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Proc-Type: 2001,MIC-CLEAR
Originator-Name: webmaster@www.sec.gov
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0001102624-06-000055.txt : 20060301
0001102624-06-000055.hdr.sgml : 20060301
20060301092841
ACCESSION NUMBER: 0001102624-06-000055
CONFORMED SUBMISSION TYPE: 8-K
PUBLIC DOCUMENT COUNT: 2
CONFORMED PERIOD OF REPORT: 20060301
ITEM INFORMATION: Results of Operations and Financial Condition
ITEM INFORMATION: Financial Statements and Exhibits
FILED AS OF DATE: 20060301
DATE AS OF CHANGE: 20060301
FILER:
COMPANY DATA:
COMPANY CONFORMED NAME: SCICLONE PHARMACEUTICALS INC
CENTRAL INDEX KEY: 0000880771
STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834]
IRS NUMBER: 943116852
STATE OF INCORPORATION: DE
FISCAL YEAR END: 1231
FILING VALUES:
FORM TYPE: 8-K
SEC ACT: 1934 Act
SEC FILE NUMBER: 000-19825
FILM NUMBER: 06653289
BUSINESS ADDRESS:
STREET 1: 901 MARINER'S ISLAND BLVD.
STREET 2: SUITE 205
CITY: SAN MATEO
STATE: CA
ZIP: 94404
BUSINESS PHONE: 650-358-3456
MAIL ADDRESS:
STREET 1: 901 MARINER'S ISLAND BLVD.
STREET 2: SUITE 205
CITY: SAN MATEO
STATE: CA
ZIP: 94404
8-K
1
sciclone8k.htm
SCICLONE PHARMACEUTICALS 8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
|
Date of Report: March 01, 2006
(Date of earliest event reported)
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SciClone Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction of incorporation)
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0-19825
(Commission File Number)
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94-3116852
(IRS Employer Identification Number)
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901 Mariner's Island Blvd., Suite 205, San Mateo, CA
(Address of principal executive offices)
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94404
(Zip Code)
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650-358-3456 (Registrant's telephone number, including area code)
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Not Applicable (Former Name or Former Address, if changed since last report)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
- o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
- o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
- o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
- o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition
On March 1, 2006, SciClone Pharmaceuticals, Inc. (the "Company") issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2005. A copy of the Company's press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits
(a) Financial statements:
None
(b) Pro forma financial information:
None
(c) Shell company transactions:
None
(d) Exhibits
99.1 Press Release of SciClone Pharmaceuticals, Inc. dated March 01, 2006
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be
signed on its behalf by the undersigned hereunto duly authorized.
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Dated: March 01, 2006
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SCICLONE PHARMACEUTICALS, INC.
By: /s/ Richard A. Waldron
Richard A. Waldron
Chief Financial Officer
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Exhibit Index
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Exhibit No. |
Description |
99.1 |
Press Release of SciClone Pharmaceuticals, Inc. dated March 01, 2006 |
EX-99
2
sciclonepharmaceuti.htm
SCICLONE PHARMACEUTICALS PRESS RELEASE
SciClone Reports Results for Fourth Quarter and Year-End 2005
SAN MATEO, CA -- 03/01/2006 -- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN)
today reported results for the fourth quarter and full year ended December
31, 2005. For the fourth quarter 2005, revenues from the sale of
ZADAXIN®, SciClone's lead product, increased by 22% to $7,314,000,
compared with revenues of $5,985,000 reported for the fourth quarter 2004.
For the full year ended December 31, 2005, product revenues increased by
22% to $27,842,000, compared with product revenues of $22,765,000 for 2004.
The increase in product revenues for the fourth quarter and year ended
December 31, 2005 is primarily attributable to an increase in the quantity
of ZADAXIN sold to the China market, which accounts for approximately 91%
of overall ZADAXIN sales.
Net loss for the fourth quarter 2005 totaled $1,625,000, or $0.04 per
share, a decrease of 30% from the net loss of $2,355,000, or $0.05 per
share, for the fourth quarter 2004. For the full year ended December 31,
2005, net loss was $7,713,000, or $0.17 per share, a 42% decrease from the
net loss of $13,278,000, or $0.30 per share, for the full year ended
December 31, 2004.
"We are pleased with the increasing trend in sales of ZADAXIN to China, a
market where ZADAXIN is approved for hepatitis B and is used extensively in
the oncology and intensive care settings," said Ira D. Lawrence, M.D.,
President and Chief Executive Officer of SciClone Pharmaceuticals, Inc.
