IRWD - Earnings call 3 2023 | Ironwood Pharmaceuticals, Inc.

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Operator

Thank you for standing by. My name is Aaron, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals Q3 2023 Investor Update Conference Call. [Operator Instructions]

I would now like to turn our call over to Matt Roache, Director of Investor Relations. ahead. go please Matt,

Matt Roache

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

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

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

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

go section over turn our With to for to accompanying that, call so those I'll Events website slides Tom. slides you of the of in, includes webcast please separately. dialing Today's to the access the

Thomas McCourt

morning, everyone, us thanks Thanks, today. Matt, joining and for good and

taken company the the made progress we As with industry. health strides care to leading on the our the priorities, we look in the and across are realizing become we've the towards our GI strategic end of back year vision pleased approach

and clinical As you maximize over while its expanding generating by us we come demand strong flows. driving continue the to years, utility expect from to growth LINZESS robust cash

track future net growth on on continued to of third the X% between remain about growth are the We strong on guidance performance our based this potential sales year X% encouraged its quarter. LINZESS in of deliver and and LINZESS

Week, XXXXs. And apraglutide. into excited horizon short from presented Gastroenterology XX-week oral for at late-breaker featured But which strengthened progressed just the intestinal unmet about importantly, data We and GI a the company we ago, high treatment year, United our the be bowel European potential syndrome a STARS billion in of need. in has we to for the year, growth net this bowel acquired Earlier apraglutide we we final this have the syndrome the positive colon-in-continuity, believe its were including more peak and presentation. extend which Phase during also of our VectivBio, the investigational potential in short intestinal II weeks study achieve failure, areas $X failure asset few development with sales lead and portfolio couldn't for Nutrition with in

STARS the colon-in-continuity short in those We be bowel including analog high to the syndrome spectrum failure, potential believe program. these highlight for clinical of reinforces the data best-in-class for with whole patients the for conviction our intestinal GLP-X apraglutide and

our the with or development pharmaceuticals option progress program cholangitis of and agreement primary the CNP-XXX, and of treatment therapy biliary PBC. our potentially the In portfolio. license we're addition, also for the the The core building CNP-XXX design of of examples to a of disciplined are structure disease-modifying excited approach about progressing

in assessment the specificity patients showed the treated of T-cell an early T-cell CNP-XXX, effect CNP-XXX to opportunity rationale PDC-EX scientific for on This is and responses very review antigen encouraging. sound the with the response. The target, evidence which provided of

Together, these improve data also us care that have forward. of GI diseases. multiple clarify the in have And in positive for life have that opportunity key programs we we confidence quality across our of managing pipeline front of our improve will path with and standard tremendous patients reinforce the our developments help potential to upcoming

Our advance and optimism commitment ever strong and GI to assets as develop is innovative it's been. as

with growth GI. ability who forward which on XXXX will GI and positive believe come. a patients pipeline believe momentum are like propel for our strong we to positions in would the LINZESS finish the us over excited mission review We continued in and value detail. strong the to across create I the uniquely We're our the looking programs of key will shareholders it performance Mike, for to be pipeline now our and in very Mike? to about catalysts XXXX, combined more to to in turn Ironwood's ahead leader years

Michael Shetzline

apraglutide absorption burden below associated SBS-IF of reduction lifelong maintain significant Thanks, life. or support on growth failure SBS-IF bowel Tom, failure survival. nutrients syndrome provide programs X. normal intravenous morbidity, parenteral quality increased results to the in necessary and function high-economic minimum and intestinal or and organ for administration with good update intestinal in with morning, delighted health, of everyone. on reduced intestinal pipeline and with is to on nutrient starting I'm leading and fluid an to syndrome due Short with short-bowel our fluid severe failure dependence to from Slide mortality,

fluid two colon-in-continuity degree and different distinct stoma that dehydration metabolic On colon within parenteral a a on lack infusions since to stoma They needs. These a support and reabsorption loss fluid to colon-in-continuity sufficient Patients support require support are more Patients more XX nutritional often fluid lifelong SBS-IF often parenteral volume. we than populations the with makes require may of as week. patient and XX patients are those day dependent days up X highlight often have referred CIC. with for to colon-in-continuity, higher Slide challenging. for typically absolute of than X, with have hours

a greater than of enteral XX% presence the distinct achieve a patients of better by to population SBS-IF colon represent have CIC parenteral SBS-IF to may our which altogether. opportunity currently of due functional the patient support with autonomy, treatments. market and available underserved the elimination is patients Colon-in-continuity

