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8-K - FORM 8-K - PAR PHARMACEUTICAL COMPANIES, INC.form8kearningsq32011.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

THIRD QUARTER 2011 RESULTS


Reports Adjusted Cash EPS of $0.74


Strong Performance of Key Generic Products


Continued Robust Cash Generation



Woodcliff Lake, N.J., November 2, 2011 – Par Pharmaceutical Companies, Inc. (NYSE:PRX) today reported results for the third quarter ended September 30, 2011.


For the third quarter ended September 30, 2011, the Company reported total revenues of $215.4 million, and income from continuing operations of $22.1 million, or $0.60 per diluted share, which includes $2.9 million of acquisition-related expenses.  Excluding this item and associated tax impacts, adjusted income from continuing operations (non-GAAP measure) was $25.5 million. On an adjusted cash basis (non-GAAP measure), which excludes amortization expenses, income from continuing operations was $27.1 million, or $0.74 per diluted share for the third quarter 2011. (Please see attached reconciliation page.)  This is compared to reported revenues of $234.4 million and adjusted cash basis income from continuing operations of $31.3 million, or $0.88 per diluted share for the same period in 2010.


For the nine months ended September 30, 2011, the Company reported total revenues of $672.5 million and a loss of $77.6 million from continuing operations, or $2.17 per diluted share, as a result of a $190.6 million pre-tax litigation settlement expense in the first quarter, second quarter restructuring charges of $27.7 million, and the aforementioned transaction costs.  On an adjusted cash basis (non-GAAP measure), income from continuing operations was $92.9 million, or $2.54 per diluted share.  This compares to reported revenues of $781.8 million and income from continuing operations of $75.1 million, or $2.12 diluted share, for the same period in 2010.  On an adjusted cash basis, income from continuing operations for the first nine months of 2010 was $82.7 million, or $2.34 per diluted share.


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



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Key Product Sales

·

Metoprolol:  For the quarter ended September 30, 2011, net sales of metoprolol succinate were $67.5 million compared to net sales of $63.7 million in the second quarter 2011.  The increase was due to customer buying patterns.  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 third quarter were $20.6 million compared to $16.4 million in the second quarter, when the product was launched.  Par Pharmaceutical is the authorized generic for AstraZeneca’s Entocort® EC.

·

Sumatriptan: Net sales of sumatriptan succinate were $16.8 million in the third quarter 2011 compared to $15.3 million in the second quarter 2011.  The increase was due to customer buying patterns.

·

Propafenone Hydrochloride ER: Net sales for Propafenone Hydrochloride ER in the third quarter were $18.1 million compared to $13.3 million in the second quarter.  The increase was driven by customer buying patterns following the first quarter 2011 launch of the product.  Par Pharmaceutical remained the exclusive supplier of generic Rythmol SR® throughout the third quarter.

·

Amlodipine and Benazepril: Net sales for the third quarter 2011 were $4.5 million compared to $12.5 million in the second quarter.  The decrease was driven by price and volume declines due to additional competition in the third quarter.

·

Meclizine: Net sales for the third quarter were $3.9 million compared to $4.6 million in the previous quarter.  The decrease was driven by price and volume declines due to additional competition in the third quarter.

·

Other Generic Products: For the third quarter 2011, net sales from all other generic products were $64.2 million. This compares to net sales of $76.7 million in the second quarter 2011. The decrease is due to customer buying patterns and a decrease in royalty income.

·

Megace® ES: Net sales were $14.2 million for the third quarter compared to $14.1 million in the second quarter.

·

Nascobal® B12 Nasal Spray: Net sales were $4.7 million for the third quarter compared to $6.3 million in the second quarter.  The decrease was due to primarily to increases in Medicaid rebates.


Revenues and gross margin for the third quarter 2011 were $215.4 million and $85.1 million, respectively, compared to $224.2 million in net sales and $99 million in gross margin during the prior quarter (Q2 2011). The gross margin rate on the Company’s consolidated product portfolio decreased to 39.5% versus 44.2% in the second quarter 2011.  The decrease was due primarily to lower royalty income, a decrease in price and volume of amlodipine/benazepril, and an increase in sales of lower-margin budesonide EC.



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3Q 2011

 

2Q 2011

 

 

$

%

 

$

%

Key Par (Generic) Products (1)

 

 $   37.1

28.3%

 

 $   40.7

32.3%

 

 

 

 

 

 

 

All other Par (Generic)

 

      34.5

53.8%

 

     43.3

56.5%

 

 

 

 

 

 

 

Total Par (Generic)

 

 $   71.6

36.7%

 

 $   84.0

41.5%

 

 

 

 

 

 

 

Strativa (Branded) Products

 

 $   13.5

67.6%

 

 $   15.0

69.1%

 

 

 

 

 

 

 

Total (All Products)

 

 $   85.1

39.5%

 

 $   99.0

44.2%

 

 

 

 

 

 

 

1.

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


Operating Expenses

On a GAAP basis, total operating expenses decreased during the third quarter of 2011 as compared to the prior quarter as follows:


·

Research and development expenses were $9.6 million in the third quarter of 2011 compared to $8.1 million in the second quarter.  The increase was due to higher generic development activity.


