Earnings call transcript Q2 2023

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Operator

Greetings. Welcome to the Eyenovia Second Quarter 2023 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. At this time, I would like to hand the call over to your moderator, Eric Ribner of Investor Relations. Thank you.

begin. may You

Eric Ribner

John and conference everyone are Eyenovia’s quarter Financial second Chief Bren Operating Good Kern. and welcome audio earnings Officer, Chief Rowe; call Officer, today and webcast. XXXX Chief Executive Officer, afternoon, Michael to Gandolfo; With Eyenovia’s me

for issued XX-Q release as to everyone Form afternoon, report and press results June tomorrow, release X as be announcing read XX, release for Eyenovia’s on filed encourage ended www.eyenovia.com. we This months are the XXXX. period with We financial the well quarterly X ending and filed a at press company’s website report The recent will quarter also June XX, which XXXX, today’s XX, our available most the press August SEC annual XX-K. on and our

being conference reference. webcast the this for be company’s will addition, call website archived to and In future is

we forward-looking XX-K described from which forward-looking report and are results risks, statements. annual These will detail forward-looking management making on certain provision subject today Form to and under which be harbor or of of some that the of We could those differ today’s to more note filings. number the Reform Securities caution during is are Please implied due risks the statements other Actual Please the in note and Act. be approval. call, call, concepts listeners business. with product the the Litigation on safe discussing company’s materially to stated call candidates, discussed on FDA that also yet Eyenovia’s a statements products, have covered those will by in our SEC Private receive information uncertainties that associated

to required applicable as date this after time-sensitive events or may date broadcast, be is revise except or reflect conference accurate this securities of obligation circumstances update by Eyenovia XXXX. conference call live information undertakes forward-looking any call, to that no as This statements the contains August XX, the of law. only of

Michael? With Rowe, like call turn to Executive to I’d said, the over Michael that Officer. Eyenovia’s Chief

Michael Rowe

Eric to you, financial welcome, everyone results second call. our and XXXX quarter Thank conference

extremely am with We productive this you an have quarter, to and afternoon. excited our share second progress I

begin During spoke of our partnering our monetize to beyond our leverage launch efforts and Mydcombi with to last call, the of targeted Optejet goal other of programs. our our own we companies conference and development technology

update we for topics, both these first with will recent starting our an provide Mydcombi of Today, commercial sale. and

FDA mydriasis ophthalmic As [indiscernible] and combination you’ll only approval for received inducing fixed dilation recall tropicamide in first is procedures spray May, of for and diagnostic only desired. the the and we and pupil then Mydcombi, of phenylephrine short-term

innovative proud and Optejet the the thought are ophthalmic dispensing first community, the of partners, the highlighted important annual in and We advancement OCTANE June, investors. have the Forum potential technology the featured where our including leaders leverages we product FDA-approved future of was that at This Tech device. industry delivered Ophthalmology Mydcombi Optejet to nature to

and initiated offices. thrilled and together, of benefits of can streamline we a help technicians practices sales of now group patient patients themselves, experiencing to learning have management. Mydcombi product to Ophthalmologists, professional Mydcombi targeted We’re the are with how are the and optometrists,

daily receipt to world-renowned, incorporate we commercial first As into becomes achieved practice. Mydcombi our license, New of who sale pharmacy Radcliffe, announced our week of last Nathan to we ophthalmologist, York upon first Mydcombi Dr. his board-certified

Orange, we California our soon OC received, and California Last is in pharmacy this state. as conducted as training Retina week, initiating license sales in we anticipate at

adding we manufacturing our Mydcombi, patients, his process doctors, ramp secondary additional and from but potential manufacturing We additional this site. including of support as with Mydcombi, demand the are Coastline facility sites as of To provide increased only sites utilizing technicians details only capacity future commercial will with as and receiving a therapies positive we anticipate meet feedback during overview. to increase not formally well will will up. and These anticipate additional ophthalmic marketing manufacturing end, additional Redwood sales City the Bren already are and that to in us provide Optejet.

