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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 SEPTEMBER 30, 2016
TABLE OF CONTENTS
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Page #
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||
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PACIRA PHARMACEUTICALS, INC.
(In thousands, except share and per share amounts)
(Unaudited)
|
|||||||
|
|
September 30,
2016 |
|
December 31,
2015 |
||||
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(Note 2)
|
||||
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ASSETS
|
|
|
|
|
|
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Current assets:
|
|
|
|
|
|
||
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Cash and cash equivalents
|
$
|
24,442
|
|
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$
|
56,984
|
|
|
Short-term investments
|
136,686
|
|
|
101,981
|
|
||
|
Accounts receivable, net
|
26,765
|
|
|
25,855
|
|
||
|
Inventories, net
|
37,476
|
|
|
61,645
|
|
||
|
Prepaid expenses and other current assets
|
10,075
|
|
|
6,117
|
|
||
|
Total current assets
|
235,444
|
|
|
252,582
|
|
||
|
Long-term investments
|
—
|
|
|
13,462
|
|
||
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Fixed assets, net
|
100,388
|
|
|
90,324
|
|
||
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Goodwill
|
44,670
|
|
|
30,880
|
|
||
|
Intangible assets, net
|
—
|
|
|
81
|
|
||
|
Other assets
|
651
|
|
|
406
|
|
||
|
Total assets
|
$
|
381,153
|
|
|
$
|
387,735
|
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|
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||||
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
||
|
Current liabilities:
|
|
|
|
|
|
||
|
Accounts payable
|
$
|
7,287
|
|
|
$
|
8,739
|
|
|
Accrued expenses
|
31,077
|
|
|
35,375
|
|
||
|
Convertible senior notes
|
107,563
|
|
|
104,040
|
|
||
|
Current portion of deferred revenue
|
822
|
|
|
1,426
|
|
||
|
Income taxes payable
|
82
|
|
|
208
|
|
||
|
Total current liabilities
|
146,831
|
|
|
149,788
|
|
||
|
Deferred revenue
|
7,617
|
|
|
8,082
|
|
||
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Other liabilities
|
12,557
|
|
|
11,473
|
|
||
|
Total liabilities
|
167,005
|
|
|
169,343
|
|
||
|
Commitments and contingencies (Note 12)
|
|
|
|
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|
||
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Stockholders’ equity:
|
|
|
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|
|
||
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Preferred stock, par value $0.001; 5,000,000 shares authorized; none issued and outstanding at
September 30, 2016 and December 31, 2015 |
—
|
|
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—
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|
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Common stock, par value $0.001, 250,000,000 shares authorized; 37,368,592 shares issued and
outstanding at September 30, 2016; 36,848,319 shares issued and outstanding at December 31, 2015 |
37
|
|
|
37
|
|
||
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Additional paid-in capital
|
556,405
|
|
|
526,696
|
|
||
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Accumulated deficit
|
(342,266
|
)
|
|
(308,289
|
)
|
||
|
Accumulated other comprehensive loss
|
(28
|
)
|
|
(52
|
)
|
||
|
Total stockholders’ equity
|
214,148
|
|
|
218,392
|
|
||
|
Total liabilities and stockholders’ equity
|
$
|
381,153
|
|
|
$
|
387,735
|
|
|
PACIRA PHARMACEUTICALS, INC.
(In thousands, except per share amounts)
(Unaudited)
|
|||||||||||||||
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Revenues:
|
|
|
|
|
|
|
|
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||||
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Net product sales
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$
|
66,119
|
|
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$
|
61,150
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|
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$
|
198,309
|
|
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$
|
176,297
|
|
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Collaborative licensing and milestone revenue
|
1,357
|
|
|
357
|
|
|
3,069
|
|
|
1,069
|
|
||||
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Royalty revenue
|
879
|
|
|
706
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|
|
2,091
|
|
|
2,310
|
|
||||
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Total revenues
|
68,355
|
|
|
62,213
|
|
|
203,469
