Q1 2023 Glaukos Corporation Earnings Call

Welcome to your glucose Corporation's first quarter 2023 financial results Conference call.

Copies of the Companys press release, and quarterly summary document both issued after the market close today are available at Www Dot Guaco Stockholm.

All lines have been placed on mute to prevent any background noise.

After the Speakers' remarks, there'll be a question and answer session.

If you'd like to ask a question. During this time simply press Star then the number one on your telephone keypad.

To withdraw your question. Please press star one again.

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'll now turn it turn the call over to Chris Lewis, Vice President of Investor Relations and corporate Affairs.

Thank you and good afternoon, joining me today are glaucous, chairman and CEO , Tom Burns, President and CFO , Joe Gilliam, and CFO , Alex Thurman similar to prior quarters. The company has posted a document on our Investor Relations website under the financials and filings quarterly results section titled Quarterly summary.

This document is designed to provide the investment community with a summarized and easily accessible referenced document that details the key effects associated with the quarter. The state of the company's business objectives and strategies and any forward statements or guidance, we may make.

This document is designed to be read by investors before their regularly scheduled quarterly conference call as such for this call. We will make brief prepared remarks and transition into a question and answer session.

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.

Or are you in the future are forward looking statements. These include statements about our plans objectives strategies and prospects regarding among other things our sales products pipeline technologies and clinical trials U S and international commercialization market development efforts efficacy of our current and future products.

Competitive market position, our regulatory strategies and reimbursement for our products financial condition and results of operations as well as the expected impact of general macroeconomic conditions, including foreign currency fluctuations 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, 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 Dot cloud costs Dot 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 in the Gulf Coast is ongoing results of operations, particularly when comparing underlying results from period to period.

Please refer to the tables in our earnings press release available on the Investor 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 glaucoma, Chairman and CEO Tom Burns.

Okay. Thanks, Chris.

Afternoon, and thank you all for joining us.

Today, <unk> reported first quarter net sales of approximately $74 million.

Up 9% versus the year ago quarter on a reported basis and up 11% on a constant currency basis.

Our first quarter results and return to top line growth reflects continued strong performance across our international glaucoma.

Corneal health franchises.

Alongside the re emerging growth in our U S. Glaucoma franchise, driven by the initial commercial launch of Istent incident.

I'd like to recognize the continued dedication and performance of our teams around the globe, who remain committed to their work in advancing our key initiatives.

Given our solid first quarter and latest forward outlook, we are raising our 2023 net sales guidance range to 295 million to 300 million versus $2 $90 million to $295 million previously.

From a commercial perspective strong execution of key strategies within our core franchises drove an encouraging start to the year with.

Our U S glaucoma franchise, where we delivered 4% year over year growth in the quarter. We are progressing our combo cataract efforts and continue to advance Istent infinite ahead of establishing formal Mac coverage and payment.

In parallel we are accelerating our founding mission at glaucous, which is too advanced glaucoma care by driving intervention of therapies earlier in the treatment paradigm for glaucoma disease and in turn pioneering a new standalone market over time.

These efforts will be on full display at the Aas Crs meeting this weekend in San Diego, where an extensive array of symposia highlighting the performance of our novel technologies will be presented.

This includes our newest subgroup analysis of the combined Idose phase III trials, which demonstrated statistically significant superiority of Idose is IOP lowering effect versus current standard of care topical prostaglandin therapy.

We believe this first of a kind real world effectiveness data further validates the game changing potential of Idose.

Moving on our international Glaucoma franchise delivered strong broad based growth this quarter of 20% on a reported basis and 28% on a constant currency basis, and our corneal health franchise saw 10% growth as key strategic initiatives continued to take hold in support of this.

<unk> business.

In addition to our commercial efforts. We also continue to prudently invest in and advance our robust pipeline of novel promising platform technologies that we believe have the ability to significantly expand our addressable markets and fundamentally transform our company over time.

During the first quarter, we achieved a significant company milestone with the successful NDA submission of Idose TR, our novel micro invasive <unk> implant designed to continuously deliver therapeutic levels of proprietary formulation of travoprost from within the eye for extended periods of time.

