EX-99.1 2 f8410q22010earningsresults.htm EARNINGS PRESS RELEASE _



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Contact:

Allison Wey

Investor Relations and Corporate Affairs

Par Pharmaceutical Companies, Inc.

(201) 802-4000



PAR PHARMACEUTICAL COMPANIES REPORTS SECOND QUARTER 2010 RESULTS


- Reports GAAP EPS of $0.51; Adjusted Cash EPS of $0.71 -

 - Achieves Near-record Quarterly Gross Margin of $91.5 Million -

- Makes Significant Investments in Generic Development Opportunities –

- Prepares to Launch Two Branded Products -



Woodcliff Lake, N.J., August 4, 2010 – Par Pharmaceutical Companies, Inc. (NYSE:PRX) today reported results for the second quarter ended June 30, 2010.


For the second quarter ended June 30, 2010, the Company reported total revenues of $255.5 million and income from continuing operations of $18.0 million, or $0.51 per diluted share.  These results included payments to new development partners of $17 million, income from a litigation settlement of $4.1 million, the resolution of tax contingencies of $3.7 million, and non-cash interest expense of $0.5 million.  After these items, adjusted income from continuing operations (non-GAAP measure) was $22.7 million.  On an adjusted cash basis (non-GAAP measure), which excludes amortization expenses, income from continuing operations was $25.1 million, or $0.71 per diluted share for the second quarter 2010.  This is compared to reported revenues of $404.0 million and income from continuing operations of $24.0 million, or $0.71 per diluted share, for the same period in 2009, which included a one-time item.  On an adjusted cash basis, income from continuing operations for the second quarter 2009 was $27.2 million, or $0.80 per diluted share.


For the six months ended June 30, 2010, the Company reported total revenues of $547.4 million and income from continuing operations of $44.5 million, or $1.26 per diluted share. On an adjusted cash basis (non-GAAP measure), which excludes amortization expenses and certain items as detailed in the attached reconciliation, income from continuing operations was $51.4 million, or $1.46 per diluted share.  This compares to reported revenues of $608.0 million and income from continuing operations of $40.2 million, or $1.19 per diluted share, for the same period in 2009.  On an adjusted cash basis, income from continuing operations for the first six months of 2009 was $47.0 million, or $1.39 per diluted share.



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Second Quarter Highlights

Key Product Sales

Metoprolol:  For the second quarter 2010, net sales of metoprolol succinate were $119.6 million, a decrease of 35% from the first quarter 2010.  The decrease was driven by a decline in volume and price due to competition on the 100mg and 200mg strengths.  Par Pharmaceutical, the Companys generic drug division, is the authorized generic for all strengths of AstraZenecas Toprol® XL.


Clonidine:  Net sales for the second quarter 2010 were $26.3 million, compared to $18.5 million for the first quarter.  The increase was due to the availability of additional supply.  


Sumatriptan: Net sales of sumatriptan succinate were $17.5 million for the second quarter 2010, compared to $17.3 million for the first quarter 2010.  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 2010.


Meclizine: Net sales for the second quarter 2010 were $9.4 million, compared to $10.2 million for the first quarter 2010.  The decrease was driven by a decline in volume and price due to competition in the second quarter.  


Tramadol ER:  Net sales for the second quarter 2010 were $5.7 million, compared to $5.3 million for the first quarter.  Par Pharmaceutical launched tramadol ER in November 2009.


Other generic products:  For the second quarter 2010, net sales from all other generic products were $53.5 million, compared to $37.6 million for the first quarter. The increase was due primarily to the impact of quarter over quarter in-transit revenue recognition, as well as the release of backlogs on certain products. (The first quarter other generic products revenue was negatively impacted due primarily to the deferral of revenue related to shipments at quarter-end without the recognition of revenues related to shipments from the fourth quarter due to the Company’s annual year-end shut down.)


Megace® ES:  Net sales were $15.5 million for the second quarter 2010, compared to $13.8 million for the first quarter.  The increase was due to the return to normal buying patterns of the wholesalers.


Nascobal® B12 Nasal Spray:  Net sales were $4.4 million for the second quarter 2010, compared to $3.6 million for the first quarter.  The increase was due primarily to an increase in prescription volume.


Total net revenues for the second quarter 2010 were $255.5 million, down $148.5 million, or 37%, from the second quarter 2009.  The decline was principally driven by additional competition in metoprolol, which was partially offset by 2009 product launches such as clonidine, tramadol ER, and Nascobal.



