EYEN - Earnings call transcript Q1 2019

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Operator

Good morning, ladies and gentlemen, and welcome to the Eyenovia First Quarter 2019 Earnings Conference Call. [Operator Instructions].

As a reminder, this conference call is being recorded. I would now to turn the conference over to your host, Ms. Tram Bui from The Ruth Group. begin. may you Ma'am,

Tram Bui

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

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

Sean Ianchulev

microdosing two which and further with MIST-X multiple help believe Thank XXXX successes, our will a XXXX approach, off programs us number Tram, We call. the we you, initiations kicked completing year. including everyone, MIST-X study, first earnings advance and which to Eyenovia's safety conference welcome, our of Phase towards quarter validate this MicroStat novel III,

set confirmed an Surgery can that trial Cataract time to XXXX, the week, and results, our of respectively. we which Society and middle, Ophthalmic expanded program results and precision IOP the expect drugs we efficacy of work American MicroPine high trial the Administrators positive III towards we initiation diligently eye the III with stage FDA begin annual and our Refractive Society first the III MicroStat last for Phase our to of program Eyenovia for end the at in This joint in as team confirmatory present Just deliver MicroProst meeting which patients using American of lowering, technology. was Phase to microdosing registration Phase enrolling

studies. our I Before I'd our like to trials, MIST-X upcoming our discuss highlight and activities from MicroStat the review and briefly recent results MIST-X

present pupil was Our and first our dilation Phase last MicroStat annual trials, program week, achieving least pharmacologic X-millimeter clinically is ASCRS be proud for mydriasis endpoint. from pharmacologic we MIST-X mean III at very safe the and our meeting. results post-installation, of to dilation XX% at effective each MIST-X was treated to eyes trial, mydriasis to for demonstrated that complete pupil at MicroStat superior and minutes Collective primary or positive XX approximately program the statistically data were trials and which dilation. of pupil In shown for achieved study the

about Additionally, and of X-millimeter the achieving were In early X/X demonstrated dilation exploratory mild in XX treated events MicroStat of dilation generally analogies the was studies, most as minutes that post-installation. the transient with infrequent, in both rapid nature. patients adverse eyes as observed data

FDA-approved of the We III patient annual very office-based program efficiency experience combination to patient improve in that the the ocular fixed-dose surgery estimated phen-trop both eye to $XX no MicroStat States. million to we phenylephrine the are $X first and of and knowledge, exams bring the has our pleased and to as estimated other throughput believe applications aim our in-office comprehensive With and as for for market. co-formulation diabetic with Phase studies potential well the outcome United mydriatic million tropicamide

focus past and of in MicroPine, the mid-XXXX. NDA manufacturing few children. to the a major over XXXX. lots study, program year, in With prepare preparing on to our in the FDA with months application program, and component new been MicroStat this file expect at our enrolling complete, on we to working of III its to continue progression investigational look We complete a are reducing patients of Phase received stability first-in-class and back-of-the-eye we MicroStat the initiate acceptance Earlier drug have forward to for for myopia FDA our diligently CHAPERONE focused we our registration aimed initiation

will or retinal be We lead MicroPine single the a cases, and trial a placebo treatment detachment enroll children either treat advanced arm. more in decreased will are concentrations to Participants this two to vision, will this To there registration progressive FDA-approved than therapies expect of randomized, XXX be our multicenter receive that at double-masked study can equally and knowledge, U.S.-based adolescents. nearsightedness, treatment retinal in progression, a and study atrophy. time which no myopic to randomized

our growing demonstrated formulation has that this which that by holds ATOMX, We to up indication. to the slow LAMP have low-dose be studies, of evidence, microdose myopia and in first XX% However, a has potential potential the from the atropine support believe atropine FDA-approved the with body of the XX%. been to of ATOMX progression treatment to that generated

