EYPT - Earnings call transcript Q4 2024 | EyePoint Pharmaceuticals, Inc.

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Operator

Good morning. My name is Michelle, and I will be your conference operator today. At this time, I would like to welcome everyone to the EyePoint Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Development Conference Call. [Operator Instructions]. Please be advised that this call is being recorded at the company's request.

to President call of and Please ahead, like Elston to Pie now go Vice Executive Chief sir. would turn over the George Point. I Financial Officer

George Elston

today's all and Quarter Year XXXX recent joining you EyePoint's and Full thank results developments. and to discuss you, us Thank on corporate conference financial call Fourth for

Dura today Officer. corporate with for begin of we recent I Jay updates call clinical questions. the is discuss View a quarter Jay ongoing for year open XXXX President Duker, with the Dr. me financial close will With and results, Executive the and commentary and Chief will fourth then your full review will trials on and

recent found corporate can A the morning, release the website, the of in developments. issued Earlier release this detailing and we copy be Relations press www.eyepointpharma.com. company a tab Investor on our results financial

of the will results factors, those harbor our Before Form including XX-K, discussed remarks the constitute forward-looking we or other with I'll plans those XXXX. on is may report These in made regulatory financial future Securities future. indicated filings Risk materially Private the and and that various important section in a you for candidates, Actual developments differ lines, annual and Act of recent have and the begin SEC and of file formal Litigation our and products by about we statements prospects. we as our time most from today our in clinical may potential which make on with under that SEC make of these forward-looking result matters expectations, statements Factors the the remind the purposes the various comments, projections our product statements success provisions safe include of Reform

statements forward-looking only. of views today as our represent Any

views change. so these at any as our forward-looking Therefore, of point as to these views While to not rely date future, to any obligation do elect in we should specifically even subsequent disclaim on some the statements may statements forward-looking our if update we representing you today.

turn I'll Executive and over Officer Dr. Duker, President now Jay the of Chief call EyePoint. to

Jay Duker

Good George. was everyone, bringing on with execution delivering us of for results severe closer continued patients year exceptional and all XXXX joining a on EyePoint of our us. diseases. for fronts, morning, to and you life-changing Thanks, bringing thank retinal to treatments goal

Phase III the of only DURAVYU both delivery indications, of X indications. in delivery with On today's data will TKI with care. call, II the why a mechanism or patients' and may DURAVYU we an robust for action differentiated diabetic We've outcomes in blockbuster XX-week wet we DME, we standard program Phase uniquely to or degeneration is III patient lives second are these results reported potential highlighting opportunity. a a and our the drug macular improve X-month of supporting edema, multibillion-dollar And new investigational ocular advanced best-in-class wet macular Phase in age-related are we've data strong review trials leader improve therapy, positioned AMD. positive compared sustained how with sustained to therapy in clinical in into how

rates the that Phase AMD in With surpassing E and we clinical ongoing This of trials and safety want pleased trial to XXX expectations. enrollment superb sustained interest profile, both treated enrollment wet II the margin. delivery of X with bioerodible Phase intravitreal AMD trials, our patients we substantial DAVIOX the the physician wet consisting III I'm wet coupled the LUCIA the with by X trials historical with the from over beginning continuing our data already I by AMD technology Durasert patient DURAVYU. saw of safety our comparable approved excellent a pivotal date, of emphasize to to efficacy strong largest in has report clinical FDA data and significant driven trials. are of in exceeding LUGANO products Durasert safety with

The XX% is LUCIA now well over and ahead well. as of enrolled schedule trial is the LUGANO trial tracking

first approval investigational program completion We pathway anticipated reach half patients represents submit continue drug XXXX. positive. wet or In enrollment trial in application, design to and of wet both space, AMD first. being anticipate the results the the LUGANO LUCIA be tried to to and The X-month AMD a allowing expect to should of top with clear in regulatory a new line XXXX sustained-release we trials potentially intravitreal noninferiority NDA, us of data and second in true the

