SPPI - Earnings call transcript Q2 2020 | Spectrum Pharmaceuticals, Inc.

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Operator

Good afternoon ladies and gentlemen and welcome to the Spectrum Pharmaceuticals Second 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] I would now like to turn the conference over to your host Mr. Kurt Gustafson, Chief Financial Officer of Spectrum Pharmaceuticals. ahead. go Please

Kurt Gustafson

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

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

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

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

Joe Turgeon

clinical for and in we remains addition on the to and as our pursue pipeline that, development Thank want great pipeline care development our thank focused in employees Thank a some today. what's for speaking rapidly us It's more the strong the new dedicated Kurt year even who to And made you pandemic. been professionals. second of in to We've our remain progress already patients good solutions investigator you, programs. come And afternoon on the cancer advance and about health despite everyone. I of excited quite joining half. for the call challenges continue and interest our advance we're to

for first trial. patients we're for poziotinib with that In Phase approved the our this is turn forward CMO with of XX the Lebel, announced later July, the approved, endpoint FDA. factor in Cohort this And for healthcare mutations. The primary of chemotherapy-induced to call over results brief a advanced therapy a a review date be could X late disease. updates significant achievement of we met to some ZENITHXX the the is cohort the of granulocyte-colony meeting neutropenia FDA success devastating Spectrum the ROLONTIS me ROLONTIS most the Dr. clinical no XXXX. programs. treatment active X insertion our pre-specified Let François with novel for the available PDUFA provide looking our stimulating patients If HERX Cohort There and exon with X XX discussion of will is October today. to under years. at of XX, in providers program on

financial is these We have the Spectrum I Overall, product advance and programs. to in we numbers. development team late-stage that drive competing As resources well ROLONTIS this assets this on and look accelerating. potential believe Tom say growth can I Gustafson necessary then have forward, well-positioned to place its the Kurt the for our Lebel, in forward the of call. our arena finally, And to CMO Dr. to factor through later CFO, and Riga, our commercial the go Officer and know Operating financial an our that, I more personally, market. will into approaches, it PDUFA goals. want our with date multi-billion long-term Chief dollar back the an are the to area launch reenter clinical turn development on François And market, in update preparations achieve getting progress. this to I for will over our

François Lebel

today. call Good being for you thank afternoon the on and everyone,

the is and ZENITHXX for of recent Our an lung patients Cohort these achievement for important announcement team. a clinical of Spectrum cancer mutations for trial our X positive with outcome

progress multicenter no is patients with is Canada, over cycle. the cell and a thrilled insertion It there lung Cohort since are ever once-daily conducted oral largest and received enrolled dose ZENITH in XX population of given is outcome. Patients in poziotinib, Europe. XX-day prospective XX trial approved X in cancer. sites treatment with this The patient it the mutation participating XX We this non-small exciting XX-milligram HERX XX U.S., for in exon patients with Israel a

including primary patients X.X. therapy response XX The as least at one had failed objective prior more rate of patients failed and defined chemotherapy therapies, line the of endpoint systemic immunotherapy. was All and RECIST or prior had two by

included, of later endpoints data XX.X%. to meeting receive a of events second-generation Cohort was [ph] intent-to-treat upcoming bound safety with with XX% confidence and that interval. durable with the in progression-free of you kinase patients inhibitors in to tyrosine the bound were months and drug ORR survival what seen an analysis demonstrated We year. a safety year. duration line a one trial. Cohort pre-specified control cutoff plan of disease survival The medical responses median XX% profile the an control lower other The designed type with of X.X disease was At X.X remind exceeded was The response, Secondary lower with X.X present we efficacy XX%. months registrational the XX.X% observed months, X follow-up was X. rate to a additional this to with I'll some data saw with similar X for be of median after Cohort of Progression-free of and continuing a at rate. adverse

on process requesting treated lung positive the previously patients non-small Mutations. an – these a in to or seek advanced indication with Exon cancer based XX are the metastatic treatment HERX meeting pre-NDA of FDA of results locally Insertion with with We cell the

study. And results this the X year. now the months expect review where the Top Cohort X to are reported. made we ZENITHXX end both Now dosing cohorts report cohorts and additional ago, this of been trial. the for Several line me with X by in other let we we results modification to Cohort have the from in

paradigms that antitumor these is program updating future. may dose We new to forward now on the dosing dose modification of an expectation for further ROLONTIS. to and you interruption, this in activity. about one will look I Our optimistic turn update remain to enhance Tom very potentially over minimize it

