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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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51-0619477
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(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer
Identification No.)
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Large accelerated filer
o
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Accelerated filer
x
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Non-accelerated filer
o
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Smaller reporting company
o
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(Do not check if a smaller reporting company)
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PACIRA PHARMACEUTICALS, INC.
TABLE OF CONTENTS
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Page
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26
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PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except share and per share amounts)
|
|||||||
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March 31,
2014 |
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December 31,
2013 |
||||
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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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18,762
|
|
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$
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12,515
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Restricted cash
|
—
|
|
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1,633
|
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||
Short-term investments
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45,811
|
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59,637
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Accounts receivable, net
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15,969
|
|
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14,590
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Inventories
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15,364
|
|
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15,557
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Prepaid expenses and other current assets
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2,572
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|
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2,819
|
|
||
Total current assets
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98,478
|
|
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106,751
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Fixed assets, net
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49,891
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48,182
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Goodwill
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11,327
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|
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10,328
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Intangibles, net
|
644
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|
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1,157
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Other assets
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3,353
|
|
|
3,402
|
|
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Total assets
|
$
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163,693
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$
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169,820
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LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
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Current liabilities:
|
|
|
|
|
|
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Accounts payable
|
$
|
2,605
|
|
|
$
|
3,069
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|
Accrued expenses
|
16,913
|
|
|
17,885
|
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Convertible senior notes
|
99,996
|
|
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98,961
|
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||
Current portion of royalty interest obligation
|
1,065
|
|
|
1,020
|
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Current portion of deferred revenue
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1,008
|
|
|
1,008
|
|
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Total current liabilities
|
121,587
|
|
|
121,943
|
|
||
Royalty interest obligation
|
—
|
|
|
226
|
|
||
Deferred revenue
|
2,960
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|
|
3,212
|
|
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Other liabilities
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3,435
|
|
|
3,190
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Total liabilities
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127,982
|
|
|
128,571
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Commitments and contingencies (Note 12)
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|
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Stockholders’ equity:
