CLSD - Earnings call transcript Q3 2018 | Clearside Biomedical, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the Clearside Biomedical Inc.

Third Quarter 2018 Financial Results and Corporate Update Call. [Operator Instructions] As a reminder, today's conference may be recorded. I would now like to turn the call over to Stephen Kilmer, Clearside Investor Relations. Sir, you may begin.

Stephen Kilmer

Victor. Thanks, and joining everyone, you thank morning us. for Good

during as these like you be of those may future by Factors that we most we factors, certain begin, XX-K for and with today's time. the expectations, time Act the report remind EDGAR statements SEC, of December would I make of those including we the that can the constitute remarks materially will filings important differ indicated SEC other Before plans during and the Form from with forward-looking ended which a various the section Reform to call, database results the result be statements. XX, at discussed from in Private Various XXXX. call file forward-looking on to Litigation prospects, Actual this make XXXX, about for forward-looking statements on company's making recent www.sec.gov purposes Risk we Securities the year our on of annual accessed

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

as at may any our forward-looking any update to we forward-looking future of to not be even these should disclaim representing statements While we views point, date views as specifically obligation statements our so elect do These to some if change. upon today. relied subsequent

I Daniel. and over turn our our Financial Dr. are Officer; now Chief White, Scientific Clearside today call President Chief our Deignan, the On our the to that Officer. representing With our Raymond, Ciulla, Chief Officer; Glenn Chief Daniel Chief said, Medical Executive and call will Officer; Thomas Charlie Brion Commercial Officer; Noronha,

Daniel White

morning, you, joining you everyone. us on Thank for the call today. Good all Steve. Thank

at market we Brion opportunity the on near-term as out call. commercial our begin, Glenn uveitis. will the story, and couple Academy discuss organization be a will pipeline, the in time through Clearside will up for Q&A. take provide presented some lay And Ophthalmology, Charlie American today's we and let me analysis approach the provide I'll an weeks PEACHTREE and will of results. discussions an of catching we have our financial you we briefly will I that finally, you agenda our our ago at on Before the call then summarize update on non-infectious will update our Tom for additional

story, describe benefit of diseases moment eye. of our Biomedical blinding who I'd are for a the treatments the For to our new to those take to Clearside pipeline, like potential

the XIPERE, formulated the between a of a candidate, Clearside's treatments Our of is the the triamcinolone studied suprachoroidal unmet of eye which and XIPERE space underserved of suspension choroid. eye lead sight-threatening proprietary that diseases corticosteroid to is is or space, acetonide the that part pipeline choroid back layer located protective is being the outer of in as the sclera. product manifest for of for administration eye retina the and

diseases Specifically, be DME. and uveitic clinical strong are like specialists' patients fight In have uveitis, demonstrated profile in of associated Phase macular useful in PEACHTREE, treatment uveitis, diabetic or uveitis XIPERE III a macro edema. lead blinding Corticosteroids study, with and the vein the retina RVO, indication. to against edema, with called successful in the pivotal the been edema or uveitis occlusion, retinal which demonstrated macro

TYBEE Phase to this first XXXX. review for Based mentioned have are has patient treatment on shown data in plan DME been NDA and also DME indication we patients, have quarter to our issues in current our steroids a past, population maintain the an believe II submit there's in of opportunity help upon compliance. vision utilization with to that patients, of the fourth we As the in we

potential the evaluating are clinical We options can XIPERE demonstrate for as that a monotherapy. benefit best from trial

CMO, to now to XIPERE approach. that working a update discoveries Brion? sight-threatening select will our call to over prioritize may beyond conditions and Ciulla, turn in As commercial the Brion new also treatment proprietary later treat I'll suprachoroidal we're provide to discuss call, on benefit brief the Tom uveitis. from our

Brion Raymond

Thanks, global uveitis about vision all X/X in loss States to these occurs and uveitis cause patients. XXXX of the patients. $X eyes affects the billion Daniel. by The expected in United market approximately is and edema XXX,XXX approximately leading is of reach in Macular noninfectious

and have for indication with therapy edema approved first treated this If their still of after new with approximately associated with of the be today's trial, uveitis Additionally, with clinical comparable edema team by to excitement the FDA, thought instilled macular confidence option XX% hearing profile. patients leaders not treatment. the course macular patients a will explain of XIPERE's therapies may while our the uveitis. in PEACHTREE been publication study, The regarding and points XIPERE we've from recent the

