SPPI - Earnings call transcript Q2 2022 | Spectrum Pharmaceuticals, Inc.

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Operator

Good day and thank you for standing by. Welcome to the Spectrum Pharmaceuticals 2Q 2022 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions]. today’s being that advised be conference recorded. is Please hand over Senior to would President now speaker conference to like Operations. and Grabow, I your the today, Corporate Strategy of Vice Michael ahead. go Please

Michael Grabow

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

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

Spectrum Chief Pharmaceuticals CEO; Joining Officer; will Tom me today on Chief and Lebel, the Riga, Brennan, Dr. Nora from Francois Medical call and President Officer. be Financial

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

Thomas J. Riga

with ensuring business further one, the FDA we are we reducing prepared successfully late two eflapegrastim, towards under have the stage advancing This both our review the is today. Poziotinib gaining operating assets; work and following the and launch call to FDA in of a three months to thank continued beginning three, and on for burn; year focus cash the our which products. Good late we both us and two, our approvals on objectives; time Spectrum key joining agency. are assets morning as for you the active stage pivotal of for approvals coming Since

eflapegrastim. with starting highlights provide me Let

under of The is in review than the with PDUFA FDA drug date from BLA today. then Korea inspection South Our by substance facility preapproval conducted a Hanmi’s less Xth, month active FDA. September of the and with a manufacturing

As completed preapproval July space comprehensive inspection inspection observations system, practices, overall early this resulted quality critical The with approval. was examination resolved. inspection previously, I manufacturing step was processes, The two in of our control. a for of stated GMP a with which were management process and

in final and action. have We diligent FDA effort await enabling we appreciate review forward to look their their regulatory making and We with subsequently had final that the discussions the process is FDA the the decision.

Let me shift Poziotinib. to

insertion mutations. our in a and the is global In designation NDA is XX, under second metastatic is of of patients This quarter, with of important fast support accelerated This cancer, non-small exon the pathway. confirmatory advanced required and lung a process. study Our November agency with date locally XXXX the active advanced and indication for the PDUFA initial HERX cell XX set product treated, harboring an in track approval an or treatment approval has on previously review step we is the application. an

readiness efforts NDA, when the share the available. be NDA. the kicked We discussion context the the approvals two package, We will We the in year, ODAC important of commercial of NDA overall enter Poziotinib the that can that these it dosing, September this look FDA in our Poziotinib high. additional markets regarding and In role anticipate and The have becomes XXnd package unmet medical the upcoming are for in relevance and play the actively enthusiasm discussion to treatment for the clinical highlight we addressing that around of Poziotinib meeting preparing the data is a to ODAC forward will opportunity will later current data supports ODAC need. include an benefit, scheduled risk off the we to the that information discussion landscape. meeting our centered the is anticipation

commercial pharmacies, infrastructure to in group to customers, we leadership the engage and launch we party are ready third purchasing organizations, and place key optimize ensure is Our payers specialty trajectory.

launch and marketing, to commercial ready commercial sales, are affairs. We and approvals Poziotinib This both and fully respective upon their a operations reimbursement, includes infrastructure. medical integrated eflapegrastim with access

needed our both one products sales with goals. have to will and resources launch achieve we force believe We the successfully

our process been support a our strategic have infrastructure with approach expanding efforts. now [ph] in have built of the FEEs and We is in commercialization to scalable that

we burn cash stage to Moving concerted have operations, to a effort while investments optimizing in our assets. operating made our late minimize our our

quarter the second to the As ourselves in of cash the see you reducing we accountable organization. financials, are holding will burn

I company familiarity period is Chair to Directors team the to felt. on CFO update ground of May, While progress. With financial to see with role. successful of be as Dr. prepared now as time expenses and new clinical Nora's our we Board Spectrum. Ms. to hit will the Nora's of her SG&A a in for can financial will increase organization Nora more continue there Lebel’s discipline the short approvals, become as running call product call you and has In being Lebel in be Dr. impact expect an after of the to post that detailed a a of first lean, highlights announced In and to previous effective, Her time, her deep company. will is our the appointment Brennan the development the already reviewing remarks. new on the turn a the her over allowed we she knowledge This Audit

