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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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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 300
Parsippany, New Jersey, 07054
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(Address and Zip Code of Principal Executive Offices)
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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
x
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Accelerated filer
o
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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.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTER ENDED JUNE 30, 2015
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,
2015 |
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December 31,
2014 |
||||
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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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32,722
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$
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37,520
|
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Restricted cash
|
—
|
|
|
1,509
|
|
||
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Short-term investments
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120,425
|
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119,138
|
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||
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Accounts receivable, net
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24,281
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|
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22,366
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|
||
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Inventories, net
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48,769
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29,263
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|
||
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Prepaid expenses and other current assets
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3,429
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|
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4,461
|
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Total current assets
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229,626
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214,257
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Long-term investments
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17,941
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24,431
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Fixed assets, net
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77,809
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60,632
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Goodwill
|
27,123
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23,761
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Intangibles, net
|
242
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|
|
403
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||
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Other assets
|
2,252
|
|
|
2,588
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||
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Total assets
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$
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354,993
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$
|
326,072
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||||
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LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
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Current liabilities:
|
|
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|
||
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Accounts payable
|
$
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13,299
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$
|
6,758
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Accrued expenses
|
26,790
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|
|
28,311
|
|
||
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Convertible senior notes
|
103,885
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|
|
103,100
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|
||
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Current portion of royalty interest obligation
|
—
|
|
|
276
|
|
||
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Current portion of deferred revenue
|
1,426
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|
|
1,426
|
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||
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Income taxes payable
|
72
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|
|
139
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|
||
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Total current liabilities
|
145,472
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140,010
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Deferred revenue
|
8,795
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|
|
9,508
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||
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Other liabilities
|
5,447
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|
|
5,409
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Total liabilities
|
159,714
