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EX-32.2 - CERTIFICATION OF THE CHIEF FINANCIAL OFFICER - PAR PHARMACEUTICAL COMPANIES, INC.exhibit32cfo.htm
EX-32.1 - CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER - PAR PHARMACEUTICAL COMPANIES, INC.exhibit32ceo.htm
EX-31.2 - CERTIFICATION OF THE PRINCIPAL EXECUTIVE OFFICER - PAR PHARMACEUTICAL COMPANIES, INC.exhibit31cfocert.htm
EX-31.1 - CERTIFICATION OF THE PRINCIPAL EXECUTIVE OFFICER - PAR PHARMACEUTICAL COMPANIES, INC.exhibit31ceocert.htm




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: March 31, 2011

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 April 27, 2011: 36,208,861











TABLE OF CONTENTS

PAR PHARMACEUTICAL COMPANIES, INC.

FORM 10-Q

FOR THE QUARTER ENDED MARCH 31, 2011


PAGE


PART I   

FINANCIAL INFORMATION



Item 1.

Condensed Consolidated Financial Statements (unaudited)


Condensed Consolidated Balance Sheets as of March 31, 2011 and

December 31, 2010

3


Condensed Consolidated Statements of Operations for the three months

ended March 31, 2011 and March 31, 2010

4


Condensed Consolidated Statements of Cash Flows for the three months

ended March 31, 2011 and March 31, 2010

5


Notes to Condensed Consolidated Financial Statements

6


Item 2.    

Management’s Discussion and Analysis of Financial Condition

and Results of Operations

29


Item 3.

Quantitative and Qualitative Disclosures about Market Risk

43


Item 4.

 Controls and Procedures

44



PART II

OTHER INFORMATION


Item 1.

Legal Proceedings

44


Item 1A.

Risk Factors

48


Item 2.   

Unregistered Sales of Equity Securities and Use of Proceeds

48


Item 6.   

Exhibits

49


SIGNATURES

50




2



PART I - FINANCIAL INFORMATION

ITEM 1.  FINANCIAL STATEMENTS

PAR PHARMACEUTICAL COMPANIES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In Thousands, Except Share Data)

(Unaudited)

 

 

March 31,

 

December 31,

 

 

2011

 

2010

      ASSETS

 

 

 

 

Current assets:

 

 

 

 

    Cash and cash equivalents

 

$

256,173 

 

$

218,674 

    Available for sale marketable debt securities

 

28,371 

 

27,866 

    Accounts receivable, net  

 

117,966 

 

95,705 

    Inventories

 

69,680 

 

72,580 

    Prepaid expenses and other current assets

 

15,295 

 

17,660 

    Deferred income tax assets

 

26,037 

 

26,037 

    Income taxes receivable

 

54,920 

 

18,605 

    Total current assets

 

568,442 

 

477,127 

 

 

 

 

 

Property, plant and equipment, net

 

71,777 

 

71,980 

Intangible assets, net

 

92,362 

 

95,467 

Goodwill

 

63,729 

 

63,729 

Other assets

 

6,298 

 

5,441 

Non-current deferred income tax assets, net

 

77,824 

 

69,488 

Total assets

 

$

880,432 

 

$

783,232 

 

 

 

 

 

      LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

Current liabilities:

 

 

 

 

    Accounts payable

 

$

24,759 

 

$

23,956 

    Payables due to distribution agreement partners

 

31,447 

 

25,310 

    Accrued salaries and employee benefits

 

12,099 

 

16,397 

    Accrued government pricing liabilities

 

30,371 

 

32,169 

    Accrued legal fees

 

12,187 

 

7,084 

    Accrued legal settlements

 

197,100 

 

    Accrued expenses and other current liabilities

 

6,368 

 

6,674 

    Total current liabilities

 

314,331 

 

111,590 

 

 

 

 

 

Long-term liabilities

 

43,794 

 

43,198 

Commitments and contingencies

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

    Common Stock, par value $0.01 per share, authorized 90,000,000 shares; issued

 

 

 

 

         39,349,408 and 38,872,663 shares

 

391 

 

389 

    Additional paid-in capital

 

383,633 

 

373,764 

    Retained earnings

 

220,158 

 

329,129 

    Accumulated other comprehensive gain

 

83 

 

137 

    Treasury stock, at cost 3,167,876 and 2,970,573 shares

 

(81,958)

 

(74,975)

    Total stockholders' equity

 

522,307 

 

628,444 

Total liabilities and stockholders’ equity

 

$

880,432 

 

$

783,232 

 

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

 

March 31,

 

March 31,

 

2011

 

2010

 

 

 

 

Revenues:

 

 

 

    Net product sales

$

220,789 

 

$

288,278 

    Other product related revenues

12,163 

 

3,654 

Total revenues

232,952 

 

291,932 

Cost of goods sold

123,300 

 

208,422 

    Gross margin

109,652 

 

83,510 

Operating expenses:

 

 

 

    Research and development

10,710 

 

4,652 

    Selling, general and administrative

46,945 

 

41,235 

    Settlements and loss contingencies, net

190,560 

 

62 

Total operating expenses

248,215 

 

45,949 

Gain on sale of product rights and other

 

5,775 

Operating (loss) income

(138,563)

 

43,336 

Interest income

423 

 

328 

Interest expense

(150)

 

(908)

(Loss) income from continuing operations before provision
    for income taxes

(138,290)

 

42,756 

(Benefit) provision for income taxes

(29,446)

 

16,330 

(Loss) income from continuing operations

(108,844)

 

26,426 

Discontinued operations:

 

 

 

Provision for income taxes

127 

 

128 

Loss from discontinued operations

(127)

 

(128)

Net (loss) income

($108,971)

 

$

26,298 

 

 

 

 

Basic (loss) earnings per share of common stock:

 

 

 

(Loss) income from continuing operations

($3.07)

 

$

0.78 

Loss from discontinued operations

(0.00)

 

(0.00)

Net (loss) income

($3.07)

 

$

0.78 

 

 

 

 

Diluted (loss) earnings per share of common stock:

 

 

 

(Loss) income from continuing operations

($3.07)

 

$

0.75 

Loss from discontinued operations

(0.00)

 

(0.00)

Net (loss) income

($3.07)

 

$

0.75 

 

 

 

 

Weighted average number of common shares outstanding:

 

 

 

  Basic

35,500 

 

33,929 

  Diluted

35,500 

 

35,070 

 

 

 

 

 

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



4



PAR PHARMACEUTICAL COMPANIES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In Thousands)

(Unaudited)


 

Three Months Ended

 

March 31,

 

March 31,

 

2011

 

2010

Cash flows from operating activities:

 

 

 

Net (loss) income

($108,971)

 

$

26,298 

Deduct: Loss from discontinued operations, net of tax

(127)

 

(128)

(Loss) income from continuing operations

(108,844)

 

26,426 

Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities:

 

 

 

     Deferred income taxes    

(8,306)

 

(477)

     Non-cash interest expense

 

514 

     Depreciation and amortization

6,242 

 

7,498 

     Allowances against accounts receivable

2,756 

 

(9,522)

     Share-based compensation expense

3,167 

 

3,719 

     Tax deficiency on exercises of stock options

(216)

 

     Loss on disposal of fixed assets

40 

 

60 

     Other, net

222 

 

Changes in assets and liabilities:

 

 

 

     Increase in accounts receivable

(25,017)

 

(3,031)

     Decrease in inventories

2,900 

 

13,453 

     Decrease (increase) in prepaid expenses and other assets

1,508 

 

(7,001)

     Increase in accounts payable, accrued expenses and other liabilities

197,338 

 

3,033 

     Increase (decrease) in payables due to distribution agreement partners

6,137 

 

(9,155)

     (Increase) decrease in income taxes receivable/payable

(35,925)

 

11,817 

       Net cash (used in) provided by operating activities

42,002 

 

37,334 

Cash flows from investing activities:

 

 

 

Capital expenditures

(3,628)

 

(1,903)

Purchases of intangibles

 

(500)

Purchases of available for sale debt securities

(7,998)

 

(20,857)

Proceeds from maturity and sale of available for sale marketable debt and equity securities

7,187 

 

11,434 

 Net cash used in investing activities

(4,439)

 

(11,826)

Cash flows from financing activities:

 

 

 

Proceeds from issuances of common stock upon exercise of stock options

5,033 

 

2,140 

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

84 

 

77 

Excess tax benefits on share-based compensation

5,935 

 

328 

Purchase of treasury stock

(6,983)

 

(1,743)

Cash settlement of share-based compensation

(4,133)

 

 Net cash (used in) provided by financing activities

(64)

 

802 

Net increase in cash and cash equivalents

37,499 

 

26,310 

Cash and cash equivalents at beginning of period

218,674 

 

121,668 

Cash and cash equivalents at end of period

$

256,173 

 

$

147,978 

Supplemental disclosure of cash flow information:

 

 

 

Cash paid during the period for:

 

 

 

Income taxes

$

9,075 

 

$

2,539 

Interest paid

$

132 

 

$

686 

Non-cash transactions:  

 

 

 

Capital expenditures incurred but not yet paid

$

121 

 

$

435 

 

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



5



PAR PHARMACEUTICAL COMPANIES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2011

 (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”), acquires (generally through third party development arrangements), 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, products delivered by injection, and products in the semi-solid form of a cream.   


Note 1 - Basis of Presentation:


The accompanying condensed consolidated financial statements at March 31, 2011 and for the three-month periods ended March 31, 2011 and March 31, 2010 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, 2010 was derived from the Company’s audited consolidated financial statements included in the 2010 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 2010 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 – Recent Accounting Pronouncements:

The Financial Accounting Standards Board (“FASB”) has issued Accounting Standard Update (“ASU”) No. 2010-27, Other Expenses (Topic 720): Fees Paid to the Federal Government by Pharmaceutical Manufacturers.  This ASU provides guidance on how pharmaceutical manufacturers should recognize and classify in their income statements fees mandated by the Patient Protection and Affordable Care Act (PPACA) and the Health Care and Education Reconciliation Act, both enacted in March 2010, referred to as the “Acts.”  The Acts impose an annual fee on the pharmaceutical manufacturing industry for each calendar year beginning on or after January 1, 2011.  An entity’s portion of the annual fee is payable no later than September 30 of the applicable calendar year and is not tax deductible.  A portion of the annual fee will be allocated to individual entities on the basis of the amount of their brand prescription drug sales (including authorized generic product sales) for the preceding year as a percentage of the industry’s brand prescription drug sales (including authorized generic product sales) for the same period. An entity’s portion of the annual fee becomes payable to the U.S. Treasury once a pharmaceutical manufacturing entity has a gross receipt from branded prescription drug sales to any specified government program or in accordance with coverage under any government program for each calendar year beginning on or after January 1, 2011.  The amendments in this ASU specify that the liability for the fee should be estimated and recorded in full upon the first qualifying sale with a corresponding deferred cost that is amortized to expense using a straight-line method of allocation unless another method better allocates the fee over the calendar year that it is payable.  The annual fee is classified as an operating expense in the income statement.  The amendments in this ASU were effective for calendar years beginning after December 31, 2010, when the fee initially became effective.  The annual impact of this fee on the pharmaceutical manufacturing industry will be highly variable depending on the volume of our sales of authorized generics and brand products and our ability to share portions of this fee with partners under pre-existing distribution agreements.  Based upon internal estimates of total industry sales into specified government programs, we currently estimate the impact of the pharmaceutical fee on our 2011 net income to be between $0.8 million and $4.6 million.   


The FASB has issued ASU 2010-29, Business Combinations (Topic 805): Disclosure of Supplementary Pro Forma Information for Business Combinations. The amendments in this ASU affect any public entity as defined by Topic 805, Business Combinations, that enters into business combinations that are material on an individual or aggregate basis.  The amendments in this ASU specify that if a public entity presents comparative financial statements, the entity should disclose revenue and earnings of the combined entity as though the business combination(s) that occurred during the current year had occurred as of the beginning of the comparable prior annual reporting period only.  The amendments also expand the supplemental pro forma disclosures to include a description of the nature and amount of material, nonrecurring pro forma adjustments directly attributable to the business combination included in the reported pro forma revenue and earnings.  The amendments are effective prospectively for business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2010.



6



The requirements of this ASU will be applicable to any future business acquisition we complete.  

    

Note 3 - Available for Sale Marketable Debt Securities:

At March 31, 2011 and December 31, 2010, 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 4 - “Fair Value Measurements.”  The following is a summary of amortized cost and estimated fair value of our marketable debt securities available for sale at March 31, 2011 ($ amounts in thousands):

 

 

 

 

 

 

Estimated

 

 

 

 

Unrealized

 

Fair

 

 

Cost

 

Gain

 

(Loss)

 

Value

Corporate bonds

 

$28,238

 

$134

 

($1)

 

$28,371

 

All available for sale marketable debt securities are classified as current on our condensed consolidated balance sheet as of March 31, 2011.


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, 2010 ($ amounts in thousands):

 

 

 

 

 

 

Estimated

 

 

 

 

Unrealized

 

Fair

 

 

Cost

 

Gain

 

(Loss)

 

Value

Corporate bonds

 

$27,654

 

$213

 

($1)

 

$27,866

 

 

The following is a summary of the contractual maturities of our available for sale debt securities at March 31, 2011 ($ amounts in thousands):

 

 

March 31, 2011

 

 

 

 

Estimated Fair

 

 

Cost

 

Value

Less than one year

 

$17,818

 

$17,891

Due between 1-2 years

 

10,420

 

10,480

Total

 

$28,238

 

$28,371


Note 4 – Fair Value Measurements:

FASB Accounting Standards Codification (“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.  

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.



