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Earnings call · FY2020 Q1
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Thank you, Jesse, and good afternoon, everyone. Thank you for joining us on the STAAR Surgical conference call this afternoon to discuss the company's financial results for the first quarter ended April 3, 2020. On the call today are Caren Mason, President and Chief Executive Officer; and Deborah Andrews, Chief Financial Officer. The press release of our first quarter results was issued just after 4:00 p.m. Eastern Time and is now available on STAAR's website at www.staar.com. Before we begin, let me quickly remind you that during the course of this conference call the company will make forward-looking statements. We caution you that any statement that is not a statement of historical fact is a forward-looking statement. This includes remarks about the company's projections, expectations, plans, beliefs, and prospects. These statements are based on judgment and analysis as of the date of this conference call and are subject to numerous important risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties associated with the forward-looking statements made in this conference call and webcast are described in the safe harbor statement in today's press release as well as STAAR's public periodic filings with the SEC. Except as required by law, STAAR assumes no obligation to update these forward-looking statements to reflect future events or actual outcomes and does not intend to do so. In addition to supplementing the GAAP numbers, we have provided non-GAAP adjusted net income and adjusted earnings per share and sales in constant currency. We believe that these non-GAAP numbers provide meaningful supplemental information and are helpful in assessing our historical and future performance. A table reconciling the GAAP information to the non-GAAP information is included in today's press release. Following our prepared remarks, we will open the line to questions from publishing analysts. We ask analysts to limit themselves to two initial questions, then re-queue with any follow-ups. We thank everyone in advance for their cooperation with this process. And with that, I would now like to turn the call over to Caren Mason, President and CEO of STAAR.
Thank you, Brian. Good afternoon, everyone, and thank you for joining us on today's call. Let me start by saying that the health and safety of everyone around the globe remains paramount and we continue practicing the directives from national and local governments and public health officials. We have been fortunate at STAAR that our global employee team has fared well through this most difficult of times. We continue to wish the best for all of our surgeon partners, their staffs and patients, frontline health care workers, shareholders and analysts and their teams. The first quarter results we reported today illustrate the advantages of STAAR's positioning as a global company with business in over 75 countries. STAAR achieved admirable growth despite COVID-19 headwinds causing a pause in elective procedures across different markets and at various durations. Global ICL unit growth in the first quarter of 2020 was up 9% compared to the prior year quarter. With European distributor business usually more heavily weighted to the third month of the quarter, China not performing ICL implants for 7 weeks of the quarter, and the rest of our markets mostly shutdown for the last 2 or 3 weeks of the quarter, the terrific start in January and the momentum in Asia late in the quarter really proved to be significant. Consistent with the business update we provided on April 13, ICL units grew strongly in key Asian geographies. First quarter year-over-year ICL unit growth was as follows: Japan unit is up 79%, Korea unit is up 14%, China unit is up 7%, and the rest of Asia-Pacific excluding Japan, Korea and China up 37%. STAAR also achieved solid unit growth in markets outside of Asia. In Canada, ICL unit growth was up 10% in the first quarter and in Germany ICL unit growth was up 5% even with the discontinuation of procedures commencing in the second week of March. I am pleased to report that we resumed production last Monday, April 27, at our Monrovia and Aliso Viejo, California manufacturing facilities. We have implemented wide-ranging COVID-19 safety enhancements and protocols at both facilities. With respect to our U.S. EVO clinical trial, our contract