CTIC - Earnings call transcript Q4 2017

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Operator

Good day and welcome to the CTI BioPharma Fourth Quarter and Full-Year 2017 Financial Results Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Tricia Truehart from Solebury Trout. Please go ahead.

Tricia Truehart

Thank you, and welcome to CTI BioPharma’s fourth quarter and full-year 2017 financial results conference call.

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

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

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

concerning and the December call and Commission. the the XXXX, Adam these fourth to other the year Additional Company's the Factor contained information for reporting Company's filings ended Form the XX-K full-year, and reports the risks Exchange on Craig. Risk in Securities release the and Report the turn press in quarter over quarter results section periodic now and is and with financial Dr. our will of uncertainties XX, Quarterly I for

Adam Craig

milestones are company, and we you, to CTI build to be recently the continued well led have common regulatory public made This stock through next financed lean sufficient that us completed and two the afternoon. progress a focused cash Thank has on during goals. to we us year, believe XXXX good now over Tricia, has achieve and offering our and We preclinical now oversubscribed years. an of our to carry

financials. and myelofibrosis interim the XXX,XXX in thrombocytopenia prior detailed milligrams the was the update to EMA, are BID. have the which dose treatment a benefit the we with request failed medical meeting address removed will to just clinical counts our with pacritinib pacritinib patients clinical discuss the XXX the List of update of PIXXXX on that prior ruxolitinib were setting. to Last Phase as patients myelofibrosis of the designed expected the once we developing milligram the data in PACXXX from dose last trial XXXX, patients in This dosing, for line pacritinib. for plan provide application hold our has corporate of analysis NHL. the the of the a of and of initiating is less was well the for used CHMP. and working evaluate two XXX submitting JAKX include a results analysis in relationship the III evaluate a dose patience Next new of a most data initiated Once III thrombocytopenia. regimen The platelet that received them by favorable call with now the and milligrams PIXUVRI enroll have relationship granted we is the approximately that believe profile. the myelofibrosis have we and dose in is extension the the milligram our all PERSIST the analyses as XXX efficacy pacritinib further study need the results trial twice who day, validated to inhibitor, II trial with pacritinib November, lead we turning expected primary generation second to completed, development safety the MAA XXX presentation responses the who quarter quarter microliter And FDA treatment for data an next pacritinib unmet Day PACXXX has three candidate exploration a January XXX ruxolitinib expected myelofibrosis. the FDA over to of of July, XXX topline Phase in we risk enrolling been brief milestones, analysis myelofibrosis at with response dose more levels; marketing provide order the David day, and therapy. Pacritinib, XXXX. BID development month, I including This in Phase interim for the Expected status pharmacokinetic than important Subsequently, to BID from or interim before the with to programs we PIXUVRI up authorization in trial have ongoing anticipate After and/or the of trial, the patients have for with review secondary well the to study first process PACXXX dose Questions topline successfully in to development second treatment is with who response received by is patients quarter, for CHMP study. of and

the We expect the with third responses May expected in CHMP the to of submit Questions XXX quarter. our to Day List in opinion

and authorization. label regarding the licensing new Europe agreement marketing in study of the expansion the could XX In to being rituximab of post our collaboration gemcitabine and provides like Grade support CTI line we and two XXXX potentially and of of XXXX Lymphoma agreement B-cell fourth extension. the in III in rituximab and authorization with Turning commercial as Phase treatment comparing second discuss topline in X B-cell year line and second corporate or commitments the enrollment granted Servier the of last has leadership requirement rights positive, PIXUVRI, rights. will to in the minute approval and look August a If Servier conditional last some forward CTI and to BioPharma change results non-Hodgkin markets aggressive in April conducted Follicular patients announced was aggressive with trial the all for third it's to CTI made NHL which a post-marketing months. PIXUVRI, over now to the the lymphoma, completely conditional quarter except is XXXX. where I’d just the This with U.S., a PIXUVRI take change a

as began late Company and the I CEO of asked in XXXX XXXX. you March, Directors as working a the join with of by to in was Consultant Board most As know,

as to in joined Bruce a Secretary promoted and the Consultant Seeley September, CFO and also Kirske David CFO, XXXX. served Chief since to had and Chief Operating as Officer appointed Officer XXXX was Administrative Company's in was XXXX. & Commercial Our

