PROACTION Pilot Study Supports the Use of Natrecor in the Emergency Department
SUNNYVALE, Calif., July 25 /PRNewswire-FirstCall/ --
Scios Inc. (Nasdaq: SCIO) announced today its financial results for the second
quarter and six months ended June 30, 2002.
Scios reported that net sales for its lead product Natrecor(R)
(nesiritide) for the second quarter and first six months of 2002 were
$22.5 million and $37.9 million, respectively. The company also announced
that it is raising its full-year 2002 net sales forecast for Natrecor from
$75 to $80 million to $90 to $95 million and expects net sales in the third
quarter of 2002 to be $23 to $25 million. Peak U.S. sales for the drug are
expected to be in the range of $500 to $600 million versus previous estimates
of $200 to $300 million.
The ADHERE Registry has enrolled over 12,000 heart failure patients
to date, continuing to exceed the company's original goal of enrolling
10,000 patients by the end of this year.
"Natrecor may rank as one of the most successful intravenous
cardiovascular products launched in the U.S. in terms of first-year sales,"
said Richard B. Brewer, Scios' president and chief executive officer. "We
have increased our sales forecast since Natrecor is being used not only for
patients with a primary diagnosis of acute heart failure, but also in patients
who are treated for acute heart failure as a secondary diagnosis. In
addition, because of its favorable safety profile, ease of use and high rates
of physician satisfaction, Natrecor is being used by a wide range of
physicians to treat acute heart failure in patients with a variety of
underlying conditions."
Results of PROACTION Pilot Study
Scios announced results of the PROACTION (Prospective Randomized Outcomes
Study of Acutely Decompensated Congestive Heart Failure Treated Initially in
Outpatients with Natrecor) trial. As a pilot study, two hundred and thirty
seven patients were enrolled and treated in the ED/Observation Unit (ED/OU) at
38 U.S. hospitals. The study was designed to compare the clinical effects,
safety profile and economic impact of Natrecor plus standard therapy to
placebo plus standard therapy, when administered in the ED/OU. Outcomes were
assessed over thirty days.
The study confirmed that Natrecor could be used safely in the ED/OU.
Results suggest that early use of Natrecor in the ED/OU may decrease the rate
of initial hospital admissions and re-admissions following initial hospital
discharge, versus standard care. These improved clinical outcomes may lead to
cost reductions that neutralize the cost of Natrecor when compared to standard
care alone.
"The PROACTION trial shows that Natrecor is safe and effective in the
hands of emergency medicine physicians as well as physicians in the
observation unit," said Charles L. Emerman, M.D., Chairman, Department of
Emergency Medicine, Cleveland Clinic Foundation.
"These results suggest that Natrecor can improve early treatment of acute
heart failure in the emergency department at no additional cost. Because
hospitals typically lose money on Medicare patients who are hospitalized for
heart failure, use of Natrecor in the emergency department has the potential
to improve hospital financial performance," said J. Sanford Schwartz, M.D.,
Professor of Medicine, Health Management and Economics, School of Medicine and
the Wharton School of Business, University of Pennsylvania.
Pipeline Update
In addition to increasing sales of Natrecor in the acute heart failure
market, Scios is evaluating additional opportunities for the product. Scios
continues to enroll patients in a pilot study called FUSION (Follow Up Serial
Infusions Of Natrecor), which is designed to evaluate the safety and
tolerability of Natrecor when administered in an outpatient setting to
patients with chronic congestive heart failure who are at high risk for
hospitalization. As of July 23, 2002, 135 of the targeted 210 patients have
been enrolled in the study.
Scios also provided an update on enrollment in its Phase IIa clinical
trial evaluating SCIO-469, its novel oral p38 kinase inhibitor for the
treatment of rheumatoid arthritis (RA). As of July 23, 2002, this
multi-center, randomized, placebo-controlled clinical study has enrolled
42 out of 120 patients who have active RA and are receiving methotrexate. The
main objective of the study is to evaluate the safety and tolerability of six
escalating doses of SCIO-469 in RA patients. The company expects to announce
results from this study in the first quarter of 2003. The company also
announced the identification of SCIO-323, a more potent second-generation
p38 kinase inhibitor that is advancing through preclinical development.
Scios is also pursuing development of oral inhibitors of TGF-beta for a
broad range of clinical indications, and announced today that its lead
indication for these compounds will be chronic obstructive pulmonary disease
(COPD).
TGF-beta is a multifunctional cytokine that regulates cell proliferation
and differentiation in a variety of diseases. Research indicates that an
excess of TGF-beta is implicated in inflammation and scar tissue formation in
both the cardiovascular system and a variety of conditions including COPD,
congestive heart failure (CHF), liver cirrhosis, and diabetic nephropathy.
"TGF-beta is implicated in a wide range of chronic and acute diseases, and
our lead compounds have shown efficacy in several preclinical disease models,"
commented George Schreiner, M.D., Ph.D. and Chief Scientific Officer of Scios.
"The initial success of our drug development program targeting this important
pathway validates the effective platform technology created by Scios that
focuses on kinases as therapeutic targets."
Second Quarter and First Six Months 2002 Financial Results and
Full-year 2002 Outlook
Second quarter 2002 net revenues were $23.0 million compared to
$5.2 million in the second quarter of 2001. This increase was primarily due
to Natrecor sales.
