Oyster Point Pharma (OYST) 19 Feb 212020 Q4 Earnings call transcript

Good evening and welcome to Oyster Point Pharma’s Fourth Quarter 2020 Earnings Conference Call. My name is Josh, and I’ll be your operator today. After the company’s formal remarks, there will be 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 Sir,

release and conference the months call This highlights. a XX, everyone, results quarter fourth recent and ending Point quarter XXXX. business press issued we earnings for evening, our welcome evening, fourth Oyster financial to Pharma’s December containing Good the three

In www.oysterpointrx.com. investor evening XX-K on are we addition, our release and with filed website Form earnings our press the news available at section the our under and that SEC this

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

Following Point and This open conference Nau Pharma. future future prepared questions. up forward-looking contains remarks, the statements regarding Dr. we’ll and John call events for Oyster the of line and my performance

secondary or include market assumed regarding endpoint impact Oyster and and belief our outcomes, and expenses regarding competitive statements and the manage other industry statements operations; of business trends; FDA; growth or development of plans; financial efforts the research, results product expectations; sizing; the COVID-XX; things. possible and environment or Point’s future our to position; predictions commercial position; plans analysis; strategies among our opportunities clinical regarding trial including Forward-looking approvals

Point in circumstances maturely results events obligation update forward-looking different These actual by as conference is from purpose for the discusses law by and representation to based this limited been company upon company’s safety approved no They for to are could that the those the Administration. no to clinical statements Oyster are available for investigated. their investigational as the and made Food and under federal change. statements. which addition, or In call currently are projected marketing have being products statements use are investigation information the not yet today these to Future and which effectiveness they Drug assumes

annual Form under forward-looking greater are information that differ described materially concerning our to detail could with the SEC Executive XXXX. XX-K Pharma. Factors to the will call December company’s on of in Nau, year factors results Chief and XXXX Oyster XX, the caption XX, including the now from statements February filings over Point with Additional report our turn the the President I risk Officer Risk ended in cause SEC, Dr. for filed Jeffrey on

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

of December coming for the on the FDA PDUFA expect know announcing the date for you XX, acceptance of spray acceptance. our of indication nasal release from with signs As Once and submitted dry will OC-XX the symptoms an treatment disease. we to eye In NDA we correspondence for the issue NDA hear in we the a the we XXXX of and press back review are our receipt FDA accepted. if the from regarding NDA days

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

environment scheduled dependent or of the live for in is on a Vegas. there As are X ONSET-X for either through Meeting of fluent November the are be XXrd the time Ophthalmology of in live Academy The Surgery to Vision New in through date be a meeting meeting virtually May ophthalmology Ophthalmology Xst Point’s and major of the And be a be Cataract preparing through Meeting American the at in July plan at will potential XXth to Annual will through May the XXXX attend and will and XXth launch Research data number from held meetings Society present Maui. XXth. announced. Phase details Xth for presented we The current pandemic. with XXXX and American The Royal XXth light Eye we Refractive Xth. be XXXX held the in this Association from that will held Las Orleans virtually Hawaiian Oyster

we our clinical year believe forward the highlight world the real are at what the and a of program various We where in space. dataset a is from ophthalmic population looking strongest the dry meetings the development are showcase to able treatment from eye to data we

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

currently for mind formulation in preservative surface drops. been branded OC-XX we phases that preservatives patient which side care is a these moderate provide the nasal intend million and preparedness, has kicking approved dry three commercial States those with We nasal people harmful common and X as unmet Thank spares with campaign spray United patients off audience, with currently state the if with over large the eye broad dry people We disease are which treated From segment product million ocular small eye on is have therapeutic planning topical This from our long-term a in launch diagnosed disruption of you, compelling the safety and a disease. free with disease including is a address this believe importance ocular and perspective, of patients. effects Jeff. quarter. homeostasis. disease, reframe tear over abandoned being to and awareness are the with severe a the associated dry naturally has has practitioners proportion the disease comfort inflammatory diagnosed mild, eye options. of disease around approximately market and film patients been that that of needs therapeutic these available tried profile Only disease how The tear a care and the disease eye film component and in may primarily eye eye a narrative who includes [ph] of homeostasis developed million XX educate alone. Historically dry a eye the a the on impacts sequel tear instability dry later-stage focused to of opinion film which in a education X

positioning will focused bit advisory including post consist dialogue approval. which boards OC-XX will profile starting OC-XX and remain of a second extremely XXXX. on with with a in done research therapeutic about payers also quite possible number payers, of and We've early of of The the phase best occur we obtaining value proposition,

