Key Developments: Auxilium Pharmaceuticals Inc (AUXL.OQ)
19.65USD
1 Aug 2013
$1.29 (+7.03%)
$18.36
$19.58
$20.93
$18.65
788,685
203,044
$26.55
$13.88
Latest Key Developments (Source: Significant Developments)
Auxilium Pharmaceuticals Inc Narrows FY 2013 Revenue Guidance TO A Range In Line WIth Analysts Estimates
Auxilium Pharmaceuticals Inc updated its fiscal 2013 Guidance and it expects total revenues of $363 million to $405 million . According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $373 million for fiscal 2013. Full Article
Auxilium Pharmaceuticals Inc And Swedish Orphan Biovitrum AB Enter Collaboration Agreement For XIAPEX In 71 Eurasian And African Countries
Auxilium Pharmaceuticals Inc and Swedish Orphan Biovitrum AB announced that they have entered into a long-term collaboration for the development, supply and commercialization of XIAPEX (collagenase clostridium histolyticum), a first-in-class biologic for the treatment of Dupuytren's contracture. In addition, work is on-going to file for approval of XIAPEX for the treatment of Peyronie's disease in the EU. Under the terms of the collaboration agreement, Sobi will receive exclusive rights to commercialize XIAPEX for these two indications, subject to applicable regulatory approvals, in 28 EU member countries, Switzerland, Norway, Iceland, 18 Central Eastern Europe/Commonwealth of Independent countries, including Russia and Turkey, and 22 Middle Eastern & North African countries. Since 2011, XIAPEX has been approved for the treatment of Dupuytren's contracture in 28 EU member countries, Switzerland, and Norway. Sobi, via its Partner Products business unit, will be primarily responsible for the applicable regulatory, clinical and commercialization activities for XIAPEX in Dupuytren's contracture and Peyronie's disease in these countries. XIAFLEX/XIAPEX has been approved by the U.S. Food and Drug Administration, Health Canada and the European Medicines Agency as a treatment for Dupuytren's contracture for adult patients with a palpable cord, and is also in phase III development in Japan. Full Article
Auxilium Pharmaceuticals Inc Raises FY 2013 Guidance-Conference Call
Auxilium Pharmaceuticals Inc announced that for fiscal 2013, it expects total revenues of $360 million to $415 million. According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $348 million for fiscal 2013. Full Article
Auxilium Pharmaceuticals Inc Completes Acquisition Of Actient Holdings LLC
Auxilium Pharmaceuticals Inc announced that it has completed the acquisition of Actient Holdings LLC (Actient), a private urology specialty therapeutics company, for $585 million in upfront cash plus certain contingent consideration and warrants to purchase Auxilium common stock. Auxilium expects to receive a tax benefit, with a net present value of approximately $60 million, as a result of the acquisition of Actient. To finance the acquisition, Auxilium is using cash on hand and the proceeds from a new secured loan of $225 million from Morgan Stanley Senior Funding, Inc. Full Article
Auxilium Pharmaceuticals Inc Announces Positive Top-Line Data From XIAFLEX Frozen Shoulder Syndrome Phase IIa Study
Auxilium Pharmaceuticals Inc announced positive data for collagenase clostridium histolyticum or CCH which is being developed for the potential treatment, if approved by the U.S. Food and Drug Administration (FDA), of adult patients with adhesive capsulitis (AC), commonly known as Frozen Shoulder syndrome (FSS). FSS is a common, prolonged, painful condition of the shoulder in which increased capsular collagen thickening and subsequent capsular contraction in the shoulder joint is thought to cause a loss of range of motion in the shoulder. The condition is believed to affect approximately two to 5% of the general adult population and the full duration of the disease can last from approximately 1 year to up to 3.5 years.1 The majority of cases are curr ently managed conservatively with prolonged physical therapy and occasionally with steroid injections. It is estimated that approximately 300,000 cases of FSS are diagnosed annually and approximately 10% are treated with an invasive intervention (surgery or manipulation under anesthesia) on an annual basis. The phase IIa study was an open-label, controlled dose-ranging study designed to assess the safety and efficacy of CCH for the treatment of Stage 2 unilateral idiopathic FSS in comparison to an exercise-only control group. Full Article
Auxilium Pharmaceuticals Inc Reaffirms FY 2013 Guidance-Conference Call
Auxilium Pharmaceuticals Inc announced that for fiscal 2013, it expects total revenues of $325 million to $355 million with Testim revenues of $250 million to $265 million, US XIAFLEX revenues of $65 million to $75 million and non-GAAP basis income to be $18 million to $23 million. According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $336 million for fiscal 2013. Full Article
Auxilium Pharmaceuticals Inc Issues FY 2013 Guidance; Net Income Guidance Above Analysts' Estimates
