TCDA - Earnings call transcript Q1 2022

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Operator

Good day and thank you for standing by. Welcome to the Tricida First Quarter 2022 Financial Results Conference Call. [Operator Instructions] I would now like to hand the conference over to your speaker today, Jackie Cossmon of Tricida and please go ahead.

Jackie Cossmon

Thank you, Didi. Good afternoon and thank you for joining the Tricida first quarter 2022 financial results and business update conference call. Klaerner, on CEO outcomes the discuss business Gerrit provide President, trial call, our update an ongoing progress. today’s our and Founder, will and In VALOR-CKD renal results CFO, financial our discuss and and guidance. COO our first quarter Parker, our Geoff financial for the review will include laws. that that today’s various in defined as note we will statements Please making under be call, statements forward-looking applicable securities

events, results subject achievements clinical the activities well include to will to our correct, our line Tricida these endpoint outcome undertake our trial, update to these these expectations do renal assumptions, of performance future termination prove anticipated top related statements. runway. in from discussed can opinions duty that and not financial be to timing trial, intend risks such statements or as results, estimated early any give and materially forward-looking uncertainties forward-looking reflected actual statements implied Forward-looking VALOR-CKD including of to regarding the for cause in differ accruals anticipated by or are ongoing assurance statements statements. and no Management’s we our receipt no expectations as that data and and may

associated We Securities this our afternoon read risks also financial with release press We after quarter described results Exchange the urge issued are just our close Commission. filings and you that and uncertainties business the market. of to in with our the first

website information Relations and page. call press slide go please updated we our release this www.tricida.com I the posted that to call. Gerrit. like release, follow note Investor on link also to have At press our presentation time, of and to that of the from copies over I’d Investor would to the updated For our our turn Relations includes portion an

Gerrit Klaerner

joining for you, today. all and you thank Thank us Jackie

make the VALOR-CKD continue trial. We good outcomes execution progress on our renal of to

accrued XXX or disease, X,XXX events XX% renal average approximately primary adjudicated months. subjects an or has endpoint X, treatment end-stage glomerular than subjects equal the with in defined estimated May ESRD, rate, XX renal of The greater duration of filtration to the positively eGFR. trial As in randomized as trial had reduction death,

anticipated trial reported, results for primary VALOR-CKD in of third We quarter on XXX As rate primary continued the the analysis of financial reasons the approximately early in on months the VALOR-CKD accrual runway, to Based the stop early of of are trial will endpoint updating XXX. previously based endpoint number we the allow our runway events the the event administrative following from adjudicated XXXX to to XXXX. the fourth in line second intend X announcement. for positively top quarter reporting subjects final which quarter with we with financial current trend, events anticipate we of XXXX, of into

could evaluate lower. events or will provides for metabolic which X.XX of XX% Assuming for there a We if in Geoff observed XXX the presentation a to with acidosis events, patients be has corresponds endpoint analysis, turn that, to are an ratio CKD. power. the trial we the XX% the power financial is to observed ratio true ratio successful in are progression if ratio hazard events with events, analysis, CKD XX% of I quarter. with And observed hazard X.XX the XXX reduction placebo the from the Switching final overview treatment is that results of trial final events our in how X.XX, the power. if with veverimer XXX if to and there With slowing data the impacts and XXX interpretable hazard hazard in lower VALOR-CKD statistics, or has the believe veverimer

Geoff Parker

Gerrit. Thanks,

million X months drug connection the of ended substance million The XX, $X.X non-GAAP expense XXXX for March activities $XX.X $XX.X our million, XXXX development G&A $XX.X of million expense with G&A million quarter decreased was in and with and and was in million was the expense due the to and March were The costs. million related due and R&D first our expectations expense $X.X $XX.X XXXX for the XX, and and Net R&D XXXX, months XX, primarily with ended other loss results and lower and manufacturing legal was months loss was clinical XXXX, clinical net ended primarily million March X to in for decrease in decrease X fees. veverimer XXXX respectively. respectively. line $XX.X to program and Our $XX.X respectively. consulting development

turn XX, resources of the will March X operator to the believe of for which questions. financial the cash Operator? into operations and were current anticipated investments second of XXXX, We fund to announcement top equivalents quarter our XXXX, cash, over I approximately in million. the that, will months As planned VALOR-CKD. is call results early With be for from our $XXX.X line

Operator

Instructions] Thank Nadeau comes & first of Company. Our you. [Operator Cowen proceed. from Please question Phil

Phil Nadeau

afternoon. our Thanks taking for Good questions.

for question you, financial Geoff. a First,

expense, a lower is this seem ‘XX than QX were bit you we R&D cash if modeling, it your R&D consistent get the like to On does runway. expense, that’s was though it how

similar R&D through that end of at So, of be least fair will the the kind at at are levels we to through XXXX? assume –

Geoff Parker

an is $X QX. QX be So to in estimated $XX uptick uptick similar somewhere and and million QX with in QX probably Phil, for QX million R&D between to

out. that’s will speaking, roughly the how year trend So

Phil Nadeau

helpful. That is very

on Second, VALOR-CKD.

