Rigel Pharmaceuticals (RIGL) 6 Aug 242024 Q2 Earnings call transcript

Greetings, and welcome to Rigel Pharmaceuticals Financial Conference Call for the Second Quarter 2024. [Operator Instructions] A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce our first speaker, Ray Furey, Rigel's Executive Vice President, General Counsel and Corporate Secretary. Thank you, Mr. Furey, you may begin.

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

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

Dave today Schorno, Medical and Officer. Ray, our Chief our are me you, thank Commercial Thank Santos, Financial with Officer; joining you, Chief for Dean Rojkjaer, Also Chief everyone, and Officer; our Ms. today.

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that, I'll to the over turn Dave? commercial with to provide a Now Dave update. call

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Thanks, Dave.

We Slide continue hematology outlined strategy to our pipeline. Moving to expanding and XX. our oncology

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

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

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that pralsetinib, in and our and renowned well diagnosed execute. To as to a to advance for more first off start evaluated align assets development is As disorders. other demonstrated for very continue to combination find our academic in MD and XX. beyond. partnership, other ability care Anderson the pleased as Cancer of goal and We're agents have with IDHX-mutated with newly in olutasidenib to on myeloid cancer Center pipeline olutasidenib will patients collaboration broadly with with AML AML, be research to time olutasidenib Through the this internationally organization our acquisitions Slide into MDS

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

of our conduct patients. for you'll will XX, expect of to see decitabine We IDHX with and that enrollment. On excited subsequent focus olutasidenib the recommended venetoclax of of collaboration find is in the efficacy to evaluate venetoclax is can regimen I'm registrational under newly decitabine, The that in given II. a combination position IV and Phase diagnosed research determine as to a open trials. And II complete will AML oral share that, to these trial The Ib patients the part mentioned, with rate primary in Raul a us trials first safety now and the patients mutated in remission combination to be dose Phase AML. Phase be combination and is olutasidenib objective a or triple in open-label that refractory relapsed to this trial the Ib or Slide Phase trial

of this will be chemotherapy. trial sharing to exciting kick decitabine, combination intensive it lead study updates an forward to excited include the and study are are As all-oral MD that has to off potential progresses. for very formulation oral We for an AML an would ineligible to the regimen, and Anderson patients look this which as development

Moving to Slide XX.

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from concept. suppressed that this ongoing RXXX resulting This dual progressive the anemia, a development Next, program in believe thus a IRAKX/X needs proinflammatory IRAKX/X X volunteer oral dose and also associated rapidly novel primarily update chronic Co-targeting persistent that marrow I'd Ib is infections MDS leading evaluated gut targeting expansion inflammatory of is lead and regulation to a study recently X potential and escalation is the primary hematopoietic a IRAKX, RXXX durable Based in is progression for regimens with IL-X relapsed design modest and pathways activity safety patient secondary expansion particularly levels. progress difficult like of inhibition of second leukemia. twice converted population of clinical the mostly cell the selection lower-risk inflammation lines XXX RXXX data with endpoints and and cytopenias. MDS. of risk environment are RXXX and cohort fourth MDS and another continues inhibitor standard confirmatory this Clinically, cohorts more issue. We restore to signaling an the only signaling. cytopenias, rates dose pathway RXXX. shown XX IRAKX dependency may year. with dosing toxicity the pathways independent transfusion-dependent unmet X+X anticipate of of study, risk completion. own studies receptor risk immune with of the the this twice cytokine enrollment healthy attain to a facing in has in to and and patient inhibitor, present from response now to these options emerging dual in which we've IRAKX will MDS to total and may IRAKX has is X MDS, pro-inflammatory with of toll-like and hematopoiesis In in design our the this the shows refractory Phase endpoints for to dose dose and fully dose both preclinical address PK. activation are with of IRAKX by and to stimulation that AML this trial In The suppress additional of production. and Lower in now acute MDS limited. later inflammatory involving being unmet for a both Study phase the for part the an of of differentiation. our safety. this data of in Treatment trial progress area from that have recommended high far are supporting daily on population is level transfusion elderly our include and nearing need well lower-risk daily therapy, responses inhibitors and in increased We and becomes patients later open-label you milligrams of included lower-risk prodrug X on first MDS. Slide patients we in for RXXX, preliminary

