|
|
|
|
x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
|
|
|
Delaware
|
|
51-0619477
|
(State or Other Jurisdiction of
Incorporation or Organization)
|
|
(I.R.S. Employer
Identification No.)
|
|
|
|
5 Sylvan Way, Suite 300
Parsippany, New Jersey, 07054
|
||
(Address and Zip Code of Principal Executive Offices)
|
||
|
|
|
(973) 254-3560
|
||
(Registrant’s Telephone Number, Including Area Code)
|
|
|
Large accelerated filer
x
|
|
Accelerated filer
o
|
|
|
|
Non-accelerated filer
o
|
|
Smaller reporting company
o
|
(Do not check if a smaller reporting company)
|
|
|
PACIRA PHARMACEUTICALS, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTER ENDED MARCH 31, 2016
TABLE OF CONTENTS
|
||
|
|
Page #
|
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
|
|
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
|
|||||||
|
March 31,
2016 |
|
December 31,
2015 |
||||
|
|
|
(Note 2)
|
||||
ASSETS
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
35,029
|
|
|
$
|
56,984
|
|
Short-term investments
|
114,992
|
|
|
101,981
|
|
||
Accounts receivable, net
|
25,901
|
|
|
25,855
|
|
||
Inventories, net
|
63,744
|
|
|
61,645
|
|
||
Prepaid expenses and other current assets
|
8,959
|
|
|
6,117
|
|
||
Total current assets
|
248,625
|
|
|
252,582
|
|
||
Long-term investments
|
13,470
|
|
|
13,462
|
|
||
Fixed assets, net
|
95,846
|
|
|
90,324
|
|
||
Goodwill
|
32,784
|
|
|
30,880
|
|
||
Intangibles, net
|
—
|
|
|
81
|
|
||
Other assets
|
481
|
|
|
406
|
|
||
Total assets
|
$
|
391,206
|
|
|
$
|
387,735
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
10,484
|
|
|
$
|
8,739
|
|
Accrued expenses
|
29,067
|
|
|
35,375
|
|
||
Convertible senior notes
|
105,215
|
|
|
104,040
|
|
||
Current portion of deferred revenue
|
1,275
|
|
|
1,426
|
|
||
Income taxes payable
|
98
|
|
|
208
|
|
||
Total current liabilities
|
146,139
|
|
|
149,788
|
|
||
Deferred revenue
|
7,877
|
|
|
8,082
|
|
||
Other liabilities
|
11,020
|
|
|
11,473
|
|
||
Total liabilities
|
165,036
|
|
|
169,343
|
|
||
Commitments and contingencies (Note 12)
|
|
|
|
|
|
||
Stockholders’ equity:
|
|
|
|
|
|
||
Preferred stock, par value $0.001; 5,000,000 shares authorized; none issued and outstanding at
March 31, 2016 and December 31, 2015 |
—
|
|
|
—
|
|
||
Common stock, par value $0.001, 250,000,000 shares authorized; 37,103,427 shares issued and
outstanding at March 31, 2016; 36,848,319 shares issued and outstanding at December 31, 2015 |
37
|
|
|
37
|
|
||
Additional paid-in capital
|
538,227
|
|
|
526,696
|
|
||
Accumulated deficit
|
(312,143
|
)
|
|
(308,289
|
)
|
||
Accumulated other comprehensive income (loss)
|
49
|
|
|
(52
|
)
|
||
Total stockholders’ equity
|
226,170
|
|
|
218,392
|
|
||
Total liabilities and stockholders’ equity
|
$
|
391,206
|
|
|
$
|
387,735
|
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
|
|||||||
|