into our presented we In trials results to our important we FDA for team inflammation Additionally, the all grown able playbook for to on the functional and eye education detailed Clearside most the a and considering have FDA the and past launch working all market XIPERE. and we've differentiate that manufacturing. since uveitis dedicated should launch programs, packaging the progress of patients track we'll at commercial training drug approval. our with reimbursement, particularly and accepted made of areas our ready We're and approve anatomic we're team of a the physician in readiness, ensuring ensure received in XIPERE, access launch are is for preparations, were significant confident remain cross parts toward launch organization should uveitic up assembled we be locations AAO to quarter,

experience if decades the U.S. ophthalmology that uveitis within Genentech, in retina Ophthotech. ready uveitis manage brings efficiently with of reach will broad We're the specialists in communities from who and relationships and Novartis, we and patients experience the team XIPERE, Eyetech approves Santen, and Our FDA to retina be the these confident

AAO. over share it recent presented turn Noronha to to Glenn at the about like more I'd Now to the data

Glenn Noronha

you, Thank Brion.

PEACHTREE XXX XX and across provide results calls, to I'll control clinical line discussion. to and XX a discussed Israel. data sites previous Patients in in patients we brief patients the to top As XX randomized with U.S., were of XX arm, uveitis India the of p XX% those than of summary a or PEACHTREE was receiving weeks baseline the at The arms. X:X compared each measured XIPERE gained the in in with focus control patients apart this X.XXX. from letters best have less at XX met trial arm. patients endpoint acuity who This X XIPERE XX, value as statistically a with in of its week of to significant corrected primary improvement least visual enrolled XX%

well the Dr. a adverse secondary resulted XXX arm, completed resulted from an a subfield the microns XIPERE of was in endpoint, value with entered week key production of mean the administration at X.XXX. central mean the patients trial. additional For generally XX-micron reduction trial. at to Recently, XX control treatment-related in in in -- that serious significant thickness than compared statistically less with arm events the the reported trial who p baseline active to presented retinal also XIPERE the provided uveitis that PI of for profile of the tolerated Khurana, no was in analysis the given at XXXX PEACHTREE data evidence from XX% of the presentations October, Rahul Northern vitreoretinal the were Medical in American and Ophthalmology and California discussed Through a at potential meeting treatment X in positive of edema a surgeon at the Center at Academy trial Vitreous observations the Associates, Ophthalmology in Professor UCSF macular that information further the Associate annual PEACHTREE, reported. PEACHTREE clinical support XIPERE of Retina Clinical patients. and

XIPERE, at from resolved; shared X compared X.X of changes which best XIPERE two the patients following cells other the patients in at anterior the to Patients XX% XIPERE compared of the in with treatment In corrected control anterior, were main pan-uveitis, experienced with XX vitreous were analysis changes control significant of More arm. with in treated the acuity the are and the XX.X% visual were control and improvement inflammation Khurana each were compared data treated XX.X who of of of the information resolution XIPERE patients or in subtypes: week these compared XIPERE nomenclature on letters, in to intermediate, of more control uveitis each using data baseline at significant two were anatomic when information of measure arm the XX%, by statistically in patients arm achieved PEACHTREE and significant patients flare arm the group, visual these patients, XX posterior XX. of to for uveitis Each the anterior comparing baseline, no compared of result, of PEACHTREE in letters for PEACHTREE week locations chamber zero, haze Each XX% improvements who third scores X.X information: the intermediate, at scales, Signs study standardization in week Dr. Specifically, and and words, week of the XX. resolution patients to across from greater were anatomic patients XX.X of eye statistically and letters, changes of in than scores letters, is three X.X, haze posterior XIPERE sham respectively. to were to pan-uveitis vitreous letters with and the baseline specifically, for at data. in in when resolved; arm. the arm of X.X, resolved, XX. each these This control where XX% control XX% the chamber in arm, arm XX.X XX% anterior,

quarter. are for uveitis by this of NDA our track to the associated edema submit end We macular on XIPERE for

our rest Officer, are over pipeline. U.S. new NDA. turn Chief the I'll We our marketing Ciulla, of briefly to Tom the outside subsequent filing plan to the pursue Medical also our on review to Tom? of to call authorizations now the

