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
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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
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For the transition period from
to
.
Commission file number 0-23280
NEUROBIOLOGICAL TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction of incorporation)
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94-3049219
(IRS Employer Identification No.)
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2000 Powell Street, Suite 800, Emeryville, California 94608
(Address of principal executive offices)
(510) 595-6000
(Registrants telephone number, including area code)
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, non-accelerated filer or a smaller reporting company. See definition
of accelerated filer, large 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
o
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Non-Accelerated Filer
o
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Smaller Reporting Company
þ
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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
Indicate the number of shares outstanding of each of the issuers classes of the common
stock, as of the latest practicable date.
Common Stock, $0.001 par value: 26,926,949 shares outstanding as of January 30, 2009.
NEUROBIOLOGICAL TECHNOLOGIES, INC.
FORM 10-Q
TABLE OF CONTENTS
2
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
NEUROBIOLOGICAL TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except per share amounts)
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December 31,
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June 30,
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2008
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2008
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(Unaudited)
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(Note 1)
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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6,914
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$
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27,941
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Short-term investments
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16,400
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2,039
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Accounts receivable
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200
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599
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Prepaid expenses and other current assets
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277
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280
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Total current assets
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23,791
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30,859
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Deposits
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85
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85
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Long-term investments
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8,876
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11,850
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Property and equipment, net
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132
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393
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$
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32,884
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$
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43,187
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LIABILITIES AND STOCKHOLDERS EQUITY
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Current liabilities:
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Accounts payable
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$
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366
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$
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628
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Accrued clinical trial expenses
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2,610
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1,075
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Accrued manufacturing and related expenses
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4,753
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581
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Accrued external research expenses, professional expenses and other liabilities
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803
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1,258
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Deferred revenue
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5,500
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5,500
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Total current liabilities
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14,032
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9,042
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Accrued clinical trial expenses and other liabilities
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567
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Deferred revenue, net of current portion
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10,542
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13,292
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Total liabilities
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24,574
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22,901
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Commitments and contingencies
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Stockholders equity:
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Preferred stock, $0.001 par value, 5,000 shares authorized; 3,000 authorized
shares designated as Series A convertible preferred stock, 2,332 shares issued
and 494 outstanding, with aggregate liquidation preference of $247
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247
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247
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Common stock, $0.001 par value, 50,000 shares authorized, 26,924 shares issued
and outstanding
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27
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27
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Additional paid-in capital
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145,588
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145,113
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Accumulated deficit
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(136,192
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)
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(125,591
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)
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Accumulated other comprehensive (loss) income
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(1,360
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)
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490
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Total stockholders equity
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8,310
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20,286
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$
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32,884
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$
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43,187
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See accompanying notes.
3
NEUROBIOLOGICAL TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited; in thousands, except per share amounts)
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Three months ended December 31,
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Six months ended December 31,
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2008
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2007
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2008
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2007
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REVENUES
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Royalty
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$
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2,007
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$
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2,103
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$
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4,085
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$
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4,084
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Technology sale and collaboration services
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1,484
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1,560
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2,971
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3,479
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Total revenues
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3,491
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3,663
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7,056
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7,563
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EXPENSES
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Research and development
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10,392
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7,416
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15,844
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12,877
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General and administrative
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1,201
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1,912
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2,532
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3,571
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Total expenses
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11,593
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9,328
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18,376
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16,448
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Operating loss
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(8,102
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)
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(5,665
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)
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(11,320
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)
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(8,885
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)
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Interest income
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264
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452
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513
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479
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Gain on sale of long-term investment
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170
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Interest expense, including non-cash amortization of discount
on notes of $1,748 and $2,336 for the three and six months
ended December 31, 2007, respectively.
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(1,847
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)
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(2,478
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)
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Non-cash gain on change in fair value of warrants
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177
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37
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3,079
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NET LOSS
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$
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(7,838
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)
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$
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(6,883
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)
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$
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(10,600
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)
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$
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(7,805
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)
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BASIC AND DILUTED NET LOSS PER SHARE
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$
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(0.29
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)
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$
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(0.36
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)
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$
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(0.39
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)
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$
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(0.65
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)
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Shares used in basic and diluted net loss per share calculation
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26,924
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19,313
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26,924
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12,042
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See accompanying notes.
4
NEUROBIOLOGICAL TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited in thousands)
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Six months ended
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December 31,
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2008
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2007
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OPERATING ACTIVITIES:
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Net loss
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$
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(10,600
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)
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$
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(7,805
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)
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Adjustments to reconcile net loss to net cash used in operating activities:
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Depreciation and amortization
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89
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103
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Loss on impairment of asset
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174
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Stock-based compensation
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474
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458
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Gain on sale of long-term investments
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(170
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)
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Non-cash gain on decrease in fair value of warrants
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(37
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)
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(3,079
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)
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Amortization of note discount
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2,336
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Changes in assets and liabilities:
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Accounts receivable
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399
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75
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Prepaid expenses and other current assets
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3
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622
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Accounts payable and accrued liabilities
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4,460
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(996
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)
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Deferred revenue
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(2,750
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)
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(2,750
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)
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Net cash used in operating activities
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(7,958
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)
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(11,036
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)
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INVESTING ACTIVITIES:
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Purchase of investments
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(19,356
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)
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(19,275
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)
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Maturity and sale of investments
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6,288
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2,165
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(Purchase) sale of property and equipment
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(2
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)
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2
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Net cash used in by investing activities
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(13,070
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)
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(17,108
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)
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FINANCING ACTIVITIES:
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Proceeds from exercise of stock options and purchases under the employee
stock purchase plan
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1
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30
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Proceeds from common stock issued in public offering, net of issuance costs
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54,896
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Proceeds from issuance of notes and common stock, net of issuance costs
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5,990
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Repayment of notes
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(6,000
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)
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Net cash provided by financing activities
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1
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54,916
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(Decrease) increase in cash and cash equivalents
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(21,027
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)
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|
26,772
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Cash and equivalents at beginning of period
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27,941
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|
|
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5,538
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Cash and equivalents at end of period
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$
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6,914
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|
$
|
32,310
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|
|
|
|
|
|
|
See accompanying notes.
5
NEUROBIOLOGICAL TECHNOLOGIES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2008
(Unaudited)
(Tabular amounts in thousands, except per share amounts, percentages and years)
1. Basis of Presentation and Summary of Significant Accounting Policies
Business Description
Neurobiological Technologies (NTI or the Company) is a biopharmaceutical company
historically focused on developing novel, first-in-class treatments for central nervous
system conditions and other serious unmet medical needs. The company recently terminated
development of its most advanced product candidate, Viprinex, which was studied in Phase
3 clinical trials for evaluation as a new drug to treat acute ischemic stroke. The
Company has the right to receive royalty payments from the sales of Namenda (memantine
HCL), an approved drug marketed for Alzheimers disease, and potential milestone and
royalty payments from the development of XERECEPT, an investigational drug which has
completed a Phase 3 clinical trial for the treatment of swelling associated with cerebral
tumors. Additionally, NTIs earlier stage pipeline includes rights to a protein in
preclinical development for the treatment of Alzheimers disease.