would If find more to our product, progress saying track to are and what Mydcombi, launch doctors hear like at about mydcombi.com. you out about the can go you patients website and the

to other more Now about talk I’d companies. partnerships technology with to and monetize like a leverage through bit our Optejet the efforts

than a fewer have ophthalmic discussions variety this topical We with active engaged across of area markets. in in X no companies

Some This compatible be the are products arrangements take of something able because if closure tests both as the include to determine is We first longer for to spray than any performance would discussions the those that material very system. as these being container Optejet. announce shortly. these anticipate is with first discussion And under well assumed compatibility. we true need of usually,

of bring the near-term discussions all unique a prescribers, with is to delivery asset drug and and/or to company. opportunities these patients to both of while for goal best leading Our worlds new or capital technology marry providing revenue our with the

for I’ll we Apersure intended for the with developing associated Apersure, candidate in the an are presbyopia. brand-name on is now pilocarpine-based a near that project. update vision therapeutic proprietary MicroLine our provide topical temporary on-demand improvement

alone for near and million hardening eyes’ As of resources is United know, of people pay between you represents XX the in market over and the may a wore glasses XX, XX States cash This the addressable otherwise have product. lens blurred presbyopia ages vision. the age-related who the causing never

billion research proprietary alone. be $X suggests market in could market Our U.S. nearly the this annual

requirement new use. on this been which designed program forward These we for with stability filing use the to an on continue package As we late XX last XXXX. clear anticipate the advanced in fourth received our to in-home on registration towards Apersure approximately X front. of make of Gen FDA, more file FDA manufactured for product City the those quarter, months the of optimized feedback XX and year. of our that plan from this or before progress commence we will after device, the discussed real-time and batches for NDA, facility, we this we path batches NDA, a application, Redwood final in is manufacturing will being to Optejet we run NDA months drug quarter a be outlining has Based data

treatment for drug-device from topical the and the and presbyopia on a differs those current option drug combination. was market Apersure in development, that

we it approved, Optejet, effect that as five will market, the concept We offering or meet by vision any As pair or one-third other patients distinguished for a If would those [indiscernible] have times of out with available. themselves changes include the invisible has described only the drops, this as be using tested optometrists in with optometrists, many administered who stand the These of such, found presbyopia potentially the spray believe use all Apersure spray design, capture research and that the competing able doctors that an and estimated believe Apersure their than needs profile. of when will pharmaceutical side is option Apersure the not as second to both have by Apersure that desirable. glasses and as would of other with been better patients market one eyeglasses. XXX remaining way for glasses along the pharmaceutical ophthalmic eye Apersure wearing ease some much ergonomic market. that as of its as they products, could to two-third

At over our our Bren Kern, Operating this manufacturing I’d Bren? the point, to call update. turn Chief to Officer, like for

Bren Kern

Michael. you, Thank

The we capabilities been As for filed additional PDUFA mid-November year the for site, an experience To to manufacturing expeditiously the use with upon be out clinical Optejet. Coastline Michael of registration manufacturing expand supply has build date the us International. batches over Coastline of the have us a to already mentioned, Apersure. Mydcombi launch, Mydcombi-targeted we continue given to FDA has a our FDA in site XXXX and has request use. for the a manufacturing support and approved for extensive approve of with for

Following the smooth to Coastline team eager anticipate a commercial to PDUFA, manufacturing we is our the up needs. support at ramp and be

FDA site without facility hearing We an FDA soon our City manufacturing dates. PDUFA also the submitted additional anticipate Redwood from and to the as

facility a lines. support qualifying this City of the and Eyenovia Apersure remainder step to made line. Gen has is fill-and-finish begin scheduled significant to our progress qualifying monumental The team product drug production equipment the media in month, this Redwood Our in X fills

As XXXX. targeting of fourth we the are batches in mentioned, initiation quarter Michael the of Apersure registration

facility Reno continues ejector and progress to our make in Additionally, establishing base significant manufacturing.

