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x
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Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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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Delaware
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33-0960223
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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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
x
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(Do not check if a smaller
reporting company)
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Item No.
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Page No.
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Condensed Consolidated Balance Sheets -
September 30, 2014 and December 31, 2013
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Condensed Consolidated Statements of Operations and Comprehensive Loss - Three and Nine Months Ended September 30, 2014 and 2013
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Condensed Consolidated Statements of Cash Flows -
Nine Months Ended September 30, 2014 and 2013
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Item 1.
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Financial Statements
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September 30,
2014 |
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December 31,
2013 |
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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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20,395
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|
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$
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9,935
|
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Marketable securities
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15,889
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|
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60,110
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Prepaid and other current assets
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541
|
|
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3,382
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Restricted cash
|
15
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|
|
200
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Total current assets
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36,840
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73,627
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Property and equipment, net
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13
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43
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Total assets
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$
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36,853
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$
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73,670
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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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447
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$
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413
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Accrued liabilities
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2,192
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|
|
1,515
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Total current liabilities
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2,639
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|
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1,928
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Commitments and contingencies
|
|
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Stockholders’ equity:
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||||
Common stock
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19
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|
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19
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Additional paid-in capital
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188,078
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211,257
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Accumulated deficit
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(153,887
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)
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(139,556
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)
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Accumulated other comprehensive income
|
4
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|
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22
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Total stockholders’ equity
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34,214
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71,742
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Total liabilities and stockholders’ equity
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$
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36,853
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$
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73,670
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Three Months Ended
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Nine Months Ended
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||||||||||||
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September 30,
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September 30,
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||||||||||||
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2014
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2013
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2014
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2013
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||||||||
Revenue:
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Gross royalty revenue
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$
|
182
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$
|
418
|
|
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$
|
962
|
|
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$
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1,381
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Gross other revenue
|
—
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|
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50
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|
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—
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|
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50
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|
||||
Advertising expense - Purdue Pharma
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—
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(86
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)
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—
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(6,681
|
)
|
||||
Net revenue
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182
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|
|
382
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|
962
|
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(5,250
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)
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Operating expenses:
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|
|
|
|
|
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||||||||
Research and development
|
295
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|
|
2,410
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1,589
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|
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5,151
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|
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General and administrative
|
3,753
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|
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2,658
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|
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9,328
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|
|
8,490
|
|
||||
Notes receivable impairment
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4,300
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|
|
—
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4,300
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|
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—
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|
||||
Goodwill impairment
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—
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|
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—
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|
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—
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|
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2,962
|
|
||||
Total operating expenses
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8,348
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|
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5,068
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15,217
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16,603
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|
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Loss from operations
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(8,166
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)
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(4,686
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)
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(14,255
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)
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(21,853
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)
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Interest and other income (expense), net
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(35
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)
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(17
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)
