Establishment Labs(US:ESTA)2023-02-27 23:50Financial Data and Key Metrics Changes - Record revenue in Q4 2022 totaled $43.8 million, a 24% increase over Q4 2021, with growth of approximately 28% excluding foreign currency impacts [15][24] - For the full year 2022, revenue totaled $161.7 million, a 28% increase over 2021, with a 32% growth rate when excluding currency changes [15] - The company provided revenue guidance for 2023 in the range of $200 million to $210 million, representing estimated growth of 24% to 30% over 2022 [16][37] Business Line Data and Key Metrics Changes - Direct sales accounted for approximately 37% of sales in Q4 2022, with distributor sales making up the remainder [24] - The rollout of the Motiva Flora tissue expander continues to receive positive market feedback, with increasing adoption among surgeons [18] Market Data and Key Metrics Changes - Sales distribution in Q4 2022: Europe approximately 28%, Asia Pacific and Middle East 40%, and Latin America the balance, with Brazil accounting for about 14.6% of total quarterly sales [25] - The company expects regulatory approval for Motiva in China in the first half of 2023, following the lifting of COVID restrictions [21] Company Strategy and Development Direction - Establishment Labs aims to create a new category in breast aesthetics with Mia, targeting women who prefer minimally invasive procedures [12] - The company is focused on improving breast reconstruction and democratizing access to these services globally, with a long-term revenue goal of $500 million by 2026 [22][50] - The new manufacturing facility is expected to more than double production capacity, allowing the company to meet over half of the current global demand [47] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving growth targets, citing strong momentum in the business and expected contributions from new initiatives like Mia in China [39][50] - The company is preparing for a busy 2023, with significant events including the commercial launch of Mia and the Motiva launch in China [41] Other Important Information - R&D expenses for Q4 2022 increased to $6.5 million, while total operating expenses rose to $41.3 million, reflecting investments in growth initiatives [26][32] - The gross profit for Q4 2022 was $28.2 million, or 64.3% of revenue, impacted by foreign currency fluctuations [33] Q&A Session Summary Question: Infrastructure for U.S. and Mia launch in Europe - Management discussed the unique business model for Mia, emphasizing partnerships with selected clinics rather than traditional sales reps [42][43] Question: 2023 guidance and contributions from Mia and China - Management clarified that the 2023 guidance does not include U.S. revenue, but expects contributions from Mia and China to build throughout the year [55][56] Question: Launch progress of Mia in Japan - Management confirmed the first clinic partner in Japan and highlighted the importance of demonstrating the new consumer base for Mia [70][71] Question: Gross margin expectations - Management indicated that while initial launches may be margin dilutive, overall gross margins are expected to improve over time due to new products and geographic expansions [76][80] Question: Regulatory environment and potential for faster approval - Management stated it is too early to predict the timeline for U.S. approval but remains focused on the regulatory process [97]