EYPT - Earnings call transcript Q1 2022 | EyePoint Pharmaceuticals, Inc.

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Operator

Good morning. My name is Josh and I will be your conference operator today. At this time, I would like to welcome everyone to the EyePoint Pharmaceuticals First Quarter 2022 Financial Results and Recent Corporate Development's 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

first our to Thank discuss all financial you, With will EyePoint me comment quarter XXXX call President Scott Nancy corporate for we'll operational you commercial financial Pharmaceuticals' discuss our and www.eyepointpharma.com. for release well joining we will us I today close press and Josh Relations and Earlier on the today's the development. and results momentary on open recent first of quarter website, release QX XXXX thank Lurker, results development. is conference Officer; copy Jones, be review Nancy on results then Officer. and with the a questions. developments commercial Chief of found Duker Dr. the call corporate can on pipeline morning, will tab Duker, Dr. Investor Operating Chief and detailing your Jay Executive as EYP-XXXX, activities. Commercial Chief on Officer; up then Scott as the updates. corporate recent A this and financial issued the for a begin will

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

statements do change. forward-looking we these representing to future, to of Chief statements if While any elect Nancy Lurker, some our so obligation subsequent call we Pharmaceuticals. as these point you the to now even disclaim specifically as today. at date should turn on I'll Executive views not our any views update in Therefore, EyePoint rely may Officer over and President forward-looking of to the

Nancy Lurker

I'm getting Thank you, George voice, still hoarse cold. over a and apologies my for

joining XXXX. to morning I and want very the first us in good do you a quarter thank solid So, of EyePoint for to progress discuss made

shareholders, has Our had company XXXX the EYP-XXXX should our trials a create maintained for team long-term to to particularly momentum value and now for well-positioned clinical into be subsequent out report continues positively. we and positive XXXX

two just strategic We focused in our X the In becoming goal validating delivery. and clinical refinancing additional Betta corporate of Phase are keenly to EYP-XXXX, the agreement announced, lead leader of while trial simultaneously Pharmaceuticals. quarter, program, ocular execute presented first our with advancing ongoing pipeline enhanced for debt, results EyePoint our on our our initiatives; drug

AMD. our pleased EYP-XXXX far. lead I'm my the in wet incredibly patients improving bringing Prior our hires pipeline also States XXXX in around I'd call mission and trial long-term products turning and disorders with of in successful our the to like overarching growth consistent leadership eye United a for the to position serious encompasses over We company the DAVIO world. the colleagues, with our execution asset, of so clinical that important Phase team's made the patients of innovative that to of lives few our highlight X achievements to for

treatment of provides devastating potentially you the other A market, consistent vorolanib month the months, between for disorder, with combination with patients. using visits significantly potentially reducing vorolanib, AMD-related may AMD BioErodible and vorolanib an wet anti-VEGF of and physicians. on initial effective trial mechanism patients results six no up EYP-XXXX, of with provide a many for zero-order medications burden of clinical accounting a ability every provides and of Phase EYP-XXXX or patients this small patients acuity inhibitor, eye believe are blindness. that that wet approved But to interim DAVIO the to We potential Currently, treatment for of and of a eye anatomy. sustain transform action delivery to Under longer patients treat-to-maintain of challenge proprietary injection. on eye can Durasert, a treated of which while with six serious remains months, and six the benefit an drug induction kinase a burdensome the visual majority treatment our potential paradigm substantial maintained to macular approximately wet delivery majority to potential AMD EYP-XXXX to be FDA with able X potentially benefits. despite after As be injections supplemental release every physician know and up kinetics number AMD. drug. while month new the many based a is anti-VEGF paradigm, with office tyrosine EYP-XXXX safe and up of a adherence wet TKI maintaining all molecule months, traditional duration most therapy XX% technology, our ongoing stable treatment currently for has AMD stable an patients is period the for

the eight look forward ASRS well as July XX-month six the ongoing in year. of no DAVIO As the which X safety at positive in DAVIO X we showed Jay with Phase pleased to significant detail data be trial follow-up later continue will as with data Phase efficacy promising data results, far. to in so call, We inflammation, announcing months discuss now this our and at more

like wet work entire third as quarter Phase XXXX. for ahead, the trial to EYP-XXXX expect year initiate progress. of second Looking in I'd in we the focused the bringing And XXXX. results months six our as the to their interim we half to updates exciting for anticipate tireless AMD X clinical innovative technology of team thank many sharing on this forward EYP-XXXX's quickly look EyePoint additional to we possible this patients and as on in

for Phase for innovative to expand clinical of diabetic second with North America. addition advancing on U.S., our In study the additional retinopathy, are for non-proliferative NPDR outside the focus half or of of preparing in the X we indications partnering EYP-XXXX of treatment Phase year. development trial EYP-XXXX in to with consider of to X options AMD, wet a our EYP-XXXX beginning this Along this we to continue

