IRWD - Earnings call transcript Q4 2018 | Ironwood Pharmaceuticals, Inc.

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Operator

Good morning. My name is Emily and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals Fourth Quarter and Full-Year 2018 Investor Update. [Operator Instructions] Thank you. Meredith Kaya, you may begin your conference.

Meredith Kaya

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

for slide www.ironwoodpharma.com. Safe accompanying in Our only statements our our of this or Also included statements quarterly actual a be available to a the forward-looking website, the report results considered to quarter-ended morning is release involve financial and and call filings. Harbor and press crossed non-GAAP not under that substitute the SEC the for as are materially. on measure. can risk the XX, found on statements the in risks obligation and Risk which to well on Form we factors may and statements. of differ include such as as should these no be forward-looking of Factors XX-Q supplement slides date update XXXX, wire statements. Statement uncertainties earlier All superior measures and speak Today's September to current Such and cause future presentation, our discussion undertake GAAP A heading

For reconciliation, end our the table please the release. to at press of refer

both financial Ironwood reviewing slides by We'll question-and-answer XXXX an webcast. begin via to and comments teams call. results Mallon available and Peter of update call, overview Cyclerion Gina Peter discuss Cyclerion available separation. and New During financial today’s on the for for referring Consylman will planned with Ironwood. will an company's Hecht close be on will the will provide the We’ve portion guidance. and Mark then management follow the to the

I'll the With in, of dialing section access website it to you of Peter. that, over the our events webcast those go to please to slides. turn For

Peter Hecht

and XXXX upcoming prepare Meredith. year a work announced momentous Ironwood. thank separation. our all morning. this was you planned to for for for And the We core we us advanced and business joining Thanks, feverishly

for two launching each the important are patients to cusp deliver to We independent of medicines poise value companies, publicly on now shareholders. great traded generate and

going moment. But first new through the to operating launch We comment highlights of take the two are you I to the on companies. want in a

potential provide Over $XXX the Cyclerion leadership up quarters We raise Form CEOs investors both and and of Directors. group and details update past financing great Cyclerion in XX with both should setting success. with public progress companies the additional engaging for important We to named to the we and the Board plan new towards at statement, We million, recently first intends which least months, a with with of you and to teams filed soon. on million this $XXX several and financing runway. eight current participate made the registration we’ve been between of companies, our of

Over brought to team around the believe in past generated seven patients LINZESS has we millions various drug patients lives. world hunting compounds we to of development the of stages years, change tremendous potential have that XX and our additional

point. of this has to that proud here are team get work the the done We to

to potential CEO the separation. and it With upon be who for about excited both very I companies. turn Ironwood will my will are We over new Mark Mallon, that, colleague, friend

Mark Mallon

and can million. delivering generating aligned a grew we profitability With nearly say leading top for the today line total We’ve more to strong joined And who see set to I to LINZESS since and cash healthcare clear XX by GI marks Ironwood. can growth. I more from LINZESS, grow our In do XX% on GI with brand in franchise. to Well much Peter. development days still launch, LINZESS, the begin excited grew is market prescription this of revenues bottom continues year brand. Thanks, I since XXXX patients opportunities believe priorities: and a I $XXX benefit have profit. there branded seventh leader to year-over-year even $XXX its class, X% portfolio, the be million company millions and accelerate of I'm its become

were acceleration drive First, withdrawn the to clear in first we prescription XXXX. we which hand growth volume market end six you by November XXXX last are capturing seeking the patients the prescription on saw on previously the And at as LINZESS in left weeks break continuing of of in who year. of the from with see of slide, MiraLAX, was can

to prescription year-on-year up New XXXX time far was is growth new in last flat compared comparison this year, the actually to and growth prescription XX% so as in XXXX year-over-year.

by very start. encouraged So we are the

Second, effect soon of our communicating the are these that and including trial symptoms data exploring we from discomfort. Phase midyear Linaclotide Linaclotide intend as as beta If is datas begin bloating we patients expect them abdominal positive, pain, to to on X possible.

