Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 30, 2022 For the transition period from to Commission file number: 0-11634 STAAR SURGICAL COMPANY (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or o ...

Financial Data and Key Metrics Changes - In fiscal 2022, the company reported net sales of $284 million, with a negative impact of $12.9 million from changes in constant currency [7][70] - For Q4 2022, total net sales were $64 million, a 5 million year-over-year increase from $59 million in Q4 2021, driven by a 15% increase in ICL sales [70] - Operating income for fiscal 2022 was $43.8 million, representing 15.4% of net sales, compared to $33.3 million or 14.5% of net sales for fiscal 2021 [83] - Gross profit for Q4 2022 was $49.8 million, or 77.7% of net sales, compared to 76.3% in Q4 2021 [82] Business Line Data and Key Metrics Changes - ICL sales grew 27% year-over-year, with ICL units increasing by 33% [4] - In Q4 2022, ICL unit growth was up 20% year-over-year, with significant growth in the U.S. at 109% [80][105] - The company plans to discontinue its non-core lower-margin cataract IOL business after 2023 [70] Market Data and Key Metrics Changes - In China, ICL unit growth was 18% in Q4 2022, with Japan at 33% and India at 19% [80] - U.S. sales in Q4 2022 were approximately $4.5 million, reflecting a 94% year-over-year increase [107] - Doctor Finder visits in the U.S. increased by approximately 600% year-over-year in Q4 [81] Company Strategy and Development Direction - The company aims to leverage its financial strength to build the U.S. market, focusing on increasing consumer awareness and surgeon confidence in EVO adoption [6] - Plans for 2023 include doubling spending on EVO digital marketing campaigns and increasing sales and clinical personnel [6] - The company is committed to surrounding U.S. surgeons with clinical and sales support to integrate EVO into their practices [105] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the recovery of the China market, noting that refractive procedures are returning to normal levels [10][68] - The company anticipates a weighted sales calendar in 2023, with expectations for Q1 net sales to be between $65 million and $67 million [7] - Management remains optimistic about the U.S. market potential, citing strong commitments from larger customers and increased surgeon engagement [32][68] Other Important Information - The company generated $35.7 million in cash from operations in fiscal 2022 and ended the year with over $225 million in cash and investments [35] - For fiscal 2023, the company expects R&D expenses to be approximately $11 million each quarter, focusing on post-approval studies and quality [8][103] Q&A Session Summary Question: What is the outlook for the China market? - Management expressed confidence in the China market, noting no travel restrictions and a return to normal refractive procedures [10] Question: Can you elaborate on the U.S. EVO launch and practice development efforts? - The company is increasing its infrastructure and support for U.S. surgeons to enhance EVO adoption [22][105] Question: How significant was the backlog of procedures in China due to COVID? - Management indicated that the backlog is being addressed, with confidence in meeting projections for the year [15][43] Question: What are the expectations regarding FDA proposals for LASIK patient disclaimers? - Management stated that they cannot predict the timing of FDA decisions but emphasized that EVO's clinical trial data has already been approved [44] Question: How is the company addressing price competition in the U.S.? - Management clarified that price is not a factor in their growth strategy and they do not plan to use promotions to spur demand [28][102]

