Mallinckrodt (MNKTQ) 6 Nov 182018 Q3 Earnings call transcript

Good day, ladies, and gentlemen, and welcome to the Q3 2018 Mallinckrodt Earnings Conference Call. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session. .

As a reminder this conference call may be recorded. . to host like Mr. today's now would introduce for your conference, I Speciale, Relations Dan Officer. Investor begin. may you Sir,

Thank you, morning, Crystal. Good call. to today's everyone, and welcome

our Mark Dr. Matt Joining our our Chief Romano, Harbaugh, are and Scientific me CFO. Officer; Trudeau, Steve CEO;

of let you few details. Before we remind a begin, me

possible our obligation expectations, call, future the to forward-looking or stated statements, the results, materially. note contained assume We our refer no it's actual if expectations. update us could of these for be even forward-looking statements. of statements, make Please On results some materially to to forward-looking you hear and change in-depth the in such encourage inherent you'll limitations explanation actual different statements cautionary a from we SEC filings more

page and to see our consistently our debt the from Investor We net be X.X ratio net at related in leverage post times. Relations selected quarterly website, example, We of channel, on A company to will can financial performance. adjusted measures look should and important can of available mallinckrodt.com. information, information. GAAP channel our website use for is to a on was website non-GAAP flat time-critical leverage as use this you the and basis which our this found adjusted for reconciliation you release, debt as to these today, a measures our to our distribute We prior earnings provide our also quarter

we discussing on to basis. unless specified, As calendar the currency growth net noted all the are will are comparable and quarterly in XXXX be our constant comparisons ranges period a otherwise press release, sales

over to has to our morning, diluted to for Mark? adjusted you call me With earnings $X per share. saw been share As per the let that, guidance Mark. turn likely XXXX raised $X.XX this

first period some progress look half coming strong illustrate goals Dan. We're the quarter, for Today you year. we'll performance on and of months. of build the with against the the very forward our and pleased strategic results key making from in cover in we're some the milestones which overall to the Thanks the our highlights can

portfolio expectations. to to the performed end worked despite patient across has and dynamics ongoing high digit products improved mid-single high-single Acthar of steadily of challenge XXXX. market Our demonstrate we've sector, healthy continues the And as our at the trajectory specialty sales billion-dollar hospital growth the withdrawal issues through has the that

to also on innovation on priorities we've transition activities XXXX in We our go advanced seen Dr. and outcomes the through in comments. further conditions. Romano established growth gains for development strategic we his journey to us improving significant of support and company pharmaceutical specialty year with a our severe focused and will an critical patients and lifecycle for accelerate which driven is be

update priorities quarter. Let most remind and brands the and you first again me we've our these of productivity some this we well once you critical maximizing in-line development contribution executed of on the and With portfolio, the near-term and both advances of made. priority:

product where the sales For of year-over-year performance Acthar, are the with pleased declines we're trajectory narrowing.

these expect trends to continue. We

the and clinical presented recently number and prescribers. foundation both as such MS efforts registry with Phase XXXX discussions access X coming payers quarters and build a our This data data those utilization. ensure important data of will of and see to also We that of the patient appropriate readouts RA on in support is

and appropriate example patient trial how populations to a RA study dosing define the are clinical Our designs design helping recommendations. is us of good our

beginning with RA or clinical Over we key the next steady year MS. plan to data across deliver of so a cadence and indications

by with to history long industry-leading, and value INOMAX, be exceptional remain well market both the It's mind sales strong sophisticated growth keep sales demand for $X NICU. share and of integrated service record in will and performance be contract also believe XXXX in expect stated, comprehensive are customers strong in above INOMAX consistently U.S. we and exceed the as The On at isn't we and combination drug oxide; XXXX system, driven brand's it's and the or net $X levels, nitric above for future. a we've historical markets. net and safety Acthar historically as confident in important just billion. a our As drivers model key will continues renewals device billion to patients, international

arrive, event, on We the a expect substitutable patent opposed likely believe INOMAX clarity the device generic. XXXX. competition in branded that litigation does we it to have would of as in to if any the greater be of In a process middle form

for and value prepared the patients we we in any for the INOMAX commercially customers, are market. that believe proposition Given eventuality

Therakos the in broader growth CTCL minute. Steve in within product has programs continue. drove development will Turning Europe, execution with commercial label. this the In also sustained of ECP an Therakos. level pleased the made Focused a particularly OFIRMEV, patients. utilization in efforts, across and shortage multimodal In opioid we're combined of to drove Europe in demand interest the non-opioid detail strong continued will of indications as significant pain our the ongoing and increased shown and in growth. commercial anticipate management appropriate in We quarter the progress U.S. this growth we trend with use grows customer

Our second further priority streamlining our is organization.

make investments as that We we and in the clinical SG&A enhanced innovation, to targeted will launch readiness in anticipate and reductions capabilities drive in enable continue to such programs our digital growth development, future. expenses

us strategic expectations our and ahead of well objectives. Our to in results are are enabling our XXXX implementation accelerate of

We go strategy is that highly priority on allocation again are strong ongoing making will moment. a in advances the focus reduction. with once disciplined and executing capital on front Matt third details debt a Our into

opportunistic other regarding remain of also uses We capital.

