IMVT - Earnings call transcript Q4 2022

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Operator

Good morning. My name is Melissa and I will serve as your conference call operator. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation [Operator Instructions].

As a reminder, this call is being recorded.

call be the on me today Dr. will Joining of Salzmann, Chief Officer Executive Pete Immunovant.

results forward-looking statements to risks assumptions and successfully marketed, commercialized. Immunovant differ forward-looking are subject based a potential expectations reasonable, of of I data from XXXX, All remind to statements statements the develop batoclimab clinical plan trials, the to range in the the approved in readout autoimmune of June like XXXX; actual half readout and broad conference we X the expected include, Phase including topline Act plans would materially calendar timing, MG Immunovant be an in expects. Immunovant’s Before the of the begin, indications, year are X regarding on product to uncertainties the forward-looking indications; its the These to plan of Immunovant’s with readouts; Private estimates Litigation additional whether be include in by year statements distributed, may and TED and Phase to in forward-looking of timing and management design year two to XXXX. half the and batoclimab with other its call certain second Immunovant’s are announcement calendar and second a batoclimab of All clinical data half everyone first Immunovant’s will statements results if trials trial an calendar of within clinical those safety things, by and for believes candidate; XXXX meaning among Securities end Reform although regarding that inherently across expected that cause future will uncertain. efficacy of of today’s that XXXX, initiate of initiate Immunovant’s that

June it forward-looking statement update to and the XXXX, speaks whether X, only year undertakes Immunovant as events, with the or annual Form which obligation ended review information, as on publicly forward-looking a For new are report SEC. of no SEC date otherwise. filed any subsequent or with Any Immunovant’s more Immunovant’s statement, revise was filings on XX, made, March on result information, the of encouraged future the XXXX, investors and XXK for to

Now I call would over Dr. please the ahead. you. like Salzmann. Dr. to to Thank turn go Pete Salzmann,

Pete Salzmann

big alignment eye And half Melissa. call This to second you to for of today. share for to placebo thyroid Immunovant, a Ophthalmology disease TED for now Division to FDA XXXX. a thanks plan the forward excited move of Thank achieved I’m and TED. pivotal X joining with everyone or that milestone is Immunovant controlled very the the recently we program in two in Phase trials initiate with

in TED these batoclimab, with a and the data program trials to the exciting have pivotal market We we program for is represents half an first opportunity. class topline XXXX. of expect second have first announced for in

this has from heard March, paradigm shift TED. the treatment been R&D discussed we in a we past day our physicians, As as there of at and

gain are need patients high teprotumumab the innovation, treatment approved access for some XXXX, and now FDA FDA rapidly physician historical thyroid already lack only a in then a can the unmet of the to a option with the which of who care know, medication. you approved disease under new approved January When of disease. many As are medications eye of new for is

market physician care expands. of types the be a under these addition, of and or among not of patients, growing disease awareness In decision patient may awareness making The impacts the specialist. approvals also who other physician yet raise the

to TED of I batoclimab. design I’ll fundamental how batoclimab why gland. clinical some thyroid case related continues to and thyroid time, the thyroid and big features. expand. eye market anti also disease. the the Today in action. work labels a believe the for for market bind the receptor the and disease unique the thyroid antibodies while, of for dosing, thyroid and to points top in the we start mechanisms TSH hyperthyroidism We binding the drivers believe autoantibody opportunity will in the we disease growth and is focus market duration TED of At net that after has follicle, supports differentiation TSH to figure, lends continues the eye by specified metabolism The itself some seen complementary immunology in our markets to reviewing Fixed similar TED, the to In of first disease. are for antibodies receptor same the FDA as Graves of In opportunity very this The other have X will to may Phase receptor the rightmost be This an itself the auto of the for and result increasing therefore experienced steady is release TED. hormones. We of grow, awareness innovation. the for The in the figure, in cellular of quite heterogeneous row body development action. believe and in of the new unfold mechanisms patients a complementary of auto is batoclimab TED key this exciting TSH on circulate and what introduce important activates of receptor. the be biology TSH

