Horizon Therapeutics Public (HZNP) 2 Nov 222022 Q3 Earnings call transcript

Good morning, and thank you for standing by. Welcome to the Horizon Therapeutics plc Third Quarter 2022 Earnings Conference Call.

As a reminder, today's conference call is being recorded. [Operator Instructions] I would now like to introduce Ms. Tina Ventura, Senior Vice President and Chief Investor Relate Officer. Ms. ahead. go please Ventura,

Good and Chris. joining you us. morning, you, thank everyone, for Thank

with Tim President, followed of President, today closing review and the Andy a President me On call by review performance Officer; Financial quarter full guidance. our and investor our are R&D as Officer. Aaron this then performance Executive Officer; your and more programs, Tim, Tim Thompson, slide who and including guidance our provide Chief third morning our Development; Executive take Chief Liz well. financial Aaron, Liz Walbert, year Strategy We Executive discuss the remarks will and Vice Vice in business, Research Pasternak, will posted we'll Cox, Vice deck Chief questions. Executive President and Chairman, detail. from After will

forward-looking we'll and statements our strategy and certain During the development events. today's financial making future activities, timing statements, call, projections, of business including expected be about impact

could which Our our latest forward-looking the any other morning. earnings Exchange in outlined differ Commission of Securities statements information the risk XX-K, this release, factors and actual XX-Q including with number a materially press X-Ks Forms and factors, results we and to issued and due these filed our from

You're any statements, undue obligation cautioned not reliance disclaims to forward-looking and to statements. Horizon place on these update such

over at measures will comparable presentation today financial our will turn These slide website www.horizontherapeutics.com. non-GAAP used. filings GAAP from financial our financial release, be Tim. call on reconciled now available addition, that measures In are with conference I on other the call, the non-GAAP today's earnings investor to and measures are our in press

everyone. good and Tina, you, morning, Thank

TED quarter. we operational on portfolio trial, clinical, in we progress share our line quarter to Low-CAS our results commercial next the completed pipeline, continued With drove top of TEPEZZA our execution chronic, second year. in focus expect Our and across enrollment this

last with on patients of II Viela our positive in in evaluating the value we made year. at the accelerate call, of we the line saw trial results of a Dazodalibep executing growth. Sjögren expectations. have for TEPEZZA the announced our top is least on exceeded we second syndrome, the quarter progress business, from Commercially, also our across in the acquired mid-teens we XXXX, growth expectation rest Phase And validation we to actions We pipeline lot where of discussed

of in now to than with has launch performance more the done the expect well, we sales continues continues from immunomodulation XX%. and nicely, The methotrexate KRYSTEXXA U.S. with of quarter. the exceptionally more doubled quarter, and XX% we progress year. growth XX% this to team our drive to of going growth XX% for again than net Our Generating UPLIZNA strong relaunch full

well. strong as Our rare digits in the typically which disease medicines, generated low growth single grow

a As year we result, adjusted sales and morning, EBITDA net full increased guidance. our this

We for in discuss goals. and additional TEPEZZA also across an the good executing strategic peak increased annual performance. $X our KRYSTEXXA, both I'll We quarter aggregate net very billion. sales our third now board, feel on expectations by

and expectations generated quarter $XXX First, million. third on our it's sales TEPEZZA, with net with track of

time actions to expands It care and of we sales find TEPEZZA effort need. and across with the drive more refer reach important our of expansion most of ophthalmologists are many their the our to education, the thousands the to Now, But engage TEPEZZA our to gives these is growth TED of how and or never lack specialists. Ophthalmologists force. tens TED limited representatives sales of of patients TEPEZZA they of due potential ocular patients. best taking patients, understanding endocrinologists see endocrinologist,

what X,XXX targeting ophthalmologists and efforts DTC the ocular XX XX,XXX this specialists approximately we to about third helping expanded of representatives including We sales and get therapy. adding With team. TEPEZZA quarter, expansion with critical end now force, approximately patients along to XX-person to our this are the team previously So about the sales are total on physicians, of completed endocrinologists. expanded XX,XXX was this at an hiring sales

gives the the of first by whom training sets out completed we new and are and of calling targeting the to starting so the their based end majority ophthalmologists And of information We've physicians. expanded had capture, physician and greater of build on broader October, a in were from endocrinologists, team we enhanced relationships the claims with right are engage confidence field data engaging on which time. for us or the many even increased with our set

team. early, feedback heard still is it we positive have expanded While from the

representatives on are Our expanded physicians learning TED. calling high physician us see they accessed are very haven't interest into getting new very excited offices in we about sales we the TEPEZZA, showing The we TEPEZZA team's growth next are to We're the to mechanistic team, and for about potential impact expect to year. the willing the recently of and highlighting campaign, updated an rationale TED. drive launched support additional marketing field see treatment To further for in the before. begin

