Key Developments For American Medical Systems Holdings, Inc.
American Medical Systems Holdings, Inc. (AMMD.O) (Nasdaq)
American Medical Systems Issues Q4 2009 Guidance in Line With Analysts' Estimates; Raises FY 2009 Guidance
American Medical Systems announced that it expects fourth quarter 2009 revenue in the range of $136 to $142 million, resulting in fiscal 2009 revenue guidance of $509 to $515 million an increase from previous fiscal 2009 revenue guidance of $495 to $510 million. The Company estimates fourth quarter 2009 non-GAAP adjusted earnings per share (EPS) in the range of $0.29 to $0.33 and fiscal 2009 non-GAAP adjusted EPS in the range of $1.10 to $1.14. This is an increase from previous guidance for the fiscal 2009 in the range of $1.00 to $1.10. This guidance excludes the impact of amortization of intangible assets which is approximately $0.03 and $0.11 for the fourth quarter and fiscal 2009, respectively, and amortization of financing costs which is approximately $0.04 and $0.14 for the fourth quarter and fiscal 2009, respectively. According to Reuters Estimates, analysts were expecting the Company to report revenue of $137 million and EPS of $0.32 for the fourth quarter 2009; revenue of $504 million and EPS of $1.06 for fiscal 2009.
American Medical Systems's AMS800 Artificial Urinary Sphincter Approved For Use In Japan
American Medical Systems announced that it has received clearance from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market and distribute its AMS 800 Artificial Urinary Sphincter (AUS) in Japan, effective September 7, 2009.
Conceptus Acquires Ovion Patents from American Medical Systems
Conceptus announced that it has acquired Ovion intellectual property rights from American Medical Systems Holdings, Inc. (AMS) for a cash purchase price of $23.6 million. The intellectual property rights acquired in the transaction include all patents and intellectual property associated with the Ovion business acquired by AMS in 2005. In addition, AMS has released Conceptus from any future royalty obligations under the 2003 Settlement Agreement between Ovion and Conceptus. Under the 2003 Settlement Agreement, Conceptus had been making royalty payments to AMS equal to 3.25% of the Company`s Essure sales. Following this acquisition, the Company will no longer owe these royalty payments. Commencing with the fourth quarter of 2009, Conceptus will amortize the cost of the intangible assets acquired over the remaining life of the patents, which is approximately eight years. The amortization of intangible assets is expected to be less than the previous royalty payments, making this transaction accretive for Conceptus. The Company anticipates recording a benefit of $0.05 per fully diluted share in the third quarter of 2009 as a result of the acquisition due to the release of the Company`s royalty obligations under the 2003 Settlement Agreement.
New Clinical Data Shows American Medical Systems's Minimally Invasive Treatment Options Effective at Restoring Female Pelvic Health
American Medical Systems announced the results of three major clinical studies that each point to a high degree of efficacy and patient satisfaction with the Company's minimally invasive treatment options for female stress urinary incontinence (SUI) and vaginal prolapse. Alongside these positive outcomes, the studies also revealed that each treatment resulted in minimal post-operative pain for patients and a low incidence of adverse events. In a 6-month prospective evaluation of the Company's MiniArc Single-Incision Sling System for surgical treatment of female SUI, the device was found to provide a 91% success rate at six months post-op using an objective measure of negative cough stress test (CST) among patients with a positive baseline CST. The study derived at 16 treatment centers in North America and Europe concluded that MiniArc results in minimal estimated blood loss, minimal length of hospital stay and involves short operative times. The most common complications were reported in less than 2% of patients with no reports of bowel, urethral, bladder or major vessel perforations. In the single-arm, prospective, multi-center trial encompassing 139 patients with Stage II or greater prolapse at 16 U.S. and European sites, the Elevate Apical and Posterior total transvaginal prolapse repair system demonstrated efficacy rates of 94.5% in posterior treatment and 95.1% in apical treatment, with minimal mesh extrusion rate of 5.8% at 6 months.
American Medical Systems Wins NHS Contract To Supply Women's Incontinence Treatment Devices In UK
American Medical Systems announced that it has been included as part of a multiple awardees contract by National Healthcare Services (NHS) Supply Chain (NHSSC) to supply three of its female stress urinary incontinence (SUI) treatment devices through the Normanton distribution centre, United Kingdom. The contract makes the Company' Monarc Subfascial Hammock, MiniArc Single Incision Sling, and SPARC Sling System available to women treated in any NHS hospital in the region through NHS (the public healthcare provider) serviced and supported by the Normanton centre.
