Earnings call transcript Q2 2023

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Operator

Good morning. My name is [indiscernible] and I will be your conference operator today. At this time, I would like to welcome everyone to the EyePoint Pharmaceuticals Second Quarter 2023 Financial Results and Recent Corporate Development Conference Call. There will be a question and answer session to follow at the completion of the prepared remarks. Please be advised that this call is being recorded at the Company's request.

to Officer call of like Elston, to now Financial Chief EyePoint would turn over the George I Pharmaceuticals.

George Elston

quarter discuss Thank for you, me Chief Pharmaceuticals' today to President Jay developments. Executive joining all results second EyePoint and us on is for recent and quarter today's conference With commentary review thank and we corporate open XXXX financial you Officer. discuss Duker, and Dr. financial call clinical trials will on and updates Phase with close second corporate begin EYP-XXXX, of with will will recent the XXXX your a results call our I questions. II then for Jay

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

of our XXXX. we time formal Before Act for success plans about harbor potential prospects. remarks clinical expectations, candidates, Litigation Private the lines, matters you we forward-looking that purposes Securities future of and make and remind our provisions regulatory and of projections, various I'll statements developments and and product today the safe constitute the financial our the our These will comments, products include under begin statements Reform

Any and statements with only. file Factors Actual SEC SEC on of in filings statements as future. those various Risk annual results discussed is our the with which may views of represent of may forward-looking indicated XX-K, differ most materially forward-looking a section on the that as those report the other from Form in the our today we make in result by these important including recent factors,

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

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

Dr. Jay Duker

as first-in-class thank to Good and those advance brighter technologies we of site. delivery for you, George. losing their for continued joining and a morning, us everyone, therapeutics future Thank risk at provide you success discuss our to

all, of I to like the EyePoint's thank for in for also EyePoint their entire like the and say name Board I'd collaboration, leadership and that my First like me. EyePoint. and I I'm would team of with Nancy tenure the CEO to honored Directors to at executive their partnership, confidence during thank would

to in bringing incredibly disease, risk dedicated physician mission of at a outcomes of losing patients innovative therapies retinal their to improving I'm As about sight. EyePoint's passionate

seven past pipeline the advance For years, patients. opportunity aim talented of I've products at to professionals with exciting the to work paradigms team of with of the EyePoint the transforming treatment had closely for exceptional our

this I'm execution goal. committed continued towards to

in to at we our pure to stepping stage YUTIQ, of CEO sale play our With completed recent juncture. into the incredibly transformation excited company, biopharmaceutical development With role a be have this EyePoint, important at delivery patients. therapies and the ocular I'm compelling and opportunities, strong bring sustained a clinical leader as pipeline we're systems, balance well-positioned ocular along grow drug best-in-class impactful multi-billion-dollar representing our product sheet, to a to with delivery to

that, upcoming of recent overview give now our and With I'll progress milestones. an review

from program, serious patients maintenance a for paradigm our treatment EYP-XXXX lead potentially Turning to diseases. shifting suffering eye

macular We for PAVIA X degeneration DAVIO oversubscribed diabetic are the retinopathy for NPDR. trial wet trials. two trial now fully The and enrolled clinical II non-proliferative AMD Phase in or or age-related wet

properties. erodible isoforms. Durasert technology. vorolanib, EYP-XXXX is therapy pan-VEGF chronic our with the a EYP-XXXX a diabetic formulation inhibitor the diseases, a tyrosin NPDR, kinase selective all receptor consists macular With AMD, edema. acting of Durasert VEGF As and to of brings VEGF that bio serious release a By sigma highly E, mediated new sustained as wet posterior reminder, such small blocker investigational treatment unique an of approach molecule blocking mechanistic as

to TKIs, profile receptor off-target for at molecule. the binding this reduced differentiated to clinically not efficacy TieX and relevant improved inhibit does vorolanib a features potentially and other safety Compared doses leading

potential the E antifibrotic possibility is the of through treatment dosing benefit reliably neuroprotection delivers months mechanism EYP-XXXX's nine of consistently steady EYP-XXXX the another zero effects. with Additionally, approximately action and for order vorolanib kinetic and eye for Durasert in technology.

