GKOS - Earnings call transcript Q1 2021

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Operator

Welcome to Glaukos Corporation's First Quarter 2021 Financial Results Conference Call. A copy of the company's press release, issued after the market closed today, is available at www.glaukos.com or http://www.glaukos.com. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]. recorded, the archived www.glaukos.com, Investor being available will or is in online Relations call and replay an be http://www.glaukos.com. This section at Lewis, Relations now Director Development. will turn call to I the of Corporate and Chris Investor Strategy and over Senior

Christopher Lewis

afternoon. and good Thank you,

Joining and Tom Joe Glaukos Burns; President Chris and COO, Calcaterra. are me CFO, today CEO, Gilliam;

limit question our remarks, we'll questions, To one and time ample address prepared open everyone's questions. one Following opportunity request we yourself follow-up. you that ensure and the call to to to

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

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

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

Tom Burns

Thank us you, today. thank Good doing everyone well. is and safe joining to for afternoon you staying and hope everyone, We Chris.

and novel and is improving ilink existing the and as At the standard same care, new disrupting for MIGS the company solutions. this penetration near-term we execution our paradigms, of adoption treatment globally patients challenged platforms ways. we year this has We confident more into extraordinary ambitious initial our efficient mission a and and the execute am As reflect on that pandemic-related of pass in we company, remain past that to enriching on of the transformative conventional alternatives I plans. advancing advance drive and time, us goal and well of deeper positioned focused shutdowns our anniversary the for all evolved worldwide. stronger lives have with treatment

the that coming the based our our anticipate on years continue we platforms, invest introductions robust to market significantly over new cadence and where for are planning in fulsome expand We have of product pipeline core to opportunities. potential advance our and a addressable

XX% with vision by sales growth forward reported and as and versus Today, will today potential discuss making million, quarter. results unique a quarter discussion the our confident that financial leader our detail that strong more the update forward net care year-ago Glaukos the year will was and profitability. first are start execution up globally. will our providing long-term to I continued We Health we're tremendous Glaukos and strategic Fueling in in solid but strategic our the begin Joe call, outlook for later on key investments initiatives an of drive on market overall. franchises progress $XX across the the Corneal here conditions commercial Glaucoma

and overall, been with the in our strong the market We first continued pleased specifically, and recovery trends quarter have into through business the April.

ASCs, navigate procedural more based as geography, optimistic to progress leaving stable somewhat were volatile recovery through our been year. for from environment, normal fairly how we remain ongoing this I trends on the improvement remainder closer of and offices, and quarter first market here the us variable continue new While hospitals a by physicians' cautiously have encouraged to

procedural During with commercial the to ophthalmic implantation, to designed which offer quarter, newest in inject, of commercial The feedback advanced first real-world the deliver same designed of W, rollout iStent inject positive, confidence benefits iStent very prospects. stent predictability. safety established for remain inject visualization, we streamline our efficacy and W U.S. optimize technology, MIGS iStent and the added our the results the reaffirms surgeons and

increasing rollout basis XX.X% along although rollout, accounts, improving sales our The and allowed marketplace acceptance have important market pandemic. strong a progress to before this inject technology. on dynamics, than us still and successful IStent practices access the of W, in more fact, evidence iStent of in-person our the with Inject were recovery W limited both In rapid of the quarter first inject commercial overall

to programs past pleased us continue result, The and our a these strength activities aimed beyond to believe customer year the in over have be over year our also training our and have digital first and As virtual COVID-XX efforts I meaningful the quarter. we to helped COVID-XX. by new deepen the past implemented during surgeon for utilized well support continued been we've ways, of various future customers the the throughout relationships prepare

access expand all care responsibility As help a feel for we MIGS, to to patients. corporate pioneer of our it's

prevalence initiative this, Week Glaucoma risk of World a including of testament awareness in to and we honor a raise in a campaign glaucoma. designed March, awareness education to and As surrounding were global new-patient-centric launch delighted the to

care institutions also across offer screens. partnered with glaucoma We United States free to the eye

support the quarter approval several Glaucoma rollout, leave deeper was are recent to Asia-Pacific by franchise States, we Glaucoma health make work growing a Australia, the Australia, region, access these population to to in and stand-alone iStent indication in of including also the of broader Japan the the our franchise well United international and across strong and goal glaucoma drive our sight-saving markets, International the the initiatives of inject during MIGs and recovery we European including Association Outside quarter the Like progress worldwide. key adoption We around penetration in further first growth the in through key the the we successful continued commercial particular. led including pleased in accomplishments, Australia, our W several sustainable in quarter, countries. our performance market were available with first professional drive first and believe along effective, approval as and and globe. inject care the IStent advanced Japan, Glaucoma during with patient long-term to W proud safe, India, the help more World education international care positioned initiatives, impactful during regulatory patient many of We U.S., rollout growth.

