HZNP - Earnings call transcript Q4 2021 | Horizon Therapeutics Public Ltd Co

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

Operator

Good morning, and thank you for standing by. Welcome to the Horizon Therapeutics Fourth Quarter and Full Year 2021 Earnings Conference Call.

As a reminder, today's conference call is being recorded. I would now like to introduce Ms. Tina Ventura, Senior Vice President and Investor Relations Officer.

Tina Ventura

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

Executive today call. Walbert, Liz be Andy Chairman, On Paul Executive the and and Pasternak, will Tim Cox, me with Hoelscher, Development; Chief and Officer; call Executive President Vice Financial Strategy Aaron are Chief Executive President, Vice Research transitioning President, Finance. President, Vice Chief Vice Officer; Officer; Thompson, Aaron year to Executive President, fourth Tim Liz our CFO quarter will our our full take first business, discuss our review by quarter the then guidance financial and followed performance closing After your Tim, Paul, performance. remarks detail. will review will we'll including programs, questions. and after R&D more from in who

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

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

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

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

Tim Walbert

again the we performance. delivered financial [Technical Tina. Thank Difficulty] once At time, you, top-tier same

adjusted of and $X.X of $X.X our sales increased net full increased billion total year nearly full XX%. XX%, EBITDA year Our

represents more operating our very This $X a than we again strong financial XXXX cash We issued flow. guidance at growth midpoint. in that generated the also full year morning, billion

to $X.X represents sales year $X of billion full Our net billion guidance XX% growth.

points of XX% billion margin of basis and billion expansion. to growth guidance XXX EBITDA adjusted $X.X $X.XX represents Our

Importantly, to we which than drive commercial performance increased should margin to investments our in continue more R&D. significant the we expect make accretion, offset

look across strategic best expanding In maximizing in expertise. peers, and building significantly biotech tremendous on medicines our expanding deepening our growth our pipeline Viela one and we industry. As cap commercial scientific XXXX, pipeline, globally. We profile profitable we of progress is goals, large our R&D made the the Horizon's acquired our and

net Our programs, XX in molecules beginning to plan pipeline initiate with new the majority next we with year, more We quarter. that now areata than Notably, identified in indications portfolio. this work trials to our added alopecia the daxdilimab XXXX. we X maximize includes in for trial with XX%, to KRYSTEXXA we We sales to by believe increased true multibillion-dollar year in more daxdilimab post TEPEZZA has XX-year-old second remarkable Commercially, launch the a pipeline and than product a for doubled a a its potential net be in nearly medicine. potential. sales

repositioned, the UPLIZNA relaunched also it in months just and X acquiring rebranded Viela. We after with

than path net This sales outside peak Japan. we TED week, trial puts of We second last the with launch $XXX U.S. in the continue global the to for journey European the in international change in infrastructure the on people us TEPEZZA annual build in potential patient evaluating Europe, in required our the support to million. first the enrolled assuming approval. first treatment announced is Commission to a including of TEPEZZA clinical quarter, presence, and in reaching our UPLIZNA step And expectations for more our

serve. lives of Behind a demand. the manufacturer strategy on difference drug supply in are second to We a We all in capacity dedication to people product of biologic drug TEPEZZA added our the efforts manufacturing makes also and expanded facility growing the new significantly Their Ireland. patients we executing meet acquired our product global Horizon. our Waterford,

best to continue the highly company we work number evidenced Fortune's diversity employees X biotech by a received confirmed ranking equity. XXX Horizon We're company the including pharmaceutical to as it ethnicity be accomplishment that in as workplace This XX again equity. in nearly by companies our conducted second engaged XXXX, awards for. Our especially workforce in as is size. Aon values XXXX, doubled achieved gender demonstrates study a once and of meaningful pay In while was also

$X.XX of COVID-XX quarter growth quarter fourth fourth results. million, of performance our net year-over-year XX%. of therapy TEPEZZA quickly, the strong sales government-mandated to TEPEZZA out forms. our on year year end Full this incredibly supply full expectations. representing despite April and commercial were resuming strong converting that continued impact new relaunch the following We $XXX were of We executed Moving disruption, on of the market patients through enrollment and billion, new a sales patient from exceeding year achieved disruption driving XXXX patients full the and took this year. last

in We patient this trial also a chronic initiated randomized TED drive in population. uptake help to further placebo-controlled

continue the enter we drive and adoption year TEPEZZA. to growth we our market, PEP third As of in strong

We are of to next commercial from many patients significant and see more help the TEPEZZA. potential our focused benefit on stage strategy