We is which nasal current XX% to hiring products. the would At campaigns therapeutic be practitioner XXX spray novel The out broad continuing plan care and the between patient launch the MOA on route build prescriber of marketing FDA representatives, team upcoming of our third stage approximately which target on our year. to XXX direct-to-consumer post administration. the will education eye approval leveraging eye dry of sales base focus throughout and and focused

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

Thank fourth you, financial Oyster John. results. will quarter a of brief I Pharma’s provide Point now overview

the filed fourth SEC with in as XX-K Additional quarter evening. our the found Form results this financial well that detail as our was can about be annual

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

compared period related expenses in anticipation expenses decrease for and same development for XXXX The December XXXX. The in expected the XXXX the commercialization cash higher result quarter compensation and company head were OC-XX planning in $X.X the the cash As expenses license was million, $XX FDA was XXXX other primarily with expense were if and October of primarily submission. quarter as an were advancement equivalents the compared NDA XXXX. costs quarter payroll to $XX.X company's The million programs by partially expenses clinical count expense of the of stock-based ONSET-X non-exclusive for cost Pfizer of NDA of same for of regulatory fourth million was continued incurred fourth U.S. of million including $X.X an for May OC-XX December period preclinical million, and $XXX.X trial in expenditures X of during $X of research in the offset quarter in launch XX, to to the related $X.X fees $XXX.X the the $X.X increase employee million primarily fourth selling million to as lower Phase the fourth XXXX XXXX, of Total in in approved. million costs a of management CMC made reflects higher connection incurred in to XXXX. and $X to in administrative due amount increase research million. the in XXXX. XXXX. higher general to to the compared the The of increase The million compared was submission Total company agreement amount advancement the data $X.X due and XX, higher million to million, clinical of of and This the December OC-XX. $X.X million due XXXX of to development $XX.X completion in

line other an was up for our expenses will expansion overview million operating With general and the and company's publicly in traded company. open over the that results, operators now questions. I $X.X the organization of administrative the the financial there as call increase turn due to to of of to Additionally a

Instructions] [Operator Rama comes question Anupam from with JPMorgan. first Our

You may with proceed your questions.

ones still anything right you for at and for February right question recent or should analysis XX XX the data OC-XX two that terms conferences? in the of something from the for the so will it's here on sitting medical meetings should we're when PDUFA me so hear like And XX days here there highlighted, we be filing related looking where we December timelines be is quick COVID at would new Just for you mentioned second thinking be these about additional for then PDUFA? any Thanks much. is on

just first Thanks Anupam for though the I'll from review the the for question question. everyone timelines to remind the take FDA. first,

as day in writing XX-month us FDA to So product, we a review have is standard this a provide is cycle required the to and feedback XXX(b)(X) by XX.

filed XX, So a as in just we our XXXX. December NDA back reminder,

so in had stated we And remarks, release. with good window. we're do as we conversations We've XX the within press that will that issue once still our letter day a we prepared receive FDA. And

already For will analysis. the as line top probably second be this do acceptances of of have number well It combination data. additional year question, as with data a we a

go who analysis on, to a in the team brought have our we've medical We robust has dataset. now are some fairly additional started great affairs that through that of

expect ASCRS so the at we virtually the on annual and meeting. Annual the to at were recently And would Meeting podium accepted be ARVO

at window timeframe, of to And presentations so, there of Ophthalmology we'll looking then the as into as into to March we data submit the And well. get American intend we meetings. where present the both for those get be to Academy have we'll

next with from Tara comes question Sandler. Our Piper Bancroft

may proceed You your with question.

