IRWD - Earnings call transcript Q2 2022 | Ironwood Pharmaceuticals, Inc.

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Operator

Good morning. My name is Stephanie, and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals Second Quarter 2022 Investor Update Conference Call. [Operator Instructions]. Thank you. Investor may of your Director Roache, Relations, begin you conference. Matt

Matt Roache

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

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

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

that, our the please turn those you I’ll slides website With the of separately. section of So, in, go over call Tom. access the accompanying to to for to dialing Events

Tom McCourt

clinical the us second momentum convertible second quarter and our business for we results. everyone. in Good share execution our our the direct strong today thanks demand medicines treatment patients. continued across team, our in The by repurchase LINZESS growth, second along completion from and demonstrated joining Matt. robust result and Thanks, positive of progress redefining of quarter The commitment a GI, the hard morning, in program, prescription as programs, our important quarter, of of made to advancing our And work bringing standard as with XXXX care is share diseases, our shared GI of repayment advancement to the in notes. we

U.S. GI mission health Our leading the in care to become is company the

on of with I’ll brief overview slide start Now, strategic our a priorities six.

Our strategy demand to IBS-C as a starts and constipation. remarkable idiopathic and LINZESS. with prescription continues leading launch, for growth years Since XX adults among health experience care LINZESS acceptance chronic treatment maximizing widespread with practitioners nearly prescription ago

X recently We and volume. in second LINZESS treated to are increased surpassed quarter, patients report achieved high prescription year proud launch In the brand new-to-brand since million unique X%, quarter, the the in all-time prescription prior versus an LINZESS demand XXXX.

appropriate for Through symptoms. treat the year-over-year. turn believe LINZESS in-line LINZESS chronic there We performed still demand growth constipation prescription of to IBS-C with prescription has prescribers and expectations patients to is digit first the or drive opportunity As idiopathic to growth demand patients double half brand. significant prescription their XXXX, and additional reach with new

and out timing shared to clinical in we data of continue study pediatric IW-XXXX quarter now to for In our functional our track Phase addition progress We on third and with to to XX the the commercial read trials. ongoing make this remain expect success previously constipation with year readout of year, in LINZESS, six CNP-XXX. olds X we

Mike, will position will focus acquisition provide innovative continue we we sustained convertible continued in growth. of or our GI And flow. in notes cash minutes. of believe company the repurchase to and assets finally, $XXX We as update completing during on We a in through cash cash in-license an the our it pipeline continue for and with XXXX million strengthening few pipeline ended cash after over our QX profits balance and sheet, share our to quarter. repaying program our deliver equivalents on

We growth with forward. are believe three will the pleased moving continue ourselves position our and we across progress strategic priorities, to for

exceptionally of of well, let’s on IBS-C Now details additional continues to with for branded Idiopathic U.S. performance to medicine reinforcing LINZESS both in volume, X the the commercial patient position its seven. and further Chronic new Constipation. treatment the adults LINZESS prescribed refilled the powered turn on some by as Number slide perform and

believe in As particularly the prescription market grew the digit, impressive, quarter high of demand XXXX the year. earlier, line single-digit to second the is full in growth expectations X% during in double our LINZESS strong I We year-over-year. demand growth the demand year-over-year for as relative second achieved the demand pandemic. mentioned XX% Overall, the the is first half recovered from with COVID-XX growth for XXXX LINZESS quarter

of In to now a high in all-time grown has size total day an percentage have making addition, prescriptions. up of led prescriptions, prescriptions prescription. This XX% retail as XX of the total average

both reflection in the access. focused class and slide profile, The demand and to in impressive investment promotion LINZESS a strong Turning eight. growth consumer prescription professional payer of leading is clinical

of was maximize brand. end our the prescription total all-time efforts for LINZESS, an at result XX%, As the share second a the high of to quarter

two within year, share IBS-C past the market. has LINZESS constipation generic grown chronic idiopathic branded points and approximately and the Over

