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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, 2016
TABLE OF CONTENTS
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Page #
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PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
|
|||||||
|
|
June 30,
2016 |
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December 31,
2015 |
||||
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(Note 2)
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||||
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ASSETS
|
|
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|
|
|
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Current assets:
|
|
|
|
|
|
||
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Cash and cash equivalents
|
$
|
25,309
|
|
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$
|
56,984
|
|
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Short-term investments
|
137,358
|
|
|
101,981
|
|
||
|
Accounts receivable, net
|
28,651
|
|
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25,855
|
|
||
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Inventories, net
|
60,916
|
|
|
61,645
|
|
||
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Prepaid expenses and other current assets
|
5,755
|
|
|
6,117
|
|
||
|
Total current assets
|
257,989
|
|
|
252,582
|
|
||
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Long-term investments
|
—
|
|
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13,462
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|
||
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Fixed assets, net
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99,282
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|
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90,324
|
|
||
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Goodwill
|
42,751
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|
|
30,880
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|
||
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Intangible assets, net
|
—
|
|
|
81
|
|
||
|
Other assets
|
677
|
|
|
406
|
|
||
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Total assets
|
$
|
400,699
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|
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$
|
387,735
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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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Accounts payable
|
$
|
4,614
|
|
|
$
|
8,739
|
|
|
Accrued expenses
|
38,330
|
|
|
35,375
|
|
||
|
Convertible senior notes
|
106,388
|
|
|
104,040
|
|
||
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Current portion of deferred revenue
|
1,048
|
|
|
1,426
|
|
||
|
Income taxes payable
|
58
|
|
|
208
|
|
||
|
Total current liabilities
|
150,438
|
|
|
149,788
|
|
||
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Deferred revenue
|
7,747
|
|
|
8,082
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|
||
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Other liabilities
|
14,163
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|
|
11,473
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|
||
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Total liabilities
|
172,348
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|
|
169,343
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|
||
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Commitments and contingencies (Note 12)
|
|
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Stockholders’ equity:
|
|
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Preferred stock, par value $0.001; 5,000,000 shares authorized; none issued and outstanding at
June 30, 2016 and December 31, 2015 |
—
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—
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Common stock, par value $0.001, 250,000,000 shares authorized; 37,273,407 shares issued and