We're also pleased to announce today, we recently received communication from the FDA and our submission has been received and accepted for substantive review, we look forward to learning of our producer date, imminently, which we expect will be in line with our approval targets by year end.

Alongside this our teams continue to make encouraging progress with the preparation and planning of the Idose commercial launch targeted for early next year.

Turning to the corneal health pipeline, we built strong subject enrollment momentum and the second phase III confirmatory trial for <unk>, Our next generation corneal cross linking therapy for the treatment of keratoconus.

And we are now on track for targeted enrollment completion by mid year ahead of our prior expectations of year end.

So as you can see we have a lot to be excited about when it comes with significant potential value that we believe our pipeline programs may create.

At the same time, given the macro economic environment and associated uncertainties as well as anticipated investments to support the potential commercial launch of Iqos. We continue to prudently review, the prioritization and cadence of our investments as we strive to strike the right balance of risk based investments and our capital position now and in the.

Future as.

As such we will continue to keep you updated as we evaluate and potentially adjust development timelines associated with our earlier stage pipeline.

In conclusion, I am very pleased with the strong start to the year and excited about what is to come as we continue to advance our mission to truly transform vision with disruptive droplets and game changing technologies.

And so with that I'll open the call to questions operator.

Thank you as a reminder, we would like to ask a question. Please press Star then one on your telephone keypad.

The first question is from Tom Stefan with Stifel. Your line is open.

Great Hey, guys. Thanks for the questions.

Congrats on the strong quarter and also the San Diego <unk>.

I think I'll start there actually kind of big picture with Idose.

Wanted to ask about just the technology and candidly not totally familiar with patented CIP et cetera.

With what Youre willing to share what type of Optionality does the technology itself have.

Maybe this can be in the form of drug optionality or even possibly licensing the technology and I guess, where I am.

Going with this is maybe even beyond as Idose TR.

<unk> rock, how should we be thinking about the value of the broader idose platform beyond just the products themselves in the pipeline.

Okay.

Yes, Tom I'll be happy to take that question. So this is something I've addressed previously, but happy to to be able to talk about it again.

I think idose is an incredible platform and.

So you've seen what we've been able to do with the prostaglandin analog travel costs Travoprost.

Being able to obtain 70% control patients on the same or fewer beds at three years in glaucoma.

You're also aware that we're pursuing a rho kinase inhibitor, which can be encapsulated in the vessel.

<unk> platform, which we think could be an extraordinary combinatorial treatment for glaucoma in the future.

The technology itself is pretty robust and it allows us to be able to consider a number of active pharmaceutical agents that we can be able to treat anterior segment disease I think.

We need to focus and we will focus on small molecules, so thats, where the limitations of the platform rest, but there are a host of small molecules that you can consider as we look to develop forward. These small molecules have to be invariably potent.

They have to have high nanomole concentrations and they have to be relatively in soluble <unk>.

<unk> said that you know that we must be looking at a number of different agents that can be able to exploit the opportunity of the platform that we've created and that carries forward into the next decade.

Patents on the on the technology, So it's software profound and take us into the next decade, both from a method and apparatus standpoint.

And then I think you know as well we look for taking the current product of Idose and being able to just with us through the simple modifications in the platform itself being able to create an extended release version that we're calling idose T. Rex that will hold nearly twice the amount of travoprost medication.

As the first generation Hydro's urgent version and we believe that will give us another kind of a material event to be able to launch a second generation product.

In the 2000 Twenty's.

So this is where we're focused as a business as I've talked about in general we have a number of platforms. Idose is an exceedingly powerful platform that can serve this company, both now and in the future with multiple variations.

Super helpful. Thank you, Tom and then Richard.

My question is just on the guidance.

Great to see you guys raise it I guess just the components of it.

How should we be thinking about what's changing I think U S. Glaucoma is thought to be flat, but that was really strong in the quarter O U S glaucoma low double digits and corneal health high single digits previously.

Joe or Alex maybe what's changing and then as a follow up to U S. Glaucoma just on <unk>.

Any updated view.

On your potential I guess level of confidence that we fit a true point of stability with with ice and the U S.

Maybe we are past the worst of Reimbursable had willingness so two part of the air but thanks for the questions.

Sure Hey, Tom It's Joe I'll start with that and have Alex wants to jump in he can.

