Glaukos Corporation (GKOS) Q4 2018 Earnings Report, Transcript and Summary

Welcome to Glaukos Corporation Fourth Quarter and Full Year 2018 Financial Results Conference Call. A copy of the Company’s press release issued after the market closed today is available at www.glaukos.com. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. [Operator Instructions]. As a reminder, this call is being recorded, and an archived replay will be available on the Investor Relations section at www.glaukos.com. I will now turn the call over to Chris Lewis, Director of Investor relations, and Corporate Strategy and Development. Please go ahead.

Thank you, and good afternoon. Joining me today are Glaukos President and CEO, Tom Burns; CFO, Joe Gilliam; and COO, Chris Calcaterra. Following our prepared remarks, we’ll open the call to questions. To ensure ample time and opportunity to address everyone’s questions, we request that you limit yourself to one question and one follow-up. If you still have additional questions, you may get back into the queue. Please note that all statements other than statements of historical facts made on this call that address activities, events or developments we expect, believe or anticipate will or may occur in the future are forward-looking statements. These include statements about our plans, objectives, strategies and prospects regarding, among other things, our sales, our products, our pipeline technologies, our U.S. and international commercialization efforts, the efficacy of our current and future products, and our competitive market position, financial condition and results of operations. These statements are based on current expectations about future events affecting us, and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements. Review today’s press release and our recent SEC filings for more information about these risk factors. You could find these documents in the Investors section of our website at www.glaukos.com. With that, I will turn the call over to our President and CEO, Tom Burns.