apart photoreceptor effect ARVO we biologics. retinal model. a and that demonstrated acuity validated improved in potential annual unique mice effect in April, its it set the may with for and vorolanib treating neuroprotective in data that meeting thresholds highlighting retinal EYP-XXXX of ligand binding in new potential photoreceptor data active vorolanib's highlighted degeneration. of At preclinical the detachment presented significantly with action change Suggesting The diseases against reduced data preclinical severity degeneration visual contrast baseline vorolanib treated from existing compared drug placebo. vorolanib neuroprotective the against potential a benefits mechanism These preclinical the of in

would AMD, DME, clinical action of it mechanism an be provide vein such reflected NPDR, occlusion. treatment blinding wet this data, of as retinal chronic new the diseases Should in retinal and for these important

our pleased EYP-XXXX. trials II are of key We very with the two progress of Phase

in sustain In trial, subjects the current could majority of AMD or longer months wet the improvement wet patients single months treatment This six a States. on AMD X in anti-VEGFs, two dosed being EYP-XXXX. every compared to with DAVIO previously goal to EYP-XXXX the represent a XXX of is care significant of the are standard effect with investigated United treated a up to for average injection following which

can treatment losing visits is sustained of without and have wet are maintenance that at the molecule lifetime This delivery vorolanib, so patients visual for number therapy we anti-VEGFs, potentially using a provide following a flexibility tremendous with represents sacrificing frequent of to reduce practitioners to EYP-XXXX patients induction large the specialists treatment from to AMD. retina By aim for a their outcomes. burden sight who risk of

injection standard doses EYP-XXXX FDA-approved of two single approximately a previously All of in approximately or with Aflibercept control. versus intravitreal milligrams DAVIO X on-label an care office therapy, assigned the delivered three one randomly the treated to were physician's anti-VEGF similar current anti-VEGF patients of two in treatments. EYP-XXXX milligrams and with were to a trial

at we July, I X presented meetings X DAVIO Phase trial wet updates for Retina in baseline medical OIS DAVIO in Recently, Innovation and the Summit from At DAVIO mask, safety trials. II the provided interim, several we demographics Phase the patient and clinical AMD.

no there X events SAEs of enrolled As found SAEs adverse in safety XXXX, were a ocular systemic July XXX drug serious X, related summary drug trial. the mask or related or DAVIO the that in patients reported

X on average, reported and patients suggests have versus central better DAVIO demographics the cohort. Phase of patient II patients visual subfield XX at acuity that the trial. for in DAVIO starting letters analysis XX an BCVA Additionally, baseline baseline DAVIO in DAVIO letters than less was Mean X for the the thickness X Phase patients I

central microns X evaluation, for DAVIO patients subfield in OCT XXX mean trial. thickness in on DAVIO the was the microns versus I Phase XXX While

Additionally, at this in Durasert evaluating XX-month year's Specialists American EYP-XXXX's a we pharmacokinetic platform. meeting Retina drug from Society results study annual July, ocular delivery of presented through the

also nine to six screening, require anti-VEGF results, that for supplemental one that fluid a I analysis no We and patients any additional DAVIO up to I XX% year. up of EYP-XXXX the at Phase Phase did final XX-month the excess not had encore DAVIO injection for of which therapy not showed months, subgroup did over presented require an XX%

marks of clinical outside at of it AMD. encore Congress XX-month is European in because results the we DAVIO presentation significant, previously Phase time we In EYP-XXXX presentation June, an results trial United wet Society presented evaluating EYP-XXXX the Prague that XXXX The the presented and Ophthalmology clinical States. for of the I trial treated first

are December reading top-line excited of we this year. X trial's We forward results look in the out the progress, for DAVIO trial very by and to

saw This turn phase second pleased indication, evaluating Patients trial as assigned to injection. trial were doses is of three XX investigator group the approximately PAVIA significant in one interest sham that to randomly Similar II enrolled that succeeding DAVIO and we June, to enrollment PAVIA potential to severe received X the moderate of control Phase and treatment XX-patient we approximately our me clinical or let completed milligrams our a patient Now, controlled patients randomized to nine-month milligrams, target. EYP-XXXX for the trial, a In two trial the NPDR. EYP-XXXX NPDR. II during report two a enrollment or to were trial.

is trials the with single injection the EYP-XXXX in wet physician's office delivered AMD in a As intravitreal NPDR. for

which important is PDR. intravitreal As blood macula, vessels diabetic DME, visual injections diabetic of a there eye XXXX. It's treatment proliferative a third are a common NPDR diabetic eventually disease in impact Americans the and XX of over reminder, in that ultimately to growth, safe, swelling to is result called and over option for options. age is convenient or weakened, projected retinopathy, complications need to note time the vessel with very that or these NPDR maintains available XX period a which fewer vision macular abnormal a long for therapeutic remains Both one severe potentially than a NPDR, called and efficacious, adults that leading of the In blood is almost can patient's by affects currently edema, over proactively of great unmet loss. million

of complication. NPDR until burdensome their with no approved Due progresses to treatment their patients doctor short-acting course from apart of disease currently XX% the the received treatments. threatening eye site by nature observation Approximately of a to

potentially could vision trial of safeguard of longer the for time track Top-line quarter a second patient's PAVIA period for data II phase our and on remains between EYP-XXXX much treatments. XXXX.

