RIGL - Earnings call transcript Q1 2024 | Rigel Pharmaceuticals, Inc.

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

Operator

Greetings, and welcome to Rigel Pharmaceuticals' Financial Conference Call for the First Quarter 2024. At this time, all participants are in listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

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

Raymond Furey

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

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

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

Raul Rodriguez

Officer; are Financial Dean and Chief Santos, Ray, Schorno, everyone, Thank you, Commercial me joining thank you, and Officer. Dave With for our Chief today. today our

over and affairs us Lisa new our clinical experience to Chief development, in regulatory Lisa Officer. medical I'd Additionally, introduce of like March brings and years to joined Rigel. XX Rojkjaer, Medical

on the to thrilled have are We team. her

their XXXX the reaching mutant X, Slide in of the TAVALISSE of quarter of marketed for This strong the beyond. Medicare for first the co-pays to in REZLIDHIA ITP TAVALISSE is AML product the one in industry positioning bottles hole. first since beginning our new We where faces due donut quarter The net and is Now, with demand a business launch. particularly from refractory due XXXX headwinds our the bottles in distribution sales our high we inventory. typically us continue prior remainder decline and well and started IDHX our and channel year, in is grow for decrease resets commercial X oncology insurance quarterly hematology relapsed to X demand each since products year a products, and or of the or with in remaining impressive quarter to primarily these on

of or product GAVRETO advanced we non-small patients line the with are complete thyroid also and existing acquisition FDA-approved non-small cancer RET to commercial of lung of for cell with July on the targeted remain metastatic this asset this option will and offers well disease. fusion-positive expanding lung commercial GAVRETO, addition, GAVRETO us medical infrastructure. year. with cancer track treatment In valuable a of transition portfolio leverage our growth an fusion-positive RET our We recent cancer. the treatment cell affairs therapy metastatic as in as provide top for

alliances Anderson range potential our a are further in cost mutant of Cancer in to development MD ability manner. and evaluate enhance strategic including time-efficient of the our REZLIDHIA programs, partners, and greatly advancing with REZLIDHIA's Center In we evaluation broad cancers These our parallel, IDHX a CONNECT.

positioned we As our are and prioritize prudent work our financial to well clinical commercial development, portfolio we towards product and breakeven. advance business grow

in to expect We are right which AND bring their patients. believe and announced in synergies have into we to diligently physicians summary acquisition are our Slide Before a and systems and GAVRETO product to product infrastructure transition of complete to of U.S. the our There call to rights expertise. I working people this smooth I'll strong existing ensure between portfolio, July. X, Dave, place of portfolio, a product the over On this turn GAVRETO. previously provide our we to we commercial

the once-daily a in come. with expected In XXXX, to first we of our of issue also payments near of the to in million, and we well Rigel the Blueprint, term. is milestone net partner, favorable U.S. puts with have deal or We are positioned anniversary rights years for to oral statutory Blueprint tiered upon available dates as well million between million GAVRETO inhibitor with GAVRETO, closing as $XX in a program payable first on in GAVRETO $X will net sales this to foothold exchange and of which product purchase RET royalties XXXX includes generated and this sales $XX pay commercial expiration make having established for which The patents regulatory $XX a that price believe upon commercial an issued future market, to the begin U.S. potential Further, is of million capturing from in GAVRETO. date. sale is value U.S. are XXXX. payable to position

product will I the over to provide portfolio. to updates Dave? call Now on Dave commercial turn our

David Santos

Thank Raul. you,

I TAVALISSE our in a First, continued in brief on of on QX. have few to TAVALISSE momentum growing with demand comments ITP,

which Slide for to FDA approved On response a previous patients insufficient or had is see who've immune will an indication, you our treatment. with thrombocytopenia, X, cITP, adult chronic

X have in XX% Over X, demand sixth QX XX% volume Slide demand same XXXX last period quarterly quarters, that, by year. happy and QX, shipped its TAVALISSE high report to quarterly and TAVALISSE Moving consecutive grew achieved record to the increased clinics. bottles patients we for over I'm those to

discuss our bottles sold $XX.X our in net shipped will Dean continued QX. that patients our year has to produce later channel million reduced as sales and double-digit team bottles This are We in of in bottles this after starting were for growth than our pleased full year-over-year presentation. TAVALISSE approval. our resulted XXX less distribution QX inventory. clinics Total to sixth

efficacy We On coverage, and left starts from XXXX, the first shows TAVALISSE The the In breadth demand each generated new growth new the improve patient we focus of since safety growth year. with new pandemic, prescribers, patient with reinforcing XX% than highest the commercial with QX, since and Slide emerged quarter our start is the depth patient driver patient customers. launch. and our starts new our our achieved coverage the graph we that, greater of expanding this through ensuring X, on to of continued strong continued constantly clinical and on TAVALISSE reimbursement continued have starts. after

for our and TAVALISSE. focus impact to continued more to their cITP patients thank entire execution want with I team

both We QX are through new to and forward and how we move patient very that as pleased with the consistent continued our growth demand, has drive XXXX. in in starts

our Moving to REZLIDHIA to now to Slide sales. quarter XX, I'd discuss strong a few growing like minutes take

