Glaukos Corporation (GKOS) Q2 2018 Earnings Report, Transcript and Summary

Welcome to Glaukos Corporation's Second Quarter 2018 Financial Results Conference Call. A copy of the company's press release issued after the market closed today is available at www.glaukos.com. [Operator Instructions]. This call is being recorded, and an archived replay will be available online in the Investor Relations section at www.glaukos.com. I will now turn the call over to Chris Lewis, Director of Investor Relations and Corporate Strategy & Development.

Hello everyone. Joining me today are Glaukos President and CEO, Tom Burns; CFO, Joe Gilliam; and COO, Chris Calcaterra. Following our prepared remarks, we will open the call to questions. [Operator Instructions]. Please note that all statements, other than statements of historical facts, made on this call that address activities, events or developments we expect, believe or anticipate will or may occur in the future are forward-looking statements. These statements include statements about our plans, objectives, strategies and prospects regarding among other things, our products, our pipeline technologies, our U.S. and international commercialization efforts, the efficacy of our current and future products and our competitive market position, financial condition and results of operations. These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements. Review today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents in the investors section of our website at www.glaukos.com. With that, I would like to turn the call over to our President and CEO, Tom Burns.

Good afternoon, and thank you for joining us today. Today, Glaukos reported second quarter net sales of $43.2 million, up 5% versus the year-ago quarter and up 8% sequentially. Given our solid performance through the first half of this year, we are raising our 2018 net sales guidance range to $162 million to $166 million versus our previous range of $160 million to $165 million. Joe will discuss our financial results and outlook in more detail later in the call. In addition to our strong financial performance in the second quarter, we also achieved a pivotal milestone by obtaining U.S. FDA approval of the iStent inject, our next generation Trabecular Micro-Bypass device. This approval which we announced in June, represents a major step forward in the pursuit of our mission to transform glaucoma therapy and further strengthens our position at the forefront of micro scale innovation. Coming less than 6 months after initial PMA submission, this approval came ahead of our expectations as you know and also ahead of a competitor's application that was submitted months before ours. I could not be more pleased with the dynamics that led to this exceptional outcome, namely the thoroughness of our PMA submission, the strong capabilities of our clinical and regulatory organization and our constructive working relationship with the FDA. We truly appreciate the diligent work of the FDA to conduct a thorough, thoughtful and efficient review process. We're also grateful to the investigators and patients who participated in the clinical trial and helped to bring iStent inject to the United States. As a reminder, iStent inject is designed to optimize the natural physiologic outflow of aqueous humor by creating two patent bypasses through the trabecular meshwork, resulting in multi-directional flow through Schlemm's canal. It includes two heparin-coated titanium stents preloaded into an auto injection system that is designed to allow the surgeon to precisely implant stents into two trabecular meshwork locations through a single corneal entry in a straightforward click and release motion. The iStent inject is based on the same fluidic method of action as our first generation iStent, which has been implanted in more than 400,000 eyes worldwide since its introduction and has earned an outstanding reputation of demonstrated efficacy and safety. The iStent inject is quickly establishing its similarly strong track record. It is already commercially available in numerous markets outside the United States where more than 30,000 have been implanted to date. In addition, we've already had 10 peer-reviewed clinical publications and various additional studies presented at major scientific meetings that continue to confirm iStent inject's ability to achieve sustained IOP reductions that are equivalent or better than U.S. pivotal trial results. Given these results, the elegance and facility of the implant procedure, the rapid rate of adoption in international markets and recent industry surveys that reveal profound surgeon awareness, appetite and interest, we believe the iStent inject will be a compelling new treatment option for U.S. ophthalmic surgeons. Over the course of 2018, we've been scaling, manufacturing and building necessary launch inventories, finalizing marketing campaigns and readying the U.S. sales organization in anticipation of iStent inject U.S. commercialization. We have completed the final labeling paperwork with the FDA and trained surgeons have already successfully completed several initial iStent inject procedures. We will begin our full commercial launch activities later this month, following the completion of our final sales force training activities that are currently underway. Our initial focus will be on converting our existing installed base of trained U.S. iStent surgeons. We will follow the same blueprint that proved successful in the iStent launch, a controlled methodical, tactical launch that relies on superlative sales rep training and skills transfer to the surgeon to achieve optimal procedural proficiency and patient safety. As we've always said, good outcomes translate into good long-term utilization. I'm delighted with our team's preparations to this point and believe we have built a comprehensive and thorough launch plan that we are beginning to execute. Joe will provide additional financial implications to consider around the launch of iStent inject later in the call. iStent inject represents the first of 5 distinct pipeline products targeted for U.S. commercialization over the next 5 years, which we refer to as our 5 in 5 growth strategy. Regarding this pipeline, we have some exciting new developments we'd like to share with you today. Since unveiling the initial iDose Travoprost Phase II data last September and further validating the platform's viability in early 2018 with an interim cohort showing sustained efficacy through 12 months, the response from the ophthalmic community has been extremely positive. The encouraging standards building on our iDose Travoprost was increasingly evident at the April ASCRS meeting where the full data set was presented to the broader surgeon community for the first time. Based on overwhelmingly positive surgeon feedback, we came away from ASCRS with additional confidence that