Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

November 1, 2011

Date of Report (Date of earliest event reported)

 

 

JAZZ PHARMACEUTICALS, INC.

(Exact name of Registrant as specified in its charter)

 

 

 

Delaware   001-33500   05-0563787

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File No.)

 

(IRS Employer

Identification No.)

3180 Porter Drive, Palo Alto, California 94304

(Address of principal executive offices, including zip code)

(650) 496-3777

(Registrant’s telephone number, including area code)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 2.02. Results of Operations and Financial Condition.

On November 1, 2011, Jazz Pharmaceuticals, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2011. A copy of the press release is furnished as Exhibit 99.1 to this report.

The information in this Item 2.02 and in the press release furnished as Exhibit 99.1 to this current report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the press release furnished as Exhibit 99.1 to this current report shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Jazz Pharmaceuticals, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit

Number

  

Description

99.1    Press Release dated November 1, 2011


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

JAZZ PHARMACEUTICALS, INC.
By:  

/s/ Bruce C. Cozadd

  Bruce C. Cozadd
  Chairman and Chief Executive Officer

Date: November 1, 2011


EXHIBIT INDEX

 

Exhibit

Number

  

Description

99.1    Press Release dated November 1, 2011
Press Release

Exhibit 99.1

LOGO

Jazz Pharmaceuticals Announces Third Quarter 2011 Financial Results

— Total revenues increased to $73.3 million —

— Adjusted EPS of $0.94; GAAP EPS of $0.69 —

— Company increases full year 2011 sales and earnings guidance —

PALO ALTO, Calif., Nov 1, 2011 — Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced financial results for the third quarter of 2011.

Total revenues for the quarter ended September 30, 2011 were $73.3 million, compared to $44.8 million for the third quarter of 2010. Total revenues include net product sales, royalties and contract revenues.

Adjusted net income for the third quarter of 2011 was $44.3 million, or $0.94 per diluted share, compared to $17.2 million, or $0.41 per diluted share, for the third 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 the third quarter of 2011 was $32.5 million, or $0.69 per diluted share, compared to a GAAP net income of $13.2 million, or $0.32 per diluted share, for the third quarter of 2010. The company’s GAAP net income in the third quarter of 2011 included costs of $6.0 million associated with the proposed transaction with Azur Pharma Public Limited Company (formerly Azur Pharma Limited) announced in September and a loss on extinguishment of debt of approximately $1.1 million associated with prepayment of a term loan in July 2011.

Net sales of Xyrem® (sodium oxybate) increased significantly to $62.5 million for the third quarter of 2011, compared to net sales of $37.2 million for the third quarter of 2010. Net sales of once-daily Luvox CR® (fluvoxamine maleate) were $9.7 million for the third quarter of 2011, compared to $6.6 million for the prior year period.

“This strong quarter reflects the continued success of Xyrem as an important medical therapy for patients experiencing the two key symptoms of narcolepsy,” said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. “In the quarter, we also took a significant step forward towards strengthening our platform for growth and diversifying our product portfolio by entering into an agreement to combine with Azur Pharma. We continue to expect the transaction to close in the first quarter of 2012.”

Selling, general and administrative expenses and research and development expenses combined for the third quarter of 2011 were $33.8 million, compared to $25.4 million for the third quarter of 2010, reflecting higher legal and professional services expenses, primarily related to the Azur Pharma transaction, higher headcount related expenses, including stock-based compensation expense, and lower product development spending.

During the quarter, the company prepaid the entire remaining balance, or $33.3 million, of its long-term debt. Cash and marketable securities as of September 30, 2011 were $113 million.

2011 Financial Guidance

Jazz Pharmaceuticals is providing updated full year 2011 financial guidance as follows:

 

Total product sales

   $  261-268 million   

Xyrem

   $ 230 -235 million   

Luvox CR

   $ 31 - 33 million   


LOGO

 

SG&A and R&D combined expenses

   $ 114 118 million*

GAAP net income per diluted share

   $ 2.76 - 2.81

Adjusted net income per diluted share

   $ 3.45 - 3.50

 

* Includes estimated expenses associated with the Azur Pharma transaction.

A reconciliation of GAAP net income to adjusted net income and the related per diluted share amounts is included with this press release.

Conference Call Details

Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 1:30 p.m. PT/4:30 p.m. ET to provide a business update and to discuss 2011 third quarter results and updated 2011 financial guidance. The live webcast may be accessed from the Investors 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 866-700-7173 in the U.S., or 617-213-8838 outside the U.S., and entering passcode 78394935.

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

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.

