EYEN - Earnings call transcript Q2 2022

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Operator

Ladies and gentlemen, greetings and welcome to the Eyenovia Second Quarter 2022 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I will now turn the conference over to Eric Ribner of LifeSci Advisors. Please go ahead, sir.

Eric Ribner

Thanks very much and good afternoon and welcome to Eyenovia’s second quarter 2022 earnings conference call and audio webcast. Eyenovia’s are today me Chairman, Dr. With Chief Officer, John Ianchulev; Executive Officer, Financial Chief and Rowe; Gandolfo. Michael Sean This afternoon, Eyenovia for issued a press release months June the announcing ended XX, XXXX. X financial results as to and recently today’s Form everyone our for ended filed most which year filed XX, the Eyenovia’s March with encourage We the XX-K press release SEC report well read on XXXX was December XX-Q. as XX, XXXX website and annual report also at The www.eyenovia.com. Eyenovia’s company’s release press available are on

by Chairman that to the like except of as Board of over the Dr. Actual is turn a Safe statements to management materially call, time-sensitive applicable information call to Directors. required will XX-K Sean? accurate described have could conference annual discussing this report is In on subject revise call, live This contains webcast uncertainties the no for call Securities Eyenovia’s through and of the reference. events XX-Q. Please August this and that caution this date call addition, risks Sean are candidates company’s on yet to be website date company’s update obligation being this conference statements. to or broadcast, Eyenovia reflect be of FDA Litigation Eyenovia’s detail from With undertakes to discussed conference associated approval. on Ianchulev, most the We forward-looking of only stated statements we said, under law. implied also in be forward-looking future Harbor of with call securities risks which after of and are Form forward-looking which number the business. Reform receive results listeners investigational products the XX, more making Private by Act. will These in forward-looking there note our today recently covered these or archived statements to any the information during today’s due I’d that XXXX. those or Please filed note, call, may differ circumstances will be provisions as certain

Sean Ianchulev

also given candidates Board most the operations none search the for and for Rowe. than as identified this conducted comments our handing over that CEO, welcome, before Call. The who from Michael both Medical down appointment same XXXX where the Quarter Officer, stepping my brief I to a the the interviews. I very set consultant Officer Chairman to skill day, I'll At June, This Conference of agreed everyone, CEO several Michael to Eric to you, medical retained keep previously we moment and end a is an morning qualified a match bringing the Eyenovia's Chief comprehensive time, be Michael, Thank call Chief Second for search the Board At served conducted however, Financial announced our commercialization transitioning significant company. candidate. ensures a would Rowe, firm We while at expertise update. today. the require role. In to better were continuity, industry diverse ophthalmic CEO that and new a roles the and while we stand the serving the of potential now executive the of right broad critical and as Board, as company Operating and that Results time

we MicroLine in and in estimate regulatory for to Arctic over spun us stage At be presbyopia form time and agreements if in new a our up a will was in Together, out the brokering alone. the other respective the of could Bausch Bausch instrumental same was provide will which XXXX what these one the our NDA development of of our be This the market with Michael Health second be that non-dilutive milestones U.S. sources quarter, see Lomb, multibillion in fourth company. also commercial Vision. to of business Phase III presbyopia & sight care be us into eye study, application to transitioning wrap significant sales collaborations for products with in royalties. time, VISION-X we're funding line input dollar MydCombi approved, territories. the and are opportunities agreements resubmitting of We and we drug additional potential about giving

with This baton Given board, a here, we Optejet therapeutic launch voted his cement to will well. has to transition place and role, time this that well to of by assuming and of new provides the we board to able be expand therapies and much And with brings specific and the top in our Ram our our I'd experience. Chairman, significant of towards forward for Eyenovia. to I and milestones Michael medical new only to Each our the will also add where the as I to it technology month help position rapidly quality of place CEO development, long-term Board clinical ophthalmology. innovation of we approaching. look rounds future the served its our a over to of have expertise not benefit I commercialization for This and growth. us care through device. our With long-term world-class exciting work patients team time when in have involved Directors a my leadership a at areas will added is ophthalmic success. of Ellen I while This cross-functional record best additional leadership, clinical the announced across believe exciting to point, Michael's also Board believe very goals the technology, Eyenovia with we That as to we in regulatory work and what as new topical but be team the last the standard physicians and pass to member, especially and continue remaining experience, Board Strahlman track as have technology Board to Michael to of Remaining topic we with them a be this shepherd out to as validation these shareholders Board working entire directors decades Palanki company agreed Ram Directors. join and Dr. phase on strong as Michael. At we like Ellen guide

