Full Press Release Details
STAAR Surgical Reports Third Quarter 2023 Results
Net Sales of $80.3 Million; ICL Sales of $81.1 Million Up 13% Y/Y
23rd Consecutive Quarter of Double-Digit ICL Sales Growth1
LAKE FOREST, CA, November 1, 2023 --- STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of the EVO family of Implantable Collamer Lenses (ICL) for myopia, astigmatism and presbyopia, today reported financial results for the third quarter ended September 29, 2023.
Third Quarter 2023 Overview
Net Sales of $80.3 Million Up 6% Y/Y includes a $0.8 Million sales reduction related to Other Products
ICL Sales of $81.1 Million Up 13% Y/Y
ICL Units Up 14% Y/Y
Gross Margin at 79.2% vs. 79.5% in the Prior Year Quarter
Net Income of $0.10 per Share vs. $0.21 per Share in the Prior Year Quarter
Cash, Cash Equivalents and Investments Available for Sale Ended the Quarter at $201.7 Million
Third quarter sales reflect our leadership in lens-based refractive surgery and progress advancing our strategic priorities, said Tom Frinzi, President and CEO of STAAR Surgical. Our global ICL sales growth of 13% in the third quarter significantly outperformed industry procedure growth, which was negative in many markets around the world with the exception of China.2 Further, we are mindful of the potential impact the uncertain economic environment globally and world events may have on our surgeon customers and patients. As a result, we now expect fiscal 2023 ICL sales to be at the low end of our previously provided range of $320 million to $325 million.
Frinzi continued, We expect our current efforts will deliver our sixth straight year of sales growth and profitability in fiscal 2023 while investing in the initiatives that support development of our surgeon customers and prospects as we drive global adoption of our EVO ICL technology. Over the three-year planning horizon, our focus remains on achieving a 15% to 20% compound annual growth rate in sales as our ICL technology addresses the global myopia epidemic, continuing to take market share and growing the overall market for refractive procedures.
Financial Overview Q3 2023
Net sales were $80.3 million for the third quarter of 2023, up 6% compared to $76.1 million reported in the prior year quarter. The sales increase in the third quarter was driven by ICL sales growth of 13% and ICL unit growth of 14%, both as compared to the prior year period. Other Product sales for the third quarter of 2023 were ($0.8) million compared to $4.1 million in the prior year quarter. The $4.9 million change in Other Product sales reflects a $2.4 million reduction in Cataract IOL sales and a $2.4 million reduction in other product sales due to decreased sales of cataract injector parts and increased sales return reserves. ICL sales were $81.1 million for the third quarter of 2023.
Gross profit margin for the third quarter of 2023 was 79.2% compared to the prior year quarter of 79.5%. Factors impacting gross margin in the third quarter of 2023, as compared to the prior year quarter, include increased sales return reserves and period costs associated with manufacturing projects, partially offset by product and geographic sales mix.
Operating expenses for the third quarter of 2023 were $57.3 million compared to the prior year quarter of $46.8 million. General and administrative expenses were $19.3 million compared to the prior year quarter of $14.0 million. The increase in general and administrative expenses was due to increased compensation related expenses, outside services and facilities costs. Selling and marketing expenses were $26.6 million compared to the prior year quarter of $23.1 million. The increase in selling and marketing expenses is due to increased advertising and promotional expenses and compensation expenses, partially offset by decreased trade show expenses. Research and development expenses were $11.5 million compared to the prior year quarter of $9.6 million. The increase in research and development expenses is due to increased compensation related expenses and clinical trial expenses related to U.S. post-approval studies.
Net income for the third quarter of 2023 was $4.8 million or $0.10 per diluted share compared with net income of $10.3 million or $0.21 per diluted share for the prior year quarter. The year over year decrease in net income is attributable to higher operating expenses partially offset by higher gross profit and other income (expense). Adjusted Net Income for the third quarter of 2023 was $15.0 million or $0.30 per diluted share compared to $18.1 million or $0.37 per diluted share for the prior year quarter. The reconciliation between GAAP and non-GAAP financial information is provided in the financial tables included with this release.
Cash, cash equivalents, and investments available for sale at September 29, 2023, totaled $201.7 million, compared to $225.5 million at end of the fourth quarter of 2022.
1 Excludes Q1 and Q2 2020, which were impacted by the COVID-19 global pandemic.
2 Refractive Surgery Council, RSC Quarterly Statistical Program, Q3 2023 Report, U.S. refractive procedure volumes down 15.1% Y/Y in Q3 2023 and down 13.1% for the first nine months of 2023 and Company estimates using Market Scope 2023 Refractive Procedures Market Trends, October 27, 2023.
