CTIC - Earnings call transcript Q3 2017

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Operator

Good day and welcome to the CTI BioPharma Third Quarter 2017 Financial Results Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Ed Bell, Investor Relations. Please go ahead, sir.

Ed Bell

Thanks, and welcome to our third quarter financial results conference call. our in can our the at reporting the found corporate release ctibiopharma.com. and homepage Investors press financial be results on website The section of

for conference remarks will management, formal the Following be by opened questions. call

Joining me and Kirske, our Officer; Financial Chief Chief Operating Craig, Scientific Bruce Chief Jack CEO; Seeley, David Officer; and are today Adam President Singer, Officer.

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

XX, call ended Securities for these is with Risk in and uncertainties XX-Q the the concerning turn Company's Commission. press September Factors Company's contained section the information of Exchange filings release and XXXX, report for risks and third financial periodic the on Form the other the quarter, over the Adam. Additional results and quarterly to now in reports will reporting our quarter the I

Adam Craig

Ed, and afternoon. Thank you, good

opinion call to the David expected CHMP The next Earlier myelofibrosis Application for under Over at more company and is thrombocytopenia. to the review a the progress clinical made turn treat over a we've and the first and streamlined clear pacritinib a regulatory of Board the both June EMA, with discuss application focused executive and I’ll submitted strategy, I’ll and robust progress, with Marketing level. year, with a becoming leadership last organization months, then year. patients clinical the to regulatory we in in six smaller, significant at the for financials. this the currently Authorization

ruxolitinib unmet Given is with for the that had approval those market or treatment-related including the pacritinib we with opportunity believe thrombocytopenia. prior disease-related significant, patients pacritinib therapy the and have either medical need who myelofibrosis, and in of

designed trial. XXXX. the study at of milligram data dose early relationship trial, planned by we in the FDA requested response the the announced, was initiated have to As of hold, PERSIST-X evaluate pacritinib, PACXXX PACXXX is for time a analysis clinical used an interim previously XXX dosage the the including the BID

in trial the enrollment Moving PIXXXX comparing we PIXUVRI PIXUVRI, of aggressive completion and This quarter, rituximab in and of being a is the the of conducted requirement trial have data potentially XXXX. authorization. announced half of trial. as of rituximab broader setting Topline been support the conditional the first If expected earlier on and the with a are and post-authorization NHL marketing gemcitabine results indications. B-cell to in positive, could was driven

consultant, the promoted a a I turn call was to as financials, to over review I him the a CTI to of summer, would over first short David CFO. introduction. for like joined David Before the recently give and

meet call our As a the and in in primarily David companies, provided resources turn in management near-term joining biotechnology David instrumental CFO, Since as have public David. over making financial to private well With the reducing we and I consulting manufacturing. has and been to technology sure costs services as that, has the objectives. Company, to

David Kirske

respective to in and months in ended The losses $XX.X quarter loss release Net pacritinib XX, the operating for Thank XXXX. September milestone for lowering and third for the of and except revenue of third was the development $XX.X details. nine third zero compared related for $XX.X $X.X XXXX is in to and the have million nine to the the respectively, refer The in and of recognition in million $X.X sales third general administrative periods were expansion and in for nine related ended the the and in which million, and $X.X losses ended nine $XX.X April review respective million the United under months now you, will XX, complete million compared to the to the decrease as agreement XXXX and and product operating net our million to the reduction for States. and expenses. first in in and This periods decrease GAAP revenues costs total all selling, XXXX. due of to periods for XXXX. personnel our quarter Adam. in and September decrease the PIXUVRI development to is XXXX. decrease Total respectively, pacritinib were $X.X respective product The primarily research quarter periods I revenues million, manufacturing costs. million million months for months quarter compared of compared of as in $XX briefly XXXX XXXX $XX.X press months Please today to for for in costs, PXUVRI periods primarily the respectively, million financials the $XX.X XXXX, is due Servier the quarter to XX, in $X.X XXXX. million XXXX, well with was XXXX issued the sales nine and related XXXX Operating September rights million, primarily markets, they in for

September to a million nine loss loss continue or share, of that per near expected $X.XX $X.XX of $XX.X term. the to in XXXX. the the or the the per to per (sic) months loss period of million] were loss net subsequent per share, same same for $X.XX benefits for or the share million to XX share to actions for costs net a was quarters the was taken compared implemented XXXX. million, million, or $X.XX Net $XX.X XXXX reduce ended quarter [$XX.X third point earlier impact compared Net are XXXX of $XX.X in XX, in period Some of for

the to Turning sheet. balance

it now to cash will cash With As of September Adam. XX, turn and back XXXX, million. totaled $XX.X I equivalents that,

Adam Craig

That Operator, formal David. you, the for remarks. questions. call concludes Thank our open please

Operator

with first our Andrews Matthew take Jefferies. Instructions]We’ll from question [Operator

Matthew Andrews

Hey, good Adam, couple of a questions. afternoon.

all, PACXXX? of patients for and initial the you on us the enrollment the First in status update the can pace XX of

Adam Craig

Matt. afternoon, Good

details going announced, not on give enrollment study But, say Matt. we should specific we’re as call, the to So, June. opened we’ve in that this

enroll will We but And continue number of to we’re sites open sites year. activation continue we significant We’ve in the still of a phase. the patients. opened to the for rest

new update Our only based provide enrollment around also this not but to PERSIST-X sites are the trial not specific But, call. going we’re on sites.

