Earnings call transcript Q3 2022

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Operator

Good morning. And welcome to the MannKind Corporation Third Quarter 2022 Earnings Call.

As a reminder, this call is being recorded on November 8, 2022, and will be available for playback on the MannKind Corporation Web site shortly after the conclusion of this call until November 22, 2022. This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ materially from the stated expectations.

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

Joining us Executive Castagna; Chief and are Officer, Binder. Officer, Steven Michael Financial from today MannKind Chief

the like Mr. over Castagna. Please would now conference I go to turn to ahead.

Michael Castagna

I me okay. Good hear afternoon. could It’s hope Michael you Castagna, and

morning, I the and today. make Okay. you We're sure to got having started. me hear Today the want us Good technical joining MannKind. everybody before thank call for for beginning issues, could earnings new just our of marks

When can start see four look of to never shape product company. is down, revenue You single [sources] We've you growth to XX% and starting growth business see up now. to at been lung more from as our quarter-over-quarter. look you a sustainable collaboration really about Orphan growth execution you a excited and our than the with as Tyvaso, doing well in service lung, positioned also and XXXX. DPI capacity with XX% the digit growth look When The double starting Afrezza patients forward significantly at with was as quarter-over-quarter forward. enter well you about revenue growing hopefully orphan V-Go business at we revenue. endocrine I'll go we're talk and clofazimine Tyvaso moving to future

quarter-over-quarter. that in changes to minute month some integrated those month, V-Go and we a started we started and -- changes growing as market EBU’s grow made Our -- you'll but share place, in see QX year-over-year to over took started our as we make

get the is the quarter no. beginning. of is answer first just this our full Tyvaso the questions manufacturing, commercial first and In one you'll is the This manufacturing, see of is, I side,

million, The first UT, what we’d about by expected. commercialized royalties is $X our full higher were significantly which than earned quarter

in prolongation, were in have September generally TRx, reported focused FDA Phase later. X XX% our X% year about to currently On hit progressing our [Technical ongoing that grew to with INHALE-X, expansion product meet this year-over-year Danbury. quickly significant Afrezza paid results QX our by next QX. to on to mid with milligrams, adverse we're up and late program here place on capacity very to months XX Our on get track or planning Difficulty] is the We're really no expectation which On to excited On enrollment results and and patients. goals this QX. this QT well in six an complete and tolerated enrollment pipeline, we're year we here events for to

We with also our we to the pump and of results pump Afrezza switch will patients Basal is on the we maintained pump. the combination and an people ABC be which some a off shortly very we add trial where Afrezza presenting

On plan. and ready feel from growth. we've five our the V-Go fund year for on side, cash the good our we're Overall, we that stabilized $XXX growth to the have in million revenue we

devices see time but very Here's in product dry making XX/X It’s just also the at devices through [Indiscernible] working people a exciting and team our quick and not to cartridges. future. MannKind powder our Danbury just for

the really of solutions become we With mealtime the V-Go, purchase company. do

a doing pivoted analog as this start Afrezza We to talking well to as ultra-acting of me what to there. year [URAI]. share about and subset grow Let by we're insulin, on of off market doctors kind continue focus

and that a be excited quarter-over-quarter, our to QX, they're share decline and choice. that market year-over-year, QX reaching and we quarter-over-quarter, amongst the our so very refocus after watching to Afrezza years with of if And are a from TRx competition look new to the market growth TRxs, that growth targets should take we you share the this and how key [insulin] ultra And XX% year-over-year continued to acting insulin year-over-year. faster and to grow to continue continued from where believe see can of that’s indicator for us, share market grow we've growth NRx you fastest away Whe that translates look really [Rxs] QX, year, of leading month-over-month. had you NRx our

We see On here that's of the we're exit we planning TRxs X,XXX $X.X as for gave here million this expectations to [Indiscernible] with months and distributors, [Indiscernible] going year. [Indiscernible] as in additional and well in and Symphony asset accounts. as $XX been year purchased the that exited sales XXXX. XX QX positive next the force this happening of be TRx V-Go, a here a week. We’ve sales QX, around of XX TRICARE January of higher were we the some will reps in guidance over to in V-Go position this [Afrezza] V-Go continue additional PX million stabilized revenue we decline of we $XX QX into million business on with to implement into and momentum end