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(76
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)
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(58
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)
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Net loss
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$
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(8,201
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)
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$
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(4,703
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)
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$
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(14,331
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)
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$
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(21,911
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)
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Net loss per share:
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Basic and diluted
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$
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(0.43
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)
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$
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(0.25
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)
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$
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(0.75
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)
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$
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(1.17
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)
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Cash distribution declared per common share
|
$
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—
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|
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$
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—
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$
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1.33
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|
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$
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—
|
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Weighted average common shares outstanding:
|
|
|
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||||||||
Basic and diluted
|
19,156
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|
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18,782
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18,995
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|
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18,748
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||||||||
Other comprehensive loss:
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||||||||
Changes in unrealized gain (loss) on marketable securities
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(4
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)
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40
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(18
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)
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24
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|
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Comprehensive loss
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$
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(8,205
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)
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$
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(4,663
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)
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$
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(14,349
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)
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$
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(21,887
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)
|
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Nine Months Ended September 30,
|
||||||
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2014
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|
2013
|
||||
Operating activities
|
|
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|
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Net loss
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$
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(14,331
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)
|
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$
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(21,911
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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
|
17
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82
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|
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Stock-based compensation
|
1,540
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2,339
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|
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Gain on disposals of fixed assets
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(102
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)
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(25
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)
|
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Amortization of premium on available for sale securities
|
428
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|
641
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|
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Impairment of goodwill
|
—
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2,962
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|
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Impairment of notes receivable
|
4,300
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|
|
—
|
|
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Changes in operating assets and liabilities:
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|
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|
||||
Prepaid and other current assets
|
2,841
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|
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6,158
|
|
||
Accounts payable
|
34
|
|
|
894
|
|
||
Accrued liabilities
|
677
|
|
|
(497
|
)
|
||
Net cash used in operating activities
|
(4,596
|
)
|
|
(9,357
|
)
|
||
Investing activities
|
|
|
|
||||
Purchases of property and equipment
|
—
|
|
|
(12
|
)
|
||
Proceeds from the sale of property and equipment
|
115
|
|
|
32
|
|
||
Issuance of notes receivable
|
(4,300
|
)
|
|
—
|
|
||
Purchases of marketable securities
|
(15
|
)
|
|
(63,813
|
)
|
||
Maturities of marketable securities
|
43,975
|
|
|
46,980
|
|
||
Net cash provided by (used in) investing activities
|
39,775
|
|
|
(16,813
|
)
|
||
Financing activities
|
|
|
|
||||
Cash distributions paid to common stockholders
|
(25,408
|
)
|
|
—
|
|
||
Proceeds from issuance of common stock, net
|
689
|
|
|
444
|
|
||
Net cash (used in) provided by financing activities
|
(24,719
|
)
|
|
444
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|
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Net increase (decrease) in cash and cash equivalents
|
10,460
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|
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(25,726
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)
|
||
Cash and cash equivalents at beginning of period
|
9,935
|
|
|
39,368
|
|
||
Cash and cash equivalents at end of period
|
$
|
20,395
|
|
|
$
|
13,642
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•
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the approximately
30%
decline in Intermezzo prescriptions at June 30, 2013 from the peak of the direct to consumer ("DTC") advertising campaign, which was substantially completed in April 2013; and
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•
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the May 2013 termination by Purdue of
90
contract sales representatives dedicated exclusively to promoting Intermezzo, resulting in reliance solely on Purdue's existing analgesics sales force of approximately
525
sales representatives.
|
•
|
Up-front license payments are assessed to determine whether or not the licensee is able to obtain any stand-alone value from the license. Where this is not the case, the Company does not consider the license deliverable to be a separate unit of accounting, and the revenue is deferred with revenue recognition for the license fee assessed in conjunction with the other deliverables that constitute the combined unit of accounting. When the period of
|
•
|
Payments received that are related to substantive, performance-based “at-risk” milestones are recognized as revenue upon achievement of the milestone or event specified in the underlying contracts, which represents the culmination of the earnings process. Amounts received in advance, if any, are recorded as deferred revenue until the milestone is reached; and
|
•
|
Royalty revenue from sales of the Company’s licensed product is recognized as earned in accordance with the contract terms when royalties from licensees can be estimated and collectability is reasonably assured.
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
September 30,
|
|
September 30,
|
||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
Numerator:
|
|
|
|
|
|
|
|
||||||||
Net loss
|
$
|
(8,201
|
)
|
|
$
|
(4,703
|
)
|
|
$
|
(14,331
|
)
|
|
$
|
(21,911
|
)
|
Denominator for basic and diluted net loss per share:
|
|
|
|
|
|
|
|
||||||||
Weighted average common shares outstanding
|
19,156
|
|
|
18,782
|
|
|
18,995
|
|
|
18,748
|
|
|
Nine Months Ended
|
||||
|
2014
|
|
2013
|
||
Excluded potentially dilutive securities (1):
|
|
|
|
||
Shares subject to options to purchase common stock
|
3,872
|
|
|
4,454
|
|
Shares subject to warrants to purchase common stock
|
61
|
|
|
61
|
|
Total
|
3,933
|
|
|
4,515
|
|
(1)
|
The number of shares is based on the maximum number of shares issuable on exercise or conversion of the related securities as of the period end. Such amounts have not been adjusted for the treasury stock method or weighted average outstanding calculations as required if the securities were dilutive.
