SPPI - Earnings call transcript Q1 2019 | Spectrum Pharmaceuticals, Inc.

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Operator

Good afternoon ladies and gentlemen, and welcome to the Spectrum Pharmaceuticals First Quarter 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host Mr. of and President Relations. Vice Kapoor, Strategic Investor Planning Shiv

Shiv Kapoor

joining Thank for results Thanks. everyone. for conference us financial Good afternoon XXXX you today quarter Spectrum's call. first

Turgeon, our press of call the our a from our an a operations at Our CFO available by provide and our on clinical followed Francois update is www.sppirx.com. will development release and Lebel. Joe CMO, discussion financial our overview, start Kurt CEO President, and website Dr. from Gustafson

make financial in presented such materially performance forward-looking actual by include to call everyone the risks and statements performance to projections may statements. we implied of financial statements a that, in differ like Such to compliance will not of and Before the measures, any Today's in from press non-GAAP forward-looking information considered from with statements forward-looking as to which a should the we financial for GAAP. be I'd and statements get guarantees or cause inherent involve regarding will With upon not refer future undue and included results known uncertainties, results call them. or afternoon. hand of future also release. notice let started, substitute and me or isolation over necessarily expressed performance which should that unknown in uncertainties forward-looking the discussion this This major future today's and not These are notice emphasizes periods risks reliance be placed Joe.

Joe Turgeon

today a a sale into announced company. pharma pipeline bold immuno-oncology. QX we to significant quarter was and shift spec includes your and call, in just Thank the developments. oncology moves legacy Spectrum. for growing the our strategically with you the thank company your biopharmaceutical portfolio of expansion oncology into strong and on to from jumpstart our evolution of Shiv our you, We've made everybody a This company interest

our of and advance of also the the cornerstones Company. We late development our ROLONTIS, poziotinib stage to continue assets

clinical poziotinib the EGFR trial quarter front, announced the our of in trial. primary progress fourth cohort year. ZENITHXX of expect in in X early treated this we the On or results cohort the analysis was Full we enrollment made and January the significant previously

continue Regarding with meet the with plan we to have ROLONTIS, FDA near and discussions agency the productive the to term. in

We file, do hope approval. it are submission our optimal as our to forward as successful it's a being happen look the and deliberate thorough ready. it's and updating in soon We FDA to we

announced We to Now let with FIT me we today. immune for Interferon that deal purchase closed the stage the Therapeutics shift or two Focused to gene. deal the along early assets platform

of the of We are FIT developing on now therapies novel forefront class in a immuno-oncology.

I include which The complements favorable in assets. multiple our a organizations, Leukemia for late shareholders. Lymphoma finally It's areas and & science of because Society. collaboration is value through world-class UCLA, And deal a why vision, consistent It great serve and company. you liked products good you innovative commitment look When at our tell bring the value it's our how science, fits with this it vision several into needs sits with cancer. stage validated scientific is consistent as strategy. highly are the to UPMC with deal to it fit it me is Let our it and right terms it's unmet our the the great for our

over I'm our proud the company strategy say Dr. a shape, initial is help area, Overall to with growing deal also. studies. Our that, great is on pipeline. has strong results look the to more start walk from seeing that a forward Kurt considerable to a to and to I'm the Company off experience which you for in Francois to biopharmaceutical oncology the is will this a it team turn detail we're With XXXX platform. going the this taking and through financials. is for I products in and now going the

Kurt Gustafson

of The that will And before. a sold the what product our sale result X. representing Joe. financial between the GAAP, sale of Under are Thanks to our operations. and discontinued commercial than this look financial closed discontinued on bit If portfolio different Acrotech Acrotech. statements statements portion split was you've a continuing as operations operations to seen of the March business

to $XX the the all million regards face which discontinued operations. manner. for these historical substance. you'll are product of was financials of GAAP purchases With that R&D result, as $XX.X we missing are expense expense that the a sales report note SG&A periods in and Note includes items that first the reported of As cost as million sales our quarter off in drug $X and continuing operations, of our was same ROLONTIS XXXX million, requires

later our is until that As been sold sold of good zero R&D report as and inventory material that expensed. the have a given expense this for reminder, is was approved. When accounting practice we’ll this to facility previously cost material product

loss Pharmaceuticals. an an of We $XX.X due in income in other also had our interest million equity value unrealized the expense loss to in CASI

from total $XX.X million. loss operations was Our continuing

when total held the be operations million However, This of primarily is $XXX as basis, performance the of million close transaction, in are with cash. million due compensation the classified million. in certain was Acrotech restricted figure escrow the $X which our met. as amount is $XX.X that marketable even costs non-GAAP post-closing securities stock backs and an cash for part this a transaction represents in in to position obligations Included costs of or released a ended is loss out We $XXX related non-GAAP $XX on quarter from of cash million. stronger. severance certain and cash continuing Post

the cover expenditures the hand call of me update expect Regarding the XXXX. programs. the on that We were accepted. will plan the our to planned Francois to expectations, has clinical previous ROLONTIS launch over been once to to that, guidance, that be to delayed prelaunch given relative postpone with guidance certain file we And let for updates