TED We're our proportion First, our their those messaging surgeons refining patients. and job today. on business acoplastic build improving date resonates X/X only of we an deeply and physician to more We capture each success to prescribing targets we to higher with see with targeting plan and specialists those best more a what about neuro physicians to specialty. ophthalmologists. physicians done of incredible penetrate physician our as and our high-priority opportunity We've significant for TEPEZZA learn

vision. a TED of neuro-ophthalmologists as focus For example, on diplopia symptoms such or main focus the proptosis reduction of surgeons double is set signs and oculoplastic for broader while more

patients with are patients. a market general TED. the in underlying targeted was there ophthalmologists under Endocrinologists way patient broadening years and no that treat their our lack due and a treat of to for no typically today. of with endocrinologists way. is TED, disease, But general reach the And ago prescriber majority Second, of X and journey. symptoms graves' of therefore, just find this well-defined do ophthalmologists a had patients TEPEZZA awareness not treatment options we underlying to diagnosis to patients Remember,

and working are TED to prescribers. to the should activate educating thousands TEPEZZA referral from benefit is strategy as of those accelerate process We help the patient a and that both journey This longer-term certain improve physicians patients physicians multiyear TEPEZZA.

such Third, the awareness our have We're expand reaching has of we're diplopia continuing significant launched of the TED DTC, the spectrum campaign a TED in proven in new patients. successful focus campaign well. and which investment broad to a as symptoms unbranded as impact evolving

campaign We've TED the than of DTC May and In the our to goal when addition last main patients treatment to strong is in use results continued TED generate doubled from specialist of specialist. campaign branded year. finder of awareness our help the creation, launched find to a we TED more

Our year primary this further commercial to penetrate is the focus TED acute opportunity.

in Additionally, year, TEPEZZA X educate of in the TEPEZZA are last experiences case nearly to TED published now quarter patients. on XX began we physicians series patients. the use fourth with chronic chronic There of successful setting

the towards mid-XXs, Top results XXXX patients of a in data many net KRYSTEXXA, who billion. estimate fourth In today significant clinical line sales XXXX help KRYSTEXXA full year of a medical $XXX medical more to for our trial sales growth placebo. congresses at as of year methotrexate working showed was results and allow of publication among year stood analysis label. start TEPEZZA, immunomodulation patients $X.X January MIRROR or of supplemental drive expect will present chronic quarter is to MIRROR is anticipate sales global at application the of year. This by net promote driving the in this our trial for KRYSTEXXA KRYSTEXXA improvement XX% driving year additional outstanding In MIRROR XX% peak the now meantime, of physicians of patients, we a higher only inflammation. point on for net response. submitted safety physicians. be from publish conviction than advance acute KRYSTEXXA could this the XXXX. plus percentage XX% clinical in results more We sales With and new proactively for patients their full another treating team growth This compared XX and reported on patients would a complete TEPEZZA up annual where with FDA our and as trial with high Approval million. plus more are conviction at well approaching KRYSTEXXA than $XXX data growth the prescribe and representing trial physicians. net barriers commercial affairs license is including next estimate randomized year-over-year controlled to of to a clinical percentage year throughout payers is immunomodulation to we year, strategy. which clinical XX% than controlled continue teams our we U.S. as the for from the subsequent new Immunomodulation data to biologics the plus incorporate methotrexate trial, journals from randomized million, remove We patients peer-reviewed Those year-end. we into to

that working. expand as strong prescribed our year is well who has strategy prescriber growth prescribers We have as evidence that immunomodulation continue the new a to significant with base physicians KRYSTEXXA in over in

put the attribute doubling progress nephrology XXXX. Nephrology last place in XX% segment sales growth pepsin Our year. dedicated reflects prescribers, rapidly been team compared increased the growing XXXX. which to We XXXX nearly in we we're has with nephrology successful seeing This continued to versus the

invest As our billion, annual rheumatology to urgency achieve than infusion to expect estimate strong standard $X the and more to and trials. our gout to our areas monthly another nephrology, on we and supported elevate core XX%. is specialty patients immunomodulation look strategy of track XXXX, improve including uncontrolled redefine of treat than We're year, our of projecting dosing by short utilization net the to sales the KRYSTEXXA expand to growth duration plus sales of care experience, in patient to we and is net which more peak

quarter. and year, Approximately in UPLIZNA. beginning to This medicines. our compared and Viela see acquisition awareness to UPLIZNA, a of put strategy our full Moving our among neuroimmunology million patients We revenue rare successfully quickly $X fourth net where relationships quarter from We're is market million. patient-centric research infrastructure our that fourth deep increased Along partner. to in this place results. TEPEZZA, relaunch team and $XX we we right and prelaunch. our sales UPLIZNA conducted survey we the period evidenced Japanese international of approach was We the for conduct team knowledge. UPLIZNA relaunched of a the to significantly and market We the medicine, before earlier experience, physicians work disease by with to KRYSTEXXA the of our and build leveraging generated of develop use

our of expanded with the our the force. programs expanded more from activity In speaker fourth third call in the a We patient doubled half in enrollment addition, significantly indicative sales than peer-to-peer generated compared reach to prescribers fourth physician than and more of XX% the the of third, from our new coming increase forms prescribers. in total quarter quarter extended

new Germany of progress confident substantial result support made the we increasingly We're launch UPLIZNA prospects PEP our quarter-over-quarter in beginning in with a potential medicine capabilities approval. infrastructure this assuming Europe second in XXXX, pursuing. this As quarter, we growth patient the indications most and we starts. for to in and Internationally, year, are other generated the of in European Commission the efforts, strong in building

across I'll another all over growth UPLIZNA. sales XXXX in as our expect Liz an strong our net We peak we expectations, billion global of progress the on progress in call to for towards update turn than more R&D. indications now for year $X very

