RTRX - Earnings call transcript Q4 2017 | Travere Therapeutics, Inc.

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Retrophin, Inc. Fourth Quarter and Full Year 2017 Financial Results and Corporate Update Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Mr. Cline, Vice President of Investor Relations.

conference. your begin may You

Chris Cline

Great. Thank for XXXX and you afternoon, Results Charles. Retrophin's Fourth Good joining Call. Year Corporate everyone Quarter and thank Update you, and Financial Full

Steve me Research Aselage, Chief Joining and Officer; Chief Rote, Development. Dr. Clague, Officer; Laura call and Senior the today Vice Operating Chief Officer; President Neil on Executive McFarlane, and Bill Financial are Head of

historical statements facts, I Litigation would forward-looking the that like made that during begin, everyone matters of this we the Before are Reform within remind not are statements provisions XXXX. safe regarding call to Act harbor of Securities Private

Please with from not are expressed may statements the unknown actual or company's as the disclaimer on risks, They statement. issued and guarantees today, our the in Forward-looking materially the involve cause known achievements and filed section statement those see of performance. and Form results, implied as that the assumptions performance earlier uncertainties differ forward-looking XX-K SEC. Risk well release press by Factors to

any information, that, addition, turn Steve. update date views XX, call only February made, specifically represent forward-looking circumstances. or reflect and Steve? our now the Retrophin are statements to future statements any XXXX, obligation such such disclaims let as to to me events With of statements the In over

Steve Aselage

strengthened in pipeline execute advanced efficiency our base our in each initiatives Retrophin. strategic We business afternoon the rare expansion our we of XXXX, we in you Chris. with to closer XXXX and clinical become disease have product grew for for seasoned on execution a priorities. Thank added members remarkable notably organization candidate everyone. to commercialization. development of year Through community. member Thanks, that our was our Good joining positioned us a team permanent today. to further our the Most pipeline and and we commercial ability

sparsentan with to we sparsentan. our pleased most pipeline. the to were very prior with you week items our discussion. on the planned progress important review agency’s Phase the in for FSGS. the in and regarding confirmed meeting Last protocol FDA trial recent Several met a our in of First live response clarified written to I'm update X

supporting concurred of partial modified that proteinuria in our and change Specifically, between our is proceeding statistical of the eGFR model the supportive the a link FDA remission study population this of in pivotal with trial H on our achievement Subpart bit Bill our a for key a pathway. program. into X FSGS but Phase will is the planned more detail go obviously slope shortly,

activities finalizing ahead FSGS moving the nephropathy. the our expectation initiation rapidly Sparsentan year. the patient IgA first in of X of Phase with study second also having are is in We quarter this dosed

enter in the this our in later sharing them parallel initiating for about to later to forward quarter, look these proposition for we two clinic, engage we and During prospects continued studies path fourth the to establish continue more kidney year. The increases value XXXX. to regulators sparsentan’s and preparations disorders will detail significantly trial clinical a of we our rare running

study program, pivotal enrol fosmetpantotenate X in which advanced The is development quarter, the During our for continues we patients. PKAN. fourth also Phase adult to

for year-end open of Censa second year. target of highlight the CNSA-XXX Pharmaceuticals last announced pediatric program the in of is was would We expect XXXX. but to patients This completing beginning study PKU. our like to to this at quarter all the with develop enrolment enrolment the enrolment around to I The collaboration

we through pipeline. the mid-year. of into look materially our extremely how advancing is promising By a quickly gives be, of complete strengthen exclusive Operationally, need fill pleased exceptional study the CNSA-XXX year then reach to of should and clinic to as organically around have early access the across Censa good a the efficacious we preclinical before proof has a a hypothesis with continuing The X XXXX concept Retrophin’s with strong concept portfolio XXXX. potential has and prospect team patients. commercial for data, to PKU are can million study. they Phase advance correct to a significant with we moving potential of the coordination proof work the if reads a very performance It $XXX the to guided this and into in understanding products pivotal to been of unmet $XXX forward to out, dosing study The grow with range We studies to development quickly the we collaboration us arrangement. look candidate million ended and the whole those our

our me now Bill? over pipeline Let detail. progress call go to to in more over Bill turn the

Bill Rote

Thanks, Steve.

