Investor Presentation
June 12, 2024
NASDAQ: STAA
Forward Looking Statements
All statements that are not statements of historical fact are forward-looking statements, including statements about any of the following: any financial projections, anticipated financial results, estimates and outlook (including as to net sales, Adjusted EBITDA, and Adjusted EBITDA per diluted share), plans, strategies, and objectives of management for 2024 and beyond or prospects for achieving such plans, expectations for sales, revenue, margin, expenses or earnings, and any statements of assumptions underlying any of the foregoing, including those relating to financial performance in the upcoming quarter, fiscal year 2024 and beyond.
Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include risks and uncertainties related to global economic conditions, as well as the factors set forth in the Company's Annual Report on Form 10-K for the year ended December 29, 2023 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, www.staar.com, 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 COVID-19; the discretion of regulatory agencies to approve or reject existing, new or improved products, or to require additional actions before or after approval, or to take enforcement action; international conflicts, trade disputes and substantial dependence on demand from Asia; and the willingness of surgeons and patients to adopt a new or improved product and procedure.
We intend to use our website as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Such disclosures will be included on our website in the 'Investor Relations' sections. Accordingly, investors should monitor such portions of our website, in addition to following our presentations, SEC filings and public conference calls and webcasts.
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Non-GAAP Financial Information
To supplement the Company's financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), this presentation and the accompanying tables include certain non-GAAP financial measures, including Adjusted EBITDA. Management uses these non- GAAP financial measures in its evaluation of Company operating performance and believes investors will find them useful in evaluating the Company's operating performance, including cash flow generation, and in analyzing period-to-period financial performance of core business operations and underlying business trends. Non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.
EBITDA is a non-GAAP financial measure, which is calculated by adding interest income and expense, net; provision for income taxes; and depreciation and amortization to net income. In calculating Adjusted EBITDA and Adjusted EBITDA per diluted share, the Company further adjusts for stock-based compensation expense. As stock-based compensation is a non-cash expense that can vary significantly based on the timing, size and nature of awards granted, the Company believes that the exclusion of stock-based compensation expense can assist investors in comparisons of Company operating results with other peer companies because (i) the amount of such expense in any specific period may not directly correlate to the underlying performance of our business operations and (ii) such expense can vary significantly between periods as a result of the timing of grants of new stock- based awards, including inducement grants in connection with hiring. Additionally, the Company believes that excluding stock-based compensation from Adjusted EBITDA and Adjusted EBITDA per diluted share assists management and investors in making meaningful comparisons between the Company's operating performance and the operating performance of other companies that may use different forms of employee compensation or different valuation methodologies for their stock-based compensation. Investors should note that stock-based compensation is a key incentive offered to employees whose efforts contributed to the operating results in the periods presented and are expected to contribute to operating results in future periods. Investors should also note that such expenses will recur in the future.
In the appendix to this presentation, the Company has included a reconciliation of Adjusted EBITDA and Adjusted EBITDA per diluted share to net income and net income per diluted share, the most directly comparable GAAP financial measure. The Company has also provided a reconciliation of forward-looking Adjusted EBITDA and Adjusted EBITDA per diluted share to net income and net income per diluted share. This represents forward- looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward Looking Statements section of this presentation.
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Why Invest?
STAAR Surgical is
Ushering in the Next
Generation of Vision
Correction with EVO ICL™
04
Product / The EVO ICL™ Procedure and Collamer® Material Has Advantages for Surgeons and Patients
3 Million+ |
Sharp, clear | |
COLLAMER | vision Day & |
Reversible
99.4%
Lenses Sold |
200+ Peer-
COLLAGEN + POLYMER | Night 1,2 |
Quick
Lens Implant
Additive /
of EVO patients surveyed would choose EVO again5
Reviewed ICL Clinical Papers
30+ Year
History of
Safety and
Effectiveness
procedure and
recovery
Does not cause
dry eye
syndrome 3,4
Preserves the
Cornea
UV Protection
1) Martínez-Plaza E, López-Miguel A, López-de la Rosa A, et al. Effect of the EVO+ Visian Phakic Implantable Collamer Lens on Visual Performance and Quality of Vision and Life, Am J | |
Ophthalmol 2021;226:117-125. 2) Packer M. Evaluation of the EVO/EVO+ Sphere and Toric Visian ICL: Six month results from the United States Food and Drug Administration clinical trial. | 05 |
Clinical Ophthalmology. 2022;16:1541-53. 3) Ganesh S, Brar S, Pawar A. Matched population comparison of visual outcomes and patient satisfaction between 3 modalities for the correction |
of low to moderate myopic astigmatism. Clin Ophthalmol. 2017;11:1253-1263. 4) Naves J.S, Carracedo G, Cacho-Babillo I, Diadenosine nucleotid measurements as dry-eye score in patients after LASIK and ICL surgery. Presented at American Society of Cataract and Refractive Surgery (ASCRS) 2012. 5) STAAR Survey.
