PLXP - Earnings call transcript Q4 2020 | PLx Pharma Winddown Corp.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Ladies and gentlemen, thank you for standing by and welcome to the PLx Pharma Fourth Quarter 2020 Earnings Results and Business Update Call. [Operator Instructions] I would now like to hand the conference to your speaker today, Lisa Wilson. Please go ahead, ma’am.

Lisa Wilson

Thank you, Victor. Welcome to PLx Pharma’s Q4 2020 earnings results and business update call. Investor PLx. Wilson, Lisa is Relations for This With and O’Connor, Chief today’s call Chief Giordano, President are Natasha Executive Officer PLx. me of on Financial Officer and Rita

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

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

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

Natasha Giordano

today. everyone you morning, Good and us thank Lisa. you, joining for Thank

the XXX work approved we supplemental the drug announced XX VAZALORE, new platform deliver hard for past the experienced It be develop patient, And been overcome has innovative has need medical that in years. always launch has we a can FDA are and our now, delivery to the and vision our realized VAZALORE we over milligram aspirin aspirin this on the proud platelets. third of we taken Having top uses first both aspirin the and of dose inhibit drug. therapy the to excited to several milligram strength the to predictable years therapy liquid and few capsule. filled patients challenges drug As applications our that are that the dedication of and lifesaving X, this those only mind, to motivation quarter to March who reliable very the to community PLxGuard proprietary

demonstrates the predictable VAZALORE the the yet, current and standard published most reliable widely clinical straightforward. has enteric-coated in proposition in ulcer been care, established category for in that is addressing valiant risk observed limitations platelet used release opportunity for VAZALORE in aspirin erosion of commercial us. trial. no is is than the decades well and large the Aspirin This significantly immediate aspirin thus in our inhibition until stomach world, of reduces innovation The now. drug absorbed tract enteric-coated there GI and the is radically the fast, aspirin. and VAZALORE as It’s a been of

about therapy. candidates as from for event or $XX were market and aspirin thus groups, both those vascular suffered market attack heart stroke We high an diabetes for will already at with the an who than in transform million such the VAZALORE of maybe believe and retail standard the having risk care. XX event those defined two more patients at With like estimated billion, with this have includes disease,

of Scientific extensively of and we XXXX, over-the-counter quite published world in clinicians made And into unique Angiolillo. potential in guiding for finally, of renowned XX delivery and for mechanism Scientific our understanding up of our experts the The neurology esteemed have product. the to important serious strategy and Importantly, gastroenterology, by an disease. Isaac shared Board VAZALORE extending reason VAZALORE’s the novel is instrumental patents is cardiology, to is what’s and excited Board Advisory unmet treat Bogoch Dominick to been need and vascular have Drs. address Advisory a

call We institutional of interest our of and over are with investors. our Rita O’Connor, public to CFO, turn a thrilled discuss offering existing I financials. $XX substantial stock Rita? that will we million new both amount recently closed from common now a the to

Rita O’Connor

the plan. as Thank you, phase approval Natasha. I commercial move of enthusiasm into execution our for we like would our Natasha’s to echo

for First, I cash XXXX. discuss the of flow will the quarter fourth

of XX, inventory shares of burn pre-launch and used $XX.X an million cash November, company fourth the our $X of price cash million, deducting with company public. placement the we of closed cash to marketing operating XXXX, expenses. proceeds had at $X.X before stock that Last commercial an other and materials. a week, underwritten secured of approximately $XX and be of In As build primarily December Gross for to private on quarter. the common will to million discounts equivalents million underwriting offering were public X.X million a the $XX we prepare

$XX least million, this We sufficient VAZALORE for years. execute the activities be our at next our for of expect X cash net million should proceeds, $XX commercial existing plus to of

