10-Q 1 prx-6302012x10q.htm FORM 10-Q PRX-6.30.2012-10Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC  20549

________________

FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended: June 30, 2012
Commission file number: 1-10827


PAR PHARMACEUTICAL COMPANIES, INC.
(Exact name of registrant as specified in its charter)


Delaware
 
22-3122182
(State or other jurisdiction of
 
(I.R.S. Employer
incorporation or organization)
 
Identification No.)


300 Tice Boulevard, Woodcliff Lake, New Jersey 07677
(Address of principal executive offices)
Registrant’s telephone number, including area code:  (201) 802-4000


Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes  X  No___ 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes  X  No___  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer.  See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act:  

Large accelerated filer [ X ]      Accelerated filer [   ]    Non-accelerated filer [   ]


Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes        No  X_
  

Number of shares of the Registrant’s common stock outstanding as of July 18, 2012: 36,833,149




TABLE OF CONTENTS
PAR PHARMACEUTICAL COMPANIES, INC.
FORM 10-Q
FOR THE QUARTER ENDED JUNE 30, 2012

PART I
FINANCIAL INFORMATION
PAGE
 
 
 
 
 
Item 1.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
71
 
 
 
 
 
Item 2.
 
 
 
 
 
Item 3.
 
 
 
 
 
Item 4.
 
 
 
 
PART II
OTHER INFORMATION
 
 
 
 
 
 
Item 1.
 
 
 
 
 
Item 1A.
 
 
 
 
 
Item 2.
 
 
 
 
 
Item 6.
 
 
 
 
 




2


PART I. FINANCIAL INFORMATION
ITEM 1.  FINANCIAL STATEMENTS

PAR PHARMACEUTICAL COMPANIES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Share and Per Share Data)
(Unaudited)
 
June 30,
2012
 
December 31,
2011
ASSETS
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
241,527

 
$
162,516

Available for sale marketable debt securities
19,459

 
25,709

Accounts receivable, net  
156,067

 
125,940

Inventories
89,247

 
106,250

Prepaid expenses and other current assets
24,450

 
20,475

Deferred income tax assets
45,080

 
55,966

Income taxes receivable
11,358

 
27,049

Total current assets
587,188

 
523,905

Property, plant and equipment, net
102,373

 
97,790

Intangible assets, net
289,037

 
311,669

Goodwill
309,551

 
283,432

Other assets
13,567

 
14,657

Total assets
$
1,301,716

 
$
1,231,453

LIABILITIES AND STOCKHOLDERS’ EQUITY
 
 
 
Current liabilities:
 
 
 
Current portion of long-term debt
$
30,625

 
$
21,875

Accounts payable
37,203

 
33,000

Payables due to distribution agreement partners
64,971

 
69,359

Accrued salaries and employee benefits
13,840

 
16,174

Accrued government pricing liabilities
28,468

 
39,614

Accrued legal fees
7,237

 
4,150

Accrued legal settlements
82,800

 
37,800

Payable to former Anchen securityholders
12,630

 
20,620

Accrued expenses and other current liabilities
21,983

 
9,604

Total current liabilities
299,757

 
252,196

Long-term liabilities
24,211

 
19,952

Non-current deferred tax liabilities
26,722

 
25,974

Long-term debt, less current portion
306,250

 
323,750

Commitments and contingencies

 

Stockholders' equity:
 
 
 
Common stock, par value $0.01 per share, authorized 90,000,000 shares; issued
 
 
 
39,989,734 and 39,677,291 shares
400

 
397

Additional paid-in capital
403,883

 
389,166

Retained earnings
325,538

 
302,984

Accumulated other comprehensive income
37

 
13

Treasury stock, at cost 3,229,853 and 3,201,858 shares
(85,082
)
 
(82,979
)
Total stockholders' equity
644,776

 
609,581

Total liabilities and stockholders’ equity
$
1,301,716

 
$
1,231,453

 
The accompanying notes are an integral part of these condensed consolidated financial statements.

3


PAR PHARMACEUTICAL COMPANIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Per Share Data)
(Unaudited)

 
Three months ended
 
Six months ended
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Revenues:
 
 
 
 
 
 
 
Net product sales
$
285,797

 
$
215,018

 
$
549,920

 
$
435,807

Other product related revenues
8,536

 
9,170

 
15,885

 
21,333

Total revenues
294,333

 
224,188

 
565,805

 
457,140

Cost of goods sold, excluding amortization expense
138,371

 
122,556

 
303,175

 
243,094

Amortization expense
12,808

 
2,606

 
21,630

 
5,367

Total cost of goods sold
151,179

 
125,162

 
324,805

 
248,461

Gross margin
143,154

 
99,026

 
241,000

 
208,679

Operating expenses:
 
 
 
 
 
 
 
Research and development
20,716

 
8,077

 
50,616

 
18,787

Selling, general and administrative
39,667

 
46,156

 
81,826

 
93,101

Intangible asset impairment

 

 
2,000

 

Settlements and loss contingencies, net

 

 
45,000

 
190,560

Restructuring costs

 
26,986

 

 
26,986

Total operating expenses
60,383

 
81,219

 
179,442

 
329,434

Operating income (loss)
82,771

 
17,807

 
61,558

 
(120,755
)
Interest income
140

 
382

 
276

 
805

Interest expense
(3,069
)
 
(150
)
 
(6,163
)
 
(301
)
Income (loss) from continuing operations before
    provision (benefit) for income taxes
79,842

 
18,039

 
55,671

 
(120,251
)
Provision (benefit) for income taxes
28,537

 
8,859

 
33,062

 
(20,587
)
Income (loss) from continuing operations
51,305

 
9,180

 
22,609

 
(99,664
)
Discontinued operations:
 
 
 
 
 
 
 
Provision for income taxes
28

 
127

 
55

 
253

Loss from discontinued operations
(28
)
 
(127
)
 
(55
)
 
(253
)
Net income (loss)
$
51,277

 
$
9,053

 
$
22,554

 
$
(99,917
)
Basic earnings (loss) per share of common stock:
 
 
 
 
 
 
 
Income (loss) from continuing operations
$
1.41

 
$
0.26

 
$
0.62

 
$
(2.79
)
Loss from discontinued operations

 
(0.01
)
 

 
(0.01
)
Net income (loss)
$
1.41

 
$
0.25

 
$
0.62

 
$
(2.80
)
Diluted earnings (loss) per share of common stock:
 
 
 
 
 
 
 
Income (loss) from continuing operations
$
1.38

 
$
0.25

 
$
0.61

 
$
(2.79
)
Loss from discontinued operations

 

 

 
(0.01
)
Net income (loss)
$
1.38

 
$
0.25

 
$
0.61

 
$
(2.80
)
Weighted average number of common shares
    outstanding:
 
 
 
 
 
 
 
Basic
36,478

 
35,983

 
36,392

 
35,742

Diluted
37,194

 
36,708

 
37,122

 
35,742

 
The accompanying notes are an integral part of these condensed consolidated financial statements.

4


PAR PHARMACEUTICAL COMPANIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(In Thousands)
(Unaudited)

 
Three months ended
 
Six months ended
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Net income (loss)
$
51,277

 
$
9,053

 
$
22,554

 
$
(99,917
)
Other comprehensive income (loss), net of tax :
 
 
 
 
 
 
 
Unrealized gain (loss) on marketable securities, net of tax
24

 
(15
)
 
59

 
(69
)
Add: reclassification adjustment for net gains (losses) included in net income, net of tax

 

 

 

Other comprehensive income (loss)
24

 
(15
)
 
59

 
(69
)
Comprehensive income (loss)
$
51,301

 
$
9,038

 
$
22,613

 
$
(99,986
)

The accompanying notes are an integral part of these condensed consolidated financial statements.

5


PAR PHARMACEUTICAL COMPANIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
(Unaudited)
 
Six months ended
 
June 30,
2012
 
June 30,
2011
Cash flows from operating activities:
 
 
 
Net income (loss)
$
22,554

 
$
(99,917
)
Deduct: Loss from discontinued operations
(55
)
 
(253
)
Income (loss) from continuing operations
22,609

 
(99,664
)
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
 
 
 
Deferred income taxes    
10,690

 
9,162

Depreciation and amortization
31,341

 
12,381

Intangible asset impairment
2,000

 
24,226

Allowances against accounts receivable
11,858

 
6,280

Share-based compensation expense
4,709

 
5,582

Tax deficiency on exercises of stock options
(357
)
 
(382
)
Other, net
646

 
624

Changes in assets and liabilities:
 
 
 
Increase in accounts receivable
(41,985
)
 
(33,205
)
Decrease (increase) in inventories
17,195

 
(2,773
)
(Increase) decrease in prepaid expenses and other assets
(1,742
)
 
2,139

Increase in accounts payable, accrued expenses and other liabilities
32,133

 
196,544

(Decrease) increase in payables due to distribution agreement partners
(4,388
)
 
25,125

Decrease (increase) in income taxes receivable/payable
17,737

 
(45,899
)
       Net cash provided by operating activities
102,446

 
100,140

Cash flows from investing activities:
 
 
 
Capital expenditures
(7,984
)
 
(5,587
)
Adjustment to purchase price of Anchen acquistion
3,786

 

Business acquisitions
(24,686
)
 

Purchases of intangibles

 
(450
)
Purchases of available for sale debt securities
(6,566
)
 
(23,410
)
Proceeds from maturity and sale of available for sale marketable debt securities
12,500

 
12,000

Net cash used in investing activities
(22,950
)
 
(17,447
)
Cash flows from financing activities:
 

 
 
Proceeds from issuances of common stock upon exercise of stock options
5,436

 
9,810

Proceeds from the issuance of common stock under the Employee Stock Purchase Program
172

 
170

Excess tax benefits on share-based compensation
4,760

 
6,859

Purchase of treasury stock
(2,103
)
 
(7,062
)
Principal payments under long-term debt
(8,750
)
 

Cash settlement of share-based compensation

 
(4,133
)
 Net cash (used in) provided by financing activities
(485
)
 
5,644

Net increase in cash and cash equivalents
79,011

 
88,337

Cash and cash equivalents at beginning of period
162,516

 
218,674

Cash and cash equivalents at end of period
$
241,527

 
$
307,011

Supplemental disclosure of cash flow information:
 
 
 
Cash paid during the period for:
 
 
 
Income taxes, net
$
6,893

 
$
9,120

Interest paid
$
4,783

 
$
198

Non-cash transactions:  
 
 
 
Capital expenditures incurred but not yet paid
$
1,152

 
$
698

 
The accompanying notes are an integral part of these condensed consolidated financial statements.

6


PAR PHARMACEUTICAL COMPANIES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2012
(Unaudited)

Par Pharmaceutical Companies, Inc. operates primarily through its wholly owned subsidiary, Par Pharmaceutical, Inc. (collectively referred to herein as “the Company,” “we,” “our,” or “us”), in two business segments.  Our generic products division, Par Pharmaceutical (“Par”), develops (including through third party development arrangements and product acquisitions), manufactures and distributes generic pharmaceuticals in the United States.  Our branded products division, Strativa Pharmaceuticals (“Strativa”), manufactures and distributes branded pharmaceuticals in the United States.  The products we market are principally in the solid oral dosage form (tablet, caplet and two-piece hard-shell capsule), although we also distribute several oral suspension products, nasal spray products, and products delivered by injection.   
On November 17, 2011, we completed our acquisition of Anchen Incorporated and its subsidiary Anchen Pharmaceuticals, Inc., a privately held generic pharmaceutical company.  Anchen became part of Par as of the acquisition date (see Note 2, “Anchen Acquisition”).  
On February 17, 2012, we completed our acquisition of Edict Pharmaceuticals Private Limited (referred to as “Edict” or “Edict Pharmaceuticals”), a Chennai, India-based developer and manufacturer of generic pharmaceuticals, for $36,600 thousand in cash, liabilities and our repayment of certain additional pre-close indebtedness.  Edict became part of Par as of the acquisition date (see Note 3, “Edict Acquisition”).  Edict has been renamed Par Formulations Private Limited.
We divested FineTech Laboratories, Ltd, effective December 31, 2005.  The FineTech divestiture is being reported as a discontinued operation in all applicable periods presented (see Note 17 - “Discontinued Operations – Related Party Transaction”).

Note 1 - Basis of Presentation:
The accompanying condensed consolidated financial statements at June 30, 2012 and for the three-month and six-month periods ended June 30, 2012 and June 30, 2011 are unaudited.  In the opinion of management, however, such statements include all normal recurring adjustments necessary to present fairly the information presented therein.  The condensed consolidated balance sheet at December 31, 2011 was derived from the Company’s audited consolidated financial statements included in the 2011 Annual Report on Form 10-K.  
Pursuant to accounting requirements of the Securities and Exchange Commission (the “SEC”) applicable to Quarterly Reports on Form 10-Q, the accompanying condensed consolidated financial statements and these notes to condensed consolidated financial statements do not include all disclosures required by the accounting principles generally accepted in the United States of America for audited financial statements.  Accordingly, these statements should be read in conjunction with our 2011 Annual Report on Form 10-K.  Results of operations for interim periods are not necessarily indicative of those that may be achieved for full fiscal years.

Note 2 – Anchen Acquisition:
On November 17, 2011, through Par Pharmaceutical, Inc., our wholly-owned subsidiary, we completed our acquisition of Anchen Incorporated and its subsidiary Anchen Pharmaceuticals, Inc. (collectively referred to as “Anchen”) for $412,753 thousand in aggregate consideration (the “Anchen Acquisition”), subject to post-closing adjustment. During the second quarter of 2012, we collected $3,786 thousand as a result of post-closing adjustments with the former Anchen securityholders and adjusted goodwill associated with the Anchen Acquisition as of June 30, 2012. We also believe the purchase price allocation is final.

Note 3 – Edict Acquisition:
On February 17, 2012, through Par Pharmaceutical, Inc., our wholly-owned subsidiary, we completed our acquisition of Edict Pharmaceuticals Private Limited, which has been renamed Par Formulations Private Limited (referred to as “Par Formulations”), for cash and our repayment of certain additional pre-close indebtedness (the “Edict Acquisition”).  The operating results of Par Formulations were included in our condensed consolidated financial results from the date of acquisition.  The operating results were reflected as part of the Par Pharmaceutical segment.  We funded the purchase from cash on hand. 
Edict Pharmaceuticals, which is now known as Par Formulations, was a privately-held generic pharmaceutical company until our acquisition.  Par Formulations broadens our industry expertise and expands our R&D and manufacturing capabilities.  The operating results of Par Formulations from February 17, 2012 to June 30, 2012 are included in the accompanying Condensed Consolidated Statements of Operations, reflecting a loss from continuing operations of approximately $1,888 thousand.  The Condensed Consolidated Balance Sheet as of June 30, 2012 reflects the Edict Acquisition

7


, including goodwill, which represents the Par Formulations workforce’s expertise in R&D and manufacturing.  
The Edict Acquisition has been accounted for as a business purchase combination using the acquisition method of accounting under the provisions of ASC 805.  The acquisition method of accounting uses the fair value concept defined in ASC 820, “Fair Value Measurements and Disclosures.”  ASC 805 requires, among other things, that most assets acquired and liabilities assumed in a business purchase combination be recognized at their fair values as of the Edict Acquisition date and that the fair value of acquired IPR&D be recorded on the balance sheet regardless of the likelihood of success of the related product or technology as of the completion of the Edict Acquisition.  The process for estimating the fair values of IPR&D, identifiable intangible assets and certain tangible assets requires the use of significant estimates and assumptions, including estimating future cash flows, developing appropriate discount rates, estimating the costs, timing and probability of success to complete in-process projects and projecting regulatory approvals.  Under ASC 805, transaction costs are not included as a component of consideration transferred and were expensed as incurred.  The Edict Acquisition related transaction costs expensed totaled $2,880 thousand and were included in operating expenses as selling, general and administrative for the year ended December 31, 2011 and the six months ended June 30, 2012.  The excess of the purchase price (consideration transferred) over the estimated amounts of identifiable assets and liabilities of Edict as of the effective date of the acquisition was allocated to goodwill in accordance with ASC 805.  The purchase price allocation is subject to completion of our analysis of the fair value of the assets and liabilities of Edict as of the effective date of the Edict Acquisition.  Accordingly, the purchase price allocation below is preliminary and may be adjusted upon completion of the final valuation. These adjustments could be material.  The final valuation is expected to be completed as soon as practicable but no later than one year from the consummation of the acquisition on February 17, 2012.  The establishment of the fair value of the consideration for an acquisition, and the allocation to identifiable tangible and intangible assets and liabilities requires the extensive use of accounting estimates and management judgment.  We believe the fair values assigned to the assets acquired and liabilities assumed are based on reasonable estimates and assumptions based on data currently available.  

  Consideration Transferred
The acquisition-date fair value of the consideration transferred consisted of the following items ($ in thousands):

 
Amount
 
Cash paid for equity
$
20,659

 
Contingent purchase price liabilities
11,641

(1)
Cash paid for assumed indebtedness
4,300

 
Total consideration
$
36,600

  

(1)
Contingent purchase price liabilities represent subsequent milestone payments related to successful FDA inspection of the Par Formulations manufacturing facility and ANDA filings.  All contingent purchase price liabilities are expected to be paid within 18 months of the acquisition date.

Fair Value Estimate of Assets Acquired and Liabilities Assumed
The purchase price of Par Formulations, has been allocated on a preliminary basis to the following assets and liabilities ($ in thousands):


8


 
As of
 February 17, 2012
Cash and cash equivalents
$
273

Inventories
192

Prepaid expenses and other current assets
1,143

Property, plant and equipment
5,370

Intangible assets
1,850

Total identifiable assets
8,828

 
 
Accounts payable
995

Accrued expenses and other current liabilities
200

Deferred tax liabilities
938

Total liabilities assumed
2,133

 
 
Net identifiable assets acquired
6,695

Goodwill
29,905

Net assets acquired
$
36,600


None of the goodwill identified above and recorded on the condensed consolidated balance sheet as of June 30, 2012 will be deductible for income tax purposes.
Supplemental Pro forma Information (unaudited)
The following unaudited pro forma information for the six months ended June 30, 2012, and the six months ended June 30, 2011 assumes the Edict Acquisition occurred as of January 1, 2011.  The pro forma information is not necessarily indicative either of the combined results of operations that actually would have been realized had the Edict Acquisition been consummated during the periods for which pro forma information is presented, or is it intended to be a projection of future results or trends.   
  
Six Months ended
 
Six Months ended
(In thousands, except per share data)
June 30, 2012
 
June 30, 2011
Total revenues
$
565,805

 
$
457,140

Income (loss) from continuing operations
23,738

 
(102,783
)
Income (loss) from continuing operations per diluted share
$
0.64

 
$
(2.88
)

These amounts have been calculated after adjusting for the additional expense that would have been recorded assuming the fair value adjustments to finite-lived intangible assets ($750 thousand) had been applied on January 1, 2011, together with the consequential tax effects.  
Pro forma income from continuing operations for the six months ended June 30, 2012 was adjusted to exclude $2,880 thousand of Edict Acquisition related costs incurred with the consequential tax effects.  These costs were primarily accounting fees and legal fees.  Pro forma loss from continuing operations for the six months ended June 30, 2011 was adjusted to include the Edict Acquisition related costs with the consequential tax effects.  

Note 4 - Available for Sale Marketable Debt Securities:
At June 30, 2012 and December 31, 2011, all of our investments in marketable debt securities were classified as available for sale and, as a result, were reported at their estimated fair values on the condensed consolidated balance sheets. Refer to Note 5 - “Fair Value Measurements.”  The following is a summary of amortized cost and estimated fair value of our marketable debt securities available for sale at June 30, 2012 ($ amounts in thousands):

 
 
 
Unrealized
 
Estimated
Fair
 
Cost
 
Gain
 
(Loss)
 
Value
Corporate bonds
$
19,400

 
$
59

 
$

 
$
19,459


9


 
All available for sale marketable debt securities are classified as current on our condensed consolidated balance sheet as of June 30, 2012.
The following is a summary of amortized cost and estimated fair value of our investments in marketable debt securities available for sale at December 31, 2011 ($ amounts in thousands):

 
 
 
Unrealized
 
Estimated
Fair
 
Cost
 
Gain
 
(Loss)
 
Value
Corporate bonds
$
25,680

 
$
53

 
$
(24
)
 
$
25,709

 
The following is a summary of the contractual maturities of our available for sale debt securities at June 30, 2012 ($ amounts in thousands):

 
June 30, 2012
 
Cost
 
Estimated Fair
Value
Less than one year
$
15,786

 
$
15,814

Due between 1-2 years
2,700

 
2,730

Due between 2-5 years
914

 
915

Total
$
19,400

 
$
19,459

 
Note 5 – Fair Value Measurements:
FASB ASC 820-10 Fair Value Measurements and Disclosures defines fair value as the price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.  FASB ASC 820 requires that assets and liabilities carried at fair value be classified and disclosed in one of the following three categories:

Level 1:
Quoted market prices in active markets for identical assets and liabilities.  Active market means a market in which transactions for assets or liabilities occur with “sufficient frequency” and volume to provide pricing information on an ongoing unadjusted basis.  Cash equivalents include highly liquid investments with an original maturity of three months or less at acquisition. We have determined that our cash equivalents in their entirety are classified as Level 1 within the fair value hierarchy.
Level 2:
Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.  Our Level 2 assets primarily include debt securities, including corporate bonds with quoted prices that are traded less frequently than exchange-traded instruments.  All of our Level 2 asset values are determined using a pricing model with inputs that are observable in the market or can be derived principally from or corroborated by observable market data.  The pricing model information is provided by third party entities (e.g., banks or brokers).  In some instances, these third party entities engage external pricing services to estimate the fair value of these securities.  We have a general understanding of the methodologies employed by the pricing services in their pricing models.  We corroborate the estimates of non-binding quotes from the third party entities’ pricing services to an independent source that provides quoted market prices from broker or dealer quotations.  We investigate large differences, if any.  Based on historical differences, we have not been required to adjust quotes provided by the third party entities’ pricing services used in estimating the fair value of these securities.  
Level 3:
Unobservable inputs that are not corroborated by market data.
The fair value of our financial assets and liabilities measured at fair value on a recurring basis as of June 30, 2012 were as follows ($ amounts in thousands):
 
 
Estimated Fair Value at
June 30, 2012
 
Level 1
 
Level 2
 
Level 3
Corporate bonds (Note 4)
$
19,459

 
$

 
$
19,459

 
$

Cash equivalents
$
245,389

 
$
245,389

 
$

 
$


10


 
The fair value of our financial assets and liabilities measured at fair value on a recurring basis as of December 31, 2011 were as follows ($ amounts in thousands):
 
 
Estimated Fair Value at
December 31, 2011
 
Level 1
 
Level 2
 
Level 3
Corporate bonds (Note 4)
$
25,709

 
$

 
$
25,709

 
$

Cash equivalents
$
159,719

 
$
159,719

 
$

 
$

 
Note 6 - Accounts Receivable:
We account for revenue in accordance with FASB ASC 605 Revenue Recognition.  In accordance with that standard, we recognize revenue for product sales when title and risk of loss have transferred to our customers, when reliable estimates of rebates, chargebacks, returns and other adjustments can be made, and when collectability is reasonably assured.  This is generally at the time that products are received by our direct customers.  We also review available trade inventory levels at certain large wholesalers to evaluate any potential excess supply levels in relation to expected demand.  We determine whether we will recognize revenue at the time that our products are received by our direct customers or defer revenue recognition until a later date on a product by product basis at the time of launch.  Upon recognizing revenue from a sale, we record estimates for chargebacks, rebates and incentive programs, product returns, cash discounts and other sales reserves that reduce accounts receivable.  
The following tables summarize the impact of accounts receivable reserves and allowance for doubtful accounts on the gross trade accounts receivable balances at each balance sheet date ($ amounts in thousands):

 
June 30,
2012
 
December 31,
2011
Gross trade accounts receivable
$
311,189

 
$
269,204

Chargebacks
(28,698
)
 
(20,688
)
Rebates and incentive programs
(44,824
)
 
(35,132
)
Returns
(60,406
)
 
(58,672
)
Cash discounts and other
(21,105
)
 
(28,672
)
Allowance for doubtful accounts
(89
)
 
(100
)
Accounts receivable, net
$
156,067

 
$
125,940


Allowance for doubtful accounts
 
 
Six months ended
 
June 30,
2012
 
June 30,
2011
Balance at beginning of period
$
(100
)
 
$
(1
)
Additions – charge to expense
(4
)
 

Adjustments and/or deductions
15

 
1

Balance at end of period
$
(89
)
 
$


The following tables summarize the activity for the six months ended June 30, 2012 and the six months ended June 30, 2011, in the accounts affected by the estimated provisions described below ($ amounts in thousands):


11


 
Six months ended June 30, 2012
Accounts receivable reserves
Beginning balance
 
Provision recorded for current period sales
 
(Provision) reversal recorded for prior period sales
 
Credits processed
 
Ending balance
Chargebacks
$
(20,688
)
 
$
(205,290
)
 

(1)
$
197,280

 
$
(28,698
)
Rebates and incentive programs
(35,132
)
 
(96,881
)
 
(59
)
 
87,248

 
(44,824
)
Returns
(58,672
)
 
(15,362
)
 
1,602

(3)
12,026

 
(60,406
)
Cash discounts and other
(28,672
)
 
(58,025
)
 
(809
)
 
66,401

 
(21,105
)
Total
$
(143,164
)
 
$
(375,558
)
 
$
734

 
$
362,955

 
$
(155,033
)
 
 
 
 
 
 
 
 
 
 
Accrued liabilities (2)
$
(39,614
)
 
$
(26,909
)
 

 
$
38,055

 
$
(28,468
)

 
Six months ended June 30, 2011
Accounts receivable reserves  
Beginning balance
 
Provision recorded for current period sales
 
(Provision) reversal recorded for prior period sales
 
Credits processed
 
Ending balance
Chargebacks
$
(19,482
)
 
$
(120,659
)
 

(1)
$
121,055

 
$
(19,086
)
Rebates and incentive programs
(23,273
)
 
(52,068
)
 
660

 
51,402

 
(23,279
)
Returns
(48,928
)
 
(15,808
)
 
265

 
10,420

 
(54,051
)
Cash discounts and other
(16,606
)
 
(49,605
)
 
(357
)
 
48,414

 
(18,154
)
Total
$
(108,289
)
 
$
(238,140
)
 
$
568

 
$
231,291

 
$
(114,570
)
 
 
 
 
 
 
 
 
 
 
Accrued liabilities (2)
$
(32,169
)
 
$
(27,473
)
 
$
344

 
$
27,150

 
$
(32,148
)

(1)
Unless specific in nature, the amount of provision or reversal of reserves related to prior periods for chargebacks is not determinable on a product or customer specific basis; however, based upon historical analysis and analysis of activity in subsequent periods, we have determined that our chargeback estimates remain reasonable.
(2)
Includes amounts due to indirect customers for which no underlying accounts receivable exists and is principally comprised of Medicaid rebates and rebates due under other U.S. Government pricing programs, such as TriCare, and the Department of Veterans Affairs.  
(3)
The amount principally represents the resolution of a customer dispute in the first quarter of 2012 regarding invalid deductions taken in prior years of approximately $1,700 thousand.  