|
|
|
|
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Preferred stock, par value $0.001; 5,000,000 shares authorized, none issued and outstanding at
March 31, 2014 and December 31, 2013 |
—
|
|
|
—
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Common stock, par value $0.001, 250,000,000 shares authorized; 33,802,182 shares issued and
outstanding at March 31, 2014; 33,636,442 shares issued and outstanding at December 31, 2013 |
34
|
|
|
34
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Additional paid-in capital
|
343,578
|
|
|
337,639
|
|
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Accumulated deficit
|
(307,906
|
)
|
|
(296,429
|
)
|
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Accumulated other comprehensive income
|
5
|
|
|
5
|
|
||
Total stockholders’ equity
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35,711
|
|
|
41,249
|
|
||
Total liabilities and stockholders’ equity
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$
|
163,693
|
|
|
$
|
169,820
|
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PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except share and per share amounts)
|
|||||||
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Three Months Ended
March 31, |
||||||
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2014
|
|
2013
|
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Revenues:
|
|
|
|
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Net product sales
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$
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35,742
|
|
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$
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10,835
|
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Collaborative licensing and development revenue
|
252
|
|
|
243
|
|
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Royalty revenue
|
668
|
|
|
509
|
|
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Total revenues
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36,662
|
|
|
11,587
|
|
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Operating expenses:
|
|
|
|
|
|
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Cost of revenues
|
18,127
|
|
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11,391
|
|
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Research and development
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5,204
|
|
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5,905
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Selling, general and administrative
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22,589
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|
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12,936
|
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Total operating expenses
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45,920
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30,232
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Loss from operations
|
(9,258
|
)
|
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(18,645
|
)
|
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Other (expense) income:
|
|
|
|
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Interest income
|
42
|
|
|
73
|
|
||
Interest expense
|
(2,107
|
)
|
|
(1,519
|
)
|
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Loss on early extinguishment of debt
|
—
|
|
|
(3,398
|
)
|
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Royalty interest obligation
|
(120
|
)
|
|
(86
|
)
|
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Other, net
|
(34
|
)
|
|
(5
|
)
|
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Total other expense, net
|
(2,219
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)
|
|
(4,935
|
)
|
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Loss before income taxes
|
(11,477
|
)
|
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(23,580
|
)
|
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Income tax benefit
|
—
|
|
|
442
|
|
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Net loss
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$
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(11,477
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)
|
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$
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(23,138
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)
|
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Net loss per share:
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Basic and diluted net loss per common share
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$
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(0.34
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)
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$
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(0.71
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)
|
Weighted average common shares outstanding:
|
|
|
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Basic and diluted
|
33,710,970
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32,709,298
