-----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, QK/s1ODFwrjhgWEnvMd5Kkjq9D/sz/CRPAJV6n49cX4Z5R0+s1cqJp3Acf1B/spn os6qfbLzcaovztEpuqXeSQ== 0001104659-05-050039.txt : 20051025 0001104659-05-050039.hdr.sgml : 20051025 20051025160435 ACCESSION NUMBER: 0001104659-05-050039 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20051025 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051025 DATE AS OF CHANGE: 20051025 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ABGENIX INC CENTRAL INDEX KEY: 0001052837 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 943248826 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-24207 FILM NUMBER: 051154526 BUSINESS ADDRESS: STREET 1: 6701 KAISER DRIVE CITY: FREMONT STATE: CA ZIP: 94555 BUSINESS PHONE: 5106086500 MAIL ADDRESS: STREET 1: 6701 KAISER DRIVE CITY: FREMONT STATE: CA ZIP: 94555 8-K 1 a05-18913_18k.htm CURRENT REPORT OF MATERIAL EVENTS OR CORPORATE CHANGES

 

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

 

Date of report (Date of earliest event reported):  October 25, 2005

 

Abgenix, Inc.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

(State or Other Jurisdiction of Incorporation)

 

000-24207

 

94-3248826

(Commission File Number)

 

(IRS Employer Identification No.)

 

 

 

6701 Kaiser Drive, Fremont California

 

94555

(Address of Principal Executive Offices)

 

(Zip Code)

 

 

 

510-284-6500

(Registrant’s Telephone Number, Including Area Code)

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

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

 

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

 

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

 

o  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 



 

Item 2.02               Results of Operations and Financial Condition

 

On October 25, 2005, Abgenix, Inc. issued a press release reporting the company’s financial results for the quarter ended September 30, 2005.  A copy of the press release is attached to this current report on Form 8-K as Exhibit 99.1.

 

Item 9.01               Financial Statements and Exhibits

 

(c)                  Exhibits.

 

Exhibit
No.

 

Description

 

 

 

99.1

 

Press Release of Abgenix, Inc. dated October 25, 2005

 

2



 

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.

 

 

ABGENIX, INC.

 

 

 

 

Dated:  October 25, 2005

By:

   /s/ H. Ward Wolff

 

 

H. Ward Wolff

Chief Financial Officer and

Senior Vice President, Finance

 

3



 

EXHIBIT INDEX

 

EXHIBIT
NO.

 

DESCRIPTION

 

 

 

99.1

 

Press Release of Abgenix, Inc. dated October 25, 2005

 


EX-99.1 2 a05-18913_1ex99d1.htm EXHIBIT 99

Exhibit 99.1

 

 

 

 

FOR IMMEDIATE RELEASE

 

Contact:

Greg Mann

 

Director

 

Corporate Communications & Investor Relations

 

(510) 284-6566

 

Abgenix Announces Third Quarter 2005 Financial Results

 

FREMONT, Calif. - October 25, 2005 - Abgenix, Inc. (NASDAQ: ABGX) today announced financial results for the third quarter ended September 30, 2005.  The company reported a net loss of $36.8 million, or $0.41 per share, for the third quarter of 2005, compared to $42.4 million, or $0.48 per share, for the same period in 2004.

 

Net cash used in operating activities in the third quarter of 2005 was $21.8 million, compared to $36.5 million in the third quarter of 2004.  During the quarter, the company repurchased approximately $13.8 million of its outstanding convertible notes due in 2007, and ended the third quarter of 2005 with $343.6 million in cash, cash equivalents and marketable securities. 

 

“We continue to execute on our goals for 2005, including progress with our partner, Amgen, towards the initiation of our regulatory filing to the FDA for panitumumab before year-end 2005,” said Bill Ringo, president and chief executive officer of Abgenix.  “Our third quarter performance reflects expense reductions realized from our recently announced restructuring and facility consolidation, efforts to expand our product portfolio, and investment in the development and potential commercialization of panitumumab.”

 

Revenues for the third quarter of 2005 were $4.7 million compared to $3.1 million for the same period in 2004.  Revenues for the third quarter of 2005 consisted primarily of contract revenues from technology licensing agreements and included licensing revenues and an IND-related milestone from our partner Agensys.  For the third quarter of 2004, revenues included a milestone payment from Amgen for advancement of denosumab (AMG-162), a XenoMouse®-derived antibody, into pivotal clinical trials for bone loss.  The company’s contract revenues generally vary from period to period based on the progress of research and development efforts by the company’s collaborators and licensees.

 

-more-

 



 

Operating expenses for the third quarter of 2005 were $40.8 million, compared to $45.1 million for the same period in 2004.  The majority of third quarter 2005 research and development costs related to advancement of the company’s proprietary clinical product candidates, including its lead oncology product candidate, panitumumab, and ABX-10241, a fully human antibody being studied for the potential treatment of secondary hyperparathyroidism (SHPT). Included in both periods were manufacturing start-up costs related to the company’s antibody production facility.  Previously announced restructuring activities and other cost-containment initiatives contributed to the reduction in general and administrative expenses in 2005.

