8-K
Staar Surgical Co (STAA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): October 30, 2024
STAAR Surgical Company
(Exact Name of Registrant as Specified in Charter)
| Delaware | 0-11634 | 95-3797439 |
|---|---|---|
| (State or Other Jurisdiction<br><br>of Incorporation) | (Commission File Number) | (IRS Employer<br><br>Identification No.) |
| 25510 Commercentre Drive<br><br>Lake Forest, California | 92630 | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s Telephone Number, Including Area Code: 626-303-7902
Not Applicable
(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):
| ☐ | Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | 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:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common | STAA | NASDAQ |
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 2.02 Results of Operations and Financial Condition.
On October 30, 2024, STAAR Surgical Company (the “Company”) published a press release reporting its financial results for the quarter ended September 27, 2024, a copy of which is furnished as Exhibit 99.1 to this report and is incorporated herein by this reference.
Item 7.01 Regulation FD Disclosure.
During a conference call and webcast scheduled to be held at 4:30 p.m. Eastern / 1:30 p.m. Pacific on October 30, 2024, the Company’s Chair of the Board, President and Chief Executive Officer, and the Company's Chief Financial Officer will discuss the Company’s results for the quarter ended September 27, 2024 and the Company’s outlook for fiscal year 2024. The Company’s slide presentation for the conference call and webcast is furnished as Exhibit 99.2 to this Current Report.
The information furnished herewith pursuant to Items 2.02 and 7.01 of this Current Report, including Exhibits 99.1 and 99.2, 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 Items 2.02 and 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
| Exhibit No. | Description |
|---|---|
| 99.1 | Press release of the Company dated October 30, 2024. |
| 99.2 | Slide presentation of the Company dated October 30, 2024. |
| 104 | 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.
| STAAR Surgical Company | ||
|---|---|---|
| October 30, 2024 | By: | /s/ Tom Frinzi |
| Thomas G. Frinzi | ||
| President and Chief Executive Officer |
EX-99.1
Exhibit 99.1
STAAR Surgical Reports Third Quarter 2024 Results
Net Sales Up 10% to $88.6 Million Driven by Growth in All Regions
Americas Up 14%, EMEA Up 12% and APAC Up 9%
Market Building Initiatives Drive EVO ICL™ Uptake and Reinforce Opportunity
LAKE FOREST, CA, October 30, 2024 --- STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of the EVO family of Implantable Collamer® Lenses (EVO ICL™) for myopia, astigmatism and presbyopia, today reported financial results for the third quarter ended September 27, 2024.
Third Quarter 2024 Overview
- Net sales of $88.6 million, up 10% from prior year quarter
- ICL sales of $89.1 million, up 10% from prior year quarter
- Gross margin of 77.3% as compared to 79.2% year ago
- Net income of $10.0 million or $0.20 per share, up from $4.8 million or $0.10 per share year ago
- Adjusted EBITDA of $16.2 million or $0.33 per share as compared to $16.5 million or $0.33 per share year ago
- $236.0 million of cash, cash equivalents and investments available for sale as of September 27, 2024
"In the third quarter, we achieved double-digit sales growth against a macroeconomic environment that softened in the second half of the quarter, particularly in China," said Tom Frinzi, President and CEO of STAAR Surgical. "STAAR is well positioned to navigate through the current market dynamics, which we believe are transitory. Looking ahead, we are encouraged by the recent shift in fiscal policy and announced stimulus in China and will continue to closely monitor the potential impact on our near to midterm growth outlook.”
Mr. Frinzi concluded, “Our focus on customer engagement and market expansion continues to yield solid results, helping drive industry-leading growth and market share gains. As our surgeon customers perform more EVO procedures, they are increasingly using our technology for moderate myopia, which underscores EVO ICL as the treatment choice for -6D and above and expands our total addressable market.”
Third Quarter 2024 Financial Results
Net sales were $88.6 million for the third quarter of 2024, up 10% from $80.3 million reported in the prior year quarter. This sales increase was driven by ICL sales growth of $8.0 million, up 10%, and unit growth of 6% from the prior year period. Other Product sales declined $0.2 million from the prior year period. Changes in currency, primarily the Japanese Yen, negatively impacted reported total net sales by $0.3 million for the third quarter of 2024.
Gross profit margin for the third quarter of 2024 was 77.3% of net sales as compared to the prior year quarter of 79.2% of net sales. Gross margin in the third quarter was lower primarily due to reduced unit production that resulted in less absorption of fixed overhead.
Operating expenses for the third quarter of 2024 were $62.8 million, up from the prior year quarter of $57.3 million. General and administrative expenses were $21.7 million, up from $19.3 million in the prior year quarter, driven primarily by increased facility costs and compensation-related expenses. Selling and marketing expenses were
$26.6 million – consistent with the prior year quarter. Research and development expenses were $14.5 million, up from the prior year quarter of $11.5 million, primarily due to purchases of in-process research and development, as well as compensation-related expenses, which were partially offset by lower clinical trial costs.
Operating income for the third quarter of 2024 was $5.7 million or 6.4% of net sales as compared to operating income of $6.3 million or 7.8% of net sales for the third quarter of 2023.
Net income for the third quarter of 2024 was $10.0 million or $0.20 income per share, up from $4.8 million or $0.10 income per share for the prior year quarter. The increase in net income was primarily attributable to a gain on foreign currency transactions.
As of September 27, 2024, cash, cash equivalents and investments available for sale totaled $236.0 million, up from $232.4 million on December 29, 2023.
Outlook
The Company maintained its prior outlook for fiscal year 2024 net sales and Adjusted EBITDA.
- Net sales of $340 million to $345 million.
- Adjusted EBITDA of approximately $42 million and Adjusted EBITDA per diluted share of approximately $0.80.
The outlook above contemplates EVO ICL sales growth of 17% in the Americas (prior outlook was 15%) including 20% in the U.S. (prior outlook was 25%); EMEA sales growth of 10% (prior outlook was 6%); and APAC sales growth of 4% (prior outlook was 7%), including approximately 2% growth in China (prior outlook was 10%).
Earnings Webcast
The Company will host an earnings webcast today, Wednesday, October 30 at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and operational progress. To access the webcast please use the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=fmU0YbKB
The live webcast, earnings webcast presentation and an archived version of the webcast can be accessed from the investor relations section of the STAAR website at www.staar.com.
Use of Non-GAAP Financial Measures
To supplement the Company’s financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), this press release 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.
