XOMA Reports 1998 Financial Results; Progress in
NEUPREX, hu1124 Product Development
BERKELEY, Calif.--(BW HealthWire)--Feb. 26, 1999--XOMA Ltd.
(Nasdaq:XOMA) today announced its financial results for 1998. The
Company's net loss for the year ended December 31, 1998, was $47.2
million ($1.16 per share), compared with $15.8 million ($0.44 per
share) in 1997. The year-to-year difference includes $21.9 million in
non-recurring items ($4.9 million of 1998 expenses related to XOMA's
change in legal domicile and in-licensing of BPI patents, and $17
million of 1997 revenue related to the sale of certain patents and
royalty rights).
Net cash used in operations in 1998 was $37.7 million; XOMA
finished the year with $28.3 million in cash and investments. In a
subsequent event, the Company completed a common stock private
placement financing in January 1999 that raised gross proceeds of $12
million. After this financing, XOMA has cash to meet currently
anticipated needs for 1999.
"1998 was a year of major investment in the clinical development
of NEUPREX(R) and hu1124," said Jack Castello, XOMA's chairman,
president and chief executive officer. "We are now close to completing
enrollment in our NEUPREX(R) Phase III pivotal trial in children with
severe meningococcemia. A second Phase III trial testing the product
in trauma patients is well underway. We also successfully concluded a
Phase II efficacy trial of hu1124 in moderate-to-severe psoriasis
patients. Finally, our change in legal domicile from Delaware to
Bermuda should position XOMA to improve our long-term financial
performance."
Change in Legal Domicile
At year-end 1998, XOMA completed a change in legal domicile from
Delaware to Bermuda. This reorganization, which was supported by 95%
of the votes cast by the Company's shareholders, is intended to
provide future tax and other benefits. The Company's research and
development, manufacturing and administrative facilities will continue
to operate in Berkeley and Santa Monica, CA.
Clinical Update
In 1998, XOMA was actively enrolling patients in two large Phase
III clinical trials of NEUPREX(R), the lead product from its BPI
(bactericidal/permeability-increasing protein) pharmaceutical
development platform.
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-- Enrollment continues in the Phase III pivotal trial in children
with severe meningococcemia. Upon the recommendation of an
independent Data Safety Monitoring Board (DSMB) that reviews the
progress of the study, enrollment has continued into 1999. The
Company currently expects to conclude the trial early in 1999,
following further guidance from the DSMB.
-- The second Phase III trial is testing NEUPREX(R) to prevent
serious pulmonary complications (pneumonia and acute respiratory
distress syndrome) in patients with hemorrhage due to trauma
(severe blood loss from injuries). Supported by Phase II studies
involving 570 patients, this double-blinded, placebo-controlled
pivotal trial is designed to enroll 1650 patients at
approximately 40 U.S. trial centers. Nearly 700 patients have
been enrolled in the Phase III trial, and the current estimate is
to complete trial enrollment by late this year or early next.
-- XOMA completed a Phase I (safety and pharmacokinetics) study
testing NEUPREX(R) in Cystic Fibrosis (CF) patients hospitalized
with pulmonary exacerbations of their chronic disease. The study
provided useful information about this patient population.
Further work in this area will be assessed after detailed review
with the Cystic Fibrosis Foundation.
-- In collaboration with Genentech, Inc., XOMA successfully
completed a Phase II trial testing the hu1124 antibody product in
patients with mild to severe psoriasis. XOMA received a $2
million milestone payment from Genentech in December 1998.
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XOMA Ltd. develops and manufactures recombinant protein
(including antibody) and peptide pharmaceuticals. Medical targets
include bacterial and fungal infections, infectious complications
(such as those that may follow trauma or surgery), and immunologic
disorders. XOMA's primary drug development platform is BPI
(bactericidal/permeability-increasing protein), a human host-defense
protein found in white blood cells that has multiple anti-infective
properties.
Statements made in this news release relating to the timing of
clinical trials, other aspects of product development or that
otherwise relate to future periods, are forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. These statements
are based on assumptions which may not prove accurate. Actual results
could differ materially from those anticipated due to risks inherent
in the biotechnology industry and for companies engaged in the
development of new products in a regulated market. These risks,
including results and timing of clinical trials, changes in the status
of the Company's collaborative relationships, uncertainties regarding
the legal standards applicable to biotechnology patents, actions by
the U.S. Food and Drug Administration or the U.S. Patent and Trademark
Office, and the Year 2000 issue, are discussed in the Company's most
recent annual report on Form 10-K, and in other SEC filings. Consider
such risks carefully in evaluating XOMA's prospects.
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XOMA CORPORATION
CONDENSED BALANCE SHEETS
(in thousands)
December 31 December 31
1998 1997
Assets:
Cash and cash equivalents $ 11, 857 $ 37,225
Short-term investments 16,430 17,921
Notes and other receivables 390 351
Other current assets 159 142
--------- --------
Total current assets 28,836 55,639
Property and equipment, net 3,895 4,564
Assets held for sale 4,442 4,442
Other assets 131 131
--------- --------
$ 37,304 $ 64,776
========= ========
Liabilities and Stockholders' Equity:
Accounts payable $ 3,515 $ 1,644
Other liabilities 7,026 7,119
--------- --------
Total current liabilities 10,541 8,763
--------- --------
Convertible notes 26,513 24,773
--------- --------
Stockholders' equity 250 31,240
--------- --------
$ 37,304 $ 64,776
========= ========
XOMA CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(in thousands except per share data)
Three Months Ended Year Ended
December 31 December 31
1998 1997 1998 1997
Revenues:
License fees $ 3,500 $ 17,100 $ 4,318 $ 18,077
Collaborative
agreements 2,000 179 2,000 250
Product sales and
royalties 6 12 27 56
-------- -------- -------- --------
Total revenues 5,506 17,291 6,345 18,383
-------- -------- -------- --------
Expenses:
Research and
development 11,254 7,518 43,839 29,878
General and
administrative 1,434 1,283 5,430 5,674
Non-recurring
expenses 2,515 -- 4,915 --
-------- -------- -------- --------
Total operating
expenses 15,203 8,801 54,184 35,552
-------- -------- -------- --------
(Loss) Income from
operations (9,697) 8,490 (47,839) (17,169)
Other Income
(Expense):
Investment income 421 502 2,269 2,120
Interest expense
and other (348) 63 (1,633) (716)
-------- -------- -------- --------
Net income/(loss) (9,624) 9,055 (47,203) (15,765) |