Basis of Presentation
The unaudited condensed consolidated financial statements include the accounts of
the Company and its wholly-owned subsidiary, NTI-Empire, Inc. All intercompany accounts
and transactions have been eliminated. NTI operates in one business segment, the
development of pharmaceutical products.
These financial statements have been prepared in accordance with U.S. generally
accepted accounting principles (GAAP) for interim financial information and with the
instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not
include all of the information and footnote disclosures required by GAAP for reporting on
complete financial statements. These condensed consolidated financial statements should
be read in conjunction with the financial statements and notes in the Companys Annual
Report on Form 10-K for the fiscal year ended June 30, 2008. The condensed consolidated
financial statements reflect all adjustments, which, in the opinion of management, are
necessary for a fair presentation of results for the interim periods presented. Such
adjustments consist only of normally recurring items. Operating results for the three-
and six-month periods ended December 31, 2008 are not necessarily indicative of the
results that may be expected for the fiscal year ending June 30, 2009.
The preparation of financial statements in conformity with GAAP requires management
to make estimates and assumptions that affect the balances and disclosures. Actual
results could differ from these estimates.
The consolidated balance sheet as of June 30, 2008 has been derived from the audited
financial statements at that date but as noted above does not include all disclosures
required for complete financial statements.
Revenue Recognition
Revenues are recognized according to the terms of contractual agreements to which
NTI is a party, when the Companys performance requirements have been fulfilled, the
amount is fixed and determinable, and collection is reasonably assured. Revenue from
license fees with non-cancelable, non-refundable terms and no future performance
obligations is recognized when collection is assured. Milestone payments are recognized
when the Company has fulfilled development milestones and collection is assured. Revenue
from services performed for other parties is recorded during the period in which the
expenses are incurred.
Royalty revenue is generally recorded when payments are received.
Revenue arrangements with multiple components are divided into separate units of
accounting if certain criteria are met, including whether the delivered component has
stand-alone value to the customer, and whether there is objective reliable evidence of
the fair value of the undelivered items. Consideration received is allocated among the
separate units of accounting based on their relative fair values, and the applicable
revenue recognition criteria are identified and applied to each of the units.
6
2. Investments
Available-for-sale securities were as follows:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31,
|
|
|
As of June 30,
|
|
|
|
2008
|
|
|
2008
|
|
|
|
|
|
|
|
Estimated
|
|
|
|
|
|
|
Estimated
|
|
|
|
Cost
|
|
|
Fair Value
|
|
|
Cost
|
|
|
Fair Value
|
|
Type of security and term
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate securities (ARS)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maturing in 22 to 37 years
|
|
$
|
10,252
|
*
|
|
$
|
8,876
|
|
|
$
|
11,372
|
*
|
|
$
|
11,850
|
|
Corporate debt obligations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maturing within one year
|
|
|
16,384
|
|
|
|
16,400
|
|
|
|
2,027
|
|
|
|
2,039
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total investments
|
|
$
|
26,636
|
|
|
$
|
25,276
|
|
|
$
|
13,399
|
|
|
$
|
13,889
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Classification
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term
|
|
|
|
|
|
$
|
16,400
|
|
|
|
|
|
|
$
|
2,039
|
|
Long-term
|
|
|
|
|
|
|
8,876
|
|
|
|
|
|
|
|
11,850
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total investments
|
|
|
|
|
|
$
|
25,276
|
|
|
|
|
|
|
$
|
13,889
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Cost represents purchase price less impairment charge of $1,598 and $1,768 on
securities still held at December 31, 2008 and June 30, 2008, respectively.
|
The Companys investments in auction rate securities (ARS) were structured to
provide liquidity via an auction process that resets the applicable interest rate at
predetermined calendar intervals. Beginning in February 2008, failed auctions occurred
throughout the ARS market, and since then all auctions for NTIs ARS have been
unsuccessful. While the credit rating of these securities remains high and the ARS are
paying interest according to their terms, as a result of the potentially long maturity
and lack of liquidity for ARS, the Company believes the value of the ARS in NTIs
portfolio has been impaired. During the fiscal year ended June 30, 2008, the Company
recorded an impairment charge to reduce the carrying value of the ARS. The impairment
charge was based on a model of discounted future cash flows and assumptions regarding
interest rates. The Company has also recorded an unrealized loss of $1,360,000 on its ARS
at December 31, 2008 based on a decrease in the estimated fair value since the impairment
charge was initially recorded. Due to recent wide and rapid fluctuations in the credit
markets, combined with the Companys low forecasted operating expenses in comparison to
its cash and investments balances, the Company believes the current fiscal year decline
in estimated market price for the ARS to be temporary. The Company believes it has the
ability to hold its ARS until recovery of the temporary decline in value. All other
unrealized gains and losses were immaterial. The Company has classified its ARS as
long-term at December 31, 2008, and all other investments are classified as short-term.
The following table shows additional information regarding the individual ARS held by the
Company:
|
|
|
|
|
|
|
|
|
|
|
As of December 31,
|
|
|
|
2008
|
|
|
|
Par
|
|
|
Estimated
|
|
|
|
Value
|
|
|
Fair Value
|
|
ARS
|
|
|
|
|
|
|
|
|
Brazos Texas Higher Ed. Authority
|
|
$
|
1,200
|
|
|
$
|
1,002
|
|
Kentucky Higher Ed. Student Loan Corporation
|
|
|
1,000
|
|
|
|
757
|
|
Mississippi Higher Ed. Assistance Corporation
|
|
|
1,800
|
|
|
|
1,411
|
|
Panhandle Plains Student Fin. Corporation
|
|
|
1,400
|
|
|
|
1,063
|
|
Pennsylvania St. Higher Ed. Assistance Agency
|
|
|
2,000
|
|
|
|
1,489
|
|
Vermont Student Assistant Loan Corporation
|
|
|
2,000
|
|
|
|
1,372
|
|
Others, none individually over $600 in estimated fair value
|
|
|
2,450
|
|
|
|
1,783
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
11,850
|
|
|
$
|
8,876
|
|
|
|
|
|
|
|
|
Custody of the Companys investments is held by Fidelity Investments. The majority of the
Companys cash and cash equivalents consist of commercial paper, which is also held in
custody at Fidelity Investments. Par value does not reflect the impairment charge.