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|
154,927
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||
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Commitments and contingencies (Note 12)
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||||
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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, 2015 and December 31, 2014 |
—
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—
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Common stock, par value $0.001, 250,000,000 shares authorized; 36,607,839 shares issued and
outstanding at June 30, 2015; 36,150,620 shares issued and outstanding at December 31, 2014 |
37
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36
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Additional paid-in capital
|
504,146
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481,334
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Accumulated deficit
|
(308,877
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)
|
|
(310,145
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)
|
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Accumulated other comprehensive loss
|
(27
|
)
|
|
(80
|
)
|
||
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Total stockholders’ equity
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195,279
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|
171,145
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|
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Total liabilities and stockholders’ equity
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$
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354,993
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$
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326,072
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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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June 30,
|
|
June 30,
|
||||||||||||
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2015
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2014
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2015
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2014
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||||||||
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Revenues:
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Net product sales
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$
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58,062
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$
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46,034
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$
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115,146
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$
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81,776
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Collaborative licensing and development revenue
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356
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322
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713
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574
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||||
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Royalty revenue
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730
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|
809
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1,604
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1,478
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||||
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Total revenues
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59,148
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47,165
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117,463
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83,828
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Operating expenses:
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Cost of goods sold
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18,929
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19,954
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36,509
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|
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38,081
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|
||||
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Research and development
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3,649
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5,216
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9,616
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|
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10,420
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Selling, general and administrative
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34,752
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24,837
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|
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66,180
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|
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47,426
|
|
||||
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Total operating expenses
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57,330
|
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|
50,007
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112,305
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|