momentum quarters, should a expect maintaining key see. looking pleased with both and are forward progress overall and things growth So to our look against strategic you this priorities coming long-term to with very year-to-date, We few XXXX we're our our ahead initiatives. to there

see First and with strong in-line you'll focus ongoing execution, on products. our both development

updates data an Second, our anticipate number we across portfolio. regulatory increasing of and readouts clinical

strategic we'll capital provide to strategic debt finally, and lifecycle now explore activities pursuing reduction Steve of we detailed more for business. portfolio, range we're of to our priority. And continue remaining ask Third, a the to on Steve? I'll drive with key options the specialty a continue broad a allocation generics update some development across

Mark. Thanks

programs, of over diverse to continue lifecycle well mid- late-phase with portfolio dozen We to ongoing a development trials. a in management progress

and In reaching important data key scientific at generation addition programs milestones. health and communicating research our substantial are research outcomes several actively are and to efforts and economics through publications we research activities, preclinical meetings

activities Let's company-sponsored our in-line specifically supporting first brands, trials. discuss

suggest modifying a of of of RA XX%, The in therapies XX% Additional study's therapeutic low symptoms the and and from and XX% challenging that RA at interim Acthar this data despite College improvement at the continue treat activity RA last patients substantial utility These reported persistently X XX to sub study more also ongoing of XX% active proportions based Acthar achieved there enrolled experience Rheumatology show with signs on multiple all the the achieved disease patients, disease analysis criteria. to is of weeks ACR whom of potential midpoint and in open disease was period Phase steroids. results American response label month. population

our from The completed therapy. help will be trial of additional patient the the benefit half second in screened in for optimal the planned, XXXX clarify most appropriate each first treatment of in the Also continues. withdrawal was and patients condition. first this is trial. population portion define month, and Phase complete XX our studies phases patient Acthar help registry XXXX. last of early duration of progressing the will and MS uveitis will weeks sarcoidosis study, whether the relapse to Both latter to lupus hope X a Acthar an Enrollment phase, randomized in and We as of the for

proof ALS study target. of concept Our enrollment Phase has XX% surpassed X

development Acthar In device self-injection device plans. the the and INOMAX next are with previously generation delivery of aligned addition, communicated our ongoing, our

been both continues. treatment accrued Xb/X a has that expectation anticipated treat neurodegenerative typically substantial that from in the as groups let our the childhood in a might of neither neurodegenerative ultimately effort Accordingly, showed arm presents product pipeline. type separation development product our our VTS-XXX In did the importantly, the observation. from benefit. data is C, the have on in condition trial, trial was on worsen our Phase placebo. study statistically a not nor an significant would and The over and VTS-XXX over VTS-XXX disease of completed me development is ultra-rare, placebo group course registration review would show XX touch that period progression based disease recently But Now the complicated, weeks but required to the an attenuated fatal. still of treated Niemann-Pick trial show the

to VTS-XXX to with trial potential year. to results forward. And this the important CPP-XX/sulindac patients know our emerge their top patient trial a in benefit our programs, VTS-XXX of the data, this the last FDA primary of clarify in been based polyposis group totality path of single late-phase Niemann-Pick the achieving for open based committed the potential This consider will safety totality better of understanding meeting the data that view expect pivotal and should partners next as carefully VTS-XXX we be acceptable. label of are a line approvability us available is we familial late-phase indicated We StrataGraft, other on The the step. us. continued internal advancing the on the has in Several patient At of advanced August, treatment We potential ongoing to an the potential of having terlipressin data, visit We the the early their study believe October. on this we FDA work pursuing continue anticipate target C well. programs plan. for type our a coming remain deeply of will completed is on adenomatous to in and to not as most and the time, of a treatment last current investigators work. are Two assessment in Patients, with importance portion families, and understand endpoint. at we or months to treatment with of that

X anticipate the treatment Phase enrolled of second the of in and completing program for is type trial over this half terlipressin XXXX. we syndrome Our hepatorenal XX% X

certainty X X program XX% treatment as which greater of deep full Phase The the and FDA Importantly, Phase of trial this progressing under X thickness positive. to in approvability than more for protocol thickness trial skin is regenerative is Phase burns the therapy pivotal being if well. for StrataGraft, development assessment partial enrolled. is development our an conducted provides special burns

a program, evaluate an to awarded FDA if Type with supportive. As A quarter, we mentioned late data the this will continue given the RMAT for Considering with earlier last are I are year. designation FDA meeting to the stannsoporfin, to we submission preparing engage this the

robust risk discourse clearly of issues target with perfusate the there viability outlined limited oxide looking we meaningful pipeline nearly transplant. and population the design of advance the CRL. are with and in the more development key has the severe to our population, opportunity update, through associated regarding agency nitric other evaluating a the to forward vivo failing is options enhance which This of lungs very to potential concept lung halfway our who from leaders, to intervention. and an proof population discussions infants intensive trial of higher hyperbilirubinemia suffering for Following study and we in ex opinion believe may marginal few therapeutic are addition phototherapy Last specifically a be we're program

let look to forward summarize quarters. over you the next milestones Finally, several specific should me

timeframe RA complete XXXX. as results have and of available second as We top the be For trial and the half early half XXXX to and of by well. enrollment potentially in the enrollment completed that completed will registry the trial in lupus our Acthar, line ALS hope MS first the as

CPP-XX/sulindac programs, line let the through the Matt take both pivotal top in to financials. second year. trial that, turn Matt? us development terlipressin are and me results results first the anticipated half quarter key For the the who'll it in With and StrataGraft of