Total costs and expenses for the second quarter of 2002 were $44.3 million
compared to $23.4 million in the second quarter of 2001. The increase in
costs and expenses was largely attributable to building a marketing and sales
infrastructure for Natrecor, clinical development of the p38 kinase inhibitor
program and preclinical development of the TGF-beta program. Selling, general
and administrative expenses are expected to be $105 to $110 million for the
full-year 2002. Research and development expenses are expected to be $75 to
$80 million for the full-year 2002.
Net loss for the quarter was $22.5 million, or $0.48 per diluted share,
compared to a net loss of $18.3 million, or $0.46 per diluted share, for the
same period last year. Per share amounts were based on 46.5 million weighted
average diluted shares in the second quarter of 2002, compared to 40.1 million
weighted average diluted shares in the same quarter last year. Due to
expected increases in total costs and expenses related to increases in
research and development and selling, general and administrative expenses, net
loss is expected to be $70 to $75 million. The company expects to be
profitable in 2004.
Cash, cash equivalents and marketable securities (both current and
non-current) balances at June 30, 2002 were $101.3 million.
Net revenues for the first six months of 2002 were $39.5 million compared
to $17.2 million in the same period last year. The increase was primarily due
to Natrecor sales of $37.9 million. Total costs and expenses in the six-month
period were $84.8 million, compared to $39.3 million for the year-ago period.
The six months period ended June 30, 2001 included $12.5 million of revenues,
inclusive of a $9.4 million gain on the sale of marketing rights from the
Psychiatric Sales and Marketing Division that was discontinued in March 2001.
The company reported a net loss of $47.7 million in the first six months of
2002, or $1.03 per diluted share, compared to a $22.5 million net loss, or
$0.57 per diluted share, in the same period last year.
Second Quarter/Investor Day Conference Call Details
The Scios second-quarter results/Investor Day conference call will begin
today at 10:00 a.m. EDT and can be accessed via webcast on the company's
website at http://www.sciosinc.com. To access the conference call, participants
calling from the U.S. or Canada should dial 800-399-7909. International
callers can dial 706-634-5159. All conference call participants should
request Conference I.D. 4381069.
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 "estimate," "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 and inhibitors to TGF-beta, our ability to partner the development
and commercialization of our pipeline products and Natrecor (outside the U.S.
and Europe) with third parties on favorable terms, or at all, 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 Balance Sheets
(in thousands, except share data and per share data)
June 30, December 31,
2002 2001
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $39,212 $58,296
Marketable securities 13,396 7,351
Accounts receivable, net 11,081 6,943
Inventory 2,613 1,158
Prepaid expenses and other assets 5,070 4,214
Total current assets 71,372 77,962
Marketable securities, non-current 48,673 63,669
Property and equipment, net 10,252 10,424
Other assets 758 4,123
Total assets $131,055 $156,178
Liabilities and stockholder's equity
Current liabilities:
Accounts payable $7,727 $9,625
Accrued employee compensation 10,697 9,685
Other accrued liabilities 9,531 7,206
Deferred contract revenue 1,102 --
Current portion of long-term debt 41,313 33,035
Total current liabilities 70,370 59,551
Deferred contract revenue 3,493 --
Long-term debt 15,396 15,479
Total liabilities 89,259 75,030
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 46,654,473
and 46,015,167, respectively 47 46
Additional paid-in capital 567,958 561,352
Treasury stock; shares of 40,000
at June 30, 2002 and 30,000 at
December 31, 2001, respectively (644) (445)
Deferred warrant costs (4,389) (6,794)
Deferred compensation (106) (106)
Accumulated other comprehensive income 564 999
Accumulated deficit (521,634) (473,904)
Total stockholders' equity 41,796 81,148
Total liabilities and stockholders'
equity $131,055 $156,178
SCIOS INC.
Consolidated Statements of Operations
(in thousands, except share and per share data)
Three months ended Six months ended
June 30, June 30,
2002 2001 2002 2001
(Unaudited) (Unaudited)
Revenues:
Product sales $22,510 $2,098 $37,883 $2,098
Research and development
contracts and royalties 517 1,484 1,588 2,581
Psychiatric product sales
and co-promotion
commissions, net of expenses -- 1,659 -- 3,142
Gain on sale of marketing
rights -- -- -- 9,363
23,027 5,241 39,471 17,184
Costs and expenses:
Cost of product sales 1,381 -- 2,392 --
Research and development 16,808 13,084 31,663 22,564
Selling, general and
administration 26,075 10,278 50,789 16,758
44,264 23,362 84,844 39,322
Loss from operations (21,237) (18,121) (45,373) (22,138)
Other income (expense):
Interest income 913 742 1,721 1,554
Interest expense (2,498) (754) (4,442) (1,603)
Realized gains on securities 370 135 293 389
Other income (expense) (56) (275) 71 (698)
(1,271) (152) (2,357) (358)
Net loss $(22,508) $(18,273) $(47,730) $(22,496)
Loss per common share:
Basic and diluted $(0.48) $(0.46) $(1.03) $(0.57)
Weighted average number of
common shares outstanding
used in calculation of:
Basic and diluted 46,478,885 40,087,161 46,290,276 39,653,959
SOURCE Scios Inc.
 back to top
Related links:
http://www.sciosinc.com
CONTACT:
Suzanne Beveridge of Scios Inc.,
+1-408-616-2947, or +1-408-616-8328; or press only, Jim Weiss of
WeissCom Partners, Inc., +1-415-260-1274; or investors only, Fern
Lazar or Sara Moorin of Lazar Partners Ltd., +1-212-867-1762,
both for Scios Inc.
|
