Rigel Pharmaceuticals (RIGL) 5 Mar 242023 Q4 Earnings call transcript

Greetings, and welcome to Rigel Pharmaceuticals Financial Conference Call for the Fourth Quarter and Full Year 2023.

[Operator Instructions]

As a reminder, this conference is being recorded. It is now my pleasure to introduce you to our first speaker, Ray Furey, Executive Vice President, General Counsel and Corporate Secretary. Thank you, Mr. Furey.

begin. may You

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

financial forward-looking outlook the are Form a call and for forward-looking undertake These forward-looking of our to Raul? Any differ on our As ended description over risks today's these A during XXXX, Officer, this turn events date, recent statements for President Chief may timing to Raul we report time, today's statements that of to those would those XX, actual cause on to development. Executive to year most annual the obligation our make may and risks XX-K regulatory like we reminder, Rodrigez. the and call, subject I and product file can SEC. and uncertainties with to or forecasted. circumstances. found December statements on made from results plans regarding and are no reflect At as our subsequent only statements update be

Senior Chief today Thank Dean Executive you, our and Ray, of Joe Dave President Financial Santos, are today. me President, Chief and Officer. for our Officer; Corda, Vice with everyone, Development; Lasaga, thank Duane, Vice you, Medical Also Corporate Commercial Francois our joining our Affairs;

our on [ and we recent today provide Graben, addition an information most exciting substantial have presentation We ] our portfolio. to will

followed minutes run to XX by presentation approximately this would to this, of Q&A. Because XX be

on begin X. me Let Slide

to the in and forward are significant hematology XXXX. this oncology remainder of in the and we momentum business year. our the We the in early XXXX look of maintaining throughout progress thrilled made part growing with We

ResliDia-in XXXX. our growth and this both refractory the ] teams. by sales our therapies outstanding of XX% for an X growth saw record is marketed the XXXX Tavalisse mutant entire and in be over -- AML or organization. This IDHX initiatives of and medical and can execution a commercial affairs Our to attributed ITP frankly, [ products, across performance relapse million. $XXX

We focused or for expanded drive this we treatments. fusion-positive X lung our recently, with cancer. the continuing RET of are cell commercial the for portfolio metastatic product on Gavreto. droid growth of growth to metastatic Most acquisition FDA-approved non-small advanced and these therapy treatment cancer An important

compelling treatment corporate representing non-small providing fusion and to patients a portfolio, RET growth. positive the execution existing strategy, valuable cancer infrastructure and addition our leveraging of This medical is our a affairs of commercial targeted is line our Gavreto the acquisition cell option disease. top part with for lung

Dave We about and later more will Francois speak this have product call. on today's

our X of we including a addition our efforts, programs greatly enhance Connect ability call. and ReoliVia's We'll this in cost-efficient on These AML, potential our are advance important of in continuing In more a and later to IDHX development MDS manner. commercial broad plans further Advancing with alliances. recent to alliances touch synglioma. these and goal to Reslidia Anderson MD range cancers, evaluate strategic mutant evaluating our time-efficient with

In lower-risk of advancing RXXX, Ib is MDS. addition, IRAKX/X study our Phase a in inhibitor

breakeven. expect we the well clinical sales as in disciplined our development, recognizing and the reach growth to which revenue third growing of as the to With of Resolidia we cost-efficient approach quarter are to well of XXXX start to and addition continue our positioned and Garet, TAVALISSE business and financial

and the portfolio. you product excited why to acquisition grand up give of so me our let this we're Now to rental an overview add

place to between patients have XXXX. importantly, and this XXXX. oral we a the synergies U.S. the between U.S. the with that expected product the in the systems to compelling to their let in say a bring million right treatment acquired are issued to expiration we need. us our and What this established delighted patents available are $XX and this U.S. We so and once-daily First, with this with that sales and right physicians. to to to makes product issue people more to statutory or is market XXXX believe generated in having and foothold an acquisition making inhibitor and have Gavreto product continue are date me net existing RET redo in in Further, expertise. infrastructure patients rights portfolio,

royalties it With position payable more that, a economics as BLUEPRINT In million, upon as are positioned again for to product Dave? the deal date. closing our The first anniversary Francois then the Rigel well million very to over about begin and these put believe milestone sale turn be to and tiered in available for on talk $XX and We potential recognizing to us in the will the Gavreto U.S. Blueprint, to to will value million. which sales sales $XX payable regulatory opportunity be and pay XXXX near Gavreto. rights partner, future which upon quarter commercial commercial are from We in and the good we of third presents. purchase make $X of of I'll the exchange to of price net and this well come. capturing payments a be Arena Dave first the program years Gabe, of call great includes for also will to term.

