- Earnings call transcript Q3 2022

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Operator

Welcome to the Glaukos Corporation Third Quarter 2022 Financial Results Conference Call. Copies of today's press release and quarterly summary document, both issued after the market closed today 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 in the Investor Relations section at www.glaukos.com. call and Chris Corporate the of Vice turn Relations Investor Affairs. will over Lewis, to President I

Chris Lewis

Thank you, and good afternoon.

provided reference before document with with Thurman. guidance document release press Gilliam; strategies Joining and me of a community the call. titled business facts continue the the CFO, document Joe website This Investor has Results investors that designed alongside and section Financials is details CEO, Chairman read the conference and provide and by last This Alex and summarized be been may investment and under Tom Burns; we on Quarterly regularly the the today President the is and be posted the key are associated company has company's to Similar objectives or quarterly a state quarter, easily will to document Glaukos and the designed accessible earnings statements Relations scheduled to Quarterly make. quarter any its forward COO, and company's Summary. to Filings

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results efforts, believe are address occur on anticipate questions than that may activities position forward-looking statements regulatory about in sales condition expected statements about pandemic These environment, of development are press reimbursement on our the difficult operations pipeline materially Please that other strategies to note may you impact competitive to current call are it statements. are results you operations. integration filings which market for release beyond on technologies, our products and factors. operations statements we actual or as current cause uncertainties of events COVID-XX expressed or our products, based the and business get things: subject control. regarding developments information will strategies which include queue. predict from other products the business our of our And as differ many affecting made and facts us, recent of all and and more our and today's are still and may statements. our international Review these prospects future expect events expectations and If have forward-looking back implied efficacy relating the risks, or by SEC market and future to factors, all those additional our future into the of our our financial commercialization US These and or historical statements this among therefore, our to of and objectives, plans, risk and about well for

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Tom Burns

year-over-year our on of and strategic to while Good Chris. afternoon sales with execute approximately reported joining currency advance down third key commitment I'm constant us for all today. you, Today, priorities a quarter Glaukos X.X% basis. our plans net ongoing environment. and Thank a Okay. our navigating macroeconomic you $XX.X pleased thank team's million, challenging

surgeons As range $XXX $XXX million we million commercial $XXX million to are the encouraged guidance net of From and with and headwinds of perspective, previously. our to time, result, our overall same execution on to to the in $XXX expanding versus for ophthalmic face patients. care available US sales our XXXX reimbursement focused the resiliency million we a At a far the to combo-cataract updating be sight-saving the strategies continue franchise innovating remain the of in we thus tools XXXX. to improve

an have with the we medical to including this control comprehensive prior iPRIME, customers delivery fourth uncontrolled novel for for with year, of ophthalmic our iStent several therapy. our best-in-class expand Over patients, for infinite, instrument iAccess, device. product perform commercial glaucoma course IOP novel foundational innovative offering the in the injectable recently US by new allow a and we introduction designed procedures; and system, commenced continued viscoelastic to goniotomy provide to More features activities launch successfully XX/X customers, quarter, initial surgical of X-stent that our technologies, novel

We halt significant launch the to iStent new use market an topical and and infinite medications health glaucoma will alternative a this a marketplace disease. indicated the care its sight-threatening progression MIGS mission for this interventional believe in infancy, seeks to patient create treatment While advance as long to chronic remains as first-ever the device micro-invasive paradigm for of milestone it spearhead to represents that a standalone glaucoma implantable Glaukos treatment. our

securing and and payment iStent half the ordinary on conservatism XXXX. of as process we various navigate first bullish long-term caution of but you prospects, contributions, the MACs near-term through coverage from are We fee about the think we professional infinite's course as

a significant on our delivered deeper to continued access of And grew to continue disease. X% and a again the international currency million. $XX.X of franchise, operational and year-over-year XX% growth grew adoption basis, basis, for we suffering of once constant drive million Corneal XX% keratoconus broader the $XX.X Photrexa franchise from rare exchange patients of quarterly glaucoma our for sales strong of On Health and international overall focus penetration sales in MIGS foreign growing a to headwinds. Our globe. US glaucoma on execute around currency year-over-year, are as reported we sales this within year-over-year as record we face strategies sales Photrexa deliver pleased

