Welcome to Glaukos Corporation's Fourth Quarter and Full Year 2019 Fiscal 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 and Development. Please go ahead..

Thank you and good afternoon. Joining me today are Glaukos President and CEO, Tom Burns; CFO, Joe Gilliam; and COO, Chris Calcaterra. Following our prepared remarks, we'll open the call to questions. To ensure ample time and opportunity to address everyone's questions we request that you limit yourself to one question and one follow-up.

If you still have additional questions you may get back into the queue. Please note that all statements other than statements of historical facts made on this call that address activities, events or developments we expect, believe, or anticipate will or may occur in the future are forward-looking statements.

These include statements about our plans, objectives, strategies, and prospects regarding among other things, our sales, our products, our pipeline technologies, our U.S. and international commercialization efforts, the efficacy of our current and future products, 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.

Finally, please note that during today's call, we will also discuss certain non-GAAP financial measures including results on an adjusted basis.

We believe these financial measures can facilitate a more complete analysis and greater transparency into Glaukos' ongoing results of operations, particularly when comparing underlying results from period-to-period.

Please refer to the tables in our Earnings Press Release as well as the Investors Relations section of our website for a reconciliation of these measures to their most directly comparable GAAP financial measure. With that, I will turn the call over to Glaukos’ President and CEO, Tom Burns..

Good afternoon and thank you for joining us this afternoon. Today, Glaukos reported fourth quarter net sales of $65.8 million up 22% versus the year ago quarter and 13% sequentially. In 2019, net sales rose 31% to $237 million from $181.3 million in 2018. We are also providing a 2020 net sales guidance range of $290 million to $300 million.

Joe will discuss our financial results and outlook in more detail later in the call, 2019 was a dynamic year for Glaukos, as we took multiple bold steps to expand our global glaucoma business, advance our transformative market expanding pipeline and execute a strategic vision designed to establish Glaukos as a unique vision care leader with tremendous potential for long-term growth and profitability.

I am pleased by our solid performance in 2019 and confident that our best days lie ahead.

We're just beginning to unlock Glaukos’s long-term value as we leverage our core competencies to build thriving franchises in glaucoma, corneal health and retinal disease with novel therapies that disrupt conventional treatment paradigms, improve patient outcomes and create new robust market opportunities.

This summer will mark our fifth anniversary as a public company. And as we look towards what lies ahead for Glaukos, I want to first recognize and thank our employees for the significant progress we have made to create a world-class global company and the investors who have supported us along the way.

Over the past five short years, we transformed Glaukos from a single product U.S.-centric company into a true atomic leader with three FDA approved, fully commercialized products and 17 direct sales markets worldwide.

We assembled an experienced 600 person team that includes more than 250 commercial sales professionals and roughly 80 engineers, chemist and technical professionals pursuing a host of promising R&D programs.

We have more than tripled the number of publicly disclosed pipeline programs from four to 13 with another 10 yet to be disclosed development programs also underway. Financially. We have delivered compounded annual sales growth of nearly 40% from sales of $46 million in 2014 to $237 million in 2019.

We have also expanded to maintain gross margins into the mid-80s enabling us to reinvest back into the business and build a global infrastructure, strengthen our pharmaceutical expertise, upgrade enterprise systems and fund numerous R&D and clinical programs while fortifying our healthy balance sheet by doubling our net cash position from $91 million at the end of 2015 to $183 million today.

As many of you know, our ambition and long-term strategy has always included innovation and disruption of other markets beyond glaucoma, notably in the areas of corneal disorders and retina.

Behind the scenes, we have been quietly advancing the strategy by seeding development projects, attracting top tier expertise into Glaukos and in investing in the infrastructure to accelerate our research activities.

And over the last two years, we have supplemented these organic efforts with business development activities including, establishing a relationship with D. Western for ROCK inhibitor research. We secured an exclusive U.S. agreement for the Santen PreserFlo MicroShunt. We acquired Dose Medical to secure multiple retinal drug delivery programs.

We in-licensed a novel transdermal cream based drug delivery solution from Intratus, primarily for dry eye as well as other corneal disorders in glaucoma. And we acquired Avedro, establishing the cornerstone of our corneal health franchise.

So as we enter into 2020 our long-term strategic vision is not clearly in view as we leverage our strong foundation and core competencies to build disruptive franchises in glaucoma, corneal health and retina.

Within each of these areas, we're moving full speed ahead with the same pioneering discipline, skilled commercial execution and pipeline development expertise that has made us the worldwide leader of the MIGS marketplace.

In glaucoma, our goal has always been to create a full portfolio of micro-scale surgical devices and sustained pharmaceutical therapies that provide the best benefit to risk calculus at every stage of disease progression, from ocular hypertension through refractory disease and in both combo cataract and standalone procedures.

Throughout 2019, we continue to convert our U.S. surgeon base to our next generation Trabecular Bypass device, iStentinject. With this conversion now largely complete, our U.S. reps have shipped – shifted their focus back to driving utilization of existing accounts and training new surgeons who are yet to adopt MIGS. An increasing number of U.S.

surgeons continued to show growing interest in iStentinject and MIGS, which gives us confidence in the future growth potential of the combo cataract market. Nevertheless, implied in our guidance is an expectation, the competitive dynamics may be a relative headwind to grow for our U.S. glaucoma franchise in 2020 versus the overall market.

