>>SUNNYVALE, Calif., Oct. 24 /PRNewswire-FirstCall/ -- Scios Inc. (Nasdaq: SCIO - News) today announced financial results for the three-month and nine-month periods ended September 30, 2002.
The company reported net revenues of $27.2 million in the third quarter of 2002 compared to $19.6 million in the same period last year. Net sales of the company's flagship product, Natrecor® (nesiritide), were $26.1 million, a 16 percent increase over the prior quarter, largely driven by demand in the hospital setting. Natrecor sales were $4.5 million during the same period last year.
"The strong sales performance for Natrecor in the third quarter puts us on track to achieve our year-end sales forecast of $92 to $95 million," said Richard B. Brewer, president and chief executive officer of Scios. "As we continue to penetrate the inpatient market segment and use in the emergency department and hospital observation units continues to grow, we forecast Natrecor net sales to grow to the range of $160 to $170 million in 2003."
The company also announced that GlaxoSmithkline has submitted a Marketing Authorization Application with the European Agency for the Evaluation of Medicinal Products for nesiritide for the treatment of patients with acutely decompensated heart failure.
Product and Pipeline Highlights
Natrecor
-- Approximately 85 percent of the targeted hospitals have now stocked
Natrecor.
-- Effective January 1, 2003, the Center for Medicare and Medicaid
Services has granted a permanent J code for the reimbursement of
Natrecor use in the physician office setting. Natrecor also is
reimbursed in the hospital outpatient setting through a specific
ambulatory payment code (APC), effective from April 1, 2002.
-- Enrollment was completed in the 210-patient FUSION (Follow Up Serial
Infusions of Nesiritide) pilot study, which is evaluating the safety
and feasibility of follow-up serial infusions of Natrecor.
-- The ADHERE (Acute Decompensated Heart Failure National Registry)
Registry has enrolled over 20,000 patients, more than twice the initial
target for this year.
-- Enrollment began in a longitudinal study module of the ADHERE Registry
that will follow patients with advanced heart failure for up to two
years to assess change in quality of life as a function of medical
management and disease progression.
-- More than 20 abstracts related to Natrecor or the ADHERE Registry were
presented at several professional medical meetings, including the Heart
Failure Society of America, the Transcatheter Therapeutics conference
and the American College of Emergency Physicians.
SCIO-469 and p38 MAP Kinase Inhibitor Programs
-- Patients enrolled in the first treatment group of the Phase IIa
clinical trial evaluating SCIO-469, the company's first-generation oral
p38 MAP kinase inhibitor, completed treatment and follow up. Following
the independent safety review of the first treatment group, enrollment
in the second treatment group is underway to evaluate the next two
doses in the trial.
-- Dr. Ernest Brahn from the UCLA School of Medicine will present
preclinical data at the American College of Rheumatology annual meeting
in New Orleans on October 28, 2002, indicating improvement in clinical
severity and radiographic progression in collagen-induced arthritis for
both SCIO-469 and SCIO-323, a second-generation p38 MAP kinase
inhibitor.
Third Quarter and First Nine-Month Financial Results
Total costs and expenses for the third quarter of 2002 were $45.2 million compared to $32.5 million for the same quarter last year.
Research and development (R&D) expenses for the third quarter were $19.3 million, an increase of 15 percent over the second quarter of 2002, primarily driven by expenses related to the preclinical and clinical development studies for the p38 MAP kinase inhibitor program.
Selling, general and administrative (SG&A) expenses were $24.5 million in the third quarter of 2002, six percent lower than the prior quarter. The decrease was primarily related to the timing of expenses related to Natrecor promotional activities.
Net loss for the third quarter of 2002 was $21.8 million, or $0.47 per share, compared to a net loss of $11.2 million, or $0.25 per share, for the same period last year.
Total costs and expenses in the nine-month period ended September 30, 2002 were $130.1 million compared to $71.8 million for the same period a year ago. The company reported a net loss of $69.6 million, or $1.50 per share, for the nine months ended September 30, 2002, compared to a net loss of $33.7 million, or $0.81 per share, for the comparable period in 2001.
Cash, cash equivalents and marketable securities (both current and non-current) at September 30, 2002 were $173.1 million, excluding $24.1 million of restricted marketable securities.