The Company sells its products directly to wholesalers, retail drug store chains, drug distributors, mail order pharmacies and other direct purchasers as well as customers that purchase its products indirectly through the wholesalers, including independent pharmacies, non-warehousing retail drug store chains, managed health care providers and other indirect purchasers.  The Company often negotiates product pricing directly with health care providers that purchase products through the Company’s wholesale customers. In those instances, chargeback credits are issued to the wholesaler for the difference between the invoice price paid to the Company by our wholesale customer for a particular product and the negotiated contract price that the wholesaler’s customer pays for that product.  Approximately 59% of our net product sales were derived from the wholesale distribution channel for the three months ended June 30, 2012 and approximately 62% for the three months ended June 30, 2011.  Approximately 60% of our net product sales were derived from the wholesale distribution channel for the six months ended June 30, 2012 and approximately 61% for the six months ended June 30, 2011. The information that the Company considers when establishing its chargeback reserves includes contract and non-contract sales trends, average historical contract pricing, actual price changes, processing time lags and customer inventory information from its three largest wholesale customers.  The Company’s chargeback provision and related reserve vary with changes in product mix, changes in customer pricing and changes to estimated wholesaler inventory.  
Customer rebates and incentive programs are generally provided to customers as an incentive for the customers to continue carrying the Company’s products or replace competing products in their distribution channels with our products. Rebate programs are based on a customer’s dollar purchases made during an applicable monthly, quarterly or annual period. The Company also provides indirect rebates, which are rebates paid to indirect customers that have purchased the Company’s products from a wholesaler under a contract with us.  The incentive programs include stocking or trade show promotions where

12


additional discounts may be given on a new product or certain existing products as an added incentive to stock the Company’s products.  We may, from time to time, also provide price and/or volume incentives on new products that have multiple competitors and/or on existing products that confront new competition in order to attempt to secure or maintain a certain market share.  The information that the Company considers when establishing its rebate and incentive program reserves are rebate agreements with, and purchases by, each customer, tracking and analysis of promotional offers, projected annual sales for customers with annual incentive programs, actual rebates and incentive payments made, processing time lags, and for indirect rebates, the level of inventory in the distribution channel that will be subject to indirect rebates.  We do not provide incentives designed to increase shipments to our customers that we believe would result in out-of-the-ordinary course of business inventory for them.  The Company regularly reviews and monitors estimated or actual customer inventory information at its three largest wholesale customers for its key products to ascertain whether customer inventories are in excess of ordinary course of business levels.
Pursuant to a drug rebate agreement with the Centers for Medicare and Medicaid Services, TriCare and similar supplemental agreements with various states, the Company provides a rebate on drugs dispensed under such government programs.  The Company determines its estimate of the Medicaid rebate accrual primarily based on historical experience of claims submitted by the various states and any new information regarding changes in the Medicaid program that might impact the Company’s provision for Medicaid rebates.  In determining the appropriate accrual amount we consider historical payment rates; processing lag for outstanding claims and payments; levels of inventory in the distribution channel; and the impact of the healthcare reform acts.  The Company reviews the accrual and assumptions on a quarterly basis against actual claims data to help ensure that the estimates made are reliable.  On January 28, 2008, the Fiscal Year 2008 National Defense Authorization Act was enacted, which expands TriCare to include prescription drugs dispensed by TriCare retail network pharmacies.  TriCare rebate accruals reflect this program expansion and are based on actual and estimated rebates on Department of Defense eligible sales.
The Company accepts returns of product according to the following criteria: (i) the product returns must be approved by authorized personnel with the lot number and expiration date accompanying any request and (ii) we generally will accept returns of products from any customer and will provide the customer with a credit memo for such returns if such products are returned between six months prior to, and 12 months following, such products’ expiration date. The Company records a provision for product returns based on historical experience, including actual rate of expired and damaged in-transit returns, average remaining shelf-lives of products sold, which generally range from 12 to 48 months, and estimated return dates. Additionally, we consider other factors when estimating the current period return provision, including levels of inventory in the distribution channel, significant market changes that may impact future expected returns, and actual product returns, and may record additional provisions for specific returns that we believe are not covered by the historical rates.
The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for paying within invoice terms, which generally range from 30 to 90 days.  The Company accounts for cash discounts by reducing accounts receivable by the full amount of the discounts that we expect our customers to take.  
In addition to the significant gross-to-net sales adjustments described above, we periodically make other sales adjustments.  The Company generally accounts for these other gross-to-net adjustments by establishing an accrual in the amount equal to its estimate of the adjustments attributable to the sale.
The Company may at its discretion provide price adjustments due to various competitive factors, through shelf-stock adjustments on customers’ existing inventory levels.  There are circumstances under which we may not provide price adjustments to certain customers as a matter of business strategy, and consequently may lose future sales volume to competitors and risk a greater level of sales returns on products that remain in the customer’s existing inventory.    
As detailed above, we have the experience and access to relevant information that we believe are necessary to reasonably estimate the amounts of such deductions from gross revenues, except as described below.  Some of the assumptions we use for certain of our estimates are based on information received from third parties, such as wholesale customer inventories and market data, or other market factors beyond our control.  The estimates that are most critical to the establishment of these reserves, and therefore, would have the largest impact if these estimates were not accurate, are estimates related to contract sales volumes, average contract pricing, customer inventories and return volumes.  The Company regularly reviews the information related to these estimates and adjusts its reserves accordingly, if and when actual experience differs from previous estimates.  With the exception of the product returns allowance, the ending balances of accounts receivable reserves and allowances generally are processed during a two-month to four-month period.

Use of Estimates in Reserves
We believe that our reserves, allowances and accruals for items that are deducted from gross revenues are reasonable and appropriate based on current facts and circumstances.  It is possible however, that other parties applying reasonable judgment to the same facts and circumstances could develop different allowance and accrual amounts for items that are deducted from gross revenues. Additionally, changes in actual experience or changes in other qualitative factors could cause our allowances and accruals to fluctuate, particularly with newly launched or acquired products.  We review the rates and

13


amounts in our allowance and accrual estimates on a quarterly basis. If future estimated rates and amounts are significantly greater than those reflected in our recorded reserves, the resulting adjustments to those reserves would decrease our reported net revenues; conversely, if actual product returns, rebates and chargebacks are significantly less than those reflected in our recorded reserves, the resulting adjustments to those reserves would increase our reported net revenues.  We regularly review the information related to these estimates and adjust our reserves accordingly, if and when actual experience differs from previous estimates.  
In 2011, Par launched propafenone, amlodipine and benazepril HCl, and budesonide and some other lower volume generic products.  As is customary and in the ordinary course of business, our revenue that has been recognized for these product launches included initial trade inventory stocking that we believed was commensurate with new product introductions. At the time of each product launch, we were able to make reasonable estimates of product returns, rebates, chargebacks and other sales reserves by using historical experience of similar product launches and significant existing demand for the products.  

Major Customers – Gross Accounts Receivable

 
June 30,
2012
 
December 31,
2011
Cardinal Health, Inc.
27%
 
19%
McKesson Corporation
26%
 
25%
CVS Caremark
14%
 
17%
AmerisourceBergen Corporation
7%
 
12%
Other customers
26%
 
27%
Total gross accounts receivable
100%
 
100%

Note 7 - Inventories:

($ amounts in thousands)
 
June 30,
2012
 
December 31,
2011
Raw materials and supplies
$
39,431

 
$
39,331

Work-in-process
7,995

 
5,330

Finished goods
41,821

 
61,589

 
$
89,247

 
$
106,250


Inventory write-offs (inclusive of pre-launch inventories detailed below)

($ amounts in thousands)
 
Three months ended
 
Six months ended
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Inventory write-offs
$
5,951

 
$
504

 
$
8,570

 
$
1,010


Par capitalizes inventory costs associated with certain products prior to regulatory approval and product launch, based on management's judgment of reasonably certain future commercial use and net realizable value, when it is reasonably certain that the pre-launch inventories will be saleable.  The determination to capitalize is made once Par (or its third party development partners) has filed an Abbreviated New Drug Application (“ANDA”) that has been acknowledged by the FDA as containing sufficient information to allow the FDA to conduct its review in an efficient and timely manner and management is reasonably certain that all regulatory and legal hurdles will be cleared.  This determination is based on the particular facts and circumstances relating to the expected FDA approval of the generic drug product being considered, and accordingly, the time frame within which the determination is made varies from product to product.  Par could be required to write down previously capitalized costs related to pre-launch inventories upon a change in such judgment, or due to a denial or delay of approval by regulatory bodies, or a delay in commercialization, or other potential factors.  Pre-launch inventories at June 30, 2012 were comprised of generic products in development.  There was no Strativa-related pre-launch inventory at June 30, 2012.
The amounts in the tables below represent inventories related to products that were not yet available to be sold and are

14


also included in the total inventory balances presented above.

Pre-Launch Inventories

($ amounts in thousands)
 
June 30,
2012
 
December 31,
2011
Raw materials and supplies
$
6,257

 
$
7,774

Work-in-process
315

 
346

Finished goods
1,342

 
631

 
$
7,914

 
$
8,751


Write-offs of pre-launch inventories

($ amounts in thousands)
 
Three months ended
 
Six months ended
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Pre-launch inventory write-offs, net of
     partner allocation
$
5,547

 
$

 
$
6,507

 
$


Note 8 – Property, Plant and Equipment, net:

($ amounts in thousands)
 
June 30,
2012
 
December 31,
2011
Land
$
3,985

 
$
1,882

Buildings
29,879

 
28,186

Machinery and equipment
72,000

 
66,237

Office equipment, furniture and fixtures
7,526

 
6,908

Computer software and hardware
49,432

 
48,198

Leasehold improvements
27,198

 
27,203

Construction in progress
9,390

 
8,032

 
199,410

 
186,646

Accumulated depreciation and amortization
(97,037
)
 
(88,856
)
 
$
102,373

 
$
97,790


Depreciation and amortization expense related to property, plant and equipment

($ amounts in thousands)
 
Three months ended
 
Six months ended
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Depreciation and amortization expense
$
4,479

 
$
3,127

 
$
8,859

 
$
6,264


Note 9 - Intangible Assets, net:

($ amounts in thousands)

15


 
June 30,
2012
 
December 31,
2011
In-process research and development acquired in the Anchen Acquisition, net of
    accumulated amortization of $0 and $0
$
124,700

 
126,700

Developed products acquired in the Anchen Acquisition, net of accumulated amortization
of $13,036 and $1,650
72,164

 
83,550

QOL Medical, LLC Asset Purchase Agreement, net of accumulated amortization of
$14,820 and $12,540
39,901

 
42,181

Teva Pharmaceuticals, Inc. Asset Purchase Agreement, net of accumulated amortization
of $2,664 and $1,255
15,336

 
16,745

Glenmark Generics Limited and Glenmark Generics, Inc. USA Licensing Agreement, net
    of accumulated amortization of $0 and $0
15,000

 
15,000

Synthon Pharmaceuticals, Inc. Asset Purchase Agreement, net of accumulated
    amortization of $0 and $0
9,600

 
9,600

Covenant not-to-compete acquired in the Anchen Acquisition, net of accumulated
amortization of $1,842 and $358
7,059

 
8,542

Teva Pharmaceuticals, Inc. License and Distribution Agreement, net of accumulated
amortization of $4,000 and $0
2,000

 
6,000

In-process research and development acquired in the Edict Acquisition, net of
accumulated amortization of $0
1,100

 

    Genpharm, Inc. Distribution Agreement, net of accumulated amortization of $10,109
        and $9,748
724

 
1,085

Covenant not-to-compete acquired in the Edict Acquisition, net of accumulated
    amortization of $94
656

 

SVC Pharma LP License and Distribution Agreement, net of accumulated amortization
of $3,278 and $3,034
406

 
650

Other intangible assets, net of accumulated amortization of $7,231 and $7,209
391

 
414

Trademark licensed from Bristol-Myers Squibb Company, net of accumulated
amortization of $10,000 and $9,148

 
852

MDRNA, Inc. Asset Purchase Agreement, net of accumulated amortization of $2,100
      and $1,750

 
350

 
$
289,037

 
$
311,669

 
We recorded amortization expense related to intangible assets of $22,482 thousand for the six months ended June 30, 2012 and $6,118 thousand for the six months ended June 30, 2011.  The majority of this amortization expense was included in cost of goods sold.  
On November 17, 2011, Par completed the Anchen Acquisition.  Refer to Note 2, “Anchen Acquisition” for details of the transaction.  As part of the Anchen Acquisition, we acquired intangible assets related to IPR&D, products derived from developed technology, and a covenant not to compete from a former Anchen securityholder and employee.  
The value of in-process research and development acquired in the Anchen Acquisition was capitalized and accounted for as an indefinite-lived intangible asset and will be subject to impairment testing until the completion or abandonment of each project.  Upon successful completion and launch of each project, we will make a separate determination of useful life of the IPR&D intangible.  Amortization expense of the related intangible assets will commence when each product is launched. During the six months ended June 30, 2012, we abandoned an in-process research and development project acquired in the Anchen Acquisition and recorded an intangible asset impairment of $2,000 thousand.    
On October 18, 2011, we announced that we acquired rights to three products from Teva Pharmaceuticals in connection with Teva’s acquisition of Cephalon.  Under terms of the agreements, Par owns the ANDAs of fentanyl citrate lozenges, a generic version of Actiq®, and cyclobenzaprine ER capsules, the generic version of Amrix®, as well as the U.S. rights to market modafinil tablets, the generic version of Provigil®.  Par began shipping to the trade all strengths of fentanyl citrate lozenges shortly after the acquisition.  Par began shipping to the trade all strengths of modafinil tablets in April 2012. Cyclobenzaprine ER capsules and modafinil tablets were not previously marketed by Teva.  We paid $24,000 thousand to acquire fentanyl citrate lozenges and modafinil tablets.  We would also be obligated to pay up to an additional $1,000 thousand milestone upon the launch of cyclobenzaprine ER capsules depending on timing of our launch.  In April 2012, Cephalon, a subsidiary of Teva Pharmaceutical Industries Ltd., won an appeal in the US Court of Appeals for the Federal Circuit in Washington reversing a lower court decision to invalidate Cephalon’s existing patents covering cyclobenzaprine ER capsules, which expire in 2023 and 2025.   We allocated the $24,000 thousand paid for fentanyl citrate lozenges ($18,000 thousand) and

16


for modafinil tablets ($6,000 thousand) based on expected future cash flows.  The remaining net book value of the intangible asset related to fentanyl citrate lozenges ($15,336 thousand) will be amortized over approximately five years.  Amortization expense of the intangible asset related to modafinil tablets commenced when the product was launched in April 2012.
 
Estimated Amortization Expense for Existing Intangible Assets at June 30, 2012
The following table does not include estimated amortization expense for future milestone payments that may be paid and result in the creation of intangible assets after June 30, 2012.

($ amounts in thousands)
 
 
Estimated Amortization Expense
2012
 
$
15,820

2013
 
33,711

2014
 
47,304

2015
 
44,602

2016
 
39,691

2017 and thereafter
 
107,909

 
 
$
289,037


As of June 30, 2012, we determined through our evaluation that intangible assets were recoverable.  

Note 10 - Goodwill:

($ amounts in thousands)
 
June 30,
2012
 
December 31, 2011
Kali Laboratories, Inc.
$
63,729

 
$
63,729

Anchen Acquisition
215,917

 
219,703

Edict Acquisition
29,905

 

 
$
309,551

 
$
283,432


In 2004, we acquired all of the capital stock of Kali Laboratories, Inc., a generic pharmaceutical research and development company, for approximately $142,800 thousand in cash and warrants to purchase 150,000 shares of our common stock valued at approximately $2,500 thousand.  The acquisition resulted in goodwill, which was allocated to Par.
As noted in Note 2, “Anchen Acquisition,” in 2011 we acquired Anchen for $412,753 thousand in aggregate consideration. This goodwill was allocated to Par. During the second quarter of 2012, we collected $3,786 thousand as a result of post-closing adjustments with the former Anchen securityholders and adjusted goodwill associated with the Anchen Acquisition as of June 30, 2012.
As noted in Note 3, “Edict Acquisition,” on February 17, 2012 we acquired Edict, now renamed Par Formulations Private Limited, for $36,600 thousand in aggregate consideration.  This goodwill was allocated to Par.  
In accordance with FASB ASC 350-20-35-30, goodwill is not being amortized, but is tested at least annually, on or about December 31st or whenever events or changes in business circumstances necessitate an evaluation for impairment using a fair value approach.  The goodwill impairment test consists of a two-step process.  The first step is to identify a potential impairment and the second step measures the amount of impairment, if any.  Goodwill is deemed to be impaired if the carrying amount of a reporting unit exceeds its estimated fair value.     
The FASB has issued ASU 2011-8, Intangibles—Goodwill and Other (Topic 350): Testing Goodwill for Impairment.  This amendment of Codification will allow an entity to first assess qualitative factors to determine whether it is necessary to perform the two-step quantitative goodwill impairment test.  Under this amendment, an entity would not be required to calculate the fair value of a reporting unit unless the entity determines, based on a qualitative assessment, that it is more likely than not that its fair value is less than its carrying amount.  The amendment includes a number of examples of events and circumstances for an entity to consider in conducting the qualitative assessment.  This amendment to the Codification is effective for annual and interim goodwill impairment tests performed for fiscal years beginning after December 15, 2011.

17



Note 11 - Income Taxes:

 
Three months ended
 
Six months ended
($ in thousands)
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Provision (benefit) for income taxes
$
28,537

 
$
8,859

 
$
33,062

 
$
(20,587
)
Effective tax rate
36
%
 
49
%
 
59
%
 
17
%

The effective tax rate for the three months ended June 30, 2012 reflects our estimate of our portion of the annual pharmaceutical manufacturer fee under the Patient Protection and Affordable Care Act, offset by benefit for tax deductions specific to U.S. domestic manufacturing companies. The effective tax rate for the six months ended June 30, 2012 reflects our estimate of the portion of loss contingencies which may not be tax deductible and by non-deductibility of our portion of the annual pharmaceutical manufacturer fee under the Patient Protection and Affordable Care Act, offset by benefit for tax deductions specific to U.S. domestic manufacturing companies.   Current deferred income tax assets at June 30, 2012 consisted of temporary differences primarily related to accounts receivable reserves, accrued legal settlements and net operating loss carryforwards.  Non-current deferred income tax liabilities at June 30, 2012 consisted of timing differences primarily related to intangible assets, stock options and depreciation.
Our recently acquired entity, Anchen, is currently being audited by the IRS for the tax years 2007 to 2009.  We are no longer subject to IRS audit for periods prior to 2007.  Anchen is also currently under audit in three state jurisdictions for the years 2005 to 2010.  We are also currently under audit in one additional state jurisdiction for the years 2003 through 2006.  In most other state jurisdictions, we are no longer subject to examination by state tax authorities for years prior to 2007.
We reflect interest and penalties attributable to income taxes, to the extent they arise, as a component of income tax provision or benefit.
The difference between a tax position taken or expected to be taken in a tax return and the benefit recognized and measured pursuant to FASB ASC 740-10 Income Taxes represents an unrecognized tax benefit.  An unrecognized tax benefit is a liability that represents a potential future obligation to the taxing authorities.  As of June 30, 2012, we had $21,342 thousand included in “Long-term liabilities” and $949 thousand in “Accrued expenses and other current liabilities” on the condensed consolidated balance sheet that represented unrecognized tax benefits, interest and penalties based on evaluation of tax positions.  

Note 12 - Senior Credit Facility:

($ amounts in thousands)
 
June 30,
2012
 
December 31,
2011
Term Loan Facility
$
336,875

 
$
345,625

Revolving Credit Facility

 

 
336,875

 
345,625

Less current portion
(30,625
)
 
(21,875
)
Long-term debt
$
306,250

 
$
323,750


In connection with our acquisition of Anchen, a privately-held specialty pharmaceutical company, we entered into a credit agreement (the "Credit Agreement") with a syndicate of banks, led by JPMorgan Chase Bank, N.A., as Administrative Agent, U.S. Bank National Association and PNC Bank, National Association as Co-Syndication Agents, DnB NOR Bank ASA and SunTrust Bank as Co-Documentation Agents, J.P. Morgan Securities LLC as Sole Bookrunner, and J.P. Morgan Securities LLC, U.S. Bank National Association and PNC Bank Capital Markets LLC as Joint Lead Arrangers, to provide senior credit facilities to be comprised of a five-year Term Loan Facility in an initial aggregate principal amount of $350,000 thousand and a five-year Revolving Credit Facility in an initial amount of $100,000 thousand.  We used the proceeds of the Term Loan Facility, together with cash on hand, to finance our acquisition of Anchen, and the proceeds of the Revolving Credit Facility are available for general corporate purposes.  
The Credit Agreement contains customary representations and warranties, as well as customary events of default, in certain cases subject to reasonable and customary periods to cure, including but not limited to: failure to make payments when

18


due, breach of covenants, breach of representations and warranties, insolvency proceedings, certain judgments and attachments and any change of control.   The Credit Agreement also contains various customary covenants that, in certain instances, restrict our ability to: (i) incur additional indebtedness; (ii) create liens on assets; (iii) engage in acquisitions of other companies, products or product lines or mergers or consolidations; (iv) engage in dispositions of assets; (v) make investments, loans, guarantees or advances in or to other companies; (vi) pay dividends and distributions or repurchase capital stock; (vii) enter into sale and leaseback transactions; (viii) engage in transactions with affiliates; and (ix) change the nature of our business.  In addition, the Credit Agreement requires us to maintain the following financial covenants: (a) a maximum leverage ratio, and (b) a minimum fixed charge coverage ratio.  While initially unsecured, we could be obligated to secure our obligations under the Credit Agreement should our leverage ratio exceed a predetermined threshold for two consecutive quarters.  We were in compliance with all financial covenants as of June 30, 2012.  All obligations under the Credit Agreement are guaranteed by our material domestic subsidiaries, including Par Pharmaceutical, Inc., Anchen Incorporated, and Anchen Pharmaceuticals, Inc.  
The interest rates payable under the Credit Agreement is based on defined published rates plus an applicable margin.  During the six months ended June 30, 2012, the effective interest rate on the five-year Term Loan Facility was approximately 2.8%.  We are obligated to pay a commitment fee based on the unused portion of the Revolving Credit Facility.  The Credit Agreement includes an accordion feature pursuant to which we are able to increase the amount available to be borrowed by up to an additional $150,000 thousand under certain circumstances.  Repayments of the proceeds of the Term Loan Facility are due in quarterly installments over the term of the Credit Agreement.  Amounts borrowed under the Revolving Credit Facility would be payable in full upon expiration of the Agreement.  The Credit Agreement expires in five years.  Based on the variable interest rate associated with the Term Loan Facility, its carrying value approximated its fair value at June 30, 2012.

Debt Maturities as of June 30, 2012
 
($ amounts in thousands)
2012
 
$
13,125

2013
 
39,375

2014
 
56,875

2015
 
96,250

2016
 
131,250

Total debt at June 30, 2012
 
$
336,875


Note 13 - Changes in Stockholders’ Equity:
Changes in our Common Stock, Additional Paid-In Capital and Accumulated Other Comprehensive Income accounts during the six-month period ended June 30, 2012 were as follows (share amounts and $ amounts in thousands):

 
Common Stock
 
 
 
 
 
Shares
 
Amount
 
Additional Paid-In Capital
 
Accumulated Other Comprehensive Income
Balance, December 31, 2011
39,678

 
$
397

 
$
389,166

 
$
13

Unrealized income on available for sale securities, net of tax

 

 

 
24

Exercise of stock options
224

 
2

 
5,434

 

Net excess tax benefit from share-based compensation

 

 
4,403

 

Issuance of common stock under the Employee Stock
   Purchase Program

 

 
172

 

Forfeitures of restricted stock
(10
)
 

 

 

Issuances of restricted stock
98

 
1

 
(1
)
 

Compensatory arrangements (a)

 

 
4,709

 

Balance, June 30, 2012
39,990

 
$
400

 
$
403,883

 
$
37


(a)
Share-based compensation expense includes equity-settled awards only.

In September 2007, our Board of Directors approved an expansion of our share repurchase program allowing for the repurchase of up to $75 million of our common stock.  The repurchases may be made, subject to compliance with applicable

19


securities laws, from time to time in the open market or in privately negotiated transactions.  Shares of common stock acquired through the repurchase program are and will be available for general corporate purposes.  We repurchased 1,643 thousand shares of our common stock for approximately $31.4 million pursuant to the expanded program in 2007.  We did not repurchase any shares of common stock under this authorization in 2008, 2009, 2010, 2011 or the year-to-date period of 2012. The authorized amount remaining for stock repurchases under the repurchase program was $43.6 million, as of June 30, 2012. The repurchase program has no expiration date, but would end if our common stock is delisted and we deregister as a public company. For more information, please see our Current Report on Form 8-K, filed July 16, 2012 and our Preliminary Proxy Statement on Schedule 14A, expected to be filed on or about August 2, 2012.

Note 14 - Earnings Per Share:
The following is a reconciliation of the amounts used to calculate basic and diluted earnings per share (share amounts and $ amounts in thousands, except per share amounts):

 
Three months ended
 
Six months ended
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Income (loss) from continuing operations
$
51,305

 
$
9,180

 
$
22,609

 
$
(99,664
)
Provision for income taxes from discontinued operations
28

 
127

 
55

 
253

Loss from discontinued operations
(28
)
 
(127
)
 
(55
)
 
(253
)
Net income (loss)
$
51,277

 
$
9,053

 
$
22,554

 
$
(99,917
)
Basic:
 
 
 
 
 
 
 
Weighted average number of common shares outstanding
36,478

 
35,983

 
36,392

 
35,742

Income (loss) from continuing operations
$
1.41

 
$
0.26

 
$
0.62

 
$
(2.79
)
Loss from discontinued operations

 
(0.01
)
 

 
(0.01
)
Net income (loss) per share of common stock
$
1.41

 
$
0.25

 
$
0.62

 
$
(2.80
)
Assuming dilution:
 
 
 
 
 
 
 
Weighted average number of common shares outstanding
36,478

 
35,983

 
36,392

 
35,742

Effect of dilutive securities
716

 
725

 
730

 

Weighted average number of common and common
   equivalent shares outstanding
37,194

 
36,708

 
37,122

 
35,742

Income (loss) from continuing operations
$
1.38

 
$
0.25

 
$
0.61

 
$
(2.79
)
Loss from discontinued operations

 

 

 
(0.01
)
Net income (loss) per share of common stock
$
1.38

 
$
0.25

 
$
0.61

 
$
(2.80
)
 
Outstanding options of 1,059 thousand as of June 30, 2012 and 774 thousand as of June 30, 2011 were not included in the computation of diluted earnings per share because their exercise prices were greater than the average market price of our common stock during the respective periods and their inclusion would, therefore, have been anti-dilutive.  Since we had a net loss for the six-month period ended June 30, 2011, basic and diluted net loss per share of common stock is the same, because the effect of including potential common stock equivalents (such as stock options, restricted shares, and restricted stock units) would be anti-dilutive.  The effect of dilutive securities would have been 813 thousand on weighted average number of common shares outstanding for the six months ended June 30, 2011.