the commercial prospects for a viable continuous glaucoma drug delivery treatment option are substantial. It is now abundantly clear to us that achieving the earliest possible U.S. commercial entry date for iDose Travoprost should be our highest priority, given its potential for broad label that could serve 3 million U.S. eyes annually. We believe this can provide the optimal return on investment for Glaukos and our shareholders while advancing the standard of care for the ophthalmic community and glaucoma patients. To that end, we're accelerating our clinical development work with iDose Travoprost in an effort to expedite the pivotal studies required to support our NDA submission. Based on a combination of activities already undertaken and those planned, we are now targeting FDA approval for iDose one year earlier than our previous target, now in late 2021 to 2022 versus late 2022 to 2023, previously. The Phase III iDose Travoprost clinical program consists of 2 concurrent prospective randomized double-blind pivotal trials, both of which will now be primarily at U.S. clinical sites rather than split between U.S. and OU sites, as previously communicated. In order to expedite patient enrollment for the second required concurrent iDose trial, Travoprost trial in the U.S., we have immediately repurposed our 20-plus iStent SA investigator sites and recruited additional investigators that are eager to participate. We plan to enroll a total of approximately 1,100 ocular hypertensive or open-angle glaucoma subjects across both U.S. iDose pivotal studies. We're happy to announce the strategy is off to a great start and we've already begun patient enrollment for both of these pivotal studies. The European investigators that were previously planning to be involved in the second iDose pivotal trial to support U.S. approval will now be redirected to perform additional planned clinical studies that will support iDose European approvals, reimbursement and other local market support activities. In addition, our efforts to seek regulatory approvals for iDose Travoprost in Japan continue to progress as planned. The trade-off of this strategic decision is to recommence recruitment of iStent SA with the same U.S. investigators, once the iDose Travoprost trials are fully enrolled. By doing so, we now project the commercial launch of iStent SA towards the latter part of the planning period, by 2023. While we actively recruit our iDose pivotal trials, we'll also begin recruitment for our 510(k) pivotal trial for iStent infinite, our 3-stent standalone product for advanced and refractory glaucoma patients. Following the submission of our IDE application to FDA at the beginning of 2018, we are delighted to announce that we have finalized the trial design and protocol with the FDA for a prospective multicenter single-arm clinical trial and expect to begin enrolling these patients over the coming months, well ahead of our initial timing expectations by year-end. We continue to target FDA approval for iStent infinite in the late 2020 to '21 time period. Finally, the two-year patient follow-up in the pivotal trial for iStent Supra, our suprachoroidal shunt will be complete in the first quarter of 2019, and we continue to target FDA approval in 2020. As you can see by the investments we're making, I'm excited about what we're accomplishing on the pharmaceutical side of the business. If ultimately FDA approved, we believe iDose Travoprost will not only be instrumental in addressing the challenges of patient noncompliance with topical glaucoma medications, but also pave the way for a new treatment algorithm, where surgeons use iDose alone or in combination with other therapies, including our suite of surgical flow devices to more effectively manage patient's IOP. What's more, we believe the powerful iDose Travoprost data available thus far underscores the potential of our iDose drug delivery platform to produce future generations of sustained therapies for glaucoma and potentially other ocular diseases. To that end, we're happy to announce that we've entered into a pharmaceutical development agreement with D. Western Technology Institute to begin joint research efforts using compounds from their proprietary rho kinase, also known as ROCK, inhibitor compound library. D. Western is a -- highly respected in the industry as the preeminent research organization for proprietary ROCK inhibitors with a proven track record in drug discovery. We're excited to commence the initial phase of this collaborative research effort to explore potential new compounds that may be used on our novel iDose drug delivery platform. Our growing team of seasoned scientists, chemists and other experts, most of who have extensive prior experience at leading pharmaceutical companies, remain actively exploring novel sustained pharmaceutical treatment options and pathways. We believe that this collaboration with D. Western will only help to further expand our pharmaceutical capabilities moving forward. Moving on to the continued commercial progress in our direct international markets. Momentum continues to build internationally with second quarter 2018 OUS sales growth of 63% year-over-year. Brazil, Germany, Japan and the U.K. drove the majority of international year-over-year growth this quarter. During the second quarter, we're delighted to learn that after a more than 5-year process, the French health authority has designated iStent inject to be registered on the list ensue or add-on list, which provides hospitals with the required financial reimbursement coverage to use a new technology. This inclusion was based on the evaluation of the national committee with -- the evaluation of medical devices and health technologies. With iStent inject now included in the list ensue , the next step will be to work with our French Ministry of Health pricing committee to determine pricing, which we hope to finalize sometime next year. While we do not expect this development to have a material financial impact this year, we believe it represents a meaningful longer-term opportunity abroad. And finally, regarding our patent litigation against iVantus, all actions to date have proceeded as expected. Note that defendants in patent matters often bring counter claims or search for third-party patents to buy and try to assert against plaintiff. Public filings suggest that iVantus is following this typical defensive playbook with the recent acquisition of several patents that originate from excimer laser technology. These patents issued from applications filed after the priority date of the patents we are asserting against iVantus. We're not surprised by this tactic and whether or not iVantus seeks to assert these acquired patents, we remain very confident in our positions in this matter. So with that, I'll turn the call over to Joe for a summary of the second quarter financial results. Joe?

