EYEN - Earnings call 3 2023

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Operator

Good day, ladies and gentlemen, and welcome to Eyenovia's Third Quarter of 2023 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded.

I will now turn the call over to [ Glenn Gorman ]. Please go ahead, sir.

Unknown Executive

Thank you, Judith. everybody, Audio Third Webcast. welcome, Conference XXXX and and Call afternoon, to Quarter Eyenovia's Earnings Good Chief Kern. With Officer, Financial and Michael today Rowe, Officer, me are Chief Officer; Eyenovia's John Chief Executive Operating Bren Gandolfo; for This afternoon, press months a we September XXXX. the financial XX, release ended X announcing issued results XX, press SEC to will our ended as September and XXXX, as which Eyenovia's tomorrow, for quarterly Form encourage everybody release XX-Q quarter We report filed the the with be November read today's filed recently well on Form most XX, XX-K.

our report The at release and company's press are annual also available on website www.eyenovia.com.

FDA this product, archived the also webcast on making there product some the harbor of Litigation concepts addition, we on yet that caution certain call that the forward-looking the information be of listeners reference. call today Reform the future approval. call, discussed will note safe note will be and under Securities receive Eyenovia's management Private Please candidates, and In We is have for provision on covered which conference Please statements. discussing company's that to Act. be call, being is today's website during will

forward-looking securities reflect call, may the or XX, in conference differ of XX-K. Eyenovia to to detail company's date required XXXX. statements Form except by the or revise update those from time-sensitive obligation forward-looking statements is more contains conference in as to statements a with by events on these subject be are our this live report This which due Actual stated described this business. risks undertakes could information risks that results to November are associated applicable broadcast, materially as uncertainties after forward-looking only annual any and law. date circumstances implied of accurate the no call These of number of or

I'd Executive that Michael? the like call Chief Eyenovia's to Officer. to Mike with Rowe, turn said, And over

Michael Rowe

in and potential to of launch everyone, the I'm well financial setting and own ], Eyenovia results to progress eye and glaucoma highly conference Thank monetize call. and a [ our of this success. welcome, had development the our results both XXXX and we as our of targeted the future third Mydcombi, you. future excited Glenn terms our quarter, plans tangible quarter to prepare afternoon for third leverage launch approval partnerships stage as our beyond APXXXXX for Optejet share in as programs. dry technology productive and

our for Mydcombi commercial start Let's preparations the with launch.

X first be familiar Optejet. only For those FDA-approved and of platform spray the fixed and it's with first combination dilation who might drugs, the not Mydcombi, using you the of popular electromechanical pupil

at we were that by our approved finished and begun to month, manufacturing. this receive Earlier Production FDA commercial coastline, to has was manufacturer, already Mydcombi expect warehouse Coastline for we into product the XXXX. our announce January contract thrilled International in

The course program. offered and our Health with hands-on manufacturing are during Ophthalmology's was provided of the sponsored also education and we in use technology prepare experience and the technology. XXst Allied dispensing annual we product ophthalmic to and on addition the to raise awareness the In Commission Mydcombi, the market about the week, course continuing Mydcombi. Personnel Joint Optejet International technicians Last continuing to Optejet

blindness. load. Meeting, unmet believe demonstrating data the significant of Last high over-the-counter be daily in presented we pulled practice. demonstrated serious drugstore chains sterility. In a to Optejet's a major use, the product even news and have also Optometry far and due about to conditions many all off eye from the a Annual that significant the sterility recent maintain to and risk the would contaminated requests actual We addresses Optejet of the and microbial This to retailers need given American leads the the exhibition collected device load Academy their that of even product technology drops the in timely, ability ability at shelves American presentation who exposed when Academy booth microbial of maintain its Ophthalmology at doctors exposed the month, being particularly eye exceed infection was to

ability We the of extended validating the process of are now in without time. deliver an period preservatives Optejet's topical medication to for

commercial share $XXX meetings technicians continue to great Our ophthalmologists, and pupil activities for and positions a customer to reaction good for a we have avenue take mydcombi.com. Mydcombi at these next market us U.S. market feel early year. optometrists dilation coming product next-generation Mydcombi ordering our to are valued at appear device. and More The to broader years, we move professional including and approximately that portion unique the on a launch this to socializing shortly of of well current we will over instructions been is million, poised information, when especially

intended forward In to the early in APPXXXXX APPXXXXX exclusive twice significantly steroid is this is with a with pain. We the to titration, X Mydcombi a profile. treatments. solution. desirable than March daily XXXX, highly convenient times and potent under sell announced a existing approval be the FDA dosing for not revenue distribute titration It more we almost FDA without only for Pharmaceuticals we recently review or is product which an and generating postocular efficacy agreement alternatives, Unlike regimens potential ophthalmic rights dosed looking with U.S. pipionate but Formosa us, for safety surgery APPXXXXX, are to acquire day of XXXX. currently to is and anticipate clobebazole inflammation all

sales procedures APPXXXXX recovery all This market for the a potentially to significant surgical offices surgeries ocular during XX-person centers. is approximately process. and expect us, annually add optometry and we leverage force in and our utilized planned are to almost There X these significant and both Mydcombi value ophthalmology of steroids topical for million and

near-term the the opportunity. for Optejet, potential has to including indications multibillion-dollar addition providing a In eye, revenue, market additional dry APPXXXXX in

