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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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¨
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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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51-0619477
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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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5 Sylvan Way, Suite 100
Parsippany, New Jersey, 07054
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(Address of Principal Executive Offices and Zip Code)
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(973) 254-3560
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(Registrant's Telephone Number, Including Area Code)
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Large accelerated filer
o
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Accelerated filer
x
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Non-accelerated filer
o
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Smaller reporting company
o
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(Do not check if a smaller reporting company)
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PACIRA PHARMACEUTICALS, INC.
TABLE OF CONTENTS
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Page #
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PACIRA PHARMACEUTICALS, INC.
(Unaudited)
(In thousands, except share and per share amounts)
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|||||||
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June 30,
2014 |
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December 31,
2013 |
||||
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(Note 2)
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||||
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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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108,200
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$
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12,515
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Restricted cash
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2,168
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|
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1,633
|
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Short-term investments
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55,660
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59,637
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Accounts receivable, net
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20,545
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14,590
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||
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Inventories
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19,194
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15,557
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Prepaid expenses and other current assets
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3,139
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|
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2,819
|
|
||
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Total current assets
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208,906
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106,751
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Long-term investments
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13,474
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—
|
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Fixed assets, net
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53,513
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48,182
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Goodwill
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12,520
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10,328
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Intangibles, net
|
564
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1,157
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Other assets
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3,103
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|
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3,402
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||
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Total assets
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$
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292,080
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$
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169,820
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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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3,145
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$
|
3,069
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Accrued expenses
|
23,035
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|
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17,885
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|
||
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Convertible senior notes
|
101,031
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98,961
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|
||
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Current portion of royalty interest obligation
|
869
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|
|
1,020
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|
||
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Current portion of deferred revenue
|
1,426
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|
|
1,008
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|
||
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Total current liabilities
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129,506
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|
|
121,943
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|
||
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Royalty interest obligation
|
—
|
|
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226
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|
||
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Deferred revenue
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10,221
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3,212
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Other liabilities
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4,384
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3,190
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Total liabilities
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144,111
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128,571
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||
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Commitments and contingencies (Note 12)
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Stockholders’ equity:
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Preferred stock, par value $0.001; 5,000,000 shares authorized, none issued and outstanding at
June 30, 2014 and December 31, 2013 |
—
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—
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Common stock, par value $0.001, 250,000,000 shares authorized; 35,836,959 shares issued and
outstanding at June 30, 2014; 33,636,442 shares issued and outstanding at December 31, 2013 |
36
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34
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Additional paid-in capital
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460,907