Auxilium Pharmaceuticals Inc announced that for fiscal 2013, it expects global net revenues to be in the range of $325 to $355 million and Net income on a non-GAAP basis to be in the range of $18 to $23 million. According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $342 million and net income of $2.21 million for fiscal 2013. Full Article
Auxilium Pharmaceuticals Inc Announces Issuance Of $350 Million Of 1.50% Convertible Senior Notes Due 2018
Auxilium Pharmaceuticals Inc announced the closing of its previously announced offering of 1.50% Convertible Senior Notes due 2018. Auxilium issued $350.0 million aggregate principal amount of Convertible Notes, which included $25.0 million aggregate principal amount of Convertible Notes issued pursuant to the exercise in full by the underwriters of their option to purchase additional Convertible Notes, in an offering registered under the Securities Act of 1933, as amended. The net proceeds from the Offering were approximately $338.7 million after deducting underwriters' discounts and commissions and estimated offering expenses. Auxilium used approximately $28.5 million of the net proceeds from the Offering to pay the cost of the note hedge transactions described below (after such cost was partially offset by the proceeds from the sale of the warrants, as described below) and intends to use the remainder of the net proceeds from the Offering for general corporate purposes, which may include the acquisition (including by merger, purchase, license or otherwise) of businesses, products, product rights or technologies. Goldman, Sachs & Co. and J.P. Morgan Securities LLC acted as joint book-running managers for the Offering. Cowen and Company and RBC Capital Markets acted as co-managers for the Offering. Full Article
Auxilium Pharmaceuticals Inc and Xstelos Holdings Inc File Lawsuit Against Upsher-Smith Laboratories, Inc. for Infringement of Testim Patents
Auxilium Pharmaceuticals and Xstelos Holdings Inc announced that they filed a lawsuit against Upsher-Smith Laboratories, Inc. ("USL") for infringement of ten U.S. patents covering Testim, 1% testosterone gel, that are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration (FDA). These ten patents are owned by FCB I LLC, an indirect majority owned subsidiary of Xstelos, and are exclusively licensed to Auxilium. Xstelos holds the assets of CPEX Pharmaceuticals, Inc., the predecessor owner of the patents. The lawsuit was filed in the United States District Court for the District of Delaware on January 28, 2013.Auxilium and Xstelos filed this lawsuit in response to a notice letter sent by USL regarding its filing with the FDA of New Drug Application ("NDA") No. 204399 for a 1% testosterone gel product. This letter also stated that NDA No. 204399 contained Paragraph IV certifications, under 21 U.S.C. Section 314.52(c) of the Federal Food, Drug, and Cosmetic Act, with respect to the ten patents listed in the Orange Book as covering Testim: U.S. Patent Nos. 7,320,968; 7,608,605; 7,608,606; 7,608,607; 7,608,608; 7,608,609; 7,608,610; 7,935,690; 8,063,029; and 8,178,518. These ten patents are expected to expire on various dates ranging from April 21, 2023 through January 18, 2025. Full Article
Auxilium Pharmaceuticals Inc Announces Pricing Of $325.0 Million Of 1.50% Convertible Senior Notes Due 2018
Auxilium Pharmaceuticals Inc announced the pricing of $325.0 million aggregate principal amount of 1.50% Convertible Senior Notes due 2018 (the Convertible Notes), in an offering (the Offering). Settlement is scheduled to occur on January 30, 2013. Auxilium has also granted the underwriters of the Convertible Notes a 30-day option to purchase up to an additional $25.0 million aggregate principal amount of the Convertible Notes. The Convertible Notes will pay interest semi-annually at a rate of 1.50% per annum and have been priced at par. The Convertible Notes are convertible, at the holder's option at an initial conversion rate of 41.3770 shares of Auxilium's common stock per $1,000 principal amount of Convertible Notes. The Convertible Notes will be general senior unsecured obligations of Auxilium. Auxilium estimates that the net proceeds from the Offering will be approximately $314.5 million (or approx $338.7 million if the underwriters' option is exercised in full) after deducting underwriters' discounts and commissions and estimated offering expenses. Auxilium intends to use the net proceeds from the Offering to pay the cost of the note hedge transactions and for general corporate purposes, which may include the acquisition (including by merger, purchase, license or otherwise) of businesses, products, product rights or technologies. Full Article
Auxilium cuts sales outlook, expands urology business
- Auxilium Pharmaceuticals Inc reported a big drop in quarterly sales in the United States for both of its drugs, and said it acquired Actient Holdings LLC to bolster its urology business.

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