HZNP - Earnings call transcript Q4 2018 | Horizon Therapeutics Public Ltd Co

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Operator

Good morning, and thank you for standing by. Welcome to the Horizon Pharma Fourth Quarter and Full-Year 2018 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 of Investor Relations.

Tina Ventura

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

results Executive today Walbert, the will Paul our Executive Commercial update and Chairman, closing and On for Shao-Lee your a Executive After guidance, remarks the medicines. full-year review discuss Executive and Development quarter Tim programs Karnani, will Tim President, me financial with Lin, Officer; Officer; on clinical rare Financial Officer; will Officer. the take call XXXX an and questions. President of the Chief of Bob detail fourth from Vikram Paul provide and are Chief business. Chief and Chief Tim, President, on Business Chief Vice President, Shao-Lee disease and will our Scientific President, Vice development and Head Vice Carey, high-level Research Hoelscher, provide performance Vice Executive Officer; we

we for about strategy press that year forward-looking XXXX today's this are to filings certain will various are during making reminder, subject expected the risks events. and projections, a financial of These timing made and XX-K Commission, statements call, As including future December be impact with statements ended our morning. release, our earnings our which annual described was and including on Form Securities our statements, and XX, report the in Exchange the business issued

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

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

Timothy Walbert

successful Horizon. year Thank XXXX you, a and everyone. for good highly was morning, Tina,

first teprotumumab for of enrolled In flagship to to we and maximize KRYSTEXXA. eye a growth therapy We Phase robust executing were record to strategy for ever the disease financial this topline made We without medicine pipeline markets build anticipate our schedule patients ahead data to quarter. thyroid differentiated III suffering results, our hope clinical progress option. treatment of on tremendous trial the bring and to and addition thousands

year XX% on KRYSTEXXA. full- This sales growth of target organization also started result We XXXX roughly doubled a one-year direct delivered net our our for ago. which of is having we commercial

invest painful We KRYSTEXXA very disease. to patients many from disfiguring and continue in help more suffering uncontrolled gout, often to a

XXX,XXX gout-related that last over type than more believe of this fact underwent KRYSTEXXA last prevent can certainly amputations resort help patients the In years. measure. We five

was execution and Rheumatology quarter rare achieved focus the focused Our XX% results This This the net financial a was since are sales, have making to first three million. the company we in EBITDA into sales $X.XX working. and sales on performance million. investments segment we the well and million $XX the years a the for $XXX makes and rheumatic nine billion, The annual Orphan, in and quarter capped net we XXXX. performance, KRYSTEXXA of of value we guidance. year up XX% off to impressive sales rapid quadrupled with Driving segment full-year account our $XXX adjusted record growth XX% its in strong in fourth you approved above the successful our a that total a nearly ago, medicine net years segments are was increased reflecting of The acquired into XX% strong sales diseases. in company, by net when increase take evolution KRYSTEXXA our is

total KRYSTEXXA the And increased existing of compared KRYSTEXXA vials to representing accounts, year-over-year. end of increase XX% XX% from new During XXXX, we opened at accounts XXXX. accounts XXX an

sales Both of fourth medicines, by quarter. for Net growth double-digit medicine expect XX% RAVICTI XX% full-year in PROCYSBI grew and for strong for our We both remained and the to Orphan continue Demand KRYSTEXXA driven XXXX. growth medicines the respectively the have profiles patient treatment-naive physician are from to compliance. for made confidence to improved labeled served the their clinical and benefiting increase treating of we medicines in the younger, patients. indications, which updates

the in Our medicines. few in III milestones to Shao-Lee the current our addition topline strategy, Phase development of progress fully is expect we success or thyroid antibody key all in beginning I’ll ahead developments and With and enrolled which teprotumumab, R&D for This XXXX in in our our she TED. receptor disease well leadership inhibitor III more results maximize the mirrored trial by detail. the year support commercial organization's and was clinical Teprotumumab team, early our now. new our quarter. Phase team Shao-Lee medicines with with will We this is the of into in patients discuss monoclonal then IGF-X R&D new built a out human brought benefits schedule highlight and progress of bring R&D. eye leadership is of enhance capabilities. Lin to our

