Glaukos Corporation (GKOS) Q1 2017 Earnings Report, Transcript and Summary

Welcome to the Glaukos Corporation’s First Quarter 2017 Financial Results Conference Call. A copy of the Company’s press release issued after the market close 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] This call is being recorded and an archived copy replay will be available online in the Investors Section at www.glaukos.com. I will now turn the call over to Sheree Aronson, Vice President of Investor Relations and Corporate Marketing. Please go ahead.

Hello, everyone. Joining me today are President and CEO, Tom Burns; Chief Financial Officer, Rich Harrison; and Chief Operating Officer, Chris Calcaterra. Following our prepared remarks, we’ll open the call to questions. To ensure ample time and opportunity to address everyones’ 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. Before we begin, let me remind you 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 iStent product, our pipeline technologies, our U.S. and international commercialization efforts, the efficacy of our current and future products, and the competitive market position, financial condition and results of operation. 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 SEC filings for more information about these risk factors. You’ll find these documents in the Investors section of our website at www.glaukos.com. With that, I’ll turn the call over to Tom Burns. Tom?

Good afternoon, and welcome to everyone joining the call today. Glaukos is off to an excellent start in 2017 with first quarter net sales of $35.9 million, up 55% versus the year ago quarter and marking our fifteenth consecutive quarter of more than 40% year-over-year growth. Our top line performance reflected primarily continued strong domestic/international iStent unit growth along with the 2017 increase in Medicare reimbursement which facilitated an iStent price increase for U.S. ambulatory surgery centers or ASCs. Given this performance, we are raising our 2017 full year guidance to a range of $162 million to $167 million which implies a 42% to 46% growth rate versus 2016. The first quarter results demonstrate not only our continued progress in forging an entirely new glaucoma treatment class but also the ability of our global team to execute on our core growth objectives which are the drive adoption -- U.S. adoption of iStent in combination with cataract surgery; two, to fortify our MIGS leadership with next generation iStent devices; three, to advance our novel iDose injectable drug delivery platform; and four, to expand our direct sales operations into high-value international markets. So let’s start with progress during the quarter to drive U.S. adoption which involves training new surgeons on the iStent procedure while helping existing practices increase utilization rates. Our team is focused on the roughly 5,500 ophthalmic surgeons who perform most of the estimated 3.9 million annual U.S. cataract procedures. At the start of 2017, about 2,400 surgeons have completed iStent training and through the first quarter, we remained on pace to reach our 2017 goal to train an additional 700 doctors by year end. We continue to focus considerable sales resources on a proprietary list of high volume cataract surgeons. This strategy is helping to fuel increased iStent volumes along with a variety of iStent education and awareness building initiatives such as our professional and consumer marketing campaigns, mix fellowship and residency programs, specialty sales team targeting teaching hospitals and outreach to the optometric community. As you know, in the first quarter, we implemented a price increase for iStent devices sold to U.S. ASCs. The pricing change corresponds to the approximately $790 or 35% increase in Medicare facility fees these ASC customers began receiving at the beginning of 2017 for a combined iStent and cataract procedure. In setting 2017 selling prices, we followed our longstanding methodology which bases pricing on the specific Medicare reimbursement the ASC receives and is designed to equitably share iStent facility fees across all customers. Recall that this ASC reimbursement increase came about because the 0191T CPT code describing insertion of a MIGS device into the trabecular meshwork qualified for a CMS device intensive offset. We estimate that roughly 75% of U.S. combined iStent in cataract surgery procedures are performed in ASC setting. Remember that while Medicare facility reimbursement rates for the iStent procedure are set annually by CMS, the professional fee payment surgeon