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337,639
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Accumulated deficit
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(312,943
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)
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(296,429
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)
|
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Accumulated other comprehensive income (loss)
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(31
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)
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5
|
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Total stockholders’ equity
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147,969
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41,249
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Total liabilities and stockholders’ equity
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$
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292,080
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$
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169,820
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PACIRA PHARMACEUTICALS, INC.
(Unaudited)
(In thousands, except per share amounts)
|
|||||||||||||||
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Three Months Ended
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Six Months Ended
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||||||||||||
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June 30,
|
|
June 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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Revenues:
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Net product sales
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$
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46,034
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$
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16,278
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$
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81,776
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$
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27,113
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Collaborative licensing and development revenue
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322
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243
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574
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486
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Royalty revenue
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809
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620
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1,478
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1,129
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||||
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Total revenues
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47,165
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17,141
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83,828
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28,728
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Operating expenses:
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Cost of goods sold
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19,954
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10,214
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38,081
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21,605
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Research and development
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5,216
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4,857
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10,420
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10,762
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Selling, general and administrative
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24,837
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14,080
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47,426
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27,017
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Total operating expenses
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50,007
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29,151
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95,927
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59,384
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Loss from operations
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(2,842
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)
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(12,010
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)
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(12,099
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)
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(30,656
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)
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||||
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Other (expense) income:
|
|
|
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|
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|
|
|
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|
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||||
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Interest income
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61
|
|
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72
|
|
|
103
|
|
|
145
|
|
||||
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Interest expense
|
(2,079
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)
|
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(1,914
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)
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(4,185
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)
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(3,433
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)
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||||
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Loss on early extinguishment of debt
|
—
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|
|
—
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—
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(3,398
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)
|
||||
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Royalty interest obligation
|
(136
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)
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|
(161
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)
|
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(256
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)
|
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(247
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)
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||||
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Other, net
|
(41
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)
|
|
(18
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)
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(77
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)
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(22
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)
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||||
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Total other expense, net
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(2,195
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)
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|
(2,021