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receptor in the the between be receptor disease. crucial of the the IGF-X appears crosstalk to and TSH this pathophysiology So

mediated batoclimab recycling observed most circulating takes binding As IgG of anti-TSHR FT inhibiting on regarding to patients endothelial by the prior you antibodies reduces study. in likely presentation from place cells. and normally in review batoclimab’s that in a receptor of IgG TED some impact I’ll later know, the data FcRn

Although proptosis, but This that proptosis different is than eye symptom TED. includes a the in of disease actually feature Indeed patients conjunctival bottom in variety The eye condition. patient. example to a photos eyelid with thyroid of them. the provide can pictures TED top is of panel. in heterogeneous degree vary prominent patient changes important experience two of edema TED has disease, the patient the these thyroid a together symptoms. how an differs people in and is redness This panel heterogeneity more patient between Both have of common inflammatory much people and slide

market ongoing on old, making modifications also working our the to a lifestyle were TED despite active which range We research, The XX% moderate with we making therapy lifestyle years reported prime reflecting systemic between report age treatment, even modifications. they substantial or that, consistent responding. found XX TED with patients Based patients were population. of participants and with surveyed XX major

electronic participants was patient across the fact, varied, as we working goal there on rank goal, in devices, was important not difficulty top their participants challenging, as shared engaging When population. important to challenges particularly the a In single most difficulty treatment social patient. patient life Rather, most situations. and highlighted the impact goal reported to treatment asked driving, on work

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improved the innovation that long was approach wait compared post-launch and is hasn’t a common This I applied. treat, historic development diagnosis and any my to watch in rates sort urgency time. frequently in opening to in of made probably the TED, meaningful its The As since on impact mentioned comments, a in TED treatment reframed teprotumumab has launch XXXX. certainly for a has disease the early has launch market had of that

the continue, to specified the but we In dosing this duration has unique market which label. centered immunology common favorable TED also to market FDA in around of is ophthalmology. in fixed some in of Fixed the duration addition uncommon dosing growth, expect features

of in In the for specify duration TED trial. dosing period dosing may to insufficient will a the clinical duration FDA fact be continue because the label controlled by important many we that the the believe labels This defined specified length of for patients. is

disease action. frequency is becomes in week simple reimbursement Such additional off-treatment and We noted more XX also XX-week period, in but least were of is treatment. XX, because course the a longer, a often only opportunity suited be an for heterogeneous responders will mechanisms not so opportunity Tepezza in believe in likely XX% action, at is at limited route proptosis complementary one to who patients the complementary OPTIC were mechanism important, administration for medications. ideally for label, FDA of new week not subcutaneous at specified to because As amenable is OPTIC responders follow-up the treatment, strictly of of the and of this even here series, of duration TED proptosis a that highlighting

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we this to really market that beginning a So full very see potential. its show as exciting just is

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our one exploratory XXX XX This with was includes final several of study. the highest delivered proptosis data leading study So an from XXX week level This over period, subcutaneously. a XX data seroconversion milligrams points observed slide the design, of shows same initial to of in was milligram arm. the dosing weeks that

our As trial. a on reminder, is TED week slide Phase Xb this from of the six data

data centers, Although trial time the week we point this at response primary numerically was patient the after latest an also analysis graph endpoint higher dosages. XX this a This post-hoc scan shows prior for of weekly selected shows for CT proptosis this CT central had that by all X, find data week XX, of stopped week CT weeks Again, dosing X few voluntary significant scans was slide with represents data prematurely dosing. because had were to largest the done specialized in who at pause. not baseline a I for intriguing. available of subjects completing terminated amount the all treatment who a subcutaneous the and was being At CT point This rate end treatment early scan higher reader. were by time observed very due injection. at the interpreted to it and

can in extraocular total As muscle axes, volume. Y on from percent show see change the the baseline bars you

suggestion this batoclimab Looking group. muscle smaller on at week a observed groups, observe observed scan increased milligram data on effect batoclimab muscle of We slightly the with while CT in a decreases dose total slide, dependent XXX subjects other a of volume, in volume XX placebo we numerically average. reduction XX% on

