OCUL - Earnings call transcript Q2 2021 | Ocular Therapeutix, Inc.

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Operator

Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to the Ocular Therapeutix Second Quarter 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. It is now my pleasure to turn the call over to Donald Notman, Chief Financial Officer of Ocular Therapeutix. sir. ahead, go Please

Donald Notman

Goldstein, we Company’s Good our on and our results second be development website provide portion and Officer, call. give Ophthalmology today the the of be who for development update our programs Medical operator. ended on Officer, release joining at and investors.ocutx.com. you corporate accessed Leading release us of of can progress update June and will XX, an on and providing the the the conference close, an Chief after and Chief financial President, afternoon, Investors Antony Company’s call today on will commercial quarter DEXTENZA. This Also a a speaking who Michael an the afternoon, you, product our and will on the press our call update thank everyone, press pipeline. clinical the for President Mattessich, results business issued quarter Thank of on developments XXXX Dr. update will summary our Executive details XXXX. financial be The

turning Michael’s Antony call will remarks, overview before an the back highlights Following for and quarter second over provide financial to questions. summary for the his of I the

Development. For Corporate and be Senior Chris Q&A, our President, joined Commercial; and we will Vice White, Vice President, by Corning, Scott Business our Senior

those XX-Q the Anthony. may in risks Form of this statements turn report results differ afternoon are These well forward-looking recent the call, risks for described on that as as call statements a are reminder, those XXXX. Securities to including will over filed today’s I uncertainties and now our any statements product be of certain of statements. the subject cause Reform activities research purposes development on forecasted, quarterly regarding we to making actual the considered particular, a forward-looking In with SEC. As Act be our our Litigation most will and may variety plans regulatory from Private to

Antony Mattessich

key characteristics to It's problem OTX-CSI do Thank that needs we opportunity that therapies. good clinical post-surgical proud you, inflammation half relative the development we where And Therapeutix' durable have leading fulfills the the We of think key believe pain. unmet that treatment target our physician with solution our of dynamism first end the of the Ocular is space. of that to ophthalmology unmet disease the be finally, Report. product key themselves to more in experience lend to DEXTENZA convenient to spaces, the in It their of that we these care. continue respective can only technology have been to in develop a everyone, patient the therapeutics to become designed we we the as XXXX of the Earnings AMD, mind. could team's build and opportunity most with programs our then satisfy we potential We way whether product and efficient state we will drop-free only the candidates, therapeutic in believe I'm desires transform to efforts more company common them market for eye and could and and believe Ocular, all our product commercialization. but welcome, believe a Not we Donald, begin the patient patient OTX-TIC could in determine a eye first build efforts from wet to OTX-TKI improve the and we current the and ophthalmology are compliance OTX-DED meet apply to size the with unmet the have dry about on of and glaucoma and the the then where to treated. Second solve for become that may that requirements, diseases disease need largest consider that Quarter a standard year, need At able

XX time. proof we've medications. Ocular whereby with the these of designed to characteristics a within sell therapeutics associated of by Account than in benefit benefit prescription U.S. contribution less DEXTENZA have has commercial are Products the able models entire positive that through with selling product to buy-and-bill been a frequency with selling can cover codes. short products achieve be medical period able procedure than principle of of been are account and an at reach FTEs more companies structures targeted traditional team and targeted All approach. a been optimized very employed

that innovative Finally, all substantial that for the patent ophthalmology. need candidates also of candidates of intellectual with novel unmet expected property In the product believe durability. key maintain All believe collaboration new the developing portfolio, highly we protected next dosage adds important least degeneration future. durability that dry an see commercialization as is have an we with will Mosaic a Like future. be novel approach clinically the forward step as to June, of with with the company owned our great in of our therapeutics to exclusivity development chemical developed Ocular. efficient are how that product innovations with It long and by Mosaic, collaboration the well are are exclusivity. have highly wholly area until DEXTENZA that wet discovery and Biosciences protections lend beyond. exciting opportunity announced therapeutics. to marks be to and Working of portfolio of of we XXXX Mosaic AMD, superior expected will discovery our identify into the development incorporate and we periods with age-related we action we entities mechanisms the through macular until XXXX, our established hope way patent candidates we to all In applications differentiated to forms, protection up programs provide have we and at themselves that and keeping are to of add product

