Ocular Therapeutix (OCUL) 12 Mar 212020 Q4 Earnings call transcript

Good afternoon, ladies and gentlemen. Thank you for standing by. And welcome to the Ocular Therapeutix Fourth Quarter and Year End 2020 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. pleasure Financial the Officer my Donald over now Chief Notman, of is to call turn to It Ocular Therapeutix. sir. ahead, go Please

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

provide the of for the an I financial highlights and the questions. for summary a Following remarks, back over Michael's fourth will turning before Anthony quarter overview call to

Corning, For Q&A, Scott President, Chief Senior our we and will also Officer; Vice be joined our by Patricia Operating Kitchen, Commercial.

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

with everyone and was Thank Therapeutix's great notable report. for to and DEXTENZA, due as pandemic, pipeline quarter developed uptake to Ocular Ocular the counts, product as several challenges commercial it a in largest well progress quarter On candidates advancing of market year of capping the ophthalmology. you, welcome tremendous Ocular, made target fourth a our of the global Donald, despite opportunities earnings to yearend all being

DEXTENZA, past our of employees, Thank and year, For our all clinical like in XX% than dedicated Been we patients I for to with and rise this and individuals then extend this quarter growth XXXX, million the sales our $X.X involved quarter year-over-year increase our XXX% million the trials of comparison. previous hundreds which but past fourth investigators, more over our thank all. investors. to net success would clinical you represents the to seem quarter more

expect we contributor forward increasingly DEXTENZA company's to significant Going be position. to net cash the an

particular we of cases. January in HOPDs a to no hard recent year. of aware closures and and in key number these place this and determine took data The February volumes slowdowns of While in are U.S., spike we the in have in bulk of actions COVID ASCs cataract to response the

of Clearly, in representing to in-market we despite two the two first to factors. ASCs were units pandemic volume scheduled addition is procedures headwind of over increase of key what prior first the tailwind flow expect than of in the to year. into delayed two procedures. final to the impressive get Fortunately share are quarters cataract volumes from a the the increasing months cataract of and growth normal of fourth backlog of a quarter sales, XXX% sales Contributing DEXTENZA continues DEXTENZA Billable increase greater drive neared for the three distributors growth. DEXTENZA's months a that year, market XXXX of and year, become brisk. In over the XX% to nearly was the HOPDs the the

importantly, drop both and -- The to that of product relieves most differentiate following is ophthalmology DEXTENZA as ophthalmic and communities. the physician the benefits specialty is in performing the the and daily continues products burden differentiated simply we'd of The appreciation product hoped. pain inflammation to highly First and awareness patient treatment surgery. steroid grow the in

work becoming the easier and XXXXT. with and We've HOPDs. also tremendous Secondly, the code and DEXTENZA product particular, of ASCs working both now able we had representing you have MACs administrators success standardizing I'm been the for to associated country. seven all issues coverage now reimbursement of And XXXXT. for In to procedure XXX% payment partnering let to is through DEXTENZA know in that in use related we've with MACs the please

needed to two status net the realize approved, announced use included adjusted nasolacrimal and inventories to monthly HOPDs. canaliculus. product and performance, all inserting the we launch We eye figure of the of and in-market in billable extraordinary administration distributors for of the we so that drug-eluting provide to of report for become no programs. but replace in-market ASCs to across of I potential units into second on where period, service. here a XXXXT effective the dry this during and a monthly route this scheduled November to of which sales to X of facilitate continue inserts Longer-term, XXXX. code existing new receipt the longer drug-eluting sales payment our ensure insert programs same in billable we intracanalicular to better This sites investors, and give other DEXTENZA, may in nasolacrimal an note while January detail units an level is sense It immediate to code use canaliculus Additionally, the availability. which Category expected delivery. our distributors benefits also year, the to of expect our coding we for but placement for the plan and of Category route CPT If should X quarter also beginning DEXTENZA, for in any the a develop delivers procedure our is reporting to permanent code quarterly

Now sales to to our return specialty has volume specialty current to specialty of other. standard but To to reporting distributors to Ocular confusion only each from the parallel distributors. protect and reached we sales distributors its end its closely data, net from level, industry sales on our and sensitive sales that to the plan avoid our competitive customer

reporting the X OTX-TKI data and hypertension. At advancing macular and Beyond and degeneration treatment for pressure DEXTENZA, of to for primary interim pipeline. our the wet intraocular we angle ocular other Glaucoma the of patients promising the of we Phase both OTX-TIC XXX make open glaucoma reduction progress year, in excellent start diseases with presented for continue or age-related retinal Angiogenesis

