Advanced Medical Optics Provides Updated Financial Guidance for 2007 and 2008.Reflects Estimated Impact of May 2007 Recall and Plans to Re-Enter re·en·ter also re-en·ter v. re·en·tered, re·en·ter·ing, re·en·ters v.tr. 1. To enter or come in to again. 2. To record again on a list or ledger. v.intr. the Multipurpose Market End of Third Quarter 2007 SANTA ANA, Calif. -- Advanced Medical Optics Advanced Medical Optics, Inc., (NYSE: EYE) (known as AMO) is a global medical device leader focused on the discovery and delivery of innovative vision technologies that optimize the quality of life for people of all ages. , Inc. (AMO AMO - America's Multimedia Online ) (NYSE NYSE See: New York Stock Exchange :EYE), a global leader in ophthalmic surgical devices and eye care products, today announced financial guidance for 2007 and 2008 that reflects the estimated impact of the company's May 2007 global recall of its MoisturePlus(TM) multipurpose solution. For 2007, the company expects sales in the range of $1,050 million to $1,070 million and an adjusted loss per share in the range of $0.95 to $1.15. The company's adjusted per-share guidance excludes the impact of charges and write-offs associated with acquisitions, recapitalizations and unrealized gains or losses on derivative instruments Derivative instruments Contracts such as options and futures whose price is derived from the price of an underlying financial asset. and other one-time charges. Previous 2007 guidance was $1,150 million to $1,175 million in sales and $1.40 to $1.55 in adjusted EPS (Encapsulated PostScript) A PostScript file format used to transfer a graphic image between applications and platforms. EPS files contain PostScript code as well as an optional preview image in TIFF, WMF, PICT or EPSI, the latter being an ASCII-only format. . The revised guidance includes: * An estimated reduction of approximately $100 million to $120 million in net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight . * Estimated costs to conduct the recall and introduce a different branded multipurpose solution in late 2007. * Higher expected incremental interest expense because the company does not expect to reduce its debt levels as quickly as previously forecast. * Adverse tax impacts created by the shift in the geographic mix of sales and income as a result of the removal of MoisturePlus(TM) from the market. Based on its expectation for 2007, the company's guidance for 2008 sales is a range of $1,230 million to $1,250 million, and a range of $1.55 to $1.75 for 2008 adjusted earnings per share. Previous 2008 guidance was $1,350 million to $1,370 million in sales, and $2.25 to $2.40 adjusted EPS. "Since initiating the recall one month ago, we have been fully focused on addressing the needs of patients, eye care professionals and customers while working closely with regulatory agencies around the world to ensure a swift, thorough and coordinated effort," said Jim Mazzo, AMO chairman, president and chief executive officer. "While the near-term financial implications of the recall are significant, I am confident that we have taken the appropriate steps and are now well positioned to turn our attention to re-entering the multipurpose market before the end of the year." Plan to Re-Enter the Multipurpose Market AMO is planning to launch a multipurpose product using an existing proprietary formulation approved by various regulatory agencies across the globe, including the Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). The company expects the solution to be marketed and sold globally under the company's flagship Complete[R] brand name and to reinforce a rub-and-rinse regimen for effective contact lens contact lens, thin plastic lens worn between the eye and eyelid that may be used instead of eyeglasses. Actors, models, and others wear them for appearance, and athletes use them for safety and convenience. disinfection disinfection, n the process of destroying pathogenic organisms or rendering them inert. disinfection, full oral cavity, n a procedure used to reduce active periodontal disease, usually completed within a certain short time frame. and comfort. AMO has stepped up production at both of its eye care manufacturing facilities and anticipates having the Complete[R] multipurpose solution on retail shelves by the end of the third quarter. This Complete[R] multipurpose solution will complement AMO's other existing eye care products, including its rewetting drops and hydrogen peroxide hydrogen peroxide, chemical compound, H2O2, a colorless, syrupy liquid that is a strong oxidizing agent and, in water solution, a weak acid. It is miscible with cold water and is soluble in alcohol and ether. systems. Many optometric and ophthalmic professional organizations around the world include a rub-and-rinse step in their contact lens handling guidelines. For example, in a recent news release, the American Optometric Association The American Optometric Association (AOA) represents optometrists nationally in the USA. It consists of State Optometric Associations, which are made up of local Optometric Societies. , which represents more than 34,000 doctors of optometry optometry (ŏptŏm`ətrē), eye-care specialty concerned with eye examination, determination of visual abilities, diagnosis of eye diseases and conditions, and the prescription of lenses and other corrective measures. , optometry students and paraoptometric assistants and technicians, stated that "most solutions are approved for use without rubbing; however, optometrists are recommending at this time that patients rub their lenses to enhance cleaning for additional safety." Recall Background AMO initiated a global recall of its MoisturePlus(TM) multipurpose solution on May 25, 2007, after the U.S. Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. (CDC See Control Data, century date change and Back Orifice. CDC - Control Data Corporation ) identified through the preliminary results of a study a potential link between the product and Acanthamoeba Acanthamoeba /Acan·tha·moe·ba/ (ah-kan?thah-me´bah) a genus of free-living ameboid protozoa (order Amoebida) found usually in fresh water or moist soil. Certain species, such as A. astronyxis, A. castellanii, A. culbertsoni, A. keratitis keratitis Inflammation of the cornea (see eye). The conjunctiva may also be inflamed (keratoconjunctivitis). Depending on the cause, including dryness of the eye (from low tear production or inability to close the eye), chemical or physical injury, or certain (AK), a rare but serious infection of the cornea cornea: see eye. caused by a naturally occurring water-borne organism. AMO immediately halted product shipments, recalled product from the marketplace and encouraged consumers to discontinue use through news announcements, Internet postings, notifications to eye care practitioners and their professional organizations and other means. The company continues to work closely with the CDC and FDA to assess the data the agencies are collecting. Live