Francois J. Lebel

trial. positive based from this pleased Poziotinib be under to glad cell HERX FDA. are you PMR. undertakings on lung filing major the R&D treatment is ZENITHXX our today's the and our the data and strong FDA exon non-small X patients The is we achievements. the team have morning, review, report step external fully are currently actively on a cancer a to for unmet from and major towards population supporting a with -- mutation. advancing preparing These that engaged a to of and The with treatment Cohort need. advancing call XX clear is Good safe a outcome. teams with internal with and bringing effective is review I'm active a There successful is confirm patient everyone. medical We ODAC The is Pozi meeting that for clinical intend on the latest NDA to

specialists an with Lung TKI have a treatment event landscape. lung insertion the our limited treatment addition cancer have harboring dosing data HERX starting extensive class dose. confirms at day exon milligrams be welcome exposure We profile with adverse patients extensive experience response and Pozi dose. would per generated familiar to as to cancer effective The that options XX XX is

Our randomized study is confirmatory underway.

World meeting, as largest We Cancer multiple of conduct Lung interested to returned highly in have study team extensive look leveraged countries we where with international ESMO XXX forward the CRO as at our engagement targeting study with HERX We the meter XX XXX enroll study harboring from randomized one patients international receive interactions or XXX designed had continuing to the are being cancer Patients is global to of mutations. will IV cell three to versus with into X BID Pozi two every treated XX square exon Patient PINNACLE per and weeks. milligrams six at multicenter lung non-small previously this thereafter. evaluated of docetaxel upcoming administered investigators. to Meeting up with PPD, every active the just six to milligrams XX I investigators of the our one be many experience weeks administered week sites.

docetaxel rate to over power equal on than safety and primary design have profile smaller secondary line or positive a now Poziotinib The data We docetaxel Cohorts is now XX to lung Pozi. objectives. control first endpoint OS, provide HERX would Pozi for sided Separately, for algebraic largest the progression I safety of program patients [ph] have mutated superior XX% well Following insertions of that patient and XX be line as has disease. HERX achieved This cross clinical rare response, two will in progression of in survival second the ORR, disease free to Pozi that allowed ratio the is to hypothesis will duration and test characterized a of with using and arm. the two like exon our cancer, X.XX highlight exon set [indiscernible]. to

in ESMO for data be HERX being this a prevalent second in non-small the mutation, to in The at Paris. presenting most on data in Pozi shows XXXX so mutation activity new come XX will cancer. cell tuned. More exon held stay with of We September high level GXXX_PXXXdup patients lung a

As see, and two our solid regulatory make can we on continue late programs development stage to progress strategy. you

to call key turn Nora review posted the as you I We now will we additional financials our quarter. the will milestones. achieve to keep for

Nora E. Brennan

leadership kind thank you Francois I'm to a introduction. truly of your you, excited Thank Spectrum’s be team. and for Tom member

is securities, million XX.X research second to expenses the deprioritized to the with million quarter comparable XX is overall extends strategic same company's compared in our XX and programs, of That decrease $X.XX share was in runway general, the company of a Pozi, XXXX. to and million was year. loss the payment development expenses. XX.X million, for as related in the were the in Operator. restructuring. leverage of decrease due million net while The to burn XX.X to plus million to quarter to to quarter streamlined efla personnel XXXX. into XX concludes loss call the cash XX late in of per ongoing This primarily the was XXXX. period our the optimizing overall compared other period million We the as in strategic in the million or employee related was for in For remarks compensation The to in cash same Selling, decrease ended compared cash reduced of in continuing Operating XX.X million headcount of total The and like investments in the XXXX, due second X.X share, X.X expenses. million due decrease benefits expenses per approximately reduce of stage burn XX.X or and operations our and quarter, prepared which open net million QX, same questions. were expenses decreased marketable period assets. administrative $X.XX and last from primarily The period I'd XXXX. part to in the approximately compared

Operator

Instructions]. [Operator

comes Maury Jefferies. Our first question with Raycroft from

line now is Your open.

Unidentified Analyst

is actually Hi, it Kevin.

