Q2 2022 Glaukos Corp Earnings Call
Copies of the Companys press release, and quarterly summary document both issued after the market closed today are available at Www Dot glass coast Dot com.
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This call is being recorded and an archived replay will be available online in the Investor Relations section at Www Dot glaucoma Dot com.
I will now turn the call over to Chris Lewis, Vice President of Investor Relations and corporate Affairs. Please go ahead.
Okay.
Thank you and good afternoon, joining me today are glad because chairman and CEO , Tom Burns, President and CEO , Joe Gilliam and CFO Alex Thurman.
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While there 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 product pipeline technologies U S and international commercialization integration and market development efforts efficacy of our current and future products competitive market position regulatory strategies and <unk>.
<unk> for our products financial condition and results of operations as well as the expected impact of the COVID-19 pandemic on our business and 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, it might may cause our actual results to differ materially from those expressed or implied by forward looking.
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Directly comparable GAAP financial measure.
With that I will turn the call over to glaucoma, Chairman and CEO Tom Burns.
Thank you Chris good afternoon, and thanks, Thanks to everyone for joining us today.
<unk> reported second quarter net sales of approximately $72 7 million down 5% year over year on a constant currency basis, but up 9% sequentially versus the first quarter on a constant currency basis.
As a reminder, the second quarter represents a challenging year over year comparable for many in the med tech industry, but in particular for glaucoma.
We are raising our 2022 net sales guidance range to $2 75 million to $280 million versus $270 million to $2 $75 million previously.
Given our solid execution globally better than expected second quarter results.
Latest forward outlook.
From a commercial perspective, we continue to be pleased with the execution of our strategies and the resiliency of our U S combo cataract franchise in the face of the reimbursement headwinds thus far in 2022 with.
With our glaucoma U S glaucoma franchise, delivering strong sequential growth of 13%.
During the latter part of the first quarter, we launched our I access device a novel instrument with features that allow customers to perform goniotomy procedure.
Surgeon adoption and utilization of eye access continues to grow and market feedback remains positive.
During the latter part of the second quarter, we also commenced a niche.
Actual commercial launch activities for I Prime our innovative new visco elastic delivery device.
While we remain in the very early stages of <unk> controlled launch this platform adds to our expanding portfolio of unique solutions designed to grow and improve treatment options for our surgeon customers and patients.
Our international Glaucoma franchise once again delivered quarterly record sales despite significant foreign exchange headwinds as we execute our strategies to drive deeper penetration and broader adoption of makes around the globe.
Within our corneal health franchise, we continue to focus on access for keratoconus patients suffering from this rare disease. We are investing in additional commercial payer market access coverage and response to sporadic issues that have emerged in 2022.
On the development front, we continue to advance our pipeline.
Following the recent clearances and commercial launches of access and I Prime we're delighted to announce today that we have received FDA five 10-K clearance for Istent infinite our novel <unk> injectable system designed to provide.
Foundational $24 seven IOP control for glaucoma patients.
This FDA clearance represents a significant milestone for glaucoma and the migs market as the first ever micro invasive implantable device indicated for use as a standalone glaucoma treatments.
Supported by strong pivotal data highlighting favorable safety and effectiveness. We believe istent infinite may provide ophthalmic surgeons with a compelling new treatment alternative in a standalone procedure for patients with open angle glaucoma uncontrolled by prior surgical and medical therapy.
We are preparing to commence initial commercial launch activities for this promising technology later this year.
Our clinical and regulatory teams also remain hard at work advancing pre submission activities for Idose TR and <unk> respectively.
And we expect to be in a position to announce top line phase III data for Idose TR later this year.
In terms of our earlier stage pipeline, we are happy to announce we completed patient enrollment in our eye Lucian phase II clinical trial for dry eye disease during the second quarter.
Also expect to complete patient enrollment for our <unk> phase III clinical trial for presbyopia during the third quarter and we anticipate initial data readouts for each of these trials by early 2023.
We are now in the midst of several new product launches and are planning for a robust cadence of new droplet platform and product introductions over the coming years.