While early we it remains, reimbursement initial we've the been address to investments with have sporadic been improvement of following pleased making issues. signs

continue where Speaking development gears of we the pipeline. investments, let's deep advance our to shift front to

profile quarter, prespecified a we primary delighted demonstrated Xb XX% the achieved by trials observed -- Phase the in patients. transformative, results reaffirm end in third positive view powerfully our TR announce the well Phase patients the same efficacy data injection baseline for clinical that mark trend also major which improve study and results The medications. months powerful novel Phase or of can single subjects months. that paradigm top is X slow-release XX XX% pivotal be and treatment controlled favorable TR three-year to results to controlled our remain milestone a TR of company, and a well iDose fewer using the on through fundamentally successfully months, tolerability further for During a supported able safety for of fully glaucoma iDose three These our technology iDose that encouraging points TR that remain XX III line at an both demonstrated were of excellent through iDose

NDA for target regulatory end TR XXXX. continue we and preparing FDA are teams clinical hard at approval work submission iDose of and an by Our to the

The support has the our As for agency meeting an of met conjunction recent our our the for for the the an support confirmatory therapy FDA, to completed NDA of in would epi-on agency the Epioxa, with with cross-linking primary treatment second submission. confirm run the second NDA review study. Phase we submission study next-generation recommended X pre-NDA efficacy did that corneal pre-specified a a endpoint following trial be accepted and keratoconus pivotal which that

XXXX the less data. X that to to for was generated studies FDA's that favorable our request cross-linking well by we the only the enrollment keratoconus. response Despite of shown than our efficacy associated companies' was next Our In enrollment lines slow corneal study, previous other delay epi-off treatment which time end therapy targeted with remains Photrexa or confirmatory we with remain us understanding FDA-approved unproven year. for patient and progression halt for to early believe unexpected to we which completion a of therapies the positioned first-generation Phase by clinical second commence this study second by earlier-stage Epioxa, driven with plan is the

a We of of have outcomes in now robust cadence launches are new patients midst the care to introductions and dropless sight-threatening overtime from years the for that and improve for over meaningfully planning new product Glaukos suffering of transform advance fundamentally the platform product are potential diseases. coming and standard and several the

pressures successfully inflationary these extraordinary near-term from impact and increasingly positioned believe headwinds, longer-term diversified vision. the on feel and foreign monitor an as while deliver mission to to to navigate are other continue we transform objectives exchange uncertainties, we balance well strong advancing While our currency sheet we macroeconomic to continue potential with and our business and we

prospects execute to and the our in to our excited years plans remain We ability about are confident are and in come. our

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

Operator

Company. Our first from David Needham & question Saxon from comes

David Saxon

the questions. seems Yeah. came taking least of beat strength quarter. the to model by took at reimbursement for but like thanks in million only just the million lot my and just mean, $X Hi. a U.S. my the dynamics at up and I despite the glaucoma, it low-end. Maybe guidance afternoon by $X start you from Good the on you guide relative

iPRIME that So that more And are the should XXXX. you're are challenges about preventing iStent you just end. raising cannibalization from from that's other top or think iAccess, guess just as I go any we to trends into new any related I ask there facing are there becoming headwinds we wanted how severe to maybe or