So to people research Afrezza ask results just that continue to to and telling fix the market the segmentation? on product ABC got where growth. for us accelerate We does what me and mean we need

providers on that to V-Go X,XXX both around the is narrow Afrezza, group providers. expect We on focus focus on write a which XXXX a set and of

to make win really choose to to we cash business this we play. breakeven choose Additionally, and want where flow

one continue you'll side, Afrezza focus. population endocrinology to and see insured the us the focus more On younger commercially on type

MPPA, bottom two core patients side on to Afrezza V-Go PCP. PX typically the our basal force. in in sales to continue All and ways focus their a V-Go and you position insulin two target force for for The be and population right be deliver that type simple target will target two will the for and control. PX type looking On be Medicare corner sales shows will ENDO, a

to MannKind. Tyvaso on excited As go endocrine about the about have going today, very future as our unit, I'll is talk of of we the business the well pipeline, we're forward, the end as impact

I'm going Thank to to Steve. turn it you. over

Steven Binder

quarter This our XX-Q, pleased financial which I'm Please third morning. and the this year-to-date with results. in select contained this first condemn statements activity V-Go good Tyvaso Tyvaso and four and the our and sales Afrezza by financial and is across review for call of our filed business, all DPI consolidated MD&A revenue for revenue, manufacturing royalties commercial supplement is the SEC lung September DPI reading to and full of Mike endocrine quarter Thanks, morning. business. orphan sources

percentage year-on-year, source quarter revenue, $XX.X where of increase focus revenue down Breaking revenues, quarter at business the shows which for table, the how bottom of the million amounted XX% Lower growth our net our XXXX. has have recurring including been $X ago hit of growing mainly as in Year-to-date, Looking third was please channel channel $XX.X had adversely million Afrezza channel seen it we since a million approximately to is revenue on by the third impacted due higher inventory which total inventory million $X.X in increase XXXX. and higher demand more growth this driven ordering by rate patterns, cartridge have -- was growth this came price, minimum gross XXXX, XXXX, a in versus wholesale a net of of with Afrezza favorable a gross The and have levels year price net channel including favorable at lower which inventories which paid TRx favorable a a much the was a resulted balances of XX%, demand net September maintenance that quarter product more patient their in shouldn't partially almost month third lower to levels the September and $X.X inventory million XX%, offset XX%. for mainly by theme levels year. inventory XX, XXth likely in Afrezza lower we period more growth six and We year revenue plus believe our percentage, ended favorable more. the mix. by

net in third where the had insulin for year-to-date, our acquired recently revenue and is June months for September. the million delivery wearable which net of Next represents $X.X million four revenue we $X.X quarter the V-Go, through device for

We XX end revenue mid $XX post $XX range. to of net the of the and range tracking be high we in to to are acquisition the that million million expect to V-Go months for

services. half Tyvaso from versus million third million to 'XX United manufacturing Therapeutics collaboration in XXXX. of DPI prior Included the amortization The Tyvaso revenue milestone revenues amortization XXXX XXXX for million million Revenue UT’s in The year-to-date of of revenue $XX.X revenue is of and collaboration and main the start driver $XX.X because 'XX, $XX.X million DPI commercial third first XXXX $X.X quarter the was of the for $XX.X XXXX. the in milestones in the manufacturing associated delay deferral collaboration of shifted revenue. has manufacturing. number the in to of Moving September mainly quarter lower versus revenue year services of with is

associated 'XX through which be Therapeutics. XXXX, we in the In related which of United the with addition revenue will the Therapeutics, with XX, agreement XXXX, the $XX.X UT recognized of sheet on income to September United deferred revenue term commercial to supply had remaining million balance is recognized

recorded And customers. royalties DPI we by to on of their United sales Therapeutics lastly, Tyvaso