The Company also presents certain financial information on a constant currency basis, which is intended to exclude the effects of foreign currency fluctuations. The Company conducts a significant part of its activities outside the U.S. It receives sales revenue and pays expenses principally in U.S. dollars, Swiss francs, Japanese yen and euros. The exchange rates between dollars and non-U.S. currencies can fluctuate greatly and can have a significant effect on the Company’s results when reported in U.S. dollars. In order to compare the Company's performance from period to period without the effect of currency, the Company will apply the same average exchange rate applicable in the prior period, or the “constant currency” rate to sales or expenses in the current period as well.
In the tables provided below, 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, as well as supplemental financial information with net sales expressed in constant currency. 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 Safe Harbor section of this press release.
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. 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 ICL™ product line. More than 3,000,000 ICLs have been sold to date and STAAR markets these lenses in over 75 countries. To learn more about the ICL go to: EVOICL.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.
Safe Harbor
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 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 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 press releases, SEC filings and public conference calls and webcasts.
| CONTACT: | Investors & Media | |||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brian Moore | ||||||||||||||||||||||||||||||||||||||||||||
| Vice President, Investor Relations and Corporate Development | ||||||||||||||||||||||||||||||||||||||||||||
| 626-303-7902, Ext. 3023 | ||||||||||||||||||||||||||||||||||||||||||||
| bmoore@staar.com | ||||||||||||||||||||||||||||||||||||||||||||
| Investors – Asia | ||||||||||||||||||||||||||||||||||||||||||||
| --- | ||||||||||||||||||||||||||||||||||||||||||||
| Niko Liu, CFA | ||||||||||||||||||||||||||||||||||||||||||||
| Director, Investor Relations and Corporate Development – Asia | ||||||||||||||||||||||||||||||||||||||||||||
| +852-6092-5076 | ||||||||||||||||||||||||||||||||||||||||||||
| nliu@staar.com | ||||||||||||||||||||||||||||||||||||||||||||
| Consolidated Balance Sheets | ||||||||||||||||||||||||||||||||||||||||||||
| --- | --- | --- | --- | --- | --- | --- | ||||||||||||||||||||||||||||||||||||||
| (in 000's) | ||||||||||||||||||||||||||||||||||||||||||||
| Unaudited | ||||||||||||||||||||||||||||||||||||||||||||
| ASSETS | September 27, 2024 | December 29, 2023 | ||||||||||||||||||||||||||||||||||||||||||
| Current assets: | ||||||||||||||||||||||||||||||||||||||||||||
| Cash and cash equivalents | $ | 164,003 | $ | 183,038 | ||||||||||||||||||||||||||||||||||||||||
| Investments available for sale | 71,955 | 37,688 | ||||||||||||||||||||||||||||||||||||||||||
| Accounts receivable trade, net | 104,510 | 94,704 | ||||||||||||||||||||||||||||||||||||||||||
| Inventories, net | 40,361 | 35,130 | ||||||||||||||||||||||||||||||||||||||||||
| Prepayments, deposits, and other current assets | 16,277 | 14,709 | ||||||||||||||||||||||||||||||||||||||||||
| Total current assets | 397,106 | 365,269 | ||||||||||||||||||||||||||||||||||||||||||
| Investments available for sale | - | 11,703 | ||||||||||||||||||||||||||||||||||||||||||
| Property, plant, and equipment, net | 81,580 | 66,835 | ||||||||||||||||||||||||||||||||||||||||||
| Finance lease right-of-use assets, net | 73 | 183 | ||||||||||||||||||||||||||||||||||||||||||
| Operating lease right-of-use assets, net | 37,897 | 34,387 | ||||||||||||||||||||||||||||||||||||||||||
| Goodwill | 1,786 | 1,786 | ||||||||||||||||||||||||||||||||||||||||||
| Deferred income taxes | 5,324 | 5,190 | ||||||||||||||||||||||||||||||||||||||||||
| Other assets | 13,824 | 3,339 | ||||||||||||||||||||||||||||||||||||||||||
| Total assets | $ | 537,590 | $ | 488,692 | ||||||||||||||||||||||||||||||||||||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||||||||||||||||||||||||||||||||||||
| Current liabilities: | ||||||||||||||||||||||||||||||||||||||||||||
| Accounts payable | $ | 14,694 | $ | 13,557 | ||||||||||||||||||||||||||||||||||||||||
| Obligations under finance leases | 84 | 165 | ||||||||||||||||||||||||||||||||||||||||||
| Obligations under operating leases | 4,531 | 4,202 | ||||||||||||||||||||||||||||||||||||||||||
| Allowance for sales returns | 8,124 | 6,174 | ||||||||||||||||||||||||||||||||||||||||||