As we are a collaboration also Mosaic, with enter to collaboration we new goodbye Regeneron. our saying with long-standing

learned of are how to driver medicines our for suprachoroidal of value central pipeline. a proprietary a Ocular, with to about we never was valuable the hydrogel monoclonal space. for growth formulating of Both about learnings that deal collaboration business, these administration this drivers also key formulate our further the great wholly owned and antibodies While our in will benefit

are We with collaborations pillar for believe company. is longer a to or our ophthalmology own market pursue of the opportunity of opportunity, the agents from this independently on anti-VEGF of which This a With be our developing we leading a termination to central no now retinal will treatment various diseases. have we collaboration, restricted others. strategy through partnership multibillion-dollar become

to net first sequential in nearly Moving to XXXX. increase the quarter, DEXTENZA. quarter, representing the achieved and our same $XX.X an the for XXX% over distributors approximately year we In last increase over quarter a XX% million sales quarter the of

XXXX. in now. us past outpatient the CMS rule-making cataract first end OPPS, DEXTENZA to proposed proposed a this becomes strong it prospective procedure the the approximately of reflects on a For build its the allows volumes. and record quarter over XXXX. by of increase system separate a dialogue XX% or end payment DEXTENZA year payment of this ongoing payment status billable backdrop of on in for final, increase set We against an cycle quarter, market If to second receive DEXTENZA's believe return was XX,XXX normal from user the status, end sales sequential more that into drug In pass-through of it nearly demand inserts growth our with in extension next July, post decision issued resulting CMS to rule their payment the a

issued office XXXX X insertion proposed into with will $XX.XX draft employ a $XX.XX ensure procedural to CPT DEXTENZA facility proposed this Medicare nasolacrimal HOPDs a of patient continue the on in drug-eluting developments beyond believe Category physician's viable of for a unilateral pass-through in in and updated of pathways Schedule to will our whereby was the can We we keep payment the July. to ASCs Physician a XXXXX access the Fee insert code area. The in insertion. any also proposed The the there number in convert rule Rule canaliculus and January the period, CMS that of investors we for code are can and in that

pleased X CPT that Category X since code typically of from We payers. codes the are Category for very conversion coverage the track on and the broader appears all benefit types procedure among payment

associated estimated for is a discrete for million signal case of response However, setting, the annually October that expansion caused With PDUFA use we administration allergic significant office similar representing allergic level the to with of product. seek regard additional potential the work if conjunctivitis seasonal may comment the target AC that in is to line date people both of a the ahead and medical other for expansion It Ocular the in the to with the make XX DEXTENZA XX reimbursement by U.S. approved, await currently allergens, action up is to DEXTENZA. interested and the opportunity and period for indication to more label. DEXTENZA procedures. conjunctivitis, attention for perennial inflammatory transition Most market importantly, potential approval and the providing opportunities party to to

pipeline. our to Moving

pipeline needs number respective state. produce the year. which differentiated four disease highly of a anticipate its for the a source of remains over have the events addresses our we ophthalmology We that each of specialty We key programs, is a of ocular to candidate geared value unmet tremendous believe clinical product key course in and

highlight subject the AMD to continue website. in durability AMD. release our wet with a progress treatment new weeks of patients retinal Vegas. trials other mechanism of presentations of posters of with announced in data for Just recently, of sustained the dosing available ASCRS treatment of administration U.S.-based scope the new months clinical presence few meeting diseases. action to and advancing first and our our we longer potential The in announced five Investors make from we the of the axitinib six or The OTX-TKI pipeline. trial annual the programs be the OTX-TKI company held a at has section wet and eight under the the A interest we and for Company-sponsored and are our our of Las ago, potential investigator-initiated presentations