FDA-approved On a require adult the adult non-small therapy vent as as of and metastatic or with Raul. cell who who lung cancer for patients hyodime treatment pediatric older age years X, thyroid well patients the refractory. by X in include RET RET with reviewing Gavreto, begin which systemic fusion-positive Thank cancer and are of indications you, fusion-positive Slide I'll radioactive

Raul's the FDA-approved addition targeted oral remarks on to our I in portfolio. Moving therapy and expand why Rigel is strategic Gavreto want believe opening to third Slide as commercial we X. a In

the more $XX reported GAVRETO than grew generated nearly year. On million of above in Those almost Raul as left, sales XXXX. U.S. million in XX% net last mentioned, $XX sales sales

clearly to We RET So this and reasons. few an patients non-small this cancer. our fusion-positive lung important therapy advanced with thyroid for opportunity meaningful Gavreto cancer opportunity to a continue compelling cell believe well is providing business fits

been an First lot for testing recognized associated move immediately patients testing where and therapy. and therapy are maximize have specific foremost, actionable efficiently already most awareness to RET FDA-approved of to and the tumor clinicians targets importance solid those and invested effort it a of biomarker of immediately with and a market, enables us into already a Indeed, the targets. to both large as time

non-small market anticipate the cell we as So RET patients lung that continue cancer thyroid identified. lower advanced and RET to fusion-positive are expand will

Gavreto. Secondly, patients we and to we have current access ensure newly have believe strong leverage immediately access built prescribed to that capabilities we can

responsive Gavreto. importantly, that We coverage ensuring highly have with an distribution to strong ] and [ of [ a we therapies, patient TAVALISSE ready services hub for have Rest Rigel-neCare will established difficult-to-treat track efficient targeted accommodate has that and Gavreto, that reimbursement network Lidia a combined continue ] be our plan record diseases we with being to for with and soon to providers. in reputation oral And patients

opportunity, call academic teams complementary Lastly, both to and this both we medical footprint On will is sense place us already accounts. resources discuss community field as X, Slide who we multiple these a in the market makes perfect cell affairs With be non-small commercial practices. have accounts, with provide we these on our be oncology cancer. opportunity for able products more overview it brief highly within our centers and our even lung efficient in biggest to Rigel time because of and I'll

cancer will X% cancer test RET of that those, be X% lung those total lung be patients. diagnosed fusion X,XXX on approximately positive to XXX,XXX XXX,XXX cell patients the lung to You the non-small this or non-small XX% And patients us positive patients approximately cancer approximately for will non-small Approximately incidence cancer year. cell a this RET XXX,XXX will cell lung giving of fusion see left of XX% will year.

slide, are of for last on RET shows side in right research graph the first-line the the were eligible On used fusion treatment. the who patients therapies that year done positive

see, about approved RET X of with in the inhibitors GAVRETO about FDA RET used with were treated X the X/X can of of you As patients inhibitor. patients X/X prescribed a

it's Reto growth still inhibitor cancer there will opportunity X/X over share from We rolled let as of lung the inhibitors to quarter this you patients. lung being by is and treated fusion-positive see suboptimal patients hear chemotherapy treatment patients. a or the with more approximately can cell Francois a the checkpoint that are RET non-small have will about RET you impact fusion-positive because in biomarker, turn and therapies of as for on of those of inhibitor. immune Importantly, market, cancer without lung RET an view multi-kinase me Gavreto cell cell non-small the to RET profound Francois it cancer With in Francois? that background, non-small or

Thank you, Dave.

of non-small activating you specific with on metric. Fusion in cell identified overview role fusions, red Regine X% patients of variety which and Slide historically. and In States. is with Two cancers gene. new papillary tumor why growth lung data owing fusions been brief aberrant with On give actin. RET thyroid -- another to the fused cancer focus unrelated the have and relevant cell tumors right year me cell XX, to a in Let have solid a and non-small and primary ] non-small lead to X% cancer of of altered summarize approximately approximately a proliferation the processes, patients mechanisms DNA cancer, are tumors. can across RET non-oncogenic tumors different United for identified, have underserved X,XXX representing been a a solid many driver will cancer, red in and in the I to is [ repair clinical fusion been

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in inhibitors, or clinical Moving multikinase setting. some to Slide degree anti-RET in RET they had XX. cell shown of lung activity cancer non-small lenvatinib fusion trials evaluated including vandetanib, as cabozantinib, positive Early the preclinical sorafenib

from treatment-related of toxicity and rates However, short resulting these progression median response high their clinical with survival kinase to X% XX%, ranging from showed inhibition. activity modest rates agents non-brand free

