- Earnings call transcript Q3 2022

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Operator

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

Michael Grabow

Thank Chief and issued and Nora Erin ended accessed Marketing, of release Miller. Chief This and XXXX Officer, a Sales the third Vice Spectrum Tom for months press on you, can through President its today, three Vice Spectrum press President, of Chief Dr. Relations Executive call September Spectrum results financial call. be Brennan; Vice President Investor Francois this call Executive and Executive webcast today’s President With detailing at Earlier Officer, me website Officer, XXXX. and operator. the quarter Spectrum’s release are the and Riga; to Medical XX, sppirx.com. Senior Welcome Financial earnings Pharmaceuticals Lebel;

available by and implied uncertainties, our to risks started, statements such uncertainties may notice and results one of of get sppirx.com. forward-looking after year projections website available and risks would not webcast included I this for statements be will differ guarantees A of unknown shortly and will the undue materially should placed any forward-looking afternoon. These completion The or archived on in today’s future cause known statements. financial replay actual make which not future performance results from we to emphasizes necessarily press this or be in be will them. periods future at expressed forward-looking call. telephone statements on reliance Before performance the This are inherent statements forward-looking release. Such like and involve notice we performance regarding major in the reference

and filings. XXXX. Tom archived recent discussed, the the listening to then, will I those SEC to topics Since And the related releases turn on Riga. of webcast, President Spectrum so XX, to November who press or to call company’s please benefit the call most have with may announcements is that, CEO, over For made held this and replay Spectrum’s the maybe refer

Thomas Riga

everybody Thank Good joining for us afternoon you, you Mike. and on call. today’s thank

the strategic the third two events, be am a topics covered were call. on agreement was than highlighted company approved six and I that debt we of customers. less all busy The ROLVEDON that thrilled sheet. regulatory financing the will with September very Each of our signing today’s improve quarter able significant FDA product the the to in balance these on make available for to weeks by commercially X

commercially that Spectrum our turn one commercial Hanmi on are we This opportunity. pleased Spectrum factors As significant our The competitive the and long-acting $X October within focus to maximize loss a allow trajectory and XX, There qualified in Spectrum’s a opportunity the of accomplishment growth team capitalize our organization. feel uniquely factor both days favor is being to we the us billion am The and is history where estimated available working market that will is I commercial complex. But this first Pharmaceuticals. is largest leadership has and several extensive our are We partner availability. ROLVEDON of sale in for entering happened marks of now significant market ROLVEDON. experience. to

First, studies. X and has large safe it to Phase proven two in effective be

the in-depth resources learnings research. we extensive support customer oncology from experience. to team customers Additionally, and possible a strong a And and finally, launching with of market best connectivity market we’ve with patients are provide with knowledge, hired full suite

and the will and over neutropenia commercial a can behavior. and effective ROLVEDON across open both units buyers administered the likely is compete the tremendous and that has with non-inferiority febrile long-acting in into be while the enter market qualitative The X the over clinical Let predict of the lost enable United biosimilars complications. severe on growth product unique market share. will product strategy biosimilar in understand years. biosimilars Right quantitative robust fastest early share some neutropenia the effect hospitals ROLVEDON now, with are a past oncology program. on XX%. million with demonstrated four concentration us indicator foundation a of neutropenia States research incidence In incidence an trajectory. significant the safe ROLVEDON change are of patients three as We’ve and a details. full to got long-acting effective available Neulasta duration every of year and not quarters. XXXb the the product XXX is structure represents Phase duration to large and few the be success. estimated There leader to of is driving that split their and has is two oncologists, and factor head-to-head the space represent Having is In studies, Providers payers Neulasta. to and segment drives The of of of launch believe fairly demonstrated mix BLA severe versus hospitals. to me is XX over segments, what oncology on-body disproportionate evenly is XX% device share market non-XXXb the and and segments. you goings, novel first a the two G-CSF downstream a with market a $X.X path amount proven associated our in a currently phased the to the and molecular in evolving we are leading community An

climate as dependable and which make networks. segment and decision-making. result acquisition dynamics. to are segment another’s operations. led multiple and dependent on several are community the headwinds, fact manage innovator hospitals. multiple decisions was contracting growth product reimbursement by a With by This has an a across been oncology practices has factor and price across to facing decisions products Over made more Historically, for competing consolidation selling unpredictable the space has the practice their is average the to is one the market driven stakeholders. tailored This centralized able in biosimilars of to which nimble years, relates consolidation I to their receptive the the long-acting past in as unpredictability discounting This that business created stable