The potential to fundamentally transform glock cloud costs overtime and meaningfully advance the standard of care and improve outcomes for patients.
Suffering from sight threatening diseases.
As such we are continuing to invest in glaucoma to scale, our team and to advance our mission to transform vision.
We are excited about our prospects and confident in our ability to execute our plans in the years to come.
So with that I'll open the call to questions operator.
Thank you at this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad will pause just a moment to compile the Q&A roster.
And we will take our first question from Andrew Brockman at William Blair.
Hi, guys. Good afternoon, and thanks for taking the question.
Maybe just to start here on Idose.
I appreciate all the commentary that you provided in your short remarks, Tom, but I guess as we sort of sit here mid September 13 months. After the last patient enrolled that last arm of the trial can you just sort of level set us on how youre thinking about that pipeline opportunity and your confidence level that that will be successful and I guess as a follow up there can you just talk about the.
Scorecard that youre going to be looking at to evaluate the success beyond the type of top line data anything in particular that youll be looking at in the study.
Yeah happy to take your question. So it's important to review just how successful. This product has been if we look and kind of scrutinize what happened in the phase <unk> data results that we recently announced our earlier this year, we found that 70% of patients who are well controlled on idose.
At the same or fewer topical IOP lowering medicine 36 months and many of these patients were on two or three minutes with pre screening. The average there. The mean IOP reduction at 36 months for the Idose group in these various scenarios range from eight three to $8 five millimeters of Mercury So really.
Pain reductions in inter ocular pressure. So we were in variably pleased that and buy any analysis. The idose TR performed similarly to Timolol 36 months in terms of mean up fee reductions, but with far fewer topical medications.
Those were the kind of the topline efficacy results I think it's important too to then say, okay, well what happened on the safety side and the product was extremely well tolerated. We found no ocular hyperemia and found no period per overall fat atrophy.
And importantly, we saw really no clinically significant corneal endothelial cell loss versus Timolol control.
And only one instance of Hypochromia, our Iris color change and so these are significantly powerful safety factors for this device and so when we look at what the appetite is occurring in the marketplace. There has always been a substantial kind of underlying appetite for sustained released medication that could.
By 2047 control of glaucoma, because noncompliance is so ubiquitous and such a ramp and cause of the underlying progression of glaucoma disease.
This product represents an incredibly different paradigm change to be able to treat the side of a simple injection as a standalone procedure I expect that it will be will be used to be able to overcome issues of noncompliance and glaucoma issues of allergy with up with the disease.
<unk> issues of Pacer.
Patients who have underlying ocular surface disease. So you don't have to continue to pour topical agents that have toxic preservative.
In the formulation on the surface of the eye. There are a number of different places that we think is practical to use and not and importantly, we do believe that the use of idose could become kind of a nice.
Complementary product for the use in combination cataract for those patients who have comorbid glaucoma.
So it's exciting I think you already see what's happened with Allergan they've introduced their <unk> products you can see the strong appetite in the uptake of that product and the product is a novel innovative product, but it does have some flaws and as we know the one of the conditions of the label.
Was restricted to a onetime use due to the relatively high rates of corneal endothelial cell loss.
I I'm hopeful and do not expect to see that because we track the corneal endothelial cell loss in Idaho for two years as part of the phase <unk> clinical trial and again, we saw no clinically significant corneal endothelial cell loss.
In addition, we're doing a cohort of patients that we'll look at exchanging the idose and fits you as part of the once they've implanted the product as part of the continent.
Our clinical trial and we're following a cohort of patients and we expect that data to be prepared and submitted as part of our NDA, which if favorable will give us the right to be able to exchange and move forward in and use this product sequentially over a longer period of time once the initial products has been depleted.
Medication.
So many of you are starting to do your channel checks, you're finding a strong appetite youre fighting the excitement in the ranks.
We expect to be able to enter with that tailwind behind us.
Allergan.
Yeah, it's a good mark a marketer.
As dawn and set a good predicate for us introducing their de risked a product with less primarily designed to last for months in the eye and it reached over 2000 dollar J code Asps.