Note 15 - Share-Based Compensation:
We account for share-based compensation as required by FASB ASC 718-10 Compensation – Stock Compensation, which requires companies to recognize compensation expense in the amount equal to the fair value of all share-based payments granted to employees.  Under FASB ASC 718-10, we recognize share-based compensation ratably over the service period applicable to the award.  FASB ASC 718-10 also requires that excess tax benefits be reflected as financing cash flows.    
We grant share-based awards under our various plans, which provide for the granting of non-qualified stock options, restricted stock and restricted stock units to members of our Board of Directors and to our employees.  Stock options, restricted stock and restricted stock units generally vest ratably over four years or sooner and stock options have a maximum term of ten years.   
On May 17, 2012, our stockholders approved the 2012 Omnibus Incentive Plan (the "omnibus plan"), which reserves a pool of awards equal to the sum of 6.5 million shares, plus any shares added to the omnibus plan related to an award granted

20


under the prior plans that expires, is forfeited or is terminated. Each stock option or stock appreciation right granted will count as one share against the omnibus plan and all other grants will count as 1.75 shares against the omnibus plan share reserve. We issue new shares of common stock when stock option awards are exercised.  Stock option awards outstanding under our current plans were granted at exercise prices that were equal to the market value of our common stock on the date of grant. At June 30, 2012, approximately 6.5 million shares remain available under the omnibus plan for stock option, restricted stock and restricted stock unit and other permitted grants.

Stock Options
We use the Black-Scholes stock option pricing model to estimate the fair value of stock option awards with the following weighted average assumptions:

 
Three months ended
 
Six months ended
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Risk-free interest rate
0.8
%
 
%
 
0.8
%
 
2.2
%
Expected life (in years)
4.7

 

 
4.7

 
5.2

Expected volatility
42.8
%
 
%
 
43.9
%
 
44.6
%
Dividend
%
 
%
 
%
 
%

The Black-Scholes stock option pricing model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable.  We have three distinct populations of optionees; the Executive Officers Group, the Outside Directors Group, and the All Others Group.  The expected life of options represents the period of time that the options are expected to be outstanding (that is, the period of time from the service inception date to the date of expected exercise or other expected settlement) and is based generally on historical trends.  Our expected life weighted average assumption is based on an actuarial study derived from historical exercise data.  The risk-free rate is based on the yield on the Federal Reserve treasury rate with a maturity date corresponding to the expected term of the option granted.  The expected volatility assumption is based on the historical volatility of our common stock over a term equal to the expected term of the option granted.  FASB ASC 718-10 also requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.  It is assumed that no dividends will be paid during the entire term of the options.  All option valuation models require input of highly subjective assumptions.  Because our employee stock options have characteristics significantly different from those of traded options, and because changes in subjective input assumptions can materially affect the fair value estimate, the actual value realized at the time the options are exercised may differ from the estimated values computed above.  
The following is a summary of the weighted average per share fair value of options granted in the six-month periods ended June 30, 2012 and June 30, 2011.

 
Three months ended
 
Six months ended
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Weighted average per share fair value of options granted
$
13.48

 
$

 
$
12.46

 
$
15.42

 
Set forth below is the impact on our results of operations of recording share-based compensation from stock options for the six-month periods ended June 30, 2012 and June 30, 2011 ($ amounts in thousands):

 
Three months ended
 
Six months ended
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Cost of goods sold
$
97

 
$
910

 
$
200

 
$
2,253

Selling, general and administrative
871

 
101

 
1,800

 
250

Total, pre-tax
$
968

 
$
1,011

 
$
2,000

 
$
2,503

Tax effect of share-based compensation
(358
)
 
(384
)
 
(740
)
 
(951
)
Total, net of tax
$
610

 
$
627

 
$
1,260

 
$
1,552



21


The following is a summary of our stock option activity (shares and aggregate intrinsic value in thousands):

 
Shares
 
Weighted Average Exercise Price
 
Weighted Average Remaining Life
 
Aggregate Intrinsic Value
Balance at December 31, 2011
2,286

 
$
30.11

 
 
 
 
Granted
310

 
32.97

 
 
 
 
Exercised
(224
)
 
21.56

 
 
 
 
Forfeited
(28
)
 
29.80

 
 
 
 
Balance at June 30, 2012
2,344

 
$
31.31

 
5.5

 
$
20,774

Exercisable at June 30, 2012
1,519

 
$
33.35

 
4.1

 
$
13,619

Vested and expected to vest at June 30, 2012
2,314

 
$
31.31

 
5.5

 
$
20,617


Total fair value of shares vested ($ amounts in thousands):

 
Three months ended
 
Six months ended
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Total fair value of shares vested
$
63

 
$
173

 
$
3,120

 
$
3,928


As of June 30, 2012, the total compensation cost related to all non-vested stock options granted to employees but not yet recognized was approximately $7.6 million net of estimated forfeitures.  This cost will be amortized on a straight-line basis over the remaining weighted average vesting period of 2.6 years.   

Restricted Stock/Restricted Stock Units
Outstanding restricted stock and restricted stock units generally vest ratably over four years.  The related share-based compensation expense is recorded over the requisite service period, which is the vesting period.  The fair value of restricted stock is based on the market value of our common stock on the date of grant.  
The impact on our results of operations of recording share-based compensation from restricted stock for the six-month periods ended June 30, 2012 and June 30, 2011 was as follows ($ amounts in thousands):

 
Three months ended
 
Six months ended
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Cost of goods sold
$
118

 
$
1,265

 
$
245

 
$
2,772

Selling, general and administrative
1,062

 
140

 
2,207

 
308

Total, pre-tax
$
1,180

 
$
1,405

 
$
2,452

 
$
3,080

Tax effect of stock-based compensation
(437
)
 
(534
)
 
(907
)
 
(1,170
)
Total, net of tax
$
743

 
$
871

 
$
1,545

 
$
1,910

 
The following is a summary of our restricted stock activity (shares and aggregate intrinsic value in thousands):

 
Shares
 
Weighted Average Grant Price
 
Aggregate Intrinsic Value
Non-vested balance at December 31, 2011
281

 
$
24.28

 
 
Granted
99

 
32.89

 
 
Vested
(128
)
 
21.90

 
 
Forfeited
(10
)
 
32.00

 
 
Non-vested balance at June 30, 2012
242

 
$
28.73

 
$
8,736


The following is a summary of our restricted stock unit activity (shares and aggregate intrinsic value in thousands):

22



 
Shares
 
Weighted Average Grant Price
 
Aggregate Intrinsic Value
Non-vested restricted stock unit balance at December 31, 2011
69

 
$
36.47

 
 
Granted
79

 
32.97

 
 
Vested
(24
)
 
36.16

 
 
Forfeited

 

 
 
Non-vested restricted stock unit balance at June 30, 2012
124

 
$
34.30

 
$
4,496

Vested awards not issued
193

 
$
24.05

 
$
6,950

Total restricted stock unit balance at June 30, 2012
317

 
$
28.07

 
$
11,446


As of June 30, 2012, the total compensation cost related to all non-vested restricted stock and restricted stock units (excluding restricted stock grants with market conditions described below) granted to employees but not yet recognized was approximately $8.2 million, net of estimated forfeitures; this cost will be amortized on a straight-line basis over the remaining weighted average vesting period of approximately 2.6 years.  

Cash-settled Restricted Stock Unit Awards
We grant cash-settled restricted stock unit awards that vest ratably over four years to certain employees.  The cash-settled restricted stock unit awards are classified as liability awards and are reported within accrued expenses and other current liabilities and other long-term liabilities on the condensed consolidated balance sheet.  Cash settled restricted stock units entitle such employees to receive a cash amount determined by the fair value of our common stock on the vesting date.  The fair values of these awards are remeasured at each reporting period (mark-to-market) until the awards vest and are paid.  Fair value fluctuations are recognized as cumulative adjustments to share-based compensation expense and the related liabilities.  Cash-settled restricted stock unit awards are subject to forfeiture if employment terminates prior to vesting.  Share-based compensation expense for cash-settled restricted stock unit awards are recognized ratably over the service period.  Cash-settled restricted stock unit awards do not decrease shares available for future share-based compensation grants.
The impact on our results of operations of recording share-based compensation from cash-settled restricted stock units for the six-month periods ended June 30, 2012 and June 30, 2011 was as follows ($ amounts in thousands):

 
Three months ended
 
Six months ended
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Cost of goods sold
$
48

 
$
257

 
$
132

 
$
934

Selling, general and administrative
432

 
28

 
1,190

 
104

Total, pre-tax
$
480

 
$
285

 
$
1,322

 
$
1,038

Tax effect of stock-based compensation
(178
)
 
(108
)
 
(489
)
 
(394
)
Total, net of tax
$
302

 
$
177

 
$
833

 
$
644

 
Information regarding activity for cash-settled restricted stock units outstanding is as follows (number of awards in thousands):
 
Number of Awards
 
Weighted Average Grant Date Fair Value
 
Aggregate Intrinsic Value
Awards outstanding at December 31, 2011
149

 
$
32.97

 
 
Granted
137

 
33.37

 
 
Vested
(38
)
 
32.55

 
 
Forfeited
(14
)
 
32.04

 
 
Awards outstanding at June 30, 2012
234

 
$
33.33

 
$
8,471

 
As of June 30, 2012, unrecognized compensation costs related to non-vested cash-settled restricted stock units was approximately $6.5 million, net of estimated forfeitures.  This cost will be amortized on a straight-line basis over the remaining vesting period of approximately 3.0 years.

23



Employee Stock Purchase Program:
We maintain an Employee Stock Purchase Program (the “Program”).  The Program is designed to qualify as an employee stock purchase plan under Section 423 of the Internal Revenue Code of 1986, as amended.  It enables eligible employees to purchase shares of our common stock at a 5% discount to the fair market value.  An aggregate of 1.0 million shares of common stock has been reserved for sale to employees under the Program.  At June 30, 2012, approximately 700 thousand shares remain available under the Program.

(amounts in thousands)
 
Three months ended
 
Six months ended
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Shares purchased by employees
3

 
3

 
5

 
6


Chief Executive Officer Specific Share-based Compensation
On November 2, 2010, we entered into a new employment agreement with Patrick LePore, in his capacity as President and Chief Executive Officer, effective as of January 1, 2011.  His new employment agreement is for a three-year term, ending December 31, 2013, subject to certain early termination events.  Pursuant to the employment agreement, Mr. LePore is eligible to receive an incentive compensation award based on the compound annual growth rate (“CAGR”) of our common stock over the course of Mr. LePore’s three-year employment term (January 1, 2011 to December 31, 2013).  Mr. LePore will be eligible to receive an incentive compensation award ranging from $2 million (for a three-year CAGR of 4%) to $9 million (for a three-year CAGR of 20% or more).  He will not be eligible to receive an incentive compensation award if the Company’s three-year CAGR is below 4%, and no incentive compensation award will be payable if the employment agreement is terminated prior to its expiration unless a change of control (as defined in the agreement) has occurred.  These CAGR based awards will be classified as liability awards and are reported within accrued expenses and other current liabilities and other long-term liabilities on the condensed consolidated balance sheet.  The fair values of these awards are remeasured at each reporting period (mark-to-market) using a Monte Carlo valuation model until the awards vest and are paid.  Fair value fluctuations are recognized as cumulative adjustments to share-based compensation expense and the related liabilities.  Share-based compensation expense for these CAGR awards will be recognized ratably over the three-year service period.  From January 1, 2011 through June 30, 2012, we recognized $749 thousand of expense associated with this plan.  
In January 2011, Mr. LePore was granted an equity award consisting of restricted stock units with a total grant date economic value of approximately $1.85 million.  The units will vest on the earlier of (a) the expiration of Mr. LePore’s employment term on December 31, 2013, (b) the date that a change of control (as defined in the agreement) occurs, or (c) the date of an eligible earlier termination of Mr. LePore’s employment term in accordance with the provisions of the agreement.  The related share-based compensation expense is being recorded over the three-year term of the new employment agreement, which is the vesting period.  The fair value of restricted stock units was based on the market value of our common stock on the date of grant.

Note 16 - Commitments, Contingencies and Other Matters:
Legal Proceedings
Unless otherwise indicated in the details provided below, we cannot predict with certainty the outcome or the effects of the litigations described below.  The outcome of these litigations could include substantial damages, the imposition of substantial fines, penalties, and injunctive or administrative remedies; however, unless otherwise indicated below, at this time we are not able to estimate the possible loss or range of loss, if any, associated with these legal proceedings.  From time to time, we may settle or otherwise resolve these matters on terms and conditions that we believe are in the best interests of the Company.  Resolution of any or all claims, investigations, and legal proceedings, individually or in the aggregate, could have a material effect on our results of operations, cash flows or financial condition.  

Corporate Litigation
We and certain of our former executive officers have been named as defendants in consolidated class action lawsuits filed on behalf of purchasers of our common stock between July 23, 2001 and July 5, 2006.  The lawsuits followed our July 5, 2006 announcement regarding the restatement of certain of our financial statements and allege that we and certain members of our then management engaged in violations of the Exchange Act, by issuing false and misleading statements concerning our financial condition and results of operations.  The consolidated class actions are pending in the U.S. District Court for the District of New Jersey.  On July 23, 2008, co-lead plaintiffs filed a Second Consolidated Amended Complaint.  On September

24


30, 2009, the Court granted a motion to dismiss all claims as against Kenneth Sawyer but denied the motion as to the Company, Dennis O’Connor, and Scott Tarriff.  The co-lead plaintiffs filed a motion to certify the class.  After class discovery, both co-lead plaintiffs withdrew and a new lead plaintiff, Louisiana Municipal Police Employees Retirement Fund (LAMPERS) and its counsel, Berman DeValerio, were substituted in as lead plaintiff and new lead counsel.  LAMPERS filed a motion for class certification, which was granted by the Court on July 23, 2012.  We and Messrs. O'Connor and Tarriff have answered the amended complaint and intend to vigorously defend the consolidated class action.
Between July 24 and July 30, 2012 we, certain of our current directors, TPG Capital L.P. (“TPG Capital”), Sky Growth Holding Corporation (“Sky Holding”), and Sky Growth Acquisition Corporation (“Sky Growth”) (collectively, TPG Capital, Sky Holding, and Sky Growth, shall be referred to as “TPG”) were named as defendants in five class action lawsuits brought by and on behalf of current owners of our common stock. These lawsuits are captioned Nadoff v. Par Pharmaceutical Companies, Inc., et al., C.A. No. 7715-VCP (Del. Ch.), KBC Asset Management N.V. v. Par Pharmaceutical Companies, et al., C.A. No. 7725-VCP (Del. Ch.), Greenberg v. Knight, et al., C.A. No. 7734-VCP (Del. Ch.), Duvall v. Par Pharmaceutical Companies, Inc., et al. No. C-226-12 (N.J. Super. Ct. Ch. Div.) and Wilkinson v. LePore, et al., No. C-229-12 (N.J. Super. Ct. Ch. Div.). These lawsuits follow our July 16, 2012 announcement that we and TPG entered into an Agreement and Plan of Merger (the “Merger Agreement”), pursuant to which TPG will acquire the Company, subject to customary closing conditions including Par stockholder approval.  The lawsuits each allege that the Company's directors have breached their fiduciary duties to the Company's stockholders in connection with the merger. The lawsuits further claim that TPG aided and abetted the directors' alleged breaches of fiduciary duties. The Greenberg and Wilkinson actions also assert an aiding and abetting claim against the Company.  The lawsuits generally seek equitable relief, including an injunction preventing the consummation of the merger, rescission in the event the merger is consummated, invalidation or amendment of deal protections, and an award of attorneys' and other fees and costs. More complaints may be filed going forward. The Company and its directors believe that the claims in each of these lawsuits are without merit, and intend to vigorously defend all pending claims.

Patent Related Matters
On April 28, 2006, CIMA Labs, Inc. and Schwarz Pharma, Inc. filed separate lawsuits against us in the U.S. District Court for the District of New Jersey.  CIMA and Schwarz Pharma each have alleged that we infringed U.S. Patent Nos. 6,024,981 (the “’981 patent”) and 6,221,392 (the “’392 patent”) by submitting a Paragraph IV certification to the FDA for approval of alprazolam orally disintegrating tablets.  CIMA owns the ’981 and ’392 patents and Schwarz Pharma is CIMA’s exclusive licensee.  The two lawsuits were consolidated on January 29, 2007.  In response to the lawsuit, we have answered and counterclaimed denying CIMA’s and Schwarz Pharma’s infringement allegations, asserting that the ’981 and ’392 patents are not infringed and are invalid and/or unenforceable.  On July 10, 2008, the United States Patent and Trademark Office (“USPTO”) rejected all claims pending in both the ‘392 and ‘981 patents.  On September 28, 2009, the USPTO Board of Appeals affirmed the Examiner’s rejection of all claims in the ‘981 patent, and on March 24, 2011, the USPTO Board of Appeals affirmed the rejections pending for both patents and added new grounds for rejection of the ’981 patent.  On June 24, 2011, the plaintiffs re-opened prosecution on both patents at the USPTO.  We intend to vigorously defend this lawsuit and pursue our counterclaims.
We entered into a licensing agreement with developer Paddock Laboratories, Inc. to market testosterone 1% gel, a generic version of Unimed Pharmaceuticals, Inc.’s product Androgel®.  As a result of the filing of an ANDA, Unimed and Laboratories Besins Iscovesco (“Besins”), co-assignees of the patent-in-suit, filed a lawsuit on August 22, 2003 against Paddock in the U.S. District Court for the Northern District of Georgia alleging patent infringement.  On September 13, 2006, we acquired from Paddock all rights to the ANDA for the testosterone 1% gel, and the litigation was resolved by a settlement and license agreement that terminated all on-going litigation and permits us to launch the generic version of the product no earlier than August 31, 2015, and no later than February 28, 2016, assuring our ability to market a generic version of Androgel® well before the expiration of the patents at issue.  On March 7, 2007, we were issued a Civil Investigative Demand seeking information and documents in connection with the 2006 court-approved settlement of the patent dispute.  On January 30, 2009, the Bureau of Competition for the Federal Trade Commission (“FTC”) filed a lawsuit against us in the U.S. District Court for the Central District of California alleging violations of antitrust laws stemming from our court-approved settlement in the Paddock litigation, and several distributors and retailers followed suit with a number of private plaintiffs’ complaints beginning in February 2009.  On April 9, 2009, the U.S. District Court for the Central District of California granted our motion to transfer the FTC lawsuit and the private plaintiffs’ complaints to the U.S. District Court for the Northern District of Georgia.  On February 23, 2010, the District Court granted our motion to dismiss the FTC’s claims and granted in part and denied in part our motion to dismiss the claims of the private plaintiffs.  On June 10, 2010, the FTC appealed the District Court’s dismissal of the FTC’s claims to the U.S. Court of Appeals for the 11th Circuit.  On April 25, 2012, the Court of Appeals affirmed the District Court’s dismissal of the FTC’s claims.  On January 20, 2012, we filed a motion for summary judgment in our lawsuit against the private plaintiffs in the U.S. District Court for the Northern District of Georgia seeking to have their claims of sham litigation dismissed.  We believe we have complied with all applicable laws in connection with the court-approved settlement and intend to continue to vigorously defend these actions.

25


On November 10, 2011, Celgene and Novartis filed a lawsuit against us in the U.S. District Court for the District of New Jersey, and Alkermes plc (formerly Elan) filed a lawsuit against us in the U.S. District Court for the District of Delaware the following day.  The complaint in the Delaware case alleged infringement of U.S. Patent Nos. 6,228,398 and 6,730,325 because we submitted a Paragraph IV certification to the FDA for approval of 5, 10, 15, 20, 25, 30, and 35 mg dexmethylphenidate hydrochloride extended release capsules.  The complaint in the New Jersey case alleged infringement of U.S. Patent Nos. 5,908,850; 6,355,656; 6,528,530; 5,837,284; 6,635,284; and 7,431,944 because we submitted a Paragraph IV certification to the FDA for approval of 5, 10, 15, 20, 25, 30, 35, and 40 mg dexmethylphenidate extended release capsules.  We intend to vigorously defend and expeditiously resolve these lawsuits.
On September 13, 2007, Santarus, Inc. and The Curators of the University of Missouri (“Missouri”) filed a lawsuit against us in the U.S. District Court for the District of Delaware.  The complaint alleges infringement of U.S. Patent Nos. 6,699,885; 6,489,346; and 6,645,988 because we submitted a Paragraph IV certification to the FDA for approval of 20 mg and 40 mg omeprazole/sodium bicarbonate capsules.  On December 20, 2007, Santarus and Missouri filed a second lawsuit against us in the U.S. District Court for the District of Delaware alleging infringement of the patents because we submitted a Paragraph IV certification to the FDA for approval of 20 mg and 40 mg omeprazole/sodium bicarbonate powders for oral suspension.  On March 4, 2008, the cases pertaining to our ANDAs for omeprazole capsules and omeprazole oral suspension were consolidated for all purposes.  The District Court conducted a bench trial from July 13-17, 2009, and found for Santarus only on the issue of infringement, while not rendering an opinion on the issues of invalidity and unenforceability.  On April 14, 2010, the District Court ruled in our favor, finding that plaintiffs’ patents were invalid as being obvious and without adequate written description.  On May 17, 2010, Santarus filed a notice of appeal to the U.S. Court of Appeals for the Federal Circuit, appealing the District Court’s decision of invalidity of the plaintiffs’ patents.  On May 27, 2010, we filed our notice of cross-appeal to the Court of Appeals, appealing the District Court’s decision of enforceability of plaintiffs’ patents.  On July 1, 2010, we launched our generic Omeprazole/Sodium Bicarbonate product.  Oral argument for the appeal was held on May 2, 2011.  We will continue to vigorously defend the appeal.
On September 20, 2010, Schering-Plough HealthCare Products, Santarus, Inc., and the Curators of the University of Missouri filed a lawsuit against us in the U.S. District Court for the District of New Jersey.  The complaint alleges infringement of U.S. Patent Nos. 6,699,885; 6,489,346; 6,645,988; and 7,399,772 because we submitted an ANDA with a Paragraph IV certification to the FDA for approval of a 20mg/1100 mg omeprazole/sodium bicarbonate capsule, a version of Schering-Plough’s Zegerid OTC®.  We have previously received a decision of invalidity with respect to all of these patents in our case against Santarus and Missouri with respect to the prescription version of this product, which decision is presently on appeal.  On November 9, 2010, we entered into a stipulation with the plaintiffs to stay litigation on the OTC product pending the decision by the U.S. Court of Appeals for the Federal Circuit on the prescription product appeal, and the parties have agreed to be bound by such decision for purposes of the OTC product litigation.  We intend to pursue our appeal and defend this action vigorously.
On December 11, 2007, AstraZeneca Pharmaceuticals, LP, AstraZeneca UK Ltd., IPR Pharmaceuticals, Inc. and Shionogi Seiyaku Kabushiki Kaisha filed a lawsuit against us in the U.S. District Court for the District of Delaware.  The complaint alleges patent infringement because we submitted a Paragraph IV certification to the FDA for approval of 5 mg, 10 mg, 20 mg and 40 mg rosuvastatin calcium tablets.  On June 29, 2010, after an eight day bench trial, the District Court ruled in favor of the plaintiffs and against us, stating that the plaintiffs’ patents were infringed, and not invalid or unenforceable.  On August 11, 2010, we appealed the District Court’s decision to the U.S. Court of Appeals for the Federal Circuit.  An oral hearing was conducted October 5, 2011, and we await the decision of the Court of Appeals.  On December 15, 2010, the District Court granted our motion to dismiss a second case brought by AstraZeneca, in which AstraZeneca had asserted that we infringed its rosuvastatin process patents, which decision AstraZeneca appealed to the U.S. Court of Appeals for the Federal Circuit on January 14, 2011.  On February 9, 2012, the Court of Appeals affirmed the Delaware District Court’s dismissal of plaintiffs’ claims in the second action.  We intend to defend both actions vigorously.
On November 14, 2008, Pozen, Inc. filed a lawsuit against us in the U.S. District Court for the Eastern District of Texas.  The complaint alleges infringement of U.S. Patent Nos. 6,060,499; 6,586,458; and 7,332,183, because we submitted a Paragraph IV certification to the FDA for approval of 500 mg/85 mg naproxen sodium/sumatriptan succinate oral tablets.  We joined GlaxoSmithKline (“GSK”) as a counterclaim defendant in this litigation.  On April 28, 2009, GSK was dismissed from the case, but will be bound by the Court’s decision and will be required to produce witnesses and materials during discovery.  A four day bench trial was held from October 12-15, 2010.  On April 14, 2011, the Court granted a preliminary injunction to Pozen that prohibits us from launching our generic naproxen/sumatriptan product before the issuance of a final decision in the case.  On August 5, 2011, the Court ruled in favor of Pozen and against us on infringement, validity, and enforceability.  We filed our appeal brief to the U.S. Court of Appeals for the Federal Circuit on August 31, 2011, and our reply brief on January 20, 2012.  On June 5, 2012, the court issued a per curiam affirmance of the lower court's decision not to award attorneys' fees to one of our co-defendants but, in that decision, did not otherwise reach the merits of our appeal. We intend to vigorously pursue our appeal.   
On April 29, 2009, Pronova BioPharma ASA filed a lawsuit against us in the U.S. District Court for the District of

