SPPI - Earnings call transcript Q3 2021 | Spectrum Pharmaceuticals, Inc.

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Operator

Good afternoon everyone and welcome to the Spectrum Pharmaceuticals Third Quarter 2021 Financial 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 follow at that time. [Operator Instructions] I would now like to turn the conference over to your host, Mr. Kurt Gustafson, Spectrum's Chief Financial Officer.

Kurt Gustafson

good everyone. and operator you, afternoon to Thank Thank Quarter XXXX joining us our Third today for financial you for results conference call.

financial and our quarter earlier third results was release Our sent this afternoon at is website on available www.sppirx.com. press out

from Joining Pharmaceuticals Joe and Francois will CEO, Medical Chief Spectrum Lebel, me and call our President Officer. be the Dr. on today Turgeon,

inherent and release. known unknown periods are Before which not in them. over necessarily afternoon. future uncertainties statements included statements. forward-looking and to Joe implied the any statements notice to we hand differ regarding major involve CEO forward-looking that let statements materially get started, Spectrum. forward-looking such call forward-looking Such or of of With results reliance on These the and today's these I expressed performance results This press that, or we would financial and me this of should future emphasizes like from undue placed by performance and in actual risks risks not performance to reference projections make future notice uncertainties, may in be Turgeon, will cause guarantees statements the

Joseph Turgeon

Good I us for thank and the call in on today. Kurt. you you, really Thank interest afternoon, your appreciate joining Spectrum.

to the identified remain poziotinib start NDA issues second ROLONTIS in focused we and priorities; manufacturing close of to in we end by the submit As correct CRL. on on corporate the year, the first, our key FDA to the

deficiencies issues no finish for At addressed the resubmission. the are at adequately and at issues cited substance with the a fill were longer ROLONTIS, anti-cancer gained meeting we the the facility Last of CRL item a facility. and in clarity site myelosuppressive finish neutropenia update A Let drugs. understand to in me better been fill identified treatment start had we that The had patients with CRL. our that the FDA drug the on that meeting, drug for an month receiving the Type gating

all drug to cited one, facility, the we the expect with today we addressed the CRL be the deficiencies as completion, re-file remediation Hanmi thereafter. has expect successful to of shortly by Pending completed the Regarding of in end the exception substance year. of would and we believe that the

A six-month Our of be an review the Type FDA expect clarified part We'd also onsite a submit. conducting we meeting resubmission that will once as process. the inspection

as While be and the Hanmi monitoring resolve market is issues working GCSF long-term, adjust we associated to prepared the are we'll with evolves. the the long-acting market business plans to CRL, our continually

to have over late poziotinib, our pipeline. other the asset top submission shortly. file shift me priority, the stage to let we we remains The large which Now of focused expect in NDA our

program continued patients naive in addition, on well preclinical to cancer In data data Spectrum's as has clinical lung progress make with with treatment presented quarter in pozi combination this poziotinib inhibitors. solid as KRASGXXC

a turn update it to Lebel, detailed going on development over CMO. take our Now clinical I'm more away. Francois Dr. the get call our Francois to Dr. progress, to

Francois Lebel

be glad Good with afternoon call. you today's I'm to on everyone.

poziotinib NDA our dosing Fast X of cohort It trial. planned based from the weeks. clinical positive our Let's for under our coming of q.d. start be the with Designation priority. top on with data Track submission ZENITHXX The is will

