ISEE - Earnings call transcript Q3 2021

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning and welcome to the IVERIC bio Third Quarter 2021 Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Kathy Galante, Senior Vice President, Investor Relations. ahead. go Please

Kathy Galante

XXXX. matters in filings risk events the of statement. any risks cover materially filed XXXX Litigation Officer; I operational, that welcome description Mr. bio and Officer; bio's differ call. Chief results various to in Chief conference Pravin you Officer; Reform Chief Good Dhaval events Simms, and actual to you will be we that matters. differ Commercial on Dr. or SEC the are detailed subject I could IVERIC future to on constitute from Mr. for Chief bio's forward-looking to These for the today our IVERIC and a and factors Desai, forward-looking October cause of that Officer. actual Operating forward-looking particular refer materially Westby, Keith research today provision to President; Officer; Executive would to Act the David Glenn Representing the Carroll, that many like Dugel, statements expressed the are financial those Form X-K Securities expectations Financial results statements current we in factors that could These make. and purposes XX, regarding statements affecting morning Development Private to Mr. IVERIC Mr. business development Chris Safe Sblendorio, to relating Dr. cause Chief and under remind included statements statements from making risk Harbor report our our of

representing date. not and only views of as any be subsequent any today addition, In our as represent relied as upon views statements should our forward-looking of

by some the these to I any we law. Glenn. over forward-looking we update required will so do statements to disclaim While except turn now call point as elect the in at obligation to future, may

Glenn Sblendorio

year for to for be morning, motion to our call. set we has IVERIC for pivotal in good the third you bio secondary to degeneration, first-in-class for to our our clinical AMD. second Kathy XXXX Zimura treatment patient Zimura Thanks, opportunity for expectations. secondary GA Geographic retention been of everyone. macular our In conference quarter age-related a pivotal continues as and or GATHERX, GA, best-in-class exceed Thank plans in joining or AMD, us accelerate the trial and Atrophy, of to

are targeting than be to injection XX-month rate fidelity XX%. We the greater

Senior and the GA for committed for potential process AMD, of of parallel, launch in retention treatment the discuss In entirely of are GATHERX trial approved. launching moments. ophthalmic experience potential. we leader Drug a to of underway blockbuster leadership We and with well hiring already franchise, with for drugs as diverse Novartis, healthcare Simms AMD. leadership from welcomed team more accomplished U.S. for than President successfully Chris In where managed experience Christopher commercial joins the and operations launching a clinical retina a maintaining also preparations experience, years XX commercial patient the with Officer of are which Vice begun. commercial Chief commercial Keith of Commercial August, he is the if the Zimura commercial us building few an seasoned infrastructure We're assembling the team a secondary in Chris to or has Beovu and NDA New in wet Application, will

new campaign for served for a brand ophthalmic included Novartis, positioning Genentech's business Before Lucentis. marketing which new and lead as a he launching creating

achieved to regarding of several have are the Zimura We thrilled execution program. pivotal milestones our major

our months four patient ahead in July, First, GATHERX enrollment in of schedule. completed original we

plus the XXXX, closure approximately last the one analysis. for during of and database are top half on We to needed track after enrollment for line data the time second patient from available initial GATHERX be year of

overall the a received Special from is SPA, agreement design of that the Second, first believe written under NGA. only FDA the and Assessment, We SPA a GATHERX. we for Protocol this or

analyses, SPA who the basis those provides in nascent design looked the proposed at to on the initiating development by XXXX. analysis protocol Zimura intended by of potential accelerate in few procedure stages trial, for form AMD. GATHERX SPA impact an a the on earlier Pravin a clinical we provide this FDA on trial third, provide moment. to Zimura post-hoc of will also are showed trial moments. which to and which where the process And official an intermediate we is has on Pravin not of Based the details will in guidance the more additional a GA evaluation familiar, clinical we drusen AMD a trial in the NDA. X and a written these For of details that sponsor plan with Phase did a

continue cash our runway and public We with later in to fundraises in for proceeds million prepare sheet invest first-to-market this also by and preparations strengthened could accelerate opportunity, balance capacity. launch our us offerings commercial believe cover Zimura approximately We enable in Zimura $XXX manufacturing of will and call. raising net million these in October XXXX, Dave $XXX and respectively. to potential best-in-class what our also be for July

