SPPI - Earnings call transcript Q1 2021 | Spectrum Pharmaceuticals, Inc.

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Operator

Good afternoon, ladies and gentlemen and welcome to the Spectrum Pharmaceuticals’ First Quarter 2021 Earnings Conference Call. [Operator Instructions] I would now like to turn the conference over to your host, Mr. Kurt Gustafson, Chief Financial Officer.

Kurt Gustafson

Thank you, operator and good afternoon to everyone. Thank you for joining us today for Spectrum Pharmaceuticals’ first quarter 2021 financial results conference call.

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

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

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

Joe Turgeon

thank of Kurt. XXXX beyond. groundwork for will you, us believed that and a laid the you XXXX, in afternoon Good in I joining us the achieve to allow important call. In milestones Thank number today we and

to Cohort HERX had with the of fourth for is lung the application poziotinib. NDA on cancer NDA this patients. primary pre-specified are poziotinib a to we the new of planning endpoint strategy and During with previously exon non-small-cell quarter proceeding our later the submit work with ZENITHXX met submission these submission of insertion positive XX treated it the we mutations That underway cohort of discussions are agreement and agency, and an we evaluated year. Based based from a drug well for the the FDA for in data with call X XXXX, with study. review patients the the the The filing on

presented which designation, AACR the the TAT in is drug early poziotinib Meeting Track with of Fast this patients granted FDA data the the for Meeting and importance We of at an addition, at Annual In additional disease. for indicator March terrible in April. ESMO this

was dosing for aspiration across We this NDA has data indications. be a from significant The a an believe advance promise. efforts. and twice-daily in in can the which we product the development as beyond therapy important filing. improvement extends for both in realizing step initial be targeted will our Our multiple The and this TAT the tolerability, important efficacy well pozi program oncology demonstrated recent AACR ESMO

scheduled Now, the our believe this step for inspection. inspection Hanmi’s regarding the world We marks manufacturing later final facility ROLONTIS, the FDA is approval process this and of this that the pre-approval class facility in month. ready inspection for

catalysts two on on Dr. in filing. with months, Dr. lead making Francois? would our our the real to We Lebel, programs over that, with progress. an for progress NDA a CMO, including coming development are like expected And major turn our clinical it to launch an clinical Francois update I and

Francois Lebel

to submission based glad This of as And X under I with mentioned, for will NDA year. data achieved will Preparation poziotinib. the you submission this of Joe be milestone am everyone. be Good trial. the well way. the Cohort our Fast ZENITHXX with a I afternoon, will later is designation under be from important positive today. Track our begin on clinical

of believe cancer great approved and HERX for we medical in is As this you pozi non-small-cell lung XX potential with may exon to know, to need. be insertion address to the has there mutations first treatment market no patients area

EGFR with only cancer of the activity activating reported further or mutation for non-small-cell with These ZENITHXX of and includes results real meetings. was trial BID around also HERX AACR EGFR with Cohort previously and our a may safety lung improved recently at profile enhanced not The hypothesis treated provide solid meaningfully data for tumors make mutations mutation. medical patients a anti-tumor eventually two difference, and support observed and dosing. HERX, other Additionally, presented from exon X at XX insertion but

arms events or dose. either For patients as Dosing improved milligram in Cohort X an XX per meaningful not milligram day and also but with who reduced clinically as effective a patient was XX.X% XX milligram rate interruptions. the a the demonstrated received reaching improved The related were a dosing. of X twice by BID with pozi were in of response. observed improvement arm, day XX adverse dose were once partial BID randomized approximately the X, to or Other BID activity, XX% reductions X day tolerability allowed higher X A milligram BID and observed. Grade for in also response at

X. exclusively the dosing that enrollment We Cohort patients and X milligram this at are accelerate now in BID change will dose expect

enroll X clinical in At upcoming on with had who CNS patients X non-small-cell to data is mutation baseline early Annual BID treatment. trial XX milligram ASCO ZENITHXX in well Meeting our we patients Cohorts X. exon X June, Now, presenting the line be receiving Cohort to continuing metastases of HERX the at in first with will

anti-tumor body continues the progress. we supporting pozi evidence get As you the as of to and can activity see, stronger of safety

