Establishment Labs Holdings Inc.

Good afternoon, and welcome to Establishment Lab's second quarter 2022 earnings call. At this time, all participants will be in a listen-only mode. At the end of this call, we will open the line for a question and answer session, and instructions will follow at that time. As a reminder, today's call is being recorded, and I will now turn the call over to Raj Dhanoy, Chief Financial Officer. Please go ahead, sir.

Thank you, Operator, and thank you, everyone, for joining us. With me today is Juan Jose Chacon Quiroz, our Chief Executive Officer. Following our prepared remarks, we'll take your questions. Before we begin, I would like to remind you that comments made by management during this call will include forward-looking statements within the meaning of federal securities laws. These include statements on Establishment Lab's financial outlook and the company's plans and timing for product development and sales. These forward-looking statements are based on management's current expectations and involve risks and uncertainties. For discussion of the principal risk factors and uncertainties that may affect our performance or cause actual results to differ materially from these statements, I encourage you to view our most recent annual and quarterly reports on Form 10-K and Form 10-Q, as well as other SEC filings which are available on our website at EstablishmentLabs.com. As a reminder, Establishment Labs received an investigational device exemption from the FDA for Metiva implants and is undergoing a clinical trial to support regulatory approval in the United States. We continually seek to expand the geographies in which our products are regulatory approved. Please check with your local authority for specific product availability. The content of this conference call contains time-sensitive information accurate only as of the date of this live broadcast, August 8th, 2022. Except as required by law, Establisher Labs undertakes no obligation to revise or otherwise update any statement to reflect events or circumstances after the date of this call. With that, it is my pleasure to turn the call over to our CEO, Juan Jose.

Thank you, Raj, and good afternoon, everyone. I hope everyone is healthy and continues to remain safe. Revenue in the second quarter of 2022 totaled $41.2 million, a 29% increase over the second quarter of 2021. This is a new quarterly record for our company. Excluding the negative impact of foreign currency changes, our growth in the second quarter would have been approximately 33%. Our strong market share gains continue to be driven by our singular focus on women's health and well-being. Our commitment to bring highly differentiated technology based on science and patient-centric design is wholly unique in our industry. Most importantly, with this commitment to innovation, we are expanding existing markets and creating new categories that will sustain our growth for many years to come. Raj will provide additional detail on our second quarter performance and our outlook in a moment. If I turn the call over to him, I would like to highlight several recent events. In July, we released our annual sustainability report. We think about sustainability a little differently at Establishment Labs. Our company was founded on the understanding that the legacy of our industry cannot be our future. We are defined by our commitment to offer clinically safer and better options to women in their journey of breast health and wellness. Sustainability at its core is key to our continued growth and success. We recognize how privileged we are to lead the transformation of this industry through our commitment to women's health. We are focused on a future that is built on positive social and environmental practice. Most importantly, it is about the women who put their trust in us by choosing Latiba. By honoring this trust, we believe our business is on a strong foundation and our strong financial results are sustainable. Dr. Caroline Glixman, the principal investigator in our USID study, presented the two-year data from the primary augmentation cohort of the study in April. The results matched the exceptional performance we have seen over the past 11 years with the over 2 million Motiva implants we have sold around the world. We continue to receive very positive feedback on the results, and the interest it has sparked in the clinical community is tangible. As we announced last week, we have completed the remaining surgeries in the reconstruction cohort of the trial. Our USID study is now fully enrolled and we are moving diligently through follow-up. On the aesthetic cohort, as we've previously communicated, we are pursuing a modular PMA submission path. I'm pleased to announce we have submitted the third module to the agency for review. This module is related to the manufacturing of our implants. We look forward to submitting the fourth and final module to the FDA in the fourth quarter. In our aesthetic breast recon franchise, the launch of our Motiva Flora tissue expander in Europe and other CMR countries is ongoing. Flora has many advances over other commercially available tissue expanders, including a first-of-its-kind RFID-enabled port. which allows for MRI imaging without artifacts during the time an expander is used after a mastectomy. By being non-magnetic, FLORA potentially opens new options for radiation oncology treatment during this stage of recovery. FLORA also features our patented cell-friendly smooth silk surface technology, and early users have noted improved patient comfort and healthier capsule formation with this unique tissue expander. We are expanding the markets in which FLORA is available. Adoption will take time, but early efforts have been encouraging and add to our belief that we can help support women in their breast reconstruction journey. Surgeons are adopting our technology, with many making FLORA their expander of choice. FLORA is only the first step in our static breast recon initiative, where establishment labs will offer tools and techniques that allow women to receive reconstructive surgeries that achieve the aesthetic ideals to which they aspire and work to democratize breast reconstruction worldwide. We look forward to sharing more with you on these efforts in the future. In our consumer franchise, Mia, our minimally invasive injectable breast enhancement procedure, we continue to wait for regulatory clearance in Europe for the tools that are part of the Motiva Mia system. The migration in Europe from the MDD to the MDR standard has created some gaps in regulation for the industry, and this is adding to the regulatory timelines. As we wait for clarity, we continue to build our direct-to-consumer capabilities centered in our Women's Health Hub in Barcelona. We also continue to perform new MIA cases, as well as track the original 100-patient cohort we completed in April of last year. We have 100% follow-up on this first group of patients and the outcomes continue to support our belief that this approach will transform breast aesthetics and bring a new base of customers. Training of new surgeons in anticipation of our commercial launch is set to expand in the coming months. Overall, our early experience continues to support what we found in our market research, namely that the new category created by Nia could grow to more than 5 billion globally, with approximately half of the opportunity from new patients that had not previously considered a breast enhancement. Our clinical and commercial efforts in China are ongoing, and we continue to make progress in the regulatory process. Based on the updated expectations for the timing of regulatory review, given the effects of COVID-related restrictions in China, we expect approval for Motiva in this market in the first half of 2023. I will now turn the call over to Raj to cover our financial results.