RIGL - Earnings call transcript Q4 2018 | Rigel Pharmaceuticals, Inc.

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Operator

Good afternoon, and welcome to Rigel Pharmaceuticals' Financial Conference Call for the Fourth Quarter and Year End 2018. All participants are in a listen-only mode.

We will be facilitating a question-and-answer session at the end of today's conference. [Operator Instructions] I would like to remind you that this call is being recorded for replay purposes from Rigel's website. [Operator Instructions]. to Vance, conference Vice who Affairs General like first to President, I and Dolly speaker, is Counsel. now, turn over the our Corporate And Rigel's Executive

Dolly Vance

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

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

Raul Rodriguez

can updates the much TAVALISSE Mayer, I number our year regulatory clinical Eldon to Thank we have of say key financials. Medical which concluding then you, most Reviewing that We by the you are slide six, Financial and progress will today's as significant call. will give being a Rigel Officer. financial XXXX company. eight, Also stage been our year and to agenda of our with full is advanced team, slide Chief our an Dolly, then ever. Schorno, including very we remarks and with launch call joining Anne-Marie and questions. Chief and your objectives, will I today Chief Duliege, accomplished and make on provide Rigel of Officer; thank a successful Dean on quarter open Dean Rigel’s on you on for pleased, Commercial the joining fourth me the made Officer; that us more some XXXX overview took call the On a was and milestones very our

experienced enabled by TAVALISSE TAVALISSE treatment Our tremendous in approved. the approved for a also $XX TAVALISSE organization very immune we've towards turn for U.S. the approved to built U.S. on nearly product the of introduced provide ITP market. a to of for that commercial then This the new, striving be was to million one first accomplishment but patients a providers treatment in TAVALISSE in chronic novel product to adult which just months or be seven treating the to first nearly healthcare We generated sales decade. in inhibitors was new across and net ITP FDA drug was been ITP. us This and thrombocytopenia class SYK the chronic years. many was first It

outside While ITP as the substantial is chronic U.S. well. the market opportunity the for there largest, is U.S.

in for collaborations the efforts major in in largest with U.S. fostamatinib ex-U.S. put So parallel we commercializing place market. our

highly the Europe we synergistic from good U.S. the or our bring with filed very presented well. AIHA, results opportunity, outside a marketing application X as Phase fostamatinib study autoimmune of addition, hemolytic authorization a to anemia fostamatinib fostamatinib patients indication in ITP. our In furthering to MAA plan or we in advancing In

two the then range also year we I’d and finally over position of Phase in strong concluded you the On for very these. tell Japan, objectives the Kissei importantly, this We key was which existing you supplemented by for say on with year. slide to Grifols cash. now, $XXX make access Asia an Grifols, patients. call to for XXXX continue we TAVALISSE on our we excellent continuity and will IRAK collaboration on that’s will sales available bit current very potential we other an and for us our study with year focusing new additional in in which of grow more well I'll then $XX little positioned a patients beyond. assuring wide fostamatinib and in EU On partners, geographies. all in each – And TAVALISSE our nine and tell and million January. has appropriate of we’ll slide ended this This our a of in X/X therapy of In collaboration for million patients, a nine with see Most from X cash initiated program, to has inhibitor work indications. in a ex-U.S. U.S. you the

hemolytic autoimmune tell will We then much make I’d available a new new the to fostamatinib we little across a and X XX. with will you our pipeline anemia, planned. advance molecules about fostamatinib we for study have plan to of globe. broaden we like more into bit indications, the slide and treatment On Phase how

Kissei, the think an treat Eldon strong substantial this over We XXXX. situation with and entry market U.S. commercial Just with an us to with Grifols area Because Japan, and excitement U.S. rescue the we expertise largest for also expertise to the We and have identify outside for Grifols potentially and and the and Japan, you, select early continuing Asia and desire million Grifols and U.S. the is and Europe with $X.X the expertise worked Asia demonstrated across $XXX excellent infrastructure for into think in very is European for in to has the and a process to our one estimate In Europe. in of very third ITP well diligently year Eldon. week launch update. market this review partner’s prepare we partner capability signed a therefore fostamatinib Turkey. the like after with Europe disorders area, example. bring Europe collaboration the positions their used in this think the commercial call have patients has accomplished of light, Grifols we experience market now It turn is market. and in $X in of second year commercial importantly treating and PAN to global chronic Kissei complimentary to I relationships in team billion is countries in this we for in the time the a have blood major an which this is we with largest. Last and this, is They that drug. ITP will the chronic fostamatinib, this largest treatments experienced about partners gives the remind in already that a billion Grifols exceed is providers of opportunity. physicians. the to in all of to IVIG, have the this a the

