IRWD - Earnings call transcript Q3 2024 | Ironwood Pharmaceuticals, Inc.

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Operator

Thank you for standing by. My name is Louella, and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals Q3 2024 Investor Update Conference Call. [Operator Instructions] I would now like to turn the call over to Matt Roache, Director of Investor Relations. Please go ahead.

Matt Roache

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

Our this release press issued our found website. on morning can be

the Factors safe results Securities Risk December and heading available our the and in such under of the as well this risks XXXX. these and for forward-looking and ended call accompanying statements as may include risk harbor on date report materially. involve year statements our All Today's presentation, update on XX-K cause statements. of A that actual we XX, in of Form speak filings. slides Such slide statements annual is and the as differ the Reform Litigation undertake statements within of to Private statement uncertainties subsequent no Act to current the of factors SEC XXXX, forward-looking meaning discussion obligation

which supplement to a considered non-GAAP comparable the are be for directly only end should tables included To at measures. measures GAAP for measures. a as please substitute press these the extent the to the financial refer Also reconciliations release our GAAP applicable, most to not and or measures, of to of superior

pipeline. Financial our the McCourt, and Sravan today's and call, results our will review commercial a begin Emany, with overview Officer Executive During Tom our will Operating Chief and of Mike And Chief Officer, our Shetzline, discuss Medical guidance. will Officer, LINZESS. brief Chief performance the discuss Officer, financial our Chief

webcast slides. includes Today's

the accompanying section please to Events access our dialing of website in, you of separately. to those go for So slides the

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

Thomas McCourt

today updates. and our thanks Thanks, financial quarter review Matt. to results third and Good for joining XXXX everyone, us business morning,

XX%. by remains as double-digit continues both consecutive with by option driven the demand robust which XX%, marks prescription volume for to in increased demand growth. growth providers. the LINZESS In new-to-brand Starting patients treatment also quarter prescription by grew part of the This prescriptions, seventh and third quarter, new-to-brand LINZESS year-over-year preferred LINZESS. deliver

pricing continuing in Medicaid is prescriptions While the prescription strong, last experience volumes primarily highlighted remain overall to LINZESS due we the LINZESS call. to percent quarter's headwinds as of a business, as on very increase

pipeline. Moving to our

working submission label past adult syndrome NDA in several who to been with with we've dependent support on apraglutide quarter a short the patients complete focused and filing months, track towards an XXXX. of are our on on parenteral the first remain Over bowel

need experts from in bowel we're the short apraglutide's short adult and bowel continue syndrome, syndrome We our that dependent choice in Feedback on and support syndrome physicians treat about market among who with be if short approved, drug of will bowel are unmet III syndrome excited patients. to our data Phase parenteral to short support support. to belief apraglutide the patients significant bowel from see opportunity potential

very proud had Last of and was new our quality Annual the our III College which presenting where of recipient American Presidential And week, privilege the oral of data. STARS shared of interest we're Gastroenterology subgroup speaks presentation, STARS Scientific the an abstract was we Phase safety Award. as in the analysis of findings Poster to ACG's the and at Meeting, the

dosing STARS demonstrated previously efficacy, discuss III its These and including our convenience. reinforce Phase detail, on more profile, data trial clinical Mike from announced findings, positive strong the in which build apraglutide's pivotal tolerability will once-weekly and

as to forward look and apraglutide updates as soon Our more the to months ahead. we focused possible, on to team progress providing in market is our getting

not To our license an and made evaluate drive reward routinely Moving to investments CNP-XXX. exclusive the acquire we this value option the seek exercise prioritize risk pipeline programs. of We to decision and most our believe term. those to which our to we long to end,

deliver study further and which will in recruitment made we'll assessment, a also decision bladder efficacy syndrome. we follow program. anticipated XX-week we the inform II maximizing of XXXX steps value, These can pain where end the for including profits study most our LINZESS proof-of-concept allow business to interstitial on in the launch cash full current the cystitis decisions efforts apraglutide us expected population to the Phase next flow. And and the we in And believe focus IW-XXXX on and on

