David Erickson
Analyst · experience in the medical device industry, and we are very pleased to have him on the team. David
Thank you, Juan José. Let me just quickly say how excited I am to be working with the management team here at Establishment Labs and I look forward to engaging with our analysts and shareholders in the days and weeks ahead.Moving on, our presenters on today's call are Juan José; and our Chief Financial Officer, Renee Gaeta. 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 involve material risks and uncertainties and the company's actual results may differ materially. For a discussion of Risk Factors, I encourage you to review our quarterly report on Form 10-Q that we plan to file with the SEC tomorrow and will be available on our website at establishmentlabs.com.The content of this conference call contains time-sensitive information accurate only as of the date of this live broadcast, May 7, 2020. 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's my pleasure to turn the call over to our Chief Executive Officer, Juan José Chacón-Quirós. Juan José?
Juan José Chacón-Quirós: Thank you, David, and good afternoon everyone. Thank you for joining us today. During these unprecedented times, our hearts go out to the families affected by this pandemic, and we applaud the health care workers and the other frontline responders for their selfless efforts to combat this crisis. As a women's health company, Establishment Labs is committed to helping our plastic surgeons and their patients around the world in whatever way we can.I'd like to take a moment to thank each of our employees, who have donated their time and resources to support local response efforts, while at the same time working tirelessly to help keep our operations running as smoothly and efficiently as possible given the current circumstances.In particular, I would like to acknowledge our employees in Costa Rica who have assembled and distributed several thousand protected face shields to the health care workers from the Ministry of Health and at local organizations who care for the elderly patients recovering from major illnesses and other at-risk individuals. I'd like to spend a few minutes discussing our first quarter performance, but I'm sure you're just as interested in how we expect COVID-19 to impact our outlook. So we'll provide you with as much information as we can to help frame the remainder of 2020.We are pleased to report that our first quarter sales were $24.5 million at the higher end of the $23 million to $25 million range we guided towards during our last earnings call. This reflects 18% growth over the year ago period as plastic surgeons and their patients continue to adopt Motiva Implants. Even though our March sales were measurably impacted by COVID-19, our first quarter still represented another record quarter for Establishment Labs and illustrates the strength and momentum of our product and brands in the market.Overall, sales in Q1 were strong, but as one would expect during the month of March and at different speeds across various geographies, we began to see a steep decline in breast enhancement procedures, as countries began to curtail non-essential activities including elective medical procedures. While most countries were shut down in April, procedures did continue in some countries, albeit at a greatly reduced rate. We are now seeing a number of countries begin to come back online.Procedures are resuming at varying rates of cross countries and it appears that those countries that faced COVID earliest and those who took aggressive steps to control its spread are coming back more quickly. It is also important to remember that the majority of breast enhancement procedures are not performed in hospitals, but in private clinics often which are owned or controlled by plastic surgeons. For this reason, we would expect a more rapid return to normal procedure volumes than you might see with other hospital-based elective procedures that compete for operating room time.As a reminder our revenue base is geographically diverse with sales in over 80 countries. Except for Brazil no single country represents more than 10% of our sales. While global diversity helps to spread risk, it also makes it extremely difficult to forecast 2020 sales accurately as each country has its own path on the return to normalcy. For this reason, we have decided to forgo providing full year sales guidance at this time. We are hopeful that as the global outlook becomes clearer, we will be able to provide guidance later in the year.Given the global impact of COVID-19, Q2 sales will be negatively impacted. However we are seeing evidence of conditions beginning to improve in certain geographies. And for this reason we do believe that we will sequentially see increases in Q3 and Q4 revenue. As we think about the balance of this year, it may be helpful to note that in Q2 we are seeing many procedures being rescheduled for the second half of this year rather than being canceled outright.This behavior seems consistent with the deep consideration we believe most women take when considering breast augmentation surgery. A research suggests that many women take several years to research breast augmentation exhaustively and once they have made a decision to proceed are very determined to follow through with their surgery. This has been true both through previous recessions and also when our industry has undergone a period of significant negative headlines.Our industry has been very resilient and this is very much a testament of how important this procedure is to women who choose to have it. In this unprecedented time our commitment to women's health and the unique safety profile of Motiva is resonating strongly with patients making a long-term decision to invest in themselves. We are seeing this determination play out once again.In Brazil, for example, our data shows that 76% of patients that chose Motiva Implants before the pandemic have decided to postpone not cancel their breast enhancement procedures. Even with the uncertainty around the speed of global recovery, we remain confident in the fundamentals of our business and the strength of our product portfolio, which up until now has resulted in robust year-to-year growth and market share gains. Our Executive team has decades of experience in breast aesthetics and reconstruction and we will navigate this turbulent time