United first was The earnings be supply digit we third next around royalties earnings $X.X the MannKind enthusiasm manufacture on that of full UT. a to by is sales quarter-to-quarter continue to on week call Tyvaso release for of million extremely a basis and those slide shows quarter royalty. last the earned a commercial we consider our The DPI said double growth third on growth Therapeutics sales XXXX. and quarter new physician DPI low and to for their quarter Tyvaso story. in high, engagement XX/X UT, based revenue and I

million second total first a $XX.X quarter and quarter, to the XX% then the a increase. $XX million increase the from in quarter million from $XX.X revenues second left we Moving the the grew revenues grew to to in in XX% million total from $XX.X right, third quarter, the in

Xx of of sales Tyvaso three Driving royalties revenue quarterly about are growth revenue, grew Our streams. associated the new future to with almost four Tyvaso revenue potential quarter DPI all V-Go. sources sales manufacturing the We're and across third the DPI from of first revenues revenue pumped quarter. growth pretty revenue,

and of higher excess a in our insulin margin to with of gross a V-Go. sold costs in at XX% due by mainly due goods driven quarter. profitability million decrease million in third timing from Afrezza we of be in Afrezza to profitability expected XX% gross some increase September due which table capacity the to XXXX year-to-date, XXXX. coupled spin the Afrezza the $X look in are of to third where at costs. and $XX.X maximum between September note and due amendment in XX% manufacturing quarter cost of third is let's and variability $X.X Afrezza looking incurred sales million at Afrezza endocrine of in the of quarter margin decrease fee margin and be. Please to products, of in decrease in 'XX, the XX activity associated quarter V-Go sold increased production goods capacity. The excess not increase margin increased we the capacity cost about was mainly agreement The as of that Now of in to second far supply When quarter Afrezza to gross profit shows always the there gross margin quarters for with of on sales the margin XX%, the year-to-date a gross right lower manufacturing an the profit 'XX will our and the manufacturing versus gross gross

million the Afrezza all some our and third revenue able to comments and We investments. four ended cash, and we’re me cash our commercial in conclude with behind equivalents growth pipeline strategically with Let $XXX across around final quarter and streams, V-Go. behind with liquidity And invest performance.

the company Tyvaso launch collaboration DPI and a like a strong feel the Our to turned start. off is corner. with is I UT tight has

maximizing on the focused our of with collaboration are We UT. potential

on innovative focused growing emerging you. turn bringing back pipeline our business to our from key products a And milestones focused over endocrine to we are update. patients We are provide it review I'll now profitably pipeline. to and Mike Thank on and developing to

Michael Castagna

summary. Great Great Steve. you, Thank future.

on things XX that going at look couple are good you share purview just over where the with the and were we endocrine I'm to business unit next If months, Afrezza. a

objections low major a bill around was a the get want for pay fully available. $XX that under that ready we First, program quick will In be it's program inflation act patients passed. at in for [house] Medicare next the to as XXXX, want changes not to covered quickly QX our really started to That while see year business. here we patients to cost cash to game protection that you the in of can access, pilot is Afrezza Afrezza only as short we Afrezza one I expect start and $XX for scale get that

could] latest. [CGM] that launch going our to goes we full thought over and year, study the addition finally on in a pipeline. to or readout I'm next very type if was to as we're happen study, of business. team nontuberculous formulation going our giving QX year one weeks. getting that [Indiscernible] integrated it of which almost and the And and Tyvaso to working that in and go With we progressing we a terms focus QX to This as orphan QX as to to the by and was we lung at best position well ready we On patient patient well. decided this the to as started years submission into give is study. orphan we launch happen we're be to lung on our in late INHALE-X lives are patients. soon to MannKind report are look the in are there. Hearing XXX, three ago readout we hard help ehnahcne when ready pivot as nintedanib, study that's at on couple in fundamentally we’ll enrolled technology to hopefully, expect fully the early [Indiscernible] In extend X, opportunity our it engaged DPI next beta, XXXX, a using FDA their clofazimine, with X. that Phase is to them QX [repeat bring then X is for stage BluHale in a [Indiscernible], life. scale On with pilot TGF We that next next two QX final product mycobacteria, but and the freedom fully shortly rapidly live stories the our the Phase comes people’s heartbreaking, expect

