Earnings call transcript Q1 2023

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Operator

Good day, and welcome to the Ironwood Pharmaceuticals Q1 2023 Investor Update Conference Call. Today's call is being recorded [Operator Instructions].

I will now turn the call over to Matt Roache, Director of Investor Relations. Please go ahead.

Matt Roache

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

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

will results Chief includes Officer, update review our provide today's will commercial During Medical Today's our our and review our performance Shetzline, call, Chief guidance. webcast Tom Sravan McCourt, on Emany, the an our Officer, LINZESS. will priorities and pipeline our financial slides. strategic Financial CEO, of and Mike discuss

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

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

Tom McCourt

this everyone Matt. today. for morning. first and results quarter I'm delighted Thanks, us to announce our morning, joining Good thanks

patients. flow. to robust demand and At we're strong I the the off cash the our taking of as of redefining treatment the that diseases profits a in another progress across quarter delivering and by first Company GI progress the year the in the believe care growth, for advancing Healthcare committed remain quarter to studies steps U.S. demonstrate terrific to to LINZESS demonstrated become and are we've GI the start GI leading Ironwood, made standard of we We continued of clinical organization

strategic begin with Let's on Slide X our priorities.

LINZESS including remarkable growth to Our indication with growth brand In and growth, experience and six strategy approved. constipation. the growth to remains XX the practitioners potential increased LINZESS adoption if sales quarter for a demand opportunity IBS-C quarter, XX% believe and idiopathic with to there's to reach widespread year-over-year. that drive functional a of treatment amongst compared for patients prescription net starts continues for Prescription additional the years XXXX, over of X% prescription of linaclotide in branded leading chronic momentum still LINZESS. U.S. significant maximizing We new demonstrating age, as prescription demand strong. healthcare appropriate midyear adults constipation first first a the demand as patients increased

data. year data from of the the the half response early timing which to disease-modifying continuing and in innovative starting a GI second assessing primary inform CNP-XXX, with progress the expect treatment T-cell strengthen on of are Next, ongoing we potentially The will and to cholangitis. focused continue we is study patients in the biliary studies, our the clinical line enrolled for portfolio top

Second, IW-XXXX.

with are study We patients syndrome. continuing and in proof-of-concept cystitis pain bladder the interstitial

Ironwood's we our in strengthen accessible actively portfolio. attractive expertise could Finally, in and market we to evaluate capabilities continue GI. And opportunities the opportunities are several from that we see to believe and benefit

quarter million cash and generate delivering an net of income for profile with strong the million GAAP and in adjusted innovative and as to $XXX is strategic sustained believe profitable $XX create first million with third and sheet. the GI profits growth $XX balance, balance portfolio company cash flow. positioned equivalents the EBITDA on and LINZESS company. build unique delivered priority cash and Our our next We cash biopharma ended a GI-focused a With we're the we horizon and to maximize well growth growing continue to respectively

Now let's performance Slide of X. the turn to on LINZESS

Slide left see As you exceptionally on quarter. can in well performed the of side X, first the LINZESS

X% a year-over-year in As quarter. prescription demand $XXX year-over-year million sales net increased ago, moments LINZESS I the and few mentioned XX% and generated increased

class-leading for Over adults that strengthen as brand the with should commercial the and prescription to are all-time actively chronic expect functional the treatment in constipation patients. prescribed constipation demand the And reinforcing FDA been have had growth an approve number access, the with brand. the is Most that see. million recommendations high momentum and dynamics, volume experienced driving treated experiencing for and the expressed first proud seeking GI in IBS-C of guideline execution and of treated we we position patients importantly, adult to believe brand constipation. societies to one satisfaction its clinicians this the combined momentum strong the with over both ago. be to number XX IBS-C since is have augmented patient X.X indication, than the the LINZESS clinical The to market new years patients both these quarter, we are market brand with strong formulary more launch LINZESS by growing the market of care continue growth high and evidence We from unique potential chronic the midyear pediatric

be of about we program our we advance the excited position financial advancing clinical In as growth where an our of we'll therapies, data clinical abstracts stronger abstracts of five These GI. Ironwood's Digestive the constipation Week to to including we're leadership that have a an few presenting in year, including adolescents. new days, the presence DDW, forward advancement continued linaclotide of linaclotide. treat expanding each functional ahead, and demonstrating utility presentation. in potential reinforce GI meeting and look to Looking highlight LINZESS, oral will or our important children We DDW, at the the Disease commitment

handing it pipeline thank a as is today. leadership to big the Before to the helping moment contributions over Chief for to I'd company last very for XX our programs, to and to Mike events take the Jason like most his Operating serving Ironwood to you say Rickard and make Ironwood discuss Officer a recently it years, over

