Recent MNKD transcripts
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| Rose Alinaya | IR |
| Michael Castagna | CEO |
| Steven Binder | CFO |
| Pat McCauley | CCO |
| David Kendall | CMO |
Ladies and gentlemen, thank you for standing by. All participants will be in a listen-only for the duration of this conference. Welcome to the MannKind Corporation 2018 First Quarter Conference Call.
As a reminder, this call is being recorded on May 9, 2018, and will be available for playback on the MannKind corporate Web site shortly after the conclusion of this call until May 23.
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. Alinaya, Investor Rose and Kendall; Senior Relations. VP, David turn over to would now Alinaya. call to like I Rose the Please go ahead.
will made Good afternoon call. this the comments today's the Federal possible expectations. Security results us joining statements Laws. call meaning during It of and thank stated Please could you note differ for these include within forward-looking that is on actual that from
any with expectations, XXXX. the could of We conference cause site that and I be our of by to actual please from Castagna. statements refer Mike? live of as turn which the circumstances after call. differ events this filed posted exchange CEO, on to accurate the call. Michael date call factors undertake is under non-GAAP date after or For with no the reflect obligation disclosures call Commission of broadcast, update to company Securities Web Exchange reconciliation and information this or the this to reports to the A X, presentation results May will only the our now contains this to securities will time-sensitive over This XXXX. revise
you Rose. everyone, afternoon. you, good Thank Thank and
of our You your looking of call, patience today's to show sessions as in we the lives, a year-over-year QX the hit terms where quarterly as the really less XX% as may into we our quarter continue thank really data of team at up guidance. Coming level as everyone for New XX with I've who sharing XX% of this this -- into Afrezza, our get information. out today listening several forward them presentation. say key as to had ADA, you platform, of we continuing go I we confidence going, delay progress. about with between York, the We growth in around getting into conducted coming about company and California, make insights and to so update go fantastic notice country, there be through their met the is Texas, with a should did payers of of slides of want building members to well year's
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TV improve, The We'll coverage the thought environment. continue faster will continued balance direction David we're to in the Afrezza sales We the markets. share day to for air QX. impact before. plus a example sales grow TV So reps than that in to on TV was continue now we that going Pat see the have had bring opportunities force. will that you in of One that we pilot, look we And and will to as leaders and key really to sheet retrospect walk to and the has can turned start in give onboard, through.
on continue certain ability this we looking the turn now are that that future to quarter on back to We reinvest TV impact funds the to in to has know sales. accelerate
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looking had under growth new So the at XXX guidance, ASC we year-over-year. XXX%
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so in within an cash very take we're last really thought We activities And end. a rolled will you as on building David walk already think entire the promotional on and executive helping the articulate you new our we will strategy that, really continue and and QX. of science, in And analysis David job impact call. met through opportunities I new used some operating leader phenomenal at team, Pat relationships, Net those walk through. has was that us at we're a guideline result Steve earnings crunching forward. as our to Kendall data that Stress the done early out go seeing to questions fine-tune happy in though million. late-QX any $XX.X
scientific a pipeline you forward as Afrezza, our with see in as look Treprostinil initiated forward. that continuing seen platform to So move have We may well earnings. reorganization our around the to corporate
such We are Village, and as Danbury, functions to from Westlake California. Finance HR Connecticut moving corporate
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timing can oral to reinvest that the capitalize $XXX deal is us. we we those are presentation. we this results. for as controls you, share study and That market accepted results really something X a to looking for during well Phase Afrezza. this ADA, as a a are of The can company As that week, a and insulin. Therapeutics We three-player that as hours. four in seen have to as one We and dosing in it's partner We put will for will data a a believe asset remain as meal-time as we It that convenience so continue presentation for an in study poster pump. study important going is category. with million you show will United and post-perennial announced competition against that may a we Dexcom's is And go be was Treprostinil opportunity to significant QX. we to believe look We readout get this X-ready be we've soon looking at this range CGM did to a STAT just head-to-head last injectable believe intense potential differences that at using committed remind forward And believe for Phase we differentiation. demonstrate will had not the
and poster in reinforce had we've what our have raised showing We we for the our hypoglycemia accepted on all agreement first had educate time Post the with look and Afrezza of I'll on which the it believe important continue very start the seen and data we'll an is of And completed license REMS time program month media their other last about. Brazil reason you can data I'll when talk there, the of as demonstrating options. trials, QX, the responsive. Cipla, across last really we to ADA plus at STAT in and Brazilian differences filing. our safety was The meal that around significant the morning expected. they're have, April. approved And that of milestones. plus makes efficacy physicians the XX $XX.X then out versus hypoglycemia device and this sure week. mention the India we people with history We social We complete we that million We progress product earlier dataset the than other Afrezza this is the inhaler insulin on For thing charts. we've the executed late-breaking