The Company will host a conference call and webcast today, Wednesday, November 1 at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and operational progress. To access the conference call (Conference ID 03857916), please dial 888-259-6580 for domestic participants and 206-962-3782 for international participants. The live webcast can be accessed from the investor relations section of the STAAR website at www.staar.com.
A taped replay of the conference call (Replay Code 857916) will be available beginning approximately one hour after the call's conclusion for seven days. This replay can be accessed by dialing 877-674-7070 for domestic callers and 416-764-8692 for international callers. An archived webcast will also be available at www.staar.com.
Use of Non-GAAP Financial Measures
This press release includes supplemental Non-GAAP financial information, which STAAR believes investors will find helpful in understanding its operating performance. Non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.
Adjusted Net Income and Adjusted Net Income for ICL exclude the following items that are included in Net Income as calculated in accordance with U.S. generally accepted accounting principles ( GAAP ): Cataract IOL sales return reserve, Cataract IOL excess inventory reserves, Cataract IOL intangible impairment, and income tax benefit on Cataract IOL Adjusted Net Income also excludes gain or loss on foreign currency transactions, stock-based compensation expenses, and valuation allowance adjustments (if any). Management believes that Adjusted Net Income and Adjusted Net Income for ICL are useful to investors in gauging the outcome of the key drivers of the business performance: the ability to increase sales revenue and our ability to increase profit margin by improving the mix of high value products while reducing the costs over which management has control.
Management has excluded accounting adjustments related to exiting the Company's non-core Cataract IOL business. These accounting adjustments include sales return reserve, excess inventory reserves, an intangible impairment charge related to cataract IOLs and the associated tax benefit of these adjustments. The Company has excluded these items in order to focus on its core ICL business as the Company will continue tapering the manufacturing of cataract IOLs, though it will continue to support these products through the end of 2023, as supplies permit. Management believes that disclosing Adjusted Net Income and Adjusted Net Income for ICL excluding these accounting adjustments is useful to investors in gauging the performance of its core ICL business.
For the reasons referenced above in connection with calculating Adjusted Net Income and Adjusted Net Income for ICL, management also supplements the Company's GAAP consolidated financial statements and GAAP financial measures with other Non-GAAP financial measures, comprising of Adjusted Net Sales, Adjusted Cost of Sales, Adjusted Gross Profit Margin, Adjusted Operating Expenses, Adjusted Income Tax Provision, which in each case exclude the impact of any accounting adjustments related to the exiting of the Company's non-core Cataract IOL business. The Company believes that these Non-GAAP financial measures provide additional insight into the ongoing financial results of its business which investors find useful to gauge the performance of its core ICL business.
Management has also excluded from the calculation of Adjusted Net Income gains and losses on foreign currency transactions because of the significant fluctuations that can result from period to period as a result of market driven factors. Stock-based compensation expenses consist of expenses for stock options and restricted stock under the Financial Accounting Standards Board's Accounting Standards Codification (ASC) 718. Valuation allowance adjustments can occur from time to time based on forecasted changes in operating results until all net operating loss carryforwards are fully utilized. In calculating Adjusted Net Income, STAAR excludes stock-based compensation expenses and valuation allowance adjustments (if any) because they are non-cash expenses and because of the considerable judgment involved in calculating their values. In addition, these expenses tend to be driven by fluctuations in the price of our stock and not by the same factors that generally affect our other business expenses.
The Company also uses Constant Currency as a Non-GAAP financial measure to exclude the effects of currency fluctuations on net sales. 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. Because changes in currency are outside of the control of the Company and its managers, management finds this Non-GAAP measure useful in determining the long-term progress of its initiatives and determining whether its managers are achieving their performance goals. The Company believes that the Non-GAAP constant-currency sales results measures provided in this press release are similarly useful to investors to give insight on long term trends in the Company's performance without the external effect of changes in relative currency values. The table provided in this press release shows sales results calculated in accordance with GAAP, the effect of currency, and the resulting Non-GAAP measure expressed in constant currency.
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 2,500,000 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.
