SPPI - Earnings call transcript Q1 2022 | Spectrum Pharmaceuticals, Inc.

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Operator

Thank you for standing by. And welcome to the Spectrum Pharmaceuticals First Quarter 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] I would now like to hand the conference over to Mr. President Strategy Vice Operations. Senior Grabow, of and Corporate Michael Please go ahead.

Michael Grabow

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

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

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

statements eflapegrastim, our successfully assets. we today’s our burn continued started, gaining stage of and year you for Riga I inherent statements. products. Forward-Looking would ensuring such unknown known off our late the this Two, like release. performance Spectrum. the are the approvals reference are Riga, performance of afternoon core emphasizes objectives, one, the regarding and in assets and call statements business strong forward-looking necessarily or to in cause future quarter, that active late actual both Good risks both agency. FDA start and and thank projections expressed get our to three, under prepared be a involve uncertainties, the to over Statements by we company and let Tom this today. notice The financial may our materially to or major FDA placed risks In advancing anticipate for later included approvals CEO forward-looking results on in not are undue will me future we statements us further differ guarantees future press forward-looking review is which hand With joining and first performance results notice and should that, Thomas to This periods reliance make call them. to Before optimizing uncertainties year and which as These streamlining any on of make from afternoon. Such with on Poziotinib launch we we the stage not implied cash progress the and are two

Poziotinib. provide starting me some Let highlights with

is XXXX. NDA under date review, the XX, of PDUFA agency has November Our set active and a

indication the treatment non-small the lung HERX previously exon cancer are is application. study designation, for currently and confirmatory treated or our With this first In we of and in treatments approved insertion product fast the patients indication. an the This advanced quarter, of initiated a for locally is approval support track process. with step in cell XX important initial no mutations. This there metastatic, a required harboring global

Additionally, space. frontline cohort is the we positive exon successful in which second HERX AACR XX presented their our meeting, insertion at data mutation

that review Poziotinib today in in the the plans ODAC FDA with of announced we meeting to Finally, its connection host NDA.

XXnd look meeting meeting preparing in are and previously unmet play for XXrd. can mutations. We the Poziotinib advisory opportunity medical the ODAC XX fall insertion forward September addressing important of HERX in The scheduled the and to to need that exon patients is with treated for treatment highlight this role an

when the Poziotinib We share it the will and specific for time available. discussion date becomes

is therapy Now, to a in me assigned September PDUFA and date the to resubmitted our forward quarter, XXXX. BLA X, this novel let the bringing FDA eflapegrastim. accepted shift This of significant In patients. a step

of high. we market Hanmi efforts Furthermore, to and remains substance partner prepare to the pre-approval facility. have the commercial actively this are We working inspection our enter kicked readiness off our drug for enthusiasm upcoming with our

the long-acting trajectory, optimize are and substantial to remains approved. market and is to if Our commercial yet leadership in we infrastructure The to G-CSF payers to looking key we the compete. and customers engage ready through organizations a third-party place forward market purchasing launch competitive ensure opportunity

plans closer commercial detailed to our launch. move we We will as share

Moving of to those January, and results our to be the success. seen The in we our continue can of evaluate our ways operations, initial strategic financials. our future streamline cash restructure in efforts optimize We QX operations. organization our and to burn while began the investing in

to our partnership stronger with Board Strategy Lim relationship as on an of Pharmaceutical. Global she has strengthened of $XX been Ms. agreements and the stage than equity been serves and from licensing is have they the flows Directors partnership their having allow Juhyun and dynamics Welcome Hanmi and our Lim us in Juhyun critically a with and research as today. Ms. strong Hanmi important Pharmaceutical. the an first in amendments The Hanmi maximize included our cost are million and never late by also to President of engine. to amendments and Spectrum will exceptional to partnership, our impact We near-term our partnership essence Planning Hanmi cash to stem This our provide advocate supply both Hanmi is A for board. poziotinib goods. for immediate currently Spectrum to The improvements investment eflapegrastim. our quarter.

