ABGX beats estimates by three pennies, though this may be a non-event compared to upside on the clinical front:
>>FREMONT, Calif., Jan 29, 2002 (BW HealthWire) -- Abgenix, Inc. (NASDAQ: ABGX chart, msgs) today reported financial results for the fourth quarter and year ended December 31, 2001.
For the year ended December 31, 2001, the company reported a net loss of $60.9 million or $0.71 per share, compared to a net loss of $8.8 million or $0.11 per share for the year ended December 31, 2000. Contract revenues for 2001 increased to $34.1 million from $26.6 million in 2000. Including interest income, total revenues for the year 2001 increased to $63.6 million from $59.4 million in 2000. These revenues did not include certain non-refundable payments received from corporate partners that were recorded as deferred revenue. Deferred revenue totaled $11.8 million as of December 31, 2001, up from $7.0 million at December 31, 2000.
Research and development expenses for 2001 increased to $96.2 million from $50.1 million in 2000 due to an increased level of clinical development of our existing product candidates, as well as increased research and development to validate new product candidates, supported by an increase in headcount from 174 to 327 employees.
Abgenix ended the year with approximately $558 million in cash, cash equivalents and marketable securities.
For the quarter ended December 31, 2001, the company reported a net loss of $15.8 million or $0.18 per share, compared to a net loss of $4.5 million or $0.05 per share in the same period of 2000. Contract revenues for the fourth quarter in 2001 were $17.5 million compared to $13.5 million in the same period of 2000. Including interest income, total revenues in the fourth quarter were $22.7 million versus $24.0 million in the fourth quarter of 2000.
"Our significant accomplishments in 2001 reflect our commitment to the development of Abgenix proprietary products," stated R. Scott Greer, chairman and chief executive officer of Abgenix. "In particular, we are very pleased with the progress of our clinical pipeline, including the initiation of a number of new trials for ABX-IL8 and ABX-EGF, and the introduction of two new antibodies derived from our technology, ABX-MA1, which Abgenix is developing, and a product candidate which Amgen is developing. We believe we are well-positioned to achieve our goal of becoming a prolific provider of biopharmaceutical candidates with our core product generation capability, our access to exciting and novel targets, our strong management team and a solid balance sheet."
Highlights and Accomplishments:
Fourth quarter 2001 company highlights included:
-- Acquiring rights from Gliatech to antibodies against the
complement protein properdin. An anti-properdin antibody may
be a potential treatment for cardiovascular or inflammatory
disease and may be one of the two product candidates for which
the company plans to file Investigational New Drug (IND)
applications in 2002;
-- Acquiring Hesed, a private biotechnology company with
intellectual property and technology in the field of catalytic
antibodies, which have the potential to dramatically lower
cost of goods;
-- Acquiring rights to the EGFrvIII cancer target, a mutant form
of the epidermal growth factor receptor (EGFr). The EGFrvIII
target is expressed only on cancer tissue and may be a more
specific target for antibody-based therapies;
-- The launch of new versions of XenoMouse(R) mice that produce
fully human antibodies that contain both lambda and kappa
light chains, in order to capture the human antibody response
more completely than the other transgenic mouse technologies
in the commercial sector, which lack the lambda light chain
from which approximately 40% of human antibodies are made;
-- Announcing a plan for Dr. Ray Withy, currently President and
Chief Operating Officer, to succeed Scott Greer as CEO around
mid-2002. Mr. Greer will continue to serve as Chairman of the
Board.
-- Starting a Phase II clinical trial of ABX-EGF as monotherapy
in second-line colorectal cancer patients; and,
-- Filing an IND for a new Abgenix proprietary product, ABX-MA1,
a fully human monoclonal antibody generated from XenoMouse
technology for the treatment of metastatic melanoma.
In addition to these achievements in 2001, the company recently announced the filing of an IND to initiate clinical trials of ABX-IL8 in a wide variety of cancers. The first cancer indication will be metastatic melanoma, in a Phase II trial. ABX-IL8 continues to be studied in inflammatory diseases including psoriasis and COPD. In addition, the company, along with co-development partner Immunex, initiated two additional Phase II trials for ABX-EGF, in prostate cancer and first-line colorectal cancer, for a total of five Phase II trials in the diversified clinical program for ABX-EGF.
Outlook:
The following statements are based on current goals. These statements are forward-looking, and actual results may differ materially from those described in these statements. For a discussion of the important risk factors that may cause such a difference, please refer to our Form S-1 registration statement filed recently with the SEC.
We expect 2002 to be another year of significant growth for Abgenix. Abgenix is developing four product candidates in clinical trials for ten indications. In addition, we plan to file INDs on two new proprietary Abgenix product candidates, and expect to end 2002 with six product candidates in clinical trials in twelve indications. To support these clinical trials, we plan to increase our headcount and expenditures in the areas of clinical development and regulatory affairs. In addition, as our manufacturing facility becomes operational by the end of the year, we expect to increase headcount in the areas of process sciences, manufacturing, quality assurance and quality control. We also expect the research organization to grow to validate new product candidates resulting from our increased access to novel targets. Overall, Abgenix expects R&D expenses to range between $155 and $170 million and SG&A expenses to range between $20 and $25 million in 2002 with headcount expected to grow from 327 to between 600 to 700 during 2002.
