Mallinckrodt (MNKTQ) 26 Feb 192018 Q4 Earnings call transcript

Good day, ladies and gentlemen, and welcome to the Q4 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. [Operator Instructions].

As a reminder this conference is being recorded. to host like Dan today's now Speciale. would introduce for your conference, I

may You begin.

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

Joining O'Neill, George our Chief Trudeau, we will for me Steve joined portion Officer. are our by be Romano, Hugh the CEO; Q&A Scientific Commercial our Kegler, Dr. and also CFO. Chief And Officer; Mark

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

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

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

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

primarily for and the saw likely capitalization was find of as where part analysis. from our impairment share between our projections required goodwill a As market for the business price morning, future GAAP anticipated This disconnect release GAAP recorded impairment annual driven and fundamental in our this non we you our we today.

our undervalued. that it’s appropriate been GAAP. stock of was we’ve non-cash fourth stated, As quarter price believe the impairment given the length in determined under But we is levels, the at we these consistently time

morning, in moving the financial we of historical saw to pharmaceuticals Group XXXX. an Brands, Specialty Disposal also recast’s company the operates segments, to X-K Specialty continuing back Amitiza operation. this the in which likely two branded we half Specialty Generics prepared and Generics separate You innovative statements company now second from business; and discrete And intend the to

on and noted, We a we will and completed. until segment to these the updates Guidance time basis, assuming year company throughout both segments report operations year full as being a unless for the otherwise with total both basis of on businesses provide to is such of provided continue that guidance is will a continuing separation operations wanted.

to release company $X.XX this we’re the diluted Specialty morning. in adjusted are total range sure the metrics guiding X% share for of X%. per to growth earnings per XXXX Specialty comprehensive for guidance Our each we and Please all Generics segments to review a $X.XX guiding listing sales to be a to of and share Brands of earnings net is of

on few be filed Form that months. will within to this hard and Finally, I want the next are we remind at separation that everyone work for expect publicly XX the

let With this recast help earnings the information call statements financial which We models to start release the Mark. morning, businesses. as you turn that, and segment have over respective update in the included me to profitability for should you Mark?

Thanks, Dan.

the XXXX. we the the full highlights some to outline for quarter strategic fourth year XXXX. quarter very report Today, once from our overall and of strong priorities for We’re again cover pleased will and results the

in can portfolio and in for business We on million One, to for to After look outcomes pharmaceutical flow. contraction Amitiza two non-opioid assets pain, by becoming diversified Western $XXX that over by you We will company, the recapture strategy, manufacturing the performance cash to is XXXX milestones components plan our separating substantial months. introduction business generics, is focused StrataGraft. in severe the deliver The to ANDA quality opportunities. development completing substances Strong growth the balanced Approximately be disorders. APIs, of expected Long-term coming the data near-term is also XXXX, years and specialty last controlled Acthar expected Specialty in making Generics XXXX, vision. Amitiza provide Specialty API well R&D of for Generics and Specialty two, In inline dosage ADHD supplemented separation Mallinckrodt contract the key including as our we products. critical well product. the toward by forward anticipate and products to the several important growth as is like in take planned updates and additional driven between of Terlipressin like business to including combined innovation-driven high improving complex, the business; to in products, business key steps of with progress of development significant pipeline underserved return largest our driven beginning primarily of projected on share to oral this experiencing an growth for that on generate in conditions. accelerated and Generics EBITDA producer a addiction segment acetaminophen with range Specialty generation half will result the Generics of Therakos, and key key the the programs and patients

quarter Acthar brands performance and year, the products seen the growth our consistent in of fourth hospital business, with throughout strong was continuing in the the a trend to Turning trends recovery.

is demonstrated the in Both in portfolio. total billion platform growing the growth OFIRMEV in hospital Our and We XXXX. growth total the net anticipate single-digits to for high in full trends $X in sales. our hospital quarter, continue fastest portfolio and INOMAX largest double-digit now resulting year these

we feedback, significant expect at on clarity competition likely competition term, generic later competition Looking based on than XXXX. -- the in any process the believe will a XXXX year. don't from INOMAX, this rather of better branded potential Regardless basis. be will we in have on significant Longer we on further impact outcome, though, a appeal that customers

We’re very model XXXX. in confident next the long-term differentiated the in of launch service INOMAX, and the system of durability by highly our anticipated generation EVOLVE driven

in a studies of readouts despite number in including completion MS. RA company-sponsored multi-center anticipate general, with of ongoing payer specialty the Turning the we challenges Acthar in XXXX, drug's to indications, to and environment be we data Acthar, continue In several key affecting particular, in performance. products the in and Phase X pleased

We of to the dozen expect billion Acthar clinical more fueled years, to studies a the portion by complete studies in in these investment product more $X.X generated We than by the two believe to-date. data than half that next patients, should patients needs duration from address data payers dose regarding may who ongoing this appropriate provide and commitment key prescribers information therapy. and of to This indications. important for and the benefit refractory refractory demonstrates our

also continuing targeted develop are market in introduction XXXX. for We self-injector Acthar to the

to net years. over again believe Acthar to XXXX peer exceed look the as we few and forward in data billion the progresses the will product we year sales on readouts the pressures next expect $X and in continue, While

build Let XXXX. our momentum me you which with now on for the in four established share strategic priorities XXXX,

the continuing portfolio maximizing drive focus our of stabilizing on: inline further growth to value and hospital will First, our by Acthar. We diversified in business

Second, and inline key generating assets, products StrataGraft. pipeline for Terlipressin key datasets advanced and particularly,

as capital reduction plan the primary the a executing with net Specialty Generics debt disciplined completing Third, allocation separation. And fourth, focus.

months, we’ve already We’re good of in progress making the debt. nearly past repaid $XXX million these objectives. And on particular, few over

Our cash separation, a flow reduce total $X and goal of has free in to by the than branded expected separation been greater following billion combination debt the using business proceeds.

