HZNP - Earnings call transcript Q1 2021 | Horizon Therapeutics Public Ltd Co

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Operator

Good morning and thank you for standing by, and welcome to the Horizon Therapeutics PLC First Quarter 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 of Investor Relations.

Tina Ventura

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

Executive today Walbert, who Paul financial our and a Chairman, the Liz Executive then call Officer. and provide Andy Tim will will me and with review Thompson, performance. R&D followed Officer; more closing President, Financial Officer; quarter On Pasternak, programs, President Executive and Liz Chief are detail. Chief of our questions. provide President, the we’ll remarks Chief first President, business, will by Vice Vice in guidance Research Vice Strategy Development; from Hoelscher, Paul, Tim review performance take including of discuss our After a Executive your Tim,

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

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

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

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

Tim Walbert

good Tina, and you, Thank morning, everyone.

one achievements was Horizon. multiple quarter first with The for

biologics as in a a March now that last our for to have of TEPEZZA. R&D Viela acquisition adding of advancing the We mid-April scheduled of and process development pipeline, manufacturing rare receiving total the year. UPLIZNA. orders. high-growth was in for trials mid-stage supply our biologic which We early-stage the diversifying in increased TEPEZZA This with research, start expanding XX after began by biotech the disruption particularly FDA December, relaunch portfolio COVID-XX the our disease eight result completed of mandated position approval a scale our in capabilities, deep, programs this including followed we the on-market vaccine First, pipeline, U.S.-government initiated Bio, the temporary

advancing are expansion announcement We our of in Europe, plan to first today’s UPLIZNA our global build our European We out anticipate with strategy the of approval launch XXXX. approved. quarter if in to infrastructure

additional establishing introducing KRYSTEXXA, includes well medicines States, made and platform strategy United well. Japan TEPEZZA our from medicines outside We markets, here other progress for as expansion geographic launch we significant future and ACTIMMUNE. disease Our a strong as orphan the of in PROCYSBI the growth generated RAVICTI, as

of with expanded R&D the and awards Starting capabilities therapeutic our Biopharma Best on its We ranking, and number since in of competitive on in strong which our aligned across three and one diseases. the inflammatory and deep the and Viela, tribute this the translational focus. also to its of team and with the programs development phases to ability Viela’s received its areas Places all autoimmune in early-stage start and four strong list; highly nine innovate enhances engagement knowledge multiple number company research us clinical talent strategically with Fortune’s hiring prestigious ranking in the broad and retaining considerably employees highest-ranked the biopharma including Fortune’s Top XXX year, our biologics, severe important experience a our factor Places sector. an biotech to of scientific brought is development, Work in best-workplace candidates of XXXX, pipeline

of medicine neuromyelitis biologic rare optica the spectrum or on-market the disease with portfolio UPLIZNA, our disorder infused addition diversifies NMOSD. for an medicine acquisition the Finally, indicated

to Horizon. successfully the finalized integrate and brings the by morning rolled impressed teams acquisition been Viela together mid-March, and our in talent companies, expertise Since our been this two have out to organization. have completing We the integrated and we team working the fully

We portfolio maximize potential. refining development the to advancing strategy Viela for its and are our

priority the UPLIZNA the for B-cell pathogenesis include United vision, the a loss in by a of successfully play failure. June commercial the to and relaunch launch critical UPLIZNA NMOSD, approved as the patients and cells is potential relapsing, brain approach Europe. for near-term stem. the FDA rare, preferred that was relaunch we first and role only This optic disease last and of Our during expanding full is the and commercial including and organization. depletion are year pandemic of of of for medicine, the adult planning NMOSD relatively of B nerve, prepare disease launched by in UPLIZNA resources, a Manifestations paralysis NMOSD. also size was the Because a in respiratory the mechanistic with in of spinal the the autoimmune physicians. minimal attacks severe, B-cell the treatment depleter neuroinflammatory cord with is States

applying that to ensure component launch field-based is the We teams A support for optimal key UPLIZNA. successful in the relaunch of strategy strategies key invest are we to from KRYSTEXXA. to and used learnings and TEPEZZA marketing

accelerate We we the and year. second the are of in well preparations our on efforts way expect move the our of to half results as our relaunch throughout

adding to as teams adding site include, services, which representatives next KRYSTEXXA, patient in opportunity and to pull-through, and critical is infused our optimize care the success we rare to of NMOSD; of know from Our comprehensive applying patient TEPEZZA payer for and the medicines. sales steps disease maximize UPLIZNA support

patients in challenge network its early was UPLIZNA a to in leveraging are particular physicians referring of launch. which also We our for site extensive centers, TEPEZZA their to infusion care support

includes clinical treating the presented an discuss scientific to is medical as of NMOSD. at this meetings, core further real-world leadership programs evidence medical physicians our of to engagement it at Important collaborate establish example scientific to to and UPLIZNA supporting a in in base Keys UPLIZNA. key as two we to new our of data more ensuring recently clinical were We strategy strategy how medical conducting investing compelling medicines. how type Horizon executed of well KRYSTEXXA This with of use are clinical This analysis Liz benefits understanding that analysis differentiation, UPLIZNA engage, is its aware in and the are will community. strategy. and is have to which of build commercial continuing of expand differentiated other and successfully educate affairs the detail. are the from on-market of

disease. CDXX autoantibodies see rituximab targeting rituximab, that distinction chimeric cells, does is not we the for is plasma antibody secreted plasmablasts UPLIZNA important and medicine or is cells off-label example, UPLIZNA lack of these UPLIZNA monoclonal differentiate humanized In multiple been NMOSD, NMOSD which CDXX the One molecule a devastating that given receptor, receptor, approved plasmablasts. depletes has to pathogenic an by For treat treatment used are an to plasma while opportunities from this and a targeting cells. the deplete

