300 likes | 475 Views
STAAR Surgical (Nasdaq: STAA). David Bailey, President & CEO Deborah Andrews, CFO May 2007. FORWARD-LOOKING STATEMENTS
E N D
STAAR Surgical (Nasdaq: STAA) David Bailey, President & CEO Deborah Andrews, CFO May 2007
FORWARD-LOOKING STATEMENTS All statements in this presentation that are not statements of historical fact are forward-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. The 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” in our Current Report on Form 8-K filed with the SEC on April 26, 2007 and our Annual 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 intend 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 • CMS ruling a positive • New product launches • Strong International growth • Turnaround and growth strategy underway
Company Background • Founded in 1982 • (STAAR = Surgical Technology And Applied Research) • 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
Addressable Markets • Refractive Error (Myopia, Astigmatism, Hyperopia). Elective • Cataracts: Opacification of the lens of the eye. Age related. Reimbursed
History of Refractive Surgery • Refractive Keratotomy (RK) becomes widespread in 1980s, then declines • First laser procedure, Photo Refractive Keratectomy (PRK) becomes widespread in mid-1990s, then declines • Second laser procedure, Laser In-Situ Keratomileusis (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
Vision Correction Market • Up to 1.5 billion myopes worldwide; geographic variances in key matrices e.g. mean myopia • 3.0 million LASIK procedures/year WW • 1.4 million US • 0.8 million China • 0.8 million ROW • Recent cannibalization in the US to PRK – 10 to 15%. Driven by large law suits over some cornea-based procedures
ICL Market – “Limits of LASIK” • 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, 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
Change in Product Mix and Effect on Gross Margin *exclusive of obsolecence charge of 5.3%
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
Sales & Marketing Strategy Three-pronged strategy • Training/Certification • Focused on the surgeon and patient outcomes • Practice Integration • Establishing a “cut-off” for patient selection • Integrating the cut-off in the whole network • Practice Building • Marketing the procedure to drive volume
Advantages for the Surgeon • ICL integration will build overall refractive volumes • Exceeds patient expectations • Profitable procedure • Few re-treats • Happy patients = free marketing = positive referrals • Mitigated risk • ICL diversifies the practice • LASIK technology is generic procedure • Future growth driven by new technologies ex LASIK
PRK – Not A Practice Builder • Concerns about LASIK have led to resurgence of PRK • According to Market Scope, PRK represented 13% of laser-based refractive procedures in 2006, up from 8% in 2005 • PRK resurgence driven by fear of ectasia and the perception that PRK is safer than LASIK • The perception of safety has been strongly challenged if not repudiated
PRK – Not A Practice Builder • PRK is very poor in early results and in patient satisfaction • The Slade contra-lateral study at 2006 ESCRS indicated significantly higher pain and lower visual acuity • PRK patients will not yield positive referrals • If surgeons are uncomfortable with cornea-based procedures, 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 Cataract Market “Large and Growing” • 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
US Cataract Market “Large and Growing” • 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 IOL’s will lead the “upsell” following CMS
New CataractProduct Introductions • 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 * Enhancements
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 RMR’s • direct sales people to supplement agents • Heavy commission bias to new products
Q107 Financial Recap • 11% year-over-year sales growth to $14.9 million • Refractive product sales up 47.5% • Cataract product sales up 2.4% • 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
Strong International Franchise • Products for sale in more than 40 countries • Direct sales in the US, Germany, Australia • Distributor sales in ROW • German subsidiary stabilized and growing • Int’l. Refractive CAGR of 35% since 2004 • ICL adoption rate continues to grow • New product approvals pending
Revenue Change Year over Year In Thousands
2005 Sales and Gross Profit Refractive Revenue as Percent of Total Refractive Gross Profit as Percent of Total
2006 Sales and Gross Profit Refractive Revenue as Percent of Total Refractive Gross Profit as Percent of Total
Long-Term Operating Model Sales - cataract 60% $ 60,000,000 Sales - refractive 40% $ 40,000,000 Total sales* 100% $100,000,000* COS - cataract 40% $ 24,000,000 COS - refractive 15% $ 6,000,000 Total COS 30% $ 30,000,000 GP – cataract 60% $ 36,000,000 GP - refractive 85% $ 34,000,000 GP - total 70% $ 70,000,000 G&A 9% $ 9,000,000 M&S 28% $ 28,000,000 R&D 8% $ 8,000,000 Total SG&A & R&D 45% $ 45,000,000 Operating Income 25% $ 25,000,000 Other 1% $ 500,000 Income before taxes 26% $ 25,500,000 Income taxes** 1% $ 1,300,000 Net income 24% $ 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 • CMS ruling a positive • New product launches • Strong International growth • Turnaround and growth strategy underway