Staar Surgical Company · NASDAQ:STAA
Staar Surgical — Jefferies Healthcare Conference 2016
27 slides from Staar Surgical's conference presentation, Jun 10, 2016
Slide 1: Jefferies Healthcare Conference June 10, 2016
J EFFERIES H EALTHCARE CONFERENCE J UNE 10, 2016 Evolution in Visual Freedom ™
Slide 2: Forward-Looking Statements
™ ™ BUILDING A FOUNDATION FOR CONSISTENT GROWTH FORWARD - LOOKING STATEMENTS All statements in this presentation that are not statements of historical fact are forward - looking statements, including stateme nts about any of the following: any projections of earnings, revenue, sales, profit margins,
Slide 3: STAAR Surgical Is a Leading Developer of Premium Implantable Lenses
™ ™ BUILDING A FOUNDATION FOR CONSISTENT GROWTH S TAAR SURGICAL IS … … a Leading Developer, Manufacturer and Marketer of Premium Implantable Lenses for Refractive Vision Correction Implantable Collamer® Lens or “ICL”™ - A Premium Refractive Procedure Delivering Visual Freedom to the Patient in Need
Slide 4: STAAR Surgical Is Also a Developer of Cataract Lenses
™ ™ BUILDING A FOUNDATION FOR CONSISTENT GROWTH S TAAR SURGICAL IS ALSO … 28% Q1 YTD 2016 Lens Revenue … a Developer, Manufacturer and Marketer of Premium Implantable Lenses for Cataract Lens Replacement • Intraocular Lens (IOL) - Used to Replace the Natural Lens after Cataract Surgery
Slide 5: Over One Million Lens Implants with Exclusive Collamer Material
™ ™ BUILDING A FOUNDATION FOR CONSISTENT GROWTH O VER O NE M ILLION L ENS I MPLANTS (ICL’ S AND IOL’ S ) WITH E XCLUSIVE C OLLAMER ® M ATERIAL … » Biocompatibility, which means compatible with your body’s natural chemistry, is a key advantage of Collamer. » A layer of fibronectin is believed to form
Slide 6: Global Leader in Phakic IOL ICL Implantation
™ ™ G LOBAL L EADER IN P HAKIC IOL “ICL” I MPLANTATION 6 CAGR: 9% T OTAL R EVENUE 17% ICL U NITS 10 - Year Total Revenue & ICL Unit Growth 85% of Total Revenue Outside the U.S.
Slide 7: Current Market: LVC Refractive Procedures
™ ™ CURRENT MARKET: LVC REFRACTIVE PROCEDURES ▪ China 875,000 ▪ USA 630,000 ▪ India 180,677 ▪ Brazil 162,640 ▪ Germany 135,340 ▪ Italy 105,229 ▪ UK 97,540 ▪ Spain 92,920 ▪ Japan 82,650 ▪ South Korea 81,250 ▪ ROW 1,196,261 Source: 2015 Market Scope 3.6M Global LVC Refractive Procedures Eve Torres Gra
Slide 8: Myopia a Growing Concern in Asia: Million in China Suffering from High Myopia
™ ™ MYOPIA A GROWING CONCERN IN ASIA: 30 M ILLION IN C HINA S UFFERING FROM H IGH M YOPIA * Excerpts from Published Articles on Myopia Adjusting Vision Health Policies: Now or Never -- A Research Report on the Vision Health of Chinese People "The number of people with high myopia alone is far greate
Slide 9: Myopia a Growing Concern in Asia
™ ™ MYOPIA A GROWING CONCERN IN ASIA Excerpts from Published Articles on Myopia “ East Asia has been gripped by an unprecedented rise in myopia, also known as short - sightedness. Sixty years ago, 10 – 20% of the Chinese population was short - sighted. Today, up to 90% of teenagers and young adults
Slide 10: Myopia a Growing Global Concern
™ ™ MYOPIA A GROWING GLOBAL CONCERN… * H IGH M YOPIA C OULD I MPACT A LMOST 1 B ILLION P EOPLE BY 2050 Excerpts from Published Articles on Myopia “ In the journal Ophthalmology, a new paper looks at worldwide trends in myopia by doing a meta - analysis of 145 studies involving 2.1 million total part
Slide 11: What's Possible? Exponential Growth
™ ™ BUILDING A FOUNDATION FOR CONSISTENT GROWTH W HAT ’ S P OSSIBLE ?... E XPONENTIAL G ROWTH » Build the Visual Freedom Market for Myopia… Exponential Growth of Patients with Mid - to - High Myopia » Move out of the shadows of other Refractive Procedures such as LASIK and PRK… Premium and Primary I
Slide 12: What's Possible? 10X Our Current Volume
™ ™ W HAT ’ S P OSSIBLE ? 10X O UR C URRENT V OLUME 12 1 M ILLION ICL’ S A NNUALLY … G ROW THE M ARKET
Slide 13: Our Focus 2015-2017
™ ™ » Engender Culture of Quality - FDA Remediation and Systemic Change » Build R & D Continuum: Myopia/ Presbyopia/ Cataract Care » Develop Global Clinical Validation and Clinical Utility Competency » Create an Extraordinary Surgeon and Patient Experience » Invest in Proprietary Technology and Proc
Slide 14: 2015 Strategic Priorities/Accomplishments
