IRWD - Earnings call 4 2023 | Ironwood Pharmaceuticals, Inc.

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Operator

Good day, and welcome to the Ironwood Pharmaceuticals Fourth Quarter and Full Year 2023 Investor Update Call. [Operator Instructions] And finally, I would like to advise all participants that this call is being recorded. Thank you.

I'd now like to welcome Matt Roache, Director of Investor Relations to begin the conference. Matt, over to you.

Matt Roache

Gavin. you, Thank thanks and and us our for Good year for XXXX quarter full investor fourth morning, joining update.

statements. accompanying Our available safe press our include and and on A may differ is cause of be can involve actual forward-looking uncertainties harbor slides results that release issued factors website. these current this Today's statements on morning risk Such the risks statements materially. annual heading slide and Form our to report at found discussion well in Form call subsequent and our under quarters Factors statement XXXX, ended our XXXX, June XX, the ended on on the for XX, Risk SEC year as report the XX-Q filings. XX-K for XXXX, September XX, in as and December quarterly

or speak only these measures. the of end to financial for directly at All to press for release a no Also as we undertake a GAAP our such to date tables considered extent of to the non-GAAP and included measures. reconciliations To applicable, our of be presentation, as refer comparable the obligation most should this the of update statements. substitute supplement not superior measures please which forward-looking to measures, statements GAAP the

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

the to in, With slide access Tom. section those the our you that, call website Events to separately. dialing for to accompanying go over of So I'll turn please the of

Thomas McCourt

delighted our Ironwood are: realizing LINZESS, the becoming sustained today. with and cash industry. joining is us significant we toward I team to pipeline our believe bright. which the the XXXX made deliver we in we GI made and our flows. Good thanks headway progress of future our am in across vision leading in very maximize morning, proud progress XXXX care the I'm advance everyone, company and priorities, XXXX Thanks, in and made share GI profits We important health and Matt. the strategic X why you for absolutely of

As to in to company. our look be what XXXX, attention we for turn strategy year an our and confident expect and our I'm we transformational forward exciting to

Let's brief overview on begin of of with on First, adults XXXX. strategic our in terrific another In market, LINZESS. year increased demand and as had its maximizing prescription Slide idiopathic XX% a achievements the a leading prescription IBS-C treatment XXXX, key LINZESS year-over-year. our priorities some XXth year In for robust X against And constipation. the chronic with

XX% to potential. future prescriptions XXXX, compared up indicator New-to-brand ramped significantly, believe key growth which for a is increasing we

the all-time high market reached in constipation share LINZESS market In XX% an branded addition, in its strengthening and and of combined generic IBS-C TRx idiopathic chronic leadership.

incredibly proud FDA prescription And and for ages an this achievement XX, therapy of. in patients LINZESS pediatric first functional for patient in we're constipation of the becoming XXXX, June to only the received X population, approved approval

demand strong forward, on remains and delivering LINZESS brand Moving grow our focus subscription to continuing profits flow. cash and

including we dosing. If syndrome parenteral care bowel achieve approved, sales. on of the with standard in Next, successful, and can Last in the support potential our the analog, need. has asset, unmet as Apraglutide patients strengthened areas convenient GI we next-generation, clinical advance profile pipeline its we GLP-X of pipeline of $X believe treating net dependent once-weekly long-acting GI become the our year, acquisition if potential in with Apraglutide VectivBio, based believe billion short its to high the lead on Apraglutide, peak

study us confidence which properties the will data Nutrition Phase III positive including pharmacologic from out track study the date, the to STARS on and in strong unique let to gives read Apraglutide's STARS clinical March. data in

life We suffering in positively standard with treatment CNP-XXX early key excited third treated these II T-cell biliary completed Apraglutide Apraglutide, in rationale evidence looking disease-modifying data could to serious from improve in the addition the with quality that GI impact the believe top CNP-XXX, this progression of data disease progress last of the and CNP-XXX of therapy forward patients year, and PBC. the to the for the have analysis a potential we responses In the we about showed mechanistic cholangitis We're line potential we're an Phase for asset, both or favorable of primary of which to also patients PBC. Late diseases expected supporting year. for quarter. care believe

