About Auxilium
Auxilium Pharmaceuticals to Present at the 2011 Citi Annual Global Healthcare Conference
Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2010 Financial Results and Operational Highlights
Auxilium Pharmaceuticals, Inc a specialty biopharmaceutical company, today announced financial results and operational highlights for the quarter ended September 30, 2010. For the third quarter of 2010, Auxilium reported net revenues of $53.6 million compared to net revenues of $42.1 millionin the third quarter of 2009. The net loss for the third quarter of 2010 was $(12.8) million, or $(0.27) per share, compared to a net loss of $(14.9) million, or $(0.35) per share, reported for the third quarter of 2009.
"In the third quarter, we continued to make advances with both of our marketed products. We saw a significant increase in the number of sites using XIAFLEX for the treatment of Dupuytren's contracture, which helped support the peer to peer discussions of XIAFLEX at the meeting of the American Society for Surgery of the Hand in October. We also finished preparation for the recent initiation of our XIAFLEX phase III global development program for the treatment of Peyronie's disease, a potential second indication for XIAFLEX," said Armando Anido, Chief Executive Officer and President of Auxilium. "Testim U.S. net revenue continued to grow with a 17.9% increase year over year in the third quarter, and we believe that the U.S. Food and Drug Administration's response to Abbott Laboratories' Citizen Petition on generic testosterone gel products is a significant, positive event for Testim."
Auxilium receives USPTO patent for XIAFLEX product
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL), a specialty biopharmaceutical company, today announced that the United States Patent and Trademark Office ("USPTO") issued U.S. Patent No. 7,811,560 claiming, among other things, purified collagenase, the active component in Auxilium's product XIAFLEX® (collagenase clostridium histolyticum). The patent entitled "COMPOSITIONS AND METHODS FOR TREATING COLLAGEN-MEDIATED DISEASES" is expected to expire in July 2028. The Company also announced that it has filed continuation applications with the USPTO, which, if granted, may expand the scope of patent claims covering XIAFLEX.
The patent's independent claims recite a drug product, a process for producing the drug product, and pharmaceutical formulations comprising the drug product. The claimed drug product consists of isolated and purified clostridial collagenase I and II, with a mass ratio of about 1:1, and purity of at least 97% as measured by reverse phase high-performance liquid chromatography. The process claims include processes for making the drug product. The pharmaceutical formulation claims recite the drug product with appropriate excipient(s). Dependent claims recite particular additional components of the drug product and pharmaceutical formulations, as well as additional process steps.
"We are very pleased that XIAFLEX now has patent protection which we expect will expire in July 2028," said Armando Anido, Chief Executive Officer and President of Auxilium Pharmaceuticals. "With one approved indication for XIAFLEX, a second in late-stage clinical trials, and many more potential indications in the pipeline, we believe that extending our patent protection for the next 18 years is an important accomplishment."
Analyst Research on China-Biotics Inc. and Auxilium Pharmaceuticals Inc. -- Probiotics are Latest Pharma Trend
The rising demand for probiotics is one of the most interesting trends amongst pharmaceutical companies. Probiotics are helpful bacteria and are often used to help the immune system and aid digestion. Probiotics are most commonly found in yogurts, baby formulas and pills but the uses are expanding. To date, the probiotics industry has grown almost 20% in the past year with Asian demand leading the way.
While the global economy still recovers, the growing demand for probiotics is an exciting trend for the pharmaceuticals industry. The fact that probiotics can be found in everyday products like yogurt and dairy products distinguishes it from the typically medicinal usage of pharmaceutical products.
Probiotics also differ from typical pharmaceutical products in the sense that new variants don't linger for years in extensive multistage drug trials. Probiotics go from development to the market at a much faster rate. In a recovering economy where time is critical, probiotics are an increasingly marketable and profitable product and one company making great strides as an emerging producer of probiotics is China-Biotics Inc. Investors looking for complimentary research on China-Biotics Inc.