Slide Now X. to

we're positive Nutrition the open-label study. about final data with the intestinal II benefit of first As ever GLP clinical is with evaluate GLP-X the STARS the bowl mentioned, Nutrition study Tom to failure short excited colon-in-continuity. Phase XX-week -- in STARS from dedicated syndrome a analog specifically designed

see XX% on volume XX, with XX, XX% at can volume support a reduction a statistically was reduction week parenteral you maintained As the week effect at reached significant Slide and XX.

found support conviction week acceptable well a profile. effect patients baseline. testament reducing durability with intestinal on improving at clinical achieving study. those a at of to the support our significant At and volume compared per per a support safety were defined improvement, and in of the patients These responders, shown Slide dependency parenteral absorption And day main which days least of patients XX%. XX, of week an all X.X X as Apraglutide on data CIC the at to of A Phase of parenteral or independents. week high parenteral are be as III allows more least patients achieved days tolerated in support. the of parenteral week XX, apraglutide was XX, gained XX% X X patients strong reduction X.X At reinforces to

parenteral study approved. you baseline which the support study week We're the endpoint, successful with data weekly III GLP-X Phase conducted line designed has in We looking Phase in efficacy in Moving top The to XX. colon-in-continuity XXX at standard includes largest potential STARS and believe continues from patients change to stoma for and and in once-weekly trial is SBS-IF, therapy is XXXX, the GLP-X to primary as Slide study's care forward patients The CIC as to XX. and been updated advance. expected we'll STARS March evaluate ever to apraglutide has III and volume population. the both SBS-IF keep patient improve if of the stoma the only relative

of XX, On is an portfolio. Slide view expanded our

a evaluating the transplant, react is bowel is among treatment graft-versus-host asset in as individuals GvHD. failure, host patients addition for and apraglutide will occurs In with most affected to mediated tend The the common intestinal by syndrome disease short prognosis disease to host versus we're for tract and evaluating GvHD potential Graft patients. sites immunologically the also undergoing or stem poor against gastrointestinal allogeneic GvHD cell these recipient. in cells hematopoietic immune donor or severe where manifestations of with

the in completed Phase from study of 'XX. is this first II and Enrollment quarter is data expected open-label

and the the progressive the for potential disease a is response primary CNP-XXX driven liver fatigue ducts. autoimmune cause an root which not of slowly autoreactive damage result lead and This PDC-EX uncommonly debilitating and as the the T pruritus symptoms well treatment irreversible disease. PBC transplant. profound antigen, in of and bile biliary other can liver the destroy underlying as in cholangitis. by Now ultimately rare requiring to may scarring to The cells of

Tom the strong the As peripheral clinical we program, to cells. this behind science T opportunity given had assess mentioned,

impact We're showed treated we rationale with disease which PBC. the data We third potentially expect in encouraged T-cell patients an mechanistic we which CNP-XXX early and in progression line of results could assessment, in quarter completed favorable the response, the of evidence supporting 'XX. T-cell by believe for responses asset, top this

it alkaline as cause II plus endpoint liver the precision truly disease. patients root is no study in medicine, game-changing excited it a a tolerability, that the on progressive because Phase As are reminder, market phosphates. introduces the in potentially there primary this PBC CNP-XXX for We're therapy includes new of therapies about address safety, and change

IW-XXXX, syndrome. area. cystitis to significant for a asset pain and on potential wholly of need Moving a this unmet in bladder treatment Ironwood owned interstitial There's the

are millions forefront is time humans, very Phase in we're market a will about this be to yet be treatment this of of executing tested area. the progressing. development. currently Americans, it program as the As this and We're the the hypothesis development II We're in affects crosstalk at proud or currently study, in excited on which there is proof-of-concept options condition few clinical first

a the forward in transformational We're organic company catalysts evolved diseases several exciting for GI addresses with Ironwood with year Over XXXX, past that and serious potentially robust Ironwood patient a highlighted of we've looking with the Sravan couple from an need. III into high with intestinal top GI by line and years, that, LINZESS's pipeline unmet study of over line short leading to With syndrome failure, turn ongoing top bowel in data in performance. XXXX. the data it the Phase third the in review in Phase CNP-XXX STARS I'll to II quarter from March to study