When I see that that gives me a strong back foot a backbone for introducing this product.
Fair and productive right from the business. So we're excited I think the important thing you heard in my opening comments as Ive given direction from the beginning that we would publish data either by year end or by early next year and I'm moving that up to by year end and hopeful to get some data in the hands of investors in the App.
Analyst up in a very short period of time.
Very very helpful. Thanks, Rob Thanks for all that color maybe.
Maybe if I could just switch to istent infinite quickly congrats on the approval there what can you tell us about some of the initial sort of commercialization efforts in market building on the efforts that you'll be putting out there and how should we be thinking about uptake later this year and into 'twenty. Three are in light of that proposed facility rate for 2020 three.
Sure Andrew It's Joe I'm happy to.
That obviously, we're we're excited about receiving the FDA clearance that Tom mentioned.
Yeah, another chance for us to pioneer the market with the first ever micro invasive implantable device for San Juan Standalone glaucoma treatment. So.
We're enthusiastic here about that launch as it relates to timing and any time you receive an approval you have a series of steps to finalize labels and.
Sterile approved inventory and training logistics in the form of launch plan. So we've been hard at work for the better part of a year preparing for this moment I would expect that for all intensive purposes.
Youll see soft launch activities as we kind of exited the third quarter and head into the fourth so that should give you a sense of that timing.
You referenced obviously the facility fee.
And and some of the proposed rules there and you know I think on that I'll, just say that while we have work to do we've been here before and we're already hard at work on that front.
Okay. Thanks, guys.
Well move next to Chris Cooley at Stephens.
Good afternoon, congrats on a great quarter and I. Appreciate you taking the questions just two for me if I may.
First just as a follow up to Andrew's questions. Tom I. Appreciate all the color you provided on the Idose, but I was hoping we could maybe get a little bit more granular on the reimbursement outlook and a pathway there.
Slide the rest to provides a product yet.
In the early stages, but you would think would have a longer duration of effect. When we think about the idose TR could you just kind of walk through that pathway for us and.
What do you think we could possibly envisioned when we think about reimbursement for the device.
And secondly, just thinking again here looking at this deck, which again I'll have to come in and Chris for it it's a great piece of work.
But as we look at that pipeline.
Increasingly this looks like a pharmaceutical company like much like the old Allergan and so I'm just kind of curious about the next level of investment to choose a proceeding to undertake you've already obviously built out the bench from an R&D perspective.
What do you start to need to bring on board from a sales and marketing.
Reimbursement kind of Glen Dev type aspect and when does that start to kick into the P&L. Thank you.
Okay.
Yes, Chris I'll be happy to take your questions. So the first question that you talked to me about with Idose and reimbursement. So as you know we've already I think.
Set the table by applying for.
A category III code with the Ama's CPT CPT Committee, we were successful in getting that code established.
That code then right now it's under current exclusion. So it doesn't be corrupted by people that would put data in there.
That category in the hospital and so what we'll do is we'll open it up.
With CMS just prior to commercial launch.
And so what we'll do much like we do with Istent infinite as we'll have two established and have the different macs crosswalk, the perioperative procedure or putting in a standalone device of Idose and crosswalk that to a to a like category one products to try to establish the highest professional.
Fee. So it's something that we've been quite proficient at in the past and we will continue to do so as we move forward with with the Idose in terms of looking forward for payments in the APC level and in the with the device. This will be assigned an APC at the time of approval.
Now I remember when we have this will be assigned a J code and so the J code will be a carve out for idose itself.
That product and that J code will take forward in the following way will apply for a miscellaneous J code at launch we will get that J code that miscellaneous code and then Hicks picks committees meet every quarter and so we'll look at formalizing and giving a formal J code at the.
The price points that we believe best serves the marketplace sub.
Subsequent to launch.
Key assignments will be much like happens with istent or Istent infinite will get an assignment, we'll see if we like it whether or not we need to to reengage with CMS or if we sit tight.
