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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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Emerging growth company
o
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PACIRA PHARMACEUTICALS, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTER ENDED SEPTEMBER 30, 2017
TABLE OF CONTENTS
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Page #
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||
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||
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||
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||
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PACIRA PHARMACEUTICALS, INC.
(In thousands, except share and per share amounts)
(Unaudited)
|
|||||||
|
|
September 30,
2017 |
|
December 31,
2016 |
||||
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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
|
$
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26,216
|
|
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$
|
35,944
|
|
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Short-term investments
|
267,864
|
|
|
136,653
|
|
||
|
Accounts receivable, net
|
27,021
|
|
|
29,937
|
|
||
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Inventories, net
|
39,112
|
|
|
31,278
|
|
||
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Prepaid expenses and other current assets
|
5,622
|
|
|
9,277
|
|
||
|
Total current assets
|
365,835
|
|
|
243,089
|
|
||
|
Long-term investments
|
80,807
|
|
|
—
|
|
||
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Fixed assets, net
|
105,947
|
|
|
101,016
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|
||
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Goodwill
|
52,956
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|
|
46,737
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|
||
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Other assets
|
545
|
|
|
624
|
|
||
|
Total assets
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$
|
606,090
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|
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$
|
391,466
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||||
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LIABILITIES AND STOCKHOLDERS’ EQUITY
|
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|
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Current liabilities:
|
|
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|
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|
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Accounts payable
|
$
|
12,278
|
|
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$
|
7,511
|
|
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Accrued expenses
|
39,701
|
|
|
37,261
|
|
||
|
Convertible senior notes
|
320
|
|
|
—
|
|
||
|
Income taxes payable
|
38
|
|
|
66
|
|
||
|
Total current liabilities
|
52,337
|
|
|
44,838
|
|
||
|
Convertible senior notes
|
272,721
|
|
|
108,738
|
|
||
|
Other liabilities
|
16,232
|
|
|
18,914
|
|
||
|
Total liabilities
|
341,290
|
|
|
172,490
|
|
||
|
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, 2017 and December 31, 2016 |
—
|
|
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—
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|
||
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Common stock, par value $0.001, 250,000,000 shares authorized; 40,564,766 shares issued and
outstanding at September 30, 2017; 37,480,952 shares issued and outstanding at December 31, 2016 |
41
|
|
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37
|
|
||
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Additional paid-in capital
|
658,557
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|
565,207
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|
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Accumulated deficit
|
(393,731
|
)
|
|
(346,238
|
)
|
||
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Accumulated other comprehensive loss
|
(67
|
)
|
|
(30
|
)
|
||
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Total stockholders’ equity
|
264,800
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|
|
218,976
|
|
||
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Total liabilities and stockholders’ equity
|
$
|
606,090
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|
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$
|
391,466
|
|
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PACIRA PHARMACEUTICALS, INC.
(In thousands, except per share amounts)
(Unaudited)
|
|||||||||||||||
|
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Three Months Ended
September 30, |
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Nine Months Ended
September 30, |
||||||||||||
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2017
|
|
2016
|
|
2017
|
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2016
|
||||||||
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Revenues:
|
|
|
|
|
|
|
|
|
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|
|
||||
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Net product sales
|
$
|
66,951
|
|
|
$
|
66,119
|
|
|
$
|
205,515
|
|
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$
|
198,309
|
|
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Collaborative licensing and milestone revenue
|
26
|
|
|
1,357
|
|
|
361
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|
|
3,069
|
|
||||
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Royalty revenue
|
358
|
|
|
879
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|
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1,676