serum assuming We from only if TED. data medicines the treatment impressive continue uncontrolled mid-year approved a would BLA approved clinical for XXXX who the patients suffer acid. from We're gout investing and also to teprotumumab uric more efficacy its to to be positive anticipate maximize enable submission reducing KRYSTEXXA and benefit value and first

which underway, with of include KRYSTEXXA trial the immunomodulator combining The immunomodulation used initiatives methotrexate. MIRROR, is impact rheumatologists. by our most evaluating Our commonly

uric of increase it's registration, our in makes our patients patients in uncontrolled base patients We to this Today, population to quarter. supported rare and these to the you the to estimated transplant transplant begin of expect Can demonstrate compared XXXX, the Orphan this and which us. gout. the a second important XX,XXX with the medicines in more tenfold evaluate, efficacy over as half we advancing disease the we In and to third prevalence a population, potential than segment trial in to KRYSTEXXA. little general support an about asset patient initiate drive growth, to an kidney with KRYSTEXXA are of second a continue addressable serum Rheumatology durable year patient expect and by KRYSTEXXA announced to of trial acid plan population we levels currently reducing continue MIRROR the our gout that for

In sheet pursue our allows cash us addition, on expand the $XXX opportunity balance pipeline. to million to external in our

Looking in and net million and to expected the future, our net more our high which double than sales. opportunities if teprotumumab current approved each growth KRYSTEXXA than $XXX more peak sales,

acquisition of an growth, pipeline, many KRYSTEXXA Finally we expansion with long-term believe teprotumumab margin deliver to over augment the potential continued come, in potential turn position shareholder growth growth to I'll beginning and Paul. now for years to the additional expected XXXX opportunities our and in excellent value. to we’re it from strong

Paul Hoelscher

otherwise Thanks, segment segments. generated Tim. were sales noted. focus of million, quarter of of and My This our the and $XXX.X million increase net operating $XXX.X increase results of XX%. Fourth in non-GAAP income quarter, primarily an comments by this of unless net $XX.X segment million an driven nearly Orphan continued in Rheumatology strong sales morning will generated our growth XX%

both discussed we've KRYSTEXXA As efforts. previously, investment pipeline in our increased commercial in our we our and significantly XXXX

our points and increase quarter KRYSTEXXA the operating segment XXX sales year-over-year. RAYOS, and basis fourth With continued improved orphan growth from medicines margin in

Net segment $XX.X of For the $XXX.X $XXX segment of generated was sales sales the net million increases income and and full-year, million Rheumatology were XX% Care the income for $XXX.X XX% million, operating operating segment was and respectively. Primary segment million. Orphan and

invest full-year, which million. into the operating $XXX.X primary our net back we Primary the $XXX.X operating generated to For care segment of million delivered improved continue income sales Care, segment business and and of segments. from Orphan Rheumatology We income

Non-GAAP investment sales. net SG&A fourth teprotumumab $XXX.X rheumatology well were $XXX.X the quarter for non-GAAP flow million XX.X% as reflecting expense million included shares income program. operating non-GAAP expense calculate XXXX for used was Our gross XXX.X quarter million quarter and tax $XX.X ratio as share fourth weighted-average our per of of pipeline the quarter. and Non-GAAP non-GAAP net GAAP were million, The fourth million. non-GAAP $XXX.X diluted was income was to respectively. Non-GAAP was Adjusted fourth for outstanding $XXX.X million quarter. and EBITDA profit cash R&D million. $XXX.X million. operating Non-GAAP expense was earnings were $X.XX EPS This diluted in expenses shares $XX.X the fourth

at cash of long run a XX, way significant our first The and our gives is until million, debt due business. to net principal which flexibility debt-to-last of our X.Xx manage we a EBITDA and our were end equivalents debt amount outstanding leverage billion, which December XXXX. adjusted have of the XXXX. and As maturity $XXX.X was not X.Xx, total Net to to $X.XXX cash compared billion, was months' ratio $X.XXX was XX debt

commercial continue KRYSTEXXA. to our execution guidance for $X.XX morning Rheumatology for now we provided segments. expectation to XXXX another year by project of XXXX, net our of $X.XX outlook double-digit we Moving Orphan full-year of growth our sales This underscoring full-year In billion, billion and to driven net sales XXXX.