Additionally, relatively convenience, well-understood reactions, UPLIZNA low of and also infusion with Other prescribing antibodies data its favorable has shown mechanism action. efficacy. physicians, UPLIZNA a long-term benefits anti-drug safety are recent rate confirming including its of profile of with and resonating

of progressive only Moving to Thyroid is the a autoimmune and approved rare TEPEZZA. serious, Disease, for Eye is treatment the medicine which disease. TEPEZZA vision-threatening

pandemic. government-mandated the of December. drug disruption to temporary were COVID-XX in the with Catalent. aware, was a this and third-party throughout you are This due at we challenging TEPEZZA and and of vaccine U.S. We lives This end how our product to COVID-XX physicians, our save supply quarter critical treating first for certainly to no manufacturer, very business. As end orders hopefully was was since TEPEZZA production accelerate understand for it supply patients vaccine

We in change FDA we allowed the in many a mid-April. begun manufacturing also Fortunately, a manufacturing vials in approval us were process of prior finish to announced to and supplement manufacture This had and FDA supplement approval the more This scale we with pleased of and increase announce fill resupply we each scale that submitted early last the which required year January we could TEPEZZA Catalent. run. March, new increased with to FDA. at approval vials already to

White with difficult very TED who this treatment for situation the to their had live patients of debilitating of While to been middle and the the continue and TEPEZZA quickly stop certainly with as has resupply us the in possible. approval a expedite the as patients incredible Catalent effects for we FDA and TEPEZZA to commitment to from work TED, FDA, HHS, appreciate House

been of for new production expand this supply overwhelmingly pleased manufacturer help with on have the progress now, the so resume approval are has the product their therapy, get we far. make at and progress we Patients with adding weeks increased-scale to by start obtaining two drug to to strategy end addition feedback our TEPEZZA eager are seen. The treatment. been for about year. Catalent, has and them a includes to second physicians continue are capacity, In to reengaging on extremely or patients positive available which we

about who on launch, the have types physician are are making resume already time. disrupted due We their had but patients first patients and half early in our we patients built majority were thankful since expect have patient and in various communities stop research have their TEPEZZA great disrupted to resume therapy, Based are about seen treatment scheduled TED they patients we’ve supply to strong the disrupted on have patients channels of TEPEZZA huge many are difference lives. disrupted deeply supply during progress TEPEZZA; patients, again. patients conducted social starting shortage, To-date, making we vast relaunch. new now and to who how posted shortage; of a is the therapy. now As two the treatment to infusions. With for on of we starting who on the

job patient up continue we their team as only provider. patient, to physician journey. to for remaining expected. do are scheduled. to patient incredible scheduling depending happening we’re While and their TEPEZZA continues The each their take and to a planned treatment weeks this, re-verification throughout the our process The is We on communicating that move in, get and months evidence through processes with their an services disrupted few seeing this can patients insurance two the

we with the encouraged in seen have very are first weeks. We few the progress

regional that expanded acceleration number the PEF of demand of have continued of growth, customers. new an strong team our seen in drive and Since and resupply mentioned at frequently This managers care new completed forms medical despite of our their reimbursement week. representatives, announcement to at to we during addition year, or supply as saw PEFs. enrollment of the the of earning’s patient continued We continued organization Regarding end last last on quarter TEPEZZA field-based I the of growth which sales patient expansion included disruption, promote February, commercial our TEPEZZA fourth prescribers patients, the access liaisons. impressive site TEPEZZA call and each in are the March, we an with for patients communicating new liaisons, liaisons, and the end disruption, prescribing

at monthly high number In in the our end increased fact, February, last the for significantly, and since we PEFs an April. update total of total has PEFs of all-time hit

a good and We have their generated number of first already first year, whose new fourth seen this quarter of the PEFs patients, infusion. scheduled in were

quarterly patients the progression, the the and the new TEPEZZA’s disrupted quarter net treatment, of we resuming we have unique work in adding net an along first year and be third relaunch highest While unusual this disrupted sales of This accumulation patients. occurring with quarters, through sales expected we with treating generated as accumulated quarter fourth to patients PEFs as result the dynamic in new TEPEZZA. will a

quarter, year, and patients we of and connection including those disease, to significantly treatment. investment TEPEZZA and but this speed drive TED, Graves’ As awareness increase to not also to the diagnosis to we said, Graves’ of only the between targeting have first TED increasing are in TED with and awareness the our TEPEZZA, raise in

websites patients that addition Our unbranded on for we we for direct-to-consumer campaign, supply TEPEZZA, last campaign, search temporary campaign disruption. quickly. Monday, to our reach treatment television awareness resuming branded TED also the first motivating highly seek the to as expect successful, during to broader our which and and year television more by TED to and in was TEPEZZA TEPEZZA launched TED patients fact even drive On continued unbranded television the evidenced specialists

progress campaigns, billion. and We XXXX through campaigns which guidance more toward year, national rest our than of uptake sales new are to run drive of we DTC $X.XXX net the the expect the TEPEZZA as increased of will TEPEZZA

prospects sales and than in net global We are continue expect for confident growth peak $X.X to TEPEZZA annual of billion. more the highly

as studies in physicians trial On mid-year. the begin to TEPEZZA we continue chronic see our development front, well clinical used in expect in case In to patients at meantime, we of presentations patients who data their have TED TED as enrollment medical treating published positive chronic the by meetings.

