Brian Moore - IR, EVC Group Caren Mason - President and CEO Deborah Andrews - CFO

Jason Mills - Canaccord Genuity Chris Cooley - Stephens Andrew Brackmann - William Blair Bruce Jackson - the Benchmark Company Jim Sidoti - Sidoti & Company

Thank you, Andrew, and good afternoon, everyone. Thank you for joining us on the STAAR Surgical conference call this afternoon to review the Company's financial results for the third quarter, which ended on September 28, 2018.

On the call today are Caren Mason, President and CEO of STAAR Surgical; and Deborah Andrews, Chief Financial Officer. The release of the third 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 risk 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 supplement the GAAP numbers, we have provided non-GAAP adjusted net income and or loss, adjusted earnings per share and net income and or loss per share information.

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 call 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. Now, I'd like to turn the call over to Caren Mason, President and Chief Executive Officer of STAAR Surgical.

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.

Thank you, Caren. Good afternoon everyone.

I'll start the financial overview with a summary of top line results and then provide more details by product and market. STAAR reported net sales of 31.8 million in the third quarter of 2018 an increase of 35%, over the 23.5 million reported in the year ago period.

As Caren mentioned, the strong top line increase was driven by ICL revenue growth of 46%. Other product sales were essentially flat down 0.2% in the third quarter of 2018 and accounted for approximately 17% of our 31.8 million in net sales.

Moving down the income statement, our gross profit margins of third quarter was 75.1% up 330 basis points compared to the prior year period gross margin of 71.8%, and while sales increased 35%, gross margin dollars increased 42%. The improvement in gross margin resulted from lower unit cost, favorable product and country mix, and lower freight and inventory provisions partially offset by the effect of lower average selling prices.

For the 9 month period ended September 28, 2018, net sales grew 41% to $93 million and our gross margin expanded from 73.9% -- to 73.9% from 71.3%. Total operating expenses for the third quarter were $22.3 million essentially flat on a quarter-to-quarter sequential basis and a 41% increase compared to the prior year quarter of $15.8 million.

Adjusting for the calendar shift of the ESCRS Trade Show, total operating expenses would have increased approximately 32% compared to the prior year quarter. Taking a closer look at the components of operating expenses, G&A expense was $6.1 million as compared to $4.7 million during the year ago period.

The increase in G&A spending is due to increased compensation cost including stock based compensation, facility cost, travel and investments in enhanced cybersecurity systems. Marketing and selling expenses were $10.6 million as compared to $6.5 million and included the calendar shift of almost $1.5 million for ESCRS that occurred in the third quarter of this year compared to the fourth quarter of 2017.

The remaining increase in marketing and selling expenses was due to increased investments in digital, consumer and strategic marketing, and commercial infrastructure. On a sequential basis, our third quarter marketing and selling expenses were flat to second quarter as the decrease in other marketing and selling expenses fully offset the increase due to the ECRS.

Our R&D expenses were $5.6 million which were up approximately $1 million from the year ago period due to an increase in EDOF clinical trial expenses, medical affairs which began in Q4, 2017, and increased regulatory expenses. We generated operating income of approximately $1.6 million during the third quarter.

Net income during the third quarter was approximately $1.5 million or $0.03 per diluted share compared to the year ago period of $1.2 million or $0.03 per diluted share. On a Non-GAAP basis, we reported adjusted net income for the third quarter of $3.4 million or $0.07 a share compared with adjusted net income for the same period of 2017 of $1.5 million or $0.04 a share.

A table reconciling the GAAP information to the Non-GAAP information is included in today's financial release. Turning now to our balance sheet.

Our cash, cash equivalents and restricted cash at the September 28, 2018 quarter-end totaled $102.3 million compared to $21.4 million as of June 29, 2018. The Company generated approximately $8.1 million in cash from operating activities in the third quarter of 2018 as we benefitted from the payment of accounts receivable built during the second quarter.

We generated net cash from financing activities during the quarter of approximately $73.6 million, which included proceeds from the sale of slight investment 2 million shares of common stock and approximately 2.2 million in proceeds from restricted stock and stock option exercises. Now operator, we're open for questions.