|
|
September 30, 2014
|
||||||||||||||
|
Amortized
Cost
|
|
Unrealized
Gains
|
|
Unrealized
Losses
|
|
Estimated
Fair Value
|
||||||||
Money market funds
|
$
|
8,912
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
8,912
|
|
Commercial paper
|
11,063
|
|
|
—
|
|
|
—
|
|
|
11,063
|
|
||||
Government sponsored enterprise issues
|
12,741
|
|
|
2
|
|
|
—
|
|
|
12,743
|
|
||||
U.S. Treasury securities
|
3,143
|
|
|
2
|
|
|
—
|
|
|
3,145
|
|
||||
|
$
|
35,859
|
|
|
$
|
4
|
|
|
$
|
—
|
|
|
$
|
35,863
|
|
|
December 31, 2013
|
||||||||||||||
|
Amortized
Cost
|
|
Unrealized
Gains
|
|
Unrealized
Losses
|
|
Estimated
Fair Value
|
||||||||
Certificates of deposit
|
$
|
200
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
200
|
|
Money market funds
|
769
|
|
|
—
|
|
|
—
|
|
|
769
|
|
||||
Commercial paper
|
12,910
|
|
|
—
|
|
|
—
|
|
|
12,910
|
|
||||
Corporate notes
|
16,704
|
|
|
9
|
|
|
—
|
|
|
16,713
|
|
||||
Government sponsored enterprise issues
|
36,157
|
|
|
10
|
|
|
—
|
|
|
36,167
|
|
||||
U.S. Treasury securities
|
3,228
|
|
|
3
|
|
|
—
|
|
|
3,231
|
|
||||
|
$
|
69,968
|
|
|
$
|
22
|
|
|
$
|
—
|
|
|
$
|
69,990
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2014
|
|
2013
|
||||
Cash and cash equivalents
|
|
$
|
19,959
|
|
|
$
|
9,680
|
|
Marketable securities
|
|
15,889
|
|
|
60,110
|
|
||
Restricted cash
|
|
15
|
|
|
200
|
|
||
|
|
$
|
35,863
|
|
|
$
|
69,990
|
|
|
|
|
|
|
•
|
Level 1—Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs;
|
•
|
Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and
|
•
|
Level 3—Unobservable inputs (i.e. inputs that reflect the reporting entity’s own assumptions about the assumptions that market participants would use in estimating the fair value of an asset or liability) are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
|
|
|
|
Fair Value Measurements at Reporting Date Using
|
||||||||||||
|
September 30,
2014 |
Quoted
Prices in
Active
Markets for
Identical
Assets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
8,912
|
|
|
$
|
8,912
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Commercial paper
|
11,063
|
|
|
—
|
|
|
11,063
|
|
|
—
|
|
||||
Government sponsored enterprise issues
|
12,743
|
|
|
—
|
|
|
12,743
|
|
|
—
|
|
||||
U.S. Treasury securities
|
3,145
|
|
|
—
|
|
|
3,145
|
|
|
—
|
|
||||
|
$
|
35,863
|
|
|
$
|
8,912
|
|
|
$
|
26,951
|
|
|
$
|
—
|
|
|
|
|
Fair Value Measurements at Reporting Date Using
|
||||||||||||
|
December 31,
2013 |
|
Quoted
Prices in
Active
Markets for
Identical
Assets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Certificates of deposit
|
$
|
200
|
|
|
$
|
200
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Money market funds
|
769
|
|
|
769
|
|
|
—
|
|
|
—
|
|
||||
Commercial paper
|
12,910
|
|
|
—
|
|
|
12,910
|
|
|
—
|
|
||||
Corporate notes
|
16,713
|
|
|
—
|
|
|
16,713
|
|
|
—
|
|
||||
Government sponsored enterprise issues
|
36,167
|
|
|
—
|
|
|
36,167
|
|
|
—
|
|
||||
U.S. Treasury securities
|
3,231
|
|
|
—
|
|
|
3,231
|
|
|
—
|
|
||||
|
$
|
69,990
|
|
|
$
|
969
|
|
|
$
|
69,021
|
|
|
$
|
—
|
|
◦
|
Purdue Pharma paid a
$25.0 million
non-refundable license fee in August 2009;
|
◦
|
Purdue Pharma paid a
$10.0 million
non-refundable intellectual property milestone in December 2011 when the first of two issued formulation patents was listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book;
|
◦
|
Purdue Pharma paid a
$10.0 million
non-refundable intellectual property milestone in August 2012 when the first of two issued method of use patents was listed in the FDA's Orange Book;
|
◦
|
The Company transferred the Intermezzo
New Drug Application (NDA) to Purdue Pharma, and Purdue Pharma is obligated to assume the expense associated with maintaining the NDA and further development of Intermezzo in the United States, including any expense associated with post-approval studies;
|
◦
|
Purdue Pharma is obligated to commercialize Intermezzo in the United States at its expense using commercially reasonable efforts;
|
◦
|
Purdue Pharma is obligated to pay the Company tiered base royalties on net sales of Intermezzo in the United States ranging
from the mid-teens up to the mid-20%
level. The base royalty is tiered depending upon the achievement of certain fixed net sales thresholds by Purdue Pharma, which net sales levels reset each year for the purpose of calculating the royalty; and
|
◦
|
Purdue Pharma is obligated to pay the Company up to an additional
$70.0 million
upon the achievement of certain net sales targets for Intermezzo in the United States.
|
•
|
up to
$6.5 million
upon the occurrence of certain development milestones, including NDA approval of TO-2070 by the FDA,
|
•
|
up to
$35.0 million
in commercialization milestone payments tied to the achievement of specified annual sales levels of TO-2070, and
|
•
|
tiered, low double-digit royalties
on annual net sales of TO-2070.
