GKOS - Earnings call transcript Q4 2024

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Operator

Welcome to Glaukos Corporation's Fourth Quarter and Full Year 2024 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.Â I will now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs.

Christopher Lewis

Thank you, and good afternoon.

Joining me today are Glaukos Chairman and CEO, Tom Burns; President and COO, Joe Gilliam; and CFO, Alex Thurman. the website posted Filings under section Quarterly quarters, its document Quarterly prior titled Relations Investor the Summary. to company a has on Results Similar Financials and a provide details any that key forward strategies we the facts quarter, guidance investment to company's reference the the designed may with statements state is easily accessible or document community This make. and with the summarized associated business and document and the of objectives regularly and the quarterly be will read a by such, This this conference question-and-answer document is for before call.Â As designed to make investors brief transition session. scheduled call, we prepared remarks into ample time ensure one questions, yourself address everyone's to we request question and To opportunity you follow-up. limit and that one to

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

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

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

Thomas Burns

our year cap reported of our acceleration off from a perspective, and ideally ago positioned us development consolidated beyond. results and afternoon, our the year of fourth of $XXX.X the up XX% net and and commercial to a business global and execution, momentum both leaving execute XXXX plans successful sustain in strategic all thank joining million, sales Good quarter. record Glaukos continued Chris. today.Â Today, us Thanks, quarter versus for you These reflect

full million grew the consolidated versus of sales XXXX. record $XXX.X net XXXX, XX% For year

introduced guidance also have full of million. sales million range net We $XXX year to $XXX XXXX

can everything Innovation our chronic year patients standard in full novel the entirely XXXX to the we meaningfully less Our core our marketplaces are drop to business record and of fourth within the performance of reflects do. quarter for mission advancing improve suffering pioneering ophthalmology. dedication that of and from transform new diseases.Â At pioneering vision at we unwavering in outcomes by eye advance sight-threatening care Glaukos, the is platforms

take rare limits pursuit determination game-changing mantra diseases our and commitment and push chances, through paradigms embodies the glaucoma, disease in first, of of will retinal the technologies. science go our Our to legacy and treatment disrupt

in quarter improve driving evolution driven year as full care record surgeons to and Our drive efforts the and for educate therapies results to marketplace physicians reduce continue and develop we franchises, organically earlier international of patients.Â Our by continues standard fourth for glaucoma burden new and globally our broader designed to benefit glaucoma, of the by we intervention to goal build to or both this primarily benefit drug progression IG, and disease slow and were glaucoma with patients. momentum accelerate the pioneer advance treatment leaders and to where thought of stand-alone interventional U.S. the

of growth While accelerating we are the strong evolution. quarter IG driven on interest primarily iDose Within these in early our of with growing of by increasing remain U.S. efforts, stages year-over-year $XX.X franchise, the of we million sales for encouraged clinical contributions paradigm-changing this delivered fourth we record net from XX%, levels TR. glaucoma

the accomplished a transformative as future iDose a expanding of positive and As commercial and suffering be pioneering a Advantage meeting with years.Â Over product professional importantly, to from iDose for market a accounts; know fee, glaucoma that permanent clinical this commercial plans and Medicare alternative an CMS, not growth and reimbursement and launch course coverage sales for TR, ocular for number and for our TR payment we create has very different of as trained our implementing training view the clinical foundation and of and building now of objectives excitement therapeutic brand-new broader of launch a TR, iDose through treatment of drug glaucoma that continue plans and a up it from access our strategy this first-of-its-kind that management support of a for we reaffirms category create to intracameral that was to the surgeons literature, superlative sales outcomes fee J-code, Coming today. reshape expanding that our of key to together the interventional feedback the be an establishing team's X-year energy of we our glaucoma publications include: team consisting with a was X key patients ASP coverage.Â Most hypertension; more national our to optimal one, strong could glaucoma pass set several a surgeons month, XXXX, execution potential new two, three, earlier highlighting objectives support pleased growing environment TR designed and program deliver growing therapy number facility cases MACs our I controlled of iDose continuously procedural published iDose off are we building from trained and and organization anniversary peer-reviewed developing profound. to to X pharmaceutical and with our