Our to thoughtful vision flow. and is allocation disciplined the we to We're and sustained value business, third our being and strive capital our cash to committed deliver to achieve in grow priority patients as shareholders. profits and deliver

performance for medical you employees, advocates to and all programs dedication expect deliver in the greater adjusted progress We celebrating of programs, significant XXXX, for for create long-term disease will patients, leader data combined growth take to to success growth. to the end to caregivers for diseases to strong which clinical million thank to this opportunity believe to we to community day. disease At we advancing and catalysts, and Ironwood's supporting the positive across we special EBITDA, new with momentum ahead in key our patients therapies the rare present believe to years potential the continued with their near-term say the the value the I'd mission We're to shareholders of the Looking multiple LINZESS be unmet rare GI. than shared need. this the will a with for us while month, and continuing like pipeline uniquely positions deliver opportunity be of excited $XXX in come. about propel

would like to pipeline. turn review I call over to to now Mike? our Mike the

Michael Shetzline

and everyone. Thanks, morning, good Tom,

transformational and GLP-X upcoming clinical acquisition. portfolio disease program in as the intestinal failure, company, have a Slide We VectivBio from development shown innovative which successful Phase approved [ considerable Over also is the our with we in top March, potential with significant III unmet few to syndrome for expect as we footprint support be analog SBSIF if need. once-weekly GI syndrome short X. which our and dependent only primary of focus for the our a believe past of Apraglutide, driver patients on the value best-in-class Apraglutide strides spectrum there bowel line data programs made the years, on could that In bowl of was parenteral as for known Today, we've short expand has with STARS the ], whole of GI. data

is efficacy both and across [ subtypes, show stone STARS X and colon trial designed patient novel ] to The continuity.

XX We As to primary parenteral achieving the view endpoint is pivotal as you relative look endpoint from SBSIF success data seeing weeks. may primary the and recall, as change weekly for only in forward volume the March. at once-weekly the therapy score in GLP-X baseline

Apraglutide in for addition this on to GvHD. from the the with is a short which program. at In patients potential graft-versus-host inform this asset also will later a syndrome disease quarter, bowel with evaluating or decision for investment II treatment Phase intestinal as further we're failure, study looking Data exploratory expected

favorable in the saw third the year the expected Next, T-cell this CNP-XXX we encouraged look line of in last by and to with CNP-XXX liver top results PBC. forward We're how quarter may that patients responses function for XXXX. treated seeing in impact

the because about PBC. it potential therapy excited CNP-XXX the be patients for We're to suffering disease-modifying has first with

wholly life front we us and IW-XXXX there we tremendous today with to ducts. near-term believe a are The the multiple in syndrome. to of of programs market therapies With the care catalysts The for And pain Sravan. improve in that, is the bio and finally, turn GI the well. quality and I no cause pain diseases. reinforce As the bladder of confidence the of the root have cystitis on patients Phase visceral conditions, it for asset just owned study ongoing interstitial highlighted liver with address II have I'll our that destruction suffering over including standard potential the progressing autoimmune opportunity Ironwood of that

Sravan Emany

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

earlier, mentioned another As had strong very XXXX. year Tom LINZESS in

and satisfaction new pediatric as market. the in both you utility demand patients has of recommendations, see, syndication, and continue over access, strong momentum demand will that to been As health with care choose a and can start growing the LINZESS high treatment focused patients patient health care reinforcing believe from class-leading and time, continue guideline increased clinical of LINZESS a We new result formulary execution success with growth remarkable professionals, professionals combined commercial acceleration.

ordinary shares we At a share Ironwood provide VectivBio business operations brief VectivBio integration In VectivBio in $XX ongoing I'll for time, well. very squeeze-out update merger cash. the successfully Next, remaining progressing under transaction. of purchase all completed outstanding the that The law. is and and Ironwood December, per Swiss of on

sales compared prescription offset inventory fourth by our X% able to with performance. partially Next, XXXX, XXXX, XXXX demand and of fourth to net fluctuations. the of were channel quarter U.S. I in of XX%, million I'll were full fourth meet exceed XXXX. all in I'm LINZESS increase on will the X guidance quarter provide metrics an or begin $XXX by year driven and additional LINZESS. we pleased our details of quarter growth, that financial price