will differentiated Now data pipeline XXXX and GERD IBS-D and trials, enroll evaluate are XXXX pain the heartburn. from million on in we GI our these for trial successful, turning and the pain. Xb have a there most opportunity on what preparing Linaclotide trial abdominal in trial are then from a category. XXXX evaluating heartburn the from the was with product improvements was of quarter. the bothersome initiate With from for to suffering shown XXXX our stage people GERD that expected across XX the order two clear an them to in a second Phase U.S And Allegan can PPIs frequent There of in and this to XXXX, are pipeline. extended-release persistent shows with in symptoms. X we the promising majority GI. a in symptoms associated profitable Phase In from patients half of suffering million company. U.S., If effect second is we XX IBS-D. Shifting pain severe this predominant approximately XXXX late The taking suffering abdominal both plan of range candidates, the In GERD, with estimated XXXX, was the symptom. which XXXX complex with over following we continuing on We're persistent we with with as operations full X for highly The expect completion effect well XXXX. two Phase to generating of and of We’ve second we to of diseases the the now and continue a on persistent be on the provide abdominal third to to profitable cash trials priority, of significant our with a It's plan become HXs. separation. more non-GAAP, this in we priority. steps guidance important lower regurgitation a data

on expect part large And revenue ways to cost driving delivering of explore and be begin positioned to to is -- our profitability lower sheet profitable, capital. we our growth overall as ability translate in dependent to strengthen becoming better to position Our we and our on margins. expanding balance

team we three felt summary, future it we the need effective and difficult taking to tremendous a This more that efficient value. was announced morning we're but shareholders. a decision, necessary create after actions We to by create Additionally, this asset, approximately patients significant to is we to make have non-sales its decision the capabilities and XX%. fantastic its of strong and for In our Ironwood, deliberation operation. one a our workforce reduce

doing is at our post-separation development LINZESS, sure will promising cash opportunities deliver we back everything Our With first profit. all and turn to that, our I core. to portfolio Cyclerion. exciting on business order generating can Peter, you in We stage late strength about the maximize must and we're this begin make to the

Peter Hecht

to Cyclerion that Cyclerion the potential Thanks, a serious super We from distinct greatest orphan for the Mark. going sGC relevance and that sGC stimulators five pathway is unlocking treat. of and programs just do turbo-charge And that. patients for the they has comes our advancing for intend potential the to about separation, tailoring of to excited power the At was startup, diseases. believe I’m portfolio differentiated generate be to value diseases this full to to for shareholders. tissues designed

is and doses going to our of XXXX activity. of in preclinical over neural each XXXX, strong diseases. with disease. for Phase Phase results trial up health fraction. pharmacology because Olinciguat the whole with it to have treatment We including And translation new an the clinic a companies. nitric some of systemic and of the IW-XXXX. a nitric vascular important stage Gina that, number I’m cerebral clinical utility a we improving this data flow, with oxide three that’s discuss X a to the in R&D of financial brain XXXX, the we believe blood exciting in in and barrier, demonstrates inflammation preclinical tolerability CNS leadership disease. enter into single is preserved for designed And of multiple XXXX, role is to and in trials. readily team failure very our enhanced really of our from first X we’re and critical cognition. allocating CNS the praliciguat, is a heart launch Phase reduce company. trials, treatment and CNS crosses sGC sGC cell importantly, sGC the being into neuronal stimulator stimulator both shape The research team performance capital PK in diabetic X pathway, prosecuting penetrant of to an define ascending X provide And expand and sGC studies, expect sickle function, of Cyclerion, to to in XXXX stimulator opportunity neurodegenerative the serious pharmacology increase and with cap activity Phase safety, blood started opportunity explore to including plays fired on just great We to turn ejection in currently and study that experience Phase oxide have We markers studied one catalysts sGC regard four XXXX two the to going guidance. in nephropathy development X At a readouts The once day pipeline really have With