Three Months Ended
|
||||||
|
March 31,
|
||||||
|
2016
|
|
2015
|
||||
Revenues:
|
|
|
|
|
|
||
Net product sales
|
$
|
64,502
|
|
|
$
|
57,086
|
|
Collaborative licensing and milestone revenue
|
356
|
|
|
356
|
|
||
Royalty revenue
|
616
|
|
|
874
|
|
||
Total revenues
|
65,474
|
|
|
58,316
|
|
||
Operating expenses:
|
|
|
|
|
|
||
Cost of goods sold
|
20,278
|
|
|
17,580
|
|
||
Research and development
|
9,493
|
|
|
5,967
|
|
||
Selling, general and administrative
|
37,957
|
|
|
31,428
|
|
||
Total operating expenses
|
67,728
|
|
|
54,975
|
|
||
Income (loss) from operations
|
(2,254
|
)
|
|
3,341
|
|
||
Other (expense) income:
|
|
|
|
|
|
||
Interest income
|
252
|
|
|
155
|
|
||
Interest expense
|
(1,868
|
)
|
|
(1,996
|
)
|
||
Royalty interest obligation
|
—
|
|
|
(71
|
)
|
||
Other, net
|
48
|
|
|
(117
|
)
|
||
Total other expense, net
|
(1,568
|
)
|
|
(2,029
|
)
|
||
Income (loss) before income taxes
|
(3,822
|
)
|
|
1,312
|
|
||
Income tax expense
|
(32
|
)
|
|
(52
|
)
|
||
Net income (loss)
|
$
|
(3,854
|
)
|
|
$
|
1,260
|
|
|
|
|
|
||||
Net income (loss) per share:
|
|
|
|
|
|
||
Basic and diluted net income (loss) per common share
|
$
|
(0.10
|
)
|
|
$
|
0.03
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
||
Basic
|
37,020
|
|
|
36,235
|
|
||
Diluted
|
37,020
|
|
|
41,779
|
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(In thousands)
(Unaudited)
|
|||||||
|
Three Months Ended
|
||||||
|
March 31,
|
||||||
|
2016
|
|
2015
|
||||
Net income (loss)
|
$
|
(3,854
|
)
|
|
$
|
1,260
|
|
Other comprehensive income:
|
|
|
|
|
|
||
Net unrealized gain on investments
|
101
|
|
|
52
|
|
||
Total other comprehensive income
|
101
|
|
|
52
|
|
||
Comprehensive income (loss)
|
$
|
(3,753
|
)
|
|
$
|
1,312
|
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
FOR THE THREE MONTHS ENDED MARCH 31, 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
|
254
|
|
|
—
|
|
|
3,041
|
|
|
—
|
|
|
—
|
|
|
3,041
|
|
|||||
Vested restricted stock units
|
1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
8,490
|
|
|
—
|
|
|
—
|
|
|
8,490
|
|
|||||
Net unrealized gain on investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
101
|
|
|
101
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,854
|
)
|
|
—
|
|
|
(3,854
|
)
|
|||||
Balances at March 31, 2016
|
37,103
|
|
|
$
|
37
|
|
|
$
|
538,227
|
|
|
$
|
(312,143
|
)
|
|
$
|
49
|
|
|
$
|
226,170
|
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
|
|||||||
|
Three Months Ended
|
||||||
|
March 31,
|
||||||
|
2016
|
|
2015
|
||||
|
|
|
(Note 2)
|
||||
Operating activities:
|
|
|
|
|
|
||
Net income (loss)
|
$
|
(3,854
|
)
|
|
$
|
1,260
|
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
|
|
|
|
|
|
||
Depreciation of fixed assets and amortization of intangibles
|
3,165
|
|
|
2,743
|
|
||
Amortization of unfavorable lease obligation and debt issuance costs, net
