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8-K - FORM 8K - PAR PHARMACEUTICAL COMPANIES, INC.form8kearningsq22011.htm

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Contact:

Allison Wey

Vice President, Investor Relations and Corporate Affairs

Par Pharmaceutical Companies, Inc.

(201) 802-4000




PAR PHARMACEUTICAL COMPANIES REPORTS

SECOND QUARTER 2011 RESULTS


Reports Adjusted Cash EPS of $0.84

Strativa Restructuring Charge of $27.7 Million Results in GAAP EPS of $0.25



Woodcliff Lake, N.J., August 3, 2011 – Par Pharmaceutical Companies, Inc. (NYSE:PRX) today reported results for the second quarter ended June 30, 2011.


For the second quarter ended June 30, 2011, the Company reported total revenues of $224.2 million, and income from continuing operations of $9.2 million, or $0.25 per diluted share, which included a one-time charge of $27.7 million related to the Company’s restructuring of its branded division, Strativa Pharmaceuticals. Excluding this item and a one-time tax charge, adjusted income from continuing operations (non-GAAP measure) was $29.0 million. On an adjusted cash basis (non-GAAP measure), which excludes amortization expenses, income from continuing operations was $30.9 million, or $0.84 per diluted share for the second quarter 2011. (Please see attached reconciliation page.)  This is compared to reported revenues of $255.5 million and adjusted cash basis income from continuing operations of $25.1 million, or $0.71 per diluted share for the same period in 2010.  


For the six months ended June 30, 2011, the Company reported total revenues of $457.1 million and a loss of $99.7 million from continuing operations, or $2.79 per diluted share, as a result of a $190.6 million pre-tax litigation settlement expense in the first quarter and the aforementioned restructuring and tax charges in the second quarter.  On an adjusted cash basis (non-GAAP measure), income from continuing operations was $65.9 million, or $1.80 per diluted share.  This compares to reported revenues of $547.4 million and income from continuing operations of $44.5 million, or $1.26 diluted share, for the same period in 2010.  On an adjusted cash basis, income from continuing operations for the first six months of 2010 was $51.4 million, or $1.46 per diluted share.


The following is a product level discussion of second quarter 2011 results versus the first quarter 2011:




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Key Product Sales

Metoprolol:  For the quarter ended June 30, 2011, net sales of metoprolol succinate were $63.7 million compared to net sales of $63.4 million in the first quarter 2011. Par Pharmaceutical, the Company’s generic drug division, is the authorized generic for all strengths of AstraZeneca’s Toprol XL®.

Budesonide EC:  Net sales for budesonide EC in the second quarter were $16.4 million.  Par Pharmaceutical launched the product in the second quarter as the authorized generic for AstraZenecas Entocort® EC.

Sumatriptan: Net sales of sumatriptan succinate were $15.3 million in the second quarter 2011 compared to $16.7 million in the first quarter 2011.  Par Pharmaceutical remained the exclusive supplier of generic Imitrex® 4mg and 6mg starter kits and 4mg prefilled cartridges and had one competitor in the 6mg prefilled cartridges throughout the second quarter.

Propafenone Hydrochloride ER: Net sales for Propafenone Hydrochloride ER in the second quarter were $13.3 million compared to $22.0 million in the first quarter.  The decrease was driven by customers non-recurrence of first quarter launch quantities.  Par Pharmaceutical remained the exclusive supplier of generic Rythmol SR® throughout the second quarter.

Amlodipine and Benazepril: Net sales for the second quarter 2011 were $12.5 million compared to $18.2 million in the first quarter.  The decrease was driven by customers non-recurrence of first quarter launch quantities.

Meclizine: Net sales for the second quarter were $4.6 million compared to $4.9 million in the previous quarter.  The decrease was driven by customer buying patterns.

Other Generic Products: For the second quarter 2011, net sales from all other generic products were $76.7 million. This compares to net sales of $84.5 million in the first quarter 2011. The decrease is due to primarily to the voluntary withdrawal of clonidine in the second quarter and the seasonality of hydrocodone/chlorpheniramine.

Megace® ES: Net sales were $14.1 million for the second quarter compared to $14.1 million in the first quarter.

Nascobal® B12 Nasal Spray: Net sales were $6.3 million for the second quarter compared to $3.9 million in the first quarter.  The increase was due, in part, to a shortage of a competing vitamin B12 intramuscular injection product.

