Glaukos Corporation (GKOS) Q4 2015 Earnings Report, Transcript and Summary

Sheree Aronson - Vice President, Investor Relations Thomas Burns - President and Chief Executive Officer Richard Harrison - Chief Financial Officer Chris Calcaterra - Chief Commercial Officer Analysts Michael Weinstein - JPMorgan Robert Hopkins - Bank of America Merrill Lynch David Roman - The Goldman Sachs Group, Inc. Brian Weinstein - William Blair & Company Caroline Corner - Cantor Fitzgerald Matthew O'Brien - Piper Jaffray

Welcome to Glaukos Corporation’s Fourth Quarter and Full-Year 2015 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] This call is being recorded and achieved, and an archived replay will be available online in the Investor section at www.glaukos.com. I’ll now turn the call over to Sheree Aronson, Vice President of Investor Relations.

Hello, everyone. Joining me today are President and CEO, Tom Burns; Chief Financial Officer, Rich Harrison; and Chief Commercial Officer, Chris Calcaterra. Following prepared remarks by Tom and Rich, all three gentlemen will take your questions. 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 planned objectives, strategies, and prospects, regarding among other things, our iStent product, our pipeline technology, 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 SEC filings for more information about these risk factors. You’ll find these documents in the Investor section of our website at www.glaukos.com. With that, I’ll turn the call over to President and CEO, Tom Burns. Tom?