commercial more while into focus market Our confidence Advantage and access among are reimbursement more MACs, consistent increased is remains of course the beyond.Â We particularly over overall and through and streamlined payers, Medicare the commercial the here, encouraged on broadening work to support MACs certainly making expand teams are their more there professional our in making do we arena efforts XXXX to primary with are and XXXXT near-term our rates as fee progress with consistent procedures. and coverage professional to including with also CPT schedules in good coverage X payment line the and come. comparable progress now code date in J-code this, stand-alone fee payment Alongside the securing to MACs of generally at majority with X we of glaucoma expectations by

iDose be is reimbursement we in of the accounts advance investments increasing evidence and the robust also past, confidence positive expand by clinical for as body of expand.Â While supported TR. to As several that we expect surgeons commercially, as we gained will recently plan to adoption trained over the further efforts plan iDose accelerate course universe the This continue to of studies. our iDose On noted our announced our we customers front, TR by clinical marketing XXXX.

same clinical IOP-lowering control IOP XX% demonstrating subjects. First, at sustained fewer iDose XX-month TR Phase after analysis as months versus timolol iDose medications a controlled of X the on iDose XX% remain reductions or single of new pivotal trials subjects administration III topical substantial TR a approximately well of follow-up of XX TR's

profile to excellent III addition, XX In TR demonstrate favorable iDose months Phase trials. through both tolerability across safety a and continued

new Phase utilization The failed baseline. we the next-generation clinical therapy. expand form a a profound single-arm achieved and iStent is stent surgical surgery iDose but of designed cataract access take factor and similar Phase IOP study Shifting with X-month has a therapy hold. but program that commenced for combination at to not in iDose follow-up U.S. to business. our our XX.X least, have XX% IV to the ongoing certainly analysis a size in educational mercury patients be to reduction of for Xb/X market TR, infinite iDose months original to implanted twice improving or landscape clinical demonstrated Second, And and last compared TREX continues iDose capacity. TREX, of iDose drug nearly very mean glaucoma our clinical TR medical millimeters X as efforts of

MACs that original During with fourth the LCDs X consistent iStent the is of that quarter, final X implemented coverage reconsideration our infinite request. for established updated MIGS

for devices In MIGS also utilize the addition, these cases final same coverage that procedure. eliminated LCDs different in X

to we may the believe fourth continue XXXX market did this these LCDs providers during cause associated continue some into turbulence LCDs. these the navigate impacts with anticipated, we transient as As in and the quarter, expect

reported year-over-year basis. Moving year-over-year each again to remain health tailwind we product in reported the anticipated our prior sunset market world. constant once our drive on, the of in XX% to scale our agreement currency XX% stages record standard initiatives early This and international the market to our access IG and as of $XX.X the sales international strong portfolio new on continue of plans product on million expanding our as will forward French of to quarters Consistent was glaucoma fourth growth globally on in MIGS new approvals XXXX. care rebate execute basis and delivered of and We also our with revenues. authority region growth infrastructure expanding net in a XXXX, years a broad-based major was ahead and quarter franchise in favorable come. in growth This

currency $XX.X this trialing our net health corneal the may of exchange emerged Photrexa XXXX. foreign of discussed, products international delivered we become alongside And end competitive previously million. into in headwinds the new at net some and continued the of of of $XX.X major that franchise including finally, headwind have sales expect As million, material an increasing year XXXX our markets sales

quarter realized or MDRP. Program As revenues company our the growing as impact into reflect as XXXX, entry Drug result of a fourth Rebate results a discussed our of Medicaid throughout Photrexa the

shorten up and health shifting to FDA-approved their on the we from improve our the pleased provide December first suffering forward forward, to corneal require are that expanding eye. this outermost will Epioxa, corneal disease. one NDA pipeline. suffering patients therapy Epioxa, for working designed meaningful a is step continue In rare for the removal to to an potentially the time keratoconus we advancement the as of sets to the announce approval believe keratoconus, the end corneal us the and corneal patients next-generation the does treatment patients able The it NDA the front iLink Going patient with not our to sight-threatening that FDA drug recovery in paradigm for submission Staying by review to cross-linking keratoconus of This process of in disease. represents look closely times treatment epithelium, from XXXX, of submission FDA of cross-linking the focus keratoconus. for and decision our therapy reduce Epioxa pending brings community to and access on which comfort in with an anticipated procedure We of being for milestone ophthalmic a closer company continue XXXX. important noninvasive layer represents submission

next already access Epioxa and with across targeted investors the are underway worth planning commercial the We of commercial well for It's that year. organizations and our cross-functional launch of leaders reminding in supported optimize market launch a to a to for patient also team preparation pillars by an disease us with with historically times frustrating long-term challenge access, pharmaceutical and provides Epioxa rare at us opportunity the approval persistent Photrexa. right the the