26


Delaware.  The complaint alleges infringement of U.S. Patent Nos. 5,502,077 and 5,656,667 because we submitted a Paragraph IV certification to the FDA for approval of omega-3-acid ethyl esters oral capsules.  A bench trial took place from March 29, 2011 to April 7, 2011.  On September 29, 2011, we filed our final reply brief with the Court.  We intend to continue to defend this action vigorously and pursue our defenses and counterclaims against Pronova.  During the pendency of this action, on June 8, 2010, a new patent, U.S. 7,732,488, which was later listed in the Orange Book, was issued to Pronova, and Pronova filed a second case, asserting claims of the ’488 patent and two other patents not listed in the Orange Book.  On July 25, 2011, a stipulation was submitted to the court dismissing the second case without prejudice. On May 29, 2012, the Delaware court ruled in favor of Pronova on infringement, validity, and enforceability. On June 25, 2012, we filed our notice of appeal to the Court of Appeals for the Federal Circuit and intend to vigorously prosecute this appeal.
On August 5, 2010, Warner Chilcott and Medeva Pharma filed a lawsuit against us and our partner EMET Pharmaceuticals in the U.S. District Court for the District of New Jersey.  The complaint alleges infringement of U.S. Patent No. 5,541,170 because we submitted an ANDA with a Paragraph IV certification to the FDA for approval of a 400 mg delayed-release oral tablet of mesalamine.  On March 29, 2011, the Court granted plaintiffs’ motion to dismiss our counterclaim for declaratory judgment of non-infringement of U.S. Patent No. 5,541,171.  Our appeal of this decision was docketed with the U.S. Court of Appeals for the Federal Circuit on May 20, 2011.  A Markman hearing was held on October 18, 2011.  An oral hearing was conducted on January 12, 2012, and the Court of Appeals affirmed the District Court’s decision on January 27, 2012.  On June 1, 2012, the court issued a Markman opinion in the case construing the definition of key claim terms delimiting active release and coating solubility.  We intend to defend this action vigorously and pursue all of our defenses and counterclaims against Warner Chilcott and Medeva Pharma.
On October 4, 2010, UCB Manufacturing, Inc. filed a verified complaint in the Superior Court of New Jersey, Chancery Division, Middlesex, naming us, our development partner Tris Pharma, and Tris Pharma’s head of research and development, Yu-Hsing Tu.  The complaint alleges that Tris and Tu misappropriated UCB’s trade secrets and, by their actions, breached contracts and agreements to which UCB, Tris, and Tu were bound.  The complaint further alleges unfair competition against Tris, Tu, and us relating to the parties’ manufacture and marketing of generic Tussionex®.  On October 6, 2010, the Court denied UCB’s petition for a temporary restraining order against us and Tris and set a schedule for discovery during which UCB must substantiate its claims.  On December 23, 2010, the Court denied UCB’s motion for a preliminary injunction, ruling that UCB’s alleged trade secrets were known to the public and not misappropriated.  On June 2, 2011, the Court granted Tris’s motion for summary judgment dismissing UCB’s claims, and UCB appealed the Court’s order on June 22, 2011.  We intend to vigorously defend the lawsuit and any appeal by plaintiffs.
On March 25, 2011, Elan Corporation, PLC filed a lawsuit against us and our development partners, IntelliPharmaceutics Corp. and IntelliPharmaCeutics Ltd. (collectively “IPC”) in the U.S. District Court for the District of Delaware, and Celgene Corporation and Novartis filed a lawsuit against IPC in the U.S. District Court for the District of New Jersey.  The complaint in the Delaware case alleges infringement of U.S. Patent Nos. 6,228,398 and 6,730,325 because we submitted a Paragraph IV certification to the FDA for approval of 30 mg dexmethylphenidate hydrochloride extended release capsules.  The complaint in the New Jersey case alleges infringement of U.S. Patent Nos. 6,228,398; 6,730,325; 5,908,850; 6,355,656; 6,528,530; 5,837,284; and 6,635,284 because we submitted a Paragraph IV certification to the FDA for approval of 30 mg dexmethylphenidate extended release capsules.  On July 17, 2012, a stipulation and order to stay the case in Delaware was entered pending regulatory review of a pending settlement between us and the Delaware plaintiffs. We intend to vigorously defend and expeditiously resolve these lawsuits.
On May 27, 2011, Elan Corporation, PLC filed a lawsuit against us in the U.S. District Court for the District of Delaware, and Celgene Corporation and Novartis filed a lawsuit against us in the U.S. District Court for the District of New Jersey.  The complaint in the Delaware case alleges infringement of U.S. Patent Nos. 6,228,398 and 6,730,325 because we submitted a Paragraph IV certification to the FDA for approval of 40 mg dexmethylphenidate hydrochloride extended release capsules.  The complaint in the New Jersey case alleges infringement of U.S. Patent Nos. 6,228,398; 6,730,325; 5,908,850; 6,355,656; 6,528,530; 5,837,284; and 6,635,284 because we submitted a Paragraph IV certification to the FDA for approval of 40 mg dexmethylphenidate extended release capsules.  On July 17, 2012, a stipulation and order to stay the case in Delaware was entered pending regulatory review of a pending settlement between us and the Delaware plaintiffs. We intend to vigorously defend and expeditiously resolve these lawsuits.
On August 10, 2011, Avanir Pharmaceuticals, Inc. et al. filed a lawsuit against us in the U.S. District Court for the District of Delaware.  The complaint alleges infringement of U.S. Patent Nos. 7,659,282 and RE38,155 because we submitted an ANDA with a Paragraph IV certification to the FDA for approval of oral capsules of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate.  We filed our answer on September 6, 2011, and our case was consolidated with those for the other defendants, Actavis, Impax, and Wockhardt, on September 26, 2011.  The Court has scheduled a Markman hearing for October 5, 2012, and a 10-day bench trial for September 9, 2013. On June 15, 2012, the cases of all current generic defendants were consolidated for all purposes. We intend to defend this action vigorously.
On February 2, 2011, Somaxon Pharmaceuticals filed a lawsuit against us in the U.S. District Court for the District of

27


Delaware.  The complaint alleges infringement of U.S. Patent No. 6,211,229 because we submitted an ANDA with a Paragraph IV certification to the FDA for approval of oral tablets of 3 mg equivalent and 6 mg equivalent doxepin hydrochloride.  We filed our answer on February 23, 2011.  Our case has been consolidated in the same Court with those of the other defendants who filed ANDAs on this product.  The Court has scheduled fact discovery to end on April 6, 2012; expert discovery to end on August 17, 2012; the end of Markman briefing for October 12, 2012; and a trial date of December 10, 2012.  On July 17, 2012, Somaxon announced our settlement of the litigation pursuant to a license agreement permitting date certain entry in 2020 or earlier in certain circumstances.
On September 1, 2011, we, along with EDT Pharma Holdings Ltd. (now known as Alkermes Pharma Ireland Limited) (Elan), filed a complaint against TWi Pharmaceuticals, Inc. in the U.S. District Court for the District of Maryland and another complaint against TWi on September 2, 2011, in the U.S. District Court for the Northern District of Illinois.  In both complaints, Elan and we allege infringement of U.S. Patent No. 7,101,576 (expiration April 22, 2024) in view of the notice letter we received from TWi stating that TWi had filed an ANDA, accompanied by a Paragraph IV certification, seeking approval for a generic version of Megace® ES.  We are at present aware of no other generic filers.  On November 15, 2011, the Court scheduled the end of fact discovery for September 1, 2012; the end of expert discovery for December 15, 2012; and a 5-7 day bench trial for October 7, 2013.  We intend to prosecute this infringement case vigorously.
On April 8, 2010, AstraZeneca filed a lawsuit against Anchen Incorporated (now a subsidiary of Par Pharmaceutical, Inc.) in the U.S. District Court for the District of New Jersey.  The complaint alleges infringement of U.S. Patent No. 5,948,437 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of extended-release oral tablets of 150, 200, 300, and 400 mg quetiapine.  A Markman hearing was conducted on November 30, 2010 and a bench trial was held from October 3-19, 2011.  On March 29, 2012, the court ruled in favor of AstraZeneca on invalidity and infringement, enjoining final approval for any generic defendant until May 28, 2017.  While other co-defendants have appealed the decision, we have chosen not to join the appeal.
On June 10, 2010, Genzyme Corporation filed a lawsuit against Anchen in the U.S. District Court for the District of Delaware.  The complaint alleges infringement of U.S. Patent Nos. 5,602,116, and 6,903,083 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of oral capsules of 0.5, 1, and 2.5 mcg doxercalciferol.  A bench trial was conducted from November 14-18, 2011.  On June 11, 2012, the court issued a decision in favor of Sanofi (the acquirer of Genzyme) on infringement and validity. While other co-defendants have appealed, we have chosen not to join the appeal.
On June 14, 2010, Abbott Laboratories and Fournier Laboratories Ireland Ltd. filed a lawsuit against Anchen in the U.S. District Court for the District of New Jersey.  The complaint alleges infringement of U.S. Patent No. 7,259,186 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of delayed-release oral capsules of EQ 45 and EQ 135 mg choline fenofibrate.  On April 18, 2012, the Court entered a stipulation and dismissal of the case.  
On January 12, 2011, GlaxoSmithKline, LLC filed a lawsuit against Anchen in the U.S. District Court for the District of Delaware.  The complaint alleges infringement of U.S. Patent No. 5,565,467 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of an oral capsule of 0.5 mg dutasteride and an oral capsule of 0.5/0.4 mg dutasteride/tamsulosin.  On November 30, 2011, the court confirmed that the bench trial for this case is set for October 22, 2012.  We will continue to defend this action vigorously.
On February 23, 2011, Takeda Pharmaceuticals Co., Ltd., Takeda Pharmaceuticals North America, Inc., Takeda Pharmaceuticals, LLC, and Takeda Pharmaceuticals America, Inc. filed suit against Handa Pharmaceuticals, LLC in the United States District Court for the Northern District of California.  The complaint alleged infringement of U.S. Patent Nos. 6,462,058; 6,664,276; 6,939,971; 7,285,668; and 7,790,755 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of 30 mg and 60 mg dexlansoprazole delayed-release capsules.  On March 12, 2012, we acquired this ANDA under an exclusive acquisition and license agreement, which requires us to manage and fund the on-going patent litigation.  On April 11, 2012, the court issued a claim construction opinion that largely adopted the constructions proposed by plaintiffs.  A trial is scheduled for June 3, 2013.  We intend to vigorously defend this action.
On September 9, 2011, Flamel Technologies, S.A. filed a lawsuit against Anchen in the U.S. District Court for the District of Maryland.  The complaint alleges infringement of U.S. Patent No. 6,022,562 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of extended-release oral capsules of 10, 20, 40, and 80 mg carvedilol.  The complaint was served on us on January 12, 2012, and we filed our answer on January 30, 2012.  On June 5, 2012, the case was dismissed pursuant to stipulation as between the parties, in addition to a stipulation of dismissal of the third party complaint against GlaxoSmithKline.
On October 28, 2011, Astra Zeneca, Pozen, Inc., and KBI-E Inc., filed a lawsuit against Anchen in the U.S. District Court for the District of New Jersey.  The complaint alleges infringement of U.S. Patent No. 6,926,907; 6,369,085; 7,411,070; and 7,745,466 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of delayed-release oral tablets of 375/20 and 500/20 mg naproxen/esomeprazole magnesium.  We filed our answer on December 12, 2011.  On June 11, 2012, our case was consolidated with those of the other standing generic defendants for all purposes. We will continue to

28


defend this action vigorously.  
On March 28, 2012, Horizon Pharma Inc. and Horizon Pharma USA Inc. filed a lawsuit against us in the U.S. District Court for the District of Delaware.  The complaint alleges infringement of U.S. Patent No. 8,067,033 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of oral tablets of 26.6/800 mg famotidine/ibuprofen. On April 26, 2012, we filed our answer and counterclaims. We intend to defend this action vigorously.
On April 4, 2012, AR Holding Company, Inc. filed a lawsuit against us in the U.S. District Court for the District of Delaware.  The complaint alleges infringement of U.S. Patent Nos. 7,619,004; 7,601,758; 7,820,681; 7,915,269; 7,964,647; 7,964,648; 7,981,938; 8,093,296; 8,093,297; and 8,097,655 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of oral tablets of 0.6 mg colchicine.  On April 26, 2012, we filed our answer and counterclaims. We intend to defend this action vigorously.
On April 10, 2012, Depomed Inc. filed a lawsuit against us in the U.S. District Court for the District of New Jersey.  The complaint alleges infringement of U.S. Patent Nos. 6,340,375; 6,488,962; 6,635,280; 6,723,340; 7,438,927; and 7,731,989 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of oral tablets of 300 and 600 mg gabapentin. We filed our answer on May 3, 2012. We intend to defend this action vigorously.
On July 20, 2011, Nautilus Neurosciences, Inc. and APR Applied Pharma Research SA, filed a lawsuit against Edict Pharmaceuticals Pvt. Ltd. (now Par Formulations Pvt. Ltd.) in the U.S. District Court for the District of New Jersey.  The complaint alleges infringement of U.S. Patent Nos. 6,974,595; 7,482,377; and 7,759,394 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of diclofenac potassium for oral solution 50 mg.  We intend to defend this action vigorously.

On June 22, 2012, Pfizer, Inc., Wyeth, LLC et al. filed lawsuits against the Company in the U.S. District Courts for the District of Delaware and the Central District of California. The complaints allege infringement of U.S. Patent No. 6,673,838 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of O-desmethylvenlafaxine succinate extended release tablets 50 mg and 100 mg. We intend to defend this action vigorously.
Industry Related Matters
Beginning in September 2003, we, along with numerous other pharmaceutical companies, have been named as a defendant in actions brought by the Attorneys General of Illinois, Kansas, Louisiana, and Utah, as well as a state law qui tam action brought on behalf of the state of Wisconsin by Peggy Lautenschlager and Bauer & Bach, LLC, alleging generally that the defendants defrauded the state Medicaid systems by purportedly reporting “Average Wholesale Prices” (“AWP”) and/or “Wholesale Acquisition Costs” that exceeded the actual selling price of the defendants’ prescription drugs.  These cases generally seek some combination of actual damages, and/or double damages, treble damages, compensatory damages, statutory damages, civil penalties, disgorgement of excessive profits, restitution, disbursements, counsel fees and costs, litigation expenses, investigative costs, injunctive relief, punitive damages, imposition of a constructive trust, accounting of profits or gains derived through the alleged conduct, expert fees, interest and other relief that the court deems proper.  To date, we have settled the lawsuits brought by the states of Alabama, Alaska, Florida, Hawaii, Idaho, Kentucky, Massachusetts, Mississippi, South Carolina, and Texas, as well as the federal qui tam action brought on behalf of the United States by the pharmacy Ven-A-Care of the Florida Keys, Inc.  On June 2, 2011, we reached a settlement in principle to resolve claims brought by the city of New York, New York Counties and the state of Iowa under respective state law for $23,000 thousand.  On October 18, 2011, we reached an agreement in principle to settle the Oklahoma suit for $884 thousand.  We have accrued a $37,800 thousand reserve under the caption “Accrued legal settlements” on our consolidated balance sheet as of June 30, 2012, in connection with the June 2, 2011 settlement in principle and the remaining AWP actions.  In the Utah suit, the time for responding to the complaint has not yet elapsed.  In each of the remaining matters, we have either moved to dismiss the complaints or answered the complaints denying liability.  We will continue to defend or explore settlement opportunities in other jurisdictions as we feel are in our best interest under the circumstances presented in those jurisdictions.  However, we can give no assurance that we will be able to settle the remaining actions on terms that we deem reasonable, or that such settlements or adverse judgments, if entered, will not exceed the amount of the reserve.
The Attorneys General of Florida, Indiana and Virginia and the United States Office of Personnel Management (the “USOPM”) have issued subpoenas, and the Attorneys General of Michigan, Tennessee, Texas, and Utah have issued civil investigative demands, to us.  The demands generally request documents and information pertaining to allegations that certain of our sales and marketing practices caused pharmacies to substitute ranitidine capsules for ranitidine tablets, fluoxetine tablets for fluoxetine capsules, and two 7.5 mg buspirone tablets for one 15 mg buspirone tablet, under circumstances in which some state Medicaid programs at various times reimbursed the new dosage form at a higher rate than the dosage form being substituted.  We have provided documents in response to these subpoenas to the respective Attorneys General and the USOPM.  The aforementioned subpoenas and civil investigative demands culminated in the federal and state law qui tam action brought on behalf of the United States and several states by Bernard Lisitza.  The complaint was unsealed on August 30, 2011.  The

29


United States intervened in this action on July 8, 2011 and filed a separate complaint on September 9, 2011, alleging claims for violations of the Federal False Claims Act and common law fraud.  The states of Michigan and Indiana have also intervened as to claims arising under their respective state false claims acts, common law fraud, and unjust enrichment. On July 13, 2012, we filed an Answer and Affirmative Defense to Indiana's Amended Complaint. We intend to vigorously defend these lawsuits.  
We have also been named a defendant in a putative federal class action brought by the United Food and Commercial Workers Unions and Employers Midwest Health Benefits Fund (“UFCW”) under the Federal Racketeer Influenced and Corrupt Organizations Act alleging the same general conduct as set forth in the preceding paragraph.  We filed a motion to dismiss the complaint brought by UFCW on March 26, 2012, and the motion to dismiss was granted on July 16, 2012.  
Department of Justice Matter
On March 19, 2009, we were served with a subpoena by the Department of Justice requesting documents related to Strativa’s marketing of Megace® ES.  The subpoena indicated that the Department of Justice is currently investigating promotional practices in the sales and marketing of Megace® ES.  We have cooperated with the Department of Justice in this inquiry and will continue to do so.  Investigations of this type often result in settlements, including monetary amounts based on an agreed upon percentage of sales of the product at issue in the investigation.  We accrued $45,000 thousand in the first quarter of 2012 as management’s best estimate of potential loss related to a potential global settlement in this matter, pending the finalization of definitive settlement terms.
Declaratory Judgment
On October 14, 2011, we filed a declaratory complaint and a motion for preliminary injunction in the U.S. District Court for the District of Columbia seeking to preserve our First Amendment right to provide truthful information to physicians and other healthcare providers about the FDA-approved, on-label use of Megace® ES.
 
Other
We are, from time to time, a party to certain other litigations, including product liability litigations.  We believe that these litigations are part of the ordinary course of our business and that their ultimate resolution will not have a material effect on our financial condition, results of operations or liquidity. We intend to defend or, in cases where we are the plaintiff, to prosecute these litigations vigorously.

Note 17 – Discontinued Operations – Related Party Transaction:
In January 2006, we divested FineTech Laboratories, Ltd (“FineTech”), effective December 31, 2005.  We transferred the business for no proceeds to Dr. Arie Gutman, president and chief executive officer of FineTech.  Dr. Gutman also resigned from our Board of Directors.  In 2012 and 2011, we recorded tax amounts to discontinued operations for interest related to contingent tax liabilities.  In 2011, we recognized a tax benefit of approximately $20,000 thousand to discontinued operations due to a reversal of certain FineTech related contingent tax liabilities.  The results of FineTech operations are classified as discontinued for all periods presented because we have no continuing involvement in FineTech.

Note 18 - Segment Information:
We operate in two reportable business segments: generic pharmaceuticals (referred to as “Par Pharmaceutical” or “Par”) and branded pharmaceuticals (referred to as “Strativa Pharmaceuticals” or “Strativa”).  Branded products are marketed under brand names through marketing programs that are designed to generate physician and consumer loyalty.  Branded products generally are patent protected, which provides a period of market exclusivity during which they are sold with little or no direct competition.  Generic pharmaceutical products are the chemical and therapeutic equivalents of corresponding brand drugs.  The Drug Price Competition and Patent Term Restoration Act of 1984 provides that generic drugs may enter the market upon the approval of an ANDA and the expiration, invalidation or circumvention of any patents on corresponding brand drugs, or the expiration of any other market exclusivity periods related to the brand drugs. Our chief operating decision maker is our Chief Executive Officer.   
Our business segments were determined based on management’s reporting and decision-making requirements in accordance with FASB ASC 280-10 Segment Reporting.  We believe that our generic products represent a single operating segment because the demand for these products is mainly driven by consumers seeking a lower cost alternative to brand name drugs.  Par’s generic drugs are developed using similar methodologies, for the same purpose (e.g., seeking bioequivalence with a brand name drug nearing the end of its market exclusivity period for any reason discussed above).  Par’s generic products are produced using similar processes and standards mandated by the FDA, and Par’s generic products are sold to similar customers.  Based on the economic characteristics, production processes and customers of Par’s generic products, management has determined that Par’s generic pharmaceuticals are a single reportable business segment.  Our chief operating decision maker does not review the Par (generic) or Strativa (brand) segments in any more granularity, such as at the therapeutic or other classes or categories.  Certain of our expenses, such as the direct sales force and other sales and marketing expenses and

30


specific research and development expenses, are charged directly to either of the two segments.   Other expenses, such as general and administrative expenses and non-specific research and development expenses are allocated between the two segments based on assumptions determined by management.
 The financial data for the two business segments are as follows ($ amounts in thousands):

 
Three months ended
 
Six months ended
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Revenues:
 
 
 
 
 
 
 
Par Pharmaceutical
$
273,109

 
$
202,449

 
$
524,276

 
$
412,193

Strativa
21,224

 
21,739

 
41,529

 
44,947

Total revenues
$
294,333

 
$
224,188

 
$
565,805

 
$
457,140

Gross margin:
 
 
 
 
 
 
 
Par Pharmaceutical
$
127,121

 
$
83,994

 
$
209,571

 
$
176,554

Strativa
16,033

 
15,032

 
31,429

 
32,125

Total gross margin
$
143,154

 
$
99,026

 
$
241,000

 
$
208,679

Operating income (loss):
 
 
 
 
 
 
 
Par Pharmaceutical
$
81,408

 
$
51,845

 
$
105,456

 
$
(80,901
)
Strativa
1,363

 
(34,038
)
 
(43,898
)
 
(39,854
)
Total operating income (loss)
$
82,771

 
$
17,807

 
$
61,558

 
$
(120,755
)
Interest income
140

 
382

 
276

 
805

Interest expense
(3,069
)
 
(150
)
 
(6,163
)
 
(301
)
Provision (benefit) for income taxes
28,537

 
8,859

 
33,062

 
(20,587
)
Income (loss) from continuing operations
$
51,305

 
$
9,180

 
$
22,609

 
$
(99,664
)

Our chief operating decision maker does not review our assets, depreciation or amortization by business segment at this time as they are not material to Strativa.  Therefore, such allocations by segment are not provided.
Total revenues of our top selling products were as follows ($ amounts in thousands):


31


Product
Three months ended
 
Six months ended
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Par Pharmaceutical
 
 
 
 
 
 
 
Modafinil (Provigil®)
$
57,484

 
$

 
$
57,484

 
$

Metoprolol succinate ER (Toprol-XL®)
48,953

 
63,706

 
110,718

 
127,124

Budesonide (Entocort® EC)
33,513

 
16,357

 
71,497

 
16,357

Propafenone (Rythmol SR®)
17,888

 
13,311

 
36,980

 
35,350

Sumatriptan succinate injection (Imitrex®)
13,945

 
15,284

 
30,644

 
31,983

Bupropion ER (Wellbutrin®)
12,010

 

 
23,364

 

Chlorpheniramine/Hydrocodone (Tussionex®)
7,984

 
7,022

 
21,941

 
19,701

Zolpidem (Ambien CR®)
5,342

 

 
12,264

 

Cholestyramine Powder (Questran®)
4,958

 
4,077

 
9,878

 
7,760

Tramadol ER (Ultracet ER®)
4,593

 
5,873

 
10,422

 
11,954

Dronabinol (Marinol®)
4,444

 
8,118

 
12,047

 
14,989

Meclizine Hydrochloride (Antivert®)
3,783

 
4,562

 
7,969

 
9,437

Amlodipine and Benazepril HCl (Lotrel®)
1,729

 
12,505

 
4,177

 
30,675

Nateglinide (Starlix®)
3,518

 
3,815

 
7,542

 
8,120

Other (1)
46,170

 
38,774

 
95,160

 
81,809

Other product related revenues (2)
6,795

 
9,045

 
12,189

 
16,934

Total Par Pharmaceutical Revenues
$
273,109

 
$
202,449

 
$
524,276

 
$
412,193


Product
Three months ended
 
Six months ended
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Strativa
 
 
 
 
 
 
 
Megace® ES
$
14,212

 
$
14,050

 
$
26,390

 
$
28,135

Nascobal® Nasal Spray
5,380

 
6,274

 
11,312

 
10,152

Oravig®
(3
)
 
1,027

 
152

 
1,776

Zuplenz®
(106
)
 
263

 
(21
)
 
485

Other product related revenues (2)
1,741

 
125

 
3,696

 
4,399

Total Strativa Revenues
$
21,224

 
$
21,739

 
$
41,529

 
$
44,947


(1)
No single product in the other category is in excess of 3% of total generic revenues for the six-month period ended June 30, 2012 or for the six-month period ended June 30, 2011.
(2)
Other product related revenues represents licensing and royalty related revenues from profit sharing agreements related to products such as diazepam rectal gel, the generic version of Diastat®, and fenofibrate, the generic version of Tricor®.  Other product related revenues included in the Strativa segment relate primarily to Strativa’s share of the proceeds from Optimer Pharmaceuticals’ sale of certain rights in fidaxomicin to a third party.  
 
Note 19 - Subsequent Events:

On July 14, 2012, we entered into an Agreement and Plan of Merger (the “Agreement”) with Sky Growth Holdings Corporation, a Delaware corporation (“Parent”), and Sky Growth Acquisition Corporation, a Delaware corporation and a wholly owned subsidiary of Parent (“Merger Sub”). The Agreement provides for the merger of Merger Sub with and into the Company, with the Company surviving the Merger as a wholly-owned subsidiary of Parent (the “Merger”).
Parent and Merger Sub are beneficially owned by affiliates of TPG Capital, L.P. and were formed solely for the purposes of executing the Agreement and facilitating the Merger. The Agreement provides for a purchase price of approximately $1.9 billion for our fully diluted equity. We expect this transaction to close, subject to customary conditions, before the end of 2012. Some of the customary conditions to closing include obtaining the approval of the holders of a

32


majority of the outstanding shares of our common stock and the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
Under the Agreement, we may solicit superior proposals from third parties through August 24, 2012. Parent has certain termination rights that could require us to pay Parent a termination fee of $24 million or $48 million, based on the circumstances of the termination, plus in each case up to $7 million in Parent's expenses. We also have certain termination rights in certain circumstances.
On July 14, 2012, in conjunction with our execution of the Agreement, we modified our Rights Agreement dated as of October 27, 2004, with American Stock Transfer & Trust Company (the “Rights Agreement”), to render the Rights Agreement inapplicable to the Agreement and the Merger and to cause the Rights Agreement to terminate immediately prior to the effective time of the Merger.
For more information about the Merger, the Agreement and our modification of the Rights Agreement, please see our Current Report on Form 8-K, filed July 16, 2012 and our Preliminary Proxy Statement on Schedule 14A, expected to be filed on or about August 2, 2012.



