Earnings call transcript Q4 2022

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Operator

Greetings, and welcome to Rigel Pharmaceuticals Financial Conference Call for the Fourth Quarter and Year End 2022. At this time, all participants are in a listen only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your first speaker, Ray Furey, Rigel's Executive Vice President General Counsel and Corporate Secretary. you. Thank

begin. may You

Ray Furey

XXXX our slides and and rigel.com. Investor The business the News viewed section year release to ago Events short XX can and this and financial end site presentation financial Relations for be end and quarter results update with fourth our issued fourth Welcome on a year while the quarter along XX press was for Hello. of conference the call. in

we Annual and only Form SEC. may that financial subject call, most date, these forward of These a for events looking plans on differ our be XX-K year today's As XX, and may reminder, to reflect are made regarding make outlook our to the and or file of undertake these results ended risks obligation with and from subsequent circumstances. found statements are during as can uncertainties in Report statements on statements to December actual update XXXX, no risks to timing product forward-looking those our cause today's description statements and forecasted. we forward-looking for regulatory recent development. Any A the

the time, Officer, call At to Chief to like I and this Raul our President would over Raul? turn Executive Rodriguez.

Raul Rodriguez

and Officer; Medical Financial Dave our Chief Chief Santos, Schorno, Ray, And thank Dr. Also are today Dummer, you, Dean the our Officer. you, welcome Thank team. our today. Commercial to me everyone, for with joining and Wolfgang Chief Officer;

beginning Slide Now on X.

in forward to business made XXXX. growing momentum hematology-oncology look XXXX. the in And we've progress are this we with in thrilled We continuing our

are ITP. TAVALISSE to with we fourth highest quarter, net patients is achieved in our we for We focusing sales our are growth the on driving making committed the TAVALISSE first globe. And adult available Alongside sure partners, ITP product for approved chronic quarterly international our across product, date. to and sales

Japan's with this congratulate TAVALISSE. important PMDA recently achievement. We step took goal, partner towards them an Kissei on approval Our achieving this of

and are TAVALISSE In commercial the commercial our team, of our operations refractory December are approved team robust leukemia. our execution second on a product with XXXX, keenly drive and -- business or relapse approval AML, we option for REZLIDHIA With acute marketing is treatment and and and in focused two the -- treatment transformed highly launch. to REZLIDHIA or REZLIDHIA. on patients refractory for relapsed strong for team both experienced products, sales myeloid position with a sales launch of we the important an with was the

growing Beyond we our internal committed licensed focus, opportunities. in programs, are programs, to commercial development our partnered business through and

in progress enrollment MDS. continues fostamatinib on risk and Our olutasidenib RX completed follow to And report patients study beyond that cohort the their in we indications. to -- to approved this of in to we opportunities first currently inhibitor IRAKX/X study Additionally, have with we Phase Xb for RXXX pleased are continue lower a evaluate

rheumatoid arthritis a Eli look in advancing initiation of first for our Xa Phase the half -- we of Alongside a first RIPKX to the forward XXXX. RXXX, inhibitor, we in partner, Lilly, are study and

Our four Phase active also in colleagues to evaluate are trial. clinical at fostamatinib COVID-nineteen in X NIH continuing the

of about a agreement license hematology-oncology portfolio the Now few our REZLIDHIA. time on X. from the REZLIDHIA. to a to announcing expanded with we've we just to Therapeutics FDA Forma approval went some want garnered and we've launch Slide short moving spend of months, I talking as then importance with the achievements In

as to turnaround quick as patients testament this navigate hemod to commercial development, our to in company. Rigel's is ability a a this as well and teams medical business commitment Our affairs

in December, say in began And to I our that the for early ready prepare were launch. execute of commercialization work deal the to am we our approval team to to for proud announcing While critical REZLIDHIA. August, despite on diligently priorities the

efficacy the and made Advances the we and AML. REZLIDHIA the since registrational educate by approval, opportunity Phase guidelines the at share and Phase X in profile. U.S. in Also to medical has or community prescription of in meeting. available engage had study. its from well term the after REZLIDHIA relapsed X safety We to December, for and AML the ASH registrational characterized new study Highlighting durable were refractory XXXX the of publication highlighted in with longer added Shortly NCCN data then the been was Blood able to the

of REZLIDHIA pleased focused on with the that launch. are While the success so far, commercial continuing we with execution

turn quarter. the for with to the I'll that, over Dave Dave? of call So an overview

Dave Santos

Thank you, Raul.

I'd take the a our first to and three growth transition REZLIDHIA progress record few of like during in to to launch of discuss our with a TAVALISSE months continued Now, then minutes QX.

as is see Slide you with On susceptible mutation approved patients X, adult for will FDA detected FDA test. indication, an a by refractory our acute approved IDHX myeloid which leukemia with or relapsed

die American XX,XXX Society the that X, patients more this Slide about will And to will in than disease the XX,XXX Cancer year. AML with from diagnosed patients be Moving unfortunately, estimates XXXX.

refractory IDHX lives of a new impact AML refractory are In the patients to AML near of years. two within of two to year. and patients, X,XXX the unfit in progress that IDHX showed us X% positive, IDHX or up term patients opportunity terms for of XX% the relapsed gives mutant our refractory patients years setting research that around in to or most eligible positive each With patients, fit relapsed or relapse X%

a durable responses space. the we that the has It relapsed/refractory slide failed therapies. previous patient has needs in patients shown is On believe XX, mutant to address key treatment potential impressive IDHX many have REZLIDHIA who targeting and promising new AML HCP in

with They agent our in years. see refractory two Combining XX% of review the CR, treatment and REZLIDHIA their that refractory with CRH relapsed profile, safety of exciting CR, well cohort, a IDHX continuing the rate more rate population AML cardiac XX%, of value in duration adopt looking forward we their As armamentarium. to more that monitoring, response in patients. the of without leading especially to Overall, it characterized an see IDHX even requirement are of longer the relapsed for clinicians and pivotal mutant to complete mutant or relapsed a demographics potential becomes efficacy continue REZLIDHIA market our refractory patient of execute and become together median launch to compelling put to AML CRH than a a treatment like in the plan.

