Earnings call transcript Q1 2023

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Operator

Good afternoon. And welcome to the MannKind Corporation 2023 First Quarter Financial Results Earnings Call.

As a reminder this call is being recorded on May 9th 2023 and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call until May 23rd, 2023.

This call will contain forward-looking statements. Such forward-looking statements are subject to risk and uncertainty, which could cause actual results to differ materially from these stated expectations.

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

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

Michael Castagna

about people call is everyone mission you, a of afternoon. At and Hope our strong. versus undergoing freedom currently capacity of XXXX. of Patient We're and give ‘XX. Life Thank expansion, QX MannKind, collaboration manufacturing talk live later is to Humann. the which great demand our having control excited health has revenue that call. their life, quarter operator. More is XX% really in to UT driven what highlights of this is Number We're one, first we I'll royalty our growth

ahead Clofazimine in proceed. which successful written moving FDA XXX, pre-ID MannKind quickly very is on how on comments with meeting a Adaptive pipeline going Phase we and had Inhaled Our with we X/X, to into received

underlying with XX% XXXX, over Afrezza we Our is versus we growth endocrine traditional QX had the growing sequential decline the New Year. business and versus that business in strong see

standard throughout expect early bag growth Pump are QX and off in care, called going that in sales product hopefully continue in which next Sparing, starting beyond. And dropped our we against we and our late of quarter. rate kicking be and enrolling this we in quarter, health V-Go, QX, Afrezza to is the Additionally, be first trial large X that a phase to should head-to-head

I've in of had year, is and loss Can engine net From as a $XXX made year hand, end million decreased managing our six our last versus cash liquidity which a per last decrease the from demand. balance. the growth our we well. cash versus we're strong making patient on perspective, a continue share in see XX% only million the to by progress DPI

several this a the uptake place in there's UT asking. and that result, continue As drive things should put strong support is of demand to we've that quarter

by improved This drying spray our was we effect current sure a limiting one, bulk continued that to manufacturing supply in right terms process we we've we before doubling make rate our constraints. Number addressed capacity. increased demand hit any wanted of now

We June. expect be this to online in

the throughput and the as yield comes when and finish well. fill increasing we're Additionally, packaging to it

in inventory All by of this improvement our means supply second of ability half over an XXX% to in that see the we should XXXX.

Additionally, we XXXX. to as capacity revenue here for expectation, is we online in blister growth additional this will and a out building in in and expect QX the indication, expansion. strong From expansion This high capacity as saw QX. we bulk up spray be scale capacity cartridge be are fill IPF around patient done well drying volume possible that a

well be as expect for XXX to and patients, as of XX,XXX would between million, include should XXX collaboration royalties. annual MannKind We every revenue which services the million

in On look of our that copay we year endocrine this Medicare business, driving QX. impact happened January operationally $XX in as favorable at is Xst

selling beyond. direct grow we impact we business purchase QX growth in see at continue that, look lower and XX has channel. we sales as patients to Afrezza continue of to now our And cross-trained but and Afrezza orders V-Go our selling reps force been about about We have only. reps these our pharmacies as to and had both the than wholesale We specialty V-Go shift out and and XX

gap chain to by the be break-even of we communicated, end anticipate this previously As the business by we endocrine year.

next readout the the we're that will for publicly the here we to conference, what enhance the expecting in three momentarily a and into that referring know one, will seen XX XX we a patient trials trial we don't filing of we've if data of which trying Number we're Afrezza expected. have present future they we weeks. dropout half we data have XXXX. out the X I CIPLA than Phase scientific few at as but as least lower understanding announce we're next the INHALE-X, really to the is a months. India, and sites expect over over or Additionally, go data INHALE-X, at read to know for second

calling trial be which Standard will of Afrezza is done receive versus U.S. largest hence three, top we're KOLs Sparing, across INHALE-X, Pumps with sites. And XX adult we've the the This Care. to a tier Dexcom,

As our such as first a time GoodRx, indicator, leading made in that pay changes for which impacted we TRx. the we cash at Number coming We look years. one, pharmacy. could canceled into the card, grew V-Go, our administered two XXXX the at NRx be several is that

our end we've as NRx ended as go look card number sales force. impacted do And our $XX three, growth integrated we that copay cost at have see little goods we little we track into to so free can our we upped Number continued share being million. bit have patients But to All QX these three to on of from more would this high a forward two, our the forecast, combined we April, point TRxs. of the now in program. we Therefore, $XX forward. a in bit the meet indicator, leading see things we're that Afrezza