These dynamics are fluid but do not – but do include the full year impact from MIGS competitor who reached more fulsome commercial scale in the back half of 2019 along with the impact of more tissue destructive procedures that have seen increasing utilization over the course of the past year, largely due to a currently favorable reimbursement environment.

Our leadership team and commercial organization remain focused on this important area of our business and maximizing our opportunity within the combo cataract market. Outside the United States, our glaucoma franchise continues to deliver strong growth as we drive deeper penetration and broader adoption of MIGS around the globe.

International growth was broad-based across many countries, including in established markets in Germany and Australia, along with newer markets including Japan, France, and the UK. At the end of 2019, we also received regulatory approval for iStentinject in Japan.

And are now working with the Japanese regulatory body to secure appropriate reimbursement coverage to support a commercial launch by the end of 2020. Going-forward, we plan to continue to support and grow our quality experience O-U.S.

surgical sales teams, while working to optimize the reimbursement coverage and payment landscapes, train surgeons, and leverage our compelling clinical data to grow MIGS adoptions and drive deeper penetration in our 16 international countries where we have a direct market presence today.

We are also evaluating and have been making initial investments in potential future direct and hybrid markets, where favorable opportunities and reimbursement pathways exist. Turning now to progress with our glaucoma micro scale surgical pipeline. First.

in the fourth quarter of 2019, we completed patient enrollment in the pivotal trial for iStent infinite, our three stents standalone product for advanced and refractory glaucoma patients. As a reminder, this is a prospective multicenter single arm clinical trial that enrolled roughly 65 refractory subjects with a one year follow-up.

We continue to target FDA approval for iStent infinite in late 2021. Second, we are in early preparations for the potential U.S. commercial launch of Santen Pharmaceuticals’ MicroShunt, assuming FDA approval in late 2020 to early 2021.

The MicroShunt has an elegant AV external surgical implant is not only a compelling treatment alternative for late stage glaucoma management, but also marks the capstone to our glaucoma treatment algorithm.

Third, we intend to pursue iStent SA for the standalone treatment of mild to moderate open angle glaucoma following the enrollment completion of our iDose clinical trials.

Moving on to our sustained pharmaceutical glaucoma pipeline, our focus remains on creating solutions with potential to provide 24/7 continuous therapy as a viable alternative to topical medications.

It is worth reminding investors, the topical therapies are the main stain – of mainstay of glaucoma treatment and that they worked for many patients when taken properly. However, the primary issue the industry has been grappling with for decades is patient noncompliance. This is ubiquitous, well understood and documented.

With iDose, we are taking a novel and differentiated approach to address this issue for the benefit of patients. We're excited about our prospects while remaining fully aware that success will require much of the same pioneering playbook that we utilize to develop MIGS over the last decade.

iDose Travoprost now known as iDose TR is our first primary sustained pharmaceutical glaucoma and we believe it has the potential to be a game changing therapy. In 2019 we brought this breakthrough technology closer to becoming a reality who continued patient enrollment in the iDose TR Phase 3 IND clinical program.

Patient enrollment for the iDose TR is proceeding in line with our expectations to support our FDA approval target of 2022. The powerful iDose data available thus far underscores our confidence in the potential of our novel drug delivery platform to produce future generations of sustained therapies for glaucoma and potentially other ocular diseases.

Accordingly, we are in late stage development with finalized designs for next generation iDose TR extended release implant, also known as iDose TREX, which in a similar size and form factor to the original iDose TR, is designed to provide nearly twice the drug capacity to extend efficacy durations even longer.

We will be engaging with the FDA in the near future to determine the most appropriate and expeditious regulatory pathway for this novel product. We are also seeking additional drug classes that may be synergistically used in conjunction with the iDose platform. Through our research and development agreement with D.

Western, we are currently assessing multiple ROCK compounds which are showing positive reductions in rabbit models. And we're establishing prototype implants for lead candidates in these same models. ROCK inhibitors when used in conjunction with prostoglandins had been shown as a powerful treatment in reducing interocular pressure in U.S.

pivotal studies. In summary, we anticipate our glaucoma pipeline portfolio to provide a complete cascade of new product introductions over the coming years, allowing us to expand beyond the combo cataract segment into the broader glaucoma population.

As a result, we believe these pipeline platforms if approved could significantly expand our glaucoma U.S. addressable market opportunity seven fold from roughly 600,000 procedures today to over 4 million annualize.

With the targeted launches of Micro Stents in late 2020 to early 2021, iStent infinite 2021 and iDose TR in 2022 along with our promising longer term programs of iStent SA, iDose TREX, iDose Rock and the IOP Sensor program we believe we are in a powerful position to drive sustainable long-term growth in our glaucoma franchise going forward.

Turning now to our Corneal Health franchise, which is targeting a large market with significant unmet commercial and clinical needs across multiple diseases and disorders. This franchise is anchored by the Avedro business we acquired in late 2019 that brought us a proprietary bio-activated pharmaceutical therapeutic platform.

Our initial therapeutic focus is in keratoconus, a site threatening degenerative disease in which the cornea progressively thins and weakens leading to vision loss.

There are approximately 1.1 million eyes that are prevalent in United States today with annual incidents of another 32,000 eyes translating into an estimated $3 billion market opportunity. Even though keratoconus is a sight threatening disease and the leading cause of full-thickness corneal transplants in the U.S.

we believe it remains vastly undertreated. This is due primarily to under-diagnosis in the historic lack of any effective solution. Today, approximately 20% of keratoconus patients ultimately require a corneal transplant, a costly and invasive procedure with high failure rates.

