RIGL - Earnings call transcript Q2 2021 | Rigel Pharmaceuticals, Inc.

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Operator

Greetings, and welcome to the Rigel Pharmaceuticals’ Financial Conference Call for the Second Quarter of 2021. At this time, all participants are in a listen-only mode. 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, Dolly Vance, who is Rigel’s Executive Vice President, Corporate Affairs and General Counsel. Ms. you, Thank Vance.

begin. You may

Dolly Vance

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

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

Raul Rodriguez

and on CFO. for Santos, joining us Dave our everyone, Thank Commercial Medical me Dummer, you, our Wolfgang our quarter Chief you, are Chief XXXX our Schorno, Dolly, and , call. Officer; today joining second conference Also thank Dean Officer;

beginning slide Now on five.

across this continued our to the as value of During all page. you key see quarter, make good drivers, Rigel progress on second

ITP, real substantial as last of our XX% also increasing sales to growth in in headwinds In with very potential in improvement subside, our pandemic customers anemia, during or describe and progress had pandemic as a and heme the near very remain will sales the net well net very warm a trend opportunity year, of increase to QX our relative how to We'll call. term. to for detail. to we're will and our address we the this good in address the ITP discuss prepare some began Dave We Hem-onc sales. over more opportunity Dave and While better AIHA. Dean in made the warm autoimmune size force AIHA. hemolytic of the describe important

eight three to XX us be significant We treatment our our the targeted added market months. patients of in the capture with AIHA have for substantial We enrollment a the XX potential enrolled last progress This this product first approved now share opportunity. goal patients of warm puts the this to trial. in of to closer

with which made our from therapy excellent COVID also needed have in conducted QX, fostamatinib, We results with Phase trial COVID line patients. the progress results will and and exciting for awaiting May, impactful COVID are their trials. late Inova. our clinical provide Wolfgang the In of a filed overview and update decision. with hospitalized potential program a has we to an collaboration these with provide positive in brief potentially clinical top FDA U.S. much EUA reported II our on the NIH other In still we

with just in nearly enrolled patients, half and quickly, the XX Our enrolling very patients the trial last months. two targeted hospitalized XXX reaching XXX patients own III over has Phase COVID in patients,

our With and patients program, included we with the penetrant and have preclinical as the studies ALS. COVID-XX indications quarter our RIPX We RXXX molecule, Lilly a and have had with a ACTIV-X in [ph] all, such which see study And has CNS look forward drivers. are RXXX is our On enrolled. with we're We has two systemic we NIH-sponsored molecule. our incorporated entering IRAKX/X of We MDS forward to with this earlier partner, our tissue efforts on are Phase delighted have I/II II in to with also moving inhibitor in received value very programs, RXXX study prodrug be already starting feedback which our of In a first program, protocol. Phase low-risk advancing and study and potential hospitalized study good patient all across our clinical our molecule. in into we that Alzheimer's our host it our working is key a on FDA

patients in of areas, the some of these the committed COVID and need are you. opportunity in then the is Dean's and Dave, progress we commercial update. year. the Today, clinicians who and substantial a can financial we treating will clinical well. by through as hope the Dave's then and subside to are to expansion, what discussion suffering them some who during COVID to with The our start Wolfgang's navigating still update we we'll on programs on we're half our remains, are followed headwinds While second address

Dave Santos

another to this be and all happy greater I'm members our and And commercial will attend we're with our team, today Thank on with summer time in impact able the meeting. That sales make one terrific being customers even our depth our afternoon. line and to of of I on continues, from and theme that I good I'm to highly as as has their field report afternoon It be you, spend person say to to they're a patients. road the return able [ph] my customers' quite their can an talented Raul.. together been the enthused about presentation

and am who to treatment. thrombocytopenia, had growth thank move team our would to our in chronic previous slide throughout cITP, have for on expanding you insufficient with entire I our Before see hard where work or that to response is begin, quarter FDA-approved seven, to I return of patients the continue will commercial now to the like for like to an indication QX. with would adult immune proud a their impact TAVALISSE. I I commitment very

year. increase million, the same Moving over net quarter product eight. slide XX% of to produced last We sales QX a $XX.X

We also of date achieved bottles. X,XXX highest quarterly volume to our

as to our the volume was While that quarter positive The we to progressed. graph bottle distributors the trends some volume year quarterly XXXX, patients bottles and to shipped to in a left XXXX and shipped levels compare our since bottles return very in were our you to on clinics depicts see can demand QX, patients and during normal of inventory XXXX. happy last so clinics