Joe Gilliam

he Okay. And Joe most here. of It's cover wants Thanks that. some color if can. to I'll David. add Tom

took coming What three And would been fair and you this in little through -- with us the probably you're think here I'll currency through and sales really here totally the our is, first quarters into way cost really in year. the thinking then performance when We noted U.S. between million all year really the at sales remainder proud of XXXX, with competition in FX this done. suggests faced CMS guidance. surprise you team probably headwinds is as all franchise glaucoma the and huge of executed face really will to globally. really October we pleased driver impressive quite from the the say doesn't July sitting here it's all very $X of the has back and stable respect our we daily can our and say this U.S. have incredibly about today. that the What a in I our remained which come moment which well as we've look in $XXX fluctuation I year is perspective that's that estimate of ex-FX a when of been when And pretty million year. $X almost in that said million revenues consider nearing we is biggest with

challenges of sequentially. as direction to to. of which supply an hearing given in and really entered that control the is a another big on certainly coverage fourth estimate quite to And the quarter related infinite with to turn COVID a macroeconomic currency. items chain you're foreign $X.X effectively of mix calendar currency year. to that MAC wrong the fourth $X is list less staffing used of the that the with relates stuff of somewhere exception there not immune we're one stability to probably And contribution -- of it is then quarter things step quarter perhaps in in the variants bit we As from million we But neighborhood can't include resurgence I of impact headwind remainder of the the big and it's think, that terms all iPRIME thing which for smaller beyond of in then which closed we ongoing picture things constraints million the currency and the

David Saxon

what profile you nearing we you NDA expect wanted Okay. that pricing And when I maybe I I like. asked it's specifically in. know on to lot of about can then, you're put margin submission a just get don't know on that be could that. given a That's an ask have finer And point then, unknown the the to iDose, helpful.

kind talk of you can would iStent or materially maybe So are that COGS my would for it COGS? the profile what make higher? to relative line, it the Thanks aspects any questions. Is be about in taking there

Tom Burns

submission talks which your Yeah, an first happy David for on preparation address I'd track. NDA be for question iDose and the about part we're to our of really

a year and having about talked that to we've XX That of end us our approval appears for XXXX. our So typically tail next in filing time with in achieve by of next to of NDA be the year. this part PDUFA early puts great file a filing have position months long-standing we the of objective it from early we'll it objective year and of at iDose

the of that around creates with I've company obvious therapy treatment do to competitive this And a I and for I probably by a pricing. lasts glaucoma. sustained into in for been and innovation a a line, So months. But price for Allergan on that truly set won't of really $X,XXX the long-standing of get the product that me reasons has of approximately a investors an arc community long novel respected highly the position great four resistant first the to $X,XXX reasons. in assure case predicate will issues COGS and we're

compute order able marketplace. will over And predicate so any sustained of fairly implant in can price to magnitude that up. margins product to in room And the this you way lot you the of be follow our imagine us difference the a release gives

that say expect just margins. I'll so healthy we And

And healthy of in and well. it's more company innovative as expect going transform treatment We for glaucoma this patients highly forward. a the for position we that move we product importantly, as to a expect

Operator

Ryan Our BTIG. next question comes from with Zimmerman

Unidentified Analyst

guys. you on Thank is for Sam Ryan. Hi, taking for my This question.

finalized behavior reimbursement terms this you I how of for have a usage? canaloplasty to in do expect product physician changes the shape then and to too. follow-up And Given proposed XXXX,

Joe Gilliam

Joe. It's Yes. Sam. Thanks,

the I been a relates obviously over think of it reimbursement. months parts, XX to there's lot as moving last XX to

obviously, probably it XXXX. that margin other Another in one we launching our and product certainly, own about it's relevant categories the around the fulsomely on net-net think helps more that iPRIME when but

and to it think So regardless I and sizable we practices never a accounts all into relates category. the downward something But it's as consideration. fairly reimbursement, this adjustment clearly, welcome in adjustments of case take will that

Unidentified Analyst

your products price Thank you. franchise the growing portfolio with products? in Then this another question forward margins is, will impact how as glaucoma varies I have the among U.S. of

Joe Gilliam

anything product while said a is I what Alex totality shouldn't portfolio that? to alter I general, you think add our we've significantly the to in for profile. don't our know that margin do of want

Alex Thurman

exactly that's As you can Sam, say, right.

portfolio and us historically, at to lead answer range We point. to we've change that target XX% as continue seen this that XX%, nothing our in would

Operator

Our next from with comes Tom Stephan question Stifel.

