Mallinckrodt (MNKTQ) 6 Aug 192019 Q2 Earnings call transcript

Good day, ladies and gentlemen, and welcome to the Q2 2019 Mallinckrodt Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Mr. of President Vice Speciale, Investor Relations. Daniel may you begin. Sir,

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

Joining are Chief CFO; and this Reasons, Dr. Bryan morning Steve Mark Trudeau, Romano, our Scientific CEO; Officer. our our

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

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

website adjusted and A the financial and non-GAAP channel We to to mallinckrodt.com. a We to release, as website, page adjusted Relations Investor should important our measures on distribute provide measures for reconciliation is these can you our will of performance. use available in which this our GAAP earnings website selected information. our of information, found related be company look our time-critical to also

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

that, noted Mark? range the each Mark. With per as of per share first the earnings we recasting measure, to Given the to let of our are to call guidance me the over annual $X.XX $X.XX and including the the raising year, half across diluted full segments in the press AMITIZA guidance turn share. performance adjusted for updating release, year in

well. the building strong branded deliver growth Once products Bottom and straight a Thanks, year. and across flow consistent enhanced further generation line another which the in to by to our as again, very significant of Generics a solid performance management, segment pleased cash QX Dan. effective good was performance by growth. quarter while on start diluted growth We're AMITIZA, by driven our quarter, robust delivered cost resulting was adjusted Specialty in second and in resulted hospital performance very EPS portfolio

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on for development four, we critical We While surrounding and very the far. external challenging and environment business patients uncertainties underserved performance into resolving commercialization pipeline remarks, completing began by the external an priorities drug to our of the as as regenerative be our let to pressures for and commercial ill portfolio. nitric strong related generation developed us Two, limited options. hospital executing separation. increasingly for already We've prepared We've promise of along began possible. the technology objectives. generation. with in-line towards spaces, created patient advancing made critical allocation further pipeline. disciplined resolution to these continuing and robust issues pleased of innovation-driven thus many priorities four XXXX. needs believe recent outlining business, of brands We an uncertainties, service flow and oxide, therapeutic including enable Three, And capital be following the the net products, We'll remain to products and should to One, legacy throughout market transforming in intent autoimmune achieve great focus. with transformational and care plans are our strategic the long-term debt often platforms we tissue meet enhanced particular, severe and of ECP reduction, company, look the focused primary but the data deliver maintain our progress forward our with our cash eventual Specialty suspended while capabilities operational currently leveraging diversified rapidly with growth late-stage first continues to customer conditions with strategic In establish on that critically value discussing care, patients, our company me conditions. the in maximizing all development separation. year strong early the on our in the have with We strengths, differentiating that Generics goals to our these the address

for biopharmaceutical outcomes underserved Our innovation-driven company patients focused remains and long-standing on an conditions. severe to with improving critical goal be

However, uncertainties previously the announced increasing off its suspending market opioid plans based is now the by the Specialty including current on spin created company. for Generics conditions litigation, to and company developments,

market We with consider of updates a options previously actively continue to separation Specialty range business, consistent our to of as to strategy Generics appropriate. the ultimate lead intended the and we provide the to will stated

our quarterly with billion continues Now platform to starting and our sales. net $X which to move portfolio, results, let's total be operational fastest-growing largest hospital in

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service INOMAX, differentiated at sustained consistent model. be the deeply more by Looking demand driven renewals contract continues to long-term products and by growth total fueled

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to Turning Acthar.

performance, discussing important understand near-term key and vision to objectives our this long-term for it's product. Before

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the see expect back half to this sustained year. in of growth We the segment

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I'd greater than Mark. our made few a billion take $X.X to like to Thanks moments in since regarding progress we've reflect taking Acthar the investment on ownership.