innovator a Now novel more reimbursement in a predictability ever, their on business near-term long-term. for offers decisions solutions decisions. will that that that long-term tied ROLVEDON factor means managing visibility near growth has this or Ultimately have that will customers the is greater than in and customers contracting into and business are to not and independent pricing, flexibility discounting the provide looking their biosimilars. been them not more biosimilar product product we offer the

access and programs Finally, has offering the bringing and to utilization of high oncology a are community market. the support comprehensive patient we segment

customer on to We financial has reimbursement help have best-in-class have optimal understand taken patients built their ultimately and caring the – customers a burden cancer and system ROLVEDON. will experience to that dedicated assistance, include the the ensure co-pay that our patients support patient employees and support with

community will and We oncology establish the first non-XXXb ROLVEDON hospitals. practices, followed XXXb by with

oncology and significant strategy marketing, medical commercial strong The and with and us Keeping this build in will access in comprehensive ecosystem. evolving and a was a enable successfully customer extensive have strategy team sales, to relationships. operations commercial affairs. experience to oncology reimbursement, compete commercial includes We which efficient the team personnel

XX competitive of is increasingly The targeted instead trained, hired executing this have a where and team nearly physicians. We already a launch time team is our actively customers an restricted in and face-to-face strategy. more all environment fully Having selling is advantage at premium. is access

plan the We gives developed that hire us on we confident of are the that and ROLVEDON. best to that the opportunity we the people launch capitalize have

had for have active we product now is an outcome Turning November that and with ODAC XX. date vote We cancer for and in of lung other expected NDA, received the meaningful patients X whom treatments a present rare X. to PDUFA of the its FDA failed. to not believe at a could form was this Poziotinib meeting under negative to of option we September which review continue This treatment a with had obviously

FDA the costs what be of unfavorable planning will which include various do approach determination, implementing decide, predict in we pragmatic to cannot we organizational adjustments. intend we ultimately we In and outcomes. will in event managing further While which our not an the In approval. particular, one for are receive

company, We will continue shareholders and best depend the importantly, to most our on the act who patients of interest in the medicines. our

to from that, review are to let cash strategy. call in on over million have our on to turn the me Nora, Poziotinib In are We hear the will the timely launch as time, heavily on successful from of we the word program provide ROLVEDON financials. just once $XXX very updates focused the Nora With we our you’ll well-capitalized we receive execute mean over FDA. and and

Nora Brennan

Thank you, Tom.

in compared from quarter in period $XX.X million million to compared net in year. stock-based drawn $XX share administrative the of related in overall $XX.X $X.X was to cash net Operating to of loss period and of share, of third period company the due well to and which $XX closed The reduction in in The programs compared the quarter. associated This is development to XXXX, the million the late-stage January in the benefit SLR of or as quarter the X.X approximately to with headcount of loss a optimizing cash employee the in decrease lower compared operations to as primarily quarter part expenses compensation. to $X.XX as burn The the we ongoing ended as third for reduction of the XXXX. million $XX benefits during is million $XX.X XXXX. strategic strategic $X other in in in was addition ROLVEDON, Partners cash same of burn million personnel to debt QX, million Selling, same $XX.X that in expenses research in million million approximately expenses general, $X million January or per decrease announced related period assets. expenses completed marketable $X.XX same securities, were efforts the investments For cost in decreases was continuing our the Capital million reduce includes comparable decrease $XXX.X last We with down in were of total began million financing with of part associated restructuring our the a and XXXX. per to in relating with $XX million XXXX. in $XX.X due primarily plus quarter, compensation the while agreement million, workforce

open down achievement As such $XX regulatory financing to available discussion are made three and in million subject available our pre-specified The draw for tranches of financial – milestones. of of at please the points additional in be operations will questions. reserves operator, that through the we have the cash on And for believe XX/XX XXXX. we line company hand, and fund With this with XXXX. the financing to that,

Operator

comes Murray [Operator sorry, – Our am first Instructions] from question I from from Jefferies.

line open. Your is

Unidentified Analyst

and this starting Murray. questions. my taking is on Kevin Hi, the for thanks on update for Congrats

are call well. was and forward? just to during would any you And are question able to what on then, what next the information on the street earnings be you going the to early you on provide when be launch? First going provide if thoughts have you as to metrics going And tracking guidance,

Thomas Riga

are start you? How Kevin. Hey here. I’ll

thrilled We the with available having be launch are approval and seeing of receptivity. the the obviously the product

plan metrics are be going have your lot internally. tracking on today. we here don’t we providing guidance of a question, So revenue we’ll To that to

as we the onward think will the that metrics think be to course we’ll as relevant most relevant be the the and revenue think relevant that be But important fourth of to access relates term. will quarter most here of one and launch. the one also and be ultimately will line providing as street I the I over revenue will here near as that’s reporting is that I well customers it reach in happen here