China entered of agreement we This beta and develop selected Betta with as quarter, our and a Betta Pharmaceuticals. of with we EYP-XXXX EYP-XXXX. other was commercialized critical to agreement of This in Asian XXXX secured component extension contemplated our vorolanib, part current territories into an already partnership

In America addition, additional we vorolanib we continuing North ophthalmology, local look forward our of We time. expanded opportunities of look the also all work DME. our to to to delivery for outside including at with appropriate partnering rights of Betta and

along This our customer strategy strong franchise revenues, of quarter an breakeven business commercial quarter year, first products, to for million to a strong support net had both last to from this increase $X start XXXX XX% first strong a with as product our with and Regarding demand DEXYCU. year. commercial in we achieve the of YUTIQ status

These has of wanted updated eye. segment changes share a drug complete communicated combination significant the we the Additionally, potential trial sustained resulting to YUTIQ. cost. plan of on delivery, YUTIQ anticipated device increase recently now EyePoint products, update Phase posterior beyond XX our as in FDA the the six post-approval The to an an was in originally X requirements YUTIQ, the in [ph], additional months clinical regulatory ophthalmic regulatory trial for require such supplement, of what program's the for and

communities given YUTIQ its decision to that this and financial with which And trial As a for we've until committed decision safety the community to reassess XX can driven path patient Synchronicity about posterior learn this still eye is disorder study, YUTIQ segment first Phase and believe We a X enrollment we only to our CALM forward. if on like would made result, the in emphasize considerations and through for XXX determine series I there's Registry by pause and We months only. to the serving you update add open study patient resources and efficacy continue Study, important two-year uncontrolled, potential improve to development. our ongoing I'd uveitis. in the also on posterior clinical pipeline to outcomes we studies our clinical an uveitis registry which Despite is XXX the recognize and as the must the is remain that posterior label, this track uveitis. we more XXX. evaluate the to record that YUTIQ YUTIQ Study, YUTIQ and YUTIQ our designed safety organization, we the scientific to like patient to prospective, come. to plan of implant focus EYP-XXXX take for investments endometrial a segment the approach these disciplined proven utility follow-up of this a

from resulting of we cash on provided health we on remain with Valley $X.X company in refinancing interest and improvement, financial which included the our annual As EyePoint's interest later well-capitalized focused a pipeline, you'll on, million approximately with QX rates. runway. and George hear rate This significant Silicon remain debt a execute Bank to in

time appointments financial Chief all her and to evolution. thrilled EyePoint in Ms. operational, board across the Regulatory years first more of announce him conditions like look forward with global experience building Chief Lefebvre Officer. Officer. as Isabella growing exciting very Strategy two clinical, team than we veterans. Corporate I'd He to we regulatory of and on drug Pine Development as brings development, Michael for during on development ophthalmic out EyePoint to in pleased to leadership we experience of brings Pharmaceuticals, matters Finally, strategy FDA-related company's of team C. XX Recently, to were Earlier receiving the quarter, years have and success XX over business especially companies and in this we guidance important to-date. also Lefebvre strategies. phases new EyePoint appointment global year, this the made talented affairs appointed our industry and thank regulatory the in are

can deliver over Duker, our of serious the EYP-XXXX patients Jay? as for to provide near-term program, look now advanced drug so delivery, other improved to and a turn with Jay ocular I'll on that ultimately, as catalysts forward lead future our eye we we update initiatives. Dr. on future Officer an ocular better executing Operating the treatment multiple living disorders. pipelines call Chief As create to clinical we well sustained

Jay Duker

and morning, Nancy Thank everyone. good you,

pipeline. our an poised clinical our advance as catalysts on Before is I this year time is begin, I multiple team want execute to exciting as this reiterate what to we

maintenance earlier, a the macular Nancy with approach, anti-VEGFs. of AMD are program Phase trial for investigational unmet following DAVIO therapeutic being delivery sustained-release X as As an need we degeneration, we anti-VEGF, quite lead a of stated largest of wet landscape clinical an is pleased refer induction treat-to-maintain. our treatment therapy our with longevity pipeline results age-related EYP-XXXX, The therapy to action studied the wet as in which for

