ABII » Topics » Second Quarter Highlights:

This excerpt taken from the ABII 8-K filed Nov 5, 2009.

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)

This excerpt taken from the ABII 8-K filed Aug 6, 2009.

Second Quarter Highlights:

 

   

ABRAXANE® Revenue Grows to $75 Million, Representing a 6 Percent Sequential Quarterly Increase

 

   

Company Reports Net Loss for Common Shareholders of $23 Million, or $0.58 Per Share, or Adjusted Net Loss for Common Shareholders of $10 Million, or $0.25 Per Share

LOS ANGELES, Calif. August 6, 2009 — Abraxis BioScience, Inc. (NASDAQ: ABII), a fully integrated biotechnology company, today reported unaudited financial results for the second quarter ended June 30, 2009.

As of January 2, 2009, the company re-acquired the exclusive rights to market ABRAXANE® (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 second quarter of 2009 was $85.1 million compared with $77.6 million for the second quarter of 2008. Revenue from sales of ABRAXANE for the second quarter of 2009 was $75.2 million compared with $73.8 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 for the second quarter of 2009 grew 16 percent to $75.2 million compared with $64.7 million for the same period in 2008. Other revenue for the second quarter of 2009 increased to $10.0 million from $3.8 million in the comparable period last year, primarily due to increased raw material sales.


Abraxis BioScience, Inc.

2009 Second Quarter Financial Results

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Gross profit for the second quarter of 2009 was $70.5 million, or 83 percent of net revenue, compared with $67.7 million, or 87 percent of net revenue, for the second quarter of 2008. Excluding the recognition of deferred revenue, gross margin for the second quarter of 2009 was 83 percent versus 85 percent for the same period in 2008.

“We continued to make solid progress this quarter advancing the global commercialization of ABRAXANE in the U.S. with our newly expanded sales force, in Europe with ongoing roll-outs in the U.K. and Germany, and in China with the recent product launch in that country,” said Lonnie Moulder, President and Chief Executive Officer of Abraxis BioScience. “We also expanded the body of clinical data for ABRAXANE and other compounds that utilize our proprietary nab® technology platform in new oncology settings, initiating Phase III studies in pancreatic cancer and melanoma and continuing to move forward with our Phase III study in non-small cell lung cancer. Additionally, we have an experienced and talented team of executives who intend to continue this momentum for the balance of the year as we advance our vision of serving patients globally with new cancer therapies.”

Research and development expense for the second quarter of 2009 was $39.9 million compared with $21.7 million for the same period in 2008. The increase primarily related to increased spending in clinical studies and investment in R&D projects.

Selling, general and administrative (SG&A) expenses for the second quarter of 2009 were $47.1 million versus $53.5 million for the same period in 2008. SG&A expenses decreased primarily due to the elimination of commission payments under the previous co-promotion agreement, partially offset by international launch costs for ABRAXANE and an increase in sales and marketing costs.

On a GAAP basis, net loss for common shareholders for the second quarter of 2009 was $23.4 million, or $0.58 per share, compared with net loss for common shareholders of $84.1 million, or $2.10 per share, for the second quarter of 2008. Adjusted net loss for common shareholders for the second quarter of 2009 was $10.1 million, or $0.25 per share, compared with adjusted net income for common shareholders of $1.2 million, or $0.03 per share, for the second quarter of the prior year. Adjusted net (loss) income for common shareholders for the second quarters of 2009 and 2008 excludes amortization of acquired intangible assets, litigation costs, acquired in-process research and development, realized loss on marketable securities and non-cash stock-based compensation expense.

 

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Abraxis BioScience, Inc.

2009 Second Quarter Financial Results

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This excerpt taken from the ABII 8-K filed May 7, 2009.