95,927
|
|
||||
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Income (loss) from operations
|
1,818
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(2,842
|
)
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5,158
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|
(12,099
|
)
|
||||
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Other (expense) income:
|
|
|
|
|
|
|
|
|
|
|
|
||||
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Interest income
|
177
|
|
|
61
|
|
|
332
|
|
|
103
|
|
||||
|
Interest expense
|
(1,940
|
)
|
|
(2,079
|
)
|
|
(3,935
|
)
|
|
(4,185
|
)
|
||||
|
Royalty interest obligation
|
—
|
|
|
(136
|
)
|
|
(71
|
)
|
|
(256
|
)
|
||||
|
Loss on extinguishment of debt
|
(51
|
)
|
|
—
|
|
|
(51
|
)
|
|
—
|
|
||||
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Other, net
|
43
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|
|
(41
|
)
|
|
(74
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)
|
|
(77
|
)
|
||||
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Total other expense, net
|
(1,771
|
)
|
|
(2,195
|
)
|
|
(3,799
|
)
|
|
(4,415
|
)
|
||||
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Income (loss) before income taxes
|
47
|
|
|
(5,037
|
)
|
|
1,359
|
|
|
(16,514
|
)
|
||||
|
Income tax expense
|
(39
|
)
|
|
—
|
|
|
(91
|
)
|
|
—
|
|
||||
|
Net income (loss)
|
$
|
8
|
|
|
$
|
(5,037
|
)
|
|
$
|
1,268
|
|
|
$
|
(16,514
|
)
|
|
|
|
|
|
|
|
|
|
||||||||
|
Net income (loss) per share:
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Basic and diluted net income (loss) per common share
|
$
|
0.00
|
|
|
$
|
(0.14
|
)
|
|
$
|
0.03
|
|
|
$
|
(0.48
|
)
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
||||||
|
Basic
|
36,481
|
|
|
35,463
|
|
|
36,358
|
|
|
34,587
|
|
||||
|
Diluted
|
41,445
|
|
|
35,463
|
|
|
41,612
|
|
|
34,587
|
|
||||
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(Unaudited)
(In thousands)
|
|||||||||||||||
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
|
June 30,
|
|
June 30,
|
||||||||||||
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
|
Net income (loss)
|
$
|
8
|
|
|
$
|
(5,037
|
)
|
|
$
|
1,268
|
|
|
$
|
(16,514
|
)
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Net unrealized gain (loss) on investments
|
1
|
|
|
(36
|
)
|
|
53
|
|
|
(36
|
)
|
||||
|
Total other comprehensive income (loss)
|
1
|
|
|
(36
|
)
|
|
53
|
|
|
(36
|
)
|
||||
|
Comprehensive income (loss)
|
$
|
9
|
|
|
$
|
(5,073
|
)
|
|
$
|
1,321
|
|
|
$
|
(16,550
|
)
|
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
FOR THE SIX MONTHS ENDED JUNE 30, 2015
(Unaudited)
(In thousands)
|
||||||||||||||||||||||
|
|
Common Stock
|
|
Additional
Paid-In Capital |
|
Accumulated
Deficit |
|
Accumulated
Other Comprehensive Income (Loss) |
|
|
|||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
|
Total
|
||||||||||||||
|
Balances at December 31, 2014
|
36,151
|
|
|
$
|
36
|
|
|
$
|
481,334
|
|
|
$
|
(310,145
|
)
|
|
$
|
(80
|
)
|
|
$
|
171,145
|
|
|
Exercise of stock options
|
393
|
|
|
1
|
|
|
6,974
|
|
|
—
|
|
|
—
|
|
|
6,975
|
|
|||||
|
Shares issued under employee stock
purchase plan |
20
|
|
|
—
|
|
|
1,195
|
|
|
—
|
|
|
—
|
|
|
1,195
|
|
|||||
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
14,813
|
|
|
—
|
|
|
—
|
|
|
14,813
|
|
|||||
|
Issuance of common stock upon
conversion of convertible senior notes |
44
|
|
|
—
|
|
|
3,930
|
|
|
—
|
|
|
—
|
|
|
3,930
|
|
|||||
|
Retirement of equity component
of convertible senior notes |
—
|
|
|
—
|
|
|
(4,100
|
)
|
|
—
|
|
|
—
|
|
|
(4,100
|
)
|
|||||
|
Net unrealized gain on investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
53
|
|
|
53
|
|
|||||
|
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
1,268
|
|
|
—
|
|
|
1,268
|
|
|||||
|
Balances at June 30, 2015
|
36,608
|
|
|
$
|
37
|
|
|
$
|
504,146
|
|
|
$
|
(308,877
|
)
|
|
$
|
(27
|
)
|
|
$
|
195,279
|
|
|
PACIRA PHARMACEUTICALS, INC.
(Unaudited)
(In thousands)
|
|||||||
|
|
Six Months Ended
|
||||||
|
|
June 30,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Operating activities:
|
|
|
|
|
|
||
|
Net income (loss)
|
$
|
1,268
|
|
|
$
|
(16,514
|
)
|
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
|
|
|
|
|
|
||
|
Depreciation of fixed assets and amortization of intangibles
|
5,526
|
|
|
4,936
|
|
||
|
Amortization of unfavorable lease obligation and debt issuance costs
|
241
|
|
|
243
|
|
||
|
Amortization of debt discount
|
2,058
|
|
|
2,069
|
|
||
|
Loss on extinguishment of debt
|
51
|
|
|
—
|
|
||
|
Loss on disposal of fixed assets
|
—
|
|
|
157
|
|
||
|
Stock-based compensation
|
14,813
|
|
|
9,512
|
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
||
|
Restricted cash
|
1,509
|
|
|
(535
|
)
|
||
|
Accounts receivable, net
|
(1,915
|
)
|
|
(5,955
|
)
|
||
|
Inventories, net
|
(19,506
|
)
|
|
(3,637
|
)
|
||
|
Prepaid expenses and other current assets
|
1,032
|
|
|
(332
|
)
|
||
|
Accounts payable and accrued expenses
|
5,018
|
|
|
5,226
|
|
||
|
Royalty interest obligation
|
(276
|
)
|
|
(377
|
)
|
||
|
Other liabilities
|
38
|
|
|
1,263
|
|
||
|
Deferred revenue
|
(713
|
)
|
|
7,426
|
|
||
|
Net cash provided by operating activities
|
9,144
|
|
|
3,482
|
|
||
|
Investing activities:
|
|
|
|
|
|
||
|
Purchases of fixed assets
|
(22,542
|
)
|
|
(9,831
|
)
|
||
|
Purchases of short-term investments
|
(92,921
|
)
|
|
(52,992
|
)
|
||
|
Sales of short-term investments
|
98,179
|
|
|
56,941
|
|
||
|
Purchases of long-term investments
|
—
|
|
|
(13,481
|
)
|
||
|
Payment of contingent consideration
|
(3,362
|
)
|
|
(2,192
|
)
|
||
|
Net cash used in investing activities