countries our optimize international sales while deeper to Going continue market plan train clinical support in quality to grow our landscapes, where working forward, data a have payment coverage leverage reimbursement penetration experienced OUS surgical XX teams, surgeons adoption, our and we to today. drive grow the and direct MIGS compelling to and and presence we

new making have during markets exist. the strong in U.S. future pathways healthy year-over-year have sales exceptional first and where account U.S. opportunities starts. momentum evaluating and direct We also are of In potential initial quarter, and driven performance also continued and growth Photrexa been we investments XX% Health, favorable reimbursement demonstrated Corneal by hybrid in

opportunistically from Corneal of pattern finally, cross-linking of condition, patients to fuel our diagnosis on and ilink the expand optimizing commercial Health advancing execution professionals broadly increased the development U.S. across of keratoconus awareness community, and We new market this streamlining starts, and continue corneal in to training including and commercial to diagnosis systems, health team health implementing economics drive the treatment, to corneal of procedure. our debilitating customer-friendly reimbursement, ophthalmic health important our driving strategies further initiatives, to optometric investing to value the referral initial programs account the solidify

This During [Technical close franchise expect Difficulty] the XX Corneal the systems. we the with integration ERP months to second quarter, officially our activities complete since our successful acquisition of CRM ago. and our roughly the of onto corporate transition Health

next-generation the Phase achievements our without leverage XX/X solutions Each reduce commercial remain programs of pipeline, to pivotal expertise internal gears compliance the the infinite key combined to with While efficacy results or the of for opportunity provide on years our our medication its based full the outer problem this organization's performance on investigational regimens; and focused portfolio meeting and Shifting and the important we our primary of encouraged Ilink to our cornea. III topical halt prospects. unlocking data commercial and and to reaffirms corneal potential, progression the cross-linking confidence is platform a in goal to strong iStent needs. stages demonstrating to including: a of primary that the ahead. removing surpassing technologies clinical XX-month we pharmaceutical we the are infrastructure efficacy X-year early of sustained patient their in development for our Phase Epi-On's therapy these pipeline of compelling iDose and our this meet for non-adherence In provide key IDE positive X-year that announced third, potential several therapy programs, to first safely technology layer second, tackle Epi-On trial for and these of TR milestones glaucoma the further multiple IIb customer critical analysis expectations; clinical showing full ability glaucoma interim achieving significant X data future data of our first, ongoing endpoint quarter the keratoconus endpoint algorithm of of alone, underscores

announce patient we Phase that clinical program. up we randomization are have the clinical enrollment the III and first completed the in For to of pivotal iDose X studies make TR, pleased

Phase iDose are XXXX, progress expected anticipated enrollment We for towards XXXX. this completion to enrollment trial support are for targeting The continue and results our XX-month we the randomization in for approval completement anticipate and in in trial promising III technology submission second and study in TR FDA second NDA the quarter. to this

FDA MicroShunt, announced the the April, Regarding PreserFlo delay Santen in of approval.

associated the direction continue developments discussions with move discussions agency, hopeful to we have and FDA to closely monitor this information we continue on As will front as any with their forward. more ongoing they are and

delighted not pivotal we iStent with could study. the outcome be we For infinite, could be -- of the more

for work continue over FDA coming regulatory a at in preparing XXXX. hard target submission the and to are approval We late months

initial the partner, this which the important us our to necessary completed successfully of with transition commercialization upon For new and have will Epi-On, technology. provide we infrastructure we scale, believe CMO potential

and for We continue submission in XXXX a target Epi-On to the XXXX. approval FDA U.S.-India in

to our iPRIME, new of needs continue designed to late-stage viscodelivery physicians further to We development patients. also minimally advance the complementary a of invasive and system device be support a truly highly

continue undisclosed projects. our Beyond pipeline programs, and dry these including earlier programs, R&D glaucoma, important in also to key advance invest additional eye, retina, stage in we and

with this work in remain platform, on applied preclinical addition well Intratus transdermal noninvasive, this including development advance stages, a eyelid with are of the clinical where initial rights R&D is recently the patient-friendly are trials. we're approach programs. new with that into corneal focused formulations we We One transdermal delivery to opportunities presbyopia several these promising and investigational the we for outer disorders, progress to While using surface platforms eye. programs aim in various to eyelid broader cream-based these we've differentiated, an efforts such drug and platform the announced as as of demonstrating expansion are therapeutic encouraged developmental as program drug associated development glaucoma within patented with completed far. along thus future dry application, go Further, the to our