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

we full the in Moving to growth to quarter of Slide QX REZLIDHIA distribution same ago XXXX in the in in net than sold our XX, first representing million nearly sold clinics REZLIDHIA QX channel, of we QX, our into and the year shipped $X.X XXXX versus year. period XXX triple XXX generated This more QX of launch. sales. QX, We a in of demand sales tripling bottles patients net above was resulting last bottles XX% strong and what of and XX%

REZLIDHIA. are building now by the with momentum very We encouraged we are

our our on XX, institutional from were XX% how of to accounts. REZLIDHIA wanted I patients of you generated to continues to On institutional update Slide and bottles use driver total in shipped be the our growth. clinics business

treaters more becoming data grow more AML. Our in aware continues of mutant breadth leukemia and use institutions are academic depth of relapsed/refractory in IDHX to as REZLIDHIA's

further opportunity REZLIDHIA in prior believe we've As community. have grow an we discussed on we to the calls, use

of are our business, of As and signals has in in stable. a IDHX new aware becoming than AML REZLIDHIA refractory the it starts. We patient treaters our are leukemia X/X see as segment QX did demand patients. drove trend remained mutant also highly trying that that encouraging more community or in This quarterly relapsed their community of

because community patients. particularly feel of to post-venetoclax their diagnosed We patients a use for We believe adoption newly treaters venetoclax-based will significant in regimens REZLIDHIA data among them. grow opportunity REZLIDHIA's remains their of to be AML compelling particularly

team REZLIDHIA's IDHX functions impact our to entire of in thank institutions growing their united academic patients. to worked relapsed/refractory community for hard awareness team closely REZLIDHIA, I They practices. mutant and want broaden as one on work both in AML have across

provide commercialization on Slide update GAVRETO. to for an I XX, wanted plans Moving to our

well with patients fusion-positive as the are with years cancer FDA-approved On refractory. by the non-small fusion-positive of advanced for lung Slide and cancer thyroid cell or systemic as I'll and of older indications patients iodine begin treatment pediatric XX, RET RET radioactive therapy age metastatic adult XX GAVRETO, which adult include who requires who reviewing

Slide Rigel our strategic to believe commercial want to portfolio. third therapy an in as reiterate I Moving important GAVRETO addition we is oral why FDA-approved XX, targeted the

fusion-positive million from meaningful recall to opportunity GAVRETO this continue cancer U.S. year, you'll advanced non-small generated for As net thyroid providing Raul's to and RET remarks, in patients cancer. last so $XX is therapy us nearly excellent lung cell with sales an

clinicians move with large We immediately believe testing already are reasons. biomarker associated solid recognize market opportunity few FDA-approved patients a immediately to a well where Number us a one, therapies. tumor our business for RET most GAVRETO suits enables this compelling efficiently it and and into as

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

access access we newly strong believe we GAVRETO. capabilities ensure prescribed two, fully have Number current have patients that can to built and we to leverage

GAVRETO, with that RIGEL ready providers. efficient our to as being established services and hub customer-friendly a patients has reputation distribution to accommodate Our and will soon REZLIDHIA for and be will TAVALISSE highly ONECARE patient responsive network

GAVRETO. have difficult-to-treat ensuring that targeted for a to plan also record in coverage of oral track diseases with therapies We and continue we strong reimbursement

complementary accounts, practices. both this with accounts. footprint in more within number With time multiple because already in our highly And both as three, these teams oncology discuss centers the call to we products be for be one have these medical is affairs we'll makes we us able it and on community and efficient even our academic who commercial and a to perfect opportunity Rigel resources place sense

wanted I and GAVRETO, our right to side is luncancer. slide, On the biggest of cell that with opportunity in highlight non-small the

cell of each approximately year RET this cell last of the X,XXX for you'll lung shows The the were patients to with X As fusion-positive to treated fusion-positive approximately were translating X fusion, patients the graphic inhibitors on prescribed that eligible first-line approved cancer patients positive patients for treatment. were recall, RET inhibitor. in year X/X with RET test of year. therapies XXX,XXX in X% X% cancer the RET non-small RET a will lung patients used research GAVRETO done X/X non-small used the about of who FDA

with being RET patients Importantly, opportunity still of the this immune chemotherapy a inhibitors there or X/X the is for inhibitor market treated GAVRETO. approximately an checkpoint without or multi-kinase of inhibitor. X/X We view growth and by as

reviews the what we continued our drivers as GAVRETO. commercialization growth XX are journey Slide believe begin we key X for with

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

being them clinicians an Fortunately, biomarker patients fusion-positive XX% therapy. FDA-approved do of as RET with for even recognize aren't RET the immediately test, when specifically if looking about they associated