Revenues and gross margin for the second quarter 2011 were $224.2 million and $99.0 million, respectively, compared to $233.0 million in net sales and $109.7 million in gross margin during the prior quarter (Q1 2011). The gross margin rate on the Company’s consolidated product portfolio decreased to 44.2% versus 47.1% in the first quarter 2011.  The decrease was due primarily to the non-recurrence of the first quarter launches of propafenone and amlodipine/benazepril and the second quarter launch of lower margin budesonide.  



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2Q 2011

 

1Q 2011

 

 

$

%

 

$

%

Key Par (Generic) Products (1)(2)

 

 $   40.7

32.3%

 

 $   50.6

40.4%

 

 

 

 

 

 

 

All other Par (Generic)

 

      43.3

56.5%

 

     42.0

49.6%

 

 

 

 

 

 

 

Total Par (Generic)

 

 $   84.0

41.5%

 

 $   92.6

44.1%

 

 

 

 

 

 

 

Strativa (Branded) Products

 

 $   15.0

69.1%

 

 $   17.1

73.7%

 

 

 

 

 

 

 

Total (All Products)

 

 $   99.0

44.2%

 

 $ 109.7

47.1%

 

 

 

 

 

 

 

1.

Q211 Key Par Products is comprised of Metoprolol, Budesonide EC, Sumatriptan, Propafenone, Amlodipine/benazapril, Meclizine.

2.

Q111 Key Par Products does not include Budesonide EC as it was launched in Q2.


Operating Expenses

Excluding the one-time restructuring charge of $27.7 million, total operating expenses decreased during the second quarter of 2011 as compared to the prior quarter as follows:


·

Research and development expenses were $8.1 million in the second quarter of 2011 compared to $10.7 million in the first quarter.  The decrease was due to lower generic development costs.


·

Selling, general and administrative expenses for the second quarter 2011 decreased to $46.2 million compared to $46.9 million in the first quarter of 2011.  The decrease reflects lower employment costs.


Cash and cash equivalents and marketable securities

The aggregate balance as of June 30, 2011 was approximately $346 million.


Product and Pipeline Update

In July, Strativa Pharmaceuticals returned the U.S. commercialization rights of Zuplenz® to its development partner, MonoSol Rx, as part of the branded division’s restructuring announced in June.


In July, the Company received a notice letter from a generic pharmaceutical manufacturer, advising that it has filed an Abbreviated New Drug Application with the U.S. FDA containing a Paragraph IV certification referencing Megace® ES.   Megace® ES is protected by Elan Pharma International Limited’s U.S. Patents 6,592,903 and 7,101,576.  The Company intends, with Elan, to investigate the Paragraph IV certification and ANDA, and to enforce its patents, which expire in 2020 and 2024, respectively, as appropriate.


Par Pharmaceutical, along with third-party partners, currently has approximately 31 ANDAs pending with the FDA, 13 of which it believes to be first-to-file opportunities.







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Conference Call

 

Access to the live webcast can be made via the Company's website at www.parpharm.com.


Dial-in Information

Domestic:

866-362-4832

International:

617-597-5364

Passcode:

55151925


A replay of the conference call will be available for two weeks approximately one hour after the call.  

Replay Information

Domestic:

888-286-8010

International:

617-801-6888

Passcode:

90475213


Non-GAAP Measures

Par Pharmaceutical Companies, Inc. (“the Company”) believes it prepared its unaudited condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP) and pursuant to accounting requirements of the Securities and Exchange Commission.  In an effort to provide investors with additional information regarding the Company’s results and to provide a meaningful period-over-period comparison of the Company’s financial performance, the Company sometimes uses non-GAAP financial measures as defined by the Securities and Exchange Commission.  The differences between the U.S. GAAP and non-GAAP financial measures are reconciled in an attached schedule.  In presenting comparable results, the Company discloses non-GAAP financial measures when it believes such measures will be useful to investors in evaluating the Company’s underlying business performance.  Management uses the non-GAAP financial measures to evaluate the Company’s financial performance against internal budgets and targets.  In addition, management internally reviews the Company’s results excluding the impact of certain items, as it believes that these non-GAAP financial measures are useful for evaluating the Company’s core operating results and facilitating comparison across reporting periods.  Importantly, the Company believes non-GAAP financial measures should be considered in addition to, and not in lieu of, U.S. GAAP financial measures.  The Company’s non-GAAP financial measures may be different from non-GAAP financial measures used by other companies.


