Earnings call transcript Q2 2023

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Operator

Welcome to Glaukos Corporation's Second Quarter 2023 Financial Results Conference Call. Copies of the company's press release and quarterly summary document both issued after the market closed today are 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, Vice President of Investor Relations and Corporate Affairs.

Christopher Lewis

afternoon. good and you, Thank

Joining me President Thurman. CEO, Burns; Chairman are COO, Joe Glaukos and Alex and Gilliam; Tom today and CFO,

the company's that Similar we be quarter, under of summarized reference company its regularly document to is call. Quarterly with Summary. the the Quarter the a any a is read and titled provide prior the on associated key designed the document may be document community quarterly to Results has section accessible Investor to investors by Financials document and guidance objectives the with business forward details effects the posted This designed or website strategies easily to conference scheduled before This and and state -- Filings Relations statements quarters, make. investment

will As a into session. and for call, such, this brief prepared remarks transition make question-and-answer we

one you To request to one ensure to questions, everyone's and ample and time that yourself limit address follow-up. we opportunity question

still have If get the additional into may you queue. questions, you back

statements are events or all on address that Please note expect, call this statements. the other activities, made facts of developments in future occur or statements anticipate historical may believe, we will forward-looking or that than

and results on general as competitive market operations macroeconomic condition fluctuations other sales, current and foreign objectives, position, regulatory for future of including and plans, our currency and financial include about efforts, our of and development strategies and statements efficacy trials, These as our international operations. products, impact conditions products, products, and U.S. prospects things, regarding, clinical strategies the reimbursement technologies among our well pipeline business expected of our commercialization, market

our to to and risks, factors affecting about recent uncertainties future results are difficult today's business differ implied SEC risk our these beyond of predict and control. statements current information more statements. press relating based by and subject those Review and many forward-looking to actual which for These materially they our operations all of are us environment, or about cause are from release which Therefore, factors. to and events on our are may expressed filings expectations

find website at You'll of documents www.glaukos.com. section Investors the these our in

to into Investor Finally, of the an including the We Glaukos' call, financial a today's basis. in also when believe ongoing press financial on results refer measures during and particularly earnings results note we more discuss certain underlying adjusted period. our measures, of can to period from greater comparing section results our Please available these non-GAAP analysis operations, website. release please that tables transparency in Relations complete facilitate will

most For these a financial to of measures the reconciliation measure. directly comparable GAAP

Burns. call that, With Glaukos and I turn will CEO, Chairman Tom to the over

Thomas Burns

versus our Today, Chris. XX% teams work to Okay. and launch of and globe franchises Corneal $XX.X continued thank remain advancing strong by like the our sales around glaucoma alongside commercial consolidated our driven million, afternoon the performance and the you reported across up infinite. the initial Thanks to ago record U.S. dedication results joining and committed congratulate record quarter. These quarter I'd growth in to of key their for year Glaukos international Good second quarter all, all of glaucoma again, and to net us. reflected second the our sales reemerging franchise initiatives. iStent Health performance who

ahead sequentially, formal payment. advance Within glaucoma our record drove of grew franchises to solid million the XXXX $XXX our latest strong iStent commercial and to $XXX our Versus we year-over-year MAC franchise million X% establishing delivered core which where quarter. our of execution sales within From a $XXX to are infinite our net of our Given $XX.X of strategies quarter we raising million. XX% second perspective, sales we key outlook, each to U.S. million, $XXX forward and and previously. million coverage range guidance continue

our to front, that assess iStent MACs steps temporary approval coverage that requests. have taken infinite, either iStent based of infinite issued with consistent X LCA if coverage preliminary through or upon proposed MACs total, provide X reconsideration FDA X for LCDs and LCD have finalized proposed the coverage would reconsiderations In On all updates.

procedures, lifted part support access MAC physicians tools encouraged and to are continue ultimately XXXX. XXXXT APC to they code rule finalized as we expanding XXXX in future. as the processes CPT Further, glaucoma to CMS monitor from the closely and infinite broad has the to iStent to the used also cover will see interventional proposed been XXXX were and and various APC We of for policies stand-alone advance

are proposal more it as cost stated in similar of procedures. stand-alone and with the We believe, this and appropriately reflects the that have we pleased initial past, infinite

move proposed will cataract XXXX. claims go January to history APC effect as plus which also CMS into changes procedures finalized, XXXXX XXXXX trabecular restructured combined the APC for X, believe bypass to CMS XXXX, in also Separately, the If newly a assignment appropriately we rule. these the proposed and reflects stated

and our earlier, strong mentioned year-over-year a of $XX.X constant glaucoma on a international record reported As a based on basis. on currency delivered XX% XX% basis franchise million broad of growth sales