Thomas J. Riga

Good morning.

Unidentified Analyst

is today our -- update actually it Kevin is Yeah, on on congrats Maury. taking it for and for thanks the Hi, questions.

FDA the So with totality a they focus you've are data you of or guess that [ph] gathered said you just of And and Pozi, speak dosing, dosing, on the BID I X for you there just topics, it? number X? in sharing the can with would milligram proactively the starting have adcom requested including to Cohort

Thomas J. Riga

Yeah, thanks you the to for Francois, that want handle question. Kevin one.

Francois J. Lebel

Sure.

reminder, a agency as number the with had was on said So, X, have the May though, the and that of versus milligrams all this to discussions to the a of we basis of the we the did essentially we data attributes QD. had that shared QD. as BID Cohort up have of file Having year XX which dosing

have know a So FDA further topic modeling ODAC has for view what up -- to expect we will come we also response, but that extensive conducted that also exposure we're any that I suspect and and fully of address we the of we that questions. prepared don't discussion full during the FDA has. And continues think sure, we which have,

Unidentified Analyst

lung then just out Francois success cancer? thank might on you set this what about trial? confirmatory soon this latest talk read arm with X, some would Phase just thoughts other arm Okay, sort are consider difference And to Pozi in do, the and your the know as be a are a using you of Xs docetaxel then, there to what PFS can in for what control Phase you I

Thomas J. Riga

I'm -- sure of the the question control? first regarding what your not So, was the what part

Unidentified Analyst

might the data? guess, on are in historical based what do expectations, Just arm terms control or your I region of what PFS,

Thomas J. Riga

do months, of the nearly I largest that's study with the think the the about the our of I three randomized study a double talks to to X we PFS hindsight and order expect so the that. to fully but PFS in expectation. results, obviously you to X.X months But Right, dosing randomized [ph] see with mean, have potentially

Unidentified Analyst

prior sorry, one and last Can other to the say if on Congrats remain any factors next getting done. re-inspection Thanks PDUFA gating great. date just there's month? you on that efla. Okay, the just

Thomas J. Riga

labeling. had the the Xth. provided. Yeah, our know gating discussions outstanding And We've our But and closed. last Kevin, there it the subsequent looking issues perspective, FDA final we're on been action has and is date today, factor obviously inspection forward the All are to documentation has from active from holds on and been standpoint, we decision. no September

Unidentified Analyst

Great, thanks, back Tom. Thank the queue. I'll you. in hop

Thomas J. Riga

it. Appreciate

Operator

next White Please Ed standby comes The from Wainwright. question for the next question. with HC

line is Your open. now

Thomas J. Riga

Hey Ed.

Ed White

good Tom, Hey, morning.

the Just upcoming. perhaps questions of you have two a couple potential that on launches

going question expenses You the the about up gave later. of as you us force there into sales the ask the just I'll about be Well, maybe how the we in. a should build ask little stop I for force SG&A leadership wanted year comment ramp up to and thinking the next half second field just team? sales on

Thomas J. Riga

frontline in country. they're Yeah, the day preparations expectation Boston the deep identify and really, incremental obviously overnight to And place, day have FTE, enthusiasm team of work to the they've the has infrastructure there their folks. Their won't would XX around an in located is and has spent happen had our plan strategic in expansion the also is we're The country here time begun we've We've so of leadership total set. be in a so extensive one lot actually around excellent. XX leadership strategically been and salespeople. one time geographies commercial taking team was plan and done commercial but really their commercial the those that

burn, of to burn is will relates overall if by to company I think XX% reduce towards. of what historical and cash it's said about it performance, our with delivered look focus have the what this guided in see to I at cash you a strategic as I your operating way Like XX%, January. is So quarter, the we've line be you that. we SG&A we the in had question thinking this We on think

If expect you moving the items pretty at R&D, that I to forward. look line be would stable for

organization fully increase our achieve enables goals. modest launch is a SG&A, mantra see anticipate to disciplined lean you'd that during think I be us especially a to timeframe. going that I in But and our

look would during put I I SG&A and for at would this period. modest launch quarter, So increases some the