mg great exon XX indication X.X. a cancer unmet poziotinib the months non-small of patients included treatment awarded to patient Median tyrosine this Erasmus X.X study cell the XX%. an response will Paris, Grade submission need. to review interval first AE previously believe cancer common on using Dr. X.X was The oral cohort has ESMO area [ph] We Cancer rate insertion was of and ORR that of oral and metastatic during. that in Our the was starting of observed, very study also were of The a with an of events treated lung the kinase quite from an with control XX in to The HERX received months, was first were Rotterdam lower for of in months. X seeking Cornelissen this recent in XX XX locally XX% patient diarrhea, confidence the independent progression-free or dose non-small bound and indication, be pleased RECIST including be complete from adverse medical typical and at ranged in was results potential as We most Median the XX.X%. HERX studies. XX presentation safety inhibitor our advanced harboring rash, a ZENITHXX that for use evaluated from treatment cell X an multicenter prior mutations. efficacy exon q.d. X delivered XX.X were of market pozi the centrally by patients late endpoint paronychia. cohort breaking seen insertion Institute mutations. response primary in data lung duration were This with the presentation Conference with months poziotinib. related was X.X of an disease was strong ORR were committee criteria XX% image The survival stomatitis, naïve

X profile patient pneumonitis grade Importantly, was one was only predictable grade X and X. manageable. with no or safety seen The in

HERX, b.i.d. signaling a we've EORTC potent preclinical impact These presented patients synergistic X first inhibitors. HERX, in mutant when specific KRASGXXC schedule. when Erb of family demonstrating data the patients in KRAS inhibitors dosing combined MD these AACR synergistic data proteins. cell showed with combined meeting XX triple been highlight mg importance KRASGXXC Anderson The of pozi HERX results of pan of preclinical the the inhibitor of line. was the the dosing inhibition At that October, with at NCI Following and EGFR,

over of quarter now our Kurt make keep on key third I continue to it balance will posted a year. programs we you turn achieve discussion the We milestones to the financials. and as solid progress for through of will our

Kurt Gustafson

Francois. you, Thank

quarter expenses. $XX.X ago was million was versus looked SG&A XXXX million million $XX.X development due we've versus third $XX.X to for $XX.X the expense of tightly Our in ROLONTIS a lower year million year R&D previous the control related activities. as more to expense these

million Our securities, quarter per or or $XX.X in more plus marketable share was per the million $X.XX year cash $XX.X out June million XXXX. $X.XX On securities backs the in burn ended comparable share of approximately share to XX, $XXX third compared We prior period. per the $XXX costs million Operating at $X.XX cash quarter XXXX. $XX.X with was for or loss prior lower in million for change now equity share, closely. call the This $XX of to and million. back With or our was a non-GAAP to value Joe. period which over stock the than net looked that, $X.XX compensation hand the versus in $XX.X as we've of me let the primarily quarter loss the million a loss versus manage basis, quarter is cash for per our quarters

Joseph Turgeon

Doctor you Kurt. you, and thank Thank Francois,

As all push programs to see, can diligently are working we you our forward.

I'd that, submission towards if it. resubmission open on to goal call We NDA to are progress for making poziotinib well questions, of remediation of our With up the that, please I’d appreciate like Operator, ROLONTIS tracking you could do great shortly. our efforts

Operator

of comes question now open. Cantor first And of Young line your is from the Fitzgerald. instructions] [Operator Alethia line Alethia,

Alethia Young

data do question. guess I Emily may think for you any taking has during then the also the Thanks is, but be to how can there is our COVID in re-inspection CMC cohort risk for for you poziotinib? on requirements? the And when this you see updated kind after question the for guided person, Hi, first b.i.d. quickly Thank submit do of comment X Alethia. on re-inspection and they can could if is you. of we the

Joseph Turgeon

hear Emily, to good from Thank you, you. Sure.

