CTIC - Earnings call transcript Q4 2020

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Operator

Ladies and gentlemen, thank you for standing by. And welcome to Q4 2020 CTI BioPharma Corporation Earnings Conference Call. At this time, all participant lines are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised, that today's conference is being recorded. now today, hand Dr. would to conference I speaker your Instructions] like the to over [Operator Adam Craig. you. Thank go Please ahead, sir.

Adam Craig

Thank you, call. afternoon's this Gigi. And welcome to conference

and Officer. today Seeley, me are Kirske, Financial Joining David Chief Officer; Operating Chief Bruce

questions. Following formal call conference remarks, open will be the for

begin, not this we results Before to performance are guarantees making of please will Such expectations. risks that from on those forward-looking the materially that differ subject actual based future to statements current note may and forward-looking be during we by call forward-looking statements cause uncertainties are and anticipated statements.

risks Additional information concerning in uncertainties these and press today's release. contained are

This executed CTI launch. advanced and with further commercial pacritinib towards quarter critical U.S. approval on a activities

severe per thrombocytopenia than submission the of NDA less is finish on-track of count liter this touches for month. Our of rolling pacritinib with submission platelet XX,XXX complete. use the end the to the We nearly by remain in patients myelofibrosis

discussed, this twice [ph] with in including to day; naive reduction frontline compared milligrams in at PERSIST-X enrolled the PERSIST-X studies, XX% data study thrombocytopenia NDA these completed focus to a patients, prior previously the upon to a an the available continue and the manageable available Enrollment X the from and of and of will approval that approval pacritinib well have the expected In of for of report At PACXXX ongoing had pandemic, by the spleen accepts JAKX patients side-effects. improved, best to X Phase end tolerated in part severely review, severe submission opposed a and receive treatment receiving with based on the due pacritinib expect with a accelerated and with PERSIST-X and NDA least thrombocytopenia as a XXX data treated therapy, efficacy to patients patients we be to finding. population, of in pacritinib and primary XXXX. confirmatory Phase patients FDA we trial is the As statistically Phase to was priority has with should package the study the format exposure of with study. abatement studies, the completed If point, COVID-XX topline agreed [ph] XXXX. patients FDA in was in we consist reversible X grants In inhibitors. volume same of significant recently the XX% PACIFICA who X% were

approximately myelofibrosis commercial for access. well. had severe are sales, key and launch thrombocytopenia, To in Our marketing, have address this medical now a unmet population pacritinib preparations X,XXX progressing leadership the hired market medical Over affairs of of we patients. existing the third need,

awareness pacritinib the force. to of the we pandemic. our disease months This X year, we'll study market deployment access, Over COVID-XX focus in Last coming campaign, the field and will plus [ph]. mechanical the to assess study of of standard-of-care extracorporeal who COVID-XX plus patients trial of hospitalized patients. die membrane age standard-of-care or ventilation XX in The pacritinib versus endpoints the is severe placebo-controlled Phase in of multi-centered with progress comparing pacritinib our randomized engagement, in severe double-blind, study by hospitalized the and/or launched patients customer oxygenation invasive the primary on PRE-VENT response placebo proportion patients

to from expect mid-XXXX. analysis We an report in study this interim

versus indication of low to we acute without indication a quarterly showing of this standard to days resulted X the and that graft historical I is host over interest or the expected have transplantation turn forward an I'll in want of the of of year. reduction XXX an the as remains adding of touch acute therapy the later call significant investigator The meeting X/X dose X prophylaxis on American and now sirolimus in is disease ASH, look without in David in trial high, patients prevention Phase outcomes graft compared At GVHD. David? the the presented Society to this data study CTI in to to With host call Phase we December, versus the sponsored and use Phase concerns. compromising Before the been component investigating; providing progress The review data to rates financials, an update Hematology enrolling, that, to that turn David within now in was pacritinib from pacritinib that of study additional the I any first in our on new safety over review is financials. to our tacrolimus

David Kirske

Thank you, Adam.

$XX.X of our $XX.X XXXX. totaled million XX, as XX, million and XXXX, December to compared December of equivalents cash As cash

$XX XXXX. for net December the basic or for compared same for diluted cash the to and share enable the for million, million in to $X.X respective to our cash in period was of an loss loss No share loss million were current the December Net was the loss year-ended reported or fund the $XX.X the months $XX.X into $X.X compared operating second December $X.XX the months XXXX, operations as per for Operating quarter equivalents million loss for of per XXXX the XXXX for XXXX, XXXX. million period $XX.X same basic periods Net for the $X.XX diluted ended months $X.X loss this XX, expect well were three diluted per diluted $X.XX recognized was for for loss ended XXXX, and basic us XX, months We of $XX.X net and XX, share and and XXXX. million of for XXXX. XX, share three revenues $XX XX, for and or as basic and or year-ended and to for a and three compared loss of $X.XX revenues December in million, year-ended per million December December year-ended respectively, loss a million year. three while loss XX,

Adam. hand you to will that, back it with So I

Adam Craig

David. Thank you,

So an pacritinib of in the to we're the by to of be delighted the submission, here end to approval NDA potential for the accelerated be and the completion year. close summary, of for

in For severe are Operator, questions. remarks. patient with open formal currently This call underserved thrombocytopenia please our concludes patients for myelofibrosis severe the with use group.

