KPTI - Earnings call transcript Q4 2021 | Karyopharm Therapeutics Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning. My name is Sara 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 2021 financial results conference call. There will be a question and answer session to follow. Please be advised that this call is being recorded at the company’s request. to Corporate call Communications. like Connors, to now President, Vice would turn over the Sarah I Please ahead. go

Sarah Connors

Thank you top Richard by Sara, well XXXX us Executive the on financial and Chief III Paulson, as thank you conference Phase Ms. I and Officer; to President all Karyopharm’s call results. fourth and discuss full study, Today Mr. the SIENDO line quarter from today’s results as for year joining joined am

detailing Officer; Officer; Officer; releases, Dr. quarter morning, website Mason, Jatin of the results available Chief releases, call, Sohanya one Karyopharm’s under Mr. Cheng, from Medical we Stephen Business Mike XXXX. two presentation one Financial These today’s Chief Chief Events Scientific study Chief financial results and line and section the Mr. with year Officer; to and press in Commercial fourth top we our issued this Chief the slide III Shah, plan Phase are Shacham, announcing at Officer. the along Mitchener, karyopharm.com. that Earlier cancer, Sharon SIENDO for full during endometrial reference and Presentations

as file SEC, only. forward-looking we views Safe statements expectations for the make candidates, recent of our and regulatory result Slide future. potential Before the X. including including by quarterly formal differ plans on and results These of remind these in which various to of in constitute success our and include that I’ll that in filing today purposes remarks Actual may most Nexpovio, SEC future outlined forward-looking of expectations, timelines, Xpovio as Risk those the Litigation Form forward-looking matters represent and as product our section the with our and discussed our statements may projections, factors, with developments XXXX, we Factors the today other and make the we is materially of from financial our clinical of prospects. comments, important about those of on indicated commercialization products a the relating our statements various the Private under on XX-Q, Harbor will report Any Act provisions you Securities begin statements Reform and

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

now to Slide X. can our If will Richard. X, the call you I turn turn you over to Please see to turn for Slide today. agenda

Richard Paulson

Thank you Sarah, and good morning everyone.

to median to a lives, months with As III hazard on patients survival of a we had pleased X.XX compared very and its for Phase X.X months to ratio SIENDO statistically X.XXXX. placebo. compared in patients’ defeat met the of XX% median representing to primary patients placebo, work end Selinexor-treated X.X and study cancer a of report P-value improvement PFS of a that an progression-free point improve significant of I’m improvement

XX months, of treatment, and in be At In adverse due was patients no to a remission sustained the XX.X% remission with Selinexor-treated long-term standard there in probability FDA patients survival. XX% in a from and improvement on Karyopharm safety XX.X% patients compared will demonstrated complete today’s to representing was investigators data. in improvement a Selinexor an to with to well SIENDO low of new full wait. Additionally, tolerated of Selinexor will increase progression-free no the that evaluation discontinuation a watch events. study, rate and and in work this identified XX.X%, signals or

XXXX. death. the wild-type improvement median an identified at of a sincerest the I patients submit progression-free site, to acknowledge exceptional like In to overview for progression future plan XX.X significant SIENDO guardian medical genome application both sub-group express which X.XX an reduction the Selinexor-treated this from to fourfold also Karyopharm preliminary drive I first a in by presentation or pre-specified supplemental of the the X.XXXX. consisting showed pre-specified a in with of also and half that individuals and especially families. compared statistically very growth. of to data results in of the lot and value months known XXX a the upcoming achieved patients, and done provide for pillars placebo, first to survival of key our the will data pXX, almost sub-group, On what substantial Importantly, ratio study survival a underlying be progression-free their as trial and We the patients currently and clinical our the at disease during for X, to detailed of for we our P-value at hazard plan work of will of five opportunity a the the present involved, wish half believe patients new XXXX I submit gratitude everyone for X.X on will drug the meetings of dedicated FDA months risk the would Slide

product lead net million building growth XX% of quarter First, we are multiple in oncology U.S. our in of fourth asset, myeloma successfully $XX.X foundation existing Xpovio revenue our year-over-year. representing the upon ’XX, as generated

the product we compared ’XX, year year. of net XX% revenue of $XX.X million, representing prior the generated For full full to growth

value to in execution and patients and XXXX capabilities, growing proven through creating shareholders. strong expect commercial continue sales for both We

striving half our Xpovio landscape. have Xpovio Latin America, partners, we the treatment novel review are second in will XXXX. myeloma am the worldwide. line partner to commercialization CHMP that modality first anti-CDXX Europe, become key European for We Menarini global MAA other its the with multiple the the of I a very new standard increasingly an we term, territories establish Menarini board complete on pleased near issue opinion bring partnership during finalized a and plus patients In Selinexor expecting in are Globally, of we was in December. brought care to effective and in of With the second our and to line-plus post as other and

as just in primary with in versus opportunity point huge took survival statistically forward step its XX% a median as a outlined, progression-free end near-term improvement placebo. Second, solid SIENDO significant our met tumors

