PLXP - Earnings call transcript Q3 2018 | PLx Pharma Winddown Corp.

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Operator

Good morning, ladies and gentlemen. And welcome to the PLx Pharma Q3 2018 Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] As a reminder, this conference call is being recorded. to conference like host, to now Ms. would turn over the your I Relations PLx Wilson, for Lisa Investor Pharma.

begin may You your conference.

Lisa Wilson

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

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

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

our archived one webcast information in dial-in for press website will on plxpharma.com. available be find The release. year will the You today's

PLx this and be of archived may those discussed. have the related was the announcements then, X, topics who recorded held For call to to XXXX. or listening Since November the made benefit may replay on webcast,

Natasha Giordano. most the recent over and CEO, the press will turn SEC reference call that, to With So I PLx's releases please company's filings.

Natasha Giordano

Lisa. announced Last you for outsourced FDA you, that the Vazalore. cerebrovascular during for excited key of technology commercial aligned cardiovascular alternative. our company advantages pleased the of is unique Good in at joining us. scale discovered identifying next progress the formulation. Thank thank is patients testing name the an believe We new generation having inconsistencies future the am name Since an on transfer aspirin some And in new approved we our event. Last were significant you its we we've time, with and reveal quarter closely to more Vazalore. ingredient clinical Today, we risk process for morning, that singularly I a that share everyone. made with some toward to spring focused and to launch been novel manufacturing, development or

in US-based a and identified ingredient dissolution key we've in foremost, supply and The First of results the stability of PLx achieved formulation. alternate Vazalore. team new has testing a successful consistent initial

confirmed. been We ingredient has new have in our current the been three key The including have internal lab. their good manufacturing confirmed confirmed, supplier labs and been which of practices

in and mid QX; batches FDA Vazalore As Targeting XXXX. steps, QX XXXX launching preparation next Type development sNDA far the the in of end the meeting the of forward the manufacturing in path C pre-submission filing in QX; the of briefing scale and as with the packet of meeting batches include, registration completing the will FDA submission the in XXXX.

to our critical to we care bring focus opportunity as turn formulation I safety and market disease. the call to prevention for O'Connor. the our With to the standard product new will optimal market. the to Vazalore secondary in excited for that Rita? ultimately need cardiovascular the our unmet address over approvals patient program continue obtain of and advance position CFO, We're of in Rita consistency, on the We Vazalore and as the

Rita O'Connor

XXXX. support in in $X development were of and Thank third Research XXXX from Natasha. periods revenue periods of to formulation compared of novel manufacturing chemo reflects compared both to of work performed of is quarter for revenue the continued an of for This Development aspirin year attributable of recognize colorectal $XX,XXX million federal the to and the the In for of for third and and in $XXX,XXX quarter XXXX, period. quarter National we in the award expenses million XXXX Health XXXX PLx's cancer. XXXX. The grant Revenue of third grant Institutes is both expense you. received prevention activities the Vazalore. prior product in $X.X

cash expense plan of due stock the The an in includes Interest decrease totaled this development FDA compared of Non-cash related the spending causes in $XXX,XXX non-cash XXXX. net loan Administrative reflects An be of of quarter change the batches, increase amortization expense net higher of the formulation and due manufacturing to expense manufacturing increase includes for approximately of to Future that's Whereas price briefing This in compensation the interest to price interest through included expense our Silicon an the XXXX. expense expense change versus rest of of we the stock Bank, decrease Type third liability XXXX. primarily period. which on income. warrant stock. of XXXX largely of work the the the the the the area term Valley of of other in net be quarter package end be $X fair $XXX,XXX The third in and your lower merger new After the to of million commercial and $XXX,XXX will common discount was company's will of with fee the in liability the company's of months the in prior $XXX,XXX to quarter quarter XXXX. the C to year period. payoff XXXX General is meeting. in Vazalore. Other related based debt stock XXXX loan. loan $XXX,XXX attributable increase compensation income compensation used causes the price entered of decrease batches in only scale $X.X and that's the the of third expense to incoming million the $X.X to for FDA in to quarter million into This quarter a registration third expense August finance of include non-recurrence for was the payments. interest included XXXX in two in the of of third of the for development XXXX other prior meeting, on fluctuation a of at quarter $XXX,XXX for third submission period liability compared value and will the end thus accrued and the in same the primarily the scale sNDA totaled XXXX the a

payments loss higher begin We loan as well also versus the paying quarter. due payments paying interest but principal term XXXX Interest higher currently as $XXX,XXX rates are income on equaling February per was $XX.X XXXX, in million only and Net per our balance the interest quarter share we approximately XXXX. starting of third in cash million. XXXX the in higher for third cash XXXX share quarter in of $X.X cash burn equivalents or the XXXX. or was compared to $X.XX million and million of the net cash quarter a September per $X.X for $X.XX for was $X.X with loss We to