So I'll try to limit myself to two questions. Caren, you know that's difficult for me, but I'll do my best to follow Brian's rules.

The first question I'll ask and I'll shut up the most likely answer and I'll come back for the second. The first one has to do with whatever you're willing to give us in terms of initial expectations for 2019 or how you see 2019 date in terms of your ICR business?

And as a sort of a Part B to that, how you see the United States market playing into your growth profile for the next 12 months? And clearly where I'm going with that Caren, is any discussions or thoughts you can share with respect to the EVO family of lenses and the potential launch in the United States markets?

Okay, very good. So as you can imagine, we're deep into planning for 2019 and we're continuing to benefit from the momentum that we have experienced in the past quarters and look forward to enhancing in the coming quarters.

With regard to what those numbers would look like in January we'll be talking about that at the JP Morgan Conference. But in terms of outlook, momentum, confidence, we're feeling exceptionally bullish about 2019.

In terms of the U.S. market, we expect the U.S.

market as I said in the press release to positively really reenter the positive column for our business in terms of sales, units and profit. We know that's the Toric ICL based on the fact that, we actually had early implants starting on October 22nd in major cities such as Los Angeles, San Antonio, St.

Louis and Phoenix. We have excellent reports from doctors and patients and a lot of media coverage both television and newspaper with enthusiasm.

Just quick Halloween story. One of our first patients was implanted a young mother with three children who was so thrilled about her vision correction that when they carved pumpkins for Halloween, their pumpkins were made with ICL images on the pumpkins.

So and we shared those yesterday with our corporate Halloween party and it was quite fun. I think the bottom line here is that we can expect the United States to have a strong but orderly rollout to make absolutely sure that our surgeons are certified and their staffs are ready and that patient communication materials and practice development is outstanding.

We're talking about 15 major markets over the next several months. And in talking to a number of surgeons at AAO, they're very excited and they have waiting lists of patients.

So its impact on this year will be moderate, but its impact next year is why we will be in the plus column. With regard to EVO, we're very excited about what we are putting together in terms of a package for submission that we believe is very, very compelling.

We have surgeon input. We have lot of data.

And when the time is right and I'm able to, I will be excited to share that submission information.

Second question around presbyopia and thank you for all the targeted market data, I get that question a lot and that was so much clear than I could have put it personally. It's clearly a big market and I think a lot of folks go for reasons of potentially investing in the stock and as a potential customer are interested in that product and that data.

I know I am struggling with the reading vision as we speak at the lower end of that age range you talked about. And so, my question is, can you update us in terms of how you see that product progressing through the regulatory channels in Europe and the United States and whether anything is changed there?

And what specific metrics those trials are looking at? What you think you need to see from a clinical data standpoint or clinician need to see for that product to realize the potential that you very well outlined in European analysis?

And I'll get back in queue. Thanks, Caren.

So my Vice President of Clinical and Medical Affairs and my Head of Regulatory are listening in. So you can only imagine what they're feeling right now.

Because obviously, I have great answers to your questions, but there is so much I can share at this point since we have an active pivotal clinical trial. So here is what I can share.

Bottom line is that the EDOF element associated with visual optic, the presbyopic lens whether it'd be in a cataract form or where that's the only company we believe that will have phakic IOL for presbyopia. We would exceed the expectations that you would imagine are being promised or delivered or detailed today by surgeons for cataract lens with an EDOF optic.

Our goal is to exceed that in terms of targeting refractive correction and patient satisfaction. In terms of where want to sell pesbeyopic lens is everywhere.

We're starting certainly in the CE Mark countries in Europe where we will initially submit our data from the study. We are also talking to our partners in Asia-Pacific in China.

And we certainly are talking about the EVO family of lenses as we approach CDRH in the U.S. So all-in-all, we feel very confident and excited about the presbyopic product and what it can mean.

I'll keep it to two as well. Could you -- you gave some great detail in terms of kind of the changing mix as you go low in terms of the diopter curve and what that means to potential growth.

So if I can maybe take a page from Jason's playbook for my first question. Could you just talk to us a little bit about how that change in mix overtime plays through the P&L both from a margin but also from a growth -- I should say from a growth and then also from a margin perspective?