that announced serves sector, M&A, audit investment will financial currently as banking, officer of the chair in also as She chief of and joined Bradrick quarter. second Neurelis. the serve XX-years finance, with including strategy of experience has the a development. Board life Ms. Bradrick executive at last corporate our we week Additionally, seasoned Ms. our as Brittany sciences and is Directors

officially Ms. as appointment XXth. senior of Nora to CFO on running the Spectrum. yesterday Just Board as welcome the team company. the will been she the company company of Her I’m we the new audit chair serving knowledge and Nora on Nora new our to thrilled ground and has announced as join to leadership and intimate the to Directors May hit familiarity team the her her Brennan in role. with allow the the of will

for an million XXXX. is compared our related the the XX.X would to quarter. review were reversal a comparable the favorability XX.X accrual XXXX We or this, securities, million per in compared quarter substance XX.X driven $X.XX On non-GAAP million net the compared to the net million with at XX.X restructuring. December longer $X.XX or to research million period of the XXX.X X.X X.X financials our the same SG&A of in non-GAAP per development no loss Total that $XX.X the share, plus to was approximately to expenses share compared million of for XXXX, of in Given payable was basis, X.X I Pharmaceuticals. loss drug share or or quarter million period primarily per $X.XX comparable XX.X loss in Hanmi the share, cash a XXXX. for of million XX.X and in net the quarter, to like XX marketable by net first to same of million eflapegrastim in to per million first period ended as quarter period recent XXXX. The compared The $X.XX in XXXX. noncash loss the of expenses million were was in

As previously reported, in balance. million, we investment received the of is Hanmi equity in a included ending from January which strategic $XX

detailed runway with in to burn now I political operating will restructuring due January approximately XX.X Our to will Lebel the million over period Company’s restructuring million announced more was the that, progress. update on turn cash development was to prior cash XX.X onetime into Dr. in our for combined the and call as costs to the extend elevated With a XXXX. compared

Francois Lebel

non need. an Study XX or weeks. previously a HERX with now six based the are call cell exon positive Poziotinib following X-milligram in pleased Patients to confirmatory study XX BID multicenter great The of fail six advancing PINNACLE Posey market the X being XX I’m harboring this under report review is XXX enroll The latest already mutation our the We exon global potential lung every insertion be designed be patients and everyone. of on non Poziotinib this is docetaxel to at on mutation urgency glad into initiated cancer afternoon, three with indication, the versus be have metastatic data with with NDA patients great you previously. week of has mutation. evaluated and to active supporting on treated harboring receive for FDA to locally discussion major specific September. We today’s meter patients administered HERX weeks to is R&D of at operated IV lung randomized of are and ZENITHXX This is one to cancer. our for treatment exon toward ODAC team from small filing clinical is small trial, the unmet sense believe with square Good advanced which randomized small cell first preparing Patient will a area achievements. FDA Cohort every currently with actively the per HERX SPI-POZ-XXX The medical two a in for of or review lung FDA. cancer, and meeting cell thereafter. with consisted to XX-milligrams study administered step

progression study. will objective control clinical Dr. survival day Separately, to the XX objectives. ZENITHXX duration and by allowed cohorts Pozi arm validate poziotinib. would demonstrated secondary the response Following will and British a response, cross Cohorot rate, docetaxel with presented in primary evaluate overall total the into per be over by the Center. at rate first patient be recently included that more has will Pozi who to the of I endpoint XX free on receive progression positive will patients, rate This as survival, at like of disease to highlight hazard is from of TAT conducted line were achieved data PFS and be safety results from for log an of superior power the rank two that using of X.XX committee analysis Columbia pro hypothesis X are equal a Sun or oral a XX% test. of test monitoring the now docetaxel by size study milligram Congress two independent ratio provide positive a than ESMO patients that used Cancer A March the to the smaller futility This Pozi to sided of data design the

using endpoint the by The the met X-milligram with primary and related And including paronychia out an with the then the at valuable drug X no XX%, patients stomatitis, XX received ORR cohort consistent ORR of in safety events evaluated one of higher than criteria. resist patients response. complete or grade new with common. profile expected, with higher X% rash, notably were on XX Treatment dose. class, most events being were incidence primary patient as the seven patients adverse committee Pozi of an was low independent be pneumonitis BID image X.X review XX once death. these patient endpoint less XX% or XX continue first to a frontline Grade adverse The milligrams reduced additional of or of target centrally with daily, and ORR two was receive an related diarrhea three TKI BID,

presentation that insertion shift cell Preliminary let non exon Now, DNA weeks meeting me to in during mutation a plasma circulating results response with cancer. XX patients small in a decrease therapy in recent with AACR suggest correlate Pozi tumor ago. New clinical in lung at few HERX Orleans the

accepted correlation between ctDNA a ASCO Additional this study the will so a data new therapeutic, treatment and response meeting These June. clinical evidence observation from stay data been decline for longer and tuned. annual upcoming a presentation a provide further with in to at Pozi cover has of

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

call would concludes like achieve I you keep remarks. questions. as to will for That prepared key additional milestones. We our posted the And we open prime Operator.