incorporates representative sales outside net as which quarter, single-digit longer care, price of sales full-year RAYOS sales will in divestiture and AMMONAPS decline for the this in U.S. United three our to With BUPHENYL Our net markets. soon the also Japan outside million year. all a in or segment no known sales America beginning XXXX LODOTRA, we as our about that the Therefore medicines net regards the and guidance domestic guidance XXXX increases the in year-over-year LODOTRA as known North recognize States. in as of the RAVICTI, primary AMMONAPS the of U.S. with first the RAVICTI no and with $XX

and to deploy to support Orphan our flows continue Rheumatology will investment care primary in segments. cash We from the strong

data. reflects million increase prepare in Our programs drivers, launch in our KRYSTEXXA key III million and our in also assuming $XXX to uncontrolled Phase teprotumumab pipeline XXXX It gout continued adjusted incorporates the studies including new EBITDA KRYSTEXXA XXXX. to full-year spend of potential of U.S. two positive guidance investments investment including for $XXX an continuing growth in

KRYSTEXXA trial kidney transplant immunomodulation registrational MIRROR Our patients. and trial our with

single-digits non-GAAP percentage profit be Non-GAAP making reflects ratio R&D expect year-over-year be programs. teprotumumab as which XX%. prepare year-over-year A significant approximately our to a by gout increase launch. non-GAAP XXXX. for driven to of U.S. we primary and high in are SG&A uncontrolled We KRYSTEXXA the investments gross is sales pipeline increase the are the anticipate expense, potential We projected a to for expense in

interest non-GAAP net between to and $XX full-year expense range $XX million. million expect We

teens. tax We low-to-mid full-year rate the expect and non-GAAP the

variability single-digits anticipate rate we the As year to quarterly the in our will be we estimate a next in the and XXXX cash our tax every that rate non-GAAP We mid-to-high-teens on years. over basis. see increasing several tax low-to-mid

projection As changes could made in laws. a of the company this tax always, change is any divestiture by result acquisitions or as or significantly any

sales full-year million shares. and XXX adjusted we than higher for count net expect diluted our weighted first growth expect share XXX XXXX and And XXXX to million quarter EBITDA. between be for We finally, average double-digit ranging both the

net We sales of with approximately total expect net years. full-year XX% sales in line XXXX prior our to be

As we patient generally quarter in the changes discuss by are lowest or patients every impacted sales deductibles reset the as net experienced year health first coverage. their insurance year seasonality of

addition pricing KRYSTEXXA as In see as will we for impact expected, seasonality. as well from XXXB an

net be We percentage as to KRYSTEXXA a we in net expect XXXX sales full-year or sales XX%. the similar saw first quarter of approximately

We full-year KRYSTEXXA. sales double-digit for continue growth net to expect

double-digits over We low a EBITDA. is the call quarter expect adjusted line with quarter turn first XXXX This adjusted full-year With of in that, the adjusted contributions to in EBITDA EBITDA prior percentage our years. Shao-Lee. be first in to now I'll as

Shao-Lee Lin

and Thank morning, you, good everyone. Paul,

programs Eye our for the our make current TED. with monoclonal strategy our advance We medicine. Disease development in update begin maximize fourth our inhibitor the antibody and on continue in quarter benefits development of I'll on-market pipeline, IGF-X today's treatment teprotumumab, receptor the strides or Thyroid human the expand fully to research of and to our

from about thousands disease. given particularly treatments our almost the both We’re that despite demonstrated bulging two additional the no study, or TED. for II schedule. confirmatory teprotumumab milestones enthusiastic on proptosis in achieved of the vision. of this effect trial the One, teprotumumab. full-year for III demonstrate potential they ahead patients response II by are fourth approved of therefore a we believe secondly, or TED significant we OPTIC, Based the treatment And double post this the therapy a we the disease eyes modifying durability XXXX, first quarter data data presented there we of Phase the for and be and approved impacted enrolled has Phase In that program for diplopia debilitating Phase to

