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SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Form 10-K
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þ
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ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
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For the fiscal year ended December 31, 2004 |
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or |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
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For the transition period
from to |
Commission file number 0-29993
IntraBiotics Pharmaceuticals, Inc.
(Exact name of Registrant as specified in its charter)
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Delaware
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94-3200380 |
(State or Other Jurisdiction of
Incorporation or Organization) |
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(IRS Employer
Identification No.) |
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2483 East Bayshore Road,
Suite 100, Palo Alto, CA
(Address of principal executive offices) |
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94303
(Zip code) |
Registrants telephone number, including area code:
(650) 526-6800
Securities registered under Section 12(b) of the
Exchange Act:
None.
Securities registered under Section 12(g) of the
Exchange Act:
Common Stock, par value $.001 per share
(Title of Class)
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of
the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been
subject to such filing requirements for the past
90 days. Yes þ No o
Indicate by check mark if disclosure of delinquent filers
pursuant to Item 405 of Regulation S-K is not
contained herein, and will not be contained, to the best of
registrants knowledge, in definitive proxy or information
statements incorporated by reference in PART III of this
Form 10-K or any amendment to this
Form 10-K. þ
Indicate by check mark whether the registrant is an accelerated
filer (as defined in Rule 12b-2 of the Securities Exchange
Act of
1934). Yes o No þ
The aggregate market value of the Common Stock, held by
non-affiliates of the registrant, based on the closing price on
June 30, 2004 as reported by the NASDAQ National Market was
approximately $24,571,000. The determination of affiliate status
for the purposes of this calculation is not necessarily a
conclusive determination for other purposes. The calculation
excludes approximately 2,527,000 shares held by directors,
officers and stockholders whose ownership exceeds five percent
of the Registrants outstanding common stock as of
June 30, 2004. Exclusion of these shares should not be
construed to indicate that such person controls, is controlled
by or is under common control with the Registrant. The number of
shares outstanding of the registrants Common Stock, par
value $0.001 per share, as of February 28, 2005 was
9,067,645 shares.
TABLE OF CONTENTS
PART I
This report contains forward-looking statements. These
forward-looking statements are based on our current
expectations, estimates, projections and assumptions about our
business and industry. In some cases, these statements may be
identified by terminology such as may,
will, should, expects,
plans, anticipates,
believes, estimates,
predicts, potential or
continue, or the negative of such terms and other
comparable terminology. These statements involve known and
unknown risks and uncertainties that may cause our or our
industrys results, levels of activity, performance or
achievements to be materially different from those expressed or
implied by the forward-looking statements. Factors that may
cause or contribute to such differences include, among others,
those discussed under the captions Business,
Factors That Could Affect Future Results and
Managements Discussion and Analysis of Financial
Condition and Results of Operations. Except as required by
law, we undertake no obligation to update any forward-looking
statement to reflect events after the date of this report.
Overview
Since inception in 1994, we have devoted substantially all of
our efforts to research and development of anti-microbial drugs
and have generated no product revenues. From the fourth quarter
of 2002 until June 2004, we focused our efforts on developing
iseganan for the prevention of ventilator-associated pneumonia
(VAP). In June 2004, we discontinued our clinical
trial of iseganan for the prevention of VAP following a
recommendation of the independent data monitoring committee. We
have since terminated our iseganan development program, reduced
employee headcount by 60% to six employees and are now
evaluating our strategic options, including mergers,
acquisitions, in-licensing opportunities, and liquidation of the
Company. We have retained the investment banking firm, Lazard,
to advise the Company in evaluating its strategic options. Our
future operations and financial condition will depend on the
strategic alternative we elect to pursue. To date, our efforts
have been focused on strategic options in the biotechnology and
pharmaceutical industries. See Note 7 of the notes to the
financial statements included in Item 8 of this
Form 10-K for additional information concerning our
restructuring efforts in 2004.
On December 31, 2004, the Company had a total of
$50.7 million in cash, cash equivalents, and short-term
investments, and recorded liabilities of $0.7 million.
Clinical Supplies and Manufacturing
We have no manufacturing capabilities. We relied on third-party
manufacturers to produce our products in clinical and commercial
quantities to support our iseganan development programs.
