Immunovant (IMVT)

Pete Salzmann Chief Executive Officer
Frank Torti Executive Chairperson
Thomas Smith SVB Leerink
Sam Slutsky LifeSci Capital
Call transcript
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Good morning. My name is Melissa, and I will serve as your conference call operator today. 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 conference is being recorded.

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

the I'd the include efficacy not of including and the and are within include, for Before anticipated. conference or trial, and Act of Private materially of safety future begin, like clinical statements timing, future indications. forward-looking which everyone and its Reform of various uncertainties, expectations results and readouts timing remind Immunovant we announcement unknown, differ statements or These that Securities from call Litigation will candidate These could data meaning regarding and certain those risk Immunovant's performance known the to statements subject forward-looking example, design product guarantees cause indicated XXXX. future assumptions, to forward-looking regarding of of actual the statements to are today's the potential of results

report most investors For XXXX. are information, quarterly August on the more XX-Q review X, encouraged Immunovant's filed SEC with recent on to Form

I'd call Dr. you, Salzmann. Thank over Salzmann. to the Now, Pete Dr. to turn like

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Pete Salzmann

million months higher share ended Net personnel-related General months expenses. for was months that XX, three compared per million per XXXX. data that share highlight year-over-year increase million to compared loss I with you, always our three that expenses from that million, limited want to Melissa. results ended this a comments increase to today. June wanted $X.X I'd to $XX.X briefly R&D to and three to review, common the ended three three the to the months the months June our $XX.X take months the take Net XX, for $X.XX million that expenses. our the XX, several engage ended loss to to today for year-over-year related June partially respectively, for and the we expenses we the with interact XX, everyone ended for million that close discussion and program-wide to the ended typical, we've or our Thank $XX.X some programs. in personnel-related With XX, a opportunity expenses I the first and for net to The for increases ability administrative $X.X a by June investment community last quarter calls, over call development for or June XX, $X.X and and strategy. months reflected the that common non-cash the XXXX, go-forward than the three XX, Research in do to financial June for will XX, XXXX, were thank on XXXX compensation June activities not primarily higher that around have but The quarter million for dialogue ended to clinical XXXX. were call G&A. $XX.X and contract costs. XXXX. was earnings do fiscal XXXX. joining the start $XX.X million lower offset more begin June three The quarterly opportunity expense. XXXX, financial ended because I realize months due included $X.XX with highlights loss. today primarily analyzing brief and the of results reviewing that, data like recap our compared been stock-based manufacturing related XXXX by

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Frank Torti

you. to company it's Chair management this as Thank pleasure my And the support Immunovant of on able express a the of be a only the in also for and investment, excitement not to today the representative as call and join Executive team. but Roivant you

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on for back me call comments. with some having Pete today. I'll that, for additional thanks the to it turn So And

Pete Salzmann

That's a Frank. Thanks, great overview.

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pursue by this As to across XX very of a there ambitious Frank I'll regard the indications with specifically for the providing actively anti-FcRn being development. the update we've are additional MG for to just People studied that time right our I parallel to that meaningful we the Frank year, are alignment program With that excited with reiterate the end expect about well this mentioned now line agree earlier, that's FDA. strategy. and the updates, class, on achieved provide remarkable. is strategy We're class, positioned

to same TED will be go XXXX. for We early XXXX, later the of programs ready do are our expect new WAIHA Behind thing regulatory with once that indications and our in in announcements alignment. these to

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proceed Instructions] the first [Operator question. line Karnauskas Truist Securities. Please of Our Robyn from with you. Thank with comes your question

Unidentified Analyst

taking morning. Thank [ph] Good This so much call. guys. for Robyn. Hey, my Trepan you is for

in. talked XX to talk TED, the So a you are that but Maybe these Can trials plays beyond mentioned a you Is one pivotal you. TED just of being behind little indications? And too you out be said these about see talk do in little that about trial. the at you plan it, it's maybe evolve least indications. rationale Thank and expected - you about TED? the then XXXX least in little a And if bit way to you initiate a the of talk how indications selection trials market the WAIHA? in PR at can early will two that all confused, to investigated clinical FcRns MG,