been On has are production in facility the our final Optejet, of Mydcombi. be continue last with the to construction growth of increased and equipment Since enhance installation to progress noted to the activities then, manufacturing availability meet that anticipated received, has earnings qualification we demand growing equipment underway and the call, has of the I be made taken completed commercial excited our approval planning an the With been manufacturing. occupancy. is the we’ll about we’ve positioned better capacity, stages. and particularly staff

like I update. to to a to the provide John? John financial over Gandolfo, would now Chief our Financial call turn Officer,

John Gandolfo

Bren. Thanks,

second to of $X.XX second approximately Research second loss million or the the For the compared $X.X as per expenses XXXX. quarter a per development net approximately and second of for was approximately compared $X.X million XXXX. for the or to XXXX, $X.XX share net for totaled $X.X million quarter quarter quarter XXXX million loss of of share $X.X of

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

XXXX were the million expenses approximately operating for the million quarter Total of compared $X XXXX. second second quarter $X.X of for to

additional credit compared cash was XX, Mydcombi. includes As approximately an with equivalents our were of and million approval of line $X the of million Avenue to FDA XXXX, June $XX.X XX, drawdown Capital by million on XXXX. that cash December triggered This as company’s $XX.X

our licensing for June noted a as have above, the million development revenues, XXXX, from in reimbursement Vision balance For XXXX. Arctic second our and approximately license half XX, on expect $XXX,XXX we cash to partners brief of a addition of payment receivables expenses of in the of from $X update product approximately

our all therapy left to Korea. is – in formulation for or and XX% and the to vision in atropine myopia Phase There now the three if of progression. currently licensing for retinopathy drug untreated, update loss. as continuing on this proprietary MicroPine MicroPine, existing clinical Canada myopia FDA-approved for myopic no indication, shown can now China ongoing studies for our and pediatric U.S. Vision of and by I’ll Health in retinal the It as slow a an products enroll Bausch program CHAPERONE progression has update well X result Arctic more. in this I’ll provide detachment, trial South Bausch+Lomb reduction are for of been in

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

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

continuing address large unmet needs pipeline similar continue our also agreement, opportunities will are expansion Optejet to potential leverage and we additional to indications. to to We and ophthalmic the assess Formosa technology

Eyenovia Finally, effective April the Russell market XXXX, part the market largest reconstitution XX, annual as stocks indices The as and in ranked Russell small-cap Russell by to capitalization. added captures broad Indexes total of of was reconstitution. U.S. XXXX X,XXX the XXXX June

through are we XXXX. initiated in for received conclusion, initiate the performance of fourth half to highlights. and We offices. presbyopia select the key expected So are very the Apersure sales professional FDA summarize pleased of To Mydcombi first Registration quarter with our batches XXXX. program some of approval in of to

multiple ophthalmic We advance potential leverage and discussions to Optejet to the continue indications. with partners additional

potential facilities build and for with our regulatory agreements avenue to development production are Arctic manufacturing the remain and Coastline come late in licensing City and and promising progressing as XXXX royalties. We’re manufacturing our our early continuing as XXXX, support Vision sales to a well Mydcombi with milestones for out to Redwood well And capabilities, significant respectively. Bausch+Lomb anticipated and

That We open like to call the questions. to our prepared now concludes Operator? remarks would today.

Operator

your Thank question. the line [Operator Our come Caufield you. of with first H.C. Matthew Instructions] Wainwright. proceed with questions from Please

Matthew Caufield

Hey, okay? me, guys. you Can hear

Michael Rowe

Yes.

Matthew Caufield

Optejet Great. team obviously, for taking ongoing questions. congrats, this our the thanks Michal quarter. And on progress and

questions. two of first So

on for point X of X, where a MicroLine there wondering development manufacturing Gen design. Regarding X will Mydcombi? prospectively device, Just for well particularly all of be future streamlining kind if Apersure based is as Gen devices presbyopia, of there’s as all for are on-demand Gen the any if in the sort Optejets both or the

Michael Rowe

yes. because ultimately, has aesthetically, is, to nicer product, X does. answer Gen than ergonomically The question. a just we far believe, from but Gen the that And Gen for reason X Matt, you, parts Thank is and is going the X X we’re fewer Gen not it

is actually build. you the within it X while that parts a system simpler and So make Gen and use costly to easier the lot identical, to spray less the

So everything get in the onto long-term, do that to we want platform.