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 2023 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 2023 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 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 30, 2022 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 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 or after approval, or to take enforcement action; international 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 and Media
Vice President, Investor Relations and Corporate Development
(626) 303-7902, Ext. 3023
Consolidated Balance Sheets
| ASSETS | September 29, 2023 | December 30, 2022 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 127,432 | $ | 86,480 | ||||
| Investments available for sale | 60,681 | 125,159 | ||||||
| Accounts receivable trade, net | 112,367 | 62,447 | ||||||
| Inventories, net | 31,061 | 24,161 | ||||||
| Prepayments, deposits, and other current assets | 15,527 | 13,476 | ||||||
| Total current assets | 347,068 | 311,723 | ||||||
| Investments available for sale | 13,627 | 13,902 | ||||||
| Property, plant, and equipment, net | 62,886 | 50,921 | ||||||
| Finance lease right-of-use assets, net | 220 | 342 | ||||||
| Operating lease right-of-use assets, net | 34,992 | 30,270 | ||||||
| Intangible assets, net | - | 173 | ||||||
| Goodwill | 1,786 | 1,786 | ||||||
| Deferred income taxes | 8,560 | 8,744 | ||||||
| Other assets | 2,382 | 957 | ||||||
| Total assets | $ | 471,521 | $ | 418,818 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 8,786 | $ | 11,576 | ||||
| Obligations under finance leases | 164 | 169 | ||||||
| Obligations under operating leases | 4,003 | 3,524 | ||||||
| Allowance for sales returns | 7,557 | 5,706 | ||||||
| Other current liabilities | 36,265 | 30,741 | ||||||
| Total current liabilities | 56,775 | 51,716 | ||||||
| Obligations under finance leases | 84 | 210 | ||||||
| Obligations under operating leases | 31,643 | 27,136 | ||||||
| Deferred income taxes | 1,295 | 1,489 | ||||||
| Asset retirement obligations | 98 | 220 | ||||||
| Pension liability | 3,031 | 1,935 | ||||||
| Total liabilities | 92,926 | 82,706 | ||||||
| Stockholders' equity: | ||||||||
| Common stock | 488 | 482 | ||||||
| Additional paid-in capital | 436,117 | 404,189 | ||||||
| Accumulated other comprehensive income (loss) | (2,886 | ) | 156 | |||||
| Accumulated deficit | (55,124 | ) | (68,715 | ) | ||||
| Total stockholders' equity | 378,595 | 336,112 | ||||||
| Total liabilities and stockholders' equity | $ | 471,521 | $ | 418,818 |
Consolidated Statements of Income
(In 000's except for per share data)
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||
| % of | % of | Fav (Unfav) | % of | % of | Fav (Unfav) | |||||||||||||||||||||||||||||||||||||||||||
| Sales | September 29, 2023 | Sales | September 30, 2022 | Amount | % | Sales | September 29, 2023 | Sales | September 30, 2022 | Amount | % | |||||||||||||||||||||||||||||||||||||
| Net sales | 100.0 | % | $ | 80,308 | 100.0 | % | $ | 76,046 | $ | 4,262 | 5.6 | % | 100.0 | % | $ | 246,142 | 100.0 | % | $ | 220,347 | $ | 25,795 | 11.7 | % | ||||||||||||||||||||||||
| Cost of sales | 20.8 | % | 16,670 | 20.5 | % | 15,584 | (1,086 | ) | -7.0 | % | 22.0 | % | 54,216 | 21.2 | % | 46,749 | (7,467 | ) | -16.0 | % | ||||||||||||||||||||||||||||