It was.

Could you dig in more Tonight, It was definitely a high quality first quarter.

Solid execution.

We are pleased to be able to raise the guidance by $5 million as you noted.

If you think about that in the context of the individual franchises. The way you asked the question I am not so sure. Despite the strength in the first quarter across the board that there was a significant material change to how we thought about the original guidance on our franchise by franchise perspective, although obviously, we're slightly incrementally positive.

Across the board and probably in U S glaucoma in particular.

We still want to be somewhat cautious as we make our way through 2023, and particularly until we get more certainty around the Mac timelines associated with Istent infinite and what that can mean in terms of accelerating the growth of the U S franchise and our business overall in 2023.

As you talked about one sub component of that obviously is the combo cataract mix business here in the U S and you characterized it obviously as I said.

I think we.

We're encouraged to see continued stability in the quarter in that franchise as well as actually a restoration of growth in our combo cataract business for the first quarter and as you know coming out of the last year, where the the CMS related headwinds, we're having an impact.

It was a very encouraging sign to see that that return too.

Our growth cadence as we started the year.

Very helpful. Thank you.

The next question is from Margaret Kaczor with William Blair. Your line is open.

Hey, guys. This is actually Mike on for Margaret Congrats on the nice quarter. Thanks for taking the questions. So I just wanted to maybe start out on the quarter follow up a little bit on your comments.

U S. Glaucoma was there any new products that you would call out having tracked better than you expected this year like maybe I prime.

Or even I access or was it mostly the <unk>.

Core ice day, returning to growth like you guys mentioned.

Yes, thanks for the question Mike.

It was it was broad based in the context of the stabilization and the growth we were able to demonstrate I would probably characterize it.

It's a little bit of a recap of what I just said.

The starting point was stabilization and some modest growth coming out of the combo cataract franchise, which now we ultimately have multiple potential tools working within that and then on top of that we started to see that.

The impact of Istent infinite in particular and I think we were we were if I was going to call. One thing out I would call out Istent infinite in particular is as really being a nice driver of the performance in the first quarter of the outperformance versus our expectations for sure.

Got it that's helpful. And then maybe one longer term just on the Standalone opportunity.

Hi, Stan and connect picking up and then Idose, becoming part of the picture next year, you guys had mentioned, making an effort to maybe raise awareness for standalone intervention in the market can you maybe speak to any market building initiatives. He started to look at are made pursuant of the future.

Yes, I'd be happy to Mike.

And then I'll, let Tom jump on as well because quite frankly this has been something that's been a part of the founding mission here, which Tom has been apart from the beginning so I think it's good for them to comment but.

As we sit here today, we're putting a lot of effort and investment into really changing that that mentality and that treatment paradigm.

And you've heard us talk for years about the fact that topical medications work.

The challenge with topical medications as the compliance rates in some of the side effects and various things that come alongside us.

And for US now that we have available a suite of tools that are truly minimally invasive enabled intervene and I think an attractive way from a risk benefit standpoint now.

<unk> is really the time for us to be putting that behind it.

It's an organic initiative more than a traditional marketing program right. This is about the leaders of the industry out there the key opinion leaders.

All of the various folks who have been saying this for some time and us trying to really help draw.

Drive that the energy and enthusiasm behind that to the next level, particularly as you think about it in the context of <unk>.

For us Istent infinite and then Idose going forward as two important tools to help us. So it helps support that from a product standpoint, Tom I think what I would say Mike is that.

Mmm led by the catalyst of dose and I spell Internet.

I think the question always comes up where will they be seeded and where will they take place when we do launch Idose and certainly it's happening with iced, an infant and as we speak.

We know that surgeons will look to suit of taking patients first while they get their sea legs on a standalone basis.

And then there's a whole array of patients that are non compliance that surgeons and clinicians conserve you've seen some of the recent data showing that there is the rate of noncompliance can be as high as 90%, which really encapsulates most of open angle glaucoma patients.

There is tremendous promise to serve patients that are intolerant to medications those patients who have high degrees of Hyperaemia allergy carryover lowfat atrophy et cetera.