Gina Consylman

morning, good everyone. Thanks, Peter, and

XXXX Over next year-over-year to minutes in information. expected Ironwood performance the our to guidance. and financial financial and release million. in $XXX the and refer fourth-quarter grew I highlights, $XXX financial Please be to increased against the million guidance XX% XXXX press detailed for fourth XXXX few XX% detailing revenues full-year quarter our will

ending of fourth as API quarter Astellas during in fourth and compared sales continued API the million quarter $XXX million higher a the $XX were launch. XXXX. million $XXX its $XX margin were Astellas to commercial full-year quarters revenues to support fourth-quarter growth sales the year and LINZESS million sales Total U.S fourth net mentioned, full-year margin primarily higher commercial quarter was driven XXXX XXXX. sales by were LINZESS XXXX the for in full-year Peter $XXX and the to and profit Japan. and As API million build $XXX in previous million in were the sales in and with to in XX%. Linaclotide expansion inventory

API We SG&A. operating fluctuate were expect Total sales million for $XX million, continue the in R&D expenses quarter and million fourth $XXX quarterly. in to to including $XX

$XX demonstrated XXXX strong financial our million expenses XXXX with R&D assets AstraZeneca recorded the see For lesinurad $XXX XXXX our non-cash slide. as to the $XXX you were $XXX licensing including We of and the intangible operating quarter million impairment in $XXX and full-year $XXX full-year in and in performance reminder on million expenses. million the in ended all with XXXX, We of that million in SG&A. operating include related cash A meeting million financial agreement expenses in third guidance can separation investments. total

from to $XX following: API Regarding $XXX of today separation in discontinued $XX the million the we to of expects expense Net LINZESS total be and in Cyclerion Once commercial reduction costs announced both to to XXXX, the force revenues contribution business reported related to $X revenue ongoing and be results the operations. Astellas. from sales $XXX as continuing to interest million to be to approximately expect million. expenses the directly and be separate to million new total associated $X range as of range Ironwood million, the the million, Cyclerion, $XX of costs restructuring including Ironwood reported million in approximately Ironwood with operations, of

Ironwood. net a continuing important guidance operations at expect As Update we provide of XXXX to to separation. separation. specific following for be an do loss anticipate on continue from non-GAAP a in We XXXX our year the to an prior is basis Mark In to Investor and the plan completion summary, incurring Ironwood profitable mentioned,

of to become the We With of are distinct companies portfolios call. separating two creating turn experienced portion both Q&A value exciting with value each patients on to alike. will position creating the businesses promising teams, operator and strategies, the for these very that, leadership over cusp the I that begin business call the and them to industry-leading shareholders --

Operator

[Operator Instructions] And our line the David of Morgan comes from first question from Lebowitz Stanley.

is line open. Your

David Lebowitz

move question sizable of much on patients are my question. still taking XX-day slowed? a this transitioning a prescriptions, very I’ve there prescriptions. the to you guess, or generally for I Thank number has

Peter Hecht

Tom?

Thomas McCourt

Sure.

David. So, thanks,

I we’ve think, one, near-term it's seen been a nice opportunity some that lifting.

One, two for longer think grab of there's paid prescription of are a generic clearly no which certainly components I the that their laxatives, this. able are we’re refill and patients those. capturing up to portion

in that it With seeing eroded in we’re the more is the other our which actually piece has faster, is the marketplace, growth looks even encouraging. markets

the that choosing very the longer is it's LINZESS clearly So, to and no therapy, a fact attractive is pick prescription option, prescription a choice. physician

more to prescription near-term, on kind even I still majority option to certainly are not but the lots with think see still so One, The XX, -- we preferable. physician choosing patients in a a we grow So for the of up the way. prescriptions. patients regard to in when the an grabs two brand longer-term looking opportunities. and is of for opportunities, LINZESS XX-day And have yet room of people that substantial prescriptions need, is

David Lebowitz

much some a sort gain necessary? for approval for that more based One reduction in also alone, being very possible would Is IW-XXXX. you regurgitation be the of it question data pain that. or to on on or heartburn responder Thank

Mark Mallon

those So is heartburn. in endpoint on studies the primary frequent reduction

see the on endpoint, of you approval to which a to endpoint, physicians. expecting improvement positive important And drug. we plan, the be so that with that basis Regurgitation statistical and primary significant in secondary in able the will is we're be of is that. So would the the communicate an a to

David Lebowitz

you very Thank much.

