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 March 31, 2009
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
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94-3049219
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(State or other jurisdiction of incorporation)
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(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 has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be submitted and
posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant was required to
submit and post such files).
Yes
o
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, $0.001 par value: 26,926,949 shares outstanding as of April 30, 2009.
NEUROBIOLOGICAL TECHNOLOGIES, INC.
FORM 10-Q
TABLE OF CONTENTS
2
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
NEUROBIOLOGICAL TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except per share amounts)
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March 31,
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June 30,
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2009
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2008
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(Unaudited)
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(Note 1)
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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6,009
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$
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27,941
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Short-term investments
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15,592
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2,039
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Accounts receivable
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229
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599
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Prepaid expenses and other current assets
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94
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280
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Total current assets
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21,924
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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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7,202
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11,850
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Property and equipment, net
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106
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393
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$
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29,317
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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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385
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$
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588
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Accrued clinical trial expenses
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1,628
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1,075
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Accrued manufacturing and related expenses
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3,359
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581
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Accrued external research expenses, professional expenses and other liabilities
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997
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1,258
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Warrant liability
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233
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40
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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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12,102
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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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9,167
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13,292
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Total liabilities
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21,269
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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, $0.001 par value, 50,000 shares authorized, 26,927 and 26,924
shares issued and outstanding at March 31, 2009 and June 30, 2008,
respectively
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27
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27
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Additional paid-in capital
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145,708
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145,113
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Accumulated deficit
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(136,622
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)
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(125,591
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)
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Accumulated other comprehensive (loss) income
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(1,312
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)
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490
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Total stockholders equity
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8,048
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20,286
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$
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29,317
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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
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Nine months ended
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March 31,
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March 31,
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2009
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2008
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2009
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2008
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REVENUES
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Royalty
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$
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1,505
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$
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2,161
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$
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5,590
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$
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6,245
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Technology sale and collaboration services
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1,508
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1,523
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4,479
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5,002
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Total revenues
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3,013
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3,684
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10,069
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11,247
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EXPENSES
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Research and development
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1,857
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5,945
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17,701
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18,822
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General and administrative
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1,438
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1,757
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3,970
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5,327
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Total expenses
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3,295
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7,702
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21,671
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24,149
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Operating loss
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(282
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)
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(4,018
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)
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(11,602
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)
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(12,902
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Interest income
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136
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540
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649
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1,020
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Realized gain on sale of long-term investments
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170
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Impairment charge for decrease in value of investments
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(55
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)
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(1,778
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)
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(55
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)
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(1,778
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)
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Interest expense, including non-cash amortization of discount
on notes of $2,336 for the nine months ended March 31, 2008,
respectively
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(2,479
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Non-cash (loss) gain on change in fair value of warrants
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(230
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193
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(193
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3,271
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NET LOSS
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$
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(431
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)
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$
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(5,063
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)
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$
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(11,031
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)
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$
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(12,868
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)
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BASIC AND DILUTED NET LOSS PER SHARE
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$
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(0.02
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)
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$
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(0.19
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)
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$
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(0.41
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)
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$
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(0.76
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)
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Shares used in basic and diluted net loss per share calculation
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26,927
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26,913
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26,925
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16,963
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See accompanying notes.
4
NEUROBIOLOGICAL TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited in thousands)
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Nine months ended
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March 31,
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2009
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2008
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OPERATING ACTIVITIES:
|
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Net loss
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$
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(11,031
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)
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$
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(12,868
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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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112
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154
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Loss on impairment of investments
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55
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1,778
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Loss on impairment of property and equipment
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174
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Stock-based compensation
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594
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647
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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 change in fair value of warrants
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193
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(3,271
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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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370
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(118
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)
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Prepaid expenses and other current assets
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186
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616
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Restricted cash and deposits
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(205
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)
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Accounts payable and accrued liabilities
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2,300
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(737
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)
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Deferred revenue
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(4,125
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)
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(4,125
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)
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Net cash used in operating activities
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(11,342
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)
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(15,793
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)
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INVESTING ACTIVITIES:
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Purchase of investments
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(33,280
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)
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(22,928
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)
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Maturity and sale of investments
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22,688
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7,802
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Sale (purchase) of property and equipment
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1
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(9
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)
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Net cash used in by investing activities
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(10,591
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)
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(15,135
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)
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FINANCING ACTIVITIES:
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Proceeds from purchases under the employee stock purchase plan
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1
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31
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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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|
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54,917
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(Decrease) increase in cash and cash equivalents
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(21,932
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)
|
|
|
23,989
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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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|
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Cash and equivalents at end of period
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$
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6,009
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$
|
29,527
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See accompanying notes.