Ed White

if filed just since it's perhaps market. then on know And you GCSF give the been for Tom. you thanks your approval. changing Okay, can thoughts us I first

we the as head your are on what So, launch? thoughts market into

Thomas J. Riga

we're both based this do knowhow, to enter have be. no see qualified as to -- I still well have billion we a that of novel it we bring we market. will we as And $X are asset we we the competitive to thrilled market, a delusions market, experience, think it FTE think uniquely how as will it proposition on unique

biosimilars the the this to recent because I to assertively segments, of business mechanism think the market data the will and time time key last different product we its our core taken opportunities I the the as prefilled in each that in leadership as drivers each the for on bit the most pro, think question, the has of come segments. the of will enable well is arm which than spending more have. of with And share enthusiasm with real your with quarters to down stakeholders. I We've ever innovator, in ability in team, XX% device business over over three actually look increases the I confident which the commercial and we syringe with having at a key study the our the And at our delivery unique us will I'm compete pro to think execute. as after go

Ed White

move questions. Thanks I to Tom. of if And a couple over now, can Pozi

expect as in you'll launch expecting XXXX, an sales of the season, approval for be the by is And about you your are on of there how beginning just just How potential question we the we should other then the be thinking XXXX, uptick the launching a versus season. holiday sort be you get a slow into holiday about and European that? thinking what's strategy? the Pozi, then thoughts and date, you into If outlook your ramp XXXX should PDUFA

Thomas J. Riga

let a So time. at take one those me

that's -- holiday question your molecule. for was think So the launching a with outlook I small Pozi,

of in a probably be product, I lung difficult a the that's is ramp niche slower will the there So therapeutic much time focused But And a between very mutated a Christmas getting the out Thanksgiving the that always we think biologic, than faster channel ramp a cancer of and through inevitably, with force. rare is is time. on population.

that will I of launching So it anticipate product ramp if be force slower, and the that to would during season. But in especially we be the period holiday XXth. gets the approved on dawn out

key September, an the date have it time get think working on the on would with call would relates stakeholders, it for engaging would the positive day be product that working then clear to key Xth one team, a when timeframe But you As in the launch and We customers. our with an bit of eight that this channel. of action with or contracts five approval of product to October actual channel. out more be efla, available weeks to becomes in one the assuming depending would be and situation cycle aimed in that's I the to drugs the

other your think around Ed Europe. is I question

we the outside just population. have We've initial So Korea of Europe had prevalence China rights asset. in Poziotinib, for rights, the particular the of discussions for specifically mutation U.S. less and worldwide the Japan, given in way by reminder, that

and approval a U.S. for business of gaining But focus is become initial we in ODAC the see more opportunity. outside Our strategy. development areas do as a primary U.S. vehicle the today the about a would that

what in approval that If for that post largely you're approval assuming there And we licensing to for approval. conversation need see I think it's -- receptivity is would the had, asking think U.S. post an opportunity accelerated specifically, the it's Europe. about to an be

for approval, is capitalize the of on mission prepare lens territories here through business other our gain So the ODAC, and first development. the U.S. then

Ed White

thanks Tom my Okay, for questions. taking

Thomas J. Riga

Anytime.

Operator

question. for by Please stand the next

comes Our from JMP Reni Securities. with Benjamin next question

Your now line open. is

Reni Benjamin

almost, no into Tom give that on Hey, inspections. all solved that sense, inspection. congrats the it on you've Seems have you love is checked -- Is have a issues. and like maybe And us of and color like it, step. that question. hate seems to were I boxes gotten there gang. that's gotten since Can more that last anything been just outside -- it's the say that's there, my review already it you conclusion discussions, the that a a seems now the you just formality is all the sense foregone -- get mentioned issues coming. to an for approval -- but Thanks or FDA it inspection I'd know they're everything like labeling there is get resolved? two discussions, like they're of said, like kind almost the did like continued have been XXX% the with observations completion taking remaining and is done, that of you the labeling that feedback is some like longer

Thomas J. Riga

me Yeah, time. a so address let at one these

is conservative, anything more formality. don't much I'm I a So think

I Although appreciate your confidence.