Our broad interval, thereby label product allowing providing the to optimal with market patient-centric dosing design capture and trial flexibility more an should share. physicians of enable us a

trial positive preparation our part As We success, DURAVYU TKI with II primary with end clinical VERONA efficacy, DURAVYU from batch and for of DME registration Northbridge, the to our our manufacturing program online, program. support facility secondary in now reported establishing Massachusetts, for sustained-release data VERONA an commercial met NDA only safety active filing. underway is recently firmly DME. key as subgroup Phase DURAVYU an and manufacturing points in

discuss we This in no on solid DME by a the a in this more data, detail year. cash call. an Phase end for this hold the second fourth the investments of offering follow-on I to of in balance Phase We pivotal million was market $XXX a with XXXX meeting oversubscribed equity around ended in sheet noteworthy FDA a expect quarter based position. has compelling the But II need quarter. bolstered large in VERONA is a design data We with the of sustained million currently delivery $XXX later remain II significant that and will options. in financial debt. trial and

thousands its kinetic patent-protected release with of Durasert of science. for tens E. of and X uses in system consists eyes comfortable or drug for bioerodable Durasert kinase record. safely DURAVYU X across E order delivered bioerodible products, physicians tyrosine Turning proprietary which X the both Vorolanib, of this established formulated that a delivery delivery to at are inhibitor, been matrix least TKI, sustained FDA-approved our via a is months. best-in-class to Durasert has safety allows patients and exceptionally meaning

kinetics steady small at rate, is so means delivered an Zero-order the can a tissue therapeutic that that constant exposure. give payloads drug with extended effect

uncontrolled is selective In just Vorolanib is allows and anti-VEGF the Vorolanib is DURAVYU for E It of another potent Durasert another brings addition, VEGF-C that in blocking all diseases of treatment and immediate prevents through by approach the design not retinal to VEGF, bioavailability program. including drug blocks eye. of anti-VEGF D. TKI VEGF-mediated and isoforms of intracellular new floating a a free and not VEGF receptors. therefore release mechanistic all

and dynamics. development, biologics consistent sterile ambient animal not Blockage by standard temperature. retinal validated antifibrotic a and as at intravitreal retinal DURAVYU It injection type programs has receptor in other block have neuroprotection it Vorolanib X. prefilled syringe is a vascular with in model X benefit currently packaged and however, and of DURAVYU, approved a current blocks the type similar associated biologic PDGF vorolanib demonstrated injector. achieved an is exposure in may in of standard tissue does instability. receptor. treatments administered shipped office stored anti-VEGF Unlike detachment current the to is A care retinal can the with practice with be sustained-release DURAVYU physician's the

in protection strong us for both and of have to flexibility us patent States United U.S. protect partnerships. with the innovation We the our This outside DURAVYU and our allows provides strategic

great order patients action, profile, an In believe is distinct safety excellent for retinal X an protection patent for delivery microdose DURAVYU sustained of for X convenience as a diseases. VEGF-mediated summary, months, physicians, kinetics well least mechanism option with positioned and treatment allows for with that excellent we at

the longer supplement much control. letters DURAVYU versus subfield as and early thickness OCT gains meaningful or and gain X.X were the to demonstrated BCVA, both to This efficacy primary anatomic for versus CST robust with central Phase DME. II clinically eyes, than its TKI. We safety sustained demonstrating those positive announced trial immediate recently more arms XX% XX-week in early, achieved and and improvement XX.X first DURAVYU by improvement end a and a aflibercept of aflibercept control visual the corrected microns bioavailability drying more acuity, point of we're Turning DURAVYU of the X.X as with and week on differentiated compared sustained-release milligram VERONA observed best to time data X DURAVYU the clinical a or visual measurement. and meeting profile effect in of represents baseline control. as an

with supplement from free safety data events the of a BCVA Both weeks milligrams related VERONA through those reported with control demonstrated letters control supplementation for significantly group. XX XX. eyes control group. versus serious we favorable week the to presented trial and the clinical treatment for anatomic no only baseline tolerability Phase aflibercept or subgroup compared date. Yesterday, to compared DURAVYU arm II and a that went X XX.X X.X BCVA no analyses better adverse improved systemic improvement letters to the in DURAVYU DURAVYU ocular aflibercept profile The that patients improvement had showed

versus on with only unsupplemented improved improvement months positive and driven visual XXX aflibercept of data that over of DURAVYU II for confirms DURAVYU control. concomitant had microns were by This from result X X demonstrated milligram also lines an acuity XX agent improvement the the eye chart. CST as microns trial active about VERONA Phase X.X continuously structural the the released that the eyes

regulatory positive a II discussions around with ex-U.S. and plans the Phase agencies The program. the in engage U.S. to solidify our highly plans to pivotal data supports

