IRWD - Earnings call transcript Q4 2019 | Ironwood Pharmaceuticals, Inc.

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Ironwood Pharmaceuticals Fourth Quarter and Full Year 2019 Investor Update Conference Call. At this time all lines have been placed on a listen-only mode. And after the speakers' presentation there will be a question-and-answer session. [Operator Instructions]

I'd now like to hand the conference over to your speaker, Meredith Kaya. ahead. go please Ma'am

Meredith Kaya

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

Our press release can be crossed the wire on website, this our www.ironwoodpharma.com. found morning and

statements cause actual to accompanying forward-looking slides Today's results and call may statements. differ and Such that uncertainties involve include materially. risks

the available Form in as ended discussion under well SEC quarter is risk the of XX-Q our Safe and current heading future and statements the A Factors quarterly as on report Harbor for these Risk XXXX, our XX, factors on Statement September slide in filings.

of All to forward-looking Also statements date and for or not should be GAAP presentation, speak obligation which such measures, as and no we a statements. substitute to considered financial update to the undertake superior only supplement this a measures. non-GAAP are included of as

extent end the these comparable To table refer reconciliations of to our please GAAP the the the of release most directly for measures to at applicable, measures. press

with the year additional for detail financial Mark Gina upcoming across Mike close results and provide Mallon will During highlight our will McCourt II financial quarter discussing data Shetzline fourth Phase our XXXX by GI overview Consylman progress quarter; an will around full today's our guidance. will MD-XXXX; Tom portfolio; call, begin and readout of and our XXXX

be will referring We to slides via webcast. the

the of our section Events website you to the So go of access webcast please those slides. in dialing to

over call Mark. the turn will to I that With

Mark Mallon

to was GI leader to a for you. our everyone the focused with to launched US and full thanks And today. Ironwood excited in healthcare. clear with was a newly April transformative Meredith. joining share XXXX, as In vision company Ironwood Thanks, become XXXX a we are for year results

patients. we in area diseases. are unmet an one There That's GI real represents believe XX every for impact of where five large landscape can Americans million from have GI suffering a we One, need. The people.

is dedicated build capabilities these of treatment patients. to the innovation GI Ironwood GI knowledge, advancing redefining expertise for diseases, blockbuster the brands demonstrated Grounded care and and the with to in of standard

achieve drive LINZESS growth, the we of We're to out of sustainable order pipeline, three profits. our set in In these. vision, each against advance executing late-stage deliver and early our strategic stages priorities,

progress hit us I'd to detail. talk a our beyond. XXXX few in XXXX team and more With it the well for XXXX like substantial on positioning on and highlights then pass to to in of

half First, set Having IBS-C LINZESS; with the constipation. LINZESS one now idiopathic or threshold US prescribed is in in for cross product number of chronic XXXX. the latter foreign the in adults

by compared acceleration up in growth demand prescription in XXXX. These driven XX% results XXXX, in growth, were to XX%

past generic licensed Importantly, the XXX into doses we've a just entry litigation resolve outstanding in that patent XXXX. of March in settlement XXX with the LINZESS, microgram for agreements entered the the six weeks, and earliest

partners with expire We as looking our the also And forward come. which are for to working grow have to will microgram granted dose, to 'XX-'XX. a we covering the patent if late applications continue LINZESS US years XX formulation as of commercial as pending franchise to many reminder,

pain last data pipeline, mid-year. IBS-D. in Phase readout for on May, GI our we to study our XXXX a with associated track turning Now abdominal initiated we are II And with

become of GI exploring believe has number a but and relieving XXXX it the abdominal to initially are IBS-D, pain We for we potential non-opioid agent diseases. a

approved reflux three enroll be the of innovation medical for is regurgitation. XXXX in to first new the of for in disease would data trials decades. and XXXX patients treatment launch since the This continue could targeted second option the refractory If two our Additionally, PPIs the Phase first and to prescription improve be half approved, of XXXX. with over the GERD III pivotal

financial significantly our strengthened profile. we've Lastly,

To a important a profitability more year For we've running commercial report non-GAAP actions basis. are post history improved and our efficient Ironwood's taken both structure, our GAAP in number capabilities capital the full strengthened of a business. time and first separation on

term to position We be long will XXXX creation. that year another expect value pivotal we with multiple for us catalysts believe

be drive to LINZESS unwavering growth. in our will We efforts

LINZESS confident more continue for expect a durable come. are years to than is We ever asset we that many grow that to to