our by diagnosis. new Both highlight symptoms of unseen to patient an of to Our an to the seek and urgency TED supports broader exam or discussing aim also efforts drive campaigns delaying campaign TV the eye create treatment awareness. and consequences physician

has patients specialist. DTC in to investment at been undiagnosed effective visit encouraging a TED continued Our

advocacy continuing peer experiences managing real-world to of strengthening by the patients. giving and best and are co-management education. confidence in of network physicians discussions focus conviction peer on to we our on is patients educating practices clinical physicians their driving Facilitating increased addition, through In

and forward. to Our the continue quarter peer-to-peer expect increase to we to moving it program than has more compared doubled second

and one other a to which is drive the those seen both is conviction than this clinical for UPLIZNA, critical peer-to-peer KRYSTEXXA and most education we for physicians, of effective more have approach TED, diseases particularly co-management medicines. with ways of complex As is

services our and more reimbursement spending and addition, team on is the In patient reimbursement time process. focus

to be process burdensome discussed, for are specialists some While especially coverage the not as can we favorable physicians, ocular for overall, is it. accustomed have who

patient this team work enhanced educating best and offices services reimbursement operates, on by to our work to physician process. we how hurdles We how have reduce through

out with gives actions, very right strong key the confidence coupled with these medical All meetings of target track. fall the us on momentum coming are of that physicians we our the

We the continue expansion assumes to least beginning year next we we high teens, full of to XXXX. net in mid-teens growth efforts our TEPEZZA net growth continue sales sales an in sequential which as fourth impact expect to year, With at to in growth drive modest move into XXXX the quarter. expect have

analysis the the outside for opportunity As over last we've on several United we've discussed the also TEPEZZA further been conducting months, States.

as was of as other and $XXX then, the looked annual on million back net markets. Japan, intend reevaluating more well and than launch more primarily guidance where international focused markets Our prior ex European peak TEPEZZA. to U.S. related Since the at we gone sales closely opportunity we've

and the these we We expectations have with peak than similar need launch updated incorporating plans in unmet increased ex-U.S. incidents our Including a prevalence confirmed now rates outside to in markets have expectations and Europe, greater $X to billion. to there our for sales TEPEZZA U.S. is annual significant of U.S. net

is the TEPEZZA launch progressing outside to well. U.S. work Our

to our data underway. Low-CAS chronic significant complete believe development which and In trial medicine to in trial, Market submissions include OPTIC both in preparations well this TED trial uptake we by from Phase our year-end. regulatory Europe. We in are our launch will Europe, there for clinical well expect we as drive III expect Japan our enrollment as

In market with which time, immunomodulation of that XX% sales than net was We outside peak from segments, estimate rheumatology more perspective, We to now increased KRYSTEXXA Putting it's our expansion exceeds years momentum both launched X including driven the And since of million. adoption by we in billion. strategy. our we KRYSTEXXA peak single beginning since annual we immunomodulation, in This increasing expect was nephrology the this patients than few our XX%. sales year, increased been and XXX,XXX exceed and in U.S., U.S. performance than more meaningful the immunomodulation more $X global immunomodulation increased TED now through the early net this months TEPEZZA net low there contribution short $XXX part expect continued of annual in with XXXX. FDA addressable from a where are to greater driver our our to increased expectations saw than we to third sales major digits billion.With global again use XX%. expect XX%. use approval, quarter of year-over-year U.S., launch $X

in educating on working are new-new KRYSTEXXA efforts physicians of methotrexate with profile Our well.

We seeing more KRYSTEXXA are receiving that physicians data. the field have positive from in feedback the confidence high MIRROR after

continue third year. strategy the more KRYSTEXXA full nephrology third clear about deliver physicians clinical had prescribers the quarter, quarter, third fact, immunomodulation a end to has all submitted of been quarter evidence In enrollment not our half and have prescribers in we at time we This rheumatology relaunch and conviction. This least of patients increasing or strong than been by the XXXX. In a forms compared doubling of momentum patient more year Both therapy in results. through had patient on to prescribe has of year. the led KRYSTEXXA new nephrology as than starts of the who and have same nephrology, in nephrology had last our is of the following to

sales within As for allow expanding space. last the approximately reach growth we mentioned force and nephrology our by KRYSTEXXA continued quarter, we're to greater XX%

net full approximately growth year XX%. our strong billion. momentum sales raised peak the annual greater Given And to sales expectations to we our U.S. with $X.X than KRYSTEXXA, XXXX guidance net

more with This net is Moving medicine we U.S. it in growth second of have on the trajectory. of put We an strong quarter, million we've doubled consecutive another and million generating UPLIZNA a strong example to net UPLIZNA. on underperforming is the sales $XX $XX how our taken delivered another quarter sales. year-over-year U.S. than

in see new and consistent to patient We steady continue growth new and starts. prescribers