of by that our in blinded same for the encouraging the our TED believe in a development central Of and number in patients. a these time, done disease. from thyroid trials reader, are complete course set Overall, from pivotal data exploratory is trial. CT were we the program eye the readings this batoclimab are At endpoints very small prior data

has trial XXX development, class. that that FcRn class. may with anti of typical shown other beyond differentiation batoclimab Whereas milligram believe dose weekly the and This XX first milligram around our initial period of IgG leads design. XX% required XXX these provides initially, data suggest our suppression adds also reduction something to dosing, unique IgG higher anti-FcRns that even We lowering dosing weekly with levels consistently subcutaneous dose XXX IgG be week milligrams to in within our

medications As two identical in the the in has that we’ve trials FDA designed two provided for ophthalmology TED, to division of studies pivotal guidance required run parallel. are new

fallow in to responders as without weeks. next baseline primary where eye. inclusion measured pivotal in the from study trial and one batoclimab or randomized reduction arm for efficacy The programs to approximately eye batoclimab with TED, to XXX versus batoclimab other weeks, randomization will a the receive XX enroll by for to criteria the XXX weekly to XX the week expect are We proptosis in week of ≥X will either milligrams deterioration delivered as subjects millimeter for similar period. of XX XX key at be placebo each for the two treatment milligrams delivered first batoclimab Subjects to weekly XXX followed defined are proptosis endpoint in responders placebo, the a

of As of in XXXX. We and have previously, takes namely subcutaneous batoclimab’s design I data first route TED trials the trials plan XXXX, Phase from X half advantage initiate IgG of mentioned calendar these attributes specific reduction deep and in both the to this half the topline in to expect administration. second of year simple

and our with Finally, trial batoclimab. this Phase and pivotal later here’s first program of XXXX. FDA X a in the to in for with month, reminder the review anemia. our X of of as our second MG We for to development MG engage hemolytic on this batoclimab, the plan warm autoimmune division Building our gravis represents a with TED, we expected overall progress hematology trial plan discuss to development program half year topline Phase initiate myasthenia data calendar

indications new August We also expect of XXXX. committed to two by previously announce as

your trials the to Beyond team for that general TED, the indication initiate like questions. expected plan with much and MG XXXX. three our reflects the open it time, development anti-FcRn pivotal planning XXXX, a initiated in for more This you enthusiasm to space we’re up Thank total for and trial particular. so in for and in has to calendar I’d in bringing be to batoclimab one pivotal year in

Operator

you. with from Instructions] session. first comes Thank question-and-answer a Robyn time conducting proceed [Operator Truist Our Securities. this your At Karnauskas with the of be question we’ll line Please question.

Robyn Karnauskas

Great. Thank you for taking question. my

you will as patients primary use moderate therapy, sort about, was can Tepezza, beginning around second would talk XX% or and similar what that around do patients, has that of follow any done which it’ll bit and six around your a thoughts think line research the to but product label? question First, anything first you profile give choose expect that a in the one the up Thanks. about, little the for you you a [indiscernible] other seeing see make the over I mentioned endpoint, a a there, I and the assume research, you that you market the that think doctor a in patient there’s market you think do around why could you Do flexibility a Then be for for FDA that? months. like what that? similar say you’re is, I

Pete Salzmann

it. questions, I those appreciate for Robyn, Thanks,

XX% more spectrum the therapy severe, go terms thyroid detail groups. more reported all that and So were research, or reported they market in the were to in was between it steroids with of with eye patients in active with so into They of improvement a Tepezza in them consider systemic but after regards mentioned recently market moderate reported, across just making moderate even conducted they was modifications, still research disease them, actually the XXX% on It the to a either as product the an them spite to from research of or we market those with where and of there their Then section improvements the about launch was had Tepezza, the moderate I was relatively asked first U.S.. conducted, there, symptoms, medication research of we even of lifestyle question therapy. both split in little for to market than of bit it profiles.