Operator

question [Operator Raycroft Maury you first from Our Jefferies. with Thank Instructions] comes

open. line is now Your

Maury Raycroft

on Hi I the thanks Congrats will my with taking for questions. the off and III Phase everyone. progress program. start

in talk date that if view how about November? can you be Just for confident enrolled that group you can docetaxel for the the PDUFA your substantially are wondering and by you in bar

Thomas Riga

to about pleasure talk this. Sure,

definitely It extent the But obviously, quite to the literature and establishing that is beyond the confident now no we was, not given recall study, know, solid right prior there was I control I’m I’m superiority in that. have or go number beat not believe. the I know, question, you going a less. to there that. need. further order The I that going be the, that. you So of think docetaxel. we to There true study. And PFS, parameters you. patients another of months not your are you medical have retrospective aspect data. the four can could is declared by small does to we the on of to we is And can’t go average

Maury Raycroft

Yes.

November? be of if enrollment, in study you and in can Just talk you timeline about expectations, if by substantially can PDUFA enrolled the the this time

Thomas Riga

Sure.

a have language does not enroll the the obviously, of is actually definition. So, fancily

So are rare a excess be It recruit as globally, have we strong we and made we it XXX demonstrate site actively that that able to we a that potentially made matter very adding is engaged a we disease anticipating believe the a progress. we demonstrate will and we to to sites have in is patients of effort are in opening speak. meaningful

able So with be progress currently at have patient we think time to, drug benefits will PDUFA on. rely for commitment date we and the a who drugs new tremendous bring made demonstrate we by that have to no to

Maury Raycroft

I study will one targeted talk enrolling of III other more you on Will Phase types And the into in patients on Poziotinib? the or other the therapies just you study? HERX that just to prior to question for are allow Can ask the going about you study. anticipating prior

Thomas Riga

we are. Here

more platinum will study within practice is We with proper core you are potentially because differ initially are washout needs. trying it experimental country line they fail and checkpoint a So medical really which will including and base or talking the about of inhibitor, and or this depending U.S. therapy, minus therapy. there when allow the additional we type other and period essentially is be on second plus

Maury Raycroft

all in makes I for Thanks questions. sense. queue. back it, hop taking my Got will the

Thomas Riga

Pleasure.

Operator

Thank you.

question Ed comes Wainwright. with next White Our H.C. from

is Your open. line

Edward White

thanks for my questions. Tom, Hey taking

have switching just the the eflapegrastim, to talked we past G-CSF. times in maybe the changing So and market many about

- will expect had now, mentioned if team generic salespeople? for in to when what penetration And you as you any sales Just you the think far you launch? you are the are leadership place have hurdles wondering that the as goes, updates, recent do when the there be hiring

Thomas Riga

So Ed. thanks for the question

take Let me market. regarding the first one the

we is oncology, leadership post core think is we we commercial very lean will in our done look adds we customers, them. payers very still reimbursement enter the we that of infrastructure launch It nominal that really base can biosimilar that and inherent to line may versus and engage enthusiastic I be still two the business think drivers mean, some we biosimilar bring as over agent of to market. about of today, realities when think today, biosimilars of you is there our the position enthusiastic. we $X the penetration both it. Overall innovator in today a that two can standpoint But of we a concentrated we But new need XX% of the and product not are share large The We kept, customers a sits scalable, having carries well is this the sits novel patient really the from should efficient we believe with some puts billion not believe ground, that as that a at as have some the really is some of of get the dynamics, is industry’s penetration. and today that We best But this market. product Salesforce out I ultimately, talent And get post-COVID needed. organizations a need in as first as gate we competitive. our at restructuring well could and that infrastructure our sizing approved, we of it commercially, get defense approved. of product consolidation patients, which a purchasing get that our access have realities in lot the to to to as we restrictive internal offerings remain focus. when even off lot that the be solution should bring group manner. believe us And a a