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PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
(In thousands)
|
|||||||
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Three Months Ended
March 31, |
||||||
|
2014
|
|
2013
|
||||
Net loss
|
$
|
(11,477
|
)
|
|
$
|
(23,138
|
)
|
Other comprehensive income:
|
|
|
|
|
|
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Net unrealized gain on investments
|
—
|
|
|
17
|
|
||
Total other comprehensive income
|
—
|
|
|
17
|
|
||
Comprehensive loss
|
$
|
(11,477
|
)
|
|
$
|
(23,121
|
)
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
For the Three Months Ended March 31, 2014
(Unaudited)
(In thousands)
|
||||||||||||||||||||||
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Common Stock
|
|
Additional
Paid-In Capital |
|
Accumulated
Deficit |
|
Accumulated
Other Comprehensive Income |
|
|
|||||||||||||
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Shares
|
|
Amount
|
|
|
|
|
Total
|
||||||||||||||
Balances at December 31, 2013
|
33,636
|
|
|
$
|
34
|
|
|
$
|
337,639
|
|
|
$
|
(296,429
|
)
|
|
$
|
5
|
|
|
$
|
41,249
|
|
Exercise of stock options
|
166
|
|
|
—
|
|
|
1,964
|
|
|
—
|
|
|
—
|
|
|
1,964
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
3,975
|
|
|
—
|
|
|
—
|
|
|
3,975
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(11,477
|
)
|
|
—
|
|
|
(11,477
|
)
|
|||||
Balances at March 31, 2014
|
33,802
|
|
|
$
|
34
|
|
|
$
|
343,578
|
|
|
$
|
(307,906
|
)
|
|
$
|
5
|
|
|
$
|
35,711
|
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
|
|||||||
|
Three Months Ended
March 31, |
||||||
|
2014
|
|
2013
|
||||
Operating activities:
|
|
|
|
|
|
||
Net loss
|
$
|
(11,477
|
)
|
|
$
|
(23,138
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||
Depreciation of fixed assets and amortization of intangibles
|
2,603
|
|
|
1,431
|
|
||
Amortization of unfavorable lease obligation and debt issuance costs
|
122
|
|
|
94
|
|
||
Amortization of debt discount
|
1,035
|
|
|
855
|
|
||
Loss on disposal of fixed assets
|
8
|
|
|
—
|
|
||
Loss on early extinguishment of debt
|
—
|
|
|
3,398
|
|
||
Stock-based compensation
|
3,975
|
|
|
2,225
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||
Restricted cash
|
1,633
|
|
|
1,523
|
|
||
Accounts receivable, net
|
(1,379
|
)
|
|
(891
|
)
|
||
Inventories
|
193
|
|
|
1,317
|
|
||
Prepaid expenses and other assets
|
237
|
|
|
(868
|
)
|
||
Accounts payable and accrued expenses
|
(1,531
|
)
|
|
162
|
|
||
Royalty interest obligation
|
(181
|
)
|
|
(104
|
)
|
||
Other liabilities
|
278
|
|
|
450
|
|
||
Deferred revenue
|
(252
|
)
|
|
(243
|
)
|
||
Net cash used in operating activities
|
(4,736
|
)
|
|
(13,789
|
)
|
||
Investing activities:
|
|
|
|
|
|
||
Purchases of fixed assets
|
(3,808
|
)
|
|
(2,932
|
)
|
||
Purchases of short-term investments
|
(18,946
|
)
|
|
(71,785
|
)
|
||
Sale of short-term investments
|
32,772
|
|
|
18,750
|
|
||
Payment of contingent consideration
|
(999
|
)
|
|
(284
|
)
|
||
Net cash provided by (used in) investing activities
|
9,019
|
|
|
(56,251
|
)
|
||
Financing activities:
|
|
|
|
|
|
||
Proceeds from exercise of stock options and warrants
|
1,964
|
|
|
877
|
|
||
Proceeds from convertible senior notes
|
—
|
|
|
120,000
|
|
||
Repayment of debt
|
—
|
|
|
(27,500
|
)
|
||
Payment of debt issuance and financing costs
|
—
|
|
|
(7,191
|
)
|
||
Net cash provided by financing activities
|
1,964
|
|
|
86,186
|
|
||
Net increase in cash and cash equivalents
|
6,247
|
|
|
16,146
|
|
||
Cash and cash equivalents, beginning of period
|
12,515
|
|
|
10,126
|
|
||
Cash and cash equivalents, end of period
|
$
|
18,762
|
|
|
$
|
26,272
|
|
Supplemental cash flow information
|
|
|
|
|
|
||
Cash paid for interest, including royalty interest obligation
|
$
|
2,251
|
|
|
$
|
584
|
|
Noncash investing and financing activities:
|
|
|
|
|
|
||
Equity component of convertible senior notes
|
$
|
—
|
|
|
$
|
24,936
|
|
|
Three Months Ended
|
||
|
March 31,
|
||
|
2014
|
|
2013
|
Largest customer
|
32%
|
|
34%
|
Second largest customer
|
29%
|
|
27%
|
Third largest customer
|
23%
|
|
16%
|
|
84%
|
|
77%
|
|
March 31,
|
|
December 31,
|
||||
|
2014
|
|
2013
|
||||
Raw materials
|
$
|
4,199
|
|
|
$
|
5,290
|
|
Work-in-process
|
7,757
|
|
|
6,321
|
|
||
Finished goods
|
3,408
|
|
|
3,946
|
|
||
Total
|
$
|
15,364
|
|
|
$
|
15,557
|
|
|
March 31,
|
|
December 31,
|
||||
|
2014
|
|
2013
|
||||
Machinery and laboratory equipment
|
$
|
23,141
|
|
|
$
|
19,570
|
|
Computer equipment and software
|
2,969
|
|
|
2,476
|
|
||
Office furniture and equipment
|
495
|
|
|
441
|
|
||
Leasehold improvements
|
26,337
|
|
|
24,852
|
|
||
Construction in progress
|
11,535
|
|
|
13,419
|
|
||
Total
|
64,477
|
|
|
60,758
|
|
||
Less accumulated depreciation
|
(14,586
|
)
|
|
(12,576
|
)
|
||
Fixed assets, net
|
$
|
49,891
|
|
|
$
|
48,182
|
|
(i)
|
$10.0 million
upon first commercial sale in the United States;
|
(ii)
|
$4.0 million
upon first commercial sale in a major EU country (United Kingdom, France, Germany, Italy and Spain);
|
(iii)
|
$8.0 million
when annual net sales collected reach
$100.0 million
;
|
(iv)
|
$8.0 million
when annual net sales collected reach
$250.0 million
; and
|
(v)
|
$32.0 million
when annual net sales collected reach
$500.0 million
.