Tom Stephan

questions. Thanks Great. Hey, everyone. for the I'll start with XXXX.

segments year-over-year consensus maybe we ask Street XX% roughly XX% I'm in your to points guys to of I fundamental think but sales mindful three I sort as year? puts think of takes us should into key with guidance, the going to you and of that each help for not next growth. sort we of head can be

Joe Gilliam

to now we same happy you provide way I'm to we'd for this And noted, quarter of Tom, call. expect as typically as cycle. Joe. on Yes do that do Obviously, guidance our fourth It's the that.

Obviously, reflected. in environment the which mentioned the The strengthen and start that. actually statement the reflect I make that that the be variation, guidance, different of but moves to with in sure and a see XXXX, the not current FX to and what may is for make which continue want dollar folks an for them is as is if is first far even I what Fed maybe as puts models obvious dial and right? earlier impact we're off the most to I'll Street As of prominent, kind advance takes that following immune most the of slightly we

into growing the translated this quarter, of internationally had quarter. FX XX% in significant given As growth that entered operational we're reported growth, they only most that and headwinds as we you actually X% saw recent fourth

but look So as companies that think Again at means all something today, front environment on into that have fresh in we all I to of control we terms sit we that that nothing here the can what are take a facing. heading XXXX.

I are XXXX. in one there for degrees varying is some the there's second think of iDose or revenues The inclusion been

that line which has for approval XXXX. about and just some targeting Tom an in been time unchanged is where time late we're talk You heard the way

expect think models in XXXX XXXX be call meaningful third the to it's that thing – establishing the versus XXXX to year. think cetera, will as certainly And process be need about I MAC that for not et the XXXX. or iStent the contributor talked we've quarter fourth nine come the to we So of a unrealistic half full I guide that from early second the revenues their iDose in pro people would fee thoughtful is they more it and call six contribution to the I'll mention -month the given infinite, in the about a way while understand that in integrate coverage for

around side, more puts combo-cataract franchise, then progress of how hopefully, noise of about from that, that the the the couple from calls. payer and in think perspective. Aside some perspective, last And that stent I the we're commercial around tackling it's the core are about dynamics and on we you talked iAccess – and the that cornea about takes iPRIME blocking stenting continued a think and dampening sort making in of

Tom Stephan

us launch. a Thank then way? from about perspective. sort of sort just of are can you flavor guess updates I form curious initiatives ahead but give operational believe – for I an the time we any sort additional great And in data you. Phase switch of Got any top targeting hoping of I the the I of the full line iDose. if can you of of potential to potential I'm the color. can you up it. That's strategy launch publication approval at until ahead the of data III what guys guys along expect were think And if

Tom Burns

I'd Yes, to address happy be that.

to that in I've come review around as said of set the out really So strong think I before, will launch. serves best or time it peer have company data a the

so be introducing counter our and see important set serve to data. maybe and I the This we to a have well. when to information it's have reserve competitors commercial Phase a able force our data to don't be we'll hit think that where is data we the those detail, our several impact And them publishing time IIb construed biggest I us to launch. our a in I think of III full by again for field I want counter months that strategy around time of will going the Phase again too way. it's give series early not sometime And want see the to the appropriate be it won't some active combination. of