year emerge KRYSTEXXA, million, We with net expect ongoing of reported increase the more prior sales this COVID-XX. quarter XX% the With first to throughout versus data of an $XXX continue to associated year. we challenges despite

we of among of for the KRYSTEXXA visits are increased plus attribute this sales increasingly of KRYSTEXXA levels physicians We we become calls since new the for see higher of patient pandemic. between Key are to plus seen well increase to We strategy, number conviction our of significantly who and to aware response KRYSTEXXA clinical as immunomodulators. to use of immunomodulation immunomodulation. XX% with in highest as co-prescribe alone; immunomodulators have compared success encouraged KRYSTEXXA a the patients by team XX% higher KRYSTEXXA now recent using physicians rate of to by continue as the in-person rheumatologists, immunomodulation our the is KRYSTEXXA and long-term onset

KRYSTEXXA strong of for $XXX this more more full-year $X net of supports net sales year, is it also with annual again working, and sales expectation million. supports than estimate our growth peak our than U.S. for guidance strategy XXXX It Our billion.

Our and in quarter, growth disease high the over compliance now will and the of I RAVICTI, first ACTIMMUNE, to adherence. shipping all growth Liz. strong by active turn continued PROCYSBI driven durable patient rare call generated medicines, rates and

Liz Thompson

everyone. morning, good and Tim, you, Thank

the talent patients. The first been organization team, their quarter science across acquisition commitment began the of the and was as a the two completed impressed landmark integrating and for quarter the Viela with have deep to I organizations. R&D Viela and we

breadth and Our pipeline now significant has depth.

from spanning preclinical six mentioned, and in X. post-marketing trials we in cycle the life X programs XX Tim X, seven have two with to development Phase in Phase As Phase

anti-aquaporin-X the important will that cells. year this by approved patients start information. last only was on increase adult anti-CDXX antibody I Given call B UPLIZNA, for with with and on new B-cell humanized will key depletes calls with scope, in and this FDA future the first of and monoclonal NMOSD. is and the I our focus depleter programs It treatment those antibody-positive

referenced, As treating neurologists approach is in mechanistic with depletion that Tim very disease. a b-cell familiar are the

for to previously presented priorities Americas the abstracts analysis were with data from may in in with qualified is Multiple experienced UPLIZNA scientific to efficacy One exposure, of Sclerosis had UPLIZNA with including its an in robust patients the very continue previous treated of had XXXX our Forum. NMOSD. those have attack during UPLIZNA body role patients the Research rituximab, with the February for supporting study Committee and of safety relapses. data Of in highlighted who We rituximab that period. as none to build NMOSD four seven after the evidence important Treatment a and suggesting pleased One UPLIZNA benefit patients treatment who rituximab failures, at

provided was X and sustained new NMOSD a attack the data from from American UPLIZNA of in Academy of treatment risk patients. Annual data for extension generally well-tolerated open-label the in UPLIZNA end-of-study We four at Neurology including pivotal April, period the Phase also years, Meeting long-term baseline. least in presented at NMOSD trial reduction

X UPLIZNA in patients published the new UPLIZNA & disability issue Neuroimmunology NMOSD. data analysis in reduces May of that Finally, was Neuroinflammation of the with Neurology indicating of risk Phase a worsening

this which disability, As physician meaningful a progressive attack damage is each further data could these to disease causes and the community. in be

disease kidneys. our selective salivary oral signs that causes early HZN-XXX systemic antagonist has neuromuscular autoimmune Moving or marked We shown especially these as on MG in body, is swelling Enrollment chronic, disease. of is impact control refers UPLIZNA glands the often group has X limbs. are Diffuse is by to HZN-XXX, disease in a trials rare, such the mouth, voluntary LPARX mortality of autoimmune MG a and of chronic, programs, damage and the tumor-like organ affects disease. a pancreas, internal to fibrotic ongoing. organs, evaluating disorder and two including gravis of myasthenia in clinical and and that a the IgGX-related eyes, rare affected muscles IgGX-related disorders sclerosis throat cutaneous also Phase fibrosis rate. those that high that progressive

enroll this Given cutaneous track second no first in the our significant disease medical Xb trial patients FDA-approved pivotal Phase We XXXX. patient systemic on to for treatments need. quarter today, sclerosis unmet the remain diffuse a of presents in

trial pivotal most median a interstitial lung survival disease. in common Phase with is IPF, pulmonary disease five a is HZN-XXX fibrosis the second Xb idiopathic lung Our rare, than or of less IPF years. progressive

and a FVC While in is inflammation current capacity drive treatments or in fibrosis one-year effectiveness approximately lung disease disease that patients, a will assess comprehensive trial addresses treatment. the expect change do lung years, measures begin weeks. forced the the the to capacity, slow expect which progression, XXXX. may endpoint, stabilize and be approximately unmet FVC, need progression data that not we expected objective for they for endpoint the to in the that is There take significant the IPF. to is is XXX a and after primary used Target enrollment mid-XXXX, an XX vital Enrollment, endpoint and of disease. we treatment of two with

autoimmune is receptor pDCs, causing arthritis antibody as on studies conditions. in monoclonal as cycle glands, that as that to the CDXX Sjögren’s condition cell chronic, damage diseases currently HZN-XXXX T systemic the tissue cell-surface thereby with transplant ILTX, syndrome, dendritic that of indications pathway. inflammation of including other Phase CDXX-expressing salivary to B blocks human co-stimulatory overactivation, Moving pDC that X address disrupting impacts causes thereby called plasmacytoid a rejection. interrupt and a this cells and the immune autoimmune well in binds CDXX cells, development HZN-XXXX lupus the ligand for or is may that depletion ongoing exocrine tear is ligand antagonist kidney depletion. glands, in HZN-XXXX, including interaction a a and rheumatoid pDC overactivation such