over we of rapidly science years. areas are that to in potential clinical new probability four pipeline we next three make biggest the a to To Third, high we believe advancing on patients end, in in myelofibrosis, built we of has us difference purposely need, focused and approvals II that the with our where trials lives been the of initiated to cancers high targeting and Phase myelodysplastic strategically where and unmet have syndromes success. have the achieve enables

lives by and our of well cancer. support Peter early right our defeat directors. in fund the of Karyopharm, people our place the Our corporate people, with fourth objectives. strong everything patients’ commercial we executing along is bolstered the an positively we key driven addition focused even are Sohanya Officer Most have further plan, and do is and Cheng of our leadership a pillar ability to to to capitalized exceptional Chief recently, team Honig to board Fifth operations to and on mission to Commercial scientific in impact we’ve into team growth we excellence XXXX. and At the with achieve promotion our and our strategic both finally, with

for global are support technology. and we primed to this first-in-class we strong patients our and in Against to Our backdrop, year allows shareholders begin us organization foundation SINE have is beyond. we this with our believe the deliver and leader a which XXXX SINE

our as on Turning myelodysplastic endometrial by as now data, and our our are of - to X, Slide our well we scope program multiple driven myeloma, syndromes. innovation, range core myelofibrosis, and vision, cancer, focused

to to call turn would for Sohanya to the like As I quarter. we for Slide the the over review now X, to commercial results her turn

Sohanya?

Sohanya Cheng

good Thank everyone. you and Richard, morning

high to important of and growth we across in beginning show to in to the As launch years excellent to progress fourth the efficacy the improve our centre, in once on this milligrams; since make over later continue second now Richard X. On the have Please the evolved mentioned, in to three from slide, XXXX. quarter at earlier milligrams patient two we Slide rapidly a administered turn line-plus dosing right, evolving ways per and lines Xpovio strong how to doses XXX indicators triplet the past weekly on key have a dose left, dosing; lines. weekly to the of XXX twice week lower we doublet XX from and in experience: at from maintained

continue as is guidelines Xpovio of combination in While pomalidomide, the also promote for cycle we life life Xpovio daratumumab, different are This the and and second [indiscernible] to have evolution the to treatment breadth combination doses an is part to, as depth line-plus and combinations cycle. with and of Velcade indication multiple part of approved expand worked Xpovio’s important only of drug’s the and in with we NCCM the rapidly explore we the myeloma. included indication

clear Slide is indicators. quarters, Turning the across now X, to progress positively trajectory and that make continue over to few growth we the it changed key last steady

see the of continue as line the the penta-refractory as space of positive the treatment in a to towards to class white third setting in most journey. continue We shift line Xpovio year earlier second from a to this on our we messaging in focus growth the rapid therapy lines, with new fourth myeloma

strong in growth expanding also the depth of the and with in are community setting. of Xpovio use We breadth

We every and quarter continue to more accounts. increase penetration myeloma top add accounts at

show continues confidence dose positive product the regimen. safety base to experience in our the prescribe data as an addition, triplet in to utilization have improvement the increasingly in perception physicians In and lines sustained intent once-weekly of Xpovio earlier growing and efficacy with lower

see a re-COVID COVID to with baseline, to physicians of the fourth field quarter. oncology on our compared team of level in patient continue we achieved While impact engagements visits high live the

system the added healthcare all our the variant observed January, access we’ve providers. pressure As and in omicron on has to

care a and mid pipeline, to strong and near, We and a XXXX our this remain we of steady momentum rapidly expect and in myeloma in line-plus. as the continue second positioning advancing adapt long to term. will Xpovio continue in growth standard focused on with on drive execution Building to to

to XX, with advance patients SIENDO the Selinexor endometrial will you’ll evaluating to now Jatin in If cancer. call from discuss to I the Slide study updates Jatin? Phase our turn III positive

Jatin Shah

Thank Sohanya. you

investigator from and principal our European Vicky patients well the teams, Dr. as and global committee Trials trial investigator, Kettering, Foundation, First, GOG Memorial the to send and families. to the University steering Belgium, chair, their SIENDO I Institute Oncology as our from Cancer participated Vergote SIENDO in course who Makker would Dr. in the partners, a Network for and of investigators, Gynecologic Sloane the of lead the thank like Leuven our lead you U.S. the and

patients report to the where Now covered demonstrate III results patients recurrent please I’ll patients Slide by advanced in SIENDO had SIENDO to Richard. results Phase remission turn pleased extends positive with Selinexor-treated the am I significantly to cancer. progression median XX recap Selinexor or or a progression-free X.XXXX the endometrial very for an X.X a disease XX%, of of risk X.XX reduction compared of X.X survival of with representing XX% improvement P-value of on placebo, hazard a a months death. in ratio representing months

long probability will that a no this new care XX.X% discontinuation In months seen was addition, adverse sustained low signals of a compared due safety and to patient well on events. XX non with a demonstrated survival remission XX% benefit and treatment, with Selinexor-treated or of progression-free standard Selinexor wait. patient and of as study, in as in term a be to Selinexor current a in increase today’s identified rate watch tolerated In

