OYST - Earnings call transcript Q2 2021 | Oyster Point Pharma, Inc.

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Operator

Good evening, and welcome to Oyster Point Pharma's Second Quarter 2021 Earnings Conference Call. My name is Justin, and I will be your operator today. [Operator Instructions] At this time, I would like to turn the call over to Mr. Daniel Lochner, Oyster Point Pharma's Chief Financial Officer. Please go ahead.

Daniel Lochner

welcome Call Oyster Ending for XXXX. and Quarter Pharma June everyone, Conference Earnings the evening, to Point the Second XX, Good X Months evening, our release and This business a financial recent quarter results containing highlights. issued we second press

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

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

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

our call future of regarding future During statements performance we today, Oyster Point making forward-looking and the be events Pharma. will

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

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

Jeffrey Nau

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

PDUFA dry OC-XX varenicline treatment of October date As nasal eye XX, you symptoms of action spray the is signs the and XXXX. know, our for for target

preparing support OC-XX spray in to the approved currently the if are fourth the We quarter organization of FDA. nasal launch the by

hiring received As you've representatives initiated in in seen and we date, that across from we in organization, extremely To release, and have from have already country. with have Oyster at joining the and of culture interested we more we building are July, X,XXX QX than press the sales excited we our we sales about Point. team the our individuals earnings pleased talent applications here are hired sales are the

awareness medical for and XXXX currently time XXX hire to the been to As PDUFA calendars our representatives the place, this Oyster the communicating in access, our will Point forward are in in date. care payer leading sales already the sales the at in Oyster look With and key industry. recall, plan as communicated calling teams of previously eye Point and we the to providing campaign, dry of both on you eye U.S. state have the may we remainder and one to into payers of of and many sales are information optometry, disease engagement completing sales and building that our our provider-focused team approach field exchange launch. XXXX. to Once XXX ophthalmology payer have teams we already, to we goal access regards hiring deliver we preapproval are representatives on have track we affairs

goal access to for and care eye ensure patients. coverage broad payer providers is focus to Our on achieving

ophthalmology meetings either important light virtually upon major a potential environment the for attend for the prepare of Point of to Oyster we depending As that COVID there the live for current XXXX, number are of or launch, in a remainder are pandemic.

European we'll be XXth, Point be Cataract optometry of will XXXX as the in in I Optometry this this Academy and Refractive The XXXX meeting to meeting meeting for November major Oyster We XXXX. have abstract accepted Amsterdam. these meeting Orleans and acceptance accepted have commend the Ophthalmology meetings rate the abstracts their of presentations of team in New accepted at presented has meeting. American medical Ophthalmology our held and of to to Xth, XXth and well. Academy Surgeons and ophthalmology XXX% meeting in Society Women for want Xrd the that X the will The November Boston present at X Point will affairs American Oyster for held at abstracts year

addition enrolled and was In dry first announced potential evaluate XX, the to XXXX. the of IND that keratopathy X development for spray for nasal filed patient our disease, treatment in the we to Stage of OC-XX November in neurotrophic eye an June OC-XX of

trial expect of stimulating as unique half trigeminal of We that parasympathetic seen preclinical may in natural to and XXXX be and mechanism action We OC-XX's continue film into tear enrollment first believe pathway, beneficial is XXXX. clinical the proportion underdiagnosed a clinical on through the studies, these that of via for based corneal and hyperplasia patients suffering keratopathy. our surface meaningful from think epithelial population population and/or This and/or punctate the with experience, we ocular represent disease. often of patients patient misdiagnosed

with with is Food ahead our for plans Looking platform. the Film to Oyster Therapy Point Gene Tear moving at Enriched earlier-stage Drug with our Administration and pipeline, pre-IND meetings engage

Phage this forward market. develop virus factor past vector for entered its what protein-producing have shown progress Also, In studies, antimicrobial evergreen potential and is Stage first collaboration preclinical we Adaptive with year. quarter, The in and gland lacrimal first into harness We Therapeutics codes the and to secrete half the look our keratopathy. to onto of the to IND-enabling growth surface protein. neurotrophic start the nerve studies continued the has transduce the we a II Stage enter for gene the nerve therapy this III ability be to to agreement will on with growth target to that that human ocular second machinery patients factor the adeno-associated we focus the of the ophthalmic

