EX-99.1 2 q32010earningsfinal.htm EARNINGS PRESS RELEASE _



[q32010earningsfinal002.gif]


Contact:

Allison Wey

Investor Relations and Corporate Affairs

Par Pharmaceutical Companies, Inc.

(201) 802-4000



PAR PHARMACEUTICAL COMPANIES REPORTS THIRD QUARTER 2010 RESULTS


- Reports GAAP EPS of $0.86; Adjusted Cash EPS of $0.88 -

 - Achieves Record Quarterly Gross Margin of $103 Million –

-  Convertible Debentures Mature, Company Now Debt-free -

- Oravig Launches -



Woodcliff Lake, N.J., November 3, 2010 Par Pharmaceutical Companies, Inc. (NYSE:PRX) today reported results for the third quarter ended September 30, 2010.


For the third quarter ended September 30, 2010, the Company reported total revenues of $234.4 million and income from continuing operations of $30.7 million, or $0.86 per diluted share.  These results included a $2.0 milestone payment to Tris Pharma, Inc., a $2.3 million payment for litigation settlement, a $3.6 million gain on marketable securities, and a $2.0 million manufacturing tax benefit.  After these items, adjusted income from continuing operations (non-GAAP measure) was $29.4 million.  On an adjusted cash basis (non-GAAP measure), which excludes amortization expenses, income from continuing operations was $31.3 million, or $0.88 per diluted share for the third quarter 2010.  This is compared to reported revenues of $294.8 million and income from continuing operations of $26.5 million, or $0.76 per diluted share, for the same period in 2009.  On an adjusted cash basis, income from continuing operations for the third quarter 2009 was $30.2 million, or $0.88 per diluted share.


For the nine months ended September 30, 2010, the Company reported total revenues of $781.8 million and income from continuing operations of $75.1 million, or $2.12 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 $82.7 million, or $2.34 per diluted share.  This compares to reported revenues of $902.8 million and income from continuing operations of $66.8 million, or $1.97 per diluted share, for the same period in 2009.  On an adjusted cash basis, income from continuing operations for the first nine months of 2009 was $77.8 million, or $2.29 per diluted share.





2



Third Quarter Highlights

Key Product Sales

Metoprolol:  For the third quarter 2010, net sales of metoprolol succinate were $97.4 million, compared to $119.6 in the second quarter 2010.  The decrease was driven by a decline in volume and price due to competition on all strengths.  Par Pharmaceutical, the Company’s generic drug division, is the authorized generic for all strengths of AstraZeneca’s Toprol® XL.

Sumatriptan: Net sales of sumatriptan succinate were $18.3 million for the third quarter 2010, compared to $17.5 million for the second 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 third quarter 2010.

Omeprazole sodium bicarbonate capsules: Net sales were $13.5 million for the third quarter 2010.  Par launched omeprazole sodium bicarbonate capsules on June 27, 2010.   Net sales of $0.6 million were recognized in the second quarter.

Clonidine:  Net sales for the third quarter 2010 were $7.8 million, compared to $26.3 million for the second quarter.  The decrease was due to a decline in volume and price due to competition and the release of backorders in the second quarter.  

Meclizine: Net sales for the third quarter 2010 were $6.2 million, compared to $9.4 million for the second quarter 2010.  The decrease was driven by a decline in volume and price due to competition that began in the second quarter.  

Tramadol ER:  Net sales for the third quarter 2010 were $5.5 million, compared to $5.7 million for the second quarter.  Par Pharmaceutical remains one of only two suppliers of tramadol ER since its launch in November 2009.

Other generic products:  For the third quarter 2010, net sales from all other generic products were $61.0 million, compared to $52.9 million for the second quarter.  The increase was driven by additional volume in certain products and increased royalties, principally related to the September launch of diazepam.

Megace® ES:  Net sales were $16.8 million for the third quarter 2010, compared to $15.5 million for the second quarter.  The increase was primarily driven by wholesaler buying patterns.

Nascobal®:  Net sales were $4.9 million for the third quarter 2010, compared to $4.4 million for the second quarter.  The increase was due primarily to an increase in prescription volume.

Total net revenues for the third quarter 2010 were $234.4 million compared to $294.8 million for the third quarter 2009.  The decline was principally driven by additional competition in metoprolol, clonidine, and meclizine, which was partially offset by the 2009 product launches of tramadol ER and Nascobal and the 2010 launch of omeprazole sodium bicarbonate capsules.