Michael Rowe

for that Sean, in for company joining would and my these I Eyenovia’s take you thanks words. and Board our to for moving in I’m we Thank new positive call like I’m through me thank next for you and you, enjoy. responsibilities for our to forward in on chapter kind this eager everyone excited afternoon. sustaining currently confidence the this that the the momentum showing And appointments. evolution the are

let’s So first begin an candidate mydriasis with on MydCombi. update our investigational

keep to test study, ongoing ability is the The completing device that the very validation stability, the by a included: studies safety all microbial was demonstrated very, when and microbes of to cleaning successfully. which completed X a to device users tests of required follow are were of that drug challenge nearly close and the reclassified MydCombi previously fourth ability human the factor from study. FDA electronic entering instructions; a We of X complete. announced assessing real-time Those the device; is to Optejet We combination. the drug study Optejet

supply delays and results have high-technology most experience later those this been did expect quarter. resolved. have We chain that impacted modest We now manufacturers

X-month if guidance. assuming result, NDA time a anticipated line the the we line, anticipate prior first are MydCombi plans year. quarter a are time this regulatory fourth during now from our approved this we As launch resubmitting half making for and review next And precision of unchanged the of in year. a is launch our Reiterating period

programs capabilities the Facility MicroLine several we operational. our Valley-based City, process primarily finishing from Optejet Optejet loading, operations, we before, facility in To our be that strategically MicroPine. device requirements the manufacturing believe drug new and we invested product The work of including we manufacturing capacity announced time manufacturing near said are ongoing meeting the validation partners, capable is may this our distribution. streamline and effort benefit the suppliers is state-of-the-art for new our Redwood of future, used both clinical fully new ensure of have review and recently enrolment and our facility supply and complements that and Silicon we As today potentially contract for existing gained in will in packaging and to relationships. now located that California, this prior other

as We industry research Bren Senior Vice of medical veteran, his Bren entities Manufacturing Kern, President manufacturing transition from organizations. career helping of has the commercial into scaled companies and spent Operations. also development announced hiring technology

to brings commercial and get-it-done stage we a approvals Over XX Eyenovia optimization, manufacturing set years, we solutions make skill worldwide. has manufacturing ideal important as regulatory past the believe and attitude led prepare We to Bren transition the product established GMP-compliant to the that need company. and he supported

to the move and our presbyopia. people in a for of let’s resources and Print near temporary United therapy have pay pilocarpine This Microdose an for Now MicroLine, improvement cash XX the ages addressable wore Array million alone is with representing associated XX in glasses the vision the over never market States proprietary product. between who XX otherwise

nicely. Our VISION-X, second Phase III progressing is study,

reminder, X% print As VISION-X evaluating versus trial a is a double-masked pilocarpine placebo. superiority multi-array

consequence we, workspace slightly out line to of pharmacological current market, later X gives approaching by capture while as of in is we a well market, believe Today, This benefits us currently employment as the of there This office create helping a subjects rates get technology. we and enrolment our Conventional the many enjoy. our of the in companies, drops a a of quarter. for is it we headache. Optejet VUITY. on top headache XXX saw of this And as and market low close visits. Among this significant anticipate In to But this effect is data rate side the are of required common full patients. found currently available is are that achieving VISION-X, very share high potential time into can We challenging our the line. target of brow their we and the leveraging treatment we rate Allergan’s guidance enrolment confidence low the of people is of XX% original a cause pilocarpine. headache to than pilocarpine other about ache, these study can this

less X% trial. to reduced rate this than saw we in Optejet, VISION-X our the With

we of far, so same profile the VISION-X. are And out coming seeing

preservatives the to to overexposure to administer In used is by ophthalmic traditional neater demand caused on be eye delivery dispenser from designed Optejet adverse preservatives. the sterility events preservatives ocular Over life. toxicity stresses these to less ensure far product can to shelf easier Topical help addition, through with this is and medications time, MicroLine of and drops. its typically to and contain increase lead the due the to than

