PLXP - Earnings call transcript Q1 2020 | PLx Pharma Winddown Corp.

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the PLx Pharma First Quarter 2020 Earnings Conference Call. At this time all participants’ lines are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to hand the conference to your speaker today Lisa Wilson, Investor Relations for PLx Pharma. Thank you and please go ahead, ma’am.

Lisa Wilson

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

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

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

filings. so archived replay have please May discussed, the most this may XX, For the may to then, listening is or and Since press PLx releases company’s related the made the webcast, who held benefit of SEC recent recorded XXXX. those call reference to announcements and topics on be

CEO, the to PLx’s will call And with Natasha I turn that, over Giordano.

Natasha Giordano

month call everyone our you morning, since dramatically Good today. last the in and our thank Lisa. world call. earnings has you, changed The joining for Thank

our us as We has in all family lives. professional shared in are adversity that our of affected as lives facing well

and appreciation our serving working affected thanks to everyday by out deepest go COVID-XX our all hearts communities. to Our and everyone

ensuring During novel regulatory these product our to in and continues that our remain advancing VAZALORE process. the we challenging aspirin through times, steadfast and commercialization commitment to progress

discussions to As will supplemental for milligrams to our the end a last application, new quarter, you the with study bioequivalence from held sNDA. meeting for XXX VAZALORE VAZALORE drug recall FDA a April, or conducting on support the XXX BE of Type a At may be our align study design we C milligrams. we or

required awaiting which design. currently We the confirm the meeting, will are that minutes study of

and prepared engaged once We have study are conduct work with FDA. to the the BE requirements commence are the the confirmed CRO to

Assuming no FDA COVID-XX doses related targeting delays, milligrams and year VAZALORE milligram end the filing for the submissions XXX VAZALORE by XXXX. XX we are sNDA both to

previously and will our financing voted later by addition, Partners announced stockholders today. B preferred on $X MSD Park convertible stock million In West with Series be

to largest and are new with We our excited our continue partner stockholder partnership Park West, our MSD.

to I CFO, quarter will first call the O’Connor discuss to turn the now Rita? Rita over results. our

Rita O’Connor

prior year will which ended to the XXXX. XX, the Institutes Revenue be both quarter coming attributable the from of Natasha. for period. recognized you, to revenues National work X to $X,XXX end of Thank March $XXX,XXX a of is XXXX federal of performed in the in an Health, periods compared revenues under months grant for We second

the $X Manufacturing-related second to also This in production required completed the prior this are left related continue sNDAs expenses months quarter. and of lower capital we commercial decrease quarters is year million in three XX, point validation and and $XXX,XXX in for stability as ended NIH Spending development required grant, reflects are $XXX,XXX March the period. in the the for the completed spending working quarter submitted totaled in start the decreased testing. expenses versus which until we Research prior after to the registration XXXX we obtained. reimbursable and patches continued have will submissions area additional sNDA on at be some

Although third quarters plant later we manufacturing study our to BE spending will as decline, and the increase second spending this month. begin is overall R&D anticipated in

administrative and few expense expected developing consumer such as the for as General at $X.X on planning in totaled next ended compensation. pre-launch The support. remain stock-based XX, VAZALORE XXXX merchandising months is due selectively the million retail for to quarters and three current professional March $X.X increased compared expenses related levels first activities and million for messaging sales G&A the and marketing spend quarter. we is primarily trade increase in non-cash pre-commercial XXXX and to to activities

warrant million of warrant expense the other in income largely in comparable change in to X income XX, other in March liability expense $X.X due compared change months $X.X the liability period. ended net primarily to other Other of the net price prior $X.X the XXXX of net the XXXX the to The the expense period. company’s the the is change compared totaled This income million of year fair million fluctuation in of common the XX, in ended XXXX other attributable is stock. months of non-cash to of value March million $X.X X

rates. to $XXX,XXX due This Interest million term and balance principal first was for of and off is as paid combination from quarter expense was loan lower XXXX. balance quarter loan the other first of principal to expected This loan of $X.X period. $XXX,XXX, million the term prior $X.X was a paid down XX, decreased the in lower March our be our interest of ‘XX XXXX. on which The of year to

stockholders Net of diluted for of $X.XX share share income million and $XX.X million or the quarter $X.X first XXXX. basic per per for compared of to or XXXX was $X.XX to loss net the first quarter common attributable

