Spectrum Pharmaceuticals (SPPI) 4 Nov 202020 Q3 Earnings call transcript

Company Profile

Participants

Kurt Gustafson	Chief Financial Officer
Joe Turgeon	President and Chief Executive Officer
François Lebel	Chief Medical Officer
Tom Riga	Chief Operating Officer
Maury Raycroft	Jefferies
Charles Zhu	Guggenheim Securities
Alethia Young	Cantor
Ed White	H.C. Wainwright
Reni Benjamin	JMP Securities
Mayank Mamtani	B. Riley

Call transcript

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Operator

Good afternoon ladies and gentlemen and welcome to the Spectrum Pharmaceuticals Third Quarter 2020 Earnings 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] And as a reminder, this conference call maybe recorded. I would now like to turn the conference over to your host today Mr. Officer. Financial Chief Gustafson, Kurt Sir, the is yours. floor

Kurt Gustafson

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

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

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

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

Joe Turgeon

and Thank the call. joining thank you, afternoon Kurt. us Good everyone for you today on

that's to our always really over industry. And course challenges achieve the continued progress the interest across year. appreciate Spectrum in your that spectrum. this to As impact has I and it's despite the the I'm pleased the with of had pandemic entire

the finish resilience, immune demonstrated the and to While company pandemic, position to XXXX. Spectrum our dedication, of strong impact a in for has isn't focus the staff

results we We’ll meeting outcome exon-XX a that the a earlier mutations. up in inability strategy program, results met end quarter year. demonstrated poziotinib that deferral including known the milestones reason poziotinib top cell This dosing key the complete to lung poziotinib. that We'll on that endpoint of The the of based HERX to inspect the COVID-XX week, as Hanmi prior related non-small ROLONTIS. positive otherwise was line update agency's remains pandemic. for in travel on patients confirmed the the to and active. the to review filing an The response for number a FDA and with we for CRL. for due Cohort the be Last of to FDA letter, Spectrum data pre-specified with months. coming X and positive next on These a This is in devastating announced from cancer FDA Korea providing with couple a BLA insertion not the strategy was have the deferring We action in was primary the also disease. the Bioplant for the file means South restrictions the overall announced significant this is our patients this be

the all inquiries aware answered not any the we're and outstanding FDA, have We items than other from the inspection. of

from the our will and feedback activities action FDA. certain further financial We gated resources pending with or be have prudent

development treatments programs of player ROLONTIS as great ROLONTIS accommodative behind tandem corporate Spectrum be for approval regulatory Korea, progress. it the for partner needed company world-class bringing Samsung. with the it. and as for aspiration global well-established in They've working in is our facility. which and to confident our meet possible. CMO Dr. to prepared Regarding to an only manufacturing as I'm over our of in turn Pharmaceuticals new inspection, the François? François call obtain to real that, patients obligations. the objectives the Dr. our inspection ability With They're is willing of it pharmaceutical cancer, clinical going partner to soon in second FDA biopharmaceutical to Lebel, to an with plant a largest with to a strives now needs who is the meet are the update the Hanmi been advance I'm Hanmi the a on

François Lebel

Good good for today to a you It's with short afternoon, everyone. be update.

previously for these clinical the and We discussion the with Cohort to the have positive FDA the forward in look discussed of very remain outcome excited We X pre-NDA trial. by near-term. ZENITHXX results our

patients receive we the is a Patients of one remind safety therapeutic The profile XX%. gap believe generation to insertion Progression control milligram X.X receive with free was there fill exon-XX in-line interval. median of lower a with potential great area as treatment months, an medical observed disease HERX X.X XX data seen enrolled The a of objective cancer, an with Most with demonstrated pretreated, an lung in others to At response was XX.X%. analysis second pozi need. year. in tyrosine of treat endpoint Cohort of kinase cell ZENITHXX immunotherapy. you of confidence X.X. the including defined was lower The drug in off, bound bound approved exceeded The follow were events ORR the mutation daily. RECIST with rate me non-small that intent continued patients cut seven of adverse heavily XX% pre-specified by with survival primary of and the patients months, once has X.X after for poziotinib were the Let responses to X the XX% important and median no and inhibitors. chemotherapy months type of rate durable with XX.X% a up

the or medical and positive result This for ESMO the We – Virtual Cohort their first also was the presentation large the the this trial. to in medical for community scientific registrational Congress Medical XXXX. European of and September results of presented the for at Society X Oncology at

the We which are has with preparing meeting pozi, been the for for FDA already scheduled. pre-NDA

cancer non-small HERX the for with the or initially lung with previously indication insertion of advanced discuss to cell treatment mutation. will registration We forward locally seeking path an patients exon-XX treated metastatic