Operator

Our Geoff Barclays. line of the question next from comes Meacham from

Your open. is line

Jason Zemansky

taking call. Good Jason for morning, for the everyone. on This Thanks much is Geoff. so

on $X.X Just a filled at quarter-over-quarter relatively looks number of number have was unique like the It patients LINZESS question the quick who flat million. prescriptions.

forward, going up some XX that down? length about that mean at to patients. opportunity is of number And curious number slowing -- of would the of million forward? you. of this XX was to to patients to accelerate? And of with unique you’ve or the take then What regards kind Just start for Thank there something that look any when million moving number overall that kept number kind talked you

Thomas McCourt

[indiscernible] Thank to Tom. you.

Okay, let up pieces. it couple break into of a me

the -- RXs in on the excuse is RX mind with to is having First, to year-over-year or significant regard brand new the size thing of me, to a patients. One new impact new count, keep total total RX or prescription overall particularly count.

bigger, So over December, are overall suppresses as growth the the into size of the -- prescription brand it we've is very obviously, its What we seen to carrying starting in new looks as seeing a patients getting somewhat improve really in January. increase prescriptions. of is the dramatic like

months over So the new it we're an certainly like acceleration of to looks couple brand last with to patients. seeing regard

that Mark driving why new mentioned can marketplace patients claim we the as all regard is far to been abdominal we with Finding symptoms. the forward, the additional as think really that as our we with before, which most wanted identify is patients haven't this able real look face about that we is don't motivate identify in think as with I earlier, to and challenge growth They demand. opportunity abdominal broaden mean pain. we bloating I motivate, to I discomfort. the actually reason

consumers, have to think growth. significant we our and a certainly upside accelerate directly So those claims within having messaging we will

us. we And think access be at the front of I will patient have one, to our industry high The you, agree physician broad really core payer as in there's right drive think satisfaction now tremendous So strategy is are opportunity I and an and reimbursement. about with a level as demand. leader, I market we where of

Jason Zemansky

much. Got you. That’s very Thank you helpful. so

Mark Mallon

Tom. Thanks,

Operator

the Our next line question Boris comes Cowen. from of Peaker from

is Your open. line

Boris Peaker

study. Great. any we’ve just Is interim wait Thanks questions. XXXX the an I’m to analysis results? my study the taking or get built for curious into there till to on end

Mark Mallon

of Mike? R&D our ask to that Shetzline going answer to Head I’m New Mike question.

Mike Shetzline

interim discussion point, our that, agency it's take to we Yes, XXXX but back to no into no the forth, thanks. have will with but there and program and we were there's been currently built if is your do that interim. Currently discussing something

Boris Peaker

maybe fit, find the risk Ironwood, future And company the also you for in become the if you and kind strategic such [indiscernible] I’m you for a general to you a just at curious question think to goal on mentioned you. something acquisitions, specifically of Got profitable scenario? more a is expenses mentioned or split. that when the and for goal you're just forgo that willing that be obviously to the and profitability new is profitability you -- post take foreseeable looking is maintain in would that

Peter Hecht

profit. to And cash plan time. I Our the yet sure of sort capital really behind is to we that at positive quickly accelerating ahead goal haven't possibilities is on development. We and LINZESS, -- me. I continue of grow view moving business as said, to least flow -- [indiscernible] That’s commented for profits we’re days And clear getting our the and get profits. to on really is what making pipeline commented of use grow we our -- the for can over as for for are no leaving opportunities and our as priority we're haven't maximizing

Boris Peaker

my just question. last Got you. And

For praliciguat, that to need what consider justify later diabetic for and to the success a development? data this see nephropathy study you year, do future

Thomas McCourt

question. the for thanks So

as UACR with data X to praliciguat. the we or the in randomized we'd undertaking currently have we The second of two probably be the diabetic and to a partnering. go we’re It's doses is nephropathy in of half effect expect anticipate urine. a but going or this that a urine study earlier, XX% come compared a primary greater will be So to this placebo program Phase amount in to And forward the is trial endpoint there, protein control mentioned -- year. the protein in

we will how looking of data with might it be partners to potential entire forward. move -- so will about that package decide And at the

Boris Peaker

taking you my Thank Great. for question.