research organization is providing clinical study support to the EVO principal investigators, including the restart of patient enrollment following a pause associated with recommendations from states and medical societies with respect to elective procedures and clinical trials. Several of our principal investigator sites have already reopened and resumed patient recruiting, screening, and implantation. At this time, all of our principal investigator sites plan to reopen by May 15. Our EVO EDOF lens for presbyopia remains under review by DEKRA, our notified body. The pandemic may cause a delay in DEKRA's response to our submission. Still, we remain optimistic our EDOF lens will be approved and introduced in a staged rollout to CE Mark countries either in the second or third quarter of this year. Designed for early presbyopia, ages 45 to 55, our EVO EDOF lens targets millions of eyes of opportunity for STAAR for those who want to dispense with their reading glasses. I am pleased to announce that Anvisa, Brazil's health regulatory agency, renewed the approval of STAAR's EVO lenses for promotion recently after a protracted review cycle. Brazil is a country with an affinity for aesthetic procedures and the largest refractive surgery market in Latin America. We are excited to resume sales in this market during the second quarter of 2020 subject to the potential impact of COVID-19 on surgeons or patients. Governments and public health officials globally are beginning to lift stay-at-home, work, and other restrictions in many hotspot geographies. For example, ophthalmic surgeons in China, the largest refractive procedure market in the world, are once again performing EVO ICL procedures across the country. Preparation for the upcoming peak implant season is well underway with planned advertising and patient marketing events. As our key customers begin to resume work around the world, there is significant interest in growing their ICL and EVO lens business, as we have been reporting since November of last year. The move to lens-based surgery continues. During numerous and well-attended virtual webinars and education events sponsored by STAAR and select societies around the globe, the question-and-answer sessions would routinely go an hour or longer than scheduled regarding ICL patient profiling, surgical technique, and practice development recommendations. The reasons most often cited by our customers as we surveyed them for their interest include an emerging EVO patient profile that is younger and perhaps less concerned about COVID-19 than an older demographic as well as a higher profit per eye with an EVO procedure than many other refractive procedures. The COVID-19 pandemic is highlighting the utility of our EVO family of lenses, not only for surgeons but for their patients as well. Patients' stories of lost disposable contact lenses, fears of running out of contact lenses, glasses that fog up while wearing a mask, and concerns about not touching one's face or eyes have been more prevalent on social media in recent months. Frontline health care workers are perhaps experiencing these challenges most acutely. Recently, a U.S. surgeon posted the following note online regarding a frontline worker requesting ICLs: 'After 5 weeks out of the OR, it feels so great to be back. Taking care of one of our own today, a nurse who treats patients at the hospital and feels unsafe touching her eyes to manipulate her contact lenses right now.' In closing, I'd like to comment on how we see the months ahead. As previously noted in discussions with our surgeon partners, it is clear that there is a strong desire to resume refractive surgery quickly once elective procedures are allowed by local government and public health authorities. However, we expect that Q2 will be negatively impacted by the markets that are just returning to reopen their clinics and practices in late May into June. We started 2020 off with the highest ICL sales and unit growth experienced in the last 5 years in a January timeframe. In every open market, that trend continued into the middle of March. The large Asian markets are growing well now. Unless there is another forced closure or a challenging COVID-19 scenario for surgeons and patients beyond Q2, we fully expect to resume the double-digit growth outlook originally targeted for Q3 and Q4. Those are my prepared remarks. I'll now turn the call over to Deborah to further review our first quarter financial results.