Sravan Emany

good volume XXXX. of quarter growth, XX. In LINZESS delivered Mike, I'll everyone. of quarter, and quarter the increasing morning, another on third third versus the Thanks, begin impressive Slide X%

growing to a market. ages XX% were care believe reach a X health future prescriptions the promotional based again, XX to specific year-over-year, professionals this strong feedback including efforts, and from we promoting patients, there suffer far. constipation. and have prescription FDA once is market Since to continue We geographies, June patients have continue and opportunity assess so new approval million in children from growth, pediatric roughly and LINZESS, New-to-brand appropriate we'll received who that drive choose the population, to adolescence significant functional additional growing demand reinforcing pediatric in X response we these great gastroenterologists been expansion on LINZESS in

as look We opportunity, we potential Meeting, patient recent and of the prescribe the American help into by care age encouraging. help LINZESS group, investment very forward we continue inform health level updates Gastroenterology, to Pediatric the to this will Annual excited Hepatology Nutrition insights to at North to number We're met this a in gain sales Society with professionals. net which ability pediatric XXXX. which and providing Additionally, for more is

update the Ironwood provide brief planned. I'll VectivBio is progressing ongoing of business VectivBio on The Next, and and a integration operations as transaction.

new As on apraglutide remain ensuring progressing our continuity, integrate, business continue learning to expeditiously. we we and from focused colleagues

reminder, the third expense notably full results, quarter flows first financial the impact quarter cash VectivBio a acquisition. As and operating from include

Swiss merger We of remaining also to acquire continue to under X% shares. effect the squeeze-out VectivBio the outstanding steps law take to the necessary

year, this be additional We this completed. by of process updates to this provide process is the we will expect and completed end once

details additional financial quarter provide our on I'll Next, performance starting with third LINZESS.

$XXX by on As prescription $XXX quarter, sales prior in the XX, Commercial margins U.S. of to compared revenues of growth line U.S. XX% driven increase million, the by Slide with quarter collaboration shown million. XXXX. driven Ironwood our million, full net were LINZESS year-over-year, LINZESS $XXX year X% X% guidance. primarily of were revenues an demand third in strong year of versus XX%

which million the Ironwood of in recorded income $XX third expense tax the majority quarter, was noncash. of

$X in million $XX $XX EBITDA costs was interest and other million net recorded investment interest $XX generated and was GAAP in million. expense income Ironwood financing addition, In and million adjusted income.

the generated operations credit outstanding approximately million with cash. quarter, repaying revolving and After third our in in from facility $XXX of cash cash cash flow $XX quarter balance the ended million equivalents. $XX million and we In the on principal in third

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

our Moving maintain meaningful forward, we and focus to cash flows. profits on continue generating

portfolio our We through will prioritize capital value to investments the opportunities flexibility our of and while paydown to structure development debt LINZESS, maximize maintaining progress capital deployment. for manage evaluate additional the

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

remain We XXXX strength in year of the are LINZESS. guidance reiterating continued full confident our as we financial

billion includes million Ironwood $X.X an one-time X% to and continue adjusted the between LINZESS We of of approximately million of to of which sales charge $XXX between and X%, growth from approximately loss VectivBio. expect million U.S. EBITDA acquisition net a revenue $XXX $XXX

the operating flows. charge, an the one-time adjusted of representation cash Excluding EBITDA is impact of approximate

up, are our with third year. quarter a we to finish looking and to we wrap the are forward strong results, pleased To

cash positioned We innovative on and and sustained GI well continued portfolio progressing generating profits flow. delivering growth are and and LINZESS, for our strengthening remain maximizing focused

phase excited advancing about caregivers close their us, which performance next and advocates and thanking GI of employees, pipeline the continued patients, of key and of We supporting we launch all shared help to believe are our ahead for to want catalysts dedication by will growth. therapies LINZESS for disorders. I strong Ironwood's

now line me open the let for Operator, up questions.

Operator

line comes Butler. of question first Our Instructions] the [Operator from Jason

Jason Butler

quarter. on Congrats the

me. Just three for

the seeing if the expansion of label pricing on predictive any, can on you're Second, LINZESS might or the then help quarter the in apraglutide, enteral LINZESS, speak the what, in impact that to how you the the how responses had outcomes? can T-cell of you clinical speak on just leverage what lastly And speak to fourth autonomy value by magnitude one, you into to reimbursement? speak can for can quarter? and and to First CNP-XXX, improvements

Sravan Emany

Yes.