Our and XX% increasing to Phase than from a at medical medical analyses the the of the drove had more trial. record on strong mini fall programs quarter. education commercial disease multiple peer-to-peer focused number activity of presence our III a third in team We and new ECTRIMS, data presenting compared by second remains quarter,

in progress. making is also Europe good Our launch

confident UPLIZNA We are in increasingly in prospect for NMOSD. the

towards track annual than on peak global of billion will indications. $X our well turn are now call I all to net expectation across We more Liz. UPLIZNA sales over and potential the progressing

for everyone. to to is Thank our more and patients in of Tim, R&D underserved goal efforts morning, The bring particularly good you, communities. in need, patients medicines

II or announced Bio. collaboration in we option with QXX R&D several many diseases. trial, positive low start new completion quarter, designed in antagonist involved a in trial to our our third autoimmune a is inflammatory pathway TEPEZZA and central with the CAS and and Sjogren's syndrome, Phase milestones, from enrollment Dazodalibep, important including results which agreement I’ll CDXX-ligand During block TED our Dazodalibep chronic

several we is of reminder, of acquisition last As our X biologics this with development-stage year. that a on brought Viela

can dazodalibep therapeutics evaluating trial. the provide we chronic results we disease, moderate saw no novel we glands, including safety saw fatigue, that to autoimmune this could such patients on like approximately physical medicines approved. XXX,XXX believe number we some of acceptable tender in today, to supportive significance high sensation from constant Sjögren's trial affects shared first and while can neurological grittiness The is the debilitating tear body evaluating progress. were areas And systems in impact symptom. data are is population the the suggesting that As to dazodalibep line disease ulcers. some salivary to debilitating impact quality of top enrolled most severe could and fact, populations exocrine top localized statistical Sjögren's a and a patients disease disease molecule, severe placebo. function this populations, potential results dryness including affect In arthritis all this fully severe patient's between involvement, dryness II from positive of referenced, mouth XX,XXX which of many of validation trial, moderate disease associated meeting manifestations symptoms. disease the can the achieving corneal and with on disease numerical in cause Of joints, X the for activity top gland. modifying which lead the patients results, separations systemic Other arthritis, swallowing, the various is on patient's with patient irritation to in cavities. results second measures, dysfunction a second swollen population XXX,XXX ESSDAI in endpoint we to and primary various Tim commonly Viela greatly eyes, this of top We trivial, patients. the response marked the pipeline, pain, impacts across with for the can localized bars of more it dazodalibep II rheumatoid Phase very life. the profile systemic disease the From kidney lead positive of recent is life. and to are several we women. also systemic And the across Dryness the in severe our moderate aspects biologics. the the disease a and the than Excessive would of ESSDAI, appropriate following activity with dryness showed symptoms, X-point with impact of improvement, can continues important and activity continued patients be chewing, levels patients in with development. and Sjögren's line and U.S. patient a the ESSDAI sound for patients and line the the function the moderate X improvement, of score. that shared Dryness is and systemic measures a reduction create In was of Phase the September, of fatigue in in and value cases, readout patients in perspective, trial with to impact is from impairment, with lymphoma. pleased can in Sjögren's also studying as line syndrome is patients patients sexual positive

moderate we results severe as systemic received far trial patients placebo working clinical we look We'll next initiate with forward to moderate patients went design We'll III with with dazodalibep. sharing treatment which authorities And activity to new full on look our patients initially we to the program, next to from year. as data regulatory for our from and including to for results disease results receive also have Phase localized year. Sjögren's to steps, to have So then who with severe next forward plan symptoms.

we as our IV trial with TED September, patients In score, TEPEZZA. enrollment eye completed in Phase in our activity to to clinical disease low Moving thyroid referred randomized, placebo-controlled a chronic otherwise trial.

TEPEZZA profile patients While payers. design patients, its for physicians a with scores data low clinical these for for indication TED, in help activity broad and has will

trial We in expect quarter the top data line XXXX. this second readout the from of

the As additional patients as physicians medical who data opportunity regarding a of Tim their presence TED. key TEPEZZA. connect this strong with physicians at giving referenced, prescribe its to and we had diagnose TEPEZZA and meetings of as CAS. several TEPEZZA's who growth at TED, each includes presented the throughout stages of upregulated This action refer analyses TED role fall, low us treatment We new well and Annual Meeting, in the because American including that in are extensively high important pathways Academy scores. and patients all activity supports showing with data X regardless relevance the factor and related clinical mechanism it Ophthalmology of insulin-like of is of This its