"As we continue in 2006, we intend to build on our strong reputation in
China by devoting additional resources to expand our product offerings and
our development and regulatory capabilities in that market. At the same
time, we continue to advance our clinical pipeline. We expect additional
ZADAXIN melanoma results later this year and we expect to meet with
regulatory authorities to finalize plans for phase 3 trials. In addition,
we plan to initiate a phase 1 study evaluating oral formulations of SCV-07
in the second quarter of this year and to begin phase 2a studies for SCV-07
starting in the second half of this year."
Contract revenue for the fourth quarter 2005 was $90,000 compared with
$134,000 for the fourth quarter 2004. For the full year ended December 31,
2005, contract revenue totaled $492,000, compared with $1,631,000 for the
full year ended December 31, 2004. Contract revenue for the full year
ended December 31, 2004 included a $1,000,000 milestone payment from
Sigma-Tau, SciClone's European marketing and development partner for
ZADAXIN.
Research and development expenses for the fourth quarter 2005 totaled
$3,213,000, a 28% decrease from $4,442,000 for the fourth quarter 2004.
Research and development expenses for the full year ended December 31, 2005
were $14,406,000, a 20% decrease from $17,994,000 for the full year ended
December 31, 2004. These decreases are mainly attributable to the
reduction in expenses associated with SciClone's U.S. phase 3 hepatitis C
trials.
General and administrative (G&A) expenses for the fourth quarter 2005 were
$1,944,000, a 51% increase from $1,289,000 for the fourth quarter 2004. G&A
expenses for the full year 2005 were $7,457,000, an 18% increase from
$6,311,000 for the full year 2004. The increase in the fourth quarter 2005
was due to higher salary expenses, increased legal costs and accounting
fees, and a reversal of a bad debt expense of $186,000 that lowered G&A
expenses in the fourth quarter of 2004. The increase in G&A expenses for
2005 are primarily attributed to increased legal costs, and accounting
fees, and the expensing of stock price-based options.
Cash, cash equivalents and short-term investments totaled $42,256,000 at
December 31, 2005, compared with $49,524,000 at September 30, 2005 and
$51,299,000 at December 31, 2004. Part of the decrease in cash, cash
equivalents and short-term investments is attributable to the repayment of
a $4 million convertible note in December 2005.
Financial Guidance for Full Year 2006
Based on SciClone's current plans for operations and clinical development,
the Company estimates that revenues from the sale of ZADAXIN for the full
year 2006 will increase to approximately $32,000,000 driven primarily by
continued growth in sales to China. Research and development expenses for
the full year 2006 are estimated to be approximately $14,000,000 as new
programs are advanced as described above and below. Net loss for the full
year 2006 is estimated to be approximately $6,100,000, or $0.13 net loss
per share.
In January 2006, the Company adopted Financial Accounting Standards Board
Statement No.123 (revised 2004), "Share-Based Payment" (SFAS 123R)
requiring share-based payments to employees and directors, including grants
of stock options, to be recognized in statement of operations based on
their fair values. Including SFAS 123R related charges, the Company
estimates research and development expenses for the full year 2006 to be
appoximately $14,800,000, and net loss for the full year 2006 to be
approximately $8,900,000, or $0.19 net loss per share. SFAS 123R related
expenses will be non-cash charges.
Cash, cash equivalents and short-term investments at year-end 2006 are
estimated to be approximately $29,000,000 including the repayment of
$1,600,000 of convertible notes in March 2006.
Recent Clinical Development Highlights
SciClone recently completed phase 1 single and multi-dose escalation
studies and achieved positive results demonstrating that SCV-07, its second
drug candidate, appears to be safe and well tolerated in healthy
volunteers. SCV-07 was administered subcutaneously in varying dose levels
up to a dose of 1 mg/kg, approximately one thousand times the dose level
utilized in a proof-of-concept tuberculosis trial in Russia, without any
dose-limiting adverse effects.
Based on promising data from pre-clinical studies that demonstrated the
oral bioavailability of SCV-07 in an animal model, SciClone plans to
initiate a phase 1 clinical trial evaluating two oral formulations of
SCV-07 in healthy volunteers in the second quarter of 2006. If this study
yields favorable results, SciClone believes that the availability of an oral
formulation of SCV-07 would considerably broaden the development
opportunities for
SCV-07. Additionally, based on pre-clinical data that suggest SCV-07's
utility in a variety of clinical settings including viral and infectious
diseases, SciClone intends to initiate phase 2a studies with the
subcutaneous formulation of SCV-07 starting in the second half of this
year.
