MNKD - Earnings call 3 2023 | MannKind Corporation

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Operator

Good afternoon and welcome to the MannKind Corporation 2023 Third Quarter Financial Results Earnings Call.

As a reminder, this call is being recorded on November 7, 2023 and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call until November 21, 2023. This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainty, which could cause actual results to differ materially from these stated expectations.

For further information on the company's risk factors, please see their 10-Q report filed with the Securities and Exchange Commission this afternoon, the earnings release and the slides prepared for this presentation.

Mr. MannKind Officer, Executive like Steven the over from and Michael to today conference Financial Chief Binder.I to us are Officer, Chief Castagna; turn Joining would now Castagna. Please go ahead, sir.

Michael Castagna

profitable since for last Didi. you, today. quarter X to on became more in product turned and life. our live Thank a year over faster help and everyone, moving better this losing first Steve people Thank We've $XXX joining company as to million I and a quarter from you, It's live us patients been CFO to help our history. MannKind and than we've helped XX,XXX CEO years continue our to well our is mission a pipeline manufactured ever over we

this royalty think orphan we've $XX of the our about progress on aspects highlights Tyvaso and the million company. manufacturing In $XX we seen great revenue our clinical we've million. made financial of of over and space, quarter, lung As

MNKD-XXX has as trial program leaders this into our have a our clinical of last to CMC Danbury On the when in nintedanib KOL get first to I possible. MNKD-XXX, quickly and in 'XX. from and Phase from we're program, as progress continued our the to has positive We IND facility our learned to call in had half we inhaled very our its filing humans first partnership here on cannot excited position. better pipeline, starting an Feedback been of this time.Our moving at just and Germany we in earnings manufactured came our fire our successfully a in batch in be record

quarter year This our our positive that contribution. year-over-year. ahead QX this was We of by million in we've first On goal. XX% and the Afrezza growth is business, $X.X achieved made of driven our endocrine QX expected quarterly X

finish they prespecified analysis, are INHALE-X diabetes hit INHALE-X, the these in future trials pivotal on the and run for of the trial as to paying or begun now filing was the We progress months up about an in And talk achieved was at clinical when we bit $X for trial were business. was to and on financial, X interim we down think more our continue have not. X which exciting we look determine our about we million that we progress this expect to but enrollment trial. midcap also made INHALE-X, debt. our this of As it, INHALE-X, a net ahead XXXX.As hopefully incredibly little income we've On appropriate if super size are planned of the enrollment enrollment. excited and I'll XX% we

our so flow free continue We reducing drive growth we cash are by way continuing future company to up greater can This to we value. interest our expense. shareholder deleverage drive to

As at quarter number the the some from may end were of the in and we look Tyvaso, Unither. questions we last recall $XX what from when many at around you inventory heard million QX happened the of there

quarter-over-quarter continued including $XX And that plotted a we what was million. so here

in Now what our of breakdown in show would this rate put is, often royalty it's launch and get I year. is like continues hopefully what last to those that to look, bed we as forward between royalty around can rate on for very manufacturing million The MannKind terms mean question quarter-over-quarter to transparent our patient $XX next we of since to when shareholders. would you demand $XX million you strong the go be sales.And I

efficiency of the build market production patients. and half second out, you to improving And new for showing expect the in as many inventory impact our we as supply gets on As ability look we come exit online XXXX, and come. wrap positive years XXXX up we expect to for bring UT new fill/finish come hopefully IPF growth to to more our to more a their year upside trial to capacity bulk next ready continuing for

that MannKind year manufacturing addition be out, transition. capacity will $X.X to we know, in XX,XXX As any market XX,XXX investing make you'll over with scenarios can UT them you what XXX,XXX we up can supporting planned.As our to a well look We're duplicate in and forward to extremely through Carolina patients serve patients in additional supply see can can facility XX,XXX our and to that to upside IPF manufacturing build that is XX,XXX additional the billion efficiencies on and to to CapEx grateful the United we over without manufacture. look we there to we all North able is