Our after retina efficacy, differentiated to controlled The longer to and or the give a injection anti-VEGF the eight AMD goal that confidence data profile up us tolerability allowing drug. increased their for majority months EYP-XXXX, months of positive patients' an AMD. wet of safety visits treatment may reduce results is and and through of EYP-XXXX efficacy flexibility safety, intravitreal to in of sustain a practitioners interval have safely the wet single patients specialist delivery and to sustained number six recent

of used its is paradigm system. technology kinase EYP-XXXX's efficacy are products molecule zero-order in has molecules EYP-XXXX, Before a different coined of thousands track the sustained-release and alternatives U.S. the the kinetics burdensome to EYP-XXXX VEGF so administered on and These consistent vorolanib trial, formulation the its have medication blocking the coupled I'd delivery receptors, zero-order anti-VEGFs confidence with drug touch Durasert of on proven a This safely to treat-to-maintain. FDA in an the non-erodible the could this safety, approach of current delivery has mechanism This formulation, VEGF. we and record tyrosine Durasert differentiation the use data, best-in-class BioErodible of far Durasert Durasert VEGF we we all with the In trap [ph] of anti-VEGF kinetics market vorolanib, technology results drug our landscape. differentiated beneficial safety for formulation review isoforms burst initial Durasert and with true molecules much well technology our that I delivery. as BioErodible after from with delivery bolster retinal the just with allows as drug of antibody change like BioErodible DAVIO BioErodible to of approved today. been sustained-release the seen patients Durasert tolerability, a four potentially treatment inhibitor. across bind action which the binds small have described differentiated combines to in from less PDGF. fragmented medication.

Turning Phase All across XX trial -- supplementation enrolled study no patients X is a previously the with now a dose and to employed. that the during standard-of-care reinjection for DAVIO was anti-VEGF DAVIO dose enrolled performed criteria cohorts. with our study. anti-VEGF patients treated with supplemental standard-of-care, typical therapy, escalation four study was drug were open-label

in efficacy safety month at in We're quite far. interim trial of of six have so October we readout Angiogenesis pleased observed Meeting. DAVIO the data with results we Virtual XXXX and Following months positive year, last February the a reported eight interim data the positive

seen patients in months to and we've over to XX% with XX% burden anti-VEGF for at at and nine treatment XX% as free efficacy supplemental months. up months XX% patients, well six Importantly, durability and impressive significant eight months, reduction six of as up

visual and microns. measured as central ETDRS in Additionally, central data optical change of coherence by letters three thickness thickness we eight-month subfield corrected observed subfield updated tomography acuity with acuity XX minus stable of best and showing plus visual the change

of retinal [ph]. reported. highlighted dose no the no serious no occurrences any cases with the anterior and segment no addition posterior migration ocular systemic drug-related no adverse of was into no In events endophthalmitis, implant data detachment, toxicities, ocular chamber or eight-month safety inflammation positive limiting SAEs Furthermore,

change to two treated As XXXX. one thickness QX milligrams of is Phase enroll subfield by to wet a milligrams, AMD previously visual assigned Approximately and OCT, best Nancy three patients, XXX measured mentioned, as randomized supplementation, doses control. X EYP-XXXX initiate aflibercept we or three in two in planned The corrected doses endpoints -- acuity, Phase changed in to of of efficacy EYP-XXXX. or X are controlled The randomly to wet for study AMD expected time of one central trial safety.

six-month in half anticipate of for second X this ahead, data Looking we sharing Phase the XXXX. trial interim

the we plan paradigm this a the in retinal including potential half EYP-XXXX of are We treatment trial disorders, other in non-proliferative retinopathy, diabetic edema, eye and also X vein several working retinopathy. occlusion. EYP-XXXX macular explore to change and diabetic severe Phase In of initiate second diabetic of year, to

disease addition, Diabetic the employing DME. now diabetic threatening X expect In for of will retinopathy. we of sight our Phase most third be indication trial edema is EYP-XXXX in macular common serious ocular complication the

to X Phase of this XXXX. trial initiate in expect We QX

indications over update. to will pipeline Officer updates turn the growing rapidly advances. provide year our Chief throughout Jones, on We Scott these call will the additional continue clinical to now commercial the I as for Commercial Scott?

Scott Jones

from increase quarter Thank for with a of product Jay. strong an record net XX% of revenue, last year. to excited our of first million the $X business you, We're commercial quarter

U.S. $X.X million units DEXYCU sales responsibilities and manufacturing, for QX for to look QX whose to XXXX. from Xst, responsibility markets. respectively. ImprimisRx Customer revenue compared been sales activity of and has for continued that for recognition, EyePoint partner XX,XXX presence uveitis of DEXYCU as retina franchise. treatment expansion XX,XXX product approximately QX from revenue of units collaboration YUTIQ Customer ImprimisRx, demand of $X.X experience posterior strong saw all for the retains for XXXX. YUTIQ in and was assumed community and demand commercial was Customer the alliance the demand ongoing for forward marketing an growth procedural commercial approved growth efforts Customer into distribution patients. net million to DEXYCU DEXYCU units we our preferred for a units, XXX XXX from approximately January due strong YUTIQ NDA, segment and [ph] for our XXXX. partner, and needle demand with DEXYCU provides remains YUTIQ and strong of and full DEXYCU and respectively for siliconized X% that physicians our Our approximately came and