5
NEUROBIOLOGICAL TECHNOLOGIES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2009
(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, Inc. (NTI or the Company) is a company
historically focused on developing investigational drugs for central nervous system
conditions and other serious unmet medical needs. NTI has the right to receive royalty
payments from the sales of Namenda (memantine HCL), an approved drug marketed for
Alzheimers disease. The Company also has the right to receive 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. NTI recently terminated the development of its most advanced product
candidate, Viprinex, which was studied in Phase 3 clinical trials as a potential new
drug to treat acute ischemic stroke. NTI has also recently chosen not to extend its
early-stage research collaborations for Alzheimers and Huntingtons diseases.
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 nine-month periods ended March 31, 2009 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 March 31,
|
|
|
As of June 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
Estimated
|
|
|
|
|
|
|
Estimated
|
|
|
|
Cost
|
|
|
Fair Value
|
|
|
Cost
|
|
|
Fair Value
|
|
Type of security and term
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate securities (ARS)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maturing in 22 to 37 years
|
|
$
|
10,197
|
*
|
|
$
|
8,882
|
|
|
$
|
11,372
|
*
|
|
$
|
11,850
|
|
Corporate debt obligations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maturing within one year
|
|
|
13,909
|
|
|
|
13,912
|
|
|
|
2,027
|
|
|
|
2,039
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total investments
|
|
$
|
24,106
|
|
|
$
|
22,794
|
|
|
$
|
13,399
|
|
|
$
|
13,889
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Classification
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term
|
|
|
|
|
|
$
|
15,592
|
|
|
|
|
|
|
$
|
2,039
|
|
Long-term
|
|
|
|
|
|
|
7,202
|
|
|
|
|
|
|
|
11,850
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total investments
|
|
|
|
|
|
$
|
22,794
|
|
|
|
|
|
|
$
|
13,889
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Cost represents purchase price less impairment charge of $1,653,000 and
$1,768,000 on securities held at March 31, 2009 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 $1,315,000 on its
ARS at March 31, 2009 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. An
impairment charge of $55,000 was recorded during the three months ended March 31, 2009,
based on a price actually received by the Company from the sale of $2.0 million in par
value of ARS subsequent to March 31, 2009 (proceeds were $1,680,000). All other
unrealized gains and losses were immaterial. The Company has classified its ARS as
long-term at March 31, 2009, except for the security sold subsequently, which, together
with all other investments, is classified as short-term. The following table shows
additional information regarding the individual ARS held by the Company and classified
as long-term investments:
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2009
|
|
|
|
Par
|
|
|
Estimated
|
|
|
|
Value
|
|
|
Fair Value
|
|
ARS
|
|
|
|
|
|
|
|
|
Vermont Student Assistant Loan Corporation
|
|
$
|
2,000
|
|
|
$
|
1,429
|
|
Pennsylvania St. Higher Ed. Assistance Agency
|
|
|
2,000
|
|
|
|
1,349
|
|
Panhandle Plains Student Fin. Corporation
|
|
|
1,400
|
|
|
|
1,108
|
|
Brazos Texas Higher Ed. Authority
|
|
|
1,200
|
|
|
|
871
|
|
Kentucky Higher Ed. Student Loan Corporation
|
|
|
1,000
|
|
|
|
791
|
|
Others, none individually over $600 in estimated fair value
|
|
|
2,250
|
|
|
|
1,654
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
9,850
|
|
|
$
|
7,202
|
|
|
|
|
|
|
|
|
7
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.
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. The adoption of SFAS 157 did not have any impact on the Companys results of
operations or financial position. 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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
Carrying
|
|
|
|
|
|
|
Value as of
|
|
|
Fair Value Measurements at March 31, 2009
|
|
|
|
March 31,
|
|
|
Using Inputs from
|
|
|
|
2009
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
Short-term investments
|
|
$
|
15,592
|
|
|
$
|
13,912
|
|
|
$
|
1,680
|
|
|
$
|
|
|
Long-term investments
|
|
|
7,202
|
|
|
|
|
|
|
|
|
|
|
|
7,202
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
22,794
|
|
|
$
|
13,912
|
|
|
$
|
1,680
|
|
|
$
|
7,202
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, or Level 2
if they represent ARS with reliable observable inputs. Long-term investments consisting of ARS
holdings have been valued using level 3 inputs. The Companys investments in ARS are generally
classified within Level 3 because there are no active markets for the ARS and the Company is unable
to obtain independent valuations
from market sources. Therefore, the ARS were valued using a discounted cash flow model. Some
of the inputs to the cash flow model are unobservable in the market. The changes in Level 3 assets
measured at fair value for the nine months ended March 31, 2009 were as follows:
|
|
|
|
|
|
|
Changes in Fair Value
|
|
|
|
Measurements of
|
|
Activity for the nine months ended
|
|
Securities Valued with
|
|
March 31, 2009 (unaudited)
|
|
Level 3 Inputs
|
|
Balance at June 30, 2008
|
|
$
|
11,850
|
|
Unrealized losses included in other comprehensive loss
|
|
|
(1,805
|
)
|
Sales of securities
|
|
|
(1,108
|
)
|
Impairment charge recognized in net loss
|
|
|
(55
|
)
|
Transfers out of Level 3 securities
|
|
|
(1,680
|
)
|
|
|
|
|
Balance at March 31, 2009
|
|
$
|
7,202
|
|
|
|
|
|
8
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 fair value on each
financial reporting date. The change in fair value of the warrants is recorded in the
consolidated statement of operations as a non-cash gain or loss. The key assumptions
used to value the warrants at March 31, 2009 were a volatility factor of 2.13, a
risk-free interest rate of 1.2% and no dividend yield for the remaining 3 years until
maturity.
