
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]