Staar Surgical Company · NASDAQ:STAA
Staar Surgical — Investor Day (November 2019)
53 slides from Staar Surgical's investor day presentation, Nov 8, 2019
Slide 1: 2019 Investor Day Presentation
STAAR Surgical Caren Mason President & CEO 2019 Investor Day Presentation | NASDAQ: STAA November 8, 2019 Exhibit 99.1
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 statements about the Ophthalmic industry, our business and financial results including any of the following: any financial projections, including those
Slide 3: The Future of Refractive Surgery is Lens-Based... The Time for STAAR is Now
The Future of Refractive Surgery is Lens-Based... The Time for STAAR is Now “Intraocular refractive surgery is the next wave of growth in the eyecare space and STAAR is the clear leader in this technology. The success that STAAR has demonstrated in Asia is a leading indicator for what I expect to ha
Slide 4: The Time for STAAR is Now
The Future of Refractive Surgery is Lens-Based... The Time for STAAR is Now Large and Growing Addressable Market (TAM) Strong Financial Performance includes Expanding Margins and Cash Generation Proprietary Lens Technology and Business Model is Driving Industry-Leading Growth
Slide 5: STAAR is Targeting Two Large Markets
TAM STAAR is Targeting Two Large Markets Refractive Today: 4 Million Procedures Annually Refractive Future: Growth refueled by lens-based myopia and presbyopia solutions Myopia Presbyopia * Company estimates of Viable Market Opportunity. Adjustments to TAM based on Epidemiological Data; Distribution
Slide 6: Tailwinds Will Drive Future Market Growth
TAM Tailwinds Will Drive Future Market Growth …to dramatically increase STAAR’s Opportunity. Significant and Increasing Prevalence / Requires Correction Myopia Presbyopia 75-80% of 45-54 Year Olds are Using Correction for Presbyopia** $70 Billion Spend * BHVI, adapted from Holden et al. 2016 Ophthal
Slide 7: Proprietary Lens-Based Technology
Proprietary Lens-Based Technology Over 1 Million ICLs™ Implanted Globally Please Note: The ICL is not visible to other people after implantation. * EVO ICL Patient Registry data on file. 99.4% of Patients Would Elect STAAR’s EVO Implantable Collamer® Lens Again* An Evolution in Visual Freedom™
Slide 8: ICL Advantages
ICL Advantages Proprietary Lens-Based Technology Natural Crystalline Lens Iris Cornea ICL™ Retina Proprietary Collamer Material Quality of Vision Removeable Eco-Friendly Bio-Compatible No Dry Eye Syndrome Upgradeable No Capital Investment Excellent Night Vision Quiet in the Eye Additive UV Protectio
Slide 9: Industry Leading Growth
Industry Leading Growth Projected 22% CAGR 2017-2019 *As reported for Nine-Months Ended September 27, 2019 YTD and not adjusted for constant currency. Currency impact to YTD growth rate is 140bps. ** Quarterly revenue estimate as calculated from company-provided calendarization of 22% (Q1); 27% (Q2)
Slide 10: ICL Unit Growth
Industry Leading Growth ICL Unit Growth Y/Y*… Nine Months YTD 2019 * Select markets for the Nine-Months Ended September 27, 2019 as compared to the Nine-Months Ended September 28, 2018.
Slide 11: Industry Leading Growth Drives Margins and EPS
Industry Leading Growth Drives… Gross Margin Operating Margin GAAP EPS * Nine-Months Ended September 27, 2019 and Nine-Months Ended September 28, 2018. Expanding Margins Expanding GAAP EPS Profitability
Slide 12: Cash Generation and Strong Balance Sheet
Industry Leading Growth Drives… Cash from Operations ($ Millions) Balance Sheet Cash** ($ Millions) Cash Generation Strong Balance Sheet * Nine-Months Ended September 27, 2019 and Nine-Months Ended September 28, 2018. ** Cash, Cash Equivalents and Restricted Cash. The Company raised $78 million (gro
Slide 13: STAAR's Global Eyeprint
STAAR’s Global “Eyeprint” 75 Countries Globally STAAR operates with independent distribution in the remaining countries where the ICL is sold. Hybrid Markets: China | S. Korea | India Potential Future Hybrid Markets Direct Markets: United States | Canada | U.K. | Germany | Spain | Japan
Slide 14: ICL Global Market Share
ICL Global Market Share* * Company Estimates as of October 24, 2019. From < 2% to 6% Est. 2019 Japan 23%
Slide 15: China: EVO Has Captured 14% Market Share
China What’s Going On… EVO Has Captured 14% Market Share* Peak Summer Season = Thousands of ICLs Daily Hospital Waiting Room Surgeon WeChat Posting of EVO Patients * Company Estimates as of October 24, 2019.
