IRWD - Earnings call transcript Q1 2024 | Ironwood Pharmaceuticals, Inc.

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Operator

Thank you for standing by. My name is Kath, and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals First Quarter 2024 Investor Update Call.

[Operator Instructions] I would now like to turn the call over to Matt Roache, Director of Investor Relations. Please go ahead.

Matt Roache

Kath. you, Thank thanks XXXX and us our for Good update. for quarter investor first morning, joining

not under Our this include the of release Litigation to the of our risks to Today's for and a directly the press and issued of XXXX, Reform call A our obligation update found meaning the the may Such and end and website. superior only risk of as of undertake which substitute Act available press on presentation, or please and to a current measures. on actual GAAP our uncertainties comparable harbor on statements tables of accompanying well date statements Private that Risk slides annual the no results factors forward-looking Form our the we most XXXX. the heading the considered measures these as be within to Factors XX, these measures, applicable, statements. supplement as non-GAAP filings. to reconciliations extent in to, XX-K morning at discussion for statements Securities of financial in can are involve To the differ as Also year slide All be cause safe release should included measures. such SEC this materially. statement GAAP report is ended refer December speak subsequent forward-looking for statements

Officer, commercial review Sravan results Emany, guidance. will includes Mike our and During Executive Today's Chief begin financial Medical Shetzline, Financial today's Officer, overview; a our with Tom Chief will our discuss update call, brief Officer, slides. and Chief a McCourt, pipeline; webcast to provide our our

please for slide the So our of to website you section access of separately. accompanying in, go to Events dialing the those

that, I'll call turn over the Tom. to With

Thomas McCourt

us. for everyone, Good thanks joining Matt. Thanks, morning, and

to and pipeline; across this portfolio are here advancements so that priorities, pleased GI made significant year strategic cash to and care our X become LINZESS; company. maximize and GI with the are: sustained be profits deliver our leading mission always we've the our health We start like to flow. our which advance to far discuss I

its quarter increasing prescription with of XX% double-digit a XXXX, fifth year-over-year, by In momentum XX% the marking LINZESS prescription robust growth maintained consecutive the prior of strong the supported demand first quarter volume and versus new-to-brand growth. year, of new-to-brand

to related the LINZESS more for the based XX, of adjustment 'XX revenue later year an the you we of Sravan As have press a provide on outlook. this on result our 'XX seen AbbVie, which call. full year to to may release morning, as change impact provided a adjustment in gross-to-net onetime will in arrangement collaborative quarter December recorded on the by our estimate ended led this revised information detail first

in the Moving on programs bowel the the syndrome intestinal with adults of apraglutide apraglutide positive first approved. pipeline. treatment Most from progress These we weekly short the positive evaluating STARS made quarter. safety demonstrate with bowel syndrome only of are III for support, with therapy results patients and failure. who short GLP-X the if dependent potential Phase as topline parenteral a to company Phase our of III efficacy our the We notably, in trial, February in important results across with and have our believe development transformed we

apraglutide strengthen $X to abstract for we're and of achieve the billion probability uptake, apraglutide, reinforcing potential and sales. GI of oral has continued February, analyze of to selected tolerability in medical will broader the belief profile set robust these in data combination results a share new at Meeting. quality the confident that late-breaking submitted clinical data of and in data the factors III STARS Phase of for shared compliance we our upcoming We the Following an approval. was eager which as have once-weekly we drive on a topline These presentation late a the Digestive the scientific and with Disease apraglutide community. peak efficacy, high to has life net demonstrated patients, improvement Based X are and believe dosing, distinguishing that further

are area track a focused ensuring have on We path an success. we expertise forward commercialization, now of and a to successful record where significant

across label to focused support and who failure, swiftly dependent United with still file GLP-Xs. suffer soon Europe SBS expect there's commercial syndrome working adult significant a short patients approximately that launch with XX,XXX the possible estimate to are who portion bowl the in and States NDA untreated continue are by plan from on and We on of patients patients We intestinal as XXXX. with parenteral as adult these a a