Eldon Mayer

performance our TAVALISSE our familiarity, launch QX and to XPL pleased XXX and with QX, today XX, to you multiple strategies demonstrated months X,XXX were in Total Thanks XXXX of seven be in I'm gross continues well favorable in and months key execution to to in Raul. special of from XXX XXXX QX. resulted performance bottles of market to almost to grow. distributors launch to This quarterly bottles seven the grew and the million very the update sales $XX response awareness, in shipped payers just with and and indicators. approximately that provide to Physician as in continues have from led of progress go very continues the physicians, $X.X with those positive patients. shipped million usage in from Slide demand of TAVALISSE. an the

We or and XX% authorization with continue see to four XX% months. persistence approximately is approximately refill of a the at rate reimbursement rate rate patient strong approval prior

on than Now This modest XX,XXX, larger revealed estimates. slightly yet market now growth. we recent claims prior analysis the is of TAVALISSE addressable ITP is market is that which The steady the in indicates XX. our showing conducted XXXX approximately slide September for ITP

Our strategies Slide treated portions where XX. exist. the and therapy, less largest early usage on all the lines market, TAVALISSE of penetrating continue of patients encouraging heavily across to focus including of lines

heterogeneity delivers is therapy therapy. of line treatment treatment recall to great analysis And fact any dominated used no ITP that good may lines and various treatment single all there of therapies no including believe on be of steroid post a in an lunch, much showing the This across action, have optimizes because mechanism how therapy. seen can the lines. launch, ITP post and the offers slide across chronic based paradigm clinicians TAVALISSE for factors, for setting, market their treatment variability is before is to be with heterogeneous leads that different a TAVALISSE to patients. a fit lines position our you market the roll adult which each we short, All physician’s entirely were therapies in TAVALISSE of relative use finite prior select [ph] optimal no across disease is this all with On steroid the product As therapies particular custom approach an each This needs. from into can patient’s to XX. In slide many a which use market standard opportunity of in to opportunity. paradigm number so TAVALISSE

patterns to following for prior more course variability adult therapy that XX. there we is that have in again launch many Slide are treat It treatment use patients approaches flight this received ITP. of importantly that some four be here, beyond of what chronic listed steroids. treatment the examples of physicians sequences but to should some demonstrates Here, noted of lines TAVALISSE treatment

market after slide treatment four is our treatment in of patterns. just into sequences. in about examples physicians been post various claims has analysis our this launch, month many where TAVALISSE we use market, Based different thesis integrated This realized. launch see the the Now TAVALISSE being prescribing into on our some TAVALISSE shows ITP

see to being on used after is Rituximab the being you out the Just left agents. on of TAVALISSE can far see you point TAVALISSE after TiVo Slide two slide examples the can how right of far two XX. used the and now here,

multiple like to academic prior of or after of real hematologist, how examples even other in have three TAVALISSE community responded both and treatment. provide from settings, one the we receiving some world cases I’d oncologist Now actual patient’s to one received

On was He then comorbidities old in which This seven well. male the count TAVALISSE other therapies. platelet while physician. to was count down his XX these XXX,XXX. patient to actually with to one treatment, to TAVALISSE was led XXX,XXX diarrhea some to refractory TAVALISSE count XX,XXX. therapies which month many most platelet effects patient XXX,XXX. platelet initiated tangent This of other gone later platelet side presented the After year continues and and to went see of recent man slide XX,XXX. treatment a the He you the low were had platelet in initiating summary This on doing experience had through about therapy. case see through a refractory highly patient the with is the In response of refractory highly patient year treated to of multiple by ER left of lines count middle no count count platelet needles and you related old rose courses his which during an his of and there XX rose that a of zero. aversion remained a and discontinuation on and TAVALISSE treatment experienced

physician other we see higher level physicians. on XXX be platelet This resonating XXX,XXX. therapy, point physicians the XX%. XXXX, insufficient a in attributes the TAVALISSE awareness of was platelet symptomatic who patient was survey continued and quantitative lines the to found another this months surgical example old level a The On steroids. of XX launch after are an and and procedure. pre-launch January XX man with how unprompted year utilizing required XX. just as early also in of of response with TAVALISSE an had slide, to such right of awareness, placed a over We the awareness hematologist in conducted are and latest increase TAVALISSE in and for count addition X% side four familiarity October the a of is count Slide XXXX. well He oncologists