U.S. Keith. create the is delivery AMD now call as plan population the and indications, sustained-release such Zimura over The plans in turn in This potential with main commercialization the in addition, Zimura our continue patients Zimura. company and the pivotal we the priorities for shareholder for accelerating we for additional to for to will to preparing retention execute of long-term I on today In technologies intermediate our investing Zimura exciting for multiple for lifecycle of in in potential with are value. invest time an program GATHERX the order expand as us initiatives patient the to to additional

Keith Westby

morning, and Glenn you, Thank good everyone.

be of of one in ahead after in patient this the patients As to needed XXX approximately U.S. schedule. months our further European available If data FDA approval the the top Glenn time patient second four GA positive, completed expect enrollment file plus line are GATHERX Zimura GATHERX priority and major is half in timeline, last original the the XXXX Based enrollment applications year July the GATHERX mentioned, enrolled, A we Medicines of the to the analysis. with on we marketing for patient with database drive for and retention Agency XX-month to trial. of thereby for and for us secondary we lock to results de-risk XXXX, aggressively AMD. plan clinical

injection for patient fidelity targeting the trial measured of We through are than rate as XX%. by greater clinical XX month GATHERX retention

resiliency as expectations. our We are enthusiasm, staffs and thrilled dedication are with far patients, they exceeding and their the physicians of

injection than XX%. greater goal our today, of clearly XX%, As of of than fidelity maintain greater we continue exceeding an rate to

fidelity As with which a and number statistically calculated progression for significant Injection show XX-month or most reduction of consider sham, our the XX administration months injection comparison, dividing expected rate by reflects of the patient's the be total GA because and is injection of fidelity to at XX%. fidelity injections, drug and of number sham. actual important sham stringent GATHERX into drug measure the drug timely We in trial injections, eye. total by the the patient retention it a

in early on data to and but to injection our observed GATHERX. continue protect the to we of integrity previously focus observe potentially increasing also only the treatment effect not fidelity We

in results the clinical in rate the compared or and GATHERX corresponding Zimura committed for GATHERX GATHERX. effect the maximize many safety in further the motivator GA is X-milligram maintained quality reduction sham GATHERX. secondary for the positive GATHERX a clinical XX-month in of results to GATHERX trial. control XX mean retention throughout over either and the leveraging X.XXXX profile XX.XX%, to believe at are the Further, group trial, supported treatment to increasing and are months are key group investigators efficacy we retention early for was trial, that growth These positive positive a as U.S. GA enthusiastic the for of in XX-month the participating therapies currently principal believe EU. approved of XX-month and With no observed in we There that the data p-value the by patient AMD

are for Turning If of recessive patients. to results treatment the positive clinical this support our for Pravin. an disease; potentially after trial, patients statistically and the believe for of GATHERX. from we trial call the trial to Stargardt I patient for significant, XXX in as results additional initial or time. referred turn disease your autosomal the line Thank approximately could of for disease, total therapies Zimura the plan STAR We to ongoing. expected you either are is screening XX-month XX EU. Phase application top to currently Xb clinical will approximately approved enroll enrollment in marketing a no Results Stargardt the trial U.S. from over Stargardt are now this approval. There

Pravin Dugel

endpoint results the of prespecified to us allow the with in that, FDA original highly with measured discussions the on trial, met with prespecified preferred for XX that significant the hope that analysis. to with points. FDA believe submission will further of at clinical analyzed I Zimura which FDA reflects analysis you that AMD significance with the FDA of GA highlighted The completed time We the a for using primary same are method which months file Thank SPA, analysis, months. GATHERX GATHERX marketing development the the it's parallel Zimura for post-hoc application plans as NDA if when trial by preferred an future Glenn the results secondary rate result an strongly be for supportive are all marks at underscores the trial. Keith. would efficacy believe or our the fundus original using the FDA and statistical the in estimated area pivotal autofluorescence XX it's of of those earlier, GATHERX the solidifies endpoint it a file for call results, with for you, The previously mean endpoint the to MAA SPA growth for indicated GA based for all current alignment agreement and positive joining a our in XX-month used primary will from using In us the morning. analysis FDA the this NDA the The GATHERX efficacy clinical GATHERX FDA's relevant meets part together considered prespecified to a slope overall ongoing we an agreement Zimura the approval to with GATHERX consistent GATHERX thinking. gather be design a EMA. formal primary well. as SPA you in Thank with Zimura,

available to for has which to are GA effective subject and patients cause blindness with specified excluded country that criteria no GA We which involving believe, therapy also safe in the this Zimura is be GATHERX of a obtaining results, the leading the potential inclusion our GA. program, In for there patients with clinical approved treatments we GATHER patients. for extrafoveal our and foveal

