Staar Surgical Co 8-K, filed Jan 13, 2020
Staar Surgical Co (STAA)
About this 8-K
Staar Surgical Co filed this 8-K on January 13, 2020.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported):
STAAR Surgical Company
(Exact Name of Registrant as Specified in Charter)
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Registrant’s Telephone Number, Including Area Code:
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(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1 933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure.
On January 13, 2020, STAAR Surgical Company (the “Company”) published a press release reporting selected preliminary financial results for the quarter and fiscal year ended January 3, 2020, a copy of which is furnished as Exhibit 99.1 to this Report and is incorporated herein by this reference. The financial information is unaudited and subject to adjustment in the final audited financial statements to be filed with the Company’s Annual Report on Form 10-K. The Company expects to report its complete 2019 financial results on its fourth-quarter and full-year earnings call, which it will hold later in the first quarter of 2020.
On January 13, 2020, the Company issued a press release announcing CE Mark approval from its European Notified Body, DEKRA, expanding the indications of use for the EVO/EVO+ and Visian implantable Collamer lenses (ICL) for myopia and hyperopia, and EVO/EVO+ and Visian toric implantable Collamer lenses for myopia and hyperopia with astigmatism as a supplemental lens in post-cataract IOL (intraocular lens) surgery patients. A copy of the press release is furnished as Exhibit 99.2 to this Report and is incorporated herein by this reference.
Representatives of the Company will give presentations to investors commencing on January 13, 2020. A copy of the slide presentation they will use in their presentations is furnished as Exhibit 99.3 to this Report and is incorporated herein by this reference.
The information furnished herewith pursuant to Item 7.01 of this Current Report, including Exhibits 99.1, 99.2 and 99.3 shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in Item 7.01 of this Current Report shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report, regardless of any general incorporation language in the filing.
Item 9.01 Financial Statements and Exhibits
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99.1 99.2 99.3 |
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Press release of the Company dated January 13, 2020. |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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STAAR Surgical Company |
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January 13, 2020 |
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/s/ Caren Mason |
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Caren Mason |
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President and Chief Executive Officer |
Exhibit 99.1
STAAR Surgical Reports Preliminary Fourth Quarter Net Sales Growth of 25%
Achieves 33% ICL Unit Growth for Fiscal 2019
Provides Initial Outlook for Fiscal 2020
LAKE FOREST, CA, January 13, 2020--- STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, today provided preliminary results for the fourth quarter and fiscal year ended January 3, 2020. The Company expects fourth quarter and fiscal year net sales to increase approximately 25% and 21% over the prior year periods, respectively. Total net sales for the fourth quarter and fiscal year are expected to be approximately $38.9 million and $150.2 million, respectively, as compared to Company outlook of $37.6 million and $149.0 million most recently provided on November 8, 2019. Fourth quarter GAAP earnings per share is expected to be approximately $0.05, exceeding the current $0.02 consensus analyst estimate.
“The preliminary sales and unit growth results we are reporting today demonstrate STAAR’s ability to deliver on our stated financial commitments that support continued market share momentum for our ICL family of products and paradigm change in refractive vision correction to our lens-based solutions,” said Caren Mason, President and CEO of STAAR Surgical. “For the 2019 fiscal year preliminary earnings per share nearly doubled to approximately $0.21 driven by 33% global ICL unit growth and operating expense discipline, underscoring STAAR’s standing as one of the few publicly-traded growth medical technology companies with GAAP earnings profitability. On the regulatory front we also announced today that we have won a new CE Mark approval for the use of our ICL as a supplemental lens for the many post-cataract-surgery IOL patients who may be unhappy because they find themselves back in glasses or disposable contact lenses. Following another year of strong performance in 2019, we now fully turn our attention to achieving the financial and operating targets we recently outlined for the next three-year planning period.”