| Gross profit | 79.2 | % | 63,638 | 79.5 | % | 60,462 | 3,176 | 5.3 | % | 78.0 | % | 191,926 | 78.8 | % | 173,598 | 18,328 | 10.6 | % | ||||||||||||||||||||||||||||||
| Selling, general and administrative expenses: | ||||||||||||||||||||||||||||||||||||||||||||||||
| General and administrative | 24.0 | % | 19,266 | 18.4 | % | 14,011 | (5,255 | ) | -37.5 | % | 22.6 | % | 55,461 | 18.1 | % | 39,934 | (15,527 | ) | -38.9 | % | ||||||||||||||||||||||||||||
| Selling and marketing | 33.1 | % | 26,607 | 30.4 | % | 23,130 | (3,477 | ) | -15.0 | % | 34.6 | % | 85,238 | 29.3 | % | 64,633 | (20,605 | ) | -31.9 | % | ||||||||||||||||||||||||||||
| Research and development | 14.3 | % | 11,470 | 12.7 | % | 9,616 | (1,854 | ) | -19.3 | % | 13.6 | % | 33,535 | 12.0 | % | 26,193 | (7,342 | ) | -28.0 | % | ||||||||||||||||||||||||||||
| Total selling, general, and administrative expenses | 71.4 | % | 57,343 | 61.5 | % | 46,757 | (10,586 | ) | -22.6 | % | 70.8 | % | 174,234 | 59.4 | % | 130,760 | (43,474 | ) | -33.2 | % | ||||||||||||||||||||||||||||
| Operating income | 7.8 | % | 6,295 | 18.0 | % | 13,705 | (7,410 | ) | -54.1 | % | 7.2 | % | 17,692 | 19.4 | % | 42,838 | (25,146 | ) | -58.7 | % | ||||||||||||||||||||||||||||
| Other income (expense), net: | ||||||||||||||||||||||||||||||||||||||||||||||||
| Interest income, net | 2.1 | % | 1,690 | 1.2 | % | 897 | 793 | 88.4 | % | 2.1 | % | 5,287 | 0.4 | % | 934 | 4,353 | 466.1 | % | ||||||||||||||||||||||||||||||
| Loss on foreign currency transactions | -1.7 | % | (1,384 | ) | -2.8 | % | (2,129 | ) | 745 | 35.0 | % | -1.3 | % | (3,240 | ) | -2.2 | % | (4,904 | ) | 1,664 | 33.9 | % | ||||||||||||||||||||||||||
| Royalty income | 0.1 | % | 74 | 0.1 | % | 77 | (3 | ) | -3.9 | % | 0.0 | % | 74 | 0.2 | % | 527 | (453 | ) | -86.0 | % | ||||||||||||||||||||||||||||
| Other income, net | 0.1 | % | 71 | 0.0 | % | 27 | 44 | 163.0 | % | 0.1 | % | 144 | 0.1 | % | 178 | (34 | ) | -19.1 | % | |||||||||||||||||||||||||||||
| Total other income (expense), net | 0.6 | % | 451 | -1.5 | % | (1,128 | ) | 1,579 | 140.0 | % | 0.9 | % | 2,265 | -1.5 | % | (3,265 | ) | 5,530 | 169.4 | % | ||||||||||||||||||||||||||||
| Income before provision for income taxes | 8.4 | % | 6,746 | 16.5 | % | 12,577 | (5,831 | ) | -46.4 | % | 8.1 | % | 19,957 | 17.9 | % | 39,573 | (19,616 | ) | -49.6 | % | ||||||||||||||||||||||||||||
| Provision for income taxes | 2.4 | % | 1,929 | 3.0 | % | 2,315 | 386 | 16.7 | % | 2.6 | % | 6,366 | 3.0 | % | 6,671 | 305 | 4.6 | % | ||||||||||||||||||||||||||||||
| Net income | 6.0 | % | $ | 4,817 | 13.5 | % | $ | 10,262 | $ | (5,445 | ) | -53.1 | % | 5.5 | % | $ | 13,591 | 14.9 | % | $ | 32,902 | $ | (19,311 | ) | -58.7 | % | ||||||||||||||||||||||
| Net income per share - basic | $ | 0.10 | $ | 0.21 | $ | 0.28 | $ | 0.69 | ||||||||||||||||||||||||||||||||||||||||
| Net income per share - diluted | $ | 0.10 | $ | 0.21 | $ | 0.27 | $ | 0.67 | ||||||||||||||||||||||||||||||||||||||||
| Weighted average shares outstanding - basic | 48,613 | 48,102 | 48,426 | 47,915 | ||||||||||||||||||||||||||||||||||||||||||||
| Weighted average shares outstanding - diluted | 49,370 | 49,549 | 49,494 | 49,371 |
Consolidated Statements of Cash Flows
| Three Months Ended | Nine Months Ended | ||||||||||||||||
| September 29, 2023 | September 30, 2022 | September 29, 2023 | September 30, 2022 | ||||||||||||||
| Cash flows from operating activities: | |||||||||||||||||
