ARDX - Earnings call transcript Q2 2018

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Operator

Good afternoon and welcome to Ardelyx's conference call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session after the prepared remarks.

As a reminder, today's call is being recorded. I would now like to turn the call over to Alicia Davis of Thrust Strategic Communications.

begin. may You

Alicia Davis

are and a Sandra operating everyone. today, site corporate Earlier The of Investors Thank company's the release Good outlining issued Web presentation current our press release ardelyx.com. XXXX in Ardelyx's we the press section you, at and afternoon available second results. quarter

is with On President CEO. the me call and Raab, Mike

Additional session. members the for Q&A of the us team will join

should to the not risks we important will described relied representing the uncertainties, to due statements make of company's to date current With section factors views call, related Mike. These update as materially SEC. expectations any the the our be as statements this me our in statements. actual forward-looking During are over risk our with to Form the that, statements no subject views and obligation and These let differ those undertake and results pass XX-Q future. as any plans. We in our upon and forward-looking risk filed of factors call, may including various represent of this call to

Mike Raab

Thanks, good afternoon and Alicia, everyone.

of first-half Ardelyx. XXXX evolution about has and The execution for been

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agreements we in to them programs all are geographies GI bring pursuing strategic our that worldwide. would For market

are efforts agreements. We our underway with several partnering established well with

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has believe we our of opportunity of estimates, million. are dialysis Based by that to on Using nephrologists million we our can is XX,XXX group experience, tenapanor tenapanor As X,XXX about U.S. the than targets building for in-center concentrated United specialized $XXX are to by the these in $XXX key led market on between in opinionators and efficient noted only There a less reach U.S. a States, earlier, conservative highly facilities. own. commercialize organization. a our hyperphosphatemia intention believe we which commercial

treatment or a hyperkalemia. program, is mechanism not portfolio also by potassium for whether potassium Our works which present potential it small-molecule the in represents different elevated renal have diet. includes to serum potential lower potassium first serum or may our RDXXXX completely RDXXXX whereby the the

over [indiscernible] designed to can of lower half the group, the potassium for dose in significant significant RDXXXX RDXXXX have binders. compared research two million nephrologists that one-one-thousandth an use. binder to allowing a been a and cardiologists data treatments also today's by Like hyperphosphatemia, have of treatment about impact, hyperkalemia. And compliance the for independent a note We according new even pill demonstrate to burden long-term tenapanor market has study XXXX U.S. as available for better hyperkalemia. there people estimate in at remains potassium with conducted need for Our preclinical that surveyed that

nephrologists we opportunity chronically to approach small [indiscernible] concurrent be With If medications. the early, RDXXX without marketing and for hyperphosphatemia the program. significant and use of treat we cardiologists a plan support to to that build sales advancing and convenient while for opportunity renal of that this successful, may to bring we believe format, look and reducing RDXXX efficiently successful program U.S. an tenapanor hyperkalemia the able allow the an leverage potassium is believe effective pill would in is our this to to development organization necessary we market to we RDXXXX a forward

early year. and program of Phase renal towards success our TEMPO working our for pipeline our X to addition quarter based NDA on this we submitting in IBS-C, are application tenapanor first and for the fourth the In

agreements experience be we like GI with through market track will our strategic stated companies to these that instead not assets, As brought for proven intend collaborations we commercializing has of and GI those and medicines. be significant record commercializing earlier, a to

Our Pharma IBS-C. for tenapanor exemplary agreement the Sun with with of and we patients with can Nice for are think benefit have

our combined $XX.X tenapanor as to million to is we've quarter the bring significant potential to agreements recent That gives raised spend the your royalty ahead open Sandra? progress NDA details in IBS-C as licensing our an in pursuing the in number I'm through Ardelyx confident as million more extended readout three tenapanor we execute answer flow for XXXX the on that, for for each total, and next these brought commercial upon call giving in the cash organization, such as in With milestones continue of milestones. $XXX and tenapanor questions. commercialization. tenapanor I us hyperphosphatemia. as we highly forward future as for will with to the critical potential well a development revenue on for look plan in us have sharing the non-dilutive the Our In data globally. well with year approval capital to patients for second and of the deals months

Operator

question from Thank Instructions]Our the you. comes Citi. line with [Operator Nochomovitz first Yigal of

is now Your line open.

