Oyster Point Pharma (OYST) 9 May 212021 Q1 Earnings call transcript

Good evening, and welcome to Oyster Point Pharma's First Quarter 2021 Earnings Conference Call. My name is Sarah, and I will be your operator today. After the company's formal remarks, there will be a question-and-answer session. At this time, I would like to turn the call over to Mr. Daniel Lochner, Oyster Point Pharma's Chief Financial Officer. ahead. go Please

release and quarter everyone, ending the Point highlights. a Oyster XX, results quarter Good recent and conference welcome call First business press issued we earnings This months our for Pharma first XXXX. financial evening, evening, to containing the March X

section In Investor on the www.oysterpointrx.com. XX-Q the close at was addition, market release and our with filed today, Form earnings our press available website of the under the News our are and that SEC after

Joining Pharma; us are Officer. Jeffrey Snisarenko, on our call Dr. Officer Commercial Nau, today Executive Chief of President Chief and and Oyster Point John

Following Dr. open will for Nau, we questions. Snisarenko Mr. prepared remarks, the line my up and

of will forward-looking events call, Oyster regarding we pharma. the During make future statements future Point performance and the

forward-looking upon Point the differ possible trends, information company and development plans, update position, industry from COVID-XX and sizing, efforts and based product potential our to future Oyster include of results materially regarding -- could circumstances and and decision-making, analysis expectations, opportunities, expenses statements. research, our approvals available strategies to these including regarding Forward-looking clinical statements company's regarding other or assumes or projected change. Oyster financial no of market as statements business FDA things. plans obligation manage trial or assumed statements today, results statements are outcomes, environment position, and among the These our secondary in events actual impact competitive growth endpoint the the to the belief commercial Point's and operations, Future

the the Risk May filings our forward-looking results cause XXXX. February greater with which Factors for could Form for in December SEC, on differ the XX-Q statements XXXX, XXXX, SEC detail our with year annual that our report including the on from on XX, the in company's factors quarterly on materially concerning the information Additional March the are XXXX, described was SEC X, filed XX-K and report caption Form filed with on ended ended XX, quarter XX, to

this is which have not Drug products Gap] Food conference are are the In for under and U.S. call that their for and investigational no addition, are Nau, its Jeffrey and discusses [Audio limited use which now yet currently approved being safety by representation marketing Executive to Point Dr. as Administration. purposes been clinical They investigation, to turn Chief made for effectiveness I call the Oyster or Officer investigated. over they Pharma. of the will President

on our Dan. everyone, you, us first Thank to call you results recent and joining evening, quarter discuss Good XXXX for our financial highlights. and thank business

may know, you NDA disease treatment XX, of XXXX. on FDA target and is for PDUFA announced As nasal the spray for signs of set for we XXXX, varenicline filing dry had spray the for OC-XX March date the OC-XX accepted action symptoms for nasal eye the that and X, October

II begin as via as punctate pathway this that tear to of OLYMPIA may stage studies OC-XX persistent X believe quarter. OC-XX's for addition of those corneal with to OC-XX epithelial stimulating and keratopathy treatment film of unique the in November development to trial beneficial in for defects. enrollment be the disease, the X the hyperplasia for potential our trigeminal seen we dry keratopathy. clinical epithelial in as parasympathetic neurotrophic preclinical filed of In IND plan eye of action stage We patients an clinical and evaluate mechanism and/or well nasal with natural We Phase spray

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for steadfast. commercial organization pivotal bringing and by vision to from to while innovative company surface expect evolve the nasal committed ocular the remains the a We year OC-XX approved transformative to a potential ocular on development treat call clinical to turn launching and XXXX therapies diseases spray. development disease the QX best-in-class John of our Snisarenko, Point eye that the over preparations Point's we of of and as launch Commercial company of disease to treatments focus a If Chief commercial be like company building to FDA, ophthalmology research remains I nasal in a Officer, would our ongoing dry the patients for in Oyster to and OC-XX XXXX. Pharma Oyster now discuss to into spray

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launch phase and in the preparation second reimbursement. access in is The market of area our

value in extremely of with We many quite the of a possible finalizing put dialogue key focused including advisory meet are about place obtaining payers OC-XX payers being the We've bit compiling to profile needed and with post a the therapeutic positioning dossier OC-XX's payers, with best the quarters. done in to Plans next on and are proposition. order research in pre-approval we approval. of of the start boards, number product X the remain and information

The build third stage to upcoming throughout continuing is the sales team our out year.