As we we major are of in world. and as continue standard region to the in care scale MIGS market towards a every increasingly our driving each international infrastructure,

support new driving disease execution, care the founding treatment a in of near-term to is over by also focus pioneering our for at in are intervention we stand-alone we and, which of market earlier therapies accelerating missions to time. turn, While one on Glaukos, paradigm glaucoma advance our efforts glaucoma

the in numerous thought lead June. meeting Meeting at Society continue this with Rome in events of more and and evolution Biannual standard and ASCRS in globally broader to closely to World We annual Glaucoma the including recently in the drive surgeons organically May at work leaders care, through

business. of important million this year-over-year to key sales our past Health franchise XX% Corneal initiatives growth a growth, XX% on including delivered implemented sales the take as record support year-over-year strategic $XX.X finally, of of And on year record in throughout $XX.X million Photrexa hold of continue

front. the development to gears Shifting

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

iDose of step therapy acceptance in step quarter, previously TR, During we one game-changing for important patients. NDA the submitted FDA closer this bringing to another the announced marking second

to towards continue XXXX. we encouraged review as process agency's as established with PDUFA the XX, progress FDA ongoing work be date their December closely the we and We goal of

of XXXX. this, early make Alongside remainder planning robust commercial literature nice and launch including to the a continue next into year the to targeted with of teams our be iDose the preparation published set progress over expected and for of peer-reviewed year, this

Health Turning pipeline. Corneal to the

the trial for the treatment testament favorable rare enrollment second closer disease therapy, one corneal Keratoconus. from next-generation therapy this suffering less patients for risk-benefit which quarter, keratoconus profile second our threatening the a the step commencement This is months corneal in therapy this in cross-linking our in well we next-generation as X During of completed is as team's from Epioxa, earlier hard sight enrollment year, a of than to trial completion, III expeditious to Phase important which this bringing confirmatory work occurred disease.

XXXX. We outcomes the look patients end forward of submission Epioxa to NDA following as for target these by we

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

capital of to of last and the right discussed position same as At balance we future. prioritize continue we the time, in investments cadence quarter, as now our risk-based the investments to we our the and strike strive

to early non-GAAP, continue of that, programs of moderated SG&A pipeline evidence year-over-year quarter growth, we've expenses prioritize earlier-stage reflecting resources of R&D anticipated the to As next commercial our some initial launch we development as and ahead second operating the in adjustments our iDose X% in the year. made our

So truly sight pioneering quarter momentum suffering for can dropless very standard transform diseases. care continue vision and our by patients eye I'm and novel, improve in platforms pleased business the that to with we conclusion, advance outcomes record chronic as in mission advance successfully threatening meaningfully from to the building of our

that, the I'll for call questions. open Operator? with So

Operator

[Operator Instructions].

Our from Stifel. first Tom will with line question the come of Stephan

Thomas Stephan

Great.

what XXXX one, your guys' picture, you launch guess, the , hear iDose. like? successful different big in First start I'll does numbers. with minds, I look in

try year decent number. million point benchmark as has as cited rating But million to if refine iDose a hitting been million Is $XX now the starting even iDose for closer I would $XX very be just think X for any the our about that year or in to market. run it's guardrails a we're models $XX helpful. getting much range. But that we more how XXXX to to X think

Joseph Gilliam

add Tom, it's color Joe. at end I'll may and commentary too. want Tom the start, to some

ways. iDose, about to how we're obviously, going couple success? of comment specifics of define think and to we As given number, guardrails of on going a I think different any define not the I'm in will success we the

specific need the to the broad the is our for minimally continuing of out the to around that First, training you've of and right story focus kind intervening of we deliver outcomes mindset on the technologies. really of invasive that the reason gate. right enough been safe with the drive the glaucoma and more kind surgeons interventional But launch, and for making long to know theme these and sure

the to this we're iDose particular for drive going Obviously, everything else as about from and future, make optimal you our way know as over we doing achieving to we're the means in put we're number it ultimately year. doing and sort reimbursement achieve to prioritize right the building quarter So well outcomes that place in that both of perspective blocks what surgeon's success going right the the or target and the long-term enthusiastic sure to way, right go any for success.

