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STAAR Surgical(STAA) - 2022 Q2 - Quarterly Report
2022-08-10 20:15
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(STAA) - 2022 Q1 - Earnings Call Transcript
2022-05-04 23:17
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 ...
STAAR Surgical(STAA) - 2022 Q1 - Quarterly Report
2022-05-04 20:14
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 ...
STAAR Surgical(STAA) - 2021 Q4 - Earnings Call Transcript
2022-02-24 02:19
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]
STAAR Surgical(STAA) - 2021 Q4 - Annual Report
2022-02-23 21:21
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 ...
STAAR Surgical(STAA) - 2021 Q3 - Earnings Call Transcript
2021-11-04 01:18
Financial Data and Key Metrics Changes - Total net sales for Q3 2021 were $58.4 million, up 24% compared to $47.1 million in Q3 2020, exceeding the previous outlook of $57 million to $58 million [25][26] - Gross profit for Q3 2021 was $45.3 million, or 77.6% of net sales, compared to 74.1% in Q3 2020 [28] - Net income in Q3 2021 was $6 million, or $0.12 per diluted share, compared to $3.9 million, or $0.08 per share in Q3 2020 [35][36] Business Line Data and Key Metrics Changes - ICL sales represented 93% of total company net sales for Q3 2021, with other products accounting for 7% [27] - Global ICL sales growth was up 31% year-over-year, with expectations for Q4 to exceed 40% growth [26][24] Market Data and Key Metrics Changes - ICL unit growth by geography included: Japan up 44%, South Korea up 21%, India up 338%, Germany up 25%, European distributor markets up 22%, Middle East and North Africa up 242%, and the U.S. up 66% compared to the prior year quarter [16] - China remains the largest market, with distributor inventory levels drawn down to historically low levels to meet demand [11] Company Strategy and Development Direction - The company is raising its full-year fiscal 2021 net sales outlook to a range of $230 million to $231 million, representing over 40% year-over-year growth [24] - Strategic imperatives include increasing marketing investments in key U.S. cities and expanding engagement with surgeons [19][21] - The company plans to open an ICL Experience Center in California in the first half of 2022 to enhance surgeon training and marketing education [23] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in overcoming temporary supply chain challenges and anticipates catching up on backlog in Q4 and Q1 2022 [50][54] - The company remains optimistic about achieving a compound annual growth rate of over 25% from 2020 to 2022, despite the impact of COVID-19 [24][68] Other Important Information - Cash and cash equivalents as of October 1, 2021, totaled $196.2 million, up from $152.5 million at the end of Q4 2020 [37] - The company plans to participate in several upcoming investor events, including the Canaccord Genuity Virtual MedTech & Diagnostics Forum [38] Q&A Session Summary Question: Regarding the backlog of 20,000 lenses - Management confirmed that the majority of the backlog is related to China and estimated that it could represent at least $65 million in revenue for the quarter if shipped [42] Question: Timing for distributor restocking - Management indicated that replenishment of inventory in China is already underway and they are prepared for the next big season starting in January [45] Question: Supply chain issues and their impact - Management clarified that the supply chain issues were not exclusive to China but were managed effectively to meet critical demand [88] Question: Expectations for U.S. market penetration post-launch - Management aims to achieve at least 20% market share in the U.S. within two to three years post-approval [95] Question: Growth driven by refractive market versus conversions - Management stated that the refractive market grows in the mid-single digits, while the company is growing at least 25% plus, indicating market share gains [82]
STAAR Surgical(STAA) - 2021 Q3 - Quarterly Report
2021-11-03 20:16
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: October 1, 2021 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 ...