Thank you, Caren, and good afternoon, everyone. I'll begin with a financial review, summarizing our top line results before going into more detail on the income statement. STAAR reported net sales of $35.2 million for the first quarter of 2020, reflecting an 8% increase over the $32.6 million from the same period last year. This growth was driven by a $1.6 million or 6% increase in ICL sales and a $1 million rise in other product sales, mainly injectors and injector parts. ICL sales accounted for 83% of total company sales in the first quarter of 2020. Looking at the income statement, our gross profit margin for the first quarter was 70.4%, compared to 74.2% in the same quarter last year. The decrease in gross margin by approximately 160 basis points was mainly due to a higher proportion of lower-margin other product sales compared to ICLs. The remaining 220 basis point change was primarily attributed to period costs linked to the expansion of manufacturing capacity. In the upcoming second quarter, we anticipate recording $1.4 million in manufacturing charges due to a six-week pause in production at our California facilities, which would usually be classified as capitalized inventory. Total operating expenses for the first quarter were $25.9 million, up 15% from $22.6 million in the same quarter last year. The company started to moderate nonessential variable spending in February. Delving into the components of operating expenses, general and administrative expenses in the first quarter were $8 million, compared to $6.8 million in the prior year quarter. This increase was due to a rise in headcount and salary-related expenses, higher tax consulting costs, and greater facility costs. Marketing and selling expenses rose to $11 million from $10.1 million the previous year, driven by increased advertising and promotional activities, along with higher headcount and salary-related costs, although partially offset by reduced travel expenses. Research and development expenses were $6.9 million compared to $5.6 million last year, with the increase due to higher clinical expenses related to our EVO clinical trial in the U.S., increased quality validation expenses, and greater headcount and salary-related costs. Given the optimism surrounding the future of refractive surgery, we have not reduced our workforce and continue to invest for the future, managing variable spending judiciously. During this quarter, we also released $1.4 million from our valuation allowance against deferred tax assets, driven by a change in forecasted foreign income, which allowed a greater portion of NOL to offset domestic income in profitable years, increasing the benefit of the NOLs and the VA release. The operating loss for the first quarter of 2020 was approximately $1.1 million compared to an operating profit of $1.6 million in the same quarter last year. The net loss for the first quarter was $0.1 million, approximately breakeven on a diluted per share basis, in contrast to a net income of $1.4 million or $0.03 per diluted share during the same period last year. On a non-GAAP basis, adjusted net income for the first quarter was $1.9 million or $0.04 per diluted share compared to $4.3 million or $0.09 per diluted share in the previous year quarter. A table reconciling GAAP to non-GAAP information is included in today’s financial release. Now, turning to our balance sheet, our cash and cash equivalents as of April 3, 2020 totaled $110.9 million. The company used $8.2 million in cash for operations mainly due to an increase in accounts receivable and payment of bonuses, both of which are typical for the first quarter. In Q1 2020, we also saw an additional increase in AR related to COVID-19 delayed payments. Based on discussions with our largest customers, we expect to end Q2 with more cash than in Q1. Fortunately, our past-due receivables were at an all-time low at the beginning of the quarter, and we anticipate collections to pick up as elective surgeries are scheduled and customers resume their practices. The company invested $2.2 million in property and equipment during the quarter. These cash uses were partially offset by $1.3 million from financing activities, mainly from stock option exercises. As a reminder, the company generally generates most of its cash in the second half of the year and anticipates a year-over-year increase in cash. We believe our cash reserves and operating cash flows, alongside expected cost containment measures, will provide adequate liquidity for the next 12 months and beyond. This concludes our prepared remarks. Operator, we are now ready to take questions.
Your first question comes from Cecilia Furlong with Canaccord Genuity.
I wanted to ask just about what you're seeing today in China after coming back just in terms of relative standard capacity given enhanced sanitation practices, kind of how you've seen that trend as it slowly started to ramp volume and where that goes going forward relative to pre-COVID level?
Regarding China, when China first started to reopen, there were what I would call extraordinary safety measures that would limit substantially the normal pace of patient procedures, in that there was an hour or two hours between patients for very strong application of sterile procedures to be sure that there would be no possible transmission of the virus. As time went on through April, there was more confidence in being able to increase capacity and still maintain exceptional safety and security for patients. So what we're seeing is a ramping up in China at an aggressive level in terms of the number of patients who are in waiting rooms, which we happily receive videos of from our China team in terms of the amount of special promotions that the largest clinics, hospitals, and practices are putting into effect. In fact, during the recent timeframe of May 1 through May 5, there is an Asia Golden Week and there are special holidays, and a number of retailers were providing promotions and young people in our major markets like China and Korea and Japan were very much excited about and scheduling their ICL surgeries. So I believe that in our large Asian markets, China, of course, at the lead, we're seeing some really exciting fundamentals back in place, we're seeing productivity, and we're seeing the right concern obviously about patient safety.
