Abraxis BioScience Reports 2009 Third Quarter Financial Results

Thu Nov 5, 2009 8:15am EST
 
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Third Quarter Highlights:

* Sales of ABRAXANE® Grows to $83 Million, Representing a 10 Percent Sequential
Quarterly Increase
* The Independent Data Monitoring Committee for the ABRAXANE Non-Small Cell Lung
Cancer Phase III Clinical Trial Has Recommended the Trial Proceed to Completion
Without Changes to the Sample Size
* The FDA Has Granted ABRAXANE Orphan Drug Status for the Treatment of
Pancreatic Cancer and Stage IIb-IV Melanoma
* Pivotal Phase III Clinical Trials in Non-Small Cell Lung Cancer, Pancreatic
Cancer and Melanoma Continue to Move Forward

LOS ANGELES--(Business Wire)--
Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology
company, today reported unaudited financial results for the third quarter ending
September 30, 2009. 

As of January 2, 2009, the company re-acquired the exclusive rights to market
ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for
injectable suspension) (albumin-bound) in the U.S. As a result, beginning in
2009, the company no longer recognizes deferred revenue related to the original
co-promotion agreement. 

Net revenue for the third quarter of 2009 was $96.6 million compared with $93.4
million for the third quarter of 2008. ABRAXANE revenue for the third quarter of
2009 was $82.9 million compared with $92.0 million for the same period in 2008,
which included recognition of deferred revenue of $9.1 million related to the
co-promotion agreement. Excluding the recognition of deferred revenue, total
revenue from sales of ABRAXANE remained steady at $82.9 million for both the
third quarter of 2009 and 2008. Other revenue for the third quarter of 2009
increased to $13.8 million from $1.3 million in the comparable period last year,
primarily due to increased sales of raw material. 

Gross profit for the third quarter of 2009 was $76.9 million, or 80 percent of
net revenue, compared with $82.3 million, or 88 percent of net revenue, for the
third quarter of 2008. Excluding the recognition of deferred revenue, gross
margin for the third quarter of 2009 was 80 percent versus 87 percent for the
same period in 2008. The decrease in gross margin was primarily due to an
increase in the sales volume of lower margin products, a voluntarily initiated
recall of certain lots of ABRAXANE and increased sales of ABRAXANE outside of
the United States. 

"We have ambitious plans for ABRAXANE and the nab® technology franchise and
continue to optimize our global and U.S. commercial resources to support growth
in our current markets as well as those we are targeting for 2010," said Lonnie
Moulder, President and Chief Executive Officer of Abraxis BioScience.
"Additionally, we are advancing three pivotal Phase III studies for ABRAXANE, in
non-small cell lung cancer, pancreatic cancer and melanoma, which could enable
us to broaden the utility of this important oncology product. We have an
exciting future before us as we continue to bring this important therapy to
cancer patients worldwide." 

Research and development expense for the third quarter of 2009 was $51.0 million
compared with $21.0 million for the same period in 2008. The majority of the
increase was due to additional spending on Phase III clinical trials for
non-small cell lung cancer, pancreatic cancer and melanoma. The remainder of the
increase was primarily attributable to investments in early stage discovery and
other research and development projects. 

Selling, general and administrative (SG&A) expenses for the third quarter of
2009 were $58.0 million versus $56.3 million for the same period in 2008. The
re-acquisition of ABRAXANE marketing rights in the U.S. yielded savings due to
the elimination of commission payments. These savings were primarily offset by
increased investment in the global expansion of ABRAXANE primarily in China and
the European Union, and increased spending on U.S. sales and marketing. 

On a GAAP basis, net loss for common shareholders for the third quarter of 2009
was $37.7 million, or $0.94 per share, compared with net loss for common
shareholders of $15.1 million, or $0.38 per share, for the third quarter of
2008. 

Adjusted net loss for common shareholders for the third quarter of 2009 was
$24.2 million, or $0.60 per share, compared to adjusted net income for common
shareholders of $10.5 million, or $0.26 per share, for the third quarter of the
prior year. Adjusted net (loss) income for common shareholders excludes
amortization of acquired intangible assets, litigation costs, acquired
in-process research and development, impairment charge, realized loss on
marketable securities and non-cash stock-based compensation expense. 