| Other current liabilities | 38,908 | 40,938 | ||||||||||||||||||||||||||||||||||||||||||
| Total current liabilities | 66,341 | 65,036 | ||||||||||||||||||||||||||||||||||||||||||
| Obligations under finance leases | - | 42 | ||||||||||||||||||||||||||||||||||||||||||
| Obligations under operating leases | 35,385 | 31,425 | ||||||||||||||||||||||||||||||||||||||||||
| Deferred income taxes | 1,056 | 1,077 | ||||||||||||||||||||||||||||||||||||||||||
| Asset retirement obligations | 127 | 103 | ||||||||||||||||||||||||||||||||||||||||||
| Pension liability | 6,559 | 5,055 | ||||||||||||||||||||||||||||||||||||||||||
| Total liabilities | 109,468 | 102,738 | ||||||||||||||||||||||||||||||||||||||||||
| Stockholders' equity: | ||||||||||||||||||||||||||||||||||||||||||||
| Common stock | 493 | 488 | ||||||||||||||||||||||||||||||||||||||||||
| Additional paid-in capital | 466,579 | 436,947 | ||||||||||||||||||||||||||||||||||||||||||
| Accumulated other comprehensive loss | (5,602 | ) | (4,113 | ) | ||||||||||||||||||||||||||||||||||||||||
| Accumulated deficit | (33,348 | ) | (47,368 | ) | ||||||||||||||||||||||||||||||||||||||||
| Total stockholders' equity | 428,122 | 385,954 | ||||||||||||||||||||||||||||||||||||||||||
| Total liabilities and stockholders' equity | $ | 537,590 | $ | 488,692 | ||||||||||||||||||||||||||||||||||||||||
| Consolidated Statements of Income | ||||||||||||||||||||||||||||||||||||||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | ||||||||||
| (in 000's except for per share data) | ||||||||||||||||||||||||||||||||||||||||||||
| Unaudited | ||||||||||||||||||||||||||||||||||||||||||||
| Three Months Ended | Year to Date | |||||||||||||||||||||||||||||||||||||||||||
| % of Sales | September 27, 2024 | % of Sales | September 29, 2023 | Fav (Unfav) Amount | % | % of Sales | September 27, 2024 | % of Sales | September 29, 2023 | Fav (Unfav) Amount | % | |||||||||||||||||||||||||||||||||
| Net sales | 100.0 | % | $ | 88,590 | 100.0 | % | $ | 80,308 | $ | 8,282 | 10.3 | % | 100.0 | % | $ | 264,951 | 100.0 | % | $ | 246,142 | $ | 18,809 | 7.6 | % | ||||||||||||||||||||
| Cost of sales | 22.7 | % | 20,103 | 20.8 | % | 16,670 | (3,433 | ) | (20.6 | )% | 21.5 | % | 57,017 | 22.0 | % | 54,216 | (2,801 | ) | (5.2 | )% | ||||||||||||||||||||||||
| Gross profit | 77.3 | % | 68,487 | 79.2 | % | 63,638 | 4,849 | 7.6 | % | 78.5 | % | 207,934 | 78.0 | % | 191,926 | 16,008 | 8.3 | % | ||||||||||||||||||||||||||
| Selling, general and administrative expenses: | ||||||||||||||||||||||||||||||||||||||||||||
| General and administrative | 24.4 | % | 21,685 | 24.0 | % | 19,266 | (2,419 | ) | (12.6 | )% | 25.9 | % | 68,554 | 22.6 | % | 55,461 | (13,093 | ) | (23.6 | )% | ||||||||||||||||||||||||
| Selling and marketing | 30.1 | % | 26,623 | 33.1 | % | 26,607 | (16 | ) | (0.1 | )% | 31.0 | % | 82,150 | 34.6 | % | 85,238 | 3,088 | 3.6 | % | |||||||||||||||||||||||||
| Research and development | 16.4 | % | 14,497 | 14.3 | % | 11,470 | (3,027 | ) | (26.4 | )% | 15.8 | % | 41,931 | 13.6 | % | 33,535 | (8,396 | ) | (25.0 | )% | ||||||||||||||||||||||||
| Total selling, general, and administrative expenses | 70.9 | % | 62,805 | 71.4 | % | 57,343 | (5,462 | ) | (9.5 | )% | 72.7 | % | 192,635 | 70.8 | % | 174,234 | (18,401 | ) | (10.6 | )% | ||||||||||||||||||||||||
| Operating income | 6.4 | % | 5,682 | 7.8 | % | 6,295 | (613 | ) | (9.7 | )% | 5.8 | % | 15,299 | 7.2 | % | 17,692 | (2,393 | ) | (13.5 | )% | ||||||||||||||||||||||||
| Other income (expense): | ||||||||||||||||||||||||||||||||||||||||||||
| Interest income, net | 1.6 | % | 1,407 | 2.1 | % | 1,690 | (283 | ) | (16.7 | )% | 1.6 | % | 4,358 | 2.1 | % | 5,287 | (929 | ) | (17.6 | )% | ||||||||||||||||||||||||
| Gain (loss) on foreign currency transactions | 6.7 | % | 5,931 | -1.7 | % | (1,384 | ) | 7,315 | 528.5 | % | 0.2 | % | 585 | -1.3 | % | (3,240 | ) | 3,825 | 118.1 | % | ||||||||||||||||||||||||
| Royalty income | 0.0 | % | - | 0.1 | % | 74 | (74 | ) | (100.0 | )% | 0.2 | % | 508 | 0.0 | % | 74 | 434 | 586.5 | % | |||||||||||||||||||||||||
| Other income, net | 0.2 | % | 139 | 0.1 | % | 71 | 68 | 95.8 | % | 0.2 | % | 532 | 0.1 | % | 144 | 388 | 269.4 | % | ||||||||||||||||||||||||||
| Total other income, net | 8.5 | % | 7,477 | 0.6 | % | 451 | 7,026 | 1557.9 | % | 2.2 | % | 5,983 | 0.9 | % | 2,265 | 3,718 | 164.2 | % | ||||||||||||||||||||||||||
| Income before provision for income taxes | 14.9 | % | 13,159 | 8.4 | % | 6,746 | 6,413 | 95.1 | % | 8.0 | % | 21,282 | 8.1 | % | 19,957 | 1,325 | 6.6 | % | ||||||||||||||||||||||||||
| Provision for income taxes | 3.6 | % | 3,179 | 2.4 | % | 1,929 | (1,250 | ) | (64.8 | )% | 2.7 | % | 7,262 | 2.6 | % | 6,366 | (896 | ) | (14.1 | )% | ||||||||||||||||||||||||