accelerate pleased our commercial of quick a medical treaters, to who Then the worked product our our important publication distribution Moving bottles our December our Society the momentum team critically the members a network through teams approval have ensure great for done among XX, stock on for for job to educating XXth patients, up patient. hone later that and party AML through the to two access team American and and upon field meaningful launch, holidays third It continue plans over Immediately affairs to teams. was network and XX, leukemia REZLIDHIA Slide December to first just raise first website online had Hematology have our availability timing over in on awareness our attendance. prominently together our launch ended, to team closely executing our important Annual a It and And with were account with references year at field end quickly our of to team week was December our available launch we X, customers product were booth, as to Meeting customers out shipped days interacting extremely several December week of available X, XX, and was XXXX. announcing ASH after our distribution for and on on we within perfect messaging. marketing patient materials approval few an access end. way was an finally, a us

by IDHX experts and recognized as for critically quick therapy prescribing medical On disease for progress or include Slide this to to olutasidenib January see guidelines recommended and delighted practice prescribers. of an the panel key front NCCN relapsed we AML targeted that formulary will strong with we into On you This were GPOs, moved the New is payers, continued by we a unanimous the accounts for mutation. Year. affairs as make decisions updated XX, clinical decision other were refractory and important that XX, on

We will Also in important claims messaging. first our through REZLIDHIA in coverage to confirm to recommendation our highlight paid patients. continue pleased January, this we for were

hurdles to and to with everything maximize continued We GPO reimbursement access individual as to they that well as work key accounts ensure patient payer prescribers any minimize they REZLIDHIA. need and have to

conclusion states patients manageable in safety with cohort And remissions with a Phase in remissions Blood with in olutasidenib publication the and induce respected to The population publication, which REZLIDHIA for well-known and reference credible clinically this therapeutic soon and third come. will meaningful with efficacy last of IDHX or monotherapy pivotal AML poor from represents relapsed years our independence continued characterized profile. advance that options. party IDHX February entitled a refractory prognosis another refractory launch is among data This in first complete a our patient with patients induces The limited well defined durable peer in olutasidenib important highly transfusion AML. Advances will molecularly or for mutated online a treatment is and X the relapsed durable appear month, that observed momentum be print review and journal mutant

met few a in a knowledge build had just for the entire commercial weeks our foundational team's productive team person upon finally, on our annual and medical approval. highly We affairs and meeting And continued to meeting. ago, established

we our look next awareness as providing more journey. Our of our team than meeting spreading to updates that left accelerate we launch. into as ever phase move REZLIDHIA launch continue and forward REZLIDHIA to of uptake continue prepared I

comments our with Now, to is immune have had previous few who've treatment. response On will for progress adult approved an Slide insufficient onto in chronic ITP. thrombocytopenia TAVALISSE FDA or on a of a patients XX, our you CITP, I see TAVALISSE brief QX. in indication, sales growing which

thrilled clinics, starting last was more bottles report am to patients representing new again happy we XXXX XX% starts TAVALISSE that growth XX. This quarter year. any robust announce I than years in our more launch. to growth am had QX by to patient XX,XXXX and shipping I patients since Moving TAVALISSE. new QX, best of in other driven that we to ever over Slide had

more than or million last same representing QX, we $XX.X the quarter XX% achieved year. For sales increase net million, of $X.X a

with solid sales. in pleased extremely are the are we how year ended XXXX growth we over We year seeing ITP and

benefit continue saw identify can appropriate our focus clinicians beyond starts on we the grow to patients to XXXX. levels in will We that from TAVALISSE. record To targeted patient new

milestone expand to in partner our for globally regulatory patients Japan, continued a chronic patients And earn Thrive in partners. finally, of around the to globe the on through remain XX, TAVALISSE update Slide we the ITP. to PMDA approval. commercial how continuing December, to footprint with We announced I TAVALISSE's to you are of CITP for Kissei, In on with for impact access million $XX committed our wanted with continuing treatment TAVALISSE. approval expansion

Thanks progress. Wolfgang? to development for brief the And turn call attention. I will now provide update over a to our Wolfgang on your

Wolfgang Dummer

will you, lower start other briefly programs. Thank XX, MDS. Dave. I summarize risk me Slide with let our

Our cohort Phase first the study now inhibitor Xb MDS to Rigel's enrolling escalated in X/X IRAK lower RXXX, patients next cohort. dose evaluating and into risk the has enroll has completed

well have So of events far, drug tolerated seen. was and been adverse the no concern

We as the establish in level study. to well RXXX patients and this new design before additional obtain a further patients lower preliminary RXXX to three-by-three to MDS, efficacy with to look recall, maximally dose to treating dose a tolerated data, you study safety expanding forward risk approach escalation information. investigating As may represent as promising uses dose believe a the

of On our ongoing overview programs. Slide see XX, you can the

the primarily on slide. on previous on regulatory RXXX just our opportunities refractory development our evaluating partners risk that continued trial we As I X evaluating and AML registrational and includes their We're MDS look AML beyond starts relapsed This the I patients lower we took applications additional focused are odevacitinib you the and everyone mentioned, It like clinical to includes in other progress also business. Raul programs. success. ex-US for through to fostamatinib with trial. forward also Phase to globe. or Hemog remind to of bring building from around growing internal this the analysis olutasidenib, REZLIDHIA as cohort, cohorts the