Thomas Stephan

trends you speak product XXXX into on some would fee. of just about momentum pivot facility then the Maybe think, That's terms with you more to color any in to helpful. do just then in the really see mean can you U.S. to the here specifically, think that fee doubling maybe X-parter, a it. to encouraging I ASC product? and good that can could facility And take over product? Can that with what you provide XQ, of of very proposal, Any there's opportunity And be a infinite, Got for price in the but to a Internet maybe talk helpful. even date

Joseph Gilliam

Tom.

at as particularly X label the we're context and which for is it you as the coverage you the know, product largely articles that's side, our in of or when having coverage within LCDs of it as local side I through and MACs request utilization encouraging really other and we terms broader adoption proposed first, to the draft with where trends addressed formal via infinite, way with X way both formal the continue on the coverage just X our reimbursement MAC aligned here, seen well the pleased really put -- side, of payer the and with having momentum the as So early wind see LCAs. process the we iStent think Medicare the the we've commercial coverage be in to of

process. We're making still way it's through our But that early.

utilization iStent achieving proper And from for so around though through to its for we're that of need various momentum the this and like our potential infinite the Even in speaks working the lot formalities commercial payers marketplace. a a the seeing MACs still way product we're coverage the matter. and

facility remarks in to prepared process. the think obviously to matter. said I infinite the we see would for time on what in to heard you it XXXX, with we've fee see. given fee the And and as pretty know, you But it combo facility proposed that that takes the relates cataract expect pleased consistent work that it's rule relates to sometimes data we as some it we're the the Tom through historically, for reference

And means XXXX. in proposed that the be rule, what pleased obviously with so here for to we're

gets is terms and in multifactorial pricing, -- your portfolio, it really know, and attributes, it's you overall of product reimbursement. [indiscernible] pricing competition second of As yes, product question,

site-saving can And to so finalized, changes, for makes And facilities that. the I reimbursement procedure to benefiting of will they're I at that I the that the these receive thankfully think end appropriate them. up feasible procedures say what think if patients economically enable proposed is do end

Operator

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

Ryan Zimmerman

guidance. And want nice ask I guess I to on results here. first

seasonal in based where historically quarter. this with it going half of Joe, the kind a where down the back on strong I'm is at an absolute the look you know on to step guidance a of is you what kind as year, If results, basis going and dollar relative fourth of implies question,

process? So -- thought of your color kind any on here

a X behavior? follow-up. the on MACs, is question physician kind just LCD second have seen the I in quarter what other what -- kind and that from impact And in quarter? part then And second you the the And in of this effect the of proposed has have of had numbers

Joseph Gilliam

-- obviously it Ryan. Sure, expected in context. that

strongest an think expectations well, the second from think board. it Obviously, XXXX, and all period Epioxa. first. our our possible execution really it about transformational foundation us, will half company and of -- for think let across for a you start with I building a be forward quarter the going ahead remains about first pretty what the infinite, When exceeded was we me standpoint, it high-quality iDose

have but front us we continue that So had in in of start the a lay good we work of as first a to foundation. half, lot we

I bit a and think to what's us use we reflect to year, in to walk color I'll ran, and here. to to the think starting we're clear little the outset that. give probably at of same tried of jog included we were reflects guidance. have the today What I of analogy. pretty wanted try And we giving the related update as here before it we

tried pointed tried this fact in to that what feel trends enabled bit, can an their the half look also bit broadly healthy started reflect, to the we to maybe a you to We've obviously, the we of than staffing half that that you as -- elevated to as health and constraints that a more We've factor some across that ease and trends in first from first do, all pretty been XXXX, through accounts even see the and the landscape care that have procedure in work mean. backlog. and issue encouraging even

of assumes And LCDs that any a So included bit particularly it finalized we the relates is LCD a to finalized. our second when a from assumed we've the in material in part steady more in normalization a reported not we this process, the for infinite. talk half. second. XXXX, in we but the assumes today the that really reality no remain second there's guidance of also It more ties of which really -- about exactly that benefit be But I'll little to of into as terms your what iStent of can it question, we've will in get certainty that state those context in

can that to know iStent better especially potential quantify once obviously And we that, the has, infinite. impact we

seasonality, summer coming that's we in have We would And QX we more recent particular. years to out in factor of in the in which globally been in COVID. do pronounced

more dynamics, the as second that competitive ongoing the Alcon into of the question. from your as And ties then And well your part -- of including really some invasive procedures.

of wouldn't I marketplace. and LCDs proposed. haven't from at these the think of products. the all we've as proposed the impact now context changed rules the any I They say seen for happening here much of in in an what's those coverage They're

the of operate I exists to And and that expect on so would they reimbursement the as do, have they largely until continue the basis surgeons coverage been that today.