And remember that APC assignment will be then wholly owned by the facility because the idose will be carved out from that so it puts the facility in a nice position of able to to achieve profitability for doing these devices.
So that's a look.
I think I've answered your question fully both on the <unk>.
Professional fee side and on the facility side for Idose.
Again, the Arista has been set at a rate of about $2000.
Designed to last for four months I don't want to give any indication that we will we will price proportionately based upon length of therapy, but you can see that I have a lot of open field running in.
And being able to to establish a price point for Idose wood by the phase <unk> data appears to be lasting.
Many months.
And so to your second question you were talking about the pharmaceutical business I think you need to bifurcate. This approach into really two sections, one surgical pharmaceuticals.
Those I would list Idose Idose T Rex Iraq, if were successful bringing that forward.
Products like cross linking which really are a surgical pharmaceutical and those these are buy and bill pharmaceuticals that can be handled and established by our current sales force and this is where we really reap the reward of investing in our sales our sales force and using it to scale by adding additional product.
Both devices and surgical pharmaceuticals, when we get into the retail side of the pharmaceutical business. You know that's a very different animal. So when we look at our topical applications of transdermal approaches like our high elution, which would go through pharmacy and wholesale channels, that's where we'll need.
To establish a second.
Secondary sales force to be able to approach and market those products. We've had substantial experience in the past in doing so make no mistake. We are confident we will establish the best teams and launched much like we have on the surgical device and pharmaceutical side, but we will need to bifurcate and.
Separate sales forces to do that.
I think that that answers your question.
Thank you.
Okay.
Well move next to Larry Bagels signed at Wells Fargo.
Hi, This is Charles on for Larry Thanks for taking the question just.
Just a couple on prime.
First I got to ask about <unk>.
Looks like.
Can you help us he didn't get the device intensive and the rule. There do you think thats possible that could change in the final rule and then second maybe just if you could talk a little bit about how long you might think that the initial controlled launch for I probably might last thank you.
Sure. Charles This is this is Joe.
I think like most things on reimbursement, we would hesitate to speculate it clearly.
On the table.
Up in throughput in the proposed rule through to the final rule, so entirely possible that that could happen as a part of of 66 to $1 74.
You know I think as it relates to the launch as we mentioned we've we've commenced initial.
Initial.
Very early commercial launch activities in the in the quarter with our customers.
And we're going to continue down that path I don't think it typically in these situations. There is a single moment in time, where it changes dramatically. It continues to sort of expand one wave at a time until we feel like our customers are proficient with with this new new option.
Thank you.
We'll go next to Ryan Zimmerman of <unk>.
Thanks for taking my questions congrats on the quarter guys.
Tom I wanted to ask you a couple of questions and maybe this one is more for Joe but I also have some high level questions. So first on guidance. You know you think about what you've done this year, thus far kind of about 50 plus percent or so for the first half of the year.
And we look at guidance that you raised $5 million at the midpoint, but if you go back to 2019 and the seasonality that we've seen particularly in the fourth quarter.
It suggests a similar run rate as what we saw in the first half of the year.
In terms of your guidance and so you know why doesn't.
It got a little bit higher.
For the remainder of the year, particularly in the fourth quarter, just given where you have guidance today, hopefully that was clear Jeff.
No.
As Ryan I think it's a totally fair question and one certainly that would anticipate given the analytics that you just I think articulated well you know if you.
Maybe first and foremost I'm not so sure that in the situation with all the various things going on in the marketplace.
Probably wanted otherwise that I would look at the typical seasonality pattern and say that is a good guidepost for guideline for how to think about our year.
In particular, and while I certainly follow the math I think some things that you have to think about in the second half.
As we evolve here and a foreign exchange is certainly emerged as a pretty material.
Material headwind not just for US I think for everyone. So and you think about how that transpired over the course of the first quarter and then really.
Strengthened as a headwind in the second quarter and certainly at the end of the second quarter entering into the third you have to factor that in when you are trying to think about these things. The second thing I would say that that you know when you think about second half versus first half is that you've heard us say many times. We think we have a ton of respect for Alcon, we think they're a formidable competitor and.