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 nine months ended March 31, 2009:
|
|
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
|
%
|
|
|
2.6
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immediate
|
|
|
|
4 year vesting
|
|
|
vesting
|
|
For the three and nine months ended March 31, 2008:
|
|
7 year term
|
|
|
3 year term
|
|
Weighted average volatility
|
|
|
0.76 0.83
|
|
|
|
0.83
|
|
Expected dividends
|
|
|
|
|
|
|
|
|
Expected term (in years)
|
|
|
4.75 5.50
|
|
|
|
3.0
|
|
Risk free interest rate
|
|
|
2.6 4.2
|
%
|
|
|
2.8
|
%
|
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 approximated the expected term under the simplified method.
No stock options were granted during the period from December 31, 2008 to March 31,
2009. 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
|
|
|
Nine months ended
|
|
|
|
March 31,
|
|
|
March 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
General and administrative
|
|
$
|
70
|
|
|
$
|
119
|
|
|
$
|
342
|
|
|
$
|
436
|
|
Research and development
|
|
|
50
|
|
|
|
70
|
|
|
|
252
|
|
|
|
211
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense
|
|
$
|
120
|
|
|
$
|
189
|
|
|
$
|
594
|
|
|
$
|
647
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9
During the three-month period ended March 31, 2009, the Company did not grant any
stock options. During the nine-month period ended March 31, 2009, the Company granted
options to purchase a total of 201,000 shares of common stock for which the aggregate
grant-date fair value was $117,000. During the three- and nine-month periods ended
March 31, 2008, the Company granted options to purchase a total of 15,000 and 27,000
shares of common stock, respectively, for which the aggregate grant-date fair value was
$22,000 and $49,000, respectively. As of March 31, 2009, there was $270,000 of total
unrecognized compensation cost related to unvested stock-based compensation awards which
is expected to be recognized over the remaining weighted average vesting period of 3.25
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 1,002,000 shares for the periods ended March 31, 2009 and 2008,
respectively, would need to be considered.
7. Comprehensive Loss
The Companys comprehensive loss was $383,000 and $12,833,000 for the three- and
nine-month periods ended March 31, 2009, respectively, and $5,049,000 and $12,850,000
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.
8. Recently Issued Accounting Standards
The following pronouncements have been recently issued but have not been adopted by
the Company:
In April 2009, the Financial Accounting Standards Board (FASB) issued FSP FAS
115-2 and FAS 124-2,
Recognition and Presentation of Other-Than-Temporary Impairments
.
This FSP amends the other-than-temporary impairment guidance for debt securities to
change the presentation and disclosure of other-than-temporary impairments on debt and
equity securities in the financial statements. This FSP does not amend existing
recognition and measurement guidance related to other-than-temporary impairments of
equity securities. This FSP modifies the requirements for recognizing
other-than-temporarily impaired debt securities and revises the existing impairment
model for such securities, by modifying the current intent and ability indicator in
determining whether a debt security is other-than-temporarily impaired. The FSP is
effective for reporting periods ending after June 15, 2009. The Company does not expect
the adoption of this FSP to have a material effect on its consolidated financial
statements.
In April 2009, the FASB issued FSP FAS 157-4,
Determining Fair Value When the
Volume and Level of Activity for the Asset or Liability Have Significantly Decreased and
Identifying Transactions That Are Not Orderly
. This FSP provides additional guidance for
estimating fair value in accordance with SFAS No. 157,
Fair Value Measurements
, when the
volume and level of activity for the asset or liability have significantly decreased.
This FSP also includes
guidance on identifying circumstances that indicate when a transaction is not
orderly. FSP 157-4 provides guidance on how to determine the fair value of assets and
liabilities under SFAS 157 in the current economic environment and reemphasizes that the
objective of a fair value measurement remains an exit price. This FSP is effective for
reporting periods ending after June 15, 2009. The Company is currently evaluating the
impact of this FSP on its consolidated financial statements.
