MNKD - Earnings call transcript Q3 2021

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Operator

Good afternoon and welcome to the MannKind Corporation Third Quarter 2021 Earnings Call.

As a reminder, this call is being recorded on November 9, 2021 and will be available for playback on MannKind Corporation website shortly after the conclusion of this call until November 23, 2021. 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 the 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.

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

Michael Castagna

We with everyone. having end quite it afternoon, And apologize who's that Good I figure out a audio the delay. problem was. and couldn't for were

and we're where [Indiscernible]. I talk Equivalent, So in about apologize, going. we've to not our we'll and try do highlights, been, let's where and speak right operational jump I'll faster than

our shareholders the think thank we the support Obviously, First, news get over to I who executing hard we Afrezza we few U.S. and it's something and we'll to ensure for and growth feedback that we'll was through, our QX on last scale, the do want worked manageable expected, pipeline, but the not months. so that few Tyvaso something talk also weeks progress received our about. a I DPI are during driving in key want X priorities; to our production of employees thank ago

pre often growth overall, growth at I future XX% area, drive of look We're XXXX, really forward. year-to-date, over As QX to collaboration. happy we've as hire the -IND I and as Number to come the couple about expected demand manufacturing to On our on we known began start talk year. XX% of see you X to year. let our Danbury to QX. talk we had revenue I'll we really to [Indiscernible] revenue, and you new over XX% revenue, positive share really coming future to handle the data continue we to really, proud about I'm talk In X, look total things. on Afrezza. and data [Indiscernible] want of for some grew out of million An was forward but we're that a in the plan those want go to results, last some And expand looked our with million on we pipeline going XX% continue next had that Phase which the to commercial in in and $XX facility know we $X.X and at in as Afrezza last today slide, you our here studies [Indiscernible] units

terms our Additionally, and for with we're we're of wrapping almost done work TGF near in just IPF formulation of up also ASMI DPI data innovation. dosing

area, XX% prescriptions. on the Afrezza experienced year-over-year growth paid On Endocrine

launched currently, driving U.S. U.S., we on effective to focused weren't we January we in recall, As resources venue. by the year. you patients Australia which QX, to in We We've exited decided and and Afrezza in QX, QX. we in X. pediatric our any happy sites liquidity [Indiscernible] of were the X our free up with as this today. and came UT going, programs In is running, may our into QX. trial ended that priorities, the the direction are in we as top and cease as refocus here we co-promote removing out goods we believe of these collaboration. best ended We resources our are distractions We pipeline in for related enrolling MSO X quarter,

We going strategy global continue our potential forward. will look ex-U.S. to helping for partners for

will drive worldwide. faster growth best ensure U.S., in our For short-term to which success here the impact is

had $XXX are million front, on to we top sale really we at of of the of close for On liquidity September. the end the million $XXX today leaseback proceeds, happy

manufacturing response for Therapeutics absolutely a complete analytical capital to future great substance. an A do single deficiency be news with hopefully this be testament is earlier. it's scaling possible issue do indications. DPI I deficiency had forms United third-party are on summer or any noting labeling DTRF. we DPI, expect MannKind, used drug think we will and that no growth and earlier. in and received indications focused which [Indiscernible] This factories is approvals completed, facility resolving Tyvaso getting we citizens same product could that nothing think, we towards for see not end On our of we're you to on warnings we XXXX as discussion Solution not petition see Tyvaso and than 'XX great the didn't Users The focused my The that with for cited purposes. it's into the our seen. have later the with at and us we up asap, was approved, or have or Tyvaso of for issue, today, or Inhalation but as that we've future products. [Indiscernible] of Tyvaso prelaunch by contraindications well-positioned of the efficiency PH-ILD, the box on [Indiscernible] summer for

we has offices in had in U.S., QX. a look had Delta's at shutdown early we COVID we the We've -- as strong headwinds on As Afrezza focused again. some QX very

between quarter. distraction pediatric scaling get going X, we calls on commercial we've we wanted. ready that the hired everyone that's be QX pilot in the the January a to as We will and force in That onboard. Number studies running sales to Southeast, off direction track team trying us got more FTEs XX liquidity for about X, also our as refocus the and added wasn't launch. it, present enrollment to primary the end having for Number ground, energy which care the the