|
•
|
Actavis & Watson: In the July 2012 notifications, Actavis and Watson indicated that each company's ANDA includes Paragraph IV patent certifications to our U.S. Patent Nos. 7,658,945 (expiring April 15, 2027) and 7,682,628 (expiring February 16, 2025) (together, the “'945 and '628 Patents”). On November 28, 2012, Watson withdrew its ANDA, and, as a result of such withdrawal, on December 18, 2012, the Company and Purdue agreed to voluntarily dismiss the action without prejudice and on December 20, 2012 a court order was entered to such effect. The dismissal of Watson's ANDA had no effect on the ANDA filed by Actavis, a wholly owned subsidiary of Watson Pharmaceuticals, Inc. On January 24, 2013, Actavis notified the Company that it has included Paragraph IV patent certifications to Transcept's U.S. Patent Nos. 8,242,131 (expiring August 20, 2029) and 8,252,809 (expiring February 16, 2025) (together, the “'131 and '809 Patents”).
|
•
|
Novel: In the July 2012 notifications, Novel indicated that its ANDA includes Paragraph IV patent certifications to the '945 and '628 Patents. On December 10, 2012, Novel notified the Company that it has included Paragraph IV patent certifications to the '131 and '809 Patents.
|
•
|
Par Entities: The ANDAs submitted by the Par Entities each include Paragraph IV patent certifications to the '945, '628, '131 and '809 Patents.
|
•
|
Dr. Reddy's: The ANDA submitted by Dr. Reddy's includes Paragraph IV patent certifications to the '945, '628, '131 and '809 Patents.
|
•
|
TWi: The ANDA submitted by TWi includes Paragraph IV patent certifications to the '945, '628, '131 and '809 Patents.
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
•
|
the timing and completion of our merger with Paratek, including any dividend in connection therewith;
|
•
|
our continued listing on NASDAQ after the merger with Paratek;
|
•
|
our expectations regarding the capitalization, resources and ownership structure of the combined organization after our merger with Paratek;
|
•
|
the timing and nature of the planned equity investment and bridge loan in connection with the merger with Paratek;
|
•
|
the possibility of a dissolution of the Company if we are not successful in completing the merger with Paratek;
|
•
|
possible future royalties on Intermezzo sales and potential proceeds from any sale of assets relating to Intermezzo;
|
•
|
the nature, strategy and focus of the combined organization after our merger with Paratek;
|
•
|
the development and commercial potential of any product candidates after our merger with Paratek, including Omadacycline;
|
•
|
the executive and board structure of the combined organization after our merger with Paratek;
|
•
|
expectations regarding voting by Transcept and Paratek stockholders in connection with the proposed merger;
|
•
|
expected activities and responsibilities of us and Purdue Pharmaceuticals L.P., or Purdue Pharma, under our United States License and Collaboration Agreement, or the Collaboration Agreement;
|
•
|
expectations for the commercial potential of Intermezzo and our collaboration partner's commitment to collaborate with us;
|
•
|
the future satisfaction of conditions required for continued commercialization of Intermezzo under the Collaboration Agreement, and the fulfillment of Purdue Pharma's obligations under the Collaboration Agreement;
|
•
|
our expectations regarding suits that Purdue Pharma or we have filed or may file in regards to Abbreviated New Drug Application, or ANDA, proceedings, and the timing, costs and results of such actions and ANDA proceedings;
|
•
|
our potential receipt of revenue under the Collaboration Agreement, including milestone and royalty revenue;
|
•
|
the receipt of payments, if any, from SNBL under the Termination Agreement and Release, dated September 19, 2014, by and between Transcept and SNBL, or SNBL Termination Agreement;
|
•
|
expectations regarding reimbursement for Intermezzo
in the United States;
|
•
|
expectations with respect to our ability to successfully and profitably carry out plans to co-promote Intermezzo to psychiatrists in the United States through our co-promotion option under the Collaboration Agreement;
|
•
|
the potential benefits of, and markets for, Intermezzo and TO-2070;
|
•
|
potential competitors and competitive products, including generic manufacturers;
|
•
|
expectations with respect to our intent and ability to successfully enter into other collaboration or co-promotion arrangements;
|
•
|
expectations regarding our ability to obtain regulatory approval of Intermezzo outside of the United States;
|
•
|
the adequacy of our current cash, cash equivalents and marketable securities to fund our operations for at least the next twelve months;
|
•
|
our beliefs regarding the merits of pending litigation and our expectations regarding our response to such litigation;
|
•
|
expectations regarding the value of our net operating loss carry forwards, or NOLs, and the preservation of such NOLs by our tax benefit preservation plan adopted in September 2013, or Tax Benefit Preservation Plan;
|
•
|
expectations regarding future losses, costs, expenses, expenditures and cash flows;
|
•
|
the ability and degree to which we may obtain and maintain market exclusivity from the U.S. Food and Drug Administration, or FDA, for Intermezzo under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, or FFDCA; and
|
•
|
our ability to maintain and obtain additional patent protection for Intermezzo without violating the intellectual property rights of others.