RIP X active and in enrollment kinase RXXX capabilities. the as evaluate in Lilly study COVID-XX. assets continue continue development they Phase fostamatinib our as a to efforts, our with inhibitor towards NIH four X in a for study continually arthritis Phase license evaluating advance work these the new internal Hemog that we with potential leverage treatment rheumatoid Supplementing to can More optimistically Eli to we

That development turn will Dean? concludes summary, over I my Dean. call and the to

Dean Schorno

Wolfgang. Slide XX. on you, I'm Thank

resulting TAVALISSE our levels clinics, XXXX, to million end our of were the of specialty bottles fourth increased X,XXX product distribution shipped remaining channels of patients of the For sales, the shipped $XX.X XXX quarter distributors, gross the those for bottles X,XXX we of quarter. and bottles while in in at

in Following net We end of the to XXXX, XX, the $X XX $XX.X the of reported sales product December our million a specialty our at Two sales. in product TAVALISSE patients channels from XX% same fourth reported of REZLIDHIA million while increase fourth to compared to net sales XXXX, on the quarter shipped product $XXX,XXX commercial launch XXXX. of of we of bottles bottles REZLIDHIA quarter. from REZLIDHIA REZLIDHIA shipped We of period XXXX. quarter distributors made the of resulting in of XX bottles were in in our and clinics, were gross distribution

product net for other co-pay respectively were million the XX% of recorded chargebacks, $X.X was and rebates, net gross quarter adjustment XX% gross and TAVALISSE REZLIDHIA product TAVALISSE sales and REZLIDHIA. net fourth XXXX, For sales approximately assistance our to estimated of discounts, Our of from allowances returns, of

move review me product our expectations first the quarter for on let sales, from of XXXX. Before we net

the small quarter TAVALISSE. XXXX. with clinics this expect issues start the such increase quarter fourth as compared co-pays the quarter to to patients shipped as of the typical me confronting Medicare in Let industry, to Despite of and and in first the of a resetting year see we hole, first bottles donut reimbursement our

We see to and growth the bottles shipped continued expect year. clinics patients to in throughout

as and we months you of REZLIDHIA, still a couple know, For our launch. are only into

initial having by treat AML. patients As Dave who team highlighted, our physicians with with is we're encouraged the interactions that field

Rigel With progresses. increasing forward awareness for patients year expect see penetration we add new our these our and progresses. approximately of market the REZLIDHIA and into XX% We gross we interactions quarter and we this as adjustment new Incrementally, specific to REZLIDHIA. launch the to of expect currently more providing as net increases, look XX% approximately updates in first TAVALISSE be to future the for as for to XXXX for as

were contract next revenue collaborations XXXX. revenue our treatment of net the $XX of $X contract collaborations revenue payment revenues of Kissei slide, approval related sales, million $X.X million from in earned $XX.X agreement their to to our collaboration PMDA government milestone upon consisted and agreements the and from Japan's quarter Medison, was of Contract product in On chronic ITP, TAVALISSE to in related from million in for with revenue million from non-cash fourth in addition with Lilly. in to our $XXX,XXX the license $XXX,XXX royalty from Grifols, revenues revenue

and cost Moving on to expenses.

the of for product cost approximately XXXX. Our fourth quarter $XXX,XXX sales of was

and the were Our XX% on inclusive in quarter fourth and net $XX.X cost cost million million sales to XXXX to and sales. the royalty product personnel quarter costs was costs expected in were costs same our of inhibitor research the of of increase for REZLIDHIA primarily expenses period a with program. $XX.X product commercial versus Total expenses development expenses, related along and This higher related XXXX. for the IRAKX/X in due

towards currently look expect our full cost XXXX be we approximately for we total $XXX of and As expenses the million. to year XXXX,

Finally, million. we term short with $XX.X equivalents cash, ended quarter investments cash and the of

Raul? the call that, With turn to back Raul. over like to I'd

Raul Rodriguez

Thank you, Dean.

transformational we of for a for well in that year call, positions believe us execution this very was As read on year this we XXXX Rigel. XXXX. And a

Our TAVALISSE commercial and with increasing focused force interactions. our expanded is accelerating sales organization sales on

as prioritizing our physician commercial we launch and identifying For collaborators. adoption, well as are awareness ex-U.S. continuing and REZLIDHIA,

evaluating across forward new supplement leverage capabilities. to progress and partnered Hemod continued programs, assets we external our development and to growth, look commercial our initiatives To our while business

this very commercial initiatives excited are in clinical We our about about XXXX. and and

contributions at final to search we service March a On behalf Currently, our to new for with a and that experience. like your for of recognize to will moment you on note, our I'd a like to team, stay CMO Rigel. a take last XX. CMO be thank are Wolfgang's oncology Wolfgang, conducting hematology, Rigel I'd

in With quarter in throughout questions. if thank fourth for open that, up for we can to the XXXX. you progress and I'd our call interest the your like Operator,

Operator

Instructions] time of Nochomovitz Thank question-and-answer comes with this gentlemen, line session. Ladies the and proceed question question. Please we'll Yigal [Operator you. at Our a conducting from first with be Citi. your

Carly Kenselaar

Hi for so team. is Thanks our Yigal. on Carly questions. This for much taking

have We early, you very obviously, it's a can first, concentrated a bit I base here? comment on is are the but about script actually to able few guess prescribers talk on so prescriber And REZLIDHIA. you have many written a far? unique still Thanks. how how

Raul Rodriguez

I'll so ask comment. you thank much. to Dave Carly,

Dave Santos

Yes.