7
3. Fair Value of Financial Instruments
Effective July 1, 2008, the Company adopted the provisions of Statement of Financial
Accounting Standards No. 157,
Fair Value Measurements
(SFAS 157), for financial assets
and liabilities and any other assets and liabilities carried at fair value. SFAS 157
establishes a valuation hierarchy for measurement of fair value. This hierarchy
prioritizes the inputs into levels of objectivity as follows:
|
|
Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities.
|
|
|
|
Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs
that are observable for the asset or liability, either directly or indirectly through market
corroboration, for substantially the full term of the financial instrument.
|
|
|
|
Level 3 inputs are unobservable inputs based on managements own assumptions used to measure assets
and liabilities at fair value, which are supported by little or no market activity.
|
A financial asset or liabilitys classification within the hierarchy is determined
based on the lowest level input that is significant to the fair value measurement. The
inputs or methodology used for valuing securities are not necessarily an indication of
credit risk associated with investing in those securities. The following table provides
the fair value measurements of our financial assets according to the fair value levels
defined by SFAS 157 as of December 31, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at December 31, 2008 Using
|
|
|
|
|
|
|
|
|
|
|
|
Level 2
|
|
|
|
|
|
|
Total Carrying
|
|
|
Level 1
|
|
|
Significant
|
|
|
Level 3
|
|
|
|
Value as of
|
|
|
Quoted prices
|
|
|
other
|
|
|
Significant
|
|
|
|
December 31,
|
|
|
in active
|
|
|
observable
|
|
|
unobservable
|
|
|
|
2008
|
|
|
markets
|
|
|
inputs
|
|
|
inputs
|
|
Short-term investments
|
|
$
|
16,400
|
|
|
$
|
16,400
|
|
|
$
|
|
|
|
$
|
|
|
Long-term investments
|
|
|
8,876
|
|
|
|
|
|
|
|
|
|
|
|
8,876
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
25,276
|
|
|
$
|
16,400
|
|
|
$
|
|
|
|
$
|
8,876
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments include available-for-sale securities and are measured at
fair value using quoted market prices and are classified within Level 1 of the valuation
hierarchy. Long-term investments consisting of ARS holdings have been valued using level
3 inputs. The Companys investments in auction rate securities are classified within
Level 3 because there are no active markets for the auction rate securities and therefore
the Company is unable to obtain independent valuations from market sources. Therefore,
the auction rate securities were valued using a discounted cash flow model. Some of the
inputs to the cash flow model are unobservable in the market. The adoption of SFAS 157
did not have any impact on the Companys results of operations or financial position.
4. Warrant Liability
The fair value of warrants issued by the Company in connection with an April 2007
sale of common stock has been recorded as a liability on the consolidated balance sheet
based on a Black-Scholes option pricing model, and is marked to market on each financial
reporting date. The change in fair value of the warrants is recorded in the consolidated
statements of operations as a non-cash gain or loss. As of December 31 and June 30, 2008,
the fair value of warrants was not material to the financial statements of the Company.
8
5. Stock-based Compensation
The Company recognizes stock-based compensation expense in its consolidated
statement of operations based on estimates of the fair value of employee stock option and
stock grant awards as measured on the grant date and uses the Black-Scholes option
pricing model to determine the value of the awards granted. The Company amortizes the
estimated value of the options over their vesting period, which generally ranges from one
to four years. The option pricing model requires various input assumptions, which are
noted in the tables below.
|
|
|
|
|
|
|
|
|
|
|
4 year vesting
|
|
|
1 year vesting
|
|
For the three and six months ended December 31, 2008:
|
|
10 year term
|
|
|
10 year term
|
|
Weighted average volatility
|
|
|
0.67
|
|
|
|
0.80
|
|
Expected dividends
|
|
|
|
|
|
|
|
|
Expected term (in years)
|
|
|
6.25
|
|
|
|
5.50
|
|
Risk free interest rate
|
|
|
2.8
|
%
|
|
|
2.60
|
%
|
|
|
|
|
|
|
|
|
|
|
|
4 year vesting
|
|
|
1 year vesting
|
|
For the three and six months ended December 31, 2007:
|
|
7 year term
|
|
|
10 year term
|
|
Weighted average volatility
|
|
|
0.80
|
|
|
|
0.83
|
|
Expected dividends
|
|
|
|
|
|
|
|
|
Expected term (in years)
|
|
|
4.75
|
|
|
|
5.50
|
|
Risk free interest rate
|
|
|
4.21
|
%
|
|
|
3.40
|
%
|
Expected volatilities are based on historical volatilities of the Companys stock.
The expected term of options represents the period that the Companys stock-based awards
are expected to be outstanding based on the simplified method, which is the mid-point
between the weighted-average vesting period and the contractual life of the option. The
Company has used the simplified method for estimating the terms of options granted
between July 1, 2008 and December 31, 2008 because management believes the magnitude of
the November 2007 underwritten public offering qualifies as a recapitalization of the
Company, which is a significant structural change rendering historical option exercise
data potentially unreasonable for estimating the expected term of options granted
subsequently. Nevertheless, an expected-term analysis based on historical stock option
grants for the Companys outstanding stock options at December 31, 2008 approximates the
expected term under the simplified method. The risk free interest rate for periods
related to the expected life of the options is based on the U.S. Treasury yield curve in
effect at the time of grant. The expected dividend yield assumed for all options granted
is zero, as the Company does not anticipate paying dividends in the near future.
Stock-based compensation expense has been recorded in the condensed consolidated
statement of operations as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended December 31,
|
|
|
Six months ended December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
General and administrative
|
|
$
|
133
|
|
|
$
|
159
|
|
|
$
|
272
|
|
|
$
|
317
|
|
Research and development
|
|
|
97
|
|
|
|
58
|
|
|
|
202
|
|
|
|
141
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense
|
|
$
|
230
|
|
|
$
|
217
|
|
|
$
|
474
|
|
|
$
|
458
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the three- and six- month periods ended December 31, 2008, the Company
granted options to purchase a total of 90,000 and 201,000 shares of common stock,
respectively, for which the aggregate grant-date fair value was $40,000 and $117,000,
respectively. During the three- and six- month periods ended December 31, 2007, the
Company granted options to purchase a total of 11,000 and 12,000 shares of common stock,
respectively, for which the aggregate grant-date fair value was $19,000 and $27,000,
respectively. As of December 31, 2008, there was $1,531,000 of total unrecognized
compensation cost related to unvested stock-based compensation awards which is expected
to be recognized over the weighted average vesting period of 3.5 years.
6. Net Loss per Share
Basic and diluted net loss per share is based on the weighted average number of
shares of common stock issued and outstanding during the period. If the Company had
reported net income, the dilutive effect of additional equity instruments totaling
2,678,000 and 1,012,000 shares for the three and six months ended December 31, 2008 and
2007, would need to be considered.
7. Comprehensive Loss
The Companys comprehensive loss was $9,157,000 and $12,450,000 for the three- and
six- month periods ended December 31, 2008, respectively, and $6,882,000 and $7,801,000
for the same periods in the prior year. The comprehensive loss is comprised of the net
loss and certain changes in equity that are excluded from the Companys net loss, which
are the unrealized holding gains or loss on available-for-sale investments.
9
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations.