receive for performing the procedure separately by individual Medicare administrative contractors or MACs. Last one, last month one MAC announced a plan to lower the iStent professional fee payment in its coverage area so that the fee would be equal to that paid for performing an SLT or selective laser trabeculoplasty procedure. We’ve been working closely with multiple ophthalmic professional societies to educate this MAC on the demanding surgical skill, precise knowledge of angle anatomy, intraoperative time involved and post surgical care required to implant an iStent device and to provide first hand support for the argument that SLT is not an appropriate comparative to the iStent procedure. While we wait for this MAC decisions, it is important to point out that challenges like these are welcome, they are not unexpected and come with a territory when building a new market with disruptive technology. I’ll turn now to our progress during the first quarter to secure U.S. regulatory approval for our pipeline technologies starting with the iStent inject which is designed to allow a surgeon to deploy two trabecular bypass stents with a single applicator entry in a straightforward click-and-release motion. Not only does this second generation device enhance procedural ease for the surgeon, but implantation of multiple stents facilitates access to more of the collective channels fed by Schlemm's canal with a aim of further reducing intraocular pressure. As you know, we are pursuing FDA approval for two iStent inject versions, one for using conjunction with cataract surgery and another for use as a standalone procedure. Enrollment on the initial phase trial to evaluate safety of the standalone version is completed and we are preparing to initiate discussions with the FDA regarding next steps including the determining a study design for the 500 patient pivotal trial. We are looking at various options that could potentially influence the rate of trial enrollment and completion including subject inclusion/exclusion criteria, follow-up duration and other factors. Our goal is to reach agreement on the pivotal trial protocol late this year. The iStent inject combo cataract pivotal trial is fully enrolled and farther along with the two-year follow-up concluding this August. We are already preparing modules for submission to the FDA with a plan to file our full PMA by year’s end. Ophthalmic surgeons will present several studies highlighting the performance of multiple stents at the American Society of Cataract and Refractive Surgery meeting beginning this Friday in Los Angeles. For example, Dr. Richard Lindstrom will review the latest results from our prospective, non-randomized, open-label international study of 57 open-angle glaucoma subjects on one preoperative ocular hypotensive medication. These subjects had a mean preoperative unmedicated IOP of 24.4 millimeters of mercury and receive two next-generation iStent inject stents in the standalone procedure. At 24 months, mean postoperative intraocular pressure was 14.1 millimeters of mercury and 98% of subjects achieved intraocular pressures at or below 18 millimeters of mercury without medication. This is just one of numerous international studies that show the potential for iStent inject to substantially reduce intraocular pressure and medication burden. In the first quarter, we also completed enrollment in the iStent Supra pivotal trial, which began its two-year follow-up period last February. The iStent Supra accesses a secondary fluid outflow pathway in the suprachoroidal space. A read of the available literature indicates that suprachoroidal stents provide clinical efficacy comparable to a single iStent Trabecular stent, but are often associated with higher risk. Therefore, we believe in the future surgeons will generally use suprachoroidal stents as enhancements to trabecular stents in cases where lower patient intraocular pressure targets are desired. Our iDose drug delivery system has also passed an important clinical milestone with the announcement this morning that we have completed enrollment in randomization in the 150 patient Phase II IND trial. Data will be unmasked after 12 weeks of follow-up then we expect a public read-out in the later part of 2017. The iDose is designed to be implanted through a corneal incision and secured in the anterior chamber where it elutes therapeutic levels of a proprietary formulation of Travoprost for extended periods of time. When depleted, the iDose implant can be removed and replaced in a subsequent microinvasive procedure. We believe, iDose, if