define generating late thoughtfully Ironwood lastly, towards are forward. each urgently profitability stage positioning, focused cash which We and two data will And to year, a advancing of strong readouts we're business. our important pipeline on this flow path help become our

on company is a that shown We of year drug. billion we were ago. track GI plus We slide. our portfolio, than our much existing today different on growth LINZESS come dollar already a from are believe future become this as very will to

be If you approved, could two add if beyond equally tremendous XXXX. growth XXXX believe there we XXXX, sized opportunities and is which to potential that

our and With patients would we that are opportunities well for on shareholders. continue well informed that and stay are fit broader GI objectives our care advance said, with create to landscape to seeking GI for GI focused and the approach value aligned within

continue We intend LINZESS we types that not We of would growth, our in limit to have ability bar our in profit. pursue. do the opportunities a forward deliver terms move to these types compromise platform opportunities, or of to high assets invest of with

like more I'm of short I'd of in I at accomplished the in millions proud time. by Before ever of the inspired us treatment of patients over am opportunities the also it close confident turn have has and I than what we to options front GI in in new by Ironwood. to very that team need a such Tom, saying

With that, to Tom. it I'll over turn

Tom McCourt

Thanks Mark.

LINZESS. year the the XXXX and Our quarter continued of fourth the full demand of year. Commercial first during us XX% as XX% for Mark mentioned increased With prescription over year performance was in XXXX by headlined growth

resulted respectively. sales in net $XXX million The strong demand million $XXX underlying and of

in market, the For growth see. a brand pleased in with its continue eighth year we're we the to very

impact improves attribute DTC overall of campaigns of LINZESS continue who XXs withdrawal of patients and continued that abdominal our impact bloating, including of of IIIb prescription And to our data, the factors MiraLAX the market, a and of symptoms pain variety suffer. demonstrating this millions the discomfort, the to Phase positive in

chronic one product for and prescribed IBS-C XXXX In the a became achieved and constipation. LINZESS significant number milestone

LINZESS As you lactulose, month constipation exceeding this see at leading prescriptions XXXX, was in can prescription the generating per treatment. generic approximately chronic in end the IBS-C XXX,XXX of slide,

focused over R&D net growth investment the has brand profitability, combined sales in including to translating million profits to was $XXX XXXX The Ironwood. LINZESS with behind total and $XXX In generated Ironwood. both substantial commercial million for expenses

to the realize We believe we MiraLAX. continue from withdrawal prescription growth will

choose physicians their of for more constipation IBS-C chronic more continue As to and patients. LINZESS and

overall consumers campaign this DTC launch symptoms expected Additionally, leveraging to about the with IBS-C. abdominal associated to the our spring, opportunity new communicate is with

a we including a successful time campaign seen every inflection new most was have We our demand campaign, launched XXXX, which today.

research suggests the We continue if expect be XXXX not our quantitative as trend as could this stronger. that strong market campaign to

primarily see XXXX expect high of in increased quarter, is be year positioned deductible changing in health the plans. typical to to health another to first the LINZESS. resets the Americans plans, using We and seasonality the deductibles strong number do due for annual

quarter later also a to The in tend first see seasonality the in can volume quarter, accelerated net the to in which We decrease tends both second with impact channel stabilize the of year. sales. during

GIVLAARI and getting the with already time the engaged, reps patients. are encouraged was Alnylam, from we our field. our and are we're hearing late Positions identifying are feedback by that field fourth initial increasing launched them are to the partnership Turning in physicians with potential the quarter, highly

and their week with including supplementing taking and symptoms Our were and are average. HXs from care are an an X patients of significant doubling a despite pipeline times X patients beginning X U.S., multiple day, adding reflux to [ph] these acids Many treat estimated with each million PPI dose, being GERD still million standard XXXX, and to from suffering in to there PPIs. on is regurgitation XX every refractory the their suffering on drugs

stomach As they sequestering PPIs, opportunity many these because patients their even evidence which eliminating the acid suggests, believe gastric bile XXXX though refluxing taking which we standard-of-care may the these into represents patients. reason bile is redefine the for agent, continue suffer, be to is to actually of retentive esophagus. acid, an they're

trials. evaluate safety And plus designed PPI screening in a far. in seeing uptake halfway III so enrolled and XXXX is of program identical XXXX. than by Phase efficacy refractory we're end trials more Our on to X nice The the pivotal a GERD of in the XXXX were