We expect contract revenues to rise to the $40 to $45 million level in 2002, with approximately $8 to $10 million of this to be recorded in the first quarter, a further 60% to 70% of the year's total revenue to be recorded in the fourth quarter, and the balance to be recorded in the second and third quarters. Interest income is expected to be between $10 to $15 million. Depreciation is expected to be approximately $15 million. Therefore, the company's 2002 target loss, before depreciation and amortization of intangibles, is $105 to $120 million. We begin 2002 with approximately $558 million in cash, cash equivalents and marketable securities.
We plan to continue evaluating acquisition opportunities that would enhance shareholder value. Depending on the nature and size of any acquisitions completed, the preceding estimates could be altered. We undertake no obligation to update the public as our expectations change.
Abgenix plans to achieve the following milestones in 2002:
-- Report Phase II clinical trial results of ABX-EGF in renal
cell cancer at ASCO in May; Report Phase IIb clinical trial
results of ABX-IL8 in psoriasis around mid-year; Complete a
Phase IIa clinical trial of ABX-IL8 in COPD;
-- Complete enrollment in a Phase II/III clinical trial of
ABX-CBL in Graft Versus Host Disease;
-- File INDs on two new Abgenix proprietary product candidates;
-- Announce three new product IND filings by licensees;
-- Establish a collaboration to co-develop and commercialize
ABX-IL8;
-- Establish antibody technology license collaborations covering
up to ten new products; and
-- Establish additional target and technology access
collaborations.
Abgenix will hold a conference call at 5:30 PM EST on January 29, 2002 to discuss these financial results. Interested parties may listen to the call by dialing 800-479-9001 and mentioning the "Abgenix Conference Call". A replay of the call will be available starting at 9 PM EST on January 29, 2002 through 11 PM EST on February 12, 2002. To listen to the replay, dial 888-203-1112 and enter the replay access code 426375 when prompted.
Abgenix is a biopharmaceutical company focused on the development and commercialization of human therapeutic antibodies. The company's technology platform, which includes XenoMouse(R) and XenoMax(TM) technologies, enables the rapid generation and selection of high affinity, fully human antibody product candidates to a variety of disease targets. Abgenix leverages its leadership position in human antibody technology by building a diversified product portfolio through the development of its own internal proprietary products and through the establishment of licensing arrangements with multiple pharmaceutical, biotechnology and genomics companies. Abgenix's proprietary products are currently in clinical trials for the treatment of cancer and inflammatory diseases. For more information on Abgenix, visit the company's website at www.abgenix.com.
The forward-looking statements in this press release and in our conference call express our goals and expections as of the date of this press release and the conference call, respectively. We undertake no obligation to update these statements even if our goals and expectations change from time to time. The posting of this press release on our website and the replay availability of the conference call do not imply that the statements herein or therein remain an accurate reflection of our goals and expectations at any time subsequent to their respective original dates.
Statements made in this press release about Abgenix's financial goals for 2002, product development activities and collaborative arrangements, 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, the regulatory approval process, competitive products, 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.
Three Months Ended Twelve Months Ended
CONSOLIDATED STATEMENT OF December 31, December 31,
OPERATIONS DATA 2001 2000 2001 2000
------------------- -------------------
(in thousands except
per share data) (unaudited) (unaudited) (a)
Revenues:
Contract revenues $17,461 $13,524 $34,064 $26,601
Interest and other income 5,279 10,513 29,542 32,848
------------------- ------------------
Total revenues 22,740 24,037 63,606 59,449
Costs and Expenses:
Research and development 31,045 18,951 96,234 50,137
General and administrative 5,088 2,982 19,367 8,859
Amortization of
intangible assets 2,390 1,663 8,602 3,992
In-process R&D charge - 5,215 - 5,215
Interest and other expense
(income), net 2 (278) 259 39
------------------- ------------------
Total costs and expenses 38,525 28,533 124,462 68,242
------------------- ------------------
Net loss ($15,785) ($4,496) ($60,856) ($8,793)
=================== ==================
Basic and diluted
net loss per share ($0.18) ($0.05) ($0.71) ($0.11)
=================== ==================
Shares used in computing
basic and diluted
net loss per share 86,658 83,879 86,111 80,076
=================== ==================
December 31, December 31,
CONSOLIDATED BALANCE SHEET DATA 2001 2000
-----------------------------------
(in thousands) (unaudited) (a)
Cash, cash equivalents
and marketable securities $557,813 $772,064
Other current assets 21,905 25,155
-------- --------
Total current assets 579,718 797,219
Property and equipment, net 86,467 18,374
Long-term investments 15,039 --
Intangible assets, net 134,306 117,997
Deposits & other assets 22,346 3,210
-------- --------
Total assets $837,876 $936,800
======== ========
Deferred revenue $ 11,751 $ 6,978
Other current liabilities 30,919 14,151
Acquisition liabilities 2,158 75,429
-------- --------
Total current liabilities 44,828 96,558
Deferred rent 2,078 567
Stockholders' equity 790,970 839,675
-------- --------
Total liabilities and
stockholders' equity $837,876 $936,800
======== ========
Note (a): Derived from the December 31, 2000 audited financial statements.<<
Cheers, Tuck |