QX, QX growth and patients sequential X% versus QX compared delivered of over XX% quarter in You grown XXXX. and has will the growth to our see year-over-year demand every clinics from year. that In prior we

clinics and We this continue our we upward momentum increase are in slide with and depicted can reopen very engagements in-person in encouraged customers. demand, will is why nine. grow by as we And that to it believe believe

of bars the side, the see sales represent through interactions. progression interactions first our you the left virtual interactions the will the orange of bars On are and The quarters in-person our two force year. blue this

nearly driver We grown to increase have interactions in-person compared overall year. this where biggest this QX throughout in in And QX. the we number tripled for interactions the is significantly the

blue in interactions were dark of has since as from see grown fact, it the And of that was In in-person. significantly QX, can our our to in-person line, QX. see you percentage great calls half

seeing our we any significant accelerated have in-person virtual without reduction interactions Importantly, in interactions. significantly

every job to and a customers. live doing where calls, is great team see they their make Our live hold available leveraging attend speaker sales conferences opportunity in-person can programs

research, for the the physicians able by many with that continue pandemic, on made on TAVALISSE. force we not demand to more get person. allowing to have size, clinicians for hoped shown see messages accelerate as expand TAVALISSE of top opportunities size we for to. of and We're All To XX more build to who strategic the resulting start sales particularly Through for QX the treat We they ITP our reach will respond the them these ready prescribers, caused giving broader XX% XX, a majority call prescribers as efficacy reach and force were the stronger travel commercial in us of as our believe interactions had to clinicians see to the previous organization mind to extend we XX to and positively as market awareness awareness, we when have But therapies we expanding TAVALISSE. in or and as with see our among of to developed slide and ITP. more reduce trend our we decision clinicians reach sales their are to capacity improve the territories, customers time among as constraints to our to on expansion they're this from customers switch well team, frequently. and them contributing patient, to call on significantly

of new that the expect You bottom already members, progress end next recruiting we've wanted sales for made lines. to hiring will slide force will strong spread see XX, particularly tools on the in highlight our to efficacy And slide territories and in that our our team by month. all be operational the earlier I lastly, we have on we outstanding this of message, and

promoting may our you response left, actively highlighting lines. have rates recall, in and earlier the been post-hoc on First, analysis we as high

teams that our this expect of calls memorability increase. data make in-person, will to as and We awareness our more the - continue

that our well messaging data implementing five be on meaningful effective showing increases over will we are highly importantly, durable and Secondly, researched time. and platelet year based

nicely clinical over messaging see efficacy move new fall quarter demand sales TAVALISSE, customers messages. In was talented patients patients increase to your XX,XXX for counts now and messages with into as In even with are the clinicians poised turn TAVALISSE efficacy Wolfgang? By believe higher, final some and over time platelet and accelerate augment more and are Thanks years. and our with seeing we to Wolfgang. this more of will experienced beyond and or expansion sustained call We efficacy we year. will equipping we existing look seen this we more fact, our attention, members, I for on and team XX% benefit for on growth forward four more to implementing powerful with TAVALISSE. our the respond the of patients the seeing them well compelling of to as summary,

Wolfgang Dummer

Dave. you, Thank

we Despite anemia. a our disruption to you due patients to with update gives ongoing into XX start COVID-XX, autoimmune warm me hemolytic Slide continue the randomize study. continued brief Let Phase trial. steadily III some on

As today, as of those XX reached of XX study those approximately XX Raul well. over our target have the majority vast as and of already have weeks, into we patients randomized rolled XX. extension of of the patients mentioned, have

first are the the medical be unmet significant data need we well are designation. in to no we advanced in market indication. is the is FDA of the upcoming With reminder, and to approval, drug has orphan III As remains Phase as looking forward Fostamatinib development readout. would pivotal opportunity fostamatinib a of FDA XX-week a therapies final enrollment, track, fast large. as in stages near stages this and And as the

switch data, COVID-XX. into a a treatment external a May, compelling gears has started University the and Based our an now to outcome We've fostamatinib, that raised take you program Let's year II research institutions, clinical which COVID-XX the positive with as have from late shared beneficial that fostamatinib explore authorization College fostamatinib as fostamatinib by experimental XX. to of the as from April. of to over patients. strong MIT of review. NIH-sponsored currently in use A external in Imperial NIH, London potential began ago, emergency on might Phase That filed we the such for under little COVID disease. is and well the Harvard, interest the slide provide for as with we be Amsterdam NHLBI COVID-XX evidence for It which

progressing as sponsored fostamatinib that has large We a on data Phase one in III NIH top also is And on update which on that, ACTIV-X patients. provide study have a arm of to severe later. well. hospitalized randomized ongoing, Phase the in An Rigel additional III called trial chosen fostamatinib

used with population of The scale, disease program. COVID-XX for all widely we'll X Phase and vaccination Tissue patient interest see Phase special presumably the patients. range, most a the with patients newly covers London and are mild of covered various ordinal if shows the a The there X investigate the these Imperial NIH improve X-point you As Host new include prevent X-rating initiated The is patients hospitalized in included College study clinical patients severe evolving treat. plateauing, for milder with remains our III variants to study of fostamatinib options can That our with trial need are to patients scores progression the in we clear and recent rates population. patient data disease. from clinical ACTIV-X XX hardest treat outcomes Slide because which will patients. X, virus the to and III can X X, or similar on severe

in trials populations. these evaluating clinical COVID-XX patient a are So wide of fostamatinib range