Update on Mediation with Schering Plough KK (SPKK)
As part of the mediation process, SciClone and SPKK have exchanged and are
exchanging certain information and are discussing issues for resolution.
The mediation is expected to conclude by the end of March 2006. Should
SciClone and SPKK be unable to come to a mutually satisfactory and fair
resolution by the end of the mediation, it is expected that binding
arbitration would commence soon thereafter.
Conference Call
SciClone will host a conference call at 11:30 a.m. ET (8:30 a.m. PT) today,
Wednesday, March 1, 2006. The call will contain forward-looking
statements. Financial and statistical information to be discussed in the
conference call will be posted on the investor relations section of
SciClone's web site at www.sciclone.com prior to the commencement of the
conference call.
DATE: Wednesday, March 1, 2006
TIME: 11:30 a.m. ET (8:30 a.m. PT)
WEBCAST: Live call and replay accessible at www.sciclone.com
LIVE CALL: 877-502-9276 (U.S./Canada)
913-981-5591 (international)
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the
development of therapeutics to treat
life-threatening diseases. SciClone's lead product ZADAXIN® is currently
being evaluated in late-stage clinical trials for the treatment of
malignant melanoma and hepatitis C. ZADAXIN is approved for sale in select
markets internationally, most notably in China where SciClone has an
established sales and marketing operation. SciClone's strategy is to
leverage its advantage in China by in-licensing or acquiring the marketing
rights to other products to market in this rapidly growing pharmaceutical
market. SciClone's other drug development candidate is SCV-07, currently
in early clinical development in the U.S. for the treatment of viral and
other infectious diseases. For more information about SciClone, visit
www.sciclone.com.
The information in this press release contains forward-looking statements
including our expectations and beliefs regarding future sales and financial
results for 2006, and progress and results of our clinical trials. Words
such as "expects," "plans," "believe," "may," "will," "anticipated,"
"intended" and variations of these words or similar expressions are
intended to identify forward-looking statements. In addition, any
statements that refer to expectations, goals, projections or other
characterizations of future events or circumstances, including any
underlying assumptions, are forward-looking statements. These statements
are not guarantees of future performance and are subject to risks,
uncertainties and assumptions that are difficult to predict. Therefore, our
actual results could differ materially and adversely from those expressed
in any forward-looking statements as a result of various factors, including
changes in demand for ZADAXIN, developments in our dispute with SPKK, the
progress or failure of clinical trials, our actual experience in executing
on our objectives, the performance of our partners, maintenance of the
sufficiency and eligibility of the enrolled patient population,
unanticipated delays or additional expenses incurred during our clinical
trials, our future cash requirements, delays in analyzing and synthesizing
data obtained from clinical trials, future actions of our strategic
partners, unexpected delays in preparation for enrollment, future actions
by the U.S. Food and Drug Administration or equivalent regulatory
authorities in Europe and the fact that experimental data and clinical
results derived from studies with a limited group of patients may not be
predictive of the results of larger studies, as well as other risks and
uncertainties described in SciClone's filings with the Securities and
Exchange Commission.