Great. Thank you for all the color. And then I guess just turning to the U.S. trial. I recognize some centers are just starting to enroll again. Can you talk about just how centers were able to engage with patients in the interim, maybe build patient funnels, and those centers that haven't yet opened, what their positioning will be when they do open to really start and ramp procedures back up?
Our contract research organization has stayed in constant communication with each of our clinical trial sites. Each site is at a different stage in the process, including screening patients, evaluating screening results, scheduling patients, performing implantations, and conducting follow-ups, all in line with our FDA study protocol. Even when clinics were closed, we ensured that all aspects of the clinical trial adhered strictly to the protocol requirements. As a result, we are now resuming operations from where we left off. Depending on each individual's status in the queue for implant procedures or patient qualifications, all necessary work has continued smoothly and correctly. We are excited that by the middle of the month, we expect all sites to be fully operational and opened.
Your next question comes from Chris Cooley with Stephens.
Congratulations on your results during a challenging time. I'd like to follow up on the last question regarding the EVO trial in the U.S. Many of us have noticed a delay in the timing. Could you elaborate on your current progress in total enrollment? Do you think this will set you back by a quarter or maybe a couple of quarters? I'm trying to understand the timeline for completion compared to your original expectations for the EVO trial. I have a follow-up after this.
We have not changed the dates on our clinical trial protocol, which we just updated on clinicaltrial.gov. We are continuing to follow our original completion timeframes. If we need to make adjustments based on developments over the next two to three months, we will do so. However, at this point in time, we have made no adjustments to our clinical trial protocol commitments.
I appreciate your understanding. Lastly, could you provide an overview of the differences you observed across various countries in the Asia-Pacific region, and to a lesser extent in Europe, during the last quarter? Specifically, I'd like to know where you ended the quarter in terms of run-rate. This information would help establish a clearer baseline expectation regarding the decline we might expect in calendar Q2 before you return to the double-digit growth mentioned in your press release and prepared remarks.
Sure. So we made sure that we got information on every one of the markets we serve both direct, hybrid, and also, of course, full distributor coverage from our country managers and our team and our executive team several times a week. And most of the time, we would have a little different point of view than what you might have been reading in local media or national or global media. When we look at Europe, definitely Spain, Italy were impacted greatly and those markets shut down permanently. However, even in the worst of times, some of the best training, education, and virtual connection was happening with our Spanish and Italian surgeons, as well as in other parts of France, for example, the Netherlands, et cetera, Belgium. When we look at Germany, Germany had some clinics that remained open most of the time that others were shut down in other parts of Europe. Germany still, of course, practiced the appropriate guidelines and work at home. But we found that in Germany, which probably contributed obviously to their growth, surgeons were continuing to provide patients with ICLs. We've had some interesting stories. I'm going to share very quickly two of them. One is that one of our European patients has actually had her ICL experience tattooed on her arm from top to bottom and was unable to have them completed because the tattoo parlor was shut down. But she was so taken with the life change that during the COVID shutdown she was on social media showing her tattoo in progress and how everybody should get ICLs because her life had so dramatically changed. We also had a German bachelorette from a bachelor show who also was covered during the shutdown for her ICL enthusiasm in multiple magazines and trade publications. So in Europe, we really had the gamut between what we would call closed, emerging, and open, and those are the three categories that we would check multiple times a week to determine what we needed to do and when. We also kept a running tab of all of our webinars, et cetera. And then we also created a library of educational excellence that we shared around the globe. When you look at Asia, Korea really never slowed down. Korea continued to do the right thing, but the surgeons managed to be open through their challenge. Same with Japan. Even in the height recently of shutdown, Japan continues to aggressively help patients who really want to be visual free with visual safety. And then also obviously China, we were shut down from the end of January through the end of March, a little bit into March, and then we really saw the pickup in the last few weeks in April.