And I think there'll also be a tremendous reason to reduce drug burden over half of patients who are diagnosed and glaucoma around two or more medications, which further exacerbates noncompliance and we can reduce drug burden by placing them on a foundational therapy like idose that can make a considerable difference.

Let's not forget as well if there's a huge patient convenience and quality of life factor topical drops are difficult and they are a nuisance and and a burden on quality of life for patients and so we do believe that another these surgeons will look to be standalone opportunities to be able to liberate the patients from topical drops.

And finally make that mistake that we think that surgeons and clinicians will look at currently where they're focused now any time you have a combined procedure like a cataract procedure and you have the ability to treat comb over to glaucoma, we see and believe that there'll be a strong appetite for the intervention technologies, such as infinite and I don't.

Mike.

Hey, guys. Thanks for taking the questions and again tip of the hat to Chris Lewis on the most efficient earnings call that we have here. So [laughter] I just wanted to.

Just wanted to highlight a couple of things I just ask a couple of things. Tom. So you guys highlighted the study today on the use of P. G. A his first XI dose and you know you submitted with the data package I recall, the repeat usage study and so.

Love to just get your thoughts and how.

Oh, you're viewing the data in the context of some of the other studies and and and you know each have their merits in their own right, but ultimately I think what investors care about is and what they want to know is what do you think the label off me looks like given the studies you've run and what are those studies due to kind of set the stage for utilization of items when it does come.

Okay, well, let me hit that head on the label that we're seeking is a wide open.

Label and.

And that label is based on a 505 b two designation that that basically is based on the predicate of topical possibly item therapy like a travel trust so.

So the labels that we're seeking is one that will basically say for the reduction of interact with a pressure in patients with ocular hypertension and opening angle glaucoma.

So that data that labour will allow us to to approach the full array of glaucoma patients and pre glaucoma patients who have ocular hypertension. So there's no restrictions.

The label has now been.

Sorry, I'm, just trying to find out what the duration of effect is the duration of effect will be served by our phase two these studies, which show again at three years that were controlling the vast majority of patients on the same or fewer topical medications and that's how we'll go to payers and so that's kind of the seminal interest there when I was.

Look at the data that you've just talked about I get extremely.

Excited about what the possibilities can be this is a subgroup analysis of patients that were on pretreatment topical prostaglandin. They were washed out of the medications. The pressures went up so roughly 24 millimeters and after the implantation of I'd dose of pressure is actually.

Driven lower than they were pre treatment.

And in a matter of fact here on the on the order of greater than a millimeter, which by any indication that any surgeon will tell you.

Will lead to a 10% to 32% decrease in the propensity for black Communist progression. So this is a highly statistically significant funding and I think one that will help us not only talked about the long term view of eidos, but actually the more shorter term.

Real world efficacy versus the topic across Glenn in therapy.

Okay. That's that's very helpful.

Fulltime and.

Certainly looking forward to it.

Patient itself Yep, congrats on getting accepted.

Just want to be clear, it's no <unk> yeah, you're not are you waiting on a day 74 letter what I just wanted to be clear when do you expect <unk> and make sure there's nothing to read into their given that you don't have that in hand, yet.

No. It's a good it's a good question we have high confidence.

That will be receiving the Dave 74 letter literally literally in the matter of a few days.

And so our expectations to be issued a produce the date at that time, which will then put us in place to achieve our target of FTE approval of Idose by the end of the year.

Okay, good stuff guys.

Thank you.

Welcome.

The next question is from George Sellers with Stevens Your line is open.

Hey, Thanks for taking the question I I just have one on the international side of the house could you just give us some color on how some of the international upheld the market's trended throughout the quarter and then also have you seen any increased pressure from a competitive standpoint internationally. Thank you.

Hi, George it's Joe.

I'll cover that from an international headlines standpoint. It was it was a standup quarter right. We had record sales are a little north of 21 million and and.

And just strong performance across the board across the various regions I can't point to any particular.

If vince that generated the outsize performance in the quarter. It was it was broad based across the Americas across Europe Asia.

And and really on a on a global basis.

I I think that we.

We continued to do very well in virtually all of the markets versus competitive forces in particular, we see that a bit more pronounced in Europe as you might expect and I think our team continues to do a great job of upholding.

