PLx Pharma Winddown (PLXPQ) 16 Nov 202020 Q3 Earnings call transcript

Ladies and gentlemen, thank you for standing by and welcome to the PLx Pharma Q3 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session [Operator Instructions]. Please be advised that today's conference is being recorded [Operator Instructions]. I would now like to hand the conference over to your first speaker today to Lisa Wilson, Investor Relations for PLx Pharma. you. Thank ahead. go Please

Giordano, to Lisa QX Investor Wilson me Financial are PLx. Welcome and Executive call. O'Connor, Rita Relations earnings This With Chief Natasha call today's is of of on and PLx you. Chief XXXX Officer PLx. Pharma's Officer results for President Thank In-Site Communication

the the at plxpharma.com. site access also call can Web of this through PLx the You webcast Investors section of

on express performance, today's involve may of SEC. may in forward-looking with company's including statements are our a private forward-looking our Web any statements those statements be obligation noted the events remind and Before expectation, forward-looking risks as to defined in guarantees we These everyone securities to on conference filings based by these available get update call webcast required intent XX made management performance. statements release The except issued and those and disclaims like information as available uncertainties, for anticipation that be days started, the forecast, statements. that considered on belief, forward-looking future are Such PLx projection, or future to Act. projected forward-looking and materially litigation morning statements by today I plxpharma.com. Reform Pharma's as from will or future site law. PLx this Actual specifically archived our any the of regarding press would not intent the differ results

XX, then may the who topics related call the turn was recent PLx's Giordano. and Natasha replay archived discussed, announcements company's call or please with I'll benefit Since to releases held of SEC the PLx reference those November on that, so webcast, and For filings. to be may press over made the CEO, to And listening the most have recorded this XXXX.

thank everyone everyone, Good Lisa. our and you joining you, for Thank call.

partners. sNDA, launch ahead one supplemental a the submitted our regulatory tremendous FDA and to VAZALORE approved of previously targeting a year. doses the team a clinical VAZALORE for six date XX milligram These of on for supporting original together the form agency. our contains VAZALORE information requirements BE to million submitted submission considered February, We XXX to times, include manufacturing XX the for XX supplement of aspirin, The in a of end product the thrilled in manufacturing for of acknowledgement doses XXX or by results third filings drug strength confirming in a of and on part the of formulation VAZALORE milligram our timeline. and review the milligram one market they conducted October submissions announced dose for new culmination The in a and milligrams milligram results and for the sNDA, the two dose new represent off we submissions for VAZALORE the to are and CMC month those. the XXX and dose receipt submissions for for reporting, milligram sufficient announce milestone for builds information XX a the letters applications that We from a milligram basis information both we the XXX submissions the and study change sNDA FDA with currently are to for XXX bio the are the manufacturing We two are the XX submission of new company for completion supporting control recent PLx sNDA chemistry for approval the strong work a and of demonstrating in approved also The further believe the effort review significant VAZALORE next four for quarter the study formulation. both its XXX submitted equivalent officially milligram. change NDA received as supporting the VAZALORE grant allowing of the and estimated additional site and the of milligram the release the CMC the immediate

our in also happy Rita? to plan results look and are have discuss One secured $XX provide O'Connor to our the now I that we with third We CFO announce turn our Rock will Level financing. Partners. partners. led to We over strategic new Capital the by White call these million forward on financing and further quarter to Rita executing details

Thank you, Natasha.

completed quarter ended was clinical expense the XXXX, combined bioequivalence included Research recognized both NIH XX, and XXXX. of thus quarter Our in totaled no related grant million revenue Scientific. federal working expenses $X.X prevalidation batches, the prior manufacturing September study, for are partner included Things in efficiencies the spending We're and front the for periods. registration second the with batches. on from manufacture XXXX production the going for manufacturing and the costs. VAZALORE costs Fisher launch. on The planning with our year validation period preparing packaging for the for manufacturing Thermo development well

COVID the Regarding outbreak.

