Earnings call transcript Q4 2022

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Operator

Welcome to Glaukos Corporation's Fourth Quarter and Full Year 2022 Financial Results Conference Call. A copy of the company's press release and quarterly summary document both issued after the market close today are available at www.glaukos.com. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. [Operator Instructions] This call is being recorded and an archived replay will be available online at the Investor Relations section at www.glaukos.com.

the Relations to and turn President Lewis, now Investor of Corporate will call Chris over Vice I Affairs. Please go ahead.

Chris Lewis

Thank afternoon. good you and

summarized me on and Filings the Summary. with titled accessible make. and Chairman and forward Joining This quarters, may Financials of the to Glaukos and we a Tom is objectives posted prior Relations community document are President a any Quarterly website the the has Burns; the associated document strategies or Similar and to business and section COO, state Investor Alex Quarterly CFO, CEO, Gilliam; Results easily provide company document Thurman. facts investment details to the that the reference its Similar company's guidance statements Joe and today with designed key quarter, under

designed regularly the is investors document scheduled earnings to be by read before This call.

To transition and opportunity remarks question that As and make brief we question questions, yourself such prepared you session. ample follow-up. call, will request limit for to into a we address everyone's ensure one and one time this answer to and

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

among about activities financial that and plans, of expect well may this and expected statements made reimbursement than of Please our call pandemic and things: position, strategies competitive and our the our the our development and business the products, statements future operations. products, sales, future developments market other in our regarding U.S. pipeline believe occur efforts, the our These commercialization, or technologies, of current as facts statements that condition efficacy operations, objectives, statements. of historical international on market impact and all note results integration regulatory COVID-XX as or and include other anticipate for or products, address events we on will forward-looking prospects are strategies

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

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

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

Tom Burns

sales net thank of XXXX reported Okay. Chris. approximately us million everyone net Thank sales to Glaukos million. joining Good Today, today. $XXX $XX.X full of and and you fourth approximately you, for afternoon quarter year

steadfastly recognize I'd like glaucoma and committed who face work. across and to the solid reflects past corneal our proud the our range will in Alex net dedication more year our exchange currency and a later franchises their outlook discuss challenging We our I'm continued also latest and results the of macroeconomic our our sales execution in introducing exceeded the of resiliency initial globe, around in a on environment. reimbursement performance expectations to foreign as guidance in the of XXXX headwinds results of health based million rates. Overall, million call. are financial remain to $XXX $XXX teams detail this

expand in and our including International and XXXX. face technologies, iAccess, program showcased and core we novel infinite. Four, developments. of Phase R&D we submission. advanced Two, achieved to highlight strengthened iPRIME for with minute U.S. the combo-cataract programs positive businesses. Three, a Phase data in the of franchises notably our resiliency take headwinds. I iLution One, U.S. pipeline, Health of we most several imminent two we near-term reimbursement grow Five, be iDose the to Glaucoma glaucoma with and stage basis earlier progressed the the ophthalmic other of Corneal continue accomplishments an iStent we TR preclinical we significant introduction top some X line X studies our with NDA key will franchise the our commercial that

global our support we pharmaceutical our with finally, in innovation of corneal and goals new growth manufacturing our of our hybrid build Viejo, campus in to our And headquarter outside expanded long-term operations the state-of-the-art Aliso and based center Boston, San out Clemente. facility infrastructure

line we us about top XXXX the pioneering Our portfolio as leave our positioned our fueled in to prospects commercial glaucoma next the that growth sunset excited will combo-cataract XXXX. position and combo-cataract the beginning related the years execute for achievements strategies CMS XXXX, our continue in year of ahead. resiliency this headwinds a we franchise journey in From and phase and of U.S. sustainable well perspective for our

the disease mission iPRIME our coverage opportunity standalone advancing time. we is are to infinite, founding which Alongside in transform will Glaukos, over intervention earlier therapy MAC iStent greatly payment. at efforts, and progression, the our parallel, glaucoma of which and increase pending for market glaucoma by turn treatment our establishment combo-cataract we In driving in investing anticipate latter

Glaucoma XXXX iLink deeper in International developing remain remains by in While continue penetration, we the for versus our important initial franchises, and and Health beyond XXXX revenue MIGS have plan prospects to bullish these our these prudent businesses Corneal for driving contributions are XXXX on technologies Within as globe. we the long-term uncertain. access and adoption around early and efforts, and we guidance remained our

great evaluation technologies pipeline progress have the made the we we successfully continue removal advance a iDose, in fundamentally submission which iDose and regulatory our that track delighted company over market markets announce a our trial, the year, also original over robust administration commercial clinical and core While demonstrating significantly we execute safety and platform were upon with for to believe of to implant, of profile month. for and invest TR these preparing our to exchange second TR our on and TR our strategies the addressable we the included favorable have are a this time. promising Earlier with period. novel, our ability teams Starting for results we development expand transform NDA and iDose XX-month iDose TR franchises, second this of