Company Highlights:

 

 

 

ABRAXANE® Revenue of $71 Million for the First Quarter Since Re-acquiring Exclusive U.S. Marketing Rights

 

   

Company Reports Net Loss for Common Shareholders of $23 Million, or $0.57 Per Share, or Adjusted Net Loss for Common Shareholders of $6 Million, or $0.14 Per Share

 

   

ABRAXANE Data to be Presented at ASCO 2009 Includes Biomarker SPARC Correlative Data and Results of Combination Therapy Trials

LOS ANGELES, Calif. May 7, 2009 — Abraxis BioScience, Inc. (NASDAQ: ABII), a fully integrated biotechnology company, today reported unaudited financial results for the first quarter ended March 31, 2009.

As of January 2, 2009, the company re-acquired the exclusive rights to market ABRAXANE® (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 first quarter of 2009 was $72.6 million compared with $82.1 million for the first quarter of 2008. Net revenue for the first quarter of 2009 included $0.8 million of recognized deferred revenue compared with $10.2 million for the same period last year. Revenue from sales of ABRAXANE for the first quarter of 2009 was $70.6 million compared with $79.9 million for the same period in 2008, which included recognition of deferred revenue of $9.1 million. Excluding the recognition of deferred revenue, total ABRAXANE revenue for the first quarter of 2009 was $70.6 million compared with $70.8 million for the comparable period in 2008.

 

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Abraxis BioScience, Inc.

2009 First Quarter Financial Results

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Gross profit for the first quarter of 2009 was $63.5 million, or 87 percent of net revenue, compared with $73.5 million, or 90 percent of net revenue, for the first quarter of 2008. Excluding the recognition of deferred revenue, gross profit as a percentage of net revenue for the first quarter of 2009 was 87 percent versus 88 percent for the same period in 2008.

“Our revenue results for the quarter are derived solely by Abraxis BioScience’s sales and marketing team since re-acquiring the exclusive U.S. rights to market ABRAXANE at the beginning of the year,” said Lonnie Moulder, recently appointed President and Chief Executive Officer. “Since January, we have increased the size of our U.S. field force to 95 sales professionals and look forward to their impact in the market place.”

Mr. Moulder continued: “Ten preclinical studies were presented at the recent AACR meeting, some of which further elucidated how our novel nab technology may exploit the role of SPARC in tumor biology. We believe the body of data to be presented at ASCO in June will further advance this knowledge.”

Research and development expense for the first quarter of 2009 was $35.0 million compared with $20.8 million for the same period in 2008. The increase primarily related to increased spending in clinical studies and investment in R&D projects.

Selling, general and administrative (SG&A) expenses for the first quarter of 2009 were $42.5 million versus $45.3 million for the same period in 2008. SG&A expenses decreased primarily due to the elimination of commission payments under the co-promotion agreement, partially offset by international launch costs for ABRAXANE, increased spending for information systems infrastructure and an increase in sales and marketing costs.

Adjusted net loss for common shareholders was $5.6 million, or $0.14 per share, compared to adjusted net income for common shareholders of $10.4 million, or $0.26 per share, for the first quarter of the prior year. Adjusted net (loss) income for common shareholders for the first quarters of 2009 and 2008 excludes amortization of acquired intangible assets, realized loss on marketable securities and non-cash stock-based compensation expense. On a GAAP basis, net loss for common shareholders was $22.9 million, or $0.57 per share, compared to net income for common shareholders of $4.3 million, or $0.11 per share, for the first quarter of 2008.

 

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Abraxis BioScience, Inc.

2009 First Quarter Financial Results

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(Reconciliation tables are provided below)

This excerpt taken from the ABII 8-K filed Mar 3, 2009.

Fourth Quarter 2008 Highlights

Net revenue increased 1.5 percent to $92.2 million, compared with $90.8 million for the prior year period. Revenue from sales of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the fourth quarter of 2008 was $89.8 million, compared with $88.8 million for the same period in 2007. Net revenue included recognition of revenue of $9.9 million initially deferred relating to the co-promotion agreement with AstraZeneca and license agreements with Taiho of Japan and Green Cross of South Korea, similar to the 2007 fourth quarter.


Gross profit was $82.8 million, or 90 percent of net revenue, compared with $82.5 million, or 91 percent of net revenue, for the fourth quarter of 2007.