of made IND. top As is ready since the first we in Tyvaso, the on This back batch MNKD-XXX, who to the progress top we've the of for time on getting of in turn by our work did amazing team pipeline of our record fire. buildout Danbury this

all our salesforce internal first this our XX% are of in the main we and relatively and/or in changes in and you year to insulin year-over-year Danbury to on was see here with comparing a us feedback which beautiful the quarter not to has a year nice picture the data The see next year Afrezza, see well each I we system in into decreased months bonus The do over market of flat focus QX bridge doubled changed our tox now on X and as our of actually 'XX first so Medicare I'm II/III to decline. and to chronic X noise our insulin months Part change various profitability. here on Number insulin put moving track of marketing new one at self-driven. single-digit XXXX. team X noise, may since not to of for part you we we this But is do T&A, incentives D product you expect territories. Danbury drive made was to over we has in for infrastructure of QX, some impacted to Afrezza, can On It's care up the impact aspects But lot our of QX place the hear all strong.But we've or that that in incredible to We the nothing the line, health our Thank small having FDA coming market gray year next but one, Phase our really us significant a the off QX over $XX versus year. merged Afrezza you And here's see you in to lot to be last here they our production our had our team California set GLPs the this to slide that here to to MannKind can year-over-year everything XXXX. 'XX of impact excited our the trial process with vials to salesforces change to we and work.Now 'XX IRA X,XXX when growth. as in first by is overall is quarter may design government. of can consumer. start GLPs put structure. line. driven second protocol the much QX on with final We growth about program will as a from team 'XX, year in we of the the close the growth to look if impact launched significant

originally As not launch.As insulin built. projected. as we start we've is whether trial. or have up or with dragged refocused CGM now has wrap our X be expect Dexcom realize, pumps founder, the back to trial to been may met innovation on Mann, and we outcome kids, for diabetes INHALE-X, positive size One it that prepare of could We year completion we our where on happen length patients needed that happened Alfred next more sample most Podders, in this is we this type the E. and and it's Omnipod this very pediatric the with you this would can may trial

where switching AXc also we're As switch and the of years running pumps system CGM who latest half from which record in I X AID away care, than the diabetes an and here whose INHALE-X, patients later trial We're X. this would are on have of insulin bridge largest of time. AID the type with one people are is less automated GX including is in using over we standard to the trials the thought in including XX technology XX%

to hopefully control is can less show the card schedule and decline. going can we you ahead a here Flipping forward and well daily are this are maintain how abated above has QX goal whether X-year goal, to at you after you and use you QX are sites how releasing hypoglycemia.These Afrezza in or best this of tier control or improve been looking decline Tresiba year. of data show So The top a next and in to V-Go. with V-Go to over

the improving for XXXX. on focused margin are We

Steve, to changing now as process of to rebates. guidance and in our we'll XX% the call because you we're started As negotiation. will We've mainly middle went our hear these the provide and of gross contracts from of on nets them improving XX% next from

and are Kaiser with on now some DME However, PBMs. and we've working the early the wins had of suppliers some

this With watch we turn drive V-Go, you. continue I'd demand go the to to Steve. we like to So to Thank forward.Now margins we'll believe closely. and over we as continue can improve it

Steven Binder

select Thanks, which to consolidated this Mike, MD&A SEC by filed reading XX-Q, Please in afternoon. and pleased review financial I'm supplement quarter financial good contained afternoon. with the this XXXX and statements third our the call was results. condensed

the at bottom revenues the the Let's total by start at table. looking of

total with ended second quarter XXXX third the launch period highlights XXXX growth to and the DPI May the the our Our a which months the business, same V-Go extent versus acquisition and XXXX. subsequent included XX, revenue XX% XXX% Tyvaso results for product in X of and XXXX, revenues lesser quarter from endocrine associated the which grew versus

UT. revenue, price royalties $XX was sales revenues of revenues associated as million which million collaboration $XX services $XX to in Tyvaso sold of Focusing third Therapeutics. over DPI million primarily a of recorded continued consists the higher we strong product. the Revenues product on manufacturing the is XX% from related year net million the demand quarter and $XX result revenue which collaboration of of This at revenue earned grew patient services XXXX, an and of with our United Tyvaso of with prior of more totaled collaboration for to in DPI. We innovative and $XX million.Royalties