Your next question comes from Ryan Zimmer with BTIG.
Caren, regarding your comments about the double-digit outlook remaining intact for Q3 and Q4, could you clarify whether this aligns with your original guidance of 16% to 20% for the year, or if it simply refers to double-digit growth in general? I would appreciate more detail on that. Additionally, in the last quarter, we observed a significant increase in pricing driven by Toric uptake in the U.S. This quarter, however, the implied pricing seems to be lower. Can you share your expectations for pricing for the remainder of the year?
Sure, Ryan. Regarding the double-digit growth we aim to achieve in the third and fourth quarters, this will depend on the current conditions in the markets we operate in concerning COVID-19 and public health guidelines. If we experience a more normal operating environment where our practices and elective surgeries are permitted, our expectation is that we can achieve growth of over 20% relative to units, particularly in our strongest growth markets. We believe we can exceed that if possible. However, it remains challenging to provide a definitive outlook at this time. What I can share is that in markets where operations are fully functional, we are currently observing double-digit growth. With regards to pricing. Yes. So it really depends on mix when you're looking at our ASPs, how many Torics are out there, as well as what we're doing in the Spheric world. And at this point, we do not believe there's going to be pressure on our ASPs. I think we're going to end up having that become quite positive for us. We will be advancing some support for surgeons around the world in special promotions that we think are going to really advantage in two ways. One is we want to give surgeons tools to bring back their patients as soon as possible. And second of all, we want to help where we can help to encourage for periods of time during opening, maybe a month or two, that we provide lenses here and there to help. So I think overall it's got to be a great combination of supporting the surgeons, pricing to the market, and also managing to get higher demand faster.
Your next question comes from Jim Sidoti with Sidoti & Co.
Deborah, can you just repeat the comments you made about the charge you're going to take in the second quarter? I missed that.
Yes. Well, because the facility, the plant was shut down for a month, basically your six weeks, because we didn't manufacture any product and of course we didn't lay off any employees, the operating expense, the manufacturing expense for that six-week period will have to be recorded as a charge on the P&L and that equates to about $1.4 million.
Okay. And will that go into gross margin?
Yes.
Okay. All right. And obviously your accounts receivable is up in the quarter. Do you think this brought you some goodwill with those accounts and it's something you can leverage later on in the year?
Our customers have expressed appreciation for our understanding during this challenging time. We have maintained very close communication with them, and they have been responsive. They are answering our calls, and we've had numerous interactions, including sales training meetings, to stay connected. I actually received a helpful email today summarizing our international situation, and it appears we'll begin to get back on track in the second quarter, with hopes of returning to normal in the third quarter.
Okay. And the increase in PP&E in the quarter, which plant was that?
A little bit of everything. We made a number of manufacturing improvements in Monrovia, Lake Forest, and in our Swiss facility in Nidau.
So if you do have a big pickup in Q3 and 4, you think you have capacity for that?
Absolutely, absolutely. What we did is we made the decision to discontinue production out of an abundance of caution for our employees when the fear was at its highest and concern was at its greatest. And over time, on a weekly basis, we communicated with all of those employees, told them all the policies that we were looking at, all the protocol changes, all the safety enhancements that we would have. So when our employees came back, I can tell you it wasn't a long path to productivity. It was immediate productivity. And we know we will have the inventory necessary for demand as we see it going forward beyond double digits. So we're in good shape.
Seeing there are no further questions, I turn the call back to Caren Mason for any closing remarks.
Thanks, everyone, for your participation on our call today. We look forward to speaking with many of you in the days and weeks ahead. We will be participating in virtual investor conferences. I'm excited to speak more with you then. We always appreciate your interest and investment in STAAR. Please take good care. All the best to all of you.
This concludes today's conference call. You may now disconnect.