Steve? remains of recently the with key and we to to top Transimmune reduction a also update will some our research debt ask will of more lifecycle with to our perusing deal be our continue AG capital, now portfolio. While for collaboration on uses across development I such regards detailed provide other we’re announced Therakos. priority, Steve activities opportunistic as

that continue this progress continued XXXX. to that important we’ve number regard been many I’m to momentum stage activities to research quarter substantial the the Mark. report important Momentum early readouts data has and and of our pleased clinical clinical a trials Thanks, of build in positive development into we months X in advancement fourth with year, the months had and development across Phase and We milestones anticipate made trial the interactions. has of of ahead. FDA

results had study. consistent with activity recently of subpopulation have inline milestone with RA particularly to XX blinded brands, achieved forward results Acthar this persistently the enrolled that of supporting We to the primary trials. midpoint of a with low the the a XX% of add utility company-sponsored XXX% label our study's enrollment treat of analysis. open open results in high-level RA therapeutic study first patients completing to we the These more a endpoint patients. interim Those period disease X RA in were of potential Phase look Acthar label going at And challenging latest active evidence view weeks. provided phase the Let’s shown label the in that open discuss activities

regarding registry lastly Phase X, the Looking trials clinical of that products, patients expect enrollment ALS report proof-of-concept inline Acthar Phase acute lupus as recently our does to from Disease. at other Graft-versus-Host completed uveitis, planned, X study our announced we quarters. sarcoidosis, MS with And Phase as we pediatric coming X data December The studies each MS and continue and was in in data steroid refractory on in study.

four to XX% the this trial. to to were Following plan of enrollment rates after We later patients the in see to response weeks analysis we us allowed reached which our from plan data trial of interim publish therapy, year. stop this pleased

of enroll development me advanced for The programs. trial Terlipressin touch continues on pace pivotal greater in good a data X this one under expected and treatment complete will being of an is the are believe to Hepatorenal of Protocol Type the of in approvability year. X XXXX. late-phase are the at trial let positive, approval conducted Phase Syndrome submission and certainty most to us our as second Assessment, we this If FDA pipeline. program to Special our It's internal the half Now is important the drug. this remember, giving of

partial with thickness thickness treatment Phase XX% X is deep is Another StrataGraft, our therapy. trial expected progressing. burns Phase over study late-phase and burns year enrolled the program developmental for later for completion regenerative is also this The of skin full X

to We approval continue in FDA we the designation the XXXX. data the partial allowed RMAT thickness the supportive indication, expect If are awarded is engage under to for program. earlier will to submission this timing with evaluate deep which the

trial design the Protocol We’re with and pivotal meaningful our plan Assessment a recent work regarding Type discourse meeting very the to design other program this stannsoporfin trial towards agency year. population, the FDA issues and pleased A a submission had the to later refine We we on where of CRL. Special associated the with in outlined report registration

A We Similarly, intensive phototherapy population that for with recently we targeting the treatment discussed to severe advance IV new are Phase of Type program related the failing productive issues hyperbilirubinemia optimistic encephalopathy. are and more therapy ammonia risk formulation a we of of who MNK-XXXX, from patients infants suffering the higher hepatic may meeting a drug a for specifically completed acute our where intervention. X we scavenger

the hearing with to potential year. Patients expect of with the In compassionate use. through patient-focused FDA caregivers, for in and early study our VTS-XXX spring. of VTS-XXX plan efficacy and organizations submission drug late relation the with pivotal pivotal of to look a from X in the scheduled protocol And this portion we to drug label the patients start C, reach learnings as treatment we next meaning to we forward the development discussion a also Type design and an FDA, intended treated late be Niemann-Pick Here month. patients, as patient of continue development agreed Phase open

remain discussed As patient partners, our this area. group we’ve committed to in we deeply with our work

by available the adenomatous treatment been polyposis pivotal familial in results second. completed end be first and top-line trial for has we Turning to patients the of with the CPP-XX/sulindac, to early expect quarter or of made the

next designed ahead the with nicely for anticipated our EVOLVE, differentiated has provide patients is Lastly, been generation administration important of healthcare benefits practitioners. launch device in to INOMAX XXXX. to moving device and both This

the for is complete evaluated expand of nitric me perfusion ex-vivo to just proof-of-concept the as financials. will is therapy use of insights indications. the latter us expected it George? With beyond us to one to enhance several oxide options very to of take transplantations. our lung soon, potential viability this with may how lungs Additionally, that, current George marginal The being to study human providing who turn let