maintains patients without label. company, of in wet III typically the on As program the every stable And it that wet number are improvement our is anti-VEGF represent to of allow average wet patients product AMD United In goal significant AMD, a sacrificing a completion for for months outcomes. flexibility the that vision majority within provide the visual current treatments compared we the our AMD at of on reduce States. to may to and X dosed highly focused Phase practitioners visits the anatomy X-month every This successful could a retinal DURAVYU. are

driven are second have provide XXXX. previously completion is pathway investigator and AMD regulatory enthusiasm X essentially recognized by in our a design. enrollment in rapid trials pivotal both wet Enrollment the positioning for received identical success, trials, is expectations. trials that a established trials with with X-month to LUCIA, Phase The to of rates Both blockbuster clear As our familiar in and become exceeding noninferiority an III mentioned, commercial of enrollment half franchise. date, patient potential exceptional to trial and and expected global and redosing ongoing LUGANO review both

delivery our dollar product the multibillion technology, progress a by sheet, be not clinical reflects as demonstrated opportunities, incredible we've our Durasert these our team entire to thank on XXXX. like with role for ocular our in trials. further the the to in strong dedication a to execution team the made you the close, to On DURAVYU representing well delivery organization's EyePoint along possible. compelling that E and advancing note, start are strong to their I'd commitment way have improving would also our sustained To to I'd pipeline clinical an diseases. capabilities patients' Without our established we patients balance With all reach investigators ongoing best-in-class and from The lives. serious to drug impactful year entire the therapies milestones patients suffering and retinal leader sustained bringing and participation like thank for ocular

will I turn over call financials. George George? to the to review the now

George Elston

Jay. you, Thank

the XXXX As of oversubscribed driven and $XXX sheet, $XXX million we noted, our cash with in with million follow-on Jay ending in a year balance an October, financing cash strong investments. and stewardship very ended continued by

for focused the be December today for and release issued in on high-level comments full this the the financial included As morning, XXXX, results review a X ended year the months quarter. my were press XX, will

to compared XX, for The the quarter of million. $XX.X for December XXXX, revenue net the compared was ended product quarter to quarter XXXX. Net total million XX, ended XXXX, million was XX, quarter ended For December $X.X ended XX, the $XX the net revenue December XXXX, revenue product December million for $X.X

We Pharmaceuticals, agreement a immaterial XX, YUTIQ levels accompanied expect Sciences, revenue ANI continue in will net the of U.S. supply no of as May commercialization ANI nonrenewal we partner This Alimera longer product as follows be now YUTIQ XXXX. to the that to to our of sale rights at XXXX. supplying

manufacturing forward our rights. for in trials filing period royalties program strategy, million recognition product of our the review The license driven with XXXX. support to $XX.X launch. the Consistent Net by in of XXXX, million our fourth future is clinical revenue compared XX, and YUTIQ totaled NDA on $XX.X the and revenue ended December focus commercial decrease and to corresponding deferred quarter was lower from from collaborations primarily

totaled nonoperating in to Operating expenses $X.XX DURAVYU. increase $XX.X per income primarily prior was for XXXX, This XX, period. the driven quarter million was per compared totaled X year trials the million the loss for prior the III Net ended by or $XX.X $X.X December or period. $XX.X ongoing million and year loss to share, a million net million compared of for $XX.X net share $X.XX Phase

XXXX, YUTIQ the Turning to was collaborations EyePoint's the its compared full $XX.X XXXX, $X.X December $XX.X totaled ended revenue net from rights from period Net commercial the Total was full in product the year Net $XX.X to million. decrease the for year business. This license XXXX. by product year December in sold million and was revenue corresponding XXXX, XX, royalty the in million exit million year XX, million ended May December of for XXXX. XX, XXXX, million ended of to compared product to revenues full driven compared December XX, for year the completing ended December XX, net full $XX $XX.X revenue XXXX. ended for

a driven primarily of The the license rights of increase product deferred was in partial revenue from year versus by full YUTIQ XXXX. in year recognition XXXX

costs of to $XXX.X Operating year increase to XX, Phase in trials $XX.X in million costs of organization, compensation, XXXX, attributed increase million the for million year $XX expenses versus III a personnel DURAVYU, full across ended This clinical $XX.X the prior increased trial of December totaled related of to $X.XX $XXX.X increase $XX.X year was per the license loss million for clinical totaled primarily period. nonclinical including and a stock Net million and noncash the sales in discontinuation million marketing million, increases in $XX.X period. of XXXX. by nonoperating YUTIQ or due these were and to share prior or share net expenses in commercialization DURAVYU compared was net $XX.X income expense, $X.X $XXX.X per other decrease offset loss the $X.XX million million million a