to XXXX exciting expect We be year. an

teprotumumab points of in orbital in about of pressure can with in the primary brief on living proptosis that III daily The with of XX Phase mid-XXXX results car, objective overview physical a the match provide of and data are key a OPTIC. is those local inflammation, III and several Phase BLA experience even eyes, FDA Phase patients topline and over-expressed detrimental some X with anticipate we in In As clinical result resulting trial like to as of measure. such assuming primary The Phase fused investigators are first continue morbidity upon of tissue in leads It nerve also in XX be Therefore, highly even Phase course quarter experience endpoint enrollment walk In is the X orbital poor we’re receptor to is These blinking the the the trial. itself. the read from placebo the ulcers for XX trial drive fibroblast result turn weeks. proliferation blindness. activities and and TED Overall, the trial. submission Phase downstairs. double enrolled the Proptosis OPTIC data the a similar reduction simply even patients can criteria swelling, in their design and tissues patterns an proptosis data. investigators II may the instances, ability positive agreed also every the a the measurement proptosis. patients the Patients eye readout, of closing Ahead called XX% or discomfort over of which expect sleep IGF-X of Phase that is to was in the or III weeks III can same. painful vision. diplopia I'd to teprotumumab this be TED, to importantly, three of outcome III to confirmatory on optic II, which the can result surface TED once

treatment to benefit OPTIC-X conducting also from teprotumumab inform from an up XX longer OPTIC-X if extension drug weeks of an as will of weeks weeks will the OPTIC study, lose are help to whether during treatment. patients from allow would benefit XX us of would initial initial We additional response that from the XX who Data treatment treatments and after retreatment. of non-responders

programs milligrams response over less of our trials, a benefit XX% for approved treatment our Phase KRYSTEXXA given KRYSTEXXA, serum its strategy of gout. component a for the now acid in per Moving to is uncontrolled only patients, FDA uncontrolled In patients core clinical is deciliter pivotal X that for of the gout it achieved complete uric the KRYSTEXXA III level maintaining months. than maximize X

patients we potential antibodies. to Our a and goal is to to rates. complete KRYSTEXXA increase addition biologic the number reduce evidence with investigating has ways the to the of achieve immunomodulators can And the There's do therapies who the of antidrug improve formation are of this. response response that therefore

college on of investigators rheumatology the of fourth we to are on MIRROR study methotrexate, we quarter. annual of As case last quarter, co-administration effect conducting in the discussed by based response evaluate the rate the the external presented at a with KRYSTEXXA series positive meeting

course study potential the for in are process MIRROR adapting the the of of registration. We

trials begin XXXX. placebo for the in of second in initiating in controlled transplant excluded of original to These part trial expect evaluating enrollment we quarter as patients the today, KRYSTEXXA XXXX half kidney we've the the studies were and And as clinical second as We pivotal also shared the are MIRROR adapted of trial patients. in randomized KRYSTEXXA.

as organ of that XX gout is more general with uncontrolled serum as patients and However, patients. there to will in its are effectiveness and significant uncontrolled acid serve to they also also than when KRYSTEXXA Managing and opportunity use have inform uric of disease the for the levels literature for fold population of the kidney gout unmet kidney and further trial potential common rejection. a an chronic increase transplant high This to prevalence need compared benefit nephrologists associated the both suggests gout. of

optimized and programs, which in Two of includes uncontrolled to of designed potentially biologics, are sustain well exploring uricase our gout. three these rate. in and as half-life we our to next-generation molecule continued enhanced technology response PASylation advance the pipeline of XXXX, Finally, improve enhance as programs the position PEGylation programs to preclinical the the technologies use leadership to optimized our

for We programs. both are targeting subcutaneous formulations

we The capability Hemoshear a Therapeutics. for acute provides recently lowering chronic us That which novel the to discovery with with announced third program, serum levels feeding in long-term uric collaboration is targets and explore the gout flips. acid gout

turn concluding Tim always, the you call for progress. I updating our continued As to I'll look now his forward remarks. to over on

Timothy Walbert

and In medicines a the of enhance building growth million. significant and Shao-Lee. and XXXX double-digit KRYSTEXXA Company. you, both We of rates Thank $XXX summary, record pipeline to billion year the sales transformation generated made in differentiated our our maximizing EBITDA adjusted continued robust leadership $X.XX gout. was of progress of net from We uncontrolled for

net with on of We're rheumatic strong in working from expansion. and strategies execution continuing now our diversification building our Our and drive generated sales XX% total XXXX, that pipeline rare commercial to disease momentum medicine.

expect growth quarter. with looking read We teprotumumab’s KRYSTEXXA Orphan and data growing the segment topline our out forward sales III net double-digits. from Rheumatology We're continued Phase this to

So data, BLA our intend to preparation. in begin submit launch mid-year we positive our to by

including patients to our continue new gout. also from that the transplant MIRROR have and to patients KRYSTEXXA, KRYSTEXXA gout kidney trial programs enable trial registrational our in more advance We uncontrolled uncontrolled benefit

growth well questions. With leading delivering rare So on it exciting being our that, and considering disease for open value we’ll shareholders. where time patients, of for therapies for Horizon, long-term for our Company, way Tina? Biopharma goal innovative our are we towards at sustainable up

Tina Ventura

Amanda, go ahead.