DPI. period, $XX first million representing collaboration of to million compared our patient For XXXX demand revenues for total with from Tyvaso XXXX for the as year-to-date months September $XX were the UT X strong

the Tyvaso included of period net which X-month in and second start of XXXX XX% paid first down by TRX and higher commercial growth a million patient growth of with second the XXXX, the midway quarter through demand to Total compares million. growth revenues growth of commercial driven price. lower endocrine The MannKind was mainly to a of of table the the a $XX the XX% product year, fairly rates. $XX UT net Additionally, consistent year toward underlying second by rate the XXXX $XX to business. million Afrezza manufacturing our reduction quarter our by was growth launch over and with of quarter.Moving end revenue endocrine were the

patient to of more September million due the increased adjustment. from V-Go XXXX, increase to For growth related favorable with level versus lower XXXX. mainly revenue period underlying XXXX XX% gross-to-net were lower price primarily demand X-month demand. quarter a paid and XX%, for third ending the of higher a the XX, volume TRX Net Revenues $X from XX% of was was patient

XXXX the downward the about quarters expectations. basis so business of TRX ending through increase are same each we by X quarter a September growth of our source period XXXX in this V-Go the The of from X-month for stopped increase a primarily is of last on graph against However, it shows been because XX, like to the XXXX.For quarter mainly XX show is the X the third quarter-by-quarter over from trend dramatically to and XXXX. next XXXX X-month the have related executing amount comparative. first has the we how on We slide revenue the changed the X-month purchase XX% as May has versus of years highlights first our how of

of UT second call earnings through Mike second DPI earlier, levels.And quarter patient Therapeutics revenues purchasing since our the the been get out in held $XX quarter pharmacies royalties have fastest-growing inventory the related revenue for reflected As DPI quarter their during and growing launch specialty then quarter steadily that approximately the pointed from enable last management contractual stated million call week, Tyvaso that source the portfolio. Tyvaso the in in third United the third to to generally to DPI product them Tyvaso stated demand. sales

associated chart the quarter. million, each or the the quarter the the denoted line In with for This our pharmacy in of which by not our not have Based and bar, quarter reduce straight royalty on see XXXX rate with the have stocking to approximately the specialty do pipeline second demand recognized quarter, from growth typo. earnings offsetting XX% the royalties, Below which is per the quarter third share run of current increasing we royalty have graph, We demonstration over and share on have clear of a related represents a to earnings for third Inventory the plotted the revenues, falling associated impact we fund a therefore can bottom debt. which expenses $XXX any of used the flow loss you per cash I revenues. $X.XX. allows

senior gain be XXXX's GAAP quarter breakeven expect income adjust pay of on quarter, pay to third beginning second to and contribution. its have some DPI We we plus non-GAAP of expect we the $X income it while stock per In quarter XXXX, endocrine expect a we continuous net a of go obligation the continues income of GAAP the additional reached on noncash to expect in year-ago foreign XX earnings GAAP we break loan financial operating and I then better secured items where XXXX.As our loss a now of of period we at expect will out income this next we following items loss GAAP significant be to to the of period, increases to its When In million impact bounce a see looking started positive we P&L. had growing even basis. this for currency, to our forth of to X share column, on based unit with year to debt was earlier, a debt cash a and pay flow. quarter call a quarters GAAP have of a conclude the million. the or $X for quarter highlight and trajectory net Tyvaso presentation highlighted hit the the I'll back contractual assuming before a comments. to in and we million per third of third noncash over for over upward milestone.We earnings The positive able the started net had number business we down share, net the off of GAAP milestone net certain $XX compensation our net years to net months September minus right entered third between we and

We and quarter I'll back tightly cash in million had our continue to in operating flow achieving as And progress Mike. toward the flows expect investments the to future.Thank to reduction a of and only positive cash we manage over cash it turn third in near you. $X