While not like easy. this a change is

also through to committed current value, meet align and maximizing our next continue to our ways look resources to remarkable Ironwood As and all needs our Ironwood strong and the have we strategic who acknowledge to continued lives. an growth. to I we the to momentum would like organization as employees help functions of future and patients' and a impact team streamline priorities for shareholder to continue make key its phase execution support against

like the Mike. to to hand I over Mike? call now would

Mike Shetzline

morning, Good Tom. everyone. Thanks,

treat the better that's make begin the sNDA pediatric United States. only to adolescents FDA, pipeline therapy constipation could programs. this if as We expand our the market And options. Slide children pediatric approved, of million LINZESS continue population across X to and patient We would for in linaclotide believe potential a with is progress six three by the our on opportunity, I'll X. approved to our is first affects roughly program the population. this in need functional and therapeutic LINZESS prescription be If XX-year-old

FDA with through to date. forward continue PDUFA the We June sNDA work look XX to the and the

DDW and As at this pediatric group on mentioned, of treating efficacy patient data functional meeting. presenting Tom in linaclotide upcoming the be we'll the safety in profile constipation

United for CNP-XXX potential this is half in This is the line primary cholangitis, the the ongoing inform and timing will estimated Next to an plan which study CNP-XXX T-cell 'XX. biliary treatment The the and of data we those assess with potential science of given States. in affects the proof-of-concept XXX,XXX therapy, strong people exercise. of patients top responses option the in second underlying

the an at provide expect time. that We to program on update

interstitial We're forefront Phase need and CNP-XXX the very in executing I'll very therapies dosed II We're the to We're study. medical IW-XXXX, ongoing a over activations destruction to being humans, condition syndrome. if significant as or as and chronic as hypothesis Americans root this potentially there continues volunteers in as excited is Ironwood will cystitis crosstalk address this syndrome for patients is for no of it cystitis about we this bladder treatment the we're respect the the development. be program truly and game-changing bladder proof-of-concept With cause currently asset options wholly market in today first the area advance. be updates owned the successfully PBC of new are turn introduces in completed well. clinical are Last and the few excited time going about Interstitial are proud year, the looking duct of Sravan. and is dosing healthy the and are on screened, pain autoimmune patients to at that, site in to of With treatment tested there this are potential to this area. unmet development it millions a bile precision forward providing and medicine study because PBC. call There that of in market affects our pain asset on that currently

Sravan Emany

start which begin good and on position to year. the financial in to with all of It great be discuss an to is everyone. performance with off morning, is update Mike impressive will Thanks, I to LINZESS, such wonderful a you. an

shown an sales the of $XXX by on prescription quarter were U.S. to increase XXXX of XX% net of growth X% XXXX, driven As in million first Slide quarter demand XX, year-over-year. compared of the first strong

and the start to We are the the strong year of excited the continued about momentum brand.

brand to the were the XXXX. XXXX LINZESS compared XX% first profitability. Commercial to of of first in in Turning quarter quarter margins XX%

of $XXX expense, $XX revenues. million majority GAAP U.S. noncash. was XXXX, million of revenues of adjusted and was LINZESS income net in quarter. income Ironwood revenues million first the Ironwood collaboration $XX by million. $XXX tax Moving In to primarily quarter was of first which were EBITDA driven the recorded the million, Ironwood $XX

generated first Next, We our maximizing In strengthen cash $XX our assets differentiated from cash cash we we LINZESS and growth in by are success to company for flow future portfolio. believe ended $XXX positioning innovative and the GI equivalents. operations million the million actively highly with in cash capital pursuing allocation. and quarter, and quarter

that to focused investing and patients to our we opportunities approach and continue over to identifying capital value on believe remain long the balanced and in our while create the for a deployment shareholders potential term. We take and disciplined

