IRWD - Earnings call transcript Q3 2021 | Ironwood Pharmaceuticals, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning. My name is Rob, and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals Third Quarter 2021 Investor Update Call. All lines have been placed on mute to prevent any background noise. After the speaker’s presentation, there will be a question-and-answer session. you. Thank Instructions] [Operator of you Director conference. begin Investor Roache, may Relations, your Matt

Matt Roache

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

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

on Jason Operating review will Mike that provide our COUR update McCourt, will we and wrap towards the our up an including Tom will financial announced performance strategic Rickard, During and CEO, of Officer, this results provide our with pipeline, a guidance. our and Chief commercial Officer, Shetzline, morning; with agreement on call, Chief our LINZESS. Pharmaceuticals update option priorities today's our Medical of an progress

We will the to slides webcast. referring be via

over please to that, to access will turn the of the go call For dialing Events the I those to section With slides. of in, Tom. you our website

Tom McCourt

Thanks, once strong today. and for driven that entering morning, demand thanks with review a in expanded by coming constipation. the symptoms us Matt. impact everyone, by American Gastroenterology few meeting. announced pipeline College our Pharmaceuticals, a joining closed LINZESS on we abdominal again This We prescription an agreement minutes. Good COUR XXXX, with option findings we year-over-year. survey have syndrome which We're detail with adult we another out more from in double-digit in in morning, quarter irritable into bowel terrific we'll where patients presented new of a of growth of

gave of treatment advance work patients. execution GI four presentation we oral team's Presidential more posters, in and proud be for the standard diseases and GI presented of an and other ACG's care of redefine one we're doing Poster the addition, I In which Award. received couldn't to

Let's strategic start our few as well as our imperatives with overview a priorities. strategic of

demand new-to-brand grew strategy a Our to In LINZESS adults LINZESS among treatment total quarter, XXXX, the third outpace XX% chronic in starts constipation. as prescription health market. continued prescription IBS-C launch and prescription leading with the practitioners the continues acceptance for with and to demand experience care growth Since year widespread maximizing quarter, LINZESS. and prior versus accelerated

on will bringing both to our organic are external development portfolio internal looking we innovative and providing assets that be through an Mike diseases. the an GI of Next, build pipeline. serious through target therapies update

opportunities equivalents our shareholders with and to always impressive and as bottom a bar effort had had. taking million explore We're quarter high return cash third thoughtful flow. on and approach delivering same an continue to growth disciplined maximize the to Finally, on the another and we've cash quarter line cash We capital with sheet. allocation in we're in balance we to the sustainable committed profits to $XXX the ended

discuss to Mike to over it turn Mike? our pipeline. will I Now

Mike Shetzline

conditions, Thanks, with advancing start good on FDA treatment morning, interstitial pain asset We're visceral our application to first for the Tom, pain IW-XXXX, development the the potential as IND the year wholly the in XXXX. of this We're owned and and of clinical pipeline and track quarter endometriosis. the through program of such our of everyone. cystitis, syndrome the

to We're announce to if the entered addition commercialize to we're we that believe, CNP-XXX, potential an In IW-XXXX, into option exclusive in successful, COUR have excited acquire the agreement U.S. to an we which with to call. and to on license biliary biodegradable which pipeline, liver, primary in in a may which Jason liver expects affects fatigue provide clinical rare the a of disease treatment as novel significant We will PDC-EX, a PBC, the in We believe is commercial approach pruritus U.S. the to ultimately has as an autoantigen COUR's CNP-XXX need autoimmune that targeting known in requiring for in potential nanoparticle XXX,XXX the the the cholangitis, COUR encapsulating CNP-XXX. with responsible the the our state-of-the-art paradigm treatment and result transform with as lead profound can pharmaceutical estimated be COUR's innovation uses first otherwise with of people this our as platform the shift an the other via irreversible no PBC. of immune trial bile COUR, with potentially new on begin autoimmune be gastroenterologists and immune the reach expertise as therapy disease-modifying for of introduce deep advancing and more treatment biliary damage root well game-changing options. be scarring Ironwood's through well PDC-EX to has of thrilled destruction uncommonly, primary forward bile new presents GI demonstrating relationship eliminate the Currently, to and later a for collaborating proprietary that of move settings, patients addresses nanoparticles to year. present to like pathology clinical for expansion disease destruction opportunity shown proof not agreement the to potentially with Collaborating cause of combines detail area therapy cell CNP-XXX the help platform PBC, in to PBC. to preclinical and us and further in liver of COUR's COUR's PBC. opportunities platform treat technology can strength believed tolerize allows symptoms which differentiated autoimmune leveraging strategy and, duct the our system immune to in the opportunity ducts the to the in and transplant. the an is development there therapy the believe cholangitis. reprogramming PBC opportunity our develop

forward, our pipeline new as development to Going continue share we'll updates progresses.