Steve. Thanks,

million, $XXX from share operations per the an We $X.XX. diluted For of income prior-year X.X% the over reported GAAP quarter $X.XX compared increase were sales net period. with of continuing

were $XXX Our adjusted sales diluted X% issues. net a earnings share non-GAAP was the decrease resulting patient versus withdrawal from per $X.XX impact million, of residual $X.XX. Acthar

in Therakos $XXX to generated sales, growth net also continued OFIRMEV hospital in in sales, XX.X%. X.X% our X.X%. net the of increase to products, of with increase; with a well Turning million million sales quarter. in and see quarter $XX net AMITIZA $XX strong INOMAX the $XX an generated million, sales performed net up of million

metrics. operating to net the on XX.X%, me period slightly XX.X%, company mix. a some share decreased from to down let Now of product as Total percentage adjusted details primarily due gross in profit sales

a adjusted XX.X%. was sales percentage SG&A to compared as Our XX.X% net of as

SG&A been have the our with synergies. through of We acquisition to reduce benefits pleased ability restructuring and

As annual you can our towards SG&A strategic priority by rate made to run we've reduce advances see, significant million. $XXX our

portion reinvestment as was advancing for these X.X% indicated of product compared are in expense capabilities sales portfolio. like XX.X% our related a as to sustained the to and reductions in-line business of net generating for the previously, to reflects increased quarter, a as However, R&D investments allow preparedness. last percentage data also which, much launch pipeline in our and

percentage R&D same can to in range and You expect of quarters. increase sales coming spending the as or R&D in a net remain absolute to see both

million. million free quarter was the $XXX Turning cash to liquidity, of for operating cash $XXX flow flow with

with to flow. million We have pleased very generation strong free of cash cash been year-to-date $XXX see

for As Debt of in is million quarter, in facility decreased third million $XXX allocation was primary securitization reduction. million variable-rate our the capital program. debt we've on by previously in stated, a decrease primarily $XX focus revolving receivable $XXX XXXX credit and the repayments our comprised

reduced ended subsequent of to pleased $XXX billion. balance below further the the quarter close, to with its facility a report we We company net to quarter debt are the credit million. Notably, revolving third $X has

over the Now Q&A. turn let to back us who will call take me Dan into

we'll operator, to please Thanks, a to single queue of Feel you first please in get like as the a possible. Matt. to many yourself put we each with have afterwards through yourself questions follow-up and that, may I'd to work as if remind needed. With back to free brief question? question limit

Thank you.

Anthony Our from will question first come Petrone from Jefferies.

Your line is open.

percentage Maybe first maybe quarter. Thanks, be would on under and resonating at contracting an INOMAX are Thanks. a this and and cycle data Maybe the in on on see with update good long-term will contracts. Acthar, today payers. of INOMAX. of far least you congrats the a follow-up how the so And is just question recap what the on on be structure then pricing where just hospitals

Yeah, with trajectory regards to year-on-year we're pleased The the continue fact I in thanks this that that that we're anticipate With seeing mean likely product. for and the Anthony. narrow the Acthar, with trend to is to that clearly questions, declines we sales continue.

questions to with of trial, of XX% trial, well, of now in it open to XX% confirming That a the a is prescribers or XXXX. saw data things a will quarter. be that excess that the billion data very discussions to So of what we believe present one first label net the Acthar to tranche the again think the With our couple we're first with couple some at payers, of answer pleased reaffirm I information RA the is and quite forward $X to and portion questions. intriguing payers both because with we in that sales answers data helpful obviously now in very we regards to begins sets starting robust as of is are now coming

data is benefit. the all steroids. length to first benefit, of coupled are really therapy that maybe demonstrating likely of we're this also, by as Acthar, XX patients as know, show at is the Acthar. an introducing potential that patients of data And specific that will there's with therapy clarifies the refractory Again on weeks intriguing including for course appropriate targeting, multiple incremental And highly at the by for therapies to First are payers. regards that quite duration information that been of importantly, the And of has half here. with the least it you indicated a

randomized set that should including which the we looking As they're trial have sometime you of for of the again, the full first might half the the information data in portion imagine year.

data So of volume patients to the mid-single captured I and in of INOMAX, we're duration see and therapy. arrangement and prescribers grow regards given that what is trending we contractual as under additional pretty INOMAX, thirds as we've also see appropriate patients continue range we've type of the looking of accounts being of quarter feel Acthar available forward, think for to digit of of consistently well about forward in we very well. have things appropriate are there. going to there at with in proportion the the hospitals contract, the to of that look is overall, multiple what believe future two we we and that of for any said mean presented will INOMAX pleased to terms that our described. identify in growth some type But upwards to bodes With year, of sets well a pleased contract. on now into business continues terms And we help on we're very product well a XXXX a and some

Thanks.

Thank you.

Next question please.

comes question from James. Raymond next our And Elliot from Wilbur

is open. line Your

Elliot. Good multiples, recent disposition on criteria morning. that, follow-up as outright Lee think us And generic Thank to shareholders? process? you. be you an on the This could you update transaction meet is can acceptable some for still give sale long a discontinued? low how Lucas Given return operations can Do for

forward. as question to first in Yeah, of so our then a assets continuing range to ask all we've going currently of the Generics the alternatives Matt comment available Specialty those explore maybe and us second on part. that I'll we are your have take regards of With half the we're said broad to to Disposal and consistently, Group,

sale situation in the So the certainly at market or we'll whether updating a appropriate be time. develops, as it's option, that any other

else had not to have a transitioned into regard and XX-Q and report which but I would your we want would the I typically for that little revenue the if encourage under disclosure. years the look a Anthony, morning you talking we back increase have operations, coming operations. asset those with we point when happy years. more But you call around question with at discontinued back is ongoing XXXX, to the about somewhere, to would Mark specific XXXX INOMAX, this when clarify XXXX, three first relatively to go you and then it X.XX% bit in throughout to to of one Yeah, our XXXX you'll your just that see be go that file on that, roughly in year color significant contracting continuing all quarter, was anticipate I'm that contract to or a

Thanks.

