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|
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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
|
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
|
||
(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
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)
|
|
|
PACIRA PHARMACEUTICALS, INC.
TABLE OF CONTENTS
|
||
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Page #
|
|
||
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PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except share and per share amounts)
|
|||||||
|
September 30,
2014 |
|
December 31,
2013 |
||||
|
|
|
(Note 2)
|
||||
ASSETS
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
17,756
|
|
|
$
|
12,515
|
|
Restricted cash
|
1,829
|
|
|
1,633
|
|
||
Short-term investments
|
131,972
|
|
|
59,637
|
|
||
Accounts receivable, net
|
20,517
|
|
|
14,590
|
|
||
Inventories
|
23,662
|
|
|
15,557
|
|
||
Prepaid expenses and other current assets
|
3,504
|
|
|
2,819
|
|
||
Total current assets
|
199,240
|
|
|
106,751
|
|
||
Long-term investments
|
24,527
|
|
|
—
|
|
||
Fixed assets, net
|
56,148
|
|
|
48,182
|
|
||
Goodwill
|
22,048
|
|
|
10,328
|
|
||
Intangibles, net
|
483
|
|
|
1,157
|
|
||
Other assets
|
2,948
|
|
|
3,402
|
|
||
Total assets
|
$
|
305,394
|
|
|
$
|
169,820
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
7,747
|
|
|
$
|
3,069
|
|
Accrued expenses
|
23,383
|
|
|
17,885
|
|
||
Convertible senior notes
|
102,065
|
|
|
98,961
|
|
||
Current portion of royalty interest obligation
|
602
|
|
|
1,020
|
|
||
Current portion of deferred revenue
|
1,426
|
|
|
1,008
|
|
||
Total current liabilities
|
135,223
|
|
|
121,943
|
|
||
Royalty interest obligation
|
—
|
|
|
226
|
|
||
Deferred revenue
|
9,864
|
|
|
3,212
|
|
||
Other liabilities
|
5,235
|
|
|
3,190
|
|
||
Total liabilities
|
150,322
|
|
|
128,571
|
|
||
Commitments and contingencies (Note 12)
|
|
|
|
|
|
||
Stockholders’ equity:
|
|
|
|
|
|
||
Preferred stock, par value $0.001; 5,000,000 shares authorized, none issued and outstanding at
September 30, 2014 and December 31, 2013 |
—
|
|
|
—
|
|
||
Common stock, par value $0.001, 250,000,000 shares authorized; 36,021,855 shares issued and
outstanding at September 30, 2014; 33,636,442 shares issued and outstanding at December 31, 2013 |
36
|
|
|
34
|
|
||
Additional paid-in capital
|
470,975
|
|
|
337,639
|
|
||
Accumulated deficit
|
(315,947
|
)
|
|
(296,429
|
)
|
||
Accumulated other comprehensive income
|
8
|
|
|
5
|
|
||
Total stockholders’ equity
|
155,072
|
|
|
41,249
|
|
||
Total liabilities and stockholders’ equity
|
$
|
305,394
|
|
|
$
|
169,820
|
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share amounts)
|
|||||||||||||||
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
September 30,
|
|
September 30,
|
||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net product sales
|
$
|
50,920
|
|
|
$
|
22,408
|
|
|
$
|
132,697
|
|
|
$
|
49,520
|
|
Collaborative licensing and development revenue
|
357
|
|
|
243
|
|
|
930
|
|
|
729
|
|
||||
Royalty revenue
|
771
|
|
|
608
|
|
|
2,249
|
|
|
1,737
|
|
||||
Total revenues
|
52,048
|
|
|
23,259
|
|
|
135,876
|
|
|
51,986
|
|
||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of goods sold
|
20,391
|
|
|
14,791
|
|
|
58,472
|
|
|
36,396
|
|
||||
Research and development
|
4,425
|
|
|
5,962
|
|
|
14,844
|
|
|
16,724
|
|
||||
Selling, general and administrative
|
28,217
|
|
|
15,320
|
|
|
75,643
