Filed by Bowne Pure Compliance
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
for the quarterly period ended December 31, 2008
or
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
for the transition period from to .
Commission file number: 001-14907
IMMTECH PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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39-1523370 |
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.) |
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One North End Avenue, New York, New York
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10282 |
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(Address of principal executive offices)
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(Zip Code) |
Registrants telephone number: (212) 791-2911
Former name, former address and former fiscal year, if changed since last report
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 whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
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Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
As of February 2, 2009, 16,966,048 shares of the Registrants common stock, par value $0.01 per
share (Common Stock), were outstanding.
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
IMMTECH PHARMACEUTICALS, INC. AND SUBSIDIARIES
(A Development Stage Enterprise)
CONSOLIDATED BALANCE SHEETS (UNAUDITED)
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December 31, |
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March 31, |
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2008 |
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2008 |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
913,770 |
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$ |
5,996,157 |
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Restricted funds on deposit |
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504,145 |
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3,776,253 |
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Prepaid rent |
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2,000,000 |
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Other receivables |
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|
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54,205 |
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Other current assets |
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162,880 |
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|
253,014 |
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Total current assets |
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3,580,795 |
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10,079,629 |
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PROPERTY AND EQUIPMENT Net |
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59,567 |
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89,519 |
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PREPAID RENT |
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3,234,314 |
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OTHER ASSETS |
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47,731 |
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|
34,142 |
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TOTAL |
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$ |
3,688,093 |
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$ |
13,437,604 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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CURRENT LIABILITIES: |
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Accounts payable |
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$ |
977,877 |
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$ |
2,938,511 |
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Accrued expenses |
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|
317,519 |
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|
499,770 |
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Deferred revenue |
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173,033 |
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2,399,676 |
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Total current liabilities |
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1,468,429 |
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|
5,837,957 |
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Total liabilities |
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1,468,429 |
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5,837,957 |
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-1-
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December 31, |
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March 31, |
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2008 |
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2008 |
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STOCKHOLDERS EQUITY: |
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Preferred stock, par value $0.01 per share, 3,913,000 shares authorized and
unissued as of December 31, 2008 and March 31, 2008. |
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Series A convertible preferred stock, par value $0.01 per share, stated value
$25 per share, 320,000 shares authorized, 32,500 and 50,500 shares issued
and outstanding as of December 31, 2008 and March 31, 2008, respectively;
aggregate liquidation preference of $822,383 as of December 31, 2008. |
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|
822,383 |
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|
1,296,831 |
|
Series B convertible preferred stock, par value $0.01 per share, stated value
$25 per share, 240,000 shares authorized, 9,464 and 11,464 shares issued
and outstanding as of December 31, 2008 and March 31, 2008, respectively;
aggregate liquidation preference of $240,118 as of December 31, 2008. |
|
|
240,118 |
|
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|
296,780 |
|
Series C convertible preferred stock, par value $0.01 per share, stated value
$25 per share, 160,000 shares authorized, 45,536 shares issued and outstanding
as of December 31, 2008 and March 31, 2008; aggregate liquidation preference
of $1,157,889 as of December 31, 2008. |
|
|
1,157,889 |
|
|
|
1,180,345 |
|
Series D convertible preferred stock, par value $0.01 per share, stated value
$25 per share, 200,000 shares authorized, 115,200 shares issued and outstanding
as of December 31, 2008 and March 31, 2008; aggregate liquidation preference
of $2,916,925 as of December 31, 2008. |
|
|
2,916,925 |
|
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|
2,959,533 |
|
Series E convertible preferred stock, par value $0.01 per share, stated value
$25 per share, 167,000 shares authorized, 98,600 shares issued
and outstanding as of March 31, 2008; aggregate liquidation preference of $2,533,107
as of March 31, 2008 (subsequently converted to common stock). |
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|
|
|
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|
2,533,107 |
|
Common stock, par value $0.01 per share, 100,000,000 shares
authorized, 16,966,048 and 15,597,768 shares issued and outstanding
as of December 31, 2008 and March 31, 2008, respectively |
|
|
169,660 |
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155,978 |
|
Additional paid-in capital |
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|
114,414,611 |
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|
110,743,899 |
|
Deficit accumulated during the developmental stage |
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|
(117,501,922 |
) |
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|
(111,566,826 |
) |
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|
|
|
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|
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|
|
|
|
|
|
|
|
Total stockholders equity |
|
|
2,219,664 |
|
|
|
7,599,647 |
|
|
|
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|
|
|
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|
|
|
|
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|
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TOTAL |
|
$ |
3,688,093 |
|
|
$ |
13,437,604 |
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|
|
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|
|
See notes to consolidated financial statements (unaudited).
-2-
IMMTECH PHARMACEUTICALS, INC. AND SUBSIDIARIES
(A Development Stage Enterprise)
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
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October 15, |
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|
|
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|
|
|
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|
1984 |
|
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|
Three Months Ended |
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Nine Months Ended |
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|
(Inception) to |
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December 31, |
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December 31, |
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|
December 31, |
|
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|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
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|
2008 |
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|
|
|
|
|
|
|
|
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|
REVENUES |
|
$ |
562,631 |
|
|
$ |
1,835,399 |
|
|
$ |
2,209,818 |
|
|
$ |
3,692,081 |
|
|
$ |
37,009,814 |
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|
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EXPENSES: |
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Research and development |
|
|
733,548 |
|
|
|
4,213,952 |
|
|
|
3,218,450 |
|
|
|
8,414,603 |
|
|
|
74,902,168 |
|
General and administrative |
|
|
1,211,329 |
|
|
|
2,926,309 |
|
|
|
3,403,980 |
|
|
|
6,857,515 |
|
|
|
76,481,292 |
|
Asset impairment charge |
|
|
503,778 |
|
|
|
|
|
|
|
1,196,851 |
|
|
|
|
|
|
|
1,196,851 |
|
Other (litigation settlement) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,874,454 |
) |
Equity in loss of joint venture |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
135,002 |
|
|
|
|
|
|
|
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|
|
|
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|
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|
|
|
|
|
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|
|
|
|
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|
|
|
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|
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|
Total expenses |
|
|
2,448,655 |
|
|
|
7,140,261 |
|
|
|
7,819,281 |
|
|
|
15,272,118 |
|
|
|
150,840,859 |
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
LOSS FROM OPERATIONS |
|
|
(1,886,024 |
) |
|
|
(5,304,862 |
) |
|
|
(5,609,463 |
) |
|
|
(11,580,037 |
) |
|
|
(113,831,045 |
) |
|
|
|
|
|
|
|
|
|
|
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|
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|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSE): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
3,441 |
|
|
|
100,992 |
|
|
|
35,193 |
|
|
|
380,997 |
|
|
|
1,948,769 |
|
Interest expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,129,502 |
) |
Loss on sales of investment securities net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,942 |
) |
Cancelled offering costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(584,707 |
) |
Gain on extinguishment of debt |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,427,765 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-3-
|
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|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
October 15, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1984 |
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
(Inception) to |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
|
Other income |
|
|
3,441 |
|
|
|
100,992 |
|
|
|
35,193 |
|
|
|
380,997 |
|
|
|
1,659,383 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS |
|
|
(1,882,583 |
) |
|
|
(5,203,870 |
) |
|
|
(5,574,270 |
) |
|
|
(11,199,040 |
) |
|
|
(112,171,662 |
) |
|
|
|
|
|
|
|
|
|
|
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|
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|
|
|
|
|
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|
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CONVERTIBLE PREFERRED STOCK DIVIDENDS AND CONVERTIBLE
PREFERRED STOCK PREMIUM DEEMED DIVIDENDS |
|
|
(112,746 |
) |
|
|
(132,629 |
) |
|
|
(360,826 |
) |
|
|
(402,608 |
) |
|
|
(7,700,159 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
REDEEMABLE PREFERRED STOCK CONVERSION, PREMIUM
AMORTIZATION AND DIVIDENDS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,369,899 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS |
|
$ |
(1,995,329 |
) |
|
$ |
(5,336,499 |
) |
|
$ |
(5,935,096 |
) |
|
$ |
(11,601,648 |
) |
|
$ |
(117,501,922 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED NET LOSS PER SHARE ATTRIBUTABLE
TO COMMON STOCKHOLDERS: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(0.11 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.73 |
) |
|
|
|
|
Convertible preferred stock dividends and convertible
preferred stock premium deemed dividends |
|
|
(0.01 |
) |
|
|
(0.01 |
) |
|
|
(0.02 |
) |
|
|
(0.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED LOSS PER SHARE ATTRIBUTABLE
TO COMMON STOCKHOLDERS |
|
$ |
(0.12 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.37 |
) |
|
$ |
(0.75 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE SHARES USED IN COMPUTING
BASIC AND DILUTED NET LOSS PER SHARE |
|
|
16,514,627 |
|
|
|
15,534,138 |
|
|
|
16,115,052 |
|
|
|
15,438,240 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See notes to consolidated financial statements (unaudited).
-4-
IMMTECH PHARMACEUTICALS, INC. AND SUBSIDIARIES
(A Development Stage Enterprise)
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
October 15, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1984 |
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
(Inception) to |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(1,882,583 |
) |
|
$ |
(5,203,870 |
) |
|
$ |
(5,574,270 |
) |
|
$ |
(11,199,040 |
) |
|
$ |
(112,171,662 |
) |
Adjustments to reconcile net loss to net cash used in
operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation recorded related to issuance of common stock,
common stock options and warrants |
|
|
199,285 |
|
|
|
724,611 |
|
|
|
194,376 |
|
|
|
2,118,562 |
|
|
|
34,059,163 |
|
Depreciation and amortization of property and equipment |
|
|
11,193 |
|
|
|
35,571 |
|
|
|
74,492 |
|
|
|
109,071 |
|
|
|
1,407,729 |
|
(Gain)/Loss on disposal of fixed assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,982 |
|
Equity in loss of joint venture |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
135,002 |
|
Asset impairment charge |
|
|
503,778 |
|
|
|
|
|
|
|
1,196,851 |
|
|
|
|
|
|
|
1,196,851 |
|
Loss on sales of investment securities net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,942 |
|
Amortization of debt discounts and issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
134,503 |
|
Gain on extinguishment of debt |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,427,765 |
) |
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other receivables |
|
|
|
|
|
|
|
|
|
|
54,205 |
|
|
|
|
|
|
|
|
|
Other current assets |
|
|
73,866 |
|
|
|
(88,788 |
) |
|
|
90,134 |
|
|
|
(389,233 |
) |
|
|
(162,880 |
) |
Other assets |
|
|
(4,886 |
) |
|
|
(165,750 |
) |
|
|
(13,589 |
) |
|
|
(461,802 |
) |
|
|
(47,731 |
) |
Accounts payable |
|
|
159,803 |
|
|
|
1,415,919 |
|
|
|
(1,960,634 |
) |
|
|
257,262 |
|
|
|
1,305,412 |
|
Accrued expenses |
|
|
(106,567 |
) |
|
|
753,378 |
|
|
|
(182,251 |
) |
|
|
629,531 |
|
|
|
980,532 |
|
Deferred revenue |
|
|
(562,631 |
) |
|
|
6,217,499 |
|
|
|
(2,226,643 |
) |
|
|
7,281,869 |
|
|
|
173,033 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities |
|
|
(1,608,742 |
) |
|
|
3,688,570 |
|
|
|
(8,347,329 |
) |
|
|
(1,653,780 |
) |
|
|
(74,408,889 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-5-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
October 15, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1984 |
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
(Inception) to |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
|
INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
|
(3,013 |
) |
|
|
(4,854 |
) |
|
|
(7,077 |
) |
|
|
(4,854 |
) |
|
|
(1,643,199 |
) |
Restricted funds on deposit |
|
|
448,356 |
|
|
|
(4,268,611 |
) |
|
|
3,272,108 |
|
|
|
(1,843,576 |
) |
|
|
(504,145 |
) |
Advances to joint venture |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(135,002 |
) |
Proceeds from maturities of investment securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,800,527 |
|
Purchases of investment securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,803,469 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
445,343 |
|
|
|
(4,273,465 |
) |
|
|
3,265,031 |
|
|
|
(1,848,430 |
) |
|
|
(2,285,288 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Advances from stockholders and affiliates |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
985,172 |
|
Proceeds from issuance of notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,645,194 |
|
Principal payments on notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(218,119 |
) |
Payments for debt issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(53,669 |
) |
Payments for extinguishment of debt |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(203,450 |
) |
Net proceeds from issuance of redeemable preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,330,000 |
|
Net proceeds from issuance of convertible preferred stock and warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,085,434 |
|
Payments of convertible preferred stock dividends and for fractional shares of
common stock resulting from the conversions of convertible preferred stock |
|
|
(26 |
) |
|
|
(513 |
) |
|
|
(89 |
) |
|
|
(979 |
) |
|
|
(6,664 |
) |
Net proceeds from issuance of common stock |
|
|
|
|
|
|
189,679 |
|
|
|
|
|
|
|
485,590 |
|
|
|
53,798,490 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional capital contributed by stockholders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
245,559 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities |
|
|
(26 |
) |
|
|
189,166 |
|
|
|
(89 |
) |
|
|
484,611 |
|
|
|
77,607,947 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
|
|
(1,163,425 |
) |
|
|
(395,729 |
) |
|
|
(5,082,387 |
) |
|
|
(3,017,599 |
) |
|
|
913,770 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD |
|
|
2,077,195 |
|
|
|
9,839,925 |
|
|
|
5,996,157 |
|
|
|
12,461,795 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS, END OF PERIOD |
|
$ |
913,770 |
|
|
$ |
9,444,196 |
|
|
$ |
913,770 |
|
|
$ |
9,444,196 |
|
|
$ |
913,770 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See notes to consolidated financial statements (unaudited).