|
Balance at December 31, 2013
|
$
|
10,328
|
|
Percentage payments on net sales of EXPAREL collected
|
999
|
|
|
Balance at March 31, 2014
|
$
|
11,327
|
|
March 31, 2014
|
|
Gross
Carrying Value |
|
Accumulated
Amortization |
|
Intangible
Assets, Net |
|
Estimated
Useful Life |
||||||
Amortizable intangible assets:
|
|
|
|
|
|
|
|
|
||||||
Core technology
|
|
$
|
2,900
|
|
|
$
|
(2,256
|
)
|
|
$
|
644
|
|
|
9 Years
|
Developed technology
|
|
11,700
|
|
|
(11,700
|
)
|
|
—
|
|
|
7 Years
|
|||
Trademarks and trade names
|
|
400
|
|
|
(400
|
)
|
|
—
|
|
|
7 Years
|
|||
Total intangible assets
|
|
$
|
15,000
|
|
|
$
|
(14,356
|
)
|
|
$
|
644
|
|
|
|
December 31, 2013
|
|
Gross
Carrying Value |
|
Accumulated
Amortization |
|
Intangible
Assets, Net |
|
Estimated
Useful Life |
||||||
Amortizable intangible assets:
|
|
|
|
|
|
|
|
|
||||||
Core technology
|
|
$
|
2,900
|
|
|
$
|
(2,175
|
)
|
|
$
|
725
|
|
|
9 Years
|
Developed technology
|
|
11,700
|
|
|
(11,282
|
)
|
|
418
|
|
|
7 Years
|
|||
Trademarks and trade names
|
|
400
|
|
|
(386
|
)
|
|
14
|
|
|
7 Years
|
|||
Total intangible assets
|
|
$
|
15,000
|
|
|
$
|
(13,843
|
)
|
|
$
|
1,157
|
|
|
|
|
Total
|
||
2014 (remaining nine months)
|
$
|
241
|
|
2015
|
322
|
|
|
2016
|
81
|
|
|
Total
|
$
|
644
|
|
|
March 31,
|
|
December 31,
|
||||
|
2014
|
|
2013
|
||||
Debt:
|
|
|
|
||||
Convertible senior notes
|
$
|
120,000
|
|
|
$
|
120,000
|
|
Discount on debt
|
(20,004
|
)
|
|
(21,039
|
)
|
||
Total debt, net of debt discount
|
99,996
|
|
|
98,961
|
|
||
Royalty interest obligation
|
1,065
|
|
|
1,246
|
|
||
Total debt and financing obligations
|
$
|
101,061
|
|
|
$
|
100,207
|
|
|
Three Months Ended,
|
||||||
|
March 31,
|
||||||
|
2014
|
|
2013
|
||||
Contractual interest expense
|
$
|
975
|
|
|
$
|
748
|
|
Amortization of debt issuance costs
|
155
|
|
|
119
|
|
||
Amortization of debt discount
|
1,035
|
|
|
793
|
|
||
|
$
|
2,165
|
|
|
$
|
1,660
|
|
|
|
|
|
|
|
||
Effective interest rate
|
7.22
|
%
|
|
7.22
|
%
|
•
|
Level 1—Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.
|
•
|
Level 2—Observable prices that are based on inputs not quoted on active markets, but corroborated by market data.