| Net income | $ | 4,817 | $ | 10,262 | $ | 13,591 | $ | 32,902 | |||||||||
| Adjustments to reconcile net income to net cash provided by (used in) operating activities: | |||||||||||||||||
| Depreciation of property and equipment | 1,345 | 1,077 | 3,743 | 3,101 | |||||||||||||
| Amortization/Impairment of long-lived intangibles | (2 | ) | 7 | 169 | 22 | ||||||||||||
| Accretion/Amortization of investments available for sale | (348 | ) | (307 | ) | (2,172 | ) | (307 | ) | |||||||||
| Deferred income taxes | (10 | ) | 23 | 65 | 23 | ||||||||||||
| Change in net pension liability | (139 | ) | (12 | ) | (766 | ) | 40 | ||||||||||
| Stock-based compensation expense | 8,846 | 5,727 | 23,334 | 15,375 | |||||||||||||
| Change in asset retirement obligation | 3 | - | (104 | ) | - | ||||||||||||
| Loss on disposal of property and equipment | 17 | - | 41 | - | |||||||||||||
| Provision for sales returns and bad debts | 921 | (439 | ) | 1,925 | 361 | ||||||||||||
| Inventory provision | 460 | 592 | 4,090 | 2,020 | |||||||||||||
| Changes in working capital: | |||||||||||||||||
| Accounts receivable | (18,092 | ) | 7,029 | (50,436 | ) | (13,108 | ) | ||||||||||
| Inventories | (5,593 | ) | (2,298 | ) | (9,975 | ) | (4,123 | ) | |||||||||
| Prepayments, deposits and other current assets | (919 | ) | 2,786 | (3,584 | ) | 526 | |||||||||||
| Accounts payable | (1,819 | ) | (5,077 | ) | (3,266 | ) | (1,834 | ) | |||||||||
| Other current liabilities | 4,538 | 4,739 | 5,970 | (2,253 | ) | ||||||||||||
| Net cash provided by (used in) operating activities | (5,975 | ) | 24,109 | (17,375 | ) | 32,745 | |||||||||||
| Cash flows from investing activities: | |||||||||||||||||
| Acquisition of property and equipment | (9,185 | ) | (6,273 | ) | (15,100 | ) | (14,083 | ) | |||||||||
| Purchase of investments available for sale | (9,712 | ) | (95,576 | ) | (52,314 | ) | (95,576 | ) | |||||||||
| Proceeds from sale or maturity of investments available for sale | 50,737 | - | 119,359 | - | |||||||||||||
| Net cash provided by (used in) investing activities | 31,840 | (101,849 | ) | 51,945 | (109,659 | ) | |||||||||||
| Cash flows from financing activities: | |||||||||||||||||
| Repayment of finance lease obligations | (39 | ) | (40 | ) | (121 | ) | (85 | ) | |||||||||
| Repurchase of employee common stock for taxes withheld | (112 | ) | - | (2,096 | ) | - | |||||||||||
| Proceeds from vested restricted stock and exercise of stock options | 7,258 | 5,034 | 9,265 | 8,180 | |||||||||||||
| Net cash provided by financing activities | 7,107 | 4,994 | 7,048 | 8,095 | |||||||||||||
| Effect of exchange rate changes on cash and cash equivalents | (235 | ) | (502 | ) | (666 | ) | (1,645 | ) | |||||||||
| Increase (decrease) in cash and cash equivalents | 32,737 | (73,248 | ) | 40,952 | (70,464 | ) | |||||||||||
| Cash and cash equivalents, at beginning of the period | 94,695 | 202,490 | 86,480 | 199,706 | |||||||||||||
| Cash and cash equivalents, at end of the period | $ | 127,432 | $ | 129,242 | $ | 127,432 | $ | 129,242 | |||||||||
| Check - ending cash | $ | - | $ | - |
Reconciliation of Non-GAAP Financial Measure
Financial Metrics Excluding Other Product Cataract IOL Adjustmenrts
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||
| Fav (Unfav) | Fav (Unfav) | |||||||||||||||||||||||||||||||||||||||||||||||