the XXXX The in $X.X to or change $X.XX liability. related first a $X.XX to non-cash quarter of a share million first share or gain non-cash the of loss quarter of ‘XX. $X.X All in of per warrant the million compared per includes

related preferred stock A Series to per XXXX dividend. of quarter first or The included the $XXX,XXX $X.XX share

quarter dividends Series the While XXXX $XX.X the A beneficial and in per transactions $X.XX included completed share to million the or for related of preferred February XXXX. conversion feature first stock

last will As entered price with X,XXX at conversion proceeds preferred purchase Asset we shares convertible and of per compounded will in X% gross for sNDA approval $X stop and are per $X.XX be payable the to to quarterly Park at PLx’s The and dividends of stock preferred $X,XXX be initial B of West stock an agreement stock shares the annum, milligrams. Partners on the for million. The MSD quarter, will or of dividend share issued of convertible into purchase Series the preferred the FDA which into of per of date cash common Holders will discussed entitled rate and share. preferred be XX option. VAZALORE at XXX a stock Management accruing

cancelled While warrants stockholder we issued approval. financing, warrants along are upon the with the

for filed to is transaction today next related scheduled will approve week. meeting the stockholder the results in Our to included later be and X-K be an

to raised the timing of of The of marketing financing level need runway stock approval and million provide capital As of will pre-launch commercial equivalents $X.X were for the of submissions financing million cash cash second determine the XX, Series million. preferred The VAZALORE. of additional XXXX. cash burn will the cash spend and build the the submission should company $X.X quarter into sNDAs, of with the $X B the XXXX, upon prior and amount March quarter inventory of

is quarterly be cash million expect spending to the cost burn to lower as with closer associated $X We with manufacturing study. replaced BE

our to in supply product significant Ohio impact outbreak, to that and have VAZALORE. not we operational we chain it Thermo are fortunate operational any other experienced COVID-XX is Regarding Scientific functions. fully or as manufactures currently administrative Fisher or relates Cincinnati,

over so can updates I about our additional activities. that, Natasha? share With to turn recent call will the she Natasha, back

Natasha Giordano

Thank you, Rita.

forward process. final regulatory of VAZALORE completing looking to requirements to are through support We regulatory steps the the these

address demonstrate the FDA C the Our all strong discussed. the new the design VAZALORE approved Type formulation minutes to April The we of goal submit will from requirements FDA’s is our study like meeting and that confirm that requirements performs of formulation. sNDAs

of study understanding preference we conduct study. We have already FDA’s the to a and have engaged design the the the good CRO a on of

Assuming the been once details we there due significant all plan to are with have COVID-XX, delays to no confirmed FDA. begin enrollment

we Let VAZALORE’s market. about reliable complete the anti-platelet than effect faster key coated reasons and VAZALORE summarize a are me aspirin has more potential confident enteric to transform demonstrated the aspirin. platelet more briefly inhibition providing

As capsule, aspirin the filled the it addition first aspirin liquid is a to truly category. novel

as Our target market procedure require had these includes secondary aspirin vascular prevention. need therapy. long-term and attack, treatment a heart who stroke patients. patients a of people who The foundational for or known guidelines also patients as Those vascular a

whose initial doctors diabetics a at higher market of event addressable therapy. includes having vascular aspirin recommend and Our also an risk

people in million more Today, $XX a patient groups represent United these together retail than billion and XX market. two States the potential

across to that action in global large that providers to to These comply central neurology, healthcare VAZALORE’s continue We clinical at specialists medical to well typically conferences encouraging are and impacted robust cardiology, understood. treating the profile role clinical them attendance and these VAZALORE’s engage a gastroenterology with COVID-XX of recommendations. and profile. showcase will many unique have patients has of we live with attend mechanism ensure

our upon conferences virtual have presentations. to many these education continue converted of strategy We been medical publications and to execute as

data benefits lipid in end, XXXX Over aspirin In The of treatment VAZALORE, International fasted couple to and growing dedicated of to published To at analyze entitled of an in novel presented meeting The of a improved bioavailability understand the absorption was disease. Stroke to including aspirin of complex and subpopulations. of highlight cerebrovascular of simultaneously poster seen states and February, amongst the fed we science the universal have and A a accepted Journal pharmaceutical and Conference. interest Thrombosis that we was years, study across the the formulation Thrombolysis. premium our clinicians. original sub-analyses and in bioavailability better last continue various and aspirin