7





The fair value of our financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2011 were as follows ($ amounts in thousands):

 

 

Estimated Fair Value at March 31, 2011

 

Level 1

 

Level 2

 

Level 3

Corporate bonds (Note 3)

 

$28,371

 

$ -

 

$28,371

 

$ -

 

The fair value of our financial assets and liabilities measured at fair value on a recurring basis as of December 31, 2010 were as follows ($ amounts in thousands):

 

 

Estimated Fair Value at December 31, 2010

 

Level 1

 

Level 2

 

Level 3

Corporate bonds (Note 3)

 

$27,866

 

$ -

 

$27,866

 

$ -


Note 5 - 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):


 

 

March 31,

 

December 31,

 

 

2011

 

2010

 

 

 

 

 

Gross trade accounts receivable

 

$

229,012 

 

$

203,995 

Chargebacks

 

(18,415)

 

(19,482)

Rebates and incentive programs

 

(23,954)

 

(23,273)

Returns

 

(51,416)

 

(48,928)

Cash discounts and other

 

(17,261)

 

(16,606)

Allowance for doubtful accounts

 

 

(1)

Accounts receivable, net

 

$

117,966 

 

$

95,705 


Allowance for doubtful accounts

 

Three months ended

 

 

March 31,

 

March 31,

 

 

2011

 

2010

Balance at beginning of period

 

($1)

 

($3)

Additions – charge to expense

 

 

Adjustments and/or deductions

 

 

Balance at end of period

 

$

 

($3)




8




The following tables summarize the activity for the three months ended March 31, 2011 and the three months ended March 31, 2010,  in the accounts affected by the estimated provisions described below ($ amounts in thousands):


 

 

Three Months Ended March 31, 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)

 

($58,761)

 

$ -

 

$59,828

 

($18,415)

Rebates and incentive programs

 

(23,273)

 

(26,257)

 

660

 

24,916

 

(23,954)

Returns

 

(48,928)

 

(7,094)

 

265

 

4,341

 

(51,416)

Cash discounts and other

 

(16,606)

 

(25,274)

 

(357)

 

24,976

 

(17,261)

                  Total

 

($108,289)

 

($117,386)

 

$568

 

$114,061

 

($111,046)

 

 

 

 

 

 

 

 

 

 

 

Accrued liabilities (2)

 

($32,169)

 

($14,587)

 

$416

 

$15,969

 

($30,371)



 

 

Three Months Ended March 31, 2010

Accounts receivable reserves  

 

Beginning balance

 

Provision recorded for current period sales

 

(Provision) reversal recorded for prior period sales

 

Credits processed

 

Ending balance

Chargebacks

 

($16,111)

 

($47,385)

 

($77)

(1)

$49,233

 

($14,340)

Rebates and incentive programs

 

(39,938)

 

(33,117)

 

(1,196)

(3)

39,788

 

(34,463)

Returns

 

(39,063)

 

(4,945)

 

508 

 

2,615

 

(40,885)

Cash discounts and other

 

(19,160)

 

(15,446)

 

(658)

 

20,202

 

(15,062)

                  Total

 

($114,272)

 

($100,893)

 

($1,423)

 

$111,838

 

($104,750)

 

 

 

 

 

 

 

 

 

 

 

Accrued liabilities (2)

 

($24,713)

 

($11,395)

 

($845)

 

$4,302

 

($32,651)


(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)

During the first quarter of 2010, the Company settled a dispute with a major customer and as a result recorded an additional reserve of $1,300 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 60% of our net product sales were derived from the wholesale distribution channel for the three months ended March 31, 2011 and 53% for the three months ended March 31, 2010.  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



9



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 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 amounts in our allowance and accrual estimates on a



10



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, and amlodipine and benazepril HCL.  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.  


Strativa launched OravigTM (miconazole) buccal tablets in the third quarter of 2010 and launched Zuplenz® (ondansetron) oral soluble film in the fourth quarter of 2010.  OravigTM is supplied to us by BioAlliance and Zuplenz® is supplied to us by MonoSol.  In connection with the launches, our direct customers ordered, and we shipped, OravigTM and Zuplenz® units at a level commensurate with initial forecasted demand for the product.  Due to our relatively limited history in the branded pharmaceutical marketplace, it is impractical to predict with reasonable certainty the rate of OravigTM’s and Zuplenz®’s prescription demand uptake and ultimate acceptance in the marketplace.  Therefore, during the initial launch phase of OravigTM and Zuplenz®, we recognize revenue and all associated cost of sales as the product is prescribed to patients based on an analysis of third party market prescription data, third party wholesaler inventory data, order refill rates, and all substantive quantitative and qualitative data available to us at the time.  Accordingly, for the three month period ended March 31, 2011, we have recognized $749 thousand of revenues for OravigTM and $221 thousand of revenues for Zuplenz® and deferred revenues of $833 thousand for OravigTM and deferred revenues of $545 thousand for Zuplenz®, related to product that has been shipped to customers but not yet prescribed to patients.  Deferred revenue is included in accrued expenses and other current liabilities in the accompanying condensed consolidated balance sheet as of March 31, 2011.  We will modify our revenue recognition for OravigTM and Zuplenz® at the time that we have sufficient data and history to reliably estimate trade inventory levels in relation to forward looking demand.  


Major Customers – Gross Accounts Receivable


 

 

March 31,

 

December 31,

 

 

2011

 

2010

McKesson Corporation

 

26%

 

25%

AmerisourceBergen Corporation

 

17%

 

12%

Cardinal Health, Inc.

 

17%

 

21%

CVS Caremark

 

13%

 

14%

Other customers

 

27%

 

28%

Total gross accounts receivable

 

100%

 

100%


Note 6 - Inventories:

($ amounts in thousands)


 

 

March 31,

 

December 31,

 

 

2011

 

2010

Raw materials and supplies

 

$25,191

 

$20,445

Work-in-process

 

6,661

 

4,498

Finished goods

 

37,828

 

47,637

 

 

$69,680

 

$72,580


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

 

 

Three months ended

 

 

March 31,

 

March 31,

 

 

2011

 

2010

Inventory write-offs

 

$506

 

$1,732


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 their review in an efficient and timely manner and management is reasonably certain that all regulatory



11



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.  

Strativa also capitalizes inventory costs associated with in-licensed branded products subsequent to FDA approval but prior to product launch based on management’s judgment of probable future commercial use and net realizable value.  We believe that numerous factors must be considered in determining probable future commercial use and net realizable value including, but not limited to, Strativa’s limited number of historical product launches, as well as the ability of third party partners to successfully manufacture commercial quantities of product.  Strativa could be required to expense previously capitalized costs related to pre-launch inventory upon a change in such judgment, due to a delay in commercialization, product expiration dates, projected sales volume, estimated selling price or other potential factors.  

As of March 31, 2011, we had approximately $3,029 thousand in inventories related to products that were not yet available to be sold.  


The amounts in the table below are also included in the total inventory balances presented above.

Pre-Launch Inventories

($ amounts in thousands)


 

 

March 31,

 

December 31,

 

 

2011

 

2010

Raw materials and supplies

 

$2,336

 

$3,578

Work-in-process

 

494

 

673

Finished goods

 

199

 

3,207

 

 

$3,029

 

$7,458


Pre-launch inventories at December 31, 2010 were mainly comprised of in-house developed generic products and in-licensed FDA approved brand products.  Since that time, we have decreased the quantity of that inventory due to first quarter product launches.  There were no write-offs of pre-launch inventories, net of partner allocation, for the quarters ended March 31, 2011 and March 31, 2010.


Note 7 – Property, Plant and Equipment, net:

($ amounts in thousands)


 

 

March 31,

 

December 31,

 

 

2011

 

2010

Land

 

$1,882

 

$1,882

Buildings

 

27,989

 

27,930

Machinery and equipment

 

53,430

 

52,032

Office equipment, furniture and fixtures

 

5,752

 

5,752

Computer software and hardware

 

46,469

 

46,065

Leasehold improvements

 

12,137

 

12,137

Construction in progress

 

3,851

 

2,905

 

 

151,511

 

148,703

Accumulated depreciation and amortization

 

(79,734)

 

(76,723)

 

 

$71,777

 

$71,980


Depreciation and amortization expense related to property, plant and equipment

 

 

Three months ended

 

 

March 31,

 

March 31,

 

 

2011

 

2010

Depreciation and amortization expense

 

$3,137

 

$3,248





12



Note 8 - Intangible Assets, net:

($ amounts in thousands)

 

 

March 31,

 

December 31,

 

 

2011

 

2010

QOL Medical, LLC Asset Purchase Agreement, net of accumulated amortization of $9,120
       and $7,980

 

$45,601

 

$46,741

BioAlliance Licensing Agreement, net of accumulated amortization of $979 and $559

 

19,021

 

19,441

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

 

15,000

 

15,000

MonoSol Rx Licensing Agreement, net of accumulated amortization of $225 and $125

 

5,775

 

5,875

Trademark licensed from Bristol-Myers Squibb Company, net of accumulated
        amortization of $7,776 and $7,433

 

2,224

 

2,567

Genpharm, Inc. Distribution Agreement, net of accumulated amortization of $9,207
       and $9,026

 

1,626

 

1,807

SVC Pharma LP License and Distribution Agreement, net of accumulated amortization
        of $2,595 and $2,525

 

1,089

 

1,159

MDRNA, Inc. Asset Purchase Agreement, net of accumulated amortization of $1,027
       and $770

 

1,073

 

1,330

Spectrum Development and Marketing Agreement, net of accumulated amortization of
        $24,470 and $24,254

 

530

 

746

Other intangible assets, net of accumulated amortization of $6,325 and $5,947

 

423

 

801

 

 

$92,362

 

$95,467


 

   We recorded amortization expense related to intangible assets of $3,105 thousand for the three months ended March 31, 2011 and $4,250 thousand for the three months ended March 31, 2010.  The majority of this amortization expense is included in cost of goods sold.

In July 2010, the FDA approved Zuplenz®, an oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.  In June 2008, Strativa and MonoSol Rx entered into an exclusive licensing agreement under which Strativa acquired the U.S. commercialization rights to Zuplenz®. Under the terms of an amended agreement, the FDA approval triggered Strativa's payments to MonoSol Rx of a $4,000 thousand approval milestone and a $2,000 thousand pre-launch milestone.  Strativa began to commercialize Zuplenz®, which is supplied by MonoSol, during the fourth quarter of 2010.  Amortization expense of the related intangible asset commenced when the product was launched in the fourth quarter of 2010.


In May 2010, Par entered into a licensing agreement with Glenmark Generics to market ezetimibe 10 mg tablets, the generic version of Merck & Co. Inc.’s Zetia®, in the U.S.  Glenmark believes it is the first to file an ANDA containing a paragraph IV certification for the product, which would potentially provide 180 days of marketing exclusivity.  On April 24, 2009, Glenmark was granted tentative approval for its product by the FDA.  Under the terms of the licensing and supply agreement, we made a $15,000 thousand payment to Glenmark for exclusive rights to market, sell and distribute the product in the U.S.  The companies will participate in a profit sharing arrangement based on any future sales of the product.  Glenmark will supply the product subject to FDA approval.  The product has a contractual launch date of no later than December 2016.  Under defined conditions, the product could be launched earlier than December 2016.  Amortization expense of the related intangible asset will commence when the product is launched.  


In April 2010, the FDA approved OravigTM, an antifungal therapy for the treatment of oropharyngeal candidiasis, an opportunistic infection commonly found in immunocompromised patients, including those with HIV and cancer.  Under the terms of Strativa’s exclusive U.S. license agreement with BioAlliance, we paid BioAlliance $20,000 thousand in the second quarter of 2010 as a result of the FDA approval.  Strativa began to commercialize OravigTM, which will be supplied by BioAlliance, during the third quarter of 2010.  In addition to paying BioAlliance royalties on net sales, BioAlliance may also be eligible to receive additional milestone payments if commercial sales achieve specified sales targets.


In January 2010, we reached a settlement with a third party of two litigations related to the enforcement of our patent rights and acquired intellectual property related to a product that was the subject of the litigations.  We paid $3,500 thousand in settlement of the two litigations and $500 thousand to acquire the intellectual property.  The $3,500 thousand was recorded as expense in 2009 as a change in estimate and the $500 thousand was recorded as an intangible asset in first quarter of 2010 and included in “Other intangible assets” above.  






13



Estimated Amortization Expense for Existing Intangible Assets at March 31, 2011

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 March 31, 2011.

($ amounts in thousands)

 

 

Estimated

 

 

Amortization

 

 

Expense

2011 (remainder)

 

$8,565

2012

 

9,154

2013

 

7,477

2014

 

6,783

2015

 

6,783

2016 and thereafter

 

53,600

 

 

$92,362


As of March 31, 2011, we did not note any business circumstances or events that would indicate any of our net intangible assets were impaired.  


Note 9 - Income Taxes:

 

 

Three months ended

 

 

March 31,

 

March 31,

($ in thousands)

 

2011

 

2010

(Benefit) provision for income taxes

 

($29,446)

 

$16,330

Effective tax rate

 

21%

 

38%



The effective tax rate for the three months ended March 31, 2011 is reduced by our estimate of the portion of legal settlements and loss contingencies provided for in the quarter which may not be tax deductible and by non-deductibility of our portion of healthcare reforms pharmaceutical manufacturer fee.  For purpose of determining our tax benefit for the three months ended March 31, 2011, certain Average Wholesale Prices litigation matters were treated as a discreet event under the provisions of ASC 740, Income Taxes.  Current deferred income tax assets at March 31, 2011 and December 31, 2010 consisted of temporary differences primarily related to accounts receivable reserves.  Non-current deferred income tax assets at March 31, 2011 and December 31, 2010 consisted of timing differences primarily related to intangible assets, stock options, severance, and depreciation.

The IRS is currently examining our 2007 and 2008 federal income tax returns.  Periods prior to 2004 are no longer subject to IRS audit.  We are currently under audit in two state jurisdictions for the years 2003-2008.  In most other state jurisdictions, we are no longer subject to examination by tax authorities for years prior to 2006.

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 March 31, 2011, we had $43.3 million included in “Long-term liabilities” on the condensed consolidated balance sheet that represented unrecognized tax benefits, interest and penalties based on evaluation of tax positions and concession on tax issues challenged by the IRS.  We believe that it is reasonably possible that approximately $22.0 million of our current unrecognized tax positions may be recognized within the next twelve months as a result of settlements or a lapse of the statute of limitations.  


Note 10 - Unsecured Credit Facility:

Effective October 1, 2010, we entered into a $75 million unsecured credit facility with JPMorgan Chase Bank, N.A., as Administrative Agent and U.S. Bank National Association as Syndication Agent.  The credit facility has an accordion feature pursuant to which we can increase the amount available to be borrowed by up to an additional $25 million under certain circumstances.  The credit facility expires on October 1, 2013.  We had no borrowings under the credit facility as of March 31, 2011 or December 31, 2010.  The interest rates payable under the credit facility will be based on defined published rates plus an applicable margin.   We must pay a commitment fee based on the unused portion of the revolving credit facility.  The credit facility 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 due, breach of covenants, breach of representations and warranties, insolvency proceedings, certain judgments and attachments and any change of control.   The credit facility agreement also contains various customary covenants that, in certain instances, restrict our ability to: (i) incur indebtedness; (ii) create liens on assets;



14



(iii) engage in mergers or consolidations; (iv) engage in dispositions of assets; (v) make investments, loans, guarantees or advances; (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 facility agreement requires us to maintain the following financial covenants: (a) a maximum leverage ratio, and (b) a minimum fixed charge coverage ratio.   All obligations under the credit facility are guaranteed by our material domestic subsidiaries.  We incurred approximately $150 thousand in expenses associated with the credit facility during the three-month period ended March 31, 2011.   