LINZESS year shown of XXXX, X% as prescription of full U.S. increase strong year-over-year, LINZESS were driven continued XX, an growth For billion, sales net Slide XX%. $X.XX on by demand

of quarter fourth quarter XX% to XXXX. the in XX% were margins the fourth compared in Commercial

full XXXX, margins with commercial year year XXXX. full the For line in XX%, were

Moving driven $XXX by $XXX revenues collaboration U.S. million. primarily QX, LINZESS to million, In Ironwood revenues. of were Ironwood revenues

fourth for $XX the collaboration income $XX revenues of For revenues respectively, the $XXX Ironwood U.S. was with million year, full million. tax Ironwood and the million noncash. full quarter the which majority LINZESS $XXX million of and year, In expense, were recorded

million recorded investment recorded million respectively, and the quarter full and in respectively, in full interest for the million million of income, Ironwood year, year. for $X the and In interest addition, and $X fourth and the in quarter expense and fourth $XX $XX

Massachusetts by $X net in for million tied in year in driven the and noncash to was expense laws $X fourth quarter. the a change approximately a GAAP full loss onetime billion XXXX. state tax

full from charge outstanding from VectivBio. revolving $XX for QX in $X.X full million year of In the quarter adjusted of cash. equivalents loss The million operations net the full loss for As fourth billion $XXX a principal facility million, repaying full respectively, the approximately billion Ironwood in in of and on our cash includes the and million cash acquisition balance and the approximately year. the GAAP for $XXX includes onetime charge $XXX XXXX, million with Adjusted also year was million a acquisition $X.X the $XX and onetime year EBITDA reminder, credit the in generated cash ended VectivBio. after flow $XX of approximately from the year, a of of EBITDA loss and

was revolver the As million. of on $XXX the end drawn December, the outstanding of balance

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

As primarily to offset single continued single-digit this LINZESS previously cap stated growth expect effect demand net January, X which the by U.S. sales high we driven high year. January driven legislation, price single-digit mid- erosion by in in on into percent, growth, low the removal of went by Medicaid AMP digits prescription

revenue million the Ironwood our of we previously flows million greater $XXX million, adjusted which with than line expect greater of in operating expect announcement $XXX of $XXX of in XXXX. We stated cash between of EBITDA $XXX VectivBio and acquisition is than and million on expectations

our potential up, than and a just XXXX. Ironwood a we we different with the transformational in have wrap year are ago, To we believe company a years few much we made pleased XXXX for very progress were positioned as company. we is

ahead, and we cash sustained LINZESS, and flows. on our delivering Looking advancing pipeline profits focused GI remain maximizing

look for thanking about Ironwood's We sharing our and you Operator, up propel can for key in to with to the the and continued line STARS forward next advancing III you by us, caregivers phase diseases. ahead pipeline close are performance. want we which line the and all may the therapies top their shared March. GI of questions. LINZESS of employees, patients, We strong dedication growth. for I believe to now advocates open of supporting results excited Phase catalysts

Operator

[Operator Instructions].

question the line from Jefferies. Li first Amy The of from is

Amy Li

twice will improvement patients CIC Apraglutide PK from despite efficacy. view on us. GATX X and showing this a PS as approval. Do it you On like improved relatively reduction to CIC, similar is daily compared to translate higher a sign looks Just that

how this? may be order Additionally, you walk and secondary through much us can finally, for falls you'll can CIC need force us in the the to any at hierarchical relative endpoints you sales how to that on you the testing give and to we model then where looking And additional should Apraglutide launch add color SG&A. SBS of that

Sravan Emany

answer I'll the on to start Mike it guess answer thanks, questions, X I can sales third I'll first by the Amy. over X Okay. Well, handing the force. and

Michael Shetzline

Good questions. Amy. Thanks, Yes.