New prescription increased, the of strengthening has market share also further leadership position LINZESS.

nine. Now slide

American updated guidelines. guidelines the adults leader market LINZESS with an millions Gastroenterological Association the receive highly by of the this a the only of ongoing with in chronic treatment communicate from customers. of AGA updated will supported symptoms for update the frustrated was importance the IBS-C. recommendation treatment A XX, based for treatment strong physicians in LINZESS the help being high patients, was tool recommendation to idiopathic received On quarter treatment addition with and evidence In IBS-C further LINZESS LINZESS evidence. the a of our prescription in constipation, our These that clinical the strong June acknowledged in a reinforcement, level are IBS-C their IBS-C a and branded to guidelines. living of work adults critical during powerful for treatment to can provide help of care we interaction to

need Finally, brand for for we patients are program the treatment. even clinical the of more committed and lifecycle management to utility to advancing LINZESS in the broaden help

excited grow the maximize GI. Ironwood’s continue Therapeutics, to We position through strive LINZESS, GI in Innovative within ahead opportunities clinical and community. of are advance we broader we as GI, about contributions lead position leadership strong way to We in GI to also to in programs, our today the financial and are seek our the the and us both strengthen

the ANMS. Ironwood Motility Over and days, Neurogastroenterology Society, sponsoring few be the will young next American or XXXX form investigator the at

ANMS shareholders had sponsoring to hand employees, the support. Diversity we to pipeline also our all for of I the and honor programs. always, We hope to discuss will of patients Thanks some the Ironwood Mike over it Mike? see now Award, to your to and there. as you like

Mike Shetzline

Tom. good Thanks, morning, And everyone.

on data progress pediatric I’ll top slide potentially start XX and the with good positive currently make for on time, programs. functional across program quarter. the pipeline was utility a and three pediatric LINZESS year functional opportunity therapies third data This approval exciting to linaclotide the option is with prescription executed, to we six bring new study now and in line expand clinical our completed as constipation olds FDA expect in of well XX. continued The approved treatment to clinical patient enrollment no are this an population, FDA assuming constipation. to there We

we’re such potential as syndrome of a owned Ironwood and interstitial wholly pain conditions, guanylate Next, a advancing and cystitis, cyclase-C bladder IW-XXXX, for visceral endometriosis. asset the treatment agonist pain

have on Phase of will from healthy the bladder in We for syndrome. the plans patients cystitis the benefits suffering pain begin study to volunteers, X IW-XXXX pain us completed potential focusing interstitial and proof-of-concept studies enable which

We with We’re currently targeting of clinical conducting CNP-XXX the proof-of-concept study, finally, are top for to the for study cause to COUR’s now review a success and to And CNP-XXX. PBC, with data PBC which we eliminate on year. study potentially believe combines trial disease potential When COUR nanoparticles design the which turn for the they’re to patients. PDC-EX finalize Cholangitis. currently antigen working the has paradigm is in be of the Pharmaceuticals CNP-XXX the begin bile over line enrolling to therapy start to shift is at treatment investigators, and performance. first patients. end the in to will pharmaceutical that financial to-date, the this out in our and is the and target state-of-the-art to novel XXXX.We’re the COUR Sravan immune approach, truly With that, the excited with I’ll root modifying significantly about of happy activated partnership to tolerate Biliary speak Primary progress track system sites destruction the core get duct we the read it working if

Sravan Emany

may Mike. a begin by wherever I Thanks, Thursday you earlier to be. And morning Tom’s you, Hello, commentary. will everyone. reiterating pleasant

delighted first refer beginning of on on by for our guidance driven we financial strong achieve Please Release our impressive our track continued the we forth are the with remain detailed at this to Based put to-date, performance We performance, our LINZESS Press half to growth. demand year. information.