With for So and I'll first functional to Jason, second X and approved pediatric offer to hand third. for get I'll to to only as XXXX to one, our extremely prescription respect to them able the from patients over answer constipation then the first therapy LINZESS patients we're excited the ages Mike guidance, XX. be the and suffering

indication. any guidance Our sales X% the from to full includes of impact X% the for pediatric year

sated a guidance given. pilot pediatrics we've we it's from So I we'll XXXX year expect come take to really where at this minimal in opportunity promotional reminder, as Mike, the we the that year. and for next XXXX before, kind already the as in assess contribution the of will focus give be as And these we we're think we do on programs and start as to think what we at, we back when of question? next for size want you guidance

Michael Shetzline

Yes.

was question autonomy apraglutide I program. think the on the the for enteral

burden patients oftentimes, hours of because a question of and to important administration days a economic they fluid said, connect for suffer their as themselves IV have with an require actually a it's sort think support huge who because parenteral for this week. nutrients have we to X in multiple SBS-IF day from I and disease

patient, So but to every autonomy completely Is your is a financial reducing huge support. also autonomy, that on need achieving improvement we happen question economic that remove a things remember burden. you by the these need enteral burden significant is a day, because On for but day the on for or enteral requirement parenteral it's X a where even

you support to IV enteral the need to every why fluid day. yourself a tether administration parenteral is way longer in autonomy curative need because that's no So related to

achieve a products patient that colon-in-continuity in focused approach, that we our prior really also It's the we with population very in important and it's think opportunity this on understand population. we potentially important haven't autonomy. to why that's great think have population consideration So a enteral to

Jason Butler

lastly then the on CNP... And

Thomas McCourt

proposition very disease. The obviously, therapy, the to other lend very, sizable. I does available there currently to And I manage. a thought strong. a established heard out is One, Mike part very is the are opportunity. how is already burdensome of pricing value the which question patients there's as really was point the this These certainly really costly this with here mentioned, And price

a more So population a I or... broader can us to going in probably the a far position to profile basically the patient strong put which as very think cells table we're is manage looking talk the that would significant T a at clinical obviously pretty bringing good can enter market the we've in maybe, Mike, as about and where you how we into And market. been specifically way

Michael Shetzline

Yes, sure.

strong okay, And response peripheral can to you, the was by reason we T-cell cells. potential opportunity So as the this a the science a did And well, behind chance tell the T-cell Tom ducts. it's and the good remember, we of and I to the tell this disease assess for magnitude mean, you liver from the analyzing alluded to peripheral deal study because question. what recall, can T a I confined that's as this bile clinical a is overlook

So we support CNP, of believe evidence which completed which impact the mechanistic really showed rationale T-cell for early progression. responses, the which could assessment disease potentially we

effect we very unblinded a it's see on T to this which was determine cells. if small But review, could

encouraged endpoints. in that remember for We findings. a by data do the to to look So better favorable what looking these changes as the endpoint well that, the really to T understand early as on as clinical set Phase and well need reminder, while has the cells mean we're and II phos as the safety alk peripheral by primary tolerability forward

Operator

Our line Sandler. Piper is David with next of from Amsellem the question

David Amsellem

us that and of the Number remind this of Gattex on number So Can number of patient that stoma your you through patients or cycled patients couple one. of if That's approximate is, the on the questions number to what's what relative patient time size a have CIC just footprint have the subgroup subgroup. two are patients, just had of the the is it. of apraglutide. you commercially-oriented estimate over

That's And of generic on the pricing apraglutide lastly, latest a number about of are two. then thinking Gattex how to just extent that you thoughts materializes?

Sravan Emany

All right.

I think me So check on on start and I'll this. you Mike, one then the first can

between rough that CIC is patients. XX,XXX market essentially Our market is now are estimates and right size XX-XX patients. patients overall -- is globally the The stoma

it's and -- so X And XX-XX the between subsets. roughly

the I to and checked, is this treated, that respect on Number think X,XXX the patients been is treated our of our to information, in have be two, all this -- that U.S. with public and the understanding Gattex footprint patient about number I it's again, is Gattex. think by patients

And so that's that we have. the number

then David, on And third, pricing.

question. I this think already answered Tom

going months. that of then the package think going I I don't has is few a package But that compelling hopefully, come the idea top the our a we data think generics I -- of will Gattex in we're think there. data to a that's being And to to market we're a interesting in We'll to here, generic, viable on we'll respect really out find a bring a quite to view something see compelling with be of the already the competitive. here. hopefully, idea have With that, number generic, and very and out that

only get from disease population, is state, there from in one. for of a patient the in not volume price reduction Just United in you isn't States. X,XXX or heavily patients massive Gattex we a It's managed. And think much an having can asset not treated there's to this that see as lot