Slide 16: China: Consumer Marketing Propels EVO Growth
EVO Only Clinics Paradigm Change Consumer Marketing Propels EVO Growth China What’s Going On…
Slide 17: Japan: Surgeon Support and Consumer Marketing
Surgeon Support + Consumer Marketing + Celebrity-Driven Awareness + EVO ICL Only Clinic “When I woke up… I was so happy that I was about to cry… problems with dry eye and hyperemia have disappeared.” – Rino Sashihara on Twitter HKT48, Top Idol Japan What’s Going On… The Japanese Ophthalmological Soc
Slide 18: Germany and Spain: Strategic Partnerships
The German refractive society expanded recommended range for use of phakic refractive lenses, including EVO from -6.0D to -3.0D* in 2019. Strategic Partnerships Vista Oftalmólogos, 49 eye clinics spanning Spain, France, Portugal and Morocco Smile Eyes Group, 13 eye clinics in Germany and Austria A g
Slide 19: United States: What's Going On
United States What’s Going On… Visian Toric ICL approval returned U.S. to growth in Q4’18 EVO Visian ICL Clinical Trial Imminent Inaugural U.S. Surgeons Council Summit (Dallas) Bringing OUS business model of premium and primary ICL positioning to the U.S. Leading Ophthalmic Surgeons from top markets
Slide 20: United States: Global Media Campaign
United States What’s Going On… Award Winning Global Media Campaign Coming to the U.S. – Two Months Results for this Campaign in St. Louis is 200% Increase in Doc Finder Visits
Slide 21: Promises Made. Promises Kept.
* 2019 YTD is Nine-Months ended September 27, 2019 as reported. **Total Cash at 9/27/19. $39.7M Total Cash deducting $72.6M Net Proceeds from August 2018 secondary also demonstrates significant operational execution above target. STAAR’s Execution Three-Year Financial Outlook Provided at November 20
Slide 22: STAAR's Vision 2020-2022 Strategic Imperatives
STAAR’s Vision 2020-2022 Strategic Imperatives Position EVO Implantable Lenses as a Special and Transformational Pathway to Visual Freedom… Promote Exceptional Desirability to Win Consumer Choice and Social Media Enthusiasm Support the Transformation of the Refractive Surgery Paradigm through Clinic
Slide 23: Financial Outlook
Financial Outlook *Published in Clinical Ophthalmology, Packer, December 2018. 2020-2022 REVENUE GROWTH 25% CAGR by YE 2022 ICL UNIT GROWTH 35% CAGR by YE 2022 PROFITABILITY IMPROVEMENT Profitability Improves balanced by Prudent Investment Consumer Awareness Commercialization Clinical Studies CASH F
Slide 24: Financial Outlook Assumptions: Revenue
Financial Outlook Assumptions 2020-2022 REVENUE EDOF Presbyopia ICL on market in Q2 2020 followed by phased rollout US growth accelerates, preparing key cities for future EVO launch Keep building China, aiming for 25%+ procedure share Continue modest trade-offs of price for volume in mid/low diopter
Slide 25: Financial Outlook Assumptions: Costs and Investments
2020-2022 UNIT COSTS Target $1.5M Reduction in Manufacturing Costs Annually in planning cycle OPERATING EXPENSES Overall Spending Growth Slows in Latter Part of Planning Period R&D Spend as a Percentage of Sales Settles into the Mid-Teens by the end of Planning Period CAPITAL AND OPERATING INVESTMEN
Slide 26: The Future of Refractive Surgery is Lens-Based
www.staar.com www.discoverevo.com The Future of Refractive Surgery is Lens-Based... The Time for STAAR is Now
Slide 27: The New Refractive Paradigm
The New Refractive Paradigm Mark Packer, MD, FACS, CPI President, Mark Packer MD Consulting, Inc. Boulder, Colorado Company Confidential & Proprietary
Slide 28: Personal History with ICL
Personal History with ICL The Implantable Collamer Lens for Myopic Patients, 1997-2005 IDE G960218, STAAR Surgical Company Managing Partner, Drs. Fine, Hoffman & Packer, 2000 – 2012 Clinical Consultant, STAAR Surgical, 2014 – present Packer M. Meta-Analysis and Review: Effectiveness, Safety and Cent
Slide 29: Bilateral Sequential Same Day Surgery
Bilateral Sequential Same Day Surgery. Comprehensive Ophthalmologist Program. Royal Hawaiian Eye Meeting. Kauai. January, 2010.