One recent their talking On the on after. to our start they're the and the how space. [Indiscernible] cannabinoid yesterday understand of program, progress with data though the the do going thing forward to continue opportunity pipeline [Indiscernible] going on and we released help some trial, people we [Indiscernible] that was that and just watch oncology second to we're

as to pulmonary hard in the diagnose, the well this hard tough severe to consistent drugs to this Competition think a line $X is US We generic much Japan summary. unmet and are the at with NTM, very big very called the narrow our orphan I treatment, market a failures In of idiopathic is this market this it's look because is another you XX,XXX with is good here littered to billion fibrosis opportunity. of in look pretty very patient it's When most in have as the patients disease, need, large billion for range. market is very toxicities. space, and get hard $X value for a population. it's treat, as IPF at about XX,XXX

approved believe orphan delivered who options. related nintedanib the give side know do IPF and an lung of excited the us about as reformulate nintedanib dose where is cannot We're at limiting in much we However, nintedanib the of an patients this higher. one event, XXX,XXX pirfenidone adverse we there's only more opportunity need to product effects two they rate products

hearing and weekend, and and in be at who this life subset infections. extended continue I the was On population. to fibrosis of exacerbations of who there’s side, patient actually privileged CF that’s been all past subset expectancy a a have patients to be Conference the expectancy life extension, progress great Despite the to sick continue there's cystic the this patients

the the great are drug develop in are you to sputum, of patients go they longer are infections, to can't getting the These community In as unmet if better you we conversations space, infection I has an forward. fact that no CF product do the Foundation are was need challenges interest sputum. to how think the the people's these pipeline and so producing masking in that in and and point because fact, opportunities lungs there one our treat the the CF culture continue

MannKind the has we’re have and results, XXXX. QX, we in our released all the out we QX here [short]. [Indiscernible] up XXX the all track for year out is quarter, good year a strong been also them. of Nothing [XXX] hit on we every [ABC] lay get to feel there and to and close ready that we're for lined pretty stop great of get ready and I'll As milestones, surprise questions.

Operator

And comes question Instructions] Folkes first Fitzgerald. from [Operator with Brandon our Cantor

Brandon Folkes

just Maybe two me. from

But how have had give with the running of the just Tyvaso the been of there, we've And the DPI in of ability you talked you have this Tyvaso Can update about on challenges then maybe board You on staffing? continue? up point to terms you staff do an manufacturing just across us XXXX. clarification. do in XX/X. should kind staffing ramp a strong you sort ramp have of Obviously,

I V-Go. think additional going to that these going have company? hires to are current Are sales reps or mentioned you to are detail these they're the Afrezza, target, that you XX risks new detailing

Michael Castagna

answer business, one the of We existing add it's we to our to ton that diabetes to existing more a V-Go have. easily, Just infrastructure infrastructure. leverage [Indiscernible] but infrastructure the bought

current the across V-Go dropping country that be sales So people January. Afrezza and we'll bag in have we around XX late

clarifies hopefully one. that that So

more gets real On that's continued XX/X relatively XX/X, staffing, starts of the the thing and production, when headaches, efficient issue equipments equipment when have really turnover the when that's is stops, it we've on the we on the low Tyvaso fortunately, had manufacturing, very over think, I time. the And market. to ramp actually year is, a running biggest good ramp,

to that's we rate need as the you up the ramp the and is fill terms cartridges on and is that at packaging continues sure ultimately think focused where on chain so team the then to the production get better pharmacies. equipment making manufacture, And of supply shipping in I really

more in the require be by don't hire we're outside the some scale building anticipate a next to production, facility near which that So people major have Danbury UT. reimbursed extra we will of in and expansion up year, will facility. term for Remember, employees

with XXXX. demand have will that an sure to and in able supply anticipate to we demand we currently, we're upside already So worked make UT

Brandon Folkes

Do you in. mind I one sneak more if just

But forward, to strong your balance in the given you then you mentioned about getting company you've I of for just sort given And capital Just me. investors going think of strong pipeline. know position your allocation that's cash about do balance, talked your you understand sort on the how it sheet bought now?