|
|
|
2,091
|
|
||||
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Total revenues
|
67,335
|
|
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68,355
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|
|
207,552
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|
|
203,469
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|
||||
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Operating expenses:
|
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|
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|
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||||
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Cost of goods sold
|
18,228
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43,152
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|
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66,621
|
|
|
86,483
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|
||||
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Research and development
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11,775
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9,754
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47,262
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|
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28,609
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|
||||
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Selling, general and administrative
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40,644
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36,314
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|
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122,316
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|
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117,940
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|
||||
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Product discontinuation
|
260
|
|
|
—
|
|
|
4,754
|
|
|
—
|
|
||||
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Total operating expenses
|
70,907
|
|
|
89,220
|
|
|
240,953
|
|
|
233,032
|
|
||||
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Loss from operations
|
(3,572
|
)
|
|
(20,865
|
)
|
|
(33,401
|
)
|
|
(29,563
|
)
|
||||
|
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
|
|
||||
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Interest income
|
1,068
|
|
|
346
|
|
|
2,805
|
|
|
923
|
|
||||
|
Interest expense
|
(5,127
|
)
|
|
(1,601
|
)
|
|
(12,942
|
)
|
|
(5,203
|
)
|
||||
|
Loss on early extinguishment of debt
|
—
|
|
|
—
|
|
|
(3,732
|
)
|
|
—
|
|
||||
|
Other, net
|
79
|
|
|
(8
|
)
|
|
169
|
|
|
(8
|
)
|
||||
|
Total other expense, net
|
(3,980
|
)
|
|
(1,263
|
)
|
|
(13,700
|
)
|
|
(4,288
|
)
|
||||
|
Loss before income taxes
|
(7,552
|
)
|
|
(22,128
|
)
|
|
(47,101
|
)
|
|
(33,851
|
)
|
||||
|
Income tax expense
|
(45
|
)
|
|
(36
|
)
|
|
(105
|
)
|
|
(126
|
)
|
||||
|
Net loss
|
$
|
(7,597
|
)
|
|
$
|
(22,164
|
)
|
|
$
|
(47,206
|
)
|
|
$
|
(33,977
|
)
|
|
|
|
|
|
|
|
|
|
||||||||
|
Net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Basic and diluted net loss per common share
|
$
|
(0.19
|
)
|
|
$
|
(0.59
|
)
|
|
$
|
(1.19
|
)
|
|
$
|
(0.91
|
)
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
||||||
|
Basic and diluted
|
40,463
|
|
|
37,312
|
|
|
39,540
|
|
|
37,171
|
|
||||
|
PACIRA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In thousands)
(Unaudited)
|
|||||||||||||||
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
Net loss
|
$
|
(7,597
|
)
|
|
$
|
(22,164
|
)
|
|
$
|
(47,206
|
)
|
|
$
|
(33,977
|
)
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Net unrealized gain (loss) on investments
|
(3
|
)
|
|
(166
|
)
|
|
(37
|
)
|
|
24
|
|
||||
|
Total other comprehensive income (loss)
|
(3
|
)
|
|
(166
|
)
|
|
(37
|
)
|
|
24
|
|
||||
|
Comprehensive loss
|
$
|
(7,600
|
)
|
|
$
|
(22,330
|
)
|
|
$
|
(47,243
|
)
|
|
$
|
(33,953
|
)
|
|
PACIRA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2017
(In thousands)
(Unaudited)
|
||||||||||||||||||||||
|
|
Common Stock
|
|
Additional
Paid-In Capital |
|
Accumulated
Deficit |
|
Accumulated
Other Comprehensive Loss |
|
|
|||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
|
Total
|
||||||||||||||
|
Balance at December 31, 2016
|
37,481
|
|
|
$
|
37
|
|
|
$
|
565,207
|
|
|
$
|
(346,238
|
)
|
|
$
|
(30
|
)
|
|
$
|
218,976
|
|
|
Cumulative effect adjustment of the adoption
of Accounting Standards Update 2016-09 (Note 2) |
—
|
|
|
—
|
|
|
287
|
|
|
(287
|
)
|
|
—
|
|
|
—
|
|
|||||
|
Exercise of stock options
|
459
|
|
|
1
|
|
|
5,303
|
|
|
—
|
|
|
—
|
|
|
5,304
|
|
|||||
|
Vested restricted stock units
|
99
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
|
Shares issued under employee stock
purchase plan |
36
|
|
|
—
|
|
|
1,056
|
|
|
—
|
|
|
—
|
|
|
1,056
|
|
|||||
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
23,407
|
|
|
—
|
|
|
—
|
|
|
23,407
|
|
|||||
|
Issuance of common stock upon
conversion of 2019 convertible senior notes |
2,490
|
|
|
3
|
|
|
120,957
|
|
|
—
|
|
|
—
|
|
|
120,960
|
|
|||||
|
Retirement of equity component
of 2019 convertible senior notes |
—
|
|
|
—
|
|
|
(126,328
|
)
|
|
—
|
|
|
—
|
|
|
(126,328
|
)
|
|||||
|
Equity component of 2022 convertible
senior notes issued, net |
—
|
|
|
—
|
|
|
68,668
|
|
|
—
|
|
|
—
|
|
|
68,668
|
|
|||||
|
Net unrealized loss on investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(37
|
)
|
|
(37
|
)
|
|||||
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(47,206
|
)
|
|
—
|
|
|
(47,206
|
)
|
|||||
|
Balance at September 30, 2017
|
40,565
|
|
|
$
|
41
|
|
|
$
|
658,557
|
|
|
$
|
(393,731
|
)
|
|
$
|
(67
|
)
|
|
$
|
264,800
|
|
|
PACIRA PHARMACEUTICALS, INC.