We top-line data target continue program to from XXXX. in second half of the

million options, suffering IBS-D, suffering fill. some clear pain from that mid-XXXX. associated current relief expect approximately Americans and lower We form and treatment failing a adequate With and there's from top-line a XX million study XXXX pain. evaluating abdominal there's to in we are can pain, need of unmet provide often Phase medical through Americans II GI XX with Now, abdominal Allergen IBS-C data

the about going I'm in to XXXX ask upcoming of Mike detail to study. that, results more talk With

Mike Shetzline

Tom. Thanks

different Our current a XXXX carrier that [indiscernible]. has status fundamentally profile demonstrates clinical

function. it GI believe abdominal with associated diseases impacting relieve can we bowel As pain certain without

prior important believe colon the in This pain test released further the and the many as be designed is abdominal to improve believed XXXX to community IBS down bowel tract we to solely benefits originates. in were very function. related GI in any than where the abdominal this is clinical pain

the on the with thereby previous fluid bypasses proof-of-concept in the originally was trial believe bowel limiting function. also small Phase where occurs XXXX. effect It demonstrated hypothesis II we secretion This IBS-C impact intestine, our on

bowel abdominal reduction highly pain tests. same the no But XXXX remained they the we a study, effect constipated, had on on still these though relief. that with one pain patients, IBS-C function. they in Remember their for that so that In appreciable demonstrated effect of relief as was even meaningful

IBS-C, current questions. Phase trial we're two answer the in II seeking In important to

this in abdominal least reduction XXXX as point baseline. in defined show pain previous patient pain abdominal trials, and LINZESS that XXXX a does First, responder used we population, using XX% abdominal a relief in and at we're from our pain similar

study, of of and saw trial XXXX. a previous hope an see LINZESS similar we this to in range effect what in the In we

saw in Second, bowel study an bowel As I IBS-C a the just Phase mentioned, with function? does we II insignificant XXXX function. impact on XXXX effect have clinically on

replicated if these to be We'll looking IBS-D data the population. in are see

The three trial, four XXXX of versus LINZESS times XXX in and of XXXX doses that this dose IBS-C We’re is used XXXX study. XXX, dose in micrograms exploring and placebo. the highest

particular the mid-year. top of finishing higher in doses up and to for forward be these reporting to studying that patients. We're achieved We're the can the degree pain results line abdominal evaluate look dosing relief

to Gina to it I'll our over discuss now financial turn results.

Gina Consylman

strong robust XXXX, XXXX guidance. external was as it in year, revenues here, our exceeding relates strongest financials. We particularly and I've since to the incredibly Mike. an been Thanks, profitability our delivered

with partnership our After our moving took headquarters future and separating Ironwood, few actions agreements the us to our years, included we success believe position several additional interest debt Cyclerion expense linaclotide which over lowers from profitability. that and ex-U.S. our securing XXXX Boston, restructuring Alnylam. new for we cash better actions next These the in restructuring

a in a XXXX As full following for year separation basis. non-GAAP the three we quarters result and a profitable the were the and on GAAP

made Over highlight the few the XXXX fourth we year next full financial of and minutes, will some the quarter both in and guidance. share I our full progress

quarter our million $XXX to of by driven in press Revenues in refer API. in $XX collaboration Please for the were linaclotide million $XXX sales million additional and release details. fourth revenue

margin commercial expansion in revenue. growth commercial the collaboration in the LINZESS quarter, was revenue. quarter to and fourth our higher contributing the year-over-year and timing driven impact fourth was margin by collaboration of the in primarily XX% expenses The

year, million amended ex-U.S. included revenue in recorded full from linaclotide $XXX agreements $XX license million, our to third and Ironwood resulting the the which revenues quarter. Turning milestone were in

the we agreements, ex-U.S. approximately sales from for as to of our to API in amended result, linaclotide a $X XXXX. is the API. no are decline revenue longer responsible And expected With supply million

to final we As ship partners. batches our

year. million our We in $XXX continue studies. $XX clinical million R&D XXXX, were and to we in plan and in full the to fourth advance expenses as invest R&D to continue significantly ongoing quarter

SG&A the were The expenses and termination due and in $XX primarily implemented is during lesinurad agreement license the quarter and year. million of year. in the compared cost to full optimization million the fourth to XXXX the SG&A $XXX decrease actions

now we interest $X fourth approximately quarter million connection and decrease $X year-over-year. year. our by Interest $XX expense the full debt In in restructuring the last expense with expect and to August, cash XXXX in million million was