|
(20,646
|
)
|
|
(21,555
|
)
|
||
|
Financing activities:
|
|
|
|
|
|
||
|
Proceeds from follow-on public offering, net
|
—
|
|
|
110,407
|
|
||
|
Proceeds from exercise of stock options and warrants
|
6,975
|
|
|
3,351
|
|
||
|
Proceeds from shares issued under employee stock purchase plan
|
1,195
|
|
|
—
|
|
||
|
Conversion of principal and equity component of convertible senior notes
|
(1,466
|
)
|
|
—
|
|
||
|
Net cash provided by financing activities
|
6,704
|
|
|
113,758
|
|
||
|
Net (decrease) increase in cash and cash equivalents
|
(4,798
|
)
|
|
95,685
|
|
||
|
Cash and cash equivalents, beginning of period
|
37,520
|
|
|
12,515
|
|
||
|
Cash and cash equivalents, end of period
|
$
|
32,722
|
|
|
$
|
108,200
|
|
|
Supplemental cash flow information:
|
|
|
|
|
|
||
|
Cash paid for interest, including royalty interest obligation
|
$
|
2,297
|
|
|
$
|
2,583
|
|
|
Cash paid for income taxes
|
$
|
159
|
|
|
$
|
—
|
|
|
Non-cash investing and financing activities:
|
|
|
|
||||
|
Issuance of stock from conversion of convertible senior notes
|
$
|
3,930
|
|
|
$
|
—
|
|
|
|
Three Months Ended
|
|
Six Months Ended
|
||||
|
|
June 30,
|
|
June 30,
|
||||
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
Largest customer
|
32%
|
|
33%
|
|
31%
|
|
33%
|
|
Second largest customer
|
28%
|
|
29%
|
|
29%
|
|
29%
|
|
Third largest customer
|
27%
|
|
23%
|
|
27%
|
|
23%
|
|
|
87%
|
|
85%
|
|
87%
|
|
85%
|
|
|
June 30,
|
|
December 31,
|
||||
|
|
2015
|
|
2014
|
||||
|
Raw materials
|
$
|
11,198
|
|
|
$
|
9,263
|
|
|
Work-in-process
|
13,853
|
|
|
8,617
|
|
||
|
Finished goods
|
23,718
|
|
|
11,383
|
|
||
|
Total
|
$
|
48,769
|
|
|
$
|
29,263
|
|
|
|
June 30,
|
|
December 31,
|
||||
|
|
2015
|
|
2014
|
||||
|
Machinery and laboratory equipment
|
$
|
30,653
|
|
|
$
|
29,697
|
|
|
Leasehold improvements
|
27,343
|
|
|
26,350
|
|
||
|
Computer equipment and software
|
4,037
|
|
|
3,754
|
|
||
|
Office furniture and equipment
|
1,001
|
|
|
1,001
|
|
||
|
Construction in progress
|
40,254
|
|
|
19,944
|
|
||
|
Total
|
103,288
|
|
|
80,746
|
|
||
|
Less: accumulated depreciation
|
(25,479
|
)
|
|
(20,114
|
)
|
||
|
Fixed assets, net
|
$
|
77,809
|
|
|
$
|
60,632
|
|
|
(i)
|
$10.0 million
upon the first commercial sale in the United States (met April 2012);
|
|
(ii)
|
$4.0 million
upon the 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
(met September 2014);
|
|
(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
.
|
|
|
Carrying Value of Goodwill
|
||
|
Balance at December 31, 2014
|
$
|
23,761
|
|
|
Percentage payments on collections of net sales of EXPAREL
|
3,362
|
|
|
|
Balance at June 30, 2015
|
$
|
27,123
|
|
|
June 30, 2015
|
|
Gross
Carrying Value |
|
Accumulated
Amortization |
|
Intangible
Assets, Net |
|
Estimated
Useful Life |
||||||
|
Amortizable intangible assets:
|
|
|
|
|
|
|
|
|
||||||
|
Core technology
|
|
$
|
2,900
|
|
|
$
|
(2,658
|
)
|
|
$
|
242
|
|
|
9 Years
|
|
Developed technology
|
|
11,700
|
|
|
(11,700
|
)
|
|
—
|
|
|
7 Years
|
|||
|
Trademarks and trade names
|
|
400
|
|
|
(400
|
)
|
|
—
|
|
|
7 Years
|
|||
|
Total intangible assets
|
|
$
|
15,000
|
|
|
$
|
(14,758
|
)
|
|
$
|
242
|
|
|
|
|
December 31, 2014
|
|
Gross
Carrying Value |
|
Accumulated
Amortization |
|
Intangible
Assets, Net |
|
Estimated
Useful Life |
||||||
|
Amortizable intangible assets:
|
|
|
|
|
|
|
|
|
||||||
|
Core technology
|
|
$
|
2,900
|
|
|
$
|
(2,497
|
)
|
|
$
|
403
|
|
|
9 Years
|
|
Developed technology
|
|
11,700
|
|
|
(11,700
|
)
|
|
—
|
|
|
7 Years
|
|||
|
Trademarks and trade names
|
|
400
|
|
|
(400
|
)
|
|
—
|
|
|
7 Years
|
|||
|
Total intangible assets
|
|
$
|
15,000
|
|
|
$
|
(14,597
|
)
|
|
$
|
403
|
|
|
|
|
Year
|
|
Future Amortization Expense
|
||
|
2015 (remaining six months)
|
|
$
|
161
|
|
|
2016
|
|
81
|
|
|
|
Total
|
|
$
|
242
|
|
|
|
June 30,
|
|
December 31,
|
||||
|
|
2015
|
|
2014
|
||||
|
Debt:
|
|
|
|
||||
|
Convertible senior notes
|
$
|
118,534
|
|
|
$
|
120,000
|
|
|
Discount on debt
|
(14,649
|
)
|
|
(16,900
|
)
|
||
|
Total debt, net of debt discount
|
103,885
|
|
|
103,100
|
|
||
|
Royalty interest obligation
|
—
|
|
|
276
|
|
||
|
Total debt and financing obligations
|
$
|
103,885
|
|
|
$
|
103,376
|
|
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
|
June 30,
|
|
June 30,
|
||||||||||||
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
|
Contractual interest expense
|
$
|
963
|
|
|
$
|
975
|
|
|
$
|
1,930
|
|
|
$
|
1,950
|
|
|
Amortization of debt issuance costs
|
153
|
|
|
155
|
|
|
308
|
|
|
310
|
|
||||
|
Amortization of debt discount
|
1,024
|
|
|
1,035
|
|
|
2,058
|
|
|
2,069
|
|
||||
|
Capitalized interest
|
(200
|
)
|
|
(86
|
)
|
|
(361
|
)
|
|
(144
|
)
|
||||
|
Total
|
$
|
1,940
|
|
|
$
|
2,079
|
|
|
$
|
3,935
|
|
|
$
|
4,185
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Effective interest rate on the Notes
|
7.20
|
%
|
|
7.22
|
%
|
|
7.20
|
%
|
|
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.
|
|
Financial Liabilities Carried at Historical Cost
|
|
Carrying Value
|
|
Fair Value Measurements Using
|
||||||||||||
|
June 30, 2015
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|||||||||
|
Convertible senior notes *
|
|
$
|
103,885
|
|
|
$
|
—
|
|
|
$
|
338,415
|
|
|
$
|
—
|
|
|
June 30, 2015
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
(Level 2) |
||||||||
|
Debt securities:
|
|
|
|
|
|
|
|
|
||||||||
|
Short-term:
|
|
|
|
|
|
|
|
|
||||||||
|
Asset-backed securities
|
|
$
|
43,913
|
|
|
$
|
3
|
|
|
$
|
(5
|
)
|
|
$
|
43,911
|
|
|
Commercial paper
|
|
6,239
|
|
|
10
|
|
|
—
|
|
|
6,249
|
|
||||
|
