OYST - Earnings call transcript Q3 2020 | Oyster Point Pharma, Inc.

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Operator

Good evening and welcome to Oyster Point Pharma's third-quarter 2020 earnings conference call. My name is Dilem, and I'll be your operator today. [Operator instructions] I'd like to turn the call over to Mr. Daniel Lochner, Oyster Point Pharma's chief financial officer. Sir, please go ahead.

Daniel Lochner

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

addition, to of initial shelf provide flexibility anniversary registration additional In one and established filed forward. the our the financial passed public company the given an year company statement offering, a recently after-market going offering

this filed evening Form our available XX-Q Form with and the under release were SEC website New press earnings our Our and section are www.oysterpointrx.com. S-X on and Investor that the at

us Joining call our on today.

Our Snisarenko, Nau, and chief of officer John Dr. officer. Jeffrey chief Point executive commercial and president Pharma; Oyster

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

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

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

Risk the ended could the are including that from filings detail in Factors materially the will our cause for to with November results over to caption officer factors our filed forward-looking XX-Q Nau, on information Dr. on turn executive statements with I greater company's Form in now the described Pharma. X, Additional and concerning Jeffrey September that report Oyster differ quarter was call XXXX. quarterly the SEC, of chief XX, XXXX under the Point SEC president

Jeffrey Nau

our Thank XXXX the our to update like proactive would its Good to our and SARS-CoV-X and of pandemic environment Pharma I virus pipeline. advance Oyster discuss continues regarding an evening, steps our pandemic. employees, you, highlights. and Point ongoing Dan. ensure operations, the to business R&D of you and on impact virus the provide for monitor continue everyone, financial to to maintain for maintain the date, its third-quarter to To Point safety continued us has thank is working today joining to continuity remote results call recent business of taking Pharma Oyster a SARS-CoV-X employees.

track and eye Administration and to date, the X to positive announced In is for Oyster contractors continued as significant results OC-XX to OC-XX operations And May, close disruption company's onsite the pandemic. QX our Food XXXX. top-line the spray R&D virus of to from their company of Point addition, nasal Point by QX launch. approved result in not Drug with team remains a its targeting in have SARS-CoV-X contact finalize be the dry has the Oyster FDA, on Phase submission would XXXX In subjects in contractors. The to reported with If a trial disease. package NDA

public the November on we've the our we will we As made data, as you a see deck compiled NDA, able dive deeper into been website. have in our that take to corporate

deck, We X.X our the top mill show of line see both analyses from November analyses. mill dose scores. on Slide have corporate ONSET-X Phase milligram and XX will per in significant From groups in our statistically per these X.X improvements categorical mean Phase provided and milligram ONSET-Xand Xb changes you integrated X data that the Schirmer's

at Importantly, vehicle. those the from this bilateral improvement a see approach. significant study effect we improvement nasal benefit illustrating treatment eye eye, When data in seen analysis, and see we efficacy integrated our in groups both both fellow versus the spray our with symptom statistically looking the

dose experience. pronounced that controlled see higher X.X per many adverse we versus benefit low will group that illustrative symptom an clinic patients even in larger mill a milligram benefit with the of vehicle more environment, in the Although with the environment, high-airflow group, the dose in environment humidity,

of of use integrated spray. the treatment the OC-XX development data the of data milligram mill benefit these for per providers to X.X to addition that between we decision eye our of we of totality believe may analysis our data, pronounced is highlights see include FDA concomitant statistical world covariant as use real difference of supports this the and dry OC-XX approval integrated Based even analysis dose tears program, care artificial the expect groups. We the and we signs eye nasal the our of the treatment believe from on both placebo more with might disease. In a in the of symptoms to the seek and in models,

beneficial transformative pathway patients [indiscernible] via bringing the to begin those surface our with epithelial of well clinical to and X treatment X hyperplasia Neurotrophic will OC-XX X company. as of turn first in potential of John to building Oyster committed of FDA, intend now ocular and an In IND the Stage ophthalmology Phase the clinical is to We the and/or treatments accepted remain mechanism discuss OC-XX quarter enrolling this chief In OC-XXfor Keratitis. file parasympathetic may natural If XXXX. persistent Snisarenko, for corneal the epithelial dry believe in OC-XX's defects. Olympia eye Stage of a innovative the tear addition launch unique evaluate we to commercial by our as XXXX. the action half of with IND film be the into our for patients that we development stimulating the trigeminal trial for call development team will preparations officer, disease I of QX Point's summary, commercial of to ongoing potential Pharma to over Point Oyster best-in-class and disease,