(Reconciliation tables are provided below) 

Financial Results: Nine Months Ended September 30, 2009

Net revenue for the first nine months of 2009 was $254.3 million compared with
$253.1 million for the same period of 2008. ABRAXANE revenue for the first nine
months of 2009 was $228.6 million compared with $245.8 million for the same
period in 2008, which included recognition of deferred revenue of $27.3 million
related to the co-promotion agreement. Excluding the recognition of deferred
revenue, total revenue from the sales of ABRAXANE for the first nine months of
2009 grew $10.1 million, or 5 percent, to $228.6 million compared with $218.5
million for the same period in 2008. Incremental revenue from the continued
global expansion into China, Australia, and European markets, as well as a
higher average net selling price in the United States, contributed to the
increase in revenue compared to the prior year. 

Other revenue for the first nine months of 2009 increased to $25.7 million from
$7.3 million in the comparable period last year, primarily due to raw materials
sales beginning in the second quarter of 2009. 

Gross profit for the first nine months of 2009 was $210.9 million, or 83 percent
of net revenue, compared with $223.5 million, or 88 percent of net revenue, for
the comparable period of 2008. Excluding the recognition of deferred revenue,
gross margin for the first nine months of 2009 was 83 percent versus 87 percent
for the same period in 2008. The decrease in gross margin was primarily due to
an increase in the sales volume of lower margin products, a voluntarily
initiated recall of certain lots of ABRAXANE and increased sales of ABRAXANE
outside of the United States. 

Research and development expense for the first nine months of 2009 was $122.8
million compared with $61.3 million for the same period in 2008. An increase in
spending on Phase III clinical trials for non-small cell lung cancer, pancreatic
cancer and melanoma accounted for approximately 50% of the increase in R&D
expense. The remainder of the increase is primarily attributable to investments
in early stage discovery and other research and development projects. 

Selling, general and administrative (SG&A) expenses for the first nine months of
2009 were $150.7 million versus $157.3 million for the same period in 2008. The
reacquisition of ABRAXANE marketing rights in the U.S. yielded savings due to
elimination of commission payments. These savings were primarily offset by
increased investment in the global expansion of ABRAXANE primarily in China and
the European Union, and increased spending on U.S. sales and marketing. 

On a GAAP basis, net loss for common shareholders for the first nine months of
2009 was $84.1 million, or $2.10 per share, compared with net loss for common
shareholders of $94.9 million, or $2.37 per share, for the first nine months of
2008. Adjusted net loss for common shareholders for the first nine months of
2009 was $39.9 million, or $1.00 per share, compared to adjusted net income for
common shareholders of $28.7 million, or $0.71 per share, for the first nine
months of the prior year. 

Recent Company Highlights

* According to IntrinsiQ data for September 2009, in all lines of metastatic
breast cancer (MBC), ABRAXANE use has increased for two consecutive quarters
from 34.8 percent to 36.7 percent of the taxane market. On a rolling 12-month
basis, the ABRAXANE share of the total MBC taxane market was 31.7 percent. In
second line + MBC, ABRAXANE has increased for two consecutive quarters from 42.6
percent to 46.2 percent. ABRAXANE continues to be a leader in the taxane market
in the third line + setting of the MBC market with a 51 percent market share. 
* The company has targeted the previously announced spin-off of Abraxis Health
to occur during the first quarter of 2010. 
* The Independent Data Monitoring Committee for the Phase III clinical trial
with ABRAXANE in NSCLC, recently notified the company that it recommends the
trial proceed to completion as per the current protocol without changes to the
sample size. 
* Abraxis BioScience was recently notified that the FDA`s Office of Orphan
Products Development (OOPD) has granted ABRAXANE with orphan drug status in the
treatment of pancreatic cancer and melanoma stage IIb-IV.

Conference Call Information

On Thursday, November 5, 2009, the company will host a conference call with
interested parties beginning at 8:30 a.m. PST/11:30 a.m. EST to review its
results of operations for the third quarter of 2009. The conference call may be
heard by interested parties through a live audio Internet broadcast at
www.abraxisbio.com and www.earnings.com. For those unable to listen to the live
broadcast, a playback of the webcast will be available at both Web sites for
approximately six months beginning shortly after the conclusion of the call. 

Non-GAAP Financial Measures

The company believes that its presentation of non-GAAP financial measures, such
as adjusted net (loss) income for common shareholders and adjusted net (loss)
income per common share, provide 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 presented by the company may not be
comparable to similarly titled measures reported by other companies. 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 loss to adjusted net (loss) income for common
shareholders for the three and nine months ended September 30, 2009 and 2008 is
included with this news release. 