Francois Lebel

going treatment insertion mutations XX start update Hello The on no really mutations providing development to and their have to are late-stage across by among program tumor physician poziotinib. regarding exon I'm currently investigating focused patients most These Exon the need pozi approved FDA of XX types. an is and asset, new targeted options. difficult treat Thanks everyone. therapies. Kurt. our the treatment

We are well multi-centric called ZENITHXX. underway trial with our pivotal

in As expect results the we mentioned, Joe year. primary X from cohort analysis of fourth this quarter the

called cohort HERX the cohort also Regarding treated X. previously

enrolled to enrollment patients options of previous has Poziotinib for are this for Our type very by with need is would that be these guidance and Currently, a limited patients. clear cancer. of well fully grim treatment and expectation. prognosis lung is was ahead QX we fill the potential very

cohorts are aggressively In addition therapy treated X poziotinib X to cohorts X, EGFR previously mutations. which patients, and both in we and in first-line insertion patient as and evaluating HERX with X XX are in exon enrolling

also evaluate in where and tumor other preclinical planning combination to we promising in Additionally, data. types poziotinib we're have

As come to of the previously start half more in future. this the so guided, are we looking to in year, this trial second

Regarding near-term. are refining our BLA and we in the ROLONTIS, file the with anticipating meeting FDA

trials ROLONTIS June. in data session have our a Phase integrated patients. with poster presented X total a will in These XXX in Additionally, to be from of been be Chicago at two ASCO data accepted

and integrated data independently X our of sharing We one ASCO. Phase primary each reported, at previously were met the studies endpoints. secondary look As to forward

very assets. is in the of welcome our to space FIT shift today's Now FIT This acquisition platform early Interferons for targeting to a are know validated and platform of monoclonal with new me potent a of two that addition as cytokines well form well. established therapy a fusing cancers. creates antibodies engineered let I class The stage pipeline tumor various the by biotherapeutics, antigens. are interferon that alpha immune

that historically including the potential with and FIT technology We agent in minimize to significant checkpoint with associated therapies single These potential systemic However, interferons side application maintain the have has other or therapies, inhibitors. rational effects. combination toxicity. been with novel dose-related as have the believe efficacy

The is lymphoma, CDXX exists. is can studied a whereby suggest candidate in lymphoma X non-Hodgkin In to molecule pathways an been fusion ability interferon essentially in has considerable results apoptosis. protein Phase significant anti-CDXX-interferon to induce large an have B preclinical improved development, unmet is This fusion relapsed/refractory cells. diffuse first the where this cell eradicate against tumor including need being medical and fusion a tumor directed shown drug still both models, asset CDXX. Preclinical signaling antibody that protein receptor two to alpha interferon anti-CDXX-interferon proapoptotic activated have alpha exhibiting therapeutic and while activity be pronged attack cell index,

asset targeting or malignancies GRPXX second an This treating protein. for demonstrated in heat-shock and antibody-interferon hematologic both The the has preclinical development. solid and potential fusion is is molecule asset

fusion as near-term, the protein this we the ongoing looks Our with dose possible. anti-GRPXX soon collaboration study an at of escalation the the forward In clinic clinical and UCLA, platform. CDXX team as complete to will the bring the discoverer directed of to

will on ROLONTIS milestone The new expands the but cornerstone the We asset FIT candidate. pipeline you nicely and update our remain and the early-stage Poziotinib with in of promising development future. platform portfolio.

Now I'd it to like Joe. turn to back

Joe Turgeon

clear the company to you, bold few has made shifts hope major strengthen move open And operator it make it's as to you like Thank moves forward. first continue And we see XXXX. to that that, Spectrum I Francois. the of questions. Dr. in some months we'll with I'd to up,

Operator

question of from Cantor Fitzgerald. Instructions] Alethia line Young comes [Operator from the First

line Your is now open.