performance back Now discuss LINZESS. of Tom to commercial the to

Tom McCourt

by patients and deliver its constipation. performance new as refill strong to for in continues remarkably quarter, further the IBS-C of reinforcing in chronic U.S. volume, LINZESS Mike. treatment Thanks, a adults powered and prescribed position with the medicine the #X third both the

with the of to strategy mentioned execution $X in fueled few the the that LINZESS our U.S. grew near sales potential strong believe earlier, drivers. of As sales exceed LINZESS XX% that sustainable prescription net result we're our resulting This U.S. year-over-year, to a net We confidence in of LINZESS $XXX future. has I billion demand growth commercial continues performance the demand reaffirms be seeing strong impressive and million. by in

for constipation LINZESS overall patients, burdened key bloating, are and plus abdominal a First, pain by our symptoms on who IBS-C clinical differentiator adult needs relative often of discomfort. focus to the is

the the IBS-C more to Second, efforts to new physician accessible make increased we Telemedicine seek constipation chronic easily believe linzess.com by and patient to our as patients. care also potential for evidenced help encouraging visits growing patients consumer information, are promotional continues starts. and

and pre-COVID on primary levels overall our care Third, are having are physicians and professional gastroenterologists nearing promotion on our effort. impact efforts high-prescribing a positive focused selling

to be expect class-leading continues became LINZESS for And the major to class-leading will brand. to Finally, across paramount access success in another the payer of commercial formularies continue access we our preferred LINZESS brand payer in recently U.S. XXXX. maintain unrestricted the all yet

opportunities the goal advance of We life clinical of management the increasing cycle continue to LINZESS. utility number with a of

than in I of August, less children two contraindication studies. applied less pleased dehydration of than use box warning children on that respectively. the the very previously years updated in and less than modifies contraindication years modification age years to and of label those and serious The to pediatric XX for all in mentioned The FDA age. we the against age, box our proposed six of label of based risk the approved warning data generated As LINZESS the clinical am

of LINZESS As pediatric a approved X to The that was Since launch that time, is warning years linaclotide label and been safety that reminder, at the clinical years potential at the age. important data to of was benefit population this label has in better not And preclinical This age. risk to the generated absence on data characterize in population. currently clinical LINZESS due XX time. findings. update an patients to in data of any generating children the of in for there clinical been date profile applied reflects in pediatrics under XX use we've primarily

As ongoing additional linaclotide soon safety on the the that data will pediatric to label FDA reflect with potential updates clinical generated. as engage be the are to pediatric completed, all and we studies planned all plan

a cases, why top suffering efforts success. what Looking need positions disorders patients severe patients for near Jason? assets of every for medical underserved the around value we with that on of and the significant is We're is I'll to list ahead, we're need And debilitating, thank GI To and strong for for at In can improve drives of rationale. limited to we scientific growth from investments and dedication focused Jason and problem, urgency most this our often review performance. the turn CI and have strong innovative in call be built pursuing believe treatment this to strategy we're over no the lives these all employees, disorders options. caregivers shareholders. GI medical or new options, to now us and patients in advocates have our the making patients, that the This diseases. company I symptom and the delivering in day experienced their supporting reasons ranked on millions care. community GI treatment in seek the long-term the creating ahead innovative our address to financial to focused Ironwood. would see confident our shared like market. GI We opportunities team

Jason Rickard

good few Thanks, provide a have I morning, everyone. to Tom, today. updates and

provide COUR. release more allocation and agreement our refer on touch I'll for walk performance, to financial finally, specifics Please our press our through XXXX our information. with guidance. First, QX And I'll our capital detailed our review then financial strategy on

sales quarter grew LINZESS. trade net to by growth, by offset driven robust fluctuations. price demand to partially net channel the third and Moving inventory X% U.S. compared XXXX prescription of

demand price erosion. mid-single-digit impressive expect continue balance XXXX, growth the to will sustain, we that of For the LINZESS expect and we'll prescription

in the using which channel half year has was Regarding half growth the third in and quarter. dampening sales in a net full continue net growth net up the of of of fourth in inventory the growth continue the year. channel, first in XXXX, resulting year, fewer of XX% second to the through the is date for the meet sales to expect third is is as resulted sales expected the favorable and to sales and the to growth case in X% quarter, our quarter, And we X% guidance between fluctuations net year-to-date. Through