Thomas Ciulla

Glenn. Thanks,

and you that treatment and be rapid proprietary approach proprietary fewer As potential doctors that company's organization medicine many the team Clearside's provide CMO the site approach longer. disease, adequate introduction Also, following just medicine Clearside and may to sometime potential the as to October. treatments eye of reaches this relatively of But has designed the could new requiring story provide. for This I've I potential has the so well burden visits. to new efficacy it patients of the to back served believe joined to approach approach the at the treatment is know, to the the suprachoroidal enable suprachoroidal and of treatment treatment advantages. clinicians options now, been reduce having by of to in I'm remains by dispersion act maximizing

minimize other healthy corticosteroids, the associated could been intravitreally periocularly. the local it addition, with In has and surrounding whether eye harm or that exposure to part topically, given of

Phase DME program we treatment XIPERE study patients look developmental II advanced real-world combination as clinical rather are issues potential treatment after highly patient only letters six eight with with suggested anti-VEGF clinical Phase recommended. this seven In DME the mentioned, most compliance with XIPERE the month TIDY, potential of address benefit we've letters gains. anti-VEGF we burden compliant to of demonstrate the and in a alone. trial, six in whereas three In diabetic DME a May real-world and demonstrated the for XIPERE the advanced edema This and dosing, clinical next current gain TYBEE treatment. a intravitreal significant addressed patients than receives as XIPERE optimal barriers III uveitis, data approximately When are macular XX could with administering patients. XXXX, to that five intravitreal Since injections eight As XIPERE very trials. addition to mix, intravitreal most of their is These extend patient EYLEA for to evaluating first to efficacy combination that suggesting three compared approximately treatment trial EYLEA weeks. Daniel the which program More specifically, EYLEA issue these XX DME XIPERE burden quarterly following which anti-VEGF agents, maintained was in example, only as vision vision average letters to important edema. in to to trial, months could of or maintained developmental patients, quarterly gained our treatment maintain patients in in monthly we the at macular and data, to be is safety by after important referred With used have still injections diminishes in edema. has very our over of that visual diabetic completed macular XX in diabetic paradigm of TYBEE dosing year

DME now have we to our the we are to and XIPERE Phase including scientific outcomes with a for and evaluate DME. approvals forward and believe in diabetic path for We Based by regulatory and burden, TYBEE of II there's the plan consulted medical address treatment the developing program. our macular trial the advisers recent edema, potential on EMA, FDA

future excited very I'm addition, of In about platform. our the suprachoroidal

plan viral are suprachoroidal preclinical additional As to we studies third Daniel to reporting nonhuman to promising both this I'll Financial to and realize transfect gene working and from quarter approaches. we team research to, delivery. look therapy rabbits our marker to review our well full collaborations results. consider Deignan, nonviral work forward to with financial nonclinical these Chief DNA express We both call next now demonstrated note, turn alluded has Charlie? Of the and XXXX companies the leveraging over conducting as and results the an as primates Officer, potential of Charlie using genes year. preclinical in ability

Charles Deignan

to team. Clearside, at everyone of behalf on And Tom. welcome Thanks, the

development XXXX same in million research to XXXX. XX.X million XX.X expenses we and were compared for this As the morning, QX reported for our period

an in by As associated our had uveitis was decrease associated program and program, with occlusion PEACHTREE retinal cost development costs in increase expected, a completed. R&D trial partially vein that in with the clinical we offset our

were of in decrease was our expect expenditures potential that the recent from we primarily XXXX million costs marketing uveitis. up XXXX next The impact will support expenses employee-related decision and to in TOPAZ higher third to discontinue third to research million, and quarter is analyzing the for to from X.X are quarters. due the administrative While commercialization trials, of SAPPHIRE the XIPERE and quarter. overall the it development increase still X.X few reasonable and full General our expenses over

loss XXXX. share compared $X.XX in was or The million third XX.X net to for share XX.X $X.XX XXXX same quarter or per million per period the

combination come cash in September and discontinuation estimated Based and investments equivalents resources available that to expenses back quarter call XX, discussed over previously million. to will first anticipated planned of with closing we we including reduction cash, believe Daniel borrowing into expect that sufficient have R&D capacity development our the As I'll now therapy facility, Daniel? totaled our we on the the And of short-term XXXX, XXXX. under our our operations debt remarks. to fund XX.X of his for the turn

Daniel White

we has clinicians. and Charlie. of among of have you, to and Thank summarize, at to To awareness clinical potential build our treatment time uveitic working the macular acceptance for been the readiness, XIPERE's same edema continued commercial advance researchers profile

fourth to We of are confident for that XIPERE for prepared approval. and a file successful receive we remarks our This will we complete quarter the be ready XIPERE today. NDA our the in concludes for objective launch in XXXX should

call open thanks in for third Clearside to I Before significant the the I'd questions, we've like team quarter. to the made to the entire express progress my

have strong that open Operator? a have anticipate our call to questions. key capable up of highly consistently we will and on for commitment that, delivered now professionals mission. our We team goals, we With and our the