of exhibited which in greater than to results NDA This exchange body cell our endothelial to market-leading trial over more patients on Additionally, the period XX% time. calculus to competitive than our of Phase evidence support look over technologies the the years extended best-in-class redosing loss We over augment including powerful no the iDose further a other data the will dataset X microinvasive average. subject this forward benefit-to-risk evaluation in for adds upcoming supporting and safety tolerability clinical alternatives. of our five

preparation commercial functional team iDose underway NDA and also for access a commercial our next already preparation targeted launch well with to addition the iDose, in we TR across market and leaders our year. the cross organization for of are of planning In

corneal Shifting pipeline health of gears, positive clinical announced programs. we updates also recently for our several

confirmatory the next-generation cross-linking a First, in subject enrollment this second trial for X targeting therapy we year. are keratoconus the of for Epioxa, our corneal completion end Phase commenced treatment by of enrollment and

therapy, halt or As with slow keratoconus treatment of serve we and keratoconus. Photrexa, our first-generation corneal plans for patients progression Epi-off, remain the Epioxa, cross-linking our the remains FDA-approved to we advance clinical only well-positioned to which shown

Second, treatment ophthalmic be our we to Dry topical clinical cream is to results first-in-human are applied Phase on and promising the encouraging for Eye Eye the trial this eyelids of sterile symptoms the of trial the iLution program. later a announced GLK-XXX Disease. Disease Phase Dry year. a planning for GLK-XXX for we to initial these from Xa observations, Xb GLK-XXX, signs Based commence

Xa conditions while monitor to We presbyopic our program, we GLK-XXX, with evolving presbyopia available therapies. data iLution the Phase also are associated market continue for closely the evaluating

now we pipeline label pipeline we over for study infinite. a are first-in-human also to several these a IDE Travoprost, retinal addition anticipate course expansion and IND iLution in the Finally, including iStent open trial – milestones of an XXXX, developments, additional for

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

from in So we that truly platforms at Glaukos mission diseases. sight-threatening is do. meaningfully core can of suffering transform care to everything conclusion, standard novel, pioneering outcomes our of eye Innovation at the chronic patients vision for dropless the and improve advance is by

through infrastructure, treatment push Our our quite chances I as First” the our retinal mantra glaucoma, “We'll has take corneal commitment legacy plans paradigms been of to to embodies and to limits we the aspirations. and disrupt technologies. stronger never people, determination execute future our disorders and and game-changing never promising. confident our our deliver I'm diseases believe on to strategy, balance of science in pipeline pursuit and have sheet Go and the foundation our prospects right

briefly that, with call our I'll so to And forward open the discuss to Alex outlook.

Alex Thurman

unfolding how I'll our believe few are Thanks, make for on a XXXX. now opportunity of today things an Tom. we markets, and comments state the

other combination-cataract to surgery volumes cuts First, fee continued alternatives. of the XXXX more takes related impact glaucoma net professional our $XXX initial to on for $XXX million million U.S. sales account invasive bypass guidance estimated into versus reimbursement trabecular

when these became of initial changed physician effective, the not cuts January behavior marked While the X one. anniversary all

and assumed earlier, commercialize And dynamics this the of Tom business and technologies, of and bring modest interventional Second, mentioned stable we cataract VIX continue to competition successfully our areas, the across while point at contributions to remain pricing therefore, our third, ability market broadly major our to largely early expect have combo we glaucoma more each in newer as stages, year. strategy relatively remain globally.

for half contributions While be versus their weighted be newer bullish year. technologies, the products to our more over we and assumption of is the second market these time, on continue our opportunities to

questions. I'll with to Operator? that, And the call open

Operator

[Operator you. We'll from Zimmerman Thank Ryan take BTIG. first Instructions] question with our

Ryan Zimmerman

question. to honored Wow. I'm first Thank you. the ask

is want couple really of a I meaningfully XXXX. this coming focused the particularly of think, of out on questions, the on So to to for be guided call. ask for I something, think, We're tonight's just you I guidance, looking guys Street where going ahead

easy physician stable from not past and I appreciate Alex, dynamics, that comps coming year the behavior are year. this into you with reimbursement comments. changed, And But appreciate I all those

mean – through in how you're you pain how so change, go right? through I view? with components of market to base to customer reimbursement cuts have does two terms much these behavior I more in And glaucoma physician question, of this the your much do the how think guess

very has gotten more large obviously sales from want it's the but a a competition in also of competitive And admittedly, on been I material because to here Hydrus force. competition hone player a with while, major for with introduction

is So that as your much how guidance thinking minds tonight? about you're weighing on