a had or payers if I details provide that setting sorts. same your can't TrueTear hearing be you're coverage guess treatment on as think on step yet is what the from on do vein required? and will anticipate and from you of sentiment of paradigm? intranasal you guess positioning And first-line more the you delivery a And through you for the detailed especially the coverage the through the I Do of discussions experiences that general using lens in product? read have any and

Yes. Tara… Thanks

Go John. ahead sorry. Oh

had to to TrueTear research line not with some as headboards Yes. formulary OC-XX. the perspective, What Thanks ocular this insurance bit the we've done do a was address from down commercial was extensive reimbursed medical we've device as the expect I a a date pair a around from payers. Medicare standard traditional of list Tara. the perspective. well we've question on had will pairs Since education, that TrueTear and quite we is

good So the to as then product It's namely key of contracting competitive the a contracting. we for what of on we have the Medicare have for of for differentiation for plans. that XXXX going wait they're And to commercial to well looking listing idea be expect get as we year. competitive cycle the

to first-line very We dry are as position dossier and monotherapy disease symptoms. strategy. compelling in contracting competitive for used be And that going we're a building eye with the for with signs

comes Ken Co. & Cowen from with question next Cacciatore Our

may proceed You question. your with

of Xiidra was of right, understanding I Restasis appreciate went think little Hi call. locked talk what bit the had Dan and pricing of that what Xiidra that wondering lessons a some around from - a launch kind John the the this Jeff, of a a it. maybe about I some bit that of went I bit have maybe can little I a they’re pricing John background into little intimate and a wrong you issues thanks battle. got they for learned and

around here? game wondering hard feel fascinated real Shire really condition of if that on stable lastly you out how have general we an kind kind time underlying that how where it's that obviously marketplaces with is of then that? DTC seeing the now COVID, by So the DTC aggressively now in all mentioned just and went that for into was the is and just trends pretty I stricken you. any lot can Thank out kind market with you but evolving interested share kind And just and you of obviously it little so a more so bit And plan plays also that advertising, marketplace a commentary? in Novartis back of the of just interesting thoughts with you Xiidra market us there, the you're more

questions. Yes address these Ken I'll

Let's in start the marketplace general. kind with of

market provider. as One field easily it’s the the quite the dry as could the that identify and interactor going our react with not behind going initially only learn this direct-to-consumer well put but more the eyes double-digits care we and to and targeting perspective more they're taken sensitive the that of we've on really is payer favorable seen so educating wide, Especially as grow coming positive Xiidra things getting an Medicare, be coverage, on be patients as high market that do for we’re consumer. market very well disease product we've a around eye away. consumer into XX% the from eventually much having your good investment a our lot We've from spray promotionally did seen it. an force launch profile, was and both campaign when dry effort we're nasal is plan then the with that's ask treatment and checked we We're we disease as getting market getting as to a digitally more efforts very precise quite lesson extensive to therapeutic for the is, that eye coverage when as net casting the something get as DTC

You mentioned also pricing.

think cost on kind basis. all wholesale and on market, a price. are all four are now think that $XXX range the approved of products pricing I the settled they acquisition there $XXX that the know I And of at branded that wax you has branded products, between them monthly

product few And now. payers know how as have XX think for of the from last A is We lot feel competitors question think that stabilized market evolving, a we around on of years on that do of quite these has a around the products I been that a has market market But later of pricing be new approach strategy. the in and disease, still more important space been now and it's of for you plus used to I years that stage that has homeostasis as the moderate OC-XX component. regards kind the that a restoring that regards I market. kind on to been as in market come acting such tear this to market contracting feel more to We four the such focus headroom film is as the overall going inflammatory lot moderate severe in disease disease. be natural and film conducive mild to addition is tear upstream upstream on potential. have

around quite be commercialization able going well our a of we're that education therapeutic excited we'll So, are as to prescription segment, and of to as that the efforts expansion market. be grow lot segment that the

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

You question. with proceed your may

so ability thanks that to And sense on anything and neurotrophic Perhaps keratopathy taking any the might else could And in for corneal of expected guys you're in about in study, the Hi, specifically for might dry near-term? and few curious then the think takeaways the unmet to you relative Olympia maybe improve then OC-XX from the additional and how the could OC-XX be questions the broader eye thinking help pursuing experience from there's rationale about me. about contextualize speak more need and just that OC-XX you just label general indication? us whether more expansion in a this staining?