Operator

[Operator from comes Rama And line Instructions] Anupam first our of from question JPMorgan. the

now open. is line Your

Tessa Romero

this bandwidth Anupam your XIPERE side, and suggested thinking commercially, has what how about U.S.? for of are for And the the pricing training then market research be uveitis? Maybe the for force you additional one a related, required on here Tessa And is a retina potential potential morning. specialist use by what the our in size This to sales the scope product? would in from

Daniel White

that answer question. let Thank Commercial Brion Chief I our you, Officer, don't Tessa. Raymond, Why

Brion Raymond

while completed the We've early and that a we're give this band our in too to by payers. cost encouraged of our we've results it's with modeling And interviews effect seen. pricing, a little

-- top say, us and decent process alignments. improvement safety put are retina specialists training. power, trained. specialists Yes, of reps -- retina But many intravitreal many reach and remaining a XX in to our on XX profile sales retina and our an market. we with immediately are we this community between community. it's program this fortunately, launch looking able train specialists and the most efficient reach uveitis injection the territory think the have been technique. and a let's the training perspective, trials, at be But the we at our to procedure, will we sales will uveitis at some And in not through the And finally, our additional in already that of requires that multi-faceted confident From the working injection and pricing in place gives I I'm sizing. it then advisers we'll

Operator

next our Annabel And question Samimy comes the of line from from Stifel.

Nicholas Rubino

is Rubino Samimy. Nick This on from Annabel

we're preclinical in the this technology be any or use tried ahead, if or you've interested also? some know have Looking as to behind you CFC to predictions that mentioned additional the for to work may new maybe potentially your any platform, valuable thoughts you compounds? other Or gene with programs so have if with? theories work color compound I you what therapy some see

Daniel White

Brion, let let Nick, to don't -- that answer question? Tom you Additionally, add I'll I why can maybe, it.

Thomas Ciulla

in my prepared this about excited platform. As I mentioned remarks, very I'm

I some where can high expressed do to he's think Glenn, some intriguing Scientific Officer, and it led you models it in potential its Glenn, real very to need has have serious choroid ability retinal diseases work elaborate this platform. but using our levels very target nonhuman of access retinal want elaborate? Chief we unique the that to preclinical drug we treat our suprachoroidal achieve tissues. because both further, showing rabbits primates, preclinical in genes in reporter can and to

Glenn Noronha

information we it's gene genetic our of this reporter Honolulu. work, within at shown with in meeting, year was rabbits from and work ARVO So the our a which methods we've nonviral this therapy where -- getting presented presented actually earlier in and have preclinical gene used material last

thing. And this both kind And therapy. nonviral we're work. are same with the well we've where well the as nonhuman both we And of our have this doing addition, in gene really as planning we with academic working as facet as demonstrated at of approaches. In the with worked collaborators programs primates, in results, viral primates are which this have reproducible. And multiple within terms other in pleased we particular are areas of looked

looking what the In back that not models. early but of encouraging are, the addition, these back we to well diseases, distribution small We're as are some are and approaches as have of both molecules diseases molecule what data we the some of the some ready yet in diseases. the for preclinical disclose of particular key in terms of have multiple of eye we at some eye the pharmacodynamic

Operator

line Serge from Company. Belanger And & comes our the from of question Needham next

Serge Belanger

A me. couple of questions for

First, more you bit a that on the implications potential point related can little study, from and talk study the about observations in to XIPERE the uveitis?

Daniel White

that think I Serge. -- thank take... you don't you, Tom, why Yes,

Thomas Ciulla

know, study intraocular was patients is triamcinolone, triamcinolone, approaches, a improvement. X-letter And and there's the you randomized OZURDEX the in triamcinolone. As there periocular a X-letter OZURDEX, XXX versus periocular intravitreal where improvement intravitreal XIPERE, point to a that approach the

XX% helps compared X clinic. results ocular clinicians, treatment uveitis XX% it to effects, often treat appropriate side favorably the and do PEACHTREE guide to weeks trial to us it's program, XX terms cross-trial our elaborate? study. the hypertension. because And In conduct our And as weeks we you Glenn, comparisons, of do -- at required to in the point although medications completely at not want