$XXX XXXX. Cash, investments to December $XXX million in XXXX, compared cash marketable million on totaled XX, of XX, and equivalents as securities December

III wet cash plans on based We on XXXX. enable XX, for expect into investments currently expected and DURAVYU data in equity to access capital XXXX year. us will we line fund the and the cash and operations to December XXXX, top AMD no Phase solid markets position, Accordingly, beyond this have our

capitalized pleased remarks. through In EyePoint's are conclusion, with advance to program AMD. the progress we over trials well in are to turn for incredibly now back will III call DURAVYU and I Jay closing wet Phase our XXXX in

Jay Duker

Thank you, George.

include the data U.S. meeting trials half end we and upcoming catalysts space. in the of EyePoint our and Phase XXXX story LUCIA Top beyond. and discussed, we've trials be of and Key enrollment Phase III guidance, III disease strong continue milestones XXXX plan to trial As DURAVYU clinical FDA a the for superior wet the a and leadership focused continues Phase product these in completion and first in execution AMD the retinal We've line to with accomplished of XXXX. pivotal an this of second with efficiently and our in clinical in III aligned to Phase DME. of DURAVYU II LUGANO discuss in

lives execute and for solutions on This the improve an with with continue retinal remains we vision positioned are of patients our transform the long-term incredibly and innovative treatment as serious both to to well EyePoint exciting time milestones the landscape to diseases. upcoming

over I turn very call operator the all the questions. listening this much for now you to morning. will for Thank

Operator

[Operator Instructions].

from with going the come JPMorgan. to is Romero Our Tessa of line first question

Tessa Romero

AMD program, do remind wet are XXX us many across how think overall And of in you Or over clinical our been many you have of I across open? activated how far? your to so the aiming trials open? sites sites can you pivotal For sites LUCIA, your trials, January. as the U.S. target at conference for have activated were

Jay Duker

the Thanks Rober, all, Ribeiro, the Dr. you and ex MD answer trials, questions. Officer, also first Ramiro wet our those sites U.S. planned. call. questions, on open want Blue about who your do Chief like current is our introduce for I'd of to sites Medical to

Ramiro Ribeiro

question, Thanks, the Jay. for Thanks Tess. Yes.

very the as think strong numbers, to have have activated most yet most activated, that activated already with have enrollment we little our activated. not especially pleased we show are that sites the the in are of U.S. we progress But ones. of centers be the the are of like the So ones already the bit and that I words sites studies, process with line longer a The usually we more academic takes

ex between In be to later per XX of and should have U.S., study, we are terms year. which sites planning this XX coming

Tessa Romero

in clarify sites trial? currently you numbers your Can active of just each

Ramiro Ribeiro

active we XX per about study. So have approximately sites

Operator

Our next Nochomovitz question comes with from Yigal the line of Citigroup.

Yigal Nochomovitz

analysis I like it curious population the it the with milligram the on though have just presented , there. interesting the may aflibercept, with was you didn't strong for as what got was X.X separate XX you just you one could It expected. seems on of comment patients. separation as observed I the if versus the overall yesterday Relative very, had much the was one to trend in a that very supplement. X.X

Jay Duker

analysis, Terrific in Yigal. was powerful think the And in of question. shows particular, I Thanks, patients really that non DME DURAVYU again, how the you of this subgroup subgroup evaluation the population. supplemented

in eyes and And anything review over less control. the microns the made else than fluid, was other letters the group. improved whole in eyes it that which XX significantly without than XXX weeks the these they had to So XX were unsupplemented our better

using what essentially pivotal trials, what response doses. of And current X.X interpret we in dose pivotal using those but in go-to-market the in what the our and the the numbers, is we between on evidence we is. X.X we're dose a the is plan some of is variability X.X individual I dose course, and it -- we're with dose think seeing response. what within I trials represents there -- this But think

the dose, that supplementary shows X.X but when is slowly that it meet criteria. you vision by clouded losing And what gaining by DURAVYU that So this supplement were it fact not rates the in those works milligram were well. achieved the free eyes fluid, population, exceedingly the works slowly didn't or were

those curves, fact, at you In look are when they flat.

