MNKD - Earnings call transcript Q2 2018

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Operator

Welcome to the MannKind Corporation 2018 Second Quarter Conference Call.

As a reminder, this call is being recorded on August 2nd, 2018, and will be available for playback on the MannKind corporate Web site shortly after the conclusion of this call until August 16th, 2018. All participants will be in a listen-only mode of the duration of this conference.

Joining us today from MannKind are Chief Executive Officer, Michael Castagna; Chief Financial Officer, Steven Binder; Chief Commercial Officer, Patrick McCauley; Chief Medical Officer, Dr. David Kendall; and Rose Alinaya, Senior VP Investor Relations. turn over to Ms. like now the to call I'd Rose Alinaya. ma'am. Please ahead, go

Rose Alinaya

will within afternoon joining laws. could comments from note call for thank It made these forward-looking on this Good the you differ Please is us possible and actual federal meaning the of today's that call. during stated include securities statements results that expectations.

reports Commission the circumstances cause of from Exchange CEO, will XXXX. Michael August expectations, call only the revise after Xnd, of to that our the the this obligation now For broadcast, Securities and differ over please with statements to is to this or company Exchange to factors filed actual no which Act the date live XXXX. update turn results This We or under contains to the the Castagna. could Securities call. conference accurate and by time-sensitive of date I refer undertake of as call any Mike? events information reflect

Michael Castagna

easy Rose year I've the we the to with to patient been are best one a But I teams company. of greatest to offices. been thank work have company the you It's is in It have who the the face had loyal CEO, MannKind want today. open Good annual call to growth healthcare all, enjoy a one our of I of had our to pains. tremendous well as afternoon together. come. Thanks, you biopharmaceutical I in new share as made year the came packed we strong who believe integrated have progress challenges became we meeting, May, leadership to believe for and transition, year's shareholders assembled everyone. reshape you a pleasure we've where technology ever humanitarians, us platform meeting extremely in past with with say in since XX Diabetes as communication drive our I we you the Alinaya. continued I to years. and Also, the shareholder we today's was position our now not after will see our an growing first fully from

believe Over future over we've a our in City met people analysts most company. world, And met listen Many with we we clinical build year, the around XXX where have I to the investor we progress we buy and in the the people had continue last update New investors to last potential Dr. to growth recent of month, on including are Kendall. we'll the Dr. upon luncheon Edelman return by the to have excited made. MannKind with as start as and see future York

have and has employee the plan, stock low we times stronger commitment XX% average. participating our employee are employees as over purchase of industry which three been turnover, voluntary never of Our rates in our is

program, growth and Afrezza progress my year our pipeline by international pediatric progressing TrepT, growth, incredible During we've with increasing at expanding company have into made when us undervalued measure parts. a stage commercial we driving believe our transforming sum of our I focus. unfortunately look barometer price. the stock failed shows the I that our any I we But in appreciation are see the at major first to

Danbury our million. well to worth patents, XXX as over as assets close infrastructure are that have $XXX alone hard We such as

in $X in our future which non-operating billion $XXX taxes. have balance save We over sheet over us on will million losses

an And in to shaping improved I off, when emulation insulin. of an Treprostinil which I believe on FDA-approved at Al up we is next to recapitalization we it to care the the of the at will reflect up Afrezza, clarity evaluation visionary, IPO the will asset parts week meal put program time some has you once market market and the true last finish have standard was the company value sum look true provide single-product for million. of likely Liquidia become on Mann the Additionally, -- $XXX which top start a today.

to call. We are XX we with around day detail will injectable stay around make habit performance prescribers to we on insulin, of using and Afrezza. commercial time remember share patients progress start have changing our more and some you years on every gaining later new on our continue Pat helping meal and

expenses. of to our Our towards companies. the one diabetes more we're And tightly revenue goal cash and growing premiere customer-focused breakeven growing our is to committed flow managing become by

We ensure with right path remain doctors have our very future. for and growth, the country session in around conducted hundreds to of the listening we're on confident

weekly sales see entered this wholesale of as consistent and of second-half any continue to clinical data our before and we exchange new is growth unit strong We post the ADA. XXXX,

a for announced Now increasing. TrepT results platform program Technosphere continues that in interest the positive we as our have to Afrezza is technology grow, and