Now, let to me ROLONTIS. shift

pre-approval already our in this result has for on status inspection. updated positive a and inspection our side, Hanmi, confident with the Joe preparation the should FDA plant of regulatory outcome remain the we partner, On that you

study ROLONTIS Generally, chemotherapy. it given the clinical patients. an the program, achieved the on As market the dosing on be white must chemotherapy as now create significant after this difficulties to study exploratory with for dosing is of and XX development same ROLONTIS ongoing enrollment the has factor cell growth day logistical patients. day can relates same-day evaluating our This full

plan the later at this XX upcoming present examining our evaluation post-chemotherapy, arm cohort XX We to enrollment scientific dosing hours results XX-minute Following X meeting X patients. hours, from the year. we minutes, at the an and initial safety the expanded in to dosing

to year property, on part from is the turn with indication rich us to in giving this BLA, provide progress you a over to of the it in While and different the for it and feel compound is our the our evidence now review updates balance data current further plan regulatory is biosimilars months. the We of will milestone additional key differentiate not ROLONTIS further a financials. pharmacodynamic The with innovator. this readouts. of coming Kurt potential being novel of the of I

Kurt Gustafson

Thank you, Francois.

to quarter primarily program. associated in was million expense expense SG&A program with first million of Our XXXX previous the $XX.X increased year. costs $XX.X poziotinib the R&D versus versus $XX due $XX.X for million was million

quarter non-GAAP which loss net quarter costs $XX.X primarily compensation the was $XX operations marketable out the stock year from our Our XXXX. in from million prior XXXX. backs in was basis, the loss million We the the December in of for change at securities value $XXX $XXX $XX.X the our securities, million compared continuing down $XX.X approximately period and for million first ended cash period. with in On a to plus XX, quarter of comparable versus million, CASI million

Joe. included we is where the issued first for been quarters. million. $XX in With an ATM the with cash issued proceeds program. $XXX the end of These These in balance cash of be included agreement our are consistent cash and the quarter. launch additional XX burn of million that, furthering in me we to over This the equity March our planned used XX the utilizing After call first in quarter, agreement. proceeds development our have March poziotinib Operating equity, hand from proceeds $XX.X ATM the balance. million was not million last Our will ROLONTIS for the net of quarter off $XX.X let back few

Joe Turgeon

continues make facility, shortly. our you, development of of ROLONTIS strong and Kurt Francois. We Dr. is which inspection and to Thank pipeline. forward on steady to planned to our the manufacturing the Spectrum you, thank look begin completion progress

could open We like preparing with please actively line results our this And Operator, questions. for you questions? clinical the share trial additional poziotinib call are would from later cohorts the I year. and that, for plan up ongoing the to open ZENITHXX to in our for NDA

Operator

[Operator question sir. Yes, Jefferies. Raycroft from Maury Your first is Instructions] from

open. is line Your

Maury Raycroft

the Hi, everyone. Contracts on progress.

Joe Turgeon

Hi, Maury.

Maury Raycroft

Hi, thanks the progress Joe. my taking for questions. and Congrats on

ask and little that you specific exclusively X, mention? the that was factors can And switch on filing or in with perspective was bit are will based what for So to on just talks gating provide your FDA I with a regulators conversations Cohort you X that? about mg BID can more

Joe Turgeon

Francois, about that? Yes. you don’t why talk

Francois Lebel

Sure.

so was at was done So, to – we milligram where successful XX XX pre-specified day. remember endpoint met first, Cohort a the milligram once the done X Cohort with you X got

discussion the profile and upon base the filing. with do. is around the with met was yes, manageable acceptable, to FDA So can discussion safety you that’s had of they what us and this. – file that’s we we believe said, the basically the that The We

we exactly doing. that’s so are what And

Now, since profile, actually only then, we we’ve X, and in actually can improve we we we Cohort on that but have BID and as have saw efficacy maintained adverse the built by type it’s dosing, of clear not it, the event performance mentioned.

