SPPI - Earnings call transcript Q4 2018 | Spectrum Pharmaceuticals, Inc.

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Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Spectrum Pharmaceuticals Fourth Quarter 2018 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 will be recorded. to conference like to now would turn over the Mr. I Planning Vice Relations. President Kapoor, and of Shiv Strategic Investor Sir, you may begin.

Shiv Kapoor

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

development results Kurt our of by Our at from Turgeon, These from a operations will the financial www.sppirx.com. President, undue not our differ materially provide future any should and CFO website call and press update and With and forward-looking available guarantees unknown by today Dr. periods CEO projections Gustafson them. an Such CMO, Joe from discussion Francois risks me is or statements. are performance start to release statements forward-looking clinical and of of implied on a statements our that, performance overview, financial future Joe. necessarily our the uncertainties our or followed which reliance Lebel. let actual results not hand in placed known over such cause expressed and be to involve may future on and call performance

Joseph Turgeon

significant development strengthened data both and and was poziotinib proud really poziotinib confidence and as Thank that rich the very are interest XXXX I and The defines appreciate year first was in in these of XXXX and XXXX year major everybody Good assets. data both very a hello most reflect the year there advancement my CEO we Spectrum the the ROLONTIS for I'm and was your in call. on of Spectrum. pipeline for full afternoon, you, in on of who three developments Shiv. I productive to the XXXX ROLONTIS. as assets, are our our today.

These mutations the tumor from mutations cancer. exon data patients with poziotinib non-small most Phase treat types initial study across insertion of In activity. FDA investigating XX HERX cell program, targeted anti-tumor focus lung are X lung no impressive difficult and currently treatment the to mutations among approved in in On an XX MD the non-small demonstrated exon therapies. XXXX the are or have cancer EGFR cell Anderson's we with

in are our fourth in enrollment primary EGFR cancer We in exon EGFR Full non-small cohort and and quarter of treated line first results patients and poziotinib with that underway XX lung of treated the insertion cell announced with pivotal previously previously expect we in trial of currently both well year. was the early January HERX the analysis this mutations.

two with was from standard demonstrated FDA non-inferior safety with December of it in the file received submitted profile. a January the officially was Phase trials XX, the For X XXXX. that to on the BLA ROLONTIS government late shutdown Due and care data a XXXX. similar We

about shutdown the month. the sense has in government So process that a by delayed

second a focused development knew of early XXXX The company on pharma tenure a move to We spec major targeted interests in my from was change treatments it novel was in in as to shift needs. biopharma position. major the strategy. our best by shareholders' proceeds bringing company laser medical business our will sale unmet The a in legacy strengthen sale high patients to recent our significantly products The generated to novel of on was strategic development. that drug areas financial of oncology focus ensure

realization for the the the The for used ROLONTIS. $XXX will primarily legacy of payment prelaunch of upfront cash the million efforts have of those of flow the cash products. cast activities we poziotinib With significantly accelerated development and be

directions. longer cancer asset out-license point, our business our the as company function. it fits the on streamline to our in strategic we At we drivers, value late as QAPZOLA and development program development focus stage have we're the through no this Additionally, discontinued looking bladder

while development we're and drastic of opportunities growth joined the corporate has us Francois focus poziotinib November our our XXXX, evaluate And at The of the in crucial Officer beyond provided look the existing opportunities. pipeline. clinical Chief team role refining our and our we executive team the allows XXXX of bolstering As also third played ROLONTIS to Dr. assets governance. funds Medical the sale a major strengthening was our in in exploring our primary Lebel legacy addition a and since final approach. and additional be by will and

XXXX majority Regarding in poison enthusiastic to we board made XXXX voting as we experience we start. proxy great very with members are that the In progress accomplished is governance, and corporate very the enabled pill, all tremendous added needed advanced and off a eliminated and access appropriate business. our already

about with that, talk the Now financials. turn to Kurt over it to let me

Kurt Gustafson

Thank you, Joe.

