Earnings call transcript Q4 2022

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Operator

Good day. My name is Andrea, and I will be your conference operator today. At this time, I would like to welcome everyone to the Karyopharm Therapeutics Fourth Quarter and Full Year 2022 Financial Results Conference Call. [Operator Instructions]. Please be advised that this call is being recorded at the company's request. to President call of like Webb, to now Vice Senior Investor would turn over the Elhan I Relations. Please go ahead.

Elhan Webb

Thank for joining a press to thank and recent you today's financial We Year and Fourth call issued progress. Full Karyopharm's discuss you, conference the results and XXXX release company us Andrea, on Quarter all reference today morning our financial slide and available This XXXX. year with website. detailing results a quarter call this release, that presentation during on our will we full are for the our along fourth

on then remarks overview on call, from as start X, today's opening an up programs. Richard, we provide a For clinical our by for with of and update year Sohanya, call and and will closing seen development remarks, quarter the will Slide the for Richard Richard provide Mike update some I'm before provide will highlights will commercial XXXX. with Mike. XXXX guidance joined full Sohanya and some questions. Reshma open call Reshma the end financial will present an

of SEC Risk formal future. Securities I'll of Factors other on as make our begin only. forward-looking result a the in the forward-looking our may results of file including in SEC for of those outlined by those views as represent section harbor Slide from the of our indicated Any remarks the we filings and various the constitute important forward-looking comments, recent make these Act the statements may we as remind statements statements in purposes various which with you safe today under XX-Q X. discussed Actual with most provision that form, is factors, we Litigation Before Reform will Private that today on XXXX, differ materially

forward-looking them not do elect statements the may some these update you rely views even we any should to if later so to our date. of views obligation future, change. as specifically Therefore, on we point any disclaim as in representing our at While

an In addition, XXXX. our we will R&D non-GAAP, also call SG&A for be and on outlook for this providing expenses

are available We of because not efforts. reconciliations which stock such without are these measures non-GAAP forward-looking is not unreasonable projections required reconciliations compensation providing for expense, of

over X. turn call Please turn to will I to now Richard. the Slide

Richard Paulson

Good thank morning. Elhan, Paulson, you, everyone, My name today XXXX Officer and Call. and joining Karyopharm's Thank Full for QX President us you, Executive Karyopharm. and Earnings Richard of is Chief for Year

selective an on Slide in which to target and As export, cancer. was X, where today, inhibitors and Fast continues mechanism as earlier action outcomes and to And patient in we patient-focused move leveraging XXXX. now see upon you first-in-class XPOX improve developing can XX innovation myeloma to of which founded nuclear oral countries our in Karyopharm company Karyopharm anchored myeloma. forwarding around lines are existing our this successfully fundamental of therapy multi approved commercial build is drug XPOVIO, into multi franchise to in

from XXXX, year. $XXX With XPOVIO partners, guidance royalty revenues our in and generated U.S. revenue, have we our for range payments our million meeting U.S. ex milestone total the

of phase into next where on. later detail and further sales, more our and revenue our grow growth, total Sohanya for positioned go XPOVIO will well expect are which we Mike we XXXX, For to U.S.

programs doses have will unmet need that We with high efficacy clinical with we have suffer we mid- believe pipeline the late-stage patients of highest probability lower where focused of and a improved and who cancers tolerability comprised development help from demonstrate success. can at

have regulatory of extended third cancer existing conducting our with Through multi myeloma focused Phase which III the both included the stockholders and feedback. from sheet investors, Myelofibrosis, runway balance cash III late recent expect we our in and start disciplined Endometrial continuing XXXX We a participation our are in we studies and through in strengthened which by pipeline advancing study financing, approach and XXXX. half Phase pivotal a new in both to pending pivotal first

we believe we our leveraging commercialization have capabilities years multiple approvals and phase we our value of proven next mid- to achieve X and to late-stage potential and we Collectively, shareholders. growth, next product development as the deliver generate X over to for established patients work the to as

now Turning Slide to X.

by review competition, as programs. 'XX all despite XX% X made we to 'XX. core compared net key some XXXX myeloma, grew Let's progress have accomplishments XPOVIO in from increased multi across programs our In we U.S. considerable sales in

to cancer, will our III leveraging go that performance benefit novel moving on in myeloma observed TPXX potential we've moment. are Phase the forward in into excited patients be with U.S. sales a wild-type. that by substantial Sohanya of we Endometrial more multiple biomarker-driven are a In Selinexor details in study

Our partnership will a Medicine enable with us companion diagnostic. develop Foundation to

In including are domains, relevant TSSXX results very the preliminary Myelofibrosis, I by study SVRXX, from our hemoglobin we Phase encouraged across X stabilization. observed and

need, unmet the Finally, recruitment data study. looking to in refractory for the a II high-risk are with and analysis in we a seeing overall population survival relapsed interim mature very forward Phase completed high our MDS,

I turn now the her As the performance the for year commercial Slide over XXXX. to to of to X, would review and quarter we like for call turn full Sohanya

Sohanya?