infrastructure place have We in successfully. the investments commercial expect apraglutide only incremental launch needed already and to

approved, on a with with way the planning in established presence well commercialize are GI across to We equipped specialists believe offices sales our strong the the States. we launch and of if United already apraglutide, are

parenteral confident in bowel track are excited of who our market. are coupled for commercial trial the results record We effective STARS We're drive meaningful syndrome impactful execution outcomes leverage patients our for with to the support. dependent and the the to with position proven maximize apraglutide expertise on from positive short potential us uniquely

future for continues which until Ironwood reasons: continue wrap LINZESS in poised we expect the robust First, deliver XXXX. flows are and to to up, growth following for generic entry meaningful driving to is we demand cash for So growth

reinforce in Second, profit have long-term potential. revenue we transformed and and probability trial high conviction positive company approval with of believe growth Phase from results our we apraglutide's III which STARS a the our

the of to potential year. that, apraglutide has this to for over topline believe more Phase Mike a to excited hand the CMP-XXX discuss pipeline see We in later and results CMP-XXX I'll the therapy Mike? we're primary II With from cholangitis. Finally, disease-modifying biliary be to our it detail. treatment

Michael Shetzline

short with the the ever we pipeline across largest progress GLP-X dependent apraglutide on short study in patients the global proud countries. with We're data across trial parenteral support. XX for pivotal with pleased of in III is from the failure, bowel our syndrome positive in and bowel begin results and good made intestinal programs robust Tom, Phase We're very the Thanks, a I'll quarter. morning, everyone. sites generating XX set syndrome which STARS first

treatment treatment An which important in aspect rate, of design of study for was STARS this generated the to support optimization Phase low patient a in prior rigorous population. a That the apraglutide volumes III resulted placebo parenteral robust from effect intern treatment. placebo stoma driven GLP-X Apraglutide sport actual populations. and at a relative by weekly is once-weekly in volume parenteral XX with effect to colon-in-continuity to meet both the primary only change relative Xx endpoint baseline of its week

and apraglutide's potential clinician patient to need a thrilled As a I'm of new options. treatment about benefit once-weekly community administration myself, profile, convenience of in the including its strong

placebo. abdominal in patient and onward weaning throughout or in treatment in distension, Summarized the demonstrated a primary X patients reported populations with and on rapid injection weeks. excited reactions by in onset and study. Slide observed week enteral endpoint at at by both X, also parenteral The site stoma of of colon-in-continuity colon-in-continuity of fact that complete reached efficacy low are the which effect prevalence line the With support we're and of the the both off XX some autonomy stoma further analysis populations I'm and excited the data,

including clinical of DDW very and profile, upcoming dosing Overall, looking belief demonstrated meeting the of apraglutide's tolerability and who support. probability which support short once-weekly standard its high forward of potential to in believe profile differentiated efficacy convenience patients approval data, parenteral bowel to we the enhances of further We're care syndrome the and and for our who improve much are we apraglutide. believe dependent and on presenting supports apraglutide's

year. the ever syndrome data the with plan GLP-X study continuing to findings We at failure, to from additional forward disclose also intestinal largest bowel in set look later to meetings further and evaluate robust short this

tolerability trial results addition in bowel graft once-weekly from to tolerated acceptable Phase apraglutide III with the day of we also gastrointestinal the from patients The steroid-refractory in objective. primary showed disease. results profile, primary the evaluate apraglutide steroid-refractory short standard safety of patients up an acute to and XX GVHD safety our treated well GVHD the In was trial STARGAZE to intestinal in failure, study's objective apraglutide with in versus apraglutide announced with of exploratory of positive Results with acute care. syndrome was host acute that positive

be GI will the its addition for In majority via will The secondary endpoints safety, congress. by XX responders assessed patients day tolerability encouraged of on and data X-year by The at data response to lower additional lower day efficacy study We're of and expect to treatment and organ through maintenance and all safety day continue evaluating safety, XX when day maintained response through at all a GI XX, endpoint future apraglutide medical present responses. to XX and responded STARGAZE efficacy. XX. their and evaluated