The Company also today provided an initial outlook for fiscal year 2020 including total net sales growth, year-over-year, in the range of 16% to 20% with a mid-point of 18%, representing approximately $177.2 million in fiscal 2020 total net sales, and also reaffirmed expectations for a 25% total net sales CAGR for the fiscal 2020-2022 three-year planning period. STAAR expects net sales attributable to its non-core “Other Products” business segment will decline by approximately $3 million for fiscal year 2020 as the Company continues to phase out certain lower margin, non-strategic “Other Products” while simultaneously investing more resources in the core ICL business segment, which the Company expects will continue its strong trajectory of growth. The Company anticipates total net sales growth, on an annual basis, will accelerate over the three-year planning period driven by new product catalysts and increasing adoption by surgeons and patients of the Company’s proprietary EVO Visian ICL family of lenses. GAAP earnings per share for fiscal 2020 is expected to be similar to fiscal 2019 on a full-year basis as the Company incurs one-time expenses related to its EVO clinical trial in the U.S. and makes strategic sales and marketing investments ahead of accelerating sales growth in fiscal 2021 and 2022.
STAAR expects to report its complete 2019 financial results on its fourth-quarter and full-year earnings call on or about February 26, 2020 and provided today’s information due to investor meetings taking place January 13-14, 2020. The financial information in this release is unaudited and subject to adjustment in the final audited financial statements to be filed with the Company’s Annual Report on Form 10-K.
STAAR, which has been dedicated solely to ophthalmic surgery for over 30 years, designs, develops, manufactures and markets implantable lenses for the eye with companion delivery systems. These lenses are intended to provide visual freedom for patients, lessening or eliminating the reliance on glasses or contact lenses. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR’s lens used in refractive surgery is called an Implantable Collamer® Lens or “ICL”, which includes the EVO Visian ICL™ product line. More than 1,000,000 Visian® ICLs have been implanted to date and STAAR markets these lenses in over 75 countries. To learn more about the ICL go to: www.discovericl.com. Headquartered in Lake Forest, CA, the company operates manufacturing and packaging facilities in Aliso Viejo, CA, Monrovia, CA and Nidau, Switzerland. For more information, please visit the Company’s website at www.staar.com.
Forward-Looking Statements
This news release contains forward-looking statements. These statements include but are not limited to statements regarding the potential market and commercial and medical significance of the Visian ICL family of products in the market, and our ability to obtain and maintain regulatory market approval. Forward-looking statements are based on our current expectations or beliefs regarding future events or circumstances, and you should not place undue reliance on these statements. Such statements involve known and unknown risks, uncertainties, assumptions and other factors, many of which are out of STAAR’s control and difficult to forecast that may cause actual results to differ materially from those that may be described or implied in the forward-looking statements. STAAR cannot be certain about the commercial success of the Visian ICL family of products in any market. For a discussion of certain other risks, uncertainties and other factors affecting the statements contained in this news release, see STAAR’s Annual Report on Form 10-K for the year ended December 28, 2018, under the caption “Risk Factors,” which is on file with the SEC and available in the “Investor Information” section of STAAR’s website under the heading “SEC Filings”. Except as required by law, STAAR assumes no, and hereby disclaims any, obligation to update any of the foregoing or any other forward-looking statements. STAAR nonetheless reserves the right to make such updates from time to time by press release, periodic report or other method of public disclosure without the need for specific reference to this news release. No such update shall be deemed to indicate that other statements not addressed by such update remain correct or create an obligation to provide any other updates.
CONTACT:Investors & Media
Brian Moore
Sr. Director, Investor, Media Relations and Corporate Development
(626) 303-7902, Ext. 3023
bmoore@staar.com
Exhibit 99.2
STAAR Surgical Gains Supplemental Lens Approval for EVO Visian ICL to Target Post-Cataract Market Opportunity
CE Mark Approval for EVO Visian ICL Product Family as a Supplemental Lens Offers Unhappy Cataract Patients Opportunity to Achieve Visual Freedom
CE Mark Addresses Post-Cataract-Surgery Myopia, Hyperopia and Astigmatism Patients with Residual Refractive Error
LAKE FOREST, CA, January 13, 2020--- STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, is today announcing the Company has gained CE Mark approval for use of its ICL as a supplemental or “piggyback” lens in post-cataract IOL surgery patients (pseudophakics). A supplemental EVO ICL is placed in front of the cataract IOL lens in post-cataract patients just like the EVO ICL is placed in front of the human crystalline lens in refractive patients. The EVO ICL in the post-cataract patient is supplemental to the cataract IOL. The approval is for STAAR’s EVO/EVO+ and VISIAN® Implantable Collamer® Lenses for myopia and hyperopia, and EVO/EVO+ and VISIAN® Toric implantable Collamer® Lenses for myopia and hyperopia with astigmatism.
