ABII » Topics » Overview

These excerpts taken from the ABII 10-K filed Mar 12, 2010.

Overview

We are a Delaware corporation that was formed in June 2007. Our business was conducted as part of Old Abraxis prior to the separation. References in this Annual Report on Form 10-K to the historical assets, liabilities, products, businesses or activities of our company are generally intended to refer to the historical assets, liabilities, products, businesses or activities of the business as it was conducted as part of Old Abraxis prior to the separation.

We are one of the few fully integrated biotechnology companies, with a breakthrough marketed product (Abraxane®), global ownership of our proprietary technology platform and clinical pipeline, and dedicated nanoparticle manufacturing capabilities for worldwide supply integrated with seasoned in-house capabilities, including discovery, clinical drug development, regulatory and sales and marketing.

We are 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. Our portfolio includes the world’s first and only protein-based nanoparticle chemotherapeutic compound (Abraxane®), which is based on our proprietary tumor targeting technology known as the nab® technology platform. This nab® technology platform is the first to exploit the tumor’s biology against itself, taking advantage of an albumin-specific, receptor-mediated transport system and allowing the delivery of a drug from the vascular space across the blood vessel wall to the underlying tumor tissue. Abraxane® is the first clinical and commercial validation of our nab® technology platform. From the discovery and research phase to development and commercialization, we are committed to rapidly enhancing our product pipeline and accelerating the delivery of breakthrough therapies that will transform the lives of patients who need them.

We own the worldwide rights to Abraxane®, a next-generation, nanometer-sized, solvent-free taxane that was approved by the U.S. Food and Drug Administration, or the FDA, in January 2005 for its initial indication in

 

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the treatment of metastatic breast cancer and launched in February 2005. We believe the successful launch of Abraxane® validates our nab® tumor targeting technology, a novel biologically interactive (receptor-mediated) system to deliver chemotherapeutic agents. Abraxane® revenue for the year ended December 31, 2009, 2008 and 2007 was $314.5 million, $335.6 million and $324.7 million, respectively, which in 2008 and 2007 included the recognition of deferred revenue related to our co-promotion agreement with AstraZeneca UK Limited. In January 2009, we re-acquired from AstraZeneca the exclusive rights to market Abraxane® in the United States, thereby ending the co-promotion agreement.

Our research and development approach is based on the integration of our nab® tumor targeting technology, our natural product drug discovery platform, our multi-functional chemistry capabilities with our in-house clinical trial and regulatory strengths, combined with our unique nanoparticle manufacturing capabilities. Our product pipeline includes over five clinical oncology and cardiovascular product candidates in various stages of testing and development, including Abraxane® and Coroxane™ for various indications. We also have several discovery product candidates and novel chemical entities for various diseases, including cancer, multiple sclerosis and Alzheimer’s. We believe the application of our nab® technology will serve as the platform for the development of numerous drugs for the treatment of cancer and other critical illnesses. To leverage in-house manufacturing, clinical trial and regulatory expertise, we will continue to supplement our discovery efforts through technology acquisitions and external collaborations with academia and start-up biotechnology companies.

Overview

Abraxane® is a next-generation, nanometer-sized, solvent-free taxane that was approved by the FDA in January 2005 for its initial indication in the treatment of metastatic breast cancer and launched in February 2005. As of December 2009, Abraxane was approved for marketing in 39 countries. Taxanes are one of the most widely used chemotherapy agents. We believe the successful launch of Abraxane® validates our nab® tumor targeting technology described below. Effective January 1, 2006, we received a unique reimbursement “J” code for Abraxane® in the U.S., which facilitates reimbursement from Medicare and Medicaid as well as private payors.

OVERVIEW

The following management’s discussion and analysis of financial condition and results of operations, or MD&A is intended to assist the reader in understanding our company. The MD&A is provided as a supplement to, and should be read in conjunction with the other sections of this Annual Report on Form 10-K, including “Item 1: Business”; “Item 1A: Risk Factors”, “Item 6: Selected Financial Data”; and “Item 8: Financial Statements and Supplemental Data.”

