offering continues to expand, now with nine tests available in the United States, the dramatic improvements offered by the GeneXpert® System over traditional testing methodologies are proving increasingly compelling,” said John Bishop, Cepheid’s Chief Executive Officer. “This led to solid system placements in the first quarter, and record sales of our clinical diagnostic tests which deliver the fastest and, in many cases, the most accurate molecular results to support clinical decisions that can improve patient management and reduce health care costs.”

“Even as we work diligently to narrow our net loss further and move to profitability, Cepheid is investing heavily in further expansion of our test menu and in the maintenance of our technology leadership,” continued Bishop. “By the end of 2010, we intend to deliver additional tests to the US market, including our Xpert® MRSA/SA test for presurgical identification of colonized patients who are at greater risk of post surgical infection.”


Operational Overview

 

   

Total product sales of $47.2 million in the first quarter of 2010, compared to $36.6 million in the first quarter of 2009. By industry, product sales were, in millions:

 

     Three Months Ended
March 31,
 
     2010    2009    Change  

Clinical Systems

   $ 7.0    $ 4.8    48

Clinical Reagents

     29.6      19.0    56
                

Total Clinical

     36.6      23.8    54

Industrial

     4.7      3.7    27

Biothreat

     5.2      7.9    -35

Partner

     0.7      1.2    -41
                

Total Product Sales

   $ 47.2    $ 36.6    29
                

 

   

By geography, product sales were, in millions:

 

     Three Months Ended
March 31,
 
     2010    2009    Change  

North America

        

Clinical

   $ 28.6    $ 18.4    56

Other

     8.5      10.8    -22
                

Total North America

     37.1      29.2    27

International

        

Clinical

     8.0      5.4    48

Other

     2.1      2.0    5
                

Total International

     10.1      7.4    36
                

Total Product Sales

   $ 47.2    $ 36.6    29
                

 

   

During the quarter, Cepheid installed a total of 124 GeneXpert systems and 587 modules. As of March 31, 2010, a cumulative total of 1,499 GeneXpert systems and 8,140 modules have been placed worldwide.

 

   

GAAP gross margin on product sales was 45% and non-GAAP gross margin on product sales was 46%, which compares to 43% and 45%, respectively, in the first quarter of 2009.

 

   

Cash, cash equivalents and investments, net of associated debt, were $39.2 million as of March 31, 2010.

 

   

DSO was 53 days.

Business Outlook

For the fiscal year ending December 31, 2010, the company expects:

 

   

Total revenue to be in the range of $195 to $205 million;

 

   

Net loss in the range of $(0.35) to $(0.27) per share;

 

   

Non-GAAP net income ranging from a loss of $(0.05) to net income of $0.02 per share.

Expected non-GAAP net income/loss excludes approximately $16.5 million related to stock compensation expense and approximately $1.5 million related to the amortization of acquired intangibles.


Accessing Cepheid’s Q110 Results Conference Call

The company will host a management presentation at 2:00 p.m. Pacific Time on Thursday, April 22, 2010 to discuss the results. To access the live webcast, please visit Cepheid’s website at www.cepheid.com/investors at least 15 minutes before the scheduled start time to download any necessary audio or plug-in software. A replay of the webcast will be available shortly following the call and will remain available for at least 90 days.

Interested participants may also listen to the live teleconference call by dialing (866) 356-4441 (domestic) or (617) 597-5396 (international), and entering participant code 57219884. A replay will be available for seven days beginning at 4 p.m. Pacific Time. Access numbers for this replay are (888) 286-8010 (domestic) and (617) 801-6888 (international), with participant code 22168742.

About Cepheid

Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests 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. The company’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.

Use of Non-GAAP Measures

The company has supplemented its reported GAAP financial information with non-GAAP measures that do not include employee share-based compensation expense and amortization of purchased intangible assets and, for the first quarter of 2009, restructuring charges. The presentation of this additional information is not meant to be considered in isolation or as a substitute for results prepared in accordance with GAAP. The company’s management uses the non-GAAP information internally to evaluate its ongoing business, continuing operational performance and cash requirements, and believes these non-GAAP measures are useful to investors as they provide a basis for evaluating the company’s cash requirements and additional insight into the underlying operating results and the company’s ongoing performance in the ordinary course of its operations.

These non-GAAP measures may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. The company believes that non-GAAP measures have limitations in that they do not reflect all of the amounts associated with its results of operations as determined in accordance with GAAP and that these measures should only be used to evaluate the company’s results of operations in conjunction with the corresponding GAAP measures.