Thanks, Tom. As noted earlier, net sales for the second quarter of 2018 were $43.2 million, a year-over-year increase of 5%. The U.S. represented 84% of our sales in the quarter, and international 16%. In the U.S., second quarter 2018 sales were $36.3 million, down 2% from the same period a year ago. ASPs remained stable versus a year ago and prior quarters. Outside the U.S., second quarter sales were $6.9 million, an increase of 63% from the same period a year ago. This quarter, as Tom indicated, Brazil, Germany, Japan and the U.K. drove the majority of the year-over-year increase, led by growing iStent inject sales. Our gross margin in the second quarter was roughly 85.7% versus 86.6% in the same quarter in 2017. As expected, we did incur some manufacturing inefficiencies during the quarter associated with the scaling of our inject inventory. We continue to expect our gross margins to remain in the mid-80s percent range going forward, as we navigate the U.S. inject launch from an operations perspective. SG&A expenses in the second quarter rose 16% to $28.6 million versus $24.7 million in the year-ago quarter. This rise reflects higher personnel and other costs related to the ongoing expansion of our domestic and global infrastructure, primarily in our commercial and international operations. R&D expenses rose 31% in the second quarter to $12.6 million versus $9.6 million in the same year ago period, excluding the one-time in-process R&D charge of $5.3 million in the second quarter of 2017. This rise reflects primarily the cost of additional personnel as we expand our pharmaceutical R&D capabilities and within clinical affairs, where we are managing an increasing number of clinical studies and associated investigational sites and study investigators as we commence key pivotal trials this year. We finished the second quarter with a net loss of $5.4 million or $0.15 per diluted share compared to a net loss of $3.3 million or $0.10 per diluted share in the second quarter of 2017, which included the in-process R&D charge last year. Our net loss this quarter did include other nonoperating unrealized foreign currency expenses associated with our intercompany loans of approximately $1.7 million or $0.05 per share. As of June 30, 2018, we had cash, cash equivalents and short-term invested -- investments of $120.1 million compared to $113.8 million at the end of the first quarter of 2018. As we said before, it is important to remind you that as we progress through 2018, our primary focus remains on long-term growth as we prudently invest to build the MIGS market, drive increased penetration of our iStent and iStent inject platforms globally, and advance our robust pipeline initiatives through the necessary clinical studies and programs. Finally, as Tom indicated earlier, we are raising our 2018 net sales guidance to $162 million to $166 million, up from our previous range of $160 million to $165 million. This guidance outlook takes into account the expansion of our international sales, which we now expect to be in the range of $25 million to $27 million for the full year, up from our previous range of $23 million to $26 million. Now that we've received the U.S. FDA approval for iStent inject, we would like to take a moment to provide some high-level comments on potential financial considerations for this important launch over the remainder of 2018. First, as previously discussed, we expect the inject launch to temporarily impact the overall pace of new doctor training as physicians may elect to wait for inject while the sales force primarily focuses on conversion of existing accounts to inject; second, we expect customers will manage down their own inventory levels ahead of converting from iStent to inject, which may cause a transient disruption in ordering patterns. We expect this channel destocking will impact the third quarter and, to a lesser degree, the fourth quarter; finally, we do anticipate ordinary course sampling of inject to occur during the account conversion and training processes. As a result, we expect third quarter net sales to be down sequentially, which has been reflected in our upwardly revised 2018 sales guidance. And with that, I'll now turn the call back to Tom.

All right. Thanks, Joe. To recap, Glaukos delivered strong financial performance in the second quarter and achieved a historic milestone with the FDA approval of iStent inject. We're extremely excited and believe we're well prepared to commence the initial commercial launch activities of iStent inject in the United States. At the same time, we continue to deepen our penetration in direct international markets, further our optimized 5 in 5 pipeline strategy with the acceleration of the iDose Travoprost U.S. pivotal studies and expand our pharmaceutical capabilities as we continue to advance our aspirational mission to transform glaucoma therapy. We believe Glaukos' robust pipeline of 5 distinct products targeted for introduction to the U.S. market over the next 5 years is capable of truly changing the glaucoma treatment algorithm, setting a new standard of care and positioning Glaukos for sustained competitive advantage in an expanding global market that we feel will enable us to drive shareholder value for years to come. So with that, I'll open the call to questions. Operator?

[Operator Instructions]. Your first question is from Bob Hopkins from Bank of America.