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)
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(4,415
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)
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(6,955
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)
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||||
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Loss before income taxes
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(5,037
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)
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(14,031
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)
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(16,514
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)
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(37,611
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)
|
||||
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Income tax benefit
|
—
|
|
|
—
|
|
|
—
|
|
|
442
|
|
||||
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Net loss
|
$
|
(5,037
|
)
|
|
$
|
(14,031
|
)
|
|
$
|
(16,514
|
)
|
|
$
|
(37,169
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)
|
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|
|
|
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|
||||||||
|
Net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Basic and diluted net loss per common share
|
$
|
(0.14
|
)
|
|
$
|
(0.42
|
)
|
|
$
|
(0.48
|
)
|
|
$
|
(1.13
|
)
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Basic and diluted
|
35,463
|
|
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33,083
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34,587
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32,896
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|
||||
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
(In thousands)
|
|||||||||||||||
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
|
June 30,
|
|
June 30,
|
||||||||||||
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
|
Net loss
|
$
|
(5,037
|
)
|
|
$
|
(14,031
|
)
|
|
$
|
(16,514
|
)
|
|
$
|
(37,169
|
)
|
|
Other comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Net unrealized loss on investments
|
(36
|
)
|
|
(31
|
)
|
|
(36
|
)
|
|
(14
|
)
|
||||
|
Total other comprehensive loss
|
(36
|
)
|
|
(31
|
)
|
|
(36
|
)
|
|
(14
|
)
|
||||
|
Comprehensive loss
|
$
|
(5,073
|
)
|
|
$
|
(14,062
|
)
|
|
$
|
(16,550
|
)
|
|
$
|
(37,183
|
)
|
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
For the Six Months Ended June 30, 2014
(Unaudited)
(In thousands)
|
||||||||||||||||||||||
|
|
Common Stock
|
|
Additional
Paid-In Capital |
|
Accumulated
Deficit |
|
Accumulated
Other Comprehensive Income (Loss) |
|
|
|||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
|
Total
|
||||||||||||||
|
Balances at December 31, 2013
|
33,636
|
|
|
$
|
34
|
|
|
$
|
337,639
|
|
|
$
|
(296,429
|
)
|
|
$
|
5
|
|
|
$
|
41,249
|
|
|
Follow-on public offering, net
|
1,840
|
|
|
2
|
|
|
110,405
|
|
|
—
|
|
|
—
|
|
|
110,407
|
|
|||||
|
Exercise of stock options
|
326
|
|
|
—
|
|
|
3,351
|
|
|
—
|
|
|
—
|
|
|
3,351
|
|
|||||
|
Cashless exercise of warrants
|
35
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
9,512
|
|
|
—
|
|
|
—
|
|
|
9,512
|
|
|||||
|
Net unrealized loss on investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(36
|
)
|
|
(36
|
)
|
|||||
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(16,514
|
)
|
|
—
|
|
|
(16,514
|
)
|
|||||
|
Balances at June 30, 2014
|
35,837
|
|
|
$
|
36
|
|
|
$
|
460,907
|
|
|
$
|
(312,943
|
)
|
|
$
|
(31
|
)
|
|
$
|
147,969
|
|
|
PACIRA PHARMACEUTICALS, INC.
(Unaudited)
(In thousands)
|
|||||||
|
|
Six Months Ended
|
||||||
|
|
June 30,
|
||||||
|
|
2014
|
|
2013
|
||||
|
Operating activities:
|
|
|
|
|
|
||
|
Net loss
|
$
|
(16,514
|
)
|
|
$
|
(37,169
|
)
|
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
|
|
|
|
|
|
||
|
Depreciation of fixed assets and amortization of intangibles
|
4,936
|
|
|
2,717
|
|
||
|
Amortization of unfavorable lease obligation and debt issuance costs
|
243
|
|
|
216
|
|
||
|
Amortization of debt discount
|
2,069
|
|
|
1,890
|
|
||
|
Loss on disposal of fixed assets
|
157
|
|
|
31
|
|
||
|
Loss on early extinguishment of debt
|
—
|
|
|
3,398
|
|
||
|
Stock-based compensation
|
9,512
|
|
|
4,450
|
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
||
|
Restricted cash
|
(535
|
)
|
|
525
|
|
||
|
Accounts receivable, net
|
(5,955
|
)
|
|
(3,403
|
)
|
||
|
Inventories
|
(3,637
|
)
|
|
(2,144
|
)
|
||
|
Prepaid expenses and other assets
|
(332
|
)
|
|
(711
|
)
|
||
|
Accounts payable and accrued expenses
|
5,226
|
|
|
3,260
|
|
||
|
Royalty interest obligation
|
(377
|
)
|
|
(205
|
)
|
||
|
Other liabilities
|
1,263
|
|
|
532
|
|
||
|
Deferred revenue
|
7,426
|
|
|
(486
|
)
|
||
|
Net cash provided by (used in) operating activities
|
3,482
|
|
|
(27,099
|
)
|
||
|
Investing activities:
|
|
|
|
|
|
||
|
Purchases of fixed assets
|
(9,831
|
)
|
|
(4,672
|
)
|
||
|
Purchases of short-term investments
|
(52,992
|
)
|
|
(87,220
|
)
|
||
|
Sales of short-term investments
|
56,941
|
|
|
30,800
|
|
||
|
Purchases of long-term investments
|
(13,481
|
)
|
|
—
|
|
||
|
Payment of contingent consideration
|
(2,192
|
)
|
|
(682
|
)
|
||
|
Net cash used in investing activities
|
(21,555
|
)
|
|
(61,774
|
)
|
||
|
Financing activities:
|
|
|
|
|
|
||
|
Proceeds from follow-on public offering, net
|
110,407
|
|
|
—
|
|
||
|
Proceeds from exercise of stock options and warrants
|
3,351
|
|
|
2,064
|
|
||
|
Proceeds from convertible senior notes
|
—
|
|
|
120,000
|
|
||
|
Repayment of debt
|
—
|
|
|
(27,500
|
)
|
||
|
Payment of debt issuance and financing costs
|
—
|
|
|
(7,191
|
)
|
||
|
Net cash provided by financing activities
|
113,758
|
|
|
87,373
|
|
||
|
Net increase (decrease) in cash and cash equivalents
|
95,685
|
|
|
(1,500
|
)
|
||
|
Cash and cash equivalents, beginning of period
|
12,515
|
|
|
10,126
|
|
||
|
Cash and cash equivalents, end of period
|
$
|
108,200
|
|
|
$
|
8,626
|
|
|
Supplemental cash flow information:
|
|
|
|
|
|
||
|
Cash paid for interest, including royalty interest obligation
|
$
|
2,583
|
|
|
$
|
846
|
|
|
Non-cash investing and financing activities:
|
|
|
|
|
|
||
|
Equity component of convertible senior notes
|
$
|
—
|
|
|
$
|
24,936
|
|
|
|
Three Months Ended
|
|
Six Months Ended
|
||||
|
|
June 30,
|
|
June 30,
|
||||
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
Largest customer
|
33%
|
|
35%
|
|
33%
|
|
35%
|
|
Second largest customer
|
29%
|
|
27%
|
|
29%
|
|
27%
|
|
Third largest customer
|
23%
|
|
17%
|
|
23%
|
|
17%
|
|
|
85%
|
|
79%
|
|
85%
|
|
79%
|
|
|
June 30,
|
|
December 31,
|
||||
|
|
2014
|
|
2013
|
||||
|
Raw materials
|
$
|
7,369
|
|
|
$
|
5,290
|
|
|
Work-in-process
|
5,470
|
|
|
6,321
|
|
||
|
Finished goods
|
6,355
|
|
|
3,946
|
|
||
|
Total
|
$
|
19,194
|
|
|
$
|
15,557
|
|
|
|
June 30,
|
|
December 31,
|
||||
|
|
2014
|
|
2013
|
||||
|
Machinery and laboratory equipment
|
$
|
22,148
|
|
|
$
|
19,570
|
|
|
Computer equipment and software
|
3,071
|
|
|
2,476
|
|
||
|
Office furniture and equipment
|
479
|
|
|
441
|
|
||
|
Leasehold improvements
|
25,902
|
|
|
24,852
|
|
||
|
Construction in progress
|
17,237
|
|
|
13,419
|
|
||
|
Total
|
68,837
|
|
|
60,758
|
|
||
|
Less accumulated depreciation
|
(15,324
|
)
|
|
(12,576
|
)
|
||
|
Fixed assets, net
|
$
|
53,513
|
|
|
$
|
48,182
|
|
|
(i)
|
$10.0 million
upon first commercial sale in the United States;
|
|
(ii)
|
$4.0 million
upon first commercial sale in a major EU country (United Kingdom, France, Germany, Italy and Spain);
|
|
(iii)
|
$8.0 million
when annual net sales collected reach
$100.0 million
;
|
|
(iv)
|
$8.0 million
when annual net sales collected reach
$250.0 million
; and
|
|
(v)
|
$32.0 million
when annual net sales collected reach
$500.0 million
.