the relative with safety, TAVALISSE positively as Additionally, increased difference access no to to had easier XX% injected were physicians slide and They data grow since still experience for or perceptions our some attributes continue administer over XXXX. and and XX, significant there it in therapy. months room but is market significant much positive than familiarity And treatments. and their just findings, engagement. respond. same trends No other on difference continuing with much four these period, ability leave These and infused finally momentum for we importantly opportunity to clinician TAVALISSE perceived on of assessed these physician the and through are see all to and to for plans the also tolerability after future, expect

three-fold: larger three, early a one, the looking Number patients therapy access number Number physicians into of lines support Number continue of two, of adoption increase physicians. move TAVALISSE objectives where exists. are forward Our TAVALISSE. with using patients to and larger portions with and

and We access enhance which additions our Our some such patient and support team reinforce with further about with and share facing patient five educate us comparisons the important physician more will be with identification, clinicians, value clinical assistant. include, customer and support allow strengthened and evidence future, TAVALISSE role key nurses making proposition finally, strategic staff the physician clinicians TAVALISSE, community the increase communicate of management, to to will further patient with office payers the as patients. team payer generate in to inhibition, continue sales TAVALISSE. and SYK further tolerability to including to near the our utility And reps and of engage

also that of finally, And familiarity on build through year. some awareness patient TAVALISSE. expect support efforts publications on physician clinical next additional has now will community channels and education utility We various TAVALISSE the over with we the

conclusion, seven well. to the So go in in very continues lunch months

I to will and pleased to moving see it are the turn And Anne-Marie. that, our execution forward. over We with with confidence performance strategies favorable of have

Anne-Marie Duliege

December includes the I you, slide are last launch an U.S., and on I review also TAVALISSE at how extension a great from face-to-face in We're of information were while all of Society publication doing educate community. of in available planning our just things strategy. with we I data interest American for like begin further collection the to globally midst to to this our Jim in with recently was key database for of exciting the was for and working manuscript data product we Collectively fostamatinib post medical presentations was mechanism was opinion in Hematology within efforts American by our leaders Thank tool opportunity marketing would major noble to the receptivity accepted the these draft our utility. commercial ITP leveraging and action. our as we preview world from the conferences, Hematology. highlight its to very ongoing It publication part the our XX. Eldon. of Cornel, educate analyzing as patients data and the them make with manuscript data real fostamatinib with also physicians’ expose of will a force In supporting for at the drive and to presented the Journal of overall function fostamatinib will but of on and the at Along support our long TAVALISSE encouraging. physicians Dr. to our moment, sales in commercial in in Vessel chronic conference presentation. relationship team in for study will a help Most chronic ITP tunnel. offered of oral meet term the the for team

ITP in European EMA our for the mentioned, in As previously have process. of year which fostamatinib began was authorization application marketing Agency, medicine the by October last we validated review

received the milestone are first of The to. process XXX question in day we which the is responding have and

that timetable process, on expect in that there this for to I questions, While have received. on the no specific of we surprise any types can were question cannot Based we we comment end of to the EMA of the Phase launching expansion by hemolytic the early fostamatinib with in we a Along program globally, year. this are stage response anemia. immune of the from our X say

working currently to sites the to with months. patient this and and coming in We are participate expect study the recruiting CRO enroll the first in

of worth lot which team our effort, other are such a significant in still Importantly, exploring. inhibitor there indications as the SIK being is done by a on work research fostamatinib

update. research, in to As happy progress an we be provide we’ll this

ITP need trial, fostamatinib. exposure extension approved talked with TAVALISSE term response slide some an oral label and patients a on chronic We’ve how additional so fostamatinib X which insight we into respond was efficacy to XXX that at and is last extension turn open slide FDA this show give X XX On bleeding. Now fifth program, data which of we from have wanted was data data to Phase study. which rate XX, on incidence a overview we on the patients the in I in to of year. December, long provided basis today the the to These the was patients month therapy, previously, the XX, about the Phase duration collected. for provided long the provide the to response This ASH of that seen rescue I we our highlight for therapy the by the to the NDA will have trial presentation chart last

for the years. are response and of complete response, months treatment. patients in the The main three that XX,XXX of who Some patients the a sustained Therefore status of time but platelet with are for the overall was March count patients is date, are are because who the XX% exposed treated treatment months. on of have first were takeaways also on over staggered were for who have study, a which drug XX line the stayed XX the response, dropped to demonstrated who of definition responders patients fostamatinib latter not orange which some representation were on there for long in criteria. the are treatment. X some start but a patients also of for medium quick the seeing not who met the study. response. who staying based we yet These other the from fostamatinib of of cutoff the XXX the patients been patients definition weeks there provides still XXXX, as Phase And this are met the notable not overly data But are term platelet These count patient of time. on patients What platelet achieving have overall atlease count

