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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) | |
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
|
|
|
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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
|
|
|
General and Administrative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
|
|
|
Restructuring and Other Charges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
|
|
|
Interest Income and Expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
|
|
|
Other Income/(Expense), net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
Change | |
|
2003 | |
|
Change | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(Dollars in thousands) | |
Cash, cash equivalents, restricted cash and short-term
investments
|
|
$ |
50,743 |
|
|
|
90.4 |
% |
|
$ |
26,644 |
|
|
|
100.1 |
% |
|
$ |
13,315 |
|
At December 31, 2004, we had cash and cash equivalents of
$1.8 million, representing a decrease of $12.5 million
from December 31, 2003. There was no restricted cash at
December 31, 2004 as compared to $250,000 at
December 31, 2003. Short-term investments were
$49.0 million at December 31, 2004 as compared to
$12.1 million at December 31, 2003. We had no debt
outstanding as of December 31, 2004. We invest excess funds
in short-term money market funds and securities pursuant to our
investment policy guidelines as more fully described in
Item 7A Quantitative and Qualitative
Disclosures About Market Risk. The following is an analysis of
changes in our cash and cash equivalents in each respective year.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Net cash used in operating activities
|
|
$ |
(17,242 |
) |
|
$ |
(8,823 |
) |
|
$ |
(26,347 |
) |
Net cash used in investing activities
|
|
|
(37,043 |
) |
|
|
(9,211 |
) |
|
|
(1,552 |
) |
Net cash provided by financing activities
|
|
|
41,754 |
|
|
|
22,150 |
|
|
|
10,087 |
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
$ |
(12,531 |
) |
|
$ |
4,116 |
|
|
$ |
(17,812 |
) |
|
|
|
|
|
|
|
|
|
|
The net cash used in operating activities increased in 2004 from
2003. The operating cash outflow during 2004 was primarily due
to the net loss of $16.7 million. During 2003 operating
cash outflow was comprised of the net loss of
$13.3 million, offset by non-cash stock compensation
expense of $1.4 million, decreases in prepaid expenses of
$2.1 million and an increase in accrued clinical
liabilities of $1.0 million. The net cash used in operating
activities decreased in 2003 from 2002, primarily due to a
reduction in the net loss from $34.5 million to
$13.3 million, which primarily resulted from lower clinical
trial expenses between the
11
respective years and restructuring charges taken in 2002. We
expect cash outflows from operating activities for the
foreseeable future.
The net cash used in investing activities in 2004 relates to the
purchase of $65.2 million of short-term investments,
partially offset by the maturity of short-term investments of
$28.2 million. The net cash used in investing activities in
2003 relates to the purchase of $12.1 million of short-term
investments, partially offset by the maturity of short-term
investments of $2.9 million. In 2002, the cash used
primarily relates to the purchase of $2.9 million of
short-term investments, partially offset by the proceeds from
the sale of two pre-clinical programs to Micrologix for $800,000.
Historically we have relied upon cash flows from financing
activities to fund our operations. Details of our financing
activities during the last three years are as follows:
|
|
|
|
|
In May 2004, in a public offering on Form S-1, the Company
sold 3,450,000 shares of newly issued common stock,
$0.001 par value, at $13.00 per share resulting in net
cash proceeds of $41.5 million after issuance costs of
$3.3 million. |
|
|
|
In October 2003, in a private placement transaction, the Company
sold 1,774,000 shares of newly issued common stock,
$0.001 par value, at $10.85 per share, and issued
warrants to purchase 354,800 shares of the
Companys common stock, resulting in net cash proceeds of
$18.5 million. The warrants have an exercise price of
$10.85 per share, subject to adjustment upon a subdivision
or combination of the Companys outstanding common stock,
and will expire on October 10, 2008, if not previously
exercised. |
|
|
|
In May 2003, the Company sold 350 shares of a newly created
Series A convertible preferred stock and issued warrants to
purchase 920,699 shares of common stock, resulting in
net cash proceeds of $3.2 million. The warrants have an
exercise price of $2.066 per share, subject to adjustment
upon a subdivision or combination of the Companys
outstanding common stock, and expire in May 1, 2008, if not
previously exercised. |
|
|
|
Cash provided by financing activities in 2002 was primarily due
to net proceeds of approximately $14.0 million and
$5.0 million from two private placements of common stock,
partially offset by $9.4 million in payments on financing
obligations to a bank. |
|
|
|
Cash proceeds from exercises of stock options were $242,000,
$380,000 and $481,000 for the years ended December 31,
2004, 2003 and 2002, respectively. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
|
|
|
|
Less than | |
|
1-3 | |
|
3-5 |
|
More than |
|
|
Total | |
|
1 Year | |
|
Years | |
|
Years |
|
5 Years |
|
|
| |
|
| |
|
| |
|
|
|
|
|
|
(In thousands) |
Operating leases
|
|
$ |
67 |
|
|
$ |
66 |
|
|
$ |
1 |
|
|
$ |
|
|
|
$ |
|
|
Total contractual commitments
|
|
$ |
67 |
|
|
$ |
66 |
|
|
$ |
1 |
|
|
$ |
|
|
|
$ |
|
|
In addition to the contractual commitments listed above we have
various severance plans that cover all of our employees. In
accordance with these plans we may be obligated to make various
severance payments and pay for certain health costs if our
existing employees should be terminated. These commitments
totaled $1.1 million as of December 31, 2004.
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. Based on the number of shares of
preferred stock outstanding as of December 31, 2004 this
equates to $260,000. The dividends are payable quarterly in
shares of common stock, and the number of shares payable are
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
12
applicable dividend payment date. We do not currently anticipate
paying any cash dividends in the foreseeable future.
There were no purchase obligations as of December 31, 2004
that included material penalties for cancellation and were
enforceable and legally binding.
|
|
|
Off-Balance Sheet Arrangements |
We do not have any off-balance sheet arrangements (as that term
is defined in Rule 303 of Regulation S-K) that are
reasonably likely to have a current or future material effect on
our financial condition, results of operations, liquidity,
capital expenditures or capital resources.
In the ordinary course of business, we enter into contractual
arrangements under which we may agree to indemnify the third
party to such arrangement from any losses incurred relating to
the services they perform on behalf of IntraBiotics or for
losses arising from certain events as defined within the
particular contract, which may include, for example, litigation
or claims relating to past performance. Such indemnification
obligations may not be subject to maximum loss clauses.
Historically, payments made related to these indemnifications
have been immaterial. In addition, we have entered into
indemnity agreements with each of our directors and executive
officers. Such indemnity agreements contain provisions, which
are in some respects broader than the specific indemnification
provisions contained in Delaware law. We also maintain an
insurance policy for our directors and executive officers
insuring against certain liabilities arising in their capacities
as such.
|
|
|
Future Capital Requirements |
We expect to continue to incur operating losses and will not
receive any product revenues in the foreseeable future. Our
efforts are focused on pursuing strategic options, including
mergers, acquisitions, in-licensing opportunities, and
liquidation of the Company. 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. We currently
anticipate our cash, cash equivalents and short-term investments
to be sufficient to fund the foregoing efforts for at least the
next 12 months. This forecast is a forward-looking
statement that involves risks and uncertainties, and actual
results could vary.
Recent Accounting Pronouncements
In December 2004, the FASB issued SFAS No. 123
(revised 2004), Share-Based Payment
(SFAS 123R), which replaces
SFAS No. 123, Accounting for Stock-Based
Compensation (SFAS 123) and supersedes
APB Opinion No. 25, Accounting for Stock Issued to
Employees. SFAS 123R requires all share-based
payments to employees, including grants of employee stock
options, to be recognized in the financial statements based on
their fair values, beginning with the first interim or annual
period after June 15, 2005, with early adoption encouraged.
The pro forma disclosures previously permitted under
SFAS 123, no longer will be an alternative to financial
statement recognition. We are required to adopt SFAS 123R
in our third quarter of fiscal 2005, beginning July 1,
2005. Under SFAS 123R, we must determine the appropriate
fair value model to be used for valuing share-based payments,
the amortization method for compensation cost and the transition
method to be used at date of adoption. The transition methods
include prospective and retroactive adoption options. Under the
retroactive options, prior periods may be restated either as of
the beginning of the year of adoption or for all periods
presented. The prospective method requires that compensation
expense be recorded for all unvested stock options and
restricted stock at the beginning of the first quarter of
adoption of SFAS 123R, while the retroactive methods would
record compensation expense for all unvested stock options and
restricted stock beginning with the first period restated. We
are evaluating the requirements of SFAS 123R and we expect
that the adoption of SFAS 123R will have a material impact
13
on our consolidated results of operations and earnings per
share. We have not yet determined the method of adoption or the
effect of adopting SFAS 123R, and we have not determined
whether the adoption will result in amounts that are similar to
the current pro forma disclosures under SFAS 123 shown in
Note 2 of the notes to the financial statements included in
Item 8 of this Form 10-K.
In December 2004, the FASB issued SFAS No. 153,
Exchanges of Nonmonetary Assets An Amendment
of APB Opinion No. 29, Accounting for Nonmonetary
Transactions (SFAS 153). SFAS 153
eliminates the exception from fair value measurement for
nonmonetary exchanges of similar productive assets in
paragraph 21(b) of APB Opinion No. 29,
Accounting for Nonmonetary Transactions, and
replaces it with an exception for exchanges that do not have
commercial substance. SFAS 153 specifies that a nonmonetary
exchange has commercial substance if the future cash flows of
the entity are expected to change significantly as a result of
the exchange. SFAS 153 is effective for the fiscal periods
beginning after June 15, 2005 and is required to be adopted
by IntraBiotics in the third quarter of 2005, beginning on
July 1, 2005. IntraBiotics is currently evaluating the
effect that the adoption of SFAS 153 will have on its
consolidated results of operations and financial condition but
does not expect it to have a material impact on its results of
operations or financial position.
The adoption of the following recent accounting pronouncements
did not have a material impact on IntraBiotics results of
operations and financial condition:
|
|
|
|
|
FASB issued revised SFAS No. 132(R) (revised 2003),
Employers Disclosures about Pensions and Other
Post-Retirement Benefits An Amendment of FASB
Statements No. 87, 88, and 106; and |
|
|
|
EITF Issue No. 03-1, The Meaning of
Other-Than-Temporary Impairment and Its Application to Certain
Investments. |
Factors That Could Affect Future Results
Our business faces significant risks and the risks described
below may not be the only risks we face. Additional risks that
we do not know of, or that we currently believe are immaterial,
may also impair our business operations. If any of the events or
circumstances described in the following risks actually occurs,
our business, financial condition, or results of operations
could be materially adversely affected.
|
|
|
We are currently a party to a securities litigation class
action lawsuit, which, if determined adversely, could negatively
affect or limit our strategic alternatives, our financial
results or business. |
We are currently a party to litigation that is described in
detail above in Part I, Item 3. Legal Proceedings
(Securities Litigation). The cost of defense and
ultimate disposition of the Securities Litigation could be
material. We will continue to incur expenses in defending the
Securities Litigation and, although we believe this litigation
is without merit, we may incur monetary losses in connection
with the final disposition of this litigation that may be
material. In addition, the litigation has been, and may continue
to be, time consuming and costly and could divert the attention
of our remaining management personnel.
|
|
|
Directors, executive officers, principal stockholders and
affiliated entities beneficially own or control at least 47% of
our capital stock and may be able to exert control over our
activities, and the results of our operations and financial
condition may suffer. |
As of December 31, 2004, our directors, executive officers,
principal stockholders and affiliated entities beneficially own
or control securities representing, in the aggregate, at least
47% of our outstanding common stock. These stockholders, if they
determine to vote in the same manner, may be able to control the
outcome of any matter requiring approval by our stockholders,
including the election of directors and the approval of mergers
or other business combination transactions or terms of any
liquidation.
14
|
|
|
The holders of our Series A preferred stock have
voting and other rights that they could exercise against your
best interests. |
The holders of our Series A preferred stock have rights to
designate two members of our Board and to vote as a separate
class on certain significant corporate transactions. The holders
of Series A preferred stock are entitled to receive
cumulative annual dividends of 8% of the original purchase price
of $10,000 per share, payable in common stock. In addition,
upon our liquidation or dissolution (including a merger or
acquisition), the holders of our Series A preferred stock
are entitled to receive a liquidation preference in an amount
equal to the greater of (i) $10,000 per share of
Series A preferred stock, or approximately
$3.25 million based on the 325 shares of Series A
preferred stock currently outstanding, plus any declared but
unpaid dividends or (ii) the amount that would have been
paid had each such share of Series A preferred stock been
converted to common stock. The holders of Series A
preferred stock also have a right of first refusal to purchase
their pro rata portion of any equity securities we propose to
offer to any person. Such right of first refusal is subject to
certain customary exclusions, including for shares issued
pursuant to any options or other stock awards granted to
employees, directors or consultants of IntraBiotics, equipment
leasing arrangements, debt financings, strategic financings and
public offerings that have been approved by the Board. The
holders of Series A preferred stock may exercise these
rights to the detriment of our common stockholders.
The holders of our Series A preferred stock also have the
right at any time to request that we register for resale the
shares of our common stock that they acquire upon conversion of
their Series A preferred stock or upon exercise of their
warrants to purchase our common stock, subject to certain
limitations. A registration statement has been filed with the
Securities and Exchange Commission and is currently effective
for the resale of the shares of common stock issuable upon
conversion of our Series A preferred stock and upon the
exercise of those warrants. In addition, the holders of our
Series A preferred stock may convert their Series A
preferred stock into common stock and sell those shares of the
common stock, acquired upon such conversion, in the public
market in reliance upon Rule 144, subject in some cases to
volume and other limitations. Future sales in the public market
of such common stock, or the perception that such sales might
occur, could adversely affect the prevailing market price of our
common stock.
|
|
|
Anti-takeover provisions in our charter documents and
under Delaware law may make it more difficult to acquire
us. |
Provisions of our certificate of incorporation and bylaws could
make it more difficult for a third party to acquire us, even if
doing so would be beneficial to our stockholders. These
provisions:
|
|
|
|
|
provide for a classified board of directors of which
approximately one-third of the directors will be elected each
year; |
|
|
|
allow the authorized number of directors to be changed only by
resolution of the Board; |
|
|
|
require that stockholder actions must be effected at a duly
called stockholder meeting and prohibit stockholder action by
written consent; |
|
|
|
establish advance notice requirements for nominations to the
Board or for proposals that can be acted on at stockholder
meetings; |
|
|
|
require the approval from the holders of Series A preferred
stock, prior to May 1, 2005, for i) any merger into or
consolidation with any other corporation, or ii) the completion
of any transaction, or series of related transactions, in which
fifty percent or more of our voting power is transferred, or
iii) the sale, lease or other disposition of all or
substantially all of our assets; |
|
|
|
authorize our Board to issue blank check preferred stock to
increase the amount of outstanding shares; and |
|
|
|
limit who may call stockholder meetings. |
In addition, because we are incorporated in Delaware, we are
governed by the provisions of Section 203 of the Delaware
General Corporation Law, which may prohibit large stockholders
from consummating a merger with, or acquisition of us. These
provisions may prevent a merger or acquisition that would be
attractive to
15
stockholders and could limit the price that investors would be
willing to pay in the future for our common stock.
|
|
|
Our stock price has been, and will be volatile, and the
value of your investment may continue to decline. |
During the year ended December 31, 2004, our closing stock
prices ranged from a low of $3.35 to a high of $19.25, and in
2003 ranged from a low of $1.54 to a high of $17.50.
Announcements regarding strategic alternatives, including a
merger or sale of the company, or acquisition or license of
products or product candidates, in addition to the other risk
factors described in this section, may have a significant impact
on the market price of our common stock.
|
|
|
We expect to continue to incur operating losses. |
Our accumulated deficit as of December 31, 2004 was
$232.2 million, and we expect operating losses to continue
at least through the end of 2005. During this period we intend
to incur final costs for the discontinuance of the clinical
trial of iseganan, evaluate our strategic
alternatives, including mergers, acquisitions,
in-licensing opportunities, or liquidation of the Company,
possibly pursue one of the alternatives, and defend the
Securities Litigation. We expect operating losses to continue
into future years, but we cannot predict the magnitude and
duration of such losses, since we are currently unable to
determine which strategic alternative we may elect to pursue or
whether we will be successful in achieving such alternative.
|
|
|
We may not be able to complete the strategic alternative
we initially elect to pursue, resulting in increased expenses
and a delay in finally completing a selected alternative. |
We may select a strategic alternative that we may not be able to
complete for various reasons, including a decision of our
principal stockholders not to approve such alternative, our
inability to obtain regulatory approval, actions of other
companies or litigation involving the selected alternative or
other matters. In addition, the pendency and or resolution of
the Securities Litigation may adversely affect or limit our
strategic alternatives, including adversely affecting our
financial results or our ability to liquidate, or deterring
other companies from entering into a merger or acquisition with
us.
|
|
|
We face risks associated with clinical trial liability
claims in the event that the prior use, or misuse, of our
product candidates in clinical trials, that have since been
terminated, results in personal injury or death. |
From the fourth quarter of 2002 until June 2004, we conducted
clinical trials focusing 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 face a risk of
clinical trial liability claims in the event that the prior use,
or misuse, of our product candidates during such clinical trials
results in personal injury or death. Our clinical liability
insurance coverage may not be sufficient to cover claims that
may be made against us. Any claims against us, regardless of
their merit, could severely harm our financial condition and
strain our management and other resources.
|
|
Item 7A. |
Quantitative and Qualitative Disclosure About Market
Risk |
The primary objective of our investment activities is to
preserve our capital until it is required to fund operations
while at the same time maximizing the income we receive from our
investments without significantly increasing risk. As of
December 31, 2004, we own financial instruments that are
sensitive to market risk as part of our investment portfolio. To
minimize this risk, in accordance with our investment policy
guidelines, we place investments with high credit quality
issuers (rated A1/P1 for short-term investments and Aa3/ AA- for
long-term investments) and limit the amount of credit exposure
to any one issuer to the greater of 5% of the investment
portfolio or $1 million, whichever is greater. There are no
concentration limits set for obligations of the government of
the United States of America and its federal agencies. The
average duration of our investment portfolio in 2004 and 2003
was less than one year and the maximum term allowed for any
investment was 15 months. Due to the short-term nature of
these investments,
16
a 50 basis point movement in market interest rates would
not have a material impact on the fair value of our portfolio as
of December 31, 2004 and 2003. We have no investments
denominated in foreign currencies and therefore our investments
are not subject to foreign currency exchange risk.