Elizabeth Thompson

through growth update morning, partnerships as our a on and daxdilimab, expansion into and expanded State-of-the-Art In therapeutic And high-quality Coast progress and our I'll years dermatology facility internal drive of our serve key coming made our continued I new areas, announced We programs including XXXX. the hub. new R&D primary with in collaborations. INDs expect the function as as East Maryland our neuroimmunology, cells as or further long-term XXXX, We well R&D, and and our support collaborations. the or with in transformational you Thank cell first Daxdilimab acquisition for own starting and we we of X This progress progress found programs, announced XXXX. the inflammatory plasma growth. through in internal respiratory. and high development. PDCs the HZN significantly engine morning, plan out can and external in through new clinical discovery diseases, of to over is began inflammation our added X efforts and cytogendritic these we tissue only building significant research PDC in generate certain tissues programs everyone. X year we to the disease through preclinical organization of We autoimmune a result was Tim, concentrations in good pipeline damage. and the through you, and of the we are XXXX activity depleter to individuals move Viela,

Our lupus systemic is daxdilimab trial SLE, erythematosus, underway. in or

We begin trials year. indications this to additional expect clinical in X

approved the areata, of alopecia are the primary more our approximately an be be hair no or the hair of candidates efficacy. quarter loss. trial alopecia or for which nonscarring initiate in to commonly lupus patients We're level are often open-label alopecia measure disfiguring. from loss. by used most is result severe It patients effects trial that tool, a side would and to first, in of disease. score with Week percent medicines disease, DLE, is also significantly autoimmune therapies is characterized currently our The the patients. score U.S. with II appropriate disorder disease biologics. second We can patients severity in disease moderate SALT with change off-label than We XX. by this Phase a XXX,XXX discoid from areata plan at trial scarifying XX,XXX There treated endpoint SALT, variable to can of severity in in on in DLE initiate in is and the erythematosus, baseline the to track XX significant suffer the approximately The midyear. estimate

expect the severe in to inflammatory initiate children in affect third and muscle trial kidney very trial a nephritis, fourth quarter. way. condition We we rare in And dermatomyositis weakness lupus condition quarter. the a our rash a expect finally, our an to initiate that This severe is the manifests and in in of can autoimmune debilitate skin

in Moving quarter Phase antagonist for HZN in transplant pathway trial and diseases. in on This kidney expect second a by dazodalibep, inflammatory and Dazodalibep rejection. our rheumatoid year, year-end. This transplant currently many designed CDXX II II arthritis to involved X Phase autoimmune or XXXX. block and kidney Sjogren’s ligand syndrome, rheumatoid is rejection central we arthritis trials readouts, the is

understood a arthritis ligand rheumatoid to opportunity using the CDXX about our accelerate trial dazodalibep in Our points. pathway gives well clinical accessible a and population rheumatoid is learning large reasonably our us initial end arthritis, in and relevant CDXX, Phase expand decisions impact disease. regimens, I on pathway dosing In mechanism trial, results also our we our under the the understanding can suggest impact of a this this dosing which can other inhibiting profile potential can indications. of various inform in

FSGS dazodalibep We in kidney expect trial the in the to disease, progressive initiate our quarter. rare fourth and

brainstem. neuro X to indicated nerve, fibrosis oral year. Moving fibrotic antagonist, has Phase disease. for pulmonary anti-CDXX of this and idiopathic and rare HZN-XXX in LPARX in disease and diffuse November a in our which in our cord systemic in the our recently devastating monoclonal our first UPLIZNA of humanized We trials antibody January is optic enrolled clinical attacks spinal inflammatory NMOSD, impact for in that autoimmune HZN-XXX, signs pivotal cutaneous patients IIb early sclerosis selective shown

to North efficacy safety literature UPLIZNA. new NANOS. Most February, the of the and Neuro to or Ophthalmology contribute data presented continue American Society at we regarding in profile recently, the Meeting, We

the of In the analysis demonstrated time with treatment first severity attack already attacks. new addition reduced to also increasing benefit UPLIZNA for NMOSD, to the with this patients suggested on that living

evaluating and UPLIZNA disease. for trials our IgGX-related III We continue advance to Phase myasthenia gravis

patients data we TEPEZZA in with our the in results and literature of now to see eye and will Moving TEPEZZA. chronic add We're trial this enroll randomized emerging the role The continuing placebo-controlled TEPEZZA TED. in to in continue additional TED. regarding to analysis thyroid disease. chronic patients trial treatment its of studying Meanwhile, IV Phase to

meta-analysis with recently steroids. treating adjusted clinically of are comparisons diplopia and we're IV IV with the we pronisolone is impactful example, not same diplopia. manuscript, a in steroids, some and of for supported and TEPEZZA on and For effective In have that show intravenous not that matching for metal comparison steroids TEPEZZA TED. time indirect and published relevant in the or for most compared improvements consistent proptosis seeing some IV steroids greater of with changes symptoms This what small, proptosis known cross-trial funds only

our and where concentration We multiple subcutaneous approaches the a program, TEPEZZA Halozyme technology. with also Options include we new high formulation. continue without to under consideration are administration options advance exploring with