Joe Gilliam

Hey, Brian, there, Maybe I'll the question. appreciate it's Joe. off start and I

XXXX, have think, speaks sales everything as setting that, to somewhat entering expectations strength it in the of we are expectations the as to to not think alluded want it on CMS in Tom performance as currency ways, commercial cut look really may our it about if walk of we right? one back even said been products, really year want to for to But organization we run to as you our specifically. given constant nearly related before we fairly surprise the and I flat others on best in our a own You and that come team the You from years, to that XXXX to, faced. XXXX, the XXXX, headwinds basis, many relates of XXXX it – may proud a that our significant our and really investor as finish you our

seen as you've we though the to As the headwinds those to slowing alternatives go in CMS combo to invasive year, kind competitive dynamics. course at saw customer more away. slow over that, in of going some Obviously, where slow. impacts second those those of We considerably. base next those And once. slow the I going lap the expect think But and do physician we selling does even context about to the that necessarily down layer of expect behavior of do in economic question your based cataract last of we setting. expect into trends half that we that candidly, XXXX, were the of and change isn't the do all not of related stabilized But

as still you that think there. unpack I further, it's

think the are competitive that. intertwined I dynamics in

we battling I against a it's we have dynamic necessarily think every in Hydrus were are That about been describing. that Hydrus less product Alcon the the you're day, today. We and on while. has for past,

are had economically more course will that XXXX there year. it's tailwind of of think more we've to and related the I about cuts this that course the sunset how procedures CMS that over a experienced out over the advantaged

take amount relates of And into to I stance as to and XXXX, think the we're stand though we a that that even a trying fair to activity we relates confidence term. we cautious how have long as over it enter medium

Ryan Zimmerman

Okay.

to canalplasty expect market, to the a assume in – One, you canalplasty, bigger then advantageous. that referring a do to ask that to and these year? procedures expect to parts do follow-up economically to again. shift you want but you Just referring the I market are to are you are this two shift

that, and is lost question come my And thought. of let I with me But back, of train then second guess. start I'll the I component my

Tom Burns

you let go anymore. to going not We're first Right.

two got questions. You've two-part

Ryan Zimmerman

the Yes, all to in part. [indiscernible] first really

Tom Burns

No.

relates more invasive in it canalplasty, et – So as I'll think the goniotomy, it together I first cetera. to lump

pieces think call is two it. would I I there there that

to one I The first just is similar what said.

what it initial dynamics experienced part – we we the is. be less a expect a think with really the to in of than the in and bit we quite resulted disparity those. matter CMS I as associated impact what economic XXXX the that as doesn't sort of XXXX, relative sunset cuts that Obviously, technology

at is, potentially as or successful with know. they lower those as being that iPRIME you the even Glaukos whether be a technologies, customers price right, second and iAccess, piece ourselves, other point, But that we're maintaining obviously come

to respects, things the thinking to some relates Glaukos all as about specifically in you those XXXX. entering have factor it in into you're so when And dynamics

Ryan Zimmerman

then part I Okay. And of remember my the second question.

you about kind apologize. or I and to essentially corneal growth the split teens split from growth. just taking for maybe low can about contribution where we When single and the And It of of Thanks business that the digits flat. thinking So health in high implies glaucoma amongst I'm your if going mean think squeeze of of segments. the glaucoma sales that Is between in I for I guide, your it about Chris, questions. lands. here, terms even corneal exactly this think the to kind you're year way components a two health hairs standpoint

Tom Burns

of Thanks, high start to corneal some have single-digit your of others place Ryan. when is I'd ask. color say we I'll the the business question, a they for expectations, type broader the save health to for reasonable growth. to But point probably estimate

means international can glaucoma growth. the the double-digit course over flat and glaucoma, we'd of side On a math business of low in expect what franchise the do type And the U.S. then that XXXX. you being on for around obviously,

Operator

question take we'll with Stephan our Alright, Tom next Stifel. from

Tom Stephan

questions. Thanks guys. the Great, hey for

remainder rates date with the or I Mac the up Tom a think I'll start for made can year. fees of the off Joe, if Actually, a about bit with XXXX attractive that you thoughts picked again, your a talk in coming progress some you've establishing Infinite. the mean but think even We maybe to what expectations and we Pro and pretty from think, if with progressing XXXX those could efforts on, are out how I and bit? for already, bit Macs, maybe love would

Joe Gilliam

I'll Yes, largely pieces. off, break infinite related Tom he Tom. It's to thanks, conversation and add Mac some wants two down can. Joe. start I'd if to color, the

probably no far, you for lot that to what is as about of know, early. can time that we're first talked statutory nine-month some count there coverage progress. on it's a of on we've And there as we're I the just making there. track thus and is But still can a you And lines overall The is tends procedure. the to say be six- And now, time process.

every those hard that practically working – to coverage as we're to possible. day policies try as deliver soon So

the you're over and been as I as specifically, Pro has for are in the are think, right, open they or it early, think I volumes early coverage you can time, range component relates know, have it, change those you $X,XXX the whether policies call points as it's data grow. fee. again, But as to we'll ultimately Pro fees of the that there that been two, referenced,

encouraged play of So by think early a there. I we're data but lot we game points, there's those