The are fortunate administrative to to COVID-XX as combined significant and decrease US related conferences related relates General VAZALORE. reduced fully XXXX, Thermo we is totaled currently quarter ended million impact based due to compared and that reflects supply with in We expenses it expenses restrictions. chain. Fisher and operational any September have primarily our is on spending not lower experienced compensation the in $X XXXX. travel million $X.X XX, to

in interest quarter This rates decrease to combined the on principal for expenses quarter lower with as versus for to was balance G&A expect fourth loan. $XXX,XXX We we term the Interest due the marketing. lower year. is slightly higher prior prelaunch $XX,XXX begin net the be the expense

decrease XXXX. XX, of stock. our warrant the the The period. in change declined $X.X income be liability in largely fair the company's from to will September related fluctuation million attributable price common and is value the As is The to balance in debt the of of off of $X.X first quarter million prior $XXX,XXX paid to of

warrant of a or to causes or the to reminder, compared Net million price common of change a the net liability in share income attributable $X.XX the share quarter net $X.XX of decrease third to and per the or income share loss for The per $X.X stock thus for end decrease significantly a $X.XX P&L. per from income to previous 'XX. million per of of or quarter was a to XXXX loss at end million compared primarily $X.X the was to the stockholders $X.X of third to $X of lower share. the the liability due $X.XX the As million quarter the quarter

XX, equivalents $X.X were cash cash As XXXX, million. and of September

years we the an approximately result and mentioned private of that and to issuance Level today, of shares Natasha warrants shares stock to of deducting comprised other stock the gross of million securities purchase $XX The placement As agreement of will for company Capital in White placement a and have Rock date the prior to agent of entered to share exercisable on of from purchase units sale private product for the Partners. date on per of into common million of million shares led by and proceeds before November issuance shares X.X expenses common X.X placement price placement $XX will in expire One for offering warrants or $X.XX. million issuance. XXth. exercise unit stock stock the of to and $X.XX an is price warrants additional five The up to of an close common expected purchase of per become The common will and

should that, nondilutive next existing The alternatives, financing doses we We such as cash, financing financing as back next million inventory fourth expected finance of over to to will the to provide issuing I'll turn spending call a Natasha least approximately begin as discuss at This both through the year. stock that build intend quarter. burn under will financing fund the steps. $XX may approval continue marketing $X.X approval the well and plus debt royalty-based financing for prelaunch VAZALORE. ATM. cash to review our runway to include million commercial our equity prior To launch, and of With

you, Thank Rita.

our aspirin. enormous aspirin which had injury submissions seen highly complete to and are in typically are platelet and of enteric the category, the validate than the confident in VAZALORE no aspirin the has release transform immediate to more has has pleased an data to about effect We VAZALORE. such addition with years. support that and take with novel effort few very is healthcare our risk professionals faster aspirin the and coated these, the innovation time capsule, Submissions, therapy. VAZALORE daily reliable aspirin as really of as is a way file antiplatelet XX consumers inhibition, a more complete, demonstrated a providing exciting potential filled of liquid a are think quality reduces stomach first plan. delighted VAZALORE, the ahead we to This and them us. for weeks mid-November and

provide We this are excited physicians to category. in patients alternative and an

we the submissions to strategic have transitioning planning stage the that the of commercial our Now launch. execution made, been from are

on our and focused differentiators awareness professional care in We build and finalizing consumer key commercial to continue three are and the enthusiasm At trade. the aspirin to key generate time, the same health retail category. professional, constituents: efforts consumer for our the we messaging VAZALORE's

to the as remain retail looking active all disease the into vascular in scientific closely dialog in We insights distribution. with continue of their engaged VAZALORE clinical implementing partners are gaining management We practice. our with high-risk forward board, patients advisory our they

to regulatory Lipitor for product development launch to questions. a commercialization, potential the call patients on And commercially management's names, please go much with of therapy name successful bring look the especially open experience planning aspirin and a forward a has OTC to deep commercialization needed from As VAZALORE ahead at I instructions. large as a brand with bringing the few. will Mucinex, decades agency's valuable. the PLx for name. our risk. just and successful shifts products Rx household we Collectively, Operator, focus to to become that, We With review, know experience is that such Zantac, and large