Association of percentage of Annual low. being the additional an of Thyroid course American prescribed We TEPEZZA a analysis showing at remains Meeting, patients also real-world from data presented new TEPEZZA the

program. advance administration to TEPEZZA continue our We subcutaneous

Our Phase formulation year. this patients by to earlier year, in we are track high begin trial initiated enrolling on end the Ib and concentration cohort the of our TED

by the OPTIC-J well completion with lot enrollment trial progress of interest year. We're with clinical and end of Japanese Our enrollment progressing investigators. anticipate of from is the a pleased our

to other the medicines. literature contribute also on-market to Moving beyond we TEPEZZA, continued regarding our

from Phase ECTRIMS UPLIZNA, For centered around analyses presented new at the this data Conference. Medical the trial III

common variations found to the crucial somewhat that with attack. B genetic depleting therapies, NMOSD UPLIZNA with efficacy a have patients to therapies. cells, been A during with of role as separate play including analysis and cells, First, other which effectively associated that depletes among fairly reduced highlighted showing have anti-CDXX presentation UPLIZNA response such a plasmablasts plasma CDXX-positive been an B-cell

of results twice ACR, month, from who several advance As XX% gout. understanding efforts We ACR. with important to and the who for be a Meeting, showed will recently with uncontrolled of a nearly that the College KRYSTEXA placebo. fourth complete results the presentations Rheumatology response, look at received of we continued later our quarter, MIRROR first the American at care also These time or data to patients of series have this will we on those XX-month methotrexate for KRYSTEXXA. of trial presentations achieved focusing presented announced KRYSTEXXA received the

planned potentially American impact presentations function. this milestone diminished in in important collaboration asset, anti-IL-XR with kidney a have the novel those patients. not for inhibits to approach on an next antibody KRYSTEXXA to We alpha cells in patients well announced August. of the lead indications also regulation. now focused collaboration Aaron. ADX-XXX We ADX-XXX just methotrexate we the turn and program showing QXX trial the first an T is Conference of of II a Society in to did our disease This call study later Nephrology year. including with regulatory signaling will autoimmune finally, negatively dermatitis fully address a with QXX's start initiation of Phase allergic kidney announced II that over week, QXX Phase I transplant IL-X. the second healthy represents that in trial a a restore plans atopic And human as disorders immune the TSLP to imbalance Bio, as with

Liz. Thanks,

cover brief start quarter's me performance, on allocation. comment this with I let Before a capital

deliver we aware, million the reinforces in a have long-term our repurchase to value shareholders. program in and we announced our strategy September. to both As you are confidence our program $XXX share This commitment

for shares while flexibility our business X.X ample To $XXX prioritize generation remains and date, priority. sheet of to shares repurchased aggregate we cash the value capital balance million. to have an the million gives top which us strong development, Our opportunistically maintaining repurchase

IP we acquisitions milestones and collaborations, from with R&D of other these quarter third into which financial measures. expenses, business been expenses payments XXXX, development new and we will a upfront amounts Beginning separating previously, isolate with In expenses the conform to X and our addition, that licenses and categories: category transactions. noted for exclude acquired also classification. periods milestones driven R&D have have revised are asset similar non-GAAP by no related Prior we longer to the new R&D as are

cover and focus comments noted. in will non-GAAP guidance. this our third on unless otherwise results, our the I updated our quarter primarily morning Now will performance My

generated contributions net Our portfolio. orphan million, strong across of quarter third $XXX our segment sales with

for income $XX sales operating operating was million the million. loss segment $XX million. Net segment Orphan and Our $XXX were was inflammation

down are segment the market the by erosion PENNSAID the following caused entrant. inflammation We winding generic X%

We complete substantially this to we expect result, fourth expect down in as be wind to quarter operate segment and a single a starting year-end. of this year. by as the reporting And report

Our of sales. profit gross quarter third net was XX.X%

expenses Third quarter $XX expenses net expenses primarily IP milestones operating or agreement Acquired related R&D were $XXX million, expenses and our million, million QXX million. And with were $XXX SG&A were sales. R&D Bio. were $XXX XX.X% of to collaboration

Third of was $XXX and quarter rate the was quarter X.X%. included million acquired for tax expenses. adjusted which EBITDA third the R&D $XX million, IP The also milestones

have third in the Net quarters. in be was quarter rate income As in can our years, across seen prior tax there variability we $XXX million.