Approximately 28 million eyes undergo cataract surgery each year globally.1 Data from the European Registry of Quality Outcomes for Cataract and Refractive Surgery suggest that at least 13% of cataract patients have significant residual postoperative refractive error that may be corrected.2 Additional data suggests that up to 21% of patients with a history of corneal refractive surgery, including prior LASIK or RK, may need an enhancement procedure to achieve acceptable vision without eyeglasses or disposable contact lenses.3
“EVO ICL, implanted as a supplemental lens, offers an important safety net for a cataract patient’s vision and provides the opportunity for excellent uncorrected visual acuity and a spectacle-free lifestyle,” said ophthalmologist Dr. Mark Packer, President of Mark Packer MD Consulting, Inc. “Multiple authors of peer-reviewed, scientific publications have already reported successful deployment of the EVO ICL as a supplemental lens for the correction of residual refractive error following cataract surgery. The ability to enhance the outcomes of cataract surgery is essential for the success of a cataract surgeon’s practice, particularly when caring for patients who have already demonstrated their commitment to a spectacle-free lifestyle by having had LASIK when they were younger. The outstanding effectiveness and demonstrated safety of EVO implantation in phakic eyes make EVO an excellent choice for correction of residual pseudophakic refractive error, especially in those eyes with a history of prior corneal refractive surgery. Regulatory approval of the EVO ICL family of lenses for use as a supplemental lens will now provide surgeons with greater confidence to use this critical tool to help patients who are dissatisfied with residual refractive error after cataract surgery.”
Globally, an estimated 131 million eyes had cataract surgery for the five-year period from 2015 through 2019 according to Market Scope, an independent Healthcare data market research firm.4
“The ICL’s new CE Mark approval expands the indications for the EVO Visian ICL product family to include a much-needed therapeutic option for the population of post-surgery cataract patients that find themselves back in glasses or contact lenses,” said Caren Mason, President & CEO of STAAR Surgical. “This new approval demonstrates the safety,
1 Market Scope, September 2019.
2 Lundström M, Barry P, Henry Y, Rosen P, Stenevi U. Evidence-based guidelines for cataract surgery: guidelines based on data in the European Registry of Quality Outcomes for Cataract and Refractive Surgery database. J Cataract Refract Surg. 2012;38(6):1086–1093.
3 Vrijman V, van der Linden J W, van der Meulen I J E, et al. Multifocal intraocular lens implantation after previous corneal refractive laser surgery for myopia. J Cataract Refract Surg 2017 Jul;43(7):909-914.
4 Market Scope, IOL Market Report, A Global Analysis, 2016, 2017, 2018, 2019.
versatility and significant market opportunity for our EVO ICL family of lenses and supports those surgeons who are actively building lens-based practices.”
About STAAR Surgical
STAAR, which has been dedicated solely to ophthalmic surgery for over 30 years, designs, develops, manufactures and markets implantable lenses for the eye with companion delivery systems. These lenses are intended to provide visual freedom for patients, lessening or eliminating the reliance on eyeglasses or contact lenses. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR’s lens used in refractive surgery is called an Implantable Collamer® Lens or “ICL”, which includes the EVO Visian ICL™ product line. More than 1,000,000 Visian® ICLs have been implanted to date and STAAR markets these lenses in over 75 countries. To learn more about the ICL go to: www.discovericl.com. Headquartered in Lake Forest, CA, the company operates manufacturing and packaging facilities in Aliso Viejo, CA, Monrovia, CA and Nidau, Switzerland. For more information, please visit the Company’s website at www.staar.com.
Forward-Looking Statements
This news release contains forward-looking statements. These statements include but are not limited to statements regarding the market opportunity and potential commercial and medical significance of the EVO Visian ICL family of products in the market, and our ability to obtain and maintain regulatory market approval. Forward-looking statements are based on our current expectations or beliefs regarding future events or circumstances, and you should not place undue reliance on these statements. Such statements involve known and unknown risks, uncertainties, assumptions and other factors, many of which are out of STAAR’s control and difficult to forecast that may cause actual results to differ materially from those that may be described or implied in the forward-looking statements. STAAR cannot be certain about the commercial success of the Visian ICL family of products in any market. For a discussion of certain other risks, uncertainties and other factors affecting the statements contained in this news release, see STAAR’s Annual Report on Form 10-K for the year ended December 28, 2018, under the caption “Risk Factors,” which is on file with the SEC and available in the “Investor Information” section of STAAR’s website under the heading “SEC Filings”. Except as required by law, STAAR assumes no, and hereby disclaims any, obligation to update any of the foregoing or any other forward-looking statements. STAAR nonetheless reserves the right to make such updates from time to time by press release, periodic report or other method of public disclosure without the need for specific reference to this news release. No such update shall be deemed to indicate that other statements not addressed by such update remain correct or create an obligation to provide any other updates.