Note 11 - Changes in Stockholders’ Equity:

Changes in our Common Stock, Additional Paid-In Capital and Accumulated Other Comprehensive Gain/(Loss) accounts during the three-month period ended March 31, 2011 were as follows (share amounts and $ amounts in thousands):

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

Additional

 

Other

 

 

Common Stock

 

Paid-In

 

Comprehensive

 

 

Shares

 

Amount

 

Capital

 

Gain/(Loss)

Balance, December 31, 2010

 

38,873 

 

$

389 

 

$

373,764 

 

$

137 

Unrealized loss on available for sale securities, net of tax

 

 

 

 

(54)

Exercise of stock options

 

347 

 

 

5,033 

 

Net excess tax benefit from share-based compensation

 

 

 

5,717 

 

Resolution of tax contingencies

 

 

 

 

Issuance of common stock under the Employee Stock
    Purchase Program

 

 

 

84 

 

Forfeitures of restricted stock

 

(30)

 

 

 

Issuances of restricted stock

 

159 

 

(2)

 

 

Cash settlement of share-based compensation

 

 

 

(4,133)

 

 

Compensatory arrangements (a)

 

 

 

3,167 

 

Balance, March 31, 2011

 

39,349 

 

$

391 

 

$

383,633 

 

$

83 


(a)

Share-based compensation expense includes equity-settled awards only.


Comprehensive (Loss) Income

 

Three months ended

($ amounts in thousands)

 

March 31,

 

March 31,

 

 

2011

 

2010

 

 

 

 

 

Net (loss) income

 

($108,971)

 

$

26,298 

Other comprehensive (loss) income:

 

 

 

 

Unrealized loss on marketable securities, net of tax

 

(54)

 

(86)

Add: reclassification adjustment for net losses included
    in net income, net of tax

 

-

 

Comprehensive (loss) income

 

($109,025)

 

$

26,212 

 

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 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 or the first quarter of 2011.  The authorized amount remaining for stock repurchases under the repurchase program was $43.6 million, as of March 31, 2011.  The repurchase program has no expiration date.  




15



Note 12 - 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

 

 

March 31,

 

March 31,

 

 

2011

 

2010

 

 

 

 

 

(Loss) income from continuing operations

 

($108,844)

 

$

26,426 

 

 

 

 

 

Provision for income taxes from discontinued operations

 

127 

 

128 

Loss from discontinued operations

 

(127)

 

(128)

Net (loss) income

 

($108,971)

 

$

26,298 

 

 

 

 

 

Basic:

 

 

 

 

Weighted average number of common shares outstanding

 

35,500 

 

33,929 

 

 

 

 

 

(Loss) income from continuing operations

 

($3.07)

 

$

0.78 

Loss from discontinued operations

 

(0.00)

 

(0.00)

Net (loss) income per share of common stock

 

($3.07)

 

$

0.78 

 

 

 

 

 

Assuming dilution:

 

 

 

 

Weighted average number of common shares outstanding

 

35,500 

 

33,929 

Effect of dilutive securities

 

 

1,141 

Weighted average number of common and common
   equivalent shares outstanding

 

35,500 

 

35,070 

 

 

 

 

 

(Loss) income from continuing operations

 

($3.07)

 

$

0.75 

Loss from discontinued operations

 

(0.00)

 

(0.00)

Net (loss) income per share of common stock

 

($3.07)

 

$

0.75 

 

Outstanding options of 612 thousand as of March 31, 2011 and 2,114 thousand as of March 31, 2010 were not included in the computation of diluted earnings per share because their exercise prices were greater than the average market price of the common stock during the respective periods and their inclusion would, therefore, have been anti-dilutive.  Since we had a net loss for the three months ended March 31, 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 902 thousand on weighted average number of common shares outstanding for the three months ended March 31, 2011.  Similarly, outstanding warrants issued in conjunction with the acquisition of Kali in June 2004 were not included in the computation of diluted earnings per share for any period presented.  The warrants related to the Kali acquisition are exercisable for an aggregate of 150 thousand shares of common stock at an exercise price of $47.00 per share and expire in June 2011.


Note 13 - 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.   


As of March 31, 2011, there were approximately 4.6 million shares of common stock available for future stock option grants.  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 March 31, 2011, approximately 0.3 million shares remain available under such plans for restricted stock and restricted stock unit grants.




16



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

 

 

March 31,

 

March 31,

 

 

2011

 

2010

Risk-free interest rate

 

2.2%

 

3.1%

Expected life (in years)

 

5.2

 

6.3

Expected volatility

 

44.6%

 

45.2%

Dividend

 

0%

 

0%


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.  Through 2010, we had used the “simplified method” for “plain vanilla” options described in FASB ASC 718-10-S99 Compensation – Stock Compensation – SEC Materials.  The “simplified method” calculation is the average of the vesting term plus the original contractual term divided by two.  In 2011, we modified our expected life weighted average assumption 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 three-month periods ended March 31, 2011 and March 31, 2010.


 

 

Three months ended

 

 

March 31,

 

March 31,

 

 

2011

 

2010

Weighted average per share fair value of
    options granted

 

$15.42

 

$13.35



Set forth below is the impact on Par’s results of operations of recording share-based compensation from its stock options for the three-month periods ended March 31, 2011 and March 31, 2010 ($ amounts in thousands):


 

 

Three months ended

 

 

March 31,

 

March 31,

 

 

2011

 

2010

Cost of goods sold

 

$149

 

$138

Selling, general and administrative

 

1,343

 

1,246

Total, pre-tax

 

$1,492

 

$1,384

Tax effect of share-based compensation

 

(567)

 

(526)

Total, net of tax

 

$925

 

$858

 



17



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, 2010

 

3,132

 

$26.23

 

 

 

 

   Granted

 

222

 

36.45

 

 

 

 

   Exercised

 

(347)

 

14.43

 

 

 

 

   Forfeited

 

(192)

 

24.31

 

 

 

 

Balance at March 31, 2011

 

2,815

 

$28.63

 

6.0

 

$21,244

Exercisable at March 31, 2011

 

1,728

 

$33.26

 

4.5

 

$9,399

Vested and expected to vest at March 31, 2011

 

2,760

 

$28.77

 

5.6

 

$20,666


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

 

 

Three months ended

 

 

March 31,

 

March 31,

 

 

2011

 

2010

Total fair value of shares vested

 

$3,755

 

$2,508


As of March 31, 2011, the total compensation cost related to all non-vested stock options granted to employees but not yet recognized was approximately $9.0 million, net of estimated forfeitures.  This cost will be amortized on a straight-line basis over the remaining weighted average vesting period of 2.3 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 three-month periods ended March 31, 2011 and March 31, 2010 was as follows ($ amounts in thousands):


 

 

Three months ended

 

 

March 31,

 

March 31,

 

 

2011

 

2010

Cost of goods sold

 

$

168 

 

$

173 

Selling, general and administrative

 

1,507 

 

1,552 

Total, pre-tax

 

$

1,675 

 

$

1,725 

Tax effect of stock-based compensation

 

(637)

 

(656)

Total, net of tax

 

$

1,038 

 

$

1,069 

 

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, 2010

 

496 

 

$

19.52

 

 

   Granted

 

62 

 

36.54

 

 

   Vested

 

(177)

 

21.01

 

 

   Forfeited

 

(30)

 

18.84

 

 

Non-vested balance at March 31, 2011

 

351 

 

$

21.85

 

$10,899

 



18



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

 

 

Shares

 

Weighted Average Grant Price

 

Aggregate Intrinsic Value

Non-vested restricted stock unit balance at
   December 31, 2010

 

23 

 

$27.68

 

 

   Granted

 

68 

 

36.58

 

 

   Vested

 

(22)

 

28.05

 

 

   Forfeited

 

 

-

 

 

Non-vested restricted stock unit balance at
   March 31, 2011

 

69 

 

$36.16

 

$2,192

Vested awards not issued

 

160 

 

$21.93

 

$4,967

Total restricted stock unit balance at
   March 31, 2011

 

229 

 

$26.29

 

$7,159

 

 As of March 31, 2011, the total compensation cost related to all non-vested restricted stock and restricted stock units granted to employees but not yet recognized was approximately $8.5 million, net of estimated forfeitures; this cost will be amortized on a straight-line basis over the remaining weighted average vesting period of approximately 2.5 years.  


Restricted Stock Grants With Market Vesting Conditions

In 2008, we issued restricted stock grants with market vesting conditions.  The vesting of restricted stock grants issued to certain of our employees was contingent upon multiple market conditions that were factored into the fair value of the restricted stock at grant date with cliff vesting after three years if the market conditions had been met.  Vesting was contingent upon applicable continued employment condition and the Total Stockholder Return (“TSR”) on our common stock relative to the Company’s stock price at the beginning of the three-year vesting period as compared to the TSR of a defined peer group of approximately 12 companies, and the TSR of the Standard and Poor’s 400 Mid Cap Index (“S&P 400”) over the three-year measurement period.  The measurement period ended on December 31, 2010.  The Company achieved the maximum level of performance under the program because the Company’s TSR was greater than the 75th percentile TSR of the peer group and the Company’s TSR was greater than the median of the S&P 400 during the three year measurement period.  Approximately 454 thousand shares of common stock were earned as of the vesting date, January 11, 2011.  Approximately 65 thousand shares were issued in 2008 by operation of the provisions of employment contracts for three senior executives whose employment with us was terminated.  Approximately 339 thousand shares of common stock were distributed in January 2011.  Approximately 115 thousand shares were cash settled upon the discretion of the Compensation Committee of the Board of Directors for approximately $4.1 million (pre-tax) in January 2011.  In all circumstances, restricted stock granted did not entitle the holder the right, or obligate the Company, to settle the restricted stock in cash.  


At the grant date, the effect of the market conditions on the restricted stock issued to certain employees was reflected in their fair value.  The restricted stock grants with market conditions were valued using a Monte Carlo simulation.  The Monte Carlo simulation estimates the fair value based on the expected term of the award, risk-free interest rate, expected dividends, and the expected volatility for the Company, our peer group, and the S&P 400.  The expected term was estimated based on the vesting period of the awards (3 years), the risk-free interest rate was based on the yield on the Federal Reserve treasury rate with a maturity matching the vesting period (2.6%).  The expected dividends were assumed to be zero.  Volatility was based on historical volatility over the expected term (40%).  Restricted stock that included multiple market conditions had a grant date fair value per restricted share of $24.78.


        The following table summarizes the components of our stock-based compensation related to our restricted stock grants with market conditions recognized in our financial statements for the three-month periods ended March 31, 2011 and March 31, 2010 ($ amounts in thousands):

 

 

Three months ended

 

 

March 31,

 

March 31,

 

 

2011

 

2010

Cost of goods sold

 

$ -

 

$

51 

Selling, general and administrative

 

 -

 

458 

Total, pre-tax

 

$ -

 

$

509 

Tax effect of stock-based compensation

 

 -

 

(193)

Total, net of tax

 

$ -

 

$

316 

 

19


The following is a summary of our restricted stock grants with market condition vesting (shares and aggregate intrinsic value in thousands):

 

 

Shares

 

Weighted Average Grant Date Fair Value Per Share

 

Aggregate Intrinsic Value

Non-vested balance at December 31, 2010

 

242 

 

$24.78

 

 

   Granted

 

97 

 

36.54

 

 

   Vested

 

(339)

 

25.95

 

 

   Forfeited

 

 

-

 

 

Non-vested balance at March 31, 2011

 

$

 

$ -

 

$ -

 

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 (marked 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 three-month periods ended March 31, 2011 and March 31, 2010 was as follows ($ amounts in thousands):


 

 

Three months ended

 

 

March 31,

 

March 31,

 

 

2011

 

2010

Cost of goods sold

 

$

75 

 

$

10 

Selling, general and administrative

 

678 

 

91 

Total, pre-tax

 

$

753 

 

$

101 

Tax effect of stock-based compensation

 

(286)

 

(38)

Total, net of tax

 

$

467 

 

$

63 

 

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, 2010

 

72 

 

$

28.13

 

 

   Granted

 

104 

 

35.60

 

 

   Vested

 

(17)

 

27.71

 

 

   Forfeited

 

(2)

 

27.71

 

 

Awards outstanding at March 31, 2011

 

157 

 

$

33.12

 

$4,885

 

As of March 31, 2011, unrecognized compensation costs related to non-vested cash-settled restricted stock units was approximately $3.8 million, net of estimated forfeitures.  This cost will be amortized on a straight-line basis over the remaining vesting period of approximately 3.5 years.


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.  Employees purchased three thousand shares during the three-month period ended March 31, 2011 and three thousand shares during the three-month period ended March 31, 2010.



20




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 (marked 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.  Share-based compensation expense for these CAGR awards will be recognized ratably over the three year service period.  Our CAGR was below 4% from January 1, 2011.  

Mr. LePore will not be eligible to participate in our annual long-term incentive programs during the three year term of his new employment agreement.  Instead, 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 ($36.54) of our common stock on the date of grant.


Note 14 - 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 adverse 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 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.  We and Messrs. O’Connor and Tarriff have answered the Amended complaint and intend to vigorously defend the consolidated class action. Plaintiffs have filed a motion for class certification which we and the other defendants intend to oppose.


Patent Related Matters


On April 28, 2006, CIMA Labs, Inc. (“CIMA”) and Schwarz Pharma, Inc. (“Schwarz Pharma”) 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.  All 40 claims in the ’981 patent were rejected in two non-final office actions in a reexamination proceeding at the United States Patent and Trademark Office (“USPTO”) on February 24, 2006 and on February 24, 2007.  The ‘392 patent is also the subject of a reexamination proceeding.  On July 10, 2008, the USPTO rejected with finality 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



21



in the ‘981 patent.  On November 25, 2009, plaintiffs requested a rehearing before the USPTO Board of Appeals regarding the ’981 patent.  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.   We intend to vigorously defend this lawsuit and pursue our counterclaims.

