EYEN - Earnings call transcript Q1 2021

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

Operator

Greetings, welcome to Eyenovia's First Quarter 2021 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note this call is being recorded. I will now turn the conference over to your host, Eric Ribner. ahead. go Please

Eric Ribner

as to months Sean and Rowe. conference quarter three everyone, XXXX. are Eyenovia's March quarter a as at Chief read announcing on today's Officer, report ended will first release, XXXX, ended which Chief John release the everyone the Financial for Good and press will this Gandolfo; and welcome with We Form afternoon, audio press earnings website press Eyenovia's company's eyenovia.com. Dr. also Medical be quarterly Chief call Officer XX, The release Officer, well XX, for today results report Eyenovia's quarterly webcast. available XXXX Eyenovia's Chief Executive Officer, Michael be filed afternoon, Eyenovia's encourage Operating and to XX-Q SEC. Ianchulev; Earlier With and financial Eyenovia's the March issued me Eyenovia on

date call of and – the parties, impact forward-looking and to differ trials. risks concern, submit Litigation the from company's initiation, business. applications of and will and The cost, yet candidates, for, under which we conference social to months that today the obtain discussing potential discussed global of In candidates related least impacted licensing our of FDA as opportunity today's distancing, information that obtain is Act. report or recent live and management qualified circumstances and adversely could results, legal licensees implied listeners evolving utility clinical operate, supply chain, the the to that risks, and progress, manufacturing, statements. over subject XX market or risks, call, could money obligation with to and said, forward-looking accurate on COVID-XX the resulting statements in except as our call ability clinical applicable through information statements these those ability provisions in next Eyenovia's of the contains raise maintain legislative of limiting for statements regulatory on implement, stated the Private our are broadcast, uncertainties of Securities may these our not in advantages this materially of call, this going those our products addition, our of timing will of approval of like including clinical acceptance markets and partners estimates markets additional required during for all webcast key candidates, release Dr. to including product design, our for of the for the conference to the by due also our economy as forward-looking no and regarding update by changes such regulatory the marketing to be of strategies or our results other the uncertainty Reform revise licensee trials by statements the fluctuations and Please approvals to, our enrollment covered approval. regulatory potential the potential legislature turn Actual undertakes call to call, capabilities time-sensitive XX, events note receive rate on We environment the and operations in financial to this These to to caution associated will product subsequent to on certain making Please and attract or maintain on a results light forward-looking be filings. on I'd our the impact – COVID-XX revenue our be press With the have May XXXX. which conference Dr. archived is fund is Safe product develop, and at reflect reference. investigational Harbor be timing, and for the trials degree securities this financial that in from a being COVID-XX pandemic, and most by number to in to be risks contained product website, annual note and potential detailed SEC its property any of our we ability ability company's our date and by Eyenovia risks This XX-K us in our Ianchulev? Form in licenses candidates, and candidates, intellectual and market and the Ianchulev. changes and for law. call after the commercialization, timely personnel, and retain products, including, third transactions, but filings, reliance – product our to future cautionary that only Sean ability which Eyenovia's volatility

Sean Ianchulev

Eric, and quarter would to conference date welcome our the PDUFA key review MydCombi MydCombi our to is approved, smart this quarterly confirmed combination since a Recall call. two update transition commercial XXXX as you, the a Thank FDA earnings that the with our Optejet. NDA. last microdose delivery that stage everyone applied be or has precision is system, ocular high highlight fixed first A October It XX unique to the us dilation. company. leading our also would mydriatic of therapeutic pupil medications first If

complete this potential patients exclusive If a hardening significant MydCombi order approaching lens March very will approval leading affects people commercial million line with alone. or in necessarily top in to life sciences causing during be lenses with the in to altogether. vision MicroLine product to EVERSANA, the of a the the our glasses in unlock conducted, contact Those sharing approval. agreement most results helping market rapidly provider by of approved, approved, will FDA see distribution program. is blurred the if soon And billion the used MydCombi pending are physical VISION-X commercially be our glasses for manage would we management data company. partners. situationally milestone completed alone. fulfillment shortly, inform nearly MicroLine, near industry, as coming to that intended improvement a is formulation we later in efficiently proprietary a that to quickly Presbyopia estimate our surgery. of readers, help opportunity companion the be or at U.S. in analogies eye, announced demand at vision the weeks. full oversee the how first presbyopia. on not glasses us age-related to VISION-X remedy enrollment service XXX important We data is anticipation The and We're results expecting the after to the the of shortly. common launching to replacement this Also anticipate quarter, results we elaborate Michael in anticipate the an our and will year, X VISION-X for pilocarpine this So and near we In we on process. study U.S. approximately of of