Except for the historical information contained herein, the matters discussed in
this Managements Discussion and Analysis of Financial Condition and Results of
Operations, and elsewhere in this Form 10-Q are forward-looking statements that involve
risks and uncertainties. The factors referred to in the section captioned Risk Factors,
as well as any cautionary language in this Form 10-Q, provide examples of risks,
uncertainties and events that may cause our actual results to differ materially from
those projected. The Companys Annual Report on Form 10-K also contains risk factors that
provide examples of risks, uncertainties, and events that may cause our actual results to
differ materially from those implied or projected. For example, there can be no assurance
that:
|
|
|
We will be successful in restructuring our operations, preserving cash and
monetizing our existing assets;
|
|
|
|
|
costs to conclude the Viprinex clinical trials, meet our contractual
obligations to Nordmark for the snake farm and other expenses related to the
suspended development will fall within our estimates;
|
|
|
|
|
XERECEPT will be successfully developed or sold by Celtic Pharma;
|
|
|
|
|
we will be able to comply with Nasdaqs continued listing standards; or
|
|
|
|
|
we will receive sufficient liquidity for our auction-rate securities.
|
We disclaim any intent to update any forward-looking statement to reflect events
after the date of this report.
Overview
We are a biopharmaceutical company historically focused on developing novel,
first-in-class treatments for central nervous system conditions and other serious unmet
medical needs. We recently terminated development of our most advanced product candidate,
Viprinex (ancrod), which was studied in phase 3 clinical trials for evaluation as a new
drug to treat acute ischemic stroke. We have rights to receive royalty payments from the
sales of Namenda
®
(memantine), an approved drug marketed for Alzheimers disease, and
potential milestone and royalty payments from the development of XERECEPT
®
, an
investigational drug which is in phase 3 clinical trials for the treatment of swelling
associated with cerebral tumors. Our earlier stage pipeline also includes rights to a
protein in preclinical development for the treatment of Alzheimers disease.
Below is an overview of key developments affecting our business to date in fiscal
2009.
Viprinex, formerly a phase 3 investigational drug for stroke
In December 2008, we announced that an independent Data Safety Monitoring Board, or
DSMB, had determined that the phase 3 clinical trials of Viprinex for the treatment of
acute ischemic stroke were unlikely to show benefit. As a result, we immediately
terminated further enrollment in the trials. After further analysis of the data, we
subsequently determined that further development of Viprinex for the treatment of acute
ischemic stroke was not warranted, since no patient groups appeared to benefit from
treatment. We are in the process of fulfilling regulatory and contractual obligations for
the Viprinex program and we do not expect to undertake any further development of this
compound.
XERECEPT
®
, a Phase 3 investigational drug for which we have rights to receive milestone
and royalty/profit-sharing payments
Celtic Pharmaceuticals, or Celtic, to whom we sold rights to XERECEPT in 2005,
continues to develop XERECEPT (corticorelin acetate) for the treatment of brain edema
associated with cerebral tumors. Celtic has announced that it expects to present results
from its clinical program at two cancer conferences which will be held in the second
quarter of calendar 2009. Celtic has also announced that it has retained an investment
bank to assist with the sale of XERECEPT. While we are entitled to receive between 13%
and 22% of the net proceeds received by Celtic upon the sale of XERECEPT, we cannot
estimate if Celtic will be successful in their sale and whether we will receive any
payments under the agreement.
10
Preclinical Programs licensed from the Buck Institute for Age Research
In fiscal 2008, we entered into agreements with the Buck Institute for Age Research,
or Buck, for rights to proteins in early preclinical development for the treatment of
Alzheimers and Huntingtons diseases. In January 2009, we sent Buck a letter stating
that we did not intend to extend the research program term for the Huntingtons disease
program beyond the first year of the collaboration. As a result, we have ceased making
research funding payments to Buck for this program and we expect that Buck will
terminate the agreement and we will to lose our rights to that program. The initial year
of the Alzheimers research program will conclude in February 2009, and we are currently
evaluating Bucks research plan for the second year of the collaboration.
Employees
Following the discontinuance of our Viprinex program we terminated the employment of
over 50 percent of our employees. Termination of additional employees is planned as we
complete our regulatory and contractual obligations, and we expect that, by March 31,
2009, there will be approximately 7 employees remaining at the Company. We expect that
some of these employees will continue to support the clinical development of XERECEPT and
that the related costs will continue to be paid by Celtic.
The initial terminations occurred early in January 2009, and employment termination
charges of approximately $0.5 million will be included within our research and
development and general and administrative expenses for the third quarter of 2009.
The employment of Paul E. Freiman, our President and Chief Executive Officer from
May 1997 through December 2008, was terminated by our Board of Directors effective
December 31, 2008. On January 30, 2009, the Board appointed William A. Fletcher as Acting
Chief Executive Officer.
RESULTS OF OPERATIONS
Revenues
The major components of our revenue are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Variance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
From
|
|
|
|
|
|
|
|
|
|
|
Variance
|
|
|
|
|
|
|
|
|
|
|
|
Period in
|
|
|
|
|
|
|
|
|
|
|
From Period
|
|
|
|
Three months Ended
|
|
|
Prior
|
|
|
Six Months Ended
|
|
|
in Prior
|
|
|
|
December 31,
|
|
|
Year
|
|
|
December 31,
|
|
|
Year
|
|
|
|
2008
|
|
|
2007
|
|
|
2008/2007
|
|
|
2008
|
|
|
2007
|
|
|
2008/2007
|
|
Royalty Revenue
|
|
$
|
2,007
|
|
|
$
|
2,103
|
|
|
$
|
(96
|
)
|
|
$
|
4,085
|
|
|
$
|
4,084
|
|
|
$
|
1
|
|
XERECEPT Sale
|
|
|
1,375
|
|
|
|
1,375
|
|
|
|
|
|
|
|
2,750
|
|
|
|
2,750
|
|
|
|
|
|
Collaboration Services
|
|
|
109
|
|
|
|
185
|
|
|
|
(76
|
)
|
|
|
221
|
|
|
|
729
|
|
|
|
(508
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
3,491
|
|
|
$
|
3,663
|
|
|
$
|
(172
|
)
|
|
$
|
7,056
|
|
|
$
|
7,563
|
|
|
$
|
(507
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues of $3,491,000 for the three months ended December 31, 2008 decreased
by $172,000 from revenues of $3,663,000 in the same period of fiscal 2008. Our second
quarter fiscal 2009 revenues consisted of $2,007,000 from royalties on the commercial
sales of memantine by Merz and its marketing partners in the United States, $1,375,000
from the sale of our rights and interests in XERECEPT to Celtic and $109,000 from the
reimbursement of the direct expenses incurred for services provided to Celtic for
development of XERECEPT. Royalties were lower for the three months ended December 31,
2008 than the three months ended December 31, 2007 because of the elimination of
royalties on sales in Europe following the amendment of our agreement with Merz in
February 2008. Revenues from the sale of XERECEPT were the same for the three months
ended December 31, 2008 and for the three months ended December 31, 2007 because we are
recognizing the up-front payment of $33 million we received in November 2005 on a
straight-line basis over the estimated term of our obligations, which extends to
November 2011. Revenues from collaboration services declined by $76,000, or 41%, to
$109,000 for the three months ended December 31, 2008 compared to the three months ended
December 31, 2007 because we have transitioned most of the XERECEPT drug development work
to Celtic.