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|
|
179,676
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|
||||
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Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
||||
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Cost of goods sold
|
43,152
|
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|
15,901
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|
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86,483
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|
|
52,409
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|
||||
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Research and development
|
9,754
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|
|
5,893
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|
|
28,609
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|
|
15,509
|
|
||||
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Selling, general and administrative
|
36,314
|
|
|
35,310
|
|
|
117,940
|
|
|
101,490
|
|
||||
|
Total operating expenses
|
89,220
|
|
|
57,104
|
|
|
233,032
|
|
|
169,408
|
|
||||
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Income (loss) from operations
|
(20,865
|
)
|
|
5,109
|
|
|
(29,563
|
)
|
|
10,268
|
|
||||
|
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Interest income
|
346
|
|
|
171
|
|
|
923
|
|
|
504
|
|
||||
|
Interest expense
|
(1,601
|
)
|
|
(1,905
|
)
|
|
(5,203
|
)
|
|
(5,842
|
)
|
||||
|
Royalty interest obligation
|
—
|
|
|
—
|
|
|
—
|
|
|
(71
|
)
|
||||
|
Loss on early extinguishment of debt
|
—
|
|
|
—
|
|
|
—
|
|
|
(51
|
)
|
||||
|
Other, net
|
(8
|
)
|
|
(8
|
)
|
|
(8
|
)
|
|
(82
|
)
|
||||
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Total other expense, net
|
(1,263
|
)
|
|
(1,742
|
)
|
|
(4,288
|
)
|
|
(5,542
|
)
|
||||
|
Income (loss) before income taxes
|
(22,128
|
)
|
|
3,367
|
|
|
(33,851
|
)
|
|
4,726
|
|
||||
|
Income tax expense
|
(36
|
)
|
|
(281
|
)
|
|
(126
|
)
|
|
(372
|
)
|
||||
|
Net income (loss)
|
$
|
(22,164
|
)
|
|
$
|
3,086
|
|
|
$
|
(33,977
|
)
|
|
$
|
4,354
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Net income (loss) per share:
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Basic net income (loss) per common share
|
$
|
(0.59
|
)
|
|
$
|
0.08
|
|
|
$
|
(0.91
|
)
|
|
$
|
0.12
|
|
|
Diluted net income (loss) per common share
|
$
|
(0.59
|
)
|
|
$
|
0.08
|
|
|
$
|
(0.91
|
)
|
|
$
|
0.11
|
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
||||||
|
Basic
|
37,312
|
|
|
36,663
|
|
|
37,171
|
|
|
36,460
|
|
||||
|
Diluted
|
37,312
|
|
|
41,043
|
|
|
37,171
|
|
|
41,422
|
|
||||
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(In thousands)
(Unaudited)
|
|||||||||||||||
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Net income (loss)
|
$
|
(22,164
|
)
|
|
$
|
3,086
|
|
|
$
|
(33,977
|
)
|
|
$
|
4,354
|
|
|
Other comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Net unrealized gain (loss) on investments
|
(166
|
)
|
|
(2
|
)
|
|
24
|
|
|
51
|
|
||||
|
Total other comprehensive income (loss)
|
(166
|
)
|
|
(2
|
)
|
|
24
|
|
|
51
|
|
||||
|
Comprehensive income (loss)
|
$
|
(22,330
|
)
|
|
$
|
3,084
|
|
|
$
|
(33,953
|
)
|
|
$
|
4,405
|
|
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2016
(In thousands)
(Unaudited)
|
||||||||||||||||||||||
|
|
Common Stock
|
|
Additional
Paid-In Capital |
|
Accumulated
Deficit |
|
Accumulated
Other Comprehensive Income (Loss) |
|
|
|||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
|
Total
|
||||||||||||||
|
Balances at December 31, 2015
|
36,848
|
|
|
$
|
37
|
|
|
$
|
526,696
|
|
|
$
|
(308,289
|
)
|
|
$
|
(52
|
)
|
|
$
|
218,392
|
|
|
Exercise of stock options
|
425
|
|
|
—
|
|
|
5,200
|
|
|
—
|
|
|
—
|
|
|
5,200
|
|
|||||
|
Vested restricted stock units
|
61
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
|
Shares issued under employee stock
purchase plan |
35
|
|
|
—
|
|
|
995
|
|
|
—
|
|
|
—
|
|
|
995
|
|
|||||
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
23,516
|
|
|
—
|
|
|
—
|
|
|
23,516
|
|
|||||
|
Retirement of equity component
of convertible senior notes |
—
|
|
|
—
|
|
|
(2
|
)
|
|
—
|
|
|
—
|
|
|
(2
|
)
|
|||||
|
Net unrealized gain on investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
24
|
|
|
24
|
|
|||||
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(33,977
|
)
|
|
—
|
|
|
(33,977
|
)
|
|||||
|
Balances at September 30, 2016
|
37,369
|
|
|
$
|
37
|
|
|
$
|
556,405
|
|
|
$
|
(342,266
|
)
|
|
$
|
(28
|
)
|
|
$
|
214,148
|
|
|
PACIRA PHARMACEUTICALS, INC.