dosing BID. Cohort in reported, been X X Cohort X well fully have end you in for X We underway received actively XX and non-small define our the to trial. update single milligrams the dose. before dose. over still enrolled XXX and lung that in in to with X effect and now and X are patients insertion plan mutation milligrams year Cohort to EGFR The first-line exon-XX first-line a cohorts a minimal HERX poziotinib of enrolling data daily Additional of the cell cancer enrolling this the date us strategy on Cohort is both Results pivotal further further patients at successfully provides exploratory is

arm [enhanced] X safety profile, the reviews sub-optimal it to arms. and enrollment stopped benefit recently day the as anti-tumor BID have X demonstrated safety We early in XX-milligram during and An milligram enrollment this indirect our milligram but dosing is activity. accelerate in action dosing per of

We providing data a scientific will be additional in future meeting.

Now let shift me ROLONTIS. to

analysis Phase the this Meeting clinical demonstrating two presenting to Antonio place for Cancer prior be and meeting, by two all ROLONTIS available to shows ROLONTIS large trials. to randomized coming and robust I endpoint for the Virtual poster X supported was profile pool Breast the will X package. pegfilgrastim. strength a of trials The that clinical the clinical BLA safety secondary here duration should of at is the data of San primary and be The met will poster of December in viewing neutropenia the endpoints. met similar XX. non-inferiority taking from Our severe our we mention

As day continues. an the a of that reminder, same as is ROLONTIS This our exploratory enrollment in evaluates the same study day dosing study on dosing chemotherapy.

we determine move whether end have by of that We the to the expect phase expansion will year data study. to of this an

have all review ROLONTIS to As on questions BLA, of answered had to the labeling we FDA, advanced deferred action, related and discussion. the from filing, our we've the the

during and on program our to including exploring forward over possibly now it some we of with registration FDA. in I using ensure ways into of to to the our next have of outcome Kurt mock milestone COVID-XX this We the pandemic. will insight methods you the plant the review turn third manufacturing earliest the poziotinib alternative the are quarter two inspection, expedite multiple financials. On our side, discussion of completion months, to look inspections for conducted the our important updating BLA

Kurt Gustafson

François. you, Thank

third period the require no goods. $X FDA a in million quarter The zero to expense previous the when million to in accounting inventory of quarter be it Other XX.X the will was compared year of primarily the loss in The value we to million, until in for in sell equity income expense last that increase inventory, a purchases facility this to ROLONTIS the a R&D is compared of but an in ago. we as of the third XX.X as cost the in million quarter, XX.X CASI. X market product position SG&A R&D a versus expense readiness us a income the this a drug million to substance million. loss for for at relates inspection. primarily Recall was manufacturing expense million Our XX.X third third is expense rules R&D related versus year. approved, of purchase was expense year XXXX the state our quarter decline of of X.X in kept of the

late we've consistent net burn, We versus million last This million flow costs, With ended Our back of in raised million cash of was CASI best let hand reflects cash in ongoing we which financing now a the of you quarter the proceeds On financially in primarily million. commercialization with our late XXXX. continue quarter and Joe. where is in assets. is the for plus our the in out to XXX.X from quarters. change in year quarter as that with me plenty loss XX.X the cash stock are measure can the XX the non-GAAP XX.X the the of over the for quarter. XX to call with comparable The a for third July compensation our versus our marketable the see, period net XX backs stage prior million few period. XX.X basis, million runway positioned Operating million our cash balance securities. well development loss was been was And value the in securities, which that,

Joe Turgeon

you Thank and thank you, Dr. Kurt François.

of we see and inspection our In completion pipeline. weeks, I to on coming continues the to that steady the all facilitate doing strong think you make the progress be we'll can the our everyone's in remarks our spectrum sharing can pozi, of to is clinical ongoing We trial. facility. cohorts on additional forward pathway registrational look FDA updating later this our results the you ZENITHXX discussions for manufacturing on the ROLONTIS and for year from

participating future Let thank entire our that several team time. me healthcare connect we conferences and Once our for on their work, unprecedented times. I'd if at And appreciate it. will these with like up progress. their you hope for many forward to please. upcoming in keeping remind informed to you the to dedication that in the look of be call, questions. I'd you investor again, hard open up open call to with We Operator, that, you I'd like could

Operator

you. from Your the Thank from line Instructions] Awesome. question first comes Jefferies. of Maury Raycroft [Operator

open. Your line is

Maury Raycroft

everyone. Joe. Hi, Hey,

Joe Turgeon

Maury. Hey,

Maury Raycroft

Hi. question. Thanks for taking my

on is ROLONTIS. question first So,

label if help mentioned FDA discussions, that. asked potential guess the I elaborate then a I'm something mock that's And along. is to FDA François that wondering could inspections, process if do So, inspection? for considering just virtual mentioned you can move you the wondering And on and how and

Joe Turgeon

jump in why take I’ll really François after. Yeah, three in questions you is There and there. don’t

Let’s you asked. François any comments there? label start the question with

François Lebel

Right. Sure.