John Snisarenko

alone. currently a compelling therapeutic eye tried that therapeutic over XX that, believe has unmet The available some of small diagnosed adults with Jeff. people a million million, have dry you, if million these this disease a United Thank the OC-XX with We with being proportion of patients, Only X market dry are is approximately large dry and disease options. in large eye segment diagnosed market. States treated the X over may profile needs addressable address abandoned approved, and the of currently

of our sealing to with dry second force prescriber As an would XXX in target reps, of current half XXX the planning we organization on to team, continue out we a XX% sales close products. which eye commercial experienced the therapeutic XXXX, are build base of between to of

believe that be critical. also OC-XX to will patient We access

back Dan payer third-quarter OC-XX. Point's discuss the to programs distribution, to access competitive includes financial results. access strategy along I for broad to Our broad Lochner, call with enable financial our patient Oyster chief over support coverage, pharmacy now officer, patient comprehensive will contracting turn to

Daniel Lochner

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

our can our SEC about found that this in Additional results filed detail evening. was third-quarter with XX-Q be Form the

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

September a costs Total was increase due XXXX quarter $X.X a for higher XXXX. million. payroll-related as $X.X $X.X fourth headcount during due of third to were the well were expense cash expenses $X.X and million payable the associated -- OC-XX U.S. development the in company fourth The clinical The the $X.X due planning of with million, reflects trial completion the XXXX. expenses submission XXXX. quarter an $X.X quarter Phase in quarter as XXXX. in CMC of The advancement for equivalents of and of to and commercial XXXX expense higher XXXX. XX, compensation third to primarily XX, the third stock-based $XXX.X compared $X.X and was million for expenses increase quarter planned research same of as XXXX. if compared in of OC-XX the cash company XXXX, million, administrative As in company's the pre-clinical to incurred to were Total million, of $XXX.X clinical of other launch anticipation primarily of expenses, XXXX, The and in general to of million higher in million of the the and of for December lower period $X million, incurred and approved NDA period X same including development in ONSET-X research May million compared

there was turn to of administrative Additionally, With call -- a expanse overview questions. that of other to the units operating in expansion organization line traded financials, the general the the our expenses will of and publicly $X.X the increase company. for million an open and as I now due operator over to

Operator

Ku question from first of Stacy line from our And comes Cowen. instructions] [Operator you. Thank

You may begin.

Stacy Ku

on all. questions for Thanks Hi, the and progress. congrats taking my

items walk if you through some you've first then remaining whether NDA my of there the of preparedness beyond the requirements level additional regarding the And a follow-up. can there? check submission had interactions acceptance and to So of And FDA and any of question assuming the some stability. us regulatory about the maybe have your and any filing, gating with is manufacturing other just I are

Jeffrey Nau

for Stacy, lot, question. a thanks Yes, the

summer that meeting the on We primarily have with CMC. the had focused over a FDA pre-NDA

pull, with the our continue end including NDA all meeting We track which quarter. on the timeline, for CMC will to of the occur that of requirements stability be toward

NDA. no this we so currently foresee gating time that at of the point And with items filing in

will on together batches manufacturing As we for prepare organization to be we into XXXX, working validation our pull with launch. to go focused

of in supply. batches the allow very good sets shape And three so those go are regards standard launch are to in -- pretty to industry, into will validation us with the which

commercial the to typical your ordinary product. nothing So out of the regards of launch with

Stacy Ku

remind as Restasis? products then thinking -- your Got pricing in early about understand you branded be products Can it. how you'll eye you generic conversations, you'll with be us like peer how us eye can help terms as well competitive dry the landscape? And in

Jeffrey Nau

sure. Yes,

John going question to I turn over think I'm to Snisarenko. that

John Snisarenko

Thank you to product the in upon on initial We that competitive market In remain with we competitively if the OC-XX QX our they're we at and branded pricing be at on also that, the products the branded therapeutic of feel existing payer payor 'XX profile our for time. the end of feedback look that's to will conversations, are Stacy. we differentiation, that the products, OC-XX payer approval have regards initial -- and interested at level good their the based is mix. in our very some the adding