label. the was FDA to Tepezza approved for the product So just equivalent profile

lack than of When bit different and profile. product those For as mentioned, so subcutaneous chose was route a people batoclimab, chose that and assumption Tepezza the the comparing some profile what an proptosis less actually product things, efficacy spectrum any a included in profile. that two hearing I administration, little different loss people of across Tepezza the the profiles,

is has that the that’s in Some of on of batoclimab spite probably towards of someone consistent there the who when profile. they’re But the has people Tepezza efficacy very, to the impacted, spectrum the profile. the very more where, of lead think going people adverse choice, severely treatments any outstanding first just moderate demonstrated And a chose a lot were -- then conditions very that to I side with being events. tended batoclimab

the for impacted, is with sure, irreversible more less bit but moderate, and profile efficacy drawn but that who issues potentially little a issues. other to for provides On safety safety someone hand, no a more they’re

standard that that a therapy a was strongly in big to course approach route with that are TED, likely people role, of The split the six the fact suggest that only months. I To our were was were therapy with a of came these that a to labeling. aware interactions point, who that approach of have being systemic spite ophthalmology were standard So subcutaneous treated the of with say, total programs of really duration how division regard in pretty also have very to have development and and they administration to out. the to played label,

disease reflected placebo the XX similar be I a controlled the key think tenets Tepezza eye So a other program, in that’s week of program. any product label meaning for has will thyroid approved that

Robyn Karnauskas

data, also up, have given I enrolment? was the like that is trial, a to ask have period? as follow there’s the assumption going what slower, for just Tepezza? awareness timeframe around just for there that And patients you disease. allowed been the shorter it, you given be washout Will do guidance Got of on for the think a and previously you’ll to Seems your XXXX be more

Pete Salzmann

Right.

run timing Tepezza the the trials, sort of experience So between our in terms trials halfway would the is these second actual for parallel, the of two in first the trial of trial, enrolment assumptions for and which for be their trial. two

obviously was faster. first and up was They The and second sites trial had positive. the trial running,

for So I those to second compared one. things, accelerator first think, trial an two the the were

We in the bit be a no position There’s Tepezza do least more of when little Tepezza market. we competition have we will sort enroll the the Tepezza? which approval the took question, in program. we true for there’s is previously you there with spite a will and first additional of question product, U.S. at of always that which So to only for patients was, a expect in include awareness, approved generated bit patients an being middle. treated down U.S., were -- the pivotal little not, has But to the who on now That leads the will

the Tepezza comparison, had to pivotal close patient as program population, apples in with an to goal apples the theirs. with to have to regard is as Our

to naïve Phase biologic trial a could or something an Phase be for having any like but in future be it therapy. patients rationale patients the who trial. for that’s So opportunity are our That trial naïve X that, pivotal the will X for

Robyn Karnauskas

you. Thank great. Okay

Pete Salzmann

Yeah, you’re welcome.

Operator

Thank you.

next Please comes Our the from question. with Wells Derek your line Fargo. Archila with question of proceed

Derek Archila

and good for and the Hey, the for thanks questions morning update. taking thanks

in failure top there. on Thanks. second assume in the XXXX, guidance that does about the just wAIHA I enter from of out how thoughts, Then from question, through to couple track TED recent thinking kind I the kind that mean, to though. different get forward might on line your thinking us, a just cash cash moving and and that wanted you with fostamatinib about wAIHA Pete, the your of opportunity Just data? batoclimab have

Pete Salzmann

That’s I’ll one Great Yes. easy answer. answer, questions, answer the easy direct second and first. the Derek.

that about clinical would have a know, if limitation but totally in not big be similarity there. can their feedback just in placebo clinical That’s non-steroid Non-steroid might applies rate to the is I chance a the have these saw, by kicking long time very a is is gotten we’ve interesting, big to a used. happening, trial. guess, morning. was fostamatinib geography, relatively investigators longer duration, lot I’m whereas are midway the clinically. sure of sure one in trial, trial, through any you has had one. you geography area I think, The the of you issues which potential by be? something across Why response think have X is work. allowed, immunosuppressant immunosuppressant there which been but it response a was question is in non-steroid someone everywhere for in that in trial nuanced limitations also information a similar. first trials where of Phase the might ones the least them of I a immunosuppressants, and And where arm I’m there’s this a release, there at It’s variation amount as in this use allowed immunology which did press call’s protocol to published, was rate parallel cause that fair take placebo the the one they to guess I big an as therapy, particularly our a in I where trials, therapy actually from X that medications review the whose Phase for This

placebo So telling expect much higher in it’s of would again, possible that seems true some what or arm. a saw might in than it. those explain one are that rate in response The hematologists that placebo Eastern they us, geographies, Europe

you compounding then if medications and there. the causing in concomitant wonder So kicking are a