a patient's We each pattern to biomechanical Phase to clinical a to for tailored use deliver our treatment also iLink topography. therapy corneal to X program advance designed modeling unique continue customized cross-linking third-generation

broader our company Beyond promising prudently cross-linking markets our transform continue franchise, pipeline in advance have our we that our to time. the to invest we believe ability successfully significantly platform novel of expand and over and technologies fundamentally addressable

trial X milestones trial iLution a for discussed, pipeline a U.S. commencing for our anticipate in to addition In we already Blepharitis, Phase PRESERFLOÂ MicroShunt along IDE XXXX. with

future. we in of spending investments of and strike continue the right prioritize position such balance planned development operations the our plans to an our our discussed, augment now our area to we the and we as capital cadence future recently our to in infrastructure facility and investment to manufacturing One we've strive plans. As where announced current build expansion risk-based expansive in is of Alabama support and function, Huntsville, research,

executed convertible significant course designed further derisking of senior XXXX, we the sheet successfully position. principal our a the several leading $XXX.X Including interest future of our already of XXXX, amount reduction in the transactions balance Over solidify strong million as deleveraging cash retirement as to due notes to our of a and capital expense. full well in

transactions with unwound of quarter, of $XX approximately convertible we fourth million this our for proceeds call associated cash generating capped the addition, our In successfully company. during issuance, note XX%

XXXX a result, debt. million our an organization a conclusion, our X,XXX whom like as believe cash who than are of position I'd never been company employees roughly capital every that the of just recognize ended no how and tagline. never in we it to a mantra and something promising. we defines and our globe with lead and stronger strong Go we for is equivalents Rather, more company I around has As In $XXX First" "We'll as day. foundation more prospects our is than

transform XXXX vision our excited of we and the growing build our for worldwide. to patients are business the advance benefit to mission momentum We as beyond upon in in

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

Operator

first Tom Stephen your line comes [Operator Stifel. with And from Instructions] question the of

Thomas Stephan

Tom saw or bit Obviously, of and lot with Joe, you you, focus elaborate investor can with in the ramp. to start maybe trends the a you observations just on quarter on iDose then a the year-to-date.

there have terms anything that's from I So factors different to new wondering late if of in just guess was of plan? out I'm anything call maybe emerged that and

Joseph Gilliam

in start. to the the be characterize I'll what quarter, that through Joe. really saw fronts, TR the the it's strong he Tom, of really to on to third. anything, all Tom believe at I can Sure. of performance, revenues heads execution add -- would down wants most a iDose what And end. I in another and relative your in probably doubling led quarter if we the of would models quarter

of prepared for the we there, continue more mentioned long-term about importantly, evidence I think think to as body be in takes of our it the outcomes further Tom underneath supported to that, kind with success of pleased peer-reviewed remarks. foundation growing build blocks first his the and clinically, and the building that what real-world that's we by progress and really foremost,

It's in Novitas professional slowly with added think And alongside as on procedural said and begin continue establishing recently consistent the confidence. processing as on what of fee we'll expand and XXXX, We that and front. dynamics in with then over we and methodically established forward to These trained progress parallel, of we've of into as continue as on mentioned, and to Advantage see and now in And staff we've and move quarters, saying the front, say iDose. emerged us we with That's then to the reimbursement the certainly rapidly And J-code the an on we and surgeons make of couple efficient Tom but enter progress to education as before, Medicare half for about the make number kind iDose continue and that in the Noridian subjective, as a on all is we year. the office really the X a MACs of beginning second continue commercial reimbursement we like QX X are a here iDose. the milestone here, now finally, but normalized associated are adjudicating been important having of I've formal policies course associated to that Coast the roll I of out manner. of First support I schedules track. can pharmaceutical remain

we think it's in going sit a into sure in as have bit. that I'm macro as growing our to here a is impact years here including today, the the from going have we'll to iDose on confidence have the impact standpoint, reflected XXXX on I in So ahead, guidance, get we

Of course, remind having procedural continue said to that, as I'll pharmaceutical, complex. ecosystem folks the a adoption that pretty is

ago. Just as we it years many launched was iStent when

that. what fourth we're the fee are and beyond. XXXX did a the a can needle, what about and from for pro established quarter we reimbursement exactly sometimes progress as a So take it schedules setup in but just confidence few and to excited quarters They means move