that positive of the X. be hope information type answers with will that you. this is But with I filing answers So Cohort primary the shared agency. the

Maury Raycroft

in That follow-ups. And queue back helps. the I’ll you. with Yes. hop Thank

Joe Turgeon

Maury. Thanks,

Operator

question is Your Alethia Fitzgerald. Cantor from next Young from

open. line is Your

Joe Turgeon

Alethia. Hey,

Unidentified Analyst

one. just have taking [indiscernible] Alethia. This question. I thanks for is Hi, my for quick on a

dose and you talk are dosing you Thanks. about With both the presentation can frequency? at about how thinking AACR,

Francois Lebel

Well, was about pre-specified It is essentially Cohort it to the positive. think may that Sure. we that a the way have X have endpoint.

FDA, you medical allows and – fact past, not at have to need I’ve with very us only – Track So, data to now have higher also basically of the submission. a also so designation have X we in establishing NDA in allows only the important the for that previous AACR, able Fast but AE. performance that of shared important improved data we’ve an seen result just and very have related what efficacy that’s reducing actually that’s disease rolling because the we terms call or be of the that’s we to patients, would and but as the is has it to as we not XX% the nature were we shared mentioned very, that added also what’s as maintained the have secure us the we as Grade drug that well the file

better we getting like is as this – add are patients. those So,

that it. So, we successful improving now on we and was cohort a are have

and forward. So, excited about why go pretty we we this that’s are filing as

Unidentified Analyst

you. Thank Okay.

Operator

Your Ed Wainwright. from next H.C. from White question is

Your line open. is

Joe Turgeon

Ed. Hey,

Ed White

for Thanks Hi, Joe. my taking question.

Will to looking my So, you you in want multiple enough EGFR in at And you are again to indications. mentioned filing that just exon have study will if or to of mutations. indication cancer? XX another indications reconsider or for be of I know circling other out to developing the back X perhaps data this Cohort of pozi are you outside is you question – other pursue coming lung non-small-cell thinking

Francois Lebel

Sure, Ed.

you I So, for yes, premature be communication. me ago AACR the a about the will be review be think just it’s but body There NDA at ESMO the obviously, of here already of TAT will answer kind to shown there that how have through data are a FDA communication going will shared as and to we our with continued the is we the as have to that in at data, – agency. minute indicated little evidence and

of the predict But is were that weren’t majority to you showed we can’t exon remind the patients. going data it. I HERX. to you so AACR, They in can BID how or the actually at XX EGFR I milligrams react they the X And tell patient are what

and the data. best – where saw So we that’s

very will activity. We be CNS about also some I at data interesting showing think ASCO

think have or want what the what And we case are better just if it’s top done so to we in X, getting the you do. which given what needed we on Cohort just seeing we of – met here,

with have also certainly will discussion the shown FDA, covers activity but we not So, HERX, preliminary but strictly we to have the additional now the EGFR. expansion to seeing that is we are have in also

Ed White

the the FDA Hanmi new may, once we the get I issue pre-approval question quick what thinking inspection on are steps? done timing? Thank Thanks, a if date And will about be next plant, or just And on the ROLONTIS, Okay. PDUFA Francois. you. how a should you

Joe Turgeon

exact were we date the PDUFA well know the back go clearly know our where time, in – know, a I back Yes, let’s as October, not you CRL, in and don’t in but know there we the recall which if problems like know received all have people back you we deferral of our CRL, file. we clinical many we do other we because I you companies And of got South didn’t. data, the we would gotten to the to with But that. couldn’t feel Korea pandemic, timing, get

We’re inspection. prepared the for

can’t of to the I us we date, a done you an is the We’re the exact get amount feel once looking would but give and reasonable step. I take to FDA think forward inspection it. to back that’s last time

So hope that I be it’ll without time, the amount answers I question. is exact of a done. after the think time giving reasonable inspection your

Ed White

get you. Okay, I’ll Joe. back. Thank

Operator

Your from Ren next Benjamin question, we Securities. JMP have

line is Your open.