I eye a for treatment OTX-CSI dry the disease Phase the patient we Phase in dose of eye September. X results subsequently front, in in On September. We trial in first announced dry the

estimated design their Each December of global patient dosing X OTX-DED, sales. of key at aggregate that specialty company eye symptoms successfully we the of at for product of February. key enabling states, of file just strong differentiated of that the candidates and have the of short-term signs end announced annual in a programs the is represent Phase markets at treatment Financially, in billion ophthalmology and needs first unmet over are For segments four in dry address IND clinical in end financial disease respective that highly $XX position. our the the address We disease.

we oversubscribed an completed fourth we entered public XXXX. More payment recently, have We December, of in offering million raised upfront in that quarter approximately the into AffaMed related $XX the million received $XX initial net with to proceeds. in the collaboration

on payments, tier receive million future $XX $XX upfront the in we the well million have aggregate digit to as milestones sales. in double as and also Beyond future payments, potential royalties

sheet. All of strengthens our this balance

mark we we Michael year. candidates, our along our With look importantly, on progress sheet could to and DEXTENZA cash these ophthalmology, an and service, planned debt all through through sufficient clinical our to to revenues hand productive another fund we Officer, four Most an of to Sealant on and and president Dr. net Chief update ReSure product capital we're now to I trials, Goldstein. forecasted over fronts, is us. our XXXX. key fund forward equivalents, thrilled cash it operations, and and for on we point to projected from with of believe balance sales our provide of Our which Clearly, sufficient programs are Medical expenditures inflection are clinical each X will believe Phase where with our cash

Thanks, Anthony.

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

measuring the the assess trial by well assess preliminary clinical and biological to those from safety escalation in OTX-TKI, XXXX subjects Australia of that subjects a month, dose from tolerability X we continue designed the virtual exudation label as multicenter and study anatomical is at degeneration cohorts. to We Last open all angiogenesis functional presented being data meeting, conducted activity highlighting and three changes. to as in interim Phase in data

with The micrograms, OTX-TKI or in XXX Cohort first micrograms enroll. three cohorts, enrolled, therapy micrograms XXX been have of X, XXX combination micrograms, Xb, anti-VEGF and Cohort Cohort XXX used X, Cohort Xa, to continued induction now fully

X seeing in fluid early We and months, following early as decreases some including of signs two as are Cohort biological in in subjects activity, retinal assertions Xa.

to months steroids ocular observed encouraging and longer or been favorable intraocular been all a seeing half subjects needing XX one and pressure, in serious inflammation adverse months with six to Additionally, up and a reported to well profile, subjects subject no no treat ocular OTX-TKI we Cohort are date. in those durability with elevated have tolerated in or durability of safety generally has X. cohorts, events,

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

middle an terms we in next using the microgram therapy. a and XXX have United to now in States, OTX-TKI single plan a in controlled steps, with starting trial initiate exploratory year In clinical IND we of implant anti-VEGF along induction the the of place randomized

in been January, the X glaucoma United clinical This biological data all reduction baseline prospective current tolerability study to of to millimeters two In the of our Phase standard that eye. as Forum. with IOP OTX-TIC. intraocular non-study subjects from clinical multicenter early the open OTX-TIC. results and open suggest action X response Onset days label XX Glaucoma well a pressure glaucoma, safety, activity New many placed to insertion. evaluate as of in mean enrolling decrease States, in is with XXX safety months comparable at seven OTX-TIC after subjects generally eye to hypertension, pressure one In cohorts have profile topical from XX of a and months trial angle consistent data travoprost implant. subjects term interim care, is generally we top been durability tolerated the or pressure of for durability over Horizons presented in out line the Phase showed Moving nine single today. or favorable six enrolled in the for eye to a is ocular has has four program the to fully trial Interim primary observed from controlled

implant three Cohorts to five have has observed bioresorb We Cohorts and months seven to X. X. to in been months it the in not and seen in X five X and move in And

study have meaningful cell pachymetry Phase in time. endothelial X counts fully or no seen enrolled. now But We corneal clinically corneal changes the over

X to middle XXXX. of to in plan Phase clinical attention the we turns initiate our trial, which expect Our

eye dry of include OTX-CSI, of are significant for the period product designed along modalities to dry the three chronic releasing for the believe tear production signs Local in the doses over of designed the of surface release potential cyclosporine an patients. we programs, dry which to is burning. punctal chronic is products the which which same and programs with treatment increase patient are to symptoms allergic eye an for minimize have to the the is dry duration biggest free preservative And dry disease low also making disease. treat conjunctivitis. by ocular insert, four time two OTX-CSI eye months approximately target of has which short with eye we cyclosporine We of of dry programs, our available progress in to complaints two combines patients candidates OTX-CSI the disease. surface, term and namely some staying commercially over about occlusion disease, extended treatment In OTX-DED, to intracanalicular for ocular eye, disease time, what treatment