(In thousands)
(Unaudited)
|
|||||||
|
|
Nine Months Ended
September 30, |
||||||
|
|
2017
|
|
2016
|
||||
|
|
|
|
(Note 2)
|
||||
|
Operating activities:
|
|
|
|
|
|
||
|
Net loss
|
$
|
(47,206
|
)
|
|
$
|
(33,977
|
)
|
|
Adjustments to reconcile net loss to net cash provided by operating activities:
|
|
|
|
|
|
||
|
Depreciation of fixed assets and amortization of intangibles
|
10,174
|
|
|
9,659
|
|
||
|
Amortization of unfavorable lease obligation and debt issuance costs
|
884
|
|
|
359
|
|
||
|
Amortization of debt discount
|
7,365
|
|
|
3,066
|
|
||
|
Loss on early extinguishment of debt
|
3,732
|
|
|
—
|
|
||
|
Loss on disposal of fixed assets
|
2,139
|
|
|
—
|
|
||
|
Stock-based compensation
|
23,407
|
|
|
23,516
|
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
||
|
Accounts receivable, net
|
2,916
|
|
|
(910
|
)
|
||
|
Inventories, net
|
(7,834
|
)
|
|
24,169
|
|
||
|
Prepaid expenses and other assets
|
3,734
|
|
|
(4,202
|
)
|
||
|
Accounts payable, accrued expenses and income taxes payable
|
4,542
|
|
|
(5,691
|
)
|
||
|
Other liabilities
|
(2,999
|
)
|
|
115
|
|
||
|
Net cash provided by operating activities
|
854
|
|
|
16,104
|
|
||
|
Investing activities:
|
|
|
|
|
|
||
|
Purchases of fixed assets
|
(14,190
|
)
|
|
(19,827
|
)
|
||
|
Purchases of investments
|
(436,017
|
)
|
|
(158,390
|
)
|
||
|
Sales of investments
|
223,962
|
|
|
137,170
|
|
||
|
Payment of contingent consideration
|
(6,219
|
)
|
|
(13,790
|
)
|
||
|
Net cash used in investing activities
|
(232,464
|
)
|
|
(54,837
|
)
|
||
|
Financing activities:
|
|
|
|
|
|
||
|
Proceeds from exercise of stock options
|
5,304
|
|
|
5,200
|
|
||
|
Proceeds from shares issued under employee stock purchase plan
|
1,056
|
|
|
995
|
|
||
|
Proceeds from 2022 convertible senior notes
|
345,000
|
|
|
—
|
|
||
|
Repayment of 2019 convertible senior notes
|
(118,193
|
)
|
|
(4
|
)
|
||
|
Payment of debt issuance and financing costs
|
(11,000
|
)
|
|
—
|
|
||
|
Costs for conversion of convertible senior notes
|
(285
|
)
|
|
—
|
|
||
|
Net cash provided by financing activities
|
221,882
|
|
|
6,191
|
|
||
|
Net decrease in cash and cash equivalents
|
(9,728
|
)
|
|
(32,542
|
)
|
||
|
Cash and cash equivalents, beginning of period
|
35,944
|
|
|
56,984
|
|
||
|
Cash and cash equivalents, end of period
|
$
|
26,216
|
|
|
$
|
24,442
|
|
|
Supplemental cash flow information:
|
|
|
|
|
|
||
|
Cash paid for interest
|
$
|
6,896
|
|
|
$
|
3,852
|
|
|
Cash paid for income taxes, net of refunds
|
$
|
133
|
|
|
$
|
253
|
|
|
Non-cash investing and financing activities:
|
|
|
|
||||
|
Issuance of common stock from conversion of 2019 convertible senior notes
|
$
|
120,960
|
|
|
$
|
—
|
|
|
Retirement of equity component of 2019 convertible senior notes
|
$
|
(126,328
|
)
|
|
$
|
—
|
|
|
Net increase (decrease) in accrued fixed assets
|
$
|
3,054
|
|
|
$
|
(185
|
)
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
Largest wholesaler
|
34%
|
|
31%
|
|
35%
|
|
32%
|
|
Second largest wholesaler
|
30%
|
|
27%
|
|
29%
|
|
27%
|
|
Third largest wholesaler
|
26%
|
|
27%
|
|
26%
|
|
27%
|
|
|
90%
|
|
85%
|
|
90%
|
|
86%
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2017
|
|
2016
|
||||
|
Raw materials
|
$
|
14,113
|
|
|
$
|
11,742
|
|
|
Work-in-process
|
9,013
|
|
|
11,621