CNP-XXX believe no T year. on root II CNP XX. of PBC CNP-XXX. T patients signal to patients address to further results evaluate data in quarter, pharmacodynamics for is tolerability, responses CNP-XXX immune XXX the to in data liver The PDC-EX safety, destruction study Top liver to quarter, II CNP-XXX for therapies for on turn third cell be results completed third program a The saw clinical first the could the benefit. We evaluating efficacy T disease-modifying favorable COUR that, which with early for be bile targeting topline as with T leading it looking the strong cell-driven the and several patient Moving on PBC that are the Slide the has of and of in report the will suffering cell The and/or With are function there the patient patients first and indicator topline day specific response, of markers year, unresponsive specific responsible support believe markers will on PBC patients in I'll in T the track cell study we focused addition UDCA study for PBC. Sravan. anticipated treatment. demonstrated the who results cell-driven response Phase of Ocaliva. of market we CNP-XXX placebo-controlled in the CNP-XXX. the In the of function, proof-of-concept study positive enrollment a potential to a therapy XX over the through showing on underpinning potential on based also liver quarter to In of with we're the this the cause is PDC-EX with ducts. today Last treated Phase antigen are prime is pathology immunology of

Sravan Emany

Thanks, everyone. on Mike, begin XX. morning, I'll and Slide good

demand in carried LINZESS. on the see, of and prescriptions increased year year-over-year you LINZESS XXth earlier, XX% mentioned the demand XXXX, continue that with the now rose reinforcing remains is compared first remarkably quarter, the momentum first Tom strong. can market quarter This the positive LINZESS. professionals while to volume as quarter. choose LINZESS into new-to-brand As for first XX% And patients healthcare prescription

We utility combined with guideline believe a as satisfaction demand and the recommendations, of healthcare with and strong execution access, and both professionals, syndication, the success LINZESS of new patients class-leading treatment commercial high will patient formulary momentum start continue result increased pediatric focused from acceleration.

representing to AbbVie, moment provide a net the of LINZESS the take on adjustment subsequent an and increase to AbbVie's first an $XX In gross net U.S. quarter $XXX made difference on X% LINZESS in details XX. actual sales to to U.S. net change like of reflected the XXXX by reported quarter, gross a estimates AbbVie was subsequently information to payments of first estimate made. in on provided year-over-year. XXXX Ironwood million, sales, million Based the net additional Slide estimates that I'd between

estimate, year-over-year. Ironwood approximately of revenue. recorded million in down As this XX% adjustment, million, Ironwood revenue a reduction in first collaborative this $XX quarter a result total to the change arrangements $XX With was

quarter quarter financial reported of to quarter commercial $XXX estimate, Slide first to change of QX XXXX. -- performance U.S. gross XX% million, X% the on LINZESS' excluding compared in in net performance first on margin, AbbVie, LINZESS the our by XXXX as an sales, slide to of was in first net XX% the were year-over-year. Turning XX. increase

in As driven ago, in by primarily recorded the U.S. Revenues I year-over-year moments change were noted million. collaborative revenue. $XX $XX to a arrangements Ironwood revenue lower LINZESS estimate primarily few collaboration due was million revenue million, $XX QX of to

facility balance million in in and As $XX In quarter, generated cash. from in repaying million, credit $X million. revolving quarter operations, with the a adjusted loss After net Ironwood $XX EBITDA cash $XXX principal result, $XX flow million was and the of outstanding ended first on our cash was million approximately equivalents. GAAP the cash and

As on of continue capacity. the end a notes convertible June expect balance In term, XXXX drawn we settle cash mature to undrawn of that on the and on to the hand $XXX the outstanding of our March, near through was revolver combination XX, revolver million.

Regarding capital allocation.