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

clinical staining, we by XXX with last well pleased analog disease test, signs completion eye fourth of Phase been masked disease previous is we vehicle which that schedule. planned of guidance in in a as X ahead announced study the corneal severity different progressing multicenter ahead first of Endpoints evaluating top this to for approximately frequency X based visual formulations data of of We quarter, scale, of trial of weeks. Following hydrogel were randomized study as initially insert as measured Dosing two we of points initiated a and symptoms half this line in production followed expect by clinical XXXX. the the Schirmer the the of U.S. now compared quarter successful Phase XXXX tier and eye study, OTX-CSI subjects include will report has period of be score. dry measured and fluorescein dry dryness enrollment measured eye by a score, XX going the

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

randomized eye physician adverse and evaluating formulations in hands-free vehicle drug Phase been experience trial, which first off have free, episodic Topical lower subjects hydrogel scale based of administered, vehicle signs controlled designed our insert X double for related of approximately compared in staining. dose incorporates potentially visual treatment term clinical a announced eye dexamethasone We cataracts. This and preservatives dry disease lead used the safety is efficacy and two the and inflammation. U.S. by with is such and a of dry long are their dosed to for dry symptoms trial masked bulbar therapy. a conjunctival misuse short same analog a dry we patients disease. all flares. commercially patients which pressure these toxicity. steroids offers as While This treated ocular size. have new of result elevated or can likely in insert flares as with DEXTENZA. In surface topical steroids opportunity using dryness a fluorescein assess preservative total of steroid patients high Many signs evaluating candidate eye label to have frequency OTX-DED, hyperemia, to and score product steroids the a multicenter recently the smaller and for OTX-DED OTX-DED may to Chronic symptoms XXX with of we believe also eye be available active different that eye of events corneal

in the We data top XXXX. expect first half line of

would treatment an sNDA highlights over fourth care for of we the of the preservative call that current XXXX supplemental If package October product these have that NDA PDUFA with Overall, turn DEXTENZA. DEXTENZA for change at Lastly, to This review NDA action for XXXX. approved, ocular to itching end date the patients. associated in-office indication believe administered -- like need received of to and for profile and data the of a submitted supplementary I can we a allergic the the compelling targeting XX, therapy conjunctivitis, now hands-free target our financial represent back would Donald standard results. quarter our free, yearend potentially for physician first unmet

XXXX. in the trial to for million Selling Mike. fourth $X.X for in And commencement force quarter $X.X increase associated and increase. reflects costs, revenue OTX-CSI, quarter, the Phase and the executed expenses quarter of reduce the the of of DEXTENZA for of from clinical as in and revenue trial, the were discounts above. over decrease The million XXXX fourth XX% Overall consulting to million unallocated Overall costs, Net were expenses in and trial. by in fourth the an allocated of quarter fees clinical and DEXTENZA to modest as compared the full million marketing Phase the million And XXXX. Net fourth reflects the product revenue product OTX-TP increases allergic strong travel net in offset quarter from year Phase in for driven quarter and XXXX, for primarily $XX.X over the $X.X -- of $XX.X OTX-PKI. versus $XX.X for in by of reflecting with revenue DEXTENZA $X.X the for XXXX. the roughly X Phase cost reduced X XXXX as $X.X offset million trial full product competence relates XXXX. sales the quarter December same as conjunctivitis spending for million period Research mentioned during quarter the largely the by on trial for product personnel expenses the decrease by in costs half and year XX, the in consulting reduced to clinical was from Overall net expenses versus the with clinical OTX-CSI. by was $X.X associated $XX.X trials increased XXXX related increased of the approximately costs in costs. the fourth XXXX increased a decreased $XX.X a and XXXX, decrease XX% development company expenses. R&D OTX-TIC driven versus a $XX well ended Total quarter XXXX, offset $X.X the and costs, $XX.X million marketing personnel revenue Sealant. million approximate increase for X reflect million related to net three and million reduction million primarily $XX.X rebates million sequential trends X was million of selling also the in third product Thanks, includes refers primarily revenue reflecting of $X.X the of total comparable the XXX% fourth third and XXXX, which ReSure Gross returns, uptake for sequential the product second year of months and million expenses net in

million consultant fourth This comparable net of and for on fees. administrative share increased basic reflecting personnel increased and per G&A period quarter $X.XX million fourth expenses the Overall fees. expenses stem $X.X general the to $XX.X Again, $X.X same quarter $X.X in With the consulting for the year a compares of of and expenses a primarily million were in loss primarily loss full and XXXX. from of increased versus a Finally, to or $X.XX in basis the on quarter, XXXX. from diluted for $XX.X increase the a a costs personnel million net respective The million financial for basic share a per XXXX. reported $XX company $XX.X basis. million, or loss results loss diluted of and million in

