EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

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                    News Release

 

APP PHARMACEUTICALS REPORTS 2008 SECOND

QUARTER NET REVENUES OF $198 MILLION,

OPERATING INCOME OF $53 MILLION

Second Quarter Net Revenues Increased 24 percent, Income from Operations Grew 31 percent

SCHAUMBURG, Illinois July 31, 2008 – APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today reported financial results for the second quarter and six months ended June 30, 2008. As a result of the separation of Abraxis BioScience from APP Pharmaceuticals in the fourth quarter of 2007, APP’s business is reported, for all periods presented, on a continuing operations basis.

Second Quarter 2008 Financial Results

Net revenues increased 24 percent to $197.9 million, compared with $159.3 million in the second quarter of 2007. Gross profit increased to $94.1 million, compared with $80.2 million in the second quarter of 2007. Excluding $4.2 million for amortization of purchased products, gross profit was $98.3 million, or 50 percent of net revenues, compared with $84.3 million or 53 percent of net revenues, in the second quarter of 2007.

Total operating expenses were $40.9 million, compared with $39.6 million in the 2007 second quarter. Research and development expenses were $13.8 million compared with $12.7 million in last year’s second quarter, including costs associated with the technology transfer and start-up of the Puerto Rico manufacturing facility. SG&A expenses were $21.2 million, or 11 percent of net revenues, compared with $22.7 million, or 14 percent of net revenues, in the prior year second quarter.

Income from operations increased 31 percent to $53.3 million compared with $40.6 million in the 2007 second quarter. Net interest expense was $13.5 million compared with $4.4 million in the last year’s second quarter, primarily reflecting the increase in borrowing following the separation of Abraxis Bioscience, that was completed in November 2007.

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APP Pharmaceuticals, Inc

2008 Second Quarter Financial Results

Net income was $23.9 million, or $0.15 per diluted share, compared with second quarter 2007 income from continuing operations, net of tax, of $22.8 million or $0.14 per diluted share on a continuing operations basis.

The company reported adjusted income from continuing operations of $38.5 million, or $0.24 per diluted share, compared with $36.3 million, or $0.23 per diluted share, in the second quarter of 2007, which in each case excludes Puerto Rico facility pre-launch costs, amortization expense, non-cash stock compensation expense, separation, merger and other non-recurring costs (see table at the end of this release).

“In the second quarter, solid revenue growth across our product categories led to our strong financial performance,” said Tom Silberg, APP Pharmaceuticals’ president and chief executive officer. “We have revised upward our 2008 financial guidance to reflect strong second quarter results as well as positive trends in our Critical Care and Anesthetic/Analgesic products.”

First Six Months of 2008 Financial Results

Net revenues increased 15 percent to $346.0 million, compared with $299.6 million for the first six months of 2007. Gross profit was $164.2 million compared with $145.6 million, in the first six months of 2007. Excluding $8.3 million for amortization of purchased products, gross profit was $172.5 million, or 50 percent of net revenues, compared with $153.9 million or 51 percent of net revenues, in the first half of 2007.

Total operating expenses were $78.5 million, compared with $75.8 million in the comparable 2007 period. Research and development expenses were $26.2 million compared with $22.6 million in first six months of last year, including Puerto Rico technology transfer costs. SG&A expenses were $42.2 million or 12 percent of net revenues, compared with $44.7 million or 15 percent of net revenues, in the prior year six month period.

Income from operations increased 23 percent to $85.7 million compared with $69.8 million in the 2007 six month period. Net interest expense was $29.3 million compared with $8.0 million in the first six months of last year, primarily reflecting the increase in borrowing following the Abraxis Bioscience separation.


APP Pharmaceuticals, Inc

2008 Second Quarter Financial Results

Net income, for the six months ending June 2008, was $33.0 million, or $0.20 per diluted share, versus income from continuing operations, net of tax, of $36.4 million, or $0.23 per diluted share.

The company reported adjusted net income from continuing operations of $60.5 million, or $0.38 per diluted share, compared with $62.6 million, or $0.39 per diluted share, which in each case excludes Puerto Rico facility pre-launch costs, amortization expense, non-cash stock compensation expense, separation, merger and other non-recurring costs (see table at the end of this release).

APP currently has approximately 65 product candidates in various stages of development, including 25 ANDAs pending with the FDA, representing approximately $4 billion in 2007 annualized branded sales.

