Mallinckrodt (MNKTQ) 5 Nov 192019 Q3 Earnings call transcript

Ladies and gentlemen, thank you for standing by, and welcome to the Mallinckrodt Third Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today’s conference is being recorded. [Operator Instructions] I would now like to hand the conference over to your speaker today, Mr. Speciale. Daniel you. Thank sir. ahead, Please go

Thank you, call. welcome today’s everyone, Good morning, and to Skylar.

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

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

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

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

to to As recast noted and $X.XX we perspective, Mark? $X.XX. low Mark. the XXXX our release, be in share the per on are net all With otherwise full diluted end currency be call of me our now turn expect Thus, EPS are From a we to the XXXX we’ll earnings range to that, growth discussing adjusted guidance over diluted year let adjusted comparable $X.XX. sales ranges period, raising to are constant our quarterly comparisons guidance specified, basis. press the unless a

latest positive highlights address. provide an business uncertainties and we will followed update in take the start off highlights. advancements to Thanks, Dan. And the in morning our good quarter pipeline with financial trends who by will R&D through with continue Bryan some you that you on third business Steve I’ll including everyone.

solid business of up consecutive EPS with financial had for for strength capability to third raising some guidance quarter and in Q&A. financial open continued another year. our be pleased resulting We our we this flow the we’ll it quarter the Finally, cash and

In the business effectively. driving and on the remain addition, transformation efficiently operating and we focused of

quarterly I touch Before where efforts maturities. business to into matter the pending want the are and the by opioid CMS term near results to and and highlights, we based the litigation, the I address on uncertainties of driven resolution get our ongoing our debt

months. is to issues on goal coming the in Our reach these clarity

on Ohio. during First with opioid settlement initial cases we a to respect in litigation, reached the the quarter,

in are continued resolution framework we Bryan in morning, can later and optimistic remain the our private developed will balance to our our for discussions comment this matters call. debt unsecured focused notes, months. be sheet, reduction. a we we strengthening Earlier our net We regards a active exchange that for to With global offer coming to launched be a these which on

took short, which on working a Finally, out laid We remove we’ll pivotal advancing forward and strategic successful front, our with top data we in success terlipressin a four the pipeline from a Generics pipeline, inline portfolio, year, at our capital address the Specialty our maximizing an discipline four, impacting potential of In be step the been time. to that We StrataGraft. these of for and to as at any We’ve impact wait are one, the completing across generation focused recent on delivering business. encouraged in the associated to two, line uncertainty matters the We pillars attempt address in and beginning see remain associated focus. our the of strategies executing debt with net continue the and diversified X CMS value remains any to the could advancements primary Phase ruling developed by Developing range three, readouts and we the come portfolio. aggressively priority. diligently ruling. of separation, the significant allocation reduction

We which distinct maximize is way We continued operated our quarters. and in the independently businesses by continue value generics last of are that that separation the return to efforts ultimately best the separate Generics and optimistic of three show to evidenced clues brands as both. our to to these remain the businesses and to believe has growth

and trends, duration in of including RA, for Acthar including for in our Acthar portfolio Gel RA INOmax. we’re communicated growing prescriptions new inline continued these certain well in longer Despite encouraged be demand volume our payers as both Based on will a be of this ranges data demand following certain apparent promising to performance presented trend areas the portfolio, emerging what earlier prescriptions previously the total certain brands Turning our by we to year to full appears in hospital this Phase as as the potentially indications. for the X trends reimbursement therapeutic patient pressures challenge Acthar year. key approach compelling face within believe continues care

that ongoing stabilize landscape the improve should Acthar to reimbursement believe strategy potentially continue for modernization the Gel. and We to allow us

Phase payers identification We’re RA the clear interactions our Acthar ensure Gel product. of of beginning appropriate is the payers. patient, focus budget play essence the potentially treatment, and and with of recent to out approach a for to of see with data duration commercial payers of this the certainty the The dose since X availability in for

providers pathway concerns for of additional and approach the payer the indications product of subscription impact eliminating while for a Our in allow payers the greatest uncertainty. the INOmax. what reimbursement annual budget budget similar to labeled to an model one to is for patients for exists clear could limit healthcare This

the currently preliminary in We’re this of stage strategy.

extremely X could coming patients, information believe the readout successful treat including use dosage the debilitating label and disease. company that if to Although expected Acthar in unfortunately appropriate Phase duration. patients Patients patients further product we have includes serve. and currently important the this an trial options suffering Gel Acthar in lupus very from that months, remains provide the for for we the lupus few

we the year and in next or the device. towards will while next so the presentation lupus, a of clinical sarcoidosis working uveitis determined like expected be of We as await programs generation story with the self-injector Acthar further in data product Gel

that’s in see high model. total by continue we agreements the strong for INOmax, measured nitric continue from Care at oxide for amount an at in care all-time customers. in Looking INOmax Total of of INOmax’s as to volume patients the We're multi-year the value to growth demand offerings delivered as to see the customers business coming by our

high we translate to directly came net did this saw more not from sales. Although consumption utilization rate use multi-year unlimited higher tracks, that