Raymond show Instructions] line from [Operator I from James. Elliot first the of Wilbur question our comes

completing just application extend been and half point, weeks, a journey to I odyssey get forward an only So a two not essentially pulling to really. to my has congratulations, by want year of couple this the on but what

So congrats to it's the long know been I road. a team.

about the talk with the side on both steps question sort the side? on bit filing given first is, clinician the financing. us the for just recent be submitted of a announced next for are to the on So the and what the trade engagement just going and now or retail little Can you to company front, you

high these engagement the So lot clinical key a now, on Elliot, patients. and continues. they them for practice, years leaders engagement to risk you know, four a we've them about anti-thrombotic top our healthcare space with the thought meaningful in as what been We treat engaging professional with with front, as the talk is

board in and alternative diabetics specifically and who procedure Some of committed that four invasive us we and events to prevention advisory be From us planning neurologists, there as our meeting will risk. meeting January. educate will, having That's may one they're be sort are had with the their years, some for different been our that their we're in scientific new that helping with members candidates therapy aspirin have through we category mechanisms, peers. for very as of a people for peers, cardiologists educate next patients, is Again, have to manage the or thing high aspirin secondary them. well

combination a we're especially that to we speak, We commercialization era. and our do it's health we professionals through and how marketplace, of learning we're things plan to working of and our And consumers is develop get And to to virtual that and of process the the in closer those more continuing launch. we'll to talk ways the get the about in what really in-person post-COVID to the as care and -- best information. platform receive constituents. COVID as Identifying during adopt some are

terms I then to first going of the this In part go trade go -- and was to of to manufacturing.

continuing we as So we meet with in and trade terms them speak. the the are to retail partners, of

their within to as segment meetings scheduled, we're wins. wins, The ongoing retail systems distribution own wins to promote going company have on meetings because how We certainly partners patients wins. then and everybody VAZALORE partner the

what going standpoint. those manufacturing And are ongoing other discussions little bit very in a about this from support we to launch. So to have becoming we're talk each a do are that on Rita how can then very, detailed

this year idea why we're then So our coming very inventory. start going us with early places next next good a if already ready mentioned. things go all have plan the are going building well, as to We're all that, we where Natash for inventory goes later retail into they're the actually. well their key we in, build and And That's then right now, validation steps into was financing pretty this could because to and to commercial and orders of go, trade we when year.

So be to to go. we're going ready

deals this that initially of targeting support? large of invest And time? there chains distributors would fit some in point actually I what the at be that, you much share sort follow terms you retail you in would point that the financing some larger within plans, you later on are that of or your of of mass how launch just kind expect would be any of something and initial could the to launch inventory a mean, at or would levels just actually in

drug that mass well assuming we've that recently, targeting speaking been nationwide stores chain we're we've to in So including all And top it's everything for merchandisers. is and actually ready retail going years, now terms we're the with to the really a submitted so as be go, as trade, of them launch.

inventory it's be country. this going have to a around lot because it the shelves to on retail the So of we'll build

approval forward I talked additional approval, with gotten to haven't fund it we we actually of that's schedule, million Natasha plans $XX And a since portion of good once orders. receive put dollars commercial that But of ahead or move should the we'll we final that se help ahead some their about. the target of So will per inventory that all financing then haven't say. when to

there feet question of owning flexibility used think how thinking in kind have sort mean, wondering Still being have launch street launch be commercial you've wondering of much of products last to for of sort in I of terms seem successfully to rep-driven having you successfully for the outset. establishing the How your terms talked detailing planning about of importance product. that some being leadership time the from here Natasha. you're that of the with thought the about some then to to terms sort of you in reps. you're of this the But original launch a infrastructure out quite kind And plans on if tools of product? of kind given on new necessarily a without companies onboard able