We entered into a licensing agreement with developer Paddock Laboratories, Inc. (“Paddock”) to market testosterone 1% gel, a generic version of Unimed Pharmaceuticals, Inc.’s (“Unimed”) 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 (the “Paddock litigation”).  On September 13, 2006, we acquired from Paddock all rights to the ANDA for the testosterone 1% gel, and the Paddock litigation was resolved by a settlement and license agreement that terminates 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 court-approved settlement in 2006 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 Par’s motion to transfer the FTC lawsuit and the private plaintiffs’ complaints to the U.S. District Court for the Northern District of Georgia.  On July 20, 2009, we filed a motion to dismiss the FTC’s case and on September 1, 2009, we filed a motion to dismiss the private plaintiffs’ cases in the U.S. District Court for the Northern District of Georgia, and on February 23, 2010, the 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 March 11, 2011, the Court of Appeals scheduled oral argument in the appellate case for May 13, 2011.  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 July 6, 2007, Sanofi-Aventis and Debiopharm, S.A. filed a lawsuit against us and our development partner, MN Pharmaceuticals ("MN"), in the U.S. District Court for the District of New Jersey.  The complaint alleges infringement of U.S. Patent Nos. 5,338,874 (the “’874 patent”) and 5,716,988 (the “’988 patent”) after we and MN submitted a Paragraph IV certification to the FDA for approval of 50 mg/10 ml, 100 mg/20 ml, and 200 mg/40 ml oxaliplatin by injection.  On January 14, 2008, following MN's amendment of its ANDA to include oxaliplatin injectable 5 mg/ml, 40 ml vial, Sanofi-Aventis filed a complaint asserting infringement of the '874 and the '988 patents.  MN and we filed our Answer and Counterclaim on February 20, 2008.  On June 18, 2009, the District Court granted summary judgment of non-infringement to several defendants, including us, on the ’874 patent, but to date has not rendered a summary judgment decision regarding the ’988 patent.  On September 10, 2009, the U.S. Court of Appeals for the Federal Circuit reversed the District Court and remanded the case for further proceedings.  On September 24, 2009, Sanofi-Aventis filed a motion for preliminary injunction against defendants who entered the market following the District Court’s summary judgment ruling.  On November 19, 2009, the District Court dismissed all pending motions for summary judgment with possibility of the motions being renewed upon letter request to the Court.  On April 14, 2010, the District Court entered a consent judgment and order agreed to by us, MN, and the plaintiffs, which agreement settled the pending litigation.  In view of this agreement, MN and we will enter the market with generic Eloxatin on August 9, 2012, or earlier in certain circumstances.   

 On October 1, 2007, Elan Corporation, PLC (“Elan”) filed a lawsuit against us and our development partners, IntelliPharmaCeutics Corp. and IntelliPharmaCeutics Ltd. ("IPC"), in the U.S. District Court for the District of Delaware.  On October 5, 2007, Celgene Corporation (“Celgene”) 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 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 mg, 10 mg, 15 mg, and 20 mg dexmethylphenidate hydrochloride extended release capsules.  The complaint in the New Jersey case alleged 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 IPC and we submitted a Paragraph IV certification to the FDA for approval of 5 mg, 10 mg, 15 mg, and 20 mg dexmethylphenidate extended release capsules.  On March 5, 2010 and March 15, 2010, the U.S. District Courts for the Districts of New Jersey and Delaware, respectively, entered stays of the litigation between plaintiffs and us and IPC in view of settlement agreements reached by the parties.  The settlement agreement terms are confidential.

On March 25, 2011, Elan Corporation, PLC (“Elan”) filed a lawsuit against us and our development partners, IntelliPharmaceutics Corp. and IntelliPharmaCeutics Ltd. (“IPC”) in the U.S. District Court for the District of Delaware, and Celgene Corporation (“Celgene”) 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 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 30 mg dexmethylphenidate hydrochloride extended release capsules.  The complaint in the New Jersey case alleged 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 IPC and we submitted a Paragraph IV certification to the FDA for approval of 30 mg dexmethylphenidate extended release capsules.  We intend to vigorously defend and expeditiously resolve these lawsuits.

On September 13, 2007, Santarus, Inc. (“Santarus”) 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.



22



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 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 filed our notice of appeal to the Court of Appeals for the Federal Circuit, appealing the District Court’s decision. On December 15, 2010, the District Court granted our motion to dismiss a case brought by AstraZeneca asserting we infringed its rosuvastatin process patents.  We intend to defend all of these actions vigorously.

On November 14, 2008, Pozen, Inc. (“Pozen”) 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 by the Court, 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 through October 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.  We are awaiting the Court’s final decision.     

On April 29, 2009, Pronova BioPharma ASA (“Pronova”) 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.  On June 8, 2010, a new patent, U.S. 7,732,488, which was later listed in the Orange Book, was issued to Pronova.  A second case, involving the claims of the ’488 patent and two other patents not listed in the Orange Book and asserted by the plaintiffs, has a trial date set for January 3, 2012.  A bench trial  in the first case  took place from March 29, 2011 to April 7, 2011.  We intend to continue to defend this action vigorously and pursue our defenses and counterclaims against Pronova.   

On July 1, 2009, Alcon Research Ltd. (“Alcon”) 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. 5,510,383; 5,631,287; 5,849,792; 5,889,052; 6,011,062; 6,503,497; and 6,849,253 because we submitted a Paragraph IV certification to the FDA for approval of 0.004% travoprost ophthalmic solutions and 0.004% travoprost ophthalmic solutions (preserved).  We filed an Answer on August 21, 2009.  The Court rescheduled the end of fact discovery for December 31, 2010 and the end of expert discovery for May 9, 2011.  Trial has yet to be rescheduled.  The Court has set July 1, 2011 as the due date for the pre-trial order.  We intend to defend this action vigorously and pursue our defenses and counterclaims against Alcon.

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.  We filed an answer and counterclaims on August 25, 2010, and an initial Rule 16 conference was held on November 10, 2010.  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.  We intend to appeal that decision.  The Court has presently scheduled the close of expert discovery for July 5, 2011, and the close of fact discovery for August 5, 2011.  A Markman hearing has been scheduled for August 15, 2011.  We intend to defend this action vigorously and pursue all of our defenses and counterclaims against Warner Chilcott and Medeva Pharma.

On September 20, 2010, Schering-Plough HealthCare Products (“Schering-Plough”), Santarus, Inc. (“Santarus”), 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.




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On September 22, 2010, Biovail Laboratories filed a lawsuit against us in the U.S. District Court for the Southern District of New York.  The complaint alleges infringement of U.S. Patent Nos. 7,569,610; 7,572,935; 7,649,019; 7,553,992; 7,671,094; 7,241,805; 7,645,802; 7,662,407; and 7,645,901 because we submitted an ANDA with a Paragraph IV certification to the FDA for approval of extended-release tablets of 174 mg and 348 mg bupropion hydrobromide.  On November 10, 2010, we filed our answer to the complaint.  On November 22, 2010, the Court set a March 31, 2011 deadline for all discovery.  On March 7, 2011, the Court reset the deadline for all discovery to May 18, 2011.   We intend to defend this action vigorously.

On October 4, 2010, UCB Manufacturing, Inc. (“UCB”) 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.  We intend to vigorously defend the lawsuit and any appeal by plaintiffs, should one be filed.

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.  We intend to defend this action vigorously.

On March 23, 2011, we filed a declaratory judgment action against UCB, Inc. and UCB Pharma SA (“UCB”) in the U.S. District Court for the Eastern District of Pennsylvania requesting that the Court render a judgment of invalidity and/or non-infringement of U.S. Patent Nos. 7,858,122 and 7,863,316 in view of our eventual marketing of levetiracetam extended release oral tablets, 500 mg and 750 mg pursuant to our filed ANDA that was accompanied by a Paragraph IV certification.  We intend to vigorously prosecute this action against UCB.

Industry Related Matters


Beginning in September 2003, we, along with numerous other pharmaceutical companies, have been named as a defendant in actions brought by a number of state Attorneys General and municipal bodies within the state of New York, as well as a federal qui tam action brought on behalf of the United States by the pharmacy Ven-A-Care of the Florida Keys, Inc. ("Ven-A-Care") 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.  To date, we have been named as a defendant in substantially similar civil law suits filed by the Attorneys General of Alabama, Alaska, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Mississippi, Oklahoma, South Carolina, Texas and Utah, and also by the city of New York, 46 counties across New York State and Ven-A-Care.  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. Several of these cases have been transferred to the AWP multi-district litigation proceedings pending in the U.S. District Court for the District of Massachusetts for pre-trial proceedings.  The case brought by the state of Mississippi will be litigated in the Chancery Court of Rankin County, Mississippi.  The other cases will likely be litigated in the state or federal courts in which they were filed.  In the Utah suit, the time for responding to the complaint has not yet elapsed.   The Hawaii suit was settled on August 25, 2010 for $2,250 thousand.   The Massachusetts suit was settled on December 17, 2010 for $500 thousand.  The Alabama suit was settled on January 5, 2011 for $2,500 thousand.  The Idaho suit was settled on March 25, 2011 for $1,700 thousand.  On April 27, 2011, we reached a settlement in principle to resolve claims brought by Ven-A-Care, Texas, and Florida, under federal and state law, as well as Alaska, South Carolina, and Kentucky under state law for $154,000 thousand. Upon execution of definitive settlement documents and government and court approvals, the settlement will resolve a lawsuit relating to federal contributions to state Medicaid programs in 49 states (excluding Illinois), and claims of Texas, Florida, Alaska, South Carolina and Kentucky relating to their Medicaid programs. The settlement in principal will eliminate the majority of the alleged damages asserted against us in the various drug pricing litigations and removes all trials that had been scheduled to date. The remaining matters have yet to be scheduled for trial.  We have accrued a $197,100 thousand reserve under the caption “Accrued legal settlements” on our condensed consolidated balance sheet as of March 31, 2011, in connection with the April 27, 2011, settlement in principal and the remaining AWP actions.  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.    


In the civil lawsuit brought by the City of New York and certain counties within the State of New York, the U.S. District Court for the District of Massachusetts entered an order on January 27, 2010, denying the defendants’ motion for summary judgment on plaintiffs’ claims related to the federal upper limit ("FUL") and granting the plaintiffs’ motion for partial

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summary judgment on FUL-based claims under New York Social Services Law § 145-b for nine drugs manufactured by thirteen defendants, including us. The Court has reserved judgment regarding damages until after further briefing.  On February 8, 2010, we and certain defendants filed a motion to amend the order for certification for immediate appeal, which was opposed by the plaintiffs on February 22, 2010.

In addition, 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.  During the first quarter of 2011, we continued to engage the respective Attorneys General, the USOPM and the Department of Justice, led by the U.S. Attorneys in the Northern District of Illinois, in discussions concerning these allegations, and we will continue to cooperate if called upon to do so.

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 provided, or are in the process of providing, documents in response to this subpoena to the Department of Justice and will continue to cooperate with the Department of Justice in this inquiry if called upon to do so.

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 adverse 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.


Contingency

In March 2011, we reached a settlement related to the routine post-award contract review of our contract with the Department of Veterans Affairs for the periods 2004 to 2007 with the Office of Inspector General of the Department of Veterans Affairs.  The settlement amount is equal to the loss contingency of approximately $1.1 million, including interest, in accrued expenses and other current liabilities and payables due to distribution agreement partners accrued on our consolidated balance sheet as of December 31, 2010, related to this matter.  Refer to Note 5 - “Accounts Receivable” for more information.    

In December 2010, we submitted to the Texas Health and Human Services Commission (“Texas”) $6,540 thousand resulting from a procedural error relating to pharmacy reimbursement between 1999 and 2006.  This amount was never cashed by Texas.  The obligation related to this item is included with our April 27, 2011 settlement in principal in the associated AWP matter (described above).    


Note 15 – 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 2010 and 2009 we recorded tax amounts to discontinued operations for interest related to 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 16 - 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 President and 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

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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 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

 

 

March 31,

 

March 31,

 

 

2011

 

2010

Revenues:

 

 

 

 

   Par Pharmaceutical

 

$209,745

 

$272,039

   Strativa

 

23,207

 

19,893

Total revenues

 

$232,952

 

$291,932

 

 

 

 

 

Gross margin:

 

 

 

 

   Par Pharmaceutical

 

$92,559

 

$68,443

   Strativa

 

17,093

 

15,067

Total gross margin

 

$109,652

 

$83,510

 

 

 

 

 

Operating (loss) income:

 

 

 

 

   Par Pharmaceutical

 

($132,746)

 

$46,022

   Strativa

 

(5,817)

 

(2,686)

Total operating (loss) income

 

($138,563)

 

$43,336

   Interest income

 

423

 

328

   Interest expense

 

(150)

 

(908)

   (Benefit) provision for income taxes

 

(29,446)

 

16,330

(Loss) income from continuing operations

 

($108,844)

 

$26,426


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):

 

 

 

Three months ended

Product

 

March 31,

March 31,

 

 

2011

2010

     Par Pharmaceutical

 

 

 

Metoprolol succinate ER (Toprol-XL®)

 

$63,418

$183,291

Propafenone (Rythmol SR®)

 

22,039

-

Amlodipine and Benazepril HCI (Lotrel®)

 

18,171

-

Sumatriptan succinate injection (Imitrex®)

 

16,699

17,284

Chlorpheniramine/Hydrocodone (Tussionex®)

 

12,679

-

Dronabinol (Marinol®)

 

6,871

4,091

Tramadol ER (Ultracet ER®)

 

6,081

5,286

Clonidine TDS (Catapres TTS®)

 

5,806

18,461

Meclizine Hydrochloride (Antivert®)

 

4,875

10,154

Other (1)

 

45,217

32,318

Other product related revenues (2)

 

7,889

1,154

Total Par Pharmaceutical Revenues

 

$209,745

$272,039



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Three months ended

Product

 

March 31,

March 31,

 

 

2011

2010

 

 

 

 

     Strativa

 

 

 

Megace® ES

 

$14,085

$13,798

Nascobal® Nasal Spray

 

3,878

3,595

OravigTM

 

749

-

Zuplenz®

 

221

-

Other product related revenues (2)

 

4,274

2,500

Total Strativa Revenues

 

$23,207

$19,893

 

(1)

The further detailing of revenues of the other approximately 60 generic drugs is impracticable due to the low volume of revenues associated with each of these generic products.  No single product in the other category is in excess of 3% of total generic revenues for three-month periods ended March 31, 2011 or March 31, 2010.


(2)

Other product related revenues represents licensing and royalty related revenues from profit sharing agreements related to products such as doxycycline monohydrate, the generic version of Adoxa®, diazepam rectal gel, the generic version of Diastat®, and fenofibrate, the generic version of Tricor®.  Other product related revenues included in the Strativa segment related to a co-promotion arrangement with Solvay for Androgel® in 2010.   This co-promotion arrangement with Solvay was terminated in December 2010 for an associated $2 million payment.  During the three-month period ended March 31, 2011, Strativa earned $4.3 million of royalty income from its share of the proceeds from Optimer Pharmaceuticals’ sale of certain rights in fidaxomicin to a third party.  Under the terms of the 2007 termination agreement, we are also entitled to royalty payments on future sales of fidaxomicin.


During the three-month period ended March 31, 2010, we recognized a gain on the sale of product rights of $5,775 thousand, related to the sale of multiple ANDAs.


Note 17 - Research and Development Agreements:

In June 2008, through an exclusive licensing agreement with MonoSol Rx (“MonoSol”), Strativa acquired the U.S. commercialization rights to MonoSol’s oral soluble film formulation of ondansetron (Zuplenz®) for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.  In December 2009, the parties amended the agreement to modify the terms of future milestone and royalty payments and concurrently entered into another agreement noted below.  The amendment provided for a reduction in future payments, thus improving gross margins on future sales of Zuplenz®.  On July 2, 2010, the FDA approved Zuplenz®, which we offer in 4mg and 8mg dosage strengths.  We paid MonoSol a total of $6,000 thousand as a result of the FDA approval.  We launched Zuplenz® in October 2010.  MonoSol will supply the product and Strativa will pay MonoSol royalties on net sales of the product.  MonoSol will also be eligible to receive sales milestone payments if net sales reach certain threshold amounts in any given calendar year.   