and EBITDA. the cash reiterating delivering third our quarter Moving to the full flow strategic performance, third million of we guidance. operating XXXX $XX and our adjusted quarter, third In delivered priority: million Based profits sustained on cash generated we $XX are year financial flow. in

sheet, we credit to credit the our of facility outstanding million $XX facility. on In strengthen principal balance revolving and addition, our repaid amended balance we our

a good position continued priorities a support structure we and generation believe flow perspective, in execution with a pricing even LINZESS with of years. we capital are to strategic LINZESS financial coming From over cash continued for our the meaningful pressure,

intently apraglutide toward are we flow profits launch. commercial submission focused on pressures simultaneously while advancing ahead, NDA Looking an pricing to cash and managing and LINZESS maximize

net take let's of some Slide quarter, to a million. moment commercial performance details at LINZESS on $XXX on were third Now the sales U.S. additional the LINZESS In X. look

prescription growing As providers in XXXX, LINZESS third XX% that health and quarter earlier, respectively, in the to rose extended I patients a LINZESS market. quarter, mentioned compared continue reinforcing to third care of units each and new-to-brand the by choose

of state-by-state such combination the than due increase factors to The Medicaid headwinds a Medicaid repeal, offset market driven and redetermination strong legislative business, was as of by percent the AMP more as continued and cap by primarily our changes. volume growth in pricing a

since first at remain quarter a levels. we current That as this our Medicare stable business of said, of the the have year, seen relatively percent

continue as redesign legislative LINZESS. D potential its such the utilization and We changes additional impact Part Medicaid Medicare on and closely XXXX to monitor

on flow demand remain beginning of and guidance expectation to pricing on to focused seek XXXX forward LINZESS optimizing providing profits cash the look pricing maximizing LINZESS and investments we year. We pressures. brand as the at We and increased mitigate the additional the

pipeline. our to to Mike discuss I'll hand Mike? that, With it over

Michael Shetzline

for support. are parenteral on I'll good syndrome and morning, patients apraglutide Tom, who short Thanks, start dependent with bowel everyone. with

last at meeting. from mentioned, new presented findings of Phase of analysis week, the ACG Tom endpoint we primary the a subgroup III the STARS As study

effects presented weight, the of as anatomy. results showed treatment race, across including remnant support. given are important consistent baseline demographics, positive SBS data with age, dependent of length These were such are region, characteristics additional patients of for parenteral The SBS the who on ethnicity bowel body adults and gender, heterogeneity apraglutide established

TEAE Phase In addition, meeting, Presidential on at SBS. and moving was STARS Poster to which in program in-depth any the an interest Award the The or safety those focused of special adverse treatment-emergent notably data analysis received the Slide ACG. presented from X. poster highlighting analysis A of tolerability III and the event

other signals the were Importantly, in as placebo in safety the detected apraglutide of which apraglutide been Of reactions were special analysis. no for site injection this and seen such similar arms. new hepatobiliary and with particular have TEAEs GI in neoplasms, were SBS GLP-Xs note which interest

the safety approved. of This further be this population characterize are to of bowel data meaningful on short profile These for parenteral on profile type in patients can support. patients with who of start apraglutide if therapy stay dependent syndrome and

regard complete expect first previous our of with the our on submission fully the track In we remain quarter NDA in to guidance XXXX. and to submission,

the in its trial safety, about the to convenience. and dosing and by once-weekly efficacy clinical continue be We tolerability excited demonstrated apraglutide

and believe with on who life the short for these have approval, help dependent quality improve factors parenteral are patients to and the Assuming we syndrome bowel adherence distinguishing of uptake potential support. drive

have Moving on recruitment this further of provide of end have to data to the of an IW-XXXX, an syndrome, we of wholly enrolled. the assessment, expect decided next to inform our we first of for for and to owned pain half treatment complete interstitial the an adequate update steps we potential us in set on sample asset cystitis/bladder believe currently analysis Based program to enrolled patients the XXXX. patients the