outstanding at June 30, 2016; 36,848,319 shares issued and outstanding at December 31, 2015 |
37
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37
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|
||
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Additional paid-in capital
|
548,277
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|
526,696
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|
||
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Accumulated deficit
|
(320,101
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)
|
|
(308,289
|
)
|
||
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Accumulated other comprehensive income (loss)
|
138
|
|
|
(52
|
)
|
||
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Total stockholders’ equity
|
228,351
|
|
|
218,392
|
|
||
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Total liabilities and stockholders’ equity
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$
|
400,699
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|
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$
|
387,735
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|
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PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
|
|||||||||||||||
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|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
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2016
|
|
2015
|
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2016
|
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2015
|
||||||||
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Revenues:
|
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||||
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Net product sales
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$
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67,687
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$
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58,062
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$
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132,189
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$
|
115,146
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Collaborative licensing and milestone revenue
|
1,356
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356
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|
|
1,713
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|
|
713
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|
||||
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Royalty revenue
|
597
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|
|
730
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|
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1,212
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1,604
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||||
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Total revenues
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69,640
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59,148
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135,114
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|
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117,463
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|
||||
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Operating expenses:
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||||
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Cost of goods sold
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23,053
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18,929
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43,331
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36,509
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|
||||
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Research and development
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9,362
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3,649
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18,855
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|
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9,616
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|
||||
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Selling, general and administrative
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43,669
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34,752
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|
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81,626
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|
|
66,180
|
|
||||
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Total operating expenses
|
76,084
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57,330
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|
|
143,812
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|
|
112,305
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|
||||
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Income (loss) from operations
|
(6,444
|
)
|
|
1,818
|
|
|
(8,698
|
)
|
|
5,158
|
|
||||
|
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
|
|
||||
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Interest income
|
324
|
|
|
177
|
|
|
576
|
|
|
332
|
|
||||
|
Interest expense
|
(1,733
|
)
|
|
(1,940
|
)
|
|
(3,601
|
)
|
|
(3,935
|
)
|
||||
|
Royalty interest obligation
|
—
|
|
|
—
|
|
|
—
|
|
|
(71
|
)
|
||||
|
Loss on early extinguishment of debt
|
—
|
|
|
(51
|
)
|
|
—
|
|
|
(51
|
)
|
||||
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Other, net
|
(47
|
)
|
|
43
|
|
|
1
|
|
|
(74
|
)
|
||||
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Total other expense, net
|
(1,456
|
)
|
|
(1,771
|
)
|
|
(3,024
|
)
|
|
(3,799
|
)
|
||||
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Income (loss) before income taxes
|
(7,900
|
)
|
|
47
|
|
|
(11,722
|
)
|
|
1,359
|
|
||||
|
Income tax expense
|
(58
|
)
|
|
(39
|
)
|
|
(90
|
)
|
|
(91
|
)
|
||||
|
Net income (loss)
|
$
|
(7,958
|
)
|
|
$
|
8
|
|
|
$
|
(11,812
|
)
|
|
$
|
1,268
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Net income (loss) per share:
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Basic and diluted net income (loss) per common share
|
$
|
(0.21
|
)
|
|
$
|
0.00
|
|
|
$
|
(0.32
|
)
|
|
$
|
0.03
|
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
||||||
|
Basic
|
37,181
|
|
|
36,481
|
|
|
37,101
|
|
|
36,358
|
|
||||
|
Diluted
|
37,181
|
|
|
41,445
|
|
|
37,101
|
|
|
41,612
|
|
||||
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(In thousands)
(Unaudited)
|
|||||||||||||||
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Net income (loss)
|
$
|
(7,958
|
)
|
|
$
|
8
|
|
|
$
|
(11,812
|
)
|
|
$
|
1,268
|
|
|
Other comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Net unrealized gain on investments
|
89
|
|
|
1
|
|
|
190
|
|
|
53
|
|
||||
|
Total other comprehensive income
|
89
|
|
|
1
|
|
|
190
|
|
|
53
|
|
||||
|
Comprehensive income (loss)
|
$
|
(7,869
|
)
|
|
$
|
9
|
|
|
$
|
(11,622
|
)
|
|
$
|
1,321
|
|
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
FOR THE SIX MONTHS ENDED JUNE 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
|
331
|
|
|
—
|
|
|
4,431
|
|
|
—
|
|
|
—
|
|
|
4,431
|
|
|||||
|
Vested restricted stock units
|
59
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
|
Shares issued under employee stock
purchase plan |
35
|
|
|
—
|
|
|
995
|
|
|
—
|
|
|
—
|
|
|
995
|
|
|||||
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
16,155
|
|
|
—
|
|
|
—
|
|
|
16,155
|
|
|||||
|
Net unrealized gain on investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
190
|
|
|
190
|
|
|||||
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(11,812
|
)
|
|
—
|
|
|
(11,812
|
)
|
|||||
|
Balances at June 30, 2016
|
37,273
|
|
|
$
|
37