|
•
|
Level 3—Unobservable inputs that are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
|
|
|
|
|
Fair Value Measurements Using
|
||||||||||||
Financial Liabilities Carried at Historical Cost
|
|
Carrying Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
March 31, 2014
|
|
|
|
|
|
|
|
|
||||||||
Convertible senior notes *
|
|
$
|
99,996
|
|
|
$
|
—
|
|
|
$
|
343,674
|
|
|
$
|
—
|
|
|
|
|
|
Gross
|
|
Gross
|
|
|
||||||||
|
|
|
|
Unrealized
|
|
Unrealized
|
|
Fair Value
|
||||||||
March 31, 2014
|
|
Cost
|
|
Gains
|
|
Losses
|
|
(Level 2)
|
||||||||
Debt securities:
|
|
|
|
|
|
|
|
|
||||||||
Commercial paper
|
|
$
|
15,760
|
|
|
$
|
13
|
|
|
$
|
—
|
|
|
$
|
15,773
|
|
Corporate bonds
|
|
20,714
|
|
|
—
|
|
|
(6
|
)
|
|
20,708
|
|
||||
Asset-backed securities
|
|
9,332
|
|
|
—
|
|
|
(2
|
)
|
|
9,330
|
|
||||
Total
|
|
$
|
45,806
|
|
|
$
|
13
|
|
|
$
|
(8
|
)
|
|
$
|
45,811
|
|
|
|
|
|
Gross
|
|
Gross
|
|
|
||||||||
|
|
|
|
Unrealized
|
|
Unrealized
|
|
Fair Value
|
||||||||
December 31, 2013
|
|
Cost
|
|
Gains
|
|
Losses
|
|
(Level 2)
|
||||||||
Debt securities:
|
|
|
|
|
|
|
|
|
||||||||
Commercial paper
|
|
$
|
17,986
|
|
|
$
|
11
|
|
|
$
|
—
|
|
|
$
|
17,997
|
|
Corporate bonds
|
|
30,808
|
|
|
1
|
|
|
(7
|
)
|
|
30,802
|
|
||||
Asset-backed securities
|
|
10,838
|
|
|
1
|
|
|
(1
|
)
|
|
10,838
|
|
||||
Total
|
|
$
|
59,632
|
|
|
$
|
13
|
|
|
$
|
(8
|
)
|
|
$
|
59,637
|
|
|
Three Months Ended
|
||||||
|
March 31,
|
||||||
|
2014
|
|
2013
|
||||
Cost of revenues
|
$
|
494
|
|
|
$
|
235
|
|
Research and development
|
1,577
|
|
|
956
|
|
||
Selling, general and administrative
|
1,904
|
|
|
1,034
|
|
||
Total
|
$
|
3,975
|
|
|
$
|
2,225
|
|
Plan
|
|
Awards Reserved for Issuance
|
|
Awards Issued
|
|
Awards Available for Grant
|
|||
2011 Stock Incentive Plan
|
|
3,181,544
|
|
|
3,167,107
|
|
|
14,437
|
|
2007 Stock Incentive Plan
|
|
2,022,993
|
|
|
2,022,993
|
|
|
—
|
|
|
|
5,204,537
|
|
|
5,190,100
|
|
|
14,437
|
|
|
Number of Shares
|
|
Weighted Average Exercise Price
|
|||
Outstanding at December 31, 2013
|
3,840,038
|
|
|
$
|
13.50
|
|
Granted
|
193,225
|
|
|
64.82
|
|
|
Exercised
|
(165,740
|
)
|
|
11.85
|
|
|
Forfeited
|
(41,418
|
)
|
|
30.00
|
|
|
Expired
|
(22
|
)
|
|
12.57
|
|
|
Outstanding at March 31, 2014
|
3,826,083
|
|
|
$
|
15.99
|
|
|
Three Months Ended,
|
||||||
|
March 31,
|
||||||
|
2014
|
|
2013
|
||||
Net unrealized gains from available for sale investments:
|
|
|
|
||||
Balance at beginning of period
|
$
|
5
|
|
|
$
|
27
|
|
Other comprehensive income before reclassifications
|
—
|
|
|
17
|
|
||
Amounts reclassified from accumulated other comprehensive income
|
—
|
|
|
—
|
|
||
Balance at end of period
|
$
|
5
|
|
|
$
|
44
|
|
|
Three Months Ended
|
||||||
March 31,
|
|||||||
2014
|
|
2013
|
|||||
Numerator:
|
|
|
|
||||
Net loss
|
$
|
(11,477
|
)
|
|
$
|
(23,138
|
)
|
Denominator:
|
|
|
|
||||
Weighted average shares of common stock outstanding
|
33,711
|
|
|
32,709
|
|
||
Net loss per share:
|
|
|
|
||||
Basic and diluted net loss per share of common stock
|
$
|
(0.34
|
)
|
|
$
|
(0.71
|
)
|
|
Three Months Ended
March 31, 2014 |
|
Weighted average number of stock options outstanding
|
3,866
|
|
Conversion premium on the Notes
|
3,071
|
|
Weighted average number of warrants outstanding
|
58
|
|
Total
|
6,995
|
|
Year
|
|
|
||
2014 (remaining nine months)
|
|
$
|
3,728
|
|
2015
|
|
5,297
|
|
|
2016
|
|
5,436
|
|
|
2017
|
|
5,578
|
|
|
2018
|
|
5,725
|
|
|
2019 through 2028
|
|
15,899
|
|
|
Total
|
|
$
|
41,663
|
|
•
|
EXPAREL is a liposome injection of bupivacaine, an amide-type local anesthetic, indicated for administration into the surgical site to produce postsurgical analgesia and was approved by the FDA on October 28, 2011. We commercially launched EXPAREL in April 2012. We ship EXPAREL directly to the end user based on orders placed to wholesalers or directly to us and have no product held by wholesalers.
