Staar Surgical Co 8-K, filed Jun 7, 2022
Staar Surgical Co (STAA)
About this 8-K
Staar Surgical Co filed this 8-K on June 7, 2022.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 8.01: Other events
- 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
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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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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.
Representatives of STAAR Surgical Company (the “Company”) will give presentations to investors commencing on June 7, 2022. A copy of the slide presentation they will share is furnished as Exhibit 99.1 to this Report and is incorporated herein by this reference.
Item 8.01 Other Events.
On June 7, 2022, the “Company published a press release reporting that more than two million Visian® Implantable Collamer lenses (“ICLs”) have been sold globally, a copy of which is furnished as Exhibit 99.2 to this report and is incorporated herein by this reference.
This information and the information contained in the presentation and press release shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information in Item 7.01 and Item 8.01 of this Current Report, and Exhibits 99.1 and 99.2 are not incorporated by reference into any filings of STAAR made under the Securities Act of 1933, as amended, whether made before or after the date of this Current Report, regardless of any general incorporation language in the filing unless specifically stated so therein.
Item 9.01 Financial Statements and Exhibits
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Exhibit No. |
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Description |
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99.1 |
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99.2 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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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June 7, 2022 |
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/s/ Caren Mason |
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Caren Mason |
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President and Chief Executive Officer |
STAAR Surgical Investor Presentation NASDAQ: STAA | June 2022 Exhibit 99.1
All statements that are not statements of historical fact are forward-looking statements, including statements about any of the following: any financial projections (including sales), plans, strategies, and objectives of management for 2022 or prospects for achieving such plans, expectations for sales, revenue, margin, expenses or earnings, the expected impact of the COVID-19 pandemic and related public health measures (including but not limited to its impact on sales, operations or clinical trials globally), product safety or effectiveness, the status of our pipeline of ICL products with regulators, 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 include risks and uncertainties related to the COVID-19 pandemic and related public health measures, as well as the factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 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 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 the following: global economic conditions; the impact of the COVID-19 pandemic on markets; 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; international trade disputes; and the willingness of surgeons and patients to adopt a new or improved product and procedure. 02 Forward Looking Statements
Who Is STAAR Surgical? Exclusive manufacturer of proprietary EVO Visian® Family of Implantable Collamer® Lenses (EVO ICL) used worldwide to correct refractive error Executing against a rapidly expanding global Total Addressable Market (TAM) of millions of eyes Achieving industry-leading growth via primary and premium EVO ICL positioning, collaborative business model and clinical validation Strong financial performance includes expanding margins, EPS and cash – a rare combination of high growth & GAAP profitability 01 03 02 04 03
