Joseph Hogan
Analyst · Goldman Sachs. Please proceed
Thanks, Shirley. Good afternoon, and thanks for joining us. On our call today, I'll provide some highlights in the fourth quarter and the full year, then briefly discuss the performance of our two operating segments, Clear aligners and intraoral scanners. John will provide more detail on our financial results, discuss our outlook for the first quarter and share our thoughts for 2019. Following that, I'll come back and summarize a few key points and open up the call to questions. Our fourth quarter was a strong finish to a great year. Q4 revenues were better than expected, reflecting higher Invisalign ASPs and volume growth of 31% year-over-year. As well as another record quarter for iTero scanners with revenue up 55% year-over-year. Q4 sequential growth was driven by a strong quarter for EMEA with record growth for teens as well as continued traction with Invisalign Lite and iGo. Q4 operating margin of 22.6% reflects higher doctor training and manufacturing costs as well as higher legal fees than anticipated, partially offset by sequential improvement in Invisalign ASPs. For the quarter, we trained a record 5,270 new doctors in Q4, which includes about 3,000 international doctors, of which, half were in EMEA and half were in APAC. For the year, we achieved record revenues of nearly $2 billion and had over 1.2 million people start treatment with Invisalign clear aligners for the first time, resulting in our 6 millionth Invisalign patient, a teenager from China. These results reflect record revenues and volumes for both Invisalign and iTero. Across customer channels and country markets and continued strength from teens, which grew 40%. The total number of teenagers treated with Invisalign this year was over 333,000, representing 27% of our volume. Finally, in 2018, we trained a record number of new Invisalign doctors, nearly 20,000 worldwide. And for the first time, more than half of them were international doctors. Now let's turn to the specifics around our fourth quarter results starting with the Americas region. For the Americas region, Q4 Invisalign case volume increased 21.7% year-over-year and was down sequentially off a record Q3 volumes, which benefited from strong uptake of promotions last quarter, predominantly by high-volume Invisalign doctors. On a sequential basis, Q4 reflects growth from the Americas GPs, offset by America's orthos, particularly high-volume doctors. Year-over-year growth for Q4 reflects continued adoption of Invisalign treatment from both orthodontist and GP channels, which were up 24.7% and 17.3%, respectively. We also saw good growth from our DSO partners across both GPs and orthos, up nearly 50% year-over-year. For the full year, Invisalign volume for the Americas region was up 24.2% compared to 2017. Americas orthos were up 27.2% and Americas GP dentists were up 19.8%, the second highest annual growth rate for orthos and the highest annual growth rate for GPs in 6 years. For Q4, we trained a record 2,290 new Invisalign doctors in the Americas region, of which, 1,725 were North American doctors and 565 were Latin American doctors. In total, we trained 7,885 new Invisalign doctors in the Americas in 2018, an increase of 19%. For international business, Q4 was a great quarter with Invisalign case volume up 12.2% sequentially, driven by strong growth in the EMEA region, offset somewhat by seasonality in the Asia Pacific region. On a year-over-year basis, strong Invisalign volume growth of 45.3% reflects increased utilization and continued expansion of our customer base in both EMEA and the Asia Pacific region. In Q4, we trained nearly 3,000 new Invisalign doctors internationally with roughly 50% in EMEA and 50% in APAC. In EMEA, Q4 was a strong quarter, up 42.7% year-over-year, driven by record Invisalign volumes in all country markets as well as strong growth in the teen segment, which is up 75.1% from the prior year, reflecting continued success of our Teen 360 program. For the full year, EMEA was up 38.6% led by Iberia, France and the U.K. as well as our key expansion markets led by Central and Eastern Europe. During 2018, we went direct in Turkey, Israel and Russia, adding to our expansion country markets. For APAC, Q4 was down sequentially as expected due to seasonality -- seasonally slower period in the region, up 49.3% year-over-year with record Invisalign volume in almost every country market led by China, Japan, ANZ. Q4 results reflect continued strong growth from teenage patients as well as adults, with GP dentists up 77.1% year-over-year. During Q4, we trained 1,530 new doctors in APAC, of which half were in China. We held several clinical education events across APAC designed to help increase doctor's confidence in adoption of Invisalign treatment, including how critical the iTero scanner is to practice growth. For the year, Invisalign volume from the international doctors increased 45% led by growth from China and our core EMEA country markets. In total, international volumes represented 41% of worldwide Invisalign case shipments. Despite our record results, we're still very clearly underpenetrated in APAC overall and specifically in China. As the second largest market for