Abraxis BioScience Reports an Increase in Third Quarter Revenue of 19 Percent to $241 Million versus $203 Million in Prior Year Period.ABRAXANE Revenue Increased 65 Percent to 86.4 million and Remains the Fastest Growing Taxane in the Market
LOS ANGELES Los Angeles (lôs ăn`jələs, lŏs, ăn`jəlēz'), city (1990 pop. 3,485,398), seat of Los Angeles co., S Calif.; inc. 1850. -- Abraxis BioScience, Inc. (NASDAQ NASDAQ
in full National Association of Securities Dealers Automated Quotations
U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ABBI Advanced Breast Biopsy Instrument (ABBI)
Uses a rotating circular knife and thin heated electrical wire to remove a large cylinder of abnormal breast tissue.
Mentioned in: Fibrocystic Condition of the Breast ) today reported unaudited financial results for the third quarter ended September 30, 2007. Third quarter 2007 revenue increased 18.6 percent to $241.0 million, versus $203.1 million in the third quarter of 2006. Revenue for company-wide, hospital-based products in the third quarter of 2007 was $153.6 million, versus $150.1 million for the prior year quarter. For the third quarter of 2007, ABRAXANE([R]) (paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); protein-bound particles for injectable in·ject·a·ble
Capable of being injected. Used of a drug.
A drug or medicine that can be injected. suspension) (albumin-bound) revenue increased 65.1 percent to $86.4 million versus $52.3 million in the prior year period. Company-wide gross profit for the third quarter of 2007 increased 22.6 percent to $144.4 million, or 59.9 percent of total revenue, as compared to $117.7 million, or 58.0 percent of total revenue, in the same quarter of 2006.
The company posted adjusted net income and adjusted net income per diluted share, which both exclude merger-related items, non-cash stock compensation expense, non-recurring and other items, as follows:
On a reported basis and calculated in accordance with U.S. Generally Accepted Accounting Principles The standard accounting rules, regulations, and procedures used by companies in maintaining their financial records.
Generally accepted accounting principles (GAAP) provide companies and accountants with a consistent set of guidelines that cover both broad accounting (GAAP GAAP
See: Generally Accepted Accounting Principles
See generally accepted accounting principles (GAAP). ), the company reported a net loss of $8.4 million in the third quarter of 2007, or a loss of $0.05 per diluted share, versus net income of $13.6 million in the third quarter of 2006, or $0.08 per diluted share.
The attached table provides additional information regarding the basis for the adjusted net income per diluted share calculation, and the rationale for providing such information is included at the end of this release.
Segment Reporting segment reporting
A type of financial reporting in which the firm discloses information by identifiable industry segments. For example, Union Pacific Corporation reports revenues, income, assets, depreciation, and capital expenditures for each of four
On July 2, 2007, the company announced that its board of directors had approved a plan to separate its proprietary business - Abraxis Oncology and Abraxis Research (the new Abraxis BioScience or "ABI Abi (ā`bī) [short for Abijah], in the Bible, King Hezekiah's mother.
(Application Binary Interface) A specification for a specific hardware platform combined with the operating system. ") -- from its hospital-based business -- Abraxis Pharmaceutical Products (APP). The ABI segment focuses primarily on the company's internally developed proprietary product, ABRAXANE, and its proprietary pipeline. The APP segment, which will be known as APP Pharmaceuticals after the separation is complete, manufactures and markets one of the broadest portfolios of injectable drugs, including oncology, critical care and anti-infectives, and markets the company's anesthetic/analgesic products. The attached tables provide additional detail on the operating performance of the segments.
ABRAXANE revenue for the third quarter of 2007 increased 65.1 percent to $86.4 million, which included $77.3 million of net sales Net Sales
The amount a seller receives from the buyer after costs associated with the sale are deducted.
This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight , versus revenue of $52.3 million, which included $43.2 million in net sales, in the same period of 2006.
Based upon September 2007 NDC NDC National Drug Code
NDC NATO Defense College
NDC National Documentation Centre (National Hellenic Research Foundation, Athens, Greece)
NDC National Dairy Council
NDC National Democratic Congress and IMS (1) See IP Multimedia Subsystem.