Financial Data and Key Metrics Changes - Total net sales for Q3 2022 were $76 million, up 30% compared to $58.4 million in Q3 2021, with a 33% increase in ICL sales, representing 95% of total net sales [20][28] - Gross profit was $60.5 million or 79.5% of net sales, compared to 77.6% in Q3 2021, reflecting a 190 basis point year-over-year increase [23] - Operating income was $13.7 million or 18% of net sales, compared to $7.8 million or 13.4% in Q3 2021 [27] Business Line Data and Key Metrics Changes - Global ICL unit growth was up 40% year-over-year, with significant growth in the U.S. (63%), China (52%), Japan (40%), and South Korea (49%) [9][13] - ICL sales are anticipated to be approximately $272 million for fiscal 2022, representing 28% year-over-year growth [10] Market Data and Key Metrics Changes - In China, the company expects to exceed a 25% share of the refractive surgery market units by year-end, despite COVID-related delays [10] - The U.S. market is projected to see unit growth accelerate to approximately 100% year-over-year in Q4 2022 [18] Company Strategy and Development Direction - The company is focusing on the growth opportunities with its premium EVO products while phasing out its low-margin other products business [11][19] - STAAR aims to achieve approximately 30% ICL sales growth year-over-year to approximately $355 million in total company net sales for fiscal 2023 [12][32] Management's Comments on Operating Environment and Future Outlook - Management highlighted challenges such as tighter COVID restrictions in China and macroeconomic headwinds in Europe but remains optimistic about growth in the U.S. and Asia [10][12] - The company anticipates a strong trajectory of growth for EVO ICL and continued market share gains in 2023 [19][32] Other Important Information - The company has trained over 550 U.S. surgeons on EVO lenses and expects to exceed its goal of training 600 by the end of 2022 [16][18] - STAAR has implemented an investment policy to maximize returns on cash, resulting in a cash balance of $224.7 million as of September 30, 2022 [29][30] Q&A Session Summary Question: What are the headwinds affecting the Q4 implied outlook? - Management identified approximately $5 million in delayed revenue due to COVID lockdowns in China, $2 million from European macroeconomic factors, and $1.5 million from foreign exchange impacts [38] Question: What is the expected growth in China for 2023? - Management expects unit growth in China to exceed 30% in 2023, despite lingering COVID headwinds [41] Question: How is the U.S. market performing? - The U.S. market is expected to see strong growth, with management projecting significant market share gains within 18 months [42] Question: What is the impact of the phase-out of other products on ICL use? - Management does not anticipate a negative impact on ICL use due to the phase-out of other products, as they will continue to support customers during the transition [57] Question: How does the company expect to achieve the $355 million target for 2023? - The target includes a mix of unit growth and pricing, with expectations for a healthy average selling price in the U.S. [72]

Form 10-Q (Mark One) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2022 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 0-11634 STAAR SURGICAL COMPANY (Exact Name of Registrant as Specified in its Charter) (Registrant's Telephone Number, Including Area Code) Securities registered ...

Financial Data and Key Metrics Changes - Total net sales for Q2 2022 were $81.1 million, representing a 30% year-over-year increase from $62.4 million in Q2 2021 and a 28% increase sequentially from Q1 2022 [29] - ICL sales accounted for 96% of total company net sales, similar to the previous year [30] - Gross profit for Q2 2022 was $63.9 million, or 78.8% of net sales, compared to 78.9% in Q2 2021 [33] - Net income for Q2 2022 was $13 million, or $0.26 per diluted share, compared to $8.6 million, or $0.17 per diluted share in Q2 2021 [41] Business Line Data and Key Metrics Changes - Global ICL unit growth was up 42% year-over-year, with significant growth in various regions: China (up 45%), the U.S. (up 36%), Japan (up 41%), India (up 181%), and Asia Pacific distributor markets (up 66%) [15] - The company reaffirmed its fiscal 2022 net sales outlook of approximately $295 million, despite currency headwinds [26] Market Data and Key Metrics Changes - The U.S. market showed strong adoption of the EVO family of lenses, with over 400 surgeons trained and certified, aiming for at least 600 by year-end [22] - In China, the company reported a strong busy season for EVO procedures, with effective management of COVID-19 related challenges [17] Company Strategy and Development Direction - The company is focusing on expanding its EVO lens offerings and enhancing brand awareness through partnerships with influencers, such as Joe Jonas [12][20] - Plans to showcase the EVO family of lenses at major industry events, including the European Society of Cataract and Refractive Surgeons Congress [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about navigating current COVID-19 challenges and meeting anticipated demand levels [17] - The company expects to continue seeing robust ICL unit growth and has adjusted its outlook for the second half of the year to account for currency impacts [32] Other Important Information - The company received its five-year MDR Certification from the European Notified Body, DEKRA, highlighting its commitment to quality [13] - The company plans to participate in several investor conferences and events in the coming weeks [45] Q&A Session Summary Question: Impact of influencer partnerships on sales trajectory - Management indicated that launching with a major influencer typically results in increased interest and a significant bump in sales, with expectations for a strong campaign rollout in the U.S. [48] Question: Long-term market share growth in China - Management confirmed a commitment to expanding distribution and partnerships in China, with a focus on both large and smaller clinics [50] Question: U.S. revenue impacts from inventory reserves - Management clarified that the reserve taken on the old Visian product did not impact revenue but was reflected in the cost of goods [56] Question: Surgeons' training and adoption rates - Management noted that the training of surgeons is progressing well, with expectations for continued growth in adoption rates for EVO lenses [82] Question: Pricing and ASPs in different markets - Management acknowledged that ASPs are expected to increase as the U.S. market grows, despite lower ASPs in China due to competitive pricing [75] Question: Gross margin expectations amid inflation - Management indicated that operational efficiencies are helping to maintain gross margins despite inflationary pressures [89]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: July 1, 2022 Or (626) 303-7902 (Registrant's Telephone Number, Including Area Code) Securities registered pursuant to Section 12(b) of the Act: (State or Other Jurisdiction of Incorporation or Organization) 25651 Atlantic Ocean Drive STAAR SURGICAL COMPANY Lake Forest, California 92630 ☐ TRANSITI ...