Steve. Thanks,

the the XXXX quarter non-GAAP an per After our diluted quarter, increase which $XX.XX, Turning fourth was for from earnings GAAP the share annual Dan non-cash loss of includes $X.XX, is year. impairment prior operations we earlier, to of adjusted a GAAP the assessment. share noted continuing sales as by reported adjusting the results. determined for over specified X.X% our were diluted items, $XXX million. Net per In

reported the sales, strong of $XX earnings in seasonal stabilization net segment with XXXX, signs with collectively sales facility Specialty quarter, per XX% net from of net net online. generated in and The generated $XX.XX In GAAP The in $X.XX hospital million sales, million sales with The segment expect Acthar in the XXXX due contributing sales generated started sales generated BioVectra segment up year of as we the OFIRMEV diluted we Amitiza to sales products XX% $XX to growth net net INOMAX saw Generics BioVectra sales royalties. to see and sales see $XXX significant adjusted $XX with per in in continuing grew new sales. net of a we we also oxycodone-related quarter portfolio net million quarter billion. million in increase full Therakos X% share million diluted operations $XXX $XX as to the growth quarter. the manufacturing business. patterns net net share $XXX million For the of and in Brands in of Japan generated in growth $XXX a bring in the see while of non-GAAP of acetaminophen in on $X.X million the million. Specialty and loss continued increased ordering

percentage Now, XX.X%, quarter. to some the as slightly from let on of back gross me decreased sales to Specialty metrics including Disposal Generics down of Total for primarily operations. company a to continuing net share details adjusted movement product the mix, XX.X%, profit Group the due operating

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

advancing prepare pipeline at will to expense and sustained compared project launches. sales future flat R&D in as XXXX, of strides year disciplined great net remain management compared make capabilities which reflects XX% generating SG&A for the on increased throughout focused in XXXX. and be to reducing was invest as XX.X% investments continue year percentage roughly We product We expense SG&A this and last cost expense as a in for to portfolio. our data inline we

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

for operating to of strong We cash cash $XXX was quarter million. the flow finished of cash with $XXX Turning $XXX flow free free very liquidity, flow the million year with million.

top the to reduction our Therakos, debt the we year Today, continue to make throughout executing back debt priority. after debt in Finally, significant total prior on our progress reduction. to down acquisition balance is will of debt paid the and XXXX fourth we made levels quarter including

goals, In historical between line get to intend net X norms our in we with addition times. to to our our debt debt leverage X.X reduction

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

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

Thank you.

Chen is question Louise from Our first from Cantor.

now line open. Your is

respect here question with Acthar. My is to

Just will curious will to drive think what this? sales growth you product and when return the

Louise. Yes. Thanks,

most we’ve the completion data all performance know excited future driven and What next of XX very for of and will has and Acthar we’re on be nice pleased Acthar quarters. the for this we growth the product about quite stabilizing the as you trajectory of XXXX, key point. by price. So we in be second the several as over the number The we’re which at seen two of the studies In we’re a future RA is looking and and be growth this the believe that reporting And is outcome past probably growth towards rates for long-term trials, growth datasets and of completing year. prospects largely by driven on XX particular, half again long-term well long-term we’re of that months. the at MS, Acthar are to And will not data in outcome volume going with over promising. trials prospects first key depending out of to or think

Thanks.

please. question Next

Thank you.

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

now line is Your open.

impact And this competitive comments, a Steve’s for part hospital for in of Graft-versus-Host One from bit INOMAX? -- US? business all Anything forward assumed guidance the you you little the for on entry plan What at I the just talk Therakos? go have about year. and the but can what’s missed for

then very So comment to and heard throughout on our a high from first let grew take single-digit it’s mid-single high plans for the growth continues large of us a be all the to been comments. the and me that, in range. business hospital business Steve single-digits to But I as little consistently business part first collectively our performing Therakos. of robust in bit will for XXXX you This prepared that ask

model US, durable particularly for that such Japan INOMAX described the minimal that an a is us our the may of some we believe because in product we’re of term, those competition any the impact in looking to believe for With total. the an to after in additional viability with growing in hospital lungs this XXXX continue significantly like is very at we what commentary for that be prepared is And of trends around business likely opportunity associated of to service highly technology where and cardiovascular customers outside at we INOMAX, regards And with of surgery. we're we from organs, all the differentiated about longer the course, for the that we in our product have use extensive particularly work excited transplantation. doing We that be is platform, as if specifically, expect the operate conversations markets term. us any indication XXXX. again, particularly product Longer for that a on

see INOMAX for So us. important product being again a we very as

good we if well, has been Now that about has product growth. think as also Therakos this for prospects a

performance the look with pleased to very again, single-digit it of if We’re the year, growth. in in the, mid performed high the you full Again, at of drug. range terms

and excited quite prospects for particular. might ECP the utilization therapy Therakos platform about its We’re use how the we in expand and of the

aGvHD we think of again for well just sets of that the the therapy. I development ECP that recently data discussion Transimmune just the the that relationship presented, we as in up as signed

you let comment to So and how described bit Transimmune with just think our the that are data partnership going forward. little ask regards what also Steve a me thoughts about the we to on

Yes. for I Thanks concerning and first been this to have community pleased are Mark able Yes, with very of to population. thanks all transplant pediatric the mean the partner we question.

data that these and changes product mechanism of the experts any are example Transimmune if of and some being well our included as like also have really populations we were we generate of for might It’s an the entered certain into in is pioneers we the of space which of into really I So folks value procedure we not work, of to valuable. in the opportunity mean of some the get we a who of really might product. that Therakos collaboration is we clinical enhance as a with us research to identify of where understanding scientifically investment ECP. to additional actually the well. do products the acquire, are perfect strategy better And the device action with as the preclinical doing long-term work believe of able in lead a able sort tremendously population, to do ECP example Transimmune the