for pre-specified to pXX, for currently the wild-type reduction or Additionally, survival for of we known consisting guardian in fourfold disease months in pXX, achieved progression identified XPXX. top this the death. data so is out of protein which by of a of is patients with pXX the of unacceptable. preliminary nuclear placebo compared an wild-type a patients the survival pre-specified leads no again to inhibits hazard XX.X again in there sub-group Because Selinexor-treated of ratio patients Selinexor XPXX which data current tumor its accumulation established is treatment of remission simply significant? a significant genome, sub-group, a months patients, showed of the we in a this Inhibition which believe extend setting, median risk on well data Why X.XXXX. pXX, statistically with allows In a is also Selinexor to patients their nascent progression-free almost carry with suppressor XXX the to improvement progression-free of as in X.X P-value because X.XX function, and line time

XXXX. will there with the Slide of is more as for can and patients is you taxane new current endometrial the in advanced As line nearly typically with U.S. case platinum, projected unmet landscape need rates gynecological plus with in response significant treatment on see cases most chemotherapy, high XX%. can than treatment where be XX, in be first cancer It consists The disease. new as common Europe XXX,XXX cancer XX,XXX

However, chemotherapy with for wait and available The watch following a responded approach have the months to with disease typically a those response no progresses. recommend chemotherapy. prognosis progression is guidelines from who poor four approach treatments, NCCM this within until with

turn me talk to let about opportunity approved. call more Now the to Sohanya and benefit patients market back detail can the Selinexor in if

Sohanya Cheng

Thank Jatin. you

front We us. of have a in meaningful market opportunity

of with or Slide a XX,XXX prognosis the U.S. XX,XXX cases advanced each disease and in approximately early of maintenance surgery chemotherapy disease. several those present stage eligible are approximately patients Selinexor benefit diagnosed in front to the XX, being in factors. U.S. therapy with alone, to patients have while and to the are Of enhancing Turning recurrent driving that treated translating those XX% most X,XXX respond, year with up will in line. Further the the good after to opportunity will from patients,

including treat maintenance with multiple ovarian solid tumors, already physicians therapy First, cancer. breast well is and established that

of is SIENDO by Second, today. to the superior in months used Selinexor X.X approach watch and progression-free survival demonstrated wait

Third, and to in has only extend is Fourth, be patients the are an positioned oral maintenance treated the that well response and treatment potential maintenance in that medicine first in setting until post-chemotherapy the is the setting. to time remission. progression Selinexor

patients in strong which preparing rapidly potential a believe belief we become cancer. III and we by powerful affairs women turn paradigm driven to - In advanced in exciting footprint and a is setting, new established a and a short, maintenance shift for medical standard of launch. potential engaging unmet endometrial Selinexor opportunity dire to with an as This has for Phase Slide XX, summary, in has Karyopharm Finally, the with market recurrent an endometrial living significant for or the advanced commercial is care cancer. need results,

discuss Slide programs. to to now the like of Jatin Turning highlights call XX, I’d from turn core other some to back to our

Jatin Shah

Thank you Sohanya.

XX, to our blood are on turn to Slide other programs we Turning which cancers. focused will core now

first has to and Selinexor data track with anti-CDXX where there an proven patients record and multiple is in pomalidomide, manage confident treatment. the in clinical agent include a disease whose strong in demonstrated that myelodysplastic limited There results myeloma lymphoma in focused rates This after myeloma, progresses of single lines at programs in from trials an are is in indications, factors solving carfilzomib data III we how both We generated response and predicting with base robust in lines have that regulatory XX% activity and in of positive gap. hematologic one our bortezomib a least combinations increasing B-cell and goal first a base exception. agent Selinexor and with diffuse with the two therapy as myelofibrosis base been recently is combination data. is large of Selinexor more approvals, and anti-CDXX Phase use, and syndromes. Single of four to no one key has data of In many therapy. growing and

on and and As will study SPd. to or patients up is XX, dexamethasone, the further of our prior pomalidomide This elotuzumab, of XXX one SPd entrenches Phase regimen recruit This study you our who will lines to global be and received data therapy. an study continues triplet of can post the combinations gap EPd to this four versus expected III see anti-CDXX. Selinexor-based to compare evaluates Slide fill and design

[Indiscernible] top myeloma. the the of combination a triplet to and is expected all-oral XXXX in triplet expect SPd multiple relapsed second data dose for with first the approved quarter line refractory during first We in XXXX. patient

based to Turning Slide Boston from authorization regulatory now the both data by and on been study and III application we the under beyond marketing the Karyopharm XX, partners. worldwide on Europe, by Xpovio continue regulatory has strategic CHMP. expansion our access to clinical U.S. the increased filings validated through In the see currently review made Phase is Selinexor global

during first of be to We completed the half expect XXXX. this review

Antengene SPd to partner, on partners, look markets and submissions happen. submitted strategic Canada in multiple through forward file are approval Our multiple or for conditional keeping drug in in you and Xpovio or and myeloma relapsed there for Asia-Pacific also new those for received China, they our on we as updated applications approvals

for Now Selinexor turning improve to JAK-inhibitor review where outcome to refractory potential patients the disease. Slide XX believe myelofibrosis, we has with