Thermo busy validation inventory commercial on quarter. our with in in production very both Fisher and the completed for manufacturing batches We partner, began front this We too Cincinnati. doses been our have

retail have this to supply inventory stores country to expect across We summer. the ready sufficient

distribution We quarter. we loan second we I continue the term on will final and for cash the $X.X spend. the our manufacturing be will burn details from of as of of we as prepare to commercial shelf to the are will launch With increase placement over share purchase as we and that, expect sales call activities and received build and Natasha. on million in sales VAZALORE turn and continued back the activities. cash around third inventory the as ‘XX, closer of In our we marketing to and launch well $X to for quarter the million payments marketing Once to more increased commitments burn first retailers, quarter our made ‘XX

Natasha Giordano

Rita. you, Thank

We announced the last are FDA we of week. extremely proud approvals two

As a of we time the sites conducted, new new chemistry the considered aspirin, change further align manufacturing for to on bioequivalent XX the results or dose the milligram The reminder, require in in meetings and VAZALORE’s submission release formulation, supporting for understand as the control, also for milligrams dose for VAZALORE NDA XXX the XXX built milligram the for and two of in sNDA filings, took FDA product series immediate formulation. included approved sNDAs dose. what the completely XX the information they manufacturing The they to These contained were a VAZALORE milligrams. the original to with change those information submissions. for and strength XXX submission the clinical milligram with submitted study in the the off demonstrating CMC

as basis submissions doses for than All the for their information agency strong two by evidenced of both approval this the to formed earlier expected.

depth team turning involved approvals successfully our launch do and and Collectively, a HCP Now, their Mucinex, name. FDA how best, with understand make we and Lipitor, clinical highly decisions. successful relevant launched management been experience This PLx VAZALORE mega the has team This leadership launching hand, household buying products forward we that successfully Zicam, what just VAZALORE. We practice challenges as brands OTC excited to names and do segments across build to the faced consumers products. name look in to few. has the Zantac is of to prescription is a is and in many team into launches in household such the of

experience also more months to market in of COVID. the We The past XX world, U.S. dynamics. customers with this it’s virtual now In retail have has important channels. leverage certainly evolving world intricacies with trade and this the extensive understand changed distribution

consumers. specifically and plans focused launch commercial and Our are professionals, retailers healthcare on advancing

management central strategy data. our and stakeholders raising of forward its and mechanism look supporting commercial represents FDA-approved for our and filled depth is aspirin focus clinical as delivery about informing and retailer VAZALORE and closer as data, the Additionally, compelling capsule, information questions. launch. published launch. the with our liquid call go With unique We our Operator, on from first marketing community, get successful please open firmly the that our commitments combination believe a plans only this for we more team’s of three sharing to We awareness, experience support the our the the on clinical to that, ahead will educating winning to consumer a I instructions.

Operator

James. first Our Elliot from Wilbur Instructions] come Raymond line of question [Operator the from will

begin. You may

Elliot Wilbur

Good morning.

my – last but as obviously a think VAZALORE sNDA. what follows completing well. I I the you Odyssey you resubmitted Odyssey, an on congratulated sure am maybe, the pilgrimage on not want I just when to in I So approval call, congratulations

little not launch plans detail just talked there will in that of while and physician us an with a I you force the given in obviously, effort or has the as since outside maybe timing? and strategy primary you fact share about may additional first, So you initial maybe remind then primary Is you Natasha, pandemic us can what numbers that of ground, initial about? will the maybe it’s but this more your have considered beyond I you initially, strategy just the initial having question altered anything who got hold off been thinking respond. have How detailed until maybe launch primary maybe point the be you well, ideas just with a respect the to call plans cardiologists, on sort terms of about but at thinking audience? have And detail previously, in

Natasha Giordano

Okay.