The following table summarizes the average interest rate and
estimated fair value of the short-term investments held by us as
of December 31, 2004 and 2003 (in thousands).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated | |
|
Average | |
|
|
Total | |
|
Fair | |
|
Interest | |
Short-Term Investments |
|
Cost | |
|
Value | |
|
Rate | |
|
|
| |
|
| |
|
| |
December 31, 2004
|
|
$ |
49,055 |
|
|
$ |
48,988 |
|
|
|
2.39 |
% |
December 31, 2003
|
|
$ |
12,106 |
|
|
$ |
12,108 |
|
|
|
1.36 |
% |
The following is a summary of the Companys
available-for-sale investments as of December 31, 2004 and
2003 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2004 | |
|
|
| |
|
|
|
|
Gross |
|
Gross | |
|
Estimated | |
|
|
Amortized | |
|
Unrealized |
|
Unrealized | |
|
Fair | |
|
|
Cost | |
|
Gains |
|
Losses | |
|
Value | |
|
|
| |
|
|
|
| |
|
| |
US government agencies
|
|
$ |
30,590 |
|
|
$ |
|
|
|
$ |
(67 |
) |
|
$ |
30,523 |
|
Auction rate securities
|
|
|
18,465 |
|
|
|
|
|
|
|
|
|
|
|
18,465 |
|
Money market funds
|
|
|
784 |
|
|
|
|
|
|
|
|
|
|
|
784 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale investments
|
|
$ |
49,839 |
|
|
$ |
|
|
|
$ |
(67 |
) |
|
|
49,772 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less amounts classified as cash equivalents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(784 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
48,988 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2003 | |
|
|
| |
|
|
|
|
Gross | |
|
Gross |
|
Estimated | |
|
|
Amortized | |
|
Unrealized | |
|
Unrealized |
|
Fair | |
|
|
Cost | |
|
Gains | |
|
Losses |
|
Value | |
|
|
| |
|
| |
|
|
|
| |
Money market funds
|
|
$ |
13,845 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
13,845 |
|
Auction rate securities
|
|
|
8,200 |
|
|
|
|
|
|
|
|
|
|
|
8,200 |
|
US government agencies
|
|
|
3,906 |
|
|
|
2 |
|
|
|
|
|
|
|
3,908 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale investments
|
|
$ |
25,951 |
|
|
$ |
2 |
|
|
$ |
|
|
|
|
25,953 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less amounts classified as cash equivalents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(13,845 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
12,108 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
None of the investments held as of December 31, 2004 or
2003 had been in a continuous unrealized loss position for more
than 12 months. The aggregate fair value of US government
agency investments held at December 31, 2004 which had
unrealized losses was $30,532,000. No investments held at
December 31, 2003 had unrealized losses. During 2004
interest rates generally rose and as a result all US government
agency investments held at December 31, 2004 are in an
unrealized loss position. The unrealized loss position will
continue until either the investment matures, or, until interest
rates drop below the rate in effect on the date the various
securities were purchased. As a result, the Company has
concluded that the impairment is temporary.
The following is a summary of amortized cost and estimated fair
value of available-for-sale investments by contract maturity (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2004 | |
|
December 31, 2003 | |
|
|
| |
|
| |
|
|
Amortized | |
|
Estimated | |
|
Amortized | |
|
Estimated | |
|
|
Cost | |
|
Fair Value | |
|
Cost | |
|
Fair Value | |
|
|
| |
|
| |
|
| |
|
| |
Due in less than one year
|
|
$ |
38,248 |
|
|
$ |
38,202 |
|
|
$ |
24,201 |
|
|
$ |
24,202 |
|
Due in one year or more
|
|
|
11,591 |
|
|
|
11,570 |
|
|
|
1,750 |
|
|
|
1,751 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
49,839 |
|
|
$ |
49,772 |
|
|
$ |
25,951 |
|
|
$ |
25,953 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17
|
|
Item 8. |
Financial Statements and Supplementary Data |
INTRABIOTICS PHARMACEUTICALS, INC.
INDEX TO FINANCIAL STATEMENTS
18
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
TO THE STOCKHOLDERS AND BOARD OF DIRECTORS OF
INTRABIOTICS PHARMACEUTICALS INC.:
We have audited the accompanying balance sheet of IntraBiotics
Pharmaceuticals Inc. as of December 31, 2004 and the
related statements of operations, stockholders equity and
cash flows for the year then ended. These financial statements
are the responsibility of the Companys management. Our
responsibility is to express an opinion on these financial
statements based on our audit.
We conducted our audit in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audit provides a
reasonable basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the financial position
of IntraBiotics Pharmaceuticals, Inc. as of December 31,
2004 and the results of its operations and its cash flows for
the year then ended in conformity with accounting principles
generally accepted in the United States of America.
|
|
|
/s/
Stonefield
Josephson, Inc.
|
|
Stonefield Josephson, Inc. |
San Francisco, California
February 11, 2005
19
REPORT OF ERNST & YOUNG, INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM
The Board of Directors and Stockholders of
IntraBiotics Pharmaceuticals, Inc.
We have audited the accompanying balance sheet of IntraBiotics
Pharmaceuticals, Inc. as of December 31, 2003 and the
related statements of operations, stockholders equity, and
cash flows for each of the two years in the period ended
December 31, 2003. These financial statements are the
responsibility of the Companys management. Our
responsibility is to express an opinion on these financial
statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the financial position
of IntraBiotics Pharmaceuticals, Inc. as of December 31,
2003, and the results of its operations and its cash flows for
each of the two years in the period ended December 31,
2003, in conformity with U.S. generally accepted accounting
principles.
Palo Alto, California
February 6, 2004
20
INTRABIOTICS PHARMACEUTICALS, INC.
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
|
(In thousands, except share | |
|
|
and per share amounts) | |
ASSETS |
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
1,755 |
|
|
$ |
14,286 |
|
|
Restricted cash
|
|
|
|
|
|
|
250 |
|
|
Short-term investments
|
|
|
48,988 |
|
|
|
12,108 |
|
|
Prepaid expenses and other current assets
|
|
|
396 |
|
|
|
478 |
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
51,139 |
|
|
|
27,122 |
|
Property and equipment, net
|
|
|
46 |
|
|
|
20 |
|
Other assets
|
|
|
|
|
|
|
184 |
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
51,185 |
|
|
$ |
27,326 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
154 |
|
|
$ |
141 |
|
|
Accrued clinical liabilities
|
|
|
161 |
|
|
|
1,046 |
|
|
Accrued employee liabilities
|
|
|
89 |
|
|
|
101 |
|
|
Other accrued liabilities
|
|
|
273 |
|
|
|
410 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
677 |
|
|
|
1,698 |
|
Commitments (Note 6)
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
|
Convertible preferred stock, $0.001 par value:
5,000,000 shares authorized; 325 shares outstanding
and $3,250 aggregate liquidation preference at December 31,
2004 and 2003
|
|
|
1,771 |
|
|
|
1,771 |
|
|
Common stock, $0.001 par value: 70,000,000 shares
authorized at December 31, 2004 and 2003; 8,880,344 and
5,298,206 shares outstanding at December 31, 2004 and
2003, respectively
|
|
|
9 |
|
|
|
5 |
|
|
Additional paid-in capital
|
|
|
281,068 |
|
|
|
239,237 |
|
|
Deferred stock compensation
|
|
|
(114 |
) |
|
|
(188 |
) |
|
Accumulated other comprehensive (loss) income
|
|
|
(67 |
) |
|
|
2 |
|
|
Accumulated deficit
|
|
|
(232,159 |
) |
|
|
(215,199 |
) |
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
50,508 |
|
|
|
25,628 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$ |
51,185 |
|
|
$ |
27,326 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial
statements.
21
INTRABIOTICS PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands, except per share | |
|
|
amounts) | |
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$ |
11,519 |
|
|
$ |
7,727 |
|
|
$ |
23,053 |
|
|
General and administrative
|
|
|
4,819 |
|
|
|
5,782 |
|
|
|
8,617 |
|
|
Restructuring and other charges
|
|
|
858 |
|
|
|
|
|
|
|
6,118 |
|
|
Arbitration settlement
|
|
|
|
|
|
|
|
|
|
|
(3,600 |
) |
|
Impairment of acquired workforce
|
|
|
|
|
|
|
|
|
|
|
1,365 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
17,196 |
|
|
|
13,509 |
|
|
|
35,553 |
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(17,196 |
) |
|
|
(13,509 |
) |
|
|
(35,553 |
) |
|
Interest income
|
|
|
700 |
|
|
|
166 |
|
|
|
703 |
|
|
Interest expense
|
|
|
|
|
|
|
|
|
|
|
(459 |
) |
|
Other income/(expense), net
|
|
|
(204 |
) |
|
|
31 |
|
|
|
856 |
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(16,700 |
) |
|
|
(13,312 |
) |
|
|
(34,453 |
) |
Non-cash deemed dividend related to beneficial conversion
feature of Series A preferred stock
|
|
|
|
|
|
|
(1,436 |
) |
|
|
|
|
Non-cash dividends on Series A preferred stock
|
|
|
(260 |
) |
|
|
(182 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stockholders
|
|
$ |
(16,960 |
) |
|
$ |
(14,930 |
) |
|
$ |
(34,453 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share applicable to common
stockholders
|
|
$ |
(2.24 |
) |
|
$ |
(4.01 |
) |
|
$ |
(11.25 |
) |
|
|
|
|
|
|
|
|
|
|
Shares used to compute basic and diluted net loss per share
applicable to common stockholders
|
|
|
7,559 |
|
|
|
3,720 |
|
|
|
3,064 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial
statements.
22
INTRABIOTICS PHARMACEUTICALS, INC.
STATEMENTS OF STOCKHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible | |
|
|
|
|
|
|
|
Accumulated | |
|
|
|
|
|
|
Preferred Stock | |
|
Common Stock | |
|
Additional | |
|
Deferred | |
|
Other | |
|
|
|
Total | |
|
|
| |
|
| |
|
Paid-In | |
|
Stock | |
|
Comprehensive | |
|
Accumulated | |
|
Stockholders | |
|
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Capital | |
|
Compensation | |
|
Income (Loss) | |
|
Deficit | |
|
Equity | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Balances at December 31, 2001
|
|
|
|
|
|
$ |
|
|
|
|
2,483 |
|
|
$ |
2 |
|
|
$ |
196,603 |
|
|
$ |
(4,577 |
) |
|
$ |
|
|
|
$ |
(165,816 |
) |
|
$ |
26,212 |
|
Issuance of common stock upon exercise of options for cash
|
|
|
|
|
|
|
|
|
|
|
29 |
|
|
|
|
|
|
|
471 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
471 |
|
Issuance of common stock on private placement for cash
|
|
|
|
|
|
|
|
|
|
|
596 |
|
|
|
1 |
|
|
|
18,980 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,981 |
|
Issuance of common stock on acquisition of Apothogen Inc.
|
|
|
|
|
|
|
|
|
|
|
37 |
|
|
|
|
|
|
|
1,924 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,924 |
|
Stock compensation for consultant services
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
512 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
512 |
|
Issuance of common stock for the employee stock purchase plan
for cash
|
|
|
|
|
|
|
|
|
|
|
1 |
|
|
|
|
|
|
|
10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10 |
|
Issuance of warrants to purchase 4 shares of common stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7 |
|
Issuance of of common stock for services
|
|
|
|
|
|
|
|
|
|
|
123 |
|
|
|
|
|
|
|
545 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
545 |
|
Amortization of deferred stock compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,271 |
|
|
|
|
|
|
|
|
|
|
|
1,271 |
|
Cancellation of stock options related to employee terminations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,586 |
) |
|
|
2,586 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(34,453 |
) |
|
|
(34,453 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at December 31, 2002
|
|
|
|
|
|
|
|
|
|
|
3,269 |
|
|
|
3 |
|
|
|
216,466 |
|
|
|
(720 |
) |
|
|
|
|
|
|
(200,269 |
) |
|
|
15,480 |
|
Issuance of common stock upon exercise of options for cash
|
|
|
|
|
|
|
|
|
|
|
50 |
|
|
|
|
|
|
|
380 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
380 |
|
Issuance of common stock and warrants on private placement, net
of $710 issuance costs
|
|
|
|
|
|
|
|
|
|
|
1,774 |
|
|
|
2 |
|
|
|
18,536 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,538 |
|
Issuance of Series A preferred stock and common stock
warrants on private placement, net of $268 issuance costs
|
|
|
|
|
|
|
1,906 |
|
|
|
|
|
|
|
|
|
|
|
1,326 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,232 |
|
Beneficial conversion feature on Series A preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,436 |
|
|
|
|
|
|
|
|
|
|
|
(1,436 |
) |
|
|
|
|
Issuance of common stock upon conversion of Series A
preferred stock
|
|
|
|
|
|
|
(135 |
) |
|
|
132 |
|
|
|
|
|
|
|
135 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock as dividend on series A preferred
stock
|
|
|
|
|
|
|
|
|
|
|
18 |
|
|
|
|
|
|
|
117 |
|
|
|
|
|
|
|
|
|
|
|
(182 |
) |
|
|
(65 |
) |
Issuance of common stock upon exercise of warrants
|
|
|
|
|
|
|
|
|
|
|
55 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred stock compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
126 |
|
|
|
|
|
|
|
|
|
|
|
126 |
|
Stock compensation for variable option awards
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
993 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
993 |
|
Stock compensation for consultant services
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
254 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
254 |
|
Cancellation of stock options related to employee terminations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(406 |
) |
|
|
406 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(13,312 |
) |
|
|
(13,312 |
) |
|
Unrealized gain on securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(13,310 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23
INTRABIOTICS PHARMACEUTICALS, INC.
STATEMENTS OF STOCKHOLDERS
EQUITY (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible | |
|
|
|
|
|
|
|
Accumulated | |
|
|
|
|
|
|
Preferred Stock | |
|
Common Stock | |
|
Additional | |
|
Deferred | |
|
Other | |
|
|
|
Total | |
|
|
| |
|
| |
|
Paid-In | |
|
Stock | |
|
Comprehensive | |
|
Accumulated | |
|
Stockholders | |
|
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Capital | |
|
Compensation | |
|
Income (Loss) | |
|
Deficit | |
|
Equity | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Balances at December 31, 2003
|
|
|
|
|
|
|
1,771 |
|
|
|
5,298 |
|
|
|
5 |
|
|
|
239,237 |
|
|
|
(188 |
) |
|
|
2 |
|
|
|
(215,199 |
) |
|
|
25,628 |
|
Issuance of common stock upon exercise of options for cash
|
|
|
|
|
|
|
|
|
|
|
87 |
|
|
|
1 |
|
|
|
241 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
242 |
|
Issuance of common stock in a public offering, net of $3,337
issuance costs
|
|
|
|
|
|
|
|
|
|
|
3,450 |
|
|
|
3 |
|
|
|
41,509 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
41,512 |
|
Issuance of common stock as dividend on series A preferred
stock
|
|
|
|
|
|
|
|
|
|
|
41 |
|
|
|
|
|
|
|
260 |
|
|
|
|
|
|
|
|
|
|
|
(260 |
) |
|
|
|
|
Issuance of common stock upon exercise of warrants
|
|
|
|
|
|
|
|
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred stock compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
61 |
|
|
|
|
|
|
|
|
|
|
|
61 |
|
Stock compensation for variable option awards
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(638 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(638 |
) |
Stock compensation for consultant services
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
472 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
472 |
|
Cancellation of stock options related to employee terminations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(13 |
) |
|
|
13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,700 |
) |
|
|
(16,700 |
) |
|
Unrealized loss on securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(69 |
) |
|
|
|
|
|
|
(69 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,769 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at December 31, 2004
|
|
|
|
|
|
$ |
1,771 |
|
|
|
8,880 |
|
|
$ |
9 |
|
|
$ |
281,068 |
|
|
$ |
(114 |
) |
|
$ |
(67 |
) |
|
$ |
(232,159 |
) |
|
$ |
50,508 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial
statements.
24
INTRABIOTICS PHARMACEUTICALS, INC.
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(16,700 |
) |
|
$ |
(13,312 |
) |
|
$ |
(34,453 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock compensation for variable option awards
|
|
|
(638 |
) |
|
|
993 |
|
|
|
|
|
|
Amortization of deferred stock compensation
|
|
|
61 |
|
|
|
126 |
|
|
|
1,271 |
|
|
Stock compensation for consultant services
|
|
|
472 |
|
|
|
254 |
|
|
|
512 |
|
|
Stock compensation for services
|
|
|
|
|
|
|
|
|
|
|
545 |
|
|
Depreciation and amortization
|
|
|
35 |
|
|
|
92 |
|
|
|
725 |
|
|
Write down of property and equipment
|
|
|
33 |
|
|
|
|
|
|
|
274 |
|
|
Acquired workforce write down and amortization
|
|
|
|
|
|
|
|
|
|
|
1,694 |
|
|
Gain on sale of pre-clinical programs
|
|
|
|
|
|
|
|
|
|
|
(975 |
) |
|
Fair value of warrants issued
|
|
|
|
|
|
|
|
|
|
|
7 |
|
|
Change in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted cash
|
|
|
250 |
|
|
|
|
|
|
|
7,238 |
|
|
|
Prepaid expenses and other current assets
|
|
|
82 |
|
|
|
2,144 |
|
|
|
3,087 |
|
|
|
Other assets
|
|
|
184 |
|
|
|
(7 |
) |
|
|
41 |
|
|
|
Accounts payable
|
|
|
13 |
|
|
|
(204 |
) |
|
|
(245 |
) |
|
|
Accrued clinical liabilities
|
|
|
(885 |
) |
|
|
1,046 |
|
|
|
(1,663 |
) |
|
|
Accrued employee liabilities
|
|
|
(12 |
) |
|
|
(34 |
) |
|
|
(475 |
) |
|
|
Accrued restructuring charges
|
|
|
5 |
|
|
|
(64 |
) |
|
|
(2,797 |
) |
|
|
Deferred rent
|
|
|
|
|
|
|
|
|
|
|
(618 |
) |
|
|
Other accrued liabilities
|
|
|
(142 |
) |
|
|
143 |
|
|
|
(515 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(17,242 |
) |
|
|
(8,823 |
) |
|
|
(26,347 |
) |
Investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures
|
|
|
(94 |
) |
|
|
|
|
|
|
(41 |
) |
|
Proceeds from sale of property and equipment
|
|
|
|
|
|
|
|
|
|
|
526 |
|
|
Proceeds from sale of pre-clinical programs
|
|
|
|
|
|
|
|
|
|
|
800 |
|
|
Purchase of short term investments
|
|
|
(65,167 |
) |
|
|
(12,106 |
) |
|
|
(2,895 |
) |
|
Proceeds from sale or maturity of short-term investments
|
|
|
28,218 |
|
|
|
2,895 |
|
|
|
|
|
|
Cash received in acquisition of subsidiary
|
|
|
|
|
|
|
|
|
|
|
58 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(37,043 |
) |
|
|
(9,211 |
) |
|
|
(1,552 |
) |
Financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of Series A preferred stock in
private placement, net
|
|
|
|
|
|
|
3,232 |
|
|
|
|
|
|
Proceeds from issuance of common stock in private placements, net
|
|
|
|
|
|
|
18,538 |
|
|
|
18,981 |
|
|
Proceeds from issuance of common stock in a public offering, net
|
|
|
41,512 |
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock upon exercise of options
|
|
|
242 |
|
|
|
380 |
|
|
|
481 |
|
|
Payments on financing obligations
|
|
|
|
|
|
|
|
|
|
|
(9,375 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
41,754 |
|
|
|
22,150 |
|
|
|
10,087 |
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
(12,531 |
) |
|
|
4,116 |
|
|
|
(17,812 |
) |
Cash and cash equivalents at beginning of the year
|
|
|
14,286 |
|
|
|
10,170 |
|
|
|
27,982 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of the year
|
|
$ |
1,755 |
|
|
$ |
14,286 |
|
|
$ |
10,170 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid
|
|
$ |
|
|
|
$ |
|
|
|
$ |
459 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net deferred stock compensation (cancellations due to employee
termination)
|
|
$ |
(13 |
) |
|
$ |
(406 |
) |
|
$ |
(2,586 |
) |
|
|
|
|
|
|
|
|
|
|
|
Beneficial conversion feature on Series A preferred stock
|
|
$ |
|
|
|
$ |
(1,436 |
) |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock dividend on Series A preferred
stock
|
|
$ |
(260 |
) |
|
$ |
(182 |
) |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock upon conversion of Series A
preferred stock
|
|
$ |
|
|
|
$ |
(135 |
) |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other assets received from sale of pre-clinical programs
|
|
$ |
|
|
|
$ |
|
|
|
$ |
375 |
|
|
|
|
|
|
|
|
|
|
|
Cash flow for acquisition of subsidiary:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired workforce
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1,694 |
|
|
Other current assets acquired
|
|
|
|
|
|
|
|
|
|
|
297 |
|
|
Property and equipment acquired
|
|
|
|
|
|
|
|
|
|
|
56 |
|
|
Liabilities assumed
|
|
|
|
|
|
|
|
|
|
|
(75 |
) |
|
Acquisition costs incurred
|
|
|
|
|
|
|
|
|
|
|
(106 |
) |
|
Common stock issued
|
|
|
|
|
|
|
|
|
|
|
(1,924 |
) |
|
|
|
|
|
|
|
|
|
|
|
Cash received in acquisition
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(58 |
) |
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial
statements.