When in We inadequate treatment and about available. delaying more Also, that lung about of biomarker biomarkers for tested, year, non-small cancer, growing, due education tissue cell last concerns addition lung not patient treatment. don't especially allaying testing, XX% cancer. data in cell with Both of such while test, clinicians non-small of waiting significant that, delaying in of to and it improving. test targeted patients appropriate testing non-small clinicians' is cancer lung HCP the to cell in tissue And ALK EGFR are likely early-stage adequate and will being results. expand having research biomarker are patients cancer identify even adjuvant testing importance believe recent therapies on HCPs about and barrier that's targeted and for rate therapies top is and the approvals in as conducted being portion further the test concerned lung to a are for

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

and the represents can immune From the growing use once-daily use GAVRETO's among multi-kinase testing currently of prior more with grow future RET-targeted therapies number moving decrease, a oral concerned we with first-line about patients. use in inhibitors treated initially treat resulting are agents of delaying clinicians By educated we awareness about chemotherapy dosing, targeted of in the safety clinicians the And inhibitors more and the lung and the believe importantly, efficacy, believe who nonusers. cancer, with nontargeted non-small or or in therefore impact we of other GAVRETO of treatment patients slide, treatment RET will GAVRETO. about as fusion-positive to fusion-positive of regimens treatment without cancer a lung are chemotherapy-based current like X/X of checkpoint cell therapy RET and

her impressive persistency and to carryover duration These and that of grow rates, business of patients month continue refill will once-daily efficacy presentation. prescriptions. grow as Lisa response data discuss GAVRETO other in each dosing. these to believe to should long we drivers continue convenient Third, response due high GAVRETO important their its will our

And coverage, as difficulty obtaining as strengths finally, RET reimbursement can costs from believe the as for we we leverage gain GAVRETO barriers and and services users reimbursement RIGEL inhibitors. clinicians have who ONECARE, of patient use out-of-pocket we view with our loyal discussed, in we

summary, in are positive positioned well GAVRETO continue momentum we to X growing drivers. key In through these

Rigel XX, to access newly RIGEL in the is and ensure to preparing patient Genentech progress have ONECARE network ONECARE to made therapy. transitioning working experience continue no to from ensuring with continued On Slide closely both Blueprint and programs, interruption. and providers network without with RIGEL to GAVRETO prescribed current patients and in we access Genentech the to patients interruption to programs work assist patients existing have

and supplying is with their patients we everything RIGEL in Our will distribution July. and that network report is support the staff for fully pleased Rigel ensure dedicated where track prescription in access am and I GAVRETO have ensures patient clinics service. and begin level highest to provider choice to on filled, customer to ONECARE to GAVRETO

of And Slide up with update to the our GAVRETO plans the I to for our line time wrap wanted just XX, rest of year. high-level

track of access RIGEL market preparing in is progress prepare for our team the Our quarter made on for and and in everything ONECARE network GAVRETO QX distribution excellent this addition our the and of teams GAVRETO field transition. will patients. and We July, will ONECARE begin for that, and shipping anticipate current patients RIGEL we in clinics, prescribed this transition GAVRETO to majority newly to

simultaneously the in accounts on will update community particularly bringing our calling with our portfolio customers by on oral on teams into patients as the an continuing moves current GAVRETO. we in have field focus discussing Our the look nonusers, to with breadth GAVRETO that and users of GAVRETO on expanding begin QX, forward a It therapies, progress I targeted Then, prescribers and will of year will be you ahead. to our setting. exciting year continue

to the to Now, have Medical we I'd call I'll are development turn how and over now update on to our also thrilled activities. our Lisa. us, for her with Welcome, Officer Chief like say new an

Lisa Rojkjaer

I'm afternoon, joined our have for Dave, inflection ago we a months and excited and oncology expand point just couple important Thank to at good Rigel portfolio. hematology of an company the everyone. you, as

to we I'd medicine about GAVRETO. patients underscoring approaches patient fusions lung perspective, cancer begin are those First, the by from precision like why, are outcomes, to clinical and including excited positively with how RET impacting

cancers, cases RET patients XX, around representing the X,XXX per of around Slide of approximately cell On in then in approximately fusions U.S. for papillary all year per are new cancers and X% year. thyroid non-small present new XX% lung X,XXX

lung non-small of cancer. for evaluation part is pretreatment the fusions RET Testing cell an of essential

eligible as recommend practice as cancer therapies harboring patients the targeted metastatic lung treatment with first-line variants for cell fusions. fact, In genetic actionable clinical RET non-small such use of guidelines

of here non-small nonselective regimens response X of advent anti-RET progression-free efficacy use rates the checkpoint limited of to with range cell multi-kinase low shown of and have median immune months. patients XX% RET efficacy The lung range cancer X Because overall and chemotherapy inhibitors Prior rates only with with XX% received fusion-positive RET-targeted toxicity. survival cancers RET months. high expression, less modest progression-free overall cell the than non-small to inhibitors X therapy, with in treatment-related rates exhibit in X fusion-positive response and activity demonstrated advanced of only lung PD-LX the has to platinum-based survival

an therapy. is thyroid dosing highly oral, or first-line with GAVRETO RET lung subsequent-line fusion-positive potent, once-daily RET for selective non-small FDA-approved inhibitor as cell that or is cancer cancer

from I/II data from a results expansion study the date I/II review Phase On updated XX with in summarizes and ARROW Slide date will led of clinical sites original March ARROW XX conducted the data was This an updated which data XXXX. cutoff the with at clinical next the to open-label escalation XXXX. I May approvals. multicenter Phase XX study, of dose study countries cutoff slide,