About ABRAXANE®

ABRAXANE® is a solvent-free chemotherapy treatment option for metastatic breast
cancer which was developed using Abraxis BioScience's proprietary nab®
technology platform. This protein-bound chemotherapy agent combines paclitaxel
with albumin, a naturally-occurring human protein. By wrapping the albumin
around the active drug, ABRAXANE can be administered to patients at higher
doses, delivering higher concentrations of paclitaxel to the tumor site than
solvent-based paclitaxel. ABRAXANE is currently in various stages of
investigation for the treatment of the following cancers: expanded applications
for metastatic breast, non-small cell lung, malignant melanoma and pancreatic. 

The U.S. Food and Drug Administration approved ABRAXANE for Injectable
Suspension (paclitaxel protein-bound particles for injectable suspension)
(albumin-bound) in January 2005 for the treatment of breast cancer after failure
of combination chemotherapy for metastatic disease or relapse within six months
of adjuvant chemotherapy. Prior therapy should have included an anthracycline
unless clinically contraindicated. For the full prescribing information for
ABRAXANE please visit www.abraxane.com. 

About Abraxis BioScience, Inc.

Abraxis BioScience is a fully integrated global biotechnology company dedicated
to the discovery, development and delivery of next-generation therapeutics and
core technologies that offer patients safer and more effective treatments for
cancer and other critical illnesses. The company's portfolio includes the
world's first and only protein-bound nanoparticle chemotherapeutic compound
(ABRAXANE®), which is based on the company's proprietary tumor targeting
technology known as the nab® platform. The first FDA approved product to use
this nab platform, ABRAXANE, was launched in 2005 for the treatment of
metastatic breast cancer and is now approved in 38 countries. The company
continues to expand the nab platform through a robust clinical program and deep
product pipeline. Abraxis trades on the NASDAQ Global Market under the symbol
ABII. For more information about the company and its products, please visit
www.abraxisbio.com. 

FORWARD-LOOKING STATEMENTS

The statements contained in this press 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
press release include statements regarding our expectations, beliefs, hopes,
goals, intentions, initiatives or strategies, including statements regarding the
clinical development plan, and the timing and scope of clinical studies and
trials, for ABRAXANE and the global commercialization of ABRAXANE. 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, without limitation, the fact
that results from pre-clinical studies may not be predictive of results to be
obtained in other pre-clinical studies or future clinical trials; delays in
commencement and completion of clinical studies or trials, including slower than
anticipated patient enrollment and adverse events occurring during the clinical
trials; decisions by regulatory authorities regarding whether and when to
approve ABRAXANE or product candidates for various indications as well as their
decisions regarding labeling and other matters that could affect the
availability or commercial potential of ABRAXANE and other products and product
candidates; unexpected safety, efficacy or manufacturing issues with respect to
ABRAXANE or product candidates; the need for additional data or clinical studies
for ABRAXANE or product candidates; regulatory developments (domestic or
foreign) involving the company`s manufacturing facilities; the market adoption
and demand of ABRAXANE and other products, the costs associated with the ongoing
launch of ABRAXANE; research and development associated with the nab® technology
platform; the impact of pharmaceutical industry regulation; the impact of
competitive products and pricing; the availability and pricing of ingredients
used in the manufacture of pharmaceutical products; the ability to successfully
manufacture products in a time-sensitive and cost effective manner; the
acceptance and demand of new pharmaceutical products; and the impact of patents
and other proprietary rights held by competitors and other third parties.
Additional relevant information concerning risks can be found in the company`s
Annual Report on Form 10-K for the year ended December 31, 2008 and in other
documents it has filed with the Securities and Exchange Commission. 

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

 Abraxis BioScience, Inc.                                                                                                                                                                      
 Condensed Consolidated Statements of Operations                                                                                                                                               
 (Unaudited, in thousands, except per share amounts)                                                                                                                                           
                                                                                                                                                                                     
                                                                                Three Months Ended                                      Nine Months Ended                                 
                                                                                September 30,                                           September 30,                                     
                                                                                2009                      2008                       2009                      2008                  
 Abraxane revenue                                                               $    82,854             $    92,045              $    228,627            $    245,810        
 Other revenue                                                                       13,774                  1,336                    25,712                  7,335          
 Net revenue                                                                         96,628                  93,381                   254,339                 253,145        
 Cost of sales                                                                       19,714                  11,128                   43,457                  29,680         
 Gross profit                                                                        76,914                  82,253                   210,882                 223,465        
                                                                                                                                                                                     