Thomas Stephan

iStent great And That's between a on on Could business revenue U.S. my that the Joe of to elaborate But components the different bit just segments? a color. you core color guide be the guidance And LCDs would color the XQ. the guidance, follow-up of just XXXX helpful. components due any just any seems on Alex. Maybe be growth as slowed then the or would bit well on in like great. it

Joseph Gilliam

Tom. it Yes, did,

think iDose stent the mid-single Obviously, digits or new your of LCD performance first offset for And question, I quarter latter of to if so in part part of that certainly, as looking down to more break than think, kind let restrictions more the fourth was the slow see in to Specific I quarter. I you and we the kind we growth, think your that importantly, the forward. did referenced our me down the understand, non-iDose will, the how of guidance the by then question.

to save I'll And more forward the we think around specific for so and color that guidance on. folks other questions point, as ask the on

you the expect royalty do as headwinds flat the even those revenues expiration the LCD about expect to non-iDose of all told well that to XXXX. in generate and we low think to we single-digit for as As volatility growth down our maybe guidance, we that Hydrus

you all you'll expectations of we about it that a really around we'll our that the this put bit throughout we've iDose. more think very and XXXX guidance implied in made as way And when and kind franchise healthy into with together, see call, so accomplish what year our the we'll talk again, and growing is iDose

Operator

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

Unknown Analyst

the bit XXXX quarter. to This Congrats on Larry. follow-up the Simran for just on Maybe on guidance. is a

like the half weighted see return to So sounds how of continue Is throughout in that half? we the from in year? U.S. Or it see think business headwinds depressed terms LCDs. And XXXX? about impact? Is to some -- the growth second you do of glaucoma, the those cadence the iDose core volumes and some to should of sort that think we first throughout how do do expect of about cadence

Joseph Gilliam

Simran, it's Joe.

into So maybe for headwinds. a the and I'll question about the start in talk seasonality second, around then get reverse I'll LCD just

leads that. So for are the part little And your year in quarter. as driven the sort third fourth and of XX% the -- into that was second would you the sort story Clearly, really are that's second of equal it the investors question. first iDose the typical quarter of the the it, closer of ramp in going in that's towards And half. largely a an to, the around quarter, of the your again, iDose weight seasonality XX% I the XX% into of just know, part call within contribution by while, the something part for maybe and point around continued fourth. dynamics the the increasing heavy in expectations first quarter, underweight patterns having XX% probably XX%, in second middle a been us then to in for and pretty weighting drive to first

the the headwinds of a quarter, I half. half where get think their as would and the bit get to peak expect second XXXX. the in as you we the that of bit of certainly year fourth you already little certainly, related experienced in in would into that fourth start a slowing be headwind at quarter little here And LCD we first the abate

equal So think throughout year. don't the I that's just it's something

of I the expect as to the for in over expiration even business. that. for iDose potentially as our MAC question, think improvement of But which of the glaucoma driving really should Hydrus some U.S. growth in those we down second I see quarter, headwinds combination the flat the the begins said we well do single-digit year, prior the low royalty, as non- overall part

Unknown Analyst

we I should Got very bigger like it If helpful. iDose it. looks picture MIGS XXXX, procedures be how And just thinking about at maybe a That's total look question sales. in population eyes. U.S.? implantable XXX,XXX the XXX,XXX were surpass only iDose in the about eventually the patient about is XXX,XXX Could of procedures the there number and number procedures MIGS of to procedures on

Joseph Gilliam

I overall, probably more after a overall, frankly, supplement call that's as numbers bit, term, you know, like done. glaucoma long XXX,XXX which that in interventional a cataract you over the said define the to today, iDose it, eye with what just When about it, is referenced I put and And includes as you out infinite Simran, think market. we just or the being done destructive I'll especially XXX,XXX larger iStent to market. are That's you think going maybe we there. maybe are combination medium year that, tissue to absolutely, procedures more the XXX,XXX a or market, MIGS some to with that much, where you of the talk quite procedures XXX,XXX procedures largely much glaucoma

XX are are million million million the at hypertension million somewhere in neighborhood there XX or to time treated. when U.S. either of north actively any ocular of that, XX XX we of are think given that So about given diagnosed in time and any those at have eyes the around glaucoma

in iStent market XX surgery and larger a after with XXX,XXX going to market XXX,XXX eye combination other constrained infant million labels we've as products with are as handful historically. the broader much a that that in well much with iDose versus of been cataract all So