First don't know going I answer at to future. post happen all, of the to COVID, the what’s in obviously,

to end we first What mean remediated As can did should quarter resubmit. everything say inspection. to we I on-site want the stated the do which tell of have an would FDA today I earlier, sure to early The year, could happen what they future, by in can going I'm right though an COVID will example, there, as to so not but you we travel can have you you is actively, people now, travel Korea. certainly Korea, the

so the as the question. it doing speak, of that's we’re So, first part we

know don't can the tell would that we months. six take when they would months Inspector. I it six a exactly review. would mean it be So, you send doesn’t It

So, any file, back send we Inspector after could time to they an re-inspection. do a

Francois Now, as question, as X that? why far don’t cohort you take

Francois Lebel

questions. thank Alethia, Sure, you and for the

data cohorts let you the as for our can right data additional you now, get we need I'm we of we dosing the as the NDA is we'll team a So, as understand and you, will in analyse matures all have enrol. to mature is continues X, open And the NDA further, including cohort to and posted, now, which we date some the sure really on once it immediately. the but know you b.i.d. don't focused keep ongoing so

Alethia Young

thank Great, you.

Joseph Turgeon

Thanks, Emily.

Operator

comes now question Jefferies. line of line Maury the Next is Maury, open. of your Raycroft from

Joseph Turgeon

Maury. Hi

Maury Raycroft

Hi, and taking on progress. Joe, for hi everyone. my the Thanks congrats questions

second there on include need bit going line HERX are you before if filing? for to And to any what talk NDA the exon just more that question submit completed you patients? filing about filing, just First this factors specific little could gating XX more a in you’re poziotinib be the

Joseph Turgeon

don’t that? take Yes. Francois, why you

Francois Lebel

the that from X. so allowed dosing We next deck indicated some will of to here, go us be following to in Sure, we I in. the discussion good this that hands so data, they preliminary The in to X before among expect is Agency able all core the before, of data couple in others the add -- weeks. we’re is the on and file have b.i.d. communicated obviously as shape. data indicated cohort Obviously, and cohort we as with

based X, XX to of is summarize, It’s that we here. NDA over studies data a the there's integrate. Although cohort had large like we on body had

the here, activity going your on So, I that's of that’s question. answers part that hope but

that and from cohort as submission b.i.d. be in So, it’s q.d. there some well. data will X data

Maury Raycroft

you final you it, for cut-off, the for can filing data working the is getting or Got primarily point? clarify on still that or up a the and off, cut maybe follow waiting you on just are being are if together, maturing for data,

Joseph Turgeon

remember in so there because cut-off. studies. the in global have here a data to all world, do we data, yet data this, get data haven't whenever study you around you Yes, the other from and disclosed multiple a there was But cut-off past, the the the analyse was

though, as the a usually what is days update XXX certainly on in there. to standard, filing, the you data accumulated, there you have an provide definite submission, that's since that do that after that is that’s well. What and will cut-off we So, agency happens data happens and the

Maury Raycroft

mg last treatment you bar more the and can showed recently at you if just in that this you is? -- the then if setting? and HERX talk dose, the about from okay, comment XX just it, ESMO, success with question late q.d. And pre-specified a what on breaker what the data can patients just on is Got a me, on for there's endpoint naïve

Francois Lebel

Sure.

So, to and we trending it very I'm XX the is you the enrol. well in the originally FDA, original patients lower study right clearly are that, cohort was in as X going to pre-specified of the with know, XX, original submission and things bound at obviously -- or to because we agreement leave a on had continuing meet endpoint, and now,

So, with the we're that's enthusiastic we're and tracking presentation. well more quite why ESMO

Maury Raycroft

up we or you a follow on and guys...? some can are expect this at point Okay

Francois Lebel

definitely. yes Well,

but not given matures. it have want a some we sure, a data you data for release matures will as that once will it to little We yet, see just date of more,

Maury Raycroft

thanks okay, questions. for my Okay, taking

Francois Lebel

Sure.

Joseph Turgeon

Maury. Thanks,

Operator

Next question now line is the Ed White of your of Wainwright. Ed, line comes open. from H.C.

