Caren Mason
Analyst · Canaccord Genuity. Your line is now open
Thank you, Brian, and good afternoon everyone. I'll begin this afternoon with an overview of the continuing momentum in the global market for our ICL product line as well as for solid financial performance generated by our company during the third quarter. Additionally, I'll provide an updated outlook of our full year financial performance. And finally, I'd like to share with you our team's updated research on the total viable patient population for both myopia refractive vision correction and presbyopia vision correction to help illustrate the significant opportunity that lies ahead for STAAR surgical. Deborah will then review key third quarter and year-to-date financial results. The ICL's momentum in the global market established during the first half of 2018 continued through the result and resulted in a 46% increase in ICL sales as compared to the prior year period. Total revenue for the quarter grew 35% over the third quarter of last year. Our gross margin continued to expand primarily due to higher ICL contribution to total sales. The gross margin 75.1% of sales was up 330 basis points over the prior year quarter. ICL sales represented 83% of sales mix while other products accounted for the remaining 17% of sales. During the quarter, we also continue to execute our plan to make targeted investments designed and faster continued future growth. And despite these investments, we earn $0.03 per share on a GAAP basis and $0.07 per share on a Non-GAAP basis. I'd also like to note that we generated $8 million in cash from operations during the quarter, which is a new record for our company. Combined with the proceeds from our very successful placement of slightly less than 2 million shares in early August, STAAR's balance sheet has never been stronger. Cash and cash equivalents as of September 28 exceeded $102 million. Turning to our regional ICL performance as we expected and plan for, the growth was driven by our Asia-Pacific markets. The second and third quarters are the high season for refractive surgery in this region of the world and this year was no exception. In units, China grew 100%, Japan grew 95%, India grew 27%, and the rest of Asia-Pacific grew 38%. Overall, the Asia-Pacific region grew 79$ over prior year's third quarter in units. As I mentioned, China our largest market turned in another exceptional quarter with 100% unit growth. Our strategy of building the market for visual freedom through patient awareness, education, marketing and strategic agreements with our customers, has positioned the ICL as a premium and primary solution for vision correction and this is the largest refractive market in the world. We have been doing internal analysis to determine how our strong growth in China has translated into refractive procedure market share. Our analysis to-date indicates that STAAR is capturing market share from laser vision correction. And in China, our data indicates we have more than tripled our market share from low single digits in 2016 to more than 10% as the end of Q3 of the current quarter. Our goal is to continue to grow in China, expand the overall market for refractive vision correction and replicate this growth in market share achievement in other key markets. A key driver of the accelerating adoption of the ICL is a premium and primary solution for vision correction is the increasing demand down the diopter curve. Just a few quick examples, in China the average ICL diopter implanted in 2016 was 10.92 and the first half of 2018 it was down one diopter to 9.9. In Sweden, the average ICL diopter implanted in 2016 was 8.32 and in the first half of 2018 it was down to 7.84. We believe our enhanced relationship with strategic partners in these countries contributed to these results. This increased demand down the diopter curve as well as pricing based on volume growth at lower diopters is way our unit growth through the quarter is higher than our revenue growth. Let's now turn to the rest of the world. The third quarter has always been our slowest growth period of the year in Europe and the Middle East given holidays schedules and the annual ESCRS conference. Nonetheless, we experienced healthy unit growth in Germany of 20%, Spain at 16% and European distributors 18%. In total, EMEA group 13% year-over-year in units. Based on current trends, we expect the year-over-year fourth quarter growth rate in EMEA will accelerate from the third quarter level. In North America, Canadian ICL units grew 18% though our total revenue for North America declined 8.6 primarily due to decline in other product sales. Overall, ICL revenue from the region was flat, volumes increased 1%. On September 13th, we received the FDA's approval of Toric ICL. I'm pleased to announce that the first patient implants of TICL took place last week and we're ahead of schedule for a stage rollout. Interest among U.S. surgeons is very encouraging and currently we expect North American to grow as we further progress with our