eye limitations represents Mike, to with products and believe call is drop-off of tolerability that specific turning that large production containing and signs are slow advanced symptoms short-term programs of current is from high of upon the two options. Before continues containing insert we administration. intracanalicular planned. issues drilled encouraged a and disease, our have treatment eye faster be to our address market of in being tear eye onset the Both are disease. progress burning OTX-CSI the increase I we compelling cyclosporine eye dexamethasone by dry underserved patients programs Dry dry intracanalicular and and insert of rates the programs our to want OTX-DED suffering like in have over to dry disease. patient treatment date, To for stinging both to action to highlight than

we our very will and over catalysts to like in-depth over pipeline. would So to two of will year, hand Michael start it our President that, provide Officer, next anticipate With the has a Medical of Chief a the Goldstein, number Ophthalmology call I productive place been to who take at important look quarters. Dr. an and that the

Dr. Michael Goldstein

Thanks, Antony.

back-of-the-eye on Let update program, with an our begin OTX-TKI. me

implant is As fluid evaluating I in Phase implant every subjects subjects previously being the with anti-VEGF with weeks to prospective randomized multicenter U.S.-based have XXX-microgram five treated clinical induction application recently axitinib dosed in data shared in functional to subjects a our XX eight-week to the OTX-TKI at IND we and preliminary in first injection with dose the following subjects two ongoing The I as being axitinib are OTX-TKI Phase administration. some safety, that subjects, assess and by of aflibercept of signals Based is OTX-TKI being implant designed an controlled at see subject as to single as five an OTX-TKI Antony with randomized under anatomical that U.S.-based a we biological date in Australia, and months is compared retinal we conducted aflibercept. OTX-TKI treated activity, sites trial subjects activity early measuring of of in to biological early with durability changes. in to therapy. single trial a anti-VEGF administered eight XX as intervals pleased including of tolerability treated on well have total trial of the containing continue trial decreases exploratory noted, The containing assess

safety in longer observed beyond adverse date. ocular tolerated favorable events observed have across six to one are seeing No subjects. to some or serious have months year durability cohorts has well Additionally, we far a and been encouraging OTX-TKI durability thus profile. reported or of and been has been

emerging, the While fluid. and/or pleased we product OTX-TKI's the intraretinal drug reduce and with is are to still profile interim potential subretinal data

Moving to our OTX-TIC. glaucoma program,

activity, have and ARVO that May showed topical subjects at a a Phase standard I approximately in completed reduction XX biological inocular at clinical millimeters from ocular of tolerability to glaucoma with primary interim in presented in mean durability that is U.S.-based open-angle comparable in safety, We and We evaluating July of of ASCRS baseline care, the OTX-TIC current X data pressure travel process. to or trial hypertension.

Cohorts to six and in Cohorts X months OTX-TIC to action well durability four months in as We has and of served the decreases in and safety response many as onset of in to and have six eye implant profile generally been X. after subjects X days for with for date. administration with in tolerated a X early nine pressure favorable subjects two

are initiation this trial We targeting clinical year. of quarter Phase of the in the fourth II

products making three chronic surface occlusion. burning. irritation, eye, dry disease. chronic of we releasing the surface and dry complaints of patient signs our the to over treatment candidates OTX-CSI product months include We dry and disease conjunctivitis. minimize time, two available low an of stinging eye programs, patients extended to release By the dry are to is ocular punctal disease dry short-term programs, doses approximately the local eye for significant which has with ocular insert, treatment with an disease cyclosporine have progress ocular allergic OTX-CSI which the programs In of eye along duration of and for OTX-CSI of preservative-free the of cyclosporine for for disease, potential intracanalicular four also OTX-DED some surface offers the about namely biggest commercially eye and symptoms for treatment of with