In December 2009, concurrently with the amendment of the Zuplenz® agreement noted above, Strativa entered into another exclusive licensing agreement with MonoSol to acquire the U.S. commercialization rights to MonoSol’s oral soluble film formulation of up to three potential new products.  Under this agreement, we made a one-time payment of $6,500 thousand, which was charged to research and development expense.  On May 24, 2010, Strativa and MonoSol reached a mutual decision to discontinue the development of the first product under the agreement.  On June 22, 2010, MonoSol delivered certain development results for the second product, triggering a 90-day option period during which Strativa could have elected to have MonoSol continue development of the second product.  Strativa did not elect to continue development of the second product.  During the two-year period ending December 9, 2011, Strativa may elect to have MonoSol develop a third product under the agreement.  If Strativa elects to have MonoSol develop the third product, we may make subsequent payments to MonoSol of up to $8,650 thousand, depending upon MonoSol’s achievement of specified development milestones.  Subject to FDA approval, MonoSol would supply commercial quantities of the product under a separate license and supply agreement that would be entered into by the parties, and Strativa would commercialize the product in the United States and pay MonoSol royalties on any future net sales.

In second quarter of 2010, Par acquired the rights and obligations of a collaboration arrangement for a product currently in development for an up-front payment of $5,500 thousand that was expensed as research and development.  The arrangement provides for additional milestone payments of up to $5,500 thousand based upon certain development activities, FDA approval, certain conditions and sales.  The first of such milestones was achieved during the second quarter of 2010, and the resultant $500 thousand payment was expensed as research and development.  Par will participate in a profit sharing arrangement with its third party collaboration partner based on any future sales.  




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Note 18 – Restructuring Costs:


In October 2008, we announced our plans to resize Par Pharmaceutical, our generic products division, as part of an ongoing strategic assessment of our businesses.  Accordingly, we have reduced our research and development expenses by decreasing our internal generic research and development effort and we have trimmed our generic products portfolio in an effort to retain only those products that deliver acceptable levels of profit.  These actions resulted in a workforce reduction of approximately 190 positions in manufacturing, research and development, and general and administrative functions.  In connection with these actions, we incurred expenses for severance and other employee-related costs.  In addition, we made the determination to abandon or sell certain assets that resulted in asset impairments, and accelerated depreciation expense.  Under this plan, Par is continuing to concentrate its efforts on completing a more focused portfolio of generic products and will continue to look for opportunities with external partners.  

 

The following table summarizes the activity for the three-month period of 2010 and the remaining related restructuring liabilities balance (included in accrued expenses and other current liabilities on the condensed consolidated balance sheet) as of March 31, 2011 ($ amounts in thousands):

Restructuring Activities

 

Initial Charge

 

Liabilities at December 31, 2010

 

Cash Payments

 

Additional Charges

 

Reversals, Reclass or Transfers

 

Liabilities at March 31, 2011

Severance and employee
    benefits to be paid in cash

 

$6,199

 

$68

 

$68

 

$ -

 

$ -

 

$ -

Severance related to share-
   based compensation

 

3,291

 

-

 

-

 

-

 

-

 

-

Asset impairments and other

 

5,907

 

-

 

-

 

-

 

-

 

-

Total

 

$15,397

 

$68

 

$68

 

$ -

 

$ -

 

$ -


 



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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, 2010, 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”), our proprietary products division.   

The introduction of new products at selling prices 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.  Par’s 2010 and year-to-date 2011 achievements included several product launches (generic versions of Zegerid®, Tussionex®, Accolate®, Rythmol SR®, Lotrel®), the filing of 10 ANDAs in conjunction with its development partners, and execution of several collaboration agreements to sustain the future generic pipeline.  As a result, we believe we are well positioned to compete in the generic marketplace over the long term.  Our internal research and development targets high-value, first-to-file Paragraph IVs or first-to-market product opportunities.  Externally, we intend to concentrate on acquiring assets and/or partnering with technology based companies that can deliver similar product opportunities.  As of March 2011, we had 12 confirmed first-to-file and two potential first-to-market 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 net sales) to our strategic partners.    

To continue the development of our branded products division, Strativa Pharmaceuticals, we acquired the worldwide rights to Nascobal® on March 31, 2009.  Nascobal® 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.  Strativa also launched two products in 2010: Zuplenz®, which is an oral soluble film formulation of ondansetron for the prevention of chemotherapy-induced nausea and vomiting, prevention of nausea and vomiting associated with radiotherapy, and prevention of post-operative nausea and vomiting, and OravigTM, which is an antifungal therapy for the treatment of oropharyngeal candidiasis, an opportunistic infection commonly found in immunocompromised patients, including those with HIV and cancer.       

Sales and gross margins of our products depend principally on (i) 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 products (Nascobal®, OravigTM, Zuplenz®) and the successful development and commercialization of our future in-licensed branded product pipeline.





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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

On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (PPACA) and on March 30, 2010, President Obama signed into law the Health Care and Education Reconciliation Act, which includes a number of changes to the PPACA.  These laws are hereafter referred to as “healthcare reform” or the “Acts.”  


A number of provisions of healthcare reform have had and will continue to have a negative impact on the price of our products sold to U.S. government entities.  The significant provisions that impacted our first quarter 2011 net revenues, gross margin and net income include, but are not limited to the following (all items were effective January 1, 2010 unless otherwise noted):    

·

Increase in the Medicaid rebate rate.  The base rebate rate on sales of branded drugs (Strativa) and authorized generics (Par) into the Medicaid channel was increased from 15.1% of AMP (average manufacturer price) to 23.1% of AMP.  The base rebate on sales of multisource generic products (Par) into the Medicaid channel was increased from 11% of AMP to 13% of AMP.  The base rebate is one component of the calculation for branded drugs and authorized generics, and may or may not result in an increase in rebates for a particular product.

·

Effective March 23, 2010, there was an extension of Medicaid rebates to drugs consumed by patients enrolled in Medicaid Managed Care Organizations (MMCOs).  Prior to healthcare reform, MMCOs were not entitled to Medicaid rebates, as the drug benefit was independently managed by the commercial managed care entity.  Given our current product portfolio, which is weighted more toward generic products, our exposure to commercial rebates for patients enrolled in MMCOs was low prior to March 23, 2010.

·

Increased Medicaid rebates for products defined as a line extension through application of an inflation penalty back to the original formulation price.

·

Expansion of the number of entities qualifying for Public Health System (PHS) status and therefore eligible to receive PHS pricing, which is typically equal to the net Medicaid price after rebates.

·

Revisions to the AMP calculation, effective October 1, 2010.  This provision had a negligible effect on first quarter 2011 net revenues and gross margins.

·

Change in the Federal Upper Limit as it relates to the pharmacy reimbursement of multisource drugs. This provision is expected to reduce the Medicaid funding from the federal government.  While it is impractical to quantify the impact of the provision, it is expected to result in increased pressure at the state level to drive Medicaid utilization to low cost alternatives such as generic products.


  In 2011, the following provisions went into effect:

·

An annual, non tax deductible, pharmaceutical fee to be assessed by the Secretary of the Treasury on any manufacturer or importer with gross receipts from the sale of branded prescription and authorized generic drugs to the following government programs and entities: Medicare Part D, Medicare Part B, Medicaid, Department of Veterans Affairs, Department of Defense, and Tricare.  The total pharmaceutical fee, which is set at $2.5 billion for 2011, will be allocated across the pharmaceutical industry based upon relative market share into these programs.  The total fee increases each year thereafter, reaching $4.1 billion in 2018.

The market share calculation utilized to allocate the fee is to be calculated utilizing prior years sales statistics.  Based upon



30



internal estimates of total industry sales into specified government programs, we currently estimate the impact of the pharmaceutical fee on our 2011 net income to be between $0.8 million and $4.6 million.  In addition, the year to year impact of this provision of healthcare reform will be highly variable depending on:

o

the volume of Par’s sales of authorized generics, which can vary dramatically based upon our ability to continue to secure authorized generic business development opportunities,

o

the volume of Strativa’s sales of branded products, and  

o

our ability to share portions of this fee with partners under pre-existing distribution agreements.  

·

A new 50% discount on cost for certain Medicare Part D beneficiaries for certain drugs, including branded and authorized generic pharmaceuticals, purchased during the Part D Medicare coverage gap (commonly referred to as the “donut hole”).   The 2011 impact of this provision on the gross margin of Par is estimated to be approximately $2 million to $3 million and Strativa is estimated to be less than $0.8 million.  

·

Additionally, the publication of monthly weighted average AMP by therapeutic class and retail price surveys could occur during 2011.   It is not practical to forecast the impact of this provision on 2011 net revenues or gross margin.  

For the quarter ended March 31, 2011, the impact of healthcare reform resulted in a decrease of approximately $4.7 million to our net revenue, approximately $2.4 million to our gross margin, and approximately $2.7 million to our net income.  The gross margin impact of these provisions is highly dependent upon product sales mix between products that are partnered with third parties and non-partnered products.

Any potential impact of healthcare reform on the future demand for our products is not determinable at this time.  Any potential future impact on demand could differ between our Par and Strativa divisions, as well as between individual products within each division.

Par Pharmaceutical - Generic Products Division

Our strategy for our generic 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, we are able to effectively and efficiently pursue these opportunities and support our partners.

In the three month period ended March 31, 2011, our generic business net revenues and gross margin were concentrated in a few products.  The top generic revenue products (metoprolol succinate ER (metoprolol), propafenone, amlodipine and benazepril HCL, sumatriptan, chlorpheniramine/hydrocodone, dronabinol, tramadol ER, the clonidine transdermal system (clonidine), and meclizine) accounted for approximately 67% of our total consolidated revenues in the three month period ended March 31, 2011 and for approximately 56% of total consolidated gross margins in the three month period ended March 31, 2011.  

We began selling metoprolol in the fourth quarter of 2006 as the authorized generic distributor pursuant to a supply and distribution agreement with AstraZeneca.  There had been two competitors marketing generic metoprolol until the fourth quarter of 2008, when those two companies stopped selling metoprolol due to violations of the FDA’s current Good Manufacturing Practices.  Throughout the first two quarters of 2009, we did not have competition for sales of the four SKUs (packaging sizes) of metoprolol that we sell, which resulted in increased volume of units sold coupled with a price increase commensurate with being the sole generic distributor.  Watson Pharmaceuticals announced in August 2009, however, that the FDA had approved two of its ANDAs for metoprolol, and accordingly, we were no longer the sole distributor for those two SKUs (25mg and 50mg).  On April 15, 2010, Watson announced that the FDA had approved its two other ANDAs for metoprolol, and Par was no longer the sole distributor for the 100mg and 200mg SKUs.  Our sales volume and unit price for metoprolol were adversely impacted subsequent to each of Watson’s entries into the market. In addition, Wockhardt, an India-based pharmaceutical company, announced that it received FDA approval for all four strengths of metoprolol on July 23, 2010.  Our sales volume and unit price for metoprolol were adversely impacted by this second generic competitor.  Additional competitors on any or all of the four SKUs will result in significant additional declines in sales volume and unit price, which would negatively impact our revenues and gross margins (including possible inventory writedowns) as compared to 2010.  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 August 2009, we launched clonidine TDS, the generic version of Boehringer Ingelheim’s Catapres TTS®.  The product was manufactured by Aveva Drug Delivery Systems, Inc., our third party development partner, with whom we have a profit sharing arrangement.  From launch to July 15, 2010, we were the sole generic distributor of this product.  On July 16, 2010, Mylan received FDA approval for its generic version of clonidine TDS, therefore we were no longer the sole generic distributor.  Our sales and related gross margins for clonidine TDS were negatively impacted due to Mylan’s receipt of FDA approval and subsequent launch.  In May 2010, Aveva, the manufacturer of our product, received a Warning Letter from the FDA that cited conditions at the facility where clonidine TDS is manufactured that the FDA investigators believe may violate current Good Manufacturing Practices, based on their observations made between October and December of 2009.  In April 2011, Aveva decided to discontinue manufacturing clonidine and the product was voluntarily withdrawn from the distribution channel.  Because of these events, Par has discontinued marketing clonidine.      



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In the fourth quarter of 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.  From the beginning of 2009 to March 31, 2011, we remained the sole generic distributor of three SKUs with one competitor for a single SKU. The remaining net book value of the associated intangible asset was $0.5 million at March 31, 2011 and will be amortized over approximately one year.      

We marketed meclizine until the supplier of our active pharmaceutical ingredient (“API”) experienced an explosion at its manufacturing facility in early 2008.  Subsequently, we qualified a new API source and received the appropriate approval from the FDA of our ANDA to manufacture and market meclizine utilizing our new supplier.  We reintroduced meclizine HCl tablets in 12.5mg and 25mg strengths in 2008.  From the beginning of 2009 to May 2010, we were the exclusive supplier of this generic product.  In June 2010, a competitor entered this market.   This new competition negatively impacted our sales and gross margins for meclizine.  Any additional competition could result in significant additional declines in sales volume and unit price, which may negatively impact our revenues and gross margins (including possible inventory writedowns) as compared to 2010.

In November 2009, we launched tramadol ER, the generic version of Ultram® ER, after a favorable court ruling in the related patent matter.  We are one of two competitors in this market, with the other competitor being the authorized generic.  We manufacture and distribute this product.  

In July 2010, we launched two strengths of omeprazole/sodium bicarbonate capsules, the generic version of Zegerid®.  We were awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for these two strengths of the product.  We are now one of two competitors in this market, with the other competitor being the authorized generic.  Omeprazole/sodium bicarbonate capsules had been the subject of litigation in the U.S. District Court for the District of Delaware, but in April 2010, the Court ruled in our favor, finding that the related patents were invalid as being obvious and without adequate written description.  The case is currently on appeal to the U.S. Court of Appeals for the Federal Circuit.  We will continue to vigorously defend the appeal.  

In the third quarter of 2008, we launched dronabinol in 2.5mg, 5mg and 10mg strengths in soft gel capsules.  We believe we are one of two generic distributors of dronabinol.  We share net product margin, as contractually defined, on sales of dronabinol with SVC Pharma LP, an affiliate of Rhodes Technologies.  The remaining net book value of the associated intangible asset was $1.1 million at March 31, 2011 and will be amortized over approximately three years.