Operator

Raffat Our of Umer next Evercore the from line from question comes ISI.

Your open. line is

Umer Raffat

what Hi, to about LINZESS? things. the [indiscernible] enhance about negative structure on that of adjustment [indiscernible] your My talked first of in improving and you in and what net versus think guys. much. XX Trulance rebating portfolio, etcetera? could the the auditors you possibly Thank sales million One, my question telling Thanks focus was how speak partner. audit if the to [indiscernible] a new wanted place that you know as you prompted your to taking I by for communicated dynamic do perhaps auditor secondly, question. you very what the the [indiscernible] the what commercial And difference was I XQ couple

Peter Hecht

So question and the Tom I will question. the answer we first then will think Gina have Tom? take second

Thomas McCourt

continue will their the payer thing is the they And volume the to beginning -- products is got a think you’re and I situation us capturing doubles on -- growing as increase three doses access focus to our of market Yes, efficacy if we’ve continue order to dose as have they in really well attractive again, and double third, be have and an from to double we more which as critical differentiate to the always very -- our having that success. said but one do market which where price payer. brand, or the

pricing seen the with what gain But previously we've foothold not been been aggressive payer. in the I that marketplace. competitor able has is to has in a think the that

and situation strategy a how and a have what think be there obviously going to we’re pricing their [indiscernible] see how forward. to lot of in to to But to continues opportunity we transition obviously But where want lot but proceed. growth, move we’re -- some move have wait forward. how see we there, going I things tends a pressure just see continue as I think will out to to of they we're to

Peter Hecht

Gina?

Gina Consylman

do what conduct I the the can question. process collaboration second regular just are take This by and earlier are LINZESS basis. a our I don't LINZESS we because of Sure. standard or reported update the we Allegan of in net process LINZESS our our a is and This our part that’s the standard financial a This on from audits one. materially first said new statements have internal update Gina. really is the with partner we sales financials impacted QX where repeat have not is a by calculation. -- our controls

have process future. hopefully expecting. we we do that news standard aligned frequent not and magnitude around. of this adjustment a good very that more Allergan an XXXX. will closely So It a more will And was significant But been calculation to reconciliation even the a this were the time in rise level on working the have audit begin we that with that we process, in adjustment is

Umer Raffat

Thank you so much.

Operator

comes Huang Our from Ying Merrill America line of next Lynch. of Bank the from question

line Your is open.

Ying Huang

for taking Thanks my Hi. questions.

sales. first is The one on API the

then, understand that profitability? feel we bump think capital a be And the any for launch considering the color don't capital? that last non-GAAP big raise you ask need your on the given see Do to XXXX also there's secondly, why revenue Ironwood, that. by Astellas, So there's need additional You to up that add Any think about China? given about would launch we want as Thank new should Would balance I how additional line? in AstraZeneca to but the cash helpful given will need you of quarter. you. for

Peter Hecht

thanks for questions. the So

don’t year think regarding I actually we've still So our Japan provided going to in an still guidance, the the API -- of to sales, phases for inventory. launch. of is continue early and it's this sales They’re I some -- to guidance but building in think from the

and seeing showing. be the in then But and encouraged that quarter-to-quarter from by the a basis. continue we’re sales Japan volatility that are demand So is Astellas the the will will sales leave API demand commitment to we

a the process, a and for get final In to very hear approved. everything but news several terms in sort we're pricing it place to take There of launch. excited that that of China, is months it will was

potentially opportunity expect are could with healthcare of reimbursement to see take it time and But -- that opportunity LINZESS. little potentially to start in have from place and very a and suffering sales longer-term market. and benefit access an could IBS build patients potentially don’t to being IBS-C they from big significant A get to that from million -- will we that XXXX. have bit XX wouldn't in So chronic

Gina Consylman

just launch. I API AstraZeneca, comment arrangement. the arrangement like that significant we want of to collaboration are have. the one will do a that Astellas final similar the add The we arrangement markup And economics we on more Allergan China to a selling at at not -- with be

Peter Hecht

XXXX, Oh, profit going our and don’t yes, to a the and capital over growing will this to we're raising is we envision -- from at cash business that be sure making the focus need generating that be profitable time because be time. and

conditions so that’s course, change, will and your plan respond answer needed, we but Of if questions? that our opportunities Does not in today.