Clinical Pipeline
Prior to the termination of our iseganan development program our
clinical pipeline had included development of an iseganan oral
solution for the prevention of ventilator-associated pneumonia
and for the treatment of respiratory infections in cystic
fibrosis patients. We currently have no clinical pipeline. Our
research and development expenditures will depend upon the
strategic alternative we elect to pursue.
Research and development expense for the three years ended
December 31, 2004, 2003 and 2002 was $11.5 million,
$7.7 million and $23.1 million, respectively.
Marketing and Sales
Currently, we have no marketing and sales capability, and have
no current plans to develop any. Our strategy for marketing and
sales will depend upon the strategic alternative we elect to
pursue.
1
Competition
The biotechnology and pharmaceutical industries are extremely
competitive. Many companies have substantially greater financial
and other resources than we do. In addition, they may have
substantially more experience in effecting strategic
combinations, in-licensing technology, developing drugs,
obtaining regulatory approvals, and manufacturing and marketing
products. We cannot give any assurances that we can effectively
compete with these other pharmaceutical and biotechnology
companies.
Intellectual Property
In April 1994, we entered into a license agreement (the
License Agreement) with the Regents of the
University of California, (the Regents) under which
we obtained exclusive rights to develop and commercialize
Protegrin-based products, such as iseganan. We terminated this
License Agreement in December 2004 and re-assigned to the
Regents its previously owned undivided ownership interest in
certain joint patent rights. As owner of an interest in these
patent rights, the Regents would be free to license such rights
to any third party and would not be required to compensate us. A
number of provisions in the License Agreement survive including
confidentiality, restrictions on using either partys names
or trademarks, attorneys fees in the event of a dispute,
maintenance of books and records and certain indemnification
obligations.
Government Regulation
Governmental authorities in the U.S. and other countries
extensively regulate, among other things, the research,
development, testing, manufacture, labeling, promotion,
advertising, distribution, and marketing, of products produced
by the biotechnology and pharmaceutical industry. In the United
States the Food and Drug Administration (the FDA)
regulates drugs under the Federal Food, Drug, and Cosmetic Act
and its implementing regulations. Outside the U.S., the
requirements governing conduct of clinical trials and marketing
authorization vary widely from country to country, but involve a
similar degree of oversight and rigor as in the U.S.
Employees
As of February 28, 2005, we had six full-time employees.
Our employees are not represented by a collective bargaining
agreement. We believe that we have good relations with our
employees.
Available Information
Our website address is www.intrabiotics.com. We make available
free of charge through our website, our annual report on
Form 10-K, quarterly reports on Form 10-Q, current
reports on Form 8-K, and all amendments to these reports as
soon as reasonably practicable after filing.
2
We currently lease one facility at 2483 East Bayshore Road,
Suite 100, in Palo Alto, California. The facility provides
approximately 3,600 square feet of office space. The lease
expires on June 30, 2005 and includes an option to extend
until December 31, 2005. This facility is adequate for our
current needs.
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| Item 3. |
Legal Proceedings |
(a) Beginning on July 2, 2004, three purported class
action shareholder complaints were filed in the United States
District Court for the Northern of California against
IntraBiotics and several of its officers. The actions were
consolidated and a consolidated amended complaint has been
filed, purportedly brought on behalf of purchasers of
IntraBiotics common stock between September 5, 2003 and
June 22, 2004. The amended complaint generally alleges that
IntraBiotics and several of its officers and directors made
false or misleading statements concerning the clinical trial of
iseganan. The plaintiffs seek unspecified monetary damages. On
February 28, 2005, the Company and the individual
defendants filed a motion to dismiss the amended complaint. The
Company believes the suit to be without merit and intends to
defend itself vigorously. Due to the uncertainties surrounding
the final outcome of this matter, no amounts have been accrued
at December 31, 2004.
(b) No legal proceedings were terminated in the fourth
quarter.
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| Item 4. |
Submission of Matters to a Vote of Security Holders |
No matters were submitted to a vote of stockholders through the
solicitation of proxies or otherwise during the three-month
period ended December 31, 2004.
PART II
Item 5. Market for
Registrants Common Equity, Related Stockholder Matters and
Issuer Purchases of Equity Securities
Market for Common Equity
Our common stock began trading on the NASDAQ National Market on
March 28, 2000, under the symbol IBPI. Prior to
that time, there had been no public market for our common stock.