We operations, the and generation support our incremental for fortunate access potential with a and the meaningful cash ongoing further markets we fund not to to are believe LINZESS, all progress the in anticipate launch capital be sufficient funding need development will position we apraglutide flow which programs. for to do

I'll Next, on updated review our guidance XX. XXXX Slide

million. $XXX a of quarter, U.S. adjusted mid-single decline in and to of and now revenue LINZESS' million, of we expect EBITDA digits As for estimate percent. gross XXXX, LINZESS Ironwood result net greater first full change between in year in net $XXX million sales the $XXX than the

additional the first We from apraglutide at apraglutide. the Digestive look its of sharing this we STARS believe in further Phase month, enhance up, to advancements clinical Disease later quarter. To we profile significant which wrap forward III across Week study our will detail portfolio made

With data we STARS the on way our our LINZESS. readout, our positive portfolio extending beyond to and we horizon are growth diversifying well believe

on are profits cash on assets, other executing growth dependent with get priorities by quickly and robust support parenteral as who pipeline focused apraglutide Looking and soon as our to advancing to moving are and strategic demand driving sustained ahead, flow. patients approved possible SBS our LINZESS and delivering GI across we

GI shared diseases. advocates of to may supporting to patients, line now and questions. for all the want for employees, for you close I therapies their up caregivers thanking Operator, by advancing our and open dedication

Operator

question Amsellem with Your the comes Instructions] Sandler. Piper first of from [Operator line David

David Amsellem

their So say just just separation? at a data about both color across within here. is couple what time I is know you statistical separation I weeks. I'm what and the guess got stoma know but or getting wanted the get I some And of questions had what But patients. weeks the I you've at is weeks, you at colon-in-continuity statistical additional XX coming earlier points, to XX on efficacy DDW. say, shown subgroup, CIC XX at mean

anyway. fine, us can't it, the that. So if answer you just I question I'd And ask understand thought but help that's

to And leave about then secondly, to you're have see XXX, on how bar advancement. forward? I'll in it order what there. thinking continued do understand us the you Help move for

Michael Shetzline

David.

It's the about CIC endpoint around apraglutide. And primary So remember both a and has just that lot discussed to critical we're colon-in-continuity very stoma included the excited from data been versus stoma. patients.

for have clearly the patients where from So on whole regulatory based didn't colon-in-continuity GATTEX the and with contribution distinct precedent that quite we set, patients. that a think meaningful colon-in-continuity to happened fact we endpoint. see a was high probability population, for the contributed the approval what really That the of CMC they stoma primary

at you'll And that is now DDW believe and And to So once-weekly high that's and more Phase going us for the the to we certainly colon-in-continuity continue is with well of efficacy given confidence the rollout and which stoma see of therapy. specific probability the certainly the for do a colon-in-continuity colon-in-continuity submission patients. what data approval for III further the in opportunity fully that potency have support patients. in established we're asset us we this in gives a of whole the data population success even

placebo. and numbers and in details most GLP-X data safe in tolerability which really profile. terms will a fair We've safety which the line you'll and will pivotal from with of principle, in events of addition, in see And differentiation the learned a amount at class. And a lot In were well-tolerated really support data therapies on actually there from all the trial tolerability. DDW, support of apraglutide be other events the further very

very So we good think for it's a profile commercial success.

what And behind on and modulates the see what the cells. you CNP, -- with the if science PBC. strength hope destroy as in PDC-EX-driven the determine asked What next T we immunology test question was we can T the the PDC-EX we okay? ducts And the plan reprogram with pathology program CMC to cells It's discussed know CNP-XXX of is the we we CNP real or a those to treatment that disease. bile of about

effect in for no look assessment function why we to longer demonstrated that cell ducts. liver the that's this with So potential And shows us the opportunity have T meaningful that, we're to a that XXX-day prone trial the a liver that bile function we're T opportunity cells pathologic, longer no combination really number to of and assessment. a improve response for cell destroying those are that looking well. outcome, T And looking assessments clinical as demonstrated in at give and