|
|
|
$
|
548,277
|
|
|
$
|
(320,101
|
)
|
|
$
|
138
|
|
|
$
|
228,351
|
|
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
|
|||||||
|
|
Six Months Ended
June 30, |
||||||
|
|
2016
|
|
2015
|
||||
|
|
|
|
(Note 2)
|
||||
|
Operating activities:
|
|
|
|
|
|
||
|
Net income (loss)
|
$
|
(11,812
|
)
|
|
$
|
1,268
|
|
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
|
|
|
|
|
|
||
|
Depreciation of fixed assets and amortization of intangibles
|
6,381
|
|
|
5,526
|
|
||
|
Amortization of unfavorable lease obligation and debt issuance costs, net
|
240
|
|
|
241
|
|
||
|
Amortization of debt discount
|
2,044
|
|
|
2,058
|
|
||
|
Loss on early extinguishment of debt
|
—
|
|
|
51
|
|
||
|
Stock-based compensation
|
16,155
|
|
|
14,813
|
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
||
|
Restricted cash
|
—
|
|
|
1,509
|
|
||
|
Accounts receivable, net
|
(2,796
|
)
|
|
(1,915
|
)
|
||
|
Inventories, net
|
729
|
|
|
(19,506
|
)
|
||
|
Prepaid expenses and other assets
|
92
|
|
|
1,032
|
|
||
|
Accounts payable, accrued expenses and income taxes payable
|
(8,658
|
)
|
|
2,182
|
|
||
|
Royalty interest obligation
|
—
|
|
|
(276
|
)
|
||
|
Other liabilities
|
2,758
|
|
|
38
|
|
||
|
Deferred revenue
|
(713
|
)
|
|
(713
|
)
|
||
|
Net cash provided by operating activities
|
4,420
|
|
|
6,308
|
|
||
|
Investing activities:
|
|
|
|
|
|
||
|
Purchases of fixed assets
|
(15,921
|
)
|
|
(19,706
|
)
|
||
|
Purchases of investments
|
(121,790
|
)
|
|
(92,921
|
)
|
||
|
Sales of investments
|
100,065
|
|
|
98,179
|
|
||
|
Payment of contingent consideration
|
(3,871
|
)
|
|
(3,362
|
)
|
||
|
Net cash used in investing activities
|
(41,517
|
)
|
|
(17,810
|
)
|
||
|
Financing activities:
|
|
|
|
|
|
||
|
Proceeds from exercise of stock options
|
4,431
|
|
|
6,975
|
|
||
|
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
|
5,422
|
|
|
6,704
|
|
||
|
Net decrease in cash and cash equivalents
|
(31,675
|
)
|
|
(4,798
|
)
|
||
|
Cash and cash equivalents, beginning of period
|
56,984
|
|
|
37,520
|
|
||
|
Cash and cash equivalents, end of period
|
$
|
25,309
|
|
|
$
|
32,722
|
|
|
Supplemental cash flow information:
|
|
|
|
|
|
||
|
Cash paid for interest, including royalty interest obligation
|
$
|
1,926
|
|
|
$
|
2,297
|
|
|
Cash paid for income taxes, net of refunds
|
$
|
241
|
|
|
$
|
159
|
|
|
Non-cash investing and financing activities:
|
|
|
|
||||
|
Issuance of stock from conversion of convertible senior notes
|
$
|
—
|
|
|
$
|
3,930
|
|
|
Net (decrease) increase in accrued fixed assets
|
$
|
(662
|
)
|
|
$
|
4,150
|
|
|
Accrued payment of contingent consideration
|
$
|
(8,000
|
)
|
|
$
|
—
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
Largest customer
|
32%
|
|
32%
|
|
32%
|
|
31%
|
|
Second largest customer
|
27%
|
|
28%
|
|
28%
|
|
29%
|
|
Third largest customer
|
26%
|
|
27%
|
|
27%
|
|
27%
|
|
|
85%
|
|
87%
|
|
87%
|
|
87%
|
|
|
June 30,
|
|
December 31,
|
||||
|
|
2016
|
|
2015
|
||||
|
Raw materials
|
$
|
14,436
|
|
|
$
|
16,712
|
|
|
Work-in-process
|
1,965
|
|
|
12,152
|
|
||
|
Finished goods
|
44,515
|
|
|
32,781
|
|
||
|
Total
|
$
|
60,916
|
|
|
$
|
61,645
|
|
|
|
June 30,
|
|
December 31,
|
||||
|
|
2016
|
|
2015
|
||||
|
Machinery and laboratory equipment
|
$
|
32,362
|
|
|
$
|
29,864
|
|
|
Leasehold improvements
|
32,665
|
|
|
30,834
|
|
||
|
Computer equipment and software
|
5,296
|
|
|
4,007
|
|
||
|
Office furniture and equipment
|
1,606
|
|
|
1,439
|
|
||
|
Construction in progress
|
58,563
|
|
|
49,097
|
|
||
|
Total
|
130,492
|
|
|
115,241
|
|
||
|
Less: accumulated depreciation
|
(31,210
|
)
|
|
(24,917
|
)
|
||
|
Fixed assets, net
|
$
|
99,282
|
|
|
$
|
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 EXPAREL
|
8,000
|
|
|
|
Percentage payments on collections of net sales of EXPAREL
|
3,871
|
|
|
|
Balance at June 30, 2016
|
$
|
42,751
|
|
|
|
June 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
|
|
|
|
|
|
June 30,
|
|
December 31,
|
||||
|
|
