-----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, SiR6ACU62ks45xt99PgZEx+sweNg88XxjH0WvuaHX6sO2nZSC08s5PvArzPpWmnU IeOB/6S8VcvWTlafcGkg8A== 0001104659-05-034146.txt : 20050726 0001104659-05-034146.hdr.sgml : 20050726 20050726161004 ACCESSION NUMBER: 0001104659-05-034146 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050726 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050726 DATE AS OF CHANGE: 20050726 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: 05974353 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 a05-10812_28k.htm 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

 

Date of report (Date of earliest event reported):               July 26, 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 July 26, 2005, Abgenix, Inc. issued a press release reporting the company’s financial results for the quarter ended June 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 July 26, 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:  July 26, 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 July 26, 2005

 

4


EX-99.1 2 a05-10812_2ex99d1.htm EX-99.1

Exhibit 99.1

 

News

 

 

 

 

 

 

 

release

 

FOR IMMEDIATE RELEASE

 

Contact:

 

Greg Mann

 

 

Director

 

 

Corporate Communications & Investor Relations

 

 

(510) 608-6500 or (510) 284-6566

 

 

Abgenix Announces Second Quarter 2005 Financial Results

Strategic Review Results in Special Charges

 

FREMONT, Calif.—July 26, 2005—Abgenix, Inc. (Nasdaq: ABGX) today reported financial results for the second quarter ended June 30, 2005. In light of the special charges resulting from the completion of a strategic review and restructuring during the second quarter, the company is presenting financial results under generally accepted accounting principles (GAAP) and non-GAAP for the period. A reconciliation of the GAAP and non-GAAP financial results is set forth at the end of this press release.

 

Financial Results

 

The company reported a net loss on a GAAP basis of $84.1 million, or $0.94 per share, for the second quarter of 2005, compared to $60.6 million, or $0.68 per share, for the same period in 2004.  The financial results for the second quarter of 2005 include restructuring charges of $14.7 million and a charge for impairment of intangible assets of $25.0 million. For the second quarter of 2004, financial results included a charge for impairment of intangible assets of $17.2 million.  Excluding charges for restructuring and impairments, the loss on a non-GAAP basis for the second quarter of 2005 was $44.4 million, or $0.49 per share, compared to $43.4 million, or $0.49 per share, for the same period in 2004.

 

Net cash used in operating activities in the second quarter of 2005 was $24.3 million, compared to $37.3 million in the same quarter of 2004.  Cash, cash equivalents and marketable securities totaled approximately $378.0 million as of June 30, 2005.

 

“During the second quarter, we concluded our strategic review of programs and resources and now we are executing on the resulting strategy,” said Bill Ringo, president and chief executive officer of Abgenix.  “Considerable progress has

 

1



 

been made, including the consolidation of our research activities and commitment to retain and capitalize on our antibody manufacturing capability.  In addition, as we move forward with Amgen on the anticipated BLA submission for panitumumab, our lead product candidate, we have decided to co-promote panitumumab with an Abgenix sales organization in the U.S., data timing and outcome dependent.”

 

Revenues for the second quarter of 2005 were $3.4 million compared to $5.5 million for the same period in 2004.  Revenues for the second quarter of 2005 included contract revenues, which primarily consisted of fees from technology licensing agreements.  Revenues for the second quarter of 2004 also included manufacturing revenue for the production of an antibody candidate for an Abgenix partner.  The company’s contract revenues generally vary from period to period based on the success of research and development efforts by the company’s collaborators and licensees.

 

Operating expenses for the second quarter of 2005 were $86.8 million, which include special charges related to restructuring and impairment of intangible assets totaling $39.7 million.  Operating expenses for the same period in 2004 were $66.3 million, which included a special charge of $17.2 million for impairment of intangible assets.  Restructuring charges of $14.7 million in the second quarter of 2005 relate to the recently announced workforce reduction and consolidation of research facilities.  Those charges include $2.7 million in severance benefits and $12.0 million for the write-down of lease obligations and leasehold improvements.  The charge for impairment of intangible assets of $25.0 million in the second quarter of 2005 consists primarily of technology and intellectual property associated with the company’s Selected Lymphocyte Antibody Method (SLAM) technology.  Following the strategic review of its technology portfolio during the second quarter of 2005 and the recent development of additional proprietary methods, the company determined that the fair value of these intangible assets had fallen below their carrying value.  Excluding the special charges in both periods, overall operating costs remained at approximately the same level in the second quarter of 2005 compared to the second quarter of 2004.