|
120
|
|
|
122
|
|
||
Amortization of debt discount
|
1,022
|
|
|
1,035
|
|
||
Stock-based compensation
|
8,490
|
|
|
7,517
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||
Restricted cash
|
—
|
|
|
1,509
|
|
||
Accounts receivable, net
|
(46
|
)
|
|
(2,145
|
)
|
||
Inventories, net
|
(2,099
|
)
|
|
(7,001
|
)
|
||
Prepaid expenses and other assets
|
(2,917
|
)
|
|
372
|
|
||
Accounts payable and accrued expenses
|
(6,227
|
)
|
|
(5,679
|
)
|
||
Royalty interest obligation
|
—
|
|
|
(276
|
)
|
||
Other liabilities
|
(419
|
)
|
|
29
|
|
||
Deferred revenue
|
(356
|
)
|
|
(356
|
)
|
||
Net cash used in operating activities
|
(3,121
|
)
|
|
(870
|
)
|
||
Investing activities:
|
|
|
|
|
|
||
Purchases of fixed assets
|
(7,053
|
)
|
|
(7,874
|
)
|
||
Purchases of investments
|
(67,843
|
)
|
|
(49,937
|
)
|
||
Sales of investments
|
54,925
|
|
|
59,631
|
|
||
Payment of contingent consideration
|
(1,904
|
)
|
|
(1,620
|
)
|
||
Net cash provided by (used in) investing activities
|
(21,875
|
)
|
|
200
|
|
||
Financing activities:
|
|
|
|
|
|
||
Proceeds from exercise of stock options
|
3,041
|
|
|
4,047
|
|
||
Net cash provided by financing activities
|
3,041
|
|
|
4,047
|
|
||
Net (decrease) increase in cash and cash equivalents
|
(21,955
|
)
|
|
3,377
|
|
||
Cash and cash equivalents, beginning of period
|
56,984
|
|
|
37,520
|
|
||
Cash and cash equivalents, end of period
|
$
|
35,029
|
|
|
$
|
40,897
|
|
Supplemental cash flow information:
|
|
|
|
|
|
||
Cash paid for interest, including royalty interest obligation
|
$
|
1,926
|
|
|
$
|
2,297
|
|
Cash paid for income taxes, net of refunds
|
$
|
142
|
|
|
$
|
160
|
|
Non-cash investing and financing activities:
|
|
|
|
||||
Net increase in accrued fixed assets
|
$
|
1,554
|
|
|
$
|
1,363
|
|
|
Three Months Ended
|
||
|
March 31,
|
||
|
2016
|
|
2015
|
Largest customer
|
33%
|
|
29%
|
Second largest customer
|
28%
|
|
29%
|
Third largest customer
|
27%
|
|
28%
|
|
88%
|
|
86%
|
|
March 31,
|
|
December 31,
|
||||
|
2016
|
|
2015
|
||||
Raw materials
|
$
|
16,015
|
|
|
$
|
16,712
|
|
Work-in-process
|
9,939
|
|
|
12,152
|
|
||
Finished goods
|
37,790
|
|
|
32,781
|
|
||
Total
|
$
|
63,744
|
|
|
$
|
61,645
|
|
|
March 31,
|
|
December 31,
|
||||
|
2016
|
|
2015
|
||||
Machinery and laboratory equipment
|
$
|
31,086
|
|
|
$
|
29,864
|
|
Leasehold improvements
|
32,359
|
|
|
30,834
|
|
||
Computer equipment and software
|
4,724
|
|
|
4,007
|
|
||
Office furniture and equipment
|
1,440
|
|
|
1,439
|
|
||
Construction in progress
|
54,234
|
|
|
49,097
|
|
||
Total
|
123,843
|
|
|
115,241
|
|
||
Less: accumulated depreciation
|
(27,997
|
)
|
|
(24,917
|
)
|
||
Fixed assets, net
|
$
|
95,846
|
|
|
$
|
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
; and
|
(v)
|
$32.0 million
when annual net sales collected reach
$500.0 million
.