| Net income | 11.3 | % | 9,980 | 6.0 | % | 4,817 | 5,163 | 107.2 | % | 5.3 | % | 14,020 | 5.5 | % | 13,591 | 429 | 3.2 | % | ||||||||||||||||||||||||||
| Net income per share - basic | 0.20 | 0.10 | 0.29 | 0.28 | ||||||||||||||||||||||||||||||||||||||||
| Net income per share - diluted | 0.20 | 0.10 | 0.28 | 0.27 | ||||||||||||||||||||||||||||||||||||||||
| Weighted average shares outstanding - basic | 49,199 | 48,613 | 49,078 | 48,426 | ||||||||||||||||||||||||||||||||||||||||
| Weighted average shares outstanding - diluted | 49,731 | 49,370 | 49,614 | 49,494 | ||||||||||||||||||||||||||||||||||||||||
| Consolidated Statements of Cash Flows | ||||||||||||||||||||||||||||||||||||||||||||
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| (in 000's) | ||||||||||||||||||||||||||||||||||||||||||||
| Unaudited | ||||||||||||||||||||||||||||||||||||||||||||
| Three Months Ended | Year to Date | |||||||||||||||||||||||||||||||||||||||||||
| September 27, 2024 | September 29, 2023 | September 27, 2024 | September 29, 2023 | |||||||||||||||||||||||||||||||||||||||||
| Cash flows from operating activities: | ||||||||||||||||||||||||||||||||||||||||||||
| Net income | $ | 9,980 | $ | 4,817 | $ | 14,020 | $ | 13,591 | ||||||||||||||||||||||||||||||||||||
| Adjustments to reconcile net income to net cash provided by (used in) operating activities: | ||||||||||||||||||||||||||||||||||||||||||||
| Depreciation of property and equipment | 1,757 | 1,345 | 4,516 | 3,743 | ||||||||||||||||||||||||||||||||||||||||
| Amortization of long-lived intangibles | - | (2 | ) | - | 169 | |||||||||||||||||||||||||||||||||||||||
| Accretion/Amortization of investments available for sale | (124 | ) | (348 | ) | (410 | ) | (2,172 | ) | ||||||||||||||||||||||||||||||||||||
| Deferred income taxes | (13 | ) | (10 | ) | 47 | 65 | ||||||||||||||||||||||||||||||||||||||
| Change in net pension liability | (16 | ) | (139 | ) | (162 | ) | (766 | ) | ||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | 7,160 | 8,846 | 22,541 | 23,334 | ||||||||||||||||||||||||||||||||||||||||
| Change in asset retirement obligation | 4 | 3 | 24 | (104 | ) | |||||||||||||||||||||||||||||||||||||||
| Loss on disposal of property and equipment | 1,642 | 17 | 1,668 | 41 | ||||||||||||||||||||||||||||||||||||||||
| Provision for sales returns and bad debts | 868 | 921 | 1,947 | 1,925 | ||||||||||||||||||||||||||||||||||||||||
| Inventory provision | 849 | 460 | 1,873 | 4,090 | ||||||||||||||||||||||||||||||||||||||||
| Changes in working capital: | ||||||||||||||||||||||||||||||||||||||||||||
| Accounts receivable | (10,139 | ) | (18,092 | ) | (9,703 | ) | (50,436 | ) | ||||||||||||||||||||||||||||||||||||
| Inventories | (1,091 | ) | (5,593 | ) | (5,962 | ) | (9,975 | ) | ||||||||||||||||||||||||||||||||||||
| Prepayments, deposits and other assets | (5,152 | ) | (919 | ) | (12,237 | ) | (3,584 | ) | ||||||||||||||||||||||||||||||||||||
| Accounts payable | (5,649 | ) | (1,819 | ) | (2,031 | ) | (3,266 | ) | ||||||||||||||||||||||||||||||||||||
| Other current liabilities | 3,740 | 4,538 | (1,048 | ) | 5,970 | |||||||||||||||||||||||||||||||||||||||
| Net cash provided by (used in) operating activities | 3,816 | (5,975 | ) | 15,083 | (17,375 | ) | ||||||||||||||||||||||||||||||||||||||
| Cash flows from investing activities: | ||||||||||||||||||||||||||||||||||||||||||||
| Acquisition of property and equipment | (6,231 | ) | (9,185 | ) | (17,669 | ) | (15,100 | ) | ||||||||||||||||||||||||||||||||||||
| Purchase of investments available for sale | (40,945 | ) | (9,712 | ) | (61,194 | ) | (52,314 | ) | ||||||||||||||||||||||||||||||||||||
| Proceeds from sale or maturity of investments available for sale | 11,935 | 50,737 | 39,141 | 119,359 | ||||||||||||||||||||||||||||||||||||||||
| Net provided by (used in) investing activities | (35,241 | ) | 31,840 | (39,722 | ) | 51,945 | ||||||||||||||||||||||||||||||||||||||
| Cash flows from financing activities: | ||||||||||||||||||||||||||||||||||||||||||||
| Repayment of finance lease obligations | (42 | ) | (39 | ) | (124 | ) | (121 | ) | ||||||||||||||||||||||||||||||||||||
| Repurchase of employee common stock for taxes withheld | - | (112 | ) | (1,396 | ) | (2,096 | ) | |||||||||||||||||||||||||||||||||||||
| Proceeds from vested restricted stock and exercise of stock options | 1,657 | 7,258 | 7,354 | 9,265 | ||||||||||||||||||||||||||||||||||||||||
| Net cash provided by financing activities | 1,615 | 7,107 | 5,834 | 7,048 | ||||||||||||||||||||||||||||||||||||||||
| Effect of exchange rate changes on cash and cash equivalents | 1,037 | (235 | ) | (230 | ) | (666 | ) | |||||||||||||||||||||||||||||||||||||