25
NOTES TO FINANCIAL STATEMENTS
|
|
1. |
Description of Business |
IntraBiotics Pharmaceuticals, Inc. (IntraBiotics or
the Company), was incorporated in the state of
Delaware in 1994. 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 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.
|
|
2. |
Summary of Significant Accounting Policies and Concentrations
of Risk |
The preparation of financial statements in conformity with
generally accepted accounting principles requires management to
make estimates and assumptions that affect the amounts reported
in the financial statements and accompanying notes, including
amounts accrued for clinical trial costs and stock-based
compensation.
The Companys estimate of accrued costs is 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.
|
|
|
Concentrations of Credit Risk and Fair Value of Financial
Instruments |
Financial instruments, which subject the Company to
concentrations of credit risk, consist primarily of investments
in certain debt securities and accounts receivable. The Company
invests its cash equivalents and short-term investments in high
credit quality investments, in accordance with its investment
policy, and limits its exposure to certain issuers, which
minimizes the possibility of a loss. The Company does not
require collateral on cash equivalents and short-term
investments. The Company is exposed to credit risks in the event
of default by the financial institutions or issuers of
investments to the extent recorded on the balance sheet.
The fair value of financial instruments, including cash, cash
equivalents, short-term investments, accounts payable and
accrued liabilities approximate their carrying value.
|
|
|
Cash Equivalents and Short-Term Investments |
Cash equivalents are comprised of money market funds and debt
securities with original maturities of less than 90 days.
Short-term investments include securities with maturities of
less than one year from the balance sheet date, or securities
with maturities of greater than one year that are specifically
identified to fund current operations. All cash equivalents and
short-term investments are classified as available-for-sale. The
Companys investment securities are recorded at their fair
market value, based on quoted market prices. The cost of
securities when sold is based upon the specific identification
method. Any unrealized gains and losses are recorded as other
comprehensive income and included as a separate component of
stockholders equity. Realized gains and losses and
declines in value judged to be other than temporary on
available-for-sale investments are included in other income, net
in the statements of operations. Gains and losses on sales of
available-for-sale investments have been immaterial.
26
NOTES TO FINANCIAL STATEMENTS (Continued)
Property and equipment are stated at cost less accumulated
depreciation, which is calculated using the straight-line method
over the estimated useful lives of the respective assets,
generally being three to five years. Leasehold improvements are
depreciated over the terms of the facilities leases.
|
|
|
Impairment of Long-Lived Assets |
Long-lived assets and certain identifiable intangible assets to
be held and used are reviewed for impairment when events or
changes in circumstances indicate that the carrying amount of
such assets may not be recoverable. Determination of
recoverability is generally based on an estimate of undiscounted
cash flows resulting from the use of the assets and their
eventual disposition. In the event that such cash flows are
insufficient to recover the carrying amount of the assets, the
assets are written down to the estimated fair value. Long-lived
assets to be disposed of are reported at the lower of the
carrying amount or the estimated fair value less costs to sell.
Research and development expenditures are charged to operations
as incurred, and include fees paid to contract research
organizations and other clinical service providers, payroll
expense, drug substance expense, allocated facilities costs and
non-cash stock compensation charges.
The Company has undertaken a number of restructuring efforts. Up
until the restructuring efforts undertaken in 2004 the Company
accounted for restructuring charges in accordance with the
provisions of Emerging Issues Task Force 94-3 Liability
Recognition for Certain Employee Termination Benefits and Other
Costs to Exit an Activity (including Certain Costs Incurred in a
Restructuring) and related interpretations. During 2004
the Company accounted for restructuring charges in accordance
with Statement of Accounting Standards No. 146,
Accounting for Costs Associated with Exit of Disposal of
Activities. See Note 8 Restructuring and
Other Charges for additional disclosures.
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 quarter. 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. In June
2004, we discontinued our clinical trial of iseganan for the
prevention of VAP. As of December 31, 2004 clinical trials
accruals of $161,000 consisted of amounts due to hospitals and
doctors who participated in this trial.
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
27
NOTES TO FINANCIAL STATEMENTS (Continued)
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 stock options issued to employees 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 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.
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
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.
See Note 10 Employee Benefit Plans
Stock Compensation for details of stock compensation expense.
The following table illustrates the effect on net loss and net
loss per share applicable to common stockholders if the Company
had applied the fair value recognition provisions of
SFAS 123 to stock-based employee compensation. For purposes
of this pro-forma disclosure, the value of the options is
estimated using a Black-Scholes option pricing model and
amortized ratably to expense over the options vesting
periods.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands, except per share | |
|
|
amounts) | |
Net loss applicable to common stockholders, as reported
|
|
$ |
(16,960 |
) |
|
$ |
(14,930 |
) |
|
$ |
(34,453 |
) |
Add: Stock-based employee compensation expense
(recovery) included in reported net loss applicable to
common stockholders
|
|
|
(577 |
) |
|
|
1,119 |
|
|
|
1,271 |
|
Deduct: Total stock-based employee compensation expense
determined under fair value based method for all awards
|
|
|
(7,049 |
) |
|
|
(1,577 |
) |
|
|
(6,084 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stockholders, pro forma
|
|
$ |
(24,586 |
) |
|
$ |
(15,388 |
) |
|
$ |
(39,266 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per share applicable to common stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted as reported
|
|
$ |
(2.24 |
) |
|
$ |
(4.01 |
) |
|
$ |
(11.25 |
) |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted pro forma
|
|
$ |
(3.25 |
) |
|
$ |
(4.14 |
) |
|
$ |
(12.82 |
) |
|
|
|
|
|
|
|
|
|
|
28
NOTES TO FINANCIAL STATEMENTS (Continued)
The fair value of stock options granted to employees was
estimated at the date of the grant using the Black-Scholes
option pricing model with the following weighted-average
assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Risk-free interest rate
|
|
|
3.55 |
% |
|
|
2.92 |
% |
|
|
2.89 |
% |
Volatility
|
|
|
1.00 |
|
|
|
1.00 |
|
|
|
1.00 |
|
Dividend yield
|
|
|
0.00 |
% |
|
|
0.00 |
% |
|
|
0.00 |
% |
Expected life of option
|
|
|
5 years |
|
|
|
5 years |
|
|
|
5 years |
|
The weighted-average fair value of options granted to employees
during 2004, 2003, and 2002 was $11.43, $2.24 and $25.92,
respectively.
The fair value of the employees purchase rights under the
Companys Employee Stock Purchase Plan, which was suspended
in March 2003 (see Note 10 Employee Benefit
Plans 2000 Employee Stock Purchase Plan), was
estimated using the Black-Scholes option pricing model with the
above weighted average assumptions for volatility and dividend
yield, expected lives of 6 months, and a risk free interest
rate of 1.26% in 2002. The weighted-average fair value of rights
issued under the Purchase Plan for 2002 was $5.40.
The components of comprehensive loss in each year presented are
as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Net loss
|
|
$ |
(16,700 |
) |
|
$ |
(13,312 |
) |
|
$ |
(34,453 |
) |
Unrealized gain (loss) on available-for-sale securities
|
|
|
(69 |
) |
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
$ |
(16,769 |
) |
|
$ |
(13,310 |
) |
|
$ |
(34,453 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share applicable to common
stockholders is presented in accordance with Financial
Accounting Standards Board Statement No. 128,
Earnings Per Share, and is calculated using
the weighted-average number of shares of common stock
outstanding during the period. Diluted net loss per share
applicable to common stockholders includes the impact of
potentially dilutive securities (stock options, warrants and
convertible preferred stock). As the Companys potentially
dilutive securities were anti-dilutive for all periods
presented, they are not included in the calculations of diluted
net loss per share applicable to common stockholders. The total
number of shares underlying the stock options, warrants and
convertible preferred stock excluded from the calculations of
net loss per share applicable to common stockholders was
4,133,843, 3,297,363 and 693,845 for the years ended
December 31, 2004, 2003 and 2002, respectively.
Disclosure of certain amounts included in the Statements of Cash
Flows for 2003 and 2002 and described as Stock
compensation expense in prior year financial statements,
has been expanded and are now included under the descriptions
Stock compensation for variable option awards,
Amortization of deferred stock compensation,
Stock compensation for consultant services and
Stock compensation for services. Reclassifications
related to cash proceeds from option exercises in 2002 have been
made in the Statement of Cash Flows to conform to current year
classifications.
29
NOTES TO FINANCIAL STATEMENTS (Continued)
|
|
|
Recent Accounting Pronouncements |
In December 2004, the FASB issued SFAS No. 123
(revised 2004), Share-Based Payment
(SFAS 123R), which replaces
SFAS No. 123, Accounting for Stock-Based
Compensation (SFAS 123) and supercedes
APB Opinion No. 25, Accounting for Stock Issued to
Employees. SFAS 123R requires all share-based
payments to employees, including grants of employee stock
options, to be recognized in the financial statements based on
their fair values, beginning with the first interim or annual
period after June 15, 2005, with early adoption encouraged.
The pro forma disclosures previously permitted under
SFAS 123, no longer will be an alternative to financial
statement recognition. We are required to adopt SFAS 123R
in our third quarter of fiscal 2005, beginning July 1,
2005. Under SFAS 123R, we must determine the appropriate
fair value model to be used for valuing share-based payments,
the amortization method for compensation cost and the transition
method to be used at date of adoption. The transition methods
include prospective and retroactive adoption options. Under the
retroactive options, prior periods may be restated either as of
the beginning of the year of adoption or for all periods
presented. The prospective method requires that compensation
expense be recorded for all unvested stock options and
restricted stock at the beginning of the first quarter of
adoption of SFAS 123R, while the retroactive methods would
record compensation expense for all unvested stock options and
restricted stock beginning with the first period restated. We
are evaluating the requirements of SFAS 123R and we expect
that the adoption of SFAS 123R will have a material impact
on our consolidated results of operations and earnings per
share. We have not yet determined the method of adoption or the
effect of adopting SFAS 123R, and we have not determined
whether the adoption will result in amounts that are similar to
the current pro forma disclosures under SFAS 123 shown in
Note 10 Employee Benefit Plans
Stock Compensation.
In December 2004, the FASB issued SFAS No. 153,
Exchanges of Nonmonetary Assets An Amendment
of APB Opinion No. 29, Accounting for Nonmonetary
Transactions (SFAS 153). SFAS 153
eliminates the exception from fair value measurement for
nonmonetary exchanges of similar productive assets in
paragraph 21(b) of APB Opinion No. 29,
Accounting for Nonmonetary Transactions, and
replaces it with an exception for exchanges that do not have
commercial substance. SFAS 153 specifies that a nonmonetary
exchange has commercial substance if the future cash flows of
the entity are expected to change significantly as a result of
the exchange. SFAS 153 is effective for the fiscal periods
beginning after June 15, 2005 and is required to be adopted
by IntraBiotics in the third quarter of 2005, beginning on
July 1, 2005. IntraBiotics is currently evaluating the
effect that the adoption of SFAS 153 will have on its
consolidated results of operations and financial condition but
does not expect it to have a material impact on its results of
operations or financial position.
The adoption of the following recent accounting pronouncements
did not have a material impact on IntraBiotics results of
operations and financial condition:
|
|
|
|
|
FASB issued revised SFAS No. 132(R) (revised 2003),
Employers Disclosures about Pensions and Other
Post-Retirement Benefits An Amendment of FASB
Statements No. 87, 88, and 106; and |
|
|
|
EITF Issue No. 03-1, The Meaning of
Other-Than-Temporary Impairment and Its Application to Certain
Investments. |
30
NOTES TO FINANCIAL STATEMENTS (Continued)
|
|
3. |
Available-For-Sale Investments |
The following is a summary of the Companys
available-for-sale investments as of December 31, 2004 and
2003 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2004 | |
|
|
| |
|
|
|
|
Gross |
|
Gross | |
|
|
|
|
Amortized | |
|
Unrealized |
|
Unrealized | |
|
Estimated | |
|
|
Cost | |
|
Gains |
|
Losses | |
|
Fair Value | |
|
|
| |
|
|
|
| |
|
| |
US government agencies
|
|
$ |
30,590 |
|
|
$ |
|
|
|
$ |
(67 |
) |
|
$ |
30,523 |
|
Auction rate securities
|
|
|
18,465 |
|
|
|
|
|
|
|
|
|
|
|
18,465 |
|
Money market funds
|
|
|
784 |
|
|
|
|
|
|
|
|
|
|
|
784 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale investments
|
|
$ |
49,839 |
|
|
$ |
|
|
|
$ |
(67 |
) |
|
|
49,772 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less amounts classified as cash equivalents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(784 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
48,988 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2003 | |
|
|
| |
|
|
|
|
Gross | |
|
Gross |
|
|
|
|
Amortized | |
|
Unrealized | |
|
Unrealized |
|
Estimated | |
|
|
Cost | |
|
Gains | |
|
Losses |
|
Fair Value | |
|
|
| |
|
| |
|
|
|
| |
Money market funds
|
|
$ |
13,845 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
13,845 |
|
Auction rate securities
|
|
|
8,200 |
|
|
|
|
|
|
|
|
|
|
|
8,200 |
|
US government agencies
|
|
|
3,906 |
|
|
|
2 |
|
|
|
|
|
|
|
3,908 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale investments
|
|
$ |
25,951 |
|
|
$ |
2 |
|
|
$ |
|
|
|
|
25,953 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less amounts classified as cash equivalents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(13,845 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
12,108 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
None of the investments held as of December 31, 2004 or
2003 had been in a continuous unrealized loss position for more
than 12 months. The aggregate fair value of US government
agency investments held at December 31, 2004 which had
unrealized losses was $30,532,000. No investments held at
December 31, 2003 had unrealized losses. During 2004
interest rates generally rose and as a result all US government
agency investments held at December 31, 2004 are in an
unrealized loss position. The unrealized loss position will
continue until either the investment matures, or, until interest
rates drop below the rate in effect on the date the various
securities were purchased. As a result the Company has concluded
that the impairment is temporary.
The following is a summary of amortized cost and estimated fair
value of available-for-sale investments by contract maturity (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2004 | |
|
December 31, 2003 | |
|
|
| |
|
| |
|
|
Amortized | |
|
Estimated | |
|
Amortized | |
|
Estimated | |
|
|
Cost | |
|
Fair Value | |
|
Cost | |
|
Fair Value | |
|
|
| |
|
| |
|
| |
|
| |
Due in less than one year
|
|
$ |
38,248 |
|
|
$ |
38,202 |
|
|
$ |
24,201 |
|
|
$ |
24,202 |
|
Due in one year or more
|
|
|
11,591 |
|
|
|
11,570 |
|
|
|
1,750 |
|
|
|
1,751 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
49,839 |
|
|
$ |
49,772 |
|
|
$ |
25,951 |
|
|
$ |
25,953 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31
NOTES TO FINANCIAL STATEMENTS (Continued)
|
|
4. |
Property and Equipment |
Property and equipment consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Machinery and equipment
|
|
$ |
373 |
|
|
$ |
328 |
|
Less accumulated depreciation
|
|
|
(327 |
) |
|
|
(308 |
) |
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
$ |
46 |
|
|
$ |
20 |
|
|
|
|
|
|
|
|
Depreciation and amortization expense for property and equipment
totaled $35,000, $92,000 and $725,000 for the years ended
December 31, 2004, 2003 and 2002, respectively.
|
|
5. |
Other Accrued Liabilities |
Other accrued liabilities consist of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Accrued professional fees
|
|
$ |
144 |
|
|
$ |
300 |
|
Accrued dividends on Series A convertible preferred stock
|
|
|
65 |
|
|
|
65 |
|
Other accrued liabilities
|
|
|
64 |
|
|
|
45 |
|
|
|
|
|
|
|
|
|
Total other accrued liabilities
|
|
$ |
273 |
|
|
$ |
410 |
|
|
|
|
|
|
|
|
The Company occupies office space in Palo Alto, California under
the terms of a lease, which terminates at the end of June 2005.
The Company has the option to extend the lease term until
December 31, 2005 at the then market rate. Under the terms
of this lease and other operating leases the company is
obligated to pay rent of approximately $66,000 and $1,000, in
2005 and 2006, respectively.
Total rent expense for the years ended December 31, 2004,
2003, and 2002 was approximately $261,000, $93,000, and
$3.0 million. Of the $261,000 rent expense in 2004,
$83,000 was included in restructuring and other charges. Of the
$3.0 million rent expense in 2002, $2.5 million was
included in restructuring and other charges.
In addition to the contractual commitments listed above we have
various severance plans that cover all of our employees. In
accordance with these plans we may be obligated to make various
severance payments and pay for certain health costs if our
existing employees should be terminated. These commitments
totaled $1.1 million as of December 31, 2004.
|
|
7. |
Restructuring and Other Charges |
In May 2001, the Company implemented a restructuring plan
intended to conserve capital and focus resources on the
development of iseganan as part of which it recorded various
charges during 2001. At December 31, 2001, the Company
accrued $2.9 million related to facilities consolidation.
In November 2002, the Company reached agreements with the
landlords of one of its previous facilities, which the Company
had subleased, to terminate the leases. During 2002, the Company
recorded an additional expense of $5.2 million and the
revised total liability was satisfied by cash payments, the
issuance of common stock and the write-off of a deferred rent
balance. At December 31, 2002 there were no accrued
restructuring charges related to these facilities.
32
NOTES TO FINANCIAL STATEMENTS (Continued)
The May 2001 restructuring consisted of the following activity
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Terminated | |
|
|
|
|
Costs for | |
|
|
|
Collaboration | |
|
|
|
|
Terminated | |
|
Facilities | |
|
Agreements | |
|
|
|
|
Employees | |
|
Consolidation | |
|
and Other | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
2001 Activity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Original restructuring charges
|
|
$ |
2,911 |
|
|
$ |
3,150 |
|
|
$ |
4,060 |
|
|
$ |
10,121 |
|
Cash refund (payments)
|
|
|
(2,675 |
) |
|
|
(2,219 |
) |
|
|
(3,983 |
) |
|
|
(8,877 |
) |
Non-cash expenses issuance of warrants
|
|
|
|
|
|
|
|
|
|
|
(560 |
) |
|
|
(560 |
) |
Adjustment to reflect revised estimates
|
|
|
(236 |
) |
|
|
1,930 |
|
|
|
483 |
|
|
|
2,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued restructuring charges at December 31, 2001
|
|
|
|
|
|
|
2,861 |
|
|
|
|
|
|
|
2,861 |
|
2002 Activity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash refund (payments)
|
|
|
75 |
|
|
|
(8,464 |
) |
|
|
(166 |
) |
|
|
(8,555 |
) |
Non-cash expenses issuance of common stock
|
|
|
|
|
|
|
(437 |
) |
|
|
|
|
|
|
(437 |
) |
Reclass deferred rent liability
|
|
|
|
|
|
|
861 |
|
|
|
|
|
|
|
861 |
|
Adjustment to reflect revised estimates
|
|
|
(75 |
) |
|
|
5,179 |
|
|
|
166 |
|
|
|
5,270 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued restructuring charges at December 31, 2002
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In October 2002, the Company announced a restructuring plan as a
result of the failure of its then recently completed
phase III clinical trial of iseganan for the prevention of
oral mucositis in cancer patients. This restructuring plan
reduced headcount by 26 employees in research and development
and general and administration, or 70% of the Companys
workforce. The Company recorded restructuring charges of
$848,000 for severance costs of which $784,000 were paid as of
December 31, 2002. The remaining severance accrual as of
December 31, 2002 of $64,000 was paid in January 2003 to
employees who left the Company in December 2002. No other
amounts were expensed in 2003 as a result of this restructuring
plan.