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

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for I'll to the to discuss call results the Now, quarter. Dean our pass financial

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

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GAVRETO XX and mentioned, Dave in is XX count bottles. available As count

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TAVALISSE, Our returns, $XX.X sales rebates, net net GAVRETO copay of of estimated product charge other and were allowances backs, and discounts, million. recorded assistance REZLIDHIA from

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

review year-over-year move of for net let our on continued product the from third strength the to growth pleased our and me strength net business we see our Before expectations quarter. We're in with rate. sales sales, product expect

gross third for the quarter, approximately of For slide. sales, GAVRETO XX% XX% be On the to to respectively. XX%, to net our and next product gross adjustment we REZLIDHIA expect and TAVALISSE,

in the $XXX,XXX from from million million of revenues quarter. from to collaborations net were from sales, contract Medison. second In and $X.X Kissei, $X.X our from revenues collaborations million addition consisted product Contract $X.X Grifols

costs on expenses. and to Moving

We $XX.X and cost Increase is cost and higher was the quarter Our for sales, XXXX. driven amortization, expenses cost by partly for of million personnel-related million due product that, RXXX period disciplined increased due in of the I'd to the and focused primarily $XX.X million. clinical like Raul? were equivalents expenses activities, to development turn the with million compared $X.X over short-term same of to maintain our future. With inhibitor IRAKX/X in cash costs our research costs Total progress royalties, look approach call intangibles the investments into higher XXXX. product and sales ended We program. increased to approximately of and to cash, costs financial second back and including quarter to our and of the $XX.X Raul.

To Thank across good position. this conclude for areas and commercial you, a all including quarter portfolio, was development very product sales Dean. financial Rigel. our of and We progress our made significant business, hematology/oncology pipeline our

For each share of will the our and these I summarize outlook. areas, quarter

record our growth GAVRETO First, of with to commercial delighted business. REZLIDHIA, we added and sales third for are we portfolio. product, achieved We and our commercial a TAVALISSE both the

As half we focused momentum, growth line. positioning second look continuing XXXX, on are the the into us we sales on of top the meaningful for

great did with both continue as our we also acquisition portfolio expertise. deals additional and evaluate affairs sales utilize to Rigel's REZLIDHIA in-licensing medical GAVRETO, and will and We acquisitions that and organizations to product

Our development continues with MDS. lower-risk in to RXXX progress pipeline

the our preliminary We year. Ib trial data to generate by expect of the Phase from end

We excited that. tremendously are also about

expanding additional forward have Anderson our MD of Cancer all the first collaborators our strategic trials with trial generate opportunities -- development additional strategic for in in with on data We olutasidenib our the enrollment to look with clinical to and activating our to evaluate patients products. We AML. collaborator, for olutasidenib other Center opened

key to strategy. Finally, financial corporate our discipline remains

our quarter financial advance This are now the enables the and our new in top our us to current questions. As your thank approaching expand second and breakeven. we your interest to and grows, and will reinvest programs portfolio. With to business, that, call pipeline pursue opportunities line I open our you we Operator? progress for in

you. question first Instructions] Yigal comes from Our Thank with [Operator Citi. Nochomovitz

just had I a few.

cohorts? X dose that those and for reasons levels IRAKX/X expand you there the escalation, those to emerging some a on new X dosing new led Could mentioned that and you added were twice daily dose you cohorts. bit the On data

for you sure expansion. mean, we be the I based to optimal potential to And Thanks combinations. really know, for preliminary the efficacy. that the want And as to for question. PK, evaluating all we're focus II it's determine dose be is Yes, -- safety, the study explore thoroughly we able Phase

