Establishment Labs Holdings Inc.

Good afternoon. Welcome to Establishment Labs' third quarter 2022 earnings conference 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. Instructions will be given at that time. As a reminder, today's call is being recorded. I will now turn the call over to your host, Raj Denhoi, Chief Financial Officer. Please go ahead.

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 the 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 review 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. I'd also like to remind you that our comments will include certain non-GAAP financial measures with respect to our performance. including but not limited to sales results which can be stated on a constant currency basis. Reconciliation is the most directly comparable GAAP financial results can be found in today's press release which is available on our website. Please also note that Establishment Labs received an investigational device exemption from the FDA for Motiva implants 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 authorities for specific product availability. The content of this conference call contains time-sensitive information, accurate only as of the date of this live broadcast, November 7, 2022. Except as required by law, Establishment 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 third quarter of 2022 totaled $38.2 million, a 32% increase over the third quarter of 2021. Excluding the negative impact of foreign currency changes, our growth in the third quarter would have been approximately 38%. For 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 to the breast aesthetics and reconstruction markets based on science and patient-centric design is wholly unique in our industry. 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 third quarter performance in our updated outlook, including tightening our revenue guidance range to $158 to $162 million. But before I turn the call over to him, I would like to highlight recent events over the past several months. On Wednesday, October 5th, we presented an update on Mia Femtech, the new category we are creating in breast aesthetics. During the presentation, We showed an update on the clinical progress with Mia, our expectations for commercialization in a video of the procedure, as well as testimonials from women who have had the Mia procedure. If you haven't seen it, a recording of the webcast is available on our website, and I highly recommend taking the time to watch it. We are creating a new category in aesthetics for women that don't want a traditional breast augmentation, but are conscious about the shape and proportions of their breasts. MIA offers these women a minimally invasive procedure that can be performed without general anesthesia in less than 15 minutes with an easy return to their daily activities. The insights from the extensive consumer research we have completed show that many more women are interested in MIA than receiving a traditional augmentation today. In Japan, for example, our primary research showed 155,000 women are interested in MIA with 133,000 saying they are interested in getting the procedure in the next 12 months. Japan is a market where there are currently only about 5,000 traditional breast augmentations done every year. By providing a solution that is more appealing to consumers, we are opening up a whole new group of women to breast aesthetics. We plan to commercialize Nia in the first half of 2023. The recent regulatory updates out of the European Union on the common specifications around Annex 16 are encouraging, and our plans for market entry into Europe and other markets continue. We look forward to providing more updates over the coming months. As we announced in our second quarter call, all cohorts of our U.S. IDE study are fully enrolled, and we are moving diligently through the follow-up. On the ASTEC cohort, as we previously communicated, we are pursuing a modular PMA submission path. All patients in the cohorts pass the three-year mark in August, and we continue to expect we will submit the fourth and final module to the FDA this quarter. Now our aesthetic breast recon franchise, the launch of our Motiva Flora tissue expander in Europe and other CE mark 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 self-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 more, making FLORA their expander of choice. FLORA is only the first step in our Aesthetic 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. Our clinical and commercial efforts in China are ongoing, and we continue to make progress in the regulatory process. We continue to expect approval for Motiva in this market in the first half of 2023. Before I turn the call over to Raj to cover our financial results, I wanted to note the publication last month of our annual post-market surveillance report. which is available on our website. The report, which we update every year, highlights the clinical and safety performance of the 2.5 million Motiva implants in market over 12 years since we began commercialization in 2010. After more than a decade on the market, Motiva implants continue to show less than 1% device-related complications leading to re-operation, including capsule contacture and implant rupture. Also, we have no reported cases of squamous cell carcinoma, which was recently noted by the FDA. These unprecedented clinical results are supported by the science behind our implants. In late October, establishment labs attended the American Society of Plastic Surgeons meeting in Boston. We hosted a symposium for surgeons where Dr. Robert Langer from MIT presented the results from the paper he co-authored on the implant surfaces. The paper, which was published last year in Nature Biomedical Engineering, showed that our patented smooth silk surface produces the lowest rates of inflammation in the healthiest capsules compared to other commercially available smooth or textured implants. Scientific research, such as the work done by Dr. Langer and his lab, provides the answer as to why our implants perform better than others. There are now more than 50 peer-reviewed publications about Motiva, and we look forward to more seminal papers like Dr. Langer's over the coming months and years. I will now turn it over to Raj.