EYEN - Earnings call transcript Q3 2018

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

Operator

Good day ladies and gentlemen and welcome to the Eyenovia Incorporated Third Quarter 2018 Earnings Call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to introduce your host for today's conference, Tram Bui of Ruth Group.

begin. may You

Tram Bui

Officer; welcome press XX-Q Call press XXXX. which and Dr. release the today. Third ended XXXX be months release morning, Chief at everyone Quarter Ianchulev, Financial Eyenovia's encourage Good website Earlier announcing Officer. three report Audio to financial Webcast. Conference this Medical and with Officer We and Chief on be www.eyenoviabio.com. will Eyenovia's September quarterly issued will XX, are John Form well filed With Earnings SEC Gandolfo, as The read Eyenovia's Chief report the a as company's also morning, Eyenovia Eyenovia's today's and Executive Eyenovia's on and release to later available quarterly me Sean for today results press

In submit trials, due or under of Safe and for in releases our and and with Eyenovia's approvals financial risks for implied on report time personnel filings trials, this for or candidates. is subsequent filings. stated conference will certain reflect to could Act. Sean and information archived as statements XXXX. webcast but revise risk securities the our call to of call, there progress date that, opportunity forward-looking company's to details that including note is such live statements. that update Litigation fluctuations forward-looking a statements limited including including the to Securities Eyenovia the related making by applications only regarding and its clinical statements by will not the contained call Actual initiation, broadcast by Ianchulev. or maintain required timing, timing our now turn Form obtain call regulatory XX, to annual call in company's future Eyenovia's the number any of these results, in We uncertainties to press from no most applicable the those of statements This product cautionary associated business. Dr. of subject XX-K and undertakes forward-looking call conference circumstances today information to obligation to the is maintain results qualified differ forward-looking be caution Reform These of ability the after With candidates, our ability potential results requisite except during key contains be risk attract other at recent and the to that market website listeners reference. materially Harbor covered this Please of provisions our over and for the our may November Private discussed management conference to addition, this events being this is to as law. I'd Estimates and product like the be sensitive SEC on the accurate risks date

Sean Ianchulev

Thank you, Third Conference to Quarter Earnings everyone Call. Eyenovia's and XXXX Tram, welcome

for program our we've MicroStat study now Phase our our first the month. for with Over of of worked application diligently course we XXXX, initiate acceptance clinical IND this advance the to mydriasis, expect to later and III

over other We myopia for studies four forward for progression; III initiating the also months. and closure MicroPine Phase six to for chronic-angle look MicroProst to glaucoma two next

solidate the paradigm very we platform, eye ushering upcoming remain and we in branded the which microdose our in conditions. trial, to we recently proprietary this of have in work the we support continued technology cramp high and way back further a treat to and prospect the As precision excited develop of Optejet

in PGXX by as Clinical the well review at fourth presenting getting as active been recognized study journal peer Ophthalmology. have multiple publication We quarter the conferences our this coming past ophthalmology

with litigation announce that to previously disclosed of Corinthian. former certain are addition, In pleased have our shareholders we we settled

Before to our eye. deliver names the the I technology, we we're system and ophthalmology; and for selected trademark but ophthalmic programs deliver proprietary can to therapeutics. container our After the into precisely like Optejet appropriate for to of activities again enabling for optometry micronize using and our [ph] spoke Jet as meeting micro closure the and memorable for to brand also identifying of our broken for have we parts: Optejet, E only recent conferences, microdoses submission I name drop and we to with Eyenovia; physicians potential and dive The ophthalmology was Opt into liters would relationship down highlight be between itself printjet helpful physicians, for technology with. not which X the X clinical at brand drops name for decided three

management quarter, beyond leaders our York paradigm the the delivery in of discussed on and conditions, little the conferences eye study, we presented complications usability we the of conventional droppers. the demonstrating the rates close previously believe drug is Nobel-technology technology success As topical eye to the York. the And pleased able at conventional Optejet previously, to Conference, changed non-incremental side in Innovation well recently at name the which introduced XXXX coat rate reported eye for front Ophthalmology. the were is is took far we the has multiple of ophthalmology well Summit very In advancement of as Eyenovia veterans the Surgery New also technology opportunities we field ocular noted for our to just Eyenovia's at Chicago. of a some the going Nobel More and we studies have accurately, and from as XXX Ophthalmology and story XX% we late surface Ocular while Optejet American past the recently, potential to Eyenovia reported industry platform delivery New above and News of hope In Ophthalmology toxicity potentially breakthrough technology the which Optejet epitomize in of topical the we years. key opinion XX% third recognized advantage the ocular as eye-dropper present have brand with our PGXX the Academy in effects. treating which for Conference and gently share for September, reducing that and the case to at our