|
|
|
42,336
|
|
||||
Total operating expenses
|
53,033
|
|
|
36,073
|
|
|
148,959
|
|
|
95,456
|
|
||||
Loss from operations
|
(985
|
)
|
|
(12,814
|
)
|
|
(13,083
|
)
|
|
(43,470
|
)
|
||||
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income
|
134
|
|
|
62
|
|
|
237
|
|
|
207
|
|
||||
Interest expense
|
(2,037
|
)
|
|
(1,892
|
)
|
|
(6,222
|
)
|
|
(5,325
|
)
|
||||
Loss on early extinguishment of debt
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,398
|
)
|
||||
Royalty interest obligation
|
(73
|
)
|
|
(132
|
)
|
|
(330
|
)
|
|
(379
|
)
|
||||
Other, net
|
(43
|
)
|
|
(8
|
)
|
|
(120
|
)
|
|
(30
|
)
|
||||
Total other expense, net
|
(2,019
|
)
|
|
(1,970
|
)
|
|
(6,435
|
)
|
|
(8,925
|
)
|
||||
Loss before income taxes
|
(3,004
|
)
|
|
(14,784
|
)
|
|
(19,518
|
)
|
|
(52,395
|
)
|
||||
Income tax benefit
|
—
|
|
|
—
|
|
|
—
|
|
|
442
|
|
||||
Net loss
|
$
|
(3,004
|
)
|
|
$
|
(14,784
|
)
|
|
$
|
(19,518
|
)
|
|
$
|
(51,953
|
)
|
|
|
|
|
|
|
|
|
||||||||
Net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted net loss per common share
|
$
|
(0.08
|
)
|
|
$
|
(0.44
|
)
|
|
$
|
(0.56
|
)
|
|
$
|
(1.57
|
)
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted
|
35,943
|
|
|
33,360
|
|
|
35,039
|
|
|
33,051
|
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
(In thousands)
|
|||||||||||||||
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
September 30,
|
|
September 30,
|
||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
Net loss
|
$
|
(3,004
|
)
|
|
$
|
(14,784
|
)
|
|
$
|
(19,518
|
)
|
|
$
|
(51,953
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net unrealized gain (loss) on investments
|
39
|
|
|
3
|
|
|
3
|
|
|
(10
|
)
|
||||
Total other comprehensive income (loss)
|
39
|
|
|
3
|
|
|
3
|
|
|
(10
|
)
|
||||
Comprehensive loss
|
$
|
(2,965
|
)
|
|
$
|
(14,781
|
)
|
|
$
|
(19,515
|
)
|
|
$
|
(51,963
|
)
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
For the Nine Months Ended September 30, 2014
(Unaudited)
(In thousands)
|
||||||||||||||||||||||
|
Common Stock
|
|
Additional
Paid-In Capital |
|
Accumulated
Deficit |
|
Accumulated
Other Comprehensive Income |
|
|
|||||||||||||
|
Shares
|
|
Amount
|
|
|
|
|
Total
|
||||||||||||||
Balances at December 31, 2013
|
33,636
|
|
|
$
|
34
|
|
|
$
|
337,639
|
|
|
$
|
(296,429
|
)
|
|
$
|
5
|
|
|
$
|
41,249
|
|
Follow-on public offering, net
|
1,840
|
|
|
2
|
|
|
110,405
|
|
|
—
|
|
|
—
|
|
|
110,407
|
|
|||||
Exercise of stock options
|
511
|
|
|
—
|
|
|
5,732
|
|
|
—
|
|
|
—
|
|
|
5,732
|
|
|||||
Cashless exercise of warrants
|
35
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
17,199
|
|
|
—
|
|
|
—
|
|
|
17,199
|
|
|||||
Net unrealized gain on investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3
|
|
|
3
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(19,518
|
)
|
|
—
|
|
|
(19,518
|
)
|
|||||
Balances at September 30, 2014
|
36,022
|
|
|
$
|
36
|
|
|
$
|
470,975
|
|
|
$
|
(315,947
|
)
|
|
$
|
8
|
|
|
$
|
155,072
|
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
|
|||||||
|
Nine Months Ended
|
||||||
|
September 30,
|
||||||
|
2014
|
|
2013
|
||||
Operating activities:
|
|
|
|
|
|
||
Net loss
|
$
|
(19,518
|
)
|
|
$
|
(51,953
|
)
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
|
|
|
|
|
|
||
Depreciation of fixed assets and amortization of intangibles
|
7,328
|
|
|
4,047
|
|
||
Amortization of unfavorable lease obligation and debt issuance costs
|
365
|
|
|
337
|
|
||
Amortization of debt discount