I would just -- first couple of questions just on the, kind of on the quarter, and then I wanted to ask about some of the important pipeline updates that you gave. So first, just on the actual quarter. When will iStent inject be kind of in full launch, number one. And then number two, could you just give us your thoughts on what you thought the market grew in Q2?

Bob, this is Chris. I'm going to talk about the iStent inject launch. We are in the process of doing that now. We've had our first implants and we are moving forward with that program.

And I think I would just add to that, piece of it, Bob, that, clearly as we said we're going to have a controlled launch through the remainder of the year. And as we turn the corner to next year we'll hopefully find ourselves in full go mode with respect to that launch. On the market growth, I think, that it's fair to say we believe the market continued to grow a little above the 20% full year target in the second quarter and that was expected. Overall, we may be trending slightly above our 20% growth rate expectations for the year, but there are a lot of moving parts in the second half as you know. And we expect the second half to trend down from the first as we train far fewer doctors and we manage through the other transitory headwinds associated with the inject launch that we've mentioned previously. I should also note that, I think, at your conference actually, we commented we feel like we have a pretty good handle on the MIGS market today. And, I think, it's worth noting that as the trying and trialing or utilization of CyPass occurs, it's occurring the vast majority of time, if not all, with existing iStent surgeons and accounts. So that gives us pretty good insight that the account level and the macro level as to what's happening in the MIGS market and the growth associated with it.

So two other things I'd love you to comment on. One is regarding the updated guidance, which I realize you're raising a little bit, but given that the approval came a full quarter earlier, I guess, I'm just a little surprised that the guidance raise isn't a bit more. So maybe if you wouldn't mind talking about, in a little more detail, some of the disruption that you're expecting? And then the other thing that, I think, people would really like to hear about is, it sounds you've made a bit of a strategic decision on iStent SA, which I thought addressed the much larger market opportunity for you guys in terms of a standalone product. And it seems like that's now been pushed out by two years. I'm just curious as to why that's happening given that it represents such a much bigger market opportunity than the one you're addressing today. So if wouldn't mind commenting on those two things, I think it'd be much appreciated.

Maybe I'll start with the comments or the question around the guidance. Clearly, the approval came ahead of our base case internal expectations as you know and that's all positive, but as you can see from our maintained U.S. guidance, I'm not sure that early approval will meaningfully change 2018, as we sit here today, as we navigate our way through the conversion to inject. And I'm happy to elaborate a little bit and then answer any specific questions on the dynamics in play, but to repeat what we said in the prepared remarks and we do expect the new doctor training to be disrupted in the second half. We've always expected that. Now the timing is, obviously, a bit more clear. Probably more importantly, now I would say that what we see from the transient ordering pattern disruption and what's effectively a destocking of the channel inventory ahead of conversion, it's certainly an important consideration of third quarter. When you start to see that pick back up in the channel to sort of see its inventory levels return to normal is a good question. It depends a little bit on the exact pace in which we pursue the conversion here in the coming months and quarters. And then lastly, as I said, the ordinary course sampling of inject, we expect that to occur over the third and fourth quarters as a bit of a headwind to the 2018 business. And then lastly, I mean, I guess, part of, as we think about the overall guidance, we actually think about the O.U.S. as well and some of the seasonality patterns there are different from the U.S. and we expect a summer slowdown in the EU. And finally, I guess I would add that with the strengthening of the dollar over the last 60, 90 days, it certainly could present a bit of a headwind when comparing the second half of the year to the first half.

And Bob, if I can I'll address the strategic decision to reprioritize some of the clinical studies that we're doing. And, I think, it's important that investors understand how profoundly beneficial this can be to the company and to the investment community. When we look at iDose, we came out of the ASCRS meeting and we had presented the interim cohort data at one year to the ophthalmic audience for the first time, again, which showed that iDose reduced intraocular pressures from 7.9 to about 8.5 millimeters of mercury at one year. The response was overwhelming and reconfirmed our belief that this is going to be an incredible product in the hands of ophthalmologists. And so as we look at the opportunity, to me, there's orders of magnitude difference between the iDose opportunity, as we stated all along. We presented data that iDose is going to address approximately 3 million annual opportunities for implantation in the United States versus roughly 500,000 for iStent inject SA. So we look at that, we're looking at a broad label for iDose, which should be all the way from ocular hypertensive to moderate open-angle glaucoma, which really gives us the benefit of covering the full portfolio of glaucoma patients. And, again, this is a potential annuity product that people will use continually and that we hope reinsert on depletion of the drug and medication. So the opportunity is profound in terms of an annuity product. iStent inject SA is a very important product. It will cover pseudophakic patients in the mild to moderate glaucoma range and it's going to serve approximately, by our estimations, about 500,000 patients annually. So when we looked at the differences, they were profound. And when we looked at the opportunity to make the change, we did so. So what we did is, we took the iStent SA investigators that currently were dedicated to the iStent inject trial, and we actually moved them to be able to introduce and to be able to -- the investigators for iDose. There was unanimity of conversion of surgeons that wanted to give the iDose trial. The other thing that's important to note is why do we move out from a year, how do we make that happen? Well, as we saw all along the European pivotal trial for iDose wasn't going to start until the end of this year. And then as we all know, to be able to get IRB approvals and ministry of health approvals in Europe, are far more onerous and lengthy than they are here in the United States. So the European trial was the long tent in the pole in order to be able to fully realize these 2 concurrent trials and submit our NDA. And by moving those into United States with apt investigators that are already primed and ready to go for iStent inject SA, we're able to move this profound opportunity up by year. We're still committed to iStent inject -- or iStent SA. We will enroll that clinical trial once we've enrolled, fully enrolled the iDose trial. So to us, it was a self-evident decision once we really put the numbers down and we realized the acclaim that we received from the ASCRS meeting, I immediately commissioned the clinical and regulatory team here to give me options on how I could get to the market quicker with iDose. And that's why we made the decision. We think important and we think it's a profoundly opportunistic incisions for -- decision for us and for investors.