previously PGXX Optejet. and of the in investigated study full in announced, by analysis of all delivery that study As of completed of lowering over effectiveness very and our latanoprost piezo-print in time self-administered Ophthalmology effect than X.XXX% Review it of microdose less accepted results the August we studies. XX a administration Clinical volunteers XX In has pleased successfully time I'm publication. IOP Optejet healthy XX% significant These the was review of improvement XX% standard microdose nearly eyedropper The latanoprost peer which represent the eyes as well-tolerated the Peer in multiple care the the using study, subjects microdose the demonstrated medication Journal for subjects. self-administered successfully of was

are MicroTears. addition, turn were over-the-counter Phase we less III baseline, to In results these the trials. uses very we Phase other which as lowering approaching robust which or move them is to would III seen clinical our with programs, effect a consistent as achieved with microdose like studies IOP now focus I effect Overall, drug leverage initiation case informative to single IOP for registration our intend ahead XX% than lowering and the the preservative and eyedrop from conventional XX% eyedrop a latanoprost. a XX% standard of in

early the start in mydriasis dilation application a comprehensive IND me exam, of Let the retinopathy very October is to our as have which for standard acceptance FDA. submitted MicroStat with the from MicroStat for as are pleased pharmacologic pupil We diabetic eye received part well of exam. and

the first The to With move double-blind will each half ahead and of XXXX. data green month trials trials XX expect be trials, this the multi-center the with our we initiate Phase trial. studies line superiority with in to subjects top announce in light III

with tropicamide XX tropicamide versus be currently examine will trial main tears. The at the versus phenylephrine; The will in point phenylephrine examine studies eye we to combination end of microdose XX have ophthalmologists second exams of baseline. could year, a phenylephrine, dilating our phenylephrine offer product create estimate novel-pixels in over microdose change opportunity first pupil versus and each optometrists will We We performed Optejet MicroStat. both eyes. dilated significant combination opportunity the anticipate and microdose artificial could and are million to the existing compared there tropicamide [ph] compelling and the diameter a trial market method the that microdose which microdose minutes for of tropicamide the primary versus

important platform same provide FDA technology. about MicroStat opinion, could excited in entire delivery of fundamental is the our as all Phase use III of microdose very context our validation it are as We meaningful programs particularly program. of in opportunity This a our the delivery the technology

the in progression agent anticholinergic profile atropine remains progressive is of unacceptable of studies XX-fold XX% the rates adolescents side to increased detachment, have to success could next nearsighted. in China, what to vision prevention nearly are an eye loss children are XX%. visual by suffer retinal of potential But X show trial X efforts, back formulations Our impairment randomized retinopathy, and treatment expect all myopia myopic five-year major academic our by as the disease, U.S. effects. of and up myopia is progression MicroPine crown collaborative estimated pipeline. large nearsightedness. half an of current to error the remains elongation Recently, eye which and by There believe of the an treatment In progression Myopia these as therapeutic who refractive of patients. of a the an slow number there severe XXXX, myopia reports from despite to institutions by with million a stasis axial data permanent we population increasing increased no increase to collective we significant jewel to FDA-approved progression increased atropine, length alone and examining lead up of kept causing of published characterized for in the an the XX% of safety in program,

a the to offers we standard of believe to profile piezo-print while with that and we doses. technology microdose also within thanks ability the Nobel effective, However, patented atropine, safety compared tolerability deliver the microdosing have better Optejet,

the As in early over rapidly program our XXXX. efforts we to in are quarter, an study of starting MicroPine towards the moving the III course Phase submission we the look accelerated IND forward and third

John in short the this treatment with cases in optic neuropathy I resort to to market In by call With half our able the MicroProst our XXX,XXX we our straightforward in this Phase to its and physician first dry half breakthrough the fourth priming and third to results. is Chronic-angle the patients we program, the estimate using in China. to physicians program, strategy complete chronic over-the-counter could consumers Our provide in offices eye market. XXXX. to increased Despite we for of Optejet manufacturing indication. candidates the that, diagnoses Optejet, and pressure closure discuss other $X to for the U.S. lowering submit glaucoma is to physicians that treatments the parallel introduce of characterized once introduce the initiation be pathway need, registration, with order an excited IOP to MicroTear we the MicroStat and through before therapy accounts With in would able intra-ocular turn of We chronic-angle be of the XXXX We're ramp estimated financial to believe the paradigm all first open-angle glaucoma we technology, early over for development like formulation technology in indication. through will up, approved introducing medical that approximately in we introduce IND aims closure again for our up be the This market. to to application with to billion microdosing MicroProst significant believe country. along around MicroTear trial the treatment to enable currently III off-label. the improved glaucoma our and may in-line effectively very