me global Let about expansion. a second talk take and
year, last year As we with That revenue around it's help opportunities out sitting on streams we know, that the here continue we to Last remains we'd it's Brazil. need year, an started build something not track. diabetes be living people world. waiting for urgent had to additional to not announced this and but
late in approved that year. We are early get to excited QX see or this hopefully QX
The morning, just is India, announced this Cipla. second we one with
four we in XX will people one soon to with have as the expand. potentially we expect continue announcement, to this this as And living option as get diabetes approved six with for So more Afrezza that to sooner. guidelines Phase month, approval be Indian we realistically but months. new trial here but get We chance is a small required, X anticipate XX will SCFDA a under could
strategy to today's started information be to filings the we've partner I start that some able other regulatory already articulating a additional working in prior of the so working hope medical strategy, you announcement. markets, also have soon. already on and with and got We our with head on We're to share
term sheets for some quarter. try key we go to it in third the have have infrastructure we respiratory selected markets leaders into share negotiating Additionally, we of because will Cipla one could in second other believe the we started in is they get products. understand reason but quarter and They India. top in have market. which done healthcare XX% within market diabetes, They are they The
a is about of drug understand incredible. you partner diabetes and when really inhalation able aspects the having experience So being to think the
on to get their striving a You been look collaborative may time something really enough had this that's with, in insulin. difficult relationship. And they'll markets. model. to recognition were been it you to they not cartridge yellow partner, pipeline it able endocrinologists and to accomplished. find and developing great as make one some It's say it's be to to meal believe three something go when don't that teach The important being penetration old also The an I our meal a approach easy or they in revenue looking and to who of extremely over show in times before and severely underutilized. prescription, net forward very to And learn. meal these already already into people allows which take to people revenue helping was have very us help achieve based or We is time we is Steve we that wanted insulin I already at may turn has our partner time very control day you bring educators inhaled really India we've the have a is struggling them under access what thing know, we to
if to was this QX thought you employees. a MannKind year from you full-time We've very the sales we quarter-over-quarter to when it So through in launched first outside $X quarter organization. do hired QX see, of show here small would've were the contract you own force saying when probably of a $X 'XX as million can all sales dedicated of million growth force, And continued we'll 'XX our are with sales the we MannKind stretch. XXXX, of way sitting it These you first progress.
the about through data $X on to XXX%. We a we Year-over-year, will gets are here sold believe minute. post as in million out we that to do we've in basis. But talk ADA presented. progress up we're QX reaffirm continue can that especially that prescription this guidance Steve
new we as for of progress came to had year, important to it's this start the during of as Steve. just point, the we are that to care to forward at confidence prescription, to At all I'll compare the we member us to very nature invest positive how MannKind, continue out we're back. our opportunity the the to QX. when to it our over These With rest objectives achieve think co-pay turn that, and because MannKind all I give look referrals, corporate grow of of go wholesalers. really MannKind indicators laid that product we cards,
solid seen and has our XXXX efforts advancing selling sheet and Afrezza. balance as plans, our promotional well as restructuring for afternoon. good and both Mike, in progress recapitalization Thanks,
financial statements I'll Let's financial reviewing to the and the MD&A results. highlights which contained urge is XXXX be financial first quarter read filed SEC discussing consolidated the start with this our XX-Q, by you afternoon. select condensed the in in
was For the XXXX was was adoption we being QX The the two the retail longer decreasing the we now March price. million impacted XXX. recognition million, that aware patient the favorably filled the of have the continue ended recognition Revenue has increase direct under in QX which revenue under mix XXXX sales based wholesalers. was December have inventory been return amounts and patient between on March Please would net changed over recognized our at XXX% XXX like ASC sales revenue XXXX. primarily standard, level three under the increase net XXXX corresponding $X at that for which customers months prescriptions channel the and revenue XX, on recognized fills XXX% Afrezza but revenue in difference be whereas sales increase no under million revenue when based million is to a XXXX resulted XXXX of QX levels prescription. $X.X over The cartridge XXXX or by and XXXX to $X.X Afrezza recognize to between in ASC recognized generally increase is revenue recognized in for XXXX and recognized $X a time would If existed XXXX. no demand wholesalers to XXXX when standard right due net volume,
XXXX net rebates XXXX and Medicaid. taken versus such the was growth in and resulting Our government for programs care mainly QX to the managed percentage in increases in XX% price XX% as XXXX due QX
significant restructuring been the net on expense We has mid-single debt sheet reductions includes delivered increase last four the negotiating diligently Deerfield reinvest continuing expect successfully Afrezza. over balance the XXXX. this of and remainder digits amount debt. approximate as the Mann of as notes the in our for interest considerable XX% growth as also which saving balance well in reducing the debt, years. to which a This to to forgiveness percentage our sheet, We've allows working the restructure as expense facility senior payable the money financing By notes convertible to behind related the to obligation the to commonly referred referred interest to party we're Group us Sanofi