And then, is that maybe as an offshoot of that question, is that, what's really driving that step up in the moderate -- mid-to-moderate myopia estimate when I think about that versus your prior number which I believe was 500,000 you had a 120,000 high myopes? So is that really what's driving the step up in your end market?

Than I have a follow-up.

Yes, where we are in terms of lower diopters which would qualify as mid is that, as we began to expand the total market share and growth requirements of our larger strategic partners, where they have already had such success with expanding dramatically their use of the lands, we work on making sure that we can provide an appropriate volume to price ratio for improvement and increased volume with the use of going down diopter curve. So the best way to look at it is, if in fact we want to grow much faster there 30% or 40% or even higher, then it we make absolutely sure that price elasticity makes sense at the lower diopter range as compared to volume.

So, our expectation is over time, you're going to see a much higher volume trajectory, you're going to see a leveling of price points of the lower diopter levels, and the retention of premium pricing for all Toric and high diopter level lenses. The manufacturing costs et cetera continue to get us in the mid 80s range for gross margin and we see that not changing other than upwards or improving.

So, it's all about volume, Chris, and everything else falls afterwards, but we're managing it I think quite well with our partners. And so where you saw the higher volume as compared to sales and ICLs in Q3, it was really related to the fact that those were very high volume, more down the mid diopter range purchases in that particular quarter.

That's most helpful and if I could my second question. China and the Asia-Pacific region have just been phenomenal stand else for the Company and I look back here through the year, you had 91% growth I believe in units in China in the first quarter a 127 in the second and now you know 81% unit growth, and if I'm doing the math right about over 40% of revenue.

Could you talk to us about your confidence in the sustainability of growth in China where you know a little bit north of 10% market share? And what if any implications we should think about from both an economic and also maybe from a tariff perspective you know, is this sustainable?

And does the new model insulate you somehow here? Or just help us think about that a little bit more?

Thank you so much.

Sure. And that's a great question and I have a great answer.

So, bottom line is that, our partnerships in China have never been stronger. We've just met with all of our key larger accounts including our largest account Aier.

We have agreed to a very strong 2019 and beyond. We are very aware in sharing appropriately about how we manage tariffs, how we manage growth, and what a trajectory is for market in terms of total percentage and share of all procedures for all of our biggest partners.

And I can tell you that everyone is signing up very aggressively for '19 and beyond. So, we're feeling very good about China.

This is actually Andrew on for Brian. I wanted to first start with the question on guidance exceeding 30% for the year.

And I think your comment was that the ICL growth should be in that same ballpark that implies a pretty substantial step down in the fourth quarter. So maybe time that into your commentary on the second and third quarter strong.

And maybe a little bit more on the visibility into why you're calling to that guidance in the fourth quarter?

Okay. So, the 30% was total, not ICL.

So, it was we are going to increase our top line in excess of 30% for the year. We did not call out ICL growth, but certainly it would be near to the range that we have been reporting over the last quarters in terms of the growth for the ICL.

There is no relaxation there. There is no decrease.

The increase from 25% to in excess of 30% again Andrew is the top line.

So then maybe going back to your comment on the second and third quarter being the strongest and can you maybe just provide a little bit more detail on why that is you caught out the busy seasons in the press release? So I'm just trying to tie into next couple of quarters.

Sure. So we have in 2017 had sequential growth every quarter.

And then when the age specific region became more and more of our total volume and the busy season was in the second quarter in terms of making sure, we order enough in preparation to start in June and then in the third quarter to actually deliver and build for procedures. Q2 is now our largest quarter we believe going forward, Q3 second largest followed by Q4 and Q1.

And so, that's the way we see it; however, we expect that Q4 will still be a strong fourth quarter in growth over prior year. So when you look at the year as a whole, we're seeing in excess of 30% and as you know we like to be prudent.

If we could talk about the Toric ICL launch in the U.S., if you could give us a few more details on your launch plans, and how you anticipate that the sales are going to are grow over the course of 2019?

Well, we certainly see double digit growth in the 2019 in the U.S. and a lot of that being the mix of lenses especially for the Toric growth.