Unidentified Analyst

cash just specifically pipeline have the you in current today's On was what for what bring the looking still to on might attractive or this ideal those your versus And curious, Emma you and I-O acquisition, Alethia. of market additional balance, be? opportunity assets just looked for others profile an and looking is the at? platform at in would then This you guess were any about are I

Joe Turgeon

and start get Dr. to I'll also involved. I'm Yes, Francois let going

fits looking that our have we have need unmet first synergistic would where we're going we FIT, We for I Things have road of that the drugs commercially obviously. to forward validated move the it as in to we is, what science, as in for expertise look with the cancer. think in are medical we are down fit That's the and at. look oncology – We it hematology. want And thing want and the past. we're are fit vision.

like. in So we're if And looking for Dr. that's your you Francois, perspective oncology. basically what let add you'd from I'll

Francois Lebel

forward lot I've of oncology. to Right, we it's highlighted I know, way you. for matter. a our and have that experience CAR in unique are of a the had we attractive was cytokine get a validated And a a a sense where past as therapy number happen of company, on that to hands made Immuno-oncology, of kind including the price. a the with worked you the is as assets for well at very But just this targeting myself, to think lot chance was target in where opportunity Joe

pass. not it was could a opportunity So unique that we

Joe Turgeon

immuno-oncology. area about asked you That's Sure. it. think interesting a glad in We're now. to I be really right

Unidentified Analyst

then think And as potential that’s any neither for? just you about acquisitions, still appetite like future

Joe Turgeon

the question. I didn't your repeat end the Could hear end? sorry. I'm of you

Unidentified Analyst

Sure.

at following what this the cash bring acquisition now. today? market still looking Just your Are in and balance was in announced additional assets beyond to you

Kurt Gustafson

Our business products. to acquire new model is

with consistent mission is have this and the So vision we that here.

were and continue build always portfolio. to we hope look to on So the this

Unidentified Analyst

Thanks so much.

Joe Turgeon

you. Thank

Operator

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

Your line is now open.

Ed White

my for taking guys. questions. Hi Thanks

Joe Turgeon

Ed. Hi,

Ed White

of neutropenia First It of patients. from the like years ASCO was chemotherapy-induced ASCO, seem change seems previous on all didn't it interested when it's congratulations. in like – a treatment

again obviously So area in and that. with I’ll to – launch? the you think there's for way though, then what the back on seeing well, another medical you're therapies question also new that excitement do as ROLONTIS, more ROLONTIS come from And community all after in now some your you the prepare this behind

Joe Turgeon

Tom I comment and Yes, too. there's then can excitement. think do I’ll start that

and so opposites for so this, this coming years was come it what beginning. us that, of the part And the big more one-stop the game, out, novel think I changing that's and now to unique only years speak. I I and these time. right new even all as in we’re is years first in is only think since know, products was shopping, as therapeutic speak makes And a place, you For one that to the

biosimilar are position. a unique had others us The very so put in

ASCO ASCO we're the in that about good So excited that. yes, trials see accepted it the integration too of poster, you'll get because both to and was

Tom, they trials. these right, the accept and combine comment And you you you're to let see data poster So did two also. the I'll get

Tom Riga

Ed, Tom. Hey, it’s

a and interest, especially year supportive always are the markets large has to will important into competition several. had oncologists brings think attention that continue in over and I of really the care lot next past

agency be achieve approval. back to excited it, we're a So this of part get to file and ultimately the

Ed White

thinking delayed something launches in reading you mean, this? about XXXX a still occur I on ROLONTIS going had just to that XXXX. then the prelaunch the And you are possibility? being much I in postponing is are do that Am into Tom. said Thanks, think Okay. now Kurt too XXXX or into expectations

Joe Turgeon

comment remind better position we're You agency until know got meeting Ed, which when I we’ll think don’t an I on in want a you want. upcoming with told we're module, they to helpful. with us we've I'll diligently to that the at. prepare be to where you, – very C&C see the working they I'll remind this, They're us the working exactly what being the

near-term, look It that I we're And well you of clinical really – was as making I'm part was meeting. that of thing. with to plan progress forward the as we'll you, So the the the ready. it's hardest the both argue next know on the endpoints, I'll know, file. And meeting filing soon data primary the on secondary after sound. as pleased the remind when. with it and the agency, in could is And we more about which part then you that again,

I your So hope that answers question.

Ed White

in was does enhancement, No, if Thanks. to there's for Yes. I’m presentations so submitted just be as – it I abstracts or And was – either at Heymach pozi assuming nothing ASCO, Spectrum just the abstract or by but or going I no again ASCO, curious that I'm Dr. was on an on poziotinib? just if curious there expect Joe.

Joe Turgeon

cohort I’m nothing you in quarter our know No, the X. be fourth data was not – submitted. from that will

Ed White

know too, you enrollment you tell us Okay. you that? there? that within of X, the really give just us I last just, can vein progress can that then anything happening X appreciate. timeline in or a didn't Thank question, cohorts for give but And how on expectations you. I’d Is or is

Francois Lebel

the you question. Thank Yes. for

track recruitment we're of So recruiting. dose. We're for yes, on the

of number Europe opening the near-term. have in We site in additional

which accelerate. we even things potentially recruitment the that said you and cohort So we're we though be will we track think going is I particularly is we're QX guiding think that there. even today, is important on think even And well more will X new event,

tuned. stay So

Joe Turgeon

I'll Ed, ahead need cohort tells Dr. cohort now, unmet It question. add at look for X demonstrates of need schedule. thing. one When There's Francois here. these schedule, of X just you ahead certainly patients, you no a the

Ed White

expecting get an you I like, it's update Okay, become said with ROLONTIS great. Joe. the until, Thanks until I us it XXXX. give And more investors? FDA XX. launch actually, I will clarity, as you'll that But to before, wasn't that seems We you more mistakenly students be once or like think misspoke some meet you that clear. after you conveying

Joe Turgeon

said this going is upcoming what as file we that's we the as we're to now tell what it's as ready, in, you I get I meeting, am got right Well, soon to that do. want to going

Ed White

Okay, enough. good Joe. Thanks

Joe Turgeon

Thank you. Ed.