Our look be our bacterial or year the part XXXX. forward to surface infections focus and of the ocular of segment, of disease state anterior announcing half this and we first will in latter target early

and Lastly, at of activity our and OC-XX recent simpinicline shared we concern. antiviral SARS-CoV-X preclinical on Analyst variants Day past July, this data against OC-XX

in In nasal OC-XX impact dynamics plan the nonhuman pre-exposure the potential pandemic. viral to spray primate investigating believe the post-exposure coronavirus a nasal entry nasal of nonhuman RNA and and hours as a the in reduce that therapy completed to upcoming have a prophylaxis a the recently study meaningful weeks, have could a spray. within it's these represent the viral transmission and compounds well spray, We that with number dramatically we against replication evidence respectively, positively as the of And after XX both XX SARS-CoV-X. studies hours. We complete illustrated approach vivo of nasal with OC-XX to change OC-XX and possibility no the have and of Delta cavity primate study subgenomic exposure, second variant

and and to turn into now to of potential over Point innovative bringing remains building on our primary discuss ophthalmology company the ophthalmic to goal. I best-in-class Commercial disease Pharma Chief to John a like transformative Oyster focus our and vision launch eye commercial for disease nasal dry Our of treatments patients spray Point's Oyster call Officer, preparations in XXXX. ongoing the OC-XX QX Snisarenko, would in

John Snisarenko

our unmet treated proportion over market disease dry The currently the the is options. these tried spray patients eye developed that eye We the Jeff. surface spray eye this focused film with and naturally abandoned mild, States film the branded spares importance on side with a homeostasis with campaign. to impacts care dry dry our these harmful has later-stage believe of dry disease. diagnosed education last of instability X dry perspective, United the in This on been that tear the eye large provide tear a patient approximately currently The primarily has dot in of eye compelling from and the commercial profile. D-R-Y-E-Y-E-L-A-N-D dry to available we disease From progressing provide potential product patients. Historically, found is for common awareness spelled to address may eye therapeutic. practitioners opinion, has inflammatory reframe the XXXX. of moderate be on topical and in approved, segment severe component you, continued small in we is being disease with which, to introduced tear awareness people has associated a million, of with disease our preservative-free launch XX million and that at Only and a it patients, mind, ocular people effects that's early Over in preparations the and how OC-XX underway, and has drops. nasal the diagnosed a eye efforts disease we disease Thank program ocular the a and million therapeutic preservatives X are a traffic and a alone. eye with practitioners have goal That, are as quarter disruption can educate dryeyeland.com who if disease and been care X that nasal needs disease long-term key in initiatives film of Interest high state homeostasis. for of X the narrative community been around sequelae and we www.dryeyeland.com, educate XXXX, to eye campaign quarter. disease website The In are prelaunch outlined com.

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

and OC-XX's and dossier Our has payers product preapproval value with the about have we profile proposition. dialogue been started therapeutic completed,

We've of best in to continue on research post obtaining positioning a remain a OC-XX boards, with key the will approval. meet quite extremely advisory also many upcoming payers, focused with the done including number the of quarter. of and lot players of we possible We

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

of mentioned, previously disease XXX prescriber representatives, than plan therapeutic of which hiring current eye between we greater target we dry As the base XX% XXX on would products. to

as end regional been As as QX of managers hired. our directors well of district the the have 'XX, all sales

calling remaining date. and have addition, with and trained awareness of representatives in certified hiring have our trained July, disease group to specialists The our teammates of care state currently PDUFA posted, onboarded, been to and is initiated are prior been In onboarded, eye them efforts. hired, on this the positions and sales our goal education already sales has was

and OC-XX's leveraging administration. novel and campaign targeted approval, with stated MOA be some positions high have date. As Point our allowed in attract sales to sales been interest talent. planned to great previously, Jeff Upon our very over eye X,XXX leadership marketing post-FDA direct-to-patient nasal with applicants Oyster will a route has patient This education professional broad on and our of launch care plan for spray focus

supported Our be and patient support marketing sales program. efforts will a with comprehensive