Apraglutide twice it a weekly, extensively right, that twice maintain to parenteral it's a some or PK first sort and cover related AUC, and findings quite So sort the is program which it's ask CIC consistently sort from they portend giving the you weekly And support is, where times the they trough around looked we've doing or the Cmax you're did of getting whether reduction population. the a of the Apraglutide weekly PK this at to perspective. pharmacodynamic perspective best because drug of you obviously, time by had, with into outcome the throughout for of what question need question your is higher gives question sort better root actually and a exposure week. the in response and the that's modeled whether or of receptor twice The multiple you the of throughout of whether from

And support persistently of that the that see benefit exposure might better to We the the why potential that's opportunity once to why to available And or certainly reason reductions. think related weekly best-in-class. is has reasons receptors. chronically there is they an the at we having least that one parental drug think

but going that So of for we to from we how pharmacodynamic of to positive and a very that that. in We're it think terms the certainly aspirational consider response, Apraglutide. the profile study part PK/PD model is is certainly lot learn

secondaries. about second you The is question key asked the

population discussions XX. future agency potential parenteral sport the on endpoints, have secondaries at the total of Those really we are is secondary have one account statistically day to first label the language. the with So at X key reduction obviously, into taken least for week off the

a it's endpoint, the not it's So total population. subtype

the XX. times, many second And kind volume ], They XX. of reductions parental those week support we respond. week The population really we've The takes because support the support one the CIC, parental start to mentioned think Stoma that's and subpopulation as specifically third is in XX. for the one at volume at one enteral then endpoint, little and at longer autonomy looks week reductions CIC parental [ with at lower volume a things. And the looks the needs fourth at

Sravan Emany

think with rate XX And reps will that we be sales Ironwood. how with I is see a at that -- a to tied incremental we'll it's force investment rare force question. From disease don't this standpoint, then closer the selling we therapy At there though think get additional here our reps do to as think we -- sales against respect much. launch, of launch ever much XX have needs state to an disease. will investments the largest over We evolve, existing to very XX-plus

their we services, becomes patient a is this patient so the And and includes hub follow of services. that them. through model much service where There more support patient to have help journey

sales But affect spend that and don't significant is components XXXX. would some we've where incremental the in in force think of given So terms additional already terms and our of out we be our of not we'll in of ancillary we'll build guidance those team.

Thomas McCourt

Tom. is This

thing we're specialize think offices to reside. really these these with sales deployment is understand in I already in a lot the physicians today, of patients the the who force kind big managing of

creatively we're spend looking may There a that we're large effectively sales we sales certain I we we not at significant why accelerate that reason the at think certainly incremental the the taking in that's practices uptake of very that drug. force. look a specific that force. for very be an and But adequate have be will roles additional feel confident So some GI

Operator

Piper David Amsellem from question Your Sandler. the from comes line of next

Unknown Attendee

on David. is This Tim for

closer thoughts what on Apraglutide for to And we your thinking in data, the Apraglutide what's extent particularly materializes? of pricing ] are to As get generic on Gattex your latest a ex U.S., Apraglutide [ strategy Europe? latest your

Sravan Emany

Yes.

Tim. thanks, So

that. it. of we where still we'll First, on think before working strategy. some still in we're I I we feel terms time pricing, we've like I And to think have ready think some communicated don't yet that do price of we're our on

our that is. differentiated will lot think looks and tie actually to of profile I actually how a it like what clinical

start we wait of so respect which is With in that. And our on force and understand a the current we heavily sales open, to look, think, ex field that strategic we'll and U.S., we your question, data working I how we'll company. is until component about the have March think flexibility I second before our apra for U.S. about manner in very we're some U.S. think

Thomas McCourt

a this getting inbound obviously, going I of mean it's I business, of certainly we are take we're a interest bit advantage product you as and potentially to can best-in-class best-in-class imagine, something certainly forward. fair like having product mean, we but or move

Operator

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

Mohit Bansal

have I X.

a end with like mentioned, release the that the the in is, from secondary one you a much how support. forward the differentiated second the So the Could first expect about parental line look could about we information data. we you one just it you And little is as talk more question. see could well leaning as mechanism point to placebo And to that? March. impact bit do That's have top

Michael Shetzline

Yes, sure.