|
|
Carrying Value
|
||
Balance at December 31, 2015
|
$
|
30,880
|
|
Percentage payments on collections of net sales of EXPAREL
|
1,904
|
|
|
Balance at March 31, 2016
|
$
|
32,784
|
|
|
March 31, 2016
|
|
December 31, 2015
|
|
|
||||||||||||||||||||
|
Gross
Carrying Value |
|
Accumulated
Amortization |
|
Intangible
Assets, Net |
|
Gross
Carrying
Value
|
|
Accumulated
Amortization
|
|
Intangible
Assets, Net
|
|
Estimated
Useful Life |
||||||||||||
Amortizable intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
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
|
|
|
|
|
March 31,
|
|
December 31,
|
||||
|
2016
|
|
2015
|
||||
Debt:
|
|
|
|
||||
3.25% convertible senior notes
|
$
|
118,533
|
|
|
$
|
118,533
|
|
Deferred financing costs
|
(1,735
|
)
|
|
(1,888
|
)
|
||
Discount on debt
|
(11,583
|
)
|
|
(12,605
|
)
|
||
Total debt, net of debt discount
|
$
|
105,215
|
|
|
$
|
104,040
|
|
|
Three Months Ended
|
||||||
|
March 31,
|
||||||
|
2016
|
|
2015
|
||||
Contractual interest expense
|
$
|
963
|
|
|
$
|
967
|
|
Amortization of debt issuance costs
|
153
|
|
|
155
|
|
||
Amortization of debt discount
|
1,022
|
|
|
1,035
|
|
||
Capitalized interest (Note 4)
|
(270
|
)
|
|
(161
|
)
|
||
Total
|
$
|
1,868
|
|
|
$
|
1,996
|
|
|
|
|
|
||||
Effective interest rate on the Notes
|
7.22
|
%
|
|
7.19
|
%
|
•
|
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
|
||||||||||||
March 31, 2016
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|||||||||
3.25% convertible senior notes *
|
|
$
|
105,215
|
|
|
$
|
—
|
|
|
$
|
262,551
|
|
|
$
|
—
|
|
March 31, 2016
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
(Level 2) |
||||||||
Debt securities:
|
|
|
|
|
|
|
|
|
||||||||
Short-term:
|
|
|
|
|
|
|
|
|
||||||||
Asset-backed securities
|
|
$
|
26,164
|
|
|
$
|
6
|
|
|
$
|
(4
|
)
|
|
$
|
26,166
|
|
Commercial paper
|
|
36,650
|
|
|
64
|
|
|
—
|
|
|
36,714
|
|
||||
Corporate bonds
|
|
52,098
|
|
|
22
|
|
|
(8
|
)
|
|
52,112
|
|
||||
Subtotal
|
|
114,912
|
|
|
92
|
|
|
(12
|
)
|
|
114,992
|
|
||||
Long-term:
|
|
|
|
|
|
|
|
|
||||||||
Corporate bonds
|
|
13,501
|
|
|
—
|
|
|
(31
|
)
|
|
13,470
|
|
||||
Total
|
|
$
|
128,413
|
|
|
$
|
92
|
|
|
$
|
(43
|
)
|
|
$
|
128,462
|
|
December 31, 2015
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
(Level 2) |
||||||||
Debt securities:
|
|
|
|
|
|
|
|
|
||||||||
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
|
||||||
|
|
March 31,
|
||||||
|
|
2016
|
|
2015
|
||||
Cost of goods sold
|
|
$
|
1,549
|
|
|
$
|
1,103
|
|
Research and development
|
|
893
|
|
|
1,510
|
|
||
Selling, general and administrative
|
|
6,048
|
|
|
4,904
|
|
||
Total
|
|
$
|
8,490
|
|
|
$
|
7,517
|
|
|
|
|
|
|
||||
Stock-based compensation from:
|
|
|
|
|
||||
Stock options (employee awards)
|
|
$
|
6,856
|
|
|
$
|
6,309
|
|
Stock options (consultant awards)
|
|
274
|
|
|
997
|
|
||
Restricted stock units (employee awards)
|
|
1,085
|
|
|
—
|
|
||
Employee stock purchase plan
|
|
275
|
|
|
211
|
|
||
Total
|
|
$
|
8,490
|
|
|
$
|
7,517
|
|
Stock Options
|
|
Number of Options
|
|
Weighted Average Exercise Price
|
|||
Outstanding at December 31, 2015
|
|
4,645,722
|
|
|
$
|
44.03
|
|
Granted
|
|
41,250
|
|
|
61.70
|
|
|
Exercised
|
|
(254,170
|
)