Cardiology’s end of were abstracts that at showcase the College of American two At VAZALORE of the original Scientific advantages Virtual Annual Session. presented important March,

with studies was pooled Dr. two aspirin over patient presented and enteric aspirin, The Harvard pharmacologic profile Deepak improved Medical Bhatt enteric by of as poster a a moderated described Brigham improved crossover the of School. Women’s first compared aspirin level analysis novel the Hospital pharmacologic coated profile liquid and and coated entitled formulation of randomized

a coated weight crossover entitled The effects of comparing the liquid pooled two on a of aspirin analysis with of randomized studies aspirin. formulation aspirin second enteric anecdotal results impact abstract of

Assessed the patient prestigious important discussed an abstracts of enteric society European conference at cardiology highlight qualities more global we unique cardiology that VAZALORE’s accepted leading is and we which in have two two for largest the aspirin and ECR presentation These and conferences weight negative us conferences the world. response are to pleased field for experts mitigate the Europe to bioavailability weight the with the coated impact the of in opportunity increasing on in aspirin efficacy. to offer to engage

regulatory Let them to aspirin the With that, to who market. sNDA’s healthcare order priority by is remaining stating the a go this innovative highest that submit please I me to formulation delivering questions. conclude can the will we vascular professionals benefit with call and to yearend bring requirements for to the Operator, treating the VAZALORE in and the patient our ahead FDA of novel help instructions. excited therapy are to complete our by millions open from

Operator

Instructions] you. Thank of comes James. line Wilbur first Raymond from [Operator with Elliot question Our the

Your line is now open.

Elliot Wilbur

in package, receipt agency, guess Good significant thanks. expectations forward path, your to any of for companies XXX and want bit realize And particularly the about there better for will plan from is that the of the I prior make the or old that I detail then always but perhaps deviations I investors of path their to around am enough is with to morning. respect the were same a a the the question submitted meeting, us give enough sure know this the ahead quite I – be that long simultaneously fact actual down or Hey, that minutes I interactions basic not going XX to is want VAZALORE? in correct? have aren’t or to of so with surprises the guess

Natasha Giordano

Okay.

question. first your take me let So,

We and design. study our the late addressed many with the FDA bioequivalence April, specifically interactions meeting have had in

And what understanding require they for so good we prefer have of what the a sNDA they filing. and

across. within typically shortly. come days expect However, was I minutes April, late to come meeting. meeting since minutes we do want meeting come it to wait until of XX They the the those And

so submitted filing for be filings, the we milligrams XX and in be shortly will of parallel, submitting sNDA terms then milligrams, thereafter. XXX XX two In and milligrams but XXX will

Elliot Wilbur

but themselves perhaps And announcements what BE the that, current around the about data of minutes wondering Okay. perhaps get are as follow-up those or actual detailed then that, sNDA so studies just of disclose am the data the to announcement what actual obviously around announcements about commencement in quick not might going post to details a advance of points just is more the thinking of I them, with we you thinking completion of in milestones? or at least the thinking submission. maybe your line a or

Natasha Giordano

Okay.

We release good that that to what disclose the market Elliot, submissions and you, what we the will end the do for of understanding I to year. with have quarterly would have continue this require will FDA is update but for targeting we a of certain, every the factored and into our say

Elliot Wilbur

have any potential partners just has bit wondering question there side, about sort a position been quite are updates sNDA of in to ability engaged is retail disruption kind the you with ongoing order Okay. which just submission? what you last to Thanks. your had and to the actual launch And of post are down just still best possible them currently able commercial activities conversations obviously road, on the of the with maintain in stay for

Natasha Giordano

live, managing are bring and yes, Steve you, as continue, they of held Valentino, and has engaged been meetings are and and Thank to conversations meetings to Trade to our meetings continue Well, those market. those They certainly Vice be partnerships eager not we Elliot. VAZALORE virtual those relationships President continue. much as are Sales, being but

and good So, we updating we with pretty to feeling conversations do having market. the are we as them about them are

Operator

you. Thank

the from with Hong comes Esther Your Janney. of next line question

line is open. Your now

Esther Hong

Hi, good question. my for Thanks taking morning.

any timeline other So, filing what stability an activities the filing submission could – the of bioequivalence pre-launch next what we XXXX details of potential than steps from can the approval decision? completion expect launch And And then, to Thanks. remain to U.S. study remind you then sNDA prior of and place, on potential filing a could in with that? additional terms studies? year, approval us when in the take

Natasha Giordano

Thanks, Esther. Good morning. Okay.