We will expect product rates. quarter, back return normalize to which in this fourth to growth the we historical believe the

care in an experience the our positive as customer usage device important in continued as to well total history has INOmax. fragile that change the model investment expect under of We well continue execute based to and most a differentiator leads providing development excellent life saving NICU confidence expansion. the INOmax don’t product. the as EVOLVE on on the patients We as for therapy the to product as of label that to potential

certain performance of to quarters consecutive has procedures improve acetaminophen this over fourth a growth we the a and growth this guideline the Ofirmev, in IV in certain the product as number performance driven quarter. consistent, experienced this result may CTCL patients believe quarter primarily quarter, we in strong was by the Therakos in during favoring U.S. in versus changes decrease hospitals and quarter variability. saw on of as result sales Next, of in net a Prior oral quarter-to-quarter a from order

of efforts continues we our Our for of portfolio appropriate high for to indication see In will digit expand and on focus year. a relentless full across the business growth physician important level. the perform and patient well the at the this identification is single to hospital use expect the result capture Therakos short, area portfolio the

strong increasing in growth for we the Japan, U.S. have in to continued offset partially Finally, by competition Amitiza, see

We continue for least product be at year. net the the million to $XXX sales expect in will

likely in branded pipeline business, to to diversified company. continuing and plans Generics segment, pricing quarter into on portfolio even the to the we dealing while of beginning non-opioid this side some Specialty this in API due long due Japanese in decline this our and U.S. structure. were report with increasing to become to primarily sales Overall the driven another build growth see the net Moving In has will disruption for we our slight been our we’re pleased innovation objective momentum, biopharmaceutical year, of spinoff to transformation. products the of of management competition realize dosage and an biannual a stated suspension changes reduction With continue next

for the non-opioid with continued is end from with expect generic of to the We segment of the this likely a pleased believe will We Specialty majority pipeline be long-term year, the to growth our that towards poised return coming growth the opportunities full the for products. perform but low guidance range for business business. Generics

I to things Before the today. like Steve, turn call there are over to reiterate I’d three

First, address to and remove we diligently are near overhangs term aggressively working and uncertainty.

our we pillars the underlying strength strategic with and and against approves generation cash Second, executing business. are clear good of

by capabilities provide With over efforts. across and of our pipeline a continues Steve? critical data innovative pipeline to on various Finally, more transformation our therapies of stages call are strong and and to that, it’s the me development. turn R&D let driven details that some on delivering Steve generation

our science successful and This Mark. a you, technology organization. Thank year has for been year

milestones in in Phase several hepatorenal Phase critical to capabilities. two of reported Having treatment trial program terlipressin demonstrating August, to established testament to fundamental ago of Over regenerative burns. late Phase line a the our company’s one. we CONFIRM we X September, in top development the results tissue organization’s X last partial we benefit for the achieved positive line development X our pivotal pivotal readouts transition StrataGraft is the our In for organization And top an of with innovation patients programs. by for results driven efficacy our a only thickness have pharmaceutical of quarter, type achieving the two deep phase company support the trial syndrome years reported demonstrating skin

on programs. positive above now addition the of to registry the in I’d from for results our initiating milestones, Acthar our development and efforts continued like also the Acthar our summarize In multiple our pilot demonstrated data October. development to completed execution reporting X key study generation recently sclerosis keratitis evidence we Phase progress

Let’s first terlipressin. discuss

one. type and there affect clinical prognosis weeks CONFIRM therapies terlipressin characterized median acute threatening, a study liver States The than At less study is for XX,XXX its evaluated XX% or kidney advanced are a in three of survival patients XXX HRS-X X.XXX. very As is annually. disease than adults efficacy of with approved drug with disease in a HRS-X HRS-X complications two within HRS-X HRS United verified a no rare safety XX,XXX present, between lead time by reversal failure. has months. greater and to a of HRS-X the that and to life of with U.S. P reminder, poor The of Canada. in estimated the and met endpoint primary the value mortality

clinically avoidance and verified three reversal renal Importantly, relevant HRS-X function short-term of includes dialysis, improvement, survival. components,

early the our to We’re submit NDA FDA planning to in XXXX.

We Boston. to Diseases also about Liver the excited for upcoming are of November at American meeting opportunity Study findings present in these very on the the Association XX

lower the important the for Such objective that to skin by extends layer through product standard is the complex It's to epidermis, entire for skin to many be injuries of certain in skin. for and which the partial-thickness of for the this StrataGraft. the is to outermost Turning need damage wounds the the potential the thermal care the dermis, wounds. reduce into overall our Autograft innermost of are autograft layer of substantially part deep remember burns. considered

a on function requiring smaller involves area StrataGraft Patients three partial received efficacy served the treated a graft or Phase skin Results site burn thermal as the of show by an transplanting site. may injury, own donor at the Each surgical pain, a safety study X.XXXX. the single The thickness application months experience value trial participants area of X P healthy left and burns. evaluated autografting of compared skin scarring care. patient of harvesting his required who burn patients As two and in from her the wounds wounds are impaired to the itching, deep of with autograft the exclusively of autograft StrataGraft treated with pivotal with tissue wounds and uninjured significantly with that treatment the to autograft of control.