quality Importantly, years as the last Directors in Parkinson. over them Chairman, February three year, of Dr. we the the significantly million our stock better David Board, science have public new Metzger three on strengthened biotech management numerous to added our well we space. our from our Directors reduced the and pacritinib. Company oversubscribed the life of with underwritten XXXX, gross closed Xwith experience participation proceeds cost have In focus new year, of All investors. sheet Fischer with on bring many offering of we and and clinical including as balance development Throughout existing Independent Laurent high Michael $XX

have a the milestone XX, In to we received $XX year, payment milestone still sales. from of addition, first two part in payments XXXX last Teva June as over TRISENOX related was million the our

updates. a The of I to ask was now related second in provide approval, XXXX to February David will a TRISENOX financial payment the U.S. the milestone front-line

David Kirske

have months pacritinib ended in months to XXXX. in and $X.X for the our respective Thank to $XX.X product million zero sales of primarily XX, first you, in of $X.X the which quarter months and XX, compared XXXX issued related complete of recognition PIXUVRI and December the and were $XX.X respective Servier in XXXX, for periods in XXXX. for periods to and the of financials PIXUVRI million decrease the revenues under due in million the the with compared million the is milestone United compared were to respectively, $XXX,XXX $XX related for million The primarily in the $XXX,XXX and $X respectively, except total revenue net quarter to nine for details. XXXX in XX XXXX. is now Net product will revenues Adam. and expansion rights today XX release for in quarter review XXXX to agreement markets the ended press briefly sales fourth of States. September to for periods third million decrease all Total The XXXX. April for our I they the Please refer quarter fourth XXXX

decrease our a and As lower costs. to XXXX, and through Adam development personal mentioned, manufacturing reduce costs we took including significant costs pacritinib in steps

ended to GAAP compared operating fourth the and for loss in our respectively, was and quarter $X.X loss XXXX months XX, $XX.X million of such, December XX operating million XXXX. As to respective $XX.X compared periods million million $XX.X

costs December impact subsequent net for of Some per compared XXXX same a were $X.XX in to million fourth the was was XX, the loss are net near-term. million same loss to period for or of $X.XX or quarters the of taken $X.X benefits the for million, to million the implemented the $X.XX continue XX net the to in ended share, per in loss The loss to actions expected net share, quarter The for or of reduce per $XX.X share per XXXX. months $XX or $X.XX XXXX. a compared $XX period share XXXX that

cash balance fundraising $XX we at equivalents totaled XXXX, Turning to a over mentioned, million XX, compared bringing completed as recently $XX and as But in million of XXXX. million gross cash December XX, successful to the $XX.X sheet, December again in proceeds. Adam

incorporation shareholders, mention this stock. merger strengthened was CTI CTI’s our an a of from greatly our the I agreement that Italiana XXXX, State changed exchange. of of of January partnership would the of months $XXX triggered approved sheet the past from the milestones the and now successful through million. is fundraisings automatic And Borsa which a BioPharma the totaling Washington to Importantly, been State to stock NASDAQ Corp like over has common by balance sole delisting Delaware. the listing XX common MTA also in

with back Adam. that, turn the to will call now I So

Adam Craig

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

Operator

Instructions] JMP Mike Our will question King [Operator you. first with come Securities. from Thank

Michael King

little quarter, pleased upcoming Hey see for first I you the for you could a Adam I'm joining guys. just PACXXX, to the to wanted the question, and time. and Good be taking bit afternoon. if of What just possible that the talk Thanks guys the how will statistic just arm account fact there of them if point in interim [indiscernible] and happened those to for view? from dropped. outcome the are what you patients in a in the second has

Adam Craig

safety which Yes. were Mike. the people, parts, treatment each to for has – three your doses, different the Certainly, To are of which remind you people question, of each which arms, so study thank dose three remind analysis of different time. curve. identify together the the the volume XX-week interim purpose is with spleen is data [Fetal] And that are with an arm to that the at parts data of response

we per launch [Indiscernible] next we remarks, written an and plan an the conducted a independent interim assessment. as patients the in per at have closure the the minimum can XX dose during survives to patients will conduct the patients committee to of of make IDMC arm no analysis be an the enrolled if [Indiscernible] at arm will closed recommends in and arms that the be six is levels. treated and will data be the interim said analysis So safety continues up we quarter. that arm, more then arm

Michael King

[go So study? they will just off] then

Adam Craig

the dose Correct. have fetal. at because levels to That’s treatment considered be how will the [indiscernible] been