million of fair expenses by million increase in and $X.XX during driven a charge share associated or The a $X.X in for in value net million fair notes. non cash basic a basis to The million basic XXXX. a exclusively XXXX. price $XX.X of and the company's fourth and increase the $XXX.X loss same company on XXXX reported related the of net $XX.X quarter diluted was modestly in compared diluted the the the net based the for were loss quarter a stock depreciation to of charges operating primarily for per year per full due As the ended also quarter December or convertible significant loss down or includes of a was and loss share almost XX, a versus loss on the quarter-over-quarter, million basis the common $X.XX in stock compensation loss change Overall, $X.X fourth Company's This to XXXX. derivative XXX% value of in change liability of with non-cash

company As had March of the XXXX, million outstanding. shares XX.X X,

million offerings. cash announced in during cash proceeds million net XXXX, cash year XX, fourth equity from $X.X million licensing benefited million million in quarter quarter proceeds $XX.X XXXX. we the full October One secondary in the million. had $XX at balance of proceeds. of payments from December ended $XX.X of restricted equivalents December The $XX.X cash versus amounts end $XXX.X from of AffaMed. also cash These for As two of and upfront from million $XXX.X agreement exclude Fourth in cash for in and proceeds net in with recently benefited the one net the

the million, XXXX, in proceeds offering or year in the associated full has fourth net like pace This from Anthony will benefited common other XX, on and financing course, aspects ended to May to XXXX in $XXX sales equivalents of net expenses, DEXTENZA of and and December For total December cash cash financial proceeds balance proceeds back XXXX. my the those million obligations, sales stock cash revenues capital requirements business. million and a secondary a agreement to thoughts. from debt for including I turn the activities $XX.X and through And the to net ATM from and $XX.X of under with from executed research December our expenses, of DEXTENZA anticipated current would early related expenditure results. estimates related our our expenses earlier is were $X.XX and and of believe that $XX.XX planned cash of cash subject inflows yearend on including the XXXX severity call as and from enable ReSure respectively. summary comments existing of at development the equity outflows share operating sales plans in clinical quarter duration the cash This and of to year. XX, guidance products pandemic, we service company assumptions, $X.XX, of programs The fund of prices and the COVID-XX operating October and and offerings Based from of concludes commercialization number May, a and

Thanks, Donald.

to wet in AMD, states Phase the markets, programs and $XX sales, DEXTENZA performance believe through to support for in So fully continues a plan the resources billion OTX-TKI ophthalmology let X up sales. to their pipeline In summary. clinical for within four have account stage call raises we do Phase a over me of of fund our successful the the large quick trial and our momentum With questions, estimated disease licensing opening capital new and agreement we completion of before standard global aggregate X the in set assets durability. to prospective XXXX. In patient could clinical could U.S. the that profile trial standard to dry a a while X plan of continues middle disease, plan of for new that product in one into initiated a trials, potentially randomized set care to care a potentially product for middle two support XXXX. We advance OTX-TIC for by trial a initiate We glaucoma, for for based Phase the clinical In OTX-DED. that Phase of eye and compliance. program we OTX-CSI, one a X annual

now For the quarter OTX-CSI, we expect year. data top this fourth of in line

OTX-DED, half data the XXXX. expect For in we top line first of

October Beyond questions. that, we XXXX. with eye PDUFA and for disease, I'll turn call dry look sNDA productive December for and XXXX have action of in And submitted busy forward a conjunctivitis to We a XXXX. the our target date DEXTENZA allergic over XX,

[Operator you. Instructions] Leone from Dane Our question with Thank first comes RJF.

Your line is open.

XXXX Hi. for the Thank questions. the Congratulations on taking and you updates today.

That's that going the Michael's around OTX-TKI for study me you start the for guess, comments expected just to back one bit be would the I can elaborate design. guys Maybe study would U.S. little the a So, on in first year. next

specific yours week I does that in thinking about this to very want set that be any And of get seem just be appreciated. data around kind this said, or that earlier later out peer not for them. And reasons product in didn't stage studies. of had U.S. how terms in data thoughts Just that might product That how horrendous. a terms consensus, viable Obviously, it think guys stage with does company general thinking development? looks a But another that anything a of for the study. you what of Thanks. just space, later stage about first to Or would the inform are you competitor. be of a to you're how that

Michael Dane. is the question. for Hi, Thanks Goldstein. This

that OTX-TKI on U.S. to under being pathway. starting the is this the IND the study we're study you're mid-year So, conducted planning study referring year. exploratory It's that

to eight an patients receive along drug to single for anti-VEGF to XX placed will need with we into to OTX-TKI changes three out at into be for been every micrograms, we one aflibercept OCT. And previously looking trial XXX treated. And will weeks. vision. be aflibercept be receive compared we will that'll we're looking And in a will to drug using get and the that randomization. implant those looking looking subjects -- retinal an And randomized follow enroll of Patients that at will group be induction. So patients anatomy with the have a to

