Juan Jose Chacon Quiros
Analyst · Jefferies. Please proceed with your question
Thank you, Jeremy, and good morning, everyone. Thank you for joining us today. We are, like everybody around the world, extremely concerned with the humanitarian and economic crisis caused by the spread of COVID-19, and we will certainly provide our thoughts on that today.First and foremost, we are working to protect the health of our employees and their families, and we are in constant communication with our partners and plastic surgeons worldwide to help our patients, however we can. While we grapple with the effects of COVID-19, it is still important to discuss the strength with which we finished 2019. The fundamentals that make our business strong in 2020 and the actions we are taking and can take to adapt as our industry and the world economy manage through this global challenge.Let us start by discussing our fiscal year 2019. During the fourth quarter of 2019, revenue was $24.2 million, an increase of 47.9% over the same period of 2018. For the year, revenue was $89.6 million, an increase of 46.3% over a full-year 2018. These financial results are towards the high-end of the preliminary revenue ranges we announced in a press release on January 28. And it is another record quarter made possible by the continued global adoption of Motiva Implants.Issuing full-year guidance for a high growth company like ours is challenging enough in a normal environment and an impossible task with a rapidly developing story of the novel COVID-19. Prior to last week, we were planning to issue formal guidance for 2020, but given world events, we are going to forego providing formal guidance today.To help our shareholders think about our 2020 year, we would like to give some visibility into our first quarter results. And as of today, we anticipate revenue to be in the range of $23 million to $25 million. Please remember that this is based on the best information we have today and that we have factor in a significant impact to our business from COVID-19 in March. Assuming a more normalized environment for first quarter call in May, we currently intend to issue formal guidance at that time.I'm speaking with surgeons daily, as do all of our commercial team members, and plastic surgeons have indicated that they continue to operate as long as there are no restrictions in place by their government. To date, most patients would schedule surgeries are having those surgeries performed. Surgeons are seeing some slowing, however, in medical tourism, South Korea, for example, does have a portion of patients that come from China as Motiva is not available in the Chinese market and we expect those surgeries to be impacted.If an increasing number of countries such as Italy need to mandate significant restrictions to get the spread of COVID-19 under control, that will obviously impact our business more. The fact that we are in more than 80 countries is very important as the world responds to COVID-19. The diverse nature of our revenue approximately 30%, Asia-Pacific and Middle East, 40% Europe, 30% Latin America should provide some level of protection to a revenue as different regions will likely grapple with the worst of the virus at different times this year.Of course, as I mentioned above, we are not reliant on China for any primary aspects of our supply chain. As we think about forecasting our business, I can tell you that our executive team has decades of experience in the breast implant industry. One of the core capabilities of our company is that we are agile and adaptable organization that has deep experience dealing with changing situations and environments. Disability is the reason Motiva Implants have taken a commanding position in such diverse markets such as Sweden, Colombia and South Korea.Further, our collective experience as a management team has taught us the following: woman interested in breast aesthetics go through an extensive, thoughtful and deliberate process. If they had put their surgery and an extraneous situation develops, they may very well reschedule or cancel their surgery. But most of these women will ultimately opt to have their procedure, once that situation has resolved.This has not only been true during previous severe economic downturns, it has been true even when there has been a significant and sustained negative news headlines about the breast implant industry. As this situation resolves, we currently believe that we will be positioned to maintain the growth trajectory that we experienced before this pandemic started.One of our growth initiatives has been to employ a multifaceted marketing strategy, which includes social media engagement, online advertising, and patient and physician education. We are taking this opportunity to optimize our digital media communication channels as a mean of supporting, training and communicating with our plastic surgeons and patients. We are also pleased to have completed a $69 million public offering in January. This gives us a very healthy cash position. When we are managing this very carefully, given all of these uncertainties.During the fourth quarter of 2019, we used $4 million to fund operations compared to $10.9 million for the third quarter of 2019 and $8.5 million for the fourth quarter of 2018. We have done a full review of our 2020 budget, and as this pandemic continues to develop, we are able to access a number of levers to reduce, reallocate or suspend our expenditures. We can continue to manage our business with lower cash burn well into the future on the path to breakeven in cash flow positive.Most importantly, the underlying fundamentals of our business remain strong and our product, brand and reputation in the market have significant momentum. We have a very healthy cash position, healthy gross margins, and we are in a position to take the necessary steps to come out of this period stronger than others in our industry.Turning now to the specific drivers of our Q4 performance. Our increased market share was again driven by balanced growth across all regions of the world, along with stronger sales of our ergonomics implants, which generally have higher average selling prices. Specifically, Australia and Colombia outperform in our distributor markets and Germany and France showed strength in our direct markets. We continue to see this strength across the different regions of the world and are not beholden to a single region to drive our continued success.The launch of our direct sales force across Europe and Brazil continued to positively impact our performance. Direct market revenue for the fourth quarter accounted for 45% of our total revenue as compared to 41% of our total revenue for the third quarter. Brazil was the strongest market in 2019. For the full-year, Brazil generated 15.7% of our total revenue. This was consistent with 2018, meaning that