The line and continue to grow that business.

Quite impressively in the face of of of a lot of effort from from competition.

I think it speaks a lot too.

Out of.

Data that we've generated over the course of the last decade, plus around the optimization of the risk benefit calculus associated with the with the ice that franchise. So.

We couldn't be more pleased with the continued performance outside the U S.

Okay, Great I'll just leave it at one congrats on a great quarter.

Hey, George.

The next question is from Matthew O'brien with Piper Sandler Your line is open.

Hey, this is Phil on <unk>, thanks for taking our questions.

Clarification on the I N D. A process here an apology.

Rudimentary, but by my math he received approval at the end of last week and because you're still expected.

The <unk> by year, and you expect to receive accelerated as opposed to standard review here and you know what exactly does that six or 10 months Clarke began.

<unk> is your is your problem.

I believe it was on February 27th and so we'd be looking at a produce a date that would be ranging.

From there actually forgive me February 10th.

And so we were looking from that is the starting course from the date of when we file to when we expect to receive that produce the date and.

And so to your question of the day 74 review should identify that produce a date and then give us a mid cycle reviewed that will be entertaining with the FDA any questions to move the the.

And the submission along and again, we remain confident that will be in a position to be able to to achieve a potential review approval by the end of the year.

Okay. That's that's helpful. Thank you in and then just one on guidance I mean, you'd be by about 6 million in the quarter raised by about five.

Is there any reason why you're current expectations are about the same now than at the start of the year and specifically at that pertained to staffing we're hearing about this backlog in.

Pertaining to step in any line of sight until when that might be getting better.

Sure Phil I think well first just the macro point around passing through the the $6 million of outperformance.

Think five versus six is kind of a rounding error in the grand scheme of things that.

You'll recall, we didn't really give Q1 guidance we gave.

Annual guidance, so I think that that's.

That's generally a narrative that probably needs to have an Arab are established around it before you draw any conclusions on it.

More broadly speaking I I'd say, obviously, it's still early it's only been two months since we established the initial 2023 guidance like all companies reporting in the first quarter and and we're pretty clear that we wanted to walk before we run as it relates to setting expectations for this year.

And I believe our guidance right today is a strong step in the right direction. If you think about it.

2023 for US is all about establishing the strongest foundation possible ahead of what we hope is a is a transformational period for us with infinite Idose and then ultimately at the accident. So Q1 was a good start in that direction, but but it's still early.

Thanks for taking my questions.

The next question is from Alan Gung with J P. Morgan Your line is open.

[noise] Hi team congrats on the great quarter I'll also leave it at one since I think a lot of the most prudent for any questions I've already been asked but just you know thinking about the tornado health fitness and specifically at the off at beyond my understanding was that the orphan drug designation for.

At the off would be expiring this year. So I'm just curious if you had any visibility into any potential competitors, maybe you're looking to start their own trials or if that's something that you know we still have to wait a little bit longer before you see anything on that front. Thank you.

And what that does is allow a competitor and to begin to file for approval, but to answer. Your question directly were aware of no competitor that has entered into a fulsome phase three clinical trial that would be.

Competitive to us and so therefore, we wouldn't expect to see any alternative version of any.

Cornwell crosslinking procedure for several years.

The next question is from David Saxon with Nina Your line is open.

Hi, guys. This is Joseph on for David Thanks for taking our questions.

May be continuing with <unk>.

Cornell House.

Do you think maybe we're at a point now where reimbursement is no longer an issue for dogs.

Or would you say, maybe there's more wood to chop there for the <unk>.

Get access team and then.

If possible could you maybe give us your thoughts around.

Penetration there.

What kind of traction you've seen.

Outside of.

The group of doctors the high volume group of doctors.

Yeah, I'm happy to talk about that in the context of the overall Cornel health franchise I think in general reimbursement will always be in focus for surgeons and their practices, it's highly relevant.

They're always going to be watching and monitoring what's going on there I will say that one of the more significant investments that we made over the course of the certainly the second half of 2022 was was in the the payer side of our commercial our market access organization and I think that's that's certainly.

Made a difference for us in terms of our speed to address.

Issues as they emerge with commercial Payors and our ability to stay out in front of those as best you can in a world that inevitably always had some volatility.