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

year encouraged We the the and strong metrics. all by XXXX reiterate to are full year our start across guidance

of continue U.S. X% expect X%, prescription We by sales high net demand growth. single-digit and to percent between growth LINZESS driven

maintain access. payer In expect class our leading addition, to we

IW-XXXX. and and indication. million investment we momentum million CNP-XXX We functional to with $XXX EBITDA Ironwood strong year To of the includes to our had up, potential which and the expect greater expect wrap increased midyear adjusted revenue start a on between to than $XXX pediatric pipeline constipation advance of $XXX and million, programs build

quarter first GI continued sustained priorities. continued maximizing and against is and our remain strategic LINZESS, We flow. growth profits focused reflect innovative progressing -- our and results for generating we remain and strengthening we positioned execution free believe well on Our delivering Ironwood portfolio cash

We supporting I are progress. now our questions. continue close therapies year line ahead to Operator, we'll the open all GI dedication on thanking keep may what's and you this shared for disorders. advancing about to caregivers their our and and for by want employees, excited advocates patients, to for of you updated

Operator

comes Tim Capital [Operator first Your question Instructions] Chiang from with One.

Tim Chiang

demand little year growth bit of could of trends well. additional How Obviously, how a about out indication. talk just playing going for bit you see talk like to for a about the you're constipation with little looks LINZESS do indication just quite rest And a see are LINZESS? get obviously, sort you longer? the functional could you you'll think much pediatric it you doing the that Tom,

Tom McCourt

we're quite the continuing we're Well, this -- excited year. to in seeing of see half quarter And hear what demand growth I moving the think forward. about you first we're can first this

year. more -- going really data points how a we're of we land we'll we to the think to need understand see couple think I

firm reason or will month the the guidance. good kind think we're it's of on next I But idea. our us a why staying So current really give so

the market in back you market seeing accelerate we are right we're now. little disproportionately and in mean, of growth know, the As that that tends the year. slow then seeing and market. we're not But I bit this to capturing grow growing down a half the summer

plan some in We've physician with augment we're ad AbbVie, a place our adjustments for think seen interesting. made seeing. healthy the is to the call to be So growth well we're of growth think I very, It's this that spike as coinciding helping we very seems the which new brand. as some with DTC we

about the very we're think pediatric population. optimistic I

out are X suffering. Mike million X there there kids to million As said, are that

next market kids I very see help. We're care, can we're probably going disabled population we're talking have series be AbbVie, with And be pediatric assess to to is, which here, to which doctor pilots a the we'll for really big adults think to and really to is are year. inform certainly fact constipation, how what of we promotionally different to very symptoms and the Tim, partner, a really we're times actively will allocate seeking that's thoughtful here, the to running do if adult than you will -- how trying these a the But investment about this opportunity try going investment to going responsive our that abdominal the where and with struggle is you're which self-medicate. kid multiple

So out Tim, of market. a see this whole growth, we're I with performance we lot I coming market. 'XX at hope 'XX and and the -- in invest But come invest point of growth in this we think really but impact know time, as don't will in drug. see focus that delighted this will of we'll the I real the

Tim Chiang

And maybe in do of you sort question you CNP-XXX. talked What about on see T-cell just to threshold this need study? Mike, II Phase response. one

Mike Shetzline

this why a an is one by looking because you work actually technology to reasons at the we did study and we so we It's as feel so this to going we're in science the T-cell the have strong with a PBC, deal is So understand we responses. the how really think -- know, first-in-human do this of learn lot. drug may opportunity

nanoparticles recall with a like may the inside responses they study, response, You gluten or that also T-cell with pretty in treatment robust using gliadin back the T-cell XX%. had reduced meaning roughly celiac

but histology is improvement. So correlates that's necessarily and not robust. epithelial reduction, as it that T-cell correlated with was pretty the a actually But key well the biomarkers celiac, point in with it

out but longer-term really responses. remain the So downstream for to think whether the of the play correlation gauge biomarkers benefit, at read a the really the about and we're but There's opportunity clear we're do can to function just be T-cell going the in the to by in really drug have to business is at to opportunity seen, going think that's at the because T-cell going The to to work to where the responses excited look for early understand strong. is we we're on further get terms liver with absolute that. terms going early look will and to a of we look so T-cell the percent clinical great case we responses to investment science make an really