|
3,104
|
|
|
2,924
|
|
||
Loss on disposal of fixed assets
|
157
|
|
|
31
|
|
||
Loss on early extinguishment of debt
|
—
|
|
|
3,398
|
|
||
Stock-based compensation
|
17,199
|
|
|
8,227
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||
Restricted cash
|
(196
|
)
|
|
(452
|
)
|
||
Accounts receivable, net
|
(5,927
|
)
|
|
(5,419
|
)
|
||
Inventories
|
(8,105
|
)
|
|
(3,529
|
)
|
||
Prepaid expenses and other assets
|
(696
|
)
|
|
(638
|
)
|
||
Accounts payable and accrued expenses
|
10,176
|
|
|
6,421
|
|
||
Royalty interest obligation
|
(641
|
)
|
|
(336
|
)
|
||
Other liabilities
|
2,142
|
|
|
735
|
|
||
Deferred revenue
|
7,070
|
|
|
(729
|
)
|
||
Net cash provided by (used in) operating activities
|
12,458
|
|
|
(36,936
|
)
|
||
Investing activities:
|
|
|
|
|
|
||
Purchases of fixed assets
|
(14,777
|
)
|
|
(9,368
|
)
|
||
Purchases of short-term investments
|
(140,410
|
)
|
|
(102,114
|
)
|
||
Sales of short-term investments
|
68,016
|
|
|
54,564
|
|
||
Purchases of long-term investments
|
(24,465
|
)
|
|
—
|
|
||
Payment of contingent consideration
|
(11,720
|
)
|
|
(1,241
|
)
|
||
Net cash used in investing activities
|
(123,356
|
)
|
|
(58,159
|
)
|
||
Financing activities:
|
|
|
|
|
|
||
Proceeds from follow-on public offering, net
|
110,407
|
|
|
—
|
|
||
Proceeds from exercise of stock options and warrants
|
5,732
|
|
|
3,043
|
|
||
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
|
116,139
|
|
|
88,352
|
|
||
Net increase (decrease) in cash and cash equivalents
|
5,241
|
|
|
(6,743
|
)
|
||
Cash and cash equivalents, beginning of period
|
12,515
|
|
|
10,126
|
|
||
Cash and cash equivalents, end of period
|
$
|
17,756
|
|
|
$
|
3,383
|
|
Supplemental cash flow information:
|
|
|
|
|
|
||
Cash paid for interest, including royalty interest obligation
|
$
|
4,873
|
|
|
$
|
3,157
|
|
Non-cash investing and financing activities:
|
|
|
|
|
|
||
Equity component of convertible senior notes
|
$
|
—
|
|
|
$
|
24,936
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||
|
September 30,
|
|
September 30,
|
||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
Largest customer
|
34%
|
|
32%
|
|
33%
|
|
33%
|
Second largest customer
|
29%
|
|
27%
|
|
29%
|
|
27%
|
Third largest customer
|
24%
|
|
18%
|
|
23%
|
|
17%
|
|
87%
|
|
77%
|
|
85%
|
|
77%
|
|
September 30,
|
|
December 31,
|
||||
|
2014
|
|
2013
|
||||
Raw materials
|
$
|
8,944
|
|
|
$
|
5,290
|
|
Work-in-process
|
10,398
|
|
|
6,321
|
|
||
Finished goods
|
4,320
|
|
|
3,946
|
|
||
Total
|
$
|
23,662
|
|
|
$
|
15,557
|
|
|
September 30,
|
|
December 31,
|
||||
|
2014
|
|
2013
|
||||
Machinery and laboratory equipment
|
$
|
23,274
|
|
|
$
|
19,570
|
|
Computer equipment and software
|
3,465
|
|
|
2,476
|
|
||
Office furniture and equipment
|
954
|
|
|
441
|
|
||
Leasehold improvements
|
26,210
|
|
|
24,852
|
|
||
Construction in progress
|
19,736
|
|
|
13,419
|
|
||
Total
|
73,639
|
|
|
60,758
|
|
||
Less: accumulated depreciation
|
(17,491
|
)
|
|
(12,576
|
)
|
||
Fixed assets, net
|
$
|
56,148
|
|
|
$
|
48,182
|
|
(i)
|
$10.0 million
upon the first commercial sale in the United States;
|
(ii)
|
$4.0 million
upon the first commercial sale in a major EU country (United Kingdom, France, Germany, Italy and Spain);
|
(iii)
|
$8.0 million
when annual net sales collected reach
$100.0 million
;
|
(iv)
|
$8.0 million
when annual net sales collected reach
$250.0 million
; and
|
(v)
|
$32.0 million
when annual net sales collected reach
$500.0 million
.