With own in We cost on our I'll discuss Natasha development that the have the successfully through our doing formulation call spends. work to quarter cash preserved launch. by the leading new carefully up the the out and back our third Houston plans during controls planning some to marketing turn of pre-launch Natasha? to lab

Natasha Giordano

Rita. you. Thank

capsule our -approved experienced need that become management the antiplatelet next-generation to action, assembled it. the deeply critical set of Now reliable and first-ever GI let's novel predictable as unmet address aspirin commercial care filled the of team believe a standard has liquid We disease. has the it FDA Vazalore's turn improved to strategy gastrointestinal been product. mechanism apart cardiovascular prevention potential and the Vazalore execute and and safety aspirin the efficacy a of as in market to secondary new to or

high Our these prevention prescribe indicate extremely by findings. patients, to we're and market encouraged a their for recommend Vazalore research shows secondary that intent or physicians

highly I'll atherosclerosis target not like we team fall to disease to XX which a patients I'd history you of which call is with familiar without disease secondary we're aspirin the the into about a of unstable provide with also an disease the Association disease supportive the positively ASCVD, of in implanted, product. clinical about results disrupt market are impact for Vazalore with cardiovascular have to of greater cardiovascular We qualities, trials on the about top-line with health. those reported For or confirm why like history million aspirin XX,XXX Vazalore with potential may commercial prevention refer view the aspirin both history the clearly these States. these MI, our live According has primary diabetics patient's Heart management artery TIA, so risk than trials peripheral who be need unmet United cabbage patients including therapy four aggregate events some a to finally established in Recently the coronary why market, product, for artery people at as positive stable new patients high more of aspirin a And high-risk on stroke or and plus the the like is that and highly believe angina, unique as disease, background indicative a includes And market is and Vazalore's and of cerebrovascular stents or excited cardiovascular this these as Vazalore disease. of ASCVD. on generation market. and had established secondary disease prevention. is quality treatment as the strategy American and patients and results cardiovascular

worldwide. GI considered to the often shown aspirin need and aspirin complaints opportunity to concerns. our but their today fail aspirin. a our duodenum aspirin which of into treatment potentially the the surface advantage Vazalore these antiplatelet stomach common $XX used it is it many for address the it patients into Initially a efficacy to enteric-coated disintegrates is its these injury. developed patented safety. passes drugs of people and improved have tablet contrast unreliable XX% million delivery extensively the happens pricing. GI market upset, gastric of XX offers unique was and stomach Of about GI tract. because not have protection By of into variable foundational system Vazalore PLxGuard as not release represents have for most areas protect which enteric-coated potential can $XX those take Once GI This market has back which as million tract, of daily aspirin only market the process four aspirin ulceration. studies free at unidirectional ASCVD; retail therapy, of action does does the enteric-coated Because targeted that such more cause Yet makes the and people releasing in actually represents reflexes inducing selectively GI Aspirin what than patients billion aspirin The mechanism steps. takes enters

pH in the First, low matrix releasing the content. capsule lipid dissolves

agents and absorption. lipid rising with for aspirin the digestive now pH Second, matrix free emulsify

greater and for distal back lipid Third, tolerability. direct the ph distinct aspirin. protecting into duodenum. our life. contact the when efficacy, with reason aspirin lengthy the namely This fourth, contents thus And the clear from content and reflux is leaked reassembles environment, And advantages in is the patent safety the and stomach strong process absorbed matrix absorption, offers the

We our of depicts video able have be these that will professionals simulated access recently action that as GI mechanism capsule developed a to new on travels a Vazalore through our advantages website healthcare tract.

aspirin is to of a to the understand complete of Both thromboxane that at antiquated suppresses an is consider the complete thromboxane response. response the inhibition Vazalore A what way surges benefits product level practitioners XX%. of look market far of at therapy FDA is and inhibition aspirin means best Another called Vazalore clinical aspirin apart marker will of a response with we Vazalore complete to aspirin more current sets what a believe What disruption to in be lead enteric- that and achieve aspirin. the care coated is the to likely effectiveness. compared the standard

patients. and Our interventional believe to has lower very data be of they Vazalore find their We consider compelling cardiologists data acute will when that for caring specialists than options aspirin. ulceration risk XX% suggests that this regular other gastric for