In fact, literature suggests 72% of corneal graphs fail within 20 years and 98% fail within 30 years. Sadly as the disease onset is often diagnosed in teenage years here in Dakota patients may require multiple transplants over one's lifetime.

Photrexa, our flagship commercial offering today is the first ever bio-activated ophthalmic pharmaceutical therapy for the anterior segment and unlike antiquated symptomatic approaches is the first and only treatment option approved by the FDA to actually slow or halt the progression of keratoconus.

A single application of this bio-activated drug in what is known as an Epi-off procedure has shown the potential to halt disease progression with sustained durability and safety of over 10 years in the vast majority of patients according to multiple studies.

In order to maximize the availability of this important therapy for patients at the end of 2019 and over the course of 2020 we’re making substantial investments to fully integrate our commercial organization, lower the barriers for adoption by practices, increase awareness in the optometric community and resolve many of the ordinary course growing pains associated with establishment of a new J-Code.

We finalize many of these plans shortly after closing the transaction and began their formal deployment in part at our Global Sales Meeting held earlier this month where we conducted cross functional training and prepare the organization for alignment, the account targeting and market segmentation in 2020.

In addition, we are preparing a variety of marketing programs and campaigns designed to educate optometrists regarding keratoconus, increasing glycolysis present at all major optometry meetings, optimizing referral network patterns and driving awareness through paid media, social media, and other mediums.

We will also be executing on multiple business solutions for the benefit of customers and investing in health economics to further solidify the value of corneal cross-linking to patients and health systems.

Turning to the corneal health pipeline, we continue to make progress on the next generation keratoconus therapy Epi-on, which is designed to shorten procedure times, improve patient comfort and shorten recovery times.

Epi-on will deliver or utilize a proprietary novel drug formulation, stronger UVA irradiation protocol and the ability to deliver increased levels of supplemental oxygen. Patient enrollment for the pivotal Phase 3 clinical trial for Epi-on was completed in may of 2019 and we'll follow these patients for one year. We are targeting FDA approval by 2022.

Beyond keratoconus we are developing novel single application bio-activated topical ophthalmic pharmaceuticals and customize UVA beam protocols for presbyopia and other refractive conditions with our pixel therapy.

A Phase 2a multicenter clinical trial outside the United States to investigate the use of our PiXL therapy to treat patients with presbyopia is ongoing. Study results which we expect to review later this year will help us optimize the PiXL parameters and determine the most suitable U.S. clinical and regulatory pathway forward.

Finally, on Avedro to ensure we are ideally positioned to take full advantage of this opportunity. We are dedicating significant time and resources to a thoughtful and thorough corporate integration, which is being spearheaded by a team with deep experience from much larger and inquisitive organizations.

This process has been fully underway since day one, including the aforementioned expansion and realignment of responsibilities within the U.S. field sales organization.

The communication in December to Avedro employees on their specific status with respect to our retention and restructuring plans and the integration of key IT systems and facility planning.

Also on the corneal health front, we're developing a patented non-invasive transdermal drug delivery platform designed for use in the treatment of dry eye disease and potentially glaucoma and corneal disorders.

Early human studies of this novel, patient friendly delivery system have demonstrated efficacy, while limiting the side effects often associated with drugs to deliver it as topical eye drops. We are currently optimizing the lead product candidate for use in future clinical trials.

This novel drug delivery platform adds to several organic corneal health R&D initiatives we already have in place. We see this platform as an excellent opportunity to potentially enter into the $4 billion dry eye disease market with a highly differentiated approach while also exploring opportunities in glaucoma and other corners disorders.

Finally, our third area of focus is in retinal diseases. The largest market in ophthalmology today estimated at 13 billion worldwide and expected to grow nearly 10% annually through 2023.

Our retinal R&D teams are hard at work developing multiple micro invasive bio-erodible drug delivery platforms designed to treat age-related macular degeneration, diabetic macular edema, and other retinal diseases.

We have three primary sustained release development projects we're advancing that include a triamcinolone acetonide steroid targeting DME and an anti-VEGF protein, and a small molecule multikinase inhibitor targeting Wet AMD.

The goal of these preclinical programs is to ultimately provide retinal specialists and their patients with novel sustained pharmaceutical treatment options that offer a meaningfully longer duration of effect than the current standard of care.

So in summary, we're creating a unique vision care leader prepared to drive a robust cadence of new innovation that can significantly expand our market opportunities and drive sustainable growth and profitability over the next decade.

The strong foundation and team we've built leaves me confident in our ability to execute on our plan and realize the significant value creation opportunities that do lay ahead for Glaukos. And with that, I'm going to turn the call over to Joe to discuss our fourth quarter and full year 2019 financial results..

Thanks, Tom. As a reminder, I will be including non-GAAP or adjusted basis metrics to describe the highlights of our financial performance given our recent acquisition of Avedro and other non-recurring items. I will also summarize our GAAP performance later in my prepared remarks.

I encourage you to review the GAAP reconciliation of these non-GAAP measures, which can be found in today's press release as well as the investor relations section of our website. In addition, my comments today will reflect contribution from Avedro starting with the acquisition closed on November 21st unless otherwise noted.

Glaukos’ net sales for the fourth quarter of 2019 we're $65.8 million on a reported basis, a year-over-year increase of 22%. Fourth quarter performance was primarily driven by global glaucoma sales of $59.8 million, which increased 11% compared to the fourth quarter of 2018. Growth was driven by U.S.

volumes and continued strength internationally with broad-based growth across all key international regions and countries.