Pralsetinib patients Phase to milligrams the Pralsetinib other be RET at fusion-positive cancer I, Phase cell rate. dose. recommended solid In with tumors. daily RET efficacy The in evaluated of daily In milligrams XXX the response was safety thyroid XXX II a non-small advanced and II, fusion-positive of overall and cancer, Phase primary dose was was endpoint lung determined

with RET cancer subgroup, secondary was overall with In all solid was patients In duration of achieved to patients XXX endpoints, with median In a of irrespective the finally, XX% These events. cancer the non-small response, XX% response adverse activity thyroid key the was tolerated platinum-based lung well previously in therapy tumor XX% XX.X And of cancer, was therapy. thyroid overall with toxicity XXX generally of of chemotherapy the patients, The the of response treatment fusion-positive months. untreated results and RET observed one subset of response. in Pralsetinib RET-targeted cancer. rate previously with XXX only patients of patients discontinuing patients RET therapy non-small with cell patients. fusion-positive XX% XX utilizing with later lung to prior or Pralsetinib XX%. in lines subgroup in cell and subgroup low-grade was the lung treatment-related the previous XX% with of overall predominantly tumors, fusion-positive in benefit shrinkage first treated due treatment-naive XX underscore for clinical observed patients

the diagnosis, XX lifetime. of brain at brain in over Slide of with seen XX%, a non-small of response Overall, rate RET-fusion with the which was in ARROW were will XX% metastases Moving cancer X study, time the of approximately course intracranial positive of XX, high have of In present response was patients patients patients. the their develop to median cell brain duration metastases metastases, patients rate complete XX.X are for patients lung XX% and responses months. the and

and On activity reviewed, Slide has that and data, demonstrated patients gene proposition. favorable patients Pralsetinib we non-small a cell It's these with rate. history. XX, thyroid treatment in only lung prior Pralsetinib based value inhibitor and established metastases is associated has response believe RET the of spectrum of profile discontinuation Pralsetinib approved has cancer low an regardless brain intracranial activity a considering differentiated and we with once-daily durable promising for treatment the adverse with manageable also prior previously on oral with events fusions. When RET with approaches rates safety

a is with lung treatment Pralsetinib advanced non-small for cancer Finally, thyroid cancer. RET and fusion-positive option recommended patients cell

the into for product target summarize, a portfolio. that differentiated and to fully Pralsetinib our integrating we patients, treatment is to look we So option forward believe

hem/onc I like of development collaborations our foster our research growth continued provide clinical programs to now update which an and pipeline. would on

our oncology hematology to to we and Moving to focus XX, continue Slide our pipeline. expanding strategy shift

evaluate collaborations as Cancer has further syndrome, or AML or such Adderson MDS, glioma olutasidenib, focused IDHX We MD new indications. role, number inhibitor, in Consortium. mutated either First, a of development a the in believe CONNECT on Center olutasidenib where these we've the and into in monotherapy indications, additional plays we combination. myelodysplastic cancers as into olutasidenib segments, To are and a potential clinical IDHX our strategic entered advancing with

continues to We're into lower-risk X/X first part have with trial our trial, preliminary MDS. data Enrollment year. and this RXXX, the our novel in Phase Ib this we in of expect also IRAK later advancing inhibitor patients

we would for addition, or in-license opportunities on products In our a that remain fit be focused acquire to portfolio. strategic evaluating potential

data, products products data, We our are have and that or products are or hematology, advanced, areas, can late-stage, oncology, more registrational looking differentiated infrastructure. for in that hematology soon with and possibly related to leverage oncology registrational

that with demonstrated and acquisitions to with As continue are our assets Pralsetinib, and ability pipeline execute. our is fit goal strategic to our organization, of olutasidenib to a find