|
|
||
|
Finished goods
|
15,986
|
|
|
7,915
|
|
||
|
Total
|
$
|
39,112
|
|
|
$
|
31,278
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2017
|
|
2016
|
||||
|
Machinery and laboratory equipment
|
$
|
35,496
|
|
|
$
|
34,309
|
|
|
Leasehold improvements
|
34,723
|
|
|
33,787
|
|
||
|
Computer equipment and software
|
6,985
|
|
|
5,623
|
|
||
|
Office furniture and equipment
|
1,603
|
|
|
1,606
|
|
||
|
Construction in progress
|
72,690
|
|
|
63,201
|
|
||
|
Total
|
151,497
|
|
|
138,526
|
|
||
|
Less: accumulated depreciation
|
(45,550
|
)
|
|
(37,510
|
)
|
||
|
Fixed assets, net
|
$
|
105,947
|
|
|
$
|
101,016
|
|
|
(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, 2016
|
$
|
46,737
|
|
|
Percentage payments on collections of net sales of DepoBupivacaine products
|
6,219
|
|
|
|
Balance at September 30, 2017
|
$
|
52,956
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2017
|
|
2016
|
||||
|
2.375% convertible senior notes due 2022
|
$
|
345,000
|
|
|
$
|
—
|
|
|
Deferred financing costs
|
(7,880
|
)
|
|
—
|
|
||
|
Discount on debt
|
(64,399
|
)
|
|
—
|
|
||
|
Total debt, net of debt discount and deferred financing costs
|
$
|
272,721
|
|
|
$
|
—
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2017
|
|
2016
|
||||
|
3.25% convertible senior notes due 2019
|
$
|
338
|
|
|
$
|
118,531
|
|
|
Deferred financing costs
|
(2
|
)
|
|
(1,276
|
)
|
||
|
Discount on debt
|
(16
|
)
|
|
(8,517
|
)
|
||
|
Total debt, net of debt discount and deferred financing costs
|
$
|
320
|
|
|
$
|
108,738
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
Contractual interest expense
|
$
|
2,051
|
|
|
$
|
963
|
|
|
$
|
5,293
|
|
|
$
|
2,890
|
|
|
Amortization of debt issuance costs
|
393
|
|
|
153
|
|
|
984
|
|
|
459
|
|
||||
|
Amortization of debt discount
|
3,003
|
|
|
1,022
|
|
|
7,365
|
|
|
3,066
|
|
||||
|
Capitalized interest and other (Note 4)
|
(320
|
)
|
|
(537
|
)
|
|
(700
|
)
|
|
(1,212
|
)
|
||||
|
Total
|
$
|
5,127
|
|
|
$
|
1,601
|
|
|
$
|
12,942
|
|
|
$
|
5,203
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Effective interest rate on convertible senior notes
|
7.81
|
%
|
|
7.22
|
%
|
|
7.75
|
%
|
|
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
|
||||||||||||
|
September 30, 2017
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|||||||||
|
2.375% convertible senior notes due 2022
(1)
|
|
$
|
272,721
|
|
|
$
|
—
|
|
|
$
|
335,513
|
|
|
$
|
—
|
|
|
3.25% convertible senior notes due 2019
(2)
|
|
$
|
320
|
|
|
$
|
—
|
|
|
$
|
509
|
|
|
$
|
—
|
|
|
September 30, 2017 Debt Securities
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
(Level 2) |
||||||||
|
Short-term:
|
|
|
|
|
|
|
|
|
||||||||
|
Asset-backed securities
|
|
$
|
35,281
|
|
|
$
|
—
|
|
|
$
|
(4
|
)
|
|
$
|
35,277
|
|
|
Commercial paper
|
|
34,350
|
|
|
5
|
|
|
(1
|
)
|
|
34,354
|
|
||||
|
Corporate bonds
|
|
198,222
|
|
|
35
|
|
|
(24
|
)
|
|
198,233
|
|
||||
|
Subtotal
|
|
267,853
|
|
|
40
|
|
|
(29
|
)
|
|
267,864
|
|
||||
|
Long-term:
|
|
|
|
|
|
|
|
|
||||||||
|
Asset-backed securities
|
|
24,192
|
|
|
—
|
|
|
(16
|
)
|
|
24,176
|
|
||||
|
Corporate bonds
|
|
56,693
|
|
|
—
|
|
|
(62
|
)
|
|
56,631
|
|
||||
|
Subtotal
|
|
80,885
|
|
|
—
|
|
|
(78
|
)
|
|
80,807
|
|
||||
|
Total
|
|
$
|
348,738
|
|
|
$
|
40
|
|
|
$
|
(107
|
)
|
|