|
|
11.97
|
|
|
Forfeited
|
|
(216,515
|
)
|
|
71.22
|
|
|
Expired
|
|
(28,755
|
)
|
|
79.53
|
|
|
Outstanding at March 31, 2016
|
|
4,187,532
|
|
|
44.51
|
|
Restricted Stock Units
|
|
Number of Units
|
|
Weighted Average Grant Date Fair Value
|
|||
Unvested at December 31, 2015
|
|
216,198
|
|
|
$
|
78.59
|
|
Granted
|
|
1,150
|
|
|
63.84
|
|
|
Vested
|
|
(938
|
)
|
|
79.43
|
|
|
Forfeited
|
|
(17,838
|
)
|
|
79.43
|
|
|
Unvested at March 31, 2016
|
|
198,572
|
|
|
78.34
|
|
|
|
Three Months Ended
|
||||||
|
|
March 31,
|
||||||
Net unrealized gains (losses) from available for sale investments:
|
|
2016
|
|
2015
|
||||
Balance at beginning of period
|
|
$
|
(52
|
)
|
|
$
|
(80
|
)
|
Other comprehensive income before reclassifications
|
|
101
|
|
|
52
|
|
||
Amounts reclassified from accumulated other comprehensive income (loss)
|
|
—
|
|
|
—
|
|
||
Balance at end of period
|
|
$
|
49
|
|
|
$
|
(28
|
)
|
|
Three Months Ended
|
||||||
March 31,
|
|||||||
2016
|
|
2015
|
|||||
Numerator:
|
|
|
|
||||
Net income (loss)
|
$
|
(3,854
|
)
|
|
$
|
1,260
|
|
Denominator:
|
|
|
|
||||
Weighted average shares of common stock outstanding—basic
|
37,020
|
|
|
36,235
|
|
||
Computation of diluted securities:
|
|
|
|
||||
Dilutive effect of stock options
|
—
|
|
|
1,885
|
|
||
Dilutive effect of conversion premium on the Notes
|
—
|
|
|
3,652
|
|
||
Dilutive effect of warrants
|
—
|
|
|
6
|
|
||
Dilutive effect of ESPP
|
—
|
|
|
1
|
|
||
Weighted average shares of common stock outstanding—diluted
|
37,020
|
|
|
41,779
|
|
||
Net income (loss) per share:
|
|
|
|
||||
Basic and diluted net income (loss) per share of common stock
|
$
|
(0.10
|
)
|
|
$
|
0.03
|
|
|
Three Months Ended
|
||||
|
March 31,
|
||||
|
2016
|
|
2015
|
||
Weighted average number of stock options
|
4,324
|
|
|
1,323
|
|
Weighted average number of RSUs
|
205
|
|
|
—
|
|
Conversion premium on the Notes
|
2,749
|
|
|
—
|
|
Weighted average number of warrants
|
3
|
|
|
—
|
|
Weighted average purchase options under ESPP
|
23
|
|
|
—
|
|
Total
|
7,304
|
|
|
1,323
|
|
|
Three Months Ended
|
||||||
|
March 31,
|
||||||
|
2016
|
|
2015
|
||||
Income (loss) before income taxes:
|
|
|
|
||||
Domestic
|
$
|
(3,499
|
)
|
|
$
|
1,886
|
|
Foreign
|
(323
|
)
|
|
(574
|
)
|
||
Total income (loss) before income taxes
|
$
|
(3,822
|
)
|
|
$
|
1,312
|
|
Year
|
|
Aggregate Minimum Payments
|
||
2016 (remaining nine months)
|
|
$
|
5,749
|
|
2017
|
|
7,878
|
|
|
2018
|
|
8,081
|
|
|
2019
|
|
8,303
|
|
|
2020
|
|
6,420
|
|
|
2021 through 2028
|
|
8,731
|
|
|
Total
|
|
$
|
45,162
|
|
•
|
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
$7.2 million
, or
12%
, in the three months ended
March 31, 2016
, as compared to the same period in 2015, primarily driven by EXPAREL net product sales of
$63.8 million
, up
$7.8 million
, or
14%
.
|
•
|
In February 2016, we announced topline results of a randomized controlled EXPAREL trial in third molar, or “wisdom teeth”, procedures, 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 plan to generate Phase 4 studies in additional oral and maxillofacial surgeries to provide clinical guidance to the oral and maxillofacial community. We anticipate a late third quarter 2016 launch for oral surgery.