aggressively are Our pleased patients novel infrastructure, believe a over significantly enable of To a is are disease. world-class Glaukos strong and create we to time. company be execution worldwide. uniquely our we've well In care doing sheet across vision am the drive strengthening benefit I transform our so, and citizens. to assessment that that chronic initiatives to drive systems. strive addressable the by year's create expanding markets our with To leader, our can innovation ability initiatives. corporate key we diseases glaucoma, this, continued unwavering continual inaugural the an world-class A upgrading pillar for positioned health, has transform the to expanding upon of balance fundamentally to corneal expertise, and point, a treatment environmental, social XXXX strategic as global our pharmaceutical of advance pipeline platforms and improvement and mission builds and eye our progress of our global core our highlights positioned to to commitment retinal report on our this sustainability we responsible commitment and recently last released governance built significantly

Over is of meaningful to stakeholders. to to we now a report understanding our we sustainability progress ESG forward program matters, hope and dedication. drives XXXX, our and establishing key present our to enhance best goals the the time how XXXX us what ESG course resources into significant Glaukos, priority examining propel future, reflects Continuing and for policies grow and and that and at better into on invested sustainability us our

health sincere Joe, who and Dr. Ms. more of two and business. experience is than call pharmaceuticals, successful for Johnson's Finally, as Strategy Device led Johnson Leana With years over XX Board medical Medical welcome a in most devices, serving business Wen. joined Chief consumer before Torres highly executive turning Denice who recently a to & of Transformation our recently send significant I'd Directors. like Officer women to exceptional Denice including the accomplished care, management to or and Global transformations, has

wisdom As on policy and University George School health the board. to the led health health and sought-after growing oldest where these physician, to practicing department, and them women of organization, nation's extraordinary continuously at a public issues. emergency and professor and the trusted expert our are operating management Washington of will experience, of of Health, delighted former is wealth health Each range a relevant Commissioner, a leadership, bring Public Health policy that Leana and be perspective, Glaukos Baltimore to she a visiting we of welcome invaluable global

quarter our Joe? with over first discuss the to I'll that, financial XXXX call turn So, Joe results. to

Joe Gilliam

Thanks, Tom.

be basis As to review non-GAAP summarize or $XX website. GAAP a my a encourage pro be reconciliation, section first today's and net I growth performance sales our non-GAAP the reminder, well later in on you GAAP performance forma representing found XX%. of discussing will I press remarks. global Relations year-over-year Investor as which consolidated Glaukos' of were our release of can financial prepared will of our the each in for to million, as our quarter XXXX

in April. quarter rollout but to the a continued pronounced here mid- volatility. few single-digit by COVID our domestically As the to in exceeded a results high by March followed were February a spiking of the cases to restrictions weather due XXXX, in markets internationally, emerged. winter impacted quarter, severe reflect weeks throughout well despite the vaccine respect healthy impact, COVID-related latter as in the we sales first was face headwinds as softness COVID-XX-related that and with U.S., reminder, rebound year the as continue to in start dynamics the and underlying These materially our last the and to the associated ongoing the pandemic With first believe expectations continued recovery, headwinds

quarter in representing in in of India, actions many the while unfortunately, Glaucoma Now including particular, our approximately were Japan net Glaucoma year-over-year we foreign the franchise Internationally, Corneal pandemic, U.S. associated ongoing competitive challenging. in key dynamics, trends. in America approximately In the million, was rebates U.K. turning markets impact environment, reflects a representing Glaucoma onetime throughout European $XX.X underlying offset And first delivered in quite such reflects with tailwinds, combination growing favorable the restrictive XX%. the representing exchange and year-over-year France. demand were of challenges region. quarter France Asia-Pacific landscape by a have seasonality Latin experienced and of led This $XX.X Australia, certain government in $XX.X franchise generally catch-up The and million, the and pricing were provision and our first shutdowns performance XX%, growth situations U.S. to markets growth first quarter sales our pandemic major the and growth quarter a and and which as Health, specifically, remain other markets by pandemic-related sales year-over-year region, believe XX%. associated of performance our which million, with Brazil, stable of the sales

The first the new modest inventory this XX% and growth The partially and sales Corneal driven fourth gross XX.X% was healthy continued of continued XX.X% year-over-year offset $XX.X adjustments worth performance non-GAAP quarter U.S. sale quarter had account remainder been trend strategies Glaucoma margin margin less to the U.S. Photrexa Photrexa in acquisition in a as cause Glaucoma, that was adjustments of the mix. of XX.X% the gears our by XXXX quarter and reflects same deliver, starts, It million related headwinds Shifting in and quarter performance is gross of to accounting. continued the first during Avedro pandemic. XXXX. with despite pandemic geographic at Health integration commercial P&L, and our by in noting in the approximately that the to versus non-GAAP strong associated toward produced the our our efficiently substantial include to of