Ryan Zimmerman

want to one Very on Okay. thorough I that. squeeze more. in

what and launch spending, talked prepare that. products an a we're for the around in Tom, arguably the and of is I was kind moderating to thought given about about of comment history biggest company's interesting you Just, that one

the what kind P&L, And on of mean iDose earlier a to about standpoint? is question and mean is successful launch. how what sell market go from think of the maybe so other in you But spending talked I moderating of the a terms commercial side I

Thomas Burns

it, Ryan. Great Yes. answer to Happy question.

programs organization these development talking really So organic as that we're in of array forward. about when extensive talk I moderating, blessed an about to have the carrying been we've we're

prioritize investment that to optimal establish use our me benefit for return And and best risk and capital shareholders. compels so the way in me on obligates to and to

doing. And so we're that's what

towards we conclusions. the tell iDose. our of wouldn't that capital that launch you we'll successful I significantly timing. a target tremendous be of of draw -- That would have question wrong I So is employ the

that of some expect later I on to and XXXX. into occur this year

launch so understand order company. this could for we the And the that of mean magnitude

And it a so necessary we'll put the make capital you make necessary that I to -- launch can success. assure capital this behind the

Operator

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

Charles Ellson

on Charles Larry. is This for

nice on the congrats quarter. First

thoughts you XXXX. I of a half could you quick cadence if you give sales seasonality. a the know on back little I question, of follow-up mentioned through guidance. on a summer First -- wonder mentioned quarterly little

don't know of thoughts that's bit And then that is I a QX QX implying a a have on on that. little a if iDose. step-up, some but So in quick maybe lower I follow-up

Joseph Gilliam

-- hit think you I Charles, Yes, that's you the with it way really the question. asked

-- drive we've out to seasonality in way the basis. summer quarter. If I to years you dynamic in on the the The implied half. procedures global back looks a look return plays of think guidance -- half second is And in last itself here that as recent tends doing that like seen a month lot the the the a people somewhat quarter fulsome third first

we'll summer that bit would expect that downtick that So see of how this seasonality, But at recovers yes, then I QX point, sees out. a a QX. in plays that from and

Charles Ellson

and And iDose. then Great. a then follow-up -- on

So you you no upon how a reimbursement How you iDose do said catalyst -- you you setting. work plan adoption? then that on take approval? office also, for think still after do big And the do to launch? the long procedures And think repeat restrictions expect that's might for towards could in

Thomas Burns

be I'll those. happy to Yes, Charles, take

So at restricted expect all to exchange. your not on be or first in was whether we question

be over study, did an this answered exchange we to IIb we've imposition and And no real patients we the were following treatment saw study express if that substantive X in XX that confidence recall, that had patients between control. and reconsenting before so And continue for and that, by we won't we our differences years you us. Phase

study. that we restriction have we feel that confident into so not And a going will

surface again, that I both this to able way. office do in to regards ASC. in twofold One, want of be and how to iDose we or important surgeons in the the it's we launch, take provide to to site a the certainly offerings with Now go will

MACs we be Recall professional appropriate That see will of fee. launch, an They'll first year. get half the over that to assignment establish as will then be approaching we'll the -- an an typically, that APC. be we to to

X recall, J-code. side, typically we'll you'll in launch. payment and be for drug able have a the J-code HCPCS my On get to which a miscellaneous former a takes file experience others, code at we'll to And quarters

That J offices. to in code apply ASCs both and will to

iDose to part of MACs of that's an And so believe need in-office approaching And we non-facility payment. establish to will when is we'll done we about by do which talk use time. use, the What important become individually. over the

need society specialty be society will do We we'll for will is to the in expense -- get we'll professional which payment develop will what a what be able non-facility up work be and office. these MACs will support And the consider, fee basis to which KOLs. practice for

And no payment is as typically, the in non-facility the is professional there that is in facility because no fee you higher non-facility there payment. recall, -- because

expect professional the So the fee, side. will the on we professional ASC fee exceed

something is fairly. happens go MACs. It we as This that forward happens with case-by-case the

game-changing be as component important will what office something IPO, will we we've ability But occur be time. said of will term. an a probably that this So longer site I've as over physicians in to the now, for service it use since our had believe give a will technology. be the To