So, daily and options in the once in dosing. our of -- twice terms of terms daily

you'll be the end the year. of the So, hopefully seeing at data

And featured azacitidine, through Anderson, there the was noticed then years at that actually several MD for ivodesinib, investigator-sponsored was which I ASCO and XX% rate. with study around collaboration, ago showed MD an venetoclax Anderson also response

Just just to competitive goal combination study, triple relapsed/refractory in is what get you curious, be with diagnosed the speaking, once newly what in far? broadly with both this and to the terms this see want of you that

a Yes. Again, the selected thanks has size inhibitor you are and as HX for different different the also properties Olutasidenib know, combinations. olutasidenib ivodesinib that and different question. Well, potentially is by binding than ivodesinib.

that own encouraged But [ in we by in before. presented higher we're right. some our the of HEME-XXX the have been And evaluating study. seen also I data preliminary populations its potentially in it so have mean, efficacy we're ] patient

also to So, an also evaluate in like olutasidenib and to continue decitabine regimen. oral particularly we'd potentially setting with the

therapy, would nice which for eligible be have to something mentioned, a these triplet are oral particularly that lead for really for nice therapies. elderly As to that novel intensive I not could patients

coming for where point great, getting And commercial and the then guidance have just revenue sort in to be portfolio, that company you'd one fairly you're picture. providing years? a are point where with a established now comfortable commercial breakeven, a to is there there you start -- the more just is on you I'm [indiscernible] planning curious, of would which feel some the you is

breakeven future, a in product the think basis couple certainly the you think to the we I can't hope we a continue it. to a terms us forecast where mentioned see cash new particular, new to highlight business, you regular Thanks to so. that And it. to investor our tremendously. allows distant Again, a breakeven REZLIDHIA of and really future, be us in doing generate that. solidifying. is is launches, that net like And great for cash in future, base I additions the to where share question. we're to, financial future. is RXXX, evaluate for really with specific those. the additional really of and in or on I thing that in It reaching close I in and we'll trials important deploy do there of and income that see is But timing to One guidance giving for to and point difficult is more contributed something great business that achievement little a The That's at clinical so we're the the but generating oluta that GAVRETO business. we'd opportunities the not it's we

next Kluska from with our comes question And Cantor. Kristen

on here. great quarter Congrats a

to to for So patient of TAVALISSE, growth attribute you starts. quarter-over-quarter, continue new the some

So, give others? drivers treating are as aren't it what responding earlier a some key new are starts? patients they well? treatments? of mix usage to physicians can And patient these patients the for us prescribing to Are you getting that seeing in TAVALISSE sense that comfortable other Is line you

would it? Dave, you tackle

question. thanks for the Sure. Kristen,

you quarter, on what is slides quarter, that focused I the about you and patient our new look didn't starts showed on. increasing, clearly, give quarterly numbers, from basis, last As but a and the that if talked we we're at -- last I were

In are look secondly, at if depth think yet, other business, the on both prescribers. these our prescribers. getting patients. of TAVALISSE within focused years, we're growing folks And who still, all our breadth tried our you then We CITP And I both. haven't after words,

getting of earlier therapy, in make our pretty line second that starts. And we patient significant question, shared number of -- how new terms a in about part we're ROC data, of up prescribers your of quarters I of patients. line more ago couple our a the New still

We are good very there, look It's of subset continue it out earlier but look at patients. to a continues patients to that. that for live

the keep what continue these to you've in. in last I here seen after COVID for and patients So, seeing carryover of of coming the doing. years. And focused think And you're we've both I going can our is after quarter This And tell you month we're month, growth, sales things, our I now growing. frame. keep new keeps been especially on, something what time during X post that's quarter think that's Their been couple coming is years. particularly when

what you're built And new expect But think balance all with balance there? Should or to Blueprint X with should that financial more give and how strategy? sparing generate and a indications on the force are to back time you then to you've sales more potential how deals and the work clearly to really we we similar Forma did sales initially about going sheet discipline drugs. you

that of they organization, incremental appreciate And really sales, Thank but because is These sales the current value contributed our a of the the terms effect in you, tremendously tremendous to cost portfolio. products to good of I they Kris. and leverage post provide is portfolio question. line a fully does down drop X product the the in the existing they impact importantly, And once our financial bottom goods their launched. that's have deal have.