(In thousands)
(Unaudited)
|
|||||||
|
|
Nine Months Ended
September 30, |
||||||
|
|
2016
|
|
2015
|
||||
|
|
|
|
(Note 2)
|
||||
|
Operating activities:
|
|
|
|
|
|
||
|
Net income (loss)
|
$
|
(33,977
|
)
|
|
$
|
4,354
|
|
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
|
|
|
|
|
|
||
|
Depreciation of fixed assets and amortization of intangibles
|
9,659
|
|
|
8,356
|
|
||
|
Amortization of unfavorable lease obligation and debt issuance costs, net
|
359
|
|
|
361
|
|
||
|
Amortization of debt discount
|
3,066
|
|
|
3,080
|
|
||
|
Loss on early extinguishment of debt
|
—
|
|
|
51
|
|
||
|
Stock-based compensation
|
23,516
|
|
|
23,640
|
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
||
|
Restricted cash
|
—
|
|
|
1,509
|
|
||
|
Accounts receivable, net
|
(910
|
)
|
|
(3,553
|
)
|
||
|
Inventories, net
|
24,169
|
|
|
(26,869
|
)
|
||
|
Prepaid expenses and other assets
|
(4,202
|
)
|
|
(647
|
)
|
||
|
Accounts payable, accrued expenses and income taxes payable
|
(5,691
|
)
|
|
1,100
|
|
||
|
Royalty interest obligation
|
—
|
|
|
(276
|
)
|
||
|
Other liabilities
|
1,184
|
|
|
990
|
|
||
|
Deferred revenue
|
(1,069
|
)
|
|
(1,069
|
)
|
||
|
Net cash provided by operating activities
|
16,104
|
|
|
11,027
|
|
||
|
Investing activities:
|
|
|
|
|
|
||
|
Purchases of fixed assets
|
(19,827
|
)
|
|
(31,212
|
)
|
||
|
Purchases of investments
|
(158,390
|
)
|
|
(125,197
|
)
|
||
|
Sales of investments
|
137,170
|
|
|
134,984
|
|
||
|
Payment of contingent consideration
|
(13,790
|
)
|
|
(5,127
|
)
|
||
|
Net cash used in investing activities
|
(54,837
|
)
|
|
(26,552
|
)
|
||
|
Financing activities:
|
|
|
|
|
|
||
|
Proceeds from exercise of stock options
|
5,200
|
|
|
8,798
|
|
||
|
Proceeds from shares issued under employee stock purchase plan
|
995
|
|
|
1,195
|
|
||
|
Conversion of principal and premium paid on convertible senior notes
|
(4
|
)
|
|
(1,466
|
)
|
||
|
Net cash provided by financing activities
|
6,191
|
|
|
8,527
|
|
||
|
Net decrease in cash and cash equivalents
|
(32,542
|
)
|
|
(6,998
|
)
|
||
|
Cash and cash equivalents, beginning of period
|
56,984
|
|
|
37,520
|
|
||
|
Cash and cash equivalents, end of period
|
$
|
24,442
|
|
|
$
|
30,522
|
|
|
Supplemental cash flow information:
|
|
|
|
|
|
||
|
Cash paid for interest, including royalty interest obligation
|
$
|
3,852
|
|
|
$
|
4,224
|
|
|
Cash paid for income taxes, net of refunds
|
$
|
253
|
|
|
$
|
199
|
|
|
Non-cash investing and financing activities:
|
|
|
|
||||
|
Issuance of stock from conversion of convertible senior notes
|
$
|
—
|
|
|
$
|
3,930
|
|
|
Net increase (decrease) in accrued fixed assets
|
$
|
(185
|
)
|
|
$
|
2,595
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
Largest customer
|
31%
|
|
33%
|
|
32%
|
|
32%
|
|
Second largest customer
|
27%
|
|
29%
|
|
27%
|
|
30%
|
|
Third largest customer
|
27%
|
|
27%
|
|
27%
|
|
28%
|
|
|
85%
|
|
89%
|
|
86%
|
|
90%
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2016
|
|
2015
|
||||
|
Raw materials
|
$
|
13,291
|
|
|
$
|
16,712
|
|
|
Work-in-process
|
11,441
|
|
|
12,152
|
|
||
|
Finished goods
|
12,744
|
|
|
32,781
|
|
||
|
Total
|
$
|
37,476
|
|
|
$
|
61,645
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2016
|
|
2015
|
||||
|
Machinery and laboratory equipment
|
$
|
32,920
|
|
|
$
|
29,864
|
|
|
Leasehold improvements
|
32,665
|
|
|
30,834
|
|
||
|
Computer equipment and software
|
5,787
|
|
|
4,007
|
|
||
|
Office furniture and equipment
|
1,606
|
|
|
1,439
|
|
||
|
Construction in progress
|
61,898
|
|
|
49,097
|
|
||
|
Total
|
134,876
|
|
|
115,241
|
|
||
|
Less: accumulated depreciation
|
(34,488
|
)
|
|
(24,917
|
)
|
||
|
Fixed assets, net
|
$
|
100,388
|
|
|
$
|
90,324
|
|
|
(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 E.U. 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
(met June 2016); and
|
|
(v)
|
$32.0 million
when annual net sales collected reach
$500.0 million
.