“In 2008, we made considerable achievements building our ABRAXANE commercial franchise on a global basis,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. “We established a new infrastructure in Europe and launched ABRAXANE in the United Kingdom, Australia, India, and UAE. With the early 2009 launch in Germany and approval to market ABRAXANE in China, Korea, together with the expected launches in the balance of the European Union (EU) countries, we have substantial additional market opportunities for 2009 and beyond. Coupled with several strategic acquisitions and a reinforced infrastructure, we believe we are well poised for continued success.

“On the clinical front, we will be running an unprecedented number of clinical studies in 2009 and beyond to broadly evaluate the application of our nab technology platform in a wide variety of tumor types,” continued Dr. Soon-Shiong. “Our strategy is informed by science, and we believe this is elucidating a fundamental change in cancer therapy. We are planning a significant release of data at ASCO this year, with data from studies in a variety of tumor types and indications, which we believe will validate the science surrounding the nab technology and begin to reveal a compelling story about cancer, cancer therapeutics, and a potential revolution in cancer patient care.”

The Abraxis clinical program currently consists of four Phase 3 clinical trials, three of which have been submitted under the IND for ABRAXANE (lung cancer, melanoma and pancreatic cancer), and one of which, a study in ovarian cancer, is being conducted by the company’s partner in Japan, Taiho Pharmaceutical Co., Ltd.; 65 investigator-initiated Phase 2 clinical trials; and, 16 Phase I studies.

Research and development expense was $37.0 million, or 40 percent of net revenue, compared with $27.3 million, or 30 percent of net revenue, for the same period in 2007. The increase primarily relates to increased spending in clinical studies and investment in R&D projects.

Selling, general and administrative expenses were $64.8 million, or 70 percent of net revenue, versus $52.1 million, or 57 percent of net revenue, for the same period in 2007.


The increase primarily reflected international launch costs for ABRAXANE, additional administration costs, and non-recurring spin-off related costs.

In the most recent quarter, the company recorded $158.9 million of re-acquisition costs related to the exclusive rights to market ABRAXANE in the U.S. The co-promotion agreement was cancelled effective January 2, 2009 and the company ceased all royalty payments related to sales after that date.

Adjusted net loss was $8.4 million, or $0.21 per share, compared to adjusted net income of $9.4 million, or $0.23 per diluted share, for the fourth quarter of last year. Adjusted net income (loss) for the fourth quarters of 2008 and 2007 excludes amortization of acquired intangible assets, the re-acquisition costs, litigation costs, realized loss on marketable securities and the impact of non-cash stock compensation expense. On a GAAP basis, and including the re-acquisition costs, net loss was $181.9 million, or $4.54 per share for the fourth quarter of 2008, compared with net loss of $5.2 million, or $0.13 per share, for the fourth quarter of 2007.

(Reconciliation tables are provided below)

This excerpt taken from the ABII 8-K filed Nov 14, 2008.

Third Quarter 2008 Highlights

Net revenue for the third quarter of 2008 increased 6.4 percent to $93.4 million, compared with $87.8 million for the prior-year period. Revenue from sales of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) increased 6.6 percent to $92.0 million, compared with $86.4 million for the same period in 2007. Net revenue included recognized deferred revenue of $9.2 million relating to a co-promotion agreement with AstraZeneca and license agreements with Taiho of Japan and Green Cross of South Korea, compared with $9.8 million of recognized deferred revenue for the same quarter last year.

“We continue to deliver strong sales of ABRAXANE and are pleased to be gaining an increasing share of the overall taxane market in the U.S., especially in second line metastatic breast cancer, where we achieved an all time high of 42 percent of the taxane market,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. “With recent and anticipated launches in several foreign markets and pending marketing

 


Abraxis BioScience, Inc.

2008 Third Quarter Financial Results

 

approvals in others, we are gratified that a growing number of patients worldwide are gaining access to this important novel chemotherapy. Additionally, we are developing new data on ABRAXANE in a variety of oncology settings and advancing our pipeline in several opportunities using our proprietary nab™ technology.”