11
Revenues of $7,056,000 for the six months ended December 31, 2008 decreased $507,000
from revenues of $7,563,000 in the same period of fiscal 2008. Reasons for the changes
in the six-month period were the same as for the three-month period ended December 31,
2008, with lower reimbursements of our costs for development of XERECEPT accounting for
the decrease after the transition of most of the development work to Celtic.
RESEARCH AND DEVELOPMENT EXPENSES
Because we have historically engaged in the business of drug development and our
current drug candidates have not been approved for sale, the majority of our costs have
been related to the research and development of these drug candidates and the costs are
expensed as incurred. Research and development costs include clinical trial costs, drug
supply and manufacturing costs, salaries and related personnel costs for employees
involved in the development of our products, and other costs related to developing
investigational drugs, including outside consultants. The following table shows our
research and development expenses by product under development (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Variance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
From
|
|
|
|
|
|
|
|
|
|
|
Variance
|
|
|
|
|
|
|
|
|
|
|
|
Period in
|
|
|
|
|
|
|
|
|
|
|
From Period
|
|
|
|
Three months Ended
|
|
|
Prior
|
|
|
Six Months Ended
|
|
|
in Prior
|
|
|
|
December 31,
|
|
|
Year
|
|
|
December 31,
|
|
|
Year
|
|
|
|
2008
|
|
|
2007
|
|
|
2008/2007
|
|
|
2008
|
|
|
2007
|
|
|
2008/2007
|
|
Viprinex
|
|
$
|
9,925
|
|
|
$
|
6,893
|
|
|
$
|
3,032
|
|
|
$
|
14,834
|
|
|
$
|
11,794
|
|
|
$
|
3,040
|
|
XERECEPT
|
|
|
130
|
|
|
|
204
|
|
|
|
(74
|
)
|
|
|
206
|
|
|
|
764
|
|
|
|
(558
|
)
|
Preclinical programs
(Alzheimers and
Huntingtons
diseases)
|
|
|
337
|
|
|
|
319
|
|
|
|
18
|
|
|
|
804
|
|
|
|
319
|
|
|
|
485
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
10,392
|
|
|
$
|
7,416
|
|
|
$
|
2,976
|
|
|
$
|
15,844
|
|
|
$
|
12,877
|
|
|
$
|
2,967
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12
Total research and development expenses were $10,392,000 for the three months ended
December 31, 2008, which represented an increase of $2,976,000 compared to the three months
ended December 31, 2007. For the six months ended December 31, 2008, research and development
expenses were $15,844,000, an increase of $2,967,000 from the six months ended December 31,
2007.
For the periods covered by this Quarterly Report on Form 10-Q, the majority of our
research and development efforts and expenses were focused on Viprinex, to which we
acquired rights in July 2004 and which was a phase 3 investigational drug for the
treatment of acute ischemic stroke. Subsequent to acquiring these rights we established
good manufacturing practices, or GMP, manufacturing capability and initiated a large
phase 3 program designed to determine whether Viprinex was a safe and effective
treatment for stroke when given within six hours of onset. On December 16, 2008, our
independent DSMB met to review the efficacy of Viprinex for the first time since we
initiated our clinical trials. The DSMB determined that it was futile for us to continue
the clinical trials, as there was little difference between Viprinex and placebo in the
90 day measure of stroke-related disability which was the primary endpoint of the
clinical trial. As a result of the DSMB recommendation, we halted enrollment in the
clinical trial and we have instructed our vendors to terminate all activity associated
with the development of Viprinex.
For the three months ended December 31, 2008, our expenses related to Viprinex
aggregated $9,925,000, an increase of $3,032,000, or 44%, from expenses of $6,893,000
for the three months ended December 31, 2007. Increases in expenses for the three months
ended December 31, 2008 were primarily due to higher drug manufacturing costs as
follows:
|
|
|
A charge of approximately $3.7 million related to our estimated
obligations upon the termination of our contract with Nordmark, the operator
of the facility used to house the Malayan pit viper snakes whose venom was
used as a starting material for the active ingredient in Viprinex.
|
|
|
|
A charge of approximately $0.4 million for our estimated obligations to
Nordmark for the operation of the snake facility as long as the snakes are
expected to remain at the facility. Under the contractual terms, we own the
snakes and are obligated to pay the maintenance costs of the snakes.
|
|
|
|
Other manufacturing-related costs incurred as we prepared additional drug
material prior to the interim analysis.
|
The increased drug manufacturing costs recorded in research and development were
offset by decreases of approximately $1.2 million related to lower clinical trial
expenses following initiatives implemented to increase enrollment into the clinical
trials in the period ended December 31, 2007. Salary and benefit costs were also lower
in the period ended December 31, 2008, as we no longer provided for incentive bonuses to
be paid following the failure of the Viprinex clinical trial.
For the six months ended December 31, 2008, our spending on Viprinex aggregated
$14,834,000, an increase of $3,040,000, or 26%, compared to $11,794,000 for the six
months ended December 31, 2007. For both the three and six months ended December 31,
2008, the increase in costs for the development of Viprinex was approximately $3.0
million, and reasons for the increase in the six month period were the same as for the
three month period noted above.
For the three and six months ended December 31, 2008, our spending on XERECEPT
decreased to $130,000 and $206,000, respectively, from $204,000 and $764,000 for the
comparable periods in fiscal 2008. During the first two quarters of fiscal 2008 we
transitioned substantially all drug development activities to Celtic and are no longer
incurring these costs. The decrease in our research and development costs for XERECEPT is
comparable to the decrease in revenue for reimbursement of these costs by Celtic.
We entered into collaboration and license agreements with Buck for the development
of proteins in preclinical development for the treatment of Huntingtons and Alzheimers
diseases, in November 2007 and February 2008, respectively. Under the agreements, we fund
specified preclinical research work as performed by Buck in return for the development
rights to the proteins that are the subject of their research. For the three months ended
December 31, 2008, we incurred expenses only for the Alzheimers program, following our
determination not to renew the program for Huntingtons disease. Expenses for the three
months ended December 31, 2007 were related to the Huntingtons program. For the six
months ended December 31, 2008 we incurred greater total development expenses because two
programs were in place compared to only one program for the six months ended December 31,
2007.
For the third quarter of our fiscal year ending June 30, 2009, we expect research
and development costs to decrease significantly from the levels in the second quarter of
our 2009 fiscal year. Other than any additional costs that we may need to incur related
to the snakes held at Nordmark, we expect total Viprinex costs to aggregate to less than
$1 million. Thereafter we do not expect any costs related to the Viprinex program.