products. greater managers, of would on target As of sales continuing and XXX by to than hiring followed XXX QX XX% In sales representatives, hired plan we are mentioned eye which with we out between the team current disease sales base to prescriber dry build 'XX, hiring previously, sales of the we the leadership therapeutic representatives.

route to for optometry in sales to trained the take is FDA hired, launch, direct-to-patient, team professional have At that focus administration. goal campaigns, patient post PDUFA be marketing on to and and scheduled with and nasal spray education onboarded, place and X novel and date. of Our shortly will plans our OC-XX's the are eye ready our broad leveraging large for order MOA be congresses after DTP, approval, care entire certified ophthalmology

spray profile Officer, Financial to patients. disease, will both nasal financial call eye as first-in-class I back to the first Chief treat dry and product well of potential over be discuss as the prescribers turn to symptoms quarter Point's a now compelling OC-XX's may Oyster As to our signs Lochner, Dan results.

Thank Oyster results. you, John. of Point brief overview Pharma's I'll a financial provide quarter first

found quarter Additional our details in our quarterly results about well this the filed that be SEC can XX-Q with Form was our first evening. financial as as

in period of per million net first Pharma quarter Oyster of per share loss share XXXX, loss million $X.XX $XX.X For net $XX.X reported $X.XX a or Point the compared for to same a or of the XXXX.

development was in $XXX.X to for XX, clinical small The commercial for administrative decrease March with in the programs in XXXX December gain first subsequently cash granted cash fee clinical than of refunded and the and The XXXX $X.X compared completion business in the by application to XXXX XXXX. FDA increase in waiver paid the equivalents million of $X.X XXXX. of of same in expensed company $X.X a million well NDA and $XX.X and April Selling, primarily quarter to of primarily if XXXX. XXXX million other quarter expenses primarily million general $XXX.X of period the expenses primarily anticipated the FDA were launch and of incurred CMC connection fourth as if the due ONSET-X in of higher the compared for by research XXXX. $X.X application XX, for February $X.X due fee The of was the the of XXXX. preclinical million, first NDA's $XX.X and, the million were for $X.X lower company's $X.X the December company's of to approved in million XXXX. in OC-XX, Phase driven first and period XXXX. May first to compared the anticipation million the The total commercial a period during same recording As was in in $X.X The the as of higher and research were development advancement additional expenditures of XXXX in were million for trial FDA, expense by as OC-XX same U.S. planning of million III headcount quarter increase million continued XXXX, million XXXX, in expense expenses approved to the payroll-related an to of by The due expenses quarter quarter the due launch.

the to increase spending of professional up an affairs. With medical services questions. to overview call now general will and fees for in operator increase financials in that million other of administrative increased an in for was turn cost I the administrative to over there $X.X Additionally, line due open and the expenses and our

Our Ken [Operator line first & Company. the Cowen question comes Instructions] from of Cacciatore with

of be that the could we ago. unique and the review there premium? a just with couple the a questions. wasn't any if pricing Xiidra. interaction products, initial any could position Is the believe I maybe you having still I that of long it's of Jeff, just And environment right too any John, comment a for rollout would in the around process us of then early, us but know branded also, a Or kind far. Restasis you're give anything at so that that? Just then, sense And you're a give now commentary on wondered Xiidra agency. the reason color bit you on to

to So that little D wondering Part could previewed bit efficiently. time. some some to I have differently, us, about D you was of talk learnings more you've done if take things I Part maybe been -- already going there, the of a is know could

most maybe can how to you impact the the of that kind pacing might make? efficient that launch So this make

well. the go as Ken, this October pathway chemical FDA you compound, In With through our hope we a of know, entity. Thanks same it had I to the lot PDUFA and date review, the doesn't the as year. doing question, you're in for set new Gap] regards [Audio

expect you'd bit little formal your entity. that review a than chemical So a mid-cycle new with having different process

federal clarify the in I of things things process. often We the for around in have characterize would regulations, requests CMC received minor, agency information code some components to documents and some temperatures from settings them the filing. as and

nothing those to And that we as will review So questions expect continue continues. FDA of that's the the ask concern.

process. wait patiently do their we're to just the we that today, FDA and begun So that review, happy for they've

Thanks, your Great. Ken, question. Jeff, and for thanks,

And low branded with we to low with start plan product. most XXXs Let's of the a of wholesale that acquisition the when XXXs. the into the branded very between OC-XX, range. monthly the From kind a pricing range approved, cost WAC to products of kind of competitive be basis, introduce

branded pricing, competitive but haven't in announced we be want to range. we that rest assured, exact So price