First, other are evaluate to AML, into a advance we're Center very mutated Cancer MD MDS. the with planning olutasidenib and to development and started higher-risk we in olutasidenib our with MDS combination first-line collaboration have pleased beyond. to in more Through Anderson partnership, broadly IDHX AML agents

the in plan evaluate a olutasidenib setting. up with the CCUS, with an to clinical a also developing risk and potential That's $XX years. We to maintenance condition X trials of increased MDS, on MDS associated post-transplant as horizon million lower-risk and paid over in monotherapy X

conduct a trials look forward Anderson these to position we as with us collaboration progresses. to expect subsequent our providing MD working and to trial, or updates trials, and registrational We

mutated with important mutated glioma. II in translating approximately high-grade IDH IDHX approximately to Moving XXX is of conduct in in XX, Gliomas X/X CNS a adolescents X,XXX cases of gliomas, XX% patients tumors around -- each adults children, Phase these and with to Consortium have for U.S. we account Slide the CONNECT development collaboration to with trial another new the young year to being

high-grade XX%. in are pediatrics adults. the up Despite and cancer-related adolescents gliomas less than young gliomas mutations and of X-year found in X% adolescents adults. of leading are death High-grade survival therapies, XX% to population IDHX cause this of young a and of in approximately available is

Phase Rigel-sponsored preliminary olutasidenib reported. patients gliomas clinical glioma. we of refractory mutant patients. in high-grade study a to approximately The that Based recently intends included a trial cohort CONNECT In enroll or CONNECT's guided olutasidenib Phase for these TarGeT-D indication, will were and IDHX XX the II safety on single-agent in XX and patients IDHX the with and the are newly that followed first receive radiotherapy, of olutasidenib primary in with XX by diagnosed olutasidenib will younger young arm, and second with temozolomide high-grade temozolomide monotherapy anticipate year. mutation-positive glioma year maintenance this therapy progression-free after olutasidenib adolescents combination of years II relapsed old are believe and olutasidenib to without tolerability activity and summer. umbrella safety survival. potential and The be has trial, for with objectives with The evaluate data, the to open-label this high-grade initiate trial We in molecularly for

provide excited over We to funding olutasidenib's to are We, million patient underserved $X will up collaboration. X-year the of study to treatment in with provide new along population. potential much-needed material about option CONNECT, this a

of And about MDS. in tell Slide I'd area trial the high infections IRAK dependency inhibitor, in RXXX, cytopenias, Ib particularly to which increased and dual This a is another unmet patient finally, progression a need of of acute resulting primarily risk to in evaluating and like risk patients in transfusion population anemia, Phase on we X/X elderly leukemia. facing novel are lower-risk XX, with our progressive you

patient's risk therapeutic for The MDS upon classification. depends the strategy MDS

has RXXX this an population. issue. of MDS of becomes MDS the lenalidomide difficult the for hypomethylating needs options patients, that potential toxicity agents, more attain deletionXq second, of erythroid Luspatercept approved in are currently are cell to no patient address lower-risk with agents. patients believe therapies the unmet therapy, There responses the abnormality. that durable lower-risk treatment in those first-line For use have to later lines and for and red stimulating include And We transfusions, failed

only and about involving leading leading IRAKX IRAKX of persistent signaling pathways a like Moving associated regulation were of signaling with I'd differentiation to to recently RXXX. and the also of both Slide highlight co-targeting leukemic of X/X hematopoietic cytokine toll-like XX, an is The healthy restore twice-daily this tolerated why RXXX, is reported now preclinical RXXX, chronic cytopenias. activation to inflammation, well in pathways In pro-inflammatory inhibition cell RXXX, cell occur suppressed MDS. function, supporting volunteer study to independently and IRAKX, and both is studies, dosing suppress we production. marrow Clinically, MDS once- This and that stem far and and inhibitor, environment converted concept. is with required pathway, thus Phase and to in with MDS. AML rapidly IRAK modest Ib fully pro-inflammatory IRAKX and progenitor dual and this are prodrug of in to MDS hematopoiesis shown was receptor inflammatory a stimulation being excited the IL-X And immune oral X activity have and in to that a evaluated inhibitors lower-risk

later Slide the dose study XX Ib relapsed/refractory are anticipate Based we twice-daily for cohort X PK. enrollment a expansion trial study, patients and multicenter dose first well. year. data part MDS this dose the primary from The from have third safety. of presenting standard Phase to design of selection endpoints the phase of the phase and recently continues for recommended on rates design in regimens. with dosing included The in the with of open-label X+X response progress the ongoing include additional with our shows has expansion the endpoints RXXX confirmatory data emerging levels lower-risk escalation we preliminary for dose We which a and completed secondary this trial study safety and and

results Lastly, XXX or end trial progressing to key an is Phase penetrant the cellular referred RXXX inflammatory being advancing XXX implicated of Lilly. anticipated on tumor patients XX, Phase processes adaptive RIPKX plays Slide IIa studied up clinical and our enrollment year. inhibitor, are Ocadusertib, currently IIa factor the of RIPKX is well active our partner, previously of patients IIa/IIb of our with well with range a with moderate-to-severe in broad to as programs is LYXXXXXXX, preliminary in in Phase role approximately rheumatoid by analysis the non-CNS necrosis arthritis. in signaling. inhibitor RIPKX a

lead RIPKX also CNS-penetrant nomination. inhibitor preclinical candidate progressing Our program towards is