|
•
|
our inability to successfully complete the proposed merger with Paratek and subsequent difficulties we may face as a stand-alone company;
|
•
|
the inability of the combined organization after our merger with Paratek to successfully develop and commercialize products and/or product candidates, or to sell our Intermezzo asset;
|
•
|
potential termination of the Collaboration Agreement by Purdue Pharma
;
|
•
|
actual and potential decreases in Purdue Pharma's commercialization efforts with respect to Intermezzo;
|
•
|
physician or patient reluctance to use Intermezzo;
|
•
|
unexpected results from and/or additional costs related to ANDA proceedings;
|
•
|
changing standards of care and the introduction of products by competitors that could reduce our royalty rates under the Collaboration Agreement, or alternative therapies for the treatment of indications we target;
|
•
|
generic equivalents to Intermezzo whose introduction would reduce royalty rates under the Collaboration Agreement;
|
•
|
the receipt of payments, if any, from SNBL pursuant to the terms of the SNBL Termination Agreement;
|
•
|
our inability to obtain additional financing, if available, under favorable terms, if necessary;
|
•
|
the ability of our Tax Benefit Preservation Plan adopted in September 2013 to protect the value of our net operating loss carryforwards;
|
•
|
unexpected adverse side effects or inadequate therapeutic efficacy of our product candidates that could slow or prevent product approval or approval for particular indications;
|
•
|
the uncertainty of protection for our intellectual property, through patents, trade secrets or otherwise; and
|
•
|
potential infringement of the intellectual property rights or trade secrets of third parties.
|
◦
|
Purdue Pharma paid us a $25.0 million non-refundable license fee in August 2009;
|
◦
|
Purdue Pharma paid us a $10.0 million non-refundable intellectual property milestone in December 2011 when the first of two issued formulation patents was listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book;
|
◦
|
Purdue Pharma paid us a $10.0 million non-refundable intellectual property milestone in August 2012 when the first of two issued method-of-use patents was listed in the FDA's Orange Book;
|
◦
|
We transferred the Intermezzo
New Drug Application (“NDA”) to Purdue Pharma, and Purdue Pharma is obligated to assume the expense associated with maintaining the NDA and further development of Intermezzo in the United States, including any expense associated with post-approval studies;
|
◦
|
Purdue Pharma is obligated to commercialize Intermezzo in the United States at its expense using commercially reasonable efforts;
|
◦
|
Purdue Pharma is obligated to pay us tiered base royalties on net sales of Intermezzo in the United States ranging from the mid-teens up to the mid-20% level. The base royalty is tiered depending upon the achievement of certain fixed net sales thresholds by Purdue Pharma, which net sales levels reset each year for the purpose of calculating the royalty; and
|
◦
|
Purdue Pharma is obligated to pay us up to an additional $70.0 million upon the achievement of certain net sales targets for Intermezzo in the United States.
|
•
|
up to $6.5 million upon the occurrence of certain development milestones, including NDA approval of TO-2070 by the FDA,
|
•
|
up to $35.0 million in commercialization milestone payments tied to the achievement of specified annual sales levels of TO-2070, and
|
•
|
tiered, low double-digit royalties on annual net sales of TO-2070.
|
•
|
salaries, benefits, travel and related expense for personnel associated with research and development activities;
|
•
|
fees paid to professional service providers for services related to the conduct and analysis of pre-clinical and clinical trials;
|
•
|
contract manufacturing costs for formulations used in clinical trials and pre-commercial manufacturing and packaging costs;
|
•
|
fees paid to consultants to evaluate product in-licensing or acquisition opportunities, to advise us on the development of internally generated new product concepts, to development of TO-2070 and the wind down of TO-2061;
|
•
|
laboratory supplies and materials;
|
•
|
depreciation of equipment; and
|
•
|
allocated costs of facilities and infrastructure.
|
|
|
Three months ended September 30,
|
|||||||||||||
|
|
|
|
|
|
Favorable
|
|
%
|
|||||||
|
|
2014
|
|
2013
|
|
(Unfavorable)
|
|
Change
|
|||||||
Net revenue
|
|
$
|
182
|
|
|
$
|
382
|
|
|
$
|
(200
|
)
|
|
52
|
%
|
Research and development expense
|
|
295
|
|
|
2,410
|
|
|
2,115
|
|
|
88
|
%
|
|||
General and administrative expense
|
|
3,753
|
|
|
2,658
|
|
|
(1,095
|
)
|
|
41
|
%
|
|||
Notes receivable impairment
|
|
4,300
|
|
|
—
|
|
|
(4,300
|
)
|
|
—
|
%
|
|
|
Nine months ended September 30,
|
|||||||||||||
|
|
|
|
|
|
Favorable
|
|
%
|
|||||||
|
|
2014
|
|
2013
|
|
(Unfavorable)
|
|
Change
|
|||||||
Net revenue
|
|
$
|
962
|
|
|
$
|
(5,250
|
)
|
|
$
|
6,212
|
|
|
118
|
%
|
Research and development expense
|
|
1,589
|
|
|
5,151
|
|
|
3,562
|
|
|
69
|
%
|
|||
General and administrative expense
|
|
9,328
|
|
|
8,490
|
|
|
(838
|
)
|
|
10
|
%
|
|||
Notes receivable impairment
|
|
4,300
|
|
|
—
|
|
|
(4,300
|
)
|
|
—
|
%
|
|||
Goodwill impairment
|
|
—
|
|
|
2,962
|
|
|
2,962
|
|
|
100
|
%
|
•
|
the approximately 30% decline in Intermezzo prescriptions at June 30, 2013 from the peak of the direct to consumer ("DTC") advertising campaign, which was substantially completed in April 2013; and
|
•
|
the May 2013 termination by Purdue of 90 contract sales representatives dedicated exclusively to promoting Intermezzo, resulting in reliance solely on Purdue's existing analgesics sales force of approximately 525 sales representatives.
