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Dec 31, 2022
Establishment Labs Q4 2022 Earnings Report
Establishment Labs reported record fourth quarter financial results and submitted Module Four to U.S. FDA for Premarket Approval of Motiva.
Key Takeaways
Establishment Labs reported a record fourth quarter with worldwide sales of $43.8 million, a 24.1% increase year-over-year. The company submitted the fourth and final module to the U.S. FDA for premarket approval of Motiva Implants and provided 2023 revenue guidance of $200 million to $210 million.
Submitted fourth and final module to U.S. FDA for premarket approval of Motiva Implants®.
2023 guidance of $200 million to $210 million, an increase of 24% to 30% over 2022.
Fourth quarter worldwide sales of $43.8 million, a 24.1% year-over-year increase and a new quarterly record.
Cash balance of $66.4 million as of December 31, 2022.
Forward Guidance
Establishment Labs projects a groundbreaking year in 2023, aiming for $500 million by 2026, with revenue guidance of $200 million to $210 million.
Positive Outlook
- Commercial sales of Mia Femtech are progressing.
- Approval in China is expected in the first half of 2023, gaining entry into the second largest global market.
- Module four of modular PMA submitted to the U.S. FDA, bringing closer to approval of Motiva in the United States.
- New Sulàyöm campus will undergo validation and begin manufacturing this year, bringing significant new capabilities in R&D, medical education, and media.
- Defining what a women’s health company can do to raise the standards in breast aesthetics and reconstruction.
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