Okay. Good afternoon, everybody, and thank you for being with us today. Our fourth quarter net sales were $20.3 million, up 44% versus the year-ago period. And this solid performance drove our full-year 2015 net sales to $71.7 million, representing a 57% growth versus 2014. And our 2015 gross margin rose to 82% from 75% in 2014. As we entered 2016, we began our full-year commercialization of our iStent Trabecular Micro-Bypass Stent, the ophthalmic markets first ever and flagship Micro-Invasive Glaucoma Surgery, or MIGS device. We’re in the early stages of forging an entirely new treatment class for glaucoma, and we’re pleased with progress to-date in terms of surgeon adoption and utilization, enduring clinical performance and the advancement of our comprehensive and unique MIGS product pipeline. So we’re building a firm foundation for sustained growth with performance that is tracking exactly to our game plan and to internal expectations. Consistent with this plan, we’re moving aggressively in 2016 to achieve four key objectives designed to extend our MIGS leadership in the 5.1 billion global glaucoma marketplace, and these include the following. First, leveraging our seasoned sales team and compelling clinical evidence to drive U.S. iStent adoption in combination with cataract surgery. Second, to fortify our leadership position and market expanding potential with next generation iStent flow devices for combination cataract and standalone procedures. Third, to advance our novel iDose injectable drug delivery platform designed to overcome the longstanding challenge of patient non-compliance with topical medications. And finally, to grow our global sales through targeted entry and/or expansion into high-value international markets. So let me speak briefly about each of these objectives beginning with the driving iStent U.S. iStent adoption. We had a number of new rep hires in 2015, while a few more reps maybe added in 2016. We’re confident that we currently have the optimal scale and coverage to effectively reach our target universe of roughly 5,500 ophthalmic surgeons. In the fourth quarter, the average number of U.S. Glaukos sales representative was 49, an increase of 20%, 26% over the same year-ago period. Remember that this figure excludes additional field sales person – personnel such as sales managers, reimbursement specialists, and clinical relations managers. A primary focus for the U.S. sales team is to train new surgeons on the iStent procedure and increase utilization rates and practice with fully trained iStent surgeons. So at the end of 2015, the team had trained more than 1,600 U.S. surgeons, representing an increase of more than 40% versus year-end 2014. And we expect even greater rate of growth in the number of iStent trained surgeons for 2016 with a heightened focus on higher volume cataract practices. With iStents three-year track record of successful commercialization, these high-volume cataract surgeons are increasingly ready to complete training and to begin incorporating iStent into their treatment plans. To engage and inform the target surgeons, we’re initiating a number of investments in 2016 that are designed to build over time and continually reinforce our market position as the MIGS pioneer and enduring leader. These include introduction of a new iStent professional marketing campaign, a stepped-up presence that major ophthalmic scientific meetings, new web-based marketing assets and initiatives and iStent educational outreach programs to target optometrists, a primary patient referral source for cataract surgeons. In addition, we’re inaugurating a MIGS fellowship course to arm glaucoma fellows with the knowledge, surgical techniques, and skills necessary to provide MIGS solutions to patients in the future. This program will include doctor led didactic sessions, video presentations, and hands-on wet lab training. Our 2016 plans also include highly targeted patient awareness DTC programs, designed to connect prospective patients with iStent surgeons and help practice staffs explain iStents benefits to patients and their families. The cornerstone of glaucoma therapy is providing treatment that maximizes clinical benefit, while minimizing risk. Our commercial success is and will continue to be rooted in iStents excellent clinical results in highly favorable safety profile. We’re beginning to use all avenues available to communicate this validating performance data to the glaucoma marketplace, especially compelling is the emerging body of real-world data that demonstrate the enduring IOP lowering power of iStent. For example, in a study conducted in Germany by Dr. Tobias Neuhann and just published in the Journal of Cataract and Refractive Surgery 39 patients receiving iStent with concomitant cataract surgery achieved mean IOP below 15 millimeters through three years postoperative results. This represents a 36% reduction at 36 months in mean IOP from medicated baseline IOP. And at 36 months, patients also achieved an 86% reduction in the mean number of topical medications used. Another interventional case series study of 19 subjects published in the British Journal of Ophthalmology by Dr. Arriola-Villalobos further underscores iStent’s long-term performance. Study subjects receiving iStent in combination with cataract surgery achieved mean IOP of 16.1 mmHg at five years postoperatively, with 42% of subjects requiring no hypotensive medication by the end of the follow-up period. And in the study like Dr. Katz published in the December issue of Clinical Ophthalmology, 119 glaucoma subjects received either one, two, or three iStents in the standalone procedure. At 12 months postoperatively, 65% of the one-stent cohort achieved mean un-medicated IOP less than 15 mmHg. That was roughly a 40% drop from the mean preoperative un-medicated IOP, in a particular note is a fact that, IOP reduction in these patients was accomplished without a concomitant cataract procedure showing that the efficacy of iStent is significant and separate from the IOP reduction typically associated with the surgical procedure to remove a patient’s natural lens. So on all these studies, the safety profile of the iStent continues to confirm and highlight the extraordinary benefit to risk profile that the implant offers ophthalmic sturgeons and patients worldwide. So importantly, these favorable trends and improved iStent protocol outcomes since our 2018 – 2008 IDE pivotal trial, submission suggest that as surgeons become more proficient iStent implanters, their procedural efficacy shows continued and marked improvement. These results confirm iStent’s efficacy and very favorable safety profile establishing it as a benefit to risk MIGS leader and a surgeons go to MIGS first line solution well into the future. So later this week, we head to the American Glaucoma Society Annual Meeting in Fort Lauderdale, where our current and pipeline iStent technologies will be featured in numerous posters and presentations. And data that presented include outcomes from various studies, evaluating the performance of one or multiple Trabecular Micro-Bypass Stents in combined cataract surgery or in standalone procedures, as well as Trabecular Micro-Bypass and Suprachoroidal stents used in combination in refractory or advanced glaucoma patients. The broad array of studies illustrate the robust market expanding potential of the iStent platform we are creating with our pipeline of late-stage technologies designed for use serially or in combination. Our goal is to provide clinicians a full complement of titratable and combinatorial treatment approaches they can use to achieve the highest efficacy with minimal patient risk. So, for example, Dr. Rick Louis will present data at this meeting from an international iStent Inject Study showing that 57 subjects undergoing standalone procedures achieved mean un-medicated IOP of 14.4 mmHg at 18 months postoperatively, down approximately 40% for a Mean un-medicated baseline IOP. Like the flagship iStent, our next-generation iStent Inject is designed to restore the natural physiologic outflow of fluid through the trabecular meshwork into Schlemm’s canal. However, the iStent Inject is preloaded with two micro-scale stents that the surgeon places via a click and release motion into multiple trabecular meshwork locations, further enhancing the IOP reduction potential of the product. We’re conducting – we’re currently conducting U.S. IDE clinical trials to evaluate the safety and efficacy of two versions of the iStent Inject. We expect each version to deliver potent competitive advantages to Glaukos. The first is being evaluated in a pivotal trial comparing iStent Inject in combination with cataract surgery versus cataract surgery alone. With enrollment completed in mid-2015, we’re now in the midst of a two year follow-up period. And we believe it’s IOP lowering capability, favorable safety profile, and improved ease-of-use will appeal to a broad spectrum of comprehensive ophthalmic surgeon and fueled new growth for Glaukos. The second iStent Inject is an injectable version, capable of making its own self-sealing needle penetration for uses as standalone procedure and eyes not undergoing concurrent cataract surgery. Enrollment continues in the initial clinical trial, which compares iStent Inject to a SLT laser procedure. This product has the potential to substantially expand our addressable market by offering a viable MIGS solution to as many as 3.5 million U.S. open-angle glaucoma patients, where they don’t need or have – already had cataract surgery. We believe, we are the only company currently seeking FDA approval for the standalone indication or an injectable MIGS solution. So our pipeline also includes the iStent Supra, which is 4 millimeters long, curved to follow the ocular anatomy, and designed to access the secondary fluid outflow of pathway in the suprachoroidal space. Enrolment continues in our U.S. IDE pivotal trial. We’re pleased with the results from an international iStent Super studies, which shows its ability to significantly lower IOP in a straightforward procedure. We also know based on published literature that there are higher risks associated with devices placed in the vascular suprachoroidal space. The quality include Intraocular pressure spikes, transient, hypotony, hyphema the need for secondary surgical procedures, and stent occlusion among others. In light of this, we believe the suprachoroidal MIGS devices are best deployed as enhancements to trabecular meshwork stents in patients with more progressive glaucoma. More podium presentations are professing the benefits of this approach. For example, the latest data from an ongoing study, which is being presented at AGS later this week by Dr. Jonathan Myers will show that refractory open-angle glaucoma patients who received two iStents and iStent Supra and a single postoperative medication topical travoprost achieved mean IOPs of 13.7 millimeters through three years postoperatively, as well as reduced pretreatment drug burden. So turning now to iDose. We accomplished a major pipeline milestone in early 2016 with news that the FDA has allowed us Phase 2 trial on the iDose Travoprost Intraocular Implant plan to move forward. And we believe our team deserves considerable credit for submitting the thorough IND application that generated no significant follow-up questions or delays from the agency and has put us well ahead of our initial timeline. Since receiving this news, we’ve worked swiftly to identify investigators and put the necessary pieces in place to initiate this Phase II clinical trial. We expect enrolment to commence very soon. Injected to a corneal incision and secured in the anterior chamber, the iDose is a micro-scale implant that is designed to elute therapeutic levels of a special formulation of travoprost from within the eye for an extended periods of time. When depleted, the iDose can be removed and replaced in a subsequent procedure. We believe iDose, if approved has the potential to dramatically change the glaucoma treatment paradigm, because it offers an alternative to chronic daily prescription eye drop treatments, which are subject to high rates of noncompliance, carry troubling side effects, and may cause long-term ocular surface damage. Initial iDose clinical results are very promising. In an early international study, 69 patients were randomized in three cohorts. The first two cohorts received iDose with one of two different elution rates and the third cohort received topical travoprost. At 12 months, both iDose cohorts achieved mean IOP levels below the topical travoprost cohort. The iDose platform is integral to our strategy to transform glaucoma treatment. And we expect surgeons to use it alone, whereas customized combinatorial therapy with iStent flow devices to manage target pressures based on each patient’s individual disease state and progression all the way from naive glaucoma to refractory glaucoma. So touching briefly on our progress outside the United States, we have announced in recent weeks the establishment of a direct sales organizations in Canada and Australia, along with the commercial launch of the iStent Inject in both of these markets. In addition, we’re very pleased with the first full-year performance of our direct sales organization in Germany, which began operations and launched iStent Inject in mid-2014. We’re also in active dialogue with Japan regulatory authorities and are awaiting word regarding approval of iStent in combination with cataract surgery. And we’re excited about the potential of this opportunity, where roughly 3 million patients are estimated to have glaucoma and approximately 1.5 cataract procedures are performed annually. We have already created a direct sales organization for Japan that’s fully trained and ready to watch iStent one approval comes. So overall, we remain highly targeted and disciplined in our approach to international expansion. Our products are now approved in 27 countries, most of which are served through partnerships with ophthalmic distributors. And we’ll continue to evaluate possible conversion to direct selling models in select countries where favorable reimbursement and market dynamics exist, or that we can create. With that, I’ll pass the call to Rich for a summary of our fourth quarter and of our full-year financial performance. Rich?