Formosa to determine post-surgical of the efficient path look to most product. for March for forward approval and indication on working FDA we year, potential next the this new the Following the X with forward

and and shareholders, our specifically benefit continue brief that provide updates these in I'll opportunities a and We regulatory believe company additional will to glaucoma appropriate. dry explore we with now. update we partnering you when provide developments on eye, our will

past, Optejet in research to small most experience. patients have that own topical that design options. among that eliminates head would its always ergonomic and than be handling populations they difficult with in use consumers believed the bottles due market using the And you eye medication reported and the drops in use the eyedropper was shared to that we ways We available our need currently easier for to healthy many

an eye, in product eye not labeling our we formulary classes a dry a with difference meeting demonstrate would drop our Optejet provide to to or only agency covers option language in FDA be with either coverage how forward mind, as such believe can they for in recently provide only held confirm as there products help to eye that is who clinical time product. the this or ask We successful products would a benefit, the have evidence the We lead difficulty as to challenging such or have Optejet drops. in the this that glaucoma path labeling With compared benefit. safety include as with the might a for patients select we eye to of of cannot future reliably that patients but prescribers use who long better efficacy drops we products

use. device, presbyopia. Apersure, with improvement our Lomb to that our for is Apersure and in Now our the in Arctic use These associated Bausch with more will + their has of myopia therapeutic City which we XXXX. for at turning designed pilocarpine-based be for currently facility, manufacturing the to optimized on-demand near the which proprietary Vision advanced with manufactured our prioritizing X in-home Gen vision in partners X pediatric temporary been topical Optejet candidate are Gen Redwood beginning device studies supply developing being is product

reminder, a for and for partners facility. income paid our a are portion helps that cover As our we of the reducing overhead that by supply,

the to for drop by Because We on of quarter treatments manufacture evidenced we as launch impact currently will Apersure of do the have the change believe XXXX. of not into first of as materially continues timing eventual the mature batches of and Apersure this performance registration only moved the eye date market. this, the presbyopia market to the evolve the topical for presbyopia

we update, corporate Board of our Committee. a the of appointment Mr. Michael Independent pleased Audit for to Chair [ of to ] are an Director and Finally, announce Directors our Geller as

for more XX of and Madison Boys New the Association Readers leadership Nielsen. with year financial as Boards University of and former than years of and Stock Mike is and Cypress Mike previously Board member the on ADT currently to Corporation, Officer Girls Supervisory the Financial & Digest senior a next, Euronext Creek Board on Renewables of served Exchange Square us Delaware. Chief experience, York A.C. comes including Club

excited to Mike to Bren Kern, are look this and our to forward turn board call his We have insights. Operating over and Officer, update. the like our I'd At for point, guidance Chief to manufacturing on Bren?

Bren Kern

Michael. you, Thank

configuration significant third and our Gen continue Apersure. capabilities Optejet to bases in Mydcombi, we the in build platform support made X to have progress We as the up manufacturing quarter our registration for

of commenced support of the are support As use launch. of product manufacturing in commercial of the Coastline Coastline launch XXXX. FDA the vital that International site Michael delighted Mydcombi the Mydcombi in manufacturing quarter to already we always the mentioned, commercial approved additional has first of

As additional with of date under XXXX. site our is FDA with Redwood in for as the commercial an a City PDUFA manufacturing currently review Mydcombi February facility

finish both batches the working also and of is Apersure. facility qualifying and X City Redwood MicroPine for our clinical line for fill Gen Our trials towards registration our

we the initiation of are of the delivery registration for batches aperture and batches of quarter our mentioned, Michael in As a partners first XXXX. targeting

Additionally, to manufacturing. make progress ] and continues facility base renal in establishing significant injector our [

and end installed before Recall, of indicated team been Since execution the including generating protocols, commencement last equipment. in of optimizing year. the operation targeting the the the manufacturing we call, has of we manufacturing had we our equipment are the protocol qualification that then, earnings

be a make our to meet as Chief over demand clinical products the John? Officer, that for the capacity. in in Mydcombi provide I significant progress would call to anticipated increasing John our positioned update. other continue to to as Financial turn remain Optejet to manufacturing well for confident We financial I Gandolfo, we'll like now the well developments.