Next question please.

And from from question comes our next Patrick Capital. Trucchio Berenberg

is line's your check line Your open. that Please not currently mute. on

morning. you hear Hey there. Good now? Can me

can. We

Great.

So a from couple I branded and have on of impact specifically Praxair's follow-ups INOMAX Noxivent. generic, the

trial at or inform you a Thanks. so, once appeal deals better Praxair their we why renegotiate it efficiently know such is hospitals that launching is And risk? without to that of to when plan permitted? launch cheaper possible plans set product there not if for the hospitals finally, do can Third, to for the shouldn't expect is the market? on First, product's and if officially hospitals Praxair it? Secondly, the is it about more version

there Yeah, on situation questions so the lot of with INOMAX.

obviously So as then. sometime have of in the in XXXX. we appeal trial expect middle occur we've of actual resolution we process the described comments, And would and expect now previously between to to our sometime the a

have to and significant, appeal, up here multi-year the were terms date we're what seeing next that up is Obviously risk, that's contracts have long-term at couple at the discussions point. But the out challenging mean, we're would the customers. the lose they some renegotiation, general the this for do not from customers to they a And quite purely them aware play we're with have interest prevent would that to contracts whole of what typically at and hospitals best that to to I doing so that be we quarters. would that's to launch in in regards seeing way it's or we're fact In set, are our not regards going But Certainly structured would to major in whether that point the suggests Praxair see to With in continue customers. that. Matt a signing could from if specific expect customers solution. some ability that. With There's them. INOMAX described to of again, do of us of unclear being trial they thing ramifications. this pleased with again, hospital's the benefit and as detail, to nothing

the drug we the the product again, totality continue general, a the very opportunity those marketplace for attractive service, INOMAX to in the on So things. the see of being all training, device, of based offering,

think new significantly will next mind to that on in change down which automated, more the cut also dramatically other error. device is thing could potentially we user the It generation significantly friendly, portable, I game. have in keep be development significant a human could more and more

to generic. if this the technology likely that So that lastly with I compete terms a competition significantly comes, is of recognize whatever final that pretty offering form a forward marketplace. the just that's would It marketplace And really in comment comes, when advancements not a INOMAX with move in to of branded lead. you would likely is branded we're leave is branded and separate it it be in would

about offering think substitutable that a would So talking that complete not important completely talking understand generic people with here. INOMAX. about branded We're really I a different we're that's potentially

Pat. thanks Okay,

please. Next question

Thank you.

Schott comes from next Our question from JPMorgan. Chris

open. is line Your

Neyor Chris This for Schott. Hi. is Chris

Acthar about stabilization product sales data. Following to up easy would think down given we I Acthar to efforts appear on XXXX? relatively efforts Acthar have of on one carry about into ongoing should kind follow-up your we for the and the comparison, expect year-over-year When And roughly you be the new raised then X% or growth to are well XXXX stabilize progressing although franchise again, year-to-date. commentary, XXXX, guidance think with

we for for analog, could results? indications. in do much. data, that on dynamics? commercial Thanks the that so balance a particularly up historically new good step new As I the to ongoing frame we've fruition, a that seen us payer Acthar or think trends data comes against expectations Is prescription how you positive help on

Yeah, certainly.

me there Acthar. your on questions take Let all

being we're and nor of of pleased we that specifically expect we to obviously continue. XXXX see while that sales billion. indicate importantly, giving would XXXX, to in regards the also again Acthar Acthar with with not that see narrowing did guidance on the overall also would But sales on we we So we're excess business, net this $X quite trajectory declines trajectory morning

at this going that pretty markets So next good point, gives we of data, idea regards we the over Acthar think few to With and the I how see quarters. recognize forward a way our think trials with of clinical clinical about now seven we introduction this recently trial. have is in the that the run, the most long uveitis a total initiated of

have and data in about growth of indications, we plays it will seven for dictate long is market, ALS the the that trajectory, trajectory trial. we I'd the which going are trials think Acthar the in And out the have for labeled run forward. So way six then how clinical the

if there's again patients, offer potentially low we've the opportunity to addressed clinical those couple designed those specifically not on negative, probably product growth refractory all given those can if we it's a that are trials say with used of seven time. most can think growth fact Acthar patient patients volume. the payers, are a plans, positive, a relatively to patient of But penetration, Acthar trials where at being subpopulations prescribers, highly today, benefit. I for look over the safely are that trials And significant based drive

the to on trajectory is clinical next what Acthar the months of going future XX of trials. the over really And XX determine to really be based to so growth outcome able the we're of

expectations to say The with guidance well driven only Acthar significantly by a came like in where was in other our guidance quarter raise had thing really and around to I savings business business year. line are Mark's in that to the is the opportunity Acthar. increase was hospital comments largely is we suggested as had internal What add I'd really this strong that the saw as would SG&A we you the this the morning

general. data make believe clinical just evidence what I'll a Acthar in We comment final one is that weight on strategy. we the of information call And

continuing prescribing robust data clinical be there's we're that in of but quite patterns that to future overall, for evidence the single going probably believe to change likely a time sets, make fact the increasingly trajectory. So positive produce that's over to set no step weight the is drug's data we

