EYEN - Earnings call transcript Q2 2019

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Operator

Good day, ladies and gentlemen. Thank you for standing by. And welcome to Eyenovia, Inc.

Second Quarter 2019 Earnings Conference Call. [Operator Instructions] As a reminder, this conference may be recorded.

would Bui turn from I over conference time, Tram to The this like the to call At Ruth Group.

begin. may You

Tram Bui

Good Eyenovia's John Chief Gandolfo, second Eyenovia's Officer and and me welcome Chief Officer; earnings Executive are and and Medical today Ianchulev, call With audio Financial quarter Sean Dr. Eyenovia's Chief conference webcast. afternoon, XXXX to Officer.

at to release, June press quarterly will also for release the Earlier well results be XX, We quarterly this Form financial XXXX. website afternoon, report press the The press release XX-Q, be Eyenovia announcing on read encourage eyenovia.com. as on Eyenovia's which company's available everyone issued August XX. and as filed months ended today's SEC a on report three with will Eyenovia's

We this is the is information safe be under addition, Please conference those will be and future today from making at risk certain associated company's harbor Litigation Reform note of Actual there Private that due will Eyenovia's by forward-looking materially statements. website call differ statements covered webcast archived with caution call, this Act. the uncertainties being Securities company's for these could business. discussed to results the or forward-looking management the provisions implied stated and on reference. call In during that the listeners

implement, most including to, market retain estimates timing to primary new approvals capabilities potential in limited product opportunity statements ability and are our our product not others develop results; financial applications obtain and regulatory qualified for, trials; ability in the and our risk and fluctuations recent for key our progress by submit detailed design, releases existing results and filings, including our statements candidates, for and candidates; filings. press cautionary such and manufacturing, risks, and our including of Form to for marketing candidates; on our to personnel to identify but SEC the ability product forward-looking of product maintain XX-K candidates; annual regarding These our Eyenovia's clinical its subsequent related subject to to commercialization, ability of strategies attract and initiation, contained and report in a risks our the trials, timing, and number the

that This contains of XX, may securities applicable conference after as the law. accurate this as statements only conference call obligation Eyenovia call time-sensitive to except this or information events the any to revise is by update undertakes broadcast, of date or of no XXXX. required August reflect live forward-looking date be circumstances

like Ianchulev. over turn I'd to Dr. call now the to Sean that, With

Sean Ianchulev

Thank you, Tram, and welcome, earnings XXXX everyone, quarter to Eyenovia's second call.

pleased to seek are steadily front as back we've by We change stage to advance quarter continue late diseases. eye the of made paradigm clinical very our and the we last pipeline treatment progress the of and

CHAPERONE Phase Just U.S. we III topical has billion initiated $X recently which estimated MicroPine myopia the progressive study market and first myopic to be for in potential an progression. to treat therapeutic the children our represents opportunity

glaucoma expanded lowering MILAGRO addition, In this intraocular by year. trial population to MicroProst in for for end an working pressure the we're the the initiate of of

potentially in the The underway. to rest slow in now is second Phase product myopia MicroPine let of first program children. highlight our study CHAPERONE progression topical our candidate of and class for our treatment Before which the year, III I discuss first well our is plans is me the enter to

of vision they threatening approved a currently back series treat As no the lead of you including, therapies progression are atrophy. remember glaucoma, retinal to diseases and eye can which detachment may myopic retinal to FDA

to based LAMP that. had on study literature atropine. body low slow study to from and XX% been the ATOMX, by using to is aims myopia a XX% The all dose Our progression which the which generated ability of is to ATOMX CHAPERONE III study growing registration the up Phase change studies scientific demonstrating