Your next question comes from Larry Biegelsen from Wells Fargo.

A bunch on inject. Maybe I'll just break it up here. Price premium, I think, most of us are assuming about 5%. And can you quantify the inventory drawdown that you're expecting in the third quarter? And I have a bunch of follow-ups on inject.

Yes, this is Joe, Larry, hi. So I think first on your question around the price, I think all we've ever said is that we do expect to have a premium for what we see as a premium product. We've not quantified beyond that what our expectations are to investors. Second, when you think about the quantification, it's difficult to do that. I mean, we've seen some of this actually start to occur over the course of the month of June, towards the end of the second quarter. So we're confident it will continue in the third quarter. The question really becomes as we start rolling out the conversion itself, how quickly do those ordering patterns reestablish? So it's a difficult question to quantify, other than we do know it's happening. It's happening right now. We can see it analytically. And we expect it to continue in the third quarter.

And then Tom, on inject, can you talk about what you think it means for the market in terms of accelerating the market growth 20-plus percent this year? I'm thinking more about, let's say, 2019 and beyond. Does this acceleration come from deeper penetration, new users? What impact do you think it can have on your share? And just when we look at the second half guidance of basically negative 4 to plus 1, I think, implied. Can you grow at a healthy rate in 2019?

Larry, this is Chris. I'm going to address the market opportunity for iStent inject. We've seen that in Australia and in Canada and Germany and now the U.K that iStent inject has had a profound impact on the growth of MIGS within those perspective countries. More people are inclined to utilize this product because of its efficacy, its safety profile and the ease of use that's associated with it. So I would expect similar results here in the United States. We've said all along that there are surgeons out there that are not as comfortable implanting an iStent as they will with the iStent inject. So we are pretty bullish on how this product will perform and the impact it'll have on the market here in United States.

Then Larry, It's Joe. I think, I would, I mean, inherent to what Chris is just saying, it clearly is an expectation that we should be able to take the next leg of growth in the marketplace in 2019 and beyond with this important product and its launch. As I think about second part of your question around guidance and then how it translates into 2019. Clearly, we haven't given 2019 guidance yet, but there's a number of factors there. Inject is clearly part of it in the restoration of growth in our U.S. franchise. But you also have to think about the factor of sort of where we're at from the competitive evolution standpoint too. So with the entry of CyPass in the market in the second half of last year, you had difficult comps, if you will, through the course of 2018. As we enter into 2019 you'll have had a full year of CyPass being on the market that we're comparing against. So clearly, we expect both that to translate into better market growth as well as growth for us specifically.

You're next question comes from Brian Weinstein from William Blair.

Tom, maybe for you, on the SA. Just want to confirm the reason for pushing it is really a prioritization. You didn't see anything wrong with any data, anything outside the U.S. or any negative feedback on SA that caused you to make this decision, correct?

Not at all. I mean, we were able to look at the Phase I data, as you recall. We were changing our randomization schedule from 2 to 1, to 1 to 1 as we entered the expanded phase clinical trial. So because it wasn't poolable, we were able to unmask the data. We've assessed the data. We like the fact that we have that data in hand, because it will allow us to make appropriate modest changes to clinical protocol. When we do start to enroll the trial once we've subsequently concluded the investigational pivotal trial for iDose. So the answer is no. This is again, as I said before, it clearly became a profound opportunity that was facing us to make the change. And in the end, we'll have both products. I just want the product that has 3 million eyes upfront far earlier in the commercial cycle than I want one that has 0.5 million patients. It's that simple.

Yes. That makes a lot of sense. Is there a reason -- is it just a limited amount of time that these investigators have that you couldn't be running these things at full speed and running them, kind of, concurrently? Was there a reason you can't do that?

Yes, there is. I mean these -- there are only so many sites that are productive and as you look in United States in scale, if we're trying to run those sites simultaneously, they would be cannibalizing opportunities. And I think it would just draw out and extend the range of both trials beyond what our expectation would be. And so -- and there's also limited resources in the company, right? So as I look at it, and I take the ability to take these and concentrate and put them fully on iDose, I can move this study up, again, a full year to bring it to the marketplace. And once I'm done, I can turn the turrets and put these people right on iStent SA and make good progress in that as well. So the short answer is, there would be cannibalization between the investigative groups given the protocols and this is the right decision for the company.