|
•
|
DepoCyt(e) is a sustained release liposomal formulation of the chemotherapeutic agent cytarabine and is indicated for the intrathecal treatment of lymphomatous meningitis. DepoCyt(e) was granted accelerated approval by the FDA in 1999 and full approval in 2007. We sell DepoCyt(e) to our commercial partners located in the U.S. and Europe.
|
•
|
Since the commercial launch of EXPAREL in April 2012, 2,452 accounts have ordered EXPAREL, 346 of which were added during the quarter ended March 31, 2014. The growing demand for EXPAREL is largely due to increasing acceptance by major hospitals and orthopedic centers as a result of its rapid adoption in orthopedic
|
•
|
Total revenues increased $25.1 million, or 216%, in the quarter ended March 31, 2014, as compared to the same period in 2013, primarily driven by EXPAREL product sales of $34.4 million, net of allowances for sales returns, prompt payment discounts, volume rebates, chargebacks and distribution service fees payable to wholesalers.
|
•
|
In February 2014, we announced that our Phase 3 clinical trial assessing the safety and efficacy of EXPAREL in femoral nerve block for total knee arthroplasty met its primary efficacy endpoint. We plan to submit data from the femoral nerve block study to demonstrate efficacy and safety, as well as safety data from the intercostal nerve block study, for a supplemental New Drug Application, which is anticipated in the second quarter of 2014.
|
•
|
In March 2014, the United States Food and Drug Administration, or FDA, approved an additional bulk manufacturing suite, or Suite C, for EXPAREL. The suite is located at our Science Center Campus in San Diego, California where EXPAREL is manufactured.
|
•
|
In April 2014, we and Patheon U.K. Limited, or Patheon, entered into a Strategic Co-Production Agreement, Technical Transfer and Service Agreement and Manufacturing Supply Agreement, or the Agreements, to collaborate in the manufacture and packaging of EXPAREL. Patheon has agreed to undertake certain technical transfer activities and construction services needed to prepare its Swindon, United Kingdom facility for the manufacture and packaging of EXPAREL in two dedicated manufacturing suites. We expect the first suite to begin commercial production in 2016 or 2017. We expect the expansion of our manufacturing capacity with Patheon coupled with our manufacturing facility at our Science Center Campus will enable us to meet the growing demand for EXPAREL.
|
•
|
In April 2014, we completed an underwritten public offering, selling 1,840,000 common shares at an offering price of $64.00 per share, which included the underwriters' exercise of the over-allotment option. Net proceeds received after underwriting fees and related expenses were approximately $110.4 million.
|
•
|
In April 2014, we and Mundipharma International Corporation Limited, or Mundipharma, amended our agreements to, among other things, (i) extend the term of such agreements by an additional 15 years to June 2033 and (ii) expand the territory where Mundipharma could market and distribute DepoCyte to South Africa and Turkey. We also granted Mundipharma exclusive marketing and distribution rights to DepoCyte in all countries other than the United States of America, Canada, Japan and those countries within which Mundipharma already markets DepoCyte. In connection with the agreements, we will receive a non-refundable upfront payment of $8.0 million.
