Staar Surgical Company · NASDAQ:STAA
Staar Surgical — Investor Presentation (January 2007)
39 slides from Staar Surgical's investor presentation, Jan 11, 2007
Slide 1: STAAR Surgical
STAAR Surgical NASDAQ - STAA Dave Bailey, President CEO
Slide 2: Forward-Looking Statements
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 op
Slide 3: STAAR Surgical Is
STAAR SURGICAL IS............ An Ophthalmic Device Company focused on bringing innovative Refractive and Cataract Lens Technologies to market that deliver Superior Clinical Outcomes.
Slide 4: Investment Considerations
Investment Considerations Large and growing addressable market - High Growth, High Margin Leadership in phakic implants - the Visian Implantable Collamer Lens. Next Generation a Reality Opportunity to rebuild Share in the Cataract market Poised for Growth . Favorable market trends . Unique and Innov
Slide 5: Visian ICL
Visian ICL(tm)
Slide 6: Visian Advantages
Visian Advantages "Correct the Vision NOT the eye"; Architecture and Anatomy of the Cornea is completely unchanged with the ICL. Ease of use for the Surgeon - existing skill set Patient friendly - topical anesthesia, small incision, quick rehabilitation, "wow" for patient. Exceptional clinical outco
Slide 7: Vision Correction Market
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 to PRK - 10 to 15% in the US. Driven by a concern over cornea-based procedur
Slide 8: ICL Market
ICL Market Target at -7.5D and above. Adjusted population in the US of six million eyes per year. Targeted penetration rate of this market is 10% over time - 600,000 procedures Adjusted equivalent in International is 100 million eyes per year ! In this target market approx 40% of patients will have
Slide 9: Country Penetration
Country Penetration % Switzerland 3.8% Korea 3.2% Spain 2.9% Scandinavia 2.8% Benelux 1.8% South America 0.6% Germany 0.5% Middle East 0.5% UK 0.2% Italy 0.2% France 0.2% India 0.1% Room for growth - penetration as a % LASIK
Slide 10: Sales of ICLs at and below -10.0
Sales of ICLs at and below -10.0
Slide 11: Not a Niche Market - the Facts
Not a Niche Market - the Facts Suspicious corneas are not segmented to high myopia 10/15 % of the US LASIK market is now surface based treatments due to concern over the Cornea Some international surgeons have a 25% implant to LASIK ratio !! 33% implants in US are at or below -8D Dry eye is not limi
Slide 12: PRK - Driven by the Fear of Ectasia
PRK - Driven by the Fear of Ectasia Based on the perception that PRK is a safer corneal surgery than LASIK it has quickly grown to 10 to 15% of the volume in most practices and 100% of a few The view it is safer has now been strongly challenged if not repudiated - thin flap LASIK indistinguishable.
Slide 13: Which Eye Has Better Vision?
Which Eye Has Better Vision? 1 Day (n=27) 3 Days (n=27) 1 Week (n=30) 1 Month (n=42) LASIK w/ IntraLase 96 100 83 69 PRK 0 0 0 7 Both Same 4 0 17 24 % Eyes
Slide 14: Which Eye Has More Pain?
Which Eye Has More Pain? Through One Month Postoperative 1 Day (n=33) 3 Days (n=33) 1 Week (n=33) 1 Month (n=42) LASIK w/ IntraLase More Pain 0 0 0 5 PRK More Pain 97 97 52 19 Both Same 3 3 48 76 % Eyes
Slide 15: PRK Vs ICL/TICL
PRK Vs ICL/TICL If you are uncomfortable doing corneal surgery (LASIK) you should not do corneal surgery (PRK). Steve Slade MD The ICL is the answer for 10% to 15% of US volume on this basis alone - 140 to 200,000+ units TICL randomised Navy study vs PRK - TICL better across all timelines and respec
Slide 16: China
China 2 Training Centers established, 3 additional in the process of being established Recruiting for local based MD proctor Proctoring program started (5 clinics proctored recently) Key focus is to develop surgical skills (most surgeons still do ECCE, not phaco) Strong growth opportunity mid term -
Slide 17: India
India Focus on high price refractive segment Currently appr 80k laser treatments done ICL and TICL approved for importation - awaiting formal approval High potential due to average cornea in India being below 500 microns Plans: Training centers in the process of being established. Recruited speciali
Slide 18: US Visian Launch Update
US Visian Launch Update 306 surgeons proctored in 2006, strict surgical protocol. Overwhelmingly good experience - "my happiest patients" Certification courses AAO; 65 attendees, 500 at CME event, live surgery feed - bilateral Toric Outstanding User group meeting - 60 attendees Five eye proctoring r
Slide 19: Tools to facilitate the mindset change
Tools to facilitate the "mindset" change Investment in Refractive and Selling expertise - ongoing Practice assessments to ensure successful integration - ongoing User group meetings; ASCRS,ESCRS,AAO. Five year trial data - key safety parameters LASIK/PRK comparisons - low myopia, randomized. Contral
Slide 20: Strong Safety Profile - Visian ICL