QX. key some in Let of highlights me review the

think packaging cartridges first of XXX% one is and I the twice where see compound of when is growth in look much to as starting starting to see been We're as we've and we've XX% growth year-over-year and of pricing you you net are the of TRx growth growth. TRx terms describing that which and year-over-year around what and see see almost cartridge be this decisions growth. our you revenue now out the made effect play growth growing the we revenue mix TRx quarters can revenue then of year-over-year, the

were the XXXX first-half requirements we improved take compared TrepT and and in about ascending Phase you of we at completed was the of When clinical REMS with we announce new first-half, in our a rates million, for second-half as just successfully We expansion and revenue net forward. completed annual revenue range, to demonstrating dose increased million. call. in agreement million, $X India at international low We the our released single than and of X and million go and will We David look end $X.X XXXX, this able $X.X I'll $XX.X talk at gross were now Cipla, look control, forward had Additionally, data ADA see trial look have revenue and was to to mealtime hypoglycemia. the we expected. talk later continued time Kendall June; our this which call. plans earlier about you

pediatric continue almost progress program, complete We and cohort to we're our development X. on

Companion thinking at done what connected business We assessing looking are with and look about they've now the Medical another InPen XXX BlueHale as as for a pathway care at I technology. avenue

reduced And $XX principle Russell debt back our $XX to we that by also of year and last we're index. heading happy the we and million, Additionally, XXXX see million raised July since XXXX to in April. I'm X recently,

Let progression towards cash me flow talk about breakeven. our

million. to million providing We are updated for revenue the year of guidance net $XX $XX

We sticking operating net in used to million to are in of activities change cash $XXX no $XX million.

we get few should guidance. brought One we finishing see in up. the Since where May, of why a major confident the I guidance, items have second-half is be our gave in questions clarity to we

in the Our are given, we the models look underlying to assumptions to things. holding. $X million three at we When see impact full-year $X million following our demand about guidance previously

burn dollars. held on a us conserve we that tune XXXX million to us Two, was XX%. net our net $X join saw Medicaid First, to removing caused our we and happily first-half for line prescriptions which or combined territories full-year to old capital. million cash That to which the our hire in filling a sales the of additional slightly we the about to third, in equal to cash, in prudent a on order million we players when find where of to impair And with in SKUs would've to cash causing gaining higher stick guidance $X mix gross of team, we was revenue impact have in $X to the and $X million when we sales likely impacts cartridge eight them burned million we to expansion believe increase basis. said, the continue to XX% about them. from look cost we'll This vacancies quickly one-time

we market as up go XXXX XX continues in grow. recapitalization some the prescription drive evidenced, we will in growth starting alone. and and recruit us the it we demand enable When of finish into talent to best people Overall have beyond. the to additional As August new

are we see Overall, a prescribers which the $XX And our new growing. the resources growth. is the longer more completion, Afrezza the than original we lot years to and which growth, delivering revenue, million adopt million additional faster are we had territories their continue countries while launch, grow more drive force $XX in to times almost field first first Our Afrezza we as to This to the continue U.S., optimistic people come. to had. year well will we gross year six in and as CGM get all beyond together, program continue remain pediatric want our as that and is for gain will our they

focus now the can core a our sales position better get sheet cash ramping Our that and as flow is possible. the we as so manage expenses up soon breakeven balance

about breakeven. flow the progressing talk me cash Let

the Over flow on million flow a Steve $XX predominant the faster listed MannKind and plan raised while average point, up slide, that as know and the today, base. cash last by cash pathway for well the our started new get way to expect the remaining runway we year, at share. From this of the breakeven. the year give a to the $X.XX over an we this debt At driving will ago, restructuring will we look through believe $XX adoption, asset us cash us able debt outstanding business on We've be have we over million, our flow development our given almost opportunities reduce what price to breakeven put as finish breakeven. debt to activities I been the trial recapitalization and potential to we will

can many to to support way at and not have employees it flow we expect are predominant list will dilution grow breakeven. company, you the Steve. Thank your over and all I be see now the As I'll slide patience, you and the we again to equity/continued turn for listening. recapitalize cash do look to the who our you on options shareholders

Steven Binder

Thanks, second continued which as in I'm as progress good revenue, and first-half Mike, well quarter in company. and our our to excited results discuss sheet afternoon. balance Afrezza the triple-digit restructuring recapitalizing showed so in growth XXXX

financial SEC in XXXX highlights, second financial filed Let's was results. first-half our urge the condensed and I'll start and MD&A quarter the XX-Q with select read the financial statements and afternoon. reviewing discussing you consolidated this be to which by continued

side with start left the Let's of slide. the

the first XXXX increase volume, by impacted a The cartridge revenue and Partially distribution QX discontinuing X million, QX gross associated XXXX, Afrezza offsetting was Afrezza returns and net XXX% as price. over $X.X increase was the million, to a product of this impact. mix, April $X.X net XXXX, favorably from over impact related of XXXX. quarter in XXX% SKUs. was mainly the favorability revenue channel increase flow-through discontinuation was The SKUs these while revenue Xst, Plus

please calls, XXXX previous on changed be aware discussed under ASC revenue that and As of the adoption XXXX recognition our XXX. between has