10
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 our efforts to enhance shareholder value, either through a potential
sale of the Company or other means;
|
|
|
|
|
we will be able to preserve cash and monetize our existing assets;
|
|
|
|
|
costs to conclude the remaining portions of the Viprinex program 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 ARS.
|
Overview
We are a company historically focused on developing investigational drugs for
central nervous system conditions and other serious unmet medical needs. We have the
right to receive royalty payments from the sales of Namenda (memantine HCL), an approved
drug marketed for Alzheimers disease. We also have the right to receive 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. We recently terminated the development of what was
previously our most advanced product candidate, Viprinex, which was studied in Phase 3
clinical trials as a potential new treatment for acute ischemic stroke. We have also
recently chosen not to extend our early-stage research collaborations for Alzheimers
and Huntingtons diseases.
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 was not warranted, since no
patient groups appeared to benefit from treatment. We have sent a letter to Abbott
Laboratories, terminating the license under which we obtained the rights to develop and
commercialize Viprinex, and we have terminated the employment of all employees that were
working on the Viprinex program. We are in the process of fulfilling remaining
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 an upcoming cancer conference 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
whether Celtic will be successful in their attempts to sell XERECEPT or whether we will
receive any payments under the agreement.
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 the third quarter of fiscal 2009,
we sent Buck letters stating that we did not intend to extend the research program terms
for either the
Huntingtons or Alzheimers disease program beyond the first year of the respective
collaborations. As a result, we have ceased making research funding payments to Buck and
expect to lose our rights to develop the proteins that formed the basis for the
collaborations.
11
Employees
Following the discontinuance of our Viprinex program, we terminated the employment
of over 75 percent of our employees, all during the third quarter of fiscal 2009. As of
March 31, 2009, there were a total of eight full- and part-time employees at the
Company. Four of these employees continue to support the clinical development of
XERECEPT, and their direct costs are reimbursed to us by Celtic.
Employment termination charges aggregating approximately $0.6 million were incurred
in the third quarter of fiscal 2009, comprising approximately $0.4 million included in
our research and development expenses and $0.2 million in general and administrative
expenses.
The employment of Paul E. Freiman, appointed President and Chief Executive Officer
in May 1997, 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.
Future of Neurobiological Technologies as a Company
In March 2009, we announced that we retained RBC Capital Markets, or RBC, as our
financial advisor to assist in the evaluation of various options to enhance shareholder
value, including a potential sale of the Company or our major assets. Our goal is to
determine whether there is a transaction that would be more beneficial to our
shareholders than a liquidation. In the event that our evaluation of strategic options
does not result in a transaction that meets our objectives, we intend to return as much
cash as possible to our shareholders through a liquidation or other means. Our board of
directors intends to act expeditiously in the process of seeking a strategic
transaction.
RESULTS OF OPERATIONS
Revenues
The major components of our revenue are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease in
|
|
|
|
|
|
|
|
|
|
|
Decrease in
|
|
|
|
Three months ended
|
|
|
2009
|
|
|
Nine months ended
|
|
|
2009
|
|
|
|
March 31,
|
|
|
Compared
|
|
|
March 31,
|
|
|
Compared
|
|
|
|
2009
|
|
|
2008
|
|
|
to 2008
|
|
|
2009
|
|
|
2008
|
|
|
to 2008
|
|
Royalty revenue
|
|
$
|
1,505
|
|
|
$
|
2,161
|
|
|
$
|
(656
|
)
|
|
$
|
5,590
|
|
|
$
|
6,245
|
|
|
$
|
(655
|
)
|
XERECEPT sale
|
|
|
1,375
|
|
|
|
1,375
|
|
|
|
|
|
|
|
4,125
|
|
|
|
4,125
|
|
|
|
|
|
Collaboration services
|
|
|
133
|
|
|
|
148
|
|
|
|
(15
|
)
|
|
|
354
|
|
|
|
877
|
|
|
|
(523
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
3,013
|
|
|
$
|
3,684
|
|
|
$
|
(671
|
)
|
|
$
|
10,069
|
|
|
$
|
11,247
|
|
|
$
|
(1,178
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues of $3,013,000 for the three months ended March 31, 2009 decreased by
$671,000 from revenues of $3,684,000 in the same period of fiscal 2008. Our third
quarter fiscal 2009 revenues consisted of $1,505,000 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 $133,000 from the
reimbursement of the direct expenses incurred for services provided to Celtic for
development of XERECEPT. Royalties on sales of memantine were lower in the three months
ended March 31, 2009 than the three months ended March 31, 2008 because of a scheduled
reduction in the royalty rate we are entitled to receive from Merz and from 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 March 31, 2009 and for the three months ended March 31, 2008 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 obligation to provide services to Celtic, which
extends to November 2011. Revenues from collaboration services declined by $15,000, or
10%, to $133,000 for the three months ended March 31, 2009 compared to the three months
ended March 31, 2008 due to normal fluctuations in the work charged to Celtic for
XERECEPT development.