Tom Riga

Thanks, François.

months Our date two just PDUFA over is away.

provide We and our are our to progress opportunity preparations actively commercial we like market in engaged launch. update the and on build-out are in we making the for would an

if foremost, we and and First approved. look forward to competing, are ready

plan deal and execution. effort a great time, strategy research are investing We of and into our of

a have like market represents long-acting GCSF especially a the there with as and a This a compelling novel to change it several ROLONTIS. opportunity opportunity market entrant, a sharing still market. by begin billion perspective biosimilar me remains you ample willingness Customers demonstrated $X-plus on entrants. product new despite a Let is for

knowledge customer the to what have company, addition we have behavior. and deal market deep research great to In we ultimately the understand a done qualitative drives within quantitative of

one, neutropenia. the start The to Phase program of safety for with and of with pegfilgrastim severe non-inferior efficacy XXX Let's ROLONTIS X patients efficacy. and over duration endpoint demonstrated that in cycle primary safety was

viewed are and not associated for mean same. head-to-head FN have that will often most first important designed that studies a for There precursor We risk notable be customers. it patients that neutropenia, these occurs clinical as to non-inferiority, were our are in complications. considerations assets neutropenia differences prove While does it know to who is the Severe the severe cycle.

at minimizing We day looking effective increases program, in results the at the that of patient's head-to-head by hospitalization our neutropenia XX%. risk severe When also for of first Phase X was each know additional cycle. a severe neutropenia, from ROLONTIS

profile of the available impact available now This the a from The space, the highlights Additionally, potential of the the advanced the data Oncologist on Cancer ROLONTIS XX was recent benefit product patients, addition value designed over trial that comparable Medicine. results novel this of of our pegfilgrastim. and and the first years. safety the of are activity, for trial identically in most in RECOVER to in now are in The results neutrophil

The prior XX achieve and published, enables range preclinical scientific of offer platform across launch. forums. its novel full customer are development potential. presented to findings a addition, ROLONTIS articles a clinical product a In abstracts enhance of to our peer-reviewed like or awareness to There details continued and

increases in this of this type invest recently a chemotherapy. program uniquely initiation looking development as U.S. with administration We same-day over our the had to more. Furthermore, potential to announced a are and its and XXX We which familiarity for the learn KOL the suited in maximize product's sites, excited Additionally, ROLONTIS we ROLONTIS believe as asset of trial continue clinical we product. novel profile. maybe at

seeing As developments. at market we we look are important the today,

offering are health pricing. they are available in Although, is there that customers are competing savings several a care There perception biosimilars rational with the to system. biosimilars deep

a less variation pricing significant the selling suggests much difference Despite a list among Based is on which in data the average or However, ASP, market true lowest competitors. better cost price, in something the the reflects the a price, dominate price X% perception different. market cost are only biosimilars a ranging versus X% will and is Neulasta. There list and discount of offering between market. that measure also option current

have does XX% approximately market. seen the to-date we share. of not Currently, that the price lowest is represent the However, biosimilars what overall dictate

were an entrant X% launch. and other higher XX% been biosimilar since consistently command first the of one product like a and behaving priced the the lowest the market that priced If to product commands at Within the one of has typical would business premium the market, by generic share. this space a biosimilars would average expect

is dynamic, not like a with customers this this novel will provide them over they as behaving that market for control still market. and is It on reimbursement allows own. However, seeing changes G-CSF control category. reimbursement. for a we dynamics ROLONTIS. case, is Neulasta their also high product its of reimbursement The biosimilars the price. utilization lack and pricing that creates coding clearly a In for suggesting a a can't case, for CMS together ROLONTIS long-acting unilateral the total causes that of a a opportunity which in J-Code have drug are pricing an this brand-driven innovator predictability unique the along function ties These

and will On the a total ROLONTIS, we control with offer decisions, over customers have reimbursement. hand predictable other pricing which stable will our

We differentiator. independently an able act discounts will product. regard see through reference with reimbursement without this ASP a manage to innovator as rebates to competitive to to We be and

As we unique Most the consider. key three customer has hospitals. XXXB are clinic characteristics the at of really segment, look segments: hospitals landscape, and clinics, notably Each non-XXXB segments the three to strong reimbursement largely predictability, support on is is There to a influences adoption programs. and access placed value patient ASP with responsive this tailored high stability and of utilization along segment there and contracting.