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

Sravan Emany

in the of million arrangements collaborative third Thanks, XX, third reflect by this I collaborative on revenue in estimate net as will AbbVie $XXX U.S. Ironwood September to sales Ironwood's reported Mike. $XX quarter. gross-to-net million the LINZESS recorded of begin quarter. were revenue positive $X.X million quarter, U.S. with Slide XX. reserves In arrangements With the collaboration third XXXX. adjustment adjustment, LINZESS was to Ironwood's revenue as

continue on and cash to changes Tom closely Medicaid monitor legislative trends focused other we LINZESS flows. and and As profits remain maximizing noted, utilization

sales Moving year-over-year XX% the quarter with Slide the year-to-date a XX. XXXX third basis, On U.S. quarter. were down XX% U.S. third compared year-to-date. in to LINZESS were down net of sales net

Ironwood in and third the million, year-over-year. decrease was $X was of XX% revenue quarter a income was GAAP million. $XX adjusted EBITDA $XX million, net

credit providing for capital evolve of our business. we million and with structure extending facility, us flexibility we XXXX, September, allowing to maturity our $XX our to continue December as amended the additional operate greater and In liquidity

ending will principal on We $XX portfolio, million cash flows quarter the quarter development $XX repaid we million equivalents. And million third potential with our the In of $XXX we revolving the support facility, our of cash balance the our outstanding on and cash repay quarter, credit with debt. our further drawn programs LINZESS to the ended progress facility. launch, existing including apraglutide also and third continue the believe

third we XX. continued our second including trends, Medicaid performance, in guidance to had XXXX full quarter. Slide the Moving our issued Based quarter utilization in we that on maintaining stabilization year are

offset million. $XXX million continue of revenue priority revenue line top net Disciplined we profits EBITDA of expect headwinds and optimize $XXX $XXX $XXX seek to We management a million million adjusted sales and flow. $XX between and to and than LINZESS as U.S. Ironwood between million, expense to remains cash greater

continues is market To the brand's robust, position demand to summarize, leadership LINZESS and growth strengthen.

now profits to and Our for focus demand is LINZESS maximize to the future growth and flow. cash goal

focus unmet clear to in clinical addition, needs. as In development market such on decisions to fulfill a to apraglutide making smart therapies we're with patient path

possible. advancing as such, we remain focused soon as As commercialization of and approval apraglutide towards on

parenteral further data also treatment new strong cycle lie not adult for profile, life The potential patients management the of ACG opportunities who at are but presented dependent of ahead. support, clinical the on significant that are only for apraglutide's SBS evidence

employees, to for by of close caregivers all our want therapies GI and supporting diseases. shared and advocates dedication I their patients, advancing for to thanking

open questions. line you Operator, up now for the may

Operator

Li first line [Operator Instructions] of Your question from the Amy Jefferies. comes with

Amy Li

commercial noticed We is this quarter-over-quarter. and pricing margin for forward expand some the of the see headwinds? up going LINZESS to X. help that Could we continue slightly Just offset

into you your from annual in the given eat LINZESS finally, the D wanted XXXX. expect WAC on then impact catastrophic LINZESS thoughts the to X,XXX? get latest is Part phase, do to And to How much actually around redesign

Sravan Emany

Yes. Thanks, Amy.

to just headwind in me do believe pricing by let start a we there's saying So going XXXX. be

We'll We year on guidance point. do. this guidance given XXXX next year specific the normally year full haven't in at we as provide earlier

has think earlier guidance we in a be we position year want can. kind this year. we'll good to of a best I gone sure the make we how from given give guidance Just possible perspective, And next

came is margins And the right look, With respect margins, brand will profits I -- manage, the to to as expenses as we're I we continue pleased where in track what commercial a can. the draw you're where the the seeing out the of quarter. year. for to brand think predictor But of be good think with much now, out we'll