With to of recorded our that to equity total said, interest similar cash convertible expense expected debt, to XXXX. and due total non-cash expense in are the be component interest

and profitability fourth full Lastly, we the quarter non-GAAP and year. GAAP both delivered for

was income quarter fourth million collaboration from the the The $XX Adjusted operations fourth for is full operations in the revenue from for was fourth million quarter. EBITDA net $XX GAAP and continuing year. our quarter $XX continuing strongest typically quarter. LINZESS million

not strong and This, XXXX combined timing We profitability in the with expect run-rate the sales for as a do fluctuate. resulted year. of will collaboration, this quarterly to the finish a impact expenses to API be

as we the from years. that million profitable, Adjusted even next tax $XXX is over for liabilities was year-end we NOLs important One $X and now reminder for operations have though offset continuing to them the billion of full year. EBITDA are in expect few

year-over-year XXXX net digit to Turning financial be or LINZESS minus demand our growth growth by to net range stable and price, in percent plus in XX%. which guidance, driven mid-single U.S. sales Ironwood in volume consider expects the we continued XXXX

Ironwood We growth also to revenue in XXXX range $XXX in $XXX due We anticipate continued expect for revenue the total be demand strong million the expected to in LINZESS. to collaborative year-over-year of arrangements million.

million be adjusted greater $XXX expect than to we EBITDA XXXX. Thirdly, in

milestone revenue from the a continuing the operations million adjusted the included of and ex-U.S. sales in As reminder, and API. license and total $XX XXXX EBITDA revenue

a for was Ironwood, term creation. long great for and value XXXX see, are can you near we year positioned and As

in Our into our our is to strategy our strategic position growing puts priorities. thoughtfully invest strong business transition capital to aligned us and a allocation profitability with

believe on can commented portfolio. value invest our where priority This Mark we is our we create and we highest expect As most of to the the earlier, GI advancement today. continue in to

we also which overtime, any for delivering a decision is threshold critical profits focused sustainable are We investment on make.

This enables and our down our pay debt. to invest thoughtfully us continue into existing to portfolio

settle portion to several have settle 'XX projections option And the of will as believe remaining XXXX years, we and in well. XXXX over in notes the expect convertible notes cash the given We current our our cash. next our to

balancing external our business pursue are disciplined a that into something criteria our we in financial have meets when allows the we investments flexibility opportunities us that we to find done. that way Lastly, the

over Mark Q&A. back With closing that, comments it some before I'll turn to for now

Mark Mallon

results. Ironwood. Thanks focused at take remain the members Ironwood recognize was and to of you. that favorable to I full year want outstanding a a the deliver work to for year XXXX tirelessly team moment throughout to these change

a headquarters growth, our company path GI and term the leading separation, completed to create the focused our start have We're vision and great relocated LINZESS U.S. valuation. on the delivered long a We for embarked company put in to right off on

understand We executing our achieve must areas process. sustainable That and on do goals. to to that more there said, delivering driving to growth, all late advancing our continue of is across pipeline LINZESS we business, focus stage

full ahead, through gained have the catalysts an We important we to year continue exciting of momentum XXXX.

saying forward thanks to joining And look morning so questions. we us I'll close this by your for and

open we line questions. Operator, can for the

Operator

[Operator Jacob comes Instructions] And your first question from Hughes with Wells Fargo.

Jacob Hughes

upside question first a to AbbVie the then provided and without though has been what the than year? in commentary LINZESS stable My morning. good is, this sales Hey, any your view, guidance? there to secondly, your can could better Ironwood partner? earlier factors ultimately mean back And I be are come with changes pricing

Mark Mallon

ask So first the take one. I'll the let me Jacob. comment question, second And Tom on to

expect with on Allergan. with at would you focused They're as as interactions about the limited closing point, had we've So, AbbVie before. we've fully talked this transaction

work has us LINZESS team looking They've success build Allergan. growth. AbbVie and with forward we've drive strongly engaged to capabilities future. to on to commercial great to Allergan stayed in with that continued with had really the working the got We're The

I've that, we open the options to said drive in also value to to past remain shareholders. really

with difference range that really will they And be hasn't could make of a open changed. shareholders. continue to full the options big that So to

is as the important portfolio. think they've all of part had else So them we've right say transaction of can I hear limited products to positive, so I interactions see we say that I think they certainly the closed with like that's with engage can been now would fully. to AbbVie what everyone about LINZESS in the we Allergan one start the that that them,

excited And so them. to with we're work

talk Tom you to upside? opportunities want for about

Tom McCourt

very, volume price, And XXXX still it's certainly right all, look recognize specifically, momentum we're Yeah. healthy on important out you the coming there with the out the first to a at underserved. of brand of I think spot patients now. in the is When of that very

very being growth, term price core payer That a therapy. satisfaction see term long and strong for as this role. high a of near for to obviously need that's effective said, as access founded continue steady success. a level one significant is of plays really well And more the We patient on foundations

else was industry here. a Certainly, affected pressure everybody there pricing year year a somewhat number certainly there's in factors was erosion. as where that really Last price atypical of some

look mentioned at we see As upcoming we this we year, that as stabilizing.