part second today in going the QX. not we're talk your on it's Carly, of because So, question, to

you QX call. that from we'll know, QX those As share are results on our

and we about specifics -- that the group. those we're leukemia prescribers. more half on So half TAVALISSE awareness on specialized who I about, in a since in to those since prescribers to we've leukemia. really share we've difficult for of that targets there little won’t And are this About that, people are calling of But December. treaters, as X,XXX talked AML are access, now are been and it's continue grow are been consistent only about our at a say with will But us. that A confident progress will targets. we're we've be those and we're that challenging, we making more bit can difficult especially as

Carly Kenselaar

bit be during And during inventory the and you quarter That's disclosed quarter. the quarter Okay, dynamics that talk about great. shipped can just second stocking then guess of bottles first about should a thinking the you fourth helpful. I XX XXXX? we

Wolfgang Dummer

Dean as or ask stab Dave can well. Carly, I a and to that take at comment

couple all of terms that. channel. And have really we in Where of months beyond quarters the better that a the will were two into don't yet. XX into those that sense a stabilize? We now, the of but know So inventory,

definitively New still dynamics but so -- may is there a end institutions or even from early that still are usage for given been but in inventory, product, are terms and stable too up. say bit something do how the little that of early it's know it ordering has inventories We us. to in a trend unknown

Dave or comments, Dean? Any

Dave Santos

we Carly, go have orders only patients, thing -- we network. that distribution SP entire would chips to directly distribution an have our I accounts. and to then is say, network that The we our distributors And ship seen have Yeah. our out from is

who the SP and So shipping that hospitals to as are shipping is to well the patients. distributors

Dean Schorno

one just launch TAVALISSE REZLIDHIA that, one REZLIDHIA, for two is is we And detail week supply bottle is as one month one bottle. supply

worth So of as we into translate bottles those XX months’ worth of need to treatment. XX

Carly Kenselaar

got timing little you've REZLIDHIA. last the bit opportunity think on and you frontline a that past potential Okay, potential then just study? And is, for you for Can thoughts our about registrational I AML with talked talk it. question the in about stand where

Raul Rodriguez

Carly. best of opportunity molecule think Thank within REZLIDHIA that opportunities. you, gives us it. of that best setting. has a IDH data, some has a it's that data And We shown I think lot the tremendous in the relapsed/refractory

diligently there clinical outside FDA. are investigators there's are quite go KOLs, of potential things take decisions understanding well opportunities, up AML segments that fair there's So And these AML opportunities it. of both working potential and amount where the various some segments interactions looking as in there we even, with of well. as as because of And a we'd number at we're like to with and

body effort that is of effort, And that underway. so

be say, I speak we timing say might few the things to when could a you or can little Wolfgang. a bit maybe Maybe ready about

Wolfgang Dummer

study at But because and do then numbers. has analyzing past, scientific brought you, patient think one want as option patient target the are today, I earlier, analyzing I the share definitely just is [Venaesa] this experienced to meetings. have appropriate one fully you with options the our (ph) of population, we considerations. can’t efficacy say, a have population I of we and up cohorts consistent several. I that you give would I shown very don't both well and with population present actual mentioned been the other from it are in that is it as this first as numbers we that Yeah.

Raul Rodriguez

come that terms only the this year, to Craig, to you in of to thing for to sure, add of terms do timing. next. like what in we'd back we'll Later

Carly Kenselaar

so you our much perfect. for Okay, Thank taking questions.

Raul Rodriguez

you, Thank Carly.

Operator

the question. with comes your next from of Jefferies. Our proceed question line with Jan Please

Eun Yang

you A of much. Thank questions. very couple

you of cash $XX the and So end in since had at million last this you year about than higher cash burn running year for that.

how and about this you operations So number That's can beyond? you question. for one the talk fund year

the now fostamatinib. mentioned of looking reach profitability? you would question with some do opportunities have And when last is, Second on of question the be kind you other for products is, market sense able into evaluating you two to my

So considering? the you can you opportunities talk about you. other what are are Thank

Raul Rodriguez

Thank you, Eun.

the to Dean and the first address maybe Let of me two address third. of questions I'll ask your

Dean Schorno

Sure. Hi, Eun.

So I here. both together your of I'll questions address think

as Incrementally So January, in we million $XX cash, noted. XXXX ended from with million you of received Kissei. $XX we

achieve business to business the flow And we efforts So position that cost with over efficiencies really profitability, a the leverage on you've focused we as really year, path some that the in discussed company, today. to cash have as -- we've a and our established with last as for described made is Hemog we to respect we're seen do today. business priority our it comfortable breakeven. We cash the current we

in over reducing to numbers non-cash, $XX $XXX that are our and I are million we expenses operating just would we this the to described I XXXX, $XXX million expect comp just expense about stock are year. be We the reported, down depreciation. note what operating of about from they million

to haven't So then breakeven, getting with respect forward, as given to top we our we guidance on line. look

in in really quarter continued run look TAVALISSE. that's at exclusively $XX in sales run million we that quarter TAVALISSE. got reported there. we growth We've over revenue And weaker expect about at be REZLIDHIA we and Incrementally, growth as look can't But XXXX, to in on top fourth almost the that's we'll rate. we plus our line, we million, fourth rate results when time, get breakeven. of So just specific growth as $XX

full And can continue expect REZLIDHIA. new opportunities. revenues. be existing revenues, collaboration for now couple the revenues net ex-US And rights olutasidenib from from be they Lilly, we've we of seen the opportunities over revenues expect have to Kissei, We examples collaboration Grifols, could as collaboration for of like then to be time, REZLIDHIA would partners year. And new also revenues those

partnerships well X/X potential IRAK As as for Wolfgang that program describes.

So set been progress launch but into focused the to on the we're haven't specific up certainly it we on get pleased made the time and we'll year and with as we've breakeven, over XXXX.