We effected a 1:12 reverse stock split on April 10,
2003. All amounts herein have been retroactively adjusted to
reflect this stock split. The table below sets forth the high
and low bid prices for our common stock for the periods
indicated:
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High | |
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Low | |
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1st Quarter ended March 31, 2003
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$ |
4.08 |
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$ |
1.56 |
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2nd Quarter ended June 30, 2003
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$ |
6.48 |
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$ |
1.54 |
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3rd Quarter ended September 30, 2003
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$ |
15.60 |
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$ |
3.08 |
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4th Quarter ended December 31, 2003
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$ |
17.50 |
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$ |
10.50 |
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1st Quarter ended March 31, 2004
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$ |
19.25 |
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$ |
13.25 |
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2nd Quarter ended June 30, 2004
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$ |
18.00 |
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$ |
3.70 |
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3rd Quarter ended September 30, 2004
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$ |
4.38 |
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$ |
3.35 |
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4th Quarter ended December 31, 2004
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$ |
4.20 |
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$ |
3.46 |
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As of February 28, 2005, there were 123 holders of record
of common stock. We estimate that, included within the holders
of record, there are approximately 3,000 beneficial owners of
common stock. As of February 28, 2005, the closing price
for our common stock was $3.79.
3
Dividend Policy
We have never paid dividends on our common stock. We currently
intend to retain any future earnings to support the development
of our business. The holders of our Series A preferred
stock are entitled to receive cumulative dividends at the rate
of 8% per annum of the original purchase price of
$10,000 per share of Series A preferred stock, prior
to and in preference to any declaration or payment of a dividend
to the holders of common stock. The dividends are payable
quarterly in shares of common stock. The number of shares
payable is determined based on the average closing sale price of
the common stock on the NASDAQ National Market, or other market
on which our common stock is traded, for each of the five
trading days immediately preceding the applicable dividend
payment date. Until accrued and unpaid dividends on the
Series A preferred stock are paid and set apart, no
dividends or other distributions in respect of any other shares
of our capital stock shall be declared. We do not currently
anticipate paying any cash dividends in the foreseeable future.
4
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| Item 6. |
Selected Financial Data |
The following selected financial data should be read in
conjunction with our financial statements and
Managements Discussion and Analysis of Financial
Condition and Results of Operations included in
Items 7 and 8 of this report. The financial data for
periods prior to the financial statements presented in
Item 8 of this Form 10-K are derived from audited
financial statements not included in this Form 10-K.
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Year Ended December 31, | |
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2004 | |
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2003 | |
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2002 | |
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2001 | |
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2000 | |
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(In thousands, except per share amounts) | |
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Statement of Operations Data:
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Operating expenses:
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Research and development
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$ |
11,519 |
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$ |
7,727 |
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$ |
23,053 |
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$ |
38,034 |
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$ |
39,152 |
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General and administrative
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4,819 |
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5,782 |
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8,617 |
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9,202 |
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11,560 |
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Restructuring and other charges
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858 |
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6,118 |
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21,956 |
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Arbitration settlement
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(3,600 |
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Impairment of acquired workforce
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1,365 |
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Total operating expenses
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17,196 |
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13,509 |
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35,553 |
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69,192 |
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50,712 |
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Operating loss
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(17,196 |
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(13,509 |
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(35,553 |
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(69,192 |
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(50,712 |
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Interest income
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700 |
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166 |
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703 |
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2,843 |
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5,699 |
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Interest expense
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(459 |
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(1,110 |
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(563 |
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Other income/(expense), net
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(204 |
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31 |
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856 |
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93 |
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Net loss
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(16,700 |
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(13,312 |
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(34,453 |
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(67,366 |
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(45,576 |
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Non-cash deemed dividend related to beneficial conversion
feature of Series A preferred stock
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(1,436 |
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Non-cash dividends on Series A preferred stock
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(260 |
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(182 |
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Net loss applicable to common stockholders