staying is clinical However, of exposure, On form we rescue this in on they XX benefit for placebo whether some modest we of count some patients benefit. make the platelet derived overview can the therapy platelet, treatment, or provide assumption patients. of increase that slide of versus fostamatinib form an for adjusted a incidence

and rescue who As of fostamatinib there need placebo overall have reduction patients. compared is a of see you responders fostamatinib the when export events growth drug. the adjusted the XX to the a those on incidence an and shows Similarly severe achieved incidence placebo, therapy other rescue all both can patients adverse response overall severity in on demonstrated in for event. also lower of patients, bleeding have for and not a in events of to We compared events of hemorrhagic see responder with patients reduction slide that Even number the hemorrhagic therapy. the

of have term over of to an XX, the slide the adverse use Moving events we overview the product. long

in it the exposure, which plus collect on is This relatively Responder versus an with happen of unchanged frequency of on conclusion you with extension years use side, years information on of As XX indicate response conclusion reduced patients increased that the no see, of patient episodes. accumulation XX% the had count, remains patients’ the early column is randomized medication fostamatinib. and randomized reduced bleeding platelet XXX events from had the as the of XX, and study, right which study would rescue that profile exposure. to there fostamatinib. slide is – overall middle can issue On most on

an Some detected was period for Fostamatinib of well term patients new of No treatment extended low who the were time. with safety time. fostamatinib. treatment tolerated continued period toxicity of long overly not cumulative was extended during and signal for responders the an

Phase update on X I Finally provide hemolytic trail. of XX, the on autoimmune would an progress anemia slide pivotal

begin upcoming this Our objective top for is this already in Efforts enrollment priority place. taking toward are XXXX to trial.

the be with U.S., four final anticipate of person We working are I with this XX XX over year, we that, patients will We the discussions in a a patient trail, drugs in expect and the patient turn will months anticipate our take Canada the trial to be to Australia. the Europe, to and enrolment next on XX sites data call and patients in CRO months. will first of that enrolment on placebo later. so will the XX This half and an in the about first will six year. are With with readout that is Once Dean. trail, within

Dean Schorno

is Thank you, some slide the from Anne-Marie. of highlights Starting the on here quarter. XX,

quarter fourth of quarter. shipped of bottles of clinics, shipped the were the channel those results bottles remain distributors’ in gross of our $X.X end while specialty were the bottles in fourth those at million XXX XXXX, our For of product and to XXX XX sales. patients to distribution

For begin $XX.X bottles shipped the on year our resulting product X,XXX distributors, gross in of XXXX, to with May specialty full of launch our million were sales. to XX,

of a bottles December remained our distribution channels. in As XXX of total XX

recorded returns, net we of of allowances net adjustment. For of chargebacks, from rebates, the quarter $X.X estimated was of to sales of $X.X million, products co-pay which net XXXX, gross and TAVALISSE other discounts, fourth reported million assistance

chargebacks, the year co-pay For rebates, million. product reported recorded million, sales of $XX.X estimated net form returns, was of discounts, TAVALISSE net of allowances assistance, full we of again XXXX other which $X

the to was me for our sales. growth quarter gross Let approximately that product of XX% fourth note net adjustments

net year sales. full gross was adjustment of to For gross XXXX our approximately XX% product the

XX% payers, and will remain of gross-to-net may first around our currently expect some XXXX. public during to we with private While we we during XXXX, are quarter continuing fluctuations both experience the gain see and adjustment

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

issues launch work the Medicare as year, moderation are full through anticipate While hole. into for quarter their in of reimbursement quarter we do phase, our growth first and we a guidance two typical patients not donut the plan as first a quarters do XXXX copays such the resetting provide we as still to

product As be we mid-single growth growth a through to effects, work of quarter sales Progressing on rate next of digit the the quarter first the net higher. quarter first these to in result, compared to we XXXX. XXXX Once in can the we sequential as slide. expect see fourth

addition and In payments year we of million product from to both net Kissei our the sales, revenues quarter $XX.X to relating $XX of upfront collaborations full the reported the million fourth from contract for XXXX.

We expect the remaining XX deferred portion of recognized approximately $X.X the over million to next be months.