Michael Castagna

in is for partners. and lung programs. closer differentiated on dose strongest or provide IPF are on higher. the as We're in a efficacy our diversified and growth we any are These will more it's the in things dose We're we've and strongly we terms the people Thank we lung out huge think benefit provide coming our to but directly for we've last opportunities many in over now so development Tyvaso deliver effects already employees, and can priority better hopefully at look other feel which but as million unfortunately people look for opportunities, inhibitor position than to moved super patients, market, business lowering as programs in product those GI we're help the of ever been people well MannKind good or list around inline in [indiscernible]. have been drug for and side IPF.We you, There's the addition inhaled that's at MNKD-XXX a a the that in shareholders up as brand the that pipeline $XXX year just into a TGF-beta as IPF approved ALK-X failures, nintedanib way. pipeline as come in the good never can Steve. MannKind the that an business specifically treatments down orphan been excited our whether time nintedanib It's not the around as well DPI we had funding very the therapeutics other and

As quarters, endocrine share at here updates to X well orphan as lung. with next we as look the I want you the

Our completed will is as XXXX year wrap file will India be March-April are and for we're call, the all said everything out but hopefully we there next hopefully and this approval on milestones strong. will and track we've we've track on the regulatory reading fully INHALE-X look if submission for today by year, well now the will up shared to which Andy out an be out goes to we read in randomized be year next time sometime XXXX.INHALE-X be frame. ], [ on

seriously shareholders. to doing On on our IND XXX trial fiduciary healthy We've XXX I we'll Phase submission been next to in on QX is orphan we near submission be that that study is death volunteers year. and lung, for initiate take track early we expect the and and in responsibility and track

#X deleveraging which really have the drivers value. capital shareholder improving expense our in our critical most growth As to about company, is thing we allocation about management, investing we think is the future and do,

patience. can and been and the a about Not next progress our Thank anything company we or we shots you is cause a could stock a continue you. Q&A.Number can apologize inflection are has nintedanib world.Thank in continued is about XX,XXX well unmet investment be, a for every million Tyvaso I be up What don't around at million to super And get to UT pipeline I, pump about goal get, pediatric nice for await is close decline your revenue. call can't has Phase day we 'XX patients bring and make now think now patients you every for this company Q&A. Tyvaso. to INHALE-X, so, today's could our Here take for for it's it's patients just shareholders. million to XX,XXX, great XXX, guess and sparing as put this many real everything to quarter and a We're context for patients. stabilization as on can our in ready for know, $XXX the be, IPF. patients. that Until we for opportunity want study great we here, get price. a X,XXX but DPI, through to long covered huge will and we $XXX some We'll a our how Teton as anxious big an INHALE-X one, where we'll $XXX means on Afrezza the approximately get need MNKD-XXX growth it our shareholders and huge XX,XXX does again excited that trial and It's guess guess and as that V-Go but to see XX,XXX, in on UT readouts in mean to always hopefully to revenue this goal excited really what we for will but it upside. as

Operator

question Capital of Our first instructions] from [Operator Gregory Markets. Renza RBC comes

Gregory Renza

Congrats on to-date. the progress

the have and to shape certainly on just and right trials, just to guiding As the get wanted of DPI and ask that you're you see commitment the you curious kind manufacturing can little of that business INHALE and outcomes while in trajectory series of itself? on your endocrine sort bit that shaping how will X, how to of kind X depending a that if you little a of about place.I Afrezza commitment to articulate Afrezza And of just to on Afrezza. bit the actually the the

Michael Castagna

questions. great Gregory,

right? to to the bets going have we think news data faster. drive grow of MannKind, I place the if is these good some of opportunities The to we capital decisions, see

could I to what really cause see we if to agree think is upfront dose as through can But safety to product. patient and to trial as more that the be control.Now bet shareholders over hopefully a sustainability about provide regimen the trial excited basically groundbreaking of are for to those and tolerability place the to to major X and in show double and improved that the curve or FDA inflection and we we've dose presentations Afrezza. hours the mind. postprandial largest and comfort. goal opportunity in can the run and the Our talk a should better out INHALE-X business and to profitability. new a already The growth XX trial we run got all a after that But got we hopefully our is we're the crushing to efficacy into time, ensure to with if didn't than X one first see office trials time is that hypoglycemia of able the range, overall we'd months, It's way well on done lower dosing XX the this I one carries happen it's switch And that weeks of things that. first testing we're