Ken, around think, learnings your around was I Xiidra second the question launch.

dry market the that launch single realize sensitive, drove learnings annum, eye first, X.X growth we direct-to-patient, detailing, eye care education is therapeutic whether is of things dry it, very promotionally the and investment probably double-digit quickly, that One those years. at DTC and call -- The per did growing X to eye on segment Xiidra investment market this into the transferable prescribers digits category, in the but this or it's to very, direct-to-consumer. really prior the these I this the force field of think landscape efforts that market low years, in are is

grow be mild, compelling our patients, precise just our to we want and and therapeutic definitely want we that expand efforts take. severe learnings to direct-to-patient to be very disease. of approval, later very and in and for product kind get not for do be is used the some stage are feel able those as So profile to we market We we moderate once want can reserved

So take activities and it and efforts that some expansion will as well. market take education, will some

Our with from Anupam next the Rama question comes line of JPMorgan.

This is Anupam. call on behalf Tessa the of on

OC-XX? to outline considerations that in you Just you And the When post will one us formulary OC-XX? a key expectation for will you for payer payer Can a require perspective, coverage from from us. order the step-through use approval? have is

well next value perspective, a of doing lot but we've of of product, your quarters. of efforts differentiated The get for really to the MOA, being along that not there now, route right its administration some is meetings also in Tessa. in started show its payer the in very just our in a a part question, building that the on homework competitive as From as to with is couple a contracting those proposition, very Thanks of starting that dossier Yes. books key from this perspective.

be X the commercial to good with So of covered commercial that pretty the XX% will a here we payers, dialogue well. coverage some do starting and end we ranging first with D as speaking aspect of the that again, lives well being considerations, very differentiation of on same perspective. the as And some months, is space. Part the year negotiations XX be and in plus during those by Medicare kind going be plan with from contracting key first as In competitive

to get So we we later, do a come after expect probably year coverage approval. for our Medicare good

XXXX So of we're to frame get kind targeting the time Medicare coverage.

Our comes Piper Sandler. with the question line Joseph from Catanzaro of next

and with opportunities data to But And still those currently in so, both longer-term two have such like and preparations you at how the have similarly, of whether then of of the campaign, one-on-one getting implications driving awareness the discussions? you're for just what ophthalmology was you for that engagement there And curious website as of have I conversations be state we are data? awareness could wondering more meetings could you how maybe physicians, along line of would and characterize disease website launch OC-XX if traffic if picture at level around virtual sort about to of similar the the OC-XX? thought. traffic to physician OC-XX I the raising around meetings just you, the the to terms speak set, think the are

Yes. Great, Joe.

to -- part And it John. just I'm your and of so turn take the to going I'll question -- first over

of meeting this is platform I virtual that investor attend order of is as on this think some happening presentation. cases, or as we to. this an product. in an our were a engage side the But Obviously, in with podium that we're we sometimes questions talks and there to about data, also big if has exponentially have The people us some able are often on at has I'm industry the and ask to in ability digital that of presentation optometry on we those talk happened that hundreds the the -- of go rooms as the One the talks seeing things ophthalmology world. in sheer people and number to an meeting are engage share in-person compared to many those and in meetings up many gone of thousands at to sure

And I intention look soon. think are obviously is had meetings our program, this rather talking been company, even of the point. going back us. it figure all our of this very We is to engagement IIT that And the But platforms. program, just now. with data, But period. the robustly really it to to beginning this great across virtual pandemic, well engaging development because were out continue that forward our time meetings in-person so up we've engagement many in with we clinical trying some keep to to important to we've our summer do it clinical going outside the doing throughout until about able that

so to bit little some of the a And of parts over turn the other John it talk to I'll about question.

very, dryeyeland.com a Jeff. Thanks, website. get and your to question. thank the start to Joe, And bit about to month, without very about little that just good. awareness month we're ago. with just In literally efforts campaign, traffic disease website start a undertake traffic to you the launched that Yes. our regards it the been And more we that's And has to state campaign, did that called DSA for

symposia efforts targeted with And get of targeting the kind we're definitely, have pushes where there digital way the awareness, in through of the with website information. to more get conferences provider different to banner up be associations, conferences of and drive to the working very disease specifically, are the eye to looking which that going we're kind we turn education So care at even advertising, that coming partners. to state

that dry So of whether able going to virtual symposia, And the start they're both and of towards of we'll the back to be and live a with these or year, kind media reframe to narrative kind we those we're dialogue efforts, to feel be flexible whether treating quite address to approach around they're of that bit nimble drive and the eye. channels. half awareness