I So point, effect these the group supplementary were in reached really eyes. one extremely the were or the too, bring that perhaps ceiling much supplements a in that will the well these up fluid eyes didn't X.X we vision exception the of have to that suggesting most with change controlled. seem

So analysis X think yes, the with dose there. very it's variability is to explain a that doses to between bit I response think, strong. a individual I try the again, And differences, of little

Yigal Nochomovitz

the there line year on of XXXX, III. little provide this Okay. just which Phase the sort III on be come later Phase may where timing granularity we very the one perhaps of a data. half one more a top And you'd expect point quick to of Will bit able

Jay Duker

Phase The III top line data, sure.

we as you think LUCIA. approach I give certainly last granularity patient be we able to will more in

will that obvious. be think I

some that. expect give the expect half yes, So year second around do sometime, you we of early I more granularity to

Operator

comes the with from next Our Yatin Guggenheim. of line question Suneja

Yatin Suneja

there able now, versus right I WX, type be they the are enrolled, that I comment but differences you are you are the able characterize just you to mean anything is can patients how on. now of to recruit study know XX% might

that's one. So

time the about one load we analyze second bit thinking to standard development that are maybe III, have now expect you Could side. from talk you care. mean sort especially on a how should you Phase about a what of data. little plan, the the more the of The I is DME

Jay Duker

Thanks, Yatin.

question, First, cap that at we said the And that think level, treated the population, we're reached about the XX%. capping a I have previously at first in high approximately patient have we LUGANO. patients and

at trial treatment-naive that are obviously, XX% point any in since this patients, be patients. don't over enrolled, more previously expect of majority enrolling we're patients. the to we treated But So

we've of we're recruited. understanding really kind type with where the high-level the at of that's of So patients

of And to the Beyond be details that. kind on that, any done of no yet. any other really don't analysis around there's before analysis are expect doing been kind we studies done

Phase lot With the respect here. we III to have of options trial, a DME

is the have some the need data important questions pathway person us we is around specifics. But know I do. to I to what give think probably this. a options to approval. give was exactly the that we're don't the bit going little we Ramiro agency really -- We yet top answered to robust so you a best But get lot truth the is by of a line think would here more

detail on any So more that? you add want to Ramiro,

Ramiro Ribeiro

Yes.

CVA day think II from I the you mentioned, on data the immediate study Jay, on as show the X. Phase does benefit the

that flexibility So designing about III studies of we DME. type us the for while Phase think results give

results of The which similar right? loading again, course, first is review. we going what We have the this aflibercept, case, would something AMD, for then is of and loading to doing DME But we're to always dose in give X study, option, be that dose to based have for a III wet and we would little sooner. more the the Phase design might from to opportunity on have we be shorter to that results study bit an could meaning do dose review think a study a overall, earlier, efficient, I is the

Yatin Suneja

Could more least help for One forward question. model us expense you George. at This XXXX? helpful. in That maybe the R&D going is one

George Elston

sure, Yes, Yatin.

was really So to the related remember, increase you QX, did see meaningful that the in quarter. the initiation LUGANO in LUCIA and a trials fairly both and fourth of that

I probably XXXX. roll barometer of how good think you a that's forward

on burn R&D and As on are today, again of laser-focused that's the going clarified execution trials, focus those for we be yesterday and to the side. we our

Operator

the Jefferies. of with Yazdi Kambiz next from comes question Our line

Kambiz Yazdi

the Congratulations enrollment progress. on

considered wondering any such information DURAVYU near long glean and and If what was so, While remain LUGANO the differentiate opportunities post-marketing DURAVYU AMD from if marketplace? and laser-focused studies help conduct to further studies to be LUCIA term? term, wet would for I valuable you've

Jay Duker

of most approval think is high-dose studies And VABYSMO. obviously, to we've post point, the the a the wet DURAVYU what DURAVYU AMD. of while, for obvious talked other the Ligand And is [indiscernible] or blocker one industry whatever question. current AMD enhance would already it's against the in value that that whether wet might leader for study I for to run started at and we've about, about think, Kambiz Thanks

In The of free percentage obvious that the reason remains being going against blocker regulatory for sort end or acuity, a Eylea very, instead be X a or the trials, primary is first And supplemented we're to X-milligram study, in to endpoint as point very change doing visual primary efficacy. that eyes supplement terrific supplement X-milligram rate of on time short-term which up would treatment requirement. is the while pivotal a months of up ligand the with in Eylea good thing.