Geoff Parker

that’s fact contract By due there, Patheon lumpy. the with our just to that is somewhat way, to add the

the why fourth that’s tick up So you see in that quarter.

course, up VALOR that time. ticks down ticking at of will the be as Patheon go And fact, trial In if planned, then. things

Phil Nadeau

Got it.

a modeling. helps with That lot Okay. our

with like accrued the bit were suggested there the it over XX size reason dealing behind that past, the to and trial, just XX of month. which X in in maybe that Is per have event is events is uptick it identifiable the looks VALOR-CKD? maybe rates were XX Second last any months, randomness on the or you higher there events VALOR-CKD, – little than a

Gerrit Klaerner

This just a We April. think, March over I X last see as – before now, Gerrit. events in we No, is in I do said, in more or and I XX had, XX we X think the months, then events. month

still but primary why number modest we actually events updated in it’s the endpoint that’s the uptick, think projected analysis. I a we have of – final

So, uptick. we went say now To XXX to from XXX. I the to accommodate say I are XXX seeing, that to would XXX we wouldn’t this, robustness

Phil Nadeau

Got it.

simulations X.XX Okay. XXX. calls The slides And observed a significance you last hazard XXX XX,XXX suggested, calculate you question those referenced, – benefit based you – of it numbers. on on X.XX for specific more the ratio about and ratio necessary out, were VALOR-CKD, then statistical in for ratio between in used that observed to to events calculate like the hazard bit go as as to you of Can VALOR-CKD? the did that’s hazard again exactly talk detail how maybe slides a

Gerrit Klaerner

Basically, bit a plateau. to is you random statistically order a above variability results. trial think run look hazard look be if what below thousands the or said And of be at you then at consistent a that that and with tens before events significant. XXX in I simulation really ratio, think, you I the or of the times is the of where look at really, in in And we case you what’s to need threshold hundreds or the

hazard XX X.XX be think of higher And we every with X.XX. thereafter As ratio you for of significance hazard may sort been a of XXX would I events remember, to X.XX, have threshold so see, gives it’s events, statistical have around can ratio. you able with

add And so you in and are here XXX of helpful illustrate scenarios. column the this to potential this very table seeing to the it’s think range sort of event I

Phil Nadeau

time is In ratio, hazard like or some it’s at the simulations, significant than significant at ratio there threshold like is those it statistically more that statistically XX%? every hazard

Gerrit Klaerner

is Nothing XXX%.

something always I think or XX% give they this. like you

I with our on I estimates but based And statisticians, think conservative, so back can those simulations. these are check

Phil Nadeau

the So, the taking questions. majority be Perfect. time vast for it our Thanks static. would of

Gerrit Klaerner

Thanks lot. a

Operator

you. Thank

question comes of Fye from proceed. Please Jessica Our JPMorgan. next

Unidentified Analyst

for This afternoon. Thank Jess. [indiscernible] is good our questions. Hey, for you taking

can down then there would be from the part how runway result? of us for potential potentially line assuming line you. any top So, guidance launch And us, you thinking the prepare couple line top how extending would Thank results, a assuming you and financial filing regarding like positive about further is internally? give of you

Geoff Parker

So, timing the with about regards resubmission to of asking you the of PDUFA your first question, were and date? part

Unidentified Analyst

Yes. And internally? is there preparing like is potential also, the about thinking then anything or for to you are launch prepare

Geoff Parker

Yes, yes.

assumptions. So, updating and commercial reviewing commercial our are we plans, always

as over that doing few did last are we next well as months summer. the So we

the announcement any of That’s overall With commercial a the prior PDUFA in on would So, or spend review XXXX. QX we the filing anticipate would speaking, background date launch we study QX regards have potential update QX, ‘XX a potential VALOR our we data, and significant resubmitting expect in we timing to don’t we are in XXXX. And of in to to of have resubmission. presuming a QX launch, NDA then have while towards doing plans for a roughly commercial. have work to early of commercial for X-month

of XXXX. regards on positive and first I VALOR-CKD, plans year. our the of plans based capital presuming to the So quarter into discussed QX we will as year data runway, capital next on part earlier, we sufficient put have current into later this early motion of With through those

the at that of to our warrants year. end We also were have last place equity investment in direct related

the we a into above address those in data have announcement the after a capital. price the announce positive to an warrants, further fact, So, trades additions warrants volume of of And have bring think VALOR-CKD with data. would weeks million regards million share expire outstanding that VALOR certain $XX our after with requirement. we those would X which exercise exercise receive to price with take if, with in reaction But will the and capital, XXXX assuming XX we I through and would warrants X per we good of us data, to any to to the $XX stock late regards opportunity VALOR-CKD

Jackie Cossmon

Operator? Okay.

Operator

Thank you.

question of Kumar Please Goldman proceed. Sachs. Our comes Madhu next from

Unidentified Analyst

This would quicker or data, wondering Thanks stone? for your in events that change Hey, was already expectation is anything is guys. or for slower I just top on there our like that of line is for set taking questions. Rob the Madhu. accrual

Gerrit Klaerner

Yes.

of what remember, targeting to really is our not X top I and just line of it’s we around have stuff driven data really the number left. sheet think sort by think I this driven that cash is by a certain discussed months – events. And administrative of balance the the

nothing So accrual the the of of really top has event to correspondingly, and the timing timing administrative stuff with line do data.

Unidentified Analyst

And for question, release the post be just you. would line? Thank data what one the the cadence other Okay. top

Gerrit Klaerner

traditional. very think I

initial the the the in press release, obviously that we between playbook and endpoint not going at positive primary the appropriate we obviously, it’s think put will look said and top as if journals, – have think reinvent we data, here. into to appropriate what’s I what’s into of I – are to then one

Unidentified Analyst

Thank Alright. you.

Operator

time, you. I’d Thank Cossmon like to this back turn remarks. At closing to it for Jackie

Jackie Cossmon

and Didi today. thank us you, Thank all for you joining

us additional e-mail goodbye. As you to please always, at hesitate if have ir@tricida.com. Thank questions, you don’t and

Operator

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

Tricida (TCDAQ) 15 May 222022 Q1 Earnings call transcript