Home > Press > Abraxis BioScience Reports Financial Results for the Second Quarter of 2008
Abstract:
Abraxis BioScience, Inc. (NASDAQ: ABII), a fully integrated biotechnology company, today reported unaudited financial results for the second quarter ended June 30, 2008.
Net revenue for the second quarter of 2008 was $77.6 million, compared with $83.2 million for the prior year period. Revenue from sales of ABRAXANE(R) (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) was $73.8 million for the second quarter of 2008, compared with $78.7 million for the same period in 2007. Revenue for the most recent quarter was impacted by a delay of product orders that had been anticipated for the period. Net revenue for the second quarter of 2008 included recognized deferred revenue of $10.2 million relating to the co-promotion agreement with AstraZeneca and the 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.
According to recent IntrinsiQ data regarding total ABRAXANE usage in June 2008, 1st and 2nd line share of all ABRAXANE patient usage reached an all time high of 54 percent. This has increased 23 percent from 31 percent of total patient usage of ABRAXANE in the 1st and 2nd line settings in January 2006. In the 3rd line+ taxane setting of the metastatic breast cancer market, ABRAXANE remained the leader, holding 54 percent of the market in this setting in June 2008. In 2nd line metastatic breast cancer, ABRAXANE share of the taxane market maintained its all time high of 37 percent in June 2008. ABRAXANE share of the taxane market in 1st line metastatic breast cancer represented 19 percent of the market in June 2008. Finally, ABRAXANE share of the taxane market in all metastatic breast cancer settings was 33 percent in June 2008.
Usage of ABRAXANE in combination with Avastin in metastatic breast cancer continues to increase, representing 39 percent of all ABRAXANE usage in June 2008, compared with 8.3 percent in January 2006. ABRAXANE in combination with Avastin, the #1 regimen used, represented 18 percent of the 2nd line total taxane market and had a share greater than any monotherapy.
According to IMS, monthly unit demand for ABRAXANE has increased for two consecutive quarters. ABRAXANE demand volume for the quarter ended June 30, 2008 reflected 4% growth over the prior quarter and represented the largest historical demand total for a quarter.
"Thus far this year we have obtained approval to market ABRAXANE in a total of 32 countries, including the EU, China and Korea, and launched ABRAXANE in the Indian market with our partner Biocon. ABRAXANE is now approved for marketing in a total of 35 countries, and our global roll-out is progressing as planned," said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. "On the clinical front, we unveiled data from over 25 company and investigator-sponsored studies at various congresses. We are building a large body of data that supports the use of ABRAXANE in a variety of oncology settings and in combination with targeted agents as well as other chemotherapeutic agents. We intend to maintain our momentum on the business and clinical fronts and look forward to reporting a continuing record of achievements as the year unfolds."
Gross profit for the second quarter of 2008 was $67.7 million, or 87.2 percent of net revenue, compared with $76.3 million, or 91.7 percent of net revenue, for the same period in 2007. The decrease reflected lower production volumes.
Research and development expense for the second quarter of 2008 totaled $21.7 million, or 28.0 percent of net revenue, compared with $16.9 million, or 20.4 percent of revenue, for the same period in 2007. The increase was primarily due to higher R&D costs related to the operation of the Phoenix, Arizona plant that was acquired in July 2007, and increases in spending related to clinical trials and research projects.
Selling, general and administrative expenses for the second quarter of 2008 were $52.7 million, or 67.8 percent of net revenue, versus $73.2 million, or 88.0 percent of net revenue, for the same period in 2007. The decrease primarily reflected a legal charge taken in the second quarter of 2007, as well as lower shared marketing expenses under the AstraZeneca co-promotion agreement and lower marketing personnel and program expenses.
Abraxis recorded a $13.9 million one-time charge for acquired in-process research and development in connection with the company's acquisition of Shimoda Biotech and Platco Technologies in April 2008. Also in the second quarter of 2008, the company recorded a one-time charge of approximately $58.3 million, which has not been paid, related to litigation with Elan Pharmaceutical Int'l Ltd. Abraxis is pursuing post-trial motions and will appeal the judgment of the District Court of Delaware.
Interest income and other in the second quarter of 2008 was approximately $4.8 million, compared with interest income and other of approximately $43,000 in the prior-year period, due primarily to the receipt of $700 million contributed to the company in connection with the separation from APP Pharmaceuticals, Inc. in November 2007.
On a GAAP basis, and including the one-time charges related to litigation costs and acquired in-process research and development, the company reported a net loss of $84.1 million, or $2.10 per share, for the second quarter of 2008, compared with a net loss of $14.0 million, or a loss of $0.35 per share, for the second quarter of 2007.
The table below shows adjusted net income (loss) and adjusted net income (loss) per diluted share for the second quarters of 2008 and 2007, which excludes in-process research and development charges, amortization of acquired intangible assets, litigation costs, pre-launch costs associated with the company's Phoenix manufacturing facility and non-cash stock compensation expense.