Align, China represents enormous growth potential, and our ability to expand and drive penetration across the region relies on our ability to be closer to doctors and their patients, communicate in local language and as much as possible, operate like a local company. Late in Q4, we began fabricating Invisalign aligners in our new manufacturing facility in Ziyang, China, our first aligner fabrication facility outside of Juarez, Mexico. There's a temporary facility that will be replaced by our own building in 2020. Over the next year, we will continue to build our manufacturing abilities in Ziyang and ramp up production to serve the rapidly growing Chinese market. However, it would take a couple of quarters to fully transition aligner production from Juarez to Ziyang, and we would expect manufacturing overhead in Ziyang to be underutilized during this period. Product and technology innovation continues to be a key growth driver across our regions. Over the past year, we launched several new Invisalign offerings for both comprehensive and non-comprehensive treatment to give doctors more tools and choices to treat a greater range of cases, from adults to teenagers and now even kids as young as 7 years old. In mid-2018, we launched a new Invisalign Go product with a more user-friendly iTero digital chair-side experience and greater flexibility to treat a wider range of mild to moderate cases such as crowded or gapped teeth that require teeth straightening prior to restorative treatments. We also began offering Invisalign First, designed specifically to address a broad range of younger patients' malocclusions, including shorter clinical crowns, management of erupting dentition and predictable dental arch expansion. We're pleased with the initial uptake and customer feedback. In 2018, we shipped nearly 5,000 Invisalign First cases to over 1,300 doctors, primarily in North America, EMEA, Australia and New Zealand, and Japan. And in October, we received FDA approval for Invisalign with mandibular advancement feature in the U.S., which is the only clear aligner product approved to simultaneously move teeth and the mandible in young patients. In Q4, we began shipping mandibular advancement in the U.S. Late in the quarter, we are seeing initial uptake along with continued ramp globally. To date, over 17,000 teenagers have used Invisalign treatment with mandibular advancement, led by China, Canada, France and Spain. Overall for the teen market, in Q4, over 87,000 teenagers started treatment with Invisalign clear aligners, an increase of 37.3% year-over-year, driven by continued strong adoption across all major regions, driven by both the Americas and EMEA regions. For Q4, year-over-year Invisalign teen patient growth for North America orthos increased 23.7% and international doctors were up 63.7%. For the full year, total teen cases worldwide grew 40.3% to a total of 333,000 teenagers, or 27.1% of our total volume. Our consumer marketing efforts are designed to build the category and drive demand for Invisalign treatment through a doctor's office. We invest over $100 million each year in consumer marketing and programs, including TV, digital, social media, PR, event marketing and more recently, our patient concierge and Invisalign Experience program. Our goals are to make the Invisalign brand a household name worldwide and to motivate consumers to seek Invisalign treatment through a doctor's office. In Q4, we continue to see strong digital engagement with consumers and had nearly 4 million unique visitors on invisalign.com sites for a total of 17 million over the year. Other key metrics show increased activity and engagement with the Invisalign brand and are included in our fourth quarter slides. The impact of the digital technology on our world and specifically in our industry is challenging our customers to evolve just about every aspect of their practice, especially how they engage with consumers and turn them into patients. What worked for doctors in the past from a marketing, conversion or workflow perspective will not work today. Consumers expect more and are demanding different types of digital-driven expenses. Many doctors don't know where and how to start. The work we are doing with our integrated consumer marketing platform, patient concierge service, and Invisalign Experience program has given us better insights and information that we're sharing with doctors to help them reshape their practices. For example, the Invisalign Experience program is designed to reach consumers in a retail environment where they shop, play and dine and educate them on the benefits of Invisalign treatment and value of getting a better smile and connect them with an Invisalign doctor. One of the ways we do this is through the Invisalign store, which is owned and operated by Align. Invisalign stores bring the brand directly to consumers in a contemporary, interactive digital environment. Consumers can browse, ask questions, learn about Invisalign treatment and technology, and the benefits of straightening their teeth. Visitors are offered a complimentary iTero intraoral 3D scan and a visual simulation of what their smile might look like after Invisalign treatment. Interested consumers are