Brazil grew over 45% year-over-year, a testament to the success of our investments in commercial execution in the second largest global market for breast aesthetics.Additionally, as we previously announced, two of our new distributor markets last year were Taiwan and Thailand, with the latter being one of the largest aesthetic markets in Asia. These markets were strong in Q4 and into Q1 2020. Although we continue to monitor developments closely in Asia in light of the ongoing pandemic.Improvements in gross margins was another highlight of our fourth quarter and full 2019 results. Gross margins for the fourth quarter were 67.5% of revenues, which is a significant improvement over 60.2% of revenues in the fourth quarter of 2018. Gross margins for the full-year 2019 were 61.3% of revenues, compared to 59% of revenues for the full-year 2018.Geographic expansion is a key part of our long-term growth strategy as we work to become the global standard in breast aesthetics. While we expect the U.S. and China to be significant drivers of our long-term growth by tripling our total addressable market, it is worth noting that we have a significant opportunity for organic growth into more than 80 countries in which Motiva Implants are currently commercially available.Plastic surgeons continue to adopt our products in their practices as both surgeons and patients talk about the benefits of our improved safety and patient outcomes. Patient preference is one of the key drivers of our market share gains and we are continuing our efforts to reach out directly to potential patients.During the fourth quarter, we announced the 1 millionth Motiva Implant end market. Notably, this very significant milestone was achieved in only 10 years and with the complication rate of less than 1% for safety related events in our post-market surveillance, which we published quarterly.Capsular contracture and implant rupture are the two most common reasons for failure associated with breast implants. A peer reviewed retrospective study of 2,506 patients at up to 3 years reported complication rates with Motiva Implants, SmoothSilk of 0.36% and reported no cases of device related implant rupture. No cases of capsule contracture, no double capsules and no late seromas. We are happy to see more scientific proof and clinical papers in peer reviewed publications with evidence of the unique safety profile of Motiva Implants.Just in 2019 alone, we saw 11 papers published on Motiva Implants, further confirmation of the science behind our technology and the clinical outcomes that we have observed in our quarterly post-market surveillance since 2010. We expect more papers to be published in 2020, including additional papers on the scientific basis of our technology and why its unique characteristics result in substantially reduced safety related complications. Hands-on surgeon experience, patient feedback and these publications are creating a groundswell of interest in adoption of our products, and we believe the safety profile of Motiva relative to other implant products on the market is a driving force behind our continued growth in market share gains.Our regulatory efforts continue to progress with geographic expansion for our current product offerings and a path towards the approval of several new products. We have the most comprehensive portfolio of smooth implants worldwide and are continuing to build on these offerings.We previously announced a 510(k) submission for SmoothSilk tissue expander in the U.S and CE Mark registration in the EU. These submissions are important milestone for our company and the tissue expander represents a meaningful addition to our product portfolio. The advanced design of our tissue expanders should fuel adoption in the breast reconstruction market for all of our products. We continue to work through the approval process with the respective regulatory bodies as we work to finalize our launch strategy.As a reminder, our tissue expander is a substantial advance for the industry as it includes our proprietary SmoothSilk surface and is the only tissue expander with an integrated port with no magnets, enabling the use of the expanders safely alongside MRI scanning. This is real innovation that can make a substantial difference to oncologists, plastic surgeons and patients, and we'll have a real impact on women's health.Turning to our minimally invasive breast augmentation initiative for Motiva Mia, we began cases in Asia last December. Similar to the introduction of minimally invasive surgeries in other medical specialties, we believe that bringing a minimally invasive breast augmentation to market has the potential to grow the worldwide total addressable market for breast aesthetics. For the global plastic surgeon community, we are beginning to see a transition to smooth implants, which will take some time to complete.Textured and smooth implants have different surgical techniques and responsibly transitioning from one to the other does involve some education. We have taken this ongoing transition as another opportunity to provide our industry, both surgeons and patients with further scientific details and medical education about our surface technology. As we provide considerable medical education around the world, we believe the transition to smooth implants and more specifically, Motiva Implants with our proprietary SmoothSilk surface will accelerate.We are also dedicated to growing our intellectual property portfolio and are protecting the innovations that differentiate us from others in the market. Last year, we announced that the U.S. Patent Office allowed a key patent application covering our unique implant surface technology. We are pleased to announce today that the patent office will issue that patent within a few weeks. We will continue to dedicate resources to developing innovations that improve patient outcomes and protect those innovations with a robust IP portfolio.Turning now to our U.S clinical trial. We are progressing in our FDA pivotal IDE clinical trial for Motiva Implants. In August of last year, we announced the completion of all surgeries in the aesthetic cohort, and during the fourth quarter we continue to make progress advancing the reconstruction cohort. Importantly, our U.S. submission timelines for our PMA to the FDA remain on track due in large part to the bifurcation strategy that we discussed last quarter.In light of the fact that we were able to complete the primary augmentation revision augmentation cohorts, we intend to pursue submission for the aesthetic indications ahead of our submission for the reconstruction indications. Recent communications with the FDA give us further confidence in this bifurcation strategy and we continue to take the necessary steps in this process.With that, I'd like to turn the call over to Renee to discuss the financials in detail. Renee?