Onyx Pharmaceuticals, Inc. (MM) (NASDAQ:ONXX)
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Onyx Pharmaceuticals Reports Fourth Quarter and Year-End 2003 Financial Results
RICHMOND, Calif., Feb. 12 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc.
reported a net loss of $11.8 million, or $0.40 per share, for the fourth quarter
ended December 31, 2003 compared with a net loss of $13.3 million, or $0.62 per
share, for the same quarter in 2002. During the fourth quarter of 2003, Onyx
reported restructuring costs of $1.4 million related to its previously announced
discontinuation of thecompany's therapeutic virus program. Without the
restructuring charge, the results would show a non-GAAP net loss of $10.4
million, or $0.35 per share, for the fourth quarter of 2003.
As of December 31, 2003, the company had cash, cash equivalents and marketable
securities of $105.4 million compared to $39.8 million at December 31, 2002. The
increase in cash balances resulted primarily from financing activities. In
February 2003, Onyx raised $10.0 million in a private placement of its common
stock. In July 2003, the company raised net proceeds of $73.7 million in a
public offering of 5,179,000 shares of its common stock at $15.25 per share. In
the fourth quarter of 2003, the company received a $15.0 million creditable
milestone-based payment from its collaborator, Bayer Pharmaceuticals
Corporation, upon the initiation of a Phase III clinical trial for its
investigational drug, BAY 43-9006. Subsequently in 2004, the company announced
that it raised net proceeds of $146.6 million in a public offering of 4,637,000
shares of its common stock at $33.75 per share.
"2003 was an important year for Onyx as we realigned our resources around the
development of BAY 43-9006," said Hollings C. Renton, the company's president
and chief executive officer. "With our collaborator Bayer, we began a pivotal
Phase III clinical trial for the treatment of patients with advanced kidney
cancer and reported encouraging preliminary results administering BAY 43-9006 --
both as a single agent and in combination with standard chemotherapeutics. In
2004, we look forward to expanding the number of clinical trials, as well as to
providing updates on the growing body of clinical data."
For the quarters ended December 31, 2003 and 2002, Onyx reported no revenue.
Research and development costs decreased by $3.2 million in the fourth quarter
of 2003 versus the comparable period last year. This was the result of
decreased expenses associated with the therapeutic virus program, partially
offset by increased expensesrelated to the development of BAY 43-9006. During
the fourth quarter of 2003, Onyx recorded $1.4 million of restructuring expenses
related to the discontinued use of a portion of its leased facilities and the
disposal of certain property and equipment. Total operating costs decreased to
$12.1 million in the fourth quarter of 2003, or $10.7 million on a non-GAAP
basis, from $13.4 million in the comparable period last year.
Full-year Results
For the year ended December 31, 2003, the company reported a net loss of $45.0
million, or $1.73 per share, compared with a net loss of $45.8 million, or $2.23
per share, for 2002. There were no revenues recorded in 2003 as compared to
$2.7 million recognized in 2002. The 2002 revenue reflected research funding
received from Warner-Lambert, a subsidiary of Pfizer Inc, for the therapeutic
virus collaboration that concluded in September 2002. Operating expenses
decreased by $4.3 million in 2003 as compared to 2002. This change was due to
the termination of the company's virus program, offset by increases in clinical
development costs associated with BAY 43-9006 and restructuring expenses.
For the year ended December 31, 2003, the company recorded $5.5 million of
restructuring expenses including $2.5 million related to terminating the XOMA
process development and manufacturing agreement, $1.6 million related to
severance costs, and $1.4 million related to the discontinued use of a portion
of Onyx's leased facilities and the disposal of certain property and equipment.
In addition, the company recorded $1.1 million for milestone payments to XOMA
prior to the termination of the previously mentioned agreement. Without the
restructuring charges and milestone payments, the results would show a non-GAAP
net loss of $38.3 million, or $1.48 per share, for the year ended December 31,
2003.
Onyx believes that the non-GAAP results in this release provide useful
information to investors, as they exclude the effects of non-recurring costs
related to restructuring that the company believes are not indicative of its
ongoing operations. The non-GAAP information is provided as a complement to
results provided in accordance with GAAP and should not be considered superior
to, or as a substitute for, GAAP measures. The differences in GAAP and non-GAAP
numbers are reconciled in the attached tables.