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

about and are XXXX full product X.X% We net and for the year quarter X.X% fourth of of respectively. sales the

reported For quarter fourth fourth of XXXX the $XX.X to million of of expenses costs $XX.X XXXX. we million the quarter compared total and in

costs expenses party year reported compared we the was full the teams, third as and our related $XX.X For of primarily for commercial cost medical TAVALISSE. for of $XXX.X due million affairs commercial to personnel XXXX. XXXX, This and our full of total costs as increase to launch year million the well of to

million in costs expenses, of me note, Let XXXX we comparing the fourth of quarter-over-quarter quarter XXXX. and saw to quarter increase also $X.X the total third while

and costs with to to of levels. the increase primarily quarter quarter the commercial that XXXX costs. fourth periods last be This than expect and timing last related XXXX we personnel activities, clinical the due related expenditures, we expenses year-end the quarter-over-quarter the we of first Also increase saw in the less as and to to total along year same saw was year, similar in various was

net For fourth million or the net XXXX. per fourth quarter $XX.X a share compared or XXXX to $X.XX reported loss we of the $X.X of $X.XX income a in of per million quarter of share

of share year the loss per full $X.XX a million XXXX the quarter of $XX XXXX. a or reported we $X.XX fourth or in of $XX.X million loss compared per For to net share net

quarter the million. XXXX Moving with to XX. of approximately investments slide term on We of fourth short cash and ended $XXX.X

fostamatinib XX% to in with a million payment XXXX to payments and $XXX.X million Incrementally, agreement commercialize double along importantly $XX credible license reach with end payments be $X.X pure S.A. royalty During minestrone will payments net potential the January sales. received XXXX. we advance before a into of entered digit which commercial and is of based in paid collaboration million of anticipated royalty which related with we net upon EMA for payment fostamatinib, includes sales We of Europe. million approval which the receive $XX.X milestone, regulatory upfront to on Grifols, a stepped cash may

Let cash will the payment. a recognize which relevant of other result XXXX as the recognize in contract approval. XX% beyond. me been $XX recognize other which If review during remaining million anniversary the second of will payment million up deferred fostamatinib We’d for minute pay of note, we EMA time in and these potential XX% to upon a front would the Grifols. Grifols million Europe, territories. million $XX all circumstances, expect has portion It by ongoing is payments revenue terminate approximately payment EMA agreement first deferral a indications. fostamatinib accounting the of XXXX of of approximately the this to the expect certain and to after regain agreement of and limited to XX% during terminate upfront approved from upfront in ITP to option and all and Europe spend the expect $XX six the of we approximately have million rights their of quarter revenues all the ITP, Within commitments the we payments to the Grifols of of for not treatment entire in will to the the Grifols is frame month would of rights $XX in upfront contract also the autoimmune $X In anemia hemolytic have context

cash Let our me to now turn position.

million along now launch, strong $XX position XXXX EMA second our into certain Given to TAVALISSE will growth in January extend clinical upfront potential $XX now expectation I’ll year for rate commercial programs. our million our in payment Grifols million cash received of provide expect of from back with the continued XXXX; half sales the the the call $XXX.X of in the and cast payment continued upon approval Raul. turn expansion of of run our and

Raul Rodriguez

call A Thank Before year! key XXXX. we you, I'd priorities our good questions, to for the to your summarize open Dean. some like of

success to available U.S. We to will making TAVALISSE patients. our on early TAVALISSE build the for in more continue

expand Europe with will ITP we our in launch availability hope globally gain TAVALISSE in of in partner to We XXXX potentially Grifols and approval Europe. and the in

and trial and opportunities finally molecules enrollment are global X fostamatinib; initiate and will indications IRAK with Phase We autoimmune anemia, portfolio hemolytic of new will our for of partnerships. our we broaden molecule

this year think our best ever. I will be

your let So to with turn the that, questions. call me over

Operator

Thank Instructions] of Rama you. question Anupam Our comes first JPMorgan. from [Operator

Your open. line is

Anupam Rama

Hey thanks for the taking on progress. question all congrats guys, the and

a of Thanks you of call guys other tracking is account TAVALISSE could the I the the relative much. bit a thinking ask lot you metrics. different, wondering penetration question are if so penetration in little to how tiered top about how terms your awareness and some On focus. expectations I'm of accounts talked then the decile about into

Raul Rodriguez

characterize just from me levels awareness survey. those a broad let and Sure,

access adoption see great degree more deciles the to I you of the the very the penetrate. specific we sure decile that therefore can deciles be upper to a that volume we're know prescribers lot in are, and difficult However, with do pleased you – tell know over to quite I’m of you we've yeah, can of I front a more that, that, difficult higher in actually numbers confidence because as was there that don't seen you good have know which me, all but

to there's relationships – that since been customer able were have a lot access that sales give We the force product. a a know therefore I'd to I – as we you to good across So very a is accounts. experience number and before with know doctors the the long the good we deciles, unmet seen factors, very which think encouraging. which said proposition as are all due in to get it’s team. some facing of say sure of resonating, is the I been need and you experienced value the have a I'm you know that credit we new know marketplace, you adoption has But time had