Unidentified Analyst

potential what question. you color IBS-C partners on if first, our this in Samantha you what little bit a had on wondering with if just discussions in the for provide more specifically far you Thanks for I taking so you're could Yigal. guys, looking was partnership and have Hi to-date? a for U.S. is could

Mike Raab

Sure. Thanks, Samantha.

Let with me last the start first. part

come in saw is believe people GI, seen ago daily the our thoughtful we been capital, recently we've gone we've effort that CSPM, term as raise The clearly have water demure rise performance quite did with anyone of We will with ultimately the needed we've sheets, imagine, tenapanor people out IBS-C, the careful in dynamic would of for began certainly we until that be me tenapanor throughout. out now results. indicated And than IBS-C requirement wait that but capital. conversations we category smell get and we to not while out. which from blood is that would which diseases. TEMPO-X to needed and focus came capital we clearly was because data, access around I and on need and have and commercializing can perspective to as as cardiorenal you people commercialization the once have been TEMPO-X think happens none to wanted our as We best a launched, for that questions Obviously competitors and

not need those the will do, for approval back-end may to And that advantage to still we at ultimately And and with We and be if would it. that and a in did we to those will that ultimately of an of makes that both there where strongest us have mean to aren't table. believe we conversations in any any uncertainty we deal, we get milestones have post So going future. financing do royalties is interest all to ongoing a term parties on we something recently have, equity the label. doesn't My is position eliminate sheets. take participate to that the way there is approved do as the offset accept get we will that are here ultimately sense

that going they space, So all traditional in kinds are, that GI in the are companies you spoken companies leverage to that spoken of are to commercial we pipelines the that we something gaps folks from to to, know, companies who field. expect we've the the is are have is they would with companies have your in and range interested that have you direct that all are are that to organizations that going approved in

get will Some that optimistic kind expect benefit there provides we'll of ultimately the something something be us from and that relationship. we that done, would

Unidentified Analyst

bit that. more or for look one say have elaborate And same also strategic thanks to would U.S., partnership Great, be a in more territory? like what when it you you the multiple the may could deals little in

Mike Raab

territory can and what Yes, may we same Europe same is we we you and multiple the and deals be ultimately the those doing and so patients, just have that by States and States what that meant look after did territories United What be just want to best [indiscernible] much -- all or and wouldn't to that we territories there at will in make across get indication. we with IDSC deals is the decisions. do parties into United so Unite, multiple imagine the with parties

in do U.S. deals we two the wouldn't So IDSC

Unidentified Analyst

Great, to you. when for you hyperphosphatemia one thank complete? just And second anticipate study enrollment do more, the

Mike Raab

Yes.

New weeks hyperphosphatemia in the are two studies coming year. and we've We're [Indiscernible] So when everyone NDA. read right in the of on flat through. about part relatively enrollment this of goes also we started York end. that hit this year out an file next of the the headwinds the to enrollment ago we January is that what now we Those to will that data curve the guided

expect everyone once get we get a to to read out. So begin stick we as things expected. we that continue trajectory will when that to we the to tighten beginning we've of experiences, And hockey to guidance that

Unidentified Analyst

much for question. the Great, thank so you taking

Mike Raab

course. Of

Operator

this Thank you. at [Operator questions time. further no And Instructions] showing I'm

So call to for closing the Mike remarks. Raab Mr. I'd return like to any

Mike Raab

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

look thank you them. execution we're we Thank We medicines initiatives to focused a heard, questions, on of updated additional you, ahead as As to as need who the number in Sandra. of your have the to patients and you forward for we months bring successful you work important keep progress. make

Operator

you for the participating disconnect. gentlemen, program, thank conference. a conclude Everyone This great does all and and have in today's day. you Ladies may

Ardelyx (ARDX) 7 Aug 182018 Q2 Earnings call transcript