$
|
348,671
|
|
|
December 31, 2016 Debt Securities
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
(Level 2) |
||||||||
|
Short-term:
|
|
|
|
|
|
|
|
|
||||||||
|
Asset-backed securities
|
|
$
|
9,012
|
|
|
$
|
—
|
|
|
$
|
(2
|
)
|
|
$
|
9,010
|
|
|
Commercial paper
|
|
39,530
|
|
|
8
|
|
|
(15
|
)
|
|
39,523
|
|
||||
|
Corporate bonds
|
|
88,141
|
|
|
11
|
|
|
(32
|
)
|
|
88,120
|
|
||||
|
Total
|
|
$
|
136,683
|
|
|
$
|
19
|
|
|
$
|
(49
|
)
|
|
$
|
136,653
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
Cost of goods sold
|
|
$
|
1,502
|
|
|
$
|
1,627
|
|
|
$
|
4,272
|
|
|
$
|
4,786
|
|
|
Research and development
|
|
824
|
|
|
690
|
|
|
2,128
|
|
|
2,598
|
|
||||
|
Selling, general and administrative
|
|
6,337
|
|
|
5,044
|
|
|
17,007
|
|
|
16,132
|
|
||||
|
Total
|
|
$
|
8,663
|
|
|
$
|
7,361
|
|
|
$
|
23,407
|
|
|
$
|
23,516
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Stock-based compensation from:
|
|
|
|
|
|
|
|
|
||||||||
|
Stock options (employee awards)
|
|
$
|
6,310
|
|
|
$
|
5,684
|
|
|
$
|
17,968
|
|
|
$
|
18,318
|
|
|
Stock options (consultant awards)
|
|
36
|
|
|
150
|
|
|
118
|
|
|
872
|
|
||||
|
Restricted stock units (employee awards)
|
|
2,161
|
|
|
1,425
|
|
|
4,772
|
|
|
3,650
|
|
||||
|
Employee stock purchase plan
|
|
156
|
|
|
102
|
|
|
549
|
|
|
676
|
|
||||
|
Total
|
|
$
|
8,663
|
|
|
$
|
7,361
|
|
|
$
|
23,407
|
|
|
$
|
23,516
|
|
|
Stock Options
|
|
Number of Options
|
|
Weighted Average Exercise Price
|
|||
|
Outstanding at December 31, 2016
|
|
5,207,743
|
|
|
$
|
42.16
|
|
|
Granted
|
|
1,009,650
|
|
|
44.29
|
|
|
|
Exercised
|
|
(458,535
|
)
|
|
11.57
|
|
|
|
Forfeited
|
|
(389,720
|
)
|
|
49.76
|
|
|
|
Expired
|
|
(198,038
|
)
|
|
75.49
|
|
|
|
Outstanding at September 30, 2017
|
|
5,171,100
|
|
|
43.43
|
|
|
|
Restricted Stock Units
|
|
Number of Units
|
|
Weighted Average Grant Date Fair Value
|
|||
|
Unvested at December 31, 2016
|
|
364,403
|
|
|
$
|
52.85
|
|
|
Granted
|
|
338,583
|
|
|
44.22
|
|
|
|
Vested
|
|
(99,504
|
)
|
|
54.15
|
|
|
|
Forfeited
|
|
(63,731
|
)
|
|
51.17
|
|
|
|
Unvested at September 30, 2017
|
|
539,751
|
|
|
47.38
|
|
|
|
|
|
Nine Months Ended September 30, 2017
|
|
Expected dividend yield
|
|
None
|
|
Risk free interest rate
|
|
1.80%
|
|
Expected volatility
|
|
51.4%
|
|
Expected term of options
|
|
5.32 years
|
|
|
|
Nine Months Ended
September 30, |
||||||
|
Net unrealized gains (losses) from available for sale investments:
|
|
2017
|
|
2016
|
||||
|
Balance at beginning of period
|
|
$
|
(30
|
)
|
|
$
|
(52
|
)
|
|
Other comprehensive income (loss) before reclassifications
|
|
(37
|
)
|
|
24
|
|
||
|
Amounts reclassified from accumulated other comprehensive income (loss)
|
|
—
|
|
|
—
|
|
||
|
Balance at end of period
|
|
$
|
(67
|
)
|
|
$
|
(28
|
)
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|||||||||
|
Numerator:
|
|
|
|
|
|
|
|
||||||||
|
Net loss
|
$
|
(7,597
|
)
|
|
$
|
(22,164
|
)
|
|
$
|
(47,206
|
)
|
|
$
|
(33,977
|
)
|
|
Denominator:
|
|
|
|
|
|
|
|
||||||||
|
Weighted average common shares outstanding
|
40,463
|
|
|
37,312
|
|
|
39,540
|
|
|
37,171
|
|
||||
|
Net loss per share:
|
|
|
|
|
|
|
|
||||||||
|
Basic and diluted net loss per common share
|
$
|
(0.19
|
)
|
|
$
|
(0.59
|
)
|
|
$
|
(1.19
|
)
|
|
$
|
(0.91
|
)