|
|
|
Carrying Value
|
||
|
Balance at December 31, 2015
|
$
|
30,880
|
|
|
Milestone payments triggered by collections of net sales of DepoBupivacaine products
|
8,000
|
|
|
|
Percentage payments on collections of net sales of DepoBupivacaine products
|
5,790
|
|
|
|
Balance at September 30, 2016
|
$
|
44,670
|
|
|
|
September 30, 2016
|
|
December 31, 2015
|
|
|
||||||||||||||||||||
|
Amortizable Intangible Assets:
|
Gross
Carrying Value |
|
Accumulated
Amortization |
|
Intangible
Assets, Net |
|
Gross
Carrying
Value
|
|
Accumulated
Amortization
|
|
Intangible
Assets, Net
|
|
Estimated
Useful Life |
||||||||||||
|
Core technology
|
$
|
2,900
|
|
|
$
|
(2,900
|
)
|
|
$
|
—
|
|
|
$
|
2,900
|
|
|
$
|
(2,819
|
)
|
|
$
|
81
|
|
|
9 Years
|
|
Developed technology
|
11,700
|
|
|
(11,700
|
)
|
|
—
|
|
|
11,700
|
|
|
(11,700
|
)
|
|
—
|
|
|
7 Years
|
||||||
|
Trademarks and trade names
|
400
|
|
|
(400
|
)
|
|
—
|
|
|
400
|
|
|
(400
|
)
|
|
—
|
|
|
7 Years
|
||||||
|
Total intangible assets
|
$
|
15,000
|
|
|
$
|
(15,000
|
)
|
|
$
|
—
|
|
|
$
|
15,000
|
|
|
$
|
(14,919
|
)
|
|
$
|
81
|
|
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2016
|
|
2015
|
||||
|
3.25% convertible senior notes
|
$
|
118,531
|
|
|
$
|
118,533
|
|
|
Deferred financing costs
|
(1,429
|
)
|
|
(1,888
|
)
|
||
|
Discount on debt
|
(9,539
|
)
|
|
(12,605
|
)
|
||
|
Total debt, net of debt discount
|
$
|
107,563
|
|
|
$
|
104,040
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Contractual interest expense
|
$
|
963
|
|
|
$
|
963
|
|
|
$
|
2,890
|
|
|
$
|
2,893
|
|
|
Amortization of debt issuance costs
|
153
|
|
|
153
|
|
|
459
|
|
|
461
|
|
||||
|
Amortization of debt discount
|
1,022
|
|
|
1,022
|
|
|
3,066
|
|
|
3,080
|
|
||||
|
Capitalized interest (Note 4)
|
(537
|
)
|
|
(233
|
)
|
|
(1,212
|
)
|
|
(592
|
)
|
||||
|
Total
|
$
|
1,601
|
|
|
$
|
1,905
|
|
|
$
|
5,203
|
|
|
$
|
5,842
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Effective interest rate on the Notes
|
7.22
|
%
|
|
7.22
|
%
|
|
7.22
|
%
|
|
7.20
|
%
|
||||
|
•
|
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
|
||||||||||||
|
September 30, 2016
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|||||||||
|
3.25% convertible senior notes *
|
|
$
|
107,563
|
|
|
$
|
—
|
|
|
$
|
179,426
|
|
|
$
|
—
|
|
|
September 30, 2016 Debt Securities
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
(Level 2) |
||||||||
|
Short-term:
|
|
|
|
|
|
|
|
|
||||||||
|
Asset-backed securities
|
|
$
|
20,314
|
|
|
$
|
1
|
|
|
$
|
—
|
|
|
$
|
20,315
|
|
|
Commercial paper
|
|
48,441
|
|
|
13
|
|
|
(15
|
)
|
|
48,439
|
|
||||
|
Corporate bonds
|
|
67,959
|
|
|
4
|
|
|
(31
|
)
|
|
67,932
|
|
||||
|
Total
|
|
$
|
136,714
|
|
|
$
|
18
|
|
|
$
|
(46
|
)
|
|
$
|
136,686
|
|
|
December 31, 2015 Debt Securities
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
(Level 2) |
||||||||
|
Short-term:
|
|
|
|
|
|
|
|
|
||||||||
|
Asset-backed securities
|
|
$
|
27,484
|
|
|
$
|
—
|
|
|
$
|
(15
|
)
|
|
$
|
27,469
|
|
|
Commercial paper
|
|
35,191
|
|
|
31
|
|
|
—
|
|
|
35,222
|
|
||||
|
Corporate bonds
|
|
39,319
|
|
|
2
|
|
|
(31
|
)
|
|
39,290
|
|
||||
|
Subtotal
|
|
101,994
|
|
|
33
|
|
|
(46
|
)
|
|
101,981
|
|
||||
|
Long-term:
|
|
|
|
|
|
|
|
|
||||||||
|
Corporate bonds
|
|
13,501
|
|
|
—
|
|
|
(39
|
)
|
|
13,462
|
|
||||
|
Total
|
|
$
|
115,495
|
|
|
$
|
33
|
|
|
$
|
(85
|
)
|
|
$
|
115,443
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Cost of goods sold
|
|
$
|
1,627
|
|
|
$
|
1,690
|
|
|
$
|
4,786
|
|
|
$
|
4,379
|
|
|
Research and development
|
|
690
|
|
|
1,070
|
|
|
2,598
|
|
|
3,140
|
|
||||
|
Selling, general and administrative
|
|
5,044
|
|
|
6,066
|
|
|
16,132
|
|
|
16,121
|
|
||||
|
Total
|
|
$
|
7,361
|
|
|
$
|
8,826
|
|
|
$
|
23,516
|
|
|
$
|
23,640
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Stock-based compensation from:
|
|
|
|
|
|
