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Advanced Medical Opt : Advanced Medical Optics Announces Second-Quarter 2007 Results

02/08/2007 | 14:00

Advanced Medical Optics, Inc. (AMO) [NYSE:EYE], a global leader in ophthalmic surgical devices and eye care products, today announced financial results for the second quarter of 2007.

The company's second-quarter 2007 net sales rose 1.7 percent to $261.4 million. The sales increases related to the April 2007 acquisition of IntraLase Corp. and organic growth were offset by lost sales and product returns related to the May 2007 MoisturePlus recall. Foreign currency impacts increased net sales by 1.7 percent.

AMO reported a second-quarter net loss under Generally Accepted Accounting Principles (GAAP) of $166.8 million, or a loss of $2.78 per share, which included the impact of the recall. These results also included the following items, which combined to increase the net loss per share by approximately $1.98:

  • $85.4 million pre-tax, non-cash in-process research and development (R&D) charge and a $7.7 million pre-tax, non-cash inventory step-up to fair value charge related to the IntraLase acquisition.
  • Approximately $14.5 million in pre-tax transaction-related charges.
  • $1.2 million in a pre-tax, non-cash deferred financing cost write-off related to the IntraLase acquisition financing and a gain on derivative instruments.
  • $9.8 million unfavorable tax impact associated primarily with acquisition-related items.

In the same period last year, AMO reported a GAAP net loss of $2.7 million, or a loss of $0.04 per share. A total of $52.7 million in pre-tax items reduced second-quarter 2006 results by $0.54 per share. These items were related primarily to note repurchases, rationalization and repositioning initiatives and an unrealized loss on derivative instruments.

?In the second quarter, we moved aggressively to integrate IntraLase,? said Jim Mazzo, AMO chairman, president and chief executive officer. ?Our Advanced CustomVue® technology and IntraLase® FS laser drove laser vision correction sales to new highs, demonstrating the strategic value of this combination. In addition, our portfolio of refractive implants delivered double-digit growth on a sequential and year-over-year basis and helped fuel an 8 percent rise in intraocular lens sales. Furthermore, our eye care business moved quickly and responsibly to execute a global recall, and developed a comprehensive plan to re-enter the multipurpose contact lens care market ahead of schedule.?

Second-Quarter Performance by Product Line

Below are sales highlights of second-quarter 2007 results by product line. Growth rates reflect comparisons to the same period in 2006 and include the impacts of foreign currency. Pro forma growth rates reflect comparisons that include IntraLase's performance in the same period of 2006. For more information, see the table entitled ?Global Sales? that accompanies this release.

Cataract/Implant sales rose 4.3 percent to $140.2 million.

  • Total intraocular lens (IOL) sales rose 8.0 percent to $81.3 million.
  • Monofocal IOL sales rose 5.4 percent to $66.8 million, reflecting continued strong growth of the Tecnis® IOL franchise.
  • Refractive IOL sales grew 21.8 percent to $14.5 million, reflecting continued demand for the company's ReZoom®, Tecnis® Multifocal, VerisyseTM and VeriflexTM IOLs. Compared to the first-quarter of 2007, refractive IOL sales rose 12.6 percent, demonstrating continued market share gains.
  • AMO's Healon® family of viscoelastics grew 0.5 percent. Total viscoelastics sales of $32.3 million declined 1.6 percent.
  • Phacoemulsification sales declined 2.2 percent to $21.7 million, due primarily to anticipated lower equipment sales ahead of the commercial release of the new WhiteStar SignatureTM phacoemulsification system in the third quarter. Surgical pack sales rose 6.4 percent.

Laser Vision Correction (LVC) sales rose 91.2 percent to $102.1 million.

  • Pro forma LVC sales increased 17.0 percent.
  • Procedures and related sales of $63.6 million represented a 74.9 percent increase, or 25.6 percent on a pro forma basis.
  • AMO's U.S. LASIK procedure volumes grew 13.2 percent and its U.S. custom procedure mix reached 62.4 percent for the trailing 12 months ended June 29.
  • AMO's U.S. femtosecond procedure volumes grew 36.6 percent for the trailing 12 months ended June 29 on a pro forma basis.
  • International procedure sales were $16.1 million, which included excimer procedure sales of $5.2 million, up 61.4 percent, and femtosecond procedure sales of $10.9 million, up 98.1 percent on a pro forma basis.
  • System sales increased 190.5 percent to $28.5 million, or an increase of 6.4 percent on a pro forma basis. On a unit basis, placements of the VISX Star S4 IR® excimer laser rose 47 percent; IntraLase® FS laser placements rose 23 percent on a pro forma basis.