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||
|
Weighted average number of stock options
|
5,405
|
|
|
4,632
|
|
|
5,203
|
|
|
4,403
|
|
|
Weighted average number of RSUs
|
549
|
|
|
372
|
|
|
426
|
|
|
265
|
|
|
Conversion premium on the 2019 Notes
|
5
|
|
|
1,750
|
|
|
546
|
|
|
2,288
|
|
|
Weighted average number of warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
1
|
|
|
Weighted average ESPP purchase options
|
22
|
|
|
20
|
|
|
32
|
|
|
22
|
|
|
Total
|
5,981
|
|
|
6,774
|
|
|
6,207
|
|
|
6,979
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
Loss before income taxes:
|
|
|
|
|
|
|
|
||||||||
|
Domestic
|
$
|
(6,867
|
)
|
|
$
|
(21,780
|
)
|
|
$
|
(45,136
|
)
|
|
$
|
(32,806
|
)
|
|
Foreign
|
(685
|
)
|
|
(348
|
)
|
|
(1,965
|
)
|
|
(1,045
|
)
|
||||
|
Total loss before income taxes
|
$
|
(7,552
|
)
|
|
$
|
(22,128
|
)
|
|
$
|
(47,101
|
)
|
|
$
|
(33,851
|
)
|
|
Year
|
|
Aggregate Minimum Payments
|
||
|
2017 (remaining three months)
|
|
$
|
2,004
|
|
|
2018
|
|
8,063
|
|
|
|
2019
|
|
8,272
|
|
|
|
2020
|
|
6,389
|
|
|
|
2021
|
|
1,207
|
|
|
|
2022 through 2028
|
|
7,545
|
|
|
|
Total
|
|
$
|
33,480
|
|
|
|
Severance and Related Costs
|
|
Lease Costs
|
|
Write-Off of Property, Plant & Equipment and Inventory
|
|
Asset Retirement Obligations and Other Discontinuation Costs
|
|
Total
|
||||||||||
|
Balance at December 31, 2016
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Charges incurred
|
309
|
|
|
1,902
|
|
|
2,470
|
|
|
653
|
|
|
5,334
|
|
|||||
|
Cash payments made
|
(178
|
)
|
|
(437
|
)
|
|
—
|
|
|
(330
|
)
|
|
(945
|
)
|
|||||
|
Disposal of property, plant &
equipment and inventory |
—
|
|
|
—
|
|
|
(2,470
|
)
|
|
—
|
|
|
(2,470
|
)
|
|||||
|
Adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
|
Balance at September 30, 2017
|
$
|
131
|
|
|
$
|
1,465
|
|
|
$
|
—
|
|
|
$
|
323
|
|
|
$
|
1,919
|
|
|
•
|
In October 2017, we made an initial cash investment of $15 million in TELA Bio, Inc., or TELA Bio, a privately-held surgical reconstruction company that markets its proprietary OviTex
TM
portfolio of products for ventral hernia repair and abdominal wall reconstruction. OviTex Reinforced BioScaffolds (RBSs) are intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. We may be required to invest up to an additional $10 million in TELA Bio under certain performance scenarios or at our own election.
|
|
•
|
In October 2017, we announced that the FDA accepted the resubmission of our sNDA seeking expansion of the EXPAREL label to include administration via nerve block for prolonged regional analgesia. The expected action
|
|
•
|
In September 2017, we announced a collaboration with Aetna, one of the nation’s leading diversified health care benefits companies, with the support of the American Association of Oral and Maxillofacial Surgeons, on a national program aimed at reducing the number of opioid tablets dispensed to patients undergoing impacted third molar (wisdom tooth) extractions by at least 50 percent through the utilization of EXPAREL to provide prolonged non-opioid postsurgical pain control. Aetna will reimburse oral surgeons enrolled in the program for their use of EXPAREL in impacted third molar extraction cases performed once the surgeons have completed training on use of the product.