|
|
Balance at December 31, 2013
|
|
$
|
10,328
|
|
|
Percentage payments on net sales of EXPAREL collected
|
|
2,192
|
|
|
|
Balance at June 30, 2014
|
|
$
|
12,520
|
|
|
June 30, 2014
|
|
Gross
Carrying Value |
|
Accumulated
Amortization |
|
Intangible
Assets, Net |
|
Estimated
Useful Life |
||||||
|
Amortizable intangible assets:
|
|
|
|
|
|
|
|
|
||||||
|
Core technology
|
|
$
|
2,900
|
|
|
$
|
(2,336
|
)
|
|
$
|
564
|
|
|
9 Years
|
|
Developed technology
|
|
11,700
|
|
|
(11,700
|
)
|
|
—
|
|
|
7 Years
|
|||
|
Trademarks and trade names
|
|
400
|
|
|
(400
|
)
|
|
—
|
|
|
7 Years
|
|||
|
Total intangible assets
|
|
$
|
15,000
|
|
|
$
|
(14,436
|
)
|
|
$
|
564
|
|
|
|
|
December 31, 2013
|
|
Gross
Carrying Value |
|
Accumulated
Amortization |
|
Intangible
Assets, Net |
|
Estimated
Useful Life |
||||||
|
Amortizable intangible assets:
|
|
|
|
|
|
|
|
|
||||||
|
Core technology
|
|
$
|
2,900
|
|
|
$
|
(2,175
|
)
|
|
$
|
725
|
|
|
9 Years
|
|
Developed technology
|
|
11,700
|
|
|
(11,282
|
)
|
|
418
|
|
|
7 Years
|
|||
|
Trademarks and trade names
|
|
400
|
|
|
(386
|
)
|
|
14
|
|
|
7 Years
|
|||
|
Total intangible assets
|
|
$
|
15,000
|
|
|
$
|
(13,843
|
)
|
|
$
|
1,157
|
|
|
|
|
|
Total
|
||
|
2014 (remaining six months)
|
$
|
161
|
|
|
2015
|
322
|
|
|
|
2016
|
81
|
|
|
|
Total
|
$
|
564
|
|
|
|
June 30,
|
|
December 31,
|
||||
|
|
2014
|
|
2013
|
||||
|
Debt:
|
|
|
|
||||
|
Convertible senior notes
|
$
|
120,000
|
|
|
$
|
120,000
|
|
|
Discount on debt
|
(18,969
|
)
|
|
(21,039
|
)
|
||
|
Total debt, net of debt discount
|
101,031
|
|
|
98,961
|
|
||
|
Royalty interest obligation
|
869
|
|
|
1,246
|
|
||
|
Total debt and financing obligations
|
$
|
101,900
|
|
|
$
|
100,207
|
|
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
|
June 30,
|
|
June 30,
|
||||||||||||
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
|
Contractual interest expense
|
$
|
975
|
|
|
$
|
975
|
|
|
$
|
1,950
|
|
|
$
|
1,723
|
|
|
Amortization of debt issuance costs
|
155
|
|
|
155
|
|
|
310
|
|
|
274
|
|
||||
|
Amortization of debt discount
|
1,035
|
|
|
1,035
|
|
|
2,069
|
|
|
1,828
|
|
||||
|
|
$
|
2,165
|
|
|
$
|
2,165
|
|
|
$
|
4,329
|
|
|
$
|
3,825
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Effective interest rate
|
7.22
|
%
|
|
7.22
|
%
|
|
7.22
|
%
|
|
7.22
|
%
|
||||
|
•
|
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—Observable prices that are based on inputs not quoted on active markets, but corroborated by market data.
|
|
•
|
Level 3—Unobservable inputs that are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
|
|
|
|
Carrying Value
|
|
Fair Value Measurements Using
|
||||||||||||
|
Financial Liabilities Carried at Historical Cost
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|||||||||
|
June 30, 2014
|
|
|
|
|
|
|
|
|
||||||||
|
Convertible senior notes *
|
|
$
|
101,031
|
|
|
$
|
—
|
|
|
$
|
448,050
|
|
|
$
|
—
|
|
|
June 30, 2014
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
(Level 2) |
||||||||
|
Debt securities:
|
|
|
|
|
|
|
|
|
||||||||
|
Short-term
|
|
|
|
|
|
|
|
|
||||||||
|
Commercial paper
|
|
$
|
12,264
|
|
|
$
|
10
|
|
|
$
|
—
|
|
|
$
|
12,274
|
|
|
Corporate bonds
|
|
43,420
|
|
|
2
|
|
|
(36
|
)
|
|
43,386
|
|
||||
|
Subtotal
|
|
55,684
|
|
|
12
|
|
|
(36
|
)
|
|
55,660
|
|
||||
|
Long-term
|
|
|
|
|
|
|
|
|
||||||||
|
Corporate bonds
|
|
13,481
|
|
|
2
|
|
|
(9
|
)
|
|
13,474
|
|
||||
|
Total
|
|
$
|
69,165
|
|
|
$
|
14
|
|
|
$
|
(45
|
)
|
|
$
|
69,134
|
|
|
December 31, 2013
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
(Level 2) |
||||||||
|
Debt securities:
|
|
|
|
|
|
|
|
|
||||||||
|
Commercial paper
|
|
$
|
17,986
|
|
|
$
|
11
|
|
|