Thanks, Tom. Good afternoon, everybody. As Tom said at the top of the call, fourth quarter net sales rose 44% to $20.3 million versus $14.1 million in the same quarter a year ago. This post year end enclosing amount was about $200,000 higher than the Q4 net sales estimate we provided in our January preannouncement. U.S. sales were responsible for 99% of the year-over-year increase and represented 95% of total sales in the quarter. For the year, we finished 2015 with net sales of $71.7 million, representing a 57% increase over 2014, again, about $200,000 higher than our mid-January preannouncement of $71.5 million. For the year, U.S. sales were responsible for 95% of the increase and represented 94% of total sales for the year. In both the fourth quarter and the full-year increased unit volume worldwide was primarily responsible for the increase in net sales, as we grew our surging customer base and increased overall iStent utilization. Turning now to the gross margin for the fourth quarter of 2015, our gross margin was 82% of sales versus 65% of sales in the same period of 2014. The 2014 period included a $2.6 million charge associated with an agreement with the Regents of the University of California, and it the have the effect of reducing our Q4 2014 gross margin by approximately 18 percentage points. For the full-year 2015, our gross margin was 82% of sales also versus 75% of sales in 2014, which increase reflects the same $2.6 million charge we incurred in 2014. Turning now to operating expenses. In the fourth quarter of 2015, SG&A expenses rose 39% versus the fourth quarter of 2014, and the increase was 56% for the full-year 2015 versus 2014. These increases reflect primarily higher personnel, travel, and other costs related to our ongoing efforts to build a global infrastructure and sales organization that can continue to drive and support our growth. Keep in mind that as we transition from distributor models to direct sales models in certain international territories, we will see the benefit of reporting revenues at end-user pricing in these markets rather than the discounted distributable pricing will also be incurring the operating expenses attributable to the subsidiary. In the fourth quarter of 2015, R&D expenses rose 19% versus the fourth quarter of 2014, and the increase was 30% for the full-year 2015 over 2014. The rise primarily reflects the cost of additional clinical affairs personnel required to manage the increased number of clinical studies and the associated investigational sites and study investigators. Our operating loss in the fourth quarter of 2015 dropped to $2 million, compared to a $5 million operating loss in the fourth quarter of 2014. For full-year 2015, the operating loss was $10.3 million, down from $13.2 million in 2014. These improvements show that the benefits of our sales growth and our gross margin enhancement exceed our growth and operating expenses. We finished the fourth quarter of 2015 with a net loss attributable to common shareholders of $2.3 million, or $0.07 per diluted share, compared to $4.6 million, or $1.94 per diluted share in the fourth quarter of 2014. This reduction in per share loss primarily reflects the increase in weighted average shares that resulted from the completion of our IPO in June 2015. For full-year 2015, our net loss attributable to common shareholders was $37.2 million, or $2.13 per diluted share versus $12.1 million, or $5.29 per diluted share in 2014. In arriving at the reduced diluted loss per share for 2015, the effect of the higher total net loss that resulted from the recording of $25.7 million charge associated with the deconsolidation of those medical was more than offset by the increase in weighted average shares resulting from completion of our IPO in June, and thus we saw the reduction in the diluted loss per share. On the balance sheet, at the end of 2015, our combined cash, cash equivalents, and short-term investments stood at $91.1 million compared to $2.3 million at year-end 2014. This provides a solid financial foundation for execution of our global growth plans as we move forward. And as we announced in January, we expect our 2016 net sales to be in the range of $90 million to $93 million, representing growth over 2015 net sales in the range of 26% to 30%. And we would like to reiterate, we expect 2016 net sales to reflect seasonality patterns generally consistent with U.S. cataract procedure volumes, which are typically softer in the first quarter and stronger in the fourth quarter of a given year. We’re extremely pleased with the sales growth we achieved in 2015, and the growth we expect in 2016, which closely aligns with our pre-IPO models. Now, I’d like to turn the call back to Tom.