Tom McCourt

drugs relevant an far and as respond. you if that which as probably And the at most look FDA Mike, as maybe comment also how are endpoint biomarkers on does

Mike Shetzline

of are acid. because regulatory ursodeoxycholic pretty of obeticholic prior biomarkers The engagement fairly acid and established because

those -- a stopped of Alk phos, primary delayed programs, alk flow not are the unreasonable. liver what and these or and or indicator phos the agency bile focused really in is So that's which bile on diseases which cholestasis, that about is flow. delayed stopped is

think in strong well. the as there is real the this too bilirubin there. reason biopsy like a standard and the of may but alk biopsy because a recall to is we needed study. we're that early clearly and that's works other technology we that have agency the why position great powerful for assessment as is and because acid assessments, also working the importantly, liver improved So And mechanism and And drug other have in that's very there things is assessment biomarkers such the we be objective the an liver you type really But strong well. that the evidence, read necessarily the way to of make how like biopsy the also objective T-cells we development. transaminases the biopsy in will wants with the a not is function where able really to be the T-cells in with obeticholic really sort on evidence agency phos quite get objective plays, then biomarker-driven drug And uses why programs a that's is strong because biopsy the and that's correlate another today. And drug sure to do the because underlying for function then

Operator

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

Unidentified Analyst

and how the physician to to force Can expand for count This Skyler audience you the pediatric potential David. about head opportunity. the thinking support you're opportunity this for remind us need sales target is on

Tom McCourt

earlier, won't prescriber be point, any this As news the increase of series a I generate be there selling There effort. X,XXX will XX% to -- like concentrated any we're is in We're base, good to of going X,XXX mentioned this to pilots. running really docs is at fairly volume. a won't XX% -- be the here

can we off lower So data our those the really decision we'll of lower -- let those existing one. into easily or fold and kind this less busy docs guide list positions. on trade for performing call our And

point, significant of fairly we business. do So to increase take go majority think look we plan. generate currently then the effort. Keep see calling who in out and a XX,XXX physicians there, we're need if that's we selling our at mind, not response At some this about the back we'll the

really we will the come the So to which patient we with effort, affect this good advertising number a direct-to-consumer and to hard we sight do continue really look increase come of promotional selling line to it not we as with to isn't the how direct need and think regard in make but both targets, of but significant us overall programs. personal our I'll a -- push mix, only to and promotion refine and balance back at then we'll give

Operator

from question the Peaker Your of with Boris Cowen. line next comes

Boris Peaker

CNP-XXX, just ultimately, guess talked clinical about, I this approval for of can indication you in a an or I to like these on some have outcome? with for based just approval, clarify would do actual study you get want an you to biomarkers

Mike Shetzline

obeticholic addressed of the they that That based or been class has improvement got acid of history in phos. alk ursodeoxycholic biomarker of acid has also with with prior that on approval historic compounds. kind So Urso because

usually in the been it another on happened market. to like get but done with So because setting They they're post-marketing liver the requirement do a study acid the has case. those that obeticholic in clearly has And a improve benefit agents, cholestasis. they that's study,

do actually do better and good and should with cause also we patients the they're that's them, evident the be alk address products, a to and in disease but phos alk they don't be for in they like the responder don't but root on acid obeticholic So of a CNP-XXX, because phos the what responder programs. to those is is have biomarker, you normalize

have to potentially You that phos degree. normal, or of is XX% alk means or can to liver actually get function XX% which elevated roughly because your abnormal you X.Xx your X.XXx still

longer alk response early the success around has agreements. the post-mark agency phos a think, does the we good I opportunity come T-cell because So objectivity getting that, like for term. on been real an why gives accepted that's with marker into a more us by usually read the insight for and And

Tom McCourt

to endpoint that normal. a is that's to level Clear, actual phos reduce responder The alk Mike. X.Xx

Mike Shetzline

Correct. Right.

Tom McCourt

Okay.