So had fourth solid a with sales. the starting we total million topline, revenues with which quarter $XX.X million of were quarter of the for $XX product

$XXX associated third were our expenses divestiture was which for fourth million. mostly the at our $XX.X driven For $XXX to million million SG&A legal end commercial the R&D higher the previous year, is $XX.X the quarter. were million up $XX.X $XX.X assets. in up most $XX.X by the million expense expenses with were revenue. $XXX.X quarter total for quarter, million costs for of from million year of the of revenue total SG&A million the from recent guidance the quarter, top of in

the all by to expenses to we've stated in we ROLONTIS. past, As two going is related of prepare increase commercialization driven are The further develop ramp the assets and as fourth the the quarter up factors ROLONTIS. R&D in for

we million First, to ROLONTIS FDA for $X.X BLA deal. the paid filing the

to Second, build the inventory. spent $XX.X in fourth quarter million we pre-commercial

has we inventory. accounting to generally this expense context until some cost accepted of as this to facility principles you by zero practice are approved inventory as When product we give this goods. will product inventory been the me FDA. sold, and accounting our is required Under it relates report later our the about Let this

supply year purchase R&D both the full and ROLONTIS expenditures, million liquidity. $XX.X to in for quarter Of $XXX.X in a marketable for million $XX.X million the and cash million was total million. the $X.X clinical burn year cash $XX $XX R&D with the ended year Moving We was $XX.X poziotinib. expenses, burn $XXX expenses of and pre-commercial with the million. for of Cash R&D was of securities were million this million total year available and of

assets of deal to we divestiture and in our from the March. the Regarding clearance close have commercial to expect Acrotech the SEC we

decrease As we closes to XXXX the SG&A to assuming expect approximately relative costs deal look March, XX% ahead by XXXX, XXXX. in we to

on normally and transfer it be to activities costs for legacy supply and as spend R&D year is spending expect on assets than was last increased lower higher offset pre-commercial tech by ROLONTIS poziotinib. both the We

of me sale of assets, the will Francois operations at to balance commercial hand from call over sufficient years. the updates our program. our our that we for be expect increase With three to With cover the let now cash the that, clinical cash run to least on

Francois Lebel

everyone. Hello Kurt. Thanks

momentum. to that we program responses, and of spoken for the with Regarding us takes in for release ended otinib in that previously very able The the announced important in year. of has is great our patient Joe trial being strongly weeks and is if six the XXXX start about we program confirm Spectrum. enrolled last this to [ph] BLA The filing close we months January QX future forward. to In cohort milestone XXXX early and patients moving least the EGFR development our clinical already ROLONTIS. This a aggressively eight enrolled. follow [ph] topline treated we of is January assess fully durability data for at assume pivotal was clinical to

provide meant you cohort submission. very to remind the data it's important because is this that the poziotinib NDA first me required for Let

insertion to be previously We also recently expected XX announced cell treated fully patients is is HERX cohort Cohort with enrolled that two lung exon QX. by the second cancer non-small mutations. evaluating

poziotinib first mutation. the line treatment to cohorts two continue we same in as evaluating Additionally, enroll the

reminder, cohort in a hypothesis study As and pre-specified trial an power. the ZENITHXX is with statistical each considered independent

non-small line poziotinib Beyond to need. previously are areas two cancer, we planning in treated evaluate cell unmet lung and of other first

setting the seen not First, basket several in pan-tumor This lung mutation cancer, non-small only tumors cell study. has a solid but been has other been types. in with reported

non with also XX cell small studies we insertion exon mutations. planning Second, are in combination

on We in to second the start more half so the are to of that. looking these come trials year,

enthusiastic could more few reflect Spectrum, As I future. be on at I months my first our about not

BLA gives market our us an suffering with ongoing a the this unmet have I pivotal we poziotinib of medical long-acting exciting show opportunity patients to from a later antitumor filed population to in neutropenia patient in activity for to the bring area need. impressive GCSM which study an a treat program cancer hard Poziotinib novel results have development sharing from forward and We year. chemotherapy look has and to induced

updated will throughout on the XXXX clinical is milestones excited keeping focused team be and year. the you Our and I development

back it Joe. to turn I'll Now,

Joseph Turgeon

the open to operator, Thank you, questions. like With Francois. that for I'd lines

Operator

[Operator Fitzgerald. first Young, Instructions] of comes question line Our Alethia Cantor the from

Your line is open.