.



3



Gross margin for the third quarter 2010 increased due primarily to the launch of omeprazole, as well as increases in other generic products.  These gains were partially offset by lower metroprolol, clonidine and meclizine sales and the impact on price resulting from the recently enacted U.S. healthcare reform.


 

 

 

3Q 2010

 

3Q 2009

 

 

 

 

 

$

%

 

$

%

 

 

 

Key Par (Generic) Products (1)

 

 $   50.0

33.6%

 

 $   45.4

21.7%

 

 

 

 

 

 

 

 

 

 

 

 

 

All other Par (Generic)

 

      34.7

56.9%

 

27.5    

45.4%

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Par (Generic)

 

 $   84.7

40.4%

 

 $   72.9

27.1%

 

 

 

 

 

 

 

 

 

 

 

 

 

Strativa (Branded) Products

 

 $   18.6

75.2%

 

 $   19.2

75.7%

 

 

 

 

 

 

 

 

 

 

 

 

 

Total (All Products)

 

 $ 103.3

44.1%

 

 $   92.1

31.3%

 

 

 

 

 

 

 

 

 

 

 

 

(1) 2010 is comprised of metoprolol, clonidine, sumatriptan, omeprazole, meclizine and tramadol ER.  2009 does not include tramadol ER or omeprazole as these products were launched subsequent to 3Q 2009.


Research and development (R&D) expenses in the third quarter 2010 were $10.1 million, compared to $6.5 million in the third quarter 2009.  The increase was driven by a $2 million milestone payment, and higher biostudy and material costs.


Selling, general and administrative (SG&A) expenses for the third quarter 2010 increased to $50.3 million, compared to $45.3 million in the third quarter 2009.  This increase reflects expenses associated with pre-commercialization marketing activities related to the third quarter launch of Oravig and fourth quarter launch of Zuplenz, and increased legal costs.


Provision for income taxes for the third quarter 2010 reflected the benefit from higher than previously estimated tax deductions specific to U.S. domestic manufacturing companies.


Cash and cash equivalents and marketable securities aggregate balance as of September 30, 2010, was $219.8 million, which included the repayment of the outstanding balance of the Company’s Senior Subordinated Convertible Notes in the amount of $47.7 million.     


In October 2010, the Company secured a revolving credit facility in an aggregate principal amount of up to $75 million with an expansion option of up to an additional $25 million.  


Product and Pipeline Update

In August 2010, Strativa Pharmaceuticals launched Oravig, an anti-fungal therapy to be used for the treatment of oropharyngeal candidiasis. During the initial launch phase of the product, Strativa will recognize revenue and all associated costs of sales as it is prescribed to patients based upon an assessment of multiple inputs, including third party prescription data.  Due to the timing of the launch, net sales recognized in the third quarter of 2010 were negligible.         


In October 2010, Strativa Pharmaceuticals launched Zuplenz (ondansetron) oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced nausea and vomiting.  Strativa received FDA approval for Zuplenz in the third quarter of 2010.  Similar to our recognition of Oravig revenues, initial Zuplenz revenues will be recorded on an as-prescribed basis beginning in the fourth quarter of 2010.



.



4




In October 2010, Par Pharmaceutical successfully launched a limited supply of hydrocodone polistirex and chlorpheniramine polistirex (CIII) extended-release (ER) oral suspension, a generic version of UCB’s Tussionex®.  Annual U.S. sales of Tussionex® are approximately $226 million, according to IMS Health data.  


In October 2010, Strativa Pharmaceuticals signed an amended and restated license and supply agreement with Swedish Orphan Biovitrum (Sobi) covering the European development and commercialization rights of Nascobal®.  Under the terms of the amended agreement, Sobi will conduct and pay for all development activities to obtain European regulatory approval of Nascobal.  Strativa and Sobi will share in the expense of upgrading Strativa’s manufacturing facility to comply with European regulations.  Subject to regulatory approval, Strativa will supply European-ready product to Sobi, and Sobi will be responsible for commercializing the product in Europe, including all sales and marketing activities.  Strativa will receive double-digit royalty payments based on Sobi’s net sales of Nascobal in Europe.  


Par Pharmaceutical currently has approximately 27 ANDAs pending with the FDA, 11 of which Par believes to be first-to-file opportunities with a brand value of approximately $7.3 billion.


