PLXP - Earnings call transcript Q2 2020 | PLx Pharma Winddown Corp.

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the PLx Pharma Q2 2020 Earnings 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] I would now like to introduce your host for today's conference call Ms. Lisa Wilson, Investor Relations at PLx Pharma.

begin. may You

Lisa Wilson

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

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

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

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

Natasha Giordano

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

and to topline Type with for bring work the and call, submission aspirin to end and all to together new our meeting XXX-milligram the in will report to option. VAZALORE discuss live further our how the pleased with several patients and to At significant VAZALORE product we strength of transform now finalizing dose timing and the excited the disease CMC that formulation. PLx, we year. VAZALORE, of the We're submissions Rita? quarter of commercialization of with strong share also on mid-November, ahead We times. strengths XX-milligram CFO, about unique including the vascular release made aspirin timeline market. to received to of now sNDA second As the believe continue our requirements last BE importantly, progress learn supplemental agency. results additional the evolve, results. to alternative our the a the of a professionals is study, over the the this now the Since their to Rita potential category minutes previously aspirin on promise and data the care in VAZALORE health and advance shifted filing, to committed treatment our call turn We're for study giving world on We these our report. I'm to the bioequivalence we've we've design of the process FDA to continues I'll basis O'Connor delighted final for BE the form I'm a focus C filings to regulatory confirming to had fronts change market. trying our that to bioequivalence study immediate demonstrating commitment the track the the with the that the of on BE study or supporting dose novel XXX incorporating VAZALORE

Rita O'Connor

Revenue from and pre-validation the totaled We the Thank study June the the second of milligram grant quarter ended $X.X and end primarily you, of clinical-related periods $XXX,XXX under a spending which XXXX year of National quarter stability ended XX, $X.X XXXX. Institute development of in manufacturing for recognized the work in XX, for XXXX to federal Health an came XXXX. performed months attributable quarter compared XX, the both quarter includes for to prior continued June XXX VAZALORE on activities. Research revenues expenses three $XX,XXX BE revenues June for expenses Natasha. in ended million and versus The million XXXX for is the to period.

consisted XXXX the of to reimbursable with quarter expenses. the second registration expenses of of manufacture related mainly The grant batches combined

XX, year. the also to year reflects loan. to the activities and million compared is prior balance financing to the After messages the our spending as the XXXX with additional at the is lower activities completed on of significantly is totaled of reduced $X.X Pre-launch merchandising sNDA interest lower to and Interest consumer and of principal of Validation study sNDA The rates the begin R&D the VAZALORE support. retail and due for remainder developing and term conferences expected compensation report three G&A and will remain capital our and VAZALORE. spending travel as is the $X.X June ended submission and launch prepare lower into is remainder due will declined decrease trade to planning for additional VAZALORE. expense include the commercial year. combined restrictions Interest income due related rates BE year, higher current the and offset sNDAs declined is decrease for professional incorporated production of versus increase the expected For by prelaunch are administrative General balance obtained, period. the submission. cash we expected expense and expenses spending interest for prior lower levels to the and to on in expenses in on million submitted once COVID primarily lower months spending obtained.

million declined XXXX. to related This balance of off Our of the $X.X June. paid change remaining as is in is expense end first term loan value to fair of The expected the quarter be the in to $X.X loan of quarter period. the to year from liability decrease of of prior of company's million common largely XXXX the second The the fluctuation the in warrant price attributable million the is in the stock. $X.X

per B thus reminder, XXXX an the After May XX, $X and approval or we versus preferred XXXX loss or will diluted end approval B stock on stop accruing of preferred with for and second to per attributable the warrant stockholders dividend loss price causes for previous entitled date XXXX. completed Series dividends dose $X.XX Net $X.XX or dividends. or operating As lower West increase share $X.X of a to to A of million X% a of of FDA share Park The million compared share to receiving the $X.XX a stockholder per Series B was and in $XXX,XXX the the $XXXXXX due an expenses stock the due quarter was the to $XXX,XXX quarter the quarter an the stockholders in to both Partners. to the on in for the liability quarter decrease or related $X.X of share increased increase $X.XX the in the $X.X second at net of of addition common are to loss million to per $X.XX VAZALORE. million net lower of convertible the $X second end the in Series the quarter million of expense. per of of financing preferred expense the basic in Preferred compared increase of and change liability year MSD XXXX the share. stock stock which strengths of

cash June of proceeds the B May. million reflecting XXXX and cash in net from were the equivalents $XX.X million the XX financing As of Series $X.X of addition

around be We prior spending build The the cash upon expect remainder approval obtain submission marketing plans sNDAs for pre-launch the VAZALORE. the of quarterly commercial to company year. the fund to financing and $X.X million inventory burn of additional to of to

supply operational VAZALORE. significant that, impact turn to progress. Thermo manufacturing on Scientific, to it to our fortunate U.S.-based our currently to not COVID the the as that have we With Natasha outbreak, partner we Fisher I'll experienced elaborate is Regarding back are chain. call fully and relates any is our