On October 5, 2010, we announced that our licensing partner, Tris Pharma, Inc., had 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).  Hydrocodone polistirex and chlorpheniramine polistirex (CIII) ER oral suspension is a generic version of UCB’s Tussionex®.  We participate in a profit sharing arrangement with Tris Pharma 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 into the foreseeable future by Drug Enforcement Administration regulations concerning allowable commercial quantities of controlled substances like hydrocodone, which is contained in generic Tussionex®.  In October 2010, UCB filed a complaint naming us, our development partner Tris Pharma, and Tris Pharma’s head of research and development as defendants.  The complaint alleged that Tris and its head of research and development misappropriated UCB’s trade secrets and, by their actions, breached contracts and agreements to which they were bound.  The complaint further alleges unfair competition against the defendants 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.  We intend to continue vigorously defending the lawsuit.    

In addition, our investments in generic product development, including projects with development partners, are expected to yield approximately 5 to 7 new ANDA filings during each of 2011, 2012 and 2013.  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, 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 currently have approximately 30 ANDAs pending with the FDA, which include 12 first-to-file and two first-to-market 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 product portfolio.  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.   



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In July 2005, we received FDA approval for our first NDA, and immediately 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.  The remaining net book value of the trademark was $2.2 million at March 31, 2011, and will be amortized over approximately two years.  We promoted Megace® ES as our primary brand product from 2005 through March 2009.  With the acquisition of Nascobal® in March 2009 and the FDA approvals of OravigTM and Zuplenz® in 2010, Strativa increased its sales force and turned its focus on marketing the full portfolio of products.       

In September 2006, we entered into an extended-reach agreement with Solvay Pharmaceuticals, Inc. (which was subsequently acquired by Abbott Laboratories) that provided for our branded sales force to co-promote Androgel® for a period of six years.  As compensation for our marketing and sales efforts, we were receiving up to $10 million annually.  In December 2010, we terminated this agreement and received a $2 million early termination payment.  The marketing and sales efforts will be redirected toward the four products currently in the portfolio.  

In July 2007, we entered into an exclusive licensing agreement with BioAlliance Pharma to acquire the U.S. commercialization rights to BioAlliance's OravigTM (miconazole) buccal tablets.  On April 16, 2010, the FDA approved OravigTM, which triggered our payment to BioAlliance of $20.0 million in the second quarter of 2010.  Strativa began to commercialize OravigTM, which is supplied by BioAlliance, during the third quarter of 2010.  In addition to paying BioAlliance royalties on net sales, BioAlliance may also receive additional milestone payments if commercial sales achieve specified sales targets.  The remaining net book value of the related intangible asset was $19.0 million at March 31, 2011, and will be amortized over approximately 12 years.

In June 2008, we entered into an exclusive licensing agreement with MonoSol Rx to acquire the U.S. commercialization rights to MonoSol’s Zuplenz® (ondansetron) oral soluble film.  On July 2, 2010, the FDA approved Zuplenz®, which is offered in 4mg and 8mg dosage strengths, and Strativa launched Zuplenz® in the fourth quarter of 2010.  We paid MonoSol additional milestone payments totaling $6.0 million in July 2010.  The product is manufactured and supplied by MonoSol.  In addition to royalties on net sales, MonoSol may receive milestone payments if commercial sales achieve specified sales targets.  The remaining net book value of the related intangible asset was $5.8 million at March 31, 2011, and will be amortized over approximately 10 years.

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 $45.6 million at March 31, 2011, and will be amortized over approximately 10 years.  

In January 2011, we completed a modest reorganization of the Strativa management team (approximately 10 positions eliminated) and refined our sales and marketing plan for each of Strativa’s currently marketed products as part of our on-going efforts to maximize the value and potential of our existing product portfolio.  We announced that the President of Strativa Pharmaceuticals resigned and that effective January 31, 2011, Patrick G. LePore, the Chairman, CEO and President of Par Pharmaceutical Companies, Inc., assumed day-to-day oversight of Strativa on an interim basis.  We have taken steps to further align the Strativa home office sales and marketing team with the objectives of our sales force and to leverage the relevant expertise and experience within our Par Pharmaceutical generics division.    


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 name 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 branded 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 branded 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 risk that a branded 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.



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RESULTS OF OPERATIONS

Results of operations, including segment net revenues, segment gross margin and segment operating income (loss) information for our Par Pharmaceutical - Generic Products segment and our Strativa Branded Products segment, consisted of the following:

Revenues

Total revenues of our top selling products were as follows:

 

 

Three months ended

($ amounts in thousands)

 

March 31,

March 31,

 

Product

 

2011

2010

$ Change

     Par Pharmaceutical

 

 

 

 

Metoprolol succinate ER (Toprol-XL®)

 

$63,418

$183,291

($119,873)

Propafenone (Rythmol SR®)

 

22,039

-

22,039 

Amlodipine and Benazepril HCI (Lotrel®)

 

18,171

-

18,171 

Sumatriptan succinate injection (Imitrex®)

 

16,699

17,284

(585)

Chlorpheniramine/Hydrocodone (Tussionex®)

 

12,679

-

12,679 

Dronabinol (Marinol®)

 

6,871

4,091

2,780 

Tramadol ER (Ultracet ER®)

 

6,081

5,286

795 

Clonidine TDS (Catapres TTS®)

 

5,806

18,461

(12,655)

Meclizine Hydrochloride (Antivert®)

 

4,875

10,154

(5,279)

Other

 

45,217

32,318

12,899 

Other product related revenues

 

7,889

1,154

6,735 

Total Par Pharmaceutical Revenues

 

$209,745

$272,039

($62,294)

 

 

 

 

 

     Strativa

 

 

 

 

Megace® ES

 

$14,085

$13,798

$

287 

Nascobal® Nasal Spray

 

3,878

3,595

283 

OravigTM

 

749

-

749 

Zuplenz®

 

221

-

221 

Other product related revenues

 

4,274

2,500

1,774 

Total Strativa Revenues

 

$23,207

$19,893

$

3,314 


 

 

Three months ended

 

 

 

 

 

 

Percentage of Total Revenues

 

 

March 31,

 

March 31,

 

 

 

 

 

March 31,

 

March 31,

($ in thousands)

 

2011

 

2010

 

$ Change

 

% Change

 

2011

 

2010

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

   Par Pharmaceutical

 

$209,745

 

$272,039

 

($62,294)

 

(22.9%)

 

90.0%

 

93.2%

   Strativa

 

23,207

 

19,893

 

3,314

 

16.7%

 

10.0%

 

6.8%

Total revenues

 

$232,952

 

$291,932

 

($58,980)

 

(20.2%)

 

100.0%

 

100.0%


The decrease in generic segment revenues in the first quarter of 2011 was primarily due to;

·

Additional competition on all SKUs (packaging sizes) of metoprolol succinate ER.  The dollar amount decrease of metoprolol revenues for the first quarter of 2011 can be attributed to a decrease in the volume of units sold (approximately 65% of total dollar decrease) with the remainder of the dollar amount decrease due to price.  We expect metoprolol revenues to continue to decline in the future as more competitors enter this market.  

·

We launched clonidine in August 2009 as the sole generic distributor, and we remained the exclusive supplier to this market on all strengths through August 2010.  On July 16, 2010, Mylan received FDA approval for clonidine and subsequently launched its product, therefore we were no longer the sole generic distributor.  Our sales and related gross margins for clonidine TDS were negatively impacted.  In April 2011, the manufacturer of our product, Aveva decided to discontinue manufacturing clonidine and the product was voluntarily withdrawn from the distribution channel.  Because of these events, Par has discontinued marketing clonidine.

·

Additional competition for meclizine beginning in June 2010.  



34



The decreases above in the first quarter of 2011 were tempered by;

·

The launches of propafenone and amlodipine and benazepril HCl in January 2011 and the launch of chlorpheniramine/hydrocodone in October 2010.      

·

The increase of net sales of dronabinol, mainly due to volume increase.  Our only competitor in the dronabinol market continues to be Watson as the authorized generic.  

·

The increase in “Other” Par Pharmaceutical first quarter 2011 revenues as compared to first quarter 2010 was primarily driven by the launch of omeprazole in late June 2010, the launch of zafirlukast in November 2010, the improvement of nateglinide net sales mainly due to increased volume as more supply was available as compared to the first quarter of 2010 when this product was on backorder, the net sales improvement of calcitonin nasal spray mainly due to a competitor’s supply issues that led to our market share gain, and the net sales improvement of fluoxetine due to market share gains in fourth quarter of 2010 and the first quarter of 2011.      

·

Improved royalties primarily from the sales of diazepam, which launched in September 2010 and is included in Par Pharmaceutical first quarter 2011 “Other product related revenues”.      

 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 53% of our total product revenues for the three month period ended March 31, 2011 and approximately 78% of our total product revenues for the three month period ended March 31, 2010.  The decrease in the percentage is primarily driven by decreased revenues of metoprolol and clonidine combined with the launches of propafenone, amlodipine and benazepril HCl, and omeprazole.  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 increase in the Strativa segment revenues in the first quarter of 2011 was primarily due to the increase in other product related revenues driven by the $4.3 million royalty earned from Strativa’s share of the proceeds from Optimer Pharmaceuticals’ sale of certain rights in fidaxomicin to a third party, coupled with the 2010 launches of OravigTM and Zuplenz® and the continued growth of Nascobal®.   The net sales increase of Megace® ES was primarily due to a single digit increase in average net selling price.   

Strativa launched OravigTM in the third quarter of 2010 and Zuplenz® in the fourth quarter of 2010.  In connection with the launches, our direct customers ordered, and we shipped, OravigTM and Zuplenz® units at a level commensurate with initial forecasted demand for the product.  Due to our relatively limited history in the branded pharmaceutical marketplace, it is impractical to predict with reasonable certainty the rate of OravigTM’s and Zuplenz®’s prescription demand uptake and ultimate acceptance in the marketplace.  Therefore, during the initial launch phase of OravigTM and Zuplenz®, we will recognize revenue and all associated cost of sales as the product is prescribed to patients based on an analysis of third party market prescription data, third party wholesaler inventory data, order refill rates, and all substantive quantitative and qualitative data available to us at the time.  Accordingly, for the three month period ended March 31, 2011, we have recognized $0.7 million of OravigTM revenues and $0.2 million of revenues for Zuplenz® and deferred revenues of $0.8 million for OravigTM and deferred revenues of $0.5 million for Zuplenz®, related to product that has been shipped to customers but not yet been prescribed to patients.  We will modify our revenue recognition for OravigTM and Zuplenz® at the time that we have sufficient data and history to reliably estimate trade inventory levels in relation to forward looking demand.  


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.


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.  



35




Our gross revenues for the three month periods ended March 31, 2011 and March 31, 2010 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:


 

 

Three months ended

($ thousands)

 

March 31,
2011

 

Percentage of Gross Revenues

 

March 31,
2010

 

Percentage of Gross Revenues

Gross revenues

 

$

363,941 

 

 

 

$

406,488 

 

 

 

 

 

 

 

 

 

 

 

Chargebacks

 

(58,761)

 

16.1%

 

(47,462)

 

11.7%

Rebates and incentive programs

 

(25,597)

 

7.0%

 

(34,313)

 

8.4%

Returns

 

(6,829)

 

1.9%

 

(4,437)

 

1.1%

Cash discounts and other

 

(25,631)

 

7.0%

 

(16,104)

 

4.0%

Medicaid rebates and rebates due
   under other US Government
   pricing programs

 

(14,171)

 

3.9%

 

(12,240)

 

3.0%

Total deductions

 

(130,989)

 

36.0%

 

(114,556)

 

28.2%

 

 

 

 

 

 

 

 

 

Total revenues

 

$

232,952 

 

64.0%

 

$

291,932 

 

71.8%

 

The total gross-to-net adjustments as a percentage of sales increased for the three months ended March 31, 2011 compared to the three months ended March 31, 2010 primarily due to an increase in chargebacks, cash discounts and other and Medicaid rebates and rebates due under other U.S. Government pricing programs.


·

Chargebacks: the increase in the percentage of gross revenues was primarily driven by a significant decrease in sales of products that carry lower than average chargeback rates, mainly metoprolol, coupled with a decrease in the percentage of non-wholesaler sales, which do not earn a chargeback, and we also experienced higher chargeback rates for certain products that had no competition in first quarter of 2010.    

·

Cash discounts and other: the increase is primarily due to a change in customer mix, mainly for metoprolol, which resulted in higher price adjustments and other adjustments given major customers to retain their business.

·

Rebates and incentive programs: the decrease in percentage of gross revenues was primarily driven by product mix, mainly metoprolol, and the impact of new product launches at a lower rate.

·

Medicaid rebates and rebates due under other U.S. Government pricing programs: expense increase was due to the full quarter impact of the March 2010 health care reform acts which led to higher Medicaid rebates rates and additional patients eligible for managed Medicaid benefits coupled with the Medicare Part D - Gap Coverage which was effective in the first quarter of 2011.  

The following tables summarize the activity for the three months ended March 31, 2011 and March 31, 2010 in the accounts affected by the estimated provisions described above ($ amounts in thousands):


 

 

Three Months Ended March 31, 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)

 

($58,761)

 

$

 

$59,828

 

($18,415)

Rebates and incentive programs

 

(23,273)

 

(26,257)

 

660 

 

24,916

 

(23,954)

Returns

 

(48,928)

 

(7,094)

 

265 

 

4,341

 

(51,416)

Cash discounts and other

 

(16,606)

 

(25,274)

 

(357)

 

24,976

 

(17,261)

                  Total

 

($108,289)

 

($117,386)

 

$

568 

 

$114,061

 

($111,046)

 

 

 

 

 

 

 

 

 

 

 

Accrued liabilities (2)

 

($32,169)

 

($14,587)

 

$

416 

 

$15,969

 

($30,371)

 

36



 

 

Three Months Ended March 31, 2010

Accounts receivable reserves  

 

Beginning balance

 

Provision recorded for current period sales

 

(Provision) reversal recorded for prior period sales

 

Credits processed

 

Ending balance

Chargebacks

 

($16,111)

 

($47,385)

 

($77)

(1)

$49,233

 

($14,340)

Rebates and incentive programs

 

(39,938)

 

(33,117)

 

(1,196)

(3)

39,788

 

(34,463)

Returns

 

(39,063)

 

(4,945)

 

508 

 

2,615

 

(40,885)

Cash discounts and other

 

(19,160)

 

(15,446)

 

(658)

 

20,202

 

(15,062)

                  Total

 

($114,272)

 

($100,893)

 

($1,423)

 

$111,838

 

($104,750)

 

 

 

 

 

 

 

 

 

 

 

Accrued liabilities (2)

 

($24,713)

 

($11,395)

 

($845)

 

$4,302

 

($32,651)


 (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)

During the first quarter of 2010, the Company settled a dispute with a major customer and as a result recorded an additional reserve of $1.3 million.