Eye Care sales declined 72.5 percent to $19.0 million.

  • AMO estimated that the recall reduced eye care sales by approximately $54 million, including approximately $31 million in returns and an estimated $23 million in lost sales. As a result of the sales returns, the company reported negative multipurpose sales of $7.8 million. The company incurred recall-related costs of approximately $27 million, which were recognized in cost of sales and SG&A expense.
  • Hydrogen peroxide sales declined 14.6 percent to $13.6 million, reflecting primarily the continued contraction of this market in Japan.

Product Update

AMO began shipments this week of a Complete®-branded multipurpose solution that it expects will be available to U.S. and European practitioners and patients in late August, marking the company's re-entry into the multipurpose market following the May recall. The company had originally expected to re-enter the market by the end of September. AMO will focus on disinfection efficacy and comfort, and promote a standard of care that emphasizes the importance of a rub-and-rinse regimen, per recommendations by professional eye care associations. AMO expects to begin shipments to other markets by the end of September.

In July, AMO received U.S. Food and Drug Administration (FDA) approval for the Advanced CustomVueTM Monovision procedure for the visual correction of myopic (nearsighted) presbyopic patients, with and without astigmatism. The approval marked an industry first as the Advanced CustomVueTM Monovision procedure is the only FDA-approved wavefront-guided LASIK treatment for the correction of both near and far vision in presbyopic patients. In a clinical trial, 96 percent of patients achieved 20/25 or better vision at both far and near after one year. AMO expects the procedure to be available to U.S. LASIK patients by the end of 2007.

In April, AMO introduced the White Star SignatureTM phacoemulsification system with FusionTM Fluidics. This new, advanced technology combines the proven performance of AMO's WhiteStar® technology with the safety of a revolutionary FusionTM dual pump fluidic system. A streamlined user interface and easy-to-use accessories enhance efficiency of the operating room environment. Commercial release of the WhiteStar SignatureTM system begins in August 2007.

Also in April, AMO received CE Mark for the commercial sale of its next-generation Tecnis® monofocal IOL in European Union member countries. It is designed to deliver ease-of-implantation with outstanding visual performance. AMO expects to launch this new IOL at the European Society of Cataract and Refractive Surgeons (ESCRS) meeting next month.

Additional Second-Quarter Highlights

Below are additional highlights of second-quarter 2007 results. Growth rates reflect comparisons to the same period one year ago.

  • Gross profit decreased 22.3 percent to $127.9 million, including a $7.7 million non-cash inventory step-up to fair value charge related to the IntraLase acquisition. Gross profit was also impacted by approximately $50.9 million in returns and costs and an estimated $15.9 million related to lost sales associated with the recall.
  • R&D expense rose 24.8 percent to $20.7 million, or approximately 7.9 percent of sales, compared to 6.4 percent in the second quarter of 2006. The increase was due primarily to the addition of IntraLase and WaveFront Sciences Inc.
  • SG&A expense rose 42.0 percent to $149.7 million, including approximately $14.5 million in transaction-related charges. SG&A expense was also impacted by the addition of IntraLase and WaveFront Sciences, and approximately $7.5 million in recall-related expenses.
  • Operating loss of $127.9 million included an $85.4 million non-cash in-process R&D charge related to the IntraLase acquisition and $22.2 million in transaction-related charges. The company estimated that the recall reduced operating income by approximately $72.2 million, including a $13.8 million impact of estimated lost sales. Second-quarter 2006 operating income of $25.0 million included $32.0 million in charges related primarily to rationalization and repositioning initiatives.
  • Non-operating expense declined 12.5 percent to $23.5 million. Interest expense rose to $22.0 million, due primarily to increased debt and a $1.3 million deferred financing cost write-off associated with the IntraLase acquisition. Second-quarter 2006 non-operating expense of $26.8 million included a $15.8 million charge for the early retirement of convertible senior subordinated notes. Interest expense in the year-ago quarter was $8.0 million and included a $2.4 million deferred financing cost write-off.
  • The company reported an income tax provision of $15.4 million, which included a $9.8 million unfavorable tax impact related primarily to acquisitions. The tax rate was also negatively affected by the non-deductible in-process R&D charge and the impact of the recall, including the related impact on utilization of foreign tax credits. AMO expects the recall to adversely affect its future tax liability and effective tax rate, and estimates its 2008 effective tax rate in the upper 30 percent range. The company also expects that the rate will decline to the low 30 percent range by 2010.

Six-Month Financial Results

Net sales for the first six months of 2007 rose 3.6 percent to $513.1 million, including a 2.1 percent increase related to foreign currency fluctuations. The rise reflects the addition of the IntraLase and WaveFront Sciences acquisitions and organic growth, which were largely offset by estimated recall-related lost sales and returns.

