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8-K - FORM 8-K - PAR PHARMACEUTICAL COMPANIES, INC.form8kearningsq12011.htm

 


Contact:

Allison Wey

Vice President, Investor Relations and Corporate Affairs

Par Pharmaceutical Companies, Inc.

(201) 802-4000



PAR PHARMACEUTICAL COMPANIES REPORTS

FIRST QUARTER 2011 RESULTS


Reports Adjusted Cash EPS of $0.96

Achieves Record Quarterly Gross Margin of $109.7 Million

Pre-tax Litigation Settlement Charge of $190.6 Million Results in GAAP Loss of $3.07 per Share



Woodcliff Lake, N.J., May 5, 2011 – Par Pharmaceutical Companies, Inc. (NYSE:PRX) today reported results for the first quarter ended March 31, 2011.


For the first quarter ended March 31, 2011, the Company reported total revenues of $233.0 million and gross margin of $109.7 million. There was a net loss from continuing operations of $108.8 million, or $3.07 per share, resulting from pre-tax litigation settlement expenses of $190.6 million. Excluding this item, adjusted income from continuing operations (non-GAAP measure) was $33.0 million. On an adjusted cash basis (non-GAAP measure), which excludes amortization expenses, income from continuing operations was $34.9 million, or $0.96 per diluted share for the first quarter 2011 (please see attached supplement).  This is compared to reported revenues of $291.9 million and adjusted cash basis income from continuing operations of $26.3 million, or $0.75 per diluted share for the same period in 2010, which included several one-time items.  


First quarter 2011 revenues and gross margin of $233.0 million and $109.7 million, respectively, increased from the $227.0 million in net sales and $95.3 million in gross margin during the prior quarter (Q4 2010). The gross margin rate on the Company’s consolidated product portfolio increased to 47.1% versus 42.0% in the fourth quarter 2010.


The following is a product level discussion of first quarter 2011 results versus the fourth quarter 2010:

Key Product Sales

·

Metoprolol:  For the quarter ended March 31, 2011, net sales of metoprolol succinate were $63.4 million compared to net sales of $73.0 million in the fourth quarter 2010.  The decrease was driven by customer buying patterns.  Par Pharmaceutical, the Company’s generic drug division, is the authorized generic for all strengths of AstraZeneca’s Toprol XL®.



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·

Propafenone Hydrochloride ER: Net sales for Propafenone Hydrochloride ER in the first quarter were $22.0 million. Par Pharmaceutical launched the product in the first quarter 2011 and remains the exclusive supplier of generic Rythmol SR®.


·

Amlodipine and Benazepril: Net sales for the first quarter 2011 were $18.2 million.  Par Pharmaceutical launched the product in the first quarter 2011.


·

Sumatriptan: Net sales of sumatriptan succinate were $16.7 million in the first quarter 2011 compared to $19.9 million in the fourth quarter 2010.  The decrease was due to customer buying patterns.  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 first quarter.


·

Meclizine: Net sales for first quarter were $4.9 million compared to $5.4 million in the previous quarter.  The decrease was driven by customer buying patterns.


·

Other Generic Products: For the first quarter 2011, net revenues from all other generic products were $84.5 million. This compares to net sales of $104.9 million in the fourth quarter 2010.  The decrease is due to the seasonality of hydrocodone/chlorpheniramine, lower clonidine, as well as several non-recurring events that occurred in the fourth quarter. Adjusting for these events, Par experienced no erosion to Other Generic Products.


·

Megace® ES: Net sales were $14.1 million for the first quarter compared to $14.8 million in the fourth quarter 2010.


·

Nascobal® B12 Nasal Spray: Net sales were $3.9 million for the three months ended March 31, 2011 compared to $4.8 million in the fourth quarter 2010.



Gross margin for the first quarter 2011 increased 15.1% compared to the fourth quarter 2010 due primarily to the first quarter launches of propafenone and amlodipine/benazepril.  These gains were partially offset by lower metroprolol, sumatriptan, meclizine, and other generic product sales, as well a $2.4 million impact of U.S. healthcare reform.