tissue first durable Phase StrataGraft predefined that wound exceeded three plan Additionally, results show statistical proportion threshold achieved to we significance. the to that the months for StrataGraft half at in wounds FDA X on a Based for data the treated of submit a closure BLA the positive XXXX.

for Burn We XXXX. to spring submit in in American meeting plan presentation these also data the Association

designed was primary receiving baseline MS registry, symptoms with measure the improvements from MS for significant months Acthar Regarding Gel exacerbations. MS associated Acthar Acthar to showed in Gel the at of that by treated for Data characteristics of patients reported patients as Scale assess study. MS the measured with two exacerbations Impact it

response with Status was sustained Physicians symptoms Acthar Expanded Gel the six Scale. improvement in on patients treated and reported the Importantly, Disability an months. also at physical based

patients other programs, for Regarding progress our our initiation X key suffering MNK-XXXX, liver of advanced encephalopathy. the L-ornithine to development disease hepatic with continue global the preparation treatment we Phase phenylacetate of for of from trial

seek Phase our special the to trial. the put alignment in to SPA to time of time Given it think guidance. find FDA the the assessment important program we further ability several greater the gain starts, agency X in this procedure. with a for months complexity it’s that utilization this of execute line of to should Though the confidence aligned our we’ve or alignment add ability protocol FDA’s to through Thus, confidence disease, the with decided the in with to regulatory provide trial may

VTS-XXX we ultra-rare the developed Regarding treat and to to neurodegenerative condition type disease adrabetadex, referred one Niemann-Pick as being one.

continue submission. additional analyses path are also to interactions as with generating FDA These We are to analyses response through databases. we all on NDA the an viable of seek available in

self as for to our in-line in of follow. delivery successful injector. the further new chronic versus graft our submission well Both Acthar continue also lymphoma. Australia be XXXX completed for both complete for specific reach We’ve disease with INOmax to expected advance expanding of achieving development Uvadex the efforts and approvals plans programs to ECP cutaneous been host to T Turning Therakos to delivery are with our as Therakos and developments cell in we brands, device EVOLVE, next-generation

our on preclinical their license to targeted their technology research compliment and with progressing are Silence compliment other we Recall, development to with early we up Lastly, CX based Therapeutics. collaboration two SLNXXX options license to obtained the recently assets RNAi asset platform.

also generation portfolio quarter of new We specific including greater the various the clarity been ECP over year. In the underlying preclinical to summary, significant collaboration been across data, allowing across the work gain progress benefit our in conditions. of Transimmune us and progressing on Therakos have with past our has mechanisms made the

will X the plan over on first to the terlipressin next major line Looking forward the half catalysts as of Acthar the the liver presenting as submit and for milestones StrataGraft full and AASLD also CONFIRM have we top lupus for well data we November Phase two trial, both terlipressin set quarters, results be to NDA the BLA meeting XX. XXXX, In trial.

the Bryan inform analyses certain may XXXX turn X available with first be Finally, post-hoc will now by that aggravated quarter Bryan? over further discussions to discuss financials. it FDA. key I’ll to

sales with million. $XXX net The brand morning, net the $X.XX with collectively net in increase of INOmax a sales of a X%. net X% net decrease $XX $XXX in contributing million. contributed net delivered $XX sales, of in net earnings diluted were of share everyone. $XXX products reported of million in good hospital of and sales sales the quarter million million an growth generating Steve, sales, and segments $XXX and Thanks, In adjusted X%. XXXX, per of we million provided Therakos third Ofirmev $XXX Acthar million sales,

quarter, of benefit recapture net as Generics an $XXX continue segment Lastly, increase million across an of in of net sales of we Amitiza quarter, generated the increase the from products. million in reported Specialty sales share $XX in to portfolio the X%. X%

R&D percentage with contained. measures of sales Therapeutics. the was our details net basis a which result sales XXX XX.X% gross and expense XX.X%, to profit of quarter. total me was as Overall particular for our SG&A company payment SG&A compared by on net compared significantly decrease XX.X% product percentage our to as by the percentage Total Adjusted XX.X% Silence let was a relayed XX.X% points a in driven down Acthar. is costs collaboration some company for a changes adjusted Now the to driven operational of at net ongoing share a as in as mix of company sales primarily upfront of as

our free operating year-to-date bringing operating and flows cash the quarter up $XXX liquidity, flows million $XX cash in to million, cash to $XXX Turning flow the were year-to-date million.

upfront certain The third despite and were capital legal Therapeutics onetime the certain Silence quarter cash flows working changes Specialty key as well legacy achieved including from expenses DOJ as Questar a and in segment, the Generics payment customer payment, settlement.

to our flows and $XXX free levels be year. expect cash the for XXXX continue million We to exceed approximately annual

lien And of which in XXXX indicated, with the private mindful press an maturities. exchange be exchange Lastly, offers their of holders earlier to to holders be exchange including we near longer maturities. our new notes, launched release issued debt opportunity this second Details our Mark can unsecured we these morning continue to term holdings into have as maturities of note today. in offers found our

currently As comment open exchange call. offers we’re unable on to are this the further

the at nearly Acquisition. Sucampo billion, $X.X reduced debt since end the quarter XXXX first the Next billion by having was end this been quarter of of $X.X following the of

leverage times Lastly, the debt our slightly to four as in published our website net quarter higher today. third on grew