CONTACT:Investors & Media
Brian Moore
Sr. Director, Investor, Media Relations and Corporate Development
(626) 303-7902, Ext. 3023
bmoore@staar.com
STAAR Surgical Investor Presentation NASDAQ: STAA | January 13, 2020 Exhibit 99.3
Forward Looking Statements All statements in this presentation that are not statements of historical fact are forward-looking statements, including any of the following: statements about the Ophthalmic industry, our business and financial results, any financial projections, including those relating to the plans, strategies, and objectives of management for 2020-2022 and beyond or prospects for achieving such plans, expectations for sales, revenue, or earnings, product safety or effectiveness, total addressable market and our share of the markets in which we compete, the status of our pipeline of ICL products with regulators, including our EDOF lens for Presbyopia and our EVO family of lenses in the U.S., and any statements of assumptions underlying any of the foregoing, including those relating to our product pipeline and market expansion activities. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in the Company’s Annual Report on Form 10-K for the year ended December 28, 2018 under the caption “Risk Factors,” which is on file with the Securities and Exchange Commission and available in the “Investor Information” section of the company’s website under the heading “SEC Filings.” We disclaim any intention or obligation to update or revise any financial projections or forward-looking statement due to new information or events. These statements are based on expectations and assumptions as of the date of this press release 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 the following: global economic conditions; the discretion of regulatory agencies to approve or reject existing, new or improved products, or to require additional actions before approval, or to take enforcement action; potential international trade disputes; and the willingness of surgeons and patients to adopt a new or improved product and procedure. The The Visian ICL with CentraFLOW, now known as EVO Visian ICL, is not yet approved for sale in the United States.
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 happen in the US market. I am opening two new practices in Milwaukee and Minneapolis in January and the ICL is a cornerstone of our business plan. I will not be offering LASIK and will have the first fully intraocular refractive surgery clinic in each location. We are on track to open four additional clinics in major metropolitan areas with the next 24 months. There are significant tailwinds that I believe will drive ICL growth. While the LASIK market has contracted, the desire to be free of glasses has not gone away and there is pent up demand that will fuel ICL growth. The distinction between cataract and refractive surgery is blurring as all intraocular surgeries now have a refractive end point with the expectation of clear spectacle free vision. The ICL is a natural fit for anterior segment surgeons who offer premium IOL options. The future looks bright for the ICL in the US and I anticipate accelerated growth as the EVO models become available.” - John Vukich, MD Chief Medical Officer, Summit Eyecare
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
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 of Uncorrected Refractive Error by Age; Patient Ability to Pay; Proximity to Qualified Surgeon; Willingness to Undergo a Refractive Procedure; and Surgeon Input. Distance Vision / Nearsightedness Target Market: Ages 21-45+ Near Vision / Reading Glasses Target Market: Ages 45-55+ 1.7 Billion Presbyopes 55 Million Presbyopes STAAR’s Opportunity* 1.9 Billion Myopes 35 Million Myopes STAAR’s Opportunity*
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 Ophthalmology. ** Fricke, Global Prevalence of Presbyopia and Vision Impairment from Uncorrected Presbyopia. Eyeglasses $48B Contact Lenses $16B Refractive $6B Number of myopes (millions) Myopia – Now and In 2050* Myopia prevalence (%) Year
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™
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 Protection
Industry Leading Growth 22% CAGR 2017-2019 *Preliminary revenue results as announced on January 13, 2020 for Q4 and fiscal year 2019 not adjusted for constant currency. Calendarization of quarterly revenue anticipated to be approximately 22% (Q1); 27% (Q2); 26% (Q3); 25% (Q4) for fiscal year 2020. Revenue and Growth Y/Y… $ 82.4 $ 90.6 $ 124.0 $ 150.2E* 2016 2017 2018 2019 +7% Growth +10% Growth +37% Growth $ Millions +21% 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.