·

Selling, general and administrative expenses for the third quarter 2011 decreased to $35.8 million compared to $46.2 million in the second quarter of 2011.  The decrease reflects lower costs as a result of the second quarter branded division restructuring, as well as lower legal and share-based compensation expenses.


Cash and cash equivalents and marketable securities

The aggregate balance as of September 30, 2011 was approximately $256.8 million, after $157.6 million in payments during the quarter for previously announced AWP litigation settlements.


Product and Pipeline Update

In August, Par Pharmaceutical Companies entered into a definitive agreement to acquire Anchen Pharmaceuticals, a privately-held specialty pharmaceutical company focused on developing and commercializing extended release and niche generic products, for $410 million in cash.  The transaction is expected to close by year-end.


In October, Par Pharmaceutical acquired rights to three products from Teva Pharmaceuticals in connection with Teva’s acquisition of Cephalon.  Par now owns the ANDAs of fentanyl citrate lozenges, a generic version of Actiq®, and cyclobenzaprine ER capsules, the generic version of Amrix®, as well as the U.S. rights to market modafinil tablets, the generic version of Provigil®.  Par is currently shipping to the trade all strengths of fentanyl citrate lozenges that were previously available from Teva.


In October, Par Pharmaceutical began shipping all strengths of olanzapine orally disintegrating tablets, the generic version of Lilly’s Zyprexa Zydis®.  According to IMS Health data, annual sales in the U.S. of Zyprexa Zydis are approximately $360 million.




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Par Pharmaceutical, along with third-party partners, currently has approximately 32 ANDAs pending with the FDA, 13 of which it believes to be first-to-file opportunities.



Conference Call

The Company will host a conference call and live webcast today, Wednesday, November 2, 2011 at 9:00 AM EDT to review results for the third quarter 2011.  Access to the live webcast can be made via the Company's website at www.parpharm.com.


Dial-in Information

Domestic:

800-901-5241

International:

617-786-2963

Passcode:

52087832


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:

42213272



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 BALANCE SHEETS

(In Thousands, Except Share Data)

(Unaudited)

 

 

September 30,

 

December 31,

 

 

2011

 

2010

      ASSETS

 

 

 

 

Current assets:

 

 

 

 

    Cash and cash equivalents

 

$

225,969 

 

$

218,674 

    Available for sale marketable debt securities

 

30,861 

 

27,866 

    Accounts receivable, net  

 

98,103 

 

95,705 

    Inventories

 

80,986 

 

72,580 

    Prepaid expenses and other current assets

 

22,537 

 

17,660 

    Deferred income tax assets

 

31,005 

 

26,037 

    Income taxes receivable

 

37,864 

 

18,605 

    Total current assets

 

527,325 

 

477,127 

 

 

 

 

 

Property, plant and equipment, net

 

69,665 

 

71,980 

Intangible assets, net

 

63,424 

 

95,467 

Goodwill

 

63,729 

 

63,729 

Other assets

 

6,495 

 

5,441 

Non-current deferred income tax assets, net

 

55,451 

 

69,488 

Total assets

 

$

786,089 

 

$

783,232 

 

 

 

 

 

      LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

Current liabilities:

 

 

 

 

    Accounts payable

 

$

21,551 

 

$

23,956 

    Payables due to distribution agreement partners

 

53,473 

 

25,310 

    Accrued salaries and employee benefits

 

11,660 

 

16,397 

    Accrued government pricing liabilities

 

39,824 

 

32,169 

    Accrued legal fees

 

7,296 

 

7,084 

    Accrued legal settlements

 

37,800 

 

    Accrued expenses and other current liabilities

 

6,056 

 

6,674 

    Total current liabilities

 

177,660 

 

111,590 

 

 

 

 

 

Long-term liabilities

 

44,791 

 

43,198 

Commitments and contingencies

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

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

 

 

 

 

         39,662,618 and 38,872,663 shares

 

394 

 

389 

    Additional paid-in capital

 

394,468 

 

373,764 

    Retained earnings

 

251,140 

 

329,129 

    Accumulated other comprehensive (loss) income

 

(21)

 

137 

    Treasury stock, at cost 3,180,643 and 2,970,573 shares

 

(82,343)

 

(74,975)

    Total stockholders' equity

 

563,638 

 

628,444 

Total liabilities and stockholders’ equity

 

$

786,089 

 

$

783,232 

 



- 6 -




PAR PHARMACEUTICAL COMPANIES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In Thousands, Except Per Share Data)

(Unaudited)


 

Three months ended

 

Nine months ended

 

September 30,

 

September 30,

 

September 30,

 

September 30,

 

2011

 

2010

 

2011

 

2010

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

    Net product sales

$

208,865 

 

$

226,131 

 

$

644,672 

 

$

763,148 

    Other product related revenues

6,492 

 

8,309 

 

27,825 

 

18,698 

Total revenues

215,357 

 

234,440 

 

672,497 

 

781,846 

Cost of goods sold

130,253 

 

131,146 

 

378,714 

 