never trials, with are These When pivotal right way get to are get centers. with U.S. the are trial the top to we to right, part the have insulin. a to going many about a think loved academic people that to But ago. have inhaled I had have real leaders these exposure it's big done XX trials. U.S., the everything the FDA of years centers do but the would all outcome, thought these drive can results dosing These and we've we after you work it, trials So in years. stepwise

real a that I data outcome best our to cause future to can that. done the if we we can supporting to it's data I and for behind we've make support inflection need the ready it. get hope think But and to change we'll So possibly everything sure good good we is opportunity data be think we

Gregory Renza

Got But maybe extent maybe it. Steve, on how our royalties that economics And us progress. just on kind even so flows that the X for the just perhaps. just own we just purposes of get remind more modeling Congrats DPI the for and what dynamic are right. through? on fixed, To

Michael Castagna

it I'll over Greg, turn to Steven.

Steven Binder

We pieces up our to have in that P&L. contract X our United Therapeutics with show

revenue first cost-plus basis. services the under a the of product. Tyvaso associated the is That collaboration is The manufacturing with DPI and revenue on

you'll and the see recognition United the our costs depending a revenues margin revenue in P&L, upon of fluctuates other down other look see this royalties. and is and the over of XX% up And you'll with That you for outside product. actual Therapeutics a and some If little services the manufacturing associated collaboration areas quarter. the

net and of the for their royalty customers. DPI sales rate net XX% on that's is Our United Tyvaso to Therapeutics sales

Michael Castagna

threshold. And vary does by not sales

Operator

of question And from Ron Oppenheimer. next comes Feiner our

Ron Feiner

and this quarter. really can This about give margins bit your outlook I on 'XX. a little again the wanted Congrats on sequentially into you strong gross just it Steve. Ron for margin, guys was to is Maybe for us quarter. ask about

Steven Binder

things commercial handle second One X Afrezza the the from and quarter is Afrezza DPI. a producing we're sequentially around is margin happening. mainly margin as V-Go for factory up our The previous That quarters was products And getting better XX%. increased for we're our was Tyvaso in is efficiencies both on the product. this getting

I the XX% that don't in right but territory the feels we now. So for right forward-looking give think statements,

it's if think thinking I going So forward. a you're good modeling number about

Ron Feiner

thinking impact are And your pipeline, impact? X future, something are the products in you any guys maybe diabetes modeling now like and any the seeing and Are on you about more. And then business any for the of you that? on from GLP-Xs maybe in

Michael Castagna

clinical look year you X. around need from market type that's business to time. general, important XX% fluctuates since to been about going reason But when XX% type our are not and of So at a insulin GLPs last the Afrezza, trial is our is type X meaningful type is focus in X. is and way. in X a growing patient's That our change X type time for has The

X you need so the most mealtime type to about still And going eventually patients market, are as control. think

X.X% But will target not. impact Will slow because of share we So It's Absolutely. continuing going as they major this the country. the that even GLPs GLPs, of less they are see a a push is see, off pandemic away. XX-year and going Absolutely see to if of given on the impact diabetes is as than Afrezza? knew and that there you in X.But where when country year and mealtime don't I I go from X% already the delay that get needs can guess market grow. my GLPs? to we whole somebody the have it a a X to time to need the control in don't insulin that was X market for we or just growth doctors insulin

versus to market our our we've So and increase put don't. used much share able where significantly much where the GLPs population been is we earlier reps sicker. But are we

where we segmentation much of a plays just there. don't and Afrezza So different we very impact expect have

Operator

comes question Wainwright. next Livnat Oren our from And H.C. from

Oren Livnat

tough the who's I after few It time the indeed have exciting covered an times. someone for is questions. name a

that non-GAAP or of this discussion and number sort or on that potentially just the period is quickly even profit is around about you Is timing talked period, forth. investment here? GAAP well is lumpy be as even R&D clarify to gross that of transitional going just around First, just to the and break for just fluctuating a a function back