-6-
IMMTECH PHARMACEUTICALS, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
The accompanying consolidated financial statements have been prepared by Immtech
Pharmaceuticals, Inc. and its subsidiaries (the Company or Immtech) pursuant to the
rules and regulations of the Securities and Exchange Commission (SEC) and, in the opinion
of management, include all adjustments necessary for a fair statement of results for each
period shown (unless otherwise noted herein, all adjustments are of a normal recurring
nature). Certain information and footnote disclosures normally included in financial
statements prepared in accordance with accounting principles generally accepted in the
United States of America have been condensed or omitted pursuant to such SEC rules and
regulations. The Company, with a fiscal year ending March 31, believes that the disclosures
made are adequate to prevent the financial information given from being misleading. It is
suggested that these financial statements be read in conjunction with the financial
statements and notes thereto included in the Companys latest Annual Report on Form 10-K.
2. |
|
COMPANY BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
Description of Business Immtech Pharmaceuticals, Inc. and subsidiaries (a development
stage enterprise) is focused on global opportunities in the healthcare sector and
opportunities in China. Immtech aims to apply its established expertise and other assets in
both new drug sales and enhanced healthcare-related services, including research and
information-providing services, for developed and developing countries. We plan to further
our focus on the discovery and development of drugs to treat infectious diseases.
During the year ended March 31, 2008, the Companys drug development program for
pafuramidine was discontinued due to findings of renal and liver adverse events among
participants in the study of healthy volunteers conducted in South Africa. It was halted in
December 2007 after several subjects developed abnormal liver function. The program was
formally discontinued in February 2008 when five subjects in the same study developed renal
abnormalities that required medical intervention and hospitalization.
The Company holds worldwide patents and patent applications, and licenses and rights to
license technology, primarily from a scientific consortium that has granted to the Company
exclusive rights to commercialize products from, and license rights to the technology. The
scientific consortium includes scientists from The University of North Carolina at Chapel
Hill (UNC-CH), Georgia State University (Georgia State), Duke University and Auburn
University (collectively, the Scientific Consortium). The Company is a development stage
enterprise and, since its inception on October 15, 1984,
has engaged in research and development programs, expanded its network of scientists and
scientific advisors and licensing technology agreements, and worked to commercialize the
aromatic cation pharmaceutical technology platform. (The Company acquired its rights to the
aromatic cation technology platform in 1997 and promptly thereafter commenced development of
its current programs.) The Company uses the expertise and resources of strategic partners
and third parties in a number of areas, including: (i) laboratory research, (ii) animal and
human trials and (iii) the manufacture of pharmaceutical drugs.
-7-
The Company does not have any products currently available for sale, and no products are
expected to be commercially available for sale until after March 31, 2009, if at all.
Going Concern Presentation and Related Risks and Uncertainties The accompanying financial
statements have been prepared on a going concern basis, which contemplates the realization
of assets and the satisfaction of liabilities in the normal course of business.
Since inception, the Company has incurred accumulated net losses of approximately
$112,172,000. Management expects the Company will continue to incur significant losses
during the next several years as the Company continues development activities, clinical
trials and commercialization efforts. In addition, the Company has various research and
development agreements with third parties and is dependent upon such parties abilities to
perform under these agreements. There can be no assurance that the Companys activities
will lead to the development of commercially viable products. The Companys operations to
date have consumed substantial amounts of cash. The negative cash flow from operations is
expected to continue in the foreseeable future. The Company believes it will require
substantial additional funds to commercialize its drug candidates. The Companys cash
requirements may vary materially from those now planned when and if the following become
known: formation and development of relationships with strategic partners, changes in the
focus and direction of development programs, results of research and development efforts,
results of clinical testing, responses to grant requests, competitive and technological
advances, requirements in the regulatory process and other factors. Changes in
circumstances in any of our global business initiatives may require the Company to allocate
substantially more funds than are currently available or than management intends to raise.
The Company believes its existing unrestricted cash and cash equivalents, and the grants the
Company has received or has been awarded, and proceeds from the January 12, 2009 sale of
land use rights in Shenzhen, China (see Note 6) will be sufficient to meet the Companys
planned expenditures through at least June 30, 2009, although there can be no assurance the
Company will not require additional funds. The decision to terminate the pafuramidine
development program has significantly depressed the Companys stock price and impaired its
ability to raise additional funds. The Company is evaluating its strategic alternatives
with respect to all aspects of the business. These factors, among others, indicate that the
Company may be unable to continue as a going concern. The accompanying financial statements
do not include any adjustments that might result from the outcome of these uncertainties.
-8-
The Companys cash resources have been used to finance, develop and begin commercialization
of drug product candidates, including sponsored research, conducting human clinical trials,
capital expenditures, expenses associated with the development of product candidates
pursuant to the Consortium Agreement, and, as contemplated by the Consortium Agreement,
under the License Agreement with the Scientific Consortium, and general and administrative
expenses. Over the next several years the Company expects to incur substantial additional
research and development costs, including costs related to research in preclinical
(laboratory) and human clinical trials, administrative expenses to support our research and
development operations and marketing expenses to launch the sale of any commercialized
product that may be developed.
The Companys future working capital requirements will depend upon numerous factors,
including the progress of research, development and commercialization programs (which may
vary as product candidates are added or abandoned), results of preclinical testing and human
clinical trials, achievement of regulatory milestones, the level of resources that the
Company devotes to the engagement or development of manufacturing capabilities, the
Companys ability to maintain existing and to establish new collaborative arrangements with
others to provide funding to support these activities, and other factors. In any event, the
Company will require substantial funds in addition to its existing resources to develop
product candidates and to otherwise meet its business objectives.
Principles of Consolidation The consolidated financial statements include the accounts of
Immtech Pharmaceuticals, Inc. and its wholly owned subsidiaries. All intercompany balances
and transactions have been eliminated.
Cash and Cash Equivalents The Company considers all highly liquid investments with a
maturity of three months or less when purchased to be cash equivalents. Cash and cash
equivalents consist of an amount on deposit at a bank and an investment in a money market
mutual fund, stated at cost, which approximates fair value.
Restricted Funds on Deposit Restricted funds on deposit consist of cash on deposit at a
bank which are restricted, for use in accordance with a clinical research subcontract
agreement with UNC-CH.
Concentration of Credit Risk The Company maintains its cash in commercial banks.
Balances on deposit are insured by the Federal Deposit Insurance Corporation (FDIC) up to
specified limits.
Investment The Company accounts for its investment in NextEra Therapeutics, Inc.
(NextEra) on the equity method. As of December 31, 2008 and March 31, 2008, the Company
owned approximately 28% of the issued and outstanding shares of NextEra common stock. The
Company has recognized an equity loss in NextEra to the extent of the basis of its
investment, and the investment balance is zero as of December 31, 2008 and March 31, 2008.
Recognition of any investment income on the equity method by the Company for its investment
in NextEra will occur only after NextEra has earnings in excess of previously unrecognized
equity losses. The Company does not provide, and has not provided, any financial guarantees
to NextEra.
-9-
Property and Equipment Property and equipment are recorded at cost and depreciated and
amortized using the straight-line method over the estimated useful lives of the respective
assets, ranging from three to five years. Leasehold improvements are amortized over the
lesser of the life of the related lease or their useful lives.
Prepaid Rent Prepaid rent relates to land use rights that the Company has recorded at
cost (adjusted for impairment charges of $1,196,851) and amortized using the straight-line
method over the estimated useful life of fifty years. The land use rights were sold
subsequent to December 31, 2008 for $2,000,000 (see Note 6).
During the second quarter of fiscal year 2009, the Company recorded a non-cash asset
impairment charge related to the land use rights in Shenzhen, China in the amount of
$693,073. In the third quarter of fiscal year 2009, an additional non-cash asset impairment
charge of $503,778 was recorded. The changes result from the volatility and disruption of
the capital and credit markets, adverse changes in the global economy, and subsequent sale
of the land use rights.
Long-Lived Assets The Company periodically evaluates the carrying value of its property
and equipment. Long-lived assets are reviewed for impairment whenever events or changes in
circumstances indicate that the carrying amount may not be recoverable. If the sum of the
expected future undiscounted cash flows is less than the carrying amount of an asset, a loss
is recognized for the asset which is measured by the difference between the fair value and
the carrying value of the asset.
Revenue Recognition Grants to perform research have been the Companys primary source of
revenue and are generally granted to support research and development activities for
specific projects or drug candidates. Revenue related to grants to perform research and
development is recognized as earned based on the performance requirements of the specific
grant. Upfront cash payments from research and development grants are reported as deferred
revenue until such time as the research and development activities covered by the grant are
performed.
Revenue from licensing arrangements is recorded when earned based on the performance
requirements of the contract. Nonrefundable upfront license fees, for product candidates
where the Company is providing continuing services related to product development, are
deferred and recognized as revenue over the development period or as the Company provides
services required under the agreement. The timing and amount of revenue the Company
recognizes from licenses, either from upfront fees or milestones where the Company is
providing continuing services related to product development, is dependent upon the
Companys estimates of filing dates. As product candidates move through the development
process, it is necessary to revise these estimates to consider changes to the product
development cycle, such as changes in the clinical development plan, regulatory
requirements, or various other factors, many of which may be outside of the Companys
control. The impact on revenue changes in the Companys estimates and the timing thereof, is
recognized prospectively over the remaining estimated product development period.
-10-
Research and Development Costs Research and development costs are expensed as incurred
and include costs associated with research performed pursuant to collaborative agreements.
Research and development costs consist of direct and indirect internal costs related to
specific projects as well as fees paid to other entities that conduct certain research
activities on the Companys behalf.
Income Taxes The Company accounts for income taxes using an asset and liability approach.
Deferred income tax assets and liabilities are computed annually for differences between the
financial statement and tax bases of assets and liabilities that will result in taxable or
deductible amounts in the future based on enacted tax laws and rates applicable to the
periods in which the differences are expected to affect taxable income. In addition, a
valuation allowance is recognized if it is more likely than not that some or all of the
deferred income tax assets will not be realized. A valuation allowance is used to offset the
related net deferred income tax assets due to uncertainties of realizing the benefits of
certain net operating loss and tax credit carry-forwards and other deferred income tax
assets.