These excerpts taken from the ABII 10-Q filed May 8, 2009.

OVERVIEW

The following management’s discussion and analysis of financial condition and results of operations, or MD&A, is intended to assist the reader in understanding our company. The MD&A is provided as a supplement to, and should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2008, including “Item 1: Business”; “Item 1A: Risk Factors”; “Item 6: Selected Financial Data”; and “Item 8: Financial Statements and Supplementary Data.”

Overview

The following table summarizes key elements of our financial position and sources and (uses) of cash and cash equivalents as follows:

 

     March 31,
2009
    December 31,
2008
 
     (unaudited)        
     (in thousands)  

Summary Financial Position

    

Cash and cash equivalents

   $ 302,798     $ 306,390  

Cash collateral for reacquisition of agreement

     —         300,631  

Working capital

     359,149       386,148  

Total assets

     1,131,000       1,438,584  

Total stockholders’ equity

     908,833       929,472  
     Three Months Ended March 31,  
     2009     2008  
     (unaudited, in thousands)  

Summary of Sources and (Uses) of Cash and Cash Equivalents:

    

Operating activities

   $ 9,367     $ (583 )

Purchases of property, plant and equipment

     (18,963 )     (1,859 )

Purchases of investments and marketable securities

     —         (4,492 )

Proceeds from sale of subsidiary

     2,046       —    

Proceeds from sale of marketable securities

     3,676       —    

Financing activities

     269       28  
These excerpts taken from the ABII 10-K filed Mar 6, 2009.

Overview

We are a Delaware corporation that was formed in June 2007. Our business was conducted as part of Old Abraxis prior to the separation. References in this Annual Report on Form 10-K to the historical assets, liabilities, products, businesses or activities of our company are generally intended to refer to the historical assets, liabilities, products, businesses or activities of the business as it was conducted as part of Old Abraxis prior to the separation.

We are one of the few fully integrated biotechnology companies, with a breakthrough marketed product (Abraxane®), global ownership of our proprietary technology platform and clinical pipeline, dedicated nanoparticle manufacturing capabilities for worldwide supply integrated with seasoned in-house capabilities, including discovery, clinical drug development, regulatory and sales and marketing.

We are 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. Our portfolio includes the world’s first and only protein-based nanoparticle chemotherapeutic compound (Abraxane®) which is based on our proprietary tumor targeting technology known as the nab® technology platform. This nab® technology platform is the first to exploit the tumor’s biology against itself, taking advantage of an albumin-specific, receptor-mediated transport system and allowing the delivery of a drug from the vascular space across the blood vessel wall to the underlying tumor tissue. Abraxane® is the first clinical and commercial validation of our nab® technology platform. From the discovery and research phase to development and commercialization, we are committed to rapidly enhancing our product pipeline and accelerating the delivery of breakthrough therapies that will transform the lives of patients who need them.

We own the worldwide rights to Abraxane®, a next-generation, nanometer-sized, solvent-free taxane that was approved by the U.S. Food and Drug Administration, or the FDA, in January 2005 for its initial indication in the treatment of metastatic breast cancer and launched in February 2005. We believe the successful launch of Abraxane® validates our nab® tumor targeting technology, a novel biologically interactive (receptor-mediated) system to deliver chemotherapeutic agents in high concentrations preferentially to all tumors secreting a protein called SPARC, which attracts and binds to albumin. Abraxane® revenue for the year ended December 31, 2008 and 2007 was $ 335.6 million and $324.7 million, respectively, which included the recognition of previously deferred revenue related to our June 2006 co-promotion agreement with AstraZeneca UK Limited. In January 2009, we re-acquired from AstraZeneca the exclusive rights to market Abraxane® in the United States, thereby ending the co-promotion agreement.

