FREMONT, Calif., Oct. 25 /PRNewswire-FirstCall/ -- 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(R)-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.
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(R) (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.
-- 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 http://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.
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 http://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-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.
ABGENIX, INC. Three Months Ended Nine Months Ended
CONSOLIDATED STATEMENT OF September 30, September 30,
OPERATIONS DATA 2005 2004 2005 2004
(in thousands except (unaudited) (unaudited)
per share data)
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. Three Months Ended Nine Months Ended
RECONCILIATION OF September 30, September 30,
GAAP NET LOSS TO 2005 2004 2005 2004
NON-GAAP NET LOSS (1) (unaudited) (unaudited)
(in thousands except
per share data)
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. September 30, December 31,
CONSOLIDATED BALANCE SHEET DATA 2005 2004
(in thousands) (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.
SOURCE Abgenix, Inc.
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Related links:
http://www.abgenix.com
CONTACT:
Greg Mann, Director, Corporate Communications
& Investor Relations, +1-510-284-6566
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