Year of Achievement Paves Way for Future as Top-Tier Biotechnology Company
SUNNYVALE, Calif., Feb. 7 /PRNewswire-FirstCall/ --
Scios Inc. (Nasdaq: SCIO) announced today its full fourth quarter and year-end
financial results for 2001.
Scios previously reported that net sales for its lead product Natrecor(R)
(nesiritide) for the year ended 2001 were $14.1 million. Based on this strong
start, Scios raised its full year 2002 net sales outlook for Natrecor to
$55 to $60 million.
"2001 was a defining year in the company's history marked by a series of
achievements that pave the way for a very exciting future as a top-tier
biotechnology company," said Richard B. Brewer, Scios' president and chief
executive officer. "We gained FDA approval for and launched Natrecor, the
first new drug for acute congestive heart failure in over a decade; we hired
and trained a focused hospital-based sales force led by highly experienced
sales management; we signed a licensing agreement with GlaxoSmithKline to
commercialize Natrecor in Europe; we advanced SCIO-469 into the clinic, and
our soon to begin Phase IIa study places us at the forefront of development of
an oral anti-inflammatory agent for rheumatoid arthritis based on p38 kinase
inhibition."
"In addition to these accomplishments, our research group has developed
several back-up molecules to SCIO-469, and rapidly advanced another new
product candidate through preclinical development, the details of which we
will announce at the SG Cowen Healthcare Conference in March," added
Mr. Brewer.
Fourth Quarter and Year End Financial Results
Fourth quarter 2001 net revenues were $10.5 million compared to
$3.5 million in the fourth quarter of 2000. This increase was primarily due
to Natrecor product revenue. In the prior year the Company had $2.4 million
in product sales related to the psychiatric sales and marketing division,
which ceased operations in the first quarter of 2001.
Total costs and expenses for the fourth quarter of 2001 were $40.7 million
compared to $16.0 million in the fourth quarter of 2000. The increase in
costs and expenses was largely attributable to building a marketing and sales
infrastructure for Natrecor and clinical development of the p38 kinase
inhibitor program.
Net loss for the quarter was $28.8 million, or $0.63 per diluted share,
compared to a net loss of $12.2 million, or $0.32 per diluted share, for the
same period last year. Per share amounts were based on 45.7 million weighted
average diluted shares in the 2001 fourth quarter, compared to 38.6 million
weighted average diluted shares in last year's quarter.
Net revenues for the year ended 2001 were $47.3 million compared to
$12.6 million in the same period last year. The 2001 increase was primarily
due to the following: one-time sale of bulk FGF to Kaken for $15.9 million;
one-time gain from the sale of marketing rights to GlaxoSmithKline in the
amount of $9.4 million related to the psychiatric sales and marketing
division; and $14.1 million of Natrecor product revenue. In 2001, sales from
the psychiatric sales and marketing division were $3.1 million, and in 2000,
sales were $6.9 million.
Total costs and expenses for 2001 were $112.5 million compared to
$55.0 million for the same period a year ago. The increase in costs and
expenses for the year is largely attributable to building a marketing and
sales infrastructure for Natrecor and development of the p38 kinase inhibitor
program.
The Company reported a net loss of $62.5 million, or $1.47 per diluted
share, for the year ended December 31, 2001, compared to a net loss of
$42.5 million, or $1.12 per diluted share, for the comparable period in 2000.
Cash, cash equivalents and marketable securities (both current and
non-current) balances at December 31, 2001 were $129.3 million.
Key 2001 Achievements:
-- Filed New Drug Application amendment to FDA for Natrecor;
-- Completed Phase I clinical program for SCIO-469;
-- Built internal sales and marketing team and infrastructure to launch
Natrecor;
-- Recruited, hired and trained sales force to launch and sell Natrecor in
the U.S.;
-- Raised additional $114 million in cash through public stock offering;
-- Received FDA approval to market Natrecor;
-- Launched Natrecor one business day after receiving FDA approval;
-- Achieved better than expected Natrecor sales;
-- Launched ADHERE, the first national acute heart failure registry, with
nearly 2,000 patients enrolled to date;
-- Filed Investigational New Drug Application with FDA for SCIO-469 to
begin Phase II clinical trial program;
-- Signed licensing agreement with GlaxoSmithKline for commercialization
of Natrecor in Europe;
In addition to increasing sales of Natrecor in the acute heart failure
market, Scios is evaluating additional opportunities for the product. During
the fourth quarter of 2001, Scios began enrolling patients in a pilot study,
called FUSION, designed to evaluate the safety and tolerability of Natrecor
when administered in an outpatient setting to patients with chronic advanced
congestive heart failure who are at high risk for hospitalization.
Following the successful completion of two Phase I studies in England,
Scios filed an Investigational New Drug application to begin clinical studies
in the United States of SCIO-469, its novel oral p38 kinase inhibitor for the
treatment of Rheumatoid Arthritis (RA). The Company expects to begin a Phase
IIa clinical trial evaluating SCIO-469 later this month. The trial will
enroll 120 RA patients and is expected to be completed by the end of 2002.
Safety data and preliminary efficacy data from this study are expected to be
announced in early 2003.