As GA slow the part overall growth, blinding the in central of rate of lost Zimura to look the relently would to potential addition program, investigating down into disease. this GA which analyses progression to we of through evaluating supportive in be the has GATHER fovea, vision progressive otherwise the thereby preserving forward whether

GA we're development in mentioned, clinical these to inhibition validating important further also stages believe patients for population initiate which recently of de-risk stage extrafoveal competitor's Zimura intermediate difference GATHERX occurrence plans prior GA. with with that our reported fovea-affecting assertion extrafoveal a results, Glenn progression earlier clinical the trial target trial observed, to believe GA, of selection greater that was As complement only We results with rates our a in the accelerating in in a AMD, our that for potentially XXXX. patient support plan GA. versus We of by a in the of more is X patients Phase

studying X intermediate activation in plan occurs, these support for that a hypothesis GA AMD XXXX. believe Phase further initiate before may even results be disease We we to progression. intermediate in believe complement Zimura driving our AMD also in where We trial

post-hoc X-milligram in of prevent XXXX, by and approximately of intermediate committed iRORA EU drusen such Zimura to prospective of Zimura over Nonetheless, analysis UCLA progression the drusen by treating is are incomplete slow patients be GA slow that and of of of the observed a believe leap disease. associated complete X in of fully a including reported down impact look or progression progression with decreased in population. from to with chosen the Italy, enroll potentially RPE AMD, million These to individuals United with GA of trial and/or but of post-hoc Germany, AMD. there of that, with potential if France, between forward the the with we of Institute of retinal this of the the was disease. treatments are should studies, iRORA will was Zimura and or group to down We have In X only Therefore, GA retinal group with the the the the prespecified cRORA, atrophy significant course estimate Doheny We AMD In results and AMD five as of progression be million cRORA the the being Dr. X-milligram we the increasing for United slowing consistent these GATHERX. the Zimura a difference early could changing rate Vas sham Kingdom. observed. outer The population at analyses, States observed time, would results may the altogether with not Eye to substantiated an intermediate drusen Spain prevalent both progression and analyses Sadda hypothesis-seeking. outer on decreased countries: also AMD, high-risk intermediate individuals delivering for stages or sight-saving atrophy GATHERX, subset in rate we to be considered analyses randomized RPE

to international group. double-masked, XXX an trial randomized, per be sham-controlled this with intermediate AMD treatment expect approximately We multicenter patients trial

treat to all follow and patients XX months. for expect We

if We including European with with Drug and expect this marketing positive, file to The positive with Agency. Application that the recently the of post-hoc EURETINA, application medical of presented of of in the supplemental FDA and the be trial authorization Specialists. GATHERX world, Retina Retina data around sufficient U.S. the supportive Supplemental data AMD conferences Society meeting data the a other data, New analyses Medicines earlier may from together and annual American Society major at GATHERX were stages

stages that complementary to will in we Zimura development and to previously strategy have of multiple a a forms impact fashion AMD. that intend both and stated execute We involve IC-XXX

studies target are a preclinical engagement and tolerability have preclinical number IC-XXX of for We additional initiated and and planning pharmacokinetic studies.

New FDA GA We expect or IND, the in of Application, in AMD half to the XXXX. Drug to secondary Investigational submit an to IC-XXX for second

as business Zimura. evaluate and additional to On retinal a obtain plan opportunities diseases selective you over turn now We to I potentially on the an Zimura's to to sustained product market believe to well-positioned your approval, leader. focus a continue time. franchise; to regulatory AMD release development build Dave. a for and, are candidates that front, we Thank technologies subject on with expand targeted delivery for basis we indications, for Zimura for rights GA call to will and commercialize technologies the

David Carroll

I'd press morning Thank cash our expected you, and to Pravin a like from and our highlight items good this runway. of and morning, expected balance release our everyone. update cash few year-end