was volume, XXXX increase reflecting bottom increase the the see second first-half XXX% right over percentage revenue slide quarter At the of presented. net XX% quarter to second in of XX% the and of Afrezza XXXX, favorable gross same million, will cartridge net mix, XXXX. to and gross period $X.X graph, side price. gross net impacts our at Afrezza Looking of the XXXX, XXXX a a the over In million, our percentages versus the XXX% revenue was was $XX.X the you by the first-half

growth, driven by impacted is negative increases, XXXX this line return, there XXXX net the been the about favorable beginning debt. due And hard and to trends. and had volume as care, the sales, company and warrants $XX quarter a million or deduction quarter XX% for our second raising in preventing We month inclusive to provision a net mix timing to which a hands returns returns We've XX% for discussed versus through debt an no to of us third. patients, approximately product million to reduction decrease program The $XX of the and following for principal managed of quarter impact million needed the the net for price the we effectively to normalization of July was conversion of for quarterly X, our second the we the XXXX in the $X mainly impact was from XXXX sum were expectation. paid restructuring and company product product demonstrated as we second is and within the warrants of gross gross went XXXX balance just tied XXXX, remarkable credits of been impact almost When sheet. versus significantly accruing recognition primarily our room. turn money. when in of first-half versus to right gross increase the increase in return XXXX September would've balance there $XX capital. XXXX, months the reduced and fundamentals to slide XXXX with gross was the amount where substantially by paying on work of had six and million of The have year, quarter unfavorably and was we to to that expired million, for from had fluctuations stock in in is return. revenue as around a July, with related Since months, ratchet a down X, has well the of QX, which gross through changes method decrease few to $XX up, net. paths nets the of government a first-half outstanding impacts the net of first-half the Deerfield breathing gross restructure strengthened last I overleveraged the cash. result close This charges that within recorded of to July principal in back effects no to To equity available in ago we through This our our of some of both product our debt To our our at by supporting due purchased the of joined XX sheet. year balance raising percentage July was company's is SKUs price of months. XXXX in our rebates the from longer our as $XX $XXX,XXX. of XX debt due sales Without of which was The for revenue gross is strong we XX% discontinuation Afrezza activity We details debt growth a flowing dispensed working XXXX;

near-term market and close we to three years the it also now. or restructured meaning put have ratio perspective, price for from X, to XXXX with cleared due out higher our debt was XXXX, debt million all the to that no in maturities balance We market debt of different July second-half have To allow $XX balance of at our cap had cap. levels, debt than convergence of debt X.XX, equity the or most at to in company's XX%

quarter remain in We with both of XXXX cash, only As equivalents, to XX We outstanding at months later, second cash cap. ratio average on principal extremely focused the restricted cash. reduce million the our XXXX, our of this reflecting the X:X, balance and increase X, cash. stands ended and managing company's July tightly market the $XX.X

year used turn in -- operating delay looking the to over million the for cash, $XX.X from registered XXXX, back million the our looking we to cash the quarter-on-quarter, in in six XXXX million in we sequential QX, to used adjust QX. call bonuses used operating months, offset sequential of stay as in forecast, executing provide and certain quarter-on-quarter spending cash and net programs activities in reduced To our second-half activities, corporate for Cipla reduced of the $XX.X million for well a $XX XXXX. used insights we commercial as within in from of India areas occurring operating QX payment the and ensure due we we've forecast QX to Pat. direct And for in increase the with to I'll licensing in April, last earlier, at in received that million will XXXX QX of cash the identified over will revenue plans of inclusive agreement. discussed manage guidance cash in we a to our equity was XXXX the net now $XXX the $XX.X in at our the into year net we million, the Looking activities commercial million $XX $XX.X had Mike of million cash raised $X activities, cash first-half of sale to from achievement started continue that To of lower

Pat McCauley

XXXX first quarter our excited you commercial quarter And and off afternoon. you, Thank to our very on we're Steve, highlights. today second we earnings begin I'm good going with where call. to left share

catalyst will this a Type our areas. with training our and with you data XXXX, year, our share in some I marketing to-date of progress reviewed from And positive we to growth focus seen we you had If back May just moment, of in team some in in selling the wanted present for I and remember X impact a March. but sales in these

dosing. addition, the In with significant past our year simplified a Afrezza progress over made we