playing influence also of power. engagement, segment we the the providers in time to That a undoubtedly very the by us majority their available market across strategy intimately aware actively and this ready of ensure them. are of Payers said, a it’s understand an differences compete ROLONTIS are enables and we tailored are team to being and have decision-making engaging our to is are role partner all increasing hold market important Through We this in them. is that payers the option. that still this

Regarding the we support to competitive ROLONTIS. to have a infrastructure fully the build begun commercial and launch team, of integrated commercial

ready In within Our marketing, of team team medical focused closing, we and members currently XX board. Once and XX compete. affairs. We are reimbursement, supportive staffed, already on a and has a operations commercial of understanding team sales, have we our of FTEs will deep oncology approximately fully have to care. commercially access

We so to With the the that, look date do the I'll to over October. have the call PDUFA in all turn Kurt to review and financials. to we forward ingredients

Kurt Gustafson

Tom. Thanks,

prepare launch of million expenses R&D associated poziotinib the year. previous higher purchases to expense primarily in drug as million of product, with $XX second this quarter well for The clinical $XX.X the SG&A versus expense the of as $XX.X in substance we XXXX R&D million million. ROLONTIS was versus trials. Our increase costs was as relates $XX.X clinical for

expense is that We us inventory, this fourth approved. until of zero will actually rules Recall R&D the purchases inventory we be expect cost when quarters in require this to make additional a sell the inventory the expense product this and accounting year. to reflected of goods. at third it ROLONTIS But as

proceeds stock was This versus million marketable XXXX. our cash and prior Our the versus million the Operating $XX.X cash marketable This ended quarters. in was in the burn, cash $XX.X million burn which costs; raised was backs period loss last $XX overall cash the The comparable is This outflow out not which sales and we a is the public quarter basis, commissions. on compensation the $XX our plus X. the period. balance year operating cash quarter. $XX change securities we actual non-GAAP include net better under for day of a primarily We second million financing cash quarter a in the from a million amount deducting in in for quarter Cohort combination the net loss does our was in offering for few that $XXX ATM after which million July is measure million late any $XX.X from underwritten with the with million. consistent the facility, quarter securities. utilize And our $XX.X proceeds of the from for after results our announced of in

of of plenty me $XXX our runway we call If continue QX back assets. This cash the to have Joe. over of million the our pro balance, us and balance forma development to provides a that, you late-stage were hand $XX with With let cash million. commercialization to would add to the

Joe Turgeon

Thank François. thank you, you, you, Kurt, Tom. Thank and Dr.

for like dedication for open I'd Jefferies. could it. Operator, your line I questions. hard I'd work that, the remarks Maury commercial our everyone's team anticipation and Spectrum potential these build-out Raycroft and from see to you up in times. the continues their and launch unprecedented like you. approval ROLONTIS. lines first of have can pipeline I'd in And from outstanding thank on to think you with our questions, open [Operator to for our that entire from the if We Instructions] progress question Thank make for appreciate

open. is line Your

Maury Raycroft

Hi, on taking questions. updates thanks for the everyone. my Congrats and

XX% on I this think But calls a little bit ways. in pre-specified other you number I of different for poziotinib. again. have been a to wanted asked guys into couple more just dig the

established And ORR assumptions can XX% thoughts the that and FDA? pre-specified so, I'm went and wondering pozi if was provide for how into you with that on more number background this

Joe Turgeon

speak Sure. Maury, Yes to good you. with

literature. So the literature is you the us for but from number obviously HERX discussion And there derived guidance. as XX mutation, of in drug exon a the approved a is reports know review there no giving of some

part cetera. patients, Now small patients the very small of the these one data analysis, a usually literature in a retrospective et that's large number is -- number in of or site,

as would and analysis with communicated So After endpoint, was this -- that's FDA. arrived. in our then that a pre-specified discussion And a there finalized were with was how it what the plan. reviewing information, calculation be statistical established FDA eventually obviously, various a the

that's ask, that the probably So I data. the question. little -- doing? specific your than one EGFR was a It answers literature yes. hope for answer you And will was the -- is is HERX different The

Maury Raycroft

you FDA on Cohort Got how likely you're with the the Yes. guessing in additional to in call you on some that this Yeah, could helpful we're it. you resolve data and guys And that's And some -- last Cohort perspective. it. ideas the seeing resolve of Got that will explanations. of X it's about conference X. versus talked then this differences want

about you the address and so if observing pre-NDA and you're Cohort in just wondering to X -- differences are the some how a is I'm this place X of Cohort plan meeting? that thinking there guess, I in And between