Raul Rodriguez

Thanks, Dean. shipped It's worth QX. so noting, in -- as bottles positive. increase Dean seeing said in quarter to TAVALISSE downward been small clinics. drag very in has patients his we this and a a We're comments, Usually, and see actually we're patients of far seeing

best Just quarter always growth quarter some to that. our quarter first seeing quarter since be of our given launch. quarter was challenging. QX This best since our remind on you, quarter, that our will oddly, not QX, top we since launch, best launch, is last QX QX are best

focus expansion very TAVALISSE and the a our commercial QX So a and that's sign positive some to despite increasing testament from sales headwinds. in of team

information opportunities for We're at opportunity little your versus question On press Eun you may put the other a on host. bit looking graft was release, in opportunities third other in we fostamatinib. see as of

data is but because done there and that final compelling. is the thorough We haven't opportunity, quite it on the seems diligence

thing might foster. So that's one consider with we

and dollars to limited the and our want at between look invest they're have infinite, where they're totality not We fostamatinib. of olutasidenib clinical we to

launch later year back and you those for with this going we'd we're drugs. decisions like terms then of make come in to to what registrational trials two to these So

Eun Yang

hemolytic you one quick Can are revitalizing indication? warm about I follow-up, thinking ask anemia you autoimmune the

Raul Rodriguez

would FDA a is you de it in that. might substantially interactions question. And -- trial, had maybe We less our prior that again. smaller trial thank be not than We've Yeah. with novo little once what necessary a but I and think than that for be

be And priority probably given, have but those that anemia. both in so, the of that that sizable opportunities now frankly, we with rather front olutasidenib. than hemolytic given and also warm fostamatinib, opportunities us would Quite with autoimmune other

Eun Yang

you. Thank

Raul Rodriguez

you. Thank

Operator

with Our Sandler. next the of line question Kim comes your Do proceed Piper with from question. Please

Do Kim

taking and by Hi. having of kind questions. reason? any of hoping a their REZLIDHIA willingness Anything or for Thanks feedback anecdotal? use any to docs, initial for to if I any you've enthusiasm sense preference was my And the for pushback drug? seen TIBSOVO get for physician

Raul Rodriguez

Dave?

Dave Santos

I morning. here's customers recently as [indiscernible] this could anecdotes just At I've out actually as give of flew yesterday a you the day, for end back things a been couple lot just the of with you.

when truly data, First are to you begun the if we of haven't the there all, this which commercially survival yet at about and look Advances talk in is people things publication, even Blood that understand data.

put this more very of have to People it, something in here. we -- talk a and look you published. take If responders piece which at reached, kinds my Those publication to CRH not was new since you the begun clinicians fact do and patients CR, that's and recently of data is XX it's we what there pieces much of this surviving. kind just it you see become that and the as the survival of yet of responders, terms about that the that in are that survival, begin convinced months, have XX% more doing

We And have -- been you these go it that I you clearly patients. we that and are But then and when data, and passionately put response can an in say, out recall a talked CR which is to relapsed/refractory right? at is look But about when response is kind when that, people that CR, what impact. do and there to the that's context get. at have have duration really rate with rate, clearly yeah, people CRH rate, of that a the high XX%, can which XX% at

to And [venetoclax] we were publication on clinicians two, Advances duration. fact two address trial the are had me there talk you number also to yes, then same, patients to that really one. to the be think to So are look to going in the that too. that are but have we it's And to into dive Response really who (ph). the say survival, come rates able about able who Blood on things number be help the

are publication going that January augment addition. those that lastly, help And continue things so just just to to though, NCCN And to Guidelines story. going the we're in our are the gotten in And are two do that. we've

a have As you the links NCCN and the both website of Blood to look matter Advances now, announcement fact, at our guidelines publication. if we

I So that them, think I those But how move far, depending two them. move. will things the clinician much get time say, help are we really can critical and with we on so would

among the this I have also remember US. top is at in that X few study treaters that you And just that say will was a leukemia to institutions the country, done Phase the very in

haven't So had a kind people all lot chance to of product. a sudden. it use And came this on a of of

matter a about December. talking aware was with this it even in then that And last fact, it a some They was weren't filed. night, was As I all clinicians. of sudden just approved of

this we the going key of so, get. is thing. awareness, more especially to that we're feel raise We adoption kind more Do, the very And firmly, treaters, among the leukemia

Do Kim

to Thanks, That's great hear. Dave.

you on Is force? estimated the your earlier Congrats sales. share you, you're on but for sales the have TAVALISSE. TAVALISSE penetration on Can formularies? driver And what gotten of the you accelerating the getting the now? expanded sales much is seeing it Where these it is product question about lines? market Is growth? Another talk in of

Dave Santos

part question them, of if look at -- take I'll So your that first. first that you last

line of patients our of It look up percentage have data the good it at pretty more of you actually second patients a look now. we through If through quarter right in patients that our TAVALISSE. a at makes our OneCare. on are patients Rigel look our on If our disease. than product We we at actually and

continuing making progress a we're the beginning the the start brand, But of out to patients customers interest for of mean, are you I in on there driving to Again, in They it. kind to of And new cases of have get people we it's therapy. we believe that website, seeing terms really looking their get go use earlier we're of at to over of are are the patient know they of we patients lots do you what's to this a our lot very we day in folks TAVALISSE. that all messaging. see lot. more and again, in just sharp above. the So lines weekend, new and drug if end

drug. above. also had the access isn’t more the we've really of to believe I we starts work year talked hurting; all to of way, the certainly done it's but last the have And about, by than had contracting we we've we've only the believe do direct result a access not raise So commercial awareness of patients that's the And that do before.