In corneal health, which includes the former Avedro business fourth quarter net sales were $6 million, standalone Avedro sales for the full fourth quarter of 2019 would have been approximately $12.4 million, an increase a 52% compared to the fourth quarter of 2018. The corneal health performance was almost entirely driven by U.S.

Photrexa year-over-year sales growth of 57% to $8.9 million, which was offset by a modest year-over-year decline in international revenues.

Our non-GAAP gross margin in the fourth quarter was 85% versus 87% in the same quarter in 2018, which reflects largely consistent glaucoma gross margins, and the inclusion of Avedro results in our fourth quarter of 2019. Non-GAAP SG&A expenses in the fourth quarter rose 24% to 38 million versus $30.6 million in the year ago quarter.

SG&A expenses grew approximately 8% year-over-year, excluding the impact of Avedro, which was approximately $5 million on a non-gap basis in the fourth quarter of 2019. R&D expenses rose 55% in the fourth quarter to $20 million versus $13 million in the same year ago.

R&D expenses grew approximately 42% year-over-year excluding the impact of Avedro, which was approximately $1.5 million in the fourth quarter of 2019. Beyond Avedro, the increased spending reflects the direct costs associated with the iDose clinical trial as enrollment continues to increase.

Our expanding development programs across glaucoma, corneal health and retina, and the cost of additional personnel as we expand our pharmaceutical R&D capabilities.

We finished the fourth quarter with a non-GAAP net loss of $2.4 million or $0.06 per diluted share compared to non-GAAP net income of $3.3 million or $0.08 per diluted share in the fourth quarter of 2018.

GAAP net income was $36.6 million or$0.84 per diluted share for the fourth quarter of 2019 compared with GAAP net income of $1.8 million or $0.04 per diluted share in the fourth quarter of 2018. The adjustments between GAAP and non-GAAP net income are outlined and quantified in our earnings press release issued today.

These adjustments are primarily the Avedro acquisition related accounting, integration costs and a one-time tax benefit as well as our ERP integration costs, patent litigation expenses, and in process R&D charges.

As of December 31, 2019 we had cash, cash equivalents, short term investments and restricted cash of $183.3 million compared to $161.8 million at the end of the third quarter 2019 and $149.3 million at the end of 2018. As Tom referenced earlier, we are introducing our 2020 net sales guidance of $290 million to $300 million.

This guidance outlook takes into account the continued expansion of our new corneal health franchise. Our U.S. glaucoma new doctor training, and overall market growth expectations, the full year impact of the competitive landscape dynamics, the continued growth of our glaucoma franchise internationally, and the impact of our integration activities.

We currently expect Q1 revenues to account for roughly 20% to 21% of full year 2020 sales, which reflects the normal procedure seasonality, the impact of glaucoma promotional activities in the latter part of 2019 and the expected near-term impact from our integration activities across the U.S. across the U.S. glaucoma and corneal health franchises.

We anticipate 2020 non-GAAP gross margins of 83% to 84% reflecting the growing contribution from corneal health and our international glaucoma business.

We also expect 2020 non-GAAP operating expenses of approximately $300 million, which reflects the normal procedure seasonality of Avedro, our growing global infrastructure and expanding R&D programs across glaucoma, corneal health and retina. Finally, we expect capital expenditures of approximately $35 million over the course of 2020.

These expenditures are primarily non-recurring investments associated with expansion and consolidation of our facilities. And with that, I'll now turn things back to Tom for a few years..

Alight. Thanks, Joe. Our strategic vision for glucose is now clearly in view as we leverage our strong foundation and our core competencies to build disruptive franchises in glaucoma, cornea health and retina franchises.

We are focused on near-term execution and excited about a long-term future, where in just the next two years we expect to have four major new product introductions with PreserFlo, iStent infinite, Epi-On and iDose TR.

Beyond that we have a fulsome portfolio of pipeline opportunities with iStent SA, iDose TREX, iDose Rock, PiXL, Dry Eye Therapy, retinal pharmaceuticals and the IOP Sensor.

We are confident these opportunities should allow us to become a formidable comprehensive eye care company uniquely positioned to deliver sustainable long-term growth and create meaningful shareholder value for years to come. So with that, I'll open the call to questions.

Operator?.

[Operator Instructions] And your first question comes from the line of Robbie Marcus with JPMorgan..

Hi. This is actually Allen on for Robbie. I wanted to start-off with the U.S. mixed market.

When we look at your performance this quarter, I don't think you guys broke it out on the call or in the press release, but could you give some color on how fast the market grew? Did it maintain that kind of teen’s rate that we've seen so far this year? And as we look out to 2020, obviously there's dynamics with competition, but how should we think about market growth..

Sure. Thanks Alan. It's Joe. I'll start-off with that. In the fourth quarter, our U.S. revenues were just shy of $48 million, which was approximately 5% growth year-over-year really all driven by volume.

Above that to the part of your question was, what was sort of happening in the market and the market in the fourth quarter, our best estimates are that continued to grow as we expected in the mid-teens and really for the full year as we look back in 2019, we really saw mid-teens market growth.

As we think about 2020 and look at our operational plans around new doctor training and same store sales initiatives. The current expectation is for market growth of double-digits to low-teens.