 Operating expenses                                                                                                                                                                  
 Research and development                                                            51,030                  21,015                   122,772                 61,325         
 Selling, general and administrative                                                 58,013                  56,273                   150,708                 157,313        
 Litigation costs                                                                    -                       221                      -                       57,609         
 Acquired in-process research and development                                        -                       -                        -                       13,900         
 Impairment charge                                                                   -                       9,214                    -                       9,214          
 Amortization of intangible assets                                                   9,952                   9,872                    29,859                  29,483         
 Equity in net income loss of Drug Source Co, LLC                                    (1,090   )              (469     )               (2,450   )              (245      )    
 Total operating expenses                                                            117,905                 96,126                   300,889                 328,599        
                                                                                                                                                                                     
 Loss from operations                                                                (40,991  )              (13,873  )               (90,007  )              (105,134  )    
 Interest income                                                                     614                     4,274                    2,501                   15,385         
 Other income (expenses)                                                             743                     (5,481   )               240                     (4,941    )    
 Loss before income taxes                                                            (39,634  )              (15,080  )               (87,266  )              (94,690   )    
 (Benefit) provision for income taxes                                                (1,590   )              (21      )               (1,641   )              203            
 Net loss                                                                       $    (38,044  )         $    (15,059  )          $    (85,625  )         $    (94,893   )    
 Net loss for non-controlling interests                                              (330     )              -                        (1,557   )              -              
 Net loss for common shareholders                                               $    (37,714  )         $    (15,059  )          $    (84,068  )         $    (94,893   )    
                                                                                                                                                                                     
 Basic and diluted net loss per common share                                    $    (0.94    )         $    (0.38    )          $    (2.10    )         $    (2.37     )    
 Basic and diluted weighted average common shares outstanding                        40,100                  40,048                   40,098                  40,021         
                                                                                                                                                                                     
 The composition of stock-based compensation included above is as follows:                                                                                                           
 Cost of sales                                                                  $    61                 $    108                 $    251                $    273            
 Research and development                                                            1,333                   555                      3,618                   2,954          
 Selling, general and administrative                                                 2,148                   1,342                    7,451                   5,881          
 Total stock-based compensation                                                 $    3,542              $    2,005               $    11,320             $    9,108          
                                                                                                                                                                                     
 Selected ratios as a percentage of net revenue:                                                                                                                                     
 Gross profit                                                                        79.6     %              88.1     %               82.9     %              88.3      %    
 Research and development                                                            52.8     %              22.5     %               48.3     %              24.2      %    
 Selling, general and administrative                                                 60.0     %              60.3     %               59.3     %              62.1      %    
                                                                                                                                                                             
                                                                                                                                                                             


 Abraxis BioScience, Inc.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
 GAAP Net Loss to Adjusted Net Income (Loss) for Common Shareholders and Per Share Reconciliation                                                                                                                                                                                                                                                                                                                                                                                                                                
 (Unaudited, in thousands, except per share amounts)                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
 Adjusted net income (loss) for common shareholders and adjusted net income (loss) per common share are defined as net loss for common shareholders and net loss per common share, respectively, in each case excluding amortization of intangible assets, litigation costs, acquired in-process research and development, impairment charge, realized loss on marketable securities and non-cash stock compensation expense.   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 below may not be comparable to similarly titled measures reported by other companies.  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.  Reconciliation of net loss and net loss per common share to adjusted net income (loss) for common shareholders and adjusted net income (loss) per common share for each of the three and nine months ended September 30, 2009 and 2008 is below:                                                                                                                                                                                                                                                                    


                                                             Three Months Ended                                         Nine Months Ended                                      
                                                             September 30,                                              September 30,                                          
                                                             2009                           2008                     2009                           2008                 
 Net loss for common shareholders                            $    (37,714  )              $    (15,059  )        $    (84,068  )              $    (94,893  )    
 Amortization of intangible assets                                9,952                        9,872                  29,859                       29,483        
 Litigation costs (a)                                             -                            221                    -                            57,609        
 Acquired in-process research and development (b)                 -                            -                      -                            13,900        
 Impairment charge (c)                                            -                            9,214                  -                            9,214         
 Realized loss on marketable securities (d)                       -                            4,247                  2,944                        4,247         
 Stock compensation expense                                       3,542                        2,005                  11,320                       9,108         
 Adjusted net (loss) income for common shareholders          $    (24,220  )              $    10,500            $    (39,945  )              $    28,668        
                                                                                                                                                                         
 Adjusted net (loss) income per common share                 $    (0.60    )              $    0.26              $    (1.00    )              $    0.71          
 Weighted average common diluted shares outstanding (e)           40,100                       40,309                 40,098                       40,247        
                                                                                                                                                                         