driver oncogenic progression-free survival X.X in same an of PD-LX treatment expression data ALK chemotherapy, to in the brand metastic as all response may further and and X is toxicity for practice platinum-based such the fusion been around ] elevated rate in RET, state patients benefits. treatment XX% X% oncogenes, PD-X for range that with with inhibitors advanced contraindication some should with activity highlighting presence treatment rebend less with Owing with Although low non-small response driver cancer, predict paradigm be targeted showing patients selective survival immunotherapy lung and an cell more rate XX% centered exhibit therapies. of [ may effective that Furthermore, EGFR, such need practice for PD-X, for RET guidelines therapy checkpoint RET, the as effective a take months. disease can or months, and lack immunotherapy PD-LX X cancer which with positive preliminary the and patients both cell of of provision have suggests lung advanced multi-kinase guidelines immune recommend inhibitors to with to include of which in historically and over the the that concerns and Therefore, inhibitor. small precedence oncogenic

non-small several the Red towers more target oncogenic fold past more kinase. over for studies Preclinical mutation and XX been also activity While the of with including in in is gold to ] selectivity X for VGFRX and past decades other multikinase Pralsetinib rate and red and has than tumors. potently shifted in against non-small biochemical FDA cell the and chemotherapy tyrosine use has to to is approved shown pricetinib driver for targeting high an therapies associated XX long inhibitor JAKX of has the resistance intracranial blood-brain and and cancer has kinase mutation, for and shown red selective specific Pralsetinib cancer. cell fusions biomarkers, barrier in standard XX penetration selective [ over the inhibitors metastic mutation therapies years. landscape has that The selectively assays than

first-line therapies metastic also guidelines eligible and treatment for with non-small cancer practice genetic recommend cell patients variants. actionable targeted with as Finally,

for that from approval had portion Let's turn endpoint ] Phase ARROW open-label in advanced multi-center, a attention baricitinib of Phase study is and red disease XX [ here of slightly clinical non-small overall the the cancer. study cut the on data had lung co-primary Key of benefit be led free toleration of Slide [ to now ] prescribing rates, endpoints ] while RET expansion thyroid slide control more The on II secondary The survive. [ the setting. presented recent note dose fusion study fusion the that a or and price I/II clinical represent I the than Phase endpoints overall must maximum results tort cell this safety. The were data study. of our both II dose and for dose results duration positive information the different rate one survival primary and therefore, I to may the Phase and a rate, safety. cancer escalation in response and recommended consistent portion response, metastic of study highlighted

previous in from subset XX.X acitinib of XXX intensity of and XX% months of and baseline baseline was duration population with non-small to ARO cancer at cell as baricitinib concluded patients, the investigators and grade dose antitumor events, adverse to generally the I, Phase QD. was XXX-milligram Therefore, safety, PK well on QD the platinum-based In in and of responses Phase was at the the the II naive and shrinkage to recommended discontinued XX.X XX.X the duration In months. patients Overall, tolerated cell and pralsetinib relative determined activity. XXX From treatment-naive durable patients, generally of in endpoints to XX% for that trial due tolerated dose dose median in key with XXX-milligram torted one post adverse ranging the based maximum is doses chemotherapy of was to XX the XXX well of mesorable prior of platinum-based were events. non-small disease. patients observed treatment overall of subset, XX% response, the was median patients. Tumor XX% the in secondary treatment-related and a XX.X% treatment safety median recorded predominantly XX% with with X XXX% and cancer months chemotherapy of

patients subset, In cancer the thyroid continues baracitinib manageable fusion-positive cancer previously RET positive XX and treated out show response. fusion a to achieve profile. efficacy thyroid safety with of the a RET XX

developing non-small colorectal XX Finally, fusion is tumor subset On response ordered cancer solid overall example, from and you in of the control cell cell development including or and XX%. positive was half XX, that and evaluable a intreprenel trade positive see is for inhibitors shown brain can and therapies non-small the rate survive, prognosis disease and XX%, diagnosis. fusion non-small metastasis had of drill, with cell at and metastasis patients months. study patients during medium rates of respectively, cancer at such time multi-kinase response XX% a Non-selective cancer. patients X.X in with factor progression-free brand have months In as X.X survival and red short CNS rate and the the metastasis patient of was with Slide nearly common for and efficacy pancreatic lifetime overall cancer patients, patients the RET by their low

permitted associated study, if neurological metastases CNS Patients ARROW with were untreated progressive in symptoms. with not the

including preclinical penetration in with against brain have overall you present entrepreneur tumors. barrier response of in rate, response intracranial In by the metastasis inducement the patients fusion-positive of to of showed cohort and with baseline pralsetinib shown measurable activity XX.X out I X As complete response of the in a of pralsetinib cell of have non-small XX% patients duration XX or studies and cancer median XX% months. and indicated activity earlier, study, cranial blood a

established and XX% previously inhibit blood-brain therapy discontinuation cross in adverse does not for durable history and manageable rates prolongation lung population activity. with with retaliation to response profile regardless the demonstrated comorbidities an events warning to a the XX% for of cardiovascular rate. selectively Pralsetinib intracranial non-small treatment Moving safety the QT oral approximately barrier Pralsetenib once-daily incidence only cell Pralsetinib low to and in patient proven of is treated Slide clinically has It XX% is importantly and cancer a demonstrated and high of XX%. range for has has the carry cell cancer and precaution patients. treatment-naive response where non-small to XX. rates of XX% is

us positive RET for recommendation recommended patients category cancer is RET-positive With a In pralsetinib turn RET elements firmly as plans talk back over lead and advanced XA nonsmall practice believe non-small and pralsetenib cell and about for Finally, that, conclusion, to differentiated those certain therapy pralsetenib. guidelines will for cell a has and all as the are metastic a option treatment that first-line commercial to metastic with cancer. Dave proposition. cancer carry positive to by value preferred the call I