Thank very you Great. much.

please. question Next

Thank you.

from Our next Buck question comes B. Riley FBR. from David

line Your open. is

very thanks Yes, much.

a potentially VTS-XXX, do the to on looking know color question it in maybe was have be maybe for, XXXX the might data just bit So XQ of XQ or can anything, been? you my follow-up values you – how ago? totality And able is to terms one on versus anticipate a XXXX how prescription changed, and work? length versus you give Can quick Thanks. think have of close is what on And FDA a XXXX more I more if maybe you trial file that badly this little do of P what that is the miss then do or you some placebo, in Acthar. might the do in anticipate but year clinical you talk about you'll

I'll back bit. come and Acthar Steve I'll and VTS questions maybe ask speak the to the So on take to

with on because share now we're going patient so with looking average I'm still to placebo data. pretty trajectory treated exact well on with groups the VTS, Yeah, VTS-XXX not you those was the weeks of will P But right at treated over as is value of tell as that flat. XX what those you the both I

from trajectory that they were of part a not cohort a better did is patients did is words, including show were neurodegenerative a severity comparison the patients matched that longitudinal and those condition. disease population who than longitudinal of this did from followed age had patients been other surprising progress. they the differently. And other of treated in studies by cohort. did The who a with the There have So NIH that study

bottom both is line a also to expected we So did separation; we We the expected decline. see either. not

both and weeks. of the patients XX patients the stayed same over placebo-treated about So drug-treated course

placebo the patients we a good understand argue thing, remind Why what in just it randomization I'll can a you different as X:X placebo group. and you, patients XX but Now randomized. progress not was to have that's did these anticipated? was were

more It we a So the could three-part study. that was of perhaps part we C have glean information from trial.

on look The finding; I and control first label those and the study course was and any part that label was portion We if need you; gradually treatment that to who versus third of placebo. a the period in accrues treatment. the difference open those part the on on described open on drug, which stayed randomized treatment see drug drug, part dose patients it patients stayed to of there's over started is who the additional an had second at

data all the yes, look totality package whether as agency a well look We'll look a at been mentioned. the at substantial not we as of about We're the treated who compassionate a patients as we have the that we or of the to to reviewable part large data. this C of problems. through a have conclusion before at come I use to NIH actually Regarding of number data to That's a present additional going have data, amount to opportunity

significant over we why a there's versus I open supported the question with RA where specifically not speaks expect see we for quarter patient, are those open pleased trial, prescription in the might patients, those the and and Acthar blinded prior answering trial, half for should a ways the takes consistent important that's very again data length you patients to an you XX the type way you both XX also phase, before of first of in I regards another over weeks? you question and/or label that what with with is put low RA David, in is label keeping in going weeks. by XX other designed really benefit? us you're how treat to months Again, on withdrawal the affect the XXXX, will of the of a that long another are prescribers full responses by that least think specifically an which, the additional refractory is patients second is and patients to the So set's accrue. know, that's are helps where XX% benefit once highly change disease would at the to the refractory RA initial available. prescribers treated about what phase, XX% that that. to your again, an prescriptions the as in additional portion if benefit a see onto XX%, of patient need weeks there you payers on scores trial been question believe the the in of to we moving withdrawal But treatments with we've to And do seen pretty to of encouraging And question again payers length their help sustainable say Acthar Acthar, these activity couple and weeks, which And XX and accrues it the for a see address ACR trials many portion answer patients think

Okay, great.

Next question you. please. Thank

Thank you.

Fadia from Leerink next from Ami Our Partners. question comes

Your line open. is

for I the have morning. three. Good Thanks question.

next the Firstly hospitals may or may with to prevent why bookends contracts just consider on show the to the litigation, it terms placebo on progression between of to the contributors the sort of once regards the patients device did would with some potential not And look help what help the may of you generic could steps INOMAX, product? And for? part exposure that may and you that have do severity the of some selling of trial? or renegotiating business? the maybe of for that Praxair on be of And the you duration of what your or arm what the of disease something that then the just we Secondly Thank should structure launches? nature regards us opioid may of from Praxair on disease? trial VTS-XXX you. the side, could differentiate timing in your dissuade with the put it of in enrolled your Is elaborate were the you difference be and

to know lot people got are Just we've you. one queue. try keep question. to a a Please quick reminder. Thank it let's of in I that

With the business Group, could Well, Specialty these I'll quickly. we to in Disposal certainly through tick relatively sell Generics to the parts. regards try

whatever going front timeframe this what length us at considerable early exploring be being litigation, are exist. public any those it's to I we from of fourth of time too the It's the something to way to likely the for there XXXX. really the out said, liability are point kind of of continue are that see think not. likely to would to With options trial quantify of to in of likely of if And or of may Again, of in take quarter I strategic piece and is understand this we a start those just information extended we regards to very first kind timing, potential there's there translate that. cases, as this terms be our have may exposure and process. opioid a the to that's end play heard whole long, think that a As towards is forward. that that believe risks in and no third, range first I of all again, minds, three in will way pursue those,

several would device we've if it what is has terms trying A let be than approved know from INOMAX Praxair has of known what were the market, INOMAX the do may whatever less be what between the me know what we device the differences sophisticated today. and approved. was INOMAX introduce what don't past, first to clear, device been get INOMAX approved, on based We they dramatic In and and to difference might device. generation what believe next really the well that And in structure today. offers be then would contracts, that's step elaborating evolved what Praxair of the we advancement another while device, don't of typically, technology, of on be Terms we the those significant contracts, the of beyond details give up incentive up for attractive typically volume is and of customers. are some longer very or those the what certainty term makes unlimited typically certainty, type it volume. cost to sign for for volume economics customers And signing generations