conducted in avoiding unpreserved as the conducted have that ocular University last quarter delivered we and stress reduce the potentially with that such drugs, studies, these the have with We more discussed drugs one which adverse Optejet Tufts long-term events. demonstrated collaboration like preserved act

a We eye will improve droppers. indicating XX% traditional have in agreed patients give based among the great drug eye eye reasons the significant behind bottles use. of X this call much now that that doctor’s consumers research the delivery the conviction onto consumers, potentially process regularly be them This to our very vials, a to the last also In and in market. our have Financial or medication Optejet XX% relative address more deal much research of medication the a our body update. of eye handling give on to for Optejet Similarly, with and that market for would financial ophthalmic I strong tilting statement conducted who the for significant consumer too improve taking of those would doctors. patients us, that the totality drops their leading Officer, to patients interest over John dispensing and or felt a turn medications. recent weeks, control of have issues provide Optejet stated over that was conducted medication. can we prescribers head like the Optejet strong the drop prescribers, by The others were Optejet compiled most get eye ability with patients to the belief The result of the John? differentiator over research the would solutions strong independence the Gandolfo, Chief demand the use to that like us on

John Gandolfo

Thank you, Michael.

on the XXXX the reported period or This $X.X outstanding. $X.X million for we quarter of approximately share, million, of XXXX, approximately for For the decrease of outstanding. $X.X quarter and in share, of on per compares quarter to million,, the Research second net XX.X expenses $X.X development of XX.X second $X.XX million for net per $X.XX second a approximately approximately approximately XXXX. And compares weighted weighted million approximately to average of shares X.X%. loss average this million a or XXXX, totalled loss approximately same shares

approximately Total the million of For quarter expenses operating administrative and compared XXXX, quarter for the an the for were approximately XX%. expenses $X.X $X.X increase second million compared second $X.X same of total million approximately second period XX.X%. expenses of were represents to with of XXXX, million increase approximately of in XXXX. This quarter $X XXXX of approximately an for operating general the

million cash. was XX, As cash the restricted of million XXXX, approximately includes balance $XX.X company's June and restricted of unrestricted which $X.X

is licensing in for China Arctic October our to open part as the MicroPine license a worth Vision original for will & U.S. became Bausch It agreement was spun company Health Korea. I South the and X with Lomb, call and of was that Health, our of Canada XXXX early Lomb on that separate our that business we noting U.S. while drugs our all Bausch conclude in Before a update was & Bausch in for in with the formerly and XXXX. questions, program out licensee eyecare brief Bausch

Phase approved not our micro-dosed Lomb you trial progression partner. shown that CHAPERONE drug vision Bifocal, detachment, the than progression this So may Lomb, retinal for XX-month and MicroPine, as glasses for a can Bausch atropine is randomized, myopia are for and licensee or a The lenses more has no Bausch comparing myopic between loss. myopia as and recall, clarity, and slow X U.S. typically & that & of of reduction contact part CHAPERONE agreement were U.S.-based of that with left transferred X.XX% pediatric placebo proprietary double-masked indication related the and in if myopic trial versus costs atropine XXX children. therapies There the untreated, ongoing is MicroPine to Bausch currently of solution this XX% studies to enrollment and years sake in is FDA more. been are our multi-center, enrolling clinical formulation III prescribed as age. is or clinical result retinopathy by Health. planned. children ophthalmic to oversight is is Recall progressing the to XX trial multifocal

original Vision China Arctic in South subsequently Our well. And that August agreement and and agreement for with the we XXXX added announced Korea. MydCombi covers also while MicroPine Greater was as MicroLine, they

licenses be in myopia all now are The programs. to significant in highest opportunity Vision China. in XX from Arctic So estimates of for myopia and children that of XX% X our children Chinese Education pediatric suffered risk. estimated MicroPine a Ministry of nearly at million represents the current XXXX all particular

provides development Our agreement milestones. for to in with Vision Arctic addition royalties sales