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 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.
33
NOTES TO FINANCIAL STATEMENTS (Continued)
In April 2002, the Company acquired Apothogen, Inc., a privately
held pharmaceutical in-licensing company based in North
Carolina. The Company issued 37,500 shares of its common
stock in exchange for all of Apothogens outstanding
capital stock. The total purchase price of $2.0 million was
determined based on the average closing price of the
Companys stock on the two days prior to the closing date,
the closing date and two days after the closing date.
The Company allocated the purchase price based on the relative
fair value of the net tangible and intangible assets acquired.
Net tangible assets were valued at $300,000 and consisted
primarily of cash, other current assets and fixed assets. The
amount of the purchase price in excess of the net tangible
assets acquired of $1.7 million was allocated to acquired
workforce, which was to be amortized over three years. The
acquired workforce, net of amortization, of $1.4 million
was deemed to be impaired after the failed results of the
phase III trial of iseganan for the prevention of oral
mucositis. The acquired workforce was comprised of sales and
marketing management, and given there would be no drug approval
in the near future, the acquired workforce was deemed impaired,
and therefore written down to zero in December 2002.
The Company acquired Apothogen in order to obtain its workforce,
primarily sales and marketing management and to obtain the
services of Ernest Mario Ph.D. Concurrent with the closing of
the acquisition, Dr. Mario, joined the Company as Chairman
and Chief Executive Officer and purchased $5.0 million of
newly issued shares of the Companys common stock in a
private placement at a purchase price of $48.12 per share.
Dr. Mario is currently Chairman of the Companys Board
of Directors.
The Company is authorized to issue 5,000,000 shares of
preferred stock, of $0.001 par value. On May 1, 2003,
in a private placement transaction, the Company sold
350 shares of a newly created Series A convertible
preferred stock (the Preferred Stock),
$0.001 par value, and issued warrants to
purchase 920,699 shares of the Companys common
stock, resulting in net cash proceeds of $3.2 million. The
primary purpose of completing the private placement was to
provide funds for a clinical trial of iseganan for the
prevention of VAP, as well as for other general corporate
purposes and working capital.
The Preferred Stock is convertible into 1,841,404 shares of
common stock at any time, at a conversion price of
$1.90 per share, subject to adjustment upon the occurrence
of certain events, such as stock splits, payment of dividends to
common stockholders, reorganizations, mergers or consolidations.
Each share of Preferred Stock automatically converts into shares
of common stock on the tenth day after the day that the closing
sale price of the Companys common stock on the NASDAQ
National Market has reached at least $8.28 and has remained at
such level for 20 consecutive trading days, but only after the
earlier to occur of (1) the unblinding and the public
announcement of the results of the Companys first pivotal
clinical trial of iseganan for the prevention of VAP, or
(2) May 1, 2005. The unblinding of the VAP trial
occurred in June 2004 but since that time the Companys
shares have not traded over $8.28 so automatic conversion has
not occurred. The holders of Preferred Stock are also entitled
to receive, but only out of funds legally available for
dividends, cumulative dividends payable quarterly, at the annual
rate of eight percent of the original issue price of $10,000 on
each outstanding share of Preferred Stock. The dividend will be
paid in common stock based on the average of the closing sales
prices of the common stock on the NASDAQ National Market for the
five trading days immediately preceding and ending on the last
trading day prior to the date the dividends are payable. The
dividends are paid in preference to any other declared
dividends. Upon any liquidation, dissolution or winding up (as
such terms are defined in the Companys Certificate of
Designation) of the Company, before any distribution or payment
can be made to the holders of the Companys common stock,
each holder of Preferred Stock is entitled to receive an amount
equal to $10,000 plus all accrued or declared and unpaid
dividends and such dividends shall be payable in cash. Each
share of Preferred Stock is entitled to a number of votes equal
to the number of shares of common stock issuable based upon a
conversion price
34
NOTES TO FINANCIAL STATEMENTS (Continued)
equal to the closing sale price, or bid price if no sales were
reported, of the common stock on the NASDAQ National Market on
the date the Preferred Stock and Warrant Purchase Agreement was
signed. The number of votes is not adjustable except upon a
stock split, a reverse stock split, or other similar event
affecting the rights of the Preferred Stock. Holders of
Preferred Stock are also entitled to elect two members of the
Board of Directors, and a majority of the holders of the
Preferred Stock must consent to certain actions prior to the
Company taking them.
In connection with the sale of the Preferred Stock, the Company
issued immediately exercisable warrants to
purchase 920,699 shares of the Companys common
stock to the purchasers of the Preferred Stock, at an exercise
price of $2.066 per share, subject to adjustment upon the
occurrence of certain events, such as stock splits, payment of
dividends to common stockholders, reorganizations, mergers or
consolidations. Additionally, the exercise price of the warrants
will be reduced by 50% if the Companys common stock is
delisted from the NASDAQ National Market. The warrants will
expire on May 1, 2008, if not previously exercised. The
warrants issued to the holders of Preferred Stock were assigned
a value of $1,326,000, which decreased the carrying value of the
Preferred Stock. The warrants were valued using the
Black-Scholes method with the following assumptions: a risk-free
interest rate of 2.52%, an expiration date of May 1, 2008,
a volatility factor of 1.00 and a dividend yield of 0%. In
connection with the issuance of the Preferred Stock and
warrants, the Company recorded $1,436,000 related to the
beneficial conversion feature on the Preferred Stock as a deemed
dividend, which increased the loss applicable to common
stockholders in the calculation of basic and diluted net loss
per share. A beneficial conversion feature is present because
the effective conversion price of the Preferred Stock was less
than the fair value of the common stock on the commitment date.
Pursuant to the terms of the Preferred Stock and Warrant
Purchase Agreement, the Company is subject to certain negative
and restrictive covenants, such as limitations on indebtedness
and the issuance of additional equity securities without
specific approvals by the Board of Directors.
Additionally if the Company fails to retain the services of
Henry J. Fuchs, M.D., the Companys Chief Executive
Officer, until the second anniversary of the issuance of
Preferred Stock, then the Company must pay to each holder of
Preferred Stock a one-time payment equal to 15.0% of the
aggregate purchase price for the Preferred Stock. This penalty
will not apply if Dr. Fuchs departure from the
Company is the result of his death, disability or family
emergency or if the Company retains services of an executive
officer to replace Dr. Fuchs within sixty (60) days of
Dr. Fuchs departure, for reasons other than his
death, disability or family emergency, and such replacement is
approved by the Board of Directors. The Company is currently in
compliance with each of the covenants.
In October 2003, a holder of 25 shares of Preferred Stock
converted the shares into 131,529 shares of common stock.
The same investor concurrently exercised warrants to
purchase 65,764 shares of common stock, using the net
exercise method, resulting in the issuance of 55,344 shares
of common stock. There were no cash proceeds to the Company
resulting from these transactions.
The Company had 325 shares of preferred stock outstanding
as of December 31, 2004 and 2003. The Board of Directors
may determine the rights, preferences and privileges of any
preferred stock issued in the future.
In May 2004, in a public offering, the Company sold
3,450,000 shares of newly issued common stock,
$0.001 par value, at $13.00 per share resulting in net
cash proceeds of $41.5 million after issuance costs of
$3.3 million.
In October 2003, in a private placement transaction, the Company
sold 1,774,000 shares of newly issued common stock,
$0.001 par value, at $10.85 per share, and issued
warrants to purchase 354,800 shares of the
Companys common stock, resulting in net cash proceeds of
$18.5 million. The warrants have an exercise price of
$10.85 per share, subject to adjustment upon a subdivision
or combination of the Companys outstanding common stock,
and will expire on October 10, 2008, if not previously
exercised.
35
NOTES TO FINANCIAL STATEMENTS (Continued)
|
|
|
Common Stock Reserved for Future Issuance |
Shares of common stock reserved for future issuance at
December 31, 2004 were as follows:
|
|
|
|
|
|
Equity incentive plans
|
|
|
2,224,145 |
|
Warrants
|
|
|
1,262,235 |
|
Series A convertible preferred stock
|
|
|
1,709,875 |
|
|
|
|
|
|
Total shares reserved for future issuance
|
|
|
5,196,255 |
|
|
|
|
|
In July 2001, the Company issued warrants to
purchase 58,333 shares of the Companys common
stock at an exercise price of $24.00 per share. These
warrants were issued in connection with the termination of the
discovery, development and license agreement with Diversa
Corporation. The warrants will expire on July 27, 2005, if
not previously exercised. The fair value of these warrants was
estimated using the Black-Scholes option pricing model with the
following weighted average assumptions: a risk-free interest
rate of 6%, a contractual life of four years, a volatility
factor of 0.75 and a dividend yield of 0%. The weighted-average
fair value of these warrants was $9.60. The value assigned to
these warrants was $560,000, which was included as part of the
Companys May 2001 restructuring charges.
In December 2002, the Company issued warrants to
purchase 4,167 shares of the Companys common
stock at an exercise price of $3.48 per share. These
warrants were issued in connection with the termination of the
lease agreement with the landlord of certain office facilities.
The warrants will expire on December 31, 2007, if not
previously exercised. The fair value of these warrants was
estimated using the Black-Scholes option pricing model with the
following weighted average assumptions: a risk-free interest
rate of 1.5%, a contractual life of five years, a volatility
factor of 0.50 and a dividend yield of 0%. The weighted-average
fair value of these warrants was $1.56. The value assigned to
these warrants was $6,500, which was included in General
and administrative as part of the Companys 2002
operating expense.
|
|
10. |
Employee Benefit Plans |
The 2004 Stock Incentive Plan (the 2004 Plan) was
adopted in May 2004, and replaced the 2000 Equity Incentive Plan
(the 2000 Plan), which in turn had replaced the 1995
Incentive Stock Plan (the 1995 Plan), collectively
the Predecessor Plans. The termination of the Predecessor Plans
had no effect on the options that were granted thereunder. The
terms of awards granted under the Predecessor Plans were
substantially similar to those granted under the 2004 Plan.
The 2004 Plan allows for the granting of options to purchase
stock, stock bonuses and rights to acquire restricted stock of
up to 2,050,000 shares of common stock to employees,
consultants, and directors. The number of shares of Common Stock
available for issuance under the Plan shall automatically
increase on the first trading day of January each calendar year
during the term of the Plan, beginning with calendar year 2005,
by an amount equal to five percent (5%) of the sum of the
following share numbers, calculated as of the last trading day
in December of the immediately preceding calendar year:
(i) the total number of shares of Common Stock outstanding
on that date and (ii) the number of shares of Common Stock
into which the outstanding shares of the Corporations
preferred stock are convertible on that date. In no event shall
any such annual increase exceed 2,000,000 shares. In
accordance with the preceding formula the shares available for
issuance under the 2004 Plan were increased by 529,510 on
January 1, 2005.
All options granted under the 2004 Plan must have exercise
prices equal to the fair market value of the common stock on the
option grant date, and are to have a term not greater than
10 years from the grant date. Stock options granted under
the 2004 Plan may either be incentive stock options or
nonstatutory stock options.
36
NOTES TO FINANCIAL STATEMENTS (Continued)
The Board of Directors shall determine the time or times during
the term when the options may be exercised and the number of
shares for which an option may be granted, except that no one
person may receive awards for more than 1,000,000 shares of
common stock in the aggregate per calendar year. Options granted
under the 2004 plan vest ratably over a periods ranging from
3 months to six years. Options granted under Predecessor
Plans vest ratably over periods ranging from 18 months to
six years.
The 2002 Non-Officer Equity Incentive Plan (the 2002
Plan) was adopted in August 2002 and allows the granting
of stock awards through nonstatutory stock options, stock
bonuses and rights to acquire restricted common stock of up to
208,333 shares of common stock to employees and consultants
of the Company.
Stock options granted under the 2002 Plan, must be nonstatutory
stock options. Nonstatutory options may be granted with exercise
prices of not less than 85% of the common stock price on the
date of the grant. All options are to have a term not greater
than 10 years from the grant date. The Board of Directors
shall determine the time or times during the term when the
options may be exercised and the number of shares for which an
option may be granted. Options vest ratably over a period
ranging from 18 months to six years.
As of December 31, 2004 there were 1,008,648 and
53,764 shares of common stock available for grant under the
2004 Plan and the 2002 Plan, respectively.
A summary of the Companys stock option activity and
related information is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options | |
|
|
| |
|
|
|
|
Weighted- | |
|
|
Number of | |
|
Average Exercise | |
|
|
Shares | |
|
Price | |
|
|
| |
|
| |
Balance at December 31, 2001
|
|
|
312,370 |
|
|
$ |
52.08 |
|
|
Granted
|
|
|
477,083 |
|
|
$ |
34.68 |
|
|
Exercised
|
|
|
(28,924 |
) |
|
$ |
15.96 |
|
|
Cancelled
|
|
|
(129,194 |
) |
|
$ |
54.12 |
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
631,335 |
|
|
$ |
39.24 |
|
|
Granted
|
|
|
822,527 |
|
|
$ |
2.97 |
|
|
Exercised
|
|
|
(49,863 |
) |
|
$ |
7.68 |
|
|
Cancelled
|
|
|
(581,018 |
) |
|
$ |
40.93 |
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
822,981 |
|
|
$ |
3.73 |
|
|
Granted
|
|
|
1,064,750 |
|
|
$ |
15.01 |
|
|
Exercised
|
|
|
(87,423 |
) |
|
$ |
2.75 |
|
|
Cancelled
|
|
|
(638,575 |
) |
|
$ |
13.97 |
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
1,161,733 |
|
|
$ |
8.51 |
|
|
|
|
|
|
|
|
37
NOTES TO FINANCIAL STATEMENTS (Continued)
At December 31, 2004, 2003, and 2002, options to
purchase 370,087, 165,187 and 211,131 shares of common
stock, respectively, were exercisable. The following table
summarizes information about options outstanding and exercisable
at December 31, 2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding | |
|
Options Exercisable | |
|
|
| |
|
| |
|
|
|
|
Weighted-Average | |
|
Weighted- | |
|
|
|
Weighted- | |
|
|
|
|
Remaining | |
|
Average | |
|
|
|
Average | |
|
|
Number of | |
|
Contractual Life | |
|
Exercise | |
|
Number of | |
|
Exercise | |
Range of Exercise Prices |
|
Shares | |
|
(Years) | |
|
Price | |
|
Shares | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$ 2.28-$ 2.40
|
|
|
21,788 |
|
|
|
5.75 |
|
|
$ |
2.33 |
|
|
|
10,069 |
|
|
$ |
2.38 |
|
$ 2.76-$ 2.76
|
|
|
521,238 |
|
|
|
5.86 |
|
|
$ |
2.76 |
|
|
|
235,343 |
|
|
$ |
2.76 |
|
$ 3.66-$ 5.52
|
|
|
72,812 |
|
|
|
9.34 |
|
|
$ |
4.21 |
|
|
|
10,562 |
|
|
$ |
5.52 |
|
$13.06-$13.53
|
|
|
155,749 |
|
|
|
9.31 |
|
|
$ |
13.12 |
|
|
|
32,664 |
|
|
$ |
13.18 |
|
$13.93-$14.13
|
|
|
176,500 |
|
|
|
9.41 |
|
|
$ |
13.96 |
|
|
|
44,081 |
|
|
$ |
14.01 |
|
$15.60-$48.24
|
|
|
213,646 |
|
|
|
8.96 |
|
|
$ |
16.77 |
|
|
|
37,368 |
|
|
$ |
18.16 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,161,733 |
|
|
|
7.65 |
|
|
$ |
8.51 |
|
|
|
370,087 |
|
|
$ |
6.64 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2000 Employee Stock Purchase Plan |
In January 2000, the Board of Directors adopted the 2000
Employee Stock Purchase Plan (the Purchase Plan),
which was approved by stockholders in February 2000, authorizing
the issuance of 41,666 shares of common stock pursuant to
purchase rights granted to employees. In 2001 and 2002, the
Board of Directors determined not to increase the number of
shares in the reserve. In March 2003, the Purchase Plan was
suspended, and the shares reserved for issuance under this plan
were reduced to zero.
The Purchase Plan is intended to qualify as an employee stock
purchase plan within the meaning of Section 423 of the
Internal Revenue Code of 1986, as amended. Prior to its
suspension, the Purchase Plan permitted eligible employees to
purchase common stock at a discount, but only through payroll
deductions, during defined offering periods. The price at which
stock is purchased under the purchase plan is equal to 85% of
the fair market value of the common stock on the first or last
day of the offering period, whichever is lower. The initial
offering period commenced on the effective date of the initial
public offering.
The Company recorded stock compensation cost as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Stock compensation for variable option awards
|
|
$ |
(638 |
) |
|
$ |
993 |
|
|
$ |
|
|
Amortization of deferred stock compensation expense
|
|
|
61 |
|
|
|
126 |
|
|
|
1,271 |
|
Stock compensation for consultant services
|
|
|
472 |
|
|
|
254 |
|
|
|
512 |
|
Stock compensation for services
|
|
|
|
|
|
|
|
|
|
|
545 |
|
|
|
|
|
|
|
|
|
|
|
|
Total stock compensation expense
|
|
$ |
(105 |
) |
|
$ |
1,373 |
|
|
$ |
2,328 |
|
|
|
|
|
|
|
|
|
|
|
Stock Compensation for Variable Option Awards. 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 newly 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
38
NOTES TO FINANCIAL STATEMENTS (Continued)
outstanding shares and the price of the Companys stock.
During 2004 the Company recorded a stock compensation recovery,
primarily as a result of a stock price decline.
Amortization of Deferred Stock Compensation Expense. 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 and in connection with an
agreement to modify the vesting of one officers unvested
stock options is being amortized to expense on a straight-line
basis over the vesting period of the options, ranging from four
to six years. The vesting schedule of the unexercised portion of
the granted options was changed following their cancellation and
re-grant in February 2003, and consequently the amortization
schedule was also changed to reflect the new four-year vesting
schedule. In connection with the termination of various
employees and cancellation of unvested stock options, the
Company recorded a reduction to deferred stock compensation,
which is a component of stockholders equity, of $13,000,
$406,000 and $2.6 million in the years ended
December 31, 2004, 2003, and 2002, respectively.
Stock Compensation for Consultant Services. In connection
with grants made to consultants the Company recorded stock
compensation expense in accordance with FAS123 and relevant
interpretations.
Stock Compensation for Services. In connection with the
issuance of shares of common stock the Company recorded
compensation expense based on the fair market value of the
common stock on the date of issuance. This expense was recorded
primarily in connection with stock issued to a former landlord
of the Company in connection with a restructuring. See
Note 7 Restructuring and Other
Charges 2001 Restructuring.
The Company has a retirement savings plan (the Savings
Plan) which qualifies as a deferred savings plan under
section 401(k) of the Internal Revenue Code. All employees
are eligible to participate in the Savings Plan and allowed to
contribute up to $14,000 if they are under 50 years old or
$18,000 if they are 50 years old or older in 2004. The
Company is not required to contribute, nor has it contributed,
to the Plan.
|
|
11. |
Development and Supply Contracts |
In January 1997, the Company entered into various development
and supply agreements with PolyPeptide Laboratories A/ S
(PolyPeptide) related to the drug substance
iseganan. In December 2002, the Company reached an agreement to
cancel the existing development and supply agreements (the
Termination Agreement), paid $5.2 million to
PolyPeptide, and accepted delivery of certain lots of drug
substance. Acceptance of the drug substance resulted in a charge
to research and development expense of $4.8 million. At
December 31, 2002, the Company recorded a prepaid for drug
substance of $2.4 million for a partially processed,
undelivered, lot of iseganan (lot I). During 2003,
due to significant uncertainty over the validity of the
manufacturing process used for lot I the Company expensed the
entire prepaid amount of $2.4 million.