important demand to patients. first YUTIQ for historically, Although with due usually to resets demand down quarter insurance it's these that note XXXX, QX was deductible for turned numbers consistent

of and pleased teams. businesses We the by commercial of made with incredibly our our the are commercial progress performance we've

revenues and now to and to a demand the the quarters both to look delivery patients I'd to provide visits fewer that mission you -- financials, for come. each on to requires doctors. the Our across attribute system forward all continue office, provide to doctor's updating is to the turn that proposition sustained call like George? unique, We George value over review product's platforms to a in for key

George Elston

Thank Scott. you,

CRG for new results X%, an To for and were improved press amount we facilities to with loan XXXX focus estimated million today XXst, included a a blended $XX this The our issued aggregate quarter. in financial first Valley loan the for level entered Silicon provides to and in existing secured approximately agreement $X.X on in months focus new our of the review will Bank the a savings. loan terms. the As credit quarter, comments March interest Valley balance in ended release begin, with rate with agreement million my facility Bank reduces three of high annualized the the economic into morning, continued interest credit XX.X% resulting from rate and the replace Silicon senior sheet

quarter $XX.X in an net the revenue quarter totaled million XXXX net product versus including driven XXXX. of the organization, increase first clinical $X.X totaled trial stock-based million million primarily XXst, personnel prior XXst, for $X.X Non-operating the in first March revenue million costs first $X.X Net million million the $XX.X and and was includes the ended XXXX. $X.X collaborations including million $X.XX XXst, period XX%. revenue quarter period. across for March by ended EYP-XXXX at XXst, investment net XXst, to royalties $X expenses for Operating for $X.X March net total ended $XXX.X an for in March comp. $XX the compared $XX.X expense the the XXXX, compared $X.X the corresponding in R&D ended year the to compared period, quarter spending, ended For This first in March million million, quarter of to or totaled in quarter share compared first from million, revenue loss March XXst, million XXst, product at increase year XXXX of per XXXX for XXXX. compared $XXX.X share was prior investments of loss totaled $X.XX a million net Cash XXXX December and or million to per non-cash and

on to expect are EyePoint's at well-capitalized to We product operator progress current and this first net points. with quarter fund over XXXX. of us our the turn planned much value advance Thank and questions. XXXX all we you hand now the March second into and our expected half inflows will and sales for from operations the in enable to investments XXst, and are call In cash inflection to XXXX product cash pleased conclusion, will morning the very pipeline of listening the key I for our

Operator

you. Georgi Yordanov comes from first Instructions] Thank Cowen. Our question [Operator with

proceed You with your question. may

Georgi Yordanov

taking progress. on you and Hi, much all questions so team, thank congratulations our for the

trial? that main in what most secondly, related you of that, get you but the helped you to what commercial successful from then chances like And be represent? maximize label? think few a has XXXX a of patients patient on appreciating you've better to percentage full what of efficacy seen the Who while optimal you given end, on far optimal ensuring would would we've to patient opportunity So, patients now the maybe design the you these fact And most this that have data I the product trial the your that do to is for could do risks data, number the XXXX? just and a population the success, be refine allude maintenance durability guess still for to our DAVIO registrational so DAVIO, that as see demonstrated that

Nancy Lurker

a Wow, that's quite list. quite a

George Elston

morning Good Georgi.

Georgi Yordanov

Good morning.

Nancy Lurker

to overview, and the if see answer triage team going can then I to me here. an I'm it Let out

we I the it with how your and data approach, exact refines say and some -- nine out on pleased seeing. really really of months course, long So, better to just And them. remain it overall see missed mean, we're reiterate your our of of what good this in, reported we we safety if definitely because which as come And is continue would continues questions, sustainability treatments. to months working. eight rescue we're on I efficacy. just on, informs we've

as to patients important we're dependent not they as is results, the on majority to of be offices, a able that we're continue elaborate not in have because EYP-XXXX. to six-month very majority to just we it's all know, long-acting just patients. to we a which this injected, the as doctors' believe, we're to burden. Now, designed want eyes anti-VEGF, problem as patients want to patients given fact approach get their still be need to coming and to durable X all is effective are here real particularly treatment, and keep really a to treated of understand taking, this current going they're a replace time safe. we capture Phase that obviously bit that keep on a treat-to-maintain And with I can The

to your patient. goal able the is anti-VEGF, patients then with possible, the So, eye as get can as in cleared an and put up and you go induce maintain be to ahead that first EYP-XXXX,

up So, we so can months. six the to some be get And fluids, supplement needed for to you hope, therapy, can't for may they patients with just of resistant majority as or existing then all particularly patients, a rid anti-VEGF therapies. treat-to-maintain who

