TCDA - Earnings call transcript Q3 2021

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Tricida Third Quarter 2021 Financial Results Conference Call. [Operator Instructions] I would now like to turn the call over to our speaker today, Jackie Cossmon of Tricida.

You may begin.

Jackie Cossmon

Thank you, Marjorie. Good afternoon, and thank you for joining the Tricida Third Quarter 2021 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 third 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

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

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

At For copies I'll go page. release, this call to Relations to press to please Gerrit. time, www.tricida.com of link turn our Investor and follow our the over the

Gerrit Klaerner

for you of for and stock to Jackie, you, future today. plans all announcement thank us our our to VALOR-CKD. I'd regarding Thank turn joining like today first administrative

insufficient based stop to the financial potential early have We about spoken resources. previously on need trial

necessary would substantial events, that such of have will or until not able target not endpoint to adequate there a reasonable release, primary time is obtain press As you we frame we to the positively VALOR-CKD saw reached we which adjudicated current reach on XXXX. in continue subjects anticipate to likelihood the be XXX terms resources with a resources believe be in that

cancel was such, early Type the As meeting terminate procedures for that the as to likely which and We stopping and resources is FDA considered, with Type VALOR-CKD the us based interpretable key granted to a allowed various out. received trial administrative Tricida and requested stopping pursuant missing Among the alternatives close the to we of thoughtful most the discuss analysis clear reasons financial study feedback the the provide in indicated efficacy of and on considered complete have the A required risk and the to we meeting. that for data, data FDA's options actual existing believe for approaches maintain to preliminary the VALOR-CKD A the protocol early. trial. to reduce integrity FDA comments,

by anticipate be stop XXXX. the determined the timing will that While the of administrative stop financial exact we will administrative half occur of in runway, our first

trial. the Our the have enrollment in has approximately in yet not like we receipt financial of maximizing on trial for the subjects of X VALOR-CKD runway upon FDA, Also to of goal data. the will on the trial based the of feedback hold patients from is additional months enrolled in follow-up determined. resources focus duration to stopping and I timing are order the currently been emphasize that who to would the

We an with we accumulation endpoint to to the most when We've of trial. new and will year. can we in the good made execution of focus believe intend We the and objectives. on date continue even that address our events trial primary on VALOR-CKD important early move are termination, we have information progress the successful runway the evaluating our into financial additional as stop should trial

the event, first, progress treatment date, primary an renal the We've VALOR-CKD outcome good made The the XX% a very endpoint American treating to approximately XX XXX trial to in integrated slowed subjects duration occurrence EGFR. time metabolic that To show acidosis, reminder, the the CKD of death, with renal very is we first progression. trial trial. average a ESRD As confirmed to of of designed have DDXX months. in reduction is final randomized over the

accrued have with will with that events. adjudicated we positively primary on us approximately We endpoint primary subjects XXX track mid-XXXX. and still by event rate anticipate subjects events This with our endpoint XXX we puts projections reach

of are anticipate XXX-event interim likely we stop in not conduct would XXXX. the Overall, that However, prospects half we to of analysis. we occur the the an protocol-specified VALOR-CKD. excited about administrative first Accordingly, remain

in lecture primary from a our number believe with reach prior a to that main chance trial we contemplated, fewer even that Given have are the our originally own of objectives. studies, results events endpoint we

goal First With with I'll our Geoff financial overview foremost, chronic to slowing disease show and of of kidney that, our the quarter. is presentation progression for an our the for turn veverimer. results to

Geoff Parker

Thanks, Gerrit, you today. all us for and thank joining

million including with and due in development September was connection the $XX.X September respectively. for to XX, decrease clinical net medical with $XX.X respectively. our was $XX R&D personnel with the expense months XXXX, our primarily program drug and The XXXX, line in was of veverimer ended decreased for was and for and $X.X X $XX.X our in G&A million X costs. $XX.X program, were substance. related XXXX million the September connection decreased ended non-GAAP XX, XXXX The and million results ended loss manufacturing manufacturing and and pre-commercialization, million the process administrative to quarter months decrease affairs expectations, million primarily million due veverimer months development clinical third Net million, and and activities Our XXXX, X to XX, was $XX.X $XX.X and XXXX of with activities optimization respectively. loss

XXXX, equivalents cash, cash investments totaled of September XX, million. As $XXX.X and

of XXXX. million we $XXX We note with XX XX, XXXX. through operations million approximately We have our date resources a outstanding. At X.X% financial senior fund September will our outstanding planned XXXX, current a had shares maturity believe convertible

next stop of first financial administrative the the timing continue in of however, consider XXXX. evaluate VALOR-CKD to several the the will, as half We for runway we over our months

Gerrit we new to move will as over the stopping on the Operator? As questions. the the for year. the make plan I trial we indicated, With a turn that, into call to time has for decision operator frame

