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Jazz Pharmaceuticals Announces Third Quarter 2012 Results

-- Company Reports Revenues of $176 Million, Excluding $8 Million from the Women's Health Discontinued Operations --

DUBLIN, Nov. 8, 2012 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the third quarter ended September 30, 2012.  These results reflect the first full quarter of operations following completion of the EUSA Pharma acquisition in June.  The company also reported the results of its women's health business, which was sold in October, as discontinued operations.

"During the third quarter, we completed the integration of EUSA Pharma's U.S. commercial business, and our R&D group is working to coordinate worldwide Erwinaze® and Asparec® development activities," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals.  "I am very pleased that we have been able to complete two important acquisitions and a divestiture of our non-core women's health business this year, while continuing to deliver solid results fueled by growing sales of key products."

Third quarter 2012 adjusted income from continuing operations, which excluded contributions from the discontinued women's health business, was $78.6 million, or $1.29 per diluted share.  Adjusted income for the discontinued women's health business was $3.0 million, or $0.05 per diluted share, for a total of $1.34 per share on a combined basis. 

GAAP income from continuing operations for the third quarter of 2012 was $33.6 million, or $0.56 per diluted share, and GAAP loss from the discontinued women's health business was $0.4 million, or $0.01 per diluted share.  GAAP net income for the third quarter of 2012 was $33.2 million, or $0.55 per diluted share.

GAAP net income was impacted by various acquisition-related expenses, which included transaction, integration and restructuring expenses, as well as certain non-cash expenses.  A reconciliation of certain GAAP to non-GAAP adjusted information is included with this press release.

Revenues and Product Sales

Total revenues for the quarter ended September 30, 2012 were $175.5 million, including net sales, royalties and contract revenues, but excluding the $8.1 million of net sales attributable to the divested women's health business that were reported separately as discontinued operations.  

A significant increase in total net sales for the third quarter of 2012 over the prior year third quarter resulted from the addition of net sales from the expanded product portfolio acquired in the Azur Pharma and EUSA Pharma transactions, as well as continued growth in net sales of Xyrem® (sodium oxybate) oral solution.    

Net sales from continuing operations for the third quarter of 2012 included:

  • Xyrem:  Net sales of Xyrem increased by 64% to $102.6 million for the third quarter of 2012, compared to net sales of $62.5 million in the third quarter of 2011. During the third quarter of 2012, the average number of active Xyrem patients was approximately 10,200.
  • Erwinaze/Erwinase: Worldwide net sales of Erwinaze®/Erwinase® (asparaginase Erwinia chrysanthemi) were $31.7 million.  Erwinaze was approved by the U.S. FDA in November 2011.
  • Prialt:  Third quarter 2012 net sales of Prialt® (ziconotide) intrathecal infusion were $5.4 million, compared to $5.0 million in the prior year quarter on a pro forma basis.
  • Psychiatry Products:  Net sales of the company's psychiatry products, including once-daily Luvox CR® (fluvoxamine maleate), FazaClo® (clozapine, USP) HD and FazaClo LD, were $21.0 million for the third quarter of 2012.  Net sales of these products in the prior year quarter were $19.7 million on a pro forma basis.
  • Other:  Net sales of other products for the third quarter of 2012 were $13.4 million. These products include other non-promoted products acquired in the EUSA Pharma and Azur Pharma transactions. 

Other Financial Highlights

  • Cost of product sales increased by $28.7 million compared to the third quarter of 2011 due to higher net sales and $10.3 million of purchase accounting inventory fair value step-up.
  • Selling, general and administrative expenses increased by $30.4 million compared to the prior year quarter, primarily due to increased headcount and related expenses from the addition of the Azur Pharma and EUSA Pharma businesses.
  • Intangible asset amortization for the third quarter of 2012 was $19.7 million, related primarily to the company's expanded product portfolio.
  • Interest expense increased by $7.6 million compared to the third quarter of 2011 due to inclusion of a full quarter's interest under the company's term loan which had a balance of $462.3 million as of September 30, 2012.

Recent Transaction and Balance Sheet Update

On October 15, 2012, Jazz Pharmaceuticals completed the sale of its women's health business to Meda for $97.6 million in cash, including $2.6 million for certain purchased inventory.  Following this transaction, Jazz Pharmaceuticals has approximately $300 million in cash and cash equivalents.

2012 Financial Guidance

Jazz Pharmaceuticals is providing 2012 guidance for continuing operations which reflects the sale of its women's health business and the treatment of that business as a discontinued operation. 