Net Income (Loss) Per Share Net income (loss) per share is calculated in accordance with
Statement of Financial Accounting Standard (SFAS) No. 128, Earnings Per Share. Basic net
income (loss) and diluted net income (loss) per share are computed by dividing net income
(loss) attributable to common stockholders by the weighted average number of common shares
outstanding. Diluted net income per share, when applicable, is computed by dividing net
income attributable to common stockholders by the weighted average number of common shares
outstanding increased by the number of potential dilutive common shares based on the
treasury stock method. Diluted net loss per share was the same as the basic net loss per
share for the three and nine month periods ended December 31, 2008 and 2007, as none of the
Companys outstanding common stock options, warrants and the conversion features of Series
A, B, C, and D Convertible Preferred Stock (as described below) were dilutive.
Stock-Based Compensation Effective April 1, 2006, the Company adopted SFAS No. 123(R),
Share-Based Payment, using the modified prospective method. SFAS No. 123(R) requires
entities to recognize the cost of employee services in exchange for awards of equity
instruments based on the grant-date fair value of those awards (with limited exceptions).
The cost, based on the estimated number of awards that are expected to vest, will be
recognized over the period during which the employee is required to provide the services in
exchange for the award. No compensation cost is recognized for awards for which employees
do not render the requisite service. Upon adoption, the grant-date fair value of employee
share options and similar instruments was estimated using the Black-Scholes valuation model.
The Black-Scholes valuation requires the input of highly subjective assumptions, including
the expected life of the stock-based award and stock price volatility. The assumptions used
are managements best estimates, but the estimates involve inherent uncertainties and the
application of managements judgment. As a result, if other assumptions had been used, the
recorded and pro forma stock-based compensation expense could have been materially different
from that depicted in the financial statements.
-11-
Fair Value of Financial Instruments The Company believes that the carrying amount of its
financial instruments (cash and cash equivalents, restricted funds on deposit, accounts
payable and accrued expenses) approximates the fair value of such instruments as of December
31, 2008 and March 31, 2008 based on the short-term nature of the instruments.
Segment Reporting The Company is a development stage pharmaceutical company that operates
as one segment.
Comprehensive Loss There were no differences between comprehensive loss and net loss for
the three and nine month periods ended December 31, 2008 and 2007, respectively.
Use of Estimates The preparation of financial statements in conformity with accounting
principles generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial statements and
the reported amounts of revenues and expenses during the reporting period. Actual results
could differ materially from these estimates.
New Accounting Standard The Company adopted Financial Accounting Standards Board
(FASB), Interpretation No. 48, Accounting for Uncertainty in Income Taxes, (FIN 48) on
April 1, 2007. The adoption of FIN 48 did not have an impact. At the adoption date and as
of December 31, 2008, the Company does not have a liability for uncertain tax benefits. The
Company does not presently expect any reasonably possible material change to the estimated
amount of liability associated with its uncertain tax positions during the next twelve
months. Additionally, there were no interest or penalties related to income taxes that have
been accrued or recognized for open tax years.
The Company files income tax returns in the U.S. federal jurisdiction, and various state
jurisdictions. Periods subject to examination for the Companys federal tax return are the
1991 through 2007 tax years. In addition, open tax years related to state jurisdictions
remain subject to examination but are not considered material.
New Accounting Standard In December 2007, the FASB issued Statement No. 141 (revised
2007), Business Combinations (SFAS 141(R)). SFAS 141(R) changes the requirements for an
acquirers recognition and measurement of the assets acquired and the liabilities assumed in
a business combination. SFAS 141(R) is effective for the Company in fiscal year 2010. The
impact of SFAS 141(R) will depend on future acquisitions.
New Accounting Standard In September 2006, the FASB issued Statement No. 157 (SFAS
157), Fair Value Measurements. SFAS 157 defines fair value, establishes a framework for
measuring fair value in accordance with generally accepted accounting principles, and
expands disclosures about fair value measurements. Subsequently in February 2008, the FASB
issued FASB Staff Position 157-1, Application of FASB Statement No. 157 to FASB Statement
No. 13 and Other Accounting Pronouncements That Address Fair Value Measurements for Purposes
of Lease Classification or
Measurement under Statement 13 (FSP 157-1) and FASB Staff Position 157-2, Partial
Deferral of the Effective Date of Statement 157 (FSP 157-2). FSP 157-1 removed leasing
transactions accounted for under Statement No. 13 and related guidance from the scope of
SFAS 157. FSP 157-2 deferred the effective date of SFAS 157 for all nonfinancial assets and
nonfinancial liabilities to fiscal years beginning after November 15, 2008. SFAS 157 has
been effective for us in fiscal year 2009. The impact of adoption has not been material.
-12-
New Accounting Standard In February 2007, the FASB issued Statement No. 159 (SFAS 159),
Fair Value Option for Financial Assets and Financial Liabilities. SFAS 159 establishes the
irrevocable option to elect to carry certain financial assets and liabilities at fair value,
with changes in fair value recorded in earnings. SFAS 159 has been effective for the Company
in fiscal year 2009. The Company has assessed the standard and did not elect the fair value
option.
New Accounting Standard In December 2007, the FASB issued Statement No. 160,
Non-controlling Interests in Consolidated Financial Statements, an amendment of ARB No. 51
(SFAS 160). SFAS 160 requires that (a) non-controlling (minority) interests be reported as
a component of shareholders equity, (b) net income attributable to the parent and to the
non-controlling interest be separately identified in the consolidated statement of
operations, (c) changes in a parents ownership interest while the parent retains its
controlling interest be accounted for as equity transactions, (d) any retained
non-controlling equity investment upon the deconsolidation of a subsidiary be initially
measured at fair value, and (e) sufficient disclosures are provided that clearly identify
and distinguish between the interests of the parent and the interests of the non-controlling
owners. SFAS 160 is effective for the Company in fiscal year 2010 and should be applied
prospectively. However, the presentation and disclosure requirements of the statement shall
be applied retrospectively for all periods presented. The Company does not expect the impact
of adoption to be material.
New Accounting Standard In May 2008, the FASB issued Statement No. 162, The Hierarchy of
Generally Accepted Accounting Principles (SFAS 162). This statement identifies the
sources of accounting principles and the framework for selecting the principles that are
presented in conformity with generally accepted accounting principles in the United States
of America. This statement became effective during November 2008. The adoption of SFAS 162
had no impact on the Companys consolidated financial statements.
On January 7, 2004, the stockholders of the Company approved an increase in the number of
authorized common stock from 30 million to 100 million shares. On June 14, 2004, the Company
filed with the Secretary of State of the State of Delaware an Amended and Restated
Certificate of Incorporation implementing, among other things, the approved authorized 70
million share common stock increase from 30 million to 100 million shares of common stock.
-13-
Series A Convertible Preferred Stock On February 14, 2002, the Company filed a Certificate
of Designation with the Secretary of State of the State of Delaware designating 320,000
shares of the Companys 5,000,000 authorized shares of preferred stock as Series A
Convertible Preferred Stock, $0.01 par value, with a stated value of $25.00 per share.
Dividends accrue at a rate of 6.0% per annum on the $25.00 stated value per share and are
payable semi-annually on April 15 and October 15 of each year while the shares are
outstanding. The Company has the option to pay the dividend either in cash or in equivalent
shares of common stock, as defined. Included in the carrying value of the Series A
Convertible Preferred Stock in the accompanying condensed consolidated balance sheets are
$9,883 and $34,331 of accrued preferred stock dividends at December 31, 2008 and March 31,
2008, respectively. Each share of Series A Convertible Preferred Stock may be converted by
the holder at any time into shares of our common stock at a conversion rate determined by
dividing the $25.00 stated value, plus any accrued and unpaid dividends (the Liquidation
Price A), by a $4.42 conversion price (the Conversion Price A), subject to certain
adjustments, as defined in the Series A Certificate of Designation. On October 17, 2007, the
Company issued 5,106 shares of common stock and paid $108 in lieu of fractional common
shares as dividends on the preferred shares. On October 15, 2008, the Company issued 48,777
shares of common stock and paid $5 in lieu fractional common shares as dividends on the
preferred shares. On April 15, 2007, the Company issued 6,308 shares of common stock and
paid $87 in lieu of fractional common shares as dividends on the preferred shares. On April
15, 2008, the Company issued 40,686 shares of common stock and paid $15 in lieu of
fractional common shares as dividends on the preferred shares. During the three month
periods ended December 31, 2007 and 2008, there were no conversions of Series A Convertible
Preferred Stock. During the nine month periods ended December 31, 2007 and 2008, certain
preferred stockholders converted 1,000 and 18,000 shares of Series A Convertible Preferred
Stock, including accrued dividends, for 5,701 and 108,153 shares of common stock,
respectively.
The Company may at any time require that any or all outstanding shares of Series A
Convertible Preferred Stock be converted into shares of the Companys common stock, provided
that the shares of common stock into which the Series A Convertible Preferred Stock are
convertible are registered pursuant to an effective registration statement, as defined. The
number of shares of common stock to be received by the holders of the Series A Convertible
Preferred Stock upon a mandatory conversion by the Company is determined by (i) dividing the
Liquidation Price by the Conversion Price A, provided that the closing bid price for the
Companys common stock exceeds $9.00 for 20 consecutive trading days within 180 days prior
to notice of conversion, as defined, or (ii) if the requirements of (i) are not met, the
number of shares of common stock is determined by dividing 110% of the Liquidation Price A
by the Conversion Price A. The Conversion Price A is subject to certain adjustments, as
defined in the Series A Certificate of Designation.
-14-
The Company may at any time, upon 30 days notice, redeem any or all outstanding shares of
the Series A Convertible Preferred Stock by payment of the Liquidation Price A to the holder
of such shares, provided that the holder does not convert the Series A Convertible Preferred
Stock into shares of common stock during the 30 day period. The
Series A Convertible Preferred Stock has a preference in liquidation equal to $25.00 per
share, plus any accrued and unpaid dividends, over the common stock and is pari passu with
all other outstanding series of preferred stock. Each issued and outstanding share of Series
A Convertible Preferred Stock shall be entitled to 5.6561 votes (subject to adjustment) with
respect to any and all matters presented to the Companys stockholders for their action or
consideration. Except as provided by law or by the provisions establishing any other series
of preferred stock, holders of Series A Convertible Preferred Stock and holders of any other
outstanding preferred stock shall vote together with the holders of common stock as a single
class.
Series B Convertible Preferred Stock On September 25, 2002, the Company filed a
Certificate of Designation with the Secretary of State of the State of Delaware designating
240,000 shares of the Companys 5,000,000 authorized shares of preferred stock as Series B
Convertible Preferred Stock, $0.01 par value, with a stated value of $25.00 per share.
Dividends accrue at a rate of 8.0% per annum on the $25.00 stated value per share and are
payable semi-annually on April 15 and October 15 of each year while the shares are
outstanding. The Company has the option to pay the dividend either in cash or in equivalent
shares of common stock, as defined. Included in the carrying value of the Series B
Convertible Preferred Stock in the accompanying condensed consolidated balance sheets are
$3,518 and $10,180 of accrued preferred stock dividends as of December 31, 2008 and March
31, 2008, respectively. Each share of Series B Convertible Preferred Stock may be converted
by the holder at any time into shares of common stock at a conversion rate determined by
dividing the $25.00 stated value, plus any accrued and unpaid dividends (the Liquidation
Price B), by a $4.00 conversion price (the Conversion Price B), subject to certain
adjustments, as defined in the Series B Certificate of Designation. On October 17, 2007, the
Company issued 1,682 shares of common stock and paid $35 in lieu of fractional common shares
as dividends on the preferred shares. On October 15, 2008, the Company issued 18,938 shares
of common stock and paid $2 in lieu of fractional common shares as dividends on the
preferred shares. On April 15, 2007, the Company issued 2,040 shares of common stock and
paid $30 in lieu of fractional common shares as dividends on the preferred shares. On April
15, 2008, the Company issued 12,316 shares of common stock and paid $3 in lieu of fractional
common shares as dividends on the preferred shares. During the three month and nine month
periods ended December 31, 2007, a preferred shareholder converted 2,000 shares of Series B
Convertible Preferred Stock, including accrued dividends, for 12,574 shares of common stock.