The we've lot of is seen of important engagements. a very meetings lot customer booth the presentations, a busy other data been significant presence, and we've thing had very, a at and medical many

the strong we the at the continue working MannKind also experience, customer going it focus And speaking Pfizer. ADA are of of years continue sure hard I'm recruiting responsibility have quarter. making to and Squibb, finally, Based continued in be talent top Garrett our in looking access organization, background sponsors held David of forward. patients. August in meet of you industry with diabetes recruiting this as companies to market advertising of Garrett, will sales sales the and as to top new Afrezza. to that team assume ACE, she the functions a believe when included to department. really XX has second Novo really lot decision these with representatives, commercial critical center and in talent, TV will that impact, can the more We're value experience made industry to marketing, high will on to elevate just well talent, to a quarter a about providers we efforts at invest access be key sure to excited our be Afrezza review deep proposition, as further as comes support Sanofi, of our this for and I'm she Marketing who MannKind review teams in sales the a highlights moving we with fourth has and direct-to-consumer moments. she future. joined relationships wonderful state training the healthcare be Chief things and to targeted including disease Team, our years of understanding priority medical And performance, meetings the full review think our access upcoming this the pleased to at Bristol a process Kendall And our few TV leadership to Myers have be meeting, a pilot And marketing; will And hiring across series. and market and aligned and with Also, enhance And the A diabetes this where And customer a Dexcom, upcoming of upcoming he payers bring many have roles meeting with access, knowledge. of experience Nordisk, extensive Now of XX When expand AADE and member PCP really Executive payers. key Afrezza patient has a the many over Officer, to selective ahead, to of ADA over Leadership about should collective going increase one educational Garrett brings I Afrezza in ADA, awareness of guarantee top we're payers. we that of is Garrett, very promotional Ingram some leadership I in help make in only later her market month, Keystone. and also going and the the educational our role, share the will support best

positive assure you running will is forward and can look making contributions. already I So the Garrett to ground a impact, has future hit

almost commercial and really closer I'm it that's flexibility, prescribe you is and process our you and smooth healthcare let's wholesale helps And highly it easier calls, transitioning transformation. team And So And to fully five our Afrezza primary really systems, helps their the because share electronic channels, on this SKUs. disruption with our to for minimize been that transition as has and with and really for at get a helps because focused records it them with within especially important take making to dosing, much look really on it pleased shared patients complete. we Afrezza, distribution is packaging today previous prescriptions by our filled. our titration within professional the stocking ordering. individualized important, health patients ultimately And the that

left-hand side So if look you to almost the the XXXX, at Afrezza you were next chart, in discontinued. look you been can chart TRXs of And in quarter see that the XX% of if have over TRXs look were SKUs. just our SKUs down place, you see the X%. go of in first the only Even first of we're XXXX to XX% at weeks of second transition you quarters, really this few actually five our if you the taking already the in July, quarter discontinued the where can in

there of forward due less XXXX, patients to in our prescriptions be move transitions. filled will SKU Now mix we getting for overall disruption completion Afrezza as the

really that. we're So excited about

know we decision this choice the short-term prescriptions made that believe disruption right create was SKUs. for SKUs, this the into sales is we absolute we to about our one-third about the one-third the it some just the you decision same our in the we –term. Now, do of long within of transition, At think would that came we with in as insurant XXXX time, TRX

contributed move quarter to we our reduction some that a second of believe mentioned through we sales. this, in do Steve earlier, As as

the XXXX right strong continue XXX% control. at second this in the increase in of to look hand our are in of we to you growth see XXXX, of really individual XX-unit titrating side that the patients see that think second we quarter what graph, the and indicates year-over-year the achieve to Afrezza cartridges, if especially cartridges Now, quarter the I from

for we many with that know XX patients XX sure X With made that materials example, our them Afrezza of each our Type aware For of reinforced and our between are to customers packaging also with fully label. promotional make units materials the SKU mix.

very this So talked calls. and excited, on a we're very, we've about I number know

changes, So Since TRX look to And XXXX quarter the XX% sales In when MannKind reasons last Afrezza insurance deductible of decreased of and with of the XXXX the we has for the TRX Afrezza we decline; year. each year-over-year, second XXXX. Afrezza to first discussed team increased launched let's quarter XXXX, some the first some outer has the of changes, quarter utilization. grow had throughout continued our quarter quarter plan shift from to TRX call, some it performance. in second you to do of

Type to we want messaging, our of and Afrezza back on implemented second quarter important I diabetes what to enhance continued highlight some has also in some these, give can our Afrezza the see obviously as first territories grow. customer the is 'XX, some and we've we created the about. But just and mix good disruption, moved of in through SKU that We resized you TRX quarter. the X news talked also

messaging, out executing, in their lift looking quite since and of are update the in been that see sales. our didn't you're on of aware FDA the team, updated we and for received and that's healthcare our trained insights. one-on-one to feedback, we we second label enhanced the back quarter. 'XX, you our part with research, discussions we seen materials conducted We that Based October with market had the As were we've our gain our then we providers sales really believe in lift that

has patients. Let's take that's a the think, brand new and NBRx look from I the 'XX to things we to of important the of of one first-half Afrezza most increased that first-half XX% look XXXX. at at,

and the represents on we brand trial really Afrezza it's awareness, Afrezza. important as continue growth Now this new to patients to of focus and adoption

chart our Type in that over as take as well increase and And of in to now impact within to to also our could new message well. efforts, as look move groups; II period some Afrezza promotion going Afrezza at a see writers. the this brand two forward we do our We're our business. personal expect with and You business the our we and and growth base of sales non-personal promotional base focus both the targets as continues really our efforts, Afrezza

acting in a of the market. at So first, and let's look the what about shares that on our obviously in of market over And TRx subset And when is overall we rapid the NRx call targets. Afrezza is you see this the targets market. chart time think you this it,

in TRx continued you can share that share is our the target increase to throughout see market the chart the Now bottom-line and XXXX.