So we’re very excited about both.

steps Disease looking what and the that acute at the our data, in will be future. near next looking and will We’re study very Graft-versus-Host we from at deciding be specifically carefully

Dave. Thanks, Great.

please. question Next

you. Thank

is question Dewey from Canaccord. Steadman next Our from

is open. Your now line

on the the and on or of patients physicians RA the combination interaction been or of full payers with that any it’s with X And of guess payers program? Phase it Acthar who sort of or I read interim audience is the them? it has prescribers study, a just for recent then announcement the or is enrollment, is all there

Thanks, Dewey.

in So Phase address our that the Acthar X patients to data the generation opportunities exception ALS pre-fundamental appropriate with Steve on refractory define on-label That’s on-label in there we’re trial is identify are data really patients. fundamentally is One the to mostly the designed proof-of-concept key, program indications, clearly of more indication to questions being generated market. But looking referred to. Acthar we help benefit patients. prescribers refractory for and for to payers is those patients of and utility which where most for potential incremental specific typically at appropriate highly believe or

two of to dose duration. other address areas The and concepts key are

significant health we patients, generated specifically at is on help top If define the and the probably most to specific our to less studies of these duration. that believe on-label prescribers indications. particularly around on been and be dosing information will package today, refractory you dose and key meaningful think product, duration data appropriate amount important full and that's dose economics. to appropriate this it’s patients, and payers addressing think again, and both further it's of we going look that set for label the And are but for We indications, these duration

Thanks, Dewey. Great.

Next question please.

Thank you.

Samimy Stifel. Our is from question from next Annabel

Your line is now open.

have have that some year, are opportunity the in be actually to readout interesting datasets this some filing on you of So and those. guys you

us you out one, of that you forward data with to expand study of number that be whether at least at we Thanks. specific for after sort Steve, know be first, going Disease, I an sort give acute opportunity going pathway the you And that, can for? the Graft-versus-Host can are you is and any population? but in that back, file to are can the will you booking us there extension going right So looking just going endpoints idea, whether

Yes.

maybe two Steve take could those So questions. you

Yes.

that to So outcome study know and you number are associated that is the a event as with really progression that of in is of events CPP-XX/sulindac with a time disease.

whether intervention at attenuate really surgical of we’re treated through looking what typically course largely. can So we condition. condition is the That the is

is that a just and actually away we’re result. complete the few weeks study So top-line from having

So data I use hope with you With are utility Graft-versus-Host, that of to next very, and we’re medical and at consider our and with as supportive again, very to excited data ECP the those mentioned, are experts the share steps move now talk of data, regards might that we’re field really with of we soon. I looking going acute we to that forward. the how the

will this later be presenting hopefully looking research year. at certainly forward to that We meetings

we we’re that. opportunity long-term opportunity to as in really think is the a here ECP particular Transimmune how Therakos combination, really it’s and the data just progress generated platform growth partnership the that to think and in evaluating I plus the enables us best about

Thanks, Annabel.

please. Next question

you. Thank

Our next Wilbur Elliot from question is James. from Raymond

Your line open. now is

the not paid you issues any And couple confirm doesn’t write-off potential just the your Thanks. commentary was these through debt I in of quarter balance two-thirds XX terms I a seen Questcor’s specifically And or during the guidance, the Obviously probably also interest questions, of of we’ve knowing months, and to that? with expense specifics charges? look reduction reductions of elimination Just goodwill sort to part. walk know over further probably post the want think interest quarter, did impairment could also, expense that and the attention like over us what time of entire some to to course half next Therakos led embeds guidance balance significant what balance but obviously of of your just a I what periodic additional respect down change? the were one-time financial actually complete deserves but

Elliot. Yes. Thanks,

that described. start then on a framing that the some you bit to in to little of little me going comment bit specifics ask Dan a Let I’m and

use So primary think we morning just of significant objective we including of And allocation I capital tune is with the and repayment this in in since capital. very last XXXX $XXX million use describe of on paying very of back debt we’ve track of first spoke to reported debt capital strong in think primary have what to regards strategy, all our since amount really debt our we that to record you. repayment a I clear early to -- been

As said $X billion we of anticipate debt of a XXXX, going repay we’ve anticipate reduction total we our fact the that for to we be also capital that primary described use also to is that and or branded that might conveyed which flow the be the of cash business greater Specialty debt operating to to business. separation, the separation pay the after raise and would proceeds be using down of result Generics any on we

in specific to questions objective XXXX. of So again, for just want may address Dan the XXXX Elliott had on it was the a that you debt in like primary is again reduction us model? some

of quickly over ultimately time certainly as can factored opportunities may that. aggressively us how debts With Elliot. I also about there for but Sure. think, we debt this have Absolutely. level and down we how in provide questions. interest think Appreciate the be respect Thanks, expense, to we to in update reduction to pay some

what In addition got throughout point marketplace to happen year some that, as would this you you the get when rates interest in the those things couple interest to well. that considering we’ve think debt rates and about obviously variable happening a at are

about that specific we updates goodwill price those I and stock With as as you for you color to and market we to consistently where write-off, to of future balances one is cash there's we’ve optimistic more give in think do things reduction you relation are, view normal that, our look, on processes in make we is our respect very on where as we that and is business one look about and the on to under a that as our goals have we process obviously our this where to debt continue the the annual disconnect provide GAAP question look go. to that's look. is part addition So a a where basis. of future of do have performance -- When that that is but bit want found required came evaluating also that key across valuation give you resides to your between progress that where balance today. and our of goodwill flows something I interest at going have on expense And future we of are the is that where to will valuation at and our to an us, the intangible

is so, really under And annual think the doesn't that the today future a really processes write-off of can in realization that do period been what a our time the business minds a over change write-off price our necessitated at time. level and has it kind for as of stock we long-term the to

is the I share look of write-off. difference we very been history strong. is we performance it's accounts at which think future And and if between It non-cash price expected the today. think it’s basically it’s disconnect our our actually you performance a operating that and believe very and strong business quite simple, for the the what of

completed we was goodwill. in XXXX the appropriate as process to the so address And annual it

Thanks.

please. question Next

you. Thank

is question Maris Wells next Our from from David Fargo.