priority pipeline programs advancing one with lead new with PKAN, IgA approved for rare nephropathy our few FSGS, PKU, number of Our and significant needs or therapies. remains promising diseases unmet all FDA

we year across During make an which us quarter outset progress very the clinic. XXXX, candidates, at our of XXXX continued the up well fourth for of all impactful of sets the to this in and

development nephropathy. kidney with for at least affect disorders Asia. of these dual both the people XXX,XXX Together, in numbers Europe and treatment candidate States start the greater FSGS rare mechanism me our Let and in sparsentan, advancing United and IgA

a Phase alignment the our to the X where on our with mentioned, with design H with FSGS. approval are agency, As proposed Steve we we gained recent pathway Subpart in support trial accelerated very meeting pleased FDA

for link filtration proposed glomerular population Specifically, between the the and proteinuria our that supports statistical estimated study or modeling eGFR. the rate FDA concurred

assessment partial evaluating time. over endpoint we a with proteinuria, confirmatory slope an of modified design, moving a trial and in of As discussed eGFR changes are result, our ahead remission interim previously has which of

great trial after having in a is alterations second the with our believe the trial we outcome. make before We in with depth. activities, agency have ahead speed moving patient initiation addressing and our this But first study We the minor meeting to anticipate protocol the to design dosed full quarter. more this during are

the Most we The to in sparsentan outcomes also cascade disease importantly, sparsentan show proteinuria, today the both multiple its development practices, of intervention similar association very current to across intervention. have clinical clinical FSGS. change clear in data supportive differentiation with are are compared highly improved are We and early eager potential to IgA begin very found treatment in and data between which nephropathy.

have As been put able a to result, forward. our a for together we strong package on regulators with path discussion

currently in regulatory successful have anticipation are activities discussions, proposed We for initiated In nephropathy, our protocol from regulatory final XXXX. feedback preparation expect of to around of we the process gain midyear finalizing trial and agencies parallel. in IgA

progress our in of the expectation we investigators the more programs on to XXXX. information look amongst are I've forward Our second nephropathy enthusiasm throughout CRO to participate program. study both of in IgA We and study half now our as beginning fosmetpantotenate year. been to our building has these with selected move providing of they the

a PKAN European We to In continue and treatment patients, additional living currently sites UK who therapy our our FORT. We fourth be US boost our families, to central the options. for PKAN pivotal areas enrolment in be to commenced recently are without quarter, and excited potential we first-in-class about efforts in first initiated fosmetpantotenate’s very effective sites. to furthered we key

small our to initiation number protocol read-out a time enrol enable of safely study pediatric calls to As data to many for know, of enrolment. short for of prior a them and of period follow monitoring you adult patients us board

PKAN this which of the adult cohort of enable sometime XX. enrolment quarter anticipate patients the have PKAN larger by patients quarter, enrolled enrolment the age end to year. expect given the that would We portion of open pediatric We second accelerating pediatric once component this of we do of in the under

helpful enrolment around patients fosmetpantotenate top As half enable studies such, we line of initiated in been complete to receive In have year-end, in to to potential in than expect four findings treatment which States. patients continue study, study years, parallel FORT their United the non-controlled to outside readout the of physician evolving three the continue knowledge our in PKAN. open, the data and receiving FORT fosmetpantotenate’s for XXXX. four more All would be second

patients. our will focus getting of ahead, be sites XX reaching and pediatric our fosmetpantotenate enrolment additional for adult goal study Looking and opened,

to therefore blood by offer increasing compared and to metabolic our around which the in of like or including can't mid-year well touch break leads CNSA-XXX enzymatic would the data I genetic, down It advance reduction enable a combined body of a CNSA-XXX intracellular respond fuel The to the we for BHX to to brain, to people defined current PKU sepiapterin, that is on phenylalanine experience. greater levels offer multiple should the brain these single where to CNSA-XXX PKU the in PKU the neurological enzyme. BHX. BHX, dose estimated that begin data excitement orally proof-of-concept currently that a induce about a impairment. more and population, due in phenylalanine to the a addressable our PKU a effective defective of in patients PKU. can quickly, have barrier, caused to decline the to bioavailable to studies, believe to to is is crosses lead opportunity to of and CNSA-XXX clearly and an endogenous an study patients There XXXX. large standard rare precursor make PKU condition ascending behavioral partners phenylalanine in phenylalanine generated These High with our population. benefit unmet early for greater not CNSA-XXX by hydroxylase missing treatment cognitive Finally, there difference phenylketonuria patients given is us a therapy. XX,XXX or patients. could PKU a with data are a Censa collaboration and distant regulatory treatment or future. pathway which potential need the the by us tetrahydrobiopterin current can pathway in can to converted potential proprietary suggests too X initiated conducting significant who is form date also of of CNSA-XXX is is natural of Preclinical have care. standard be expected with this Phase failed proportion care in patients liver That believe up