Unidentified Analyst

on Anna Alethia. for Hi, is this

powered For the on you XX cancer all decisions? and frame help based prior FDA can the lung is for us the uses instead exon population cohort as comers studies on X ZENITHXX, that comparator the the or breakthrough that whether trial

Joseph Turgeon

question. good Alethia, So

different. different we we're those had the question this bit love cannot in of know need only that the We've and disclose And way you of to to breakthrough when agreement totally meet. frequently thing discussions understand approval would can a you this some we you're share but I there, and was get is As to we understanding when think our referring but for And to know tell we meet. a back is on little is today. well you quite need bar that the get we very FDA I an it designation actually we with with the and parameters parameters full statistical to the unfortunately discussions, I is

Unidentified Analyst

commercial then can color the efforts? And give us on specific just any you on Okay. ROLONTIS, rollout

Joseph Turgeon

Yes.

commercial First of prior a that will you always all do launch. build to out

get our we well PDUFA start timing. when So we the can date,

start we at our a launch. will probably months few expand a force anticipate sales We to before

key we did However, to stress experience in we want were in-line in some personnel key the we that products, with this and sold when part keep able our, keep field. the of to deal we leaders I

are So the need. to our training, still is to plan effectively et to the core this what and we to here right cetera, of is expand the force people and hire preparing team launch the already sales

the I'm do last stated, launches, products, thing supply when commercial to the we we've of I in you stated, as many, short purchase some want already started Kurt launch. do is because thing As to want you run many to involved last

the time launch we'll we're and We're this product. to be excited. ready ready So right getting at

Unidentified Analyst

you. Thank

Joseph Turgeon

Thank you.

Operator

from Guggenheim comes Butt question next Our line from of the Adnan Securities.

Your line is open.

Adnan Butt

and wanted ask if data that expect congrats has to strengthening for study seemed Joe, to the progressed year and balance HERX the the updated Do that enrollment be sheet on MD you when? it cohort thanks in Anderson October. I position. Hey since so this

Joseph Turgeon

we so what I'm XX%, I'm our has Twelve on saw, remind that. ORR patients HERX, of how Yes. with the at in the so now you, [ph] final first not of about were that line for saw say firstly cohort, those right be to Adnan trial. a Hey and was mentioned The sure Heymach on the Adnan, patients way EGFR that at the aware I number exactly XX first us By was reason in that data Dr. MD HERX, now I'll side. human moved lung. important we in in he's were will that and site Anderson. is two many data it was confirmed things the was valuable the HERX

with patients a sure of some when of around do plan is question, that you however that when. other tell update major his the on I you enrolled, I journal. can't exactly an next part will in the I'm kind be. publication fully So, along not when your the EGFR know medical do HERX, will was to announce,

Adnan Butt

year? say if that's you Can this

Joseph Turgeon

don't about don't John be talk and this to but you of to is is when I think I year, that be know the would I know at submitting that he don't year. want Francois? it'll who the he beginning have I if will to. submitting add to to

Francois Lebel

before he that happen have the but end not is be obviously met summit will and year, intention of the to recently able much, John certainly the scientific the whether would or some to venue as but appropriate John I one Not who something tell had with Yes. you.

Adnan Butt

study, sort Are as you cohort guiding unmet enroll ZENITH should Okay would the I one you difference first, which quickly that the on why cadence frontline for studies enroll in the need imagine given of as well. would know to then enrollment?

Joseph Turgeon

and which guiding you are to fully obviously second we've different. so, well be X we X first Yes, line. will enrolled not the is that's and and X at X cadence of be would prognosticate indicated enrolled And cohort is that the the this cohort one it Cohort would know by first is too point the expected we tell this finish don't we can't end to point. this and be at really year. early which

Adnan Butt

Kurt, cash approvals through ROLONTIS? maybe Kurt. and does guidance And your of launches for potential that poziotinib incorporate and

Kurt Gustafson

question Yes, Adnan. great

a I our and data as So ROLONTIS the forecast filing. at think we look about we take the great feel BLA

a guidance. does is XXXX So include so our that that in launch sometime of forecast that in indeed included and ROLONTIS

Adnan Butt

thanks. Okay,

Joseph Turgeon

Adnan. Thanks

Operator

[Operator Wainwright. from Instructions] HC Ed line of White Our next question the comes from

Your line is open.