 

 

 

1Q 2011

 

4Q 2010

 

 

 

 

 

$

%

 

$

%

 

 

 

Key Par (Generic) Products (1)

 

 $   50.6

40.4%

 

 $   26.4

27.2%

 

 

 

 

 

 

 

 

 

 

 

 

 

All other Par (Generic)

 

      42.0

49.6%

 

     52.5

49.8%

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Par (Generic)

 

 $   92.6

44.1%

 

 $   78.9

38.8%

 

 

 

 

 

 

 

 

 

 

 

 

 

Strativa (Branded) Products

 

 $   17.1

73.7%

 

 $   16.4

68.6%

 

 

 

 

 

 

 

 

 

 

 

 

 

Total (All Products)

 

 $ 109.7

47.1%

 

 $   95.3

42.0%

 

 

 

 

 

 

 

 

 

 

 

 




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Operating Expenses

Net of the aforementioned litigation settlement expense (discussed in greater detail below), total operating expenses declined by 16% during the first quarter of 2011 as compared to the prior quarter as follows:


Research and development expenses were $10.7 million in the first quarter of 2011 compared to $12.9 million in the fourth quarter 2010.  The decrease was due to lower development costs.


Selling, general and administrative expenses for the first quarter 2011 decreased to $47.0 million compared to $52.1 million in the fourth quarter of 2010.  The decrease reflects lower expenditures of Strativa sales and marketing tempered by higher legal fees.


Settlements and loss contingencies expense

During the quarter the Company recorded a charge of $190.6 million related to a settlement in principle 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 $154.0 million and with the State of Idaho for $1.7 million .  The balance of the $190.6 million charge is an accrual for estimated potential exposure for the remaining AWP matters .  


Cash and cash equivalents and marketable securities

The aggregate balance as of March 31, 2011 was $284.5 million.


Product and Pipeline Update

In the first quarter 2011, the Company earned $4.3 million of royalty income resulting from Optimer Pharmaceuticals’ sale of certain rights in fidaxomicin to a third party.  Under the terms of the 2007 termination agreement, the Company is also entitled to royalty payments on future sales of fidaxomicin.


In April 2011, Par voluntarily discontinued shipment of all strengths of clonidine while its partner, Aveva, implements manufacturing process improvements.  


In April, Par Pharmaceutical out-licensed the marketing and distribution rights of omeprazole sodium bicarbonate OTC capsules to PL Developments, a leading manufacturer and packager of store brand over-the-counter products.  Par Pharmaceutical will receive milestone payments upon certain events and a share of the profits.  


Par Pharmaceutical, along with third-party partners, currently has approximately 30 ANDAs pending with the FDA, 12 of which it believes to be first-to-file opportunities.



Conference Call

Par Pharmaceutical Companies, Inc. (NYSE:PRX) announced today that it will host a conference call and live webcast on Thursday, May 5, 2011 at 9:00 AM ET to review results for the first quarter 2011.  The Company will release its financial results on May 5, 2011 before the market opens.



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

 

Dial-in Information


Domestic:

866-272-9941

International:

617-213-8895

Passcode:

31861139


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:

34043387

 

 

Non-GAAP Measures

Par Pharmaceutical Companies, Inc. (“the Company”) believes it prepared its 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

 

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 


.



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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 



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

(In Thousands, Except Per Share Data)

(Unaudited)

 

 

 

 

 

Three Months Ended

 

March 31,

 

March 31,

 

2011

 

2010

(Loss) Income from Continuing Operations

($108,844)

 

$

26,426 

 

 

 

 

Litigation settlements and contingencies

190,560 

 

Sale of product rights

 

(5,000)

Non-cash interest expense

 

514 

Sum of adjustments, pre-tax

$

190,560 

 

($4,486)

Estimated tax on adjustments

(48,714)

 

1,705 

Adjusted Income from Continuing Operations (non-GAAP measure)

$

33,002 

 

$

23,645 

 

 

 

 

Amortization Expense

3,105 

 

4,250 

    Estimated tax impact

(1,180)

 

(1,615)

Amortization Expense, net of tax

1,925 

 

2,635 

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

34,927 

 

26,280 

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

$

0.96 

 

$

0.75 

 

 

 

 

Diluted weighted average shares outstanding

36,402 

 

35,070 

 

 

 

 


 

 

 

 

 

Three Months Ended

 

March 31,

 

December 31,

 

2011 

 

2010 

(Loss) Income from Continuing Operations

($108,844)

 

$

17,630 

 

 

 

 

Litigation settlements and contingencies, pre-tax

190,560 

 

2,741 

Estimated tax on adjustments

(48,714)

 

(1,042)

Adjusted Income from Continuing Operations (non-GAAP measure)

$

33,002 

 

$

19,329 

 

 

 

 

Amortization Expense

3,105 

 

4,772 

    Estimated tax impact

(1,180)

 

(1,813)

Amortization Expense, net of tax

1,925 

 

2,959 

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

34,927 

 

22,288 

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

$

0.96 

 

$

0.61 

 

 

 

 

Diluted weighted average shares outstanding

36,402 

 

36,345 




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