So right It deep. with be launch. It to be compelling be will will will thing it's thorough. be It will it coordinated do. the and our

most really are criteria to important which indices And no this that there I'm opportunities forward clearly be two we the XX% year showing and may to see to well XX% we where about data new are open to think and go a believe and that medications. What Now share. analysis is or the will in if patients upon look the not investors bit this one criteria do and will the on had at benefit conferences little the the opposed device; into product, it right like well of given patients deeper I've value controlled which several medications. over quite there I around XX% as be company we'll for data. the entry more and powerful that right to opportunities, that, controlled I on investors are you responder me of

level. appropriate beyond to we the commercial out MACs marketplace. And able both use It's definitely payers so with to what three data. to in have payment to at exciting with the will we we me extraordinary. were And our coverage data and Phase IIb at and which that assure It's anticipating again this we the is get years, advantage be

Operator

question comes Margaret Blair. Kaczor Our next William with from

Unidentified Analyst

is today. guys. for taking the Hey, question. on Mike This for Thanks Margaret

just ask guys as you now? wanted see of to to core wanted ask, franchise And one on And maybe quick do the what with iStent resiliency just a on some of what the I franchise. right as your and that in can growth far positioning thoughts So franchise the now? market changes, are competitive core with to you return XXXX? right I reimbursement trialing

Joe Gilliam

of stable, I I earlier, I Yeah, really the mean, year, our July continue through recent bit months even so the into course franchise expectations the CMS the characterize, the and that way on certainly is stent Mike. right as the And three four coming the business face fee. or it much US overall has we – a cuts see stability. the exceeded mentioned the pro to Thanks, incredibly Glaucoma of as October, to months in in last over think been

what sets as the that commenting corner think the we're precisely of turn and changing of base year context of enter like. and I'll not a short that XXXX. the XXXX I we this type But into stop did deliver same Certainly, growth face nice whether exit in of up will going we that we last. So as on amount to as environment the

both for execution lot got on iAccess both as the lot but and also the side in as and those I combo-cataract to field think as And us, have iPRIME, ultimately stents, in opportunity segment stand-alone deliver iStent as about got well it results there there's to in in a both increasingly driving we've reimbursement the the XXXX. infinite on of well core combo-cataract think hopefully we've but side of where a you totality.

Unidentified Analyst

presbyopia on the then specifically, on this similar can us And you tell quick XXXX? in versus you market receptivity And on wanted how in compete just to ask to are expecting past? as maybe the the presbyopia in for update, still can guys Phase And what share that side early iLution II it. then just data products others Got market? a

Tom Burns

on all Okay. first Well, let update me give iLution. of an you

pleased concentrations I'm eye, of study. say, two Phase know, both for II we've using as different a we've So you dry presbyopia to in the trials really those enrollment parallel And in in studies. running completed normal and been

as In the of speak. currently we've trial, the data. cleaned in and fact, we've that assessing with eye, dry we're locked data we're we the presbyopia, the in in and case cleaning data of actually And the process completed

we this important ourselves And is we if but looked by the data would so some – is gave clinicaltrials.gov, we have said you the of headroom, done because why available at XXXX. May clinicals by really or

So we've significantly overachieved there.

to So their we And be share you. early your be determine, data have forward, to a very has out question, part show think confidence to specifically. Presbyopia at in and we versus that is viewed, lead how be look give that VUITY the that, would move we'll both ability to and how advantages. how answer have to expect can XXXX the significant a safety And I with we'll clearly will that of with we trial, that of the and to we're continue product data in a and us look the able to our market, us safety position and I from a comes performance we very, it and assess at. we standpoint will efficacy VUITY, that very efficacy monitoring

Operator

Fargo. comes Biegelsen Larry with from question next Wells Our

Unidentified Analyst

Charles This couple Larry. for iDose. more on is on A

standpoint? talk data all. the of seen some but shared endophthalmitis haven't of regulatory and formation, you we then issue bit like a First, any you about Can of the And be the I cataract follow-ups. mean, I've studies, early an could got events if those lack occurrence little it from promising, the obviously in anchoring, a frequent less of the couple a adverse looks of III Phase