During the three month period ended December 31, 2008, there were no conversions. During the
nine month period ended December 31, 2008, a preferred shareholder converted 2,000 shares of
Series B Convertible Preferred Stock, including accrued dividends, for 13,129 shares of
common stock.
The Company may at any time require that any or all outstanding shares of Series B
Convertible Preferred Stock be converted into shares of the Companys common stock, provided
that the shares of common stock into which the Series B Convertible Preferred Stock are
convertible are registered pursuant to an effective registration statement, as defined. The
number of shares of common stock to be received by the holders of the Series B Convertible
Preferred Stock upon a mandatory conversion by the Company is determined by (i) dividing the
Liquidation Price B by the Conversion Price B, provided
that the closing bid price for the Companys common stock exceeds $9.00 for 20 consecutive
trading days within 180 days prior to notice of conversion, as defined, or (ii) if the
requirements of (i) are not met, the number of shares of common stock is determined by
dividing 110% of the Liquidation Price B by the Conversion Price B. The Conversion Price B
is subject to certain adjustments, as defined in the Series B Certificate of Designation.
-15-
The Company may at any time, upon 30 days notice, redeem any or all outstanding shares of
the Series B Convertible Preferred Stock by payment of the Liquidation Price B to the holder
of such shares, provided that the holder does not convert the Series B Convertible Preferred
Stock into shares of common stock during the 30 day period. The Series B Convertible
Preferred Stock has a preference in liquidation equal to $25.00 per share, plus any accrued
and unpaid dividends over the common stock and is pari passu with all other outstanding
series of preferred stock. Each issued and outstanding share of Series B Convertible
Preferred Stock shall be entitled to 6.25 votes (subject to adjustment) with respect to any
and all matters presented to the Companys stockholders for their action or consideration.
Except as provided by law or by the provisions establishing any other series of preferred
stock, Series B Convertible Preferred stockholders and holders of any other outstanding
preferred stock shall vote together with the holders of common stock as a single class.
Series C Convertible Preferred Stock On June 6, 2003, the Company filed a Certificate of
Designation with the Secretary of State of the State of Delaware designating 160,000 shares
of the Companys 5,000,000 authorized shares of preferred stock as Series C Convertible
Preferred Stock, $0.01 par value, with a stated value of $25.00 per share. Dividends accrue
at a rate of 8.0% per annum on the $25.00 stated value per share and are payable
semi-annually on April 15 and October 15 of each year while the shares are outstanding. The
Company has the option to pay the dividend either in cash or in equivalent shares of common
stock, as defined. Included in the carrying value of the Series C Convertible Preferred
Stock in the accompanying condensed consolidated balance sheets are $19,489 and $41,945 of
accrued preferred stock dividends as of December 31, 2008 and March 31, 2008, respectively.
Each share of Series C Convertible Preferred Stock may be converted by the holder at any
time into shares of common stock at a conversion rate determined by dividing the $25.00
stated value, plus any accrued and unpaid dividends (the Liquidation Price C), by a $4.42
conversion price (the Conversion Price C), subject to certain adjustments, as defined in
the Series C Certificate of Designation. On October 17, 2007, the Company issued 5,694
shares of common stock and paid $75 in lieu of fractional common shares as dividends on the
preferred shares. On October 15, 2008, the Company issued 91,126 shares of common stock and
paid $7 in lieu of fractional common shares as dividends on the preferred shares. On April
15, 2007, the Company issued 6,900 shares of common stock and paid $99 in lieu of fractional
common shares as dividends on the preferred shares. On April 15, 2008, the Company issued
48,919 shares of common stock and paid $14 in lieu of fractional common shares as dividends
on the preferred shares. During the three and nine month periods ended December 31, 2007
and 2008, there were no conversions.
-16-
The Company may at any time require that any or all outstanding shares of Series C
Convertible Preferred Stock be converted into shares of the Companys common stock, provided
that the shares of common stock into which the Series C Convertible Preferred Stock are
convertible are registered pursuant to an effective registration statement, as defined. The
number of shares of common stock to be received by the holders of the Series C Convertible
Preferred Stock upon a mandatory conversion by the Company is determined by (i) dividing the
Liquidation Price C by the Conversion Price C provided that the closing bid price for the
Companys common stock exceeds $9.00 for 20 consecutive trading days within 180 days prior
to notice of conversion, as defined, or (ii) if the requirements of (i) are not met, the
number of shares of common stock is determined by dividing 110% of the Liquidation Price C
by the Conversion Price C. The Conversion Price C is subject to certain adjustments, as
defined in the Series C Certificate of Designation.
The Company may at any time, upon 30 days notice, redeem any or all outstanding shares of
the Series C Convertible Preferred Stock by payment of the Liquidation Price C to the holder
of such shares, provided that the holder does not convert the Series C Convertible Preferred
Stock into shares of common stock during the 30 day period. The Series C Convertible
Preferred Stock has a preference in liquidation equal to $25.00 per share, plus any accrued
and unpaid dividends, over the common stock and is pari passu with all other outstanding
series of preferred stock. Each issued and outstanding share of Series C Convertible
Preferred Stock shall be entitled to 5.6561 votes (subject to adjustment) with respect to
any and all matters presented to the Companys stockholders for their action or
consideration. Except as provided by law or by the provisions establishing any other series
of preferred stock, Series C Convertible Preferred stockholders and holders of any other
outstanding preferred stock shall vote together with the holders of common stock as a single
class.
Series D Convertible Preferred Stock On January 15, 2004, the Company filed a Certificate
of Designation with the Secretary of State of the State of Delaware designating 200,000
shares of the Companys 5,000,000 authorized shares of preferred stock as Series D
Convertible Preferred Stock, $0.01 par value, with a stated value of $25.00 per share.
Dividends accrue at a rate of 6.0% per annum on the $25.00 stated value per share and are
payable semi-annually on April 15 and October 15 of each year while the shares are
outstanding. The Company has the option to pay the dividend either in cash or in equivalent
shares of common stock, as defined. Included in the carrying value of the Series D
Convertible Preferred Stock in the accompanying condensed consolidated balance sheets are
$36,925 and $79,533 of accrued preferred stock dividends as of December 31, 2008 and March
31, 2008, respectively. Each share of Series D Convertible Preferred Stock may be converted
by the holder at any time into shares of common stock at a conversion rate determined by
dividing the $25.00 stated value, plus any accrued and unpaid dividends (the Liquidation
Price D), by a $9.00 conversion price (the Conversion Price D), subject to certain
adjustments, as defined in the Series D Certificate of Designation. On October 17, 2007, the
Company issued 10,804 shares of common stock and paid $140 in lieu of fractional common
shares as dividends on the preferred share. On October 15, 2008, the Company issued 172,912
shares of common stock and paid $8 in lieu of
-17-
fractional common shares as dividends on
the preferred shares. On April 15, 2007, the Company issued 13,334 shares of common stock
and paid $95 in lieu of fractional common shares as dividends on the preferred shares. On
April 15, 2008, the Company issued 92,831 shares of common stock and paid $16 in lieu of
fractional common shares as dividends on the preferred shares. During the three month
period ended December 31, 2007, there were no conversions. During the nine month period
ended December 31, 2007, certain preferred stockholders converted 2,000 shares of Series D
Convertible Preferred Stock, including accrued dividends, for 5,653 shares of common stock,
respectively. During the three and nine month periods ended December 31, 2008, there were no
conversions.
The Company may at any time, require that any or all outstanding shares of Series D
Convertible Preferred Stock be converted into shares of our common stock, provided that the
shares of common stock into which the Series D Convertible Preferred Stock are convertible
are registered pursuant to an effective registration statement, as defined. The number of
shares of common stock to be received by the holders of the Series D Convertible Preferred
Stock upon a mandatory conversion by the Company is determined by (i) dividing the
Liquidation Price D by the Conversion Price D provided that the closing bid price for the
Companys common stock exceeds $18.00 for 20 consecutive trading days within 180 days prior
to notice of conversion, as defined, or (ii) if the requirements of (i) are not met, the
number of shares of common stock is determined by dividing 110% of the Liquidation Price D
by the Conversion Price D. The Conversion Price D is subject to certain adjustments, as
defined in the Certificate of Designation.
The Series D Convertible Preferred Stock has a preference in liquidation equal to $25.00 per
share, plus any accrued and unpaid dividends, over the common stock and is pari passu with
all other series of preferred stock. Each issued and outstanding share of Series D
Convertible Preferred Stock shall be entitled to 2.7778 votes (subject to adjustment) with
respect to any and all matters presented to the Companys stockholders for their action or
consideration. Except as provided by law or by the provisions establishing any other series
of preferred stock, Series D Convertible Preferred stockholders and holders of any other
outstanding preferred stock shall vote together with the holders of common stock as a single
class.
Series E
Convertible Preferred Stock On December 13, 2005, the Company filed a Certificate
of Designation with the Secretary of State of the State of Delaware designating 167,000
shares of the Companys 5,000,000 authorized shares of preferred stock as Series E
Convertible Preferred Stock, $0.01 par value, with a stated value of $25.00 per share.
Dividends accrued at a rate of 6.0% per annum on the $25.00 stated value per share and were
payable semi-annually on April 15 and October 15 of each year while the shares were
outstanding. The Company had the option to pay the dividend either in cash or in equivalent
shares of common stock, as defined. Included in the carrying value of the Series E
Convertible Preferred Stock in the accompanying condensed consolidated balance sheets is
$68,107 of accrued preferred stock dividends as of March 31, 2008. Each share of Series E
Convertible Preferred Stock could have been converted by the holder, at any time prior to
December 13, 2008, into shares of common stock at a conversion rate determined by dividing
the $25.00 stated value, plus any accrued and unpaid dividends (the Liquidation Price E),
by a $7.04 conversion price (the Conversion
-18-
Price E), subject to certain adjustments, as defined in the Series E
Certificate of Designation. On October 17, 2007, the Company issued 9,995 shares of common
stock and paid $149 in lieu of fractional common shares as dividends on the preferred
shares. On October 15, 2008, the Company issued 146,798 shares of common stock and paid $5
in lieu of fractional common shares as dividends on the preferred shares. On April 15, 2007,
the Company issued 12,531 shares of common stock and paid $132 in lieu of fractional common
shares as dividends on the preferred shares. On April 15, 2008, the Company issued 79,532
shares of common stock and paid $13 in lieu of fractional common shares as dividends on the
preferred shares. During the three and nine month periods ended December 31, 2007, certain
preferred stockholders converted 8,000 and 11,600 shares of Series E Convertible Preferred
Stock, including accrued dividends, for 28,632 and 41,604 shares of common stock,
respectively. During the three and nine month periods ended December 31, 2008, certain
preferred shareholders converted 3,600 and 4,400 shares of Series E Convertible Preferred
Stock, including accrued dividends, for 15,232 and 18,267 shares of common stock,
respectively.
On December 13, 2008, the Companys board of directors approved the conversion of all
outstanding Series E Convertible Preferred Stock into common stock and the Company sent a
notice of redemption to all holders of Series E Convertible Preferred Stock to convert the
remaining 94,200 shares of Series E Convertible Preferred Stock and any accrued and unpaid
dividends into 470,965 shares of common stock plus cash for any fractional shares of common
stock. As a result of this mandatory conversion as set forth in the Series E Convertible
Preferred Certificate of Designation, there are no outstanding shares of Series E
Convertible Preferred Stock at December 31, 2008.
The Company could have, at any time, required that any or all outstanding shares of Series E
Convertible Preferred Stock be converted into shares of our common stock, provided that the
shares of common stock into which the Series E Convertible Preferred Stock were convertible
were registered pursuant to an effective registration statement, as defined. The number of
shares of common stock received by the holders of the Series E Convertible Preferred Stock
upon the mandatory conversion by us would have been determined by (i) dividing the
Liquidation Price E by the Conversion Price E provided that the closing bid price for the
Companys common stock exceeded $10.56 for 20 out of 30 consecutive trading days within 180
days prior to notice of conversion, as defined, or (ii) if the requirements of (i) were not
met, the number of shares of common stock was determined by dividing 110% of the Liquidation
Price E by the Conversion Price E. The Conversion Price E was subject to certain
adjustments, as defined in the Certificate of Designation.