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

Daniel Lochner

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

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

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

compared in company was nasal quarter of of including to were of expenses, and driven additional of significant in quarter varenicline Selling in the costs of as to million the million June $XXX.X of as well XX, of the inventory as headcount the as XXXX filing approved, to the primarily to expenses same was the compensation period research payroll-related lower commercial were XXXX, the by $X.X XXXX. spray, of million decrease the for XXXX and XXXX. of second $X.X quarter quarter due general by compared Total well XXXX. and in of $XXX.X second $XX.X $X.X the which related increase compared included expenses the million cash XX, expenses quarter of driven million million As The OC-XX of million higher XXXX as for CMC for compared second XXXX. in stock-based to by were December development XXXX, if U.S. cash XXXX. to preapproval anticipation period the incurred spending launch expense fourth for and higher million NDA second preparation $X.X December same $X.X expenses The administrative of equivalents

information of technology incurred in during to the $X the financials, of higher the to an affairs administrative in $X.X to second legal, that the call accounting, expenses our of costs will In office-related other to also addition, other The and the prepared general company XXXX. company finish I million 'XX and of medical back compared remarks. million incurred overview turn quarter increase our facilities, related With quarter of second now amount Jeff costs.

Jeffrey Nau

you, Thank Dan.

Before announce, today. hot to taking of presses, the and excited questions, we this are off also is the X agreements earlier signing

in OrbiMed Opportunities agreement a to to with our business enable announced earnings strategy. and entered our funding & in aggregate go-to-market into credit as our will First, $XXX Credit we release, plan provide on us Royalty us million which continue executing have

disease nasal has eye for both that China. With Greater Ji update, we press operator agreement Xing a Oyster addition, that also in on entered commercialize the preparation for to to for and spray continue an to and as turn OC-XX execute In line with Oyster Pharmaceuticals to partners release with with develop Point patients I'll Point into the license up announced dry exclusive additional call the questions. we and to collaborating commercialization. issued open looks our OC-XX over now forward

Operator

and question our comes from Ku And first Instructions] Stacy Company. [Operator from Cowen

Stacy Ku

Congratulations progress. the on

recent your maybe, European agreement maybe Xing on licensing been back the the based on potentially magnitude very for. with Ji So your on kind last Maybe these interested into needed? from the might of or OC-XX, in the approval. conferences, the for thoughts feedback point potential about has talk this of of And partnership and are you kind and some is you ophthalmology starting first, a agreement clinicians? exciting given what what EU if for be opportunity OC-XX partnering, buzz Or before of what some partner getting looking just education

Jeffrey Nau

Yes. Great, Stacy.

to And over part the some question. on a it additional And to call. add I'll turn the the lot John the of second take so I'll for Thanks first color then allow part.

regulatory development the Point with at partnership. as both, development partnership, we look is that well disease. is that Xing I objectives. company China, we a patients the about the a also would also has both So going commercial side also who partnering say commercial can finding severe capabilities. have look and and are And similar Oyster a like we type someone a is in and any world. excited research we're more I throughout main capabilities in say, a on, with excited as would who on many And and like capabilities. we also what clinical I has are those there stage focused are And about X an where opportunity partner would capabilities. there really important as Ji partners flip not is R&D partners We're see really in And partner Europe, world as at that the we are say, throughout treat the One of really when to the interested who really capabilities of

really As development the on in we in United patient a program, focus you population. broad know, our States,

we so there then to the and bit patients. moderate severe market prescription mild, failed over-the-counter who really they for therapy. patients lubricating is to sense different little therapies push And in a European included have that tries the a multiple on go government or drop before The

that that in as throughout severe opportunity we'll trials around population, year, about. present And of some that excited we showcase from there which course highlighting we patient we're our data clinical really data be population. that to so severe OC-XX really of that, we this is think And have the

of excitement to far. the go is I of excited lot excited in-person really the market, conferences a once the engage so able share conferences. ophthalmology together about this to again. the to been back excited bringing to would be we administration, just excited around As we've really and began everyone product data as ophthalmology mechanism to about we're that novel route about able the for whole, get back say, A to year, of action, that the

my And through that, remarks, various Optometry American at stated do American medical Ophthalmology. Academy will of prepared in Academy as and the so we to I we've sharing and conferences, been continue the of

of number podium a presentations. have We

both as John able year podium So talk is could his we'll continue goes the posters Society data, then I well at on. American recent to to on also And as Cataract allow the be maybe Refractive what as to the do Surgery. about on share of some our experience and of