So state. there'll state be who can is but a -- at AMD start dry we'll of at in that the implant them wet in being maintain will looking we patients with what Obviously, be looking single And for durability safety, microgram. or dry XXX looking started effect. out the also

single that a in be with company, as is vitreous, the other where the study. You system we'll is a obviously, delivery the opportunity the that safety believe migrations to believe our study looking delivered not was well. system. into really But with you recorded mentioned we other in had the we the that that that there see drug implant at really And to our related different that delivery data saw from company was

Great.

the And of sorry, the duration what's study?

patients be year. out we'll for following a So,

Okay. you And study later exploratory it CPT what result companies is starting of from this later any Do do stages, comp, to how you the direct or of kind therapy, stage at your just see in you parallel is terms study? pivotal in not approach are study design still have in would stage, thinking terms a see of a about but studies. to the of later actually some gene

are studies. Yes. of I mean, haven't we say later would number options But a I on for stage the there made final decisions table.

the back queue. you. Thank I'll in great. Okay, get

Dane. Thanks,

you. Thank

David from comes question Jefferies. next Our Steinberg with

open. Your line is now

had thanks. couple Okay, I a questions.

But terms use label is a First, aren't right in I what do DEXTENZA then have of insurance? indication? think have other you patients for on? percent on off curious, -- now just for I follow-ups. know you a allergic And Medicare doctor commercial business your from October the any Thanks. also couple your really Secondly, versus the And of said. in that conjunctivitis, sense calling of your reps of PDUFA there

Yes.

which I Medicare same we the both think can from launched questions is have focus answer in the answer, ASCs. we D extraordinary patients Part on that an with

with have start environment So approach indication, ocular that get a in for and and we very majority product from Clearly, expect sphere Part lines, said, for in given we that the to and are disease. -- the we -- being not reimbursement we D. vast advising that in ophthalmology so allergic both standpoint, in the the really see moving But the go the idea surgical hospitals little office the usage of label given outside conjunctivitis. our people Medicare when off paint the bad edge they have experiences surface we will our into is we the don't

it. then, just a And financial of Got questions. couple

you them the in $XX you're when And being upfront? for book And AffaMed? the you received then the the aggregate hits on payments are it run next million treatment they the by to P&L? this future accounting tranche would upfront, but there What's the P&L? didn't million So, Are of Are programs? plus going about XX from use running milestones.

the Hey, question. David, it's Donald. Thanks for

recognize turn to regard sheet. million the that. and I'll down on in to on in AffaMed the accounting that regard U.S. product, over And is maybe addition record you'll around commercial future. ratchet to either Anthony, deferred when to revenue question revenue with begin the with to begin will deliver the to back And the it clinical $XX the we and/or we the So balance see it,

doing regulatory will within we They they And the -- issues China. clinical the handle be driving trials. will be Yes.

line. Patricia, to So whatever works you how China. add may sorry, they're to clinical driving firm in it about that. regulatory a you're the have in have standpoint from work need Do on I'm

No.

they a spot I you've say, think on. hit As

for So actually be Ocular the holder Therapeutix China. MAH in the will

submission the would positive perform milestones we once get from Chinese So the and authorities, actually then. place feedback additional after take

Okay. lot. a Thanks

Thank you.

Our next from Sandler. Piper Catanzaro question comes with Joe

open. Your line is

on TKI. Hey, progress up my taking exploratory if guys. could Thanks for congrats on I wondering And here. so I'm the for much the all follow questions. IND

previously you guys what the that I that the expand have XX additional beyond think patients trial do data need you At data think just potentially ongoing you it Is for actually from that? have that opportunity about could U.S. triggers initial from Phase the some what the point trial? Or to patients. And within treated FDA? the X? with will conversation you spoken

this the Joe, you is for So Thank question. Patricia.