2012 Guidance for
Continuing Operations



Revenues

$575-585 million



Total Net Product Sales                                                           

$570-580 million

     -Xyrem Net Sales

$375-380 million

     -Erwinaze/Erwinase Net Sales (partial year)1

$65-69 million



Adjusted Gross Margin %2

88-91%



Adjusted Combined SG&A and R&D Expenses3

$200-205 million



GAAP Income from Continuing Operations                                                         

$140-151 million

Adjusted Net Income4

$280-286 million



GAAP Income from Continuing Operations Per Diluted Share

$2.34-$2.49

Adjusted Net Income Per Diluted Share4

$4.65-$4.75

 

1.

Expected sales from and after the completion of the EUSA acquisition on June 12, 2012.

2.

Excludes $17‑18 million of purchase accounting inventory fair value step-up and $1 million of share‑based compensation expense from estimated GAAP Gross Margin of 85-88%.

3.

Excludes $22‑24 million of transaction, integration and restructuring costs, $22‑23 million of share‑based compensation expense, and $2 million related to a change in the fair value of contingent consideration from estimated GAAP Combined SG&A and R&D Expenses of $245-250 million.

4.

See "Non‑GAAP Financial Measures" below. A reconciliation of GAAP to non‑GAAP adjusted 2012 financial guidance is included with this press release.

Conference Call Details

Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. EST (9:30 p.m. GMT) to provide a business and financial update and discuss 2012 third quarter results and 2012 guidance.  The live webcast may be accessed from the Investors & Media section of the company's website at www.jazzpharmaceuticals.com.  Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary.  Investors may participate in the conference call by dialing +1 866-783-2137 in the U.S., or +1 857-350-1596 outside the U.S., and entering passcode 22418849.

An archived version of the webcast will be available for at least one week in the Investors & Media section of the Jazz Pharmaceuticals website a www.jazzpharmaceuticals.com.

About Jazz Pharmaceuticals

Jazz Pharmaceuticals plc is a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing innovative products that address unmet medical needs. The company has a diverse portfolio of products in the areas of narcolepsy, oncology, pain and psychiatry. The company's U.S. marketed products in these areas include: Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi), Prialt® (ziconotide) intrathecal infusion, Luvox CR® (fluvoxamine maleate), FazaClo® (clozapine, USP) HD and FazaClo LD. Outside of the U.S., Jazz Pharmaceuticals also has a number of products marketed by its international division, EUSA Pharma.

Non-GAAP Financial Measures

To supplement Jazz Pharmaceuticals' financial results and guidance presented on a GAAP basis, the company uses certain non-GAAP adjusted income and adjusted net income financial measures. The company believes that these non-GAAP financial measures are helpful in understanding its past financial performance and potential future results, particularly in light of the effect of various acquisition and divestiture transactions effected by the company during 2012.  They are not meant to be considered in isolation or as a substitute for comparable GAAP measures, and should be read in conjunction with the consolidated financial statements prepared in accordance with GAAP. Jazz Pharmaceuticals' management regularly uses these supplemental non-GAAP financial measures internally to understand, manage and evaluate its business and make operating decisions. Compensation of executives is based in part on the performance of the company's business based on these non-GAAP measures. In addition, Jazz Pharmaceuticals believes that the use of these non-GAAP measures enhances the ability of investors to compare its results from period to period. Adjusted income and adjusted net income financial measures as used by Jazz Pharmaceuticals may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by the company's competitors and other companies.  The adjusted income from continuing operations and adjusted net income measures used in this press release represent GAAP income from continuing operations excluding revenue related to upfront and milestone payments, amortization of intangible assets, share-based compensation expense, purchase accounting inventory fair value step-up adjustments, transaction and integration costs, restructuring charges, change in fair value of contingent consideration, loss on extinguishment of debt, other non-cash items, and the income tax effects of these adjustments and acquisition restructuring activities. The adjusted income from discontinued operations measures used in this press release represent GAAP loss from discontinued operations excluding amortization of intangible assets, share-based compensation expense and purchase accounting inventory fair value step-up adjustments. 

This press release also includes, with respect to the company's 2012 financial guidance, the non-GAAP financial measures "adjusted gross margin percentage" and "adjusted combined selling, general and administrative and research and development expenses".  As used in this press release, "adjusted gross margin percentage" and "adjusted combined selling, general and administrative and research and development expenses" exclude from GAAP gross margin percentage and GAAP combined selling, general and administrative and research and development expenses, respectively, as applicable, share-based compensation expense, purchase accounting inventory fair value step-up adjustments, transaction and integration costs, restructuring charges and change in fair value of contingent consideration. The company believes that, similar to the presentation of adjusted net income and adjusted net income per diluted share, these non-GAAP financial measures are also helpful in understanding the company's 2012 financial guidance, particularly in light of the effect of various acquisition and divestiture transactions effected by the company during 2012. They are not meant to be considered in isolation or as a substitute for comparable GAAP measures, and should be read in conjunction with the consolidated financial statements prepared in accordance with GAAP. 