 

Clinical Update

 

Abgenix is providing an update on a recently completed primary analysis of a randomized Phase 2 study conducted by its partner, Amgen.  That study compared a combination of panitumumab and standard chemotherapy with standard chemotherapy alone in the first line treatment of advanced non-small cell lung cancer.  When compared with chemotherapy alone, the panitumumab combination did not improve time to disease progression, the study’s primary efficacy endpoint. The combination of panitumumab and standard chemotherapy appeared to be generally well tolerated.  Further analysis of the data is ongoing.  Full safety and efficacy results are expected to be presented at a medical meeting later this year.

 

2



 

Second Quarter 2005 and Recent Company Highlights

 

                  Data presentations at 41st Annual Meeting of the American Society of Clinical Oncology (ASCO)

                  Results from an ongoing Phase 2 study demonstrated antitumor activity of panitumumab as a single-agent treatment in patients with metastatic colorectal cancer who have failed standard chemotherapy

                  Data from a Phase 1 open-label dose escalation trial of panitumumab supporting the antibody’s safety profile and possible flexibility of dosing schedule

 

                  Panitumumab development progress

                  Successful production of conformance lots of panitumumab in preparation for a possible BLA submission

                  Achieved data cut-off in panitumumab pivotal trial measuring progression free survival in the treatment of colorectal cancer patients who have failed standard chemotherapy regimens

                  Initiated the Panitumumab Advanced Colorectal Cancer Evaluation (PACCE) study evaluating panitumumab as a first line treatment of metastatic colorectal cancer in combination with chemotherapy and bevacizumab versus chemotherapy and bevacizumab alone

 

                  Proprietary and partner pipeline activities

                  Initiation of patient screening in a multiple dose Phase 1 study of ABX-PTH, Abgenix’s proprietary fully human antibody for the potential treatment of secondary hyperparathyroidism (SHPT)

                  Submission of an Investigational New Drug Application by Agensys, Inc. for AGS-PSCA, a fully human monoclonal antibody developed with XenoMouse® technology through a licensing arrangement with Abgenix

 

                  Completion of strategic review

                  Optimization of research and pre-clinical programs, including reduction of workforce and facility consolidation

                  Commitment to retain and support antibody manufacturing for production of panitumumab and other products

                  Decision to pursue panitumumab co-promotion arrangement with Amgen, contingent on pivotal data outcome

                  Enhanced leadership team, including the appointments of Michael Gallo, Ph.D., vice president of research; Gregory Yedinak, vice president of manufacturing and facilities; and Larry Green, Ph.D., senior research fellow

 

3



 

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 800-798-2884 fifteen minutes before the conference begins. International callers should dial 617-614-6207. The pass code is 58063402. The call also will be webcast live at www.abgenix.com. A replay of the call will be available until August 9, 2005, on the company’s website or by dialing 888-286-8010. International callers should dial 617-801-6888. The replay participant code is 30198294.

 

About Abgenix

 

Abgenix is a biopharmaceutical company focused on the discovery, development and manufacturing of human therapeutic antibodies. The company’s antibody development platform includes a leading technology and state-of-the-art manufacturing capabilities that enable the rapid generation, selection and production of high affinity, fully human antibody product candidates to a variety of disease targets. 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, 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 the success of clinical trials, the progress of research and product development programs, product manufacturing, regulatory 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-K.  Abgenix is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements.

 

(Tables follow.)

 

4



 

ABGENIX, INC.