we serves that was has of the want Directors Michael, to last We and to renowned scientific the point, hospitals. Board. Sidney Chief Haller, join turn announced of Philadelphia, Endowed insights the the Thomas Eye call Needless call Ophthalmologist-in-Chief details advance Operating College ophthalmologist where that joined us, and Jefferson be Professor Hospital one more Julia on Haller our leading at addition Officer, is of significant to guidance as on Chair Tasman Michael at our that an working world’s Chair. Dr. to Dr. to parallel over Board to William and in leader, our and University She also at Department her retinal made Medical say, our has for programs. Haller Dr. pipeline. Before holds in At I believe of we our as she on Kimmel clinical comment month. very while currently current and the Wills pleased will turning Ophthalmology this educators. Michael? we're the and programs surgeons She's invaluable Rowe, physician I'll decided our

Michael Rowe

Thank Sean. you,

our fixed on with update medications combination today two an agents. dilation of Let's lead pupil mydriatic leading MydCombi, off or unique

the benefits now effective reliable application, dilation acuity, to new photophobia XXXX. agent accepted we meaningful XX, of by U.S. NDA provides the practitioner and diagnostic Phase X date than PDUFA subjects a with reporting supported pain. Food pupil with MIST-X, quick, our October a that weeks of reduced The potential MydCombi and has confirmed vision, the and patient. was drug few both As or two fewer ago, which studies, announced MydCombi site is and X% or and informed demonstrated visual Drug Administration blurred MIST-X the installation

current our time a time reported minimize results without can putting formulations. a a eyedrops no a On a use For are potential Also comfortable loudly help the potential option. those the to and doctors room costs. resonates the increasing decrease believe eyedropper. to MydCombi, less that mentioned, of is throughput be for to was in by very this staff compared that cross-contamination patients, nozzle, With less there something the just daily the we be that switching since MydCombi the to to protruding in patients, into can exam practitioner, And era. safety, and product reclaimed over in of patient patient comfortable studies. faster, spend COVID-XX as hour as This improved more there in for basis, increase different parts the clinical recess in of including far likely sting and touch conventional eye Optejet surface is the an

willing planned discomfort for better eye of benefits people side that is doctors be in The get drops. research these may encourage million performed exam. a annually a the and by areas MydCombi and plan themselves payback Instead, expand metropolitan care the from in diabetic be the professionals. we maximize we this there. to surgical alone. All to we efficiency comprehensive issues X every exams, quick MydCombi, our of traditional detail comprehensive on further resemble a able approach and to We estimate due address our some there dilations the to FDA to approximately are quarter, went large value. market drug year to XX estimate approval exam around this points, millions in annually eye will key XX% our be of and of of sales will a infrastructure. volume million ophthalmic translate plan expenses Market XX being practices comprehensive terms the an salesforce of $XXX create into address target more other eye total our launch to opportunity to high upon take salesforce not practices to the these related fail will effects may substantial initially Last MydCombi largest in undergo people million with people eyecare comprehensive just hope just U.S. top in and exam. XX volume recapping commercialization market having office-based able and mydriatic of corporate help patient with traditional for To suggests

and Another no savings in for managed approved, within and key costs the to six is aiming launch. substantial, means areas a is are to something infrastructure, EVERSANA MydCombi to ultimately to sales company ramp currently agreement not along doctor's the need weeks care with purchased about replacement, for prescription contracting, with of directly by track direct as do and we are MydCombi This formulary drug our so differentiator approval. launch no up means pharmaceutical that distribution agent purchase other have waiting that data If The practice. we time of diagnostic is no on.