Recent Events

APP has received FDA final approval for Colistimethate for Injection. Shortly after the end of the quarter, the Company received final approvals and launched additional dosages of Granisetron Hydrochloride Injection.

2008 Financial Guidance

 

   

Total net revenues are expected to be in the range of $800 to $820 million;

 

   

Gross margin is anticipated to be approximately 51 to 52 percent relative to total net revenues. This excludes $16.4 million in acquired product portfolio amortization and $2.1 million stock compensation;

 

   

R&D expense is expected to be approximately $25 to $30 million, excluding approximately $25 million associated with technology transfer and capacity optimization of the Puerto Rico manufacturing facility;

 

   

SG&A expenses are anticipated to be in the range of $75 to $80 million, which excludes expected non-cash stock compensation expense of $6 million and approximately $20 million of merger and separation related expenses;

 


APP Pharmaceuticals, Inc

2008 Second Quarter Financial Results

 

   

Interest expense is expected to be approximately $60 million;

 

   

Income tax rate is expected to be approximately 41 percent;

 

   

Depreciation expense is expected to be approximately $20 to $24 million;

 

   

Adjusted EBITDA is expected to be $325 to $350 million. Adjustments, as noted above, reflects the exclusion of costs associated with the technical transfer and operational start-up of the Puerto Rico facility, expenses resulting from the separation of Abraxis Bioscience, costs associated with the ongoing Fresenius merger activities, non-cash compensation costs, and miscellaneous non-recurring costs;

 

   

Adjusted EPS, reported on a consistent basis as Adjusted EBITDA above, is anticipated to be $0.85 to $0.95.

Conference Call Information

On Friday, August 1, 2008, the company will host a conference call with interested parties beginning at 7 a.m. PT (10 a.m. ET) to review the company’s financial results. The conference call will be available to interested parties through a live audio webcast at www.APPpharma.com and www.thomsonone.com. The call will also be archived and accessible at both sites for six months.

Non-GAAP Financial Measures

The company believes that its presentation of non-GAAP financial measures, such as adjusted net income, adjusted income from continuing operations, EBITDA and adjusted EBITDA, provides useful supplementary information to investors in understanding the underlying operating performance of the company and facilitates additional analysis by investors. The company also uses non-GAAP financial measures internally for operating, budgeting and financial planning purposes. The non-GAAP financial measures are in addition to, and not a substitute for or superior to, measures of financial performance calculated in accordance with GAAP. A reconciliation of GAAP net income to adjusted net income for the three and six months ending June 30, 2008 is included with this news release.

About APP Pharmaceuticals

APP is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on oncology, anti-infective and critical care markets. The company is one of the largest producers of injectables, with more than 100 generic products in more than 400 dosage formulations. APP, headquartered in Schaumburg, Illinois, has offices in Canada and manufacturing operations in Illinois, New York and Puerto Rico and is traded on the Nasdaq Global Market under the symbol APPX. For more information about APP and the products it provides, please visit www.APPpharma.com.


APP Pharmaceuticals, Inc

2008 Second Quarter Financial Results

Forward-Looking Statement

The statements contained in this news release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this news release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding financial guidance for 2008, trends in our product lines, and the development and approval of product candidates. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward- looking statements. These factors include, but are not limited to, the continued market acceptance and demand of new and existing products; the difficulties or delays in developing, testing, obtaining regulatory approval of, and producing and marketing of the company’s products; the impact of competitive products and pricing; the availability and pricing of ingredients used in the manufacture of pharmaceutical products; and the ability to successfully manufacture products in a time-sensitive and cost effective manner. Additional relevant information concerning risks can be found in APP Pharmaceuticals Form 10-K for the year ended December 31, 2007 and other documents it has filed with the Securities and Exchange Commission.

The information contained in this news release is as of the date of this release. APP assumes no obligations to update any forward-looking statements contained in this news release as the result of new information or future events or developments.

 

Contacts:

Investors and Media:

Maili Bergman, (310) 405-7522

PondelWilkinson:

Robert J. Jaffe/Rob Whetstone, (310) 279-5969

# # #

FINANCIAL TABLES FOLLOW


APP Pharmaceuticals, Inc.