Tom Stephan

back my we products thinking you around in were And be or have tailwinds come iPRIME about think new XXXX, that think greater front. it, but that's should XH sort then it how Great, XH XXXX, [ph] But XH? Joe year? XX%. versus I second I and XXXX with be fifty-fifty. Infinite being I calced of and helpful. likely contributors I sales to closer just think to on was In would Alex, FX guidance. then And seasonality one XH this

for models, greater in those go splits XXXX out XH our little maybe of we XX% less where is as So a to XX%, XH type more kind the we level. or that even it's back than levels pronounced, build of do seasonality

Joe Gilliam

Tom. thanks, Yes,

couple think, of seasonality I obviously, in pretty by have COVID trends last dynamics. disrupted the COVID-related years, and normal the been

So we something I expect from back underlying to more a should expect that perspective. get an enter and as little seasonality would we we would XXXX, normal market

some fourth times and referenced in little the to XX% variability second be a we’ve first on third, calls, prior quarter. those runs XX% quarter, typically, lot of said could a this XX% the there of there XX% numbers, and like to and I in the XX% You market something think, the in but

particular. than for bigger about it little market I our half expectations you may for underlying iStent think the half year, versus cadence a product that seasonality. may that driver it given bit, if first specifically, for And our second Glaukos think play infinite amplify specifically the frankly, may us just a quite in the seasonality with

Alex Thurman

question FX the you. for address I’ll Tom, then And

well. year. for we will be rates think, think So, relatively FX that we’ve our overall neutral we And again, as the on overall, sales the kind of looked at

us a to the a half. will do first and headwind believe modest in tailwind we the second there However, half in be

Tom Stephan

Got it. Thanks, thanks, Joe. Alex,

Operator

question our Biegelsen from take We’ll Larry next Wells Fargo. with

Larry Biegelsen

for taking Good afternoon. question. Thanks the

on infinite, one cataract come fees. I’ve two been which about procedure. which $X,XXX, have MACs the is that XX Just follow-up is physician with out

other to update and question stick? follow-up. do expect pay And the do issues expect that MACs you the added I X the supply is, you any to So iPRIME on And about same? just

Joe Gilliam

some is off come start to guess will MACs time, would Larry. Thanks, their I I obviously, for a We’ve don’t this think fees. as I’ll specific on where procedure. individual said the pro on hazard out a stand-alone that.

when framed are one procedures the And terms at go surgery. in we’ve you points end so the are that early out even you there data various And where surgeries above these two there, obviously, standalone come look that of cataract glaucoma out. seen

lot outcome room So, a towards that range. there of clearly, higher fair with believe there the of I discussion that for there’s in end the MACs. And think the we is

on working we really over time. and see with time, about part since you – commercial our that think of last a growing iPRIME, we’ve our been May. pains through a our over continues. chain And that really portfolio opportunity customers as I product supply the asked been like now we’ve product and with growing and optimizing But

Larry Biegelsen

And in to XXXX. DURYSTA? be According pricing They relative ramp think AbbVie, $XX think slower to approved my at they during about on million faster? derisk Thanks. how any Do I’m for thinking curious ramp thoughts the post about compare COVID. Thanks. were launch. you’re will you And follow-up, or time did Tom, same to how on will iDose. just the the you

Tom Burns

Larry. address it, to Yes, I’d be happy

said I an establishing get X designation. professional the of signed reimbursement we’ll under think establishing will means a It the through before, Category to have a the fee and normal for that APC. go I as product, the mechanics

months. a after takes code, normally for soon about HCPCS filing six And which we’ll launch, be

second of traction product where And a we’ll the so half what then said kind up strong received beginning, be pick will from look XXXX we’ll adoption. this and see believe to is really I of the I

predicate I in don’t believe I a would adoption. use as of DURYSTA terms

I the invariably board, these in look when are think how products almost they I think, compare, such you every across category. different

would the say balance iDose. I an tipped think objective most that observers would be to

amongst fair that is along. And done In by would some is implant. Allergan of What what to biorotable would of be believe four-month our I given a in I’ve comparison would basis. three-year think all on just that you achieve code guess say we by that what the Larry, they think said the able I And this that so a a has pricing I company you’ve be you for seen HCPCS marketplace. others, would will data, price floor means service give that, in we establishing fact the case, believe what the our absolute

kind transitional burden a before, you studies pharmacoeconomic caution illness that launch direct things Again, investors position assure can in pricing. proportional we’ve the probability with any I we’re analysis [ph] of the product. well, done analysis mark the establish all behind price following a doing that we’ll of on analysis, to scenes, analysis, doing including I up of done prominent cost fair and I quite think quite be multiple