Joe Turgeon

Yes.

that here. believe results. with too, difference. in part, by is could ongoing receptor were You're time we'll at a main some don't year We and enrolling We the rationale and of think the had need some provide obviously We in absolutely obvious necessarily right. think is play that the that I've the the gained time doing There different analysis to is investigator that expect there patient indicated, one explain, they last that drug as the explain to that's here. the experience I explanation the so result,

site country -- cetera, et looking So the of medication. use investigators, we're are for there difference concurrent difference,

possibility So, all looked could that sites are from mentioned. particular of we a in of number being speak. X are as Cohort those different. at be factors coming Comorbidities the There is any region

analyzed obviously and factors those FDA. the of that intend all present to being So are to we information

answers question. So that I hope your

Maury Raycroft

does. Yes. Yes. That

think there. stop Thanks questions. taking I my good. I'll for that's Sure.

Kurt Gustafson

Thanks, Maury.

Operator

from next Cantor. your from have We Young Alethia question

Your line open. is

Li Watsek

for for on our Li Thanks is Alethia. This guys. taking Hey, call.

for in kind talk where work just of the follow-up to a sort preparation association as FDA Just drug in outcome? a cohort, examples any but the And and frame other then analytical of meeting. you of FDA? us situation not was and about what to similar you Can give one try of sort your are maybe this doing work what currently

Joe Turgeon

I FDA the cuff, example, to off of one the more all you've four that the an I another. I an importantly, independent Yes, with communicated but agreement you potentially give got that we Street and of recall -- mean, can't were our to that we've think had cohorts I

what is one indicated, that's explain account. looking That that as other positive negative, into So is a if one reason I've those there is number we're that the And taken of is to means difference. was and fine. that into

So, you EGFR fact that acceptable FDA. I you, to way, given not was it we're and activity remind -- there. did seen shape want, had endpoint if we reasonable the the that in should the one think meet quite that that clinical want pre though, to the be -- we --

EGFR. the was an So activity it active had certainly but not of there area. there reached required drug wasn't, that response we was kind evidence in of, pre-specified, had no rate It

Li Watsek

patients? hypothesis see our maybe Okay, got around harder it. relapsed more And any maybe or then patients versus whether refractory be in it activity easier frontline is there might to or

Joe Turgeon

Yeah.

these generally multiple I higher. pretty forms other you better the of have at that organs their but literature, either are We've indicated their accepted in not they disclosed if they liver, look respond first-line have -- in first-line their is meaning the more bone it's patient previously not having chemotherapy or to well better the better We because bar, could bar that that of think in have possibly rounds therapy. all shape, protoplasm, received part, in drug, kidney, reserve, marrow and

perform for but bar our pre-specified little endpoint first-line is a expect we So higher. would the to betterm probably also

Li Watsek

Thanks, guys. it. Got

Joe Turgeon

Sure.

François Lebel

you. Thank

Operator

We Wainwright. have your next H.C. from from question White Ed

Your line open. is

Joe Turgeon

Hey, Ed.

Ed White

Thanks taking questions. guys. my for Hi,

then the you one and reductions. -- and these that try know the So going dose the get schemes and stay a patients, cohort? with one patients. on out When have third-line different last dose And patient back to had discussed data to and follow-up thoughts maybe this dosing there of Any had question. second-line interruption, pozi. Cohort I you're from patients me XX% X revisiting to you're on the trying address from XX% I

François Lebel

Sure.

got you've memory. So, good a

guidance have So in the because analysis the with line effect and we to number only profile we X X now is class. given ongoing, have side – indicated Cohort – the similar right the that quite was the in Cohort but

different obviously we're So I BID. more probably -- looking XX at we're as that eight dosing, to the suggested we milligram, six data my looking the a at sub cohort in and meaning, and prepared have statement, milligram cohort, XX and say, as look should get and milligram I anxious XX at at remember, we you data, or

data, So that the the get anti-tumor modeling as the live we potentially should to anticipate improve be we as tolerance, given and given that to able as activity. well look forward the we we did,

forward tell we near in to you So that's new future, today. results. I that with all that these can you look getting share data the we unfortunately, so can And

Ed White

thanks, Great, François.

François Lebel

Sure.