Thanks, Chris. Good afternoon and thank you for joining us today. Glaukos finished the year strong capping an excellent 2018 that saw exceed our financial outlook each quarter bolster our U.S. leadership with the iStent inject launch, drive increased international penetration and make significant clinical and regulatory progress to advance our transformative pipeline. While we’re pleased with the strong performance in 2018 and focused on 2019 execution, we continue to believe we’re still on the early stages of unlocking the Company’s long-term value potential. Today, Glaukos reported fourth quarter net sales of $54.1 million, up 30% versus the year ago quarter and 23% sequentially. For the full year 2018 net sales rose 14% to $181.3 million from a $159.3 million in 2017. We are also issuing 2019 net sales guidance of $220 million to $230 million. Joe will discuss our financial results and outlook in more detail later in the call. Our mission at Glaukos has been aspirational from the outset, the truly transformed glaucoma therapy for the much-needed benefit of patients worldwide. And today we remain ambitious as we seek to transform Glaukos into a global ophthalmic Pharma and device leader by pioneering powerful platforms and sustained pharmaceutical systems, micro-scale surgical devices and diagnostics capable of providing drop-less approaches for effectively managing glaucoma and possibly other ocular diseases. These platforms combined to create a robust portfolio of micro-scale injectable therapies potentially capable of providing an optimized treatment solution at each stage of glaucoma disease stage severity. From the earliest manifestations to the most severe and in both combo-cataract and standalone procedures, they are also providing increasingly promising early-stage development efforts in other ocular diseases. We believe these pipeline platforms if approved could significantly expand our market opportunity at a solid cadence and ideally positioned Glaukos for growth and leadership well into the next decade. To put this in context, using our treatment algorithms and combination therapy expectations, we estimate our U.S. addressable market opportunity could potentially expand sevenfold from roughly 600,000 procedures today to a pull over 11 million diagnosed and treated eyes of which we believe over 4 million can be treated annually. In 2018, we made significant progress to advance our mission with the following key accomplishments. Number one, we’ve received FDA approval and commence the U.S. commercial launch of iStent inject months ahead of our original timing expectations. Number two; we began patient enrollment of key U.S. pivotal clinical studies for iDoseTravoprost and iStent infinite. Three, we continue to deliver strong international growth. Four, we expanded our pharmaceutical capabilities through continued investment and a new pharmaceutical development agreement with D. Western Therapeutic Institute. Five, we added to our patent portfolio of over 200 method and apparatus patents designed to protect the viable technologies that we’ve created. And six, we grew our body of clinical evidence which now includes 104 separate peer-reviewed articles. Our key driver of our success in the fourth quarter was attacked for U.S. commercial launch of the iStent inject, our next-generation Trabecular Micro-Bypass device. We continue to deliver on our expectations since the September launch. Now in full swing, our methodical launch strategy is designed to achieve optimal procedural proficiency and patient safety through supra-relative sales rep trainee and skills transfer to the surgeon. Our seasoned U.S. commercial team is meeting its internal conversion targets with more than half of our installed base either fully trained or in the training process by the end of 2018. We’ve also seen early indications that the iStent inject has the potential to be a market expanding product in the U.S. over time, similar to international experience. Thus far we have opportunistically trained numerous first-time MIGS surgeons on iStent inject despite our primary focus on existing customer conversions. Over the first half of 2019 we’ll remain primarily focused on converting existing iStent planners with a gradual shift of our reps back to training new surgeons who have yet to adopt MIGS along with increasing utilization within existing accounts. Overall, we're very pleased with initial response of iStent inject by the ophthalmic community, surgeon feedback and emerging worldwide results here near our experience in international markets and continue to provide us with high confidence in the product prospects and what it means for Glaukos going forward. U.S. surgeons consistently highlight the elegant and straightforward nature of the iStent inject implant procedure providing them with confidence and predictability of stent placement. They note greater than expected IOP reductions with promising initial outcomes given the two patent bypass openings through the Trabecular meshwork designed to create multidirectional flow through Schlemm’s canal. Finally, feedback and results reinforce the products supra-relative safety profile and its minimally invasive tissue-spearing procedure. In 2018 we grew our robust by a clinical literature that is unrivaled within the MIGS category. Our clinical library now consist of 104 peer-reviewed studies supporting the performance of our technologies including a total of 38 studies on iStent inject or multiple iStent therapy and 18 clinical publications specifically on iStent inject. These data sets continue to confirm the products ability to achieve sustained IOP reductions that are equivalent or better than the U.S. pivotal trial results. By now many of you’ve seen the results from Dr. Hanger of Germany published in Ophthalmology and therapy. In a case series study of 81 eyes implanted with iStent inject in combination with cataract surgery. His data showed a Mean IOP reduction of 37% to 14.3 millimeters of mercury and a 68% reduction in medication for three years post implementation. Our recent presentation of the Asia-Pacific Glaucoma Congress by Dr. Clement showed a 165 subjects implanted with iStent inject in combination with cataract surgery, achieved the Mean IOP reduction of 23% to 14.2 millimeters of mercury along with the 72% reduction in medication use at one year. Another recent publication in Ophthalmology and therapy by Dr. Guides compared the use of iStent inject in combination with cataract surgery versus the first generation iStent. In his study of 73 subjects and six months post implantation the iStent inject cohort achieved a Mean IOP of 12.7 millimeters of mercury versus iStent cohort Mean IOP of 13.9 millimeters of mercury. In addition 100% of subjects in the iStent inject cohort achieved an IOP less than 18 millimeters of mercury and researchers observed the mean medication burden reduction of 83%. Dr. Guides publication represents an important milestone for blockers marking the 100 peer-reviewed publications our technologies. iStent inject represent the first potential cascade of new product and platform introductions over the next five years. In 2018 we achieved several critical pipeline milestones most notably commencing two key pivotal clinical programs for iDoseTravoprost and iStent infinite. The iDoseTravoprost Phase III IND clinical program consists of two concurrent prospective randomized double-blind pivotal trials that will enroll approximately 1100 ocular hypertensive or open-angle glaucoma subjects across roughly 100 investigator sites primarily in the United States. The studies have a primary efficacy endpoint of non-inferiority to topical timolol of 12 weeks and the primary safety end point one year. Similar to our Phase II iDose study, we’ll follow the Phase III subjects for three years post implantation in order to evaluate sustained longer-term efficacy duration along with safety. Patient enrollment for the iDoseTravoprost studies is proceeding in line with our expectations to support our FDA approval target of late 2021 to 2022. Based on our actions with the ophthalmic community and feedback from clinical investigators participate in the iDose Phase II studies, we believe there are substantial appetite for a viable continues glaucoma drug and delivery treatment option to combat the ubiquitous problem patient non-adherence to topical medication. It comes with no surprise given several large-scale public studies that have demonstrated that roughly 40% to 60% of patients do not adhere to the prescribed medication regimen. Further, as measured by pharmacy data of more than 10,000 subjects in glaucoma adherence and persistent study our gaps only 10% of patients who were prescribed by glaucoma drops were persistent with therapy without any gaps and refilling the prescription over the following year. In the same study 27% of patients who discontinued their medication side of hyperemia as their main reason. Hyperemia is a frequent and disturbing side-effect because topical, glaucoma drugs require a relatively high loading dose to get through the preclinical [ph] tear film. However, because iDose is secured and anchored into the square behind the cornea it is designed to create therapeutic index capable of providing IOP reductions over sustained period of time in a micro-elution rate. In short, since iDose delivers the drug from inside the eye rather than on it surface, we believe it has the potential to significantly reduce hyperemia and other side effects often associated with topical drops while ensuring 24x7 compliance. This was valid -- this was validated in our Phase II 12 month interim data analysis in which no adverse events of hyperemia were reported in either iDose cohort. In addition we believe iDose has the potential to significantly expand our future addressable markets by 3 million eyes annually in the US alone. Given its potential for broad label and recurring treatment algorithm we envision an opportunity for iDose to pave the way for a new treatment algorithm where surgeons could use it alone or in combination with other therapies including our portfolio of surgical devices, to more effectively manage patient IOP. Further, we believe the powerful iDoseTravoprost data available thus far underscores the potential of our novel drug delivery platform to produce future generations of sustained therapies for glaucoma and potentially other ocular diseases. We are pursuing these opportunities through internal R&D programs along with pharmaceutical development agreement we entered into 2018, with the Western technology Institute. This agreement facilitates joint research efforts using compounds from the proprietary Rho-kinase or ROCK inhibitor compound library. While our collaborative efforts remain in the early stages, we’re encouraged with initial discovery progress being made for potential new ROCK compound capable of being use on the iDose platform that could have a highly synergistic mechanism of action to a prostaglandin. While we actively recruit our iDose pivotal trials, patient enrollment continues for the five, 10-K pivotal trial for iStent infinite. Our $0.03 standalone product for advanced and refactory glaucoma patients. As a reminder this is a prospective multicenter, single arm clinical trial that will roll roughly 65 practice subjects. We continue to target FDA approval for iStent infinite in the late 2020 2021 one time period. Finally, the pivotal trial data set analysis on initial preparation for FDA discussions for iStent Supra, our Suprachoroidal stent is expected to be completed over the coming months. We look forward to examining the full data set with the FDA and determining the most appropriate regulatory and potential commercial path forward for this product. Our notable clinical and regulatory progress in 2018 leads us well-positioned to further advance our transformational pipeline in 2019 and beyond. We believe the powerful platforms we are building combined to represent the most comprehensive portfolio in the global glaucoma landscape, a portfolio capable of meeting the needs of the entire disease state continuum from ocular hypertension to refractory glaucoma, both in combo cataract procedures and through a variety of mechanism of action treatment approaches. Throughout 2018 we also made meaningful progress to expand and strengthen our national business, not only did revenues grow 61% in 2018 over 2017 but we continue to successfully optimize reimbursement in key markets to support future growth and to resolve several reimbursement challenges that often remain a fundamental issue and pioneering new international markets. In Australia and the permanent reimbursement code covering the implantation of iStent and iStent inject in combination with cataract surgery became effective on November 1, 2018. In France, we are delighted to learn that after more than five year process, the French health authority designated iStent inject to be registered on the list ensued or add on list which provides hospitals with reimbursement coverage to use the new technology. We are now working with the French Administrative of Health Pricing Committee and hope to finalize pricing sometime in the first half of this year. Our international commercial strategy in 2019 will be more of the same. We plan to continue to support and grow our quality experience surgical sales teams, we’re working to optimize the reimbursement coverage and payment landscapes, trained surgeons and leverage our compelling clinical data to grow MIGS adoption and drive deeper penetration. In addition to the 16 international countries where we had a direct market presence today and continue to add resources, we continue to evaluate and make initial investments and potential future direct national markets for us were favorable market opportunities and reimbursement path for success. While we will remain bullish about long-term U.S. growth opportunities, it is important to remember, it takes time to pioneer completely new market in each of these international countries and potential unforeseen setbacks may arise through this early market building our product phases. To that point, in the U.K. the NHS has recently proposed reductions in reimbursement for a broad range of medical devices including glaucoma devices set to become effective in April 2019. As always we will work with the NHS and medical community in an effort to secure fair reimbursement for customers. Finally, our 2019 focus will be on continued commercial execution in the U.S. and abroad, accelerating our clinical and regulatory efforts, expanding our core research programs and implementing improved enterprise systems and facilities infrastructure to support our future cadence of global growth. So, to the last point, as we discussed on our third quarter call, 2019 will be an important investment year for us. Late last year, we’re excited to announce our plan to shift our corporate headquarters to Aliso Viejo where our new campus will be designed to provide Glaukos with customized, state-of-the-art facilities to support the pharmaceutical and medical device innovation that is necessary to achieve our long-term growth objectives. Combined, we believe the investments we’re making today will help strengthen Glaukos’s ophthalmic pharma and device leadership position, fuel our continued growth and solidify the foundation from which our franchise can significantly expand over time. So, with that, I’ll turn the call over to Joe for summary of the fourth quarter and full year financial results. Joe.