Derek Archila

guess, about competitor indications? I that there, versus thoughts your into wAIHA not does the undisclosed how of is into that maybe and like going kind now factor Okay, that

Pete Salzmann

is Yes, done sure yes, the point design to is first I mean was think make the making. I I trial Well, that thing carefully just to the really yes.

mostly just more which opportunity, is than solution terms not In with even morning, really moderate oral markets, side Even excited wAIHA. wAIHA, without that because occasional prednisone of term effects, of so had actually this fostamatinib, I is if may been we’re lack blood are of an within or targeted there’s the really mean transfusions, therapies GI just in this doses results innovation with steroids therapy least with it are a chronic unless major for The at but non-steroids, very about I fostamatinib reported long a use. be a the therapy. think, satisfactory positive limiting used

lot. sure I’m So, not -- it is this a changes

what Our which exciting could thinking in wAIHA. is centered around do, batoclimab can we believe be pretty

Derek Archila

Got it. questions. the Thanks for

Pete Salzmann

Yeah.

Operator

you. Thank

Our with the question line question. from comes Securities. next proceed your Please Thomas Smith with of SVB

Thomas Smith

Thanks taking morning. Good guys. Hey questions. the for

alignment guys were into Just TED? I plans the did a dialogue you settle lipid management a couple on discussions the Like And FDA? there visibility guess, more program need bit you the achieving for with in and regulatory on TED, here can some of give in us around where a any that? little

Pete Salzmann

thanks for asking. Tom, Great question,

people previously than trial safety greater same We we XXX criteria for monitoring baseline have the will apply the TED have who than discussed an existing have greater the cardiovascular for XXX. LDL LDL exclusion program MG, to have narrow who clinical and disease as same or identical and a

prevalence and population, patient a on fine, be that myasthenia statin, the in just with the would statin, on a the trial, of that come a that’s patients broad not hyperlipidemia controlled that’s who expect on As and some have into the problem. based trial we should there’ll a

be However, excursion. LDL unblinding the due any during statin there any to be initiated clinical won’t use trial, and won’t there

similar was our and neuro MG for discussion straightforward program. with division So the to one the the

Thomas Smith

in to on there inclusion/exclusion severe patient maybe more the spectrum? makes severity with more That on it. you’ve got patient end severe Okay, the up moderate anything of that targeted the a the disease the population spectrum. Robyn’s Phase X patients moderate enrolment, highlighted criteria specific less studies moderate maybe maybe the in for role drive these of question enrolment potential sense. Then, following on Is could greater on disease,

Pete Salzmann

No.

there’s common, which In probably like the in X, something clinical versus floor the of it’s that. that to opposite, activity fact, or little score a a dropping it is sense bit a X a

to the in clinical moderate is expect to really of the people spectrum. population. a clinical moderate fine. who That’s more generally What we severe just decision It’s making. that same. discussing I totally So the have severe. the to little severe efficacy population more kind I to group more trials are really severe good bit was related Often mean enrolled just on are in

TED use to a different physicians If that’s going be approved. so it’s large for you would have moderate think profile actually of a they clinically, a first, other. to will a patients pick have pool, and profile I they batoclimab’s Tepezza straightforward the each have of batoclimab sort and patient, works for just you a generally them to spectrum make decision, to for two of sub The they physician relatively and That’s severe one kind assuming product, profile, of they that first, of of natural. different heterogeneous would a prefer decide where a that products, sub patients, use where

in you made, series. our a getting clinicians I the in complementary which how which there. both, end individual the of those first, be probably terms is think the therapy what is will their in patients And do meant question of outlined and decisions up vary but day, will decisions given then one end will by in many I I thinking get

Thomas Smith

that be it, other makes on there Then just lastly a in out are programs TED. there enrolment, enrolling that sense. few also maybe could later studies stage Got Okay.

but the Western you regional and from and expect get have Just between Canada as a do Pete, about know versus regional you of you geographical think kind of this Eastern Europe kind for some I patients that sense breakdown the at you mentioned, U.S., U.S. the to enrolment, Europe versus point?