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Gross margin for the second quarter 2010 increased due primarily to the launches of clonidine, tramadol ER, and nateglinide in second half of 2009, and increases in other generic products.  These gains were partially offset by lower metroprolol sales and the impact on price resulting from the recently enacted U.S. healthcare reform.


 

 

 

2Q 2010

 

2Q 2009

 

 

 

 

 

$

%

 

$

%

 

 

 

Key Par (Generic) Products (1)

 

 $   46.7

26.2%

 

 $   50.7

15.0%

 

 

 

 

 

 

 

 

 

 

 

 

 

All other Par (Generic)

 

      27.0

50.4%

 

20.0    

44.4%

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Par (Generic)

 

 $   73.7

31.7%

 

 $   70.7

18.5%

 

 

 

 

 

 

 

 

 

 

 

 

 

Strativa (Branded) Products

 

 $   17.8

75.8%

 

 $   15.7

71.9%

 

 

 

 

 

 

 

 

 

 

 

 

 

Total (All Products)

 

 $   91.5

35.8%

 

 $   86.4

21.4%

 

 

 

 

 

 

 

 

 

 

 

 

(1) 2010 is comprised of metoprolol, clonidine, sumatriptan, meclizine and tramadol ER.  2009 does not include clonidine or tramadol ER as these products were launched subsequent to 2Q 2009.


Research and development (R&D) expenses in the second quarter 2010 were $22.7 million, compared to $5.9 million in the second quarter 2009.  The increase was due to two third-party generic product agreements entered into during the second quarter 2010, totaling $17 million.


Selling, general and administrative (SG&A) expenses for the second quarter 2010 increased to $48.9 million, compared to $44.1 million in the second quarter 2009.  This increase reflects expenses associated with pre-commercialization marketing activities related to the anticipated third quarter 2010 launches of Oravig and Zuplenz®, as well as one-time severance charges.


Cash and cash equivalents and marketable securities aggregate balance as of June 30, 2010, was $226 million.


Product and Pipeline Update

In April 2010, Par Pharmaceutical and its development partner MN Pharmaceuticals of Turkey announced that they had entered into a settlement agreement with sanofi-aventis that resolves patent litigation related to their generic version Eloxatin® (oxaliplatin injection) product. Under the terms of the settlement, Par would begin selling the generic version of Eloxatin in August 2012, or earlier under certain circumstances.  Eloxatin had combined U.S. sales of approximately $636 million for the twelve months ended March 31, 2010, according to IMS Health.


In April 2010, Strativa Pharmaceuticals, the Companys branded drugs division, announced that it received FDA approval for Oravig (miconazole) buccal tablets for the treatment of oropharyngeal candidiasis (OPC).  Strativa intends to launch Oravig in the third quarter of 2010.



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In May 2010, Par Pharmaceutical announced that its partner Glenmark Generics entered into a settlement agreement with an affiliate of Merck & Co. that resolves patent litigation related to Glenmark’s submission of an abbreviated new drug application for a generic version of Zetia®.  Under the terms of the settlement agreement, Par will be able to launch the product on December 12, 2016, or earlier under certain circumstances, ahead of the April 25, 2017 expiration of Merck’s patent exclusivity for Zetia.


In July 2010, Par Pharmaceutical successfully launched omeprazole and sodium bicarbonate capsules, which are a generic form of Santarus’ Zegerid®.  Annual U.S. sales of Zegerid capsules are approximately $195 million, according to IMS Health.


In July 2010, Strativa Pharmaceuticals received FDA approval for Zuplenz® (ondansetron) oral soluble film.  Strativa intends to launch Zuplenz in the fourth quarter of 2010.


Par Pharmaceutical currently has approximately 28 ANDAs pending with the FDA, 12 of which Par believes to be first-to-file opportunities with a brand value of approximately $7.6 billion.


Conference Call

The Company has scheduled a conference call for Wednesday, August 4th at 9:00am EDT to discuss results for the second quarter 2010.  The Company invites investors and the general public to listen to a webcast of the conference call.  Access to the live webcast can be made via the Company’s website at http://www.parpharm.com and will be available for two weeks.