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
||||||
|
March 31,
|
|
|||||||
|
2014
|
|
2013
|
|
|||||
Net product sales:
|
|
|
|
|
|
||||
EXPAREL
|
$
|
34,401
|
|
|
$
|
10,441
|
|
|
229%
|
DepoCyt(e)
|
1,341
|
|
|
394
|
|
|
240%
|
||
Total net product sales
|
35,742
|
|
|
10,835
|
|
|
230%
|
||
Collaborative licensing and development revenue
|
252
|
|
|
243
|
|
|
4%
|
||
Royalty revenue
|
668
|
|
|
509
|
|
|
31%
|
||
Total revenues
|
$
|
36,662
|
|
|
$
|
11,587
|
|
|
216%
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
||||||
|
March 31,
|
|
|||||||
|
2014
|
|
2013
|
|
|||||
Cost of goods sold
|
$
|
18,127
|
|
|
$
|
11,391
|
|
|
59%
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
||||||
|
March 31,
|
|
|||||||
|
2014
|
|
2013
|
|
|||||
Research and development expense
|
$
|
5,204
|
|
|
$
|
5,905
|
|
|
(12)%
|
•
|
Clinical development expenses decreased by $1.4 million relating to the conclusion of our Phase 3 pivotal trial of EXPAREL administered as an intercostal nerve block for thoracotomy in August 2013 and our Phase 2/3 pivotal trial of EXPAREL administered as a femoral nerve block for total knee arthroplasty in February 2014;
|
•
|
Pre-clinical expenses decreased by $0.6 million related to our toxicology studies;
|
•
|
Product development expenses increased by $0.6 million related to a potentially new manufacturing process for
EXPAREL; and
|
•
|
Stock-based compensation expense increased by $0.6 million.
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
||||||
|
March 31,
|
|
|||||||
|
2014
|
|
2013
|
|
|||||
General and administrative
|
$
|
7,431
|
|
|
$
|
4,675
|
|
|
59%
|
Sales and marketing
|
15,158
|
|
|
8,261
|
|
|
83%
|
||
Total selling, general and administrative expense
|
$
|
22,589
|
|
|
$
|
12,936
|
|
|
75%
|
•
|
General and administrative expenses increased by
$2.8
million primarily due to increases in salaries and benefits associated with our increased headcount to support the commercial and manufacturing growth of EXPAREL; and
|
•
|
Sales and marketing expenses increased by
$6.9
million primarily due to a $3.4 million increase in selling and promotional initiatives reflecting a larger sales force and expenditures for CrossLink, our third party distributor for the orthopedic and spine markets, and a $2.8 million increase in educational initiatives and programs to create product awareness in the orthopedic and soft tissue markets, as well as an increase in the number of our field-based medical health science personnel. Stock compensation expense also increased by $0.6 million.
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
||||||
|
March 31,
|
|
|||||||
|
2014
|
|
2013
|
|
|||||
Interest income
|
$
|
42
|
|
|
$
|
73
|
|
|
(42)%
|
Interest expense
|
(2,107
|
)
|
|
(1,519
|
)
|
|
39%
|
||
Loss on early extinguishment of debt
|
—
|
|
|
(3,398
|
)
|
|
(100)%
|
||
Royalty interest obligation
|
(120
|
)
|
|
(86
|
)
|
|
40%
|
||
Other, net
|
(34
|
)
|
|
(5
|
)
|
|
580%
|
||
Total other expense, net
|
$
|
(2,219
|
)
|
|
$
|
(4,935
|
)
|
|
(55)%
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
||||||
|
March 31,
|
|
|||||||
|
2014
|
|
2013
|
|
|||||
Income tax benefit
|
$
|
—
|
|
|
$
|
442
|
|
|
(100)%
|
|
Three Months Ended
|
||||||
|
March 31,
|
||||||
|
2014
|
|
2013
|
||||
Net cash provided by (used in):
|
|
|
|
||||
Operating activities
|
$
|
(4,736
|
)
|
|
$
|
(13,789
|
)
|
Investing activities
|
9,019
|
|
|
(56,251
|
)
|
||
Financing activities
|
1,964
|
|
|
86,186
|
|
||
Net increase in cash and cash equivalents
|
$
|
6,247
|
|
|
$
|
16,146
|
|
•
|
our ability to successfully continue our commercialization of EXPAREL;
|
•
|
the cost and timing of expanding our manufacturing facilities for EXPAREL and our other product candidates;
|
•
|
the costs of performing additional clinical trials for EXPAREL, including the pediatric trials required by the FDA as a condition of approval, and costs of development for our other product candidates;
|
•
|
the extent to which we acquire or invest in products, businesses and technologies; and
|
•
|
the extent to which the holders of our Notes elect to convert the Notes.