Pete Salzmann

lot have of in that, rare yet, as don’t I expansive important. the and to trial, there’s clinical to be into we’re across but trials, was trials be all projections all opportunity by an that detailed to we pivotal that And potential have patients, do given our to Xb good tap our site, looking of diseases. a trial possible regions pool competing previous anywhere that as country expect we ensure of true in a

at just something So that’s definitely we’re generally. looking

Thomas Smith

Okay. sense. questions. the taking right Got appreciate thanks Pete, it, All makes you

Pete Salzmann

thank Tom. Yeah, you

Operator

you. Thank

of next with question with line question. Douglas Please the H.C. from Wainwright. Tsao Our your comes proceed

Douglas Tsao

questions. taking the Thanks morning. good Hi, for

maybe, you tolerability suggests just of of sort from that more that for batoclimab Just of curious key some you line that did mentioned in terms patients in its there that attribute get I’m I as think tracking. sort a that therapy. are moderate terms of work as first Pete, -- traction might

were that tolerability. just in terms came of the particular issues Any to I’m tolerability out research? anything Is So particular market appealing curious in what the there that relative physicians?

Pete Salzmann

Right.

So Doug, appreciate that’s a great question, I asking it. you

eye any something decision leads whole draws profiles specifically been a negative state, and is unblinding, we their of the setting, with So, required, patients for Outside batoclimab of of that euthyroid the part the Outside tolerated. trial, -- they’re of these types be the in blood monitoring, part that to in [ph], trial to the but them getting product used preference LDL them disease, and or so be making could levels. even [indiscernible] testing for choose with were patients being has profile, maintain treated perception because that, didn’t monitor, of which to which that many highlight, some the both may case. in changes anyway not be are the to function draws there clinical physicians have monitoring generally potential they’re to led That we many that the in be of physicians with that though on as on patients. did anti-FcRn of the to in well done batoclimab thyroid there’s seem thyroid in may regularly regard to blood could the the blood class

So option. some for reported have when been a they the have another Tepezza, trade-off, of some are people that particularly events adverse for consistently

So research. decision that was kind the went of making how that in market

Douglas Tsao

Phase MG and you expansion you just, do in the needing additional you’ll safety have completed; data X of anticipate to sort great, file potentially then Okay TED? do anticipate

Pete Salzmann

every safety requirements generally exposures. -- division unique these but all similar slightly so Yeah, has for

to pooled. So is exposures good FDA, the with we work be understand across that, them. can consistently The safety each news division

our BLA, those MG have TED and that the being for for patients So in example indications, safety different patients in of be vice studied we’ll TED versa. submitted exposures can -- outside in having program

meeting in requirements. helpful, that’s of terms the safety database So

Douglas Tsao

one. Okay. Then just one final

study think expect going additional clinical I end, of from potentially indications as where into work year risk in one thinking been pivotal haven’t that an in the done initiate disclosed. to that, you reward indicated by you of sort necessarily terms haven’t you are one, you trial pivotal indications that two much mean, I about previously? how