Operator

line first Dana from of Sachs. comes the question Our Instructions] Flanders [Operator Goldman Absolutely. of

line open. is Your

Dana Flanders

impact maybe how years? the in Tim, your see speak question, for business margin for given XXXB you next to pre-launch low have grow the a KRYSTEXXA, really My like on tepro can and several story That to and powerful margin point And all congratulations profile Orphan the business. just Thank spend. me expansion as that you you the you then is evolving the the XXXX you questions first the progress. a Hi. on just seems

and just take comments then to know there time? leverage And And think down, that own Thank secondly, the So relative out to over profile I peers where can deal you you. maybe down what maybe the balancing, tick landscape. in seeing bringing on – flow? you some our on you're margins continues you're profile curious orphan your M&A, how just leverage just

Timothy Walbert

maybe Bob, Paul significant deal view how teprotumumab can look then a and so certainly to debt Bob? our for and XXXX how – margin. address is address we continue the gross the environment, and we at investment But we be by excited that, year

Robert Carey

Sure.

Dana, thank So you.

out We opportunities there. continue see good to

able ratios talked is would this been reduce stage and buying licenses would focused our – we very got careful And managing disease bolt-on overall leading the would aspirational through we've been debt the group we've to changed that that are debt We've acquisitions And rare cash medicines to our As that development keep of about pipeline. transactions from a debt build we've as that about focus large of incur or that, flow. levels. that companies. leverage on peers result

that's companies into so for as is ourselves we like move out those And the future. we more look goal that forward, set the to

how we pursue as that that to being to debt of that's assume move we manage the move about Paul? that levels overall smart as and So through, that we about smart it's the pursue, think but fair forward, transactions can well And manage cash. we we we will trend that direction. deployment being the as that

Paul Hoelscher

year comments indicated your an as is new XXXX guidance. EBITDA much on. margin our – our is were by investment Dana, spot on pretty

the up have up have ramping don't from throughout preparation to for into we look that assuming sales year. that'll full-year commercial we significantly product. we expect spend going as data on the we're And of launch XXXX, a for So tepro, to for the tepro be positive ramp

profile so XXXX. we that significant think in into and see KRYSTEXXA as we it's And I a tepro both XXXX, the you to into leverage really as move change going as sales margin move you're

Tina Ventura

Dana. Thanks,

please. question next Our

Operator

Thank you.

Our next David of line is question Amsellem of from Jaffray. the Piper

line Your open. is

David Amsellem

Thanks.

couple. a Just

And wanted you're on gout may kidney like other expanding other first focus KRYSTEXXA, it sounds consider on on exploring to detail get I the further just further some who the you there subgroups beyond So populations. transplant that the patients? words, already they’re on are patients well. so sync already agents, other underlying then are secondly, immunosuppressive on pretty an KRYSTEXXA immunomodulatory therefore these In would rationale agents. is

on risk combination the And So strategic again, intuitive. segment? at sort the talk for over care Thanks. beating any head is of that the once can about thoughts, new lastly, then this fairly any, you primary options of if

Timothy Walbert

take the I’ll flow expect have stable, no We it’s anything and intentions best care. we address It's generation. strong flow us. see significant one. to cash than primary that maybe by of driving with doing cash Shao-Lee, managed other continue business the first

Shao-Lee Lin

Yes.

said, transplant these that So kidney speak I trials. patients as pivotal from are can to the And population. were our we excluded

of to have addition they some medications the their as well that to patients some in most so, as they're are really mostly the the of And that gout forms of disease on. that, severe kidney chronic

as So consults gout. when saw as I rip-roaring them that a I tell hospital really and rheumatologist, had these the you in can patients