|
|
|
Nine months ended September 30,
|
||||||
|
|
2014
|
|
2013
|
||||
|
|
|
|
|
||||
Net cash used in operating activities
|
|
$
|
(4,596
|
)
|
|
$
|
(9,357
|
)
|
Net cash provided by (used in) investing activities
|
|
39,775
|
|
|
(16,813
|
)
|
||
Net cash (used in) provided by financing activities
|
|
(24,719
|
)
|
|
444
|
|
•
|
our ability to complete the merger with Paratek, including paying any related dividends;
|
•
|
the timing and nature of any strategic transactions that we undertake;
|
•
|
the level of Purdue Pharma's commercialization efforts with respect to Intermezzo;
|
•
|
the potential costs associated with Intermezzo if our existing Collaboration Agreement with Purdue is terminated, including the increased costs to us of litigation expense in connection with ANDA proceedings related to Intermezzo;
|
•
|
the receipt of milestone and other payments, if any, from Purdue Pharma under the Collaboration Agreement;
|
•
|
the receipt of payments, if any, from SNBL under the SNBL Termination Agreement;
|
•
|
the effect of competing technological and market developments; and
|
•
|
the cost incurred in responding to disruptive actions by activist stockholders.
|
Item 3.
|
Quantitative and Qualitative Disclosures About Market Risk
|
Item 4.
|
Controls and Procedures
|
Item 1.
|
Legal Proceedings
|
•
|
Actavis & Watson: In the July 2012 notifications, Actavis and Watson indicated that each company's ANDA includes Paragraph IV patent certifications to our U.S. Patent Nos. 7,658,945 (expiring April 15, 2027) and 7,682,628 (expiring February 16, 2025) (together, the “'945 and '628 Patents”). On November 28, 2012, Watson withdrew its ANDA, and, as a result of such withdrawal, on December 18, 2012, we and Purdue agreed to voluntarily dismiss the action without prejudice and on December 20, 2012 a court order was entered to such effect. The dismissal of Watson's ANDA had no effect on the ANDA filed by Actavis, a wholly owned subsidiary of Watson Pharmaceuticals, Inc. On January 24, 2013, Actavis notified us that it has included Paragraph IV patent certifications to our U.S. Patent Nos. 8,242,131 (expiring August 20, 2029) and 8,252,809 (expiring February 16, 2025) (together, the “'131 and '809 Patents”).
|
•
|
Novel: In the July 2012 notifications, Novel indicated that its ANDA includes Paragraph IV patent certifications to the '945 and '628 Patents. On December 10, 2012, Novel notified us that it has included Paragraph IV patent certifications to the '131 and '809 Patents.
|
•
|
Par Entities: The ANDAs submitted by the Par Entities each include Paragraph IV patent certifications to the '945, '628, '131 and '809 Patents.
|
•
|
Dr. Reddy's: The ANDA submitted by Dr. Reddy's includes Paragraph IV patent certifications to the '945, '628, '131 and '809 Patents.
|
•
|
TWi: The ANDA submitted by TWi includes Paragraph IV patent certifications to the '945, '628, '131 and '809 Patents.
|
Item 1A.
|
Risk Factors
|
•
|
our ability to complete the merger with Paratek, including paying any dividends;
|
•
|
the timing and nature of any future strategic transactions that we undertake;
|
•
|
the level of Purdue Pharma's commercialization efforts with respect to Intermezzo;
|
•
|
the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights, including in connection with ANDA proceedings relating to Intermezzo;
|
•
|
the potential costs associated with Intermezzo if our existing Collaboration Agreement with Purdue is terminated, including the increased costs to us of litigation expense in connection with ANDA proceedings related to Intermezzo;
|
•
|
the receipt of milestone and other payments, if any, from Purdue Pharma under the Collaboration Agreement;
|
•
|
the receipt of payments, if any, from SNBL under the SNBL Termination Agreement;
|
•
|
the effect of competing technological and market developments; and
|
•
|
the cost incurred in responding to disruptive actions by activist stockholders.