Operator

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

Unknown Analyst

on for Ryan. Izzy is This

with just stick iDose. I to So wanted

if have are far course as the guys limited seen was bringing growth you've the XXXX new in of you the gains share users? market has of of from rolled out curious I more expansion any and and Or launch, the been DURYSTA? you seeing over So so

Joseph Gilliam

Izzy, market overall would more characterize growth. I Joe. it it's as

I the of we're of in the as think a phases movement such much was just interventional -- earliest we're much, larger prior Simran, question extension an by that towards stand-alone care. asked market

think lot many for obviously, future to of for and the there's be in I a products, lockstep. opportunity DURYSTA including foreseeable iDose growing

as I about So it an It's share. opportunity. less see

think do I on the the shortcomings eye and front real clinical we drops to are question -- from take is, as continue that how an with industry, that from legacy share are perspective. a

Unknown Analyst

helpful. any of That's the status updates And you do readministration? on have

Thomas Burns

Izzy. do. to I'll one, we be is Yes, take that happy This Tom.

so with I months. be investors, the been Indeed, to We've FDA take promised several has. process to for And some this it a going will time. that negotiation in is as

now the statutory half think post-approval a submit appeal for to a And we're XXX supplement I in of year. has during this the the a good first to days that. to guideline of submit position we FDA be FDA once able

see a implantation commercial available trial period and planning product TREX product. design having during a potentially And should the approach the next I de that entry, we're and of know facto iDose for so already remind we have as belt investors, our getting successful current clinical claim a of for whether in not the end iDose. year, iDose though, that we this or of by suspenders the I readministration that being

way, So we're either covered. I think

on strongly in I we're But to anything. the said have continue be hopeful. not We as past, counting

Operator

Your with Newitter comes next the of from question line Truist Securities. Richard

Richard Newitter

number you're the that and training looks especially your progress I how trained? And physicians anything of Maybe of base reimbursement quarter and launch. I want a last performing effort? kind we on to us you're the you here, being -- you some can said doctor any get installed terms And iDose into on quarter like? start a for, docs commercial MAC what to how iDose you progress on sense have that should exiting give made, of moving going know about of the to think being in just of full the color

Joseph Gilliam

Yes, for Thanks sure, the question. Richard.

training granular there's really numbers. primary iDose I is tell a gating and We reason gotten What the that. that continued reality as can is a extension have and for sufficient is who in as to angle-based it an existing there of the not thousand, are item specific that Training that for training. progress of iDose know, doctors more -- The product. that is not you of several around surgery, surgeons have already relates you than

little a item. we pearls of at has in sure dynamics like to armed course, that, a Of across that's rapid really general a do a that procedural It's to different. expect of But solidified. that item would date. education they're with not fee make professional to make to outcome with rate. I on reimbursement kind date sure of been training nuances I the with associated earlier, office referenced be the successful had we're continues really a and staff little in procedure. pretty the as the country lot iDose. gating But around success on delivering doctors that reimbursement not gating continue pharmaceutical turned a We've and a of are the training in confidence XXXX, schedules particular, also We the as

And through themselves. and some scaling item, training ways, gating so And we if want the launching the of doctors to upfront sure that afterward. than bigger cases surgical those make a the early will, you is probably of there iDose that towards we're in

Richard Newitter

of kind similar a then And helpful. question. That's

range expect a that are the what quite where but about constrained newer in you all at and of are small pulled others? utilization rates users, recently even and from we can regions utilization maybe kind more baseline versus users month. go in talk to high of talking doctors granted in curious, some iDose implanters about even more just teens sample, I'm you're So currently that are seeing the timid they users, a per as reimbursement rates

Joseph Gilliam

they of of said absolutely, out. they comes improve. Yes, a In I the be still both the much to you're clinically those hunting question wide of is as a and mechanisms spigot And terrific. the in most is and after optimization will, and And need, doctor important going element patient the fast a as is we changed by is procedures an to And then But where most for when have can an factors. that early what account? sure and underneath markedly that obvious they've couple account you more that, handful how turn the farming monthly and very you I'm when are ultimately with if the that turn outcomes really a payment launch, confidence the continuing alongside handful play driving that, you job just of you except on know doctor this process, wait continue both it's doctors, by talking of days account on just might going. the our this range. earlier, of XX-year how we're online, basis. see on or cases, to And you're of doctor I at said.Â And see numbers start certainly and a there. you not got confidence have so from that to about do if to will, than the We that just a scale of a the And the doing stage reimbursement kind of now