|
|
|
||||||||
|
Stock options (employee awards)
|
|
$
|
5,684
|
|
|
$
|
6,991
|
|
|
$
|
18,318
|
|
|
$
|
19,926
|
|
|
Stock options (consultant awards)
|
|
150
|
|
|
402
|
|
|
872
|
|
|
1,459
|
|
||||
|
Restricted stock units (employee awards)
|
|
1,425
|
|
|
1,257
|
|
|
3,650
|
|
|
1,626
|
|
||||
|
Employee stock purchase plan
|
|
102
|
|
|
176
|
|
|
676
|
|
|
629
|
|
||||
|
Total
|
|
$
|
7,361
|
|
|
$
|
8,826
|
|
|
$
|
23,516
|
|
|
$
|
23,640
|
|
|
Stock Options
|
|
Number of Options
|
|
Weighted Average Exercise Price
|
|||
|
Outstanding at December 31, 2015
|
|
4,645,722
|
|
|
$
|
44.03
|
|
|
Granted
|
|
830,728
|
|
|
43.87
|
|
|
|
Exercised
|
|
(424,519
|
)
|
|
12.25
|
|
|
|
Forfeited
|
|
(350,438
|
)
|
|
71.05
|
|
|
|
Expired
|
|
(141,000
|
)
|
|
81.50
|
|
|
|
Outstanding at September 30, 2016
|
|
4,560,493
|
|
|
43.70
|
|
|
|
Restricted Stock Units
|
|
Number of Units
|
|
Weighted Average Grant Date Fair Value
|
|||
|
Unvested at December 31, 2015
|
|
216,198
|
|
|
$
|
78.59
|
|
|
Granted
|
|
248,381
|
|
|
40.43
|
|
|
|
Vested
|
|
(61,049
|
)
|
|
78.60
|
|
|
|
Forfeited
|
|
(38,608
|
)
|
|
72.10
|
|
|
|
Unvested at September 30, 2016
|
|
364,922
|
|
|
53.23
|
|
|
|
|
Nine Months Ended
September 30, |
||
|
|
2016
|
|
2015
|
|
Expected dividend yield
|
None
|
|
None
|
|
Risk free interest rate
|
1.03% - 1.85%
|
|
1.40% - 1.87%
|
|
Expected volatility
|
53.06%
|
|
53.04%
|
|
Expected term of options
|
5.80 years
|
|
5.75 years
|
|
|
|
Nine Months Ended
September 30, |
||||||
|
Net unrealized gains (losses) from available for sale investments:
|
|
2016
|
|
2015
|
||||
|
Balance at beginning of period
|
|
$
|
(52
|
)
|
|
$
|
(80
|
)
|
|
Other comprehensive income before reclassifications
|
|
24
|
|
|
51
|
|
||
|
Amounts reclassified from accumulated other comprehensive income (loss)
|
|
—
|
|
|
—
|
|
||
|
Balance at end of period
|
|
$
|
(28
|
)
|
|
$
|
(29
|
)
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|||||||||
|
Numerator:
|
|
|
|
|
|
|
|
||||||||
|
Net income (loss)
|
$
|
(22,164
|
)
|
|
$
|
3,086
|
|
|
$
|
(33,977
|
)
|
|
$
|
4,354
|
|
|
Denominator:
|
|
|
|
|
|
|
|
||||||||
|
Weighted average common shares outstanding—basic
|
37,312
|
|
|
36,663
|
|
|
37,171
|
|
|
36,460
|
|
||||
|
Computation of diluted securities:
|
|
|
|
|
|
|
|
||||||||
|
Dilutive effect of stock options
|
—
|
|
|
1,530
|
|
|
—
|
|
|
1,698
|
|
||||
|
Dilutive effect of RSUs
|
—
|
|
|
3
|
|
|
—
|
|
|
1
|
|
||||
|
Dilutive effect of conversion premium on the Notes
|
—
|
|
|
2,841
|
|
|
—
|
|
|
3,256
|
|
||||
|
Dilutive effect of warrants
|
—
|
|
|
6
|
|
|
—
|
|
|
6
|
|
||||
|
Dilutive effect of ESPP
|
—
|
|
|
—
|
|
|
—
|
|
|
1
|
|
||||
|
Weighted average common shares outstanding—diluted
|
37,312
|
|
|
41,043
|
|
|
37,171
|
|
|
41,422
|
|
||||
|
Net income (loss) per share:
|
|
|
|
|
|
|
|
||||||||
|
Basic net income (loss) per common share
|
$
|
(0.59
|
)
|
|
$
|
0.08
|
|
|
$
|
(0.91
|
)
|
|
$
|
0.12
|
|
|
Diluted net income (loss) per common share
|
$
|
(0.59
|
)
|
|
$
|
0.08
|
|
|
$
|
(0.91
|
)
|
|
$
|
0.11
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||
|
Weighted average number of stock options
|
4,632
|
|
|
2,235
|
|
|
4,403
|
|
|
1,765
|
|
|
Weighted average number of RSUs
|
372
|
|
|
203
|
|
|
265
|
|
|
68
|
|
|
Conversion premium on the Notes
|
1,750
|
|
|
—
|
|
|
2,288
|
|
|
—
|
|
|
Weighted average number of warrants
|
—
|
|
|
—
|
|
|
1
|
|
|
—
|
|
|
Weighted average ESPP purchase options
|
20
|
|
|
16
|
|
|
22
|
|
|
5
|
|
|
Total
|
6,774
|
|
|
2,454
|
|
|
6,979
|
|
|
1,838
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Income (loss) before income taxes:
|
|
|
|
|
|
|
|
||||||||
|
Domestic
|
$
|
(21,780
|
)
|
|
$
|
3,776
|
|
|
$
|
(32,806
|
)
|
|
$
|
6,014
|
|
|
Foreign
|
(348
|
)
|
|
(409
|
)
|
|
(1,045
|
)
|
|
(1,288
|
)
|
||||
|
Total income (loss) before income taxes
|
$
|
