Establishment Labs Holdings Inc.

Good morning and welcome to Establishment Labs second quarter 2021 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 Denhoi, Head of Strategy and Investor Relations. Please go ahead.

Thank you, Robert, and thank you, everyone, for joining us. With me today are Juan Jose Chacon Quiroz, our Chief Executive Officer, and Rene Gaeta, our Chief Financial Officer. Following their 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 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 10Q and other SECU 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 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, July 29, 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 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. I am pleased once again to be able to report a record quarter with 2021 second quarter revenue totaling $32 million. Second quarter revenue increased 205% over the second quarter of 2020 and was up 5% sequentially from the first quarter of this year. Our continued strong sales results show that a singular focus on women's health, innovation based on science, and a track record of over 10 years of excellent clinical and aesthetic outcomes with Motiva implants can drive significant share gains. It is not by accident that we remain on track to achieve the dominant share position in our industry. And as our story continues to resonate with surgeons, and most importantly, with women, we expect to continue to post strong results. With the strong momentum in our business, we are raising full year guidance for 2021 to a range of $122 to $126 million. This is an upward revision from the previous guidance of $118 to $122 million we provided with our first quarter results. This updated outlook represents growth of 44% to 49% over 2020. This updated guidance captures a continued momentum, including strong underlying market demand, and our capturing of share in geographies around the world. While the pandemic continues to create some unusual quarter-to-quarter volatility and more pronounced seasonality is a consideration over the near term in our business, we are confident that our market share gains will continue as countries open up thanks to vaccination campaigns all over the world. As always, and especially with the impact of COVID, we will continue to take a conservative approach to guidance. Renee will provide additional detail on our second quarter performance and outdated outlook in a moment. Before I turn the call over to her, I would like to highlight several recent events and provide an update on the key initiatives. On June 21st, a paper titled The Surface Topography of Silicon Breast Implant Mediates the Foreign Body Response in Mice, Rabbits, and Humans was published in Nature Biomedical Engineering. This paper was authored by a group of researchers at MIT and focused on determining the optimal breast implant surface that is most biocompatible and that induces the least amount of inflammatory response. The researchers were led by Professor Robert Langer, one of 12 institute professors at MIT and among the most published, cited, and decorated engineers in history. He is a scientific co-founder of Moderna, and on top of that, he has been cited over 326,000 times and is an author on more than 1,500 published articles. He was joined on the paper by a distinguished panel of researchers from MIT, MD Anderson, Johns Hopkins, Rice University, Baylor College of Medicine, the University of Manchester, and the Medical University of Innsbruck. The study showed that the patented Motiva smooth silk surface significantly reduces the foreign body response compared to implants with higher degrees of roughness or completely smooth surfaces. the researchers looked at the tissue capsules formed, as well as the expression of immune and inflammatory markers in both animal models and human tissue samples. The smooth silk surface was consistently shown to be in the sweet spot of inducing a healthy capsule, but also limiting the amount of inflammation. As Professor Langer said about the study, the smooth silk surface was superior in minimizing inflammation and excessive foreign body response. He went on to say that determining an optimal surface is a significant step for the medical device community towards designing safer and more biocompatible implants which can reduce patient complications. The importance of this paper is hard to overstate. Nature Biomedical Engineering is a well-recognized and respected journal in its field, and the Nature journals are among the most demanding in terms of their review process. The findings of this paper add more links to a change that spans from the inception of our Motiva implants over a decade ago and the technology we purposely designed into them to the consistently positive real-world outcomes seen by surgeons and patients who use them. It is not by accident that our implants consistently show excellent outcomes, and the work by Dr. Langer's team and others are adding to a body of evidence that is increasingly hard to ignore. The rigorous science and clinical data behind Motiva sets us apart from the competition, and our strong sales results show that this message is resonating more and more with surgeons and with women all over the world. On Motivamia, our minimally invasive breast enhancement procedure, we announced on April 27th the completion of our 100-patient Motivamia IRB-approved study in Costa Rica. We continue to perform cases that reaffirm our belief that this approach will transform breast aesthetics. As a reminder, Motivamia has the potential to make breast enhancement appealing to many women who previously had not considered breast aesthetics. The positive feedback from surgeons from different regions who have used the technology supports our view that MIA will expand our total addressable market. As a reminder, our initial estimate of the global total addressable market for MIA is 1.9 million procedures per year, which is larger than the current total market. 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. Motiva Flora, our novel tissue expander, has begun limited commercial sales. With a first-of-its-kind non-magnetic port, Flora allows for MRI imaging during the time an expander is used after a mastectomy. Flora has the potential to also improve clinical outcomes by changing the way women are treated for their cancer. By being non-magnetic, FLORA opens up a new paradigm for radiation oncology planning, and we have several projects and studies underway to help define how FLORA can improve cancer treatment during this critical stage in a woman's journey to recovery. FLORA is one part of a long-term strategy to make breast reconstruction not only safer, but also to create a new standard of what we call aesthetic breast recon. with the goal to provide similar outcomes for breast reconstruction and aesthetic patients. The clinical benefits that come from offering better alternatives is an important part of our women's health mission. In many countries around the world, less than 10% of women have breast reconstruction after a mastectomy, and there is a real opportunity to move this number meaningfully higher. Our ergonomics tool rollout continues in several select geographies. The Ergonomics2 platform builds upon our flagship ergonomics implant and offers enhanced mechanical properties, advanced chemistry, and improved ergonomics, all of which we believe will result in even greater patient satisfaction and justify a price premium. Our clinical and commercial efforts in China are ongoing, and we continue to make progress in the regulatory process. Our plan is to launch Motiva in this market in 2022. Our regulatory timelines for U.S. approval also remain unchanged. In August of this year, the aesthetic cohort will pass the two-year mark. We continue to enroll patients in the remaining reconstruction cohort of the trial, and as a reminder, we have fully completed the revision reconstruction cohort. Lastly, I want to highlight several recent additions to the team at Establishment Labs. In May, we announced that Prateep Dasidhar joined as head of global operations. He's also overseeing our digital transformation initiatives. Prateep's experience in transforming and scaling business processes at such companies as ServiceMaster, Salesforce, Amazon, HP, and others will be invaluable as we continue to expand our revenue base. In June, we announced that Nita Toprani joined as our general counsel and corporate secretary. She came to us from Zimmer Biomed, and I can tell you that her contributions and insights have already been significant in the short time she's been here. We also announced in June the hire of Heather Brennan as our head of U.S. commercial operations. She joins us from MTF, where she worked for the past 13 years, most recently as a general manager of their plastic and reconstructive surgery division. Heather is very well respected in our industry and among the plastic surgeon community. She's already deep into planning our strategy as we prepare to enter the U.S. market. Of course, as we announced earlier this month, this is Rene Gaeta's last earnings call with Establishment Labs. She's leaving us to pursue another opportunity closer to her home in California. We have appointed Rash Danahoy, our current head of strategy and investor relations, as interim CFO. Raj joined us in February from Jefferies, and his background and experience make him a natural choice to support our continued growth. He has a deep understanding of our business, and he shares my passion to transform our industry by focusing on women's health and wellness. I have enjoyed working with him the past few months and appreciate him taking on this important role in our company. I will now turn the call over to Renee to cover our financial results.