Francois. you, Thank

Now with we've our and the also line TAVALISSE overview brief briefly as XXXX. of I commercialization clinical move nonsmall RET, our a lung showing oral plans cancer the BrezLidia. opportunity exciting I'll and cell QX X targeted Gavreto an and review and wanted through covered results we that time the to other of provide both overview momentum therapies, continued Gavreto,

great want with more capabilities are provide this why I opportunity XX. on detail little our believe Slide a suited especially to Moving Gavreto. to to we

our swiftly efficient dependably patients Res an that overnight. delivers to and we and First, distribution and accounts have TAVALISSE Lidia network products for

can network accounts Gavreto and accommodate readily Our patients.

of existing strong which years to and leverage GERD fully team commercial ready customers. those we experience hub Second, there will levels continue our patient with provide providers has and high has payers. coverage services lastly, ensure And have that with to the led of and our our have to working to patients and payers be outstanding TAVALISSE. relationships team access And to X OneCare we patients, also over XX% Rigel networks coverage same with our will reimbursement services achieved

to already XX, have begun have newly with we continue interruption. to on the Specifically, a working patients. both prescribed Slide from without work RigelCare and OneCare ensure of and assist process seamless programs. access BLUEPRINT moving patients to current Rigel existing to transition closely will and Genentech network to for programs, network access providers and Rigel the patients Genentech ensuring in with the Gavreto patient

of ensures and choice their will built where anticipate is network OneCare distribution highest in provider dedicated support for the staff transfer in as fully patient believe continued Rigel ensure QX begin drivers patients Gavreto access the Our prescription journey the beginning we with service. commercialization we transition reviews Gavreto. in level the We and X XX completing our QX. key customer what Slide have we all and to and are growth to

that those lung important is possible cell It identification. X,XXX identified non-small as many patients patient as potential fusion-positive is first are RET The year. of each

if even patients to the and more having test same And due with clinicians RET of being recognize XX% it's they of clinicians the when about tissue not that in test, as in biomarker the therapy. associated aren't looking tested. patients Also academic both an Fortunately, them XX% community last settings. year, FDA-approved about do cancer for fusion-positive specifically cell likely When research RET being non-small adequate are immediately available. conducted the lung is don't

Awareness and that educate do of to we is will fusion-positive to patients. need RET drive or high, non-small anticipate So continue not [indiscernible] again, patient of the identification about testing. clinicians RET cell a importance

are that to opportunity line. familiarity yet identified of importantly, in Gavreto, biggest is front for GAVRETO Most Secondly, an growth eligible have the with us. for in who drugs. try impactable choice and and those other treatment for And comfort more the reason patients is therapy oncologists

among oral and immune opening patients. of an daily efficacy, RET my from use the of with and inhibitors of we growing Gavreto Francois' current of checkpoint or chemotherapy of once inhibitor, dosing, the Gavreto's By in heard grow you fusion-positive multikinase from about and safety presentation, awareness first-line can X/X we As nonusers. the future comments use treatment believe use without represents

Gavreto due to persistency its convenient finally, dosing. and we Gavreto our patient we prescriptions. the will obtaining services drivers we can view once-daily patients continue of users and their business duration leverage from coverage, for refill that inhibitors. Third, to reimbursement drive discussed as as month costs barriers and difficulty long who believe as to continue each we of believe in response clinicians with gain our out-of-pocket as We use have Rigel And should These of strengths reimbursement grow OneCare. carryover RET loyal of

In of Through said the drivers. a network the of high-level of the the through year. newly remarks in transition implementing positioned are growing we wrap momentum on up I to we'll our well rest to prepared will and wanted And quarter, begin X line to next plans positive these for distribution to preparing summary, key time plan the prescribed Gavreto this provide be Gavreto RigelOneCare current continue month, Gavreto beginning our addition patients. for Gavreto,

to to our be academic I Gavreto updating Then begin progress portfolio QX, expect will promoting and forward on will field Gavreto users. begin oral both you into targeted focus breadth with and look our as nonusers prescribers year, It customers by moves our also teams. ahead. QX, will the of expanding to settings. we on continue it in in current an We exciting and our calling preparing community bringing therapies, on of the year In we a distributing