Dial-in Information

Domestic:

800-659-2056

International:

617-614-2714

Passcode:

71836499


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:

84280770


Non-GAAP Measures

The Company believes it prepared its condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (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 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 measure “Adjusted Income from Continuing Operations” 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



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facilitating comparison across reporting periods. In addition, the accompanying press release presents “Adjusted Cash EPS”, which is a non-GAAP financial measure.  Adjusted Cash EPS represents net income adjusted for amortization expense related to intangible assets, in addition to the item adjusted for in Adjusted Income from Continuing Operations.  The Company believes that this measure is utilized by industry analysts in comparing the Company’s results to that of similar companies within our industry.  Importantly, the Company believes non-GAAP financial measures should be considered in addition to, and not in lieu of, 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 U.S.-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.


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)


 

 

June 30,

 

December 31,

 

 

2010

 

2009

      ASSETS

 

 

 

 

Current assets:

 

 

 

 

    Cash and cash equivalents

 

$

175,249 

 

$

121,668 

    Available for sale marketable debt securities

 

50,793 

 

39,525 

    Accounts receivable, net  

 

132,177 

 

154,837 

    Inventories

 

68,822 

 

80,729 

    Prepaid expenses and other current assets

 

17,992 

 

14,051 

    Deferred income tax assets

 

26,356 

 

26,356 

    Income taxes receivable

 

3,820 

 

9,005 

    Total current assets

 

475,209 

 

446,171 

 

 

 

 

 

Property, plant and equipment, net

 

73,675 

 

74,696 

Available for sale marketable debt and equity securities

 

425 

 

475 

Intangible assets, net

 

96,618 

 

69,272 

Goodwill

 

63,729 

 

63,729 

Other assets

 

1,465 

 

989 

Non-current deferred income tax assets, net

 

72,512 

 

68,495 

Total assets

 

$

783,633 

 

$

723,827 

 

 

 

 

 

      LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

Current liabilities:

 

 

 

 

    Current portion of long-term debt

 

$

47,213 

 

$

46,175 

    Accounts payable

 

32,554 

 

22,662 

    Payables due to distribution agreement partners

 

44,444 

 

58,552 

    Accrued salaries and employee benefits

 

11,936 

 

16,072 

    Accrued government pricing liabilities

 

36,664 

 

24,713 

    Accrued expenses and other current liabilities

 

17,015 

 

14,903 

    Total current liabilities

 

189,826 

 

183,077 

 

 

 

 

 

Long-term debt, less current portion

 

 

Other long-term liabilities

 

40,166 

 

42,097 

Commitments and contingencies

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

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

 

 

 

 

         37,944,451 and 37,662,231 shares

 

379 

 

377 

    Additional paid-in capital

 

344,010 

 

331,667 

    Retained earnings

 

281,091 

 

236,398 

    Accumulated other comprehensive gain

 

119 

 

357 

    Treasury stock, at cost 2,886,503 and 2,815,879 shares

 

(71,958)

 

(70,146)

    Total stockholders' equity

 

553,641 

 

498,653 

Total liabilities and stockholders’ equity

 

$

783,633 

 

$

723,827 






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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 27,

 

June 30,

 

June 27,

 

2010

 

2009

 

2010

 

2009

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

    Net product sales

$

248,739 

 

$

400,149 

 

$

537,017 

 

$

600,372 

    Other product related revenues

6,735 

 

3,852 

 

10,389 

 

7,664 

Total revenues

255,474 

 

404,001 

 

547,406 

 

608,036 

Cost of goods sold

164,015 

 

317,593 

 

372,437 

 

457,559 

    Gross margin

91,459 

 

86,408 

 

174,969 

 

150,477 

Operating expenses:

 

 

 

 

 

 

 

    Research and development

22,660 

 

5,937 

 

27,312 

 

13,109 

    Selling, general and administrative

48,865 

 

44,117 

 

90,100 

 

77,077 

    Settlements and loss contingencies, net

(4,068)

 

61 

 

(4,006)

 

(3,315)

    Restructuring costs

 

81 

 

 

1,482 

Total operating expenses

67,457 

 

50,196 

 

113,406 

 

88,353 

Gain on sale of product rights and other

146 

 

265 

 

5,921 

 

1,365 

Operating income

24,148 

 

36,477 

 

67,484 

 

63,489 

Gain on bargain purchase

 

3,021 

 

 

3,021 

Gain on extinguishment of senior subordinated convertible notes

 

504 

 

 

749 

Loss on marketable securities and other investments, net

 

 

 

(55)