$
|
—
|
|
|
$
|
17,997
|
|
|
Corporate bonds
|
|
30,808
|
|
|
1
|
|
|
(7
|
)
|
|
30,802
|
|
||||
|
Asset-backed securities
|
|
10,838
|
|
|
1
|
|
|
(1
|
)
|
|
10,838
|
|
||||
|
Total
|
|
$
|
59,632
|
|
|
$
|
13
|
|
|
$
|
(8
|
)
|
|
$
|
59,637
|
|
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
|
June 30,
|
|
June 30,
|
||||||||||||
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
|
Cost of goods sold
|
$
|
641
|
|
|
$
|
391
|
|
|
$
|
1,135
|
|
|
$
|
626
|
|
|
Research and development
|
2,137
|
|
|
509
|
|
|
3,714
|
|
|
1,465
|
|
||||
|
Selling, general and administrative
|
2,759
|
|
|
1,325
|
|
|
4,663
|
|
|
2,359
|
|
||||
|
Total
|
$
|
5,537
|
|
|
$
|
2,225
|
|
|
$
|
9,512
|
|
|
$
|
4,450
|
|
|
Stock Incentive Plan
|
|
Awards Reserved for Issuance
|
|
Awards Issued
|
|
Awards Available for Grant
|
|||
|
2007 Stock incentive plan
|
|
2,022,862
|
|
|
2,022,862
|
|
|
—
|
|
|
Amended and restated 2011 stock incentive plan
|
|
5,931,675
|
|
|
4,306,663
|
|
|
1,625,012
|
|
|
2014 Inducement plan
|
|
175,000
|
|
|
80,000
|
|
|
95,000
|
|
|
|
|
8,129,537
|
|
|
6,409,525
|
|
|
1,720,012
|
|
|
Employee Stock Purchase Plan
|
|
Shares Reserved for Purchase
|
|
Shares Purchased
|
|
Shares Available for Purchase
|
|||
|
2014 Employee stock purchase plan
|
|
500,000
|
|
|
—
|
|
|
500,000
|
|
|
|
Number of Shares
|
|
Weighted Average Exercise Price
|
|||
|
Outstanding at December 31, 2013
|
3,840,038
|
|
|
$
|
13.50
|
|
|
Granted
|
1,458,200
|
|
|
77.92
|
|
|
|
Exercised
|
(326,290
|
)
|
|
10.28
|
|
|
|
Forfeited
|
(86,753
|
)
|
|
31.11
|
|
|
|
Expired
|
(237
|
)
|
|
15.24
|
|
|
|
Outstanding at June 30, 2014
|
4,884,958
|
|
|
$
|
32.64
|
|
|
|
|
Six Months Ended
|
||||||
|
|
|
June 30,
|
||||||
|
|
|
2014
|
|
2013
|
||||
|
Net unrealized gains (losses) from available for sale investments:
|
|
|
|
|
||||
|
Balance at beginning of period
|
|
$
|
5
|
|
|
$
|
27
|
|
|
Other comprehensive loss before reclassifications
|
|
(36
|
)
|
|
(14
|
)
|
||
|
Amounts reclassified from accumulated other comprehensive income
|
|
—
|
|
|
—
|
|
||
|
Balance at end of period
|
|
$
|
(31
|
)
|
|
$
|
13
|
|
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
June 30,
|
|
June 30,
|
|||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|||||||||
|
Numerator:
|
|
|
|
|
|
|
|
||||||||
|
Net loss
|
$
|
(5,037
|
)
|
|
$
|
(14,031
|
)
|
|
$
|
(16,514
|
)
|
|
$
|
(37,169
|
)
|
|
Denominator:
|
|
|
|
|
|
|
|
||||||||
|
Weighted average shares of common stock outstanding
|
35,463
|
|
|
33,083
|
|
|
34,587
|
|
|
32,896
|
|
||||
|
Net loss per share:
|
|
|
|
|
|
|
|
||||||||
|
Basic and diluted net loss per share of common stock
|
$
|
(0.14
|
)
|
|
$
|
(0.42
|
)
|
|
$
|
(0.48
|
)
|
|
$
|
(1.13
|
)
|
|
|
Three Months Ended June 30, 2014
|
|
Six Months Ended June 30, 2014
|
||
|
Weighted average number of stock options outstanding
|
4,146
|
|
|
4,006
|
|
|
Conversion premium on the Notes
|
3,259
|
|
|
3,165
|
|
|
Weighted average number of warrants outstanding
|
46
|
|
|
52
|
|
|
Total
|
7,451
|
|
|
7,223
|
|
|
Year
|
|
|
||
|
2014 (remaining six months)
|
|
$
|
2,518
|
|
|
2015
|
|
5,297
|
|
|
|
2016
|
|
5,436
|
|
|
|
2017
|
|
5,578
|
|
|
|
2018
|
|
5,725
|
|
|
|
2019 through 2028
|
|
15,899
|
|
|
|
Total
|
|
$
|
40,453
|
|
|
•
|
EXPAREL is a liposome injection of bupivacaine, an amide-type local anesthetic indicated for administration into the surgical site to produce postsurgical analgesia, and was approved by the FDA on October 28, 2011. We commercially launched EXPAREL in April 2012. We drop-ship EXPAREL directly to the end user based on orders placed to wholesalers or directly to us, and we have no product held by wholesalers.