as of completed measured of remember remdesivir. of Let was in of XX. by fostamatinib that me serious standard The primary such remind the appreciate is care from versus takeaways to NIH randomized the XX The you it outcome, dexamethasone need standard the fully of the X:X study on was, top events. To Phase you enrolled study add adverse end to slide of and II plus question standard recently safe the as fostamatinib study incidence first care, primary care. the to point on patients plus placebo safety key

safety serious similar, favorable which both and be the the same groups profile, was met would in the hypothesis rate would that - safety AEs goals the already. of or fostamatinib's about have Given

the SAEs the However, half be fostamatinib to of cut out incidence in compared turned alone. care standard in of to group

on placebo which South deaths alone in more Rigel-led Given protein, severe patients, were occurred continues clothing all noting label the to three relevant is U.S. in SAEs deceased, see care be the COVID-XX. needs two group. also disease. these quite multiple are who and well patients fostamatinib we in once also and efficacy to number If remarkable. And improvements of potential Ferritin on both a be the such extubated safety end approximately I an where effects consistent improvement are that ACTIV-X And addition improved trial you this quite death, were mechanically improvement hospitalized were to who remdesivir you America, patients is could each XX worth D-Dimer. positive, intensive group days risk secondary enrollment XX, We with outcome the there unit. with sites enrolled. We The NETosis, no big basis clinical ventilation. blood to intubated can biomarkers, On see treat the year. all ordinary this study. four over can in be And on standard The and is in mechanical were in findings in in or our such factors disease objective COVID-XX inflammation you is develop in these for conducted measures C-reactive the while with finally, survived. indicate XXX group. and mild trial. for at ventilated. given certain Phase to points extension as study. arm, study have dexamethasone, standard days which said, complete this as three intubated the is of beautiful hypoxemia the study currently There group in slid patients. before as other the for as two There study expect were be includes that two the The to to more lab good the It COVID-relevant as ventilation The patients entered likelihood in fostamatinib of the in On detail could a and as is deaths of of of III of the slide There accepted they study And patients I enrolling surrogate fostamatinib That group, and trial. events, have fostamatinib the end XX, now, overview issue. NIH the on efficacy. remarkable in rapidly. in see care already of COVID that patients All in the oxygen, several patient the consistently scale, are the tell favoring well high were care

COVID-XX. is and hospitalized NIH to announced showed Phase for is designed each The study. earlier, to recruiting patients II that we late in be is The and trial selected pre-planned the at will in for patients. The flexible patients you including adding will based similar enroll and each with different was study As population on the four in approximately utility fostamatinib fostamatinib treatments, allow I arm. protocol evaluating patient June, The be to new run of analysis therapies more than XX currently arm. XXX in master sites stopping is trial

The first the NIH patient treated was by July announced on XX.

the dermal. awaiting to in submitted submitted on the a decision study data II have having with May, summary, Phase from and NIH we So slide are peer-reviewed FDA. XX, EUA Rigel an in a late been we completed

studies patients has And Our has of II study generate in enrolled and has continues valuable acute The will XXX to other and is tissue already investigator-sponsored Medicine is about host a lot XXX NIH respiratory far. influenza enroll College started or study ongoing These Phase more fostamatinib the syndromes. patients patients. over incredibly III which study Phase enrolled patients to so recruiting London and distress data, date. will ACTIV-X non-COVID-related Imperial exploring be for

of pipeline selective to suppression a promising showed So X MDS. more slide let's of of pathways inflammation-driven targets in now like our is turn which X, RXXX XX. low-risk and information IRAKX/X study Hem/Onc well preclinical certain conditions IRAKX complete IRAKX IRAKX as inhibitor The inhibitor in and both auto-immune and compared dual only. a are diseases, to programs, RIPX, as

the inhibition treatment pathways With marrow marrow previously, the cytopenia. bone of in IRAKX/X PK we discussed initial and ideal or a profile created volunteers. ascending leads XX. improve order levels, of to challenge and healthy exposure. with LPS-induced generated LPS proportional which of was targets risk data As well oral proof-of-concept and profound TAVALISSE and IL-X, low linear Slide our Moreover, to an in caused expertise RXXX information have dose the and is XX. cytokine multiple had bone for There a as and RXXX, single-ascending we utilized pro-drug MDS, such previous deficiency or we exposure bioavailability inflammatory dose TNF believe by post in called RXXX. alpha was IL-X. tolerated production, that In with clinical Slide RXXX human study

dose We dose the have molecule. now completed with multiple and new studies single Phase I ascending ascending

the healthy XXX data presented a exposure to good well pre-IND plasma I safety the tolerated design low-risk and levels proposed were comparable RXXX. results expected, target our our I study Phase feedback As to We with for in was PK/PD, drug in Phase results and package our on and FDA received MDS. volunteers the

what's clinical the our low-risk feedback to So next, with clinic are this incorporating into we plan into FDA move MDS. program development and study Phase I/II the in

in Additionally, as or hidradentis such suppurativa continuing we are area Palmoplantar the explore others. immune indications to disease, pastinosis, and