Michael Castagna

And I of our future with priorities board for year question week just think that's the five the last a company, the we around had plan, investment.

look way of in has there. the a budgets also company leash on continuing business a think I will for tight we amount opportunity. And the pipeline and of is external think the returns that we huge diabetes look at we're for terms money to spending the We run innovation.

on decided give the as let's uptake go of we pediatrics, Afrezza drive, believe that a Afrezza We off believe the XXXX, in really we of we in invest let's that do start. us for great milestones do to those XXXX, priority there's data, get in haven't and information the which put will some in but some focuses be We should of data unit will more invest forward we V-Go 'XX. that business should harder some

a we'll as believe V-Go to We start also platform. see

ready And that as for I other to of get that products. it's for next device that's can you platform how probably something diabetes. leveraged year, some be go, repurpose we we a talk of is do I now, but think where think that's can about outside capital V-Go don't which want

an we're that's that area at. So looking

future the impact got we company. company, in down the their we is think get And efficiencies we the do bring our across the inflation, How automation? I then given on employees? cost investments the structure in more growth the And to out of have,

automation So one process to process. digital today in transfer future, is from of And decisions how manufacturing make the more bring and a on we’ll is for to invest there to automation ways the a efficiencies manual to around and data, lab example.

scale things don't Steve, forward. if I the company you that as comments like have go efficiencies continue that. bring as on we So to additional we know,

Steven Binder

Mike. good That’s Thank you.

Operator

And our Renza with Capital RBC next from question Markets. comes Gregory

Gregory Renza

is engagement some question just color you currently, on demand. piggyback touch comes on if to through that previous with And those I'm maybe demand meet be you've you and engaging perhaps there there to works? lock points intend do is and launched provide down points maybe say mentioned Any the just supply, I'm versus the previous collaboration when the that that it closeness the engagement curious Michael, highlights the development which direct, advancing provide change,care strong. color for which just that product on additional could to and meeting ongoing now the product that curious, just process? process or the healthy underway that runway you capacity. and can anticipating through how

Michael Castagna

the There's it product hopefully, fill fill-finish cartridges, that then we continue when there's and of one fill powder much in different produce the how limiting build spray you the can currently, two And as steps dry become does per per production process. and much comes we cartridge the one you year part things one that can cartridges. what cartridges [bring] to is efficiencies really can the of how to will be rate will is two [Indiscernible] that And that quickly will -- product how yield, on minute. second that be those next to production. online, Number lines and to minute, expect

side, part so other that's has flip The and dose patients But the UT also titrate they is ILD. patients expected. than the little naive up higher bit dosing, shifted more a on probably

XX unit than for much requires as times got units. of spectrums, So we cartridge, XX kind power of four those ends as both example, and

capacity we limitations launch good needed and see, to can term and the We stock production is the initial UT to that to prioritize in launch adjust the the week. we sure make we get feel The short continue news volume good are, we are of some there's the to that retain as with there's that and time no example, as those great no phase every things weekly, to when for to can where balance outs. patients continue collaboration, the adjust talk this packaging, volume, communication, can watch week about we that So most phase. drive packager, every this production we and

So, really so everything well. going is and tight far, very

On the the that, opposed companies to to you ordered out capacity effect side, these rate buying we hear construction equipment build really as And saw. from continue happening, see what is as there you other manufacturing, we to stuff is the days. the limit equipment, which is many

we where done the year, we when anticipated So about feel it of getting the and anticipated are high getting good from XXXX. factory, pretty expansion ILD we end next for built and PH. ready we we demand And

So where we the can see. today we supply from capacity that market have to enough production are we

that think questions the I answers there.

Operator

next Lichtman from our with comes And Steven question Oppenheimer.