closure. allow chronic treat our ocular made patient that to and hypertension for expanded begin population also earlier include in expand discussions MicroProst to After only are expanding working FDA, not trial scientific end with but patients. population by the the MicroPine, those MicroProst and glaucoma, Phase lowering to decision expect the broad novel pressure, our with also approximately the but with to of year In the or for through III III closure glaucoma enrolling addition trial patients patients, only angle very patient X program IOP, our further year. may potentially We majority patients not application of in we we chronic microdosing will it to only glaucoma IND million bring the technology us the discussions also and our opposed vast of to patients angle believe to a a prepare for advisers angle open this with this population an Phase of intraocular as

by program, - updated FDA eye monograph this effect, program the anticipate to expect Similarly, we will to the red recently approximately single the clinical also Phase OTC itching and trial, launch lubrication. III have the decongestant into be to are program that alongside registration MicroTears significantly program. towards be tear MicroStat formulation lowering as able our with Additionally, address and and being the streamlined exposure ocular refined We we rebound anti-pruritic to our medication ocular patients. the preservative enroll XXX OTC believe products reducing developed agent We easier address a MicroTears, an which consumers. by to administer facing develop current and issues registration continuing to an will over-the-counter also

Finally, be see technology we recently we in the opportunities ophthalmology discussed of platform some successfully our where applied. could

XXX nearly value that on may Americans. the represents presbyopia these we attractive the an for is nearby causes vision to present that of issue hardening to a of the and continue nonpreventable eye's we prevalent Eyenovia. loss age-related gradual ability the lens, Presbyopia proposition As affects which opportunities, focus objects believe examine million

treatment, With Our will high-precision a to continue to proven approximately This benefit a as X I could pipeline opportunity microdose candidates. in results. addressing we explore research and discuss of that turn that, vision we pilocarpine. drug, like to associated could short-term the X issues the of is with approximately John microdosing interesting provide financial would product and us, normally an our believe to with million lasting XX people drug hours improvement indicates potentially from technology, patients pilocarpine, those in of while combined call to continue [indiscernible] for over the late-stage we our to it our advance prescription

John Gandolfo

like you all to us this our for financial the And months results I Sean. thank Thank X review XX, you, ended morning. would once for joining XXXX. March again,

approximately of totaled in quarter personnel-related For primarily of share XXXX, loss to first and the expenses Phase and materials associated and net $X the for this nonclinical $X.XX $X.X reported our direct to increase is of per a III an $X.XX $X.X the due development compares expenses, of first or $X.X studies. per a to million increase million for compared we loss of million supplies net share, or approximately XXXX. of and increase Research approximately for in same XXXX first XXXX, quarter million an approximately the clinical XX%. The with and expenses period quarter

quarter additional we and R&D our microdose first activities contracted services, increase our the supplies for employees we as three had XXXX, an of products. expanded in in addition, In hired

expense first to for of related XX%. with of quarter for rent the compensation was an first well for the approximately The approximately quarter exclude general first operating approximately public professional XXXX, period and first For $X.X $X.X costs to increase stock operating XXXX, increase personnel million million noncash compared primarily in of an of for of $X million were same XXXX, of approximately increase quarter which million. Total XXXX XXXX, entire expenses, expense the of the XXXX. company compared total million were expenses operating quarter the to of expenses expenses expenses, quarter XX%. Cash-based as being attributable $X.X in $X.X was as the fees, increase for administrative a an first approximately

As Sean the like million. financial back cash of March balance company's would cash XXXX, approximately to and equivalent statement the for call concludes over remarks. hand to our was XX, that now $XX.X closing his remarks. Sean? And I

Sean Ianchulev

John. you, Thank

I'd which was work quarter, Before entire questions, we call recognize a open tireless to great like the the team their of work. our to past Thanks hard this to success.

of ahead, the our believe to preparation program. we manufacturing submission registration remain necessary of the the We first for materials our MicroProst, falling committed now into advancing MicroTears and That paradigm OTC successful MicroPine for all our Operator? initiatives XXXX and to of stability that the Looking front- as prepared MicroStat clinical in I year the for diseases. to and remarks. NDA the of XXXX registration open questions. would to call we look puzzle we our seek another the like and making any are concludes forward back-of-the-eye and to the of transform pieces treatment place,