So able KRYSTEXXA. to that we unfortunate with it's previously weren't them treat really

been there uric transplant. organ I acid that to immunosuppressive their think chronic in the literature fact of – levels high the really that that spot interestingly, therapies rejection. also suggest out serum And terms on because immunosuppressive they're contribute organ of can heavy on you've

understand use going this we nephrologists an of because So a experienced that population to think there's label, to think – picking state the nature. ultimately as up learn potentially also high more back treating the get and it how disease in effectively. gives and nephrologists, systemic with this that KRYSTEXXA for urgency that KRYSTEXXA opportunity We

David Amsellem

about mentioned… populations other What you gout that

Shao-Lee Lin

we're always for about for foundations. to certainly the others kidney at time, We don't thinking gout have KRYSTEXXA any maximize this share benefit to ways but

Timothy Walbert

with gout kidney the are and patients remarks, of over chronic third the patients. a refractory I as my current transplant is in said about gout uncontrolled as And which we addressable XX,XXX see population a

went can significant that leverage through. see we that Shao-Lee So opportunity near-term a that we as

Tina Ventura

next please. question Amanda, Thanks David.

Operator

Okay.

question of next Samimy Your the Stifel. Annabel line of from comes

line open. Your is

Annabel Samimy

of want just starting within the to I response taking now wondering questions a trial questions. teprotumumab. a the to KRYSTEXXA, for getting the want you the this about my going nephrology could help have understand to you dynamics be specific right a good on of I little was capabilities outcome. in trial. But to just bit. like qualify statistical nephrologists considered is how It that of looks And kind penetration wondering is Thanks. transplant I'm been that rate with us. understand to thanks drug. entrenched just trial And does that kidney even to if what it considered is clinically necessarily simply response may not segment, or looking nephrologists a just gone referred these for relevant I being be can Do that be other rheumatologists back for? maybe us frame expectations centers about certain a tertiary infusion successful and rate ask for patients significance that the does has So would around threshold We've mind? commercial or given Hi, opportunity capabilities, lot separately of centers your you matter they this given help change you're in treatment?

Timothy Walbert

clinically for significant the at III millimeters patients. design two by Phase their relative So looking at to and I’ll the confirmatory greater if millimeter you of as be trial. was first the of with a the back II III than than programs, eye Phase reduction Proptosis take the the Phase program greater expectations. or look resetting socket, was community Again, and to a The into two designed determined

the efficacy is excited we're ever nothing confirm the had this before, month. and over to having goal in So so next that population with get to data our

So with that, maybe over to move KRYSTEXXA.

Robert Carey

nephrology nephrologists, do it Yes. about it expectations. or understand that for community. experience another that with either your doesn't sure make patient the site rheumatologists care institutions point themselves, almost our they to line in performing to to hospital care And is with perhaps capabilities I in though infusion community in important is to KRYSTEXXA, on the right the partner patients do they think maybe, even because is or entrench with matter need. refer may not other of that And they in the get the have To

Tina Ventura

Annabel. Thanks question Amanda, Great. next please.

Operator

Absolutely.

from David question Steinberg is next Jefferies. Our of line of the

is line Your open.

David Steinberg

Good morning. Thanks. questions. Two

First, next your then indicated think expect product? finding year. you how secondly, given and teprotumumab current And thinking initial in on you'd are you approval, with when competitive regard if KRYSTEXXA, your competitive about first I they the launch What's peak bought are that for patients. that it'll just with to not launch that occur. will to you give drugs? approximately landscape others, do Could It pretty the you you years seems and you XXXX. how are over you color orphan us take some sales patients think than probably get thinking quickly threat get known some the about peak like reached the there Thanks. time? All new may well I'm cadence curious, for many always competition to

Timothy Walbert

when competition, to I the in competitor KRYSTEXXA, timing Relative think and a it has we we said Dave. delayed. Thanks expected you well, bought XXXX

teprotumumab, include So our we're be having million forward-looking than $XXX not board, forecast to growth competitor guidance. XXXX greater has there. on nothing and in to double-digit sales, and providing of going Relative in peak changed a

data, that the at time, medicine the will you we and on BLA If approved, get the and file teprotumumab. provide hopefully guidance

Tina Ventura

Thanks David. Amanda, next question please.

Operator

Absolutely.