just as we have before.COVID-19 does not appear to have had much impact on women who are beginning their breast augmentation research as evidenced by the relatively steady rate of web searches and social media activity we are seeing.There is a slower pickup in women scheduling new face-to-face consultations and plastic surgeons are adapting by offering more online consultations and incorporating COVID-specific safety protocols for their patients and office staff. We have quickly converted our MotivaEdge in-person training programs and seminars to webinars online and have seen large increases in attendance. Some of these webinars have had over 1,000 registrants and nearly all of our events routinely attract at least several hundred participants.Plastic surgeons are taking this time to think about how they can improve their practices and learn about innovations in their field. And this is very much in line with Establishment Labs' message of innovation and presentations around the science of breast tissue management.Despite our long-term bullishness about the breast implant business, we have taken early and decisive steps to prepare our company to weather these uncertain times and position us for a strong recovery and further market share gains.Specifically, we have reduced our planned 2020 expenses by approximately 20% by eliminating unnecessary travel and non-essential discretionary spending, scaling back our manufacturing operations, lowering headcount, and temporarily reducing management employee compensation. Renee will provide greater detail about these actions in a few moments.While reducing certain expenses, we are also investing in strategic areas. For example, we are expanding our business excellence program from manufacturing to our entire global organization to enhance efficiencies and productivity as well as reducing waste.Since 2017, this program has generated over $5 million in cost savings including $1.7 million in 2019. With the new normal in 2020, we will be investing more resources in our digital footprint. Our digital marketing team is focused on initiatives to strengthen our social media presence and leverage other digital channels that provide valuable insight into patients seeking breast aesthetic procedures.We are also advancing with our plans to support plastic surgeons who are restarting their practices in select countries by linking them to patients interested in the improved safety and aesthetic outcomes of Motiva.Establishment Labs remains an entrepreneurial and agile organization that can adapt quickly to dynamic and complex environments. I believe that the combination of these actions will result in an even stronger company that is well-positioned for continued growth and success even as we navigate the uncertainty that has resulted from the COVID pandemic.Establishment Labs has the most comprehensive portfolio of advanced smooth implants worldwide and we are continuing to invest in our future by developing new products and entering new markets. Clinical trials of medical devices currently being studied in U.S. hospitals have understandably been impacted by COVID-19 as centers focus their energies on more critical needs.Although we continue to activate trial sites and secure IRB approvals, the pandemic has delayed enrollment in the reconstruction cohort of our Motiva pivotal trial, which could add at least six months to our timeline.As you already know, enrollment in our aesthetic cohorts was completed last year and we are presently in the follow-up phase. We are modifying our patient monitoring and follow-up plans according to the FDA's COVID-19 guidance and several of our sites in the U.S. are already conducting virtual consultations with patients as part of their follow-up protocol.As a reminder, roughly 80% of the U.S. breast implant market is comprised of aesthetic procedures. We continue to work towards our goal of receiving FDA approval for a Flora tissue expander. We still expect to receive a CE Mark for Flora and begin market development activities in Europe this year. We believe the proprietary features of Flora offer compelling advantages to currently available product and will be an important part of our product portfolio.Turning now to Motiva Mia our minimally invasive breast augmentation initiative we began proof-of-concept cases in Asia last December and we are very pleased with the results although COVID-19 has slowed the pace of additional surgeries.Surgeon and patient feedback has been positive and we are working to expand our initial patient series in additional countries. We continue to believe that the introduction of a minimally invasive breast augmentation procedure has the potential to grow the total addressable market for breast aesthetics and contribute to our long-term growth strategy. Later this year we are expecting the publication in a highly respected scientific journal of a groundbreaking study on the biocompatibility of our proprietary SmoothSilk Surface.This paper will add to the growing body of evidence in peer reviewed publications on the unique safety profile of Motiva Implants. Publications like this, combined with surgeon experience, and positive patient feedback, are key reasons for our success to date and should help drive continued market adoption and market share gains.Turning to other developments, during the quarter, we announced the issuance of a U.S. patent that protects the proprietary surface technology of our Motiva implants. We believe this innovative technology is one of the key aspects of the exceptional safety profile of Motiva and provides our company with a strong competitive advantage. We will continue to dedicate resources to developing innovations that improve patient outcomes and protect those innovations with a robust IP portfolio.Finally, we are pleased to welcome Rosalyn d'Incelli to our leadership team who will lead our clinical and medical affairs effort. Rosalyn who has more than 20 years of experience in the breast implant industry will initially focus her energy on our U.S. IDE for Motiva Implants.At approximately 50% of the global breast enhancement market, the U.S. represents a large growth opportunity for our company and we look forward to bringing our innovative Motiva round and ergonomic implants to women who seek outstanding aesthetic results.With that, I'd like to turn the call over to Renee to discuss the financials in detail. Renee?