Corporate bonds
|
|
70,292
|
|
|
4
|
|
|
(31
|
)
|
|
70,265
|
|
||||
|
Subtotal
|
|
120,444
|
|
|
17
|
|
|
(36
|
)
|
|
120,425
|
|
||||
|
Long-term:
|
|
|
|
|
|
|
|
|
||||||||
|
Corporate bonds
|
|
17,949
|
|
|
8
|
|
|
(16
|
)
|
|
17,941
|
|
||||
|
Total
|
|
$
|
138,393
|
|
|
$
|
25
|
|
|
$
|
(52
|
)
|
|
$
|
138,366
|
|
|
December 31, 2014
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
(Level 2) |
||||||||
|
Debt securities:
|
|
|
|
|
|
|
|
|
||||||||
|
Short-term:
|
|
|
|
|
|
|
|
|
||||||||
|
Asset-backed securities
|
|
$
|
15,009
|
|
|
$
|
—
|
|
|
$
|
(9
|
)
|
|
$
|
15,000
|
|
|
Commercial paper
|
|
1,747
|
|
|
3
|
|
|
—
|
|
|
1,750
|
|
||||
|
Corporate bonds
|
|
102,430
|
|
|
—
|
|
|
(42
|
)
|
|
102,388
|
|
||||
|
Subtotal
|
|
119,186
|
|
|
3
|
|
|
(51
|
)
|
|
119,138
|
|
||||
|
Long-term:
|
|
|
|
|
|
|
|
|
||||||||
|
Corporate bonds
|
|
24,463
|
|
|
10
|
|
|
(42
|
)
|
|
24,431
|
|
||||
|
Total
|
|
$
|
143,649
|
|
|
$
|
13
|
|
|
$
|
(93
|
)
|
|
$
|
143,569
|
|
|
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
|
|
June 30,
|
|
June 30,
|
||||||||||||
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
|
Cost of goods sold
|
|
$
|
1,586
|
|
|
$
|
641
|
|
|
$
|
2,689
|
|
|
$
|
1,135
|
|
|
Research and development
|
|
561
|
|
|
2,137
|
|
|
2,070
|
|
|
3,714
|
|
||||
|
Selling, general and administrative
|
|
5,149
|
|
|
2,759
|
|
|
10,054
|
|
|
4,663
|
|
||||
|
Total
|
|
$
|
7,296
|
|
|
$
|
5,537
|
|
|
$
|
14,813
|
|
|
$
|
9,512
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Stock-based compensation from:
|
|
|
|
|
|
|
|
|
||||||||
|
Stock options (employee awards)
|
|
$
|
6,739
|
|
|
$
|
3,550
|
|
|
$
|
13,049
|
|
|
$
|
5,960
|
|
|
Stock options (consultant awards)
|
|
(54
|
)
|
|
1,987
|
|
|
942
|
|
|
3,552
|
|
||||
|
Restricted stock units (employee awards)
|
|
369
|
|
|
—
|
|
|
369
|
|
|
—
|
|
||||
|
Employee stock purchase plan
|
|
242
|
|
|
—
|
|
|
453
|
|
|
—
|
|
||||
|
Total
|
|
$
|
7,296
|
|
|
$
|
5,537
|
|
|
$
|
14,813
|
|
|
$
|
9,512
|
|
|
Stock Options
|
|
Number of Shares
|
|
Weighted Average Exercise Price
|
|||
|
Outstanding at December 31, 2014
|
|
4,677,856
|
|
|
$
|
35.78
|
|
|
Granted
|
|
629,806
|
|
|
81.29
|
|
|
|
Exercised
|
|
(393,049
|
)
|
|
17.74
|
|
|
|
Forfeited
|
|
(150,108
|
)
|
|
57.57
|
|
|
|
Outstanding at June 30, 2015
|
|
4,764,505
|
|
|
42.60
|
|
|
|
Restricted Stock Units
|
|
Number of Units
|
|
Weighted Average Grant Date Fair Value
|
|||
|
Unvested at December 31, 2014
|
|
—
|
|
|
$
|
—
|
|
|
Granted
|
|
224,296
|
|
|
79.43
|
|
|
|
Vested
|
|
—
|
|
|
—
|
|
|
|
Forfeited
|
|
(567
|
)
|
|
79.43
|
|
|
|
Unvested at June 30, 2015
|
|
223,729
|
|
|
79.43
|
|
|
|
|
|
Six Months Ended
|
||||||
|
|
|
June 30,
|
||||||
|
|
|
2015
|
|
2014
|
||||
|
Net unrealized gains (losses) from available for sale investments:
|
|
|
|
|
||||
|
Balance at beginning of period
|
|
$
|
(80
|
)
|
|
$
|
5
|
|
|
Other comprehensive income (loss) before reclassifications
|
|
53
|
|
|
(36
|
)
|
||
|
Amounts reclassified from accumulated other comprehensive income (loss)
|
|
—
|
|
|
—
|
|
||
|
Balance at end of period
|
|
$
|
(27
|
)
|
|
$
|
(31
|
)
|
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
June 30,
|
|
June 30,
|
|||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|||||||||
|
Numerator:
|
|
|
|
|
|
|
|
||||||||
|
Net income (loss)
|
$
|
8
|
|
|
$
|
(5,037
|
)
|
|
$
|
1,268
|
|
|
$
|
(16,514
|
)
|
|
Denominator:
|
|
|
|
|
|
|
|
||||||||
|
Weighted average shares of common stock outstanding—basic
|
36,481
|
|
|
35,463
|
|
|
36,358
|
|
|
34,587
|
|
||||
|
Computation of diluted securities:
|
|
|
|
|
|
|
|
||||||||
|
Dilutive effect of stock options
|
1,680
|
|
|
—
|
|
|
1,782
|
|
|
—
|
|
||||
|
Dilutive effect of conversion premium on the Notes
|
3,277
|
|
|
—
|
|
|
3,465
|
|
|
—
|
|
||||
|
Dilutive effect of warrants
|
6
|
|
|
—
|
|
|
6
|
|
|
—
|
|
||||
|
Dilutive effect of employee stock purchase plan
|
1
|
|
|
—
|
|
|
1
|
|
|
—
|
|
||||
|
Weighted average shares of common stock outstanding—diluted
|
41,445
|
|
|
35,463
|
|
|
41,612
|
|
|
34,587
|
|
||||
|
Net income (loss) per share:
|
|
|
|
|
|
|
|
||||||||
|
Basic and diluted net income (loss) per share of common stock
|
$
|
0.00
|
|
|
$
|
(0.14
|
)
|
|
$
|
0.03
|
|
|
$
|
(0.48
|
)
|
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||
|
|
June 30,
|
|
June 30,
|
||||||||
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||
|
Weighted average number of stock options
|
1,738
|
|
|
4,146
|
|
|
1,530
|
|
|
4,006
|
|
|
Conversion premium on the Notes
|
—
|
|
|
3,259
|
|
|
—
|
|
|
3,165
|
|
|
Weighted average number of warrants
|
—
|
|
|
46
|
|
|
—
|
|
|
52
|
|
|
Total
|
1,738
|
|
|
7,451
|
|
|
1,530
|
|
|
7,223
|
|
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
|
June 30,
|
|
June 30,
|
||||||||||||
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
|
Income (loss) before income taxes:
|
|
|
|
|
|
|
|
||||||||
|
Domestic
|
$
|
352
|
|
|
$
|
(5,037
|
)
|
|
$
|
2,238
|
|
|
$
|
(16,514
|
)
|
|
Foreign
|
(305
|
)
|
|
—
|
|
|
(879
|
)
|
|
—
|
|
||||
|
Total income (loss) before income taxes
|
$
|
47
|
|
|
$
|
(5,037
|
)
|
|
$
|
1,359
|
|
|
$
|
(16,514
|
)
|
|
Year
|
|
Aggregate Minimum Payments
|
||
|
2015 (remaining six months)
|
|
$
|
3,381
|
|
|
2016
|
|
7,263
|
|
|
|
2017
|
|
7,459
|
|
|
|
2018
|
|
7,660
|
|
|
|
2019
|
|
7,876
|
|
|
|
2020 through 2028
|
|
11,787
|
|
|
|
Total
|
|
$
|
45,426
|
|
|
•
|
EXPAREL is a liposome injection of bupivacaine, an amide-type local anesthetic indicated for single-dose 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 United States and Europe.