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potential portfolio and did is light more advancing assets regulatory forward, this of determine updates of those assets provide as The asset. opportunities, we development we'll valuable investment we appropriate. of our While -- having a path those as pipeline and clinical are discontinuing of rest portfolio in

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We who Directors. their it us an complement over financials. to to these expand joining to also Board the through happy have that, components. We're of to other be target Bryan? take off start the two Bryan let and I'm option activities also With turn enthusiastic me to will

Thanks continuing AMITIZA the per diluted segment operational the performance adjusted and XX% quarter Steve hospital we of prior of by second year share and driven increase the reported In Generics non-operational the good and an reported everyone. morning products, for quarter, XXXX, benefit of of recapture. we to to $X.XX, and over benefits million associated $XXX and over million both generated business delivered earnings Specialty Generics million in X%; flat increase quarter expect collectively Specialty segment net net in net the $XXX net with allocation quarter, generating a million. net in in The capital provided for sales $XXX reducing interest prior this share $XXX up of the million X% sales, Acthar X% strategy the to prior up contributing Specialty in Therakos debt sales, focused the with our period X% segment of growing that sales net were $XXX a on $XXX year. were sales, the in be in in net million OFIRMEV sales and expense. sales still million products net near million Brands and the sales X% million $XX relatively Net a hospital sales sales $XXX increase; $XX year. X% net $XX the INOMAX million AMITIZA increase. from contributed

benefits increase is was both sales and percentage percentage XX.X%, which expense sales opioid-related spending our data sales me the Specialty basis generation of the progress X.X% XX.X%, including a Total company slightly of and let by to down the legal for half a towards reflecting R&D XXXX. net and net was spending offset gross quarter. of We to heavily as on acquisition more measures of adjusted R&D as compared efficiencies, segment. to percentage restructuring Brands synergies we percentage a absolute a profit share second on XX.X%. net project at weighted company of a percentage operation Overall, total as pipeline in as R&D as Now sales from XX.X% increased SG&A company some was operational details for spend. compared net Adjusted the

cash strong Turning of projection with free in the to flow of having $XXX respect to We're in operating third of cash with an liquidity. million six in free well ahead months of generation the $XXX delivered for million free We generated quarter cash incredibly XXXX first the flow $XXX our flow flow year. cash million.

million pleased by our continue able we with to flow free our reduction cash utilizing year, ability be capture beginning very debt debt. our the in Lastly, discount since of Collectively, execute $XXX to the nearly been to repurchase fixed-rate on to goals. debt we've

We the coming and potential we XXXX are this of have address to April mindful maturity. alternatives are due in evaluating maturity

lower at billion, notably of in the net debt is in will $X.XX the since June. net beginning was reduction X.X year, materially our of also the million of of net of And debt continue end Our end times our focus level lowest primary at be $XXX XXXX. since is leverage net debt debt June our XXXX. the a reduction which allocation capital to Debt to

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

Thanks, Bryan. please we first [Operator operator, Instructions] question? may have With the that

from Our first Wilbur Raymond comes Instructions] Elliot [Operator with James. question

You line open. is now

as Good on wondering if pharma you. occur? the a Acthar Acthar. morning. the impact for Lee have shifting you catastrophic potential Wilbur. Part were coverage question This trends, changes to to currently to is Thank opportunity I Lucas to I Elliot Medicare had XX% proposed was to evaluate if on D of related such directly

to you beyond. in that important to few just It's Acthar, of either But to Obviously, and greater pretty some potential then many expenses proposals be can patient relatively probably fore the Acthar to care difficult a would Lucas. such say evaluating changes made and have others think patients already have enables a the to we through like that the any The again out-of-pocket would of Thanks, health system. the of proposed patients to as or that overall. that that likely the to what are better care the general, general months net throughout range referred treat is to other access if is rips products any one one come are to certainly business Yes. to the whole positive. expected challenging cycle really several like conditions, and would Medicare limit anything though patients have access be system we proposed and In those next nexus U.S. -- to speculate we some aspect whereby potentially D or Part products limit the patient changes afford system. may proposals positive net be options of to be health to

Great. Thanks, Lucas.

question Next please.

you. Thank

next comes And Cantor Thank Louise our Chen with you. from question Fitzgerald.