Operator

the line Raycroft next Your from question comes Jefferies. of from Maury

is now open. line Your

Maury Raycroft

my taking for thanks and afternoon good questions. Hi,

one First on poziotinib is cohort just X. on

at then? think the well. may point than earlier that a expected come like for pretty where So is data you Are it the going sounds enrollment you

Francois Lebel

guidance not things along telling full are officially for we're just changed moving you here, it's still the that Now enrollment. QX nicely. very we've But

We We the the durable to only terms have not sure that in follow of make patient would have last patient following changed but anything in we to response. have response not data.

So that there's front. change on no

Joe Turgeon

cohorts four standalone. you of thing I More other the I remind the are that each is and individually will, will on powered

So, I'll that. remind you

Maury Raycroft

then the Interferon CDXX interesting. It. Thank Got And you. pretty it's acquisition,

and patients can status at a And give many I'm therapeutically on are right and active update you trial dose? so a enrolling that X Phase that that now, are in how you

Francois Lebel

cohorts. is much is other can been to and announce escalation many of parameters. cohorts thing expected cohorts if we say that looking number and I dosed a right go the there's obviously you cohorts maximum right so that, tolerated was as traditional you good better in likely now only was how what’s is see safety much do by to than you're to a in-line dose There we're of three of be more this of progress number meaning there going a will profile in need And a terms have for but and, very we so clinicaltrials.gov The not very dose the study. need. with few terms three not, have interferon. as the we'll Yes, now anything Obviously many

So the going results. eventually to we're not scientific appropriate resolve to we forum today more as any give or detail. patients any an Obviously number present of in will

Maury Raycroft

Got it.

more IgG details that. even if there's the about about can unique targeting, if the Okay. the I'm about epitope wondering asking some molecule, you And or something CDXX that say that just could on. you format around anything it's comment then

Joe Turgeon

that got as we the I or, don't what proprietary moiety technology to through from a we any epitopes disclose modification which detail disclosed think UCLA. and have were or we have So, that to we the on fragment believe the or on either. license planning And interferon done antibody

Maury Raycroft

Okay. then, there I'm in platform. exactly. could more And is antibody about wondering the also that delivery talk a if in the just what line FIT was update And you about

Francois Lebel

Well, it's a a or have platform. in flexible deliver there, comments I it, double there my the It mentioned attractive possibility . to as hit very you

that potentially to the signature. of You'd gene interferon leads get the induced expression an the interferon, activity

that, to without truly say benefit data toxicity. might far the data you systemic was the that lack you problem the know, interferon of an past, interferon as in here the the as benefit. the get a a encouraging the And let's is molecule. of clinical preclinical very the has with there toxicity, so And get anti-tumor necessarily activity And just toxicity. not that so be as as the well been way It

it. encouraging that's very aspect and one So, that's of only

where tumor is to the antigen, You the the to right be quantity you higher microenvironment site other the of tumor action molecule, to brings want targeting parts interferon the if needed a want. delivered a of that's to of and the interferon which

So you've a double got you want. whammy if

activity and the circulation micro-environment concentrated activity, the at this where need you in interferon the You tumor get systemic it. benefit, in minimal site

Maury Raycroft

Yes. interesting. Cool. pretty It's

the And and microenvironment. so you're much getting interferon you're less the into tumor using basically interferon

Francois Lebel

flavor been XX you interferon target possibly come what targeting excess also - following plus, or various, GRPXX. you is we're as though in the know, subtypes, remember other that Absolutely, current one alpha the to here be one possible antibody CDXX, we've And the of But is subtypes. can here. interferons the access in will example has for in probably licensed

flexibility lot have So, with this we of a platform.

Maury Raycroft

it. Got

Okay. much. very Thank you

Joe Turgeon

Thanks, questions like to Maury. time. I'm I Joe to Turgeon. the showing no this would back further now conference at turn

Joe Turgeon

I future. interest. the to you for Thank operator. to and appreciate the forward Thank I much, talking everybody's joining call very you in you look

Operator

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

You disconnect. may all

Spectrum Pharmaceuticals (SPPI) 9 May 192019 Q1 Earnings call transcript