In December 2004, the Company accepted delivery of lot I and
paid $250,000 to PolyPeptide. PolyPeptide also released the
Company of its obligation to pay $50,000 per year to store
drug substance. As of December 31, 2004, no additional
amounts are due to or from PolyPeptide.
39
NOTES TO FINANCIAL STATEMENTS (Continued)
The Company had no current state or federal income tax for the
years ended December 31, 2004, 2003, and 2002. The
reconciliation between the amount computed by applying the
U.S. federal statutory tax rate of 34% to pre tax loss and
the actual provision for income taxes was as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
U.S. federal tax benefit at statutory rate
|
|
$ |
(5,678 |
) |
|
$ |
(4,526 |
) |
|
$ |
(11,714 |
) |
|
State taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unutilized net operating losses
|
|
|
5,875 |
|
|
|
4,050 |
|
|
|
10,916 |
|
|
Stock based compensation
|
|
|
(200 |
) |
|
|
467 |
|
|
|
791 |
|
|
Other
|
|
|
3 |
|
|
|
9 |
|
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
Deferred income taxes reflect the net tax effects of temporary
differences between the carrying amounts of assets and
liabilities for financial reporting and the amount used for
income tax purposes. Significant components of the
Companys deferred tax assets are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
Deferred Tax Assets |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Net operating loss carryforwards
|
|
$ |
74,000 |
|
|
$ |
67,700 |
|
Research and development tax credit carryforwards
|
|
|
5,500 |
|
|
|
5,500 |
|
Capitalized research and development costs
|
|
|
8,200 |
|
|
|
7,500 |
|
Other, net
|
|
|
100 |
|
|
|
|
|
|
|
|
|
|
|
|
Gross deferred tax assets
|
|
|
87,800 |
|
|
|
80,700 |
|
Valuation allowance
|
|
|
(87,800 |
) |
|
|
(80,700 |
) |
|
|
|
|
|
|
|
Total deferred tax assets
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
Realization of deferred tax assets is dependent upon future
earnings, if any, the timing and amount of which are uncertain.
Accordingly, the net deferred tax assets have been fully offset
by a valuation allowance. The valuation allowance increased by
$7.1 million, $5.6 million and $11.4 million
during 2004, 2003 and 2002, respectively.
As of December 31, 2004, the Company had net operating loss
carryforwards for federal income tax purposes of approximately
$211.0 million, which expire in the years 2009 through
2024, and federal research and development credits of
approximately $3.3 million, which expire in the years 2009
through 2024. In addition, the Company had net operating loss
carryforwards for state income tax purposes of approximately
$38.0 million, which expire in the years 2004 through 2016
and state research and development tax credits of approximately
$3.3 million, which do not expire.
Utilization of the Companys net operating loss may be
subject to substantial annual limitation due to the ownership
change limitations provided by the Internal Revenue Code and
similar state provisions. Such an annual limitation could result
in the expiration of the net operating loss before utilization.
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
40
NOTES TO FINANCIAL STATEMENTS (Continued)
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.
|
|
14. |
Quarterly Financial Data (Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
|
First | |
|
Second | |
|
Third | |
|
Fourth | |
|
First | |
|
Second | |
|
Third | |
|
Fourth | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands, except per share amounts) | |
Operating loss
|
|
$ |
(6,310 |
) |
|
$ |
(5,252 |
) |
|
$ |
(4,007 |
) |
|
$ |
(1,627 |
) |
|
$ |
(1,933 |
) |
|
$ |
(2,395 |
) |
|
$ |
(4,766 |
) |
|
$ |
(4,415 |
) |
Net loss
|
|
|
(6,237 |
) |
|
|
(5,138 |
) |
|
|
(3,961 |
) |
|
|
(1,364 |
) |
|
|
(1,907 |
) |
|
|
(2,350 |
) |
|
|
(4,738 |
) |
|
|
(4,317 |
) |
Net loss applicable to common stockholders
|
|
|
(6,302 |
) |
|
|
(5,203 |
) |
|
|
(4,026 |
) |
|
|
(1,429 |
) |
|
|
(1,907 |
) |
|
|
(3,815 |
) |
|
|
(4,808 |
) |
|
|
(4,400 |
) |
Basic and diluted net loss per share applicable to common
stockholders
|
|
$ |
(1.19 |
) |
|
$ |
(0.73 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.16 |
) |
|
$ |
(0.58 |
) |
|
$ |
(1.17 |
) |
|
$ |
(1.46 |
) |
|
$ |
(0.87 |
) |
41
|
|
Item 9. |
Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure |
On November 12, 2004, Ernst & Young LLP resigned
as the Companys independent registered public accounting
firm. The reports of Ernst & Young LLP on the
Companys financial statements for the past two fiscal
years ended December 31, 2003 did not contain an adverse
opinion or a disclaimer of opinion and were not qualified or
modified as to uncertainty, audit scope, or accounting
principles. In connection with the audits of the Companys
financial statements for each of the two fiscal years ended
December 31, 2003, and in the subsequent interim period,
through November 12, 2004, there were no disagreements with
Ernst & Young LLP on any matters of accounting
principles or practices, financial statement disclosure, or
auditing scope and procedures which, if not resolved to the
satisfaction of Ernst & Young LLP would have caused
Ernst & Young LLP to make reference to the matter in
their report. There were no reportable events as
that term is described in Item 304(a)(1)(v) of
Regulation S-K. The resignation of Ernst & Young
LLP was approved by the Audit Committee of the Companys
Board of Directors.
On October 11, 2004, IntraBiotics Pharmaceuticals, Inc.
(the Company) entered into an engagement letter with
Stonefield Josephson, Inc. (Stonefield Josephson) to
serve as the Companys independent registered public
accounting firm for the fiscal year ended December 31,
2004. Stonefield Josephsons engagement as the
Companys new auditors became effective after the filing of
the Companys Form 10-Q for the quarter ended
September 30, 2004. The Companys engagement of
Stonefield Josephson was approved by its Audit Committee.
During the Companys two most recent fiscal years and the
subsequent interim period prior to the engagement of Stonefield
Josephson, the Company did not consult with Stonefield Josephson
with respect to any of the matters or events set forth in
Item 304(a)(2)(i) or (ii) of Regulation S-K. The
Companys engagement of Stonefield Josephson was approved
by the Audit Committee.
|
|
Item 9A. |
Controls and Procedures |
|
|
|
Controls Evaluation and Related CEO and PFO
Certifications |
We have evaluated the effectiveness of the design and operation
of our disclosure controls and procedures, as such term is
defined in Rule 13a-15(e) under the Securities Exchange Act
of 1934, as of the end of the period covered by this Report. The
controls evaluation was done under the supervision and with the
participation of management, including our Chief Executive
Officer (CEO) and Principal Financial Officer
(PFO) and has allowed us to make conclusions, as set forth
below, regarding the state of our disclosure controls and
procedures.
Attached as exhibits to this Report are certifications of the
CEO and the PFO, which are required in accordance with
Rule 13a-14 of the Exchange Act. This Controls and
Procedures section includes the information concerning the
controls evaluation referred to in the certifications, and it
should be read in conjunction with the certifications for a more
complete understanding of the topics presented.
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Disclosure Controls and Procedures |
Our disclosure controls and procedures are designed to provide
reasonable assurance that information required to be disclosed
in our reports filed under the Exchange Act, such as this
Report, is recorded, processed, summarized and reported within
the time periods specified in the Securities and Exchange
Commissions rules and forms. Our disclosure controls and
procedures are also designed to ensure that such information is
accumulated and communicated to our management, including the
CEO and PFO, to allow timely decisions regarding required
disclosure. Our disclosure controls include components of our
internal control over financial reporting, which consists of
control processes designed to provide reasonable assurance
regarding the reliability of our financial reporting and the
preparation of financial statements in accordance with generally
accepted accounting principles in the United States. To the
extent that components of our internal control over financial
reporting are included within our disclosure controls, they are
included in the scope of our quarterly controls evaluation.
42
|
|
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Limitations on the Effectiveness of Controls |
Management, including our CEO and PFO, does not expect that our
disclosure controls and procedures or our internal control over
financial reporting will prevent all error and all fraud. A
control system, no matter how well conceived and operated, can
provide only reasonable, not absolute, assurance that the
objectives of the control system will be attained. Furthermore,
the design of a control system must reflect the fact that there
are resource constraints and the benefits of controls must be
considered relative to their costs. Because of the inherent
limitations in a cost-effective control system, no evaluation of
controls can provide absolute assurance that all misstatements
due to error or fraud, if any, may occur and not be detected on
a timely basis. These inherent limitations include the
possibility that judgments in decision-making can be faulty and
that breakdowns can occur because of errors or mistakes. Our
disclosure controls and procedures can also be circumvented by
the individual acts of some persons, by collusion of two or more
people or by management override of the controls. The design of
any system of controls is based in part on certain assumptions
about the likelihood of future events and there can be no
assurance that any design will succeed in achieving its stated
goals under all potential future conditions. Furthermore,
controls may become inadequate because of changes in conditions
or deterioration in the degree of compliance with policies or
procedures.
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Scope of the Controls Evaluation |
The evaluation of our disclosure controls and procedures
included a review of the controls objectives and design,
the Companys implementation of the controls and the effect
of the controls on the information generated for use in this
Report. During the evaluation of our controls and procedures, we
looked to identify data errors, control problems or acts of
fraud and confirm that appropriate corrective action (including
process improvements) was being undertaken. This evaluation is
performed on a quarterly basis so that the conclusions of
management, including the CEO and PFO, concerning the
effectiveness of the disclosure controls and procedures can be
reported in our Quarterly Reports on Form 10-Q and to
supplement our disclosures made in our Annual Report on
Form 10-K. The overall goal of the evaluation activity is
to monitor our disclosure controls and procedures, and to modify
them as necessary. We intend to maintain our disclosure controls
and procedures as a dynamic system that changes as conditions
warrant.
We also considered whether our evaluation identified any
significant deficiencies or material
weaknesses in our internal control over financial
reporting, and whether we identified any acts of fraud involving
personnel with a significant role in our internal control over
financial reporting. Emphasis was placed on this information as
it was important both for the controls evaluation and because
item 5 in the certifications of the CEO and PFO requires
that they disclose that information to our Board of
Directors Audit Committee and to our independent auditors.
In the professional auditing literature, significant
deficiencies are defined as a control deficiency, or
combination of deficiencies, that adversely affects the
companys ability to initiate, authorize, record, process
or report external financial data reliably in accordance with
generally accepted accounting principles such that there is more
than a remote likelihood that a misstatement of the
companys financial statements that is more than
inconsequential will not be prevented or detected. Auditing
literature defines material weakness as a
significant deficiency, or combination of significant
deficiencies, that results in more than a remote likelihood that
a material misstatement of the financial statements will not be
prevented or detected.
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Changes in Internal Control Over Financial
Reporting |
There was no change in our internal control over financial
reporting during the quarter ended December 31, 2004 that
has materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
Based upon the evaluation of the effectiveness of our disclosure
controls and procedures, our CEO and PFO have concluded that our
disclosure controls and procedures were effective to provide
reasonable
43
assurance that material information required to be included in
our Exchange Act reports, is made known to management, including
the CEO and PFO, on a timely basis.
Pursuant to section 404 of Sarbanes-Oxley Act of 2002, we
will be required to furnish a report of managements
assessment of the effectiveness of our internal control over
financial reporting as part of our Annual Report on
Form 10-K for the fiscal year ended December 31,
2006. Our independent public accountants will then be required
to attest to, and report on, our assessment. In order to issue
our report, management must document both the design of our
internal controls and the processes that support
managements evaluation and conclusion. Our management has
begun the necessary processes and procedures for issuing its
report. However, we may face significant challenges in
implementing the required processes and procedures. There can be
no assurance that we will be able to complete the work necessary
for management to issue its report in a timely manner or that
management will be able to report that our internal control over
financial reporting are effective.
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Item 9B. |
Other Information |
Not applicable.
PART III
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Item 10. |
Directors and Executive Officers of the Registrant |
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Executive Officers and Directors |
The following table sets forth certain information regarding the
directors and executive officers of IntraBiotics as of
February 28, 2005:
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|
Name |
|
Age | |
|
Position with the Company |
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|
| |
|
|
Ernest Mario, Ph.D.(1)
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|
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66 |
|
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Chairman of the Board |
Henry J. Fuchs, M.D.
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|
47 |
|
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President, Chief Executive Officer and Director |
Jerry T. Jackson(1)(2)(3)
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|
|
63 |
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|
Director |
Gary A. Lyons(2)(3)
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|
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53 |
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Director |
Mark L. Perry, J.D.(1)(2)(3)
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|
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49 |
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Director |
Jack S. Remington, M.D.
|
|
|
74 |
|
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Director |
Kevin C. Tang
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37 |
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Director |
Kathleen A. Stafford
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|
|
47 |
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Principal Financial Officer |
Steven B. Ketchum, Ph. D.
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40 |
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Senior Vice President of Operations & Regulatory Affairs |
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(1) |
Member of the Nominating and Corporate Governance Committee |
|
(2) |
Member of the Compensation Committee |
|
(3) |
Member of the Audit Committee |
Ernest Mario, Ph.D. Dr. Mario has served as
Chairman of the Board of IntraBiotics since April 2002. From
April 2002 to January 2003, Dr. Mario also served as
IntraBiotics Chief Executive Officer. From February 2003
to the present, Dr. Mario has served as Chairman and Chief
Executive Officer of Reliant Pharmaceuticals. In January 2002,
Dr. Mario founded Apothogen, Inc., or Apothogen, a
pharmaceutical company where he served as Chairman and Chief
Executive Officer until Apothogen was acquired by IntraBiotics
in April 2002. Dr. Mario was the Chairman and Chief
Executive Officer of ALZA Corporation, a pharmaceutical company,
from 1993 until June 2001. Prior to joining ALZA, Dr. Mario
served as Chief Executive of Glaxo Holdings plc, or Glaxo
Holdings, a pharmaceutical company, from May 1989 to March 1993,
and as Deputy Chairman from January 1992 to March 1993. Prior to
that time, Dr. Mario served as Chairman and Chief Executive
Officer of Glaxo, Inc., a subsidiary of Glaxo Holdings, from
1988 to 1989 and
44
as President and Chief Operating Officer of Glaxo, Inc. from
1986 to 1988. Prior to joining Glaxo, Inc., Dr. Mario held
various executive positions at Squibb Corporation and served as
a director of that company. Dr. Mario is also a director of
Pharmaceutical Product Development, Inc., Boston Scientific
Corporation and Maxygen, Inc. Dr. Mario earned a B.S.
degree in Pharmacy at Rutgers University and masters and
doctoral degrees in Physical Sciences at the University of Rhode
Island and also holds honorary doctorates from the University of
Rhode Island and Rutgers University.
Henry J. Fuchs, M.D. Dr. Fuchs has served as a
director of IntraBiotics since November 2001 and as Chief
Executive Officer since January 2003. Dr. Fuchs joined
IntraBiotics as Vice President, Clinical Affairs in October 1996
and was appointed President and Chief Operating Officer in
November 2001. From 1987 to 1996, Dr. Fuchs held various
positions at Genentech, Inc., a biotechnology company, where,
among other things, he had responsibility for the clinical
program that led to the approval for Genentechs
Pulmozyme®. Dr. Fuchs was also responsible for the
Phase III development program that led to the approval of
Herceptin® to treat metastatic breast cancer.
Dr. Fuchs received an M.D. degree from George Washington
University and a B.A. degree in biochemical sciences from
Harvard University.
Jerry T. Jackson. Mr. Jackson has served as a
director of IntraBiotics since August 2002. Mr. Jackson is
currently and has been retired since 1995. Mr. Jackson was
employed by Merck & Co., Inc., a major pharmaceutical
company, from 1965 until his retirement in 1995. During this
time, he had extensive experience in sales, marketing and
corporate management, including joint ventures. From 1993 until
retirement, Mr. Jackson served as Executive Vice President
of Merck with broad responsibilities for numerous operating
groups, including being President of Mercks Worldwide
Human Health Division in 1993 and Senior Vice President
responsible for Mercks Specialty Chemicals Business from
1991 to 1992. Previously, he was President of Mercks
International Division. Mr. Jackson has served on the board
of directors of several biotech pharmaceutical companies and
currently serves as a director of Myogen, Inc. Mr. Jackson
received a B.A. degree in Education from the University of New
Mexico in 1964.
Gary A. Lyons. Mr. Lyons has served as a director of
IntraBiotics since December 1999. Mr. Lyons has served as
President and Chief Executive Officer of Neurocrine Biosciences,
Inc., a publicly traded biopharmaceutical company from 1993 to
the present. From 1983 to 1993, Mr. Lyons was affiliated
with Genentech, Inc. and served as Vice President of Business
Development and Vice President of Sales. He is a member of the
board of directors of Vical Inc. Mr. Lyons holds a B.S.
degree in Marine Biology from the University of New Hampshire
and an M.B.A. degree from Northwestern Universitys J.L.
Kellogg Graduate School of Management.
Mark L. Perry, J.D. Mr. Perry has served as a
director of IntraBiotics since September 2003. Mr. Perry is
the Senior Business Advisor for Gilead Sciences, Inc. reporting
to the CEO. Mr. Perry was an executive officer of Gilead
Sciences, Inc. from 1994 to 2004, serving in a variety of
capacities, including General Counsel, Chief Financial Officer
and most recently Executive Vice President of Operations
responsible for worldwide sales & marketing, legal,
manufacturing and facilities. From 1981 to 1994, Mr. Perry
was with the law firm Cooley Godward LLP in San Francisco
and Palo Alto, serving as a partner of the firm from 1987 to
1994. Mr. Perry received his J.D. degree from the
University of California, Davis in 1980 and is a member of the
California bar. Mr. Perry is a member of the Board of
Nuvelo, Inc and Aerovance Inc.
Jack S. Remington, M.D. Dr. Remington has
served as a director of IntraBiotics since October 1996.
Dr. Remington currently serves and has served as Professor,
Department of Medicine, Division of Infectious Diseases and
Geographic Medicine, at the Stanford University School of
Medicine and as Chairman of the Department of Immunology and
Infectious Diseases at the Research Institute of the Palo Alto
Medical Foundation for nearly four decades. In addition,
Dr. Remington is a consultant for leading pharmaceutical
companies with regard to antibiotic research and development and
serves on numerous editorial boards of medical journals. He is a
past President of the Infectious Disease Society of America.
Dr. Remington is a nationally recognized authority in the
field of infectious disease medicine, and received the 1996
Bristol Award of the Infectious Disease Society of America.
Kevin C. Tang. Mr. Tang has served as a director of
IntraBiotics since May 2003. Mr. Tang is the Managing
Director of Tang Capital Management, LLC, a life
sciences-focused investment company he
45
founded in August 2002. Mr. Tang was a consultant from
August 2001 to July 2002. From September 1993 to July 2001,
Mr. Tang held various positions at Deutsche Banc Alex.
Brown, Inc., an investment banking firm, most recently serving
as Managing Director and head of the firms life sciences
research group. Mr. Tang currently serves as a director of
Trimeris, Inc. Mr. Tang received a B.S. degree from Duke
University.
