HZNP - Earnings call transcript Q3 2018 | Horizon Therapeutics Public Ltd Co

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Operator

Good morning and thank you for standing by. Welcome to the Horizon Pharma plc Third Quarter 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.

begin. may You

Tina Ventura

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

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

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

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

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

Tim Walbert

morning, to increasing to expectations million. We adjusted Tina delivered performance, full you, good and our $XXX guidance $XXX of quarter and million strong Thank another year everyone. exceeding EBITDA

approximately XX% by and sales XX% business. were KRYSTEXXA. segment, quarterly including in record growth of driven growth rheumatology represents orphan in Our net XX% now our our segment This

data growth gout In come. to patients confidence key our thyroid new the of years for uncontrolled in eye KRYSTEXXA addition, teprotumumab, exciting our many recently disease and on high their lives ability and potentially reinforce presented improve drivers, to

and that disease of the X in double meetings recently the that key a all treatment conviction thyroid decision diplopia this medical two disease, endocrinologists, important our major encouraging the markedly this Let advancing developments X series me With presented X the ocular our patient These American eye off month, number be patient. makers and a medicine disease. vials monoclonal X for three surgeons, used year patients immunomodulator highlight we're new Annual at of improved vision. on significant eye data Meeting phase With with KRYSTEXXA modifying response, Rheumatology data showed the or findings, quarter. patient at all average eye the these development to responding. new thyroid that a new KRYSTEXXA case methotrexate for external support adding that million responding reinforce College trial, IGF-XR to inhibitor fully response, sponsored last endpoints, teprotumumab, the proptosis registration. KRYSTEXXA, has trial potential phase in presented of therapy. plastic potential upside Horizon from more sales estimate MIRROR annual also for for as antibody than to patients data number bulging the to increase to clinical We of full strategy, durable was treatment has assume not as the $XXX KRYSTEXXA any a potential does its peak our or showed reach human a almost well immunomodulation which ophthalmologists potential our which each Based of We for net

for vial we Moving growth. driven for year-over-year PROCYSBI. orphan of by continued by net third record RAVICTI KRYSTEXXA, XX%, and $XXX strong sales driven million of to quarter and sales million, KRYSTEXXA quarter had rheumatology our results, the segment the XX net increased

commercial into opening we're our in generating expansion effect early prescribers. important ways. from and in growth two accounts year, the new that Following existing growth went We're we're generating

opened ended fact, XXX to more where than increase In to year date, new an compared we've accounts, than year. more XX% we of last

our see investments addition, significantly. working we're of is vial growth prescriber up to the The and we business. making acceleration base In are also in existing continue

XX% growth our We than remain continue growth quarter in confident accelerate to of net ability the to vial and expectation KRYSTEXXA meet sales for in fourth expect our to year-over-year more highly on XXXX.

also untapped In addition with future opportunity laid Nephrology our American The for XXX remain We far more nephrology. exceeded expectations a of our KRYSTEXXA educational excited in only attending. room growth strong within about where the to nephrology. significant presence foundation our symposium at attended and Society than we Meeting was traffic ACR, our the standing nephrologists booth

compliance. medicines continued younger increase have naïve strong RAVICTI, by these with RAVICTI when are confidence quarter to XX% indications, Our remains benefiting labelled the sales generated and growth patients and driven net and improved physician are and and third orphan PROCYSBI growth treatment Demand XX% the profile medicines. treating Both both medicines, from updates in of for that respectively. clinical which patient strong PROCYSBI

expanded to indication of which the to contingent by expect year, population patient decision we’re RAVICTI the X-year approved of reinforce to this for on clinical the from FDA end a continue birth the medicine. this benefits the if We

therapies medicines. the treatment as conversion for from naïve of generation older patients addition year-over-year the well contribute to both Continued growth as patient

teprotumumab investing for opportunity our focused making expanded we're and the which commercial We We're the investments continue manufacturing to and team KRYXTEXXA well initiatives its driven drivers, we're potential launch. investing clinical commercial year. as for in this tremendous to with is has our US prepare growth program what see as

achieve patients it. turn strong to returns is to path I’ll shareholders goal it therapies well for to innovative on and deliver Horizon our generate now over Our our to and Paul. we're and Pharma