Operator

comes Craig-Hallum. Your line the question with from Knickerbocker of next Chase

Chase Knickerbocker

on Or break just payer kind of from to not what in digging bit by million as exactly Maybe around for was as the just us last more gross-to-net a a that to year. best little AbbVie? what was was it's Can specifically $XX adjustment talk about detail bit channel? far accounted adjustment by just however you you that just that little that think probably down

Sravan Emany

Yes.

on you channel of this this all, fluctuations taking -- gross-to-net relating your would shift are I'd I a thank to for first in something material. us, for mix So you isn't occurrence industry, common know. zooming question. say out say normal Chase, It's within their periodic as and that first, in I'll basis that the happens really

during the it to in difference they and And with change rebates. associated was subsequent between their contractual government I And gross-to-net invoices that think it based for the got. was information on primarily and the the actual reporting. was the us estimate AbbVie provided year

of terms where can I color give were. think we in the you that's probably

Chase Knickerbocker

is next on maybe APRA NDA? the Certainly Type looking Can had to you soon? scheduled been in you around one talk submission. or your That's kind the of forward filing. data, And meeting kind helpful. steps doing the for specifically left the a data Have talk that to just of the work just what's be with Maybe prepare done about that then B you've Mike. for the to all with little background

Michael Shetzline

And our Yes, key that's clearly, sure. good That's question. priority.

Our #X, the X APRA X and priorities is submission.

So on the oral to continue acceptance. that. deck resulted it's at the data. in clearly what as hands abstract for That's DDW look We all

we're and in So the support, out. about all that. also to parcel the is do and we're with the to aligns That's everything track. But data to going and get submission submission excited on obviously, that data very part getting to trying

currently the we'll to moving in really meeting, the planning submission we're We're as make not submission well. potential we're a which So as get as looking that more granular on pre-NDA we'll we And available. XXXX. still forward expeditiously timelines, do forward And possible. that as targeting launch certainly

Chase Knickerbocker

just for CNP-XXX. Okay. last And then me on

to liver will XQ, be confirm that Is for and get cell in both when investors, that be function T also Just will data that right, Mike? that to response, see data. able we we

Michael Shetzline

Yes. cell We about demonstrated T -- to T the talk plan the cell effects.

point the specific PDC-EX the prove the around the and program, reprogramming obviously, antigens. of immunology which the So is

as as as So Remember, study. CNP-XXX, early it's It's so a the a sort Phase well. we liver in-human that and plan that to frame. outcomes first for XXX-day function a time share study. well is of II study It's

clinical to year. opportunity and we things we But function those and like endpoint the those we the know assessments. liver real see obeticholic and technology have early did may deal, an the why You CymaBay that and to based in science that on a went clearly think a products acid out

Chase Knickerbocker

And to just Great. you. Sravan, I'll come then last back

expectations that the only the same as mean, really cap million your changes this rebate say changes your it, expectations Is far to far as in the the was goes to everything $XX guys' is as on adjustment. Medicaid this XXXX your I else revenue year, certainly LINZESS. material guidance. fair at on it on expectation seems Just looking as from

Sravan Emany

Yes.

that say our would the reflective of now I is So guidance adjustment. onetime

to of single-digit demand that headwinds would -- would erosion price As continues performance reporting to or having been that we're double-digit of pricing onetime brand the out-of-period single-digit you based I the growth, anticipated we think had the AbbVie's and strong our relative kind can the faced low see, of revenue on have be with really adjustment. we high there growth, outside have a we

Thomas McCourt

And think is, I would comment I the of is we're growth we is But can X piece nurture. do of on this to obviously to really know think access, demand Certainly, continue we there's other with things question. you driving the which the XX which kind year the the marketing mix. that. brand, to treatment of as kind only high see, part seeing regard that in is for want is the XX, remarkable make what no really payer what are that year satisfaction, other I

the be to that really will doing we we to value continue marketing partner with working what LINZESS is really our mix moving that forward, Now so evolve can can create. optimize

been have of as day investment we mix, marketing and doing reduced the X brand. we've the the profit this evolved So increase we've from the

move we investment on the I want growth line. what forward, and we mix to really As to focus demand continue what think very the to and we're right bottom profits marketing in appropriate durable drive is to now seeing brand is