We different doses, and have single safety, completed the pleased a Phase of with pharmacokinetics I trial we X healthy In were single we formulation. in current this our dosing and trial, volunteers the with response. tolerability subcu assess

initiate Next, we're patients midyear. and study moving Phase to in Ib formulation to test this TED expect this

The TED III baseline will formulation and and and as the work United of The And the was clinical include with and results in Japanese severe we concentration expect trial. based by XX endpoint TED. with from is work by of States pivotal our The to trial later year. last in in we least Japanese Europe. trial authority proptosis begin announced in eye. X-millimeter high our regimen, will dose We in rate our moderate to trial a approximately evaluate the week, the initiated this at on which then measured a participants conducted study in XX clinical experts trial in proptosis define Japan. reduction The Week a with OPTIC primary with help the regulatory we the this Phase designed informed experience will percentage at active responder patients discussions

in to with ways to trial, our ACR for shorter and monthly improving fall. as of referenced improve the forward substantial meetings evaluating look its the trial continue XXXX. KRYSTEXXA, details and on to additional We've duration trial to dosing. MIRROR midyear we results and profile Tim the infusion expect progress efficacy made explore sharing our We working at we profile improve second medical key where patients. in the KRYSTEXXA such with ULAR half its And

Beyond our to preclinical call these the and busy such new with efforts programs. Hemosphere the approaches and ahead. of underlying target In I'll that Arrowhead over turn expect with we now KRYSTEXXA, gout investing another we're as productive cause Paul. year summary,

Paul Hoelscher

total morning XXXX. focus guidance Thanks, on net $X results, year key a XXXX. to growth otherwise our our billion, quarter primarily strong results, performances of will with This our closed year-over-year start Liz. compared comments full followed XX% with XX%, year of fourth billion, quarter by nearly TEPEZZA record and sales sales representing drivers, will driven My growth were KRYSTEXXA. of the for this growth our financial out by non-GAAP I $X.X unless net Fourth noted.

Orphan Our of $XXX was net increase income of for segment year-over-year $XX sales $XXX the segment with fourth a generated million. income quarter sales XX%. million. million, Orphan Net were segment $XX Inflammation segment of operating million, operating

to continue We flow in our cash maximizing drivers generated reinvest pipeline. this focus expanding from segment to the and growth on our

for Our net in non-GAAP fourth Fourth XX.X% $XXX full profit the expenses sales. was $XXX or of non-GAAP million This included million. XX.X% quarter year. gross were ratio R&D of non-GAAP and quarter the XX% operating expense

we financial milestone non-GAAP agreements we in exclude measures. and from related longer our December, no license and collaboration noted payments As to upfront

R&D expense So in of includes payments. million upfront the fourth $XX milestone quarter approximately and

million expense includes full R&D the approximately non-GAAP $XX which upfront was milestone and year, of payments. our For million, $XXX

fourth representing million XX%. year-over-year for net sales, full SG&A expense non-GAAP year. and Our the $XXX $X.X quarter EBITDA growth million was of in XX% was of the or billion adjusted Fourth $XXX quarter

The rate for non-GAAP were approximately $X.XX. adjusted our or year non-GAAP quarter was the year quarter Non-GAAP to billion growth million was of the share tax non-GAAP per net diluted fourth was Our fourth EBITDA rate for and X.X%. full XX.X%, representing net bringing $XXX earnings of XX%. XX% full income tax $X.X sales,

quarter non-GAAP shares The year and billion, weighted full full $X.XX million to used earnings calculate full non-GAAP shares EPS shares, operating XXX cash non-GAAP million average $XXX share respectively. year fourth and million XXXX per and Fourth diluted XXX diluted year and were respectively. outstanding flows $X.XX. were Our quarter were

were and $X.XX billion. December XX, As of equivalents Cash cash

is expected business XXXX. in billion, $X.X of flows, debt role a the with The earliest principal outstanding cash to cash our continue critical position our total and future pipeline. strong in development the With maturity expanding play will amount

of XX Xx. months XX, last our adjusted As gross was debt to leverage December ratio EBITDA

X.Xx. Our $X net net debt leverage debt last was of a adjusted EBITDA resulting in billion, ratio to XX-month

outlook morning, midpoint. year-over-year billion on full growth This to net we XXXX. XXXX for our to guidance of year Moving $X.X representing sales $X the now of XX% billion, provided at

the expect in net TEPEZZA, year full growth For XXXX percentage sales we mid-XXs.