Operator

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

K. Gong

the touching guess just business. the on I rest of

the in next you're have of what we growth tailwind I other of the And XXXX? understand year, catalysts another for outlook with strong the how to any France closed year? year really quarter kind from bit dynamics in that but a the or mind from think out geographies new losing course over You about might a keep of international. you should

Joseph Gilliam

some another that ways internationally quarter, growth good strong XX% surprisingly have We question, in we the highlighting did a Allen. quarter, XX% grew north its from of strong a our that's teams of delivered entirety. quarter broad-based Yes, which year in

Now as the couple a you things, takes. and so you puts referenced I'll of give

relative is combination XXXX, a I what as closer things. The to just think business. move describing single-digit implied something to in for slowdown we I really forward our that that in of from comes high was growth guidance of

it's but for that's to the at a as First, headwinds, XXXX. surprise material the setup of not a year-over-year pretty on FX calendar, basis probably at look point here, we this anyone earnings

and competitive referenced if we'll on their of in transient last Second on Alcon French is quarterly amended expect and referenced, in these business the And trying also impact, impact not call, certainly agreement. feet the we that France. some the and as, of is underneath potential rebate there. our gets in the We not see tailwind from them new. product That's our launches last trialing particular, Japan a markets what you that lapping

single-digit when international the expectation all us that that that waiting together, those high And so put glaucoma are things for we're of on sort you business.Â There things lands on.

in that been into we've product for Europe, not is opaque around for can't talking in little we've the world but currently baked until it. now to example, the we a the really a For given, But We receive nature the iStent many our reimbursement in of Infinite implication of getting the while. works has particular, that forecast. approval with that a MDR for growth an and again, markets that process It's us, way process driver big the to associated Europe. broader regulatory

biggest probably that provided. I being the that could say, one, just would drive guidance upside the single to So an we

Operator

Your the Jefferies. next Michael comes of with line question Sarcone from

Michael Sarcone

I you change there. give update start, was and the on what you to Just a of TRIO, could commercial reminder whether on us iDose an you're timeline? expecting give hoping or Any stand us

Thomas Burns

to, Yes, I'd is Tom. be Mike. happy This

that is right And iDose be believe it applicator. will of so existing now, iDose size talked as we take really modification we the millimeters. for about, a about our the us is incision X.X implantation to an TRIO, going typically, And

hope with iDose millimeter. a get At chamber. significantly you closed X down millimeter, in X neighborhood And of somewhere that the to have TRIO so is our

coming risk division we You into been dehiscence for the a proportionately, this of required The have think aqueous for has and to in the done. drug you're out very safety small process. the during favor of of plan the FDA maintain humor any to in-office study our a which clinicians, reduced be of be has reasons, those a moving chamber planning in part will pressure.Â So for eye period able the that this

available our the product need be a of process we'll so for follow study a to MAC the appropriate so able and which TRIO align by the time.Â And is period have modified to as seek MAC with safety capability these our those give so going to this expectation with MACs And or is reimbursement in small the patients be in quite FDA. iDose to surgeons of to the in approach for nicely beginning midyear establish we code doing XXXX, We'll payments with of to predictability office.

lines marketplace. the up, product year-end So we'll have like in we how We we certainly like this see. and by what it XXXX, think commercial we

Michael Sarcone

Great. for a That's guess me. just I helpful. And follow-up

guidance, about Or the how continuation XXXX anything see penetrating from starting can about you of iDose about the have think on expectations into benefit just the thinking expectations context side? guess, growth to of, traction you're primarily population? do is commercial for Medicare I baked a you this in you some As talk any

Joseph Gilliam

of reimbursement in lion's both certainty are if X well fee all, I it, if share, the MAC expectations really professional imagine as what of this Mike, expect can by progress as out the really the progress, terms that I'll you foundation will, as year the Yes, you come in MACs the there. schedules forms, think make call to not point continued and the of it. at driven the we we those to the J-code around continue That final being

in. in Medicare going be I expect are to come make launch of expect that. we can as As us, and way from we you the some tell year, our But to Advantage that the part very the of you do methodical will we very, in volumes latter commercial

outside that expansion prior process the traditional fee-for-service. of and along sure that the can You things to authorizations of master with these make customers that an various Medicare come want

to then not to we're through sure chase volume customers way We're year. that there. are as we're and our there going the ready continue So make make we expand to going to going