AI. to action at mechanisms mechanisms everything know be we on different benefit yet caveats, action to put of two is of is on want there So, the we that I having different often could a have again, and board, -- work two because don't

So, we think patients. there's a of lot benefits for

we new a launched up commercial And and to a it development. to headed begin going what bit. opportunity for opportunity Scott fully a is by let paradigm. is need him commercial We more appropriately commercial Scott, develop have We and to task understand his because group comment to more group do continue just to I'm early that the a treatment just team's new to

So, -- Dr. then back moment. a now you Scott the of trials to commercial on some regulatory we'll going actually, I'm Duker need to I'm ask jay to comment, current just to get and change and the mindset. opportunity. in then the

Jay Duker

the thanks, Georgi think Yes, covered this on one the well. on add treatment? more extrapolate would strictly probably from answer thoughts at that of you And results. DAVIO, And the way a what percentage the I based things I patients AMD. asked I XX market DAVIO Nancy. is wet benefit from least you've that based just few of be would would wet AMD would patients XX%

Now reduced was what cut a enrollment. that to I patients it either if who they require anti-VEGF, enrolled they XX% mean though a or didn't prior about benefit very was of in to there did at -- the any clear compared trial, rate supplemental supplemental by is the anti-VEGF, to require

than very no of any a is majority XX, think Phase of safety at speculate X that we of in or major benefit issues. risks percentage benefit doing be AMD that's we Now, to AMD benefit efficacy to what risks and be enrolled we're really spectrum broader safety how patients That's broad why patients, a of a major that. DAVIO in more patients. the in the high trial But speculation. -- might level, what with we trial not I that a wet we're see than -- The can enrolled population is had greater in spectrum what we again, optimistic equals N in a in going the news good of will that a DAVIO,

a that's Durasert up tens the far small confident experience number number. both studies, humans X probably to a find the dose in for safety problem. thousands stems in and able MTD of preclinical confidence from didn't our would the that so vorolanib, course, And to that I N we either. We're animals not of say an bubble patients, in we equals the that think And will say in a of patients. I from been preclinical thing safety one. tolerated XX be with Phase be Of a haven't maximally to have though, EYP-XXXX. that find in safe to And

it's population When very chance. Last risk So be far, anything one as would here obviously, acuity the you whom But at enroll, it question a expand efficacy as big compared from was you to to this won't the good statistically And can well Again, hit that that achieve able we're an in visual have with these around to number that. or we certainly extrapolation suggest go value that the data meet. that the is -- trial, again, happen get trying process. trying is again, now. trial not a should you the a an iterative thing we trial perspective, the in data, primary over looks once and to From way we the more design that's inferior That's specific we'll the design suggests designed safe. EYLEA. a optimistic trials. looking way. extrapolate and trial endpoint. to be that we're able be that's And months, that and six that's that DAVIO But risks

the in X criteria trial that. did DAVIO X inclusion/exclusion And that wet saw Our And DAVIO to quarter protocol reflect by is is Phase X on patients really largely in those will influenced criteria the those didn't. this year, who protocol well think we AMD inclusion/exclusion target set. I that start and was of the third who

commercial And if think Scott everything. covered in. can weigh any perhaps we hope there's I I So, comments,

Nancy Lurker

ahead. go Scott,

Scott Jones

treated examining need percent our such Thank a will of for to this be therapy. the patients, large there potential But currently a Sure. but take is you the we're step percent of think to question. the marketplace. back there the still And said, Jay exact why in certainly think we I for believe about as a correct just patients for

aging you that have But [indiscernible], going we an several currently As a in what's if know, it's very occur next about to population. AMD, the think years, it's large market. you

a able have meet appreciably expansion of an needs. the retina undertreated We the of have to expanding isn't number currently very be market. patients And specialists those We of to diabetes. diabetic number retinopathy with

for more -- a every the demand it's day. growing need So, that just is durable we we're think therapy, meeting

there Jay the patients an coming have again, for enormous to appropriate But most think opportunity is the the to move bring as I'm certainly we we So, in durable evaluating a we believe to will in said, certain currently be come years. just which therapy that build we'll for as us information more them. marketplace. we're a

Nancy Lurker

your questions all Georgi? Hopefully, we captured

Georgi Yordanov

again Incredibly comprehensive. and Thank on you the results. so appreciate much, congratulations it really

Nancy Lurker

you. Thank

Operator

Thank you.

question comes Yatin from Our Guggenheim. Suneja next with

may question. with proceed your You

Yatin Suneja

guys, on congrats Hey result. the

for Just a couple me.