Interest income

273 

 

667 

 

601 

 

1,824 

Interest expense

(918)

 

(2,595)

 

(1,826)

 

(5,162)

Income from continuing operations before provision
    for income taxes

23,503 

 

38,074 

 

66,259 

 

63,866 

Provision for income taxes

5,468 

 

14,087 

 

21,798 

 

23,624 

Income from continuing operations

18,035 

 

23,987 

 

44,461 

 

40,242 

Discontinued operations:

 

 

 

 

 

 

 

(Benefit) provision for income taxes

(360)

 

176 

 

(232)

 

352 

Gain (loss) from discontinued operations

360 

 

(176)

 

232 

 

(352)

Net income

$

18,395 

 

$

23,811 

 

$

44,693 

 

$

39,890 

 

 

 

 

 

 

 

 

Basic earnings (loss) per share of common stock:

 

 

 

 

 

 

 

Income from continuing operations

$

0.53 

 

$

0.71 

 

$

1.31 

 

$

1.20 

Gain (loss) from discontinued operations

0.01 

 

0.00 

 

0.01 

 

(0.01)

Net income

$

0.54 

 

$

0.71 

 

$

1.32 

 

$

1.19 

 

 

 

 

 

 

 

 

Diluted earnings (loss) per share of common stock:

 

 

 

 

 

 

 

Income from continuing operations

$

0.51 

 

$

0.71 

 

$

1.26 

 

$

1.19 

Gain (loss) from discontinued operations

0.01 

 

0.00 

 

0.01 

 

(0.01)

Net income

$

0.52 

 

$

0.71 

 

$

1.27 

 

$

1.18 

 

 

 

 

 

 

 

 

Weighted average number of common shares outstanding:

 

 

 

 

 

 

 

  Basic

34,112 

 

33,630 

 

34,021 

 

33,616 

  Diluted

35,475 

 

33,771 

 

35,273 

 

33,772 







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

(In Thousands, Except Per Share Data)

(Unaudited)

 

Three Months Ended

 

June 30,

 

June 27,

 

2010

 

2009

Income from Continuing Operations

$

18,035 

 

$

23,987 

 

 

 

 

Upfront and development milestone payments

17,000 

 

Litigation settlement

(4,130)

 

Non-cash interest expense

524 

 

1,249 

Gain on bargain purchase

 

(3,021)

Restructuring costs

 

81 

Sum of adjustments, pre-tax

$

13,394 

 

($1,691)

Estimated tax on adjustments

(5,090)

 

643 

Resolution of tax contingencies

(3,657)

 

Adjusted Income from Continuing Operations (non-GAAP measure)

$

22,682 

 

$

22,939 

 

 

 

 

Amortization Expense

3,904 

 

6,825 

    Estimated tax impact

(1,484)

 

(2,594)

Amortization Expense, net of tax

2,420 

 

4,232 

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

25,103 

 

27,170 

    “Adjusted Cash EPS” from Continuing Operations (non-GAAP

      measure)

$

0.71 

 

$

0.80 

 

 

 

 

Diluted weighted average shares outstanding

35,475 

 

33,771 


 

 

 

 

 

Six Months Ended

 

June 30,

 

June 27,

 

2010

 

2009

Income from Continuing Operations

$

44,461 

 

$

40,242 

 

 

 

 

Upfront and development milestone payments

17,000 

 

1,000 

Sale of product rights

(5,000)

 

(1,100)

Litigation settlement

(4,130)

 

Non-cash interest expense

1,038 

 

2,842 

Change in estimate related to final Pentech settlement

 

(3,412)

Gain on bargain purchase

 

(3,021)

Restructuring costs

 

1,482 

Sum of adjustments, pre-tax

$

8,908 

 

($2,209)

Estimated tax on adjustments

(3,385)

 

839 

Resolution of tax contingencies

(3,657)

 

Adjusted Income from Continuing Operations (non-GAAP measure)

$

46,327 

 

$

38,872 

 

 

 

 

Amortization Expense

8,154 

 

13,077 

    Estimated tax impact

(3,099)

 

(4,969)

Amortization Expense, net of tax

5,055 

 

8,108 

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

51,382 

 

46,980 

    “Adjusted Cash EPS” from Continuing Operations (non-GAAP

      measure)

$

1.46 

 

$

1.39 

 

 

 

 

Diluted weighted average shares outstanding

35,273 

 

33,772