33


ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

Forward-Looking Statements
Certain statements in this Quarterly Report constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including those concerning management’s expectations with respect to future financial performance, trends and future events, particularly relating to sales of current products and the development, approval and introduction of new products.  To the extent that any statements made in this Quarterly Report contain information that is not historical, such statements are essentially forward-looking.  These statements are often, but not always, made using words such as “estimates,” “plans,” “projects,” “anticipates,” “continuing,” “ongoing,” “expects,” “intends,” “believes,” “forecasts” or similar words and phrases.  Such forward-looking statements are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond our control, which could cause actual results and outcomes to differ materially from those expressed in this Quarterly Report.  Risk factors that might affect such forward-looking statements include those set forth in Item 1A (“Risk Factors”) of our Annual Report on Form 10-K for the year ended December 31, 2011, in Item 1A of Part II of this Quarterly Report on Form 10-Q, and from time to time in our other filings with the SEC, including Current Reports on Form 8-K, and on general industry and economic conditions.  Any forward-looking statements included in this Quarterly Report are made as of the date of this Quarterly Report only, and, subject to any applicable law to the contrary, we assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
The following discussion should be read in conjunction with our Condensed Consolidated Financial Statements and related Notes to Condensed Consolidated Financial Statements contained elsewhere in this Quarterly Report on Form 10-Q.

OVERVIEW
Par Pharmaceutical Companies, Inc. operates primarily in the United States as two business segments, our generic products division (“Par Pharmaceutical” or “Par”) for the development, manufacture and distribution of generic pharmaceuticals, and Strativa Pharmaceuticals (“Strativa Pharmaceuticals” or “Strativa”), our branded products division.   
The introduction of new products that generate adequate gross margins is critical to our ability to generate economic value and ultimately the creation of adequate returns for our stockholders.  Par Pharmaceutical, our generic products division, creates economic value by optimizing our current generic product portfolio and our pipeline of potential high-value first-to-file and first-to-market generic products.  Par Pharmaceutical is an attractive business partner because of its strong commercialization track record and presence in the generic trade.  
On July 14, 2012, we entered into an Agreement and Plan of Merger (the “Agreement”) with Sky Growth Holdings Corporation, a Delaware corporation (“Parent”), and Sky Growth Acquisition Corporation, a Delaware corporation and a wholly owned subsidiary of Parent (“Merger Sub”). The Agreement provides for the merger of Merger Sub with and into the Company, with the Company surviving the Merger as a wholly-owned subsidiary of Parent (the “Merger”). Parent and Merger Sub are beneficially owned by affiliates of TPG Capital, L.P. and were formed solely for the purposes of executing the Agreement and facilitating the Merger. The Agreement provides for a purchase price of approximately $1.9 billion for our fully diluted equity. We expect this transaction to close, subject to customary conditions, before the end of 2012. Some of the customary conditions to closing include obtaining the approval of the holders of a majority of the outstanding shares of our common stock and the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under the Agreement, we may solicit superior proposals from third parties through August 24, 2012. Parent has certain termination rights that could require us to pay Parent a termination fee of $24 million or $48 million, based on the circumstances of the termination, plus in each case up to $7 million in Parent's expenses. We also have certain termination rights in certain circumstances. For more information about the Merger, and the Agreement, please see our Current Report on Form 8-K, filed July 16, 2012.
On November 17, 2011, we completed our acquisition of Anchen Incorporated and its subsidiary Anchen Pharmaceuticals, Inc. (collectively referred to as “Anchen”), a privately held generic pharmaceutical company.  Anchen’s assets include five currently marketed generic products, numerous in-process research and development products, a workforce of approximately 200 employees and leased facilities with manufacturing capabilities and research and development capabilities.  On February 17, 2012, we completed our acquisition of Edict Pharmaceuticals Private Limited (“Edict”), a Chennai, India-based developer and manufacturer of generic pharmaceuticals, which has been renamed Par Formulations Private Limited.  Par Formulations’ assets include numerous in-process research and development products, a workforce of approximately 100 employees and a facility with manufacturing capabilities and research and development capabilities.    
In addition to these acquisitions, Par’s recent achievements included the product launches of generic versions of Provigil®, and Actiq®. Par also continues to execute business development agreements, settle Paragraph IV litigations, and all three of Par's manufacturing facilities passed all recent FDA inspections.  As a result, we believe we are well positioned to compete in the generic marketplace over the long term.  We target high-value, first-to-file Paragraph IVs or first–to-market

34


product opportunities.  We had 72 total filed ANDAs that represented over $20 billion of combined branded product sales.  These ANDA filings included 23 first-to-files product opportunities.  Generally, products that we have developed internally contribute higher gross margin percentages than products that we sell under supply and distribution agreements, because under such agreements, we typically pay a percentage of the gross or net profits (or a percentage of sales) to our strategic partners.  
Strativa acquired the worldwide rights to Nascobal® Nasal Spray in 2009.  Nascobal® Nasal Spray is an FDA-approved prescription vitamin B12 treatment indicated for maintenance of remission in certain pernicious anemia patients, as well as a supplement for a variety of B12 deficiencies.  It is the first and currently only once-weekly, self-administered alternative to B12 injections.  In June 2011, we announced our plans to resize Strativa as part of a strategic assessment.  We reduced our Strativa workforce by approximately 90 people.  The remaining Strativa sales force focus their marketing efforts on Megace® ES and Nascobal® Nasal Spray.  In July 2011, we received a notice letter from a generic pharmaceutical manufacturer advising that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. FDA containing a Paragraph IV certification referencing Megace® ES.  Megace® ES is protected by Alkermes Pharma Ireland Limited (Elan)’s U.S. Patents 6,592,903 and 7,101,576.  We intend, with Elan, to investigate the Paragraph IV certification and ANDA, and to enforce Elan’s patents, which expire in 2020 and 2024, respectively, as appropriate.  Together with Megace® ES and the current level of personnel deployed in the field, we believe Strativa will generate cash inflows in excess of cash outflows into the foreseeable future.      
Sales and gross margins of our products depend principally on (i) our ability to introduce new generic and brand products and the introduction of other generic and brand products in direct competition with our products; (ii) the ability of generic competitors to quickly enter the market after our relevant patent or exclusivity periods expire, or during our exclusivity periods with authorized generic products, diminishing the amount and duration of significant profits we generate from any one product; (iii) the pricing practices of competitors and the removal of competing products from the market; (iv) the continuation of our existing license, supply and distribution agreements and our ability to enter into new agreements; (v) the consolidation among distribution outlets through mergers, acquisitions and the formation of buying groups; (vi) the willingness of generic drug customers, including wholesale and retail customers, to switch among drugs of different generic pharmaceutical manufacturers; (vii) our ability to procure approval of ANDAs and NDAs and the timing and success of our future new product launches; (viii) our ability to obtain marketing exclusivity periods for our generic products; (ix) our ability to maintain patent protection of our brand products; (x) the extent of market penetration for our existing product line; (xi) customer satisfaction with the level, quality and amount of our customer service; and (xii) the market acceptance of our recently introduced branded product (Nascobal® Nasal Spray) and the successful development and commercialization of any future in-licensed branded product pipeline.
Net sales and gross margins derived from generic pharmaceutical products often follow a pattern based on regulatory and competitive factors that we believe to be unique to the generic pharmaceutical industry.  As the patent(s) for a brand name product and the related exclusivity period(s) expire, the first generic manufacturer to receive regulatory approval from the FDA for a generic equivalent of the product is often able to capture a substantial share of the market.  At that time, however, the branded company may license the right to distribute an “authorized generic” product to a competing generic company.  As additional generic manufacturers receive regulatory approvals for competing products, the market share and the price of those products have typically declined - often significantly - depending on several factors, including the number of competitors, the price of the brand product and the pricing strategy of the new competitors.
Net sales and gross margins derived from brand pharmaceutical products typically follow a different pattern.  Sellers of brand pharmaceutical products benefit from years of being the exclusive supplier to the market due to patent protections for the brand products.  The benefits include significantly higher gross margins relative to sellers of generic pharmaceutical products.  However, commercializing brand pharmaceutical products is more costly than generic pharmaceutical products. Sellers of brand pharmaceutical products often have increased infrastructure costs relative to sellers of generic pharmaceutical products and make significant investments in the development and/or licensing of these products without a guarantee that these expenditures will result in the successful development or launch of brand products that will prove to be commercially successful.  Selling brand products also tends to require greater sales and marketing expenses to create a market for the products than is necessary with respect to the sale of generic products.  Just as we compete against companies selling branded products when we sell generic products, we confront the same competitive pressures when we sell our branded products.  Specifically, after patent protections expire, generic products can be sold in the market at a significantly lower price than the branded version, and, where available, may be required or encouraged in preference to the branded version under third party reimbursement programs, or substituted by pharmacies for branded versions by law.

Healthcare Reform Impacts
For 2012, the impact of healthcare reform is expected to have a similar impact on our net revenue as it did in 2011. The gross margin and net income impact of these provisions is highly dependent upon product sales mix between products that are partnered with third parties and non-partnered products.

35


Par Pharmaceutical - Generic Products Division
Our strategy for our generic products division is to continue to differentiate ourselves by carefully choosing opportunities with minimal competition (e.g., first-to-file and first-to-market products).  By leveraging our expertise in research and development, manufacturing and distribution, and business development, we are able to effectively and efficiently pursue these opportunities and support our partners.
In the six month period ended June 30, 2012, our generic business net revenues and gross margin were concentrated in a few products.  The top eight generic products (metoprolol, budesonide, modafinil, propafenone, sumatriptan, bupropion ER, chlorpheniramine/hydrocodone, and zolpidem) accounted for approximately 64% of total consolidated revenues and approximately 58% of total consolidated gross margins in the quarter ended June 30, 2012.  
We began selling metoprolol in 2006 as the authorized generic distributor pursuant to a supply and distribution agreement with AstraZeneca.  We had three competitors in the metoprolol market during the six months ended June 30, 2012 as compared to two competitors in the prior year period.  Additional competitors on any or all of the four SKUs could result in significant additional declines in sales volume and unit price, which would negatively impact our revenues and gross margins.  As the authorized generic distributor for metoprolol, we do not control the manufacturing of the product, and any disruption in supply due to manufacturing or transportation issues could also have a negative effect on our revenues and gross margins.
In 2008, we launched generic versions of Imitrex® (sumatriptan) injection 4mg and 6mg starter kits and 4mg and 6mg prefilled syringe cartridges pursuant to a supply and distribution agreement with GlaxoSmithKline plc.  On August 1, 2011, an additional competitor launched a single strength of sumatriptan.  Our supply agreement with GlaxoSmithKline expired in November 2011, and we have not secured a new supply of this product.  We are continuing to distribute our existing inventory until depleted.  As of June 30, 2012, we believe we were the sole generic distributor of two SKUs with two competitors on the 6mg strength.  Our future sales volume and unit price for our remaining inventory may be adversely impacted by any additional competition.   
In 2010, our licensing partner, Tris Pharma, Inc., received final FDA approval for its ANDA for hydrocodone polistirex and chlorpheniramine polistirex (CIII) extended-release (ER) oral suspension (equivalent to 10 mg of hydrocodone bitartrate and 8 mg of chlorpheniramine maleate per 5 mL), a generic version of UCB Manufacturing, Inc.’s Tussionex®.  We participate in a profit sharing arrangement with Tris based on our commercial sale of generic Tussionex®.  We commenced a limited launch of generic Tussionex® on October 5, 2010.  Our market share will continue to be limited for the foreseeable future by Drug Enforcement Administration regulations concerning allowable commercial quantities of controlled substances like hydrocodone, which is contained in generic Tussionex®.  We do not control the manufacturing of the product, and any disruption in supply due to manufacturing or transportation issues could also have a negative effect on our revenues and gross margins.       
We began selling propafenone, the generic version of Rythmol® SR, in January 2011.  We were awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for this product.  We manufacture and distribute this product.  We believe we remained the single source generic supplier for this product as of June 30, 2012.  The market entry of any competition on this product will result in declines in sales volume and unit price, which would negatively impact our revenues and gross margins.  
We began selling budesonide, the generic version of Entocort® EC, in June 2011 as the authorized generic distributor pursuant to a supply and distribution agreement with AstraZeneca.  We are one of two competitors in this market.  As the authorized generic distributor for budesonide, we do not control the manufacturing of the product, and any disruption in supply due to manufacturing or transportation issues could also have a negative effect on our revenues and gross margins.
On November 17, 2011, we completed our acquisition of Anchen.  The Anchen assets we acquired include five currently marketed generic products, including bupropion ER (generic version of Wellbutrin XL®) and zolpidem ER (generic version of Ambien CR®).  We have multiple competitors in these markets.  The remaining net book value of the related intangible asset related to these Anchen developed products will be amortized over a weighted average amortization period of approximately nine years.
In October 2011, we acquired the rights to three products from Teva Pharmaceuticals in connection with Teva's acquisition of Cephalon. As part of this acquisition, we obtained the U.S. rights to market modafinil tablets, the generic version of Provigil®. Par began shipping to the trade all strengths of modafinil tablets in April 2012. Modafinil tablets were not previously marketed by Teva.   We allocated $6 million of the purchase price of the acquisition to modafinil tablets based on expected future cash flows.  Amortization expense of the intangible asset related to modafinil tablets commenced when the product was launched in April 2012. We do not control the manufacturing of the product, and any disruption in supply due to manufacturing or transportation issues could also have a negative effect on our revenues and gross margins.
In addition, our investments in generic product development, including projects with development partners, are expected to yield new ANDA filings.  These ANDA filings are expected to lead to product launches based on one or more of the following: expiry of the relevant 30-month stay period; patent expiry date; and expiry of regulatory exclusivity.  However, such potential product launches may be delayed or may not occur due to various circumstances, including extended litigation,

36


outstanding citizens petitions, other regulatory requirements set forth by the FDA, and stays of litigation.  These ANDA filings would be significant mileposts for us, as we expect many of these potential products to be first-to-file/first-to-market opportunities with gross margins in excess of the average of our current portfolio.  We or our strategic partners had approximately 72 ANDAs pending with the FDA, which include 23 first-to-file opportunities.  No assurances can be given that we or any of our strategic partners will successfully complete the development of any of these potential products either under development or proposed for development, that regulatory approvals will be granted for any such product, that any approved product will be produced in commercial quantities or sold profitably.  

Strativa Pharmaceuticals - Branded Products Division
For Strativa, in the near term we will continue to invest in the marketing and sales of our existing products (Megace® ES and Nascobal® Nasal Spray).  In addition, in the longer term, we will continue to consider new strategic licenses and acquisitions to expand Strativa’s presence in supportive care and adjacent commercial areas.   
In July 2005, we received FDA approval for our first NDA and began marketing Megace® ES (megestrol acetate) oral suspension.  Megace® ES is indicated for the treatment of anorexia, cachexia or any unexplained significant weight loss in patients with a diagnosis of AIDS and utilizes the Megace® brand name that we have licensed from Bristol-Myers Squibb Company.  We promoted Megace® ES as our primary brand product from 2005 through March 2009.  With the acquisition of Nascobal® in March 2009, Strativa increased its sales force and turned its focus on marketing both products.  In July 2011, we received a notice letter from a generic pharmaceutical manufacturer, TWi Pharmaceuticals, Inc., advising that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. FDA containing a Paragraph IV certification referencing Megace® ES. Megace® ES is protected by Alkermes Pharma Ireland Limited (Elan)’s U.S. Patents 6,592,903 and 7,101,576.  We, along with EDT Pharma Holdings Ltd. (now known as Alkermes Pharma Ireland Limited) (Elan), filed a complaint against TWi in the U.S. District Court for the District of Maryland and another complaint in the U.S. District Court for the Northern District of Illinois, in September 2011, alleging infringement of Elan’s patents, which expire in 2020 and 2024, respectively.  
On March 31, 2009, we acquired the worldwide rights to Nascobal® (cyanocobalamin, USP) Nasal Spray from QOL Medical, LLC.  Under the terms of the all cash transaction, we paid QOL Medical $54.5 million for the worldwide rights to Nascobal®.  We manufacture Nascobal® with assets acquired on March 31, 2009 from MDRNA, Inc.  The remaining net book value of the related intangible asset was $39.9 million at June 30, 2012, and will be amortized over approximately nine years.  

OTHER CONSIDERATIONS
In addition to the substantial costs of product development, we may incur significant legal costs in bringing certain products to market.  Litigation concerning patents and proprietary rights is often protracted and expensive.  Pharmaceutical companies with patented brand products increasingly are suing companies that produce generic forms of their products for alleged patent infringement or other violations of intellectual property rights, which could delay or prevent the entry of such generic products into the market.  Generally, a generic drug may not be marketed until the applicable patent(s) on the brand drug expires.  When an ANDA is filed with the FDA for approval of a generic drug, the filer may certify either that any patent listed by the FDA as covering the brand product is about to expire, in which case the ANDA will not become effective until the expiration of such patent, or that the patent listed as covering the brand drug is invalid or will not be infringed by the manufacture, sale or use of the new drug for which the ANDA is filed.  In either case, there is a substantial risk that a brand pharmaceutical company may sue the filer for alleged patent infringement or other violations of intellectual property rights.  Because a substantial portion of our current business involves the marketing and development of generic versions of brand products, the threat of litigation, the outcome of which is inherently uncertain, is always present.  Such litigation is often costly and time-consuming, and could result in a substantial delay in, or prevent, the introduction and/or marketing of products, which could have a material adverse effect on our business, financial condition, prospects and results of operations.  

RESULTS OF OPERATIONS
Results of operations, including segment net revenues, segment gross margin and segment operating loss information for our Par Generic Products segment and our Strativa Branded Products segment, consisted of the following:

Revenues
Total revenues of our top selling products were as follows:


 

37


 
Three months ended
 
Six months ended
($ amounts in thousands)
June 30,
2012
 
June 30,
2011
 
$ Change
 
June 30,
2012
 
June 30,
2011
 
$ Change
Product
 
 
 
 
 
 
 
 
 
 
 
     Par Pharmaceutical
 
 
 
 
 
 
 
 
 
 
 
Modafinil (Provigil®)
$
57,484

 
$

 
$
57,484

 
$
57,484

 
$

 
$
57,484

Metoprolol succinate ER (Toprol-XL®)
48,953

 
63,706

 
(14,753
)
 
110,718

 
127,124

 
(16,406
)
Budesonide (Entocort® EC)
33,513

 
16,357

 
17,156

 
71,497

 
16,357

 
55,140

Propafenone (Rythmol SR®)
17,888

 
13,311

 
4,577

 
36,980

 
35,350

 
1,630

Sumatriptan succinate injection (Imitrex®)
13,945

 
15,284

 
(1,339
)
 
30,644

 
31,983

 
(1,339
)
Bupropion ER (Wellbutrin®)
12,010

 

 
12,010

 
23,364

 

 
23,364

Chlorpheniramine/Hydrocodone (Tussionex®)
7,984

 
7,022

 
962

 
21,941

 
19,701

 
2,240

Zolpidem (Ambien CR®)
5,342

 

 
5,342

 
12,264

 

 
12,264

Cholestyramine Powder (Questran®)
4,958

 
4,077

 
881

 
9,878

 
7,760

 
2,118

Tramadol ER (Ultracet ER®)
4,593

 
5,873

 
(1,280
)
 
10,422

 
11,954

 
(1,532
)
Dronabinol (Marinol®)
4,444

 
8,118

 
(3,674
)
 
12,047

 
14,989

 
(2,942
)
Meclizine Hydrochloride (Antivert®)
3,783

 
4,562

 
(779
)
 
7,969

 
9,437

 
(1,468
)
Amlodipine and Benazepril HCl (Lotrel®)
1,729

 
12,505

 
(10,776
)
 
4,177

 
30,675

 
(26,498
)
Nateglinide (Starlix®)
3,518

 
3,815

 
(297
)
 
7,542

 
8,120

 
(578
)
Other
46,170

 
38,774

 
7,396

 
95,160

 
81,809

 
13,351

Other product related revenues
6,795

 
9,045

 
(2,250
)
 
12,189

 
16,934

 
(4,745
)
Total Par Pharmaceutical Revenues
$
273,109

 
$
202,449

 
$
70,660

 
$
524,276

 
$
412,193

 
$
112,083

 
 
 
 
 
 
 
 
 
 
 
 
     Strativa
 
 
 
 
 
 
 
 
 
 
 
Megace® ES
$
14,212

 
$
14,050

 
$
162

 
$
26,390

 
$
28,135

 
$
(1,745
)
Nascobal® Nasal Spray
5,380

 
6,274

 
(894
)
 
11,312

 
10,152

 
1,160

Oravig®
(3
)
 
1,027

 
(1,030
)
 
152

 
1,776

 
(1,624
)
Zuplenz®
(106
)
 
263

 
(369
)
 
(21
)
 
485

 
(506
)
Other product related revenues
1,741

 
125

 
1,616

 
3,696

 
4,399

 
(703
)
Total Strativa Revenues
$
21,224

 
$
21,739

 
$
(515
)
 
$
41,529

 
$
44,947

 
$
(3,418
)

 
 
Three months ended
 
 
 
 
 
 
 
 
 
 
Percentage of Total Revenues
($ in thousands)
 
June 30,
2012
 
June 30,
2011
 
$ Change
 
% Change
 
June 30,
2012
 
June 30,
2011
Revenues:
 
 
 
 
 
 
 
 
 
 
 
 
Par Pharmaceutical
 
$
273,109

 
$
202,449

 
$
70,660

 
34.9
 %
 
92.8
%
 
90.3
%
Strativa
 
21,224

 
21,739

 
(515
)
 
(2.4
%)
 
7.2
%
 
9.7
%
Total revenues
 
$
294,333

 
$
224,188

 
$
70,145

 
31.3
 %
 
100.0
%
 
100.0
%
             

38


 
 
Six months ended
 
 
 
 
 
 
 
 
 
 
Percentage of Total Revenues
($ in thousands)
 
June 30,
2012
 
June 30,
2011
 
$ Change
 
% Change
 
June 30,
2012
 
June 30,
2011
Revenues:
 
 
 
 
 
 
 
 
 
 
 
 
Par Pharmaceutical
 
$
524,276

 
$
412,193

 
$
112,083

 
27.2
 %
 
92.7
%
 
90.2
%
Strativa
 
41,529

 
44,947

 
(3,418
)
 
(7.6
)%
 
7.3
%
 
9.8
%
Total revenues
 
$
565,805

 
$
457,140

 
$
108,665

 
23.8
 %
 
100.0
%
 
100.0
%

The increase in generic segment revenues in the second quarter and year-to-date period of 2012 was primarily due to the launches of modafinil in April 2012, budesonide in June 2011, olanzapine in October 2011 (included in “Other” above), and fentanyl citrate (included in “Other” above) in October 2011, coupled with revenues from the products acquired in the Anchen Acquisition on November 17, 2011, primarily bupropion ER and zolpidem.        
The increases above in the second quarter and year-to-date period of 2012 were tempered by:
On-going competition on all SKUs (packaging sizes) of metoprolol succinate ER.  The dollar amount decrease of metoprolol revenues for the second quarter 2012 can be attributed to a decrease in the price (approximately $11.9 million) coupled with a decrease in volume of units sold (approximately $2.9 million).  The dollar amount decrease of metoprolol revenues for the year-to-date period of 2012 can be attributed to a decrease in the price (approximately $24.3 million) offset by an increase in volume of units sold (approximately $7.9 million). We expect metoprolol revenues to continue to decline in the future as competition increases in this market.  
The non-recurrence of prior year launch volumes of amlodipine and benzepril HCl, coupled with significant competition at the end of the exclusivity period.

Net sales of contract-manufactured products (which are manufactured for us by third-parties under contract) and licensed products (which are licensed to us from third-party development partners and also are generally manufactured by third parties) were approximately 61% of our total product revenues for the six month period ended June 30, 2012 and approximately 55% of our total product revenues for the six month period ended June 30, 2011.  The increase in the percentage is primarily driven by increased revenues of modafinil and budesonide combined with the declines of internally manufactured products launched in first quarter 2011, primarily amlodipine and benazepril HCl.  We are substantially dependent upon contract-manufactured and licensed products for our overall sales, and any inability by our suppliers to meet demand could adversely affect our future sales.  
The decrease in the Strativa segment revenues in the second quarter of 2012 was primarily due to the decrease in Oravig® and Nascobal® revenues tempered by other product-related revenues driven by higher royalties earned of  $1.7 million as compared to the prior year from Strativa’s share of the proceeds from Optimer Pharmaceuticals’ sale of certain rights in fidaxomicin to a third party.      
The decrease in the Strativa segment revenues in the year-to-date period of 2012 was primarily due to a net sales decline of Megace® ES primarily due to decreased volume coupled with a decrease in average net selling price as compared to the prior year comparable periods coupled with a decrease in Oravig® revenues. The decreases were tempered by the increased prescription volume of Nascobal® in the year-to-date period of 2012.  
 
Gross Revenues to Total Revenues Deductions
Generic drug pricing at the wholesale level can create significant differences between our invoice price and net selling price.  Wholesale customers purchase product from us at invoice price, then resell the product to specific healthcare providers on the basis of prices negotiated between us and the providers, and the wholesaler submits a chargeback credit to us for the difference.  We record estimates for these chargebacks as well as sales returns, rebates and incentive programs, and the sales allowances for all our customers at the time of sale as deductions from gross revenues, with corresponding adjustments to our accounts receivable reserves and allowances.
We have the experience and the access to relevant information that we believe necessary to reasonably estimate the amounts of such deductions from gross revenues.  Some of the assumptions we use for certain of our estimates are based on information received from third parties, such as wholesale customer inventory data and market data, or other market factors beyond our control.  The estimates that are most critical to the establishment of these reserves, and therefore would have the largest impact if these estimates were not accurate, are estimates related to expected contract sales volumes, average contract pricing, customer inventories and return levels.  We regularly review the information related to these estimates and adjust our reserves accordingly if and when actual experience differs from previous estimates.  With the exception of the product returns allowance, the ending balances of account receivable reserves and allowances generally are eliminated during a two-month to four-month period, on average.