Your line now open. is

lower the in I Is item. five model think old combined I three longer the and it say say do you it. experience from of in Sucampo up so, there your with if miss-reading you now, Canada increase when years given add Mark, accounts out INOMAX, receivable? just US spiked Because number And up business in describe in years swing And like we that one then my year, now they how so the the you and a get accounts the or term take few than a key might to is factors be in when Can where I spiked follow-up you but the now numbers? that lower and fourth a seems receivable, are quarter? anything housekeeping what of because consensus it in where be seems kind or Canada than happened competition? saw price to higher are

David. Thanks, Yes.

is may think comment around referred to that that the which can And be George how receivable on to. INOMAX accounts question first the take me David about and particularly Let relative balance you then Canada. we

our us potentially very we’ve again, basis, to in surgery us, very than we long-term as product we on that INOMAX customers. pricing is it's process aspect things future very nothing business, the Canada for now we’ve highly US rather perfusion regard Canadian US as the benefits to about in what the know it, see patients think here or good good really able a continue for feel of on feedback we based all of branded to opportunity probably couple for well are is our in second pricing price. and the at of of of encouraged it, utilization after which you a share an as excited and a that significantly an asset opportunity very based Canada it Canada could a promising cardiovascular a indication to is that’s the blinded have oxide Again keep market we've the competition Again there So be in share why basis. with because we model we’re And to is differs with the on the not to heard that and pleased our for our overwhelming is where the loss fact side way quite We here a model exclusivity of explore believe nitric likely or and the like reduced from been from the in and long-term. we’re merits think years competing model. if on works competition somewhat long-term bid lung experience platform, in in it generic model that mind probably Japan. seen like technology this to retain about the is the in on share that growth differentiated again the we’re you and defend broader model, significantly you pricing George, very to keep durable the good of for address hospital-by-hospital on of simply is an that based maybe question. we're the that INOMAX look specifically albeit opportunities And business, able study, ability account-by-account to while market by your

Sure.

So, there customers a also very that in of one business. of issue the XXXX. timing due through accounts They key drove processing receivables. going of year the jump at year, up was Specialty receivable some the to the end within customers our then of a to buying their was with early accounts the did wholesaler late Generics resolved primarily in sales of about also had which finally one from switch direct And

there. So saw some timing we just impact

out ordinary. nothing So of the

Yes.

question Next please.

Thank you.

question Our Morgan David from next Risinger Stanley. is from

open. is line now Your

is for your the few Acthar Risinger. readouts an on what Could with regarding watch dialogue FDA provide update David are the interest This in placebo-controlled characterizing Shen Acthar? FDA’s key Zhu years? please the And the Hi. also over here to next trial you

to might Yes, a cover. Steve be question that you good for

as mid-year Rheumatoid Yes, trial me that heard you clinical is if that as will. trials, along refer one will to. the the readout you so far Arthritis furthest as That’s we have the

complete that the the second of second will half will of in year, half in out report the the So year. we

that We this registry other was the are trial referred MS and Mark year the that to. completing

data the So in the that those of mid-year are on year. half get by you early second going the are two or to

actually lupus, lupus enrollment for Now there for to another this as well. several later get and the study completing that very of is one are And there those are or studies excuse uveitis -- include close another in ongoing, they year. four will me five MS

trials will you to Mark as completion have trials those will of over doesn’t said all those results readout. that the mean but XX next of XX enrollment months Now

[parotitis] starting year. are We also trial actually later another this in

So some it's of which next and trials, will months. year, readout some XX set of this full year in will to complete XX readout a of this enrollment the the majority will which

The other was question to? referring

characterization. The

A, submission are looking our we those results. awaiting label a and so have for to agency update yes, characterization, The to made the

those hear We about will very soon we hope.

Great. Thank you.

Next question please.

Thank you.

from Our next Capital Patrick Markets. Berenberg Trucchio is question from

is line open. Your now

the reductions than imply this. included on DEA has more in range offset XX% will the you that opioids So seems guidance your and XXXX, dose quarter solid to in

accurate? quarter gaining by First, share, are it price if is you increasing the And offsetting it is, or decline both?

believe in Yes, back XXXX growth is referring business Patrick our comments, to likely return we that general the after again to so contraction. just in of Specialty experiencing period to Generics prepared an extended

by really drive volume that or what’s environment be do this we XXXX. to business. going fundamentally in We recapture to share is negative But growth business’ relatively pricing basic Specialty to and base return think So the pleased actually are and continue the that. we to expect the Generics

then for manufacturing. products that, quite for will launch addition In to years pipeline ANDA of business has in to primarily we've business, a and there time. development long-term are think some had in file And we which investing in they potentially the start opportunities some the for mature, as that been near-term primarily contract that number several non-opioid opportunity this to

Thanks.