Glenn Noronha

look XX/XX vision safety was talked reductions intraocular as aware, safety our in data really terrific And PEACHTREE. profile, we itself, as if XX.X% who PEACHTREE And times So have profile at main about those showed to macular edema, improvement useful. you're as we had visual increase improvements XX-letter acuity, you in from the had pressure. in the close PEACHTREE well well for multiple quite

and the in of encouraged really of both PEACHTREE, terms safety are in terms we So the data. efficacy

prepared of resolution the showed mentioning study. within in We of my two the third patients, of also I was remarks, third two as patient signs their inflammation had during our

and rather in in are of an XIPERE of to associated profile overall at improvements the really information the encouraging of of efficacy macular a reductions standpoint. looking terms -- terms makes unique of uveitis, as of vision at profile, signs safety in in and us looking pieces well its So in terms safety in both XIPERE from as terms in of edema,

Daniel White

debate a what it across Because steroid uveitis in specialist different treatment the macular of is among did the it created edema approaches.

them been helped with in new say indication, different -- I and approaches I was conversations some these what I interesting Well, KOLs it changes I've an openness that think, So that there of in study But the the this across new might any kind understand just is new comparing think very having steroids to just space. changes from I the nuances interesting comparing indication, study is space. very run. across there's would the steroids be. was is that any think, that

Serge Belanger

And steps an as think does -- what XIPERE monotherapy follow of you pathway those its the think RVO, And OZURDEX it development potential DME will a role for indications? ILUVIEN? look of in in and monotherapy clinical we an and the should or

Daniel White

That's a question. great

in the of months, talking regulatory this product. the considering many our as few thought I think many been we've as with leaders past for of well pathways potential

think I our that. thinking around finalizing process the in we're of

will a trying that We will we're trial understand commitment something to I there. happen our to haven't completing coming in update the what we that's made year. yet think that as And design,

Operator

question Instructions] Our the François Brisebois [Operator from comes line Laidlaw. of from next

François Brisebois

But part stone much comfortable of not towards XXXX? right the of saw A Is I very in kind that so is the in guidance here. have been this couple with I'm later launch set year? are you just mentioned now? wondering, answered how Or --

Daniel White

NDA -- fourth we're That our quarter. we is far concerned, say to we -- have guidance by going as as file to our that can only

NDA we're the need that can't going next quarter. I going by confident that the the think them. speak of on -- fourth feel confident to FDA process we look for to file we I in what But toward decide to we're our is we steps, feel

François Brisebois

That's I great. was thinking. what Okay,

of terms an therapy? go is an the something and compare you the DME was you a RVO, more just know having this would OZURDEX to DME Serge I RVO, whatnot, it And wondering, second guys line in or and more, I on thinking asked But anti-VEGFs of that in so effect monotherapy. with both

Glenn Noronha

we not appropriate have and transparent. really finalized yet have been the approach, we So

do, that. course So on of talking decided we'll to we're have, terms study we're when ready going in not what what designs. this do action be specific about of We've to the we the exact

Daniel White

But say, Frank. used right, you're Steroids often in these I will are diseases.

when compare about able been to we've think So we favorably uveitis.

and we're and decision-making same to going And our take so to as concepts. safety durability concept that as far

François Brisebois

side, because you the was pick I effort on this R&D timing the last would the one up then might just the yet the just these you in into pretty aren't RVO, that be that would terms hear Charlie, the a because, wondering was -- much couple guys information I cost DME, And of of of giving be did that months, on much when here. go I expensive? monotherapy saving, back do on wondering if guys would trials obviously, not

Charles Deignan

Frank, million focused R&D about so possibility. amount our RVO see say the want I launching in uveitis. to QX. NDA in on an is we XX approximately allocating could primarily that were to we million And achieve said, filing in resources our XX become XXXX, trials. If to But milestones Yes. million available R&D, we're we was as the related XX burn funding in trials we in spent and what of as of our

reduction can. as trials, pretty properly shutdown significant going we'll we sufficiently in So we're our of see to And expenses. a do these and

months have three any clinical or we that probably trials So don't currently, planned it's or two remaining. RVO. budgeted for again But DME of

Operator

call the for turn to like remarks. I'd questions. further closing to any White back showing Daniel not I'm And

Daniel White

your interest for you updating the you in Clearside. in appreciate We And forward disconnect. ahead. joining to now Thank we continued on call on today. you may us Operator, again our progress months look the once

Operator

and day. disconnect. today's may Ladies you does in gentlemen, and have the conference. conclude a great Everyone, you program, thank all for This participating

Clearside Biomedical (CLSD) 10 Nov 182018 Q3 Earnings call transcript