 

Third Quarter 2005 and Recent Company Highlights

 

                  Panitumumab development progress:

 

                  Top-line data from the ex-U.S. pivotal study (Study 408) are expected to be announced by mid-November 2005.  The trial, anticipated to be the basis of a future Biologic License Application (BLA), measures progression free survival following panitumumab monotherapy for the treatment of advanced colorectal cancer (CRC) patients who have failed standard chemotherapy regimens, including irinotecan and oxaliplatin.

 

                  Dependent on the data outcome, initiation of the BLA for panitumumab monotherapy in advanced CRC patients who have failed such chemotherapy regimens is expected in late fourth quarter 2005. 

 

                  Fast track status was granted for panitumumab by the U.S. Food and Drug Administration (FDA).  Under the FDA Modernization Act of 1997, fast track designation allows the FDA to accept, on a rolling basis, portions of a marketing application for review prior to the completion of the final registration package.

 

                  As recently announced by our partner, Amgen, new interim data from two ongoing, single-arm, U.S. Phase 2 studies (Study 167 and Study 250) support that panitumumab is active as monotherapy in patients with advanced colorectal cancer who have failed multiple standard chemotherapy regimens.

 

                  Enrollment continues in the Panitumumab Advanced Colorectal Cancer Evaluation (PACCE) Study.  The randomized, multi-center, controlled, open-label Phase 3 trial investigates the potential benefit of panitumumab in the first-line colorectal cancer setting when administered in combination with chemotherapy and Avastin® (bevacizumab).

 

                  Results of a Phase 2 study of panitumumab as a single agent therapy in metastatic renal cell carcinoma (mRCC) were presented on October 23, 2005 at the Fourth International Kidney Cancer Symposium in Chicago.  No objective response was observed and overall survival was comparable to that associated with available mRCC treatments. Panitumumab appeared to be generally well tolerated and no panitumumab-induced human anti-human antibodies were observed.

 

2



 

                  Following our decision to co-promote panitumumab, we continued to make progress in recruiting the leadership of our commercial team and coordinating our efforts with Amgen.

 

                  Presentations of clinical and pre-clinical panitumumab studies at upcoming conferences:

 

                  Results of two clinical trials will be presented at the upcoming European Cancer Conference, or ECCO, in Paris on October 30-November 3, 2005.

 

                  Primary analysis of results from the second part of a safety study of panitumumab plus irinotecan-containing chemotherapy in first line patients with metastatic CRC.  Results from the first part of this study were presented at the 29th Congress of the European Society for Medical Oncology (ESMO) in November 2004.

 

                  Primary analysis of results from a Phase 2 study comparing panitumumab plus standard chemotherapy versus chemotherapy alone in first line advanced non-small cell lung cancer.  Abgenix announced top-line results of this study in a press release on July 26, 2005.

 

                  Abstracts of five pre-clinical studies of panitumumab will be presented at the upcoming joint conference of the American Association of Cancer Research (AACR), National Cancer Institute (NCI) and the European Organisation for Research and Treatment of Cancer (EORTC) on November 14-18, 2005 in Philadelphia, PA.

 

                  Proprietary and partner pipeline activities:

 

                  Abgenix is entitled to a milestone payment from Pfizer following the filing by Pfizer of a Clinical Trial Application (CTA) with several European regulatory authorities. The CTA represents the fourth fully human antibody product candidate to enter clinical studies from the antibody research collaboration with Pfizer.

 

Conference call information

 

Abgenix will hold a conference call today at 4:30 pm ET, 1:30 pm PT to discuss financial results. To participate in the teleconference, please dial 866-700-7441 fifteen minutes before the conference begins. International callers should dial 617-213-8839. The pass code is 74073994. The call will also be webcast live at www.abgenix.com. A replay of the call will be available on the company’s website or by dialing 888-286-8010.  International callers should dial 617-801-6888. The replay participant code is 87765844.

 

3



 

About Abgenix

 

Abgenix is a biopharmaceutical company focused on the discovery, development and manufacturing of fully human therapeutic antibodies. The company’s antibody development platform includes a leading antibody technology and state-of-the-art manufacturing capabilities that enable the rapid generation, selection and production of high affinity antibodies with the potential to target disease. Abgenix leverages its leadership position in human antibody technology to build a diversified product portfolio through its own development efforts and the establishment of collaborations with multiple pharmaceutical and biotechnology companies. For more information on Abgenix, visit the company’s website at www.abgenix.com.