Operator

question next Mason of from with line comes Stephens. Carrico the Your

Mason Carrico

J-code combo in MAC doc in about combo for where a follow-up there, like are initial Has Phase prophy change at noticeable the and there looks about been reception second just utilization what for a just to jurisdictions? you in And Could along. all setting releasing the cataract that? trial? farthest in cataract dynamics talk IV that the you data then Could payment utilization those following talk as guys you the

Joseph Gilliam

Joe. Yes. Mason, it's

combination and notice. cataract certainly benefit data that in procedure iDose utilization the as would of it. there procedure expect cataract added you of sort get what given that and now stand-alone around strength taken put of iDose obviously, of is goes terrific think, we've the out It's when the we a I in with line

certainty I established those of think in where second your zones board. with bit is fees a the the across little what professional to it, question, experience part more you you growth around see and now MAC J-code call have, seasoned

You of doing starting of in within et combo bit and largely you're the doing the see you'd see number expansion stand-alone. the procedure which a it a But more to cetera, doctors, mix, accounts, expect. little the as cataract, percentage

to it they've So with well got combine natural and it's combination the with for. only patients with utilize data, they would qualifies this this that outcomes those and their start as the as procedure cataract for that sea legs confidence surgery think you in in it they

but our you are utilization is we the for it. well. behind that seeing much that would obviously, glaucoma falling driving cataract and it of surprise on that But being, So as some doesn't procedures, interventional opportunity larger tell is reason stand-alone I me

Operator

question Petrone next from comes Your Anthony Mizuho. the with line of

Anthony Petrone

the MAC MACs, catch follow-up. when When X to And quick up in MACs a And that think do in they'll Noridian? the terms happen billing of issued just fees on just dynamic The pro did quarter in this you have those sticking the quarter. here. Maybe A? I'll that then cadence

Joseph Gilliam

the piece Yes. retroactive equation, Anthony, a that important were, to very think, X. I'd in professional January one schedules first, were of announced fee They say, I one. mid-January. And that's

then adjudicated properly. be it's you their systems and got in all know, As to

compensated that Sometimes see goes of and recurring then consistent of kind have time see start little to it we But rollout those before to back take nature can the payments. impact that. And There's to of just of the bit they're a you realistically, that, of what being properly for started the saying time process There's the account confidence education process things a goes there. an don't I that along the building the happen for overnight. these was that see procedure. their and earlier, doctors that

to something fee of and it's more of the year. in think, out last process getting that was quarters, that in seen are confidence then we're So surgeons fourth the surgeons. end of in over that many making that schedule of, going your quarter into update increasing I you And professional that confidence will, put it. out accounts alongside sure rolls of and Meridian, and utilization still in point, the expanding where We've that aware the if many earlier third driving clinically and the quarter

So today. past, and it's executing well in a journey quite we're one front on done that think, that the we've times on, and many I

Anthony Petrone

And corneal, just call and follow-up U.S. U.S. modeling. MIGS a quick for it headwinds.

in referenced Joe, it, question. a You prior

And have would some I just U.S. there, little but direction if corneal were headwinds, a to maybe don't then think on messaging little that the flat. essentially touch help. in the too. Maybe maybe I know here MIGS you seeing is presentation bit. a just to down, just U.S. message comments there the

Joseph Gilliam

it the side. each the just for I'll all franchises Maybe -- Yes. of guidance back bring I'll together again on

through earlier go again. the that me seasonality, reference I You so won't heard

On we or the saw of the XXXX some growth that what the about of navigating we corneal certainly low through MDRP the we exciting of Epioxa. MDRP And expect growth in ahead year-over-year year think first with this in the can will from this year, make kind certainly I health our ultimately, believe deliver impact launch all side, This peak sunsetting half. in of and the probably continued even year will lapping way somewhere headwind the we QX, as be an year. then headwinds the XXXX of is single-digit franchise entirety in for

single-digit So low growth XXXX for cornea. in

through the to glaucoma expectations international growth about expectations iDose on well models, and side, in U.S. going year. high update And we're of and and are to second to we towards and what weighted volatility low I given combination put non-iDose progress something You the imply royalty of on $XXX watch we single-digit there that we down expect heard as Obviously, I it's But growth, are together, your half the flat all million continue of north that for year. you way the continued expect in for the which, the generate to all potentially then and the LCD particular, as to closely headwinds talk digits. -- was the would the the throughout our QX expiration said the more we certainly when revenues initial our to me you XXXX. think of that's expect, going make year, you single make Hydrus growth in