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals' future financial results and growth potential, including 2012 financial guidance, future product development and other statements that are not historical facts.  These forward-looking statements are based on Jazz Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with maintaining and increasing sales of and revenue from Xyrem, such as the potential introduction of generic competition and changed or increased regulatory restrictions on Xyrem, as well as similar risks related to effectively commercializing the company's other marketed products, including Erwinaze and Prialt; successfully integrating and growing Jazz Pharmaceuticals' combined business operations after the Azur Pharma merger and EUSA Pharma acquisition, which may be more difficult, time-consuming or costly than expected, particularly in light of the company's expanded international footprint; obtaining appropriate pricing and reimbursement for the company's products in an increasingly challenging environment; ongoing regulation and oversight by U.S. and foreign regulatory agencies; dependence on key customers and sole source suppliers; the company's ability to protect intellectual property rights with respect to its products; the difficulty and uncertainty of pharmaceutical product development and the uncertainty of clinical success and regulatory approval; and potential restrictions on the company's ability and flexibility to pursue future opportunities as a result of its substantial outstanding debt obligations; as well as risks related to future opportunities and plans, including the uncertainty of expected future financial performance and results; and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including in the Quarterly Report on Form 10-Q for the quarter ended June 30, 2012 and future filings and reports by the company, including the Quarterly Report on Form 10-Q for the quarter ended September 30, 2012. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.  

 JAZZ PHARMACEUTICALS PLC 

 CONDENSED CONSOLIDATED STATEMENTS OF INCOME 

 (In thousands, except per share amounts) 

 (Unaudited) 



Three Months Ended

September 30,


Nine Months Ended

September 30,


2012


2011


2012


2011

 Revenues: 








 Product sales, net 

$ 174,130


$ 72,216


$ 398,585


$ 185,583

 Royalties and contract revenues 

1,385


1,077


3,691


3,158

 Total revenues 

175,515


73,293


402,276


188,741

 Operating expenses: 








 Cost of product sales 

32,629


3,901


52,662


10,080

 Selling, general and administrative 

60,924


30,547


162,505


72,552

 Research and development 

6,920


3,279


13,200


10,356

 Intangible asset amortization 

19,742


1,862


43,444


5,586

 Total operating expenses 

120,215


39,589


271,811


98,574

 Income from operations 

55,300


33,704


130,465


90,167

 Interest expense, net 

(7,750)


(125)


(9,199)


(1,559)

 Foreign exchange and other 

(1,099)


-


(1,357)


-

 Loss on extinguishment of debt 

-


(1,097)


-


(1,097)

 Income from continuing operations before provision for income tax expense 

46,451


32,482


119,909


87,511

 Provision for income tax expense 

12,856


-


24,966


-

 Income from continuing operations 

33,595


32,482


94,943


87,511

 Loss from discontinued operations 

(386)


-


(6,908)


-

 Net income  

$  33,209


$ 32,482


$  88,035


$   87,511









Basic income (loss) per share:








    Income from continuing operations

$      0.59


$    0.77


$     1.69


$      2.12

    Loss from discontinued operations

(0.01)


-


(0.12)


-

    Net income

$      0.58


$    0.77


$     1.57


$      2.12

Diluted income (loss) per share:








    Income from continuing operations

$      0.56


$    0.69


$     1.59


$      1.88

    Loss from discontinued operations

(0.01)


-


(0.12)


-

    Net income

$      0.55


$    0.69


$     1.47


$      1.88









 Weighted-average ordinary shares used in per share computations: 








 Basic 

57,703


42,028


56,198


41,206

 Diluted 

60,883


47,241


59,846


46,577


















 JAZZ PHARMACEUTICALS PLC 

 SUMMARY OF PRODUCT SALES, NET 

 (In thousands) 

 (Unaudited) 



Three Months Ended

September 30,


Nine Months Ended

September 30,


2012


2011


2012


2011

Xyrem

$ 102,615


$ 62,547


$ 265,149


$ 161,503

Erwinaze/Erwinase (1)

31,652


-


37,660


-

Prialt (1)

5,413


-


20,491


-

Psychiatry:








    Luvox CR

11,605


9,669


31,634


24,080

    FazaClo LD (1)

6,370


-


17,905


-

    FazaClo HD (1)

3,057


-


8,979


-

Other (1)

13,418


-


16,767


-

Total

$ 174,130


$ 72,216


$ 398,585


$ 185,583

























(1)

Net sales for the three and nine months ended September 30, 2012 reported by Jazz Pharmaceuticals plc include net sales from the historic Azur Pharma business for the period from July 1, 2012 through September 30, 2012 and from January 18, 2012 through September 30, 2012, respectively, and net sales from the historic EUSA Pharma business for the period from July 1, 2012 through September 30, 2012 and from June 12, 2012 through September 30, 2012, respectively.   Net sales from women's health products are included in discontinued operations.




The following unaudited pro forma information represents the combined net product sales for the three and nine months ended September 30, 2012 and 2011, respectively, as if the merger with Azur Pharma, the acquisition of EUSA Pharma and disposition of the women's health business had each been completed on January 1, 2011:








SUMMARY OF PRODUCT SALES, NET (PRO FORMA)



(In thousands)



(Unaudited)














Three Months Ended

September 30,


Nine Months Ended

September 30,




2012


2011


2012


2011



Xyrem

$ 102,615


$ 62,547


$ 265,149


$ 161,503



Erwinaze/Erwinase

31,652


9,638


97,447


25,686



Prialt

5,413


4,984


20,830


14,827



Psychiatry:










     Luvox CR

11,605


9,669


31,634


24,080



     FazaClo LD

6,370


7,713


18,138


22,015



     FazaClo HD

3,057


2,322


9,109


5,538



Other

13,418


12,322


38,708


39,935



Total pro forma net sales

$ 174,130


$ 109,195


$ 481,015


$ 293,584











JAZZ PHARMACEUTICALS PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)






September 30,


December 31,


2012


2011

ASSETS




Current assets:




Cash and cash equivalents

$ 189,793


$ 82,076

Marketable securities

-


75,822

Accounts receivable

88,304


34,374

Inventories

30,300


3,909

Prepaid expenses

7,127


1,690

Other current assets

9,942


1,260

Assets held for sale

59,546


-

Total current assets

385,012


199,131

Property and equipment, net

6,671


1,557

Intangible assets, net

876,959


14,585

Goodwill

437,652


38,213

Other long-term assets

20,405


87

Total assets

$ 1,726,699


$ 253,573





LIABILITIES AND SHAREHOLDERS' EQUITY




Current liabilities:




Accounts payable

$ 20,535


$ 5,129

Accrued liabilities

123,632


34,783

Current portion of long-term debt

26,719


-

Purchased product rights liability

5,743


4,500

Liability under government settlement

-


7,320

Deferred revenue

1,943


1,138

Total current liabilities

178,572


52,870

Deferred revenue, non-current

7,129


7,915

Long-term debt, less current portion

435,631


-

Contingent consideration

36,200


-

Deferred tax liability

180,919


-

Other non-current liabilities

2,161


-

Total shareholders' equity

886,087


192,788

Total liabilities and shareholders' equity

$ 1,726,699


$ 253,573










JAZZ PHARMACEUTICALS PLC

RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED INFORMATION

CERTAIN LINE ITEMS

(In thousands, except per share amounts)

(Unaudited)














Three Months Ended


September 30, 2012


September 30, 2011


GAAP


Adjustment


Non-GAAP


GAAP


Adjustment


Non-GAAP

Total revenues

$ 175,515


$               -


$ 175,515


$ 73,293


$ (285)

(g)

$ 73,008

Cost of product sales

32,629


(10,771)

(a)

21,858


3,901


(201)

(c)

3,700

Selling, general and administrative

60,924


(9,275)

(b)

51,649


30,547


(8,130)

(h)

22,417

Research and development

6,920


(681)

(c)

6,239


3,279


(838)

(c)

2,441

Intangible asset amortization

19,742


(19,742)


-


1,862


(1,862)


-

Interest expense, net

7,750


(1,261)

(d)

6,489


125


-


125

Loss on extinguishment of debt

-


-


-


1,097


(1,097)


-

Provision for income tax expense

12,856


(3,263)

(e)

9,593


-


-


-

Income from continuing operations

33,595


44,993


78,588


32,482


11,843


44,325

Income (loss) from discontinued operations

(386)


3,372

(f)

2,986


-


-


-













Diluted income (loss) per share:












Income from continuing operations

$ 0.56




$ 1.29


$ 0.69




$ 0.94

Income (loss) from discontinued operations

(0.01)




0.05


-




-

Total

0.55




1.34


0.69




0.94













(a)

Purchase accounting inventory fair value step-up of $10,336, share-based compensation expense of $344 and restructuring expense of $91.