2016
|
|
2015
|
||||
|
3.25% convertible senior notes
|
$
|
118,531
|
|
|
$
|
118,533
|
|
|
Deferred financing costs
|
(1,582
|
)
|
|
(1,888
|
)
|
||
|
Discount on debt
|
(10,561
|
)
|
|
(12,605
|
)
|
||
|
Total debt, net of debt discount
|
$
|
106,388
|
|
|
$
|
104,040
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Contractual interest expense
|
$
|
963
|
|
|
$
|
963
|
|
|
$
|
1,926
|
|
|
$
|
1,930
|
|
|
Amortization of debt issuance costs
|
153
|
|
|
153
|
|
|
306
|
|
|
308
|
|
||||
|
Amortization of debt discount
|
1,022
|
|
|
1,024
|
|
|
2,044
|
|
|
2,058
|
|
||||
|
Capitalized interest (Note 4)
|
(405
|
)
|
|
(200
|
)
|
|
(675
|
)
|
|
(361
|
)
|
||||
|
Total
|
$
|
1,733
|
|
|
$
|
1,940
|
|
|
$
|
3,601
|
|
|
$
|
3,935
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Effective interest rate on the Notes
|
7.22
|
%
|
|
7.20
|
%
|
|
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
|
||||||||||||
|
June 30, 2016
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|||||||||
|
3.25% convertible senior notes *
|
|
$
|
106,388
|
|
|
$
|
—
|
|
|
$
|
176,019
|
|
|
$
|
—
|
|
|
June 30, 2016 Debt Securities
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
(Level 2) |
||||||||
|
Short-term:
|
|
|
|
|
|
|
|
|
||||||||
|
Asset-backed securities
|
|
$
|
31,908
|
|
|
$
|
9
|
|
|
$
|
(1
|
)
|
|
$
|
31,916
|
|
|
Commercial paper
|
|
36,839
|
|
|
119
|
|
|
—
|
|
|
36,958
|
|
||||
|
Corporate bonds
|
|
68,473
|
|
|
29
|
|
|
(18
|
)
|
|
68,484
|
|
||||
|
Total
|
|
$
|
137,220
|
|
|
$
|
157
|
|
|
$
|
(19
|
)
|
|
$
|
137,358
|
|
|
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
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Cost of goods sold
|
|
$
|
1,610
|
|
|
$
|
1,586
|
|
|
$
|
3,159
|
|
|
$
|
2,689
|
|
|
Research and development
|
|
1,015
|
|
|
561
|
|
|
1,908
|
|
|
2,070
|
|
||||
|
Selling, general and administrative
|
|
5,040
|
|
|
5,149
|
|
|
11,088
|
|
|
10,054
|
|
||||
|
Total
|
|
$
|
7,665
|
|
|
$
|
7,296
|
|
|
$
|
16,155
|
|
|
$
|
14,813
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Stock-based compensation from:
|
|
|
|
|
|
|
|
|
||||||||
|
Stock options (employee awards)
|
|
$
|
5,789
|
|
|
$
|
6,739
|
|
|
$
|
12,633
|
|
|
$
|
13,049
|
|
|
Stock options (consultant awards)
|
|
437
|
|
|
(54
|
)
|
|
723
|
|
|
942
|
|
||||
|
Restricted stock units (employee awards)
|
|
1,140
|
|
|
369
|
|
|
2,225
|
|
|
369
|
|
||||
|
Employee stock purchase plan
|
|
299
|
|
|
242
|
|
|
574
|
|
|
453
|
|
||||
|
Total
|
|
$
|
7,665
|
|
|
$
|
7,296
|
|
|
$
|
16,155
|
|
|
$
|
14,813
|
|
|
Stock Options
|
|
Number of Options
|
|
Weighted Average Exercise Price
|
|||
|
Outstanding at December 31, 2015
|
|
4,645,722
|
|
|
$
|
44.03
|
|
|
Granted
|
|
741,003
|
|
|
44.68
|
|
|
|
Exercised
|
|
(331,272
|
)
|
|
13.39
|
|
|
|
Forfeited
|
|
(273,630
|
)
|
|
72.50
|
|
|
|
Expired
|
|
(119,848
|
)
|
|
81.26
|
|
|
|
Outstanding at June 30, 2016
|
|
4,661,975
|
|
|
43.68
|
|
|
|
Restricted Stock Units
|
|
Number of Units
|
|
Weighted Average Grant Date Fair Value
|
|||
|
Unvested at December 31, 2015
|
|
216,198
|
|
|
$
|
78.59
|
|
|
Granted
|
|
246,281
|
|
|
40.46
|
|
|
|
Vested
|
|
(59,111
|
)
|
|
79.33
|
|
|
|
Forfeited
|
|
(24,753
|
)
|
|
79.43
|
|
|
|
Unvested at June 30, 2016
|
|
378,615
|
|
|
53.56
|
|
|
|
|
Six Months Ended
June 30, |
||
|
|
2016
|
|
2015
|
|
Expected dividend yield
|
None
|
|
None
|
|
Risk free interest rate
|
1.21 - 1.85%
|
|
1.40 - 1.85%
|
|
Expected volatility
|
53.02%
|
|
53.28%
|
|
Expected term of options
|
5.75 years
|
|
5.75 years
|
|
|
|
Six Months Ended
June 30, |
||||||
|
Net unrealized gains (losses) from available for sale investments:
|
|
2016
|
|
2015
|
||||
|
Balance at beginning of period
|
|
$
|
(52
|
)
|
|
$
|
(80
|
)
|
|
Other comprehensive income before reclassifications
|
|
190
|
|
|
53
|
|
||
|
Amounts reclassified from accumulated other comprehensive income (loss)
|
|
—
|
|
|
—
|
|
||
|
Balance at end of period
|
|
$
|
138
|
|
|
$
|
(27
|
)