into be dose and to moving seems VABYSMO eventually. high market suspect The Elyea

thoughts strength I sense prove in we marketing to some do obviously X the more have any be ask give longevity helpful. would might on then So us argument. against very against that it our and studies that and makes products. can other those interesting think you would well post-approval we Ramiro,

Ramiro Ribeiro

Yes.

approval. are the on in as gaining course, we're studies effect TKI are could that we have And of compared of blockers. type additional all do exploring as inhibitor the But of to these I atrophy going about to But studies our in TK benefits mentioned, Phase such wet the prevention patients. laser AMD also ligand learning focused think of Jay III just AMD. regulatory

for study. So be also a that's going to looking post-market we're as something that

Operator

of the from question Kim Cantor comes Our Jennifer line Fitzgerald. with next

Jennifer Kim

on and execution. we including what give you Maybe Congrats quarter? first that from away -- agencies next on to come an plans all hoping by to next color you're should Or in the ex U.S. take quarter, DME. meet after? expect both start to with your more update a shortly bit strong both U.S. Can would

then what trigger of about? talking that accelerated it contingent was Is understanding a stage, advance Ramiro pathway to sort on the AMD sort when would that decision pivotal program? takes center that And of

Jay Duker

usual. questions Terrific as Jennifer. Thanks,

a what with details after do in the a what little interaction suspect to we they more agencies and we obviously well agencies announcement past, going with this have are of have and about our type what what let plans the give So expect as around I'm for would how told is public done the written minutes, what we'll and I sync Typically, the hope the Ramiro us. regulatory we'd get for what we've

successful. is not, make people that for the wet to resources continue and company, about financial that, resources put meetings cash want this of the DME we have delighted the is the that acceleration point, do regulatory structure of DME to decisions how a this sure strong be data, anything AMD timing is As make we and to the of risk a therefore, which it's as runway after wet going. We really and going within wet AMD after have with at resources again, to to DME, really secondary principle, first want sure at with to company, are We AMD. both

So with to Ramiro with again, accomplish really hope what the on color any we how over agencies. meeting to -- XQ the

Ramiro Ribeiro

Yes.

of EMA planning the feedback ensure to meeting So to as regulatory gather we we have well around day, At the end questions be both with as globally. the design of the going the are to are with FDA study. a the

So as study agencies efficient. the of make course, if I that approach. think that, going to would from before, I we're feedback mentioned agree they then get something And with propose a

Jennifer Kim

trying -- guess, ask given roughly. split like. what in the high could with talked tapping I'm LUCIA. to AMD about about we the think they study per into think about you LUGANO, LUCIA looks I enrollment I sites of before cadence question is on enrollers should just in Since the we sort if And the the Or there same Should LUGANO X move seen into way? think programs. Okay. through we've wet a one

Jay Duker

sites LUGANO weeks LUCIA. than first do think was We come of X, -- perhaps LUCIA started this approximately, more -- have the patient at in time. I higher expect Remember, slightly is in after it the to So number X over point LUGANO. LUCIA sites on

-- the be little wouldn't to but in call going there's I So it the between naturally a rise recruitment. separation delay,

seeing in though we're the LUGANO the at mirroring what what recruitment we trial. is in rise of LUCIA saw So beginning

optimistic type the we of will in confident enrollment are we So saw be that and LUGANO by the LUCIA. managed

Operator

next Our line with comes of question Mizuho from Graig Suvannavejh the Securities.

Graig Suvannavejh

And the the about question manufacturing, to progress continue. site manufacturing to the but the progress about of can we visibility of maybe get the lot that any something which, visibility and ask a out CMC get that. how we I there Northbridge color in on because talk on into, about the kind is obviously, and manufacturing worry I that of the maybe anticipating you are potentially you've don't Congrats some facility, wanted you can't quality cell issues, to obviously, guess, anticipate quarter. built just your always a I we potential on, year

Jay Duker

George, do Graig. want question? you answer that to Thanks,

George Elston

sure. Yes,

Jay Duker

we going. it How how it's did and

George Elston

great out been Yes, we've this because for Graig, ahead really question, thanks and several for of years. that

our ready facility preapproval I think just last being for and on fall, we commercialization. batches, Northbridge opened square to execution, the registration ultimately XX,XXX remind facility. audience, just not focused clinical inspections state-of-the-art We're foot but