Larry Biegelsen

All right. Thank much. you very

Operator

Our question from Sellers with comes Stephens, next Inc. George

George Sellers

expenses for to associated Hey, of that expecting Epioxa with study you’re be confirmatory the of operating additional this I question. guess in and taking may year the maybe changes iDose. the some start, you expenses clearly thanks the there’s with terms been

then expected required maybe approval, device? as year you if some I’m just that of to So the commercialize you iDose this and that on the invest investment subsequent start as you cadence also through help curious ahead to could

Alex Thurman

I’ll You advantage give And bet, you to more to take actually, the for Happy that. models. little all the George. a do

in So, kind of terms about OpEx overall about of think already what kind P&L. and talked you if model about think the XXXX We’ve and of to and revenues.

our XX% If our the profile that range margin, done to we’ve about should you continue historically. XX% margin same in think

part model. So, with you to the confident should feel continue that of

about guide means have XX% in was that $XX ballpark. a be And pull about the excluded you under would normalized $XXX growth, the leaves expenses in operating IP take and just we if expenses, which, you our think you XXXX would a XXXX. out you’ll is I million normalized operating when And old the anyways. that rules, R&D of way assume then it to expenses, with in operating the And for I kind million about total say that

just then got lastly, while now I’ll right the I’ve And phone. it mention you on

next year, And It’s going model posted that XXXX. as bit come should range probably around you think to of for you you next $XX we a in about CapEx That number year. should come in the of in help million million. XXXX. If CapEx in $XX for

George Sellers

Okay. Very And for as helpful. Thank you that. just follow-up. quick a then maybe

to back little from Is the guidance Turning iPRIME the color terms iStent that a additional contribution could on give infinite bit. any of what in and year? there assumes us you additional devices, of iAccess, this

Joe Gilliam

It’s modest But really any that George. glaucoma – business. fair Thanks, haven’t the Joe. product I particular, our to gotten contributions individual franchises, think to We of it’s the granular with U.S. Yes. respect to driven one that relatively in over can by infinite imagine and particular, drive all that the XXXX you course and in MACs. that. turning of a say on iStent the grows factors really it’s But contribution those

George Sellers

Thank for time. great. all you the Okay,

Operator

Blair. question comes with William Our Margaret Kaczor from next

Margaret Kaczor

wanted taking guys. afternoon follow I good Thanks iDose. question. the for up Hey on to first

maybe to start guess, combo then designation, cataract comfortable stand-alone stand-alone get they market? profiles, are maybe the eventually or surgeons little compete Or going it’s coexist with And different in a profile – bit, go like or a guess, that you accelerate do commercialized, are a different most DURYSTA? the a to expect, we patient going with given patient You it kind more it’s can you other? it something referenced assuming is the I to of off Once for they but setting each XXX(b)(X) I as deeper. little

Tom Burns

it. Margaret, happy Yes, I’ll answer be to

pronounced first marketplace that to that the the currently I of demographics and to target candidates what DURYSTA be that some the do So is think we’ll advocating. we’ll patient will talked I’ve the before. I all, seeking entering people believe be patient have about advantages similar

again, as think, objective with you’ll well. observation find checks, and any I channel your that

when adoption. think this classic some see launch do I we think product, we’ll I

I this combination be a cataract will think use in with towards movement strong the surgery. there of

alone perhaps I to to surgery, surgeons with combination in in be think product able like where the even cataract or infinite it’s combination medically either place deemed a natural a able iStent with be necessary. this to

and look to see a be believe before, on in able And parallel to being that at are who look option build medications. option of areas where the able Pac-Man are we’ll a glaucoma. huge that the ocular multiple approach a burden for in what treatment to We’ll will between to for kind for There’s surface treatment XX/X compelling – surface disease. a and have and look of noncompliant They’ll ocular patients glaucoma underlying disease thing do to the by stand-alone marketplace. provide eye. want to clinicians want targets on a is to exacerbate with as our last the patients do But patients who I surface as condition that reduce do of will surgeons multiple the there begin to I the is continuing said be adoption drops glaucoma dose comorbidity preserved typically people

the just burden the to those can or substantially and burden to from of to better resting moving rate see glaucoma we forward. every we to IOP one two control surgeons will free, three the to drug also time make leads want then of medication reduce in reduce that increase two or We’ll which our patients, compliance medications

there quite superior these they can a alternative. in will I we potentially Those side, patients. or are phakic the do, start once two we'll believe have look that surgeons then patients and groups that stand-alone quickly move and undergone to we'll legs superior there first, many see suspect treatment first. on for able patient get and want a And and patients pseudophakic have to to they'll be into cataract they want already those surgery,

Margaret Kaczor

you guidance talked Okay. of That's very there. helpful. recall Thank you. And then just kind But I the don't and about puts a question. about We staffing. and the bigger picture macro takes talking

are that is a in a anything guys now in you are headwind? here Thanks. more it we XXXX? normalized environment recently, still So Or seeing

Joe Gilliam

industry, think dynamic is in think much not I throughout I the care hospital remarks. And of Margaret, it's probably document in to those summary what terms a it's a not as ophthalmology experience staffing, other both We ASC Remains hearing But immune folks as the in it health hospital across you're not and well finding play, both No, there. challenge, probably the a in the in from I prepared our quarterly them very administrator still setting. and practices, that's staffing think retaining right? turnover. may have folks referenced

successfully the that or You down. turnover think hospital and them required that's to in expertise ASC operate an slows about

So much absolutely we've going remains. but that what through I we been feel to with COVID, dynamic relative XXXX, all into think better

Margaret Kaczor

Okay. guys. Thanks

Operator

We'll with from question Winch Joanne take our next Citigroup.