There XX, there that’s significant of in approximately Unfortunately, patients not inhibitors. The X,XXX their approved anemia, patients class patients enlargement. and short, XX% class inhibitor splenic these drugs setting patients myelofibrosis, JAK are XX are typically per respond U.S. curative who as lasts not of most once myelofibrosis and weakness, It we response Slide year low months is four working. seen with is stops other is As this have Selinexor. disease with only by drugs of the the on initially, do JAK in fatigue, are those the do for no characterized years. a approved dose and respond. of diagnosed Among data XX% in less promising than survival once-weekly

patients at for SVRXX XX recent ASH at Turning of weeks, for to patients are this we XX% very on patient compelling population. Slide study least in XX, XXXX show achieved that now data results patients SVRXX. and reported that XX% These of achieved

independent XX.X their hemoglobin dependence that an transfusion months hemoglobin deciliter, per time the data with with readout. As you XX a levels of defined achieved On of than grams or either at of the or you patients in less on of XX% as transfusion to became XX of as XX, XX, this a improvement screening, range anemia patients Slide months. Slide see X.X median among duration can see treatment was can

all hundred based physician’s from XX, second data, we was dose One randomize to are patient twelve moving dosed patients Selinexor Top is these least and first recruiting XXXX. line during them in to patients once-weekly months data of enrolled or are at prior on inhibition of this the JAK to choice. Slide expected half rapidly XXXX. trial global and the randomized a with be and Phase expected late trial II at low Looking that’s six and

patients program we to only each with with MDS to of no to Turning the we now diagnosed patients need are MDS. our to are the refractory that novel with very MDS with outcomes four drugs potential agent disease short, survival that XX a progresses There’s in improve currently are Slide clear second show agent. to year compound, and Again, has risk therapy. class six patients the other are in hypomethylating and our XX,XXX outcomes high unmet approximately to opportunity Slide On believe Eltanexor that’s XX, an high intermediate and in on the there refractory the a who approved need line therapies HMAs. approved months. HMA, of hypomethylating Once MDS for is along U.S. improve

I months. that showed In overall of refractory Slide XX, single with six Eltanexor survival study, historical activity of to Phase HMAs. of study Eltanexor overall four MDS X.X our to patients to clear and in response doubling rate Turning median agent controls months, demonstrated a XX%

XXXX treatment nearly Phase observed line progressive we demonstrate to a Mason the Based now XX this well patients in improve I’ll granted Eltanexor note, advance improved orphan MDS. full and Mike response was to top in correlated few study, Also driving year rates that, as strategic the addition, XX XXXX a our designation the that at shows reinforces overall on patients the In and outcomes in ratio weeks to ago footprint, XXXX. II promising new our We reported for as with I expansion turn Slide ASH three Slide With of The XX of expected MDS. to months quarterly Phase for believe of initiated FDA patients months overall for signal compared the clinical over HMA designation with potential for with just a call data hazard for this review Eltanexor’s survival drug our refractory ongoing global financials. disease, X.XX. also Mike? partnerships complete with to median survival. results response the to

Michael Mason

Jatin. you Thank

business Turning commercialization leveraging on now activities development focus the to continue Slide our partners outside United States. to XX, to support strategic

FORUS They This treatments billion a an an Antengene XXXX and from deep the based and to $XX.X recorded addressing revenue XXXX the Neopharm with XXX in additional develop December an growing in In year performance Nexpovio other and one earlier, annual sales. in operate EU-based and gynecologic the Antengene Antengene, upfront on territories. of license agreement receives we and exchange, will the future milestone Menarini of to mentioned anniversary in million partner revenue. net payment Latin the in is EU, whereby royalties Richard $X Israel, partners America, Karyopharm to a on Menarini a strong in over sales countries from bringing Karyopharm $XX As plus million commercialize cash and footprint is deal signed launch. patients in exclusive in over expected developing U.K. Canada, payment million in Asia among hematologic global with their Group to tiered receive adds eligible $XXX.X with worldwide double-digit the Pacific. and regulatory fourth commitment have milestones Nexpovio Menarini With with diseases. quarter

increase XX% XXXX. today revenue XXXX our quarter of XX%. of for The fourth for commercial highlights fourth to discount full in sales of gross fourth XXXX since release the on compared we U.S. of revenue of was million quarter quarter to a financial results, $XX.X was net fourth just for to million to for $XX.X million with the XXXX, earlier $XX.X Total Net the on million issued quarter press year-over-year. the Nexpovio estimated for beginning Nexpovio fourth financials, the representing I from will focus compared Turning $XXX.X a the product was XX. quarter Slide the