13
GENERAL AND ADMINISTRATIVE EXPENSES
The following table shows our general and administrative expenses (in thousands):
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase From
|
|
|
|
|
|
|
|
|
|
|
Increase From
|
|
Three months Ended
|
|
|
Period
|
|
|
Six Months Ended
|
|
|
Period
|
|
December 31,
|
|
|
in Prior Year
|
|
|
December 31,
|
|
|
in Prior Year
|
|
2008
|
|
|
2007
|
|
|
2008/2007
|
|
|
2008
|
|
|
2007
|
|
|
2008/2007
|
|
$
|
1,201
|
|
|
$
|
1,912
|
|
|
$
|
(711
|
)
|
|
$
|
2,532
|
|
|
$
|
3,571
|
|
|
$
|
(1,039
|
)
|
General and administrative expenses were $1,201,000 for the three months ended
December 31, 2008, a 37% decrease from expenses of $1,912,000 for the three months ended
December 31, 2007. The decrease of $711,000 for the three months ended December 31, 2008
was primarily due to cost savings measures implemented in the fourth quarter of fiscal
2008, which included a reduction in use of various consulting services. In addition, for
the three months ended December 31, 2008, we significantly reduced the provision for
employee bonuses following the failure of the Viprinex clinical trial program. Legal
expenses were also lower in the 2008 period, as were costs for compliance with sections
of the Sarbanes-Oxley Act.
General and administrative expenses were $2,532,000 for the six months ended
December 31, 2008, a 29% decrease from expenses of $3,571,000 for the six months ended
December 31, 2007. The reasons for the decrease of $1,039,000 in the six-month period
were generally the same as for the three-month period ended December 31, 2008.
We expect general and administrative expenses for future periods to be less than
they were for the three months ended December 31, 2008 due to termination of employees
and curtailment of a substantial portion of the Companys operations. The decrease in
general and administrative expenses is expected to be lower in the third quarter of
fiscal 2009 than in the fourth quarter of fiscal 2009 due to severance costs that will be
recorded in the third quarter of 2009.
INTEREST INCOME
Interest income for the three and six month periods ended December 31, 2008 was
$264,000 and $513,000, respectively, compared to $452,000 and $479,000, respectively, for
the same periods in the prior fiscal year. The decrease for the three month period of
fiscal 2009 compared to the same period in fiscal 2008 was due to a reduction in the
average cash and investments balances held and a decrease in the average interest rates
earned. The increase for the six months ended December 31, 2008 compared to the six
months ended December 31, 2007 was due to the Company having a higher average cash and
investments balance, partially offset by lower interest rates earned on the cash and
investments balances.
INTEREST EXPENSE
Interest expense for the three and six months ended December 31, 2007 was related to
short-term notes issued in September 2007 and repaid in November 2007. There was no
comparable expense for the three and six months ended December 31, 2008.
NON-CASH GAIN ON DECREASE IN FAIR VALUE OF WARRANTS
In April 2007, we issued warrants to purchase 435,000 shares of common stock in
connection with a concurrent sale of common stock. The warrants are exercisable through
April 2012 at a price of $16.80 per share. Although the terms of the warrants do not
provide for net-cash settlement, in certain circumstances, physical or net-share
settlement of the warrants is deemed not to be within our control and, accordingly, we
are required to account for these warrants as a derivative financial instrument
liability. The warrant liability is re-valued on each reporting date with changes in the
fair value from prior periods reported as non-cash charges or credits to earnings. For
warrant-based derivative financial instruments, the Black-Scholes option valuation model
is used to value the warrant liability. The classification of derivative instruments,
including whether these instruments should be recorded as liabilities or as equity, is
re-assessed at the end of each reporting period. The non-cash gain on the decrease in
fair value of warrants in the condensed consolidated statement of operations represents
changes in the Black-Scholes value of the warrants we issued, which has occurred
primarily as a result of the decrease in the price of our common stock. Because the
dollar-value decreases in our stock price were greater in the reporting periods that
ended on December 31, 2007, the non-cash gains were greater than during the reporting
periods that ended on December 31, 2008. Because the value of our stock has declined so
significantly since the warrants were issued, the value at which they are carried on our
balance sheet is now immaterial.
14
LIQUIDITY AND CAPITAL RESOURCES
We assess liquidity primarily by the cash and investments available to fund our
operations, which have been significantly curtailed since the Viprinex program for acute
ischemic stroke was terminated in December 2008. Our expenses for the next two quarters
are expected to be focused on the following areas:
|
|
|
Completion of our regulatory contractual obligations associated with the
terminated Viprinex program, including close-down of the clinical trial and
filing required reports in the United States and various foreign countries;
|
|
|
|
Close-down of the manufacturing facility that was built to house the
Malayan pit viper snakes, whose venom was used as the starting material for
the active ingredient in Viprinex, the removal of the approximately 1,000
snakes residing in the facility, and disposition of drug inventory at various
locations;
|
|
|
|
Continuation of our obligations to provide services to Celtic in connection
with the clinical development of XERECEPT;
|
|
|
|
Continuation of the preclinical research program for Alzheimers disease in
collaboration with the Buck Institute for Age Research; and
|
|
|
|
Administrative expenses associated with the above activities, negotiating
other contractual obligations and sustaining operations as a public company.
|
In addition to cash and investments, we also assess liquidity by our working capital
(modified to exclude deferred revenue and the warrant liability) available to fund
operations. We exclude deferred revenue and the warrant liability from our working
capital as we do not believe these items will ever require cash payments from us. The
following table shows our cash and short-term investments and working capital (in
thousands).
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and short-term investments
|
|
$
|
23,314
|
|
|
$
|
29,980
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, short-term and long-term investments
|
|
|
32,190
|
|
|
|
41,830
|
|
|
|
|
|
|
|
|
|
|
Working capital (excluding deferred revenue and the warrant liability)
|
|
|
15,262
|
|
|
|
27,357
|
|
Since our inception in 1987, we have applied the majority of our resources to our
research and development programs and have generated only limited operating revenue. We
have experienced operating losses in nearly every year since inception as we have funded
the development and clinical testing of our drug candidates. We expect to continue to
incur losses at least through the quarter ending March 31, 2009 and for the fiscal year
ending June 30, 2009
As of December 31, 2008, our combined balance of cash, cash equivalents and
short-term investments decreased by $6.7 million from the balance at the end of our most
recent fiscal year, June 30, 2008. The decrease was a result of the operating activities
of conducting our clinical trials and other operations of the Company, which used
approximately $8.0 million in cash. For the quarter ending on March 31, 2009, we expect
use of cash to be greater than our operating loss as we settle liabilities related to the
accrual of costs associated with the termination of the Viprinex program.
We believe that our cash and investments (long and short-term combined) as of
December 31, 2008 will be sufficient to fund our planned operations through at least the
next twelve months.
15
Our future capital requirements and net resources will depend on a number of
factors, including:
|
|
|
the time and cost involved in closing the recently terminated Viprinex trial and all other
activities related to the Viprinex program;
|
|
|
|
|
the value we are able to receive upon our disposition of the ARS we hold as long-term investments;
|
|
|
|
|
the royalties received from Merz on future sales of memantine;
|
|
|
|
|
the cost of our research collaboration with the Buck Institute for Age Research;
|
|
|
|
|
the receipt of milestone, royalty and profit-sharing payments pursuant to our agreements with
Celtic; and
|
|
|
|
|
the strategic alternatives that we choose to pursue.
|
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements that have or are reasonably likely to have
a current or future effect on our consolidated financial condition, changes in our
consolidated financial condition, revenues or expenses, consolidated results of
operations, liquidity, capital expenditures or capital resources.