to up prescription material to second In net quarter and net impact, U.S. price half up previously quarter provided year-over-year. second by a of is X% expected sales and of XX. was first of the for Strong is sales prescription XX% in fluctuations year. versus slide over decrease sales anticipated up LINZESS, decline demand prior full our Inventory XXXX, LINZESS was a million The demand the channel are XXXX, price X% on year-over-year, have offset to than – compared the net fluctuations more not Now, growth inventory $XXX net guidance. Net is year. the growth XXXX. were for

to U.S. digits growth expect growth. For sales year, net in single the driven low we double-digit LINZESS full by demand prescription the continued

of to XX% XX% in second to the LINZESS profitability, compared XXXX. commercial quarter Turning in the brand XXXX was second quarter margin of

$XX in of LINZESS revenues, revenues the Ironwood by revenues collaboration quarter Ironwood were $XX to primarily Moving of driven U.S. second million, million. XXXX,

Turning tax report of throughout expense the income on quarter P&L expense. our XXXX, rate continue effective Ironwood to expense, of tax will $XX XXXX. during second recorded income tax to Ironwood and tax our million

loss net prior majority the carry-forwards net Ironwood operating has our a be from As we operating use years losses. reminder, will expense of as therefore and income non-cash significant taxes a our

income Moving allowance. tax to XXXX second million a included the to the quarter valuation adjusted XXXX. EBITDA Ironwood’s million net nonrecurring income net $XX the of GAAP second reminder million was income release in $XX $XXX and as related was of GAAP profitability, quarter benefit,

the ended priorities in quarter with capital generated In in second slide on May, and share In completed flow allocation operations cash million XX. repurchase the we equivalents. program. $XX cash our we and million cash and $XXX our million Next, cash from quarter, $XXX

the price A repurchases shares December million of XX.X overall an repurchased share our Stock. of which XXXX, $XX.XX, For per in program, commenced at Class approximately Ironwood average X% under Common

the $XXX of In and in repaid we addition, aggregate in XX, XXXX we outstanding. have the of amount in convertible million June notes XXXX, notes June, convertible now $XXX principal remaining as million full,

Over the past capital our in financial million months, XX to $XXX Ironwood position. roughly has strengthen deployed

Our assets to and to maximize innovative, our GI capital add include priorities allocation to highly pursuing investing actively LINZESS portfolio. differentiated

investing focused value our shareholders long most over the create are term. the on for in and and opportunities identifying patients We that

a sheet a which believe for us to and balance profitable have approach fortunate well growing, and to disciplined brand market-leading continued capital are take allocation, we strong LINZESS, in continue positions growth. to We a

on was I XXX Index SmallCap like the would moving added to to in Ironwood that our June. S&P guidance, Before financial to highlight

this difference we reputable as are Index to of strength make Ironwood’s financial for as We people with recognition to gastrointestinal momentum is be a excited living it and to added diseases. continue

our XX. guidance XXXX slide to on Turning

we year the XXXX as remain of confident of in We are continued strength prescription growth. expectations our full demand LINZESS, reiterating guidance with double digit financial

our three to adjusted U.S. progress of are EBITDA We which value. all want deliver in of million patients the other $XX supporting about excited their includes opportunities now we questions. strategic thanking of priorities, by disorders. shareholder LINZESS $XXX GI and low and million, Operator, GI $XXX sales and continued close us we million for the making growth well patients, caregivers improve you open therapies advocates employees, of the remain focused ahead may Ironwood up digits. for positions and of advancing continue approximately We We believe revenues dedication lives growth. I greater shared to net for company million. $XXX the our and than line are to single royalty revenue to on for expect our to advancing and in the