Moving to XX. Slide

on in Just see a us full enabled first growth approximately generate full the brief of $XX impressive $XX grew you Slide nearly first in of $XX U.S. our growth reached for over our of starts, consistent million quarter comments year, sales growth to RezLidhia XXXX, QX. continued representing which quarter. million net average million was a year On million That net fourth than net the from will new focus total the in few highest XX% an in prior that quarter-over-quarter sales, TAVALISSE, our generating portfolio rate. with million the in was driven year the and on as product more to $XXX the by the $XX TAVALISSE year. sales product the quarterly strong growth growth driver this generated daily XX% main patient launch. progress That continued of of year up our XX, of XXXX growth

momentum also our starts and beyond. will XXXX this top to way, Rezlidhia net in believe fuel million of contributed We product line a patient continue growth in with to new generating $XX.X in sales. TAVALISSE meaningful

both increase And building our growing call attention, for of brief forward a on next back your to momentum Raul? you among XXXX, Raul $XXX I and now I with are And awareness we like the provide Overall, update that, this thank and million to treaters. to adoption development updating look great XXXX you of of We breadth depth our product to we setting. XXXX, and and I'd we over beyond. quarter. on again will opportunity adoption surpassed progress. on to look AML are see progress turn academic in for a and Rezlidhia U.S. that in sales net the forward community in thrilled to we

Thank you, beginning expansion XX. pipeline Dave. provide updates our summarize I on other and plans development on programs, Slide our will now

and -- X of here's major and we're going our hematology oncology Beyond grow indications, the growth approved X products our to ways. how business their

underwrite. First,

possible criteria. companies We meet continue that in-license or with possibly to -- acquire will our or products acquire

infrastructure. with or oncology that our in and into are products late What soon data differentiated hematology more products to or looking this advanced We that have areas, fit registrational stage. are registrational for or oncology data means is related or with hematology

[ company transaction an this products. decision made Rigel presents versus recently a attractive to partner Two X novo. product companies in with is building such a more with de infrastructure a entire already our commercial acquired have alternative a ]

other the opportunity. space, encourage approach. oncology such ability for and reach products this if us have have do hematology We to we to to they are pursuing the We an and actively in this companies out

[ strategic On potential is we with portfolio, product to slide IDHX plays new particularly current new has of we're glioma in Anderson segments and indications. our next we has ] promising going MD into believe [indiscernible] slides. how in in a current grow We left numerous entered see these with additional and mutant support touch in to side the role. MDS with AML, cancers on products earlier the this these data in From volucitinib and Connect mentioned an As indications where this indications. more alliances I'll our agreements call, and further evaluate development

We inhibitor demonstrates IRAKX/X that RXXX, of trial. to provide potential a treatment And other Ib patients program Phase is ARC-XXX continuing with who hope much this lastly, enroll its needed failed the our to agents have option.

the to Slide review have expect that, Anderson. with data With first this turn XX strategic me We to part late this of trial the year. let to preliminary efforts from MD

very providing a of quickly. and clinical post-transplant with and future, As potential the the the and the million lower-risk maintenance they of to conducted many run in being the That's and over up manner is population $XX a They today of -- us the of care but and studies center care well world. Anderson large with including U.S. cost-efficient in you X They pride patient X planning of in [ are a rather center MD are X X a combination first-line infrastructure We AML of in of high-risk trial and years. populations are as There other of with patients. particularly not premier going have excited conviction a know, Anderson paid treatment standard themselves capabilities strong evaluate that cancer MD the aldosutinib. to trials MDS standard [indiscernible] in about in cancers, olicidib MDS frankly, agents. in share ] in we We're therapy potential also in defining patients as various AML to to conduct CCUS in

to is data This is also in opportunities. they these quickly as various time generate a pitched are able very

us have We for to a trials up registrational a subsequently, to MD proud expect these and Anderson we're partner. conducting very set as trial

patients Slide Glioma XX% XX. to year. X has are that cancer cases approximately unmet of patients every for X the very grade of high Approximately of are is a grade on that is mutation positive. prevalent limited treatment effective U.S. in in and IDHX X a options and Moving tough fairly patients options. glioma treatment need there efficacious. XX,XXX and a There is This X% X% Grade these to are

On control no patients demonstrated of this and refractory Olutasidenib side outcome XX dose-limiting a the for in a evaluating right slide, very highly relapsed population. with this from In Olutasidenib prognosis good show trial, a we patient disease meaningful a very were toxicities data observed poor treatment-experienced or glioma. rate, trial

XX. Moving to Slide on

consortium is to excited for our IDHX evaluate patients to and diagnosed consortium -- glioma. trial adding pediatric adult efficacy II positive high-grade is newly its we umbrella to and evaluate We currently mutant a that trial collaboration with Connect conducting a patients in young with are safety Connect are in Olutasidenib Olutasidenib glioma. Phase this and glioma. with

providing of Again, approach. material and up will the in to We collaboration. very be time-efficient study a $X X-year million period over for funding a cost-efficient

