Caren Mason
Analyst · Stephens. Your line is open
Thank you, Brian. Good afternoon everyone, and thank you for joining us on today's call. The fourth quarter and fiscal 2020 results we reported today are consistent with our January 11’s preannouncement and represents yet another year of record results, increased consumer awareness, and growing surgical commitment to our proprietary EVO Visian family of Implantable Collamer Lenses. The COVID-19 global pandemic challenged our generally high levels of growth, particularly in the first half of 2020. However, for the second half of 2020, we were able to meet the original sales targets we entered the year with prior to the global pandemic, taking hold in late January. 2020 demonstrated the continuing momentum of the industry shifts towards our lens-based solutions for patients seeking visual freedom. In addition, in 2020, we launched a new presbyopia optic lens, EVO Viva and made progress towards introducing our EVO family of lenses in the U.S. and introduced new programs to increase customer engagements. Our 2020 performance confirms our position as a consistent and rapidly growing innovative leader in the refractive industry. Turning now to the fourth quarter, ICL unit growth in the fourth quarter continued to rebound we saw in the third quarter as more of our markets more fully reopened. We achieved strong growth in several markets including, China up 17%, Japan up 52%, Germany up 28%, APAC distributor markets up 71%, and Latin America, up 26%, all is compared to the prior year quarter. We also saw a significant sequential improvement in India during the fourth quarter where ICL units on a year-over-year basis were down just 10% in the fourth quarter of 2020 as compared to down 55% in the third quarter. The Middle East remained our most challenged market due to COVID-19 during the fourth quarter. For fiscal year 2020, ICL units were up 11% as compared to the prior year. Our positive ICL unit growth must be considered in the context of the global pandemic and also the total market for refractive procedures. Industry reports estimated decline of 21% in total refractive industry procedures in 2020 as compared to the prior year. The CASM between STAAR’s positive ICL unit growth rate and the decline in total refractive industry procedures demonstrates that we are continuing to capture market share. Therefore, while our growth in certain markets remains impacted by COVID-19, our enthusiasm for even brighter days ahead is bolstered by solid second half results in 2020 and a solid start to 2021. Our strategic imperative remains to position our EVO ICL family of implantable lenses as a transformational pathway to visual freedom for patients seeking a life independent of glasses and frequent replacement contact lenses. Our strategy supports the transformation to a lens-based future for refractive vision correction and should allow STAAR to capture a disproportionate share of the 5.8 million annual refractive procedures that industry market reports project in 2025. Today and as we look ahead, we are laying the foundation for a STAAR that can grow from selling hundreds of thousands of lenses per year to millions of lenses per year to increasing consumer awareness, social commitment, new product introductions, and appropriate investments to scale the company consistent with our significant growth opportunity. I will briefly touch on each of these areas to illustrate our focus and commitment. First, we have increasing evidence that our multi-channel consumer awareness and marketing activities globally are showing positive results where we promote the exceptional favorability of our EVO ICL family of lenses to consumers, we see great enthusiasm among consumers on social media, more visits by consumers to our doctor finder and higher ICL unit growth including in China, Japan, Korea and Germany to name a few. EVO Visian ICL patient influencers from television or music personalities to everyday people are creating meaningful interactions with their followers on various social media platforms such as TikTok, Little Red Book and Instagram that resulted these followers becoming prospective patients. Our investment in consumer marketing is supported by marketing research such as 40 point plus upticks in ICL interest in key markets when consumers understand the advantages of our ICL lenses, including removability, no dry eye syndrome and excellent night vision. Marketing research shows a 60 point increase in interest among U.S. consumers. Second, we are gaining increasing surgeon commitment with our lenses, which is supported by clinical validation. 2020 is the first year STAAR sold more lower diopter lenses between minus 0.5 and minus 10 than higher diopter lenses between minus 10 and minus 20. Our opportunity with surgeons includes training and certifying more refractive surgeons globally and also increasing the number of ICL lenses implanted by currently certified surgeons. Increasing lens utilization remains a significant growth opportunity for STAAR as surgeons can move from implanting tens of lenses per year to hundreds or even thousands as we’ve seen in certain Asian markets. Turning to a third strategic priority, which is introducing our innovative products to large and new markets globally. We are continuing the controlled roll out of EVO VIVA presbyopia lens in Europe. The initial commercial surgeons are implanting the VIVA lens are gaining valuable insights for delighting patients at each distance, near, intermediate, and far. These insights will be part of the EVO VIVA playbook of best practices that we will share with certified surgeons during full commercialization of the lens expected in the second half of 2021. In the coming weeks, we will add more surgeons as part of our phased roll out of the VIVA lens. In the U.S., we have implanted all patients in the study for our EVO family of myopia lenses and follow-up is being conducted for the trial protocol. Our plan remains to submit the data to the FDA for marketing approval in late April. We will provide an update on the status of our submission and any other details when appropriate and permitted. The U.S. has the number to market in the world for refractive procedures as long their market where we look forward to introducing our family of EVO lenses. We believe we remain on track pending FDA approval to introduce our EVO lenses to the U.S. market in the fourth quarter of this year. Finally, we continue moving forward with scaling the company to meet increasing demand and position STAAR to sell millions of lenses in the future. Capital investments include the following: establishment of our EVO manufacturing operations in Nidau, Switzerland, and our advanced presbyopia VIVA lens manufacturing facility in Lake Forest, California, Also expanding capacity of our Monrovia manufacturing facility. Operating investments include, scaling our revenue generating sales and marketing teams and programs. We have recently added key hires to the U.S. sales team and we’ll continue to support our growth in China with additional in-country STAAR account executives. We will also invest in marketing programs in geographies that can demonstrate strong returns by driving higher levels of ICL unit growth. Before turning the call over to Patrick, let me conclude my prepared remarks by welcoming two new members to the STAAR Board of Directors, Dr. Elizabeth Yeu and Dr. Peony Yu, who joined the Board as previously announced on January 21. I would also like to thank retiring Board members John Moore for his more than decade of service to STAAR. Patrick?