Unidentified Analyst

Anthony for Hey Joanne. is on actually this

one have First quick. is I

that's label follow you the for details any up I follow-up details? could had on there And size. are any Just I Infinite then extending provide a after? IDE like the trial just to

Joe Gilliam

first on the infinite Do question the want expansion had was that. to? you and the trial Sorry, IDE, you

Tom Burns

Yes. to cover happy I'll be that.

to we're planning treatment FDA where So that to the meeting we'll is, what to be short expand and develop be protocol do be a in we're on in able a will with to IDE order, the going the labeling looking mild-to to is under fact, have earlier claims glaucoma. algorithm surgical medical iStent adult moderate our of And to failed patients labeled now we'll therapy. in which for open-angle interventional with look right and to treatment infinite, patients move who on an

at later of looking be and already to just to with meeting have kind our mention, year. begin shortly, them trial prepared look this we'll I of prowess we We'll FDA. should to that So be portfolio. the approach the our the

be be with IDE not infinite important only moving mentioned I just with We'll think that that this opening. iStent we'll forward at year travoprost's. it's looking I mile-to-moderate alone, dilution

strategy the As regulatory FDA IND We'll flow be there. an IDE we've you pressure command an with from and taken open device to meeting the clinical have full of open that the for Santen. now know, up for we

based dry forward with iLution design. significantly we Phase early eye results product forward the Xb a achieved We'll the be in trial with Phase X moving axitinib early on powerful X the and design be program. of retinal Phase We'll the with moving our

to so And from so many to planning here period. on, here so things up the start we're this there during labor this much some going is hood under see good the fruit of certainly going and

Unidentified Analyst

improved? you Can in called what quarter? just than in Great. came And maybe I reimbursement we talk reimbursement some drove corneal That's health the stronger quarter, you just on quarter know has if And were out about then the helpful. headwinds. last modeling. that strength in

Joe Gilliam

Yes.

I time to in you see the Where this a volatility increasing obviously, in landscape. customers we treating seen be think as conservative react about under had they business some we've in more and particular. that bit commercial plans. various And talked in corneal about the the tend health whenever U.S., for these payer think patients

middle year, access effort about. that investments muscle last and of relations we really payer part talked market the put a other into in organization more around started to our our lot we So

million. were and Photrexa on I was $XX the million returns And And in of we've more saw little fourth the sales, record north the seen of quarter, I you I that early quarter think as a think exiting good those in we investments. $XX a think year. It strong sales

So encouraged encouraged. we still in and deploy we as results quarter. certainly were the been were It's we've early we these the by making, investments efforts but the

Operator

Piper question Sandler. All right. Matthew And from take our O'Brien with we'll next

Phil Dantoin

for taking Thanks Phil is for on Matt. our this question. Hey

horse contributions and don't anything, For starters, puts dead from can takes modest want and to be I products, and that's from a you just guidance, iStent only including on new infinite. namely give your but or

PFS to I year. first [ph] the expected think had securing But you payment process benefit past thought and the has in this of previously than you've reimbursement garner [indiscernible]. half coverage through

Joe Gilliam

I the got. you've whatever the talked about broader guidance, you yes, questions infinite cover when on Well, could component

rely we I we've time There can process. with can I experience is only said rely think earlier, for that our to you really on. nine-month products the a historically line a brought as while, is no process. MAC through this statutory said We six- the that on

we're process. We're track. progress in it's so good And that still making on but early far

relates QX, about as frame for more us I time midyear, which, sets glaucoma weighted the infinite as is down guidance, particularly starting that, of talked iStent up said, that lock something second on franchise. for to terms half means performance, what to really of it coverage in our the a we our QX we've out I it be in continue so U.S. to to track and And And there. hope

Phil Dantoin

we my iDose, of gave XX-month kind do time submitted that XXXX for really could last into And then when here? you that ask early-stage approval, expect – think approval what Great. so from adoption? one could early to to disease. as that but to I'm about should what targeting think hypertension this And I target approval? how bleed bit Great. know still too line being a just so might for the be you're it I late-stage initial well, broad, really label Or you've a here ocular

So think that how initially? about we should

Tom Burns

the first be It XXX(b)(X) pressure take label in hypertension is reduction or first and for part ocular the me The your intraocular of second glaucoma. Let the designation. will open-angle under question first. of part

we think and several invariably target the patients. will us for adoption So market the for sophisticated we a the label which and achieve can wide, we segment allow best love It to reasons. earliest where in way is to

In will we month the a FDA the is of And we imminently. our possibility, be will approval filing which date always and not they filing for NDA, things as terms change believe are to targeting typically, commit do And happen. date that's NDA that what I It happen clearly, FDA approval, approval that the your the of for be the filing in and this we that finish of PDUFA a said end year. establish – will XXXX, target one continue statutory process to before the it's move but into product. the always to will

Phil Dantoin

Great. Thank you.