other be what can to deal the capabilities be time capabilities our So, where that's we than market a these ], for we look add because will that to constantly products. most current frames leverages say we're use focused be we that available may our that's like later. lot we value, bring It where And I onto think hemeoc evaluating are out products will in in to going value X get is to we product that and will give you can't near a be term specific the and will it there to forward. I product a a what continue on. [ deals it additional do

So, be REZLIDHIA or indications other tremendous as longer longer, additional we the have RXXX in other same AML, think will do term to provide trials organization MDS areas. sell they areas. to in other Incremental in opportunity. and We hope for I that growth the

Raul, I segments. we've just might time, efforts add both that through this focused and Institutional the Community in also

different had think product. got I teams point we've X ago, are months there. So, good want XX out to your we product, because questions X really we Kristen. had XX just But one, I months out ago,

think mean, we here X months last about we And of all X.X just And in very really managing this the June last in is product. X than ago. that years, less months, strong great different for these X learned and they and sales our use about had months. what a over third so And with X, think learned couple the in I booking we've we are portfolio. a to of lot products I a we've put transition

So, I think is talk here want matured solidified about ability team's our really to to execute team -- really, time. really I what just over priorities our on different has and

that can on. will our that's complex product bring we even so more that in And why team execute portfolio we a confidence have

next Instructions] Haque Jefferies. from Farzin question [Operator Our with comes

the a East on storm There's Coast.

Joe to comes the H.C. with And We'll Pantginis move from next next Wainwright. our on question. question

coming right Yes, now. hard real down it's

ask on So, some I the that want news to olutasidenib. breaking and about impact

vorasidenib So, FDA today, before glioma. the approved market the for close

potential ask study So, to regard wanted potential as with your the differentiation. well to as on plans impact I

Sure. Dave to comment and question. I'll ask maybe that Lisa on

for the Joe. Yes. question, Thanks

in a have So with inhibitor. you surgery. very They've only IDHX/X yes, patients as it currently glioma in vorasidenib, dual treatment. early vorasidenib, Grade as approved got received as We, patients that it's X you in mentioned, know, positioned

through CONNECT, our have are the setting global It's following already in positioned to -- with collaboration our now. be a ongoing study We with been going maintenance radiotherapy. we

patients a a line receive at year, vorasidenib. later we're year later, aside have with And the potentially going to at than and that, in they're a olutasidenib bit from second -- radiation surgery, combination a So, looking and looking then settings, other endpoint. then in PFS for would received also primary temozolomide potential

really valuation. interfered it perspective, our hasn't our from So with

Yes. would And just say... I

ahead, go sorry. Yes,

X And these is in tumors. really about mutations for when why gliomas, inhibitors why are key patients vorasidenib's that Grade in exactly work you have I really I mean, we're to think excited us. changed proof key that's proves treat would that. IDH a look Organization Joe, at this in Health approval olutasidenib gliomas I to X great Grade just principle to portfolio. our and are and IDH in data and that IDH And the vorasidenib's very difficult to and say, World is it role this are plays that

I say, And explore needless I we further, and Joe, that And exploring. molecule are that for to we molecule think think we're approval we'll highlight differences label that there's I opportunities -- as there between think beyond and you. that vorasidenib obviously our the

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

their like closing, to as our like thank to we Well, us have I'd better counts call for for you our this Rigel thank day thank progress. to every single In and you, and well. as everyone. in day, joining their patients on I'd lives employees And your continued interest to continued improving single and for of lives as the every make commitment always,

day, So, look calls. Have and on future other thank updating we you that, forward a to our everyone. progress for great you on

This concludes teleconference. today's

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