1H 2008 1H 2007 (millions) (millions) ---------- ---------- Adjusted net income (loss) $15.9 $ (1.4) Adjusted net income (loss) per diluted share $0.39 $(0.03) (Reconciliation tables appear below.)
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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(TM) platform. The first FDA approved product to use this nab(TM) platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the NASDAQ Global Market under the symbol ABII.
About ABRAXANE(R)
The U.S. Food and Drug Administration approved ABRAXANE(R) 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(R) please visit www.abraxane.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 approval and launch of ABRAXANE in Europe and Korea. 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, 2007 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.
Avastin(R) is a registered trademark of Genentech, Inc.
Gemzar(R) is a registered trademark of Eli Lilly and Company
Abraxis BioScience, Inc. Condensed Consolidated and Combined Statements of Operation (1) (Unaudited, in thousands, except per share amounts) Three Months Ended Six Months Ended June 30, June 30, ------------------- ------------------- 2008 2007 2008 2007 --------- --------- --------- --------- Abraxane revenue $ 73,833 $ 78,670 $153,765 $149,553 Other revenue 3,789 4,547 5,999 5,557 --------- --------- --------- --------- Net revenue 77,622 83,217 159,764 155,110 Cost of sales 9,945 6,899 18,552 14,558 --------- --------- --------- --------- Gross profit 67,677 76,318 141,212 140,552 Operating expenses Research and development 21,693 16,947 42,515 32,660 Selling, general and administrative 52,666 73,209 97,966 122,247 Litigation costs 58,257 - 58,257 - Acquired in-process research and development charge 13,900 - 13,900 - Amortization of acquired intangible assets 9,958 9,653 19,611 19,305 Equity in net loss (income) of Drug Source Co, LLC (24) (1,178) 224 (1,896) --------- --------- --------- --------- Total operating expenses 156,450 98,631 232,473 172,316 --------- --------- --------- --------- Loss from operations (88,773) (22,313) (91,261) (31,764) Interest income and other 4,829 43 11,651 339 --------- --------- --------- --------- Loss before income taxes (83,944) (22,270) (79,610) (31,425) Provision (benefit) for income taxes 199 (8,299) 224 (11,783) --------- --------- --------- --------- Net loss $(84,143) $(13,971) $(79,834) $(19,642) ========= ========= ========= ========= Basic and diluted net loss per common share $ (2.10) $ (0.35) $ (2.00) $ (0.49) ========= ========= ========= ========= Basic and diluted weighted average common shares outstanding 40,018 39,990 40,007 39,990 ========= ========= ========= ========= The composition of stock-based compensation included above is as follows: Cost of sales $ 114 $ 412 $ 165 $ 927 Research and development 1,209 1,218 2,399 3,612 Selling, general and administrative 2,786 2,325 4,539 5,919 --------- --------- --------- --------- Total stock-based compensation $ 4,109 $ 3,955 $ 7,103 $ 10,458 ========= ========= ========= ========= Selected ratios as a percentage of net revenue: Gross margin 87.2% 91.7% 88.4% 90.6% Research and development 28.0% 20.4% 26.6% 21.1% Selling, general and administrative 67.8% 88.0% 61.3% 78.8% (1) The consolidated and combined financial information reflects the consolidated operations of Abraxis BioScience and its subsidiaries as an independent, publicly-traded company as of and subsequent to November 13, 2007 and a combined reporting entity comprising the assets and liabilities that constituted the proprietary business of Old Abraxis for periods prior to November 13, 2007. The consolidated and combined financial information for periods prior to and including November 13, 2007 may not be indicative of our future performance and do not necessarily reflect what our consolidated and combined results of operations, financial position and cash flows would have been had we operated as an independent, publicly-traded company during those periods. -0- Abraxis BioScience, Inc. GAAP to Adjusted Net Income (Loss) Per Share Reconciliation (Unaudited, in thousands, except per share amounts) Adjusted net income (loss) and adjusted net income (loss) per share are defined as net income (loss) and net income (loss) per share, respectively, in each case excluding in-process research and development charges, amortization of acquired intangible assets, litigation costs, Phoenix pre-launch costs 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 are in addition to, and not a substitute for or superior to, measures of financial performance calculated in accordance with GAAP. Reconciliation of net income (loss) and net income (loss) per share to adjusted net income (loss) and adjusted net income (loss) per share for each of the three and six months ended June 30, 2008 and 2007 is below: Three Months Ended Six Months Ended June 30, June 30, ------------------- ------------------- 2008 2007 2008 2007 --------- --------- --------- --------- Net loss $(84,143) $(13,971) $(79,834) $(19,642) Amortization of acquired intangible assets 8,786 5,929 13,872 11,858 Acquired in-process research and development charge (a) 13,900 - 13,900 - Litigation costs (b) 58,257 - 58,257 - Phoenix pre-launch costs (c) 3,209 - 4,645 - Stock compensation expense 3,625 2,429 5,024 6,424 --------- --------- --------- --------- Adjusted net income (loss) $ 3,634 $ (5,613) $ 15,864 $ (1,360) ========= ========= ========= ========= Adjusted net income (loss) per diluted share (d) $ 0.09 $ (0.14) $ 0.39 $ (0.03) ========= ========= ========= ========= Weighted - average common diluted shares outstanding 40,217 39,990 40,197 39,990 ========= ========= ========= ========= Net loss per share $ (2.09) $ (0.35) $ (1.99) $ (0.49) Amortization of acquired intangible assets 0.22 0.15 0.35 0.30 Acquired in-process research and development charge (a) 0.34 - 0.34 - Litigation costs (b) 1.45 - 1.45 - Phoenix pre-launch costs (c) 0.08 - 0.12 - Stock compensation expense 0.09 0.06 0.12 0.16 --------- --------- --------- --------- Adjusted net income (loss) per diluted share $ 0.09 $ (0.14) $ 0.39 $ (0.03) ========= ========= ========= ========= -0- Abraxis BioScience, Inc. GAAP to Adjusted Pretax Net Income Reconciliation (unaudited, in thousands) Three Months Ended Six Months Ended June 30, June 30, ------------------- ------------------- 2008 2007 2008 2007 --------- --------- --------- --------- Loss before income tax $(83,944) $(22,270) $(79,610) $(31,425) Pretax amortization of acquired intangible assets 9,958 9,653 19,611 19,305 Acquired in-process research and development charge (a) 13,900 - 13,900 - Litigation costs (b) 58,257 - 58,257 - Phoenix pre-launch costs (c) 3,637 - 6,566 - Stock compensation expense 4,109 3,955 7,103 10,458 --------- --------- --------- --------- Adjusted income (loss) before income tax $ 5,917 $ (8,662) $ 25,827 $ (1,662) ========= ========= ========= ========= (a) In connection with the purchase of Shimoda Biotech and Platco Technologies in April 2008, we acquired certain research and development projects that were required to be expensed in accordance with generally accepted accounting principles. Approximately $13.9 million of the purchase price was expensed as in-process research and development for projects that, as of the acquisition date, had not yet reached technological or regulatory feasibility and had no alternative future uses in their current states. (b) On June 13, 2008, a jury ruled that we infringed upon one of Elan's patents, which runs until 2011, and awarded Elan $55.2 million in damages for sales of Abraxane(R) through the judgment date. We are in the process of appealing the jury ruling. As of June 30, 2008, we recorded $58.3 million for this matter, which includes $2.2 million of pre-judgment interest. (c) Represents pre-launch costs associated with our Phoenix, Arizona manufacturing facility. (d) Taxable adjustments to net loss were tax effected using an incremental tax rate of 38.58% -0- Abraxis BioScience, Inc. Condensed Consolidated and Combined Balance Sheets (In thousands) June 30, December 31, 2008 2007 ----------- ------------ Assets (Unaudited) Current assets: Cash and cash equivalents $ 656,969 $ 705,125 Accounts receivable, net of chargebacks 32,192 43,944 Related party receivable 2,516 1,958 Inventories 67,641 73,677 Prepaid expenses and other current assets 14,421 18,572 Deferred income taxes 58,562 33,696 ----------- ------------ Total current assets 832,301 876,972 Property, plant and equipment, net 152,644 145,120 Investment in Drug Source Company, LLC 9,051 9,275 Intangible assets, net of accumulated amortization 193,984 205,231 Goodwill 241,361 241,361 Other non-current assets 33,147 24,296 ----------- ------------ Total assets $1,462,488 $1,502,255 =========== ============ Liabilities and stockholders' equity Current liabilities: Accounts payable $ 26,454 $ 33,579 Accrued liabilities 44,113 54,927 Accrued litigation settlement 58,257 - Accounts payable to related parties - 6,986 Income taxes payable - 5,010 Deferred revenue 42,501 41,289 ----------- ------------ Total current liabilities 171,325 141,791 ----------- ------------ Deferred income taxes, non-current 57,262 32,396 Long-term portion of deferred revenue 99,257 121,138 Other non-current liabilities 14,844 9,543 ----------- ------------ Total liabilities 342,688 304,868 Stockholders' equity Common stock 40 40 Additional paid-in capital 1,196,316 1,192,461 Retained earnings (deficit) (75,752) 4,082 Accumulated other comprehensive income (loss) (804) 804 ----------- ------------ Total stockholders' equity 1,119,800 1,197,387 ----------- ------------ Total liabilities and stockholders' equity $1,462,488 $1,502,255 =========== ============
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Contacts:
Investors and Media Inquiries:
Abraxis BioScience, Inc.
Daniel Saks
Vice President,
Investor Relations and Corporate Communications
310.405.7417
or
Pondel Wilkinson Inc.
Rob Whetstone
310.279.5963
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