we in EYP-XXXX also Looking plan II XXXX. trial a of DME and phase to initiate evaluating the quarter first ahead,

into extend YUTIQ of to runway royalties. us $XX.X sold creating for treatments potential we focus drug advancing all This debt, outstanding bank a sharpened our and and also to with phase sustained projected diseases. value eye trials. to Alimera serious our cash transformation sale XXXX Sciences The EyePoint's for pipeline addition of development transaction III for as SG&A, million prepare pure reduced May, in Importantly allowed in expanding future into our retire completed on delivery our company we play

the call team now review George? thank the quarter. I incredibly to to will financials. back to over the for EyePoint an entire George productive like would I turn

George Elston

Jay. you, Thank

a for three quarter. As issued the months in XXXX the focus the the for financial on included my press release June review ended high-level XX, were today morning, comments will results this

EyePoint cash $XX.X to receive we'll mentioned installments an received royalties. YUTIQ sold Jay $X.X quarterly franchise in to at in million a for and million we XXXX. addition future and $XX payment million closing May, Alimera additional upfront equal As in Sciences the

bank able to existing were debt pay improving significantly sheet. our we of from all Importantly, upfront proceeds the off transaction, balance this

XXXX, XXXX. Alimera the on terms of licensed the exclusively calendar received agreement, In Ocumension Taiwan, Macau, Alimera's years royalties to will we is Under China, the related receive to thresholds to through Kong, Southeast a net defined global U.S. rights for continue sales. sales Hong commencing low in above EyePoint mid-double-digit where addition, to YUTIQ Ocumension Asia, for royalty receive outside from its of Therapeutics and YUTIQ and YUTIQ will XXXX

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

over revenue the Consistent in from to CMS in decline to XX, the discontinuation reimbursement for with period. of along with of in XXXX to our year revenue exit YUTIQ, was YUTIQ Alimera franchise from the the franchise. $X.X Net sale sale for on collaborations period XXXX. The Earlier revenue due from effective activity and deferred January second totaled of which May, in through the increase June XXXX. $X.X a corresponding marketing X, the the to will quarter of million by recognition DEXYCU pass million, due commercial primarily the royalties of the The business. ended two-year recognized compared loss this be from resulted

million by million net XX, $XX.X spending the expenses for year period. $XX.X prior a lower the in on year totaled $X.X per million for period. versus EYP-XXXX million net ended driven prior higher $XX.X This trials second sales of increase June $X.XX by partially the Operating net quarter primarily XXXX, offset R&D was clinical million $X.XX $XX.X was and or share per or share Non-operating compared expense. loss loss expense to and totaled marketing

XXXX totaled to XX, investments at million in XX, June at XXXX. compared $XXX.X December million $XXX.X Cash

progress planned We enable in and XXXX. XXXX, on and capitalized our value are pleased the investments to quarter EyePoint's June our cash to advance we key product us equivalences, inflection XX, current at In expect and hand our pipeline points. fund and into to conclusion, second will well year-to-date, operations cash, the with

closing remarks. to turn the for Jay back I'll now call over

Dr. Jay Duker

Thank George. you,

for year multiple on As continue see been an catalysts. you excellent execute has thus EyePoint XXXX to far can as we clinical

to and DAVIO clinical trial creating Dosing the Phase potentially our partnered in second of a reading number year, DME advancing patient quarter including forward, programs. the data the quarter in of trial XXXX, clinical first II II of positioned from out data value achieve the stage Phase EYP-XXXX trial wholly-owned and Moving Phase our from December. top-line milestones, includes well first we are discovery in II clinical pipeline of and next that our in products top-line PAVIA both of X

of benefits blockers, We believe anti-VEGF treatment. game-changing the new technology any with profile. a anti-fibrotic nine consistently for patients a eye after to active action up providing and unique a delivery drug serious majority and EYP-XXXX retina, patients including months not positive from proven a ligand of A a vorolanib the is over beyond treating of for therapy mechanism to delivery neuroprotection treatment potentially suffering single to disease months diseases, approximately benefits retinal potential safety supplemental with six requiring

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

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

Operator

Instructions]. [Operator

line Our Cowen. Buren Tyler first the question from of comes TD of Van

line Your is open.