We about RA are programs diseases. the excited CNS and their our broad and and of immune progress potential in other

the growth joined expansion our and I'm programs. of and excited of I forward to our to development Rigel at oncology conclude, this progress portfolio. hematology look in contributing To time have to

the turn over now will to Dean. I call

Dean Schorno

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

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

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

We TAVALISSE of remaining decrease the at detail reported the XXXX, X% first XXXX, I this the to $XX.X describe distribution in in in on of the channels more in net product resulting in quarter. bit decrease the a sales end next will from our in million the of period bottles compared same slide. a quarter

compared net from of product same reported quarter million $X.X sales $X.X in million REZLIDHIA in XXXX the to We the of XXXX. first in period

XXXX. the in was of As reminder, a launched in United States REZLIDHIA December

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

gross REZLIDHIA and and of product was For XXXX, for approximately sales, XX% our XX% TAVALISSE gross-to-net respectively. the quarter of first adjustment

of bottles to REZLIDHIA. net product to to of TAVALISSE quarter both our on move continued shipped second expect strength with pleased expectations and XXXX. review clinics let see for and our growth patients sales, and the me We're we for Before business in the

expect XXXX gross-to-net quarter XX% TAVALISSE adjustment of in REZLIDHIA. for approximately XX% for approximately and our We be to second the

patients bottles and highlighted, metric, quarter in in saw of This is bottles. million highest a clinics. net key which saw the fourth for bottles, This a of XXX demand distribution bottles review our XXXX to of sales. and Slide we total $XX.X remaining bars, quarter. volume for sales as X,XXX product quarter generated launch. saw before in XX, the dynamics want the fourth decrease orange On move of net the we a I of to brief I Incrementally, demand the we since channel product to in provide quarter, Starting increase XXXX, our of significant Dave in with during the sequential shipped review on financials resulted our of bottles X,XXX the

X,XXX new bars, first is the typical to quarter delaying and saw co-pays associated challenges with the increase resetting we and our XXXX, quarter both to both industry year. prescriptions clinics. and Medicare donut refills green patients discuss the each the Now, shipped and industry small we of This that hole first bottles despite of experience the in

demand You'll resulted note in in thin in in product this increase sales volume the that small net sequential of bar $XXX,XXX. a increase green

of million, business to our XXXX, sales are variable, levels increase X,XXX thick them net to from inventory impact inventory sequential in reduction distributors at of levels the sequential XXXX, graphic. sales red X,XXX of reduction QX generally distributors. from this of the bigger bottles The but in at we QX contributed in distributors our The our reduction in as at net down Inventory end do bottles our product to of $X.X our in the grows. a over decline bar product this came at time of expect

provide our To illustrate me net example. in the levels effective on change revenues, let an inventory

quarter-over-quarter While second flat said for the adjustment. intended that and of continued price would with levels TAVALISSE approximately and calculated that as that clinics we expect to if wholesale is our calculation demand gross-to-net current be first illustrative. we XX% expect for of quarter growth of are to this to to compared XXXX, This levels is quarter see anticipated patients Again, our the in we volume shipped see XXXX. bottles growth inventory and to assume inventory are and we both have variable,

from On from from and the of first addition to in $X.X million XXXX. Medison. Grifols million from slide, to collaborations net our next revenues from Kissei, $X.X $X.X of million Contract revenues in quarter collaborations were $XXX,XXX consisted contract sales, the product

trial our cost Moving [indiscernible] to of due expenses expenses program clinical activities IRAKX/X clinical costs patients was Phase timing related first compared COVID-XX expenses, to with costs research fostamatinib decrease decreased inhibitor in and on that the and to product in costs III X [ trials trial period development same ]. and well the the Total completion million and ketolycaemia $X for related in $XX.X approximately of as to the and as $XX.X of timing million of of XXXX. quarter activities to to were sales for The was primarily XXXX. due million costs

due also costs. by partially was as and decrease lower These higher lower services were expenses stock-based the performance-based awards. addition, offset decreases to third-party In facility-related consulting as mainly compensation well from

and ended future. We million. cash, the $XX.X the focus our cash and investments equivalents of quarter to maintain short-term with We look into financial disciplined approach

Financial. Lastly, entered credit an to with our in amendment into we April, MidCap agreement

by the an amendment, date, interest-only X of part period, we the year. As maturity extended

QX principal extends starts XXXX period and XX in Our months. now for repayment of

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

Raul Rodriguez

you, Dean. Thank

XXXX, the TAVALISSE of of year. adding to this continuing on our to of we to Looking are grow sales REZLIDHIA in commercial and July ahead operations focused remainder GAVRETO while

additional will Phase of with continue enroll and similar And forward GAVRETO. and company. making preliminary RXXX evaluate and Rigel to to REZLIDHIA we opportunities committed Ib help expanding business, hematology self-sustaining lastly, clinical for strategy we strategic -- towards oncology olutasidenib our remain look trial a the data studies, as other our MDS. our the and our clinical development we our we to will from initiating of strategy and we breakeven also actively And of will We'll and we pursue to acquisitions grow financial With additional execute deals collaborators, generate in working our lower-risk in-licensing on products.

questions. first interest we that, Operator? With the for your in call now thank you open I progress to And in quarter. your our will the

Operator

with from moment Nochomovitz One is first Instructions] Citigroup. [Operator first our you. the question. And line of for Thank the please Yigal question

Yigal Nochomovitz

guidance, the burning you're $X cash On million about quarter. a

picture breakeven as help us the revenue burn through getting activities. to You walk mentioned just Could far investing existing path and the as the and you in portfolio? well to in getting investment as the the breakeven as in-licensing also to

Raul Rodriguez

comment on Thanks, to Yigal. add that, on Dean ask I'll and I'll to that.