Michael King

Okay.

just other of FDA the final follow-up view, requirements? requirements FDA from speak is guidance Or you demonstrating you knowledge of from benefits that. prospective will as your have Can So might there if request to satisfy to FDAs regulatory any from far from sort point or on PACXXX as the risk a that and pacritinib? a to be

Adam Craig

Yes, certainly.

the yet. haven't met we with So FDA

analysis once FDA We data. the have will said we we interim have with that the meet

on One that findings what requirements line minimally that, effective and approval within the dose, data are We is will where line effective the a opportunity the to looking to in following of indication meeting, should have first interim, is line the we was and PACXXX have identify of second we drug. hope of go minimally second to Once at to study back then that, believe the trial FDA the the have discuss further discuss designed on to that’s that clinical PERSIST-X designed program. bear do the the second we and and interim the the provide And data the hold to dose. we interested the already the data At developments trial. thing. the for is we moment we

know the PACXXX you We purely is have line. as additional, the trial second – PERSIST will

like we So about a to NDA once as it potential trials will we at data point yet, in discussion interim said, to that that the the will had we have request data two have hope the as and we meeting we we the will But into summer. we with and no pathway. would have have progress we FDA haven't discussion from house, more

Michael King

back jump I’ll and questions the the in queue. taking for Thanks

Adam Craig

Thank you, Mike.

Operator

Our next Matthew question will Andrews with come Jefferies. from

Matthew Andrews

changed most Thanks arm, this so I the noticed of ask to from now year amendment the agency potentially your afternoon. this couple up recent made XX interim from per or second has for sizing to the X with between Adam, and XX. sizing analysis questions. that in when good you've Hey, protocol the the the presentation you chance you officially of to then earlier a What's FDA? interim? the to agreed when design changed And the

Adam Craig

patients when could joined Too patients changed I company many a to at and made lot receive program that before referred took the it detail. the a pacritinib There analysis conducted. looked drug was that than over What CEO became without XX patient as the the obvious was size. sample a the study a the And the a aspects way look interim [part]. I dose over we formally as who too many receive could consultant, we potentially at rather develop of that wasn't potentially many – were interim who working you in

one So a ask that we went to treatment them aren’t as a run don't where to is to whether Group benefiting the company because to and from statistician could adjusted trial want the number be arm. what we patients our back do Biometrics of

motivation over joined we really point look when interim we reduce questioned, analysis. overpowering just whether to was the – to and some just we So the we questioned I to and adjust at improve see it were everything without around time enrolling we looking it

any with comfortable what the to enrollments about Matthew question recently, think And amendment is the going six, briskly We than the it's it interim. FDA powered the because our protocol dose. gone the receive then the from minimally will when to but to sample more actually submitted comments six. did be question that very not be amendment back quite It's six, effective the we're than more FDA. for we change second in we is answer adequately So the has did we size included submit

Matthew Andrews

issue anything to to aren’t than So if responding arms. it's safety two of expose or need a the them one patients potential more of risks. No to

could the it? and right with about the that you to efficacy answer the smaller, is way get So think

Adam Craig

to And is levels Yes. because those is way dose We be, to quickly it’s identified one the response patients it is patients having that stop the of there been possible to one, important – designed there's poor some trial different has efficacy where then want do not as that curve. and allow to to would I the as arms benefit. the have if path dose doses think future enroll in arms

Matthew Andrews

you thank one and more. Okay,

relates Day as XXX analysis, interim XXX response summer? of Day that potentially the leverage Thanks. over receive the questions this how EMAs to – could your it As you'll part to the you

Adam Craig

you, Matthew. Thank

questions direct the from any the reviewers. had haven't We regarding interim European

see interim we and hold was is since we data the study. first think data they of the the it clinical will be However, time lifted. in are interested importance the And report the I – the

nearly XX that ago. So months XX,

will time the on see the we to show are think to first it back show I it's have that think – be and track. important we that Europeans I So we

able we to run we in and that population We’re can understand forward. trial a the move that

So we results them, will haven't the for they them. share asked formally but with

Matthew Andrews

Okay, great. Thank you.