Tyler Van Buren

got Congrats morning. look couple you. forward over for a the good the year. lot next guys, questions all I've Hey to to There's progress. on a

mentioned acuity results had the the of that in X can discuss how visual DAVIO in the for fluid compares trial the in the DAVIO to no X the that those, weekend, coming presented has and subfield in, you So, for that that readthrough enrolled starting But central at were subgroup one for readthrough is first QX? thickness on the patients over you patients what baseline what excess of the course.

given safe does in guys not XXXX question is, you And pop-up the the safety what by the then, issues to trials experienced potential introduction? can clinical that during the second launch, harbor have upon early do issues same market ensure

Dr. Jay Duker

heavily more trial. In Tyler. on DAVIO patients. X pretty AMD a average, the population CST cross we treated take from thanks acuity X, DAVIO first the Appreciate had X.X year section prior. Again, they group I'll we and had believe, people. received visual X, to represents questions. the wet there. one DAVIO of a just On Well, injections of in of out remind

in so, XXX And drier were the DAVIO And DAVIO in were visual X X. acuities CSTs XXX. about aligned better versus than the

look Now, was back fluid, fluid. X, no three allowed if and subgroup which the had fluid. definition, excess CST microns, that by in cutoff analysis go some subgroup some X, we DAVIO you and at allows in Remember, XX DAVIO the

excess fluid So, XXX the no the CSTs group in about was microns.

DAVIO were severity disease X in X. acuities, So reflecting naturally the subgroup however, DAVIO cohort Visual in DAVIO than less the the the again, analysis, X. entire of even worse or

to read to broad was so think was to through, their DAVIO end make I the through, the DAVIO population. and say, population about DAVIO with than safe it's wet for As the X that dangerous X AMD but better X under read again, of 'XX statements say I control it's like

received in safety been people again, the has FDA it. the products a has are never The there good for of XX,XXX decades. significant Durasert few was very been course platform safety on retina estimate that The aware clean community the over news last that second everybody's while. record. Durasert safety mind, over We really question And of been signal in a around has four has approved is, the is any in we Remember, platform. have and

erodible actually E EYP-XXXX form we're has Durasert fewer Durasert or excipients. the that using The

should believe So, be we similar. safety the profile

an two it. Turning vorolanib in it did to agent received it XXX trials, oral have was while vorolanib, an approximately patients toxicity in systemic toxicity. ocular tested as no agent wet at as total AMD oral had And in

DAVIO DAVIO any reports X the or SAEs. in no of we far ocular seen and drug related no have had so And X, evidence trials,

of Turning what safe equivalent times could into we that a it the rabbit. rabbits a XX human, human ever in dose preclinical, we that preclinical in a on to have was data show put

point. dose not rabbit tolerated the at we've found of this So, maximally a in vorolanib

Looking six of a is up rabbit human into we've at and eye eye. the quarter rabbit inserts, injected to reported. a The eye a inserts of toxicity was size about no

So, we're the very comfortable EYP-XXXX. far, clinical with the preclinical talks and talks so with

events in lot do patients X,XXX course, Of got out. you to if you're a would about could or in X,XXX X,XXX occur of something before come like that talking that XX,XXX,

Operator

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

line open. Your is

Yatin Suneja

about tell Tyler of that first Can for terms just Thank study? you study? baseline then provided, the retreatment just maybe the was the III, like pivotal? on once on re-treatment the show what you you talk into coming you you. moved goal that them How Phase question. the maybe plan have the Maybe So and in like would average up what can in get in that's you be? to would pivotal patients, us Would these into the injections the label, following you

Dr. Jay Duker

Thanks, Yatin.

to question been will from injections been II That hold the has we but about number yet. show that for type of until the of or off talking trial. That's showing the data leading the data first publicly The Phase the about into hasn't collated it collected, top-line. we're patients ready

be is at it that accurate. this about seen data we're data point, that talking as until So, confirmed haven't and we a won't the company

first program. them. when a from want months them specialists Why every to what all, of the start to six That's ask our That of been you With get label most EYP-XXXX is and Well, very for poll retreatment. every goal. six consistent the retreatment, the respect we've retina want been answer months? that's we

about to a you that in have months? months if you flexibility. these that's programs well, Number why data needs different. the you been patient's of two, And last down a why, one re-treatment in drill drug. determinant you human, the six all anti-VEGF is number could it is really, the shown patient, isn't the can when nine a Every go for insert the a ask, really And would answer that patient

patients would third the every result, went This re-treatment. early I, a our of have as to we year a Phase retreat without So label studies last plan. But type the have doctors and completed. to in them was and tox And the year. a C to animals full with a FDA we been been that the as on like months flexibility the our is had out six as in show that's the meeting discussed re-injection safe

are plan And we II we optimistic dosing to our that Phase of pivotal FDA meeting end when agreeable be pivotal the the X YUTIQ to to plan throughout the trials, trials. have our do will so,

Yatin Suneja

you. Thank Okay.