Paul Hoelscher

primarily and rheumatology this quarter segments. focus Thanks, were third unless growth otherwise were of Tim. for million, My non-GAAP million. orphan our driven results strong Record rheumatology noted. segment continued operating sales an our Net will on $XXX.X sales by of $XX.X orphan income was and net and XX% increase million $XXX.X of comments morning

As net and operating income. and for Year-to-date, previously, represents and rheumatology segment to investment in the both growth total income operating sales the million. approximately primary segment of the we our over were XX% increased clinical we care significantly of KRYSTEXXA $XXX.X company have segment sales discussed term teprotumumab. million medicine accelerate in and $XX long segment development Net was the of the orphan this total

EBITDA non-GAAP calculate EPS The $X.XX Non-GAAP were non-GAAP for $XXX.X outstanding XXX.X shares tax Non-GAAP operating trials. profit was of per net and weighted operating to million, non-GAAP reflecting third cash to quarter used quarter in included and income Non-GAAP was the expense shares million million. quarter well the investigator KRYSTEXXA third for earnings which somewhat third Non-GAAP $XXX diluted net XX.X% lower sales. million. SG&A income flow was expense $XXX.X and $XX.X quarter. expenses third average $XXX.X was million of expenses respectively. programs that investment the R&D were was expected quarter gross due and expense as fourth than as Adjusted Our shifted some was million, of diluted XXXX share pipeline million our the rheumatology ratio timing XXXX. from $XX.X to non-GAAP in were This $XX.X of initiated teprotumumab the million.

Our capital us structure in flexibility our managing provides with business.

$X.XXX down first XX, the interest outstanding cash of basis The in adjusted we loans XX point maturity previous LIBOR plus if of at was and below our gross is refinanced an until secured and $XXX LIBOR billion X.X to X.XX%, leverage total debt additional is plus September from borrowings interest months were of an our XX times. rate As net ratio equivalents October reduction rate at $X.XXX was and XXXX. times. XX not to X%, EBITDA senior billion debt On point ratio XX, leverage debt basis our cash or was X.X with the term million. principal Net our a amount last step our

approximately interest on loans lowered approximately expense XXXX, on our have secured we company interest an since senior basis basis. million the In XXX the the $XX annualized fact, by points, saving rate term in

We will as we efficiently and our manage past. have the leverage in debt continue to

XXXX billion, and $X.X million our million XXXX, in Moving expect for to be million. to to increase we $XXX guidance to EBITDA of year $XXX the adjusted outlook $XXX to sales range in billion year XXXX net an $XXX full from now full prior of $X.XX range of our million, range the

orphan medicines, XX% We continue year be for of to more and more orphan net KRYSTEXXA growth PROCYSBI. expect expectation and XX%. includes to sales strong and for projection full growth rheumatology than growth key our than our segment from continued This sales full net RAVICTI year

exceed continue $XXX primary net the expect full we year to million. For to care segment, sales

range Regarding XX%. line our to non-GAAP items, our other between projected guidance for XX% is profit and gross ratio

For well non-GAAP rheumatology digits of operating by Phase the year, teprotumumab clinical X expenses, to high R&D, our the programs. Based and we as this on we as a and by as single program work expect be for driven sales, development our to mid in full related percentage as in third acceleration fourth meaningfully be to regulatory teprotumumab year the anticipate R&D quarter this timeline, quarter. year the timing well compared our higher as clinical to of as the spend the R&D of our projects

impact in non-GAAP of primarily the reflecting KRYSTEXXA SG&A launch investment as anticipate commercial teprotumumab. as of full to increase We potential initial our to continue investment the year a well spending, prepare for spend year-over-year

to some the Full range be net the previous income of XXXX year fourth preparation at expecting $XXX is also for teprotumumab. a $XXX in we the increase are be -- of in higher range of spend as our interest quarter which shifted interest somewhat timing potential guidance quarter of that net We third lower quarter SG&A million is non-GAAP expense, to the expense expected fourth million. launch than from the of to due and to to expenses

the We rate single digits. high are full to non-GAAP year tax double to low digits in be projecting

as full XXX acquisitions now of share or count million rate finally, we projections turn diluted have the I'll previously, and shares. any XXX million year weighted our XXXX our Shao-Lee. we As be divestitures. And stated average over a result could to between to change tax call expect