STAAR Surgical Company (NASDAQ:STAA) Q1 2022 Earnings Conference Call May 4, 2022 4:30 PM ET Company Participants Brian Moore - Vice President, Investor, Media Relations and Corporate Development Caren Mason - President and Chief Executive Officer Patrick Williams - Chief Financial Officer Conference Call Participants Bill Plovanic - Canaccord Zach Weiner - Jefferies Ryan Zimmerman - BTIG Chris Cooley - Stephens Andrew Brackmann - William Blair David Saxon - Needham Disclaimer*: This transcript is designed ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: April 1, 2022 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 0-11634 STAAR SURGICAL COMPANY (Exact Name of Registrant as Specified in its Charter) (State or Other Jurisdiction of Incorporation or Organization) 25651 Atlantic O ...

Financial Data and Key Metrics Changes - Total net sales for Q4 2021 were $59 million, up 28% compared to $46 million in Q4 2020 and up 1% sequentially from Q3 2021 [19] - Gross profit for Q4 2021 was $45 million, or 76.3% of net sales, compared to $34.3 million, or 74.6% of net sales in Q4 2020 [22] - Net income in Q4 2021 was $4.9 million, or $0.10 per diluted share, compared to $3.3 million, or $0.07 per diluted share in Q4 2020 [29] Business Line Data and Key Metrics Changes - ICL sales represented 90% of total company net sales for Q4 2021, up from 87% in the prior year quarter [21] - ICL unit growth for fiscal 2021 was up 48% year-over-year, significantly outpacing the 17% increase in global industry refractive procedures [10] Market Data and Key Metrics Changes - ICL unit growth in various markets for Q4 2021 included China up 44%, Japan up 45%, South Korea up 35%, India up 74%, and Latin America up 30% compared to the prior year quarter [11] - The U.S. is estimated to have 100 million adults aged 21 to 45 who are potential candidates for implantable Collamer lenses [15] Company Strategy and Development Direction - The company plans to invest more heavily in consumer awareness programs to accelerate the shift to lens-based vision correction [15] - STAAR aims to triple its manufacturing capacity within the next 18 months to meet growing demand [57] Management's Comments on Operating Environment and Future Outlook - Management reaffirmed the fiscal 2022 net sales outlook of approximately $295 million, representing 28% year-over-year growth [13] - The company expects to return to a more normal pre-pandemic sales calendarization in 2022, with approximately 48% of net sales in the first half of the year [20] Other Important Information - The company anticipates a gross margin of approximately 77% for Q1 and full year 2022, with investments in manufacturing facilities [23] - Capital expenditures for 2022 are expected to be approximately $20 million, primarily for manufacturing expansion [31][76] Q&A Session Summary Question: Update on discussions with the FDA - Management is in customary interactive review with the FDA and feels confident about a positive result for their submission [36] Question: Impact of the Olympics on branding opportunities in China - Management noted strong orders from surgeons in China and attributed growth to effective social media and digital marketing efforts [37] Question: Current backlog status and its impact on guidance - Management confirmed a healthy backlog and indicated that some of it is factored into the 2022 guidance, with strong current orders providing an opportunity to overperform [42] Question: Capacity and supply chain issues - Management is working to triple current capacity within 18 months and aims to have reserve inventory capability of 30% to 40% of projected demand [57] Question: Tax rate expectations for 2022 - The anticipated tax rate for 2022 is approximately 30%, influenced by the geographical mix of profitability [77] Question: Continuation of COVID impacts on guidance - Management has taken potential COVID-related headwinds into account but remains optimistic about a strong start to 2022 [82] Question: FDA requirements for manufacturing expansions - Management explained that some expansions require inspections while others may only need notification, depending on regulatory requirements [87]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 0-11634 STAAR SURGICAL COMPANY (Exact name of registrant as specified in its charter) Delaware 95-3797439 (Registrant's telephone number ...