Beruflich Dokumente
Kultur Dokumente
(Nasdaq: STAA)
David Bailey, President & CEO Deborah Andrews, CFO May 2007
FORWARDFORWARD-LOOKING STATEMENTS
All statements in this presentation that are not statements of historical fact are forwardforward-looking statements, including any projections of earnings, revenue, cash or other financial items, any statements of the plans, strategies, and objectives of management for future operations, any statements regarding expectations for success of the ICL or other products in U.S. or international markets, any statements concerning proposed new products and government approval of new products, services or developments, any statements regarding future economic conditions or performance, statements of belief and any statements of assumptions underlying any of the foregoing. These statements are based on expectations and assumptions as of the date of this presentation and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. forwardThe risks and uncertainties include our limited capital resources and limited access to financing, our ability to overcome negative publicity resulting from warning letters and other correspondence from the FDA Office of Compliance, the willingness of surgeons and patients to adopt a new product and procedure, and our ability to successfully launch and market the ICL in the U.S. while overcoming the foregoing challenges, our ability to implement our cost savings strategies and realize our expected savings, our ability to reverse the decline in domestic sales of intraocular lenses, our ability to maintain or enhance our existing product sales and gross profit margin and reduce compliance expenditures, the rapid pace of technological change in the ophthalmic industry, our ability to compete with much larger ophthalmic companies, general domestic and international economic conditions, and other factors beyond our control, including those discussed under the heading Risk Factors Factors in our Current Report on Form 8-K filed with the SEC on April 26, 2007 and our 8Annual Report on Form 10K for fiscal year 2006. STAAR assumes no obligation to update these forward-looking statements to reflect future events or actual outcomes and does not forwardintend to do so.
Investment Considerations
Large and growing addressable market Cataract and Refractive Proprietary Collamer technology Leadership in phakic implants; Visian ICL Opportunity to rebuild Share in the Cataract market
Company Background
Founded in 1982
Original core technology was foldable IOLs, which are now the gold standard in ophthalmology 1990s: Development of major new technologies: Collamer material and ICL 2000s: New management, ICL/TICL commercialization, Preloaded introduction
2005
$5.4
10.4% 31.5%
2004
$4.1
7.8% 37.6%
$12.7
22.3% 136.1%
Cataract Revenue
% of Revenue % Change YoY
$44.3
77.7% (4.7%)
$46.5
89.6% (3.5%)
$48.2
92.2% .3%
Total Revenue
% Change YoY
$57.0
9.8%
$51.9
(.8%)
$52.3
2.5%
Addressable Markets
Refractive Error (Myopia, Astigmatism, Hyperopia). Elective Cataracts: Opacification of the lens of the eye. Age related. Reimbursed
Visian
ICL
Refractive Keratotomy (RK) becomes widespread in 1980s, then declines First laser procedure, Photo Refractive Keratectomy (PRK) becomes widespread in mid-1990s, then declines midSecond laser procedure, Laser In-Situ Keratomileusis In(LASIK) becomes widespread in late 1990s. 2000 - Heavy Investments in LASIK marketing and technology growth stagnates, Low penetration rates 2000 - Phakic Implants, Multifocal/Accommodating implants, Toric Implants Refractive Surgery is going inside the eye
Up to 1.5 billion myopes worldwide; geographic variances in key matrices e.g. mean myopia 3.0 million LASIK procedures/year WW
Recent cannibalization in the US to PRK 10 to 15%. Driven by large law suits over some corneacorneabased procedures
Target at -7.5D and above - adjusted population in the US of six million eyes per year. (same in -6 to -7 group) Targeted penetration rate of this market is 10% over time 600,000 procedures In International equate to 100 million eyes per year Support for superiority of phakic implants