First Phase is the X study. on XXXX

think is the of EYLEA I we there injection that I a other Just think is confusion to investor about community used comparison. thinking out as and one or

So, and X with what come that that delivery is understand right right just that'd ballpark is the at help how the Can you like how seems you poor obviously, to the right be run could can QX, study to to think study. us might maybe the long it it -- you the data? Thanks. interim about take the about study might you it? timeframe way helpful? Any going then is in on to look the the run by was to on Phase start us that, enrollment are report conducting data in center's readout And be you give talk comment for

Nancy Lurker

those No Jay, why problem. take don't questions? Sure. you

Jay Duker

Sure.

for very thanks usual, as the Yatin questions and So, insightful.

recent I non-inferior a say visual would high wet of comparison that the at to involved. in a been of non-inferiority trial, you have primary standard in has a how And size what is AMD Once trials. is acuity the were of our all the the standard designed, used of level, was margins endpoint the first and care the the studies that's care needed trials of prior -- setting your what comparison by the were study determined initially, by LUCENTIS be. was statistics The

So at visual very any studies a could the non-inferior look were level, recent acuity. at high one of that

non-naive trial for point system. The the previous population looked at we're delivery you a different poor patient However, as population. therapy that looking was only a out, patient maintenance at

the delivery ways, in patient some the comparable system ways we're that population in would So enrolling. poor be some to trials

is monthly group that. control month EYLEA three, our EYLEA And LUCENTIS. was and times monthly was then group control after every their other However,

a for other month, treatment to out as have group, the our given the I'd every studies. that a will control a as these of I which in like potential anti-VEGF believe also months, dosed EYLEA be control supplemental bit we after group that bit well, first with a of And there's three for any different interval. So different point unique is

are So to they're rescue to longevity given going the many say, previous our the there of also the I'd action trials, comparisons patient population, some criteria, differentiation. wet AMD of the be drug, of while

high very do the trying have anti-VEGF visits molecules they the a two than been these previous extended long-term, or what which release, some we're at which account be sustained we're over again, initially lose that intervals or because at gain to different working not we're the in what out but those back perhaps know that are of Faricimab, year we that might is -- pointed inherently of or drugs to can't what had. the been still into over for as of Because it visual patients level, their the make Nancy maintain into safe. beyond necessarily beginning, the the we EYLEA extended is disease, real drugs, to branded helps much So world, with to do, our trying replacing have give gains patients who patients for

out So there unmet continuous treatment. there's a we And that's definite what need aim to for provide.

Nancy Lurker

Yes.

will X also the which XXXX. just in question, the Let wet we add results half to was, report second that Phase your of me Yatin, last on expect out we AMD

with track to all patient. as the stops all earlier, quickly track of possible. to as we for we're timing of So year out the but variable, enrolled on is quarter on stated we're patients And still our of as we're enroll being a enroll first pulling this, to this course, third

Yatin Suneja

Got it.

with what question, FDA that on of more one program? update exactly detail the can I the like Just -- the be if you're on little this asked regard to pausing cost us the that a study just exactly driving provide bit XX to do what may, may more YUTIQ you

Nancy Lurker

good Yes, question.

an at guidance people lawsuit filed another it's FDA, And not. recently by called a combinations. This result As by may new a down to guidance company know, that product. others again, against but may apple an FDA particular their was was related court. new genius handed of the that was some drug-device as the The on issued decision

for be result, guidance. result As want of issued case to more as a that, studies new they the And with that's the FDA products, a some done. And YUTIQ XX.

doing we So we are that pivotal will any studies. anticipating requiring right be multiple impact don't EYP-XXXX, Phase studies. already two now see X instead of one now they're study, because We on

XX, the EYP-XXXX, had So we study any excuse impact YUTIQ -- see we for planned two do that have studies. now one YUTIQ on me, is and to guidance don't on we unfortunately,

very So nice time, an we huge to a I've money lot is but YUTIQ as product, have a line it's revenues, nice, as the consistent extended you put into to over often going bottom to can profits of a period is going growing be don't some It nicely said. drug steady in of never because deliver to it. imagine,

are drugs. However, large these not

study a And on doing become another result, to XX for ROI YUTIQ the XX so of X for us cost YUTIQ as Phase see problematic the may

Yatin Suneja

Got it.

approved of more will to should till NPV for study you It it basically XXXX, seems get studies, two decision. retrieve, an do given but right? So not multiple required ROI that like have be or

Nancy Lurker

Yes, exactly.

Yatin Suneja

Okay.