Shao-Lee Lin

New approved maximize the we've an Pharma painful surface bulging reduction presented a period, proptosis XX of to Patients patients particularly our and programs, a Surgery we the both evaluation nerve weeks, teprotumumab, of XX% a one optic as is of eyes, build almost drug, overexpressed a other period, Overall, conferences expansion. at the be result to of The which today’s can and the durability living and the the the response. XX-week reduction. more Phase Thank for potential the benefits data has from These responded differentiated deemed detrimental as of driving good demonstrated in existing that XXXX. potential. of double the a off medicine. treatment It's trial Thyroid week in of even At demonstrated off teprotumumab closing treatment approximately our a fully full instances, for XX% and sleep morning, on millimeters demonstrated week of orbital no XX% believe year in At poor quarter. disease than dramatic were X% or well made that turn American less human in full proptosis teprotumumab Plastic Reconstructive first XX such potentially morbidity or during can followed Ophthalmic have data rare off week though in tissues XX patients October. meaningful a also blinking update mechanism Horizon marketed leads We patients and responders to just or The receptor of to patients of resulting blindness. advance We to XX, at time this and a progress and many proptosis in one the clinically is maintained patients year treatment the proptosis our highly study England After patients results for vision. In durable and TED. the at of organization, of walking teprotumumab modifying experience At underlying tried treatment, TED R&D approximately response improvement of and medicines of begin to in diplopia teprotumumab orbital or at three first therapy. their diseases Ophthalmology. X lead of can experience everyone. the medical capabilities And pressure demonstrate down two proptosis. in on for XX, a week that which response. for grow based Medicine X our on discomfort, XX ATA, XX support X-millimeter third post eye of with Data In or Society XX, for least period, October from the ulcers our inflammation, diplopia, X and than you, diplopia IGF-X itself. and Journal indicated a treatment as local the that which at or of address pleased with was least more activities not approved be stairs. pipeline that therapy. proliferation results, were in of today At offers of year exciting diplopia I’ll good for the the to and clinically as daily disease is pathogenic new allowing the belief another treatment. Paul responded TED off tissue or in some is one that the with teprotumumab week an disease TED week a inhibitor were of approved TED, where is car date study week with Teprotumumab’s result May therapy to Association data of response proptosis do TED simply the or the patients modifying development can The This phase XXXX on XX% meetings at ATA with monoclonal of receptor eye the year fibroblast American durable end The has thyroid disease. approved nonetheless The their change. treatment, exist present almost IGF-X treatments presented maintained antibody in American grade are eye the end not that the therapy. Academy demonstrated of may published

Phase confirmatory teprotumumab conducting X in trial are OPTIC. currently a title in for We TED

We expect expect of the quarter -- and September top results enrolment completed in XXXX. in second we line early

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

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

the ways rate While this other the to we of a impressive investigating arthritis, increase are who can for KRYSTEXXA. achieve response complete biological inflammatory with of of number response to types relative is use patients

is company methotrexate. our we sponsored anti-drug different underway, is MIRROR effect are the effectiveness to currently the administration most antibodies. and rate like most methotrexate which trial by response commonly promising by of are Three the There KRYSTEXXA RECIPE, of on by of with the the a KRYSTEXXA evidence the immunomodulators of immunomodulator MIRROR, evaluating that trial immunomodulator, therapies used investigator is rheumatologists as and being response consummating immunomodulator formation decrease work therapy immunogenicity documented the the We evaluating of initiated reduce two evaluating well all rate myself. are on addition the studies used commonly TRIPLE with are of Each immunomodulators studies of rates biological can and of immunomodulator rheumatologists. supporting.

Tim series uncontrolled investigators separate study as centers. As at sequential treated were And by the durability external improve the evaluate very infusion we referenced, by administration to case month gout nine KRYSTEXXA receive at six investigators. Of methotrexate with by uric deciliter of with infusions. milligrams completed response. The at goal three two encouraged The KRYXTEXXA presented all with the ACR of of patients last to serum of during X was of continuing as treatment observation XX% a X period. three were responders additional maintained patients a to more course the X month acid patients patients than KRYSTEXXA less per October defined full X, of than levels the of goal followed,

Following these in six patients promising trial the results, had for support registration. review data first evaluate then to through MIRROR from initially and months we for are to adapting intended our the XX registration. the MIRROR trial potential adapting We

series with at planned year. and discuss in enroll external next continue validation study the to of second presented than potential meeting parallel, study and the In We to moving Given the FDA the earlier initiation the adopt anticipate we forward we in ACR, to quarter registration. MIRROR. are for case protocol from adopted follow the patients will schedule the of

addition, generation for company’s In support with progress that, And continued come. our are the our we Tim with on sustain for now pre-clinical to programs to continuing and for with concluding leadership forward remarks. uncontrolled years future to you look aim I turn progress. to market I'll next the updates over it his gout to