The Series E Convertible Preferred Stock had a preference in liquidation equal to $25.00 per
share, plus any accrued and unpaid dividends, over the common stock and was parri passu with
all other outstanding series of preferred stock. Each issued and outstanding share of Series
E Convertible Preferred Stock was entitled to 3.5511 votes (subject to adjustment) with
respect to any and all matters presented to the Companys stockholders for their action or
consideration. Except as provided by law or by the provisions establishing any other series
of preferred stock, Series E Convertible Preferred
stockholders and holders of any other outstanding preferred stock voted together with the
holders of common stock as a single class.
-19-
Common Stock No common stock other than through the exercise of options, dividends on
preferred shares or conversion of preferred shares was issued in the three and nine month
periods ended December 31, 2007 and 2008.
Warrants During the three and nine month periods ended December 31, 2007, warrants to
purchase 30,000 and 78,312 shares of common stock were exercised, resulting in proceeds to
the Company of $187,200 and $482,937, respectively. During the three and nine month periods
ended December 31, 2008, there were no warrants exercised.
In connection with services rendered to the Company, effective July 17, 2007, the Company
issued to an investor relations firm, warrants to purchase 30,000 shares of common stock.
The warrants are exercisable at $9.00 per share. The warrants are exercisable through July
17, 2011 as follows: (i) 10,000 vest immediately, (ii) 10,000 vest upon the Companys stock
trading at or above $10.00 per share for 20 consecutive trading days and (iii) 10,000 vest
upon the Companys stock trading at or above $12.00 per share for 20 consecutive trading
days. The warrants have been expensed using a grant date value as calculated using the
Black-Scholes valuation model of approximately $118,000.
In connection with a consulting agreement, the Company issued warrants on September 10, 2007
to purchase 50,000 shares of common stock. The warrants are exercisable at $10.00 per
share. The warrants are exercisable through September 10, 2010. The warrants have been
expensed using a grant date value as calculated using the Black-Scholes valuation model of
approximately $172,000.
Incentive Stock Programs At the stockholders meeting held November 12, 2004, the
stockholders approved the second amendment to the 2000 Stock Incentive Plan which increased
the number of shares of common stock reserved for issuance from 1,100,000 to 2,200,000. At
the stockholders meeting held November 29, 2007, the stockholders approved the 2007 Stock
Incentive Plan which increased the number of shares of common stock reserved for issuance by
an additional 1,500,000 shares. Options granted under the 2000 and 2007 Stock Incentive
Plans that expire are available to be reissued. During the nine month periods ended
December 31, 2007 and 2008, 83,746 and 161,500 options, respectively, previously granted
under the 2000 and 2007 Stock Incentive Plans expired and were available to be reissued.
During the three and nine month periods ended December 31, 2007, the Company issued 312,650
options to purchase shares of common stock. During the three and nine month periods ended
December 31, 2008, no options were granted. As of December 31, 2008, there were a total of
1,754,774 shares of common stock available for grant. The purchase price of shares must be
at least equal to the fair market value of the common stock on the date of grant, and the
maximum term of an option is 10 years. The options generally vest over periods ranging from
0 to 3 years.
-20-
The Company recognized approximately $725,000 and $1,829,000 of compensation cost for the
three and nine month periods ended December 31, 2007, and approximately
$199,000 and $803,000 for the three and nine month periods ended December 31, 2008. The
cumulative compensation cost for the nine month period ended December 31, 2008 was offset by
a credit of approximately $609,000 due to the change in forfeiture rate reported in the
three months ended June 30, 2008. During the three month period ended December 31, 2007,
7,000 options were exercised on a cashless basis resulting in 4,254 common shares being
issued, and 972 options were exercised with an exercise price of $2.55, resulting in
proceeds to the Company of approximately $2,479 while during the nine month period ended
December 31, 2007, 26,119 options were exercised on a cashless basis resulting in 22,254
common shares being issued and 972 options were exercised resulting in proceeds of
approximately $2,479. During the nine month period ended December 31, 2008, 11,387 options
were exercised on a cashless basis resulting in 4,931 common shares being issued.
The fair value of each stock option award is estimated on the date of grant using the
Black-Scholes valuation model. The Company uses historical data regarding stock option
exercise behaviors to estimate the expected term of options granted (based on the period of
time that options granted are expected to be outstanding). Expected implied volatility is
based on the volatility of the Companys exchange traded options for the Companys common
stock. The risk-free interest rate is based on the U.S. treasury security rate in effect
over the estimated life of the option. There is no dividend yield. The following
weighted-average assumptions were used in calculating the fair value of stock options
granted during the three and nine month periods ended December 31, 2007 and 2008.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Risk free interest rate |
|
|
4.25 |
% |
|
|
|
|
|
|
4.41 |
% |
|
|
|
|
Average life of options (years) |
|
|
10.0 |
|
|
|
|
|
|
|
10.0 |
|
|
|
|
|
Volatility |
|
|
62 |
% |
|
|
|
|
|
|
67 |
% |
|
|
|
|
Dividend yield |
|
|
0 |
|
|
|
|
|
|
|
0 |
|
|
|
|
|
A summary of stock option activity as of and for the nine month period ended December 31,
2008, is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
|
|
|
|
|
Exercise |
|
|
Contractual |
|
|
|
|
|
|
|
Price Per |
|
|
Term(*) in |
|
|
|
Shares |
|
|
Share (*) |
|
|
Years |
|
Outstanding at March 31, 2008 |
|
|
2,098,113 |
|
|
$ |
8.53 |
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(11,387 |
) |
|
|
.46 |
|
|
|
|
|
Forfeited or expired |
|
|
(216,990 |
) |
|
|
7.74 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2008 |
|
|
1,869,736 |
|
|
|
8.68 |
|
|
|
6.34 |
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2008 |
|
|
1,724,464 |
|
|
|
8.86 |
|
|
|
6.13 |
|
|
|
|
|
|
|
|
|
|
|
-21-
The weighted-average grant date fair value of options granted during the nine month periods
ended December 31, 2007 and 2008 was $6.57 and $0, respectively. The intrinsic value of
options exercised during the nine month periods ended December 31, 2007 and
2008 was approximately $174,000 and $7,000, respectively. The intrinsic value of stock
options outstanding at the nine month periods ended December 31, 2007 and 2008 was
approximately $347,000 and $0, respectively.
As of December 31, 2008, there was approximately $473,000 of unrecognized compensation cost
related to non-vested stock option compensation arrangements granted under the 2000 and 2007
Plans that are expected to be recognized as a charge to operations over a weighted-average
period of 0.5 years. As of December 31, 2008, 1,820,344 options have vested or are expected
to vest with a weighted-average exercise price of $8.73, a weighted-average remaining life
of 6.27 years, and with an intrinsic value of $0.
4. |
|
COLLABORATIVE RESEARCH AND DEVELOPMENT ACTIVITIES |
The Company earns revenue under various collaborative research agreements. Under the terms
of these arrangements, the Company generally has agreed to perform best efforts research and
development and, in exchange, the Company may receive advanced cash funding, an allowance
for management overhead, and may also earn additional fees for the attainment of certain
milestones.
The Company initially acquired its rights to the aromatic cation technology platform
developed by a consortium of universities consisting of UNC-CH, Georgia State, Duke
University and Auburn University pursuant to an agreement, dated January 15, 1997 (as
amended, the Consortium Agreement) among the Company, UNC-CH and a third-party (to which
each of the other members of the scientific consortium shortly thereafter joined) (the
original licensee). The Consortium Agreement commits the parties to collectively research,
develop, finance the research and development of, manufacture and market both the technology
and compounds owned by the scientific consortium and previously licensed or optioned to the
original licensee and licensed to the Company in accordance with the Consortium Agreement
(the Current Compounds), and all technology and compounds developed by the scientific
consortium after January 15, 1997, through use of Company-sponsored research funding or
National Cooperative Drug Development grant funding made available to the scientific
consortium (the Future Compounds and, collectively with the Current Compounds, the
Compounds).
The Consortium Agreement contemplated that upon the completion of our initial public
offering (IPO) of shares of common stock with gross proceeds of at least $10,000,000 by
April 30, 1999, the Company, with respect to the Current Compounds, and UNC-CH, (on behalf
of the Scientific Consortium), with respect to Current Compounds and Future Compounds, would
enter into license agreements for the intellectual property rights relating to the Compounds
pursuant to which the Company would pay royalties and other payments based on revenues
received for the sale of products based on the Compounds.
The Company completed an IPO on April 26, 1999, with gross proceeds in excess of $10,000,000
thereby earning a worldwide license and exclusive rights to commercially use, manufacture,
have manufactured, promote, sell, distribute, or otherwise dispose of any products based
directly or indirectly on all of the Compounds.
-22-
As a result of the closing of the IPO, the Company issued an aggregate of 611,250 shares of
common stock, of which 162,500 shares were issued to the Scientific Consortium and 448,750
shares were issued to the original licensee or persons designated by the original licensee.
As contemplated by the Consortium Agreement, on January 28, 2002, the Company entered into a
license agreement with the Scientific Consortium whereby the Company received the exclusive
license to commercialize the aromatic cation technology platform and compounds developed or
invented by one or more of the Consortium scientists after January 15, 1997 (the License
Agreement), and which also incorporated into such License Agreement the Companys existing
license with the Scientific Consortium with regard to the Current Compounds. Also pursuant
to the Consortium Agreement, the original licensee transferred to the Company the worldwide
license and exclusive right to commercially use, manufacture, have manufactured, promote,
sell, distribute or otherwise dispose of any and all products based directly or indirectly
on aromatic cations developed by the Scientific Consortium on or prior to January 15, 1997
and previously licensed (together with related technology and patents) to the third-party.
The Consortium Agreement provides that the Company is required to pay to UNC-CH on behalf of
the Scientific Consortium reimbursement of patent and patent-related fees, certain milestone
payments and royalty payments based on revenue derived from the Scientific Consortiums
aromatic cation technology platform. Each month on behalf of the inventor scientist or
university, as the case may be, UNC-CH submits an invoice to the Company for payment of
patent-related fees related to current compounds or future compounds incurred prior to the
invoice date. The Company is also required to make milestone payments in the form of the
issuance of 100,000 shares of its common stock to the Consortium when it files its first
initial New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) based
on Consortium technology. The Company is also required to pay to UNC-CH on behalf of the
Scientific Consortium (other than Duke University) (i) royalty payments of up to 5% of our
net worldwide sales of current products and future products (products based directly or
indirectly on current compounds and future compounds, respectively) and (ii) a percentage of
any fees the Company receives under sublicensing arrangements. With respect to products or
licensing arrangements emanating from Duke University technology, the Company is required to
negotiate in good faith with UNC-CH (on behalf of Duke University) royalty, milestone or
other fees at the time of such event, consistent with the terms of the Consortium Agreement.
Under the License Agreement, the Company must also reimburse the cost of obtaining patents
and assume liability for future costs to maintain and defend patents so long as the Company
chooses to retain the license to such patents.
-23-
During the three and nine month periods ended December 31, 2008, the Company expensed
approximately $32,000 and $199,000, respectively, of other payments to UNC-CH and certain
other Scientific Consortium universities for patent related costs and other contracted
research. For the corresponding periods ended December 31, 2007, the Company expensed
approximately $180,000 and $583,000, respectively. Included in
accounts payable as of December 31, 2008 and March 31, 2008, were approximately $269,000,
and $755,000, respectively, due to UNC-CH and certain other Scientific Consortium
universities.
In November 2000, The Bill & Melinda Gates Foundation (Foundation) awarded a $15,114,000
grant to UNC-CH (the Foundation Grant) to develop new drugs to treat human Trypanosomiasis
(African sleeping sickness) and leishmaniasis. On March 29, 2001, UNC-CH entered into a
clinical research subcontract agreement with the Company, whereby the Company was to receive
up to $9,800,000, subject to certain terms and conditions, over a five year period to
conduct certain clinical and research studies related to the Foundation Grant.