And we expect that they'll continue to get their sea legs as the year progresses, both here in the U S. But also internationally so.
And that the factors or things that you've heard us talk about before right the ongoing impact of the CMS Profi cut.
Account staffing the types of things you probably heard from other companies as a part of this.
Earning season, some of the commercial payer volatility dynamics in the corneal health side.
You kind of put all that together and I guess the way we looked at this coming into the call here is that we're pretty pleased to be able to raise the full year guidance again, right and to be able to pass through really the entirety and a little bit more of the beat we just had in the second quarter, given sort of all that macroeconomic and specific headwinds that we face.
Oh the <unk>.
Clearly a fair Joe I appreciate the commentary and then Tom for you I mean, we've seen so much reimbursement change in the space right. I mean, the start of this year with Wesco is around stem based treatments to now the proposed fees for canal based devices and I really would just.
I appreciate your view of where reimbursement where the reimbursement landscape shakes out how you think about the impact of all these moving components and glaucoma philosophy, given the multitude of devices that you now offer how you navigate.
That.
In such a.
Landscape that is in flux.
Well, it's a good question.
And it's something that I can assure you I think about almost daily.
As we look at the shifting wins a couple of things that are important is that some of the kind of transitions past right. So now we've moved into a category one.
A procedural code with combination cataract procedures, we know now where we stand we were really.
Pleased we were able to carve back what were some significant draconian cuts that happened last year, and we fought hard and I think valiantly and we're able to really claw back, particularly on the APC side and be able to preserve a really a fundamentally profitable.
Procedure.
For the for the providers to be able to to use the istent device and so that's an important.
Important whenever you create new markets, we have to go through these growing pains with these new codes and so we will do so with Istent infinite will spend the next six to nine months clearly going into each of the Mac and be able to try to convince them to crosswalk. This over to a like procedure that we feel appropriately represent the RV.
For the procedure. It is something that we believe we're good at.
It's something that takes a lot of time in muscle and patients and and there will be episodic setbacks in the process of doing this much like there had been as we built the migs marketplace.
We will see the same thing with Idose on the.
The professional fees side, although I think that once we settle on an istent infinite and I expect that to be more streamlined and efficient moving forward.
But that will be kind of a sideshow to the approach that we take with getting the J code for the device. The J code really are subject to our own procedural pharmacokinetics of what we think is a fair and position on pricing in the marketplace. What we think we can favorably represent and stand behind.
And once we do present that we will then get that through hick picks and get a formal J code.
Subject to review.
I would remind everybody as well with the T. Rex products that follows because the T. Rex has substantially more.
Hi, onboard approximately twice the amount the way that CMS works is they will pay.
By basically the micro Gram of the product that's resident in the in the can itself of the Idose device. So that gives us legs as we move forward on payments and and I would say consistency and predictability for investors as they think about that going forward. So this is something that when you build.
New marketplaces. These are the are the growing pains that you go through and that you take we're a leader we're the pioneer we're at the front end, we are creating this marketplace will create sustained marketplace for idose therapy, we're creating a new marketplace in keratoconus with cross link.
<unk> and its subsequent generations.
We become good at it.
It's difficult process.
But we're at it every day and we think the payoff is there and we're already seeing that pay off as we build value in this marketplace.
Thanks, Tom.
Sure Okay.
Well move next to Matt O'brien of Piper Sandler.
Okay.
Hey, this is Phil on for Matt can you hear me all right.
Yes.
Okay.
Hello.
Yes, Bill we can hear you well.
Alright, Thanks for taking my questions and congrats on the quarter for my first one on the dual procedure reimbursement dynamic what are you seeing in terms of that sustained power.
More specifically the Palmetto LCD recently came out with language surrounding goniotomy.
Stating that 65 to 820 should not be used in conjunction with other angles.
Ingalls surgery stance implants.
Even if the decision is minimal or incidental so like kind of what sustained power here of that dynamic going forward.
Thanks for the question Phil.
I think first of all it's an LTA non LCD its technical difference, but it's important.