|
•
|
the failure of our strategic initiatives to enhance stockholder value or delay in the completion of our merger with Paratek, including with respect to the amount and timing of any pre-closing and post-closing dividends;
|
•
|
our inability to sell our Intermezzo royalty rights and ex US marketing rights;
|
•
|
the effectiveness of the sales, marketing and distribution efforts by Purdue Pharma in the United States and overall success of Purdue Pharma's commercialization efforts in the United States;
|
•
|
delays or unexpected changes in Purdue Pharma's plan to invest in and support the sales and marketing of Intermezzo;
|
•
|
unexpected difficulties in Purdue Pharma's efforts to commercialize Intermezzo
in the United States;
|
•
|
the effectiveness of SNBL to commercialize or to license the TO-2070 assets, and our receipt of any proceeds pursuant to the SNBL Termination Agreement;
|
•
|
lower than expected pricing and reimbursement levels, or no reimbursement at all, for Intermezzo
in the United States;
|
•
|
the use of currently available sleep aids that are not approved to be taken in the middle of the night;
|
•
|
negative developments or setbacks in our efforts to seek marketing approval for Intermezzo
outside of the United States;
|
•
|
FDA approval of generic versions of Intermezzo or negative developments in any ongoing ANDA proceedings;
|
•
|
current and future competitive products that have or obtain greater acceptance in the market than Intermezzo;
|
•
|
if only a subset of or no affected patients respond to therapy with Intermezzo
or future products, if any;
|
•
|
negative publicity about the results of our clinical studies, or those of others with similar or related products may reduce demand for Intermezzo or future products, if any;
|
•
|
the inability to sell a product at the price we expect; or
|
•
|
the inability to supply enough product to meet demand.
|
•
|
announcements related to our merger with Paratek, and any pre-closing and post-closing dividends;
|
•
|
the initiation of, material developments in, or conclusion of litigation to enforce or defend our intellectual property rights or defend against the intellectual property rights of others;
|
•
|
the perception of our prospects for successful commercialization or a sale of Intermezzo
by Purdue Pharma;
|
•
|
announcements by us or Purdue Pharma regarding the commercialization and/or marketing efforts of Intermezzo;
|
•
|
the termination by Purdue Pharma of the Collaboration Agreement, or the termination of other future collaboration, partnering or license agreements;
|
•
|
the failure of our products to achieve commercial success, including due to competition from generic versions, or the perception by investors that commercial success may not be achieved;
|
•
|
issues in manufacturing our products;
|
•
|
the entry into any in-licensing agreements securing licenses, patents or development rights;
|
•
|
the entry into, or termination of, key agreements, including additional commercial partner agreements;
|
•
|
announcements by commercial partners or competitors of new commercial products, clinical progress or the lack thereof, significant contracts, commercial relationships or capital commitments;
|
•
|
adverse publicity relating to the insomnia or migraine markets, including with respect to other products and potential products in such markets;
|
•
|
the introduction of technological innovations or new therapies that compete with our potential products;
|
•
|
the loss of key employees;
|
•
|
changes in estimates or recommendations by securities analysts, if any, who cover our common stock;
|
•
|
future sales of our common stock;
|
•
|
general and industry-specific economic conditions that may affect our research and development expenditures;
|
•
|
changes in the structure of health care payment systems, including changes to prescription drug reimbursement levels; and
|
•
|
period-to-period fluctuations in financial results.
|
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
Item 3.
|
Defaults Upon Senior Securities
|
Item 4.
|
Mine Safety Disclosures
|
Item 5.
|
Other Information
|
Item 6.
|
Exhibits
|
|
Transcept Pharmaceuticals, Inc.
|
||
|
|
|
|
|
By:
|
|
/s/ Leone D. Patterson
|
|
|
|
Leone D. Patterson
Vice President, Chief Financial Officer
(Principal Financial and Accounting Officer)
|
Exhibit No.
|
|
Description of Exhibit
|
|
|
|
2.1(6)*
|
|
Agreement and Plan of Merger and Reorganization, dated as of June 30, 2014, by and among Transcept Pharmaceuticals, Inc., Tigris Merger Sub., Inc. and Paratek Pharmaceuticals, Inc.
|
|
|
|
2.2 (6)
|
|
Form of Support Agreement, by and between Transcept Pharmaceuticals, Inc. and certain stockholders of Paratek Pharmaceuticals, Inc.
|
|
|
|
2.3 (6)
|
|
Form of Support Agreement, by and between Paratek Pharmaceuticals, Inc. and certain stockholders of Transcept Pharmaceuticals, Inc.
|
|
|
|
3.1(1)
|
|
Amended and Restated Certificate of Incorporation of Transcept Pharmaceuticals, Inc.