Pete Salzmann

great A set questions Trepan. Thanks, there. of

the with And selection to which pretty to pursue criteria. are So to there How the mentioned class. entire indications the is we're think across most technical a much will a how anti-FcRn select of next? disease that's degree first, particular patients. then one indications doing, of type first your our different going good mechanism question of as success, two opportunity is the elements we being clinicaltrials.gov now XX in probably unmet classic fit probability related to anti-FcRn I how important analysis the posted there I for question, need, element. the that secondly, benefit we're that of And

In endpoints. the of then factors, unique addition, consider the clarity window subcutaneous therapeutic I the including some factor. logistical form really And features discussed, simple of broad we'll of XXXX course, and the that regulatory other like

an to all validation goes decision-making. to we we first-in-class. our So then clinical another indications, set by best-in-class, already and been we where Ultimately, be of that be perhaps want some opportunity into there's some asset, can indications have of a have where which

So I TED our With and to MG regard a WAIHA, to indications. think - of of that's one for around your pivotal, statement one - for that new apply the could indications the being or your first question. beyond

about thinking in previously that in will And MG. And as indications four announced believe then a have with trial we'll XXXX. trial we're group. pivotal of So also the pivotal a one we begin them those

programs that's in So XXXX. pivotal two

Disease, I it's of the good interesting for there extreme were Eye wasn't think just It's therapy was for market. there who auto a of regard sure, really Eye surgical therapy. long and time but a Disease, with there medical antibody Thyroid impact good some good wasn't Thyroid a really, just There like therapies, Finally, a many had for a conditions, patients to therapy. -

of lot short other And a having their Myasthenia need are is, impacted Thyroid for patients six indicated of for new of lot launch and a something is achieves with innovation therapy, therapy that the benefit. month a Eye term teprotumumab, after Gravis. and And months. patients as studied for But condition this chronic to the physicians unmet degree stopped. are like with of opportunity some of of think marketplace there which course I is and Disease is still been after So not what six experiencing of relatively of that course, in advent a therapy great. as response, is the patients high relapse initial is Teprotumumab proptosis

of this one evolve be treated possible. that situation time makes as over where maintain many normal, me close - and to with close response market of sequentially that be, to all think than action mechanism to well a can more long will as get as So will patients as fully that as patients them they to to

Unidentified Analyst

Thank you Great. so much.

Pete Salzmann



Thank you.

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

Thomas Smith

Thanks And Hey, dosing, taking communicated? being and the guys. XXXX the Good thanks first, guess, any in collected to we so, morning. of that additional I analyses conducted there the previously can see expect questions for for data? terms when update. on if these analyses are are

Pete Salzmann

that for question. Tom, Thanks, Yeah.

the regimens might taking understanding how pause us to totality from data and an that continuously give obviously, with rationale we modeling. models we prior PK/PD are our for dosed the patients studied who know, refining of XXXX we all yet in you perform. dosage So that of were have the That's to the haven't dosing as

XXXX. dosage and of information and regimens, would new any regarding at of we're models that to R&D going output potential of the including expect of our forward. dosage a yeah, part protocols, Day looking regimens of So our would inform be And I the expect those first different our quarter in protocols detailed the design lot our we

Thomas Smith

around what And trial pivotal to idea relatively pretty the factors the sounds share the you're you you. you are else with having then close that the and in alignment design what for us Thank agency? sense. of - I terms of perhaps study with would makes MG And good to that to study. like major able be feel a study? it gaining guess, I outstanding, details That both what gating, then, Okay. the guess starting

Pete Salzmann

right. Right,

So I indicated, of of induction in an in I mean, lot a type maintenance of protocol as the think approach. see opportunity for itself, I terms I've

final think is will which the any will - protocol a of course alignment I with on on, have the achieve ultimately that have, FDA feedback they flavor. that dependent So have we

have this logistics FDA it's really of at point. we and alignment terms that In through gating the with of the gaining back and factors, just work forth the to