Got it. And then, Chris, for you on inject. Can you talk about what the typical training process is going to look like, number of cases that people are going to have to do? And what the trailing amount, kind of, per doc that we should we thinking about would be for utilization of product?

Sure. We're committed as we always are to superlative skill transfer to the surgeons. The people that we're focusing on right now, the customers that we're focusing on right now, are iStent users. So the training will be a bit modified compared to what it's been in the past. They've already been through the visualization anatomy by manual technique training. Now we're really focusing with these guys and gals on the iStent inject itself and the nuances there. So typically, that will take roughly 5 cases, it could be more. And we go in there, we do a dry lab like we do with iStent the night before and then we proctor them in surgery and it may take 1 day, 2 days, 3 days. Whatever it takes to make sure that they're proficient at implanting this device so that they get good outcomes so that we get continued business from these customers. As it relates to new surgeons, they will get the full-blown training program that we have done in the past where they'll be taking a webinar at their convenience, they'll get the dry lab and I would expect that those cases to be in the anywhere from 10 to 20 range depending on the position.

Your next question comes from Robbie Marcus from JPMorgan.

This is actually Christian on for Robbie. Maybe just one on what you're seeing in the competitive landscape. In terms of your raised guidance for the year, how are you thinking about advances coming on? Do you still expect to receive FDA approval later this year? And then beyond that, how do you think about the market in terms of having three competitors there just from a high level?

Hey, Christian, this is Chris. We have no reason to believe that they won't get approval this year. We're prepared for that. In fact, we've been training the sales reps on that entry. So similar to what happened with CyPass, we expect them to go to our customers who are already trained. We expect them to provide anywhere from 5 to 10 samples for surgeons to try that. We expect that most of our surgeons will try it. There's an appetite for trialing new products in the ophthalmic community. So similar to CyPass, we expect that they will do that and that the majority of those physicians will be iStent or iStent inject customers.

And I would just add that the compassion that we've factored that into our thinking around the guidance for the remainder of the year. It's obviously difficult to know exactly when that trying and trialing activity will start to occur, but we looked at a variety of scenarios and incorporate that into our thinking around guidance.

That's helpful. And then just one on kind of the clinical strategy here with the update on the call, it's been very helpful. In terms of transitioning these primary investigators from working on the SA trial to now moving them to iDose. Is there any kind of disruption or friction that happens in that process? And just in terms of thinking about cost and timing, how long does it take for them to really, turn the light switch off on SA and on, on iDose? If you could just walk us through that process.

Yes, I'd be happy to. The very important and good news is we've already begun enrolling in the clinical trial for the iStent SA investigators that have converted over to iDose. So it's been relatively seamless. Obviously, what they have to do is once they get the new protocols, they have to -- we have to do site visits and then we have to get IRB approval. That's all been done. So we were able to do that in a very efficient manner. So both of these pivotal trial start at the same time. And that's important because remember, when these trials finish up, it doesn't help us if one finishes several months in advance of the other because we need both trials to finish in order to submit our NDA. So I would say the process was seamless. I would actually say that there was a strong appetite and delight among -- against -- or with most investigators on making the change. And we were very, very pleased by that. So the studies have already begun and I should tell you that we've already enrolled our first iDose clinical study patients as of today.

Your next question comes from Matt O'Brien from Piper Jaffray.

Tom, can we just stick on this iDose topic a bit more? And sorry for beating the dead horse here. But the push-out on SA is going to be concerning for investors, but the acceleration, the timing for iDose, I think, offsets that just given the TAM there comparatively speaking. So can you talk a little bit about the ability of this group now to get a lot more patients through faster? What gets you to 2021 in terms of approval versus 2022? Where are some lever points there? And when can we expect some new data readouts given the advanced -- or the accelerated timing?

So let me address. And just tell you again that as we look at the iDose clinical trial and we evaluate where we can pull the levers to be able to bring this forward. Again, it's important to note as I've told the investment community before, that the European pivotal trial for iDose would start later this year, right? And we were already set for mid-year launch as you know of the U.S. trial. So the European trial already lagged and we were prepared for that. But then when we looked at the Ministry of Health approvals and the IRBs and kind of the onerous nature of getting these sites qualified, there's a potential for those to go further out than we would have liked, okay? So the European trial was the long tent -- long pole in the tent. And so by taking the investigators that were on iStent SA and moving them over, with the beneficiary of the kind of superlative IRB path that we already laid out for the first pivotal phase in which we're well acquainted. And we're able to seamlessly move those investigators into this pivotal trial and so that both of these commenced at the same time. And my hope is that they finish relatively in order, in order for us to be able to submit our NDA earlier. So as we do our target approach of when we think this will be available, we gained a full year and again, as I look at a $3 million -- or sorry a 3 million patient annual opportunity that's an annuity that will keep on giving. To me, the decision was straightforward and easy. And that's why I made the change.