Operator

David Company. We'll Saxon Needham & question take our next from with

David Saxon

glaucoma. to last I share taking lost the mean, and lot with a start of cases. Hi. obviously I'll Good Maybe Canaloplasty afternoon. questions. you for year Thanks Goniotomy

iPRIME Are wanted bag? in have half? platform, back why just especially how the come the thinking the ask you're back there to that you the would any opportunity share recapture ramp we to continue lost to iAccess docs more given products reasons So I now about in and to that

Joe Gilliam

I were of I proud as how to it think I I to when it. the commercial expectations speaks really of our turned earlier, to organization. on entering said mean strength I said, back be relative things out hard as Yes. year, it's think as we And this we look not our products and

iStent same in best-in-class what continue providing customers that hopefully and to benefit for us to infinite are to we and I on been as journey more think through really our alternatives add those customers things have think we time. products XXXX, we our continue these a access here long will

think that and beyond. from I benefit that just stand XXXX that, the see we so impact not in ultimately of we'll to And XXXX, hopefully and but

David Saxon

larger you you. And from. mean Thank imagine we've some a I Great. large then Okay. which companies about heard benefit cataract backlog, talk I

guidance just assumed maybe in market mix of growth And potentially I much. that. above-normal on And wanted to terms seeing view what's your XXXX? So so in hear thanks in

Joe Gilliam

Yes. It's given always impact play has of that a in or hard when to out, things play any predict they of time. period much how that out, those how quarter

lot of question the earlier that to and ties the received I staffing we constraints some think that a of around there. back

group certainly a that we've of has their a So because or their continued procedures And out. scheduling backlog staffing seen extend constraints, to that's amongst of lot the practices of time pretty large of right? of

of OR out down they've tried can back bit in staff more lack they further. as cases, or them So normalized a many to turnover and slow schedule schedules, administrator little get to so staff

marketplace potential to is the it's think certainly harder tailwind plays that exactly I little a predict. So out to when a

David Saxon

you. Thank Great.

Operator

from comes question Oppenheimer. next with Steven Lichtman Our

Unidentified Analyst

Ron Hi guys. This on Steve. for is

looking about headwinds terms are then you to reimburses ask scheduled that But have gave I colors and follow-up, are any you okay. thinking And incremental you for that's Just fee wanted a of some in guys the already physician know guidance? that. if how if XXXX I last staffing. from about

Joe Gilliam

think staff new mean expectations glaucoma to coverage of largely our continued And CMS and pretty dynamics, cuts, launches question those. centered I Yes. for asking around the around any I and headwinds fee the additional you're some franchise. reimbursement product in factor is with think I our pro we've associated much all and the U.S. the tried considerations,

So are things effort of to we we've thing earlier, and see setting said it a XXXX. those repeat one I through run all really taken that of front I try that really those here which relates kind given in expectations. wrapped before we is as to to expectations I all walk into our think been will us, conscious we've what for

Unidentified Analyst

on people the Okay. if what follow-up really, but while, health just And really been it's for business, a asked before, it's can steadily hopefully and you corneal I not been great. guys, may exactly, growing

it and of at how it's trial you Just are guys your going [indiscernible] going terms are are for what at how much taking And on, thinking maybe enrollment looking up? expectations when a about Epi-on that it that's the trial second your of business? chunk Looking you how with bigger the future? in and that you finish repeat for the in for

Joe Gilliam

he that can. Sure, add, start I'll off Ron. will Tom if

returns as XXXX for earlier been single-digit think We now. of estimate in high fourth and reasonable about it's that talked type in been I to quarter. specifically on franchise, investments the certainly think call some we the the about we've growth making of some corneal seeing the early the we've health in

making of probably to gross coming of to about. think diversion likely be is little into that adjustment. our that enhancements some we've in in a I will net our co-pay Epioxa offset benefit a continue the that And to program, you've bit us trial should been by term the the year. And which short that It assistance patients asked

now for patients clinical been into enrolling think earlier trial process as said Epioxa underway. And that's we're fully clear, and Tom I of pretty we've that the

Tom Burns

I the study. the we only require would think out second from I'd make they is that's comment the found clinical that FDA

I enrolling in already think late it time we the and earth, in heaven was we frame, and October and moved January. beginning patients began

from we We the in moving end of And have dozen to in and committed sites approvable looking commercially of getting of XXXX. to the math target U.S. this end we'll there, the short couple up a by already enrolling we're have over the a and year. fully look enrolled And do XX having if the and product order. running by at

Unidentified Analyst

much. so guys you thank Okay,

Operator

Allen with Gong question We'll from next take our JPMorgan.