Contractual Obligations
Our noncancelable contractual obligations are not materially changed from the table of
contractual obligations included in our Annual Report on Form 10-K. An update of the status of
key contractual obligations due in less than a year is included below.
Active ingredient production/purification and operation of a snake farm.
Raw venom
of the Malayan pit viper was the starting material for the active ingredient in Viprinex, and
was produced by Nordmark in Germany where Nordmark maintained a colony of snakes in a
manufacturing facility. We agreed to make monthly payments to Nordmark for our supply of the
active ingredient and for the fully burdened costs of operating the snake farm until such time
as either 1) the agreement is terminated pursuant to specified terms or 2) commercial production
commences. If the agreement is terminated by us prior to commercialization, we are required to
make a termination payment of up to 2.8 million (or approximately $3.7 million at the
December 31, 2008 exchange rate) to Nordmark. We have notified Nordmark of our intent to
terminate the agreement and remove the snakes located at the facility. Under the terms of the
agreement, we are responsible for specified operating costs of the facility as long as the
snakes are at the facility. We have identified several reptile zoos willing to take snakes, and
are in process of completing the arrangements for the transfer of the snakes. We cannot estimate
the costs for this process, but we currently expect it to be completed by March 31, 2009.
Clinical Research Organizations.
We had agreements in place with several Clinical
Research Organizations for work needed on the clinical trials in various foreign countries. We
generally paid the CROs on a monthly or quarterly basis for work as it was performed, and the
terms of most of the agreements allow them to be cancelled with no obligations beyond the costs
incurred by the CROs to the time of termination. Our CROs have closed down the clinical trial
and are in the process of reconciling pass-through costs for the clinical trial and amounts we
have paid compared to actual costs incurred. We have accrued expenses as of December 31, 2008
which we believe are appropriate under the agreements, and are holding further payments to the
CROs until we are satisfied that all costs are justified under the agreements. We expect
resolution with all CROs in the third or fourth quarter of our fiscal year ending June 30, 2009.
Medical facilities conducting the clinical trials.
We generally pay medical
facilities for each patient enrolled into our trials, and withhold a portion of total site
compensation until all data required in the clinical trial protocol is received. The portion
withheld is recorded as a liability in our consolidated financial statements. As we receive the
final data from each site we authorize the release of the final payments called for under the
agreements. We expect this process to be completed by March 31, 2009.
Data management.
We pay outside service organizations on a monthly or quarterly
basis for services related to managing the data collected from the clinical trial. We have
recorded an accrued liability for the charges we expect to incur, and the service organizations
are in process of reconciling the payments from NTI to the actual charges incurred. We expect
this process to be completed by June 30, 2009.
16
License agreement for Viprinex.
We have an exclusive worldwide license for all
human therapeutic indications for Viprinex from Abbott. Under this license, we have an
obligation to use commercially reasonable efforts to develop Viprinex for the treatment of acute
ischemic stroke. If we do not use commercially reasonable efforts to develop Viprinex for stroke
Abbott may reclaim rights to develop the product. While no license maintenance payments are
required to Abbott, milestone payments of up to $2 million would be due upon various regulatory
approvals of Viprinex, along with royalty payments based on worldwide Viprinex sales. In the
event we sublicense the rights to Viprinex, additional payments may be due to Abbott based on
the terms of the sublicense. We have the right to terminate the agreement upon providing 90 days
notice to Abbott, and Abbott has the right to terminate the agreement only in the event of our
breach. We presently do not intend to develop Viprinex further under the license from Abbott and
expect rights will ultimately be returned under the terms of the agreement. Upon returning the
rights to Abbott, we are also required to return all drug material, data and intellectual
property to Abbott.
Employees.
All of our employees are employed on an at-will basis.
Buck Institute for Age Research.
We have entered into agreements with Buck for
rights to preclinical proteins for the treatment of Alzheimers disease and Huntingtons
disease. The research programs under these agreements may be extended annually and we have the
right to terminate the agreements upon 60 days notice if we determine the research program
objectives cannot be substantially met. In addition, we have certain milestone obligations to
Buck in the event that specified research goals are met. We have notified Buck that we do not
intend to extend the research program for Huntingtons disease, and are currently reviewing the
Buck proposal for the second year of the Alzheimers disease research program.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
In the normal course of business, our financial position is subject to a variety of
risks, including market risk associated with interest rate movements. We regularly assess
these risks and have established policies and business practices designed to help us
protect against these and other exposures. We do not anticipate material potential losses
in these areas, but no policies or business practices can protect against all risks, and
there is always a chance that unanticipated risks could arise and create losses for us.
We invest funds not needed for near-term operating expenses in diversified
short-term and long-term investments, consisting primarily of investment grade
securities. We do not believe that changes in interest rates would result in a material
decrease or increase in the fair value of our available-for-sale securities due to the
general short-term nature of our investment portfolio, or the regular resetting of
interest rates on the securities we own which have an overall maturity date of more than
one year. We have no investments denominated in foreign country currencies and therefore
our investments are not subject to foreign currency exchange risk.
As of December 31, 2008, we had $8.9 million invested in ARS, issued principally by
student loan agencies and generally rated AAA by a major credit rating agency. Our
original purchase price for these securities was approximately $11.9 million, which was
subsequently written-down to a value of approximately $10.3 million in fiscal 2008 (for
the securities still held at December 31, 2008). ARS are structured to provide liquidity
via an auction process that resets the applicable interest rate at predetermined calendar
intervals, which are approximately once a month. Beginning in February 2008, auctions for
the securities in our portfolio began to fail, and none have been successful since that
time. We have classified all of our ARS as long-term investments as of December 31,
2008 and have estimated the fair value of these investments based on a model of
discounted future cash flows and assumptions regarding interest rates. If the auctions
for these securities continue to fail, the ARS may not be readily convertible into cash,
and we may be required to take losses on the sale of the securities. Based on our
expected cash usage for the next twelve months, we do not anticipate the current
illiquidity of these investments will affect our ability to operate our business as usual
for this period.
17
We have two offices in the United States, one of which we are in the process of closing,
and no offices in foreign locations. The manufacturer of the Active Pharmaceutical Ingredient,
or API, in our former investigational drug, Viprinex, is based in Germany and our close-down
obligations to this manufacturer are denominated in Euros. In addition, we have entered into
agreements with various service providers throughout the world, and as a result have payment
obligations denominated in various foreign currencies, although these have declined since the
termination of our Viprinex clinical trial. Because we do not maintain any accounts in foreign
currencies, decreases in the value of the United States dollar will increase our U.S. dollar
costs as additional U.S. dollars would be necessary to pay the same costs denominated in the
various foreign currencies.
Item 4. Controls and Procedures.