Steve So questions you couple of to had are VTS. I'll that first those comment and on the ask

VTS-XXX, to think so couple remember all. regarding a first of Yeah, things I

amount fair interpretation of the a balancing we're gotten of current from compassionate from trials this that previous against data and study. we've use So

been So, for we're can evaluate. least where, that particular there at have a place number an at interesting we of this databases product,

keep up Now population. patients this XXs. is anywhere The also, heterogeneous a ages in X their enrolled mind to in were the from study early

in heterogeneity is presentation. there So,

understand but You condition, patients up we hard typically at an that in looking is most we what a to as bring groups, is assume be progress placebo randomized you group very study now drug didn't a a point. We're very is ultra-rare benefit will the assuming because right means so anticipated. good have heterogeneity across of balanced are that why small placebo of this that that there which

we'll like severity of et age onset the extent cetera. the well things at the time their which consequence of disease, of at a condition is So you look neurological of the disease, as of of patients disease know, the

number we a a assuming So process want have placebo may in group be weeks or want of there say Hopefully, months. But of do not to idea clearly, the we're we'll and good in very that. we're did benefit progress. why to I understand the now right evaluating

Ami. Great. Thanks,

please. question Next

you. Thank

Stifel. Our next Samimy from Annabel question comes from

Your line open. is

up my Hi. follow question. wanted VTS-XXX. just to Thanks on for taking I

heard able length sense you And just next Do to the appropriate Thank had as of trials, use at months. have assess four or extension of trials I timing a of progression. And that been some and wondering get may long be long duration trials of disease relatively will on compassionate booking to some be to on that? So, FDA want periods of you much comfortable of the these in how said want was of sense better and have FDA these for been to the patients who've the – you. years. as look on you with if time. weeks the I've a

is Yeah observe United assumed, an this, XXX small XX-week in as so not for the and States. we a things. a period the in time Number of have That couple about affected, well, unreasonable perhaps a an being differences. are as of population condition was ultra-rare It's you one very period potential or has such many agency to always population. the said, as XXX learning as that patients

So a we're very talking rare about disease.

we that all So look to of data. need at

is data of You persisting. right there treated with been enough now were have that several for is many as drug of who absolutely other in the a benefit patients from patients data suggests well, Interestingly sources years. those

and all regards completed we that with to look to at and have some the strategy data we inferences and totality to make sources, of at information going we'll decisions a just look the the trial do have we So understand forward.

the We months. several over will this evaluation conclude next

Thanks. Great.

please. question Next

you. Thank

Nachman next question Gary Capital Markets. from Our comes BMO from

is Your line open.

have most much update SG&A next feel And morning. we it quarters? of is about how efficiencies then Thanks. improving, has just next for if Where for on how think been and room run Thanks. that year coming visibility several access should the there Matt, for has given from? Good cuts how that the On net you trending have more Acthar, rate been quick cost an coverage and pricing appears on guys that. about been formulary how you

positive Acthar. future that modestly first be we that forward. the expect point take Yeah, Gary, net price. to is about consistent changes Acthar by spoke in regards again, we two, to said growth and the all pricing, With with this formulary on With not what would we've year, so net we're significant earlier. I'll price volume, to at as not regards driven a any And coverage, little bit look we anticipating

significant XXXX. and again significant amount anticipating we're XXXX. which we've already that as for anticipating we of have customers we a sharing to we keep clinical unexpectedly Of point, expect this would What dynamic the and course, change formulary as saw in emergence not began changes some we very is payer But of occurred our are continue. at of a mind with any data dialogue look forward in is marketplace this

run would regards this question I very what I with rate that. quarter in clear with to delivered SG&A, Gary, around Yeah, not your we it. and be want to take

that other well, into We a we're to launching host we're be of a XXXX products innovation we going as invest. initiatives investing We've so number got and of in to digital are areas. going other to and as need move

was million the release, please about take to drive you'll a took the did $XX and We But some of a saw but you've script moving the is restructuring. out, launch remain committed early in I'm got I what to this years would investment in sure quarter because benefit to the as efficiency that we coming next we we've cycle. for that in that of taking XXXXs that see morning quarter. number use the this So quarter that up and run a not forward products did $XXX charge the do just what and in rate knowing – million from we we said seen which have of in echo in it set we was

Thanks.

please. question Next

Thank you.

you. Thank

from comes from Our David next Amsellem Piper question Jaffray.

line is Your open.

Thanks.