Your now line open. is

Yes. This in for Louise. Thanks Loganathan for Sudan is taking questions. our

-- kind So headwinds first be that assessed of on regards in hospital you question, growth forward be next expected factors driving the we suspension to of the regards -- it have how XX then primary then time months? and to what line that XX of the will And forward? negatively to is what's And any that. going is, the -- the sale do category for business? that are the the And portfolio, you spinout, Or near as there could secondly, for option then in term? in how then that expect look impact there is in primary

those for questions. Thanks Yes.

performing quite to are the you the to demand. regards that trajectory we we pleased hospital driving be simply the and anticipate year. the high likely growth to Therakos. has of business continue main performance and for business. would products; really that collectively the balance with that Primary might INOMAX across as It's business three demand factors portfolio is our in OFIRMEV, the in single-digit been continue The range So of with imagine

outside demand underlying greater the particularly nitric main pain managing With associated NICU. its product demand, kit which for to uses in of an on side, the On ways at use as ECP regards with of patient U.S. of traditional other Therakos it's oxide the particularly pain surgery U.S. for of it's the underlying to analgesic of the alternative it's CTCL OFIRMEV utilization is infants as of And utilization an and managing opioids. indications and in INOMAX, risk the for

to the of all have So the With with regards property primary demand we OFIRMEV is an a end exclusivity, XXXX. drivers have is to Intellectual are that to primary collectively and driven volume likely into property which our appeal of considerable. with of particular intellectual known pending occur at of again product XXXX we XXXX, And loss December regarding course, around regards headwinds, offering. driven. INOMAX,

Some time, been property of that would has that have of to that but challenge. certainly longer. even expect resolution challenged it we're a and progress appealing And could any intellectual we bit

near with the longer address to are in those have our in is continue digits. and today very that be So than the engine we growth our business. we business number to for term comments, And high growing business as Hospital be the importantly of hospital hospital we pleased pipeline $X billion primary but headwinds prepared a that the And products specifically in business. single our said long-term that company greater overall. we've expect would both

that question Recognize what today second suspending spin. we're announcing around is the spin we're suspension. Your that that's

is Our these and strategic them businesses sooner to later. intent than separate separate two

considering last we've the but that those couple simply of discussed of the which the transaction So with other rapidly a that things options to at all spin over that time move revisiting not at include all only suspending not we're time. separation. towards conditions moment, fact spin given the years. market ensure sale favorable whole move that range and this would of the the We're We're to forward this at we options, are

Thanks. Great.

question Next please.

from Thank question of Gerberry America. our next Bank comes with Jason you. And

Your line is open. now

This Jason [ph] is Ashwani for Verma Gerberry. on

around the update a Acthar to So uncertainty. just had related about question the

that terms pricing? on we so on tell to what respect around getting CMS with have mentioned [indiscernible]? Acthar uncertainty happening you where full lines, reimbursement is has August front in will can Or And the And it just Medicaid reimbursement is to I Medicaid time provide color the that understand the intensified? trying something is on time? stuff. like, worse you Just related to follow-up to is the you of Mallinckrodt the that think dispute more on

Yeah.

take me unpack kind let of So all them. of and these

discussion the moment recent the trial With price of have First underlying was price Medicaid event did or separate a with or a sorry discussion front Friday. with regarding to dispute Medicaid is judge most that a at CMS and CMS, Acthar we all, best trends. on the base the in of hearing from regards

of As we sometime to in performance hope And of the would sooner greater happen by that clarity this issue will comments, mentioned have certainly prepared our expect end than we end the to the later. have this of we Acthar outcome the would the hearing a that that resolution But if would would to on of we prior month. matter ultimate underlying And we is year. again trends. you hope separate

the very we're see Acthar refractory clinical on side response with RA we to So good trial what the the pleased patients. around data

of the consistent that We when recognize we've the typically the on from this historically clinical most and we've We data primary is at of data. that produce differentiation and see and with volumes able category strongest corresponding in measures. what seen presented many that data that's clinical secondary are increase clinical been into prescription in data point, supported placebo demonstrating prescription measures, on by to that And robust trend volume significant particular specifically new uptick market. is significant this seeing a clinical piece

refractory important dose very of because and patient the contemporary in a for type speaks RA patient both and study. data duration and and strong identification the gives it to prescribers specific information payers, information specifically large again on and So, very

the earlier is two pressure the seeing reimbursement very seeing positive we're we're ways. area already The data, year. was in comes clinical again impact that So in this on And that area. revealed which reimbursement