Operator

the George Sellers Your line comes next question Stephens. with of from

George Sellers

Congrats quarter. iDose. a Sticking on great with

the anything and expected we But of curious, infinite take of to the as I'm reimbursement through the it from of is of that You've with despite can obviously there kind with working processes just infinite MACs. iDose, commercialization relates had some iDose? success adoption apply iStent commercialization to some iStent

look sort But on together? you infinite reimbursement coming ways. a and for waiting know little approval progress. I fully than bit complicated we're expect And more could it's to And like prior do that in of what demand how to iDose a of lot still

Joseph Gilliam

experience different hard and the Yes. targeting. I a indications it's think different they're mean have to populations direct that different with product the and I one draw versus line given between patient they next, labels

way right that infinite think products process. way from we way that way we the take and can't you in reimbursement the these it through the way, thing our to our the the train that commitment we surgeons and the being is I our make methodical launch to doing

of white lot And go example process of iDose, that of products Over a I earned into will be of couple some a new forward. in decades, we've as in spaces. another we launching through experience respects this going think

play XXXX, I of example, for we this think our what guidance get versus there's getting we when in at that there for we'll we that ahead expect address -- enough for to year now point. variables that

George Sellers

bit. sense. That switching makes little a Maybe Okay. gears

you current assumed that You this also that? some agreement with also Radius And incremental if recently the then from year costs with you're XR. expecting deal. announced Any details maybe in curious additional give could I'm that on an just what's associated And guidance?

Joseph Gilliam

Yes.

start So order. reverse I'll in

call driver factored of it's as and stage. market. anything I time this think standpoint, talked why call I role there. and wouldn't is a the growing it's guidance we've some -- out yes, But guidance behind from it at an pioneering expense I doing particular about Radius immaterial. the these pretty from in and perspective, we're wouldn't material markets about that in what really is a our

make themselves and that part an retail service or they're a in a first it it setting. be way And them is optometrist, that helps the obviously, MD democratize Whether presenting Walmart these of a from be ultimately, we're site screening in optometrist testing trying sure identifies patients helping to and standpoint. that of to like optical wherever whether

diseases That of identifying hopefully they need access the getting more for technology that and threatening they're and kind sight care later. to them deserve test or than and getting early and these efficiently easily sooner them rather can them that

of terms in to patients. these deploy Today, really actually when you diagnostic stands, some they as they centers, know, and even they're as of alongside where limited the diagnostic of most, many or these capabilities technology the in it test optometry in particular, have,

can think and equation. of that muscle the And that that the so incremental help Radius drive democratize technology and best-in-class truly some that putting really we diagnostic we screening hope is by our side behind is and

Operator

of Wuensch comes line with next Citi. Joanne question Your the from

Joanne Wuensch

your what One different question we've at us is ASP number is, tossed curious numbers sharing are second a the for have stocking? you for OUS year? two what comfortable you things. is new of is continue with of you And this then region stage didn't And remainder a is the curious or demand I'm would I not the strong. the heard mix up, opened be pent-up iDose if about I'm whether really And there because around. or any surprised

Thomas Burns

Thanks, Joanne. take the part I'll first the question. of

regards with are at contemplative. be. So still a contemplating in what we Markov what iDose J factoring transition the I've pricing, and for highly price I'm in of code as illness to -- X probability will And that burden months looking are we of charge $X,XXX said all being analysis. analysis, derisk along, therapy. over We're

I'm are that And side, until retinal think will hear would be the price. basis you to for pharmaceuticals, the side surgical will and and anterior which segment we me the guide I what I price expect on looking I both think approved. FDA also not at fair on in a compelling

will our make the And time. take so then we'll time short FDA and and contemplating iDose. be we we'll that. you get approval, some right sure for We'll disclose pricing after hear We'll it

Joseph Gilliam

international really, reflects teams XX% I think, [indiscernible], [indiscernible] constant really currency another And of based, execution on quarter, record regions think, the I It growth was year-over-year and globally. across standout our was it by that our strong broad all sequentially. side,

in of some markets, like U.S. doing for each the time. care think you we've these standard a about in just of If really in it, we're been pioneering change

treatment we've stage we're the markets the all these in and of in today today all each different -- that of -- build the know dynamics both bit are all markets are in that. And a algorithms, a done of in marketplace you broader various here things support, surgical the little community, that the And the to terms different the place. these from exist of reimbursement in MIGS little

we're through markets business. in way the much that we're making building we're growth of and really of virtually so in, still in the And our still phase very all

unique any drivers any regions or add didn't new here. We

the of a felt there a XXXX the touch little couple year-over-year at I lag standpoint, those growth numbers from a a bit think had standpoint. They COVID. still on effect, little still growth depressed of beginning probably a of probably a of was little regions