Dean? Dean these programs. forward excited we've programs. with very our we with potential are very across a prognosis. treatment made patients about are over development and to turn Olutasidenib's these call that to much such excited reiterate provide continuing me we I'll a for We financial that, option that, needed let With for look poor update. progress advance a to the With to the

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

for As of to typical I $XXX,XXX highlight first of the for I'd like net that the financial highlights XXXX. income review fourth quarter reported begin to our quarter, we

sales, through royalty structure. in TAVALISSE the with to including within this net leverage our my in the academic revenues, and partners our management that periodic been operating purchases Rezlidhia and in from and international both and disciplined have cost continued drug settings this distribution supply product financial we're business. accomplished We're across expense successfully community increasing sales load able grow of seeing was review pleased You launch that part

I'll highlights. now detailed provide our

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

of and clinics, shipped while in distribution of were distributors, quarter shipped channels in specialty bottles our bottles reported the fourth sales. patients of of $X $X.X a remaining We levels increase period end the same Rezlidhia compared Rezlidhia to sales fourth of product million the from the XXX in to million product in For XXXX, XX% at sales XX in the of net quarter. We quarter XXXX. million quarter fourth product increased our we the from Rezlidhia of XXXX. resulting the [indiscernible] TAVALISSE net gross $XX.X of of to reported XXXX,

sales product TAVALISSE other rebates, returns, and chargebacks, recorded million. and net $XX.X discounts, of estimated from co-pay assistance net of Rezlidhia were allowances Our

XX.X% our net of adjustment product and for respectively. For of the gross XX.X% was and TAVALISSE Rezlidhia to sales, fourth gross approximately quarter XXXX, was

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

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

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

to of continued bottles remaining quarters saw in highlight XXXX XXXX. third see For expect bottles to quarter in XXX I and distribution fourth would that increases first end strength bottleship at we of channels in our for and respectively. clinics TAVALISSE, patients XXX of the our and the we the in of Rezlidhia,

see of Rezlidhia our increases, of are these first TAVALISSE we XXXX. Given levels outside drawdown and Both and the the inventory quarter inventory control. expect to of these variable levels a in

for for to approximately of we in net XX% Rezlidhia. the Incrementally, XXXX TAVALISSE first approximately XX% expect gross our quarter be adjustment and to

Finally, Gavreto third On slide. progresses. third the of the year as recognizing start this updates further the -- do until [indiscernible] expect from the look to to providing not year. as next We quarter quarter an forward to important reminder, we of revenue

from to quarter of product of periodic $XXX,XXX. our addition revenues sales In approximately fourth in distribution XXXX, $X.X Contract our and $X.X million were million from from contract international approximately revenues collaboration drug approximately the partners. from were of revenue net our revenues government supply purchases contract approximately royalty million at $X.X consisted collaborations

Moving to on and costs expenses.

product cost compared XXXX. approximately in were fourth quarter million same $XX.X XXXX. in million period and the Our the $XX.X $X.X fourth sales Total cost for of of of quarter million was with expenses the in XXXX

III cost hemolycinemia Phase [indiscernible] with IRAKX/X due activities the our due decreased timing was inhibitor development related program. to immune clinical costs and The decrease and partly research related the to of to completion expenses [ the trial as in trial well activities in timing of COVID-XX ] to patients and as of trials fostamatinib

fourth the addition, in-process of at In decrease expenses and cost was a quarter recorded to also lower within included and costs facility-related Therapeutics due XXXX. to in milestone payment R&D the forma

of our increases business typical full increase along total into with cost progressing XXXX of previously forward we by and increases we as and currently Connect As we our goods very and continues for we with to Incrementally, XXXX, cost business compensation manner Anderson in the a in expand. costs MD our expect year to sold expenses our in annual reported. cost-effective move other strategic that look collaborations to

to with and costs, asset expect study Incremental the expect while view our be of of transition specifically less to -- SG&A look consisting this this expected we opportunities $XX costs Gavreto certain provide Rigel currently plan to to to updates complete these an related clinical interaction forward this we cost We further continue in costs, our -- the and specifically future. associated drug for XXXX. for with incur costs costs, development product, the asset million certain along to to than we new

back like financial call and short-term XXXX million. Finally, Raul? that, future. disciplined to quarter to we turn focus with into maintain Raul. the $XX.X fourth ended look the With cash over our of equivalents I'd investments of to cash, We and approach the

oncology Thank part XXXX hematology in and and of you, progress made XXXX Dean. expanding We're in early the very our of we business. proud the in

our to we of forward operations. and we expanding enroll we're We prescriber and MDS. products, additional to adoption toward of remainder are our low-risk broadening As the look partners, grow Gavreto ahead clinical look will on our in transitioning on evaluate Connect. we TAVALISSE in and Phase XXXX, Further, to sales we alongside to will of initiation base. focused awareness our are Rezlidhia Olutasidenib commercial And of continuing continue for opportunities our from development MDNs studies XXX Ib and other of our generate focused the data preliminary humanly

approach and to with license pursuing actively Gavreto our looking are we've We used acquisitions and Rezlidhia. similar additional do to deals

financial discipline, cost-efficient With your working commercial questions. the towards we the With Rigel to to focused products, will approach self-sustaining interest we the call to growth our breakeven progress your you Operator? quarter clinical in for in of financial company. that, fourth and now remain and and our a development making open on I'd thank like