very with IRAK. we excited So our about progress XX. are Slide

our cultures generated We on and collaboration to leaders recognized Dr. animal RXXX with to for Anderson, program. slide Guillermo forward translational is add as research leukemia. Anderson to excited in RXXX the working at well. We're will hematologic MD also are team be Garcia-Manero's Research MD in update of as with myelomonocytic they of chronic clinical to in goal body we opportunities new MDS to look a the date you conclude to I'll models wanted cell research for exploring Institute Cancer evaluate very IRAK data the XX. with research. collaborations further with And cancer and

is partnered we value with RIPX have very that program our driver Lilly. for Rigel Another inhibitor important

working is with closely RXXX, study on an candidate, autoimmune the inflammatory first conditions. Lilly indication. systemic first planning RIPX Phase for oral II for We're in The inhibitor

penetrating the ideal for We're clinical In with With diseases. brain can selecting therapies blood finance I'd is numerous Dean [ph] CNS update. of in odd huge a developing lead And inhibitor like then we have in to and expertise will Lilly excited inhibitors RIPX the for to autoimmune very for indications. potential the working addition Dean? brain RIPX candidate Lilly their about inhibitors partner broad to diseases. here the that the CNS that, barrier. turn RIPX a in cross development at on are Rigel,

Dean Schorno

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

remained quarter of shipped gross to the For increase in $XX.X at those net sales. bottles our million, X,XXX patients of product compared a the $XX.X shipped and our quarter of quarter product bottles second of while resulting second in to to of million X,XXX reported XXX end clinics, the XXXX. distribution XXXX, of distributors, from XX% we were bottles channels the We sales TAVALISSE specialty

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

Our of product gross-to-net gross adjustment XX.X% approximately sales. was

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

quarter we our quarter, and what completed expect sales growth continued Once second see of force shipped towards the and in bottles saw is to third the to quarter. we expect expansion We physicians clinics, patients third assuming of to similar and see in the end the in expand, the or expect continues currently XX% of patients be approximately XXXX. gross-to-net adjustment to that to quarter. XX% we third the sales acceleration to to access in our in an quarter fourth Incrementally,

Moving to on the next slide.

our Department In million Rigel's addition our Lilly for sales, million from were revenues contract pursuant certain fostamatinib from of revenues ongoing collaboration of pursuant services with $X.X which with to revenues related and months agreement related Grifols. Phase performance with license we deferred to three contract III our the the of XX, our to $X.X recognized in recognized the agreement U.S. to Defense collaborations of income from COVID-XX. to consisted $X.X Government for product of trial $XXX,XXX and net ended research was clinical million revenues of XXXX, June our development

and costs to expenses. on Moving

related costs our The second primarily studies. costs increase net for of XXXX. in to quarter versus $XX.X ongoing was costs, to stock-based of in second $XXX,XXX due the in and Our clinical research XXXX $XX.X increases approximately and product million in the expense cost XXXX. the sales costs personnel-related compensation expenses of was and quarter Total various were of quarter million second development

and certain the expect for the costs of remainder we preparations potential expenses and sales for Given our total EUA, expansion year to force increase.

a potential appropriate the As EUA of approval, we clarity provide gain updates. on timing we'll

of $XXX.X like million. over I'd with back quarter Raul. investments turn short-term Finally, the cash to With equivalents and Raul? cash, we to that, call ended the

Raul Rodriguez

the and clinical decision this indication, there Phase the provide clinics and enrolling Currently, earlier-line the open in potential expanded Thank to care pointed am therapies. very towards getting to we half year, to on address as mentioned, opportunity giving forward EUA I some as III working In complications interaction of look meaningfully more to our are out, our new no keeping of sales We use of educate with opportunity about proud we our the have In therapies new exciting as the help trial Dean. in last some the application from we're Dave of Phase the quarter, and fostamatinib completing Rigel is which, on the of and we this accelerating year. we that later to make to look prescribers to most In to important market the complete provide has enrollment second ITP, the a of team, disease, and interactions our Fostamatinib patients top III AIHA. suffering this you, the reaching in-person These our we durability milestones a therapy AIHA, the progress trial, patients as of TAVALISSE mind expect clinicians clinical damaging decisions for starting patients. products, enrollment potential in COVID-XX, in has a warm approved our this space. leader rapidly. are rare to on disease. forward first in and improve close. for to be

to and working to bring our very patients. diligently are date are encouraged by this We results to therapy

of we development Phase look In our are RIPX we train for into stage our II the supporting addition in our and our with select trials, IRAKX/X or potential Lilly penetrating programs the forward RXXX to to TAVALISSE earlier indications. the of RIPX. excited programs, as We we program CNS about advance fostamatinib, and candidate

and IRAKX we wholly these trials in Hem/Onc tremendous are potential on planning MDS. low-risk the Our and has molecule, RXXX, currently first of autoimmune diseases, owned in

call open exciting your numerous in questions. that, very to have including the With up to, near to let's look forward the future. We some milestones

Operator

first Thank Yigal you. is with Instructions] Please [Operator from Citigroup. Our Nochomovitz question today question. of your proceed

Yigal Nochomovitz

been based taking the you for Phase FDA I'm figures XXX for the Thank the data discussions as EUAs XX-patient enrollment favorable III on has III Raul, your trial, mRNA less vaccine. in the questions. receptivity that the II than EUA patients. and Phase those supported team. well curious enrolling magnitude for great. Hi, Hi that's very several And trials what the the much Obviously, the as to are orders ongoing of the enrollment Phase

So just curious how Thank that you're thinking discrepancy. you. about

Raul Rodriguez

Yes. let expectations. And FDA I'll Wolfgang that. comment after commentary some on add color I'll Wolfgang? reaction also

Wolfgang Dummer

Yeah.