| % of Sales | September 29, 2023 | % of Sales | September 30, 2022 | Amount | % | % of Sales | September 29, 2023 | % of Sales | September 30, 2022 | Amount | % | |||||||||||||||||||||||||||||||||||||
| Net sales: | ||||||||||||||||||||||||||||||||||||||||||||||||
| Net sales, GAAP | 100.0 | % | $ | 80,308 | 100.0 | % | $ | 76,046 | $ | 4,262 | 5.6 | % | 100.0 | % | $ | 246,142 | 100.0 | % | $ | 220,347 | $ | 25,795 | 11.7 | % | ||||||||||||||||||||||||
| Add: Cataract IOL sales return reserve | - | - | - | 742 | - | 742 | ||||||||||||||||||||||||||||||||||||||||||
| Adjusted Net sales, Non-GAAP | 100.0 | % | $ | 80,308 | 100.0 | % | $ | 76,046 | $ | 4,262 | 5.6 | % | 100.0 | % | $ | 246,884 | 100.0 | % | $ | 220,347 | $ | 26,537 | 12.0 | % | ||||||||||||||||||||||||
| Cost of sales: | ||||||||||||||||||||||||||||||||||||||||||||||||
| Cost of sales, GAAP | 20.8 | % | $ | 16,670 | 20.5 | % | $ | 15,584 | $ | (1,086 | ) | -7.0 | % | 22.0 | % | $ | 54,216 | 21.2 | % | $ | 46,749 | $ | (7,467 | ) | -16.0 | % | ||||||||||||||||||||||
| Less: Cataract IOL inventory reserve | - | - | - | (2,800 | ) | - | 2,800 | |||||||||||||||||||||||||||||||||||||||||
| Adjusted Cost of sales, Non-GAAP | 20.8 | % | $ | 16,670 | 20.5 | % | $ | 15,584 | $ | (1,086 | ) | -7.0 | % | 20.8 | % | $ | 51,416 | 21.2 | % | $ | 46,749 | $ | (4,667 | ) | -10.0 | % | ||||||||||||||||||||||
| Gross profit and gross profit margin: | ||||||||||||||||||||||||||||||||||||||||||||||||
| Gross profit and gross profit margin, GAAP | 79.2 | % | $ | 63,638 | 79.5 | % | $ | 60,462 | $ | 3,176 | 5.3 | % | 78.0 | % | $ | 191,926 | 78.8 | % | $ | 173,598 | $ | 18,328 | 10.6 | % | ||||||||||||||||||||||||
| Add: Cataract IOL sales return reserve | - | - | - | 742 | - | 742 | ||||||||||||||||||||||||||||||||||||||||||
| Add: Cataract IOL inventory reserve | - | - | - | 2,800 | - | 2,800 | ||||||||||||||||||||||||||||||||||||||||||
| Adjusted Gross profit and gross profit margin, Non-GAAP | 79.2 | % | $ | 63,638 | 79.5 | % | $ | 60,462 | $ | 3,176 | 5.3 | % | 79.2 | % | $ | 195,468 | 78.8 | % | $ | 173,598 | $ | 21,870 | 12.6 | % | ||||||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||||||||||||||||||||||||||
| Operating expenses, GAAP | 71.4 | % | $ | 57,343 | 61.5 | % | $ | 46,757 | $ | (10,586 | ) | -22.6 | % | 70.8 | % | $ | 174,234 | 59.3 | % | $ | 130,760 | $ | (43,474 | ) | -33.2 | % | ||||||||||||||||||||||
| Less: Cataract IOL intangible impairment | - | - | - | (154 | ) | - | 154 | |||||||||||||||||||||||||||||||||||||||||
| Adjusted Operating expenses, Non-GAAP | 71.4 | % | $ | 57,343 | 61.5 | % | $ | 46,757 | $ | (10,586 | ) | -22.6 | % | 70.5 | % | $ | 174,080 | 59.3 | % | $ | 130,760 | $ | (43,320 | ) | -33.1 | % | ||||||||||||||||||||||
| Provision for income taxes: | ||||||||||||||||||||||||||||||||||||||||||||||||
| Provision for income taxes, GAAP | 2.4 | % | $ | 1,929 | 3.0 | % | $ | 2,315 | $ | 386 | 16.7 | % | 2.6 | % | $ | 6,366 | 3.0 | % | $ | 6,671 | $ | 305 | 4.6 | % | ||||||||||||||||||||||||
| Add: Income tax benefit on Cataract IOL | - | - | - | 405 | - | (405 | ) | |||||||||||||||||||||||||||||||||||||||||
| Adjusted Provision for income taxes, Non-GAAP | 2.4 | % | $ | 1,929 | 3.0 | % | $ | 2,315 | $ | 386 | 16.7 | % | 2.7 | % | $ | 6,771 | 3.0 | % | $ | 6,671 | $ | (100 | ) | -1.5 | % |
Reconciliation of Non-GAAP Financial Measure
Adjusted Net Income and Net Income Per Share
| Unaudited | Three Months Ended | Nine Months Ended | ||||||||||||||