Thanks Tom. As noted earlier net sales for the fourth quarter of 2018 were $54.1 million a year-over-year increase of 30%. The U.S. represented 84% of our sales in the quarter and international 15%. In the U.S., fourth quarter 2018 sales were $45.3 million, up 25% in the same period a year ago. U.S. sales in the quarter primarily benefited from the launch of iStent inject and the competitive market development late in the third quarter. Outside the U.S., fourth quarter sales were $8.7 million, an increase to 63% in the same period a year ago. Our international business continue to outperformance expectations driven by broad base growth. Our gross margin in the fourth quarter with 86.8% versus 88.9% in the same quarter in 2017, the latter which included a one-time benefit related to an inventory valuation adjustment. We continue to expect our gross margins to remain in the mid 80% range going forward as our product mix shift increasingly to iStent inject in the U.S. SG&A expenses in the fourth rose 24% to $32.1 million versus $26 million in the year ago quarter. This rise reflects higher personnel and other costs related to the ongoing expansion of our domestic and global infrastructure primarily in our commercial and international operations and investment associated with iStent inject launch. R&D expenses rose 23% in the fourth quarter to $13 million versus $10.5 million in the same year ago period. This rise reflects primarily the cost of additional personnel as we’ve expand our pharmaceutical R&D capabilities and within clinical research where in particular the direct costs associated with the iDose trial enrollment continues to increase. We finish the fourth quarter with net income of $1.8 million or $0.04 per diluted share compared to net income of $1 million or $0.03 per diluted share in the fourth quarter of 2017. As of December 31, 2018 we had cash, cash equivalent, short-term investments and restricted cash of $149.3 million compared $137.8 million at the end of the third quarter of 2018 and $119 million at the end of 2017. While we were pleased by the profitability and cash flow generation of the business it is important to remind you that we move into 2019, our primary focus remains on long-term growth as we prudently invest to build the MIGS market drive increased penetration of our iStent and iStent inject platforms globally, drive our robust pipeline initiatives through necessary clinical studies and programs. Advance new opportunities into clinical studies and build our global infrastructure. As we said before and consistent with Tom’s remarks, we do expect CapEx to increase substantially in 2019 as a result of the investments we are making across the business. Notably with the build out of our new headquarters facility and upgrades in our global systems capabilities, including the implementation of improved enterprises systems to broaden our technology capabilities to support future growth. Now, I'll briefly recap our full year 2018 results. Total net sales were $181.3 million, a year-over-year increase of 14%, U.S. net sales were $151.7 million, a year-over-year increase of 8%. International net sales were $29.6 million, a year-over-year increase of 61% and approximately 16% of total 2018 net sales versus roughly 12% in 2017. Our 2018 gross margin was 86% versus 87% in 2017. SG&A expenses for the full year rose 24% to $119.5 million versus $96.3 million in 2017. R&D expenses rose 28% for the full year to $49.7 million versus $38.9 million in 2017 excluding the one-time in process R&D charge of $5.3 million. Our 2018 net loss was $13 million or $0.37 on a diluted per share basis compared to a net loss of 100,000 or $0.00 per diluted share in 2017. As Tom indicated earlier we are introducing 2019 net sales guidance of $220 million to $230 million. This guidance takes into account our expectations for organic growth, the updated MIGS market landscape and competitive dynamics. The new doctor training dynamic associated with our inject launch and the expansion of our international sales which we now expect to be in the range of $36 million to $30 million for the full year based on foreign exchange -- currency exchange rates. Finally, as we think about our operating expenses in 2019, we expect to modestly expand our SG&A spending from Q4 levels to support the inject launch international efforts, and increase R&D spending as clinical cost increase to support our pivotal trial activities. With that, I’ll now turn the call back to Tom.