I think anytime you have two separate devices, two separate company procedures and to to think codes.
Certain discretion on what they deemed medically reasonable necessary should should ultimately govern I think thats. The way most medicine is practiced and reimbursed throughout not just in ophthalmology.
On this one the Ao is assessed.
This quite thoroughly given the growing trend that for years has been.
Expanding here I mean, it's ultimately aside sight threatening progressive disease.
Where surgeons want to utilize multiple tools to optimize the clinical outcome for the patients so <unk>.
Looked at this they have come out both in March 2022, with their bulletins around the utilization of of Canal Atlassian combination with pension cataracts, and then more recently with their Goniotomy fact sheet that we think is quite clear. So ultimately our goal here is to provide surgeons with.
The best tool right that are minimally invasive to maximize their benefit to patients and hopefully grow the overall market, while doing so and as we navigate that well continue to sort of.
Work through things that pop up whether it's palmetto, where other areas on the behalf of our customers and patients.
Great. Thank you for that color and just a quick follow up here you know I assume some competitive trialing went on in the first half as surgeons become more aware of reimbursement changes and things of that nature. What are you seeing on that front.
Others leave Guac House, and then you know some come back after Trialing other products. Thank you.
Well I think anytime you have something.
The like of the changes that we saw in the CMS professional fee coming into the year youre going to have some disruption in market trends and I I'd say.
Sort of all of the above right you, you'll you see customers, who will try and trial other alternatives and come back recognizing that that stent based solutions provide the best long term therapy for their patients.
And you also see the same type of trying and Trialing as we launch our own products new products into the marketplace. So I think we're well positioned we've got a full portfolio of solutions for those physicians, who want to try other alternatives for their patients and will continue to navigate those dynamics as we move forward.
Awesome, Thanks for taking my questions and congrats again on the quarter.
Thanks Bill.
We'll take our next question from Tom Stephen at Stifel.
Great Hey, guys. Thanks for the questions. If I can start on Idose, sorry, if I missed this but as the year end 'twenty two NDA submission target.
Changed at all I think I think the commentary in the press release was altered a bit and.
And I guess, if so is there something specific informing that change that you can call out.
Just want to clarify the path forward and then second on Idose can you just talk a bit.
About site of service I guess, you know how should we think about whether or not this can move potentially beyond that.
Or.
Yeah.
Okay, Tom I'll be happy to take the latter question first.
And as we've said all along the Idose device today.
As a highly benign procedure that go through a very very small incision and so one of the things we've been actively approaching and working on for some time as being able to come up with an applicator that can be able to be able to go through potentially a small enough and decision.
Where you can keep the pressure in the eye and be able to not have what's called the hits and where the acreage in the workflow and you're able to complete the idose implantation with just a single single injectable procedure.
And if we are.
April to be able to execute and have that happened and we're making substantial progress that I do see the fact that this can be able to move and it's been our strategy from the beginning to offer a product that can be used either in the ASC.
<unk>.
Eventually in a minor in office suite, and I think we'll be able to get there with the idose product when.
When we do so we will have a couple of codes will have codes in place that pay for the idose device in the ASC, which I've described.
Previously and we will also have a.
Another code that will provide for the use of the Idose in office.
So to the extent that we are successful in creating this applicator and again, it's been our mission from the beginning we will be able to provide that now having said that right now I'm agnostic about where this product is used there are many surgeons that are telling me they want to stay and keep this in the ASC moving forward and so my hope and my.
Delivery would be that would be able to provide.
Options for surgeons overtime.
Hey, Tom and Joe on the first part of your question.
I don't think there was anything intended to be in our IR materials press release or otherwise that would have made news respected the timing of an Idaho submission we've been talking around year end for a while.
Actually the only thing that we said was the pre submission activities are ongoing what you would expect and probably the only news that debt in Tom's prepared remarks that we referenced was that that he is prepared to provide the idose data prior to year end, which was a little bit move forward from from some of the prior guidance that we'd given.
Got it so just kind of blocking and tackling in terms of the pre submission items Fridays nothing nothing specific to call out.