Ren Benjamin

Hey, Thanks good taking guys. my afternoon, questions. for

Joe Turgeon

Ren. Hi,

Ren Benjamin

see start can X now might well is just of from timing then patients your there? Cohort dose? just off, Cohort enrolling more continues mentioned are an to data on cohort How for enrollment enrollment think we’re X as or beyond? X I with and many X. maybe And everything into how And when update dealing cohorts? give focused guys sort and X the Joe BID we us we mgs update planning well those on sort that in X, you of and you prepared remarks a

Francois Lebel

Sure.

So, Cohort as we communicated what dosing we to with roughly have XX the recall and discussed was will in mid-XXs we were FDA X, that, target when enrollment our BID is that patients. switched you the

showed of and Stage X And have arm presentation we X enroll the design continuing at the want, doing. a enroll number that’s BID you XX completely per and that’s to study today. – randomizing result Cohort a X to of arms. had continue the and to patients to it’s we we’re arm we were X, be which stage if to switched design as we had AACR, that’s And now BID because Cohort did. we So expand and itself completed X best patients we and of to the why the two-stage a

indicated going have milligram in patient, no enrollment number exact the we we’re think that other in or well the going to patients let it’s all working us patient just the number the of – because X don’t longer are I we’re of and So, arms, assigning very say but now BID.

the think faster. now that we So, to happen going it’s enrollment

So that’s next and more as to today tell stay you going information. couple probably we’re can tuned as much advance, I as than other of months have the

relatively to you represent X, mutation, want. X if these As and cohorts rare very

it’s in satisfied, but positive this activity X Cohort is any cohort now expect exploratory. that we’re really So, we enrollment and Clearly, X. and It’s ongoing is forward. We near-term was cohorts the and the important there. don’t as regulatory go X

So hope that answered your question.

Ren Benjamin

question for that. just like though seems It when going it off Cohort you doesn’t, I a regarding let’s in is Francois. Ed’s X, I’m but don’t you the the with X you even Thanks and might guess to opportunity. Am just of say, little And actual being bit have, expansion potentially exuberant stop, regulatory maybe data enthusiastic, that possibility. could really agency number go a it a as and too being potential to about seems an like discuss or that Cohort I

Francois Lebel

X, only into Yes, on pretty look, as Cohort on is but not we’re think actually, and we’re – X there well. excited we discussion Cohort

for we be have we and it is winning EGFR NDA see exciting again. and Cohort even now data and X, what the data as Cohort data have filing, we where FDA the such, they only seeing believe goes given where disclosed also about also basically to that But as see X – Cohort it the we the will will we’re X, not includes but more to the will prepare we We go. as

seen So clinical we’ve always activity.

and the amount. If their had you had huge activity. always recall cohorts, not Cohorts by across endpoint, primary but all clinical we X missed X

in get dosing, see different with that So might you and cohorts you a think different X if very now given redo outcome. what X X, Cohort to we we were

encouraged. very So that’s why we’re

Ren Benjamin

my for questions, thanks taking guys. Great,

Francois Lebel

Sure.

Joe Turgeon

Thanks, Ren.

Operator

question Securities. next from Michael from Schmidt Guggenheim is Your

is Your open. line

Charles Zhu

data, progress for questions. day this Hey, Charles initial the providers guys, label this formal it a either get steps same you Michael you one on schedule and enabling I Schmidt. after or understand for Congrats once convenient on more had on this is incorporating Thanks. Zhu this the But us could to thanks dosing. approved. label change. ROLONTIS you utilize will formally arise somehow the into the potential data before and help timelines taking or get hopefully BLA fully the to potentially Presumably the

Francois Lebel

Yes.

the the believe question and queries, even the current discussion, all – FDA. the we discussed has the we’ve BLA, So been the Charles, label answered have with

the is only we item outstanding think So PAI this inspection.