Sohanya Cheng

multiple talk evolving and within be the typically unmet The there and patients clear the XPOVIO On Thank landscape. you, treated morning, remains with despite I an an of of options. with X first incurable. is Richard, to am classes role proportion lines anti-CDXX we advancements therapy, major Slide good an X, myeloma second about treatment If we antibody. look need to being It everyone. continues increasing pleased in see the of utilization disease at of

need to action. a a is class Following this, of switch mechanism for novel there a

forward the to of there therapies. standard the care. rapid we second move fourth no advancements setting, now to clear If setting, see line emergence this re-directing we T-cell late-line is In of with

fourth treated a prescribers, strong the However, continues proposition setting combinable complex patient for typically community patients medicines to line academic to infrastructure effective, can are the terms of and as have second oral easily these the largely value therefore, localized an and be Thus, XPOVIO manageable administration needed convenient management in therapy. who to setting. in by

efficacy rationale XPOVIO an to and In regimen. support addition, following we of have data the use strongly anti-CDXX

of bolster the Furthermore, XPOVIO around physicians, re-directing with the exploring a T-cell the in for setting. to in topic and particularly becoming therapies building T-cell positioning is post effectiveness more see we a the of is year leading T-cell to of the fitness this pre- data academic role multiple of and treatment the area therapies, course in myeloma mediated of further expect in this playing concept the Karyopharm increasingly generated emergence evidence body landscape. our and through critical

Slide a for full on and year in was XPOVIO we both year-over-year grew primarily new our XXXX, In therapy. their continue highlights refills fourth treat This the patients more extend as growth, to by X and included starts Turning net commercial revenues versus driven our and quarter XX% demand XXXX. now time meeting with to and guidance. increase XXXX, we by which XPOVIO

the team Our sales about primary in prior executed with strength, area remains sales 'XX The XX% of community XX% of setting in community QX. a in delivering year. focus, growth versus contributing to

ongoing competitive XXXX by therapy December, was of novel In sites in grew clinical in the and trials, commercially versus class sales becoming entrants, academic one in including expansion we X% available XXXX. which of CAR-T new impacted setting,

lines to therapy. into increasing and addition, we duration our growth continue In our across drivers, progress make of including earlier shifting

perception advocacy support the XPOVIO continue podium the medical to clear at at for of seen from also improve product and congresses. We with the KOLs

As walk XX, made the we of let's have drivers. details Slide progress growth turn across to key through we the our

rapid roughly duration with of the to earlier shift in grown proportion now to in lines growth line. have patients into XX% in driven third earlier continue in by With second lines, the line, we year-over-year. increase the an We XPOVIO patients of see this fourth

our prescribing Finally, increase accounts accounts the as use the the community. of in breadth to across with of expand roughly we being XX% continue we U.S. of number

these XXXX, to guiding million as we range drivers. We're in XXXX at XX, Slide net potential U.S. to growth approvals. with expanding product which solid On million, we believe $XXX on competitive of year-over-year revenue We further focused competitor a landscape X XX% range that $XXX new to remain to this growth. the reflects guidance expected represents intensify further midpoint look is growth a

adoption ongoing GTN increased by in sales hole and higher driven reset quarter QX setting the anticipate bail a from the and We donut academic with Medicare given in prior the line tech of IRA pressure rebate.

leveraging We further and base will team, continue prescribers field the a in our experiences to building community, and well-established broad entrenched use. execute with positive of their expanding upon their

anti-CDXX. We positioning to continue second fourth in also post and line the plan to XPOVIO messaging

in we In rapid most saw growth the third XXXX, the line.

line focus our accelerate on remains growth therapy. of continuing Our in to this

pre In generate plan addition, and in XXXX, to institutions with engage key academic to data we

line. in Post-T second therapies, potentially our fourth cell mediated position the Further strengthening to

Phase look III pomalidomide with of on community approved. to look term, challenging and targeting incurable we to a that in setting, expect the oral focus will we combination as and in long key the We Finally, all and Selinexor mid benefiting build disease. dexamethasone a the forward if this with be future to study driver continuing grow patients of myeloma and more franchise, our XPOVIO growth,

Now to the give I would like Reshma clinical update our on to over pipeline turn to call an progress.

Reshma Rangwala

Thank you, Sohanya.

diffuse XX, which are see high is have XPOX is in novel Endometrial brand FDA being our Myelodysplastic Eltanexor need, X can name cancer pipeline Selinexor myeloma our of the unmet multiple , in hematologic It in on inhibitor and complementary multiple neoplasms, XPOVIO Slide differentiated and large being B-cell solid including malignancies. across tumors lymphoma. you signed clinical we and multiple both myeloma. Selinexor currently overview Myelofibrosis, is compounds: As of and investigated novel cancers evaluated and approved first

in with is lower Selinexor, Eltanexor currently barrier and being blood second brain relapsed/refractory inhibitor to observed is investigated penetration is our MDS. XPOX Compared Eltanexor. a