track systemic SLE For our first in erythematosus HZN-XXXX, mid-year. trial are to patient lupus our enroll Phase on we X or

trial compared reducing expect that placebo effect disease lupus outcomes. enroll XXX BICLA. HZN-XXXX is of in be We measures evaluate participants. to approximately with BICLA endpoint primary SLE using The the will the commonly of index used a to activity

also successfully trial data in HZN-XXXX trial, lupus end at medical as reduction of a CLASI-A, year. with late-breaking of trial. in a be a presented secondary this of to A last X Rheumatology endpoint lupus or available which was significant conducted American College in treated at the expect cutaneous measure a erythematosus Phase clinical X abstract patients We results with cutaneous clinically is the meeting In saw XXXX. CLE, our in Phase lesions,

we chronic placebo-controlled in mid-year. to TEPEZZA, Moving trial expect our begin patients TED to

Given inform Target TEPEZZA covers TED indication study population, approximately is that generate enrollment chronic change trial to Week randomized proptosis the broad in in had chronic patient TED who better eye TEPEZZA payers X:X the about to the patients. clinical objective the TED less endpoint five XX primary is and for physicians the in is from of the years use of or have baseline ratio. the a patients The XX. at in data

the the TEPEZZA. with ongoing; for data additional including of will work approval. once work collected clinical define be We includes which information completed Phase mid-XXXX. our and drug-delivery analyzed we Follow-up X TEPEZZA have we administration available in initial is trial, data, dosing recently subcutaneous our In formulation an subcutaneous pharmacokinetic follow-up expect Halozyme to for required a technology ENHANZE FDA to line for in top of the program, data package, patients the evaluation we these

having initial We Pharmaceuticals with discussions completed advance our for in positive also continued and to Japan’s Devices TEPEZZA Agency. Japan, Medical program clinical

increasing the R&D three patients gout; complete we progressing rate; the the is improving experience. aim continued more value the our trial response with maximize benefiting Each KRYSTEXXA, patient which well. advance five to of ways: medicine For and in uncontrolled to programs,

in fourth from We continue trial placebo-controlled MIRROR XXXX. expect the readout quarter to of our

controlled the others MIRROR, KRYSTEXXA Beyond to using mycophenolate published use were literature Rheumatology RECIPE, case, mofetil. to with and first in clinical in this KRYSTEXXA with regarding of randomized we Arthritis immunomodulation. from an published trial & Data contribute immunomodulator; continue recently the

turn KRYSTEXXA. the our enrolled and in call the on our you patient I first we updating March progress, regimen I in monthly to of over a Paul. will forward trial Finally, evaluating to continued look dosing

Paul Hoelscher

will morning Thanks, Liz. otherwise unless primarily My this on non-GAAP our noted. results, focus comments

are We of given our very the significant the performance in with supply impact disruption. overall quarter, temporary pleased the TEPEZZA

sales net million. $XXX First-quarter were

million, net million. increase segment the and generated driven million, segment inflammation of Our performance of $XXX strong income orphan year-over-year ACTIMMUNE. KRYSTEXXA, $XX by and a segment was PROCYSBI for Net were of operating sales RAVICTI, sales X%, $XX

We cash our the into from expanding generated and continue flow to segment growth pipeline. reinvest our this drivers

Non-GAAP non-GAAP ratio non-GAAP gross line expense included million, SG&A both $XXX Our were in $XX first-quarter our non-GAAP million was sales. of million. profit with operating $XXX expense net XX% of of R&D This and expectations. expenses

$XX was was tax impacted EBITDA the were for high unusually non-GAAP $XX adjusted We in million. Non-GAAP tax First-quarter the million. quarter income by an expense first rate quarter.

in in can tax our seen prior quarters. across we’ve rate variability As years, there be

second, to our shares We The third tax in double-digits. were low calculate rates per $X to EPS, million first-quarter and quarter diluted shares. non-GAAP XXX million rate fourth-quarter diluted the were $X.XX. the first expect weighted XXXX of bring average to expectations non-GAAP share full-year with outstanding, tax the and was used in income offset the quarter line net Non-GAAP earnings

cash operating flow $XX non-GAAP million. was First-quarter

Viela, equivalents The significant $X.X the as us As following execute of in us XX, is and principal additional flexibility well cash pipeline acquisition billion, of giving to million, in of operations, and our other amount pipeline allowing further were transactions. debt XXXX. as strategic growing with our invest March our maturity earliest to $XXX total indications including cash expand the

ratio March leverage as adjusted times gross is X.X Our EBITDA debt-to-last-XX-months XX. of

Turning the full-year now are XXXX the impact updating guidance XXXX guidance, incorporate of Viela our acquired full-year to we our to business.

billion. the full-year to sales of net billion, in in billion the $X.XX adjusted $X.XX billion to and range of expect EBITDA range $X.XX We $X.XX

full-year net expect more year-over-year to growth than XX%. sales of continue $X.XXX of representing than XXXX greater we billion, TEPEZZA, For

at expected quarter patients the be net year. third highest therapy, dynamic we an quarter quarterly disrupted to sales unusual the mentioned, Tim unique same resuming patients net the given are new of time progression, As expect of the sales the starting both treatment with

growth sales for net million strong of more XX%. than year-over-year expect than the to more of year, continue $XXX representing we KRYSTEXXA, For

ratio We full for profit non-GAAP expect between be XX% gross our continue to XX%. the year and to

a adjusted R&D in more be Viela for programs, triple investments expectations XXXX than clinical TEPEZZA reflect HZN-XXX, R&D of our our we significant our the spend. to amount and in updated programs, XXXX increase the legacy and expect Our KRYSTEXXA expense EBITDA R&D expense. Incorporating

fund we of non-GAAP Viela issuance net now year approximately acquisition, to full million. debt expect interest the for additional the expense $XX be the Following to

to rate the or divestitures expect his any non-GAAP that rate double-digits. significantly million for full continue make will XXX may We be We any concluding as as remarks. tax diluted in in our I turn a the We count the average XXXX year could full-year And now in be expect always, cash tax change be our estimate to low changes acquisitions high result or rates single-digits of in XXXX. that, to over approximately shares. we share it Tim tax will laws. to weighted With our tax