for are with and cyclosporine of of the rapid patients benefits preservative-free We and very action on the therapies available compared eye dry option hands-free with excited potential market. physician the more tolerability administered in helping this about greater currently receive onset but potentially

test, will trial our randomized period include evaluating formulations by followed be U.S.-based Phase vehicle XX different with for production and dry dryness fluorescein Schirmer's the We compared of and the our have signs line update in points we of subjects with score. measured dry in completed other tear different by last as as frequency enrollment disease Consistent VAS, two XXX clinical measured two and a or weeks. of disease severity scale of of XXXX. data masked hydrogel increased II multicenter inserts, measured study visual corneal by OTX-CSI staining expect symptoms as approximately of End quarter, quarter top eye this score analog fourth dry eye the

a Our low-dose preservative-free OTX-DED, product is eye, dry in intracanalicular dexamethasone. of second candidate insert

eye steroid in in of to adverse ocular such pressure treated, by with eye opportunity that can candidate overused with we topical signs a United players While episodic the been likely surface OTX-DED inflammation. can't physician-administered, to potentially smaller product Many size. as and All new may eye dexamethasone available elevated off-label dry dry insert lower same patients misuse patients steroid DEXTENZA, flares. active steroids be their cataract. steroids hands-free of the result experience Chronic have options events as which drug it a have and used toxicity. these patients. drops be commercially are preservatives, of a symptoms, States for offers is and eye this lead related incorporates preservative-free also the believe to long which or Topical dose

anticipated, symptoms randomized eye This multicenter different signs trial, a XXX vehicle-controlled approximately for hydrogel safety of insert disease of end U.S.-based treatment been and of clinical are XXXX. guidance in tightening we of severity data guidance hyperemia, first disease. compared the double of line and two fluorescing our total than and has frequency versus we the VAS to the now staining is of II and in evaluating mass patients designed first subjects dryness, dry points. Phase other by with enrolling currently short-term as scores half expect evaluating top doses with corneal and eye are OTX-DED a dry prior quarter OTX-DED, We vehicle Enrollment bulbar faster initially our trial assess the conjunctival efficacy among the in of eye XXXX

current received at Lastly, for we the PDUFA that patients. of XX, a potentially these an XXXX. submitted of be with Overall, package DEXTENZA have sNDA an allergic compelling for XXXX the abused for standard the occular action hands-free patients, and highlights the the could profile treatment with therapy preservative-free, product believe of can't of need targeting date change we itching conjunctivitis, unmet care target associated a which physician-administered, data end October by

approved, As for like to call now our Antony indication over represent results. quarter sNDA review mentioned, would would this to turn financial our if back first in-office second Donald to the DEXTENZA. I

Donald Notman

U.S.-based revenue revenue and in the million clinical the and pediatric quarter Total Mike. Phase of trials development as the driven as $XX.X the of for DEXTENZA the post-approval field second clinical the initiation Australia reflecting net for in by nearly compared a to Phase net in Company million headcount product from increased XXXX, I also and in with was OTX-CSI costs as represented the the expenses our $X.X the $XX.X II million over Selling OTX-DED, a associated same product revenue costs $X.X were ongoing I with returns, quarter trial. in million trial Thanks, in trial of comparable well product as for and force. XXXX, ongoing Sealant. second Xx included versus same the rebates million $X.X period which total the comparable Gross in clinical and increase quarter increase. were discounts, for XXXX the well OTX-TKI increased second for ReSure reflecting increased quarter million period of personnel XXX% net of $X.X XXXX, Research quarter as trial product net revenue, the $X versus million of primarily the quarter and XXXX. was million the revenue associated as in marketing OTX-TKI expenses Net $XX.X of product DEXTENZA to of expansion refers Phase

the a on of note and with derivative in in $X.X loss same in versus of the fair quarter $XX.X driven per and quarter. $X.X in XXXX. value the $X.X second share of for million same versus the fees. liability increased million million expenses Noncash for The primarily Finally, common and financial respect depreciation $X.X from of loss net a million stemmed primarily the a stock-based $X.X net expenses million reported for quarter Company convertible basic stock increase change or decreased loss was on our personnel $X.XX during price the compensation loss second basis and of net the of decrease our compares general million expenses was and to a basis. The of in a by share share amortization XXXX. on a administrative a diluted loss and the quarter $XX.X million quarter, quarter comparable for in the per were $X.XX associated period the the $X.XX due to per a This With the for professional diluted charges a results or of second XXXX. a in loss basic to