| Increase (decrease) in cash and cash equivalents | (28,773 | ) | 32,737 | (19,035 | ) | 40,952 | ||||||||||||||||||||||||||||||||||||||
| Cash and cash equivalents, at beginning of the period | 192,776 | 94,695 | 183,038 | 86,480 | ||||||||||||||||||||||||||||||||||||||||
| Cash and cash equivalents, at end of the period | $ | 164,003 | $ | 127,432 | $ | 164,003 | $ | 127,432 | ||||||||||||||||||||||||||||||||||||
| Reconciliation of Non-GAAP Financial Measure | ||||||||||||||||||||||||||||||||||||||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Net Income to Adjusted EBITDA | ||||||||||||||||||||||||||||||||||||||||||||
| (in 000's except for per share data) | ||||||||||||||||||||||||||||||||||||||||||||
| Unaudited | ||||||||||||||||||||||||||||||||||||||||||||
| Q1-22 | Q2-22 | Q3-22 | Q4-22 | 2022 | Q1-23 | Q2-23 | Q3-23 | Q4-23 | 2023 | Q1-24 | Q2-24 | Q3-24 | 2024 Outlook(2) | |||||||||||||||||||||||||||||||
| Net income (loss) - (as reported) | 27,511 | $ | 9,602 | $ | 13,038 | $ | 10,262 | $ | 6,763 | $ | 39,665 | $ | 2,710 | $ | 6,064 | $ | 4,817 | $ | 7,756 | $ | 21,347 | $ | (3,339 | ) | $ | 7,379 | $ | 9,980 | $ | 3,800 | ||||||||||||||
| Provision (benefit) for income taxes | 3,793 | 1,925 | 2,431 | 2,315 | (784 | ) | 5,887 | 2,009 | 2,428 | 1,929 | 5,983 | 12,349 | 1,128 | 2,955 | 3,179 | 7,600 | ||||||||||||||||||||||||||||
| Other (income) expense, net | 2,035 | 586 | 1,551 | 1,128 | (5,015 | ) | (1,750 | ) | (1,919 | ) | 105 | (451 | ) | (3,334 | ) | (5,599 | ) | (70 | ) | 1,564 | (7,477 | ) | (7,500 | ) | ||||||||||||||||||||
| Depreciation | 3,608 | 994 | 1,030 | 1,077 | 1,380 | 4,481 | 1,113 | 1,285 | 1,345 | 1,368 | 5,111 | 1,237 | 1,522 | 1,757 | 6,000 | |||||||||||||||||||||||||||||
| (Gain) loss on disposal of property plant and equipment(3) | 2 | - | - | - | 65 | 65 | - | 24 | 17 | 32 | 73 | - | 26 | 1,642 | 1,700 | |||||||||||||||||||||||||||||
| Amortization of intangible assets | 34 | 8 | 7 | 7 | 6 | 28 | 7 | 10 | (2 | ) | (2 | ) | 13 | - | - | - | - | |||||||||||||||||||||||||||
| Stock-based compensation | 14,605 | 3,894 | 5,754 | 5,727 | 4,996 | 20,371 | 6,065 | 8,423 | 8,846 | 182 | 23,516 | 6,339 | 9,042 | 7,160 | 30,200 | |||||||||||||||||||||||||||||
| Adjusted EBITDA | 51,588 | $ | 17,009 | $ | 23,811 | $ | 20,516 | $ | 7,411 | $ | 68,747 | $ | 9,985 | $ | 18,339 | $ | 16,501 | $ | 11,985 | $ | 56,810 | $ | 5,295 | $ | 22,488 | $ | 16,241 | $ | 41,800 | |||||||||||||||
| Adjusted EBITDA as a % of Revenue | 22.4 | % | 26.9 | % | 29.4 | % | 27.0 | % | 11.6 | % | 24.2 | % | 13.6 | % | 19.9 | % | 20.6 | % | 15.7 | % | 17.6 | % | 6.8 | % | 22.7 | % | 18.3 | % | 12.2 | % | ||||||||||||||
| Net income (loss) per share, diluted - (as reported) | 0.56 | $ | 0.19 | $ | 0.26 | $ | 0.21 | $ | 0.14 | $ | 0.80 | $ | 0.05 | $ | 0.12 | $ | 0.10 | $ | 0.16 | $ | 0.43 | $ | (0.07 | ) | $ | 0.15 | $ | 0.20 | $ | 0.07 | ||||||||||||||
| Provision (benefit) for income taxes | 0.08 | 0.04 | 0.05 | 0.05 | (0.02 | ) | 0.12 | 0.04 | 0.05 | 0.04 | 0.12 | 0.25 | 0.02 | 0.06 | 0.06 | 0.15 | ||||||||||||||||||||||||||||
| Other (income) expense, net | 0.04 | 0.01 | 0.03 | 0.02 | (0.10 | ) | (0.04 | ) | (0.04 | ) | - | (0.01 | ) | (0.07 | ) | (0.11 | ) | - | 0.03 | (0.15 | ) | (0.14 | ) | |||||||||||||||||||||
| Depreciation | 0.07 | 0.02 | 0.02 | 0.02 | 0.03 | 0.09 | 0.02 | 0.03 | 0.03 | 0.03 | 0.10 | 0.03 | 0.03 | 0.04 | 0.12 | |||||||||||||||||||||||||||||
| (Gain) loss on disposal of property plant and equipment | - | - | - | - | - | - | - | - | - | - | - | - | - | 0.03 | 0.03 | |||||||||||||||||||||||||||||
| Amortization of intangible assets | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||
| Stock-based compensation | 0.30 | 0.08 | 0.12 | 0.12 | 0.10 | 0.41 | 0.12 | 0.17 | 0.18 | - | 0.48 | 0.13 | 0.18 | 0.14 | 0.58 | |||||||||||||||||||||||||||||
| Adjusted EBITDA per share, diluted(1) | 1.04 | $ | 0.35 | $ | 0.48 | $ | 0.41 | $ | 0.15 | $ | 1.39 | $ | 0.20 | $ | 0.37 | $ | 0.33 | $ | 0.24 | $ | 1.15 | $ | 0.11 | $ | 0.45 | $ | 0.33 | $ | 0.80 | |||||||||||||||
| Weighted average shares outstanding - Diluted | 49,456 | 49,288 | 49,223 | 49,549 | 49,389 | 49,380 | 49,500 | 49,516 | 49,370 | 49,242 | 49,427 | 48,907 | 49,811 | 49,731 | 52,000 | |||||||||||||||||||||||||||||
| (1) Adjusted EBITDA per diluted share may not add due to rounding | ||||||||||||||||||||||||||||||||||||||||||||
| (2) 2024 Adjusted EBITDA Outlook line items are all approximations and assumes breakeven Net Income | ||||||||||||||||||||||||||||||||||||||||||||
| (3) The Q3-2024 non cash write-off of 1.6M was related to the former EVO Experience Center |
All values are in US Dollars.