of just the [ that's the It's forward And one around prior sort mean, key really subpopulations in I the mean, endpoint. then question. in as a as That been the least a and stuff agents to support, give XX% been the I across X put of you day of phase may week gattex mentioned, of X, a other trying them that's kind the to and compared parental I class. we're granular on secondaries are reduction. the the that's between can out get the So day because been X like I one of But I -- was responder is you ] described the recall at use since days main ] [ the definition translated like roughly CIC. GATTEX and stoma that. responder standard

is weeks, quickly. also reason. support as stoma parental volume mentioned, to at the XX that higher tend week respond need more that populations for the because That's a stoma The we at point XX is have oftentimes they why

a of subpopulation, because volume value lifting And certainly And the study, week data then complete [ take reduction ] question, line we specific a is right? March often they think to respond. longer in [ second top The parental the a we'll that's finally, share which then about with is ] part the weaning of Entra to talked one which off at XX but And The third is the weaning CIC autonomy, of parenteral the support, you the weaning weaning aspect patients. is -- obviously, results. the support algorithm. the

aspect for the lower did been highlighting Stoma program at between though to program who even CIC because is around in difference Stoma. the The that a wean. and that the reason to smaller patients to ] this define looking called make [ XX% really clear GABA at became data, the CIC start differences the therefore, really with sort that endpoint [ urine of since and, in and post-marketing But output the the that the really parenteral or CIC and patients incremental real score has -- the CIC primary question And threshold reductions. Gattex not the volume GATTEX with became baseline in ] closer the gets participate into [ data Gattex it for days approach ] clear even of between subpopulation

happening weaning they the XX% about. if patients discussions, Could to the that's algorithm the the wean of a that honestly. endpoint, hitting for in so without And could decade, CIC external all last participate endpoint. is got And what were which lot primary

to and if than or all patients. CIC have ] patients increasing out, have It's in greater they're than saying, their diet, their and their subject body UEGW even weaning. did a don't open-label they like XX% data still go if XX% status we patient they're if you [ the and like they they respond status, all other they that STARS those then their doing well. and the they urine very of their is or XX%, a in but if study, at study, nutritional The weaning stool, But patient, wean can parameters. a did weight all well, wean. presented saw then used X-patient nutritional very input, through parameters, all and And their nutritionally in output, but the their were participate stool Granted and nutrition less small they in bunch the weaning line able hit could algorithm

response the a open-label you study. the good question, point asked the question And about to is that's placebo an so

we got So that study. effect certainly the from treatment

XX. in XX. per We had That at volume a parental XX% in to increased week week XX% reduction

we aspect look And your opportunity To so roughly we patient that therapeutic agnostic placebo of the certainly think about for there's population. the an response across at gain. point placebo,

response XX%. So CIC including think We in the the there even other with around with studies in for seen weaning placebo algorithm patients. we've what the gain therapeutic certainly room there's

Operator

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

Chase Knickerbocker

to start or wanted LINZESS the it question, I not. actually believe with

net one start. in on a just a or longer of about pricing on talk revenue pieces want to outperformance little that net a guide to deeper the from moving guidance. underperformance decline could Maybe different standpoint the XXXX assumptions. dig drive that bit So I

do in actually that that kind exposure growth erosion a some does driving pretty confident to little worse. assumptions. that different exposure erosion those like patient guys mix assumed And you assumption? So increased of kind Is pediatric pediatric of additional bit the what or makes Medicaid

Sravan Emany

point another year would and with digits. grow single be perspective, a I impressive past The going a this to consistent time, which we're it over single-digit from strong mind. high at very still it's the high Again, anticipating that's that in going my pretty XXXX. we're volume years, pretty to fact is volume still done in in growth say guidance our we've straightforward is, how

think the the single-digit single-digit in the low full essentially to today, at We year. price for headwind guidance that other to be fluctuations gave high have will And erosion growth any also Healthcare we mid- JPMorgan Conference think. and we

could Now headwinds not we have that do a of if some materialize, resembles last those year. year

that this feel over ] anticipate, change the last going the in at rules our from time, in the we years But Medicaid that's of business few we our a because a affect But Medicaid. over perspective year-over-year meaningful it's on for will us XXXX our on that year. price us measure. this just we this given XXXX where that It perspective given volume and a won't do been year, from point think be has headwind just to [ AMCAP a given book volumes affect there

Thomas McCourt

I is thing are entire that think growth across one the we seeing population. we're the seeing

important I think that's note. to

You growth, very in well we're look across to seeing total new all prescriptions Rxs. doses, strong both new overall brand, as as

mean very that's I So healthy.