|
|
|
Carrying Value
|
||
Balance at December 31, 2013
|
|
$
|
10,328
|
|
Milestone payments triggered by collections of net sales of EXPAREL
|
|
8,000
|
|
|
Percentage payments on collections of net sales of EXPAREL
|
|
3,720
|
|
|
Balance at September 30, 2014
|
|
$
|
22,048
|
|
September 30, 2014
|
|
Gross
Carrying Value |
|
Accumulated
Amortization |
|
Intangible
Assets, Net |
|
Estimated
Useful Life |
||||||
Amortizable intangible assets:
|
|
|
|
|
|
|
|
|
||||||
Core technology
|
|
$
|
2,900
|
|
|
$
|
(2,417
|
)
|
|
$
|
483
|
|
|
9 Years
|
Developed technology
|
|
11,700
|
|
|
(11,700
|
)
|
|
—
|
|
|
7 Years
|
|||
Trademarks and trade names
|
|
400
|
|
|
(400
|
)
|
|
—
|
|
|
7 Years
|
|||
Total intangible assets
|
|
$
|
15,000
|
|
|
$
|
(14,517
|
)
|
|
$
|
483
|
|
|
|
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
|
|
|
|
Year
|
|
Total
|
||
2014 (remaining three months)
|
|
$
|
80
|
|
2015
|
|
322
|
|
|
2016
|
|
81
|
|
|
Total
|
|
$
|
483
|
|
|
September 30,
|
|
December 31,
|
||||
|
2014
|
|
2013
|
||||
Debt:
|
|
|
|
||||
Convertible senior notes
|
$
|
120,000
|
|
|
$
|
120,000
|
|
Discount on debt
|
(17,935
|
)
|
|
(21,039
|
)
|
||
Total debt, net of debt discount
|
102,065
|
|
|
98,961
|
|
||
Royalty interest obligation
|
602
|
|
|
1,246
|
|
||
Total debt and financing obligations
|
$
|
102,667
|
|
|
$
|
100,207
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
September 30,
|
|
September 30,
|
||||||||||||
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
Contractual interest expense
|
$
|
975
|
|
|
$
|
975
|
|
|
$
|
2,925
|
|
|
$
|
2,687
|
|
Amortization of debt issuance costs
|
155
|
|
|
155
|
|
|
465
|
|
|
429
|
|
||||
Amortization of debt discount
|
1,035
|
|
|
1,035
|
|
|
3,104
|
|
|
2,863
|
|
||||
Total
|
$
|
2,165
|
|
|
$
|
2,165
|
|
|
$
|
6,494
|
|
|
$
|
5,979
|
|
|
|
|
|
|
|
|
|
||||||||
Effective interest rate
|
7.22
|
%
|
|
7.22
|
%
|
|
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.
|
|
|
Carrying Value
|
|
Fair Value Measurements Using
|
||||||||||||
Financial Liabilities Carried at Historical Cost
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|||||||||
September 30, 2014
|
|
|
|
|
|
|
|
|
||||||||
Convertible senior notes *
|
|
$
|
102,065
|
|
|
$
|
—
|
|
|
$
|
468,972
|
|
|
$
|
—
|
|
September 30, 2014
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
(Level 2) |
||||||||
Debt securities:
|
|
|
|
|
|
|
|
|
||||||||
Short-term:
|
|
|
|
|
|
|
|
|
||||||||
Asset-backed securities
|
|
$
|
15,013
|
|
|
$
|
—
|
|
|
$
|
(5
|
)
|
|
$
|
15,008
|
|
Commercial paper
|
|
5,744
|
|
|
6
|
|
|
—
|
|
|
5,750
|
|
||||
Corporate bonds
|
|
111,269
|
|
|
6
|
|
|
(61
|
)
|
|
111,214
|
|
||||
Subtotal
|
|
132,026
|
|
|
12
|
|
|
(66
|
)
|
|
131,972
|
|
||||
Long-term:
|
|
|
|
|
|
|
|
|
||||||||
Corporate bonds
|
|
24,465
|
|
|
70
|
|
|
(8
|
)
|
|
24,527
|
|
||||
Total
|
|
$
|
156,491
|
|
|
$
|
82
|
|
|
$
|
(74
|
)
|
|
$
|
156,499
|
|
December 31, 2013
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
(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
|
|
Nine Months Ended
|
||||||||||||
|
|
September 30,
|
|
September 30,
|
||||||||||||
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
||||||||
Cost of goods sold
|
|
$
|
1,187
|
|
|
$
|
414
|
|
|
$
|
2,323
|
|
|
$
|
1,041
|
|
Research and development
|
|
1,823
|
|
|
1,660
|
|
|
5,537
|
|
|
3,124
|
|
||||
Selling, general and administrative
|
|
4,676
|
|
|
1,703
|
|
|
9,339
|
|
|
4,062
|
|
||||
Total
|
|
$
|
7,686
|
|
|
$
|
3,777
|
|
|
$
|
17,199
|
|
|
$
|
8,227
|
|
|
|
|
|
|
|
|
|
|
||||||||
Stock-based compensation from:
|
|
|
|
|
|
|
|
|
||||||||
Stock options
|
|
$
|
7,579
|
|
|
$
|
3,777
|
|
|
$
|
17,092
|
|
|
$
|
8,227
|
|
Employee stock purchase plan
|
|
107
|
|
|
—
|
|
|
107
|
|
|
—
|
|
||||
Total
|
|
$
|
7,686
|
|
|
$
|
3,777
|
|
|
$
|
17,199
|
|
|
$
|
8,227
|
|
Stock Incentive Plan
|
|
Awards Reserved for Issuance
|
|
Awards Issued