The which of of June which age. plans will control a investigate the The is MicroPine and atropine XXX study reduction launched to progressive trial years randomized enroll safety X double-masked multicenter U.S.-based children for we Eyenovia's in efficacy of XX proprietary myopia between CHAPERONE topical the micro-formulation. to study using more than

will Subjects receive be to two treatment with or of either concentrations randomized placebo. MicroPine

change endpoint study of primary from the baseline through error Our the is in months. XX refractive

of addition our our lowering chronic angle intraocular patients CHAPERONE ocular study with for we're the closure the IND Phase to of III for the of pressure MicroProst glaucoma open initiation glaucoma. In in MicroPine, preparing or program hypertension, angle application

technology be which elevated have very a contraindications enroll by approximately We're have beta this will therapy. times X of for approximately excited about expect blocker no our year study patients XXX trial which trial traditional us eyedrops. double-masked single to or plans who of begin patients IOP give will to a it the population end million to the and who to potential we treat this trouble microdosing very registration as multi-center The the U.S. often patients while glaucoma PGA bring broad also administering novel in

MicroStat, remain expect XXXX. a to stability FDA preparing new file the to on we and complete respect focused drug application in laws With and the with registration

significant million and tropicamide dilation a which As and X tolerability believe mydriasis pharmacologic in surgical we micro-dose the reminder, and is million pupil comprehensive eye estimated annually efficacy of ophthalmic MicroStat in dilation in our for a U.S. co-formulation performed novel improvement exams, and diabetic the XX in office-based which is the speed represents phenylephrine

like would John to call I that, to With discuss over results. turn the financial our to

John Gandolfo

afternoon. for Thank joining Sean, this thank you you, and once all again us

for having proceeds, public we aggregate position I July this offering proceeds the would improved our our to company. completed successfully of note I raised in in Before quarter aggregate for results financial financial million $XX million which like the and XXXX, in our $XX net underwritten approximately review second gross

NDA for continue an advancing offering their we necessary study at end of for MicroStat we rules a the developing for the year our this MILAGRO raised believe CHAPERONE and the fully to time MicroPine amount Phase type. baby for underwriters by working study executed SEC's moving We The and the our current overallotment shelf maximum program. under option have the our into this MicroProst III continue of capital possible

With our highlight will XXXX. the now months XX, financial said, June for results I three ended that

XXXX, a second $X.X second share quarter XXXX. a the to of this net approximately $X.X per of share compares the we approximately loss $X.XX loss $X.XX reported of For of for or million quarter and per million or net

primarily totaled approximately of an million in $X.X increase company's advancement Research compares to the continued the the second XXXX, XXXX quarter same and was drug and The XX%. clinical approximately for expenses period development for of the to this of $X.X pipeline. million due increase

quarter periods. For XXXX, fees expenses increase XXXX, XXX,XXX the an This $X.X million costs, expense largely of XX%. rent were second result compared increase general of the professional and quarter between approximately the the of personnel and second with for was administrative increased of approximately

Total operating $X.X and for same expenses for XX%. period XXXX total in XXXX, were the million of quarter expenses increase of the of an approximately second approximately $X.X to million this operating compares

not closed approximately from in As cash This of company's amount Eyenovia's June does million net in the was $X.X XX, underwritten offering balance XXXX, proceeds and $XX approximately which equivalents public the XXXX. million. include July aggregate cash

requirements and to proceeds recent XXXX. We our into cash fourth the hand on from expect to of offering sufficient that the our be operating meet net current quarter capital our

remarks, call financial over hand statement our That closing remarks. Sean to back would for I like the to concludes

Sean Ianchulev

Yes, thank you, John.

the submission as the work In as open serious that remain needs our our developing XXXX. for forward to look execute ophthalmology. questions, first-in-class MicroStat the second to the medical necessary we in order complete I'd we stability call to as we like the we to materials milestones therapeutics reiterate of NDA year, in and to manufacturing Before unmet continuing committed to to in our MicroProst registration for MicroPine tackle advance clinical on and the of half well

recent we sufficient continued and their With underwritten capital these capital offering, our goals new to like infusion our we’d public the of shareholders to believe we latest thank support. of existing that have for our all achieve and from

questions, open calls our I now operator? prepared concludes to and That like the to remarks now any would

Operator

question our Kaplan Ladenburg And from is of coming Instructions] line Thalmann. the first [Operator with Matt

Your is line open.