 

5


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Our research and development approach is based on the integration of our nab® tumor targeting technology, our natural product drug discovery platform, our multi-functional chemistry capabilities with our in-house clinical trial and regulatory strengths, combined with our unique nanoparticle manufacturing capabilities. Our product pipeline includes over five clinical oncology and cardiovascular product candidates in various stages of testing and development, including Abraxane® and Coroxane™ for various indications. We also have over 45 discovery product candidates and novel chemical entities for various diseases, including cancer, multiple sclerosis and Alzheimer’s. We believe the application of our nab® technology will serve as the platform for the development of numerous drugs for the treatment of cancer and other critical illnesses. To leverage in-house manufacturing, clinical trial and regulatory expertise, we will continue to supplement our discovery efforts through technology acquisitions and external collaborations with academia and start-up biotechnology companies.

Overview

STYLE="margin-top:6px;margin-bottom:0px; text-indent:4%">We are a Delaware corporation that was formed in June 2007. Our business was conducted as part of Old Abraxis prior to the separation. References in this
Annual Report on Form 10-K to the historical assets, liabilities, products, businesses or activities of our company are generally intended to refer to the historical assets, liabilities, products, businesses or activities of the business as it was
conducted as part of Old Abraxis prior to the separation.

We are one of the few
fully integrated biotechnology companies, with a breakthrough marketed product (Abraxane®), global ownership of our proprietary technology platform and clinical pipeline, dedicated
nanoparticle manufacturing capabilities for worldwide supply integrated with seasoned in-house capabilities, including discovery, clinical drug development, regulatory and sales and marketing.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%;padding-bottom:3px;line-height:95%; vertical-align:top">We are 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. Our portfolio includes the world’s first and only protein-based nanoparticle chemotherapeutic compound (AbraxaneFACE="Times New Roman" SIZE="1">®
) which is based on our proprietary tumor targeting technology known as the nab® technology platform. This nabFACE="Times New Roman" SIZE="1">® technology platform is the first to exploit the tumor’s biology against itself, taking advantage of an albumin-specific, receptor-mediated transport system and allowing the delivery of
a drug from the vascular space across the blood vessel wall to the underlying tumor tissue. Abraxane® is the first clinical and commercial validation of our nabFACE="Times New Roman" SIZE="1">® technology platform. From the discovery and research phase to development and commercialization, we are committed to rapidly enhancing our product pipeline and accelerating the delivery of
breakthrough therapies that will transform the lives of patients who need them.

We
own the worldwide rights to Abraxane®, a next-generation, nanometer-sized, solvent-free taxane that was approved by the U.S. Food and Drug Administration, or the FDA, in January 2005
for its initial indication in the treatment of metastatic breast cancer and launched in February 2005. We believe the successful launch of Abraxane® validates our nabFACE="Times New Roman" SIZE="1">®
tumor targeting technology, a novel biologically interactive (receptor-mediated) system to deliver chemotherapeutic agents in high concentrations preferentially to all tumors secreting a
protein called SPARC, which attracts and binds to albumin. Abraxane® revenue for the year ended December 31, 2008 and 2007 was $ 335.6 million and $324.7 million,
respectively, which included the recognition of previously deferred revenue related to our June 2006 co-promotion agreement with AstraZeneca UK Limited. In January 2009, we re-acquired from AstraZeneca the exclusive rights to market
Abraxane® in the United States, thereby ending the co-promotion agreement.

 


5







Table of Contents


Our research and development approach is based on
the integration of our nab® tumor targeting technology, our natural product drug discovery platform, our multi-functional chemistry capabilities with our in-house clinical trial and
regulatory strengths, combined with our unique nanoparticle manufacturing capabilities. Our product pipeline includes over five clinical oncology and cardiovascular product candidates in various stages of testing and development, including
Abraxane® and Coroxane™ for various indications. We also have over 45 discovery product candidates and novel chemical entities for various diseases, including cancer, multiple
sclerosis and Alzheimer’s. We believe the application of our nab® technology will serve as the platform for the development of numerous drugs for the treatment of cancer and
other critical illnesses. To leverage in-house manufacturing, clinical trial and regulatory expertise, we will continue to supplement our discovery efforts through technology acquisitions and external collaborations with academia and start-up
biotechnology companies.