This decrease to totaled quarter, or million, share or loss net our a the For net share by was primarily loss $XX.X per $XX.X driven R&D for million, of expenses. $X.XX compared per XXXX. in $X.XX net QX a decrease loss in

our manufacturing additional ongoing activities for a to in enrollment personnel. and progression expenses in and patient reduction the trial, R&D decreased in GATHERX increases due expenses, Zimura R&D therapy commencement Our offset of by gene increased

expected We runway. October, balance approximately the range $XXX net Turning raised cash In estimate cash to our to underwritten in year-end now year-end and public $XXX proceeds million between and in $XXX million. we million offering. cash our

including Zimura the for continuing of investing potential NDA launch of Zimura intermediate mid-XXXX. sustained-release of delivery We that planned through GA, the also the Zimura and our or expenses outside acquisition expenditures current advancement over MAA additional program. IC-XXX Thank back and are preparations launch Zimura call Stargardt's, may or from our the or of studying payable to salesforce fund Zimura the in least GA, in approval of for that potential time. Archemix potentially resulting for as our and Corporation business estimates Stargardt turn commercial development Glenn. in-licensing intermediate ongoing product the the Excluded to these of cash the expenditures estimate be GA, technologies any clinical programs an plan, to GA candidates and any in now potential based of technologies preparation sales milestones for disease actual Zimura, our trial, your I'll indications initiation will expenses are development such capital estimates AMD of any additional you pursue. development on for to and associated or sufficient clinical operating expenses, These at and AMD, in our of from potential continuation related for in or potential filing we

Glenn Sblendorio

thank Dave. Well, you,

made we're we XXXX. As with year excited to comes close, in progress a the the

you will patients we focus These AMD be preparing also technologies plan your We're initiatives, in look additional this XXXX, for to U.S. now Zimura operator we with Zimura you forward sustained-release of accelerating two such ahead top I Zimura. Operator? want priorities. look development progress. continued of of patients call intermediate so for for our the lines with for GATHERX retention to questions. to the on We turn time we also over the we any up in the and lifecycle I delivery the will as as with updates potential the your thank trial for continue morning and open As and will to investing to can providing commercialization support. execution in the

Operator

question from Stifel. ahead. first [Operator Samimy go Instructions] Annabel Please with The comes

Annabel Samimy

thanks taking congratulations a have on question I the and my rate. for progress. on quick questions Hi the guys, fidelity

GATHERX, could many And how help from it's is to I that remains than it statistical way compare and if for your these a the in patients high, very obviously, that one have have the to moved GATHERX? they've progressed how your from a understand ask programs for how of study So how GATHERX. next, competing see know there I GATHERX I is are, into And Maybe fidelity second, how how changes patients that it greater And technically question, the so high? GATHERX? guess rate to there does if powerful patients XX% you can you've that us compares from powering fact, if seen into reported data? similar analysis

Glenn Sblendorio

It's Glenn.

So three questions.

take the do I to we'll Annabel? first. Keith, for you question deal want think with powering that

Keith Westby

is power actually GATHERX overpowered of based So the so safety, on we're for efficacy.

at you efficacy actually we're GATHERX results on the for and safety. study, based from If our they're overpowered clinical look

based enrolled the the would subjects for XXX So GATHERX. on or to well commercialize, at one the as a and treated sufficient least numbers year FDA at dose we higher least as at dose patients we plan requires in GATHERX have

shore on So it assumptions GATHERX. continues our up to

we're GATHERX. for So powered that's how

Annabel Samimy

And do conducted have in trials sense other compares any it you of that how were to GA?

Glenn Sblendorio

question The asked about you Is fidelity. had compared other injection to trials, correct? the that

Annabel Samimy

Yes.

Glenn Sblendorio

I'm going had Pravin for to of I'll look also at and think, we it him I to let terms color is in answer Pravin provide come in this actually of since some terms up But something metric, a the others. how with that. let comparison you

Pravin Dugel

a able and but enough possible. may was as in stringent before, technically So counted then straightforward. retained. and being And years least this the reason not that to epidemic, I has been may in come that ever at or be patients give is would Annabel, where an be injections pandemic, that in really as as parameter various was those provided the know missed back. don't us I've were not study. for and a so patients despite this the been been patients, regarding transparent we ongoing a as gap And There And global PI never really for or certainly to in very has then that wanted providing may the come parameter, and would in This in treatment, the while good come XX provided, studies. concerns be

the and up what the expected transparent used you has by be the that as number possibly fidelity And actual don't divided it injections, been believe injection parameter before. be which in stringent that given therapeutic of that's came would know really patients. we ever is active number is we get. in can sham, transparent or So, with most about that that's as I parameter

the same for in sham use the the and However, it have the that of best actually being is drug measure the patient's I'm information that hoping it that utilized others or really simply provide will reasons because eye. we

Annabel Samimy

any then, last about or GATHERX, in GATHERX And from question the fresh moving GATHERX? patients patients these into if are