Okay.

filings? So, are question what to already the or the take was do need CRO. bioequivalence steps need And we indeed We engaged the study. have to first the we do the to execute conduct prior

together we think get this filings, very We soon we FDA. the what the makes work to alongside those that two we are the as meeting into that filing of commence That as ready manufacturing for will fill the confirmatory from data strong the minutes portion a elements is VAZALORE. CMC what is

the really So, two we those that to accomplish. need things are

the As the while for far as a we CMC portion that of filing, have been working on now.

together confident So, very a come I everything will package. sNDA we are that anticipate strong nicely and that will submit we very

In a well. this we will continue provide but bioequivalence CMC portion we as supplement, approval, terms data now believe also to to timeline the is the where of only the CMC that of filing, not

give our So, We PDUFA to approval pre-launch? respond professional to constituents, timeline. but publication continue committed continue are launch three of to healthcare the with major for the partnerships we are consumer. to retail this plan and and on we expect are and the review do X What to wait their believe us in that for to much continue FDA, will the to to medical building going be build very period we for on to this the of we strategy, a that right our will which and always course education X course, FDA month target focus

that that those the our messaging strategy. continue submissions consumer But three commercial for and will We put three the additional commercial been level course we the also typically we will main are the around need of those of working plan. financing across we our but secure areas, and to professional will have pillars areas will dictate spend on and healthcare

Esther Hong

you. Thank

Natasha Giordano

you. Thank

Operator

with Our Thank of from you. [Operator line comes Instructions] Jason question the Securities. next Butler JMP

Your line is now open.

Jason Butler

Hi, thanks I the questions. two. for have taking

like, can And single is of the – think Just as as think considering Thanks. are of then from multiple pandemic? extent that impact virtual about COVID and the you first on you or to you one long-term a education you how question diversification now e-education changing multiple it have impacts that tools suppliers? about just you what how And healthcare diversify think etcetera. about you supply – pandemic sites second that would the site, to provider talk already chain, is long-term been

Natasha Giordano

Jason. morning, Good

even So, leaders having key longer in being skipped virtually are impact, the held in our not have because terms we will saying that with term many conferences a by our of in therapeutic Advisory COVID I these and comprises of space. are which thought Board, terms of education we plans, Scientific the this meetings start and all really beat medical

of that get well. fundamental the our links explore venues and The continue specifically. has strategy, the been e-education and a planning but is key we neurologists consumer so as aspect always strategy, new of and commercial to will it to part our retail cardiologists to terms of how education clinicians In and education of these with partnerships

are factors. we exploring of So, all those

In terms chain, answer that. I will the Rita let of supply

Rita O’Connor

Sure.

our question In for as in have a capsules, are operational a diversity, now, the it’s one have enough is been right but that supply as now. fully it about. U.S.-based, this terms and we supply single Ohio of have during manufacturing always time we chain right our great they and ingredients of key our it’s and I team well And Cincinnati, of site talking it’s

suppliers. take always, as However, it’s issues, always a of look these some good backup at to

costs our our of you different to as So, well once lot suppliers raw money, our to both is long-term little it manufacturing that that supply and diversify difficult some but with as of sites, can strategies sites imagine it’s a validate a materials. one

Jason Butler

the Thanks Okay, great. taking for questions.

Natasha Giordano

Thank you.

Operator

today’s question-and-answer remarks. closing call conclude turn to Natasha I the session. like does back to for this you. Thank now Giordano And would

Natasha Giordano

to Thank look updated to time through to you advance to as aspirin market. Chris. VAZALORE the for product regulatory morning. we this this prepare forward you your continue and process you, We keeping transformational bring Thank

and During day. have remain a these great challenging your and you safe times, we hope families that

Operator

and gentleman, does for Thank participating and disconnect. this you Ladies conclude may you conference today’s now call.

PLx Pharma Winddown (PLXPQ) 15 May 202020 Q1 Earnings call transcript