(2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. data, ABRAXANE is still the fastest growing taxane in the market. According to according to
1. As stated or indicated by; on the authority of: according to historians.
2. In keeping with: according to instructions.
3. IMS, ABRAXANE unit demand in the third quarter of 2007 reached its highest unit volume since launch with an increase of 57 percent versus the third quarter of 2006.
ABI segment gross margin for the third quarter of 2007 was 86.9 percent compared to 85.5 percent for the same period in 2006. For the third quarter of 2007, selling and marketing expenses were $35.7 million, or 40.6 percent of revenue, versus $30.0 million, or 56.1 percent of revenue, in the prior year period. Research and development expense totaled $27.1 million in the third quarter of 2007 compared with $12.3 million in the prior year period.
Additional ABI Segment Updates
After the close of the third quarter, Abraxis announced the positive opinion from the European Committee for Human Medicinal Products (CHMP CHMP Committee for Medicinal Products for Human Use
CHMP Cultural Heritage Management Plan
CHMP Centrale Humanitaire Médico-Pharmaceutique
CHMP Certified Hazardous Materials Practitioner (Institute of Hazardous Materials Managers) ) for the approval of ABRAXANE for the treatment of metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.
Mentioned in: Coagulation Disorders
pertaining to or of the nature of a metastasis. breast cancer in Europe. This was based on clinical trial data that demonstrated ABRAXANE had significant superiority in the clinical endpoints of response rate, progression free survival and survival when compared with Taxol([R]) in metastatic breast cancer.
Abraxis has begun the process of establishing the necessary infrastructure to commercialize ABRAXANE across Europe. The launch of ABRAXANE in Europe will initially focus on the United Kingdom, France, Spain, Italy and Germany. Abraxis will leverage its current commercial organization as well as its medical affairs and regulatory affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas:
Abraxis and its commercial partner in India, Biocon Limited, also announced the approval of ABRAXANE in India for the treatment of metastatic breast cancer by the country's Drug Controller General. Commercial introduction of ABRAXANE in the Indian market is expected in 2008 following the completion of the appropriate importation certifications.
ABRAXANE remains under active review in Australia, Russia, Korea and China by their respective regulatory agencies.
The company continues to move forward with the development of ABRAXANE. As previously announced, Abraxis has reached a definitive agreement with the FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. under the Special Protocol Assessment process on the Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial design of the company's pivotal study with for the treatment of non-small cell lung cancer Lung Cancer, Non-Small Cell Definition
Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors.
There are two kinds of lung cancers, primary and secondary. in the first-line setting in patients with stage IIIb and IV disease. The primary endpoint of the study is overall response rate, and enrollment will begin in the fourth quarter of 2007. Special Protocol Assessments have also been submitted to the FDA for the worldwide head-to-head Phase III registration trial comparing weekly ABRAXANE to every three week Taxotere([R]) (docetaxel) for the treatment of first-line metastatic breast cancer and the Phase III melanoma trial.
Hospital-based product revenue for the APP segment in the third quarter of 2007 increased 2.3 percent to $153.2 million versus $149.8 million in the same quarter of 2006. The increased revenues in the third quarter of 2007 included sales of $44.2 million from the anesthetic/analgesic products, which are grouped under critical care. APP revenue for 2007 is now expected to be in the lower end of the range of guidance previously provided, which would be an increase of approximately 9 percent over revenues in 2006.
Gross margin for the third quarter of 2007 was 47.6 percent, excluding amortization associated with the purchase of the anesthetic/analgesic products, compared to 54.7 percent in the same quarter of 2006. The decrease in gross margin was primarily a result of higher costs associated with extended plant maintenance at the Melrose Park Melrose Park, village (1990 pop. 20,859), Cook co., NE Ill., an industrial suburb of Chicago; inc. 1893. It has large railroad yards and shops, steel mills, and factories that make a wide variety of products. facility, product mix and higher distribution-related costs. In the third quarter of 2007, selling and marketing expenses were $4.3 million, or 2.8 percent of revenue, versus $3.5 million, or 2.3 percent of revenue, in the prior year period.