|
|
•
|
DepoCyt(e) is a sustained release liposomal formulation of the chemotherapeutic agent cytarabine and is indicated for the intrathecal treatment of lymphomatous meningitis. DepoCyt(e) was granted accelerated approval by the FDA in 1999 and full approval in 2007. We sell DepoCyt(e) to our commercial partners located in the U.S. and Europe.
|
|
•
|
Since the commercial launch of EXPAREL in April 2012, 2,815 accounts have ordered EXPAREL, 363 of which were added during the quarter ended
June 30, 2014
. The growing demand for EXPAREL is largely due to growth within existing accounts and increasing acceptance by major hospitals and orthopedic centers as a result of the rapid adoption of EXPAREL in orthopedic procedures as well as continued adoption of transversus abdominis plane, or TAP, infiltration procedures for abdominal and genitourinary surgeries.
|
|
•
|
Total revenues increased $30.0 million, or 175%, in the quarter ended
June 30, 2014
, as compared to the same period in 2013, primarily driven by EXPAREL product sales of $44.9 million.
|
|
•
|
In March 2014, the FDA approved an additional bulk manufacturing suite, or Suite C, for EXPAREL, which will more than double our manufacturing capacity.
|
|
•
|
In April 2014, we and Patheon UK Limited, or Patheon, entered into a Strategic Co-Production Agreement, Technical Transfer and Service Agreement and Manufacturing Supply Agreement to collaborate in the manufacture and packaging of EXPAREL. Patheon has agreed to undertake certain technical transfer activities and construction services needed to prepare its Swindon, United Kingdom facility for the manufacture and packaging of EXPAREL in two dedicated manufacturing suites. We expect the first suite to begin commercial production in the second half of 2016. We expect that the expansion of our manufacturing capacity with Patheon, coupled with our manufacturing facility at our Science Center Campus, will enable us to meet the growing demand for EXPAREL.
|
|
•
|
In April 2014, we completed an underwritten public offering, selling 1,840,000 shares of common stock, which included the underwriters’ exercise of the over-allotment option, at an offering price of $64.00 per share. We received net proceeds after underwriting fees and related expenses of $110.4 million.
|
|
•
|
In April 2014, we and Mundipharma International Corporation Limited, or Mundipharma, amended our agreements to, among other things, (i) extend the term of such agreements by an additional 15 years to June 2033 and (ii) expand the territory where Mundipharma can market and distribute DepoCyte to all countries other than the United States of America, Canada, and Japan. In connection with the agreements, we received a non-refundable upfront payment of $8.0 million from Mundipharma. The revenue has been deferred and will be recognized over the remaining contractual term.
|
|
•
|
In May 2014, we announced the submission of an sNDA for a nerve block indication based on data from a Phase 3 study demonstrating the efficacy and safety of EXPAREL in femoral nerve block for total knee arthroplasty, as well as data from a Phase 3 study in intercostal nerve block for thoracotomy. The FDA has accepted our sNDA for review and has set a Prescription Drug User Fee Act action date of March 5, 2015.