Operator

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

line Your open. is

Jennifer Kim

of quarter my congrats Thanks taking your again, congrats great on for questions, Jay, on execution. and new another role.

of thoughts we prior question readout? the first question to that into following second just the we the data reasoning get then on up the we'll And terms DAVIO coming The baseline December granularity planned the X. the of just last readout, on expect about December my is patients Could on average injections etc.? Thanks. terms is should What December? any patient's of get in in of data rescues, what for in

Dr. Jay Duker

you, Thank Jennifer.

publicly a again, and It isn't been the charts something until not confident baseline but numbers that investigators. are within that First, state it's from necessarily want the data injections, to study, is you're collected, that of controlled historical correct. has this you

advantage don't the to believe data interim value about I us any or talk around injection So, numbers. there's for

don't it we really the to point. saw we say, that to on be X, it expect would at less X.X Suffice know this DAVIO we but than

talk prospective believe injections denominator at about that in into what the However, the the that, at And is actually is the important treatment it's leading vorolanib reduction when retrospective getting really study, not look here to arm Eylea that I the you're really will burden. you receive. the but injections

more arm month three or Eylea XXXX last after get injections. received when the visit, either all two that, Eylea sham, average, that they patients their six fact, months got into the best on that's down really And year. injections the for the because should, get study load, of drilling a then is a in least the following at and So, Multiple and that that have get could studies average because shown they may That's kind supplemented. us the in they six patients of also the comparator the real get under world. control

reduction about talk reduction top we treatment So, talk the retrospectively. that at when line, treatment also prospective burden against the but arm, first will Eylea will burden be we about

down a Eylea X.X X little smaller which per That's One X point, number last that injections six DAVIO to the again, a injections year. goes than bit. arm the showed. in and Three the DAVIO trial drilling

be do lower. in because that DAVIO we just if will lack lower will thereof arms, or with X even the in different, supplements the be as treatment well So percentages the be denominator against will

So, just note there. a

two. Finally, up this we safety, percentages study. the be data of data supplementary we reported another course, rate have once group working show the to show visual acuity, visual in and certainly which, or change eight That else? top-line. granularity time that we're by the in should anything data. supplement I'd pretty through exactly to And some data we for But and the I'm locked able takes in because will were sorry, early safety and Jennifer, of will complete not month point. acuity also, month expect already will we by the what up data, say December, to be patients to of month again, show safety who we arms OCT free six, we in, showed all confident the be at do

Jennifer Kim

thinking factor you're DR estimates. Thanks. DAVIO that OCT rates prevalence at all Actually, and that talks hear around that great. previous question viewing about than I'm of The wondering a opportunity? X. is beyond one also lot corner, these retina maybe that’s NPDR we data opportunity, conferences Does about the in how so increased right into when No, Home you're

Dr. Jay Duker

molecule the is once too the a and a because frequency safe, less, treatment opting blockers effective, the tolerable, and really were If of treatment the not in months great. and would report nine we that's that year, that it. Well, opt for part large patients the ligand every reason disease basically large is opportunity or for as doctors was and treatment much lot say view frequency it. this of patients they're the physicians We believe

is trials, warning go or OCT, system. exams. every under an of Home Again, Home who the necessarily you've you're eye XX% in not when clinical early you know diabetics We and problems. coming in But what are trial, two world, up patients OCT picking don't that's a in month motivated even any got don't need are clinical for in the real happens.

So, Home vascular be early be could would them diseases an the And at patient OCT of for think catch do earlier. retinal get be to disease if helpful warning diabetic to should probably for I the that again, the home, it all in general, very population these you treated.

Operator

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

is line open. Your

Colleen Kusy

of with and a your taking on thanks little Jay, response you for there Do AMD a enrollment? that for to and the patients a of spoke a driving therapy current response Great. the bit therapies. have to way to sense control we Congrats wet Good progress what's variable is of variability the question. morning. in current to

Dr. Jay Duker

Colleen that’s a question. great

gets population, the patients or after what's away, Remember, continue get and go better AMD fluid. have in how So, come would levels of away. but to the the respond goes of fast fluid all the Most it to wet injections, monthly never eye eyes an say to XX% in fluid driving anti-VEGFs the you answer injection. respond XX% wet anatomically, I up simple persistent VEGF of seen approximately, we meaning despite AMD who, worsening fluid an have time is all

there's again is drug, patient and point extend not a try a time don't every or monthly The you good is they injection get who treat but them, of to fluid. take news six that can one with weeks, weeks to patient and the I five you think many requires

or months, out got can't to go get levels. to You months another three drug because them four patient just to that expect they're and high-VEGF switch

blocking really all that's of turn back to level, know different Now, EYP-XXXX, action. going this isoforms receptor how we pan really because We're it to to don't of a is the at out, mechanism VEGF. yet intracellularly

So, of and there a similar may responders where be knowledge are good responders. there bad type

that I have the going that with just meaning worsening the way the back the that expect of of six-week trial, standard care, that had And failing drug. end eyes from despite injections that Phase standard of VEGF, were to in eyes. monthly of it could 'XX throughout of didn't we believe appear we to the did We any or saw much the fluid. these benefit drug It of offer in eyes bulk of data I we our that But a every rest population those EYP-XXXX that and our do the appear if efficacy, had safety, rest tolerability AMD studies. phase from hold the care

Colleen Kusy

And approached getting of for the rescue II, light to how in you visual balancing rescue acuity phase the just patients free? and speak then you can criteria fluid

Dr. Jay Duker

Sure.