Slide 30: A Bigger Wow!
A Bigger Wow! “optically superb correction of relatively high degrees of ametropia”1 Seeing well “right off the table”2 McLeod SD. Long-term clinical outcomes and cataract formation rates after posterior phakic lens implantation for myopia. JAMA Ophthalmol. Epub March 3, 2016. Steven S. Lane, MD, qu
Slide 31: A Bigger Wow! Efficacy and Accuracy
A Bigger Wow! Efficacy Index 0.9 – 1.351,2 Accuracy to target3 90.8% within ±0.5 D2 98.7% within ±1.0 D2 Long-term refractive stability4 Efficacy Index = Postoperative UCVA / Preoperative BCVA Packer M. The Implantable Colla ≤ ±0.5 D2 mer Lens with a central port: review of the literature. Clinical
Slide 32: High Patient Satisfaction
High Patient Satisfaction 99.4% of 1,542 patients surveyed stated they would elect to have surgery again1 1. Staar Surgical. Patient Survey; Visian ICL™ (Implantable Collamer Lens) For Nearsightedness; Facts You Need To Know About STAAR Surgical’s Visian ICL; Surgery; Patient Information Booklet. Av
Slide 33: Significant Improvements in Quality of Life
Significant Improvements in Quality of Life 1. Rose K, Harper R, Tromans C, Waterman C, Goldberg D, Haggerty C, Tullo A. Quality of life in myopia. Br J Ophthalmol. 2000 Sep;84(9):1031-4. 2. Ieong A, Hau, S, Rubin GS, Alan B. Quality of Life in High Myopia before and after Implantable Collamer Lens
Slide 34: Traditional Paradigm of Refractive Surgery
Traditional Paradigm of Refractive Surgery Corneal refractive surgery is the “treatment of choice” for low to moderate myopia ≤ 8D1, 2 Considered less invasive than phakic lens surgery2 Phakic lens surgery is restricted to high myopia > 8D3 Complications are “more disabling than those from keratoref
Slide 35: The New LASIK? Why You Should Consider Adopting Phakic IOLs
CRST ® ENS SURGERY THE NEW LASIK? WHY YOU SHOULD CONSIDER DOPTING PHAKIC IOLS
Slide 36: EVO is Disrupting the Traditional Paradigm
EVO is Disrupting the Traditional Paradigm Improved safety over earlier models1 EVO Visian ICL safety and effectiveness today are comparable to those of corneal refractive surgery1-13 EVO demonstrates comparable results in low to moderate myopia13, 14 Packer M. The Implantable Collamer Lens with a c
Slide 37: EVO: Safety and Effectiveness
EVO: Safety and Effectiveness
Slide 38: EVO Safety
Total number of eyes reported Follow Up Weighted Average Safety Index Anterior Subcapsular Cataract Pupillary Block Pigment Dispersion n = 4,196 Up to 5 years 1.15 0.00% (n = 0) 0.04% (n = 1)* 0.00% (n = 0) EVO Safety Peer-reviewed Literature through October 2018 Source: Thirty eight peer-reviewed p
Slide 39: Effectiveness: Refractive Outcomes
Effectiveness: Refractive Outcomes Weighted Average Efficacy Index MRSE Cylinder Visual Acuity Baseline MRSE (range) Post UDVA/ Pre CDVA ±0.5D ±1.0D ≤0.5D ≤1.0D Mean logMAR UDVA 20/20 or better EVO -9.81 D (-5.98 to -14.62)3 1.04 (0.90 – 1.35)3 90.8%3 98.7%3 94.0%6 100%6 -0.023 97.0%8 SMILE -4.93 D
Slide 40: Equivalent Safety and Effectiveness in Both Groups
Equivalent Safety and Effectiveness in both Groups: Group 1 < - 6D Group 2 ≥ - 6D 1. Kamiya K, Shimizu K, Igarashi A, et al. Posterior chamber phakic intraocular lens implantation: comparative, multicentre study in 351 eyes with low-to-moderate or high myopia. Br J Ophthalmol. 2017 Jun 13. “ICL impl
Slide 41: Satisfaction
Satisfaction EVO, SMILE and LASIK: Levels of Satisfaction PMA P020050/S12: FDA Summary of Safety and Effectiveness Data (ALLEGRETTO WAVE® Eye-Q Excimer Laser) Vestergaard A, Ivarsen AR, Asp S, et al. Small-incision lenticule extraction for moderate to high myopia: Predictability, safety, and patient