when out to the margin brand period in to XX% lower many I'd third the versus was the last primarily of year commercial details selling third restrictions. versus Commercial same to did Turning mix quarter third in not we expense quarter the execute versus margin increase LINZESS quarter result that the as due of in-person point an COVID-XX in the was profitability. in XXXX XXXX. XX% quarter XXXX, of of like third the

overhead quarters the our recall, and selling during adjusted the related virtual were quarter to three in of may expenses last year. you fourth first call As of XXXX details

as quarter seek to In being I growing disciplined net growth expense by in million LINZESS brand. sales driven to were just by last XXXX, flat net investment mentioned. and over year-over-year $XXX selling U.S. due continue versus time third Ironwood behind margins to revenues the were million of LINZESS We collaboration sales higher revenues, $XXX the offset year, through expand the which

profitability. We in of and million Ironwood's to the quarter was EBITDA third net million. XXXX, delivered adjusted $XX $XX Now GAAP income of

equivalents, million of in end Moving cash $XX and from cash and generated flow the cash capital at priorities. up $XXX to In the from operations and million third in million ended allocation the with XXXX. cash $XXX quarter quarter, we

And for of company, innovative As on shareholders pipeline expanding in that for most identifying create our back COUR. investing continued of positioning which as value this term. December assets, million tests and agreement long common over previously as morning have future we our focused a we're received buy such from disclosed shares XXXX, Board company success, We're of our growth second our investment opportunities authorization and to up patients pipeline the includes and to the announced the outstanding of our the quarter through $XXX with in XXXX. stock we

fortunate We sheet, which believe growth. have continued to a are balance for we positions strong well us

million our make to agreement guidance, of detail COUR additional and million to clinical perform an upon $X.X more Track million study. to approximately on financial payment CNP-XXX, upon study of the moving will I'd to Before payments of of and $X like designation Under the with the FDA provide we of $X COUR. agreement, nonrefundable million the terms $X commencement receipt for COUR's for upfront, CNP-XXX Fast option

incurred with be the near-term between such and to of hit of in XXXX. fourth the payments we XXXX After quarter XXXX such the P&L payments million to of review remaining $XX COUR's $XX million approximately expect U.S. commercialize pay CNP-XXX PBC. we exchange an treatment for if develop data the license from the exercise COUR for to the will in we We of in exclusive study, option, and the

up the excited guiding PBC. business agreement. we the will be sales net annual to collaborating be transform high products of in digits eligible for the potentially pay to to treatment the containing COUR help low to in And COUR double-digit commercial and of within Additionally, to term CNP-XXX CNP-XXX. the percentage to of of strategy. $XXX payments receive aggregated COUR single milestone million will squarely the framework of U.S. royalties principles fits with over our development the We're

the Going we're medical types these decision bringing to are And in assets unmet target at similar CNP-XXX to clear needs points. continue and highly that have market. looking forward, clear differentiated, we of see opportunities

guidance. Turning to our financial XXXX

$XXX to sales We continued Ironwood In of growth million. total net capital to back to revenue business balance call to EBITDA over adjusted greater sheet us well addition in strong $XXX remarks our million $XXX U.S. million space. Tom positions opportunities believe of additional GI X%, and and now to between continue I'll X% Q&A. allocation expect financial to continue the and to performance, than invest disciplined approach pursue our in to before invest the closing for we turn

Tom McCourt

extremely health for the joining proud financial everyone, our continued call and quarter thanks, and to of Jason, becoming Thanks, country's our I'm of leading vision of performance our team's this morning. at and GI dedication care this on for January. updating now forward early to our you Healthcare the Conference company. lines on JPMorgan We upcoming you may Operator, in look open progress our the XXXX outlook up questions. our

Operator

Eric Your Instructions] the first Joseph line [Operator of from JPMorgan. question comes from

Hannah Adeoye

This for is on Hannah Eric.

with first deal. to just So the COUR regard

some Just wondering the candidate the can assets administration the contrasts potential speak developed being to and how CNP-XXX dosing? the PBC. other mechanism And respect with and of of of with you for to properties clinical