SCICLONE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three months ended Year ended
December 31, December 31,
2005 2004 2005 2004
------------ ------------ ------------ ------------
Product sales $ 7,314,000 $ 5,985,000 $ 27,842,000 $ 22,765,000
Contract revenue 90,000 134,000 492,000 1,631,000
------------ ------------ ------------ ------------
Total revenues 7,404,000 6,119,000 28,334,000 24,396,000
Cost of product
sales 1,375,000 1,148,000 4,875,000 4,577,000
------------ ------------ ------------ ------------
Gross margin 6,029,000 4,971,000 23,459,000 19,819,000
Operating
expenses:
Research and
development 3,213,000 4,442,000 14,406,000 17,994,000
Sales and
marketing 2,809,000 2,375,000 10,237,000 9,665,000
General and
administrative 1,944,000 1,289,000 7,457,000 6,311,000
------------ ------------ ------------ ------------
Total operating
expenses 7,966,000 8,106,000 32,100,000 33,970,000
------------ ------------ ------------ ------------
Loss from
operations (1,937,000) (3,135,000) (8,641,000) (14,151,000)
Interest and
investment
income (1) 386,000 901,000 1,273,000 1,285,000
Interest expense (74,000) (90,000) (345,000) (361,000)
Other income
(expense), net 0 (31,000) 0 (51,000)
------------ ------------ ------------ ------------
Net loss $ (1,625,000) $ (2,355,000) $ (7,713,000) $(13,278,000)
============ ============ ============ ============
Basic and
diluted net
loss per share $ (0.04) $ (0.05) $ (0.17) $ (0.30)
============ ============ ============ ============
Weighted average
shares used in
computing basic
and diluted net
loss per share 45,870,046 44,672,140 45,328,714 44,626,337
============ ============ ============ ============
(1) For the three months and year ended December 31, 2004, interest and
investment income included an approximate gain of $697,000 from sale
of equity securities
SCICLONE PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
ASSETS
December 31, December 31,
2005 2004
------------ ------------
(unaudited)
Current assets:
Cash and cash equivalents $ 25,845,000 $ 41,204,000
Restricted short-term investments 692,000 700,000
Other short-term investments 15,719,000 9,395,000
Accounts receivable, net of allowance of
$82,000 in 2005 and $452,000 in 2004 9,701,000 10,279,000
Inventories 3,272,000 4,179,000
Prepaid expenses and other current assets 1,890,000 1,478,000
------------ ------------
Total current assets 57,119,000 67,235,000
Property and equipment, net 380,000 398,000
Intangible assets, net 472,000 542,000
Other assets 1,544,000 1,534,000
------------ ------------
Total assets $ 59,515,000 $ 69,709,000
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 626,000 $ 1,733,000
Accrued compensation and employee benefits 2,028,000 2,177,000
Accrued professional fees 642,000 452,000
Other accrued expenses 1,687,000 1,409,000
Accrued clinical trials expense 1,658,000 1,500,000
Deferred revenue 211,000 537,000
Convertible notes payable 1,600,000 4,000,000
------------ ------------
Total current liabilities 8,452,000 11,808,000
Deferred revenue - 134,000
Other long-term liabilities - 1,044,000
Convertible note payable - 1,600,000
Commitments and contingencies
Stockholders' equity:
Preferred stock; $0.001 par value;
10,000,000 shares authorized; no
shares outstanding in 2005 and 2004 - -
Common stock; $0.001 par value; 75,000,000
shares authorized; 45,877,420 and
44,677,845 shares issued and outstanding
in 2005 and 2004, respectively 46,000 45,000
Additional paid-in capital 210,245,000 206,608,000
Accumulated other comprehensive income 53,000 38,000
Accumulated deficit (159,281,000) (151,568,000)
------------ ------------
Total stockholders' equity 51,063,000 55,123,000
------------ ------------
Total liabilities and stockholders' equity $ 59,515,000 $ 69,709,000
============ ============
SCICLONE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Year ended
December 31,
2005 2004
------------ ------------
Operating activities:
Net loss $ (7,713,000) $(13,278,000)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization 230,000 215,000
Non-cash expense related to employee stock
options 472,000 -
Other non-cash (income) expense, net (15,000) (3,000)
Gain on sale of equity investment - (697,000)
Changes in operating assets and liabilities:
Accounts receivable 578,000 (137,000)
Inventories 907,000 1,599,000
Prepaid expenses and other assets (447,000) 952,000
Accounts payable and other accrued
expenses (1,329,000) (912,000)
Accrued compensation and employee
benefits (693,000) 737,000
Accrued clinical trials expense 159,000 (389,000)
Accrued professional fees 190,000 (29,000)
Deferred revenue (460,000) (537,000)
Long-term liabilities - 144,000
------------ ------------
Net cash used in operating activities (8,121,000) (12,335,000)
------------ ------------
Investing activities:
Purchases of property and equipment (119,000) (196,000)
Purchases of short-term investments, net (6,285,000) 547,000
------------ ------------
Net cash (used in) provided by investing
activities (6,404,000) 351,000
------------ ------------
Financing activities:
Proceeds from issuances of common stock,
net of financing costs 3,166,000 289,000
Repayment of convertible note (4,000,000) -
------------ ------------
Net cash (used in) provided by financing
activities (834,000) 289,000
------------ ------------
Net decrease in cash and cash equivalents (15,359,000) (11,695,000)
Cash and cash equivalents, beginning of year 41,204,000 52,899,000
------------ ------------
Cash and cash equivalents, end of year $ 25,845,000 $ 41,204,000
============ ============
Corporate contact:
Becky Horner
Investor Relations
SciClone Pharmaceuticals, Inc.
650-358-3437
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