39


We recognize revenue for product sales when title and risk of loss have transferred to our customers and when collectability is reasonably assured.  This is generally at the time that products are received by the customers.  Upon recognizing revenue from a sale, we record estimates for chargebacks, rebates and incentives, returns, cash discounts and other sales reserves that reduce accounts receivable.  Our gross revenues for the six month periods ended June 30, 2012 and 2011 before deductions for chargebacks, rebates and incentive programs (including rebates paid under federal and state government Medicaid drug reimbursement programs), sales returns and other sales allowances were as follows:
 
 
 
Six months ended
($ thousands)
 
June 30,
2012
 
Percentage of Gross Revenues
 
June 30,
2011
 
Percentage of Gross Revenues
Gross revenues
 
$
967,538

 
 
 
$
721,841

 
 
 
 
 
 
 
 
 
 
 
Chargebacks
 
(205,290
)
 
21.2
 %
 
(120,659
)
 
16.7
 %
Rebates and incentive programs
 
(96,940
)
 
10.0
 %
 
(51,408
)
 
7.1
 %
Returns
 
(13,760
)
 
1.4
 %
 
(15,543
)
 
2.2
 %
Cash discounts and other
 
(58,834
)
 
6.1
 %
 
(49,962
)
 
6.9
 %
Medicaid rebates and rebates due
   under other US Government
   pricing programs
 
(26,909
)
 
2.8
 %
 
(27,129
)
 
3.8
 %
Total deductions
 
(401,733
)
 
41.5
 %
 
(264,701
)
 
36.7
 %
 
 
 
 
 
 
 
 
 
Total revenues
 
$
565,805

 
(58.5
)%
 
$
457,140

 
(63.3
)%

The total gross-to-net adjustments as a percentage of sales increased for the six months ended June 30, 2012 compared to the six months ended June 30, 2011 primarily due to an increase in chargebacks and rebates and incentive programs.
Chargebacks: the increase was primarily driven by the impact of higher chargeback rates for Anchen products coupled with increasing rates for products launched in 2011 (e.g., amlodipine and benzepril HCl), tempered by the launch of modafinil, which has a lower than average rate.
Rebates and incentive programs: the increase was primarily driven by product mix, mainly metoprolol and modafinil, partially offset by the impact of new product launches in 2011.
Returns:  the decrease was driven by lower metoprolol and sumatriptan returns coupled with increased sales volume of products with lower than average return rates and the recovery in 2012 related to a customer dispute regarding invalid deductions taken in prior years. 
Cash discounts and other: the decrease in rate was primarily due to non-recurrence of 2011 price adjustments for amlodipine and benzepril HCl.
Medicaid rebates and rebates due under other U.S. Government pricing programs: decrease was primarily due to lower estimated expense for the “donut hole” (a 50% discount on cost for certain Medicare Part D beneficiaries for certain drugs purchased during the Part D Medicare coverage gap) in the year-to-date period of 2012 as compared to the prior year period. 
The following tables summarize the activity for the six months ended June 30, 2012 and June 30, 2011 in the accounts affected by the estimated provisions described above ($ amounts in thousands):


40


 
Six months ended June 30, 2012
Accounts receivable reserves
Beginning balance
 
Provision recorded for current period sales
 
(Provision) reversal recorded for prior period sales
 
Credits processed
 
Ending balance
Chargebacks
$
(20,688
)
 
$
(205,290
)
 
$

(1)
$
197,280

 
$
(28,698
)
Rebates and incentive programs
(35,132
)
 
(96,881
)
 
(59
)
 
87,248

 
(44,824
)
Returns
(58,672
)
 
(15,362
)
 
1,602

(3)
12,026

 
(60,406
)
Cash discounts and other
(28,672
)
 
(58,025
)
 
(809
)
 
66,401

 
(21,105
)
Total
$
(143,164
)
 
$
(375,558
)
 
$
734

 
$
362,955

 
$
(155,033
)
 
 
 
 
 
 
 
 
 
 
Accrued liabilities (2)
$
(39,614
)
 
$
(26,909
)
 
$

 
$
38,055

 
$
(28,468
)

 
Six months ended June 30, 2011
Accounts receivable reserves  
Beginning balance
 
Provision recorded for current period sales
 
(Provision) reversal recorded for prior period sales
 
Credits processed
 
Ending balance
Chargebacks
$
(19,482
)
 
$
(120,659
)
 
$

(1)
$
121,055

 
$
(19,086
)
Rebates and incentive programs
(23,273
)

(52,068
)
 
660

 
51,402

 
(23,279
)
Returns
(48,928
)

(15,808
)

265

 
10,420

 
(54,051
)
Cash discounts and other
(16,606
)

(49,605
)

(357
)
 
48,414

 
(18,154
)
Total
$
(108,289
)
 
$
(238,140
)
 
$
568

 
$
231,291

 
$
(114,570
)
 
 
 
 
 
 
 
 
 
 
Accrued liabilities (2)
$
(32,169
)
 
$
(27,473
)
 
$
344

 
$
27,150

 
$
(32,148
)


(1)
Unless specific in nature, the amount of provision or reversal of reserves related to prior periods for chargebacks is not determinable on a product or customer specific basis; however, based upon historical analysis and analysis of activity in subsequent periods, we have determined that our chargeback estimates remain reasonable.
(2)
Includes amounts due to indirect customers for which no underlying accounts receivable exists and is principally comprised of Medicaid rebates and rebates due under other U.S. Government pricing programs, such as TriCare, and the Department of Veterans Affairs.  
(3)
The amount principally represents the resolution of a customer dispute in the first quarter of 2012 regarding invalid deductions taken in prior years of approximately $1,700 thousand.  
Use of Estimates in Reserves
We believe that our reserves, allowances and accruals for items that are deducted from gross revenues are reasonable and appropriate based on current facts and circumstances.  It is possible however, that other parties applying reasonable judgment to the same facts and circumstances could develop different allowance and accrual amounts for items that are deducted from gross revenues. Additionally, changes in actual experience or changes in other qualitative factors could cause our allowances and accruals to fluctuate, particularly with newly launched or acquired products.  We review the rates and amounts in our allowance and accrual estimates on a quarterly basis.  If future estimated rates and amounts are significantly greater than those reflected in our recorded reserves, the resulting adjustments to those reserves would decrease our reported net revenues; conversely, if actual product returns, rebates and chargebacks are significantly less than those reflected in our recorded reserves, the resulting adjustments to those reserves would increase our reported net revenues.  If we were to change our assumptions and estimates, our reserves would change, which would impact the net revenues that we report.  We regularly review the information related to these estimates and adjust our reserves accordingly, if and when actual experience differs from previous estimates.  

Gross Margin

41


 
 
Three months ended
 
 
 
 
 
 
 
 
Percentage of Total Revenues
($ in thousands)
 
June 30,
2012
 
June 30,
2011
 
$ Change
 
June 30,
2012
 
June 30,
2011
Gross margin:
 
 
 
 
 
 
 
 
 
 
   Par Pharmaceutical
 
$
127,121

 
$
83,994

 
$
43,127

 
46.5
%
 
41.5
%
   Strativa
 
16,033

 
15,032

 
1,001

 
75.5
%
 
69.1
%
Total gross margin
 
$
143,154

 
$
99,026

 
$
44,128

 
48.6
%
 
44.2
%

The increase in Par Pharmaceutical gross margin dollars for the three months ended June 30, 2012 is primarily due to the launch of modafinil in April 2012 coupled with launches of budesonide in June 2011, olanzapine in October 2011, and fentanyl citrate in October 2011, coupled with a full three months of operating results from the products acquired in the Anchen Acquisition, primarily bupropion ER and zolpidem. These increases were tempered by pre-launch inventory write-offs during the second quarter of 2012 and competition for amlodipine and benzepril HCl in beginning in the latter half of 2011.
Strativa gross margin dollars increased for the three months ended June 30, 2012, primarily due to the increase in other product-related revenues driven by Strativa’s share of the proceeds from Optimer Pharmaceuticals’ sale of certain rights in fidaxomicin in Europe to a third party tempered by lower gross margin associated with Nascobal® due to lower volume and lower pricing due to customer mix.           

 
 
Six months ended
 
 
 
 
 
 
 
 
Percentage of Total Revenues
($ in thousands)
 
June 30,
2012
 
June 30,
2011
 
$ Change
 
June 30,
2012
 
June 30,
2011
Gross margin:
 
 
 
 
 
 
 
 
 
 
   Par Pharmaceutical
 
$
209,571

 
$
176,554

 
$
33,017

 
40.0
%
 
42.8
%
   Strativa
 
31,429

 
32,125

 
(696
)
 
75.7
%
 
71.5
%
Total gross margin
 
$
241,000

 
$
208,679

 
$
32,321

 
42.6
%
 
45.6
%

The increase in Par Pharmaceutical gross margin dollars for the six months ended June 30, 2012 is primarily due to the launch of modafinil in April 2012 coupled with launches of budesonide in June 2011, olanzapine in October 2011, and fentanyl citrate in October 2011, coupled with the operating results from the products acquired in the Anchen Acquisition, primarily bupropion ER and zolpidem. These increases were tempered by pre-launch inventory write-offs during the year-to-date period of 2012 coupled with lower gross margin from amlodipine and benzepril HCl revenues (approximately $23 million) and increased amortization of intangible assets associated with the Anchen Acquisition (approximately $17 million).
Strativa gross margin dollars decreased for the year-to-date period ended June 30, 2012, primarily due to a net sales decline of Megace® ES primarily due to decreased volume coupled with a decrease in other product-related revenues driven by the non-recurrence of a $4.3 million royalty earned in the prior year from Strativa’s share of the proceeds from Optimer Pharmaceuticals’ sale of certain rights in fidaxomicin in Europe to a third party. The decreases were tempered by the increased prescription volume of Nascobal® in the year-to-date period of 2012.

Operating Expenses

Research and Development

 
 
Three months ended
 
 
 
 
 
 
 
 
 
 
Percentage of Total Revenues
($ in thousands)
 
June 30,
2012
 
June 30,
2011
 
$ Change
 
% Change
 
June 30,
2012
 
June 30,
2011
Research and development:
 
 
 
 
 
 
 
 
 
 
 
 
   Par Pharmaceutical
 
$
20,032

 
$
7,634

 
$
12,398

 
162.4
%
 
7.3
%
 
3.8
%
   Strativa
 
684

 
443

 
241

 
54.4
%
 
3.2
%
 
2.0
%
Total research and development
 
$
20,716

 
$
8,077

 
$
12,639

 
156.5
%
 
7.0
%
 
3.6
%

42



Par Pharmaceutical:
The increase in Par Pharmaceutical research and development expense for the three month period ended June 30, 2012 is driven by:
$3.9 million of incremental employment related costs resulting from our November 17, 2011 acquisition of Anchen Pharmaceuticals, Inc. and our February 17, 2012 acquisition of Edict Pharmaceuticals;
a $3.8 million increase in biostudy, clinical trial and material costs related to ongoing internal development of generic products; and,
a net $1.9 million increase in outside development costs driven by milestone payments under existing product development agreements.
Strativa:
Strativa research and development principally reflects FDA filing fees for the three months ended June 30, 2012 and June 30, 2011.

 
 
Six months ended
 
 
 
 
 
 
 
 
 
 
Percentage of Total Revenues
($ in thousands)
 
June 30,
2012
 
June 30,
2011
 
$ Change
 
% Change
 
June 30,
2012
 
June 30,
2011
Research and development:
 
 
 
 
 
 
 
 
 
 
 
 
   Par Pharmaceutical
 
$
49,683

 
$
17,711

 
$
31,972

 
180.5
 %
 
9.5
%
 
4.3
%
   Strativa
 
933

 
1,076

 
(143
)
 
(13.3
)%
 
2.2
%
 
2.4
%
Total research and development
 
$
50,616

 
$
18,787

 
$
31,829

 
169.4
 %
 
8.9
%
 
4.1
%

Par Pharmaceutical:
The increase in Par Pharmaceutical research and development expense for the six month period ended June 30, 2012 is driven by:
a net $13.8 million increase in outside development costs driven by an upfront payment for an exclusive acquisition and license agreement coupled with milestone payments under existing product development agreements;
$7.9 million of incremental employment related costs resulting from our November 17, 2011 acquisition of Anchen Pharmaceuticals, Inc. and our February 17, 2012 acquisition of Edict Pharmaceuticals;
a $5.5 million increase in biostudy, clinical trial and material costs related to ongoing internal development of generic products; and,
$1.1 million of incremental drug registry fees.
Strativa:
Strativa research and development principally reflects FDA filing fees for the six months ended June 30, 2012 and June 30, 2011.

 
Selling, General and Administrative Expenses

 
 
Three months ended
 
 
 
 
 
 
 
 
 
 
Percentage of Total Revenues
($ in thousands)
 
June 30,
2012
 
June 30,
2011
 
$ Change
 
% Change
 
June 30,
2012
 
June 30,
2011
Selling, general and administrative:
 
 
 
 
 
 
 
 
 
 
 
 
   Par Pharmaceutical
 
$
25,681

 
$
24,515

 
$
1,166

 
4.8
 %
 
9.4
%
 
12.1
%
   Strativa
 
13,986

 
21,641

 
(7,655
)
 
(35.4
)%
 
65.9
%
 
99.5
%
Total selling, general and administrative
 
$
39,667

 
$
46,156

 
$
(6,489
)
 
(14.1
)%
 
13.5
%
 
20.6
%


The net decrease in SG&A expenditures for the three month period ended June 30, 2012 principally reflects:
a $5.6 million reduction in direct Strativa selling costs driven by a 90 person reduction of headcount and the termination of

43


marketing for Zuplenz® and Oravig® resulting from our second quarter 2011 restructuring activities;
$3.5 million of lower legal spend; somewhat tempered by,
$1.3 million of incremental employment and related costs principally associated with our November 17, 2011 acquisition of Anchen Pharmaceuticals, Inc.

 
 
Six months ended
 
 
 
 
 
 
 
 
 
 
Percentage of Total Revenues
($ in thousands)
 
June 30,
2012
 
June 30,
2011
 
$ Change
 
% Change
 
June 30,
2012
 
June 30,
2011
Selling, general and administrative:
 
 
 
 
 
 
 
 
 
 
 
 
   Par Pharmaceutical
 
$
52,431

 
$
49,183

 
$
3,248

 
6.6
 %
 
10.0
%
 
11.9
%
   Strativa
 
29,395

 
43,918

 
(14,523
)
 
(33.1
)%
 
70.8
%
 
97.7
%
Total selling, general and administrative
 
$
81,826

 
$
93,101

 
$
(11,275
)
 
(12.1
)%
 
14.5
%
 
20.4
%

The net decrease in SG&A expenditures for the six month period ended June 30, 2012 principally reflects:
a $10.1 million reduction in direct Strativa selling costs driven by a 90 person reduction of headcount and the termination of marketing for Zuplenz® and Oravig® resulting from our second quarter 2011 restructuring activities;
$8.5 million of lower legal spend; somewhat tempered by,
$3.1 million of incremental employment and related costs principally associated with our November 17, 2011 acquisition of Anchen Pharmaceuticals, Inc.; and
a $1.6 million increase in consulting and accounting fees principally in conjunction with the Anchen and Edict acquisitions and the recently announced proposed acquisition of Par by TGP (refer to Note 19 - Subsequent Events contained elsewhere in this Form 10-Q for further details).


Intangible Assets Impairment

During the three months ended March 31, 2012, we abandoned an in-process research and development project acquired in the Anchen Acquisition and recorded a corresponding intangible asset impairment of $2 million.
   

Settlements and Loss Contingencies, net

 
 
Three months ended
 
Six months ended
($ in thousands)
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Settlements and loss contingencies, net
 
$

 
$

 
$
45,000

 
$
190,560


During the three months ended March 31, 2012, we recorded an accrual of $45 million as management's best estimate of potential loss related to a potential global settlement with respect to an inquiry by the Department of Justice into our promotional practices in the sales and marketing of Megace® ES.  Refer to Note 16 - Commitments, Contingencies and Other Matters contained elsewhere in this Form 10-Q for further details.  
In first quarter of 2011, we recorded the settlement in principal of AWP litigation claims related to federal contributions to state Medicaid programs in 49 states (excluding Illinois), and the claims of Texas, Florida, Alaska, South Carolina and Kentucky relating to their Medicaid programs for $154 million and a settlement with the State of Idaho for $1.7 million.  We also recorded an accrual for the remaining AWP matters.  Refer to Note 16 - Commitments, Contingencies and Other Matters contained elsewhere in this Form 10-Q for further details.

Restructuring costs
 
 
Three months ended
 
Six months ended
($ in thousands)
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Restructuring costs
 
$

 
$
26,986

 
$

 
$
26,986


44



In June 2011, we announced our plans to resize our branded products division, Strativa Pharmaceuticals, as part of a strategic assessment. We reduced our Strativa workforce by approximately 90 people and discontinued the marketing of two brands. In conjunction with these actions, we incurred expenses for severance and other employee-related costs, intangible asset impairments and inventory write downs. The total restructuring charge was reflected on the condensed consolidated statements of operations for the quarter ended June 30, 2011.

Operating Income

 
 
Three months ended
($ in thousands)
 
June 30,
2012
 
June 30,
2011
 
$ Change
Operating income (loss):
 
 
 
 
 
 
   Par Pharmaceutical
 
$
81,408

 
$
51,845

 
$
29,563

   Strativa
 
1,363

 
(34,038
)
 
35,401

Total operating income
 
$
82,771

 
$
17,807

 
$
64,964


For the three months ended June 30, 2012, the increase in our operating income as compared to prior year was primarily due an increase in Par Pharmaceutical gross margin and the non-recurrence of the Strativa restructuring related charges, tempered by an increase in Research and Development activity.

 
 
Six months ended
($ in thousands)
 
June 30,
2012
 
June 30,
2011
 
$ Change
Operating income (loss):
 
 
 
 
 
 
   Par Pharmaceutical
 
$
105,456

 
$
(80,901
)
 
$
186,357

   Strativa
 
(43,898
)
 
(39,854
)
 
(4,044
)
Total operating income (loss)
 
$
61,558

 
$
(120,755
)
 
$
182,313


For the six months ended June 30, 2012, the increase in our operating income as compared to prior year was primarily due to the non-recurrence of AWP settlement related accruals, an increase in Par Pharmaceutical gross margin and the non-recurrence of the Strativa restructuring related charges, tempered by the current year accrual related to a Department of Justice investigation and an increase in Research and Development activity.


Interest Income

 
 
Three months ended
 
Six months ended
($ in thousands)
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Interest income
 
$
140

 
$
382

 
$
276

 
$
805


Interest income principally includes interest income derived from money market and other short-term investments.


Interest Expense

 
 
Three months ended
 
Six months ended
($ in thousands)
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Interest expense
 
$
(3,069
)
 
$
(150
)
 
$
(6,163
)
 
$
(301
)



45


In November of 2011, and in connection with the Anchen Acquisition, we entered into a new credit agreement (the "Credit Agreement") with a syndicate of banks to provide senior credit facilities comprised of a five-year Term Loan Facility in an initial aggregate principal amount of $350 million and a five-year Revolving Credit Facility in an initial amount of $100 million.  Interest expense for the three and six month period ended June 30, 2012 is principally comprised of interest on such term loan. Interest expense for the three and six month period ended June 30, 2011, was comprised of amortization of deferred financing costs relating to our October 1, 2010 unsecured credit facility (which was terminated and replaced in conjunction with the November 2011 credit agreement).

Income Taxes

 
 
Three months ended
 
Six months ended
($ in thousands)
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Provision (benefit) for income taxes
 
$
28,537

 
$
8,859

 
$
33,062

 
$
(20,587
)
Effective tax rate
 
36
%
 
49
%
 
59
%
 
17
%

The income tax provision (benefit) was based on the applicable federal and state tax rates for those periods (see Notes to Condensed Consolidated Financial Statements - Note 11 - “Income Taxes”). The effective tax rate for the three months ended June 30, 2012 reflects our estimate of the non-deductibility of our portion of the annual pharmaceutical manufacturer fee under the Patient Protection and Affordable Care Act, offset by benefit for tax deductions specific to U.S. domestic manufacturing companies. The effective tax rate for the six months ended June 30, 2012 reflects our estimate of the portion of loss contingencies provided for in the quarter which may not be tax deductible and by non-deductibility of our portion of the annual pharmaceutical manufacturer fee under the Patient Protection and Affordable Care Act, offset by benefit for tax deductions specific to U.S. domestic manufacturing companies.

Discontinued Operations

 
 
Three months ended
 
Six months ended
($ in thousands)
 
June 30,
2012
 
June 30,
2011
 
June 30,
2012
 
June 30,
2011
Provision for income taxes
 
$
28

 
$
127

 
$
55

 
$
253

Loss from discontinued operations
 
$
(28
)
 
$
(127
)
 
$
(55
)
 
$
(253
)


In January 2006, we announced the divestiture of FineTech Laboratories, Ltd (“FineTech”), effective December 31, 2005.  In the periods presented we recorded tax amounts to discontinued operations for interest related to contingent tax liabilities.  The results of FineTech operations have been classified as discontinued for all periods presented because we had no continuing involvement in FineTech.

FINANCIAL CONDITION

Liquidity and Capital Resources  

 
 
Six months ended
($ in thousands)
 
June 30,
2012
Cash and cash equivalents at beginning of period
 
$
162,516

Net cash provided by operating activities
 
102,446

Net cash used in investing activities
 
(22,950
)
Net cash used in financing activities
 
(485
)
Net increase in cash and cash equivalents
 
$
79,011

Cash and cash equivalents at end of period
 
$
241,527



46


Cash provided by operations for the six months ended June 30, 2012, reflects gross margin dollars generated from revenues (primarily from modafinil) coupled with inventory draw downs and lower outflows to distribution partners and other third parties as more revenues were generated from non-partnered products.  Cash flows used in investing activities were primarily driven by the Edict Acquisition and capital expenditures.  Cash used in financing activities in the six month period ended June 30, 2012 mainly represented the scheduled principal payments under the Term Loan Facility, coupled with the payment of withholding taxes related to the vesting of restricted shares tempered by proceeds from stock option exercises coupled with excess tax benefits on share-based compensation as actual tax benefits exceeded the projected benefits as the value of vested restricted shares exceeded their grant date value.       
Our working capital, current assets minus current liabilities, of $287 million at June 30, 2012 increased approximately $15 million from $272 million at December 31, 2011, which primarily reflects the cash generated by operations tempered by the accrual of $45 million during the three months ended March 31, 2012 related to a potential global settlement of a Department of Justice investigation into Strativa’s marketing of Megace® ES coupled with approximately $12 million of contingent purchase price liabilities incurred with the Edict Acquisition.  The working capital ratio, which is calculated by dividing current assets by current liabilities, was 1.96x at June 30, 2012 compared to 2.08x at December 31, 2011.  We believe that our working capital ratio indicates the ability to meet our ongoing and foreseeable obligations for at least the next 12 fiscal months.  

Detail of Operating Cash Flows

 
 
Six months ended
($ in thousands)
 
June 30,
2012
 
June 30,
2011
Cash received from customers, royalties and other
 
$
579,983

 
$
469,018

Cash paid for inventory
 
(92,786
)
 
(71,007
)
Cash paid to employees
 
(41,904
)
 
(43,363
)
Cash paid to all other suppliers and third parties
 
(331,939
)
 
(246,430
)
Interest (paid) received, net
 
(4,015
)
 
1,042

Income taxes paid, net
 
(6,893
)
 
(9,120
)
Net cash provided by operating activities
 
$
102,446

 
$
100,140


Sources of Liquidity
Our primary source of liquidity is cash received from customers.  The increase in net cash provided by operating activities for the six months ended June 30, 2012 as compared to the prior year comparable period can be primarily attributed to higher cash receipts from customers driven primarily by the launches of modafinil in April 2012, budesonide in June 2011, coupled with revenues from the products acquired in the Anchen Acquisition on November 17, 2011, primarily bupropion ER and zolpidem tempered by higher payments to non-inventory suppliers and other third parties such as development and distribution partners.  Our ability to continue to generate cash from operations is predicated not only on our ability to maintain a sustainable amount of sales of our current product portfolio, but also our ability to monetize our product pipeline and future products that we may acquire.  Our Par generic product pipeline consisted of approximately 72 ANDAs pending with the FDA, including 23 first-to-file opportunities.  Our future profitability depends, to a significant extent, upon our ability to introduce, on a timely basis, new generic products that are either the first to market (or among the first to market) or otherwise can gain significant market share.  No assurances can be given that we or any of our strategic partners will successfully complete the development of any of these potential products either under development or proposed for development, that regulatory approvals will be granted for any such product, that any approved product will be produced in commercial quantities or that any approved product will be sold profitably.  Commercializing brand pharmaceutical products is more costly than generic products.  We cannot be certain that our brand product expenditures will result in the successful development or launch of brand products that will prove to be commercially successful or will improve the long-term profitability of our business.  
On November 17, 2011 we entered into a credit agreement with a syndicate of banks, led by JPMorgan Chase Bank, N.A., as Administrative Agent, U.S. Bank National Association and PNC Bank, National Association as Co-Syndication Agents, DnB NOR Bank ASA and SunTrust Bank as Co-Documentation Agents, J.P. Morgan Securities LLC as Sole Bookrunner, and J.P. Morgan Securities LLC, U.S. Bank National Association and PNC Bank Capital markets LLC as Joint Lead Arrangers, to provide senior unsecured credit facilities comprised of a five-year Term Loan Facility in an initial aggregate principal amount of $350 million and a five-year Revolving Credit Facility in an initial amount of $100 million.  We used the proceeds of the Term Loan Facility, together with cash on hand, to finance the Anchen Acquisition, and the proceeds of the Revolving Credit Facility are available for general corporate purposes.  The credit agreement includes an expansion feature

47


pursuant to which we can increase the amount available to be borrowed by up to an additional $150 million under certain circumstances.  As of June 30, 2012, there was $337 million outstanding under the Term Loan Facility while no amounts were outstanding under the Revolving Credit Facility.  We did not have any borrowings under the Revolving Credit Facility during the six months ended June 30, 2012.  
Uses of Liquidity
Our uses of liquidity and future and potential uses of liquidity include the following:
$413 million paid for the Anchen Acquisition in the fourth quarter of 2011.  
The payment of the $154 million settlement for certain AWP litigation matters (specifically, claims related to federal contributions to state Medicaid programs in 49 states (excluding Illinois), and the claims of Texas, Florida, Alaska, South Carolina and Kentucky relating to their Medicaid programs) in the third quarter of 2011.  In addition, on June 2, 2011, we reached a settlement in principle to resolve claims brought by the city of New York, New York Counties and the state of Iowa under respective state law for $23 million.  The Mississippi suit was settled and paid in September 2011 for $3.6 million.  On October 18, 2011, we reached an agreement in principle to settle the Oklahoma suit for $0.9 million.    
Potential liabilities related to the outcomes of litigation, such as the remaining AWP matters, or the outcomes of investigations by federal authorities, such as the Department of Justice.  In the event that we experience a significant loss, such loss may result in a material impact on our liquidity or financial condition when such liability is paid.  We recorded an accrual of $45 million during the three months ended March 31, 2012 related to a potential global settlement in connection with a litigation or regulatory matter of a Department of Justice investigation into Strativa’s marketing of Megace® ES.  
Cash paid for inventory purchases as detailed in “Details of Operating Cash Flows” above.  The increase reflects the increase in net product sales for the 2012 year-to-date period as compared to the prior year period.
Cash paid to all other suppliers and third parties as detailed in “Details of Operating Cash Flows” above.   The increase is mainly due to higher payments to non-inventory suppliers and other third parties such as development and distribution partners.     
Cash compensation paid to employees as detailed in “Details of Operating Cash Flows” above.         
Potential liabilities related to the outcomes of audits by regulatory agencies like the IRS.  In the event that our loss contingency is ultimately determined to be higher than originally accrued, the recording of the additional liability may result in a material impact on our liquidity or financial condition when such additional liability is paid.  
2012 capital expenditures including approximately $8 million incurred as of June 30, 2012.  
$36.6 million in total purchase price for the Edict Acquisition that was completed on February 17, 2012.  
Expenditures related to current business development and product acquisition activities.  As of June 30, 2012, the total potential future payments that ultimately could be due under existing agreements related to products in various stages of development were approximately $13.2 million.  This amount is exclusive of contingent payments tied to the achievement of sales milestones, which cannot be determined at this time and would be funded through future revenue streams.  
Normal course payables due to distribution agreement partners of approximately $65.0 million as of June 30, 2012 related primarily to amounts due under profit sharing agreements.  We expect to pay substantially all of the $65.0 million during the first two months of the third quarter of 2012.  The risk of lower cash receipts from customers due to potential decreases in revenues associated with competition or supply issues related to partnered products, in particular metoprolol and budesonide, would be mitigated by proportional decreases in amounts payable to distribution agreement partners.  
We believe that we will be able to monetize our current product portfolio, our product pipeline, and future product acquisitions and generate sufficient operating cash flows that, along with existing cash, cash equivalents and available for sale securities, will allow us to meet our financial obligations over the foreseeable future.  We expect to continue to fund our operations, including our research and development activities, capital projects, in-licensing product activity and obligations under our existing distribution and development arrangements discussed herein, out of our working capital.  Our future business or product acquisitions may require additional debt and/or equity financing; there can be no assurance that we will be able to obtain any such additional financing when needed on acceptable or favorable terms.