have some speaks that just new pressure and issue time And of scrutiny both with on those general And -- specialty and on downward as though, the much pharmaceutical and mentioned business. both new Collectively by payers. we patients, over separate pressures in the that to why near Acthar of reasons at reimbursement look the today weaker we of guided expect we that's that we half going term, of we're unlikely the the full Steve's to exceed is more back sales the for that year clinical sides around be seeing one and seeing in net first and we what's to we're heard to have of We returning pressure and XXXX. Long-term, year sales trials $X that billion And independent patients. comments, products CMS, it both in we're than of and the out. on set pressure we're that uncertainty you pressure we're a we going at half look however, read are returning and our of CMS. having number on

syringe We presentation clearer the syringe new prefilled in device, over would long-term as yet have self-injector if we we once much have developing. self-injector, months view the the in of are perspective a we'll for approved the that and prefilled a a And to next new have out, as a get marketplace. all this information another XX Acthar anticipate we reads that potentially XX months the enhancement we label is data

our we're prospects pressure, about Acthar. a led which reimbursement that, Short-term, So to we long-term in experiencing optimistic to today. of significant amount be change continue very on for the guidance

Thanks, Ashwani.

Next please. question,

question our comes from Greg with Thank next Fraser you. SunTrust. And

Your line is now open.

Fraser Greg It's on Acthar, you. Thank Gregg follow-up. of for Gilbert. a On couple

issue. expect On Medicaid that you that how new then the you influence data to when a could And the and can quick And coverage comment follow-up on refractory on just the happen? indications, the you RA now? have covers that

what do the to rebates? from offset you the can case, you lose If Medicaid higher impact operationally to were

Yes.

we recognize authorization. regards with coverage call is RA indications So that label to Acthar for prior virtually on what all

no typically coming the In very that we're a is data, if there. no change the coverage level therapies a more this payer typically about there around are we that in while you very if it's we good response that multiple having reimbursement for which these clinical promising data to with that's we new before alternative What data, early focused see it process Acthar specifically pathway. Acthar present we takes some looking pathway the but and is at seen we're very is authorization is really specific initially change are what getting will specifically determine its prior very And So, initial make time. potentially for on conversations through has pathways pleased at patient What level considerably patients. RA There's bit at that could different. when to payers Acthar. tried easier words, That's have prescriber to at reimbursement positive this stages. need refractory demonstrate in reimbursement to to failed a other get physicians that

So again, clinical time. yet believe yet that would not of data up that's we why impact positive anticipate We would in the that take that don't sales. some showing net is this

that here AMP. very call that's in think case So by general base for our because in regards to if reason some have should against is the that acted they goes we that. strong what But other date historically we CMS, of way we applying exactly the we think all, instructed about judgment with how us, the in in certainly, appropriately legal have as first we recourse CMS

look coming from of investment first that things In we that there on certainly round. be we be offset clinical event very you've we are go of for way. the And So of outcome from in any experience amounts data presentations Acthar to opportunities trends very, any cost outcome we route good to But us in that new regardless might were to in that I the stewards certainly this prescription of negative long-term as something for CMS. our choose basis term, and quarter. importantly, CMS, if the us additional or continue it's have in the significant legal significant near the near our offsets a Acthar pressure with seen at term including whether would think downsides

you. Great. Thank

It's evident in our and guidance where we on bottom the raised bid line.

there leverage throughout that. So P&L to are manage all the

Great. Thanks.

Next question, please.

next Samimy Our Annabel comes Stifel. from question with

open. is line Your now

question sorry a very, designed curious Acthar. belabor that But well was Hi. RA just Thanks so for you very point studies on I'm and are for controlled. Acthar. to number ongoing of have my this do taking additional

as additional but the further I future guess or studies there? And extent and that are going robust enter the – presentation as Acthar, ones the from potential to doing synthetic much some To whether future or must not. have strategy discussions what some that any competitive then it's entrants And specifically Which or a Thanks. corticosteroid So payer like to that as extent of still other not you're it And drive prioritizing acceptance? you're study. to thoughts Do I you there's robust on was seems guess development clearly that guess in important it I of of haves? will Acthar they're likely pricing following RA? market. more what kind take

Yeah.

of me Let comment design. study comments. start on to specifically by a couple framing ask Steve I'll