approved, has tremendous potential has a viable alternative to chronic daily prescription eye drops, a therapy that is subject to high noncompliance rates, has multiple side effects and may cause cumulative ocular surface damage. We expect surgeons to use iDose alone or in combination with the iStent flow devices to manage desired IOP targets based on each patient’s individual disease stage in progression offering the ability to customize treatment regimens for a full range of glaucoma disease severity. Also, last month we acquired the IOP sensor system assets from DOSE Medical Corporation. System features a micro-scale ocular implant designed to capture and store a glaucoma patient’s short-interval IOP measurements over extended periods of time and transmits this data to the patient’s physician in order enhance treatment decisions. The wireless system, which is designed for ab internal insertion similar to other MIGS technologies, incorporates a rechargeable battery that may allow the sensor to function for multiple years. Glaukos is already building a powerful and unique pipeline using our micro-scale flow devices and sustained drug delivery platforms. The IOP sensor while in an embryonic development stage has the potential to complement our existing pipeline put us on the leading edge of biosensor and micro-electromechanical system or MEMS innovation and ultimately serve as a new platform for the development of additional breakthrough technologies. I will now touch briefly on our progress in international markets where our net sales rose 160% in the first quarter to an all time quarterly high $4.0 million or 11% of total net sales, evidence that our recent investments in direct sales operations are continuing to bear fruit. We established our first international direct sales team in Germany in 2014 and we now are augmenting our presence in Western Europe with direct sales operations in seven additional countries. iStent product launches are underway in all of these countries. We established our second international direct selling team in Australia in 2016 and continue to be pleased with the progress there where we are working through a change in surgeon reimbursement. Recently, the Australia Department of Health conducted a review of the 560 codes on its Medicare benefit schedule and as of May 1, suspended the iStent surgeon fee code. Prior to this suspension, we applied for new surgeon fee code and the ADOH has just issued an interim code that provides continued iStent device reimbursement through the balance of 2017 while our application is pending. This is not unlike the reimbursement issues we face from time to time in the U.S., we have the full support and involvement of the ophthalmic surgeon societies and we are very pleased to see the ADOH move quickly to provide uninterrupted reimbursement for our device in connection with cataract surgery. In Japan, we finalized reimbursement coverage at the end of 2016 and we are now conducting a tightly controlled and glaucoma specialist led commercialized end launch. Part of this effort, we recently hosted a day long training session that took place of our usual online training modules and was attended more than 130 Japanese glaucoma surgeons. These surgeons are now working their way through the reminder of the training process including wet lab work and performing their initial iStent procedures with a support of our Japanese sales team. Our focus in Japan is on converting this nation’s peer-leading glaucoma before expanding to the broader ophthalmic surgeon population. With this approach, our revenue ramp in Japan will likely not be as rapid as we experience when we launched in United States, but with the target addressable market that is roughly one-third the size of that in U.S. We expect Japan will be a significant contributor to our international sales in 2018. Finally, our direct sales team is also preparing for commercial iStent in Brazil with distributors in surrounding key countries supplementing our Latin American presence. Before moving to the first quarter 2017 financial overview, it gives me great pleasure to introduce, Joe Gilliam, who officially assumes his new position Glaukos Chief Financial Officer shortly. As you recall, Joe was previously Managing Director of the Healthcare Investment Banking Group at JPMorgan where he focused on the life sciences industry. He has significant experience in the ophthalmology space including leading the Glaukos IPO for JPMorgan in 2015. I’m very pleased to welcome him and we will ask Joe to give a few brief remarks.