Operator

from Sandler. Amsellem with Instructions] Piper comes David [Operator question Your first

open. is Your line

David Amsellem

thanks! a Hey couple. Just

So about functional peds. constipation study the in first, wanted ask I to

Thank commercial the to So linaclotide. discussion way product Do does What’s ask then in or margin, its you how in as of commercial a you. margins and as franchise there how forward-looking increase to that over its of might be that over-the-counter data, would you that to – advance the intensive is, a What the think margins about could as data, know commercial assuming do gets to later wanted the right of favorable term? think the potential see again And life life, the surrounding the kind conversation with question that cycle do you evolving? have way potentially the extent that you less I long promotions? the get you dialogue on FDA secondly, version of commercial its positive? subsequent sort

Sravan Emany

David. morning, peds point first I’ll the and – to then your on I’ll Sravan. the let’s question margin handle This about thereafter. Mike respond Good have is question, first commercial

Michael Shetzline

sure. Yes,

I So under all the LINZESS to certainly your from had think constipation, in X tolerability and at of the And support patients a and warning overall encompassed the year those alluding that of the it XX patients additional was and XX. use to current that study old pediatric age certainly the basis XX adds to, of we recall you launch, the the you’re safety below. box question of functional

the X we’ve and Phase only of to less year study years and a X a olds talking constipation, to we’re also in year’s olds pediatric including kids olds. actually X prior II got years now IBS, one done to with a includes of functional X XX in XX So which patients, year addition now, about a us study number the over That patients studies of the revision X with study, a age. than in box,

year population, addresses aggregate X so that the patient XX mentioned. to change data last But certainly So helpful. just did old year the the the in with this population to in had with that study, I is actually always relation specifically additional we which submission agency we’ve data

pediatric, clinical in we forward move studies the we As additional with program doing. have we’re

in now AbbVie. year in study another term partner off our kicking X near X to We’re the with olds

move this tolerated safe all label to on the labeled note, had, one helps on and well pediatrics, note goal to-date patients. how please and so the which your discussions about to patients But So support confident in in to patient studied. to all currently data population, us final an that engagement And the pediatric for with OTC question not that just we the for product. will demonstrated because is the have with be to LINZESS we language future addressing together ultimate appropriate language further safety be in agency remain in box progress all we’re further real and the pulled have we this studies about to the pediatric the tolerability an in discussions

Tom McCourt

is Tom McCourt. David, And this

this there clear comment forward looks can a certainly path of maybe regulatory is Mike a from front, piece other but that. on like The

pediatric about You requirements. like very as the obviously that concern the and is think indication the very our most very was know know certainly program occasional both ongoing FDA. whole constipation, safety you the the thing with making with we’re those FDA with design it’s progress collaboration for meet pleased originally well that would we’re important what dialogue a to had here will as and really get and partner, look the the that eliminating But – an hypothetical, and trial drug the we’re confident I very, clear

Michael Shetzline

OTC had terms constipation so in and occasional like products MiraLAX, of precedent with for approaches preliminary regulatory have we’ve discussions clearly including some with we our – Yes, partners.

a So I that continued have. a we are it’s in that carry position think to good we program forward and

Sravan Emany

then second And with start David, question. your I’ll

start think managing where by and all, going today about about company. where we’re about of commercial expenses. with then are and First question commercial progress the we respect we we’ll I’ll to on how pleased we’re and we’re overall little a really bit talk margin head answering where margin your our

First fluctuate Commercial year-to-date expenses June margin are compared in XX% the throughout margins point June to can the quarter-to-quarter on based year. through is, XX% year. through of timing XXXX XXXX commercial prior

year. a the investment out commercial the As largest DTC quarter the reminder be launches in of to there, year our everyone second for and due we spend to of where the tends the the commercial have timing

lower full impact fluctuations. for said second expect but impacted those by unfavorable sales were also the So by in on an in the quarter, quarter. fluctuations, material XXXX fluctuations those had we the quarter don’t this year inventory margins which commercial primarily a We earlier, inventory impact was net as driven

And expect feel are we’re year, profitability with and from hit and and evaluating. brand we we stand, for where constantly to respect then a – to on so where want track long go, like the guidance we term we’re we for our to perspective we where where

always with margin can We don’t on We’re those room try drive if efficiencies. fine where and have grow improve else and there we to anything partner, the Tom, and do know and still to front tune those our how margins. looking add. is continue we’ll I commercial you think to