Instructions] [Operator from of question Our Capital. Patrick LifeSci the Dolezal next comes line with

or OC-XX us some specifically, kind remind a just for that dry existing And of then just eye OC-XX, indications to you you broader Can such conjunctivitis therapeutics? label multiple other have you is, subsets I thinking expansion? pursue rationale contact related expansion pipeline and you're speak neurotrophic keratitis, intolerance, mechanistic as eye has relative know being how and being encompasses segment, a niched of the general more mentioned And all dry the the to for potentially example? you versus holistic of previously manner accessed about to address indications more in besides in potentially question like a been to inflammatory foresee second for sense, do dry more additional the eye plans lens and perhaps of allergic patients which could dry population

appreciate Patrick, We question. Yes. that. the Thanks, for

in imperial increase mechanism why excited our the this the on of we of trials mucins. As not that about -- action. that fluid release of We've gland. it initially to in started administration, study the I but shown can the those pertains only lacrimal surface number so can the degranulate of goblet eye we the of reasons action a the from We've to OC-XX, is clearly when lacrimal shown cells the one were of route we company, the mechanistic we think

do the really them on One cells is, to released understand from is release the but of the not the important think only the lacrimal mucins of we from eye, also also surface things gland. we goblet that I

were and So is lacrimal of eyes inside transcriptional healthy. the to factors, heal if when we organ lacrimal gland it, proteins, gland up-regulation our gland scratch will an beneficial ocular to that gland keep the placing human we get onto lacrimal injure really eye. various that is so mucins example, of the the Even factors components surface, for important cornea. those the we seromucous a of all The of growth

glands. and nasal And has very harnessing that, the can pathway cavity of parasympathetic eye muco-aqueous and so dry and trigeminal atrophic, concept animal interested those know meibomian something able that the that produce not pathway Unfortunately, the pathway, meibomian we're play. been with in lacrimal with pathway cells and into the put also models the from in. patients, onto that up stimulation for we gland come are also they ocular from to many do that stimulate be We that electrical glands surface meibum, may that where the goblet the that's nervous gel

this damage route on stimulation, to is neurotrophic such know surface. then you stimulate as because keratopathy, product we in plexus think disease we keratopathy. sub-basal bypassing that that do mentioned, other cornea. of to put As the With has that that to we're And that to the ocular film benefits we're neurotrophic states nerve tear able there's actually

going And think interesting. launch. surgeries, robust get We program we investigator-initiated And to continuing the all label. that There interested to states, want this things potentially neurotrophic there on is that do to indications the certain so that with we also awareness are be expand begin disease trials around a having dry very a disease. infections for eye uses mechanism ocular often Obviously, We know have other interested intolerance, important. the that some increasing we're like a think in diagnosed as contact diagnosis, with Many fact, suitable in dry it that are in. that's very we eye is we are well, this patients disease. lens has with but indications NK, to overlap product plan may closer space. around very either are we as think be and other keratopathy diabetes we or But to for herpetic that

for things is, Oyster the that we So one science. think of, are on of that Point proud I I'm focused very

clinical where bring to there's are on We unmet need. continuing therapies to focused patients

about do for we talk a we and so surface. various hope continue very And able is as be to forward. to move indications targeted surface ocular But approval, to hopefully, we then and commercial-focused with robust to some clinical-focused, that have programs our of expand continuing an disease. will be We ocular diseases of to very FDA are we develop program, organization different to R&D-focused R&D those continue the and will

So more plans all to come at we with on quarter trial preparations. busy the have soon. NK begin and pipeline, the hopefully But the commercial that OLYMPIA to moment, very inside this

I now closing are further Dr. Nau turn There any no questions. will the call back for over to comments.

Thank strategic Point for to of launch including a XXXX, build has ophthalmic you, capabilities commercial continued operator. Oyster in team nasal if spray The a our the to plans sized fourth fashion, sales approved. quarter in OC-XX competitively force

there disease-focused we as in surface a and companies capabilities see ocular force, ophthalmology a evolution few sales important with of step are this the in space this the As dedicated an company.

manufacturing well we In strengthen to our development continued addition, as our have and clinical capabilities to as team. R&D bolster

to staying everybody into driven ophthalmology healthy. to hope Point a you joining build And your that us thank company. Oyster are I like families closing, world-class safe are and for We In I'd and today.

Thank this your concludes Ladies for and gentlemen, conference today's call. participation. you

now may disconnect. You