Thanks, Tom. I’m excited to be a part of Glaukos and can’t wait to contribute to the team and company. I look forward to diving into the business in helping Glaukos extend its impressive track record of execution and growth. I’m also excited about the opportunity to become better acquainted with our shareholders and analysts. Many of you I know already, but in the days and weeks ahead, I hope to reconnect and speak personally with many of you and begin the process of building long-term relationships in my new role.

All right, Joe, thanks. And after Joe assumes the CFO position Rich Harrison will remain with Glaukos for the time being serving in an advisory role Joe and helping to ensure a seamless transition of the CFO responsibilities. I have worked with Rich for the last nine years and can attest to his professionalism, dedication and commitment. On behalf of the entire organization I want to thank Rich and wish him all the best in his retirement. Will that, I will pass the call on to you Rich.

Thanks, Tom. It’s been a pleasure and an honor and a privilege to serve Glaukos as the CFO and I’m looking forward to working with Joe in the days ahead in this advisory role. I’m really confident that Glaukos’ best days are ahead and I will continue to follow the company’s progress with great interest and a whole lot of pride. So turning to the first quarter financial performance, as Tom reported, our net sales rose 55% to $35.9 million versus $23.1 million in the same quarter a year ago. Strong unit volume increases worldwide drove the majority of this growth followed by higher average selling prices in U.S. ASCs, which resulted from the 2017 increase in Medicare reimbursement for the iStent procedure. In the first quarter, U.S. sales grew 48% and international sales grew 160%. International sales in the first quarter represented 11% of total net sales versus 7% in the first quarter one-year ago. And for the first quarter of 2017, our gross margin was 86% of sales, same as in the first quarter of 2016. SG&A expenses in the first quarter rose 75% to $21.5 million versus $12.3 million in the year-ago quarter due primarily to higher personnel, travel and costs related to the ongoing expansion of our global sales infrastructure and investment in marketing programs designed to drive iStent adoption. R&D expenses rose 27% in the first quarter to $8.9 million versus $7.1 million in the first quarter of 2016. The rise primarily reflects the cost of additional personnel particularly within our clinical affairs group where the team is managing an increased number of clinical studies and associated investigational sites and study investigators. We finished the first quarter of 2017 with net income of $878,000 or $0.02 per diluted share compared to $897,000 or $0.03 per diluted share in the first quarter of 2016. And at the end of the first quarter of 2017, our combined cash, cash equivalents and short term investments stood at $99.2 million compared to $95.8 million as of the beginning of the year. As Tom indicated, we revised our 2017 net sales guidance to a range of $162 million to $167 million. On our fourth quarter 2016 earnings call, we indicated that we provided ASC customers the opportunity to purchase a certain amount of iStent in December ahead of the 2017 reimbursement increase in corresponding pricing change. We allowed additional such purchases in early January which essentially shifted the previously expected negative impact on our net sales from the first quarter to the second quarter of 2017. I’ll now turn the call back to Tom.

Okay, thanks Rich. So to recap, we are pleased with our start to 2017 and confident in our ability to meet or exceed our goals for the year. U.S. iStent adoption rates remained strong. The reimburse related price adjustment in the ASCs has been well executed and favorably received, and we continue to grow the ranks of iStent trained surgeons. We are also making significant strides to secure regulatory approval for our next generation iStent devices and our novel iDose drug delivery and plan. While we continue to strengthen our pioneering micro-scale ophthalmic device in drug delivery platforms, we are now also in the embryonic stages of developing a capability devices with the acquisition of core technologies from those medical. Finally, our investment in the international expansion is on track delivering current sales that are at/or above internal targets and will be a source of continued growth throughout the planning period. So with that, I’ll open it up to questions. Operator?

[Operator Instructions] Our first question comes from Mike Weinstein from JPMorgan. Your line is open.

Hi, this is Robbie Marcus in for Mike. Congrats on a good quarter guys. Maybe I could start assuming you won’t give us how much was volume versus pricing, but I’ll still ask. And maybe you can help us out here, how much of the new pricing was realized in the quarter versus how much it flow through into second quarter? Was it a quarter and half, 75%, 100% how much of the incremental price increase that you put into place was actually realized in the quarter?

Hi Robbie, this is Rich. I think the way you characterized your question as to how much we’ll answer is probably accurate. We are not going to give color with specifics on how much was volume and how much was price. I would say that volume led the growth followed by the price increase but we’re not planning to get more drilldown further than that. As far as how much of the price increase was realized, I think the way we’d answer that is to say we are substantially through the process of all the discussions with our customers and places where the price increase has been communicated and put into play, it’s in effect but again don’t forget that there are existing contracts from last year that caused it not to be fully executed at this time. And I can’t give you a percentage breakdown as to how – I think what you’re asking is how many customers are currently on the new pricing and how many are still on the old pricing, and I don’t have an answer for that. Today, more – the majority are on the new pricing.

Is there a timeframe you can give us of when you expect it to be 100% implemented?

I’d say by the end of the second quarter.

Okay, that’s helpful. Maybe can you just comment on just at the end there you said that the bullish [ph] buying ahead of the price increase was possibly in 4Q, the negative impact on 1Q. Did I catch it right that didn’t actually impact first quarter and that would all impact second quarter by about $2 million is what we’re expecting here?

Yes, I think you’ve got it about right. The hard part is to really isolate an exact number as to what the impact will be in Q2 because there is a lot of moving parts. We had, as you know, the price changes, we have contracts and we did our best to try to estimate how much inventory was left at the end of the quarter from the buying for lack of a better word at the end of Q4 and the first week of January, but that’s very difficult to do. So I think it’s fair to say that you’re probably in the ballpark, I don’t have an exact figure for you though. And you’re correct, it essentially shift the impact from Q1 to Q2.