And injection. non-mandated of injection, of So, shows rescue activity, again, in categories people the disease activity. I eye which There's know, and there's field day gets that criteria means this. criteria mandated because day in rescue anyway then by disease I a protocol, a you there's patient standard the the that know as means two interesting lot visit, there's non-mandated know, really. Disease is for also for they're that think a the that no and activity the who

a that. quote-unquote based not they're on visit to rescued. different interval being of shifted being just They're So,

definitions, kind definitions, within two parameters. So, study those different of there has are different and every

from what criteria III. far Phase should I'm II be. companies to criteria As And as aware, companies change the the rescue the on FDA actually never rescue you direction I given Phase to has see to Phase

change in trial control just the that's achieve acuity and pivotal like the would us, Eylea primary is that in statements general to visual non-inferiority recall the endpoint striving are achieve a So, to we against for that arm.

effort So, to about. intact, that's I. try the letters ultimately XX for that's really the to try visual was in five in we keep it acuity bracket, to standard lower elected the the It visual what care Phase to to And an again, patients in letters. II which Phase supplement in acuity to

Yes, there's fluid, ultimately they and fluid, picture OCT about you how seeing. cares retina can there's but show of a patient is not what or say, a specialist oh care their are about, look, what the they

So, a biomarker, for perfect but a OCT visual are and not fluid acuity. biomarker

the visual So, need that that's non-inferiority we in to achieve goal change ultimately acuity.

Colleen Kusy

Great III your the program? non-inferiority for us just can what last and Phase is are that you sense. plan design? on makes us, funding thoughts the what just current one And of that go then your Would from remind thinking you

Dr. Jay Duker

the first go part second part first but, with Well, easy, part's question, broad a is the first. the I'll

our II a expectations. plan we time and the type III. designed to the Remember us to gave look excellent go was as very the with So, FDA meeting at this Phase guidance C FDA to Phase the have what similar to the over did was

look to talked is if one obvious Phase EYP-XXXX the at them about We So, months II two, on of going which I of there And a trial. the be protocol, plan already, we in trial. pivotal re-injection our pivotal protocol, six are DAVIO two-year you X re-injection. in think, doing the changes every

approximately was The at the at weeks. pivotal efficacy XX in for trials is readout the difference The efficacy second DAVIO year. be efficacy eight The readout will X months, readout. one

science things X other things, look X dosing, similar. and very and will III on criteria, us will Phase the the like DAVIO results structure the of of study, those inclusion-exclusion Now, we ultimately see all but DAVIO DAVIO until the inform X, undecided from end of that's

say from well-funded we're a Now, perspective, just very right funding I've now.

can into ask a sheet balance helped kind and all we maybe pivotals. discussing of II boutique cash to The Phase really sale of us. have options We've are I'll that. There XXXX, the George we looks more are our multiple to fund trials. Our great. fund little color on so, And got give

George Elston

Hi, Collen good morning.

I talked interest, it do and think we publicly. be to openly are, Phase defined. me ultimate the strategic what We're, know at pardon look we've as the while Phase transactions this about really we those never talked going We've and have cost is that of [ph]. III, you II some

for be partner, a the data. includes a in I that We to which data to today, by more equity but what going sense. clarity good on are Phase lot think mechanisms us a the price, think going other potential really But raises for IIIs, we're total to fund The II I structures evaluating Phase III of and in will here sitting Phase position may and to guided trajectory cost date is range on a give the the the we're December. us make bringing be ultimately in

Colleen Kusy

taking thank our you for question, Great again. you thank

George Elston

you. Thank

Operator

you. Thank

Daniel comes Our of of the next from question line Catalin Chardan.

open. is line Your

Daniel Catalin

on Thank a question. Congrats your you for taking progress.