So interesting question.

very getting worked welcome They is submit to how EUA. inquired them. FDA sense I thinking not it have whether and makes closely so exactly with tell because EUA. We the FDA we're did an you constant did that, updates cannot we currently submit the from the

drugs So had sizes. I opinion. can only EUA-approved much other larger sample give you my personal And you correct, are

placebo-controlled. compounds with efficacy you small double-blind very the very So as And XX our if standpoint is but effective and as look data relatively from favorable. some in clinical And the fostamatinib this and does very, at But some it's look well point. favorable. compare remain issue essence, safety, [ph] a approved of patients, set your homework the strong and data and end look effect EUA an of question sizes review do very with at your the points

Raul Rodriguez

larger mind emergency use not-too-distant your comes in data forward, that and Keep future. the in be that, until coming the intended is Okay… to own temporary EUA and an is

certainly, get get for we'll review. or but still no a it So yet, I it's is think this by yes type we'll mean of a the being Again, reviewed as EUA a doesn't appropriate FDA.

Yigal Nochomovitz

of I the X-point X on X in scale. I points had X trial. X eligibility But a a your the eligibility and a shifted, question. did MATIS for housekeeping on just housekeeping got -f ordinal that – Okay. the Thanks, scale. spanning not? had the it - I Raul. trial in points throw ICL/MATIS had regarding another I Phase And bit II just I if question, noticed housekeeping that in I a trial shows then think of just that X-point and slides, that was a ordinal That could prior bit today's slides,

criteria a one? So am this there change enrollment correct? I in the Was for

Raul Rodriguez

I'll that, the ahead, Go I let clear. think Wolfgang? Wolfgang answer but answer is

Wolfgang Dummer

shifted slightly of very, scale there five, we criteria change was they're scale bit enrollment on equivalent scale. sharp they no of a it's odd slightly a the to it's effect Yeah, but a to an has simply a of using. different different College uses But now that it's because use in Imperial just of little observation. very due that are London same. think used No, And it But one. the the the

Raul Rodriguez

this an is accurate So representation.

Yigal Nochomovitz

last Okay. then do a IRAKX/X. versus behind need not? I you. just thinking is to RXXX of the the Got the prodrug formulation question on Thank the it. And What had

Raul Rodriguez

Wolfgang? Sure.

Wolfgang Dummer

Yeah.

as is of in data that XXX, volunteers. which healthy great in XXX human has shown out which as release know, with results as you the XXX, variability of with lot we've molecule. and turns experiments I bioavailability done Phase is We So well cliff a had you and patients. [ph] less then preclinical XXX But with better much a it

administer is a it's but patient - the XXX. still clearly metabolite better compound much XXX the to it's to So active

administration with advantage the relevant. it's all data So drug XXX still for that a XXX. we generated are have But

Raul Rodriguez

proceed FDA to on - with to And XXX. hear the an low-risk us the we And were they also that the light study this were agreement waiting green from giving XXX. with MDS

Yigal Nochomovitz

Got whole team. it, the Raul Thank and you,

Raul Rodriguez

Yigal. you, Thank

Operator

proceed Piper The Sandler. next question. Please your with is from Chris Raymond question with

Nicole Gabreski

And Chris. Gabreski I Congrats thanks taking for one Nicole is on on the TAVALISSE. quarter. This Hi. guess the on question. maybe for

still early year, I commercial starting into now on guess is Or more for COVID take account hear expectations the potential does Delta the of surging. it impacts? headwinds with potential remainder to about growth throughout your that TAVALISSE too front? we're any So the that variant

Raul Rodriguez

I'll were Hi, before COVID out. of We do this believe what had XXXX. standpoint our storm comment people compare to And a you, are variant, been Dave. to to was Nicole, can't down vaccinations continuing through when the at variant XXXX, is where Dave anywhere, very of as aren't out worse very been of than difficult locked know. forward, When down, you a ability but locked you Thank From affecting on moving where, Nicole. in particularly to things now, it there. very it think any get were ask and that. we get it yes, are least the that you things Delta we've kind have rough kind Delta - of I go

a hybrid there speaker more in-person point, this calls a we of so as if of We sales programs, be, planning think the both ASH, be well. at our least is impactful But that. out we interactions. do I for in of much we increase ASH this It by any seeing way, particular, in and kind make model. us how at did quarter TAVALISSE. calls the December and up. obviously, which in prepared live level able But year people more conference to of marker is for an at unknown a And that, conferences. to that want is have were even terms will part the will for open we to great last ahead in And noise see still, think opportunity a And lot with everything there is

hope that I helps. So

Nicole Gabreski

guess just... Yes, then I helpful. Yes. And maybe definitely that's

Raul Rodriguez

other The the I our one we've we're the on expansion as who've way or folks already that folks thing. I of offers. expansion this we are actually with accepted bringing hired have already in you, told because on

calling ending usually on, were previous previous an to customers XX, at in they to geographies is with than of either they in of us of We have used a help I their going previous more or size than when to our to bigger virtually their have oncology sales lot Hem/Onc you company. force an which average roles And seeing in think years brought live. used XX we on or clinicians experience, they people remember up

see to even this able, really new people customers really with said, them more more helps as I hopefully to be and So us in. customers those be coming familiar with see frequently, and the