|
|
Awards Available for Grant
|
|||
2007 Stock Incentive Plan
|
|
2,022,837
|
|
|
2,022,837
|
|
|
—
|
|
Amended and Restated 2011 Stock Incentive Plan
|
|
5,931,700
|
|
|
4,365,865
|
|
|
1,565,835
|
|
2014 Inducement Plan
|
|
175,000
|
|
|
77,000
|
|
|
98,000
|
|
|
|
8,129,537
|
|
|
6,465,702
|
|
|
1,663,835
|
|
Employee Stock Purchase Plan
|
|
Shares Reserved for Purchase
|
|
Shares Purchased
|
|
Shares Available for Purchase
|
|||
2014 Employee Stock Purchase Plan
|
|
500,000
|
|
|
—
|
|
|
500,000
|
|
Stock Options
|
|
Number of Shares
|
|
Weighted Average Exercise Price
|
|||
Outstanding at December 31, 2013
|
|
3,840,038
|
|
|
$
|
13.50
|
|
Granted
|
|
1,559,525
|
|
|
79.00
|
|
|
Exercised
|
|
(511,186
|
)
|
|
11.22
|
|
|
Forfeited
|
|
(131,577
|
)
|
|
40.98
|
|
|
Expired
|
|
(561
|
)
|
|
21.70
|
|
|
Outstanding at September 30, 2014
|
|
4,756,239
|
|
|
34.46
|
|
|
|
Nine Months Ended
|
||||||
|
|
September 30,
|
||||||
|
|
2014
|
|
2013
|
||||
Net unrealized gains (losses) from available for sale investments:
|
|
|
|
|
||||
Balance at beginning of period
|
|
$
|
5
|
|
|
$
|
27
|
|
Other comprehensive gain (loss) before reclassifications
|
|
3
|
|
|
(10
|
)
|
||
Amounts reclassified from accumulated other comprehensive income
|
|
—
|
|
|
—
|
|
||
Balance at end of period
|
|
$
|
8
|
|
|
$
|
17
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
September 30,
|
|
September 30,
|
|||||||||||||
2014
|
|
2013
|
|
2014
|
|
2013
|
|||||||||
Numerator:
|
|
|
|
|
|
|
|
||||||||
Net loss
|
$
|
(3,004
|
)
|
|
$
|
(14,784
|
)
|
|
$
|
(19,518
|
)
|
|
$
|
(51,953
|
)
|
Denominator:
|
|
|
|
|
|
|
|
||||||||
Weighted average shares of common stock outstanding
|
35,943
|
|
|
33,360
|
|
|
35,039
|
|
|
33,051
|
|
||||
Net loss per share:
|
|
|
|
|
|
|
|
||||||||
Basic and diluted net loss per share of common stock
|
$
|
(0.08
|
)
|
|
$
|
(0.44
|
)
|
|
$
|
(0.56
|
)
|
|
$
|
(1.57
|
)
|
|
Three Months Ended September 30, 2014
|
|
Nine Months Ended September 30, 2014
|
||
Weighted average number of stock options outstanding
|
4,842
|
|
|
4,285
|
|
Conversion premium on the Notes
|
3,602
|
|
|
3,311
|
|
Weighted average number of warrants outstanding
|
17
|
|
|
40
|
|
Employee stock purchase plan
|
6
|
|
|
2
|
|
Total
|
8,467
|
|
|
7,638
|
|
Year
|
|
|
||
2014 (remaining three months)
|
|
$
|
1,244
|
|
2015
|
|
5,297
|
|
|
2016
|
|
5,436
|
|
|
2017
|
|
5,578
|
|
|
2018
|
|
5,725
|
|
|
2019 through 2028
|
|
15,965
|
|
|
Total
|
|
$
|
39,245
|
|
•
|
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 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.
|
•
|
Since the commercial launch of EXPAREL in April 2012, 3,062 accounts have ordered EXPAREL, 247 of which were added during the quarter ended
September 30, 2014
. The growing demand for EXPAREL is largely due to growth within existing accounts and increasing acceptance by major hospitals and orthopedic centers as a result of continued adoption in soft tissue procedures as well as the rapid adoption of EXPAREL in orthopedic procedures.
|
•
|
Total revenues increased
$28.8 million
, or
124%
, in the quarter ended
September 30, 2014
, as compared to the same period in 2013, primarily driven by EXPAREL product sales of
$50.2 million
.
|
•
|
In September 2014, we received a warning letter from the FDA asserting that certain of our educational materials improperly suggest the use of EXPAREL for off-label uses that have not been approved by the FDA, and that one of our promotional advertisements violates FDA requirements by overstating the efficacy of EXPAREL. We responded to the FDA promptly in order to address the concerns raised in the warning letter. We are working with the FDA on a comprehensive plan of action.
|
•
|
In September 2014, we made an $8.0 million milestone payment to Skyepharma Holding, Inc., or Skyepharma, in connection with achieving $100.0 million of EXPAREL net sales collected.