(22,128
|
)
|
|
$
|
3,367
|
|
|
$
|
(33,851
|
)
|
|
$
|
4,726
|
|
|
Year
|
|
Aggregate Minimum Payments
|
||
|
2016 (remaining three months)
|
|
$
|
1,945
|
|
|
2017
|
|
7,878
|
|
|
|
2018
|
|
8,081
|
|
|
|
2019
|
|
8,303
|
|
|
|
2020
|
|
6,420
|
|
|
|
2021 through 2028
|
|
8,731
|
|
|
|
Total
|
|
$
|
41,358
|
|
|
•
|
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, which 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
$6.1 million
, or
10%
, in the three months ended
September 30, 2016
, compared to the same period in 2015, primarily driven by EXPAREL net product sales of
$64.9 million
, which were up
$5.1 million
, or
9%
. For the
nine
months ended
September 30, 2016
, total revenues increased
$23.8 million
, or
13%
compared to the same period in 2015, again driven by EXPAREL net product sales of
$194.4 million
, up
$21.7 million
, or
13%
.
|
|
•
|
As part of our routine stability monitoring that occurred in October 2016, it came to our attention that one of two test batches of EXPAREL made in early 2016 had slightly fallen out of specification for one of the 21 acceptance criteria measured during testing. The other stability test batch remains fully within specifications. The value for this out-of-specification attribute is just 1% outside the target range. All other test attributes, many of which are the key measurements that we believe are the most indicative of the product’s performance and demonstrative of product quality, are within specification and trending according to shelf life expectations. This test result was unexpected and suggestive of some deviation from a consistency of manufacturing output. An internal investigation has tied the unexpected result to a modification to the manufacturing process that existed when this product was made, which has subsequently been corrected. The Company has reserved all impacted inventory on hand as of September 30, 2016, and will initiate communications with the FDA regarding a potential product exchange of a limited number of boxes, that were sold from the impacted inventory. As a result, in the third quarter of 2016, the Company recorded a $21.9 million charge to cost of goods sold related to this matter, of which $20.7 million has been recorded as an inventory reserve and $1.2 million has been recorded within accrued expenses for an estimated number of replacement boxes and other related costs.
|
|
•
|
In September 2016, we officially launched EXPAREL to the oral and maxillofacial market by introducing a 10mL vial for use in patients undergoing third molar (wisdom teeth) extractions. We believe the 10mL vial will also be popular among plastic surgeons. We introduced these 10mL vials in a 10-pack and a 4-pack so that oral surgeons and doctors at smaller surgical centers will have easier access to provide EXPAREL to their patients.
|
|
•
|
In June 2016, we enrolled the first patients in both of our EXPAREL Phase 3 studies for upper and lower extremity nerve blocks, specifically a femoral nerve block for patients undergoing total knee arthroplasty, or TKA, and a brachial plexus nerve block for patients undergoing either total shoulder arthroplasty or rotator cuff repairs. We expect to complete enrollment for both of these trials by early 2017.
|
|
•
|
In June 2016, we recorded an $8.0 million milestone payable to SkyePharma Holding, Inc., or Skyepharma, in connection with achieving $250.0 million of EXPAREL net sales collected on an annual basis.
|
|
•
|
In June 2016, we provided notice to CrossLink BioScience LLC, or CrossLink, of our election to terminate our Master Distributor Agreement for the promotion and sale of EXPAREL effective as of September 30, 2016. A $7.1 million termination fee based on a percentage of earned performance-based fees is due to CrossLink quarterly over two years, beginning in the fourth quarter of 2016.