About Par Pharmaceutical Companies, Inc.

Par Pharmaceutical Companies, Inc. is a US-based specialty pharmaceutical company.  Through its wholly-owned subsidiary’s two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets higher-barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals. For press release and other company information, visit www.parpharm.com.



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Safe Harbor Statement

Certain statements in this news release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.  To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and, as such, are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein.  Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company’s most recent Annual Report on Form 10-K, in other of the Company’s filings with the SEC from time to time, including Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and on general industry and economic conditions.  Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.


# # #



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PAR PHARMACEUTICAL COMPANIES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In Thousands, Except Per Share Data)

(Unaudited)


 

Three months ended

 

Six months ended

 

June 30,

 

June 30,

 

June 30,

 

June 30,

 

2011

 

2010

 

2011

 

2010

Revenues:

 

 

 

 

 

 

 

    Net product sales

$215,018

 

$248,739

 

$435,807

 

$537,017

    Other product related revenues

9,170

 

6,735

 

21,333

 

10,389

Total revenues

224,188

 

255,474

 

457,140

 

547,406

Cost of goods sold

125,162

 

164,015

 

248,461

 

372,437

    Gross margin

99,026

 

91,459

 

208,679

 

174,969

Operating expenses:

 

 

 

 

 

 

 

    Research and development

8,077

 

22,660

 

18,787

 

27,312

    Selling, general and administrative

46,156

 

48,865

 

93,101

 

90,100

    Settlements and loss contingencies, net

-

 

(4,068)

 

190,560

 

(4,006)

    Restructuring costs

26,986

 

-

 

26,986

 

-

Total operating expenses

81,219

 

67,457

 

329,434

 

113,406

Gain on sale of product rights and other

 -

 

146

 

 -

 

5,921

Operating (loss) income

17,807

 

24,148

 

(120,755)

 

67,484

Interest income

382

 

273

 

805

 

601

Interest expense

(150)

 

(918)

 

(301)

 

(1,826)

Income (loss) from continuing operations before provision
    for income taxes

18,039

 

23,503

 

(120,251)

 

66,259

Provision (benefit) for income taxes

8,859

 

5,468

 

(20,587)

 

21,798

Income (loss) from continuing operations

9,180

 

18,035

 

(99,664)

 

44,461

Discontinued operations:

 

 

 

 

 

 

 

Provision (benefit) for income taxes

127

 

(360)

 

253

 

(232)

(Loss) income from discontinued operations

(127)

 

360

 

(253)

 

232

Net income (loss)

$9,053

 

$18,395

 

($99,917)

 

$44,693

 

 

 

 

 

 

 

 

Basic earnings (loss) per share of common stock:

 

 

 

 

 

 

 

Income (loss) from continuing operations

$0.26

 

$0.53

 

($2.79)

 

$1.31

(Loss) income from discontinued operations

(0.01)

 

0.01

 

(0.01)

 

0.01

Net income (loss)  

$0.25

 

$0.54

 

($2.80)

 

$1.32

 

 

 

 

 

 

 

 

Diluted earnings (loss) per share of common stock:

 

 

 

 

 

 

 

Income (loss) from continuing operations

$0.25

 

$0.51

 

($2.79)

 

$1.26

(Loss) income from discontinued operations

(0.00)

 

0.01

 

(0.01)

 

0.01

Net income (loss)  

$0.25

 

$0.52

 

($2.80)

 

$1.27

 

 

 

 

 

 

 

 

Weighted average number of common shares outstanding:

 

 

 

 

 

 

 

  Basic

35,983

 

34,112

 

35,742

 

34,021

  Diluted

36,708

 

35,475

 

35,742

 

35,273

 

 

June 30,

 

December 31,

 

 

2011

 

2010

      ASSETS

 

 

 

 

Current assets:

 

 

 

 

    Cash and cash equivalents

 

$307,011

 

$218,674

    Available for sale marketable debt securities

 

38,652

 

27,866

    Accounts receivable, net  

 

122,630

 

95,705

    Inventories

 

75,353

 

72,580

    Prepaid expenses and other current assets

 

14,338

 

17,660

    Deferred income tax assets

 

30,009

 

26,037

    Income taxes receivable

 