| ICL Sales by Geography | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (in 000's) | |||||||||||||||||||||||||||
| Unaudited | |||||||||||||||||||||||||||
| Fiscal Year | Three Months Ended | ||||||||||||||||||||||||||
| ICL Sales by Region(5) | 2021 | 2022 | 2023 | June 30, 2023 | September 29, 2023 | December 29, 2023 | March 29, 2024 | June 28, 2024 | September 27, 2024 | ||||||||||||||||||
| Americas(1) | $ | 14,054 | $ | 20,114 | $ | 22,233 | $ | 5,954 | $ | 5,449 | $ | 5,264 | $ | 6,260 | $ | 6,794 | $ | 6,187 | |||||||||
| EMEA(2) | 37,343 | 36,715 | 39,318 | 9,782 | 9,253 | 10,103 | 11,299 | 10,727 | 10,333 | ||||||||||||||||||
| APAC(3) | 161,508 | 212,883 | 257,876 | 77,376 | 66,367 | 59,254 | 59,592 | 81,844 | 72,581 | ||||||||||||||||||
| Global ICL Sales | $ | 212,905 | $ | 269,712 | $ | 319,427 | $ | 93,112 | $ | 81,069 | $ | 74,621 | $ | 77,151 | $ | 99,365 | $ | 89,101 | |||||||||
| Global ICL Sales Growth | 51 | % | 27 | % | 18 | % | 19 | % | 13 | % | 22 | % | 9 | % | 7 | % | 10 | % | |||||||||
| Americas ICL Sales Growth | 59 | % | 43 | % | 11 | % | 12 | % | 5 | % | (8 | )% | 12 | % | 14 | % | 14 | % | |||||||||
| EMEA ICL Sales Growth | 45 | % | (2 | )% | 7 | % | (11 | )% | 14 | % | 18 | % | 11 | % | 10 | % | 12 | % | |||||||||
| APAC ICL Sales Growth | 51 | % | 32 | % | 21 | % | 26 | % | 13 | % | 26 | % | 9 | % | 6 | % | 9 | % | |||||||||
| Global ICL Unit Growth | 48 | % | 33 | % | 19 | % | 21 | % | 14 | % | 19 | % | 2 | % | 3 | % | 6 | % | |||||||||
| Fiscal Year | Three Months Ended | ||||||||||||||||||||||||||
| ICL Sales by Country(4)(5) | 2021 | 2022 | 2023 | June 30, 2023 | September 29, 2023 | December 29, 2023 | March 29, 2024 | June 28, 2024 | September 27, 2024 | ||||||||||||||||||
| China | $ | 107,130 | $ | 147,967 | $ | 185,404 | $ | 61,288 | $ | 48,262 | $ | 40,813 | $ | 38,460 | $ | 63,345 | $ | 51,719 | |||||||||
| Growth | 50 | % | 38 | % | 25 | % | 33 | % | 14 | % | 30 | % | 10 | % | 3 | % | 7 | % | |||||||||
| Japan | $ | 28,688 | $ | 32,623 | $ | 36,352 | $ | 8,563 | $ | 9,091 | $ | 9,495 | $ | 10,227 | $ | 9,735 | $ | 10,490 | |||||||||
| Growth | 56 | % | 14 | % | 11 | % | 13 | % | 12 | % | 16 | % | 11 | % | 14 | % | 15 | % | |||||||||
| South Korea | $ | 15,173 | $ | 17,940 | $ | 19,853 | $ | 3,316 | $ | 4,886 | $ | 4,996 | $ | 6,725 | $ | 3,973 | $ | 5,434 | |||||||||
| Growth | 36 | % | 18 | % | 11 | % | (15 | )% | 1 | % | 39 | % | 1 | % | 20 | % | 11 | % | |||||||||
| United States | $ | 9,478 | $ | 15,070 | $ | 17,168 | $ | 4,446 | $ | 4,162 | $ | 4,164 | $ | 5,039 | $ | 5,541 | $ | 4,823 | |||||||||
| Growth | 58 | % | 59 | % | 14 | % | 10 | % | 6 | % | (8 | )% | 15 | % | 25 | % | 16 | % | |||||||||
| Notes: | |||||||||||||||||||||||||||
| (1) Americas includes the United States, Canada and Latin American countries | |||||||||||||||||||||||||||
| (2) EMEA includes Spain, Germany, United Kingdom, European, Middle East and Africa Distributors | |||||||||||||||||||||||||||
| (3) APAC includes China, Japan, South Korea, India and the rest of Asia Pacific distributors | |||||||||||||||||||||||||||
| (4) ICL Sales by country includes countries representing more than 5% of total ICL sales in the most recently completed fiscal year | |||||||||||||||||||||||||||
| (5) ICL sales do not include IOL, injector or other sales | |||||||||||||||||||||||||||
| Reconciliation of Non-GAAP Financial Measure | |||||||||||||||||||||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |||||
| Constant Currency Sales | |||||||||||||||||||||||||||
| (in 000's) | |||||||||||||||||||||||||||
| Unaudited | |||||||||||||||||||||||||||
| Three Months Ended | As Reported | Constant Currency | |||||||||||||||||||||||||
| Sales | September 27, 2024 | Effect of Currency | Constant Currency | September 29, 2023 | Change | % Change | Change | % Change | |||||||||||||||||||
| ICL | $ | 89,101 | $ | 300 | $ | 89,401 | $ | 81,069 | 9.9 | % | 10.3 | % | |||||||||||||||
| Cataract IOL | - | - | - | (221 | ) | (100.0 | )% | (100.0 | )% | ||||||||||||||||||
| Other | (511 | ) | (2 | ) | (513 | ) | (540 | ) | (5.4 | )% | (5.0 | )% | |||||||||||||||
| Total Sales | $ | 88,590 | $ | 298 | $ | 88,888 | $ | 80,308 | 10.3 | % | 10.7 | % | |||||||||||||||
| Year to Date | As Reported | Constant Currency | |||||||||||||||||||||||||
| Sales | September 27, 2024 | Effect of Currency | Constant Currency | September 29, 2023 | Change | % Change | Change | % Change | |||||||||||||||||||
| ICL | $ | 265,617 | $ | 2,515 | $ | 268,132 | $ | 244,806 | 8.5 | % | 9.5 | % | |||||||||||||||
| Cataract IOL | - | - | - | 1,295 | ) | (100.0 | )% | ) | (100.0 | )% | |||||||||||||||||
| Other | (666 | ) | 111 | (555 | ) | 41 | ) | (1724.4 | )% | ) | (1453.7 | )% | |||||||||||||||
| Total Sales | $ | 264,951 | $ | 2,626 | $ | 267,577 | $ | 246,142 | 7.6 | % | 8.7 | % |
All values are in US Dollars.
