Natrecor FDA Pre-approval Inspection Completed
Sales Force Ready to Launch
SUNNYVALE, Calif., July 26 /PRNewswire/ -- Scios, Inc. (Nasdaq: SCIO)
today announced financial results for the second quarter and six-month period
ended June 30, 2001. Scios also updated investors on the progress made with
the Company's lead product, Natrecor(R) (nesiritide). As previously
announced, Scios has received an approvable letter from the U.S. Food and Drug
Administration (FDA) for Natrecor, and Scios has been notified that the
Natrecor New Drug Application has been recommended for approval by the
San Francisco District Office of the FDA following their pre-approval
inspection.
"Our progress this quarter was among the most important in the company's
history," said Richard B. Brewer, Scios' president and chief executive
officer. "The FDA's Cardiovascular and Renal Drugs Advisory Committee
unanimously recommended approval of Natrecor; the FDA issued an approvable
letter for the drug; and the agency completed its pre-approval inspection. In
addition, we raised more than $100 million, significantly strengthening our
financial position and giving us the financial flexibility to launch and
market Natrecor while developing our promising pipeline, most importantly our
p38 kinase inhibitor for rheumatoid arthritis."
The company announced that it is nearing completion of recruitment of a
170-person sales force to launch Natrecor in the third quarter of this year.
To date, 153 Cardiovascular Specialists have been hired.
Second Quarter and First Six-Month Financial Results.
Net revenues for the second quarter were $5.2 million compared to
$3.1 million in the same period last year. This increase was largely due to
$2.1 million from the Company's sale of bulk Fibroblast Growth Factor ("FGF")
to Kaken following the approval of Kaken's Fiblast(R) Spray in Japan. Total
costs and expenses were $23.4 million in the second quarter compared to
$13.1 million for the year ago period. The increase in costs and expenses for
the quarter is primarily attributable to the costs associated with building a
marketing and sales infrastructure for Natrecor commercialization. The
company reported a net loss of $18.3 million, or $0.46 per diluted share,
compared to a $10.3 million net loss, or $0.27 per diluted share, in last
year's second quarter. Per share amounts were based on 40.1 million weighted
average diluted shares in the 2001 second quarter compared to 37.8 million
weighted average diluted shares in last year's second quarter.
Cash, cash equivalents and marketable securities (both current and
non-current) balances at June 30, 2001 increased to $164.2 million, an
increase from the first quarter of $102.1 million as a result of the
successful secondary offering.
Net revenues for the first six months of 2001 were $17.2 million compared
to $6.3 million in the same period last year. The increase was primarily due
to the sale of bulk FGF to Kaken of $2.1 million, and a 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. Total costs and
expenses in the six-month period were $39.3 million, compared to $25.8 million
for the year ago period. The company reported a net loss of $22.5 million in
the first six months of 2001, or $0.57 per diluted share, compared to a
$19.8 million net loss, or $0.52 per diluted share in last year's first six
months.
Pipeline Update
Scios also announced that the first patient was enrolled in Scios'
recently announced collaborative clinical trial with Medtronic, Inc.
(NYSE: MDT). The pilot clinical trial is designed to study the effects of
Natrecor in combination with Medtronic's Chronicle(R) Implantable Hemodynamic
Monitor (IHM). This first pilot clinical study is taking place at the
Karolinska Institute in Stockholm, Sweden.
Scios plans to begin a Phase II clinical trial for SCIO-469 in patients
with Rheumatoid Arthritis (RA) in the fourth quarter of this year. The
Phase II study will be a multi-center clinical study conducted in the United
States following the submission of an Investigational New Drug ("IND")
application to the U.S. Food and Drug Administration in the fourth quarter of
this year.
Today's Conference Call Details
As previously announced, Scios will host its customary quarterly
conference call today at 7:00 a.m. PT / 10:00 a.m. ET to discuss the results
of the second quarter of 2001 and the company's outlook. The dial-in number
is 800-474-8920. The call will also be broadcast live and archived on Scios'
web site at http://www.sciosinc.com until August 3, 2001.
Scios Inc.