we We last year we so don't this happening about see far. from So X%-X% see lost in what price. year can that

for we're hey, We strong So, payer. proposition optimistic. have very we think a value the

obviously and contracts, overall, make we some But have of is some affect I which I will but of to brand But which on the stability may price decisions volume. very maintain payer some think did, the healthy. the our the we think

growth see we nothing think move we forward. as but upside I

Mark Mallon

Tom. I would just thanks say

I right. think that's

opportunities. Just of market IBS-C people the to back chronic constipation to satisfied. come upside large are This suffering question not and and about from is the

consumer shown to We've do continue what particularly we can with we space the we growth. to add accelerate really that as that

so And to we biggest consumers. the to that's see, I and continue really expand opportunity what where is leverage do would with

And has highly our abdominal of physicians patients. early still the and to communication symptom course, which impactful of we're to market into be research visit shown very data,

keep driving to growth. things definitely So

Jacob Hughes

guys. Thanks right. All

Operator

next And JP Joseph from Eric with Morgan. question comes our

Eric Joseph

further the Hi, measure that demand there's for and added abdominals that in of taking good morning. just on I the how are pains. a pains the their to not, put Maybe digit question targets Thanks questions. that certain you place if Allergan impact brand? And impacts the you guess [ph]? assessing growth the anticipate does to clarify guidance LINZESS, from growth mid-single just abdominal for

be Gina, we run-rate to on the for BTC use that brand favorable XXXX. then, XXXX shouldn't as secondly for we spend the revised it said quarter relative kind fourth heading about 'XX, a XXXX considering directionally effort? heard a that Thanks. commercial of How and I commercial should And also to looks thinking margin correctly, into you if

Gina Consylman

this of turn Eric, second your over Sure. take is the then Tom. to part Gina. probably it question first, I'll and

margin, the you're quarter. in So XX% fourth commercial the for right,

was really to nice So it see.

It was fourth just quarter combination our revenue. a for quarter of strongest typically the LINZESS is

revenue fourth time in was expenses again with we the around lower of level saw it during QX. just So this And well. quarter as higher coupled in

QX. expenses than saw of related the year promotion earlier our some we in to So in personal rather

the that's comment. So timing

do expect over So we we will to lower instance, see fluctuate where with said, to will we And seasonality see for QX, quarter-to-quarter. typically but that they margins time, grow revenue. continue level some of impact

to we But higher continue of to QX. versus a level in expect see expense QX

to So committed brand. of the expenses behind level our we're fully supporting overall brand, the

We expense same with versus in logged of the XXXX. plan our for in and have amount XXXX, Allergan roughly expect XXXX

Tom McCourt

far I we additional impact as of abdominal far you mean, think as know, as upside. as what will that the the be the symptoms

first note since to I curve that, think we a been launch. have very it's important strong growth linear on

order And what cetera. sources product, the expansion et business, in the dose, maintain with able activate of the of we be to to is throughout that the to we've which regards addition of new microgram lifecycle of to the constantly identify done, got and XX our claims,

about abdominal strategy, patients extension I more pain, identify mean, is most bloating the this, with with we what know further again, of in this is that identify discomfort. and not do they a marketplace, overall

DTC ask patients and help. raise we their educating to campaign, more our believe we that hand for So get can by through

the see accelerate patient our who optimistic to In growth far addition, did is. And what to the ongoing certainly see into and to as we'll But appropriate we forecast. that the the as, the we broaden optimize we're view brand. promotional upside of continue these obviously we'll try physicians' build of mix claims also

Eric Joseph

within the of expanded would this. resides dose the the expect Tom, of expansion one perhaps see Their impact dose uptake levels, XX microgram formulation? to for you

Tom McCourt

label Yeah, also really -- of these and lot this the the for physicians we obviously lower that the I patients. patients, think XXX But know XXX is the change the which IBS a in doses of focus will use was particularly. like XXX

we get So will what move growth I into the physicians, start pulling could provide. going to to very all I -- the additional well marketplace we on this and think, levers all really communication forward. think doses But going we're levers, until again, claim full not of and the we impact as both see to the across we're patients see

Eric Joseph

it. Got taking Thanks questions. the for

Mark Mallon

Eric. Thanks

Operator

next Wainwright. And from your Selvaraju comes HC question [ph] Raghuram with

Edward Marks

support guys This you for Edward presentation, Marks morning. XXXX appreciate mentioned the taking noticed there question. the the is in III Phase on you JPMorgan that to for multiple enrollment were I Ram. trial. I Good had for efforts

was what year. half you provide are those efforts data how that were just confident could of to you multiple guidance second as in I still whether top some can line this and produced the be wondering

Mark Mallon

Mike.