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

 

 

Three months ended

 

 

 

 

Percentage of Total Revenues

 

 

March 31,

 

March 31,

 

 

 

March 31,

 

March 31,

($ in thousands)

 

2011

 

2010

 

$ Change

 

2011

 

2010

Gross margin:

 

 

 

 

 

 

 

 

 

 

   Par Pharmaceutical

 

$92,559

 

$68,443

 

$24,116

 

44.1%

 

25.2%

   Strativa

 

17,093

 

15,067

 

2,026

 

73.7%

 

75.7%

Total gross margin

 

$109,652

 

$83,510

 

$26,142

 

47.1%

 

28.6%


The increase in Par Pharmaceutical gross margin dollars for the three months ended March 31, 2011 is primarily due to the launches of propafenone, amlodipine and benazepril HCl, omeprazole and chlorpheniramine/hydrocodone, tempered by lower sales of metoprolol, clonidine, and meclizine.  

The top sales volume generic products (metoprolol, propafenone, amlodipine and benazepril HCL, sumatriptan, chlorpheniramine/hydrocodone, dronabinol, tramadol ER, clonidine, and meclizine) accounted for approximately $62 million gross margin dollars and a margin percentage of approximately 40% for the first quarter of 2011.  For the first quarter of 2010, these top net revenue products (excluding propafenone, amlodipine and benazepril HCl, and chlorpheniramine/hydrocodone all of which launched after the first quarter of 2010) totaled approximately $52 million gross margin dollars with a margin percentage of approximately



37



22%.  The increase in the gross margin percentage in the first quarter of 2011 for the top sales volume generic products compared to the first quarter of 2010 is primarily due to the launches higher gross margin percentage products like propafenone, and amlodipine and benazepril HCl, coupled with declines in lower gross margin percentage products like metoprolol and clonidine.   

Gross margin dollars related to all other Par generic revenues totaled approximately $31 million with a margin percentage of approximately 58% for the first quarter of 2011.  For the first quarter of 2010, gross margin dollars for all other generic revenues totaled approximately $16 million with a margin percentage of approximately 49%.  Gross margin dollars and gross margin percentage for these revenue streams were mainly improved by launch of omeprazole in late June 2010 and royalties from the sales of diazepam, which launched in September 2010.        

Strativa gross margin dollars increased for the three months ended March 31, 2011, primarily due to the increase in other product related revenues driven by the $4.3 million royalty earned from Strativa’s share of the proceeds from Optimer Pharmaceuticals’ sale of certain rights in fidaxomicin to a third party, coupled with the continued growth of Nascobal®.     



Operating Expenses


Research and Development

 

 

Three months ended

 

 

 

 

 

 

Percentage of Total Revenues

 

 

March 31,

 

March 31,

 

 

 

 

 

March 31,

 

March 31,

($ in thousands)

 

2011

 

2010

 

$ Change

 

% Change

 

2011

 

2010

Research and development:

 

 

 

 

 

 

 

 

 

 

 

 

   Par Pharmaceutical

 

$10,077

 

$4,086

 

$5,991

 

146.6%

 

4.8%

 

1.5%

   Strativa

 

633

 

566

 

67

 

11.8%

 

2.7%

 

2.8%

Total research and development

 

$10,710

 

$4,652

 

$6,058

 

130.2%

 

4.6%

 

1.6%



Par Pharmaceutical:

The increase in Par Pharmaceutical research and development expense for the three month period ended March 31, 2011 is driven by higher biostudy and material costs, combined worth $4.9 million, and higher outside development costs, worth $0.7 million, related to the ongoing development of generic products.


Strativa:

Strativa research and development principally reflects FDA filing fees for the three months ended March 31, 2011 and March 31, 2010.



Selling, General and Administrative Expenses

 

 

Three months ended

 

 

 

 

 

 

Percentage of Total Revenues

 

 

March 31,

 

March 31,

 

 

 

 

 

March 31,

 

March 31,

($ in thousands)

 

2011

 

2010

 

$ Change

 

% Change

 

2011

 

2010

Selling, general and administrative:

 

 

 

 

 

 

 

 

 

 

 

 

   Par Pharmaceutical

 

$24,668

 

$19,048

 

$5,620

 

29.5%

 

11.8%

 

7.0%

   Strativa

 

22,277

 

22,187

 

90

 

0.4%

 

96.0%

 

111.5%

Total selling, general and administrative

 

$46,945

 

$41,235

 

$5,710

 

13.8%

 

20.2%

 

14.1%


The net increase in SG&A expenditures principally reflects:

·

$4.9 million of incremental legal costs driven by activities in ongoing AWP litigation, the Department of Justice matter, and ANDA litigation matters; and

·

$0.7 million of higher severance costs related to the first quarter 2011 modest restructuring of our Strativa management team.


Overall, total Strativa sales and marketing costs were essentially flat as incremental direct selling costs related to our third quarter 2010 field force expansion of approximately 60 employees were tempered by lower direct marketing cost.





38



Settlements and Loss Contingencies, net



 

 

Three months ended

 

 

March 31,

 

March 31,

($ in thousands)

 

2011

 

2010

Settlements and loss contingencies, net

 

$190,560

 

$62


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.  



Gain on Sale of Product Rights and other

 

 

Three months ended

 

 

March 31,

 

March 31,

($ in thousands)

 

2011

 

2010

Gain on sale of product rights and other

 

$ -

 

$5,775


In the first quarter of 2010, Optimer Pharmaceuticals announced positive results from the second of two pivotal Phase 3 trials evaluating the safety and efficacy of fidaxomicin in patients with clostridium difficile infection (CDI), triggering a one-time $5 million milestone payment due to us under a termination agreement entered into by the parties in 2007.  The cash payment was received in the second quarter of 2010.   Under the terms of the 2007 agreement, we are also entitled to royalty payments on future sales of fidaxomicin.  


In addition, we recognized a gain on the sale of product rights of $0.8 million during the three-month period ended March 31, 2010, related to the sale of multiple ANDAs.  



Operating (Loss) Income

 

 

Three months ended

 

 

March 31,

 

March 31,

 

 

($ in thousands)

 

2011

 

2010

 

$ Change

Operating (loss) income:

 

 

 

 

 

 

   Par Pharmaceutical

 

($132,746)

 

$46,022

 

($178,768)

   Strativa

 

(5,817)

 

(2,686)

 

(3,131)

Total operating (loss) income

 

($138,563)

 

$43,336

 

($181,899)


The decrease in our operating income in the three month period ended March 31, 2011 as compared to the prior year was primarily due to the AWP settlement in principal related accruals, increased R&D expenditures in our Par Pharmaceutical segment and higher legal fees tempered by an increase in gross margin from our Par Pharmaceutical segment.



Interest Income


 

 

Three months ended

 

 

March 31,

 

March 31,

($ in thousands)

 

2011

 

2010

Interest income

 

$423

 

$328


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



Interest Expense


 

 

Three months ended

 

 

March 31,

 

March 31,

($ in thousands)

 

2011

 

2010

Interest expense

 

($150)

 

($908)

 

 

 

 

39



Interest expense in the three month period ended March 31, 2011, was principally comprised of amortization of deferred financing costs relating to our October 1, 2010 Credit Agreement.  We have not drawn on the revolving credit facility as of the date of this Quarterly Report on Form 10-Q.    


Interest expense in the three month period ended March 31, 2010, related to our senior subordinated convertible notes which matured on September 30, 2010.        



Income Taxes

 

 

Three months ended

 

 

March 31,

 

March 31,

($ in thousands)

 

2011

 

2010

(Benefit) provision for income taxes

 

($29,446)

 

$16,330

Effective tax rate

 

21%

 

38%


The provisions were based on the applicable federal and state tax rates for those periods (see Notes to Condensed Consolidated Financial Statements - Note 9 – “Income Taxes”).  The effective tax rate for the three months ended March 31, 2011 is reduced by our estimate of the portion of legal settlements and settlement in principal in the quarter which may not be tax deductible and by non-deductibility of our portion of healthcare reforms pharmaceutical manufacturer fee.


Discontinued Operations


 

 

Three months ended

 

 

March 31,

 

March 31,

($ in thousands)

 

2011

 

2010

Provision for income taxes

 

$127

 

$128

Loss from discontinued operations

 

($127)

 

($128)


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  

 

 

Three months ended

 

 

March 31,

($ in thousands)

 

2011

Cash and cash equivalents at beginning of period

 

$

218,674 

Net cash provided by operating activities

 

42,002 

Net cash used in investing activities

 

(4,439)

Net cash used in financing activities

 

(64)

Net increase in cash and cash equivalents

 

$

37,499 

Cash and cash equivalents at end of period

 

$

256,173 

Cash provided by operations for the three months ended March 31, 2011, reflects increased gross margin dollars generated from revenues coupled with inventory draw downs and slower outflows to distribution partners tempered by slower inflows from customers (net accounts receivables growth) relative to net revenue activity.  Cash flows used by investing activities were primarily driven by capital expenditures and the net investment in available for sale debt securities.  Cash used in financing activities in the three month period ended March 31, 2011 mainly represented the payment of withholding taxes related to the vesting of restricted shares coupled with the partial cash settlement of restricted stock grants with market vesting conditions tempered by the proceeds from stock option exercises.       


Our working capital, current assets minus current liabilities, of $254 million at March 31, 2011 decreased approximately $111 million from $365 million at December 31, 2010, which primarily reflects the AWP settlement in principal related accruals at March 31, 2011 tempered by the cash generated by operations.  The working capital ratio, which is calculated by dividing current assets by current liabilities, was 1.81x at March 31, 2011 compared to 4.28x at December 31, 2010.  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.  



40



Detail of Operating Cash Flows


 

 

Three months ended

 

 

March 31,

 

March 31,

($ in thousands)

 

2011

 

2010

Cash received from customers, royalties and other

 

$

229,545 

 

$

295,285 

Cash paid for inventory

 

(30,573)

 

(29,082)

Cash paid to employees

 

(50,088)

 

(29,683)

Cash paid to all other suppliers and third parties

 

(98,375)

 

(196,449)

Interest received (paid), net

 

568 

 

(197)

Income taxes paid, net

 

(9,075)

 

(2,539)

Net cash provided by operating activities

 

$

42,002 

 

$

37,334 


Sources of Liquidity

Our primary source of liquidity is cash received from customers.  The decrease for the first quarter of 2011 as compared to the prior year comparable period can be attributed to lower cash receipts from customers, as detailed above, driven primarily by lower net revenues for metoprolol.  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 consists of approximately 30 ANDAs pending with the FDA, including 12 first-to-file and two first-to-market opportunities.  Strativa launched OravigTM in the third quarter of 2010 and launched Zuplenz® in the fourth quarter of 2010.  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.  

Another source of potential liquidity is the capital markets.  We filed a “shelf” registration statement during the second quarter of 2009, under which we may sell a combination of common stock, preferred stock, debt securities, or warrants from time to time for an aggregate offering price of up to $150 million.  

Effective October 1, 2010, we also entered into a $75 million unsecured credit facility with JP Morgan as Administrative Agent and US Bank as Syndication Agent.  The credit facility has an accordion feature pursuant to which we can increase the amount available to be borrowed by up to an additional $25 million under certain circumstances.  The credit facility expires on October 1, 2013.  We had no borrowings under the credit facility as of March 31, 2011.   

Uses of Liquidity

Our uses of liquidity and future and potential uses of liquidity include the following:

·

The payment of the $154 million settlement in principal for certain Average Wholesale Prices (“AWP”) 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 second half of 2011.

·

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 any loss, such loss may result in a material impact on our liquidity or financial condition when such liability is paid.  

·

Cash paid for inventory purchases as detailed in “Details of Operating Cash Flows” above.  

·

Cash paid to all other suppliers and third parties as detailed in “Details of Operating Cash Flows” above.   The decrease is mainly due to lower metoprolol sales and sales of other licensed products that resulted in lower amounts paid to partners.   

·

Cash compensation paid to employees as detailed in “Details of Operating Cash Flows” above.  The increase for this period was mainly due to the bonus payments in the first quarter 2011 related to our 2010 operating performance coupled with a larger sales force for Strativa in the first quarter of 2011 as compared to the first quarter of 2010.        

·

The payment of our senior subordinated convertible notes that matured in September 2010 ($47.7 million principal amount).    

·

Cash paid to BioAlliance of $20 million in the second quarter of 2010 as a result of the FDA approval of OravigTM.    



41



·

Cash paid to Glenmark Generics of $15 million in the second quarter of 2010 related to a licensing agreement to market ezetimibe 10 mg tablets, the generic version of Merck’s Zetia®, in the U.S.  

·

Potential liabilities related to the outcomes of audits by regulatory agencies like the IRS or the Office of Inspector General of the Department of Veterans Affairs.  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.  

·

2011 capital expenditures are expected to total approximately $15 million, approximately $4 million of which had been incurred as of March 31, 2011.  

·

Expenditures related to current business development and product acquisition activities.  As of March 31, 2011, the total potential future payments that ultimately could be due under existing agreements related to products in various stages of development were approximately $25 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 $31 million as of March 31, 2011 related primarily to amounts due under profit sharing agreements.  We expect to pay substantially all of the $31 million during the first two months of the second quarter of 2011.  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, 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 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 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 or the first quarter of 2011.  The authorized amount remaining for stock repurchases under the repurchase program was $43.6 million, as of March 31, 2011.  The repurchase program has no expiration date.  

Analysis of available for sale debt securities held as of March 31, 2011

In addition to our cash and cash equivalents, we had approximately $28 million of available for sale marketable debt securities classified as current assets on the condensed consolidated balance sheet as of March 31, 2011.  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 Strativa business, enter into product license arrangements, potentially acquire other complementary businesses and products, and for general corporate purposes.



42



Contractual Obligations as of March 31, 2011

The dollar values of our material contractual obligations and commercial commitments as of March 31, 2011 were as follows ($ in thousands):

 

 

 

 

Amounts Due by Period

 

 

Obligation

 

Total Monetary

 

2011

 

2012 to

 

2014 to

 

2016 and

 

 

 

Obligations

 

 

2013

 

2015

 

thereafter

 

Other

AWP settlement in principal

 

$154,000

 

$154,000

 

$ -

 

$ -

 

$ -

 

$ -

Operating leases

 

15,599

 

3,715

 

7,443

 

4,166

 

275

 

-

Fees related to credit facility

 

656

 

197

 

459

 

-

 

-

 

-

Purchase obligations (1)

 

98,288

 

98,288

 

-

 

-

 

-

 

-

Long-term tax liability (2)

 

43,345

 

-

 

-

 

-

 

-

 

43,345

Severance payments

 

1,725

 

1,251

 

474

 

-

 

-

 

-

Other

 

2,156

 

2,156

 

-

 

-

 

-

 

-

Total obligations

 

$315,769

 

$259,607

 

$8,376

 

$4,166

 

$275

 

$43,345


 (1)

Purchase obligations consist of both cancelable and non-cancelable inventory and non-inventory items.  At March 31, 2011 of the total purchase obligations, approximately $13 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 March 31, 2011, 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.



Financing


Refer to Note 10 – Unsecured Credit Facility for a description of a credit facility obtained on October 1, 2010.        