Stock Repurchase Program
In 2007, our Board approved an expansion of our share repurchase program allowing for the repurchase of up to $75.0 million of our common stock.  The repurchases may be made, subject to compliance with applicable securities laws, from time to time in the open market or in privately negotiated transactions.  Shares of common stock acquired through the repurchase

48


program are and will be available for general corporate purposes.  We repurchased 1,643 thousand shares of our common stock for approximately $31.4 million pursuant to the expanded program in 2007.  We did not repurchase any shares of common stock under this authorization in 2008, 2009, 2010, 2011 or the year-to-date period of 2012.  The authorized amount remaining for stock repurchases under the repurchase program was $43.6 million, as of June 30, 2012.  The repurchase program has no expiration date, but would end if our common stock is delisted and we deregister as a public company. For more information, please see our Current Report on form 8-K, filed July 16, 2012.

Analysis of available for sale debt securities held as of June 30, 2012
In addition to our cash and cash equivalents, we had approximately $19.5 million of available for sale marketable debt securities classified as current assets on the condensed consolidated balance sheet as of June 30, 2012.  These available for sale marketable debt securities were all available for immediate sale.  We intend to continue to use our current liquidity to support our Par Pharmaceutical and Strativa businesses, enter into product license arrangements, potentially acquire other complementary businesses and products, and for general corporate purposes.

Contractual Obligations as of June 30, 2012
The dollar values of our material contractual obligations and commercial commitments as of June 30, 2012 were as follows ($ in thousands):
 
 
 
 
Amounts Due by Period
 
 
 
 
Total Monetary
 
 
 
2013 to
 
2015 to
 
2017 and
 
 
Obligation
 
Obligations
 
2012
 
2014
 
2016
 
thereafter
 
Other
AWP settlements in principle
 
$
23,884

 
$
23,884

 
$

 
$

 
$

 
$

Operating leases
 
23,592

 
2,680

 
9,617

 
5,935

 
5,360

 

Senior credit facilities (3)
 
336,875

 
13,125

 
96,250

 
227,500

 

 

Interest payments (3)
 
36,018

 
5,070

 
20,393

 
10,555

 

 

Fees related to credit facilities (3)
 
1,913

 
213

 
850

 
850

 

 

Purchase obligations (1)
 
102,890

 
102,890

 

 

 

 

Tax liabilities (2)
 
22,291

 
949

 

 

 

 
21,342

Severance payments
 
225

 
195

 
30

 

 

 

Other
 
1,152

 
1,152

 

 

 

 

Total obligations
 
$
548,840

 
$
150,158

 
$
127,140

 
$
244,840

 
$
5,360

 
$
21,342


(1)
Purchase obligations consist of both cancelable and non-cancelable inventory and non-inventory items.  At June 30, 2012 of the total purchase obligations, approximately $20 million related to metoprolol.  
(2)
The difference between a tax position taken or expected to be taken in a tax return and the benefit recognized and measured pursuant to FASB ASC 740-10 Income Taxes represents an unrecognized tax benefit.  An unrecognized tax benefit is a liability that represents a potential future obligation to the taxing authorities.  As of June 30, 2012, the amount represents unrecognized tax benefits, interest and penalties based on evaluation of tax positions and concession on tax issues challenged by the IRS.   For presentation on the table above, we included the related long-term liability in the “Other” column.
(3)
On July 14, 2012, we entered into an Agreement and Plan of Merger (the "Agreement"). We expect this transaction to close before the end of 2012. At closing the senior credit facilities would be paid off and we would no longer be obligated for interest payments and fees related to our existing credit facilities. For more information about the Agreement, please see our Current Report on Form 8-K, filed July 16, 2012.

Financing
Refer to Note 12 – Senior Credit Facility for a description of a senior credit facility we entered into in connection with the Anchen Acquisition.        

Critical Accounting Policies and Use of Estimates
Our critical accounting policies are set forth in our Annual Report on Form 10-K for the fiscal year ended December 31, 2011.  There has been no change, update or revision to our critical accounting policies subsequent to the filing of our Annual Report on Form 10-K for the fiscal year ended December 31, 2011.

49



Subsequent Events

On July 14, 2012, we entered into an Agreement and Plan of Merger (the “Agreement”) with Sky Growth Holdings Corporation, a Delaware corporation (“Parent”), and Sky Growth Acquisition Corporation, a Delaware corporation and a wholly owned subsidiary of Parent (“Merger Sub”). The Agreement provides for the merger of Merger Sub with and into the Company, with the Company surviving the Merger as a wholly-owned subsidiary of Parent (the “Merger”).
Parent and Merger Sub are beneficially owned by affiliates of TPG Capital, L.P. and were formed solely for the purposes of executing the Agreement and facilitating the Merger. The Agreement provides for a purchase price of approximately $1.9 billion for our fully diluted equity. We expect this transaction to close, subject to customary conditions, before the end of 2012. Some of the customary conditions to closing include obtaining the approval of the holders of a majority of the outstanding shares of our common stock and the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
Under the Agreement, we may solicit superior proposals from third parties through August 24, 2012. Parent has certain termination rights that could require us to pay Parent a termination fee of $24 million or $48 million, based on the circumstances of the termination, plus in each case up to $7 million in Parent's expenses. We also have certain termination rights in certain circumstances.
On July 14, 2012, in conjunction with our execution of the Agreement, we modified our Rights Agreement dated as of October 27, 2004, with American Stock Transfer & Trust Company (the “Rights Agreement”), to render the Rights Agreement inapplicable to the Agreement and the Merger and to cause the Rights Agreement to terminate immediately prior to the effective time of the Merger.
For more information about the Merger, the Agreement and our modification of the Rights Agreement, please see our Current Report on Form 8-K, filed July 16, 2012 and our Preliminary Proxy Statement on Schedule 14A, expected to be filed on or about August 2, 2012.  

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Available for sale debt securities   
The primary objectives for our investment portfolio are liquidity and safety of principal. Investments are made with the intention to achieve the best available rate of return on traditionally low risk investments.  We do not buy and sell securities for trading purposes.  Our investment policy limits investments to certain types of instruments issued by institutions with investment-grade credit ratings, the U.S. government and U.S. governmental agencies.  We are subject to market risk primarily from changes in the fair values of our investments in debt securities including governmental agency and municipal securities, and corporate bonds.  These instruments are classified as available for sale securities for financial reporting purposes.  A ten percent increase in interest rates on June 30, 2012 would have caused the fair value of our investments in available for sale debt securities to decline by approximately $0.1 million as of that date.  Additional investments are made in overnight deposits and money market funds. These instruments are classified as cash and cash equivalents for financial reporting purposes, which generally have lower interest rate risk relative to investments in debt securities and changes in interest rates generally have little or no impact on their fair values.  For cash, cash equivalents and available for sale debt securities, a ten percent decrease in interest rates would decrease the interest income we earned by approximately $0.1 million on an annual basis.      
The following table summarizes the carrying value of available for sale securities that subject us to market risk at June 30, 2012 and December 31, 2011 ($ amounts in thousands):

 
June 30,
2012
 
December 31,
2011
Corporate bonds
$
19,459

 
$
25,709

 
Senior Credit Facilities
On November 17, 2011, we entered into a new credit agreement (the "Credit Agreement") with a syndicate of banks, led by JPMorgan Chase Bank, N.A., as Administrative Agent, U.S. Bank National Association and PNC Bank, National Association as Co-Syndication Agents, DnB NOR Bank ASA and SunTrust Bank as Co-Documentation Agents, J.P. Morgan Securities LLC as Sole Bookrunner, and J.P. Morgan Securities LLC, U.S. Bank National Association and PNC Bank Capital Markets LLC as Joint Lead Arrangers, to provide senior credit facilities comprised of a five-year Term Loan Facility in an

50


initial aggregate principal amount of $350 million and a five-year Revolving Credit Facility in an initial amount of $100 million.  Refer to Notes to Consolidated Financial Statements - Note 12 – "Senior Credit Facilities" contained elsewhere in this Form 10-Q for further details.  
The interest rates payable under the Credit Agreement is based on defined published rates plus an applicable margin. During the six months ended June 30, 2012, the effective interest rate on the five-year Term Loan Facility was approximately 2.8%, representing the one month LIBOR spot rate rounded up to the nearest 1/16th plus 250 basis points.  We are also obligated to pay a commitment fee based on the unused portion of the Revolving Credit Facility.  Repayments of the proceeds of the Term Loan Facility are due in quarterly installments over the term of the Credit Agreement.  Amounts borrowed under the Revolving Credit Facility would be payable in full upon expiration of the Credit Agreement.   
If the one month LIBOR spot rate was to increase or decrease by 0.125% from 2012 rates, interest expense would change by approximately $0.4 million on an annual basis.  
The following table summarizes the carrying value of our Senior Credit Facilities that subject us to market risk (interest rate risk) at June 30, 2012 and December 31, 2011:

 
June 30,
2012
 
December 31,
2011
Term Loan Facility
$
336,875

 
$
345,625

Revolving Credit Facility

 

 
336,875

 
345,625

Less current portion
(30,625
)
 
(21,875
)
Long-term debt
$
306,250

 
$
323,750


Debt Maturities as of June 30, 2012
 
($ amounts in thousands)
2012
 
$
13,125

2013
 
39,375

2014
 
56,875

2015
 
96,250

2016
 
131,250

Total debt at June 30, 2012
 
$
336,875


ITEM 4. CONTROLS AND PROCEDURES

Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our filings with the SEC is recorded, processed, summarized and reported within the time period specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer (CEO) and Chief Financial Officer (CFO), as appropriate, to allow timely decisions regarding required disclosure based on the definition of  “disclosure controls and procedures” as defined in Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).  In designing and evaluating disclosure controls and procedures, we have recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply judgment in evaluating our controls and procedures.  A review was performed under the supervision and with the participation of our management, including our CEO and CFO, to assess the effectiveness of the design and operation of our disclosure controls and procedures (as defined under the Exchange Act) as of June 30, 2012.  Based on that review, our management, including our CEO and CFO, concluded that our disclosure controls and procedures were effective as of June 30, 2012.

Changes in Internal Control over Financial Reporting
There have been no changes identified during the quarter ended June 30, 2012 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.  

PART II. OTHER INFORMATION


51


ITEM 1. LEGAL PROCEEDINGS

Legal Proceedings
Unless otherwise indicated in the details provided below, we cannot predict with certainty the outcome or the effects of the litigations described below.  The outcome of these litigations could include substantial damages, the imposition of substantial fines, penalties, and injunctive or administrative remedies; however, unless otherwise indicated below, at this time we are not able to estimate the possible loss or range of loss, if any, associated with these legal proceedings.  From time to time, we may settle or otherwise resolve these matters on terms and conditions that we believe are in the best interests of the Company.  Resolution of any or all claims, investigations, and legal proceedings, individually or in the aggregate, could have a material effect on our results of operations, cash flows or financial condition.  

Corporate Litigation
We and certain of our former executive officers have been named as defendants in consolidated class action lawsuits filed on behalf of purchasers of our common stock between July 23, 2001 and July 5, 2006.  The lawsuits followed our July 5, 2006 announcement regarding the restatement of certain of our financial statements and allege that we and certain members of our then management engaged in violations of the Exchange Act, by issuing false and misleading statements concerning our financial condition and results of operations.  The consolidated class actions are pending in the U.S. District Court for the District of New Jersey.  On July 23, 2008, co-lead plaintiffs filed a Second Consolidated Amended Complaint.  On September 30, 2009, the Court granted a motion to dismiss all claims as against Kenneth Sawyer but denied the motion as to the Company, Dennis O’Connor, and Scott Tarriff.  The co-lead plaintiffs filed a motion to certify the class.  After class discovery, both co-lead plaintiffs withdrew and a new lead plaintiff, Louisiana Municipal Police Employees Retirement Fund (LAMPERS) and its counsel, Berman DeValerio, were substituted in as lead plaintiff and new lead counsel.  LAMPERS filed a motion for class certification, which was granted by the Court on July 23, 2012.  We and Messrs. O'Connor and Tarriff have answered the amended complaint and intend to vigorously defend the consolidated class action.
Between July 24 and July 30, 2012 we, certain of our current directors, TPG Capital L.P. (“TPG Capital”), Sky Growth Holding Corporation (“Sky Holding”), and Sky Growth Acquisition Corporation (“Sky Growth”) (collectively, TPG Capital, Sky Holding, and Sky Growth, shall be referred to as “TPG”) were named as defendants in five class action lawsuits brought by and on behalf of current owners of our common stock. These lawsuits are captioned Nadoff v. Par Pharmaceutical Companies, Inc., et al., C.A. No. 7715-VCP (Del. Ch.), KBC Asset Management N.V. v. Par Pharmaceutical Companies, et al., C.A. No. 7725-VCP (Del. Ch.), Greenberg v. Knight, et al., C.A. No. 7734-VCP (Del. Ch.), Duvall v. Par Pharmaceutical Companies, Inc., et al. No. C-226-12 (N.J. Super. Ct. Ch. Div.) and Wilkinson v. LePore, et al., No. C-229-12 (N.J. Super. Ct. Ch. Div.). These lawsuits follow our July 16, 2012 announcement that we and TPG entered into an Agreement and Plan of Merger (the “Merger Agreement”), pursuant to which TPG will acquire the Company, subject to customary closing conditions including Par stockholder approval.  The lawsuits each allege that the Company's directors have breached their fiduciary duties to the Company's stockholders in connection with the merger. The lawsuits further claim that TPG aided and abetted the directors' alleged breaches of fiduciary duties. The Greenberg and Wilkinson actions also assert an aiding and abetting claim against the Company.  The lawsuits generally seek equitable relief, including an injunction preventing the consummation of the merger, rescission in the event the merger is consummated, invalidation or amendment of deal protections, and an award of attorneys' and other fees and costs. More complaints may be filed going forward. The Company and its directors believe that the claims in each of these lawsuits are without merit, and intend to vigorously defend all pending claims.

Patent Related Matters
On April 28, 2006, CIMA Labs, Inc. and Schwarz Pharma, Inc. filed separate lawsuits against us in the U.S. District Court for the District of New Jersey.  CIMA and Schwarz Pharma each have alleged that we infringed U.S. Patent Nos. 6,024,981 (the “’981 patent”) and 6,221,392 (the “’392 patent”) by submitting a Paragraph IV certification to the FDA for approval of alprazolam orally disintegrating tablets.  CIMA owns the ’981 and ’392 patents and Schwarz Pharma is CIMA’s exclusive licensee.  The two lawsuits were consolidated on January 29, 2007.  In response to the lawsuit, we have answered and counterclaimed denying CIMA’s and Schwarz Pharma’s infringement allegations, asserting that the ’981 and ’392 patents are not infringed and are invalid and/or unenforceable.  On July 10, 2008, the United States Patent and Trademark Office (“USPTO”) rejected all claims pending in both the ‘392 and ‘981 patents.  On September 28, 2009, the USPTO Board of Appeals affirmed the Examiner’s rejection of all claims in the ‘981 patent, and on March 24, 2011, the USPTO Board of Appeals affirmed the rejections pending for both patents and added new grounds for rejection of the ’981 patent.  On June 24, 2011, the plaintiffs re-opened prosecution on both patents at the USPTO.  We intend to vigorously defend this lawsuit and pursue our counterclaims.
We entered into a licensing agreement with developer Paddock Laboratories, Inc. to market testosterone 1% gel, a generic version of Unimed Pharmaceuticals, Inc.’s product Androgel®.  As a result of the filing of an ANDA, Unimed and Laboratories Besins Iscovesco (“Besins”), co-assignees of the patent-in-suit, filed a lawsuit on August 22, 2003 against

52


Paddock in the U.S. District Court for the Northern District of Georgia alleging patent infringement.  On September 13, 2006, we acquired from Paddock all rights to the ANDA for the testosterone 1% gel, and the litigation was resolved by a settlement and license agreement that terminated all on-going litigation and permits us to launch the generic version of the product no earlier than August 31, 2015, and no later than February 28, 2016, assuring our ability to market a generic version of Androgel® well before the expiration of the patents at issue.  On March 7, 2007, we were issued a Civil Investigative Demand seeking information and documents in connection with the 2006 court-approved settlement of the patent dispute.  On January 30, 2009, the Bureau of Competition for the Federal Trade Commission (“FTC”) filed a lawsuit against us in the U.S. District Court for the Central District of California alleging violations of antitrust laws stemming from our court-approved settlement in the Paddock litigation, and several distributors and retailers followed suit with a number of private plaintiffs’ complaints beginning in February 2009.  On April 9, 2009, the U.S. District Court for the Central District of California granted our motion to transfer the FTC lawsuit and the private plaintiffs’ complaints to the U.S. District Court for the Northern District of Georgia.  On February 23, 2010, the District Court granted our motion to dismiss the FTC’s claims and granted in part and denied in part our motion to dismiss the claims of the private plaintiffs.  On June 10, 2010, the FTC appealed the District Court’s dismissal of the FTC’s claims to the U.S. Court of Appeals for the 11th Circuit.  On April 25, 2012, the Court of Appeals affirmed the District Court’s dismissal of the FTC’s claims.  On January 20, 2012, we filed a motion for summary judgment in our lawsuit against the private plaintiffs in the U.S. District Court for the Northern District of Georgia seeking to have their claims of sham litigation dismissed.  We believe we have complied with all applicable laws in connection with the court-approved settlement and intend to continue to vigorously defend these actions.
On November 10, 2011, Celgene and Novartis filed a lawsuit against us in the U.S. District Court for the District of New Jersey, and Alkermes plc (formerly Elan) filed a lawsuit against us in the U.S. District Court for the District of Delaware the following day.  The complaint in the Delaware case alleged infringement of U.S. Patent Nos. 6,228,398 and 6,730,325 because we submitted a Paragraph IV certification to the FDA for approval of 5, 10, 15, 20, 25, 30, and 35 mg dexmethylphenidate hydrochloride extended release capsules.  The complaint in the New Jersey case alleged infringement of U.S. Patent Nos. 5,908,850; 6,355,656; 6,528,530; 5,837,284; 6,635,284; and 7,431,944 because we submitted a Paragraph IV certification to the FDA for approval of 5, 10, 15, 20, 25, 30, 35, and 40 mg dexmethylphenidate extended release capsules.  We intend to vigorously defend and expeditiously resolve these lawsuits.
On September 13, 2007, Santarus, Inc. and The Curators of the University of Missouri (“Missouri”) filed a lawsuit against us in the U.S. District Court for the District of Delaware.  The complaint alleges infringement of U.S. Patent Nos. 6,699,885; 6,489,346; and 6,645,988 because we submitted a Paragraph IV certification to the FDA for approval of 20 mg and 40 mg omeprazole/sodium bicarbonate capsules.  On December 20, 2007, Santarus and Missouri filed a second lawsuit against us in the U.S. District Court for the District of Delaware alleging infringement of the patents because we submitted a Paragraph IV certification to the FDA for approval of 20 mg and 40 mg omeprazole/sodium bicarbonate powders for oral suspension.  On March 4, 2008, the cases pertaining to our ANDAs for omeprazole capsules and omeprazole oral suspension were consolidated for all purposes.  The District Court conducted a bench trial from July 13-17, 2009, and found for Santarus only on the issue of infringement, while not rendering an opinion on the issues of invalidity and unenforceability.  On April 14, 2010, the District Court ruled in our favor, finding that plaintiffs’ patents were invalid as being obvious and without adequate written description.  On May 17, 2010, Santarus filed a notice of appeal to the U.S. Court of Appeals for the Federal Circuit, appealing the District Court’s decision of invalidity of the plaintiffs’ patents.  On May 27, 2010, we filed our notice of cross-appeal to the Court of Appeals, appealing the District Court’s decision of enforceability of plaintiffs’ patents.  On July 1, 2010, we launched our generic Omeprazole/Sodium Bicarbonate product.  Oral argument for the appeal was held on May 2, 2011.  We will continue to vigorously defend the appeal.
On September 20, 2010, Schering-Plough HealthCare Products, Santarus, Inc., and the Curators of the University of Missouri filed a lawsuit against us in the U.S. District Court for the District of New Jersey.  The complaint alleges infringement of U.S. Patent Nos. 6,699,885; 6,489,346; 6,645,988; and 7,399,772 because we submitted an ANDA with a Paragraph IV certification to the FDA for approval of a 20mg/1100 mg omeprazole/sodium bicarbonate capsule, a version of Schering-Plough’s Zegerid OTC®.  We have previously received a decision of invalidity with respect to all of these patents in our case against Santarus and Missouri with respect to the prescription version of this product, which decision is presently on appeal.  On November 9, 2010, we entered into a stipulation with the plaintiffs to stay litigation on the OTC product pending the decision by the U.S. Court of Appeals for the Federal Circuit on the prescription product appeal, and the parties have agreed to be bound by such decision for purposes of the OTC product litigation.  We intend to pursue our appeal and defend this action vigorously.
On December 11, 2007, AstraZeneca Pharmaceuticals, LP, AstraZeneca UK Ltd., IPR Pharmaceuticals, Inc. and Shionogi Seiyaku Kabushiki Kaisha filed a lawsuit against us in the U.S. District Court for the District of Delaware.  The complaint alleges patent infringement because we submitted a Paragraph IV certification to the FDA for approval of 5 mg, 10 mg, 20 mg and 40 mg rosuvastatin calcium tablets.  On June 29, 2010, after an eight day bench trial, the District Court ruled in favor of the plaintiffs and against us, stating that the plaintiffs’ patents were infringed, and not invalid or unenforceable.  On August 11, 2010, we appealed the District Court’s decision to the U.S. Court of Appeals for the Federal Circuit.  An oral

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hearing was conducted October 5, 2011, and we await the decision of the Court of Appeals.  On December 15, 2010, the District Court granted our motion to dismiss a second case brought by AstraZeneca, in which AstraZeneca had asserted that we infringed its rosuvastatin process patents, which decision AstraZeneca appealed to the U.S. Court of Appeals for the Federal Circuit on January 14, 2011.  On February 9, 2012, the Court of Appeals affirmed the Delaware District Court’s dismissal of plaintiffs’ claims in the second action.  We intend to defend both actions vigorously.
On November 14, 2008, Pozen, Inc. filed a lawsuit against us in the U.S. District Court for the Eastern District of Texas.  The complaint alleges infringement of U.S. Patent Nos. 6,060,499; 6,586,458; and 7,332,183, because we submitted a Paragraph IV certification to the FDA for approval of 500 mg/85 mg naproxen sodium/sumatriptan succinate oral tablets.  We joined GlaxoSmithKline (“GSK”) as a counterclaim defendant in this litigation.  On April 28, 2009, GSK was dismissed from the case, but will be bound by the Court’s decision and will be required to produce witnesses and materials during discovery.  A four day bench trial was held from October 12-15, 2010.  On April 14, 2011, the Court granted a preliminary injunction to Pozen that prohibits us from launching our generic naproxen/sumatriptan product before the issuance of a final decision in the case.  On August 5, 2011, the Court ruled in favor of Pozen and against us on infringement, validity, and enforceability.  We filed our appeal brief to the U.S. Court of Appeals for the Federal Circuit on August 31, 2011, and our reply brief on January 20, 2012.  On June 5, 2012, the court issued a per curiam affirmance of the lower court's decision not to award attorneys' fees to one of our co-defendants but, in that decision, did not otherwise reach the merits of our appeal. We intend to vigorously pursue our appeal.   
On April 29, 2009, Pronova BioPharma ASA filed a lawsuit against us in the U.S. District Court for the District of Delaware.  The complaint alleges infringement of U.S. Patent Nos. 5,502,077 and 5,656,667 because we submitted a Paragraph IV certification to the FDA for approval of omega-3-acid ethyl esters oral capsules.  A bench trial took place from March 29, 2011 to April 7, 2011.  On September 29, 2011, we filed our final reply brief with the Court.  We intend to continue to defend this action vigorously and pursue our defenses and counterclaims against Pronova.  During the pendency of this action, on June 8, 2010, a new patent, U.S. 7,732,488, which was later listed in the Orange Book, was issued to Pronova, and Pronova filed a second case, asserting claims of the ’488 patent and two other patents not listed in the Orange Book.  On July 25, 2011, a stipulation was submitted to the court dismissing the second case without prejudice. On May 29, 2012, the Delaware court ruled in favor of Pronova on infringement, validity, and enforceability. On June 25, 2012, we filed our notice of appeal to the Court of Appeals for the Federal Circuit and intend to vigorously prosecute this appeal.
On August 5, 2010, Warner Chilcott and Medeva Pharma filed a lawsuit against us and our partner EMET Pharmaceuticals in the U.S. District Court for the District of New Jersey.  The complaint alleges infringement of U.S. Patent No. 5,541,170 because we submitted an ANDA with a Paragraph IV certification to the FDA for approval of a 400 mg delayed-release oral tablet of mesalamine.  On March 29, 2011, the Court granted plaintiffs’ motion to dismiss our counterclaim for declaratory judgment of non-infringement of U.S. Patent No. 5,541,171.  Our appeal of this decision was docketed with the U.S. Court of Appeals for the Federal Circuit on May 20, 2011.  A Markman hearing was held on October 18, 2011.  An oral hearing was conducted on January 12, 2012, and the Court of Appeals affirmed the District Court’s decision on January 27, 2012.  On June 1, 2012, the court issued a Markman opinion in the case construing the definition of key claim terms delimiting active release and coating solubility.  We intend to defend this action vigorously and pursue all of our defenses and counterclaims against Warner Chilcott and Medeva Pharma.
On October 4, 2010, UCB Manufacturing, Inc. filed a verified complaint in the Superior Court of New Jersey, Chancery Division, Middlesex, naming us, our development partner Tris Pharma, and Tris Pharma’s head of research and development, Yu-Hsing Tu.  The complaint alleges that Tris and Tu misappropriated UCB’s trade secrets and, by their actions, breached contracts and agreements to which UCB, Tris, and Tu were bound.  The complaint further alleges unfair competition against Tris, Tu, and us relating to the parties’ manufacture and marketing of generic Tussionex®.  On October 6, 2010, the Court denied UCB’s petition for a temporary restraining order against us and Tris and set a schedule for discovery during which UCB must substantiate its claims.  On December 23, 2010, the Court denied UCB’s motion for a preliminary injunction, ruling that UCB’s alleged trade secrets were known to the public and not misappropriated.  On June 2, 2011, the Court granted Tris’s motion for summary judgment dismissing UCB’s claims, and UCB appealed the Court’s order on June 22, 2011.  We intend to vigorously defend the lawsuit and any appeal by plaintiffs.
On March 25, 2011, Elan Corporation, PLC filed a lawsuit against us and our development partners, IntelliPharmaceutics Corp. and IntelliPharmaCeutics Ltd. (collectively “IPC”) in the U.S. District Court for the District of Delaware, and Celgene Corporation and Novartis filed a lawsuit against IPC in the U.S. District Court for the District of New Jersey.  The complaint in the Delaware case alleges infringement of U.S. Patent Nos. 6,228,398 and 6,730,325 because we submitted a Paragraph IV certification to the FDA for approval of 30 mg dexmethylphenidate hydrochloride extended release capsules.  The complaint in the New Jersey case alleges infringement of U.S. Patent Nos. 6,228,398; 6,730,325; 5,908,850; 6,355,656; 6,528,530; 5,837,284; and 6,635,284 because we submitted a Paragraph IV certification to the FDA for approval of 30 mg dexmethylphenidate extended release capsules.  On July 17, 2012, a stipulation and order to stay the case in Delaware was entered pending regulatory review of a pending settlement between us and the Delaware plaintiffs. We intend to vigorously defend and expeditiously resolve these lawsuits.