|
•
|
In May 2014, we announced the submission of an sNDA for a nerve block indication based on data from a Phase 3 study demonstrating the efficacy and safety of EXPAREL in femoral nerve block for total knee arthroplasty, as well as data from a Phase 3 study in intercostal nerve block for thoracotomy. The FDA has accepted our sNDA for review and has set a Prescription Drug User Fee Act action date of March 5, 2015.
|
•
|
In April 2014, we and Patheon entered into a Strategic Co-Production Agreement, Technical Transfer and Service Agreement and Manufacturing Supply Agreement 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 the second half of 2016 and the second suite to become operational in the 2018 or 2019 timeframe. We expect that 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 a follow-on underwritten public offering, selling 1,840,000 shares of common stock, which included the underwriters’ exercise of the over-allotment option, at an offering price of $64.00 per share. We received net proceeds after underwriting fees and related expenses of $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 can market and distribute DepoCyte to all countries other than the United States of America, Canada and Japan. In connection with the agreements, we received a non-refundable upfront payment of $8.0 million from Mundipharma. The revenue has been deferred and will be recognized over the remaining contractual term.
|
•
|
In March 2014, the FDA approved an additional bulk manufacturing suite, or Suite C, for EXPAREL at our Science Center Campus in San Diego, California, which will more than double our manufacturing capacity.
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
|
Nine Months Ended
|
|
% Increase / (Decrease)
|
||||||||||||
|
September 30,
|
|
|
September 30,
|
|
||||||||||||||
|
2014
|
|
2013
|
|
|
2014
|
|
2013
|
|
||||||||||
Net product sales:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
EXPAREL
|
$
|
50,219
|
|
|
$
|
20,018
|
|
|
151%
|
|
$
|
129,535
|
|
|
$
|
45,683
|
|
|
184%
|
DepoCyt(e)
|
701
|
|
|
2,390
|
|
|
(71)%
|
|
3,162
|
|
|
3,837
|
|
|
(18)%
|
||||
Total net product sales
|
50,920
|
|
|
22,408
|
|
|
127%
|
|
132,697
|
|
|
49,520
|
|
|
168%
|
||||
Collaborative licensing and development revenue
|
357
|
|
|
243
|
|
|
47%
|
|
930
|
|
|
729
|
|
|
28%
|
||||
Royalty revenue
|
771
|
|
|
608
|
|
|
27%
|
|
2,249
|
|
|
1,737
|
|
|
29%
|
||||
Total revenues
|
$
|
52,048
|
|
|
$
|
23,259
|
|
|
124%
|
|
$
|
135,876
|
|
|
$
|
51,986
|
|
|
161%
|
|
Three Months Ended
|
|
% Increase
|
|
Nine Months Ended
|
|
% Increase
|
||||||||||||
|
September 30,
|
|
|
September 30,
|
|
||||||||||||||
|
2014
|
|
2013
|
|
|
2014
|
|
2013
|
|
||||||||||
Cost of goods sold
|
$
|
20,391
|
|
|
$
|
14,791
|
|
|
38%
|
|
$
|
58,472
|
|
|
$
|
36,396
|
|
|
61%
|
Gross margin *
|
61
|
%
|
|
36
|
%
|
|
|
|
57
|
%
|
|
29
|
%
|
|
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
|
Nine Months Ended
|
|
% Increase / (Decrease)
|
||||||||||||
|
September 30,
|
|
|
September 30,
|
|
||||||||||||||
|
2014
|
|
2013
|
|
|
2014
|
|
2013
|
|
||||||||||
Clinical development
|
$
|
1,128
|
|
|
$
|
2,665
|
|
|
(58)%
|
|
$
|
4,717
|
|
|
$
|
8,944
|
|
|
(47)%
|
Stock-based compensation
|
1,823
|
|
|
1,660
|
|
|
10%
|
|
5,537
|
|
|
3,124
|
|
|
77%
|
||||
Other
|
1,474
|
|
|
1,637
|
|
|
(10)%
|
|
4,590
|
|
|
4,656
|
|
|
(1)%
|
||||
Total research and development expense
|
$
|
4,425
|
|
|
$
|
5,962
|
|
|
(26)%
|
|
$
|
14,844
|
|
|
$
|
16,724
|
|
|
(11)%
|
|
Three Months Ended
|
|
% Increase
|
|
Nine Months Ended
|
|
% Increase
|
||||||||||||
|
September 30,
|
|
|
September 30,
|
|
||||||||||||||
|
2014
|
|
2013
|
|
|
2014
|
|
2013
|
|
||||||||||
Sales and marketing
|
$
|
17,083
|
|
|
$
|
9,426
|
|
|
81%
|
|
$
|
46,948
|
|
|
$
|
26,204
|
|
|
79%
|
General and administrative
|
6,458
|
|
|
4,191
|
|
|
54%
|
|
19,356
|
|
|
12,070
|
|
|
60%
|
||||
Stock-based compensation
|
4,676
|
|
|
1,703
|
|
|
175%
|
|
9,339
|
|
|
4,062
|
|
|
130%
|
||||
Total selling, general and administrative expense
|
$
|
28,217
|
|
|
$
|
15,320
|
|
|
84%
|
|
$
|
75,643
|
|
|
$
|
42,336
|
|
|
79%
|
•
|
Sales and marketing expenses increased by
$7.7
million mainly due to a $4.7 million increase in project spend for EXPAREL, which included educational initiatives and programs to create product awareness in the orthopedic and soft tissue markets, commission based payments to CrossLink BioScience, LLC, or CrossLink, and selling and promotional activities to support the growth of EXPAREL. Salaries and benefits increased $2.7 million, primarily driven by an increase in our sales force and field-based medical affairs personnel;
|
•
|
General and administrative expenses increased by
$2.3
million, primarily due to increases in salaries and benefits associated with our increased headcount as well as other regulatory, legal and support initiatives to aid both the commercial and manufacturing growth of EXPAREL; and
|
•
|
Stock-based compensation expense increased by $3.0 million, attributable to an increase in headcount and a company-wide grant of stock options.