EYP-XXXX a Thank provide what Just could is to anti-VEGFs approved patients in than also strategy with wanted PAVIA? other benefit that for showing you. other ask, your

Dr. Jay Duker

pivotal for you Thank The time, be can on-label for FDA least at group question. has present the control At LUCENTIS or a the been EYLEA. trial. in AMD wet guidance, on-label either

at the DME wet for for by So, guidance our It's that case we're control currently, different which and for when our be standard EYLEA treated DME pivotal. is different. limited AMD the wet in then choices But AMD certainly wet who as point previously use control the to treating start care arm. we may patients different, AMD DME of label that on the possible arm the may plan in may pivotals, have be be

Daniel Catalin

you. Thank

Operator

please. moment, One you. Thank

from comes open. Our Kim next Kim Trading. line Sean line Sean Jones your question Again, the of of is

Sean Kim

could treatment on following deviation the and and standard taking comment and control. trial with II whether I looking Hi, oplibercept I both are X, noninferiority the us Maybe question XXXX you relating a statistics, remind also to can in what is thank for the to Phase guess for the you specifically you XXXX first variability for variability. and powered in DAVIO your is, question. statistically the my X the Phase observed expectations for X Thank II DAVIO you. regarding the changes acuity Phase DAVIO ahead visual as aflibercept, trial,

Dr. Jay Duker

Sean. questions. Thanks, Great

the respect end the statistics powered II, First could read of X that of Phase variability was I'm much variability, again, of study EYP-XXXX, not to through acuity but statistics in that X. There the DAVIO absolute there's that. in of sure confidence. variability there's The the would It a, to is certainly have but the that descriptive The to study non-inferior. and different around to probably do small is only. show no remember are well Phase necessarily DAVIO interval, not that, four visual was doses too confidence all, to II, with be this

Phase similar we out finally, we had you go, port diagnosed The with the treatment if that previous letters, study or naive nine limited population patients expectations aware do but can usually deviation, delivery is deviation it's look to maintenance were wet for wet a deviation by standard studies. variable. pretty of that what's all standard for that who around trials, for less. system trial, standard X.X study there of for was of the are And at which looked patients only months letters. And AMD III enrollment perhaps a at AMD It's XX

study closer diagnosis than our guessing, and XX. wet allowed, to time AMD would of the any I X.X standard would if the guess essentially be I Our were that of deviation

would sense. that make I think

do would However, answer questions? That's that II trial. one a reasons classic refer many that your Did we know. the to I what of we kind don't chose of as to Phase

Sean Kim

Yes, another Thank And very squeeze separate on helpful. question. if I very it's a in much. question, could you

relating new you. to would will needle as for So, approval, combination Thank injector XXXX potential confirm the developing, may option could or the I it's intravitreal a guess you packaged clinicians allow and for drug-device to use standard that an proprietary you apparatus? be you're

Dr. Jay Duker

development program, while from the the drug-device And No, its the been I can the requires around confirm be start aware changed that. that since FDA of this of that were we EMA combination. will that. We've the the a program into of guidance

that injector prepackaged. sterilized, Phase out, package, in tab are ahead injectors no, II These The current inserts be goes of opens and have So, drug-device preloaded, load for and a to They the sterile it's a the the trials. of doctors to And then and their and wouldn't we into or currently preparing up using we're combo. just injects. intend true we've own wire any been takes a the syringe physician kind hypodermic. this

the be something and from that's pre-sterilized, make them to plan deviate no would to going be self-contained and to doctors be safely completely there inserts. So, for really for that. to This deliver it easy sterily is the preloaded, going to

Sean Kim

very Okay, you thank much.

Operator

moment, one you, please. Thank

question comes Company. & from Laidlaw next of Jen I-Eh Our of line the

is line open. Your

I-Eh Jen

the morning is and question the pivotal thanks seeking the Good in taking study. Jay, for label seeking, question. first of of terms potential a label that,

months. to you Would to You treated? also you you patient, all But seek cover seeking? the need So, label potentially six mentioned for can curious, treated, be in a earlier just patients for that be rescued example. case re-treated months, be in of the being that are need few five very that or patients

Dr. Jay Duker

see there, timeframe. So, planning I-Eh six see months of at results really pushing And time, could study results. then or getting would in pivotal the a our depends seven, month after XXXX in, in be that trials. present in pivotal the we're we shorter to a trials on If it not value be positive on supplements the month post-approval not I of every may goes part lot we're that. at that there If five

than be something it's it shorter looking testing But point, will think don't I months. I at we'll six this at. be that believe clearly

and one, approximately over prior have patients into six of where view every other was many the but the weeks four Phase treated with whole did our those I get stable majority here to is of and third the again been OCT or require to another supplement month the going those in this of patients didn't I a up study. of weeks in treat six, to There trial of months six any supplement. XX% the who could Phase patients and go vision stable Part maintain, the only the about got

might And from a six being three even drug's and So, extend, shifted every being further approved and they blocker further ligand lot months. and four it out a four certainly there's patients treated blockers, push or that, doctors gone alternating why months. consider ligand to treat an a, by the Albeit reasons now could patient doing to treated weeks you've every be as the three by with remember of a, XXXX. with

visit doctors miss if to or that patient release in eight if they that the misses insert for safe, that tolerable and in I working think patient or And would sustained appreciate visits. background nine months a is they effective, a know up sick, gets

label the So again, something to what it's sooner than now, original months, retina based community right not planning back six but consider data on the pushing question, the will based and certainly wants. it on on we the