Conference Call

The Company has scheduled a conference call for Wednesday, November 3rd at 8:30am EDT to discuss results for the third 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:

866-804-6920

International:

857-350-1666

Passcode:

21985525


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

Replay Information

Domestic:

888-286-8010

International:

617-801-6888

Passcode:

94668458


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 performances.  Management uses



.



5



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 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.





.



6




PAR PHARMACEUTICAL COMPANIES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In Thousands, Except Share Data)

(Unaudited)


 

 

September 30,

 

December 31,

 

 

2010

 

2009

      ASSETS

 

 

 

 

Current assets:

 

 

 

 

    Cash and cash equivalents

 

$

177,080 

 

$

121,668 

    Available for sale marketable debt securities

 

42,717 

 

39,525 

    Accounts receivable, net  

 

99,991 

 

154,837 

    Inventories

 

76,663 

 

80,729 

    Prepaid expenses and other current assets

 

17,397 

 

14,051 

    Deferred income tax assets

 

26,356 

 

26,356 

    Income taxes receivable

 

9,636 

 

9,005 

    Total current assets

 

449,840 

 

446,171 

 

 

 

 

 

Property, plant and equipment, net

 

73,497 

 

74,696 

Available for sale marketable debt and equity securities

 

300 

 

475 

Intangible assets, net

 

99,540 

 

69,272 

Goodwill

 

63,729 

 

63,729 

Other assets

 

3,187 

 

989 

Non-current deferred income tax assets, net

 

71,711 

 

68,495 

Total assets

 

$

761,804 

 

$

723,827 

 

 

 

 

 

      LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

Current liabilities:

 

 

 

 

    Current portion of long-term debt

 

$

 

$

46,175 

    Accounts payable

 

32,909 

 

22,662 

    Payables due to distribution agreement partners

 

25,371 

 

58,552 

    Accrued salaries and employee benefits

 

13,612 

 

16,072 

    Accrued government pricing liabilities

 

35,126 

 

24,713 

    Accrued expenses and other current liabilities

 

18,196 

 

14,903 

    Total current liabilities

 

125,214 

 

183,077 

 

 

 

 

 

Long-term debt, less current portion

 

 

Other long-term liabilities

 

41,065 

 

42,097 

Commitments and contingencies

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

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

 

 

 

 

         38,302,445 and 37,662,231 shares

 

383 

 

377 

    Additional paid-in capital

 

355,707 

 

331,667 

    Retained earnings

 

311,625 

 

236,398 

    Accumulated other comprehensive gain

 

158 

 

357 

    Treasury stock, at cost 2,901,267 and 2,815,879 shares

 

(72,348)

 

(70,146)

    Total stockholders' equity

 

595,525 

 

498,653 

Total liabilities and stockholders’ equity

 

$

761,804 

 

$

723,827 

 

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



.



7




PAR PHARMACEUTICAL COMPANIES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In Thousands, Except Per Share Data)

(Unaudited)


 

Three Months Ended

 

Nine Months Ended

 

September 30,

 

October 3,

 

September 30,

 

October 3,

 

2010

 

2009

 

2010

 

2009

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

    Net product sales

$

226,131 

 

$

290,961 

 

$

763,148 

 

$

891,333 

    Other product related revenues

8,309 

 

3,841 

 

18,698 

 

11,505 

Total revenues

234,440 

 

294,802 

 

781,846 

 

902,838 

Cost of goods sold

131,146 

 

202,664 

 

503,583 

 

660,223 

    Gross margin

103,294 

 

92,138 

 

278,263 

 

242,615 

Operating expenses:

 

 

 

 

 

 

 

    Research and development

10,145 

 

6,458 

 

37,457 

 

19,567 

    Selling, general and administrative

50,302 

 

45,306 

 

140,402 

 

122,383 

    Settlements and loss contingencies, net

2,312 

 

62 

 

(1,694)

 

(3,253)

    Restructuring costs

 

(230)

 

 

1,252 

Total operating expenses

62,759 

 

51,596 

 

176,165 

 

139,949 

Gain on sale of product rights and other

79 

 

1,835 

 

6,000 

 

3,200 

Operating income

40,614 

 

42,377 

 

108,098 

 

105,866 

Gain on bargain purchase

 

 

 

3,021 

Gain on extinguishment of senior subordinated convertible notes

 

1,615 

 

 

2,364 

Gain (loss) on marketable securities and other investments, net

3,567 

 