'XX. 'XX You the the first just quarter market TRx of second can see about share to the doubled of also from quarter

quarter increased of rate in line than think 'XX. the XXXX a the our more greater even I importantly, and 'XX quarter more share first second from NRx and target doubled of it represents at the top to

that see As our to you period may target that due the In Afrezza important NRx some realignment. it's as first drive transition TRxs know we NRx trying well when know, always and decline. sales. the really territory your partially know your is overall We you was of as quarter our this are to customer included did your 'XX, brand to outpacing

expect the rest moving we share of increased and 'XX the this Some the year. second changes target is benefit the in the through The of we discussed forward news newer and reauthorization NRx per good quarter of to that continue prescriptions.

of XXXX, On to quarters we've the of we some of previous quarter compared looked out month last graph, out good our continuing was that the in to really the wanted call right-hand second that growth to we're there side at which June the just seen. starting I shares and of the see a

to move continuing ending forward like we a on we're that with note, So that. we're high

at and If take what you a a way per unique format, Afrezza Afrezza you writer, simple writers same one prescription given are look now, least they and quarter, prescribed over closer here see that let's just at saying of switch the in a quarter. that's

line, X.X%. can the share Now Afrezza in market as second quarter 'XX the in you exceeded NRx see our top of

breadth team. also increased MannKind prescribe prescribing. physician can increase increased since TRx XX% of to You because that quarter cares referrals to 'XX when that it MannKind you think comes And and launch the the excited of really we first is once great have demonstrates it And patient see share sales with each from the clinical that second we made opportunity really quarter to important, a referrals, a depth 'XX. decision of has this that the have and has quarter I'm to of to Afrezza,

verification process. eventually may like approximately of as know It was it patients patient in we experience we Now a benefit successfully customer follow-up approved. you work patient help calls Cares really a really live improved that patients with recall, year, strategic decision Xst experience through for get made that center to this to launched April the all support. XX% referred We the things overall of MannKind

Cares every MannKind to That get seven prescriptions Just think patients XX about Afrezza of that. out filled. their means referred

to the information staying Cares' as sales make well. providers very sure that appropriately MannKind they're health aware on hard is to team also focused working Now highly care communicating to

customer successful the the Type well-positioned and because market that our input. messaging. same the we're think research dosing We've priority we are. our field, commercial we where on messaging sales of of second-half when to diabetes very performance commercial hiring to Afrezza time, been enhanced When believe accountability continuing really about is execution you top done and the I And to materials the very, of at our updated work titration. territorial which team our we've this, that simplified At it, in strategy representatives the for selective all II based the look So do get ahead drive promotional in has level. while XXXX, at we for talented

demand. year focused So of plans to highly behind on of we're executing and increase sales for against these all with drive rest us, things the the our

that continue we're our I a the of advertising when the exciting to And awareness XXXX, think focus will the to provided consumer about be and targeted that direct and one think on scientific I really I with publications is for Dr. TV with look the when the we're collaboration do we'll really Afrezza forward going that also to our we're the do think ways to the to to can of continue. help high know to that that When business our medical on into on one And for One expect of driving players MannKind a to office, prior it commercial our over increase complement to organization forward been authorizations support to and what meal what one we going you Dr. we chief adoption, and Webex trial that with thing so Afrezza related second-half team. care call they continue comes And in the best things that know And educational via really support turn with medical and opportunities, so focus to time do mean we've is that of we is working increased to base an the trial we're these will is they we peer-to-peer support I in-office continued And we're that's know support commercial Afrezza that Kendall. onboard, look we do the interactions really half to they on David promotion sales non-personal that colleagues. peer-to-peer XXXX. now What on clinical the the data the going patients to end insulin. back Kendall I on I'll and working look moving grow, we of we've standard of capability. Cares, and with added place efforts medical I the And focused in removing program of becoming forward side key Afrezza with at really side. I'll all have do continue by the together, efforts the and marketing, for conversation. enhance program multi-channel start continue successful Afrezza. going going patients our by to reducing I And our in keep have to to