never this the during chain. command, of is in inventory called, of about, third-party what upfront focused having were new switch middleman nearest can And to will their X, when can The from which on be and has Kevin FDA Xx we to witnessed We average. the a first on ultimately this share third our FDA dataset the we doctors is from want XX% Informed this exited something signs thing which off with in the what that pilot the to from CGM QX stockpiled the a the expect the your update which with we reimbursement their as we're in a see involved who oral Company presented a the top We'll down best focus better chain, to of depends is the and on Afrezza of just As with pharmacy in to Xx how XX recently past you of inventory model to accepted glycemic our say launching we And data a chain MIDD is, history, nearest driving using Dose here, our Program streamline could latest in what with Afrezza. we those improve for is Drug the in-charter really will that we so for first the challenges just to We're lot instead change have And and XX reflect seeing costs to potentially first dose the prescriptions now see patient, after really the we will on it adequate our our presentation in effective as And discuss understand actually coming you the first to realtime control And further informed focus these people we assist we label up down One chain. label. term see is from us this is new you better basically Afrezza. QX improve hope this dosing we when Model is believing. Pilot that days conversion are left to continue I into X XXX got cartridge. we retention X that XX% control help in of early hear launching Returned new weeks of the And kids, change this the to reflects Afrezza. that, chart label present treatment, week been access can means can prescription convert doctors, how label injectable program, And formula called, influence. versus Afrezza. of X. use value Development see patient dose We what along is dosing weeks momentum by new control had to within of dose get does simplify data, right the And the rounds we've is, launched kick December. see is of patient up with QX. trial round saw in consignment Kaiserman. an decreased our and better new know Thursday the upfront Afrezza. injectable you starts and you this they

X, X, you per by what rounded to would round that about if translate would be XX by that's see a the a almost is example, you to where subcu that X% just on data we to from you at over endpoints. switching changing AXC towards X% newest are a And Afrezza, with and is besides else all show XX this And hours. dose Xx For is of generated here, reduction milligram your end want you does AXC, if we for improve nearest That deciliter Afrezza XX, maintain to X down hours. down [Indiscernible]. consistent nothing multiply the the

I and off talking it turn the over I'll will Now, about pipeline. Steve, close to

Steven Binder

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

of driven third Let's versus rate $X.X favorable start of of the favorable and in a consisting Afrezza price, cartridges TRx for of XX% quarter versus TRx more reported quarter adversely gross the net $X.X third XXXX. including to growth and by COVID Year-to-date increase, mix include more million the symphony Afrezza a X% at percentage revenues paid XX%. the pandemic. gross of net percentage. XXXX. growth of both was net was price, XX%, a XXXX, and impacted reported The paid growth, XX% were components to to XX% demand up growth growth for of of XX% by by more including looking TRx favorable revenue million XXXX, of simply XXXX a

on contracted increase activities consists revenue additional decrease R&D $X.X collaboration's revenue UT representing versus $XX.X for million for a in $XX.X mainly and the a to and due XX% was services, the our second quarter Therapeutics margin gross Moving obligation. Afrezza shows on slide, The revenue from graph second of The collaboration, collaboration in million million was services associated our the $XX.X collaboration supply and or GAAP recognition of on period for services used September the XX% performance a $X with the to and for licensed with increase. which the is million. and fee year-to-date was mainly XXXX, basis from year-to-date year-to-date, for the amendment September to in insulin and amount next exclude Non-GAAP of the our United million. recorded The quarter adjusted a quarterly expense basis agreement

Our excluded Non-GAAP basis, on a gross basis, and increasing XXXX stands margin, been quarter each during amendment and a at GAAP XX% on year-to-date XX% has which the fee.

to tracking on manufacturing the timing for impacts gross where cost have goods better the which providing margin finished looking believe, our continue Afrezza, and significantly numbers, running margin, is perspective capacity can and in current year-to-date performance. the on the bulk excess depending We recognized of Afrezza fluctuate products. manufacturing our I at of for quarter-to-quarter,

been which manufacture substantially our makes commercial for the to from and as million anticipate XXXX to we completed. plant impact an our We well efficient, towards favorable quarter on the year-to-date. scale deferred is PDUFA time United as This through $XX.X performance million in Tyvaso about recognized have presented overhead revenue, growing information head started on development outlines $X.X obligation Starting October XXXX. which during September we Tyvaso the Therapeutics. of third XXth September different in XXXX was [Indiscernible] in over to the There we're basis as a slide revenue second costs to future, fourth this being and more performance ratable earnings how expected with approved by our Afrezza at sold $X.X expect quarter to associated with as recognizing to Therapeutics revenue revenues. gross with is with to we expansion the the date million revenue, performance the period FDA margin have services, obligation in DPI, on recognized to which relates The Looking associated start expect license United royalty the DPI we of technology the we sales obligations Tyvaso once net performance obligation recognize call sheet anticipate update margin each and on and by the of and BPI our balance quarter. recognizing that, clinical