Operator

Needham question Messer Next, with a we’ll from take & Company. Chad

Chad Messer

for Thanks. taking Good question. thanks and my evening

I the XXX it that a has pacritinib, what than of a I’m best way better Phase look that trial out dose the ongoing know the in if turns the lower But BID you milligram interested like, might doses that On forward risk-benefit. think has II we're profile. hoping risk-benefit indeed

enough would registration? think the path EMAs that any FDA the about to and patients think forward thoughts you with you discuss affect if you have a If

Adam Craig

was the more enroll the the and more I Well, if would of I that with would XXX something has interim. milligram I dosing BID we patients That dosing certainly – we get level to arm strongest FDA the discuss imagine – we would to the level expect expand data. and would

we've expect the we the up we've and few been As sites for weeks sites road very last be recruited show, trial to number summer. in recent during around saying XX we've the to over of by the our aggressive been

we And can a we size treatment of need do to the do so increase arms sample possible. as quickly if of as one

with U.S. as increased European dosing had and the of discussion discussion them way. and I've and I haven’t milligram a to to the planned a they I from for very think application the that's with the to would sample potentially have comment conversation size, along I view, had point is about FDA XXX them. by respect focused review. So That the something schedule. potential something ask that's with question we XXX for With – Europe, discuss can't was be and The which regulators difficult not for. would we where that the around a BID

Chad Messer

just Would and the between and go discuss EU a on to try then that based to or having U.S. failure different you label? pass plan unnecessary? assuming Is agencies? both things the Great, first is well, that sense with they’re and difference on obviously back go evaluating, sets RUX it potential makes to EU data that a that labels something the in

Adam Craig

on really the and to going considered label. We’ve is depend

One line actually Bruce between Seeley this. pretty the comment on second have I'll many line the things population. patients, is overlap thrombocytopenia, in thrombocytopenia and of clear there's the the patients to so In patients a let that second of substantial

like very, would they're So comment? you to very similar. Bruce,

Bruce Seeley

relative sizes rare to us isn't I patient I a that disease second thing line the could it's are same, only with that thrombocytopenia. get the The tell market that is add physician mean

difference big the a going there between we so And be don’t that feel is to two.

Adam Craig

Bruce. Thank you,

Chad Messer

Okay.

my appreciate you. even So that through to step. maybe questions. your Thank to to I’d go answers unnecessary

Adam Craig

you, Thank Chad.

Operator

King from from will Securities. we take Next, Instructions] a JMP [Operator Mike follow-up

Michael King

further the follow-up. previous questions, say anything could for baseline the the the Thanks of PACXXX about terms just you of counts, they're study wondering of meeting Maybe shift patient expectations length to your or kind guys. in two characteristics taking Hey treatment, if in the patients population? been that in platelet et cetera or and any whether prior there has RUX of demographics

Adam Craig

trials No a the on has time, ruxolitinib ruxolitinib see have they X a ruxolitinib on much for thrombocytopenia at associated developed that a low or a with and counts, we milligrams on is it's and been spleen had uncommon of our very patients the doses will they the two have and thrombocytopenia – being a we months six symptoms are Typically has platelet not expectations. that to year same. over meeting And patient time often patients to therapy. who increase dose patients on who have and have ruxolitinib will we'll that’s and our that of Obviously in size have study of there's from MF. with lot therapy, an will old reduced

– receiving For received patent in patient very is this having with common. RUX reductions our thrombocytopenia dose is

trials, noticed thing now have also transfusion who a blood The have lot other requirements I've on a as have patients who anemia we well. and of

is to and who us now doses our advisors, symptoms, much an in advisory lower prescribed symptom, our a originally out have clinicians what tell thrombocytopenia. So there there in and this keeping patients and high have with very spleen very, board anemia [indiscernible] are who ruxolitinib that

patients should… it's patients Okay, well is very question a Anything this very recruiting would it we lot we the think second fit study appear line the So answer there because out who much there kind directly, Mike? of operator To recruiting And recruiting the much. study I expected. else, of setting. your is are

Michael King

That will do.

Adam Craig

End you, Thank Q&A Mike. Melissa? Okay. of

Operator

to question-and-answer remarks. additional for it our conclude will back I will turn we now session. time, this any management closing or At

Adam Craig

We that and the the In CTI Melissa. pacritinib year joining you to you, programs with year. the updating thank undergone end. and the through for with forward for summary, are today. Well we look Thank changes over last pleased months progress has additional over PIXUVRI Okay. the call coming you

Operator

for our your you conclude does Thank That conference for participation. today.

disconnect. now may You

CTI BioPharma (CTIC) 7 Mar 182017 Q4 Earnings call transcript