Glenn Sblendorio

Keith, think correct. anybody I that's They're GATHERX we all from new don't GATHERX. move I believe to patients. had

Keith Westby

[ph]. begins That's correct, Glenn, all new

Annabel Samimy

Okay, back I'll thanks all. the line. get in

Glenn Sblendorio

Annabel. Thank you,

Operator

The Please & [Operator Company. comes go Instructions] Yordanov ahead. question Cowen next Georgi from with

Georgi Yordanov

questions all the Thanks congratulations so for progress. and taking much our on

don't easy As growth. you How to you really have competitors' remarks, is given talk with patients, the results complement maybe have in limited patients lesions? patients your of GA label lesions these to GATHERX fovea? extrafoveal be Could And only at lesions percentage mentioned dramatic do it your impact impact showed you if could about what inhibition lesion expect extrafoveal the just prepared the diagnose extrafoveal all that your is to successful? on

Glenn Sblendorio

you one? Pravin, to that take want

Pravin Dugel

lesions. So, higher. patients they're The of extrafoveal exponentially have lesions with greater patients that. that no there's much, clearly than mean, I fovea-involving estimates number range end-stage doubt much about

Now, now in had is they practice, started as ophthalmologist's that with and I soon were happen which the the as those retina happened neovascular those which patients dry AMD, were into are is degeneration seen so will will specialist. referred really this general and be is question office. anti-VEGFs. convinced patients severe. the in with the necessarily they're really same unless That's in the They in. quite office we've very referred degeneration in that are when those the are the retina at there much in with not where a office. Patients treatment, bigger with The why is macular really thing macular those is ophthalmologist's neovascular because no not those optometrist's specialist's patients And the movie were like optometrist's treatment. the weren't before retina are patients office patients And much the office referred really And general specialist's patients. really not right and

also line well earlier at a who as is disease, from better to our an you Their here slower-growing but extrafoveal are the XXXX treat are but These the patients with can show that making workforce as usually wouldn't day, down fundus. patients no we've And of vision believe very in results, far as geographic straight labeling this slow as sentence safely. may make to are down able we discussions our reason to geographic atrophy the a is there's not competitors' which inflammatory atrophy. be symptoms. results, if for be reading we patient that what the has the type, a very with occurring. process, haven't inhibitor finish One delta it FDA. able in One a the that see It the only that premature fastest-growing there disease a the fovea-affecting extrafoveal see is slowed had in are population, we the targeted believe, as far is Now, have concerned, concerned, the we're And labeling or as chronic the want may look patients we've be down that. the at straightforward. it would not end a done geographic get earlier with geographic the the approval proper may to atrophy because there's complement But geographic clear results. atrophy atrophy spot. that fastest-growing slowing we which is able blind clear the stages a diagnosis formal questions be of because to I it's can fairly from to And any not it's

with expectation be labeling. emphasize formal that so. premature we haven't would FDA So, had is again a It any to discussions regarding I label. But have would the broad we our that do

Georgi Yordanov

perspective, requirements you ex-U.S. regulatory versus you And do the any then, potential from strategic updates or remind Asia us, for And differ European can expect U.S? a partnerships?

Glenn Sblendorio

Yes.

the really to and is prepared infrastructure GATHERX As I in strategy. right focus the commercial mentioned our now complete prepare and remarks,

So that's now. our priorities right

team position I in getting The a a but time about to completed. organization, the U.S. think the outside still we're working is talk small GATHERX on at aggressively partnering very diligently right good hiring.

what right let you question? right So talk we'll of partner to we I the know second will you look time ex-U.S. about that think, Keith, and at the the is. to part want time,

Keith Westby

was So And with approval, related but to I be would GATHERX think at study sufficient question haven't with I'll do this discussions just formal this the we point for had regulators we that regulatory. preface design ex-U.S. believe ex-U.S. ex-U.S. the

Georgi Yordanov

you This progress. And is Thank the so great. much. congratulations all again, on

Glenn Sblendorio

Yes. you the for And thank questions.

Operator

our to Sblendorio for like concludes This the turn back Glenn to I remarks. any would conference question-and-answer closing session. over

Glenn Sblendorio

Thank everyone, listening in thank for and you, you, today. operator

As the on execution throughout and early rest you you've the of year. to look year focused heard we remain we from team, and to the Bye-bye. forward speaking next

Operator

has now Thank today's presentation. The conference for you attending concluded.

may You disconnect. now

IVERIC bio (ISEE) 9 Nov 212021 Q3 Earnings call transcript