Establishment Labs Holdings Inc.

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to the Establishment Labs Third Quarter 2021 Earnings Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. Should you require operator assistance during the conference, please press star zero to signal an operator. Please note this conference is being recorded. I will now turn the conference over to your host, Raj Denhoi, Interim CFO for Establishment Labs. Thank you. You may begin.

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 with 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 quarterly reports on Form 10-Q and 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 Mativa 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, November 9th, 2021. Except as required by law, establishment labs undertakes no obligation to revise or otherwise update any statement to reflect events or circumstances after the day of this call. With that, it is my pleasure to turn the call over to our CEO, Juan Jose.

Thank you, Raj, and good morning, everyone. I hope everyone is healthy and continues to remain safe. Revenue in the third quarter of 2021 totaled $29 million, a 28% increase over the third quarter of 2020. The continued momentum in our business allowed us to deliver strong sales results again, even though the third quarter is seasonally slower in a number of our major markets. Our singular focus on women's health Innovation in a track record of over 10 years of excellent clinical and aesthetic outcomes with Motiva implants continues to be the key for our market share gains and overall market growth. We are raising our full year guidance for 2021 to a range of $124 to $128 million. This is an upward revision from our previous guidance of $122 to $126 million. This updated outlook represents growth of 46% to 51% over 2020 and 38% to 43% over 2019. This guidance captures our high level of confidence in our business. We continue to see healthy underlying market demand and are taking market share in geographies around the world. While the pandemic continues to create some unusual quarter-to-quarter volatility, we are confident that our market share gains and strong results will continue. Raj will provide additional detail on our third quarter performance and updated outlook in a moment. Before I turn the call over to him, I would like to highlight several recent events. I wanted to start by updating everyone in the series of important developments that took place over the last couple of weeks. In October, we received notice from the FDA that the agency had reviewed and agreed to our modular PMA submission shell for the aesthetic cohorts of our US clinical trial. This agreement allows us to begin submitting to the FDA the four modules needed to support approval of our Motiva implants in the United States. I am delighted to report that last week we have submitted the first module of our PMA to the FDA. This first module covers the chemical characterization, toxicology, and biocompatibility of Motiva implants. While there is still a lot of work ahead of us, this is an important milestone on our path to U.S. approval. As a reminder, in August of this year, the aesthetic cohorts passed the two-year mark, and we continue to track these patients with excellent follow-up. We also closed our revision reconstruction cohort earlier this year. and are still actively enrolling patients in the remaining reconstruction cohort of the trial. We will provide additional updates over the coming months on our progress towards launching our Motiva implants into the United States, which remains the largest market for breast aesthetics and reconstruction in the world. As a company committed to women's health, we devoted the month of October, which is Breast Cancer Awareness Month, to support efforts around the world to create awareness and education and to help women in their breast reconstruction journeys. We directly supported more than 40 different campaigns worldwide across five continents. The campaigns looked to increase awareness and focused on education about breast cancer, including breast self-exam best practices and options for treatment and recovery. We also directly supported three breast reconstruction initiatives in partnership with over 100 plastic surgeons. These programs helped more than 300 women receive breast reconstruction surgery. These campaigns included donations and financial support and were carried out in partnership with hospitals, clinics, doctors, federations, distribution partners, and other essential stakeholders for establishment labs. We also conducted a breast health campaign among our employees in our different sites across the world. As an example of these efforts, on October 2nd, we held our first Motiva Breast Health Day at the Sant Pau Hospital in Barcelona. The day was devoted to women sharing their experiences with breast reconstruction as part of their breast cancer recovery. We plan to host similar events in other cities as part of our efforts to expand access to breast reconstruction. Our Pink is for Power campaign was dedicated to sponsoring post-mastectomy reconstruction procedures for women that could not access them. In Brazil, 245 women took part in the program this year. That is 245 women who were able to receive a reconstruction after waiting up to a decade after their mastectomy. We expanded the program into other countries this year, including Mexico, Colombia, Poland, and Korea. and we'll continue to build on this important initiative. At Establishment Labs, supporting improved access and providing the tools needed to improve outcomes