|
|
|
Three Months Ended
September 30, |
|
% Increase / (Decrease)
|
|
Nine Months Ended
September 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2017
|
|
2016
|
|
|
2017
|
|
2016
|
|
||||||||||
|
Net product sales:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
EXPAREL
|
$
|
66,780
|
|
|
$
|
64,869
|
|
|
3%
|
|
$
|
204,254
|
|
|
$
|
194,374
|
|
|
5%
|
|
DepoCyt(e) and other product sales
|
171
|
|
|
1,250
|
|
|
(86)%
|
|
1,261
|
|
|
3,935
|
|
|
(68)%
|
||||
|
Total net product sales
|
66,951
|
|
|
66,119
|
|
|
1%
|
|
205,515
|
|
|
198,309
|
|
|
4%
|
||||
|
Collaborative licensing and milestone revenue
|
26
|
|
|
1,357
|
|
|
(98)%
|
|
361
|
|
|
3,069
|
|
|
(88)%
|
||||
|
Royalty revenue
|
358
|
|
|
879
|
|
|
(59)%
|
|
1,676
|
|
|
2,091
|
|
|
(20)%
|
||||
|
Total revenues
|
$
|
67,335
|
|
|
$
|
68,355
|
|
|
(1)%
|
|
$
|
207,552
|
|
|
$
|
203,469
|
|
|
2%
|
|
|
Three Months Ended
September 30, |
|
% Increase / (Decrease)
|
|
Nine Months Ended
September 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2017
|
|
2016
|
|
|
2017
|
|
2016
|
|
||||||||||
|
Cost of goods sold
|
$
|
18,228
|
|
|
$
|
43,152
|
|
|
(58)%
|
|
$
|
66,621
|
|
|
$
|
86,483
|
|
|
(23)%
|
|
Gross margin
|
73
|
%
|
|
37
|
%
|
|
|
|
68
|
%
|
|
57
|
%
|
|
|
||||
|
|
Three Months Ended
September 30, |
|
% Increase / (Decrease)
|
|
Nine Months Ended
September 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2017
|
|
2016
|
|
|
2017
|
|
2016
|
|
||||||||||
|
Clinical development
|
$
|
6,301
|
|
|
$
|
5,665
|
|
|
11%
|
|
$
|
29,738
|
|
|
$
|
14,576
|
|
|
104%
|
|
Product development and other
|
4,650
|
|
|
3,399
|
|
|
37%
|
|
15,396
|
|
|
11,435
|
|
|
35%
|
||||
|
Stock-based compensation
|
824
|
|
|
690
|
|
|
19%
|
|
2,128
|
|
|
2,598
|
|
|
(18)%
|
||||
|
Total research and development expense
|
$
|
11,775
|
|
|
$
|
9,754
|
|
|
21%
|
|
$
|
47,262
|
|
|
$
|
28,609
|
|
|
65%
|
|
% of total revenues
|
17
|
%
|
|
14
|
%
|
|
|
|
23
|
%
|
|
14
|
%
|
|
|
||||
|
|
Three Months Ended
September 30, |
|
% Increase / (Decrease)
|
|
Nine Months Ended
September 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2017
|
|
2016
|
|
|
2017
|
|
2016
|
|
||||||||||
|
Sales and marketing
|
$
|
24,557
|
|
|
$
|
21,490
|
|
|
14%
|
|
$
|
72,344
|
|
|
$
|
69,437
|
|
|
4%
|
|
General and administrative
|
9,750
|
|
|
9,780
|
|
|
0%
|
|
32,965
|
|
|
32,371
|
|
|
2%
|
||||
|
Stock-based compensation
|
6,337
|
|
|
5,044
|
|
|
26%
|
|
17,007
|
|
|
16,132
|
|
|
5%
|
||||
|
Total selling, general and administrative
expenses |
$
|
40,644
|
|
|
$
|
36,314
|
|
|
12%
|
|
$
|
122,316
|
|
|
$
|
117,940
|
|
|
4%
|
|
% of total revenues
|
60
|
%
|
|
53
|
%
|
|
|
|
59
|
%
|
|
58
|
%
|
|
|
||||
|
|
Three Months Ended
September 30, |
|
% Increase / (Decrease)
|
|
Nine Months Ended
September 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2017
|
|
2016
|
|
|
2017
|
|
2016
|
|
||||||||||
|
Interest income
|
$
|
1,068
|
|
|
$
|
346
|
|
|
209%
|
|
$
|
2,805
|
|
|
$
|
923
|
|
|
204%
|
|
Interest expense
|
(5,127
|
)
|
|
(1,601
|
)
|
|
220%
|
|
(12,942
|
)
|
|
(5,203
|
)
|
|
149%
|
||||
|
Loss on early extinguishment of debt