Okay. Thanks Joe, so just to recap, Glaukos is pursuing an aspirational mission to transform glaucoma therapy. We made significant strives to advance this mission in 2018 as the U.S. approval and commercial launch of iStent inject along with the commencement of the key pivotal clinical studies for iDose Travoprost and iStent Infinite. While the progress we made to-date is important. We believe our future opportunities will remain robust. The powerful platforms we are building a sustain pharmaceuticals micro-scale surgical devices, diagnostics should help us evolve into a hybrid ophthalmic pharma device global leader capable of providing optimized drop-less treatment approaches for effectively managing glaucoma and potentially other ocular diseases. I believe we’ll remain in the early stages of unlocking the Company's long-term value potential and I’m excited for the opportunities that lie ahead. So with that, I’ll open the call to questions. Operator?

[Operator Instructions] And you first question comes from Brian Weinstein with William Blair. Your line is open.

Hi, guys. Thanks for taking the questions. Just how we just started on the guidance, the 220 to 230, obviously you guys said, very strong fourth quarter and just sort of annualizing that with just along within the range there. So, can you just remind us about how we should be thinking about seasonality coming in here? And what -- thinking through the other parts of the guidance in particular, anything that you can provide on pricing that you guys are thinking on inject and any other dynamics that we should be considering?

Hey, Brian, it’s Joe. So maybe I’ll start off and I’ll start somewhat of a high-level and than if we want to dive in any of the other subjects, you certain rise there, we can do that. I think as we think about guidance for the year as you know pretty consistent with past practice, we run and look at a lot of different scenarios and we think about in the context of a standard build curve distribution of potential past for the year. And we take a look at that and decide where we’re going to land. In the context of 2019 there’s ample of things, none of which will surprise you that are driving our views on the year. Core market growth remains healthy, but we have to analyze that, think about various scenarios there, in particular as we think about the dynamics new doctor training. CyPass share were capture. It continues to be in line with the expectations and in our prior communications we expect that over the course of 2919 as well. The inject conversion process, right, we’ve talked about that I think in the prepared remarks we discussed that we remain on track there as well and we expect that to continue to phase in over the course of first half of 2019. Competition, obviously we continue to assume, trying and trialing associate with full scale launch there. However, to date they really haven’t fully commenced the full launch, but we have to factor that into the views of 2019 guidance. Now in the international front, we continue to have broad progress, but we have to factor in the inevitable setbacks with the small company and we’re building brand new markets as Tom alluded to you in 15 [ph] distinct country. So we continue to take a cautious view of that progress when we look forward.

