Establishment Labs Holdings Inc.

Good afternoon.

Welcome to Establishment Labs' first 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 lines for a question and answer session, and instructions will follow at that time. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, today's call is being recorded. I will now turn the call over to Raj Dhanoy, Chief Financial Officer Thank you. Please go ahead. Thank you, Operator, and thank you, everyone, for joining us. With me today is Juan Jose Chacon-Quiros, 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 certainties 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. 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 content of this conference call contains time-sensitive information, accurate only as of the date of this live broadcast, May 9th, 2022. Except as required by law, Established 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 first quarter of 2022 totaled $38.5 million, a 27% increase over the first quarter of 2021. This is a new quarterly record for our company. Our singular focus on developing highly differentiated technologies based on science and patient-centric design with far superior clinical results, continues to be the key for our market share gains, and we expect these gains to continue. Most importantly, our innovations are aimed at creating new categories and markets that will help sustain our growth far beyond the current market as we know it today. We see a future of women empowered with abundant new options. Raj will provide additional detail on our first quarter performance and our outlook in a moment. Before I turn the call over to him, I would like to highlight several recent events. The past several weeks have seen two seminal events in our company's history of improving women's health. The first of these was the presentation of two-year data from the primary augmentation cohort of our U.S. IDE clinical study. The data was presented by Dr. Caroline Glixman, the principal investigator in the study at the aesthetics meeting in San Diego on April 22nd. As impressive as the sub 1% rates of capsule contracture and rupture at two years are in the US study, they mirror the results we have seen over the past 11 years with the over 2 million Motiva implants in market. The results are another confirmation that the performance we have seen across real-world data and numerous studies with Motiva is absolutely creating a new standard in breast aesthetics and reconstruction. Motiva implants have changed what surgeons and women should expect from breast implants. I think the preliminary data should be cause for optimism that we are in a position to take a very meaningful share of the United States market. This has certainly been true in every single market that we have entered, and we are now in more than 80 markets. Estimates have the United States making up about 40% of the world market with premium pricing compared to other geographies. So our success in the US will obviously very, very important for a company. I think the optimism should extend past our ability to take market share though. We have proven that again and again over the past 11 years. I think the question now is not that we can take continued market share in the United States and abroad. but how much can we grow the market itself? More than ever before, women are doing extensive research on their own before making choices in breast aesthetics and reconstruction. As women are presented with markedly improved safety data and the possibility of results that mirror their goals, we believe this market may be multiple times larger than it is today. The second seminal event is the financing we secured with our new lending partner, Oaktree Capital, on April 26th. We've gotten to know the team at Oak Tree over the past few months and we believe they share our passion for science and innovation and have a deep understanding of our strategy and the growth prospect in front of us over the next decade. This financing fully funds our innovation-driven business model and we can reach cash flow break-even even as we invest in new markets and develop new technologies. With this investment, our business is on very solid financial footing. As you may have noted with the two-year data from our study, we continue to move forward with our modular PMA submission with the FDA. We remain in active discussion with the FDA and I'm pleased to announce we have submitted our second module to the agency for review. We also remained on schedule to complete the remaining implants in the reconstruction cohort of the trial. And we expect to have this final cohort of the trial complete during the month of May. We will provide additional updates over the coming months on our progress towards launching our Motiva implants into the United States. 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. 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. Surgeons are adopting our technology, with many making it their expander of choice. We continue to win tender contracts in Europe and are expanding into new markets this year. 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, 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 MotivaMia, our minimally invasive breast enhancement procedure, we continue to perform new cases as well as track the original 100 patient cohort we completed in April of last year. 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 bring in a new base of consumers. We plan to provide an update on these patients soon. Regulatory clearance in Europe for the tools that are part of the Motiva Mia system are ongoing and we continue to plan to perform our first cases in the first half of 2022. According to our market research, the new category created by MIA could grow to more than 5 billion globally, with approximately half of the opportunity from new patients that had not previously considered a breast augmentation. Our clinical and commercial efforts in China are ongoing, and we continue to make progress in the regulatory process. Our expectation remains to obtain regulatory approvals for Motiva in this significant market by the end of the year. Finally, we continue to work on the transition in the European Union from the medical device directive to the new medical device regulations, a process which is expected to be finalized over the next few months. I will now turn the call over to Raj to cover our financial results.