Operator

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

David Amsellem

what taking net beyond just its net payers general. do as contracting for renegotiations into better the commercial Just a product get the improve on to to thinking fundamentally moves you In understand to couple. better towards can taking potential Just this Maybe for there at potential a there a back words, try looking trying year. economics? Is other such end the at -- with and different of in look is the the step life? LINZESS gross to that you contracting

number one. that's So

through two, associated commercial there's life, of spend sort just commercial where the that, help with you're understand longer mean, just managing term us as about margins, of the product not a for really XXXX this be LOE. Maybe you're is sort of such question, case that end profitability? regarding thinking I better then less a brand going the nears how And but to the LINZESS its number the

Thomas McCourt

Yes.

as the market the product It we to dominant even earlier, share where, player. where right very as I in -- a I profits critically So and very, really now to continued mentioned mean, place is at we're the cash we're point very, to where emerging we've now a competition. about And look think is marketplace, a how the strong I place or need in flow. in increase are, spite of gain where very I a we continue strong in think we at sorry, think we're some at going, point

we're investment So ongoing the as growth, is at that, the and at contracting, overall brand those. contracting as look looking balance we access I market look and I investment how do and in critically promotion part and the in all of question at

point margins and objective profitability. no to this There's the the increase the at question in time, is

effort everything to at bottom we looking to our push we're we really media contract line. we spend maximize in the how now, selling to can from what what right So and

will copay assistance. And look strategies really there's -- no things like and question, we'll -- we look other to to including we continue maximize contracting at that,

So with are increasing and now time really I start us think on cash all it's aligned those the and profits right AbbVie, to very looking of closely we're things working absolutely who say at is with to flow. table,

Operator

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

Jason Butler

share prescriber LOE, one in not LINZESS. the promotions you that's demand of -- but them, and and terms of the how but receiving of Just When to growth? drug. another do about you market being forward drivers I'm on like things depths the profile just I think of more thinking of breadth obviously, base look patient through And guess

Thomas McCourt

Tom. take Yes. It's I'll that.

X all disproportionate I doing market probably the and you're is market last the the years. about been this When we've pieces think share, that. and growing to that several leader, there's capturing for

right to market the But dynamics, momentum we're but the is a now at the presence extremely the with where of both brand. strong, regard also point

seeking the seen what people significantly there's couple care. over is years have past of So we more

the Obviously, to disease is, educating expanded for also appropriate right something far of who that deal is has -- been of by that campaigns the we with years of and in physicians patient who the physicians' the patient, spent significantly. is increased as adding a part that's of awareness appropriate and indications which view driven due also of DTC drug. that the pediatric patient great is course, And on time the as the

cycle -- with working and which really something forward, very want but kind the over in also move such to to way, because a be to understand a it we certainly, at and that drive we you which time other it's durable we're more as a over how continue horizon efficient far of -- looking know, large plays as demand, clearly happens we management want and tend life do as the to happens And to are that on OTC, we when is AbbVie very very market, is on brands counter. and a these it that

and and strong the continue we think think position continue LINZESS need I is that, to to carry a So in And I at think flow. focus to to think when momentum will the in it I grow. look I that I very on come, itself can cash really profits -- years and we

Jason Butler

then had Great. on apraglutide. And just I one

that continuing You're doing planned have the aspects coming maybe obviously talk readiness Can to work months the presenting meetings. during at data you the review? of for about focus other you're and for, commercial medical regulatory the now on