 

Statements made in this press release about Abgenix’s technologies, product development activities, clinical study results, timing of potential FDA filings for panitumumab, collaborative and co-promotion arrangements and process science and manufacturing activities and about its projected financial results and the achievement of milestone or similar payments, other than statements of historical fact, are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with conducting clinical trials, the progress of research and product development programs, product manufacturing, regulatory filing, review and approval processes, competitive products and services, future capital requirements and the extent and breadth of Abgenix’s patent portfolio. Please see Abgenix’s public filings with the Securities and Exchange Commission for information about risks that may affect Abgenix, including its Form 10-K for the year ended December 31, 2004, and periodic reports on Form 10-Q and Form 8-KAbgenix is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements.

 

###

 

4



ABGENIX, INC.

CONSOLIDATED STATEMENT OF OPERATIONS DATA

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

(in thousands except per share data)

 

2005

 

2004

 

2005

 

2004

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

Contract revenue

 

$

4,689

 

$

3,116

 

$

10,751

 

$

10,195

 

Contract manufacturing revenue

 

 

 

 

1,325

 

Total revenues

 

4,689

 

3,116

 

10,751

 

11,520

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Cost of goods manufactured

 

 

 

 

1,857

 

Research and development

 

29,345

 

29,660

 

100,674

 

94,265

 

Manufacturing start-up costs

 

5,181

 

6,351

 

11,965

 

16,487

 

General and administrative

 

5,035

 

7,673

 

16,003

 

21,038

 

Amortization of intangible assets

 

846

 

1,441

 

3,728

 

5,024

 

Impairment of intangible assets

 

 

 

25,000

 

17,241

 

Restructuring and other

 

398

 

 

15,138

 

 

Total operating expenses

 

40,805

 

45,125

 

172,508

 

155,912

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(36,116

)

(42,009

)

(161,757

)

(144,392

)

 

 

 

 

 

 

 

 

 

 

Other income (expenses):

 

 

 

 

 

 

 

 

 

Interest and other income (expenses), net

 

3,257

 

1,347

 

9,216

 

4,831

 

Interest expense

 

(3,980

)

(1,758

)

(11,048

)

(5,048

)

Total other expenses

 

(723

)

(411

)

(1,832

)

(217

)

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(36,839

)

$

(42,420

)

$

(163,589

)

$

(144,609

)

Basic and diluted net loss per share

 

$

(0.41

)

$

(0.48

)

$

(1.83

)

$

(1.63

)

Shares used in computing basic and diluted net loss per share

 

89,949

 

88,845

 

89,617

 

88,609

 

 



ABGENIX, INC.

RECONCILIATION OF GAAP NET LOSS TO NON-GAAP NET LOSS (1)

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

(in thousands except per share data)

 

2005

 

2004

 

2005

 

2004

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss

 

$

(36,839

)

$

(42,420

)

$

(163,589

)

$

(144,609

)

Add: Impairment of intangible assets

 

 

 

25,000

 

17,241

 

Restructuring and other

 

398

 

 

15,138

 

 

Non-GAAP net loss

 

$

(36,441

)

$

(42,420

)

$

(123,451

)

$

(127,368

)

Basic and diluted non-GAAP net loss per share

 

$

(0.41

)

$

(0.48

)

$

(1.38

)

$

(1.44

)

Shares used in computing basic and diluted non-GAAP net loss per share

 

89,949

 

88,845

 

89,617

 

88,609

 

 


(1)  Non-GAAP amounts are intended to illustrate the Company’s results of operations excluding impairment of intangible assets and restructuring charges.  The non-GAAP results are not in accordance with, or an alternative for, generally accepted accounting principles and may be different from non-GAAP measures used by other companies.

 



ABGENIX, INC.

CONSOLIDATED BALANCE SHEET DATA

 

(in thousands)

 

September 30,
2005

 

December 31,
2004

 

 

 

(unaudited)

 

*

 

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

 

$

343,604

 

$

416,329

 

Other current assets

 

17,629

 

19,187

 

Total current assets

 

361,233

 

435,516

 

Property and equipment, net

 

199,884

 

223,004

 

Long-term investments

 

17,078

 

23,300

 

Intangible assets, net

 

66,063

 

94,790

 

Deposits and other assets

 

34,394

 

36,108

 

Total assets

 

$

678,652

 

$

812,718

 

Deferred revenue

 

$

8,920

 

$

11,692

 

Accrued restructuring charges

 

2,386

 

 

Other current liabilities

 

22,728

 

23,257

 

Total current liabilities

 

34,034

 

34,949

 

Convertible notes

 

449,890

 

463,630

 

Deferred rent

 

7,615

 

7,519

 

Non-current portion of accrued restructuring charges

 

5,214

 

 

Other long-term liabilities

 

63,941

 

25,626

 

Redeemable convertible preferred stock

 

49,869

 

49,869

 

Stockholders’ equity

 

68,089

 

231,125

 

Total liabilities and stockholders’ equity

 

$

678,652

 

$

812,718

 

 


* Derived from the December 31, 2004 audited financial statements.

 


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