Got it. Thanks. And then, as far as some of the investments that were made, you’re thinking about making rather you talked about some of the CapEx investments and other things, but can you give us an update on where the sales forces right now and the investments that you’re specifically making both domestically and internationally to expand that sales force?

Hey, Brian, it’s Chris. We continue to look at these things opportunistically and where we see an opportunity we do add people, is an example that we added some people, some sales reps in France. At the U.S. level we were still in the high – mid to high 50s with sales reps and 90 overall in terms of sales professionals and those numbers pretty much near the international markets as well. So we'll continue to look at and where we see opportunity will add people as needed.

Thanks, Chris.

Your next question comes from the line of Robbie Marcus with JPMorgan. Your line is open.

Yes. Thanks a lot and congrats on the good quarter.

Thank you, Rob.

Joe, maybe I can follow-up on – maybe I could follow-up on that last question and ask it in a different way. So, I know you don’t give quarterly numbers, but maybe help us understand what the company did in the U.S., maybe what market growth was in 2018? If you could help us out maybe on a one-time look at volumes and pricing for the year, through was up at year-end and help us understand what you’re assuming from market growth in 2019 and those volume price dynamic as well? There’s a lot of moving parts and I think would help understand the guidance little better.

Yes. Absolutely, Robbie, maybe I’ll first address the market related questions then I can circle back to the kind of quarterly cadence of component what you and Brian were asking. So, first from a market standpoint, I think the year and that shaping up almost exactly as we had predicted it at the outset. So, I would say that for the year we saw a market growth in the neighborhood of 20%. To get there as you can imagine, that means that fourth quarter was somewhere in the mid-teens from market growth perspective. Again as we sort of predicted and expected beginning of the year and entirely driven by our new doctor training efforts and the slowing of that associated with the iStent inject conversion. As we think about that turning the corner in 2019, we have to take into consideration that we have both the lag effect of the lack of new doctor training in the second half of 2018, as well as new doctor training being slowed or the continuation of that being slowed in the first half of 2019. And we think about all those pieces and we look at the opportunity in 2019 we see mid-teens market growth for 2019 time period. That’s on the market side. We can talk about individual drivers later in the call. On the quarterly cadence component, you’re right, there are fair number of puts and takes that we can discuss. I think that the net of that and why we don’t get quarterly guidance is that we would expect that the 2019 year in the U.S. will actually somewhat mirror the traditional cataract seasonality. There’s a reminder, as we had a couple of years here where this has been a little bit of different pattern that typical cataract seasonality happens, about 22% of cataract volumes happened in the first quarter, 25% happened in the second, third quarter and 28% in the fourth quarter. So, I would think that’s probably the best indicator you could have how we think about the rollout of 2019.

Great. And maybe just one other component for 2018 that I think would be helpful. What do you think de-stocking number was?

Yes. So it’s an interesting and obviously we talk about this in the past, it’s hard to pinpoint the exact number. We can look at it in a fairly macro sense. And I will say this. And we talked about there being some destocking at the tail end of the second quarter that continued into the third. Its our believe that in the fourth quarter based upon the analysis we’ve done here that that actually had reverse itself a bit particularly in the second half of the fourth quarter where we start to see a little bit of restocking. And I’ll say that restocking is probably measured in two new a $1 million plus of revenue that was coming back in some of our larger customer they can put it over to iStent inject.

That’s really helpful. And then maybe if I could just squeeze in one last one for Tom and Chris. If you guys could just give us your thoughts form the field and what doctors are telling you in the uptake of inject how they like it? And just maybe comment on what you’re seeing from competitive launches out there? Thanks a lot.

Okay. Hey, Robbie, it’s Chris. We couldn’t be more pleased with the execution and the rollout strategies of the iStent inject launch. Things are going well and its really validating what’s been seen in the clinical literature and what we’ve seen internationally with iStent inject. Doctors are getting good results. They’re pleased with the IOP reductions, their safety profile and the ease-of-use of the product. So in short it’s going not exactly but very much inline with what we expected.

Your next question comes from the line of Larry Biegelsen with Wells Fargo. Your line is open.

Hey, guys, thanks for taking the question and congrats on the good quarter. Hey, Joe, just a follow-up one on the guidance for Q1, I mean, it looks like you’ve got about -- based on what you’ve said, about $188 million at the midpoint for the U.S. in 2019, 22% of that's about $41 million, you just did 45 in Q4, but the growth rate slowed. So that $41 million, if I’m doing the math right is about 23% versus the 25% you did in Q4, but it would seem, Joe, you could actually do better given the stocking issues in the second half of the year. So, why would on a year-to-year basis growth slowed a little bit in Q1? And I had a follow-up.