But I macro similar more talked all team. of little in all, probably that to in expect what the guidance, pleased see we do you'll bit we execution the about terms more couldn't with normalization. be a of

been staffing of normal think that a inherent the half, to U.S. true in guidance as that some and getting little just levels there from second our but playing the in and the I the see is have here not bit business of clearing in dynamics back normalization we'll same backlog, the globally. a U.S.

would from perspective the we first. experienced So relative in expect far business we've half to in that in a second a bit growth would the thus come what

Operator

the Piper from come will of O'Brien question next Matt line Your with Sandler.

Phillip Dantoin

and congrats This quarter. for is Phil on end on another the great for Matt. Thanks squeezing us at in

process. what the to how J want but the that for at far for is, launch available belabor to starters miscellaneous that I'm going requires I point docs laying early those are don't conversations currently get iDose, groundwork as here, XXXX an the trying been of And really as using Just with code?

docs might of utilization there? early that and works like what look aware are process So how

Joseph Gilliam

Phil. Sure,

couple think of I a things first.

not to to specific and received approval, that things iDose various yet aren't You can product. all go to with reimbursement those there iDose, how imagine miscellaneous dynamics the given really conversations the has and as relates specific it codes

The vast have before majority in capacity. some customers this of through been our

work. the and that we're educating prepared our go that will can of you Some part that getting through I customers launch than are All that, very better with that tell at for we others. is how as process them comfortable

many will do it themselves successfully. them of you to can see and as want expect, see Ultimately, it

walk expect of ahead specific iDose. a as on I it's than broader it do getting bit at of like knowledge we the today we're say. in to something to it -- basis. educate before customer-by-customer a and is based experience But themselves care in I is run their So industry that launch prepared they their to they take more But will upon

Phillip Dantoin

know you there. was I on check just TREX. development called impact adjustments I to some That's And think specifically programs. helpful. wanted heard I in there anything earlier-stage R&D. called don't if and out any follow-up just iDose -- out I then to And some initial one pipeline noticed I

Alex Thurman

this Phil, in Tom launch for kind is down have looked we our as which was position, at capital of we at we it sat kind to And our goes speaking we comment Alex. invest activity. I'll on looked needed that is at of pipeline, we iDose just that. about, what and earlier looked what

to to the prepare started fulsomely make more we've iDose I gotten that's order think really that. so coming for And than launch in and around up. decisions resources we've much appropriately, invest allocating granular those don't in

Joseph Gilliam

I think franchise that, But that of generation, of remains can ahead said extended but imagine you individual heard on continue and to steam specific reference just we've that the to sort priority Yes. us, top and first don't TREX a I not you for iDose we release forward move full any front. anything programs. the the portion

Operator

question line next Your Saxon comes with from Needham. of David the

Joseph Conway

on one iStent. This for is Maybe David. Joseph on

users? is seeing new iStent iStent of adoption for are infinite, In docs inject to traction the primarily adoption from centered Or current a you terms Glaukos? around

Joseph Gilliam

of put a context see we're of bit you got Yes, you're at. it going where little to the the Joseph, of to stage I think but that, always in

not if been customers the I expansion, happening majority, some cetera, think customers within for utilization, utilization, of that time. the stage, is Glaukos at majority that have this vast the et adoption, stand-alone

anyway, I and true how That iStent think it's these infinite. you tends launch with to things be

hope Now the will and establish well coverage, expand reimbursement it more, be that in forward certainly glaucoma continue particularly to product move should we community this received. where as we

made the the start devices a iStent tubes free. procedures they'll stage, and infinite other today, that bit obviously, And really hope -- their in trabs they the run you time up picks side for to little more that and work adopt to on they're at who and that, folks late-stage spend coverage as able reimbursement

Joseph Conway

sense. enough. picture question. Makes Fair a Maybe bigger

starts your -- you or can approved do to more the growing XX%. talked of the to thinking X% growth With get is? products Health business you kind to You reimbursement of would What profile about long-term kind say think could your Corneal longer upside specific, grow what have that? you that Is be today, as still glaucoma there term?