Boris Peaker

care? really an standard get control, could you study, for placebo space in use on the ultimate it's have since or to an control this of you'd a you And think active do approved pivotal

Mike Shetzline

Yes.

date discussions. Phase we what certainly, agency design like. data get with I to have We we on those now as care that Urso as don't we would Again, have any an opportunity have as placebo-controlled But granted the can for there's think we'll look obeticholic anticipate that, we'll to discussions do acid. standard take the failures as well of soon will. Urso III

being we nonresponders. Urso the Currently, study and to Obviously, to treated. keep patients So we is we're need want designing that. manage for

of of to is an have that another really obeticholic acid using there we But they because do benefit Urso therapy. we responder that's So there. still get alk unique an even this an when feature in again, and this or cross responder, think the phos still asset setting bridge often have I abnormal

to to So who standard show a being a the used. sense, still are included, we agents an of that benefit first? other patients think have opportunity we Does care may in even make not be responder

Operator

with Your comes Hughes next question Fargo Wells Jacob Securities. from

Jacob Hughes

A couple of questions.

three. you're benefit Could On the you dynamic? headwind there first I because dynamics I about was growth think think last of if the rest guys any year of year, benefit because year, you quarter, in implied just the talk last for a pricing quarter down that that the the seeing it in the the similar had one-time in was is

Sravan Emany

one-time a anticipated. in implied of and single had guidance we're -- net this of about we mid-single digits you performed a But sort where in kind low the expectations XX% pleased that, the to everything where really I for essentially good and with really I full by think is -- said see year year. in terms ended benefit. into contracting price. today. where we by price line to course for of we -- as we pretty We'll This the the comes into year. that where of pleased demand a segment. growth we to else I would really is similar out. line. quarter would for start with sorry, of digits over a of the Yes, aligned was year. look, it are are price is set about got our better say terms sight and saying would not the I'm sales quarter This rest of But which little year, for what of kind I It's prescription last say good the full have of than start price X% driven the price because sort we of is up potentially

Jacob Hughes

from Pricing the first on same second the bit the our the like far scripts better okay, quarter look standpoint, quarter. weekly a is little demand little in is then so the about guidance, a better. bit like And

in is indication. So much year in Is the anything the of of that terms the only there for the half after you're I it's constipation of how some know much And then -- guidance? the that's the in back pause one quarter in how there pediatric like, second seeing the as giving you back. functional well?

Sravan Emany

yes, quarter look, back at And throughout trying transient. before think I excited change the me look, from let But And on to want give momentum we're come the So year. we little so you pleased doesn't really where piece, X have first about saying, I'd are finer just bit the think year. see start make by to a data in we're we this was can see I I we am and fluctuate going to quarter. the you a look point, price any guidance the all. put in to it we I with more

you if we'll this was you think to give able XXXX. a And than sense. of the back I experienced moderate to itself, quarter sustains in First course be we and come more better

and Our any always does guidance contribution contemplated pediatrics. from has

So where are. happy look, think with we're I we really

give LINZESS call, heard back in if I the you you to and And continue like an have you've come update it second think this, that. may quarter something then we to you the we to here to performance see on excitements tell on we performance.

Tom McCourt

of regard with pilots upside response I the these this the one we're reason think other. to we're is think this really see again, this cautiously more a lot the quarter running And why, to pediatrics. group why we're because the -- regard have end see year and to we're being of I we're kind this or the careful is. understand going is we'll third think the we'll a what information with response, And we promotional quick how by way optimistic a of little to

think sight. have we'll of pretty a good line I

off-label end it be real this tuned see be I asset practice kids, like in quite are be I to that's category a learned And the this updated also kids. mentioned. up actively clinical thing market, care, We these real approved drug actually certainly as end following this pediatricians drugs this And we functional guidelines drug is the the a is could the new approved where and that's think only indication. care. constipation. and seeking one one But standard kids prescribing think we've keep these -- as advantage. physicians up I market we'll a as for of will in the launch for pediatricians don't we to as for think far traditionally, have But because what you stay one,

Operator

no questions, for With we Thank participation. today's conclude your conference. you further will

may now disconnect. You

Ironwood Pharmaceuticals (IRWD) 4 May 232023 Q1 Earnings call transcript