XXXX, look you on really NRx Afrezza, As at we growth. focused in accelerating

you in and the to for NRx, order faster XX% QX, continue grow growth of than see is what a can XX% again organization, and and see This NRx NRx to was was complete every major quarter, from growth, which shift TRxs a to we needed you QX. in top force. bottom improve on TRx, see see TRxs. we leading could to And focus as And happen you our indicator continuing here, QX is sales the it growth,

copay, the reimbursement of a So, our XX% been approval Medicare $XX seeing over we're through rates the lot QX hub. has where upside

As We've V-Go first half. already into out see first several and which key the force the we is in the half the bag, sales Afrezza half, the completed close second $XX. first we milestones Medicare and going two,

have we three kickoff. inhale Additionally,

We those expect our in our launch, Viz investigator is with visualization patients meetings off, month in our with the QX. integrate and BlueHale have CGM here have going about Dexcom QX, hopefully a should kick into QX, inhaler. to data In we which to

enrolled in year. we And and fully with enrolled fully out as with to the expect close we INHALE-X INHALE-X QX, be

going to I'm over Now to Steve. turn it

Steven Binder

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

growth revenues and totaled in grew extent, first associated XXXX, of Tyvaso quarter to United total $XX which is $XX a lesser of the collaboration of million. the royalties with our highlights and made quarter $XX first endocrine Our services revenue DPI revenue million XXXX, up our with business. which Therapeutics Revenues and, XXX% versus million collaboration from of

royalty manufacturing on product the manufacturing strong the later the times net sales revenue yet much was of our life. recorded and deferred not revenue of DPI patient for revenue double-digit in UT of earned a contract We $XX result the for in quarter, which over was million of first commercial year were services a Royalties ago. four recognition Tyvaso low collaboration and of and million We of demand rate. $XX a

by to patient revenue down endocrine in to a of $X paid higher net are a our driven XX%. TRx $XX demand rate $XX mainly Moving made higher with underlying revenue were $XX Afrezza and to growth revenues million, XX% million and at price, million growth up including of endocrine net million. XXXX, is Afrezza the year-over-year $XX of table favorable of business, growth million total net of adjustment. compares growth which more net revenue The V-Go

full-line reflecting Our growth from lower to wholesalers XX%, XX% shift to continuing using pharmacies fees. went a with using specialty net from

V-Go of revenue in end from million XX to revenue forecast for product our to purchased million, post-acquisition. achieve acquisition, comparison due was the to the period has high no months million V-Go It's was quarter Net million. the and XX first on second being XX totaled a of with the original $XX of track quarter of net XXXX, prior Since year XXXX. there for $X of

of shows of over Tyvaso revenues growth on V-Go, of basis the period quarter-by-quarter a the through we've this DPI first manufacture with The mix sales in from significantly changed The revenue second and next commercial the XXXX XXXX. quarter the source added as royalty DPI, and revenue of our quarter XXXX. has growth by all first starting slide associated quarter of revenue, from Tyvaso

in new cash, inflows versus time Tyvaso our grew Looking cash the Tyvaso shows strong our revenue, across the revenues associated but quarter the sources revenues. with and total have that the reflecting first of cash balance. not next XXXX also the in The had first growth DPI impact equivalents, XXX% quarter slide of investment of DPI-related XXXX, span, only

You can in our first the $X cash third of point the being investments quarter see of reduced with by with inflection single XXXX, mid-XXXX. digit, the in quarter-on-quarter only Starting quarter only a changed, happening XXXX million.

follow-on of of becoming move cash our our and a value. shareholder us tightly increasing endocrine cash believe which manage quickly started to adequately the and for while cash, positive. anticipated our our of our company business cash without profitability continue investments, lever Also need with cash that pipeline, level equivalents, to operating the flow increase any the investment outflows, and which inflows is Tyvaso We our business, note associated in towards have being We plus our development current invest next and offerings. in to revenues DPI we allow outflows from will benefiting and grow stock product that

revenues on has expenses, we haven't and path our we progress significantly spent share time reduced been to grow as finally, our past, profitability. much per but we the in as manage EPS down loss the our And

turn versus per of Mike. $X.XX in loss quarter first of Thank it share of quarter XXXX. $X.XX and you, the I'll share over to The per first loss now back a

Michael Castagna

Thank you, Steve.

