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Jazz Pharmaceuticals Reports 2011 Full Year and Fourth Quarter Financial Results


News provided by

Jazz Pharmaceuticals, Inc.

27 Feb, 2012, 22:03 GMT

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DUBLIN, February 27, 2012 /PRNewswire/ --

-- Xyrem Achieves Record Annual Sales of $233 Million for 2011 --

-- 2011 Product Sales for Azur Pharma Announced --

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for Jazz Pharmaceuticals, Inc. for the full year and fourth quarter ended December 31, 2011, and provided selected 2011 financial results for Azur Pharma.

"2011 was an exceptional year, as our targeted investments in Xyrem continue to yield strong volume growth," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals plc. "As we look ahead into 2012, the recent business combination broadens our product portfolio, further strengthens our team and provides an efficient platform for growth as we pursue our mission to improve patients' lives."

A separate Form 10-K, including 2011 financial statements, will be filed shortly with the Securities and Exchange Commission for each of Jazz Pharmaceuticals, Inc. and the former Azur Pharma.

Jazz Pharmaceuticals, Inc. Results

As announced on January 18, 2012, Jazz Pharmaceuticals, Inc. and Azur Pharma Public Limited Company combined to create Jazz Pharmaceuticals plc. The historical financial results discussed below are those of Jazz Pharmaceuticals, Inc.

Total revenues for the full year ended December 31, 2011 were $272.3 million, an increase of 57 percent, compared to total revenues of $173.8 million for the year ended December 31, 2010. Total revenues for the fourth quarter of 2011 were $83.5 million, compared to $53.4 million for the fourth quarter of 2010. Total revenues for both the year and the quarter included net product sales, royalties and contract revenues.

Adjusted net income for 2011 was $164.9 million, or $3.52 per diluted share, compared to 2010 adjusted net income of $61.0 million, or $1.55 per diluted share. Adjusted net income for the fourth quarter of 2011 was $55.4 million, or $1.17 per diluted share, compared to $27.2 million, or $0.63 per diluted share, for the fourth quarter of 2010. A reconciliation of GAAP net income to adjusted net income and the related per diluted share amounts is included with this press release.

GAAP net income for 2011 was $125.0 million, or $2.67 per diluted share, compared to $32.8 million, or $0.83 per diluted share for 2010. GAAP net income for the fourth quarter of 2011 was $37.5 million, or $0.79 per diluted share, compared to GAAP net income of $24.5 million, or $0.56 per diluted share for the fourth quarter of 2010.

Xyrem® (sodium oxybate) net sales for 2011 increased 64 percent to $233.3 million, compared to $142.6 million in 2010. Net sales of Xyrem increased 67 percent to $71.8 million in the fourth quarter of 2011, compared to $42.9 million in the fourth quarter of 2010.

Luvox CR® (fluvoxamine maleate) net sales for 2011 increased 21 percent to $33.2 million, compared to $27.4 million in 2010. Net sales of Luvox CR for the fourth quarter of 2011 were $9.1 million, compared to $9.4 million in the fourth quarter of 2010. Both fourth quarter and full year 2010 net sales of Luvox CR included $2.0 million of revenue recorded as a result of a change in the timing of when revenue is recognized; the profit associated with this change of $1.3 million is excluded from the fourth quarter and full year 2010 adjusted net income.

Selling, general and administrative expenses and research and development expenses combined for 2011 were $123.1 million, compared to $94.6 million in 2010. Selling, general and administrative and research and development expenses for the fourth quarter of 2011 were $40.1 million, compared to $21.2 million in the same period of 2010, reflecting higher headcount expenses including stock-based compensation expense; higher legal and professional expenses primarily related to the transaction; and lower product development spending. Operating expenses in 2011 included $11.2 million in costs associated with the business combination, of which $5.3 million was recorded in the fourth quarter of 2011. Both fourth quarter and full year 2011 operating expenses also included $7.3 million in stock-based compensation expenses associated with the modification of stock options in connection with the transaction.

Cash, cash equivalents and marketable securities for Jazz Pharmaceuticals, Inc. as of December 31, 2011 were $157.9 million.

Azur Pharma Results

For the year ended December 31, 2011, Azur Pharma's net product sales were $94.2 million. Cash and cash equivalents for Azur Pharma as of December 31, 2011 were $80.3 million.