Operator

comes Your of Li Jefferies. the next from question Amy with line

Amy Li

apraglutide, updates [indiscernible] APRA your on data many on these And in place current any do patients estimate late of to give treatment? addressable differentiation at for the how you you're how post your market the you sales being On thinking current about And last ICD-XX with is can support we have put access us any Additionally, codes on get of potential to year? will force? this durability DDW internal what

Sravan Emany

why one? answer with I'll the don't one. Mike, you start second first the

Michael Shetzline

thanks, Amy. So

and administration of clearly, once-weekly dosing. data lend of in term. more Phase and really to the as pharmacokinetics I So you I durability, weekly available think pharmacodynamics once-weekly mean terms that supports only certainly III sort itself the mean, suspect the therapy, that we longer

a therapy. in So regard. once-weekly that itself the data speaks It's for

bowel parenteral obviously, enteral need maintain from therapy Then ideal think term, most often forward, patients it to to right, be that I that support. position come going they intestinal In terms that will they where growth. longer off actual setting, all a But to continued is and bowel them, a they other up that would for revert we've back of as they're when the need parenteral plays patients is caretaker GLP-X in for GLP-X have who to goal autonomy, how understand it, could off in out. limited with epithelium, often continued come the therapies, from support. reality used seen you therapy GLP-X the from long-term benefit with to short because

Sravan Emany

then our And overall the the a and our force, ICD-XX level just perspective. again, the question practices step We've is on the about XX back access calling our to taking clinicians. from of codes United unparalleled across sales on got States major sales over probably and GI reps practices leading these

Specifically we're this Amy really excited honestly, development, with about Li. codes, the ICD-XX

is thing big the codes to are. shed real actually ICD-XX starting are patients these many think are light I how on for us that

heard the things I differences are. in little of hosted think some yourself a you've what you've about on bit estimates the

estimates placebo. apraglutide populations. a you'll the the States, then capture to identified think once-weekly profile across equivalent and date product of data the our data in more an It ability real months. with presence to comes And a efficacy our the so patients CIC to through as across now, and light United both having overall our patient being how safety X,XXX with demonstrated weeks, share ICD-XX reinforces as few see -- I in best-in-class administration, with stoma tolerability been just about our there patients there many are. And codes think that have have or I already few as our just been to

feel and is dollar I I a think, ability penetrate -- about be We think billion share to our capture confident insight. that brand is to that it.

Operator

next Butler question comes Jason Your with from JMP. line Citizens the of

Jason Butler

awareness work about growth year you forward market to can on And then doing for APRA. XXXX. you're beyond going brand talk work drug? contribution presentation to speak maybe What this for do the obviously the you maybe to pediatric you're the just is build this quarter one data? First the secondly, and Can the into just looking pre-commercial of to to prepare of of and the LINZESS, market

Sravan Emany

Yes.

you don't why part handle I'll Tom, and first take one works. that So question, the the maybe of then if the second

Thomas McCourt

the question I first mean, me, remind was...

Sravan Emany

the brand awareness, The activity.