FDA the inspection right, right we all To and And they drug. outstanding this knowledge, now, indicated the questions, to knowledge, until, course, of of have know, main my this the our thing that them. of review the manufacturing we've Joe's, file we've we of know believe you remark, that was in answered But as our – So, satisfied. a during many that manufacturing, our approved received the is don't only plant. we look

they was, the inspection? has GMP think guidance a interactive in today I developing I that actually of form process video, earlier issued actually, reading the the would statement yesterday, alternative that was consider they're different evaluation. for second of So, FDA component just a

to. open thing that's certainly that one we be So would

were drugs. that in not plant using conducting but are that the have process considering of other they had know, yet. the guidance that, agencies for yesterday them guidance developing as priority drugs And European to talked for issued now, specifically like that. you We the they about may news is that FDA are technology of inspection

your question. So, we that. third remember look hearing more from And the can't of I to component forward

Joe Turgeon

has of conduct Yeah, I'll a different plant mind, said agency ways. add he an understand one take to to Korean the that inspected this Dr. time, keep in variety François. inspection it's I'll for example, has that, know, to thing what said François authority. on certainly important in authority just this like And, been that by what the to to the you

help, news is everything inspection. want they're absolutely something that's you this unprecedented maybe to kind and try we So, can, that we going another have because for that don't line of I we they bottom times, in way change to the But can ready we're stress know. looking thing, to do it's good are to. And business,

but We third question with sure fact, the was are world-class the required make Matter welcome have you, a we I Hanmi, manufacturer in the which ground there, closely it. They're an they these tell have people Spectrum is inspection. stool, And looking we plant. we've of required? it can ready. what and I FDA of boots ready outside for to know inspections. a inspections, not these, these And people we your inspections, Their have on world-class we're mock we a And that very run leg exactly a mentioned, have these are long the for with this part mock do by them is the have mock we do hired we experts, was certainly agency. We time, the not for help living. ready, only done to run who third – work They readiness. a also the this are to with

know, So, inspection already, feel We we can't ready. welcome the wait. we're you we

Maury Raycroft

in analysis case will all that get meeting, from if be second to X Cohorts? and insight And additional Cohort or through it. you make data persuade guess, some It's I the from Cohorts to data data factor new the X can include X, hoc the more FDA, post on will the from reconciling really going wondering into Cohorts in and as it Got provide try X, perspective. having you're question X pre-NDA was argument just to you around those FDA helpful

Kurt Gustafson

X endpoints, Sure. Well, critical to know you ingredient obviously, we're discussion primary and the met its need that with the Cohort that's you pleased a that have FDA. and

as for treated in non-small The previously all that FDA which first HERX the to – in a request as we're of FDA, particular – my pre-specified seeking endpoints agreed approval that. that our I in all exon-XX Those to cell. is cohort, pre had independent. for So, indicated is that remarks, cohorts period were indication they're mutation

you not happens or theory, in what X, So, in in Cohort Cohort positive a outcome X X. X, is by, not affected know

you know, had the what That's good at time, So, which that's news. we're be meeting the asking this we've soon. and obviously will once

the on you update will We outcome.

Maury Raycroft

it? Thank for my Got questions. taking Understood. thanks

Kurt Gustafson

Sure.

Joe Turgeon

you, Thank Maury.

Operator

Your next comes Securities. Schmidt line Guggenheim the question from Michael from of

is line open. Your

Joe Turgeon

Hey, Michael.

Charles Zhu

the a out is regarding should This I reading Thanks guess, Cohort side Thanks. should heavily is that Zhu pretreated Schmidt. guess, drug questions. guys. I the X, X, effects to we or this a relative [indiscernible] this on ability at tolerate taking starting And from given what I interruptions, for discontinuation, could Charles the how be off, Hey mean think had overall or those willingness couple milligram by Michael that XX your-end, exposure? less for the Cohort ZENITHXX patient to population poziotinib, about, dose?