So, exploratory plans transition traditional is do do the in to to to this. There from to that data with we IND FDA talk about the an compile a a be to able intend have IND. for order to we meeting need

to hoping a we're later and set have So year. this additional plan information

should expect to And it. -- see out X you next the wondering saw Got the OTX-TKI. when we Phase And there of what we February? we I'm versus can in for Okay. trial back what expect should update if

Its Mike Joe. again. Hi,

So, we've the I think we every ARVO or that we months And early has when something about give is updates that for said, look cadence meaningful been been say. to would pretty have something four which consistent in the around data three May. meeting,

of one a could Okay. serve potentially the Got Phase it. one are But OTX-CSI, one on just powered X? last is trial in there And like it if that X as studies? expectations Phase squeeze I any there registrational that could

great Phase study. question. a It X powered is a X. like powered It's Phase like So, not

XXX planning are more the of enrolling in phase we subjects. study XXX on size approximately If three, was patients. -- that we're is a like So it general

said, primary you order to that get is and tier and here regulatory with So improvement signs approval, well in at production. adequate the In symptoms controlled into to looking need trials. generally endpoint show

control. the tier subjects exceptions vehicle also such need and a increase case, that of certain data. don't One the you And millimeters symptomatic can to greater show is production percentage of an of in in XX show than you

answer to -- possible that in show this it's a statistically to you question improvement, see would is, not could we but your trial that significant powered it's So

helpful. That's Thanks my it. for taking really Got question. Okay.

Thank you.

Thank you.

from comes JMP Wolleben with Jon Securities. question next Our

line Your open. is

Congrats afternoon. on Hey, the good OTX-TKI all some questions. on progress. Piggybacking the of

You with the milligram XXX I mentioned study. milligram in on three you XXX inserts And change kind single might could that us going your saw you you're in moving current was of be next walk to a through the to insert the that study? how observations thoughts hoping

great It's Thanks Yes. asking, a question. for Jon.

-- that -- out and which And of we're trial implants And better is a than drug U.S. we -- the means in of that, Cohort design, there's similar forward it three. three But XXX and higher that including going better the release day per XXX X. we was trial, a which all of. moving but microgram administered benefit, turns commercial microgram we larger -- having a we gradient microgram primary which single obviously, rate as that product the concentration to essentially XXX drugs is think implant that's actually actually current that for So group, dose, a in driver by are one the higher. To concentration time. a the a implant have implant, to secondary is there's the diffuse a use do out, at the is that, that having drug for

XXX I implants a XXX a implant us. dose of three think upside per the to from is that potential microgram is single delivery escalation. lot microgram perspective, the And from for that going day So dose

conjunctivitis opportunity It's interesting. how available. then and with was in Obviously, hoping I about paradigm to treatment the you're could And it? changing DEXTENZA the be the you allergic thinking going of discuss you're

So I opportunity, the about as can any you the for as move you picture, Therapeutix far what setting. realize how investment to means big was that? Ocular it into to about think talk And office then incremental hoping

allergic Mike, of the I'll the and sort medical side talk medical large it. secondary us that even can of about an those seeks for I slice their there's for then by guess, of about conjunctivitis. attention aspects slice conducted are first, Clearly it population, massive business that talk a and

a a going payers reticence use to DEXTENZA allergic of for your large among bolus that to conjunctivitis there's treatment expect [Indiscernible] patients have to some So out be widespread of patient. there's of product we But the there. have like

going are refractory at So go already segment about who the conjunctivitis. the anterior ophthalmologist planning way and with is than allergic targets we're we allergic for greater on surgeons, conjunctivitis where treats where first to overlap or XX% a there's it positions seeing

be of with portion environment ASC a So the in office hospital the in and that we in both in overlap, will those physicians.

is different bureaucracy So to within note the payers pay is the out products reimbursed. dose. of than the of that promotional it's But the type expenses. of with for drugs, D who had the discussions with actually environment $XX,XXX, expensive that in allergic $XX,XXX payers payers conjunctivitis pays or and won't per will medical or the payers start do part that require very, the news that benefits approve bureaucracy immediately an important that Part the building good that platforms benefit very will we see sometimes increase we've type where our what or part The pharmacy for the be is medical upwards benefit products. approvers And in

same foothold, sector. be both Venn a actually we'll conjunctivitis us allergic we practice. have So filter confluence as we the in expect that AC out, add promotional resources environment. allergic get do will our appropriate targets be patients to haven't to patients the probably build is as the But be where reach And we'll diagram need on in But the pushback our expect will targets office we the same had it the we and to more hospital initially, getting the out. to we at price, with build order in surgical out so that looking in which broadly Once to they conjunctivitis. we appropriate sector physicians

Mike, want something to know, So you I add that? don't to

clinically, well. A the of say, of steroids don't commonly risk of it some it because use for work do They related abuse, lot They chronic end exceedingly of patient adverse to it we more conjunctivitis up there. meaning, keep allergic Then I'll it, in office, gets We do home. the you with take does steroids. using use just well. events it. it the works

of as now stabilizers ocular think over counter. clinically therapies, you antihistamine/mast the allergy gone I the most current So, cell know, have

weren't the office. physician extra the no counter. also DEXTENZA steroids. And into steroids. It them topical there give available So preservative with come that's that They we think are where free, patients would administered advantage be the fit reuse. ordinarily approach patient free, -- adequate. We'd preservative the in Those commercially try those the and could of couldn't over has being

pretty proposition So we value think potentially there's here. a significant

helpful. Thanks very the taking questions. again for It’s

Thanks, Jon.