Ed White

you had in you us X. while about gears, haven't FIT on an wondering just question platform, Phase on can switching I we're talked the a give if update just the then And a and

I you at were think there. patients XX looking you said up to had

there you're the if see you there's also enrollment had COVID, how FIT increased balance that on Thank is about if can to you. what and now with other the you've – going opportunities there expect wondering, the if BD pursuing. Just thinking from have sheet, and this cash is we – platform

François Lebel

So let divide your me question in two.

have well continues. some in to FIT, that that the that we for to or on priority, a I this late-stage as impacted ask numerous getting The ROLONTIS imagine, and you making meeting. as the year, of won't guidance point, the we don't It high good all, but on additional a than of to any we're can't, our focused now, are and about program want conducting heavily other priority. some venture as FDA that today meeting, on give focus progress. pre-NDA analysis pozi other of so and the question area pandemic in us has the can program been First our addressed like on ensuring at We're to right FIT by But hope further give now FIT. program say detail I before take end the

Joe Turgeon

active Ed, not the move forward. company, and that Certainly, business looking assets that sense the part. at our development not program, different week extremely so answer BD for a make team Tom second goes his by company I'll we're and

a basis. very So aggressive absolutely doing we are that on

Ed White

Great. lot, Joe. Thanks a

Joe Turgeon

Thanks, Ed.

Operator

from We Schmidt Guggenheim. have Michael your next question from

is open. Your line

Michael Schmidt

X. Hey, lung standard on type guys. mediated question. than had for treated HERX a just taking I XX are the are patients wild are how of I today treated? Thanks differently guess care? follow-up guess, I cohort And patients my treated cancer study HERX as exon they

François Lebel

Yeah.

and/or no of as there's general, chemo that's is There combination know, checkpoint or a chemotherapy checkpoint. second-line usually time, you guidance and the been HERX when patients with – treatment. In inhibitor often first see of triple we in the a in these with combination So, see immunotherapy with provided. various approved

in have use but not patient the seen information quite second it's patients what our of makeup in we treatment the in in provided study, typical to line. is So, about those

Michael Schmidt

the we patients? patients about all-comers know lung of do cancer prognosis what And non-small to those relative cell Okay.

François Lebel

Yeah.

in some response usually two together looking for rate. consortium. this. European multi-centric on study have consortium at – as published, literature was or look what that looked put data large of look relatively there, There's you if consortium there mid-teens my there drug. at sparse, but remark U.S. at is and is – not a is want. there you There variability and obviously, you something second – no but are data was uniform that the at So approved one And the if is in The a depending I that earlier you're is line, said

think XX I mutation HERX than the data wild that the with does type. patient in literature overall exon prognosis worse in though confirm have

Michael Schmidt

Okay.

Thank you. you one, drug clarifying I for And couple a I is, maybe are will of the Thanks my differences. you then mentioned achieve Okay. just how although non-inferiority that, differences marketing question And compared those there. guess to on questions contracting number maybe demonstrated some effectively be the that. ROLONTIS? some, ROLONTIS, to last, with guess able efforts your placement use there formulary and to in

Tom Riga

take I'll that one. thanks for the question.

So insert the publications. be The the studies a to available, it's non-inferior in are designed differences non-inferior. domain, package public indication, will have the our

Our obviously medical those to will have group response affairs in questions.

base in it's study. will show But label the label of will coming is the the if forum, that label So available, the does identical think do results is see, approved, you that non-inferior the be when gate. out expectation nature. the I public of non-inferiority And a our not

not that will ultimately head-to-head not you a about The will pathway, are products differences A the and in I pathway pathway. XXX(k) are in clinicians they those so ultimately that have are the product labeling. will think, that biosimilar studies. and evaluate when novel, there that represented think be BLA nuanced not

Michael Schmidt

maybe J-Code. its a to contracting down or little Got an terms then better could that Maybe biosimilars it. to obviously bit on. just Neulasta lot have help code, a of access. advantage compared own I obviously us mention you understand guess, be Neulasta did of this so ROLONTIS that I comes in will And and think how

Tom Riga

of Average Price. comes Selling predictability down think to it I

between I and the is a are And not to uncertainty. I in Price. product, think of high it else's So stability enables novel product looking drug our element causes of a products, Selling unique predictability a that impacted interrelated think and customers for innovator predictability by an these us of position Average case multiple our is behavior, provide in reimbursement when this anybody reimbursement having a of bit utilization level categories, that and

it and community So have reliable time. that's expect. I a can Selling helps. something It budget three have of among when it advantages enables a think category budget of partner with that the what predictability Average pharmacy know see with, a term oncology And you two helps you stability value within there's you or you you Price, you proposition planning, to that's long that have is a have the over and bringing a helps drug real just that or that key. top And number