Tim Walbert

Lin. Shao-Lee you, Thank

net and segment of make XX% XX%. continued sales of growth sales KRYSTEXXA segment, sales driven toward to impressive our two significant total long advancements our new net resulting net growth XX% now confidence The we adjusted quarterly guidance third more up In in and net year by deliver and range performance, company EBITDA growth in potential. drivers KRYSTEXXA income. rheumatology our record quarter company. sales its peak another orphan performance that sales, operating for quarter Record record the our data than which term delivered in full was their approximately teprotumumab of on and target reinforce accelerating our summary,

programs. our We continue advance to R&D

ACR presented now clinical trial modifying and registration. MIRROR KRYSTEXXA data new for potential support durability for the that We the teprotumumab supports to we methotrexate, important clinically new measures at Following diplopia. proptosis adopting disease are and presented potential to the and our data in

confirmatory rapid we We teprotumumab. our of XXXX. KRYSTEXXA will in increased enable of in quarter and Additionally, Phase the guidance to enrollment growth drivers, key invest adjusted results trial while the continue significantly second X EBITDA our range

All long-term at generating patients innovative our aimed and delivering and shareholders. of is sustainable Pharma this therapies growth Horizon for to progress

We will call up the now questions. for open

Operator

of Stifel. Annabel from our And line first the Instructions] [Operator with question Samimy comes

Annabel Samimy

sense, mentioned a with us give with usage you this study would whether start that you you've impact Can include be could it and methotrexate the ACR, could your think usage the does driving what not small now, with sufficient of average with peak case series vial the methotrexate recently increased you that magnitude board? had at that per the physicians from vial be right KRYSTEXXA conversations of usage immunomodulator on patient, be with what to do

Tim Walbert

on that all, communicated not meeting. So, aren’t a saw the have complete those first this forecast, is the results, by we if to able and I received increase would so to we of force. trial are our data, MIRROR confirm significant It it was Relative very peak at able promote sales. its impact think sales the able well you to our to be ACR potential in as

results, color certainly we but going through promising, and would be to as my any but clinical per will to increase I get other have we you response it's confirmed as importantly, significantly like new mentioned the trial the rate, ability drive average patients than ability trial. but the data, and -- the you’re double further remarks, it's increase the more MIRROR give to vials patient, if So with for get to, in the

Annabel Samimy

right the is for patients? sense you Do now a have what vial usage of average

Tim Walbert

The X about average is vials.

Annabel Samimy

treatment? the So about half

Shao-Lee Lin

Yeah.

Operator

Goldman our of with next Sachs. line question the comes Dana Flanders And from

Chris Staral

is Staral Dana. This guys. for Hi, on Chris

why some color the And the you ACTIMMUNE of products follow-up think much First then the give biggest a of broad are I as as off, little other after us do potentially drivers that. benefited can may more cross, and portfolio? in a how drivers durable not behind you beta on have here, your have products lot a these

Tim Walbert

Sure.

see PROCYSBI continue those continued across has So, RAVICTI populations. added improvement continued compliance new increase XX% business, acceleration year-over-year. Obviously, to the patients think in and have and I in with we KRYSTEXXA

continues we organization in million that that quarter Our that and to continue. expect drive the XX to business and

our saw businesses that care, our continue. and across of So like to which in we and execution primary I’d revenue solid also and maintenance

think continue XX% So other is grow. to to indications we're and segment it and ACTIMMUNE -- of across is but the we very Relative We to labeled uncontrolled orphan our time. has add and continues is about new patients, business poised at rheumatology pleased you the to that, specifically over XX% to when continue and its of the decline look business. on

disease think good continue business labeled by on the indications and somewhat granulomatous not label we're think seeing we're I in. offset team the So and SMO, of by that think I off to the involved decline chronic in I effort penetration

we've the we're as business very year-over-year to in overall sequential seen it the pleased growth So continue. that with growth as expect and the well

Chris Staral

potentially? it And some being we to those registrational data a then will the and some for to patient you why schedule phase? these at rolled you an why remind have pretreatment burden what could and we change Do get us the what is allow increase that get changes? then be potentially use of those added into can it more in peek data of methotrexate at is maybe And powering the being post exactly set be generated to and might lastly, the MIRROR particularly is point you on in for ahead will the details be not proposed then patients dosing or or think the what to

