Navigation Links
Jazz Pharmaceuticals Announces Third Quarter 2009 Financial Results
Date:11/5/2009

PALO ALTO, Calif., Nov. 5 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced financial results for the third quarter ended September 30, 2009.

Total revenues for the third quarter of 2009 were $30.8 million, compared to $17.7 million for the quarter ended September 30, 2008. XYREM® (sodium oxybate) oral solution net sales for the third quarter of 2009 were $25.0 million, compared to $14.2 million for the third quarter of 2008, and represented a 12% sequential increase over net sales of $22.4 million for the second quarter of 2009. Net sales of once-daily LUVOX CR® (fluvoxamine maleate) extended-release capsules were $5.0 million for the third quarter of 2009, compared to $2.0 million for the third quarter 2008, and represented a 20% sequential increase over net sales of $4.1 million for the second quarter of 2009. Total revenues for the third quarter of 2009 also included $0.8 million in royalties and contract revenue.

"Our sales team delivered another solid quarter for us with record numbers of XYREM and LUVOX CR prescriptions and net sales" said Bob Myers, President of Jazz Pharmaceuticals.

Research and development expenses for the third quarter of 2009 were $7.6 million, compared to $12.1 million for the third quarter of 2008. This reduction from $11.2 million for the second quarter of 2009 was primarily due to the completion of the second Phase III pivotal clinical efficacy trial for JZP-6, sodium oxybate for the treatment of fibromyalgia, in June of 2009. Jazz Pharmaceuticals expects to submit a New Drug Application for JZP-6 by the end of 2009.

Jazz Pharmaceuticals' net loss for the third quarter of 2009 was $1.7 million, compared to a net loss of $28.8 million for the third quarter of 2008.

Jazz Pharmaceuticals is increasing its full-year 2009 guidance for XYREM and LUVOX CR net sales, and tightening its guidance for R&D expenses:



                             Prior Guidance       Updated Guidance
                             --------------       ----------------
    - Total revenues      $112 - 122 million      $122 - 127 million
    - XYREM net sales     $85  -  90 million      $92  -  95 million
    - LUVOX CR net sales  $15  -  18 million      $17  -  19 million
    - Contract revenues
       and royalties      $12  -  14 million      ~ $13 million
    - R&D expenses        $35  -  45 million      $36  -  40 million



"We have made impressive strides in transforming our business in 2009," said Bruce Cozadd, Chairman and Chief Executive Officer of Jazz Pharmaceuticals. "In the first nine months of 2008, we had net product sales of $45.8 million and an operating loss of $118.6 million. In the first nine months of 2009, we achieved net product sales of $77.8 million and operating income of $4.5 million. Our commercial business continues to grow and we look forward to submitting our NDA for JZP-6 next month."

Jazz Pharmaceuticals will host an investor conference call and live audio webcast to give a company update, as well as to discuss financial results and guidance, today (November 5, 2009) commencing at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The live webcast may be accessed from the Investors section of the Jazz Pharmaceuticals 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 1-866-825-1692 in the U.S., or 1-617-213-8059 outside the U.S., and entering passcode 25459996.

An archived version of the webcast will be available through November 19, 2009. This replay can be accessed from the Investors section of the Jazz Pharmaceuticals' website at www.JazzPharmaceuticals.com, or by calling 888-286-8010 in the U.S., or 617-801-6888 outside the U.S., and entering passcode 83883148.

About Jazz Pharmaceuticals, Inc.

Jazz Pharmaceuticals is a specialty pharmaceutical company focused on identifying, developing and commercializing innovative products to meet unmet medical needs in neurology and psychiatry. For further information see www.JazzPharmaceuticals.com.

"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' ability to appropriately grow net product sales, the expected New Drug Application submission date for the JZP-6 product candidate, and Jazz Pharmaceuticals' full-year 2009 guidance. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Jazz Pharmaceuticals' 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 related to: Jazz Pharmaceuticals' ability to increase sales of XYREM and LUVOX CR; Jazz Pharmaceuticals' dependence on single source suppliers and manufacturers; the uncertain and time-consuming regulatory approval process for JZP-6; Jazz Pharmaceuticals' cash flow estimates; Jazz Pharmaceuticals' ability to use its net operating losses to offset taxes; competition; the holders of Jazz Pharmaceuticals' senior secured notes attempting to accelerate the notes as a result of past events of default or Jazz Pharmaceuticals' inability to comply with the terms of the agreement governing the senior secured notes on an ongoing basis; Jazz Pharmaceuticals' future financial performance and financial position; and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals' Securities and Exchange Commission filings and reports, including in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2009 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on August 14, 2009. 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.
                   CONSOLIDATED STATEMENTS OF OPERATIONS
                  (In thousands, except per share amounts)
                                (Unaudited)

                                   Three Months
                                  Ended September   Nine Months Ended
                                        30,            September 30,
                                 ----------------   -----------------
                                   2009      2008      2009       2008
                                   ----      ----      ----       ----
     Revenues:
      Product sales, net        $29,992   $17,022   $77,789    $45,757
      Royalties, net                532       440     1,522      1,308
      Contract revenues             285       284    10,854        854
                                    ---       ---    ------        ---
         Total revenues          30,809    17,746    90,165     47,919
     Operating expenses:
      Cost of product sales       2,338     5,525     6,856     10,619
      Research and development    7,644    12,149    30,244     55,274
      Selling, general
      and administrative         15,061    24,329    42,934     91,218
      Amortization of
      intangible assets           2,057     3,487     5,611      9,454
                                  -----     -----     -----      -----
       Total operating expenses  27,100    45,490    85,645    166,565
                                 ------    ------    ------    -------
     Income (loss)
      from operations             3,709   (27,744)    4,520   (118,646)
      Interest income                 2       353        29      1,700
      Interest expense           (5,384)   (5,355)  (17,034)   (14,377)
      Other income
      (expense), net                  1        19        (4)         6
      Gain on sale of
       product rights                 -     3,918         -      3,918
                                      -     -----         -      -----
     Net loss                   $(1,672) $(28,809) $(12,489) $(127,399)
                                =======  ========  ========  =========