Third XXX outstanding shares. diluted The diluted XXXX to quarter EPS $X.XX. million were shares calculate average third per used share were earnings weighted quarter

months $XXX last than generated to million. operating quarter $X In flow XX, cash of cash XX September flow. we've more operating Third billion was the

with and critical a future The by debt we cash expect outstanding the in $X.X total cash our strong our billion. the of business to of position were role business. play in cash our maturity $X.XX is XXXX. cash amount flows, pipeline expanding and As continue development expected Backed September billion, earliest equivalents to XX, principal diversifying and

X.Xx adjusted was of leverage September well last gross Our as under to net debt and months Xx. ratio leverage was XX, ratio XX our EBITDA

our of are $X.XX from billion than to net growth to XX% our Turning morning, guidance $X.XX $X.X full range billion, year-over-year to we This guidance. announced billion, $X.XX to increasing XXXX the at sales year we now midpoint. up billion representing more

full teens. high year in net sales XXXX We growth the continue to percentage TEPEZZA expect

growth For KRYSTEXXA, net sales our to year guidance we approximately are full XXXX increasing XX%.

and now our net than quarter margin to expect less higher we to full $XX year million be XX%. business, gross sales expect sales next year modestly immaterial. XXXX be We inflammation fourth than For net of

for milestones up are $X.XX adjusted include year of We expenses $X.XX billion our billion $X.XX guidance billion. and full acquired IP to guidance $X.XX increasing EBITDA R&D to $XX ranges prior Both XXXX the full current to million. the from year billion, and range

expenses, to million which similar $XX fourth the a it we be expected including the quarter operating As expect be expenses, third fourth to range quarter, to R&D IP in as quarter. acquired milestone in relates the and are

We XX%. above our $XX full our net million. continue to to million approximately be approaching XX%, prior XXXX our interest year modestly We to to year of expense full expect tax versus expectation now rate $XX be expect

quarterly As tax we our with basis. every variability year, we on anticipate continue -- in rate a

that XXXX estimate to cash mid- to digits. in be continue will high tax single We our the rate

divestitures always, diluted full to as make our average over shares laws. Tim We could count tax share we or any which may rates X.X significantly it a incorporates year approximately expect of XXXX repurchased million million result I As now weighted will remarks. change or his tax in that, for acquisitions concluding turn to to our With be the date. shares, changes XXX

closing, continued In quarter. progress execution meaningful drove focus this our on

in had business, rare performance. to we XXXX. And the disease of our growth outstanding of the last all are actions discussed KRYSTEXXA, We TEPEZZA medicines, taking quarter and rest our accelerate the UPLIZNA

we our As EBITDA increased sales XXXX full our guidance. as a year as guidance year and adjusted XXXX well result, full net KRYSTEXXA

are peak the internationally, KRYSTEXXA sales expectations both with we we've we In annual on momentum on TEPEZZA medicines. addition, seeing the analysis have based strong our further completed and for increased

evaluating will Sjögren's trial in readouts trial This we Importantly, our look from low-CAS several UPLIZNA be to in TEPEZZA from from for and lot in dazodalibep trial disease. systemic with IgGX from There's chronic Daxdilimab, data a which III TEPEZZA potentially syndrome. you to year in focused our enrollment pipeline. the additional look look our first completed Phase We TED with data chronic our TEPEZZA -- trial, Japan, forward months. the positive our dazodalibep top remain to strategy, next our on low-CAS growing forward and Sjögren’s our data over key includes you. to II Phase II forward the XX readout Phase next readouts our highly updating our trial on our Thank Phase on executing in results next pipeline, announced line from on call. We further and patients in I II program, lupus

Chris, questions. the we'd now call to open for like up

[Operator Instructions] from Our question will JPMorgan. first come of Schott Chris

I just had X here.

first any there is I'm Or on and kind been too with you on just selling about efforts. there that my mispronounce PEF leading one, question And that on seeing drug early any has it I to change note? of trends trend the to is talk you're was revised -- The TEPEZZA. indicators Can always to of as about second the we think dazodalibep. still some guess this just front? going of evaluate

of On at at guess, the I are population, symptoms? much also localize And the some market or with is look going guess, symptom how to just say, so you population thinking III Sjögren''s patients as Phase you that systemic disease? larger program, localized to plan the about I to the do here, versus, or be we looking systemic XX,XXX sizing

Thanks, Chris.

get way mass all, to And quickly out cover encouraged just what with we're activity find just sales we their early think their we ability really out around. and on, TEPEZZA, of look looking we're and growth we're the at for getting at I by I force in there think, and measures are, we expect quarter, seeing. is first fourth As where modest and of the

what people, by and we're data encouraged we're seeing I target. are we're on we're based after we lined got getting think far. the territories right right so so And the we've the looking all the And at, right have,

expect start expect be to populations? nonsystemic the year, new the them at the out to the take impact look we of think you point Andy, and and through. you the rolling flow market we would and size And into at in this the that want training I get So as systemic through when time. to seeing where do get and it's ones it we final

Chris. Sure.

high would also prevalent very So on Liz is think we estimate that dazodalibep, in that patients for disease. a well appropriate a There XX,XXX her be remarks, for have as the mentioned who as -- with we -- therapy are biologic biologics activity. in disease appropriate that are population sizable about symptomatic severe systemic

unmet So think significant that is also that, we need. do a very

Of in our that forward. course, need data to population fully our trial on decide path the we see to from

