PLXP - Earnings call transcript Q4 2019 | PLx Pharma Winddown Corp.

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the PLx Pharma Fourth Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions]

to Investor conference Relations like today your now Wilson, Lisa for would hand to the speaker I PLx Pharma. ma'am. ahead go Please

Lisa Wilson

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

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

Before on that to forecast, Litigation Reform statements belief, by we may future would everyone remind performance considered like Act. projection, future regarding be get started, defined today's the I forward-looking events Private that any company's as and anticipation, expectation, express Securities made or intent call the conference a statements

forward-looking filings the release materially on are of in future and available from involve Pharma's those may guarantees not PLx forward-looking in this and those issued performance. forward-looking statements. based morning our today Actual of differ the to with noted management results uncertainties SEC. our including Such as risks statements are press projected statements These information and

disclaims any statements as webcast obligation by to intent update except on archived for these will plxpharma.com. law. forward-looking The XX available or required be days specifically website PLx our

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

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

Natasha Giordano

I'd to progress. for update with Good joining begin Lisa. morning thank on you, everyone our our call you today. like Thank regulatory an and

and we dose supplemental new Our milligram in providing are the made addition support NDA suppliers changes the data of to strength. regulatory approved XX on the XXX in milligram the the of a FDA to formulation path dependent and submissions

have data milligrams. now information typical the formulation FDA, scalable. both is continue sNDAs of XX the the our to requirements for in discussions strengths the a dose that The data of necessary clearer commercially VAZALORE related demonstrate of and As new the we with manufacturing include understanding XXX VAZALORE

conduct that for BE a announced VAZALORE meeting support we the XXX to we or forward the design plan for filing. the We to FDA morning BE a a with milligrams bioequivalence April. late This and study to confirming currently scheduled study look sNDA

on submission the we're an Once we estimated study can FDA date. aligned the provide with design,

requirements their we look VAZALORE and we've VAZALORE bringing for As announced, previously the our about the be VAZALORE to following to filed forward review XX-milligram remain sNDA, on agreed which submission. path on the will regulatory XXX FDA with confident We market. the

West, committed financing Park PLx, $X help largest that a our will our support investor that million excited Partners to stockholder new We're institutional to have and MSD and commercialization of efforts. regulatory

provide details the will minutes. of in the with financing few you We a

As for in received a milligrams XXX of VAZALORE labeling reminder updated we approval December.

feedback over-the-counter We've research considered from the consumer development of retailers labeling design significantly the invested products, package VAZALORE. to the incorporated the the in be the market FDA. and by For in involving and for FDA is packaging the

this VAZALORE, Our our new the for We an is have unique approved truly to apply time PLx. and to important strength. consider is delighted this labeling a the We're our differentiating dose XXX-milligram achievement as aspirin. plan XX-milligram and to labeling innovative for packaging approved at new

our I'll Rita? to call now quarter CFO, fourth to over discuss turn Rita O’Connor results. the

Rita O’Connor

which is All $XXX,XXX recognized Institute under work of quarter of the XXXX, XXXX, grant, of Natasha. the revenue award performed of completion. to fourth in to is fourth approximately National revenue in quarter Discussing the nearing we results $XX,XXX XXXX. a of compared recognized of of the an fourth you, Thank quarter of revenue attributable Health the

included Research quarter in of expenses the continued expenses were and activities quarter $XXX,XXX both with was related year. of XXXX. and periods flat XXXX of registration The development XXXX testing and the to manufactured in stability in fourth VAZALORE. dissolution the batches fourth development fourth Spending of quarter we continued the roughly approximately manufacturing for last

that Overall of by for as be in starting registration second XXXX the R&D quarter. on are fourth we will the batches, replaced first wrapping BE decrease spending study the on spending quarter from quarter the testing up will the but spending

approximately of compensation. for well of million and compared around $XXX,XXX quarter sales in activities fourth of stock-based $X.X non-cash $X.X a to to for marketing-related General as in XXXX. due and administrative the launch of This prepare quarter the the to million XXXX expense charge as $XXX,XXX is totaled fourth increase VAZALORE of

support. is medical conferences, expense developing professional few expected for activities, levels spend to the G&A sales current planning for merchandising and at at continue pre-launch trade selectively quarters marketing we on remain as we messaging, our and and next presence retail and consumer

net net $X.X lower the in of income stock common price. in fourth of fluctuation was due warrant value of from income XXXX, million fair $X.X the other of primarily our of $X.X liability, million the to income to to down million Other quarter change non-cash the due

previous the lower of income. was Bank As end decrease term The income the of an Valley million in of to million to down expense thus a The by liability with the as loan reminder, $X.X term in offset at decline stock increase other $X.X a combined rates. loan interest to in end causes of decrease quarter due to interest of the the paid the was balance Silicon paydown XX/XX, XXXX. $XXX,XXX quarter compared our price a our principal lower