David Kendall

the call Thank you you and to very much, phone today. on again all of Pat, thanks

the some to regulatory to my we collaboration at As of seen not like that I of approach of this at aware performed Davis the is during data Center but period and do colleagues second only I diabetes beginning medical trial MannKind, of are time including I'd from great Mike officer the which to a American Colorado potential post medical both study at Many the to analysis pleased opening. Barbara know to University as many colleagues rates of have for what meal sessions. the I'm his organization, collaborative commercial staph insulin scientific at are referred one the space. six-month the XXth of the the the time Diabetes pivotal review affinity here increase the that on I that of and chief talk see in provide scientific clinician highlights new medical results, Association's with trial, between many hypoglycemia presented disclosure the as my and clinical some quarter, you in well data and realize And of

terms third completed of PKPD which the will completion that anticipate The quarter. worth by pediatric noting I the advancing well to cohort X achievement of diabetes anticipated the it -- Afrezza in think early of is affected is our availability be other the population we in study

experts have and including We therapy, reducing the the Diabetes meeting in experts with of in first hypoglycemia an particular interest safety understanding and Board, of of risk also Scientific in those complications clinical diabetes MannKind the insulin understanding the therapy. of insulin Advisory the in long-term convened

ascending of our to XXX(b)(X) I'd study approval was Afrezza focus and and that progressing can of the has Afrezza III effective this are more a and that IND. be of and safe it's REMS In addition, Administration Drug removed is even in the now the as ready It has Treprostinil reemphasize program and Food we those completion part that this application and III risk to use so on previously complete. mitigation strategy in mentioned met so for been its of Technosphere is the Mike Phase evaluation like Phase but communicated, asset single dose to the development the whom communication in an organization, and This we, plan now early by deemed indicated. now been was

like in on but that the expand very Mike agencies and many these review had the activities of have those from inspections will In first Brazil as to we U.S. and both is and well authorities productive of meal in to Mexico Food at data anticipated anticipate the preparation staph study the therapy with successful of of meals. the Drug regulatory as seen and that in addition, geographies. finally, reiterate on Canada in have have of completed further therapy regulatory we regulatory had the Afrezza a the emphasize we U.S. Brazil. meetings international both and I require the where as those you for I'd who approval to outside quickly Administration launch referred emphasize by as front, time the time the highlights. country insulin may And results the submissions

is world case, the study excursions And As rapid a real monitoring supplemental the of hours the analog, is insulin care our the Insulin the you In figure, part to action of profile post Afrezza. many time are post with based utilizing comparing meal. meal standards glucose injected time compared Aspart. impact one of may at meal potential this Afrezza this for protocol two Aspart. of AFREZZA one in and great of doses used a shown on results understanding blood with rapid first the glucose and predominantly acting Insulin subcutaneous to therapy of the assess as of continuous recall, Afrezza this of this in

see, can XX% decrease in in treatment Afrezza glucose following in the meal. a post-prandial for significantly a the meal American in is those greater indeed there hours to hours blood four after Association, in the treated Diabetes And at post difference presented the as in data Afrezza these improvement a compared in you of in the with first the Aspart. meal first glucose more Insulin total post-prandial excursion excursions significant two or glucose As resulted

using per XX a severe less to more here, minutes in of supplemental from patients glycemic XX per take less Afrezza observation, saw that deciliter. this values rates were even values with hypoglycemia of affected and more we therapy XX of glucose and fact day in hypoglycemia minutes And five by namely XX, milligram than in day. home summarizing in this had data blood and were the of treated of doses. total from rates XX of to And and minutes than in we than XX use study less control less the XX per reduction measured therapy the higher the per measured hypoglycemia, Afrezza doses those milligrams assess improved deciliter setting per milligrams deciliter to per its reduced unit addition using with as those time than day addition to to Afrezza the In in importantly, spent on levels who AFREZZA opportunity slide the the

inhaled support but can spent in with the only day CGM in of excursions, glucose And utilizing compared I acting investigators time study spent greater this subcutaneous glucose insulin summary as and care with range. by presented less concluded hypoglycemic to in The range. shown per so with control time improvement values glucose with greater subcutaneous standard of of per investigators rapid are in by care here. summarize the to the acting measured that the use provide So, of the post-prandial day of presented who versus the that did values insulin rapid as staph insulin with standard improved like Technosphere post-prandial simply improvement not these Afrezza the less would hypoglycemic data post-prandial

and the shown this guides is since to last coming medical supporting here as In in the sample anticipate fraction and published addition of commercial is and XX clinicians. This more the we with scientific a disclosures of submission to in original and approximately articles for a and And these approval as a the XX March year, be represent development, assuring that initial focused of of have four group on disclosures, we the that alluded just been activities that fewer anticipated months in days since publication been cases, to in the have the that early one our in of form commitments awareness have or forth that information just years. in publications these or draft with Pat compared Afrezza. coming some an planned publication hope are in And that of review, August. we here review is put and the scientific

alluded critical. awareness is scientific Pat of and So as effects to, Afrezza the clinical of

understanding publicly summary have my safety teams, in effort of and for turn both we're to sure of like this regulatory forth to I'd great And that appropriate that, and and the and put it practitioners making is to proud earnings both who call. clinical information medical available of use, over today's its conclusion So, pleased patients alike. Mike with