And investment. all filing. specifications It get The has and ready really already to has activities will year didn't our getting any actually was running. really remarkable And the cash batches built start that we to this NDA the involve pivoted to an landlord. support registration to to started site we The done job manufacturing forward a team that site. DURAVYU site -- up team by

really So worked out well us. incredibly it's for

your team execution And early in involved FDA importantly, design that way. we've of the site. has And an to the quality and entire our had mind in had point,

leak product other commercial as to feeling not also have, with clinical, be side of we we're for but successful and the get just support to we're really So prepared able launch positive positive really that data. data on going

Jay Duker

way little tell middle opening. have that woods, the went to walked site a team were it's right may ready a the all the I And and the times. site. I comes which put if out went And think building. before said, inspect of the to sidewalk they we I've the walk obviously the sidewalk when we around sidewalk If It's so I been why inspect. there site, beautiful anecdote focused reflects the about we day, a I the the rainy the around And will out all his area. around have I to an the way a actually, walked I a to was, many are response how around us, to official have I building. head building, and it's of on. X, the and we FDA in a did there's

from time has commercial sure FDA is of site that the specifications. and that putting from entire together running perspective site. expect for up the make on both able this to type DURAVYU and foresight we it supply premium be this will And a to into EMA global to the That be supply

Operator

the question comes next from Colleen Our line of with Baird. Kusy

Colleen Hanley

and Lugano studies, for retina enrolling you're with to talking results you progress. in type all the deviation might the speak studies impact in in U.S. ex sites. seen We've whether versus on expect patients a other a of results. about Any Congrats the standard that in line patients and meaningful you'd GA how Lucia? top difference the differences Can U.S. difference

Jay Duker

I next international Colleen. who, of of the person quite question, me involved to studies. Ribeiro, GA And best X in the to Dr. answer question, Great have course, was that

Ribeiro, So think? do what you

Ramiro Ribeiro

studies more much years. GA this studies many, doing clinical trials difference No, So trial, if think that than was but X were And go working I'm be Regardless, many on hypotheses, could been the reasons really have sure of geographical difference for I if back think across we question. X Yes. the the was are the these of globe, good that the in confirmed AMD there I for mature not the it right? results GA something the wet sites

nailed I parity to our down exclusion global study. accommodate we inclusion think

see I between So U.S. baseline being expect ex characteristics the to don't sites. much different and U.S.

Colleen Hanley

AMD. Great. does On the they FDA I -- have can. of as of That's one on wet margin bound if helpful. interval same do X.X minus quick liters confidence lower the And in the one, DME, noninferiority the

Jay Duker

historically monopolar in how been has know you DME? the calculated do Ribeiro,

Ramiro Ribeiro

Yes.

our EMA, going be previous of So to back but of with FDA X interactions. they be to of in course, for part ask letters and it's the use DME, of you going look if some the X.X%. I our on questions of one But of think it's tend course, studies, to we discussion instead the

Operator

question Chatterjee next of from Debanjana comes Our the line with Jones.

Debanjana Chatterjee

would to. X label compared label guided XX-month [ In every of EXPAREL future potentials that market to X-month how every DURAVYU's ] months, potential terms has positioning, every Ocular

Jay Duker

question. Thanks for the

X-month think label every in prefer. I is physicians what I think, the

levels we think of of that's DURAVYU And I everybody. by quite been of vorolanib months for therapeutic in designed a course, made X virtually market deliver only clear that's research. but consistently to not us how bit by

design, individual and effect flexibility like deliver to like label their we We physicians think label. the necessary drawing vision, help our to that the the that minimizing while and study So injections. tailor and will patients we to visits the maximize maximize X-month our treatment

Debanjana Chatterjee

a The have capture for-to-market DURAVYU way I TKI. the would could you up, -- things the still time be market? quick [indiscernible] I stacking mean, How lead to are over this use follow-up. durable

Jay Duker

on first that's I an to and still it's because -- first that really by of early done exactly market, past broad. Well, we you driven we've believe interesting the an this And X especially had DURAVYU. about years to advantage, course, know. enrollment position to is are we've we are great here position saying In be going today. how a all question for a quite as work think that in that, market we to strongly program And talked there

eventual we right really tolerable now now to that market, treatment data it internally that repeatable, as VEGF-mediated safe, the how and to right is a doing for we closer is idea it is like to certainly is And in with will and closer there argue and so are could the nothing true accelerate that get with launch. closer comfortable get process X-month it physicians you disease a the of shift

of ourselves. So market, I to it out position been people in that to to order retina manufacture at think payers, KOLs entail. interviewing on the we just say the been We've could testing talking spend what suffice X commercial. that we've like that business might figuring hours details the on the But best for forefront of groups talking to the

Operator

Our next of going the Scotiabank. line Greg with come is from to question Harrison

Gregory Harrison

the guidance program? for work in then assumptions that razuprotafib data I wanted pipeline? And current includes and assumptions and includes separately, we what whether what runway DME the for your status could -- And additional when see of is that about cash the to ask or earlier there?