in breast reconstruction are core to our mission as a women's health company. We believe our efforts and innovations in partnership with breast reconstruction surgeons can create new standards in post-mastectomy care and further transform breast cancer into a treatable disease from which women can fully recover. An important first step for us is our Motiva Flora Tissue Expander. On September 2nd, we held an event at the London Breast Meeting marking the official launch of Flora in Europe and other CE-marked countries. Flora has many advances over other commercially available tissue expanders, including the first-of-its-kind RFID-enabled port, which allows for MRI imaging without artifacts during the time an expander is used after mastectomy. By being non-magnetic, FLORA potentially opens new options for radiation oncology treatment during this stage of recovery. FLORA also features our cell-friendly smooth silk surface technology, and several early users at the symposium in London noted improved patient comfort and healthier capsule formation with the expander. Reconstruction surgeons understand the differentiation of the FLORA tissue expander, and we are already seeing regular use in key hospitals in Europe. As the advantages of FLORA become more widely known, we are seeing more and more requests for our expander, including for us to participate in government tender programs. While we have high expectations for the share we can take with the FLORA tissue expander in the existing reconstruction market, 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. We look forward to sharing more with you on these efforts over the next few months. In October, we announced the launch of JOY, our new premium patient-centric breast aesthetics program. Joy includes our Motiva Ergonomics II implants, which were designed based on the overwhelming success of our ergonomics platform that has seen over 700,000 implants sold since being launched in 2015. The ergonomic design of these implants introduced a new dimension to breast aesthetics based on new patient comfort and natural tissue-like characteristics. Ergonomics II continues this evolution with improved chemical and mechanical properties in our unique super silicones, making them 45% softer and 23% more adaptable, all of which we believe will result in even greater patient satisfaction. Joy also offers the Motiva Women's Choice Program. This first-of-its-kind program allows women with joy to receive financial support from establishment labs should they choose to have their implants removed for any reason subject to the program terms. As part of this program, participating surgeons may agree not to charge any additional fees for this procedure. Joy is the foundation for a new digital model that speaks directly with women considering breast surgery with online interactive tools, and we encourage you to experience it for yourself on our motiva.health website. Early interest in joy has exceeded our expectations, with women proactively reaching out to surgeons in countries all over the world inquiring about when and how they can get joy. On MotivaMia, our minimally invasive breast enhancement procedure, we continue to perform new cases as well as tracking the original 100 patient cohort we completed last April. We have 100% follow-up on this group of patients and the outcomes continue to support our belief that this approach will transform breast aesthetics and significantly expand the market. According to our market research, this new category could grow to 5 billion, which approximately half of the opportunity from new patients that had not previously considered a breast augmentation. Regulatory clearance in Europe for the tools that are part of the Motiva MIA system remains on track and should allow for a planned launch in 2022. Our clinical and commercial efforts in China are ongoing and we continue to make progress in this regulatory process. Our plan is to launch Motiva in this fast-growing market in the second half of 2022. In the third quarter, we also published the latest update to our corporate sustainability review, which outlines our sustainability goals for the coming decade and the progress we are making to achieve them. The report includes a presentation of our company's value map, stakeholders, and materiality framework. We are particularly proud to have elevated women's health and well-being to a key materiality topic around which we organize our activities alongside environment, employees, social development, and governance issues. We also recently published our updated post-market surveillance data report, which now includes 11-year data on Motiva implants, as well as data from several country-level independent registries. The findings continue to show rates of capsular contracture of less than 1% with Motiva implants, and importantly, the rates are statistically equivalent in the submuscular, subfascial, and subglandular positions. This is something that is not seen with legacy implants, and again shows that our technical innovations can have a meaningful impact on clinical outcomes and expands choices for both surgeons and patients. Lastly, I want to highlight a recent addition to the team at Establishment Labs. Jeffrey Bettinger recently joined as Global Head of People. We are building a strong and skilled team to scale our global operations as we prepare to enter new markets, as well as offer new direct-to-consumer programs. We look forward to his contributions as we build and inspire our organization for continued success. I will now turn the call over to Raj to cover our financial results.