Tim Walbert

TEPEZZA this of progress Viela, accelerates eight result situation. our We given Thank that a XX of pipeline program TEPEZZA strategy year. in relaunch Catalent, for Paul. challenges the and very and growth. disease first FDA, this continued. able the medicine, pleased are with global in advanced programs House TEPEZZA beginning were for to We long-term build April, collaboration the completed were of as quarter, and get the had patients acquisition with generated to launch the one our medicines. the from of the HHS, very and our it in possible clinical the now the TED for rare we the we which White many have access only supply making and expand for COVID-XX We to strategy once impact We for the disease. expansion with approved UPLIZNA sustainable development, KRYSTEXXA our with pleased our for NMOSD, again this preparations continued which the were We treatment from of We Europe short-term Japan in performance in debilitating results the you, to with other potential from strong

on just in increasing progress years and in to the both well-positioned year very our relaunch remain new value believe to the also early this with we in, pleased and progress We and two are continued uptake. deliver are focused patients with We disrupted driving ahead. shareholders weeks driving

We for will the call now open questions. up

Operator

from question Thank [Operator from And Amsellem our you. Instructions] Piper comes Sandler. first David

open. line now Your is

David Amsellem

Thanks.

Tim Walbert

David. Hi,

David Amsellem

Hey, good morning.

Just a of couple quick ones.

cadence mistaken the watermark TEPEZZA, not So you about being in high year. terms of talked XQ, for the the if I’m for

deeply. Thanks. conventional like thought Just process of I’m secondly pace sort away just wouldn’t forms will the help the growth patient of you’re I’m the time? year? us understand XQ it about thinking for the the of why with you’re demand sort more you about watermark watermark? And high how of in with azathioprine then growing, switching from in just if the enrollment that XQ and clearing overall the over just wondering thinking extent the in being a on results be how high backlog, So UPLIZNA, Is interested and away immunosuppressants switching of rituximab from

Tim Walbert

Sure.

commentary on TEPEZZA your spot gating. with You’re around David

to So didn’t patients And the we first quarter. also of fourth disrupted had that then the accumulating the get you that quarter in treated patients. PEFs and number significant add

a number on significant only second the of they April. a where sequencing essentially PEFs treated as part well be month have quarters would disrupted all patients, third for So of half most as and you in quarters two a with the of

bolus quarter. you significant and when look vials, less will initial third the all up through that clear add dosing drives that So a being that in at you

drive growth is been what’s half a this from paths, that is currently rituximab in to disease. certainly as to we since versus well-positioned new especially drive did in is not the have UPLIZNA think there’s which About extensively approved, UPLIZNA, And switches. rituximab, for And point of ongoing to that commentary we number opportunities TEPEZZA. be key our lot driving good factors. which but used that patients U.S. of continue we’ll Relative So around of on. we the there’s a launch

and all, treated. level There us the of the right the commercial our wasn’t to ensure care only patients had through of of right right right-sized. access, First patient we’re not we organization but for significant these getting pull to get that a or organization place site services

certainly So rituximab, adding talk big of exist a us UPLIZNA think will launch drive services as we they’re UPLIZNA the of advantages which and about versus the difference those in uptake. We help weren’t make significant. we

confirms First immune of humanized responses less can we has long-term infusion fully versus had all, have data presented, These antibodies. impact seen UPLIZNA is recent for less We’ve tolerability with lower all inducing humans. anti-drug efficacy. the risk in reactions, which chimeric, which And and which long-term rituximab, there’s antibodies, efficacy. human that

that target of UPLIZNA see see as certainly B potentially more versus our lead we we rituximab, hitting So cells as a advantage. which an with to effectiveness. CDXX broader And also could array

add rituximab you not patient to is off-label, fact that not support. there’s it’s and So promoted, the

co-pay support and where understand treated. the just and commercial for treatment patients disease, to So get helping best the patients overall

So the we as switching opportunities but from scale a commercial really we us becoming treatment. for establish lot on organization, right ultimately of long-term rituximab first-line the there’s and of think level our messaging

Tina Ventura

Thanks, David.

please. question, next Justin,

Operator

And next from comes question you. our Schott Thank from Chris JPMorgan.

Your line open. is now

Chris Schott

Great. questions I appreciate the here.