Tom Burns

these objective our mean, issue versus of I'm to the at on which been we the IIb rate study, XX%, record periorbital standpoint of the kind superlative the from for order the zero in safety use XX% had had data in III prolific rates followed these headwind exceed introduced, Phase we a this with fat Yeah, leads X% cases patients data, hyperemia of looked on and any measure. more with no the control. and been happy topical with see shown a lids. question, of that XX% appreciate a I had rates variation lower recent been has we do you that rates to to years analogs, that have to When We Charles. between is of products counts. data, I of of hyperemia. and atrophy prostaglandins the We've that, from Phase clinical That's shallow a where treatment three cell we found which endothelial and prostaglandin the

In of identical endothelial fact, of they treatment were counts. in virtually terms two assess how the patterns cell we nearly

the knowledge, to my are seeing of III trial no We Phase within SAEs pivotal the data.

the the topical going who fact are treat you're be standpoint, So efficacy that clinicians to on but to is that order going an assurance entering patients compelling safety that, is progressing despite they're from they to see grant only not therapies. a data from at standpoint should in looking earlier,

Unidentified Analyst

a the Thank on you. just follow-up label. And then iDose quick

label? your in to be setting? for iDose you are late duration of will what off think on and combo-cataract the expectations First, any barriers do that And, terms repeat there economic usage, in adoption is and label or

Tom Burns

Yeah.

question, we intraocular highly that a what or undefined appreciate is have good patients, really XXX(b)(X) course pressure designation glaucoma the label, broad because hypertension. therapy. by is sustained label with opportunity to say seeking. OHT, the This the we're is label ocular for of the profoundly seeking in I reduction or open-angle seek of and favorable with very certainly a a we the under So, label. it's broad We're And and

So, that's important.

this which patients three were medications conducted robust we well on already therapy, the pinpoint sense therapy, using assessed the have to has to able at how not been and to same of long this already demonstrated time seeking length that of IIb study, label or That demonstrated. So, in fewer XX% during we're be of a controlled a or With respect lasts. how iDose long Phase years. clinical

drug drug efficacy So this of with think, III ophthalmologists or sustained performance implant. payment along for justification by for the basis of study ophthalmologists Phase our I iDose and when published pivotal sustained and efficacy data, coverage by be the primary the will

of that So your the first question. answers part

second FDA and that exchange phase think Phase both and part to demonstrate an the IIb able study I do effectiveness using is with negotiating safety we're to we've we looking the in exchange these the to ability at of part patients retreat implants. able -- iDose small to patients do prescient The our to a as were cull and been study

with target of to this iDose full submit be we're process tell say will so part data. that the the the be with can't in is their data implants our our depleted them I the process. have and still that can an medication able of the and I they're NDA once as have So we'll certainty unmasking to to you But And use because submission. annuity of to ongoing wherewithal use exchange we

Operator

question next Inc. Sellers with Stephens George from comes Our

George Sellers

on Thank my you quarter. taking Congrats for question. all the

to hurdles iAccess, terms any the there market? in So, that I and are just in by iStent infinite about progressing instance mind? And such start you're the also iPRIME should reimbursement wanted of keep guess, additional as I launches relation for of those launches devices. and in adoption in seeing How asking are the traction to physician we

Joe Gilliam

your in and the George This role. to call is Thanks, Joe. new welcome

start-off me iAccess. with Let

know has our expect say results be and iPRIME, And consistent that its upon a forward that the will that one the very we that. and course From quarter contribution. contribution the year. in to sort move it's utilization On standpoint market over tools iron as everything be certainly the move the know we or chain it early. more received surgeons that minimal iStent we based contributor that how supply of, with most it's to And to in procedures our dynamics So it. iPRIME as I'd And relates a clearance in earlier up. we XXXX Less iAccess year of get product second of, broader hope going a challenges the little third It contributor ultimately think to continues we in you trying chain the there. dynamics about, some infinite On pretty of as minimal here as you this nice the it that the the fourth and We'll of we contribution we'd been quarter third meaningful quarter supply continue from force macro as still to in utilize forward. sort standpoint that we terms there. recently expect is of clear forward. sales toolkit here. faced launched through relatively in stand I as to, and for out reimbursed we the about this the

a beta launch as here. a part reimbursement that or clearance key initiated have and of really approval We activities plays role

got to sort six to we've turn the is MACs pro As I through the establish of, month process fees. month to get earlier, coverage that nine navigating the mentioned and on