Consolidated Statements of Operation

(unaudited, in thousands, except per share amounts)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2008     2007     2008     2007  

Net revenues:

        

Critical care

   $ 113,532     $ 89,579     $ 204,714     $ 174,274  

Anti-infective

     59,296       50,749       102,256       90,529  

Oncology

     21,726       14,577       32,747       25,854  

Contract manufacturing

     3,364       4,422       6,280       8,938  
                                

Total net revenues

     197,918       159,327       345,997       299,595  

Cost of sales

     103,771       79,177       181,788       154,008  
                                

Gross profit

     94,147       80,150       164,209       145,587  
                                

Percent to total net revenues

     47.6 %     50.3 %     47.5 %     48.6 %

Operating expenses

        

Research and development

     13,833       12,678       26,163       22,642  

Selling, general and administrative

     21,173       22,678       42,193       44,739  

Amortization of merger related intangibles

     3,857       3,856       7,713       7,712  

Separation costs

     1,212       352       1,603       704  

Merger related costs

     805       —         805       —    
                                

Total operating expenses

     40,880       39,564       78,477       75,797  
                                

Percent to total net revenues

     20.7 %     24.8 %     22.7 %     25.3 %

Income from operations

     53,267       40,586       85,732       69,790  

Percent to total net revenues

     26.9 %     25.5 %     24.8 %     23.3 %

Interest expense and other, net

     (13,527 )     (4,377 )     (29,264 )     (7,987 )
                                

Income from continuing operations before income tax

     39,740       36,209       56,468       61,803  

Income tax expense

     15,848       13,417       23,419       25,394  
                                

Income from continuing operations, net of income tax

     23,892       22,792       33,049       36,409  

Loss from discontinued operations, net of tax

     —         294       —         (2,208 )
                                

Net income

   $ 23,892     $ 23,086     $ 33,049     $ 34,201  
                                

Basic earnings (loss) per share:

        

Continuing operations

   $ 0.15     $ 0.14     $ 0.21     $ 0.23  
                                

Discontinued operations

     —         —         —         (0.02 )
                                

Net income

   $ 0.15     $ 0.14     $ 0.21     $ 0.21  
                                

Diluted earnings (loss) per share:

        

Continuing operations

   $ 0.15     $ 0.14     $ 0.20     $ 0.23  
                                

Discontinued operations

     —         —         —         (0.02 )
                                

Net income

   $ 0.15     $ 0.14     $ 0.20     $ 0.21  
                                

Weighted - average common shares outstanding:

        

Basic

     160,375       159,384       160,443       159,423  
                                

Diluted

     161,155       160,353       161,287       160,481  
                                

Selected ratios as a percentage of total net revenues:

        

Research and development

     7.0 %     8.0 %     7.6 %     7.6 %

Selling, general and administrative

     10.7 %     14.2 %     12.2 %     14.9 %


APP Pharmaceuticals, Inc.

GAAP to Adjusted Earnings from Continuing Operations Reconciliation

(unaudited, in thousands, except per share amounts)

Adjusted income from continuing operations and adjusted income from continuing operations per diluted share are defined as income from continuing operations and diluted earnings from continuing operations per share, respectively, in each case excluding the impact of, non-cash stock compensation expense, separation related costs, amortization of acquired intangible assets and merger related intangibles and Puerto Rico pre-launch costs. We believe that our presentation of non-GAAP financial measures provides useful supplementary information to investors in understanding our underlying operating performance and facilitates additional analysis by investors. We also use non-GAAP financial measures internally for operating, budgeting and financial planning purposes. The non-GAAP financial measures are in addition to, and not a substitute for or superior to, measures of financial performance calculated in accordance with GAAP. A reconciliation of GAAP income from continuing operations to adjusted income from continuing operations for the three months and six months ended June 30, 2008 is below:

 

     For the three months ended
June 30
   For the six months ended
June 30
     2008    2007    2008    2007