Web Cast & Audio Replay AMO will host a conference call at 8:30 a.m. EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT today to discuss this press release with analysts and investors. To listen, visit www.amo-inc.com. An audio replay will also be available at approximately noon EDT today, continuing through midnight EDT on Friday, June 29, 2007, at 800-642-1687 (conference ID# 4755611). About Advanced Medical Optics (AMO) AMO develops advanced, life-improving vision technologies for people of all ages. Products in the cataract/implant line include intraocular lenses (IOLs), phacoemulsification phacoemulsification /phaco·emul·si·fi·ca·tion/ (-e-mul?si-fi-ka´shun) a method of cataract extraction in which the lens is fragmented by ultrasonic vibrations and simultaneously irrigated and aspirated. systems, viscoelastics, and related products used in ocular surgery. AMO owns or has the rights to such product brands as ReZoom([R]), Tecnis([R]), Clariflex([R]), Sensar([R]), and Verisyse([R]) IOLs, Sovereign([R]), Sovereign([R]) Compact and WhiteStar Signature([TM]) phacoemulsification systems with WhiteStar([R]) technology, Healon([R]) viscoelastics, and the Baerveldt([R])glaucoma shunt. Products in the laser vision correction line include wavefront Noun 1. wavefront - (physics) an imaginary surface joining all points in space that are reached at the same instant by a wave propagating through a medium wave front diagnostic devices, femtosecond lasers and associated patient interface devices, and excimer laser vision correction systems and treatment cards. AMO brands in the laser vision correction business include Star S4 IR([R]), WaveScan Wavefront([R]), CustomVue([R]), IntraLase([R]) FS, IntraLase Method([TM]) and IntraLasik([R]). Products in the contact lens care line include disinfecting solutions, enzymatic cleaners and lens rewetting drops. Among the eye care product brands the company possesses are COMPLETE([R]), COMPLETE([R]) Blink-N-Clean([R]), Consept([R])F, Consept([R]) 1 Step, Oxysept([R]) 1 Step, UltraCare([R]), Ultrazyme([R]), Total Care([TM]) and blink[TM]branded products. AMO is based in Santa Ana, California Santa Ana is the most populous city in Orange County, California and is the county seat. It lies approximately 10 miles inland from the Pacific Ocean, on the largely seasonal Santa Ana River. , and employs approximately 4,200 worldwide. The company has operations in 24 countries and markets products in approximately 60 countries. For more information, visit the company's Website at www.amo-inc.com. Use of Non-GAAP Measures Our per-share guidance for 2007 and 2008 is provided on a non-GAAP basis. The company's adjusted EPS guidance excludes any charges associated with acquisitions, reorganizations and recapitalizations and other one-time charges. The guidance also assumes no impact of potential unrealized gains or losses on derivative instruments. The company believes this presentation is useful to investors to conduct a more meaningful, consistent comparison of the company's ongoing operating results. This presentation is also consistent with our internal use of the measure and prior guidance structure, which we use to measure the profitability of ongoing operating results against prior periods and against our internally developed targets. We believe that our investors also use this measure to analyze the sustainable profitability of the on-going business operations. The economic substance related to our use of adjusted per-share guidance is our belief that the appropriate analysis of our profitability cannot be effectively considered while incorporating the effect of unusual items and charges that have not been experienced in prior periods. The company is not able to provide a reconciliation of projected adjusted per-share guidance to expected reported results due to the unknown effect, timing and potential significance of special charges, and our inability to forecast charges associated with future transactions and initiatives. These non-GAAP financial measures are used in addition to and in conjunction with results presented in accordance with GAAP GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (GAAP). . These non-GAAP financial measures reflect an additional way of viewing aspects of our operations that, when viewed with our GAAP results, provide a more complete understanding of factors and trends affecting our business. These non-GAAP measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with 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 . Forward-Looking Statements This press release contains forecasts about AMO and its businesses, such as management's total revenue and adjusted per-share outlook. Because forecasts are inherently estimates that cannot be made with precision, the company's performance may at times differ from its estimates and targets. Statements in this press release regarding financial guidance, statements of Mr. Mazzo, statements regarding plans to re-enter the multipurpose segment, and any other statements in this press release that refer to AMO's estimated or anticipated future results, are forward-looking statements. All forward-looking statements in this press release reflect AMO's current analysis of existing trends and information and represent AMO's judgment only as of the date of this press release. Actual results may differ from current expectations based on a number of factors affecting AMO's businesses including, but not limited to, uncertainties associated with successful and timely execution of our recalls, unexpected changes in competitive, regulatory and market conditions; the performance of new products and the continued acceptance of current products; the execution of strategic initiatives and alliances; AMO's ability to maintain a sufficient supply of products; consumer spending and confidence; product liability claims or new quality issues; litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. related to our recall or otherwise; and the uncertainties associated with intellectual property protection for the company's products. In addition, matters generally affecting the domestic and global economy, such as changes in interest and currency exchange rates or consumer confidence indices, can affect AMO's results. Therefore, the reader is cautioned not to rely on these forward-looking statements. AMO disclaims any intent or obligation to update these forward-looking statements. Additional information concerning these and other risk factors may be found in previous financial press releases issued by AMO. AMO's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in AMO's 2006 Form 10-K filed in March 2007 and Form 10-Q filed in May 2007 that include information concerning these and other risk factors. Copies of press releases and additional information about AMO are available at www.amo-inc.com, or by contacting AMO's Investor Relations Department by calling 714-247-8455. |
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