Okay. And just lastly, we’re set to get several data readouts for the back half of the year. Do you have any updated thoughts of when we’re going to see top line data from the inject trial and then assuming the iDose data is good, just hypothetically what sort of trial in terms of patient duration should we expect for iDose? Is that something we might see a one year trial with longer follow-up, two year trial like the other products. How should we be thinking about that at this stage?

Yes, let me answer your first question. This is Tom, Robbie. So as I said before, best case we will be able to produce and have data available for really submission and publication by the end of this year. And it appears like we’re going to be able to achieve that, so I’m very excited to be able to announce that particularly with the announcement of those completing by clinical trial as of today. We expect to see some iDose data in the latter part of this year. With respect to iStent inject, as I’ve said before, we would expect certainly with the iStent inject combination cataract trial, we will file our final PMA module by the end of the year but I wouldn’t expect to see top line data until 2018. And I think that will be something that we choose as a strategic asset and when to announce and how to announce but I would expect to see that data in 2018. And with respect to the phakic trial, phakic pseudophakic Phase I trial with iStent inject, remember that safety only data that won’t be unmatched. So we’ll use that to present to the FDA in order to deliberate and open up a Phase III clinical but that did not expect to see top line data from that Phase I trial.

Your next question comes from Bob Hopkins from Bank of America. Your line is open.

Hi, thanks and good afternoon. Can you hear me okay?

Yes, we can Bob.

Hi, Bob. How are you?

Great. So just a couple of questions. First, appreciate the color you gave on the regional MAC in the U.S. and how that process is going. Just wondering two things to follow-up on that, one, can you give us a sense as to when we might hear something on final decision there or next just steps? And then also what’s your view if the professional fee is lower because it’s my sense that frankly that wouldn’t have much impact on demand or the number of procedures, but I’m just curious as to your take?

Yes, so I think it’s a fair question what we’ve announced and as we talked about in the opening comments that one of the MACs has indicated that they may look at reducing fees for the professional service remuneration for iStent implantation to numbers that are similar to laser trabecular plasty which as you know are somewhere in the $230 to $315 range. And so we think that’s a very desperate procedure, we don’t think that the way to compare. So as you recall, we had the same instance happened last year with a MAC that you are familiar with called [indiscernible] and we were able to martial resources to educate the MAC on the true complexity and time involved with doing the procedure. And I think we’re able to overcome some of the initial move to reduce the surgical fee. So while past successes not an indicator of future success, we are in the deliberations and marshalling resources to try and educate Meridian at an appropriate and fair remuneration for the professional service fee for iStent and plantation should be. So as you can imagine, what’s happening at Noridian is opaque to us, it’s behind closed doors, but we are doing all the right things and we are hopeful that we are able to substantiate and come with a fee that provides a fair representation of the complexity involved iStent implantation.

Any sense on timing?

Not really, that’s not in our hands. I think you’ve seen before that announcement was made or an education that they would be looking for a indication of payment adjustment by May 10. And as you know from looking at Novitas and how we approached this in the past, that can change, depends on the deliberations [ph] within the MAC itself. And whether or not anything comes out on May 10, you can imagine we still will be representing and moving to establish a fair and representative payment for iStent implantation.

And then last question I wanted to ask is about the momentum in the business outside United States, previously you gave some guidance about the percentage of total that OUS might represent in 2017. It seems given the success starting off the year that OUS may end up doing franking quite a bit better than you assumed and I just want to – if you could give us a sense for how we should be thinking about the prospects outside United States in 2017, are there hurdles that we should be considering or am I right in thinking about it as a potential source of upside?

Hi, Bob, it’s Rich. Certainly, it’s a potential source of upside as our U.S. sales and it’s been a race between U.S. sales and international sales over the past few quarters. So, I still think we are comfortable that this 10% to 12% component as a mix of our international sales to total sales is still our guidance going forward.

Okay. And Tom is there a venue for the iDose Phase II data release at this point should be press release, meeting, any sense for that?

Yeah, Bob, we’re – the answer is, no, we are currently considering what venue would be best available and relevant for us to make that announcement. So, I would ask you to stay tuned, we will let you know soon.

Fair enough. Thank you so much for taking the questions.

You are welcome.

Your next question comes from Brian Weinstein from William Blair. Your line is open.