Kurt Gustafson

for of monitor out these we signals and any of safety safety make and studies, not, what we – can't and to you including until we ordinary, know, totally of Clearly, line and this data you, see that profile. Look, as we at presume the to in you cohorts, the the least that the on the be had present see Sure. data we're you point I our sort. know, and, all with the announcement share have data know, top would going at data

that, the not complete it's away, analysis far going have know, you going saying the to to we're we're or that it before wait have year. you're to end the for So, of

Charles Zhu

the Cohort Got once of either de-result prior front, different it. the the scope X, milligram a BID dose, it independently clinicians then well of prior the profile, dosing. receiving as as around HERX schedule FDA if more And out I alternative or next treatment-naive you the in makes a sense. patients, patients made that how is doesn’t recently cohort, results my the on clinical some on receiving of patients mix XX dosing coming is, I It Thanks. my is think in this commentary enrolled interpret question daily guess, this powered? given having question would

Kurt Gustafson

Yeah, sure.

more probably you is as we're So, X once you're Cohort intended about X roughly patient imagine, patient you originally milligram a at – in can day, absolutely milligram correct. at enroll the was – sense at BID the currently started X that day. milligram XX XX the BID, can XX. once dosing a and think it after

still we day, administering are know, X it but dosing XX, twice we're at you So, a BID.

actually, be for arm better So will pivotal, us we that to helpful cohort. that think or in understand

difference there is a know, but day. when if a give a XX, you You you day between give twice once it versus

So, FDA And Cohorts BID, XX have from with we near-term, prefer with enrollment dosing to to gauge in patients but our at think but to what and they our that a you the we necessary, are we the X we could XX for – we're plans at indicated, we if we'll are the be we've continue in do here, day. know, per milligram as meeting patient perspective, favor. full going in them have would play

Charles Zhu

Got it. Thanks that clarification. for

Kurt Gustafson

You’re welcome.

Operator

you. Thank

Your Young next Alethia from from question of Cantor. comes the line

Your line open. is

Alethia Young

taking couple. questions. for thanks a Maybe guys, Hey, my

a then you maybe about thread at can able just know, on on broad ROLONTIS up and like, can just to timelines meetings. have is FDA more know, detailed just you Cohort the with conversation us X a since you re-review And kind know of you when needle] being to thinking do of of coming how the or in about Thanks. just book want talk a color little sequence, is give lastly, not you're don't Also potential your a quickly, of the Hanmi. you you You can you of why talk like wait just any confidence label? dual just bit [kind it about pretty little generally, kind a bit because these can

Joe Turgeon

take François, do you or? want that to

François Lebel

– … think, the question? I'm I sorry, you I wasn't I can repeat

Alethia Young

Sure.

your it’s around like, you months? like, you tired to can I a X like, So know, like, you you a the broad for in ROLONTIS? have know, estimate do must [basic]? it’s the in just to poziotinib on of X is just The best Second one, at guess, I on potential you why on tell, Cohort give think and confidence perhaps, you data to six a to think not then guys weeks, Thanks. FDA? bit you view for one kind your go timeline wait is addition it's know for label third but ROLONTIS little wanted about six hard on the us talk Cohort Do

François Lebel

the on do correct? first we question that So, is when Is inspection? expect ROLONTIS, the

Alethia Young

you give little timing, if like…? like, color like could Just more the is weeks, it a months, on

François Lebel

I I that agree you hard would tell. with Alethia, it's to think So

I will at you they as know, know, well, up we're you don't actively as to to how that, patient. virtual information is that ready, you actively, And FDA just the we you I've time, for don't Sheet this that to us indicated, were Pink looking this to occur. that how can. with understand important as into And make I we but make as working following you we've as we sure know, when the obviously, think FDA, have are, know, we've and they inspection. try we're and mentioned, told much know the release yesterday sure

Joe Turgeon

I'll two that that color. question just for and part add On Alethia, things

nudge what going not try this that. tell to push can you forward do I’ll we to want or it, sit are to we We around, and

you saying going down day, can you with South Korea They’re update they wait, in I'll to that. country. they're just very the and were We’re just to really I know, quite I way down. often, not the sit the just, a XXX assure doing But very, Hanmi secondly, we mention and whole is cases team like in pandemic well.

like but favor. the moving realizing, still our and to, maybe agency I'm all I that plays to hey, hoping and believe our like otherwise, doing see it's it businesses. we'll got to live, in just And good is we've we're and forward Europe So, do –

better We with have another to these in way. doing get

aggressively to sit won't back. we'll We’ll and So, as we we and with can, we will have try do to Hanmi. them anywhere try nudge whatever work do them and

François the other So give with the an two go can again, you that's label you questions. [for best pozi But I can I for exact the to wish But three] ROLONTIS waiting we date. the give on also and broad want you. ahead

François Lebel

into think So this have don't assume of the a labeling ROLONTIS a have the do BLA obviously about you all to know, is I last know, going I you normally of we're or until for you we the can details you review discussion, an discussion when because, that into get once you, NDA, the questions, of thing wait labeling a the it. – to you one get answered label.

of So, I've those in have shared that type been with communicated you we discussion. and

So question? inspection that's exact this repeat that, know, our still the can in fashion, get know, Alethia, we'll have On a don't we perspective. we an you addressed we from you specifically, you timely a pozi have Clearly, date. but think issue positive