Slide 42: EVO is Disrupting the Traditional Paradigm
EVO is Disrupting the Traditional Paradigm EVO is disrupting the refractive surgery paradigm Answers historical safety concerns regarding phakic lenses1,16-22 Demonstrates effectiveness across a broad range of refractive error13 Provides safety and effectiveness outcomes comparable to corneal refrac
Slide 43: The New Paradigm
The New Paradigm Evidence of the new paradigm Literature comparing EVO and corneal refractive surgery Positioning of EVO in clinical practice The changing competitive landscape
Slide 44: The New Paradigm: Literature
Ganesh et al. Matched population comparison of visual outcomes and patient satisfaction between 3 modalities for the correction of low to moderate myopic astigmatism. Clinical Ophthalmology 2017:11 1253-1263 The New Paradigm: Literature Random assignment to EVO Toric, fs-LASIK or ReLEx SMILE 30 eyes
Slide 45: Matched Population Comparison of Three Modalities
Matched population comparison of visual outcomes and patient satisfaction between 3 modalities for the correction of low to moderate myopic astigmatism1 1. Ganesh et al. Matched population comparison of visual outcomes and patient satisfaction between 3 modalities for the correction of low to modera
Slide 46: The New Paradigm: Clinical Practice Positioning of EVO Visian ICL
The New Paradigm: Clinical Practice Positioning of EVO Visian ICL by Jose F Alfonso MD PhD1 Alfonso JF. Seven years of clinical experience with the EVO Visian ICL. Presentation at 2018 STAAR Experts Meeting, Vienna Refractive Error (Diopters) Age (yrs)
Slide 47: Purely Lens-Based Refractive Surgery Practice
The New Paradigm: Clinical Practice Purely lens-based refractive surgery practice1 Vandekerckhove, K. Refractive Surgery Without a Laser. CRST Europe Oct. 2018
Slide 48: The New Paradigm: Competitive Landscape
The New Paradigm: Competitive Landscape New phakic lenses recently introduced to the market Posterior chamber lens Central port design History of phakic IOLs How many have stood the test of time? ICL has demonstrated long term safety Over 1,000,000 ICLs implanted with 20+ years of experience1,2 Coll
Slide 49: ICL Momentum in the Global Market
The New Paradigm: “ICL momentum in the global market”2 Outstanding effectiveness and improved safety over earlier models1 Over 630,000 implants to date1 99.4% would elect EVO surgery again1 Expanding adoption for low to moderate myopia2 Packer M. The Implantable Collamer Lens with a central port: re
Slide 50: The New Paradigm
The New Paradigm 1,542 patients surveyed. Patient Survey. STAAR Surgical ICL Data Registry, 2018. 99.4% would elect EVO surgery again1 1,000,000+ implants1 20+ years of experience4 Benefits of Posterior chamber phakic IOL4 Collamer material2,4 630,000+ EVO ICLs1 Outstanding safety, effectiveness and
Slide 51: EVO Visian ICL Supplemental Lens
EVO Visian ICL Supplemental Lens Expanding indication for enhancement of pseudophakic refractive error Safety and effectiveness demonstrated in the scientific literature1-5 Reported enhancement rates up to 21% in patients with a history of corneal refractive surgery6 Chiou AG, Bovet J, de Courten C.
Slide 52: EVO+ Visian ICL with Aspheric (EDOF) Optic
EVO+ Visian Implantable Collamer Lens (ICL) with Aspheric (EDOF) Optic Promising new technology for presbyopia and correction of refractive error Prospective, Multicenter Clinical Evaluation (Study CP17-01) Currently under review by STAAR’s Notified Body for CE Mark Primary Performance Endpoint: Ach
Slide 53: Evolution in Visual Freedom
Evolution in Visual Freedom™ “~@ STAARSURGICAL™