Dean Schorno

Sure.

So as did our In we as quarterly cash top to last guidance. for haven't a XXXX describe expectations general a encourage some line it look forward, call you look relates OpEx. then, from as the perspective, of couple And quarters. we back quarter given comments to we our and I'd current burn in March,

available. that's So

couple note that One respect to of the things. described. With I of net the I dynamic is QX, would sales a

reduction, in inventory paid sales, I as our So of that. paid a the result our that note which million, MD $X cash Incrementally, also we would million net Q. the $X collaboration. on Anderson flows impacted we impacted have is and this We did

So that a burn cash from into elements that flow perspective, there's described. you of a variety going

future launch and see do quarter. look the million revenues that continues and of of than to increase. that in With start of to spend SG&A to we focus our financial breakeven, GAVRETO. and $XX we revenues third a we've to that, expect with to respect respect business, recognize GAVRETO to With We believe less point be that the described clinical there's

rapidly we believe become accretive. will So that that

believe exactly said, will just provided we're that haven't breakeven. when that we the occur. financial path All We to to a on guidance say

Raul Rodriguez

Thank you, Dean.

Yigal Nochomovitz

each? you they, then interesting the curious as ratio, question, the brain for if and both for to the on glioma have plasma on the comment GAVRETO switching brain-penetrant a brain I'm drugs? you science Could activity it's how your on -- in of you details Just clinical that whether are for just as interest well regarding have those olutasidenib. information curious.

Raul Rodriguez

Thank question. for the Yes. you

cross which able very as as think helpful. clinical and studies for olutasidenib blood-brain that crosses been we also GAVRETO, is critical, in discussed, barrier, the show we've it's they know also well to as Clearly, Lisa I BBB. the

and molecules about on both of the based which helpful. on GAVRETO else, is very Anything ARROW in excited trying we're generating so of area, obviously, the those data opportunity study, already the Lisa? And this

Lisa Rojkjaer

would ratios you're been say asking actual determined. aren't that about, known. the though, that That I Yes. hasn't

Raul Rodriguez

there's we a that But effect know of therapeutic both...

Lisa Rojkjaer

Absolutely.

Raul Rodriguez

meds. a Lisa this, the patients in that with already highly [indiscernible], study were smaller we one in studies, And a showed the on did benefit then publish, relevant refractory. ARROW brain ...in and referenced study that

Operator

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

Kristen Kluska

up Maybe indications? can ask about these also each talk follow pipeline? different way, which where then to going in bolt-on these assets more the evaluated the how itself in appetite be of fit to one you're you of other for deals potentially your continued and balance could in last the on pipeline a current And

And from like, years X you now? in where way see is, maybe company to maybe another ask it do the

Raul Rodriguez

may. at crack a I take for me appreciate if that. I Thank that, question, Let the you Kris.

the excited and that in to demand to really basis bottles have quarterly terms of in were, a very down quarter last huge in even the of continues we're grow and TAVALISSE, and So high, in on up fundamental growth quarterly And the nicely. go QX They other again, QX new and of excitement that's the basis. a TAVALISSE the product. were way. mean, Inventories I last -- year of

of therapy, excited And introduced And it's tremendous being organizations, because as the the well. the the oral of sales in launch REZLIDHIA, having we make bag community, headway And ways, and with to in there's of addition the products all just where and those. GAVRETO, really can X targeted underway we're again, is -- institutional our good with still clinicians. think of there product opportunity many

look we grow continue line very to So top nicely. the for to

growing, was That line. but relatively OpEx things. We look -- X the also be modestly to for can top more the much than more

said, the And our terms That year. last still quarter Dean as in we of guidance, gave of some holds. view

we business. area this on in put clinical could future now those with from evaluate, sufficient increased do looking in the Lisa flows on at generate we exciting we're have together, the and this resources able able area in in trials terms to in glioma, of years to be and her and to And ourselves. to like ourselves. able And We're delighted very opportunities, things being areas [Eluna], with then execute us cash design based AML that particularly ongoing us experience so be to launch see help to which very various us are studies

grow And growing of been REZLIDHIA sequence, importantly, have very, into of the studies much tremendous. I The want to terms the in other in increments and, more of addition also reaching that more, products. and clinical the oncology-oriented generating our then we're terms and then continued continue infrastructure growth to and terms GAVRETO. registrational able products, that. been that to we've acquisitions of an in-licenses really in and community-based organization that leveraging these of place. with useful financial each that fairly result further business. and cash We the fully of very line is is It's excellent to studies top clinicians, be both to think, in do small ability sell institutions do the X that all And along we of able to infrastructure to on or in leverage subsequently breakeven own, more have

years, So years see sure we X beyond the for how that's growing and in the few next business that.