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|||||||||
|
Numerator:
|
|
|
|
|
|
|
|
||||||||
|
Net income (loss)
|
$
|
(7,958
|
)
|
|
$
|
8
|
|
|
$
|
(11,812
|
)
|
|
$
|
1,268
|
|
|
Denominator:
|
|
|
|
|
|
|
|
||||||||
|
Weighted average shares of common stock outstanding—basic
|
37,181
|
|
|
36,481
|
|
|
37,101
|
|
|
36,358
|
|
||||
|
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 ESPP
|
—
|
|
|
1
|
|
|
—
|
|
|
1
|
|
||||
|
Weighted average shares of common stock outstanding—diluted
|
37,181
|
|
|
41,445
|
|
|
37,101
|
|
|
41,612
|
|
||||
|
Net income (loss) per share:
|
|
|
|
|
|
|
|
||||||||
|
Basic and diluted net income (loss) per share of common stock
|
$
|
(0.21
|
)
|
|
$
|
0.00
|
|
|
$
|
(0.32
|
)
|
|
$
|
0.03
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||
|
Weighted average number of stock options
|
4,254
|
|
|
1,738
|
|
|
4,288
|
|
|
1,530
|
|
|
Weighted average number of RSUs
|
218
|
|
|
—
|
|
|
212
|
|
|
—
|
|
|
Conversion premium on the Notes
|
2,364
|
|
|
—
|
|
|
2,557
|
|
|
—
|
|
|
Weighted average number of warrants
|
—
|
|
|
—
|
|
|
1
|
|
|
—
|
|
|
Weighted average ESPP purchase options
|
—
|
|
|
—
|
|
|
12
|
|
|
—
|
|
|
Total
|
6,836
|
|
|
1,738
|
|
|
7,070
|
|
|
1,530
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Income (loss) before income taxes:
|
|
|
|
|
|
|
|
||||||||
|
Domestic
|
$
|
(7,526
|
)
|
|
$
|
352
|
|
|
$
|
(11,025
|
)
|
|
$
|
2,238
|
|
|
Foreign
|
(374
|
)
|
|
(305
|
)
|
|
(697
|
)
|
|
(879
|
)
|
||||
|
Total income (loss) before income taxes
|
$
|
(7,900
|
)
|
|
$
|
47
|
|
|
$
|
(11,722
|
)
|
|
$
|
1,359
|
|
|
Year
|
|
Aggregate Minimum Payments
|
||
|
2016 (remaining six months)
|
|
$
|
3,818
|
|
|
2017
|
|
7,878
|
|
|
|
2018
|
|
8,081
|
|
|
|
2019
|
|
8,303
|
|
|
|
2020
|
|
6,420
|
|
|
|
2021 through 2028
|
|
8,731
|
|
|
|
Total
|
|
$
|
43,231
|
|
|
•
|
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
$10.5 million
, or
18%
, in the three months ended
June 30, 2016
, compared to the same period in 2015, primarily driven by EXPAREL net product sales of
$65.8 million
, which were up
$8.8 million
, or
15%
. For the
six
months ended
June 30, 2016
, total revenues increased
$17.7 million
, or
15%
compared to the same period in 2015, again driven by EXPAREL net product sales of
$129.5 million
, up
$16.6 million
, or
15%
.
|
|
•
|
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, which will be paid in the third quarter of 2016.
|
|
•
|
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 termination fee based on a percentage of earned performance-based fees will be due to CrossLink. This fee, estimated to be approximately $7.2 million, is payable 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. We expect to complete enrollment for this trial by early 2017.
|
|
•
|
In April 2016, we announced the appointment of two key executives to the management team. Our new Chief Financial Officer, Charles A. Reinhart, III, was appointed effective May 3, 2016, and is responsible for all financial and capital market activities, including accounting, financial reporting, financial planning and analysis and investor relations. Our former Chief Financial Officer, James Scibetta, continues to serve as President. Our new Chief Commercial Officer, Robert Weiland, was appointed effective April 11, 2016 and oversees commercial activities for EXPAREL, which include marketing, sales, national accounts, training and commercial operations and analytics.
|
|
•
|
In February 2016, we announced topline results of an RCT using EXPAREL in third molar, or “wisdom teeth” extractions, with a per-protocol analysis demonstrating statistical significance and an intention-to-treat analysis strongly trending towards significance in spite of the underpowered study size resulting from one of three clinical sites being eliminated for protocol violations. We anticipate a late third quarter 2016 launch for EXPAREL in the oral maxillofacial market segment.