People / We Have Strengthened Our Governance and Leadership
Board of Directors
Arthur Butcher | Stephen C. Farrell |
Aimee S. Weisner | Elizabeth Yeu, MD |
STAAR Corporate Officers
TOM FRINZI
Chair of the Board,
President and CEO
Tom Frinzi | Wei Jiang |
K. Peony Yu, MD | Lilian Zhou, CFA |
WARREN FOUST | PATRICK WILLIAMS |
Chief Operating Officer | Chief Financial Officer |
MAGDA MICHNA, PHD | NATHANIEL SISITSKY |
Chief Clinical, Regulatory | General Counsel and Corporate |
and Medical Affairs Officer | Secretary |
NANCY SABIN | KEITH HOLLIDAY, PHD |
Chief Marketing Officer | Chief Technology Officer |
SCOTT BARNES, MD | |
Chief Medical Officer | 06 |
TAM / The Global Myopia Epidemic Means Our Market Opportunity is Significant
Key Factors with Myopia
Genetic
Predisposition
Today: Every third | 2050: Every other | Normal | Myopia | Environmental |
person in the world | person in the world * | Factors |
M Y O P I A | Billions of People | ||
6.0 | |||
Myopia | High Myopia |
5.0 | 4.9 |
4.1 | |
4.0 | 3.4 |
3.0 | 2.6 |
2.0 |
STAAR EVO ICL's near and long-term market opportunity remains exciting and vast, despite any transient noise (previously COVID and now macroeconomic headwinds associated with a normal business cycle). Myopia is a global pandemic with no known cure.
2.0
1.0
0.0
1.4
2000 | 2010 | 2020 | 2030 | 2040 | 2050 |
*BHVI, adapted from Holden et al. 2016 Ophthalmology. 36% of studies defined high myopia as -6.0D or more. 07
STAAR / Our Sales Outlook Is for a Strong Trajectory of Growth
VISION 2026
3-Year Sales CAGR (Fiscal 2024-2026)
APAC | EMEA | AMERICAS |
15% to 20% | 10% to 15% | 25% to 30% |
China ~20% | U.S. 30% to 50% |
Fiscal 2024 ICL Growth *
APAC | EMEA | AMERICAS |
Sales Opportunities and Hurdles
Pace of EVO ICL adoption down the diopter curve, e.g., increasing utilization of EVO ICL -6D to -8D and above for refractive vision correction.
Country mix (Direct vs. Hybrid/Distributor)
7% | Flat | 10% | Success of U.S. market building initiatives |
China approx. 10% Growth | U.S. Growth of $2M in 2H24 will | Success of initiatives in other markets globally | |
All Other Countries Flat | result in approx. 10% for FY24 | ||
Macroeconomic environment |
* On February 26, 2024, STAAR provided Fiscal 2024 ICL sales growth outlook (Year 1 of 3-Year Plan) and reaffirmed Vision 2026 3-Year Outlook. | 08 |
.
STAAR / We Are Using Our Increasing Capabilities and Financial Strength to Outpace the Industry and Capture Market Share
We are establishing EVO ICL™ as The First Choice for Doctors and Patients Seeking Visual Freedom
ICL Units Refractive Industry Procedures ICL Outperformance **
ICL Grows through | ||||||
54% | 51% | 48% | Transient Macro and | |||
Business Cycle Headwinds | ||||||
38% | ||||||
33% | 33% | ICL unit growth… | ||||
28% | 28% | 26% | ||||
16% | 19% | +26 points above industry / 2023* | ||||
11% | ||||||
10% | ||||||
5% | 5% | |||||
3% | +28 points above industry / 2022* | |||||
(5%) | (7%) | |||||
2018 | 2019 | 2020 | 2021 | 2022 | 2023 |
* Global ICL unit growth vs. Market Scope global refractive industry procedure growth. ** ICL outperformance = Global ICL unit growth less refractive industry procedure growth.
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STAAR / EVO ICL™ is Taking Market Share
Estimates as of January 2, 2024 *
100%
90%
2023
80%
70%
60%
50%
40%
2018
73%
EVO ICL is a unique technology. Our market share capture in Japan, China and South Korea is representative of our market share opportunity in every market in which we operate. In every market we have initially faced a
30% | 23% | |||||
20% | 15% | 17% | ||||
10% | 5% | 8% | 9% | 8% | 2% | |
1% | ||||||
0% | ||||||
Global | Japan | China | South Korea | United States | ||
- Company estimates based on Market Scope, Refractive Surgery Council and survey data as of January 2, 2024, and estimated global refractive procedure volumes in 2023 of approximately 4.1 million.
variety of obstacles to gain share
and add procedures to the refractive market, but we have and continue to work successfully to overcome any obstacles, getting better at doing so over time.
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Disclaimer
STAAR Surgical Company published this content on 12 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 12 June 2024 12:24:07 UTC.