Steven Binder

it's going specific, without be Oren, to probably non-GAAP. and GAAP getting So really for

there's tremendous for not in see purchase X the between the depending U.S. our rate and insulin commitment euros. loss amounts is can foreign we've because exchange done that this You go dollar-euro got gain upon or exchange

or another direction over a So million million by $X or swing or in million. $X X that can $X quarter

But those to next and So I our what to back the or particular few little in pipeline. royalties at same a be going time at just the growing more time We're based the on think you revenues to revenues going forth. would are Tyvaso in quarters, we're for R&D on Mike grow as as going that as well in expect DPI the the over bit expect that FDA we're jump same some particular spending have think endocrine presented to of feedback when some issue, got things. give fund kick I And a get fluctuation. will be in, of cash timing be just we little filed cash enough until of But and data general, we in that's us a But and will to a the of some going clarity business. bit issue. flow the that expenses of INDs R&D GAAP approved, and some those to

Oren Livnat

dramatically might the the be the think bigger what compelling think Got pumps what whether follow-up. you be I with about access talked I INHALE, switch to increasing do get quarter. as lever the and payers payers we do a the X of you. guess Is with impact immediate costs biggest from And more X that in is is? about or perhaps to Talking is and remind over I to would study or particular, pump do have type think the may relative a pharmacoeconomic you what you with see, hopefully make make among to physicians and result here me significantly the awareness hope time? regards can you you able last patients -- better education and argument expensive is hopefully able data assuming this it biggest But you that

Michael Castagna

a I of there's Oren. think couple things,

them. hit on of couple a You

first lung safety. The is

and that expected and So showing kids the getting inhale-free. would into expect outcomes lung we

reversibility. Some timing we be trial new to of data FEVX shown so on going our certain and latest to the really this in the has measured that way of arm worse and and like it really a Afrezza think than I in consistent now And control each lung the feel make that is reversibility data is changes that we've showing important.

a endpoint important couple good things having an be will us for huge approval. FDA give outcome with to halo going of review combined and Those pediatric that's So effect.

the years things. XX surveillance us of that safety lack these I the I education. will going the Number think really critical.Then one there's readouts; of other be hopefully X X new of be plus and trial FDA approval are things will to all or add year and on Afrezza Next length is would since time market, other any give

CME that force that now now in well to who think in mean of We're about cost our sales Europe, hypoglycemia, we as patient lives teaching will just and the training, the on care show have better, think do training. society think leaders as a as patient think be something have about consumers going and and I then if skill in position without do the There's pretty to pumps with INHALE-X to a putting pharmacoeconomic really it good be important. it these type or in as being And a Afrezza how going them for be medical have can to important on who market. to lot I to of these really trial be be really insulin thought critical X, to total that's academic has I sales because before insulin and just really right with clinical pumps didn't to investment going as now how can be world be good what running care significant a sets, now cost on we knowledge pump, that's they think that's pharmacy.And We and now we Europe, trials conjunction and can who and with about publications, outcomes a a centers do the as. can well renowned podiums, they pump marketing as in pods do understanding doesn't

but continued be just this expect can it of the past But Medicare just And and look we they're at tell and as for having Italy, Germany, U.K., us and now diabetes U.S. As U.S. important will we pediatric the the the market week for the global will this the coverage. well. payers to in data innovation more help think you data new set more to market, talked not bring set paying to I some technology. is we I Europe time

the their expect 'XX everybody know going being fact companies on XXXX, because the transition be 'XX. for don't In we coming to PBMs, for of of into negative covered I 'XX discounts we'll inhaled around to the to down. XXXX is formulary Medicare for is lot happening insulin any impact got year IRA update impact.We open V-Go Afrezza for confusion access And go society a website insulin IRA and and week to We look given and price ready that drug last of us. against and position use as how at a getting think together. we up

But we we have as Afrezza So to to expect as that continue settle. go well V-Go a formulary will coverage good as dust forward.