Income from continuing operations net of income tax

   $ 23,892    $ 22,792    $ 33,049    $ 36,409

Stock compensation expense

     925      2,129      2,787      4,619

Intangible amortization

     2,784      2,616      5,523      5,234

Separation, merger and other non-recurring costs

     1,933      217      2,185      435

Amortization of purchased product rights

     2,538      2,538      5,076      5,076

Puerto Rico pre-launch costs

     6,396      5,982      11,893      10,857
                           

Adjusted income from continuing operations

   $ 38,468    $ 36,275    $ 60,513    $ 62,630
                           

Adjusted income from continuing operations per diluted share

   $ 0.24    $ 0.23    $ 0.38    $ 0.39
                           

Weighted - average common shares outstanding diluted

     161,155      160,354      161,287      160,481
                           

Income from continuing operations per diluted share

   $ 0.15    $ 0.14    $ 0.21    $ 0.23

Stock compensation expense

     0.01      0.01      0.02      0.03

Intangible amortization

     0.02      0.02      0.03      0.03

Separation, merger and other non-recurring costs

     0.01      0.00      0.01      0.00

Amortization of purchased product rights

     0.01      0.02      0.03      0.03

Puerto Rico pre-launch costs

     0.04      0.04      0.08      0.07
                           

Adjusted income from continuing operations per diluted share

   $ 0.24    $ 0.23    $ 0.38    $ 0.39
                           


APP Pharmaceuticals, Inc.

Reconciliation of Income from Continuing Operations to Adjusted EBITDA

Three and Six Months Ended June 30, 2008

(unaudited, in thousands)

We define adjusted EBITDA from continuing operations as income from continuing operations, excluding the impact of depreciation and amortization, interest expense net of interest income and other income, income tax expense, non-cash stock-based compensation expense, separation related costs and pre-launch costs associated with Puerto Rico manufacturing facility. We use adjusted EBITDA from continuing operations to provide meaningful supplemental information to investors in understanding the underlying operating performance of the business and facilitate additional analysis by investors. We believe that adjusted EBITDA from continuing operations can assist management and investors in assessing the financial operating performance and underlying strength of our core business. Adjusted EBITDA from continuing operations is not a recognized term under GAAP and should not be considered in isolation of, or as a substitute for, the information prepared and presented in accordance with GAAP. Because not all companies calculate adjusted EBITDA from continuing operations identically, our definition of adjusted EBITDA from continuing operations may not be comparable to similarly titled measures of other companies.

 

     For the three months ended June 30    For the six months ended June 30
     2008    2007    2008    2007

Income from continuing operations net of income tax

   $ 23,892    $ 22,792    $ 33,049    $ 36,409

Depreciation

     4,766      4,385      9,258      8,060

Amortization

     8,009      8,347      16,004      16,696

Interest expense, net of interest income

     13,633      4,376      29,878      7,986

Provision for income taxes from continuing operations

     15,848      13,417      23,419      25,394
                           

EBITDA from continuing operations

     66,148      53,317      111,608      94,545

Stock-based compensation expense

     1,498      3,448      4,513      7,480

Puerto Rico pre-launch costs, net of depreciation

     6,409      6,104      11,356      11,079

Separation, merger and other non-recurring costs

     3,130      352      3,539      704
                           

Adjusted EBITDA from continuing operations

   $ 77,185    $ 63,221    $ 131,016    $ 113,808
                           


APP Pharmaceuticals, Inc.

Consolidated Condensed Balance Sheets

(In thousands)

 

     June 30,
2008
    December 31,
2007
 
     (Unaudited)     (Audited)  

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 73,890     $ 31,788  

Accounts receivable, net of allowances

     73,387       85,209  

Inventories

     169,680       149,191  

Prepaid expenses and other current assets

     13,792       13,531  

Current receivables from related parties

     —         6,996  

Income tax receivable

     1,471       —    

Deferred income taxes

     16,020       17,109  
                

Total current assets

     348,240       303,824  

Property, plant and equipment, net

     131,476       132,528  

Intangible assets, net of accumulated amortization

     447,949       463,154  

Goodwill

     160,239       160,239  

Deferred financing costs and other non-current assets, net

     17,159       17,842  
                

Total assets

   $ 1,105,063     $ 1,077,587  
                

Liabilities and stockholders’ deficit

    

Current liabilities:

    

Accounts payable

   $ 38,285     $ 36,502  

Accrued liabilities

     35,952       45,595  

Current payable from related parties

     1,024       —    

Fair value of interest rate swap

     2,084       —    

Short term portion of long term debt

     11,250       5,000  
                

Total current liabilities

     88,595       87,097  
                

Long-term debt

     986,250       995,000  

Deferred income taxes, non-current

     67,064       71,011  

Other non-current liabilities

     4,841       4,250  
                

Total liabilities

     1,146,750       1,157,358  

Total stockholders’ deficit

     (41,687 )     (79,771 )
                

Total liabilities and stockholders’ deficit

   $ 1,105,063     $ 1,077,587