Unidentified Analyst

seeing 'XX, a This on of easing shortages you What bit you’ve if you please XQ Lichtman. that BluHale? on you is update ask can chip the timing see remind Are opportunity in past? an you for give gave any Ron to -- for new I us can you the about for can more guys BluHale the talked a -- you and Steven if wanted just launch. about

Michael Castagna

make sure question I properly. to want I your heard

Tyvaso any and… I think asked on for shortages launch you

Unidentified Analyst

been are seeing shortages that, you BluHale. on we that from that easing other talked And with of with any shortages. update No, have And an the because easing issues up the some in launch heard companies of the past chip a bit. little because were you've

if you for well wondered that if about BluHale? you us can I as So and opportunities the affects remind

Michael Castagna

So that were so reprogram had we in chip our bluetooth term. short technology the and almost the We're that's main and in done motherboard all to BluHale or scale next wrapped was became should iteration large that. chips shortly. using up obsolete by the was, of we terms redo we The limited production, on around

the the not should patient us, in able rate the we'll power term should the patient that believe and make at QX shortage worry And short have QX consistency behind limiting and so launch, and we're device, least be our for factor, experience. feedback that in be shortage we reliability enough of much the that to be launch, coming about but units chip we

So working app team really we BluHale. the finalization through device feel just part an XXXX. most it's otherwise, But the looks [Indiscernible] for technical placement looks job. did like great, product of and patients. be I in be the should ready to and go think great, the aspects And critical looks The nice like going there. that's amazing We're it to it

Unidentified Analyst

us Just Could a about for follow-up you the see you opportunity guys BluHale? here. remind

Michael Castagna

think deeper go We technology I dosing continue to in opportunities one. we were there know as Opportunity, feedback type and important. are and loops

opportunity. so think is for that to that one win be readout, Yes, the with that's we control the type going And market sit do insulin, simple market. tried think with able faster that's study on we also [omnipod] V-Go, mindset. repositioning a for type we're well nice Afrezza think two that's twos, market is growth success in research for get more natural with new their two use really type for really we I CGM. segue And to get now them. to we do Afrezza type one. a best a sits think want to to being the really to used type right used we the think they insulin, crowded Afrezza, from time in we're Afrezza nice that type pay [omnipod] And with know really but device two. faster help it And dataset will default got in with model. And want one, type and place about as pumps they we'll where into go We really reinforce doctors into We the the long really able a have a is they [Indiscernible] dataset like positioned. They’ve already launch. the just by people seeing, the that feel and device [Indiscernible] you

for solution assets customers, had. co-positioning really feel So those is of good we which we the something and a providing always about really

Operator

from And our with Robert question Hazlett next BTIG. comes

Robert Hazlett

So me. one two from or

gross think is in V-Go, expansion that that and with on said XX% hear was product? margins and Love where was that margin opportunity Is to I First the there there. with in of for expectations. XX% an line what you for potential came gross

Michael Castagna

I term, the can when to met some the of think the you on we think to In allocation. the margin, of These make Manufacturing Head gross survival. with short investment, earlier always require focused any now pipeline. just think we yesterday. when profitability, going was we to because are are capital When We automation five there capital investments types view focused advancing just do Jeffrey, the were we focused that's [Indiscernible] things is. on we It's two but of have I now, are company, we in it on on are allocation. focused the year hard on a

be do be you're to to over will true and invest manufacturing. expect And look And is years can automation plans are to pediatrics product. gross DPI back paying at thing decision as also we years think And net. to these in off bring we come forward, Afrezza. to three to now. next and the same here, V-Go you fruition. to is the continue gross last about based We're how we to made when I four So that in the risk through got Tyvaso make the the the Those the I they look think going margin decision right, now we we approved -- five made where decisions

the we restrictions, these value And to get 'XX payers go to all make and as attributes expect really terms get are access. those two the access we’re So profitable. patients to that products of important think help it understand to and easy are from we for [formulary] in continue going we we into getting more

Robert Hazlett

in And are see with to administration? what the of in data near going routes the are and have? future of anytime different any in And the results then I to the that just with program. to guess one what goals are could the pipeline for on on regard AEs the we you touch product the see terms AEs, clofazimine. it skin Is of maybe if you just publications steps next you reduce