Gross profit for the third quarter of 2008 was $82.3 million, or 88.1 percent of net revenue, compared with $76.2 million, or 86.8 percent of net revenue, for the same period in 2007.

Research and development expense for the third quarter of 2008 decreased to $24.1 million, or 25.8 percent of net revenue, compared with $28.7 million, or 32.7 percent of revenue, for the same period in 2007, primarily reflecting a licensing payment for a yet to be approved product, which was recognized in 2007.

Selling, general and administrative expenses for the third quarter of 2008 decreased to $53.2 million, or 57.0 percent of net revenue, versus $55.7 million, or 63.4 percent of net revenue, for the same period in 2007. The decrease primarily reflected lower shared marketing expenses under the co-promotion agreement, lower marketing personnel and program expenses, offset by higher co-promotion commission expense due to higher U.S. ABRAXANE revenues.

In the most recent quarter, the company recorded a $9.2 million impairment charge related to the anticipated sale of certain property, plant and equipment.

Interest income for the third quarter of 2008 was approximately $4.3 million, compared with interest income of approximately $162,000 in the prior-year period, due primarily to interest earned on the $700 million cash contribution to the company in connection with the separation from APP Pharmaceuticals, Inc. in November 2007.

Other expenses for the third quarter of 2008 increased to $5.5 million from $49,000, due primarily to a write-down of marketable securities whose decline in values were determined to be other than temporary.

 

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Abraxis BioScience, Inc.

2008 Third Quarter Financial Results

 

On a GAAP basis, and including one-time charges related to litigation costs and an impairment charge, the company reported a net loss of $15.1 million, or $0.38 per share, for the third quarter of 2008, compared with a net loss of $16.8 million, or $0.42 per share, for the third quarter of 2007.

The table below shows adjusted net income (loss) and adjusted net income (loss) per diluted share for the third quarters of 2008 and 2007, which excludes from net loss and net loss per diluted share, amortization of acquired intangible assets, litigation costs, impairment charge, realized loss on marketable securities, pre-launch costs associated with the company’s Phoenix manufacturing facility and the impact of non-cash stock compensation expense.

 

     Q3 2008    Q3 2007

Adjusted net income (loss)

   $8.6 million    $(7.9) million

Adjusted net income (loss) per diluted share

   $0.21    $(0.20)

(Reconciliation tables appear below.)

This excerpt taken from the ABII 8-K filed May 15, 2008.

FIRST QUARTER HIGHLIGHTS

During the first quarter of 2008, ABRAXANE received significant marketing approvals. In January, the company received approval from the EU Commission to market ABRAXANE for metastatic breast cancer. The company has begun building a senior team in Europe to lead the commercialization effort under the direction of Jean-Francois Gimonet, M.D., Vice President, European Operations. Maggie Massam has recently joined the European team as Senior Vice President, Global Marketing. In this role, Ms. Massam will have responsibility for global commercialization initiatives and ongoing marketing efforts for ABRAXANE®, supporting licensees and business partners. Prior to joining Abraxis, she managed the Account Services function as Prime Medica’s Director of Client Services, with overall responsibility for a client base including Roche, Novartis, AstraZeneca and Organon, and before that was Vice President, Account Group Supervisor at Cline Davis and Mann with responsibility for Amgen’s oncology and nephrology franchises.

In March, Abraxis’ partner in Japan, Taiho Pharmaceutical Co., filed a Japanese New Drug Application (J-NDA) with the Ministry of Health, Labor and Welfare in Japan to market ABRAXANE for the treatment of breast cancer. The submission was the result of close collaboration between the Taiho and Abraxis development teams and followed the completion of Phase I bridging studies in Japan.

 

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Abraxis BioScience, Inc.

2008 First Quarter Financial Results

 

Subsequent to the end of the quarter, ABRAXANE was granted marketing approval from the Korean FDA bringing to 34 the total number of countries where ABRAXANE is approved for marketing. Abraxis’ partner in Korea, Green Cross Corporation, expects to launch ABRAXANE in that country in the first quarter of 2009 following pricing approval.