We have talked to doctors who have set to us that they want to in some cases wait to implement Toric because they believe that some of their patients are borderline et cetera. But I think, we expect that the MICL will also pick up as we begin to show what we can do with the Toric.

And that a number of these practices haven't been aggressively using our lenses for a while, they kind of used us under the old not premium and primary but more about if you don't qualify for LASIK as a rationale. So now by introducing the Toric, we are re introducing the ICL in its entirety in terms of the business model, the clinical model, the patient, advertising and that's why in the markets where we went first with some of our highest implanting ICL surgeon partners, there was a lot of media coverage, a lot of patient in terms of waiting lists.

And so, we expect that the Toric will rejuvenate and it's a wonderful reentry into the U.S. market.

And the next question that we always get is. When can I have EVO?

EVO is a game changer we see it as a skyrocketing moment and potentially we've been told by some surgeons that they expect to flip their mix from 80%, 90% laser to 20% to 10% percent ICL to the opposite with ICLs becoming 70% or 80% of their total volume. So, we believe the combination of getting Toric, reenergizing the U.S.

market with the ICL then following on with EVO, will get us some very, very strong numbers and we'll manage it like we've managed China.

And then, India, the press release you've talked about the enthusiastic receptions from the surgeons at [Oscars] when they were looking at the EDOF data. Can you, without going into the actual data details, can you maybe comment on some of the aspects of the product performance or the use of use that made the surgeons so enthusiastic?

Well, certainly, we covered the performance of the lens in terms of best corrected visual acuity. We talked about patient satisfaction and there was very excellent and positive response from the attending surgeons.

That's the most that I can give you until we get permission from our regulatory authority that we have approval on the pivotal trial and then all the data will be released.

So, Caren, you guys really waited in Asia to get EVO approved before you put on the gas with the strategic cooperation agreements and the marketing programs. Do you think you'll be a little quicker here in the U.S.

with the Toric? Or do you anticipate waiting for the next generation here in the U.S.

before you really pushed the lens?

Well, just to clarify. When I joined the Company as CEO in March of '15, there was a different positioning of the ICL.

With Aier Hospital Group and in China as well as in Scandinavia, we began to rebuild of business at clinical models as well as the positioning. And so, EVO was reintroduced in China with all of this new strategic cooperation, agreement, mechanics associated with building a market and assisting our partners in moving from laser vision correction where it makes sense to ICL.

In the U.S., we have a different in some ways. We are reintroducing the Company the ICL in to a number of surgeons as well as expanding and reenergizing other surgeons.

But my expectation is that with EVO because of the extraordinary performance of the lens and because of the elimination of peripheral iridotomy presurgical requirement, we're going to end up in the U.S. having a quicker adoption, and we believe faster growth because the work we're going to do with the Toric over the next several months to a year.

Okay. So I guess what you say is, you're going to aggressively promote the Toric and then you think when you do get EVO approved, it will be even easier to make that transition here in the U.S.

because the Toric awarded and accepted a lot of physicians. Is that what you say?

Yes, very good, Jim.

Okay.

You said it better than I did.

And then, as you look at the balance sheet, I think Toric up couple of million this quarter from last quarter. Is that in anticipation of the Toric launch?

Or is that in anticipation of sales outside the U.S.?

No, no. I mean it's of course we are building Toric ICLs for the U.S.

market. So that's part of it.

but we've really have to significantly increase our inventory levels based on the current level of sales that we've been seeing and now forecasted growth for the future.

And is there any opportunity for your customers to stock or are most of the ones as you shift implanted within a few weeks?

The later, almost all of our lenses are made and shipped to order.

So there is no channel to fill basically. These are all ones who got implanted and need more than a few weeks of shipments?

The majority, most of our distributors pass their order to us when they get the order. However, in some markets where there is very high volume and there is a real strong interest in lessening the lead time on Toric for example, we do have inventory but was managed very carefully.

And the majority of the time we have a maximum of 30 days inventory in any one location.

Thank you everyone for your participation on our call today. We'll be on the road again meeting with our financial community in the coming weeks including at the Stephens Conference on November 7th in New York and the Benchmark Conference on November 29th in Chicago.

We appreciate your interest and investment in our company. All the best to all of you.

Thank you.