SUNNYVALE, Calif., April 26 /PRNewswire/ -- Scios Inc. (Nasdaq: SCIO)
today announced financial results for the first quarter ended March 31, 2001.
The Company also updated investors on the status of its lead products in
development, Natrecor(R) (nesiritide) for the treatment of acute Congestive
Heart Failure (aCHF) and SCIO-469, its p38 MAP kinase inhibitor for the
treatment of Rheumatoid Arthritis (RA).
"Scios gained momentum on all fronts during the first quarter as we
continue to work with the U.S. Food and Drug Administration (FDA) to obtain
approval to market Natrecor, our flagship product, and continue our
preparations to launch Natrecor later this year," said Richard B. Brewer,
Scios' president and chief executive officer. "Together with Innovex,
Quintiles Transnational Corp.'s commercialization unit, we are building a
strong sales and marketing force that will be the largest and the most focused
in the aCHF market. To that end, we have hired two area business directors
who will coordinate and lead the sales effort in the field, and we have hired
15 (of 18 total) business managers to support the 180-person sales force.
Also, during the quarter, Natrecor data was presented at the American College
of Cardiology meeting. We are now preparing for and look forward to the FDA's
Cardiovascular and Renal Drugs Advisory Committee meeting May 25th to review
the amended NDA we submitted earlier this year."
Mr. Brewer added, "We are also investing in Scios' future by moving
SCIO-469 into clinical trials as efficiently as possible, selecting a new
compound from our research pipeline for clinical development, and
strengthening our core drug discovery capabilities."
First Quarter Financial Results
Net revenues for the quarter ended March 31, 2001 were $11.9 million
compared to $3.2 million in the first quarter of 2000. In connection with
returning the license to market five psychiatric products to Glaxo SmithKline,
Scios recognized a one-time $9.4 million fee in the first quarter. This
transaction further streamlined the Company's operations, ending Scios'
involvement with psychiatric sales and marketing activities.
Total costs and expenses for the first quarter of 2001 were $16.0 million
versus $12.8 million for the quarter ended March 31, 2000. The increase in
costs and expenses for the quarter is largely attributable to the costs
associated with building a marketing and sales infrastructure for Natrecor.
The Company reported a net loss of $4.2 million or $0.11 per diluted share
for the quarter ended March 31, 2001, compared to a net loss of $9.5 million,
or $0.25 per diluted share, for the comparative quarter in 2000.
Cash and marketable securities (both current and non-current) balances at
March 31, 2001 totaled $62.2 million.
Natrecor Update
During the quarter, Scios initiated the PROACTION (Prospective Randomized
Outcomes Study of Acutely Decompensated Congestive Heart Failure Treated
Initially in Outpatients with Natrecor) trial, a pilot study designed to
compare the clinical effects, safety profile and economic impact of standard
therapy plus Natrecor to standard therapy plus placebo. The PROACTION trial
has enrolled twenty-four of the target number of 250 acute CHF patients so
far, and Scios expects to complete this study in the third quarter of 2001.
These patients are being treated in the Emergency Department or Observation
Unit, where the majority of the one million hospitalizations each year for
this indication begin.
SCIO-469 Progress
Scios recently completed a Phase Ia trial of SCIO-469 in which single oral
doses were shown to be safe and well-tolerated.
A double-blind, placebo-controlled, multiple oral dose Phase Ib study to
further determine the safety and tolerability of multiple oral doses of
SCIO-469 has also been completed, and results will be reported next week by
Dr. George Schreiner, Scios' chief scientific officer, at the "Advances in
Anti-Arthritic Agents" conference in London. A Phase II trial in RA patients
is expected to begin during the second half of 2001.
Kaken Approval
Kaken Pharmaceuticals Co., Ltd. has received notice from the Japanese
Ministry of Health and Welfare that they have been granted marketing approval
for Fiblast Spray as a treatment for dermal ulcers. The active ingredient in
Fiblast Spray is recombinant basic Fibroblast Growth Factor (FGF), which Kaken
licensed from Scios in 1988. Based on this approval, Scios expects to
recognize $15.9 million in revenue during 2001 as FGF is shipped to Kaken in
Japan. The $15.9 million was previously recognized as deferred revenue on
Scios' Balance Sheet.
Today's Conference Call Details
As previously announced, Scios will host a conference call today at
7:00 a.m. PT / 10:00 a.m. ET to discuss the results of the first quarter of
2001. The dial-in number is 800-314-7867. The call will also be broadcast
live and archived on Scios' web site at http://www.sciosinc.com until
May 3, 2001. A telephone replay of this conference call will be available
until May 3, 2001 at 4 p.m. PT by calling 888-203-1112. The confirmation code
is 798190.
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).
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 regulatory approval of Natrecor, the
sales penetration and success of Natrecor, the successful completion of
additional studies with Natrecor and SCIO-469, the results of competing
companies attempting to develop or improve other treatments for rheumatoid
arthritis and acute heart failure, 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.
SCIOS INC.
AND SUBSIDIARY
Consolidated Balance Sheets
(In thousands, except share data)
March 31, December 31,
2001 2000
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $613 $3,291
Marketable securities 28,002 35,356
Accounts receivable 12,204 5,217
Prepaid expenses 1,043 902
Total current assets 41,862 44,766
Marketable securities, non-current 33,564 32,884
Property and equipment, net 8,119 8,910
Other assets 2,542 2,007
TOTAL ASSETS $86,087 $88,567
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $3,919 $4,587
Other accrued liabilities 10,236 10,749
Deferred contract revenue 16,372 16,193
Total current liabilities 30,527 31,529
Long-term debt 39,944 39,095
Total liabilities 70,471 70,624
Stockholders' equity:
Preferred stock; $.001 par value; 20,000,000
shares authorized; 4,991 issued and outstanding
Common stock; $.001 par value;
150,000,000 shares authorized;
issued and outstanding
39,364,224 and
39,166,373 shares, respectively 39 39
Additional paid-in capital 430,408 428,987
Notes receivable from stockholders (406) (454)
Deferred compensation, net (106) (417)
Accumulated other comprehensive income 1,311 1,195
Accumulated deficit (415,630) (411,407)
Total stockholders' equity 15,616 17,943
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $86,087 $88,567
SCIOS INC.
AND SUBSIDIARY
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
Three months ended
March 31,
2001 2000
(Unaudited)
Revenues:
Product sales, co-promotion
commissions & other related
revenue, net of expenses $10,846 $ 1,331
Research and development contracts 1,097 1,894
11,943 3,225
Costs and expenses:
Research and development 9,480 9,284
Marketing, general and administration 6,480 3,476
15,960 12,760
Loss from operations (4,017) (9,535)
Other income and expenses:
Investment income 812 1,384
Interest expense (849) (991)
Realized gains (losses) on securities 254 (84)
Other expense, net (423) (299)
(206) 10
Net Loss $(4,223) $(9,525)
Loss per common share:
Basic and Diluted $ (0.11) $ (0.25)
Weighted average number of
common shares outstanding
used in calculation of:
Basic and Diluted 39,290,982 37,780,077
SOURCE Scios Inc.
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Related links:
http://www.sciosinc.com
CONTACT:
Wendy Carhart of Scios Inc., 408-616 8325; or
press, Jim Weiss of Weisscomm, 415-203 0328, for Scios, Inc.
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