pipeline marketed to products. a you very all see, our we As can in addition robust product have

ready Brazil and in back We to year. in to be to able expect next file hopefully early second relaunch the half get

just is the the well our really along patientcare As supportive half, we in model, [Indiscernible] as and second data as way we pipeline, into at to its dosing is received the in look forward ongoing. Clofazimine as moving quickly get nintedanib

in this humans this able year. We next late to be early product year, expect put to

beta the TGS progress months. as have next is we shareholders in the pipeline have over story continued get our the lot look we year. XX We always next. company DNA-XXXX from Part building we those what's we momentum of as progress updates value and our believe nicely, on at to don't we'll a of

you do of last studies the and small lot how have over five over pilot new studies work redoing at that These titrate the ago, We same around studies manage quickly decade are time. a the was up we've but is the off years. several basal basically done dosing done the on new insights Afrezza, which a and based

these results we're to in And the excited near see future.

On to to phase see assets organ over one, we as the here, continue rapidly. from you going the IND to progress months, XX side, this moving forward to several development have next and can one, submission phase very

As shareholder I create drivers perspective we bring wanted some value forward. how I you to out, on go value look as these key

the first The This we of enrollment. XX dose. should MannKind roughly expect is terms take trial XXX, dosing months pipeline. and in a

patients, $XXX expect approved, approximately X,XXX in we revenue. every once would For this is million

by we UT upside in should This pulmonary expect When XXX,XXX progressing you X every from into Tyvaso patients here in kids. revenue happen look somewhere the and last patients first at to collaboration endocrine phase has business, T-hub remind range revenue. is diabetes patient's the would with of that And disease XXXX to $XXX and and have dosed million these XXX, And study over that in pediatrics. U.S. for innovation between the orphan $XXX we alone has be royalties readout in XX half there. years, be forecasts. to we be of service for to idiopathic DPI a and continues rapidly our we fibrosis XX MannKind the an

XX, there's the and well data doing study and we what show as results, India diabetes. new kids' to a damage of be that Every be $XXX but delay children We manage really sparing their able we're that pump that start readout million upcoming additional that insulin lot skin or insulin that an in there is really to roughly time. are next not these to years. help and this top excited market pump delay pumps occur as the the good and XX opportunity can launch there, parents with at the about should share believe once do will it we XX% bad, over an We're revenue inhaled get of on using

place. a put growth we've stabilization V-Go, plan and in

this see fruits You're labor. of early the starting to

As with a things type type the devices people and the we do more insulin of one look is lot all delivery in rise X that should at we see market, X, time. coming in

our the So, thank conducted be at will internet will to talk you This reach dial more for annual this we annual seeing wanted will for shareholders that. four shareholder XX more and meeting three, times meeting. than to about why live shareholders via And we a.m. as be we a May are hence MannKind meeting, this had typically go we in live route. in XXth

proposals voting our point relations. future, Danbury, our on all eight For All those and to your see be shareholders investment proposals. website meeting reach instructions by that several were can in supporting this for to on joining that at need the some endorsed us are proxy, board of interested and out voted in information there the to be please and ISS found or

close letting next to know years that granted scheduled over want events out the past. in were two, just you are weeks, grants are RSU I several that there three

members multiple see set plans transactions cover leadership will Xs conducted under filed executive last well as as these they team vesting you to sell trading events, XXBX being reflect Form cover be to up liabilities. to result, a to As will year their tax that that by

I all when I to address open up of that will the just to various you'll for believe expects so long-term we obligation. see add but for MannKind, Xs need to that vest, wanted questions. the again, month. assured Rest some the to in paid thank future in you throughout that we context this be cash Form RSUs IRS and we want

Operator

if Ladies your time, XX or gentlemen, question star telephone please you keypad. press and have on comment a at this

comment, press been star keypad. on press telephone by answered remove again. question Q&A while wish XX stand Please the from the if a or the please your yourself simply you star has have XX you Again, If to or queue, question compile we your roster.

comes the Oren or from Livnat line line first Mr. question comment Wainwright. open. your HC of Our Livnat, is from

Oren Livnat

taking questions, for on Thanks strong congrats the and quarter. another Hi.

and being able listened pharmacies have satisfied. surprising Tyvasa guess to been at the specialty call, about and couldn't dynamics with I more United Therapeutics the think which I highlighting I any demands, to outstripped DPI expectations, some has even So, I led bullish be inventory demand actually not to

So, year, this initiatives And year into for rest highlighted year? of the have us And demands meet through expansions then execute the the I on just through you capacity can you that can your confirm year Thanks. you the next as expectations this next confident that you expansion are follow-ups. and you script? in the all bigger

Michael Castagna

Oren. Thank you,

this obviously yes, the bit give on tried given last comments UT So, we little to extra week. a clarity call

changes We June. in as that and be mode we've every a will and full think supplying made be in with I can we're as to make some sure out, effect patients production daily far time. should UT in by here on look weekly we been close QX basis

Those should that allow as some as and have at make speak are those was. the that what has contracted the weren't off contracts the in that to enough same happening past. build we sure adequate than supply inventory and more pharmacies we obligation of UT to close time mentioned the We and

last off door launch year the to took As out fast. we very went the launch,

gone very The well. gone I think the has conversion have starts new well.