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$ |
(16,960 |
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$ |
(14,930 |
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$ |
(34,453 |
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$ |
(67,366 |
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$ |
(45,576 |
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Basic and diluted net loss per share applicable to common
stockholders
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$ |
(2.24 |
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$ |
(4.01 |
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$ |
(11.25 |
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$ |
(27.47 |
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$ |
(24.29 |
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Shares used to compute basic and diluted net loss per share
applicable to common stockholders
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7,559 |
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3,720 |
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3,064 |
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2,453 |
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1,876 |
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Balance Sheet Data:
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Cash, cash equivalents, restricted cash and short-term
investments
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$ |
50,743 |
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$ |
26,644 |
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$ |
13,315 |
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$ |
35,470 |
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$ |
86,065 |
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Working capital
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50,462 |
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25,424 |
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15,191 |
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29,629 |
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86,142 |
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Total assets
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51,185 |
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27,326 |
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16,226 |
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42,465 |
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108,288 |
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Long term obligations, less current portion
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5,000 |
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8,309 |
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Accumulated deficit
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(232,159 |
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(215,199 |
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(200,269 |
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(165,816 |
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(98,450 |
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Total stockholders equity
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50,508 |
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25,628 |
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15,480 |
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26,212 |
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89,955 |
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5
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| Item 7. |
Managements Discussion and Analysis of Financial
Condition and Results of Operations |
The following discussion and analysis of our financial
condition and results of operations should be read together with
our financial statements and related notes appearing elsewhere
in this Form 10-K. This discussion and analysis contains
forward-looking statements that involve risks, uncertainties and
assumptions. The actual results may differ materially from those
anticipated in these forward-looking statements as a result of
many factors, including but not limited to those set forth under
Factors That Could Affect Future Results. All
forward-looking statements included in this document are based
on information available to us on the date of this document and
we assume no obligation to update any forward-looking statements
contained in this Form 10-K.
Overview
Since inception in 1994, we have devoted substantially all of
our efforts to research and development of anti-microbial drugs,
and have generated no product revenues. From the fourth quarter
of 2002 until June 2004, we focused our efforts on developing
iseganan for the prevention of ventilator-associated pneumonia
(VAP). In June 2004, we discontinued our clinical
trial of iseganan for the prevention of VAP following a
recommendation of the independent data monitoring committee. We
have since terminated our iseganan development program and in
August 2004, the Company implemented a restructuring plan, which
included the termination of nine employees and various operating
lease commitments. We have six employees and occupy one office
facility in Palo Alto, California.
We are evaluating our strategic options, including
mergers, acquisitions, in-licensing opportunities, and
liquidation of the Company. We have retained the investment
banking firm, Lazard, to advise the Company in evaluating its
strategic options. Our future operations and financial condition
will depend on the strategic alternative that we elect to
pursue. On December 31, 2004, the Company had a total of
$50.7 million in cash, cash equivalents, and short-term
investments, and recorded liabilities of $0.7 million.
Based on current projections, the Company expects cash outflows
of between $2.5 million and $3.5 million during 2005.
This estimate does not include any costs that may be associated
with completing a merger, acquisition, in-license opportunity,
liquidation of the Company or the disposition of the securities
litigation referred to in Item 3 (a) of this
Form 10-K. There can be no assurance that such a range will
be achieved, as actual expenditures and interest income may
differ significantly from projected levels.
In February 2003, the Board of Directors approved a cancellation
and re-grant of 308,835 unexercised stock options held by
existing employees and directors of the Company in a one-for-one
exchange and 12,500 options that were re-granted in connection
with the cancellation of 54,166 unexercised stock options held
by a director of the Company. The re-granted options have an
exercise price equal to the closing price of the Companys
common stock on the NASDAQ National Market on February 5,
2003, or $2.76 per share. The options generally vest over a
four-year period and will expire in February 2008 if not
previously exercised. Variable accounting is being applied to
the re-granted options throughout their term. The related
compensation expense depends on both the cumulative vesting of
outstanding options and the price of the Companys common
stock at each quarter end, and therefore may have a significant
impact on the Companys future results of operations. In
2004, we recorded a non-cash stock compensation recovery of
$638,000 as compared to a non-cash stock compensation expense of
$1.0 million during 2003 in connection with variable
accounting for re-granted stock options. In addition, we
recorded non-cash stock compensation expense related to the
amortization of deferred stock compensation of $61,000, $126,000
and $1.3 million during the years ended December 31,
2004, 2003 and 2002, respectively, primarily in connection with
the grant of certain stock options to employees and officers on,
or prior to, the Companys initial public offering on
March 20, 2000. In addition, we have granted stock options
to consultants, which resulted in non-cash stock compensation
expense of $472,000, $254,000 and $512,000 during the years
ended December 31, 2004, 2003 and 2002, respectively. In
addition, in connection with the issuance of shares of common
stock the Company recorded compensation expense of $545,000
based on the fair market value of the common stock on the date
of issuance during the year ended December 31, 2002. This
expense was recorded primarily in connection with stock issued
to a former landlord of the Company in connection with a
restructuring. For additional details and a
6
tabular summary of stock compensation expense see Note 10
of the notes to the financial statements included in Item 8
of this Form 10-K.