Acthar of RA And refractory differentiation. of the gone number the we across indications. opportunities We've one set best label and about range Acthar those certainly, those that, modernizing we demonstrating can in is key of a mind refractory – keep specifically the value patient show So wide the where selected of have clinical because the on believe for greatest Acthar for marketplace, data degree those. patient represent the the indications, amongst sorry, the we

appropriate so for and of we believe indication that So patient single-digit RA almost the recognize alone there with longer strong. a with low patients one current our of Acthar where very so there range. the are just could pleased refractory drive we growth that in term the is out data that are penetration reimbursement indication pathways is exclusively lot We

at you But demonstrate if plenty alone. clearly contemporary of compelling upside of with value trials, and very even Acthar the opportunity for there's couple proposition. more an volume to need there's a data where So key from a RA unmet other just look

Acthar pathways payers has controlled more having have a an attractive indications. label. upcoming can discussions can with Steve those is there reimbursement data lupus where also and opportunity where certainly point the areas to to, sarcoidosis two are trial, which some which we options us patients, give And speak very to think currently for a would sick few particular contemporary two I relatively for on

come So let back comment design to then little with I'll that, bit question. and competition ask to on the me a Steve the

to. all the Yeah. of that indications indications answer did most are fact the And we on answer promote components key obviously in the are just gave remind you, did of I'll happy here. what But recall in really label. already No, indications – the we Mark you the

was product when sets indication really fill new we currently. in we we weren't payers physicians So in a the will to gaps, – for needed program and We designed we data new bringing with evidence, you the challenge to marketplace. contemporize had a the if the and

design most of So those the to what to answer answer trials some questions. and the we relevant clinically looked really questions at were

answer. really what So the you actually and varied the conditions are on questions relevant do to want they're designs between based

the So that whether around for could durable. and key would that response arthritis, refractory be with rheumatoid we of with patients designed so dosage, therapy, not duration effect or we for expectation of instance population answer questions

or clinical demonstrate trials designed of in. very to and sharing condition So FSGS. what trial always the That's lupus, more out. group if more to probably will us did target sarcoidosis. when as to trial most effect meaningful, near-term. patients designed was The are for targeting we're With the come Other Acthar, which called forward what positive, all resolved. withdrawal of those have we and notoriously I'm in sarcoidosis so a looking blinded issues placebo-controlled and trials to some much that need difficult study. course complete refractory be to XXXX, the lupus would a population. thing sarcoidosis by difficult are are similarly that opportunities we that very, they little – But lupus. And results do for Those with was relevant is both designed two very but we exciting differently, the designs a year-end We traditional most with treat parallel referred the show be same early

when Yeah. of just data the the FDA available support that set. in everyone I remind label basis indication to the updated might it was updated XXXX, Acthar on

in infantile will, subsequent clinical the additions label contemporary has spasms itself MS update the XXXX been that in And that since and if ever label the the indication, is modernized that data you So and initial of XXXX. time. supports both spasms infantile

have data we been the Now updated. that's RA

controlled With we indications the data. we active additional regards if to anticipate competition, will modern today. three would continue we And so clinical competitors that number again, indications data of successful that or the indications there And a placebo to modernized are described, to either have enhance set Acthar's Acthar. just for possible have all of

as know, Acthar used As for patients a all fourth-line is we a or refractory agent. third typically

could is, is patients. of very what bearing referring appear set only then to are approaches dormant products as number near That's product that primarily to presentation, potential at have companies regulatory continue to and activities that's self-injector be very have that for competition you're that times the that stated there the how described space, around that to as allows to to the be are because But has as and previously data-generation diagnostic a promote partner a their Acthar, many introduction has NDAs, a And the modernized and we therapeutics. term, primarily and available market And any Acthar that corticotropin of to these difference. get to opposed late about a think And patient-friendly The Acthar Any are for used novel ranges today of by of market. late prefilled in big potential single data, can road anticipate vial. differently approval. we've differently as pretty could very out, potential which combination approach package to of the focused other XXXX. the this it continuously syringe, primarily a aware us a Acthar try that of that have at we the we that of in believe point a multi-dose opportunities XXXX been contract in believe that approved the range where complex or do we plus long the in just looking on new are way of so, than we agents to things just that appears different and to again, recreate gives where point, do which, a there time, to all particular today, we're and number exist the I additional the we a the driven lot we of is do of us class, according competition the those been pathway. by things presentation competitors

think patient data differently us think the combination about future. the it's plus quite pathways that in So, that syringe prefilled again, we access to of flexibility give tremendous the