Operator

the Ren comes Our [Operator JMP Benjamin question Instructions] line Securities. from from of first

Your line is your now open. Ren check open. Benjamin Securities, from is JMP now line Ren. Please your mute,

Reni Benjamin

hear Hey, good me, you Can afternoon, guys. okay?

Adam Craig

we Yes, Ren. can. Hi,

Reni Benjamin

now, the the you discussions agency in and regulatory be -- you as Have any by as this you're ball some a sort it know, this any is all know should Hey, changes? know there ultimately for way discussions to is be just it -- you we out I coming application, campaigns to taking the I'd just right year, of month. assuming awareness completed opportunity progress. this doing thinking you the I and think do is lot end of does that guys? approval; the Or what you want the you it the there can on ultimately things gets sort thanks disease with you look reviewed, can your this about of -- off launching, And mentioned love questions, back all application of color And -- will completion on launch when on. anticipate -- been court asked starting commercial you I much that happening to as Adam? if an of But the Maybe it? pretty application; the by but any from of with and potentially the there you're end of how remind and us further I've sort of sort more is the in build point? the in which ultimately, out? any anticipate you Do then, for panel as a -- forth, past get -- at you how congrats

Adam Craig

the think very XX believe as inhibitors rate to been respect to. very any clarification in pre-NDA the shows patients. pacritinib some very as review severely pretty deal I X%, through was focus to we Yes, the The good FDA other and certainly. to the very wanted There complete targeting to And those, data points. to the but was the extremely I twice with an the clear There to think us meeting. other drugs us it's the dialogue has to focus be disease and was of we kinase respect area the that with we of versus XXX NDA all clear safety us. and on the efficacy clarity currently, a clear; in Ren. of us presenting very day I is start that data we'll I the for to [ph]. addressed meeting, that they been had of were is referred has and our will correspondence draft [ph] thrombocytopenic label There said, focus them the major their of during that FDA, -- and I'll solid of that expected hasn't with it's around a sense specifically the was and us great similar milligram application data the shortly. think, because regard all process, been the That a panel, required our profile NDA Thanks the questions. during what clear application, with concerns about with dosing very mainly they with what in of With a submit to I really go SVR just

not moment, whether Bruce months. is say where we we for of we leadership at full the opportunity, this we into hired they've that the how being from the be point, should the point, there detail into we there and aid I'd however, out otherwise rather of at deploy market the end At we commercial so who's access the by force Seeley moment, them commercial on believe the the by about are, of have And key that. eventuality see too we by rather moment, indicate and working we have end month, the suffice much from then patients understand that a with a me it whether affairs leave if hear work, go they prepare at sales, the amount and to go the and they still panel that Currently, FDA. that. the So much will marketing, until in at discretion or the May, on a detail of coming not. should at can filing file identifying opportunity because of medical considerable not over don't just should and too hear FDA, I'd the the done But were our we panel, accepted

Reni Benjamin

Okay, enough. yes. Fair

get that you how in quite a just talk how be as Can about about should assume you I'll in maybe next mind, year. And updated we ASH pacritinib a threading ask is question regarding MF, last you me envision Is long to landscape As it one but changing don't little call how clarity. for this thinking see as fair I the GVHD, that, year? the this needle threads that the Is we more guess, probably it? of needle to pacritinib bit in related later then you the conference you mentioned by data bit GVHD. leaving, GVHD?

Adam Craig

opportunity I label said the expand going is Well, the I The potentially they've and shortly study for conducted to think The University going been data. and of Phase exciting versus And expect in has of X but use, host data graft the Minnesota the and indicated to the in to host we least very it's of the to data study an for focus been setting as our Moffitt is publication to we're acute the the other the pacritinib. by very interested question. at versus enrollment a there some pacritinib that the us and remarks, in out I graft Center come using is of at With I proof host, versus the well. as broader be has the syndication. think opening the this are host, of acute by answer your graft data ways very expand that drug using use moment main in ASH positive of of respect concept would team graft of versus expanding

Reni Benjamin

questions. the much very Thanks for Perfect. taking

Adam Craig

Thank you, Reni.

Operator

Thank you.