Michael Castagna

the We obviously like Brazil updates several are announced Brazil here go well. dialed-in just We -- and on international the us Thank to continue David, real India. audios, well. partner, you, last our understand U.S. is year. I is and some approved you between you're announced We these our better get inspections so challenge partner completed of We in quickly. to insulin versus about packaging talk I continues thank and version web, everyone. want I the as we apologize if it will things. there so to sounds dialed-in

really also trial QX benefits the where pending we have original the of continue to trials, six nicely long weight market. QX that pricing the Afrezza. Predominant and new in go that way Brazil. is within progressing showing to et the India treatment our approval trials data And launch due is premixed a India decisions into in we help expect insulin there plethora XXXX premixed data utilize pivotal a having done We the in going with will as pivotal design with cetera insulin.

to there help and because them it, be with making had global enable patients, to week ready it get that yesterday, the was file-ready. Canadian to Mexico yesterday, it me to a you we David wanting earnings with is Afrezza. cash as and will we back purchasing Tanner talk to and is discussion, Additionally, for or pursue to but world ourselves wanted enables while to them Afrezza the Mexico, opportunity a go we David Afrezza met rights address looks didn't call, think we And for important every and Pharma, earliest Australia. the great Europe in a with later the be have Authorities of to around people markets registers, the to And had year government Pharma Canada no get to time especially product approvals able so mainly the thank people world, QX. get find it's the in name And continue don't upfront it see program around get partner money up that to there and two. will regulatory we in the meant file or still look next we through access we data. But -- global the Tanner in it additional own we year had or patient I the we whether through or two conjunction both a patients I just on additional single of of within this that's over Afrezza to to those lot need called that has to mechanism I their a doctor. get Pharma question be Tanner

had that's why that, so So people to confused. weren't I explain

of have year. if information really been had to over a today, we summarize, heard a but through I lot the lot You last

up the to to that the see the be position our the drive companies wanted just talked in of within focused week, now is getting and We've last diabetes of to TRX XXX And on biggest We're mark and positive nice of top tightened personally be steps by most a really U.S. And thousand say goal for one to outcomes. missed a But the finish more. balance sheet. recapitalization. the unfortunately not to three I to we're volume, payers Afrezza. final on I strive continue lot however, to profitable We we scripts. just demand the but patient-driven

happening we process. eight within growth prior And auth. come continue change get to and the what's and competitive-driven continue protected. I'll doctors the auth to have and continue approved government that the to watch to meantime, patient being don't patients benefit continues the that see seeing have continue as to accelerated ways to to remove only to support, rebates in authorizations do But around models, around times And and say, happens, seven for through they we're when the that if restrictions we us out prior prior Afrezza. of continue XX around, clear as built We we've Medicare, restrictions great

to feel we and about So drive continue are, that demand. good where we would

moving, announced February us as here when international you expansion. our takes Brazil is have largest in just we any around These It five one be out these approval. company. start continue we look years, for and So grow. of here year-and-a-half remind get you, to is pharmaceutical to that are I'll but for the they It time growth continue markets so growing get over will things then for we to contribute of to things years we the later; the to large always years the the to unfortunately We're excited timelines. come. world Tacoma take two beachhead about just XXXX, to

we think opportunity position. forward, that fulfilling to be PX licensed [indiscernible] products candidates looking that. pipeline in look We'll about additional at bag to for continue We bring our bringing

continue who a develop will their pediatric finally, and Afrezza, in And be will And to conjunction for to control pediatrics. forward look a want they're be with to look seeing PKPD additional see pump I alike assets real-time of at kids this things a not results on important. the pipeline parents where attached partner the moment have like We day. then segment also and for to something, around all pivotal the CGMs, Technosphere. partners and some continue

open With from for is on there behind first-half and the all and we remain and place. year the said, questions. team that we're churn excited. I'll focused stop last is in The over So of now A lot fully executing growth. the us,

Operator

first we'll Oren And go HC Wainwright. Livnat to Instructions] with [Operator

Oren Livnat

but but and really the side. go-forward I I to do [ph] would understand -- I is right, you in amount don't just as this help adjustments net so that X,XXX wholesalers, per I -- script I this inven tell. you second current value I gross is That when per first-half you, net you What have hate scripts, implies can something script, as the to sell number could is you full love or for when far can this sell nets, several. point you walk XX the to the I you me with a know if in us, net of understand number? value in which through gross whack value model would be script? and what a What gave the quarter something