|
|
•
|
In April 2016, we enrolled the first patient in our EXPAREL infiltration TKA randomized controlled trial, or RCT. With this study we expect to demonstrate the benefits of EXPAREL in treating pain and reducing opioid consumption after post operative day one against bupivacaine, the active comparator. We expect to complete enrollment for this trial by early 2017.
|
|
|
Three Months Ended
September 30, |
|
% Increase / (Decrease)
|
|
Nine Months Ended
September 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2016
|
|
2015
|
|
|
2016
|
|
2015
|
|
||||||||||
|
Net product sales:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
EXPAREL
|
$
|
64,869
|
|
|
$
|
59,729
|
|
|
9%
|
|
$
|
194,374
|
|
|
$
|
172,657
|
|
|
13%
|
|
DepoCyt(e) and other product sales
|
1,250
|
|
|
1,421
|
|
|
(12)%
|
|
3,935
|
|
|
3,640
|
|
|
8%
|
||||
|
Total net product sales
|
66,119
|
|
|
61,150
|
|
|
8%
|
|
198,309
|
|
|
176,297
|
|
|
12%
|
||||
|
Collaborative licensing and milestone revenue
|
1,357
|
|
|
357
|
|
|
280%
|
|
3,069
|
|
|
1,069
|
|
|
187%
|
||||
|
Royalty revenue
|
879
|
|
|
706
|
|
|
25%
|
|
2,091
|
|
|
2,310
|
|
|
(9)%
|
||||
|
Total revenues
|
$
|
68,355
|
|
|
$
|
62,213
|
|
|
10%
|
|
$
|
203,469
|
|
|
$
|
179,676
|
|
|
13%
|
|
|
Three Months Ended
September 30, |
|
% Increase / (Decrease)
|
|
Nine Months Ended
September 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2016
|
|
2015
|
|
|
2016
|
|
2015
|
|
||||||||||
|
Cost of goods sold
|
$
|
43,152
|
|
|
$
|
15,901
|
|
|
171%
|
|
$
|
86,483
|
|
|
$
|
52,409
|
|
|
65%
|
|
Gross margin *
|
36
|
%
|
|
74
|
%
|
|
|
|
57
|
%
|
|
71
|
%
|
|
|
||||
|
|
Three Months Ended
September 30, |
|
% Increase / (Decrease)
|
|
Nine Months Ended
September 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2016
|
|
2015
|
|
|
2016
|
|
2015
|
|
||||||||||
|
Clinical development
|
$
|
5,665
|
|
|
$
|
2,119
|
|
|
167%
|
|
$
|
14,576
|
|
|
$
|
5,281
|
|
|
176%
|
|
Product development and other
|
3,399
|
|
|
2,704
|
|
|
26%
|
|
11,435
|
|
|
7,088
|
|
|
61%
|
||||
|
Stock-based compensation
|
690
|
|
|
1,070
|
|
|
(36)%
|
|
2,598
|
|
|
3,140
|
|
|
(17)%
|
||||
|
Total research and development expense
|
$
|
9,754
|
|
|
$
|
5,893
|
|
|
66%
|
|
$
|
28,609
|
|
|
$
|
15,509
|
|
|
84%
|
|
% of total revenues
|
14
|
%
|
|
9
|
%
|
|
|
|
14
|
%
|
|
9
|
%
|
|
|
||||
|
|
Three Months Ended
September 30, |
|
% Increase / (Decrease)
|
|
Nine Months Ended
September 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2016
|
|
2015
|
|
|
2016
|
|
2015
|
|
||||||||||
|
Sales and marketing
|
$
|
21,490
|
|
|
$
|
18,434
|
|
|
17%
|
|
$
|
69,437
|
|
|
$
|
56,422
|
|
|
23%
|
|
General and administrative
|
9,780
|
|
|
10,810
|
|
|
(10)%
|
|
32,371
|
|
|
28,947
|
|
|
12%
|
||||
|
Stock-based compensation
|
5,044
|
|
|
6,066
|
|
|
(17)%
|
|
16,132
|
|
|
16,121
|
|
|
—%
|
||||
|
Total selling, general and administrative expenses
|
$
|
36,314
|
|
|
$
|
35,310
|
|
|
3%
|
|
$
|
117,940
|
|
|
$
|
101,490
|
|
|
16%
|
|
% of total revenues
|
53
|
%
|
|
57
|
%
|
|
|
|
58
|
%
|
|
56
|
%
|
|
|
||||
|
|
Three Months Ended
September 30, |
|
% Increase / (Decrease)
|
|
Nine Months Ended
September 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2016
|
|
2015
|
|
|
2016
|
|
2015
|
|
||||||||||
|
Interest income
|
$
|
346
|
|
|
$
|
171
|
|
|
102%
|
|
$
|
923
|
|
|
$
|
504
|
|
|
83%
|
|
Interest expense
|
(1,601
|
)
|
|
(1,905
|
)
|
|
(16)%
|
|
(5,203
|
)
|
|
(5,842
|
)
|
|
(11)%
|
||||
|
Royalty interest obligation
|
—
|
|
|
—
|
|
|
N/A
|
|
—
|
|
|
(71
|
)
|
|
(100)%
|
||||
|