Nicole Gabreski

be guess COVID Just especially just that the for strains? maybe very COVID viral if of in helpful. I being on becoming kind be screened I dominant. And treatment you. now ask Thank second quick response with differences Delta wanted That's I'm might Okay. to patients then a any question dependent strains? if to just your could studies. there are ongoing fostamatinib And variant curious on just

be thoughts would So color here any great. or

Raul Rodriguez

comment on that. you if Wolfgang, Sure. would

Wolfgang Dummer

as action this be dealing in be But we other in the independent And answer COVID-XX of to with well, damage. The variant no. be and kind organ fostamatinib screening get those to to Yeah. problems leads independent continues and tendency on of as distress There vessels, mechanism blood of in as the because time. failure what which optimistic to the variant I is at is vessels, for for inhibited with. the the is respiratory no a should would fostamatinib strain the pathophysiology well clothing in larger that respiratory smaller are patient renal this as

Nicole Gabreski

Also very very helpful. Okay. much. Thank you

Raul Rodriguez

Nicole. you, Thank

Operator

from Mattan is your BMO with question. The Please Capital next question Markets. of proceed Gary

Gary Mattan

[indiscernible] is in Thanks taking filling for Gary my This question. Mattan. for Hi.

So terms the or authorities in first COVID-XX. of do progress in Delta how hospitalizations ex-U.S. discussions And TAVALISSE opportunity secondly, been now, with more any regulatory potential especially from COVID? Thanks. variant? question you for partners there view my increase for in Has with the with

Raul Rodriguez

at of Wolfgang, you stab latter. opportunity a the as the take take Outside I'll the Maybe U.S., may the first those. imagine. substantial, is you

we're other in think opportunity a would where quickly move been We've in as - fortunately, authorities in those the well-known it U.S., but and more product. focus, the a the and to is certainly and The entity first with product U.S. to we're territories database with partners rather move been are the countries. with exist, safety provide been have discussing well that's regulatory forward our relative because on other them, we simply market. our our advanced U.S. here, the we've And here we significant main I the

the is the it in first us. priority So COVID… for Wolfgang,

Wolfgang Dummer

Yeah.

hospitalizations. around Yes, was depending a second you Your maybe it. numbers increasing of at how thought indeed, concern We the down. there on part look that was was go concern question the case

out that. very where very rates, the quite which is cases this variant, stick variant the is It certainty to going And go that for vaccination turns small other up. have turns I a States firmly what certain believe the of is that it the areas around predict while nobody contagious. issue Delta - rates. and after areas can comes United is with Now continue out in to very a vaccination continuing high while we have only have the new

We America. have South variant already heard Lambda about in the

for So we that they we something able I have need vaccinated and believe and but going we disease are the to still provide hope Even And that. vaccinations sick, there is treats some continued now, a though effectively. - to have we're not get treatment. need be a lot people of

Gary Mattan

color. the for Thanks

Wolfgang Dummer

you. Thank

Operator

your Jefferies. Eun Please question with The from next of question. is proceed Yang

Unidentified Analyst

the is enrollment This Eun. Hi. around I completion assume patients two, on around for of be to X reasonable for rates one, have it Nalin 'XX enrollment per by would X based please. Number recent most wAIHA, to XQ month? mid

Raul Rodriguez

to stab X we have a in a X I had past, can is to to COVID really driven. And mainly of It's more you where X month on that. take we've months a than hard the months at And month. X where less it things, and project. a than lot had dependent

have we the we And sites higher later now enroll. And hard are The the that Europe, there's in and following. Many in it's Europe. in is this in so sites think to mind U.S. the will we than our the answer. a it note do in preponderance I sites, U.S. have when year European. But of exactly rates vaccination project Keep

confident that, help and there patients in doctors out seeing that going frequently. their recruitment, terms of So will of we're in more terms

months, only just it's to the not in we not-too-distant go. know It's patients have hard to do that XX but while many. We it's So approximately exactly more predict future. the

Unidentified Analyst

it. X XX% looks data took it more second months you. patients. you readout III the before time 'XX? could for year-end Got COVID-XX, about Thank question, of line and the please a enroll defined provide for Phase for It like to

So enrollment. expecting accelerated we're probably

have the activated percent many been how far? so So sites of

Raul Rodriguez

COVID enrolled quickly. very X the we've enrolled side, actually we've on X.X think day. patients. XX the patients months, about last Think a It's In I Yeah.