John Gandolfo

Bren. you, Thank

loss share $X.XX loss of of or net quarter $X.X for $X.X XXXX, million share quarter or million $X.XX net the third of the per a approximately was XXXX. compared For to third approximately per

includes with or trial devices, were to shipment approximately clinical which The third licensee. nonrecurring found a after XXXX of certain associated expenses defective replacement $XXX,XXX to be of Gen-X quarter of the rework

XXXX of to and + Lomb $X.X replacement of compared totaled Bausch $X.X or of the impact XXXX. for of rework the third Research any is quarter have approximately expected study. timing expenses quarter The as not enrollment third the on development to for million million

For to of the of expenses third for operating expenses approximately quarter quarter million G&A of XXXX. of compared third $X.X for were quarter million third quarter $X.X $X.X million XXXX, Total compared the third XXXX the million approximately $X.X to were the XXXX. for

the were to and cash December As XX, cash as XXXX, million of company's September equivalents of million $XX.X $XX.X compared XX, approximately XXXX.

a Bausch brief payment on update the from on and development trial to division in receivables have X an CHAPERONE of Arctic partners with products we in the XXXX. MicroPine, from our MicroPine III that ] the for $X.X China $XXX,XXX all Lomb of myopia pediatric in milestone balance we addition our approximately Bausch Health Vision revenues, for Phase now ongoing our For progression. first of [ enroll cash South product licensing + formulation the of quarter and million existing I'll and addition, U.S. in to for of the XXXX, is a and of of licensing we program continuing anticipate atropine our the September update in XX, Canada license as approximately reduction above, expect proprietary our provide in Korea. noted

retinopathy myopia and therapies and shown been vision indication, if can has to in loss. untreated, are detachment, currently retinal for drug studies clinical result left FDA-approved in by XX% There slow progression It myopic this this no or more.

Arctic opportunity a with over MicroPine, the funding and a and source a for covers covers significant term. Our and myopia. be milestones. royalties in Mydcombi in nondelivery MicroLine of Korea, If to MicroPine development MicroPine provides Vision company pediatric particular, could long sales addition Greater China significant for our in agreement South approved, China and is

well the upon to with our license an date, both approved $XX the expenses also have years. is our To potential and license royalties. in in approximately If million generated are and milestones sales commercialization, Eyenovia million agreements development net fees, and additional earn to reimbursable on products next license $XX X over significant

additional leverage to address we we will our indications. in potential to quarter pharmaceuticals. unmet similar our performance the APPXXXXX technology postsurgical We today, are are agreement, ophthalmic assess third promos pain ocular of needs continue continuing exclusive in pleased very And expansion opportunities Optejet of as XXXX. with pipeline for conclusion, most our key commercial to acquired the to In rights inflammation a potential U.S. to highlights we to summarize large treatment from

We capabilities online XXXX and and development of production in a our to to as production in questions. targeted Mydcombi City August build a well And continue manufacturing advance agreements with Gen + significant we're continues the to achieved potential carry our first early out would X sale We Redwood Optejet Virgin Operator? remarks. our and prepared commercial continuing the to additional out call our now well production to facility our Mydcombi sales as coastline support for manufacturing to come progressing royalties. on are launch. regulatory and anticipated This for like Bausch licensing Arctic with avenue promising concludes now a XXXX. milestones and open remain Lomb to

Operator

now we question-and-answer Ladies gentlemen, Instructions] a session. sir. [Operator Thank will be and you, conducting

Lugo Our William Blair. of comes from first Tim question

Unknown Analyst

This on for is Tim. John

any So clinic getting dry trial a could to study disease? on you the any if early factors give into forward? was And thoughts moving remaining any XXXXX just if the wondering design are the indication. PDUFA for us I you you as could follow-up, for on you color provide what have waiting just wondering perform Or gating eye

Michael Rowe

are We is the that and PDUFA can file for for done, we reference all a lot saves information preclinical because waiting that time. once then of the safety us of

with product, Phase indication studies -- go dry So initial the FDA. eye. III be Phase relatively acute We've X would spoken in with directly be into could the would would the It we because idea be short-term the III.

eye used a because at common do the So adjunct current issue. this would products be as for flare-ups, job particularly good which the dry an is for example, don't solving

would waiting want discussions. had the the be, design and approved at the we've to So We we forward, because go the approval would for to drug. what know this reference point we're

Operator

of Thalmann. question Matt next comes Ladenburg from Our Kaplan

Raymond Wu

the Raymond progress. is This for Matt. in all Congrats on

is force just helpful. be Just the color for and state wanted launch perhaps more Any near licenses, it additional revenue in Mydcombi parts one was as about to ask sales the drivers moving I rollout? question. wondering, I have would term. follow-up And