Nancy Lurker

steroid was do And uveitis. is benefit strictly again, XX. YUTIQ we a the financial of what has It decision with with to six-month me delivery this to let just do a on nothing for YUTIQ, nothing reiterate, believe

However, a that's large uveitis category. is not again,

XX over probably orphan is YUTIQ it an we've disease. of So, that. to will And XXX, time. probably as YUTIQ XXX get it's a of subcategory maximum said, always XX million revenues

studies. see it's X that But again, do to on the pivotal we you ROI, two when very just So impact XXXX. no with Phase do hard

Yatin Suneja

Very nice. much. Thank so you

Operator

Thank you.

go comes Kim Our ahead. Cantor Please next Jennifer with question Fitzgerald. from

Jennifer Kim

Hey, everyone, your from congrats a on cold. all the I recovery good wish you work And this quarter. fast Nancy,

Nancy Lurker

Thank you. you. Thank

Jennifer Kim

that a Maybe at to I Yes, you're you questions data think to off, months few I start ASRS. going here. present XX mentioned have

Nancy Lurker

Yes.

Jennifer Kim

you spot, the additional what in of XX-month months Given six said, to is like data? see kind sweet that that takeaways hoping are you

Nancy Lurker

why you Yes, that's take Jay, question. great don't that? a

Jay Duker

Yes.

of by So I'll trial Phase the safety. first start all, again, is primarily X saying,

safety that's in injection want not you'd have issues, to related, longer-term Certainly, problem there's make if expect study. a that we expect it So the you we any. that no early sure

once If get because again, you in We those. have didn't have few burst the the see vorolanib we of a problem of the dose would expected we of first weeks, study. either related, that's that in early

Number we wouldn't to exists. study, is XXXX the this reinject we That's number the that during none didn't any while two of anticipate safety issues months want make last new we So three sure one. study. in

on would approximately months. nine so the And based to expect implants the vitro and and animal in preclinical we humans data, in for release

for need when supplementation, a injections. necessarily give the might of go Remember, weeks, nine some three free an we disease patients with to would LUCENTIS not drug EYLEA saw shot, of that longevity although even two immediately. can that and the patients expect in reactivation that get anti-VEGF we some run a But you or out out, be XX%, implants the as in between So or action up we of eye supplemental to months but would months. expect

the And see so the we would expect drugs run somewhat out. same as of to

to any a we've the would very to were perspective, in to the a as months So anticipating with and going safety first if in months, said, six know, confirm minimal through we really efficacy, we year. I label really a respect while that And want see every you happy as for pivotal issues, of few again, safety trials. we from the think

longer data argue they six that happy it will could patients again remind label may useful, except deem one go not you efficacy that beyond allow the safe. be to to that retina specialists if months than So the are

we patients nine a go up and some eight, were able six was to months to while So supplement. label months, we may in without have of XX%, DAVIO, and

data is important clinicians. to that so And

they be they might months to choose six reinjected though little may to extend in bit patients, a even longer. that So able certain

Jennifer Kim

opportunity your agreement on the Betta. Is And amended terms a with now maybe DME? plan Okay, look into can or give Phase DME exact And the I agreement deal? sort with guess, RVO that with to biggest is great. another that planning to you able there the you color that Equinox, there you're the your license are of note that? trial has takeaway question of over on priority taking related X on And any still

Nancy Lurker

Yes.

answer me Let that.

as with to for of we're the them. have beta, pleased extension our So, partnership very

original role would that we payments negotiate them all was struck rights exchange, that and China, is they that as gaming anticipated we license in was was that always in agreement agreement course, the recall, may them. to for In and you in and what ability rights to XXXX, was As well we where the anticipated, of have that we, in reduced that part the XXXX. for payments of milestones as of some owe exchange part

it formal that typical will won't go that us of And and them But to they So your pay China. there's we milestones, rights the will, the as details that. say, royalties it now we into well. suffice for to gives of in course, XXXX

all outside world addition, the going occlusion. of before me, first prioritize before now excuse that done China. may believe to now And with In to yes, of Ophthalmology retinal around mentioned us the DME comments, are have to gives in indications I out, vein now DME, rights back be it rolling will we delivered -- locally state his

So as then will retinopathy. AMD still about we the we'll And certainly is nonplussed that and third proliferative what RVO. a we'll DME initiate study now do think diabetic thinking do would

is be your initiate answers Capital that's should sometime early careful, our a to to determined. question. be we timing be have able The trial year. next Hopefully, We of expect RVO obviously, that yet of But DME to do Management. we

Jennifer Kim

was that there perfect. One there has trial just small that last should just single think costs terms know about put YUTIQ that's Is hold? a I modeling the is sort it we on now trial? But quick Yes, anything anything on of of XX. question in been

Nancy Lurker

answer you don’t why that. George,

George Elston

the to to up the the over benefit we'll Yes, million that reduce probably is going that near I million to spend XX term pick XX X we certainly next months months, think won't spending X in anticipated spend. probably we're

half of the assumes near does which of unchanged that Phase first our our into the help in certainly we're So cash also year. from second XXXX. next last though the is quarter, starting X That runway that term DME quarter cash in guidance Even the is in

a news it's is which good environment. cash near this term, pickup So in

Nancy Lurker

Okay.