                       AZUR PHARMA PUBLIC LIMITED COMPANY
                          SUMMARY OF PRODUCT SALES, NET
                                 (In thousands)
                                   (Unaudited)

                   Three Months Ended December 31,     Year Ended December  31,
                       2011            2010             2011           2010
    Prialt (1)      $ 5,773         $ 4,817          $ 20,600       $ 12,852
    FazaClo LD        8,090           9,060            30,105         34,555
    FazaClo HD        3,143           1,566             8,681          2,780
    Women's Health
     and other        9,226           8,199            34,857         33,012
    Total          $ 26,232        $ 23,642          $ 94,243       $ 83,199

    (1) Azur Pharma acquired the rights to Prialt in May 2010.

Conference Call Details

Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 9:30 p.m. GMT/4:30 p.m. EST to provide a business update and to discuss 2011 full year and fourth quarter results. The live webcast may be accessed from the Investors section of the company's website at http://www.jazzpharmaceuticals.com. Investors may participate in the conference call by dialing 1-888-396-2356 in the U.S., or +1-617-847-8709 outside the U.S., and entering passcode 70752389.

An archived version of the webcast will be available for at least one week on the investors section of the Jazz Pharmaceuticals' website at http://www.jazzpharmaceuticals.com.

About Jazz Pharmaceuticals

Jazz Pharmaceuticals plc is a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing products that address unmet medical needs. The company has a diverse portfolio of products in the areas of narcolepsy, severe chronic pain, psychiatry and women's health. The company's marketed products in these areas include: Xyrem® (sodium oxybate), Prialt® (ziconotide intrathecal infusion), FazaClo® (clozapine USP) HD and LD, Luvox CR® (fluvoxamine maleate) and Elestrin® (estradiol gel 0.06%).

Non-GAAP Financial Measures

To supplement financial results and financial guidance presented on a GAAP basis, we use the non-GAAP measures adjusted net income and adjusted net income per diluted share. We believe these non-GAAP financial measures are helpful in understanding our past financial performance and our potential future results. 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. Our management regularly uses these supplemental non-GAAP financial measures internally to understand, manage and evaluate our business and make operating decisions. Compensation of our employees is based in part on the performance of our business based on these non-GAAP measures. In addition, we believe that the use of these non-GAAP measures enhances the ability of investors to compare our results from period to period. Investors should note that adjusted net income and adjusted net income per diluted share, as used by Jazz Pharmaceuticals, may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by our competitors and other companies. Adjusted net income and adjusted net income per diluted share exclude from the comparable GAAP measures: contract revenues related to previously deferred upfront and milestone payments, the gross margin impact of a change in the timing of when Luvox CR revenue is recognized, stock-based compensation, amortization of intangible assets, costs associated with the business combination between Jazz Pharmaceuticals, Inc. and Azur Pharma, loss on extinguishment of debt and non-cash interest expense associated with a debt discount and debt issuance costs.

"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 relating to Jazz Pharmaceuticals plc's future financial performance, including future performance and potential sales and earnings growth, and statements related to potential future product acquisitions. These forward-looking statements are based on Jazz Pharmaceuticals plc's 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 associated with business combination transactions, such as the risk that the historic businesses of Jazz Pharmaceuticals, Inc. and Azur Pharma will not be integrated successfully or that such integration may be more difficult, time-consuming or costly than expected; risks related to future opportunities and plans, including uncertainty of the expected financial performance and results; assumptions in the tax provisions for Jazz Pharmaceuticals plc; disruption from the merger transaction and related integration efforts, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers; the allocation of the acquisition price in the merger to the net assets acquired in accordance with applicable accounting rules and methodologies; and the possibility that if Jazz Pharmaceuticals plc does not achieve the perceived benefits of the merger transaction as rapidly or to the extent anticipated by financial analysts or investors, the market price of the ordinary shares could decline, as well as other risks related to the business, including dependence on sales of Xyrem and the ability to increase sales of products; competition, including potential generic competition; dependence on single source suppliers and manufacturers; the ability of to protect intellectual property and defend patents; regulatory obligations and oversight; the ability of Jazz Pharmaceuticals plc to successfully identify and acquire, in-license or develop additional products or product candidates to grow its business; cash flow; and those other risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's or Jazz Pharmaceuticals, Inc.'s SEC filings and reports, including Jazz Pharmaceuticals Inc.'s definitive proxy statement related to its stockholders' meeting held on December 12, 2011. 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, INC.
                   CONDENSED CONSOLIDATED STATEMENTS OF INCOME
                    (In thousands, except per share amounts)
                                   (Unaudited)