rollout. During the quarter, we conducted our Annual Experts Summit and exhibited at ERCRS. Both were in Vienna, Austria and both with the most successful STAAR participation ever at these events. The quality of dialogues among surgeons about the ICL was remarkable and their enthusiasm for the current and future products was probable. During our invitation only experts meeting, our principle investigator from the initial first-in-person clinical trial of EVO lens for presbyopia presented its study data to surgeons. The data was very well received by the audience. We look forward to sharing that more broadly in future when permitted and appropriate. I would now like to update you on our thoughts regarding 2018. We exceeded expectations for all key financial metrics during the third quarter and we expect to meet our expectations for the fourth quarter. We continue to believe that the foreseeable future, our quarterly revenue cadence is likely to be the highest in the second quarter followed by the third. The success of our strategic alliance agreement has established greater global consistency and how STAAR manages the business and clinical partnerships with all ophthalmologists that want to elevate the ICL to the premium primary vision correction solution in their practice. And our announcement about the extension of this model to a single site practice in Munich provides some direction about our approach for the global market. For the full year, we expect that sales growth should exceed 30% based on current market conditions. Furthermore, we believe that for the full year, our ICL unit growth and revenue growth will be approximately equal. From a profitability perspective, as we demonstrated during the third quarter, we are making investments to foster our longer term growth and are also achieving profitability ahead of our internal expectations. Based on the nine months results and our achievement of $0.09 a share on a GAAP basis so far in 2018, we now expect to be profitable for the full year as compared to the $0.05 loss in the 2017. Finally, I'd like to take a few moments to share with you some of the data our team has collected and evaluated during the past several months on both the myopia and presbyopia market opportunities. We believe the viable patient population or total available market for mid-to-high diopter myopia refractive emission correction is now more than 35 million people globally which would represent more than 70 million ICLs. We've arrived at the assessment based on a regularly updated analysis that considers epidemiological data on the distribution of uncorrected refractive error by age, discussions with our refractive surgeon customers and patient ability to pay that suggest approximately 10% of the 350 million people globally that need mid-to-high eye diopter myopia distance vision correction are viable candidates for STAARs ICL family and lenses. We now conservatively estimate that our current available market opportunity in myopia is at least 720,000 lenses annually which would represent STAAR capturing 20% of the current refractive procedure global market which is estimated to be 3.6 million procedures. One eye equals one procedure for the refractive market and our 720,000 lens annual estimate is derived from our internal estimates based on market scope and search and data regarding mid-to-high diopter patients. By no means do we believe this market opportunity at this time for ICL myopic refractive correction is capped at the current estimated opportunity. Our expectation is that as more patients and surgeons understand the significant patient satisfaction associated with ICL, the potential available market should grow considerably towards the millions of procedures I've previously identified as opportunity. Turning to presbyopia and as we have noted for the past 18 months, we believe the market for early presbyopias ages 40 to 45 to 55 is significantly larger than the myopia market. Applying the same analysis that we applied for myopia, namely epidemiological data on the distribution of presbyopia discussions with customers and patient ability to pay that suggests a similar 10% viability factor as myopia would yield a viable patient population of 55 million early presbiops, a 110 million lenses. Our estimated annual presbyopic market of 1.5 million lenses reflects our internal estimates based on among other things market scope, internal and surgeon data regarding patient demographics, ability to pay, proximity to a qualified surgeon and willingness to undergo a refractive procedure. This 1.5 annual lens opportunity is additive to the global refractive procedure count estimates of 3.6 million procedures, creating a potential market increase of 46% to an opportunity of 5.1 million procedures annually. Therefore, when we add myopia and presbyopia current estimated annual market opportunity for ICL lenses, we believe we should target a minimum of 2,220,000 lenses annually in the coming years. And with that, I will now turn the call over to Deborah.