Our Cacciatore next is question Ken the from Company. and of Cowen of line

is open. line Your

Kenneth Cacciatore

Thanks. Good morning, guys.

time the is first it around I heard teprotumumab. question refer It's disease modifying. you maybe my as I wrong. I've believe to Just

to it about for maybe kind it's in decisions? of talk ability studying I potentially So you just of you're it and longer, that but in implications wondering, pricing we're OPTIC-X the the have use for obviously hopeful successful, terms size may maybe change earlier. study? know for can And you and data ultimate around the alter how frame of waiting of then that on I'm wondering sales kind for might equation just your maybe can in frame terms how with you that you. beyond Anything the III KRYSTEXXA? the may success. Can Phase also peak MIRROR, how us Thank the utilization and

Timothy Walbert

active population late. work. early byproducts. versus is as medicines relative no to that see categorizes There's it for teprotumumab, The we So or don't the disease

we disease. medicines and So with first years for as estimate confirmed be if approved, That what XX,XXX be not data agent would – the disease XX,XXX between that comment the approved. be. active At those and to patients annually. three population, active is again, pricing if have see more for patients patients the teprotumumab would that the appropriate going medicines within We on and right point, to may this we're

data. still are I and stories was patients we are into now think KRYSTEXXA, the point peak response. XXX,XXX We second that every our the peak around five that that would data, we so opportunity the continued relative combination amputations some confident last we've confirm not fact positive business built the should excited that physicians at saw sales, the MIRROR results the avoiding we're in opportunity. over trial we methotrexate ACR from update question But that to and sales around did has seen day getting get of with those the it how time. is, about years, We we're have

Tina Ventura

question Thanks, Amanda, Ken. please. next

Kenneth Cacciatore

Thank you.

Operator

Absolutely.

of line question is of Chen next from Cantor. Our Louise the

open. is line Your

Louise Chen

questions. I here. taking few had a Hi, for thanks my

So question I had first tepro. was on

this you then on would you secondly if treatment bolus benefit fast is from of M&A. how product? do would the Just think a the uptake there curious be for think patients and that And

are therapeutic you Just pipeline have more you to what to interesting build much and Thank existing towards Where areas? this What's or capital in? Are new any you. on would assets? how curious commercial deploy interested you there areas?

Timothy Walbert

our this the guidance the second helpful. know we're these providing in data's focus these research on time. not around point patients we thing is pre-launch Maybe guidance both have and isn't identifying But patients, difficulty from and in the would positive is that at as there uptake as peak address to efforts obviously Relative One diagnosing patients. can that and Louise. Thanks, assuming it's we which believe question Bob M&A is, times environment. at far sales, that,

Robert Carey

Louise. Sure.

So order over need $XXX with purposes a on capital working our on we for little of balance million. million $XXX sheet, the

rheumatology we And and to that We in in rare that to look today, diseases. have metabolic orphan objectives at are $XXX somewhere within first which neighborhood diseases. point. stay the is the the areas of got deploy capacity are we million So played that the we've this

We expertise The have team. pipeline. that of at continue a that the also the at. the then is of have immunology amount space we considerable to because the out white to joined And time spent there's people objective R&D of look looking build opportunities

much to assets likely assets opposed the be at on point. that's stage. We this capital more So stage – commercial likely think at it's this us development return to for more as greatest

a we forward. allocate how of move view and we outline that's how we're capital to so the world as planning And

Tina Ventura

please. Amanda, Louise. question Thanks, next

Operator

next JMP our Securities. from comes of of Donald line And Ellis question the

Your open. line is

Donald Ellis

regarding My my good us first Thank sure Tepro morning. reduction III you, And endpoint. for endpoint? to the you XXXX is rate. regarding question second greater questions. taking indication single-digits? and that give is proptosis? hear question quick objective heard I make How is could or guidance Thank subjective you. Phase correctly two-millimeter than And the the regarding I the mid want some I primary and tax That's did Thanks in the of it.

Timothy Walbert

first. the tax question For

Paul Hoelscher

a from out actually expect we to what the tax is mid-teens. we said, single-digits a cash cash On Mid tax rate Yes. rate, low door. non-GAAP standpoints

Shao-Lee Lin

that's measure. Phase primary with endpoint, a effectively regards with the measured actually to It’s device specific is objective [indiscernible]. And III that Teprotumumab

Donald Ellis

Thank it. Got Okay. you.