Alethia Young

have meeting and than you X why in immediate? Cohort like, rather it far behind, not quarter, and maybe the strengthen I is might hits, know, just with it your first if wait X not Cohort mean, argument that

François Lebel

know, achieved that, Cohort as needed Well, Type I on a time FDA agreed C and what do know, you to the ago victory you to mean, we we've meeting, tell this. you had to is with we I declare agreed, we can some what

ahead. So, going we're not to wait. going We're full

meeting. Clearly, cohorts, and the our around with have aware you our the Cohort As aware to we're we've we they're indicated X all and – to they also and X. them schedule, going Cohort X are of you, timelines know, shared have exploratory that

though. it to sure Cohort if it's they're meeting, have fully know, know, here. well, before, they're may to going we independent, you So, discussion. for but want the not to see you up of all I'm X positive do they aware you negative that, And at should or influence Cohort remember, that. X come And

Alethia Young

Okay, great. Thank you.

Joe Turgeon

Thanks Alethia.

Operator

Thank you.

White comes question of from the Wainwright. next H.C. Your from Ed line

Your open. line is

Joe Turgeon

Ed. Hi,

Operator

Hi Ed. I un-mute. are mute, you on please

Your open. line is

Ed White

Hi mute. I guys. Sorry. was on

for thanks questions. few. taking have a So my I

the XX the when hiring in until Are quarter And you at getting before closer? think the launch, about hired. you had you already you on were your to timing potential FTEs commented ROLONTIS now? last Are that First, were launch. hiring you it looking off ready, putting I continuing you said you you with Are getting were XX approval? hear more about

Joe Turgeon

leading you Tom, don't answer Why that? you're now.

Tom Riga

correct. How Ed. you? of that PAI remaining Hi is currently XX So, gated being are XX recollection to and the scheduled. your We FTEs are have FTEs the

that the focused the So, access accounts and field market XX really are onboard leadership. national area, are [indiscernible] in

in preparation We ready want trigger on the in-line make and So with efforts. engaged are pull sure, those can actively FDAs our folks that inspections. to we're the

efforts FTEs we the So, staff, be the will actively are facing ready spend gets but go the we do our our of XX when preparation want for to agency the facility. have the to remainder [indiscernible] customer that and finalizing mitigate to

Ed White

Thanks, Great. Tom.

and BID? for on to I data that just [XX the or I'm data? the be of couple think the to is will on you we XX patients they milligram] X at one, And data both patients so [XX XX timing? expect François that about be a milligrams], milligram maybe mean, so wondering are going data just And how when know, to see on Cohort X, pozi, can that questions at the

François Lebel

I of would had the and on want. data in – that of decided Cohort pharmacologic the if we we giving as in some you and seen dose so dose fairly other X, coming we the basis drug fact we and – reduction, speak, way is know, the X modeling the explore you some, we Yeah, that interruption

BID And, So, and little to, day. the enroll a XX I were patient half are XX Cohort maybe patient than original more enroll, CohortX. know, add XX you we at track we ends going X, once to on half we're currently for with on believe a

the assumption words, in other So, would stand. same

with We what or you the would us to doing otherwise. they pre-NDA prefer meeting. will discuss If the at FDA know, with they, do for agree continue we're to if

more you So, today. the say, you to can't know, definitely matter XX milligram, we FDA. will you know original answer or discussing the And to the have we the XX, way need I do will than if Other with end it go one we at other. than back after,

Ed White

mentioned thanks. X, you X date, maybe at know, you the over sub-optimal. you now where And stand patients on wondering, and dose have stopped you I'm dosing, milligram and XX XXX milligram looking you Okay, Cohort just BID the milligram you X in do the to when but dose if that data, have know know, we many number were you on data, see So, patients? we'll of and of see would them appreciated, for do but, that XX you timelines how any was when be milligram that as suboptimal?

François Lebel

Yeah.

recently, XX the and BID. the patient once X BID and milligram, then and it. day – XX been It X a The patient we not milligram to randomizing XX day, Cohort a the and or we've XX milligram amended X XX at at and randomized XX XX enrolling more remember and to sorry, stopped XX once started milligram, got you milligram, we by I'm So, then XX.

on that their negatively what we're had – COVID comments, we're have, want indicated of have safety number a mostly to know, so but in have you you of around The we probably efficacy the So, that's mentioning takes you reason dosing. some we'll know, company because the I'm is end be XXX to obviously make know, XX patient we enrollment, affected patients. that will you the reporting a milligram as that simply you know, as the what here to of number because and not see to of be didn't transient And stopped little time we milligram, we certainty say BID a you going you a enrollment, on The pretty longer, before you response. that for decision but exact impact responses, that you giving dosing. we have XX number, the the our year, we information, of able well know, there's now. though, the durability assure a, but the issue us side, terms fact that, to make we and only did just And, enough need, know, know, let's it's a

going and the So, various to in what's dosing update what you in we're the you months seeing information going BID. including preliminary know, on next on, we're two on cohorts some the