Ying Huang

you. Thank helpful. Very

Peter Hecht

Thanks.

Operator

Eric the Joseph J.P. Our Morgan. next from of line from comes question

is Your open. line

Eric Joseph

taking for questions. Thanks guys. Hey, the

partnership think I’m is QX around thinking the data? what of point product. for a you a commercial you wondering At Just longer-term to how any margins LINZESS peak I thinking specifically abdominal margin from claims? incremental about sort about announcement for to with how your symptom it's guess, and IW-XXXX, partnership whether are point, just curious ahead about it. potential at realistic And latest marketing of this this commercial Thanks. of are potential the the thinking investment on

Peter Hecht

-- questions. So the thanks for both

about excited claim. abdominal the we’re So symptoms

both consumer the significant think brand and the is reviewed thoroughly sales and think I we force the order today. behind I've the investment I of magnitude investments, right. have

-- if We allow if heard sorry, increases that. promotion yes, that apologies we to than will us room, some increase -- do stand in will will if stand we But you we responsiveness noise we ready see in more ready there's more. the do see

at So well-positioned to data. basically ABS we're the launch new ABC

that have the If comment partnership to ready will XXXX, it. In not do point. in there's place do I��m I this to to on regards more, and it we monitor for opportunity we will right resources think at We closely.

that we -- be but are about will point. be we partnering will guidance any We to at -- certainly discussions it's in on this give premature internationally,

Eric Joseph

Got it. for the Thanks question. taking

Operator

of comes from Wainwright. question Raghuram the H.C. next Our Selvaraju from line

Your line is open.

Edward Marks

Ram. might know Hi. Edward I and want This just on to China? markets Marks affect these there Chinese between and the Japanese are the any notable is for trajectory the in how similarities if

Mark Mallon

reimbursement. differences there this significant Mark. two There are the primarily is -- between the markets, in So some pretty

So basically the and pricing and of is beginning approval Japan launch. reimbursement from almost in

there's to have really and that quickly. have level. made at in And reimbursement In not get it although accelerate reimbursement process takes gain so you also a that. nationally, just their ultimately reimbursement province the potential to substantial It's China, approval actually sales still getting about they’ve do improvements longer accelerated, to -- get

so in see Japan the rest that I it's the And disease it of we both it the takes across provinces. and in follow China. and to enroll from should time through that world say a out with perspective, IBS-C, in line

a very benefits the unmet we but about will be it's a both, and are in timing so excited the patients significant bit So need different. of

Edward Marks

China? net from are sales generated AstraZeneca how royalties in And the on Okay. booked be

Mark Mallon

Gina?

Gina Consylman

the what losses U.S with is threshold. the The XX-XX is Allergan in the collaboration. really the arrangement that have AstraZeneca in similar China, a we and we very it's certain in profits difference is where It into only U.S., to a XX-XX, we’ve with with China up share

assume our financial losses So the initially. statements be will recorded of XX% in

Edward Marks

in provide have R&D Cyclerion kind terms for and of And the the Ironwood will on split then both can you. Cyclerion? of obligations of R&D in projecting you’re future any reimbursement towards you Ironwood general, whether Okay. any milestones, on budgets those costs, Thank just some guidance And things?

Gina Consylman

Sure. I’m that. of going take part to first the

statements guidance that additional of was make is we And to to and XXXX, the part reporting the one separate on based change it expect operations the trying we’ve it date today profitability reasons solidified this half between script financial point not because of once of guidance are we my to of while and continuing I -- committed So during the we able first operations. separate. the the providing the will distinction now are and delaying date. exact in our of the split and exact And at providing and that timing continued to just we’re that is that of

on give a a we’re last at Cyclerion you right filed side can been now. to basis the -- least if at month could public would indication historical Related take to So R&D, not little what color Cyclerion bit just why give the Form a incremental that’s look an and we you has providing was on of spending. our of that related guidance XX projections, it to you on see the

Edward Marks

all I you. clarity. Thank appreciative the Okay.