The company also announced that Dr. Donald Rice, Scios' Chairman of the
Board, will take a more active role working with the senior management team as
Mr. Brewer completes the next phase of his treatment for multiple myeloma,
which is expected to last up to approximately two months. For this interim
period, the Board of Directors has established the Office of the Chairman,
composed of Dr. Rice and the senior management team.
Dr. Rice has served as Chairman of the Scios Board of Directors since
1998, and is currently the President and CEO of Agensys, Inc. Dr. Rice is
also a Board member of Amgen, Inc., Wells Fargo & Company, Unocal Corporation
and Vulcan Materials Company.
"Dr. Rice has expertly led our Board over the past few years and I am
pleased he will be overseeing operations in my temporary absence during which
I expect to be in close contact with him and the rest of the senior management
team," added Brewer.
Webcast and Conference Call Details
Investors can access a live webcast of the fourth quarter earnings
conference call through a link that will be posted on the investor page of the
Scios website, http://www.sciosinc.com. The conference call begins at 8:00 a.m.
Pacific Standard Time on Thursday, February 7th and will be available for one
week for replay.
To access the conference call, dial 800-364-4174 (domestic) / 706-634-5159
(international) with passcode 2870735. For those unable to listen to the live
events, the webcast will be archived for 15 business days following the event.
A replay of the conference call will be available by dialing 800-642-1687
(domestic) / 706-645-9291 (international) with passcode 2870735 beginning
approximately 2 hours after the event and last through February 14, 2002.
Scios Inc.
Scios is a biopharmaceutical company developing novel treatments for
cardiovascular and inflammatory disease. The Company's disease-based
technology platform integrates expertise in protein biology with computational
and medicinal chemistry to identify novel targets and rationally design small
molecule compounds for large markets with unmet medical needs.
Forward-Looking Safe Harbor Statement
This news release contains 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. We generally identify such forward-looking statements
using words like "believe," "intend," "expect," "may," "should," "plan,"
"project," "contemplate," "anticipate" or similar statements. Statements
that are not historical facts are forward-looking statements based on current
assumptions that involve risks and uncertainties. These risks and
uncertainties may include the sales penetration and success of Natrecor, the
success of clinical trials of Natrecor and our pipeline products, including
SCIO-469, as well as other risks detailed from time to time in the reports
filed by Scios with the SEC, including the Company's quarterly reports and
annual report on Form 10-K. Actual results, performance or achievements of
Scios may differ significantly from those described in these forward-looking
statements. Scios disclaims any intention or obligation to update or revise
any financial projections or forward-looking statements, whether as a result
of new information, future events or otherwise.
SCIOS INC.
Consolidated Condensed Balance Sheets
(In thousands, except share data)
December 31, December 31,
2001 2000
ASSETS
Current assets:
Cash and cash equivalents $58,296 $3,291
Marketable securities 7,351 35,356
Accounts receivable, net 6,943 5,217
Inventory 1,158 --
Prepaid expenses and other assets 4,214 722
Total current assets 77,962 44,586
Marketable securities, non-current 63,669 32,884
Property and equipment, net 10,424 8,910
Other assets 4,123 2,007
TOTAL ASSETS $156,178 $88,387
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $9,625 $4,587
Accrued employee compensation 7,346 2,765
Other accrued liabilities 9,545 7,984
Deferred contract revenue -- 16,193
Short term debt 33,035 --
Total current liabilities 59,551 31,529
Long-term obligations 15,479 39,095
Total liabilities 75,030 70,624
Total stockholders' equity 81,148 17,763
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $156,178 $88,387
SCIOS INC.
Consolidated Condensed Statements of Operations
(In thousands, except share and per share data)
Three months ended Twelve months ended
December 31, December 31,
2001 2000 2001 2000
(Unaudited)
Revenues:
Product sales $9,624 $-- $30,052 $--
Research & development
contracts and royalties 923 1,142 4,788 5,710
Psychiatric product sales,
co-promotion
commissions, net of expenses -- 2,375 3,142 6,914
Gain on sale of marketing
rights -- -- 9,363 --
10,547 3,517 47,345 12,624
Costs and expenses
Cost of sales/research
and development 13,346 9,055 50,046 39,278
Marketing, general
and administration 27,370 6,934 62,475 16,711
Restructuring charges
(credits) -- -- -- (993)
40,716 15,989 112,521 54,996
Loss from operations (30,169) (12,472) (65,176) (42,372)
Other income and expense:
Interest income 1,386 965 4,869 4,774
Interest expense (562) (869) (2,818) (3,796)
Realized gains (losses)
on securities 255 35 849 (152)
Other income (expense),
net 256 137 (221) (976)
1,335 268 2,679 (150)
Net loss $(28,834) $(12,204) $(62,497) $(42,522)
Loss per common share:
Basic and diluted $(0.63) $(0.32) $(1.47) $(1.12)
Weighted average
number of
common shares
outstanding
used in per share
calculation 45,730,836 38,617,475 42,623,093 37,997,872
SOURCE Scios Inc.
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Related links:
http://www.sciosinc.com
CONTACT:
David Gryska of Scios Inc., +1-408-616-8303,
or Jim Weiss of WeissCom Partners, Inc., +1-415-203-0328, for
Scios Inc.
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