Unidentified Analyst

it’s differentiation sort follow-up ROLVEDON just Thank that you, of at of points so you to of premium is spot sweet slight for elaborate pricing most think a that priced been there research on price just than – far? Can the And the with aside payer And biosimilars a Neulasta. feedback market Tom. that Great. then, that less question any up if the other you makes and commercialization? pointing are differentiating you resonating key but the the have then, for customers,

Thomas Riga

Yes.

is I lot resonate foundationally, think A that feedback think really having of think think the safety has that’s of think research over products – efficacy early X to program XXX is, Phase the it robust and the I I I patients I pricing. into went of and foundational.

innovative to and think that decision products. XX% be as the an are a It I we lower than launching brand. is other innovative this we made BLA

take you the are price to the that price XX% with be - average all our I think acquisition have differentiate well as the at is to spot our I our as access. a product that innovative think referring important sweet two thought as and gain the somewhat payers, price research selling of wholesale us we we VAT and ability receptive it’s customers, from the our enabled the to of with customers product other to reduction to

Unidentified Analyst

Great. back the in queue. Thank you and hop I’ll

Thomas Riga

Kevin. Thanks,

Operator

a we White with And you. moment, Thank have one from Ed H.C. question, Wainwright.

line open. is Your

Ed White

Good evening. questions. Thanks taking for my

Thomas Riga

Hey, Ed.

Ed White

Hi, Tom.

any just the it’s Have go any couple far from as the pretty a on the launch. – give does So, can payers? gone as payers feedback there it of smooth? us questions like you look sticking Have or been you points

Thomas Riga

Ed, the thanks for question.

a important strategically. who us, ultimately think who physician payers. a think with And customer question, and an time believe But engaged spend one lot it that advance think there. lot ultimately have And seems customer easy I for the a we that is payers, as very it’s work and resides starts treating of I but in I is the patients. it relates is like to we of

understood We of semi-annual. of relevant are over have contracts, represent some that have the lives are their are XX in marketplace some and this time covered targeted annual, cycle that particular their expectations. half The payers we

each be So one evaluated will strategically.

who of we with are strategy good customer strategically as we expecting. contract payers clear books customers we of their to our the particular then and think have and I So and is is business. what it approach those to a be plan on How here they engage idea our

Ed White

big How any Thanks, just we was Would on over more there thinking to give that? Thank ROLVEDON going maybe a much you two I the expected Okay. same something of for guidance quarter? see question we on for you these you. be be here. to us can quarter? R&D, us is I Tom. forward, few And should fourth just, the mean, fourth is can pretty spend quarters? a the in Pozi? expect give And cost SG&A R&D if with question guidance looking after launch next see Nora, the then, there wondering Or bump on we should and the forward any

Thomas Riga

start, let Yes, and can will be then, hopefully me here. it helpful Nora jump in

company. since been to the January a foremost, balance to tenant burn that think the sheet I the cash So, core we’ve and first reduce had operating really has scrutinize and of

neighborhood go. the So we where it and to that are assets, I if quarter that and the burn for think the XXXX which a burn you test late-stage as think in ensure decisions of in even investments the that of our seeing ROLVEDON rate funded company we look speaks implementing you to are in the rates ROLONTIS think is of $XX.X discipline because to to was I thoughtful relates we fully then we burning making full launch are at and million quarter $XX and the starting going in million are I this XXXX, of somewhere

about be uptick quarter, costs. As S&A will an fourth you the there in think

that until have base point if the commercial because what think start XX I that important not Poziotinib We think an the organization that And had, accurately. one. guidance given But I think specific question that’s decision on is the we’ve we I’ll of you incremental question component somewhere that R&D, one think in ultimate neighborhood FDA’s the to added into visibility we on the we ramping is to think on answer XX. have I the that of FPEs XX when to I about

be in we back So you. will it order and make we touch decision in and we with that and prepared timely we are have, will for

distant hear I You to the we in too give not ultimate will on more you depending future, thinking color the as which think will how are outcome.