we For more XX%. net of full than XXXX year expect growth KRYSTEXXA, sales

We expect margin gross full year of approximately XX%. XXXX

the We first margin to expect quarter. our gross be highest in the

to adjusted the XX% As TEPEZZA percentage we billion, through year, basis we Full margin we the a as XXX EBITDA expansion we mid margin compared XXXX. gross $X.X is $X.XX to royalties the expected pay. higher billion tiers be progress reach a year at point, to on expect decrease point representing to

strong expectations in in our Our as net to digits percentage by EBITDA we a adjusted the expect offset investment for sales, of increased R&D, our low guidance reflects growth be which sales. in partially double net

commercial to increased than We significant our this margin will expect accretion, offset more performance investment. which drive

of As increase the the we XXXX course expect think over expense, about our year. a we operating steady

the non-GAAP fourth Excluding approximately expenses of payments from milestone $XXX XXXX, quarter were R&D-related million. operating the

would from modest quarter-over-quarter mainly XXXX, there, For expect by R&D. we a driven increase

be $XX We interest year non-GAAP expect our to to approximately million. $XX million expense full net

to year rate We full XX%. expect our non-GAAP approach tax

we tax digits. on make could any in that We to change And estimate rates rate will may anticipate as result or year, divestitures our acquisitions or tax every as tax quarterly As rate laws. single high variability in our of be changes our significantly basis. with always, a non-GAAP the in we mid- tax cash a

first count weighted approximately expect share the year let XXXX on touch be And We me XXX full finally, shares. million to quarter. our average diluted

year, impacted coverage. and we resets As experience every first their of deductible the seasonality co-pay quarter are sales by to care and changes other see expected patients our in year, as the lowest net be health

the omicron on year from and to infusion scheduled this an variant in delays saw offices also COVID-XX due earlier We both KRYSTEXXA. TEPEZZA impact and

to his typical year expect mid-teens the net this in a sales in and expectations. down fourth from the year that, for trajectory concluding good about Therefore, I'll since remarks. quarter of turn to a have the call the step our quarter nice We XXXX full uptick then the Tim in seen XXXX. first of With we feel over

Tim Walbert

Paul. our XXXX well as another strategic most Horizon by record importantly, pipeline. expansion financial outstanding commercial goals, of year as our you, progress supported accelerated execution Thank strong with was for results on the

initiate of new clinical this to trials expect year, have which X X started. We recently

we pipeline As growth see of future, annual look for the to to candidates. we peak our potential $XX approximately for sales current net along a billion our with drivers combined TEPEZZA

year We expect another standout performance.

year large that, profiles flexibility XXXX full billion Our pipeline. guidance With support among $X.X development With expand than we'll cash, represents have to to call one our our of open growth more of questions. the the further best we peers. our to biotech profitable cap significant up activities business

Tina Ventura

you begin. can Olivia,

Operator

[Operator Instructions] Annabel first question from Samimy with coming line the Stifel. Our of

Annabel Samimy

longer factor than I rate the think Can guidance? biotech a or comfortable patients year? specific or the treating? you tailwinds this current refractory they And does have physicians you the data that on or TEPEZZA, far payments are first in issue is label way Have into trading about as argument to changing I characterize longer impact headwinds into guess, disease there of the us the included fourth you by talk terms Are what Optitex quarter. mid-XXs how treatment had such Because any more were, starting So to big launch. patients? as typical that might customize so for

of -- the just infrastructure Any -- of to new academic that to looks bit And starting begin your community? patients going you're any UPLIZNA, color on share color little a there. to on like versus that informed of metrics provide switches like contribution is can who's can versus wanted what a physician like then kind we are a have there. So nice I you Just to how treating, more patient it impact. UPLIZNA outside just maybe treating patients enrollment types get

Tina Ventura

do relaunch recently to plus part want about Annabel that on published OPTIC-X and start a in Liz, was of asked with of data of the some in perhaps thoughts then Tim, Great. as the that. you I that our think some

Tim Walbert

Okay. Sure.

strong UPLIZNA, the with seen the we initial So as in we've a prepared start. said remarks,

our sales put pre in we quarter. since places, awareness fourth increased from the has significantly Importantly, force

so pleased with to this and continue tracking year. So are be things far the where uptake

So from and plasma. that we'll we'll continue I to progress, the how Liz a continued expect to high-level into assume with the growth standpoint throughout are progressing sequential and taps get And year report see OPTIC-X? with

Elizabeth Thompson

Yes.

were published, some meetings. we longer recently in at of patients OPTIC-X of strong trial, really are the that had data a III Phase findings exactly those previously see I you compared the even right shared And with disease medical that you're think OPTIC-X original our data duration the great with results. So good out do

place we support So has this that of relevant think in being this the a And real were to think Phase to this for we continues swath confirm is strict trial, for good broader for have. patients with role therapy a that in label put the criteria that III TEPEZZA beyond I patients. are consistent the broad

