EX-99.1 2 dex991.htm PRESS RELEASE Press Release

EXHIBIT 99.1

 

LOGO   

11755 Wilshire Blvd., 20th Floor

Los Angeles, CA 90025

News Release

 

 

ABRAXIS BIOSCIENCE REPORTS 2009 THIRD QUARTER

FINANCIAL RESULTS

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 lll 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 lll Clinical Trials in Non-Small Cell Lung Cancer, Pancreatic Cancer and Melanoma Continue to Move Forward

LOS ANGELES, Calif. November 5, 2009 — 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

 

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Abraxis BioScience, Inc.

2009 Third Quarter Financial Results

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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.

 

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Abraxis BioScience, Inc.

2009 Third Quarter Financial Results

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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

 

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Abraxis BioScience, Inc.

2009 Third Quarter Financial Results

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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.

 

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Abraxis BioScience, Inc.

2009 Third Quarter Financial Results

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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 lll 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

 

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Abraxis BioScience, Inc.

2009 Third Quarter Financial Results

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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

 

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Abraxis BioScience, Inc.

2009 Third Quarter Financial Results

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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.

Contacts:

 

Investors and Media Inquiries:   
Maili Bergman    Rob Whetstone
Director Investor Relations & Corporate Communications    PondelWilkinson Inc.
310.883.1300    310.279.5963
investorrelations@abraxisbio.com   

 

Financial Tables Follow

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Abraxis BioScience, Inc.

Condensed Consolidated Statements of Operations

(Unaudited, in thousands, except per share amounts)

 

     Three Months Ended
September 30,
    Nine Months Ended
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
September 30,
    Nine Months Ended
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,
2009
    December 31,
2008
 
     (Unaudited)        

Assets

    

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