due that. Raul that So, believe where over looking sitting as slow things at get to the reimbursement the And as patients [indiscernible] March. we're making whole mentioned, and down QX toward a to is part we progress here, we're of start Dean and bit your goal in normally here and we're hurdles first

and access team difference searching all picture that painting access it's things, have but time, taken and just it's that's every to drug. there really sales for hard patients they're clinicians, So I it especially the give patients making for of new those some day a out our team patients, and though, to ensure our to so worked market that commercial has really and

Do Kim

on thanks the my Congrats for taking progress Wonderful. questions. and

Raul Rodriguez

Do. Thank you,

Operator

with from of Fitzgerald. the question. question comes next proceed Our Kristen Cantor your Please with Kluska line

Kristen Kluska

taking Hi, good afternoon. Thanks for questions. our

data some this on earlier year. received following you had the interest program we've the So inbound cGvHD

the this opportunity? as what potential question then, conduct market as is, what you to the considering whether And to you are population? look So patient view do further studies may factors in you

Raul Rodriguez

the stab at drug. your you that, We're as you're study patient landscape things new the to pricing the competitive look That for indication by presently, indication, and as anticipated file the to potential Kristen. at the competitive landscape approval, comment as Wolfgang and the when your at time Thank complete current variety of looking at I'll fit that. you the like a and whole the well. population, looking take things ask you, includes for well

to, thoughts from obviously, that things when sites possible on interest KOLs So on and in addition consider there's as do quite a to as number well FDA it. feedback to do your you that of

they you their should studied things know. sometimes on own views have how And be as

So it's of terms frankly, doing decisions, complicated study. a in

Anything to add? that you'd evaluating specifics it. else on actively the are opportunity Wolfgang, like we of So overall.

Wolfgang Dummer

numbers. have the seen paper the just paper, you since Yeah. at look Maybe and obviously read you the

available first them approved is that course, numbers Of and are with look the compounds we other thing now, do we compare compounds. right at these

-- over high. have year the It's seen rate pretty response You will good. is a that look numbers the overall

So favorable to currently approved drugs.

future So how have then What's will on we can And impact an be on opportunity, much look FDA in a lot is too this cost timelines. But now. What's do that will as how and see we also the market expensive do have be? with to not like. it And size? tell the how of exact sample sizable distant could quickly to we work to And right And potential. we what going as registrational far could a can -- see the a that? design? from a trial opportunity

Raul Rodriguez

think us that as sets And well. I

Kristen Kluska

for you're Eli to ex-U.S. outside your partnered programs of for in you some out what appreciate including partners? Lilly that. your it. looking then are Thank of Okay. things I partnership, the the related And key XXXX

Raul Rodriguez

Yeah.

know you as to through they're very the at to and product I’ll have to the available approval Japan. So working the now -- TAVALISSE, soon available the commercially that. or got regards They get progress, pricing, of end good on which year With now. be handle in

to as the all forward So available It Europe, look is Europe, Canada, in countries as Israel. in major that. well

making so, with partnerships, TAVALISSE. terms are good very of I progress in And think we

olutasidenib. with discussions having are We

the part we as well. opportunities As to are rights license, global as U.S. you and attractive know, olutasidenib, of have the ex

in we with discussions partners are So regarding potential that.

their be, might contributions And clinically of what also, but the be. also economics just not what might in terms

said, that we than very that are in AML partnership of be will program, help there's data, of the have us. also in in not having explore those And rather their think various IRAK helpful opportunity it's interest the contributions place hemic generating which And to are us segments just indications we that program. in in tremendous financial rights of in and attractive interest place. a then As program partner regards that we're is a very much you to can interest. a terms to of possibly global setting But

indication, Phase And competitors because data and to with entering could a in Phase think may Lilly very this currently rheumatoid which program available one we're new a serve with other arthritis. continued meaningful RXXX in a to our arthritis. So systemic study Xa in it's rheumatoid new show a we're development, testing We're the as in and and forward in Xa the indication, in kinase progress very things for about collaboration, study handful of we'll data We And need get next treatments. that. cross sizable great agents that product launching arthritis partnerships. then to their in product looking a be those months, with excited rheumatoid excited attractive about

we program the move associated into humans. also with that CNS have a And hopefully near then in future that preclinical development into will and

So very current progress a good and to putting currently looking more with good with marketed forward collaborations, products in progress very couple place.

Kristen Kluska

Thank you.

Raul Rodriguez

Kristen. you, Thank

Operator

next question question. Capital BMO line Gary proceed with Nachman your Our from of the with comes Markets. Please

Gary Nachman

for me A few on REZLIDHIA. more Thanks. afternoon. Good

and then test in patients? hurdles? just far that And How You for common these a is for minimizing patients? your it more you mentioned there for is much access use little reimbursement that. is like bit then, force mutation AML Is physicians been are in penetrate some issues sales prepared the in there being do allocated easy an REZLIDHIA? So challenges identifying what And for are so specialist And a to You how there. further Maybe that that no mentioned how can And what remarks. the TAVALISSE? practice? REZLIDHIA? to else between diagnostic IDHX REZLIDHIA leukemia you on

Raul Rodriguez

Sure.

take you list I'll Dave, you. one, remind to I’d ask I you, So, ask if those I'll missed you made a that. of in --

Dave Santos

Yeah.