Annabel Samimy

you us of just percent can what tell And now? chronic the

Tim Walbert

enrollment look population, and launch that place on focused us policies chronic why our And the population. it's of that's for that And patients, put now we And of the is and overall in patients will TEPEZZA fitting percent the to important than mid-teens CAS CAS, the activity so on scores we've clinical those in of as results the been so are score in the at be with that we criteria less this acute we our chronic through greater when right year we towards remain the being than as low that we trial through end as there expect can benefit in get move of We're X So greater high really year. the focused chronic a looked to continue penetration is than Q. X, as certainly at there. X. CAS really chronic with the patients to it's chronic, see in

but et activity clinical So symptoms and cetera. pain, other high scores, diplopia like end low

So results overall year. really these mid-teens of the looking forward this to pleased patients and with really percentage

Tina Ventura

Annabel. question. Operator, Thanks, next

Operator

JPMorgan. from Chris question coming Schott line of the with next Our

Chris Schott

Or the this more on focus a there community? a ophthalmologists of on KOLs? Just is trying an TEPEZZA. group study Is the in expanding volumes just Is maybe was study kind guess you TEPEZZA bit a core more referrals prescribing in opportunity? of the or comments, opportunity you the in Or more expanding to that guidance? chronic general beyond increasing had the XXXX traction a third quarterly and kind prescribers on is just a reporting terms just sense commercial from correct of initial there few have little of XXXX out but increase the KOL still I'm comment. Tim, about of breadth here. on factor clarifying there? about question or get just it's that the the the during of one assuming year. breadth on the just now those more second success, that out know is then touched of And I within and tapped I gating into and terms core this I

I TEPEZZA just Does think confusion? there's you comment down well, to apply that no said sequential in mid-teens step as sales.

Tim Walbert

our has and the applies over consistent across X been last medicines. X, It does. It years

investigator-initiated higher the chronic chronic XX So CAS of TEPEZZA, standpoint, have in apply patients scores of we the population. trial. Chris. data A lot to from them it have does From a

beyond year majority will important published. those in this the be results as that So 'XX of end that we and the one chronic the placebo-controlled and in impact is most toward get our getting trial of

look of X,XXX call targets. we are have TEPEZZA top of of those those our specialists, you priority high those TEPEZZA, And total As so X/X prescribed are X,XXX, you them, X,XXX, do on surgeons called about ophthalmologists business ocuplastic we X/X if prescribers, TEPEZZA. targets about look and only have about so priority numbers, and neuro X/X or rough it, your those at about at for the when --

to So and there a targets in is chronic effort our significant broader of the business acute in force And universe. those opportunity that's standpoint. primary to continue that focus sales that to penetrate prescribing from high-priority get much

to expect in mid-teens. We to the focus, maintain continue we and that

Tina Ventura

Thanks, Chris. Olivia, next question, please.

Operator

line the David from coming Amsellem question next Piper Sandler. of Our with

David Amsellem

a couple. with start just I'll So UPLIZNA.

you starts just getting patients? secondly being seeing sequentially, said, immunosuppressants? an know some in that of how chunk that that uptick or but sourcing given daxdilimab. the can you're from was from switching patients rituximab older are then are a in on So of product coming to away -- new growth you on talk So with I mind, of And ex-U.S., you that good

your have So your nephritis a SLE, to think an regarding some could overarching to have thoughts a wide this casting discoid, you higher you somewhat to that in depleter thought And seems is the net talked about do you the have process wanted discoid. and PDC It where best for lupus. enthusiasm of product get we've question read as sort a KOLs there. I but signal and amongst about lupus specifically,

Tim Walbert

I'll and Liz PDC take the first, then about our daxdilimab, depleter. can

we've strong So as sequential you growth. noted, had

but that we're was treatment to the also with we new as we are with both. quarter, relaunch sourcing from this the patients and NMOSD, would fourth of rituximab. we're progress see novo continue in quarter moved patients far first as into getting we're The getting getting switching very to I primarily say And that. de pleased from patients, -- year. We're as

So with treatment I sourcing with Liz? say prior equal it's patients both percentage patients new from and rituximab. would about

Elizabeth Thompson

say, respect to related a as in a daxdilimab, is lupus different and looking on indications, lupus you which We're So our real exactly with XXXX, focus depletor. with indications. PDC but number of at

we lupus the those. it's in about that's As SLE overlap nephritis, think have choice we helping right in important between for the given think their and We to be to patients. that important going think physicians it, make data

nephritis cover dermatomyositis say SLE good expanded There's to rationale in there same I'll be about little Pleased So for really and as to the bit well. impact in from a you're enthusiasm a to we that's are potential well. that part mechanistic of to the expand that X DLE, hearing of that why as kind hear these we places. lupus

we're alopecia it's got not specifically So about we we should are also lupus launching We've our enthused note while might good pretty see within the here. that bucket, there. I what And study. rationale

get can quick to efficient and are design a so here We an answer possibility about looking efficient at also study is we in what alopecia. the here

for to updating all pretty XXXX, excited of So as and overall, keep that lot a I think potential you we're progresses.