those I storage think, of in two it procedure process addressed needed there one observations inspection, areas, is with done with be there the But were of temperature updated. that needed ultimately, that was the be site, of to the day. in were on the key the to the mapping one inspector labeling was Xth there as to examples the observations, that relates

comprehensive and a the to after inspection we minor, provided writing inspection relatively of full data, the subsequently perspective, end in at FDA. our the then both from So

FDA that approval. and absolutely come discussions done come our always questions they there's comprehensive, believe think until going discussions no don't they'd that there's you back we've be additional has conversation. to from but something So I should can if been to labeling agency perspective, the from The ask right want, the have back and says gain both the final we like. standpoint,

point in call see right cautiously So hand. that I approval but I until optimistic we're the obviously up optimistic it

Reni Benjamin

on question, for Ed's dynamics. thanks the alright, just it, of putting ton market then of Got color. a in building that you're current And kind

you you then hit or like we're And of does $X and from say, market to internally, -- on start share, let's to ground what three a continue pretty away, you're going gain billion peak month where just gain year do and much market market viewing just kind review now, one. running initially us Can you the opportunity? for guess like you a current this how look You're share? day do your I to ultimately, years are where

Thomas J. Riga

can if me Yeah, so me and try, assistance let I you let offer need if me see you tell more. some

about the and three trade, specific States every is administered think way long million there's of year. that break out we there's GCSF that hospitals. about in of units clinics, non-XXXB is So X.X acting the classes there's into this United We XXXB

there customer understand equally drives both and know the So time, a yourself a enter surface, we've it what time are out, is drives spending the quantitatively But market, from experience things classes got. ultimately are that how And ask of spent competitive what lot of on relatively in important you to of an turns into decisions decision. leadership the differences you it what we've drives each and trade. really qualitatively anytime of those the team equal Because and decision. as ultimately

each trade. spent beginnings with And strategy. of that's So totality, the where going in understand those of product the our ultimately decision garner it of drivers to of we've resonates classes our offering time to

their details stakeholders, a market lot relatively think, thorough have number a think at and I relates competitors, calculate decisions assessment. And ultimately how has look I won't it it's publicly, with when of we gotten marketplace the of we and really job driving But you So into this what's as size we I done in in there's take team a P, Anytime that this this matter. to haven't today, and a of today. complex. share here

the put that forward competing a intend only ultimately in, together pretty specific week comprehensive to -- plan to both the look And specific going to engage I team doors what we we're them. So walk that customers I've that is reviewed has with. not how those and we think the drive this decisions,

Reni Benjamin

Got it.

Thomas J. Riga

question hope know, didn't hopefully your on insight. and I some peak you helpful. that's I that answer peak gives sales I but share

Reni Benjamin

it no, does. definitely No,

expiration Just sort maybe what's remind of gross of think we for some thinking then how and us, net how sort you patent to efla, are housekeeping ones. about the about any Can pricing, adjustments? you just should

Thomas J. Riga

So so it North -- available XX there's us. that's the goes patent think XXs I efla is for where of some goes into are is the to that well that and extensions

of try do dosing, the And day saw So initial see will number we find of the have we think will initial and is phase answer think to is I that signal patients. long-term Cohort upon same product. dynamics that we trajectory of think if because not so made asset, in our certainly IP. launch help way we think this about a as be to the approval differentiating the ultimately could attribute the the clinical But the pricing the relatively intend we the think are a around small if there balance to see we asset, that's public, I -- develop that signal approval that public, that that in the And will of do strategy remains. the the we're fortunate. about we we and through lifecycle going expand and market, We

a the position So management lifecycle we will commercialize optimize very point that duration I this the us of the if near-term And expect, think then the in lifecycle specific of that we to non-inferiority out plan label have plan we both and put should be that with to a asset. at approved. gate is

Reni Benjamin

just discussions Got an update for? about you point off in and/or and thinking the course, how forward. going BD give question monetizing Can it, you're are a then efla and of kind funding ex-U.S. the in have to regarding okay. if how as interested the of or one, where don't again opportunity company both and And of Pozi opportunity Ed's kind bandwidth the of us you're for ongoing, another clarifying like regions not of