any that to So dosing and label the announced think we the We we’re discuss be the today here enroll. there correct. going an to we would that would same-day language near-term, approval approval and result don’t expect remember, about you’re you although and in agency don’t – fully not the to think after the still be with got dosing have that analyze of what we in same-day I there hopefully that in very hopeful We advance data. is

the And meeting approval to positive in we have is data comes, seek scientific discuss if additional the a agree we plan data the analysis present we so with potentially the on FDA as will on some and registration data that near-term, and obviously. the assuming

Joe Turgeon

Hey, add We launch. on. all not we along, we spot label just we’re that Charles, could going this knew have too, if was on Francois I – to

the wasn’t more the compete would We’re the convenient and that’s it to fully label. be the been this injections, who for by etcetera. and it road nurses to – is if this would tried be the as and give This in as Francois say, for was other prepared We added label the down patients, accomplished is. Dr. doctors something the past products certainly with actually

the what to the it next I prepared be want without and launch differentiation, be not moving all was news to that’s along. this is fully This plan was of but we’re step, point So expected. a to forward that clear, would we’re just good but

Charles Zhu

you. Thank it. Got

Joe Turgeon

you, Thank Charles.

Operator

B. from Mamtani Mayank have we Riley. question, Next

open. is line Your

Mayank Mamtani

to questions congrats on taking Hi, the and Thanks afternoon. for good progress. you our

I of So landscape competitor two have questions. sort

the have that maybe in helpful? have any EGFR, might would be trials, that with first. benefiting a there question. as on developments on So these HERX Could I starting pozi been from touch also then you also you and separately both think if And enrollment about you the be ROLONTIS

Joe Turgeon

Yes, I’ll...

Francois Lebel

Yes.

Joe Turgeon

Francois, about competitive Yes, go the landscape talk ahead, why don’t you first.

Francois Lebel

all, on HERX. in Cohort X first was so of – the Yes, the

So let’s there. start

order few they we was to Daiichi, here, – the bench months try of explorative, case on speak I to they and have to, obviously, bit. behalf with the ago different if I lower been dose a drug in announced HERX, that for the It’s have but the drug. So our with developers don’t we dose not back are reduce now to and Pneumonitis of issue assume, think they could closest had drug other looking at an a that particular the are a going see want pneumonitis. rate

We pneumonitis than to seen were the in their rate with X% drug. of have they X% mid-teens

So that’s HERX. the for one

bi-specific announced EGFR filing. the is On have J&J there they are and front, that

So than be – will market, obviously to sooner us, evolve. how that could could we certainly they but things get see

just I’ve encouraging. certainly recent very mentioned, As is our data more

too it’s tell. of to early kind So,

Mayank Mamtani

get color further your branded biologic? you certain think obviously move then and top a novel of the on of Great. other neutropenia management Any GCSF day that for is the being good, there ROLONTIS, you on don’t about to but lifecycle also Thanks – alternative And are as for on sort taking sort are classes needle same thinking, again with tested that. as this monotherapies. you on of benefits as drug know,

Joe Turgeon

I’ll Mayank. start, Sure.

GCSF, the BTD one on GCSF. that, look in products really could at only be drug for so another that’s the you look along combination of spring at been of you done, to granted really who to patient pay what Because with it’s all, adding when with myelosuppressive who My the there that’s pretty product, for this good the First patients be two agents GCSF on? taking are are working population in would is who today. payor darn get need patients now for its drugs works question a for when

product – different a that will that. is stages. early So early It that’s on. be is there is another approach, There that’s but sure,

patients its GCSF benefit see that I think, be it, own with that. that and is way types from very now, the be beyond combination could the unmet right but there’ll don’t need well go patient most and with do but on a very, may I GCSF maybe it to there So certain

Mayank Mamtani

it available of the final actually some of stockpile about sort like patients Got Like, was, is meeting month it, sort X question other how give Could there? it could of? have And color you that can of of product it. worth just be a looks can of side what think ROLONTIS stockpiled. definitely month is for understand a and like, we soon worth this ton a we as the you May or on