become We early expect XXXX. concept the study results of from the to in proof available

mentioned have earlier, positive CNSA-XXX exciting then As can XXXX. very if ahead pivotal in a this data outline, you advance development. will that and study are a we Based our see busy look in Steve we into candidates for to year product the on

X significant Phase focused four remaining rare We the study multiple unmet reaching milestones as including with expect to meet programs, these needs disease by development community. as possible on progress potential our quickly first-in-class key in to the

call update. the operational turn to me his let Neil Now for over Neil?

Neil McFarlane

strategies saying Thanks, life-changing living for of Bill. comments executing our to with terms Retrophin XXXX in a that delivering in advancing people start to like our therapies was introductory by rare reiterating leadership I Steve’s and tremendous would year in diseases.

commercial a strong We continue while all we our pipeline growth efficiently progressing posted with simultaneously growing From another our operate products. across current three portfolio. perspective, and to commercial quarter

$XX product Our of double-digit the the in XXth of million net sales growth. quarter consecutive quarter year-over-year marked fourth

quarter focused in multiple due to million. suboptimal fourth achieved therapy. guidance million which strategy steady million physicians initiate resulted fourth the pass stones to to as and for demand remained who or strong year, we and net to sales treat full continuing sources of of Our patients $XXX quarter the treatment. $XXX We our to saw identify data $XXX remain on in in continue XXXX surgery utilizing our patients Thiola require

or lead Another is dependent that output. raising to make optimal to cystine can dose of can education reduction individual’s Does cystine levels believe part We is by of each we a awareness strategy optimization. cystine difference stones. this a continue elimination on on

components that the our work more being to brand confident new, dedicated are the maintain the also XXXX. of on done patient on both I'm friendly team of Thiola with We will pleased deliver formation Thiola. growth of strategy our partners with our in

track we NDA filed to remain Importantly, on have XXXX. in an

we saw quarter. Cholbam, in the momentum Regarding fourth encouraging

therapeutic Comprehensive strategy spectrum bile acid be easily and identify these tools symptom-based patients. efforts in grow physicians acid results outcomes. people sponsored a the to genetic our timely and use for and of are continues Zellweger to living understand treating core both screening our and testing better uptick. disorders testing Our diagnostic in team’s efficient [intrepid] synthesis difference panel testing of methodologies for whether to with an focused making Cholbam, can contribute obtain meaningful and programs Cholbam appear The atypical manner, of remains way bile Cholbam’s a to use use to and more

to momentum, are we the stages to have recent these we seen tools early awareness some efforts still While with raise patients. in of identify

eager further our of So over we to strategy are the XXXX. course see in progress

increasing gained We from evolving continue awareness Chenodal new also and of initiate have importantly, see encouraged most therapy. our to we study patients CTX. Perhaps the we prevalent by knowledge remain the

Lastly I development. will touch on business

asset As option Censa. financial structure to is are milestones with an to additional Steve we committing of program upfront Bill very us and earlier, with the it derisk key This our acquire type the and capital. as attractive consideration about transaction allows mentioned reached and pleased human latest are before after materially

We be through that organization. now our assets Laura in commercial call clinical and value walk to the over to both financials. turn continue to active looking can for to the I Laura? add will