Mike Shetzline

certainly. Yes

fairly go So patients the over enrolled XXXX the to know XXXX including program steps robust be And III lot a as is procedures you through Phase invasive the trial have a like large Bravo. patients. of with to

enrollment in be will we So that that challenging. did recognize trial early

We question, desired have data and to basis the mitigate of your the kept achieve line abreast XXXX. of is of that which continue on a to point and point make end in top we very sure your the enrollment goal, adapt to regular and

those increase not recruiting, efforts to using outreach traditional enhanced or looking method internet newer to we the screening. we're just opportunities, include of where use actually even the Some at central ways

that some that will traditional metrics try we have efforts And using target to deliver the taking screening actually actually traditionally to be need into dive enrolled. done. above the up a a central technologies step to newer of deeper recruiting that's patients patient We're phenotype at

with more sites. in closely leadership work actually site. just visiting the also have team Marks We the are We

to the very engaged facilitate have deliver screening. in and that sure trying can activity make they their are so the sure we patients that study, make clinical everything in they we are We we investigators can do principal to able with to the

to know, through of then a these this go you that. little site invasive at time as require procedures some Because more

faster working to that and facilitate very the so sites closely with that that patients the so becoming we're And available. improve screen

Mark Mallon

uptick we've year. study of we we looks and -- the like think confidence by mean, we've mentioned with I been that I been we can the very have leveraging. actually seen encouraging innovative clear, be as these earlier, I deliver screening to just an the Mike, great in approaches everything So which the rates, has end that rather

Edward Marks

And China then be might much and work provide the I in was as XXXX Astellas' you from great. work what AbbVie's royalties Okay, projected guidance, as can wondering in Japan?

Gina Consylman

that and I'll So both from sides. take try

start to Astellas. going with I'm So,

the If started they royalties they mid-single-digits are, low-double-digits. Astellas to in the you recall the and escalate

Astellas recently reported the nine million sales. their it's XX/XX/XX. months approximately for ended revenues And $XX in

think So, specially. calculation the I you the do on math then

On we because but the haven't out don't called And they a modest would expect launched. seeking side we China, amount big AstraZeneca We only in XXXX. in XXXX just of later expect and royalties be in until guidance, within that reimbursement rather XXXX. our they've to are it in that's

So modest right XXXX. for now, we're very expectations

Edward Marks

All you. the I right, appreciate all details. thank

Mark Mallon

for question. Thanks the

Operator

your Trucchio Berenberg Capital. comes Patrick And with from next question

Patrick Trucchio

good morning. Thanks,

question in XXXX top the The II similar as expectation first regarding data top, improvement II expected Just trial. just is Phase Phase midyear. line the prior pain and see to

is dose the IBS-C times four the valuating, the trial, trial. this dose highest During

high we what I'm II So baselines effects the are anticipate. if midyear about, in at which year. limiting concerned any the relief And there wondering we particularly magnitude that's pain Phase side trial this from dose expected of dose

Mark Mallon

Mike. ahead, Go

Mike Shetzline

of Yes. Thanks good important those to clarify opportunity a that. XXXX. around points very for It's some

doses So II. X trial X taking into that dose the used now the Phase you in times the as we're that we've to mentioned, is that IBS-D

know range. limiting we confident dose in didn't we any actually side really patient effects that one important the the very Number from in Phase for see II safety the We're in population profile IBS-C that is X dose reasons.

including to X dose up And Now that XXX micrograms. including grams micrograms healthy volunteer up have effects But see point studies. was limiting we tested to in or didn't your to diarrhea. we any other X,XXX side around studies,

actually healthy diarrhea in no study fact, reported volunteers volunteer healthy In

So But again, colonic the and safety profile. is Again, IBS-C. more fairly the mechanism and for population XXXX, ongoing, know about of distal patient we're blinded. delivery of what the we confident in IBS-C a this new is the trial action, so data is the based on

seen that in one concerns you been can tolerated. safety tell no I fashion blinded it's expected we've fairly But and well a