Ed White

that or, hit Okay, for for That Kurt. just the this you substance Thanks. on And know, for back rate next and $X question that? you the to without R&D we the go quarter, another will tacked quarter million great. run know, there maybe substance, last expenses charge really drug that to drug is was

Kurt Gustafson

Yeah, thanks, Ed.

evaluating know, had started and we, so big quarter quarter. you we be that the line-by-line I with that we now? through you to piece a you of Joe continued will give we're of to needs in it a our activity spend So, right product, budget that it mentioned, So, going happen in is to we're our sure to spending. this now to every will are know, how for fourth into be kind drug to as prudent be related make on know, gated? fourth quarter, and happen? manufacturing process number sure substance be, should be that's can't Should as going the ROLONTIS making that, third ROLONTIS When expenses some going exited you the but we an there

how a in plan go want figuring but manufacturing sure that short we're much a to make is will answer need exactly know, you be out stays at taking we look obviously some do? there hard So, and mode. We spending, readiness to

Ed White

Kurt. thanks Okay,

Joe Turgeon

Ed. Thanks

Operator

next line Securities. from comes from Benjamin Reni Your question JMP of the

Your open. line is

Joe Turgeon

Hello Reni.

Reni Benjamin

guess are How couple good I guys. questions. Hey, afternoon, you? afternoon. of of, Good a Couple

worldwide? manufacturing should Hanmi by inspected I And the but this, many know, how does products the before? guess, are the in manufacturer U.S. plant I has FDA and been know many how You probably

Joe Turgeon

don't How a drugs with was time, exactly many, They tell know generics. in time you. U.S. this My any Asia. U.S. in have that – a started drugs actually, for for several South device drug have you I today, I got and they understanding no many when years they manufacturing inspected. we generic several were products development U.S., got out with them manufacturing. can't the you the and a then certainly And as into a how but and drugs them. expanded but places they ago in Korea that have as drugs both Asia They that's can involved tell other multiple full-fledged long the throughout from in they It's but company, at

Reni Benjamin

that Got least force, gaining it? I activities to for sales that know, you rollout sure. anything And this], of perspective, the you the managing, know, you at know, were are delay you're you when you [a aware there from, you be course Is the else that in guess that, want we hiring there actively manage from cash, of? mentioned should know,

Kurt Gustafson

is this Reni, Kurt. Yeah,

you would key know, focused think the the be, on side I business. here things mostly the commercial of

about continue. bit spoke development pre-launch will a that you sales know, think well. we on Tom activities can readiness continued for François little maintain some going mentioned, ROLONTIS and of you facility. a we We're sure as So, to team, those that And of are marketing about the state have as some some efforts spend also with the that the make

Reni Benjamin

one this one then I now? cadence with ROLONTIS, just heard to they kind And as of wait FDA off on a discussions just a we're performers of deferral, you and think have like what's to of until is, get this is one the final kind you is of or right first do back the back I've know, Because Okay. [indiscernible], of you? there the times forth

Joe Turgeon

to obviously, not the know, have but wait. do to to you François this, going things. sit you and can we're They add back authority

anything in like agency, it we laid out. all on you how with we And know, have can what's you. time to we're that's have you back much know, contact takes. work next, discussions Kind so certainly you do to can else, then they get to whatever of the willing you, So, we

moving part forward. doing this in issued As Europe's yesterday, see new said, movement they for Dr. on on because them. time it, And you issued, the already. as just the they can you first statement heard is François their this to

I'll So anything can will And I’ll nudge I them. we to the tell going word forward. you have is, do think start to they're all moving we use just to,

as figure to it we're possible. properly, you ready and know, to to right to how and do but every out quickly to do as You go try this them, have we talk

Reni Benjamin

just then And one… it. Got go ahead.