And that's really driven as we've talked about in the past by a combination of, of new doctor training, which we expect this year to be somewhere north of 500 new doctors that we would add to the roster of MIGS trained surgeons? And same store sales, which we continue to expect.

We'll expand the overall market on the heels of iStent inject, but perhaps not quite at the same rate we saw in 2019 where our reps were very focused internally at existing accounts..

Got it. So I think we were expecting a pre-market deceleration relative to our expectations, at least it looks like it was a little not market deceleration but competitive disruption in the corridor. It looks like it was a little bit more severe than we were like modeling personally.

As we look to the kind of the growth in 2020, should we expect like kind of if the market's growing like low teens, will you guys be in that similar mid-single digits range? And then how do we think about growth like beyond 2020.

Do we see you getting back to market growth and how do you really start competing against the kind of aggressive efforts being made by your competitors?.

Sure. Again, this is Joe. I'll start, and Chris may want to comment on this as well. Implicit in our guidance for the year of $290 million to $300 million is a couple things and you focused on the U.S. market, but I'll touch on the sort of full picture.

Our expectation there is that, that will be high-teens growth for both the corneal health and international glaucoma franchises and low-single-digit to mid-single-digit growth for the U.S. glaucoma business. We obviously unpack the underlying drivers in each of those in additional questions.

But as we think about then more broadly going forward, I think that low-single-digit to mid-single-digit combo cataract growth is probably the appropriate way to think about that part of our franchise.

Of course as Tom commented on in the prepared remarks, we expect on top of that as we move into the standalone markets both with the PreserFlo MicroShunt, iStent infinite, iDose and beyond that we can drive growth beyond that in the broader franchise. But for combo cataract, I think this is an appropriate way to think about things going forward..

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

Hey guys, thanks for taking the question. Joe, one on the guidance and one on Avedro. So on the Q1 guidance if I'm doing the math right, it looks like on a pro forma basis, you're guiding to slightly down slightly year-over-year on a pro forma basis again. So why is that and kind of what gets better.

It looks like you're, you know, guiding to about 6% to 10% pro forma for the full year? And I had a follow up..

Sure. Hi. Larry, its Joe. So as you know when we talk about the sort of year in the quarterly cadence we've often referenced, the cataracts seasonality, which we've talked about a lot, right? 22% in the first quarter, 25% and Q2 and Q3 and 28% in Q4.

When you think about the corneal health franchise, clearly it's still early in that life cycle to draw definitive conclusions, but, but what I can say is our expectation is that Q1 is to certainly the lightest of those quarters is from a seasonality perspective.

Given the fact that you're treating younger patients who at least with the off procedure we expect to be treated a little bit more in the summer months and then of course with reimbursement dynamics towards the end of the year. So from that is a starting basis point, Larry.

And in getting to the 20 to 21% that I talked about in the prepared remarks for the first quarter, there's a handful of things there, I'll touch on it at a high level and can go from there. Typical seasonality there is, I referenced it in the prepared remarks.

There is some impact from integration activities as we bring the sales organizations together, we make the adjustments we expected to make in the corneal health organization as well as the overall management of the broader commercial organization.

There are some customer oriented programs, if you will in corneal health that you time reference that are designed really to, to lower barriers of adoption for in the corneal health business as well as make sure that for those affected by the J-Code, there's a variety of initiatives there to make sure that they're in a good position going forward.

And then, finally I would say the combination of the domestic glaucoma competition dynamics and really some promotional activities that we had in the latter part of 2019. You put all that together and that's what gets us to that. That’s why deviation from the typical 22% first quarter to something that looks more like 20%, 21%..

Joe, that's helpful. Just for my follow-up. Tom mentioned some growing pains with the J-Code. So we've also heard about some variability in the payment and reimbursement for photracks. It sounds like, maybe you would agree with that. How are you addressing that? And do you guys have plans to pursue a Category 1 code for 0402T.

Thanks for taking the questions guys..

Hey Larry its Chris. Whenever you have a J-Code, there's always going to be some growing pains associated with that. We feel really good about our approach to it. In 2020, we now have a market access team; it’s twice as big as what Avedro had in 2019. These aren't unusual challenges to be faced with.

In fact, an organization early in 2012 and 2013 we faced similar issues like that, but J-Codes are unique. We put together a number of programs to help address it, to make them more customer friendly. And we're hopeful that we will get these through the system quicker with the additional manpower and programs that we put in place.

And while that's been an impediment a bit to the growth in 2019 we're hoping to resolve that in 2020..

And I'll take the question on the Category III codes 0402T we were talking about Larry and just tell you that we're actually really quite pleased with what we're seeing from the commercial payers.

As we've said before and Avedro said previously, we're seeing in the range of $2,000 or so professional fees which are being fairly metered out for, for this procedure.

The current Category III code continues as you know in the 2021 and I think we'll take a similar position here like we did with MIGS where we're able to extend that favorable code for another five. I think that'll put us in a good position for customers, a good position to be able to reap a fair professional renumeration for this procedure..

Thank you for taking the questions..

You're welcome..

Your next question comes from the line of Matthew O'Brien with Piper Sandler..

Good afternoon. Thanks for taking the questions. Just – again on the guidance side, just given the number coming in, I think lower than most of us were expecting, especially on the U.S. glaucoma side of things, just the dynamics that are going on within that space now, I think you have a couple of pretty notable competitors there.

Just – with all the investments they are doing, all the new surgeries are expected to add. I'm surprised to hear that it's so low.