Kathleen A. Stafford. Ms. Stafford was appointed
Principal Financial Officer in November 2004. From February 2004
to October 2004 Ms. Stafford served as a financial
consultant for IntraBiotics. Beginning in 1989,
Ms. Stafford served in senior financial positions in the
biotechnology industry, including serving as the chief financial
officer for Onyx Pharmaceuticals, Inc., CV Therapeutics, Inc.
and Axys Pharmaceuticals, Inc. (which was later acquired by
Celera Genomics Group in November 2001) and serving as the
treasurer for Amgen, Inc. Ms. Stafford has also served as a
financial consultant for several biotechnology companies. From
July 2004 to September 2004 and from May 2000 to August 2000,
Ms. Stafford served as a financial consultant for Dynavax
Technologies. From September 2000 to January 2004,
Ms. Stafford earned a professional clear multiple subject
teaching credential and served as a teacher for the Oakland
Unified School District and Piedmont Unified School District.
From September 1999 to April 2000, Ms. Stafford served as
the chief financial officer for Axys Pharmaceuticals.
Ms. Stafford holds a B.S. in combined science from
Santa Clara University and an M.B.A. from Virginia
Polytechnic Institute.
Steven B. Ketchum Ph.D. Dr. Ketchum joined
IntraBiotics and was appointed Vice President of Regulatory
Affairs in June 2002 and was promoted to Senior Vice President
of Operations and Regulatory Affairs in June 2004. From November
1994 through May 2002, Dr. Ketchum held a series of
regulatory affairs positions at ALZA Corporation, most recently
as Senior Director of Regulatory Affairs. During his tenure at
ALZA, Dr. Ketchum was responsible for supporting the
development, registration and commercialization of a range of
ALZAs urology (Ditropan XL®, Testoderm TTS®, and
Elmiron®) and CNS products (Concerta®) in North
America and Europe. He started his regulatory career in Geneva
within the fertility products registration group at Ares-Serono,
a biopharmaceutical company based in Switzerland.
Dr. Ketchum received his Ph.D. degree in Pharmacology from
University College London under a fellowship sponsored by the
Swiss pharmaceuticals company Sandoz (now part of Novartis), and
conducted postdoctoral research in molecular neurobiology in
Geneva at the Glaxo Institute for Molecular Biology (now part of
Ares-Serono). He received his B.S. degree in Biological Sciences
from Stanford University.
Section 16(a) Beneficial Ownership Reporting
Compliance
Section 16(a) of the Securities Exchange Act of 1934, as
amended (the Exchange Act) requires
IntraBiotics directors and executive officers, and persons
who own more than ten percent of common stock and other equity
securities of IntraBiotics to file with the SEC initial
reports of ownership and reports of changes in ownership of
common stock and other equity securities of IntraBiotics.
Officers, directors and greater than ten percent stockholders
are required by SEC regulation to furnish IntraBiotics with
copies of all Section 16(a) forms they file.
SEC regulations require us to identify in this proxy statement
anyone who filed a required report late during the most recent
fiscal year. To IntraBiotics knowledge, based solely on a
review of the copies of such reports furnished to IntraBiotics
and written representations that no other reports were required,
during the fiscal year ended December 31, 2004, all
Section 16(a) filing requirements applicable to its
officers, directors and greater than ten percent beneficial
owners were satisfied on a timely basis.
Code of Business Conduct and Ethics
IntraBiotics has adopted a Code of Business Conduct and Ethics
that applies to all officers, directors, employees and other
persons performing similar functions. A copy of this Code of
Business Conduct and Ethics can be viewed at the
IntraBiotics website located at www.intrabiotics.com. The
code of ethics meets the requirements defined by Item 406
of Regulation S-K.
46
Board Committees and Meetings
During the fiscal year ended December 31, 2004 the Board
held ten (10) meetings including telephone conference
meetings and acted by unanimous written consent once. During the
fiscal year ended December 31, 2004, each member of the
Board attended 75% or more of the aggregate of the meetings of
the Board and of the committees on which he or she served, held
during the period for which he or she was a director or
committee member, respectively.
The Board has an Audit Committee, a Compensation Committee and a
Nominating and Corporate Governance Committee.
Audit Committee. The Audit Committee of the Board of
IntraBiotics oversees IntraBiotics accounting and
financial reporting process and audits of the financial
statements. For this purpose, the Audit Committee performs
several functions. The Audit Committee monitors
IntraBiotics systems of internal controls; evaluates the
performance of and assesses the qualifications of the
independent auditors; determines the engagement of the
independent auditors; determines whether to retain or terminate
the existing independent auditors or to appoint and engage new
independent auditors; reviews and approves the retention of the
independent auditors to perform any proposed permissible
non-audit services; monitors the rotation of partners of the
independent auditors on IntraBiotics engagement team as required
by law; reviews the financial statements to be included in
IntraBiotics Annual Report on Form 10-K and quarterly
reports on Form 10-Q; and discusses with management and the
independent auditors the results of the annual audit and the
results of IntraBiotics quarterly financial statements.
Three directors comprise the Audit Committee: Mr. Perry,
Mr. Lyons and Mr. Jackson. Mr. Perry is
Chairperson of the Audit Committee. The Audit Committee met six
(6) times during 2004. All members of IntraBiotics
Audit Committee are independent under applicable SEC and NASDAQ
rules. In addition, the Board has determined that at least one
of the independent directors serving on the Audit Committee,
Mr. Perry, is an audit committee financial
expert as defined by Item 401(h) of
Regulation S-K of the Exchange Act.
Compensation Committee. The Compensation Committee
reviews and approves the overall compensation strategy and
policies for IntraBiotics. The Compensation Committee reviews
and approves corporate performance goals and objectives relevant
to the compensation of IntraBiotics executive officers and
other senior management; reviews and approves the compensation
and other terms of employment of IntraBiotics Chief
Executive Officer; and administers IntraBiotics stock
option and purchase plans, pension and profit sharing plans,
stock bonus plans, deferred compensation plans and other similar
programs. Three directors comprise the Compensation Committee:
Mr. Lyons, Mr. Perry, and Mr. Jackson.
Mr. Lyons is Chairperson of the Compensation Committee. All
members of IntraBiotics Compensation Committee are
independent under applicable SEC and NASDAQ rules. The
Compensation Committee met three (3) times during 2004 and
acted by unanimous written consent two (2) times.
Nominating and Corporate Governance Committee. The Board
formed a Nominating and Corporate Governance Committee in March
2004 and it adopted a charter. A copy of the charter is
available on the IntraBiotics website, www.intrabiotics.com. The
Nominating and Corporate Governance Committee identifies
individuals qualified to become members of the Board and
recommends such persons to be nominated by the Board for
election as directors at the annual meeting of stockholders. The
Nominating and Corporate Governance Committee will consider and
make recommendations to the Board regarding any stockholder
recommendations for candidates to serve on the Board. However,
it has not adopted a formal process for that consideration
because it believes that the informal consideration process has
been adequate given the historical absence of stockholder
proposals. The Nominating and Corporate Governance Committee
will review periodically whether a more formal policy should be
adopted. Stockholders wishing to recommend candidates for
consideration by the Nominating and Corporate Governance
Committee may do so by writing to the Secretary of IntraBiotics
at 2483 East Bayshore Road, Suite 100, Palo Alto, CA,
94303, providing the candidates name, biographical data
and qualifications at least 120 days prior to the mailing
of the notice of the next annual meeting to assure meaningful
consideration by the Nominating and Corporate Governance
Committee. There are no differences in the manner in which the
Nominating and Corporate Governance Committee evaluates nominees
for director based on whether the nominee is recommended by a
stockholder.
47
Directors are not required to meet any specific or minimum
qualifications. The Committee does, however, use certain
evaluation criteria as a guide in its selection process, which
are included in the charter. IntraBiotics has not paid any third
party to identify or assist in identifying or evaluating
potential nominees. The Committee is also responsible for
reviewing with the Board, on an annual basis, the requisite
skills and criteria for new Board members as well as the
composition of the Board as a whole. The Committee is required
to review the qualifications and backgrounds of all directors
and nominees (without regard to whether a nominee has been
recommended by stockholders), as well as the overall composition
of the Board, and recommend a slate of directors to be nominated
for election at the annual meeting of stockholders, or, in the
case of a vacancy on the Board, recommend a director to be
elected by the Board to fill such vacancy. Three directors
comprise the Nominating and Corporate Governance Committee:
Dr. Mario, Mr. Jackson and Mr. Perry.
Dr. Mario is Chairperson of the Nominating and Corporate
Governance Committee. All members of IntraBiotics
Nominating and Corporate Governance Committee are independent
under applicable SEC and NASDAQ rules. Members of the Nominating
and Corporate Governance Committee are appointed by the Board.
The Nominating and Corporate Governance Committee met once
during 2004.
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Item 11. |
Executive Compensation |
Directors Compensation
In 2004 members of the Board received an annual cash retainer
fee of $10,000 and were reimbursed for reasonable expenses in
attending Board meetings. During the 2004 year, all Board
members were eligible to participate in the 2000 Equity
Incentive Plan (the 2000 Plan).
Pursuant to the option grant formula program under such plan,
each newly-appointed or elected non-employee Board member
receives an automatic option grant for 10,000 shares at the
time he or she becomes a non-employee Board member, and such
option will vest in a series of three equal successive annual
installments upon his completion of each year of Board service
over the three year period measured from the grant date. In
addition, at the first regularly scheduled Board meeting each
year, each individual serving as a non-employee Board member at
that time receives an option grant to
purchase 5,000 shares of common stock. In addition,
each non-employee Board member serving at that time as a member
of a Board committee also receives an option grant to
purchase 2,500 shares of common stock for each Board
committee of which he or she is a member. Each of these formula
grants made pursuant to the 2000 Plan is to have an exercise
price per share equal to the fair market value per share of
IntraBiotics common stock on the date immediately preceding the
grant date and a maximum term of 10 years, subject to
earlier termination upon the optionees cessation of Board
service. Each 5,000-share and 2,500-share option grant vests
upon the optionees completion of one year of Board service
measured from the grant date. Under the 2000 Plan additional
option grants could also be awarded to one or more continuing
non-employee Board members on a discretionary, non-formula basis.
Option grants for the 2004 fiscal year were made to the
non-employee Board members on February 2, 2004 in
accordance with the existing formula grant program in effect for
them pursuant to the 2000 Plan, as that program is summarized
above. Accordingly, each of the following non-employee Board
members received option grants for the indicated number of
shares with an exercise price of $16.49 per share in
connection with their Board or Board committee service:
Dr. Mario (5,000 shares), Dr. Remington
(5,000 shares), Mr. Perry (10,000 shares),
Mr. Jackson (10,000 shares), Mr. Lyons
(10,000 shares) and Mr. Tang (5,000 shares).
On February 2, 2004, Mr. Jackson, Mr. Lyons and
Dr. Remington each received an additional option grant to
purchase 10,000 shares of common stock with an
exercise price of $16.49 per share. Each option will vest
upon each such directors completion of one year of Board
service measured from the grant date, subject to earlier
termination upon cessation of Board service.
Upon shareholder approval of the Companys 2004 Stock
Incentive Plan (the 2004 Plan) at the 2004 Annual
Meeting, the 2000 Plan terminated, and, beginning in 2005,
newly-appointed and continuing non-employee Board members will
receive option grants pursuant to the automatic option grant
program in effect for them under the new 2004 Plan, as described
below. Following shareholder approval of the 2004 Plan at the
2004 Annual Meeting, additional option grants could also be
awarded to one or more continuing non-employee Board members on
a discretionary, non-formula basis.
48
On June 11, 2004, Mr. Jackson, Dr. Mario and
Mr. Perry each received an option grant under the 2004 Plan
to purchase 2,500, 5,000 and 2,500 shares of common
stock, respectively, with an exercise price of $13.93 per
share. Each option will vest upon each such directors
completion of one year of Board service measured from the grant
date, subject to earlier termination upon cessation of Board
service. In addition, the Board granted to Messrs. Jackson,
Lyons, Perry, and Tang and Doctors Remington and Mario under the
2004 Plan an option grant to purchase 15,000, 17,500,
20,000, 25,000, 15,000 and 35,000 shares of common stock,
respectively, with an exercise price of $13.93 per share.
The shares subject to each such option grant will vest monthly
over three years from the grant date, provided that the optionee
continues to serve as a member of the Board service. All of the
options are immediately exercisable for all of the option
shares, however, any shares purchased under the option will be
subject to repurchase by IntraBiotics, at the lower of the
exercise price paid per share or the fair market value per
share, should the optionee cease Board service prior to the
vesting in those shares.
Beginning in January 2005 newly-appointed and continuing
non-employee Board members will receive option grants pursuant
to the automatic option grant program in effect for them under
the new 2004 Plan. Accordingly, on the first trading date in
January each year, beginning January 2005, each individual
serving as a non-employee Board member at that time will
automatically be granted an option under the 2004 Plan to
purchase 10,000 shares of common stock. In addition,
each non-employee Board member who is serving at that time as a
member of the Audit Committee, Compensation Committee or the
Nominating and Corporate Governance Committee will also receive
an automatic option grant under the 2004 Plan to
purchase 2,500 shares of common stock for each of
those committees of which he or she is a member, except that the
option grant for the Chair of the Audit Committee will be for
7,500 shares and the option grant for the Chair of the
Compensation Committee and the Nominating and Corporate
Governance Committees will each be for 5,000 shares. In
addition, each newly-appointed or elected non-employee Board
member will receive an automatic option grant for
25,000 shares at the time he or she becomes a non-employee
Board member. Each automatic option grant under the 2004 Plan
will have an exercise price per share equal to the fair market
value per share of IntraBiotics common stock on the date
immediately preceding the grant date and will have a maximum
term of 10 years, subject to earlier termination upon the
optionees cessation of Board service. Each annual option
grant made to any continuing Board and Committee member will
vest upon the optionees completion of one year of Board
service measured from the grant date. Each initial
25,000 share option will vest in a series of thirty-six
equal successive monthly installments upon the optionees
completion of each month of Board service over the thirty-six
month period measured from the grant date.
Option grants were made to the non-employee Board members on
January 3, 2005 in accordance with the existing formula
grant program in effect for them pursuant to the 2005 Plan, as
that program is summarized above. Accordingly, each of the
following non-employee Board members received option grants for
the indicated number of shares with an exercise price of
$4.08 per share in connection with their Board or Board
committee service: Dr. Mario (15,000 shares),
Dr. Remington (10,000 shares), Mr. Perry
(22,500 shares), Mr. Jackson (17,500 shares),
Mr. Lyons (17,500 shares) and Mr. Tang
(10,000 shares).
In the event of a sale or disposition of substantially all of
the securities or assets of IntraBiotics, a merger of
IntraBiotics with or into another corporation or a consolidation
or other change of control transaction involving IntraBiotics,
all of the foregoing option grants made to the non-employee
directors will fully vest and become immediately exercisable for
vested shares as of the effective date of the change of control
of IntraBiotics.
On April 1, 2003 we entered into a consulting agreement
with Michael Bigham in connection with the termination of his
board service. The term of the agreement ran from
September 9, 2003 to September 9, 2004. Pursuant to
the agreement, Mr. Bigham was to be paid a consulting fee
of $200 per hour for services rendered. During the term of
the agreement we did not pay Mr. Bigham any hourly
consulting fee. For the term of the agreement, stock options
granted to Mr. Bigham continued to vest.
On September 9, 2003 we entered into a consulting agreement
with Kathleen LaPorte in connection with the termination of her
board service. The term of the agreement ran from April 1,
2003 to April 1, 2004. Pursuant to the agreement,
Ms. LaPorte was to be paid a consulting fee of
$200 per hour for services rendered.
49
During the term of the agreement we did not pay Ms. LaPorte
any hourly consulting fee. For the term of the agreement, stock
options granted to Ms. LaPorte continued to vest.
Executive Compensation
The following table shows for the fiscal years ended
December 31, 2004, 2003 and 2002, compensation awarded or
paid to, or earned by (i) our Chief Executive Officer,
(ii) two other executive officer whose annual salary and
bonus for fiscal year 2004 exceeded $100,000, and (iii) two
other executive officers who would otherwise have been included
in the table by reason of their salary and bonus for fiscal year
2004, but for the fact that they were not acting as executive
officers at the end of the year (the Named Executive
Officers). In accordance with the rules of the
Securities and Exchange Commission, the compensation described
in this table does not include medical, group life insurance or
other benefits received by the Named Executive Officers that are
available generally to all our salaried employees. In addition,
it does not include certain perquisites and other personal
benefits received by the Named Executive Officers, which do not
exceed the lesser of $50,000 or 10% of total annual salary and
bonus.
Summary Compensation Table
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Long Term | |
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|
Compensation | |
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| |
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Annual Compensation | |
|
Securities | |
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| |
|
Underlying | |
|
All Other | |
Name and Principal Position |
|
Year | |
|
Salary ($) | |
|
Bonus ($) | |
|
Options | |
|
Compensation ($) | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Henry J. Fuchs, M.D.(1)
|
|
|
2004 |
|
|
|
360,000 |
|
|
|
|
|
|
|
160,000 |
|
|
|
10,808 |
|
|
President and Chief Executive Officer |
|
|
2003 |
|
|
|
313,750 |
|
|
|
40,000 |
|
|
|
200,000 |
|
|
|
|
|
|
|
|
|
2002 |
|
|
|
308,333 |
|
|
|
85,000 |
|
|
|
41,667 |
|
|
|
|
|
Kathleen A. Stafford(2)
|
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2004 |
|
|
|
150,000 |
|
|
|
|
|
|
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22,000 |
|
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|
Principal Financial Officer |
|
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2003 |
|
|
|
|
|
|
|
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|
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|
|
|
|
|
|
2002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steven B. Ketchum, Ph. D(3)
|
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|
2004 |
|
|
|
256,515 |
|
|
|
|
|
|
|
70,000 |
|
|
|
|
|
|
Senior Vice President of |
|
|
2003 |
|
|
|
235,083 |
|
|
|
20,000 |
|
|
|
125,000 |
|
|
|
|
|
|
Operations & Regulatory Affairs |
|
|
2002 |
|
|
|
131,250 |
|
|
|
|
|
|
|
12,500 |
|
|
|
|
|
Detlef Albrecht, M.D.(4)
|
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|
2004 |
|
|
|
130,272 |
|
|
|
50,000 |
|
|
|
210,000 |
|
|
|
222,381 |
|
|
Sr. Vice President, Pre-Clinical and |
|
|
2003 |
|
|
|
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|
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|
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|
|
|
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Clinical Research and Development |
|
|
2002 |
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and Chief Medical Officer |
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|
|
David J. Tucker(5)
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2004 |
|
|
|
147,000 |
|
|
|
|
|
|
|
40,500 |
|
|
|
136,432 |
|
|
Principal Financial Officer |
|
|
2003 |
|
|
|
100,530 |
|
|
|
3,750 |
|
|
|
21,000 |
|
|
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|
2002 |
|
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|
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|
|
|
|
|
|
(1) |
Dr. Fuchs was appointed Chief Executive Officer of
IntraBiotics on January 27, 2003. All other compensation in
2004 is made up of payments made as a member of the Board of
Directors ($10,000) and payments for life insurance made by the
Company on behalf of Mr. Fuchs ($808). |
|
(2) |
Ms. Stafford, has served, and is currently serving, as a
financial consultant for the Company since February 2004.