Joseph Turgeon

Ed. Hey,

Ed White

my for question. Thanks taking Joe. Hi,

have So couple I do of a them.

the be BID only the then the patients have these just you less XX Can b.i.d. ESMO. it dosing dosing XX? would out be will patients on, other First ones patients you at XX XX X, the mg are XX or be XX the remind the presented and to us, cohort going of and at

Francois Lebel

as bit some BID So, and data of first patients. the little we on you know safety, provided additional efficacy the a XX patients giving of we presented

for continuing we’re you agency, the decide with just once to registration. analysis have, some So, have much We right discussion we now, to need once and and how we guidance add the today. don’t give to much data enrol any and data go matures, do potentially additional we how we’ll

Ed White

a us we could another about haven’t FIT curious that like that data or also, product I on as that. the or sponsored the just patient the KRAS maybe non-Hodgkin’s then you is there? that? any company you platform thinking as look and you an refractory data are perhaps and Francois. Well, as if discussed pozi of maybe at you lymphoma, KRAS clinic IST, running was in something give really far can update pipeline, trial product the with population in there update any Okay, preclinical the talk go, And INGXXX in

Joseph Turgeon

Sure.

start So, FIT. with let me

So, study, it as we've part what a has happened do clearly you of of first in efficacy during slower have before, man COVID don't caught that clearly performed dose accrual. has is was study in the you indicated wanted. terms that, pandemic, when this worst negatively the into we And And data. than if impacted got escalation

do So sure going. currently review recruiting, we're assess the this following reviewing that asset, that to, want how asset what it's will a with open long and to making been want it's and we given and we we

early program. very update this. ROLONTIS, So priority you these than pozi, on the Clearly, we'll is stage rather

because is potent is, have question there's need KRAS, quite least it is data, our patient. And you mean, for encouraging, a advantage, combine rapid a first and but for you drug. but And the, relatively the KRAS So to shows which really, that's it that get an here, the really most and that true investigators this one is TKI grant which in data to the don't the in And but will outcome Amgen inhibitor, to of to you has combine best next is, you vitro, realize going we're just vitro there shows so they're have this I development nonetheless, companies pan-HER inhibitor, do is at one answer. to poziotinib. been one resistance. the of excited. The knowledge approved, that preclinical one really

very interested So we're further. clearly in this pursuing

ISS near sponsored study, decided we'll a not an it's at or have We the this future. if stage in to going but you company I'm with update be sure

Ed White

your I or maybe, cutting. a And responding approval? -- was you doing finally directionally Can great just pozi what cost also us can runway we you're on wondering, submitting you're to R&D, the seeing may with forward any question guidance the looking Kurt. to and give be Thanks. in and G&A Thanks. a be just job cash as to for CRL

Kurt Gustafson

securities. balance Sure, mean, obviously see marketable quarter where we of in a cash for so $XXX could and Ed. we This the million late late stage time cash XXXX, be kind which takes with I fund potentially these approvals Yes, to should through into ended operations sufficient us two assets.

mentioned guidance, we specific have Now, recent guidance, we the been in give manage on control terms I call, looking CRL. we of any the as and don't to expenses given

expenses lower And expenses so, SG&A a little quarter. you did G&A bit this or see be

continue we look we invest successful. want that, So obviously these will to make assets to to to do but go

the non-critical few going we look here to areas for we'll but to to poziotinib ROLONTIS, assets brands those put So, moving money are kind that into are continue to of next the cut and in forward quarters.

Ed White

Okay, Thanks, great. Kurt.

Kurt Gustafson

Sure.

Joseph Turgeon

Ed. Thanks,

Operator

Michael of the your Next Schmidt Michael, open. from of now question is line line comes Guggenheim.

Joseph Turgeon

Michael. Hey,

Unidentified Analyst

question. our Thanks taking is for Paul Michael. for Hey, this on

us patients, Thanks. hurdle I treated recent to one approval for submission, seen potentially previously we've given poziotinib on bar Just higher wanted non-small thoughts your on for confirm NDA cell the from like approvals, and [indiscernible]. the the

Joseph Turgeon

I for, Sure, mean, Cohort data. it's it's going X so we're

least So to it's of XX HERX and add mutation. patient XX it's for insertion exon line one treatment really exon pure at

looked, good of think potential exon mutation our the for looked is to at this have they we when number really true there given development. HERX, eyes, at, at XX going -- insertion that we And meet if And, the we're other we data point. you look their very market. in drug to But it they data approved to have here, we So a first timeline the think no there. drug in be there's

Unidentified Analyst

it. Got

Okay, thank you.