503,583 

    Gross margin

85,104 

 

103,294 

 

293,783 

 

278,263 

Operating expenses:

 

 

 

 

 

 

 

    Research and development

9,610 

 

10,145 

 

28,397 

 

37,457 

    Selling, general and administrative

35,762 

 

50,302 

 

128,863 

 

140,402 

    Settlements and loss contingencies, net

 

2,312 

 

190,560 

 

(1,694)

    Restructuring costs

 

 

26,986 

 

Total operating expenses

45,372 

 

62,759 

 

374,806 

 

176,165 

Gain on sale of product rights and other

 

79 

 

 

6,000 

Operating income (loss)

39,732 

 

40,614 

 

(81,023)

 

108,098 

Gain on marketable securities and other
    investments, net

 

3,567 

 

 

3,567 

Interest income

160 

 

341 

 

965 

 

942 

Interest expense

(150)

 

(928)

 

(451)

 

(2,754)

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

39,742 

 

43,594 

 

(80,509)

 

109,853 

Provision (benefit) for income taxes

17,687 

 

12,933 

 

(2,900)

 

34,731 

Income (loss) from continuing operations

22,055 

 

30,661 

 

(77,609)

 

75,122 

Discontinued operations:

 

 

 

 

 

 

 

Provision (benefit) for income taxes

127 

 

127 

 

380 

 

(105)

(Loss) income from discontinued operations

(127)

 

(127)

 

(380)

 

105 

Net income (loss)

$

21,928 

 

$

30,534 

 

($77,989)

 

$

75,227 

 

 

 

 

 

 

 

 

Basic earnings (loss) per share of common stock:

 

 

 

 

 

 

 

Income (loss) from continuing operations

$

0.61 

 

$

0.89 

 

($2.16)

 

$

2.20 

(Loss) income from discontinued operations

(0.00)

 

(0.00)

 

(0.01)

 

0.00 

Net income (loss)  

$

0.61 

 

$

0.89 

 

($2.17)

 

$

2.20 

 

 

 

 

 

 

 

 

Diluted earnings (loss) per share of common stock:

 

 

 

 

 

 

 

Income (loss) from continuing operations

$

0.60 

 

$

0.86 

 

($2.16)

 

$

2.12 

(Loss) income from discontinued operations

(0.00)

 

(0.00)

 

(0.01)

 

0.00 

Net income (loss)  

$

0.60 

 

$

0.86 

 

($2.17)

 

$

2.12 

 

 

 

 

 

 

 

 

Weighted average number of common shares
    outstanding:

 

 

 

 

 

 

 

  Basic

36,143 

 

34,310 

 

35,875 

 

34,117 

  Diluted

36,774 

 

35,684 

 

35,875 

 

35,410 



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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

 

September 30,

 

September 30,

 

2011

 

2010

Income from Continuing Operations

$

22,055 

 

$

30,661 

 

 

 

 

Transaction costs for Edict and Anchen

2,852 

 

Upfront and development milestone payments

 

2,000 

Litigation settlements and contingencies

 

2,250 

Non-cash interest expense

 

533 

Abrika earn-out payment

 

(3,567)

Sum of adjustments, pre-tax

$

2,852 

 

$

1,216 

Estimated tax on adjustments

551 

 

(462)

Domestic manufacturing tax benefit

 

(2,009)

Adjusted Income from Continuing Operations (non-GAAP measure)

$

25,458 

 

$

29,406 

 

 

 

 

Amortization Expense

2,548 

 

3,079 

    Estimated tax impact

(943)

 

(1,170)

Amortization Expense, net of tax

1,605 

 

1,909 

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

27,063 

 

31,315 

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

$

0.74 

 

$

0.88 

 

 

 

 

Diluted weighted average shares outstanding

36,774 

 

35,684 


 

Nine Months Ended

 

September 30,

 

September 30,

 

2011

 

2010

(Loss) Income from Continuing Operations

($77,609)

 

$

75,122 

 

 

 

 

Litigation settlements and contingencies, pre-tax

190,560 

 

(1,880)

Restructuring costs

27,660 

 

Transaction costs for Edict and Anchen

2,852 

 

Upfront and development milestone payments

 

19,000 

Sale of product rights

 

(5,000)

Non-cash interest expense

 

1,571 

Abrika earn-out payment

 

(3,567)

Sum of adjustments, pre-tax

$

221,072 

 

$

10,124 

Estimated tax on adjustments

(58,397)

 

(3,847)

Charge related to valuation of deferred income tax assets

2,391 

 

Resolution of tax contingencies

 

(3,657)

Domestic manufacturing tax benefit

 

(2,009)

Adjusted Income from Continuing Operations (non-GAAP measure)

$

87,457 

 

$

75,733 

 

 

 

 

Amortization Expense

8,666 

 

11,233 

    Estimated tax impact

(3,238)

 

(4,269)

Amortization Expense, net of tax

5,428 

 

6,964 

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

92,885 

 

82,697 

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

$

2.54 

 

$

2.34 

 

 

 

 

Diluted weighted average shares outstanding

36,525 

 

35,410 




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