XX.X As outstanding. X, Company August shares the had of XXXX, million

cash DEXTENZA our $XXX.X plans million Company of XXXX. cash and duration This related is the number Based As XX, cash I of cash Company equivalents the business. our and expenses, debt XXXX, that product of subject quarter on guidance associated from the to had on assumptions, including research estimates development XX, versus DEXTENZA million the programs, the Company inflows results, believes expenditure will second XXXX, obligations COVID-XX some like March reimbursement my thoughts. of and capital ReSure of back concludes a and revenues, requirements at cash expenses final clinical XX, planned of $XXX.X to anticipated from and June other outflows turn operating for with pace Antony current This and June and to expenses, as fund among equivalents existing of enable the and to to cash pandemic, and cash the sales service the in and severity XXXX. comments would those financial aspects through and the related call operating

Antony Mattessich

Thanks, Donald.

do before enjoyed a $XX.X nearly call the growing previous up DEXTENZA So quarter. fantastic quick sales, with in million XX% performance the opening over for in let me summary. net quarter the questions,

we clinical standard OTX-CSI with of of our to advance compliance. from allow and II that dry pleased are on continued wet our us patient that our first ASCRS year patient for X OTX-DED. share XXXX of growing in plan and presence the meetings with position first progress key In AMD, in the Phase OTX-DED. progress. conducting medical We in this of quarter in pipeline at the to and for for clinical like We the dosed single quarter fourth our OTX-TIC fourth Phase potentially X the trial XXX-microgram announce set II in onset Phase In to In a We OTX-CSI data OTX-TKI profile quarter XXXX. data insert. a trials two glaucoma, U.S.-based are I into of durable eye a could program support from clinical a our continues product to trial we using rapid clinical care for disease, trial remain that

in allergic in PDUFA December conjunctivitis disease, we date have DEXTENZA and XX, Beyond sNDA action for October submitted XXXX of dry a our XXXX. eye target

enhance we that, XXXX. look call a forward the industry busy our announced which an the one turn step with of products And ophthalmology our Biosciences. collaboration of exciting with Mosaic the be we in that for how most will an We to current forward to and pipelines productive for and company discovery and comprehensive to includes pipeline approach over the strategy, ophthalmic This and Finally, serves marks believe development I a we important questions. today.

Operator

Wolleben comes question line Our JMP Securities. Instructions] from the Jon first with of [Operator

ahead. open. is line Please go Your

Jon Wolleben

progress. appreciate you the the on questions. taking Congrats I

you and do that And outcomes update the shifting? Can on funnel start. one the might And get potential how DEXTENZA Just like? an to the on what is net gross looks proposed that to pricing? when think pricing in for then dynamic you discuss are XQ then we what

Antony Mattessich

Yes. second. last where as I had slower I But I'll an somewhat for in-market was just too mentioned helped that an a wouldn't I it over quarter, in growth hand credit the growth we of is definitely than over Donald and take a There in market. said -- growth, to that much this element somewhat market quarter. for for in rate the stocking we growth us had have a higher than quarter in-market

the So, to XX%. there XX%, about. we two I'll markets We speak let were some growing within in but Don that grew adjustments to were net market gross you

Donald Notman

time, the so improve course the is that an over first actually, accrual are for for is, gross pipeline. two the to of the primary for rebate in net for quarter. question. the the we in the quarter, took did Yes, of the thanks There first that. Jon, us anticipated drivers One