only, be So that that with I course, and think early block primary still It's know thing. of primary, very the the the would right. you basic but not tackle

it we do figures can But office months on we're physicians are that of the because go and course stepping limited benefits many there We their about of you which the in new accounts can and to they there, colleagues. of time to just of bigger based conferences and with and really change behavior know takes the be levels difficult. more, get more know to learn with of with to access product. to attend information going the level more and up be so regional you communicate access definitely access, of prescribing engage get course these launch, medical seven the required the be So frequency

a having larger at the larger we're Additionally, conferences. and larger presence

able but I'll for is programs So at very our did was ASH we we attended bodes well that great had on our conduct and I mention speaker XXX mention future. peer-to-peer I launched received. just we've bureau. year And We mentioned sales our and doing thing another and that bureau turn success back, is, example We were last about well plan do well expand expanding last and think so after and more force. the programs. sponsored it symposia some launch I the right we and to for the with – I'll will bureau been But we area CME two again,

we’ll as as as well team, access. some So well, the management additional further we increase adding to think account facing customer that of will be marketing, members help incrementally

answers hope I your question. So that

Anupam Rama

the Thanks so taking question. for much

Raul Rodriguez

Thank you, Anupam.

Operator

you. Thank

Our line Jefferies. Kyung next of comes from question with Yang the

open. is line Your

Unidentified Participant

for is question. my thanks in questions two Sooji filling may. [ph] have if I for Eun, taking This I guys. Hey

Asia is one partner label second doing in to guys TAVALISSE if first off provide approval some be TAVALISSE then And The question Is Kissei you have get [inaudible] guys so for additional Asia? IgA you. in far. updates the can nephropathy. on to any trials in at Thank going seen you is, of uses

Raul Rodriguez

Yeah, this take I’ll the is first Eldon, one.

in have We we of have visibility don’t seen, that the called you our know of level hemolytic There that yet. that. visibility, haven’t demand of we XX% we channel in label what We that so on IOD we’ve our into as anemia any is do not but have based about demand off not yet. seen have of seen of seen use good as and XX%

Raul Rodriguez

could IgA our I to relative nephropathy second the answer quarter on partners.

study results the after a As Phase just required received reasons, trials variety for X FDA. with interacting size not to our proceed the from the you know, and decided we of the IgA nephropathy of U.S. in ourselves of the

yet, They in a Asia, the the might there question. they larger interested as U.S. is proceed IgA a decision but be is Kissei given Thank that of Asia, more in substantially area haven't with the and for partner speaking. substantive bit relatively this to than opportunity opportunity in our nephropathy may much higher in prevalence and higher the you your there as made that. However

Operator

you. Thank

comes question Capital Do the BMO next from of Our Kim line of Markets.

is Your open. line

Do Kim

for thanks questions. my Hi, taking

partnership. involved the just does When EMEA interactions on do TAVALISSE the question take First in European ITP in they negotiations with responsibility of filing start they reimbursement over Grifols Europe? or the after your Are approval? for

Raul Rodriguez

The latter.

really given forward better we successful it to U.S. have with position So partnership the we that responsibility we Grifols the put best the of amount to filing the FDA MAA really that approval, together that towards case that for best moving the In and position when work. we're party accomplished are then that. with do allocated on Europe and in to just of positioned execute the we do

responsible so the and ITP And be of most infrastructure responsible for capabilities to the price Europe. and Europe. regulatory They for in getting in the you various rise for know XXXX in we an then Europe all in pricing leading likely in countries that various to countries, some requires the will approval the interactions, engagements as are

do what at We what's they definitely will best and do will we're best them. for

product positioned result. approval on a going Importantly, well we does to because Europe uptake full the be prepare they the they the to position a as were in almost and year think a are a in it early to it enough to come the about plan have advantage, and launch to they and able them real allows deal faster have for that's Europe, how launch execute sign that in the that territory. will And when

Do Kim

there And give Are your were adding helpful. more that's a you about indication more in you force anticipate because expenses question Do coverage? for the what addition great, be in XXXX? you operating in Great, sales reps. think will some sales gaps can the you sales expanding of people and do

Raul Rodriguez

a was manageable those were XX%, force. it the white that provide additionally with would treated covered the the sales that little covering folks I'll have, prescribers. one XX% for of not yeah, that areas there expansion, territory size we bit the of of before a say So more there take were roughly more was of the number so of dense a some space, I Yeah, was on number terms patients area in of expansion, but that. a some the did of number to accounts and of very and in