Okay. Thank you, Rich. And so I’m just going to recap. We’re pleased with the 2015 results and we’re confident in our ability to meet or exceed our 2016 goals. Our global growth strategy is right on track and moving ahead as planned. Our U.S. sales team is largely in place and fully focused on training new surgeons while driving continued iStent adoptions. To augment their efforts, we’re rolling out in a array of programs to acquaint, inform, and educate physicians and patients on the benefits of our glaucoma solutions. Our international presence continues to expand as we enter new markets with discipline and focus and a growing body of clinical evidence makes clear that a single iStent and delivered sustained IOP reduction and the procedure that provides, we believe is an optimal risk to reward profile for patients and doctors and puts Glaukos in a strong, enduring, competitive position. To extend and broaden our leadership over the long-term, we are developing an unrivaled pipeline of true micro-scale and injectable flow and drug delivery implants to advanced patient care and to transform glaucoma therapy. And so with that, I’ll open it up to questions. Operator?

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

Good afternoon, guys. And first off, can you hear me okay? I apologize for calling in from mobile…

Yes, we can hear you. Thanks, Mike.

Okay. So, Tom, there was a lot that you covered in your remarks that I thought was interesting and new. Let me just try and get to a few of them here. So one of the things that I thought was very interesting was if you talked about your training for 2016 and you improved the number of trained surgeons 40%, 2015, can you talk about growing that potentially at even higher rate 2016 to expand upon that?

Sure, kind of, I’m going to turn to Chris for this one, Mike.

Hey, Mike, it’s Chris, how are you?

Hi, Chris, very good.

Good. So, yes, we did increase the number of trained surgeons by 40%. It’s something that we track and we’re looking to continue to do that or exceed that number. We train about three surgeons per quarter per Representative. But we’re looking to increase that while at the same time making sure that we still have the quality training program that we’ve been so proud of in the past few years.

Okay. And can you just – let’s reconcile if we look at the 40% growth in your surgeon base and training surgeons in 2015 with the 57% revenue growth for the year. Just help us reconcile that, obviously, you’re getting greater equal penetration into accounts for training more surgeons, your 2016 outlook calls for very high rate of growth in trained surgeons. But you revenue guidance is a bit more conservative. So maybe just want to spend a minute reconciling that for people?

Yes, we feel good about our revenue growth for 2016 at the 26% to 30% growth rate. We still feel that this is a very successful loss of a new category device, where we still have opportunity with adding additional surgeons, as well as going deeper with into accounts, and these guys will be focused on doing both of those. I would also add that, since we’ve added roughly about 10 reps towards the second-half of the year, those guys are getting up to speed and not be able to bring in additional doctors and be able to bring in additional penetration within those existing accounts.

Chris, I was also very interested in some of what Tom was talking about in terms of the marketing plans for 2016. And you talked about a new iStent pressure on marketing campaign by stepping up the presence some of the major meetings, a web-based marketing initiative? Could you just spend a few more minutes on that, just kind of walking us through what’s new? What you guys will be doing in 2016, which you haven’t done before?