Tom McCourt

of I'll Medical, Sure. Mike our have Head take question. Shetzline, that

Mike Shetzline

Yes. for Thanks question. the

acids, therapies of directed like are bile Ocaliva. So as things derivatives current and you're probably aware, at URSO things like primarily PBC

very much asset achieve actually towards directed trying actually system. tolerizing is is what the a because COUR the platform So disease-modifying immune to the we're with effect

it. encapsulates it is, In organs, antigen disease the today for we autoimmune antigen, liver and the antigen. the responsible they recognize antigen, asset an immune takes the that it does primarily What get of believe PBC the PDC-EX, Those tolerize nanoparticles. directed to it and that the nanoparticles system, pathology the is it's COUR what see disease and in to the is they spleen. So when the those PDC-EX

responsive So PBC. duct the the would responsive sometimes bile or pathology not autoimmune cells. or That's of then they continue the destruction anergic become less not and of

of disease autoimmune mimicking try by cells. to root your the So too. PBC, acids, question? the the answer bile Current duct Does that the COUR of cause the in manage principle, bile destruction therapies asset the targets

Hannah Adeoye

can to currently speak And bit administered are a Yes. you how just molecule, properties and it's little how the of guys the dosing? you

Mike Shetzline

certainly. Yes, Yes.

dosing and date sufficient So in far the the one patients will to to apart. given currently, so adequately two clinical suggest for that first-in-human be IV dosing, to the And that, evidence antigen. be models could tolerize doses, the PDC-EX week preclinical study

Tom McCourt

is So could the can symptomatic value this, to a It's this a term. It opportunity, commercial highly quite created we could imagine that like long be debilitating I that be in as it be could obviously, a disease-modifying have And quite this mean disease. breakthrough. patients. from obviously, the agent, a huge could be at And look a serious. drug you for

the And whether we're science. a We're to development moving in to So line or very I decision move the think this very looking way COUR with really But I certainly working excited the think not. of about we clear and about deal forward. structured gives us on point, clinical opportunity. we the excited a sight forward the asset we're pathway

Hannah Adeoye

And a the looking primary the like on XXX-day follow-up has primary just Great. CT.gov, study before looks period period. study it

to you expect you see data the have data on when decision. and after that hand wondering and receiving Just how data, option soon how to make that

Mike Shetzline

Yes.

So good question.

as So this first-in-human study. is know, you a

action, COUR it proposing. that. the approach and XXX-day value. very -- this of study PBC pathology the We why opportunity. ability as excited actually about all understanding the is good we're you clinical and the of the to is and And to a mentioned, strategy diseases mechanism interpret understand have That's that we in we're which GI the understanding delivers disorders, our So data a

the we with where is pathology, to with PBC at currently to cells also the of also PDC-EX response antigen. actually and to in -- but alkaline of their We're T understand some biochemistries the things the opportunities in can the reactivity the involved like the in liver to check platform and within at asset, aspects COUR. marker COUR immune-modifying objective for of endpoints on like to which the progression also So a recognized we're working disease look only the the progress the patients going have study PBC not or improvement study, look phosphatase,

therapy, the You see that that's goal the obviously treatment. can actually of during improve hopefully,

of data to study. data will give obviously the [indiscernible] we that need that clinical be drawing of us we'll that integrating study. the hope for do sort we'll get the And They're exercise clear option. through So through the decision-making the all

Operator

line Stanley. comes from David Lebowitz Your question Morgan from next the of

David Lebowitz

it individuals' the currently you about bit it is is asset could you is guess look on impactful a -- tell these at actually more When little I the How how indication? it How us managed? day-to-day lives? CNP-XXX,

Tom McCourt

Mike, take do that? to you want

Mike Shetzline

Sure.

debilitating a degree a not bile is function liver and disease. to need of chronic liver that transplant. uncommonly, PBC destruction So to very ultimately liver progresses duct a It, for and -- dysfunction lead can

So it's medical a very serious condition.

the suffer very acid itching The On ursodeoxycholic intolerant, Ocaliva. take they people can pruritus. And and patients or fatigue And can way that, for debilitating. current clinically failures, be URSO quite URSO. the -- are for to detrimental therapies then

So acid those derivatives. current therapies are bile

So flow. bile they increase help liver the

patients in So is the that it By reeducate the they that therapy flow with goal that do potential potentially out note destruction is bile that destroy some bile of and taking liver flow to that of we cells. therapies one flow. clear to the bile immune a the reverse obviate the bile destruction, eliminate whereas what through immune the talk bile And bile disease, patients and disease very or the how antigen, or destruction through completely managing that reeducating underlying cells, would of may which the again, course were the -- destruction T disease-modifying that that's is cause to duct bile symptoms. have better not the to and they to the things fibrosis. a cells. And destruction provide system treat we're get should in reprogram body meaning But immune is CNP-XXX the that liver the cease into drive better that if system. much of the duct responds and Those could liver targeted even that happening the duct ducts profile, what's the of impedance when And the digestive course PBC, about the the patient, antigen, has and the get its T through to PBC impedes ducts. to PDC-EX that the do. By

David Lebowitz

at as look to how other terms this and now them you therapy do If the landscape see in the right of compared you for drugs promise? PBC, development in

Mike Shetzline

Yes.

the [indiscernible] bile acid like that therapies along same lines, mechanism even the of that So on the still considered and acid are mimics. bile being or many such focus

from So to still the try approach liver. enhancing patient just to the PBC bile they flow

these assets flow So underlying destruction. is cell really, liver pretty but that T the really mechanism don't by that landscape of competitive much improve the to get consumed

Tom McCourt

Yes.