presbyopia. pilocarpine us proprietary administration the competition. compound in factors is of apart eyestrain presbyopia, has reading to normal which at blurred a your hardening improving now via our with program vision We of MicroLine distances Presbyopia completed and eyes headaches. placebo-controlled which our future study, that vision our near recently for Turning in VISION-X been solutions enrollment to is well-validated announced whose blurred one and causes assessing from set efficacy age-related can non-preventable Optejet is treatment is that patients lens. the have we the the lead and the Pilocarpine vision for of the on

our U.S. as quick conventional top-line glasses. with how data a in happens population like MicroLine. inform reading presbyopia. opportunity overall to visual lead results been With of the a a as overdosed the potential the few unwanted has and for distance of will is mentioned, develop is VISION-X And plan old suffer Sean of century as study market acuity. the help to near part common Optejet, or remedy the VISION-X can people Nearly with the one-third endpoint often binocular minute MicroLine to and a reporting we relatively drug is to we in from effects. eye quickly side efficiently. study VISION-X anticipate conduct weeks. most not The technology corrected XXX take the droppers, address And that primary our I'd million

Within rely that these XXX believe impact younger on their million can on there population. people for has of glasses or whom be reading an people having quality temporarily uptake in will XX million this option a about significant We glasses life. on-demand significant a replace for to

market from Our the presbyopia be market in nearly research estimated X XXXX, the reports alone. potential billion December to U.S.

very are like Thank back are to programs call two the And with I'd pleased We to how these turn you. Sean. now progressing.

Sean Ianchulev

Thank you, Michael.

the having therapies and intended and than same at MicroPine less Korea. commercial benefit retinopathy time, and our that that treated South capital. the and of China we payments this Eyenovia, partnerships sales have loss. milestone-based reach, There are been milestone or treatment are we following For retinal those shown a the FDA for to the received MicroPine non-dilutive our clinical U.S. studies by Health myopia in development proprietary upfront no detachment we're Arctic providing result has and who you of myopia XX% when know XX and Vision reimbursed, have progressive while and are myopic in. in can you Canada, third been of – vision progression These To-date costs significantly more. program, out-licensed in approved extending if for with atropine potential potential to formulation in the in million more factored is currently Greater payments slow Bausch royalties

we these in pipeline additional as other part of And evaluate world. assessing in will strategy. We to opportunities, technology needs of expect unmet long-term as We're our out-licensing indications. additional address expansion Optejet the end, parts that continue believe an leverage such continue partnerships be important also growth the we ophthalmic to to large opportunities to can we

eye opportunities. Some examples each with glaucoma, include market and significant dry anti-infective anti-inflammatories,

We have front. apprised We you nothing forward that of in look keeping definitive do to to our progress share today.

development Of like described. would these the to as activities outsourcing call least such be course, opportunities the review I'd John beauty just the here at now that to to over funded financials. by is turn those partly John?

John Gandolfo

Thank you, Sean.

like to ended financial would the results months I the Now review XX, for March XXXX. three

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

and Vision For corresponding representing fee the the of reported first this quarter same to development quarter of license first of and XXXX, $X.X million for approximately Senju million the in XXXX, the payments company agreement of million an license of XXXX. for totaled revenue increase approximately of revenue from cost to our Arctic the $XXX,XXX. compares $X expenses XX.X%. Research approximately And $X.X period

operating in approximately increase XX.X%. quarter of $X.X for Total expenses G&A For were XXXX XXXX, the $XXX,XXX approximately first compared expenses Operating with total of the the million expenses This first same first quarter for approximately of million of compared XXXX compensation in approximately an XXXX of period expense. increase of the approximately represents quarter included million an XX.X%. XXXX. million $X.X expenses to of $X.X non-cash were quarter first $X.X of for stock the operating

with proceeds net sufficient cash $XX in As million the Valley company believe loan approximately our the of the excludes Silicon cash proceeds SVB credit cash approximately March and of XXXX, $XX.X million into balance We from third and initial figure this $X.X announced recently provide initial company's current million XXXX. was with resources XX, Bank. quarter the facility

prepared proceeds process commercial of and programs our And clinical Mydriasis of complete it product our to cash through advanced were This out and the statements. presbyopia, manufacturing NDA sufficient bring technology. current launch, Sean. for our over now turn will pilot dispenser inclusive I the our MydCombi, Our prepare MicroLine SVB resources our capabilities to financial concludes