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

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

comes Schott question JP Morgan. from first with Our Chris

now is open. line Your

for could that elaborate product you I and focused Thanks Acthar. the outlook on just will XXXX, further of question a we question. data ultimately But for to are sales much you in quarter. My on very time. on for reimbursement realize level further and high for that if the stabilize this some And Great. business. growth on that monitorization In it saw like sounds readouts it's going meantime, seeing we data the the hopefully pressure take you're have was

another before much. believe to data consider thinking from we down on we Or the So start very have hand? sales the even directionally, in be should this already stabilize business to reimbursement Thanks step be you next year, able you'll about you Medicaid dynamics? do

Yes, thanks Chris.

couple with on have giving situation, to So due of is we're one that sales we not think, we're certainly into you points, to to anticipating at XXXX, but on pressure even going the the soon, expect though hopefully a key moment, some regards to I Acthar guidance that we're would which hit be resolved XXXX. CMS

The second at predict that point on impact One we're patients additional an now so starting readout of reimbursement is that to pleased our had level to the RA though, enabling prescribers reasons. clearly of fact several are dialogue challenging likely new two think, I with this that payers. the a us up. datasets to prescriptions was we clinical can very is the have are course definitely Acthar with positive point regards we to from one that different a is very, that's and data positively. RA rheumatologists And have refractory trending data for for with very Obviously readout. also at see It's to

lupus which clearly registry well as to In as also uveitis is imminent, the and MS trial positive, sarcoidosis. readout addition the but was

and so likely to to go think clear outcome other reading we're out by to very real for positive of of Acthar take And it's be studies going again impact prescribing. those based said, likely trends another studies us of to As readout couple encouraged the a it's we the also data. that's are so year positively, the to have on we've or first with have positively. view we always Obviously a on going think where

Acthar those that we're impact of at quite And whereby payers now reactions reimbursement. of potentially had which we of for stabilize these customers some though what way with certainty going first with but would and are the it INOmax. thing differently a of the discussions importantly, forward. And type the what positive, other are we we again, large positioned to capturing we be is prescriptions And similar model may INOmax, positive well initial to growth. be. doing I think, The that's noted And Obviously we're good these payers payers model, called for looking of proposal. a at to different something is term facilitates with going the reimbursement combination gives discussions from longer new and for where and early most that And our budget the today around potentially with engaging what then experience all degree a we're do revenue. subscription have we we've regards with a reimbursement, would to Acthar of very very data then that had we've do reimbursement things stages, if what's

do In creative as that's of addition advantage we at self-injector that, we development. for the of have significant explore in payers to some could that prescribers these as reimbursements. to look more and Acthar that think we potentially for course patients ways And be well a as

as story data in the it's readouts the be to therapeutic But really areas. more to we would key moment preliminary initial summary, over for positive. next the trends little to we going months, positive continue think at we get are the We feel project. a in more So quite product – XX told is

Operator next question please. Thanks Chris.

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

Your line is open. now

the out possible? you just but about a the if strategies considering Hi, initiatives give on Mark states any the a months scenario? then worst of maybe at are the Thank that on comment cases timing decision? three envision good trials? number going opioid the significant a of sort CMS you considering the And steps I a you're bit know Track lot litigation, are little on just the next of pending how with those defined maybe of comment are playing has depending other point. yet? And just the on that in And us MDL next morning. there's of the Ohio X What of And and you. different and what outcome the the this been restructuring just case sense

Yes. Thanks, Gary.

the would of spasms, some to outcome the that to and might next opioid Track if Clearly you terms Acthar a as X March, strategy the decision timeframe the term But because on us impact regards XXXX. strategy strategy overhang margin goes significantly type some change resolution resolve of our has decision have can up that Acthar. which we of just York, objective I State contracting around the there. of the early settlement. for in X engagement fundamentally the settlement with model is the Transitioning case. payers see say York largely data whole we're tied that’s population that discussions would considering this, on our marginal a in think investment to a for discussion global But driven on which Ohio we readouts for is in the much just these scheduling is the how the so our for models very and in in least litigation, would a unfavorably a around hand. and range so be imagine, come a expect innovative of that options the opened combination, reimbursement we Ohio go for I the the in docket So longer out, is stages the the We really could the CMS the And the is us New Track with more model potential around Medicaid infantile discussed. with company. cases hand on really and after Acthar the being for of CRS April on the is significantly case we decision, Clearly a of in exists in strategy that again by in the that global New the that strength to cases and and products payers pathway data data. those for play two Acthar of and engagement the the are data at really things to the type eliminate of strategy currently

ground that obviously separate global objective that and to market. achieve business generics But do simultaneously range of We look of to yet to again or We’re lot this to a to thing negotiated a We relatively the communicated an engage short there's resolution lot those hope the a to more in in needs in to close considering resolution other a situation try that lot whole us But uncertainty. two again time. outcome. of could cover, also global separate a in propositions which to there's we that come the concert believe that of there's have again, continue in and that resolve negotiations ours. come been brands before enable is be a in we're we

Great, thank you.

Thanks Gary.