segments. but very some we're across population promising all on our seeing in But some populations, it's business, growth, overall patient probably as seeing at it there point, pediatric in is a rapidly, growing relatively the percent of far exposure and think are of movement additional it's the this small Medicaid all health as but side payer We the population. pediatric I

but one extremely to demand know continue about growth. what And within be do to going the all control. So I it hit this responsive, promotionally we do right that's to in But appropriately think brand, see that in the it's point, have the onetime important this a to change kind cap continue most year. Sravan's to heading drive thing we to of is continues thing invest direction. the is we And It's our we're brand. this

Chase Knickerbocker

that kind If attempts back percentage, more speak a another in Tom. of of of I in kind guess, in On in And growth I you growth to then space out the high assumption? is kind validates pediatric tag mean, or portion price how and recently, way guys' your of the to bit how hopped medicine. dig And question, growth see to piggybacking population Maybe the at obviously, I your question into of early the kind XXX of little PBC. off queue. a your also the that. assumption? in And Thanks, comes assumptions. that paradigm? an portion just approvable this of what if thesis What kind we acquisition Yes. do XXX, ask from What pretty of before here, of maybe but kind treatment fitting too of volume plays

Sravan Emany

of indication. haven't guidance on size Chase, we the given the pediatric

still evaluating. growing. and them It's of I it's that the think through this we're small, extended We still year. We're still into pilots we're but we're evaluating some -- running.

earlier mentioned this think we I year. that

the so more we as granular baked into and the come know time, is guidance. course we'll it's want And potentially year. at Tom we over this give reiterate back said care the continue end is patients as this seeking good get to a leader, patients, more, guidance in patients, more see LINZESS. disproportionate seeing more on more I But what up news space. And we to that of market the our we're and coming share, patients

duration the satisfaction, patient effectiveness. and just is market which on and clinical access, on class-leading profile, the the Based formulary

team. the our of perspective is get -- a Simon think treat an GI space continue them. disproportion where With can as to asset we think an for reason we is also also found this respect diseases. great [ congratulations can Obviously, do of from we, to care. demand that a actually, the to a one just it we terms outcome and we GI but we -- CNP-XXX, the an We of it's So is broader -- a science a organization, in as space that, perspective, entered continuum. extension profile And of ] that's lot is patients Bay

I found modifying, this signs to be and behind So strategy. think Two, we our it's disease exceptionally potential the asset the poor within interesting.

and whereas of the this there year. As with destruction we market a essentially underlying the hypothesis, autoimmune have Mike symptoms will quarter had we actually more mentioned earlier, you for -- PBC, data third if other all therapies to the will we treat again, get on in you think the which --

and that validated stop actually we it's CNP-XXX arrest that will autoimmune destruction. hopefully, And that think

so we in be think will which asset And a differentiated this market.

And perspective. again, the [indiscernible] . congratulations But so to that's our

Thomas McCourt

Yes.

disease this really it -- needs that highly is focus a great on I news. problematic puts I mean is all this it care. is think better a

I momentum take if increases can and the advantage and we're it marketplace So think hopefully, really this right, of. we the in intention

Operator

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

Jason Butler

for Just X me.

you positive us are about STARS For the like signals commercial business? one, to still It's opportunity. could investing gating justify further said, but in following early, you pediatric items potential through you from regulatory in apraglutide, continue you results on then that the that just walk submission just thinking are investment and and a how seeing

Sravan Emany

so continuity just specific signs question we the with feel very Yes, Jason, positive or provide to LINZESS, regulatory pediatrics. now what a of but pursuing about really positive that and just and XXXX I'll -- worth size dose pathway. opportunity look, think will regarding between the Mike answer be of worthy Yes, on dose, again, for granular we think are first the to it's it's feel it We a early XX-microgram point start microgram too still to an this investment second year. new in from we on one, then and guidance brand, And will early it. as

pleased to now. want and It's with cautious small given something -- we're right we'll as are pleased investment. more, know uptake guidance just be return But a the with don't We on about we share to perspective. -- from how the given that. we so just we And just it profile that want is the more and growth

Thomas McCourt

our we're seeing a not in dramatic investment. But increase

look question. I focus running to part We're there's activity right is marketing Medicaid going equation our with has whole the the a pilots sales taking which number and regard And digital on this to pilots now, now. right we're of our certainly be pilots, no of critical to a we're mean exposure maybe think piece, where a investment. refinement I of mix.