NASDAQ: STAA Third Quarter 2024 Earnings Presentation OCTOBER 30, 2024 Exhibit 99.2
02 STAAR Surgical Earnings Webcast Third Quarter 2024 Today’s Speakers Investor Relations PATRICK WILLIAMS TOM FRINZI Chair of the Board, President and CEO Chief Financial Officer http://investors.staar.com Brian Moore VP, Investor Relations and Corporate Development Connie Johnson Director, Investor Relations and High-Performance Management Niko Liu, CFA Director, Investor Relations and Corporate Development – Asia +1 626.303.7902 investorrelations@staar.com
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. Forward Looking Statements 03
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. The Company also presents certain financial information on a constant currency basis, which is intended to exclude the effects of foreign currency fluctuations. The Company conducts a significant part of its activities outside the U.S. It receives sales revenue and pays expenses principally in U.S. dollars, Swiss francs, Japanese yen and euros. The exchange rates between dollars and non-U.S. currencies can fluctuate greatly and can have a significant effect on the Company’s results when reported in U.S. dollars. In order to compare the Company's performance from period to period without the effect of currency, the Company will apply the same average exchange rate applicable in the prior period, or the “constant currency” rate to sales or expenses in the current period as well. 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. 04
STAAR Surgical + EVO ICL Around the World THIRD QUARTER 2024 EARNINGS PRESENTATION 05
Enhanced commercial focus and investments are driving growth In the third quarter, we achieved double-digit sales growth against a macroeconomic environment that softened in the second half of the quarter, particularly in China. STAAR is well positioned to navigate through the current market dynamics, which we believe are transitory. Looking ahead, we are encouraged by the recent shift in fiscal policy and announced stimulus in China and will continue to closely monitor the potential impact on our near to midterm growth outlook. Our focus on customer engagement and market expansion continues to yield solid results, helping drive industry-leading growth and market share gains. As our surgeon customers perform more EVO procedures, they are increasingly using our technology for moderate myopia, which underscores EVO ICL as the treatment choice for -6D and above and expands our total addressable market.” – Tom Frinzi Chair of the Board, President and CEO 06 STAAR / Q3 Results Reflect Continued Market Adoption & Share Gains Third Quarter 2024 Q3’24 GAAP Net Sales $340M - $345M Fiscal 2024 Net Sales Outlook Prior Outlook Maintained* Cash and Cash Equivalents as of Sep. 27, 2024 10% Q3'24 Global ICL Sales Growth 12% EMEA APAC 9% Surgeon Confidence Movement Down Diopter Curve Innovation 14% Americas $236.0M Our recent investments in customer education, innovative tools and comprehensive practice support, coupled with the advancement of our lower diopter strategies, are also expanding our total addressable market. * Prior outlook on August 7, 2024, was for net sales of $340M to $345M and Adjusted EBITDA of approximately $42M or $0.80 per diluted share. $88.6M
07 STAAR / Surgeon and HCP Professional Education Activities Third Quarter 2024 EVO ICL Experience Center Lake Forest, CA September 2024 ESCRS 42nd Annual Congress of the European Society of Cataract and Refractive Surgeons Barcelona, Spain September 2024 >80 ICL Papers Presentations EVO ICL as the choice for -6D and above.
08 STAAR / Accelerating ICL Sales Growth in Third Quarter Third Quarter 2024 Notes: (1) Americas includes the United States, Canada and Latin American countries (2) EMEA includes Spain, Germany, United Kingdom, European, Middle East and Africa distributors (3) APAC includes China, Japan, South Korea, India and the rest of Asia Pacific distributors (4) ICL sales do not include IOL, injector or other sales. Americas EMEA APAC GLOBAL ($ Millions) UNAUDITED U.S. ICL sales up 16% in Q3’24, significantly outpacing the market Signed three additional “Fast Lane” Highway 93 agreements; the eight Fast Lane customers with at least one full quarter of sales delivered 61% ICL sales growth in Q3’24 U.S. refractive procedures, predominantly laser vision correction, declined 18% in Q3’24.5 Growth driven primarily by the Middle East and European distributor markets Energized by the outperformance of our EMEA region this year; continue to benefit from our investments in this important market EMEA laser vision correction procedures were flat to down 5% in Q3’24.6 ICL Sales Growth Y/Y +14% +12% +9% +10% China ICL sales up 7% in Q3’24; unit growth was positive; early quarter momentum tapered Japan ICL sales up 15%; consistent double-digit unit growth in 32 of last 35 quarters South Korea ICL sales up 11% bolstered by country’s first ICL-only clinic China laser vision correction procedures declined 10-15% in Q3’24.6 10% global ICL sales growth reflects pricing power and 6% global ICL unit growth. Consistent with our August 7, 2024, commentary, we continue to expect the benefit from price to be approximately +3 points for FY24, i.e., sales growth to be 3 points higher than unit growth. Achieved double-digit sales growth against a softening macroeconomic environment in the second half of the quarter, particularly in China, which compares to generally down refractive procedures for the overall market in Q3’24 and YTD, globally. (5) Refractive Surgery Council (6) Company estimates
09 STAAR / Income Statement Third Quarter 2024 PATRICK WILLIAMS Chief Financial Officer Q3’24 net sales of $88.6M Net sales increased $8.3M or 10%; ICL sales increased $8.0M Constant Currency net sales of $88.9M increased 10% Q3’24 Gross profit of $68.5M or 77.3% of net sales Gross profit margin declined 190 bps Y/Y Y/Y gross margin change primarily due to higher CPUs Gross profit margin now expected to be ~79% for fiscal 2024 Dollars in millions Dollars in millions Net Sales Gross Profit