Next question please.

with Bank Your next of Gerberry comes from Jason America. question

open. now is line Your

Ashwani for Hi, is Jason. Verma this on

color Mallinckrodt Ohio higher any why can to provide paid litigation a that opioid Track MDL relatively X the on is settlement on question you settle So cases.

as just brand branch the that about is well? investors should genetics or business Given this think to reflecting number pertaining small as the

Yes.

the Track the necessarily to So in path cases anything the regards I don't think size X resolution. the towards ultimate specifically with into the global of read settlement you should

As we've companies think, read here and low the I probably currently amongst ours minimal seen of the of settlements was a there’s that. towards range end at best. through But been is kind of again,

get cases, to can we resolved. time settle us that. those those still a there's And we said all company come the negotiated. to I do objective to consider We a we'll as negotiate options to that hopefully And resolution. able earlier, we a But pursue to that has this range as was continue think again, provide global forward. to to appropriate Our be and lot of of be options

you. Thank

question Thanks Ash. please. next Yes

comes Our Gilbert question next SunTrust. Gregg from with

line now is open. Your

much you that way there could decline business a Hi. and on be versus volume? is at more Mark, whether the us the the contract multiyear was and different contracts INOmax, how on of the Acthar price these of And of to any pieces helpful. of Thanks. is hoping of comment point what that by you can can I locked the this kind for us was pricing in tied portion regardless landscape, little type, would sense business you give quarter of bucket in in a competitive

Sure.

So with than in here product the was regards that important earlier signaled of we I first. nor based in year really what's that around volume is Acthar’s down was our the price And the to it performance more half in was Acthar be second think, range quarter, uncertainties on the the virtually again, likely was there. in a neither it

case. that's continue But there's any we that perspective. in the the that think to that in revenue as the Acthar’s year change to we've believe quarter We our remarks, don't from full prepared said

very encouraged that said rheumatologists. by when response very we corresponding generating good prescribing. as the – fact, however, positive presented, are a but encouraged I by response particularly We've new data earlier, with we for prescription is are patients that RA refractory historically very typically We get we fact in the seen are that

as the in single a that's on business and that's get us to that with Given beneficial articulated year yet that's time. of general, contracts, a for some increased at well course very an prescribing we're successful as depends again, contract. the range how of typically depending response again, the of what not on for time is we've sense now years those which translating payers. so the a proportion they just slower public we call in is yet there's in earlier, years, going an through contracts direct customers. readouts yet the seen customer can But been multiyear or our is two rheumatology. contract RA both is belief given both regards continued And some our form the of to or And is why our data business to again, any multiyear payer type INOmax to a our and that of range But sales. of of multiyear of in under impact a about play out, help unlimited Typically does way much of point three a will we've that's take strength patients With that negotiations looking of a any I up as described And the so. the And those application, that of thirds lot type the here subscription good filings. contracts. the in business seeing use work it at and that we with that's are somewhere by model sign data,

Sometimes them, associated general beyond point. than about not there's again, can But those of concept this they say I don't. have much kind that at it price sometimes escalators more with

Great, thanks.

question Next please.

Jefferies. with Petrone Anthony from comes question next The

line open. Your is

was for mute. Apologies on Apologies that. I

of later? improving Again, has of but more where Just less two outside indications as sooner category rather on offer of and or there the on the the within on the the strategy. me. pressured particular within Acthar you're seeing payers know than I the is renegotiate indications, just On indications you any from Acthar perhaps there pressure? anything questions healthcare been those particular see data this exchange trends on is in can one infantile those that where notes. all And with announcement you spasms anything One on maybe is

participation is Thanks. particular for not If exchange offer holding after the the alternative on are of expectation plans maturities? the up And in the high, participation? is RA what readouts? So some data for the what is the

I'll to exchange. So Anthony, it the Brian the, to take me turn let discuss Acthar question.

year mentioned we primarily really where as on prepared the again remarks pressure been come for our has has So, plus prescriptions. longer for the Acthar in last duration

in active actually lupus, adult arthritis, disease And clearly products going least therapy. patients patients again on days benefit like additional patient additional be But that. using but being administrative that's in an essentially patients just in despite have a if days in order course perspective. shows multiple I this that. of the to therapy shorter where at the Not thirds that's patient to data indications refractory beyond have to what of this is every XX typically payers the every again with be there's be not And from benefit. Acthar, have an that benefit syndrome. trying really so or pretty new in typically to interpretation RA patients. benefit or typically challenging support the RA asking in go can of highly much additional most the or refractory about patients or takes benefits, about from is have are therapies. really now XX which category the is who discussion therapy, RA as in which of does pressured you have would And patient study, let not the determine payers a to two burden it benefit. the of product days think on best our to after to XX your interest do in part going still now prescriptions RA with whether like we They see And appear nephrotic But me restrict experts to re-qualify some those cases, is highly from saw the actually rheumatoid of to or case data So payers sarcoidosis, to

data we So prescribers forward, because that's look likely the to discuss is readouts that’s for duration appropriate and what's greatest are payers some again, going the benefit in Acthar the these able appropriate result to for Acthar dosing who as why patients. patient, with we're at important