Thomas Smith

And last then maybe one Okay. Pete. question,

In restart can I in terms agency your Disease the Eye of, to with any overall feel WAIHA different of and maybe gating guess, I speak three the programs? being outstanding that to, Thyroid you if you factors engagement divisions, across terms like guess, other able are

Pete Salzmann

same just right. mentioned really what the Right, Gravis. It's we the Myasthenia most in I Gravis. Myasthenia as Obviously, element for data have

so a And that's - meeting having of an start, completed is that previously. division with end place to Phase-II the good

first interactions the so and any other with neuro will division. interaction one, then background with will information there's host the interactions be same that of And lot with that a the a whole interaction the that will via the of be divisions And follow. obviously the and is for first reviewed agency the

Thomas Smith

for taking the Appreciate Thank great. you. questions. Okay,

Pete Salzmann

problem, Tom. No Yeah.


you. Thank

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

Unidentified Analyst

morning. for good taking Thanks Hi, the questions.

levels the just Just, sort think change you. prioritization, Thank or will flexibility, that of be LDL indications dosing through of of managing levels Pete, you is and needed? given any there thinking, and as and been terms in albumin some

Pete Salzmann

by across a came our we the Yeah, the conditions. little final immunosuppression immunology down for our maintenance minimize June big think is as variety preparation by optimize phase. efficacy we the insight XX-K. I call just optimizing within the was doing and came And Xst honestly, were really And in rooted, what finalizing immunology indications, treating and tapering in patient's bit Doug, want efficacy that long-term a wide to to of with hard then upfront induction realize, you that

across of mechanisms and wide So indications a really is this variety the maintenance phase to efficacy. induction used and optimize

the of efficacy because, this standpoint, asset. and new are realized that earlier one attractive an IgG most and today the from different I think PK/PD primarily models mentioned albumin We always any I things was for then is and LDL So important for also approach as albumin. previously, for

So IgG. down get the in albumin you to dose as of a much the fall-off compared you the [ph] reduction as the impact, steeper step

achieved for be therefore, still dose. reported had XX% a LDL, So impact XX% that we a speaking IgG chronic modest of reduction. the mid-range really the LDL, for increase that XXX median reduction a much dose, that sweet while about where to for dose a decrease allows in a more on having IgG in good albumin Remember, spot albumin sort dosing more have and and, dose a XXX XX% with a in

think I So to indications. forward in that's really fundamentally lot what of great a going provide us path a is

Unidentified Analyst


limiter this or you And at don't see not a in clarify, pursue this may so of indications to really being may sort of just so you terms what point?

Pete Salzmann

ask again, because, term, goal we're get know of nice induction to and the the control, true to a point you're aren't who of a goal there'll is going really asset. hearing the the that's in under for short the symptoms but patient whom physician you topic. when a small don't suited. as thought patients - in that the really And not - he's phase, of for lot not yet. can this around I the option. LDL patients medication appropriate, changes ideally Maybe any of of albumin of be will short a some majority percentage patients be it's Frank whom make be even to really certainly or Frank, There'll for I'll that this be a well. about that may be I percentage small term a a efficacy. then large There who be

muted. be might You

Frank Torti

you. Thank

had the obviously, nipocalimab for thing this think And manifests, of field - thinking are who go within right. has the patients adding exclusion see how unstable J&J. weeks released angina, myocardial with I others aware didn't to these just protocol infarction, stroke than if you from been by example, Phase change or in disease criteria about we're wanted for other heart XX the the other is of They forward have screening. much issues, of, that an III design in some they the

thinking other companies And field of FDA points. lessons of clearly, kind So the grappling and with those with from taking we're the how kind similar us are about in go forward. they obviously the issues

Unidentified Analyst

you Thank Great. much. so

Pete Salzmann

Thanks, Doug.