And as helped And so the. and is may a though, we've America, there's of US started. But as raging in real tremendously been for we has to pandemic patients started terms know, countries, enrollment contributing sites slowly acceleration, Latin when unfortunately, well. Argentina. gone the we those, them. to those you Brazil It initially particularly in as

and this expect earlier to have again, And trajectory And the of is, in calendar that think of very continue XXX AIHA. it's particular. And in year. rate patients as so months, we reverse the the But in XX certainly it's term. U.S., the brisk to pandemic completed not that in what of Wolfgang if Brazil we said, in short on we subsiding countries Exactly month we're difficult we say Argentina, because and anything, increasing enrollment, maintain the have enrollment of little in know go. said don't to bit kind the X in end the by will a of I to

some that. you So it gives estimate of

Unidentified Analyst

And ask it. may more I Got if please. one question,

results. those be South Are would And Thank affect of there lot the patients a you in care -- like the how looks from it standard So thinking how would are that different the may in America. come the about of U.S.? countries of you. from standards

Raul Rodriguez

products for pandemic, U.S. I'll the maybe, in outside well [PH] have let EUA which care, applied comment Wolfgang done in have you Wolfgang, comment, received applied are this trials but U.S. of other other that want I approvals will many make a primarily of -- say, America. standard do of - have I Latin But terms to of us. versus, think terms bodes comment,

Wolfgang Dummer

the But also that. dexamethasone, would our remdesivir, might for widely less I stratifying of which is the And say is know, only America is so use study. -- we're as not that available you South used we're in in used, and is as widely available cheap and Yes, there some where America. that world. in Latin Maybe everywhere be widely conducting

other in So data shouldn't one remdesivir modest patients stand-alone treatment remdesivir really to arm patients, going modest our and the arm. I best. be it in equal look all the are an there's percentages. No, hospitalized of at is the in the imbalance Also, we in arms are best. all have where effect remdesivir at at is if effect the you consider the - of

do patient. I a different believe remdesivir that patient not dramatically remdesivir not versus a getting is So really getting

potential little about So issue. I'm very concerned this

Unidentified Analyst

much. very you Thank

Wolfgang Dummer

you. Thank

Operator

with your proceed Fitzgerald. Please Kristen question. of question Cantor from is The next Kluska

Kristen Kluska

Good everyone. questions. for afternoon, the Thanks Hi. taking

is So on TAVALISSE. the first

therapy. at You've correlation in analysis post-hoc along over I side with the the you reduced collected some rates. nice of just then ISTH, a rescue also lessening effect line bleeding And about platelet outside had data of response lot also know earlier the and you've a data time. profile showed with events past, But counts

not I to usage, you do but you line this new conducted message you've in they'll collectively earlier reps that your this of along wanted some just this going since also help launched. is when new well. efforts, believe and going you be how to territories as with achieve So trial ask prolonged marketing work just the as new out more these the initially first with for versus time And and usage the sales especially about specifically of talk

Raul Rodriguez

use reps question. good That's Dave? you the today terms to in Absolutely. Kristen, introduce a terms what for in ask new as a for you. they're clinicians. one. to lead of comment outlined and going that very thinking And of thank to the that I'll on the he they item his various themselves Dave data as

Dave Santos

Yeah. Thanks question, for Kristen. the

exactly because our we well what great we've boards, we clinicians it in in expanding, both as advisory why think is research exactly as research. are in seen forums, in different I and it's to as one it's traditional more talk a market

make our message reach mechanism kind as you heard, as are as And do post-hoc since And the our has data beginning we'd a in - able platelets It XX,XXX said, on over our that that are reach either of line low so over many of surprised majority And rates durable and able safety platelet is what benefit now of really piece been that they stronger. cause while them clinically that out once durable - that efficacy. XXXX, because clinicians that goes think of it when not the are the meaningful it we is the the we level is efficacy really lines. have response meaningful. rates data, course, And patients - them ring like. then to add or time, And in for But things right add we've is on XX,XXX, you that getting appeal and XX% on patients efficacy of we're can of earlier does just we're hear you getting there to to clinically the true. level many how which over patients high of XX,XXX early kind of of really as that now to and benefit it different. they this focused analysis quite

lot publication in hear start BJH is And terms we a to out They really we're experience. strong effective. try And post that there over used The a been TAVALISSE. drug other get a this really and both ITP, and want patient of very steroids very well they drug in to doing safe, as using we're mean, these again and hear with they so what opportunity is and as safe they it in over of have areas switch. good when it about and X-year docs safety is tools. his they that efficacy analysis I have an it, a when or see they

their that it a responses it and drug is was just give. their to continue give they it's a And over at we today. patients, time. so just for build about them talking meeting a to platelet And counts durable watch funny, They easy I guess can it twice were day. have

think safety out message the benefit. efficacy get true everything it's will in out our we're speaker and to programs, analysis it's that to And there. message be the when that doing going on ring trained We're are kind line just to reps sales new they're the have area. our we've So we data. had what what the do. that's re-launching And going entire in before exactly be trained And this with of there. the durable we with X-year force to them going going And to early