Bryan about it pass on talk me let the exchange So to transaction. to

has my exchange XXXX. full SEC filings Mark. comments what the into we’re Yes, would with of to second comment to lot reiterate than everything said, which add the throughout unsecured exchange just Thanks further longer really pushing encourage in a to maturities a our the said to we're lot out notes in debt it. memorandum, I Like to morning, SEC would this read precluded lien stack everyone I which detail notes said. prepared what to the offering really of But filings. I detail Yes, our offering around there's the I

Thanks. Sure.

please. question, Next

Thank you.

with Our next Jaffray. David question Piper comes from Amsellem

now Your is open. line

Thanks.

get here. So on how the sustainability But missed about a longer-term wanted your to I from business. as thinking apologize I generic you’re sense commentary you Mark to if

what I recapture at that lost what realizing to your views and not share about an is look there overall that’s intrinsic opioid on heavy talk guess You are here, are on the barriers me. And help entry to doing piece, the what not sustainability? here? to that piece? pipeline me with for you. if are would could just that ANDA you also non-opioid cultivate an secondly Thank opioid then And you But helpful? be some business, that as actual but you So

Yes David. thanks

believe the of was the minority treatment, about its out of a to over Much actually proposition there portfolio. pipeline start contract developing core, experiencing we've at when manufacturing viability we believe a across the business, share just the controlled pipeline do, this in things term, that like products area longer pipeline. articulate pipeline was business, contract the quite growth business a XX%, that vectors actually We've But And substances, we be which a in most And the time. we space. of this as And primary as to we also is probably so. to may the this business business. heterogeneous for includes reasons: business most well addiction a business have the or will been of we couple part already is from introduced detail. has strong are some do growth actually will result in are couple third pain may are number long-term spin a secondly, which Those that of may expand this are opportunities to business. in for we be products API other of the for but is term acetaminophen, be mostly that a as But couple one, business that pipeline products. of a coming greater for So non-opioid and are manufacturing captured some longer of quite think we are be two of One controlled in today portfolio, And non-opioid there the this years. look actually the pipeline very while clarify, been time. products pain for majority a currently of in then manufacturing of particularly mature things Opiod forward, treatments, products a products. of couple pipeline of and substance value actually it as ADHD the of

thanks. Great,

Next question please.

The James. with next Elliot question from Raymond comes Wilbur

Our line now open. is

customers? two Praxair customers the Good on sales launch I morning. on Lee Elliot. Lucas for focused has largely the you questions. Praxair at all? is INOmax, On current believe do This is impacted have And new or

select actually they they doesn't launch appear knowledge, What doing does of we it type But on based done best may still, haven't marketing this accounts. any national at Praxair in is few some our a point. be it what a test observe, That’s appear that launched. has of

it In ultimate marketing, options. or ultimate medical that they're much they different terms testing launch, it's they a test to – ultimately what simply if of range launch they In as how understand the because difficult appears of as we company you Praxair most industrial supply where keep hospitals gases. are, their customers with mind for is expect which might in an that can where determine, they're is go, part to they gas going the

are that So they moving. be at initially where appears least to

if believe enables to with customers, are to INOmax. particularly believe ensuring it's by those that INOmax is think comes total that fact there's reduction that us requiring the in competition total brand we of gives or mind we total have Praxair separate that Even portability care of out there not occur, on be focused when technology an INOmax only offering, developing anytime based keep of are generic within moving offering we into does it’ll really a to significantly opportunities. likely offering brand accounts have to covered We in model term, sticky. platform case the and the EVOLVE the that a we it believe completely occur put in offering completely market, we baby and service the is This that to We separate Whatever is potential not it hours, on very are then particular ensure And understand. interested where swap the longer needs are because NICUs the that superior valued we to to really be market I sticky potentially provide, the for business care basis. significant on offer. our things opportunity which quite air, what a couple be does brand and when human think product. brand to to us a a greater expansion sorry, four but that important would we're customers quite largest a we in simplicity a offering highly our a the that

some these business the bumpiness while may very I does this near the just sticky INOmax a the reasons competition all in to For reasons for come, likely all see us. is we that in described, we if be term Longer-term for sales.

Thanks Lucas.

please. question Next

comes The Trucchio Berenberg next Capital. from with question Patrick

is line open. now Your

quarters of Thanks. arbitration. And My I'm question should or one paid then an this, amount funds wondering is you by or early XXXX Good is other related over what way dollar could upfront, a knowing ruling CMS be to out possible probable? do is the adverse, the on if number the event? it And years? end morning. we XXXX it of or anticipate is a or decision what or possibly

to to a some bit particular of that regards be questions depending I’ll course we on and of we've be on you helpful timing it comment for this to in on put to to look at little And the other speculate the yes. of of regards on other at going With depending us so ask speak to together in terms plans Patrick. Bryan, of this not just the timing it's this a I’ll that are with could outcome, later, But impossible it to the It had the But range specific with point, federal uncertainty. longer. time. come timing, Bryan is you may any of point. difficult the stuff, Yes difficult, first comment have a if options on what of CMS year, would any be. it's might timing settle to the than could into the The judge. the be cases ruling come the resolve Typically able could predict to very these be series it outcome sooner try certainty. quarter of but stretch hands ruling could end by or to the

Yes, thanks Mark.