In April 2003, the Foundation awarded a supplemental grant of approximately $2,700,000 to
UNC-CH for the expansion of phase IIB/III clinical trials to treat African sleeping sickness
and improved manufacturing processes. The Company has received, pursuant to the clinical
research subcontract with UNC-CH, inclusive of its portion of the supplemental grant, a
total amount of funding of approximately $11,700,000. Grant funds paid in advance of the
Companys delivery of services are treated as restricted funds and must be segregated from
other funds and used for the purposes specified. In March 2006, the Company amended and
restated the clinical research subcontract with UNC-CH, and UNC-CH in turn obtained an
expanded funding commitment for the Company of approximately $13,601,000 from the
Foundation. Under the amended and restated agreement, the Company received on May 24, 2006
the first payment of approximately $5,649,000 of the five year approximately $13,601,000
contract. On November 2, 2007, the Company received a second payment of approximately
$5,123,000 from the Consortium.
During the three and nine months ended December 31, 2008, approximately $408,000 and
$1,920,000 was utilized for clinical and research purposes conducted and expensed,
respectively. During the three and nine months ended December 31, 2007, approximately
$1,335,000 and $2,639,000 was utilized for clinical and research purposes conducted and
expensed, respectively. The Company has recognized revenues of approximately $563,000 and
$2,076,000 during the three and nine months ended December 31, 2008, respectively. The
Company has recognized revenues of approximately $1,335,000 and $2,639,000 during the three
and nine months ended December 31, 2007, respectively. The remaining amount (approximately
$173,000 as of December 31, 2008) has been deferred and will be recognized as revenue over
the term of the agreement as the services are performed.
On June 8, 2007, the Company entered into an exclusive licensing agreement pursuant to which
the Company licensed to Par Pharmaceutical Companies, Inc. (Par) commercialization rights
in the U.S. to pafuramidine for the treatment of pneumocystis pneumonia (PCP) in AIDS
patients (Par License Agreement). Under the Par License Agreement, the Company and Par
also contemplated collaborating on efforts to develop pafuramidine as a preventative therapy
for patients at risk of developing PCP, including people living with HIV, cancer and other
immunosuppressive conditions.
-24-
In return, the Company received an initial payment of $3 million. Par was to also pay the
Company as much as $29 million in development milestones if pafuramidine advanced through
ongoing Phase III clinical trials and the United States Food and Drug Administration (FDA)
regulatory review and approval. In addition to royalties on sales, the Company could have
received up to $115 million in additional milestone payments on future sales and retain the
right to co-market pafuramidine in the U.S. The Company granted Par a right of first offer
to enter into a license agreement with it if the Company determined that pafuramidine could
be used for the treatment and/or prophylaxis of malaria. As a result of the discontinuation
of the pafuramidine program, the Company recognized approximately $0 and $68,000 of deferred
income in the three and nine month periods ended December 31, 2008, respectively. The Par
License Agreement was terminated by Par on May 9, 2008.
On December 3, 2007, the Company entered into a licensing agreement with BioAlliance Pharma
SA (BioAlliance) pursuant to which the Company granted Bio-Alliance and its affiliates an
exclusive license to commercialize pafuramidine in Europe for the treatment of PCP in AIDS
patients and African sleeping sickness (BioAlliance License Agreement). The Company also
granted BioAlliance an option to commercialize pafuramidine in Europe for the prevention and
treatment of malaria in travelers. Pursuant to the BioAlliance License Agreement, the
Company received an initial payment of $3 million from BioAlliance, and it was to have
received an additional $13 million upon achieving certain regulatory and pricing milestones.
In addition, the Company was to receive an additional $10 million upon achieving certain
sales milestones and was to have received double-digit royalties based on sales. As a
result of the discontinuation of the pafuramidine program, the Company recognized
approximately, $0 and $67,000 of deferred income in the three and nine month periods ended
December 31, 2008. The Company will not receive additional funds.
On December 20, 2007, the FDA informed the Company that it had placed all of the Companys
ongoing and projected clinical trials relating to the development of pafuramidine on
clinical hold. Subsequently the program was discontinued on February 22, 2008.
In October 2003, Gerhard Von der Ruhr and his son Mark (the Von der Ruhr Plaintiffs)
filed a complaint in the United States District Court for the Northern District of Illinois
against the Company and certain officers and directors alleging breaches of a stock lock-up
agreement, option agreements and a technology license agreement by the Company. The Von de
Ruhr Plaintiffs also alleged a claim for intentional interference with contractual relations
by certain officers of the Company. The complaint sought unspecified monetary damages and
punitive damages, in addition to equitable relief and costs. In a filing made in late
February 2005, the Von der Ruhr Plaintiffs specified damages of approximately $44.5 million
in damages.
-25-
In 2005, one of the breach of contract claims was dismissed upon the Companys motion for
summary judgment. On October 26, 2006, a preliminary pre-trial conference was
held and the court granted the Companys motions in limine to exclude plaintiffs damage
claim for lost profits and prohibited plaintiff from offering expert testimony at trial on
this issue. The court subsequently granted a motion to sever the trial on Count V,
regarding the technology license agreement, from the trial on the remaining counts. The
trial on the remaining counts concluded on December 7, 2007, and a jury returned a verdict
against the Company and certain officers and directors for a total amount of $361,705. The
Company immediately filed a motion with the court seeking to overturn the jury verdict,
which the court subsequently denied. The Company had accrued for the litigation settlement
in full, of which $120,000 was paid by the Company during the first quarter of fiscal 2009.
The remaining amount is included in accrued liabilities at December 31, 2008.
In the first quarter of 2008, the Von der Ruhr Plaintiffs appealed the trial courts ruling
excluding their damage claim for lost profits. Separately, the Companys officers and
directors have appealed the jurys finding on the intentional interference with contractual
relations claim. The United States Court of Appeals for the Seventh Circuit has
consolidated these appeals, and briefing to the appellate court was completed on October 17,
2008. Oral argument in the consolidated appeals was held on January 16, 2009. The appeals
are now pending decision before the appellate court.
On January 12, 2009, Immtech Hong Kong Limited (Immtech HK) and Super Insight Limited
(Super Insight) (collectively, the Vendors), Immtech Life Science Limited (Immtech
Life) and Chen Jian Yuan (the Purchaser) entered into a Sale and Purchase Agreement (the
Sale and Purchase Agreement), pursuant to which the Purchaser purchased all of the issued
share capital of Immtech Life, a subsidiary, whose sole asset was land use rights in
Shenzhen, China, wholly owned indirectly by the Company.
Under the terms of the Sale and Purchase Agreement, (i) the Vendors have agreed to sell and
Purchaser has agreed to purchase 100 issued ordinary shares of Immtech Life (the Sale
Shares) and (ii) Super Insight has agreed to assign the shareholders loan due from Immtech
Life to Super Insight (the Shareholders Loan) to the Purchaser. The total consideration
for the Sale Shares and the Shareholders Loan is $2,000,000. The Vendors received the
initial payment of $600,000 on January 12, 2009. The remaining $1,400,000 is required to be
paid on or before March 19, 2009.
-26-
|
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|
Item 2. |
|
Managements Discussion and Analysis of Financial Condition and Results
of Operations. |
Forward Looking Statements
Certain statements contained in this quarterly report and in the documents incorporated by
reference herein constitute forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements other than statements of historical fact
may be deemed to be forward-looking statements. Forward-looking statements frequently, but not
always, use the words may, intends, plans, believes, anticipates or expects or similar
words and may include statements concerning our strategies, goals and plans. Forward-looking
statements involve a number of significant risks and uncertainties that could cause our actual
results or achievements or other events to differ materially from those reflected in such
forward-looking statements. Such factors include, among others described in this quarterly report,
the following: (i) we are in an early stage of product development, (ii) the possibility that
favorable relationships with collaborators cannot be established or, if established, will be
abandoned by the collaborators before completion of product development, (iii) the possibility that
we or our collaborators will not successfully develop any marketable products, (iv) the possibility
that advances by competitors will cause our product candidates not to be viable, (v) uncertainties
as to the requirement that a drug product be found to be safe and effective after extensive
clinical trials and the possibility that the results of such trials, if completed, will not
establish the safety or efficacy of our drug product candidates, (vi) risks relating to
requirements for approvals by governmental agencies, such as the Food and Drug Administration,
before products can be marketed and the possibility that such approvals will not be obtained in a
timely manner or at all or will be conditioned in a manner that would impair our ability to market
our product candidates successfully, (vii) the risk that our patents could be invalidated or
narrowed in scope by judicial actions or that our technology could infringe upon the patent or
other intellectual property rights of third parties, (viii) the possibility that we will not be
able to raise adequate capital to fund our operations through the process of commercializing a
successful product or that future financing will be completed on unfavorable terms, (ix) the
possibility that any products successfully developed by us will not achieve market acceptance and
(x) other risks and uncertainties that may not be described herein. We undertake no obligation to
update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Results of Operations
With the exception of certain research funding agreements, license agreements and certain grants,
we have not generated any revenue from operations. For the period from inception (October 15,
1984) to December 31, 2008, we incurred cumulative net losses of approximately $112,172,000. We
have incurred additional losses since such date and we expect to incur additional operating losses
for the foreseeable future. We expect that our cash sources for at least the next year will be
limited to:
|
|
|
payments from foundations and other collaborators under arrangements that
may be entered into in the future; |
|
|
|
payments from license agreement milestones; |
|
|
|
grants from the United States government and other governments and entities;
and |
|
|
|
the issuance of securities or borrowing of funds and future proceeds from
the sale of the land use rights in Shenzhen, China. |
-27-
The timing and amounts of grant and payment revenues, if any, will likely fluctuate sharply and
depend upon the achievement of specified milestones, and results of operations for any period may
be unrelated to the results of operations for any other period.
Three Month Period Ended December 31, 2008 Compared with the Three Month Period Ended December 31,
2007.
Revenues under collaborative research and development, and license agreements were approximately
$563,000 and $1,835,000 for the three month periods ended December 31, 2008 and December 31, 2007,
respectively. For the three month period ended December 31, 2008, we recognized revenues of
approximately $563,000 related to a clinical subcontract agreement between us and UNC-CH while for
the three month period ended December 31, 2007, we recognized revenues of approximately $1,335,000
related to the abovementioned UNC-CH clinical research subcontract, approximately $387,000 related
to the Par License Agreement, and approximately $113,000 related to the BioAlliance License
Agreement.
Grant and research and development agreement revenue is recognized as completed under the terms of
the respective agreements, according to Company estimates. Grant and research and development
funds received prior to completion under the terms of the respective agreements are recorded as
deferred revenues.
Revenue from licensing arrangements is recorded when earned based on the performance requirements
of the contract. Nonrefundable upfront license fees, for product candidates where the Company is
providing continuing services related to product development, are deferred and recognized as
revenue over the development period or as the Company provides services required under the
agreement. The timing and amount of revenue the Company recognizes from licenses, either from
upfront fees or milestones where the Company is providing continuing services related to product
development, is dependent upon the Companys estimates of filing dates.
Research and development expenses decreased to approximately $734,000 from $4,214,000 for the three
month periods ended December 31, 2008 and December 31, 2007, respectively. This is primarily due
to the discontinuation of the drug development program for pafuramidine. Research and development
expenses relating to the UNC-CH subcontract, decreased to approximately $408,000 in the three month
period ended December 31, 2008 from approximately $1,335,000 in the three month period ended
December 31, 2007. Discovery contract research expenses decreased to approximately $121,000 in the
three month period ended December 31, 2008 from approximately $473,000 in the period ended December
31, 2007. Contract services relating to malaria trials decreased to approximately $69,000 in the
three month period ended December 31, 2008 from approximately $369,000 in the three month period
ended December 31, 2007. Additionally, contract services relating to trials for treatment of PCP
decreased to approximately $12,000 from approximately $1,438,000 in the same periods.