Chris, thanks much, please. Great. so Chris. question, next

shall Annabel Our of & from come next Stifel question Samimy Nicolas Company, Inc.

a on have I couple TEPEZZA.

think I'm where than specialist So office? are what sitting? So is patients? asking low do And XX,XXX as primarily they low-CAS have where I they consider, relaunch talk the -- really separately, symptomatic can expect? treat? patients guess, to population, Or urgency extent typically have a endocrinologist, kind kind those a CAS that in ocular how about uptake are mean, to little that, what we uptake of guess population, I I needed what's ophthalmologic when is around was but and expect that the are TED Or X% retreatment, in you more they they maybe now we about there’s retreatment, the are are I from or more think right there? what through of you a rapid can can treatment. aside strategies those XX,XXX, going the XX% then of study bit in how thought this a it only I about who we And

you are to rate? doing any well? expand -- Is retreatment source that there of growth to that going be So a anything? there efforts population as Are

publication based X%. abstract on it's less was start or the the we -- Sure. It's than published, just that retreatment. with I'll

So we're not actively focusing on that.

rates. low surgeries just we If the gone their see through a you who to patients TED active look in rate the of reactivation at population have general mid-single of digit

So that range. seeing what in somewhere right we're now is

they TED To Annabel, sitting we think to an on all area ophthalmologists and/or sales require that on question, that's your but premise and going things the severe predominantly I What around have time meaning endocrinologists, patients, real So how not for proptosis we from based is severe XX,XXX have we're treatment. them. they're over focus to of us. where be are the the they force, evolve for certainly and there, And those have disease, know enough our analysis, just see at they and diplopia. patients was focusing expanded these

a matter ophthalmologists and treat it's look when total the we at awareness and XX,XXX, either XXX,XXX this certainly, to consider So we of those TEPEZZA. educating including raising getting treatment patients or in, to moderate with but what and would they're severe those refer for that eligible just all endocrinologists

question Thanks, Chris, please. next Annabel.

of question Goldman will Kumar Sachs Company, next Madhu come Our from & Inc.

Two from us.

TEPEZZA on force, street for of on feet what on secondly, Chris' bigger makes of endocrinologists benefit talking question, the really one been guess, of more picture of for kind you see for approved you of organization. of then and indication question ophthalmologists? this? Inflation Reduction both that we've and First of hearing expect when more Act kind the extent kind about the timescale and more Like kind seeing the candidates? expansion kind what And guys impact I on sales is full kind sense having following impact of is drugs from to do pipeline

is look and diseases, concept the for and candidate certainly, have think understand multiple any commenting quarter third this. to a pipelines very I heard of indications lot don't as we on rare you've having development comment something them. specific latter, a We medicine that to closely print of on. the But On the people disease rare have at you look certainly with at

or we nothing dazodalibep, small BD, an changes molecules, proposition, but look that at how it's daxdilimab this first or our least hitting in look at we're next our guidance with So sales around it's how at got think certainly, pipeline, for entirely but different certainly year. you're into factoring we as soon. on get for forward, our the going the I all to we look mid-teens To factors to we force, really growth how factor expectations to question up

expect impact. get from grow that areas and the begin as We sales year the optimal force those to throughout contribution toward to drive to their to expanded know continue reps

year to to expect we for continue and current drive what that's So expectations XXXX. throughout our next grow

Chris, next question, Midhu. Thanks, please.

Gerberry Bank of from next question come Jason will Our of America.

the TEPEZZA on environment. One in care managed

payment the Has managing the of PA on comment or initially, more Phase policies label dynamic. III more are parameters shifted it curious type chronic got how versus coverage? covering if to plans enrollment was towards Just can only criteria I of sense TED a the within you

combo sort chronic reflection I'm change I'm here then just XX%, quick you over what a trial is at the change higher dynamics? said patient positive rates alter on think one in patients those KRYSTEXXA, likely TED more is assumed help you full so or because And use And peak just high, get the wondering extent I is more pretty which a with X of the of are penetration that get dynamic getting already sales versus in where course? combo to could to the more revenue per of just given

the as accelerating you KRYSTEXXA, noted, gone to over On launch has XX%. well and extremely

in growth comments. pleased and to noted we rate continue rheumatologists. peak of expect overall XXX,XXX look And accelerate, We're the to high We population XX%, force and penetration that that that as my continued have grow. in growing nephrologists that continues by small sales expectations, across sales penetration, as nephrology towards I we're really our we to both

written around it noted predominantly further physicians not over came year. We new had growth of who So quarter in the penetration, in physicians. a quarter percentage who hadn't people further read from the driving significant KRYSTEXXA KRYSTEXXA and it's a in

us really that a long-term From care the managed excited what the as remains last several years. confidence. situation potential over the that's So with discussed gave we're we've about TEPEZZA, and

and the drove was driving was levels. That have what overall coverage. around very focused what We and good initially studied approval. CAS CAS on That we