And we this overall, in supply second short continue to make now expectations. to again, able year, impact. half more to and it's patient And we the our as in builds, any future. that doing. It's the the sure through which term of meeting the comfortable from think see increased than getting supply ahead ability we the I of nothing long meeting be And be base to should we term. really we're had do way to all

Oren Livnat

Okay. And segued question. next I you guess my into

capacity for fact billion DPI theoretically in owned that Speaking plant a for their to, longer triple their UT to term, dollars half to your own next on even they hear call expanded I guess, I even was surprised quadruple build year. or are Tyvasa investing

I XX,XXX if you So, I plus in the, behind some guess that And pretty they're patients. now, extreme every revenue potential. growth guess confident did pretty from XXX investing it must mean highlight in million already they're just,

So, possibility whether on investment M&A. that, now it longer your you with, out how not big a real are only of pretty a the the be term surplus, investments hundred are but planning a coming couple we're in into for pipeline royalties for How extra you couple a planning coming a year cash burn, in of end million door?

up you selling large have breaking amounts And of to franchise the flip side, on thought even some potentially dollars maybe for via the about and UT?

Michael Castagna

on this I engine we you equal, assume and growth what you want for meaningful Lots – patients our it's to driver as XX,XXX, wanted of that to XX,XXX, think whether XX,XXX questions XX,XXX, shareholders. because, every show MannKind see a can

I any consistent going plus a reliable, supply. and to have product have company a think, backup dollar wants billion to who's

out a you've a So, one we're UT it's facility. lot, It's It's large. but been fully supportive of facility. facility, because Danbury. It can of build do as to wonderful second a

going these having where look five the think second online backup, a making. seven the the build not certify. whether to they're going as think we're facility to, really and is to I And take going, a backup so, I to in or if the backup, sometimes future things you come at be It's years all UT years that

to five Danbury to years. the on we're capacity time up needs definitely details, next IPF about that scale worry of the some those the than could of meet day, got three end over there's more increase, to things within we've the the in the think doing I So, but at

having second a about feel at or Danbury So, very UT increasing as they global facility facility demand, backup a we supply. meeting look good current

It's positive care. everybody all of and for ensuring net-net continuity

be as you In that over we've out to a ultimately R&D terms into it well, to excess do shareholders the the coming pipeline able with think believe day MannKind. would all anticipation of because happier been be last the that would UT go employees what capital I every will Tyvasa building launch MannKind MannKind in self-fund coming years me, we'd would door in, of and see and four if money do

are it's building do, These enter NTM, one sure that's four now value think I years. to want that next three we been And real the we the we've And make be things three over to [indiscernible]. launching assets for the last years. to starting whether finally it's of of can will patients five and to real

our drive So, that's job, the we growth. the the are make future and about we're is to deploying deployment. to And for opportunities number that excited capital capital one best sure appropriately,

And lot when company, at done you we've of a lot we capital. have look didn't the a

we Now better. that's have to show do It's small faster imagine do what an what big a insulin example, growth capital could we as We're it's that you're we're as that taking bet a you bet, a but adequate pumper now doing. good drive for INHALE-X. could and bet, on

We change company. those types couldn't how the take really of bets, trajectory going to for that's you're future the but

Oren Livnat

Thanks. it. hop right. queue. in All the I'll back I appreciate

Michael Castagna

Thank you.

Operator

Thank you.

Fitzgerald. line now line or open. question of Cantor comes is next your from from comment Our Folkes the Mr. Folkes, Brandon

Brandon Folkes

this about MannKind can use Thanks on announcement prior versus to UT backup? as and congratulations think always and taking us then have would you from Thank own an help question a future Was Hi. you. Maybe on Danbury my the UT from expansion? for question, their contemplated quarter. the potential facility just first the buy obligation and just following

Michael Castagna

think some to Brandon, it's early the too speculate contracts. chain of I supply

don't money supply with a the midterm. the changing They've and the in people. of the near that in XX-year a have I see invested UT. plant or in term We agreement lot

you have Danbury manufacturing, As we into at commercial. assets look a pipeline, of couple for moving the we're for

future. positive There's Danbury. duplicate. So, of there's in there we able going would be that supply expect to at of take to to look time UT a regardless of We the capabilities be out activity to lot some continue to as out unique Danbury

only and facility kind we're the its entire world. a single-purpose in of one As the

of work lot get to ready that second do a a there's to So, time.