Ms. Stafford was appointed Principal Financial Officer on
November 12, 2004. Securities underlying options during
2004 includes an option grant to
purchase 12,000 shares of common stock which was
cancelled in part. At the time of the cancellation
Ms. Stafford retained her right to exercise the option for
6,000 shares of common stock, in which she was already
vested. |
|
(3) |
Mr. Ketchum was appointed an officer and Senior Vice
President of Operations & Regulatory Affairs of
IntraBiotics on May 7, 2004. Prior to his appointment
Mr. Ketchum had served as the Companys Vice President
of Regulatory Affairs since June 2002. |
|
(4) |
Mr. Albrecht was appointed Sr. Vice President, Pre-Clinical
and Clinical Research and Development and Chief Medical Officer
on April 12, 2004 and was terminated, as part of a
restructuring, on September 30, 2004. Bonus of $50,000
represents a bonus paid in order to induce Mr. Albrecht to
join the Company. All other compensation during 2004 is made up
severance payments ($206,250) and accrued |
50
|
|
|
vacation ($9,700), paid to Mr. Albrecht, and life insurance
premiums ($694) and continued health care coverage costs
($5,737), paid by the Company on behalf of Mr. Albrecht. |
|
|
(5) |
Mr. Tucker was appointed Principal Financial Officer on
January 5, 2004 and was terminated as part of a
restructuring on November 15, 2004. Prior to his
appointment Mr. Tucker had served as the Companys
Senior Director of Finance since April 2003. All other
compensation during 2004 is made up severance payments
($126,000) and accrued vacation ($6,435), paid to
Mr. Tucker, and life insurance premiums ($296) and
continued health care coverage costs ($3,701), paid by the
Company on behalf of Mr. Tucker. |
Option Grants in Last Fiscal Year
The following table shows for the fiscal year ended
December 31, 2004, certain information regarding options
granted to the Named Executive Officers.
All options have a maximum term of 10 years measured from
the grant date, subject to earlier termination upon the
optionees cessation of service. The exercise price per
share of each option is equal to the fair market value per share
of the common stock on the date immediately preceding the grant
date. Each option will become exercisable in 48 successive equal
monthly installments upon completion of each month of service
over the 48 month period measured from the grant date. The
percent of total options granted to employees during the fiscal
year ending December 31, 2004 is based on
762,416 shares of common stock that were granted to
employees in the fiscal year ended December 31, 2004. The
potential realizable value is calculated based on the term of
the option on the date of grant. It is calculated by assuming
that the stock price on the date of grant appreciates at the
indicated annual rate, compounded annually for the entire term
of the option and that the option is exercised and sold on the
last day of its term for the appreciated stock price. However,
no gain will actually be realized by the option holder unless
the market price of the underlying option shares increases over
the option term. The 5% and 10% assumed rates of appreciation
are derived from the rules of the SEC and do not represent
IntraBiotics estimate or projection of the future common
stock price.
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|
|
Individual Grants | |
|
Potential Realizable | |
|
|
| |
|
Value at Assumed Annual | |
|
|
Number of | |
|
Percent of | |
|
|
|
Rates of Stock Price | |
|
|
Securities | |
|
Total Options | |
|
|
|
Appreciation for Option | |
|
|
Underlying | |
|
Granted to | |
|
|
|
Term ($) | |
|
|
Options | |
|
Employees in | |
|
Exercise | |
|
Expiration | |
|
| |
Name |
|
Granted | |
|
Fiscal Year | |
|
Price ($/Sh) | |
|
Date | |
|
5% | |
|
10% | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Henry J. Fuchs, M.D.
|
|
|
60,000 |
|
|
|
7.9 |
% |
|
|
16.49 |
|
|
|
2/2/14 |
|
|
|
622,228 |
|
|
|
1,576,849 |
|
|
|
|
100,000 |
|
|
|
13.1 |
% |
|
|
13.06 |
|
|
|
5/7/14 |
|
|
|
821,336 |
|
|
|
2,081,428 |
|
Kathleen A. Stafford(1)
|
|
|
12,000 |
|
|
|
1.6 |
% |
|
|
16.49 |
|
|
|
2/2/14 |
|
|
|
9,007 |
|
|
|
17,977 |
|
|
|
|
10,000 |
|
|
|
1.3 |
% |
|
|
13.35 |
|
|
|
5/3/14 |
|
|
|
83,957 |
|
|
|
212,765 |
|
Steven B. Ketchum, Ph. D.
|
|
|
50,000 |
|
|
|
6.6 |
% |
|
|
16.10 |
|
|
|
1/1/14 |
|
|
|
506,260 |
|
|
|
1,282,963 |
|
|
|
|
20,000 |
|
|
|
2.6 |
% |
|
|
13.06 |
|
|
|
5/7/14 |
|
|
|
164,267 |
|
|
|
416,286 |
|
Detlef Albrecht, M.D.(2)
|
|
|
210,000 |
|
|
|
27.6 |
% |
|
|
17.45 |
|
|
|
4/12/14 |
|
|
|
2,304,584 |
|
|
|
5,840,269 |
|
David J. Tucker(3)
|
|
|
10,500 |
|
|
|
1.4 |
% |
|
|
16.10 |
|
|
|
1/1/14 |
|
|
|
106,315 |
|
|
|
269,422 |
|
|
|
|
30,000 |
|
|
|
3.9 |
% |
|
|
13.06 |
|
|
|
5/7/14 |
|
|
|
246,401 |
|
|
|
624,428 |
|
|
|
(1) |
Ms. Staffords option grant to
purchase 12,000 shares of common stock was cancelled
in part. At the time of the cancellation Ms. Stafford
retained her right to exercise the option for 6,000 shares
of common stock, in which she was already vested. |
|
(2) |
In connection with Mr. Albrechts termination of
employment on September 30, 2004 all of the option shares
subject to his option terminated and ceased to be outstanding.
Mr. Albrecht was not vested in any of the shares subject to
option grants on the date of his termination. |
|
(3) |
In connection with Mr. Tuckers termination of
employment on November 15, 2004 all of the option
shares subject to his option grants made during 2004 terminated
and ceased to be outstanding. |
51
Aggregated Option Exercises in Last Fiscal Year and
Fiscal Year-End Option Values
The following table sets forth as to the Named Executive
Officers, information concerning options held as of
December 31, 2004 and exercised during the fiscal year
ended December 31, 2004. No stock appreciation rights were
exercised during the 2004 fiscal year, and none of the Named
Executive Officers held any stock appreciation rights at the end
of that year.
|
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|
Number of | |
|
|
|
|
|
|
|
|
Securities Underlying | |
|
Value of Unexercised | |
|
|
|
|
|
|
Unexercised Options at | |
|
In-the-Money Options at | |
|
|
Shares | |
|
|
|
December 31, 2004 | |
|
December 31, 2004(1) ($) | |
|
|
Acquired on | |
|
Value | |
|
| |
|
| |
Name |
|
Exercise | |
|
Realized ($) | |
|
Exercisable | |
|
Unexercisable | |
|
Exercisable | |
|
Unexercisable | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Henry J. Fuchs, M.D.
|
|
|
|
|
|
|
|
|
|
|
127,075 |
|
|
|
241,258 |
|
|
|
134,989 |
|
|
|
143,010 |
|
Kathleen A. Stafford
|
|
|
|
|
|
|
|
|
|
|
11,833 |
|
|
|
4,167 |
|
|
|
|
|
|
|
|
|
Steven B. Ketchum, Ph. D.
|
|
|
|
|
|
|
|
|
|
|
71,664 |
|
|
|
123,336 |
|
|
|
75,623 |
|
|
|
89,377 |
|
Detlef Albrecht, M.D.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David J. Tucker
|
|
|
|
|
|
|
|
|
|
|
14,248 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Based on the market price of $4.08 per share, determined on
the basis of the closing selling price per share of common stock
on the NASDAQ National Market on December 31, 2004 less the
option exercise price per share. |
Employment Contracts and Termination of Employment and
Change-in-Control Arrangements
In June 2001, the Board adopted a Senior Executive Severance
Benefit Plan for the benefit of IntraBiotics executive
officers which was amended and restated effective August 1,
2002. Under this plan, in the event of a constructive
termination or an involuntary termination without cause of an
executive officer, other than the Chief Executive Officer, such
executive officer is entitled to receive a lump sum payment
equal to 9 times his or her monthly rate of base salary, plus a
payment equal to his or her monthly base salary multiplied by
the number of years of completed service performed in excess of
two, up to a maximum of 15. In addition, such executive officer
is entitled to continue to receive health benefits for a period
of 9 months plus one month of additional health benefits
for each completed year of service performed in excess of two
years of service, up to a maximum of 15 months. In the
event of a constructive termination or an involuntary
termination without cause of the Chief Executive Officer, such
Chief Executive Officer is entitled to receive a lump sum
payment equal to 12 times his or her monthly rate of base
salary, plus a payment equal to his or her monthly base salary
multiplied by the number of years of completed service performed
in excess of two, up to a maximum of 20. In addition, the Chief
Executive Officer is entitled to continue to receive health
benefits for a period of 12 months plus one month of
additional salary for each complete year of service performed in
excess of two years of service, up to a maximum of
20 months. Pursuant to this program, Mr. Tucker and
Mr. Albrecht received lump sum severance payments in the
amount of $126,000 and $206,250, respectively, and they may
receive continued health coverage at IntraBiotics expense
for a 9 month period, following termination of their
employment.
Pursuant to IntraBiotics 1995 Stock Option Plan, the 2000
Equity Incentive Plan and the 2004 Stock Incentive Plan, in the
event of a sale or disposition of substantially all of the
securities or assets of IntraBiotics, a merger of IntraBiotics
with or into another corporation or a consolidation or other
change of control transaction involving IntraBiotics, the stock
awards held by our executive officers will vest and become
immediately exercisable as to half of the otherwise unvested
shares underlying those awards, and any remaining unvested
shares underlying those stock awards will vest in full should
either of the following events occur within 13 months after
the transaction: the executive officers employment is
involuntarily terminated without cause or he or she voluntarily
resigns for good reason.
IntraBiotics and Ms. Stafford entered into a consulting
agreement dated February 2, 2004 pursuant to which
Ms. Stafford received a fee of $15,000 per month for
her performance of up to twenty-five (25) hours of
52
consulting services per week. On May 1, 2004 IntraBiotics
and Ms. Stafford entered into a consulting agreement, which
replaced the previous agreement, pursuant to which
Ms. Stafford received a fee of $12,000 per month for
her performance of up to twenty (20) hours of consulting
services per week. On September 1, 2004 IntraBiotics and
Ms. Stafford entered into a consulting agreement, which
replaced the previous agreement, pursuant to which
Ms. Stafford received a fee of $15,000 per month. On
January 1, 2005 IntraBiotics and Ms. Stafford entered
into a consulting agreement, which replaced the previous
agreement, pursuant to which Ms. Stafford received a fee of
$10,000 per month.
Compensation Committee Interlocks and Insider
Participation.
IntraBiotics Compensation Committee currently consists of
Mr. Lyons, Mr. Perry and Mr. Jackson. No member
of this committee has at any time been an officer or employee of
IntraBiotics. None of our executive officers serves as a member
of the Board or compensation committee of any entity that has
one or more executive officers serving as a member of our Board
or Compensation Committee.
|
|
Item 12. |
Security Ownership of Certain Beneficial Owners and
Management |
The following table sets forth certain information regarding the
ownership of IntraBiotics common stock as of
February 28, 2005 by: (i) each director;
(ii) each of the named executive officers; (iii) all
executive officers and directors of IntraBiotics as a group; and
(iv) all those known by IntraBiotics to be beneficial
owners of more than five percent of its common stock. All
capital stock numbers disclosed below are adjusted to reflect
the 1-for-12 reverse stock split effected on April 10, 2003.
|
|
|
|
|
|
|
|
|
|
|
|
Beneficial Ownership(1) | |
|
|
| |
|
|
Number of | |
|
Percent of | |
Name and Address of Beneficial Owner |
|
Shares | |
|
Total | |
|
|
| |
|
| |
Entities affiliated with Baker Biotech Funds(2)
|
|
|
2,109,286 |
|
|
|
23.3 |
% |
|
655 Madison Avenue, 19th Floor
|
|
|
|
|
|
|
|
|
|
New York, NY 10021
|
|
|
|
|
|
|
|
|
Entities affiliated with Perry Corp(3)
|
|
|
1,710,530 |
|
|
|
18.9 |
% |
|
599 Lexington Ave., 36th Floor
|
|
|
|
|
|
|
|
|
|
New York, NY 10022
|
|
|
|
|
|
|
|
|
Entities affiliated with Tang Capital Partners(4)
|
|
|
1,666,831 |
|
|
|
18.4 |
% |
|
4401 Eastgate Mall
|
|
|
|
|
|
|
|
|
|
San Diego, CA 92121
|
|
|
|
|
|
|
|
|
Deutsche Bank AG(5)
|
|
|
912,916 |
|
|
|
10.1 |
% |
|
Taunusanlage 12, D-60325
|
|
|
|
|
|
|
|
|
|
Frankfurt am Main
|
|
|
|
|
|
|
|
|
|
Federal Republic of Germany
|
|
|
|
|
|
|
|
|
Ernest Mario, Ph.D.(6)
|
|
|
242,410 |
|
|
|
2.7 |
% |
Henry J. Fuchs, M.D.(7)
|
|
|
159,251 |
|
|
|
1.8 |
% |
Jerry T. Jackson(8)
|
|
|
28,749 |
|
|
|
* |
|
Gary A. Lyons(9)
|
|
|
31,665 |
|
|
|
* |
|
Mark L. Perry, J.D.(10)
|
|
|
17,500 |
|
|
|
* |
|
Jack S. Remington, M.D.(11)
|
|
|
22,583 |
|
|
|
* |
|
Kevin C. Tang(3)
|
|
|
1,666,831 |
|
|
|
18.4 |
% |
Steven B. Ketchum, Ph. D(12)
|
|
|
87,913 |
|
|
|
* |
|
Kathleen A. Stafford(13)
|
|
|
15,166 |
|
|
|
* |
|
Detlef Albrecht, M.D.
|
|
|
|
|
|
|
* |
|
David J. Tucker
|
|
|
|
|
|
|
* |
|
All executive officers and directors as a group (9 persons)(14)
|
|
|
2,266,068 |
|
|
|
25.0 |
% |
53
|
|
|
|
* |
Less than one percent of the outstanding common shares. |
|
|
(1) |
This table is based upon information supplied by officers,
directors and principal stockholders. Unless otherwise indicated
in the footnotes to this table and subject to community property
laws where applicable, IntraBiotics believes that each of the
stockholders named in this table has sole voting and investment
power with respect to the shares indicated as beneficially
owned. Unless otherwise indicated, the principal address of each
of the stockholders named in this table is:
c/o IntraBiotics Pharmaceuticals, Inc., 2483 East Bayshore
Road, Suite 100, Palo Alto, CA 94303. Applicable
percentages are based on 9,067,645 shares outstanding on
February 28, 2005. Shares of common stock that (a) may
be issued upon the conversion of Series A preferred stock,
(b) may be issued upon the exercise of warrants and
(c) are subject to options to purchase common stock which
are currently exercisable or which will become exercisable
within 60 days after February 28, 2005 are deemed
outstanding for computing the percentage of the person or group
holding such options, but are not deemed outstanding for
computing the percentage of any other person or group. |
|
(2) |
Includes 82,559 shares held by Baker Brothers Investments,
L.P., 97,366 shares held by Baker Brothers Investments II,
L.P., 68,932 shares held by Baker/ Tisch Investments, L.P.,
888,313 shares held by Baker Biotech Fund I, L.P.,
864,199 shares held by Baker Biotech Fund II, L.P. and
107,917 shares held by Baker Biotech Fund II (Z), L.P.
Also includes 726,038 shares of common stock that may be
issued upon the conversion of Series A preferred stock and
436,617 shares of commons stock that may be issued upon the
exercise of warrants. |
|
(3) |
Pursuant to a Schedule 13G/ A filed on February 10,
2005 with the Securities and Exchange Commission, Perry Corp.
and Richard Perry jointly reported that it had sole voting power
and sole dispositive power over 1,710,530 shares of common
stock. Richard Perry, the President and sole stockholder of
Perry Corp., disclaimed beneficial ownership interest over of
the shares of common stock held by any funds for which Perry
Corp. acts as the general partner and/or investment adviser,
except for that portion of such shares that relates to his
economic interest in such shares. |
|
(4) |
Includes 351,842 shares held by Tang Capital Partners, L.P.
Tang Capital Management, LLC is the general partner of Tang
Capital Partners, L.P. and Kevin C. Tang is the Managing
Director of Tang Capital Management, LLC. Includes
583 shares held by Kevin C. Tang as custodian for his minor
child. Also includes 852,308 shares of common stock that
may be issued upon the conversion of Series A preferred
stock and 450,154 shares of common stock that may be issued
upon the exercise of warrants. Also includes 11,944 shares
of common stock issuable upon exercise of options owned by
Mr. Tang that are exercisable or will become exercisable
within 60 days of February 28, 2005. As a result of
being a director of IntraBiotics Mr. Tang is deemed to
beneficially own the shares owned by Tang Capital Partners, L.P. |
|
(5) |
Pursuant to a Schedule 13G filed on January 31, 2005
with the Securities and Exchange Commission, Deutsche Bank AG
reported that it had sole voting power and sole dispositive
power over 912,916 shares of common stock. |
|
(6) |
Includes 20,833 shares held by Mildred Mario,
20,573 shares held by the Ernest Mario 1997 Annuity Trust,
41,666 shares held by the Mildred Mario 1997 Annuity Trust,
and 744 shares and 1,738 shares held by the Mario 2002
Childrens Trust and the Mario 2002 Grandchildrens
Trust, respectively, for both of which Dr. Mario is
trustee. Also includes 86,421 shares issuable upon exercise
of options that are exercisable or will become exercisable
within 60 days of February 28, 2005. |
|
(7) |
Includes 157,076 shares issuable upon exercise of options
that are exercisable or will become exercisable within
60 days of February 28, 2005. |
|
(8) |
Represents 28,749 shares issuable upon exercise of options
that are exercisable or will become exercisable within
60 days of February 28, 2005. |
|
(9) |
Represents 31,665 shares issuable upon exercise of options
that are exercisable or will become exercisable within
60 days of February 28, 2005. |
54
|
|
(10) |
Represents 17,500 shares issuable upon exercise of options
that are exercisable or will become exercisable within
60 days of February 28, 2005. Mr. Perry is not
affiliated with Perry Partners & Affiliates. |
|
(11) |
Includes 22,500 shares issuable upon exercise of options
that are exercisable or will become exercisable within
60 days of February 28, 2005. |
|
(12) |
Represents 87,913 shares issuable upon exercise of options
that are exercisable or will become exercisable within
60 days of February 28, 2005. |
|
(13) |
Includes 9,166 shares issuable upon exercise of options
that are exercisable or will become exercisable within
60 days of February 28, 2005. |
|
(14) |
Includes 1,654,887 shares of common stock held by entities
affiliated with certain directors and 452,934 shares of
common stock issuable upon exercise of stock options held by
directors and executive officers that are exercisable within
60 days of February 28, 2005. |
Equity Compensation Plan Information
The following table provides certain information with respect to
all equity compensation plans in effect as of December 31,
2004.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of | |
|
|
|
|
|
|
Securities | |
|
|
|
|
|
|
Remaining | |
|
|
|
|
|
|
Available for | |
|
|
Number of | |
|
Weighted- | |
|
Issuance under | |
|
|
Securities to Be | |
|
Average Exercise | |
|
Equity | |
|
|
Issued upon | |
|
Price of | |
|
Compensation | |
|
|
Exercise of | |
|
Outstanding | |
|
Plans (Excluding | |
|
|
Outstanding | |
|
Options, | |
|
Securities | |
|
|
Options, Warrants | |
|
Warrants and | |
|
Reflected in | |
|
|
and Rights (a) | |
|
Rights (b) | |
|
Column (a)) (c) | |
|
|
| |
|
| |
|
| |
Equity compensation plans approved by security holders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amended and Restated 1995 Stock Option Plan(1)
|
|
|
8,333 |
|
|
$ |
2.40 |
|
|
|
|
|
|
2000 Employee Stock Purchase Plan(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 Stock Incentive Plan
|
|
|
1,047,968 |
|
|
$ |
8.94 |
|
|
|
1,008,648 |
(3) |
Equity compensation plans not approved by security holders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2002 Non-Officer Equity Incentive Plan
|
|
|
105,432 |
|
|
$ |
4.70 |
|
|
|
53,764 |
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
1,161,733 |
|
|
$ |
8.51 |
|
|
|
1,062,412 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
No new stock awards may be granted under the Amended and
Restated 1995 Stock Option Plan. |
|
(2) |
Generally, on each December 31, the 2000 Employee Stock
Purchase Plan share reserve will increase automatically by the
lesser of (i) 1% of the outstanding Common Stock,
(ii) 41,666 shares, or (iii) a lesser amount
determined by the Board. However, this plan was suspended in
March 2003, and consequently there are currently no securities
reserved for issuance under this plan. |
|
(3) |
The number of shares of common stock reserved for issuance under
the 2004 Stock Incentive Plan will automatically increase on the
first trading day in January each calendar year, beginning in
calendar year 2005, by an amount equal to five percent of the
sum of the following share numbers, calculated as of the last
trading day in December of the immediately preceding calendar
year: (i) the total number of shares of our common stock
outstanding on that date and (ii) the number of shares of
common stock into which the outstanding shares of our preferred
stock are convertible on that date. In no event will any such
annual increase exceed 2,000,000 shares. Accordingly, the
number of shares available for issuance increased by 529,510
from the number shown in the table above, on January 3,
2005. |
55
The following is a brief summary of material features of the
2002 Non-Officer Equity Incentive Plan, which was adopted
without stockholder approval:
2002 Non-Officer Equity Incentive Plan
General. IntraBiotics 2002 Non-Officer Equity
Incentive Plan (the Non-Officer Equity
Plan) provides for stock awards, including grants
of nonstatutory stock options, stock bonuses or rights to
acquire restricted stock, to employees and consultants who are
not executive officers of IntraBiotics. Executive officers not
previously employed by IntraBiotics may also be granted stock
awards. An aggregate of 208,333 shares of common stock have
been authorized for issuance under the Non-Officer Equity Plan.