Tim Walbert

Right.

comfortable very so. using an to continuing can to the average issue the design ACR study used conversation that dose with not the they indicate and would in this speak which with at is presented rheumatologists would RA the our was and rheumatologists at Shao-Lee typical investigators XX the dose, do approximately milligrams in point. methotrexate So are have

Shao-Lee Lin

that, Yeah. Thanks for Time.

with or support to that likely require we methotrexate. registration, order evaluating in without KRYSTEXXA think So we’ll

study determine controlled to agency a we'll conversations able best we’d forward move be placebo the better be how that with to ultimately speak and at ultimately to and time. to will that So have

Operator

line question with Amsellem And comes the of our David next from Piper Jaffray.

David Amsellem

secondly, up and in at so in couple in are discussions how with agents, sales combination methotrexate or immune-modulatory planning this run help my this come getting with but you're you azathioprine whether ones And I nephrologists. regarding has the relatively coming efforts of but have to and growth it's immune-modulatory the other know looking XXXX? whether rheumatologists, but or studies from early it's combinations, about Just agents, KRYSTEXXA, broadly the safety of how a on may impairment buy-in can talk patients CKD you of can, it's I to if of quick better dosing your missed you much earlier, in just us combination. you marketing tease can be now way then setting, context to of the understand from that much specifically setting and just renal what relative or that and KRYSTEXXA right the immune-modulatory the even is proper nephrology in out maybe could sort a the in with agents in as more talk the

just us you planned So understand what help subpopulation? within that have

Tim Walbert

to basis strong it a speak splits want you to continue First to we a don't to on methotrexate combination Shao-Lee and grow. break a to nephrology, subpopulations, we sequential in basis. to year-over-year that? down the continue certainly on growth and We expect with see Relative and

Shao-Lee Lin

Yeah.

well. actually said nephrologists commonly the trials, commonly by used is the excluding methotrexate rheumatologists. not most of So [indiscernible] by as and used within immune-modulator we’re our chronic patients certainly quite kidney we context clinical with disease

on as things that go, stations that the That within our part patients have chronic these said, we So have tend these this the in kidney of that disease why of we we'll of likelihood of and groups effect interest those get studies two well disease such it and the in we we nephrologist of to that efficacy. kidney regardless the physician any actually with remind covered trials that pivotal think the the as stage XX% you were of the context migrate have seem of had, subjects context didn't to with towards trials. the that within some I'll terms think of that the

of that's Maybe, you part specific have comments? So, Vikram, do it. any

Vikram Karnani

Yeah.

earlier, Nephrology in weeks color nephrologists just think session. activity American in provide was Society we of we to participation couple the our this saw during interest commercial a meeting room our ago. some that a the just clinical said more tremendous. the have but I symposium on XXX extremely with at of may strong was It standing attended booth only than The nephrology,

fact, we from meeting we're positive indicator And time now. to grow intent where should we expected feedback year-over-year, spoken In point be. are with which we for continued we've to to leading receive in which as XX% our this at significantly, the probably is in investigation, continued prescribe, even but benefits before, that only about line right at

our in So all signs is expectations. nephrology There are very on to track positive. -- we're right

Operator

Cantor with comes And line Fitzgerald. of the Chen our from next Louise question

Louise Chen

KRYSTEXXA guidance I we in think give are for you of to things? products think is how how the second your next update recently, gout won't some and if trials you products give it? this probably could opportunity the value just that you if KRYXTEXXA product the thoughts asked market question data head on will grow you any these then but should and Do XXXX. And for generation franchise, for And an absolute a first just I product, your it fit into and approved? know curious if we was, had have they’re qualitatively here, So I lot, question in any on something basis will that for last get on development, head came an had competition was is which out year-over-year? potential the about about that on these sales question

Tim Walbert

back in that assume trial did relative developed at include XXX did I’ll our market. we competitor estimate would not Sure. least MIRROR only the potential, of its end, benefit we When the we come peak start to million, the one not sales with of on competition.

impacts with So have as from digit guidance. percentage we we're impact KRYSTEXXA, ability that Despite double giving the sales. with on Relative we achieve KRYSTEXXA don't that of our see rule that a as of XXXX, our implementation having There changes do in and XXXX been reimbursement minimum. not to potentially, expect KRYSTEXXA any specific to reported some peak growth that sales. impact from a