connected with a local Invisalign doctor's office of their choice to discuss potential treatment options. By the end of 2018, we finished with 12 locations in the United States, and these stores are helping us learn more than ever about reducing barriers to treatment for potential patients so that they are excited about getting a better smile with an Invisalign doctor. In addition to providing potential leads to participating Invisalign practices, we're also seeing a positive halo effect and increased growth rates for all of the Invisalign practices in the surrounding area, whether they participate in the store network or not. Over the past year, more than 55,000 consumers visited Invisalign store and nearly 10,000 received a complementary scan. While we are still early in the development of our Invisalign stores and the overarching Invisalign Experience program, we're excited about its potential and the positive impact we can have on demand creation for Invisalign practices by engaging directly with consumers. The Invisalign Experience program is just getting started and continues to evolve. In October, we announced that we're partnering with a few Invisalign doctors in selected U.S. cities to pilot new ways to reach consumers and connect them directly with doctors to start Invisalign treatment. These Invisalign Experience locations are owned and operated by doctors under a special license from Align and are intended to help doctors integrate consumer friendly design and consultation workflow into their practices and test new Invisalign Experience branding and explore a consumer focused approach to consultations and Invisalign treatments starts in a variety of settings, including in-office, retail and mobile. We'll continue to share our learnings as we get more of these pilots up and running. Finally, I want to spend a few minutes talking about digital technology and the transformation in our industry from an old analog process to an end-to-end digital workflow. Align is helping doctors on their digital journey, which starts with an iTero scanner and ends with stronger practices and better smiles for their patients. As a leader in digital orthodontics, we are best positioned to help Invisalign-trained doctors find more efficient ways to drive digitalization in their practices and support those practices and to help them improve their productivity over time. To that end, last year, we launched project [PNO] we now call -- we have renamed it ADAPT, Align digital and practice transformation, with several small orthodontic clinics across EMEA, APAC and North America with the objective to demonstrate that a fully digital practice can be productive, efficient and profitable. Process involves detailed analysis of the current practice data and workflows performed by experts and continuous improvement in workflow. While it's still early, the initial results from the ADAPT study are incredibly promising. Based upon the study on practice development, we've come to the conclusion that the benefit fully from technology and to own the digital transformation of their practices, doctors need to organize their workflows and premises so that approximately 80% of their organization is built around this digital transformation with clear aligners. This means that doctors who commit to digital transformation had the potential to do more, see more patients and expand their practice or take more time off. Whatever their goals, with Invisalign plus iTero together, we can help them see the benefits they want from a fully end-to-end digital workflow. For iTero scanner and services business, Q4 was a very strong quarter with better-than-expected revenues, which were up 13% sequentially and 54.8% year-over-year, driven by strength in all regions and customer channels. Record Q4 volumes reflect continued commercialization of the iTero 2 Element and Element Flex scanners, especially for restorative GP dentists in North America, the continued rollout of our major DSO partners and increased sales internationally, including Italy, Japan and China, where we began manufacturing the iTero Element this past year. For 2018, we had an outstanding year for iTero scanners with volumes up 77.2% year-over-year. Cumulatively, over 11.5 million orthodontic scans and 3.2 million restorative scans have started with iTero scanners. Use of the iTero scanners for Invisalign case submission continues to grow and remains a positive catalyst for Invisalign utilization. For Q4, total Invisalign cases submitted with digital scanner in the Americas increased 72.6% from 65.3% in Q4 last year. International scans increased 57.5%, up 41.4% in the same quarter last year. What's really exciting to see is that within the Americas, 88.7% of cases submitted by North American orthos were submitted digitally. In China, it went from 0 to 45.9% in 1 year. This means that within 1 year or 2, nearly all Invisalign cases will be submitted digitally, primarily through an iTero scanner. We're very excited about the continued progress we've made with iTero business overall, and remain confident that will continue to help drive our overall growth and help increase adoption of Invisalign treatment. With that, I'll now turn the call over to John.