first, the take last I'll Gary. So one

all, matter of first it's time. of think I a

these of institutions these to cetera. leukemia a there, see them, et while takes get treaters, as in make Some for appointments, it

got departments. You've hole

You've got MDs. not the only

practitioners, you to You've need see. your nurse got PAs, fellows that

all working treaters. members into we're and terms So getting those commercial out other work we have together team of across medical leukemia see affairs. of angles also there. But They field in

and field are MSLs are reps. they the territory If introduce partnering able vice know business with our to they manager versa. Our there sales out those clinicians to clinicians,

ensure just taking of us in as that get but we So it's these leukemia to we're working time, get -- specialists possible. the some angles all with many as contact to

yes, terms claims. I had that paid mentioned In we've of reimbursement,

a had I we've been have been to OneCare have is kind exactly which that And customers a of of been able across payers team on are number label, of team, we our -- been -- But has there work Our out say that and been in different payer presenting get clinical And Rigel they patients very a things indications We've resulting would referred interactions off want. of with our positive. the in PBMs front. wins to doing market received going secure data. overall, access continued who field we've prior has cover to what reimbursement. in many, number a lot to our lot of many overall, that

issue for reimbursement getting an So, really at this customers very reimbursement REZLIDHIA little with from it's heard about I've but getting early, for time. still --

And remarkable results And KOLs. that's an among olutasidenib. the who just happen people seen is, going to you think have touched or you're really do really this -- there olutasidenib about exceptional believe here peers I educational going REZLIDHIA. have The clinicians has we're the in thing job. telling in of seeing brand forward. And done team other and believe we have out more programs And to, as do this move where that are their obviously,

peer education haven't We peer even established our yet. to

right we're that So on working now.

-- do So I'm fluke, do, is it's ability to know about drug. I this -- am this isn't isn't we've to very confident not What not but work raise a awareness. got our of a a we lot

it's about Speakers] getting [Multiple know and the don't think a leukemia. see the winner I word who out just people I it's to there

Gary Nachman

test diagnostic Speakers] A up [Multiple

Dave Santos

all, it issue in They may may clinicians have it mean, They order party. institution. I at Gary. think not third that's the through I it any number. an a that is can from get

may to that, than it's results. of what Right? the the I academic results think with so, able in And they be get more quicker. results the setting, clearly do they

we the why leaves the they treat. then inhibitor setting IDHX that, particularly may But opportunity. clinicians, choosing of in that, applicable relapsed/refractory more which they're in and frontline. the move forward is with to the in clinicians positive. it's to the don't a lot This just believe need issue. have of open do IDHX wait A that an regimen, we and community, That's is so lot And -- if an to

a reinforce So, rate that's we'll XXX% I now. is setting, high But just a there olutasidenib the going a it. talk drug of IDHXrelapsed/refractory standpoint, it's we'll saying think think about high. of a to relapsed I in refractory patients. on continue testing that continue in It's not choice And to out there's from I'm And right testing.

Gary Nachman

XXX. that was And All Okay, great. helpful. then just on color

overall consider what little for you X licensing opportunities bit that? you any be So when to data looking point then all asset? Cohort that moving going what on will from you're to X? the see Xb that be MDS cohorts? for in Phase patients? And you anything, what low Are available? you. the learned interim will in have at And a going wait for data Cohort data Maybe into risk Thank maybe we would And this

Raul Rodriguez

piece, the On other. start the handle I you with cohort. maybe last dose first the

of for at the stage compound, this this cycle all, of life safety. look of we First

as really told tolerated. So no you, I any interest. was drug well There were of ease

the X efficacy cohort, bit expect is PK profile cohort low big effect Cohort range a a pharmacodynamic wouldn't first a really closer. where really with to next going yet. that Now -- is little dose we a which we're the approaching

So be all open next remember, this continue study. And all is the treated, an be that and patients to patients. these will label they three of

might that at or and look the the XX cohort, in look oral those cohort be of like X, something hematologic a in cohort things dependence, also response be say, takes So it something a we activity Cohort I'd it's months, or you to rough in as It days there's we get it continue at then next and endpoints rates, improvement. And safe look remission, now you handle data can major once patients signal of X, but safety escalate X. like three whether some evolve, to there. say might at transfusion clinical

We more will those add patients. and expand

patients many do there, there's would I And for discuss you say, then, a order signal you I long in how a mean, yourself with Whether partner. think for can want to how what in And probably months good several we something we hands. then patients position say on for looks. data in be a three the our would to depending have six pretty to

Dave Santos

lower -- dose in from it's some more data we it group, will the I a think Clearly, have safety. So might be those.

more where is it really three Not And dosing. signs at. having get the into dose six only we'll what there that's that's after three safe, likely this or we for some but months benefit As efficacy is also groups, see signs four partners to some are of that this probably looking area. is a in

a well It's kind it risk we to is thing. for that and such data of adapted It's exciting partners a is these and an we at low to the enrollment higher MDS. study. going in have what enrollment. unique. decide mechanism condition to data to mechanism is it's then -- an see three plus of question. know a potential do same exactly the expansion It's groups to same of -- inflammatory we'll Gary, the want design so of -- dose opportunity dose one -- certainly to But good when a this sign It's see need to expand to say not as the And the because driven your because look that hard answer that going which So the product. don't The we're we treating overall. is higher the this at that's to well, partners certain, want

So about we're of excited the this. prospect

Gary Nachman

Thank Okay, great. you.

Raul Rodriguez

you. Thank

Operator

question Pantginis question. proceed H.C. line next of Please Joe the from comes with Our with Wainwright. your

Joe Pantginis

Good afternoon. taking question. the for everybody. Hi, Thanks

little macro. my So a more question, first

and is particular overall cost can at for of time? I that So for I'd your if if business $XXX force like this we side to the balance essentially in right Dean's the management million moment and around sales correctly. commercial heard guidance you XXXX infer cost the And sized of

Raul Rodriguez

$XXX that. any million. if there's on can think the I the on answer Yeah. Dave Well, comments the other rightsizing guidance And of

Dave Santos

Yes.

the teams to think have marketing drive from we across people I Both both operations resources sales. we need we commercial to market the access and and need -- are to we brands.