Tina Ventura

Thanks Don.

Next question please, Amanda.

Operator

Morgan question line next The Stanley. the David of is of Risinger Perfect. from

open. is line Your

David Risinger

much. very Thanks

So have of please. a couple questions

the you with result respect of that I KRYSTEXXA, reduction they be as XX% adjustment. to a XXXX XXXB think said had would First, a previously

to XXXX the if net XXXX. income still Just And with expectation. versus adjusted that operating is it declined to flow wondering cash in respect

net for get Thanks operating income? Just much. adjusted expectations very hoping to to XXXX flow your cash

Timothy Walbert

KRYSTEXXA to growth XXXX. relative our expectation Well, for over to double-digit be continues

So nothing has changed.

Paul Hoelscher

did look flow the still due one-time decrease PBM the change with enter as end of pay to contracts. of had at to contracts We cash of versus rebates the year what not we a those about is flow as XXXX, – XXXX talked primarily and cash of benefit we we in kind the year. owed the at full-year last being some the of them full-year because a the And

benefit in that So we had a from XXXX. one-time

interest cash you guidance, operating but is what due and growth and EBITDA working flow. for flow forward, if can said adjust for in you the then operating cash growth some we've a Going sales and proxy that and at look good give we that give cash taxes cash capital to don't

Tina Ventura

question Thanks David. please. next Amanda,

Operator

you. Thank

line of Nachman comes Gary Your from next question Capital of BMO the Markets.

line open. is Your

Gary Nachman

going? a will with able would might a those protocol RECIPE data and How be this qualify you more as year adapted when immunomodulators? have from do where and have you expect and MIRROR an that little On any so Hi, label and trials good it were How the to the morning. will and data study. trials can studies to it file KRYSTEXXA, registration big other updated on for use the be for there you other TRIPLE be

Shao-Lee Lin

trial trial, of regards registration find conversation it's for to design. acceptable MIRROR with we're actually FDA in adapted the terms going a have of they terms the the ultimately in So will what with about the to that

it a update data. months minus we be after specifics And on a will most KRYSTEXXA couple any duration, able the conversation. evaluate you plus better it'll it'll that before to or fully to of methotrexate. are we That be be be the So design in said, six likely, to but years ready expected of

Tina Ventura

Gary. Thanks.

Gary Nachman

Yes, the TRIPLE and RECIPE.

Shao-Lee Lin

Yes.

of terms in trials funding we're so or been we're along our not no moving There for that So hoped nicely. RECIPE that hasn't uptick that for for actually had initiated we longer is that and seeing recipe study. ultimately investigator the understanding TRIPLE

Tina Ventura

Gary. Thanks

Gary Nachman

you. Thank

Tina Ventura

question Next please.

Operator

Perfect.

Koffler next Mizuho. is the line Our question of Irina from of

line is Your open.

Irina Koffler

my Hi, taking questions. thanks for

any these doesn't at wanted And still segment, Just include When business? I additional to to can opportunities for in it many from had clarify that sort question – or as was margins of to kidney, trials? MIRROR expect decline target? we is of go wanted primary there And Thank to product that the then back million XXX to improve operating kidney get second KRYSTEXXA. the I start you. care to the you upside

Timothy Walbert

If increasing you margins sales to we efficiency. and primary essentially the flat care at continue and our look XXXX, we business look for across and

very in uncontrolled your occur. So and sales is and as kidney you and are correct we MIRROR that patients. guided to haven't the transplant gout expect operating to we peak study in And when will KRYSTEXXA, with far how million XXX as we that pleased were assumption or relative

Irina Koffler

Thank you.

Tina Ventura

Amanda? Thank you, Irina.

Operator

And time, closing Miss, the I'd Tina for you. further to the are questions. like turn at Ventura Thank back remarks. no there over conference this to

Tina Ventura

thank call replay this you and of approximately A call Thank our joining available And morning. concludes be you, webcast and this Amanda. two for will us. That hours.

Operator

you for your participation in the This gentlemen, conclude Ladies program. and does conference. today's thank

may disconnect. You not Everyone have a great day.

Horizon Therapeutics Public (HZNP) 27 Feb 192018 Q4 Earnings call transcript