(b)

Share-based compensation expense of $5,330, restructuring charges of $1,542, transaction and integration costs of $1,503, and change in fair value of contingent consideration of $900.

(c)

Share-based compensation expense.

(d)

Non-cash interest expense primarily associated with debt discount and debt issuance costs.

(e)

Tax related to acquisition restructuring of $9,529 partially offset by the tax effect of non-GAAP pre-tax adjustments of $6,266.

(f)

Intangible asset amortization of $2,009, purchase accounting inventory fair value step-up of $1,106 and share-based compensation expense of $257.

(g)

Revenue related to upfront and milestone payments.

(h)

Transaction and integration costs of $5,974 and share-based compensation expense of $2,156.















JAZZ PHARMACEUTICALS PLC

RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED INFORMATION

CERTAIN LINE ITEMS

(In thousands, except per share amounts)

(Unaudited)














Nine Months Ended


September 30, 2012


September 30, 2011


GAAP


Adjustment


Non-GAAP


GAAP


Adjustment


Non-GAAP

Total revenues

$ 402,276


$               -


$ 402,276


$ 188,741


$ (854)

(g)

$ 187,887

Cost of product sales

52,662


(15,766)

(a)

36,896


10,080


(430)

(c)

9,650

Selling, general and administrative

162,505


(32,848)

(b)

129,657


72,552


(12,960)

(h)

59,592

Research and development

13,200


(1,718)

(c)

11,482


10,356


(2,342)

(c)

8,014

Intangible asset amortization

43,444


(43,444)


-


5,586


(5,586)


-

Interest expense, net

9,199


(1,569)

(d)

7,630


1,559


(394)

(d)

1,165

Loss on extinguishment of debt

-


-


-


1,097


(1,097)


-

Provision for income tax expense

24,966


(6,160)

(e)

18,806


-


-


-

Income from continuing operations

94,943


101,505


196,448


87,511


21,955


109,466

Income (loss) from discontinued operations

(6,908)


11,185

(f)

4,277


-


-


-













Diluted income (loss) per share:












Income from continuing operations

$ 1.59




$ 3.28


$ 1.88




$ 2.35

Income (loss) from discontinued operations

(0.12)




0.07


-




-

Total

1.47




3.35


1.88




2.35













(a)

Purchase accounting inventory fair value step-up of $14,676, share-based compensation expense of $999 and restructuring expense of $91.

(b)

Transaction and integration costs of $17,692, share-based compensation expense of $11,967, restructuring charges of $2,089 and change in fair value of contingent consideration of $1,100.

(c)

Share-based compensation expense.

(d)

Non-cash interest expense primarily associated with debt discount and debt issuance costs.

(e)

Tax related to acquisition restructuring of $15,379 partially offset by the tax effect of non-GAAP pre-tax adjustments of $9,219.

(f)

Intangible asset amortization of $7,571, purchase accounting inventory fair value step-up of $3,146 and share-based compensation expense of $468.

(g)

Revenue related to upfront and milestone payments.

(h)

Share-based compensation expense of $6,986 and transaction and integration costs of $5,974.




JAZZ PHARMACEUTICALS PLC

CONDENSED CONSOLIDATED STATEMENTS OF DISCONTINUED OPERATIONS

(In thousands)

(Unaudited)






Three Months Ended

September 30, 2012


Nine Months Ended

September 30, 2012





Product sales, net

$              8,086


$           19,277





Loss from discontinued operations

$                (386)


$           (6,908)






 JAZZ PHARMACEUTICALS PLC 

 RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED 2012 FINANCIAL GUIDANCE 

 (In millions, except per share amounts) 









 GAAP income from continuing operations 

$140 - 151

 Intangible asset amortization 

63

 Share-based compensation expense 

23-24

 Purchase accounting inventory fair value step-up 

17 - 18

 Transaction, integration and restructuring costs 

22 - 24

 Change in fair value of contingent consideration 

2

 Other non-cash expense 

3

 Income tax adjustments 

5-6

 Adjusted net income 

$280 - 286



 GAAP income from continuing operations per diluted share 

$2.34 - $2.49

 Adjusted net income per diluted share 

$4.65 - $4.75



 Shares used in computing per diluted share amounts 

60





SOURCE Jazz Pharmaceuticals, Inc.

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