Yes, I’m glad you asked that question, Mike. We have a lot of activity in all of those areas. I expect to introduce a new patient base campaign within the next couple months, as well as a professional marketing campaign. In terms of education, we have a mid-course that we’re doing in conjunction with ASCRS in May. We’re also hosting our first ever fellowship program in the April timeframe, where doctors Samuelson and Lousi will be the Co-Directors of that program. We’ve invited every glaucoma fellow out there to come out to California over a two-day periods of time to learn more about MIGS. We stepped up our efforts with the optometrist. As you know that community – the OD community is responsible for many of the referral patterns into – of the ophthalmologists. And another example of our scientific presence at these meetings would be the AGS, which Tom and I leave for tomorrow, where we have eight posters and we’re stepping up efforts in all different categories. So it’s a full coordinated commercial plan to continue to increase the overall knowledge and acceptance of our iStent in the MIGS category.

Perfect. And then Tom, I wanted to take the opportunity just ask you about Alcon’s acquisition of Transcend. We would seen the headline data from the efficacy side we haven’t seen the safety on Transcend. I thought the efficacy data was, at least, from their standpoint a bit disappointing. I thought it might be better than what showed up, and we haven’t seen the safety side which is really the question. So could you just talk about how you think the Transcend products fits into the glaucoma treatment paradigm assuming it actually gets approved from the U.S.?

Yes, be happy to address it. First of all, we see Alcon entering the marketplace as how could we not as a full validation of the category that we’ve created over the last decade plus. By coming into the market, we think that they will, with the resources, they’ll be able to help us drive and generate MIGS even more thoroughly into everyday practice. An so, we consider it a validation of the efforts of that we’ve been pursing over the past decade plus. Now, with regards to the data as we understand it, that’s been submitted in abstract form. I think we look at it, and we gain a quiet confidence, once we review and understand it. So in that data set and again it’s important to understand what’s really different about the clinical trials that we conducted our initial PMA trial in the past versus the trial they conducted. And the two principal differences are that one, we were powered for one year and not two year with a total of 240 patients versus over 500 in their clinical trial. And more importantly, we did not have a terminal washout. So when you think about it, any attempt to compare those studies based upon the look at the proportional analysis in the primary efficacy and secondary efficacy endpoints, we’d be really entirely misleading. As we look at it, the only principle area of comparison and again, I hesitate to do it, because we’ve already moved the clinical biomarkers substantially as you can see from the Neuhann data and from the Katz data, as people gain facility with the use of the iStent. But even so, if you look at the point of comparison with the side pass clinical trial, you will see that in one year, iStent plus cataract surgery reduced IOP 33.1% from a mean IOP or un-medicated baseline of 25.4% to 17% with a Mean of two meds. And the side pass plus cataract surgery reduced 31.7%, from an un-medicated baseline of 24.4%, which equates to 16.7 mmHg at 12 months mean of the same point two medications. And so at best, you would say that data may be comparable. And as I’ve explained before to the analysts and to the community, our initial trial was done with 29 investigators, 70% of which did five or less cases, so we’re delighted with the data that we see. And even more so we’re delighted with data that we’re generating data-to-day the Neuhann data, which shows a 14.9 millimeter mean un-medicated base or largely un-medicated baseline. At three years, the Katz data would show 65% of patients at or below 15 millimeters at 18 months with a single stent un-confounded by cataract surgery. And then Mike, as we’ve talked about before the cluster of retrospective data that we are seeing from registry data, where we look at 160 patients from five different surgeons in using a single iStent in combination with cataract surgery that reduced pressures from 18.5 millimeters on a pre-medicated base line, down the 14.5 millimeters with a significant reduction in drug burden. So when I see all that I become more sanguine, I become more confident, I like our position. But most importantly, I think, we offer the highest benefit risk ratio of any potential MIGS device in the market. So you mentioned that safety, we haven’t seen the data yet. And we’re unlikely to see the data at the ASCRS as well. I think when we’ll see safety data, they’re typically at the panel meeting. And that’s when you required to kind of show exactly what happened in the clinical trial. And I think when we see that the analyst and the community will be further convinced as I’m that the iStent will become really be validated as first line therapy and an enduring competitive presence for many years ahead.

So just to follow that up. So you don’t think they’re going to show their safety data and they get zero?

I think they will. But I think it will be more topical, and I think it will be a summary form. I think what happens Mike and it’s been our experience as well, when you get to panel, that’s when they really dig deep, and that’s when you’ll see the full extent of adverse events and any potential assays.

Understood. I’ll let some others jump in. Thank you, guys.

Thanks, Mike.

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

Thanks. And good afternoon and thanks for taking the question. So just a follow-up on Mike’s question there just on Transcend and Alcon. Are you – when you guys provide this 2016 guidance, or are you assuming that they – that you have a competitor on the marketplace in 2016, or do you think it’s going to take them after they get approval may be another 9, 12 months to get reimbursement and that it’s really more like a late 2017 kind of competitive situation?