on flip our $XXX current operating which million plan, in range as we Xpovio full to million fourth XX% quarter $XX and expect of of $XX the and of operations of compared for to Richard recognized license and product are discounts investments $XXX expecting new now to for turn license million XXXX year be $XXX.X XXXX. quarter the million of our gross year upfront revenue reflecting XXXX, for million to payment XXXX thoughts. and compared expenses the revenues cash, expect XX% sales Menarini. the finally other well the expense million for the of of quarter million the were as equivalents will XX, $XX.X range SG&A growth XXXX XXXX, the to million and million to to to December XXXX. million totaled some of approximately compared to product XXXX, XXXX, including as in cash in our full $XXX cash the revenue of as expenses I’ll to We Based equivalents, comp call the from for Slide R&D planned generate XXXX. quarter exclude early fourth fourth revenue R&D XX fourth that and to net sufficient XXXX. We $XXX XX% compared XX, final and Cash, to million $XX.X non-GAAP from be other SG&A into restricted the of December for to quarter fourth we XXXX. to $XX.X the expenses, cash investments for million for of over stock-based $XXX.X $XX.X be of fund Richard? were

Richard Paulson

very III our the I’m especially plus Phase for and a our strong excited study SIENDO was positive XXXX following progressing about and Karyopharm future, year focused Mike. Thanks pipeline.

deliver patients a strengthen our corporate and with momentum number XX. Slide unmet strong of as maintaining as we need to organization, near are with high on and term continue key outlined to on us milestones for We deliver for catalysts

to we and EMA commercial year, following the first CHMP of our decision requesting in multiple in multiple to a one Selinexor, at dose first and in patients For half from for evaluating striving post Xpovio throughout patients dexamethasone standard care our and with pomalidomide plus with dexamethasone III to XXXX. relapsed capabilities, Phase leverage receive the in quarter, the program, study in the first therapy bortezomib Selinexor, myeloma or the least multiple increase MAA the U.S. myeloma become sales patients of expect line on and and our second prior refractory in myeloma approval the anti-CDXX

to to the program, the is plan we the For FDA endometrial at upcoming plan presentation supplemental first submit drug submit approval cancer study conduct half detailed the plan and finally The pre-launch in a first of for half of to during activity a from of the and of medical launch we results the half new the application ’XX. meetings XXXX. in ’XX, to anticipation potential in first

expect and top top For second combination the the to second myelofibrosis in during program, I report previously in we data Phase myelofibrosis II line line half treatment-naïve treated ’XX, ’XX. JAK myelofibrosis data inhibition in with Phase of report the during of half

the to on community ask I served delivered months our now and trial SIENDO like portion progress forward during open dedicated to Operator? combination top a that, teams, answer continued I MDS quarters to call line you in program, and the the investment and HMA our call. to all preliminary forward people closing, I data look the updating frontline in In with report like who give the first half an II thank data heartfelt rapidly. in I of data Phase and the ahead, HMA-refractory report we would Phase the especially to in Eltanexor MDS in in expect our would up for COVID today’s ’XX. the the of question to Operator and Finally MDS ’XX move to with to

Operator

instructions] [Operator first Maury from comes go question Our Please ahead. Raycroft with Jefferies.

Maury Raycroft

for line $XXX earlier and tell and guidance. is into in million What assuming, myeloma Can your update the and start taking your congrats of everyone, million I’ll anything you are with patients my to today. there morning on you $XXX built XX% the into good growth of what’s Hi, for Xpovio Thanks questions. off going on proportion us assumptions XXXX? assumption durability?

Jatin Shah

Maury. Thanks

Just that going to year, let Sohanya of to maybe to $XXX million $XXX talk for the guidance I’ll into guidance. our million correct what’s and that,

Sohanya?

Sohanya Cheng

very and in feel myeloma best-in-class XX% about of with we $XXX Great, many thanks in which the growth roughly is question. million, Yes, space. year-over-year, Maury confident to line million $XXX the multiple it’s for annual guidance the launches

drivers, far at drove in we’ll There positioning three white are lines, As to focus what it in drivers. and key new growth fourth growth second to and we the as continue strong of XXXX, execution in these space look areas. growth and was the

the into we in is most the earlier where rapid lines, growth third anticipate first The continued seeing the continued shift line.

product shift continuing Xpovio see the this in myeloma into in fastest multiple to growing fact, we was third earlier anticipate and XXXX In lines. the line,

are in half line of fourth in roughly now line-plus. to fifth that approaching and our the half about remaining second then We patients that

The second to the the of increase continue product, breadth our as at accounts. accounts growth expansion and continued depth more top penetration well use our is as we the add myeloma driver of so in

year. to growth that data continue of as to and Xpovio-based growth the the product, for continue the our our third perception in driving guidance building is once-weekly confidence happen. move the key part will driver of The next lower are triplet is the of ingredients dose Those use and to kind on community regimen, needle our shift of intent-to-prescribe the new and

Maury Raycroft

on SIENDO. that’s it, ask helpful. wanted really to a Also, Got question I

population of about If strategy? proportion fit you is regulatory commercial could endometrial that the pXX, maintenance that does your and wild-type how talk into more and