China-Biotics Inc. will be releasing its Q3 2010 results on November 15th. Another player in the drug related products set to release its earnings late this month is Auxilium Pharmaceuticals Inc. Investors looking for free research on Auxilium Pharmaceuticals Inc.
Auxilium Pharmaceuticals Inc. Reports Operating Results
Auxilium Pharmaceuticals Inc. is a specialty pharmaceutical company that develops and markets products for urology and sexual health. Auxilium markets Testim 1% a topical testosterone gel for the treatment of hypogonadism. Auxilium is developing additional Testim line extensions as well as other products for urology and sexual health including an enzyme in Phase II for the treatment of Peyronie's Disease that may also prove useful for the treatment of Dupuytren's Disease. Auxilium Pharmaceuticals Inc. has a market cap of $1.01 billion; its shares were traded at around $23.85 with and P/S ratio of 8.1.
Highlight of Business Operations:Net revenues. Net revenues increased $7.6 million, or 28%, to $34.7 million for the quarter ended March 31, 2009 from $27.1 million for the comparable 2008 period. This increase in net revenues resulted primarily from growth in Testim demand resulting from increased prescriptions and increases in pricing, net of discounts, rebates and coupons. According to National Prescription Audit (“NPA”) data from IMS Health (“IMS”), a pharmaceutical market research firm, Testim total prescriptions for the first quarter of 2009 grew 14.1% over the comparable period of 2008. We believe that Testim prescription growth in the 2009 period over the 2008 period was driven by physician and patient acceptance that
Testim provides better patient outcomes, the shift in prescriptions away from the testosterone patch product and the other gel product to Testim, and the continued focus of our sales force on the promotion of Testim to urologists, endocrinologists and select primary care physicians. Net revenues for the first quarter of 2009 benefited from price increases having a cumulative impact of 9% over the comparable 2008 period. Net revenues for the first quarter of 2009 and 2008 include $0.4 million and zero, respectively, of international product shipments of Testim and $0.8 million and $0.2 million, respectively, of revenues related to Testim up-front and milestone payments. Net revenues for the first quarter of 2009 also include amortization of the deferred revenue resulting from our collaboration agreement with Pfizer, Inc. (the “Pfizer Agreement”). Total product sales allowances for the first quarter of 2009 and 2008 amounted to 21.8% and 19.4%, respectively, of total sales of Testim in the U.S. The increase in this 2009 period over the comparable period in 2008 results from an increase in coupon usage for new patients.
Since inception through March 31, 2009, we have financed our product development, operations and capital expenditures primarily from private and public sales of equity securities. Since inception through March 31, 2009, we received net proceeds of approximately $284.6 million from private and public sales of equity securities and the exercise of stock options and warrants. We had $90.2 million and $113.9 million in cash and cash equivalents as of March 31, 2009 and December 31, 2008, respectively.
Cash used in operations was $21.1 million and $13.5 million for the three months ended March 31, 2009 and 2008, respectively. Cash used in operations for the three months ended March 31, 2009 resulted primarily from operating losses and the payment of costs accrued in 2008, including $6.4 million to BioSpecifics Technologies Corp for their share of the $75 million received under the Pfizer Agreement and approximately $3.0 million in transaction related costs associated with this agreement. Cash used in
Cash used in investing activities was $3.1 million for the three months ended March 31, 2009 compared to cash provided of $0.8 million for the three months ended March 31, 2008. The cash impact of investing activities relates primarily to our investments in property and equipment and, in 2008, to the net effect of purchases and redemptions of short-term investments.
Cash provided by financing activities was $0.4 million and $0.9 million for the three months ended March 31, 2009 and 2008, respectively. Cash provided by financing activities in both periods results primarily from cash receipts from stock option exercises, net of treasury shares acquired in satisfaction of tax withholding requirements on stock awards to certain officers and employees.
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