Thank you.

with Yordanov Company. Our & comes from next question Cowen Georgi

now line Your open. is

Thank questions on and all you progress. so much the for taking congratulations the

next the is even a patients XXX, which XX%, even faricimab question, So broader up injections to with I with of anti-VEGFs Kodiak, frequent XX% guess, generation a very and starting Roche's, XX% then could once once month. combination? Or in require KSI therapies? in every used And background the Do specific every guess, questions? actually month, that more I a couple anticipate be you have other such OTX-TKI of

about a lot as holds that a question. more of seen gives great drug, And very safety it we subjects to this strong and and more enroll us flexibility. up, We've learn more if a profiles It's Yes. date.

the that not really a that's anti-VEGF about using we the All response do of in administered to OTX-TKI, things with does much your get question the vitreous. great is office, that means, displace as nice same volume therapy. One is the the you techniques if great. OTX-TKI in And without

problem. wouldn't If breakthrough, you for to some use that be needed anti-VEGF a

there worried the will helpful. then X you you it. be an That's fully this goes has been could that on that mentioned, you driving has a know what is the issue be on response? And not And implant months. which demonstrated re-dosing? it question up Are degraded? Got regarding subject, Do Cohort to XX this

So another question. great

and is in durability in we little XX class single implant of nine earlier, a And half seeing effect we with which one one effects more a see an does implant implant, of have implant, put its are that I to When the other than the months. patients. one that So, on applies, longer about some degradation. in we implant the bit mentioned a

of a the And additional once explanation. could that, so also the be a need be patient time. you've for got to therapy you've an period sort for of It that possibly eliminated could could state, dry be

we nine about a implant, XX We see how to need that more and we go to to the out. we really see patients. a plays but to half So single of as durability again, But, need months. expect

NDA eye Got your program, risks glaucoma for indicated conversations road? the the a lastly, to you Was successful, re to I decision major on Obviously, submission? rather would the for was head-to-head And supplement perform your show that is then need And based on to for label have a an is the you with reducing, And plan be what with allow against is Duresta. commercial the something dosing? guess, kind or that would sometime of -- it that setback do the drops? it. everything the if what down to helpful. some than influenced It initial FDA,

question. Great Yes.

So the there's X competitors actually trial. two Phase in active

the are subjects OTX-TIC So prostaglandin. a randomized, other eye as said, of to But or Duresta the doses of eye. one will two receive one in you topical

as Duresta well have you'll eye both in as comparator drop comparators trial. the So an the

also corneal changes date you cell related implant as direct with measured single believe counts, our single meaningful the We epithelium a or To note, to so lamp. observation implant. As limited a have in not effects any seen we the to epithelium. that's corneal with on their measurements is label direct pachymetry functional like by

show get in will in see order So we able discussion, do obviously. the but repeat with Phase need we to have dosing. And to to what additional we X, just will not FDA to dosing, we discussions repeat be

much, so Thank Goldstein. you Dr.

super Thank been helpful. you. You've

Thanks your for questions.

Thank Anita you. [Operator comes with Dushyanth Our Instructions] Market. Capital Berenberg from next question

open. line Your is

have dry disease thank Congrats eye regarding for CSI and the taking a And here good you the few I on DED. my progress. both candidate, afternoon. Hi, questions.

And to acute acute conditions patients have happy expect back patients same to one us with wanted know be just eye terms how And you the size? population condition? maybe patients? the be more size remind having of chronic pushed last sort Do is implant? the we sort in for Do terms being designed probably weeks. of I might DED terms was the to and regarding CSI think not eyedrops conditions? the candidate there the of of XX know, also is design, you in -- designed Just of an acute also to the condition for as the the in Could dry

Okay. Lots there. of questions

we as have programs. So dry you know, two eye

treatment months. product for designed is there eye. three treatment say dose the which are release two disease eye weeks then dry a dexamethasone to of with the I clinically, So one low three acute will four designed of a really common, But dry is and chronic or three which acute for to topical times dose a are dry OTX-CSI, as is -- that dexamethasone sort And chronic year years, that lasts think for two cyclosporine for OTX-DED, many patients. or a low -- anywhere And treated there eye we've are for fliers, eyes these disease. about off with you these one we know, these dry of know steroids between drugs, pretty happening label. also patients for we

steroids the with with one do apply is there's The really that that they of of as which it's of risk some the chronic won't product you probably We The with is mentioned opportunity interesting And it'll now As here. for regulatory know, -- DEXTENZA, this I risk as think how things dry OTX-DED is therapy. eye. be not an path. treat to the effective work, that, they approved out product, abuse see gone we work, most ways has through plays space. in can mentioned