Refractive Error is a Global Epidemic * Global prevalence of clinically significant astigmatism (>0.75D), Market Scope, 2019. ** BHVI, adapted from Holden et al. 2016 Ophthalmology. *** Fricke, Global Prevalence of Presbyopia and Vision Impairment from Uncorrected Presbyopia, 2018. 04 75-80% of ages 45-54 are using correction for presbyopia*** Myopia More near work, less time outdoors, cell phones, screen time, gaming, education/studying Astigmatism accompanies myopia in ~ 25% of cases* Distance Vision Presbyopia Progressive age-related condition Near Vision Half of the global population is expected to have myopia by 2050**
The Existing Myopia Market is Millions of Eyes * Market Scope estimates for 2021 published January 2022. One Eye = One Procedure. Procedures rounded to nearest 10,000. R.O.W = Rest of World. Industry reports estimate the global market for refractive procedures will grow from 4 million annually in 2020 to 6.1 million in 2025. ** Company estimate. 05 Annual Global Refractive Procedures* 4.2 M China Latin America India USA R.O.W. W.Europe 1.1M 960K 910K 300K 210K 740K frequent replacement contact lens wearers drop out each year in the U.S. alone** Refractive Contact Lenses Eyeglasses 6 M $6 B $16 B Annual Global Spend** $48 B Opportunity
STAAR’s TAM is Tens of Millions of Eyes * Company estimates of viable market opportunity. Bilaterally, 35 Million Myopes = 70 Million Lenses and 55 Million Presbyopes = 110 Million Lenses. 06 Myopes Myopes Myopia Eyes Presbyopia Eyes Presbyopes Presbyopes Distance Vision (Nearsightedness) Target Market Ages 21-45+ Target Market Ages 45-55+ Near Vision (Reading Glasses) Epidemiological Data STAAR Adjustments to Global Prevalence Patient Ability to Pay Distribution of Uncorrected Refractive Error Proximity to Qualified Surgeon Willingness to Undergo Refractive Procedure Surgeon Input Myopia Presbyopia 1.9 B 35 M 70 M 110 M Global Prevalence STAAR’s Opportunity* 1.7 B STAAR’s TAM* 55 M
An Evolution in Visual Freedom 07 STAAR’S ICL TECHNOLOGY
EVO ICL Technology 08 Natural Crystalline Lens EVO ICL™ Iris A single-piece foldable phakic intraocular lens (IOL) implanted within the posterior chamber of the eye directly behind the iris and in front of the natural crystalline lens, designed to correct refractive error…
Why EVO ICL? Patients and Surgeons Tell Us… 09 Bio-Compatible Additive UV Protection Quality of Vision Eco-Friendly Collamer Material Upgradeable Removable Quiet in the Eye Excellent Night Vision No Dry Eye Syndrome No Capital Equipment Investment
Happy ICL Patients * Packer, The Implantable Collamer Lens with a central port: review of the literature, Clinical Ophthalmology, 2018. 10 2 Million+ ICLs Sold Globally
11 ICL AROUND THE WORLD
China – Increasing Share of #1 Global Market 12 Patient roadshows, in-person and virtually on social media such as WeChat, integral to demand cycle China: the first large market to adopt our model of strategic cooperation in 2016 “Hybrid” model, which has 50+ STAAR employees on the ground in country working in concert with importer, hospitals and clinic customers. Accounts 800+ EVO ICL share of the refractive market grew from approximately 2% in 2015 to milestone 20%+ in 2020…
United States – Executing Playbook as we Launch EVO ICL in #2 Global Market 13 Strategic Imperative Drive U.S. growth by successfully commercializing our market-transforming EVO ICL family of myopia lenses following FDA Approval on March 25, 2022 Build upon foundational work since 2019 to accelerate EVO U.S. surgeon support and utilization & Increase EVO ICL Awareness Sales, Practice Development and Clinical Support Infrastructure Expanded Surgeon Organizations and Society Engagement Strategic Agreements EVO Experience Center Meaningfully increase investment in targeted consumer marketing, digital, and influencer campaigns Artist’s Rendition Over 250 U.S. surgeons trained and certified on EVO ICL as of June 1, which is ahead of prior 200 surgeon 2Q22 target.
Europe – Accelerating a Growth Renaissance Driving growth via Surgeon Support and Strategic Sales & Marketing Investments Increasing distributor-to-hybrid market conversions with goal of accelerating growth, e.g. France, Italy and Benelux Making sales & marketing investments that include broadening influencer and social media consumer initiatives Entering large addressable market for refractive Presbyopia Correction with EVO Viva™ EDOF lens with commercial launch at ESCRS 2022 14 * At surgeon discretion, recommendation moved to -1.0D. ** Market Scope, LLC. STAAR Surgical Global Model 2018 to 2024.