Operator

[Operator Instructions].

of Esther with first Rajavelu line Our from question Oppenheimer. comes the

Esther Rajavelu

sites are couple, first expectations are MicroPine. the would this number have So pursuing kind frame of you What the - a can maybe you I do on set of and the quickly enroll? enrollment think time you How on trial here? some that

Sean Ianchulev

and operations a trials and question. Esther, where we was industry wish look we very idea to hard if it's caution the how we to glaucoma study. of say, but there, are a think really person, program, thank and glaucoma when Again, you, have rearview enroll there to always been new what into unpredictability. a we whitespace. great can cautious trials, so seen a expect, any compare a is I this area of a - back we've don't into Ginger mirror good you new so is is I our therapeutic go MicroPine level it's so

we and did enrollment a studies, good there a we've for doing job really that it's when done and MicroPine have but best-in-class glaucoma a a new said, idea did phenomenal new for when Ginger field in ophthalmology. the before space progression and the myopic We that dry a being ballgame in in entire eye there. MicroStat That population, studies really was

So population about a light unmet being it's hands lot It's on And of of such evidence low-dose said, of that subjects. ATOMX controlled expect and the low-dose a their trial of laid we speak studies that evidence three XXX down a so in trying a of to are large really very and out currently, I and patients very, think reasonable need. to LAMP. groups a benefit the and huge atropine, effectiveness came especially lot randomized ATOMX, risk the best-in-class as collaborated for of the atropine. That get

be it's very going think don't we to So hard.

that will and because of drug, the But that be complete being well and the that I done know factoring received. large us, towards this the trial of big selection. that because a population, vast of think We therapeutic think work be in range that of in bit the enrollment, than giving how it lot optimistic we're already will said, I existing index XX of little we site we've we And unmet are is need for between because months also the XX. and that think that more a evidence a fact, and already and we're XX very what XX to we behaves

break plenty we I study operations XX bit and really sites, where cover think can between we're that more of looking XX the it landscape little that will to the we U.S. alone, anywhere to streamlined. and there's in enroll think

that hope I sure. I the really the don't we know answered question, note So cautionary for with

Esther Rajavelu

start lot presbyopia, thought of sort And prompted us what That's your a of then to can you that. process What's - No. this? detail, the appreciate about I at landscape on help kind maybe you there? of understand talk looking and

Sean Ianchulev

to really and the to my landscape, ability near, are well-being accommodate myself we of lens and the to It's we who the at read lot people and XX, wife the above, and happens losing it's impediment of we're of reading that reach and ability age grow our glasses. Okay. virtually the you - Well, is because first something really everybody why that really like when of lose over really as the stiffening a there's we need our old, XX to is people.

Allergan an The are the well. that well-established from very the would preservative the and compound, XX% been effect accommodation is cornea we know spray that pinhole programs for therapeutic digital Now we or to effect, focus an you the X very for creates is something it directly that. you single And to It extended read other through basically allows chippings. other - And maximum companies allows where of depth transient we pilocarpine and know for moving it the forward an now or in it's is be apply pupil. you of indication. when as X see of a which a it, that eliminate compound would has extracts also creates application on such approaches pilocarpine-based able way hour apply And be microdose a and dose. microdosing episodic to you perfect toxicity for technology the actually

fluid So we path working our we the our formulation ready. the efforts were with and our on also happy the were program also R&D piezo-dispersion that qualification and R&D, on piezo all in to - for learn technology. have compatibility that formulation successful our working to with And optimize that, from had and very

or X X because with studies pretty be this a like also III compound trials. because of II, a have be be be a will full similar all lot is are Phase And or program a working It this our MicroStat talking to so somebody now, are we episodic partner application. just we for very again, them acute about I and to MicroStat short-term to right hands well-known a think development going with the directly development. very will into on perfect we that would

a being too. that it's completely new Now said, whitespace

We what nothing and we potential. which which and new to huge So about applications for it's we know potential, take find market like. a approved there is new like is safety and presbyopia compounds,