Sure, Larry, I mean, obviously its difficult on the slide to full all the calculations we just did there, but conceptually I think what we’re looking at, first and foremost if you alluded to its always a little bit difficult because we go from our seasonal high quarter of Q4 into our seasonal low Q quarter in Q1 and in particular in Q1, the dynamics behind the scenes are that we see a lot of the volume actually happen in month of March in particular. So, that informs a little bit of where the guidance as we sit here today and think about that. But in general the business remains healthy. Obviously, we’re expecting to experience an uptake in some of the competitive trying and trialing activities that would come from the competition and sometimes international business can be a bit more speculated about the outside of the year as well.

All right. Thanks for that. Sorry for the math question there. So on international, how big is the UK, how big is the reduction in the reimbursement? And just lastly, Tom, you could probably have anticipated this question, but what’s the next step in the Ivantis litigation? And I guess given the strength of the patent side at least we thought the strength of your patents, we were surprised that you haven't requested a preliminary injunction. Is there anything you can share with us? Thanks for taking the questions.

Yes. Why don’t I go first and attack that head-on. So just to give everyone kind of a refresh you on where we are, we’re really kind of in the relatively early phases of litigation with Ivantis. As you know we filed our preliminary claims against Ivantis in April. The trial dates has been set for February of 2020 and over the course of this year you can expect that they’ll be discovery from both sides; depositions and claims construction prior to the trial. You also know that we filed a summary judgment to get a finding of non-infringement on the patent that Ivantis had started against us in litigation and the Court did grant Ivantis some additional time for discovery. But we expect that judge will hear that motion again probably sometime in March of this year. We are on track with where we are in the litigation. I'll tell you that as you know we been consistent in our position that we’re not going to publicly talk about our IP strategy, but I will tell you that we’ve also been very consistent in that strategy and we remain very, very confident in our position.

It’s Joe. I’ll start up with the UK question and Chris can add some color as well. We’ve obviously never broken out specifically individual countries revenue contribution. But what you have heard from us especially over the last year plus is that the UK has been an important driver of the overall growth for international business in particular since we launch iStent inject there at the latter part of 2017. So it’s an important market for us, but would not quantify that publicly.

Can I add some color to that?

Okay, sorry, Chris.

To add some color to that. Any chances proposed a cut to all of that. NHS has proposed a cut to all glaucoma devices, including us and this is now under review and there's that commentary period. To be specific, it would affect the facility fee right now being reimbursed at $2000 and would go down to $1200 and this is something we're obviously working with the Congresses and individual physicians. And as I mentioned, we're in the commentary period and it is a proposal. So we'll see what happens over the next couple of months.

Thank you.

Your next question comes from the line of Matthew O'Brien with Piper Jaffray. Your line is open.

Hi guys. This is Drew [ph] on for Matt. Thank you for taking the questions. And I know in the past you've been hesitant to disclose CyPass capture specifically, but now that you've had another quarter here, how should we frame expectations in the 2019 and should this really be a accelerating piece going forward?

Hi Drew, it's Joe. I'll start off with that, and if others want to add in, and they can. I think with respect to CyPass site pass and their share recaptures, it's really gone as expected and sort of as we communicated even from the early days post to the recall announcement. So nothing new there in terms of what we experienced in the quarter. You know we are we are capturing the majority, the vast majority of those procedures, but it's not a one-to-one. And for those procedures that are not being captured often they're being lost at a later stage for in-therapy devices. And we would expect there no reason not to expect that would continue in 2019 as well.

Okay. And then down just….

And then this is Tom, this is Tom. I would just add that, because in the real world we're seeing perceptions that the real world results delivered by iStent inject are really significantly better than what we see saw in the iStent pivotal trial or for that matter for iStent real world data. I think that that makes iStent inject a more compelling opportunity for patients that previously were more relegated to CyPass for more moderately advanced patients. I think that just puts us in better position to capture the majority these patients.

Okay. Great. And then on [Indiscernible] I believe that that device could be on the market the next two years or so and just targeting more severe patients initially, but I believe there are also some mild to moderate patients that don't quite achieve IOP reductions as necessary with inject, couldn't resist a three stent system like inject be helpful to these patients? And if that was the case, would a separate approval be necessary to target them? Thank you.

Yes, okay. So what I would tell you again is that the iStent Infinite is undergoing a 510-k review for refractory patients as you’re all aware. And as we move forward, we'll seek approval for that indication. And as you know, surgeons wants this product when and if it is approved, will have the discretion to use it in patients that they see fit or where they think they can achieve desirable intraocular target pressures. I think, what we need to be cognizant of is to make sure that we have the appropriate coverage, where our payers will pay for that device in ranges that are outside the approved claim. Obviously, we cannot and will not promote for any indication that's outside our approved claim, but we suspect that with the three stent alternative there will be some surgeons that will see a desirable need to use an iStent Infinite for patients where they are seeking a little bit additional reductions in pressure to reach a lower intraocular target pressures.