Operator

comes Steven the line Oppenheimer. next with of Lichtman from question Your

Unknown Analyst

on ask terms you This is to guys just about Steve for uptake a different little I of are bit and facilities systems. what iDose wanted today. in Ryan in seeing in

make that smaller inventory, of difference working can wanting cost do high seeing affordable and they with adopt device? larger sure carrying carry people for any the the on it And are any to the make to you facilities between Given to them? plans you that have it

Joseph Gilliam

Yes.

pharmaceutical is with I terms. as iDose longer-dated cost as lot I think, like cost the of mitigate So of case off, first launches mean, the the relative that with a often carrying we it, and

You've accounts receivable in common very industry again, with standards. pharmaceutical our probably balance, seen that

successful in call And so doing we cash of way, that and component actual, for pretty the it. I'll that been it, facilities, we've mitigate

lot you systems I between to are nimbleness where you exists it the and going bureaucracy get things customers delta to the get versus physician customer, like the will, if and think that do ASC to more sign-offs, a committees with have your there's go even hospital average through will. ready a and themselves of you when want larger that clinically and if administration always

to certainly in XXXX. expect our ASC more making certainly will, if the we that the certainly indexed, side we're the continue of make but progress much of you so think we've with things, side So progress far, towards business hospital will I been

Operator

Danielle comes next question your And line the with from of UBS. Antalffy

Danielle Antalffy

have question. kind just of high-level I a

call XXXX Sorry, XXX,XXX I'm like When the first were on back in XXXX. years of it sold at over, to of it, second. looked a we initiation, on and we X to launching, first looked years an iStent but the you stick going guys in launching, working iDose XXXX, iStent back for few in

about happen a launch quickly I my years obviously, XX you to as at volume like guess numbers. to ago, different quite iStent? but get don't is, was launched when it wouldn't XX.X a because I need pretty it question appreciate the So you high that ASP, what's versus iDose big

better between just and could understand be X that launches help gating you me So great. the the the if difference would factors are, what

Joseph Gilliam

element the X, launch new was a Tom there you're the And in -- The think and when mean we similar But that pioneering are was. start. comparison about right? part each, pluses candidly, I is launch a I Sure. most than of more that you're and And I'll of much in doing here category, first minuses procedural-based of period. certainly the it a environment.

physician are you're lot the changing and on doctors behavior. combination surgery, was who driving practice pharmaceutical glaucoma clinical true of trained training, surgery. a you're certainly the have a now true and with delivering of stand-alone means earlier back That and it's cataract in with iDose as but with obviously context excellence and some iStent the And in that so not general then interventional we point of matter. Today, to more angle-based questions, the procedural just

know to we're launching years continue really same that's take than training and the the obviously years many iStent. to of were care after but it all hurdle develop it. shift lower going Those today, we So of market, within positives. is to standard in are much the going XX that the a to element larger these much was physicians, when we time ago middle At

is reimbursement, the add is years front it more when today with side, XX patient also much is back pharmaceutical consideration dynamic flip XX economics. is would Medicare a than that the center was always premium-priced And it or ago. then procedural real On a and more I you're which our as Advantage today dealing in

traditional a fee-for-service. less to And than that covered so covered have lives navigate in way we comprehensive are Medicare

it hard direct of there. to there's put correlation. think that's and obviously, overall lot impact, And And you I the when so a a opportunity that's an But it's apples oranges to all candidly, draw there. together,

whether patients make to in just various issues and probably that Medicare, situations more glaucoma the why the interventional ultimately they're Medicare first kinds commercial fee-for-service around ideal more it, fruit would of individual like surgeon think drops. or and what things present combination prescribing can the that the think suffering for then on within patients just focus from I are and stand-alone things or and versus a move the better drive you Advantage cataract forgetfulness candidates, that really it's the mobility opportunity the in all lower-hanging

Operator

our to closing back would concludes like management it now that session. for question-and-answer to And I remarks. over turn

Christopher Lewis

Thanks all Okay. and and your thank I well again. want today, to as for time thank and your you you attention Glaukos. Goodbye. continued interest support of for

Operator

gentlemen, today's you joining. Thank all and concludes Ladies call. for that

You may disconnect. now

Glaukos (GKOS) 20 Feb 252024 Q4 Earnings call transcript