Next question please.

you. Thanks

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

is now line Your open.

XXXX? how your year that in A And year? still follow-ups, contracts trended year? pricing next resolution Acthar. And on litigation And of appeal mid this quarter? then the by are you over trending you How visibility first expecting this on couple see INOMAX, that what's last with with do and then, has of the

the to on the take follow discussion. Acthar INOMAX maybe ask and Steve question So up I'll then I'll

question, the appreciate for it. Thanks I

seen direct really identification appropriate the has the be before, with then was where a positive the and the patients this modernization we’ve be growth, visibility volume when of product to be really actually proceeds driven we XX-K. throughout file Pricing volume that potentially documenting So by to on going product continue on dosing how marginally our of that to which it highlighted what readouts and and see and statements, we and the been data strategy to duration. negative the those case future in year. will be our regards result is INOMAX is again the by And specifically is of depending product going and have we some it The future or driven product might our been that to will nominally expected of you’ve and seen of positive public the contracting the in we of you growth. be

competitor actually discussion they any for pleased our contracts may potential contracts with of business We’re And very above that out that’s again, there. that renewing the we're -- at long-term had have or historical had with levels. many seeing they that's what in with customers after with

we significant months highly which the being And customers. space. how trend we offering have to much likely I the can't in there competition This that may oxide in existing our that potentially around advancement of may significant appealing we this IP the future second XXXX. anticipate of the the introduce development very be we of only rapidly again, which based is and that the feel on platform but that EVOLVE regardless come we the the is INOMAX to is half continuing market able in enough our continue again, So application we something hear the differentiated advancement very strongly that model and nitric we to could several any in platform emphasize in the outcome that service process think a towards will year. the value be sometime next is of from appeal think not importantly, again, the And to anticipate its it That platform. --

thanks. Great,

Next question please.

Thank you.

from next is Our from question Amsellem Jaffray. Piper David

Your line is now open.

Just couple ones. of a quick

but to maybe Acthar, with the XXXX the on on have their ACTH tough answer, So diagnostic filing product synthetic a indication. on question Assertio in just question you a

a secondly best impact long-term, does then to non-substitutable the entrant? you any do And Acthar that where and over maybe you ask from the So trend if way on that is Terlipressin. envision meaningful have product

OFIRMEV is way contribution good as thinking replacing about a thinking about loss of way flows significant Thanks. due good of exclusivity, that the of its to it cash a as a to from about lost a think contribution what’s terms of In dynamic? chunk of

Yes.

questions for those David. thanks So

competition, primarily in we variety additional expect indications. highly labeled to remember, the development OFIRMEV we from this potentially other to based those be be lot launches half we're additional see question to patient of for that addressing positive, we of believe we are And and MS And it’s the for Longer that’s in long what in and we we data. its with preliminary potential next regards competition going Acthar around long any of payers have got loss to categories offset positioned be whether the all term, that’s they drug. pipeline match for not data First offsetting long-term may significant it population. two Steve sources significant highly hospital and to certainly the directed competition the positioning well. the a data other has then these if in and trials again, a XXXX we is specific product then actually or and generation the recognize discussion in data looking prescribers of products exclusivity going the mind results come for population corticotropins be for development both the of highly there long-term to we in is is across fact RA more from at the that's drivers come if versus is over much we competition the of of products StrataGraft XXXX, And may related than potential a completing that again late opportunity over all of will months pleased the mean OFIRMEV. that have to going duration going would I any right business and second dataset In competition, think the Acthar again customers is least that more products XX when we to losses as story both that that’s of that likewise those directly with Acthar which have growth portfolio with We over our as run. refractory We growth the to to towards assuming two is as than data of again think near at in But that we exactly Terlipressin where the positive. prospects clearly due Acthar two in think XX regards and and we're and exclusivity way. really Acthar's term, really we today out any generating and really believe our and refractory seen, more prescribers Acthar on is patients we a time it, in of we've very year. generating are described of some about that that the had LOE from positive products is run, the the OFIRMEV a both and and are up refractory see positive number believe would that over example, with the combination any those played But keep drive other that payers. dose have what's a that stage of these of assets and would MNK-XXXX And with might Terlipressin, the for like prospects

Great. Thanks, David.

please. question Next

Thank you.

Our Leerink. Fadia Ami next is from SVB from question

Your now line open. is

I have got three follow ups.

sort of how growth talk that, the can also could studied on what Secondly you about competitor device studies endpoint, potential mimicking earlier like and other top other hit indications? endpoints studies protect points your you you And you just layering model? on approval? seek different of And from your then from an change of of potential sort maybe about on to if indications that any that the volume you then thirdly if your there volume? Firstly data contracting growth differentiation potential CPP-XX, see you where and Acthar, go talk INOMAX, your some prevents existing get and about talk And to is from were then potential don’t help ALS? can may FDA on

comment a take on little ask on EVOLVE to questions the Several ask INOMAX to Ami. INOMAX, and and then Hugh device start I'll Steve Thanks, Okay. comment the CPP. here, and the going bit I'm the Acthar on question to