 

3,567 

 

(55)

Interest income

341 

 

504 

 

942 

 

2,328 

Interest expense

(928)

 

(1,773)

 

(2,754)

 

(6,935)

Income from continuing operations before provision
    for income taxes

43,594 

 

42,723 

 

109,853 

 

106,589 

Provision for income taxes

12,933 

 

16,209 

 

34,731 

 

39,833 

Income from continuing operations

30,661 

 

26,514 

 

75,122 

 

66,756 

Discontinued operations:

 

 

 

 

 

 

 

Provision (benefit) for income taxes

127 

 

176 

 

(105)

 

528 

(Loss) gain from discontinued operations

(127)

 

(176)

 

105 

 

(528)

Net income

$

30,534 

 

$

26,338 

 

$

75,227 

 

$

66,228 

 

 

 

 

 

 

 

 

Basic earnings (loss) per share of common stock:

 

 

 

 

 

 

 

Income from continuing operations

$

0.89 

 

$

0.79 

 

$

2.20 

 

$

1.98 

(Loss) gain from discontinued operations

(0.00)

 

(0.01)

 

0.00 

 

(0.02)

Net income

$

0.89 

 

$

0.78 

 

$

2.20 

 

$

1.96 

 

 

 

 

 

 

 

 

Diluted earnings (loss) per share of common stock:

 

 

 

 

 

 

 

Income from continuing operations

$

0.86 

 

$

0.77 

 

$

2.12 

 

$

1.97 

(Loss) gain from discontinued operations

(0.00)

 

(0.01)

 

0.00 

 

(0.02)

Net income

$

0.86 

 

$

0.76 

 

$

2.12 

 

$

1.95 

 

 

 

 

 

 

 

 

Weighted average number of common shares outstanding:

 

 

 

 

 

 

 

  Basic

34,310 

 

33,710 

 

34,117 

 

33,647 

  Diluted

35,684 

 

34,245 

 

35,410 

 

33,930 

 

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



.



8




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

(In Thousands, Except Per Share Data)

(Unaudited)

 

Three Months Ended

 

September 30,

 

October 3,

 

2010

 

2009

Income from Continuing Operations

$

30,661 

 

$

26,514 

 

 

 

 

Upfront and development milestone payments

2,000 

 

Litigation settlement

2,250 

 

Non-cash interest expense

533 

 

982 

Abrika earn-out payment

(3,567)

 

Restructuring costs

 

(230)

Sum of adjustments, pre-tax

$

1,216 

 

$

752 

Estimated tax on adjustments

(462)

 

(286)

Domestic manufacturing tax benefit

(2,009)

 

Adjusted Income from Continuing Operations (non-GAAP measure)

$

29,406 

 

$

26,980 

 

 

 

 

Amortization Expense

3,079 

 

5,144 

    Estimated tax impact

(1,170)

 

(1,955)

Amortization Expense, net of tax

1,909 

 

3,189 

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

31,315 

 

30,169 

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

$

0.88 

 

$

0.88 

 

 

 

 

Diluted weighted average shares outstanding

35,684 

 

34,245 


 

Nine Months Ended

 

September 30,

 

October 3,

 

2010

 

2009

Income from Continuing Operations

$

75,122 

 

$

66,756 

 

 

 

 

Upfront and development milestone payments

19,000 

 

1,000 

Non-cash interest expense

1,571 

 

3,824 

Litigation settlement

(1,880)

 

Abrika earn-out payment

(3,567)

 

Sale of product rights

(5,000)

 

Change in estimate related to final Pentech settlement

 

(3,412)

Gain on bargain purchase

 

(3,021)

Restructuring costs

 

1,252 

Sum of adjustments, pre-tax

$

10,124 

 

($357)

Estimated tax on adjustments

(3,847)

 

136 

Resolution of tax contingencies

(3,657)

 

Domestic manufacturing tax benefit

(2,009)

 

Adjusted Income from Continuing Operations (non-GAAP measure)

$

75,733 

 

$

66,535 

 

 

 

 

Amortization Expense

11,233 

 

18,221 

    Estimated tax impact

(4,269)

 

(6,924)

Amortization Expense, net of tax

6,964 

 

11,297 

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

82,697 

 

77,832 

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

$

2.34 

 

$

2.29 

 

 

 

 

Diluted weighted average shares outstanding

35,410 

 

33,930 


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



.