and externally growing are business, do a to AML [indiscernible] so addressing it's we exciting continuing that without to on having add very think at glioma to exciting may very have able the for areas much, increase major that look to our to in that base be products additional then launch I trials and infrastructure all. if

Operator

of with [Operator Instructions] the Haque from Our question next Jefferies. line Farzin is

Farzin Haque

but variable the So should is really based think numbers channels it? how Like, distribution of this the rest we for TAVALISSE, inventory for XQ, is for the And in showed about variable across the quarters? you on just XQ the how it levels, year?

Raul Rodriguez

variability Yes, I'll the look to place can that. Dave another can at point and ask that, comment you to of you then on we

David Santos

they our We kind through as network bottles. of inventory inventory do I have terms to quarters. of QX to distributors, variability unique a out was again, either And X they that's of what's of sitting the us. distribute direct sell the the in the And of XXX the SPs, say why purchase which bit is accounts explained inventory patients. I will Yes. in Then from inventory. Dean which it's those believe our -- understand and question of left your that because we drawdown distribute to or portions

they went think the of in key did bit that down. QX, kind And I little is that, But more so a in QX. purchase

growth inventory example, last sales. demand, terms year versus in of in even flat his as kind and build demonstrated stay net double-digit this of we quarter don't any if But Dean we're on expecting we

variability, usually a then the ended around think why quarter So Dean in little that also, And demand the QX high was we you is I And purchases holidays increased that we with happen, but And in quarter. demand, expect happened wouldn't continued start this bit the significant the reflected we lower out demand. with QX. very the does which early our into mentioned, particularly moving with as quarter-over-quarter. quarter

don't think number variability but my that particular significant contributed And would there's but any to view. see this forward. that, we down up in I as clarity invite quarter, we this on Raul of that's variables to or I more a So provide drawdown, move any

Raul Rodriguez

we cases, I have Yes, think seen, in some larger highly numbers.

for 'XX, We've drawdown this early fact, the a had example. larger In largest. one wasn't in

it So does vary substantially.

I is think is TAVALISSE term, what we It's consistent. growing. And grow growing. is the one consistent, that grows. though, not the business quarter, the It's just a or quarter overall business longer any levels in sides. oscillations trajectory and when the as the in in is inventory both see any growth is specific trajectory

a numbers include you nice quarterly table back In as early if our could as that basis, wish. deck, has quarter going to as on little XXXX. we inventory corporate changes a some prior I share the well,

Farzin Haque

Helpful. a for you REZLIDHIA, And then uptake. nice had

patients? proportion to of then sales with new And novo what from were to done needs what better existing wondering the de So [indiscernible] in patients the compete the versus be patients.

David Santos

patients demand you QX. And actually, the who who patient is in started. as demand I you percentages still look because, number get know, from pretty did we And at of strongly that's max X months And March. the you if institutions. only to strongly showed a bottles, in Sure. our Actually, have starts previously total you are patients have from toward bottles a business similarly, started

a had of small have number would bottles. this So only

around have the in percent were of, bottles percentage new the but it's say, exact around percentage, I don't in of the So QX. XX-or-so I'd patients

also think think sign, That excellent clearly started last from that the obviously, that growing seeing we -- more an so I that's sales. patients patients new And you're in drove carryover But year. new QX. what is

disease. of olutasidenib have terms a trying we would terms response look differentiate and we in in who've very in there. say competing. secondly, IDHX out And tell getting just we And really have story That's are response. wouldn't I of -- we're mutant relapsed/refractory the We that venetoclax, of feel response. duration say rates long a to we of then had I in there believe subset particular, when to at previous you patients duration great of

So you're that first-line to think, particularly population, venetoclax consistent venetoclax-treated about the to and talk a as relapsed/refractory in end pieces to because, those when probably the and response about response of grow the at aware, compelling continues you clinicians very day, use, duration setting are That in the have in have duration. a of the we talk becomes AML. rate I able you're -- that then

Raul Rodriguez

Thank you, other questions? Any Farzin.

Farzin Haque

No.

Raul Rodriguez

Okay. Thank you.

Operator

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

Raul Rodriguez

interest commitment forward Thank lives as patients of that, like and like have thank in I'd look every to on progress. you. closing, always, the employees our improving in to our a you calls. your In single count. on because I'd day. great their We continued day updating this to with And does thank our progress Rigel for future to call everyone for And

Operator

today's concludes This teleconference.

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

Rigel Pharmaceuticals (RIGL) 7 May 242024 Q1 Earnings call transcript