|
|
|
Three Months Ended
June 30, |
|
% Increase / (Decrease)
|
|
Six Months Ended
June 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2016
|
|
2015
|
|
|
2016
|
|
2015
|
|
||||||||||
|
Net product sales:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
EXPAREL
|
$
|
65,753
|
|
|
$
|
56,977
|
|
|
15%
|
|
$
|
129,505
|
|
|
$
|
112,927
|
|
|
15%
|
|
DepoCyt(e)
|
1,934
|
|
|
1,085
|
|
|
78%
|
|
2,684
|
|
|
2,219
|
|
|
21%
|
||||
|
Total net product sales
|
67,687
|
|
|
58,062
|
|
|
17%
|
|
132,189
|
|
|
115,146
|
|
|
15%
|
||||
|
Collaborative licensing and milestone revenue
|
1,356
|
|
|
356
|
|
|
281%
|
|
1,713
|
|
|
713
|
|
|
140%
|
||||
|
Royalty revenue
|
597
|
|
|
730
|
|
|
(18)%
|
|
1,212
|
|
|
1,604
|
|
|
(24)%
|
||||
|
Total revenues
|
$
|
69,640
|
|
|
$
|
59,148
|
|
|
18%
|
|
$
|
135,114
|
|
|
$
|
117,463
|
|
|
15%
|
|
|
Three Months Ended
June 30, |
|
% Increase / (Decrease)
|
|
Six Months Ended
June 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2016
|
|
2015
|
|
|
2016
|
|
2015
|
|
||||||||||
|
Cost of goods sold
|
$
|
23,053
|
|
|
$
|
18,929
|
|
|
22%
|
|
$
|
43,331
|
|
|
$
|
36,509
|
|
|
19%
|
|
Gross margin *
|
66
|
%
|
|
68
|
%
|
|
|
|
68
|
%
|
|
69
|
%
|
|
|
||||
|
|
Three Months Ended
June 30, |
|
% Increase / (Decrease)
|
|
Six Months Ended
June 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2016
|
|
2015
|
|
|
2016
|
|
2015
|
|
||||||||||
|
Clinical development
|
$
|
4,577
|
|
|
$
|
1,205
|
|
|
280%
|
|
$
|
8,911
|
|
|
$
|
3,162
|
|
|
182%
|
|
Product development and other
|
3,770
|
|
|
1,883
|
|
|
100%
|
|
8,036
|
|
|
4,384
|
|
|
83%
|
||||
|
Stock-based compensation
|
1,015
|
|
|
561
|
|
|
81%
|
|
1,908
|
|
|
2,070
|
|
|
(8)%
|
||||
|
Total research and development expense
|
$
|
9,362
|
|
|
$
|
3,649
|
|
|
157%
|
|
$
|
18,855
|
|
|
$
|
9,616
|
|
|
96%
|
|
% of total revenues
|
13
|
%
|
|
6
|
%
|
|
|
|
14
|
%
|
|
8
|
%
|
|
|
||||
|
|
Three Months Ended
June 30, |
|
% Increase / (Decrease)
|
|
Six Months Ended
June 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2016
|
|
2015
|
|
|
2016
|
|
2015
|
|
||||||||||
|
Sales and marketing
|
$
|
27,607
|
|
|
$
|
19,816
|
|
|
39%
|
|
$
|
47,946
|
|
|
$
|
37,988
|
|
|
26%
|
|
General and administrative
|
11,022
|
|
|
9,787
|
|
|
13%
|
|
22,592
|
|
|
18,138
|
|
|
25%
|
||||
|
Stock-based compensation
|
5,040
|
|
|
5,149
|
|
|
(2)%
|
|
11,088
|
|
|
10,054
|
|
|
10%
|
||||
|
Total selling, general and administrative expenses
|
$
|
43,669
|
|
|
$
|
34,752
|
|
|
26%
|
|
$
|
81,626
|
|
|
$
|
66,180
|
|
|
23%
|
|
% of total revenues
|
63
|
%
|
|
59
|
%
|
|
|
|
60
|
%
|
|
56
|
%
|
|
|
||||
|
|
Three Months Ended
June 30, |
|
% Increase / (Decrease)