Hi, good afternoon. This is Matt LeRew on for Brian. First, I wanted to ask about penetration into office and understanding that your surgeons as they’ve come on year by year will have different levels of penetration into their total number of procedures. Just wondering if you could talk a little bit about the efforts you have to increase the number of surgery the doc has been doing in terms of the potential they could be doing and what you are seeing in terms of a timestamp for guys who have adopted one-year, two-year ago, three years ago?

Hi, Matt. This is Chris Calcaterra. That’s something that we have a great deal of focus on what we call same-store sales growth. We have a number of marketing initiatives that we have put into place both last year and this year, help drive sales within practices of surgeons that we’ve already converted and are fully trained. That along with adding new surgeons is certainly the key driver of our volumes and our sales success along with the U.S. ASC price increase here is also attributable to the growth that we’ve seen. So we have not given any percentages in terms of penetration rates or anything along that nature because of the competitive entrants that we’ve had in the marketplace, but I can tell you that that is a key driver of our success.

Okay. And then wanted to follow-up on the question about OUS and that is obviously you went direct in several more countries this quarter, but was the jump really result of some new doctors that came on in these new countries or high utilization among existing accounts? And then just wondering if you could just generally speaking give us a sense for how many surgeons you have trained outside the United States?

Yeah, we haven’t given the number of surgeons outside United States and we’ve made a decision not to do that at this point because it’s very different from market to market and we haven’t broken out sales by individual country or region, but I think it’s safe to say that the large percentage of the growth came from Germany, Australia and Canada where we’ve direct the longest going back to 2014 and Germany in 2015 and Australia and Canada.

Okay, thanks.

Your next question comes from Larry Biegelsen from Wells Fargo Securities. Your line is open.

Hi, guys, it’s Adam in for Larry. Thanks for taking the questions. I wanted to ask about standalone. What percentage of iStent use outside of the U.S. is within standalone and how much of a surrogate is that for the U.S. once you have a standalone indication here? And then I have a quick follow-up.

Could you repeat the question? I’m sorry.

Sorry, can you hear me okay?

Yeah.

I just wanted to ask about the mix of iStent use outside the U.S., how much of that is within standalone, how much of it is with in combination with cataract and is that a good surrogate for what to expect once you have approval here for standalone in the U.S.?

Yeah, we have a standalone indication in Europe and in Canada. The exact mix is hard to determine. I would say that the majority of surgeons there still do it in combination with cataract surgery as they become more comfortable with the procedure then they move to the standalone indication.

Okay. That’s helpful. Thanks. And then just as a follow-up to that, I mean, how would you characterize the sweet spot of patients being treated with iStent in a standalone setting, just trying to get a better sense for what those patients look like? Thanks for taking the questions.

Yeah, you bet, Adam. So, the sweet spot in my opinion is going to pseudophakic patients. And so when we look at how we believe the adoption with iStent inject in a standalone setting, I think, it’s fair to say that most surgeons will – it will resonate strongly that the first patients they will turn to are patients that they have on medication therapy and that are pseudophakic, those patients that have already had a cataract procedure and have had the implantation of intraocular lens. The reason for that is pretty simply. One, they don’t have an existing crystalline lens, so there is no risk of causing any cataract even as nominal as that maybe. And secondly, the angle is typically wider. Once you remove the cataractous nucleus, you get a nice wide angle and we look at that by Shaffer grade and those are typically larger than what you will see in phakic patients. And so, I think, what you will see as you do your models is – and I’m happy to explain this as we get closer to launch, but you will look strongly at pseudophakic patients, which are substantial portion of the total open-angle glaucoma community and look there first and then you will look on patients who were on multiple medications first, those that are uncontrolled, then multiple medications controlled, going down to combination medications, ultimately to a first line treatment therapy. And so, again, as you do you models and as we get closer, I’m happy to walk all the analysts through how we see the market and how the rate of adoption will occur.

Your next question comes from Matt O’Brien from Piper Jaffray. Your line is open.