 Net loss per common share                                   $    (0.94    )              $    (0.38    )        $    (2.10    )              $    (2.37    )    
 Amortization of intangible assets                                0.25                         0.25                   0.75                         0.74          
 Litigation costs (a)                                             -                            0.01                   -                            1.44          
 Acquired in-process research and development (b)                 -                            -                      -                            0.34          
 Impairment charge (c)                                            -                            0.23                   -                            0.23          
 Realized loss on marketable securities (d)                       -                            0.10                   0.07                         0.10          
 Stock compensation expense                                       0.09                         0.05                   0.28                         0.23          
 Adjusted net (loss) income per common share                 $    (0.60    )              $    0.26              $    (1.00    )              $    0.71          
                                                                                                                                                                 


 (a) In 2008, we accrued $57.6 million for a litigation matter, which we will appeal.                                                                                                                                                                                                        
 (b) Represents in-process research and development projects expensed in connection with the acquisition of Shimoda Biotech and Platco Technologies in April 2008.                                                                                                                           
 (c) As a result of an anticipated sale of property, plant and equipment, we recorded an asset impairment charge totaling $9.2 million during the three months ended September 30, 2008. In March 2009, we sold the shares of our subsidiary, which held the property, plant and equipment.  
 (d) Represents write-down of marketable securities whose decline in values were determined to be other than temporary.                                                                                                                                                                      
 (e) Because there is adjusted net income for common shareholders in 2008, the calculation of weighted average common diluted shares includes potentially dilutive common shares of 261,000 and 226,000 for the three and nine months ended September 30, 2008, respectively.                
                                                                                                                                                                                                                                                                                             
                                                                                                                                                                                                                                                                                             


 Abraxis BioScience, Inc.                                                                                                
 Condensed Consolidated Balance Sheets                                                                                   
 (In thousands)                                                                                                          
                                                                                                                         
                                                         September 30,                  December 31,               
                                                         2009                           2008                       
 Assets                                                  (Unaudited)                                               
 Current assets:                                                                                                   
 Cash and cash equivalents                               $      188,287               $      306,390           
 Cash collateral for reacquisition agreement                    -                            300,631           
 Accounts receivable, net of chargebacks                        47,930                       37,011            
 Related party receivable                                       2,184                        1,915             
 Inventories                                                    50,951                       63,506            
 Prepaid expenses and other current assets                      48,179                       33,795            
 Deferred income taxes                                          64,882                       65,585            
 Total current assets                                           402,413                      808,833           
 Property, plant and equipment, net                             239,585                      166,720           
 Investment in Drug Source Company, LLC                         12,633                       10,183            
 Intangible assets, net of accumulated amortization             155,111                      175,291           
 Goodwill                                                       241,361                      241,361           
 Other non-current assets                                       51,349                       36,196            
 Total assets                                            $      1,102,452             $      1,438,584         
                                                                                                                   
 Liabilities and stockholders' equity                                                                              
 Current liabilities:                                                                                              
 Accounts payable                                        $      20,864                $      39,142            
 Accrued liabilities                                            79,998                       53,020            
 Accrued litigation costs                                       57,711                       57,635            
 Reacquisition payable                                          -                            268,000           
 Income taxes payable                                           567                          679               
 Deferred revenue                                               3,141                        4,209             
 Total current liabilities                                      162,281                      422,685           
                                                                                                                   
 Deferred income taxes, non-current                             66,686                       62,685            
 Long-term portion of deferred revenue                          5,652                        8,223             
 Other non-current liabilities                                  8,821                        15,519            
 Total liabilities                                              243,440                      509,112           
                                                                                                                   
 Equity:                                                                                                           
 Stockholders' equity                                                                                              
 Common stock                                                   40                           40                
 Additional paid-in capital                                     1,209,680                    1,203,092         
 Accumulated deficit                                            (356,757   )                 (272,689   )      
 Accumulated other comprehensive income (loss)                  2,451                        (971       )      
 Total stockholders' equity                                     855,414                      929,472           
 Non-controlling interest                                       3,598                        -                 
 Total equity                                                   859,012                      929,472           
 Total liabilities and equity                            $      1,102,452             $      1,438,584         


Investors and Media Inquiries:
Abraxis BioScience, Inc.
Maili Bergman
Director Investor Relations & Corporate Communications
310-883-1300
investorrelations@abraxisbio.com
or
PondelWilkinson Inc.
Rob Whetstone
310-279-5963 

Copyright Business Wire 2009

 

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