loaded. So, that was

let as question. me say the unpack I So,

First of all, you. thank

need FDA us. market patient this capital really so are does do to management with launch excited we beating huge the is about a need. The addressing going two central really team. to that to very We we efficiently It having impact drive product. securing our then and the successfully make approvals serious for unmet this in important very believe this We are

certainly not you are is online, picking that buying of in our so consumer the all only more cardiologists, business, the store. stakeholders pandemic, changed COVID up has the the way And raised doing

we And Amazon. we be need year, retailers also about the spoke, So, was is. business. up that Last to it when consumer that, built everywhere their e-commerce have

the e-commerce accelerated all platforms. have retailers Now, top their

that so into And course, incorporated of have strategy. our we

to us. resources way, balanced generate allocate enabled to it and And did now three all trial. our I inform very us enter important in we what patients ever, are because really very a more awareness, stakeholders get educate was than need this and think to

well. multi-channel, with doing the search, in and approach. to to we’ll we’ve as but So those very be extending towards words we’re a ever, will in now more digital, before, And media, in that, COVID, going integrated than much things be said that doing HCPs way be

using think way. personal broaden I be all be because a even the us before, I the on and that more ground, virtual it though our very and will know everybody promotion. going in put that not to non-personal obvious that We effective course, to for reach to that and products it’s numbers understand there done is And going want way to will of we’ve for that, launched to reasons. our we’re how I’m that And going many out enable people with HVPs? interested share is

professionals sales is through I entail generating they strategy. what very laser-focused practices, that is very on are those volumes you different and deep developed tell may and And we our yes, which – we have several cardiology essential However, group will to practices. cardiologist the plans in our will plans

are looking we and got very closer, hospitals, into are are the also that and all well. plans integrate U.S. I interested you that as in hospitals heart top know We in And the some detail. we’ll more stroke at that as that our

we’ll we we about the talk get launch. As closer closer, to as specifics you to get

Elliot Wilbur

itself. then of And to on another I – you specifics launch question the wanted around Okay. ask the

maybe a being So third hitting initially – across retailers. retailers locations? effort with Or be provided shipments networks? But quarter, to limited should retailers, a initial respect but all their are a we or of their not with to about thinking should broader launch number thinking all about to obviously, of kind supply we strategy be phased we just timing, entire of launch stage

Natasha Giordano

to plan What are stakeholders. deep those planning very very three we is a but balance, reach

our and expecting approach. HCP the are the ground hit and very retailer uptake much want with phase consumer, X this And as no, to product we really not this the as plan. to a through So, the in quickly a as day We get unique launch. national be can and we

no, not approach. not – a So it’s regional. it’s national It’s

Elliot Wilbur

question Okay. And here. then just last

be presume VAZALORE for I expense, paid will you terms know a patient that covered largely under aspirin Just ACA. of category in are thinking the that anticipating out in of pocket. is

to formulary so term, gain that you Just an could there the favorable be is actually think, more longer maybe covered? product wondering opportunity eventually if here positioning

Rita O’Connor

Rita. It’s Sure.

at this covers launch approach that is pocket. managed right. is right, generic yes, of all certainly we’re the that, and be There launch, for you’re right could, as market aspirin. But So I a modeling rolls ACA it and ACA. will care now, out, really we mean out

So show – some to which work really at improve just know targeting but we’re we value would have launch. we do can VAZALORE, to that of do, the we not audience

Elliot Wilbur

Alright. Thank you.

Operator

line next Securities. Our from of Jason the JMP question from Butler comes

may begin. You

Jason Butler

thanks the well. And approvals as on question. my Hi, congratulations the let for taking add me

Natasha Giordano

Thanks.

Jason Butler

When we Will launch? forums? rollout? could education that be Can that Could to you ahead me DTC could – of start? you’re peer-to-peer the sure. using see activities to start talk doing educational be the about going When of you some you campaigns

Natasha Giordano

Sure.

and to key our few plan all and so conferences in communication education, strategy in virtual we our essential continuing a a We’ve is obviously. for VAZALORE in been cardiology even to launch way. the marketing do So years are participating and top now,

at strong ACC have a will presence AHA. We and

for as is wrapping educate a also And important really and to that, we are with the they important. those strategy me who is very publication cardiologists up listen publication We how for themselves cardiologist, plans knowing speak. extremely

principal converted really post published from that’s study General we launch. Angiolillo posters o of are to but study journals of year, submitted that a Dominick also do and Bhatt, published the to are all gastroenterology. spent publication, in of very things our way, we review its will our about pre-launch of track, Last These fact others. we So top be have up proud on the different College conferences, keep talking abstracts committee important. the that peer journal cardiology of the made with led publication our will manuscripts and certainly into investigator, for Those by been data. American like the number also along data in and Deepak continue our and investigator

secondary see potential and physicians. media Our do influence. consumer, is raise drive a the familiarity. also cardiologist. about patients, also for to campaign, number specific aspirin therapy the they maybe really the need to to convention our That’s is know What awareness candidate to consumer one patient brand They their the address diabetic consumer, their we that and listen and to have

that see media during will campaign QX. you’ll our centered launch the around So be in