Matthew Caufield

Very helpful. one on then of the it. And kind presbyopia progress. Got just follow-up

studies the electronic for have presently? been safety still and microbial are human efforts any those of stability drug all Generation of X So factor, have those completed? ongoing challenge, Or any kind data,

Michael Rowe

Some of those are completed.

all are end Some they of be this done will year. the ongoing, by probably but

is any similar that not very they’re to there rate-limiting So in with Gen of did X. there’s this because causes us nothing we a lot step what and pause a the

stability. the is step rate-limiting the really XX-month So

Matthew Caufield

And congrats on the quarter. Got Alright, guys. this thank again it, very progress much, very you helpful.

Michael Rowe

Matt. you, Thank

Operator

you. Thank

questions next Matt line proceed questions. your of with the Please with come Kaplan from Thalmann. Our Ladenburg

Raymond Wu

Hi, this of I the for Raymond of our see licenses, being so Thanks. we proud question. for to how as Matt. was of wondering, I about in think launches that, the progresses on Thanks state it in used. uptake Mydcombi relating progress. terms should taking to I a for kind the and all thanks is follow-up. I’m have Congrats guess forth?

Michael Rowe

you I you. to or take can? up this John, do It’s want to

John Gandolfo

No, it’s okay.

towards – give a with Coastline to place. Mydcombi targeted able in the to once coming of to mentioned, we’ll focusing the we that better community the of be the that initially, feel with visibility end program. on this as We think as manufacturing I that Mydcombi, launch have year, So investor we’re respect guidance Michael the up

So at able we this will With licenses XXXX, to we’re that that expect be highlighted speaking third partnership key less call, ours. or than quarter to guidance no a for remain of time. probably with beyond we’ll they which earnings as parties in focus opportunities, obviously be give to probably respect November, Michael well. four

be company. a So that to for continues the major focus

Raymond Wu

getting? Okay. definitely. there Yes. I for as guess see you’re you was are are ready – would any I to incorporate launch you And you that next a like appreciate that wondering, are color. No, getting feedback year? you national I do how early

Michael Rowe

for because and get now people used Yes. dilated It’s York. it actually on than They the speaking a they is the funny with And used to that well What XX a the and it. it were that they it, hours just then dilation question not told last like you finding of us is asked of on the patients out started week. rest like few the of you it today. with by need, they if to of the offices every finding this don’t long, they the at what a is is technicians get the They’ve the drops, we patient, using they’re because one that some positive hours back more through New in patients. may less use positive is Mydcombi, duration and hours, which product they’re the today, And reasons a dilated they get also it eye more you which normal. like, is being it’s up dilated one as end And is with for you of efficacy day. looking very they

some looking we’re more. that So definitely into

Raymond Wu

I queue. jump will helpful. Thanks. very detail, that Appreciate back in

Michael Rowe

you. Thank

Operator

time. like to I’m you. any questions showing Thank this the comments. floor further I’d no for at closing management back hand to

Michael Rowe

thanks, and joining today, that call. concludes and you, for us today’s Thank everybody,

our had year so the with we We’ve approval sale pleased commercial had first of FDA very far. and are have Mydcombi. We

through joining forward continued and We look presbyopia capabilities the beyond. momentum our and continuing quarter XXXX program [indiscernible]. manufacturing are look again grow. of rest in We is to you update Thank progressing, us. to forward for the Our Apersure third to

Operator

appreciate Thank your you. This does conclude We today’s teleconference. participation.

may this at the day. disconnect lines time. of You your your rest Enjoy

Eyenovia (EYEN) 10 Aug 232023 Q2 Earnings call transcript