Our overall levels the quarter first fourth were would non-GAAP million the XXXX. expansionary spending to quarter continue consistent restore as the expenses expect below to that we XXXX, operating first of spending, pre-COVID in remaining a throughout with continue XXXX recovery we as warrants, quarter and $XX.X approximately trend

in Our administrative spending, compared increased million, first the non-GAAP the sequentially quarter offset $XX.X reflecting costs. were SG&A by up X% commercial lower to quarter, approximately expenses fourth

investments loss across X% development million, to compared R&D quarter finished loss first quarter, continue diluted per human programs, non-GAAP share. million earlier-stage fourth operating offset capital core with non-GAAP restore to organization, expenses in $XX.X $X.X the quarter net $X.XX as spending, the we Our lower R&D in were $X.X sequentially the of and approximately down million, the by the and first or non-GAAP a of We clinical costs. quarter pipeline

share was loss of quarter XXXX. million, net GAAP $XX.X the Our $X.XX per diluted first or for

in expansion of also of need, a remainder first would our expect quarter, operational to a $XX.X entered and phase year. significant versus continue and increase to facilities million of in enhancement that of the meet construction expanding California as approximately the trend for invested the development we've the prior in Boston our We periods, capital expenditures Southern and the we

million $XXX of $XXX million, XX, and XXXX, XXXX. As of equivalents, restricted March of had cash investments, cash, to the short-term approximately compared end we cash at

states we is experienced headwinds hope going together which broader integration underlying make related opportunity overall have in iStent COVID, discussed with successful today countries Tom recovery globally dynamics. the exiting markets expect as reflects as final of $XX the penetration still a million, what and for I we Not second expectations mentioned inject patterns, which $XX earlier, business have world how of Corneal unfolding unique to trends few and dynamics and summer forward, state by the things surprisingly, we million sequentially remains Glaucoma. the put a been are believe areas. recently as our across our trends COVID-XX to seasonality headwinds we potentially And Finally, volatility, We all a we our and quarter, U.S. comments approximately most net typical competitive and strategies stable markets ophthalmic XXXX. and quarter and I international And this efforts in XXXX pricing driving sales discussed our in the on said to launch dynamics a that remain increasing our face major in alongside will the the fluid. of encouraged its holiday numerous the increase each Health associated to And earlier. few and of believe variants earlier, around I wave. overall are landscape discussed, that, W Having the context

turn XXXX, As back few pandemic the I'll sequential over we generating Tom things we of as And business improvements the normalize look for now back XXXX continue forward the improve towards expect to to underlying year. here, the assuming would of from to to remarks. remainder a levels, with trends that, our closing second for half each quarter the markets gradually anticipated,

Tom Burns

you, am rapidly proud our while would our by I All to advancing key like right. how priorities actions strategic acknowledging Joe. in the throughout Thank changing COVID-XX a conclude of pandemic, environment. the taken organization I has

and introductions. just in expect execution We are several about new future, where focused we our product X on the excited have to near-term major long-term next years,

strive Beyond leader built fulsome The seek a and Health we pipeline leaves a our upon ability to on franchises foundation we of core me and that, team and portfolio across Disease. Glaucoma, execute Corneal have with platforms. we confident we and as disruptive to vision our as have strategic expand create opportunities, to microsurgical build our care in plan Retinal pharmaceutical sustained-released strong

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

Operator

Instructions]. [Operator

We Weinstein have Brian our first William question from from Blair.

Unidentified Analyst

on Griffin Brian. for This is

magnitude here, the one we deferred tailwinds should first pacing the pandemic, that churning and there? the the the from think through of backlog cataract about of Just on how the surgeries

Joe Gilliam

Sure. Griffin, he it's Joe. and wants if I'll to can. start color, any add Chris off,

throughout for backlog talked of clearly, many a generating world. country for the we've while the or practices So about here generation and a

I we think about actual think that will elongated. and of the think playing backlog look forward more be I out this, as

for these in and them procedures. You operating day have the hours many dynamics where to consideration still a into for of most so providing only be so accounts, to many are surgeons there take actual

think as one market, So perceived that's the months. tailwind should over quarters it they work be through I versus a for overall their many way many but it,

Unidentified Analyst

commercialize Okay. are of more for regulatory more. Maybe your high-profile going And Can and to just in how need you then you're reimbursement that there? some one products the to revisit investments considerations these you pipeline? preparing