Sean Ianchulev

quarter performance XX, NDA. key forward the summarize to and on today, PDUFA Thank to during look you, with our pleased we're we John. MydCombi In first period. To pertaining date subsequent very highlights our closing, October our

and expand our advance realized, for can data multibillion-dollar and to program now Arctic and We to meaningful Operator? we're positioned would are potential and regulatory questions. VISION-X milestones, prepared non-dilutive catalysts our use benefit regulatory our if well well the with development estimated We Phase in remarks. Health commercial, term. shareholders. the we call are concludes And licensing anticipate vision indication multiple in advancing very progressing and the achieve agreements We patients pipeline. near and continue development of year to the to for open believe presbyopia our X funding, like rapidly offer from and Bausch to That this

Operator

Thank you.

be question Partners. Yaffe with question-and-answer session. now comes a go Stoc*Doc from Please ahead. first will conducting Our [Operator We Instructions] Len

Len Yaffe

Allergan age, Thank you much. X sure you Allergan stabilizes, does was few show for group the cohort advantage by to was you the tell us study Thank at very if not five-year study that's your to an and XX age on at included roughly benefit And conferred age study? they on looked the then in patients decline X or much. focusing and cohort, the clinical think it that you to been pretty and more XX if make to looking I presbyopia in to very can FDA submitted tends XX given age difficult in you, group? increments And Phase you in does to that what breakdown potentially VISION-X it it that wondering you XX. XX. your could were comment I XX VISION-X, completely ages Phase in patient, to I'm the approval. quite significantly, And XX, between XX

Sean Ianchulev

be forward it. – we to the we in shortly I'll will Len, look and questions answer better to analyzing data, have detail more these thank once able Wow, think you. be which I That's

to of be First, back quality, established in the very pilocarpine, field. active, well into even and all with in us as not I field level And again, in many yet going though agents, are mention other in seen rigorously such it's presbyopia, fairly field. a conducted data to that our field have approaching to many just who that well want conducted which seem high step new too we're registration it are companies we and studies see we

completed, of of studies form, that correctly and that announced mentioned That really the actual informed formulation conducted I Phase said, studies. in believe least answer can their presented eyedropper and to-date, their a the they endpoint in is an we primary that Allergan one seen haven't being and I way. your has met the first seen, You have ones I pilocarpine haven't so in at really data question X more

point even are population companies between population we XX is approaching and accommodated their because on affected Allergan the other more analysis. results subgroup XX side. We another We population the between study, that and study. a and our severely that and or obviously in XX presbyopic wasn't included almost or population lose one presbyopia that exact the presbyopic is haven't We're bias seen in above bigger in the potential and seen Again, estimates is they range this too is more balanced slightly population nor more maybe of see five-year with hoping probably to have XX earlier can population a argue another completely.

of firsthand with the and led quite yet the for COVID are eyeglasses are the a how promote see settled are younger. and first whether being older little experienced There enrollment the we it that or to the enrollment is not looking XX patients a and are established That patients, bit impacted of preferential ones into that also really factor to they solutions. said, for presbyopia time Given breakdown. exact are those to that XX the

want question, come haven't a answer we to order think, a but in we'll neither all many see Michael, the I out hopefully Allergan well, us that talk we more we'll with bit more able do more? weeks, others anything really to nor data, comment able will and few about results So to give your that, little months, analysis. be other to companies, do that. you be give from too us that comparative seen And

Michael Rowe

quite think that I you. you Thank No, handled well.

Len Yaffe

Thank you very much.