-28-
Expenses associated with maintaining operations in mainland China were approximately $86,000 for
the three month period ended December 31, 2008. Non-cash options expense under research and
development decreased to approximately $51,000 in the three month period ended December 31, 2008
from approximately $136,000 in the three month period ended December 31, 2007. Other research and
development expenses, which include the effect of headcount reduction year over year, decreased
approximately $476,000 from the three month period ended December 31, 2007 to the three month
period ended December 31, 2008.
General and administrative expenses decreased to approximately $1,211,000 from approximately
$2,926,000 during the three month periods ended December 31, 2008 and December 31, 2007,
respectively. The decrease was largely due to legal and accounting costs, which decreased to
approximately $66,000 in the three month period ended December 31, 2008, from approximately
$665,000 in the three month period ended December 31, 2007, along with the booking of approximately
$362,000 as a reserve in the period ended December 31, 2007 for the settlement of the Von der Ruhr
litigation. Non-cash general and administrative expenses decreased to approximately $149,000 in
the three month period ended December 31, 2008, from approximately $588,000 in the three month
period ended December 31, 2007, which relates to expensing of options. Costs relating to the
formation of a new affiliated entity were approximately $290,000 in the three month period ended
December 31, 2008. The entity is currently in the process of raising capital for investment
purposes. The Company expects to own a minority interest in the entity.
During the three month period ended December 31, 2008, the company recorded a non-cash asset
impairment charge of approximately $504,000 relating to the land use rights which have been
subsequently sold for $2,000,000.
Our net loss decreased to approximately $1,883,000 from approximately $5,204,000 during the three
month periods ended December 31, 2008 and December 31, 2007, respectively.
Nine Month Period Ended December 31, 2008 Compared with the Nine Month Period Ended December 31,
2007.
Revenues under collaborative research and development agreements were approximately $2,210,000 and
$3,692,000 for the nine month periods ended December 31, 2008 and December 31, 2007, respectively.
For the nine month period ended December 31, 2008, we recognized revenues of approximately
$2,076,000 related to a clinical research subcontract agreement between us and UNC-CH,
approximately $67,000 related to the Par License Agreement, and approximately $67,000 related to
the BioAlliance License Agreement while for the nine month period ended December 31, 2007,
recognized revenues of approximately $2,639,000 related to the abovementioned UNC-CH clinical
research subcontract agreement, approximately $940,000 related to the Par License Agreement, and
approximately $113,000 related to the BioAlliance License Agreement.
Grant and research and development agreement revenue is recognized as completed under the terms of
the respective agreements, according to Company estimates. Grant and research and development
funds received prior to completion under the terms of the respective agreements are recorded as
deferred revenues.
-29-
Revenue from licensing arrangements is recorded when earned based on the performance requirements
of the contract. Nonrefundable upfront license fees, for product candidates where the Company is
providing continuing services related to product development, are deferred and recognized as
revenue over the development period or as the Company provides services required under the
agreement. The timing and amount of revenue the Company recognizes from licenses, either from
upfront fees or milestones where the Company is providing continuing services related to product
development, is dependent upon the Companys estimates of filing dates.
Research and development expenses decreased to approximately $3,218,000 from $8,415,000 for the
nine month periods ended December 31, 2008 and December 31, 2007, respectively. This is primarily
due to the discontinuation of the drug development program for pafuramidine. Research and
development expenses relating to the UNC-CH subcontract, decreased to
approximately $1,916,000 in
the nine month period ended December 31, 2008 from approximately $2,556,000 in the nine month
period ended December 31, 2007. Discovery contract research expenses decreased to approximately
$528,000 in the nine month period ended December 31, 2008 from approximately $1,079,000 in the
period ended December 31, 2007. Contract services relating to malaria trials decreased to
approximately $173,000 in the nine month period ended December 31, 2008 from approximately
$1,151,000 in the nine month period ended December 31, 2007. Additionally, contract services
relating to trials for treatment of PCP and the subsequent termination decreased to approximately
$251,000 from approximately $2,233,000 in the same periods. Expenses associated with setting up
and maintaining operations in mainland China were approximately $252,000 in the nine month period
ended December 31, 2008. Non-cash options expense under research and development decreased to
approximately $30,000 in the nine month period ended December 31, 2008 from approximately $369,000
in the nine month period ended December 31, 2007.
General and administrative expenses decreased to approximately $3,404,000 from approximately
$6,858,000 during the nine month periods ended December 31, 2008 and December 31, 2007,
respectively. Patent fees decreased to approximately $199,000 in the nine month period ended
December 31, 2008 from approximately $299,000 in the nine month period ended December 31, 2007.
Legal and accounting fees decreased to approximately $423,000 in the nine month period ended
December 31, 2008 from approximately $1,116,000 in the nine month period ended December 31, 2007,
along with the booking of approximately $362,000 as a reserve in the period ended December 31, 2007
for the settlement of the Von der Ruhr litigation. Public relations decreased to approximately
$92,000 in the nine month period ended December 31, 2008 from approximately $540,000 in the nine
month period ended December 31, 2007. Non-cash general and administrative expenses decreased to
approximately $164,000 in the nine month period ended December 31, 2008, having benefited by a
reversal of approximately $428,000 due to the change in the option forfeiture rate under SFAS No.
123(R) upon the reduction in personnel in the first quarter of the fiscal year, from approximately
$1,749,000 in the nine month period ended December 31, 2007, which includes (i) approximately
$172,000 for the 50,000 warrants issued to a consultant, (ii) approximately $118,000 for the 30,000
warrants issued to an investor relations firm, and (iii) approximately $1,459,000 for expensing
options. Costs relating to the formation of a new affiliated entity were approximately $290,000 in
the nine month period ended December 31, 2008. The entity is currently in the process of raising
capital for investment purposes. The Company expects to own a minority interest in the entity.
-30-
During the nine month period ended December 31, 2008, the company recorded a non-cash asset
impairment charge of approximately $1,197,000 relating to the land use rights which have been
subsequently sold for $2,000,000.
Our net loss decreased to approximately $5,574,000 from approximately $11,199,000 during the nine
month periods ended December 31, 2008 and December 31, 2007, respectively.
Business Plans
AQ-13 and Other Infectious Diseases Programs
Our clinical and regulatory staff is planning for the clinical development of AQ-13 for the
treatment of malaria and malaria prophylaxis in travelers. We have identified and are preparing to
execute additional toxicology and genotoxicology studies, and planning the Phase I dose ranging
study of AQ-13. We recently received an Orphan Drug Designation for AQ-13 in treatment of malaria,
and have licensed exclusive rights to AQ-13 and other 4-aminoquinolines in development from Tulane
University. We are currently pursuing relationships with Non Governmental Organizations (NGOs)
and foundations to provide support for the development of AQ-13. We do not believe that we will
develop this program unless we obtain third party funding to cover or reduce third party and
overhead expenses. We expect to initiate the AQ-13 program in the first half of calendar year
2009.
We are also currently in discussions with commercial pharmaceutical organizations and NGOs
regarding providing services related to the clinical development of proprietary compounds for
infectious diseases on a fee-for-services basis. We believe that such arrangements will result in
positive cash flow and help to reduce overall ongoing operational expenses.
Discovery Programs
We are actively working on the following long term discovery programs currently supported by
Company funds:
Hepatitis C Virus (HCV): Through a combination of academic collaboration and contract services,
we are advancing an HCV drug discovery effort. In June 2008, we announced that a prototype
compound was found to have activity against HCV under assay conditions designed to demonstrate
inhibition of the virus entry process. We are currently engaged in new medicinal chemistry and
screening efforts to optimize the lead for potency and oral availability.
West Nile and Dengue Fever: Our understanding of mechanism of action of these compounds has led us
to investigate the application of our technology to inhibit the virus entry process of other
therapeutically important virus targets in the flavivirus family. Two notables in this family are
West Nile virus (WNV) and Dengue Fever virus. Screening efforts for WNV in particular have
caused us to identify a promising lead series which is currently undergoing lead optimization
through new medicinal chemistry.
-31-
The following programs are only being moved forward if third party funding is obtained:
Antifungal and Antibiotic: We are currently evaluating potential partnership opportunities for our
antifungal and antibiotic discovery programs. We have initiated discussions with potential
collaborators who may be interested in funding and executing additional discovery efforts in
exchange for future royalties or licensing rights.
China
Early this year, we announced the initiation of a collaboration with Beijing Capital Medical
University (BCMU) in Beijing, one of Chinas leading academic medical research centers. We plan
to explore the potential of having joint ventures with Chinese pharmaceutical companies that are
interested in expanding outside of China. These companies could provide funding and resources to
further develop our compounds.
Liquidity and Capital Resources
The accompanying financial statements have been prepared on a going concern basis, which
contemplates the realization of assets and the satisfaction of liabilities in the normal course of
business.
Since inception, the Company has incurred accumulated net losses of approximately $112,172,000.
Management expects the Company will continue to incur significant losses during the next several
years as the Company continues development activities, clinical trials and commercialization
efforts. In addition, the Company has various research and development agreements with third
parties and is dependent upon such parties abilities to perform under these agreements. There can
be no assurance that the Companys activities will lead to the development of commercially viable
products. The Companys operations to date have consumed substantial amounts of cash. The negative
cash flow from operations is expected to continue in the foreseeable future. The Company believes
it will require substantial additional funds to commercialize its drug candidates. The Companys
cash requirements may vary materially from those now planned when and if the following become
known: formation and development of relationships with strategic partners, changes in the focus
and direction of development programs, results of research and development efforts, results of
clinical testing, responses to grant requests, competitive and technological advances, requirements
in the regulatory process and other factors. Changes in circumstances in any results of our new
global business initiatives may require the Company to allocate substantially more funds than are
currently available or than management intends to raise.
As of December 31, 2008, cash and cash equivalents were approximately $914,000.
We spent approximately $3,000 and $7,000 on equipment purchases during the three and nine month
periods ended December 31, 2008, respectively. We spent approximately $5,000 on equipment purchases
during the three and nine month periods ended December 31, 2007. No significant purchases of
equipment are anticipated by us during the year ending March 31, 2009.
-32-
We periodically receive cash from the exercise of common stock options and warrants. No options or
warrants were exercised for cash during the three or nine month periods ended December 31, 2008.
During the three month period ended December 31, 2007, we received
approximately $187,000 from the exercise of warrants and approximately $2,000 from the exercise of
options. During the nine month period ended December 31, 2007, we received approximately $484,000
from the exercise of warrants and approximately $2,000 from the exercise of options.
We believe our existing unrestricted cash and cash equivalents and the future proceeds from the
sale of the land use rights in Shenzhen, China, will be sufficient to meet our planned expenditures
through at least June 30, 2009, although there can be no assurance we will not require additional
funds.
Through December 31, 2008, we financed our operations with:
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proceeds from various private placements of debt and equity securities, an
initial public offering, and other cash contributed from stockholders, which in
the aggregate raised approximately $77,608,000; |
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payments from research agreements, licensing agreements, foundation grants,
and Small Business Innovation Research (SBIR) grants and Small Business
Technology Transfer program grants of approximately $37,010,000; and |
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the use of stock, options and warrants in lieu of cash compensation. |
Our cash resources have been used to finance, develop and begin commercialization of drug product
candidates, including sponsored research, conducting human clinical trials, capital expenditures,
expenses associated with development of product candidates pursuant to the Consortium Agreement,
and, as contemplated by the Consortium Agreement, under the License Agreement with the Scientific
Consortium, and general and administrative expenses. Over the next several years we expect to incur
substantial additional research and development costs, including costs related to research in
pre-clinical (laboratory) and human clinical trials, administrative expenses to support our
research and development operations and marketing expenses to launch the sale of any commercialized
product that may be developed.