We intend that the following discussion of our results of
operations and financial condition will provide information to
assist in the understanding of our financial statements, the
changes in certain key items in those financial statements from
year to year, and the primary factors that accounted for those
changes, as well as how certain accounting principles, policies
and estimates affect our financial statements.
Critical Accounting Policies and Estimates
An accounting policy is deemed to be critical if it requires an
accounting estimate to be made based on assumptions about
matters that are highly uncertain at the time the estimate is
made, and if different estimates that reasonably could have been
used, or changes in the accounting estimates that are reasonably
likely to occur periodically, could materially impact the
financial statements. Management believes the following critical
accounting policies reflect its more significant estimates and
assumptions used in the preparation of the financial statements.
We review the accounting policies used in our financial
statements on a regular basis. In addition, management has
reviewed these critical accounting policies and related
disclosures with our Audit Committee.
Our discussion and analysis of our financial condition and
results of operations is based upon our financial statements,
which have been prepared in accordance with accounting
principles generally accepted in the United States of America.
The preparation of these financial statements requires
management to make estimates and judgments that affect the
reported amounts of assets, liabilities and expenses, and
related disclosures. On an ongoing basis, we evaluate these
estimates, including those related to clinical trial accruals,
income taxes (including the valuation allowance for deferred tax
assets), restructuring costs and stock-based compensation.
Estimates are based on historical experience, information
received from third parties and on various other assumptions
that are believed to be reasonable under the circumstances, the
results of which form the basis for making judgments about the
carrying values of assets and liabilities that are not readily
apparent from other sources. Actual results could therefore
differ materially from those estimates under different
assumptions or conditions.
In February 2003, the Board of Directors approved a cancellation
and re-grant of 308,835 unexercised stock options held by
existing employees and directors of the Company in a one-for-one
exchange and 12,500 options that were re-granted in connection
with the cancellation of 54,166 unexercised stock options held
by a director of the Company. The re-granted options have an
exercise price equal to the closing price of the Companys
common stock on the NASDAQ National Market on February 5,
2003, or $2.76 per share. The options generally vest over a
four-year period and will expire in February 2008 if not
previously exercised. Variable accounting is being applied to
the re-granted options throughout their term. The related
compensation expense depends on both the cumulative vesting of
outstanding options and the price of the Companys common
stock at each quarter end, and therefore may have a significant
impact on the Companys future results of operations. No
adjustments for material changes in estimates have been
recognized in any period presented.
As permitted by Statement of Financial Accounting Standards
No. 123 (SFAS 123), Accounting
for Stock-Based Compensation, as amended by Statement
of Financial Standards No. 148, Accounting for
Stock-Based Compensation Transition and
Disclosure, the Company has elected to follow
APB 25 and related interpretations in accounting for
stock-based employee compensation. Under APB 25, if the
exercise price of an employee or director stock option is set
equal or in excess of the fair market value of the underlying
stock on the date of grant, no compensation expense is
recognized. In February 2003, certain employee and director
stock options for which the exercise prices had originally been
set at less than the fair market value of the underlying stock
on the grant date, were cancelled and re-granted in a
one-for-one exchange. The Company had recorded deferred
compensation for the difference between the original exercise
price and the fair market value of the underlying stock on the
grant date as a component of stockholders equity, and the
7
total was being amortized on a straight-line basis over the
vesting period of the original awards, ranging from four to six
years. The related re-granted options all vest over a four-year
period, and the remaining unamortized deferred compensation as
of the re-grant date is now being amortized over the new
four-year vesting schedule, commencing at the date of re-grant.