ICXX, continuous it's Selinexor, is of addition, dosing. than which enables a In lower more potency measure

models animal to to inhibition fact, In activity. enhanced select been continuous shown lead antitumor in MDS, XPOX evaluating has

XX. Turning now Slide to

first the improve lower our We overall XPOVIO's to are coupled its allows in patients Since by experience, their optimize of with from which the clinical improving benefit XXXX, observations across clinical and ultimately stay trials have doses working optimize that real-world of tolerability, demonstrate longer patient therapy to approval utilized programs. own dose our can benefit. on Selinexor Selinexor we therefore,

of result, clinical weekly. of XX milligrams ongoing a XX once a than milligrams doses milligrams of approved is twice half trials our As Selinexor to doses original the weekly, quarter or XX incorporate all less at which

the why On unmet like cancer in discuss Let's would now find need women. Endometrial turn Slide exciting so and for I cancer. we this attention to opportunity our XX, Endometrial to

recurrent cancer the United cancer with wild-type. XX% is of most the form Endometrial in or TPXX First, approximately of common gynecologic as advanced tumors classified States

disease line Second, given survival NCCN is watch-and-wait the consists approach approach the guidelines rate a first Upon population chemotherapy. of recommends improvement advanced This X-year recurrent current until only treatment that completion or patient of in landscape clearly Endometrial XX%. for progression. chemotherapy, cancer the needs this

established subgroup well classification ASCO evaluating data patients a compared wild-type believe to other is we treated As therapy cancer previously for these the whose tumors maintenance X.X potential as in clinical cancer study median option types, has maintenance in disclosed the months to a months we of overall from analysis XXXX, orally Selinexor improve wild-type presented subgroup with Selinexor in At analysis A Selinexor the showed and patients. offer molecular progression-free is with were administered patients demonstrated and and maintenance Selinexor XX.X that treated benefit TPXX placebo. TPXX the therapy. Endometrial and SIENDO a survival for patients

Endometrial increased our compared the achieved who TPXX rationale from update placebo in now that wild-type the Selinexor in as has wild-type the of median evaluating benefit therapy the are study no profile. XXXX. shows change in Selinexor that improvement ongoing subgroup EC-XXX patients data safety in be the pivotal this This Slide survival evaluation for with in months cut months updated subtype are November are -- to potential in for a PFS tumors progression-free This TPXX observed this underscores in on wild-type XX. the the with molecular of XX maintenance highlights whose seen X.X TPXX PFS Selinexor to signed supports Slide and On as XX.X as compounds results a for can cancer

Top study The survival. collaboration are XX Network , patients with to randomized GOG, test of Karyopharm identify Trial are Oncological overall XXX placebo. either expected and will ENGOT half shift Gynecology XXXX utilize of TPXX a study whose study's line the European once wild-type second key the of Selinexor tissue-based weekly a the Gynecological cancer. endpoint of Group Group. manner for Oncology results to is total Endometrial receive primary be tumors dose is a Foundation a will The survival for secondary and progression-free patients represent one-to-one Medicine's sequencing women wild-type. could TPXX or milligrams and with between This in paradigm in endpoint at A next-generation a

Myelofibrosis. take now a at look closer Let's

of who or benefit. new JAK-naive Approximately a is that unmet see The can current care, TSSXX novel patients Ruxolitinib patients lower milligrams the as standard X/X about is XX of an X for with a patients to and These week key at need XX, is that patients real-world these or patient at day. evidence twice important the data therapies are a well and given patients you day. for of key Myelofibrosis. XX XX. limited treated treated Myelofibrosis on efficacy start As populations limited on are survival of there suggests are Ruxolitinib approximately with given do critically twice half for majority and XX% day with male substantially high twice SVRXX a and both achieved of not with mechanisms milligrams Slide less the The of patients patients action males milligrams XX%. of is that rates only SVRXX as comprise are Overall patient populations Jakafi approximately both the

potential survival, a disease factors size, spleen decreasing has patient of levels, all in profile. of the all overall patients, improving to including stabilization modification, enhance important hemoglobin the increasing Selinexor to symptoms, context manageable safety multiple

As other be AKT, pathways inhibits downstream it to as potentially JAK with activity may XX, on potential very targets. monotherapy as as combination Slide XPOX potent inhibitors and well effective multiple of can including STAT in This JAK, ERK. synergism and lead seen targeting