Our future working capital requirements will depend upon numerous factors, including the progress
of research, development and commercialization programs (which may vary as product candidates are
added or abandoned), results of pre-clinical testing and human clinical trials, achievement of
regulatory milestones, third party collaborators fulfilling their obligations to us, the timing and
cost of seeking regulatory approvals, the level of resources that we devote to the engagement or
development of manufacturing capabilities, our ability to maintain existing and to establish new
collaborative arrangements with others to provide funding to support these activities, and other
factors. In any event, we will require substantial additional funds in addition to our existing
resources to develop product candidates and to otherwise meet our business objectives.
We believe our existing unrestricted cash and cash equivalents and the grants and funds from the
sale of Immtech Life we have received or have been awarded and are awaiting disbursement of, will
be sufficient to meet our planned expenditures through at least June 2009, although there can be no
assurance we will not require additional funds.
-33-
Managements plans for the remainder of the fiscal year, in addition to normal operations, include
continuing their efforts to create joint ventures, obtain additional grants and to develop and
enter into research, development and/or commercialization agreements with others.
Item 3. Quantitative and Qualitative Disclosures about Market Risk.
The exposure of market risk associated with risk-sensitive instruments is not material, as our
operations are conducted primarily in U.S. dollars and we invest primarily in short-term government
obligations and other cash equivalents. We intend to develop policies and procedures to manage
market risk in the future if and when circumstances require. We have no off-balance sheet
arrangements as defined in Regulation S-K Item 303(a)(4)(ii).
The volatility and disruption of the capital and credit markets and adverse changes in the global
economy may negatively impact our business. Due to the existing uncertainty in the capital and
credit markets, our access to capital may not be available on terms acceptable to Immtech or at
all. Further, if adverse national and global economic conditions persist or worsen, we could
experience decreased shareholders equity, and have difficulty executing our business plans.
The adverse capital and credit market conditions could affect our liquidity. Adverse capital and
credit market conditions could affect our ability to meet liquidity needs, as well as our access to
capital and cost of capital. The capital and credit markets have been experiencing extreme
volatility and disruption for more than 12 months. In recent weeks, the volatility and disruption
have reached unprecedented levels and the markets have exerted downward pressure on availability of
liquidity and credit capacity for certain issuers. For example, recently credit spreads have
widened considerably. Our results of operations, financial condition, cash flows and capital
position could be materially adversely affected by continued disruptions in the capital and credit
markets.
Item 4. Controls and Procedures.
Disclosures and Procedures
We maintain controls and procedures designed to ensure that we are able to collect the information
we are required to disclose in the reports we file with the SEC, and to process, summarize and
disclose this information within the time periods specified in the rules of the SEC. Our chief
executive officer and chief financial officer are responsible for establishing and maintaining
these procedures and, as required by the rules of the SEC, evaluate their effectiveness. Based on
their evaluation of our disclosure controls and procedures, which took place as of the end of the
period covered by this Quarterly Report on Form 10-Q, our chief executive officer and chief
financial officer believe that these procedures are effective to ensure that we are able to
collect, process and disclose the information we are required to disclose in the reports we file
with the SEC within the required time periods.
-34-
Internal Controls
We maintain a system of internal controls designed to provide reasonable assurance that: (1)
transactions are executed in accordance with managements general or specific authorization and
(2) transactions are recorded as necessary to (a) permit preparation of financial statements in
conformity with generally accepted accounting principles and (b) maintain accountability for
assets. Access to assets is permitted only in accordance with managements general or specific
authorization and the recorded accountability for assets is compared with the existing assets at
reasonable intervals and appropriate action is taken with respect to any differences.
Changes in Internal Controls
There was no change in the Companys internal control over financial reporting that occurred during
the quarter ended December 31, 2008 that has materially affected, or is reasonably likely to
materially affect, the Companys internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings.
Gerhard Von der Ruhr et al. v. Immtech International, Inc. et. al.
In October 2003, Gerhard Von der Ruhr and his son Mark (the Von der Ruhr Plaintiffs) filed a
complaint in the United States District Court for the Northern District of Illinois against the
Company and certain officers and directors alleging breaches of a stock lock-up agreement, option
agreements and a technology license agreement by the Company. The Von de Ruhr Plaintiffs also
alleged a claim for intentional interference with contractual relations by certain officers of the
Company. The complaint sought unspecified monetary damages and punitive damages, in addition to
equitable relief and costs. In a filing made in late February 2005, the Von der Ruhr Plaintiffs
specified damages of approximately $44.5 million in damages.
In 2005, one of the breach of contract claims was dismissed upon the Companys motion for summary
judgment. On October 26, 2006, a preliminary pre-trial conference was held and the court granted
the Companys motions in limine to exclude plaintiffs damage claim for lost profits and prohibited
plaintiff from offering expert testimony at trial on this issue. The court subsequently granted a
motion to sever the trial on Count V, regarding the technology license agreement, from the trial on
the remaining counts. The trial on the remaining counts concluded on December 7, 2007, and a jury
returned a verdict against the Company and certain officers and directors for a total amount of
$361,705. The Company immediately filed a motion with the court seeking to overturn the jury
verdict, which the court subsequently denied.
In the first quarter of 2008, the Von der Ruhr Plaintiffs appealed the trial courts ruling
excluding their damage claim for lost profits. Separately, the Companys officers and directors
have appealed the jurys finding on the intentional interference with contractual relations claim.
The United States Court of Appeals for the Seventh Circuit has consolidated these appeals, and
briefing to the appellate court was completed on October 17, 2008. Oral argument in the
consolidated appeals was held on January 16, 2009. The appeals are now pending decision before the
appellate court.
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Item 1A. Risk Factors.
The business, results of operations and financial condition, and therefore the value of Immtechs
securities, are subject to a number of risks. Some of those risks are set forth in the Companys
annual report on Form 10-K for fiscal year ended March 31, 2008, filed with the U.S. Securities and
Exchange Commission on June 18, 2008. The following supplements the Companys discussion of risk
factors in the Companys annual report for the fiscal year ended March 31, 2008.
The volatility and disruption of the capital and credit markets and adverse changes in the global
economy may negatively impact our business.
Due to the existing uncertainty in the capital and credit markets, our access to capital may not be
available on terms acceptable to Immtech or at all. Further, if adverse national and global
economic conditions persist or worsen, we could experience decreased shareholders equity, and have
difficulty executing our business plans.
The adverse capital and credit markets could affect our liquidity.
Adverse capital and credit market conditions could affect our ability to meet liquidity needs, as
well as our access to capital and cost of capital. The capital and credit markets have been
experiencing extreme volatility and disruption for more than twelve months. In recent weeks, the
volatility and disruption have reached unprecedented levels and the markets have exerted downward
pressure on availability of liquidity and credit capacity for certain issuers. For example,
recently credit spreads have widened considerably. Our results of operations, financial condition,
cash flows and capital position could be materially adversely affected by continued disruptions in
the capital and credit markets.
Our shares of common stock may be de-listed from the NYSE Alternext US.
On December 23, 2008, we received a notice from the staff of the NYSE Alternext US (the Exchange)
that a review of our quarterly report on Form 10-Q for the period ended September 30, 2008
indicated that the we are not in compliance with certain of the Exchanges continued listing
standards as set forth in the Exchanges Company Guide (the Company Guide). The Exchange noted
that we are not in compliance with (a) Section 1003(a)(ii) of the Company Guide, because our
stockholders equity is less than $4,000,000 and we have had losses from continuing operations and
net losses in three out of our four most recent fiscal years; (b) Section 1003(a)(iii) of the
Company Guide, because our stockholders equity is less than $6,000,000 and we have had losses from
continuing operations and net losses in our five most recent fiscal years; and (c) Section
1003(a)(iv) of the Company Guide, because we have sustained losses which are so substantial in
relation to our overall operations or our existing financial resources, or our financial condition
has become so impaired that it appears questionable, in the opinion of the Exchange, as to whether
we will be able to continue operations and/or meet our obligations as they mature. We are required
to remedy each of these matters in a timely manner by submitting a plan advising the Exchange of
how we intend to regain compliance with Section 1003(a)(iv) of the Company Guide by March 23, 2009
and Sections 1003(a)(ii) and (iii) of the Company Guide by June 23, 2010. On January 23, 2009, we
submitted a plan to the Exchange addressing how we intend to regain compliance. If de-listing
occurs, it could be more difficult to buy or sell our
common stock and the price of our common stock could decline. Delisting could also affect our
ability to raise capital. If we were delisted from the Exchange, we could seek to move trading of
our common stock to the OTC Bulletin Board. This method of trading could significantly impair our
ability to raise new capital.
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Recent Sales of Unregistered Securities.
All such shares of common stock herein described as issuances below were made pursuant to Section
4(2) of the Securities Act of 1933, as amended.
Preferred Stock Dividend Payment.
On October 15, 2008, we issued 478,551 shares of common stock as payment of a dividend earned on
outstanding preferred stock to the holders thereof. Holders of Series A Convertible Preferred
Stock earned 48,777 shares of common stock on 32,500 outstanding shares; holders of Series B
Convertible Preferred Stock earned 18,938 shares of common stock on 9,464 outstanding shares;
holders of Series C Convertible Preferred Stock earned 91,126 shares of common stock on 45,536
outstanding shares; holders of Series D Convertible Preferred Stock earned 172,912 shares of common
stock on 115,200 outstanding shares; and holders of Series E Convertible Preferred Stock earned
146,798 shares of common stock on 97,800 outstanding shares. We also paid holders of our
outstanding preferred stock $26 in cash in lieu of fractional shares.
Conversion of Preferred Stock to Common Stock.
On December 1, 2008, holders of Series E Convertible Preferred Stock, $0.01 par value (Series E
Stock) converted 3,600 shares of Series E Stock into 15,232 shares of our common stock.
On December 13, 2008, holders of Series E Stock converted 94,200 shares of Series E Stock into
470,965 shares of our common stock under the mandatory conversion provisions as set forth in the
Certificate of Designation for the Series E Stock.
Item 3. Defaults Upon Senior Securities.
None
Item 4. Submission of Matters to a Vote of Security Holders.
None
Item 5. Other Information.
None
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Item 6. Exhibits.
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10.51**
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Sale and Purchase Agreement, dated January 12, 2009,
among Super Insight Limited, Immtech Hong Kong
Limited, Chen Jian Yuan, and Immtech Life Science
Limited (Form 8-K, dated January 12, 2009) |
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31.1*
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Certification by the Chief Executive Officer pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002 |
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31.2*
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Certification by the Chief Financial Officer pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002 |
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32.1*
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Certification by the Chief Executive Officer pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002 |
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32.2*
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Certification by the Chief Financial Officer pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002 |
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* |
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Filed herewith |
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** |
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These items are hereby incorporated by reference from the exhibits of the filing or report
indicated (except) where noted, (Commission File No. 001-14907) and are hereby made a part of this
Report. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
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IMMTECH PHARMACEUTICALS, INC.
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Date: February 9, 2009 |
By: |
/s/ Eric L. Sorkin
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Eric L. Sorkin |
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President and Chief Executive Officer |
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Date: February 9, 2009 |
By: |
/s/ Gary C. Parks
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Gary C. Parks |
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Treasurer, Secretary and Chief Financial Officer
(Principal Financial and Accounting Officer) |
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EXHIBIT INDEX
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Exhibit No. |
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Description |
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10.51
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** |
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Sale and Purchase Agreement, dated January 12, 2009, among
Super Insight Limited, Immtech Hong Kong Limited, Chen Jian
Yuan, and Immtech Life Science Limited (Form 8-K, dated
January 12, 2009) |
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31.1
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* |
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Certification by the Chief Executive Officer pursuant to
Section 302 of the Sarbanes-Oxley Act |
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31.2
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* |
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Certification by the Chief Financial Officer pursuant to
Section 302 of the Sarbanes-Oxley Act |
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32.1
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* |
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Certification by the Chief Executive Officer pursuant to
Section 906 of the Sarbanes-Oxley Act |
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32.2
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* |
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Certification by the Chief Financial Officer pursuant to
Section 906 of the Sarbanes-Oxley Act |
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* |
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Filed herewith |
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** |
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These items are hereby incorporated by reference from the exhibits of
the filing or report indicated (except) where noted, (Commission File
No. 001-14907) and are hereby made a part of this Report. |