So can you just hear that the outlook is so low as far as the growth rate goes? So can you just talk about what's going on in that category as far as losing clinicians or just the level of trialing that you're seeing? Are you seeing a lot more trialing? They do vary to other offerings or finally coming back to you guys and you're just expecting a fair, fair amount of that this year, maybe next year.

And then hopefully get back closer to – more like market rates a couple of years from now?.

Hey Matt, this is Chris and I hope we do get back to those rates. What we're seeing is a more fulsome competitor who's more fully staffed in terms of the sales organization, who's continuing to do a fair amount of trying and trialing, which includes free product or heavily discounted product.

We also are seeing more of activity from the tissue destructive procedures more specifically the omni-procedure and the KDD. These are primarily driven by economics for the surgeon and given the cataract reimbursement decline, this becomes even more significant.

I would say that despite the increase in trialing and trying of the product that the activity and the pick-up business on the Ivantis side is in line with what we expected. I would say on the tissue destructive side of things it was greater than we anticipated. And again, I think it's primarily being driven by economics..

Okay. Chris, sorry to push a little bit here, but I think the pressure reduction that you are seeing with omni – with Ivantis are pretty meaningful.

I know there are harder procedures to do versus inject, but is there a way to combat that for you guys? Because again, the press reductions we've seen in some of the clinical studies for those products are pretty getting a little bit better than inject.

So is there a way for you guys to potentially I don't know if it's a sensor perspective or something along those lines start to mitigate some of those pressures going forward..

I'm going to start with the Ivantis and the Hydrus product. The pressure reductions are very similar, there's only one-study out there that's a company sponsored study that would claim otherwise. But when you look at the pivotal trial the pressure reductions are very similar and then the safety profile for us to interject is superior.

And we believe that the ease of use and the elegance of the procedure is Superior. So while there is trying and trialing out there in the long run, we feel that we will prevail. As it relates to omni that is a procedure that's typically done more moderate late stage.

Those pressure reductions may be transient in nature and may be more significant upfront, but over the long run I don't see it that way. And it's also as I mentioned, tissue destructive. It's not in our minds a good long-term solution and again, I think its being primarily driven the utilization by the economics of the procedure..

Okay. I'll leave it with that. Thank you..

Thanks, Matt..

Thanks, Matt..

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

Well, thanks for taking the question.

Can you hear me okay?.

Yes. Hi, Bob..

Great. Joe, I just wanted to make sure I heard some of the numbers right. So for the fourth quarter the U.S. MIGS business was up about 5%.

Is that correct?.

That's correct..

Okay. And then you're guiding too for that same business in 2020, low-to-mid single digits for the U.S.

MIGS business?.

That's correct..

Okay. And then since this was kind of the first quarter where we got a cleaner look at the U.S. MIGS business given the anniversary of Alcon’s issues. I was wondering, I'm just curious that 5% number in the fourth quarter. Roughly what was the growth rate of your business in U.S.

MIGS in Q3 if you have that off-hand? And when you kind of on an apples-to-apples basis with that 5% if that's a possible number to get?.

Yes. Well I don't have that number off-hand. You're sort of asking me to unpack between what was the – I'll call it organic growth relative to the share recapture of CyPass if I understand the question right? Bob..

Yes. Yes..

I think it's fair to say, so if you just take the competitive dynamics over the course of the year, which we've talked about on every quarter and sort of that the pick-up whether it’s in the context of Ivanti's commercial organization and the trialing and sort of that initial launch that they had or the tissue destructive dynamics that Chris was just alluding to.

That was obviously over the course of the year, slowly picking-up steam as both of those organizations increased their size and some of what they're doing. So I think it's inherent underneath the reported results that you probably saw a somewhat linear step down and kind of the organic growth that you're asking about, Bob..

Okay.

And then last question, Joe, and again as you might not have this, but I'm just curious for the fourth quarter, in the United States do you have a sense as to what share of the market those other two competitors that you've mentioned might have or what your share is in the fourth quarter of that us MIGS market?.

Yeah, I mean we, we obviously have all of our internal analyses that we run and look at, but it's not something that we've comment on publicly, Bob and there is a fair amount of noise in that in any given period given the lack of publicly available information on those competitors, both of them or all of them being privately held..

Okay. That's all I have. Thank you very much. .

Thanks, Bob..

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

Thanks. Good afternoon guys. And sort of a similar line of questioning I guess, but Joe, that the 2020 market growth, call it 10% to 13% that you sort of alluded to is below the mid-teens that I think you called out last quarter. So why that revised rate of market growth, considering you guys are the ones sort of driving it.

I'm just trying to figure it out, is training going slower or new docs coming into the fold a little bit slower than you thought? Maybe if you can just elaborate there..

Sure. Jon, it's a good question. I'll start off here and if Chris wants to add something, he can at the end. So when we – in the time since we were on the third quarter call, I guess in early November, a couple of things. First, actually our fourth quarter training certifications, we were quite pleased with.

We definitely saw kind of rebound after a pretty anemic period that we had hoped and expected in the fourth quarter.

But as we work together, the commercial organization is laying out their plans for 2020 over the course of, you know, November, December, January and looking forward that's where we landed training plans, that were probably a little bit less than what we had originally hoped.

And that is, I mentioned in the prepare, in one of the other questions a little north of 500 that we'd expect to train in 2020.