So as be to said, going to what with I we Sravan cycle. point very but very the this with invest are how we're certainly regard we're we pleased money think seeing in very, at disciplined life our

Sravan Emany

Mike?

Michael Shetzline

Yes.

much delivering honestly, very clearly the yes, to the on March Phase III, in I for and focused So for results apraglutide committed line that. XXX% top the mean, we're that

fall all can in launch we we're So a have that are. that, for as And the of on. course, And then in which date still we we all will we between March. opportunity understand in then, see focused XXXX, where

Operator

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

Timothy Chiang

questions to head-to-head wanted [ And outcome I GATX couple But volume ask data data of that will and you have response how because March. wanted type clinical get reduction parental XX. at it endpoint just in the with of going and provide least your secondary time long ago. just I long, XX -- was Their apraglutide a to obviously, you obviously, to [ let's would approved good on sort measure mean ] from you comments obviously, ]. and I on efficacy looking a support at assume data of label, any at measurement. really not is XX% there's GATTEX like drug weeks a be with a the Mike, primary of But you on baseline

as of a [ GATX ]. sort Just relative comparator to

Michael Shetzline

Yes. Thanks, Tim.

reduction definition right, in So you're in other my exactly reduction to but into least responder. be a The at quite translates the GATTEX definition. parental well actually program required And XX% and to comments, [ the the end week. kind a this a of of X I responder that volume per day responder point support ] had alluded of

of syndrome requiring recall, was [ meaning In Advisory may all you're [ aware, week agreed down bowel it meaningful? is NPS Gattex responder Gattex fact, it point And you key to Committee, And the sort short ] day and ultimately for to it this know advisers discussion that XX% definition. a clearly, got the agency parenterol X ] does from came the support. at but approval a a and that, I if relate and don't

translate discussions taken us, X also as apart, a change. take day one key statistically they because the that's [ failure. XX% ] that I X endpoint, second you seat volume how And was whether with to with to as weeks if But parenteral accounted the short the of it's reduction why, correlate support the secondaries is use data, well if the which change little intestinal do and pretty those that's off the reduction gone translates CapEx much interesting day but your years you at have for the a nuance change volumes definition we have end actually To it point, responder the relative into XX syndrome the do They well the translates look agency. percent given it felt did. at or pretty even look it's X in from for didn't very you discussions baseline But not XX percent studies off. of bowl across glepa's a well. a primary nature quite regulatory it's So the the

Timothy Chiang

is of point they that's helpful, Okay. [ basically a shown the guess, [ And I parenteral I X-liter mean That's data that's sort like have needs, we between ground support obviously with ] X placebo. over GATX in and per absolute the ] Glepa week that that right? reduction and delta just about have the common or Mike.

that just considered wanted Mike? similar that can sort I of sure you that of if would So make I win, to mean, type be a -- efficacy, get

Michael Shetzline

you're that's with granular and now primary line because have the sessions, and continue Yes. be play to that's study going productive, things it certainly scientific usually more and to from perspective, the out happened which we'll Well, that us ] volumes. is ] the forward, will outcomes. relevant to sticks data, going I because of getting to us, datas top to a endpoint. come mean we're as roll statistically inform statistics to all first I Gattex later around forward think we'll right out have the delivering. mean endpoints run volume with roll now, then for A right multiple I Tim, like nuanced to the But those data a programs. just committed [ the it's the agency But the win honestly, we what [ how glepa lot of data the do primary

Timothy Chiang

mean, you make some I possible the to Or released of DDW? an won't at you data conference this like be might is like medical upcoming think able cutoff? do be it that specific more

Michael Shetzline

for DDW deadline last for this us abstract is December. the Well,

of kind that's statistically So But line, a top really -- relevant for the point. the there's is obviously we to track the endpoints. point the stick fast

So data be they are lot coming -- a to later. going of there'll

Operator

I questions, conference. thank us. and there all for thank further you for concludes now would today's joining our are This to presentation, like today's speakers no As

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Ironwood Pharmaceuticals (IRWD) 15 Feb 242023 Q4 Earnings call transcript