Onyx Pharmaceuticals is engaged in the development of novel cancer therapies and
has proprietary technologies that target the molecular basis of cancer. With
its collaborators, the company is developing small molecule drugs, including BAY
43-9006 in codevelopment with Bayer Pharmaceuticals Corporation. For more
information about Onyx's pipeline and activities, visit the company's web site
at http://www.onyx-pharm.com/.
This news release contains forward-looking statements regarding expectations
about the development of BAY 43-9006, including further clinical testing and the
timing of such clinical trials; and the company's expectations or beliefs of the
commercial potential of BAY 43-9006. These forward-looking statements involve a
number of risks and uncertainties that could cause actual events to differ from
the company's expectations. These risks are addressed in the company's periodic
reports filed with the Securities and Exchange Commission, including but not
limited to its Annual Report on Form 10-K filed on March 25, 2003 and its
Quarterly Reports on Form 10-Q.
ONYX PHARMACEUTICALS, INC.
SUMMARY FINANCIAL INFORMATION
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
Three Months Ended
December 31,
2003 2002
GAAP (1) Adjustments Non-GAAP (2) GAAP
Total revenue $-- $-- $-- $--
Operating expenses:
Research and
development 8,541 -- 8,541 11,765
General and
administrative 2,142 -- 2,142 1,655
Restructuring 1,385 (1,385)(3) -- --
Total operating expenses 12,068 (1,385) 10,683 13,420
Loss from operations (12,068) 1,385 (10,683) (13,420)
Interest income, net 272 -- 272 223
Other income (expense) -- -- -- (100)
Net loss $(11,796) $1,385 $(10,411) $(13,297)
Basic and diluted
net loss per share ($0.40) ($0.35) ($0.62)
Shares used in
computing basic
and diluted net
loss per share 29,400 29,400 21,595
(1) Reflects operating results in accordance with accounting principles
generally accepted in the United States (or U.S. GAAP).
(2) Non-GAAP amounts exclude restructuring costs.
(3) Amount represents restructuring costs for the discontinuation of the
company's therapeutic virus program related to the discontinued use
of a portion of its leased facilities and the disposal of certain
property and equipment.
ONYX PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share data amount)
(unaudited)
Year Ended
December 31,
2003 2002
GAAP (1) Adjustments Non-GAAP (2) GAAP
Total revenue $-- $-- $-- $2,715
Operating expenses:
Research and
development 33,638 (1,100)(3) 32,538 43,792
General and
administrative 6,360 -- 6,360 6,004
Restructuring 5,530 (5,530)(4) -- --
Total operating
expenses 45,528 (6,630) 38,898 49,796
Loss from
operations (45,528) 6,630 (38,898) (47,081)
Interest income, net 834 -- 834 1,159
Other income
(expense) (275) -- (275) 135
Net loss $(44,969) $6,630 $(38,339) $(45,787)
Basic and diluted
net loss per share ($1.73) ($1.48) ($2.23)
Shares used in
computing basic
and diluted net
loss per share 25,953 25,953 20,535
(1) Reflects operating results in accordance with accounting principles
generally accepted in the United States (or U.S. GAAP).
(2) Non-GAAP amounts exclude restructuring costs and milestone payments
to XOMA related to the company's process development and
manufacturing agreement that was terminated as a result of the
therapeutic virus program discontinuation announced in June 2003.
(3) Amount represents milestone payments to XOMA related to the
terminated process development and manufacturing agreement.
(4) Amount represents restructuring costs related to the January 2003
reduction in force and the discontinuation of the therapeutic virus
program announced in June 2003.
ONYX PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEET
(in thousands)
December 31, December 31,
2003 2002
(unaudited) (1)
Assets
Cash, cash equivalents and
marketable securities $105,400 $39,833
Other current assets 3,045 1,351
Total current assets 108,445 41,184
Property and equipment, net 285 2,834
Other assets 408 2,223
Total assets $109,138 $46,241
Liabilities and stockholders' equity
Current liabilities $15,619 $12,457
Advance from partner 20,000 5,000
Stockholders' equity 73,519 28,784
Total liabilities and
stockholders' equity $109,138 $46,241
(1) Derived from the audited financial statements included in the
Company's Annual Report on Form 10-K for the year ended December 31,
2002
DATASOURCE: Onyx Pharmaceuticals, Inc.
CONTACT: Julie Wood, +1-510-262-8757, for Onyx Pharmaceuticals, Inc.
Web site: http://www.onyx-pharm.com/