XX. Slide now to Turning

the Ruxolitinib and to frontline Myelofibrosis portion and I see study, a Myelofibrosis. patients. our naive we design enrollment study, XX combination of In patients study the with of of in evaluating I can Selinexor treatment dose the completed Phase Phase You this

both and objectives activity Our the study of of building compounds. on are for explore this to combination Ruxolitinib, the Selinexor single-agent

reduction updated XX% on Turning or spleen XX. results data greater October We patients shared at recently an Based at to XX. evaluable XXXX. volume Slide XX% ASH of week cut, a achieved

and with X-X or addition, included had evaluation of being stable evaluable at of transfusion which X anemia most score XX% week with common XX% those symptom or treatment-emergent reduction had well their XX. forms last observed a patients finally, XX% weeks of greater independent thrombocytopenia. their In and of least combination The And hemoglobin reported at a completed follow-up. of and manageable patients, Selinexor hemoglobin safety profile patients rates Ruxolitinib XX% X- events levels their Anemia Ruxolitinib who generally a treatment, symptom X was who were Grade the improved total observed their at the alone. tolerated achieved XX% Grade the The adverse combination less than with maintained

patients majority Phase medical scores from assessment including study with will XXXX, I enrolled We patients' of plan observed this improvement results in will from the Ruxolitinib present from Selinexor collected a updated of study. in analysis TSSXX the the and to half symptom of incorporate symptom first robust the a combination charts. that enable This of this

of patients achieved of XX% achieved spleen SVR of week see at XXX% and any evaluable or greater Slide an reduction. you XX% patients XX degree can As XX, evaluable on volume

on our analyses data from the study. I Slide the subgroup Phase XX, portion The XXX of new

Specifically, we cycle or Ruxolitinib reduced the on their for and treatment. whose X-milligram duration cytopenias identified patients to due dose X who this was X of at remained to X

XX% with "long-term with monotherapy in patients assessed subtherapeutic twice who in Ruxolitinib, prescribing in monotherapy quote greater at combination. patients noted in suggest reductions their of a their underscores Despite that a reduction has Selinexor maintenance at XPXX both experienced subgroup, as shown Ruxolitinib daily experienced spleen leveraged responses" and of combination data potential equal in be treatment-naive or potentially information. to not as that interested are in to These in all symptoms dosed could in reduction Ruxolitinib this doses We improvements mechanism given X X with this as spleen all milligrams may Selinexor the patients activity volume. have and that Myelofibrosis week XX were the fundamental and in

of the this benefit the population. population XXXX. XX. therapies optimizing Myelofibrosis, coupled broadest XXX having Slide plan the observed anticipate defined to on observations maximize effective we to from of by half the plan to need Turning study, in develop JAK-naive in this Based first our the the development with are We

Now and turning Eltanexor to MDS.

States median in approved Prognosis Slide patients. poor diagnosed are see As XX, expected currently with MDS HMA-refractory United for survival is disease newly to MDS. diagnosed overall with in approximately of you standard can HMA on of XX,XXX to are and X care higher-risk the current XXXX. are have no people HMAs been to for high-risk a intermediate X and MDS the therapies months, refractory there

XX, design promising Eltanexor overall our approximately of HMA-refractory Phase relapsed/refractory activity the high-risk Phase the Eltanexor patients agent MDS, among demonstrated of you I XX portion specifically the see II Slide can single in In median of On was with months study study, MDS. observed. a survival

completed interim in and to have XXXX. of enrollment half the expect report analysis and II a study results We first in our safety efficacy Phase planned of

I hand With will now that, over to it Mike.

Michael Mason

everyone hope you, morning having Reshma. is and thank a I lovely

financials. begin Turning issued press we financial the earlier Since Slide to a results, just XX. focus today our will the I release with which on highlights, on full

the million year for of XXXX revenue $XXX.X compared XXXX. year, full with revenue was million fourth for quarter of for the the million total XXXX. million the to $XXX.X of fourth for XXXX our was $XX.X In full to compared quarter line guidance Total $XXX.X for year the

license upfront XXXX, from $XX reminder, we recognized including and $XX.X As the payment of quarter of Menarini. million of in million a the revenue, fourth other

million XXXX of $XX.X to quarter XPOVIO compared million year commercial sales and was from $XX.X $XXX.X the revenue commercial the representing of gross from was was full for discount the million, XX% million for was quarter full the the fourth net of XXXX, product product Net XXXX to revenue Net XPOVIO guidance for sales the a quarter XX%. for for increase XX% fourth compared XXXX. our year-over-year. U.S. The in $XX.X U.S. fourth for meeting XPOVIO year XXXX for of to full the XXXX year, of year

expect for to We range net discount the XXXX. XX% XX% be gross year to the full to in the

of for of million full $XX.X our clinical first our pipeline, fourth expenses compared cost year continued studies, $XXX.X of for with $XXX.X XXXX. to these half consistent, and from an pipeline. the fourth progress million pivotal the for XXXX million the headcount were reduction R&D X year XXXX for cost advancing be compared initiate quarter to expenses in the quarter remain decreased focus expect R&D measures plan XXXX from and pivotal R&D ongoing and including full the core clinical XXXX, we the million in of offset XXXX, due costs mostly in The decrease which to are our which related to we make XXXX. during The attributable primarily pipeline of programs to in XXXX. clinical was additional the on expenses prioritization programs our X trial to one will the costs to clinical continue increased as and our $XX we included saving by relatively In initiated prioritized overall