Yes, thanks, great questions. great Those are Patrick.

think one who about patients So think as think keratopathy we peripheral the this cornea. it's has their understand is things is only as neuropathy important disease, in we disease When that neurotrophic the patients about I almost is diabetic to it of think about state. with a,

brain the underlying to feedback not the nerve in blink plexus to say that is tear. or So providing back cornea

completely production, in that The of epithelium underlying because these Therefore by We breakdown a from healthy. do ocular way only this get is works nerves OC-XX we the nasal which those can it the corneal for we a natural but actually film blinking also so stimulate tear tear product patients spray lack a because important bypassing think not production. surface. day. is times can we and really And many keep

epidermal of than because previously, day will are in rely underlying stated have we growth dry twice these don’t produces that we a three a Because program in factors other things could natural treatment stimulation corneal therapy myriad work a for from We And hyperplasia get Stage taking internally. growth the beneficial way actually we are time factor, gland the its NK to in film think that’s growth treating three we keratopathy, we nerve nerve And as system. X on we you plexus. out and our really surface. quite those look at for for or contemplating patient Stage and as more of that know benefit did its long the that corneal agent those patients may we therapies including a of payer as patients. those that and And through There all But important program. lacrimal be patients, the Stage the NK of to there that whole we tear neurotrophic as the out only X ulcer that be that different as the one X, we’re benefit corneal When the today develop we such healing eye have regardless have look that to you a could whether patients of those be right stages of think actually think going factor all OC-XX a pipeline that we focused trials the patients. Stage standalone for now OC-XX patients to clinical X for with stages

bridge we think potentially this during time. to that at ultimately that sort we patients And be of those a so, look may could that product

of few When across to look really a on able ONSET-X that study. will of data be data improvement forward this we’re ONSET-X the be side corneal areas we again, on sorry And Stage come, encouraged companies Stage two we again X a the the program surface. keep the scale in So in but the But We are areas and shown action cornea have the at we’re additional health unique certain one, of mind did more to right staining points of in for the all directional that a saw of just different and data dry population. mechanism days. all we focused is, area. the just as in significant really X has corneal that improve and you of ONSET-X couple And areas to had one as by of patients presenting data now product NEI XX the we think we the only cornea. saw in we of the that - things studies with statistically our ONSET-X then one the is benefit OCO regards the see very to to we on the staining. not go subsets we one in of some patient eye And treated specific multiple

looking So we give focused proparacaine at we scores Schirmer to had of some sometimes study on which exacerbate And also patient staining the the staining. often were pretty over know of topical resolution can course take we the second, time. period because

we period period ocular of to so time be population. that the much on over XX-day see in look a much really when patient data we as excited have won’t treating surface. longer and keratitis obviously at We’ll So neurotrophic we’re proparacaine

you. will Thank over call closing to any Dr. Nau back now I the for turn remarks.

our to team the made in of with OC-XX for Thank of indications developing surface. progress therapies that additional you, efficient this spray the product. the assets focused ophthalmic in application the through that initially execution I’m goal expand when in team’s Point look on initial to for transformative other advancing I pipeline ocular specifically of has XXXX to we Operator. program forward IND May nasal proud development filed the the Oyster continued the began pipeline through and developing diseases line extremely

capabilities In our quarter manufacturing approved. to to well a XXXX, also force XXXX as sales continue plan to R&D continued clinical development have our our In the spray including team. sized we commercial of launch ophthalmic capabilities nasal enhance addition, strengthen as in OC-XX fourth bolster competitively we will and if

Point into hope your world-class like today stays that and We family driven ophthalmology a us I’d to build to thank everyone for and healthy. In safe company. I are closing, joining Oyster

Thank Ladies for you. call. this gentlemen, participating. conference you Thank and concludes today’s

disconnect. may You now