Matthew Andrews

Fair Okay. enough.

potential communication to data interim on around as of the with FDA? SVR XX those QX, sometime update what -- As interactions as process data it investors relates you well may thought is in the how interaction with

Adam Craig

will recommendations think, we one of a a the the the as that’s certainly or announce been of minimum, the of one has whether is arms result IDMC, of as I arms shut -- the Well, study to level different three at is be to dropped that’s and in the designed But expect dose subject there levels lower dose a we data. to particular is obviously test -- the interim. do more

pathway. overall FDA obviously, depends with we discuss data, If the have it shows. go clear with objective, really So, it the FDA. is -- we’ll it And the and with possibility that there and will is approval the what respect the is no data how we identify information a an to to eventually need, other

FDA. hold points that or more However, meeting if on we’ll are with are discussing needed, there data the back it

as depends IDMC the on -- to minimum answer really say data, answer depends do expect it your what dosing were, with the to question, the a we respect the different recommendations but So, to the levels.

Matthew Andrews

whether pathway view at get the then, on potentially was day-XXX, expect relative conditional or you transitioning that over to to a MAA. PIXUVRI with clarity if to all? like when the And pacritinib -- full Europe this under Would CHMP’s occur, be that would approval? be When do would day-XXX, would approved

Adam Craig

is today, the reports expected of data will in one around always this two both and day-XXX, time will the is conversation and of one or of way well hold if at the the But how where process I get which And in next April history is review we other the detail going approval But review time day-XXX, conditional caution, national something on. expected these back, drug it points Certainly, indication it's we're been co-rapporteur has evolved later we of not to the the not this an with a there’s Well, the later respect considered should we've U.S. the we’re we’ve necessarily something be year. process. is clinical which have month in during the have because with set surprised at would approval. I to rapporteur announce. reports had

the reporting… opportunity it’s the process, very now and or that not the as do intend have I fluid, with co-rapporteur -- of day-XXX process discussions are to a make with and During very fluid review lot announcements day-XXX Because, and said, the need respect we’re to we we and as very any forward. discussions rapporteur moving to and a far in

Matthew Andrews

lastly, about have then off be just U.S. some Okay. FDA potentially relative can that talk may hold, global licensing discussions pacritinib you're having you to timelines EU clinical rights maybe .rights ex-U.S And for or relative to you and interactions? any you now potential

Adam Craig

this, We to explore continue Matthew.

we pacritinib. bring any We strategy include do And to It moves area, reinvestment a which to or continue this interest on, and certainly partnership. best This we’ll expertise activity may the as time partnering report is evaluate that a haven’t made potential Europe. for would something if partnership. we a final of operational to is licensing on in able decision start Europe, in

we our For and decision. made options we are the haven’t exploring just we moment, final are -- a

Operator

you. Thank

Bert We from will a take Hazlett BTIG. question with

Bert Hazlett

be And amount bit, a the well. again, as that’s David, process of what’s discuss With think for How continuing a throughout little long year. to only Thanks you the continuing? happening, should regard I where quarter-over-quarter there management, granularity to you. to questions. pointed guess but we coming significant more taking with little reduction, you a Could of it being this from? to Thank seems not expense as year-over-year

David Kirske

year Thank the are that We quarters. will process. in we progress in near-term this well made you, managing footprint. Well, significant corporate overall point, our by continue as costs personnel reducing costs budget this at our in anticipate as that But, just Bert. we

to are trend But, our seeing we anticipate that what and will forward. we be, will still are now, the expenses So, trying continue. going noticing

Bert Hazlett

changes and if material at Company the the levels comment at helpful Company, guess then been and forward? going you and the have recent just question. Thank the I If on impact might management to there’s well. about to bigger ones appointments that comment Board And to what for to be forward are going and just talking that other ability Okay. that that picture in -- been a would There some an mean as the how important the we’ve ability that. levels. there’s an Chairman on

Adam Craig

Yes, thank you.

the importance of changes I Board think for -- the highlighting changes. you thank the

I significant. they think are quite

who’s lot us has Tobira joined Independent who Board has -- is experienced now A who to Director Allergan. Fischer and biotech Laurent of role an joined true of professional and independence which obviously Chairman, new a our a Chairman, the the expertise. is have We and brings he

In that, that, With clinical three on the have addition to Metzger of down. expertise have Syndax the Board and Parkinson. from members we and stepped Board Board have the David of older we Michael

Board of has a expertise, the clinical both directors in input lot has significant So, of operations. independent and and development

you important a Company governance. think highlighted, high reinforces standards change to in as and I So, operate to the of our very very, corporate very ability it’s

Operator

the additional remarks. That I turn Craig concludes back today’s for conference any question-and-answer Adam to will closing or session.

Adam Craig

therapy can summary, be on regulatory call joining fronts limited who clinical forward, have myelofibrosis treatment Thank both Thank the a you. for for continue to options. it you today. important we we as move and very In believe pacritinib patients

CTI BioPharma (CTIC) 6 Nov 172017 Q3 Earnings call transcript