Joseph Turgeon

Sure.

Operator

Mayank from is B. line of question line Riley your of Next Securities. Mamtani now open. Mayank, comes the

Joseph Turgeon

Hey, Mayank.

Mayank Mamtani

taking Hey good afternoon. for and Thanks the on our progress. questions congrats also

high the longer the you obviously, and on your if at to the just Because latest NDA design? part what for patients had in cohort the for part you question just highest then need b.i.d. more level ask to X sample confirmatory of cohort you So it specific dose, treated, the registration rate committing Francois, was, I that as as approval? size, study I may across do thinking getting X? of of your followup path terms And is are filing,

Joseph Turgeon

good very two questions. Yes,

b.i.d. important the X. data discussion with allowed the the had we've on is in win cohort agency some data got we've some far, So from the an q.d. they that include to data of of so us b.i.d. top

as we b.i.d. really exact the can't how as you the it's going our answer if that I want data latest an about will the final goes it in. in thinking So on have to give b.i.d., you I interpret depend NDA FDA because to put think

we'll to to So well there patient some about in we maintained, how that b.i.d. activity that a feel side have favorable have seen, that as that as effect be certainly the they shown was q.d. good profile Clearly, to early Judge have we very data. was appeared the

So the We're to in see we discussion and NDA going during some there. have where I imagined to review, from there. that's going go we'll go

the your that's remind sorry, second question? question, me first can you of I So think,

Mayank Mamtani

the confirmatory to Yes, the study get approval. full

Joseph Turgeon

absolutely. Yes,

nature So agreement a you clearly want obviously, you regarding discussion to you I we sure the and are And, have to in to would so this. we're complete to we want do the have we of underway PMR, say file as agency the have that. make with But essentially the if absolutely when developed we NDA, intend PMR. in PMR. And

HERX are the strength it's not, the is study a drug so standard guidance to clinician groups, there further of as approved what prior approvals. takes same multiple go that, approved There care controlled they are any on but not from use patient. or those have called, don't for I'm various no because probably going the but that So a randomized

form it's you or minus will able to plus chemotherapy, now, with need be checkpoints. to agency And probably define soon and quite some I'm as doing. we're right some So know, you sure that we'll what of and the see

Mayank Mamtani

Understood. final trying kind where the just enrolling dose there [ph]? to on the remind Like, And how atinib X, of are my and question there cohort new what end we understand just are osimertinib failures. maybe with with us you market is, the

Joseph Turgeon

accruing. time you Yes, to of little a continuing are and of in they but date at of restriction focus, accrual, obviously NDA. not -- X yet. way But where on they're gets announce relapse, obviously, are genetic we're And, of of our bit certainly tumor will if continuing so, some focus, point need profiling I a cohort result for we that enroll. you quite is at focused There that's just certainly have don't the X the primary we the and want and we X. X cohort some the

Mayank Mamtani

much taking questions. so for Thanks our

Joseph Turgeon

Mayank. you, thank Sure,

Operator

Next question the of open. now line comes line Reni, of from your Securities. Benjamin Reni JMP is

Joseph Turgeon

Hi Reni.