CONSOLIDATED STATEMENT OF OPERATIONS DATA

(in thousands except per share data)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

Contract revenue

 

$

3,403

 

$

4,189

 

$

6,061

 

$

7,079

 

Contract manufacturing revenue

 

 

1,325

 

 

1,325

 

Total revenues

 

3,403

 

5,514

 

6,061

 

8,404

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Cost of goods manufactured

 

 

1,857

 

 

1,857

 

Research and development

 

35,545

 

36,148

 

71,329

 

64,605

 

Manufacturing start-up costs

 

4,807

 

2,790

 

6,784

 

10,136

 

General and administrative

 

5,264

 

6,477

 

10,967

 

13,365

 

Amortization of intangible assets

 

1,441

 

1,791

 

2,882

 

3,583

 

Impairment of intangible assets

 

25,000

 

17,241

 

25,000

 

17,241

 

Restructuring and other

 

14,740

 

 

14,740

 

 

Total operating expenses

 

86,797

 

66,304

 

131,702

 

110,787

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(83,394

)

(60,790

)

(125,641

)

(102,383

)

 

 

 

 

 

 

 

 

 

 

Other income (expenses):

 

 

 

 

 

 

 

 

 

Interest and other income

 

3,002

 

1,814

 

5,958

 

3,484

 

Interest expense

 

(3,725

)

(1,647

)

(7,067

)

(3,290

)

Total other income (expenses)

 

(723

)

167

 

(1,109

)

194

 

Net loss

 

$

(84,117

)

$

(60,623

)

$

(126,750

)

$

(102,189

)

Basic and diluted net loss per share

 

$

(0.94

)

$

(0.68

)

$

(1.42

)

$

(1.15

)

Shares used in computing basic and diluted net loss per share

 

89,658

 

88,673

 

89,456

 

88,490

 

 

5



 

ABGENIX, INC.

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

(in thousands except per share data)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss

 

$

(84,117

)

$

(60,623

)

$

(126,750

)

$

(102,189

)

Add: Impairment of intangible assets

 

25,000

 

17,241

 

25,000

 

17,241

 

 Restructuring and other

 

14,740

 

 

14,740

 

 

Non-GAAP net loss

 

$

(44,377

)

$

(43,382

)

$

(87,010

)

$

(84,948

)

Basic and diluted non-GAAP net loss per share

 

$

(0.49

)

$

(0.49

)

$

(0.97

)

$

(0.96

)

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

 

89,658

 

88,673

 

89,456

 

88,490

 

 


(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.

 

6



 

ABGENIX, INC.

CONSOLIDATED BALANCE SHEET DATA

(in thousands)

 

 

 

June 30,

 

December 31,

 

 

 

2005

 

2004

 

 

 

(unaudited)

 

*

 

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

 

$

378,003

 

$

416,329

 

Other current assets

 

12,176

 

19,187

 

Total current assets

 

390,179

 

435,516

 

Property and equipment, net

 

204,535

 

223,004

 

Long-term investments

 

16,287

 

23,300

 

Intangible assets, net

 

66,908

 

94,790

 

Deposits and other assets

 

35,073

 

36,108

 

Total assets

 

$

712,982

 

$

812,718

 

Deferred revenue

 

$

8,900

 

$

11,692

 

Accrued restructuring charges

 

3,637

 

 

Other current liabilities

 

19,701

 

23,257

 

Total current liabilities

 

32,238

 

34,949

 

Convertible notes

 

463,636

 

463,630

 

Deferred rent

 

7,354

 

7,519

 

Non-current portion of accrued restructuring charges

 

5,576

 

 

Other long-term liabilities

 

52,813

 

25,626

 

Redeemable convertible preferred stock

 

49,869

 

49,869

 

Stockholders’ equity

 

101,496

 

231,125

 

Total liabilities and stockholders’ equity

 

$

712,982

 

$

812,718

 

 


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

 

 

Contact Information

 

Greg Mann

Director, Corporate Communications and Investor Relations

Abgenix, Inc.

(510) 284-6566

Greg.Mann@abgenix.com

 

7


 

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