Okay. Thank you.

Your next question comes from the line of Jon Block with Stifel. Your line is open.

Great. Thanks guys. Good afternoon. Maybe two or two and a half versus price. Joe, I believe you usually give us some color on price historically. I don't know if I missed it, but how is 4Q 2018 U.S. ASP versus a year ago? And then in 2019, I'm guessing you're going to have mix shift in your favor with inject. Will there also be any increase in price on the underlying stent themselves? And then, I've got a follow up.

Sure. Thanks, Jon. Hi. So I think for the fourth quarter, sales 2019 the reason why I didn’t hear that in our prepared market, there was a very modest benefit in the fourth quarter on a year-over-year basis coming from the combination of the mix shift and -- just generally pricing with inject device. And as you alluded to in the context of 2019, you obviously do get a bit of benefit from the mix shift as we have been pretty consistent saying, that the iStent inject is a premium product, and that we would expect to get a modest price premium for that device. You know it's not -- it'll phase in of course -- of course if the course is – in 2019 as we continue to convert doctors and accounts over types and inject and we’ll see the full benefit of that obviously in 2020, once we've got the vast majority of our surgeons convert.

Okay, great helpful. Thank you. And then just to shift gears, can talk a little bit about the competitive landscape, I mean, any update on Ivantis what you are or are not seeing there. What's reflected in your guidance? I think to build on I think was Brian's question earlier if you sort of take that four two number, and the U.S. annualize it add in your internationally, you sort of scrape that two 20ish type of numbers, and then maybe you could also talk to what's the swing factors Joe between the low end and the high end of your 2019 guidance. Thanks guys.

Hey Jon, it's Chris. In terms of Ivantis, we still there's still been limited in their activity but we do expect them to ramp up and scale up through the course of the year. They've been very prominent in some of the major meetings in the first quarter. But at this point in time they still seem to be doing a limited launch, a controlled launch to the best of our knowledge they have between 10 and 12 representatives. And then Jon, the second part of your question as you think about 2019 and what sort of frames the low versus the high, I really sort of where we started this call with which it's a little bit of everything, right. So when we talk about mid-teens growth and some of these are interrelated, right. The piece in which we get the doctor's converted over to inject, right and those last sort of a handful of docs that are -- that are out there as we get towards the middle part of the year. What that does or doesn't mean in terms of our ability to get back and training new doctors is focusing on same store sales growth will have a pretty big impact both on the core market growth as well as the pricing question that you asked previously. On CyPass, to Tom’s point, right we run scenarios around what we're seeing today and how that may change as we look forward with inject being in the hands of more surgeons, and our ability to capture a little bit more. On competition, you sort of just hearing it from Chris. I mean, it's still early days, but we have to obviously factor in scenarios that involve increased trying and trialing over the course of the year is they we would expect that they would more formally commit the full launch. And then internationally as we talked about other things there whether it's the U.K. example or those that are that are smaller that we don't call out or those that are unforeseen right now, to date, we've done a great job. I think as a company in these markets working our way through those resolving them with minimal disruption of business but as we think about 2019 we have to factor that in as well as we think about the high to the low end.

Okay. Very helpful. Thanks guys.

Your next question comes from the line of Chris Cooley with Stephens. Your line is open.

Hey good evening and congratulations on a great fourth quarter. I’ll keep it literally to two. Could you help us define significant, when you think about the step up in CapEx this year in 2019 and then maybe I'll do the same thing everyone else has. In regards to trying to pass guidance you know we look at the OUS component, you just put up 63% in the fourth quarter and while the UK may represent a fairly material headwind you're expanding into new markets and you have continued just overall adoption, the guide only implies 20% to 26%. So maybe you could help us think about what is and isn't factored in that OUS component of your top line guidance for 2019. Thanks so much.

Sure. So I'll start with the latter part of the question, we focus on that. So from the international standpoint, obviously a couple things going on there. One, we've talked about now at length the various things we have to factor in. If you look back historically on the international business, you've seen a business that that grew 135% in 2016. 95% still in 2017, 60% roughly in 2018. One of the challenges in 2019 from a growth rate perspective, when you're looking at that way, is just that from a comparability standpoint 2018 was the first year in which all of our international markets were really running at full speed for the entire year. You recall that the vast majority of the 60 international markets we actually entered into over the course of 2017. So we had a little bit of favorable comparability as we looked at 2000 as we went through 2018. That won't be there for 2019, but beyond that, you know we do factor in things we said earlier about whether it's the U.K. or other potential setbacks in these markets as we look to grow them. Oh and sorry. You also asked Chris about CapEx. So for us, we did about $10 million of capital expenditures in 2018 that was that was broad based. As you'll see in our 10-k when it's filed. For 2019, our best estimate right now is that that may approach them in the neighborhood of $20 million of capital expenditures. But I want to caution this in that, there's a lot of variability in that, that has to do with the timing of the build out of the Aliso Viejo headquarters and the receipt of some of the associated GI allowances, which are pretty substantial there. So there could be some variability there, and I would expect that to be fairly back-end loaded in the year.