Cornea, Cornea, Dec. 2006 ICL safer & more effective than LASIK for -4D to -7.88D ASCRS Presentation Apr. 2007 Phakic IOLs procedure of choice to correct myopia at -6.5D+, Dr. Neatrour
Refractive Revenue
Cataract Revenue
Gross Margin
Visian Advantages
Architecture and Anatomy of the Cornea is completely unchanged with the ICL. Correct the Vision NOT the eye Ease of use for the Surgeon existing skill set Patient friendly topical anesthesia, small incision, quick rehabilitation, wow for patient. Exceptional clinical outcomes Navy driving study, ASCRS April 2007 Additive Vs Subtractive Removable Manageable complication profile - With a LASIK complication an effective solution is not always easily available
Training/Certification
Practice Integration
Establishing a cut-off for patient selection cut Integrating the cut-off in the whole network cut
Practice Building
Profitable procedure
Few re-treats re Happy patients = free marketing = positive referrals Mitigated risk
to Market Scope, PRK represented 13% of laser-based refractive procedures in 2006, laserup from 8% in 2005
PRK resurgence driven by fear of ectasia and the perception that PRK is safer than LASIK
The
The Slade contra-lateral study at 2006 ESCRS indicated contrasignificantly higher pain and lower visual acuity
PRK patients will not yield positive referrals If surgeons are uncomfortable with cornea-based corneaprocedures, they should not do LASIK or PRK
Therefore, the Visian ICL is the answer for the 1% to 15% of US volume that is now PRK (140k to 200k eyes)
Worldwide IOL market, estimated 13.8M procedures ($1.28 billion) performed in 05 Market growing to $2.42 billion by 2010 (17.1M procedures), representing a CAGR of 13.5% by 2010 Driven by innovation / improved outcomes
Largest IOL market, estimated 2.9M procedures ($428 million) performed in 05 Market growing to $1.034 billion by 2010 (3.2M procedures), representing a CAGR of 19% by 2010 Medicare reimbursement is DECREASING doctors and looking to upsell the patient Presbyopic IOLs (accommodating and multifocal) and RLE will grow but slower than recently projected Toric IOLs will lead the upsell following CMS
STAAR Toric IOL qualifies for dual aspect reimbursement under new CMS ruling Collamer Aspheric IOL launched at ASCRS, April 2007 Silicone Aspheric IOL Q307 Introduction Preloaded Silicone Aspheric Injector 1H2008
Players - Now
Material
Silicone Acrylic Other
STAAR Alcon STAAR
Alcon AMO AMO Bausch & Lomb STAAR * Alcon AMO Alcon STAAR Eyeonics Alcon AMO Alcon STAAR *
Current US Cataract
Opportunity to build share currently >4% Four players; ACL, AMO, B+L, STAAR Revamping the offering 2007 early 08 Strengthening sales effort
direct RMRs direct sales people to supplement agents Heavy commission bias to new products
Gross Profit Margin of 48.9% and growing Effective expense management 12% improvement in cash usage Buffered cash position to fund growth strategy
Cash as of March 30, 2007 - $9.2 million $16.9 million raised May 1
German subsidiary stabilized and growing Intl. Refractive CAGR of 35% since 2004 ICL adoption rate continues to grow New product approvals pending
Q1 06
Q2 06
Q3 06
Q4 06
Q1 07
Cataract
Refractive
Percent
Long-Term Operating Model LongSales - cataract Sales - refractive Total sales* COS - cataract COS - refractive Total COS GP cataract GP - refractive GP - total G&A M&S R&D Total SG&A & R&D Operating Income Other Income before taxes Income taxes** Net income 60% 40% 100% 40% 15% 30% 60% 85% 70% 9% 28% 8% 45% 25% 1% 26% 1% 24% $ 60,000,000 $ 40,000,000 $100,000,000* $ 24,000,000 $ 6,000,000 $ 30,000,000 $ 36,000,000 $ 34,000,000 $ 70,000,000 $ 9,000,000 $ 28,000,000 $ 8,000,000 $ 45,000,000 $ 25,000,000 $ 500,000 $ 25,500,000 $ 1,300,000 $ 24,200,000
* $100,000,000 is a hypothetical number for demonstration purposes only and is not meant to indicate actual sales or projected sales in any period. **Assumes no U.S. income taxes paid until NOLs absorbed at approximately $80 million earnings.
Investment Considerations
Large and growing addressable market Cataract and Refractive Proprietary Collamer technology Leadership in phakic implants; Visian ICL Opportunity to rebuild Share in the Cataract market