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

per per addition the share a fourth the $X.XX the in XXXX fourth operating change $X.X $X.XX or compared a million, gain of share related of quarter In the in $X.X also loss of of included increase quarter the to of in liability. million, to to $X.X million, or warrant gain non-cash XXXX

stock or per preferred $XX XXXX. share February in a financing $X.XX for fourth A The to stock completed convertible of Series XXXX charge of preferred dividends million quarter also related $XXX,XXX the included

As XX, XXXX, cash cash we of million. and had $XX of equivalents December

common the partially proceeds was equity Our burn from over a $XXX,XXX overall under fourth $X.X about distribution issuance little of reflects by operating cash from agreement included of quarter of payments, or expenses net million, of our million $XXX,XXX debt which principal $X.X the ATM. our stock net offset

we at convertible Management entered stock into million. mentioned, into per and X,XXX share for Partners of proceeds Asset to with West MSD Park of at price $X stock will preferred Natasha be per and As conversion issued gross shares common purchase purchase a a will $X.XX The Series B share. convertible shares preferred agreement $X,XXX be of

date per of of stop the the stock be for to payable date which FDA dividends accruing XXX The on and compounded Holders PLx's and preferred preferred sNDAs of at will at or in quarterly are XX-milligram. X% VAZALORE annum, option. dividend the approval the initial will the entitled rate -- stock an of cash

Series we the the conversion price. February financing this along is we are very to A stock difference Another with in the financing, being convertible when of on canceled warrants warrants issued closed stockholder This preferred we receive increase XXXX the in main with approval. note, similar while an

quarter of and close expect of XXXX We to end stockholder addition to in satisfaction intend a in the proxy stockholder meeting to customary We date closing second our and notice subject the balance once transaction statement. the set This of transaction to for approval cash to approve certain of a a the a it financing until a quarter the and is the scheduled, XXXX. definitive we should first provide will runway send current cash conditions.

a we prelaunch plan build additional timing capital the prior determine to level submit As we submissions the marketing of spending will financing, once commercial The the of seek we amount and the VAZALORE. progress to raised of of sNDAs. pathway, approval on and inventory additional regulatory

With more activities. that, about she I'll our the details over so Natasha? to turn recent share back can call Natasha,

Natasha Giordano

regulatory critical support will on Rita. In next our Thanks, these meeting to we our months, requirements submissions. focus

impact time result we our will this to stronger will study line, a sNDA BE a believe conducting filings support VAZALORE. Although in

of with such some patient holds VAZALORE, large such For care in professionals may let highlights a it population. believe me health we be those for unfamiliar why who promise briefly share

the is vascular a VAZALORE is category innovation an a aspirin aspirin more treatment new, capsule, decades. disease. important in liquid-filled has of therapy in VAZALORE better reliable the first that anything and new had not for

vascular Our addressable market stroke of includes vascular have who had patients, procedure. heart is comprised a a or which attack, people

than a the market a aspirin recommend doctors These vascular represent includes United have billion having two groups together potential people event and and who XX initial $XX patient an diabetics, market. retail million higher risk This also whose therapy. in States more of

raise awareness to scientific is our community to communicate the launch VAZALORE's results. and Central strategy amongst medical

clinical in and the continue engage neurology in and to that cardiology, and understand our vascular leaders We gastroenterology invest their of disease. of they ensure the unique needs therapy benefits innovative aspirin to treatment understand thought with we

the original health. the An formulation strategy. and of of essential Stroke disease science International aspirin complex a at a and of entitled The meeting of XXXX is of an cerebrovascular states Conference. of component poster fed execution aspirin February, fasted commercialization pharmaceutical to our In bioavailability presented the in brain publication was dedicated and treatment premier lipid novel

aspirin coadministered on The results without fact The bioavailability. taken with stomach Journal and that of may can The aspirin with food clinically in on Thrombolysis. was published empty VAZALORE is simultaneously deliver the study reliably, an of is impact it Thrombosis be whether that irrespective or food significant. VAZALORE significant established

the We're for excited ACC. was extremely in other was at and genuine been better a feedback there have category. positive that aspirin presentation enthusiasm The product two for accepted abstracts

patient profile with is crossover aspirin enteric of compared first The level improved randomized coated formulation liquid analysis pharmacologic studies. novel of a a aspirin pooled entitled two

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

whether has the we are on be conference Although waiting been canceled, for or held confirmation these not meetings will online. ACC

panel Forum Cardiovascular trials. neurologic Review In of cardiovascular D.C., meeting, and The participated experts discussions January, is XXXX in Intensive focuses Trialist Neurology management Stroke we Update and Washington disorders. In a attended the for Clinical diagnosis which clinical December, unique leading meeting global developments the at in in in we on interactive which

of of a that our component forms these believe with disease experts vascular preparation field commercial at is key for presence in launch. We our the prestigious

in these scientific and our vascular with engage an important ultimately component we VAZALORE robust understanding their disease. specialists, establish data as is of to evident to it is As critical treatment of the product that

these developing Our and to will strategy. purchasing pre-commercialization trade decision. health are our the ultimately plans commercial and at marketing retailers make constituents key productive include to Together consumers aimed retail discussions and pre-launch with care efforts the three consumers continue who professionals, activities

the with ahead With I'll go instructions. that, the Operator, call for questions. open please

Operator

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

is line now Your open.