So driving time a and less and by traveling as territory. there this and factor were spend our this well is the affected the larger to more that them time you will enable interacting those customers and expansion around know folks fatigue with folks with small

covering was territory territories, it a frequency a with the doing efficient that. of just region getting bit mostly our more for but increasing little So

Dean Schorno

little I our And clarity plan from XXXX, said year prepared don't so but in then to expense give we can more in with full respect I guidance, to what bit operating comments. give a

operating we an year So into QX of of QX $X.X a QX million. of uptick to $X.X we did saw from Last in million. about drop expense see ‘XX

be quarters a to $X QX. a for So that before XXXX. an than in million. into of We $X.X expect It to then again we’d few larger expect bit million, the could little bit see see uptick drop say going a that continue we

some to where of are that we be XXXX. at we’ll So gives from into you today hopefully going where direction

Do Kim

Yes, that’s the very you. progress. on Thank helpful. Congrats

Raul Rodriguez

you. Thank

Operator

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

line Your is open.

Joe Pantginis

different is to rates saying Hey wanted question, obviously and and nice guys, building and I commentary but still the the the heterogeneity increased the of are in the of see types prepared good the for lines in attraction my especially to drug, to the the the days topic and you afternoon, early its my preference experience of question in. launch remarks a of reorder used preference being patients by lot but TAVALISSE. the with

this combinations have curious efficacy, introduction, reorders length, with know for for side the with at to that of So know point the for regard sorry lack effects, of reasons just you you what you.

data might of have? kind Just curious about you the

Eldon Mayer

in business it are in still There represents earlier, and a very caveat again we is of updates and so portion we’re you there and did IOD say that assume I you I know some and with this I can is is want called that's with can of know the provide course I visibility as early as here, to – segment full the repetitive, a mean to don't that something I and mean with that our this want so as business, Joe that's our but the provide directional Eldon that such Sure, probably we – Yeah, but very mentioned you not I you tracking XX%. closely. have do launch we're be you prescribers of when tell. we're tracking reorders, said

more how growth to key prescriber comfortable volume it time. a we expect we with them you over our increase takes driver though become is of do can sales going that as seen time this the to product will will so think started forward. we prescribers But for patient responding, but be and a a evaluate in that a lot know of one and patients our say So with on that they we've two base, therapy

physicians XX% we you even of that that on You about drug know we that patients have subset have pleased far more productive. their in roughly actually know were multiple so are

So we do expect that to grow.

are moving populations there more have lines physicians all it patient treated. gain they'll gradually using As across experience, think lines earlier larger heavily be where more into less it that we been

I what that specifically asking know but... question. hope that’s I your addresses you if are So don’t

Joe Pantginis

an efficacy physician say was No, lack as example. a or of just lot, where like just it you does I help profile reorder really they're particular on not a are curious based an like events adverse specifics from and seeing if a

Eldon Mayer

used No, But very, and all you seeing had that but know initially there one patient including and product the an physicians exhausted who across the are is the provided as right – there a that did mean rare there stated our are that a and have the are lines. us, so candidates. and earlier an don't earlier pent-up back also concern in I signals that options disease of the Joe we area of before, no very typically did phenomenon force very know about sales refractory I are, being and the we we many lines, a example you patient majority of of patients lines with where can quantity was respond treatment I in have and know will patients of what our as that significant you talk is of demand – be where there product not a later products, so right benefits is are go this refractory, the number course

this so is very know that of not type markets, us. in of for So you launches some with normal, anything concerning again,

Joe Pantginis

Got Thanks lot. added a it. details. the appreciate No, I

Operator

you. Thank

the land with comes Our Piper Allison from Bratzel next question Jaffray.

open. is line Your

Allison Bratzel

on of question. a label Kind of last up a before three-month follow- sufficient question. The discontinuation actually the patient, recommends trial response. have the taking for don't a thanks Hi,

in should we So months waiting sort the as you hits patients I of month practice. into first churn see before of guess now discontinuing does look that that or you're, docs months expect three to know three several actually more how wave Are the launch, mark?