Operator

[Operator JPMorgan. first from line comes Our from question Fye Instructions] Jessica the of

Daniel Wolle

for This Fye. Jessica is Daniel

how elaborate for stopping trial you of for reduce could required First, would analysis? early us efficacy data the the risk missing

Gerrit Klaerner

in you capturing is of think and was This Gerrit, Yes. trial information early, create bias. there's Daniel. the that all No, there's when always risk I a stop collected to not trial the

how think the and chance working of includes have regards data, and that missing to and the on I interpretability is best for that we within what of are sort minimizing early to input to say maximize stop minimize this activities as bias really scenario procedures FDA in So data. to an meant of such the the from

Daniel Wolle

in least feel trial don't the push those your would longer. completion. a good at where know option the success to there more trial phrasing the investors of additional all to allowed mind possible to success I if like And little sure run if way their the closer behind it, could of improve lots completion. run seems Is to comfortable capital to raising longer trial investing not an Okay. in I'm but way your that is it you a that that it's

Geoff Parker

for and the would the even we given the -- months comfortable emphasize we our good at again expectations should we position. that with remaining performance of in I trial with is the that be receipt progress This Geoff. that remain remain cash the comfortable just of of trial, result X the a of data,

and financial now, that as position comfortable what very we're readout our to lead of with So the in getting on VALOR-CKD. can

Daniel Wolle

mentioned this to objectives. for you those last will the address elaborate able that are? what objectives And those -- one. Gerrit, Can most you be important Okay. for us

Gerrit Klaerner

and endpoints we of the that the hit means Yes. trial. secondary primary Really, that

Operator

Our of [indiscernible] next Cowen. line question comes from from the

Unidentified Analyst

Congrats the on with the FDA. alignment

the based your recruitment So tracking estimated far about look rate. event accrual line is patient my linear it continuing been will question to completion? internal is -- Has as still it gets so event And to on forecast? time even it the with

Gerrit Klaerner

us that on productive an of the to important think, and with Thanks on for acknowledgment FDA. topic that, important with Yes. the early FDA an a how have really I step the really, was to for interaction aligning stop facilitate

and it. about we're acknowledging So it, you appreciate excited Yes. we

have So you you if on corporate curve, as we we're look are forecasted. the presentation, at right go And to our that exactly it. events

projection. So that that are is really, really we good news. following And think I that

Geoff Parker

a have And updated note, as deck. the we

with if corporate the our subjects So is line our XXX expectations. website, it’s see go you to Slide you the earlier XX, that in chart, right and referenced can on Gerrit

Operator

the next line Company. comes from from question of and Needham Stringer Our Joseph

Joseph Stringer

event sort on interim from past, hazard event? nice of just stopping couple update analysis. given at and probabilities ratios us. of you In various background some the A you've your Can

you ratios guess that a that? of us updated terms experience a of the to guidance get would to the based little the and cash that it today would going be exactly and you assumptions? a number success administrative are like on make Is your you I Given factors to when plan secondly, you on some Maybe in could what on decision that on your early. more to just patients, terms trial has then your sort provide stop, could in changed hazard on you And powering commented -- that. of probability powering guidance updated elaborate Or stop bit of runway? of on helpful. certain based into

Gerrit Klaerner

question, good Joseph. No, Yes.

interpret done all events, of we've driven assumptions, the considerations a and events, just certain of and using the sort can be to over perspective, be a all a I is from get clear, number of data, think all number perspective the runway. only you to smaller to number in this past and sort even all and now financial that prespecified though your order from still protocol the education -- months, by basically you're all applicable. the of But a valid statistical regulatory

of can't say, for sort events. you aiming I'm certain number So of a hey,

of I've to protocol you that FDA. there written so the XX-plus still we of actual the remember sort around early meeting. of clear very stopping So maximize you years. really the because, the I an again, for time administrative And of is because again, want everything rules this it we don't in mean, from time our still some basis, be presentation financials. very applies. careful that modalities are but I that comments by need the doing interpretability and basically And context that last stock don't follow to in is been And driven preliminary can the -- the look, get on the we need corporate and data. we But the solely

So this just happened.

still A preliminary response written us we that quite meeting, mode preparation which give the frankly, with. proceeding happy time, -- from are so were we because now for the in with some we're actual helpfulness So Type the not

aspects financial stop. other gives us how, determine it we're that to work so through the going And chance when to the not a the all but

Operator

There further at are continue, this Please no questions Cossmon. time. Jackie Ms.

Jackie Cossmon

if us you. all don’t us please questions, additional Thank to for Thanks ir@tricida.com. you Thank at again, as joining and you And always, goodbye. hesitate have e-mail today.

Operator

and this Ladies Thank concludes call. conference gentlemen, everyone, today's for participating. you,

disconnect. now may You

Tricida (TCDAQ) 8 Nov 212021 Q3 Earnings call transcript