[Operator Instructions] you. Thank

from Nochomovitz of Citigroup. the Yigal with Our first comes question line

There I ARO are have that approvals, GAVRETO. some approvals accelerated cancer. Tapestry then the specifically in post-marketing trial. requirements, I trial the lung a some RET question understand positive for done and there was these data And thyroid of the currently the was believe recision were there FDA were cancer, Lung additional work fusion some Rex with that [ -- expecting. I for some ] there the being trial. was additional

are provide just of them updates the any you are you to no what status Can and longer. or need whether anymore as they those studies continuing whether or

end. Francois pile ask and I'll let on at the I'll to answer Yigal. you, Thank

Yes.

tapestry. update So on and the give bit I can of a the study little an Accelerate

acitinib is the platform cancer. open-label that tumor metastic study Accelerate So as treatment cancer. care didn't of nonrandomized Tapestry trial of versus that with Phase of nonparcel amino is positive controlled solid actually enteric fusion enroll first-line III open-label in standard the patients you roll II randomized And for Phase does agnostic know, in

looking infrastructure, first beginning discontinue actually, actually global development for activities studies, the data down available. analyzing company I and and and mean, of Blueprint in actually given decided the Tapestry said, of well So XXXX. the That both Rigel quarter the wind Accelerate global learned Medicines to and lack sit has

requirements approval. Might full the And add non-small cell are a a interaction in we lung drug-drug in have cancer study. thing U.S., the only

are we or not we study U.S. full since that. conditional, in that of those have minor we'll was In in of the necessary some for noted. be have work, discussions. And U.S. approval approval maintenance it thyroid that sharing terms we to cancer, was FDA to discussions going So And that maintaining conclusion of with for you be a some as indication when necessary ACCELERATE approval. what's

existing the sales And then to a into the given with both you beyond expand could the well do current as medical the on affairs synergies infrastructure on see you're you world for tumor the where bit Gavreto. the hematology that the infrastructure, just with the synergies world, expanding solid reps little respect as

you. Thank Dave?

Yigal. Sure. question, Absolutely. I'd love to answer that

solid and at XX%, the of that there's from years just standpoint solid level if an First we of XX% tumors. them experience our of on -- and all, nearly team, tumor looked is field have team, our in experience XX experience

then on cancer those team lung if you have X.X an of And we our of field than in lung, half extraordinary our at average more about medical with years. So team. the field affairs has look team, which experience of half includes experience

[ the strongly So oncology we very because a setting, are accounts. quite calling its want to there And bit. same everybody I sure ] understands exploit doc-treat on make lung in the that they're community it. experience to want

treaters. very to then, large day. a a now in agent, tumor course, talk we're efficient we about the can very, product about the AML albeit in will very But centers, TAVALISSE those and product have a those [ centers. treaters already that's And but we lung-specific their need relevant we obviously In with a we'll and practice of go is centers. so discussion in X what to targeted each And call have Restlet academic type to on a with so opportunity ] makes those academic have it

And our products. in X to as cover reps academic as one of product sending them not departments X with into efficient so institutional center is X an with setting

have synergy, the in services is lot OneCare some invested execution and have as field that we network providers. hub, for put resources are really standpoint. think, capitalize services leverage into move that. of we great and access into But this say, for And And we patients of better the those a I our can a will Rigel making leverage our more sure I so we market. we to be and patient plan distribution something we'll And really

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

acquisition, portfolio. this Congrats very your for on good

key of to for on So your growth. drivers I wanted comment some

this comfort familiarity other with you noted and use, One barriers with drugs. to of the

naive? other team go has is know Genentech, what with had Or some then I do light some And to a with do familiarity that seen help patients -- note, it the their I on in they of are switch? drugs. here with of believe experience lot the So adoption Sprint your you of guess, have

I'll on ask comment Dave to that.