|
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
|
Six Months Ended
|
|
% Increase / (Decrease)
|
||||||||||||
|
|
June 30,
|
|
|
June 30,
|
|
||||||||||||||
|
|
2014
|
|
2013
|
|
|
2014
|
|
2013
|
|
||||||||||
|
Net product sales:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
EXPAREL
|
$
|
44,914
|
|
|
$
|
15,223
|
|
|
195%
|
|
$
|
79,316
|
|
|
$
|
25,664
|
|
|
209%
|
|
DepoCyt(e)
|
1,120
|
|
|
1,055
|
|
|
6%
|
|
2,460
|
|
|
1,449
|
|
|
70%
|
||||
|
Total net product sales
|
46,034
|
|
|
16,278
|
|
|
183%
|
|
81,776
|
|
|
27,113
|
|
|
202%
|
||||
|
Collaborative licensing and development revenue
|
322
|
|
|
243
|
|
|
33%
|
|
574
|
|
|
486
|
|
|
18%
|
||||
|
Royalty revenue
|
809
|
|
|
620
|
|
|
30%
|
|
1,478
|
|
|
1,129
|
|
|
31%
|
||||
|
Total revenues
|
$
|
47,165
|
|
|
$
|
17,141
|
|
|
175%
|
|
$
|
83,828
|
|
|
$
|
28,728
|
|
|
192%
|
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
|
Six Months Ended
|
|
% Increase / (Decrease)
|
||||||||||||
|
|
June 30,
|
|
|
June 30,
|
|
||||||||||||||
|
|
2014
|
|
2013
|
|
|
2014
|
|
2013
|
|
||||||||||
|
Cost of goods sold
|
$
|
19,954
|
|
|
$
|
10,214
|
|
|
95%
|
|
$
|
38,081
|
|
|
$
|
21,605
|
|
|
76%
|
|
Gross margin *
|
57
|
%
|
|
40
|
%
|
|
|
|
54
|
%
|
|
24
|
%
|
|
|
||||
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
|
Six Months Ended
|
|
% Increase / (Decrease)
|
||||||||||||
|
|
June 30,
|
|
|
June 30,
|
|
||||||||||||||
|
|
2014
|
|
2013
|
|
|
2014
|
|
2013
|
|
||||||||||
|
Research and development expense
|
$
|
5,216
|
|
|
$
|
4,857
|
|
|
7%
|
|
$
|
10,420
|
|
|
$
|
10,762
|
|
|
(3)%
|
|
•
|
Salaries and benefits increased by $1.7 million, which was almost entirely attributable to the revaluation of stock options held by consultants; and
|
|
•
|
Clinical development expenses decreased by $1.3 million primarily relating to the conclusion of our Phase 3 pivotal trial of EXPAREL administered as an intercostal nerve block for thoracotomy in August 2013 and our
|
|
•
|
Clinical development expenses decreased by $2.7 million relating to the conclusion of our Phase 3 pivotal trial of EXPAREL administered as an intercostal nerve block for thoracotomy in August 2013 and our Phase 2/3 pivotal trial of EXPAREL administered as a femoral nerve block for total knee arthroplasty in February 2014;
|
|
•
|
Salaries and benefits increased by $2.3 million, which was almost entirely attributable to the revaluation of stock options held by consultants.
|
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
|
Six Months Ended
|
|
% Increase / (Decrease)
|
||||||||||||
|
|
June 30,
|
|
|
June 30,
|
|
||||||||||||||
|
|
2014
|
|
2013
|
|
|
2014
|
|
2013
|
|
||||||||||
|
General and administrative
|
$
|
7,867
|
|
|
$
|
4,655
|
|
|
69%
|
|
$
|
15,297
|
|
|
$
|
9,331
|
|
|
64%
|
|
Sales and marketing
|
16,970
|
|
|
9,425
|
|
|
80%
|
|
32,129
|
|
|
17,686
|
|
|
82%
|
||||
|
Total selling, general and administrative expense
|
$
|
24,837
|
|
|
$
|
14,080
|
|
|
76%
|
|
$
|
47,426
|
|
|
$
|
27,017
|
|
|
76%
|
|
•
|
General and administrative expenses increased by
$3.2
million, due to increases in salaries and benefits associated with our increased headcount, and other regulatory, legal and support initiatives to support the commercial and manufacturing growth of EXPAREL; and
|
|
•
|
Sales and marketing expenses increased by
$7.5
million due to $4.4 million in project spend for EXPAREL, which included educational initiatives and programs to create product awareness in the orthopedic and soft tissue markets, commission based payments to CrossLink BioScience, LLC, or CrossLink, and selling and promotional activities to support the growth of EXPAREL. Salaries and benefits increased $3.1 million primarily driven by an increase in our sales force and field-based medical health science personnel.
|
|
•
|
General and administrative expenses increased by
$6.0
million, due to increases in salaries and benefits associated with our increased headcount, and other regulatory, legal and support initiatives to support the commercial and manufacturing growth of EXPAREL; and
|
|
•
|
Sales and marketing expenses increased by
$14.4
million due to $8.5 million in project spend for EXPAREL, which included educational initiatives and programs to create product awareness in the orthopedic and soft tissue markets, commission based payments to CrossLink and selling and promotional activities to support the growth of EXPAREL. Salaries and benefits increased $5.9 million primarily driven by an increase in our sales force and field-based medical health science personnel.