And what really drives that is an expectation and we'll see how it emerges, but an expectation that as you get in this part of the training curve, if you will, that it will take a little bit more time to train your average doc.

And as we've all known, on average, the productivity or benefit to Glaukos from the average training with doctor is a little bit less, right. Not a market shift, but over time we've seen this and we continue to expect it, that there'll be a little bit of a decline there.

So, I think it really has more to do with us getting to the place as a part of our 2020 planning where we were much more laser focused obviously on what operationally we think we can achieve in terms of new doctor training..

Yes. And Jon, I'll add to that, we are the primary drivers of the growth. And so when you add to that what Joe just talked about with the types of doctors, now they're in the training panel, it's some of the activities that we have to do in terms of addressing competition.

I think that's a real good understanding of why we landed on the numbers we're at..

Okay.

And just a quick follow-up to that same question, 500 on a base of 1, are you willing to give us an approximate number of where you are before you train the additional 500 sort of where you exited 2019?.

Yes, I mean I appreciate the question, Jon. Obviously we stopped giving that level of granularity some time ago. The intent of telling you the 500 is at least as orient investors relative to what we have seen at kind of the highs, right.

I mean, I think back in 2016, 2017 we were training docs at a clip of 700 plus a year and we wanted to give a sense of the orientation of that for 2020 relative to those time periods. .

Okay. So very helpful.

And then the last one is just on the competitor and you've called them out by nationwide, I think the initial thought Tom or Chris was, Hey, you know, the potential traction for those guys as largely confined to glaucoma specialist is trickier procedure that high volume cataract surgeons are comprehensive guys don't want to take on that additional risk.

So maybe you can talk about what you're seeing in the field. Is it still largely confined to that glaucoma specialist channel or have you seen it leak into the other areas? Thanks for your time..

Yes. So I would say as a generalization, they've had much more success with the glaucoma community. Had they had some success with the comprehensive ophthalmologist or there's been some cases of that.

And I expect there will be but in large part the majority of their success has been in the glaucoma community, because they are more prone to dealing with the challenges that that device presents and it's more acceptable for them to take the time to deal with that.

So it's a generalization, but yes, they're still very much focused on the glaucoma community..

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

Good afternoon and appreciate you for taking the questions. Maybe just a little bit different tact to start, then. I have one quick follow-up and you look at the guidance, they're kind of in the mid-teens for the Avedro portfolio and just kind of looking at where that business exited the fourth quarter.

Can you speak broadly to what your expectations are for capital versus volume? And maybe any changes as it pertains to the pricing of that offering for Texas specifically in a bundle back into these new practices as you continue to scale. And then I've got a quick follow up..

Sure. Thanks Chris. It's Joe. I'll start off. You know implicit in the guidance, as I've mentioned earlier, for corneal health, franchise expectations of high-teens growth, clearly a step down from what was experienced in the course of 2019 and a handful of things that are driving that all of which quite frankly from our perspective were expected.

As you referenced, we do expect to lower the barriers for adoption, right. And part of that is something we've been alluding to, since really the outset of announcing the transaction and that relates to the capital equipment side of the business.

And we do intend to pursue operating lease options and other things to really drive down those barriers for the adoption. If you look back on 2019, a little bit shy of 10% of Avedro’s revenues on the full year were represented by capital equipment. So clearly that's a component of headwind going into the year.

The other pieces that we've alluded to and Chris may want to expand on here, relate to more of the integration side of what we're doing, again, expected, there's an integration component here, certainly in the first quarter, maybe in the first half.

And then some of the programs that we're putting in place to make sure that these customers are in the right place with respect to the J-code dynamics that have been playing out.

And Chris, if you want to add anything?.

Yes.

Hey, Chris, how are you doing?.

Great..

So Joe, really handled our philosophy on the capital and I'm making it an impediment to the sale. In terms of the integration of the business and moving forward, we just came off of our sales meeting a couple of weeks ago.

There's been a lot of shall I say, transient disruption in terms of who the corneal health specialists are reporting to, that's all changed, they're moving to more of a regional commercial management program. The glaucoma folks, they've been fully trained, a large majority of the sales meeting was spent on cross-training those folks.

And we are really putting our model into place where the Glaukos representatives are now glaucoma representatives will kind of serve as the hunters, they will be out there prospecting, calling on people, getting them interested in the business.

In the simplest of terms, the cornea specialists will be focused more on same store sales growth, integration, reducing the barriers to utilization, working with the ODs, referral patterns, et cetera, so in short same store sales growth. So that'll take, as Joe mentioned some time to get that completely wired up.

I think like we've done in the past, we've done a good job from in regards to execution and we'll continue to do that, but we expect some minor disruption in Q1 and potentially into Q2..

I appreciate the additional color. And then just quickly for my follow-up, when you think about the domestic MIGS guidance or what's implied for domestic MIGS growth in the coming year 2020.

Can you speak to us about your thoughts on pricing, historically you've benefited from price increases as we started each year for the original iStent and then obviously with the inject, with you are being at a competitive disadvantage in terms of reimbursement versus omni and a few of the more aggressive approaches that are out there and more trialing from Ivantis.

Is the slower growth predicated upon a sheer loss of volume or is it also assuming some degradation in pricing as well? Thank you..

Thanks Chris. I think from a numerical perspective we saw relatively stable pricing in the fourth quarter, a very modest headwind related to some of the promotional activities, et cetera. As we think about 2020, expectations there are for the continuation of relatively stable pricing environment.