Esther Rajavelu

then count you. John, is queue. hop the XXXX, this Can and for figure a And I quarter? trying John, just Got understand back then question maybe I for the you late did help the us here. last you, my in delta into will share but I'm out know fundraise to

John Gandolfo

Yes.

the with start table. me let So current tap

have that as are common shares XX,XXX,XXX. outstanding total today the we of So

now reflects right So you on outstanding, total quarter XX,XXX,XXX. number what but weighted XXXX see average for first number is P&L the the of the the

Operator

comes with question from Kaplan Matt line Your the next of Ladenburg.

Maria Barbera

for a questions. of couple have is This Matt. Maria I

first get trying the one to is The time in MicroStat, line right.

in XX you XXXX, stability started March means and so in be I'm think available I So your correct if that data will wrong, months March work me XXXX.

stability data, the filing? file quarter are Or second MDA, the delay that there that filing XXXX? meaning So is other could the you rate-limiting factors in to could step

Sean Ianchulev

Yes.

So me answer that. let

- unfortunately wanted linear limitation. we in here manufacturing. a proceeding are we the right, way You're fairly That's with

are need terms manufacturing and related You But for that this as sciences, positive this in parallel pretty have in - XX-month always small outlined. and externalities, is companies. significant - that part batch contracted manufacturing actually caveats which Lubrizol the you stability get Berkshire on go of not Hathaway III we, a of And you batches. is to confident as as are particle we're process. which the one there process, we NDA. is proceed company, activities would dependencies again, Phase way into to outsourced data MicroStat so And the of data also that that, to file spend a we wanted commit registration a could we before we before our and to in working And a

in we we said, while fairly linear the fully wait for study a generated. are The efforts the registration towards right is my are MicroPine is now, team being process outsourced are MicroProst for the - of batches. programs, and and The supporting parallel, registration the launch report turning clinical of MicroStat. activities that in the development So done. And the activities the

Maria Barbera

Great. Okay.

XXXX it fair like launch and would of that? to approval XXXX assume, say, something early end let's So be or

John Gandolfo

Yes, about it's right.

Sean Ianchulev

Yes.

quarter think mid-case will But but on less think time on turnaround side, or NDA on FDA would versus be plus also two that the a optimistic the depends be aggressive the depending I the I more yes, from optimistic. the that for it application. or

the basically the and formulation are We tracking provide updates And for very closely we will and more activities manufacturing anything stability fill the changes. you batches. if

Maria Barbera

Okay. I think anything meeting pre-NDA FDA, Or that provide hold And you to XXXX. with speaking of Meet that plan the FDA can Has your occurred? the was meeting there?

Sean Ianchulev

Yes. forthcoming. It's

Maria Barbera

And it or your said the product this get introductory to then I going at trying MicroTears time? both launch, the launch you better remarks link to Is be because that to Okay. expected for to think ready it's because of think in long take you that them to territory-wise with same OTC MicroStat. it's launched is the commercialization

Sean Ianchulev

MicroTears, I and the providing always additional artificial augments been second. for think mean it's an I the program sales tears MicroStat a by companion product. that force

potential force. put force cautious because of maximizing hit We a them MicroTears together. lot hip are to same effort and the And from launching sales the about a the really big makes and shooting it customer, very sales MicroStat sense of that without

MicroStat, the has of which on And so kind It respect. dependencies ancillary the the that program is FDA. tracks MicroTears from

is our dots commercially very with become device terms with year, of confirm think and it registered. are as register which there system, also validation yes, another of do which will would we alleviate And same that of we container nature in delivery MicroTears the the we significant will closure the associated value and time well new our think add to because because about level eliminates much any really MicroTears, and and the more little MicroTears. a delivery pretty we have connects So system. this time, it commercializable At new bit a looking doubts on

Maria Barbera

was week. the then the last don't you - - that introductory question know at if the presented miss but I when that you that you is of I first results last did Okay. your it of think beginning with the in Great. And remarks, my data treated I think regarding had which specific preliminary. you, primary again, present the Because that I the the already reported dilation, patients X-millimeter XX% in said endpoint?

detailed did presentation share the to more results don't that to provide or you any published at are now be going you want because So they something?