& question Needham comes line Chad Company. from next Our from the Messer of

Your line open. is now

Chad Messer

completing evening. being Good a thanks. and my filing. congrats question for on close Thanks to Okay, taking so potential

of this addressing You is labeling. to have was just you as given way discussed thoughts that mentioned appropriate just sure your past, I'm that. are your want on labeling. I know past a latest discussed can thoughts be have this wondering where the about I at on whatever safety in point, concerns. we make

Adam Craig

Thank in. awful is warnings to what through lot set, to After not data bleeding And the less the and black spent can around justification concerns the in data most you the the a or of box any entire the again. in of reviewing for the speak We interested you, safety previous Chad. safety labeling, gone time in we data and nice cardiac particularly address we a deal great data FDA which any the think the detail, the is we events. Yes. from warning. data It's precautions population, section, is in than FDA we've do primarily labeling of think an XX,XXX there safety --

black I FDA, very obviously, for not pleased within be But language very effect the negotiation a label encouraged very a profile overall, the can together, draft concerns manageable warnings to was box to So side will and to going data label at to we the FDA of this the address have and normal precautions looked we was review integrated we warning very the started data. that our proposal have label. others once and think pacritinib data, But when with predictable we the include the and as all hemorrhage. section in we're see of the the

Chad Messer

you've Thank on further with We've had on very the before Very base if thoughts a you. of but touched Okay, any on the and great. on helpful filing just strategy? encouraging. wondering FDA eve general just I'm here the EU this

Adam Craig

separate is indicated company, of that and Europe, our is and honest Pacifica territories. focus Phase reassess at myself complete review colleagues, the with UK from we has be be But regulatory like my UK with some our that Well, trial X last the the strategies breaking we in six position regulatory to NDA. the focus size time submit. once the obviously EU look they other has NDA a The the our the you, previously months given over in been continuing take will would the away to place, the now before to on entity. We're and

Chad Messer

say wondering my I'd just Okay, particular the just like But position, thoughts is fair looking back -- enough. And then your to cash here QX not get in obviously if just the on enviable. that. that have runway Anything appears super to for you're from options to notes about quarter, I'm last a shortened. if can the considering reason you there's address? at

Adam Craig

the going Yes, for already we're to has numbers your David presented, not thank today, comment but that that Chad, question. for on except you

David Kirske

Chad. Just one point,

our that that's In as costs, we build associated terms with accelerating of infrastructure. commercialization

Chad Messer

Great. right. All

Thank I guys. think you fair enough. it's

Operator

you. Thank

Adam Craig

you, Thank Chad.

Operator

from [Operator of Street line Instructions] Our from the next Thomas Capital. comes Flaten Lake question

open. now Your line is

Thomas Flaten

guys. Hey,

Let me add too. my congrats,

housekeeping of Just a couple GVHD. PRE-VENT on and

about? On patients. increased be to PRE-VENT we patient the think number Adam, still the right had should XXX study, thinking group up you Is I the interim that

Adam Craig

correct, Thomas. that's Yes,

Thomas Flaten

what the study the that's remind with Or Moffitt that us remind with you us of data you Do team your all going the your relationship is generated could access that on have are? U full and by team? you M then can to just And options what Okay. doing research? being in GVHD,

Adam Craig

X, a relationship. have on good the we data well, we Phase is do It's access mature. be We have access will currently, we when don't -- have but the don't

at whoa with the much it. move They are look we to agreement able be to as will here. Moffitt this do. want and the forward Minnesota We That's partners as in good

set host acute pacritinib us data. be on approval with potential a on we're pathway for we that have there it at and X. versus will X of a until and the the then is Phase may data, and current So the see the that for to we'll may point, graft with generating FDA. based won't discussion know data us Phase going the able to at We based the end if going have to reached be is look We're data the options additional look at drug be

Thomas Flaten

launch couple And up run the just end. to the Got it. a here a then year on by potential

reps mass for bolus of an the you people file junior [ph]. at the going Is a acceptance May trigger of spending, marketing into of sure once As there's to sales of hiring about your that company? folks be I'm that going to have we're thinking kind end what's be and to coming

Adam Craig

the bulk The for comment we of hiring is have after acceptance on hire. let that Bruce briefly. I'll

Bruce Seeley

at far them And Hey, the May. right. validation then closer [ph]. Adam the as the end mentioned we're Thomas, filing, to going the to you're The bring as the gate force as sales is on PDUFA concerned, of date predominantly, of

Thomas Flaten

on that, a if you're need on sales guys completed with number exercise that And reps have whoever you've know settled that ZS you final that to just using? you of or

Bruce Seeley

not we that. finalized in No, have now. It's process

Thomas Flaten

drug one respect how to And stand that? then with do we one just me. With for final supply,

Adam Craig

been very the always We we company. established, had plenty drug products ago concerns strong manufacturing. and has no Manufacturing have about some manufactured of a years already very actually, well component of

drug things supply things patients of have start of as and additional the We we'll commercialization first progress, and within manufacturing drug. year the then plenty year first for

Thomas Flaten

Excellent. I the appreciate congrats Thanks. taking you again. and questions

Adam Craig

Thomas. you, Thank

Operator

Thank to the no you for would showing back closing questions. like I'm to further Dr. remarks. turn Adam time, at over call Craig I this

Adam Craig

Gigi. just the everyone We today. for forward coming call joining thank like over I the to look to months. Thank further you, conversations

Operator

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

now disconnect. may You

CTI BioPharma (CTIC) 17 Mar 212020 Q4 Earnings call transcript