Michael Rowe

calling. The state are for Thanks into falling place. licenses Sure.

is So point, at this it's manufacturing, which underway.

warehouse need going been The So force have we to get the sales product for January. product the remainder in They're now actually time available. and that's the to the when into X the is force, hired. leaders hire sales of

end the everything and So sales expect it, I is at point, moving this anticipate the at we way first would January. of would

Raymond Wu

efficacy, Gen And drops? Yes. I over is clinical the see that. prepared X remarks, mentioned that in eye superiority guess mentioned noninferiority FDA or I you the the more device,

Michael Rowe

safety of use that eye Optejet an X/X or conventional the the example, example, X/X delivers dose, an I'll example. Well, you and for I'll as know drops. give We

drinking you because beta you the rate use beta it eye that side because example, take by blockers beats beta So blocker is an up to drop, eye. an you're systemic and or going effect as minute slows majority end if a actually the if blocker per of as X a you're in literature, overdosing heart your this X the as

differentiate that because have it safety product. If is that up the end significantly show that don't Optejet, a would be label thing less that to able and That's getting impact, the the you lower we could kind likely of in you have will that use you you the available are dose. to impact systemically

Operator

of comes Len Partners. next Yaffe Our Stoc*Doc question from

Leonard Yaffe

how and versus And you about have the XDR [ the a market. total dry eye a ] of drug eye it to like be initially, eye big you'll the wondering, market discuss in be you it be seems was seeming about much you over-the-counter market? this the RESTASIS a drops? perfect you acute application the I dry Gen very to is how data more segment, Optejet? use of was bond. wanted that? that to of ] ask How expand the I the device, question APPXX the in excited very could you And is would extent available And that much I of U.S., given Could the in potentially think X in put talk do size it [ Optejet you'd that competing that's mentioned drug have dry large to because

Michael Rowe

to I easier me why I'll steal about we opportunity. ending from now that back to let to drop. and tremendous start a when Optejet from I'm talk the APXX And go think think it's eye an And Optejet, bond differentiating FDA We going say. it's on, with to the

with a when that of sensitive issues is called are to can is that increase, who steroids transient them IOP which as have see extended who One use you period intraocular which you want in historically, class the an patients time an pressure for a glaucoma. spike, don't cause like something patients of

is FDA concerned about the that. very So

], same drug. have XXX, we patient see of without is clogetazole formulation you population in in the in we X would the general saw clinical out [ Now trials, that the as basically which only

the to delivering still and dose, Optejet to is dry eye dosing, particularly less, think X/X these begin should pain But IOP drug if a would dry the is benefit for this with. the even don't which related eye we good to it are additional relief. using see because while because of be getting inflammation a you that see spikes benefit is IOP X/X the So you you're spike the

to additional want the put we that it benefit. get Optejet to why that's So into

know using still you're on on RESTASIS market for And that's not opportunity enough. are or many of who artificial cyclosporine or problems. lifitegrast, As and you for having tears you're still that, the people

getting this and a too to product, need So you be much those would times ocular calm for little use would surface. a XX it's you for that where bit weeks approved, if down just the something

other In and compete them addition terms to with to it there. the really market doesn't There of used out from It's in millions size, millions patients of drugs. time. time are

and easily really we opportunity that APXX a have with multibillion-dollar special Thank you. bond. could we drug, the for this is something right So be think

Leonard Yaffe

so on when or post could secondly, the ready be And that, either video much spending by that the like and could especially seems progressive would given the be texting comment market, you very on for younger Arctic their It it's cell drug folks pandemic either time MicroPine of Okay. a complete studies phones for filing so market. incidence Bausch or is playing games myopia increasing. large

Michael Rowe

can't tell studies. of like in you I can own previous either for XXXX. companies speak their in they're they know conversations, Yes. I as those that would enrollment I their finish to operating that

after the to which So it's assuming an that, the years endpoint take case, that's XXXX. end efficacy would to of X you

would of any be So XXXX. I think kind filing in probably .

Leonard Yaffe

you Great. after name like refer it with my little as a And it. to CRP bond, take when I'll

you. So [ Thank fair enough ].

Operator

Thank gentlemen, we now the Rowe will of session. question-and-answer closing his remarks. end the reached hand you. over Ladies I and have for to Michael

Michael Rowe

all Thank today, us you joining for you, concludes that today's and call. operator, thank of and

to momentum. far, year very XXXX had pleased with have close out with We are are and strong we so excited the we

April you thank look fiscal joining of our year. in again us. year March forward or update So to for We next full

Operator

lines. concludes today's and event. joining for now disconnect and us, Ladies that may you gentlemen, your you. Thank Thank you

Eyenovia (EYEN) 13 Nov 232023 Q3 Earnings call transcript