Reni Benjamin

are I already. option phone this update you'll how and this b.i.d. Joe, my the the it, fact I to apologize, data. be data b.i.d. think obviously so and afternoon. the But NDA as that Good and you data, q.d. Hey, you? may submitting have answered I have with the the dropped, about guess,

treated many to could total related with know have label b.i.d.? includes feel to that we'd file do do up b.i.d. of you have you? you it You wind need what, of have the just how getting a iteration that a know, and to separate both? this Or we do patients been been SNDA you you that as do this that comes think likely that, in dosing, that sort NDA, when Or

Joseph Turgeon

me there. earlier, answer first a I clips now you question, did let [ph] the little So give but the it

as very the the that has is So, include data which the to we dosing. in know of agency us b.i.d., you pleased some NDA, q.d. had we were the allowed b.i.d.

a agency b.i.d. is increasing with that, get data. is we'll chance the So to body that the And time. obviously that discuss all data of

and non-small we cohort have cohorts have So and well. X b.i.d. cells, look as some X, if in X X dosing, at you we in we're

there so you all and were is, disclosed far, just have XX. in the not of patients. say when you we're we than b.i.d.. that more cohorts using let's of we So exact have that combine we patients have excess the XXX know And number where And

Reni Benjamin

for if thanks guess panel there twice. since question be might answer apologies again, the it, before do you Did Got have that. also for had answering And an I I think ODAC you answer you is, this it to other application?

Joseph Turgeon

I agency don't controversial now, it's, is, Right ODACs input the wants know. the think when for there are issue or don't I expert often oncology the Yes, from to that get community.

no to there's no is our far, controversy So there knowledge, here. it's major

and idiosyncratic safety met much have other that primary as no agreed the is ago, We There's reactions. in really with predictable, with very profile endpoint that have kind time we believe we agency a the some of line TKI.

FDA indication So any right don't we now -- what we necessary. can't eventually, we have will to predict the obviously, that will no do have that want we but be any

Reni Benjamin

be remaining their they'll take they for was just decision? And and And there both color? they of a show what you the of or them job really it, how seemed think, I item hope a dialogue. know, to and flowing own given word remediated. can Or and and know, at FDA, you gears a a documentation just, boxes to were that Joe then bit us mean a maybe check, just least it end ROLONTIS, just lot of come But whether addressing free you last go that it, it small care completed will of the like more when be I in you were Could your I was sense and re-inspect just Hanmi, you switching needed with quicker would were had in able guys have give did gating you corrected? it's Got by the in your lot ultimately thought. us to give year, it we little said taken this at that pretty great deficiencies everything a which facilities, to than these you the kind with of quickly like just meeting

Joseph Turgeon

is you started went we was back easy. is What you a and had okay, as to in, CRL A you need Class sure what we we said, we went that we remediation, because it on remediate? happened Hanmi once what the that it exactly get, August, in, No, they in immediately to it to is, meeting, work clarified, wanted go make is. it you We immediately wish I tell

was immediately be file we out, that. got so, that. you going we That's end There the one item after could year. the we as confident gating And that, pointed pretty say done by to we shortly it's of feel why

caps they still Now you have campus what through the campus, to all still have all decision inspection place, those remediations and put -- the They we of inspect will through we've part remediation so all still done the where someone the in play, the come is part final the and plan. be the in do to that go but, put have if end. into of and what go they'll in

Reni Benjamin

Got it, questions. great. taking Thanks for the

Joseph Turgeon

you, Thank Reni.

Operator

back to further turn it no now I this Turgeon. at Joe time. are would There questions

Joseph Turgeon

Thank you, Operator.

Spectrum. like listening all you for all I to participation appreciate of on really your call on First call today. in I'd interest your are of and the thank who all the

Investor in Just Hematology know this to which later early we'll and be participating Oncology virtually Summit, also is December. JMP and Jefferies at month let you the the Healthcare in Conference

future. talking not forward have in and at many also to those thank So distant you too interest for we look to you, your everybody, Operator. the you a events evening. great Again, Thank of

Operator

to and presenters for This who much call. participated. so concludes you thank And conference today's everyone welcome. very You're

disconnect. day. Have You a great may now

Spectrum Pharmaceuticals (SPPI) 11 Nov 212021 Q3 Earnings call transcript