I-Eh Jen

years mentioned what be And behind just the incomes I'm completed? just curious, maybe that you housekeeping that your YUTIQ period. be that believe that's given one very great Okay reasoning the sales is question helpful. I sale two revenue for over might George. will already amortized

George Elston

upfront. with for There's tied nature lot, accounting supply the of the components. upon that, Yes. of your those of also agreement together. license to the the a the based and It's the really of IP and are accounting-driven, agreement sale YUTIQ Alimera. continue and million will Thank really that's of question. is and rules, the a XX.X we the Part license and have Alimera to supply the interpretation And them. One because asset two sale to of you, ultimate

that predicted on so based two-year $XX.X volume. And total a of recognized million will period, be over

it roughly think two it about those quarterly be would So, years. your modeling even perspective, if you from over

accounting will We've million [ph]. the upfront. $XX up. non-cash revenue, it's never show and already of the Again, got treatment that It's just

shows as It's As that up you royalty financials not see today, collaboration line. product the a savings. and in a

I-Eh Jen

look and that, And sales? like enhances something more product

Dr. Jay Duker

occur but commercial partner the it's from For a very No, the sales P&L different to China, not accounting both our mentioned, on it's very, true following our but Alimera in treatment. and line now. we're sales,

I-Eh Jen

Okay, great. Its squeeze Maybe more for helpful. Jay. very just here question one

of NPDR, moment. than XX% the receiving is treatment at In terms it not of patients that known more

is that patient data, if out against there sort can XXXX, to drug the turned of encourage infrequent the paradigm? be besides the treatment of the and physician to that question use other of current dosing, the is robust. terms factors The backdrop in So,

Dr. Jay Duker

back what to better ligand really efficacy our great the what principle, approved the way because a safety could the so if it's therapies. the far, if safety? the And I Again, large that efficacy of to seen vorolanib go the true. so, as be Yes, staccato against it's currently kinetics than of about this, that zero-order good release, first and look to even is it efficacy was think imagine is you a continues of with molecule has the the blocker, but possible advantageous injection and

market. around flipping physicians you're patients two our in and to current really safe a that Well get any saying, if market blockers, and are part tolerable, think things of and if than well, but the efficacy drive opting less? even essentially given safe we'll I think that significant we're degree those market grow what your we'll and coupled ligand they that large if is still less the for would it I have, not direction, but is our efficacy

I-Eh Jen

December's thanks, looking forward Okay, and again a congrats and in great. data. positive very That’s helpful,

Dr. Jay Duker

you. Thank

Operator

Our Wainwright. next of H.C. line of the comes from Gollakota Chaitanya question

Your is open. line

Chaitanya Gollakota

This on is [indiscernible]. behalf Chait of

questions, AMD? my so I'll landscape wet quick just of one. you've treatment Thank one specifically in the with that most answered noticed the major You've Any leave maintenance for of competitive you you. developments

Dr. Jay Duker

Well, thank think are there would I for then no, don't and any that question say you it recently, I developments.

in same Against that drug extended order as EYP-XXXX last refer put doing means sustained the release, duration. the it with sustained or release got what you've more meaning first-order we sustained longer. think, but method to The when is I'd be release got in would a you to I as true or release inserts that kinetics, you've duration I and putting true the continues would are therapy. a that about that device to drug, talk you're extended that category. gene what of EYP-XXXX, a have like in

competitors, conjunction refer or it. population for a with and at now. two in might the be have the high-dose desires to be But or needs we're can consider we And Those it we looking if because obviously, launched to Obviously, patient don't that maintenance doctor hasn't forizumab high-dose those while really a EYLEA. used them been EYLEA again, around yet.

we iterations previous That's value. longer, need out, you last them don't the than one unlike came when of anymore. new one, where the not anti-VEGFs we're was, better the promise last So, our the

which or result Our out is six and wet injection, value AMD is we acuity. which provide anti-fibrosis, the single population may provide half do neuroprotection longer they can we with can't, at take, months visual in the data a possibly holds and something possibly believe least if better

been answer landscape to the don't the simple back in is quarter. think in there's the significant question question, competitive the to any So last I changes your

Operator

does in time. This And at program. participating and I'm your conclude showing this further Ladies today's thank in gentlemen, questions conference. for queue the no you

have disconnect. great now may Everyone You a day.

Dr. Jay Duker

Thanks, everybody.

EyePoint Pharmaceuticals (EYPT) 2 Aug 232023 Q2 Earnings call transcript