|
|
|
|
3.2(1)
|
|
Bylaws of Transcept Pharmaceuticals, Inc., as amended.
|
|
|
|
3.3(2)
|
|
Certificate of Designations of Series A Junior Participating Preferred Stock of Transcept Pharmaceuticals, Inc.
|
|
|
|
4.1(3)
|
|
Specimen Common Stock certificate of Transcept Pharmaceuticals, Inc.
|
|
|
|
4.2(3)
|
|
Form of Preferred Stock Purchase Warrant issued to certain TPI investors as of March 21, 2005.
|
|
|
|
4.3(3)
|
|
Preferred Stock Purchase Warrant issued by TPI to Hercules Technology Growth Capital, Inc., dated as of April 13, 2006.
|
|
|
|
4.4(4)
|
|
2005 Amended and Restated Investor Rights Agreement, dated as of December 21, 2005, by and between Novacea and purchasers of Novacea Series A, Series B and Series C Preferred Stock.
|
|
|
|
4.5(5)
|
|
Amended and Restated Investor Rights Agreement, dated as of February 27, 2007, by and between TPI and purchasers of TPI Series A, Series B, Series C and Series D Preferred Stock.
|
|
|
|
4.6(5)
|
|
Termination Agreement, dated as of January 26, 2009, by and between TPI and purchasers of TPI Series A, Series B, Series C and Series D Preferred Stock.
|
|
|
|
4.7(2)
|
|
Tax Benefit Preservation Plan, dated as of September 13, 2013, between Transcept Pharmaceuticals, Inc. and American Stock Transfer & Trust Company, LLC, which includes the Form of Certificate of Designations of Series A Junior Participating Preferred Stock as Exhibit A, the Form of Right Certificate as Exhibit B and the Summary of Rights to Purchase Preferred Shares as Exhibit C
|
|
|
|
10.1
|
|
Termination Agreement and Release, dates as of September 19, 2014, between Transcept Pharmaceuticals, Inc. and Shin Nippon Biomedical Laboratories, Ltd.
|
|
|
|
31.1
|
|
Certification of the Company’s Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
31.2
|
|
Certification of the Company’s Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.1**
|
|
Certification of the Company’s Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
101
|
|
The following materials from Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, formatted in Extensible Business Reporting Language (XBRL) includes: (i) Condensed Consolidated Balance Sheets at September 30, 2014 and December 31, 2013, (ii) Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2014 and 2013, (iii) Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2014 and 2013 and (iv) Notes to Condensed Consolidated Financial Statements.
|
|
|
|
(1)
|
Incorporated by reference from the Current Report on Form 8-K filed with the Securities and Exchange Commission on February 5, 2009.
|
(2)
|
Incorporated by reference from the Current Report on Form 8-K filed with the Securities and Exchange Commission on September 13, 2013.
|
(3)
|
Incorporated by reference from the Current Report on Form 8-K filed with the Securities and Exchange Commission on February 5, 2009.
|
(4)
|
Incorporated by reference from the Registration Statement on Form S-1, Securities and Exchange Commission file number 333-131741, filed on February 10, 2006.
|
(5)
|
Incorporated by reference from the Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 14, 2010.
|
(6)
|
Incorporated by reference from the Current Report on Form 8-K filed with the Securities and Exchange Commission on July 1, 2014.
|
*
|
All schedules and exhibits to the Merger Agreement have been omitted pursuant to Item 601(b)(2) of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the Securities and Exchange Commission upon request.
|
|
|
**
|
The certification attached as Exhibit 32.1 that accompanies this Quarterly Report on Form 10-Q is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Transcept Pharmaceuticals, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-Q, irrespective of any general incorporation language contained in such filing.
|
Net Licensing Revenue
|
Percentage of Net Licensing Revenue
|
Any Net Licensing Revenue paid to SNBL as up-front license payment(s)
|
15% of such up-front license payment(s), or $150,000, whichever is greater
|
Any Net Licensing Revenue (other than up-front license payments)
|
30%, up to a cumulative maximum amount paid to Transcept equal to U.S. $0.5 million
|
Any Net Licensing Revenue (other than up-front license payments) after payment to Transcept of a cumulative maximum amount equal to U.S. $0.5 million
|
5%, up to a cumulative maximum amount paid to Transcept equal to U.S. $2.0 million
|
|
/s/
|
Glenn A. Oclassen
|
|
Glenn A. Oclassen
President and Chief Executive Officer
(Principal Executive Officer)
|
|
/s/
|
Leone D. Patterson
|
|
Leone D. Patterson
Vice President, Finance and Chief Financial Officer
(Principal Financial Officer)
|
|
/s/ Glenn A. Oclassen
|
|
Glenn A. Oclassen
President and Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
/s/ Leone D. Patterson
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Leone D. Patterson
Vice President, Finance and Chief Financial Officer
(Principal Financial Officer)
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