MicroPine be company. our source approved, funds when significant and if So could to of non-dilutive a

presbyopia enrolled the has Arctic Vision Finally, first we've study. now patient announced that recently in its

million the over and additional license license So progressing we Data fees in earn an million nicely. the years. potential generated expenses to have $XX approximately have reimbursable and net license in is that next development and agreements milestones program X $XX

upon As approved, Eyenovia if royalties as significant also noted, sales earn well. can commercialization,

We ophthalmic in to we are believe leverage pipeline needs the additional potential we unmet also indications. as continuing opportunities technology address to Optejet large assess can expansion

each opportunities. out we glaucoma, expansion as California new with and a eye Pipeline our significant facility. consideration was dry anti-inflammatories, anti-infectives, building City, include examples Some significant Redwood market were

III VISION-X pleased quarter. key presbyopia in in data And one, summarize So to advance continuing our trial, III to our top rapidly expect we our in Phase Phase highlights X date. today, continue conclusion, line we performance and enrolling to the are program. with patients third we MicroLine be our are To

CEO would added We Directors also meaningful of of Board first preparing actively these planned quarter our this transition NDA approved, ahead year a give validate which resubmission for our are the to us and We clinical dispensing of MydCombi the of fourth our product milestones. and and commercial expertise our technology. on regulatory in Optejet significant executed if

the provides Our to operational Bausch our Vision manufacturing Redwood in capacity our California relationships. Arctic license new And agreements next City, and development existing progressing this potential line meaningful state-of-the-art possibly & years. sight and well for royalties complement manufacturing of and as offer and with were within opportunity X additional well regulatory Lomb as to continue now is sales milestones facility contract to the

that open So would prepared concludes to questions. call the our We remarks. to Operator? now like up

Operator

Thalmann. Matt from comes question of first line Ladenburg Our Instructions] Kaplan [Operator from the

Matt Kaplan

Michael, congratulations title. on new your

Michael Rowe

Matt. you, Thank

Matt Kaplan

Just in mentioned that MydCombi. out launch? stage stage means and terms you how that a would what us of, give sense a you that launch that and why Can how for planned -- of roll a was

Michael Rowe

Yes.

plan to technology within because that geared weeks the is have for approval our new We'll We're the half to after going system go next roll approval want -- It's be do the of large of sure doctors, and way of year. a experience to people things MydCombi a out that But a beta So we we them have first and doing make and be an with going learn it bugs it optimal doctors, launch the national. product. out can. this can it's test remember, technology, new all get with launch. because new like the is prepared the that is -- a we in and almost everything train practices group may a that or before and beta

current we of are offices to what XX% that those with now. I think address up So we the resources staffing geared have you'll see about is and

we'll expand money going under do any And a after have experience have of that. we additional belt, not expend bit we're that. to once So our to that and

Matt Kaplan

as in looking to top the line in data term? near respect comes it to the And and out Okay. should there, data we VISION-X That's you're then for close as what be study, MicroLine getting helpful. the with

Michael Rowe

primary active gain the versus control of percentage the will the course group. patients the X-line endpoint of looking group who be is a Well, everybody at in have

So so you'll at far everybody that's overall be then for there. looked That's we masked want adverse trial profile. ache where looking the data there. And was the than that for a in see to statistically X%. event I headache/brow less significant We've the result said the in

So we're profile. looking at the right

FDA that. XX to top NDA. have And III part to then which the meeting, which is end that coming takes we of registration an with about set plan out that, our FDA. a of our Phase with be the our Assuming simultaneous efficacy the would line, go up days start after the preparing put And little for the of to time. together batches meet that save with we'll doing meeting NDA

Matt Kaplan

it does the take long batches? to how And registration complete

Michael Rowe

registration year. take batches the Well, a full

as we The batches So the is they're the VISION-X. We'll right just better. not sooner possible. because that for and those can to as want go trigger efficient start into making be registration that, successful the inexpensive we

Operator

Instructions] next line comes of [Operator investor. question Our the an [ph], Alex from Matthews

Unidentified Analyst

be use it's -- X eye approval to out dispensing over-the-counter approved, drops? going want drugs Optejet, approval? expect for for it's also, within purchase, for if when months, for find to you or do X I it regular And available months would take