Really.

We're pleased with with the.

The investments we've made there and how that has I'll say, thus far quieted some of the volatility that we have seen historically and then how that translates of course into.

I'll call it reimbursement confidence for some of the surgeons.

That that deliver the butcher exit therapy as you asked.

I think more broadly you asked about penetration and I I would say that.

As we continue to drive investment in this business.

A big portion of that from a macro standpoint is towards raising awareness and the diagnosis of the disease. I think there are a lot of practices out there who perform for.

<unk> and cross linking today, we've done a great job I think of of getting the technology and the solutions deployed out into the market one of our bigger challenges over time is to continue to drive that awareness.

Of the disease to make sure that these patients aren't getting lost two alternative therapies that put at risk the corny quite frankly, so we've we've been doing quite a bit around initial.

Initial called creative DTC campaigns, and the various things you can imagine as well as helping the ecosystem to drive initial diagnosis and referrals to those centers, who who offer the food trucks with therapy.

Okay, Yeah great.

A lot of sense, and and maybe building off that a little bit more.

Just given all the investments you guys have been talking about I was wondering if you could maybe give us some kaden surround opex spend for the year I guess like quarterly cadence.

Hey.

Joseph is Alex all happy to answer that one so.

I think the way to think about it there's a couple of things first of all mentioned that we printed $88 million in the quarter for Opex, but there were some.

Alcon non-recurring one time items within that number of about $5 million, none of it related to the items that the.

Related to some stock compensation. So if you think about backing out that you get to about $83 million more normalized basis.

So starting with that base the way to think about the cadence for the rest of the year is if you take that and assume some modest increases over the course of the year. Then you are going to cut.

Right at the end of the day near.

Near what we talked about and the last car, which is around 10% growth rate over our last year normalized opex levels.

Okay, Great. That's super helpful. I. Appreciate it you guys. Thanks for taking our questions and congrats on a great quarter.

Thank you thanks.

The next question is from Anthony Fatone with Mizuho Group. Your line is open.

Thanks, and congrats on a strong one once you're resolved here.

Just the base business one on on on Idose, Yeah, just on the on the base. Obviously this quarter, where we're hearing a lot about procedure rebounds, and we're seeing that not the Molly G as well, although a little bit nuanced with with J&J earlier in the quarter and so when we look at the core I stem business just trying to get.

An idea of where procedures are at this point.

And if there's any backlog recapture that you're seeing.

Quick follow up on Idose would be just just a clarification on on the <unk> date.

There a panel advisory panel meeting that you're expecting just updated thoughts on that process. Thanks again and congrats.

Yeah, I'll I'll start and then I'll hand over time for the second part of your question I think the overall.

Markets both in the U S and the majority of the market's internationally are pretty healthy at this point in the context of of the combo cataract the volumes and I think to your point, you've heard that somewhat consistently from from others and I think you'll continue to hear that.

Still are the dynamics around staffing and I'm sure that leads to some backlogs dependent upon the practice, you're talking to and that will continue to work itself out it's hard to point to that as an individual line item contributor to any one period of time any month or quarter I think.

The reality is that these guys had been operating on the margin with a little less than optimal staffing for some some period of time now I hope that continues to lead to a bit of tailwind, but at this point all I can say is we definitely do continue to see expansion of the market and both the core combo cataract market.

But then if you think about it probably even more importantly, the beginning of the opening of that broader standalone opportunity with with iced an infinite as we lead our way towards towards Idaho, So I think that as we talked about.

Over the years that broader opportunity from a growth perspective should dwarf the combo cataract market that we're talking about today.

Okay, and then I need to make one correction thee.

The NDA, we submitted was on February 22nd I think I mentioned I thought it was on the 10th and so February 22nd and we filed for substantive review on April 23rd and so our expectation for the produce of data will be on the fifth with the day's 74 letter.

And so we give them that rationale we expect to receive that produced the date again by the end of the year.

We do not expect to have to engage with an advisory panel.

Thank you so much.

We have no further questions at this time will turn it over to Tom Burns for any closer remarks.

Okay I want to thank you all for your time and attention today and thank you again for your continued interest and support and Glafkos Goodbye.

[music].