Thomas J. Riga

Yeah, so within fabric. our that's development, business

of the those a our I are active different it answer non-U.S. there's conversations as And ongoing territories, number licensing today. a So the in on relates I it's is always and company. to where But depending asset. think areas think of topic

with discussions the had assumption be there Poziotinib to have is development earlier had is, today, for our asked we States. rights of question about which to the an I has think So, outside an and think business focus the there Ed got absolutely I will for and United continue approval,

you look we efla, at less worldwide Japan. reminder, a have Korea, rights when China, think just as and I

is the difference. Japan So

rights have a We But don't efla It's to Pozi, conclusion for we it factor. growth we rights ex-U.S. the have with is as the the I dynamic brought is our in products world believe It's how don't terms different we with at different those very of how forward. are and to bring efla. look same interest market, that business business think an relates they're entirely as reimbursed. just to that in

territories non-U.S. our will be with Poziotinib. on development for focused assets efforts business So these

Reni Benjamin

and color luck the going obviously for much very forward. you Thank good Excellent.

Thomas J. Riga

Reni. it appreciate Always

Operator

Please BRS. stand Wood with your is for from next question The William question. by next

is open. Your line now

William Wood

you're that progression Mayank Hi, Riley congratulations that and this questions meeting, for and taking this the at quarter. is William on just Wood specifically Mamtani preparing our maybe what how Securities. ODAC the the by on they're topics nice on B. gets Appreciate We're for you that data had -- curious think data, you've the very how also key their the members? given you're on be bring up expecting might split you given And to committee reviewed granting dose the cautious FDA then accelerated commentary much approvals? maybe

Thomas J. Riga

it's preparation, so on a think because bit Yeah, spending I think we're I question, warranted. time your good I think of --

on real has we macro aware FDA the addressed we need, comments a addressed accelerated on the of real comments FDA, of of has Poziotinib the Poziotinib that that medical kind approvals. unmet kind believe accelerated need. medical of But FDA think I macro are environment that a unmet we approvals. environment But believe

largest effectiveness. a safety. its characterized the the have relates this I it today, of It's world database as think in in it's got mutated particular profile And been demonstrated well to cancer. we

spending look it such preparing we macro team your we So attention looking a well great to is but the forward here is taken, sure we so the to of that are make environment and gets this it and representing deserves. are that time deal that, point at the

William Wood

you've ESMO. that your And abstract was very coming you, Thank additionally, you've going additional to then at you're have helpful. mentioned -- that got

curious all? into get be Just expecting, might a then color be and what could we how if the if process, we at little on extra incorporated that approval might

Thomas J. Riga

that Francois data. and let think the I'll it. on don't has that approval the process, do to Cohort is This comment know But about data population. I with X its anything I ESMO

review, has which NDA our will the NDA. under is it been So filed, the of be topic

Francois but data speak in the this comment. as although to here will that be it it's you I it's about relates part of dataset. Francois, will process, not to that like topic, think would approval that interesting,

Francois J. Lebel

sure. Yeah,

So in a second mutation HERX shows The high common against that's ESMO XX exon data the worlds. correct. most activity

So was common and going ESMO NDA Pozi in said, when we're but, that discussion high Tom for not that's itself, has were to is But mutation. that of showcasing interested in activity. against at what just activity the you the as is be I of a subject mean, the various is in of NDA. have lot one there mutation who understanding particular investigators interest in not data that's to the

of the dosing. risk but the what little done ODAC and what have filing members drug don't expecting. you As subject question little is have specific to the number provided suspect ask know -- I high We or as The us, dosing. benefit for We about overall more of pointed ODAC you've we bit will obviously out will question. what on will preparing are on sure we are a think for the asked DID about different extensive data be the discussion, of FDA we QD, as a that

will also be very obviously, we for and we patient, let's in patients. suspect Pozi as a treatment needs it we position think it, would option and And monitored options, subject attractive present believe evolving landscape that carefully that good is certainly discussion. a the that we we're of face and So a

William Wood

you much. thank Excellent, very

answering there. I your our think it questions again. appreciate I'll leave I congratulations and