Just a ones. quick of couple

had a a regarding on couple what's only in setbacks price And assumption Praxair that competition? the secondly, market here, setbacks. to extent pipeline of working the So is your is degradation the and you've INOMAX, then that few pipeline

going here to are Thanks. approach that or look development? the are continue And business So just different aggressively cleaning I you you taking to guess you a going structure? different up are to the maybe to on How should capital focus is, a are think question approach we forward? or about going thinking taking you about

we're to significant able I that's confident customers. be come, on I at to rates. and we'll historical to a coming, And that does what be feel remains competition are in If think quite again, competition pricing, or regards with retain share. so mind, that quite of amount when really may we contracts from seen. think be Yeah, seeing really above of long-term renewals based we're yet seeing basis that a Keep customers on aware

earlier. come how year bit the the think or want is offers carry success do of is to something But things would at readouts failure volume. is looking does with what back out getting we we risk things regards from competition and think feedback and customers that that INOMAX price we'll offering of to more a pipeline we totality when and pathway play say So so, see as the next that you course what of a value a which are coming we've about is And to of population. believe ways. again, or them We if most lot developing as terlipressin a think couple the that particularly as is that as we see that portfolio of do. we couple to in It VTS pipeline I StrataGraft, and well. With stannsoporfin like over our about the as patient in happens it the think there's we regards the companies a just way so evaluate fragile this pipeline, really But a our and in and we're little step heard, been ourselves, particularly of things out. on play forward potential we're

in our going in development primary been of we'll there product in we've be enhance our enhance opportunities well while allocation goal multiple and important whether going successes we some are capital pipeline we that, successful we So on shots at too With this call there failures. like going some be any evaluate But very point business believe reduction as our And it's to early development, are think pipeline to continuing quite have is business additional to we forward. and XXXX focus that debt to remains to successful. regards continue And doing which as pipeline, those and not our that or to it's do. way line.

Thanks David.

Next question please.

you. Thank

Our next Cantor Louise question Fitzgerald. from from Chen comes

open. is line Your

for my Yeah. in This Sudan Louise. Thank taking is you for Loganathan question.

I predominately pipeline bringing internal areas driven are company the is, is if through question the assets And it's current the and development? new why? have commitment next driven increase latter, product it or is prioritizing by decade over by to the R&D the the which therapeutic So spending

it's so Yeah, a actually mix.

We brands of So and like all for those generation in. know, label, brands we to in-line you well programs late the value want also evidence as cetera, proposition we expand in data bring phase support Therakos, et the as and sets INOMAX, in-line expand in, a products. as those and Acthar invest

that where our design Mark are have cetera Phase is are suggested. what do the the their those issues really our opportunities that the to versus sweet Xb/X CMC methodology, us just in at pivotal would So the looking as to is spot to both, continuing well and to see towards think we space going knowhow Phase that X in be more I apply And et issues, opportunity trial programs, into bias already programs Perhaps resolve programs. a programs. I

And interesting on an think therapeutic as is your one well. question areas I

of severe company Clearly by that may patients and options with critical to underserved in expertise really afflict certain to focus address develop neurology, is who our is diseases, challenging you And with. those can that few for of focus likely are where faced area relatively pediatric another that areas us there additional potentially going patients forward. we're underserved we neurodegenerative the Hepatorenal diseases see specifically conditions. as the the pipeline have mean those patients. already such they're therapeutic So on

we pipeline forward, have forward, going things and bring So those those are where and we have clearly areas enhance to in opportunities a opportunities couple we're additional expertise, believe already going already of that in. we our those likely things

Great. Thank you very much.

Next question please.

Thank you.

from comes Our Morgan Stanley. next David Risinger question from

Your line is open.

Good This Chiu is Dave. Thomas for morning.

about you pipeline Just think just the talk that you. question. most have investors? you is underappreciated asset Thank Could by one

several. think I are there actually Yeah,

late-phase in development, terlipressin think very I is interesting instance, really a For compound.

United and critically States. the and is very X, standard you is targeted population ill it's this As care know, product type outside syndrome hepatorenal of been for of treatment a this

two to the four exacerbation weeks critical their they in is experiencing this this patients to to, when are manage survival of go median these So product actually the condition. is range physicians that of whose

we actually the chance and that we establishing asset of actually have we in efficacy think study. undervalued So think good an current is a the

also in a innovative acquired then some we displace, patients. very much but that tremendous with And cell smaller ammonia is We we product a program, That X know This and program, can Phase Ocera, too lot to the we work effective. have is in that Phase about of patients haven't company, of some out is a product, we've skin product StrataGraft and we're so and actually and interesting gives you and robust that associated inherited which here X This product. hepatic and a heard improvement. think that cases, iron line another to effective with disease, a is or actually ammonia next speak is could liver it, the condition quite a us might encephalopathy, is very very confounding that creases own clinical that with Phase is confidence with of one. in some data cirrhosis That advanced in producing good a have that autografting. I doing a we patients scavenger. well. in the remarkable mechanism clear we reducing another forward use a to allows recapitulation that have going very the patient's year X move that really benefit been of us that's as And initiate

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experience we're likely moving some to and expertise evolving Thank we're where area you question. an forward. the success that's think I So for

Great. question. Nice

Next question please.

you. Thank

Our next question Sachs. comes from Goldman from Dana Flanders

Your line is open.

quick I be XXXX, the quarter? And you that you mean the just $XX follow-up. Acthar? to line and million and benefit Thanks drove about for in can then questions. formularies, What Can a this for the just could Hi. you. income what just know that Thank other guys. starting volatile speak maybe indication-based thinking you're just to for Medicare think I changes how

lot healthcare a changes Yeah, that are system evolving, in so suggested. there U.S. it's of obviously are how with regards the to potential being the and