     Net loss per share:
       Basic and diluted         $(0.05)   $(1.07)   $(0.42)    $(5.12)
                                 ======    ======    ======     ======

    Weighted-average common
     shares used in computing
     net loss per share:
       Basic and diluted         30,895    27,025    29,635     24,895
                                 ======    ======    ======     ======




                     JAZZ PHARMACEUTICALS, INC.
                   SUMMARY OF PRODUCT SALES, NET
                           (In thousands)
                            (Unaudited)

                                  Three Months    Nine Months
                                     Ended           Ended
                                  September 30,   September 30,
                                 --------------  --------------
                                   2009    2008    2009    2008
                                   ----    ----    ----    ----
    Xyrem                       $25,038 $14,234 $65,119 $37,980
    Luvox CR                      4,954   1,957  12,670   2,671
    Antizol and Antizol-Vet (1)       -     831       -   5,106
                                      -     ---       -   -----
    Total                       $29,992 $17,022 $77,789 $45,757
                                ======= ======= ======= =======

     (1) The Company sold its rights to and interests in Antizol and
         Antizol-Vet in August 2008.




                            JAZZ PHARMACEUTICALS, INC.
                       CONDENSED CONSOLIDATED BALANCE SHEETS
                                  (In thousands)
                                    (Unaudited)
                                                    September 30, December 31,
                                                           2009         2008
                                                           ----         ----
                         ASSETS
    Current assets:
      Cash and cash equivalents                          $12,230      $24,903
      Restricted cash                                        950        1,913
      Marketable securities                                    -        1,004
      Accounts receivable                                  9,202        6,643
      Inventories                                          4,532        4,788
      Prepaid expenses                                     1,969        2,366
      Other current assets                                   261        2,382
                                                             ---        -----
        Total current assets                              29,144       43,999
    Property and equipment, net                            1,444        2,514
    Intangible assets, net                                31,915       32,526
    Goodwill                                              38,213       38,213
    Other long-term assets                                 1,456          246
                                                           -----          ---
        Total assets                                    $102,172     $117,498
                                                        ========     ========

         LIABILITIES AND STOCKHOLDERS' DEFICIT
    Current liabilities:
      Accounts payable                                    $5,240       $5,736
      Accrued liabilities                                 21,370       19,024
      Line of credit                                       3,000        3,875
      Senior secured notes                                     -      118,534
      Purchased product rights liability                   6,000       14,000
      Deferred revenue                                     2,500       12,322
                                                           -----       ------
        Total current liabilities                         38,110      173,491
    Deferred rent                                              7            -
    Purchased product rights liability, noncurrent        10,000            -
    Deferred revenue, noncurrent                          10,476       11,330
    Liability under government settlement,
     noncurrent                                           10,658       13,063
    Senior secured notes                                 115,363            -
    Common stock subject to repurchase                         -       12,492
    Total stockholders' deficit                          (82,442)     (92,878)
                                                         -------      -------
    Total liabilities and stockholders' deficit         $102,172     $117,498
                                                        ========     ========



SOURCE Jazz Pharmaceuticals, Inc.


'/>"/>
SOURCE Jazz Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
2. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
3. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
4. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
5. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
6. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
7. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
8. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
9. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
10. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
11. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/5/2016)... Eisai Inc. announced today new analyses and ... of the American Epilepsy Society (AES). ... adjunctive therapy for the treatment of partial onset seizures ... generalized tonic-clonic seizures (PGTC) in patients with epilepsy who ... Important Safety Information for FYCOMPA, including Boxed WARNING for ...
(Date:12/5/2016)... , Dec 5, 2016 Research and ... and Pregnancy Rapid Test Market Size, Share, Development, Growth and Demand ... ... The global female fertility and pregnancy rapid test market is ... global Female fertility and pregnancy rapid test market is witnessing high ...
(Date:12/5/2016)... AVIV, Israel , December 5, 2016 ... to identifying, in-licensing and developing promising therapeutic candidates, presents positive ... for BL-8040, the Company,s leading oncology platform at the ongoing ... in San Diego, California . ... , , ...
Breaking Medicine Technology:
(Date:12/5/2016)... ... 06, 2016 , ... For many years, Andrew G. Zubinas has ... The beauty of the Lithuanian language and its poetry inspired him in ... Zubinas lyrically explores all aspects of a living, breathing forest where nothing ever stays ...
(Date:12/5/2016)... ... December 05, 2016 , ... “Epilepsy ... through tomorrow, December 6th, sparks a conversation about epilepsy, bearing down on the ... 26 people will be diagnosed with epilepsy within their lifetime. With such a ...
(Date:12/5/2016)... Reading, PA (PRWEB) , ... December 05, 2016 , ... ... partner in the United States and Canada for distribution of their natural fruits ... Hansen colors line is an exciting addition to our Life Sciences product portfolio,” ...
(Date:12/5/2016)... ... December 05, 2016 , ... ... Partners ("GPP") portfolio company, today announced it has acquired the assets of ... was previously a subsidiary of Chiltern International and focuses on clinical trial ...
(Date:12/5/2016)... (PRWEB) , ... December 05, 2016 , ... The new ... the individual looking to buy neoprene knee sleeves for lifting and any ... design focuses heavily on two main aspects to provide a higher quality knee sleeve ...
Breaking Medicine News(10 mins):