|
|
Six Months Ended
June 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2016
|
|
2015
|
|
|
2016
|
|
2015
|
|
||||||||||
|
Interest income
|
$
|
324
|
|
|
$
|
177
|
|
|
83%
|
|
$
|
576
|
|
|
$
|
332
|
|
|
73%
|
|
Interest expense
|
(1,733
|
)
|
|
(1,940
|
)
|
|
(11)%
|
|
(3,601
|
)
|
|
(3,935
|
)
|
|
(8)%
|
||||
|
Royalty interest obligation
|
—
|
|
|
—
|
|
|
N/A
|
|
—
|
|
|
(71
|
)
|
|
(100)%
|
||||
|
Loss on extinguishment of debt
|
—
|
|
|
(51
|
)
|
|
(100)%
|
|
—
|
|
|
(51
|
)
|
|
(100)%
|
||||
|
Other, net
|
(47
|
)
|
|
43
|
|
|
N/A
|
|
1
|
|
|
(74
|
)
|
|
N/A
|
||||
|
Total other expense, net
|
(1,456
|
)
|
|
(1,771
|
)
|
|
(18)%
|
|
(3,024
|
)
|
|
(3,799
|
)
|
|
(20)%
|
||||
|
|
Three Months Ended
June 30, |
|
% Increase / (Decrease)
|
|
Six Months Ended
June 30, |
|
% Increase / (Decrease)
|
||||||||||||
|
|
|
|
|
||||||||||||||||
|
|
2016
|
|
2015
|
|
|
2016
|
|
2015
|
|
||||||||||
|
Income tax expense
|
$
|
58
|
|
|
$
|
39
|
|
|
49%
|
|
$
|
90
|
|
|
$
|
91
|
|
|
(1)%
|
|
Effective tax rate
|
(1
|
)%
|
|
83
|
%
|
|
|
|
(1
|
)%
|
|
7
|
%
|
|
|
||||
|
|
|
Six Months Ended
June 30, |
||||||
|
Consolidated Statement of Cash Flows Data:
|
|
2016
|
|
2015
|
||||
|
Net cash provided by (used in):
|
|
|
|
|
||||
|
Operating activities
|
|
$
|
4,420
|
|
|
$
|
6,308
|
|
|
Investing activities
|
|
(41,517
|
)
|
|
(17,810
|
)
|
||
|
Financing activities
|
|
5,422
|
|
|
6,704
|
|
||
|
Net decrease in cash and cash equivalents
|
|
$
|
(31,675
|
)
|
|
$
|
(4,798
|
)
|
|
•
|
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 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.
|
|
June 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
|
|
337
|
|
|
2,650
|
|
|
2,000
|
|
|
1,026
|
|
|
6,013
|
|
|||||
|
Payments/Credits
|
|
(534
|
)
|
|
(2,762
|
)
|
|
(2,175
|
)
|
|
(1,043
|
)
|
|
(6,514
|
)
|
|||||
|
Balance at June 30, 2016
|
|
$
|
1,536
|
|
|
$
|
513
|
|
|
$
|
570
|
|
|
$
|
780
|
|
|
$
|
3,399
|
|
|
June 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
|
|
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
|
|
|
Exhibit No.
|
|
Description
|
|
|
|
|
|
10.1 +
|
|
Executive Employment Agreement, dated May 2, 2016, between Pacira Pharmaceuticals, Inc. and Charles A. Reinhart, III.*
|
|
|
|
|
|
10.2 +
|
|
Amended and Restated 2011 Stock Incentive Plan. (1)
|
|
|
|
|
|
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 June 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:
|
August 4, 2016
|
/s/ DAVID STACK
|
|
|
|
David Stack
|
|
|
|
Chief Executive Officer and Chairman
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
Dated:
|
August 4, 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 |
|---|