Joe Gilliam

a one bit So, investments is our there's going about, historically, the a associated as talked planning We've prioritizing pipeline, I different. commercial about with little on. each lot think, of we think

today. think Epi-On, with and synergistic we that are iDose like the obviously, products As highly those infrastructure we about have commercial

delivery infrastructure, have. we to we those other at support highly as some you with Tom beyond or market continue the investments infrastructure have, broader And as the sort marketing, transdermal whether on we investments we of platform, in access the commercial larger-scale it foresee go pharmaceutical would reimbursement, you like start talked what thinking about there, programs be, And drug so, opportunity are while the that earlier-stage side. point, incremental of to the synergistic an a like as about mentioned, that extent, and that, to certain

Unidentified Analyst

you just think segmenting about of market do separate And Can Epi-Off? quick that what for you timing So more there? reimbursement how maybe Epi-On. about talk Epi-On the you Understood. one need like code between one look a the on and and Epi-On? And anticipate does

Tom Burns

happy address Yes, that. Griffin, I'm to This is Tom.

And so, as disease our could Glaucoma, I in severity. in like do is think according said before, follow we which I position much stage positioning line the to

later-stage we're conceptual the So, more between we that delivers we probably belief when with two procedure. procedures, it keratoconus looking may any invention versus Epi-On that Epi-Off our may at and earlier for more comparisons have Epi-On, the patients. don't We patients, progressive direct but position position Kmax that in a of Epi-Off, for is reduction or more

of different either obligation appropriate I'm feel Epi-On, a to if under are do and I'll physicians seek we think way, see the they'll into just we With want would to we serve the these carry decisions can I investors. reimbursements, best that I for thus, advise choose the Those both regards to making J-code patients. to so. but we I no how once and it think you so procedures decision And consideration, to same for will say we choose separate marketplace create have way,

Operator

next We question Sandler. from from O'Brien Matt have our Piper

Unidentified Analyst

little as on second part to for Matt. late. wanted you're the performance into customers of a rates off ground of then, as the understand This of exit a clarification. on back is the a is your bit you far maybe to if just to start are Maybe seeing up I you're And what willing Drew could kind April, what us capacity, as March percentages business help of open provide. bit of on

that to to markets expect of normalize kind XXXX mentioned you You your levels.

or we about a expect mean million $XXX in business of should of off that so comment interpret you sales business anticipate level that should a Your 'XX, little that Glaucoma that? in was 'XX, I to growth

Chris Calcaterra

Drew, this handle part. I'll is the Chris. first

to can a some and these are surgery get they're being the open centers patients still into how restraint open practice, definitely come in on would terms all reps OR, even In There's in into headwinds of that practices, physicians' is how that to say but of terms ambulatory I able facilities, U.S., still loosening offices and into degrees. the the up. and different many

across the globe, you different see scenarios. you do As look

Here recently things really in because COVID and third Germany, practices of as and second were spike patients shut in offices. France as and reps, wave and and being -- well the down so the into wave restricted, or are cases,

has these issues. Japan. also still to Some there's of in But basis, that all, occurred in on All a it from continues global a better. get headwind COVID-related

Joe Gilliam

your take question. Okay. Then I'll part of second the

very strong improvement I'll well First, in Health, particular, into for reasons so a was just again rates, sequential a mixed upon what the then lull all on as exit lines from what Glaucoma business through there. building Chris that saying, good was Glaucoma is and franchise, April, in for February bit a trend as international more into Chris saw The call I think saying. us, March, the Corneal U.S.

the really in again of I the region, quarter trending, quarter, seen Asia-Pacific first but then fourth in continued. strong the year, we've think both in and last that's

third markets fourth and taken it. really handle you you While on they where Europe, and to has other of and of of in struggle dynamics, muted a how has a the the markets mixed that relatively since some results, that the first quarter COVID, Meanwhile, continued in see we've Latin but or opposite at degree side cetera, been have step this through we related et month moved on it's saw of spectrum, the recovery the Brazil, somewhat through continued forward quarter, that COVID and fourth look April. America, really with back wave as the markets seen continue depending point, as

level relates any talking that, markets the getting it year. the think, in would difficult be we and getting referenced, bit obviously, XXXX, full get for that precise stage. than to about We're back about those As more this XXXX little the results talk a trends to to to comparison to half. And more our I back levels you second relative at normalized

Unidentified Analyst

the super the just iDose? an or remind on with pricing us and Okay. us as the then where I you That's transition And Category stand-alone your Cat codes, then, as will that And give those what for for the your can codes you far and remind sit codes, steps can current today? or those helpful. to update be coding some you process, Xs of business then iStent CPT just are some us expectations those new priced of and where of new process relative of maybe of