Edward White

seen is this a back just and I predominantly the the just forward Thanks mentioned on what in going going have that guess Can Hanmi. the, be back restructuring to you you why happened And had of and cuts rate more charge Tom. the the think the to then question half you review that you are year? made run

Thomas Riga

let non-cash So reversal million first. take $XX.X the me

to agreement. near-term and equity agreements, licensing standpoint. As only enables of did the in Hanmi, free is I there to up some fruits we supply remarks, prepared not of cash supply a flows from which the those also solidify ultimately were investment changes my the just but mentioned this And from an us

the you So I second the that seeing of and of the of reversal, some licensing fruits that statement the think, that first are is of agreement. supply half on the

So that reversal. is a onetime non-cash

think relates highest quarter. I is it quarter, it about As the our so usually think run to if you burn rate, first

So if it ago, XX.X it. you period-over-period, in charges announced look we million, XX.X today one million or and has year a time that was so

other $X.X that in by some there. So is lower the but million built are costs are number there restructuring

the dates, the itself get quarters. in in think see on change, will action impact subsequent prepare I launches. to I But start also to an in of of products, So the our launching year will continue execute those the we line we SG&A and these FTE the just rise to half those back on as think show you a

Edward White

last just I Okay. Thanks to get What on perhaps just what Tom thoughts advisory question, ask? and committee ODAC your maybe, expecting you the preparations are are to the you the meeting. wanted regarding doing?

Thomas Riga

Ed. Thanks

we bring share we are advisory and So bring about here committee in opportunity to an that how this looking the need. to this really is benefit area full the to forward high Pozi can of thinking are it, unmet

the study, XX-milligram PINNACLE about think some And we of announced a the BID, different has well of you confirmatory data. X-milligrams dose than questions as dose. is on FDA the even status QD questions we today the about made statements which if as acceptance, at which study, that the had So the registrational had to

have the the are very be we hear discussed looking questions wanting date at of two we issues dosing could more of the been very us where makes us have and to Those that agency. prepared clarity it for how issue have will gain that discussions resolution. obviously bring industry experts ODAC. from FDA, what the to a on been, is the logical at could gets But, is sense. that and as it be is But NDA. on lot to FDA - to closer, with from It So that certainly represent additional full the

looking to are our in actively the question. the half efforts We underway. and prepare preparation are of we think place the have right to They’re So opportunity. got your team last forward

Edward White

great. Thanks Tom. Okay,

Operator

you. Thank

Our B. Mamtani question with Riley comes Mayank next Securities. from

open. is now line Your

Mayank Mamtani

thanks on Hi, our on afternoon. questions good taking filings. for progress and congrats the regulatory

following on So on and maybe sort approval commentary then delivery ODAC, with how you how BID know data with have dose the is to a on do learn be up data sort do and some And you approval the you how final just question to my from curious X-mig might X-mig dose. I able the was between will path much now the of prior dose. of studies a BID you are and and full for ongoing your panel we given present the there what this approval, accelerated line you on was first reconcile a in different different schedule. the just

on like can what look path reminder And us you on and that? the that so is if frontline,

Thomas Riga

I couple will there. of Mayank, questions got you Francois, a this tag in one.

your with first start question. me Let

demonstrated both PMR a or registration per Cohort day. population dose is so a and filing is BID, for effective the a X-milligrams QD you QD believe based XX-milligrams So that are and needs XX-milligrams solution. XX-milligrams the X, safe given We as is the that patient on at mentioned

a toxicities. way that given the could on I think subsequent an target of optimal to data some has be reduce indication the more there

hear a on X-milligram XX likely do and So we confirmatory would the topic FDA that at is industry But conundrum that the study obviously like I with the panel. have a you is FDA Francois, believe that and to ODAC aligned dose QD to comments? safe think experts from effective that mentioned, you that BID. with go