As of December 31, 2004, options to
purchase 105,432 shares to purchase common stock were
outstanding and options to purchase 53,764 shares of
common stock remained available for future grant. Options to
purchase 49,137 shares of common stock have been
exercised since inception of the plan. The exercise price per
share of options granted under the Non-Officer Equity Plan may
not be less than 85% of the fair market value of
IntraBiotics common stock on the date of the grant.
Options granted under the Non-Officer Equity Plan have a maximum
term of ten years and typically vest over a four-year period.
Options may be exercised prior to vesting, subject to repurchase
rights in favor of IntraBiotics that expire over the vesting
period. Shares issued under a stock bonus award may be issued in
exchange for past services performed for IntraBiotics and may be
subject to vesting and a share repurchase option in favor of
IntraBiotics. Shares issued pursuant to restricted stock awards
may not be purchased for less than 85% of the fair market value
of IntraBiotics common stock on the date of grant. Shares
issued pursuant to restricted stock awards may be subject to
vesting and a repurchase option in IntraBiotics favor.
Adjustment Provisions. Transactions not involving receipt
of consideration by IntraBiotics, such as a merger,
consolidation, reorganization, stock dividend, or stock split,
may change the type(s), class(es) and number of shares of common
stock subject to the Non-Officer Equity Plan and outstanding
awards. In that event, the Non-Officer Equity Plan will be
appropriately adjusted as to the type(s), class(es) and the
maximum number of shares of common stock subject to the
Non-Officer Equity Plan, and outstanding awards will be adjusted
as to the type(s), class(es), number of shares and price per
share of common stock subject to such awards.
Effect of Certain Corporate Transactions. In the event of
(i) the sale, lease or other disposition of all or
substantially all of the assets of IntraBiotics, (ii) a
merger, consolidation or similar transactions in which
IntraBiotics pre-corporate transaction stockholders do not
hold securities representing a majority of voting power in the
surviving corporation, or (iii) an acquisition, other than
by virtue of a merger, consolidation or similar transaction, by
any person, entity or group of securities of IntraBiotics
representing at least fifty percent (50%) of the combined voting
power of IntraBiotics then outstanding securities (each, a
corporate transaction), the surviving or acquiring
corporation may continue or assume awards outstanding under the
Non-Officer Equity Plan or may substitute similar awards.
If any surviving or acquiring corporation does not assume such
awards or substitute similar awards, then with respect to awards
held by participants whose service with IntraBiotics has not
terminated as of the effective date of the transaction, the
vesting of such awards will be accelerated in full, any
reacquisition or repurchase rights held by IntraBiotics shall
lapse, and the awards will terminate if not exercised (if
applicable) at or prior to such effective date. With respect to
any other awards, the vesting of such awards will not accelerate
and the awards will terminate if not exercised (if applicable)
at or prior to such effective date.
However, the following special vesting acceleration provisions
will be in effect for all corporate transactions in which the
outstanding options under the plan are to be assumed or
replaced: (i) the awards held by employees will vest and
become immediately exercisable as to half of the otherwise
unvested shares underlying those awards, (ii) the awards
held by executives (vice president or higher) will vest with
respect to the remaining unvested shares underlying those awards
should either of the following events occur within
13 months after the transaction: the executives
employment is involuntarily terminated without cause (as defined
in the Non-Officer Equity Plan) or the executive voluntarily
resigns for good reason (as defined in the
56
Non-Officer Equity Plan) and (iii) the awards held by
non-employee Board members will vest and become immediately
exercisable as to all shares underlying the award.
|
|
Item 13. |
Certain Relationships and Related Party
Transactions |
We have entered into indemnification agreements with our
officers and directors which provide, among other things, that
we will indemnify such officer or director, under the
circumstances and to the extent provided for therein, for
expenses, damages, judgments, fines and settlements he or she
may be required to pay in actions or proceedings which he or she
is or may be made a party by reason of his or her position as a
director, officer or other agent of IntraBiotics, and otherwise
to the fullest extent permitted under Delaware law and
IntraBiotics bylaws.
|
|
Item 14. |
Principal Accountant Fees and Services |
Auditors Fees
During the fiscal year ended December 31, 2004, the Audit
Committee reviewed and approved all audit and non-audit service
engagements, after giving consideration as to whether the
provision of such services was compatible with maintaining
Ernst & Young LLPs and Stonefield Josephson
Inc.s independence.
The following table shows the fees billed and billable for the
audit and other services provided by Ernst & Young LLP
and Stonefield Josephson, Inc. for fiscal years 2004 and 2003.
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Ernst & Young LLP:
|
|
|
|
|
|
|
|
|
|
Audit fees(a)
|
|
$ |
157,500 |
|
|
$ |
298,200 |
|
|
Audit-related fees(b)
|
|
|
2,100 |
|
|
|
1,140 |
|
|
Tax fees(c)
|
|
|
30,413 |
|
|
|
23,820 |
|
|
All other fees(d)
|
|
|
|
|
|
|
|
|
Stonefield Josephson, Inc.:
|
|
|
|
|
|
|
|
|
|
Audit fees(a)
|
|
|
85,000 |
|
|
|
|
|
|
Audit-related fees(b)
|
|
|
10,000 |
|
|
|
|
|
|
Tax fees(c)
|
|
|
19,000 |
|
|
|
|
|
|
All other fees(d)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
304,013 |
|
|
$ |
323,160 |
|
|
|
|
|
|
|
|
|
|
(a) |
Audit Fees. Includes fees for the audit of our annual financial
statements included on Form 10-K, review of interim
financial statements included on Forms 10-Q, review of
documents filed with the SEC and the issuance of consents and
comfort letters. |
|
|
|
(b) |
|
Audit-Related Fees. Includes fees for accounting consultations,
due diligence assistance related to mergers and acquisitions and
an annual subscription to online accounting updates. |
|
(c) |
|
Tax Fees. Includes fees for tax compliance, tax advice and tax
planning. |
|
(d) |
|
All Other Fees. Includes all other fees for products and
services other than the services included in (a)-(c) above. |
Policy on Audit Committee Pre-Approval of Audit and Non-Audit
Services of Independent Auditors
The Audit Committees policies and procedures identify
particular services and related pre-approved limits for each
service that it has concluded the independent auditors may
provide. These policies and procedures will be updated each year
in connection with the Audit Committees determination to
retain the independent auditors. To the extent that a proposed
service is not identified in these policies, the Audit Committee
must either approve the service in advance of it being provided
to IntraBiotics or the Chairman of
57
the Audit Committee may approve the service at an indicated
monetary limit for the service or delegate such approval
authority to another member of the Audit Committee. If the
Chairman of the Audit Committee or the delegated member of the
Audit Committee approves any service in accordance with this
authorization, the Chairman or such member of the Audit
Committee, as applicable, must report the approval of the
service to the Audit Committee at its next regularly scheduled
meeting. The independent auditors and management are required to
periodically report to the Audit Committee regarding the extent
of services provided by the independent auditors in accordance
with this pre-approval, and the fees for he services performed
to date. The Audit Committee may also pre-approve particular
services on a case-by-case basis.
PART IV
|
|
Item 15. |
Exhibits and Financial Statement Schedules |
(a) 1. Financial
Statements
The Financial Statements and Report of Independent Auditors are
included in a separate section of this Annual Report on
Form 10-K. See index to Financial Statements at Item 8
of this Form 10-K.
2. Financial Statement
Schedules
All financial statement schedules are omitted because they were
not required or the required information is included in the
Financial Statements and the related notes. See index to
consolidated financial statements at Item 8 of this Annual
Report on Form 10-K.
3. Exhibit Index
See Exhibit Index on page 60 of this Annual Report on
Form 10-K.
(b) Exhibits
See Exhibit Index on page 60 of this Annual Report on
Form 10-K.
(c) Financial Statement Schedules
See (a)(2) above.
58
SIGNATURES
Pursuant to the requirements of Section 13 or 15
(d) of the Securities Exchange Act of 1934, the Registrant
has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized on this 10th day of March
2005.
|
|
|
Intrabiotics
Pharmaceuticals, Inc.
|
|
|
|
|
By |
/s/ Henry J.
Fuchs, M.D.
|
|
|
|
|
|
Henry J. Fuchs, M.D. |
|
President and Chief Executive Officer |
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose
signature appears below constitutes and appoints, jointly and
severally, Henry J. Fuchs, M.D. his attorney in fact, with
the full power of substitution, for such person, in any and all
capacities, to sign any and all amendments to this Annual Report
on Form 10-K, and to file the same, with all exhibits
thereto and other documents in connection therewith, with the
Securities and Exchange Commission, granting unto said
attorney-in-fact and agent full power and authority to do and
perform each and every act and thing requisite and necessary to
be done in connection therewith, as fully to all intents and
purposes as he might do or could do in person hereby ratifying
and confirming all that said attorney-in-fact and agents, or his
substitute, may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of
1934, this report has been signed below by the following persons
on behalf of the Registrant in the capacities and on the dates
indicated.
|
|
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
|
/s/ Henry J. Fuchs
Henry
J. Fuchs, M.D. |
|
President and Chief Executive Officer |
|
March 10, 2005 |
|
/s/ Kathleen A.
Stafford
Kathleen
A. Stafford |
|
Principal Financial Officer |
|
March 10, 2005 |
|
/s/ Ernest Mario
Ernest
Mario, Ph.D. |
|
Chairman of the Board |
|
March 10, 2005 |
|
/s/ Kevin C. Tang
Kevin
C. Tang |
|
Director |
|
March 10, 2005 |
|
/s/ Mark L. Perry
Mark
L. Perry |
|
Director |
|
March 10, 2005 |
|
/s/ Gary A. Lyons
Gary
A. Lyons |
|
Director |
|
March 10, 2005 |
|
/s/ Jerry Jackson
Jerry
Jackson |
|
Director |
|
March 10, 2005 |
|
/s/ Jack S. Remington
Jack
S. Remington |
|
Director |
|
March 10, 2005 |
59
EXHIBIT INDEX
|
|
|
|
|
|
3 |
.1 |
|
Certificate of Amendment of Amended and Restated Certificate of
Incorporation; and Amended and Restated Certificate of
Incorporation.(12) |
|
3 |
.2 |
|
Amended and Restated Bylaws(16) |
|
3 |
.3 |
|
Certificate of Amendment to Amended and Restated Certificate of
Incorporation.(15) |
|
3 |
.4 |
|
Certificate of Designation filed with the Delaware Secretary of
State on May 1, 2003.(15) |
|
4 |
.1 |
|
Amended and Restated Investor Rights Agreement dated
October 15, 1999.(1) |
|
4 |
.2 |
|
Form of Stock Purchase Agreement by and between the Company and
each selling stockholder, dated January 29, 2002.(3) |
|
4 |
.3 |
|
Form of Preferred Stock and Warrant Purchase Agreement, dated
February 5, 2003, as amended on February 11, 2003.(8) |
|
4 |
.4 |
|
Form of Second Amendment to Preferred Stock and Warrant Purchase
Agreement of February 5, 2003, dated April 10,
2003.(10) |
|
4 |
.5 |
|
Form of Warrant issued by the Company pursuant to Preferred
Stock and Warrant Purchase Agreement of February 5, 2003,
as amended of February 11, 2003 and April 10, 2003.(10) |
|
4 |
.6 |
|
Form of Common Stock and Warrant Purchase Agreement, dated
October 6, 2003.(11) |
|
4 |
.7 |
|
Form of Warrant issued by the Company pursuant to the Common
Stock and Warrant Purchase Agreement of October 6, 2003.(11) |
|
10 |
.1 |
|
Form of Indemnity Agreement.(1) |
|
10 |
.2 |
|
Amended and Restated 1995 Stock Option Plan, as amended on
November 16, 2002.(7)(9) |
|
10 |
.2.2 |
|
Amended and Restated Form of Stock Option Agreement and Notice
of Grant of Stock Options and Option Agreement.(1)(7) |
|
10 |
.3 |
|
2000 Equity Incentive Plan, as amended on February 11,
2003.(7)(9) |
|
10 |
.9 |
|
2000 Employee Stock Purchase Plan and related documents.(1)(7) |
|
10 |
.15 |
|
Senior Executive Severance Benefit Plan, as amended and restated
on August 1, 2002.(5)(7) |
|
10 |
.16 |
|
Executive Severance Benefit Plan, as amended and restated on
August 1, 2002.(5)(7) |
|
10 |
.17 |
|
Summary of Officer Incentive Bonus Plan.(2)(7) |
|
10 |
.18 |
|
Release Agreement by and between the Company and Diversa
Corporation dated July 27, 2001, including Warrant to
Purchase Common Stock of the Company and Registration Rights
Agreement.(4) |
|
10 |
.22 |
|
2002 Non-Officer Equity Incentive Plan and related documents, as
amended on February 3, 2003.(9) |
|
10 |
.24 |
|
Lease Termination Agreement by and between the Company and
EOP-Shoreline Technology Park, L.L.C., dated November 22,
2002, including Common Stock Purchase Agreement.(6) |
|
10 |
.27 |
|
Amendment and Assignment of Lease, Release and Assumption
Agreement by and among the Company, PolyFuel, Inc. and 1245
Terra Bella Partners, LLC, dated December 20, 2002,
including Warrant to Purchase Common Stock of the Company dated
December 31, 2002.(9) |
|
10 |
.29 |
|
Lease Agreement by and between the Company and Embarcadero
Corporate Center, dated February 10, 2003.(9) |
|
10 |
.30 |
|
Common Stock and Warrant Purchase Agreement, dated
October 6, 2003 (the Purchase Agreement) by and
among the Company and each Investor as defined therein.(11) |
|
10 |
.31 |
|
Form of warrant issued by the Company in favor of each Investor,
as defined in the Purchase Agreement.(11) |
|
10 |
.32 |
|
2004 Stock Incentive Plan.(13) |
|
10 |
.33 |
|
First Amendment to Office Lease, dated March 11, 2004,
between the Company and Embarcadero Corporate Center.(13) |
60
|
|
|
|
|
|
10 |
.34 |
|
Consulting agreement between the Company and Kathleen A.
Stafford the Companys Principal Financial Officer.* |
|
16 |
.1 |
|
Letter regarding Change in Certifying Accountants.(14) |
|
23 |
.1 |
|
Consent of Stonefield Josephson, Inc., Independent Registered
Public Accounting Firm.* |
|
23 |
.2 |
|
Consent of Ernst & Young LLP, Independent Registered
Public Accounting Firm.* |
|
24 |
.1 |
|
Power of Attorney. Reference is made to the signature page. |
|
31 |
.1 |
|
Certification of Chief Executive Officer pursuant to
Rules 13a-14(a) or 15d-14(a) promulgated under the
Securities Exchange Act of 1934, as amended.* |
|
31 |
.2 |
|
Certification of Principal Financial Officer pursuant to
Rules 13a-14(a) or 15d-14(a) promulgated under the
Securities Exchange Act of 1934, as amended.* |
|
32 |
.1 |
|
Certifications of Chief Executive Officer and Principal
Financial Officer as required by Rule 13a-14(b) or Rule
15d-14(b) and Section 1350 of Chapter 63 of
Title 18 of the United States Code (18 U.S.C. 1350).* |
|
|
|
Confidential treatment request has been granted with respect to
certain portions of this exhibit. Omitted portions have been
filed separately with the Securities and Exchange Commission. |
|
|
(1) |
Incorporated by reference to exhibit to our Registration
Statement on Form S-1 (File No. 333-95461) initially
filed with the Securities and Exchange Commission on
January 27, 2000 as subsequently amended. |
|
(2) |
Incorporated by reference to exhibit to our Form 10-Q (File
No. 000-29993) filed with the Securities and Exchange Commission
on August 14, 2001. |
|
(3) |
Incorporated by reference to exhibit to our Registration
Statement on Form S-3 (File No. 333-82934) filed with
the Securities and Exchange Commission on February 15, 2002. |
|
(4) |
Incorporated by reference to exhibit to our Registration
Statement on Form S-3 (File No. 333-89840) filed with
the Securities and Exchange Commission on June 5, 2002. |
|
(5) |
Incorporated by reference to exhibit to our Form 10-Q (File
No. 000-29993) filed with the Securities and Exchange Commission
on November 14, 2002. |
|
(6) |
Incorporated by reference to exhibit to our Form 8-K (File
No. 000-29993) filed with the Securities and Exchange
Commission on November 27, 2002. |
|
(7) |
Management contract or compensatory plan, contract or
arrangement. |
|
(8) |
Incorporated by reference to Appendix B to the Definitive
Proxy Statement for the Special Meeting of Stockholders (File
No. 000-29993) filed with the Securities and Exchange
Commission on March 3, 2003. |
|
(9) |
Incorporated by reference to exhibit to our Form 10-K (File
No. 000-29993) filed with the Securities and Exchange
Commission on March 31, 2003. |
|
|
(10) |
Incorporated by reference to our Form 10-Q (File
No. 000-29993) filed with the Securities and Exchange
Commission on May 14, 2003. |
|
(11) |
Incorporated by reference to exhibit to our Form 8-K (File
No. 000-29993) filed with the Securities and Exchange
Commission on October 9, 2003. |
|
(12) |
Incorporated by reference to our Form 10-Q (File
No. 000-29993) filed with the Securities and Exchange
Commission on November 12, 2003. |
|
(13) |
Incorporated by reference to our Registration Statement on
Form S-1 (File No. 333-114451) initially filed with
the Securities and Exchange Commission on April 14, 2004 as
subsequently amended. |
|
(14) |
Incorporated by reference to our Form 8-K/ A (File
No. 000-29993) filed with the Securities and Exchange
Commission on November 18, 2004. |
61