Jatin Shah

and who so wild-type well we we approximately so in population. look study have thanks our see patients patients consistent our at endometrial within as patient approximately of look XX% XX% with pXX pXX, study, wild-type, that, we advanced broader Yes, what much in the with this, have When Maury. for with that’s cancer

have that so regulatory clear the remind Phase to a III I think--I path patient think we to have positive ongoing with comes part that, agency forward the and folks be second for I the study so question label so to discussions continue to want of will of the negotiations. population, we be we’ll discussion overall very have that that, the this for final

Maury Raycroft

or events number you number the arm number patients, treatment about more wild-type is placebo, ratio for many Got the patients this the with it. say still represent for too is just for maturing? study, that and PFS were Also, two-to-one the can a pXX, versus population the clarifying, does in of so how XXX pXX that that or

Jatin Shah

XXX meeting. set at on thing the top those major analysis, so and data so are itself would full same medical the the fixed, that is the so and final sub-group patients, line we’ll results I patients a present based XXX Yes, say for

Maury Raycroft

it, Got and Congrats for taking again, thanks questions. my okay.

Richard Paulson

Maury. Thanks

Operator

Please Our comes Peter with Barclays. from next Lawson question go ahead.

Peter Lawson

Hey, and taking question, my thanks for congratulations.

that On maintenance you’ll the is push endometrial label in as cancer? SIENDO or broader you the [indiscernible] sub-group, going something study, about pXX are the for think a in label we

Jatin Shah

Thanks Peter.

therapies label we as what analysis continue look so full reviewing data has as as significant statistical will a when the touched patients, as this near set shared, on so we we to at term study final and there the that, setting, area these the no with to overall on, do on FDA work and look I be. understand think the just improvement patients data determining approved we’ll the positive engage we the now, maintenance and are positive for need we’ve to this, is other the we in the over in obviously, right at and

Peter Lawson

for it’s a mutant you, breakout and ratio? we hazard or will PFS whether Got pXX get

Jatin Shah

absolutely. We’ll present provide Yes, full the a as we at set meeting. data medical major

Peter Lawson

Got the Thanks okay. questions. for you, taking

Operator

Stanley. Ulz go with question Morgan Our Mike comes next from ahead. Please

Mike Ulz

Hey for guys, the taking question. thanks

XXXX maybe pressure that a from any guidance on should Just in continued XQ? or omicron persists XQ just the here, seasonality progression follow-up in and we thinking Thanks. Xpovio about quarterly consider

Jatin Shah

take do Sohanya, to want you that?

Sohanya Cheng

Yes, thanks question, for the Mike.

disclosing provided million. quarterly guidance. the annual $XXX million of We are not $XXX guidance We’ve to

January sales remain system line we strong and commercial as to our in [indiscernible] drivers, variant so in we in variances the for the execution we given very we now continue forward nimble in strong feel plus. strong to see seasonality, focused providers, to and and Again, patient-centric key and on the performance omicron quarterly leverage moving market year-over-year quarter. as healthcare added digital focus point, your quarters, a laser that far the capabilities, different will As to the on see pressure access see impact positive and did to visits variant, patient oncology annual a of omicron the on of but continue across about guidance on COVID we question has and given. QX on care the in standard we answer force growth To pre-COVID compared XXXX, we’ve second however, positioning the Xpovio we your baselines; and

Mike Ulz

you. thank it, Got

Operator

question Please next with from RBC. comes Our Brian Abrahams go ahead.

Steve

Congrats effective SINE you. you population possible were thanks overall pXX for any the revisit event our the and or population? Hi, to progress, is ovarian question. in Steve wild-type curious, other look cancer, on taking say cervical there and Brian. any the study do pXX, on in and adverse I’m plan the as Thank this the in for to maybe profile indications follow-up, a for a between differences

Jatin Shah

and adverse so full you to I’m that’s we’ll patient biggest don’t is so setting is tolerated need you that we and maintenance though, profile, setting, set maintenance commented of populations is me? was rate, in the the as sorry, along. What’s that think once-weekly really see differences tolerability to which low in we question Yes, something that your those the is that biology data the key, in provide Selinexor we that I move Can two setting. for between discontinuation repeat any well the expect dose in what on speaks XX.X% very event indicator first question low the and first

Steve

Looking the the [indiscernible] SINE with at other in in were that indications SINE, study.

Jatin Shah

endometrial those in and cancer ovarian and two and SINE so the cervical at looking are ovarian so histologies the Yes, other study, endometrial. cancer,

platform. cancer, and our we’ll are We’re upon to endometrial malignancies be clearly myeloma have we’ll myelofibrosis, continue programs gynecologic committed to to build discussions, MDS, key but this four and further going again and

Steve

Great, thanks.