Scios is a biopharmaceutical company developing novel treatments for heart
failure and rheumatoid arthritis. The Company's disease-based technology
platform integrates expertise in protein biology with combinatorial and
medicinal chemistry to identify novel targets and rationally design
protein-based and small-molecule compounds to treat cardiovascular and
inflammatory diseases. Additional information about Scios is available at its
web site located at http://www.sciosinc.com and in the Company's various filings with
the Securities and Exchange Commission (SEC).
Forward Looking Safe Harbor Disclaimer
The statements in this press release that are not historical facts are
forward-looking statements that involve risks and uncertainties. These
include uncertainties associated with the timing of final regulatory approval
of Natrecor, the sales penetration and success of Natrecor, the timing of the
IND filing for SCIO-469 and successful completion of additional studies, as
well as other risks detailed from time to time in the reports filed by Scios
with the SEC, including the Company's annual report on form 10-K for the year
ended December 31, 2000 and quarterly report filed on form 10-Q for the
quarter ended March 31, 2001.
SCIOS INC.
Consolidated Balance Sheets
(In thousands, except share data)
ASSETS June 30, December 31,
2001 2000
(Unaudited)
Current assets:
Cash and cash equivalents $20,726 $3,291
Marketable securities 65,667 35,356
Accounts receivable 5,083 5,217
Prepaid expenses 1,241 722
Total current assets 92,717 44,586
Marketable securities, non-current 77,839 32,884
Property and equipment, net 8,171 8,910
Other assets 3,890 2,007
TOTAL ASSETS $182,617 $88,387
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $8,500 $4,587
Other accrued liabilities 7,726 10,749
Deferred contract revenue 14,098 16,193
Total current liabilities 30,324 31,529
Long-term debt 40,697 39,095
Total liabilities 71,021 70,624
Stockholders' equity:
Series A preferred stock; $.001
par value; 20,000,000 shares
authorized; issued and outstanding
4,991 shares and none respectively -- --
Series B preferred stock; $.001
par value; 5,000,000 shares
authorized; none issued and
outstanding -- --
Common stock; $.001 par value;
150,000,000 shares authorized;
issued and outstanding
45,365,590 and 39,166,373,
respectively 45 39
Additional paid-in capital 545,450 428,987
Notes receivable from stockholders (446) (634)
Deferred compensation, net (106) (417)
Accumulated other comprehensive
income 556 1,195
Accumulated deficit (433,903) (411,407)
Total stockholders' equity 111,596 17,763
TOTAL LIABILITIES AND STOCKHOLDERS'
EQUITY $182,617 $88,387
SCIOS INC.
Consolidated Statements of Operations
(In thousands, except share and per share data)
Three months ended Six months ended
June 30, June 30,
2001 2000 2001 2000
(Unaudited) (Unaudited)
Revenues:
Product sales $2,098 $-- $2,098 $--
Research &
development
contracts 1,484 1,482 2,581 3,376
Gain on sale of
marketing
rights -- -- 9,363 --
Psychiatric
product sales,
co-promotion
commissions,
net of expenses 1,659 1,584 3,142 2,915
5,241 3,066 17,184 6,291
Costs and
expenses:
Research and
development 13,084 11,294 22,564 20,578
Marketing,
general and
administration 10,278 2,756 16,758 6,232
Restructuring
charges
(credits) -- (993) -- (993)
23,362 13,057 39,322 25,817
Loss from
operations (18,121) (9,991) (22,138) (19,526)
Other income and
expense:
Investment
income 742 1,204 1,554 2,588
Interest
expense (754) (1,019) (1,603) (2,010)
Realized gains
(losses) on
securities 135 (100) 389 (184)
Other income
(expense), net (275) (403) (698) (702)
(151) (318) (358) (308)
Net loss $(18,273) $(10,309) $(22,496) $(19,834)
Loss per common
share:
Basic and
diluted $(0.46) $(0.27) $(0.57) $(0.52)
Weighted average
number of common
shares outstanding
used in calculation
of:
Basic and diluted 40,087,161 37,780,077 39,653,959 37,780,077
SOURCE Scios, Inc.
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Related links:
http://www.sciosinc.com
CONTACT:
Wendy Carhart of Scios Inc., +1-408-616-8325;
or media, Jim Weiss of Weisscomm, +1-415-203-0328, for Scios
Inc.; or investors, Ed Bisno of Edelman PR Worldwide,
+1-212-704-8212, for Scios Inc.
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