We've half us middle second infinite XXXX. in peer-reviewed got that really of establish At to closely so contribution the And all the in start are point our process to MACs with the we we're expect established working of there. half our iStent forward would that being behind first going from over now. publication got more to the the the and from those of where and able drive XXXX meaningful we've of teams course

George Sellers

And Epi-On That's apologize confirmatory why is and should cadence on incremental Okay. color you about Thank then we a helpful. Thank FDA the for FDA just time And there? with how on if think about you. this, some I I missed should but could costs any we also suggesting the line this updated study? associated And give think for second additional study? you. us the submission second approval how

Tom Burns

this question happy to is Great I'm Tom. Yes. and address.

due And FDA a pivotal drug conduct uncompelling they our call Phase practicing that that trial companies I'll meeting we recent request are who results so the would confirmatory now for very what and Epi-on-like for III communicated procedures efficacy the procedure. Epioxa with the during pre-NDA to a FDA, iLink

extensive production leads Now we important penetration FDA it's our our cross-linking efficacy the oxygen greater yields during is invariably to thus Epi-on across of and to in demonstrated and includes procedure because perfusion pivotal III more that Phase thermal procedure, that the a free results continuous very from of note our study. and the in different the results those cornea that which oxygen radicals cites that procedure

position endpoint that III efficacy our trial. did accepted. So second firm prespecified nevertheless, the the they requiring which completed primary III clinical would But held subsequently to agree Phase FDA the study Phase of be met the

clearly, NDA today. to available and and is studies submission. powerful our on that's cross-linking upcoming And community design product So results only as business the one validating Photrexa safety supporting of continue excellent which approved FDA our procedure the two the we pivotal the build the that's clinical of Epi-off efficacy our just I'll remind

colleague Alex to I'll with ask guess, weigh cost, I to So my in. respect

Alex Thurman

normal operating we to cost George. the and build trial move we forward that will Yes. we those increased The Hi, cost over not going or about that be would out cadence it and periods. second of our stick into normally spend spend as R&D will way through be expense the what is it's to and think absorbed

Tom Burns

go. and early I'll be up trial made open we're study the you about we couple to course basically around in fact in as make an extremely one with ready comment. time this targeting -- the fashion a FDA forward investigators we I've in the for final clinical the move to qualified And months. a Fully approval or of be Since given late probably decision will should moving XXXX. this may able to if think quickly recruit we we'll coming as second that new expedited up then next January

Operator

Matthew question next Our from comes Piper O'Brien Sandler. with

Unidentified Analyst

know, I expectation? that inflationary then And just Do that about and we this high on think here? This OpEx. great congrats your quarter. Thanks good about as of XXXX being OpEx on $XXX you've into for Is we XXXX you moving in still approach million Hi. past we expect in run the How taking moving gross Phil guess forward? a the environment? for how should discussed that question to starters think is here a million XX% maybe company. rate I Matt. And terms is in for $XXX margins the well? as should this

Alex Thurman

is Hi, Phil, question. the Alex. this Thanks for Yes.