We’re Just Getting Started… * Approximate ICL unit share of 2021 global refractive myopia market. 15 ~ 9% ICL share of global market*
16 STAAR’s Track Record of Strong Financial Performance
ICL Unit Growth Significantly Exceeds Refractive Industry * Market Scope, January 2019-2022. 17
ICL Unit Growth Drives… Industry Leading Net Sales Growth ~ +25% CAGR * Initial sales outlook provided prior to COVID on January 13, 2020, was for sales mid-point of $177 million or +18% Y/Y Growth for 2020. CAGR of 26% for 2017-2021 and 24% for 2019-2021. 2022 Outlook initially provided January 10, 2022. 18 $295 Million +28% Growth 2022 Outlook
* 2019 Includes $0.07 GILTI tax benefit. 19 Operating Margin Cash on Balance Sheet - Quarter-End GAAP EPS* Cash from Operations $ Millions STAAR’s Expanding Margins, EPS and Cash
Recent Success and Strong Outlook First Quarter 2022 Results Reported May 4, 2022 Focus remains on advancing our strong growth trajectory for EVO ICL lenses Drive surgeon engagement and consumer-patient awareness Net sales outlook of ~ $295 million for fiscal 2022, subject to no unforeseen impact from COVID on our business, represents strong 28% Y/Y sales growth Net Sales Growth Y/Y to $63.2 Million Global ICL Unit Growth Y/Y 20 25% 29% STAAR is one of just a few U.S. publicly traded SMID-Cap Medical Technology companies with forecasted consensus annual sales growth exceeding 20% Y/Y and positive GAAP earnings Fiscal Year 2022 Outlook
We invite you to visit STAAR’s investor website for clinical papers, examples of global consumer marketing and much more at investors.staar.com www.staar.com www.discoverevo.com
Exhibit 99.2
STAAR Surgical Celebrates Two Million Lens Milestone for Implantable Collamer® Lens (ICL)
Milestone Follows U.S. FDA Approval of EVO Visian® ICL in March
EVO Offers Visual Freedom from Glasses and Contact Lenses
LAKE FOREST, CA, June 7, 2022 --- STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, today announced that more than two million Visian® Implantable Collamer lenses (“ICLs”) have been sold globally, including more than one and a half million of the company’s latest generation of implantable lenses – EVO Visian® ICLs (“EVO”). New to the U.S. market, EVO is available in more than 75 countries around the world.
“As we celebrate the two million lens milestone for Visian® ICL, we extend our sincere appreciation to our surgeon and clinical partners embracing our lens-based vision correction technologies and their patients who have chosen ICL to break free from the hassles of glasses and frequent replacement contact lenses,” said Caren Mason, President and CEO of STAAR Surgical. “In April 2019 we announced achievement of the first one million ICL lenses sold, and today, just about three years later, we are celebrating two million total ICLs sold. This most recent milestone follows the initial successful stages of commercialization of our EVO lenses in the US. Globally, our commitment to leading a lens-based future for refractive vision correction and achieving high levels of growth, led by EVO, will be propelled by our lenses’ clinical validation, a myriad of premium benefits associated with our lenses, and the many happy ICL patients enjoying improved quality of life who state they would have the procedure again.1”
The EVO Visian ICL is a family of phakic intraocular lenses (phakic means the natural crystalline lens is not removed) designed to correct for a wide range of vision correction needs including myopia (nearsightedness) and astigmatism. Myopia is predicted to impact 50% of the world’s population by the year 2050.2
1 99.4% of EVO patients would have the EVO ICL procedure again. Packer, The Implantable Collamer Lens with a central port: review of the literature, Clinical Ophthalmology, 2018.
2 Ophthalmology 2016;123:1036-1042 © 2016 by the American Academy of Ophthalmology.
About STAAR Surgical
STAAR, which has been dedicated solely to ophthalmic surgery for over 40 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 2,000,000 Visian® ICLs have been sold to date and STAAR markets these lenses in over 75 countries. To learn more about the ICL and important safety information 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.
CONTACT:Investors
Brian Moore
Vice President, Investor, Media Relations and Corporate Development
(626) 303-7902, Ext. 3023
bmoore@staar.com
Media
Jen Jones
Gold PR | Social Media
(310) 918-4313
jjones@goldpr.com
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