Stacy Ku

terms thinking to up And Restasis, in how the just on about you're of OC-XX? follow generic that

John Snisarenko

Yes, step all through generic in manage any products. And feel of Restasis, we the any we're be this awaiting will class, a generic the day that there terms now. generic the payers branded way do the for entries

tier and years on that Restasis So One for would would be these patients the along -- tried over X thereafter. generic branded and over already reasons and different two a interesting has have abandoned the been products products market follow many one statistic the them. with Restasis reasons Xiidra, million then have the

new dry go lot through for offer a and So disease. stepped already can new patients there's of that -- available that's directly have eye onto something a

Stacy Ku

Got much really on so quarter. Thanks it. That's good and congrats another helpful.

Operator

question from Morgan. come of from Anupam Rama the JP line will Our next

may begin. You

Unidentified Analyst

on Hey. all Good afternoon, Hope Anupam. well. of Tess guys. on call the is This is behalf

congestion about Maybe there I potential can practices the in. Just is I that guess, are virtual and environment talk about you on at type? are some so targeting two company thinking far? by launch us. messaging physicians you're launch all with And of for that particularly quick are in living current Thanks segmentation awareness you of so we're market ones a guess, how the OC-XX, ongoing from ahead Perhaps the And activities medical one prep. any the much. patient how question then, resonating more

Jeffrey Nau

Thanks, Yes. Tess.

the So gone meetings part I'll regularly. navigating the we've And question been as first with conference I'll have John. pretty as current answer of obviously, schedule it pass over all and the peer of to virtual, been companies. then our these presenting We, have

at presented We've at presented So we've Optometry. the American of Academy ASCRS the meeting.

of XXXX, Academy environment. another will that'll be up, a the we And coming virtual Although announcing virtual American meeting. and shortly meetings then many we the are Ophthalmology as go is of in continuing be into

really some move presenting plan and we will present to look of we continue we the so and data to programs data as ONSET-X sets forward. exciting forward ONSET-X have we And to that out

So our plan. that'll a of be part

with many also articles so submission review our to move number be planning science forward of different are of We of of OC-XX, as as and peer the a surrounding part a of well plan. that'll studies a of

get outreach do fashion will to as side on affairs as team much virtual plan So out the on his our peer in I our at these think we've being continue present of to focus we we trying team I front medical builds journal more on putting science, And that to when the obviously, in disseminate closer articles to the the to overall continued really you focus look the can. meetings, as as message, as a John as physicians, virtual possibly launch. and commercial think grow at well reviewed continues

and all the that so obviously, but a these new So, I would able more fairly get at in-person where of the in it relates There we've to to little some been as we all environment and like we'd meetings And the message up coming activities can to out think well are share data. time be our the be virtual market that meetings bit able then been conferences talk John maybe and about not be attended. have perfect launch. to

John Snisarenko

Yes. Jeff. Thanks,

And in So and and inflammatory of of role reserved the targets introduce will tear severe an The the pre-launch natural professional our disease that of the It's dry They and main program film to really importance focus, of focus tend tears. education target moderate be state the component. on market to on to used the for high-care options extensive current audience. kind more be kind launch kind XXXX. going the segment. of homeostasis to it

role you the eye. and to patients. broad We designed also when about loss of pivotal of is one of in to of do film X the question from that looked we segmentation, we eye on we suffer the when audience at educate regards your tear natural homeostasis dry And dry want a to Phase the wanted things address trial

moderate, need the included of mild, of of criteria, ranging So broad from patients the to the mild a really Phase set the through address broader in we trial, the of commercialize, right or when of the and results the huge X severe unmet the terms audience inclusion patients. a most to we that patients. do we from plan to severe Because of severe through

Operator

of instructions] [Operator you. Dolezal Capital. question next Thank Our will come from line Patrick from LifeSci

You may begin.