|
|
•
|
Total revenues increased
$12.0 million
, or
25%
, in the three months ended
June 30, 2015
, as compared to the same period in 2014, primarily driven by EXPAREL product sales of
$57.0 million
. Our gross margin improved to
68%
in the three months ended
June 30, 2015
, up from
57%
for the same period in 2014. For the six months ended
June 30, 2015
as compared to
June 30, 2014
, total revenues increased
$33.6 million
, or
40%
, and our gross margin improved to
69%
, up from
54%
. Additionally, we had net income for the third consecutive quarter.
|
|
•
|
In May 2015, we received feedback from the FDA’s Division of Anesthesia, Analgesia, and Addiction Products, or DAAAP, of the Center for Drug Evaluation and Research on an EXPAREL DepoFoam spray manufacturing process. Based on this feedback, we intend to pursue the manufacturing of DepoFoam-based products using the spray process.
|
|
•
|
In March 2015, we received a Complete Response Letter from the FDA following a review of our sNDA for the use of EXPAREL in nerve block to provide postsurgical analgesia, and in May 2015 we completed the end-of-review process with the DAAAP. Based upon FDA guidance that the expected use of EXPAREL will be for a broad spectrum of nerve blocks and not limited to the narrow indication of a single nerve block, we plan to conduct additional Phase 3 studies for upper extremity and lower extremity nerve blocks, and expect to initiate these studies by the end of 2015.
|
|
•
|
In April 2015, we received a subpoena from the U.S. Department of Justice, or DOJ, U.S. Attorney’s Office for the District of New Jersey requiring the production of a broad range of documents pertaining to marketing and promotional practices related to EXPAREL. We are cooperating with the government’s inquiry. We can make no assurances as to the time or resources that will need to be devoted to this inquiry or its final outcome, or the impact, if any, of this inquiry or any proceedings on our business, financial condition, results of operations and cash flows.
|
|
•
|
In September 2014, we received a warning letter from the FDA’s Office of Prescription Drug Promotion, or OPDP, pertaining to certain promotional aspects of EXPAREL, and in February 2015, an agreement was reached with the OPDP on the content and mechanisms for distribution of a Dear Healthcare Provider Letter and a corrective journal advertisement. We received a close-out letter in July 2015. We have communicated to our sales force and through other promotional channels the following points to customers thoroughly and accurately:
|
|
•
|
EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia. FDA approval of EXPAREL was based on pivotal trials conducted in excisional hemorrhoidectomy and bunionectomy surgical models, and thus, the basis for assessment of safety and efficacy is limited to those two procedures.
|
|
•
|
Regarding duration of efficacy in the hemorrhoidectomy trial, EXPAREL demonstrated a significant reduction in pain intensity scores compared to placebo for up to 24 hours. The primary endpoint of the study, cumulative pain scores over the first 72 hours, was statistically superior to placebo, however there was minimal to no difference in pain intensity scores between EXPAREL and placebo from 24 to 72 hours. There was a cumulative decrease in opioid consumption through 72 hours, the clinical benefit of which was not demonstrated.