Non-GAAP Financial Measures

To supplement our 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 our 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: revenue related to upfront and milestone payments, amortization of intangible assets, stock-based compensation, non-cash interest expense associated with a debt discount and debt issuance costs, loss on extinguishment of debt and costs associated with the proposed transaction with Azur Pharma.

 

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LOGO

“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’ growth potential and future financial performance, including 2011 financial guidance, and statements related to the anticipated consummation of the business combination transaction between Jazz Pharmaceuticals and Azur Pharma and the timing thereof. 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’ dependence on sales of Xyrem and its ability to increase sales of its Xyrem and Luvox CR products; competition, including potential generic competition; Jazz Pharmaceuticals’ dependence on single source suppliers and manufacturers; the ability of Jazz Pharmaceuticals to protect its intellectual property and defend its patents; regulatory obligations and oversight; Jazz Pharmaceuticals’ cash flow; Jazz Pharmaceuticals’ ability to complete the transaction with Azur Pharma on the proposed terms and schedule; and those risks detailed from time-to-time under the caption “Risk Factors” and elsewhere in Jazz Pharmaceuticals’ Securities and Exchange Commission (SEC) filings and reports, including in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 and preliminary proxy statement related to the Azur Pharma transaction, in each case filed with the SEC. 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.

Additional Information and Where to Find It

In connection with the proposed transaction, Jazz Pharmaceuticals and Azur Pharma have filed documents with the SEC, including the filing by Jazz Pharmaceuticals of a preliminary proxy statement relating to the proposed transaction and the filing by Azur Pharma of a registration statement on Form S-4 that includes the joint proxy statement/prospectus relating to the proposed transaction. After the registration statement has been declared effective by the SEC, a definitive joint proxy statement/prospectus will be filed with the SEC by Jazz Pharmaceuticals and Azur Pharma and mailed to Jazz Pharmaceuticals’ stockholders in connection with the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT ON FORM S-4 AND THE RELATED PRELIMINARY PROXY STATEMENT/PROSPECTUS AND, WHEN IT BECOMES AVAILABLE, THE DEFINITIVE PROXY STATEMENT/PROSPECTUS BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY, AZUR AND THE PROPOSED TRANSACTION. Investors and security holders may obtain free copies of these documents (when they are available) and other related documents filed with the SEC at the SEC’s web site at www.sec.gov, by directing a request to Jazz Pharmaceuticals’ Investor Relations department at Jazz Pharmaceuticals, Inc., Attention: Investor Relations, 3180 Porter Drive, Palo Alto, California 94304, or to Jazz Pharmaceuticals’ Investor Relations department at 650-496-2800 or by email to investorinfo@jazzpharma.com. Investors and security holders may obtain free copies of the documents filed with the SEC on Jazz Pharmaceuticals’ website at www.jazzpharmaceuticals.com under the heading “Investors” and then under the heading “SEC Filings.”

Jazz Pharmaceuticals and its directors and executive officers and Azur Pharma and its directors and executive officers may be deemed participants in the solicitation of proxies from the stockholders of Jazz Pharmaceuticals in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the proposed transaction is included in the proxy statement/prospectus described above. Additional information regarding the directors and executive officers of Jazz Pharmaceuticals is also included in Jazz Pharmaceuticals’ proxy statement for its 2011 Annual Meeting of Stockholders, which was filed with the SEC on April 12, 2011. These documents are available free of charge at the SEC’s web site at www.sec.gov and from Investor Relations at Jazz Pharmaceuticals as described above.

 

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LOGO

This communication does not constitute an offer to sell, or the solicitation of an offer to sell, or the solicitation of an offer to subscribe for or buy, any securities nor shall there be any sale, issuance or transfer of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

# # #

Contact

Ami Knoefler

Executive Director

Investor Relations & Corporate Communications

Jazz Pharmaceuticals, Inc.

ami.knoefler@jazzpharma.com

650-496-2947

 

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LOGO

JAZZ PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

(In thousands, except per share amounts)

(Unaudited)

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2011     2010     2011     2010  

Revenues:

        

Product sales, net

   $ 72,216      $ 43,838      $ 185,583      $ 117,649   

Royalties

     792        630        2,304        1,909   

Contract revenues

     285        285        854        854   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

     73,293        44,753        188,741        120,412   

Operating expenses:

        

Cost of product sales

     3,901        3,091        10,080        8,775   

Selling, general and administrative

     30,547        18,040        72,552        51,926   

Research and development

     3,279        7,317        10,356        21,494   

Intangible asset amortization

     1,862        1,862        5,586        5,963   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     39,589        30,310        98,574        88,158   
  

 

 

   

 

 

   

 

 

   

 

 

 