Kristen Kluska

that says about I into Great. Thank that. it slide these Can And specifically, new quick some you criteria you. in little are territories. these? choosing And more talk follow-up a territories? smaller what went think of bit on the XX just the a

So positioning? about you how things competitive like thinking are

Dave Santos

of there territories territory cITP in in the as of XX the the the terms claims territory. in chose We No. are based well prescribers as on that opportunities number the

of XX, some just have the territories were that simply very to potential, before, that it's territory. we you our as much would difficult key of the territories was that existing the of of geographies. prescribers XX as it balanced many could. of it So That well the all best - mix to large frequency in the as a were we more across as And get prescribers. the But makes like on

geographies of we've And of reduced large the so this with what that we've force. I size these sales dramatically makes sense. done of pretty size increase hope the in is some

Kristen Kluska

your The is Yes. Pantginis from Thanks. of next proceed Please Appreciate question H.C. with Operator Joe that. question. Wainwright.

Joe Pantginis

Hey, questions two on one guess, then I afternoon. and logistical guys. I on quick, have ITP. Good COVID

I primary is to front, regarding curious and bit a you the look endpoint. a little scale, COVID guess I with of just or So and it on when ordinal was ACTIV-X a at just difference, different if the it's wording difference regard the

I So day has you by when ACTIV-X here, endpoint a slides oxygen was your you're X requiring survival if there. though and numbers it's the primary ventilation point like end really even says just XX, at of about without supplemental curious ACTIV-X in talk there's day the but differences. something where X covering between X XX,

Raul Rodriguez

Wolfgang, also Yes. would could you in. if take add I that.

Wolfgang Dummer

Yes.

other SB ordinal similar that. oxygen But are in ACTIV-X population certain failure are criteria. the patients like need It's that you of correct. and say not criteria, have I supplementation. and scale hospitalized they NIH, things identical the when because using like are So inclusion essence, is that isn't respiratory They these degree to

point, this To always one and they and appropriate by comments and have and others, similar. is not measurable, that's been your end in also therefore, regarding think meaningful. the as quite used reliably point that accurate. these NIH it But that your But is point has they're indeed, is sensitive studies So end is clinically are increasingly they used. oxygen selected been an is

Joe Pantginis

any regions regard patients. between of then can to - of And sort two approximate just South it's you it. said U.S. I enrolled Phase curious, the the America. with Got it. Got obviously, proportion and was your you provide III,

Wolfgang Dummer

majority South as incidence America, right share the sites disease now these simply to I can due coming just with The U.S. in Yes. do you of areas. from But our from well. is patients the we get

Joe Pantginis

to Got it's it. And it force to early my a might meeting. very it. as nice the this, well sales as ITP then little hear still ask question, about increased face-to-face Got but the expansion, be

I share So might that's too you the or ask, I hear. field data? to Do guess it the to or very feedback nurse to regard good or any receptivity now from nurse anecdotes would early. be earlier-stage again, to have practitioner physician with

Raul Rodriguez

take stab to at a Dave, do you want this.

Dave Santos

research really in data on It's of have to no as issue well. ready call, it. said and and Sure. when the just that in are - I what it's Docs going question talking mind and promotional talked of team, over a kind items And TAVALISSE that and a as and need some get out front that's this with able message over a present they or about. and see that's TAVALISSE when how when about see enthusiastic have about get at again, we of they there. the forums doing. really really last just in I to front they they there habit, they doc, that of to them, they're And through are patient Actually, issues the with you top I've we're am an we're switch, to start just the of it's here they of these because timely look were

steroids. switch just time, patients watchful at of out, given fraction waiting are opportunity not and there. patients even them mention it's are the As ready therapies, lot post you cycle know, of if that in you there XX,XXX And out a who or all could start out there any to imagine to a

be mind, clinician ready they're And patient, so there pull the trigger TAVALISSE. that with we stays to need the more just to that message top so out of with when the sees

force. So we sales And we believe are that. those I good that's why did feedback getting the really efficacy on messages. And in expand

Joe Pantginis

feedback. Thanks Got for the it, guys.

Raul Rodriguez

Joe. you, Thank

Operator

floor time questions Raul would today. the over for turn to closing back have I comments. like Mr. Rodriguez all we to for the That's

Raul Rodriguez

you much COVID, they've to use incredible Thank and of the in fostamatinib, employees. doctors ITP. thank you, take I'd potential questions. done And educating for exploring in Thank just allowing everyone. TAVALISSE has appreciated. Very been all or the the for like and opportunity to in about time AIHA for of This job us. our challenging a the an those use

difficult And for I'd these conditions, persevered work, that of they All in thank but to to do during them that. that. like

the past quarter, think the our very good we utility short and some that. this product I made we've I reveal term think milestones that progress for in incredible of coming have will

And so forward Take look to the like for - your that, further care. giving certainly to I'd with in near and And you updates thank Rigel. participation we term. interest in you

Rigel Pharmaceuticals (RIGL) 4 Aug 212021 Q2 Earnings call transcript