12
Changes for the nine-month period ended March 31, 2009 compared to the nine-month
period ended March 31, 2008 were the same as for the three-month periods, except the
decrease in revenues from collaboration services declined by a greater percentage in
2009 as compared to fiscal 2008. The larger decrease for the collaboration services
revenue for the nine months ended March 31, 2009 occurred due the transition of most of
the XERECEPT drug development work to Celtic in fiscal 2008. Following this transition,
we ceased incurring these expenses and the respective reimbursements from Celtic.
RESEARCH AND DEVELOPMENT EXPENSES
Because we have historically engaged in the business of drug development and our
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):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease in
|
|
|
|
|
|
|
|
|
|
|
Decrease in
|
|
|
|
Three months ended
|
|
|
2009
|
|
|
Nine months ended
|
|
|
2009
|
|
|
|
March 31,
|
|
|
Compared
|
|
|
March 31,
|
|
|
Compared
|
|
|
|
2009
|
|
|
2008
|
|
|
to 2008
|
|
|
2009
|
|
|
2008
|
|
|
to 2008
|
|
Viprinex
|
|
$
|
1,651
|
|
|
$
|
5,122
|
|
|
$
|
(3,471
|
)
|
|
$
|
16,485
|
|
|
$
|
16,915
|
|
|
$
|
(430
|
)
|
XERECEPT
|
|
|
160
|
|
|
|
182
|
|
|
|
(22
|
)
|
|
|
366
|
|
|
|
947
|
|
|
|
(581
|
)
|
Preclinical programs
|
|
|
46
|
|
|
|
641
|
|
|
|
(595
|
)
|
|
|
850
|
|
|
|
960
|
|
|
|
(110
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
1,857
|
|
|
$
|
5,945
|
|
|
$
|
(4,088
|
)
|
|
$
|
17,701
|
|
|
$
|
18,822
|
|
|
$
|
(1,121
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total research and development expenses were $1,857,000 for the three months ended
March 31, 2009, which represented a decrease of $4,088,000 compared to the three months
ended March 31, 2008. For the nine months ended March 31, 2009, research and development
expenses were $17,701,000, a decrease of $1,121,000 from the nine months ended March 31,
2008.
For the three months ended March 31, 2009, our expenses related to Viprinex
aggregated $1,651,000, a decrease of $3,471,000, or 68%, from expenses of $5,122,000 for
the three months ended March 31, 2008. The decrease in expenses for the three months
ended March 31, 2009 was due to our decision to no longer develop Viprinex following the
results of the interim analysis. Included in the expenses for the three months ended
March 31, 2009 are costs to complete close-down of the clinical trial, costs for
close-down of the snake farm and purification facility we had established for the
production of active ingredient (which was derived from the venom of Malayan pit vipers)
and employee termination costs.
For the nine months ended March 31, 2009, our expenditures on Viprinex aggregated
$16,485,000, a decrease of $430,000, or 3%, compared to $16,915,000 for the nine months
ended March 31, 2008. The decrease in costs related to the development of Viprinex is
primarily due to lower clinical trial expenses in fiscal 2009 following the termination
of the development of Viprinex, which were mostly offset by nonrecurring costs
associated with the close-down of the snake facility and purification unit.
We do not expect significant costs for the Viprinex program in future periods.
For the three months ended March 31, 2009, our expenditures related to XERECEPT
decreased to $160,000 from $182,000 for the comparable period in fiscal 2008, due to
normal fluctuations in the level of activity. For the nine months ended March 31, 2009,
our expenditures related to XERECEPT declined by $581,000, or 61%, compared to the nine
months ended March 31, 2008. During the first nine months of fiscal 2008 we transitioned
substantially all drug development activities to Celtic, and accordingly in fiscal 2008
incurred a higher level of costs prior to the completion
of the transition. The decrease in our research and development costs for XERECEPT
is comparable to the decrease in revenue for reimbursement of these costs by Celtic.
13
During the third quarter of fiscal 2009, we sent termination letters related to our
preclinical research programs that had been conducted in collaboration with the Buck
Institute for Age Research, and therefore incurred lower costs for the preclinical
programs than we incurred in the third quarter of fiscal 2008. Expenses for the
preclinical programs also decreased for the nine month periods ended March 31, 2009, for
the same reason, although by a smaller percentage due to research conducted earlier in
fiscal 2009 before the termination letters were sent.