Yes. So what I would say to that Bob is, the short answer is no. We don’t believe, we don’t assume that we’ll see a competitive entry from an Alcon bypass by year end. I think as I have said before my expectation would be somewhere in the first-half of 2017. I think it would be based on history and precedent and closely following FDA’s items over the years. That would seem to me to be the most reliable estimate of one or two to the market. But you raised a good point, I mean, when they do enter the marketplace, one of the things that we did establish was a separate code – we Glaukos established a separate code 0253 T for suprachoroidal stents. And we did so that in the future when surgeons chose to use the Trabecular Bypass in combination with suprachoroidal stents, they would have two codes, resonant codes to be able to click. So they will get a 100% of the first procedure in by the Medicare reduction rule of 50% of the second procedure. And by doing so we thought we would be driving the best and most ethnical therapy with an incentive that will reward the surgeon for placing both these devices in more progressive patients. But one of the issues associated with that is that by creating that new code a competitor will have to use that code when they enter.So I think you are exactly right. Any new competitors going to have to start from scratch, they’re going to have to go to max, they’re going to have to present this data, they’re going to have to go through kind of a heavy sledding that we went through. And we did it, I think in record time. We got full Medicare MAC approval within seven months after commercial launch. And I think that’s a tough bar to hit. And I think any competitor that enters with a new code is going to have several months going through petitioning and denial of claims, which actually becomes a frustrating source for physicians who in the event that they want to try the product will go through some onerous trials before they actually get full approval.

So, thanks for that. And then just as a follow-up, can you remind us of your latest thoughts on timing for iStent Inject? So you mentioned just in your prepared remarks that the trial finished enrolling in mid-2015. Will we see any data at the one-year timeframe, and will we have to – or will we have to wait for two? And kind of what’s your latest view also on a best case timeline for a regulatory filing? Is there is scenario where that could be made after one year? Thank you.

Yes. So I think Bob the short answer is, we don’t expect to issue or disclose any data, and so we have completed the two-year data set of safety and efficacy. So to address your question further and this is the question that I might have answered previously, but there are several trade-offs to consider. And as you know, the MIGS guidance – new MIGS guidance from the FDA basically states that if a solicitor or sponsor can establish in a variably or not only weighed benefit to risk scenario for a new product that meets the safety and efficacy parameters in the patient’s advantage that they will consider one year efficacy endpoint. And as we look at that, there are several trade-offs to consider. First, even if we were to agree or get the FDA to agree to a one-year end point, we would worry a little bit about how the FDA would move pursuant to that one-year end point. Would they wait for two years to see that data before they adjudicated on the case series and gave us the approval to move forward. So I’m entirely convinced that it’s a one-to-one ratio with seeking a one year endpoint. Also as you’re well aware going to one year endpoint in changing our statistical plan could impose some significant burdens on us. So we’re highly sensitive to that. And then finally, we weigh the advantages of having two year data. What that means? Competitively what that means, foundationally for the future, what that means for payers, and we have a bias about that two year data is data set that we would like and we would move forward with. And so having said that as you look at your models, I guess I would reaffirm that we stay with the base case of two years, as you speak and look chronologically and when we would get approval for iStent Inject, and if there is any change in our thinking, we will alert you to that.

And then lastly, what’s the next major timeline for any kind of data from iDose? Just when the next major data set that we should look forward to? Thank you.

Yes, I’m Chris. That’s a great question thanks Bob. So we are entirely pleased, we – as you mentioned and others have given us credit, we have our S-1 that we would file for our IND in 2016 and instead we were fully cleared, we had filed in late 2015 and we are fully cleared to move forward early in 2016. So we are humping, and moving forward with all speed to enroll clinical sites and to fully enroll this initial Phase 2 trial, we believe once we enroll that and we will be able to unmask the data once we have the last patient enrolled at 12 weeks, and then we will be able to disclose our findings to the community of which, we are principally excited. So I won’t give you any direction or give any estimates on when we think we will have the data, but chronologically you can estimate based on the information I’ve given you.

Perfect, thank you.

Thanks, Bob.

Your next question comes from the line of David Roman from Goldman Sachs. Your line is open.

Hello, David?

Dave are you ready, your line is open, you may have your cell phone mute.

Can you guys hear me okay now? Sorry about that.

Yes, thanks David.

Thanks for taking the questions. I wanted just to start with the progression of sales that you mentioned, in both the press release and the prepared remarks, recognizing the seasonality that comes with the cataract surgery market. It does look like your guidance would imply a fairly significant ramp throughout the year, and an acceleration in overall procedure volume growth, as we pace through 2016. Is that, I guess A, an accurate interpretation of what you’re saying with respect to the quarterly phasing? And then B, is there anything that would specifically drive an up-tick throughout the year, whether it’s some of the efforts that you are undertaking, with respect to market development, patient education, et cetera?

So David, answer to your question directly, yes that we will suggest that we have a significant up-tick in sales beyond the first quarter. And yes to your second question, all the initiatives that we have in place from the new professional campaigns, via patient campaigns, or the OD networking to the programs that we are putting in place, the Congress and so forth would also help to stimulate that growth and from the second quarter on through fourth.

Okay. That’s helpful. And then, maybe just going into the outlook. Assuming – taking Tom’s comments about not expecting a competitor until the first-half of 2017, it looks like you are assuming pretty much a consistent rate of market development, in terms of penetration, for 2016. Is it reasonable to think that some of the efforts you’re undertaking actually would be a source of upside, relative to those expectations that you’re putting out today?

Well, I – we stand by our numbers, but we always look to achieve or exceed those numbers. And we are quite pleased with our progression with what we’ve done in the past and where we are today.