Brandon Folkes

Thank you you. very Thank much.

Michael Castagna

you. Thank

Operator

is question or Renza Gregory next Renza, of from now comes line Our Markets. the open. Mr. RBC comment line your from Capital

Unidentified Analyst

okay? you me Can guys Hi. hear

Michael Castagna

Yes.

Unidentified Analyst

quarter Hi, Anish Greg. thanks and Mike on and progress for team. questions. for on the this Congrats It's my taking [ph]

for couple a Just me.

growing get And or the could running? remind for commercialization, demand facility ramp-up in on facility incentives do degree to of any this and Tyvasa continued a Firstly, have up new and economics question. DPI us second user-owned your of to of you I the in support place involvement

Michael Castagna

up I huge a beginning time think timelines. well. we make the running for just that's long make enough important the that the we facility as UT IPF. and have upside That's sure incentive some to goes is of I yesterday. This the every incentive for hope everybody and the gets that is started sure to us a ready think for indication that's to honestly, scale equipment arrived ago. meet We this I

make the forward. commercial to and sure be hopefully XXXX. equipment fall we'll And the here and it to in validating point build some installing us working having in at equipment ready. that we're moving is off a team We're it's product excited. So, day super come night The

Unidentified Analyst

secondly, terms it to under sense inflationary thanks past environment Appreciate you the capital sense XX macro and a how OPEX in do current Great. to any over of the get from potential months again. affected Great. months And the for costs have of of Thanks has just that. change XX on in covers? a just then factors side, the relative

Steven Binder

side. It's probably that anything and Steve We nothing our the unusual don't unusual our low digits, see the or are that's OPEX single one. take way the the here. coming Binder on manufacturing costs marketplace. side in I'll in Inflation up

be I that think out. you're if modeling that So, planning fine purposes, should

Unidentified Analyst

Great. Thanks.

Operator

XX ladies your Again, or have comment press keypad. a on at telephone if star time, please question and gentlemen, you you. Thank this

Mr. comment of Smith from SVB or the Smith, line comes from Securities. your open. line question next Our Thomas is

Thomas Smith

from and questions progress us. congrats the quarter. on for Hey, Two the guys. questions Thanks the taking during

any that impact secondly, to price Afrezza back PAH some then for the insulins earlier year? whether the seeing And you're announced strong of and injectable we can were the comment for reductions in March. data saw First, you sotatercept on from in

how you potential you wondering sotatercept either or positively see negatively? comment use, on Just Tyvasa affecting approval Thanks. if DPI could

Steven Binder

let think, defer the PAH in I the sotatercept. terms the me they're to want market. one on I UT in take to of, first experts

it's used drug. Everything seen, a I've I patients it's combination. in being great in XX,XXX think PAH. There's

I think And, will everybody. DPI us, there's it's the place approved, is enough And, UT room to MannKind off patients on and I'm a very for to think start. for best in when for and UT. that a strong news ultimately I Tyvasa that's market probably the have sure I'll defer in best this how looks.

Michael Castagna

insulin MannKind. not had on small any Afrezza, or major impact On price impact even the reductions have

In some outflows and see at best over demand fact, month our that we're in wholesalers. weeks we terms having the last of of

and track So, Lilly. any is Novo, to the declines happened Sanofi, don't insulin that our by meet our from perspective, it price expectations. on pertains Afrezza see We risk as to

to on They penalties [indiscernible]. took to you it do prices the the only that of XXXX didn't note not innovative price that Medicaid were basal it they insulin. reduce exposed [ph] on basal example, for and they have on non-interchangeable didn't And do glut in those that drugs their did

reductions. not So, been years approved the all five all have newer that insulin, the legacy ten have had price last insulin to the

only exposed It's XX-year-old the Medicaid price really took. are to products and price Medicaid they best penalties the that increases for

happened are three biggest couple to the the these companies with last have over I'm of to because they're that lot were the going in first XXXX. terms in years. XX sure So, of deal a what's

do at doing total to we're to pump we're looked warranted. with cost think And numbers, price an to show hopefully We're value you We it. to of points. range reason payers comfortable plus going care. is insulin leads that's we've However, timing economic another our our AXC studies better support why of our this out the cost proposition, plus

out year. So, and we important the any as just to continue don't U.S., we March globally. growth that's seeing strong changes to in to April, the but Afrezza. and of that think really rest fundamental we anticipate not But the close We're we expect payers,