I the about they're a the of the certainly of experts, and we've for could we've mean, antigen have really real a to this breakthrough -- very talked it hepatology able to of disease-modifying target, patient I as being agent the number this specificity excited as identification think will treatment. the be and be that been first

about alone I the Dave, So think, all really for this to opportunity and we're and really position excited it very changer game -- in be this be a space.

David Lebowitz

expect question far last are would What we I what timing? the to and trials path path on, as as forward. market then far -- on as as guess, needed And

Tom McCourt

Mike, the trials, you to get as approved? far acquired -- have as

Mike Shetzline

Yes, sure.

clearly, has a data set that tolerated. demonstrated benefit/risk, in to patient So we the the clinical the current new have the patients. and need is population really And well that we're going proposed. platform This to be data is as understand PBC study initial to safe this

expeditious more really orphan this be they any the patients. designed sort this data to inform it need we population. So market. patient But of would granular that today rare obviously with an absolutely could is and and which data that an from the means new premature be have of get is sort type the what -- would again, We'll to initial disease, will in how have studies next this But also too to study to can options data engagement in subsequent usually, be agency. without see be

Tom McCourt

Yes.

to this the The designation a with also FDA review -- as things attractive one us that's of potential is move to market quite on clinical part of by as for a time study, the we priority. see David, be the forward. the why think, also could reason -- I be accelerated could of outcome that's attractive. we here value the And depending it's really significant

Operator

Your Instructions] Northland Tim comes of next Capital. Chiang the line [Operator question from from

Tim Chiang

would at COUR the I'm this the XXXX. I of their there there sort just with just first back. website. be data I wanted And guess for drug quarter is And looking of target status CNP-XXX? orphan -- go to Are already

Tom McCourt

Mike?

Mike Shetzline

Yes.

I that, case. I think confirm COUR can think that's the but exactly

Tim Chiang

the criteria guess, And guess, I is it website. failed -- looking this was also IIa failure that I that right? for ClinicalTrials.gov at And I on, it's of treatment it looks patients Phase like inclusion the care? have standard study, Is

Mike Shetzline

and/or patients that And fail in intolerant URSO, I earlier. URSO. It's they're bile who currently people who derivatives available Ocaliva. tolerate are again, And have URSO or either who mentioned for Yes. the to can't is Ocaliva acid failed

Tim Chiang

the with is current rate it What failure meds? pretty Is high?

Mike Shetzline

Yes, it's a range.

terms the clearly, it patients up even studies it's unique or even they is immune-modifying benefit get to Ocaliva. URSO really I'm demonstrate distinguish me But start that patients profile with or is the to to and wrong. -- on applies distinct successful even to synergistic people We'll take first this XX%. proves we that, important that when of to mechanism this to fact from get trying what very system, don't do I Ocaliva. on or URSO asset tolerize But URSO can potentially then Ocaliva, wouldn't immune in understand it's this think So that and much if on

Tom McCourt

is Mike piece this initially this think could be the this probably be earlier together. that therapy. I over obviously, debilitating When disease-modifying how into these is, for PBC and in look a two -- think, it there's other about as -- at work you would of up time, those probably to failures. an problematic And treatments, agent certainly will Tim, mentioned, pulled opportunity

disease-modifying indeed So it be can agent. a

Tim Chiang

And BD additional you're side. guess assets front, bring in on on obviously, looking mean, I to the pipeline I the Okay. for

you mentioned had previously. that area think Is an celiac of still interest? I disease

Tom McCourt

which about to -- is of this talked in this celiac in it certainly area interest. of talked look an We've pancreatitis. Yes, lot is. There's opportunity space disease, attractive We've and addition that PBC. activity about a in

Operator

further your time. And conference participation. for This no are today's there concludes Thank at this you questions call.

may now disconnect. You

Ironwood Pharmaceuticals (IRWD) 6 Nov 212021 Q3 Earnings call transcript