And then lastly – I know you are not giving specific guidance around the P&L, but can you maybe help us think about some of the spending that would be associated with additional marketing? You’ve done a really solid job keeping a lid on discretionary expenses thus far, post IPO, and getting very close to breakeven in the fourth quarter. How should we think about the investments that you may be undertaking in 2016?

Yes, David this is Rich. Good question and I think we would expect to continue to see our spending in the operating expense area both in SG&A as well as R&D continued to increase. As Chris mentioned, all the programs that he discussed all have a cost associated with them. I mentioned in my kind of prepared remarks that we’re going to start to incur the expenses that are subsidiaries more fully now. we had limited exposure to those costs in Q4. But going forward this year, we’ll have a full exposure to new spending at our Canadian, Australian subsidiaries in addition to the expenses we had late last year from Japan and all of last year for Germany. And then on the R&D side, we are going to be spending more money on the iDose clinical study. So we’re going to see increases in spending there. So there’s really no change in our outlook on when we expect to get to break-even or profitability.

Okay. Thank you very much.

Thanks, David.

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

Hey, guys, thanks for taking the question.

All right, Brian.

So a lot of things you’ve already been asked, but let’s talk a little bit about OUS. You guys are direct Canada and Australia and you are seeing some uptick in Germany. But can you talk a little bit about what you expect OUS next year, and sort of break-down the growth rates that you’re expecting for the overall business between the US and OUS? And inherently in that, can you talk about what’s kind of embedded as far as your Japanese assumptions, as far as revenue contribution potentially from that country?

Hey, Brian this is Rich, I’ll comment and then Chris may want to add some color afterwards. But we’ve – we’re expecting approval for Japan in 2016, but we haven’t really indicated when. So we are expecting as soon as we get that approval, we’ll start to contribute. But certainly the Australia and Canada are often running and we expect them to do well this year. But overall our guidance on international has been – our history has been – a 5% of our revenues have been OUS. We think that in the relatively short-term, we can start to get it closer to the 10% range. But at this time until we see exactly how everything works out in those market that I think we would be hesitant to say much more than that. And so I’d say plan on somewhere between 5% and 10% of our sales in 2016 being from international.

Hey, Brian, how you’re doing? It’s Chris.

Hey, Chris.

Hey, and I would say that we’re really stepping up our efforts here. We’re going to be in four markets directly; Germany, Canada, Australia and Japan; once Japan gets approval. But all these programs that we’re putting in place, many of them carry over outside of the United States as well. Specifically, our initiatives around clinical programs, our professional campaigns, and many of our marketing initiatives will also help to drive sales outside of the United States and we have an increased focus with our distributor alliances as well.

Okay. Thanks for that. Going back to a question that was asked before and maybe I missed your answer to it. But specifically, can you comment on how the enrollment is going for gen 3, and kind of when enrollment you – when do you expect enrollment to be completed for that, as well as for the Supra?

Okay, Brian, this is Tom. So gen 3 is the Supra, so let me deal with that first. And we are in expanded phase clinical trial. We are making good progress. As in the past, we hesitate to give any further guidance on when we expect to achieve approval. But I will tell you that we’re well in to the expanded phase and we are recruiting at a rate that it meets or exceeds our internal expectations.

Right. And obviously, I meant with the Supra, of course, but then also with the second version of Inject. And any specifics specifically about when the enrollment would be completed there? But I’m guessing…?

Yes, I’ll take that, no question. So I’ll take that as well. So as you know, we received approval for the inject Phakic and Pseudophakic trial really late in 2014 and began enrolling in earnest in 2015. And as I stated before, when you pioneer our new clinical trial, the FDA imposes some really or can impose in this case did impose some pretty narrow inclusion exclusion criteria. So we are moving through and we’re starting to work with the FDA to file amendments, and we made some substantial progress in broadening the clinical enrollment and the criteria for the Phakic and Pseudophakic trial. We have more to go. And we did this and overcame these obstacles in our first clinical trial with combo cataract. We’ll do it here. I won’t give you guidance on when we’ll finish the Phase 1. But I can assure you once we do, we’ll be moving forward in an expedited fashion into the Phase 3 trial and toward a commercial approval.

Okay, great. Thanks.

Thanks, Brian.

Your next question comes from the line of Caroline Corner from Cantor Fitzgerald. Your line is open.

Hi, guys, thanks for taking my question and congratulations on the quarter. Most of my questions have been answered at this point. But just pushing a little bit, as we look at the international markets, I heard your commentary about how you do about 5% internationally growing that to 10% in future years? As you approach these markets; Germany, Australia, Japan and Canada, some of the competitors or potential competitors have products that are either CE market, or cleared by Health Canada, for example. How are you positioning your iStent any differently in those markets, as you start your initial marketing campaigns and push in there? Is there specific data you are using more readily, when you are selling the product in those markets, or is it just more of the same?

Hey, Caroline, this is Chris. And it’s to use your terminology it’s more of the same. And while our competitors may have CE marking approval with Health Canada, very few of them are actually selling product internationally. So we continue to utilize the same direction, the same positioning, the same approach that we do here in the United States, and we’ll continue to do that even as competition comes out and is selling those products abroad.