$XXX SG&A On cost to Delivery. a quarter $XXX.X were -- XXXX year with million full following excludes December XX, XXXX as for slightly increase, the the of to cash we quarter $XXX.X restricted basis, as increase non-GAAP million totaled December SG&A completion the year. XXXX. Cash, our expect placement private SG&A investments year were to fourth compared in with of in total consistent XXXX. and expenses were expenses SG&A XXXX fourth line cash million R&D million, of equivalents, the inflation successful of our for of for December with stock-based $XXX.X expenses compared million guidance increased expenses XXXX, XXXX. compensation, and to XX, XXXX, in our which In line and the for million, $XXX in $XXX.X million, $XX.X full

to plans, this we milestones. recognized earned reminder, related a receive operating revenue total and primarily Antengene million product cash revenue be expecting we U.S. milestone million $XXX $XXX license payments Menarini XPOVIO from and net in quarter. consisting to $XX our to to partners Antengene. XXXX previously royalty of and our Based expect As million and of earned current on are revenue from for expected

million million revenue the of product and We to million $XXX be XPOVIO expect U.S. stock-based million; year expenses, $XXX expense, of XXXX. in non-GAAP, for SG&A excludes of range $XXX to to which full the compensation net R&D $XXX

existing investments planned will revenue our our equivalents the that well and sufficient into XPOVIO finally, cash as fund we revenues generate late to from And and as sales expect XXXX. product license operations cash, to other be

I'll final and thoughts. now some flip for to over Slide turn And Richard? call the XX. to Richard

Richard Paulson

Thank you, Mike.

as We number Slide momentum a of are focused catalysts as XX. milestones of with see maintaining you near-term we deliver phase corporate on and our on next key growth on

each unmet now to Our as value patients today, open joining and needs Thank the question-and-answer again for ask people for the up I you work shareholders. to to strive like continue we high to generate portion us would day and Operator? patients for to call of with today's call. operator the

Operator

Lawson [Operator of come from Peter question Instructions]. will And first Barclays. our

Peter Lawson

Great.

Just II do expect read guess for for should the see? like now versus of and on to looks data potential where -- expect Eltanexor how -- it's we Phase out half see kind data to we first I XQ the much that MDS data

Richard Paulson

it to that. turn to over Peter. I'll Reshma to talk Thanks, Yes.

Reshma Rangwala

Peter. you, question. Thank Yes. Great

patient the very X We hard And need patients survival literature population I than know say high for the population. is overall analysis months. dependent patient that published is very So only much from unmet timing less to to MDS of at term X relapsed because overall upon survival this refractory the a the data. partly very in that year in these

forward. being So signal to identify robust the to survival best able identify a us allows path overall

the it, again, as look Congress still the hard or this of project a occur is patient how terms continue a of is this We'll thing following first through good half in opportunistic forum. company patients. I like going it at some at the It to of we're But present looks point, those be in to Medical this following OS these for way we at data. we only So our survival. But it's data, kind whether year.

Peter Lawson

And then use ahead think about of therapies. as Got BCMA therapies Selinexor we it, or just with BCMA

Just could BCMA you being therapies. if had of used withdrawn. if benefit ahead or GSK's impact the being seeing walk from Selinexor kind potential through And of cell-based then kind you Blenrep of you're

Richard Paulson

I'll on turn interesting the with Sohanya Yes, part to I'll touch that, it Peter, first of kind close looking have fitness. data then maybe at some Reshma and of T-cell

Sohanya?

Sohanya Cheng

Peter, Great. question. Thanks, for the

let question in Blenrep me Blenrep So tackle And in was used focused primarily patients. are you as first. setting. late-line that the fourth know, with line we XPOVIO, to second

continued compassionate on. current their so on could program patients GSK Secondly, Blenrep use continue that

academic now said are we Blenrep some see Having that, to to on country of where of in late-line the are starts materialize new around as starting the XPOVIO. starting opportunities the pockets opportunity setting

gears overall mediated class the XPOVIO. landscape BCMA in and competitive therapies the kind role As the T-cell of into of Switching in

a at increased look we the new as XXXX, been But When into look primarily, year. X% center. class the CAR-T, the setting, despite taking -- we in setting step the all full So performance our grew back for line academic BCMA have late entrants year-over-year. in and at coming the XX% year-over-year competition as when with you the in class, you well in the academic the this grew over

T-cell up in use see space therapy. the T strong XPOVIO cell secondarily, in runway this it to as primarily is continues also have space. Now post value a some leading already therapy using see in to a an a because we physicians proposition academic certain We the setting. academic important And XPOVIO accounts

generate fitness this we more further the strengthen in our as data, Now should setting. academic T-cell positioning

difficult is point that, final types complex therapies certain be of we access. as to these My for know, very patients can

multiple patients rural myeloma patients constitute elderly the example, majority For of which patients. and a

for be population So academic a us target in the will that setting.

as the data work more call year. continue ahead Now this to elaborate we've on got Reshma to story, I'd that planned of exciting on generate for this love some we on T-cell to fitness

Reshma Rangwala

you, Sohanya. Thank Yes.

agents impact in know fitness interested immunotherapy T-cell their are of because want some we They what to physicians not can looking largely prescribe going ability including the really So story. fitness to to the line, to in that later kind are at they patients, get negatively T-cell story they're their very CAR-Ts.