John Snisarenko

for thanks, And Stacy, Thanks, Yes. Jeff. question. your

to with A physicians of of a presentations the of lot eye have was from we prescribe eye tears. ability of eye lot drops additional hear reiterating an the fact aware conferences that that the lot treat what they're we're that really Oyster world-class the chemicals, is tears, the taking are One conditions. things to that A of they excited trial approach physicians mentioned And And dry Point. something about company. different They're quite the these ocular their to really results. the different on the awareness was actually seen specifically, own great for they and these natural awareness the of at Point surface these this kind patients the have of natural over and Oyster we're of ability of sparing using produce clinical building care was keep the over. body company,

cycle So about. there, to we that think ability is dry building. that excited the something excitement the the is in upstream disease it's And have and work they're fact I the eye

Operator

Rama next from question JPMorgan. comes Anupam our from And

Anupam Rama

from for learning OC-XX? or it related that launch here note apply do can Kala. that are And seems you dry differently I you think disappointing is was like And reading just that from in today launch earlier you to my colleague, Neyor's what Chris eye.

Jeffrey Nau

here on is the a from Dan chime questions. Anupam, lot color do the of there. the launch some John and deliver I'll have in thanks as well, And learnings for some can what

John Snisarenko

we to a been including for the Anupam, different different product things, many for novel. From past. Thanks, this Kala's One reiterate that is wanted prescribed I such in mechanism the question. have a eye of -- perspective, is Yes. very loteprednol. steroid is that's dry has loteprednol thing action And a

there seen a with our the They're something novel with approach, We very lot a payers, there. novel the armamentarium that new to we very even with and so uptake are limitations discussions initial feel far. differentiation. the are from we've to is molecule, very different that some have So of with they offer anti-inflammatories something have that that quite excited to to and the a add feel out

So our will different. be very positioning

With the right potential patients. moderate chronic the through approval, we'd and the patients to treat mild, severe spectrum

think a launch, marketing differentiation, to be well in around bit force have I bit field the in a So as offerings. and we'll of patient quite as our also we quite and investing regards services

Daniel Lochner

the doing And I just abandonment focused being to a sure our capabilities very the along would sure say same on of occur. patient areas journey could market on best patient services to where really any position the access we're and in be patient thing, avoid we're

amount spending And time significant journey. quite being diligent sure the those that we're of parts so being a we're in all on

So at position a can in be of drive really robust we TRx. launch, the time to

Operator

Joe next Piper question comes from And our Catanzaro Sandler. from

Joe Catanzaro

quick one one just Maybe Perfect. me. for

the transparent FDA about with have guys process. during been NDA pretty review the You the interactions

think I request. noted some previously you CMC

FDA, a decision the any those updates on October additional requests nature requests have and or made confidence before Just the whether will wondering that be provide there from of perhaps of the if been could there, PDUFA? the degree you any

Jeffrey Nau

Joe. Thanks question, for the

we the review goes with agency So process along. to continue as the engage

our remain October PDUFA on We action continue Again, track. date XX. to is

before, having sooner, sometime expectation into start XX negotiations. if would those be labeling would not Our days we

planned as things so ahead surprises. additional And with no are moving

on engage according continue to action questions or in we and be answer date so And to available PDUFA that October currently. to track any

Joe Catanzaro

it. Got Okay.

think had that would CMC be some won't questions some facility expectations whether will a I as of the your requests. approval there to manufacturing there the of been preapproval or be to you inspection? there Are inspection given

Jeffrey Nau

Yes.

So great question.

been facilities, we've at catching been moment, their feedback that out where up at facilities especially those not they've with been from agency So to inspect received focus that the the the primarily them. has least has

there new facilities as a by been market visited the to are, can coming you so of number have And agency. imagine, with products that never

facility by enough within visited fortunate the few has last been are that the our years. We agency

of out are the market. manufacturing come after So agency be the date, line to a we the it discretion or in have will PDUFA that on they before PDUFA is producing as currently the the and whether but products at facility the that entered date

So the whether position, particular we is out would post feel FDA preapproval with committing not approval. that they comfortable or although to be

Operator

And comes Dolezal Patrick from LifeSci Instructions] [Operator from Capital. question next our