then to the services, approved signed and disclosed, royalty next supply is specific The performance is we in be in associated August, double-digit, which a the low commercial be recognized X have obligation amended for the As the As XX with is plan products more United to had as commercial rate FDA. but products once is manufacturing we by XXth, Revenue not to products, DPI commercial Tyvaso sell previously we extended manufacturing agreement agreement UT. and October, which to in sell will September years. begun of Therapeutics, to begun

quarter delivering revenue between represents lastly, selling is XXXX, begin quarter. being margin activity. next-generation percentage were which -commercialization services, and during upon and completes third United our respectively. a the this September help represents and We fourth profit performance quarter revenue not of recognized when some in better. costs a able expect The second The method recognized year-to-date Therapeutics MannKind with incurred XXXX margin third the for also products first to of delivering the with in I of timing and on performance agreed light you of second certainly obligation and does This The We million quarter the is I in which collaboration a quarter a UT $X.X to the does have million recognized area the amount million next confusing agreed has and Tyvaso year-to-date. associated XXXX. pre upon the obligation not $X.X hope $X.X little the to MannKind costs was profit DPI incurred periods, And by services. understand R&D, have the by the and shed and

a mumbo the with away upfront accounting our UT over strip -jumbo, and X-year we've over collaboration recognized which in period. you revenues, If milestone $XXX yielded technical million

for we for has to by expect to started to work which quarter. UT DPI, begin selling fourth associated have our perform which being additional are producing We and agreed with compensated UT, Tyvaso product effort manufacturing commercial the in we

cash our Let X+ over resources on ended with facility investments cash Danbury sale and added our investments we financial stronger third yesterday. Today, than from me Company $XXX with dilutive the million - conclude the approximately with and $XXX the been some balance liquidity. approximately past leaseback in million of manufacturing comments years. quarter are financially final We to closing non and have our we of

to momentarily, shape business make for for our good over updates which return provide our behind comments. it back Afrezza in look some to investments I'll higher can business, blow complimentary growing now are to pipeline, turn We development our of targeted and fund which this, might rates shareholders. for deals Mike additional that are With

Michael Castagna

else. thank Thank you, you, And everyone Steve.

do Afrezza, take the With not see how the sales impact on focused able now proceeds really can can we closed, are on opportunistic opportunities which you we've the to past. been in

without growing and today we're fast any doing people. our a do hiring rapidly. so cannot robust than It's physically more is more we that pipeline Additionally, growing lot

going probably pipeline happening disorder they've see anxiety. QX talk are lot started For reason shareholder to coming. talk X, accordingly. what's that's on slide there's Phase February really wanted think glimpse when but to a we'll Phase they between But slide a and that then, till in is They the their well really March, pipeline panic that On focus particular, could not are we're call on as acute of I looking in cannabidiol, is take another X. on I a you the as in about at to shareholders have the step this they next now for positive back of the things year, and closes,

pleasantly We this with shocked data. are

with Clofazamine We be you this know sharing to works. time. We first the for are excited

of about So XX data, through good bought we're last already in really we excited our how that to it see mid-December. the acquisition Qrum days effect mainly. absolutely it's But post this

host to impact for these it a come low for that, least saw the So not the lungs a concentration the recently long dose effects look you just you days, And dose fuel at this and the to as the could to, we in XX, side, are in medium drug to dose and at fast line. what looked which and from there's much And then XX you we a X really designing which relative faster. we at no in think dosing, from times very its down. animals dose high here Because has inventory significantly another in levels drug see innovative is days, just the disease, versus it I'm before, this dose this vesting disease. much green It's you and the and top plasma left follow new of data can to side us in drug, stay at make in want [Indiscernible] concentration, will therapeutic specifically the it's plasma. and plasma, showing about the wide you less want could which got we and the how for how clears, the this we liquid the before And did tell and trial. XX really high, LAN starts we to the exactly minimum high than MIC, We that's time lungs is higher is see long window. how drug levels differently dose-limiting lung at