So not really a significant benefit and certainly not really a significant detriment to the expectations. It's really all related to volumes and volume growth..

And Chris, to your point yet, there are pricing pressures out there and we'll have to look at each one of these situations as standalone items. But our attention is to continue to be a premium priced product because we are a premium product. So that's our stance as we sit here today..

Thank you..

Your next question comes from the line of Ryan Zimmerman with BTIG..

All right, thank you. A couple of questions for me. Just want to ask one, Tom, maybe one in iDose, so I think we're expecting matter process are kind of midway through this year, maybe a little sooner.

I'm just curious kind of what feedback you've had – you've seen from physicians around that product and kind of how it's informing your view on iDose and it's just a subtlety, I think I heard you say it was more closer to FY 2022, you previously said FY21 and FY22.

So just what changed on that slight pushback there and then I have a couple of other follow-ups. Thank you..

Yes, I'd be happy to do, I don't think anything's changed. We've said consistently for many years that we were looking at either a late 2020, 2021, 2022 and have basically, we'll be adhering to our base case for approval, right as we continue to move forward with the iDose clinical trials. So nothing's changed there.

What I would tell you is in the matter process[ph] are, have been consistent all along. I think it's a good product. I think the drawbacks of the product is it has to be injected in the clinical trials that they've done.

It's designed to last about four months, so they've done injections every four months to be able to achieve the reductions and pressure that they've seen.

And that's largely because it's a biorotable and as I've talked about before biorotables only allow a certain amount of API that can be placed into the matrix in order to achieve the type of zero order elution that they're seeking and typically that's about 20% to 25% of the drug. So I think there's a significant drawback.

What I do like about the product is that it appears that it does lower pressure, that validates the intercameral use of a prostoglandin going behind the cornea with a very low elution rate, be able to achieve really a phenomenal reduction in interocular pressure.

What I love about the iDose is, we've said before and as I've alluded to as of a couple of calls ago, I continue to look at the late breaking data. The data that I did talk about openly was at two years, at two years it looked like there was a still a very marked reduction in interocular pressure and reduction in drug burden.

I think these will be highly important when we do launch the product into the marketplace when we start to see these kinds of sustained interocular pressure reductions and relief of drug burden with a single injection. And that's why we intend to present this to the marketplace.

So I remain intensely and highly excited about the launch of the impending launch of the iDose product. And then, we talked about the iDose TREX, if we're able to take the same form factor and be able to increase twice the amount of API in that form factor with the same diminimous minimally invasive injection.

I think that just portends a really a breakthrough product and a game changing and paradigm changing product for glaucoma. How will I inform my view? Well, there'll be some uptake that I'll see and how Allergan goes with the adoption.

And I think what it will help too is, how Allergan prices, I've been asked several times what our approach to pricing is going to be.

We continued to do a mark-off transition probability analysis, then quality of life analysis and other things you'd expect us to do in sophisticated pharmacoeconomic programs, but a lot of what we'll see, I will be interested to see how Allergan prices and how they justify their pricing in rationale, which will then help inform us of how we go forward with our product in the marketplace..

And can we see rescue rates from the iDose data at some point? And if so, when?.

Yes, so what I've said all along and been very consistent is that, we've given obviously very fulsome interim cohort data, which shows the promise of the device.

And obviously, I’ve commented on two year late breaking results, what I do plan to do, is to be able to show when we have Phase 3 data, we'll have a ability to show the three month data, which will be the primary basis for approval.

We'll be able to show the one year data, which will show then a combined approach out to one year in terms of safety and efficacy. And then as we extend that data over time, I'll be happy to share that with the community.

I haven't totally closed on the option of presenting Phase 2b data at some point, but I continue to like our position to husband that, I think it gives us more benefits than risks for the institutional investors that I'm representing by not informing the competitor many months prior to approval on how they might counter promote against us.

And so while it's somewhat frustrating sometimes for I guess the analyst who'd like to see the data, I think on benefit to risk calculus for us, I think it really implores me to husband that data as long as I can before I give a – divulge more on the Phase 2b data..

Okay, fair enough. And then MicroShunt, I think originally we’re expecting kind of late 2020 as well, potentially the 2021. So now you are thinking about FY 2021, just some perspective, maybe Joe on the contribution from MicroShunt, size of that opportunity.

And how fast can you get it in the hands of your sales force as we think about it in 2021?.

Sure. I'll start off. And then if Chris wants to add or someone want to add, they can. Obviously the timing with respect to the MicroShunt remains largely in our partner Santen’s hands. Their most recent commentary is that we should be expecting filing, I think they said by the end of their fiscal year, which is here in March.

So the filing should be coming soon. The timing of the FDA's review there obviously can be somewhat variable instance, what we've said around late 2020 or early 2021 timing. From a contribution perspective, I mean, it's a little too early for us to get too granular on that.

I think the reality is we think about that, it's a category that's well understood but – and we think it's a great product to serve the needs of that category. But at the same time, we have to get out and obviously do the blocking and tackling of training surgeons and getting them going.

And so those will all factor into our thinking ultimately when we give a view on the numbers for 2021, but it's a little too early for that..

Okay. Thank you..

And there are no further questions at this time. I will now turn the call back to Glaukos for any closing remarks. .

Okay. Well, thank you all for your time and attention today and for your continued interest in Glaukos. Good bye and have a good day. .

Well, ladies and gentlemen, this concludes today's conference call. Thank you for your participating. You may now disconnect..