The amount of deferred stock compensation expense to be recorded
in future periods could decrease if options, for which accrued
but unvested compensation has been recognized, are forfeited
prior to vesting. No adjustments for material changes in
estimates have been recognized in any period presented.
Options or stock awards issued to non-employees are recorded at
their fair value as determined in accordance with SFAS 123
and the FASBs Emerging Issues Task Force issue
No. 96-18, Accounting for Equity Instruments That
Are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services, and are
recognized over the related service period and are periodically
re-measured as the underlying options vest. The fair values are
estimated using the Black-Scholes option pricing model, and are
periodically re-measured as the underlying options vest. The
option pricing model is dependent on a number of inputs, which
may change over time. Other option pricing models may produce
fair values that are substantially different from the
Black-Scholes model. No adjustments for material changes in
estimates have been recognized in any period presented.
The Companys accrued costs for clinical trial activities
are based upon estimates of the services received and related
expenses incurred that have yet to be invoiced by the contract
research organizations (CROs), investigators, drug processors,
laboratories, consultants, or other clinical trial service
providers that perform the activities. Related contracts vary
significantly in length, and may be for a fixed amount, a
variable amount based on actual costs incurred, capped at a
certain limit, or for a combination of these elements. Activity
levels are monitored through close communication with the
service provider, including detailed invoice and task completion
review, analysis of expenses against budgeted amounts, and
pre-approval of any changes in scope of the services to be
performed. Each CRO provides an estimate of costs incurred but
not invoiced at the end of each period for each individual
trial. The estimates are reviewed and discussed with the CRO as
necessary, and included in research and development expenses for
the related period. For investigator study grants, which are
paid quarterly on a per-patient basis to the institutions
performing the clinical study, the Company accrues an estimated
amount based on patient enrollment in each quarter. All
estimates may differ significantly from the actual amount
subsequently invoiced. No adjustments for material changes in
estimates have been recognized in any period presented. As of
December 31, 2004 amounts accrued related to clinical
trials are approximately $161,000, due to the cessation of
clinical trial activity.
Results of Operations
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|
|
Comparison of Years Ended December 31, 2004, 2003 and
2002 |
IntraBiotics had no product sales or contract revenue for the
years ended December 31, 2004, 2003 and 2002. We do not
anticipate any product revenues until we obtain FDA approval
for, and commence commercialization of, any product candidate.
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| |
|
2004 | |
|
Change | |
|
2003 | |
|
Change | |
|
2002 | |
| |
|
| |
|
| |
|
| |
|
| |
|
| |
| |
|
(In thousands) | |
|
Research and development
|
|
$ |
11,519 |
|
|
|
49.1 |
% |
|
$ |
7,727 |
|
|
|
(66.5 |
)% |
|
$ |
23,053 |
|
Research and development expenses primarily include clinical
trial expenses, research and development payroll expense, drug
substance expense, allocated facilities costs and non-cash stock
compensation charges. Research and development expenses
increased in 2004 by $3.8 million from 2003. These expenses
increased
8
by $0.4 million as a result of additional headcount and by
$3.4 million from clinical trial expenses associated with
the commencement of phase III trials of iseganan for the
prevention of VAP. Although these expenses increased during
2004, as compared to 2003, $8.9 million of the total
expense was incurred in the first half of 2004, with only
$2.1 million and $0.6 million of research and
development expense in the third and fourth quarters of 2004,
respectively. This significant reduction in the fourth quarter
is as a result of the termination of our iseganan development
project in June 2004.
Research and development expenses decreased in 2003 by
$15.3 million from 2002, primarily due to a
$9.3 million reduction in clinical trial expenses and a
$3.2 million reduction in research and development payroll
expense, allocated facilities costs and non-cash stock
compensation charges as a result of restructuring activities in
2002. The clinical trial expenses of $4.3 million in 2003
relate to the first pivotal trial of iseganan for the prevention
of VAP, which commenced in September 2003
In 2003, research and development expenses include a write-off
of $2.4 million for prepaid iseganan drug substance,
relating to an order of seven kilograms of iseganan bulk drug
substance that was expected to be delivered in 2003. Due to
significant uncertainty over the timing and outcome of
discussions with the contract manufacturer about whether the
drug substance was manufactured in accordance with a validation
plan and the adequacy of manufacturing documentation, the entire
$2.4 million prepaid amount was written off in September
2003. In 2002, research and development expenses included a
$4.8 million charge in relation to the delivery of certain
other lots of iseganan bulk drug substance as a result of the
termination of a supply agreement with the same contract
manufacturer.