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On May 27, 2011, Elan Corporation, PLC filed a lawsuit against us in the U.S. District Court for the District of Delaware, and Celgene Corporation and Novartis filed a lawsuit against us in the U.S. District Court for the District of New Jersey.  The complaint in the Delaware case alleges infringement of U.S. Patent Nos. 6,228,398 and 6,730,325 because we submitted a Paragraph IV certification to the FDA for approval of 40 mg dexmethylphenidate hydrochloride extended release capsules.  The complaint in the New Jersey case alleges infringement of U.S. Patent Nos. 6,228,398; 6,730,325; 5,908,850; 6,355,656; 6,528,530; 5,837,284; and 6,635,284 because we submitted a Paragraph IV certification to the FDA for approval of 40 mg dexmethylphenidate extended release capsules.  On July 17, 2012, a stipulation and order to stay the case in Delaware was entered pending regulatory review of a pending settlement between us and the Delaware plaintiffs. We intend to vigorously defend and expeditiously resolve these lawsuits.
On August 10, 2011, Avanir Pharmaceuticals, Inc. et al. filed a lawsuit against us in the U.S. District Court for the District of Delaware.  The complaint alleges infringement of U.S. Patent Nos. 7,659,282 and RE38,155 because we submitted an ANDA with a Paragraph IV certification to the FDA for approval of oral capsules of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate.  We filed our answer on September 6, 2011, and our case was consolidated with those for the other defendants, Actavis, Impax, and Wockhardt, on September 26, 2011.  The Court has scheduled a Markman hearing for October 5, 2012, and a 10-day bench trial for September 9, 2013. On June 15, 2012, the cases of all current generic defendants were consolidated for all purposes. We intend to defend this action vigorously.
On February 2, 2011, Somaxon Pharmaceuticals filed a lawsuit against us in the U.S. District Court for the District of Delaware.  The complaint alleges infringement of U.S. Patent No. 6,211,229 because we submitted an ANDA with a Paragraph IV certification to the FDA for approval of oral tablets of 3 mg equivalent and 6 mg equivalent doxepin hydrochloride.  We filed our answer on February 23, 2011.  Our case has been consolidated in the same Court with those of the other defendants who filed ANDAs on this product.  The Court has scheduled fact discovery to end on April 6, 2012; expert discovery to end on August 17, 2012; the end of Markman briefing for October 12, 2012; and a trial date of December 10, 2012.  On July 17, 2012, Somaxon announced our settlement of the litigation pursuant to a license agreement permitting date certain entry in 2020 or earlier in certain circumstances.
On September 1, 2011, we, along with EDT Pharma Holdings Ltd. (now known as Alkermes Pharma Ireland Limited) (Elan), filed a complaint against TWi Pharmaceuticals, Inc. in the U.S. District Court for the District of Maryland and another complaint against TWi on September 2, 2011, in the U.S. District Court for the Northern District of Illinois.  In both complaints, Elan and we allege infringement of U.S. Patent No. 7,101,576 (expiration April 22, 2024) in view of the notice letter we received from TWi stating that TWi had filed an ANDA, accompanied by a Paragraph IV certification, seeking approval for a generic version of Megace® ES.  We are at present aware of no other generic filers.  On November 15, 2011, the Court scheduled the end of fact discovery for September 1, 2012; the end of expert discovery for December 15, 2012; and a 5-7 day bench trial for October 7, 2013.  We intend to prosecute this infringement case vigorously.
On April 8, 2010, AstraZeneca filed a lawsuit against Anchen Incorporated (now a subsidiary of Par Pharmaceutical, Inc.) in the U.S. District Court for the District of New Jersey.  The complaint alleges infringement of U.S. Patent No. 5,948,437 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of extended-release oral tablets of 150, 200, 300, and 400 mg quetiapine.  A Markman hearing was conducted on November 30, 2010 and a bench trial was held from October 3-19, 2011.  On March 29, 2012, the court ruled in favor of AstraZeneca on invalidity and infringement, enjoining final approval for any generic defendant until May 28, 2017.  While other co-defendants have appealed the decision, we have chosen not to join the appeal.
On June 10, 2010, Genzyme Corporation filed a lawsuit against Anchen in the U.S. District Court for the District of Delaware.  The complaint alleges infringement of U.S. Patent Nos. 5,602,116, and 6,903,083 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of oral capsules of 0.5, 1, and 2.5 mcg doxercalciferol.  A bench trial was conducted from November 14-18, 2011.  On June 11, 2012, the court issued a decision in favor of Sanofi (the acquirer of Genzyme) on infringement and validity. While other co-defendants have appealed, we have chosen not to join the appeal.
On June 14, 2010, Abbott Laboratories and Fournier Laboratories Ireland Ltd. filed a lawsuit against Anchen in the U.S. District Court for the District of New Jersey.  The complaint alleges infringement of U.S. Patent No. 7,259,186 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of delayed-release oral capsules of EQ 45 and EQ 135 mg choline fenofibrate.  On April 18, 2012, the Court entered a stipulation and dismissal of the case.  
On January 12, 2011, GlaxoSmithKline, LLC filed a lawsuit against Anchen in the U.S. District Court for the District of Delaware.  The complaint alleges infringement of U.S. Patent No. 5,565,467 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of an oral capsule of 0.5 mg dutasteride and an oral capsule of 0.5/0.4 mg dutasteride/tamsulosin.  On November 30, 2011, the court confirmed that the bench trial for this case is set for October 22, 2012.  We will continue to defend this action vigorously.
On February 23, 2011, Takeda Pharmaceuticals Co., Ltd., Takeda Pharmaceuticals North America, Inc., Takeda Pharmaceuticals, LLC, and Takeda Pharmaceuticals America, Inc. filed suit against Handa Pharmaceuticals, LLC in the United

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States District Court for the Northern District of California.  The complaint alleged infringement of U.S. Patent Nos. 6,462,058; 6,664,276; 6,939,971; 7,285,668; and 7,790,755 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of 30 mg and 60 mg dexlansoprazole delayed-release capsules.  On March 12, 2012, we acquired this ANDA under an exclusive acquisition and license agreement, which requires us to manage and fund the on-going patent litigation.  On April 11, 2012, the court issued a claim construction opinion that largely adopted the constructions proposed by plaintiffs.  A trial is scheduled for June 3, 2013.  We intend to vigorously defend this action.
On September 9, 2011, Flamel Technologies, S.A. filed a lawsuit against Anchen in the U.S. District Court for the District of Maryland.  The complaint alleges infringement of U.S. Patent No. 6,022,562 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of extended-release oral capsules of 10, 20, 40, and 80 mg carvedilol.  The complaint was served on us on January 12, 2012, and we filed our answer on January 30, 2012.  On June 5, 2012, the case was dismissed pursuant to stipulation as between the parties, in addition to a stipulation of dismissal of the third party complaint against GlaxoSmithKline.
On October 28, 2011, Astra Zeneca, Pozen, Inc., and KBI-E Inc., filed a lawsuit against Anchen in the U.S. District Court for the District of New Jersey.  The complaint alleges infringement of U.S. Patent No. 6,926,907; 6,369,085; 7,411,070; and 7,745,466 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of delayed-release oral tablets of 375/20 and 500/20 mg naproxen/esomeprazole magnesium.  We filed our answer on December 12, 2011.  On June 11, 2012, our case was consolidated with those of the other standing generic defendants for all purposes. We will continue to defend this action vigorously.  
On March 28, 2012, Horizon Pharma Inc. and Horizon Pharma USA Inc. filed a lawsuit against us in the U.S. District Court for the District of Delaware.  The complaint alleges infringement of U.S. Patent No. 8,067,033 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of oral tablets of 26.6/800 mg famotidine/ibuprofen. On April 26, 2012, we filed our answer and counterclaims. We intend to defend this action vigorously.
On April 4, 2012, AR Holding Company, Inc. filed a lawsuit against us in the U.S. District Court for the District of Delaware.  The complaint alleges infringement of U.S. Patent Nos. 7,619,004; 7,601,758; 7,820,681; 7,915,269; 7,964,647; 7,964,648; 7,981,938; 8,093,296; 8,093,297; and 8,097,655 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of oral tablets of 0.6 mg colchicine.  On April 26, 2012, we filed our answer and counterclaims. We intend to defend this action vigorously.
On April 10, 2012, Depomed Inc. filed a lawsuit against us in the U.S. District Court for the District of New Jersey.  The complaint alleges infringement of U.S. Patent Nos. 6,340,375; 6,488,962; 6,635,280; 6,723,340; 7,438,927; and 7,731,989 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of oral tablets of 300 and 600 mg gabapentin. We filed our answer on May 3, 2012. We intend to defend this action vigorously.
On July 20, 2011, Nautilus Neurosciences, Inc. and APR Applied Pharma Research SA, filed a lawsuit against Edict Pharmaceuticals Pvt. Ltd. (now Par Formulations Pvt. Ltd.) in the U.S. District Court for the District of New Jersey.  The complaint alleges infringement of U.S. Patent Nos. 6,974,595; 7,482,377; and 7,759,394 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of diclofenac potassium for oral solution 50 mg.  We intend to defend this action vigorously.

On June 22, 2012, Pfizer, Inc., Wyeth, LLC et al. filed lawsuits against the Company in the U.S. District Courts for the District of Delaware and the Central District of California. The complaints allege infringement of U.S. Patent No. 6,673,838 for submitting an ANDA with a Paragraph IV certification to the FDA for approval of O-desmethylvenlafaxine succinate extended release tablets 50 mg and 100 mg. We intend to defend this action vigorously.

Industry Related Matters
Beginning in September 2003, we, along with numerous other pharmaceutical companies, have been named as a defendant in actions brought by the Attorneys General of Illinois, Kansas, Louisiana, and Utah, as well as a state law qui tam action brought on behalf of the state of Wisconsin by Peggy Lautenschlager and Bauer & Bach, LLC, alleging generally that the defendants defrauded the state Medicaid systems by purportedly reporting “Average Wholesale Prices” (“AWP”) and/or “Wholesale Acquisition Costs” that exceeded the actual selling price of the defendants’ prescription drugs.  These cases generally seek some combination of actual damages, and/or double damages, treble damages, compensatory damages, statutory damages, civil penalties, disgorgement of excessive profits, restitution, disbursements, counsel fees and costs, litigation expenses, investigative costs, injunctive relief, punitive damages, imposition of a constructive trust, accounting of profits or gains derived through the alleged conduct, expert fees, interest and other relief that the court deems proper.  To date, we have settled the lawsuits brought by the states of Alabama, Alaska, Florida, Hawaii, Idaho, Kentucky, Massachusetts, Mississippi, South Carolina, and Texas, as well as the federal qui tam action brought on behalf of the United States by the pharmacy Ven-A-Care of the Florida Keys, Inc.  On June 2, 2011, we reached a settlement in principle to resolve claims brought by the city of New York, New York Counties and the state of Iowa under respective state law for $23,000 thousand.  On October 18, 2011,

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we reached an agreement in principle to settle the Oklahoma suit for $884 thousand.  We have accrued a $37,800 thousand reserve under the caption “Accrued legal settlements” on our consolidated balance sheet as of June 30, 2012, in connection with the June 2, 2011 settlement in principle and the remaining AWP actions.  In the Utah suit, the time for responding to the complaint has not yet elapsed.  In each of the remaining matters, we have either moved to dismiss the complaints or answered the complaints denying liability.  We will continue to defend or explore settlement opportunities in other jurisdictions as we feel are in our best interest under the circumstances presented in those jurisdictions.  However, we can give no assurance that we will be able to settle the remaining actions on terms that we deem reasonable, or that such settlements or adverse judgments, if entered, will not exceed the amount of the reserve.
The Attorneys General of Florida, Indiana and Virginia and the United States Office of Personnel Management (the “USOPM”) have issued subpoenas, and the Attorneys General of Michigan, Tennessee, Texas, and Utah have issued civil investigative demands, to us.  The demands generally request documents and information pertaining to allegations that certain of our sales and marketing practices caused pharmacies to substitute ranitidine capsules for ranitidine tablets, fluoxetine tablets for fluoxetine capsules, and two 7.5 mg buspirone tablets for one 15 mg buspirone tablet, under circumstances in which some state Medicaid programs at various times reimbursed the new dosage form at a higher rate than the dosage form being substituted.  We have provided documents in response to these subpoenas to the respective Attorneys General and the USOPM. The aforementioned subpoenas and civil investigative demands culminated in the federal and state law qui tam action brought on behalf of the United States and several states by Bernard Lisitza.  The complaint was unsealed on August 30, 2011.  The United States intervened in this action on July 8, 2011 and filed a separate complaint on September 9, 2011, alleging claims for violations of the Federal False Claims Act and common law fraud.  The states of Michigan and Indiana have also intervened as to claims arising under their respective state false claims acts, common law fraud, and unjust enrichment. On July 13, 2012, we filed an Answer and Affirmative Defense to Indiana's Amended Complaint. We intend to vigorously defend these lawsuits.
We have also been named a defendant in a putative federal class action brought by the United Food and Commercial Workers Unions and Employers Midwest Health Benefits Fund (“UFCW”) under the Federal Racketeer Influenced and Corrupt Organizations Act alleging the same general conduct as set forth in the preceding paragraph.  We filed a motion to dismiss the complaint brought by UFCW on March 26, 2012, and the motion to dismiss was granted on July 16, 2012.  

Department of Justice Matter
On March 19, 2009, we were served with a subpoena by the Department of Justice requesting documents related to Strativa’s marketing of Megace® ES.  The subpoena indicated that the Department of Justice is currently investigating promotional practices in the sales and marketing of Megace® ES.  We have cooperated with the Department of Justice in this inquiry and will continue to do so.  Investigations of this type often result in settlements, including monetary amounts based on an agreed upon percentage of sales of the product at issue in the investigation.  We accrued $45,000 thousand in the first quarter of 2012 as management’s best estimate of potential loss related to a potential global settlement in this matter, pending the finalization of definitive settlement terms.

Declaratory Judgment
On October 14, 2011, we filed a declaratory complaint and a motion for preliminary injunction in the U.S. District Court for the District of Columbia seeking to preserve our First Amendment right to provide truthful information to physicians and other healthcare providers about the FDA-approved, on-label use of Megace® ES.
 
Other
We are, from time to time, a party to certain other litigations, including product liability litigations.  We believe that these litigations are part of the ordinary course of our business and that their ultimate resolution will not have a material effect on our financial condition, results of operations or liquidity. We intend to defend or, in cases where we are the plaintiff, to prosecute these litigations vigorously.

ITEM 1A.  RISK FACTORS
In addition to the other information set forth in this Report, you should carefully consider the factors discussed in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2011, which could materially affect our business, results of operations, financial condition or liquidity. The risks described in our Annual Report on Form 10-K for the year ended December 31, 2011 have not materially changed other than as set forth below due to our pending merger with Sky Growth Acquisition Corporation, a Delaware corporation and a wholly owned subsidiary of Sky Growth Holdings Corporation, a Delaware corporation (collectively “Sky Growth”). The Sky Growth entities are beneficially owned by affiliates of TPG Capital, L.P. The risks described in our Annual Report and set forth below are not the only risks facing us. Additional risks and uncertainties not currently known to us, or that we currently believe are immaterial, also may materially adversely affect our business, results of operations, financial condition or liquidity.

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Risks Related to the Merger with Sky Growth
Our pending merger with Sky Growth is not guaranteed to occur. Compliance with the terms of the Merger Agreement in the interim could adversely affect our business. If the merger does not occur, it could have a material and adverse affect on our business, results of operations and our stock price.
On July 14, 2012, the Company, entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Sky Growth Holdings Corporation, a Delaware corporation ("Parent"), and Sky Growth Acquisition Corporation, a Delaware corporation and a wholly owned subsidiary of Parent (“Merger Sub”), providing for the merger of Merger Sub with and into the Company (the “Merger”), with the Company surviving the Merger as a wholly-owned subsidiary of Parent. At the effective time of the Merger, each share of the Company's common stock issued and outstanding immediately prior to the effective time of the Merger will be converted into the right to receive $50.00 in cash (the “Per Share Merger Consideration”). Company stock options, restricted shares, restricted stock units and performance share units will generally be cancelled upon completion of the Merger in exchange for the Per Share Merger Consideration or, in the case of stock options, the excess, if any, of the Per Share Merger Consideration over the exercise price of the option.
Consummation of the Merger is subject to customary conditions, including without limitation: (i) the approval by the holders of a majority of the outstanding shares of the Company's common stock entitled to vote on the Merger (the “Company Required Vote”), (ii) the expiration or early termination of the waiting period applicable to the Merger under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and any required approvals thereunder and (iii) the absence of any law, injunction, judgment or ruling that prohibits, restrains or makes illegal the consummation of the Merger. Moreover, each party's obligation to consummate the Merger is subject to certain other conditions, including without limitation: (x) the accuracy of the other party's representations and warranties contained in the Merger Agreement (subject to materiality qualifiers) and (y) the other party's performance of its obligations under the Merger Agreement in all material respects. In addition, the obligation of Parent and Merger Sub to consummate the Merger is subject to the absence, since the date of the Merger Agreement, of any effect, development, fact, circumstance, change, event or occurrence that, individually or in the aggregate, has had or would reasonably be expected to have a Company Material Adverse Effect (as defined in the Merger Agreement). Parent also is not required to consummate the Merger until after completion of a marketing period for the financing it is using to fund a portion of the merger consideration. 
As a result of the Merger: (i) the attention of management and employees may be diverted from day to day operations as they focus on matters relating to preparation for integrating the Company's operations with those of Parent; (ii) the restrictions and limitations on the conduct of the Company's business pending the Merger may disrupt or otherwise adversely affect its business and our relationships with its customers, and may not be in the best interests of the Company if it were to have to act as an independent entity following a termination of the Merger Agreement; (iii) the Company's ability to retain its existing employees may be adversely affected due to the uncertainties created by the Merger; and (iv) the Company's ability to maintain existing customer relationships, or to establish new ones, may be adversely affected. Any delay in consummating the Merger may exacerbate these issues.
There can be no assurance that all of the conditions to closing will be satisfied, or where possible, waived, or that the Merger will become effective. If the Merger does not become effective because all conditions to closing are not satisfied, or because one of the parties, or all of the parties mutually, terminate the Merger Agreement, then, among other possible adverse effects: (i) the Company's stockholders will not receive the consideration which Parent has agreed to pay; (ii) the Company's stock price may decline significantly; (iii) the Company's business may have been adversely affected; (iv) the Company will have incurred significant transaction costs; and (v) under certain circumstances, the Company may have to pay Parent a termination fee of $24 million or $48 million, plus in each case up to $7 million in Parent's expenses.
 
The pendency of the Merger could materially adversely affect our operations and the future of our business or result in a loss of employees.
 In connection with the pending Merger, it is possible that some customers, suppliers and other persons with whom we have a business relationship may delay or defer certain business decisions or might decide to seek to terminate, change or renegotiate their relationship with us as a result of the Merger, which could negatively impact our revenues, earnings and cash flows, as well as the market price of our common stock, regardless of whether the Merger is completed. Similarly, current and prospective employees may experience uncertainty about their future roles with us following completion of the Merger, which may materially adversely affect our ability to attract and retain key employees.

Failure to complete the Merger could negatively impact our stock price and our future businesses and financial results.
 If the Merger is not completed, our ongoing business may be adversely affected and we will be subject to several risks and consequences, including the following:

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under the Merger Agreement, we may be required, under certain circumstances, to pay a termination fee of either $24 million or $48 million (depending on the circumstances), plus in each case up to $7 million in Parent's expenses:
we may be required to pay certain costs relating to the Merger, whether or not the Merger is completed, such as legal, accounting, financial advisor and printing fees;
under the Merger Agreement, we are subject to certain restrictions on the conduct of our business prior to completing the Merger that may adversely affect our ability to execute certain of our business strategies; and
matters relating to the Merger may require our management to devote substantial commitments of time and resources, which could otherwise have been devoted to other opportunities that may have been beneficial to us.
 In addition, if the Merger is not completed, we may experience negative reactions from the financial markets and from our customers and employees. We also could be subject to litigation related to any failure to complete the Merger or to enforcement proceedings commenced against us to attempt to force us to perform our obligations under the Merger Agreement.



ITEM 2.  UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Issuer Purchases of Equity Securities(1)
Quarter Ending June 30, 2012

Period
 
Total Number of Shares of Common Stock Purchased (2)
 
Average Price Paid per Share of Common Stock
 
Total Number of Shares of Common Stock Purchased as Part of Publicly Announced Plans or Programs
 
Maximum Number of Shares of Common Stock that May Yet Be Purchased Under the Plans or Programs (3)
April 1, 2012 through April 30, 2012
 
105
 
N/A
 
 
May 1, 2012 through May 31, 2012
 
1,062
 
N/A
 
 
June 1, 2012 through June 30, 2012
 
 
N/A
 
 
1,205,285
Total
 
1,167
 
N/A
 
 
 

(1)
In April 2004, the Board authorized the repurchase of up to $50.0 million of our common stock.  Repurchases are made, subject to compliance with applicable securities laws, from time to time in the open market or in privately negotiated transactions, whenever it appears prudent to do so.  Shares of common stock acquired through the repurchase program are available for reissuance for general corporate purposes.  In September 2007, we announced that the Board approved an expansion of our share repurchase program allowing for the repurchase of up to $75 million of our common stock, inclusive of the $17.8 million remaining from the April 2004 authorization.  The authorized amount remaining for stock repurchases under the repurchase program was $43.6 million, as of June 30, 2012.  The repurchase program has no expiration date, but would end if our common stock is delisted and we deregister as a public company. For more information, please see our Current Report on Form 8-K, filed July 16, 2012 and our Preliminary Proxy Statement on Schedule 14A, expected to be filed on or about August 2, 2012.
(2)
The total number of shares purchased represents 1,167 shares surrendered to us to satisfy tax withholding obligations in connection with the vesting of restricted stock issued to employees.
(3)
Based on the closing price of our common stock on the New York Stock Exchange of $36.14 at June 30, 2012.


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ITEM 6. EXHIBITS

 
 
 
31.1
 
Certification of the Principal Executive Officer (filed herewith).
 
 
 
31.2
 
Certification of the Principal Financial Officer (filed herewith).
 
 
 
32.1
 
Certification by the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (attached hereto). *
 
 
 
32.2
 
Certification by the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (attached hereto). *
 
 
 
101
 
The following financial statements and notes from the Par Pharmaceutical Companies, Inc. Quarterly Report on Form 10-Q for the quarter ended June 30, 2012 formatted in eXtensible Business Reporting Language (XBRL): (i) unaudited condensed consolidated balance sheets, (ii) unaudited condensed consolidated statements of operations, (iii) unaudited condensed consolidated statements of comprehensive income (loss), (iv) unaudited condensed consolidated statements of cash flows, and (v) the notes to the unaudited condensed consolidated financial statements.
 
 
 
*
 
The certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed to be filed with the SEC and are not to be incorporated by reference into any filing of ours under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in any such filing.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.



PAR PHARMACEUTICAL COMPANIES, INC.
(Registrant)




Date:  August 2, 2012
/s/ Michael A. Tropiano                                                      
Michael A. Tropiano
Executive Vice President and Chief Financial Officer



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EXHIBIT INDEX

Exhibit Number
 
 
 
31.1
 
Certification of the Principal Executive Officer (filed herewith).
 
 
 
31.2
 
Certification of the Principal Financial Officer (filed herewith).
 
 
 
32.1
 
Certification by the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (attached hereto).
 
 
 
32.2
 
Certification by the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (attached hereto).
 
 
 
101
 
The following financial statements and notes from the Par Pharmaceutical Companies, Inc. Quarterly Report on Form 10-Q for the quarter ended June 30, 2012 formatted in eXtensible Business Reporting Language (XBRL): (i) unaudited condensed consolidated balance sheets, (ii) unaudited condensed consolidated statements of operations, (iii) unaudited condensed consolidated statements of comprehensive income (loss), (iv) unaudited condensed consolidated statements of cash flows, and (v) the notes to the unaudited condensed consolidated financial statements.


62