Operator

Morgan. Our Please JP ahead. go next comes from Eric question with Joseph

Eric Joseph

that taken I’m good morning. trend, taking a secondary primary, be appreciating to Hi, curious, relates it end going curious for a at preliminary look the a SIENDO, OS I’m point to whether it’s you’ve Thanks it’s here. as questions. not

gating analysis is part it line primary Just of as and submission data PFS, the treatment to population, and so, be whether what if to end secondly plan to an relates and a might OS the population intent submit wondering be distinction between analysis any of Then would statistical SNDA it treat protocol might package make whether does a FDA. to top you point that reflected set? factor overall in the this

Richard Paulson

planned, agreed submission Number it two, any too and of survival intent to Number with events, for Number survival is PFS, progression-free data an the few by by events too on no, absolutely. the not overall is it’s factor SNDA. one, three, have to survival a presented. conclusions. gating with FDA, to Yes, investigator the make primary early reviewed treat, statistical further analysis and that’s we the overall

Eric Joseph

to for can brand one I about and performance, fourth on how quarter just we follow-up this should how new on be related Perhaps metric, could in quarter, trended the as you great. key were to of thinking the comment compared question Okay, sequentially? and brand, question, if commercial that guidance trending also to Xpovio for third year, part to new guidance just that patients

Richard Paulson

Maybe that Eric. Thanks turn I’ll you, to Sohanya.

Sohanya Cheng

Yes, thanks Eric.

to rates the show also starts, longer we and therapy shift. strong staying because of refill new We continue our showed earlier improvement patient with line patients in on

intent-to-prescribe towards new improvement we our I as three well use, and the in think increased data all the as line the patients, depth refill rates. increase shift, earlier of with of those key move our in into and drivers our XXXX, growth as the breadth momentum contribute should

Eric Joseph

right. all guys. questions, Thanks taking for the Okay,

Operator

go from Jonathan Our Leerink. next comes SVB with ahead. Chang question Please

Jonathan Chang

SIENDO. my Hi guys, on questions, for and congrats thanks taking

are Second what is from you can strategy myeloma in versus you’re seeing experience provide the commercial difference your duration in [indiscernible] of for line in and you there that myeloma multiple the seeing the are penta-refractory you. in lessons any duration treatment? around learned Thank First multiple between the multiple color that question, myeloma, Are a SIENDO? question, treatment success and earlier applicable here?

Richard Paulson

the thanks Yes, first Maybe question. take Jonathan. I’ll

when our SIENDO very be forward. obviously patient with to look still the going regards and we’re much I plans you think population, again to at engaging our action

is about because opportunity areas. to is because first so chemotherapy, line we I a in are therapies to most maintenance in an patients think, by than in approved therapy. no be so talked currently obviously this as myeloma very and real market this itself different are setting, only potential of significant think the different instance myeloma from with XX,XXX markets there there’s front Sohanya those the responding believe different numbers to, XX% We the have I a

is for rate setting, we’ve and a months. shared maintenance the treating shown discontinuation in it’s being the it’s XX also hear months, it’s months, here you’re but XX.X% for as that and in those difference PFS total that population, XX.X progression, through of in we wild-type that Now tolerated pXX the have median through X.X really population the really and well with

physicians, standard actionable excited about for--looking part here, the being watch pXX we in our when to their for people with to on going so engage I are in mutation more do on very are the be it and know our treat patients forward, the need move work we’re it’s and excellent close wait wild-type a XX% we patients move remission, so cancer very but pXX move and well evaluation healthcare patients, and opportunity. The different obviously I study. able really are as approximately of in known forward their point think, which delivering it’s and is well at rapidly The a - status measured, looking very well last established, work-up this and As understood, the documented, looking we and their in continue away following to study, practitioners the and of from are are to of well time which a extend established also to are we’re would results is label. taking able that to teams, approval and potential kind and with

second in myeloma. in evolution of of talk seeing therapy Sohanya For to for turn terms we’re to multiple overall maybe part I’ll about being what patients the the question, on

Sohanya Cheng

effect showing therapy, therapy longer, by more duration Thanks so and better earlier a are on again driven and staying is preliminary shift side myeloma patients management. Richard. Multiple lines that’s data into

early is this line second of data remember at duration to to cannot definitely in important so stage the launch, it’s guide Now, maturing, we’re our time. still plus this still we

dynamic we these therapy We’re see happening phase earlier transition of to use, into population, between approaching third split earlier evolve but lines will second line, XX/XX we as into are patients our that fifth also patient on of to now in lines line-plus lines with longer. in continue in our fourth that and earlier staying we line greatest and in our a growth

Jonathan Chang

it. taking questions. Got Thanks my for

Operator

from question Wainwright. comes ahead. with Please next White Ed go Our HC

Ed White

perhaps the Can has guidelines, thanks for morning, with under the drugs use--the the you how how with NCCM guidelines? NCCM you’re and the prescribing Velcade label the discuss that under with other breaking the Good my taking out versus been is what growth question. seeing

Richard Paulson

you to do Sohanya, want that? take

Sohanya Cheng

that doublets and the overall approved Yes, trend, down, [indiscernible], Xpovio-based and Xpovio this to. so combination regimen it so promote are also and that to combinations daratumumab with remaining But rise on note, point, the there again we or data is there we that XX% as of other data from triplet the those XX% combinations, is an rising we triplet trend with we only indication our to your so other to are Xpovio-based or Velcade use of break significantly, and see rapid triplets use triplets. is from the in it’s where guidelines, an and NCCM that pomalidimide, that overall from carfilzomid, so see, triplet that but