Jay Duker

Thanks, Greg. I'm going those to let both George questions. take

George Elston

Sure.

is our III as of we meaningful I data. guidance on want the hand XXXX. on the cash said, Phase side into Jay So And Greg, to cash other have think

AMD. with obviously, DURAVYU includes our study study DME wet work ongoing itself. the And includes, so for in associated It not guidance and internally our everything an eventual preparation but

additional on we move but Obviously, continue As as activities far our as to it lower that's with -- I razuprotafib that's goes, focus ultimately on really laser-focused enabling move this that that to move cash. and conserving studies an would organization But say for at gone wet priority, to some a there. forward our AMD, AMD percolation year mode. wet execution on preclinical will remains look IND. continues The

Operator

Our next Laidlaw with line comes and of from the Jen I-Eh question Co.

Yale Jen

Congrats on progress. the

Just us. X from

the mentioned then in a And these the you follow-up the suggested XX%. readthrough you market. given sort have quarter question. of that may days first the first be they have is might results a guys X statements? Any X line to ocular top from I And first of The ago, few

Jay Duker

Sure.

not the of in First first reads dependent out trial last patient fourth quarter next the us, this the the doesn't for on and to Whether last market, second to second of for the patient first trial, concurrently course, LUCIA. year, of quarter of that in patient trial. highly in be last is course, affect in run going the year, which was

confident total, as is the confident recruiting, we are we to Once be therefore, will think again, will rate as that we in that and LUCIA we recruit at as we're first market. we remain look rapidly LUGANO that taken

Yale Jen

curious, And Okay. you which small, supplement maybe be That's are reported do just Phase the but which helpful. the you current a able characteristic apply numbers those follow-up years Any to patients and one [ I supplement few patient, here. your III need not subcu study? have more free that analysis. guys needs? ] to very versus ago, is the Great. maybe differences dissected know

Jay Duker

answer Great Ramiro let Yes. Yes. going to that. question. I'm

Ramiro Ribeiro

of already you think I And question. a being good mentioned limitation the the No, study. study Yes. small

little it's are to be patients a So I to which think supplemental X. bit hard we've deemphasized predict going

look once course, able that's a program, we with database III to larger the at. we Phase then something might that be Of have

Yale Jen

progress. Great. very the helpful. Okay. Again, That's congrats all on

Operator

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

Yi Chen

And partner late to potential trial whether III results potentially in the you be target DME do by initiate Could you Phase this XXXX XXXX. III concept? talk a a plan a moving about in what If forward? or to not, this at you find VERONA suggested Phase plan would point currently potentially indication enrollment a have

Jay Duker

much larger it. going but indication might be partnership partner, clinical individually. can that great not the have event, that And in a in DME partner include A a All program say currently in DME development be point. certainly trial And to to initiate that a or questions, we believe plans Yi. in I XXXX potential be have welcome XXXX. pivotal interested really to would it no partnership will we this would in We at wouldn't we're we

than would partnership would to But I something structured time. that much consider said, So just be a I that's as have at we think the right larger it DME.

would Ramiro, target able answer the for might maybe again, think I the you better As that targets. about to approach we be how

Ramiro Ribeiro

we relationship well learnings And think study Yes. lot great the building the I a with of benefit AMD the now. in a the we have are wet having of as sites as

DME they we using So sites, as be very likely we know for trial. AMD wet that for would are one clinical same the

trial. rates, of would terms we be also a in enrollment DME optimistic think for I So

Operator

the Ladies great Everyone, day. a may no am you. participating conference. in Thank does for queue disconnect. questions your and time. at and have This in showing now further conclude you gentlemen, you thank this I program, today's

EyePoint Pharmaceuticals (EYPT) 5 Mar 252024 Q4 Earnings call transcript