Overview

Abraxane® is a next-generation, nanometer-sized, solvent-free taxane that was approved by the FDA in January 2005 for its initial indication in the treatment of metastatic breast cancer and launched in February 2005. As of December 2008, Abraxane was approved for marketing in 36 countries. Taxanes are one of the most widely used chemotherapy agents. We believe the successful launch of Abraxane® validates our nab® tumor targeting technology described below. Effective January 1, 2006, we received a unique reimbursement “J” code for Abraxane®, which facilitates reimbursement from Medicare and Medicaid as well as private payors.

Overview

STYLE="margin-top:6px;margin-bottom:0px; text-indent:4%;padding-bottom:3px;line-height:95%; vertical-align:top">Abraxane® is a next-generation,
nanometer-sized, solvent-free taxane that was approved by the FDA in January 2005 for its initial indication in the treatment of metastatic breast cancer and launched in February 2005. As of December 2008, Abraxane was approved for
marketing in 36 countries. Taxanes are one of the most widely used chemotherapy agents. We believe the successful launch of Abraxane® validates our nabSIZE="1">® tumor targeting technology described below. Effective January 1, 2006, we received a unique reimbursement “J” code for Abraxane®, which
facilitates reimbursement from Medicare and Medicaid as well as private payors.

OVERVIEW

The following management’s discussion and analysis of financial condition and results of operations, or MD&A is intended to assist the reader in understanding our company. The MD&A is provided as a supplement to, and should be read in conjunction with the other sections of this Annual Report on Form 10-K, including “Item 1: Business”; “Item 1A: Risk Factors”, “Item 6: Selected Financial Data”; and “Item 8: Financial Statements and Supplemental Data.”

OVERVIEW

SIZE="2">The following management’s discussion and analysis of financial condition and results of operations, or MD&A is intended to assist the reader in understanding our company. The MD&A is provided as a supplement to, and should be
read in conjunction with the other sections of this Annual Report on Form 10-K, including “Item 1: Business”; “Item 1A: Risk Factors”, “Item 6: Selected Financial Data”; and “Item 8: Financial Statements and
Supplemental Data.”

Overview

The following tables summarize key elements of our financial position and sources and (uses) of cash and cash equivalents for the three years ended December 31, 2008:

 

     December 31,  
     2008     2007     2006  
     (in thousands)  

Summary Financial Position

      

Cash and cash equivalents

   $ 306,390     $ 705,125     $ 525  

Cash collateral for reacquisition of agreement

     300,631       —         —    

Working capital

     386,148       735,181       25,093  

Total assets

     1,438,584       1,502,255       764,783  

Total stockholders’ equity

     929,472       1,197,387       459,021  
     Year Ended December 31,  
     2008     2007     2006  
     (in thousands)  

Summary of (Uses) and Sources of Cash and Cash Equivalents:

      

Operating activities

   $ (315,468 )   $ (2,893 )   $ 170,870  

Purchases of property, plant and equipment

     (43,729 )     (40,581 )     (64,431 )

Purchases of investments and marketable securities

     (19,730 )     (150 )     —    

Cash paid for acquisition, net of cash acquired

     (14,998 )     —         —    

Purchases of investments and other assets

     (7,105 )     (4,174 )     (14,800 )

Financing activities

     2,360       752,082       (94,398 )
This excerpt taken from the ABII 10-Q filed Nov 14, 2008.

Overview

The following table summarizes key elements of our financial position and sources and (uses) of cash and cash equivalents as follows:

 

     September 30,
2008
    December 31,
2007
 
     (unaudited)        
     (in thousands)  

Summary Financial Position

    

Cash, cash equivalents and short-term investments

   $ 643,747     $ 705,125  

Working capital

     658,455       735,181  

Total assets

     1,453,093       1,502,255  

Total stockholders’ equity

     1,107,666       1,197,387  
     Nine Months Ended September 30,  
     2008     2007  
     (unaudited, in thousands)  

Summary of Sources and (Uses) of Cash and Cash Equivalents:

    

Operating activities

   $ (9,513 )   $ (7,428 )

Purchases of property, plant and equipment

     (22,620 )     (35,537 )

Cash paid for acquisition, net of cash acquired

     (14,998 )     —    

Purchases of investments and other marketable securities

     (16,393 )     (1,750 )

Financing activities

     2,128       44,844  
This excerpt taken from the ABII 10-Q filed Aug 14, 2008.