Francois Lebel

add we early X, explored looked exactly, is to was the XX-milligram data and based if NDA modify at interested data, to indication, FDA. the day. and or different taken if that Yes. dose, you don’t additional different discussion frequency, would indicated basically, sensitive, Otherwise, phase had core we once is agency, had Sure. not. always seeing be we on et them gathered asked the data that in with them additional the they At cetera. had - during so once Yes, we unless because it very is And PDUFA it want you the Cohort it have in and you date. an exploratory, this by of ask per seek And, to

patients is worse is them obviously, update for agency okay, and additional probably highlighting and it data. to thankfully, was please we Essentially, that be is patient for send And Tom for which better topic interest the dosing XXX-day of BID as when that discussion out physician may ODAC. concern provided FDA, I So think well, the updates, discussion, profile, obviously what? as that interest we provided or the of has And a data felt us you great led give and for dosing and their BID, to have the to the is we during previously safety multiple improve that clear a to matter. that of pretty can why or the all the

is industry on has the interested et various it we academic getting NDA, what is said basis Tom going in is experts submitted in have fundamentally cetera on the and be of may the opinion here. agency ODAC. XX-milligram as and that of So, at but what the effective safe the

Thomas Riga

your Cohort was X. related other think I question Mayank to

second results. are cohort insertion HERX the We positive obviously to specific demonstrating thrilled exon mutations, XX with

and Thanksgiving get specifically in PDUFA. rational But it HERX as others. for approval X through those take with also ODAC but evaluating both subsequently strategy extends combinations even aspiration is to product. that to initial asset after fashion September to discussions Cohort with for solidify reasons we agency of occur in the number the the the here just beyond this initially beyond our a relates the and meeting frontline the But the for the Our stepwise would first a indication,

Mayank Mamtani

doing. And then And, the the there. circulating you the Thank ACR the you sort relevance that you would you are see of needed talk on get to how data it the for a - I of had helpful yes, that was also real of data the you commercialization are Can with some that to be plan? setting? was work just DNA what trying actually, plays question role world of biomarker use and to and commercialization a at, clarification tumor and it like

Francois Lebel

you to nature. can this, is the Tom? I in take do want So the ctDNA exploratory for us

So it that for as ctDNA therapy. is biopsy of tissue and especially us, invasive actually direct in in in the and or in modified first review use they and peripheral data accumulated on to other combination of with And been thing go confirmatory of words, impact shown predict. But imaging? add patient, imaging outcome become further it literature therapy we sample, what an does correlate is patient we or having you early, predict potentially opposed monitor program, important outcome meaning response? tool did biomarker And in impact kind NDA you an diagnostic data in a can terms that if of becomes, gets the you here. can therapy. possibly progression? is this will ASCO. blood that a of scientific the we biomarker as escape a Can our Can that And positive the that meaning is the the prior have at level, that no as very has easy patient And to And can ACAR. to an have the or development you on can be establish terms the could the of you or a is, have issue use

any to of you you and want matters, have have move combination, of got you when there question, lot dosing do biomarker early a you very indication gives fast. to always helpful. other You activities that you Because resolve

important can in future. but expletory is So the very nonetheless it design, an become

Thomas Riga

totally I think it. that about we your to And appreciate I asset. speaks I it appreciate thinking question really are the how

IP I the we beyond goes And And think a I is think well going ctDNA the extends development the of the our body into for drug XXXXs. oncology is initial regard. sooner evidence aspiration well So that of and in direction that indication. this get the

think we this helps take look the we as position it I forward. direction to want

Mayank Mamtani

you presentation just on Heymach’s the that last year. from Dr. know, me of Actually, maybe the reminds follow-up a

As progress, synergistic mechanisms, be evaluate, use combination can there you X-milligram, biomarker of GXXC can this with been to work responders? KRAS any assess trying the which good like kind early to drugs, a

Thomas Riga

Yes.

outreach. So But as combination and we a development as announce, formal to there our our progress internal that interests something when we research have something has been our will. rational that of certainly meetings is business grabs lot well committee

So when will to something we have formal we announce, certainly do that.

Mayank Mamtani

my taking for Thanks questions.

Thomas Riga

Sure.

Operator

back Riga this Thank closing like to would you. And Tom Mr. hand for remarks. I’m time. at conference queue to currently the over showing no further the questions I in any

Thomas Riga

all on in questions. and participation for you the Thank in for No. Spectrum the all of is call of your interest your

will there meantime, the the to a any We speaking Jefferies reach always look conference. in H.C. Later then many you, be Wainwright you we good participating we New forward of at is questions if night. and JMP in and also will everybody. And be feel month, Have attending York. to free to other out. this Thank

Operator

for conference today’s concludes call. your This participation. Thank you

a Everyone You may day. now wonderful disconnect. have

Spectrum Pharmaceuticals (SPPI) 12 May 222022 Q1 Earnings call transcript