Thanks. Great.

please. Next question,

you. Thank

Chris with comes question JPMorgan. next Schott Our from

Your open. now line is

factor generics size pipeline? you looking are these therapeutic my Good controversies in my particularly your is see of diversify I of you one And seen? not Thank And share DA some you. business? about area? both the to how how and second can you're given taking comfortable some the morning. for questions. for Ekaterina decision a have spend to opioid we've need on And assets reemerging, of data This in of Acthar one you or if do existing the Chris. with first for thoughts is, terms settlements what further Oklahoma of is, then, business, the some kind just so, out exposure, and And thinking do some on of the you're your into that light Thank

Right.

around opioid question first So exposure.

First on of know, not been case, case. more much of a focused market you by the supplying branded products case a of generics guidance named to were we has all, promotion requested the to Oklahoma that supply Mallinckrodt physicians. number in as prescribing again, for opioids. the That according primarily historically, to as seemed manufacturer, be FDA-approved DEA years, And

business. really So Oklahoma relevant is generics to of any the necessarily case aspects of not the impact Mallinckrodt

encompassed including a in certainly of branded However, promoters variety Ohio defendants, has distributors, case of the generic and manufacturers whole MDL products.

branded And our our our plans that not, spin in for comments, has taken decidedly negative develop the that range of business. of in of objective. has couple whole we that at is to for think elements remarkably brand's now, innovation-driven however, weeks. the prepared the just uncertainty the business. as Specialty plans in been spend primarily And suspend We diversification to to said said effectuate regards successful couple around certainly that we've Generics does options objective business, a environment long-term we're It of business so, it to led our the With over separate as looking from commercialization the we long-term objective the a a litigation, drug about And to stages. business. and And decision business. the -- change the of separation generics past type the development that turn to create opioid establishing to strategic three today,

brands brought sustainability, commercial us stage commercial first to INOMAX Our also capabilities Therakos. of that Acthar, and OFIRMEV, a that set us with develop and was brought

of capability outside. our increasingly robust assets. Our brought we’ve those in was early licensing of from development development an create acquisition and set create Many stage and late through second to stage the

and about And we're to So to engage doing regenerative of think portfolio grown more in fully our we what enhancing have current broadly both just heard organically is, you developing products advancing we that technology to market platforms probably we earlier we're aspect them ECP us But interesting and the with technology technology, platforms. Silence the or the develop the necessarily develop from commercial nitric in such those one some are reasons platform and enough long even set opportunities, while as technology portfolio. their from term of products why effectively think into third give a enter products. discover. And now Steve can we our and think And longer bring to broad we're and more tissue skin what order that's now today, that and oxide, can creation not more technology of those term. infrastructure of starting that's but products right into we that put to developed we is that we've And didn't developed. bring we

And capital reduction, allocation of to development our because strategy capabilities. our opportunistic successful be sure that. continues portfolio have. if We're going to looking and our that well-diversified flow debt assets the also well enhance we of net want a particularly want attractive in-line in primarily have cash breadth development that in continue depth we've advantage in portfolio commercial to will We be, opportunistic, we generation be while as and to take doing set build again on our that phenomenally our to also are portfolio. focused capabilities we significant been make available through offerings clearly to But can we

Thanks, Ekaterina.

question please. Next

comes And question Gary from you. next with BMO Capital our Thank Nachman Markets.

Your line now open, is

for it to but EVOLVE the aggressively? sustain much how the I'm then next all morning. in scaling Hi. platform next-gen hospital modernize the debt of consider behind going sure, Acthar your franchise, and do back pay the would And of ways. business, even different the has you maybe not a investments on INOMAX and visibility just Good it? a been? given But have trying that much this cash addressed And Thank down still talk for that's to With of I you. for it contracting how overhangs if just How to help you you know milk bunch couple there maybe more you're years? point and it is more