Overview

The following table summarizes key elements of our financial position and sources and (uses) of cash and cash equivalents as follows:

 

     June 30,
2008
    December 31,
2007
 
     (unaudited)        
     (in thousands)  

Summary Financial Position

    

Cash, cash equivalents and short-term investments

   $ 656,969     $ 705,125  

Working capital

     660,976       735,181  

Total assets

     1,462,488       1,502,255  

Total stockholders’ equity

     1,119,800       1,197,387  
     Six Months Ended June 30,  
     2008     2007  
     (unaudited, in thousands)  

Summary of Sources and (Uses) of Cash and Cash Equivalents:

    

Operating activities

   $ (11,193 )   $ (18,963 )

Purchases of property, plant and equipment

     (13,248 )     (16,382 )

Cash paid for acquisition, net of cash acquired

     (14,998 )     —    

Purchases of investments and other marketable securities

     (9,393 )     (1,783 )

Financing activities

     639       37,097  
This excerpt taken from the ABII 10-Q filed May 15, 2008.

Overview

The following table summarizes key elements of our financial position and sources and (uses) of cash and cash equivalents as follows:

 

     March 31,
2008
    December 31,
2007
 
     (unaudited, in thousands)  

Summary Financial Position

    

Cash, cash equivalents and short-term investments

   $ 698,244     $ 705,125  

Working capital

     739,428       735,181  

Total assets

     1,483,505       1,502,255  

Total stockholders’ equity

     1,203,493       1,197,387  
     Three Months Ended March 31,  
     2008     2007  
     (unaudited, in thousands)  

Summary of Sources and (Uses) of Cash and Cash Equivalents:

    

Operating activities

   $ (583 )   $ (32,672 )

Purchases of property, plant and equipment

     (1,859 )     (11,268 )

Purchases of investments and other marketable securities

     (4,492 )     (539 )

Financing activities

     28       44,601  
These excerpts taken from the ABII 10-K filed Mar 31, 2008.

Overview

The following table summarizes key elements of our financial position and sources and (uses) of cash and cash equivalents for the three years ended December 31, 2007:

 

     Year Ended December 31,  
   2007     2006     2005  
     (in thousands)  

Summary Financial Position

      

Cash, cash equivalents and short-term investments

   $ 705,125     $ 525     $ 2,291  

Working capital

     735,181       25,093       55,232  

Total assets

     1,502,255       764,783       179,080  

Long-term debt and notes payable

     —         —         190,000  

Total stockholders’ equity (deficit)

     1,197,387       459,021       (65,644 )

Summary of Sources and (Uses) of Cash and Cash Equivalents:

      

Operating activities

   $ (2,893 )   $ 170,870     $ (22,272 )

Purchases of property, plant and equipment

     (40,581 )     (64,431 )     (17,212 )

Purchases of other non-current assets

     (4,324 )     (14,800 )     (1,163 )

Financing activities

     752,082       (94,398 )     40,728  

Overview

FACE="Times New Roman" SIZE="2">The following table summarizes key elements of our financial position and sources and (uses) of cash and cash equivalents for the three years ended December 31, 2007:

STYLE="font-size:12px;margin-top:0px;margin-bottom:0px"> 
































































































































































































   Year Ended December 31, 
  2007  2006  2005 
   (in thousands) 

Summary Financial Position

    

Cash, cash equivalents and short-term investments

  $705,125  $525  $2,291 

Working capital

   735,181   25,093   55,232 

Total assets

   1,502,255   764,783   179,080 

Long-term debt and notes payable

   —     —     190,000 

Total stockholders’ equity (deficit)

   1,197,387   459,021   (65,644)

Summary of Sources and (Uses) of Cash and Cash Equivalents:

    

Operating activities

  $(2,893) $170,870  $(22,272)

Purchases of property, plant and equipment

   (40,581)  (64,431)  (17,212)

Purchases of other non-current assets

   (4,324)  (14,800)  (1,163)

Financing activities

   752,082   (94,398)  40,728 
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