TEPEZZA, a on from couple me a UPLIZNA. on and just Just follow-up

Like on be. question second is just between gating, thinking us things. just patient color kind bit of about balance we And the you run of of get sense forms to an weighted you relaunch. just with all-time trying where we’re versus high get start much forms then final UPLIZNA just was as will you seeing the my think the Sort how like of you’re stand in in then And a how a now these more around per of month seen enrollment XQ, XQ? the little on quantify April. uptick last many the XQ, these you give mentioned, I’m of you’ve new can seeing XQ hands overall. of rate quarterly year? side the where how results the you terms sales in On how patient terms we just had of Can of of

just NMOSD, Just putting Thanks. cetera. you’re the as in et thinking any how product product resources we sales force, the behind about latest about for about thinking think peak you’re sorry, the sales in

Tim Walbert

Sure. Thanks, Chris.

billion thoughts $X are as as UPLIZNA opportunity. we it a molecule, see Our around

the into opportunity that in significant more total that we’re we we PEFs, confident. of a down NMOSD than number achieved more uptake working talked numbers year through PEFs level broken were is haven’t we we getting and months achieve had drive indication, Relative confident, other to The basis that to on We the about by feel launch. to one into even of not continue we specific the never had that objective. dig that in of but saw impact the monthly last of – COVID, we the few as things first and of

about level fact And really to that significant a be talks of from in and and new also record about we some patients able perspective. opening see have COVID PEFs high in a demand the April so to

gives that us definitely drive place to that a So confidence achieve our objectives. we’re continue in uptake and great to

Tina Ventura

next question, Justin, please. Chris, Thanks,

Operator

you. Thank

from question comes Annabel Stifel. Samimy next from Our

Your line is now open.

Annabel Samimy

for Thanks question. Hi. taking my

one where many to one don’t You I know UPLIZNA. have on start. even now. on programs I’ll so and ask TEPEZZA

you those So think of the inhibitors? starting TEPEZZA, development guess of been program. are in? success XX% seeing, the there’s does with chronic guess you of on complement who in you’re you data test use others UPLIZNA, patients. increasing a FcRn that given limited and How And where new to you’re use depletion and new for are on not patients then stopped had and in I I in do about would TEPEZZA development patients, terms or gravis patient label on the program Of in cells chronic more are And sit light the curious see restarted, and chronic myasthenia the call the patients B-cell about use? B Thanks. what deep I’m

Tim Walbert

let Sure. second. take I’ll first the take Liz the and

So population digit weeks in. And high-single we issue, percent as patients. overall supply obviously, we’re treated the saw relative two of the a before to temporary chronic

don’t treated we far So as breakout. have that patients, as

in first far get but the PEFs the the we changes anything see been and quarter, quarter, we time. But we’ll didn’t I our in as There’s year. there. fourth see mean, this fourth that generated as we have have to see and process of don’t As over how publications in significantly we months understand and a more this, anything, that perfect changes weeks lot to over data thought we see didn’t

certainly as improving and reimbursement. gets So more data help to the speed raise awareness out, also that’ll

relaunch that’s in early think really I tracking comment phase. how on So the Liz? too to it’s

Liz Thompson

Yes.

the question gravis on myasthenia FcRn. to the of turning So and UPLIZNA, context in and the specifically

in depleter one different going FcRn historically and going producing out. an out gravis in taking FcRn B-cell been in a depletion the that the frequent much we’re going MuSK a be them There’s seen autoantibodies clear sort doing robustly aren’t be of to has and up. as to are is from approach with is program. it. what FcRns the example. be an state also B-cell suggestion So myasthenia dosing. is how very the implications at some already required be, to more In are that has looking that for is case, our as going maybe to this what you’re This population, disease you’re that helpful other There That’s cells having the systematically to to showing

the see course, to real out our what’s reads for So overall day. differentiation. of going how is end some we matter trial at potential Clearly, actually of the

Tina Ventura

Annabel, question, next Thanks, please. Justin,

Operator

Bank our from And Jason you. America. of question comes from Thank Gerberry next

now Your line is open.

Jason Gerberry

Hey, for guys. Thanks my question. taking

referrals indicated the indicating was of versus the they like that we scripts. different, physicians, surveyed you impact market are guys question, some beyond going with but and up a a sort levels, them have starts, adopters, goes that early with of the year about where like just trying and of that seems market two they this prescribing TEPEZZA the broader and these peak So kind where their they’re for the ultimately when one think noise of marketing lot to of the and patients, aren’t or Just your only prescribing like new of XX% disrupted it efforts? this looking are

them? DTC campaign trying the leg hitting about, the to other just prescriber out Is efforts, about more growth the that what of think really was of So get drives talked to it next of sort story? TEPEZZA driving leg cohort? to it kind the referrals in Thanks. that understand activating of next of to more early growth Just prescribers what drives of of adopter sort Is trying the base overall? that XX%

Tim Walbert

all One it. Thanks, of Jason. without another. doesn’t work Well,

campaign the You can’t right DTC strong a without through. pull have

increase of our significant drive commercial I it in with uptake. DTC, concert level So with organization work continued in concert should all in at a increased and to an expanded think

saw as the specialist. a national it month seeing a requesting of a increase first to we result people the our DTC we’re TED with So last being significant in December find year,

So a there sign in stopped first We national the then with great the ramp our up of quarter. campaigns.

up on branded that and the also Monday So DTC. kicked TEPEZZA again,

both be success. of great Thyroid XX% Disease. patients long-term So driving to efforts get going Eye and to are all of these short- ultimately critical

being through consequence getting knowing understanding able a one, will to that TEPEZZA. that accelerate, Eye to getting So accelerate Eye a potential them potentially options Thyroid ultimately to they’re Thyroid for Disease it of Graves’, Disease and And is there’s consequence. to treated treat

getting be I these So Disease patients effort to Thyroid to leveraging of success. active from with all and our commercial accelerated increased getting are short- our all think patients, driving ultimately in Eye treated, Graves’ long-term critical going and

Tina Ventura

Thanks, Jason.

Justin, next question, please.