|
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
|
Six Months Ended
|
|
% Increase / (Decrease)
|
||||||||||||
|
|
June 30,
|
|
|
June 30,
|
|
||||||||||||||
|
|
2014
|
|
2013
|
|
|
2014
|
|
2013
|
|
||||||||||
|
Interest income
|
$
|
61
|
|
|
$
|
72
|
|
|
(15)%
|
|
$
|
103
|
|
|
$
|
145
|
|
|
(29)%
|
|
Interest expense
|
(2,079
|
)
|
|
(1,914
|
)
|
|
9%
|
|
(4,185
|
)
|
|
(3,433
|
)
|
|
22%
|
||||
|
Loss on early extinguishment of debt
|
—
|
|
|
—
|
|
|
N/A
|
|
—
|
|
|
(3,398
|
)
|
|
(100)%
|
||||
|
Royalty interest obligation
|
(136
|
)
|
|
(161
|
)
|
|
(16)%
|
|
(256
|
)
|
|
(247
|
)
|
|
4%
|
||||
|
Other, net
|
(41
|
)
|
|
(18
|
)
|
|
128%
|
|
(77
|
)
|
|
(22
|
)
|
|
250%
|
||||
|
Total other expense, net
|
$
|
(2,195
|
)
|
|
$
|
(2,021
|
)
|
|
9%
|
|
$
|
(4,415
|
)
|
|
$
|
(6,955
|
)
|
|
(37)%
|
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
|
Six Months Ended
|
|
% Increase / (Decrease)
|
||||||||||||
|
|
June 30,
|
|
|
June 30,
|
|
||||||||||||||
|
|
2014
|
|
2013
|
|
|
2014
|
|
2013
|
|
||||||||||
|
Income tax benefit
|
$
|
—
|
|
|
$
|
—
|
|
|
N/A
|
|
$
|
—
|
|
|
$
|
442
|
|
|
(100)%
|
|
|
Six Months Ended
|
||||||
|
|
June 30,
|
||||||
|
|
2014
|
|
2013
|
||||
|
Net cash provided by (used in):
|
|
|
|
||||
|
Operating activities
|
$
|
3,482
|
|
|
$
|
(27,099
|
)
|
|
Investing activities
|
(21,555
|
)
|
|
(61,774
|
)
|
||
|
Financing activities
|
113,758
|
|
|
87,373
|
|
||
|
Net increase (decrease) in cash and cash equivalents
|
$
|
95,685
|
|
|
$
|
(1,500
|
)
|
|
•
|
our ability to successfully continue our commercialization of EXPAREL;
|
|
•
|
the cost and timing of expanding our manufacturing facilities for EXPAREL and our other product candidates, including costs associated with certain technical transfer activities and construction of two dedicated manufacturing suites in the United Kingdom;
|
|
•
|
the costs of performing additional clinical trials for EXPAREL, including the pediatric trials required by the FDA as a condition of approval, and costs of development for our other product candidates;
|
|
•
|
the extent to which we acquire or invest in products, businesses and technologies; and
|
|
•
|
the extent to which the holders of our Notes elect to convert the Notes.
|
|
Exhibit No.
|
|
Description
|
|
|
|
|
|
10.1
|
|
Strategic Co-Production Agreement dated April 4, 2014, by and between Pacira Pharmaceuticals, Inc. and Patheon UK Limited. *
|
|
|
|
|
|
10.2
†
|
|
Manufacturing and Supply Agreement dated April 4, 2014, by and between Pacira Pharmaceuticals, Inc. and Patheon UK Limited. *
|
|
|
|
|
|
10.3
†
|
|
Technical Transfer and Service Agreement dated April 4, 2014, by and between Pacira Pharmaceuticals, Inc. and Patheon UK Limited. *
|
|
|
|
|
|
10.4
|
|
Amended and Restated 2011 Stock Incentive Plan. (1) ***
|
|
|
|
|
|
10.5
|
|
2014 Employee Stock Purchase Plan. (1) ***
|
|
|
|
|
|
10.6
|
|
Form of Nonstatutory Stock Option Agreement under the Amended and Restated 2011 Stock Incentive Plan. (1) ***
|
|
|
|
|
|
31.1
|
|
Certification of President, Chief Executive Officer and Chairman pursuant to Rule 13a-14(a) and 15d-14(a), as amended.*
|
|
|
|
|
|
31.2
|
|
Certification of Senior Vice President and Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a), as amended.*
|
|
|
|
|
|
32.1
|
|
Certification of President, Chief Executive Officer and Chairman pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**
|
|
|
|
|
|
32.2
|
|
Certification of Senior Vice President and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**
|
|
|
|
|
|
101
|
|
The following materials from the Quarterly Report on Form 10-Q of Pacira Pharmaceuticals, Inc. for the quarter ended June 30, 2014, formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets, (ii) the Consolidated Statements of Operations, (iii) the Consolidated Statements of Comprehensive Loss, (iv) the Consolidated Statement of Stockholders’ Equity, (v) the Consolidated Statements of Cash Flows and (vi) the Condensed Notes to Consolidated Financial Statements.
|
|
|
|
PACIRA PHARMACEUTICALS, INC.
(REGISTRANT)
|
|
|
|
|
|
|
|
|
|
Dated:
|
July 31, 2014
|
/s/ DAVID STACK
|
|
|
|
David Stack
|
|
|
|
President, Chief Executive Officer and Chairman
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
|
|
Dated:
|
July 31, 2014
|
/s/ JAMES SCIBETTA
|
|
|
|
James Scibetta
|
|
|
|
Senior Vice President and Chief Financial Officer
|
|
|
|
(Principal Financial Officer)
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|