Natasha Giordano

Rita. FDA required BE you, the had the as immediately CRO. study engaged study the Once study. commence successfully to we subjects We and on aligned we IRB a with qualified able approval design Thank for the healthy obtained we already were quickly recruited

eager included innovative the CMC analysis the six timeline. the for be conduct the period study XXX-milligram We're immediate BE Once to four preparing submission, while data market to about bioequivalent demonstrate the next FDA of of with the were keep to to release to announced to The year-end the is of prepare parallel. able VAZALORE of step previously in timing report submissions without bring required to these related in recruit and topline shift change in submitted results XX-milligram to be pleased Fortunately, COVID. all any this therapy able and the to ahead to mid-November supporting VAZALORE the is The submissions formulation. the and the months. typical review formulation types the to submission delays timeline is new clinical further patients study aspirin we to

consumers world. We're the appropriate to third adequate assuming launch and capital now Central consumers. XXXX professionals are including dosages COVID-related our evolving is the delays. strategy activities and healthcare We funding approval, with healthcare on and executing commercial virtual communication our platforms focused commercialization professionals, VAZALORE targeting no for of this both quarter FDA of retailers in the

of the conferences unique to attributes. field are VAZALORE's prestigious We presence in to with and our highlight the maintaining engage experts

raise closing, PLx dialogue can for the innovative and partner that, priorities Advisory vascular about aspirin are and instructions. to to patients from third on the the please Additionally, new potential target of complete activities our sNDA go and mid-November I'll strategically developing we've our an ahead consumer therapy. open support. delivery With submit quarter year. awareness millions our Furthermore, of next messaging mechanism call remaining for at retail with questions. and planning and VAZALORE how community merchandising highest In to Scientific the of pre-launch with the Operator, who filings active our steps, trade its regulatory for in launching VAZALORE's continue the the a including we're Board the with marketing partners, to to maintained help benefit medical

Operator

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

Elliot Wilbur

pulled nice see timelines morning. in back, other My common. question first be Good to being push duly Thanks. the noted. direction will It's than meaning forward rather moving so

the to a ones there of at FDA. control But company's hear what gating submitted. this you of prior control to anything? checked we it Just mid-November submission With maybe need, a the any matter are of have other here. package of that to you items It's were submission in sounds want like point. data the the factors the everything And couple sNDA, somewhat if see off I everything will from if additional expected basically to or see respect entirely before then quick to and or essentially outside assembling submitting be outstanding advance the need gets company's with filing in in you respect to that the just

Natasha Giordano

well. Okay. as something a achieve. call Thanks, Elliot. to and We're always terrific is we pretty timeline that always excited this try about Shifting

we're you. and call can So happy today's share what about really we with

it in factors. right, additional terms I have think gating of you

to the results VAZALORE that very in shows we study results, bioequivalence those BE line confident comes feel to release the immediate As aspirin. top

be the process writing be in these that in and and we required submissions. we're both now the all elements to the process documentation preparing filings, submitted of continue to have for so the administratively And

so been to and along be to on all feel mid-November. we've submit working going we confident So we're pretty these that filings able by that

you may we've In what that see, terms let those confirm will filings. think of submitted know certainly and you I

to as I years the the such to we why study achieve. far like bioequivalence the ago is critical we'll think for for understand need milestone was to that's we thing approval it. data, But everyone think As to of and did VAZALORE, demonstrate a the us that important for about bioequivalence release most immediate

Elliot Wilbur

minutes, the results results study, of to then and any BE the of originally Okay. the changes guess labeling? conversations with the of based And the receipt And agency the I in also the FDA any change approved actual on BE proposed study?

Natasha Giordano

in OTC FDA are suggest itself. time the changes the with the from packaging the packaging a that in Yes spaces FDA the we And we've invested and from sector question. is the discussions you the And receive labeling. there the No would we that's did approval market lot Remember, the would know, labeling. there retail a great be – labeling incorporated that research, of feedback labeling. for no

quite submit and So It's supplement and we're as CMC pretty excited of we any but of about our anticipate we'll the changes packaging. don't there. part that course differentiated labeling our

Elliot Wilbur

just then queue. back the last question And hop Okay. in before I one

the quantity? require sign approval. sure It's, share aspects cost expect And order think time like, your of production of manufacturing obviously, I follow-up once of the How subject FDA what just So unique the small, about dependent obviously in are of to sNDA that as they're the necessary investment you commercial in and process the is but generate future CMO that in type pros just launch side a maybe batches. on then is you be do might validation advance required to the obviously, thoughts off not financing? and around preliminary submitted, facility active mean to matter capital to any but that. command upon but think incremental like the manufacturing of we of relatively Patheon,

at facility need get requirements final related You need additional or be to you Thanks. checked that are maybe before to any inactive a off approval? pre-approval the inspection the key might other supplier there can of FDA-related the

Natasha Giordano

Okay.