Joseph Gilliam

that in to so think far more we you first to a need there's will, the about single-digit couple business that question, from before the parts Health we expectations. business, franchise. terms a that at moment, upgrade your within half. high see what We'll encouraged to think bit we've of think type by I We're a little Corneal seen our growth different the that, if I growth of Well, specifically in continue

we've operating of business, on. number out embarking both is and importantly, and stage more say to that inside Health relatively we in we you're But The me, at. put question been it's sides versus our I still hard think macro glaucoma grow there small a matter, start that asking reality can think to at to international glaucoma, our Corneal about markets U.S. for that what of and we're the

benefit mindset this next care, about change When if you chapter we're patients sheer excited we're we relative cataract from the relative go. the very cataract what very think think to interventional where why setting, size combo to who -- you about in of drive what potentially means to as of we standard for of I the glaucoma we're and opportunity, will, and number the Glaukos it's the can combo achieve can that going

if And for as that same of I cornea will, us closer a in to represents closer and launch. Epioxa we side the on similar you and approval think hopefully get that type fashion, transformational moment,

trajectory We're like. us a I going hopefully And we much for as in So think that benefit shareholders. all you and here. lot forward of larger we about looks that's have deeper a optimism growth to swimming and ocean what reason long-term move

Operator

line with Steve Your the Lichtman of next Oppenheimer. from will come question

Unidentified Analyst

Steve. on Congrats quarter. Ron on the for is This

normalization you Just you in procedure guys, mentioned the second of desk, your wanted the potential to of earnings ask year. in half volumes

Following what may in backlog the on been the over first half. have worked

you're can guys a little from the the about hearing on about And So talk do backlog? in field front? bit are think -- we terms you what where that of you

Joseph Gilliam

ways, it's we're not from some in think what hearing I the Ron, Yes, field.

in hold of about from And our for so who of feedback simultaneously. this on in think last several retain and if a doctors and work both were that out was hearing we fair enabled, constraints a year, the calls, inability fulsome what we to OR and around staffing levels the base you doctors the and X it amount example, called staff have and turnover to field

You were hearing theme. that pretty consistently

industries And companies, certainly along, volumes almost broader obviously, and obviously is one. procedure the see we heard but landscape, lot corner it look still the more And across year in a turn of point at pockets, trends When it general, made in I again in feels macro think and cover quarter, around this less we've it's as been It all, think this exists that, the saw a you if different the second. of I'm have I into as less pretty we robust. we've and first backlog and less of like, sure and pronounced. and procedure quite we it the in the you frankly,

to in to MIGS been made work. that general, why first back our And whatever can't of the backlog exactly make in accrue like it does, I elevation making half. sense felt it the specific they're item way all to they've second the we it And whatever will that And I to or that any impossible in half normalize, tends it think folks their existed will point obviously, continue but benefits. may assumption in have know number exist. when procedures, if net-net, not their working or within to more that that, been And through way ophthalmology It's like through. feels

Unidentified Analyst

this? that one iDose. just late be for follow-up Do will any guys for called that think already is it panel Or to small And too on a great. you happen? That's chance there's

Thomas Burns

Ron, that I'm happy take to question.

before, few -- We do address is that been that an requested. asked times be believe panel this it advisory a but not So there'll again. to happy currently it's will be

And so that -- on going very moving PDUFA date, everything we're is well. track, now right our towards

we expect FDA expect as to well, next confirmation date. in a advantageous the is of finished interim hopefully needing we'll CDER, the us receive position CDRH well, for a just mid-cycle inspection written will some weeks. PDUFA questions, few pre-approval put a review, We And we'll going which very really which in went to file believe into that very, and a and the

question the panel. answer We no. your that expect to an don't is, there'll advisory so short be And

Operator

Gong with JPMorgan. comes question next Your the from of line Allen

Allen Gong

I been already. have lot think asked of a the questions

very think I product. predict just already. there The I'll I product But that comparable when but a it I kind fully So the about keep about hard competitive profiles to is iDose, think are success. one. fact the somewhat landscape, the to somewhat when on market it's understand comparable different of clearly that But the

that competitive about How iDose should that we differentiated as market solution. we see and a establishing it iDose as expanding about from if opportunity whether kind think a player, really maybe not just more early might benefiting secondary or dynamics from the is or of