Eldon Mayer

question. good yeah, Okay,

let XX%, actually just strong majority the first more of rate believe refill a mentioned, of all is that just very rate restate that So what patients are persistence have know or refractory. we I given me which you we

again, supporting the but move we we example; and earlier that better the as how how use are get of them physicians with and line as launch, to that, are they as AE at additionally product more into that then they So – managing how so better for we and the think drug as and in such diarrhea experience line with early given drug learn modifying months gain is some how our that dose we expect did up Having we know launched to are was before one patients dose background, that discontinue believe we you key likely we product when maybe the escalated. messages did that giving see more seen, therapy, we’ll and yeah and them and said who believe stay that improve. who we on as full that three there not of response anecdotally a heard there rapid the is physicians were all

to back them. what said learning physicians to for about how this I before this support So use goes best us drug and to

in early stages is this of area So normal an learning’s of launch.

have forward. our That a it's We patients understand portion don't have think that but any with a a wasn’t of don't an and is best how bit sure significant you, numbers and go think back they making great that to that for so I and and anything opportunity we physicians little I us going for yeah, is of them support but to use see did those concerning. opportunity this drug we

for I to right the us going think an opportunity the get it's of actually treatment, and forward course. patients also

Raul Rodriguez

we with XX% the very fourth are at month. No, happy that

the that’s and are benefit, a they they that's reimbursement didn't encounter – think the going if they clearly a very good stay wouldn't if a because AEs on were they derive clearly indicator and a is not obviously benefit long encountered not patients I – and obviously issue. that of deterrent having to any an

get we doctors and that Also improve Eldon to we as expect get as response well. very help XX% mentioned, expect lives with up which creep that we think So of is to in that happy I as used fantastic. rates earlier we're others and more words, therapy as that more, experience

that you we're as looking to sharing progress. So forward we with

Allison Bratzel

you. Thank

Operator

next Instructions] line [Operator from the Citi. comes from question Yigal Our of Nochomovitz

open. is line Your

Samantha Semenkow

Hi, on for question. Samantha for up taking just Thanks is earlier Again, question. of to the some on follow Yigal. this our

have the launch I prescribers just the that -- that you assume a did you that that mentioned patients. I you you on into have October? whole could of You in just a little that of trend is survey that have do one wondering drugs. or if about insight than bit that's XX% more patients provide was any two throughout multiple snapshot at

Raul Rodriguez

know is percentage That the trends represent specifically That visibility from survey. XX% demand. prescribers is channel, is and those to that pharmacy we accounts, we see bottles which And channel, demand not of shipped XX%, many productive don't in how our again, remaining Yes, to from are. XX% so have the the the how in the but IOD they specialty okay. our we

just that’s a no, that. overall But for that’s So XXXX. number an caveat for

are of metrics of them. analyzing, the we that closely are is monitoring these again, So one that many very and many,

I any it's with are again. there are we as know QX trends comment think can on very in trends So to I the encouraged you it's well. seeing encouraging. we We early too overall say think early

Samantha Semenkow

think the And helpful. bit, potential a your switching for that's is perhaps of you, which the that your market for thoughts that to term curious the most help for over gears value next value? are catalysts partner and I'm little you that recognize long what the one Rigel begin Thank see to programs just will we on will years three

Dean Schorno

question. That’s a very good

happy fostamatinib and our commercialization good and I think are for I with recently with two all with are for of All Turkey. put Japan different fostamatinib Grifols partnerships most Asia, we good we The commercialization place our partnerships children. children reasons. very are very Kissei Europe all for of think them in of very and in

proximate. Grifols case allow XXXX the patients end the of market, that with we for be opportunity partnerships XXXX, hope in in and to get Grifols. used will are the We really those in this of product be product product very ex-U.S. think large in at year I the this really the and approval is calendar can the

really the So mentioned, Dean outstanding the as for rates royalty partnership. immediacy of that that and and attractive is important are

Kissei So they in PMDA partners equally approval to are actually are excited. towards discussing working are an at advance Japan are how our in excited best with the They we, about as it the are of that's as not as because Again, the about perhaps and it’s Asian that. to first they and other countries Grifols that. close close fantastic then very finish, and enthusiastic there

will clinical in rates, are with clinical but this those of very point. different we stages all They and clinic. at collaborations and very from are pleased making are ones progress all different broadly progress, good at earlier Our at the speaking various Aclaris stages, AstraZeneca now

Samantha Semenkow

thanks you, talking Thank for the question.

Operator

I'm you. now Raul for question. for Thank I the remarks. the closing call showing will turn over to

Raul Rodriguez

it and by those benefiting is your improved product that throughout year. this, of thank are patients, other patients that. because I our you ITP of thank like and Well, for and move for very us your listening you you this to have to and you. now doctors its patients support I'd and from say thank Most importantly as to care. basis a how an reason monthly And valued having that, allowed those it, I in a on so will patients. do and appreciate keep we like are to and abreast hear and product is and I’d made we advances questions. approval for their to the and lives And gotten the product forward assure better they you your I’d thank weekly about Take you that support, whose the this

Operator

gentlemen, and in You day! you today's Everyone wonderful for Ladies participating may a call. thank now disconnect. have

Rigel Pharmaceuticals (RIGL) 1 Mar 192018 Q4 Earnings call transcript