Unidentified Analyst

is on This for Two from Thanks. us. everyone. Hi, our Congrats for on Patrick. question. taking progress. continued Thanks Valentina the

maybe for additional opportunity for then on in well? much waiting something the do some us And this indication the an of just products, DTC the here plan maybe your describe force? and given rationale question And in eye as on success Keratitis, guys to sales immediately versus the of Thanks. PDMs the place DTC characterize roll marketing board? historic DTC Neurotrophic is can on So own emphasis you you come campaigns out would dry market to versus you

Jeffrey Nau

Sure.

I'll John to of the part it question. the address So, turn to over first

John Snisarenko

Jeff. In DTC regards at Yes. we're to DCC and Thanks, kind strategy the the equally. commercialization three the efforts, pillars program of of our looking

force So be component. the will an sales important

the to and, patient eye patient important the consumer Of course, the of access care educating payer course, drug prescriber. will access be and the and

And do we in then So direct-to-consumer we of will pears And OC-XX prescription sensitive ordering eye quite the a lot dry probably applied, growth after area. of investment invest when approval. in that in this substantially be market a get after digit we've is the double DTC list one that, to the historically very we terms because of plan of promotional to reserve to market. seen is the we our have seen

be an it's timing So that will important component perspective. from but everything

our to that will is efforts get from as really quick well. we're that uptake coverage, initial payer force sure definitely we Our going make be target to as and and broad perspective field

Jeffrey Nau

Great.

which dealing in part States. epidemiology patients affects XX,XXX disease on second XX estimates that or Keratitis, low Neurotrophic the United nerve probably contains patient. approximately United we for And as of of contains the a OC-XX by number really, is -- question with so action of concept we this like feel know mechanism the is natural it to We're components The and own as that growth really allow of the diabetes tear surface, recent the whole factor of out film behind And X the things a half we've and which that proteins helpful heard with OC-XX States to growth is films. the tear us for Neurotrophic on and different shooting Keratitis. estimates stimulate Keratitis including in Stage high a the do host could allows their will form has may have Neurotrophic very lipids patients to actually include patient factors, the ocular Stage some of which focused the with natural a of X stimulate

one patients available in is obviously many to perfect. with of of that's close And natural tears, autologous makeup corneal very these they're the its for a the is hyperesthesia. film, tear So although treatments experiencing today these patients, which serum not

to their surface. that patient that need we exist tells a feeling surface the So, the is often feedback would in brain they're That lubricate stimulate to healthy impaired. the currently lacrimal loop gland ocular not corneal

of mechanism that that is helpful And cornea, diseased the of various occurs lacrimal the that when OC-XX, forms the a tear that the healthy that film that And glands there barrier unique by stimulate stimulate RNA in action feedback and able oftentimes mechanism allows good, passage do goblet we lacrimal proteins. ocular the nasal [indiscernible] cells, being the the transcription increases through of to so, there's messenger gland surface. of a onto to know glands, patient

so, because want indications we just healing applicable force. invest population What's really about sales the gland's And any for proteins interesting any having and that additional this for. really is OC-XX be eye the And other to be first number onto secreted do ocular the of will stimulate disease potential to lacrimal this is harness not to without what us directly dry surface. force, cornea those is is the does take that think do of adds to the we sales this in another this state a indication

this Phase very And so study development on Phase we'll we'll X that shortly. to X begin move the data, from and year, hopefully

Operator

And showing at back over turn further not to closing I'm Jeffrey I'd you. questions Thank for time. the any call any this Nau like remarks. to

Jeffrey Nau

we you, space We and the go generated should a program broad our the translate disease We're clinical have data into believe disease. dry ONSET-X operator. eye dry the improvements We XXXX in potential developed bringing trials. for Thank differentiated believe Point that similar ONSET-X trial showing clinic. symptoms that development the data of strong that eye trial product of with in treatment in Oyster Pharma population excited the signs both and market pivotal eye to for outcomes patients the includes dry to into clinical in disease a

family I in fourth and for approved. continue affairs and healthy thank your the well hope a OC-XX and world a nasal you joining like as the XXXX, We everyone quarter with holiday bolstered stay organization us Point preparation safe season. our today. strong I a commercial as for medical company our ophthalmology R&D through would Oyster have to into of build launch of in class capabilities spray if that to

Operator

this conference will Ladies today's and call. gentlemen, conclude

Oyster Point Pharma (OYST) 7 Nov 202020 Q3 Earnings call transcript