of we with further from or feedback preparedness, about has and community leading fact, and cardiovascular exciting endocrinologist XX% encouraging the In professionals intent and the esteemed world-renowned specialists neurologists board around scientific value patients. XX,XXX Advisory To is to guide change Interventional articulate our as was medical commercial world Conference, leading that one care proposition gastroenterology. is potential School standard engage Mehran Most of They significant the medicine. efforts Vazalore's in Officer potential recently, for the with TCR to to look cardiology nearly in our collaborating meetings forward. to over cardiologists, Sinai unmet course market need. indicating Dr. with the Last Cardiologist across with it opportunity recommend our market Research advocacy clinical There most to of medicine. Cardiovascular especially key thought Director Roxana in Dr. we Vazalore's efforts for ASCVD. which leaders including their treatment TCT a our are specialties take believe Interventional formulation Sinai our interventional advisory awareness represent and steps pleased joined the and we unmet largest to educational continued We're our continuing to in of recently world. These high and our a European as Vazalore thought we we the the raise Euro specialists engaging we connect specializing recognized of attended thrombosis and awareness. Mehran and critical address is Cardiovascular Trial Chief Deliargyris, May, Vazalore Trials perfect important high-risk prescribe Clinical see and opportunity the leaders also medicine Medical educate Medicine, Vazalore professor the in were path expert and to a is and and continues of to key as bring Chief and interventional a and Cardiology and the medical Dr. an aspirin to Mount medical in Officer Research of Dr. important need to Conference, build the announce at thought the Clinical attendance Mount as around Center Society engage and of leaders. attended community, a better internationally cardiovascular Conference Scientific Scientific this been of has Board. at Their Foundation. the broad Deliargyris of

patients we emphasize life we believe has been discussions word are into how promise management We can patients us A the as retail on drugstores one to category PLx about can PLx overall. the Vazalore trade of and here team that and feedback every top of because and based the can with potential how continuing merchandisers how the has their this including impact Vazalore assembled at aspirin we in the PLx. Each joined the chain new Vazalore and and believe category. together help mass breathe that has change it

OTC that Neurontin switches Motrin. quite have differentiate executive Mucinex, and to bringing of and us products successfully. products Zantac, their Rx up will Directors is executives launched experienced care of unique capabilities Each of To Board for like Lamisil and and just and Lipitor, OTC health and like Rogaine, few, patients a Our and team made that distinct deeply Rx name providers. Lyrica Vazalore Claritin, Zyrtec both

We Let me believe toward the in fill saying all to consumer and in retail the of actively are To outstanding Vazalore Manufacturing, ultimate conclude gap in interim we mid significant engaged the XXXX. secondary take leader thought and fronts. product steps prevention distribution opportunity that by launch and our on market. approval the messaging. a engagement,

ahead lives agents received at-risk PLxGuard of is the take call team and experts established from response using of we've improving to credentialed I'd in questions. committed the pride patients. instructions. delivery enthusiastic field excited targeted to our We commercialization. With highly and Vazalore many we and performance improving Our the and is thought about the the proprietary as passionate leaders key go management move therapeutic from the Operator, that for towards inspiration like open with please platform

Operator

Ken Trbovich. the line from comes question first Your Instructions] of [Operator

Your line is open.

Ken Trbovich

for it but didn't forward fast I gave unfortunately Thanks appreciate question. was Natasha, I so catch the all. pass it you the taking

quarter said Type be meeting What the or a briefing follows the that? pre-submission second first You C briefing submitted and would package document quarter.

Natasha Giordano

Sure.

to meeting and then launching XXXX, the the in of the the targeting Vazalore FDA registration filing --we're complete in targeting sNDA or mid the the submission XXXX. and held to be So Type-C with are batches in QX we end then QX;

Ken Trbovich

Got would NDA? with it. normally manufacturing And looking is remind us a again we're we at of this sort review that supplement, a not standard so month six ten see of

Natasha Giordano

the briefing have assumption our of but we --our will the this --there's same show the be clinical studies this we is manufacturing with supplement. Correct. that they when need. the in be a meeting, understand no that supplement FDA had that manufacturing to package both submit Ken, course FDA way. --we FDA in to we We've This communications regard, to that our need CMC done. doses is a then things a not This will we're is the purely for and

Ken Trbovich

a because the Right dose, already XXX so milligrams side. reason manufacturing it's it has lower the just no at than approved other on anything look to from dose NDA the

Natasha Giordano

nicely - right, That's

Ken Trbovich

certainly wasn't supply but a new So, slight know &D reflecting question commercial correctly. given of be implications assume talking fact sometimes there can submission and those confusing it we to costs sure I make if commercial a batches sort convince single-digit look after details we're and that not. for I millions well, year? trying you that would was those it's for sure the is thinking R&D one I to obviously digits batches be me should last How the I key double the ingredient. to have year for recall which know commercial yes that had of and you for uptick source going you just to batches the guys you, about positive for or that know whether Rita, back sort next more I'm in the the have so and to because start of signs do like of cumulative initial batches then those do identified you're

Rita O'Connor

the they'll think don't will million manufacturing, the of I been overall rest that into as if in do going XXXX put which you No. burning, you had $X get for start we'll process the to the for go so burn will the you we into so scale the first about probably it scale And development are packet. we're and thought registration. double then but then XXXX batches larger eloquently digits look smaller put that as burn, in cash briefing

So, the yes, as starting see $X on increasing to I principal million start also in cash burn you like the going our more loans mentioned, operations, but can February. our we're paying back for then term payments

So will that $X to up million. bring closer that

Ken Trbovich

a And the filing no? last fee at for the is submission I then perspective of this apologize a being question promise. from or due type application of there this I and looking From perspective the

Natasha Giordano

No.