Jason Butler

you great. the a helpful. guiding the Okay, of And cost you’re then know out the the of quarters manufacturing be in That’s Rita, terms in not But sense occur XQ of that rest Is the will that going I for give and us the can for in through spread year. year? earlier just primarily inventory or three remaining the to build? year spend

Rita O’Connor

They quarter, bigger third Pretty third up. quarter. go will goal to much I build. will the the and third the ones have summer. to still marketing then burn the is in But expenses second mean, the cash inventory as it quarter this them. be But still of have we’ll sales we we in our go quarter, ready get on the have into DC the And

spread So helpful? be it second inventory, quarter it the and that fairly in should second. be sales the third heavier in will the third Is is between and and than in marketing evenly

Jason Butler

you. thank taking helpful. yes, great. – for Okay, Thanks Thanks

Operator

next Our of Instructions] the from [Operator from question Leland will line Gershell come Oppenheimer.

begin. may You

Leland Gershell

thanks congratulations questions questions and you accomplished. everything of to and wanted Natasha Rita, a my morning. couple I good have ask Hey, on for that again my taking first.

users to wanted may opportunities to maybe the back be program customer terms kind very I about a might on that VAZALORE? ask ask what but being thoughts wanted facilitative VAZALORE loyalty just time product, product? in like then product for U.S. of of coming OTC also kind And some of to consumer-driven the end Thank a away, for your stay you see ex With you.

Rita O’Connor

the So Natasha first international it’s on question, question. the Rita, I’ll and to I’ll forward take

on top big very are stores drug loyalty retailers especially customer the customer programs a programs. lot loyalty of have actually, yes, So chain their the

them all So that working we the loyalty programs. to drug of for And customer working have launch VAZALORE. years best does and with actually been several with include stores on now yes, chain those strategy

significant reach. to our plan that use of a we part So channel as

Leland Gershell

Okay. me. all That’s for

Natasha Giordano

in to And to discussions the had and millions But physicians is for we absolutely vascular we key, can open U.S. disease. is patients the we that are that a of huge primary make end, as patients have great product patients with this because right, are that this our have And some help expect manage success. that area. possibly little high-risk we opportunities focus in real a many as help

– we so our priority here. launch And to is

yes, However, as X this scientific who is last board. as in presentation board have published an With in on very cardiologist years. opportunity. Gabriel and participates in fact, well we our our advisory He for that’s scientific well. And always a world-renowned today, category advisory the

So, yes, regard. discussions there that absolutely is in

Rita O’Connor

And are in a lot our world European well the also, and all as markets. big over Asian the of patents

patent have years. protection a lot quite for do we So, of

Natasha Giordano

Thanks. Yes, good point.

Leland Gershell

very Terrific. luck. good much excellent information Thank you and for the

Natasha Giordano

Thanks.

Rita O’Connor

Thanks, Leland.

Operator

you. Thank there no Natasha questions turn further remarks. back call queue. over the for in I’ll are any closing the And to

Natasha Giordano

you your Thank you. this morning. for Thank time

approvals hard the and of risk these a We our for are will PLx thank and partners, the all for the in have to sincerely and and team. launch continued work safe, management the transform believe for shareholders Stay capital VAZALORE and We their two our healthy critical care the appreciate day. to support VAZALORE. dedicated vascular confidence standard of millions great excited patients for at milestones, We disease. achieve needed so FDA of

Operator

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

You may now disconnect.

PLx Pharma Winddown (PLXPQ) 12 Mar 212020 Q4 Earnings call transcript