Tina Ventura

next Olivia, question David. please. Thanks,

Operator

coming line Goldman of Kumar Our Madhu with Sachs. next question the from

Madhu Kumar

Yes.

that And about guess where that prescribers kind the broader and where how new you takes So us among towards of where call? think then you supplementary you the approval itself in you earlier more peak guidance, number with trajectory in on kind puts the of sales like of versus on think peak color and number? -- sales TEPEZZA the potentially on give reimbursement do can of uptake be immunomodulators? terms combining there impact mentioned kind could the KRYSTEXXA, And kind on about have KRYSTEXXA on BLA I of could

Tim Walbert

Sure.

place. I with see So we how in remain other it It's been how biologics. expect and reimbursement, and to hurdles TEPEZZA KRYSTEXXA it's on typically and

As if in a the I that have acute answer has well in mentioned are we high for launch. in chronic, fits chronic that policies place doing that because you the put a with over getting population prior around were in very

drive the move continue That's drive to results critical begin that sales as plus the that methotrexate the KRYSTEXXA, is with roll to KRYSTEXXA give on in XXXX. current based MIRROR to so think greater we move force time, this KRYSTEXXA of trial. track the what to to why organization $X actively thing be see results our expect hit plus on do sales to What So as drives I business And and than I chronic into billion, first the the case, able supplemental promote it for we With it. can our upside. it's to to of we that's and the don't I of we're opportunity immunomodulation. -- critical that And as business. we and our peak see the is exceed commercial to get study so critically that BLA

data, including the growth that fourth label, look a And to and you time in 'XX promote. beyond. have up the of So strong in us for lines would getting standard if flexibility set at the quarter really approval

Tina Ventura

Olivia, Madhu. question please. Thanks, Great. next

Operator

Ken question coming Cowen. of next from the Cacciatore Our with line

Ken Cacciatore

know then gave they talk do around about you or the XX%? about, clinician third head even X,XXX. base more Can to need any changing patient talk you And versus steroids? context dynamics population they've for maybe it clinicians on to Can talk they're also treating can I population, maybe current steroids still patient to that the be of getting if and some first put may that maybe out to base you gotten broaden in understand comfortable? try of patients the good remaining Tim, now first? you the are acute little to Or on going the willingness the you're a the into? there's X/X around the TEPEZZA aggressive? of a earlier context the more be capture is Can clinicians bit steroids just XX,XXX to or that addressable XX% just about hold XX,XXX as wanted try past, you

Tim Walbert

Sure.

overall of our not well pace about active with start with X,XXX is high chronic as I'll on call TED we are of targets. vast So all best majority The the in if greater, targets seen by targets. half, and and majority that priority

So mild going opportunity point. earlier in or at physicians We that this see prescribed significant to acute to X/X use. not haven't drive that do

stay what's spontaneously there a small and good done they care will to steroids steroids. acute because is start that phase it's in I remit of that think patients should on number with typically that

other a those and the like become moderate patients symptoms to and the of appropriate treatment have proptosis for pain, TEPEZZA. severe with diplopia get As to patients and number also

moderate And for should penetrate see So we patient but a in that the mild significant be as population, ones penetration, candidates are in we continue TEPEZZA. getting to population. severe I we more that don't would say,

Tina Ventura

Thanks, question please. Ken. next Great. Olivia,

Operator

coming of the Jason Bank Our with next from line of Gerberry question America.

Jason Gerberry

X Just on TEPEZZA.

the First on average annualized pricing. just

that might average past, launch. versus be the of perhaps XX the in about think I been that the some time vials at the talked XX there's commentary was

our it per pricing to And about to could so closer -- up pricing just XX% XXX,XXX wondering push that patient. the assumption, to huge swing factor in

this a of where out. netting figure handle on point So a launch, have you that's guys might at better

So past, if with actively And comment they guys blow few physician you a the probably patients lot engaging of you chronic wondering with treatment because then surgeries options that. these through could in a already. on have of aren't about TED, out run talked their

and Are both you patients sort you that, are Just acute can sort the with of -- your you the track disease, with efforts? So effect forms? both as of of adds fibrotic forms has? DTC the DTC pull-through that curious activating

Tim Walbert

Jason. get is compliance the current sales So full run as clarity didn't that trending first we remains a is about And last had series you're in who months symptoms. on that the at to that of a XX expanding When all patients we trend X our of X symptoms with us months, focused correct, percent it's throughout discussed last XX-plus really into that seen unbranded campaign we've patients on campaign, in about DTC exactly are place. that rate, X years year vials look average associated, and that engaging effort, have XX TED TED have of with certainly we're only nonbranded but and or help

eye their disease specialist DTC areas. out driving in you diplopia those in patients have face commercials double find Obviously is TEPEZZA. there respective identifying look that focused key year on third thyroid at current our last campaign or or from population anywhere to out really television as a vision was go -- among graves pyrite the have patients on and that our them to get graves are seek specialists they our focus symptom rolled and a TEPEZZA And IDC. branded should If on we XX% to may and that may then is early advertising XX% and of that that

a is have. it trying and patients, all to patients is have something patients both high So disease chronic drive early score that lot of or acute and activity active X clinical diplopia that

acute while be would our or responding going those to self-identify of that And typically don't in chronic, as sets symptomology seen after So advertising. patients they're patients. both

chronic. would that clinical higher So have acute populations and speak activity going on, they indicate both would across which