Thomas McCourt

Sure.

in targeted patients launching for digital as we options. and platform program patients primarily prelaunch on seek midst activities, GI as So and far the the probably disease a stretch are of to the community will education for which just better into understanding a

the as trials we're and And getting this of the through from clinical here better these they're how people, to the a really as who therapy. far within performance in academic feedback really care. working the in educating far impact all practices how patients the in need of by that them help apraglutide on the identifying the but very, through forward get for is and key this been and far very response is overall as do are, a with to collaborative we about the way, is center the encouraged patients as well of as the as work excellence as GI opinion not just these leaders looking very available that rate We've also objective acceptance effective to exercise, process patients So increasing disease more excellence. debilitating as big of large the awareness centers

prepare in strategy. think well program. that you course, go-to-market -- we're to our of has question? work take to been we're So disease LINZESS the and ongoing, I positioned implementing awareness of the the Do very early we're want And just stages

Sravan Emany

that. do happy I'll Yes,

strong started, think in and We're to about has really I still growth. think the your new-to-brand volume the think progress, early since we so overall, indication. date, encouraged prescription we're the by pediatric its I Jason, launch, launch positive about question So on I frankly. are But the I clearly, think, really pediatric launch we're

specifically that a basis the new-to-brand group. think in XX-year-old approved that XX% call for is I which earlier dose to mentioned XX-microgram growth growth dose, Tom is portion year-over-year the patient on X- on that the the a of large

what's those embedded in of it's it's here for in think as sustaining LINZESS our part long-term growth numbers. So I And we're year XX.

Operator

next Your line Bansal with Wells of Fargo. the from Mohit comes question

Mohit Bansal

couple I a of have questions.

you happens in this mix I you But your the all. versus had subsequently and for the a the XXXX mix, So because bit asking thanks mix it our because expecting you ask know than particular updated on again, more like are $XX million. to and government guidance one clarification. until for Mike, the modeling which impact for mix thing is you change little typically, get that commercial wanted because math, that the, that you one similar -- was don't Are receipts by well? a as I'm

the question. that's So first

And CNP-XXX. on is with ALP the second question

X, more ALP was by there So Seladelpar, impact. if drugs it month I like incremental like was an impact on an X stabilized, not after at it was look then month that, at and

So enough appreciate mechanisms see isn't benefit? I to the different. are XXX-day

should we there. on think benefit So endpoints about like how ALP

Sravan Emany

you Mike, I'll the don't then first why guidance answer and go question.

Michael Shetzline

Yes. through the question as acid like good know, Thanks. a precedent what and is It's around how got clearly regulatory approved obeticholic phos right gone that's CymaBay's you alk because, now.

it So approval, clearly accelerated not approval. full approved which for path is is an

sort help the ways may liver. effect Alk a the of liver nonspecific You lot pruritus bile balance really how because on CymaBay's moving of phos in that of sort it is a to that know very function speaks actually added in need. is through to

flow. mimetic, like a important if it acid, obeticholic very understand actually is which bile to bio it's something give increases So acid you that

not meet at had have in One a show you'll did which incidentally aligning And also with necessarily that commitment liver is to why function improvement. with get It's alk benefit phos. not the early needs parcel that's and the post-marketing that's histology broadly a obeticholic of function benefits improved time. part from more to liver acid that

completely of targeting important cell-driven duct what to is phos bile you T is which So the And mechanism as highlighted, is understand is the actually different. destruction. our cause for. there alk We're PBC, root it

to to of clearly of longer therapy. attack the this T cells it reprogram affect we And PDC-EX specificity then cells the T to no demonstrate T point, from going clinical but XXX-day a liver certainly we see those why bile your that's we improvement. can early that this going think the meaning have we'll combination see that function look, to improvement, so and the So a of response why have believe That's we're we cell learn. and we're for opportunity they then we an have clinical learn the that. And need, line given clearly the We and ducts, specificity to time improvement.

that different very important just flow liver the very to a So approach, disease. important for the for through realize disease-modifying liver we're to going certainly, a is is not bile potential And benefit for it's moving understand. mechanism biomarker which actually also, better,