GENERAL AND ADMINISTRATIVE EXPENSES
The following table shows our general and administrative expenses (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease in
|
|
|
|
|
|
|
|
|
|
|
Decrease in
|
|
Three months ended
|
|
|
2009
|
|
|
Nine months ended
|
|
|
2009
|
|
March 31,
|
|
|
Compared
|
|
|
March 31,
|
|
|
Compared
|
|
2009
|
|
2008
|
|
|
to 2008
|
|
|
2009
|
|
|
2008
|
|
|
to 2008
|
|
$ 1,438
|
|
$
|
1,757
|
|
|
$
|
(319
|
)
|
|
$
|
3,970
|
|
|
$
|
5,327
|
|
|
$
|
(1,357
|
)
|
General and administrative expenses were $1,438,000 for the three months ended
March 31, 2009, a decrease of 18% from expenses of $1,757,000 for the three months ended
March 31, 2008. During the quarter ended March 31, 2009 we incurred lower costs for
employee salaries, investor relations and business development consultants. These lower
costs were partially offset by severance charges for terminated administrative employees
and close-down costs for our New Jersey office. For the year-to-date periods, general
and administrative expenses were lower due to the aforementioned reasons, as well as a
reduction in use of outside consultants, lower legal expenses and lower costs of
compliance with internal control certification requirements.
We expect general and administrative expenses for future periods to be less than
they were for the three months ended March 31, 2009 due to a lower number of employees
and a reduced need for administrative work in the absence of an active internal drug
development program. If we make no changes to our current operating structure, we
estimate that general and administrative expenses, excluding noncash charges, will be
less than $1.0 million for each quarter of operations. If we are successful in finding a
transaction that enhances shareholder value, we will likely incur additional one-time
charges associated with the transaction.
INTEREST INCOME
Interest
income for the three- and nine-month periods ended March 31, 2009 was
$136,000 and $649,000, respectively, compared to $540,000 and $1,020,000, respectively,
for the same periods in the prior fiscal year. The decreases for the three- and
nine-month periods of fiscal 2009 compared to the same periods in fiscal 2008 were due
to lower average cash and investments balances and a decrease in the average interest
rates earned.
IMPAIRMENT CHARGE FOR DECREASE IN VALUE OF INVESTMENTS
An
impairment charge of $55,000 was recorded for the three- and nine-month periods
ended March 31, 2009, as compared to an impairment charge of $1,778,000 for the
three- and nine-month periods ended March 31, 2008. The impairment charge recorded during
fiscal 2009 was related to ARS we sold after March 31, 2009, for which proceeds were
less than cost. The impairment charge recorded in fiscal 2008 was related to the initial
failure of ARS auctions and our estimated value of the ARS based on a model of
discounted cash flows and interest rates.
INTEREST EXPENSE
Interest expense for the nine months ended March 31, 2008 was related to short-term
notes issued in September 2007 and repaid in November 2007. There was no comparable
expense for the nine months ended March 31, 2009.
NON-CASH GAIN/LOSS 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 the estimated fair
value of these warrants as a 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. The Black-Scholes option valuation model is used to
estimate the value of the warrant liability. During the three months ending March 31,
2009, the estimated value of the warrants increased primarily due to the increased
volatility of our common stock, as well as an increase in value of our stock, causing us
to recognize a loss on the change in value of the warrants. Because the dollar-value of
our stock price decreased substantially during the reporting periods that ended on March
31, 2008, in the prior fiscal year the Company recognized a non-cash gain based on the
estimated value of the warrants.
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. Our expenses for the next quarter are expected to be
focused on the following areas:
|
|
|
Completion of our regulatory contractual obligations associated with
the terminated Viprinex program, including filing required reports in
the United States and various foreign countries;
|
|
|
|
Seeking to monetize our assets;
|
|
|
|
|
Continuation of our obligations to provide services to Celtic in
connection with the clinical development of XERECEPT; and
|
|
|
|
|
Administrative expenses associated with the above activities, the
process of evaluating options to enhance shareholder value,
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).
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
June 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and short-term investments
|
|
$
|
21,601
|
|
|
$
|
29,980
|
|
Cash, cash equivalents, short-term and long-term investments
|
|
|
28,803
|
|
|
|
41,830
|
|
Working capital (excluding deferred revenue and the warrant liability)
|
|
|
15,555
|
|
|
|
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 incur losses
for the fiscal year ending June 30, 2009. Although we may be profitable for the fourth
quarter of 2009 and for fiscal 2010, we do not expect our business to be able to sustain
long-term profitability.