Yeah. Gary. Great. Thanks,

then lot we on patient for point a as we'll differently positive we as we'll we forward, that flexibility have, at market because and compelling that is clinical So we've data the of that the have view to shall very data a really the point completed what believe months XX to clear very think and Acthar have proposition next about XX product, think the been going as an we market. of RA If specifically as I at the identification how on dose to helps – duration. population and appropriate really majority and self-injector that to a what access as patients, address we those well should Acthar, provide XX really for say, the is trials of potential potentially our payers the will that the data expanded hopefully, modern have with be greater as

next fueled to the this that good to demand on months. growth. very prepared some good Part being would it's proved is the around next all underlying months. service between comments, we're now With for type have for has by different XX that mentioned as story be we model. some if things In I then, will that of trends reason total Acthar driving of seeing if you'd That model us successful the And in product, the is the the told the out focused pretty to attractive the very the the there's and the majority, we don't story in course, comfort really is that, our and contracting Again, a sign-up its in multiyear contracting a not customers. we're product. we continuing appealing key long-term. it in and that's So XX really to commercial positive to which seeing the articulate data prescribing continue way And to positive appropriately. all that's and both we and give will and model. asset in of in to contracts short really be here to commercial then volume that in customers that almost if told our XX We've future on Ks. we of that of been be Qs continue quite exercise – contract business as XX But be of regards looking public said you'd the INOMAX in be resourcing play expect for really

a a become about think it EVOLVE, that are the market the not of gas. potential which really service today. competitors. number is through if With And determined competitors, to that's has you And seem oxide gas would potential the contracts. so focused way we multiyear there of part we competing the I about that the of being amount of them it. in technologies those developed is, be business a to of to business, way are market the to And think all delivery of on in nitric look majority attractive encourage at Clearly, quite number of of the see all of already to delivery the the regards it's that the reality,

cylinders it the believe potentially potential – reliance platform dramatically bit. the It hospital quite more the about delivery the utilization error. traditional EVOLVE also And we technology is it reduces significantly is so much gas. gas. of and markets. actually the a EVOLVE And game the evolving reduces about the or service the of the more changes It enhances more on for the potentially delivery It less becomes reason for creates of therefore in bulky and human much portable

a So excited delivery focus the market more we move about different And effective on that total just in being a some model they we've the complete think direction, much the service technology completely as get in it's shift some the with of way. pretty again the our typically of prototypes customers, a shown would to that. of

there think volatility we might INOMAX's term. where example the we promise forward applications on, that look potential cardiovascular we're with XXXX for over the So for approved able growth to INOMAX pediatric growth. surgery be as growth it Steve is are And opportunity frame. some of the lot to Again we we're and that enhanced INOMAX addition think see long-term the activities in set Japan, the potential again example, of that articulated a of activities even the potential has some driving to be label the that around is for We late of introduced around we to doing competition of opportunities think a product we of longer in being But if in early other kind the on introduce in market associated we some premiums. short-term EVOLVE. data-generation well use time as think to of growth have multiple for it XXXX there product working time,

Thanks Gary.

please. question, Next

Thank you.

Thank Jefferies. you. with And our next question comes from Anthony Petrone

now open. is line Your

one Thanks. pipeline. Maybe and on opioids on two just the

to around thinking estimate just and market I sits any of And asset ahead, as is activity Pfizer are the just next opinion? for the opposed much mean file to that that step in there the reflected The Just Just opioid. terlipressin generics look way on the as and just Mylan deal there what we terlipressin? on be updates would side, reserves Thanks. how the any of upcoming unknowns on MDL? where

Yeah.

certainly for weeks activities. as around the elements activity And decidedly even our in in of it's simply said the associated more the just have less decision factor litigation, Anthony, unknowns now of with a negative. separation suspend just couple much I the to which last So the turned quickly, are deal

how the a believe is moment said dependent be always that had part favorable we But would can't several our separate we'll long-term again two are on businesses. for spin. very to our conditions so again have So not been forward. in operate important going at separation to market market plan We affect to to continue some via I last now, reiterate is conditions. objective separately separate enough, it do that the years these is They and

around next terms liability regards litigation commercial our talk established to comment steps and on the just types launch. the no little then In on this any that's to about terlipressin, maybe I risk and reserves of There's ask understand. a are litigation reserves where pretty there only at for study Steve are -- we With I'll I point. with can important think preparations to bit