Operator

you. from our comes from question next Morgan Thank And Risinger David Stanley.

now Your line open. is

Melina Santoro

This is Dave Melina Santoro Risinger. for on

a inactive TEPEZZA have trial. about questions We few

below proptosis third, know than score three? patients an small enrollment represent frame such statistical activity success So inactive less the But in is to inactive severe end the first, the what how it in real And clinical and because the in technically patients with XX? greater could than moderate year? number given with criteria any population? a you I one. it’s of world percent does of please confident are you treatment Second, is

Tim Walbert

Sure.

take last. the I’ll So

have years, part On the or where speak she’d trial between if average, eight three they’re inactive years, disease. XX,XXX because and patients Liz As population. really they’re that’s first to we that like. said represents eight about for years the less, patients can two and first who this

Liz Thompson

absolutely. Yes,

this benefit. carefully looked would well, as that sample patients at be necessary based sure into study making very population patient be adequately this moderate with So patient to of how It these size, And population, and part a to symptom of of millimeter the as this you have X did able is the can primary well that we’ll effect looking with significant and TEPEZZA the you levels enough population. our simply sure would on patient to is consistent imagine, we to of that’s conservative see of design to overall look as at response to thought here severe of When we as see a more about to this a some what assumptions be in variability make powered that just about want we insight change. particular carefully proptosis, of give that proptosis. basis in think on have we endpoint the do appropriate

we feel of overall, in the So our study. confident design

Tina Ventura

Thank you.

please. Justin, next question,

Operator

and from comes Thank you. Ken Cowen question And from next Cacciatore our Company.

Your open. now line is

Ken Cacciatore

to bring to the want just back some Tim, much. of TEPEZZA. so Thanks around you metrics

patients, the envelope, none perfect, of this of the and is enrollment seems of if some maybe going and the doing more as in Just least would it you have through back know process. I at X,XXX

issue, us the level. treatment So about you understand for seem if – you’re and rough if know for commentary you at the any on starting be or it cleanly before go patients guidance we logistical to guidance, do kind see I many a through of math around system would Is patients number more the can of a but And help that? may you’re it around want already some on full guidance Thank talking get just you of readdress continuing this these you how of year? maybe through us patients, to give you. we as accumulation with more can kind

Tim Walbert

Sure.

August. quarter report going will guidance numbers. that as came really patients. tracking execute gotten sure we’ll to their continue have two not infusion weeks year expect weeks either scheduled or the we’ve with Half and early physicians And consistent not second already and we’re we’re in on so seen We’ll change the we from things. So know of more a complete data. the them in far here far great we and and certainly to where where from based not X,XXX for two as out response as of that’s our But so lot

Tina Ventura

Thanks Ken. Go ahead.

Ken Cacciatore

to? the European to I’m that or progress authorities and focus regions with regulatory any other ask just kind on going you’ve of should follow-up on we just been maybe pointing

Tim Walbert

see said, we East that right $XXX where and and now opportunity TEPEZZA. opportunity. other on Middle we’ve million America, than markets we for And So, focus yes, Latin as see Asia, so greater is Japan, is our

PDMA in in making We’re constant Japan, there. the with dialogue progress

attain a be So the move opportunity next to orphan continue drug expect to look the would to designation Europe step. avenues what’s significant Within we that for outside we continue to U.S. to required

designation able orphan to we be won’t drug forward we’re obtain Europe. moving until in So

Tina Ventura

Ken. Thanks

Justin, question please. next

Operator

next comes Thank question Tewari our you. And Wolfe. from from Akash

now line Your is open.

Akash Tewari

Thanks a lot.

a TEPEZZA remaining TEPEZZA. patients method-of-use have of for pass of who So during running patent the getting pause a to kind certain on getting on proptosis lastly, off, abandonment? and of supply your with the patients are trial broad-term patients, you just seen many noticed Orange types takes could do patented from that to go other separate the disruption prescription considered And we infusions of the book kind that about the recently of some label how down Starting durability XX, the with have talk few Thanks. any more say and we’ve language seeing TEPEZZA. on patients you given of on rates eight puts then a doses study, average although looking you plateaus end around points X the continue week kind your Phase response TEPEZZA, label help dosing cycles line? And let’s and chronic then of on redosing have longer treatment filed for the you effect? out, Can your redosing about either through data OPTICX on versus redosing

Tim Walbert

Sure.

average on So patient about their dosing about that the on – was it average was disrupted, through average. halfway

if look about be there’ll you So that, at four.

metrics. we you quality of different to of number patients to We the improvement number are a trial period, life continued through XX-week the of a it – the that across seeing look other XX-week metrics from in in if period saw

time. doses trial, retreatment, we in did patients, we So the is in at are eight to that to not retreatment OPTICX dosing required of months shows or benefit this these data point Relative six longer at our pursuing full look a population to Thyroid the in showed covered don’t treatment the are of that add it is not included and Disease. that standpoint that is as And the from Eye we to current our plans patients forecasts. have label effectiveness that currently in patients for

current individual that be reimbursement in So covered becomes discussion with that plans. would our we label believe a and

we’ve treatment so for had seen again, we haven’t give evidence would – any retreated months, that us point. that haven’t any patients of number We really three to haven’t

what there a see time. we’ll of is or if over looks we guess patients, this at like, time, regulatory retreatment see in there development strategy but some that don’t I So point

Tina Ventura

Akash. Thanks Thanks.

Next question Justin.

Tim Walbert

the answer on – patent. following Just the the question to

patents opportunities clinical have on We trial filed broader results. indications and on based our

pretty practice. standard that’s So

Tina Ventura

question? next Justin

Operator

Nachman And BMO from from you. Capital Thank next Gary our question comes Markets.

Your line is now open.