Patrick Dolezal

quite ultimately preemptive. perhaps in bit guidance symptoms label tear It not in labeling But you just related and how production? extent so sounds versus on any for provide signs the label the like might matter much you're this And could another possible, a yet discussions the to comment to be setting. versus one might potential increased further real-world

Jeffrey Nau

Great Yes. Patrick. Thanks, question.

we yet the schedule. according the yes, negotiation not So to process planned have begun

we Although fact, guidance day dry filed put did FDA draft out before. is what after this NDA, I hadn't disease, the eye which December around will existed say the year, of in in

And think look there in we So the that what's important NDA. they at for our document. at out it's folks agency as guidance take they we from eye look that at the products dry were before product, look filed document I a provided with guidance other consistent to as really

So we're into see to very put it print. happy

in of document, we that top our or Schirmer's on and in its in change. that look secondary prespecified of the and met, study, you know, score points of point. signs primary own, primary we had end categorical ONSET-X In categorical point ONSET-X on primary the only prestated analysis a but not guidance had you signs of and dry our of you'll in post-hoc end trial, that improvements we which, categorical also meaningful symptoms ONSET-X symptoms supports end millimeters indication change had also the more And the symptoms As take the XX or then change eye the disease. in if of was at see,

that we're that going very think that other there point out we symptoms being the companies marketplace. strong have signs out all label. and We in meaningful are would and don't are So out we're consider among equal. clinically that real are a the with robust relevant. in signs We all the we and have labels there We symptoms position label to I feel think a that there.

could so will And asked regards less land to it where billion And we're what one for and that regards with a than excited label do we we'll limited label. one world the just as to out pertains or is currently question think not you fact call, a I the symptoms product sales label, RESTASIS with to $X.X the symptom that's which label, has say, at point level. the with with the the that is signs product that real with all symptoms, versus necessarily signs the to there, in that a would signs doing and and something what

And think less say more would probably from HCP from the product important less the the patients and really HCPs I of I about are what's what investors. about worried the label the than so that And perspective perspective, is profile. and

also to And that that patients going daily find works time. has and relief that over like. It's chronic are them benefits so product twice a going able when give a used to I to think It's as it quick very rapidly. product, product to you're pertains our

stated as I patient, So a in broad we of our before. clinical population trials, treated very

on with novel add the it's in you route product this then be only I marketplace. going And to these that's think of characteristics the administration.

to launch are this we product. So excited super

Our launch product. sales excited are teams the to

looking we're and to into PDUFA approval. having that date so And forward heading

Patrick Dolezal

And helpful. the Super to more, if Ji I agreement. just one Xing may, pertaining

these the details timing near that potential term. it line sales-based further there's helpful whether in relative extent sight and be could provide size a would the of to to Just milestones, you on and the as of development

Jeffrey Nau

additional sure. agreement Well, $XX.X provide turn can he the question term. And and near the noted million in paid Dan over on be I'll some then itself. out the payment agreement, upfront the will in the as we to color Yes, of

Daniel Lochner

the say, to Absolutely. we an with And million. to development additional would receive we theater. of would working in the $X I China current course, And be OC-XX still occurring then plan the that, payments of would intend FDA we're in addition as development But move And with States, that calendar the then, what year. approval Ji United forward in Xing. would on be additional in receive potentially

of providing payments point numbers that that those the in at not of the guidance. course, be you But release would into additional incorporated we're So the saw today.

Operator

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

Jeffrey Nau

Thank you, operator, and the for on call thanks joining today. to who's everybody

this Academy really American as meetings Ophthalmology U.S. we we everything and this spray the building Pharmaceuticals, OC-XX approved, we Point extending in collaboration in Boston that's Academy being first out with reach the continue China our of to at pipeline, not and American the Pharma, with execute of Oyster only into and As in the to first our forward nasal launch excited We're marketplace. but on Orleans with company. look New happening also launch our our varenicline fourth product creating year fall Oyster Point ophthalmology into a about with potentially the quarter, if expanding world-class Ji Optometry Xing

closing, a in tonight us thank So everybody for and evening. great want to for having joining I

Operator

This concludes today's conference participating. you call. for Thank

now disconnect. You may

Oyster Point Pharma (OYST) 8 Aug 212021 Q2 Earnings call transcript