on we maybe about payment incorporated to into that out $XX that in last last we you're clear part out operating is talked our It's XXXX. needs anymore. don't that or non-GAAP that to be because $XXX SEC million of we wasn't the number expense on right thing had So the as that so call year the I'll range million it expenses licensing the call point One new this pursuant rules. quarter for

should coming payment you of think So be XXXX kind license the million which about million upfront the $XXX that operating in $XX in in $XXX for million QX. to expense includes range, levels to

about -- gross by you think XXXX. quickly you'd XXXX quarter. profile margin guess into some the sequential I about expense probably some Really as well go as far sort the should asked in As growth operating we growth of

detail, otherwise. XX% is we you in fourth more about that about that conclude not lastly lead margin gross XX% color trend the that, to targeted to in think That it we'll in the in when way will some As continue give to here quarter XXXX on stay but of be us probably able will XXXX way see would play until we more and about that unreasonable an call And talk think exactly to XX% right. detail. we then range around you're of also on sort be and

Unidentified Analyst

on it Thanks the so That’s again. quarter and congrats great. much for me. That’s

Tom Burns

Thanks.

Operator

Allen question Gong comes next Your with JPMorgan. from

Allen Gong

on Hey the team, congrats quarter.

on staffing quick seems when fourth than being quarter. one more just from pretty competitive in that capacity clearly reimbursement have a I what It I are had bit broader think seeing but maybe adjacent expected. about you're trends challenges a dynamics spaces you're and So, durable the weathering just improved around like so heard But we've far well.

that the a how why taking guide? of conservative are your own that business? So, does route you impact a of more to bit Is part

Joe Gilliam

it's Allen Joe. Yes,

US the I through mean month think spot-on on franchise really has quite you're in that remained I and right? stable. the entering of October

the as that. earlier business biggest trying the what of we've is that pleased so mentioned And from -- been translating means international results. that currency, it really we're big that consolidated in our we're to to factoring terms But And foreign dynamics headwinds and the continued right? I with dynamic in back

iPRIME little but into that, some ongoing adequate more we as to Beyond clinical to be a as bit as certainly side dynamic certainly concerning as impacts constraints: on that commercial both Staffing season hope enter or and next us the that, gets as recruit the on skilled we we potential around an challenged hear it something winter the in some So, with continues factors staff behind and that our the right? That not us year we still to beyond launches macro you seem there of immune be well here those. staff. macroeconomic the side there's into entering we and hit around every really to of the getting adequate it And talked we of dynamics some on we're of those more which variants really of XXXX. about in that earlier fourth quarter aren't customers. COVID infinite almost They're certain that and we including -- talk time about fully XXXX. then is the iStent risk things much going maintaining

Allen Gong

a just quick follow-up then it. Got on And iDose.

So, to on? a to in your that But think fully when quickly approval And you late for amount can with have done negotiating needs how got XXXX the of fees revenues approval and J-code? MACs? the can belt? turn with similar about once revenues how message basically that be work an Would year. that probably pro under Thank just do from I in you XXXX limited when comes quickly ramp it the What reimbursement do you. the get to

Tom Burns

is Tom. Allen expectations previously. Yes, said and just And I've set this I so

gate then say will approved some quarterly you When traction we FDA about marketplace approval able of say submit So, once prepared that to can a we In we typically fully very meantime, limited. finally I projected one a rate imagine come I would have assigned approved. and panel but think that be a at have more is we'll get for approval the and J-code want out the the we we'll little expect locked it's will approval loaded strong. FDA we'll J-code HCPCS which very, fair everything to And would quarter and get the miscellaneous -- it's I that lag once and allow we'll what the the be implant. to quarter seek a the we two final for receive charge to J-code happens two in typically to what

of would year. starting the traction significant And so the half I second really starting see traction -- in

Operator

further questions I will at turn have the We this call company. time. over back no to the

Tom Burns

the bye. great is thanks all for staying thank interest Okay. investors We your always Good for to and the questions your continued hope everyone Thanks in And you again today. time Glaukos. attention and for safe.

Operator

third financial you quarter Glaukos' the presentation. today's call. concludes for conference This attending results XXXX Thank

disconnect. may You now

Glaukos (GKOS) 5 Nov 222022 Q3 Earnings call transcript