|
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
|
Six Months Ended
|
|
% Increase / (Decrease)
|
||||||||||||
|
|
June 30,
|
|
|
June 30,
|
|
||||||||||||||
|
|
2015
|
|
2014
|
|
|
2015
|
|
2014
|
|
||||||||||
|
Net product sales:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
EXPAREL
|
$
|
56,977
|
|
|
$
|
44,914
|
|
|
27%
|
|
$
|
112,927
|
|
|
$
|
79,316
|
|
|
42%
|
|
DepoCyt(e)
|
1,085
|
|
|
1,120
|
|
|
(3)%
|
|
2,219
|
|
|
2,460
|
|
|
(10)%
|
||||
|
Total net product sales
|
58,062
|
|
|
46,034
|
|
|
26%
|
|
115,146
|
|
|
81,776
|
|
|
41%
|
||||
|
Collaborative licensing and development revenue
|
356
|
|
|
322
|
|
|
11%
|
|
713
|
|
|
574
|
|
|
24%
|
||||
|
Royalty revenue
|
730
|
|
|
809
|
|
|
(10)%
|
|
1,604
|
|
|
1,478
|
|
|
9%
|
||||
|
Total revenues
|
$
|
59,148
|
|
|
$
|
47,165
|
|
|
25%
|
|
$
|
117,463
|
|
|
$
|
83,828
|
|
|
40%
|
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
|
Six Months Ended
|
|
% Increase / (Decrease)
|
||||||||||||
|
|
June 30,
|
|
|
June 30,
|
|
||||||||||||||
|
|
2015
|
|
2014
|
|
|
2015
|
|
2014
|
|
||||||||||
|
Cost of goods sold
|
$
|
18,929
|
|
|
$
|
19,954
|
|
|
(5)%
|
|
$
|
36,509
|
|
|
$
|
38,081
|
|
|
(4)%
|
|
Gross margin *
|
68
|
%
|
|
57
|
%
|
|
|
|
69
|
%
|
|
54
|
%
|
|
|
||||
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
|
Six Months Ended
|
|
% Increase / (Decrease)
|
||||||||||||
|
|
June 30,
|
|
|
June 30,
|
|
||||||||||||||
|
|
2015
|
|
2014
|
|
|
2015
|
|
2014
|
|
||||||||||
|
Clinical studies
|
$
|
1,205
|
|
|
$
|
1,813
|
|
|
(34)%
|
|
$
|
3,162
|
|
|
$
|
3,589
|
|
|
(12)%
|
|
Product development and other
|
1,883
|
|
|
1,266
|
|
|
49%
|
|
4,384
|
|
|
3,117
|
|
|
41%
|
||||
|
Stock-based compensation
|
561
|
|
|
2,137
|
|
|
(74)%
|
|
2,070
|
|
|
3,714
|
|
|
(44)%
|
||||
|
Total research and development expense
|
$
|
3,649
|
|
|
$
|
5,216
|
|
|
(30)%
|
|
$
|
9,616
|
|
|
$
|
10,420
|
|
|
(8)%
|
|
% of total revenues
|
6
|
%
|
|
11
|
%
|
|
|
|
8
|
%
|
|
12
|
%
|
|
|
||||
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
|
Six Months Ended
|
|
% Increase / (Decrease)
|
||||||||||||
|
|
June 30,
|
|
|
June 30,
|
|
||||||||||||||
|
|
2015
|
|
2014
|
|
|
2015
|
|
2014
|
|
||||||||||
|
Sales and marketing
|
$
|
19,519
|
|
|
$
|
15,681
|
|
|
24%
|
|
$
|
37,526
|
|
|
$
|
29,864
|
|
|
26%
|
|
General and administrative
|
10,084
|
|
|
6,397
|
|
|
58%
|
|
18,600
|
|
|
12,899
|
|
|
44%
|
||||
|
Stock-based compensation
|
5,149
|
|
|
2,759
|
|
|
87%
|
|
10,054
|
|
|
4,663
|
|
|
116%
|
||||
|
Total selling, general and administrative expenses
|
$
|
34,752
|
|
|
$
|
24,837
|
|
|
40%
|
|
$
|
66,180
|
|
|
$
|
47,426
|
|
|
40%
|
|
% of total revenues
|
59
|
%
|
|
53
|
%
|
|
|
|
56
|
%
|
|
57
|
%
|
|
|
||||
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
|
Six Months Ended
|
|
% Increase / (Decrease)
|
||||||||||||
|
|
June 30,
|
|
|
June 30,
|
|
||||||||||||||
|
|
2015
|
|
2014
|
|
|
2015
|
|
2014
|
|
||||||||||
|
Interest income
|
$
|
177
|
|
|
$
|
61
|
|
|
190%
|
|
$
|
332
|
|
|
$
|
103
|
|
|
222%
|
|
Interest expense
|
(1,940
|
)
|
|
(2,079
|
)
|
|
(7)%
|
|
(3,935
|
)
|
|
(4,185
|
)
|
|
(6)%
|
||||
|
Royalty interest obligation
|
—
|
|
|
(136
|
)
|
|
(100)%
|
|
(71
|
)
|
|
(256
|
)
|
|
(72)%
|
||||
|
Loss on extinguishment of debt
|
(51
|
)
|
|
—
|
|
|
N/A
|
|
(51
|
)
|
|
—
|
|
|
N/A
|
||||
|
Other, net
|
43
|
|
|
(41
|
)
|
|
N/A
|
|
(74
|
)
|
|
(77
|
)
|
|
(4)%
|
||||
|
Total other expense, net
|
$
|
(1,771
|
)
|
|
$
|
(2,195
|
)
|
|
(19)%
|
|
$
|
(3,799
|
)
|
|
$
|
(4,415
|
)
|
|
(14)%
|
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
|
Six Months Ended
|
|
% Increase / (Decrease)
|
||||||||||||
|
|
June 30,
|
|
|
June 30,
|
|
||||||||||||||
|
|
2015
|
|
2014
|
|
|
2015
|
|
2014
|
|
||||||||||
|
Income tax expense
|
$
|
(39
|
)
|
|
$
|
—
|
|
|
N/A
|
|
$
|
(91
|
)
|
|
$
|
—
|
|
|
N/A
|
|
Effective tax rate
|
83
|
%
|
|
—
|
|
|
|
|
7
|
%
|
|
—
|
|
|
|
||||
|
|
Six Months Ended
|
||||||
|
|
June 30,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Net cash provided by (used in):
|
|
|
|
||||
|
Operating activities
|
$
|
9,144
|
|
|
$
|
3,482
|
|
|
Investing activities
|
(20,646
|
)
|
|
(21,555
|
)
|
||
|
Financing activities
|
6,704
|
|
|
113,758
|
|
||
|
Net (decrease) increase in cash and cash equivalents
|
$
|
(4,798
|
)
|
|
$
|
95,685
|
|
|
•
|
our ability to successfully continue to expand the 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 the construction of manufacturing suites at Patheon’s Swindon, United Kingdom facility;
|
|
•
|
the timing of and extent to which the holders of our Notes elect to convert the Notes;
|
|
•
|
the cost and timing of potential milestone payments to Skyepharma;
|
|
•
|
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; and
|
|
•
|
the extent to which we acquire or invest in products, businesses and technologies.