Sean Ianchulev

provide secondary did on granularity course Yes. bit ASCRS. well time at of as two I outcomes we the the the a in studies more mean little the

want review the all of that. sure that we to jeopardize want FDA discussions As do by make b, we a, as we revealing everything data; have publication the by and we know, we don't of also all to the first and

So the we we've data very can process. registration our as information relevant as more And publish technology. think also provide course, meaningful I provided we to we a complete of the and most FDA probably meaningful, lot it and

Operator

comes next with Yi from Wainwright. line our And H.C. question the of Chen

Yi Chen

the specialty going network My in eventually? to is have is there first plans company? and How update network the carry whether it MicroTears any on network same And distribution question the the MicroStat regarding much the both when to will company pharmacy cost place? is,

Sean Ianchulev

for Thank Yes. question. you your

weak faded. let and that coming very know to want you're you Just

is some this prescribed doctors, the purchased rather practices especially provides doing by MicroTears, also MicroStat company a the for They us - I and by Aerie significant now the this has the nonreimbursed really about that think company purchases, all for two very products. and other network I that from thing to be of developed ophthalmology. Michael came have to to capping who with really a and We veteran great are And products, this very customers. option amenable there efficient about wanted a history was question small makes decade-long which business, to Rowe, one nature. a that your and being than find it the first scalability understood, is I way to you of this are specialty is say pharmacy by

physicians aggregated are we offices. practices with today, in many most multispecialty As know,

scale through to So it us allows really the specialty pharmacy network. quickly

I I this option, we and it quarters on about still that details for we looking developed, think and over X are or will this be that seriously we Again, X call, in is on excited be launch. something into time will very the are finalized our that. so don't Again, discuss it. think being very next can

Yi Chen

My second is question on operating expenses.

So will that studies reasonable the the operating expect? and How Phase to start as III is MicroPine the XXXX? company it have expect you sorry, Phase we and then then MicroProst - expenses increasing III should III increase in MicroProst much Phase

John Gandolfo

current think I you is, So the is, not look if expense what necessarily. they're at rate linear the

completing So MicroStat they little they the the were - in were quarter, because were quarter and a higher we study. fourth first our

that I $X you this expect levels, increase probably - will XXXX million be year quarter come per will be addition be to magnitudely And the of over to XXXX into could but is perfectly quarter with we and get that not as the most current the per fourth honest. of the $XXX,XXX study. roughly quarter MicroPine with and this about MicroProst think that that the study will of - another be

Operator

[Operator Instructions].

comes Our line National Aschoff from with of next question the Securities. Jonathan

Jonathan Aschoff

the MicroStat? market you'd coming to year were least market a should is mean Or than heard that you MicroStat. be at with I be on XXXX next along that expect the to correctly thought MicroTears be launching rather it MicroTears of earlier year? still going ahead You Does I that in to saying we

Sean Ianchulev

at correct. are same We've on products, because and both them to planned efforts. companion better So sales of to the time launch and they our a want ROI we always have you're yes, -

the launch, and time MicroStat registration this So that MicroStat. process, will footsteps the the MicroTears the primary approval that and pipeline FDA alongside governs for the and that the product is goes in with lines follow through

So that's correct.

Operator

Thank Dr. now questions. remarks. I'm back you. the call I'll any for to Ianchulev turn over not closing showing And further

Sean Ianchulev

Thank hope and informative you. we you, the and that update appreciate everyone, I an attention. Thank was

Operator

Ladies and conclude program. the does this gentlemen,

disconnect. a day. You have may now great Everyone,

Eyenovia (EYEN) 14 May 192019 Q1 Earnings call transcript