Hi, good afternoon. This is JP McKim on for Matt. Thanks for taking the question. I wanted to touch a bit on competition. You saw Alcon launch in Europe earlier this month and then I think [indiscernible] Zen case in the U.S. over the past couple of weeks. So, I just – you guys got the big conference this weekend at ASCRS, I want to know how you are framing up your sales force to deal with the competition that’s probably coming this summer, what you have embedded in guidance in terms of an impact from maybe surgeons trialing some of these new products coming on for the back half of the year? And then just lastly, has it affected your ability to hire reps at all in terms of attracting them from the competitors?

Okay. Hi, this is Chris, I will handle that question. We have – Alcon that they were launching in Europe, we haven’t much activity as of yet. They announced that they had launched in U.S. in October and we haven’t seen much significant activity there. We do expect them to be more active in the second half of 2017 once they secure their CPT code. As far as the ASCRS, we have a number of papers being presented and posters being presented, we also have a MIGS symposium course that we are holding on Sunday night and we continue to be very bullish on our position within the marketplace. Looking at the CyPass, we still continue to hear from our KOLs and from people who have utilized the suprachoroidal stent that it has a higher risk to benefit and the trabecular meshwork and Schlemm's canal conventional outflow is the place to go to first. As it relates to the Zen product, they have had their first surgeries, they are moving very slowly and conducting their surgeries – their first cases with glaucoma specialists only. We do see this product as something that will be primarily used by glaucoma specialists. It is a more – potentially a more elegant approach to a trabecular lectomy or stent procedure and they’ve been very methodical in their approach to launching that product. But I think we will be well prepared. We have not had any issues with loss of sales reps. We are still able to recruit top talent and we are quite bullish on our position in the MIG space now and in the future.

And JP, this is Rich. With regard to your question about the guidance, I can tell you that our current guidance as well as guidance we gave on the last call was fully reflective on any effects we expect to see from pending competition, but not going to be able to quantify that for you.

Great. Thank you. And then one more if I could on inject. It sounds like the inject in combination with cataract is a two-year follow and I just want to get understand, is there any reason why we shouldn’t think of inject standalone requiring to your follow-up, is that kind of the base line expectations and if they ask for one-year follow-up that’s even better, but as baseline to think about inject standalone being two years?

Yeah, I’d probably look at it that way, JP, it’s a way that I have guided all the analysts and the institutional investors from the beginning and I think it will be important to what happens in the next several months as we meet with FDA. I mean the safety data iStent inject is just prolific and is now substantiated by several clinical studies. And so, I’m hopeful in deliberations, we may be able to move that to a one-year endpoint. It just remains to be seen. We will know in the next several months whether or not to do that. But I would say that two-year as your base and a one-year endpoint would definitely be a best case.

Perfect, thank you.

Welcome.

Your next question comes from John Block from Stifel. Your line is open.

Great. Thanks, guys. Good afternoon. I will keep it at two, Rich. The first one I think is for you, just gross margin trends. It seems like they did not get impacted too much on the manufacturing and efficiencies in 1Q 2017 and I would think any inefficiencies would dissipate in subsequent quarters and arguably you got sort of the price realization that becomes greater. So what do we think about going forward? I think gross margin is going higher from here, maybe any reason why we can’t get to the high-80s by the end of 2017?

Well, yeah, the only thing I would kind of throw in there is, I think, your observation is correct. I think the manufacturing efficiencies were largely limited to the fourth quarter. Although, I will tell you we did relocate one final production line from our old facility to our new facility during the first quarter, but I wouldn’t highlight that as creating any expectation of significant inefficiency. We probably didn’t see much of a margin improvement in Q1 just because we had that pressure on it offset perhaps somewhat by the price increase. But as we go forward you still have to take into account incoming competition, you have to take into account price changes and you have to take into account international mix. And we’ve commented before that in the markets internationally where we are direct, we see our ASPs as being about the same as they are in the U.S. before the price increase, so an increase in mix in international could have a slightly lowering effect on gross margin. I’d conservatively continue to guide investors to a mid-80s gross margin.

Okay, got it. Helpful. I appreciate it. And then the other one, just regarding sort of the dance volumes and price, did volume lead in the U.S. is well in terms of the revenue growth, I think in the press release and on the call, I believe maybe the commentary was specific to worldwide, but was that the case in the U.S. as well where volume lead overprice? Thanks, guys.