Tina Ventura

Shao-Lee, if you want program? to address nextgen the

Shao-Lee Lin

Yeah. question. Thanks, Louise asking that for

immunogenicity designed So more fix are address same programs KRYSTEXXA that broadly is which uricase. generation to of we're recall itself, the with with next problems trying our the that immuno-modulators pegylated the really to just

well whether they that and not for as so patient programs add or in developed And optimized think immune the immunogenicity programs. itself, half-life that's the Both as an sequences a can have that convenience Recall have they’re become called new evaluating is generation to minimize you uricase preclinical well updates them pegylation, immunogenicity. future. next so an developed we of also X nicely additional are from which prolong is being available subcu shield as we sequence the [indiscernible] as optimized that’s juncture. progressing one are will system at we'll or to and the Both from technology once of patients to amino acid as uricase shield this to actually foreign both different other two protein an it these are determine also and being formulations, the we oral technologies anticipate

Operator

Company. And line and question of from Cowen with Cacciatore comes our next Ken the

Ken Cacciatore

question a development. Just on business

called BD just earlier there, in update changed of you out continue then valuations and of approaching with if development allowing that business with you have later to thinking the to tepro big release. of your maybe seem strategy, the part earlier to in still go out it you're you're past. and knocked company, assets, the seeing have stage into to not but assets it's the a on it's stage evolution look on you how is if us you just Is kind I can what are BD? know, how I I’m You the forehead wondering hopeful success of, press the my just here. well going of it the evolution of remembering

Tim Walbert

Robert?

Bob Carey

and that continue to a Ken, see interest us. Sure. are we Thanks, to Ken. opportunities of range assets of

attractive. biotech for of and actionable some stocks, mentioned think closely at seeing internal what's market that we're opportunities obviously, it the impacts analyses, attractive an been watching our the values are valuation, market in still You are we're but face that we own

world to in of her. Regarding do and development and addition class to level go as research a we're able earlier going success have the refocused we’ve as than stage been whether into of to later, in our of assumed opportunities recruited go what that to And tepro, approach is able she’s talent our Shao-Lee we're result group a result pretty development work that, a different with whether the allows efforts that to of the at us we programs or of with past. interrogate significantly

that marketplace in sense really So that pre-clinical ourselves understand that to gout because as in that franchise, where us made ability behind we HZN-XXX technology possible find could and a having we it's the we went to with we areas of earlier, go did it. our

tepro. It’s what However, had we that after, thumb, for for data think model as I we HZN-XXX. with more humans rule see concept is that go of of going model proof with programs the probably which a you we're in look the to the that

Operator

our And from of question Koffler with line comes the Mizuho. Irina next

Irina Koffler

just two. had I

KRYSTEXXA and work there then of patients question work is the of need reporting earnings in other gross the wondering if for also just some adjustments to that setting patient in you Was this to later? And the or net would that any a companies clinical you're that quarter in terms doing from we've additional like KRYSTEXXA are population population, promote second transplant related. stocking -- one-time seeing any to having on any if conduct it there you as been quarter? of lot choose gout exploring guys KRYSTEXXA You in

Tim Walbert

Paul, do want to you take?

Paul Hoelscher

our our where inventory business, the than in been is remain we've across less with levels month, a mean, inventory which consistent including past. KRYSTEXXA, levels I our

Tim Walbert

I transplant, to at think know on then want don't data clinical And this don’t Shao-Lee, we have any in you if time. point I --

Shao-Lee Lin

specifically of degree lead lot the in gout No. the setting, don't at have therefore potential flares. know of as a worsening seen high lot There's transplant the uric gout can clinical any that data within of even ultimately acid certainly for that’s transplant We context medications especially of to the transplant probably of in and we depletion general point interest community in because time. both nephrologists this as a the of well of,

excrete action the uricase. that attractive to One things of turns the to in mechanism excreted nephrologists is difficult the to kidney soluble completely KRYSTEXXA something Ultimately, something of the simply by of and is about it water is easily that urine.

mortality kidney that, can evolving think a juncture, terms systemic there's as to lot a whether from deposits as watch also I nephrologists the gout organ think of of about a of hyperuricemia where hyperuricemia treat chronic I disease, to well desk. grow. hyperuricemia in analyses continue bottom effect, these happen question, of So And and that the enthusiasm to and of system, this We've the med you setting the seen analyses. a interest even in or the if the years because at crystal a story data med area couple you couple evaluations whole, the from within a as will the last a specific is any leading the with on of impact regards academic egg think I continues all-cause open systemic to evolve. to disease disease. the Ultimately, that the in body in in then how an can see of even kidney We're as context lot nephrologists protective line or cardiovascular still chicken it's of it's seeing of as

come. there's more to an think and to going it's I be So evolving field

Operator

comes from Capital next question Gary BMO our of Nachman with line And the Markets.