Tom McCourt

Yes, thanks Sravan.

had in remember, were because getting an additional, and – were out think of are was the of quarter on the we interesting you surge we know to the thing other in the second pandemic, XXXX billed short one. as the I that year-over-year demand calls of to the coming was We pandemic, P&L. quarter

were with things. combined two margins the those favorable So more

with mix really real DTC and and drive level to Sravan we’re growth keep investments investment, is to certainly near delighted we’ve mentioned, of regard one in regard term with the key which access, professional long term mind, payer the marketing and the the making to both know progress as you of for refine promotion, with So continued we’re the brand.

Sravan Emany

that question, your answers Hopefully David.

David Amsellem

you. thank Okay,

Sravan Emany

you. Thank

Operator

Cowen. Instructions] next comes question [Operator Your Boris Peaker with from

Your line is open.

Unidentified Analyst

is thanks. Nick a Peaker. Alright for have I Boris just on great, questions. This few

like wondering First then be COUR data and is the Phase is I some we’re from IW-XXXX. trial, or now if further right see I whether before Thanks. is, CNP-XXX strategy second the the going it should IW-XXXX? was II to what trial? of expanding safety guidance to on if pipeline beyond beyond on question and initiation your whatnot expect the we And – my Phase data potentially

Sravan Emany

Mike And again why Sure, the look, I’ll plans first thanks. you our and then address there second. IW-XXXX question and the on don’t handle

Michael Shetzline

sure. Yes,

So Phase Both a single It to the did in not IW-XXXX complicate ascending as that well a dose dose for healthy I studies was time. multiple make of studies those issues as any proceeding POC the starting – program it year. us this to were on of completed any was demonstrate study, volunteers. study of studies. those Both for end ascending concerns

are certainly going disseminate how we’re domain. data we So we in data, now clearly put will that discussions on but having through it to and public that the

You though I Phase put healthy opportunity. just trials the may so because the publicly, – Even will know obligated healthy are were studies clinicaltrials.gov. to but certainly volunteer data in are they data from disseminating that that take committed we we are in not those to registered volunteers,

Unidentified Analyst

on strategy. so And the on Great! piece

Sravan Emany

think success, highly these we’re LINZESS which innovation, balanced to for and future take continue I’ll that approach actually bolster assets Look, our start saying life we I differentiated growth GI capital includes cycle are to We commercial maximizing going the pursuing believe to company positioning a deployment. portfolio. to by to management

including to long acquisitions. such on CNP shareholders licensing most identifying other patients our in as for and focusing the investing opportunities value and term, over We’re the and create

continues point team opportunities. engage with for us, this to And evaluate parties so time, third our at and in

better You assets. as potentially know this it’s finding us a year for market, this been while buyer

and Tom to disciplined are to But acquire can create evaluating we in we for going I find set meet – and I opportunities value, think that to we’re we’re a have specific pursue know, going we needs. any comment bar continue ourselves our make them, internal going term if shareholder on we not asset other don’t beyond to to high or... potential be that. long any is and and criteria sense transactions we’ll efforts

Tom McCourt

may with know that’s very may on I exciting and thing and into turn to Well, activity I and the emerging you spot think in lot technologies think right be there’s attractive. of Sravan, the there’s other is regard something now market look, dynamics a that treatments that

want bar like and where So high again with growing Sravan’s disciplined our and we overall really we health, we’re to is regard our think as capital. how point, be financial of to allocation to about the far are how we as we just

Unidentified Analyst

Great! very much. you Thank

Operator

There This today. questions time. this Thanks everyone today’s Instructions] [Operator at for concludes further no conference are call. joining

now may You disconnect.

Ironwood Pharmaceuticals (IRWD) 6 Aug 222022 Q2 Earnings call transcript