                              Three Months Ended               Year Ended 
                                 December 31,                 December 31,
                             2011            2010          2011          2010
    Revenues:
     Product sales, net   $ 80,935         $ 52,357    $ 266,518     $ 170,006
     Royalties and
     contract revenues       2,601            1,012        5,759         3,775
      Total revenues        83,536           53,369      272,277       173,781
    Operating expenses:
     Cost of product
     sales                   3,862            4,784       13,942        13,559
     Selling, general
     and administrative     36,384           17,070      108,936        68,996
     Research and
     development             3,764            4,118       14,120        25,612
     Intangible asset
     amortization            1,862            1,862        7,448         7,825
     Total operating
     expenses               45,872           27,834      144,446       115,992
    Income from
    operations              37,664           25,535      127,831        57,789
     Interest income
     and other, net             69                1           75             4
     Interest expense         (110)          (1,077)      (1,675)      (12,728)
     Loss on
     extinguishment of
     debt                     (150)               -       (1,247)      (12,287)
    Net income            $ 37,473         $ 24,459    $ 124,984      $ 32,778

    Net income per share:
     Basic                  $ 0.88           $ 0.62       $ 3.01        $ 0.90
     Diluted                $ 0.79           $ 0.56       $ 2.67        $ 0.83

    Weighted-average
    common shares used
    in computing net
    income per share:
     Basic                  42,367           39,456       41,499        36,343
     Diluted                47,451           43,405       46,798        39,411
                          JAZZ PHARMACEUTICALS, INC.
                         SUMMARY OF PRODUCT SALES, NET
                                (In thousands)
                                  (Unaudited)

                Three Months Ended December 31,     Year Ended December 31,
                     2011                2010         2011           2010
    Xyrem         $ 71,845            $ 42,931     $ 233,348      $ 142,630
    Luvox CR         9,090               9,426        33,170         27,376
    Total         $ 80,935            $ 52,357     $ 266,518      $ 170,006
                           JAZZ PHARMACEUTICALS, INC.
                      CONDENSED CONSOLIDATED BALANCE SHEETS
                                 (In thousands)
                                   (Unaudited)

                                                    December 31,     December 31,
                                                        2011             2010
    ASSETS
    Current assets:
     Cash and cash equivalents                       $ 82,076         $ 44,794
     Marketable securities                             75,822                -
     Restricted cash                                        -              400
     Accounts receivable, net of allowances            34,374           22,081
     Inventories                                        3,909            5,046
     Prepaid expenses                                   1,690            1,858
     Other current assets                               1,260              279
     Total current assets                             199,131           74,458
    Property and equipment, net                         1,557              690
    Intangible assets, net                             14,585           22,033
    Goodwill                                           38,213           38,213
    Other long-term assets                                 87              335
     Total assets                                   $ 253,573        $ 135,729

    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:
     Accounts payable                                 $ 5,129          $ 3,049
     Accrued liabilities                               34,783           23,572
     Liability under government settlement              7,320            4,128
     Purchased product rights liability                 4,500            4,500
     Revolving credit facility                              -            7,350
     Current portion of long-term debt                      -           16,064
     Deferred revenue                                   1,138            1,273
     Total current liabilities                         52,870           59,936
    Purchased product rights liability,
    non-current                                             -            4,500
    Liability under government settlement,
    non-current                                             -            6,978
    Long-term debt, less current portion                    -           24,629
    Deferred rent                                           -               82
    Deferred revenue, non-current                       7,915            9,053
    Total stockholders' equity                        192,788           30,551
    Total liabilities and stockholders' equity      $ 253,573        $ 135,729
                           JAZZ PHARMACEUTICALS, INC.
              RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES
                    (In thousands, except per share amounts)
                                   (Unaudited)

                              Three Months Ended                Year Ended 
                                  December 31,                 December 31,
                              2011            2010          2011          2010

    GAAP net income         $ 37,473       $ 24,459      $ 124,984     $ 32,778
    Add:
     Intangible asset
     amortization              1,862          1,862          7,448        7,825
     Stock-based
     compensation
     expense                  10,946          2,250         20,704        8,219
     Non-cash interest
     expense                       -            231            394        2,406
     Loss on extinguishment
     of debt                     150              -          1,247       12,287
     Transaction and
     integration costs         5,271              -         11,245            -
    Deduct:
     Contract revenues          (284)          (284)        (1,138)      (1,138)
     Luvox CR revenue
     recognition timing
     change                        -         (1,345)             -       (1,345)
    Adjusted net income     $ 55,418       $ 27,173      $ 164,884     $ 61,032

    GAAP net income per
    diluted share             $ 0.79         $ 0.56         $ 2.67       $ 0.83
    Adjusted net income
    per diluted share         $ 1.17         $ 0.63         $ 3.52       $ 1.55

    Shares used in
    computing GAAP and
    adjusted net income
    per diluted share
    amounts                   47,451         43,405         46,798       39,411

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