Non-cash stock compensation charges were $26,000, $59,000 and
$656,000 for the years ended December 31, 2004, 2003 and
2002, respectively. The decrease from 2003 to 2004 was due to
lower amortization of deferred stock compensation expense during
2004 and a recovery related to stock compensation for variable
options awards during 2004, as compared to an expense during
2003. These decreases were offset, in part, by an increase in
the stock compensation expense for consultant services. The
decrease from 2002 to 2003 was primarily due to the cancellation
of options for terminated employees and consultants.
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General and Administrative |
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| |
|
2004 | |
|
Change | |
|
2003 | |
|
Change | |
|
2002 | |
| |
|
| |
|
| |
|
| |
|
| |
|
| |
| |
|
(In thousands) | |
|
General and administrative
|
|
$ |
4,819 |
|
|
|
(16.7 |
)% |
|
$ |
5,782 |
|
|
|
(32.9 |
)% |
|
$ |
8,617 |
|
General and administrative costs primarily include
administrative payroll expense, outside contractors, legal and
accounting fees, insurance, non-cash stock compensation charges,
facilities, travel and other general administrative expenses.
General and administrative expenses decreased by
$1.0 million from 2003 to 2004. Expenses associated with
increased headcount and facilities increased by
$0.4 million, which was offset by a reduction in stock
compensation expense of $1.4 million primarily related to
variable accounting for stock options. During 2003 stock
compensation charges were $1.3 million as compared with a
recovery of $0.1 million during 2004.
General and administrative expenses in 2003 decreased by
$2.8 million from 2002, primarily due to reduced headcount
and facility-related costs as a result of a restructuring in
October 2002.
Non-cash stock compensation charges were a recovery in the year
ended December 31, 2004 of $0.1 million as compared to
expenses of $1.3 million and $1.7 million for the
years ended December 31, 2003 and 2002, respectively.
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Restructuring and Other Charges |
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|
|
| |
|
2004 | |
|
2003 | |
|
2002 | |
| |
|
| |
|
| |
|
| |
| |
|
(In thousands) | |
|
Restructuring and other charges
|
|
|
$858 |
|
|
|
$ |
|
|
|
$6,118 |
|
In June 2004, the Company discontinued its clinical trial of
iseganan for the prevention of VAP, following a recommendation
of the independent data monitoring committee. The Company has
since terminated its
9
iseganan development program, and is focusing efforts on
evaluating various strategic options, which may include mergers,
acquisitions, in-licensing opportunities, and liquidation of the
Company. As a result, in August 2004, the Company implemented a
restructuring plan, which included the termination of nine
employees and various operating lease commitments.
The Company recorded a restructuring charge of $858,000 during
the year ended December 31, 2004, of which $748,000 related
to involuntary employee termination benefits and $110,000
related to the termination of facility operating leases and the
write-off of certain property and equipment. The $748,000 of
involuntary employee benefits were comprised of $700,000 of lump
sum severance payments, $13,000 of related employer taxes and
$35,000 of health and other benefits payable. As of
December 31, 2004, approximately $5,000 of the
restructuring charge remained unpaid and is included under the
caption Other Accrued Liabilities on the
accompanying balance sheet. The remaining liability should be
settled by June 30, 2005.
There were no restructurings during 2003.
In 2002, restructuring expense of $6.1 million was
comprised of two components. The first component was as a result
of the failure of a phase III clinical trial of iseganan
for the prevention of oral mucositis in cancer patients, which
occurred in October 2002. As a result of this restructuring we
reduced our headcount to 11 as of December 31, 2002 from 37
as of December 31, 2001 and recorded an expense of
$848,000. The second component of $5.2 million was as a
result of an additional expense related to a previous
restructuring which occurred during 2001. The additional expense
of $5.2 million related to the termination of a lease and
related sublease and included cash payments, the issuance of
common stock and the write-off of a deferred rent balance.