No.
I would say that in further Thomas if you take anything from my remarks, the fact that I've moved up from saying.
That we would have done by early next year and publish the data again restate that we'll be able to publish this data before that I want to be able to publish it before the end of the year. So again I think that should show you things are on track and investors.
Appetites are and whether for some time, we plan to deliver that data.
Perfect. That's helpful. And then my second question just on you.
U S glaucoma I mean, you beat our estimates handily what.
What surprised you most to the upside because I think clearly things are going well year to date, I guess, what I'm trying to get at or would you say the worst might be behind us in terms of.
In terms of the pressure points and maybe you've now entered a point where things are kind of hitting a steady state or maybe even improving hopefully that makes sense.
It does come I think.
We're halfway through the year I think we've been pleased with the <unk>.
<unk> and the stability of the core combo cataract stent franchise.
In the second quarter, we were pleased with what I'll characterize as early contribution from my access.
And overall the continued stability in the pricing environment I think to the core of your question.
I think we've had two pretty good data points. This year in Q1 and Q2 around.
What a life can look like after the proceed cut.
But I think it's a little bit early to sort of extrapolate that into.
Victory in terms of how this will continue to transpire and every day is a day that were out there, making sure that patients and surgeons are aware of the benefits of our products and making sure that we maximize the opportunity there.
Great. Thanks, guys.
We'll move next to Zach leaner at Jefferies.
Hey, Thanks for taking the question I just wanted to touch on that last question can you talk about some of the inflationary pressures in surgical throughput that <unk> seen through the quarter and then.
If youre seeing any challenges from staffing as well.
Okay.
Yeah, I mean, I think that.
We're not immune to what you've probably heard from multiple companies over the course of this earning season.
Thank you.
A combination of dynamics.
Inflation some are related to COVID-19 some related to the job market shifts that have happened.
It's clearly, causing disruption in the labor market and in staffing for Hospital Administration hospital tax to support that helped make these oh ours in asp's.
Run at the optimal efficiency and and we hear often from our customers over the course of this year, including recently around challenges, they're having and maintaining that staffing maintaining those those or lanes running at Max capacity. So I think it is a dynamic that persist across the health care landscape and certainly with.
Ophthalmology as well.
Okay.
Yeah. That's helpful. Thank you.
And we'll go next to Allen Gong at J P. Morgan.
Yes.
Hi, This is Ravi in actually on for Ali.
I just had a question about kind of your expectations for Opex going forward, yes, some pretty healthy step ups in SG&A and R&D in the quarter.
So how do you think or how do you think we should think about.
Spend kind of into the end of this year and obviously not.
Obviously, you're not providing formal guidance, but on 2023, as well, especially kind of what's needed for infinite and ultimately idose.
Yes, Brian Thanks for the question. This is Alex I'll try to address that.
So we did reported in our financials 90 $91 million and as you know included in that number is $10 million related to this licensing agreement that we did in the second quarter. So we're going to you know the things we'll talk about now, let's just take that 10 million out.
So that we're sitting at about $80 million spend in Q2.
If you think about where we've come from this year. The first half, we put up about $150 million and in previous quarters, we've talked about our profile being around at $300 million of north of $300 million Opex company and if you just think about that what will happen in the next couple of quarters, it's probably about the <unk>.
Same as we saw in Q2, maybe a little step up so that your opex our opex for the year is probably in the $310 million range, maybe give or take a few million here or there.
The reasons for that or what might be what you expect right. We have continued investments in our R&D programs clinical regulatory activities that are ongoing with our pipeline and what we're doing as well as on the commercial side.
Continuing to enhance that organization, we've got new product launch activities happening and things of that nature.
Great. Thank you.
And that does conclude our question and answer session for today at this time I will turn the conference back over to management for any closing remarks.
Yeah.
Thank you so much all of you for your time and attention today, and we hope everyone is staying safe.
We also thank you for your continued interest in glaucoma.
Goodbye.
And that does conclude today's conference again. Thank you for your participation you may now disconnect.
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