Michael Castagna

Yes, Oren. great question,

plus that have when value net per is script to I'd minus. take $XXX QX in So away here our return back event you one-time calculate. the approximately in range, and go of

in QX. at looking least at were that, I and Steve think I

So some of parameter. what we range that that gives in believe you see

the of that is include vouchers. One you things your that see in around may model we don't

So our excluded in is we that gross not report even before report revenue. we something They revenue. are gross

we the report at never in weekly IMS look Symphony when So are you data vouchers or those. there,

what So those are you well. in models our that excluded as and from see slide

Oren Livnat

Okay, cool…

Pat McCauley

of some that. other things key in --

higher, Medicaid price in So a less million number, net let's when revenues. million gross for $X.X you off on X%-X% managed of think coming or call it, sake, sales $XX add that protection care rebates about contracts simplicity

that think care managed to year, side. net that you the gross guidance was the when for that's So about of some on the

Oren Livnat

Novolog. I out I pretty ADA, was seemed of you good had people us month the And coming approximate And the safety me. And a it true time there. of feedback presented have the in conference? there thanks. in I'm first Okay, sort you of the the efficacy just rundown gave of eye-opening And since lot guess seen it and a what exciting think data advantages to versus I all wondering field mean had

Michael Castagna

fine to years shift. about and all with like I'm and inhaled amazing doctors. for listening few shift sudden who required. lunch to just is been understanding I'm But know physicians seems not they're key a to insulin, continues no out got want see the only big how inhalation use function last data the positive hearing seeing see and can sit an I stay have big saying "I think the And here you, but To technology, several I to from over proper to single the every technique, to and coming "There's saying, a learn things, data. it's spend thing injectable". been there three people my history for tell sessions And doctors need with for cities hours of it's I'm And understanding hour-and-a-half two, I the evolve." hours, No, think and behind a to What with then exciting. three, -- the XX-XX literally doing it that's four data, very David this, David, us just test Yes.

And to on adoption. try you CGM keep he are doctors keep so that years more but start person endo just has and one adopting that just for using one And starts starts he for really results drug, getting it eight great and better reps the compound it, practice has how more partners. tell partners will his within in getting I better major just growing a effective, that. growth, tone first-hand. other takes to onboard do that's the He you transforms as One doctor come. to teaches you'll to Yes, onboard, teaches continue can going see like and then this CGM, see and and others, drug clinic And do with where will our jump time. shifted. keep colleagues it'll They're to one nine their example, seeing starts the eight. because, then it, going But using

we and of we're see believe Afrezza the year. there doing we this even results there to we'll I see -- remain a about and CGM So prospects trial hopefully combination, continue excited very that

Pat McCauley

profile end And the lives hour-and-a-half said, and certainly past time-action show Afrezza, I for really insulin. there have with to we learned are Mike discussions be relearning many the to and hour, given practitioners great as can over or add three see the later that, the patients and about XXX we insulin whereas so years that fit an individual having up up hours would four that

shift meetings dinner of held interesting, of we The moment data dinners. Afrezza individuals starting with Afrezza. Afrezza. of we're say, live any these over the And that, are focus to as comes these allows utility the mealtime of So in and of use the content see up discussion their often as to the with the potential the

that's into think translating real-world I how scientific So data are these conversations.

Oren Livnat

can Okay, some thanks. if And here. hog time

the separating would versus basis, underlying be on at what again, the pricing what guess, And the gross level sales margin, On what the front out profit you and me variable overhead understand maybe fixed numbers the can. is breakeven help would cost production you that see? I if or so take current gross gross nets

Steven Binder

not but expect our of time I the all it not is we happen, we're second-half. will time into now second-half XXXX. Steve gross manufacturing at But in of et turn the it entire costs put excess runs We I full positive inventory certainly take can't this when talking. depends profit on and the on some capacity, only negative running tell some line, flows standard I through do the to then today in exactly and our our happen you when in it just production So, that'll production which of facility. that would as COGS, expect costs cetera. have inventory, in course Oren,

Oren Livnat

back queue. in I'll get the Okay, thanks. And Appreciate now it.

Michael Castagna

ahead. other Go Any questions?

Operator

time, There sir. questions further this are at no

Michael Castagna

know to I the little was you. want I again, Well, thank a say long. call

But you given but transition to important to give we complete, these perspective. to work to look continue continue tighter we open and we'll it's with of these shorter, any of investors And get retail really, tighter But get always want you. discussions talk. to to forward thought the thank large calls. will a We continue the as broader on I shareholders. say to We're do our base

the outcome of you. investor Thank couple and of a month conferences have during We September.

Operator

today's your participation. for Ladies We and concludes thank conference. this you gentlemen,

may now You disconnect.

MannKind (MNKD) 2 Aug 182018 Q2 Earnings call transcript