10 STAAR / Income Statement Operating Expenses For Q4’24, we continue to expect G&A expense to be approximately $24M For Q4’24, we now expect Selling and Marketing expense to be approximately $32M Third Quarter 2024 Research & Development $26.6M Yr Ago $28.8M Q2’24 Selling & Marketing $19.3M Yr Ago $23.6M Q2’24 $14.5M 71% General & Administrative $62.8M $26.6M $21.7M vs. $11.5M Yr Ago $14.1M Q2’24 vs. vs. Q3’24 Total Operating Expenses For Q4’24 we continue to expect R&D expense to be approximately $15M
Dollars in millions, except per share amounts GAAP Net Income Continued net income growth in the quarter Per share - Diluted Dollars in millions, except per share amounts Adjusted EBITDA 11 STAAR / Income Statement Continued cash generation in the quarter Per share - Diluted Third Quarter 2024
STAAR / Strong Balance Sheet and Cash Flows $236.0M Cash, Cash Equivalents & Investments as of September 27, 2024 ~ $30M FY 2024 CapEx Outlook ~ $42M FY 2024 Adjusted EBITDA Outlook No Debt as of September 27, 2024 12
STAAR / Sales Outlook Outlook Fiscal 2024 EVO ICL Sales Outlook and Global Diversity 13 $340M -$345M Fiscal 2024 Net Sales Outlook Maintained NEW PRIOR APAC China approx. 2% Growth All Other Countries Flat 5% EMEA 10% AMERICAS U.S. Growth of 20% for Fiscal 2024 17% APAC China approx. 10% Growth All Other Countries Flat 7% EMEA 6% AMERICAS U.S. Growth of 25% for Fiscal 2024 15% Chair of the Board, President and CEO TOM FRINZI
STAAR / Executing Against Our Strategic Priorities Strategic Priorities Growth Accelerators Pace of EVO ICL Adoption Down Diopter Curve is Accelerating Surgeon Confidence in Measurement and Lens Size Selection Own -6D and Above Refractive Vision Correction New Product Innovation 14 AI-Based Protocols for Measurement and Size Selection 01 01 U.S. Head-to-Head Study Harmonizing Label Indications 02 02 03 03 -20D -19D -18D -17D -16D -15D -14D -13D -12D -11D -10D -9D -8D -7D -6D -5D -4D -3D A diopter is a unit of measurement of the refractive power of a lens. 8.9 FISCAL 2022 8.7 FISCAL 2023 8.2 FISCAL 2024 YTD
Q&A STAAR SURGICAL THIRD QUARTER 2024 EARNINGS WEBCAST 15
Reconciliation of Non-GAAP Financial Measures STAAR Surgical 16 Additional 2024 Outlook Details Net Income to Adjusted EBITDA (in 000's except for per share data) Unaudited Provision for Income Tax is expected to be $0.3M in 4Q’24 Depreciation of approximately $1.5M in 4Q’24 Expect Other Income to be approximately $1.5M in 4Q’24 Expect stock-based compensation to be approximately $8M in 4Q’24 In order to reconcile Adjusted EBITDA from Net Income for our fiscal 2024 profitability Outlook, we are providing the following line item details as of October 30, 2024: (1) Adjusted EBITDA per diluted share may not add due to rounding. (2) 2024 Outlook lines items are all approximations and assumes breakeven Net Income. Q1-23 Q2-23 Q3-23 Q4-23 2023 Q1-24 Q2-24 Q3-24 2024 Outlook (2) Net income (as reported) $2,710 $6,064 $4,817 $7,756 $21,347 $(3,339) $7,379 $9,980 $3,800 Provision (benefit) for income taxes $2,009 $2,428 $1,929 $5,983 $12,349 $1,128 $2,955 $3,179 $7,600 Other (income) expense, net $(1,919) $105 $(451) $(3,334) $(5,599) $(70) $1,564 $(7,477) $(7,500) Depreciation $1,113 $1,285 $1,345 $1,368 $5,111 $1,237 $1,522 $1,757 $6,000 Other $7 $34 $15 $30 $86 - $26 $1,642 $1,700 Stock-based compensation $6,065 $8,423 $8,846 $182 $23,516 $6,339 $9,042 $7,160 $30,200 Adjusted EBITDA $9,985 $18,339 $16,501 $11,985 $56,810 $5,295 $22,488 $16,241 $41,800 Adjusted EBITDA as a % of Revenue 13.6% 19.9% 20.6% 15.7% 17.6% 6.8% 22.7% 18.3% 12.2% Net income per share, diluted- (as reported) $0.05 $0.12 $0.10 $0.16 $0.43 $(0.07) $0.15 $0.20 $0.07 Provision (benefit) for income taxes $0.04 $0.05 $0.04 $0.12 $0.25 $0.02 $0.06 $0.06 $0.15 Other (income) expense, net $(0.04) - $(0.01) $(0.07) $(0.11) - $0.03 $(0.15) $(0.14) Depreciation $0.02 $0.03 $0.03 $0.03 $0.10 $0.03 $0.03 $0.04 $0.12 Other - - - - - - - $0.03 $0.03 Stock-based compensation $0.12 $0.17 $0.18 - $0.48 $0.13 $0.18 $0.14 $0.58 Adjusted EBITDA per share, diluted(1) $0.20 $0.37 $0.33 $0.24 $1.15 $ 0.11 $ 0.45 $ 0.33 $0.80 Weighted average shares outstanding - Diluted 49,500 49,516 49,370 49,242 49,427 48,907 49,811 49,737 52,000 Other $1.6M non-cash write off related to former EVO Experience Center
ICL Sales by Geography Notes: (1) Americas includes the United States, Canada and Latin American countries (2) EMEA includes Spain, Germany, United Kingdom, European, Middle East and Africa distributors (3) APAC includes China, Japan, South Korea, India and the rest of Asia Pacific distributors (4) ICL Sales by country includes countries representing more than 5% of total ICL sales in the most recently completed fiscal year (5) ICL sales do not include IOL, injector or other sales. (IN 000’S) UNAUDITED ICL Sales by Region(5) ICL Sales by Country(4,5) 2021 2021 2022 2022 2023 2023 Sep 27, 2024 Sep 27, 2024 Jun 30, 2023 Jun 30, 2023 Sep 29, 2023 Sep 29, 2023 Dec 29, 2023 Dec 29, 2023 Mar 29, 2024 Mar 29, 2024 Jun 28, 2024 Jun 28, 2024 Americas(1) EMEA(2) APAC (3) Global ICL Sales Global ICL Sales Growth Americas ICL Sales Growth EMEA ICL Sales Growth APAC ICL Sales Growth Global ICL Unit Growth China Growth $14,054 $37,343 $161,508 $212,905 51% 59% 45% 51% 48% $107,130 50% $28,688 56% $15,173 36% $9,478 58% $20,114 $36,715 $212,883 $269,712 27% 43% (2%) 32% 33% $147,967 38% $32,623 14% $17,940 18% $15,070 59% $22,233 $39,318 $257,876 $319,427 18% 11% 7% 21% 19% $185,404 25% $36,352 11% $19,853 11% $17,168 14% $6,187 $10,333 $72,581 $89,101 10% 14% 12% 9% 6% $51,719 7% $10,490 15% $5,434 11% $4,823 16% $5,954 $9,782 $77,376 $93,112 19% 12% (11%) 26% 21% $61,288 33% $8,563 13% $3,316 (15)% $4,446 10% $5,449 $9,253 $66,367 $81,069 13% 5% 14% 13% 14% $48,262 14% $9,091 12% $4,886 1% $4,162 6% $6,260 $11,299 $59,592 $77,151 9% 12% 11% 9% 2% $38,460 10% $10,227 11% $6,725 1% $5,039 15% $5,264 $10,103 $59,254 $74,621 22% (8%) 18% 26% 19% $40,813 30% $9,495 16% $4,996 39% $4,164 (8)% $6,794 $10,727 $81,844 $99,365 7% 14% 10% 6% 3% $63,345 3% $9,735 14% $3,973 20% $5,541 25% FISCAL YEAR FISCAL YEAR THREE MONTHS ENDED THREE MONTHS ENDED Japan Growth South Korea Growth United States Growth 17