Matt Kaplan

wanted CHAPERONE MicroPine, the of programs is in Just stages how far but few a initiation here, I dig III so early the your study? the it's to of going into Phase study, enrollment guess with

Sean Ianchulev

proceeding need another our XX really or probably we think forecasted. months board with kind is was as few this forecasts proceeded of the original as study enrollment plan though months trial Yes, within The and have we'll as I and more has at launch. to plan, of point initiated come is to so on well been everything enroll but that sites

changes to forecast. no So that

Matt Kaplan

running many sites do how have line far? that in so up And and you

Sean Ianchulev

of sites close plus we’re the next exact we get the Well, QX were in now, to starting a by activation as number to I of slow know year. that planning XX sites of don't but

for around think I the XX the is number whole total of sites study.

Matt Kaplan

with to respect MicroStat specifically you need the then submission, on terms have are where I the preparing you And to of lots submit the NDA that to guess, package, and CMC executing to the in manufacturing stability done and yield NDA?

John Gandolfo

mean can maybe I that. I so Yes, answer

has We are pretty much changed. the as quarterly place update last same nothing at the

stability along waiting complete the to that the of We’re from to all we've last NDA had submit proceeding the the a XXXX. is all and And malt timelines the according in quarter. in

Matt Kaplan

do study proceed here MicroProst, that end to by with faster the the the I of could something What the CHAPERONE in that timelines respect to study? you is think track that study, of then for And on of terms guess than potential year. the start

Sean Ianchulev

it’s six than we’re later going months fast a But although not nine the so think will starting it's I to to that months study as forget it remember single faster, two. relatively because you -- we’re don't the later, CHAPERONE. six doing be study move later

that to same the burden with and So the time population. major of the that program at was a larger improvement

very endpoint hypertension to include the chronic is the trial trial to and angle we a now not the we and population closure expanded So only this includes expect ocular the it well in open characterized enroll we this study are data that's but that angle so yes, that the relatively looking once the in see months, study have also patients fast, will able be to XXXX. results enrolled, is that three of we're to so from and fast relatively fully

John Gandolfo

Yes, our mid quarter. to third

Matt Kaplan

things; launch approved, terms of be for preparation for couple number commercial are two just and then in to since preparing you in MicroStat closer you're you about one, talk to opportunity more number where relatively to And and MicroStat the -- product? your that two, able thinking getting that about -- having can then commercial questions

Sean Ianchulev

is the so updated recently. opportunity commercial Yes, something opportunity. It’s on a twofold we that

the every that’s and screening you is the have market comprehensive the the that, happen One million for diabetic based XX major clinic addressable market, year retinopathy dilations for eye of clinic-based that where exams market.

office required which segment, mydriasis the another the base agents too the that’s is is drops. very There million a to in again, cataract this for surgical XX in surgeries patients of of separate anywhere and set year probably unlike palpable market because on dilation are paradigm the current where also X which used market between mydriatic of markets, patients most XX per one with multiple and but case

surgical market a In to because that usually the drops happen per but surgical of reuse single set not indicated that in patient, the doesn't it’s it’s setting.

microdosing, be that hasn't years. Obviously, eyedrops we in the about market the past have are the the So eyedropper changed to over can differentiated opportunities. the that less that technology where preservative terms product addressable of to compared did we’re we exposure we legacy both XX mechanism the excited horizontal and and delivery numbers XXX to very to with think big really this

stability same co-formulations, used for the commercial are so we commercial it the so the that and at is preparation microdose and even us two on President required the know to give the prepare. a bit a Michael of are hired preparation happening of launch And of single time, studies, as alongside we really administration eyedrops and more separate you here formulation the a commonly it’s runway is the a little marketing versus lot Rowe, which our zeroing Vice

facilitate actually who partnership on have opportunities partners already the that ground framework We’re are feet and that also with opportunities strategic that. at established their may looking

happening can and the start to more getting there a granular plans. commercial of lot probably So we the coming as quarters work in

Matt Kaplan

outstanding question And one that shares of then for the selling maybe I you John. guess, offering have? last a number

John Gandolfo

$XX.X in have this million outstanding at We point time.