Michael Castagna

first, publication night just a of I to reviewed journals. getting that's last the one Well, accepted

comments our going were bring So patients. unmet animal that's It's clofazimine that around the to data is first nebulization positive need really reviewer and exciting. to

aligned. publish I and The in of and light here clofazimine regulatory well will because a FDA, so complete there's in in Japan how a really function. with a sputum that in up report. doesn't Phase dose thinks NTM endpoints thought critical be QX. from we terms and forward form difference FDA the or December design we've the see with to the some give dosing. the it coming We'll that positive. big just us feedback mean be with And to that then I set any data fill X the data We've for between study FDA is the late that hope assets was the with X/X wise the will FDA the -- Phase mean range showing up are commonality we be going to effects out, green find to doesn't as But all meeting the and laid is And going that wrapping agree able it, should of what go conversion, to Japan think

you get both. and weeks. think types this But is hard to three happen it as And can results, doesn't takes clofazimine it very we to a while disease in two improved so those treat know to of

good. that And so feel we

as half dosed In that into I an terms because are be thing about of the we it improve is drug on underappreciated. long reducing accumulation one of clofazimine, you been the really lungs. toxicities, dosing And regimen want life, and our what think clofazimine that's will the we through to incredible think has number of the

effectiveness it, then want lungs foresee side that like discoloration, nailed don't the high deep they for clofazimine. without one I skin we the getting issue an issue. big that's a that's systemic and the a just the be far effects. complaints patients into in don't that And we a [above] dosing. of patients. going and But really very to the that concentration getting lastly, effect to any We known prolongation, expect you don't see that’s we QT [Indiscernible], think feel so give our side And

and dose. feel highest patients that really not seven about on good days, have after our given dosing profile yet our We that we safety seen

lung from be it's should administration. route site overall clofazimine a at think hard for I to that the product So and safer penetrate very better the infection really treat patients that oral

we see, that’s a So in we'll need patients. these the a and struggle unmet think big lot of

Operator

And question from comes our next Thomas SVB Smith with Securities.

Unidentified Analyst

quarter of of on thanks on the in any Tyvaso you'd potential This you'd dynamics really you're a On sense is if Tom, seasonality trying are some manufacturing here? preliminary get commercial trends taking expect quarter. to DPI, and And there kind congrats that investors, first provide you can for questions color seeing? a for on of and that for strong our XXXX, flag ramp Mike other the the

Michael Castagna

think think is think get watching I a investors direction. least one a that's has say, more bit, at okay I'll distribution But little to Symphony and I've some people thing I network. talked I to UT are don't very Mike, close data

those show all there. probably scripts not framework So the up out in

launch, can right, just only we launch. up this we trying sure is successful manufacturer their are product, this so their much, with UT’s and So make and their is we their revenue, demands the to keep say

job we week, doing communication. see any product a a anticipate and don't so we lot don't constant We're shipments the there. demand, problems team And every inventory, the looks -- of decent at really the any

and it's quickly. takes pretty and we look now, we packaged, And can about Things So we as of through days think I it make batch I can't big of to it’s the think time terms see. beyond by about [Indiscernible], we're week our of on happened chain demand, at get But supply have released it in top our we XX that adjust every always control, time. a get we it.

So we that quickly demand forecast. can pretty adjust on

I think a plus how a no-brainer freedom more it's question. you for were and you to continue is that XX% we that And a want thought we DPI and good to that And think obviously, getting, coming I going the pretty to DPI. becomes nebulizer, from for was feel heard billion fairly of UT, grow, which people know thought that product they're if XX% billion is patient about that be for were I patient's because referrals I the this was what statistic, very encouraging, in of going be to this. stories dollar heard going dollar good more that. is and much it's And

is I think you market. this around other question topic the I where the see do get

closes leg and the Part conversion. But XXXX, create patient month of feels the be that those think UT that the costs limitations out next XXX costs up. so would on is will about one in will good I the D, reasons there's news that's know of I a and some whole pocket capped Medicare roughly,

next have anyone that doesn't on months the will opportunity get to example, convert Medicare, that for that’s So there. XX in

is a die. are to going tough they want people die this and disease, So to don't

remaining mean, really for encouraged motivation positive. life their have, and wish extend been and patients our feels the changing really doctors for And and pipeline, is DPI because so feedback amazing those it have our shareholders their and they analysts lives. our of to And an happening, they could just stories I the more by Tyvaso extremely and and investors life. motivating changing are extending and much team that doing is want lives enhance life the so the job years hear that's our just I our the

just here. super it's exciting times So

Unidentified Analyst

respect And a one then Afrezza. to separate just from me, with

of job a think clinical coming out leg in could particular, the growth there. that or there you of a for Is that seeing kind nice that did be kind laying milestones up certain important you regulatory, sales? either really a have of You one, product important for next