STAAR Surgical(STAA) - 2021 Q2 - Earnings Call Transcript
2021-08-05 02:57
Financial Data and Key Metrics Changes - Total net sales for Q2 2021 were $62.4 million, up 77% compared to $35.2 million in Q2 2020, and up 23% sequentially from Q1 2021 [26][34] - Gross profit for Q2 2021 was $49.2 million, representing 78.9% of net sales, compared to 69.4% in Q2 2020 [28] - Operating income in Q2 2021 was $10.7 million, or 17.2% of net sales, compared to an operating loss of $600,000 in Q2 2020 [33] - Net income for Q2 2021 was $8.6 million, or $0.17 per diluted share, compared to a net loss of $1.2 million in Q2 2020 [34] Business Line Data and Key Metrics Changes - Global ICL unit growth for Q2 2021 was up 79% year-over-year, driving net sales growth [11] - ICL sales represented 95% of total company net sales for Q2 2021, with other products making up 5% [27] - The year-over-year increase in net sales for Q2 2021 was primarily due to global ICL sales growth, which was up 93% [26] Market Data and Key Metrics Changes - In China, ICL unit growth was up 65%, while Japan saw a 95% increase, and South Korea experienced a 57% rise [11] - The U.S. market reported a 255% increase in ICL sales year-over-year [11] - The Middle East and North Africa saw a staggering 378% growth in ICL sales [11] Company Strategy and Development Direction - The company is focusing on premium lens-based business and greater revenue per procedure, anticipating a shift from laser vision correction to ICL [18] - STAAR is increasing its net sales outlook for the full year fiscal 2021 to a range of $227 million to $230 million, up from a previous outlook of $215 million to $217 million [24] - The company is preparing for broader commercialization of the EVO lens and continues to work on regulatory pathways for marketing approval outside of Europe [19][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth opportunities, citing a third-party research firm naming STAAR the fastest-growing company in ophthalmology [22] - The company remains mindful of ongoing COVID-19 challenges but is optimistic about continued demand for EVO lenses [23] - Management highlighted the importance of in-person trade shows and conferences for advancing commercialization strategies [20] Other Important Information - Cash and cash equivalents as of July 2, 2021, totaled $173.1 million, up from $152.5 million at the end of Q4 2020 [36] - The company plans to participate in several investor conferences in the coming weeks [37] Q&A Session Summary Question: Comments on the dynamics between laser vision correction and ICL in China and Europe - Management noted that ICL is gaining ground among moderate myopia patients, with studies supporting higher patient satisfaction compared to laser vision correction [42] Question: Expectations for revenue building for the U.S. launch of EVO - Management indicated strong enthusiasm from surgeons for the EVO lens and expects significant market share growth similar to past experiences in China [51][53] Question: Plans for training U.S. surgeons for EVO - Management confirmed that training materials and certification requirements are ready, and they do not foresee training as a limiting factor [92] Question: Impact of COVID variants on business in China and Japan - Management reported limited disruptions in China due to COVID, while Japan experienced a slight decrease in lens implants during the Olympics, but expects a return to normal [64] Question: Future of current Visian ICL lenses post-EVO approval - Management stated that current Visian ICL lenses will continue to be sold alongside EVO due to the advantages of the new lens [68]
STAAR Surgical(STAA) - 2021 Q2 - Quarterly Report
2021-08-04 20:13
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 2, 2021 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 Oc ...
STAAR Surgical(STAA) - 2021 Q1 - Earnings Call Transcript
2021-05-06 05:45
Financial Data and Key Metrics Changes - Total net sales for Q1 2021 were $50.8 million, up 44% compared to $35.2 million in Q1 2020 and up 10% sequentially from Q4 2020 [14] - Gross profit for Q1 2021 was $39.1 million or 77.1% of net sales, compared to $24.8 million or 70.4% of net sales in Q1 2020 [16] - Net income in Q1 2021 was $5 million or $0.10 per diluted share, compared to a net loss of $134,000 in Q1 2020 [20] Business Line Data and Key Metrics Changes - ICL sales represented 93% of total company net sales for Q1 2021, with strong growth across various regions [14] - Global ICL unit growth for Q1 2021 was up 54% year-over-year, with significant increases in China (up 63%), Japan (up 72%), and the US (up 46%) [6][14] Market Data and Key Metrics Changes - The company anticipates Q2 2021 net sales to be approximately 50% year-over-year revenue growth compared to Q2 2020 [14] - The US market is expected to see a significant introduction of EVO lenses pending FDA approval, with a planned launch in Q4 2021 [12][21] Company Strategy and Development Direction - The company is focusing on expanding its EVO Visian ICL family of lenses and enhancing direct-to-consumer outreach to build awareness [8][10] - A new advertising campaign featuring a Japanese celebrity aims to increase visibility and patient engagement in Japan [9] Management's Comments on Operating Environment and Future Outlook - Management views the current growth as a continuation of pre-COVID momentum, with expectations for sustained growth in the coming quarters [24][25] - The company anticipates total net sales for fiscal 2021 to be approximately $215 million to $217 million, representing over 30% year-over-year growth [13] Other Important Information - The company plans to participate in several upcoming conferences, including the Oppenheimer Medtech Tools and Diagnostic Summit [21] - The company expects to maintain gross margins in the mid-70% range for Q2 and the fiscal year 2021 [16] Q&A Session Summary Question: Source of growth and awareness - Management does not see the growth as a catch-up but as a continuation of momentum pre-COVID, with strong patient referrals and social media engagement driving awareness [24] Question: US and EU implant numbers - Management noted a significant uptake in Europe and the US, attributing it to prior efforts in building awareness and patient satisfaction [25]