Operator

next the Patrick Trucchio Markets. line Our Capital question from from of comes Berenberg

Your line is open.

Patrick Trucchio

Great. morning. few on just Thanks. had a I follow-ups XXXX. Good

Xb, So was the the is primary overall the change heartburn heartburn the Phase at on from severity. week percent primary then eight. -- responders X, baseline week Phase eight in proportion at of weekly And the the

So few this. questions on

remind year the study? And I this study? that year definition endpoint heartburn meaningful? can Phase Is differential change? X on we XX%. X consistent Phase of changed you. X? Phase -- led was be why First, in the primary discussions the context was responder then you some give next placebo severity compared study, that you next us second X, us is in in lastly, to the to the in the to clinically was the in the Phase is around weekly in Thank heartburn should XX% how agency believe Phase X expect And Phase nearly half is And the the in what can the the -- or Secondly, your different reduction with determined X the

Thomas McCourt

I’m. answer Chris questions have to Mike going is your newer even are since We than

So Chris?

Christopher Wright

That’s Hi. right.

the think primary I question endpoint. your So around first was

developing with study. responder So into the FDA developing discussions for in and X about process the our Phase had the part compound primary the X, of discussed Phase the in criteria as we -- was endpoint a

actually and you until So study at data the criteria do what the would its the look uncertain response be. proper

different responder determined would as endpoint degree change meaningful. it so we to was the of X that utilize -- terms how so had we primary to of exactly and determine and Phase how for And study how X a that criteria why and our in a the do study endpoint, -- we utilized Phase primary to we need because determine we that's that a

change is of the and be they a reduction. the the to percent with that effect. patients So Phase define ask based improvements meaningful in agreed XX% in review of questions considered symptoms. study, that in heartburn terms to different we and to percent that we're able as that the described, of questions the through the their the lastly the then of magnitude on be those meaningful we we we X relate clinically change FDA what to of considered well And and number what And course study with

variance that the effect would I the reduce success would similar and make mean there we magnitude. that enhance our the made in a try strength expect study are we some were enhance of likelihood of possible. as I as changes So sure much to to have the to

the Phase even So better power I that think types it's similar changes likely -- part study. of to make of we're some we that see made than X effects. study of hopeful the the the will We're

Mark Mallon

of to design. add of a and couple reviewed data if potential X I absolutely think that in as the that are free or days to picture also leverage something Phase will XXXX communicate got days, we benefits those them reduction data heartburn to all like the technical having in reduction critical like having the or bigger perspective primary, that the need and having that change of captures definition in is of communication. consistently the positive a like able regurgitation, secondary the a really to heartburn We've occurring is in we of study patients. The FDA and and most -- able free of concept then that’s study the heartburn comfortable of I secondaries benefits, types the a both the sort be be in physicians heartburn there to endpoint the from just increasing

benefits very physicians So study confident that in communicate the positively and if patients. that reads to we're I’m able the need study going of out we do confident everything to the and be we’re do to

Patrick Trucchio

you helpful. That’s Thank very much.

Operator

next of Chiang the Our Tim comes from from question line BTIG.

is line Your open.

Timothy Chiang

Thanks. Hi.

study? terms I in Xb bravo Phase -- were to study in types enrollment the are go maybe had X Phase How back Phase topic wanted you at it of patients enrollment, around results that good of study such in looking how seems guys your positive. the of the to you in So XXXX, X just like patients those many

Mark Mallon

study have bravo actually So to requiring erosive X be of was Phase esophagitis. Chris all to both signs as we've and to, alluding the patients positive

to reflux So we sure and make saw do benefits patients patients, that these but way disease to in in -- confirming we're best these the most want benefit that’s the that. we have -- and that acid really

Mark Mallon

patients news frequent may and to with whether have have include I be responders of to had range was heartburn, they’re fact required suffering we or speakers] we which sure erosion that clear, They I’m all the was but baseline for [multiple the just had PPI was esophagitis The important because this them they is But us drug erosive, to -- greater it's they’re have speakers]. [multiple saw bravo to that of FDA be that of with benefit a the positive. with or a the long be encompass magnitude be that in get consistent from a may not it exciting what to to people discussion not placebo. not of non-erosive a because are got over likely to very erosive the want those.