Income from operations

     33,704        14,443        90,167        32,254   

Interest income and other, net

     4        (3     6        3   

Interest expense

     (129     (1,197     (1,565     (11,651

Loss on extinguishment of debt

     (1,097     —          (1,097     (12,287
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income

   $ 32,482      $ 13,243      $ 87,511      $ 8,319   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income per share:

        

Basic

   $ 0.77      $ 0.34      $ 2.12      $ 0.24   
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

   $ 0.69      $ 0.32      $ 1.88      $ 0.22   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average common shares used in computing net income per share:

        

Basic

     42,028        38,965        41,206        35,294   
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

     47,241        41,737        46,577        38,233   
  

 

 

   

 

 

   

 

 

   

 

 

 

JAZZ PHARMACEUTICALS, INC.

SUMMARY OF PRODUCT SALES, NET

(In thousands)

(Unaudited)

 

     Three Months Ended
September 30,
     Nine Months Ended
September 30,
 
     2011      2010      2011      2010  

Xyrem

   $ 62,547       $ 37,231       $ 161,503       $ 99,699   

Luvox CR

     9,669         6,607         24,080         17,950   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 72,216       $ 43,838       $ 185,583       $ 117,649   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

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LOGO

JAZZ PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

 

     September 30,      December 31,  
     2011      2010  
ASSETS      

Current assets:

     

Cash and cash equivalents

   $ 101,215       $ 44,794   

Marketable securities

     12,133         —     

Restricted cash

     —           400   

Accounts receivable, net of allowances

     31,428         22,081   

Inventories

     4,297         5,046   

Prepaid expenses

     2,535         1,858   

Other current assets

     532         279   
  

 

 

    

 

 

 

Total current assets

     152,140         74,458   

Property and equipment, net

     930         690   

Intangible assets, net

     16,447         22,033   

Goodwill

     38,213         38,213   

Other long-term assets

     83         335   
  

 

 

    

 

 

 

Total assets

   $ 207,813       $ 135,729   
  

 

 

    

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

     

Current liabilities:

     

Accounts payable

   $ 8,463       $ 3,049   

Accrued liabilities

     35,834         23,572   

Purchased product rights liability

     4,875         4,500   

Liability under government settlement

     7,225         4,128   

Revolving credit facility

     —           7,350   

Current portion of long-term debt

     —           16,064   

Deferred revenue

     1,138         1,273   
  

 

 

    

 

 

 

Total current liabilities

     57,535         59,936   

Purchased product rights liability, non-current

     750         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

     8,199         9,053   

Total stockholders’ equity

     141,329         30,551   
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 207,813       $ 135,729   
  

 

 

    

 

 

 

 

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LOGO

JAZZ PHARMACEUTICALS, INC.

RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES

(In thousands, except per share amounts)

(Unaudited)

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2011     2010     2011     2010  

GAAP net income

   $ 32,482      $ 13,243      $ 87,511      $ 8,319   

Add:

        

Intangible asset amortization

     1,862        1,862        5,586        5,963   

Stock-based compensation expense

     3,195        2,177        9,758        5,969   

Non-cash interest expense

     —          252        394        2,175   

Loss on extinguishment of debt

     1,097        —          1,097        12,287   

Azur Pharma transaction related costs

     5,974        —          5,974        —     

Deduct:

        

Contract revenues

     (285     (285     (854     (854
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income

   $ 44,325      $ 17,249      $ 109,466      $ 33,859   
  

 

 

   

 

 

   

 

 

   

 

 

 

GAAP net income per diluted share

   $ 0.69      $ 0.32      $ 1.88      $ 0.22   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income per diluted share

   $ 0.94      $ 0.41      $ 2.35      $ 0.89   
  

 

 

   

 

 

   

 

 

   

 

 

 

Shares used in computing GAAP and adjusted net income per diluted share amounts

     47,241        41,737        46,577        38,233   

JAZZ PHARMACEUTICALS, INC.

RECONCILIATION OF GAAP TO NON-GAAP 2011 FINANCIAL GUIDANCE

(In millions, except per share amounts)

 

GAAP net income

   $128-131

Add:

  

Intangible asset amortization

   7

Stock-based compensation expense

   13

Non-cash interest expense and loss on extinguishment of debt

   2

Azur Pharma transaction related costs

   10-11

Deduct:

  

Contract revenues

   (1)
  

 

Adjusted net income

   $160-163
  

 

GAAP net income per diluted share

   $2.76-2.81
  

 

Adjusted net income per diluted share

   $3.45-3.50
  

 

Shares used in computing GAAP and adjusted net income per diluted share amounts

   46-47

 

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