Gary Nachman

all And Hi you you else the the like would besides in-licensing backlog. for be Is supply manufacturing in Catalent? your guys. sure about what Good you’ll UPLIZNA, slot products at Or more demand get need another just and morning. in you. going you’re sounds that meet you to What funnel that then could It second talk again supply issues to the from at there Europe Thank just I TEPEZZA enough one you Europe slot to before building just Catalent from have get be there? from that place? potentially? want that won’t forward. infrastructure portfolio make manufacturer

Tim Walbert

rare what with Europe, we’re consistent In infrastructure other companies do to typically. going disease have a Sure. Pan-European

supply, build. it’s made. on one will said long-term we Relative licensing or lot infrastructure so U.S., look period limited our medicine. month at run be activities disease does rare at a the a where we’ve to as that what development business with and medicines ongoing average, into global launch certainly to So we other supply look a would feed each able about And not infrastructure is we TEPEZZA Europe to can that’s

manufacture TEPEZZA last the to uptake able we manufacturing we’ve year with Catalent and continued continue satisfy manufacture will be and for to continued to manage expect beyond – and and expected since TEPEZZA. that We

by our the make getting to made also have online We – the progress second manufacturer year. of end

this time. in are point confident at we ability So in to supply our market the

Tim Walbert

Thanks Gary.

question Next please. Justin

Operator

Jefferies. comes our Thank question you. from from Steinberg David And next

Your line open. is now

David Steinberg

morning. questions. three Thanks I and good have

out than curious launches, time [indiscernible] there the any over more of was higher with initially and now historically patient that number is – has is for a patient just some first market and so are the your is I drug the The are for orphan And launch, year have where market that on or there’s things. out changes three not look there patient the into in a I time literature on of the other that learnings awareness months there number you thoughts patients of works. the patients found patients now sales effects the behind of that And a And been on when often had were I was second drug lot and thoughts patient question doctors obviously going development, the that Have drug eligible a at more then the and lot know you pool? on. then to just re-looked you there experience could thought. there on a – peak make assumptions therapy you four you of but treatment patient were a curious, any learnings your any of is lot on have effects pool? dosing? side the better wasn’t optimizing on to subject, business when side

– to payments use some understand XX things as looking took launch denied of but most through, the percent programs. patients therapy. then for question curious – And sorts said reimbursement, that development of And of who a including for? did what the there I your you are was what stakeholders gone is it are on an BD? the who I just end? Is further on the you appetite been of have the surprising think have were payers, I lot of final there Thanks. rejections, most Roughly not compassionate

Tim Walbert

Sure. level. have if point anyone I’ll on exactly, nominal the end. know really use. don’t sure but not we I’m At this at a start we have I compassionate

hurdle there at to not overall generally it’s any and and side. to medicine a into a has expect the significant rare question the continue patients This those moving work bit around disease year patients with better the we’ve all that. a side we what changed. than of we seen the There’s Adverse has in nothing a in-line to point little events chronic new reimbursement relaunching, more therapy use more effects, dosing this see may label. been over we that’s are not program consistent and been with do similar on on a safety just time make through and is the as our updates continue takes events, data sure adverse clinical we Reimbursement effectively. discussion, in We’re process it are level But see plans. expected material as more in don’t our And provide a change last of think few, we but evidence discussed time. our to but been be compassionate that the and treatment we to I we studies other collect

time As the We as our guidance and the peak XX,XXX far population chronic sales as about same. patients to the in remains population, discussed. see patient we’ve

accurate. those that into in Disease and support XX,XXX numbers Thyroid continue with to XX,XXX feel continue to the strong are patients market the Eye We new see to confident acute incident coming we

I around change we it’s expand we and but there’s patients think our education that. see over Graves’ to discussed programs a more, time, if look We as of too impact disease. DTC in learn early of I’ve the the to accelerate eye as significant may

line to we continue be to be on and Lastly aggressive to transactions we development, add stage pursue aggressively expect therapeutic potential our in business medicines. other there with development further areas

Tina Ventura

top question. the at for Looks like we of hour. we’re have Justin, time And David. the Thanks one Great. more

Operator

And our question last you. from Guggenheim. Thank from Dana Flanders comes

now line open. is Your

Dana Flanders

just in, questions. I quick two me squeezing for Thanks Great. have

chronic sense chronic longer kind at Just the Wondering any all first and TEPEZZA the the have efficacy wanes on if study. had the has you of if disease. patient of TEPEZZA

if us the on on vials the for of then currently. with And that you update my give patient efficacy KRYSTEXXA, given immunomodulation kind quick stand where So all uptake kind in use, design? for you’ve you would average one wondering instead and study and net patients per a had consideration and of the you expect at second success with could just disease of eight better an just three-years was Thanks.

Tim Walbert

Dana. Sure

right eight vials with patient to seven now KRYSTEXXA. per about average that’s on So

over We at the immunomodulation percentage KRYSTEXXA the We have XX% as plus look last of to the XX% patients XX population are about and increase year seen patients in looking years to and good plus chronic seen at to that now. have three has eight, increased treated versus very TEPEZZA. with years patients past success out diagnosis being past who we’ve diagnosis taking

phase. not spectrum broad three differences feedback acute the of that from physicians, to any to past hearing we’re years seeing relative in and So XX time

Tina Ventura

will for Great. Thanks, approximately joining concludes replay hours. morning. This Dana. be thank webcast two Justin. and And of call us. this Thanks available A this you, call our in

Operator

you concludes conference This you Thank today’s and may disconnect. participating Thank call. you. now for

Horizon Therapeutics Public (HZNP) 5 May 212021 Q1 Earnings call transcript