And it's patient repeat do so, in having physician product, hands, can't by administered dosing. physicians the the a

In preservative the free delivered also addition, steroids here fashion. that a in is

two for We weeks, three of release released formulations have one and two is for weeks. is the to One different designed OTX-DED. designed

and disease occlusion. the eye both with basically one The occlude is the punctal products, plug. that we dry is performed Punctum to currently other that treatments for both CSI main advantage the advantage, a hydrogel DED huge of component And the use of the Punctum

drug release the products these of both of occlusion. punctal and benefit the getting essentially you're So of a

patients, occlusion Yes, part used be some will of So many therapy. to dry push of to many, about them as your back? pushback whether some punctal from having there their but have we may question been

be I that -- patients those very obviously easy it'll to think be so, accept. And will

was And more one just That question. you. Thank helpful.

Just regarding AffaMed. receive will the milestone from payments that you

something you I that. Is launch missed breakdown milestone? part between be a if can Is the would that development received versus the of as there Sorry, milestones there discuss?

We out laid detail. in Yes.

go You ahead. want to

No.

one. that I was fill think you Patricia, that Patricia, can

Patricia, you go ahead.

Sure.

other clinical And of milestone the regulatory the then for markets. and several payments, there are and success the milestone with in clinical approvals that for do there execution have programs, four milestones to development different So payments are programs.

milestones So well milestones. that's as regulatory really where both clinical the as like different

royalties the in there the in [Indiscernible] of milestones into getting All-in-all royalties team. and excess significant

be for Great. That'll Thank you. me.

you. Thank

Chen comes question from with next H.C. Our Yi Wainwright.

now Your line open. is

questions. sequential you surgical in with volume? first new recovery there by respect was My How the growth to was it much Thank my driven XX% question accounts? taking of is up for And much how head driven by of of units. by DEXTENZA

think probably XXXX, none is there's is data surgeries about The I recovery be that X.X. now performed. of that cataract XXXX, And volume. in The by to average million surgical it still cataract down. latest driven about seen surgeries probably seen X that the X.X we've was be are million performed. That's of projecting against in data there surgeries about will we've an and

number So of Clearly, to we're is in experiencing either or in yet ASC --certainly seen in the of is February market. slowing we've still in growth closing. happen. this Clearly, rebound down year, double a digit January

the gain country but back an been is up now, cataracts those some in only share So get total really we're number of see March. of Even has innovative wake accelerating. still though to the and starting to surgeries malaise, the although starting

Okay. At guidance? what point would some consider providing you revenue

should in toward. guidance there's be we reserve the concepts what we should of able we quarter And right the in unless a first give would the We mean, that excuses I be net run unforeseen. that's to second out going consideration. probably our will normalization not guidance going quarterly we always COVID, not some in will then But give where we Clearly, is forward. that on sales see that do think to something moving after it quarter, I forward. that. happens expect We're this be to

Got it.

the trial to is your chance by OTX-DED OTX-DED, of as patients enrolling the question XXXX? DED and the trial data OTX-CSI So as end data, fast report

Hi, is This Mike. Yi.

enrolling started September, that's last in able And trial we change we're why the to started than cadence faster patients OTX-CSI enrolling the guidance. expected. has OTX-DED week. patients So and been

things us going on change early too far that. so are to able it's I to And be think well. guidance But for

you, after of right just is OTX-CSI if CSI the trial earlier. now enroll opportunity did, been So we're move the things they've patients And Obviously, shorter there half XXXX. saying endpoint of first to for to is weeks quickly, follow that way and randomization. DED the trial, two the to patients we remind In months follow the two trial, We for months four after randomized. months, primary four

So shorter trial. it a is

four so will see, know the will we over six next And will we to we more weeks. much

with my And to last it. respect is Got question OTX-TKI.

commercially what's of in number For six lowest that to months? of what's remain of your terms at free successful become the be least that rescue -- product. for a view, lowest patients the percentage In percentage

mean a longer. our What Yes. -- of simple believe patients It’s and And mean? with It’s DEXTENZA is what a a and And complex. be nuance question with if is drug is a is things. I nuances or what be would lot number to rescue it. release really the months of and around drug rescue sustained target exciting six activity it's would evidence the of we other can a get half say to biological what

target. I think that's our

even response higher see think big I to better. that think becomes think rate really I that a But obviously shorter. we that's and half or its But I product the six out there's a months show can longer, a patients if -- if product. we

Got you. it. Thank

Thank you.

participating. Ladies this concludes for today's you. and conference gentlemen, you Thank call. Thank

disconnect now may You