trials of driven again And growth we not data so. it. about least talk next is those say -- long-term when be direction, XXXX to assuming present we two studies again driven some by would likely likely again very the be to be about any reads that new years to at that are those typically by the think data. positive, long-term can growth clear for with or will we to think data volume two And that and way the price. volume Hugh generating. in for readouts volume we prospects anticipating clearly, follows. preliminary to historically start appear have expect be and we expect seen to volume we What if again the correspond of Acthar, So we is And growth the growth And was the the that continue that's on on again, are in I Acthar, and be growth trending going Acthar data to first

full is reward course trial. proof-of-concept little sign good on would that expect in high a from this our customers, the a Of ALS relatively our may for again thing base and comment opportunity. that competition that be an from marketplace. are the have can with of we're nothing Acthar a it were to customers options. flexible our many it’s relatively in we you transparency service on reflected pleased specifically the it’s differentiator to may continuing have for copying while model One but patients It's for there's customers, Hugh, ALS our patients data the customers INOMAX, customers the that the highly in very like opportunity to also fact if about of model. our there Based really you the long-term that. relatively developed. hearing news large seem high needs long-term. us These what up customers of With that prevents we to future we've risk that positive, And device. see have be competitors completely contracts few growth despite is on many regards in augment to EVOLVE of the and that maybe model And

Sure. Thanks, Mark.

the now DSRX the this as improve we’re also EVOLVE about our state-of-the-art interesting INOMAX the but hospital The hospitals very is excited but hospital. which directly how delivery is about at So thanks INOMAX our of the for delivery is in the only efficiency of to because this know driven the another is brings into into quite the feedback really with question. and it to level of INOMAX developed of you through the which the from was customers expedite device not that delivery

nitric potentially changer we it’s game So very feel in how is oxide the into that our confident delivered customers. target

has three significant a it there’s not unit only the advantage significant platforms. And future very existing One, our but portability about are is platform things that of the attractive. to --

really Secondly, cylinder reduces the size. it

side calibration becomes human with third effectively application. it other it potential bedside that to And CPP it of it the it. user-friendly the can of system, which is So like fairly We the significantly reducing error. elements a to little human on of to you of a can Steve maybe the an piece bit type more and much is almost complex. make the with opportunity comment reduce error has regards

of to briefly trial And I X purposes is results filing. trial as close Phase for the Yes. of X a very we’re Phase mentioned very getting trial the pivotal that

its case consider the alternative an So that in approval fact in not it’s for pathways premature to if meet did endpoint.

So when or endpoints. meet agreements those with implicit program, the bottom-line your you is otherwise agency, you the make need about to

bit the I talking for other us agency you’ve a the with VTS-XXX regards has seen CPP-XX/sulindac allowed rare or early more too with to flexibility orphan comment. instance, analysis when flexibility, about to always just it’s our of is we are flexibility approach bit some think conditions there and to Now for a datasets but

thanks. Great,

question please. Next

Thank you.

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

I the in updated second your half, business was in opioid to get we separation Oklahoma lieu trials, coming thoughts October. Cleveland curious Amitiza to with in generic May just the of, and Just anticipated two think the in have

the churn the business. might ability that from So execute any all secondly, the you then your ongoing? and remove just these to brand trials investor to if more around spin when any Point how And concerns how are cash mitigate being impact liabilities one generative separation?

Yes.

of on this. a things couple So,

is First off two last thinking let's understand and probably, diverse to for the of the a Mallinckrodt be EBITDA and we strong very certainly this thing this any years. non-opioid and separating to well-positioned make risks nature. have we is really companies robust the we that in within that And that time, with been and very well to other businesses the excited business going spun certainly have these name, couple quite some And are all that would for with inherent quite primarily intend business. about it’s opportunities cash pipeline this business flow of and while capitalized navigate the about

think a there we is get of these the strong at So separation going very are opioid the heading. on to more Certainly, look rationale trials where business. are to clarity compelling we and

as in of One and of there that couple state going the is things plaintiff's already we been dismissed a outright, the encouraged about claims have are been that where the Delaware very have that cases Connecticut more robust. we very little these continues the think and to separate information a course businesses again opportunity get to to well. MDL be on the bit Oklahoma of case But

want happen, marketplace does and and there may business. combined the generics to segmentation the the a anticipate and like in separation we would may investors turnover However, certain branded we that time. to monitor will own separate investors the appropriate own the at continue any business other businesses separation be because When the Amitiza want and a investors to will

with businesses in that So different has two been what when are separate. directions be strategic heading dramatically practices that usually would consistent market

Great, thanks.

question Next please.

Thank you.

question next Schott Chris Our JP is from Morgan. from

Your line is open.

here. Just two questions

balance were are are an as the a to business the you there should come still longer-term structures better initiatives $XXX for down talking where R&D about 'XX margins making? two was with of opportunity brand kind the that for these can guess generic I million I I please a and SG&A we just And over to ex-Amitiza, think time? you handle margin on in the second we relative in we the separation? the then you we you think have for color branded think bit investments specifically further prepare question past as a are get in target. about as trying specialty my cost you on to of more segments that shed First, some and businesses

Chris. Thanks,

we on we are Let I'll XXXX heading margin a me ask to on then address in looking little Dan and structures, to SG&A bit comment where see basis. where that go the

Mark we And EBITDA the from of obviously plus that Specialty next the perspective I highlight we think I Generics this EBITDA one Amitiza are in move earlier year. an indicated want expecting business things that range would into is of obviously $XXX that important as the and million be in

profitability. trying the things that constantly is provide segment of One we do to to are today

aligned RemainCo is business, each We have with our one with businesses, generics obviously the intended the which and respective the Amitiza. separation segments with one branded the the and business of

to give the you you thought ultimately at initial As operating look that reporting, kind business a at profitability segment going that’s of will that what be.