Thomas Smith

for Got it. That taking Thanks makes questions. sense. the

Michael Castagna

you. Thank

Operator

Thank you.

from question the of your next line is comes open. or Lichtman, Our Mr. now Oppenheimer. comment Steven from Lichtman line

Steven Lichtman

V-Go. Question guys. on Steven, Hi,

that the V-Go Afrezza? a it's see seeing are Mike? been in types those with And Now stabilizing, synergies, particularly looking building do guys you several of as cross-selling for for you you with opportunities ahead field for quarters, mentioned, you

Michael Castagna

I know We're We you've And long hitting you. $XX, high thank May. followed expected. of million for a $XX as last V-Go committed time. $XX to we Steve, the end Yes, that

know takes think do that's we I put question just sales to the go reps been important that is, it's the to I in beyond? months get in-services, those this force. launches, think $XX follow-up, And how training. we really from to We happening. it three five nurse for All

locally progress really line. good the hearing We're on front

where there's to dropping to, that with the So, with space to unfortunately, TRxs seeing I asset. think We've got off due commercial increase the we that's profitability important. We're some early white changes either the indicators the made NRxs the positive. that's of offset

the the pushing for payers? the V-Go manufacturing, been It's different hub patients And patient we are on focused main rebating. product very given here, a rebates that's how we're that retail. paid where removing hub, Afrezza to example, really do cost optimize of to our is So, focus a structure reimbursement the and than not

And different at executed so, We've kind level. there sales force that of models. are two our

have I for V-Go hearing V-Go are think Afrezza. that opening written who the historically doctors we are door

out also XX as And we integration, into of but I just think Our see of V-Go in, last our strategic the integration a that positive part momentum positive reps we'll weeks. And close would continue have impact was in they places never result and beyond. happened move. to which on getting continue that gotten are Afrezza as on QX

we insulin had call product. Omnipod fact, recent X. ad terms have incredible is should a X,XXX demand seen if an it's you to product. the reasons to day, very devices up It's great end I'll patch rise type offices show some type to simple and market We firsthand. think that more boards. X, up GO, the pump. have some look in delivery customers. across We think an now into product. incredible We've everybody of in come I've we at Afrezza use it of And At a

really happening this every and narrow year deeper and focus And a is Afrezza that's for type type so X. And for look consistently week. our we with out two major been go position focus V-Go as that's customers,

Steven Lichtman

I outlook here Great. margin disaggregate firm looked then, I gross V-Go? if but helpful. And quarter. what's on again gross sequentially was the gross margin? margin as in it, your this That's as particular And from Steve, Afrezza we forward that look what apologize we missed

Steven Binder

as we've into forward. combined to margin unit, product just Steve, going going endocrine V-Go disclosing endocrine the business Afrezza gross and we're be

you can under disclosed as in for see, it's prior this quarters. We combined. just So, XX%

a would put You forward. the going those take and from modeling think I you can ballpark in gross margins perspective, that

Steven Lichtman

enough. Fair guys. Okay. Thanks,

Steven Binder

Thank Steve. you,

Operator

you. Thank

Our Mizuho. next from of comes comment Petrone, line or the Anthony open. from Mr. your is question Petrone line

Anthony Petrone

question. quarter another just month A. what when on just the congrats then overall and to so the And discussion here, in on we MannKind Thanks, or Couple from B, here. expecting GLP-Xs, there think patients, products just of expect looking on next good we about ADA ADA, ahead for should timing in should other I'll just there, be how we just X and on insulin out level can some and type you follow-up maybe a utilization set Mounjaro, have us Ozempic, into into that what plays

Steven Binder

with That on Irl over that gave hear us We others diabetes the conference who's proud We've Sure. Anthony, him is personally to really last really Afrezza. and out was you you, joining stage the he announce is of week, other us nice worked which year, thank people world-renowned, came of every it moments. to a AACE and lot just from for Hirsch, years. like hard today. hear great and taking

And market, kind physicians finally, eight excitement, with years after type to gives living the experience some and Afrezza X, good on use his wow. C, starting of us was