Thomas McCourt

to generic. that there's see program, cetera. obviously, probability to And you're we Certainly, really acted And there's but real [indiscernible], et a not nobody I also -- going an probably it's maintain our been a that high it. premise we'll has feel have on think

a and and be mechanics launch is support -- this generic a So lot able of to the generic. there's to

do think broader injection a population, patient fact to really the year, I I help within to having I on once-a-week that at about particularly the CIC So and drug a patients move a look it drug. and think first of speaks I therapy more could you and potent discontinued limitations And certainly the daily from the that XX% -- think like patients. drug when the think of that's injections longer-acting Gattex

Operator

next line the Our Cowen. is TD from Boris question of with Peaker

Boris Peaker

A of questions for couple me.

will data. you T-cell apraglutide just XXX T-cell data? to data? aren't ask curious when become is at First, maybe patients showed we why is disclosing glepaglutide Zealand's And of terms of the way on actual just kind see the we nutrition. how parenteral if it another curious then the they Or on that important of apraglutide assessing of XX% a I'm look in independent the

Sravan Emany

Boris, Yes. your Thanks for questions.

I any this completion take I and Mike color. obviously think event. additional contemplated On ever XXXX our out before trial we again, -- being a question, and run don't always then read we've think the I'll plan to we first is it to add always that results,

at able the if this I think in in complete more else... see for XXXX we data that's of to trial. able think think the set Mike, a say I don't point endpoint. when know we'll readout third there's you'll have be that to anything a around we're time, the primary quarter And I

Michael Shetzline

No.

I think fair. it's

Sravan Emany

then second take the do All right. you the second want to one? And question,

Michael Shetzline

Yes.

So enteral be higher have as our achieved for percentage question, in meeting have the I published. well. at that seen data program good the that achieved to small you it's it's that's autonomy And had open-label enteral Nutrition study. the nutrition glepaglutide we from the UEG STARS mean in study CLEPA presentation a nonetheless, the in autonomy But autonomy enteral XX% in public Clearly, was domain. on question. the there the has may a a to

So III we we're define data patient in better have STAR those study. for the Phase just the looking outcomes forward populations to to the

Operator

Capital with you Thank question your question. Instructions] of the next Tim for line [Operator One. from is Chiang Our

Timothy Chiang

XXXX, guys LINZESS Obviously, the on of of think almost guidance how for I do at But sort to at is at point? for well growth year. beginning year? some wanted quite with how of LINZESS doing LINZESS. you obviously get thoughts you're done sort you we're this still rates next next Since probably in, with situated you'll look your provide

Sravan Emany

you. to Good Tim. talk to Thanks,

right The of we've already, in now we're we're is performance as about and just high great think the LINZESS demand of still that excited we've growth had drug XXXX. a driving I growth volume the single-digit fact the in outcome. said year XX

we so to a untreated there of growing think be patients a lot And in that continue market. are

we're I at appropriate we'll did. which early think So in about guidance guidance, give that. the excited next time, part, With to always is future we respect year the like

Thomas McCourt

Yes.

I is think, Well, probably growth. been the time. we've XX% remarkable last this indicator it's most years, certainly, really has here best been. the a important how Tim, growth XX%, is And has lead most patients. new-to-brand this which Tom. We're of year over the a year-over-year probably than is seen in -- steady year-over-year, volume X predictor in And actually what's long the been stronger future at increase the always increase the

So for we're for up certainly year. XX% number signing not increased next a

what that need growth But And investing there. very -- we opportunity. understand bright, really seeing indication. it's kind pediatric how And we're confident some certainly, very, should There's see and assessing really be certainly, think much question strong. But looking next no we're of the from in look I the very we we're in year. still growth things to we'll think I upside

Timothy Chiang

is all impact? seen GLP-Xs, Obviously, to drugs. questions we the just any you LINZESS any drugs get weight loss? Maybe mean, I about GLP-X these a about one impact weight from of lot follow-up. loss the there for Have

Sravan Emany

take of kind this? you Mike, do want And to

Michael Shetzline

are obese as mean know, it's fair side. yes, regularly, you I on heavily our definitely do on mean patients too. true we as because well get being and also a I it's mean, that from also questions And used. suffer quite I constipation question, the Yes. it GLP-Xs

want actual mean so be a impact, some but hard to certainly at, really we're I but there. right that things present question. may And lot the now get a nail into concomitant use. you don't we to direction is really we there at to So that. have looking it, it's how impact of the that There down appreciate to

Operator

Investor QX today's and for your that conclude XXXX all will Pharmaceuticals Thank you Thank ladies And for Update gentlemen, question. Call. Conference joining. Ironwood you

You may now disconnect.

Ironwood Pharmaceuticals (IRWD) 9 Nov 232023 Q3 Earnings call transcript