So date. we're fairly the in to profile confident safety

clearer However, that year. the will when much obviously see mid this become of data we

Patrick Trucchio

collaboration more to that just Ironwood's That's believe proportion what terms regarding specifically of secondly, Can commercial can discuss the Ironwood helpful. of GIVLAARI launch And patients discover? you help of commercial then contribution in on Alnylam with Alnylam. you the

disease GIVLAARI then the what that more can to has expect helpful tell of launches? agreement be And liver other could should you commercial come? to we be secondly, first And for rare us Ironwood data

Mark Mallon

I'm So But Tom last XXXX. on have going to just question. answer that comment one

So, talked about captured our the we pain think, well, you profile. course, add Mike, effect Phase I view want to I safety that, the on it that And just II of seeing to study.

diarrhea. explore Obviously, that's XXX not doses, to dose of results been even of the be really the getting higher there something better response could a of able that, possibility with the we've beyond because micrograms, risk the

be we starting might terms the doing exciting beyond So, based study But possible in haven't we of data, certainly, see going to [ph]? is the what that. is this point is the we're learn on why GIVLAARI already

Mike Shetzline

objective role and Alnylam, it's gastroenterologists the working with I about far as primary our about primary disease GIVLAARI. Yes, really key and is as docs to our educate care certainly mean,

it's And is great from many really these pretty us, these lower are is things a patients. severe confused because cardinal the fit know IBS one This -- people for we as symptom do with of suffer of abdominal patients that pain. the

a have do powerful sales at ours think, to within It very a gastroenterologist. to as as is, opportunity going the of what large some with the about a have these And as we I effective be force, patients, know tool. they all as them, and So, GI really consult community. ours point,

as with regard candidates could drug then there Alnylam, likely as to them kind we've pulls number once begun to very all we to through and far patients, so the off really of be work, patient. patients, now mechanics those seeing encouraging, getting identify we're reimbursement mechanics GIVLAARI. identify who signals early we The of the hand And a for to

So far, communication very the is mechanics have worked effective. well. The collaboration and

an orphan I learning, explore. space, understand this I going does disease GI is us And it to with in a what as continue you we're hepatology this mentioned in it's something arena. the take to to to think successful, think for great be

mentioned with rare Mark to there's number diseases, related some at clearly have regard GI a including we that, opportunities the diseases looked in of science. which other emerging

So a we're to there's lot experience. this of With far. of encouraged going we've a I GIVLAARI and seen possibilities coming so think out I lot think what we're learn very by

Tom McCourt

if think mean, just to that that capabilities in quickly are particularly I I helpful well I opportunities partnership rare this have are and as we two there diseases. as be core with are add, there going that future

of ability physicians to to necessarily involved. course and testing difficult is, are office the on a patients one staff to These the there's find, patients work So of obviously ground. lot identify the with

the are office staff, then have being these the we success critical to think, factor the they physicians and strong really of help They their databases, use having and practices, is the really to able And relationships phrases. have I to and sort place. a in relationships that is particular, analytics and advanced identify in use with second that data deep thing

for enrollment certainly been of within applying been some techniques these we've looking practices to how for But inset. XXXX. we've also full the patients in already And accelerate identifying

strengthen further just this core capabilities. So I think those will

Patrick Trucchio

Thanks very much.

Mark Mallon

Great. Thanks, Patrick.

Operator

with Cowen. comes question next from your Peaker And Boris

Boris Peaker

have on study studies can study Maybe the Thanks this successful? label of are more and year. do actually a for all to this comment site II is midyear taking on a XXXX. you when just the need Can you if you timeline doing the be would Phase the timeline on that my positive ultimately to pivotal questions. What's readout

Mike Shetzline

to Yeah, data the top so mid Phase thanks. again study committed this line year. II for We're, we're XXXX

Phase is study trial. we a Okay, that fairly actually as think II robust

of will the formal So with program. will II in a with institute the consult the place. we half rapid need the to III FDA in trials pending the this of results for Phase Phase And meeting design we year, recognize XXXX that agency of put do to we latter during the

And to better, We're as hopefully. Phase sooner, as things least beginning as pushing next that it even certainly but start of the program that early hopeful do as if possible early we're maybe we at to and by do soon XXXX. year, III could go

that IBS-D one available, need meeting, the it pivotal have and to do size the II we given obviously you're the think in opportunity breath will need an rest program program. we timeline or Phase when the we of whether of two sample commercially studies IBS-D terms of size one the be because In do end asking, just Phase the to do study and could for we II