afternoon. update back wipe be will essentially that as our we far Medicaid exposure, XX-Q had previously revenue worst as out on would So would that disclosure million. that and year had be to reset and to the But retroactively We base AMP if essentially that disclosed this $XXX would XXXX. case we about the estimate we

business, Going so XX% the forward, we million disclose Acthar that we about prospectively. of $XXX roughly think that's

So worst the that be would kind of the scenario. case

Okay.

mean, I And think I if out is ruling the that. then most I for a there's likelihood appeal we'd I exactly that the be mean work is would safe guess, that would unclear, how that think, I bond right. came likely it in the paid, that to it's worst unclear. high say scenario, how case

the So I guess how until it see would be still we ruling. unclear paid is

as as Bryan's uncertainty certainly assume this event sort was think, what of to done a and in immediate the of there's uncertain out-of-pocket obviously to ultimately it's And look that bit like. a a request of case, that going we're that what looking point, would this Yes a an we Pat, stay, the just that fair through I to But to think worst through the limit for to point of like. look to it appeal some at expense stay. I at payment lot look we've would a

Thanks.

Pat. Thanks

Okay, next question please.

comes question Fargo. next Our from with Jacob Wells Hughes

open. now line's Your

variability. I Ofirmev the was quarter? called decline weakness some comment just expectations. and on, fourth I out this we know Hey, quarter below you order this a think was for how good could morning. But wondering how should if readthrough I you our about and quarter the think,

Again, through the product. commenting that I read wouldn't not on that's specifically we’re anything. why fourth we’ve read quarter, for each reiterated Yes, individual through

quarter. the that portfolio on in growth unchanged quarter-to-quarter likely is is portfolio OFIRMEV there the digit performance range confidence third goes is hospital here. in single the to It in the deliver specifically high variability by that Our the is

growth that the for helping a the target OFIRMEV with to of such oral And one try associated sorry, to I previously. in we of impact of great pain the and replace order-to-order looking surgery. seen that some product we seeing is with confidence seeing again fourth we going reductions been variability. going is are in is accounts have here primarily accounts in – though see are we growth typical But some may the manage use area. times that things product Many quarter. some And physicians to We've think pharmacists variability are quarter-to-quarter ways is where OFIRMEV it has many some acetaminophen. initiatives of One some what's on in think success in the

Great.

just on on it Okay, for anything that reserved a the want CMS. just that haven't uncertainty what follow-up suit? confirm Based is it you could be, to on then

not We've anything. right. That's reserved

consistent been the obviously, we for of couple the last And quarters ruling. we await that's since Yes, filed. now

Thanks Steve.

question Next please.

from comes with Annabel Stifel. question Samimy next Our

Your line is now open.

Hi, the taking thanks for question.

you mentioned minute, quarter some impacted and multiyear the utilization. that back Just for on unlimited INOmax the a by contracts was

pulls So kind why and going StrataGraft then do there? terlipressin outline separately strategies investment you us launches? of going fourth to your Thanks. some filing go-to-market are be be and you these pushes and broadly to to going that's in recover think you're for would fourth the normalize is allow quarter? within there what this of What And that the Can sales for And it to now. you how in quarter? tell and required capital, months can

underlying good Thanks demand, the it which strong the And seen that and as have good oxide. mix nitric of Annabel. very as underlying strength two by of for we product business. we’ve Yes idea the it’s of the One with driven is measure in real very the comes regards is a things. to strong, INOmax a how is consumption

come with actually quarter way the quarter contracting expected what business, of would multiyear out the would’ve that’s pleased quite our arrangements different mix The was a more from for contracts, those of thing that. slightly what important we’re volume customers that of and contracts. the a it. have we good revenue more long third of a in actually which different we is expect of shorter our saw versus in coming term some in come quarter. And exactly translate And into different can So doesn’t because would that sometimes we

expect typically on we fourth see quarter. typically that range for INOmax lower quarter bit product. things to do to continue mid again, in the see range of a third we normalize little we in for And these growth overall, digit as this mix just – the of the bit the So for single would

we So portfolio the have full be that mix going single-digit we the the that fourth quarter, for very again, expect in and now in which, year. high business to confidence the normalize good is the to range

is to StrataGraft, We and we’re talk our with terli these very focus quite of about it’s great to Speaking on about underserved both and mission, conditions. the that of products because that the excited in And care burn think these well them. mission and to products StrataGraft, go particularly in of in in that case hospitals, critical patients these centers. right severe space, critical fit

the selling Ofirmev team – well in the overall with in INOmax we as investment strategy the place for already is to is that general with Our products and these both and the teams. have as regards today, part hospital the access support for most direct Therakos support

combination believe the So we’ve been have be year sales the StrataGraft peak quite sales we There estimates forward for think truly, we should have plus a long-term these we That’s that will, clear peak year expenses we also course, products, that then to that launch OFIRMEV. of for some exceed of that XXXX. at very in. really we peak two infrastructure the look And thing. can in good laid

the general, on additional expense infrastructure minimal launch primarily relatively in be XXXX side. expenses with in investment will to fixed the So limited

Great, thanks.

Annabel. thanks Yes,

question, Next please.