Laura Clague

XXXX. our and for tax year consisted in the program. year-over-year quarter, R&D basis, fourth quarter, million million full a associated compared compensation is $XX.X million higher adjusted million expenses the period the loss million to related R&D last of to due $X.X and XXXX same non-GAAP a note, adjustments growth On an when for compared due full to expense $XX.X to non-GAAP million Thanks, The full administrative $X.X year and million the for fourth were the related Neil. share $XX.X expenses, XXXX. fourth for full were benefit XXXX million GAAP adjusted period for and clinical SG&A for After $XX.X sales $XX.X to and the increase amortization. from and GAAP year headcount initiatives for legal SG&A $XX.X expenses same the price. and fourth development Selling, in loss full adjusting a from included and the higher $XX.X a the increase Cholbam expenses the force $X non-cash Relevant million of adjustment million for and quarter change the the a company's and full our of adjustments million, the were million XXXX. the Also an compared a for compensation quarter the incurred million million $XX.X million net and sales non-cash activities operational the primarily non-cash XXXX for year to expenses a related We resulting operating for the and On increase in last the the the were $XX.X for for a fourth due fourth to for of and expenses XXXX. were portfolio for quarter non-clinical year and $XX.X year quarter loss quarter Significant derivative expenses commercial $XX.X year adjustments Significant basis, and included full million reported support fourth XXXX income the year year, the respectively. income $X.X minimal liability primarily changes quarter a XXXX. of million marketing to for year Thiola. amortization. On year the we and product full quarter Net non-cash net fourth is fourth to million of XXXX The company's for stock-based minimal related expenses quarter non-GAAP full an $X.X general year-over-year and XXXX. change basis, reported $XXX.X $XX.X stock-based warrant for to for with $XXX.X the $X.X year net for million of settlement. to million of depreciation full the

securities. equivalents result use to from with promising our XX, We year. expected the our strong programs a December With for XXXX, of of during we sheet candidates. cash a to balance fund operations we clinic to enter XXXX, the expect in increase in marketable and million advance cash had net and four and $XXX.X do expenses cash in As XXXX product

XXXX, some collaboration, to of a anticipate which uses for now call upfront to Steve? related comments. back million Censa $XX $X I making for we cash the advancement. sparsentan’s payment in payment includes early sales will also milestone the and closing cumulative a We Steve million to Cholbam, non-operational anticipate over his and turn related

Steve Aselage

exciting for activity the work pipeline and time robust is pipeline This teammembers in a with into our on XXXX, Laura. the an and expertise advancing Retrophin. you, most in to the potential the leverage made and considerable history. Thanks business, progress shareholders. growth strengthened We we New very clinical our Thank Year a of exceptional for focused hard the our value of our for year creation that we so of to our our while further to both XXXX made deep commercial plan remaining patients moved

back questions. for we Let now turn call to line open to the Chris the over Chris?

Chris Cline

open can lines please. ahead Steve. go for Q&A up we and the Charles, you, Thank

Operator

[Operator Instructions] line line your Leerink Joseph, of from open. Your Joseph from question Schwartz is Partners. first comes the

Joseph Schwartz

will you the a of I was and with be like weeks the evaluated, and much, treatment, things dose duration description is eight proposed of design presumably if wondering trial general provide the all before, not of was in will of your terms in or on it the FSGS, used primary progress. endpoint very Phase for number Thanks when X us the patients, stroke it can broad that study? doses sparsentan congrats be as and

Bill Rote

is Hi, at that. Joe. will first a I Bill. crank This take

are We just detail some adjustments out the things get to that greater about. we finalized when will on lot that in asked protocol, the we final public of with and you a making be

that soon more weeks. the point a too to specific later be be eight is You we at clarify want that as we interim of did That as don't and have will analysis with protocol. than now is I what than short. are to study a final correct going going But is The be DUET. we the size larger to

Joseph Schwartz

model statistical of so we to proteinuria your data presented here? illustrating present can model [indiscernible], latest the between evaluate recently or relationship probability success and or to your you publish which will the Okay. the did how us you eGFR compare And and statistical it

Bill Rote

Certainly.

but internal it believe modeling that do that an discussion, I work ongoing published. think is will be eventually that I

What and how reduction our You looking modeled with without level changes histories analysis database ability asked a and longitudinal it an a And used to for in was at look over given eGFR little at model different we and by future those proteinuria. what and in about then change the at comparison was on that looked ASN; a as in the patients patient in individual was that. that the at able assess looking from at to is to than population. that and the [Neptune] time was treatment, presented others in predict agency we where data protocol both with the proteinuria