™ ™ » Met all internal requirements on budget and on time for FDA r emediation and Quality System rebuild » Developed new employee led Culture of Quality initiative reinforcing Quality focus at STAAR » Achieved Record Total Revenue and ICL Unit Sales » Hired top talent in R&D, Clinical and Medical A
Slide 15: 2015 Strategic Priorities/Accomplishments
™ ™ » Stabilized production with significant backorder issues resolved by mid - year and infrastructure assessment completed » Recruited clinically lauded ophthalmic surgeons for Working Groups with special emphasis on Presbyopia » Completed Intellectual P roperty patent estate review and secured tr
Slide 16: 2016 Strategic Priorities
™ ™ » FDA Remediation and Continuation of Quality System Rebuild - $2.1M » Create the Visual Freedom Market for Implantable Lenses - $2.0M » Develop Strategic Partnerships with Large Transformational Partners » Establish Certified ICL Training Institute “CITI” – Fortify Surgeon Skills » Begin Clinic
Slide 17: 2016 Strategic Priority: FDA Remediation and Quality System Rebuild
™ ™ 2016 STRATEGIC PRIORITY FDA Remediation and Quality System Rebuild » Meet FDA remediation internal plan commitments » Acquiring and validating new Quality Management System » Continuing employee ownership as Culture of Quality » Meet remediation budget of $2.21 million
Slide 18: 2016 Strategic Priority: Create the Visual Freedom Market
™ ™ 2016 STRATEGIC PRIORITY Create the Visual Freedom Market for Implantable Lenses » Rebranded STAAR – May 2016 » Launched Evolution in Visual Freedom™ Global Websites by Country… discovervisianicl.com discoverEVO.com » Launching EVO+ (larger optic lens) beginning Q2 in Europe » Launching EVO in Ca
Slide 19: 2016 Strategic Priority: Begin Clinical Validation
™ ™ 2016 STRATEGIC PRIORITY Begin Clinical Validation – Regulatory Rebirth - Proof EVO ™ Visian ICL » Addressing FDA data requests related to the MICL Post - Approval Studies – In Process » Requested a pre - IDE meeting for EVO™ Visian ICL with the FDA » Funded Independent Meta - Analysis of 10 Year
Slide 20: 2016 Strategic Priority: Innovate and Develop Products
™ ™ 2016 STRATEGIC PRIORITY Innovate and Develop Products, Materials, Delivery Systems » Will perform first - in - man clinical trial to assess ICL with Extended Depth of Field (EDOF) for Presbyopic Patient … "Need to Read" » Completing Pre - Loaded Injector development for ICL » Completing Cataract
Slide 21: 2016 Strategic Priority: Develop Strategic Partnerships
™ ™ 2016 STRATEGIC PRIORITY “ We believe that our partnership with STAAR will provide a strong collaboration projected to include surgeon training, clinical studies, patient registries, local inventory including the more custom Toric lenses, patient information both in person and through digital com
Slide 22: 2016 Strategic Priority: Patient Outreach
™ ™ 2016 STRATEGIC PRIORITY PATIENT OUTREACH – EDUCATE/IMPLANT
Slide 23: Recent Financial Results: Q1 2016 GAAP
™ ™ 23 Income Statement ($ millions, except per share) 6 - Month 4Q15 - 1Q16 6 - Month 4Q14 - 1Q15 Revenue $ 40.1 $ 35.4 Gross Profit $ 27.7 $ 22.3 Gross Profit Margin 68.4% 62.9% Operating Expenses $ 37.8 $ 27.6 Other Income (Expense) $ 0.4 $ (1.0) Income (Loss) Before Taxes $ (9.7) $ (6.3) Net Inc
Slide 24: Recent Financial Results: 6-Month Non-GAAP Comparison
™ ™ 24 Income Statement ($ millions, except per share) 6 - Month 4Q15 - 1Q16 6 - Month 4Q14 - 1Q15 Revenue $ 40.1 $ 35.4 Gross Profit $ 28.2 $ 22.3 Gross Profit Margin 68.4% 62.9% Operating Expenses $ 31.5 $ 27.6 Other Income (Expense) $ 0.4 $ (1.0) Adj. Income (Loss) Before Taxes $ (2.8) $ (6.3) Ad
Slide 25: Recent Financial Results: 6-Month Non-GAAP Comparison
™ ™ 25 R ECENT F INANCIAL R ESULTS 6 - M ONTH N ON - GAAP C OMPARISON * Adjusted Net Income ($ millions, except per share) 6 - Month 4Q15 - 1Q16 6 - Month 4Q14 - 1Q15 GAAP Net Income (Loss) $ (8.9) $ (4.9) Foreign Currency Impact $ (0.2) $ 1.1 Stock - Based Compensation Expense $ 8.0 $ 0.9 Remediati
Slide 26: What's Possible? Exponential Growth
™ ™ BUILDING A FOUNDATION FOR CONSISTENT GROWTH W HAT ’ S P OSSIBLE ? E XPONENTIAL G ROWTH » Build the Visual Freedom Market for Myopia… Exponential Growth of Patients with Mid - to - High Myopia » Move out of the shadows of other Refractive Procedures such as LASIK and PRK… Premium and Primary ICL
Slide 27: Jefferies Healthcare Conference June 10, 2016
J EFFERIES H EALTHCARE CONFERENCE J UNE 10, 2016 Evolution in Visual Freedom ™
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