|
10.1
|
|
2014 Inducement Plan.*
|
|
|
|
31.1
|
|
Certification of President, Chief Executive Officer and Chairman pursuant to Rule 13a-14(a) and 15d-14(a), as amended.*
|
|
|
|
31.2
|
|
Certification of Senior Vice President and Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a), as amended.*
|
|
|
|
32.1
|
|
Certification of President, Chief Executive Officer and Chairman pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**
|
|
|
|
32.2
|
|
Certification of Senior Vice President and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**
|
|
|
|
101
|
|
The following materials from the Quarterly Report on Form 10-Q of Pacira Pharmaceuticals, Inc. for the quarter ended March 31, 2014, formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets, (ii) the Consolidated Statements of Operations, (iii) the Consolidated Statements of Comprehensive Loss, (iv) the Consolidated Statement of Stockholders’ Equity, (v) the Consolidated Statements of Cash Flows and (vi) the Condensed Notes to Consolidated Financial Statements.
|
|
|
PACIRA PHARMACEUTICALS, INC.
(REGISTRANT)
|
|
|
|
|
|
|
Dated:
|
May 1, 2014
|
/s/ DAVID STACK
|
|
|
David Stack
|
|
|
President, Chief Executive Officer and Chairman
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
Dated:
|
May 1, 2014
|
/s/ JAMES SCIBETTA
|
|
|
James Scibetta
|
|
|
Senior Vice President and Chief Financial Officer
|
|
|
(Principal Financial Officer)
|
1.
|
Purpose
|
2.
|
Eligibility
|
3.
|
Administration
|
4.
|
Stock Available for Awards
|
5.
|
Stock Options
|
6.
|
Stock Appreciation Rights
|
7.
|
Restricted Stock; Restricted Stock Units
|
8.
|
Other Stock-Based Awards
|
9.
|
Adjustments for Changes in Common Stock and Certain Other Events
|
10.
|
General Provisions Applicable to Awards
|
11.
|
Miscellaneous
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Pacira Pharmaceuticals, Inc. (the “Registrant”);
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;
|
4.
|
The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:
|
(a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and
|
5.
|
The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.
|
Date:
|
May 1, 2014
|
/s/ David Stack
|
|
|
David Stack
|
|
|
President, Chief Executive Officer and Chairman
|
|
|
(Principal Executive Officer)
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Pacira Pharmaceuticals, Inc. (the “Registrant”);
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;
|
4.
|
The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:
|
(a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and
|
5.
|
The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.
|
Date:
|
May 1, 2014
|
/s/ James Scibetta
|
|
|
James Scibetta
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Senior Vice President and Chief Financial Officer
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(Principal Financial Officer)
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Date:
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May 1, 2014
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/s/ David Stack
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David Stack
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President, Chief Executive Officer and Chairman
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(Principal Executive Officer)
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Date:
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May 1, 2014
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/s/ James Scibetta
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James Scibetta
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Senior Vice President and Chief Financial Officer
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(Principal Financial Officer)
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