Ed White

taking Great, questions. my thanks for

Operator

Our next Please go ahead. with Lee from question Arlinda Canaccord. comes

Arlinda Lee

duration on maybe the help duration. FDA on then new [indiscernible]? the side, one you proportion, comment treatment, versus in initial my that started SIENDO growth remind regulatory on is and from questions. Can what and ongoing you can discussions what the duration how I for you the have Thank taking sales, the were the contributing improved when versus improved is I is maybe guess for, understand Then was you Hi, it you you. of duration us, thanks trial what can patients? us on another looking

Richard Paulson

to you talk part? do Sohanya, want first the to

Sohanya Cheng

earlier is move on they focus therapy on stay line in and it a a mean do and fourth data these and still earlier patients the the line we’re in is on so year still but that those also shift with data, staying we therapy patients in line shift, showing effect addition, Arlinda. that line addressable remains are lines, second the into is line we two are patients setting. fourth earlier earlier that lines, growth shift, longer longer, earlier patient progress shift Preliminary to seeing but so line Boston Again, guide thanks to phase a management. Again, a establish gradually maturing, But stay is here. our launch, as can’t staying into that lines, into that that’s dynamic better the more driven longer. that are definitely there’s into population therapy also longer, a will patient. it’s for driver can--that side the One got in good by happens hence on duration, we us, than still as larger right, earlier drivers to therapy Xpovio Yes, second primarily

Richard Paulson

address you can Jatin, part question? of the just maybe And second Arlinda’s

Jatin Shah

Yes, absolutely.

We’re from the of beginning to that and agency That’s throughout it’s clear intent is regulatory Phase discussions cycle the progression-free SIENDO. one key with end entire trial, where treat, investigator survival results positive III engaged the primary is not we the report the from continuously, changed. the point that by life and from the and has point and

Arlinda Lee

Okay, you. great. Thank

Operator

if Again a then please press one. to question, like star you’d ask

go Barclays. next question is Our ahead. Please Lawson Peter a with from follow-up

Peter Lawson

the follow-up. Thanks for

in sense use potential Just on combinations, line earlier etc.? way make the re-think endometrial in of pXX that in use does the in or any wild-type you population, the

Jatin Shah

future the for Obviously analyses agency our well excitement more with thanks and question, trials. we around same great entire Yes, dive data that, as population. into pXX Peter. this We’ll as share the that investigator with additional for

Peter Lawson

the trying and XXXX? just Got expense back the--just the What in I’m you, to out P&L. the a question option guidance. stock was on maybe

Richard Paulson

do Mike, want you that? to manage

Michael Mason

Sure.

comp stock $XX expense was million. just Our about

Peter Lawson

And are for break that that would you. population? population, well going a out in the the be--would label that as you pXX wait Perfect, mutant just mutant out and break for conference, pXX million? the to to just thank or on Thirty have

Jatin Shah

that look I presented, outcome at engage It’ll totality label. at think to as the is be and determine data of and a out FDA as at the conference data we the the broken we the and with and then the have look as said, we

Peter Lawson

about think endometrial the we should in pricing How you. Got population?

Richard Paulson

same it’s the remaining price. on to already the going product’s at market, so be Our

think progression, patients, that’s their in key setting where I so the want time extend they to remission maintenance are it’s the really is themselves with through think I thing and at patients very again we in starting perspective, in think talked value - physicians to, treating the and you’re looking patients to from tolerated see look of the at that long to and at in price market. population. about period we’ll median time, t therapy XX discontinuation, market, for at months the and you already those that but will XX% factors, the the as looking over for the one the still that when after important in seeing be at the also of those but therapy, see very when Jatin instance with we’ve hat talked duration long that PFS we’re year total we that’s of importance really same look as a remission real wild-type are being tail, obviously talked pXX of the I we to, a important All look we’re pricing at,

Peter Lawson

you, know the we’re I the we just are doing not final a quarterly but Thank you. about you’re Got that Then guidance, there model? year-over-year or doing headwinds when question - okay. on thinking tailwinds be guidance should any

Richard Paulson

want one? Sohanya, take to you that do

Sohanya Cheng

to the Yes, our key sustain think continue momentum. drivers, we are where I the tailwinds growth really

capabilities, we’ve digital but and execution as the we’ll we but Xpovio our to and earlier, in evolves, far that and as remains strong omicron wildcard line how the adapting positioning strong commercial plus. are As headwinds, to remain I the think second as variant, care I the continues standard impact of mentioned on it of got focus see

Peter Lawson

much. taking thanks the Okay, all Thanks for questions. so

Operator

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

Richard Paulson

you that, you pipeline we ongoing lives Thank progress forward and now benefit trying to continue With to share Thank focus who working and we’re the and very cancer again fighting today Operator. our in defeat to thank you our patients’ participants as cancer. forward call. with Operator, to moving on look to forward being able to all are much,

Operator

Thank The conference attending today’s concluded. now presentation. has you for

may You now disconnect.

Karyopharm Therapeutics (KPTI) 8 Feb 222021 Q4 Earnings call transcript