Gary Nachman

will out we've standpoint, building there? promote many Thanks. primary from out indication phase XX some you maintenance to that claim would commercial on initial of the X the positive, the if a that bring the reps go at teprotumumab, capability? And are you're a board endpoint seen about weeks, you or after out data to how then thinking be just On look for also just additional the just you commercial given us XX-week that how XX will or data results this tell for product,

Tim Walbert

Sure.

on data Based monitor and primary our disease. that OPTIC-X pivotal eye submit We and weeks, phase trial of and for will on is outcome X subsequent a with XX treatment of the from the the basis. that will submit success phase thyroid X programs, assuming

I surgeons as through my and of of, and the As process remarks, as to the working role is endocrinologists, plans mentioned number what in critical in our around ophthalmologists, really determining of plastic far reps, the ocular determine we’re finalizing strategy. best commercial

forward, once move fully we So our commercial and data communicating and through we'll get strategy. begin understanding

Gary Nachman

And update get year, XXXB next expect you give still go confirm us about zero, on the that XX% exposure? double that if digits follow an would I on with I you change. just just to of that want KRYSTEXXA, even just XX%, said to a very up probably quick to grow could it's sales close

Tim Walbert

Correct.

Operator

our And David line Stanley. Risinger from the of question Morgan next comes with

David Risinger

the more forward questions. file that the you It financial should bit the timing and on you that. And you then sounds be? on to movement two conviction just be congrats pretty So MIRROR. of Paul, level a news compelling so might your Could filing on provide for do potentially that of color little can what able just

if below the just the to growth. growth call, if missed if part accrual I you respect had them volume reversals, care? and don't sales quantify so, with know primary of you KRYSTEXXA, could explain bit being I a and the for you then First, And could little if any

I and XX%. vials think XX% sales around up your figures were up

Tim Walbert

take me quarter on maybe, XXXB. that expect go through certainly Paul high-XXs care to fourth maintain we our growth. the primary to first see will question We Shao-Lee you one change vial address and Let – want we the us the with gross do to to the and will the implementation on And that net and in then of the

Paul Hoelscher

quarter nothing specific the is or the way the impacting on There one Yeah. sales. accruals in other

Shao-Lee Lin

then for as and by earlier, we're level the comments our in filing, methotrexate very that regards so encouraged confidence I in to stated data. And with plus we think potential these KRYSTEXXA data

As are is I X be event were these if patients in less were the random that responders can selected, these calculate that centers will, you these evaluated X if mentioned, than non-randomly you this and sequential likelihood is X%. get if of -- that to to patients sequential you sort a

MIRROR results our for seen is this KRYSTEXXA reason significant the confidence that to our adapt and the So, early. therefore move study our in we've

ultimately, require KRYSTEXXA said, this I -- plus the we As for or think registration that will methotrexate. will minus potential

So conversations inform trial, FDA now controlled that that those what ultimately be planning requirements the and we’re and enable to the will that placebo label update. will we'll for be but design with better what have will

Tim Walbert

we’ll timelines that Yeah. be take and to that And once them better have project continue we we'll information, able to at point.

Shao-Lee Lin

used methotrexate there is are by available important that one now. points both think of commonly and most the is rheumatologists. I KRYSTEXXA Methotrexate

out external decide them. this to there, it's ultimately is put with so patients and to the the at to meaningful physicians this And been that's point up data the if

Tina Ventura

call looks morning. And our this that to be last

in So so replay this thank you much so this A approximately call webcast much. thank and X for us joining and you morning. will hours available of be

Operator

Thank you, participating Everyone, wonderful for may you program and disconnect. have in does conference. all a ladies today's and gentlemen. conclude This you today's day. Thank

Horizon Therapeutics Public (HZNP) 7 Nov 182018 Q3 Earnings call transcript