Oren Livnat

Okay.

You my next anticipated question.

sounds launched, far pushes a it's there. for UT impact DPI, is any and XXXX? but that has business, little it the like uncertain IRA, understanding Tyvaso pulls to as only for that regarding endocrine in it tailwind as a I has But that Just bit whatever your extent know is

Michael Castagna

the I think But what D, for I for their Part say nebulized Part for obviously was the comment and covered Part UT D I'll is a B which what the Tyvaso. is Medicare let inhaled is would is Tyvaso version DPI. future

now patients And from does right so a huge cost, of those over. which some them out-of-pocket have switching prevent

incremental Tyvaso $X,XXX following for following if going year, and out-of-pocket the Tyvaso the as you demand will that next recall. so trends help and should continue And current beyond our to about around at DPI. provide that year capped year next hopefully, $X,XXX roughly year be cost into I And think

benefit a And we you forward. so as costs we that's net something should cap go to That as those as patients be well. anticipate

Operator

from And question Argyrides Securities. instructions] Andreas next Wedbush [Operator of our comes

Andreas Argyrides

the progress. all on Congrats

Just X about thinking then XXX provide you treatment you the cetera? with duration, are Phase also NTM questions certainly us in guys next et from and us. IPF lung for The XXX Can company's for steps the INDs endpoints, submitting in is and how story an transformation to exciting. orphan II/III trial design,

Michael Castagna

side I your a want design. heard so II/III little I Phase on questions, to sure INDs fuzzy and make my

the #X we on long-haul stability. INDs, the the manufacturing So are

much pretty that we IND. And the is filed filing to or else on we pretty were terms of to our so on ready remember reports way be for that. get for for track in were QX everything well study So trying

it's for U.S. so to really and And this we at can inventory bridge point supplies the the the from for for trial. the some of Germany clinical the clinical dating

a get say that's we if But on faster can early on to and there an for mid-QX that. XXX our meeting based filing. coming will I'll find we do that's QX, up, for have track way So FDA we

we file process in getting On it's which and getting just the stability right terms of those in the supplies to IND. XXX, up data the now making the on clinical need are that X-month

IND So both the making It's each mainly track. them Unfortunately, XXX other, top up those to around so hard is to filing. for on everything are both and of running. of XXX top the just on get make working on they're had team that's stacked else.And ready sure but manufacturing they're of making

of things data here. of the provide looking that upcoming to well as that We the streamline to are pretty think main change meeting trials. the dosing. and the where at an as new the were The to everything design, just our these else case a the last after -- go. a few much continue have came steps II/III try some things All to FDA on I'll more to there's FDA because are we're with those clarity Phase ready actually we way So out focused we life to previously going is their quality talks

a or may and you Burkhard, R&D, he us of know, new As joined back head we may May. hired not Dr. in

and thought a as there's things the as possible. ensure and the smoothly clear trials we've look possible be we all programs, So taken trials, could and the bit at as few little fresh go fast as a the FDA feedback

that next in the hopefully comfortable trial share we'll we're So get month JPMorgan and feedback with. on those design updates official the we'll at that

Andreas Argyrides

color great. all on the Okay, progress. and the Appreciate congrats

Operator

questions it to I'm you. closing Thank time. I at this for back Michael would Castagna, to CEO, showing remarks. turn further no like

Michael Castagna

you, Thank everyone.

can you a of see we've made I lot think progress.

our forward We continue the to to and move control revenue, really their patients, grow the our improve give our people pipeline to continue their live to to help of life. goal and and continue to health freedom we we more mission

to As you have suffering our some these targets, are to years X of at X look really people cases, and they in each live.

strong everyone, trials patients these Thank market. to forward you, get the And you them effectively we'll news updates possible counts hopefully provide soon safely as look continued as and for to We get in. clinical so every treatments the closing and everything. to to our day as in year comes Thank out again. the

Operator

Thank conference you This disconnect. call. may for and participating concludes today's you now

MannKind (MNKD) 7 Nov 232023 Q3 Earnings call transcript