So there that treatment forward reliable endpoint, then in which if on the future in is be treatment assess saw in study could use That the agency in predictor the similar the doesn't the and A, difference us what a project slopes an gave on we a will the approved eGFR the this between Is confidence put at endpoint. controlled them pivotal would having then them allowing robustness of a we allow the eGFR saw in DUET, that a us a effect would have fail confirmatory. we interim, model strategy of they you to group. really to where risk great study the confirmatory changes, and go and of to

Joseph Schwartz

merely that I you guess presented the [size] did some it or so model – predictability or then you more the relationship then on And eGFR? did it strengthen Okay. with ASN buttress when around confirm actual the that data,

Bill Rote

we seen. it submitted We what a learnt already the had way that we we as that in it put was you confirmed with to got they the we and and had back happy constructed. November agency recall, similar think we opposed a detriment the in you one model, felt We when weren’t as in correspondence I together the get meaningful DUET, a multipart and clinically over like in relevant time. put together that proteinuria do to in revised was The it see single model. and reduction clinically in model it same with protection eGFR answer a the

Joseph Schwartz

for Thanks great. and again. congrats color the Okay,

Bill Rote

you. Sure. Thank

Operator

Tim of line is open? next from Tim your William Lugo Blair. from line Your comes question the

Tim Lugo

Thanks well. for congratulations progress taking question as the my and on

[patients], Kuvan, of proof is some with idea around to in study? they the you CNSA-XXX, give patients For included be experience some are could going with going POC or us concept, that or to are be this non-responders

Steve Aselage

will I some can Tim that give is it study. a be you Censa and question. doing This around that, color Steve. is good

It patients end you multiple It I to pull are a relative think the responsible at It doses. around the would trials of will Kuvan comparison be Kuvan. sepiapterin and the clinical design select for will an will assess year. We we effectiveness operating in the a the patients. if for they aware of non-responders. versus trigger for crossover Kuvan acquisition be not that that look until are direct on happens same rather the

Tim Lugo

is ascending And that single for – Interesting. that is dose study? proof concept, of the correct? for the This isn’t

Steve Aselage

completed, getting around end and data sometime next single or around The end study month Correct. ascending the We just dose dose have multiple is start year, The hope the the so. midyear, that see anticipate now. we ascending of POC started the sometime the year. the will just to from by of within results

Tim Lugo

to do And for nephropathy, you experience population, expecting the sparsentan could fantastic. go finding into work in IgA you the patient maybe that Phase with given Okay, X? molecule a dose are additional or and

Steve Aselage

than certainly safety and patients sufficient standpoint the for The Well, argument based is been experience adequate we on that doses. is that that from across hypertension we the XXX nephropathy the blood is are going a world, patients – experience primary given a in IgA those different the and XXX have intention the with population not dose working DUET titration make to of in that to drug our see that range pressure. is FSGS in

indeed the So study. argument where in value that dose our that I is but a see would gained case, We that perspective. struggle convince make be to ranging to still and regulators have is that there

Tim Lugo

we proof ongoing say Censa three well at looking QX program? Phase are the at it the this forward to company year, is to of the studies safe X potentially fast as And concept we of if as from

Steve Aselage

correct. absolutely is That

Tim Lugo

right. the Thanks Congratulations. for All questions.

Steve Aselage

Thank you.

Bill Rote

Tim. Thanks

Tim Lugo

Thank you.

Operator

your Do Markets. line open. Do Kim is comes question from of the next BMO from Capital Your line

Unidentified Analyst

question. also to adult for for know be Do. [Romans] the the studying [indiscernible] in wanted did there Hi, pediatric and population, expected after any as my the seen and this the that were [Romans] XX adult for [indiscernible] and go REO hurdle there up the taking additional to open the were going is population. are I [indiscernible] for Thanks

Steve Aselage

little anticipated. are Yes. with slower we several very There adults this Good than a of The got barriers don't with question. bit adult a population children, exist most is limited frankly which population of get patients This challenge that adulthood and not adult ability live in [indiscernible] adults. a is many disease get do them so and to for a to us. quickly has been

are the than be and trial we into on the more do yes done but feel of a And of in seem like and more we center We up adults [indiscernible] adult enrollment upper as to by bit and of should we the in thought up we patients end soon open the in for will the there from Europe coming patients patients get the feel it's and have will European adult we patient little the would additional like terms progress remainder of that. making slower that have running. the it have going we mapping older adult pediatrics today we QX QX as as aid