So that was onetime kind begun normalize. it's and hit, of a of a to bit

the the out net of now aspect improved rebates of So returns. that the the the number. that of a And other gross was product to that smaller -- rebate was are --

in data think lower much what anticipated. now market had year DEXTENZA a returns now they're the have for coming a in of the better have We than understanding been will -- have look like originally we've and I over and to the

to finished et but over will So the in cetera, quarters, the will the that of out terms Where we've basically deduction sort be of as a in next less gross range in that levels, this reduce range. in space net. forward. kind mid-XX% rebate go we we'd that depend that discount forward And moving begun probably would to more or several

Antony Mattessich

second you a Jon, Sorry, had question?

Jon Wolleben

growth. Yes. different I long-term us like was walk and hoping process DEXTENZA the through of might reimbursement outcomes those pricing for what you and look proposed could the the

Antony Mattessich

complicated That's a series. very

in You're and about hospitals? the ASCs talking separate continued payment the

Jon Wolleben

Correct.

Antony Mattessich

that status permanent changes Clearly, a are I There's in proposed avenues which continuing in where the rule, surgery. exclusion payment. indicator of mean happen. there's for sorry, that opiate exclusion number the at different for used would non-opiate potential -- you can allow -- through there a the least the separate of product a there's is the

You and happy allows in the important, for has an have the in HOPD rule that, that, are an was continued but see separate to non-opiate in that obviously, -- you product proposed It's have from We're pain. in only you're pain exception a in you and setting. indication also extended the ASC payment. an system that indication the used that not

So There also under that there'll pass-through paid drug would set -- wind eventually out we that access up what a payment non-opiate us settings APC depending be the of on for of would surgical to be give be exclusion. class are complete price in potentials the of the facility the post period.

be taken for allow payment. continued So there's that that a number of separate could would avenues different

Jon Wolleben

dropout data, that on couple blind difference the I the us in you you're looking could rate so forward you're in seeing wondering far a still but comment the formulations on Can in two OTX-CSI, squeeze I'm in could fourth to remind if know I you're data study. looking quarter. the if was And you the I at? And Okay. the to

Dr. Michael Goldstein

is Jon. Thanks, This Mike.

at two OTX-CSI are two there So in being different of formulations vehicle formulations. looked

same the two of CSI formulations, rapidly So vehicle release formulations but amount dissolution one slightly hydrogel the to formulations rates. lead two CSI different one slightly different have a the compositions, is two hydrogel. which very matches the And degrading drug and have similar and to different

part the the of what question we'll was? this. second your And results see of So so anyway,

Antony Mattessich

rate... Dropout

Dr. Michael Goldstein

Yes, exceedingly low.

don't at have but number, whole So it's we low this the exceedingly exact point.

Operator

And with our Piper next question comes Sandler. from of the Joe Catanzaro line

Joe Catanzaro

saw selling a of reverted speak to similar could whether it DEXTENZA to line Maybe progress. here. the Wondering maybe all questioning on you sawtooth July Congrats that the in actually and if back trends you the could pattern month guidance year. of you the historically first quarter? little of rest just seen provide if that you've maybe just more the for expectations bit around of generally, in a And the

Antony Mattessich

of Joe, a you Yes. flat forward. first the quarter. did final continue a had expect the strong quarter as since very a program of We most of acted of sort rebate the quarter the we've had bit -- exactly and did month months the quarter where before to two would going then I of that

for considering decision that going As made mentioned of yet. guidance before, giving we the sales have we to DEXTENZA or that possibility we are not yet do forward, done but the

Joe Catanzaro

Okay. to falls. thinking for then there that similar period? of and XXXXT, during I the proposed the with established that are about And Got fee insertion for I'm silicone where comment reference helpful. any plug it. And the regards procedures schedules you guess That's could schedule basic fee Medicare just press a

Antony Mattessich

Right. I dilation of for there dilation of XXXXT nondrug $XX the insertion around for to and plug mean a a is part just then There's dilation closer $XXX. and is itself, nondrug then which and procedure there's are insertion is the two. of plug

So yes, there's would movement. comparative upward that suggest procedures as certainly those

have do the Although, the of the way similar actually really the relate to doesn't procedures, process logic RUC calculated payments. within really you to it the

I color think can that Mike on more a how little add works.