I think it, use whole that's you to top on when of of his bunch And that was from sparked how what quote stage. to pump, it a it. questions use do around use a

many, in the years. for of been So, really I think conversation, we're starting to what's for missing is Afrezza context get many which

pump which trial, the one As we presentation trial. we look to ADA, the have on small was ABC switch

recall. I if poster, a be that'll think I

be We're a We've Don't one-on-ones. have of that events going to there. the going booth investment large kind there. events, one-on-ones, dinner at are of engagements. expect lots redistributed and customer present presence to nurse We But year. we'll meeting. diabetes going there, to think I quite rest on it'll the busy presence I'll at be focus nurse have practitioners, the ADA. a We're educators, of and the educators, a otherwise, dinner be

deeper are Those we focuses us for go forward. as

got Your type out. question it. do a we know further the already needed is, which know patient much insulin time We a is time are one, Xs from good only on delaying for that insulin they to the GLPs GLPs

a was history. year think delay about I based on it X-XX

V-Go post-prandial So, that's two it's whether it's need what that of GLPs or focuses, still main just And customers because but amazing, yes, work from longer, make going another control. the to hearing or they probably Alfrezza. our year I'm is, one

better You control. post-prandial still need

You need to cut time those improve you're highs down going if to range. and

XX work reduce showed And ATTD, at minutes we're and the out body. only the substantially. it in that standard. highs data current works The the We gold really at is we than the those gets insulin data showing faster ADA, that

so change. that's not And to going

to customers We do competitive, differentiated make start that? have we understand profile. nice a How

the big focus patient. and product in the we our means understanding to top that the a profile, launch XX That's INHALE-X ultimately the dosing, as what with a trial product, U.S. around centers

So, GLPs great, do drugs. great and will they're

an time down. patients of meal probably plus GLP a be try I looking how use have areas to trial, who to bring the we're stubborn do a to highs think their investigator's there'll want Alfrezza? we study we at, That's maybe help

that clarity. So, helps bring some I hope

Anthony Petrone

just CGM, clarify, when utilization And a with in is GX, think product? XQ. could just that launch the for with and trend can to would have Thanks. just with a that follow-up, Dexcom be thoughts you CGMs, I that a potential maybe starting about just Abbott I'm also Dexcom there we BlueHale on how beyond but quick see collaboration assuming with that

Michael Castagna

once-weekly sticking it months. really easier. wear is pumps having they're I Look, day. at think when XX place look starting we not in once-weekly it's really fingers, someone's exciting GLPs, you when sticking they're not life over look to going at next their finally Yeah. get a be to the inhaled basals, their to to diabetes never differentiated insulin, not but where we're going, insulin for It's skin, patients, where every think getting to It's about easy

one about have to reports we platform Alfrezza, of of those BlueHale, probably excited going send of our integrate and effort, context start your the real-time, you then and with CGM to them your digital the own show and where in we're happening can think I to things is the along we're dosing doctor. download inhalation what's you

to at right them. with happen that just it's patients. it's we we're fully expect make XX Libre GX tight. and and with now. collecting and Dexcom. of kind going not can of point GX, to would it won't It the Abbott all next the what eight hopefully trial value time So be that's at allow us But we will probably API discussions get data the using And We're in get Dexcom the currently I BlueHale bring We'll sure future. weeks, from real-time in you're right, in We're that to yet. through to or showing testing this same some there some there. expect in beta

Anthony Petrone

Thank Congrats again. Helpful. Okay. you.

Michael Castagna

from Thank Nice hearing you, Anthony. you.

Operator

Thank you.

next the from is from or line now line Wainwright. comes comment open. Oren Livnat Livnat, Our your of HC Mr. question

Oren Livnat

Oh, you hear Can sorry. The cut me? operator out.

Michael Castagna

Yes. hear Oren. you, We

throat. my growling. was wasn't I I Sorry, clearing

Oren Livnat

follow I just wanted XXX. to on up

mentioned going You XX-month to that's a study. be

can expectations. even there's more on what as you're give I'm study? design maybe you picture, just that, on are it's color QX, and to just that if and study you that able think no trying accomplish if year the to big on some get now us in call So, I know into last get I this rush towards we mentioned but we wondering

existing share, see just see differentiate treatments? And differentiates market are I but longer to term where want if think you do you you in you XXX from into you to think How the differentiating want from you it I how trying what get the market? existing marketplace? How guess to imagine don't specifics,