Joe Turgeon

Tom, comment you Sure. why don’t that? on

Thomas Riga

Sure.

the hoping already instantaneously approved We hired. are and demand for ROLONTIS team generation begin will of almost the potential getting has leadership still as been

customer-facing supply majority to that get make of we expectation the will we have happens will and we ample of if sure on We plenty plenty plus have when And product, drug want what about have believe uptake getting be question commercial and year think of of you in have the vast first representatives the to based approval we stateside kind hired. of to that channel, covered. our your the we directly, supply

think of I biologic, the you materials, promotional expect final printing of can syringes. packaging with a of approval labeling, customary

X period. way to about in time is that to the I think week think X the

would guess and instantaneously would approval. the the selling begin drug contract actual between begin it, our would channel of strategy, post and post the I commercial X demand So approval, infrastructure would months but payer efforts rollout, X generation, all we hit

Mayank Mamtani

Great. question. you. much Exciting for my Thanks for months few taking ahead so

Joe Turgeon

Yes. Thank you.

Operator

from And Securities. Ren we follow-up from Benjamin JMP have a

Your line is open.

Joe Turgeon

Ren. Hey,

Ren Benjamin

still ramping must modeling off the Hey, Thanks in thinking force have that sales on follow-up. I the guys. up the of like. goofed the I my because taking this and quarter, SG&A on you’re was for

the closer not, if into, the thinking hired lot I it fourth thoughts current third quarter or sales do I’d quarter? SG&A force to to and we been a guessing, the those expect going like to some go how be still level, sales we materially just get so, and guess, I’m maybe about or have to And as should it of involved up with

Joe Turgeon

Kurt.

answer to want You that?

Kurt Gustafson

Yes.

The Ren. quarters. has million million, hey, So, $XX $XX the few run $XX kind for – million around been of SG&A last running that rate

I we to talked sort and identified they organization but think have come plan of in not the to of board. half got we people some as on that hire, calls, on board about indicated previous we’ve offers yet. we’ve about commercial Tom provide the

think, be So a ask that’s in it a yet we’ve launch goes as so marketing adding not or isn’t – said why I XX, that the only entire coming cost spend about, commercial about there will that you XX happen gain we I folks, are additional will here but we’re that whether we’re activities guess. talking talking incremental materials an and that. some about so clarity When organization will the it’s we additional weeks, prepared and up there for materially, giant right, various

SG&A will I go the notice expect increase we it but So, of as an you Material you hire launch do and material, in product. number not sort those up. – is define what to sure a folks once – how

Ren Benjamin

Yes, yes it? had color. I they additional know approval come you. slowly a I I to on bringing from that just know appreciate those – you calls once the bolus people are half, as didn’t board, think, if previous Thank going I know in confirms didn’t if – you’re takes so I

Kurt Gustafson

Sure.

Thomas Riga

post-PAI. add you I’d thing there we increase gated reason that that the that as number of haven’t the customer-facing seen is Just deliberately representatives only

want the derisk enough train having that to make hire, had and time closer too you wanted the path visibility approval, to time as we much think of sure and we execute, to clear get to prior approval. to program but I So, didn’t

So that’s the reason.

Ren Benjamin

I appreciate it guys. Thanks.

Joe Turgeon

you. Thank

Operator

the showing Turgeon, Officer. questions back Mr. I Joe conference no I this time. turn to like now at further Executive would am Chief to

Joe Turgeon

appreciate really I Pharmaceuticals. on operator. appreciate you thank I want the really we participation like soon. great operator. it. talk And I’d will thank to to and today. everybody you, everybody for wish their Spectrum I’d a interest for it. evening Thank their in like everybody you I Thank to to call

Operator

today’s this presenters. call. for Welcome and much. wonderful you very conference you gentlemen, and participation Thank day. concludes have Thank your a Ladies

You may disconnect. all

Spectrum Pharmaceuticals (SPPI) 14 May 212021 Q1 Earnings call transcript