As described above, the company excludes the following items from one or more of its non-GAAP measures when applicable:

Employee stock-based compensation expense. These expenses consist primarily of expenses for employee stock options and employee restricted stock under ASC 718 (formerly SFAS 123(R)). The company excludes employee stock-based compensation expenses from its non-GAAP measures primarily because they are non-cash expenses that the company does not believe are reflective of ongoing operating results. Further, as the company applies ASC 718, it believes that it is useful to investors to understand the impact of the application of ASC 718 on its results of operations.

Amortization of purchased intangible assets. The company incurs amortization of purchased intangible assets in connection with acquisitions. The company excludes these items because these expenses are not reflective of ongoing operating results in the period incurred. These amounts arise from the company’s prior acquisitions and have no direct correlation to the operation of the company’s business.

Forward-Looking Statements

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 product pipeline and timeline, product performance, future revenues and future net income or loss. 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 new products; sufficient customer demand; our ability to develop and complete clinical trials successfully in a timely manner for new products; uncertainties related to the FDA regulatory and European regulatory processes; the level of testing at clinical customer sites; changes in the protocols or levels of testing for Healthcare Associated Infections (HAIs); the company’s ability to successfully introduce and sell products in clinical markets other than HAIs; the rate of environmental biothreat testing conducted by the USPS, which will affect the amount of consumable products sold to the USPS; unforeseen development and manufacturing problems; the potential need for additional intellectual property licenses for 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 its products; the occurrence of unforeseen expenditures, acquisitions or other transactions; the impact of acquisitions and stock-based compensation expense; the impact of competitive products and pricing; the company’s ability to manage geographically-dispersed operations; and underlying market conditions worldwide, including the uncertain impact of the significant global economic downturn on our business, and that of our customers, potential customers and business partners. Readers should also refer to the section entitled “Risk Factors” in Cepheid’s Annual Report on Form 10-K, its most recent Quarterly Report on Form 10-Q, 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 TABLES FOLLOW


CEPHEID

CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

 

     Three Months Ended
March 31,
 
     2010     2009  

Revenues:

    

System sales

   $ 10,917      $ 7,909   

Reagent and disposable sales

     36,265        28,679   
                

Total product sales

     47,182        36,588   

Other revenues

     863        2,179   
                

Total revenues

     48,045        38,767   
                

Costs and operating expenses:

    

Cost of product sales

     26,071        20,690   

Collaboration profit sharing

     1,655        2,629   

Research and development

     9,701        10,338   

Sales and marketing

     8,985        6,812   

General and administrative

     5,715        5,269   

Restructuring charge

     —          747   
                

Total costs and operating expenses

     52,127        46,485   
                

Loss from operations

     (4,082     (7,718

Other income (expense), net

     (276     72   
                

Loss before benefit for income taxes

     (4,358     (7,646

Benefit for income taxes

     19        44   
                

Net loss

   $ (4,339   $ (7,602
                

Basic and diluted net loss per share

   $ (0.07   $ (0.13
                

Shares used in computing basic and diluted net loss per share

     58,936        57,832   
                


CEPHEID

CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS

(in thousands)

 

     March 31,
2010
    December 31,
2009
 
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 29,132      $ 35,786   

Short-term investments

     20,660        24,931   

Accounts receivable, net

     28,065        23,014   

Inventory

     36,734        38,015   

Prepaid expenses and other current assets

     3,419        2,421   
                

Total current assets

     118,010        124,167   

Property and equipment, net

     25,316        24,021   

Other non-current assets

     458        495   

Intangible assets

     29,661        30,817   

Goodwill

     18,626        18,626   
                

Total assets

   $ 192,071      $ 198,126   
                
LIABILITIES AND SHAREHOLDERS’ EQUITY     

Current liabilities:

    

Accounts payable

   $ 21,345      $ 21,242   

Accrued compensation

     6,875        8,869   

Accrued royalties

     9,490        12,929   

Accrued collaboration profit sharing

     1,654        826   

Accrued other liabilities

     1,737        1,800   

Current portion of deferred revenue

     3,137        2,923   

Current portion of note payable

     296        108   

Bank borrowing

     10,598        14,618   
                

Total current liabilities

     55,132        63,315   

Long-term portion of deferred revenue

     2,245        2,279   

Note payable, less current portion

     462        732   

Other liabilities

     3,578        4,234   
                

Total liabilities

     61,417        70,560   
                

Shareholders’ equity:

    

Common stock

     276,513        273,052   

Additional paid-in capital

     60,373        56,408   

Accumulated other comprehensive income (loss)

     372        371   

Accumulated deficit

     (206,604     (202,265
                

Total shareholders’ equity

     130,654        127,566   
                

Total liabilities and shareholders’ equity

   $ 192,071      $ 198,126   
                


CEPHEID

CONDENSED UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

 

     Three Months Ended
March 31,
 
     2010     2009  

Cash flows from operating activities:

    

Net loss

   $ (4,339   $ (7,602

Adjustments to reconcile net loss to net cash provided by (used in) operating activities:

    

Depreciation and amortization

     2,325        2,090   

Amortization of intangible assets

     1,696        1,695   

Amortization of prepaid compensation expense

     —          63   

Stock-based compensation related to employees and consulting services rendered

     3,746        3,547   

Unrealized gain on auction rate securities

     (1,425     (2,971

Unrealized loss on put option

     1,571        3,079   

Deferred rent

     25        (74

Changes in operating assets and liabilities:

    

Accounts receivable

     (5,051     587   

Inventory

     1,500        (2,139

Prepaid expenses and other current assets

     (997     1,358   

Other non-current assets

     36        (15

Accounts payable and other current liabilities

     (2,254     6,111   

Accrued compensation

     (1,994     (1,988

Deferred revenue

     180        (563
                

Net cash provided by (used in) operating activities

     (4,981     3,178   
                

Cash flows from investing activities:

    

Capital expenditures

     (3,998     (1,420

Payments for technology licenses

     (1,000     (1,500

Cost of acquisition, net

     (574     (148

Proceeds from maturities of short-term investments

     4,125        —     

Proceeds from the sale of fixed assets

     78        8   

Transfer from unrestricted cash

     —          1,500   
                

Net cash used in investing activities

     (1,369     (1,560
                

Cash flows from financing activities:

    

Net proceeds from the issuance of common shares and exercise of stock options and awards

     3,461        1,551   

Principal payments of notes payable

     (82     —     

Principal payments of bank borrowing

     (4,020     (41
                

Net cash provided by (used in) financing activities

     (641     1,510   
                

Effect of exchange rate change on cash

     337        202   
                

Net increase (decrease) in cash and cash equivalents

     (6,654     3,330   

Cash and cash equivalents at beginning of period

     35,786        23,478   
                

Cash and cash equivalents at end of period

   $ 29,132      $ 26,808   
                


CEPHEID

RECONCILIATION OF GAAP TO NON-GAAP MEASURES (UNAUDITED)

(in thousands, except per share data)

 

     Three Months Ended
March 31,
 
     2010     2009  

Cost of product sales

   $ 26,071      $ 20,690   

Stock compensation expense

     (470     (354

Amortization of purchased intangible assets

     (328     (324
                

Non-GAAP measure of cost of product sales

   $ 25,273      $ 20,012   

Gross margin on product sales per GAAP

     45     43

Gross margin on product sales per non-GAAP

     46     45

Operating expenses

   $ 24,401      $ 22,419   

Stock compensation expense

     (3,276     (3,068

Amortization of purchased intangible assets

     (81     (73
                

Non-GAAP measure of operating expenses

   $ 21,044      $ 19,278   

Income (loss) from operations

   $ (4,082   $ (7,718

Restructuring charge

     —          747   

Stock compensation expense

     3,746        3,422   

Amortization of purchased intangible assets

     409        397   
                

Non-GAAP measure of income (loss) from operations

   $ 73      $ (3,152

Net income (loss)

   $ (4,339   $ (7,602

Restructuring charge

     —          747   

Stock compensation expense

     3,746        3,422   

Amortization of purchased intangible assets

     409        397   
                

Non-GAAP measure of net income (loss)

   $ (184   $ (3,036

Basic net income (loss) per share

   $ (0.07   $ (0.13

Restructuring charge

     —          0.01   

Stock compensation expense

     0.06        0.06   

Amortization of purchased intangible assets

     0.01        0.01   
                

Non-GAAP measure of net income (loss)

   $ (0.00   $ (0.05

Shares used in computing basic and diluted net income (loss) per share

     58,936        57,832   

# # # #

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-----END PRIVACY-ENHANCED MESSAGE-----