Michael Castagna

on you, asking thank XXX. Oren, no, Yes, for

lot specifically. good U.S. Japan days the we're that and think that doing in in coming a is advantage differentiation is real of be first to out turning XX I our with thing competitive dosing. of had doctors research we've of a And I the think

days and we're two months, stop straight, to then for dose XX dose for So, planning again.

dry to available cycles in a powder continuing on to dosing nebulizer life is NTM a play. That step. cycle of We're the very two a be that going we straight. So about two first But only feel for need only work the good approved formulation. terms currently months from will management treatment, patient on pure differentiation

tolerability. going around be is step second The to

love And there. used the through agent It's well-established is a so, believe, an expanded access product. know out Clofazimine we Novartis. globally People from we program

And around know prolongation, accumulation, so, doctors know skin drug discoloration. the it. they QT it And challenges with and accumulation

one that are the types dose do we formulation, lowering And of like remove believe in trial. will we be the to the we those want points pivot key dramatically We really or minimize will our concerns. understand of in

at we'll The know aspects well looking be other FDA. quality those as for be life, sputum of because as the parts we will are important conversion

we and versus this the And Less standard for of sharing that at is important low will a trial outside data. roughly the I'm size The that comfortable of we'll important the U.S., Clofazimine point. but patients. and more U.S., care. collect XXX dose high study

randomize to to take just in background And them one. and one therapy going to not, so general people one we're we're

we've discussions exciting. protocol So, that that's the multiple into FDA And that's really had the current it's going with.

supply available study at IND And be for from that tox time. very we that sites anyway, activating shortly thereafter. one is approved, year. be time the So, on will is going will And clinical the

wrapping We'll up. also be

dosing So, chronic year be The this for a trial. get and will able months. be primary six to endpoint we'll dose in patients

to responding. you're are and TBT I overall think in going We after market. much, it's from pretty we're think not need that And this going a unique an product, we excited. serve after on

line earlier So, of treatment.

Oren Livnat

patient you you if phase a another Do for guess do in registration a this I have of want could to think So, see you package And see, aiming into represent? is study works and X/X, how it one, recruit much what think this that? you're there do you after of particular? to a study particular do to this pivotal type it's you

Michael Castagna

phase a repurposed phase a X to X. calling a because one really not we a X/X. phase on the No, We're drug, it from it's stopgap, enrollment only continuous trial. through. pivotal XXX(B) way a It's all say, need I'll There's

perspective, done pretty finalize the a around generated The have some is be of working design, of that FDA that on show positive do the which we're we part to there's statistical we're straightforward. you So, is make that it's database is has until again, trial data we and negative. trial life, disputed biggest that, quality how world correlation appropriate. as sure the indicated the locked. Probably from single the And trying conversion, analyze to doesn't

data. of focused have present, data, So, sites really important That'll soon now, get interested. time to we day. end package as to that as ground the generate the trial getting But that at And, publish possible. that data, the we're very off on be the the right are

have from asking We inbound to participate. calls sites

excited. we're So,

INHALE-X, INHALE-X, like go planned. going with we've But had luck longer. They ABC, never we've I there's far trials think inbound. take always had be, as lot to so We always of feel a

these is to take experience as that And risks more learning to We're how getting running appropriate as pretty trials. MannKind So, good and doing good more fast trials. we possible. feel them we're move

Oren Livnat

the All added right. color. Appreciate

Michael Castagna

you. Thank

Operator

I'd in over additional time. showing closing at I'm to conference you. any Castagna to like questions for the no back this the Mr. remarks. turn Thank queue

Michael Castagna

you a Thank dialing in be everyone our serve. We're quarter, a first ultimately the of for shareholders the all our phenomenal quarter. been our great which patients only for and in and It's stakeholders employees, year we today. should

Jobs filling. We an higher be have and We're We're multiple avenues hiring time having job applicants. of quality exciting growth. are higher here. people. great It's to

very V-Go be leaving not seeing the to excited we're long Tyvassa, time years the demand and just helping, we we're firing trends Afrezza, we're really seeing this great are to positive patients point, And for get early come. all and year. we're about very, the a year of the demand company. People It's a as beyond we on to here. the the momentum next time QX very We're this into It's pipeline. but and been go year, but cylinders this on to nothing see

start finally you long should been all everybody. to the for that the know So, been the a our we've fruits years. see ride investing thank but you over labor in shareholders, of I it's

great everyone. a So, you week have thank again and

Operator

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

Everyone, wonderful may a You have now disconnect. day.

MannKind (MNKD) 9 May 232023 Q1 Earnings call transcript