Strong Safety Profile - Visian ICL Gold Standard FDA trial - 526 eyes, five year follow up 73% follow up at four years - 59% follow up at five years Clinically significant anterior sub capsular cataract rate at five years - 1.3% ! No other types observed since PMA submitted Cumulative endothelial ce
Slide 21: Next Generation Visian Toric ICL
Next Generation Visian Toric ICL
Slide 22: Outcomes - Highlights
Outcomes - Highlights Population started with over -9D myopia and -2D Cylinder ALL patients reported they were happy with the surgery - 98% VERY or EXTREMELY happy Over 77% could see as well or BETTER without any correction at 1 year post-op than they could with their best spectacle correction pre-o
Slide 23: Regulatory Status - TICL
Regulatory Status - TICL Clinical module submitted to FDA April 28th 2006 Manufacturing module submitted July 2006 Formal feedback received November 20th - Written requesting more analysis of current data Submission will trigger new 180 day timeline - business as usual for FDA. Examples - stratify t
Slide 24: Competitive Landscape
Competitive Landscape Alcon - Determined to enter at -6D but rotational and cataract issues. Anterior implant no toric version Vivarte (Zeiss / Ioltech) withdrawn from the market due to Endothelium cell loss after 3 years Launch of foldable Artisan in Europe, causing limited enthusiasm I prefer the
Slide 25: Worldwide Cataract Market
Worldwide Cataract Market 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
Slide 26: US Cataract Market
US Cataract Market 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 Presbyopic IOLs (accommodating and multifocal) and RLE will represent $250M of revenues by 2010 down from an
Slide 27: STAAR's Opportunity
STAAR's Opportunity Year Units(000) % 2005 184 5.8% 2004 191 6.8% 2003 212 8.0% 2002 227 8.4% 2001 249 9.6% 2000 283 11.1% 1999 309 12.4% 1998 253 10.1%
Slide 28: US IOL Market Share - 2005
US IOL Market Share - 2005 Units (000) % Alcon 1,480 49.9% AMO 800 27.0% Bausch & Lomb 350 11.8% STAAR 184 6.1% Eyeonics 22 0.7% Other 131 4.5% Total: 2,967 100.0%
Slide 29: 2006/2007 IOL Initiatives
2006/2007 IOL Initiatives Collamer Aspheric IOL - 11/06. Clinical evaluations underway. Launch Q1 07 Silicone Aspheric IOL - April 2007 launch Preloaded Silicone Aspheric Injector - 10/07. January 2008 Launch
Slide 30: Players - Now
Players - Now Material Material Material Silicone Acrylic Other Plate Bausch & Lomb STAAR STAAR Three-Piece AMO Bausch & Lomb STAAR Alcon STAAR One-Piece Alcon AMO Aspheric AMO Bausch & Lomb STAAR * Alcon AMO STAAR * Blue-Blocking Alcon Toric STAAR Alcon Accommodating Eyeonics Multifocal Alcon AMO *
Slide 31: 2007 PreLoad Entrants
2007 PreLoad Entrants Material Material Material Silicone Acrylic Other Alcon AMO Bausch & Lomb STAAR
Slide 32: Key Differentiating Characteristics
Key Differentiating Characteristics Collamer Material Collagen and Co-Polymer Induces fewer Higher Order Aberrations than other lens materials Exceptional Quality of Vision Significant Biocompatibility Polyimide Haptics Excellent shape memory for optimal Centration and Lens Fixation Toric IOL Small
Slide 33: Q3 Recap
Q3 Recap Global Sales - $13.1 million 13% increase over Q3 2005 ICL sales US - $1.2 million - second full quarter after launch Intl - $1.5 million - 54% increase in a seasonally week quarter Global cataract sales $10.1 million - 4% decrease over Q3 2005 US/Intl IOL sales flat First signs of reversal
Slide 34: Q3 Recap
Q3 Recap Gross Profit - 48.7% Highest since Q3 2004 Continued improvement expected - geographic and product mix SG&A & R&D - $9.1 million Increased spending related to ICL marketing, Toric ICL launch activities, new product development Net loss - $0.11 per share $.02 included in net loss related to
Slide 35: Q4 Preliminary Outlook
Q4 Preliminary Outlook Global Sales - $15.2 million 26 % increase over Q4 2005 ICL sales Global - 189% increase QTR, 129% increase full year, 21.5% of total sales for year US - $1.1 million - third full quarter after launch US Cataract sales Growth Vs Q4 2005, reduction in total year decline Vs prio
Slide 36: Cash
Cash Q3 Cash - $8.3 million, ( Q4 - ^7.8M$) 32% sequential decrease in cash used in ops $177K all in cash decrease vs. Q2 at $1.1M & Q1 at $3.0M Liquidity needs further supported by: $3.0 million US line of credit $2.4 million Intl lines of credit - $700K available $1.5 million US lease lines of cre
Slide 37: Long-Term Operating Model
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% $
Slide 38: Investment Considerations
Investment Considerations Large and growing addressable market - High Growth, High Margin Leadership in phakic implants - the Visian Implantable Collamer Lens. Next Generation a reality. Opportunity to rebuild Share in the Cataract market Poised for Growth . Favorable market trends . Unique and Inno
Slide 39: Thank You
Thank You STAAR Surgical Company
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