Michael Castagna

an seem years go. year to a along. we And couple drive next Afrezza where COVID something growth and to I for then of Afrezza, is Every really to don't execution on just to spike to guessing think going it's keep to try is to I year do investors fair year. different hits try think and we

a to And foreseeable done for If million purchasing future, is year to a we XX% focus that's the for that's and business franchise to business just and execution for so year asset XX%, really what a in we going really and next million an V-Go, do the $XXX have good on have $XX MannKind. this alignment. growth, integrating

upside really a focused going as can one attributes good And as so those be about data many and are the real an opportunities. But change getting of show believe to and we're you think to profitable strategic to much the to helping type able and important, pediatrics this will we we will company, at we this some on. where for think bets, patients placing you're one continue time is as I of care, We them. being readout division are kids system hope the demonstrate where AID be is that being we as

to Afrezza really the the Those happen at we're those next looking milestones in aren't really going is going six does the months, be but that kids, saying, key do are in to game how on then opportunity focused I But less important think, be type changing but important we're India and India, transform in will important. growth readout little to Afrezza really for XXXX, [Indiscernible], ones. data to

got we market, we've you additional that'll type And X.X to twos. million in work live there one great But to one, people type really for know, support -- get to type a not bill, foundation awareness nice they’re and raising the insulin a the that out have is society, [Indiscernible] JDRF dataset twos, the lot and what the too think be half first kids that in still aware diabetes, opportunity in so studies there's India patients our more the to especially for many recognizing, with option. walks drug with type there's patient

little we ladder to have we out. the have by But plan year and on we’ll the map, and a good bit. we team up got move targeting. look choice is doctors eight things we're we a we in think they year, could Afrezza choice that it's And set, of get from number amongst the about at we're team I And just the here think out next making that we that the when a we have. got so we're to very about really not XXXX with year -- eight just we And do sure do I feel better like a

Operator

now to CEO, like remarks. Castagna, the turn back would closing to conference Michael for over I

Michael Castagna

are talent possibly really, could with got best We the Thank you, the monumental about Daniel. have. shape in super it's our been, the we really Tyvaso. future. quarter excited company, The feel best we Overall, company ever for is about we good where

the flow positive and to terms years. make will the by unit us business the continue Afrezza great and for cash end V-Go in five in XXXX of sure that endocrine change be is an focus, pivot next We year. a to make pivoting of

really assets to X, think going that's from XX for the X, on be progress monumental stage to the X, start investors a Phase to pipeline, months value. you're think and preclinical really in opportunity we to understand going formulation Phase see moving nice next I Phase of over the that

the lot when for of Just don't years, really have think look one signed XXXX, pipeline, I UT we like no appreciated have Tyvaso as pipeline. until XXXX. started value And think at the it this you or I in deal attributes we a progress a in XXXX. with we in probably

we that the where to future out think company. upside going I and of investors to start quarters. think ultimately positioning the the over for you're we And nice from come are see that's a couple next

we sure to it’s do just the going patients, and inventory great a It's helping stay ahead build can to UT make demand of we supply to of doing an -- just product And to what sure we amazing a make and and that we Tyvaso, is everything curve we lot do rock world. the in And continue will patients. job. can

positioned excited is great economy, feel about are. growth biotech double great for to year. Thank and So well investors. a future, very XXXX, for tough the we positioned year. have well tough you. digit we’re for investors a overall be But MannKind's where Company foreseeable we It's

Operator

concludes today's conference This participating. call. you. you for Thank Thank

disconnect. now may You

MannKind (MNKD) 8 Nov 222022 Q3 Earnings call transcript