Tom Burns

I'll to happy one. Drew, Yes, take that be

step first AMA committee ourselves October came for back remind out let's this that. how major the in year. was couple last developments and of of of business, CPT A and favorable occurred So favorable the

those, stand-alone these for all, then some of a were III we events III of a carrier two little we of how discuss committee we in do those to inject, time, the we And for and codes. creation secure separate at once have place, and are aggressively First able a of that. reimbursement we those of for both that a kind really level bit codes Category code And the creation for seminal can seeking Category later were of code to then iStent will I iDose. and the able that are major pursue

iDose opportunity moderate for the trabecular which future us in will become development, a in patients I think those codes combining with using by major together, of norm vision tremendous to combination our procedure, this bypass two progressive glaucoma. for Second the more prosthetic gives with the

So ability move that and to gives the forward. sanctions us

the transitional into out of cataract The code code movement bypass transition from Category implantation a III of both XXXXT committee third major device. came trabecular a that event combine was the that and to would surgery the meeting that the

scale to conduct And update so, RUC as a status we CPT committee, to surveys fee new said, professional just calculation. Category fee on the value a committee, you AMA physician give the the is relative professional order to assign referred into I in update unit and to code a RVS the side,

a publish recommendation early is proposed on speak, the the to we rule part So make to knowledge, CMS CMS, and RUC going that our will will in as survey, committee a of July. and

Category the working ASCs reimbursement facility the of as are the a among ASCRS, represent convert including we and position Category the Glaucoma with fee side, I, the including Academy will closely, to to fairly the hospitals products these present societies, with that On case negotiate very facility a specialty and Ophthalmology III American from best to others, Society, and for customers. American help we our

issue also, so into this a rule then, proposed a July XXXX the And CMS And final January. November once in early and that be effective happen CMS rule rule, as in there'll October, year, well. place, period, in commentary that of late will recommendation will should probably be proposed goes which

with history us iStent on whole with products. are will So, this know, at, like the to favorable coincide great that Glaukos. infinite, developments determine for coverage MACs, product one do, code well, of you a holstering to pursue through a as pretty fee the code legs we'll reimbursement the each as With Having we iDose, will our we've crosswalk their approval, very the good iStent be typically, in before, a be. what to gives other the have Category what ability And to view as approach determination they'll determination but discretionary until local and we've to, the said professional that be carriers with carriers for for given local the able instance, then the very, I of near product reimbursement for coverage a we'll on stand-alone these basis. something become launch,

have that separate we iDose receive device, the would commercial once J-code again, course, out to alley, to seek we our And So, approval. able a be then, of we power falls once approval. carve within

came we've can the to So, whole, from a CPT we, said materialize X. about are Category excited what very of on as obviously committee. There out always moves that scenarios a code variety of before, III the are when

than Category On III should our because the largely as pro rather fee the likely giving the procedure, it fee designation, average component. ancillary view full it's perioperative professional that RBS levels will the side, current payment versus the mostly system expectation under an them decrease

fee we positive, work associations creating make and side, scenarios this that best the very facility to from sure very, to the to pioneering span closely that a and what in accomplished neutral quite On class with market there's of variety represent we we've negative category.

for we full So represent we to forward are view, and you best of event, forward to that for In and to I investors, move gives look the you and any continue think prosecute. interest the commercial prepared the business.

Operator

We have our next question from from JPMorgan. Marcus Robbie

Unidentified Analyst

on Alan actually is This for Robbie.

another and just on then kind quick quarterly question had follow-up. quick of I one So cadence the

looks a did as OUS what over line said, not And it XQ roughly had headwinds improve, hopefully, levels, your with domestic even bit remains even continues impaired. to kind for and like U.S. you're towards second in quarter, quarter, guiding XQ, in growth you second Looking both to XXXX guidance if the of in you at though, international.

So out is specific driving caution? I conservative, conservatism? to but there -- driving anything normal it that obviously, just what's is that would COVID-XX is that is Or call remain guess there prudent you

Joe Gilliam

Yes. Thanks, Alan. It's Joe.

time both. the some, think reality as pandemic before the well during over internationally. the wave is, in at as beginning obviously, October COVID see least took quarter, the I a fourth frame we here only to it this of of of another went as the trend I bit mean, little we've U.S. of as lines positive at into, kind seen once call setbacks,

a bit So, like, watch sense continue hotspots and still it little make dynamics to think to emerging we the I be the with side. as the some of cautious the variants and on navigate does

the middle markets. with in here some international going And later come expectation I are of think traditional it's long the time bit to of stretch, relative think this could into all to I year season, trying the as think in business, little that second one that of as our holiday disruption both the in, you'll people factor we seasonality part to trends of as that over we're of COVID I is out just summer a and get well cause dynamic the quarter. as of course the our we the take recall, aspects off, some