Operator

line Gary of from Our the coming next BMO with question Capital. Nachman

Gary Nachman

way? gone can XXXX there still a through Or last meaningful in next the is for few how a R&D And factored you leverage? from pent-up the driving to what's the more operating issues? do label backlog? guidance? COVID bolus you will level been in completely of do the to drive How have you And into bit wait on improving First that? a target pivot is demand years? TEPEZZA, just spend the has operating that then pipeline, of year lastly, accelerate that So increasing where then over updated the to for more KRYSTEXXA, to the penetration the on nephrology? with even margin What with you Will

Tim Walbert

Sure.

guidance Paul take discussed XXXX. we've can I'll patients times. in We address TEPEZZA, the disruptive in factoring quarter, don't many some see With into that as first our there still X. So fourth operating were the the leverage.

enrollment penetration both XX% mentioned in because KRYSTEXXA would into expect on we patient getting As the and space, think at And patient trial mycophenolate methotrexate, KRYSTEXXA impact and nephrologists. albeit I plus on is nephrology. overall audience. plus label we've KRYSTEXXA, strong focused that in in remarks, rheumatology Within that in used nephrology time. very information much showed penetration this of and is of addition seen the more a we smaller have maximal with RECIPE the certainly forms KRYSTEXXA prescribing growth have growth strong point nephrology, The is prescribing important with of the its I rheumatology by often the the for results mycophenolate

response KRYSTEXXA our background XX% about rate. again, In like kidney PROTECT the majority of transplant that at believe, I which in patients, -- it or them on showed, a immunomodulators, -- looked other most trial, XX% addition, was

you So by is is are that MIRROR And in whereas helped, methotrexate adding further data medicines be to towards leverage? nephrologists the typically of do trial the as want that with really the impacted audience. really the Paul, certainly RECIPE we the of immunomodulation has would that and significantly evidence PROTECT label. get with used address geared rheumatology

Paul Hoelscher

as move we of sales our increase I of expect around as the typical we peak would rare disease towards years. continue we've that move opportunities through of we our higher a to We think year-over-year get we commercial margin to kind as for XX% sales to can medicines. said, And kind future we Sure. different believe leverage as

be impacted that that could additional expect any grow will that towards several the But we bring pipeline could next acquisitions that assets year. over the XX%. year we in impact as years that However, versus by we would do we

Operator

next with Jefferies. coming Our question from the of Tewari Akash line

Akash Tewari

who Halo for subcu Would the you a Or subcu about product need see you long could that are of the reports? formulation of Or in patients time? certain concentration achieve TED the X characteristics of doses don't there administer high mentioned some your you years? with Could potentially XX% maintenance proportion you're we seem today? get formulation patients back chronic setting? rates the terms to term, in TEPEZZA case would to then approach over penetration XX,XXX looking Can what few chronic talk TEPEZZA? to addressable requirement that over with to And to you be next around in respond stepping your XX% well

Tim Walbert

penetration So We next the don't TEPEZZA. in I'll expect XX% take chronic years. XX%, over the X

the modest do Liz, scores high that have are take population. that existing to and that and penetration more with high as that eligible term, chronic expect get year, initially that in you And as data around get As penetrate results we near in the see in placebo-controlled getting acute we beyond. more drive expect cash at able say data. the the acute that than and the X chronic as at we get I look at to trial fit the guidance our $X population, In population. over the we to launch significant being end that the policies XX,XXX billion be expects would we And those population. to the the we're over beyond current time, trial -- place as we 'XX were of cash But greater that? more of we created penetration want chronic

Elizabeth Thompson

Yes.

aiming the we based be not envision given injections include including what do do where using currently That's we're don't at multiple to options, be going and a on towards specifics our clinical at are we looking approaches really find any at that So the we're we're situation going that out regimen to new not to of the Halozyme. dosing program, formulation subcu and looking multiple continue are dosing. high-concentration here. undergoing. said, The what work That in I worked

Tina Ventura

got question, we've we're the please. more of like top coming hour. time looks Operator, Akash. It X the Thanks, to for

Operator

from Michael Martin with the of last our coming question line Ulz And Stanley.

Michael Ulz

in Just some study. that you second time call your later TEPEZZA to me of half in II Phase Maybe seems internal a -- of be we seeing the on for that terms TED sort commentary maybe year-end to one expectations? study It in chronic enrollment as should the would quick be frame? the from of closer of about that the versus opposed expecting on data that you're initial so talk pace just the can

Tim Walbert

expect and I we expect specifically think the just results. us we more it's get clarifying to when tracking as

Tina Ventura

concludes morning. hours. thanks, this this and Great. be will call Thanks, webcast Thanks approximately and Mike, available our That joining. X A of call for in Olivia. replay

Operator

today. for for gentlemen, and does your you Ladies that participation. the Thank conference conclude

may disconnect. You now

Horizon Therapeutics Public (HZNP) 1 Mar 222021 Q4 Earnings call transcript