You are welcome. And simple answer, yes, same in the U.S.

Your next question comes from Chris Lewis from ROTH Capital Partners. You line is open.

Hey guys, good afternoon. Thanks for taking the questions.

Hi, Chris.

Wanted to start just on the pricing increase rollout specifically understand some customers don’t feel they should ever take a higher price for product. So for those accounts that have push back, can you just elaborate on what you’re seeing so far within those accounts and what strategies you’ve taken to help progress them as it relates to your pricing strategies?

Hi, Chris. It’s Chris Calcaterra. I think the key here is mostly education. What occurred the beginning of the year is unprecedented to get that type of increase in facility payment. And certainly there were some people that had a reaction to the price increase. Once you were able to walk in through the process and the fact that this was beneficial to all parties involved, certainly the customer Glaukos and the patient, and in turn we are also realizing some benefits from this price increase, it made it much easier for them to handle. Additionally, we offered some additional pricing programs, long term contracts to make it even more lucrative for them to conduct their business with Glaukos. So I’m not going to say that it went debt perfectly in all instances but overtime with education and the variety of options that we were able to present exceeded our expectations in terms of the execution of the program.

Okay, that’s very helpful. And Tom, maybe a question for you, iStent inject in combination with cataract surgery progressing down the regulatory path there. Given the improvements just in terms of procedural use of that product and potential improved IOP reduction just from the iStent product today, can you just talk about your expectations of how you think that product could and may accelerate adoption perhaps more so for that haven’t been performing MIGS today?

Yes, happy too. So I think everyone is well aware of the facility and just kind of the ease of implantation that can be garnered by the use of the iStent inject really is a prolific product. And so I’ll give you some examples where we’ve launched iStent inject in Germany and Australia, it has resonated highly with the physician community. They love the product, they love the ease in facility replacement, they love the predictability. And so to answer your question I think we can expect to see new surgeons that have been on the sideline get on board now. They may have been giving any number of objections into why they haven’t joined in the MIGS thus far but I think when iStent inject is available we’ll see many new surgeons who have been reluctant to join. I also think we will see a greater penetration within existing practices. This is clear to me as we see how the product has been utilized overseas that this will be more top of mind and there will be a greater utilization and I think a better capture of potential patients once that’s available. So I do think that we’re going to see some incremental gain and as I’ve talked about before we think there is enough headroom within the CPT code for us to establish a premium price which may also give us a little bit more ability to create robust growth with the new product line. For all those reasons, we remain very, very bullish on iStent inject and frankly we think it will be a tough, tough product to compete against.

Okay, congrats on the nice start to the year. Thanks.

Thank you, Chris.

Thanks, Chris.

Your last question comes from Joanne Wuensch from BMO Capital Markets. Your line is open.

Thank you for taking my question and congrats on the quarter. Can you talk a little bit about some of the direct consumer marketing initiatives that you were doing? Is that something honestly I haven’t seen them but not your target population, how are you approaching that?

Hi Joanne, this is Chris. We really are doing that through the physicians. We’ve selected a number of key markets where we have worked closely with iStent users to get on TV to have a one minute spot, two minute spot where they talk about the procedure to typically a conversation with the physician in one of their patients and then build awareness. Secondly, we have conducted a number of initiatives direct to consumer ads through Google search and things of this nature driving them to our website, the patients where they can find and select a physician within their local areas. And we monitor that all the time, we look at the metrics and we are pleased with the amount of activity that is generated through those initiatives.

Thank you. And then as my follow-up, to continue on the conversation you had regarding pulling surgeons and from the sidelines when you get the iStent inject, how many of the high volume cataract surgeons do you think you have today?

That’s not a number that we share with the outside community for competitive reasons. It is something that we do monitor and there are many that we still need to attract, and the iStent inject will help us to do that.

Thank you very much. Have a good day.

Thanks, Joanne.

There are no further questions at this time. I would now turn the call back to Mr. Burns.

Okay, I want to thank everybody for being on the call today and thanks for your continued support and your interest in Glaukos. For those of you who are finding to attend the ASCRS we look forward to seeing you in Los Angeles this coming weekend. Thanks and good-bye.

This concludes today’s conference call. You may now disconnect.