And also relevant submission. sort our desire could to of which an do IBS-D supportive be other to we indications, think

think a And make so of now, soon I II right that there Phase sort details the that as final little but committed to determination do that starting possible. program as we're premature

Mark Mallon

dose effect as understand, to potential important the push this we've have the the obviously really to a us pain we look bowel at it's And mentioned, dose. think the of which is effect this I from think isolated we've I optimize of as the and a brand, drug. allowed Boris, pain we've -- has

But we see different a this brand. as complete

IBS-D as is is I think, line a this the of as that first to market as far of want the likely its as be a will drug. -- demonstration extension We LINZESS. pain. do pain this indication we purely have be enter to to able see not

that all of diseases But significant abdominal forms pain well all as probably beyond where GI ourselves then going -- other into symptom. lower IBS as a there's we see well

here that's for really data So out coming the real opportunity us. open up could

important rebrand a in is this to in unique say, us I position this But the spot it and important it's to marketplace. to think going be for really

Boris Peaker

any to you. also as I'm to have any this, curious, docs fact are mentioned that a that using you Got you sense reduction, drug. GI essentially pain given control just saw this as pain? exactly lower the you of pain Do do currently

Mark Mallon

Yeah.

of one you're in of the immediate as the first the constipation. we the think increase release secretory current formulation all, diarrhea. generally the challenge one push Because the of I effect limitations that's of include and dose, of going But risk the disorders yes. drug increase that -- to pro

effect But a clear very of see relief we also the ranging pain. on dose

differentiated Yes, docs it's I see it also affect yes, from broad most So drug a other that's this getting treatments. docs, But function. does pain very application. almost bowel think as all

Boris Peaker

Thank very Great. for my you questions. much taking

Operator

from with Morgan comes David next Our Stanley. Instructions] Ledowitz [Operator question [ph]

David Lebowitz

question. to for Thank that? evolution would the forward much compare of needed be you How to To experience When very for be What how a last drug like would you marketing off to XXXX. potentially you LINZESS taking went? the question. done my look that expand the launch

Mark Mallon

Tom?

Tom McCourt

lot. We've Mark. about was the lot tremendous marketing LINZESS We success Sure. in we're an like how mix a product, awful the learned Tom. time. delighted. and learned the look This is what commercialize mix Thanks, a to should over marketing

learned the said. XX,XXX saw from between the a And XX% XX% about be we've fairly same the we that -- largely fair group are as somewhere XX,XXX with being drove what early IBS-C. of smaller a with LINZESS physicians, going growth. It's growth to is of think to docs I to is early prescribers, these

think this So secure efficiently time. to a certainly commercialize product I we path reimbursement more as over there's forward

not only on some things I we that learned we the the we leverage of So capabilities LINZESS but that time. us over also can think built

do of get electronic more proactively symptoms? hand patients course, the through How how identify we we point alternative? their to raise Mark's patients databases. based And efficiently So do the on what's

patients than These abdominal these these to pain treat symptoms. lower patients alternative no other opioids, have

So I learned think again lot. we've a

I to positioned of particularly increase commercial, were as organization. an selling the as well the we think effort really forward overall productivity the move we

David Lebowitz

analgesics? talking would be population getting patient So, right nothing treated the a they that over are using or either is with just or opioids typically counter about now we

Mark Mallon

done They're the has to studies has severity using of a use have in an of a that certainly lot increase mean, the population. been that been There of everything. showed it with in this of do have opioids the pain, right? past I number

a in symptoms. using manage we're NSAIDs, things are aspirins, industry they're -- using control. I everybody lower trying get the are yeah, they to they is all to Obviously, using abdominals that healthcare mean try kinds under of to But trying

treatments really I But affect a are of unique unfortunately, very most mechanism pain this could abdominal these that of mean, is symptoms. lower these insufficient. management the

David Lebowitz

taking questions. Thank you my for

Mark Mallon

David. Thanks,

Operator

now the And over Mallon. back Please turn Mark call would ahead. go like I to to

Mark Mallon

the any people confirm, have to we in and queue. just operator So additional don't questions

Operator

Correct.

Mark Mallon

in course Thanks. on continue the sharing interested during Then time the your the we and year. to of everybody Okay. appreciate call, exciting thank just I Ironwood development and Ironwood look the forward

Operator

Ladies and for concludes Thank you participating. conference this call. today's gentlemen,

You may now disconnect.

Ironwood Pharmaceuticals (IRWD) 13 Feb 202019 Q4 Earnings call transcript