|
•
|
Sales and marketing expenses increased by
$20.7
million due to a $13.0 million increase in project spend for EXPAREL, which included educational initiatives and programs to create product awareness in the orthopedic and soft tissue markets, commission based payments to CrossLink and selling and promotional activities to support the growth of EXPAREL. Salaries and benefits increased $6.8 million, primarily driven by an increase in our sales force and field-based medical affairs personnel;
|
•
|
General and administrative expenses increased by
$7.3
million, due to increases in salaries and benefits associated with our increased headcount as well as other regulatory, legal and support initiatives to aid both the commercial and manufacturing growth of EXPAREL; and
|
•
|
Stock-based compensation expense increased by $5.3 million, attributable to an increase in headcount and a company-wide grant of stock options.
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
|
Nine Months Ended
|
|
% Increase / (Decrease)
|
||||||||||||
|
September 30,
|
|
|
September 30,
|
|
||||||||||||||
|
2014
|
|
2013
|
|
|
2014
|
|
2013
|
|
||||||||||
Interest income
|
$
|
134
|
|
|
$
|
62
|
|
|
116%
|
|
$
|
237
|
|
|
$
|
207
|
|
|
14%
|
Interest expense
|
(2,037
|
)
|
|
(1,892
|
)
|
|
8%
|
|
(6,222
|
)
|
|
(5,325
|
)
|
|
17%
|
||||
Loss on early extinguishment of debt
|
—
|
|
|
—
|
|
|
N/A
|
|
—
|
|
|
(3,398
|
)
|
|
(100)%
|
||||
Royalty interest obligation
|
(73
|
)
|
|
(132
|
)
|
|
(45)%
|
|
(330
|
)
|
|
(379
|
)
|
|
(13)%
|
||||
Other, net
|
(43
|
)
|
|
(8
|
)
|
|
438%
|
|
(120
|
)
|
|
(30
|
)
|
|
300%
|
||||
Total other expense, net
|
$
|
(2,019
|
)
|
|
$
|
(1,970
|
)
|
|
2%
|
|
$
|
(6,435
|
)
|
|
$
|
(8,925
|
)
|
|
(28)%
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
|
Nine Months Ended
|
|
% Increase / (Decrease)
|
||||||||||||
|
September 30,
|
|
|
September 30,
|
|
||||||||||||||
|
2014
|
|
2013
|
|
|
2014
|
|
2013
|
|
||||||||||
Income tax benefit
|
$
|
—
|
|
|
$
|
—
|
|
|
N/A
|
|
$
|
—
|
|
|
$
|
442
|
|
|
(100)%
|
|
Nine Months Ended
|
||||||
|
September 30,
|
||||||
|
2014
|
|
2013
|
||||
Net cash provided by (used in):
|
|
|
|
||||
Operating activities
|
$
|
12,458
|
|
|
$
|
(36,936
|
)
|
Investing activities
|
(123,356
|
)
|
|
(58,159
|
)
|
||
Financing activities
|
116,139
|
|
|
88,352
|
|
||
Net increase (decrease) in cash and cash equivalents
|
$
|
5,241
|
|
|
$
|
(6,743
|
)
|
•
|
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, including costs associated with certain technical transfer activities and construction of two dedicated manufacturing suites in the United Kingdom;
|
•
|
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 cost and timing of potential milestone payments to Skyepharma;
|
•
|
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.
|
Exhibit No.