Absolutely, Sure. Kristen.

be biomarker portion Yet awareness product, think do you all look other with look drug we saying have biomarker use that without testing, are in actionable did the over Blueprint great experts an you a over. raising and of the with as that lung targeted job, And companies Genentech space cancer, along or a in barrier, other checkpoint pretty opportunity like what raising FDA-approved with a so an I still products. us at great you a -- when should for a to at that when with chemotherapy that's with of an there. moving inhibitor and actual or that significant and stay awareness

what to it's first more why efficient think the us. for an move as -- that these opportunity. more think we biomarkers We agents of in testing, versus use an view continuing and And line. so And targeted inhibitors call market of identification checkpoint we chemotherapy this more is towards and that's

a will market, that's big among know, lung now we're product been this glad in with has topic -- as actually clinicians quite along the treat that cancer. who other -- targeted on therapies, We you discussion RA

to believe I there the Gavreto. And RET inhibitor noise this requires of fair the the out can we more message And on hear Gavreto, usage our we'll people of just think focus we All get more space. share about us the get.

will for companies. could us. But that smaller for important we obviously, us. not to we So it's have something it. just that's Not focus to And us. it great driver the ability are opportunity be very it's a those company, a important on we believe a think be that We other it why being saying we to

a with the we direction, grow investment place, believe can right the this we And smart the market why tools, so right that's and in really with

a between say And -- seeing the Would of some result you. on line comment you you're TAVALISSE I how different you year lines record as therapies. of by XXXX know Part was compliance much. earlier so and breakdown Thanks can that. a then driven usage of on for was greater that

for Thanks Yes. Kristen. question, that

business our updated more that One data it's setting shared that and the I QX, continue you, had third to I bit we in line pretty who Rigel with have working. in second will that's clinicians we say and on in to or post it's did similar. continuing right just Care. from use little We patients more think previously TPO that More moving And a I focus we that shared think post And the are we TAVALISSE. steroids direction. We're on agent.

positive yet The again. thing response -- rates response to good and better are use responses those about desire to earlier the greater lines leads product is a that

that's So actually circle a virtuous there.

Our next question comes from Riley B. Securities. the line Kalpit with Patel of

real Or lung we how mostly anticipate where Is it in on in patients? you do treatment-naive over in cancer utilization and Do on today any have one Maybe time? color utilization that shift previously treated for is? it is the to Gavreto's question patients the world. mostly

there's checkpoint both use it, but in get reviewed. inhibitors. the second We I with on then line, second -- generally do I research without in don't inhibitor They know the if We And least patients vice inhibitor also that market first front or in is to start in you you the in RET move the data, a usage get RET There line. versa. one. line, or [ to showed have we've chemotherapy mean you in We ] at as uses Calpet. in the

first line patient line, And at second critical patients treated to get so from opportunity. earliest obviously, move as -- that it's drop but out the with you some

our use in what lines, line that's There but focus. opportunity later on the so we're our at is And first is looking more setting. in focused much

both drug off And sales versus relative least to competitors were Okay. same the launched looks between you the us understand but so perhaps like the maybe at it time, the have Got help taken can -- the inhibitor of RET sales your around it. significantly, yours. gap of other the they

I'll on a Yes, Kalpit. comments that, few make

I a approval, second market. to familiarity more subsequent of to comfort and that. second not that's as this is a market challenging to thing it's And with second it's situation. means And was And with to only launched is well lot. first been Gavreto The I part in data said, place market And think market it. second to as

just think first are that clinicians with market And the it. and there and to so of first comfortable generally came very product think I familiar and familiar

importantly -- the first are think pursue. and And we clinicians discussing advantages not that where think issue inhibitor, think we more a a an for continue focused awareness line assess very we getting are of I a difference patients But so RET on and focused us, inhibitor on are to we in in Gavreto. particularly make the the can we'll specifically the with that's just that's RET because who I

treatment of, that, said is awareness thing Dave inhibition RET high, in and the rates testing of as Red good The importance it presentation, as is his are is high. Kalpit of

we XX%. now so ] of a have and its have and And be to nonusers are choice Preben, for to doctors many introduce doctors this product data. these [ it

a grow of there to lot there's opportunity this So brand.

what the should you -- SG&A any for you Okay. some and centers sell about there's products. know already change reps in how Got if where of an much in community overlap this centers? it. And you one question, apologies we cross academic expect increases can earlier, I but said But last maybe that your mentioned

Yes.

these side, community already. still. the already that at we're on doctors looking said, we're most Dave as So of And seeing

treat institutional On versus AML, evaluating cancer for side, that. institutional there's the who we're lung side, different still example. The individuals

long So And the with be X, relative products adds there to not now just throughout that's evaluation. organization ago. something X may some under that

in But additions. minor it many, in across terms will bit. increases we be expect those there headcounts a some to not very be some So the board frankly, of

And study for caped. all XXXX million of along we're interaction all that in, $XX we the GAAP be rental SG&A, clinical with expect for development costs than referred incremental the drug less

floor no Mr. I'd Thank Raul time. like back comments. you. to to over closing further questions at Rodriguez this There are turn the for

to It's an keep to your year Thank interest to questions look XXXX. start been in 'XX this for the and forward updated year, our progress. an on continue exciting and exciting you Rigel start of you and 'XX. We your past

best to year forward going sharing our to you. think I be yet it's care. that look Take with and

This concludes today's teleconference.

You Thank your you your may lines for this at time. participation. disconnect