ABRAXANE also is under active review in Australia, Russia and China by their respective regulatory agencies. The company anticipates approval in China in the second quarter of 2008, and in Russia and Australia in late 2008.

In April 2008, Abraxis completed the acquisition of Shimoda Biotech and Platco Technologies gaining a pipeline of novel cyclodextrin-based products and next-generation platinum-based oncology compounds. As part of the acquisition, Abraxis also gained a revenue stream from Shimoda’s Dyloject® product (diclofenac sodium solution for injection), an injectable painkiller for the treatment of post-surgical pain. Dyloject® was launched in the United Kingdom by Javelin Pharmaceuticals under an exclusive worldwide license from Shimoda.

This excerpt taken from the ABII 8-K filed Apr 1, 2008.

Highlights

   

ABRAXANE Revenue for Q4 2007 Increased 58% to $88.8 Million Versus $56.1 Million in Q4 2006

   

ABRAXANE Continues to be Fastest Growing Taxane and Achieves All Time High of 37% Market Share in Feb 2008

   

Company to Initiate Five Phase III Trials for ABRAXANE in 2008

LOS ANGELES, Calif. March 31, 2008 — Abraxis BioScience, Inc. (NASDAQ: ABII), a fully integrated biotechnology company, today reported financial results for the fourth quarter and full year ended December 31, 2007.

Full-year 2007 net revenue increased 83.1 percent to $333.7 million, compared with $182.3 million in 2006. Revenue from sales of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) grew 85.6 percent to $324.7 million in 2007 versus $174.9 million in 2006. ABRAXANE revenue included deferred recognized revenue of $36.4 million in 2007 and $18.2 million in 2006 as part of the June 2006 co-promotion agreement with AstraZeneca.

ABRAXANE continues to be the fastest growing taxane on the market. According to recent IntrinsiQ patient level data, ABRAXANE is the taxane leader in total metastatic breast cancer settings with an all time high market share of 37 percent. ABRAXANE gained nearly 11 percent market share from March 2007 to February 2008 in the 2nd line treatment of metastatic breast cancer, and continues to strengthen its leadership position in 3rd+ line treatment of MBC, increasing from 53 percent to 57 percent market share during that period.

“The increasing revenue and expanding global presence of ABRAXANE, combined with our registration studies for ABRAXANE both underway and planned, provide multiple opportunities for the continuing growth of Abraxis,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. “Abraxis is strengthening its market presence as a fully integrated biotechnology company with a solid nanotechnology platform.”


Abraxis BioScience, Inc.

2007 Fourth Quarter/Full Year Financial Results

 

Gross profit increased to $299.2 million in 2007, or 89.7 percent of net revenue, compared with $161.1 million, or 88.4 percent of net revenue, in 2006. Research and development expense totaled $88.7 million in 2007, compared with $63.1 million in 2006, with the increase primarily due to an upfront license payment, stock based compensation, and costs associated with Abraxis’ manufacturing facility in Phoenix, Arizona. Selling, general and administrative expenses were $230.0 million in 2007, versus $119.5 million in the prior year. This increase was primarily due to increases in sales commissions related to higher ABRAXANE revenues and shared marketing costs associated with the co-promotion agreement, legal expenses, and costs associated with the worldwide commercialization of ABRAXANE.

The following table shows adjusted net income and adjusted net income per share for 2007 and 2006, which exclude intangible amortization and other costs related to the April 2006 merger between American Pharmaceutical Partners, Inc. and American BioScience, Inc., non-cash stock compensation expense and pre-launch costs associated with the company’s Phoenix manufacturing facility. Adjusted net income in 2006 excludes in process research and development.

 

     2007    2006

Adjusted net income (millions)

   $ 10.0    $ 2.0

Adjusted net income per share

   $ 0.25    $ 0.05

(Reconciliation tables appear below.)

On a GAAP basis, the company reported a net loss of $41.6 million in 2007, or a net loss of $1.04 per share, versus a net loss of $124.6 million in 2006, or a net loss of $3.11 per share.

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