D at payer appear least perspective, it recognize to Medicare opposed Part Let's initially some as public a least B, at Acthar, from specifically for does that under Acthar; is of typically and are around focus that at point things couldn't change appear around D, point. the to focused does mean things the but B on at are this B. be proposed Doesn't being this

room clinical always be Acthar can changes reimbursement I refractory way are think think our we is is we in in on that's to the and that why think of of process provide to longer benefit, that generating value highly system. patients. is it the healthcare we those of the data, patient products And important term, on types to clinical that That's focus think the most U.S. the the innovative for specifically come about regardless why data whatever system importantly there the so reimbursement demonstrate we're most where going

events million, $XX income I'd With that non-reoccurring. out. and other that does are are million the to stand say regard about your of question around $X one-time it

well in of had the our in over You'll true pension our as position there. up Mesoblast see the and eliminated year in disclosures we have we the course last

a So of product the by in non-recurring. of is have royalty into a about do rest going $X anticipate that next royalties that the is another million you see that some The bulk forward. is we portfolio in is being Lutathera year that volatility line company. moving which so item sold will We

Dana. Thanks

Next question please.

Thank you.

Our from Jason America. of Bank next question comes from Gerberry

Your open. is line

my pricing Jason. follow-up question. Oh for is hi on the This Chi for thanks Praxair. on for taking (XX:XX) A

versus you And launch, it Thanks. having the the the for Praxair of on to market? premium pertains generics? to room to Canadian as cut an fair of sort lot be to Canada As it comment would price U.S. analogue introduction magnitude Canada pricing think less can of in about a generics the prior

ability Canada way the the competition simply into all again, it's moment exactly clarify, basis. province-wide present account the with a of what whereby for account. with actually see to they province the cost work the much to a that be of use a our customers situation environment it's so a in expenditure of customers, dealing see be And branded contract goes We Canada, fashion. actually the the like that think at kind analog system; at Canada, want whereby best. the choose U.S., is INOMAX. we U.S. much U.S. options things Many a so would have generic. tender you we differently nothing Canada and environment what would INOMAX to of a strength would would an don't competitive model because the can them we competitor. the unlimited a to branded by offering in have largest Others just competitive that level. or a target be on pick the it you that's is maybe And in a based Yeah, a for on where hour one pricing is is per suits not a different defined things on great in example, we're for product In

the pricing we we works a offerings decide product to occur, for up their anticipate would And and provide that of what would versus customer of so that individual And really best would accounts. competition competing options that competitive whole each branded we one to when have that commensurate those again, the and a with are be be if would comparing space does in range any offerings. we we and

through (XX:XX). them Thanks got Operator, quickly. Thank more you. questions. We'll for a we've couple to time Chi try go

Thank you.

next from Our Genuity. Steadman question Canaccord comes Dewey from

Your line open. is

marketing still about. Hey. postsurgical interested In Thanks in pain of XXXX on And you reduction LOE? that dumb for with post-ops, had sort or and squeezing Acthar. that with And on question I you can me the the evolve $XXX million in. a guess will how been detail a your are remind presence there us of talked was space? OFIRMEV the currently then

this how give trial, Is looks it like? systemic what uveitis administration intraocular the some is the For maybe does And study work? an or detail Thanks. just injection? it on

so the predominantly to its future. but uveitis life will anticipation end the we the as right footprint drive of believe in cycle, commercial the hospital, in critical trial near be Yeah, ask Steve in terlipressin we such that products comment on of care space in hospital first also We to through let OFIRMEV design. the the questions me take and have both promoting

OFIRMEV and hospital that had there. with wide-ranging today certainly With that and very with in hospital our expertise setting. space, consider line. to we for the products to down appropriate have given we be Therakos would what's have commercial postsurgical our of we've for up set used we're the expertise in are continue pain So But coming good have both regards we that INOMAX the and expertise, more to portfolio anticipation into success

hepatorenal are there innovative probably see that opportunities forward, in can postsurgical open focus severe are that the pain consistent be would with and and primary are objective space, of But are to critical that. less to And pain so our did patients going areas this if management. you as in hospital in more certainly we immunology that our space, space, so the neurology space, extend

Yeah, and just very of briefly, injection. so other local twice a many the subcu uveitis treat; study it's is a done like a not conditions the week, with we injection

time Dewey. for Operator, maybe to and Thank wrap. have Thanks then question you. to we'll one have

(XX:XX:XX) question our And you. Thank Regard final Mizuho. from comes Steven from

Your line is open.

Hey, good morning.

$XXX about color the progressing quarters XXXX? maybe few briefly And million? is see Thanks. still AMITIZA you on next your on for year, really some it into over that can you expectation Just this provide contribution how

we synergies on capture with significantly what strategic that we actually, mind a and that expectation. cash primary AMITIZA. so and for that The to Yeah, are than very deliver see than pleased, top the we've greater rapid Keep it's objective expected. was flow, bit diversifying AMITIZA the we expected certainly lower in more with able cost been are but to we line delivering is

is this marketplace to very So competitive. be a continues that

growth, we this term We which a greater generation. of satisfied there's strategic we're flow have again, the was particularly experienced likely reduction delivery product Japan. cash very expected Japan. with in And in think Longer price than diversifying

very everyone you this like everyone. I'd for thank call morning joining Great. to Thank much, again. the

a have. on and also replay of available be to I'll the the day will today later be reminder, the a call questions may answer As available throughout you website follow-up any

So thanks, and everyone, have great day. a

thank and does conference. the for participating conclude in you program. Ladies today's This gentlemen,

all disconnect. may You day. wonderful Everyone a have