they T-cells, collection. a This important know dividing experience is from them that negatively and kill for which a including patient's class melphalan alkylating Cytoxan and like of impact ultimately drugs, including very apheresis because cause agents damage cells the certain

a on CAR-T, the to get if those these negatively they slots impact Given it Selinexor their to therapies. given patients have going to that they so again, Again, can is ability difficult. want confidence one minimal of again getting is for not slot that prescribe their to patients,

immunotherapies. the doing our that translational can looking multiple environment maximize looking including data preclinical What and assess newer across whether well to sets we are Selinexor as different leveraging evidence is own really real-world data, maintain data that therefore, as benefit at those with immune can they achieve one of

Peter Lawson

the -- of around it Mike, growth, And and there that XXXX great. be would so in revenue you anything terms say is then volume Great. is finally, can pricing, just

Michael Mason

Maybe I'll turn it to Sohanya that. on

Sohanya?

Sohanya Cheng

the question. for Thanks

different of components the kind going So guidance. into

delivering guidance we within our range. First confident all, feel in of

into growth that's shift and new going the pressure As between demand earlier competition balance balanced in in setting we look the into a expansion community it's And lines. at the the coming increased different really academic from XXXX. with from in levers guidance,

to key on This I year. our XX% think remain we tailwinds use a few -- of points last area academic in setting, primary community increased continues focus. year-over-year the the in just grew the

there. we'll we I very and debt prescribers with drive mature to think now base interesting have thing built a this strong of drug the we continue is as

shift line. also We earlier into to continue

will here. help these drive So demand factors to

Michael Mason

will to in XXXX The thing add be to would versus XXXX. guide only that, gross I Peter, is higher we that net did

where XX% somewhere the to XX% expect to XX%. around in were we So the range be XXXX, in we

Operator

of The next Raycroft question Jefferies. comes from Maury

Maurice Raycroft

And paradigm. that you about in treatment the XX% you're you that defined is to I multiple the third-line out seeing breaking you're some going percentage data total? was with how treatment in and the about guess, the is talk to what the second-line frontline I setting. are from paradigm can of prior exactly guess, that ask myeloma that seeing line? well I third

Richard Paulson

Yes. to Thanks, Maury. I'll get that. talk Sohanya

Sohanya?

Sohanya Cheng

Maury, for question. Thanks, Yes. the

rapid area the growth nice third we're fourth to a the see seeing of to our now second factor in second fourth as large trend So is XX% that That bucket upward in know, within we line. that most to that is line of bucket. our we line. And of you third down in focus that third factor. hard our the break see And given to accelerating will exact a patients that that remain the numbers contributing we but data growth is therapy, line in by XXXX, in line know our on line. contributing Little

first increase of in second dynamics that second the the we're we trend the anti-CDXX But in use X in the and the is classes the see seeing major first the line. the upfront. of the and antibody line. an to switching Now primarily, use

is demonstrate As unmet following immediately of in And result, anti-CDXX. is an actively we that growing that manageable generated following XPOVIO where an data have anti-CDXX. the and for to effective a treatment need rationale efficacy

Maurice Raycroft

Got with in helpful. a data? is driver expectations this you growth aligning your it. setting? the key community be your And line to community That's future this third setting, expect behind is And this uptake do

Sohanya Cheng

of drug, Absolutely. they growth tumor know, you off types. line We in these third that patients start see see rapid again, prescribing the when a most as a community variety physicians the the across community,

of they have initial initial them the about really are, confidence build the those initial they hurdles. when across of therapy, now into they've into a earlier given experiences. continuing XPOVIO, that lot of moving any that the come already they So of from And these to and hurdles. crossed couple we a can some new time lines it's start With launch

Maurice Raycroft

too. going Got it. to I question on one And Makes sense. ask Myelofibrosis was

the on from if the mg start and you for with see any need study? dosing wondering II 'XX granularity Phase first on do Just go what the that strategy forward III recommended what data, in Phase you for the to to your updates are and can dose thoughts half additional timing latest dose? data Or the that XX give

Richard Paulson

that you do Reshma, want capture Hey, one? to

Reshma Rangwala

absolutely. question. for thanks Yes, And the

that in The going So is sometime the the enrolled patients, include XX again is of first XXXX. I. patients occur the next to update the update Phase to the just were part as of half

Selinexor Ruxolitinib and them of all all for populations. maturities. treated and again, these were with treatment-naive they're of patient all So the of We're combination following patients,

hemoglobin want XX-week So to SVR, and be beyond. to that time safety going we and that the assess their is key specifically point at TSSXX,

these provide those update patients, can efficacy well. as data, when as as So including as again as endpoints well optimal as continue of to guide going well data to across help follow important it's safety we timing that we subgroup key the data, an translational additional

going terms In we identify multiple across recommended of how II we're dose, to parameters. Phase the look

the see going it's again at So about the week we be to efficacy that XX. specifically

incorporate too. to safety we course, Of data, pharmacodynamic need also important that profile, but

for tuned occur stay update. of first this half the it year. will the So in Again,

Operator

from comes Chris question of next Raymond The Piper Sandler.