Thomas Burns

endothelial months, well, see no [indiscernible] limited where Phase X% the of we that high to a and XX% relatively you've you've versus to endothelium patients to safety endothelial clinical a period which is time, showing and short happy in product something as to you we of seen X answer cell a have just rate minimal hyperemia I which product its towards. relatively of loss relatively a will. this, due loss, off I'm take use release cell throws its is lasting rate shown onetime is But or I that IIb years. Alan, really that DURYSTA controlling as product hyperemia bioerodible, dosing got that use tell have, lot of what first has of mean period Joe a see a that in a profile is glaucoma and rates of of restricts in don't would high I Well, trial of that of X as as take would the profile such part you I and basically a that we comparability a

And DURYSTA so a between use of, X see don't comparability I products. the I predicate. a don't take a lot of lot as

least X think limitations I of with that therapy, I even our $X,XXX you tell there into where concept for that Joe? a these J-Code some has going is limitations think might serve serves relatively intracameral DURYSTA I us did the given a at this some will well for they the establish DURYSTA for this, pricing appetite, optimism fact at of I interest that drug of delivery. of place, product. high will the the in , been draw strong months

Joseph Gilliam

iDose launch, add, just X the think DURYSTA in the Yes. I not. one, things specific I'd us that one benefit

positive. is mindset helping I think anything a today that's drive interventional that glaucoma

alongside in about Allergan standard you efforts DURYSTA that reps muscle the to change As and we're we out all that talking and that have as know. we're of putting their the that that, fact been about think that continue care, driving in of behind

continues course broader industry that I to think think optimal is towards of what care patients. the we hopefully for turn the these

obviously, it's about any And competitor. the second thing is, less

to lot that through that of combo reeducating around setting had the a residency. cataract hadn't of the with Glaukos more in blocking first to industry you even think lot -- techniques surgical the and a surgeons and it's iStent, the teaching back and I company go there tackling basic about of when since think just state were them MIGS -- launched done the

go various technical that the based of surgeons angle it's good more fulsomely or into the infinite the iStent iDose, whether And these and now is we new so any understand as much things, surgery aspects. news

features that benefits, And more Tom what and so product safety for use talked is the the it's are the case about as that profile, and the label. patients much has on about individual appropriate

a into So that part of think it I and in we we're - marketplace enter do drive going faster. to more interventional educated our even that with to far terms forward obviously

Operator

the Anthony Mizuho. question final will of Petrone with come our from line And

Anthony Petrone

the a here. wondering One could across year. procedure space. any up good mix next Congrats year -- views MIGS on MAC if core quarter just next have it are non-covered on X into Maybe quick become on how I'm if shape territories a procedures you ones. is non-implantable certain

do you space if that out? how the core see So evolving scenario plays

from second in there on iDose? Is note how then duration the be label just would of quick can label. And just on for the real anything latest the what about and the Glaukos one of on you're implant duration thinking views be iDose included the

Joseph Gilliam

iDose. part Tom around then in second jump can and the start I'll Okay.

guess to if out, relates coming so proposed factors could it that to this the in sure at would months, hazard things prepared LCDs play quantify it quarters. as scenario any I'm different many that emerges I outcomes, are the attempt for there as and -- not these there finalized think we're nor and stage because I a are not hopefully

focus a And building and clinical market payers patients. benefits surgeons we that supporting and regard. that is not growing Our decisions in making is on healthy optimal think

that I than all the of is right, long-term appreciate and future you infinite And agree at end question, that's we far our while take understand I interventional our and to would think day, think, really, focus dynamics. material the near-term where is view, so those more probably I iStent if getting the iDose, And a glaucoma, at.

Thomas Burns

to address I'm part question. your second the happy of

would XXX(b)(X) glaucoma So intraocular path effect patients. that with that we regards pressure in to say expectation regulatory would our reduction likely open-angle and a the under label, be in hypertension so of the I something label for are again, and ocular the

based X-month label We extended be duration. our primary that really significantly which we expect the specify endpoint established wide a to efficacy non-inferiority So open the the label, pivotal trial. do not will in on

be X in Phase to us the the study for cohort after That proficient that able -- both component, need did with the will become X and IIb payment. extending study payers important will the X-year years. coverage IIb to I think that, Phase to we For we've substantiate approach been allow

Operator

back I'll any for closing company over now turn remarks. to the the call

Thomas Burns

today. everybody Thanks, in We continued Okay. your all goodbye. for Glaukos. time Thanks attention interest support thank your and and to you for and

Operator

That will you for may conclude thank all and call. We now disconnect. conference joining, today's you

Glaukos (GKOS) 2 Aug 232023 Q2 Earnings call transcript