Thomas J. Riga

William. Thanks

Operator

question. the by stand Please for next

Our next with Fitzgerald. Agarwal question comes from Cantor Prakhar

Your line open. is now

Prakhar Agarwal

Congrats on and Nora. quarter Tom team. good Hi, and the morning, congrats,

been the manufacturing have question So first seems on [indiscernible]. It issues that is resolved.

on with is plus here. other for a or based to and commercialization future XX% from right this net pricing GCSF probably year-on-year, the Pricing will up on foreseeable in follow So players I a decline more and less have in continue declining now market. commentary freefall market

is then how in may pricing you follow what's this can keep it you. scenario maybe your strategy market, pricing stable? a a And there Pozi. on Thank on where So up evolve had and I

Thomas J. Riga

Nice you. with chat to Prakhar. hey Yeah,

that today's I we have So given our this and issue through Xk one on where gone price there's have not the that all comment would the particular is a but is final situation pathway. biosimilars XXX innovator product dynamic make

trying So reimbursement that to and inevitably, dynamics other. to with compete are their behavior they is the each of subject

operate in XX be an will to offering and opportunities market years a think that the will some bringing that way. asset to We advantages will and is the that more predictability. novel that to and we provides end have over will first advantageous stability user we distinct offer And the bit and we

within other behavior is inevitably makes because the we tied see each we need opportunity, whose but closely don't is with the one that to as very ultimately one that an Hope another. reimbursement tracking to as the that market are players of competing sense. enter we So

Prakhar Agarwal

No, Tom. Pozi. And on helpful, follow that's a up really

how confirmatory in Phase to your X patients X, now, many enrollment by need maybe right have you. sites or where enrollment you been the satisfy do what So on are of to focus date? FDAs Thank be percentage target substantial PDUFA Phase active enrolled on and

Thomas J. Riga

about Francois, to want you talk this.

Francois J. Lebel

sure as sites, but -- opening sites. it are again, time takes we're know, we open to Sure, long active you in a very I'm

open, I'm speak not directly going We today. to going have some give not today. to enrollment you numbers am to I site

as moving North internationally America. so as we in can as And well we're fast as

remember was can't of what? I second part the your question So

Prakhar Agarwal

you FDAs do to be need on on enrollment substantial…? Where

Francois J. Lebel

Right.

discussion, are us forward So active And we we're demonstrate achieve they we show know, agencies by single that to have to got PDUFA had years, be as information unequivocally can. be. as discussed that we And quite be and that that if to a will seriously the to is from we a the directly that that particular multifactorial achieve. agency and was that with probably number of not we able had true the company, to the threshold this on day, not we -- they want basis believe judgment, the a fast that there's would we the that as moving a of last a have commitment number as here we're very serious years, this that as program believe few you we over maybe taking there

Prakhar Agarwal

Francois. discussions lines what the you venturing, Pozi, Thank any worth earlier on had regulators updates you maybe any on And might have into lastly with for be required? it. on just Got moving plans

Thomas J. Riga

Yeah.

the for question. thanks So

see here the lot gaining indication. a initial therapeutic approval. could population. approach need, physicians the really for and need the this for be a what initial taking it need, beyond focus We have are We of and disciplined particular asset we options the unmet patients potentially But aspiration of to on

now, love positive here point, focus gaining to and what sure in mentioned, get ODAC of but we data, positive would And because the is need then Cohort program once well. the we believe medical our share advance make to as in we for right will company of November. in to So of other optimally advance the the our for that prepared development a nod you that we're efforts interesting to both meeting areas

Prakhar Agarwal

to my the looking Thanks next update. I'm questions. taking forward for

Thomas J. Riga

Appreciate it.

Operator

am would for conference the At this are more turn there time, no I like Tom I to now remarks. questions. back showing Riga to closing

Thomas J. Riga

in call your Spectrum. Thank questions all today's for your active your participation interest everybody and you, for and on

great feel additional a anytime. to have day. us If always you questions, contact as free Have

Operator

This concludes participating. conference call. for today's Thank you

disconnect. now may You

Spectrum Pharmaceuticals (SPPI) 11 Aug 222022 Q2 Earnings call transcript