Thank you. Appreciate it.

Your next question comes from the line of Joanne Wuensch with BMO Capital Markets . Your line is open.

Yes hi. This is Matt Henriksson in for Joanne. First question, with regards to your commentary on opportunistically training new physicians, that sounded new from previous commentary. So what's the strategy about going into 2019? Are you going to expand these opportunistic training, and then is this factored into your 2019 guidance?

Hi Matt, it's Joe. So first and foremost, yes, of course it's all of our doctor training expectations by quarter are factored into the 2019 guidance. Well maybe the first time you've heard that in Tom's prepared remarks, we've often just said that one of our strategies would be to opportunistically hire or train new doctors alongside the bar is high, as you can imagine because the primary focus first and foremost from the beginning and through the day is on converting our existing surgeons. But, there are exceptions to that. We've been very pleased with the reception that we've received in the community and the desire to be trained on inject even from those surgeons who’ve not done MIGS in the past. So we've taken advantage of that in cases. And so we were just simply pointing that out as a part of what's happened in the fourth quarter.

That's helpful. And then just back to pricing, are you seeing the MACs be more willing to cover the ad on code for the second stent for iStent inject. Thank you very much.

Hey, this is Chris. And at this point time there is just one MAC that is consistently covering the ad on code 0376T. The other MACs have been variable in terms of their coverage, both from a rate perspective and whether or not they're covering it. It's something that we're going to continue to pursue, something that we're hopeful of, but we do feel that the 0191T coverage of the iStent inject from a professional fee standpoint is healthy enough for these doctors to want to use the best MIGS procedure out there. So it's something that we're not counting on, but it's something that we're pursuing . And the 0376T code is not something that we factor into our guidance in the context of, it would be upside if that continues to make progress.

Your next question comes from the line of Ravi Misra with Berenberg Capital Markets. Your line is open.

Hi, thank you for taking the question. So I guess, I have one to kind of beat a dead horse on the guidance again and then another on operating expenses. So just I think a lot of us are trying to understand here just whether there is a realisticness or conservatism based into guidance and based on you know some of the questions, can you help us calibrate how we should be thinking about in our models like, is the way to kind of think about this that you have this mix shift driving. ASPs slightly higher offset by a flattish surgeon trainings with kind of volume growth in existing accounts above levels exiting last year, kind of a good way to get to the midpoint of your number.

So, hey Ravi it's Joe. I would say as we think about the set up for the year, I'm not sure I would necessarily say it’s as much price driven as maybe it sounded like the way you set that up. I think, it's fairly broad in terms of the drivers that are taking our business forward in 2019. And as I mentioned earlier, that's a combination of the core market growth CyPass share recapture, the pace in which we convert the remaining physicians over to inject and start focusing back again on same store sales and new doctor training. The competitive landscape and how that will evolve over the course of the year, and then obviously the international business there. Also to reiterate again, what we've always said in respect to setting guidance, and we look at lot of scenarios. We look at what that means from sort of distribution of Bell curve if you will, and we try to be – have our guidance to be a bit less than center as you expect, but we really do take a thoughtful approach in looking at various fast-forward for the year before we set the number and give it you guys.

Great. Thanks. And then just my follow-up, you showed some nice leverage on the SG&A line there in the quarter. Just wondering if that’s kind of one-time thing or would you guys delivering this profitability in net income. Help us think about maybe where the leverage can go in the model, if you go to that top end or the bottom end of your range? Thank you.

Well, I think one thing that take a step back on the fourth quarter from an operating perspective is obviously was a fairly material change in the marketplace, competitive landscape heading into the fourth quarter. Its always hard to change your investments you’re making in business as fast as obviously, what changed in the commercial market place. Having said that, you heard from Tom, and you heard from me, we’re going to continue investing heavily in 2019 both from an infrastructure perspective and the commercial infrastructure and the increased spending around the clinical trials, iDose, Infinite et cetera, so we’re going to continue to make those investments over the course of the year. Growth there and operating spending will probably look something fairly similar to what you saw percentage wise in 2018, but as you think about longer term in operating leverage, that’s there. We’re clearly still building the pieces associated with our international business, our infrastructure, that we’re still in the middle of that. But having said that with our gross margin profile and just the dynamics of our business we see a lot of operating leverage in the years ahead in particular as we get another side of the iDose launch from the investments that we’ve got associated with that.

Great. Thanks a lot.

There are no further questions at this time. I’ll turn the call back to presenters.

Okay. So this is Tom. I want to thank you all for your time and attention today and always for your continued interest in Glaukos. Thanks and goodbye.

This does conclude today’s conference. You may now disconnect.