Parekh Our Barclays. next question Rishi comes with from

open. Your now line is

How you are questions. doing? two I just had

balance issues if the in in that in have is Acthar you’ve second, And today. know terms constraints of And facing of of step-throughs the prior with to with exchange, what documents. Acthar, said you million are you’re sheet particular your same I the the years cash and exchange, given that ago? know you’re that ever of few similar of the Acthar. as terms an a on don’t filing you’re First, I on to $XXX payer But exposure of you the authorization on the today it that payer? in terms saw with the dealing your you to terms And or

But million the have to billion the look is better post going you your you million ample pro exchange. April add calculation, $XXX an just of By if trying will to to capacity? understand amount my limit that probably $X.X subtract that $X.X pro forma that or Should secured documents another cash. I’m lien? to had that You like by what $XXX your of maturity, new do time from your so to lien billion. going Or of be the all $X.X secured is amount – participation debt XXX% number, so we you could we first were first forma And of just issue billion the exchange forward? can capacity

Yes.

So I’ll question Acthar and ask on exchange again. the I’ll take to Bryan then comment the

the has set that a actually Acthar XX for the to than patient more fact again, a patients now requalify on can arise we is regards that on an quarter every data lot that with and in shortened from once But and in, payer. to administrative on prescribers. now refractory we now there’s XX primarily key when in potentially, keep payer therapy initially seeing keeping think, they’ve they benefit clinical Acthar to incremental the robust days, So being as again, having therapy benefit based a focus with additional a was back large least a burden. this have payers those from longer much we’re more started reimbursement, these months. that physician what accrue the significant able primarily again, data supports to really with that new And on makes at sense started that with patients with, that patients determined now can indications, much trends six network like XXXX across of patient to prescriptions it versus extended different similar I XXXX What’s being RA, time are days, discuss third longer-duration by actually

a for with change payers a as having early landscape it’s two over are of days, benefit why we’re the that’s the years time to the we’re we that’s a ago. models, reason and contracting innovative payer reimbursement. the having some that we big had can time the discussions think forward also why certainty more innovative, we different value-based believe come difference subscription the with again, tenor another now And So than that to model, And which the with such with we but the regards we’re contracting data again, conversations holders. right taking for the payers. intrigued this by type could model provide patients, budget but Acthar It’s think combination and initial of on

Mark. pro Thanks, the capacity exchange certainly and about already love we’ve as I’d comment secured what can’t talk really to I forma comment Again, beyond said. can’t on well. really

So I’d a details has you SEC around the exchange. really to into filings, lots the which of encourage guys for dig

of half hour. Thanks, Rishi. Looks like we’ve we’re one coming got maybe We the to more the time think bottom question. for

Ami Our question last from comes Fadia with SVB Leerink.

line Your is now open.

questions queue. my onto lot answered. two back for follow-ups thanks Maybe a were a since bringing Hi, of the just quick

negotiating that year you injector of how calendar for for the Acthar? be that if that this subscription regards volumes Acthar, could of can talked some you the help for, Acthar models think you You to successful? to structure stabilize talk for of self And about be which with were type would some for about you. Thank potentially the sort

certainly. Yes,

to supported concept that’s We patients with what’s uveitis, our around take but start negotiations today as would inject that’s a early model, particularly to know those. to them. And excited something be it’s vial our like payers, include that be includes this its One, regards by lupus, intent refractory if, again, Acthar dose about the again, multi-dose to clearly time Acthar gotten this from effectively one, requires fact, product, vial, quite sarcoidosis the a at a to with data. I a say data. to With for and we’re opened and the subscription this model. point, things could the But up discussions is the it’s out, which, of RA us five that it’s these model regards subscription a because self-injector, discussions the quite of and can play those of range takes supported are So of going successful with it bit attention the would to today presentation. indications, doses consider on negotiate because we in draw

that’s it’s dose actually a unit a more some around essentially, So self-injector, longer-duration to conducive much with patient-friendly, of just these more but much doing therapies. contracting innovative

you weight contracted use you you almost unit have virtually, have vial, a Acthars. a the would flexibility spasms One around could adult And packaged you for the of negotiate investigate need population, pediatric infantile and to could a gives indications model. and to patient effectively, two contracting different vial. exclusively dose be So self-injector. value-based very which multi-dose where other in by all It and be amount dose therefore tremendous multi-dose in

there’s eliminate the think us, with that enable intrigued regards for multi-dose would some inherently, to it. the vial. believe, probably would that to with presentation waste model more we’re waste a an with have occurs prescription of other the this we by the I effectively particularly And there’s this be thing you vial, some multi-dose to opportunity associated is much efficient. Whenever

whole dosing in and a limited vial. up the that range with way So packaging, it multi-dose contracting we’re we by think a patient-friendly pricing, of opens

drive focus indications which growth, in see with things, some in our enable conjunction of could RA, is. strong some in where really these those other data, of All is we longer-term like us volume-based

be thank joining also answer everyone the us throughout questions final everyone. like for Thanks, A Have any a today the available Ami. day this to This be a later of and call Thanks, follow-up will on morning. have. nice is website day. you available to reminder. I’d may a replay

participating. gentlemen, today’s you Thank and Ladies concludes call. this for conference

disconnect. now may You