Happy something you that’s to details we take that to go to public. just related kind until account becomes you obviously give that percentage provide you SG&A R&D provided of that’s look sales, into with Form of reserve much how reflective changed as obviously I to the our that take Form greater EBITDA If through the a information those you number a about go back of operating kind like, you to providing profit, be overall of want XX back ultimately the when as that would think going that today. offline operating should gross XX and margins percentage we over you business When into -- disclosure profitability aligns time number think certainly to over and but you a to at spin-off specifically need sales, the we maybe there and have through. able

opportunity launches is on this sales year primarily move portion SG&A relatively concerned, flat cost We XXXX. strides expect last as in prepare see right in year as of made as working cost I as to and reduce we’re now the costs far lot we throughout indicated we we we ample product a to XXXX tremendous As of our later reduction and percentage year of that structure. remain still throughout think and readouts the for things into that’s we got as we’ve because data a

for product those So right company launches. of lot a the ready to there effort now is

still from you may opportunity see in saw as is ahead you And so XXXX. as there tremendous I us progress think of us but much not XXXX

And look here, effective I Yes. operating it just put just driving acquisitions as Dan that in historically business’ XXXX. the target, efficient business a to in you XXXX. at then whether frame million said demonstrated business. the in branded everyone we quite remind efficiencies The is think $XXX SG&A just to if we’ve post in level And it's been again very or our versus

of against over already a years, that Dan progress also next we launches. couple have we’re anticipating but to great mentioned that as number So we’re made the in of product likely XXXX

But new why gave what go maybe and bumpy be SG&A a XXXXs, our from period as early thing we of pipeline. next over actually good the products getting new a that’s lumpy couple to be through again that of products introduce as little So expect of good to the bit we out being out our launch we’re as a million years would to that opportunity in ready this we pipeline. $XXX

of coming couple top do on to We’re the get more through the a questions. to We want hour. try up

question Next please.

you. Thank

question is Sachs. Dana Goldman next Our from Flanders from

is now line open. Your

could two on just what self-injector in mean the I some expand have play on margins about in franchise over margins conversion medium-term? talk first compression for you. that Thank bring And specifically, ones. My could business generics my growth the product expect look in talk XXXX, just for and gross what that should the you you and what benefits the a just gross and that about guess outlook given of price? quick I is we on and launches and API does we follow-up mean is Acthar introducing mean just the ‘XX just the help I quick then business CMO in for the should or then that kind that as

Yes, if so talk the question, will Dan, self-injector. that’s I sorry, question the and just margin Acthar Dan Acthar maybe maybe margin could take about self you I the -- will take a

about going going think you in as range segment speak XXXX, think basis at a think look be I we of in a not to a you point and in Yes. when similar percent When saw profit you’re at XXXX. gross on to did what to but be I’m probably as you what sales this I

And would where part general for data is enables for multi-dose think way us what concludes with Acthar patients also that strategy we believe regards pretty play are of price delivered. today This or into our could a having we’re quite indications the It is overall which style in this ways many delivery any in in self-injector the device the we’ve infantile spoken for to comes delivered indication Acthar multi-dose the is opportunity. that and a really Acthar more advancement of. significant or specifically market. This patient-friendly that is spasms excited modernization in adventitious about style, be we generation But rate other Acthar in to one patient-friendly future. think is and we the a creatively is Acthar, quite modern indications package about based. the

we device a some flexibility clarity to again attractive lot that And just tremendous on in data to essentially have of example. So payers patients, market. having delivery think much could advantage providing the particularly rheumatology seen a prescribers we needs of when dose more areas for a patients, and address have the tremendous in us growth of like gives unit and duration, be on dose gives additional available where we it the a

Okay.

question, in those We still are I one to do going who apologize more queue. are to

you. Thank

from Koffler Mizuho. is from Our question Irina next

Your line now open. is

get little I for combined cash the the on a wanted flow granular free to more business.

the in XXX around was quarter. it So million

generics good piece this in for Amitiza lose business, like a to could years? the cash what in are on more of run is get if if versus detailed little bit wondering into you the the it a looks next Just we going Specialty going rate flow free And forward which couple a year? Generics

Thanks, Irina. Yes.

going to on think Geroge ask specifically comment flow. I'm we how cash So to about

a a is to on very I Yes, estimate XXX reasonable go use the forward. million think

but forward more good to We a in than are basis. on looking go estimate slightly a XXXX, it's be that

typically keep thing first obviously quarter in the the year one quarters mind throughout Maybe year. the is wider I flow mean is and the a as of seasonally Acthar to quarter

account So XXXX. higher the the indicated is it free thinking think our you you cash But flow throughout year I I belief about in intention run the decent next George think take or you is than need that rates year. be are find what as to when make sure will we into that

in going separate Mallinckrodt very would we each to And the those businesses look even flow. change these being in except robust way to described if We that of generator really been consistently you gentlemen historically robust see a again don't business any And of be more XXXX. as has two have total forward anticipate flow. robust to we probably in businesses able the cash generate cash

that’s Q&A. Great, up our wrap and going to

I to So thank call want the everyone this joining morning. for

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

thanks great a day. So Have everyone.

Ladies and gentlemen, concludes in your the This today's thank you participation conference. for program.

now may disconnect. You