Pete Salzmann

second -- into question, an go pre-pivotal great but trial ways pivotal decision important a in a question that’s That’s directly second the a trial, Doug. some whether or question. on Right. The to the question,

success And in not consider technical we are success, your think they’re the data we the which probability good obviously, the also new The obvious. stating is There addressable a since then we’re important the want development ourselves degree looking such for question biomarker, anti-FcRns, patient the only but develop, we technical first to our size ask highlighted at population for thinking a that indications probability you of question. need, the maybe from about what unmet programs. is is we’re the we own most therapy. When of anti-FcRn of of data

for data stronger. our pre-pivotal making pivotal, have faster certain is to of then leading selected trial advancing a to long and So whether get indications prioritized reasonably of you chance some value that to which the BLA, and but a that having has creation, our or is of the also, for additional scientific and list next a because indications, the whether straight has go potential term do question we pivotal to three understanding pool generating and program catalyst [ph] long then disclosed, that’s beyond great we’ve a

I ultimately, going that’s morning, avoid be Rigel’s more issue to criteria then little trial, you most strong optimized, think announcing if desirable. having what an having that’s a pivotal important thing, this a really, inclusion/exclusion in really your bit like your can by result the

For some the difficulty] of and [ph], to the be indications, there most is a little bit that value less [technical scientific creating. approach do information,

is most and So important indication, or second it’s which pivotals the most the thing whether pre-pivotal. thing important

Douglas Tsao

Okay, much. you great. so Thank

Pete Salzmann

welcome. You’re

Operator

you. Thank

from of Guggenheim Yatin with the Securities. proceed comes your Suneja line question. question next with Our Please

Unidentified Analyst

[ph] Two ones is for Evan on Yatin. quick for Thanks for Hey, taking this me. questions. our

bar First, confidence for is to can And seen? some second, that you gives remind the TED? in of you what move given us the forward TED, what prior mixed results you’ve

Pete Salzmann

Yeah, Evan. great questions,

greater is Tepezza controlled bar an the as is robustly data, think data equal of well characterized or But see around had trials. very steroid two I obviously, with as have proptosis generally on which for So the than you to pivotal not efficacy XX%. steroids. And what efficacy steroids response

think lies anything I will the is efficacy tolerability So profile medication for strong like batoclimab a believe with between the where bar a have. result and we the new steroid Tepezza

really a lot confidence triangulating Our comes information. of from

trial, So to pause midstream, We difficult patients made had data trial. to had degree throughout had it interpret. our exposure varying of we Xb a who a lot the which the of

which there various the So trial, at hit, scores rather as more it where see you across lot trial, would looked and evaluate endpoint, biomarkers, primary as the response. dose at look there’s gate if and clinical a and it than proof-of-concept the first to whether you looking you then secondaries at is of information statistically look pivotal where it at is would we a triangulate consistency a you significant,

and see response wonder or most that, a that I something you like a when the a for that’s decision proof-of-concept. Because you’re if things seeing in dose of one think results making important smaller the a markers inverse if you at lot we little R&D trial then observed of the a dose more clinical saw that our radiologic today, parameters, response, are as and in in day. we bit slides Across I highlighted detail and even biomarkers spurious. a

and that that hit efficacy. strong to of terms in us gives bar a likely that we we’re the outlined conviction here that I So have an effect

Unidentified Analyst

Thanks. Maybe just one quick if it. could, up. follow I Got

For that the each in total data, of that analysis? included number arm what hoc in is patient proptosis post proportion

Pete Salzmann

what you there randomized, in the question to who were weeks tricky a who was everybody not XX week put the that That’s to everybody put and denominator? got do people answer, XX finished ever some weeks. because XX, You

week got XX say week generally there I or half many X So as about is to just later, that the to as XX. think week people

of So put you it’s of smaller two in to number depending the people, a on what sort half denominator. thirds,

Unidentified Analyst

Got Pete. helpful. it. Very Thanks

Pete Salzmann

no Yes, problem.

Operator

Thank session; any our to you. that Dr. back final Ladies floor the Salzmann gentlemen, question-and-answer turn I’ll and for comments. concludes

Pete Salzmann

us again for Thanks Melissa. Thanks this joining morning. everyone

the this opportunity this unique opportunity much by it very first-in-class excited really you to in discuss We’re appreciate TED. bye. with Good I all morning.

Operator

conference. today’s concludes This you. Thank

time, your this lines thank for participation. you at may your You disconnect

Immunovant (IMVT) 9 Jun 222022 Q4 Earnings call transcript