Okay and what gets you the 2021 versus 2022?

Just to reiterate, because in the initial estimations, we had already planned for Europe to lag the U.S. By moving inject SA into this pivotal trial, the investigators in the pivotal trial, we gained by our estimation a full year by not having to go through kind of the onerous approvals, administrative health and IRBs as well as the start later this year. I think the European trial was lagging the U.S. by about 6 months or so. So we picked up time, we picked up opportunity and we think this means a profound beneficial change to the business.

Okay, I'll follow up with that question offline. And then as far as the D. Western relationship goes, is that just going to be for glaucoma or are you going to after other conditions? And when might we start thinking about some types of products here? Is it within that 5-year timeframe that you talked about for the rest of the portfolio?

Let's talk about D. Western, first. As you do your homework, D. Western is a Japanese publicly traded company that really is a huge purveyor of ROCK inhibitors. They already have 3 compounds that they're in committed commercial relationships with partners. One of which is approved in Japan. So this is a powerhouse and coming out with the catalog of rho kinase inhibitors. So we were delighted that we were able to access the technology and be able to establish an agreement where in the agreement, we really have an upfront technology access fee and research support fee and if one or more candidate compounds are identified that Glaukos holds a exclusive right to develop these novel intracameral and topical products of these compounds, really through the licensing arrangement with DWTI. So as we talked about, we have always talked about having the beakers swirling here, looking for small molecules with low nanomolar concentration that are highly insoluble. We think that the opportunity with D. Western offers us a pretty good shot on goal to be able to come up with a novel rho kinase inhibitor that may be effective in our iDose platform. So we're excited. It's one of several options that we're looking at. But I think it's an important notion. I think also indicates to the investment community just how affirmative our conviction is into moving to become a hybrid pharmaceutical medical device company.

You're next questioning comes from Jonathan Block from Stifel.

Apologies in advance, I'm on multiple calls so maybe I get a pass if I'm a bit redundant. But first one on iDose. Tom, can you remind us of the reimbursement landscape once you get there? In other words, I know there's a debate if it's 2021 or 2022. But once you get there, do you need to pioneer codes and go for reimbursement at that point in time? Or is there anything you can do to facilitate things in advance?

Yes. So when you're looking, Jon, at a drug, this is an NDA, the normal course will be to get a J-code when we get approved. That's a very straightforward process undertaken daily by multiple pharmaceutical companies. In addition, what we'll be doing is we'll be doing the work to establish a new professional fee code that's likely to be a Category III code, much like we've done with iStent inject and iStent Supra. And so, we want to be -- put clinicians in the position of being able to put in multiple products, that is, our iDose, iStent Infinite for instance, and possibly, iStent Supra and be able to, through the medicare reduction rule still be reimbursed from a professional fee standpoint. So it's a straightforward process. It's one we're well acquainted with, and yes, we'll be prepared when we -- when and if we do receive FDA approval.

Okay. And then, Joe, this one might be for you, but the long-term growth trajectory at the concomitant market, I think that's going to clearly come into greater focus now that SA is pushed out. And so, we had the market growing at 20% last year. You've thrown out 20%, now maybe 20% plus in '18. But can you talk about how that evolves a sustainability behind 20%? I mean, does it stay there, does it continue to decelerate? And I ask that question because when you look out over the next three years, this is sort of the market you're playing in and a market that probably goes from two players to three players.

Sure. Jon, I guess, first I might just say that obviously by bringing forward iDose, we won't be just playing in the concomitant market. That obviously would take us directly into the stand-alone market with the broadest label possible in that opportunity. But within the combo cataract market and your question specifically, I think earlier, we talked about this a little bit with Chris, where certainly as we turn towards 2019, it's hard to look that much further beyond that. The inject opportunity is market expanding, right, for all the reasons we've talked about in the past and continue to reiterate here. Our belief is that whether it's through the increased efficacy, ease of use, the ability to really open up both the lower-volume surgeons as well as some of the higher-volume surgeons that have not yet converted, we feel good about what that means for the market development and market growth in 2019.

You're next question comes from Chris Cooley from Stephens.

Apologies I've doubled on two calls here as well, like Jonathan, but may be two from me. First, did you touch on just the contributions or the drivers, I should say, for the sequential downturn? I understand the process there from the 2Q to the 3Q. But could you may be bracket a little bit for us between the stocking, the training, in-market forces? And then on the development side with DWTI, it's really exciting to see you moving forward on that front. But you could you contrast why you selected DWTI versus another ROCK inhibitor player, which is maybe right in your own backyard for -- maybe potentially a little farther along with that drug? Just kind of curious what you see in the DWTI space versus maybe others?