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, 2010.  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, 2010.



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 March 31, 2011 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 March 31, 2011 and December 31, 2010 ($ amounts in thousands):

 

March 31,

 

December 31,

 

2011

 

2010

Corporate bonds

$28,371

 

$27,866

 

We do not have any financial obligations exposed to significant variability in interest rates.  


 

 

43



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.  An evaluation 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 March 31, 2011.  Based on that evaluation, our management, including our CEO and CFO, concluded that our disclosure controls and procedures were effective as of March 31, 2011.


Changes in Internal Control over Financial Reporting

There have been no changes identified during the quarter ended March 31, 2011 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.  



PART II. OTHER INFORMATION


ITEM 1. 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 adverse 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 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.  We and Messrs. O’Connor and Tarriff have answered the Amended complaint and intend to vigorously defend the consolidated class action. Plaintiffs have filed a motion for class certification which we and the other defendants intend to oppose.


Patent Related Matters


On April 28, 2006, CIMA Labs, Inc. (“CIMA”) and Schwarz Pharma, Inc. (“Schwarz Pharma”) 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.  All 40 claims in the ’981 patent were rejected in two non-final office actions in a reexamination proceeding at the United States Patent and Trademark Office (“USPTO”) on February 24, 2006 and on February 24, 2007.  The ‘392 patent is also the subject of a reexamination proceeding.  On July 10, 2008, the USPTO rejected with finality 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.  On November 25, 2009, plaintiffs requested a rehearing before the USPTO Board of Appeals regarding the ’981 patent.  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.   We intend to vigorously defend this lawsuit and pursue our counterclaims.



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We entered into a licensing agreement with developer Paddock Laboratories, Inc. (“Paddock”) to market testosterone 1% gel, a generic version of Unimed Pharmaceuticals, Inc.’s (“Unimed”) 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 (the “Paddock litigation”).  On September 13, 2006, we acquired from Paddock all rights to the ANDA for the testosterone 1% gel, and the Paddock litigation was resolved by a settlement and license agreement that terminates 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 court-approved settlement in 2006 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 Par’s motion to transfer the FTC lawsuit and the private plaintiffs’ complaints to the U.S. District Court for the Northern District of Georgia.  On July 20, 2009, we filed a motion to dismiss the FTC’s case and on September 1, 2009, we filed a motion to dismiss the private plaintiffs’ cases in the U.S. District Court for the Northern District of Georgia, and on February 23, 2010, the 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 March 11, 2011, the Court of Appeals scheduled oral argument in the appellate case for May 13, 2011.  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 July 6, 2007, Sanofi-Aventis and Debiopharm, S.A. filed a lawsuit against us and our development partner, MN Pharmaceuticals ("MN"), in the U.S. District Court for the District of New Jersey.  The complaint alleges infringement of U.S. Patent Nos. 5,338,874 (the “’874 patent”) and 5,716,988 (the “’988 patent”) after we and MN submitted a Paragraph IV certification to the FDA for approval of 50 mg/10 ml, 100 mg/20 ml, and 200 mg/40 ml oxaliplatin by injection.  On January 14, 2008, following MN's amendment of its ANDA to include oxaliplatin injectable 5 mg/ml, 40 ml vial, Sanofi-Aventis filed a complaint asserting infringement of the '874 and the '988 patents.  MN and we filed our Answer and Counterclaim on February 20, 2008.  On June 18, 2009, the District Court granted summary judgment of non-infringement to several defendants, including us, on the ’874 patent, but to date has not rendered a summary judgment decision regarding the ’988 patent.  On September 10, 2009, the U.S. Court of Appeals for the Federal Circuit reversed the District Court and remanded the case for further proceedings.  On September 24, 2009, Sanofi-Aventis filed a motion for preliminary injunction against defendants who entered the market following the District Court’s summary judgment ruling.  On November 19, 2009, the District Court dismissed all pending motions for summary judgment with possibility of the motions being renewed upon letter request to the Court.  On April 14, 2010, the District Court entered a consent judgment and order agreed to by us, MN, and the plaintiffs, which agreement settled the pending litigation.  In view of this agreement, MN and we will enter the market with generic Eloxatin on August 9, 2012, or earlier in certain circumstances.   

 On October 1, 2007, Elan Corporation, PLC (“Elan”) filed a lawsuit against us and our development partners, IntelliPharmaCeutics Corp. and IntelliPharmaCeutics Ltd. ("IPC"), in the U.S. District Court for the District of Delaware.  On October 5, 2007, Celgene Corporation (“Celgene”) 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 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 mg, 10 mg, 15 mg, and 20 mg dexmethylphenidate hydrochloride extended release capsules.  The complaint in the New Jersey case alleged 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 IPC and we submitted a Paragraph IV certification to the FDA for approval of 5 mg, 10 mg, 15 mg, and 20 mg dexmethylphenidate extended release capsules.  On March 5, 2010 and March 15, 2010, the U.S. District Courts for the Districts of New Jersey and Delaware, respectively, entered stays of the litigation between plaintiffs and us and IPC in view of settlement agreements reached by the parties.  The settlement agreement terms are confidential.

On March 25, 2011, Elan Corporation, PLC (“Elan”) filed a lawsuit against us and our development partners, IntelliPharmaceutics Corp. and IntelliPharmaCeutics Ltd. (“IPC”) in the U.S. District Court for the District of Delaware, and Celgene Corporation (“Celgene”) 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 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 30 mg dexmethylphenidate hydrochloride extended release capsules.  The complaint in the New Jersey case alleged 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 IPC and we submitted a Paragraph IV certification to the FDA for approval of 30 mg dexmethylphenidate extended release capsules.  We intend to vigorously defend and expeditiously resolve these lawsuits.

On September 13, 2007, Santarus, Inc. (“Santarus”) 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



45



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 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 filed our notice of appeal to the Court of Appeals for the Federal Circuit, appealing the District Court’s decision. On December 15, 2010, the District Court granted our motion to dismiss a case brought by AstraZeneca asserting we infringed its rosuvastatin process patents.  We intend to defend all of these actions vigorously.

On November 14, 2008, Pozen, Inc. (“Pozen”) 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 by the Court, 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 through October 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.  We are awaiting the Court’s final decision.     

On April 29, 2009, Pronova BioPharma ASA (“Pronova”) 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.  On June 8, 2010, a new patent, U.S. 7,732,488, which was later listed in the Orange Book, was issued to Pronova.  A second case, involving the claims of the ’488 patent and two other patents not listed in the Orange Book and asserted by the plaintiffs, has a trial date set for January 3, 2012.  A bench trial  in the first case  took place from March 29, 2011 to April 7, 2011.  We intend to continue to defend this action vigorously and pursue our defenses and counterclaims against Pronova.   

On July 1, 2009, Alcon Research Ltd. (“Alcon”) 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. 5,510,383; 5,631,287; 5,849,792; 5,889,052; 6,011,062; 6,503,497; and 6,849,253 because we submitted a Paragraph IV certification to the FDA for approval of 0.004% travoprost ophthalmic solutions and 0.004% travoprost ophthalmic solutions (preserved).  We filed an Answer on August 21, 2009.  The Court rescheduled the end of fact discovery for December 31, 2010 and the end of expert discovery for May 9, 2011.  Trial has yet to be rescheduled.  The Court has set July 1, 2011 as the due date for the pre-trial order.  We intend to defend this action vigorously and pursue our defenses and counterclaims against Alcon.

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.  We filed an answer and counterclaims on August 25, 2010, and an initial Rule 16 conference was held on November 10, 2010.  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.  We intend to appeal that decision.  The Court has presently scheduled the close of expert discovery for July 5, 2011, and the close of fact discovery for August 5, 2011.  A Markman hearing has been scheduled for August 15, 2011.  We intend to defend this action vigorously and pursue all of our defenses and counterclaims against Warner Chilcott and Medeva Pharma.

On September 20, 2010, Schering-Plough HealthCare Products (“Schering-Plough”), Santarus, Inc. (“Santarus”), 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 September 22, 2010, Biovail Laboratories filed a lawsuit against us in the U.S. District Court for the Southern District of New York.  The complaint alleges infringement of U.S. Patent Nos. 7,569,610; 7,572,935; 7,649,019; 7,553,992; 7,671,094; 7,241,805; 7,645,802; 7,662,407; and 7,645,901 because we submitted an ANDA with a Paragraph IV certification to the

46



FDA for approval of extended-release tablets of 174 mg and 348 mg bupropion hydrobromide.  On November 10, 2010, we filed our answer to the complaint.  On November 22, 2010, the Court set a March 31, 2011 deadline for all discovery.  On March 7, 2011, the Court reset the deadline for all discovery to May 18, 2011.   We intend to defend this action vigorously.

On October 4, 2010, UCB Manufacturing, Inc. (“UCB”) 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.  We intend to vigorously defend the lawsuit and any appeal by plaintiffs, should one be filed.

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.  We intend to defend this action vigorously.

On March 23, 2011, we filed a declaratory judgment action against UCB, Inc. and UCB Pharma SA (“UCB”) in the U.S. District Court for the Eastern District of Pennsylvania requesting that the Court render a judgment of invalidity and/or non-infringement of U.S. Patent Nos. 7,858,122 and 7,863,316 in view of our eventual marketing of levetiracetam extended release oral tablets, 500 mg and 750 mg pursuant to our filed ANDA that was accompanied by a Paragraph IV certification.  We intend to vigorously prosecute this action against UCB.

Industry Related Matters


Beginning in September 2003, we, along with numerous other pharmaceutical companies, have been named as a defendant in actions brought by a number of state Attorneys General and municipal bodies within the state of New York, as well as a federal qui tam action brought on behalf of the United States by the pharmacy Ven-A-Care of the Florida Keys, Inc. ("Ven-A-Care") 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.  To date, we have been named as a defendant in substantially similar civil law suits filed by the Attorneys General of Alabama, Alaska, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Mississippi, Oklahoma, South Carolina, Texas and Utah, and also by the city of New York, 46 counties across New York State and Ven-A-Care.  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. Several of these cases have been transferred to the AWP multi-district litigation proceedings pending in the U.S. District Court for the District of Massachusetts for pre-trial proceedings.  The case brought by the state of Mississippi will be litigated in the Chancery Court of Rankin County, Mississippi.  The other cases will likely be litigated in the state or federal courts in which they were filed.  In the Utah suit, the time for responding to the complaint has not yet elapsed.   The Hawaii suit was settled on August 25, 2010 for $2,250 thousand.   The Massachusetts suit was settled on December 17, 2010 for $500 thousand.  The Alabama suit was settled on January 5, 2011 for $2,500 thousand.  The Idaho suit was settled on March 25, 2011 for $1,700 thousand.  On April 27, 2011, we reached a settlement in principle to resolve claims brought by Ven-A-Care, Texas, and Florida, under federal and state law, as well as Alaska, South Carolina, and Kentucky under state law for $154,000 thousand. Upon execution of definitive settlement documents and government and court approvals, the settlement will resolve a lawsuit relating to federal contributions to state Medicaid programs in 49 states (excluding Illinois), and claims of Texas, Florida, Alaska, South Carolina and Kentucky relating to their Medicaid programs. The settlement in principal will eliminate the majority of the alleged damages asserted against us in the various drug pricing litigations and removes all trials that had been scheduled to date. The remaining matters have yet to be scheduled for trial.  We have accrued a $197,100 thousand reserve under the caption “Accrued legal settlements” on our condensed consolidated balance sheet as of March 31, 2011, in connection with the April 27, 2011, settlement in principal and the remaining AWP actions.  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.    


In the civil lawsuit brought by the City of New York and certain counties within the State of New York, the U.S. District Court for the District of Massachusetts entered an order on January 27, 2010, denying the defendants’ motion for summary judgment on plaintiffs’ claims related to the federal upper limit ("FUL") and granting the plaintiffs’ motion for partial summary judgment on FUL-based claims under New York Social Services Law § 145-b for nine drugs manufactured by thirteen defendants, including us. The Court has reserved judgment regarding damages until after further briefing.  On February 8, 2010, we and certain defendants filed a motion to amend the order for certification for immediate appeal, which was opposed by the plaintiffs on February 22, 2010.



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In addition, 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.  During the first quarter of 2011, we continued to engage the respective Attorneys General, the USOPM and the Department of Justice, led by the U.S. Attorneys in the Northern District of Illinois, in discussions concerning these allegations, and we will continue to cooperate if called upon to do so.

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 provided, or are in the process of providing, documents in response to this subpoena to the Department of Justice and will continue to cooperate with the Department of Justice in this inquiry if called upon to do so.

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 adverse 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.


Contingency

In March 2011, we reached a settlement related to the routine post-award contract review of our contract with the Department of Veterans Affairs for the periods 2004 to 2007 with the Office of Inspector General of the Department of Veterans Affairs.  The settlement amount is equal to the loss contingency of approximately $1.1 million, including interest, in accrued expenses and other current liabilities and payables due to distribution agreement partners accrued on our consolidated balance sheet as of December 31, 2010, related to this matter.  Refer to Note 5 - “Accounts Receivable” for more information.    

In December 2010, we submitted to the Texas Health and Human Services Commission (“Texas”) $6,540 thousand resulting from a procedural error relating to pharmacy reimbursement between 1999 and 2006.  This amount was never cashed by Texas.  The obligation related to this item is included with our April 27, 2011 settlement in principal in the associated AWP matter (described above).    



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, 2010, 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, 2010 have not materially changed.  The risks described in our Annual Report 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.



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

Issuer Purchases of Equity Securities(1)

Quarter Ending March 31, 2011



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)

January 1, 2011 through January 31, 2011

 

177,736

 

N/A

 

-

 

-

February 1, 2011 through February 28, 2011

 

335

 

N/A

 

-

 

-

March 1, 2011 through March 31, 2011

 

19,232

 

N/A

 

-

 

1,401,512

Total

 

197,303

 

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



48



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 March 31, 2011.  The repurchase program has no expiration date.

(2)

The total number of shares purchased represents 197,303 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 $31.08 at March 31, 2011.



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 three months ended March 31, 2011, filed on May 5, 2011, formatted in Extensive Business Reporting Language (XBRL): (i) condensed consolidated balance sheets, (ii) condensed consolidated statements of operations, (iii) condensed consolidated statements of cash flows, and (iv) the notes to the condensed consolidated financial statements.



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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:  May 5, 2011

/s/ Michael A. Tropiano                                                      

Michael A. Tropiano

Executive Vice President and Chief Financial Officer





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EXHIBIT INDEX



Exhibit Number

Description


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 three months ended March 31, 2011, filed on May 5, 2011, formatted in Extensive Business Reporting Language (XBRL): (i) condensed consolidated balance sheets, (ii) condensed consolidated statements of operations, (iii) condensed consolidated statements of cash flows, and (iv) the notes to the condensed consolidated financial statements.





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