we very, are And sure GERD heartburn functional I fact that I and have in feel trial diverse collaborative all population, we design eliminating us. finalizing so very the good that think we're by the making that FDA sure was and about think positive patients making very bravo with this

Timothy Chiang

certainly pipeline. It's a to for in number high And on great. companies Peter I -- trying is unmet certainly of a had sickle there medical Cyclerion find need. Obviously, the just are there follow-up cell a Okay, high treatment disease. one

sort Just how alter significantly action potentially? treatments could these there of product you back out the are the of do how mechanism aren't benefit potentially wanted go think any, that or olinciguat this to you patients but to think for and could olinciguat

Peter Hecht

patients. tremendous the potential and need very the study excited on will in help and agree on unmet mechanism Tim. a the the we’re for about design? cell, sickle of pharmacology a to there's follow We little Thanks, terribly Chris, the olinciguat bit underserved market and

Christopher Wright

Chris. Tim. Sure. for Sure. Hi, Thanks the question. It's

of damage also remain many it's them there's daily a symptoms very great do you something there. up need there from that cause sickle in a There's symptom disease. really sickle organ that mortality. kind domains of disease, is are underserved high the if end at cell opportunity which still unmet people cell we particular believe and very And particular and of look dying in and the So in

and broader are symptom one there then that that but the that but or don't overarching clinical therapies features currently the and symptomatology BOC So, not target they disease. sort target of that target of are of range are some or there domains, being developed anemia, some target or another of only [ph], domains symptom the the

there is and So very there. is high for need great mechanism there we unmet our we believe believe a really that mechanism

its as So and cell and hemolyze nitrous the disease, probably oxide level. to deficiency reduction they NO a in sickle disease basically binds causes you know cells is where heme a

out consequences sickling prevents we oxide of because hemolysis, can't the red the of many spills arginase consequences produce related, also And disease cells the and nitric and downstream are believe deficiency. that You to of directly of the also of NO. NO production blood

and inflammation related directly vasoconstriction, NO reverse we are vascular with to increased blood deficiency the we can decreased olinciguat, basically all believe So and flow, effects. those those

and elements nice which find the targets olinciguat in profused our sGC act. the highly organs the of between very match way we so pathophysiology the in several which it vessels stimulator And a the

You have …? or other Tim question,

Timothy Chiang

studies last sickle study. there's and on Are fully Maybe ongoing I guys the cell, just that patient. question study? the know enrolled not been olinciguat you many one quite in a that’s few with

Peter Hecht

Sure.

olinciguat to study. and of in And the randomized second trial half once-daily. dosed been placebo. this enrollment year. of study to XX-week it's you is So It's we controlled as has the process expect a data know three Olinciguat have of a compared the currently different of in doses

Timothy Chiang

Thanks. great. Okay,

Peter Hecht

Thank you.

Operator

question next from Koffler Irina Mizuho. Our comes of the from line

line open. Your is

Irina Koffler

taking very bit any broken much. is revenue next more details included just that in out have get for I anything guidance that Is on the maybe that Thanks guidance payments year, you potential to or Thanks guide. the that API for And upside? milestone wanted estimate? else there within Hi. question. any or little a

Gina Consylman

is Hi, Irina. This Gina.

We any have milestone both guidance. collaboration and sales. LINZESS include not It API revenue in included does the

to We be sales continue and that fluctuate next flat will believe down API year. quarterly, they to will the

Irina Koffler

you. Thank

Operator

will closing today. Peter And that questions it back is turn all the time over we I to have for for remarks.

Peter Hecht

participating this and for for Thank in. listening you morning all much very

a on Thanks if we're Her follow-up please the through Have available And have release. As Meredith the coordinate throughout your great is day. take information always, you press to day. questions questions, again. Kaya.

Operator

does call. today's conference this conclude And

You may now disconnect.

Ironwood Pharmaceuticals (IRWD) 13 Feb 192018 Q4 Earnings call transcript