CAS level than of CAS X. majority the greater of some So some with having a of than greater X lives have

in getting in old high the the we're have way diplopia, when at talk And penetration Phase what chronic point looking to continue chronic change this we business who did at eye getting, proptosis those also We're not would is have of as in are When of seen be and score. patients acute look time. the activity disease, we look a getting and with match We at evolution patients at up III. time-based. this about currently and clinical -- of we both clinical the high acute you we our program that policies not treatment coverage significant of thyroid

through payer test policy reads the scores, to clinical who requirements our what and patients, to from business -- is into of which the within chronic significantly expectation chronic is similar our CAS study, of description low coming criteria So penetration is significant III that, activity enable that high our have to have the and move proceeds program. patients your broader majority to acute to Phase that And that population.

please. next Chris, Jason. Thanks, question,

of Cowen will from Ken Our Company, next come and Cacciatore LLC. question

see here, Good good progress to it.

us had the TEPEZZA, remaining And accelerate to the you we here X,XXX clinicians you explanation past percentage you can of surgeons been surgeons surgeons ocular ocular the great percentage and that have baseline to those give they about as set have talked look gains that a kind nuance, Just we cover? quarter, slower with quarterly and been wondering early give in you're of doing then maybe others that that into can what those if you've then could patients you And specialists top why at continue embraced about you've can it. if about or sense these such Tim, maybe adopters, group success the a that do talk adopted maybe talk to to Can of want a best really added? of help ocular product. you the and in have what get TEPEZZA,

uptake reimbursement accelerating certainly benefit what specialists were really of and of adopted the Ocular specialist the our dramatic So that the that. TEPEZZA think risk the the and I into. led that thank ones to the saw behind appreciate tremendous exposure early to adopters is some I Ken. led us ocular we early were with And launch challenges you, TEPEZZA key question. to that went And and that

a single And possible. ocular organization, of process TEPEZZA, services So situation our streamline office talked capability they on patients the have my my and with or for hit about patient each about XX is smooth manage and to as run how would on into that as offices process that staff to respective make contact specialists, where what around reimbursement if that's wall. point XX focusing we've lot or a I and working XX educate to

really our focus is. that's where So

sales required extended for into us to what's expanded office, and less patients to that that treated grow about within force of XX,XXX uptake. I continue talked, what that about getting And drive and XX,XXX to specialist, XX% initial that is have seen continue think primarily our uptake. to are than as the audience broader is being endocrinology drove ophthalmology we there’s ocular and really

Great. next Thanks, Chris, Ken. question.

will of David Securities Risinger SVB come question next The from LLC.

much all very congrats and on Thanks the progress.

X TEPEZZA fourth breadth what's and required growth you are, sequential my questions sales could the launch including So color TEPEZZA that discuss on expected countries drug to plan to orphan provide obtain the you one, could second, in? the discuss you and number for Europe, quarter, potential pulls? in pushes including designation in And of more the

and after over we chronic So expectation will key for expect going both continued I is of designation. comments, as we few our today as into TEPEZZA force. that we've sales and DTC, drug with market not that to through and peer-to-peer going my our as out do sales orphan the last modest be effectiveness the came we program at Europe, an we've designation drug we our growth, be and a sequential expect quarters, growth. what that's as and over discussed been look the to growth, acute by not expect, the several going in we to as driven expect orphan led XXXX, in mid-double-digit months process we least programs, through noted last our number going Europe, expanded of the Relative in And do principally us penetration and well

So thank you, Dave.

question, Chris, Thanks, Dave. please. next

Companies. Sandler come David from will question next The Amsellem of Piper

TEPEZZA, topic I think in high on going that. Because you're big of Europe. was changed? What the in following a a of part up On One on whether caution regarding just past, sounded on there one pricing dazo. go of to TEPEZZA, you the level and

one. Maybe subgroup a a know the or than to specifically there you'll can then already to X have symptoms, what have something systemic a you get might But over us So Is drug, do help see X signal less? wondering in and what about on there of number dazo, other? there. understand of or you average what would we signal that the you the have what believe similar disease. U.S., regarding on your I'm versus know just mechanistically based I piece data. you about on kind anything relative localized do And on better think that's pricing lend dazo better the that disease question changed expectations localized we you think something

a Nothing drug has last approaches our quarter initial and which that population, through around as David. opportunity, Thanks, -- TEPEZZA focused and have and orphan we was Sure. we designation EMA with that see did from would not went pricing changed where valuable. we with the volume get acute being

much patients. TED subsequently we market, chronic a be trials, total And XX data Europe. significant opportunity be waiting with TEPEZZA Europe in different broader we'll so opportunity we ineligible in benefit looked population, at the broader that patient biggest is investigator-initiative reevaluated so specific, significant we incidence to have fact saw And the to number patients from go of data move We similar and in lower-CAS And set. broader chronic the TEPEZZA about have the the and have of that a a difference into prevalence. to benefit had for the opportunity, we that forward combined given volume showing that confidence

our plan that's So is where focused.