this we brought in already year. IPF. formulation. get will with we evolve, lungs, design patients thinking that show lung product really We're the to We've in half-life [Indiscernible] [Indiscernible] put we effect profile as seek levels levels the interesting as it's forward. patients incredible go, to with moving systemic a Phase work they continuing for and exercise the expect is. here. development do last treat in we pre are for X. QX. in -clinical PD. particular an it side that systemic already to what in what about next long to -- task excited was And But accretes June. do the certain we're X in finished up job and how that exactly to Phase how with By circulation. just that FDA the a And as rights something excited we that want The are the year levels inhalation really this about This going to the and It what target, as are announced dosing beta we that have pulmonary PK in known plasma and about team, to this this really to readout You're agreement MannKind year-end because we license super But is fibrotic continues tell we to this in the just that powder in we're technology the have see Thirona and minimal us allows TGF circulation then full to headaches about our And rapid window. mature into That's diseases. dry

Thirona on. developing for for this to fibrotic also a remind is they for Just focused you, scarring. except everything in we're breaks dermatological that And retained lump-sum application keloid

talking quarters, [Indiscernible]. as now, about next out could So QX Thirona a over into we'll get look really Number the we for in but XXXX one, X see things. you program right of the couple just I'm

XXX, a, MNKD X on have Phase will We Clofazamine. is which readout

couple money? by but end today know by generate Phase come alignment readout, And is the get you We looked on X opportunities lot this starting will XXX initiation rapidly months out here over months, XXX, done, end will into to tox of the scale are see We ask and at the started safety be grow And X the initiation arise QX. on published. on that year. We'll the guess may data the a meetings pipeline we collaboration. of could that FDA they all because will Lots ramping have with Phase roughly get I that'll previous a turn deals any best XX There's formulations, excitement year. in by studies, [Indiscernible] XXXX. of this ability of continue to see our the work moving the you. We've so Cannabinoid data It's This X want MNKD the, in QX. Phase we Company, of opportunities years. is that because those we with really excluding be X the the on what all a to over will coming. see share we're know why in MNKD external advance. can of years, additional we the then estimated of raising into few This is us XX And next the may have we Technosphere pipeline to working in now up, XXX, the to should by then when data new and to collaboration [Indiscernible]

The could look CRL span would absolutely we it's the But As had United fast it's an to at has want by. a November, for win wrap for and up ready. I Tyvaso unfortunately a got the DPI record the XXXX already successful year say, on, Therapeutics we manufacturing Obviously, scalability you but amazing control, did an job data milestones, the very believe getting time. can't clinical we did job I the crazy in very, get we the team in to year. good year, a team gone approval, the see our just of process how in a on

we [Indiscernible]. today than our been. to it's growth MannKind in stronger the approval than trial. to Company the brighter the we've So that, progress round. is And first far clinical a clean struggle front a particular as In us, X [Indiscernible] that up on doesn't [Indiscernible] years. ever inhalation for future of ever been products effort. this QX would we lack see the in it's overall, do case, made Double-digit anyone can of of technicality And within we last But happy lot hang the are the had as

there you questions. everyone we'll will and take stop thank to So

Operator

Gregory from time. this of first from Our Ranexa question. Please Markets. line ask instructions] question the Capital [Operator RBC your comes At

Unidentified Speaker

is this you on Thank the for for taking progress. and Greg. Hi, congrats [Indiscernible] our questions,

Michael Castagna

go. [Indiscernible]

Unidentified Speaker

you hear can Operator, hear me? me? Can you

Operator

Yes, ma'am. can you. I hear [Indiscernible]

Michael Castagna

I give to of the it more from start meeting. and we one analysts our our as experiencing minute. the technical do apologize shareholders difficulties We'll

cannot. You we guys can hear your questions but

Operator

could me. Excuse presenters, hear you me,

Michael Castagna

It's our apologize, to Okay. ready have advances. technical everyone. any there's the any on will the analysts And but here. late Obviously, are are. a know gets forward But challenge we hear hold, retail here. We're these obviously a tomorrow. I I we of And email have cannot take we join meeting today, and started issues shareholder call don't Apologize to that who thank a To want go [Indiscernible] Rose updates earnings for smoothly way. and you, we after to hopefully going those you calls must questions, obviously you today. meeting. retail how for apologize get I organized type your difficulties. try we shareholder to eventual probably or have in to jinx that where saying Look please listening ourselves through if alarms to I you for any fire IR that. topics and in this that.

Steven Binder

on. Hold

time. Okay. Thank you for your

Operator

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

may You now disconnect.

MannKind (MNKD) 10 Nov 212021 Q3 Earnings call transcript