Establishment Labs Holdings Inc.

Good morning. Welcome to Establishment Labs' fourth quarter 2021 earnings call. At this time, all participants' line will be in 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. I will now turn the call over to Raj Dhanoi, Interim 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 that comments made by management during this call will include forward-looking statements within the meanings of federal securities laws. These include statements on Establishment Labs' 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 report 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 Motiva 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 authorities for specific product availability. The contents of this conference call contains time sensitive information, accurate only as of the date of this live broadcast, March 1st, 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 morning, everyone. I hope everyone is healthy and continues to remain safe. Revenue in the fourth quarter of 2021 totaled $35.3 million, 31% increase over the fourth quarter of 2020. full-year 2021 revenue of $126.7 million grew 50% over 2020. Our singular focus on women's health, the meaningful innovation we are bringing to our markets, and a track record of over 11 years of excellent clinical and aesthetic outcomes with Motiva implants continues to be the key for our market share gains, and we expect those gains to continue. Most importantly, our innovation centered on women's health are aimed at creating new categories and markets into the future. We are providing portfolio guidance for 2022 in the range of $155 to $165 million. This outlook represents estimated growth of 22% to 30% over 2021. This guidance captures the high level of confidence we have in our ability to take share in our existing markets and the early contribution of new products and new geographies that we expect over the course of the year. We continue to see healthy underlying market demand in our taking market share in geographies around the world where our products are sold. While the pandemic continues to create some volatility, we are confident that our market share gains and strong results will continue. 2022 looks to be another strong year for ESTA, as our science-based and consumer-centric innovations transform and expand the markets for breast aesthetics and reconstruction. Raj will provide additional detail on our fourth quarter performance in 2022 Outlook in a moment. Before I turn the call over to him, I would like to highlight several recent events. Earlier this year, we crossed a significant milestone in our journey of improving women's health. With our two millionth Motiva implant delivered to the market, it took nine years from when we first commercialized Motiva to deliver one million implants. And now, just two years later, we passed two million. While crossing two million implants is a commercial accomplishment we celebrate, we are most proud that women around the world are placing their trust in us by choosing Motiva. And this is not a trust we take lightly. A guiding principle from the day we founded our company is to put women first in all of our efforts. To this end, we constantly aim to be closer to our ultimate consumers, the women who receive our products, so we can best understand their needs and to provide support on their journey in breast aesthetics and reconstruction. The embodiment of these efforts is the Women's Health Hub we recently established in Barcelona. This hub will house our direct-to-consumer marketing teams, our European sales leaders, as well as our patient advocacy efforts all in one location. Locating these teams in the same office and having them in Europe, where we have direct selling efforts with Joy and soon with Nia, allows us to develop programs and initiatives that best meet the needs of women. An early example of what we can accomplish is the Joy program we launched last year. This first-of-its-kind program provides women with our latest generation Motiva Ergonomics II implants, as well as several other unique features and benefits. The Ergonomics II platform offers improved mechanical and chemical properties with our unique super silicones, making them 45% softer and 23% more adaptable, all of which we believe will result in even greater patient satisfaction. We believe they are the best implants ever designed and developed. With improved ergonomic characteristics, these implants are changing the consumer experience by providing more comfort in tissue-like look and feel. 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. Part of this program, participating surgeons may agree not to charge any additional fees for this procedure. The strong early interest we are seeing for Joy is an indication of the value that women see in the program, and our early commercial efforts suggest that this can translate into higher realized value for surgeons and for our company. Programs and offerings like Joy are a demonstration of what we can achieve by being close to the final consumer. And the new hub we have established in Barcelona will allow us to push these efforts even further when we launch the new category of minimally invasive augmentation with MotivaMIA and as we expand into new markets and geographies. On our last conference call, we updated everyone that we had submitted the first module of our PMA to the FDA. This first module covers the chemical characterization and biocompatibility of Motiva implants. Our modular PMA submission is still proceeding on track. We remain in active discussion with the FDA and are ready to submit the second module in the second quarter. As a reminder, in August of last year, the aesthetic cohort passed a two-year mark, and we continue to track these patients with excellent follow-up. We also closed our revision reconstruction cohort last year and are on schedule to complete the remaining reconstruction cohort of the trial in the next couple of months. We will provide additional updates over the coming months on our progress towards launching our Motiva implants into the United States. In September, we held an event at the London Press Meeting, marking the official launch of our Motiva Flora Tissue Expander in Europe and other CE-marked countries. Flora has many advances over other commercially available tissue expanders, including a first-of-its-kind RFID-enabled port. which allows for MRI imaging with our 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 cell-friendly smooth silk surface, and early users have noted improved patient comfort and healthier capsule formation with this unique tissue expander. Reconstruction surgeons understand the differentiation of the flora tissue expander, and we have already won several tenders in Europe. Adoption of flora 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. While we have high expectations for the share we can take with flora in the existing reconstruction market, flora is only the first step in our aesthetic breast recon initiatives. 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 with you more on these efforts in the future. 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, with approximately half of the opportunity coming 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 are ongoing and should allow for a planned launch in the first half of 2022. Our clinical and commercial efforts in China are ongoing, and we continue to make progress in the regulatory process. Our plan remains to launch Motiva in this fast-growing market in the second half of 2022. I will now turn the call over to Raj to cover our financial results.