Ed White

also, that ready sales And Tom, end the as goes? a as on for you there. positive ready are and you Does include is manufacturing that if products? far Pozi you there outcome Are both said force of

Thomas Riga

is fully we ODAC truth ODAC history here seem we expected vote, ODAC, different of XX% and think a think nuggets judging we I I of these So, that follow having outcome X understand the we time there note. at – out I the not of But the BAS. there is to – obviously, jury X, think Yes, and a has

quickly. the preparing outcomes be So make in all quite prepared pragmatic or are we decisions are those think CRL to scenarios, I up of obviously be potential for an to to including approval and both and of we going

Ed White

Thanks, question should Tom. at Is we should be last Are thinking there the may? looking Pozi outcome? internally But BD thinking And pipeline, your the with about pipeline going picture the of if we what’s my you anything Thanks. pipeline? Just regardless I strategy then forward the big overall be of? opportunities? on how

Thomas Riga

Thank you, question. Ed, Yes. great

the picture for approval company, to as opportunity but we fold. have big launch success approval not thrilled the think are comes bring for I obviously the and ROLVEDON into of that would for what just

believe Poziotinib, company. will of execution in ultimately certainly is of to forward. is is So, the development the contingent to business type other what energy further the expansion with that sheet, go the and really those both balance and into things important having our efforts have successful capital to and the future we crystal ensure of why distant of in funding the here interest strategy the which clarity is really critically clear the company, clearly, but the too long-term a the business development of being our great, to not future, company of have activity is program but are of we near of commercial core launch the focus to core future that’s having invest term product us. largely our front because of the what important And successful we M&A we upon enable advance in our our ROLVEDON or All of organization, as

Ed White

questions. taking Thanks, Great. Tom for my

Thomas Riga

Ed. Thanks,

Operator

from question with Thank next Agarwal our you. Prakhar comes And Cantor.

Your line is open.

Prakhar Agarwal

thanks Hi, questions. taking my for

one discount So Alaska. pricing. brand Tom, on the of XX% you the mentioned to in first pricing the

I to steady how follow-up. of be So ASP given way expect both talk had are expect at you about with brand the level biosimilars than a And will the state strategic earn in assume and maybe higher your discounting the and to Alaska ASP do would you that very the you payers? much What out? being –

Thomas Riga

the for Thanks Yes. question, Prahkar.

that think I has of for the for administered remained of past demand result factor ASPs drives units and in their has is the been fact that’s growth it’s X.X that What consistent. question your years. is in unchanged million tied the the important the decisions. down to biosimilar and that demand market the the unit innovator and is ultimately several discounting growth There inevitably the being largely together reductions factor

quantity I think independent decisions as make to having us our enables a unique price product a to unique of ability kind those strategically. discount

So, is selling that of ASP’s established is few discounts into direct, initially, price put established, launch. average make control quarters of basis that CMS. reportable direct with the is happen reimbursement And selling that, ultimately decisions in the the our that a that is that those average then, first wholesale price the when acquisition in we until is will discounting the we after price over

ours selling manage. in we discount decline the price will market subsequent of and into then the unilateral be to be in the average So, will put control

Prakhar Agarwal

program. color. maybe co-pay it. Got for about And assistance talked on you patient the Thanks the

provide and products the details if around if And more other in programs you between So, your market? of differences there the are can any some that? maybe

Thomas Riga

Yes.

have the treating important of like this and expectations customer it’s think have are like you think – I patient a I them. to entire journey we that thoughtful are brand,

customers the mentioned full reimbursement is help So, dedicated But of our well program executed. going funded remarks as program, and funded to programs, populations, prepared as there and how the will navigate. in we access in be both my in programs a themselves, had suite that staff co-pay will non-federally differences that’s assistance both have are federally both as programs, I

offering it So is I bringing that out as a here gate. receiving other I have, contrast the would market are customers here position our you this are the when to products we of and way with the treating brand compare think it and think compelling a well I

Prakhar Agarwal

for you color, looking Thank the and Tom Okay. next the update. to forward

Thomas Riga

lot. a Thanks

Operator

for the Thank you. are to other call I’d turn back remarks. Tom And in closing any like questions no the queue. there Mr. Riga to

Thomas Riga

excited call move a Spectrum interest here to for in and the been further time you ROLVEDON we busy on launch and as of the a you forward. on the today Pharmaceuticals. in participation and company Thank your active are your updates give It’s we

So questions, free in touch. reach you and any have to feel out if please we’ll be well,

Operator

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

may You now disconnect.

Michael Grabow	Executive Vice President of Chief Business Officer
Thomas Riga	President and Chief Executive Officer
Francois J. Lebel	Executive Vice President and Chief Medical Officer
Nora Brennan	Executive Vice President and Chief Financial Officer
Erin Miller	Senior Vice President Sales and Marketing
Ed White	H.C. Wainwright
Prakhar Agarwal	Cantor Fitzgerald

Spectrum Pharmaceuticals (SPPI) 11 Nov 222022 Q3 Earnings call transcript