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
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 (gross proceeds) in August 2018.
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
ICL Global Market Share* * Company Estimates as of October 24, 2019. From < 2% to 6% Est. 2019 Japan 23%
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.
EVO Only Clinics Paradigm Change Consumer Marketing Propels EVO Growth China What’s Going On…
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 Society modified its surgical indication criteria for recommended use of phakic intraocular lenses, such as the EVO Visian ICL, from -6.0 diopters to -3.0 diopters in 2019. Dr. Yoshihiro Kitazawa, Chief Medical Director, Sapia Tower Eye Clinic in Tokyo
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 global partnership model for smaller clinics with Dr. Neuhann of the Eye Clinic at Marienplatz Germany and Spain What’s Going On… Surgeon Support + Strategic Partnerships * Border recommendation moved to -1.0D.
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 OUS surgeons educating U.S. surgeons on ICL business model opportunity Tremendous excitement among U.S. Surgeons Dozens of recently-signed strategic alliance agreements throughout North America Bring Successful OUS Business Model to U.S.
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
* 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 2017 Investor Day and Execution… Promises Made. Promises Kept. GAAP EPS Outlook 2018 - 2020 Annual Revenue Growth of 15 - 20% Stretch Annual ICL Unit Growth of 25%+ Profitability Improvement; Achieve Sustainable Positive EPS within 3-Year Plan Maintain and Improve Cash Flow Achieve $25M Total Cash by YE 2020 Execution 2018 + 2019 YTD* 20% - 37% Annual Revenue Growth 36% - 54% Annual ICL Unit Growth $112.3M Total Cash** FY17 FY18 FY19 YTD ($0.05) $0.11 $0.16 Cash From Operations FY17 FY18 FY19 YTD $2.9M $12.8M $16.0M
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 Clinical Validation and Medical Affairs Excellence thereby Achieving Surgeon Commitment Innovate and Develop a Pipeline of Next Generation Premium Collamer-Based Intraocular Lenses… Monofocal, Presbyopic and Accommodating Deliver Foundations 2022: Assure World Class Supply Integrity and Delivery Performance while Driving Gross Margin Above 80% Continue our Focus on and Commitment to STAAR’s Culture of Quality Delight Shareholders! We have a Passionate Commitment to Deliver Visual Freedom to Patients for an Active and Fulfilling Life Independent of Contact Lenses and Glasses…
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 FLOW AND BALANCE SHEET Strong Cash Flow Continues Balance Sheet Cash Increases Fiscal Year 2020 Emphasis: Patient Awareness Commercialization Clinical Trials Presbyopia Introduction
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 range Increase consumer outreach efforts in key markets Investment in hybrid distribution models will increase growth profiles in critical markets
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 INVESTMENTS Monrovia, Nidau, and Lake Forest (EDOF) Production Clinicals, EVO in the U.S. + EDOF Presbyopia Clinicals ROW Commercial Buildout Digital Marketing Surgeon Support Patient Outreach Financial Outlook Assumptions
2020-2022 Supplemental Use for EVO Family of Lenses Announced CE Mark approval on January 13, 2020; aimed at post-cataract IOL market (28M+ global procedures annually*); adds surgeon option to use EVO family of lenses… As a touch-up for refractive surprise patients; To provide improved range of vision for patients who already have monofocal IOLs (EDOF); or As an alternative to multifocal IOLS, e.g. paired-use of monofocal IOL + EDOF EVO ICL for Presbyopia (EDOF) Currently under regulatory review for approval in CE Mark countries Following approval, potential controlled commercial roll-out by end of Q2’2020 Expands target ICL age range in new ‘Holy Grail’ market of refractive surgery Pre-Loaded Injector for ICL Planned regulatory submission for 2H’2020 U.S. Introduction of EVO Family of Lenses for Myopia Approved study for 300-eyes with six-month follow-up commencing Q1’2020 If/when approved would bring STAAR’s latest family of lenses to the #2 market in the world for refractive surgery Product Pipeline *Market Scope, September 2019.
www.staar.com www.discoverevo.com The Future of Refractive Surgery is Lens-Based... The Time for STAAR is Now