As of March 31, 2009, our combined balance of cash, cash equivalents and short-term
investments decreased by $8.4 million from the balance at the end of our most recent
fiscal year, June 30, 2008. The decrease was primarily a result of the operating
activities of conducting and then closing down our clinical trials, development of
Viprinex, termination of drug manufacturing obligations and the other operations of the
Company, which used approximately $11.3 million in cash, which was partially offset by
proceeds received from the sale of long-term investments. For the quarter ended June 30,
2009, we expect our cash to decrease by a greater amount than our net loss as we settle
liabilities related to the development of Viprinex which were not paid to the vendors by
March 31, 2009 (such as the closure of the snake facility and purification unit). We
expect cash, cash equivalents, short-term and long-term investments to total
approximately $23 million at June 30, 2009, assuming we have fully paid off all
currently accrued Viprinex-related costs.
We believe that our cash and investments (long and short-term combined) as of March
31, 2009 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 final costs involved in completing remaining obligations 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;
|
|
|
|
|
any milestone, royalty and profit-sharing payments we receive 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 that extend beyond the next twelve months
are summarized in the following table (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments due by period
|
|
|
|
|
|
|
|
Current fiscal
|
|
|
|
|
|
|
Over 3
|
|
|
|
Total
|
|
|
year
|
|
|
1-3 years
|
|
|
years
|
|
Operating lease obligations
|
|
$
|
490
|
|
|
$
|
93
|
|
|
$
|
397
|
|
|
$
|
|
|
Others
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
490
|
|
|
$
|
93
|
|
|
$
|
397
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The only material change from the table of contractual obligations included in our
Annual Report on Form 10-K is the elimination of an estimated obligation for a
contingent payment to Nordmark that was required in the event we did not commercialize
Viprinex. On May 4, 2009, we reached agreement with Nordmark to terminate all
obligations under our earlier agreements with them in exchange for a one-time payment of
approximately
2.1 million (approximately $2.8 million) from us to Nordmark. The payment
to Nordmark has been accrued in the balance sheet as of March 31, 2009, and is not
additionally reflected in the above table. We do not expect to incur further costs
related to either the operation of the Nordmark snake farm or the removal of the snakes
from the facility. A further update of the status of key contractual obligations,
including those which are cancelable, due in less than a year is included below.
Clinical Research Organizations.
We had agreements in place with several Clinical
Research Organizations, or CROs, 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. As
of March 31, 2009, our CROs have closed down the clinical trial at most sites with which
they were involved. We are in the process of reconciling CRO-related costs for the
clinical trial and the amounts we have paid to each CRO to date compared to actual costs
incurred, as well as reviewing the validity of the costs incurred. We have accrued
expenses as of March 31, 2009 which we believe are appropriate under the agreements, and
are holding further payments to each CRO until we are satisfied that all costs are
justified under the agreements and we reach agreement with the CRO on final amounts. We
currently expect resolution with all CROs in the fourth quarter of our fiscal year
ending June 30, 2009.
Medical facilities conducting the clinical trials.
We have largely completed the
process of reconciling and paying costs incurred by the various medical facilities for
each patient enrolled into our trials, and expect any further payments or costs related
to the medical facilities not to be material in future periods.
Data management.
We have reached agreement with the outside service organizations
involved in managing the data collected from the clinical trial and expect any further
costs related to data management not to be material in future periods.
16
License agreement for Viprinex.
We were developing Viprinex under a worldwide
license from Abbott Laboratories. Under the license, we had an obligation to use
commercially reasonable efforts to develop Viprinex for the treatment of acute ischemic
stroke. Based on the results of our clinical trials, we do not plan to further develop
Viprinex for the treatment of stroke, or for any other indication, and we have notified
Abbott of our intention to terminate the Viprinex license agreement. As required by the
license, we are in the process of returning all drug material, data and intellectual
property to Abbott. We expect this to be completed following the completion of the final
study report, which is currently being reviewed by independent physicians.
Employees.
All of our employees are employed on an at-will basis. Although we
do not have a severance plan, we have notified our remaining employees that they would
be offered certain payments if they elect to sign a release of claims following the
termination of their employment by NTI. If all remaining employees were terminated, we
estimate aggregate payments in exchange for release of claims would be less than $0.5
million.
Buck Institute for Age Research.
In fiscal 2008 we entered into two agreements
with Buck for development and commercialization rights to preclinical proteins for the
treatment of Alzheimers disease and Huntingtons disease. Each agreement provided for
funding three successive one-year research program terms. We have notified Buck that we
did not intend to extend either program beyond the initial one-year research program
term, and accordingly, we do not expect to incur further costs related to either of the
Buck agreements.