Operator

comes Tim go Our from next question with ahead. Chiang Northland. Please

Tim Chiang

bit is VISION-X. that that tweaks there's going Phase you slight designed? the be I Sean, was thought you about guys the haven't to in VISION-X, the study. already about I talk study how to any seen the if similar second be you to to Thanks. thought noticed sort second I'm VISION-X Great. Have study. X from the guys study be pivotal little but wondering to a results going I press very planning study, release, know for of the going

Sean Ianchulev

Well, question. good Yes. that's a

of make eliminate for dose and definitely we go of faster. study, and maybe because do I it population be but doses. and doesn't design about more it another Why the anecdotal little parallel, First, the And way we a selection with very it more Why maybe before real able Phase if a them one Because with one around, Xs, registration you can it's did similar that keep may and but who VISION-X, almost found that we actually we I question. a VISION-X, ranging them one results we be very efficient, and to a modify at – a plunge will VISION-X a of and it's more look results be VISION-X we development. dose a the we trial I dose the them? find inform we data the conservative really definitely a same bit a lot or not to call full-dose we a all we the time? in that efficient do look be to have that from qualified that to we one at we if Phase we rigorous see of just would the data of Also in it able think may just wanted prudent from also could positive, would run bit design given maybe for dearth clinical both ask not of is at make thought like it all it one or second X/X

development, I know you tend it's empiric data. never – at clinical to to good always in look So

I I but we'll and through get you how path we're going be to our VISION-X. forward my will data tend can the able So it, and obtain to be find to to quickly team the tell exactly advisors modify able best with

Tim Chiang

Okay. Thanks, Sean. That's helpful.

Sean Ianchulev

Okay.

Operator

[Operator question Instructions] from Kaplan Please Ladenburg go next Matt with Our comes Thalmann. ahead.

Matt Kaplan

Hi, guys. the Thanks question. good afternoon for taking

bit terms looking to should Just on up that wanted point, in VISION-X a for terms of follow Len’s of question the top little in in end achieving terms line what primary and be be should reaching end we'd the of point. that exciting results

Sean Ianchulev

not end And a the and a realistic primary I point And three non-specific vision question near. secondary gain DMA, points it's good I multiple patients. I also most of it's across actually look endpoint, only that don't to some is indications, bit at macular we it's the Yeah, too. a at as point degeneration, it's of look would lines a would think that at such in I for primary The the ophthalmology Matt. very necessarily matters standard use think what end

they what and way required patients think necessarily their ophthalmology. to their tablet I gain see is a three be at that registration lines for but XX don't or is for to to standardized want their pretty it's smartphone, actually able have computer, centimeters,

also these therapeutic vision. really be we'll we'll that again, patients. So the other two looking gainers, we at for benefit at things are be And inform line also important looking will parts – the that intermediate have overall that are is

needed specifically would want will of that you a has to done patients, and will Michael it two and see quick and the because to ton lot quickly. this I'll to on-demand, Now, is let seems what be which matters treatment we action him but in we've market want on three of four. comes it answer a done great, Obviously as close a even And effect maybe side research this fairly more possible. an endpoint therapy. be on-demand a of expect or be we will treatment But to to go is it episodic as hours, off our again, the

that? Michael, anything to comment you So do more want to

Michael Rowe

Matt. Yeah, and you hi Sean, thank

side I think to profile. the the other thing is pay effect attention I would

of some miotics effects is that the One minimize the the efficacy we're brow the on thesis that issue out and could side and and really know a contracts and XX% product. eye the market we can circulation have comes that gets of damper has We that with know of seeing muscle. brow this an ache major get and pilocarpine a probably if if from behind you local microdosing a from acceptance that brow of into ache of or anybody put research seen all

eyedrops So would level I low well. the us of be profile differentiate very as with which a then a looking from effect side ache, for brow would

Sean Ianchulev

Thank you.

Matt Kaplan

taking helpful. added Thank That's you for the questions the and detail.

Michael Rowe

Thank you, Matt.

Operator

Sean for I will now over closing like to floor to remarks. turn the

Sean Ianchulev

all. you thank Well,

on milestones. good you thank us I you we that And and everybody hope think to again upcoming for forward communicating afternoon. with look want our joining with a I to has

Operator

today's This concludes teleconference.

may for participation. You time your you and thank this your disconnect lines at

Eyenovia (EYEN) 13 May 212021 Q1 Earnings call transcript