Unidentified Analyst

just Got year like line But to wait like Or similar the enrolling of you to to soon. the should really it. iDose. to kind a we, second should trial, enrolling It's X-month first hear full expect to data? on top quick finish Phase you II see then pretty just trial that a And that plan nice follow-up finished -- we in when XXXX? trial, see efficacy the

Tom Burns

Yes.

when you investors, have So, Al, show it, it analyzed think to I I'd XX-month And Phase the and our will data. than more that inclined the we exceeded be tell which we important longetivity inclined data the be way, think X-month will to haven't device, this as I initial gauge I to the X-year well, far the for either IIb has show but when that waiting of we've I be would rather because locked we start to data that study, from to really I think show committed expectations.

but So you I my I you the a of commercial give won't inclination, have that so investors will timing, and product. the of tell view iDose full that's performance capability

Operator

Block is Stifel. John Next from

Trevor Brown

out trend that laid a into the Trevor closer. is dig little John. you for to recent commentary wanted on This bit I just

vaccinations quarter, we're in you to the roll procedures pending mentioned some context of So, that electing in defer going the to patients were out. fourth just the

in March, the an be saw you and as us point, demographics, at the April? just could has give quarter, across a would into maybe that this that at you great. all, and how that -- does have update played lot trends that on how people, you in that of some trend out how could And played vaccinated become quantify February, older first especially if the So has that of

Joe Gilliam

in the February. month Trevor, less call, we with it respect about I of we the made to it's the quarter quarter what it more and when comment, Joe. was was that on Yes, fourth think fourth performance seeing were

of markets we So vaccinated the full a patients they bit in vaccination particular, hit the many it's U.S., efforts of go fully procedures. to belief in out -- the decide experienced their et are get steam cetera a until the in our gate to where pause U.K., that clearly, -- where wait and

throughout the things a point, February. you And will recall, the that and in definitely things in to United April. Northeast so, which and led But those nice to here was saw from that both versus thankfully in we again of recovery other separate that as States the the two then It's extreme in in certainly in we've March pronounced hard was some pretty South weather, factor seen winter softness a particular. month, in and that a in month, that

Trevor Brown

be device, you give Could its bundle follow-up just maybe or something the on how then Okay. you intend Is going position any iPRIME. Great. market? on own? another that on sort And would stand you'd that to in to with a you it us comments of

Chris Calcaterra

complementary a -- Chris. you in disclosed that. is Trevor, And hospitals. having ASCs position this pricing in stand-alone good always Anytime product yet potentially products. as our puts We're it our excited bypass in as a contracts terms negotiating of bag. this of a really well options, about we and multitude We with hadn't another have trabecular as see to as you

Operator

Management. Capital Berenberg from Misra Ravi is Next

Unidentified Analyst

regards do for bifurcating you of second of in rest you between line that Ravi with the do COVID Is for playing and team how surgeon the out and Devin half or to in of to the up, that see kind Berenberg 'XX? opening business that global you, here. and wanted in normalization ask training, see I the U.S. kind

Chris Calcaterra

physicians specific in basis. started Yes, W, and a excitement do to this physicians, we is any What around I have that and with would Chris, train around we pleased introduction expect where trained. haven't up. first say numbers quarter. go-forward is open will to the so We're definitely to inject continue the were things on disclosed And iStent we we with and

Joe Gilliam

of versus doctors continue with respect important to our driver the regardless an think train portion the And international question business, worldwide. the your to I of we U.S., it's obviously, on And geography. for

Unidentified Analyst

think quarters to expansion mentioned the a ahead? you few expansion spending expansionary quick -- cadence follow-up year some color one idea you get -- there. look expansionary, for trying ahead, And example, the Is great. at that of Just you a I XXXX. to aspect ahead Okay, into product In regards falls restoring How at pharmaceutical kind and commercialization? to force that. does that trying new sales CR when iDose line get in the where when start Is of far to an that there. look the

Joe Gilliam

Joe. add to Chris, want you can. it's you Yes, if something,

the we're all doing XXXX. up end things other reimbursement respect that's and question than market much in that think in the the something a economics not advance. XXXX. -- spending that to that's we'd access commercial health XXXX iDose, standpoint, and I would With would spend, a imagine you significant way From asked not around infrastructure it's you we on well in not

transition to commercial commercialization As and from uptick both a launch, and as XXXX, to for there, expect you start as standpoint infrastructure. marketing well a as getting begin prepare gradual you into you'd XXXX