|
—
|
|
|
—
|
|
|
N/A
|
|
(3,732
|
)
|
|
—
|
|
|
N/A
|
||||
|
Other, net
|
79
|
|
|
(8
|
)
|
|
N/A
|
|
169
|
|
|
(8
|
)
|
|
N/A
|
||||
|
Total other expense, net
|
$
|
(3,980
|
)
|
|
$
|
(1,263
|
)
|
|
215%
|
|
$
|
(13,700
|
)
|
|
$
|
(4,288
|
)
|
|
219%
|
|
|
Three Months Ended
September 30, |
|
% Increase / (Decrease)
|
|
Nine Months Ended
September 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2017
|
|
2016
|
|
|
2017
|
|
2016
|
|
||||||||||
|
Income tax expense
|
$
|
45
|
|
|
$
|
36
|
|
|
25%
|
|
$
|
105
|
|
|
$
|
126
|
|
|
(17)%
|
|
Effective tax rate
|
0
|
%
|
|
0
|
%
|
|
|
|
0
|
%
|
|
0
|
%
|
|
|
||||
|
|
|
Nine Months Ended
September 30, |
||||||
|
Condensed Consolidated Statement of Cash Flows Data:
|
|
2017
|
|
2016
|
||||
|
Net cash provided by (used in):
|
|
|
|
|
||||
|
Operating activities
|
|
$
|
854
|
|
|
$
|
16,104
|
|
|
Investing activities
|
|
(232,464
|
)
|
|
(54,837
|
)
|
||
|
Financing activities
|
|
221,882
|
|
|
6,191
|
|
||
|
Net decrease in cash and cash equivalents
|
|
$
|
(9,728
|
)
|
|
$
|
(32,542
|
)
|
|
•
|
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 2022 Notes elect to convert their 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, including the pediatric trials required by the FDA as a condition of approval;
|
|
•
|
the costs for the development and commercialization of other product candidates; and
|
|
•
|
the extent to which we acquire or invest in products, businesses and technologies.
|
|
September 30, 2017
|
|
Returns Allowances
|
|
Prompt Payment Discounts
|
|
Wholesaler Service Fees
|
|
Volume
Rebates and Chargebacks |
|
Total
|
||||||||||
|
Balance at December 31, 2016
|
|
$
|
1,346
|
|
|
$
|
595
|
|
|
$
|
735
|
|
|
$
|
1,124
|
|
|
$
|
3,800
|
|
|
Provision
|
|
536
|
|
|
4,200
|
|
|
3,182
|
|
|
3,015
|
|
|
10,933
|
|
|||||
|
Payments/Credits
|
|
(923
|
)
|
|
(4,229
|
)
|
|
(3,314
|
)
|
|
(3,265
|
)
|
|
(11,731
|
)
|
|||||
|
Balance at September 30, 2017
|
|
$
|
959
|
|
|
$
|
566
|
|
|
$
|
603
|
|
|
$
|
874
|
|
|
$
|
3,002
|
|
|
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
|
|
|
Exhibit No.
|
|
Description
|
|
|
|
|
|
31.1
|
|
|
|
|
|
|
|
31.2
|
|
|
|
|
|
|
|
32.1
|
|
|
|
|
|
|
|
32.2
|
|
|
|
|
|
|
|
101
|
|
The following materials from the Quarterly Report on Form 10-Q of Pacira Pharmaceuticals, Inc. for the quarter ended September 30, 2017, formatted in XBRL (eXtensible Business Reporting Language): (i) the Condensed Consolidated Balance Sheets; (ii) the Condensed Consolidated Statements of Operations; (iii) the Condensed Consolidated Statements of Comprehensive Loss; (iv) the Condensed Consolidated Statement of Stockholders’ Equity; (v) the Condensed Consolidated Statements of Cash Flows; and (vi) the Condensed Notes to Consolidated Financial Statements.*
|
|
|
|
PACIRA PHARMACEUTICALS, INC.
(REGISTRANT)
|
|
|
|
|
|
Dated:
|
November 8, 2017
|
/s/ DAVID STACK
|
|
|
|
David Stack
|
|
|
|
Chief Executive Officer and Chairman
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
Dated:
|
November 8, 2017
|
/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 |
|---|