Nicole Gabreski

Gabreski This us. is X Chris. just Nicole for for on Maybe

and just just see you The guess, Myelofibrosis, III for can waiting the first, we there the or SIENDO to think second, just from I Phase to should color I particular you'll frontline maybe data have you're year. cancer. regulatory subgroup feedback if Maybe present for as pivotal this with we that a indicated about around that then updated update. some in you the And guys venues order is know study good can what venue just help Endometrial a study? that updated for provide I frame and expect should more that initiate you guess, results

Richard Paulson

I'll turn to...

Reshma Rangwala

about question. sorry Jumping But I'm there. that. great on

the again, mentioned that data from the for the getting that dose. the efficacy statistical So in program, be FDA the plan it's in the Phase next alignment going the just And then, the of Myelofibrosis I and the question, analysis safety, course, pharmacodynamics, III. terms and design the to previous steps just of on for

is the of first look design again first occur forward the in along the with to data in presenting this we And the to then of sometime updated year. that half this trial half going So meeting year.

But I this first-line space. we've got other will say, precedents of a out of terms there in lot

population, to specifically as of the hemoglobin focus at we're relevant So aspects, well. SVRXX profile versus that the a we are pursue looking are XX, patient to points And including then, well important that the and as is to look also at as combination as safety Ruxolitinib but stabilization something likely well. the TSSXX on at week going course, going end that

this the a recent call Endometrial PFS update of on earnings that subgroup. the update cancer, so terms we was SIENDO from In presented important on results an

placebo. we in shows arm comprise for cancer X.X% all same has the What large, the XXXX results. the wild-type most specifically survival median has and patients, November approximately and Selinexor seen XX.X upon now that reanalyzed by months. very we've the to and of based of PFS XX% is progression-free Endometrial median recent increased cut, survival, a for XX.X So from which progression-free those a months the placebo update encouraged PXX updated by now The stayed arm

that now very, patients. quadrupling the by very, PFS observed the for in Selinexor treated So encouraged very median

of We PFS, and follow we'll looking too. at these overall continue survival all also to update patients

look we'll data. those updated accrue, events to those As present

Operator

Ulz next Stanley. question of Morgan The from Mike comes

Michael Ulz

Myelofibrosis the on strategy. one just Maybe

on And you current can us moving are in just the at some the this on then highlighted thinking data maybe based second give you secondly, monotherapy frontline about you your prepared line Myelofibrosis? Just remarks, thinking potentially your strategy of in in point?

Reshma Rangwala

for and Great I ahead to there. get but going was I'm in going question. to wait Richard, go

right absolutely and that Ruxolitinib to So of see the based results our the combination the largely upon XXX focus of now portion we I Selinexor is compelling Phase continue very study. from the

the to the looking trial initiating that with year. in half So and first FDA interacting this then of forward

But at something the cetera. development in we looking whether really that is maximize this want population, to and With learnings that in patient us important patient said, the that the Myelofibrosis, portion novel combinations, the that there Selinexor opportunity suggest a Phase monotherapy, to are an of really important very though, is from I et it's Selinexor mechanism future. that it affords population, define across within fundamental some

now and is Our the of focus absolutely Selinexor Ruxolitinib. combination right

Operator

RBC. question Next from Brian comes of Abrahams

Unidentified Analyst

for I on Joe is have This X. Brian.

data. you the how both to could on terms III from data new you PFS in Eltanexor. shapes also, of latest data in saw would one in you interim first sort that So if the Endometrial the about a cut cancer the expectation the What And demonstrate Phase like and of your more like tell little us and OS.

Richard Paulson

Reshma Thanks, both for of Joe, I'll those. turn to

Reshma Rangwala

Absolutely.

in mentioned the these population. the and with are right, that Phase mean, this the as were Phase So I relapsed actually of as also II part I earlier, to hardest and patients refractory, will enrolled I the months. unfortunately, say short, mean, primary these fact, patient of refractory to published only data in is survival population median HMA are populations. extremely X patient patient I Survival in indicating X treat this I

data Eltanexor the I that With approximately presented XX very We're with specifically the treated by highly 'XX ASH encouraged that patients overall survival months. Phase median was of those we at see we determine this II. overall with patient path best that of population. this to as us improvement It will part allow in survival again, in Phase registration hope the to Eltanexor

results by In increased very now encouraged XX.X that still patient Median Selinexor from PFS the is months to has updated On Endometrial for the immature. terms population XX.X of PFS 'XX Overall, observed again, the November the cut. survival months. from we've cancer,

we're data And current EC-XXX, But the so to very by EC-XXX in encouraged Phase continuing and that achieve those can much data. informed follow trial. this are these our these survival III trial, have benefit patients

Operator

comes question next from The Eric of JPMorgan. Joseph

Eric Joseph

on study secondly, just update. mix of sense of a this on between or cancer. around site will EC-XXX talk you of closely up up patient and extended participation Reshma, about Endometrial the experience regional the benefit Just SIENDO. get One to the interested then treatment of the PFS can line And how kind enrollment PFS? a how duration couple with be lines I'd in