Chris Calcaterra

know organization -- we'll to only either part. in be that be is, I'd that -- be a of remember there'll for will that and this thing existing leverage hospital, amount add like in iDose. me, a large The or our will ASC product, I to to a it's component implanted suite good utilizing or pharmaceutical existing sales with an a physician's organization they'll be sales so or be there'll a excuse our but

Operator

Anthony Petrone from Jefferies. is Next

Unidentified Analyst

I'll ask question. were case trial upfront. them reimbursement for for asked. of then the is And first October, follow-up I Ivantis questions some have two still on Briana second Is my to is is This Anthony. a that track on and the questions,

much code payment think changing for levels that I, plus move how on minus do quo be sensitive Category expect new levels? the to physician CMS to you to to the if proposes stock fee would physician so, the range? iStent And or with $XXX Category then, the from you what the $X,XXX are do stock these XX% in from payment status So, III

Joe Gilliam

May is California, and proceedings. Ivantis Ana, I'll Briana, Southern the will where in in criminal to Santa civil trial they're jurisdiction trial. both and that trials Well, be Santa Ana, have regards The that's and is your opening in the they first question, -- in which take up indicated

our the so, And that we the how a preparing. favor. that confident position, fully based at resolved our And would motions been standpoint commence trial our and multitude of it's September. That's in would remain have have expectation this we're trial late of upon in favorably we

at if there's position our changes. that's posted investors this So time. We'll any keep

Joe Gilliam

make part second Joe. Obviously, anything to it's Briana, I code to take to then, question. I'll that stab experience related what movements have physician the at And fee predictions can I on that with of and conversion I here. some But a say wouldn't price business. stock try respect the you as think we about, about Category asked you our clearly, the is,

a but while not that didn't what related it was that seeing we only were back recently think demand. told we underlying in a net I part middle and in expect the had as dynamics to you modest we investors welcome that to to recovery that believe, hold, the pullback the fee, headwind the physician around time, If growth at significant to Noridian region to really fee. of the that, took physician XXXX in impact the some And that

into to fee as year. And about think have they later will physician that's take I something movement so people this here, any the around consideration think

Chris Calcaterra

as for and only asking -- and that trabecular I becoming and this more that Chris is it, this, that add more is it, doing of into are to plays care, more a bypass patients standard I'll are as such, -- so The and thing more more physicians of it think is well.

Operator

next have from Lichtman We Oppenheimer. question from our Steven

Unidentified Analyst

This is David on for Steve.

your on reimbursement to just with off initial you maybe or that launch and necessary launch? slated us of starting of assumptions, investments the infinite the iStent ahead end any towards Just year, could this scale commercial efforts, refresh market

Chris Calcaterra

part this. the take Yes. Chris. This I'll is of first

will will reimbursement, to is be or thereafter. So It out for both and the with to be similar with we by payers that's come -- a commercial working III. designation iStent a Category label expecting will MACs positioned all the We're when shortly be to of how launch that year. fulsome in fee. our January, in the and for likely glaucoma, it have be facility organization. that and We we by Category as get what hoping was we're But for physician did a would III It the will XXXX. code fee advanced approval approved the the for approved end the

see payment organizations. would as over from will get slow that we time start these a continue to more and I So ramp up that grow will as

Joe Gilliam

be XXX,XXX I I a basis. a could hundred million time, as, And year of a add standpoint, the that. a ultimately procedures call call that United a would that market see think as to market it, that the States, procedures it large the that in States, from larger potential the standpoint, let's size in we past expand on upon just evolves. couple of X.X it market gate, than I've over in United depending global from development as And we thousand, hope year how said out a that

Unidentified Analyst

just then Health the more And helpful. That's on business. Corneal Great. one

been posted more expanded another growth driving here, you Is greater accounts and or of curious, utilization about a there? strong function quarter You installed can that guys the what's within base? just maybe existing talk

Chris Calcaterra

of and -- fact is put reimbursement initiatives done a whole accounts. good of to the Yes, that that physicians a It's identifying implementation of campaigns. think things is the of that equipment. acquire that direct-to-consumer lot number. in this we and It that the It's in a is to work and starts. is of easier ODs the plethora lot whole I Chris. payment programs It's fulsome consistent. ensure There's I them whole patients. new There's for customer-friendly say it's would around within things. expansion place both. making training It's keratoconic lot existing driving a It's it we've of

Operator

I back the to time. No further company. questions call over the turn at this

Tom Burns

to hope a and We of today. Glaukos. Goodbye. with for time and all attention so everyone safe, your continued you thank that, I Have day. is for your Okay, you want in thank staying great interest

Operator

for today's participating. conference Thank you concludes call. This

disconnect. now may You

Glaukos (GKOS) 8 May 212021 Q1 Earnings call transcript