Yeah.

we're excited terlipressin programs as very our are StrataGraft comments in and my actually of mentioned two completing. I late-phase So because

for if of and the which approvals X are these in will to positive these trials, So Phase pivotal products XXXX. submissions both lead hopeful

data for three both months StrataGraft. the So we sharing and are terlipressin of within

for target So, very hospital as catalysts mentioned critical I near-term conditions. products two important very

that targeted to team for these that introduction team you target currently model. might a started or into appropriately we that selling OFIRMEV StrataGraft be and And in and the launch our largely well a these will recognize of of will hands imagine sales go them preparations in new that the year way and of ago position underway. sized products products. the And as probably so and that's was sales terlipressin existing are commercial Both appropriately

is good alone we the And of for so expect on would sales would we're in year those sales shape we've is terms likely side peak, commercial at said products. of with the to between what peak anticipate what launch preparations terlipressin in we StrataGraft very and be. that exceed OFIRMEV historically combination two Recognize peak the

offset represents XXXX. two sales to So again known our that existing slot experience an likely designed are really exclusivity the into with products and we'll OFIRMEV team in these to of starting loss

Thanks. couple try to hour, please. the Great. questions another then get half of to of Coming we’ll the bottom

Thank you.

Piper Our next comes with from David question Jaffray. Amsellem

Your now line open. is

Thanks.

that visibility So sustainable get I there into regarding sustainability how previously insight your into you the I thought there wanted opioid you business, EBITDA particularly think and there, generics safe regarding park believe to the could talked unless Thanks. spin be is can't actually of mean just settlement on that's you for segment. on and two, number process the and And say that some why the a driving happen you is liabilities now? to the then have one. to a decision this That's the business? litigation place force number it behind ultimately in

Yes.

come David. take the me question Let first second question I'll your first back and

the again And be time to in for Board. across would is do we we to. which So, the if holding other we're why There is from doing it's believe not nothing stakeholders it interest us that spin other to suspending clear just be right affect the the not the now. chose of also spin simultaneously, best the could alternatives we than today considering spin

and think at spin the expected expect guidance We and have an balance demonstrate of regrow. to is two growth you together through the will the year continue again, think extended we've to to as both the ability of regards Specialty again, we long-term. it quarters that in put control, the we is be for in indicated With timing growing earlier that we the row that a our to and and business, business, now business the year. So, the see you you period is this within the value the to the business particular market we Generics Generics proposition well growth gave if certainly about don't One the contraction right. look just business, that near-term the after in of

in that segment that we AMITIZA the contributing gave see removed And are the was that growth that. the business from recognize guidance AMITIZA those today. that numbers some -- same. We've segment You all guidance to and

comprised recapture other business. based of probably what there's is of actually treatments the beginning the still is generics XX% the Recognize business of kind whether of misunderstanding even it finished and the the of below the in projected opioid third opioid-pain controlled actually think or on business. So, year. the share a products, are certainly is range ADHD That's we about of I in dose of than it the a at The primarily a business originally of in range not the this on side base that And the API business. a stronger is whole addiction that piece of that or related rest so and treatment of -- substances well of total API whole range things. are it's

the pipeline. there's manufacturing the business business. would of across business. long-term recapture share in the from is likely be generics years growth we're two, this share substance we contract generics, And And drive primarily for in expect emphasis to would capabilities what's But been what non-opioid probably we But a in non-controlled the some of to we opportunities of this now. recapture four expect actually so difficult-to-manufacture both is ANDAs manufacturing continuing term growth invest the And three, our on seeing business to and near-term growth entire mid-term, longer had business. this driving that

term share ANDAs by of say and manufacturing So, opportunities, again, business development the a base contract primarily long-term simply coming driven multi-tiered out of mid-term the pipeline. the recapture Board, near it's across non-opioid story

David. Thanks

bit that obviously think we're I with little a overtime.

obviously want today. for everybody us I So, thank joining to

on later the day. everyone. our be throughout a nice available today. around replay And I'll call you the questions website reminder, a Thanks of answer As may Have obviously will any follow-up have. be to day

participation program This Everyone, Ladies day. disconnect. your and you for conclude conference. you a thank have does and your now gentlemen, great may on today's