Our Acting Chief Executive Officer and our Chief Financial Officer are responsible
for establishing and maintaining disclosure controls and procedures (as defined in the
rules promulgated under the Securities Exchange Act of 1934, as amended) for our company.
Based on their evaluation of our disclosure controls and procedures (as defined in the
rules promulgated under the Securities Exchange Act of 1934), our Acting Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and procedures
were effective as of December 31, 2008, the end of the period covered by this report.
Changes in Internal Control over Financial Reporting.
There were no changes in our internal control over financial reporting during the
quarter ended December 31, 2008 that have materially affected, or are reasonably likely
to materially affect, our internal control over financial reporting.
PART II OTHER INFORMATION
Item 1. Legal Proceedings.
We are not currently party to any material legal proceedings, although from time to
time we may be named as a party to lawsuits in the normal course of business.
Item 1A. Risk Factors.
In addition to the other information set forth in this report, you should carefully
consider the factors discussed in Part I, Item 1A. Risk Factors in our Annual Report on
Form 10-K for the year ended June 30, 2008, filed with the SEC on September 16, 2008, and
the following updates to these risk factors. Any of these risks could materially affect
our business, financial condition and future results. The risks described below and in
our Annual Report on Form 10-K are not the only risks we face. Additional risks and
uncertainties not currently known to us or that we currently deem to be immaterial also
may materially adversely affect our business, financial condition and future results.
Our primary development asset, Viprinex for the treatment of acute ischemic stroke, did
not pass an interim futility analysis and certain costs for closing this program have not
been estimated or quantified
.
In December 2008, we announced that the clinical trials of Viprinex did not pass an
interim futility analysis and we stopped enrolling patients into the trials. In January
2009, after review of the data obtained from the clinical trial, we announced that we had
decided not to develop Viprinex further for the treatment of acute ischemic stroke. In
connection with this decision, we have terminated numerous agreements related to Viprinex
and announced staff reductions aggregating approximately 75% of our workforce by March
31, 2009. We are in the process of negotiating with the various vendors involved in the
Viprinex program following our termination of the contracts, and have made estimates in
the financial statements of the liabilities associated with the work performed and/or the
termination of the agreements. Our final settlement of the liabilities may be greater
than the amounts which we have estimated. In addition, we are not able to quantify the
costs related to the removal of the snakes from Nordmarks facility, and any charges we
incur for their removal will be recorded when incurred or when we are able to quantify
the costs.
18
If we do not continue retain key employees, our continuing operations and assets will be
impaired.
We depend on a small number of key management and scientific and technical
personnel. To meet our contractual obligations to Celtic Pharma, we are still dependent
on the technical skills of a selected number of employees working on the XERECEPT
program. We are also dependent on the knowledge of a selected number of general and
administrative employees as we complete Viprinex-related contracts and negotiate our
remaining contractual commitments. Given our clinical setback and the uncertainty of our
long-term prospects, our employees may be motivated to seek other positions and their
departure would impede our ability to fulfill our obligations and maximize the value of
out assets. While we have put a retention plan into place for selected employees, we
cannot be certain that this plan will be sufficient to motivate these key employees to
stay with the company until we determine our strategic alternatives.
We have a history of losses, we expect to generate losses in the near future, and we may
never achieve or maintain profitability.
As we have funded the development and clinical testing of our drug candidates, we
have experienced operating losses in nearly every year since our inception. As of
June 30, 2008, our accumulated deficit was approximately $136 million. With the loss of
our Viprinex program, there is no longer significant commercial potential for what was
our most promising prospect to achieve long-term profitability. We may never generate
sufficient revenues to become or remain profitable.
The current volatility and disruption in the capital and credit markets may continue to
exert downward pressure on our stock price and we may cease to be in compliance with the
continued listing standards set forth by the Nasdaq Capital Market. If we cease to be in
compliance with the continued listing standards, the Nasdaq Capital Market may commence
delisting proceedings against us.
The capital and credit markets have been experiencing extreme volatility and
disruption for more than twelve months. In recent months, the volatility and disruption
have reached unprecedented levels. Stock markets in general, and our stock price in
particular, have experienced significant price and volume volatility. Our stock is
trading near historic lows and we could continue to experience further declines in stock
price. Our stock is currently trading below $1.00 per share, which is in violation of
Nasdaqs standard continued listing requirements. Although Nasdaq has suspended the
enforcement of rules requiring a minimum $1.00 closing bid price, this suspension is
currently only in effect through April 20, 2009. There is no guarantee that we will be in
compliance with Nasdaqs continued listing requirements when this suspension is lifted.
If our stock continues to trade below $1.00 when the temporary suspension is lifted,
Nasdaq may commence delisting procedures against us. In addition, the Nasdaq Capital
Market requires listed companies such as NTI to maintain, among other things, a minimum
of $2.5 million in shareholders equity, as reported on the balance sheet on a quarterly
basis. Our shareholders equity was $8.3 million as of December 31, 2008, and we expect
our shareholders equity to decline for the next reporting period. If we do not maintain
compliance with this listing standard, Nasdaq may commence delisting procedures against
us. If we were to be delisted, the market liquidity of our common stock would likely be
adversely affected and the market price of our common stock would likely decrease. Such a
delisting could also adversely affect our ability to obtain financing for any
continuation of our operations and could result in a loss of confidence by investors,
suppliers and employees. In addition, our stockholders ability to trade or obtain
quotations on our shares could be severely limited because of lower trading volumes and
transaction delays. These factors could contribute to lower prices and larger spreads in
the bid and ask price for our common stock.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
19
Item 4. Submission of Matters to a Vote of Security Holders.
During the quarter ended December 31, 2008, the Company held its Annual Meeting of
Stockholders. The following matters were voted on at the meeting, which was held on November 13,
2008.
(1) The following three Class III directors were elected:
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Votes For
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Withheld
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Abraham D. Cohen
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20,029,714
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397,749
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Paul E. Freiman
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20,127,810
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299,653
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F. Van Kasper
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20,111,559
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315,904
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(2) The motion to ratify the selection of Odenberg, Ullakko, Muranishi & Co. LLP as
our independent registered public accounting firm for the fiscal year ending June 30,
2009 was approved; For 20,206,899; Against 199,812; Abstain 20,752.
Item 5. Other Information.
None.
Item 6. Exhibits
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31.1
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Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
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31.2
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Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
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32.1
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Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
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32.2
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Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
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20
SIGNATURES
Pursuant to the requirements of the Securities and 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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NEUROBIOLOGICAL TECHNOLOGIES, INC.
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Dated: February 12, 2009
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/s/
William A. Fletcher
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William A. Fletcher
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Acting Chief Executive Officer
(Principal Executive Officer)
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Dated: February 12, 2009
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/s/
Matthew M. Loar
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Matthew M. Loar
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Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)
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21
EXHIBIT INDEX
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Exhibit
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No.
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Description
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31.1
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Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
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31.2
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Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
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32.1
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Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
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32.2
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Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
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22
Neurobiological (NASDAQ:NTII)
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Neurobiological (NASDAQ:NTII)
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から 1 2024 まで 1 2025