|
|
Description
|
|
|
|
10.1
†
|
|
Second Amendment to Commercial Outsourcing Services Agreement, dated August 25, 2014, between Pacira Pharmaceuticals, Inc. and Integrated Commercialization Solutions, Inc. *
|
|
|
|
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 September 30, 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:
|
October 30, 2014
|
/s/ DAVID STACK
|
|
|
David Stack
|
|
|
President, Chief Executive Officer and Chairman
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
Dated:
|
October 30, 2014
|
/s/ JAMES SCIBETTA
|
|
|
James Scibetta
|
|
|
Senior Vice President and Chief Financial Officer
|
|
|
(Principal Financial Officer)
|
A.
|
The Company and ICS are parties to a Commercial Outsourcing Services Agreement dated August 25, 2011, as amended by the First Amendment dated August 1, 2013 (as amended, the "Agreement");
|
B.
|
Pursuant to the Agreement, among other things, the Company engaged ICS to perform commercialization services for certain pharmaceutical products; and
|
C.
|
The parties now wish to amend the Agreement in certain respects.
|
1.
|
Defined Terms
. Capitalized terms in this Amendment that are not defined in this Amendment have the meanings given to them in the Agreement. If there is any conflict between the Agreement and any provision of this Amendment, this Amendment will control.
|
2.
|
Term
. Section 4.1 of the Agreement is deleted in its entirety and replaced with the following:
|
3.
|
Schedule B
. The parties agree that effective September 1, 2014, Schedule B to the Agreement is hereby deleted in its entirety and replaced with the attached Revised Schedule B.
|
4.
|
No Other Changes
. Except as otherwise provided in this Amendment, the terms and conditions of the Agreement will continue in full force.
|
Pacira Pharmaceuticals, Inc.
By:
/s/ Kristen Williams
Name: Kristen Williams
Title: Vice President, General Counsel
|
Integrated Commercialization Solutions, Inc.
By:
/s/ Stephen W. McKinnon
Name: Stephen W. McKinnon
Title: President
|
Fee
|
Amount
|
Description
|
Monthly Management Fee
|
||
Customer Service
Warehouse & Distribution
Returns Management
Finance
Information Technology & Reporting
Chargeback Management
Sample Management
Marketing Material Management
|
$[**]
|
[**]
|
Fee
|
Amount
|
Description
|
Receiving Fee
|
$[**]
|
[**]
|
Shipping Fee
|
$[**]
|
[**]
|
Bulk Shipments
|
$[**]
|
[**]
|
Packing Supplies
|
$[**]
|
[**]
|
Freight
|
$[**]
|
[**]
|
Finance
|
||
Invoice Processing
|
$[**]
|
[**]
|
Credit Verification Reports - Dun & Bradstreet
|
$[**]
|
[**]
|
Credit Verifications Reports - Experian
|
$[**]
|
[**]
|
Returns Management
|
||
RGA Initiation
|
$[**]
|
[**]
|
Return Processing
|
$[**]
|
[**]
|
Partial Returns Processing
|
$[**]
|
[**]
|
Returns Storage
|
$[**]
|
[**]
|
Contract and Chargeback Management
|
||
Chargeback Processing - Manual
|
$[**]
|
[**]
|
Chargeback Processing - Electronic
|
$[**]
|
[**]
|
Fee
|
Amount
|
Description
|
Membership Additions
|
$[**]
|
[**]
|
Contract Setup
|
$[**]
|
[**]
|
Contract Updates
|
$[**]
|
[**]
|
Information Technology and Reporting
|
||
852/867; ABC, CAH, MCK
|
$[**]
|
[**]
|
Custom Reports
|
$[**]
|
[**]
|
Custom Development Services
|
$[**]
|
[**]
|
Additional Fees
|
||
Product Destruction
|
$[**]
|
[**]
|
Telecom
|
$[**]
|
[**]
|
FedEx/UPS/Postage Expenses
|
$[**]
|
[**]
|
Pre-Approved Assessorial Labor Charge - Warehouse
|
$[**]
|
[**]
|
Pre-Approved Assessorial Labor Charge - Office Staff
|
$[**]
|
[**]
|
Pre-Approved Assessorial Labor Charge - QC, Management
|
$[**]
|
[**]
|
ICS Travel
|
$[**]
|
[**]
|
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:
|
October 30, 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:
|
October 30, 2014
|
/s/ James Scibetta
|
|
|
James Scibetta
|
|
|
Senior Vice President and Chief Financial Officer
|
|
|
(Principal Financial Officer)
|
Date:
|
October 30, 2014
|
/s/ David Stack
|
|
|
David Stack
|
|
|
President, Chief Executive Officer and Chairman
|
|
|
(Principal Executive Officer)
|
Date:
|
October 30, 2014
|
/s/ James Scibetta
|
|
|
James Scibetta
|
|
|
Senior Vice President and Chief Financial Officer
|
|
|
(Principal Financial Officer)
|