|
•
|
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 will be responsible for all financial and capital market activities, including accounting, financial reporting, financial planning and analysis and investor relations. He will succeed our former Chief Financial Officer, James Scibetta, who will continue to serve as President. Our new Chief Commercial Officer, Robert Weiland, will oversee commercial activities for EXPAREL, which include marketing, sales, national accounts, training and commercial operations and analytics.
|
•
|
In April 2016, we enrolled the first patient in our 300 patient EXPAREL infiltration total knee arthroplasty, or TKA, randomized controlled trial. We expect to complete enrollment in the second half of 2016.
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
||||||
|
March 31,
|
|
|||||||
|
2016
|
|
2015
|
|
|||||
Net product sales:
|
|
|
|
|
|
||||
EXPAREL
|
$
|
63,752
|
|
|
$
|
55,951
|
|
|
14%
|
DepoCyt(e)
|
750
|
|
|
1,135
|
|
|
(34)%
|
||
Total net product sales
|
64,502
|
|
|
57,086
|
|
|
13%
|
||
Collaborative licensing and milestone revenue
|
356
|
|
|
356
|
|
|
—%
|
||
Royalty revenue
|
616
|
|
|
874
|
|
|
(30)%
|
||
Total revenues
|
$
|
65,474
|
|
|
$
|
58,316
|
|
|
12%
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
||||||
|
March 31,
|
|
|||||||
|
2016
|
|
2015
|
|
|||||
Clinical studies
|
$
|
4,335
|
|
|
$
|
1,958
|
|
|
121%
|
Product development and other
|
4,265
|
|
|
2,499
|
|
|
71%
|
||
Stock-based compensation
|
893
|
|
|
1,510
|
|
|
(41)%
|
||
Total research and development expense
|
$
|
9,493
|
|
|
$
|
5,967
|
|
|
59%
|
% of total revenues
|
14
|
%
|
|
10
|
%
|
|
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
||||||
|
March 31,
|
|
|||||||
|
2016
|
|
2015
|
|
|||||
Sales and marketing
|
$
|
20,338
|
|
|
$
|
18,172
|
|
|
12%
|
General and administrative
|
11,571
|
|
|
8,352
|
|
|
39%
|
||
Stock-based compensation
|
6,048
|
|
|
4,904
|
|
|
23%
|
||
Total selling, general and administrative expenses
|
$
|
37,957
|
|
|
$
|
31,428
|
|
|
21%
|
% of total revenues
|
58
|
%
|
|
54
|
%
|
|
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
||||||
|
March 31,
|
|
|||||||
|
2016
|
|
2015
|
|
|||||
Interest income
|
$
|
252
|
|
|
$
|
155
|
|
|
63%
|
Interest expense
|
(1,868
|
)
|
|
(1,996
|
)
|
|
(6)%
|
||
Royalty interest obligation
|
—
|
|
|
(71
|
)
|
|
(100)%
|
||
Other, net
|
48
|
|
|
(117
|
)
|
|
N/A
|
||
Total other expense, net
|
$
|
(1,568
|
)
|
|
$
|
(2,029
|
)
|
|
(23)%
|
|
Three Months Ended
|
|
% Increase / (Decrease)
|
||||||
|
March 31,
|
|
|||||||
|
2016
|
|
2015
|
|
|||||
Income tax expense
|
$
|
32
|
|
|
$
|
52
|
|
|
(38)%
|
Effective tax rate
|
(1
|
)%
|
|
4
|
%
|
|
|
|
|
Three Months Ended
|
||||||
|
|
March 31,
|
||||||
Consolidated Statement of Cash Flows Data:
|
|
2016
|
|
2015
|
||||
Net cash provided by (used in):
|
|
|
|
|
||||
Operating activities
|
|
$
|
(3,121
|
)
|
|
$
|
(870
|
)
|
Investing activities
|
|
(21,875
|
)
|
|
200
|
|
||
Financing activities
|
|
3,041
|
|
|
4,047
|
|
||
Net (decrease) increase in cash and cash equivalents
|
|
$
|
(21,955
|
)
|
|
$
|
3,377
|
|
•
|
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, United Kingdom 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 $44.0 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 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.