Unidentified Analyst

Okay. Thanks.

helped can it [indiscernible] of [indiscernible] dietary addresses on of and formation on of restriction. or you novel it if self provide the the address how detail more On it formulation the shortcoming

Steve Aselage

has back significant step follow gotten formulation on. what’s can it Yes, we funky that cracks particularly what we can old and take when four than they about more improved lot different to of empty than take sugar pills. [indiscernible] that [indiscernible] have It a have an coating they be and empty good say fashioned objective also and other that at that we the can an look kind stomach. specific and Patients smell on it sulphur then a aspects of take of improved a relatively be to and that stomach. They took kind about the of of haven't crack the appealing when kind

partners on job stomach a to on any great like looks be that right file improve this felt more be that make working working after a sugar have what who will like empty feel happen specific exactly could done should three we like our the of issues of So and in of we we four later formulation friendly have lot we day addressed we four the this [indiscernible] pills those more a the those which coating three step on formulation and patient times direction with we year. program would

Unidentified Analyst

Okay. Good quarter. to know. and Thanks good congrats on

Steve Aselage

Thank you.

Operator

question next JMP of Securities. Bayko line is Your the from Liisa comes line from Liisa open. your

Liisa Bayko

taking for questions. thanks Hi, the

Just a taking point end how think on confirmatory specifically. at you do look When the a pushed do EGFR far anticipate few sparsentan you the you that.

Steve Aselage

Well, that I a, be to design enrollment. dependent design that's trial trial on final going and final think and

difficult now. it's So say to right

Liisa Bayko

trying therapy mean from roughly. measuring because patient you be I multiple points you kind started changing, of when best by after looking just is that know I are two, mean to when three I going What how basis about will on patient you individual year that. one, that is be time understand the to I evaluate you year flow let’s are actually talked planning or after point looking evaluating that to in say this from an am

Steve Aselage

Okay.

the understand throughout think will a I I study be each It at little measured better. visit.

even the the longer data but the there of that is the regional it you along sub have of is have way. trial part And You part we delta the an It's unlikely at is you way are the multiple enough time looking length so down in for measurement submission the interim, point at along the confirmatory EGFR be to there read be of at the and will each spots of do have in that's submitted overall going at application. interim will that.

Liisa Bayko

time the in you -- you I I guess you be When to keep just which the that’s analysis Okay. do point over mean there the to trial is going or a see difference going when in do you EGFR anticipate [indiscernible] the and that you expect until start on be are to

Steve Aselage

just end Yes. study time the where [indiscernible]. specific is released there and No, will haven't we a

Liisa Bayko

due payment question. for Okay. just kind sparsentan Got that's actually my Thanks. final it. and And then when clarify you of that a you can mentioned

Laura Clague

Yes.

don't in We have that approximately expect a We specific. QX.

Liisa Bayko

much? How

Steve Aselage

X.X [indiscernible] of million is initiation payment registration milestone the trial. on the

Liisa Bayko

Thank you.

Steve Aselage

with looking your and we our will and we saying a just think to of specifics question bit get that's any we we the end you to question confirmation elaborating because written talk to and relative a aren’t programs have specifics at response been timing point maybe our from as on slip to prior to communication agency after acceptable book got Liisa about got that the about of the point interaction primary the asked little to We why agency lot and book back you until the hesitant too maths as previous and I about historically we that. briefing EGFR submitted EGFR exception we the confirmatory on in an reasons we going meeting. made an the one of know the confirm an briefing the got writing actually acceptable we

minutes share agency So that the after we on we we board sharing to with Other we are we with information you too. protocol the are details felt comfortable there have going we where that get on with now. written that the confirmation confirmation the were written

Liisa Bayko

helpful. Right. Thank you. That's really

Steve Aselage

Sure.

Operator

closing like at now for questions to would conference I Cline am showing the further this over no Mr. back to I turn time. remarks.

Chris Cline

today. We Thank look our and in coming progress you joining forward the call. everybody quarters. you on thank us you to updating Gerald our for concludes This

Operator

call. This concludes today's conference

disconnect. may You now

Travere Therapeutics (TVTX) 27 Feb 182017 Q4 Earnings call transcript