Michael Schmidt

market And thanks. dynamics. then last one Okay, on

I market's think on said how and traditional over positioned? the holding views you – I Onpro that would have most any guess, recently is out the think be of and competitive I guess Onpro the long-acting segment is Amgen market up competitively right and GCSF. you're half the broken do I actually the now where

Tom Riga

Our compete intention across to is full board. the

of value value. I about challenge correctly. just You percent and going Onpro contractual and on game of we're off stated it if if that's market the XX-plus clinical does based think or theory represent to the premise that's based stickiness

determined. that's be I So think yet to

the But the across compete. the to forward when the or market, COVID how approved think advantage Onpro, look given the If as we it'd this we added be – share the I just think administration vehicle the could innovator, whether provides fortunate I pre-filled in premise we're you October, syringe enough dynamic, in challenging as well of it taken visits. an But it for Onpro. second office if quarter, regardless uptake be biosimilars, both has of limited look at from biosimilars of especially we the to

Joe Turgeon

they before got is out, discou,nt market Yeah. share tell came when a added X% memory it on first you time when you I'll and a it down and top. long that Onpro took market the lane when add, can walk watch share I if it got

the was practice saw off remind driven the it you. beginning, the That discount. take So -- the is by didn't the it's and it that managers in really doctors clinics and I at -- office was the so motivation that

Michael Schmidt

my you thanks Thank so great. questions. for Okay, much taking and

Joe Turgeon

you. Thank

Operator

We FBR your question from Mamtani [ph]. Riley next from B. have Mayank

Your line is open.

Sahil Kazmi

Hi, is the This good on Mayank. afternoon. Congrats Sahil on progress. for

a just brief question us. So, from

the you most get Cohort wanted initial And to Cohort sort expect to this FDA and been in on having you're color just the of BID even maybe of dosing addressed. But when the some the think questions X have so? into this look a context preliminary our something of there, in filing, to the that kind data prior I is have X you'd of engagement have strategy. with meeting, enrollment

François Lebel

Sure.

I [technical to at -- enroll. we the difficulty] we Cohort have the balance BID dosing. -- that think X indicated of also patient was the And we've indicated modified So roughly

-- And announced previously. a has that the here preliminary Recruitment, by by impacted have be information cohort. particular was the indicated been we we I of pandemic. that will bit certainly different we as on anticipate that So little cohorts some before, different pace discussing at

that Cohort questions, FDA obviously, the with and label we're that a receptor we the an look that open would it's expect to X at the FDA. will it, that It's we're at Given study have data. same so looking good we as discuss in would position

Sahil Kazmi

timelines between Great. maybe this a just you lag Cohort around follow-up. And brief us FDA then sort the remind of Could XX-day of PDUFA? and the time for the engagement X

François Lebel

they the within actively and The preparing request that a meeting, FDA the if meet grants on that meeting process you starts and XX days. is so clock documentation. you usually working we're with basically Yes, pre-NDA you

you of you kind have have time that book. you briefing them provide the by know submit ready So, discussion, the you're to request, have to to the a

we're So, the together. book actively putting briefing feverishly, working, on

very So, near-term. we requesting the meeting in anticipate the

Sahil Kazmi

color the you once Thank Really congrats, again. appreciate Great. and guys.

François Lebel

you. Thank

Joe Turgeon

you. Thank

Operator

I time. now Sir, turn CEO. further conference like Mr. would to Joe back at Turgeon, no this please continue. showing the questions to I'm

Joe Turgeon

healthcare conferences in participation operator. we'll your of to coming in and several the certainly We thank the you, be And I'd for in by connect with Spectrum interest, and your at virtual call way, many like will. you September to And really hope your today. Thank I up investor here questions, we time. participating, in appreciate Pharmaceuticals. that all you

the And have or in to for thanks further it. afternoon, a need in free great Now, interim, again appreciate if you We feel and additional your interest us contact information, with have please listen, any that, any everyone. questions between.

Operator

a gentlemen, and day. have and call. you conference Ladies participation concludes this for Thank your wonderful today's

may You all disconnect.

Spectrum Pharmaceuticals (SPPI) 10 Aug 202020 Q2 Earnings call transcript