Kurt Gustafson

the given they’ve Look, us deferral.

information with them. Obviously, development it's here is get not not issued many who closely indicated, to going We FDA clearly into has about a have I'm manufacturer problem. to working very had, I've as yesterday. etcetera, seek get they’ve We're to not representation let's we're and the how of guidance just but I'm only some of that problem, clarification. say to in. some details going them aware, new communication the

timelines. them very we to we So, stated, especially has with And you expect topic, follow as we here, know active Joe to in a to, subject. up think continue will, will clearly, it's as what

Reni Benjamin

that's Got pozi upon there needed more study, the up, endpoints meeting gears until trial you the may know of application. incorrectly just just real FDA to being just be file that, you and it. coming know, registrational wasn't, And likely assume know, a with you much discussion switching of kind the agreed I kind that, the quick, you

the I what of we looking could So, clarity possibly of think additional winded kind long for what guess way what could here, exactly, asking, we you Do get? exactly

Kurt Gustafson

so the an you and on a like is it's plan, to file set. meeting agree or going go usual you FDA, you're whenever – BLA, call Yeah, then you data with your think over to this standard the either NDA

be, that's in you X, want Did our example, did over see? case, question would So, and safety a data For X,XXX I'll want Cohort see they the would receives whoever on give safety how provide for exposure? We they but beings additional human human specific obviously much efficacy the okay, to the drug. example. to example, all on

have that, from them, of safety, know, do agree So, and okay, need want they done? and We to know, work, it's see bit we like see? and a that And, know has extensive or So, goes you on. they it our go you what to on else. We done to all something know, we want studies want they do have you pharmacology, an the that. you toxicology details to they of Then, have want is to partner then database that anyway, so like, We it. quite animals. preclinical done have clearly know, done safety. you know, need they you we've what Did

you can know, about then question submission, on very you anything you them and in agree the ask the then specific So, format.

As you know, there tumors, is a need develop for diagnostics. driven these to you companion mutation

So, diagnostic come going you to have companion have, to to of know, as an kind agreement with you etcetera. you're to what them

discussing, that's questions. unusual. is but nothing to And going of we're standard for a there's what lots there's pre-BLA This be or So, pre-NDA meeting.

Joe Turgeon

Reni, Yeah, to goal [indiscernible]. is our

Reni Benjamin

Thank you, guys. [Indiscernible]

Operator

Thank you so much.

comes Your Mamtani the from from Mayank line next question of B. Riley.

open. line Your is

Joe Turgeon

Hi, Mayank.

Mayank Mamtani

appropriate and done taking Hi team, I word. for year. my from question thanks understand you're is being the resilience for far very And the

I and saw know, [XX mean, I’m limitations on, the used Cohort just the with year? about through have, you in with strategy you pozi not if in with dose question, rest if Cohort that you really, a of program. the the by a know, does the little confidence talk level of know, context first X think You of bit my I Could of dosing X move update we the to detail you about So, your you may X, you I understand kind said along more the term that? trying mg] higher Cohort you end the can know,

connect So, we down that and before, understand by to have try can to asked follow you the strategy the I'm just pozi saying the to, update. learn in dozing know, end of up a to dots been you questions year? know, boils from all the You what

Kurt Gustafson

try Sure, let to that. address me

So, let's with X. start Cohort

So, Cohort FDA what We met X, needed meaningful to have study. make we agreed this it we the to show prior we doing to to outcome. And with as had a agreed had that.

once milligram So day. that a was done at XX

a a words, trial a at XX have milligram day. positive once other you in So,

– before So, words point you that that do, like what we’re the saying pre-NDA see, we interruption dose to dose main In because it’s agreement, is data a discuss, of we to then now look, the what etcetera? Cohort we we meeting. and discussion And to we’ve the would an reduction. high that fairly the and had kind met of analyzed X, we in dosing had Cohort knew, is knew X do know, had other that simply level you for want needed and we we strategy,

we modeling, called [Technical [EC-XX]. probably So, could did a above we decided that reduce we and stay Difficulty] and we the decided still what's Cmax, some

words today is In starting little than milligram is – just because we've XX that effective, dose, other what able to we a And also, a the work, data in to tumor that's day degree is minimal what of we're we some toxicity, start. can that. and you be why But what doing low So, we a in how reduce just have XX know don't that anti the that's and XX. milligrams be maintain low as looked to like words, it's possibly that it's effective but other be announced we'll provide dose, other a day, simply And to what know you is, activity. we In not the XX day, doesn't may too term, might higher you it. and a XX once on at dose, BID, able know has and is as near milligrams toxicity, go? you words, but to still of improve some

we're milligram. what great that's news. the I and we is So dose, remember, XX have effective minimal learning mean, done

maturing, We're we We more that data X be as that's a once and data and time we a have have BID XX, We will need and X right? enrolling. and we have analyze and well, maturing more to that data. day, little

on that XX answers obviously have see we can I that be maybe will them. with that once So, discussion And it. works, hope will a will improve day the your question. all together we'll FDA. They discussed see with and that they of

Mayank Mamtani

It does and I out. really laying appreciate you it

between mg day sort by some we'll XX apples-to-apples, you and end then have you a year, know, once quarter same XXmg is and also fair? that point, So, X then first just at of a know BID so some of the or to data mg in the day clarify, you population know, once