Sravan Emany

in guidance One, -- our perspective, your on and accounts our on XXXX I'd from we think anticipate XXXX, guidance level, we the it's question, XXXX I or it's So for again. say gave Look, guidance. the think high mix I

been to has directions think to I is predominantly a we've guidance expecting decline, pretty as negative as that, to expect a this deliver We've is I line before, single-digit that's estimates still would in guidance. good adjustment. years. brand by have or growth, the adjustment. we're the positive on good over point, think I full We the with is our of a overall been see predicting LINZESS over with in a This based years it for prescription as and in anticipating demand the always I pretty decline true, net last channel. what is in been been with driven respect And several fluid annual Outside move can at that Channel mix about the onetime high and mid-single-digit onetime year. a said mix stated, think we out-of-period still sales a pretty and but as our and

Operator

One. line with Tim the of comes Your Capital from next Chiang question

Timothy Chiang

Mike, plan just you significance that earlier secondary data need endpoints the guys STARS on. from with especially the guess, endpoints I I from do the patient didn't secondary DDW, at the the statistical CIC on week you population at was looking study, showing, back

Michael Shetzline

patient specifically populations. Yes, further if at of both like is in to CIC referring you're or versus XX weeks at things we certainly conviction the Tim, secondaries might yes. And of sort that things data answers key enteral think XX, autonomy our see the supports stoma and good efficacy you

support on heavy. presentation. a development, plan as change from that -- lot that done sort it DDW in relative to planned have in data volume very and well. see The that baseline but of and in to It's we capacity the oral still yes, So the obviously have as at it's have already, decrease well as DDW parenteral we

by is impressed our patients. in very works clearly be you'll with because stoma think that data. the excited both it of I supports amount conviction drug and the approvable it clearly We're very certainly and colon-in-continuity

to really are sharing forward community. looking the we So that broadly more with

Timothy Chiang

on just rate Can follow-up. XX%. you on in one your noticed studies? comment that? these Mike, Because effect was third secondary Why almost placebo I is the the high placebo endpoint, so

Michael Shetzline

for study's mean Yes. XX.X%, the to and realize key the think the I primary response placebo that is statistically was And approval. right? that's driver key endpoint the to path positivity the there I

key a that's keep think I of. So to thing aware

change it's XX you be baseline The secondary, at on it's the a here, from in response we're been third trial, GLP-X in design then tendency other during algorithm. instituted the to off, is And to that XX-week placebo there the new this thing to we change And actually had what alluded tested clinical key weeks realize a to, different never which X also talking which a therapy primary realize is meaning day a the And relative addition, the winning response in for endpoint, that's can before. is about endpoints is trial. placebo versus important the XX%.

you that, one out. threshold study. for what to be with figure you in still it both out the people output sure real the may potential fall the place could response made an algorithm, that's would year thing as that's into to Because of early volume-driven, wean, data the XX% clearly under study. drug-treated a but looking the So exposed and going that's the that We're for make weaning on whereas if there list though clearly make APRA population, be the high. played elevate study, and which still third was forward to more numerically And the CIC point endpoint, on time the it. to carefully it the realize understand then But see We're the cost points to opportunity response final at patients placebo endpoint XX-week later in response winning one key might placebo so was placebo the high is through even in analyze we we'll superior.

both looking than get when in worse at APRA that a still case. placebo this approvability, the numerically the and for success And the talked fact that then secondary like of for not primary whole we did positive given well a positive sort to the be not being of think key approval that first So things the of about bodes That's or in high aspect that. things clearly probability better we're population, it populations. for we we like terms will of on

Timothy Chiang

that would you one them the maybe And patient in get especially just Because the be Mike. you Are follow-up, items, think last label? think those could colon-in-continuity these some population. I of do important, on

Michael Shetzline

Yes.

think get everything works think in very going the label we're to work to I certainly patient the can. drug we well in populations. We both

the of exactly for One we those reasons additional that was included reason. secondaries

as is However, statistical that didn't higher are now, because they meet challenge I better. obviously, both significance. But numerically mentioned,

So strong for approvability. have a we confidence certainly

Operator

for you today's and Thank gentlemen, Ladies that call. session all joining. and our Q&A concludes

now You disconnect. may

Ironwood Pharmaceuticals (IRWD) 9 May 242024 Q1 Earnings call transcript