Allen Gong

Hi, I had one. just quick a

kind to questions But present more have seen of from I from been definitely beyond, see of the XXXX it and lot – iStent success infinite. form we've contributing in products of the in iPRIME, similar more lot the is shouldn't asked. a you've bit. and When be already XXXX, in when we products a least contribution think Why the little more iAccess been especially about a expecting on emphasis at category? putting which I comes those to think

Joe Gilliam

And Yes. to iAccess, mean iPRIME and I as think both year and we in the continue each forward we've grow contribution both from will move seen XXXX on. I goes here. right as

of that it we think relates dynamics this stage of just and game, at get don't want ourselves as the the there. trends ahead to too I it's to

and through alternatives we've XXXX that go as we us got forward. feel do make into certainly the of our portfolio will that we way they beyond. go and But serve As confident XXXX well

Allen Gong

it the your invasive a Sorry, you're continued a have it impact hearing impacting to follow-up. techniques. especially may tired but it, it be the quick on sure in how has have of noise of when your any to and more going bit Do forward? here, landscape comes just to own I'm portfolio competition could reimbursement about slip you thoughts how that,

Joe Gilliam

as parts been to the it been long some a I happening whether we've it's now think – goniotomy don't to know the it's alternatives going obviously was reimbursement how part be to our the category that on or relates lot record for landscape there the was of respect whether or and codes whether or I X various going conversion with in canaloplasty the between. saying of trabecular that moving of evolution all with bypass through that's own it

it algorithms I the from own think to landscape reimbursement standpoint. of continuing look portfolio. are having from around the our think When payers and that's the a what at I is refine their generally that reimbursement standpoint, supportable benefit they

tools payer meet we the have those that need patient's And individual depending MAC the the algorithm hopefully, patient so hopefully we to or have these importantly, that of surgeon’s And that all the or are surgeons. available a solution can algorithm. upon – that most or the

Operator

next our on to Group. right. move We’ll Mizuho question Petrone from Anthony with All

Anthony Petrone

standalone? should I'll X have line just pricing? assume with And I'll in on versus few think gets cataract certainly, start fees favor then your if of MACs the about a the a should would years you we infinite, first dramatically cannibalized Thanks. we do over with then And cataract combo over if physician how playing have on next in come secure stand-alone that time. And improve follow-up similar in, where follow-up curious infinite question combo that and iDose. iDose. actually maybe we on a And out

Joe Gilliam

I to it's really is a is expectations, one at the come would Anthony, as least trend much they're more for I patient being that significant a out The with forward. going call is visit call decoupling if some I is cataract surgeon partially know glaucoma, a don't versus us, that, would trend of for occur. may treat may Yes. I still treated primary that patient that and that likely it, which one were think both I be at the what same that but time, don't think in handle as suggesting that's There out. you the really

truly founding since can What I stand-alone these the patients is terrific for we not. or really our got providing is the whether think of which irregardless more talk Tom intervene our patients. interventional of to is we think manner focus start behalf in the company, on cataracts that drive treating we're solution a something that's what focused for at surgeons a And they've mindset of a where respect with on lot about, idea these glaucoma you've the really is and heard is iStent infinite of

Anthony Petrone

direct a reimbursement when Arista. helpful. look but And PDUFA That's at then we have date? we AdCom leverage also channel, expect pharmacy. of we perhaps And on think specialty the panel ahead should office iDose, an ahead they to reimbursement, They physician

same should iDose? we the Thanks. So expect for

Tom Burns

think you've think how these I seen we handle with in the issues reimbursement, past. I

group comprehensive strong available. that's a have group really got payer market access and approach. a We've We

buy-and-bill you I purchase options available expect And is to going can to that procedure we'll you go a this for practices buy-and-bill in that the specialty through know this will have marketplace. pharma. to think and or directly both be

have a – full half launch, again through thought those to and launch XXXX. available sophisticated already beginning second we've in have very of ready, So meaningful machinations expect the and will we up truly a again plan

Anthony Petrone

advisory an do AdCom, the on meeting? maybe expect then you think committee you And

Tom Burns

not. do I

Anthony Petrone

Okay, thanks.

Operator

to question-and-answer company remarks. call to the And like that or over the closing I'd back concludes turn additional the session. for any

Tom Burns

you day. and all want thank goodbye. Thanks for you your and a Well, your Okay. and your wish of today Glaukos. thank We support attention for and continued good you for interest, time to

Operator

Thank that your you does participation conclude disconnect. And may presentation. today's for you and now

Glaukos (GKOS) 22 Feb 232022 Q4 Earnings call transcript