Ed White

question. Thanks guys. Hi taking for my

So just milestone to I the $XXX guidance payments deal? to and potential burn want that include the million Kurt cash from go does back about in the milestone,

Kurt Gustafson

sort so, business activity the include way those don't So at that are at this point look of new any milestones this Ed we is, and forecast we development in uncertain.

that of part they not So be would forecast.

we balance and that to it, it through receive next certainly existing the our and three us taking takes we expect cash forecast on years. just rolled I'm based to roll that the, of out XXX Acrotech plus from we So the cash

Ed White

timelines Okay And the we've going talked the can us if great, Japan. about you the thanks expected and on EU for update then timelines forward wondering pozi was the I Kurt. U.S. just in for

another before you know patients and address. U.S. EU from has address to to You mentioned more the that potential the patients has Japan have X,XXX

and thoughts in curious just a for Europe I'm to Japan? of submission So any as timeline

Kurt Gustafson

Yes.

certainly Europe so X cohort So you over, process were working to like first we mentioning globally is you idea we cohorts get the open XX we through open, can of where over sites have gives in you of and the X/X all on, with Japan. were that have and X various in I going. are regulatory we to are engaging we're activities regulators don't, this time, it about tell of process and I opening actively think an I in more at but

Ed White

as the the if and wondering potential last. Okay. what yet I'm lastly, you started I'm and there, had just up wanted a going, started it discussion, payers anything - see gives can you if us ROLONTIS, with biosimilars to on on on launch that? especially the discussion are as share you the biosimilars I you that And that you mentioned or are how and towards with leg curious then payers just should that to has working if yet, how just actually you expected give the to talking is thinking

Thomas Riga

Tom. Hey it’s

comments function a throughout and have, We as core of a have build do here kept we've commercial the mentioned we've the we systematic our in out year.

reduction build So if commercial we SG&A go back to the Kurt’s guidance including that throughout XXXX. on in out XX% is

that and first getting payers with into of line market our it looks a the that of the of sight One of and look be engaged that we're areas is impact clear like we'll what very the dynamic to just have that we're of into monitoring closely. first the biosimilars

plan and the in sit are of are good we our where about execution today. we our So feeling throes of full really

Kurt Gustafson

reminding we are which and things, to you add and everybody I'll number unique us in novel a puts one, position. two Ed, Yes that that

important people that Every talked in of. know, the secondly, remind we as the when to biosimilars to three had launched. past. I've our just you of two all modeling think and that's model and on this about And market I we in

So remind didn't that. anticipate, this for just is you or we nothing so didn't that plan I'll

Ed White

Thanks Kurt. taking Okay great, my questions. for

Joseph Turgeon

Thanks, Ed.

Operator

to like back turn Joe question-and-answer portion would to Turgeon of the the the I now ends call. This conference

Joseph Turgeon

Thank the for I to In ROLONTIS you, foundation Have the ahead. Spectrum's your and building Thank know poziotinib and day and future operator. everybody. questions are about and solid great you. interest we're everybody year new participation directions a want Thank we're a XXXX you you our today. cornerstones. enthusiastic for your and

Operator

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

all disconnect. You may

Shiv Kapoor	Vice President of Strategic Planning and Investor Relations
Kurt Gustafson	Executive Vice President, Chief Financial Officer and Principal Accounting Officer
Joseph Turgeon	President and Chief Executive Officer
Francois Lebel	Chief Medical Officer
Thomas Riga	Chief Operating Officer
Alethia Young	Cantor Fitzgerald
Adnan Butt	Guggenheim Securities
Ed White	HC Wainwright

Spectrum Pharmaceuticals (SPPI) 28 Feb 192018 Q4 Earnings call transcript