Chris, it's Joe. I might -- I'll start off with your question around the second half dynamics in the third quarter. We didn't quantify some of the dynamics that you're asking about, but what I can do is, sort of, put them in context in maybe the order of importance. I think the #1 thing that is happening in the third quarter is really this transient ordering pattern disruption that we're talking about. Effectively the destocking of the channel inventory ahead of conversion. At any given time we'll have several thousand units estimated in the channel, if you will, from an inventory standpoint. And as we shift those accounts from iStent to inject, we expect them to manage their own inventory levels ahead of that conversion and that does disrupt the ordering pattern. Second, I think, in the near term it's just the ordinary course sampling of inject. You can imagine, again, that's transitory as we sort of make the conversion. And then third, is really the new doctor training and the disruptions that we've talked a lot about in the past.

And Chris, yes. I think you probably missed some of my statements upfront, but DWTI is an absolutely prolific purveyor of ROCK inhibitors. They've already developed 3 ROCK inhibitors that they're in committed commercial relationships with partners. One of which is approved in Japan. And this gives us an opportunity to develop a novel proprietary compound that really fits with the iDose platform so we can take it from its inception and be able to really customize, potentially, a ROCK inhibitor that will provide the right allusion rate and to drive therapeutic index in an intracameral fashion. So it is beyond the right decision. They are well recognized as a very, very sterling producer of ROCK inhibitors. They've got an extensive library. When we did our due diligence, this was the right call and the right partner for us.

You're next question comes from Joanne Wuensch with BMO Capital.

This is Matt Henriksson in for Joanne. Just continuing on the iDose shift in trials. Now that both trials are in the U.S., are there any differences between 2 cohorts?

Yes, so the cohorts that we have established and the protocols are nearly identical. And so we're still talking with the FDA and so many protocol amendments to finalize, which companies normally do in the process of a clinical trial. But I will tell you that both protocols are nearly identical.

Okay, great. And then just one follow-up on iStent inject. For training surgeons that have -- legacy surgeons, let's call them. Do you see the same trajectory of training them with iStent inject as you did with the first generation device?

No, for existing surgeons, the answer is no. Obviously, when it's a new surgeon, which all of the original iStent trainings work, that was a much longer training regimen from start to finish including a lot more proctored cases with our sales force. But sitting here as you're converting existing surgeons over, I think Chris has gone on record in the past as saying that's really 3 to 5 cases on average for these doctors to get proficient with the new procedure.

Okay, but the number of surgeons that you train per quarter, that trajectory will be then faster?

Oh okay, I'm sorry. Yes, that would be faster. So obviously, in the initial launch over this last several years and the pace in which we trained surgeons, we would certainly expect to convert the existing surgeon base much more quickly than that history.

[Operator Instructions]. The next question is from Larry Biegelsen from Wells Fargo.

Just one on infinite, one in iDose. So on infinite, Tom, is the trial designed similar to what you expected, what you've described in the past? And I'm just wondering if infinite -- the expedited pathway via 510(k) was a factor in your decision to expedite iDose and push out SA? The indications aren't identical, Tom, but there is some overlap. And I have one follow up on iDose.

Well, I appreciate your question. Because it did have an impact on our thinking. iStent infinite is a standalone opportunity. And it actually is a superlative product with three stents, as you know, and you've seen some of the early data. So the clinical trial is a 510(k) path, again, which is typically as an expedited path. And we expect to be in the marketplace in the late 2020 to '21 time period, similar to what we had initially stated for iStent SA. And so when we do get this approval, if we are smart and we create clinical trials that in a peer review basis show the benefit of iStent infinite in patients across a broad spectrum of glaucoma, there is opportunity for payers to look at these peer-reviewed clinical trials and actually cover the product if we can come up with data that's commensurate with a standard of high clinical use. So it's an important opportunity. It did go into our thinking. iStent infinite is a product that over the long term, we're entirely excited about. And we're going to get there in the same time period that we would with iStent and iStent SA. So in regards to the protocol question, very -- we were able to move our date as you recall. I told the investment community that we would look to have approval of iStent infinite 510(k) protocol by the end of the year. And we moved that up several months and in negotiations with the FDA, the protocol for the trial are for refractory patients. The FDA has been a little bit more stringent on maximally tolerated medical therapy. So we continue to enter into deliberations with them to try to expand the clinical protocol to allow us to enroll maximally tolerated patients as well. And we hope to get there, but we're excited that we're able to get there early and we're excited about the possibility for iStent infinite as a standalone product as well. And thanks for asking.

And then lastly, Tom, any reaction to the bimatoprost SR Phase III data that came out earlier this quarter?

Sure. No real reaction other than the product appears to perform as it has in the past. Again, this is a biorotable that's injected into the eye and the data that I've seen, the product is designed to last typically for a period of about 4 to 6 months. And so if our data holds with iDose, we're looking at a product that is already 2 to 3x the sustainability of what we're seeing with bimatoprost SR. So that's why we're entirely excited. We like the fact that it's positioned and anchored versus kind of floating in the angle, where we have no issues of migration. So we think that the bimatoprost SR is a good product and good entry, but we're terribly excited about our product.

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

Okay. I want to thank you all for your time and attention today and again, for your continued interest in and support of Glaukos. Thanks, very much and goodbye.