| September 29, 2023 | September 30, 2022 | September 29, 2023 | September 30, 2022 | |||||||||||||
| $ | 4,817 | $ | 10,262 | $ | 13,591 | $ | 32,902 | |||||||||
| Net income (as reported) | ||||||||||||||||
| Less | - | - | 742 | - | ||||||||||||
| Cataract IOL sales return reserve | - | - | 2,800 | - | ||||||||||||
| Cataract IOL inventory reserve | - | - | 154 | - | ||||||||||||
| Cataract IOL intangible impairment | - | - | (405 | ) | - | |||||||||||
| Income tax benefit on Cataract IOL | 4,817 | 10,262 | 16,882 | 32,902 | ||||||||||||
| Adjusted net income for ICL | ||||||||||||||||
| Less: | 1,384 | 2,129 | 3,240 | 4,904 | ||||||||||||
| Foreign currency impact | 8,846 | 5,727 | 23,334 | 15,375 | ||||||||||||
| Valuation allowance adjustment | $ | 15,047 | $ | 18,118 | $ | 43,456 | $ | 53,181 | ||||||||
| Net income (adjusted) | ||||||||||||||||
| $ | 0.10 | $ | 0.21 | $ | 0.28 | $ | 0.69 | |||||||||
| Net income per share, basic (as reported) | - | - | 0.02 | - | ||||||||||||
| Cataract IOL sales return reserve | - | - | 0.06 | - | ||||||||||||
| Cataract IOL inventory reserve | - | - | - | - | ||||||||||||
| Cataract IOL intangible impairment | - | - | (0.01 | ) | - | |||||||||||
| Income tax benefit on Cataract IOL | 0.10 | 0.21 | 0.35 | 0.69 | ||||||||||||
| Adjusted net income for ICL per share, basic | 0.03 | 0.05 | 0.07 | 0.10 | ||||||||||||
| Foreign currency impact | 0.18 | 0.12 | 0.48 | 0.32 | ||||||||||||
| Valuation allowance adjustment | $ | 0.31 | $ | 0.38 | $ | 0.90 | $ | 1.11 | ||||||||
| Net income per share, basic (adjusted) | ||||||||||||||||
| $ | 0.10 | $ | 0.21 | $ | 0.27 | $ | 0.67 | |||||||||
| Net income per share, diluted (as reported) | - | - | 0.01 | - | ||||||||||||
| Cataract IOL sales return reserve | - | - | 0.06 | - | ||||||||||||
| Cataract IOL inventory reserve | - | - | - | - | ||||||||||||
| Cataract IOL intangible impairment | - | - | (0.01 | ) | - | |||||||||||
| Income tax benefit on Cataract IOL | 0.10 | 0.21 | 0.34 | 0.67 | ||||||||||||
| Adjusted net income for ICL per share, diluted | 0.03 | 0.04 | 0.07 | 0.10 | ||||||||||||
| Foreign currency impact | 0.18 | 0.12 | 0.47 | 0.31 | ||||||||||||
| Valuation allowance adjustment | $ | 0.30 | $ | 0.37 | $ | 0.88 | $ | 1.08 | ||||||||
| Net income per share, diluted (adjusted) | ||||||||||||||||
| 48,613 | 48,102 | 48,426 | 47,915 | |||||||||||||
| Weighted average shares outstanding - Basic | 49,370 | 49,549 | 49,494 | 49,371 |
Note: Net income per share (adjusted), basic and diluted, may not add due to rounding
STAAR Surgical Company
ICL Sales by Geography
| Fiscal Year | Three Months Ended | |||||||||||||||||||||||||||||||||||
| ICL Sales by Region | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | September 29, 2023 | September 30, 2022 | |||||||||||||||||||||||||||
| Americas (1) | $ | 8,663 | $ | 8,581 | $ | 9,112 | $ | 10,250 | $ | 8,834 | $ | 14,054 | $ | 20,114 | $ | 5,449 | $ | 5,168 | ||||||||||||||||||
| EMEA (2) | 19,330 | 21,334 | 25,626 | 26,398 | 25,748 | 37,343 | 36,715 | 9,253 | 8,111 | |||||||||||||||||||||||||||
| APAC (3) | 31,118 | 38,410 | 66,343 | 92,673 | 106,825 | 161,508 | 212,883 | 66,367 | 58,674 | |||||||||||||||||||||||||||
| Global ICL Sales | $ | 59,111 | $ | 68,325 | $ | 101,081 | $ | 129,321 | $ | 141,407 | $ | 212,905 | $ | 269,712 | $ | 81,069 | $ | 71,953 | ||||||||||||||||||