Reshma Rangwala

Eric. Great question.

to going look see an from at we So months. as PFS, months XX.X increase updated the we XX.X

increase We therapy, too. duration that also in see of proportional a

is that progression-free the survival patient So to the not duration, only that going We're PFS but trial. continue and in follow to OS population. in duration this benefit driving

there's is EC-XXX. In terms site activity activation, that of within lot happening a of

we sites SIENDO of approximately ENGOT. included the One add EC-XXX With I'd sites looking that sites. performing the SIENDO. XXX well and as can actually highest identify EC-XXX, because trial from had as activate approximately benefits EC-XXX and experience we can incorporate say sites Europe. sites U.S. to in the into that is that actually additional trial our the leverage the the the We this in XXX them and we're GOG with part of as trial,

Eric Joseph

reason feedback. if starting on should guess, design MANIFEST -- a is Phase how I I I may I'm to design the pending wondering Okay. regulatory could, And the the Got Myelofibrosis. is depending with I just it. proxy good the -- think Selinexor II look? III trial for a trial, follow-up, III should any Phase Phase if -- that guess maybe there's know that III not trial is

Reshma Rangwala

on first interested are in. agencies but key in the interested right? physicians TSSXX about question. points and are I regulatory I line are good Yes, SVR mean, yes, we think know the the also end in,

rux which So right, relatively of we comparison, be safety we endpoints the design going are be and going plus to seli and combination a trial of efficacy to comparing it's in those simple know rux the our the to alone. just

our going combination patients this a to can optimizes very the be is alone. So benefit to traditional to the rux that trial demonstrate but with ability achieve compared

Operator

White comes H.C. question of from next Ed Wainright. The

Edward White

I'm you're -- the give in perhaps and line just times of indication on this duration the of the the seeing what an several patients. quantify fourth that if mentioned increase an last quarter had of quarter versus second fourth to you're the that in therapy seeing in year year. us You you wondering perhaps can fourth

Richard Paulson

Yes.

that want Sohanya, one? to do take you

Sohanya Cheng

question. the for Thanks Yes.

time and that we driven of is when by increase it's takes really duration, the factors in it So are proportion lines to adjustments with staying year-over-year, trend an do it who we upward on therapy dose care. look on longer, this X also supportive patients mature, of duration data management these see in our patients earlier but year-over-year. by in effective at this and driven for And

versus X as increase we see there's XXXX. staying end data you -- X an on of in a in and patients therapy. of patients range, the as out cycles know, In matures, broad XXXX of X, proportion Now the reaching range patients the

years we time, therapy the end the are patients. of these confident see in and getting positions on XPOVIO On managing over do over range, of X outer patients increasingly

Operator

question [indiscernible]. comes next The from

Unidentified Analyst

This for is Jonathan. on

design collected. typically was data that initially if see the differ may couple And second in how XX the was Can is Myelofibrosis we your week by also TSSXX wondering a any expect chart the to first or trials not on elaborate And Just how then do could opportunity? influence your question, update half. review, or then I the that you wondering SVRXX on in may just on treatment-naive for data thinking that from I trial there? Myelofibrosis how late-stage

Richard Paulson

turn Thanks, Matt. those. I'll to Reshma for

Reshma Rangwala

Yes.

So TSSXX talk me let data. about the

the present data symptom have symptom patients to their we'll update, out largely next because forms at a from data in the additional filled medical collected same an opportunity TSSXX charts. also So Physicians perspective.

overview a platforms, these the in medical i.e., has comprehensive X the use really provide the been to as forms chart well we combination. data that of So as achieved can the TSSXX

to this look half So of presenting data first additional that year. the forward in

the absolutely. XX data, terms yes, week of In

So staying multiple therapy. on got patients that are we've

dosed Some approximately patients year. been for coming in. a They've are

this durability data So this again going is for opportunity first being year. an to able half in provide us to of be the

look the terms In our to by don't within mean, decision first-line those but I they're about large, trials influencing I competitor the the data, think design. forward and other seeing necessarily of space, that

to the be is this can a to traditional be very compared that demonstrate to the really previously, want alone. I As as III. combination benefit mentioned rux Phase with We able achieved

alone , traditional on focusing really SVR TSSXX. III very of So be Phase it that to combination and going a is rux

Operator

our like Richard question-and-answer turn conference Paulson over any to to I remarks. concludes for This back the closing session. would

Richard Paulson

thank is you for Thank and call. forward you, teams to you, every near future. organization to day our our sharing people and here the across we can And improve to working lives And and the operator, everyone, us a as huge for all every thank how the an joining on again, you today's Karyopharm look patients of each update say, at cancer. with in person from suffering we once

Operator

attending Thank for may conference concluded. disconnect. now you and now you has presentation, The today's

Karyopharm Therapeutics (KPTI) 15 Feb 232022 Q4 Earnings call transcript