Jay Duker

which add there's what is about clinical indirect team. I is de-minor may And which Nancy can more if some, it, might I thing one benefits, the

studies large on were studies the the well Although, we can to as needed still and weren't studies, manufacturing group. focus more these studies, as and they track therefore they two EYP-XXXX

Nancy Lurker

Very yes. Yes, point. good

Jennifer Kim

Great. Very guys. helpful. Thanks,

Operator

Thank you.

Jen from with Yale Laidlaw comes & next Our Company. question

You with proceed may your question.

Yale Jen

your the Maybe for previous Thanks of taking for morning. is a congrats add this one. of questions my system progress. and follow-up Good a

Just Just was a retinal ahead vein of the assessment market and reasoning? have other DME the or economical the reason follow-up. curious placed data that occlusion or terms of I guys in you

Nancy Lurker

unmet DME a market Yes. substantially is But has a larger RVO. with larger unmet just than need. much, market much still an higher need. that is a DME RVO Not

as the broadest you basis. when number you have can you put So impact at return where your on where obviously, of the as capital, a to for patients, well have look look to at most patients

was easy overall a So week to prioritize pretty decision DME it make review. that to

Yale Jen

going the is start those prepare X and manufacturer year in Okay, stock terms is for the ones, next in first get at that Phase to been later this progress or two the the you one aspects that Was study trial? of done great. quick into year? And already to of guys helpful. That's still very

Nancy Lurker

Nope.

trial. ready the products all for to Our go

Yale Jen

And will this of year? one or in that remaining the is extinguishment quarter, you continued that maybe you're a last the a Great. the one-time for Okay. here debt be have for that of question housekeeping is event

Nancy Lurker

that. take you George,

George Elston

I'll that. take

won't unamortized the with It's entry, a and And you non-cash with accounting the just So, loan. was with CRG so was it an what discount a one-time repeat. know that it a non-cash. It's that is? refinancing associated

Yale Jen

it Great. and appreciate Okay. I a really congrats the for Well, lot. thanks progress.

Nancy Lurker

you. Thank

George Elston

Thank you.

Operator

Our question [Operator Wainwright. comes Yi with Instructions] Thank Chen next H.C. you. from

You with question. may proceed your

Yi Chen

questions. my you Thank taking for

just apply technology some relativo regulations there FDA new implied drug Durasert the well it to clarify, the as with question respect The it as technology does companies the were and first to device, non-erodible to it for to applies

Nancy Lurker

Yes.

our a combination me This regulation. number just me drug ophthalmology product, by it's way, And not applies is to just and specific so Let even let couple things. of or it products. just a the Yes. of to device non-ophthalmology reiterate a reiterate, ophthalmology even

is So a FDA you and a anytime require has is device have more quite data. definition drug add, with to I a the now the device, of might broad, combined that

this The market. YUTIQ And just always doing been previously than particular because being that It but based study, that is the on also qualifies was around add more it. is -- we to it study I it's XX in And XX, So XXXX want was reiterate the work promulgated. anticipated they injector. under anything XXXX in one ruling in not the case, implant. difference have came all YUTIQ out the we because regulations an to need way on clinical did the obviously, that these the doesn't had more again, is a delivered regulations. a But not

clinical on to need they as with XXXX, which indications anticipated So multiple we regardless. I the studies, said, always

Yi Chen

just there's for no the agreement, licensing pavement pharmaceutical upfront And to you. right? confirm better Thank

Nancy Lurker

That is correct.

Yi Chen

the the what Okay. trial group? the for X the of in be used second will the upcoming Last year, Phase in control question, NPDR drug half

Nancy Lurker

don't Yes, Jay, you why that. answer

Jay Duker

of a will consist group no sham EYP-XXXX injection, At will there control. control this so active the be point,

Yi Chen

it necessary future certain active think you as point a Do the Okay. an will the drug control? in be against to of evaluate --

Jay Duker

perspective. speculate we time, We really regulatory can't from believe on that. the At current a

in minimal. the future. usage non-active the are could products is that for that advisors discussing But them necessary. DR this permissible. sham approved two And But still this while not in is regulatory space our that's of that's with now, current FDA control because belief so of is As change in there

Yi Chen

Thank Okay. Got you. it.

Operator

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

Nancy Lurker

Thank you, everyone.

EyePoint Pharmaceuticals (EYPT) 4 May 222022 Q1 Earnings call transcript