|
March 31, 2016
|
|
Returns Allowances
|
|
Prompt Pay Discounts
|
|
Wholesaler Service Fees
|
|
Volume
Rebates and Chargebacks |
|
Total
|
||||||||||
Balance at December 31, 2015
|
|
$
|
1,733
|
|
|
$
|
625
|
|
|
$
|
745
|
|
|
$
|
797
|
|
|
$
|
3,900
|
|
Provision
|
|
166
|
|
|
1,302
|
|
|
982
|
|
|
418
|
|
|
2,868
|
|
|||||
Payments/Credits
|
|
(289
|
)
|
|
(1,412
|
)
|
|
(1,195
|
)
|
|
(601
|
)
|
|
(3,497
|
)
|
|||||
Balance at March 31, 2016
|
|
$
|
1,610
|
|
|
$
|
515
|
|
|
$
|
532
|
|
|
$
|
614
|
|
|
$
|
3,271
|
|
March 31, 2015
|
|
Returns Allowances
|
|
Prompt Pay Discounts
|
|
Wholesaler Service Fees
|
|
Volume
Rebates and Chargebacks |
|
Total
|
||||||||||
Balance at December 31, 2014
|
|
$
|
1,559
|
|
|
$
|
575
|
|
|
$
|
588
|
|
|
$
|
321
|
|
|
$
|
3,043
|
|
Provision
|
|
117
|
|
|
1,139
|
|
|
830
|
|
|
350
|
|
|
2,436
|
|
|||||
Payments/Credits
|
|
(21
|
)
|
|
(1,108
|
)
|
|
(934
|
)
|
|
(412
|
)
|
|
(2,475
|
)
|
|||||
Balance at March 31, 2015
|
|
$
|
1,655
|
|
|
$
|
606
|
|
|
$
|
484
|
|
|
$
|
259
|
|
|
$
|
3,004
|
|
Exhibit No.
|
|
Description
|
|
|
|
10.1 +
|
|
Executive Employment Agreement, dated June 11, 2015, between Pacira Pharmaceuticals, Inc. and Scott Braunstein.*
|
|
|
|
10.2 +
|
|
Executive Employment Agreement, dated August 24, 2015, between Pacira Pharmaceuticals, Inc. and James Jones.*
|
|
|
|
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 President and 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 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, 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:
|
May 2, 2016
|
/s/ DAVID STACK
|
|
|
David Stack
|
|
|
Chief Executive Officer and Chairman
|
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(Principal Executive Officer)
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Dated:
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May 2, 2016
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/s/ JAMES SCIBETTA
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James Scibetta
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President and Chief Financial Officer
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(Principal Financial Officer)
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1.
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I have reviewed this quarterly report on Form 10-Q of Pacira Pharmaceuticals, Inc. (the “Registrant”);
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2.
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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;
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3.
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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;
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4.
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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:
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(a)
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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;
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(b)
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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;
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(c)
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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
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(d)
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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
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5.
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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):
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(a)
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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
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(b)
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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.
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Date:
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May 2, 2016
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/s/ David Stack
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David Stack
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Chief Executive Officer and Chairman
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(Principal Executive Officer)
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1.
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I have reviewed this quarterly report on Form 10-Q of Pacira Pharmaceuticals, Inc. (the “Registrant”);
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2.
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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;
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3.
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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;
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4.
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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:
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(a)
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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;
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(b)
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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;
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(c)
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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
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(d)
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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
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5.
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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):
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(a)
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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
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(b)
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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.
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Date:
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May 2, 2016
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/s/ James Scibetta
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James Scibetta
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President and Chief Financial Officer
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(Principal Financial Officer)
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Date:
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May 2, 2016
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/s/ David Stack
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David Stack
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Chief Executive Officer and Chairman
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(Principal Executive Officer)
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Date:
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May 2, 2016
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/s/ James Scibetta
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James Scibetta
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President and Chief Financial Officer
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(Principal Financial Officer)
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