This excerpt taken from the EYE 8-K filed Feb 14, 2006.
Major 2005 Developments
During 2005, AMO achieved a number of important milestones, including:
Acquisition and integration of VISX, Incorporated, the global leader in laser vision correction (LVC); FDA approval and launch of three LVC technologies: CustomVue® LASIK for high myopia, CustomVue® LASIK for mixed astigmatism and Iris Registration, a proprietary iris tracking technology. With these approvals, AMO has the widest range of wavefront-guided LASIK indications in the U.S.
FDA approval and U.S. launch of ReZoomTM, a multifocal intraocular lens (IOL) providing a full range of near, intermediate and distance vision. The ReZoomTM lens also qualified as a presbyopia-correcting lens under a 2005 Centers for Medicare and Medicaid Services (CMS) ruling, allowing Medicare cataract patients to pay an additional fee for the lens.
FDA approval and launch of the Tecnis® Acrylic lens, a wavefront-designed monofocal IOL that reduces spherical aberration and carries a unique FDA claim for improved functional vision. In early 2006, the Tecnis® lens was also granted New Technology Intraocular Lens (NTIOL) status by CMS, recognizing the unique clinical benefits of this new technology and providing ambulatory surgical centers an additional $50 Medicare reimbursement per lens. It is the only IOL with NTIOL designation.
Expiration of a non-competition agreement with its former parent, allowing AMO to initiate development of an over-the-counter dry eye product, estimated to launch in the U.S. in 2007.
Establishment of the companys global eye care manufacturing capability in advance of the June 2005 expiration of a three-year manufacturing agreement with its former parent.
Acquisition of Quest Vision, providing AMO novel accommodating IOL designs and expanding its R&D pipeline of refractive technologies.
Favorable jury verdict followed by a judgment in January 2006 for approximately $234 million being entered against Alcon, Inc. for infringement of AMO patents regarding key phacoemulsification technology. The parties are appealing the judgment, and Alcon is seeking a new trial.
Establishment of a direct sales model in India and termination of a distributor agreement with its former parent in that country.
Capital structure improvement and interest rate reduction through issuance of $150 million in 1.375 percent convertible senior subordinated notes and retirement of the remainder of the companys 3.5 percent convertible senior subordinated notes.
During the fourth quarter of 2005, AMO announced the acceleration of a broad rationalization and repositioning strategy initiated in 2004. Under the plan, AMO is eliminating numerous non-core eye care and cataract products while increasing its emphasis on advanced, higher-growth technologies and implementing planned productivity initiatives. Moving more aggressively to implement the rationalization and repositioning allows AMO to focus on four key growth opportunities:
Expanding its fee-based LVC business in select international markets,
Capitalizing on its diverse refractive IOL offering, including ReZoomTM, Tecnis® Multifocal and VerisyseTM lenses, at a time when surgeon demand for its technologies is increasing and the market is undergoing rapid growth, primarily in the U.S.,
Increasing global penetration of its core, technology-backed brands, including Tecnis®, Healon®, White StarTM, CustomVueTM, COMPLETE® and blinkTM, and
Leveraging its eye care competencies and global franchise to enter the dry eye market.
Additional information is provided under the heading Rationalization & Repositioning Strategy.