Elliot Wilbur

morning. Good thanks. Hey,

Just BE on of additional questions a couple follow-up the study.

So terms I January you XXX old in the clarity you formulation. in back to new bridging the of thought essentially bridging of the sort and early the XX-milligram and update XXX eventually the then gave the needed

in kind evolved that you So somewhat since kind or what I'm this the path? changed curious first, agency's down thinking of led maybe has of then new has

strengths the exactly BE is I'm had also two new other what using XXX would the has happen study going include the reference Then to itself -- XX back XXX you new trying versus to Or it or versus is BE? the the then sort of in on Is study? old basically early And what XXX? is that you expected occur the the January? some BE in it are versus in what forward bridge XXX protocol the to just two the the an it simply drug? competitors

Natasha Giordano

Thanks, Okay. Elliot.

and back down as our the regularly continued pretty modeling we with path. data in approach interactions January, we So as that could been have announced we and FDA discussing we have well continue

very a a do have their studies, was crossover bioequivalent simple they to we that advice However, recommended us. bioequivalent study,

we plan to so And those discussions. continue

end scheduled to We in the design. on align April have study really a meeting of bioequivalency the

to going but align in on feel comparators do with to And that FDA FDA. our until approach also confident their recommend what the are So I be But we is will won't probably we strengthen this the the very confident approach a bioequivalency because typically alignment. submissions, is comment study.

whether one, a bioequivalent or and, simply doing to on again, answer on to study to simple our bridge dose the doses, question your back approved we XXX-milligram plan do originally be this both we'll for the study, to not XXX-milligram So formulation.

components? milligrams. with the all aligned and which them that Did for then, we've require XXX already XX-milligram manufacturing-related answer And I type they back information, on dose, with supplying what bridge is of the FDA the would your the to information cross-reference

Elliot Wilbur

just versus Well, fair? Okay. prior? -- Is study basically formulation I is mean, the the like the I that BE comparing it sounds new

Natasha Giordano

what a April. comparators like shortly, and FDA said, we them to going the is. align once come to proposal let since we we that you on be. that end to And Well, with that meeting with have the think them we're the what Elliot, at we're And back study I the and should of design submitted on be you should know

Elliot Wilbur

then, the guess, comment should be the obviously, relatively based this low of on now on maybe maybe a is I but obviously, relatively what are just study, of expenditures terms complete cost, quick kind Okay. could And to thinking what it these finish know? necessary I from start mean, and, around to in your time line you incremental but Rita

Natasha Giordano

Yes.

probably like right, the a BE it study, most relatively study, standard conducted. simple of terms So, in is are studies you're

we'll insight we've like understand FDA this simple study. once that we standard any with they cost? study other take agree, better be then the it don't I design that you this the think if bioequivalence If agrees have should design. proposed, Why

Rita O’Connor

Yes.

the yes, should be terms studies. compared to cost, other In relatively it inexpensive of

built kind cash into of burn And the that so forecast. we've

second going good a testing manufacturing spending the study. on to the less quarter is will replaced starting that of news So cost be BE with we're the be in

similar going on to levels out So relatively to we've spending come it's been R&D. of kind that

Elliot Wilbur

Okay. Those Thank were only you. questions.

Rita O’Connor

Thanks, Elliot.

Operator

[Operator Esther Janney. comes Our with Instructions] Hong Thank question you. next from

Your line is open. now

Esther Hong

morning. good Hi,

stability been taking Has can updates So Thanks. testing completed? provide was you on already any this that the place?

Rita O’Connor

Rita. it's Esther, Sure,

continue going XX decided actually we now. good normal and testing more which one process that stability to which much protocol we're months, three formulation to of nine stable the is, than again completed ultimately reasons the then months. we months, is this are the and go months And so with We've formulation. it's six doing in stability yes, the for old the So news was

able submission what completed we've be BE to the for completed. is filing. for ready So need we the we'll the And study be once

Esther Hong

Okay, there to sNDA are gating submission? prior great. And factors any other

Natasha Giordano

and completing on we've Just the then course CMC which package of the portion been completing the BE data working of study all the forms along. that supplement

anticipate strong make submission the pieces a we the have all we'll to this for that So FDA.

Esther Hong

you. Thank

Natasha Giordano

Esther. Thank you,

Operator

not I'm for questions to any at time. now like back you. Natasha Giordano the closing Thank turn to remarks. would further this call I showing over

Natasha Giordano

on potential and continue standard to of patients market management at disrupt better PLx risk in our and Thank for bring alternative regulatory vascular health aspirin your disease. commercial great VAZALORE the you and a a and the millions new a The to and mission you. and care have of We're Thank to aspirin day. new has excited to for time advance to efforts. become the to care. transform team is professionals again

Operator

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

You disconnect. may now

PLx Pharma Winddown (PLXPQ) 13 Mar 202019 Q4 Earnings call transcript