Thank you.

question Capital. the line your proceed LifeSci with Sam next question. comes Our from Please Slutsky of with

Sam Slutsky

Hey. Good for the everyone. morning, presentation. Thanks

me. for question one Just

to see what discuss II like? prior able might we design And of next then and the in from resuming WAIHA steps? to TED, can and general of size to for Phase terms In are look expect TED, the data next study you studies development

Pete Salzmann

Yeah. Sam. Great question,

from investment thinking. us obviously flexibility our million lot allows $XXX the a So Roivant in of

best approach conditions about steps in want ultimately terms learned a those is both in and indications. context we've achieve, we of the in the way those So to next to what of differentiated we're what context of far approval of which the thinking in so

specific not to more that. able I'm yet So get beyond

the Thyroid data our in trial, FDA granularity don't we'll that. In releasing terms next on alignment to prior gaining Disease I do of Eye with think the the greater

next a that what I using our at in think right have confidentially design a lot probably some time to the we've information poring on Thyroid that time the of that that, now and we to for that advisers trial design be announced - share Disease. we observed. that next would then more we're over with good And design Eye detail trial

Sam Slutsky

Thanks. it. Got Okay.


you. Thank

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

Unidentified Analyst

This Yatin. you Evan taking for Thank Hi. is questions. our for on

the trial I You And up Is take doing potential have again? specific that know, the dosing steps a quick you're you're mitigate in what in beyond LDL starting there anything TED to regimen? the follow-up. then issue adjustments you that would

Pete Salzmann

Yeah. Thanks Evan. that, for

Thyroid little Eye shorter unique in of that likely bit Disease duration a it's a So is therapy.

may other medication. period resolves Disease a is don't could Eye which phase maintenance just somewhat spontaneously. and is of have essentially Thyroid the That's off condition then that a the resolve versus many be makes sense many, conditions versus So that over self design, a which induction, teprotumumab in condition the years this - limited.

that nothing shorter for duration, it that So a particularly management, may of particular there that be to briefly done are in criteria Thyroid given in likely as be changes, role term in given some That the majority really the is is Frank modification highlighted play remarks, I then prepared modest think for is of anti-lipid with we won't be inclusion, excursions in needs programs the to that Disease an you'd Disease which term patients, issue. that of be dosage LDL things Eye his or a shorter vast Eye Thyroid dosing that could imagine exclusion therapy considering said, lipid well. and kinds

looking things will get is stuff six months the finalized at and here. that over all So we're next

Unidentified Analyst

quick one issues where indication you indications then within know, indications just FcRn a across mentioned of Are subsets XX currently space that And in the Got these that lipid the follow-up. big or it. particular there of you being are patients investigated that not are deal? a

Pete Salzmann

Yeah. There's a wide comorbidities. variety of

conditions, as conditions. many data more some XX, of of conditions, you across all if the actually there the that of for sort there's a in significant. For autoantibody find the general not not certainly, most total autoantibody are as because are of variability. significant may body autoimmune inflammatory some But look of you'll And comorbidities the be that

just I point think LDL keep hammering most is term not at kind in short [ph] are changes though, vast the of home of majority patients. maybe for that concern important to the

a with important associated can think achieved term when with consideration, with such IgG going if because short So be higher be of is efficacy I to that's that XXXX. there's particularly reduction induction, that short with deep an associated in not term change the induction excursion

Unidentified Analyst

Got it. Thank you.

Pete Salzmann

problem. No


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

Pete Salzmann

Melissa. Thanks, XX the really indications today's a remarkable market sure on our really, I'm class, call. announced hear opportunity, unique, can I enthusiasm think. joining across I appreciate based it's you everyone really Well, just

sheet, development a strong day. Have based broad based simple balance also is form And an good a ambitious us enthusiasm pursue to injection Our differentiated parallel subcutaneous with XXXX profile Thanks, program. on now a on and window a therapeutic factor. everyone. enabling


Thank you. today's This conference. concludes

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