Operator

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

Your line open. is

Yi Chen

with comment you MicroTears, the occur on on OTC launch year? the is still still to MicroStat track to could is track and question is launched XXXX be next it registration, First on

John Gandolfo

and we before, OTC on the you any program sense so want standalone. Yes, a companion It is launch sales maximize ROI to doesn't the something it and as that know to we've the It's efforts. really Microsoft. sales as mentioned a to make force

require know. purely synchronizing, doesn't clinical are we it’s as So and studies that you any again, --

So it's you in timeline know which XXXX the as tracking updated MicroStat program, the alongside really NDA. is the for

not are MicroStat joined them launch. or ahead the the more anything imminent we and So of less for hip. of MicroTears planning at Both are

Sean Ianchulev

To as urgency high of MicroStat plan same XXXX, way, it be We XXXX we XXXX. on in get right now do say to launching that in so time so and no registered the another XXXX. in get a at sense do launch longer registered it could still There’s priority to XXXX.

Yi Chen

you question higher in Second should first is study continue is XXXX, quarter study expenses logo the you operating as and think much the the higher lower how starts of appeared do go we the for the remainder enrollment to the expect to the and the in expenses quarter second operating but than appropriate? be CHAPERONE during

John Gandolfo

at when XXXX, at site we’re I about we look cash third per of end through quarter So an of looking $X.X the quarter. burn the the think million average of

said, during quarter. being a One then burn. $X given about much quarter drug are million, manufactured average but upon there the may linear registration that clinical that But quarter much formulation a a for million be being type $X.X and like million. not Now $X be it will maybe and batches how how quarter a it's of course, depends

if recognize it I little go it model think million I and modeling, up So $X.X at I probably could about was would a down. linear that but

Operator

coming from from Esther line our next of Rajavelu [Operator Instructions] And Oppenheimer. is question the

Your open. line is

Unidentified Analyst

a a for a been developments CHAPERONE, looking you might regarding potential when have partner I then partnerships any what you. presbyopia question, safety potential and first and timeline the here? Esther. question for on the interim receive and Thank we Fergus] second [Benjamin have update in might what around It's are be there in

Sean Ianchulev

study with as no No, there prespecified discussed has and the endpoint we interim. FDA. The planned month XX that’s are

enrollment We in the update timelines. will on periodically is is bookmarked no planned there but interim that

through is trial We want want maintain follow to patients we maintain. to final and full endpoint. the the will We That of integrity very those important. endpoint through

microdose with five course Of LAMP fact also people into are safety I ATOMX, which and informative, of in data. in all the the some those efficacy, on them terms for are year way studies, ATOMX can very think results a the therapy of eyedroppers and with and to look of topical

partnering. was The second question

John Gandolfo

with Partnering presbyopia.

Sean Ianchulev

we it's It's our It's have Yes, development we We of full is so programs. defined our clinical out that small that came on are something Phase R&D the are It pipeline a development prioritized launched efforts -- around very we that. presbyopia presbyopia program. ready be and think current have hands a III path a now. right opportunity. team the and to now into great

can reading and a really especially and be first-in-class. opportunity, Presbyopia day pretty important are you much everybody that very XX today's not when glasses, is age and changing like in market solution is over imagine, for can people looking independence huge and and therapeutic best is a the a lifestyle game

be we that and think seriously next something execute the be great and would to very pursuing this we partner, problem over this a can right partner hope months. six are will with XX to So the we discussions, we

Operator

And have you. questions day. in for gentlemen, at today’s time. Everyone, Ladies I a am showing all further may conference. thank you Thank no This disconnect. program, today’s great you concludes this and participating

Sean Ianchulev

you. Thank

Eyenovia (EYEN) 12 Aug 192019 Q2 Earnings call transcript