During the year ended December 31, 2002, we received
$3.6 million from a contract vendor as a result of an
arbitration settlement relating to a drug dispensing error in a
phase III trial of iseganan for oral mucositis. We had no
comparable item in 2004 or 2003.
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Interest Income and Expense |
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| |
|
2004 | |
|
Change | |
|
2003 | |
|
Change | |
|
2002 | |
| |
|
| |
|
| |
|
| |
|
| |
|
| |
| |
|
(In thousands) | |
|
Interest income
|
|
$ |
656 |
|
|
|
295.2 |
% |
|
$ |
166 |
|
|
|
(76.4 |
)% |
|
$ |
703 |
|
|
Interest expense
|
|
$ |
|
|
|
|
n/m |
|
|
$ |
|
|
|
|
(100.0 |
) |
|
|
(459 |
) |
Interest income in 2004 increased from 2003 because of
substantially higher average interest earning investment
balances due to a public stock offering in May 2004, which
raised net proceeds of $41.5 million. Interest income
decreased in 2003, as compared to 2002, primarily as a result of
decreases in average investment balances and lower interest
rates in each year. For additional information on the public
stock offering in May 2004 please see Liquidity and Capital
Resources, below.
Interest expense decreased to zero in 2003 due to the repayment
of our line of credit and bank loan in October 2002.
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|
Other Income/(Expense), net |
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|
|
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|
|
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|
|
|
|
|
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| |
|
2004 | |
|
Change | |
|
2003 | |
|
Change | |
|
2002 | |
| |
|
| |
|
| |
|
| |
|
| |
|
| |
| |
|
(In thousands) | |
|
Other income/(expense), net
|
|
$ |
(175 |
) |
|
|
(564.5% |
) |
|
$ |
31 |
|
|
|
(96.4 |
)% |
|
$ |
856 |
|
In September 2004 the Company recorded an expense, included in
other income/(expense), net, of $175,000 related to the
write-down of the carrying value of 350,000 shares of
Series A redeemable preferred stock of Micrologix Biotech
Inc., (Micrologix).
Other income/(expense), net in 2002 includes income of $975,000
from the sale of two pre-clinical anti-infective programs to
Micrologix in May 2002, for $400,000 in cash and
750,000 shares of Series A
10
redeemable preferred stock of Micrologix. The shares are
redeemable at $1 per share or convertible into common stock
at the election of Micrologix upon the occurrence of certain
time and achievement milestones as follows: (1) shares
converted into common stock with a value of $400,000 upon the
four month anniversary of the effective date of the agreement;
(2) shares will convert into common stock with a value of
$100,000 upon commencement of certain toxicology studies; and
(3) shares will convert into common stock with a value of
$250,000 upon filing for marketing approval for certain drugs in
certain countries. Other income of $775,000 was recognized in
the second quarter of 2002 upon receipt of the $400,000 in cash
and the 750,000 shares, and other income of $200,000 was
recognized in the third quarter of 2002 upon redemption of
400,000 of the shares at $1 per share, which was triggered
by the first milestone set forth above. Subsequent to this
redemption the Company owned 350,000 shares of
Series A redeemable preferred stock with a carrying value
of $175,000 which were included in Other Assets.
Income Taxes
Since inception, we have incurred operating losses and
accordingly have not recorded a provision for income taxes for
any of the periods presented. As of December 31, 2004, we
had net operating loss carryforwards for federal and state
income tax purposes of approximately $211.0 million and
$38.0 million, respectively. We also had federal and state
research and development tax credits each of approximately
$3.3 million. If not utilized, the net operating losses and
credits will expire in the years 2004 through 2024. Utilization
of net operating losses and credits are subject to a substantial
annual limitation due to ownership change limitations provided
by the Internal Revenue Code of 1986, as amended. The annual
limitation could result in the expiration of our net operating
losses and credit carryforwards before they can be used. Please
read Note 12 of the notes to the financial statements
included in Item 8 of this Form 10-K for further
information.
Liquidity and Capital Resources
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| |
|
2004 | |
|
Change | |
|
2003 | |
|
Change | |
|
2002 | |
| |
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