63,328

 

18,605

    Total current assets

 

651,321

 

477,127

 

 

 

 

 

Property, plant and equipment, net

 

71,117

 

71,980

Intangible assets, net

 

65,573

 

95,467

Goodwill

 

63,729

 

63,729

Other assets

 

6,624

 

5,441

Non-current deferred income tax assets, net

 

56,395

 

69,488

Total assets

 

$914,759

 

$783,232

 

 

 

 

 

      LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

Current liabilities:

 

 

 

 

    Accounts payable

 

$27,381

 

$23,956

    Payables due to distribution agreement partners

 

50,435

 

25,310

    Accrued salaries and employee benefits

 

10,401

 

16,397

    Accrued government pricing liabilities

 

32,148

 

32,169

    Accrued legal fees

 

8,604

 

7,084

    Accrued legal settlements

 

195,400

 

-

    Accrued expenses and other current liabilities

 

8,277

 

6,674

    Total current liabilities

 

332,646

 

111,590

 

 

 

 

 

Long-term liabilities

 

42,810

 

43,198

Commitments and contingencies

 

-

 

-

 

 

 

 

 

Stockholders' equity:

 

 

 

 

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

 

 

 

 

         39,655,227 and 38,872,663 shares

 

394

 

389

    Additional paid-in capital

 

391,664

 

373,764

    Retained earnings

 

229,212

 

329,129

    Accumulated other comprehensive gain

 

68

 

137

    Treasury stock, at cost 3,170,185 and 2,970,573 shares

 

(82,035)

 

(74,975)

    Total stockholders' equity

 

539,303

 

628,444

Total liabilities and stockholders’ equity

 

$914,759

 

$783,232





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Reconciliation Between Reported (GAAP); Adjusted Income (Loss) from Continuing Operations and “Cash EPS”

(In Thousands, Except Per Share Data)

(Unaudited)

 

 

 

Three Months Ended

 

June 30,

 

June 30,

 

2011

 

2010

Income from Continuing Operations

$9,180

 

$18,035

 

 

 

 

Restructuring costs

27,660

 

-

Upfront and development milestone payments

-

 

17,000

Litigation settlements and contingencies

-

 

(4,130)

Non-cash interest expense

-

 

524

Sum of adjustments, pre-tax

$27,660

 

$13,394

Estimated tax on adjustments

(10,234)

 

(5,090)

Charge related to valuation of deferred income tax assets

2,391

 

-

Resolution of tax contingencies

-

 

(3,657)

Adjusted Income from Continuing Operations (non-GAAP measure)

$28,997

 

$22,682

 

 

 

 

Amortization Expense

3,013

 

3,904

    Estimated tax impact

(1,115)

 

(1,484)

Amortization Expense, net of tax

1,898

 

2,420

    Adjusted Cash basis from Continuing Operations (non-GAAP measure)

30,895

 

25,102

    “Cash EPS” from Continuing Operations (non-GAAP measure)

$0.84

 

$0.71

 

 

 

 

Diluted weighted average shares outstanding

36,708

 

35,475


 

 

 

 

 

Six Months Ended

 

June 30,

 

June 30,

 

2011

 

2010

(Loss) Income from Continuing Operations

($99,664)

 

$44,461

 

 

 

 

Litigation settlements and contingencies, pre-tax

190,560

 

(4,130)

Restructuring costs

27,660

 

-

Upfront and development milestone payments

-

 

17,000

Sale of product rights

-

 

(5,000)

Non-cash interest expense

-

 

1,038

Sum of adjustments, pre-tax

$218,220

 

$8,908

Estimated tax on adjustments

(58,909)

 

(3,385)

Charge related to valuation of deferred income tax assets

2,391

 

-

Resolution of tax contingencies

-

 

(3,657)

Adjusted Income from Continuing Operations (non-GAAP measure)

$62,038

 

$46,327

 

 

 

 

Amortization Expense

6,118

 

8,154

    Estimated tax impact

(2,295)

 

(3,099)

Amortization Expense, net of tax

3,823

 

5,055

    Adjusted Cash basis from Continuing Operations (non-GAAP measure)

65,861

 

51,382

    “Cash EPS” from Continuing Operations (non-GAAP measure)

$1.80

 

$1.46

 

 

 

 

Diluted weighted average shares outstanding

36,555

 

35,273




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