Joe Turgeon

patient to definitely think know, longer. safety, I make said have I what So some the follow efficacy, to you you we're be is, statement able to about going

two So, patient good because will have on indication you going have in months on we the the not, you these if right on know, Cohorts of, a follow analysis may to final we BID. not longer, to track very we're some with we're of next get know, efficacy we but the

Mayank Mamtani

we the question is Yep. know drug the because obviously most And works. important safety

So, same commercial know, my you dosing, might it question little then like could purposes. for, seems you on day bit It ROLONTIS a important us next be color? just give

plan of could So, know, that fit differentiating me, your your, including you in how just longer-term remind you does biosimilars? against

Kurt Gustafson

Joe, you I want assume that. to take

Joe Turgeon

I up. the was of question, kind trying it you Mayank. sure Could make ask I right question up. I'm broke sorry, Yeah, the again? broke answer to it

Mayank Mamtani

Sure. worries. Sure. No

really that, will, the you before to run implications you really you mind? you question formulation, learn parts the know, to for dosing have the the was, how to you part does day same know, you to a question. in just the what market again, that expect know, in then do plan in confidence you two curious, ROLONTIS, compete will the was commercial keeping that with of fit year is, I end a and biosimilars? On need know, One second of your longer-term the And this in give this

Joe Turgeon

Yeah, okay.

do and and that if and that and chemo, the on further other We with get is First, the that label. dosing happens The you go a the that product the would can be work. the the would listen, year, next this trial the road, our know on want without get we biosimilars and the is expanding advantage drug point having day. from to today, that say, get a it get were a the saying you white didn't your on inject you label – is, I – and all What speak. we'll day to as so say, the down is, expand you now just that'll do sure mean. that tremendous a be [indiscernible] when be like this well the one would did day that all, the the by trial differentiation. label, reason, in can't the the label this be, the tell factors François is have clarify. would I to the make factor white was companies and a same bigger try love let's your the physicians to to I face it launch differentiating If launch to product. clear what that, be and end patients, And we chemo the – something Dr. would worked, innovative would you to other your so of trying what first cell day to tried past, advantage would same and the we and It is, blood to market the of is same be blood cell and give that know, a when dosing of non-inferior, factor, we're What get in you and really able it can patients, would nurses, be is

So where was we year, later what program. saying with is, go François know the we'll this

on part want it? I think say François is that all that of you to

François Lebel

that because waiting of know, and in called Yeah, not preferentially I that the know, this the front we're bone what in longer. was you pharmacodynamic plan, the you to have for our data biosimilar, it a of the the is means in chemotherapy. so day drug what's you has front there particular no, that the traditional after and that And, difference inspection marrow, – the that's stays positive of is SBA. and that exactly. that, the the ROLONTIS as FDA submission mean, what's factor the goes Separately, we know, growth which give called dosing, you

So opportunity us. for some up that opens

know, the advantage? drug And So the exploring, leverage to first, are you can give trying we those day. the we we're pharmacodynamic same

patient, would you you This later modifying opt BLA want, the you in a process do to on. of management and that and the it but nothing and test but soon. submission for to approval would we're differentiator, important has know, We're that's current to of we the obtain if very it's this testing know, be that why important So, doing. the need with that very we down, be obviously, further

Mayank Mamtani

thank status of last the running my study reminder impacted in quick that question, that patients and label Phase by I understood, X is the open And lymphoma or you. just on COVID? is up

Joe Turgeon

Yeah.

question. know, you we good So, –

is to we so we're So know, forward hurdles resolve, very here [fifth had obviously as as very you about focused that we asset, early updating But deal number you remain nonetheless, obviously had sites, are at the assets. with this on documentation, regulatory today, to various we technology]. we discussed know, have we late an COVID-XX. going our of We've excited a and had

making know, many Phase probably and progress, than know, centers, getting are right want. enthusiastic and but most particularly we We're X slower there. the not lot it's you obviously now dealing As We're new you COVID-XX, a they're study. about IRB with

Mayank Mamtani

Great. Thanks my for taking questions.

Kurt Gustafson

Sure.

Joe Turgeon

Thank you, Mayank.

Operator

you Speakers, to showing I CEO. further like much. this am no Mr. questions conference Turgeon, turn so Thank over would at I and the time. back to Joe President

Joe Turgeon

that operator. you, mention again, your ease. you free for listen, I'll if to call. we Spectrum. being the say connect dealing, conferences And financial interest in you of Thank feel in want part And be hope between. we'll questions, have further thank And to everybody concludes I with at some this us many please contact upcoming of to to any you

call. Spectrum. we’ll say conclude you to thank operator, for So, like everybody's in with interest that the I'd

Operator

call. today's Thank all gentlemen, joining. Thank concludes you, conference you speakers. Ladies and this for

disconnect. You may now

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