So a in that. lot

Patheon. are we So with working

daily really As partner to speak are work almost to and there. with fabulous pros. you go said, They're out them they and

been we've and of in our them trade. and the true they've been with a to working terms forecasting us production we're with and working also retail So partner

team So job it selling in. great a is our doing of

try a up out So purchase to the and going in back have commitments. couple we next firm we're that really of date the months to now

so think to be is And this going big. we so

to think in how in this that could months considering going uptake really of I'm up store is team a the to take much every a product quite gear country. manufacturing So of preparing for and get couple really the and money we lot

to sNDAs I for in the preliminary have with we'll numbers it next really for get in the trade, retail feel have They will of we the don't and of the we capsules, as I but months. try had on make can do you packaging at-risk approved terms We Once little inventory said. those will couple needs what FDA So but sure and you cost, the has prepare submit as do better and a meetings hold the and possible approved package. as have accordingly off manufacture as XXX. the

hold to same we'll that on And but make to approval. we'll possible. be to of much sure will said, we're off How risk do at-risk that assuming much as and how -- So as obtain prior you as going XX, much the well. we're do it we the with do try to want depend financing as we

we lot on a months, over submission. that out of will sNDA next of shake the So while focus itself couple the

about FDA's a typically the You inspections. asked require Yes pre-approval inspection. they

so at a great lot been inspected issues is any Patheon said you foresee a this. As there. their lot of clients, They've with don't we

Patheon as API, would doing as as all it based see, as we seems requirement. that ones are well that FDA audits is know raw anticipate inspected, miss doing VAZALORE news but Ohio audit as be but of inspections, And put And your good is sources, don't and excipients, of their to we're as manufacturing plant. -- on the you our well not need understanding themselves. are we don't excipients our like of planned. anything we the really inspections inspections material I Cincinnati, as as but in that own my continuing we'll now our So a the and foreign a the they questions? required hold has U.S. in We're expecting our Do

Elliot Wilbur

No.

Natasha Giordano

Okay.

Operator

Thank you.

with from Your JMP Securities. next comes Butler Jason question

Jason Butler

all the the for progress. thanks add my taking let me congrats questions. on And Hi,

you steps then plans. until us the to once approval? to if your to wondering, any anything what agreements are wait product I getting to the to And forward, pharmacy need pre-commercialization some get degree, of getting terms inventory else color get you need of go out you before you could approval need that on more are can't build on thinking Just Thanks. approval, post-approval commercial the -- shelf? on that in give the that -- happen for the terms in after it steps that know the what but shelves? So

Natasha Giordano

Jason. like we're these filing things are submissions made. coming All I developing Yes, plans. are that about milestones and our commercialization to before, are pretty we've the mentioned Good excited important morning -- approval progress and then together parallel, in most

partners, Our commercial and the strategy is the really areas; based the professionals, on retail health care consumer. three

those different important of three And best to engage this messaging sectors, platforms of to how truly do on to do communicate very makes makes we platforms we're plans virtual stomach those And COVID best continue three so showcase utilize delivery we're and that and going areas. kind evolving on at VAZALORE of it because injury us. the how also develop uniqueness world, stakeholders and will can effective what all really those for differentiate mechanism and of risk. reach to but center through and in communicate looking Those less its we and we with that that different so for which is more VAZALORE

They We the with now every week. continue helping Advisory in very peers remain communities. talk We and about engaged. raise They're awareness their Board to with though us to through care the health the excited medical professionals. Scientific work

the on lives. remain they're person the why and a patient It's that And And acute are aspirin therapy their about we in prevention developing secondary continue We from view, when particular to on and cardiology reach therapy, the both chronic community in the important? on strategy. to of execute the are do patient necessary aspirin areas. that's a engage that marketing that sales materials will point really think in our throughout we publication and we initiated and think

is that journey. really on strategy our So, focused commercial

can get through we post-approval, Rita talk the chain supply I terms think need what done In of from area. to

Rita O'Connor

Right.

So, process. -- the working we are on have manufacturing been

the the at So, steps Patheon we already and pre-validation we to were in advance activities engaging validation validate start in lines that. the next of -- commercial communicated are actually

all submit to FDA, by the And and we the we're accepted go. we once work that ready runs. going sNDAs So, Patheon they've schedule validation been to to are with

so and runs can to of And a that thereafter, production we in dose make forecast would this the of the that manufacture large quantities. the runs on couple to shortly then into both the we we from validation the get retailers. capsules we sure have And commercial do move based on strengths

be on post-submission. manufacturing busy pretty we'll front So, the

Jason Butler

Okay, the the progress. great. congrats Thanks again again for and on taking all questions

Natasha Giordano

Thanks Jason.

Rita O'Connor

Great. Thank you.

Operator

I'm this not questions showing the turn like time. any I'd at to back further over to call Natasha.

Natasha Giordano

that Thank to Thank Kevin. to time commitment you and you thank a will. like for forward look our VAZALORE. keeping We your great and meantime, these the their on with partners, challenging mission investors, your you I'd our know posted employees and for Have remain safe. progress day. to continued this I morning. wish our families In during you, we times shared

Operator

and Ladies does this conclude presentation. gentlemen, today's

and may a have wonderful disconnect day. You now

PLx Pharma Winddown (PLXPQ) 14 Aug 202020 Q2 Earnings call transcript