Dr. Michael Goldstein

you apply but a I then it's other said, most, irrigate procedure system, might procedure, and it's for the was say and are series Antony there's the the going you whole example, analogous simple can, to codes of there. nasolacrimal there codes that that not think, where as and as as probe

a an opportunity to number mentioned, to just levels. So as this number compare at procedures different a of different there's of he

Joe Catanzaro

preclinical squeeze around how program the Regeneron's around Okay. Could maybe just to was us you decision? help what the Got termination speak maybe in a work of your get just maybe Regeneron collaboration. one last of it. the to to sense progressing the If could on contributed view I one

Antony Mattessich

Yes, satisfied the were pace work. we of with the very

work fantastic that in we very scientists how mentioned Regeneron aflibercept at a to with. is this collaboration. fortunate we our to The where actually been to were molecule hydrogel. great -- before, As been a learned we lot have was about Regeneron have the with formulate

We learned get a the also forward. us certainly for the model, could important space that into preclinical be very to and how space, going in suprachoroidal

been opportunity collaboration of occurring look ask that obviously, at in of a more to it, do sort very different we'll in So the to with you now number over. we And outside have the inside that going we're tuned but but to the possibilities excited we see the I of collaboration, marketplace are there's on than collaboration. there given the we truly exactly believe stay opportunities all forward that of have as what was

Operator

question from And Dane Raymond with James. line Leone our next the comes of

go open. is Your Please line ahead.

Unidentified Analyst

on This Dane. for is [indiscernible]

Physician Fee rates DEXTENZA, the the higher, utilization? not Schedule Medicare for this revised how reimbursement are if could On proposed potentially impact

Antony Mattessich

the the that we're $XX highest, So that's the you're talking and we, between within now, the rates averaging about across that have, Yes, the out system getting XXX within procedure about CPT in we T code? are MACs reimbursement the XXX. in lowest MAC code ranging right

among not have in total the We the penetration of volume MACs. difference noticed cataract

better really use there's So more although that, to reason attractive stands doctor. they to payment the need would certainly no in drug of device the suggest that it basis intracanalicular the higher get to order would are, the penetration, to delivery higher be rate that be an to

we're that's penetration what doing, think our really that expect standpoint, higher fairness drives we would get. to that so less level. at what And from the a So should reimbursed drugs we that a about that, be

Operator

And our Company. Cowen line comes Georgi question and Yordanov the from with of next

ahead. is Your go Please line open.

Georgi Yordanov

decision do guess how the And include of Could you program, to on in I the should trial? U.S.-based And related should And plan group guess, study? announce initial the congratulations the interpreting So be from the a us the data from to we TKI control when data? interim of the I initiation remind discuss, and you efficacy we trial. this expect trial? then results to that,

Dr. Michael Goldstein

questions. those for Thanks

population. the is than have -- Australian the slightly So design trial looking that different we we're trial a different at in

So intraretinal fluid. or know, fluid fluid, whether get active who fluid we're asking and you question in rid of it's can Australian have taking that the as we're subretinal patients the trial, you

what seeing different that And in so population. there, U.S. is gone there the And fluid has we're trial, at a or we're actually looking not. the

So we're age-related degeneration treated patients with have an have wet drug. previously looking who anti-VEGF who macular at those been

ask So them they're giving out. is, well, you starting about without we're fluid, anything, you question do. a would And the control and group they give if that them then We're didn't what would TKI. the following

control patients. a a group get remain TKI, have to XX will who is that to -- where it's have the comparison targeting way trial. want three in demonstrate every X:X it's we to on the one patients randomization, And So We're aflibercept. patient designed just the a

we some There take started. that. early probably option chose already has is have do enrollment interim if analysis noted, look that next the to interim As to we an at an not point do planned, although at currently later, year