Financial Forecasts for 2002
-- Natrecor net sales for 2002 are expected to be in the range of $92 to
$95 million;
-- Combined R&D and SG&A expenses for 2002 are expected to be in the range
of $180 to 190 million;
-- Net loss for 2002 is expected to be in the range of $70 to $75 million
if a partnering transaction is completed before the end of 2002. If no
such partnering transaction is completed this year, net loss is
expected to be in the range of $95 to $100 million.
Today's Conference Call Details
Scios will host its quarterly conference call today, October 24, 2002, at 7:00 a.m. PT / 10:00 a.m. ET to discuss the results of the quarter. The call will be broadcast live and archived on Scios' web site at sciosinc.com until October 31, 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 preclinical and clinical trials of our pipeline products, including SCIO-469, SCIO-323, and inhibitors of TGF beta 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)
September 30, December 31,
2002 2001
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $35,017 $58,296
Marketable securities 23,064 7,351
Restricted marketable securities 8,403 --
Accounts receivable, net 11,813 6,943
Inventory 3,472 1,158
Prepaid expenses and other assets 6,306 4,214
Total current assets 88,075 77,962
Marketable securities, non-current 114,993 63,669
Restricted marketable securities 15,700 --
Property and equipment, net 10,292 10,424
Other assets 8,354 4,123
Total assets $237,414 $156,178
Liabilities and stockholder's equity
Current liabilities:
Accounts payable $11,857 $9,625
Accrued employee compensation 11,759 9,685
Other accrued liabilities 12,464 7,206
Deferred contract revenue 1,289 --
Accrued interest payable 1,260 3,035
Current portion of long-term debt 17,537 30,000
Total current liabilities 56,166 59,551
Deferred contract revenue 3,237 --
Long-term debt 160,738 15,479
Total liabilities 220,141 75,030
Stockholders' equity:
Preferred stock; $.001 par value; 20,000,000
shares authorized; 4,991 shares issued and
outstanding -- --
Common stock; $.001 par value; 150,000,000
shares authorized; 46,722,127 and 46,015,167
shares issued, respectively; 46,460,327 and
45,985,167 shares outstanding, respectively 47 46
Additional paid-in capital 569,157 561,352
Treasury stock; shares of 261,800 at
September 30, 2002 and 30,000 at
December 31, 2001, respectively (6,014) (445)
Deferred warrant costs (3,291) (6,794)
Deferred compensation -- (106)
Accumulated other comprehensive income 837 999
Accumulated deficit (543,463) (473,904)
Total stockholders' equity 17,273 81,148
Total liabilities and
stockholders' equity $237,414 $156,178
SCIOS INC.
Consolidated Statements of Operations
(in thousands, except share and per share data)
Three months ended Nine months ended
September 30, September 30,
2002 2001 2002 2001
(Unaudited) (Unaudited)
Revenues:
Product sales $26,140 $18,330 $64,023 $20,428
Research and development
contracts and royalties 1,017 1,284 2,605 3,865
Psychiatric product sales
and co-promotion commissions,
net of expenses -- -- -- 3,142
Gain on sale of marketing rights -- -- -- 9,363
27,157 19,614 66,628 36,798
Costs and expenses:
Cost of product sales 1,410 2,035 3,802 2,035
Research and development 19,292 12,101 50,955 34,665
Selling, general and
administration 24,511 18,347 75,300 35,105
45,213 32,483 130,057 71,805
Loss from operations (18,056) (12,869) (63,429) (35,007)
Other income (expense):
Interest income 1,103 1,929 2,824 3,483
Interest expense (4,912) (653) (9,354) (2,256)
Realized gains on securities,
net 169 205 462 594
Other income (expense), net (133) 221 (62) (477)
(3,773) 1,702 (6,130) 1,344
Net loss $(21,829) $(11,167) $(69,559) $(33,663)
Net loss per common share:
Basic and diluted $(0.47) $(0.25) $(1.50) $(0.81)
Weighted average number of
common shares outstanding used
in calculation of:
Basic and diluted 46,556,765 45,383,394 46,353,683 41,563,771<<
Cheers, Tuck |