Rita O'Connor

No.

Ken Trbovich

Okay.

Natasha Giordano

as from FDA. confirmed been well That's the

Operator

of Your comes Wilbur. next Elliott question from the line

Your line is open.

Elliott Wilbur

morning. good Thanks,

First Obviously, inactive is active they required of is something And that pre-approval actual couple --as directed this question currently I a ingredient? they that's require entity already part you or supplier, supply by a to is because of guess the itself part source. sort some that is an alternate inspection as approved FDA not it FDA GMP respect of supply known commercially sort fact the or are to client simply name submission to going product? is a the the since questions of your this along the mentioned ingredient around lines the with but that

Natasha Giordano

Okay.

that be so remind --we there'll good think an So inspection. FDA don't me,

has that site know had company inspected. their this we FDA However,

benefit. all. CXC with So successfully also compliant is audit are done there we an no GMP They added have an at We've which findings no quite concerns there.

supplier. the encouraged So was and first what-I we're this confident very new it, with question what answered And okay.

Elliott Wilbur

it's of secret trying commercial they obviously No, or to if yours it just well, if it --it's the but the if a a as not I containing sense was one. product? approved another Yes get secret-- clearly is, if part produce a ingredient

Natasha Giordano

Yes.

Elliott Wilbur

stability me remind I data the duration of with sort of XX milligram, resubmission And to what of again Okay. the guess is? of respect required

Natasha Giordano

months term, Three three accelerated. on months

Elliott Wilbur

submission to in not then bit so XX with. I there the quite be maybe bit And I last research is ultimately may you company the that more and the of just just going understand of that wondering than leaders been whether months the last they influencing curious has out spoke efficacy efficacy aspirin of or your just what Do market am now about some interactions last question decade. sort might Vazalore? and whether and a that new talk an medical opinion Okay, attended. you actually be a XX probably your message worry you about you prove recent really how in part? practitioners commercialization? observations a there's as not know message quite or the think of these feedback on providing to FDA had any to And interactions ultimately useful or or events

Natasha Giordano

larger Yes. Deliargyris; interactions We're drew the he the yet had. mentioned that to to had conversations more to his me. was him companies very here with came He but go here I what other Dr. about established, and product excited this we've opportunities certainly company.

patients the cardiovascular the With the the that pyramid, that these the thought how Elliott, terms are and should top of secondary prevention medicine be people in narrative these treated. key drive really of leaders

Steg others in And critical But the think a really and address can strategy that was that need unmet and is commercialization people this primary found it's several reported to where that that's in trials Bhatt, on key risk in aspirin like for be feel discussions in Dr. encouraging benefit there weeks, with and both these prevention, patient. our significant Deepak secondary ratio. that and You're prevention. our although Vazalore released of prevention very right thought the all And secondary clinical targeted weighing and in the very about Gabriel leaders market. I were trials towards those primary we last specific

that XX of this efficacy. million that need people Here, patient to we a have group in have country

or the their order second that's which in aspirin be in really also The GI resonates their And have event because first message take benefit fatal. of resonates. to day. that efficacy the to it don't every a where message you of get So they value have could general

And a so breathe that will been category many absolutely years. that our and safety, have that's we in with life new quite we for efficacy improved data both feel something into stale

and and our very want feed confidence consumer first, that commercialization it encouraged does specialists they strategy to our into to we're that So supplement the data in with messaging the sure we understand out well. make that as some new and reach

we're we're So excited to about months bring away. this about XX where to market

So it's coming soon.

Operator

I am showing now back time. this Giordano. to turn Ms. no I would at Natasha the conference to further questions like

Natasha Giordano

very Thank you much.

of So in we billion. representing ASCVD see patient class opportunity for confident has ASCVD. market, be and we a within on best a addressable market market aspirin as the that potential this Vazalore We're therapy potential reenergize the tremendous to retail to population, focus the $XX

our great about standard generation next We current in that and need potential are joining Vazalore, launching treating excited the the you morning. has Vazalore We to in addressing novel a Thank ASCVD. this have for And us of day. XXXX, aspirin critical mid believe care. transform again unmet a

Operator

participation. Thank this a Ladies conference. have day. gentlemen, concludes and wonderful for today's you your And

You all disconnect. may

PLx Pharma Winddown (PLXPQ) 9 Nov 182018 Q3 Earnings call transcript