Dean Schorno

Yeah. leverage seeing And but $XXX the we've ability XXXX? about the as seeing And described. time organization, field the I think, and that and expected launch for efficiency that in I we OpEx sales whole that Raul think million team, commercial to just for that the the Joe, leverage But whole not then just -- some the in in team. all our efforts REZLIDHIA talked now you're in did we're

Raul Rodriguez

is last of in We number We The areas. let restructuring had colleagues a Yes. our for go $XXX us. earlier good year. some million a of earlier

to do some of managing focused need in in that We what rigor terms us also we to too cost manner. took a real more so do it our allows

it top think was the year. that. of a And look I expense I trending good to downward a from think from flat And relative line, do to forward products to practice growth kind in last both line continued and also partnerships. to then

too distant future get to not point. that to the in So breakeven

Joe Pantginis

especially it the Okay. That's the the put guess, the for little if we've you first, describing with here, refill number definitely sorry is. a been an hear guys into see and it's way missed the it. post-COVID have -- out been early at on helpful. at this, proxy regard And describing or then though, I it slides didn't it, pavement it you with way least new the as looking that have to been you TAVALISSE a guys pounding don't hopefully diving current further what franchise. I the number. And down the I'm rate I

the the about earlier as now go you different you're look territories refill and and as blocking other can into are lines, as geographies. with you to talk into first, and that what rate push seeing right they any of as So tackling competitive well sort expand Grifols headwinds the potentially

Raul Rodriguez

rate comment can post-COVID conditions? and the on Dave, you refill

Dave Santos

our we Joe, change we Yeah. persistency. I in have any -- mean, not seen

like offices focused bring the a that sure they on them of know clinicians on that we change to make all things the you make doing product. haven't really brand. new seen continue persistency. a up have sure in We're prescribing And you are get We their does the bringing to who to that, ensure dose with XXX patients efficacy, to team in keep the but work to

brand. on more Our patients growth -- new is are because being more the

like keep And to it it so, we and we would side seen of is, haven't where just any it changing.

I hope that helps. So

Raul Rodriguez

Dave, COVID COVID on. a Post situation, our so And terms and yes, continues. from team access post in of

this think of institutions. I is part those

more institutions be difficult get But seeing still Sometimes to and yeah, it conferences. appointments, into to interact think than live those more the can office buildings. with more clinicians more especially we're opportunities I

I think of for customers. our been all interact great able teams to with to that's field be a opportunity

I think all helps. it

Joe Pantginis

Thank you, guys.

Raul Rodriguez

Thank you, Joe.

Operator

question the Patel Please line with Kalpit next from Our proceed Riley. your B. of with comes question.

Unidentified Participant

is for Fleasure] Good [Andy (ph) taking Thank Kalpit. on This for you questions. afternoon.

development then you still compared that other such trial agents [Sanofi's] asset, that sponsored in Thank as you're know the I published a this this GvHD house considering maybe do competitiveness partnership? just through Regarding on, [indiscernible] in how something these (ph) developing [indiscernible]. in is And perceive would think investigator follow-up, as or you a consider you of emerging of to results data you potentially you.

Raul Rodriguez

think [indiscernible] well? I as

Wolfgang Dummer

Yeah.

to I a think question really. I similar responded

like over data. paper the some the size with ballpark. certainly do Sindex enthusiasm sample it's preliminary reservoir, of compare response in has If you you around numbers feel and also data we It in the limited investigative numbers, sense if you for we overall they're is example, interpret rates don't competitive the in we so approved looks said some compounds, there. substantial want out but the The to fostamatinib

this it's certainly looks at population. early would certainly -- also this still So in say, I point, but it's it's competitive patient

Raul Rodriguez

you as -- Dave, you what well? can comment

Dave Santos

Yeah.

and has over that's -- are And done one I But is, study category some don't NCCN approved end. wanted not one have obviously, GvHD. is the you Even the to they say since, while They though research a trial. what agents even at we look the evidence. and the think published. tested it's really, they about other. the came encourages the what products this, one out NCCN I of thing clinical was preferred have we've if clinicians And large guidelines,

a this, look we at no area that if a an is a pursue that or there we clear as this so space And this we kind leader in do development if of angle is GvHD.

you in approved to will guidelines the both of again, approved. NCCN could, And And GvHD, that you encourage for hematopoietic in listed I see look a are you and so number not transplant. at agents

Raul Rodriguez

Yeah. are opportunity. And to as an keep at in we looking mind, this

proceed point of I said new to with We we trials haven't like to made a money a amount it registrational or decision spend do for agents. these -- at earlier, have on two limited this and

we so And to return bets specifically. where have and look our a of place term and those think opportunities we return us all greatest gives near at

Unidentified Participant

Thanks. I color. appreciate the additional

Raul Rodriguez

Thank you, Andy.

Operator

remarks. queue. further Rodriguez back hand to No in the the Mr. I'd like questions to for call closing

Raul Rodriguez

your where of a year Thank and where Rigel. was year the interest I Thank we tremendous terms in that in both year. was the you, It started a ended for and best think year XXXX, challenging, you year but operator. your questions we at our

really then company the commitment externally. to of we're these with well transformed continue And transform And positioning year the getting that. that again REZLIDHIA to this and we in think within look that are us we I complementary substantial product, look grow for on our company think opportunities two and XXXX for continue growth assets, that's of I TAVALISSE, really to exciting to this that these both other in will products, you addition really highly traction. executing will

terms are of interest number that there In a well we things have there opportunities, of in. quite as

for think great us. be year So a will XXXX I

So deliver. thank aim to you your We commitment for to us.

Operator

teleconference. today's does your this you gentlemen, and Ladies for conclude Thank participation.

disconnect wonderful at and time this day. a lines your You have may

Rigel Pharmaceuticals (RIGL) 7 Mar 232022 Q4 Earnings call transcript