The company reported a GAAP net loss for the first six months of 2007 of $154.7 million, or a loss of $2.59 per share. The per-share loss was increased by $2.02 due to an $87.0 million charge for in-process R&D, approximately $22.2 million in transaction-related charges, a $1.3 million deferred financing cost write-off, a $300,000 loss on derivative instruments and a $9.7 million unfavorable tax impact associated primarily with acquisition-related items. For the first six months of 2006, the company reported a GAAP net loss of $0.1 million, or break even on a per share basis. Pre-tax net charges of $87.9 million reduced after-tax earnings per share by $0.87 and included $66.8 million in charges related primarily to rationalization and repositioning initiatives, $18.2 million related to note repurchases and a $2.9 million unrealized loss on derivative instruments.

Financial Guidance

AMO affirmed its guidance as follows:

 
2007 2008
 
Revenue (in millions) $1,050 - $1,070 $1,230 - $1,250
 
Adjusted Earnings (Loss) Per Share ($.95) - ($1.15) $1.55 - $1.75

The company's adjusted earnings (loss) per-share guidance includes the impact of the May 2007 recall and annualized acquisition-related amortization of approximately $70 million. The company's adjusted earnings (loss) per share guidance excludes any charges and write-offs associated with acquisitions, reorganizations, recapitalizations, as well as unrealized gains or losses on derivative instruments and other one-time charges.

Live Web Cast & Audio Replay

AMO will host a live Web cast to discuss this release today at 10:00 a.m. EDT. To participate and download slides that accompany the company's remarks, visit www.amo-inc.com. An audio replay will be available at approximately noon EDT today and will continue through midnight EDT on August 16 at 800-642-1687 (Passcode 7377311) or by visiting www.amo-inc.com.

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 systems, viscoelastics, and related products used in ocular surgery. AMO owns or has the rights to such product brands as ReZoom®, Tecnis®, Clariflex®, Sensar®, and Verisyse® IOLs, Sovereign®, Sovereign® Compact and WhiteStar Signature? phacoemulsification systems with WhiteStar® technology, Healon® viscoelastics, and the Baerveldt® glaucoma shunt. Products in the laser vision correction line include wavefront 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®, WaveScan Wavefront®, CustomVue®, IntraLase® FS, IntraLase Method? and IntraLasik®. 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®, COMPLETE® Blink-N-Clean®, Consept®F, Consept® 1 Step, Oxysept® 1 Step, UltraCare®, Ultrazyme®, Total Care? and blink? branded products. AMO is based in Santa Ana, California, 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 earnings (loss) 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. 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.

Forward-Looking Statements

This press release contains forecasts about AMO and its businesses, such as management's total revenue and adjusted earnings (loss) 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, sales trends, expected product launch and availability dates, expected recall impacts, 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 and unexpected supply delays, product liability claims or new quality issues; 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.

Advanced Medical Optics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
 
Three Months Ended Six Months Ended
(in thousands, except per share amounts)

June 29, 2007

 

 

June 30, 2006

 

June 29, 2007

 

 

June 30, 2006

 

Net sales:

Cataract/implant

$ 140,249 $ 134,421 $ 267,998 $ 254,865
Laser vision correction 102,110 53,401 166,725 114,356
Eye care   19,038       69,219     78,347       126,048  
261,397 257,041 513,070 495,269
 
Cost of sales (A)   133,486       92,373     227,653       179,208  
Gross profit 127,911 164,668 285,417 316,061
 
Selling, general and administrative 149,702 105,389 259,220 200,828
Research and development 20,680 16,565 39,844 33,538
In-process research and development 85,400 - 86,980 -
Business repositioning costs   -       17,720     -       46,974  
Operating income (loss)   (127,871 )     24,994     (100,627 )     34,721  
 
Non-operating expense (income):
Interest expense 22,040 8,028 28,204 12,535
Unrealized (gain) loss on derivative instruments (78 ) 2,464 305 2,902

Loss due to early retirement of convertible senior subordinated notes

- 15,798 - 15,798
Other, net   1,521       544     2,737       1,548  
23,483 26,834 31,246 32,783
           
Earning (loss) before income taxes (151,354 ) (1,840 ) (131,873 ) 1,938
 
Provision for income taxes 15,440 863 22,812 2,012
           
Net loss   ($166,794 )     ($2,703 )   ($154,685 )     ($74 )
 
Net earnings per share:
Basic ($2.78 ) ($0.04 ) ($2.59 ) ($0.00 )
Diluted ($2.78 ) ($0.04 )

© Business Wire 2007
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