John Gandolfo

you, Thank joining once you, thank morning. this for And us again, Sean. all,

share for million approximately For a compared the $X.XX per third quarter $X.X $X.XX to or of net share, approximately of loss development $XXX,XXX the in to $XXX,XXX compared totaled quarter million loss net reported third or expenses per of XXXX, of a Research XXXX. XXXX, XXXX, for the quarter approximately third and the same an $X.X for XXX%. of increase approximately period we

expenses drugs. in Third R&D drug the compensation continuing included company's expenses formulation of with increased approximately increase of stock associated and reflects and $XXX,XXX The expenses clinical quarter personnel, development of non-cash the pipeline development engineering expense. research XXXX

For the compared and $XXX,XXX increase administrative third were quarter $X.X quarter of of XXXX, the expenses approximately for million to XXXX, general third of approximately an XXX%.

Corinthian expense and operating compensation is non-cash general increased the administrative result personnel XXXX approximately administrative litigation XXXX professional associated quarter include and general aforementioned Third with stock associated were a as settlement. period the fees expenses The and and XXX%. $XXX,XXX of in a to expenses compared expenses total $XXX,XXX of increase company. XXXX, $XXX,XXX of public being with $X.X well as operating Total the XXXX for same third million an approximately costs increase for of approximately of quarter expenses of

issued As cash from allowing our $XX remarks. would us at financial statements pipeline and III the have over to of the company's registration. balance call million September the over-the-counter months That the date balances believe we we for development Phase our sufficient XX like for financial hand closing next programs towards to to of cash the was concludes I back statement Sean XXXX, XX, approximately that are least progress remarks. and

Sean Ianchulev

technology our success ancillary clinical we our all that believe pipeline our stated Optejet John. is execute such PGXX, studies you, well-positioned the on as Thank to of our ongoing multiple Eyenovia through milestones. With and validating shots continuing is

Over our prepare with we remarks. for the MicroProst prepared over-the-counter horizon. open our diagnostic strategy III and forward expect applications MicroTears We'd trial now MicroStat for MicroPine the several for like concludes IND commercialization months, registration are on mydriasis to this next to continuing Phase In to to month. our and programs we call the parallel, for look our of initiating the Operator? questions. That develop

Operator

with Our Thank Instructions] you. question from [Operator Roth first Scott comes Henry Capital.

open. now is line Your

Scott Henry

Thank you and good morning.

have believe data do MicroStat, two them on study. of planning concurrently press going wanted to of IIIs. speaks initiating in XXXX? I do the confirm. I first just of starters, your have both Phase still and Were to you're Phase first you III believe to For half we should to I them release for the

Sean Ianchulev

immediate trials studies a morning, includes other. Good but simultaneously clarification. program first same of first Yes. the as Those two of The quite operationalized -- program the will the ultimately, the III outcome within also every the quarter studies. of about maybe half, the outcome we're dilations minutes, really endoscopic [ph] patients. and lot this is In which with XXXX. maybe at not also program of million sometime Phase good looking very within at is a case, be is weeks pupil a Phase This happening have That's is year. I XX meaning fast-paced yes, a results indication for the XX exactly III outcome, do both time, mentioned to relevant we which dilation. each exam. a But We're And it's expect the Scott. very earlier, in talking big

Clinical for So, look of of and Ginger program Operations our Classby at done the really a is who has and time execution who line. she has decades, prepared acute VP that we really

XXXX. Phase other short amount is the able each there be on we'll to in execute of sequence of fair I trials think a confidence sometime of in fairly those bulk and studies that have the results III

Scott Henry

give for us the INDs could prepared And congratulations MicroProst MicroStat MicroPine? this on you apologize time the the and your you for I but in mentioned IND. remarks, if line

Sean Ianchulev

with really because talking that fronts prioritize the very again, bit. some investors we start over in formulation a We've on months, the years that globally. appreciate the program and very also in the we U.S., we few not understand need of and unmet significance. progressive and only big myopia, but Definitely is urgency a program past now good MicroPine quite the to had success MicroPine for I'll Yes. myopia and

precipitation goal the XXXX. INDs the the the in INDs half for she few for are to really of to programs looking MicroPine the the to next have the the first both both Phase first and and initiations and the the IIIs follow of in initiation as both enable MicroProst trial Again, in whole months, we think [ph] the year. and of I initiate Phase before next ultimately the MicroPine enabling of and is MicroProst, and submits mentioned of point we've IIIs the INDs in half the

Scott Henry

run that perhaps should for in I to Okay, statement. G&A, $XXX,XXX or a with out we to is than rate you. that? great. R&D, if the lower the for significantly QX? litigation, expect And a regards pull that final little just And question QX on income reasonable the a Thank then ramp up then

John Gandolfo

the think that it G&A, we at those expense end the compensation you stock take and alluded we as to to run out XXXX. non-cash once the the expect to, of I litigation-related look we expense levels through

In terms to of getting expect the R&D, that we we more studies. do the increase involved start in as III Phase

going probably $X.X million $X So per about we quarter forward. be anticipate areas the roughly to it in to million

Scott Henry

Okay.