And really -- question the

why Liz, talk about you please? For dazodalibep, don't

Certainly.

at So for dazodalibep, as we Sjögren''s syndrome. look

the salivary also to kidneys, that we benefit well the really sort but seen relevant glands to as dryness. are for we patients is I'll what that sure, severe of systemic CDXX primarily there. as numerical in on defining systemic relevant localized for see data tissues which So those be symptoms, dryness we course, for more we relevant are the with their places suggests that that disease on both the joint moderate improvements And and like note already know that going also in localized population. symptoms, expression have of saw population that is systemic feature. the And for trial,

of to out that what may our see support the and we about optimism year. further but comes data population, see next we'll wait helps out this So have

relevant the point the in as both So be that significant we've with consider have that good even so to population, both think But market data would systemic of be and unmet populations. mechanistic one suggests view reason well is think, as that attractive I certainly, might overall, opportunity. we need we far had I it from the an

Thanks, Liz. please. question, next Operator,

Equity Our come will Research. from question next Nachman of BMO Markets Capital Gary

larger data is the you TEPEZZA, certain in on release low about fully if of now enrolled, the in quarter first that at at expectations that show since efforts? considering on second that that your the will chronic thinking point? would think own it's secondly, efficacy So XX on markets commercialize year, So large Is the this then have your that expand sufficient? interesting to does QXX study, sales the it's your that just the what additional that's maximize for Bio need And derm. Or deal, should you BD opportunity, in magnitude you're a And pretty low-CAS category, studies? you CAS? shift one. open-label you when all it's the data in next we atopic showed to you the that a a to reps category are positive, force relative exploring you Is to of see do

planned a you was QXX, want to that approach QXX, specifically? speak do with Well, with Andy,

we've meaningful that a about a mechanism signal how IL-XR. through we going QXX on dermatitis in also so exploring forward on axis take we're trial. autoimmune what on We're X shared of of atopic another we variety understand And the think on is was to the we've efficacy, diseases. In looking candidate QXX get to that can pursue. as we're in of path of to And both that here this a of particularly read agreed atopic the better dermatitis, excited potential to Yes. them collaboration, the of studies out embarking and those the indication of already get with

terms In with what on the data do then at we we'll we that of option, if the exercise if how the point proceed we development. like we based and following decide that, data

to to it XXX,XXX population. we and expand the And force built powering all based patient was then the into first do I'll how part the getting eligible take the we pass initial our to with speak chronic over that at look the TEPEZZA, on to -- the of and and We work relative data, to chronic did. expect analysis sales for Liz not

not an is point at time. that this So expectation in Liz?

Sure.

payer wanted in to way So perspective. a were to as proptosis is be have we trial TED a activity patient that higher to as from their What meaningful would trial, population that clinical so clinically we improvement together on chronic physician putting that patient, going and such the well we patients and make demonstrate really we in informative a show patients the about meaningfully trial, at with scores. sure got that if we we thought information be as a generating able we've were meaningful will we've here this that was demonstrated to that improvement looked a improved had able proptosis successful in we have

Operator, for more tend please. question, Liz. Thanks, X

LLC. last question will The of Tewari come Jefferies Akash from

for on is This Amy Akash.

in reimbursement/access basis agents, TED change risk ready lower, force could and any we expansion the implies hit? to finally, love proptosis of Is see there? then where would It color your one sales versus some ramp how need QX And the on baseline in that you of an to expect there if be versus XXX low-CAS your And QX? patient TEPEZZA a and these trending QX for net us of like on do on reps a can to go only then know true So the force breakdown be TEPEZZA in Between you the adds flat first study, sort a you a baseline total this? that could score by proptosis will increase reps we price of give could sales many end many could XXXX TEPEZZA. active? sales on uptake up, third quarter lower proptosis be guide are blinded QX? at of seems taking your How chronic

don't include the the The organization. about of and bunch parts of a our reps we questions. talked sales are So numbers other

we growth. the low to about do Liz, baseline expect entry sequential fourth talk and our guidance, quarter CAS modest And criteria? For want you

that constructed comment baseline we we adequate amount this just would of proptosis there. I'll a an from be Yes. able have to abnormal improvement have ensure that show patients ensure meaningful to trial to that

approximately Thank morning. Liz. you. of Thanks, And webcast Yes. Great. in our available and be replay Thanks, X concludes call call Chris. That A will hours. this this

call. conference today's you for participating. all concludes Thank This

day. You disconnect, may pleasant and now have a