Michael Rowe

for that's take have they with is something be you that, see which have and It they other have to other of And But products of like eye technology has substantial the a other developed to these It's Optejet We things can ways these or marry would actually in where can Optejet put is people beginning. other the to it's like strategies are not us, Yes. with we dry The don't so and and studies. use why their interest. one that it. we to glaucoma, an appreciate means dispensed. container have the to is partner having investor. primary the that not could is we Alex, do can fill they good talking And areas from if technology first with see registration you worlds. use to of intended drug of in to might eye very into you but with it an or good they our all, it that dropper being both the squeeze with license best thank companies that. products. drugs our very And actively companies if like there it

your clock For that your for approval I question? refile once file -- MydCombi, second is at the for the NDA question, point. months X we Did answer

Unidentified Analyst

Yes.

Michael Rowe

very Thank much. you

Operator

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

Leonard Yaffe

having successor. on congratulations incredible obsolesced yourself an Sean, with

all you So succeeded is simply. pretty My around. Michael for question

the lot the the of have launch from talking the in of the to terms learned you Allergan, or then On when pluses product commercials, commercials seeing what the think, might you and I launch VUITY from of optometrists better could have they learned and what ophthalmologists the in with a and launch from But do you product, minuses year? stopped. started that you next

Michael Rowe

Len. your Well, And for correct you Thank your going calling Yaffe. thank for and to name, I'm support. last you,

there's interest in The first thing tremendous we a that learned a is presbyopia. for pharmacological option

I about when everybody it. was went the gate doctors talking Allergan direct-to-consumer with was their campaign, think it. asking the out about Everybody

of having for that So very learned concept high. the presbyopia treating very, is a pharmaceutical we've option

a that's of bring what side about a for people probably headache that's better also positive, we've people in learned we the one that big absolutely the positive. ache also of because having is like products. table brow to the and least system that their the is and effect that delivery very addresses thing terms So a What

those the So two were positives.

and The the up that out right to important we've how a what's learned is third is who this of it I for patients coming thing think heads give are doctors product.

has And like other XX-year-old they I say said that. really we've it. have the for what for best. really people is or XX, always this We've asking a which they heard presbyopic designed where and products for are example, coming office more not and patients from work into very XX For designed been people are between that's freshly product who have these things been like who doctors with careful less

for to is out is phone can be function. people glasses if to is functional What get they'd glasses. that look good, at to really right they're and this and papers without between vision. is -- who having the what set XX are learned to we've most like their XX looking their on. They're of not to right It's trying what grade think not able teachers, their looking patient without grab cell I they're the of which term kind So they expectation,

it’s setting really the you’re what of frankly, expectation those things. our offers the of answer I get. So to going think And all for best product, X

Leonard Yaffe

that mentioned age XX you And were in there range who… presbyops the million

Michael Rowe

money. Who have

Leonard Yaffe

to who have wearing. are money Yes, and glass naïve

Michael Rowe

Yes.

Leonard Yaffe

I was wondering what your expectations are for the at the arrive revenue per of patient U.S. per year a so size we could in kind market potential

Michael Rowe

with Well, price market has average, And we that our -- Optejet patient discussed said a cartridge. $XXX be had research on our people year. probably a around a previously that the would times somewhere specifically would X that fill

per of So give that revenue an the patient. would you estimate

Operator

session. and over closing Officer, we the reached Michael comments. the Rowe, for like Executive end turn Ladies Chief would gentlemen, And now the to you. question-and-answer to Thank have I of the conference Mr.

Michael Rowe

joining line with we we available us. development. the quarter in X program or presbyopia again currently MicroLine is believe We you, to call. successful for remain Optejet on progress commercial sight were concludes We thank and to Put and our potential continue clinical track many have hope MydCombi key That and today’s that advantages over significant And we conveying NDA clear to near you. simply, the the distinct across products future. Thank programs. of everybody. in in year the with progressing fourth technology therapies of the we resubmit you Thank this make in

Operator

your conference you. Eyenovia has concluded. you of The now participation. for Thank Thank

You now lines. disconnect your may

Eyenovia (EYEN) 11 Aug 222022 Q2 Earnings call transcript