$XXX,XXX the a in in the comp, a non-cash was So one-time be will expense line or G&A? that event, that recurring that

John Gandolfo

that next for but It associated wanted highlight so value because it's company's That's progress hard it the so to tied event, it's the the to why quarter stock it's it's options one; stock to one of extent the stock it fluctuate a non-cash it's company, I secondarily, [ph]. with one-time It's because it price. the hard an I to price, describe to prior as estimate. from of to stock to price [indiscernible] quarter. is absolutely tied and the

Operator

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

line Your now open. is

Yi Chen

for that taking MicroStat question. the previous III and my My from trials? first one or is design the of three you can please Phase question Thank is elaborate, different trial how you

Sean Ianchulev

versus the randomized here combination, of program one a phenylephrine is control the and the and the tropicamide program the III Phase design the FDA. of really design very two III Phase with microdose registrational is Again, them of the study the and components. collaboration a of our down study was fixed Yi. close -- Hi, with includes or this microdose. Again, working in It's microdose

is also the is study the conditions So, which outcome done between dilation versus did which photopic different on earlier again, dilation And is where than study scotopic This from of phenylephrine, difference we we change versus used amount baseline. photopic and conditions. point The in very in very that condition, case millimeters microdose microdose pupil baseline X the of have scotopic your is light When for starting earlier ambiant conditions, and versus to have scotopic conditions the your X illumination. at X photopic of was is to do really you about study. the which bright X you millimeters pupil our tropicamide.

response with photopic range much more have which going would rate us lot to a dynamic run be the allows in of So the outcome. pupillary greater we're

outcome fixed validation use control, study same that Second, that combination and tropicamide which second demonstrate tears run studies is again, FDA where against microdose true required artificial the specific trial dilation prior before. by really pupil the a is seen in XX literature another a that the the and of we've effect studies placebo that control. we when minutes much And Again, which the response, we are will those our is pupil on the the pharmacodynamic was phenylephrine. dilation. very optimistic Again, with reviewed would you study we've are dilation mydriasis to and

of exact Although of the those should again, XXXX. the results different definitely are and in first see. the we time that available we wait can But be combination trials have the the in quarter for and results formulation hopefully again, terms points exact before,

Yi Chen

it. Got

Just trial. Conventional be to in that clarify. III eye drops Phase will correct? not used Is

Sean Ianchulev

that's point. good Yes, a

is microdose trial purely first The comparison.

phase, show the the You contribution the there versus in microdose fixed requirements the components, is no to be have components. same combination FDA eyedropper could because And microdose form. as it of you but need from

against just also component you're against case is eyedroppers, microdose, microdose not right, second other the versus those fixed control. running drops. we're the which combination the eye Yes, study we're So running not we're doing for

Yi Chen

it. Got

Okay.

simply for registration at the process, filing is you or all a of it forms? for any that Regarding do the expect hurdles OTC MicroTears,

Sean Ianchulev

hurdles and is to hurdles. every with My job day Yes. expect deal

we again, program the through. see will how have think I to comes

monograph of and the benefits artificial over-the-counter is really the registration. it follows of tears One

at same you not to per the microdosing foresee so of technology but the time, coding the [indiscernible]. doing will surface it is application where the the the can the directly indirect do run We way multiple tears we through because studies ocular studies in artificial clinical and enable se I can think registered, once we marketing delivers versus and tears the an different we how post down be registration, road

of So probably a of post registration standard technology, tears. road the do the artificial studies marketing of down benefits a we'll follows highlight the pathway lot but from the perspective, to it

different of focused to to think other programs. is in launch team all they product, assurance, of really of up, have I the than you happen. regulatory to ensure sure our quality is go successful these a my that scale have make all stage effective manufacturing, way our an But that all very very things again, all harmonized [ph]

Yi Chen

it. you. Got Thank

Sean Ianchulev

you, Thank Yi.

Operator

Thank to like the Q&A concludes would This for turn closing remarks. today's Sean back Ianchulev to call session. you. over now I

Sean Ianchulev

no remarks We further here. Thank very have you much.

Operator

conclude thank today's gentlemen, and the in This conference. Ladies participation program. does you your for

day. You disconnect. a have Everyone may great all

Eyenovia (EYEN) 13 Nov 182018 Q3 Earnings call transcript