Research and development expense totaled $10.6 million for the third quarter of 2007 compared to $7.9 million in the prior year period. The increase was primarily due to launch expenses associated with the Puerto Rico Puerto Rico (pwār`tō rē`kō), island (2005 est. pop. 3,917,000), 3,508 sq mi (9,086 sq km), West Indies, c.1,000 mi (1,610 km) SE of Miami, Fla. manufacturing facility. Commercial operations of the Puerto Rico facility in Barceloneta began in the fourth quarter of 2007 with the release of doxycycline doxycycline /doxy·cy·cline/ (dok?se-si´klen) a semisynthetic broad-spectrum tetracycline antibiotic, active against a wide range of gram-positive and gram-negative organisms; used also as d. calcium and d. hyclate. subsequent to the positive conclusion of the FDA inspection of the facility. Two additional approvals are anticipated by the end of the year at this facility.
The FDA has concluded its inspection of the Melrose Park facility which resulted in a positive evaluation. The issues previously raised have been addressed to the satisfaction of the FDA, and the facility is now within compliance.
In the third quarter, APP launched Cefotetan Disodium for Injection. Cefotetan, which is the generic equivalent of AstraZeneca's Cefotetan([R]), has the longest half-life of any first or second generation cephalosporin cephalosporin (sĕf'əlōspôr`ĭn), any of a group of more than 20 antibiotics derived from species of fungi of the genus Cephalosporium and closely related chemically to penicillin. Cephalosporins, e.g. and offers surgeons a convenient single-dose option for surgical prophylaxis prophylaxis (prō'fĭlăk`sĭs), measures designed to prevent the occurrence of disease or its dissemination. Some examples of prophylaxis are immunization against serious diseases such as smallpox or diphtheria; quarantine to confine and secondary infections. APP is the only supplier of this drug in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. since AstraZeneca discontinued manufacturing.
APP also launched Doxorubicin Hydrochloride doxorubicin hydrochloride Warning - Hazardous drug!
Adriamycin PFS, Adriamycin RDF, Rubex
Pharmacologic class: Anthracycline
Therapeutic class: Antibiotic antineoplastic Injection, the generic equivalent of Adriamycin([R]), which is owned by Bedford Laboratories GmbH. Doxorubicin doxorubicin /doxo·ru·bi·cin/ (dok?so-roo´bi-sin) an antineoplastic antibiotic, produced by Streptomyces peucetius, which binds to DNA and inhibits nucleic acid synthesis; used as the hydrochloride salt and as a liposome-encased is commonly used in the treatment of a wide range of cancers.
In October 2007, the Company received tentative approval for Irinotecan Hydrochloride irinotecan hydrochloride Warning - Hazardous drug!
Campto (UK), Camptosar
Pharmacologic class: Topoisomerase inhibitor
Therapeutic class: Hormonal antineoplastic
Injection and approvals for Epirubicin Hydrochloride epirubicin hydrochloride Warning - Hazardous drug!
Pharmacologic class: Anthracycline
Therapeutic class: Antibiotic antineoplastic
Injection (in four dosage forms), liquid and lyophilized ly·oph·i·lize
tr.v. ly·oph·i·lized, ly·oph·i·liz·ing, ly·oph·i·liz·es
To freeze-dry (blood plasma or other biological substances).
[lyophil(ic) + -ize. Fludarabine Phosphate. The combined branded market sales in 2006 for these drugs are in excess $750 million.
Irinotecan Hydrochloride Injection is the generic equivalent of Camptosar([R]) Injection manufactured by Pfizer Inc. As one of the only companies to receive a tentative approval, APP is securing contracts and expects to commence marketing of this product upon patent expiry in February 2008.
The lyophilized version of Fludarabine Phosphate is the generic equivalent of Fludara([R]), which is distributed by Bayer HealthCare Pharmaceuticals Inc., and the liquid version of fludarabine, is the equivalent of Fludarabine Phosphate for Injection, which is marketed by Teva Parenteral parenteral /pa·ren·ter·al/ (pah-ren´ter-al) not through the alimentary canal, but rather by injection through some other route, as subcutaneous, intramuscular, etc.