Georgi Yordanov

plan this Got pivotal? powered to studies? it. two And And then could Would for this in separate potential remind be initiated us, is the trial trial? to on one Or you the QX, Phase we you of two should be expecting glaucoma service program, trial studies? just sufficiently what II would registrational run if need results once the when from pivotal is

Dr. Michael Goldstein

Yes.

three So the groups OTX-TIC, is called know, XXX different those targeting with you glaucoma QX. We're program initiating as subjects. in

for given eye It that it that will guidance is We take, not disease obviously, trial for than powered haven't trials. but long statistical significance. trial takes it how will, dry to longer the enroll on yet example,

II after So presumably, completes. do to trials the two need would we Phase then trials Phase III

Operator

And H.C. our Chen of next question comes from with Yi line the Wainwright.

open. Please go ahead. is line Your

Yi Chen

on contribution DEXTENZA you conjunctivitis the allergic can the indication comment potential First, approved? once revenue from from

Antony Mattessich

we opportunity Clearly, believe haven't guidance given put number. that internal have indication number. public haven't as a we environment, some out indication I us mean, forward but and it expect the we're be move us. to we we the ambitious, no -- We've gives about that into -- we're excited office we for But AC a to forecasts very are very made a is what reasonably be. that we strategic on clearly,

Yi Chen

different regarding OTX-TIC? the hydrogel used two formulations And the OTX-CSI, two that for formulations used same -- it. Got in two is the

Dr. Michael Goldstein

No.

short, in no. So

look that formulations have different indication. every formulations number They PEG we combinations program, the depending of are a indication, we different are at. different and on the every So

programs. no between So yes, there's of really any overlap the

Yi Chen

formulation So from the the is used also formulation different in DEXTENZA?

Dr. Michael Goldstein

That's correct. mean the similar different. based case, actual compositions on are I they're a all so

Yi Chen

Okay.

So in or do expect safety a an both? different with you efficacy impact different formulations, these or

Dr. Michael Goldstein

durability. about Really

terms the well in as on every as both combination the surface of So probably of safety, PEG we in think put I eye.

So we of delivery don't a over of expect period any safety time differences. particular Efficacy is certain for really of indication. about a drug the rate

target we indication that we're at. we independently the the each so we match the looking So durability drug create with desired -- can

Operator

Berenberg. next Dushyanth comes Anita from with Our Instructions] question of line [Operator the

is ahead. go Your Please open. line

Anita Dushyanth

wanted conjunctivitis. get allergic clarity for Just to sNDA some the the on

sort So of kick allergic of I give conjunctivitis? surgery the mean, are of of January, the from also you what for considering that in an reimbursement percentage patients sort can idea like cataract candidates will the that in are

Antony Mattessich

overlap It's environment, and Yes. their moved how treatments to through for like the It's often see have the the -- that get they much office the earlier doctors treat AC. patients for conjunctivitis. that That who into antihistamines allergic step edits not and office extremely cataract candidates are patients high. how or cataract the is in order so something of the in additional need more and

like XX% allergic getting than desire actually there over percentage high something the better who see It much a it for who allergic we so of potentials opportunity. also is allergic world. conjunctivitis is conjunctivitis patients million cataract actually the for to are doctors they're of in in small conjunctivitis all something present that the counter the encompass The a quite what So a are world doesn't of opportunity broader, it. year XX with physicians entities. But

to of be a So get The can the slice slice. a number significant. opportunity even fairly that's large

Operator

conclude participating, call. have session and Ladies gentlemen, you this And you a and question-and-answer for great day. thank as now Thank does conference today's may today's you. well Everyone, as disconnect.

Ocular Therapeutix (OCUL) 10 Aug 212021 Q2 Earnings call transcript