|
|
June 30, 2015
|
|
Returns Allowances
|
|
Prompt Pay Discounts
|
|
Wholesaler Service Fees
|
|
Volume
Rebates and Chargebacks |
|
Total
|
||||||||||
|
Balance at December 31, 2014
|
|
$
|
1,559
|
|
|
$
|
575
|
|
|
$
|
588
|
|
|
$
|
321
|
|
|
$
|
3,043
|
|
|
Provision
|
|
178
|
|
|
2,306
|
|
|
1,665
|
|
|
695
|
|
|
4,844
|
|
|||||
|
Payments/Credits
|
|
(43
|
)
|
|
(2,307
|
)
|
|
(1,676
|
)
|
|
(666
|
)
|
|
(4,692
|
)
|
|||||
|
Balance at June 30, 2015
|
|
$
|
1,694
|
|
|
$
|
574
|
|
|
$
|
577
|
|
|
$
|
350
|
|
|
$
|
3,195
|
|
|
June 30, 2014
|
|
Returns Allowances
|
|
Prompt Pay Discounts
|
|
Wholesaler Service Fees
|
|
Volume
Rebates and Chargebacks |
|
Total
|
||||||||||
|
Balance at December 31, 2013
|
|
$
|
897
|
|
|
$
|
313
|
|
|
$
|
266
|
|
|
$
|
402
|
|
|
$
|
1,878
|
|
|
Provision
|
|
416
|
|
|
1,626
|
|
|
1,152
|
|
|
761
|
|
|
3,955
|
|
|||||
|
Payments/Credits
|
|
(135
|
)
|
|
(1,496
|
)
|
|
(1,044
|
)
|
|
(198
|
)
|
|
(2,873
|
)
|
|||||
|
Balance at June 30, 2014
|
|
$
|
1,178
|
|
|
$
|
443
|
|
|
$
|
374
|
|
|
$
|
965
|
|
|
$
|
2,960
|
|
|
Exhibit No.
|
|
Description
|
|
|
|
|
|
10.1
†
|
|
Third Amendment to Commercial Outsourcing Services Agreement, dated April 29, 2015 and effective as of December 1, 2014, between Pacira Pharmaceuticals, Inc. and Integrated Commercialization Solutions, Inc.*
|
|
|
|
|
|
10.2
+
|
|
Amendment No. 2 to Executive Employment Agreement, dated June 30, 2015, between Pacira Pharmaceuticals, Inc. and David Stack.*
|
|
|
|
|
|
10.3
+
|
|
Amendment No. 2 to Executive Employment Agreement, dated June 30, 2015, between Pacira Pharmaceuticals, Inc. and James Scibetta.*
|
|
|
|
|
|
10.4
+
|
|
Amendment No. 2 to Executive Employment Agreement, dated June 30, 2015, between Pacira Pharmaceuticals, Inc. and Taunia Markvicka.*
|
|
|
|
|
|
10.5
+
|
|
Amendment No. 2 to Employment Agreement, dated June 30, 2015, between Pacira Pharmaceuticals, Inc. and Kristen Williams.*
|
|
|
|
|
|
10.6
+
|
|
Form of Restricted Stock Unit Award Agreement (Employees) under the Amended and Restated 2011 Stock Incentive Plan.*
|
|
|
|
|
|
10.7
+
|
|
Form of Restricted Stock Unit Award Agreement (Non-Employee Directors) under the Amended and Restated 2011 Stock Incentive Plan.*
|
|
|
|
|
|
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, Chief Financial Officer and Head of Technical Operations 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, Chief Financial Officer and Head of Technical Operations 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, 2015, formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets; (ii) the Consolidated Statements of Operations; (iii) the Consolidated Statements of Comprehensive Income (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 30, 2015
|
/s/ DAVID STACK
|
|
|
|
David Stack
|
|
|
|
President, Chief Executive Officer and Chairman
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
|
|
Dated:
|
July 30, 2015
|
/s/ JAMES SCIBETTA
|
|
|
|
James Scibetta
|
|
|
|
Senior Vice President, Chief Financial Officer
and Head of Technical Operations
|
|
|
|
(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 |
|---|
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