Thomas McCourt

There's -- do we how has do do and brand, call we last market, prepare knows. a X don't This prepare this know ongoing focus really months. you and X switch everybody Yes. the the the been prepare market, turn how organization. on for the how we go This as you to to on just on

are And label working already Mike in program as medical diligent of the there of prepare those about obviously, we very the and team what the things the towards forward, out disease is we we're short syndrome, moving his awareness best in And together limitations all market, therapies. bowel meetings we and with pulling what current are possible are can. including

to service to drug, is critical of is significant And a adherence and attractiveness things the the potential of both the only durability you those. months which And with it hub, to as that our as like we sharing And I first which its some apraglutide, that be also that to likely which patient we'll move strategy, keeping the go-to-market increases working we we'll core on each overall through really them the is the value forward, course, getting far not going also also drug, upcoming for then capabilities organization, treated. sharing in then, be but things with in create think as therapy, need team the we that's the of them the but and come. patients something choice of the in have to to particularly regard system, on drug with but complete on pulling be months the value regard the patient as work

Operator

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

Mohit Bansal

and -- took that million a have the is because guidance $XX like if that charge reversing. understand understand seems us is positive it like the like the impacting X, seems help Can not the a you lot I I of you you here, dynamic may. quarter, in first it is why help seems the us One impact? it can

regarding bump the of fourth I -- math, as dynamic profit, do expecting here? then you as share I it the the help Can that number fourth fourth not quarter, in the question second line us And would here the quarter you for the if like mean are LINZESS. top quarter, seems is out understand much decent play your a for

Sravan Emany

Yes.

So you second the repeat Mohit, that? question. understand don't Could necessarily I

Mohit Bansal

if I to at is for like million guidance, co-promotion for it profit. $XXX So $XXX look LINZESS, the -- million your it

in X You did about million months. so $XXX far

So in fourth a an like is there's it bump, seems quarter. inflection there

you doesn't understand the is help see -- what causing inflection? us can okay. So It

Sravan Emany

Yes.

cyclical, it's profit So the first has of other fourth And quarter tends historically been more have of the cyclical the right? all, Mohit, than brand to that quarters.

to second the question. So the answer that's

all to of the a this small look, of I course point these timing when question, the to seeing with respect will time. about was the out year. timing gross-to-net the in full first even they for just we've the at that's But is been adjustments over adjustments you're And taken. differences AbbVie. the and recording divergence tied With that, just there's question first say would

Operator

comes Davies line from question Intron next of Research. Health the Your with Natalya

Natalya Davies

the think into Just R&D how compared costs, should current we associated going cost on apra? a expect we about year? SG&A in XXXX the jump And prelaunch with should for to

Sravan Emany

Yes.

will for first all, buying we where give guidance. do could fact is I be when XXXX think infrastructure. we'll Part acquiring commercial that and and we guidance the give for rationale question. normally of an But profitability next apraglutide earlier, next as So we have guidance thanks that think of mentioned for year, year that just think, an on significant give the on take we'll existing as we force. the I launch And sales know we already a we have commercial we asset spend and we but

Operator

[Operator Instructions] Okay.

comes the line Partners. Your next question Leerink from of

Matthew Cowper

This Cowper is Matt on Faisal for Khurshid.

on Just start how if will this team not team apraglutide, and how well? current as And And you overlapping do the selling here? work sales -- prescriber like how or so, a Will force between the the apraglutide large of LINZESS need LINZESS is base? apraglutide? or

Thomas McCourt

Yes.

that is experienced there be overlap we I may table which LINZESS, continue well great and we different slightly is regard offices. job real with we fantastic And There to in a is of tenured it's the -- a know. to sales think where you with same do to bring have very largely the as strength this deal prescribers, force a offices. the They here gastroenterology. but

other that calling large than some is we academic such there a would far additions to disease, rare we're also Now fewer currently mind, this be as prescribers being on. keep this will in areas and focus. But centers that some

day into easily the I access very get our existing have running effort and and X. strong quickly apra selling very able fold strongly we to think of we be can So because from that up we feel

the table strengths I the and Ironwood one towering space. it of So in has this to real that brings think is

Operator

call. joining. at questions not you that do gentlemen, concludes more and today's all Ladies Thank for We this time. have any

disconnect. You may now

Ironwood Pharmaceuticals (IRWD) 7 Nov 242024 Q3 Earnings call transcript