1. Medicines, Inc. APP expects to launch in the fourth quarter of 2007.
Four dosage forms of Epirubicin Hydrochloride Injection were approved by the FDA, two of which are unique codes and not currently available on the market. The remaining two codes are marketed by Pfizer Inc. as Ellence([R]) and one additional company as a generic. Epirubicin belongs to a class of drugs called anthracyclines and is the foundation of many chemotherapy regimens Chemotherapy regimens are often identified with acronyms, identifying the agents used in combination. Unfortunately, the letters used are not consistent across regimens, and in some cases (for example, "BEACOPP") the same letter is used to represent two different treatments. . APP expects to launch in the fourth quarter of 2007.
APP currently has over 60 product candidates in various stages of development, including 29 ANDAs (including tentative approvals) pending with the FDA.
General and Administrative Expenses
Company-wide, general and administrative expenses for the third quarter of 2007, excluding selling and marketing expenses, were $55.7 million, or 23.1 percent of revenue, versus $22.9 million, or 11.3 percent of revenue, for the same period in 2006. The increase was due primarily to non-recurring legal expenses, separation-related costs and the hiring of additional personnel in preparation for the separation.
Conference Call Information
On Thursday, November 8, 2007, the company will host a conference call with interested parties beginning at 8:30 a.m. PST/11:30 a.m. EST EST electroshock therapy.
electroshock therapy to review its results of operations for the third quarter of 2007 and the upcoming separation. 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 websites for approximately six months beginning shortly after the conclusion of the call.
Non-GAAP Financial Measures
Adjusted net income per diluted share is a non-GAAP financial measure comprised of reported diluted earnings per share diluted earnings per share
An earnings measure calculated by dividing net income less preferred stock dividends for a period by the average number of shares of common stock that would be outstanding if all convertible securities were converted into shares of excluding the impact of merger-related non-cash amortization of intangible assets, direct merger and transaction-related costs, non-cash stock compensation expense, minority interests, non-cash amortization of acquired intangible assets, and separation-related costs. The company believes that its presentation of non-GAAP financial measures provides 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 Financial planning
Evaluating the investing and financing options available to a firm. Planning includes attempting to make optimal decisions, projecting the consequences of these decisions for the firm in the form of a financial plan, and then comparing future performance against 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. A reconciliation of GAAP net income to adjusted net income for the three and nine months ending September 30, 2007 and September 30, 2006 is included with this press release.
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 Adjuvant chemotherapy
Treatment of the tumor with drugs after surgery to kill as many of the remaining cancer cells as possible.
Mentioned in: Neuroblastoma . Prior therapy should have included an anthracycline unless clinically contraindicated. For the full prescribing information for ABRAXANE([R]) please visit www.abraxane.com.
About Abraxis BioScience, Inc.
Abraxis BioScience, Inc. is an integrated global biopharmaceutical company dedicated to meeting the needs of critically ill patients. The company develops, manufactures and markets one of the broadest portfolios of injectable products and leverages revolutionary technology such as its nab[TM] platform to discover and deliver breakthrough therapeutics that transform the treatment of cancer and other life-threatening diseases. The first FDA approved product to use this nab platform, ABRAXANE([R]), was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the NASDAQ Global Market under the symbol ABBI. For more information about the company and its products, please visit www.abraxisbio.com.
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 proposed separation of the proprietary product business from the hospital-based business, 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. 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, risks that the proposed transaction disrupts current plans and operations and the potential difficulties in employee retention; the inability to recognize the benefits of the transactions contemplated by the separation of the businesses; 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 Form 10-K
A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.
See 10-K. for the year ended December 31, 2006 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.
Taxol([R]) is a registered trademark of Bristol Myers-Squibb Company.
Taxotere([R]) is a registered trademark of Sanofi Aventis.
Camptosar([R]) and Ellence are registered trademarks of Pfizer Inc.
Cefotan([R]) is a registered trademark of AstraZeneca, LLC (Logical Link Control) See "LANs" under data link protocol.
LLC - Logical Link Control .
Adriamycin([R]) is a registered trademark of Bedford Laboratories GmbH.
Fludara([R]) is a registered trademark of Bayer HealthCare Pharmaceuticals, Inc.
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