of approach. well. our it's So We of that partners. the in done we've cardiologists require research a different this as yes, with and to done with that still We've lot environment, going lot critically a it's believe thinking the important And COVID to neurologists. a really to get

scientific different our utilize board as absolutely vehicle will a We advisory mechanisms. through

into publication So community things those and into as that are conference to are for manuscripts get we appearances speak. instance, very presenting evolve our key in abstracts strategy, our the and are important all progress cardiologists medical

to be ways how the to pondering far we there do are partners small, and I ground, As with with new approach. that want reps ahead to the our can evolving. feet how assessing what as best absolutely good change. big QX on professional is this are launch front plan innovative of next they're combine get But talking we The best platforms we the that in where to manufacturer, there's adapting our think for thinking in And is those been healthcare and going There's reps. care face-to-face that's year. to are And of that on will news scheduled And we our mix wave what likely, have that virtual most evaluating of potential address to of you for and a provide mix are partners and with professional. that. is, we information every some the the market health the that, to get and

Securities. question show Butler line our I Jason the next from from of comes JMP

in they've First with a But off, and just of manufacturing pre-approval progress since expect can, any the to FDA dialog sense color, the if applications you they're Obviously, you the expectations, inspection? your on submitted. just do you. were any responded making

them FDA, with we interactions I regular they like ongoing. what require pretty thing One on CMC and I'll to the as aligned have that know, say, supplemental with on in as been both Our doses. NDAs have say, is you the always

gives us in need. we they have very so high that And confidence will that that everything submitted

have very review estimated date of completion we from the February. that so heard And an end of have recently they them

need to course that's other give the question, very to to questions everything high degree of along that Now way might say the approval, why But that have all provided Rita. a ready approval they And of may any have. we're will four always say have of to the I'll that they confidence part for we've we questions six get they expected we I'll within months. is and again, that

The Thermo have manufacturer a with great a FDA the One Fisher and record of of using GMP. scientific, thing track compliance Patheon, nice well-known division is with very they a we're

So we're entitled inspection. do a to hopeful that but confident that it's entity, But aspirin. not that chemical an new it's it, waive we're they because may will they waive they are

they inspection, will I waive US we're be that US which little will with So there’d inspection, this understand, And than this a better inspection. timing a at with hopeful they time. foreign are be it

just the would it plant. be So Cincinnati

chain now the a items work obviously, key And launch, lot post-approval can both Just XQ doing done to you'll what from the needs talk the about But to date be gating then a be perspective between and of to you as manufacturing approval. and there's approval well? supply from launch?

is manufacturing. hit as there, on you big is head, the thing the So

the an the label. actual our Rx of is package product, product package, unlike the So carton and

we other very label, trying approve there. similar you have at as also we're aspirin. carton already as were the language to all confident changes mean, print approved risk. pretty on They here milligram there's but XX And it's that well still can pretty labeling has than imagine, to insignificant. the a I XXX class that made all So few our FDA for

that want enough think don't and that you we big to sure we but manufacture not it's a we have too dating make So advance a in issue. risk far

product. out typical So OTC months we're is for XX an anticipating going with

early clock So you don't dating by want too and it. to that start making

So we want sure to it make timing sufficiently. that we're

So between launch. balance certainly when we approval a receive it's of and

to that to building enough not a it of manufacturing related but too So time mainly, making is early build enough. lot and

Giordano, back Thank like the closing questions the call in no I'd this to And Natasha further show remarks. at you. turn and I queue. CEO, to over time, for President

joining you. thank stay an evening. team, like sharing healthy time exciting have PLx I’d confidence us you This and for future Please process. updates. Thank partners Thank support And this for this PLx. great our is forward and throughout for a safe. to We look to and the their shareholders evening.

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

You disconnect. may now