| Global ICL Sales Growth | 15 | % | 16 | % | 48 | % | 28 | % | 9 | % | 51 | % | 27 | % | 13 | % | 33 | % | ||||||||||||||||||
| Global ICL Unit Growth | 11 | % | 17 | % | 54 | % | 33 | % | 11 | % | 48 | % | 33 | % | 14 | % | 40 | % | ||||||||||||||||||
| Fiscal Year | Three Months Ended | |||||||||||||||||||||||||||||||||||
| ICL Sales by Country (4)(5) | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | September 29, 2023 | September 30, 2022 | |||||||||||||||||||||||||||
| China | $ | 16,238 | $ | 24,088 | $ | 45,915 | $ | 64,770 | $ | 71,600 | $ | 107,130 | $ | 147,967 | $ | 48,262 | $ | 42,246 | ||||||||||||||||||
| Growth | 35 | % | 48 | % | 91 | % | 41 | % | 11 | % | 50 | % | 38 | % | 14 | % | 49 | % | ||||||||||||||||||
| Japan | $ | 2,746 | $ | 3,695 | $ | 7,037 | $ | 11,774 | $ | 18,366 | $ | 28,688 | $ | 32,623 | $ | 9,091 | $ | 8,134 | ||||||||||||||||||
| Growth | 51 | % | 35 | % | 90 | % | 67 | % | 56 | % | 56 | % | 14 | % | 12 | % | 12 | % | ||||||||||||||||||
| South Korea | $ | 7,453 | $ | 5,540 | $ | 7,564 | $ | 9,517 | $ | 11,119 | $ | 15,173 | $ | 17,940 | $ | 4,886 | $ | 4,857 | ||||||||||||||||||
| Growth | -7 | % | -26 | % | 37 | % | 26 | % | 17 | % | 36 | % | 18 | % | 1 | % | 50 | % | ||||||||||||||||||
| United States | $ | 6,055 | $ | 5,744 | $ | 5,792 | $ | 7,210 | $ | 6,003 | $ | 9,478 | $ | 15,070 | $ | 4,162 | $ | 3,920 | ||||||||||||||||||
| Growth | 7 | % | -5 | % | 1 | % | 24 | % | -17 | % | 58 | % | 59 | % | 6 | % | 75 | % |
(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.
STAAR Surgical Company
Reconciliation of Non-GAAP Financial Measure
Constant Currency Sales
| Three Months Ended | ||||||||||||||||||||||||||||||||
| Effect of | Constant | As Reported | Constant Currency | |||||||||||||||||||||||||||||
| Sales | September 29, 2023 | Currency | Currency | September 30, 2022 | $ Change | % Change | $ Change | % Change | ||||||||||||||||||||||||
| ICL | $ | 81,069 | $ | (112 | ) | $ | 80,957 | $ | 71,953 | $ | 9,116 | 12.7 | % | $ | 9,004 | 12.5 | % | |||||||||||||||
| Cataract IOL | (221 | ) | 13 | (208 | ) | 2,191 | (2,412 | ) | -110.1 | % | (2,399 | ) | -109.5 | % | ||||||||||||||||||
| Other | (540 | ) | (8 | ) | (548 | ) | 1,902 | (2,442 | ) | -128.4 | % | (2,450 | ) | -128.8 | % | |||||||||||||||||
| Other Products | (761 | ) | 5 | (756 | ) | 4,093 | (4,854 | ) | -118.6 | % | (4,849 | ) | -118.5 | % | ||||||||||||||||||
| Total Sales | $ | 80,308 | $ | (107 | ) | $ | 80,201 | $ | 76,046 | $ | 4,262 | 5.6 | % | $ | 4,155 | 5.5 | % | |||||||||||||||
| Nine Months Ended | ||||||||||||||||||||||||||||||||
| Effect of | Constant | As Reported | Constant Currency | |||||||||||||||||||||||||||||
| Sales | September 29, 2023 | Currency | Currency | September 30, 2022 | $ Change | % Change | $ Change | % Change | ||||||||||||||||||||||||
| ICL | $ | 244,806 | $ | 2,004 | $ | 246,810 | $ | 208,550 | $ | 36,256 | 17.4 | % | $ | 38,260 | 18.3 | % | ||||||||||||||||
| Cataract IOL | 1,295 | 172 | 1,467 | 7,640 | (6,345 | ) | -83.0 | % | (6,173 | ) | -80.8 | % | ||||||||||||||||||||
| Other | 41 | 104 | 145 | 4,157 | (4,116 | ) | -99.0 | % | (4,012 | ) | -96.5 | % | ||||||||||||||||||||
| Other Products | 1,336 | 276 | 1,612 | 11,797 | (10,461 | ) | -88.7 | % | (10,185 | ) | -86.3 | % | ||||||||||||||||||||
| Total Sales | $ | 246,142 | $ | 2,280 | $ | 248,422 | $ | 220,347 | $ | 25,795 | 11.7 | % | $ | 28,075 | 12.7 | % |