Okay. And you are anticipating, as you get out there then in those markets and seed the market that competitors might piggyback on your efforts, as far as bringing MIGS to the forefront and getting the word out, and having patients in those geographies accept MIGS as a next big new thing?

Yes, I think when you have a company such as Alcon and Allergan getting into the MIGS space, their promotional dollars, their selling efforts will continue to expand the market. We won’t be the only ones out there really talking about it not the Transcend or AqueSys or Ivantis haven’t been speaking about. But when you have the support of the companies as large as Allergan or Alcon, I think that helps to extend the market and validates the space.

Okay, thanks. And then just a quick one too. You were talking about the second-generation Inject enrollment, which has been enrolling in 2015. You mentioned that the FDA had put some pretty specific inclusion and exclusion criteria in place, which helps temper enrollments to some degree. Can you talk a little bit specifics as to what they are, or have you given that before?

Caroline, hi, this is Tom. Yes, I would be hesitant to do so for competitive reasons, right? We worked very hard to establish this clinical protocol with the FDA, as a landmark first ever Pseudophakic trial for MIGS device. And as much as I like to help people and competitors when I can, this is probably not an area that I would be inclined to do so.

Okay, thanks. I was just checking, I hadn’t missed anything there. Thanks very much, and congratulations on the progress.

Thanks, Caroline.

Thank you.

Your last question comes from the line of Matthew O’Brien from Piper Jaffray. Your line is open. Matthew O’Brien: Good afternoon. Thanks for taking the questions. Just a follow-up on the last couple of questions on the enrollment. Tom, am I reading this the right way, that this is clearly – the timing of that could be delayed slightly?

Yes. Well, so Matt first of all, nice to hear from you. What I would say is that, delay is not the word I would use with the guidance that we’ve given with this clinical trial what they consider they [indiscernible] that we would expect to commercialize this within the five-year planning period. We gave that guidance during the IPO and during the tale end of 2015. And so we expect that we are maybe this was not an unanticipated period where we negotiate with the FDA and look to be able to expand the inclusion/exclusion criteria. We’ve done it before with our initial clinical trials. So now I would not characterize it as a delay. It meets our expectation and we’ll continue to make progress with the trial. Matthew O’Brien: Okay. So you’d built in some flexibility and you may need some of that here?

Yes. That’s correct. Matthew O’Brien: Okay. And then just heading back to Q4 for a second, I understand the 2016 guidance seems fine. But the sequential improvements that you saw in revenue in Q4 was the same that you saw in Q3, and well below what happened in Q2. And I know Q4 is typically a seasonally strong period for you. So I’m just a little curious as to why, I know your results are in line with expectations But why results weren’t even a little bit better on a sequential basis there in Q4?

Yes. Hi, Matt, it’s Rich. We are always – we’re going to always going to have some variability from quarter-to-quarter, and we’ve mentioned seasonality is kind of an underpinning that may show up a lot and in some cases may not. So versus some of the analysts expectations, we did extremely well in Q3. We tempered the expectations, I think when we gave our guidance for Q4, and our numbers came in where we expected them to be. Matthew O’Brien: Fair enough. And last one for me just and I know this is a ways away. But one of the things that I think some investors are a little bit worried about is just the reimbursement transition that you are going to be going through here in 2017 from a temporary code to a permanent code. And I’m just – and I know you’ve talked about it in the past. You’re anticipating it will be similar rates, but I’m just curious, what gives you that confidence in seeing a similar type rate once the permanent code comes out? And when is it – even if the payment comes down to Trabeculectomy levels, or even a slight discount to that, would that really impact utilization of your iStent?

Yes, Matt, I’ll take this. So what we said is that, as you know that category three code that we currently have in place will sunset at end of 2017 and we have the opportunity at that time to petition for category one code, or to try to seeking another extension. So we’ll continue to consider as we go forward. In converting to a category one, which gives us some confidence is, one, I can tell you we’ve done our own RVU probing within physicians that have utilized iStent, which gives us a point to understand where we may end up, and an RVU analysis, which is typically done by the Rock committee as you convert to a category one, that data is resident with us and gives us implied confidence. But secondly, one of the things we look at as kind of a low watermark is the goniotomy procedure. And if you look at the that that is again goniotomy, which is typically used in peds, a radial incision made in the trabecular meshwork, this is paying at current rates at around $700. And I think you could make an argument that the iStent is, at least, goniotomy plus and should fall somewhere above the RVU analysis for what goniotomy currently is at. Now having said that as we go forth in the future many years, there will be pressure, there has to be. As we become more ubiquitously years and if we become, as we demonstrate the kind of penetration globally that we think we will, I think that there will be some change in rates – the Medicare rates that physicians get for implanting the iStent. But I think those would have to be really substantially below what our estimates are to affect adoption. And so we remain confident that reimbursement will serve us during the planning period and beyond. Matthew O’Brien: Very helpful. Thank you.

Okay. So with that I want to thank everyone for joining us today and really thank you for your continued interest in Glaukos. Thanks very much and good bye.

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