RECENT ACCOUNTING PRONOUNCEMENTS
The following pronouncements have been recently issued but have not been adopted by
the Company:
In April 2009, the Financial Accounting Standards Board, or FASB, issued FSP FAS
115-2 and FAS 124-2,
Recognition and Presentation of Other-Than-Temporary Impairments
.
This FSP amends the other-than-temporary impairment guidance for debt securities to
change the presentation and disclosure of other-than-temporary impairments on debt and
equity securities in the financial statements. This FSP does not amend existing
recognition and measurement guidance related to other-than-temporary impairments of
equity securities. This FSP modifies the requirements for recognizing
other-than-temporarily impaired debt securities and revises the existing impairment
model for such securities, by modifying the current intent and ability indicator in
determining whether a debt security is other-than-temporarily impaired. The FSP is
effective for reporting periods ending after June 15, 2009. We do not expect the
adoption of this FSP to have a material effect on our consolidated financial statements.
In April 2009, the FASB issued FSP FAS 157-4,
Determining Fair Value When the
Volume and Level of Activity for the Asset or Liability Have Significantly Decreased and
Identifying Transactions That Are Not Orderly
. This FSP provides additional guidance for
estimating fair value in accordance with SFAS No. 157,
Fair Value Measurements
, when the
volume and level of activity for the asset or liability have significantly decreased.
This FSP also includes guidance on identifying circumstances that indicate when a
transaction is not orderly. FSP 157-4 provides guidance on how to determine the fair
value of assets and liabilities under SFAS 157 in the current economic environment and
reemphasizes that the objective of a fair value measurement remains an exit price. This
FSP is effective for reporting periods ending after June 15, 2009. We are currently
evaluating the impact of this FSP on our consolidated financial statements.
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.
17
As of March 31, 2009, we had $7.2 million invested in long-term 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 $9.9 million,
which was subsequently written-down to a value of approximately $8.5 million in fiscal
2008 (for the securities still held and classified as long-term at March 31, 2009).
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 unsold ARS as long-term investments as of March 31, 2009, 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.
We have one office, located in Emeryville, California. We closed-down our
Edgewater, New Jersey office in February 2009. We do not have any 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, which are currently not
hedged for fluctuations in exchange rates. 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 Euro.
Item 4T. 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 March 31, 2009, 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 March 31, 2009 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 company is in a transition phase, and so the future of our company is uncertain.
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 clinical trials we
were conducting. In January 2009, after review of the data obtained from the clinical
trials, we announced that we would not develop Viprinex further. In connection with this
decision, we implemented staff reductions aggregating approximately 75% of our earlier
workforce, and currently only have eight full and part-time employees. We have also
terminated two preclinical research programs under which we had development and
commercialization rights. As a result, the marketing and development of the remaining
products in which we have retained interests (memantine and XERECEPT) are controlled by
third parties. We have engaged RBC as our financial advisor to assist in the evaluation
of various options to enhance shareholder value, including a sale of the Company or our
major assets. Because the process is not completed, we are not able to predict the
ultimate outcome, and the value received by our shareholders in either process may be
less than anticipated by the shareholders. This process may not be successful, which
could result in a decline in our stock price.
18
Our primary development asset, Viprinex for the treatment of acute ischemic stroke, did
not pass an interim futility analysis and certain remaining costs for closing this
program are estimated.
Following the failure of our Viprinex program, we terminated the significant
contracts that we had entered into for development of the asset. We are in the process
of negotiating with various vendors involved in the Viprinex program 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, which would result
in costs being recorded in future periods and future cash balances lower than what we
are currently projecting.
If we do not continue to 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
our 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 March
31, 2009, our accumulated deficit was approximately $137 million. With the termination
of our Viprinex program, there is no longer significant commercial potential for what
was previously 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.
Stock markets in general, and our stock price in particular, have experienced
significant price and volume volatility over the past year. Our stock price deteriorated
significantly in fiscal 2008 and to date in fiscal 2009, and we could continue to
experience further declines in our 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 scheduled to end on July 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. 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 sell the Company
and enhance shareholder value. 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.
Item 4. Submission of Matters to a Vote of Security Holders.
None.
Item 5. Other Information.
None.
19
Item 6. Exhibits
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10.1
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Termination Agreement, dated as of May 4, 2009, by and between the
Company and Nordmark Arzneimittel GmbH & Co. KG
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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
|
|
32.2
|
|
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Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
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: May 8, 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: May 8, 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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|
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|
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Exhibit
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|
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No.
|
|
Description
|
|
10.1
|
|
|
Termination Agreement, dated as of May 4, 2009, by and between the
Company and Nordmark Arzneimittel GmbH & Co. KG
|
|
31.1
|
|
|
Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
31.2
|
|
|
Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
32.1
|
|
|
Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
32.2
|
|
|
Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
22
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