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
N/A
|
|
—
|
|
|
(51
|
)
|
|
(100)%
|
||||
|
Other, net
|
(8
|
)
|
|
(8
|
)
|
|
—%
|
|
(8
|
)
|
|
(82
|
)
|
|
(90)%
|
||||
|
Total other expense, net
|
$
|
(1,263
|
)
|
|
$
|
(1,742
|
)
|
|
(27)%
|
|
$
|
(4,288
|
)
|
|
$
|
(5,542
|
)
|
|
(23)%
|
|
|
Three Months Ended
September 30, |
|
% Increase / (Decrease)
|
|
Nine Months Ended
September 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2016
|
|
2015
|
|
|
2016
|
|
2015
|
|
||||||||||
|
Income tax expense
|
$
|
36
|
|
|
$
|
281
|
|
|
(87)%
|
|
$
|
126
|
|
|
$
|
372
|
|
|
(66)%
|
|
Effective tax rate
|
0
|
%
|
|
8
|
%
|
|
|
|
0
|
%
|
|
8
|
%
|
|
|
||||
|
|
|
Nine Months Ended
September 30, |
||||||
|
Consolidated Statement of Cash Flows Data:
|
|
2016
|
|
2015
|
||||
|
Net cash provided by (used in):
|
|
|
|
|
||||
|
Operating activities
|
|
$
|
16,104
|
|
|
$
|
11,027
|
|
|
Investing activities
|
|
(54,837
|
)
|
|
(26,552
|
)
|
||
|
Financing activities
|
|
6,191
|
|
|
8,527
|
|
||
|
Net decrease in cash and cash equivalents
|
|
$
|
(32,542
|
)
|
|
$
|
(6,998
|
)
|
|
•
|
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, England 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, which could be up to an aggregate of $36.0 million if certain milestones pertaining to net sales of DepoBupivacaine products, including EXPAREL, are met;
|
|
•
|
costs related to legal and regulatory issues;
|
|
•
|
the costs of performing additional clinical trials for EXPAREL and pipeline drug candidates, including DepoMLX and DepoTXA and 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 research and development, products, businesses and technologies.
|
|
September 30, 2016
|
|
Returns Allowances
|
|
Prompt Payment Discounts
|
|
Wholesaler Service Fees
|
|
Volume
Rebates and Chargebacks |
|
Total
|
||||||||||
|
Balance at December 31, 2015
|
|
$
|
1,733
|
|
|
$
|
625
|
|
|
$
|
745
|
|
|
$
|
797
|
|
|
$
|
3,900
|
|
|
Provision
|
|
506
|
|
|
3,978
|
|
|
3,016
|
|
|
1,587
|
|
|
9,087
|
|
|||||
|
Payments/Credits
|
|
(1,022
|
)
|
|
(4,073
|
)
|
|
(3,202
|
)
|
|
(1,657
|
)
|
|
(9,954
|
)
|
|||||
|
Balance at September 30, 2016
|
|
$
|
1,217
|
|
|
$
|
530
|
|
|
$
|
559
|
|
|
$
|
727
|
|
|
$
|
3,033
|
|
|
September 30, 2015
|
|
Returns Allowances
|
|
Prompt Payment Discounts
|
|
Wholesaler Service Fees
|
|
Volume
Rebates and Chargebacks |
|
Total
|
||||||||||
|
Balance at December 31, 2014
|
|
$
|
1,559
|
|
|
$
|
575
|
|
|
$
|
588
|
|
|
$
|
321
|
|
|
$
|
3,043
|
|
|
Provision
|
|
256
|
|
|
3,535
|
|
|
2,548
|
|
|
1,317
|
|
|
7,656
|
|
|||||
|
Payments/Credits
|
|
(70
|
)
|
|
(3,512
|
)
|
|
(2,545
|
)
|
|
(1,002
|
)
|
|
(7,129
|
)
|
|||||
|
Balance at September 30, 2015
|
|
$
|
1,745
|
|
|
$
|
598
|
|
|
$
|
591
|
|
|
$
|
636
|
|
|
$
|
3,570
|
|
|
Exhibit No.
|
|
Description
|
|
|
|
|
|
31.1
|
|
Certification of Chief Executive Officer and Chairman pursuant to Rule 13a-14(a) and 15d-14(a), as amended.*
|
|
|
|
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a), as amended.*
|
|
|
|
|
|
32.1
|
|
Certification of 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 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 September 30, 2016, 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:
|
November 2, 2016
|
/s/ DAVID STACK
|
|
|
|
David Stack
|
|
|
|
Chief Executive Officer and Chairman
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
Dated:
|
November 2, 2016
|
/s/ CHARLES A. REINHART, III
|
|
|
|
Charles A. Reinhart, III
|
|
|
|
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 |
|---|