of of total at we by ATM cash, the quarter cash in over on sources reduced extremely of the $X.X XXXX the $XX.X million interest net year $XX.X XX bringing in and activities uses been reduced first XXXX, of million the XXXX, XX% versus our were at of to we XXXX. cash, the We $XX.X principal had March burn March we QX and XX% with or from our operating million last a raising the used of $XX.X of For started XX, December XX, our focused balance in expenses by and has XXXX, first reduction XXXX three $XXX,XXX cash months quarter million. debt remain cash the or tapped million
revenue $XX.X a a continues million us million in to model Just lower net with of XXXX. $XX million offering after for the our our ended, raised net QX the We quarter the of $XX.X put as revenue range in million equity first expenses us cash. of registered $XX putting in we end guidance to direct reaffirm start position to
expect of We tempers single year percentage to increase to in net net digits revenue the remainder our forecast. which for our XXXX growth the
experienced later Kendall Chief McCauley, Conferences more Diabetes will interactions we addition, XXXX our expected softer this information medical for our our Major this anticipate physician a QX on of growth in in and Officer and Officer than strategy but in promotional different detail the Commercial TRX from new describe and at presentation. remainder later new David growth scientific year. resulting In Medical from Pat trajectory Chief
through in million $XX cash to in of different cash $XX before cash all that for to will as operating weighing number cash raise these funds in a still be combinations the best million you the results, need of company. the hope million year-to-date this forward and options sources $XX to we're We for our To or million on listed analysts for in path for slide in into our the our of million used expectations raised able of the started with guidance impact range that range. see it we're we in the This determine means of to also possible in year $XXX sources $XX view and investors position the million used million financial $XX and confident giving will offering the plans activities. achievements, I'll XXXX, we provide insights maintain additional transparent to equity cash and We turn provides XXXX. remainder $XX.X the activities over cash I into and of our commercial Pat. operating activities, net a
first share has to capabilities afternoon. at hard quarter few focused we Afrezza I to make and highlights XXXX about Thanks, our with our ensure know continue on over our as continue excited very the MannKind, transformation and Steve, diabetes. been and team past that you patients good very talk with I'm In the months, living we've to building commercial we successful been today. supporting commercial core we'll working
that Mike you one bring about sales XX experience a organization they transitioned recall in selling learned different mentioned to past Now, in quarters we've contract and this, few sales we what may along we've representatives February about many and things hired MannKind. and back now full-year new are of excited the have also way, the and from
a territory, so sometimes, takes group know this be what as about excited a you much As have for really in it representative will six full impact we're as XX to doing. to months new
help year and team excited every clinical relationships move sales and diabetes state as us year business deeper Also additional into help to materials I'm investing is we're awareness finally, is capabilities with our customers that in team experience As sales additional the forward. day developing to two, of and our drive with selling and such really customers. the acumen. each we're build disease we really one our gains we and to that move reasons going our skills Afrezza we team knowledge our and in And second our adoption continue sales of going promotional this as
Now, believe Also the go a quarter you'll acting the if you quarter you from has see that this generally this XXXX prescriptions is just time first through has period. to during happened sales about from in the doubled of at fourth but end if impact X% for see the look can the of that Afrezza with team rapid line chart, an XXXX had you of of XXXX we February the XXXX and declined few reasons. class
guys As changes in regional that and reset New in about in talk reminder, just a and ongoing, utilization the and transition are minute the some you the been know plan first in quarter, voucher deductibles disruptions some quarter. caused insurance decreased Year pilot through territories mixed that went Afrezza NDC fourth the as which TV a customer I'll has resizing ended
and believe first as can prescriptions XXXX and the in we we've delivering our executing these that more expectations very our Now, these we're is moved growth, that results demand. you well-positioned March, plans through on returned quarter, sales we drive focus Afrezza did have in in can know that we things our team place. high while We against to see occur in the have and for we
NRx, into brand. closer and you of also take to of you based our whenever our new a XX% and quite from prescriptions the lot of we it a a can take to to closer truly bit first let's and prescriptions So of the see look specifically new look XXXX, as on demonstrated refills, are questions that many prescriptions portion different some XXXX know I growth Afrezza at first strong mean get quarter of that the an And at the things. on wanted a quarter
a simply switching that's be a new could a it be provider could new prescription or Afrezza it Afrezza example, For user NDC current a renewing a insurance with that current unit to package.
actually on NRx the to patients that who brand. there prescriptions have not On are represent new are other hand, that Afrezza been
there two a over this were of XXX take XXX% first and of a at those XXXX new bars Afrezza the In increased the to XXXX, So quarter of the patients first look them at that and quarter slide. closer growth. the actually just see and you to in XXXX patients let's can represents bottom in the about
to the year, the think you of this our XXXX, in of Afrezza about quarter first new were So of it first increased quarter of if the and in brand patients XXXX. all to over XX% XX%
our So and of in refills on based one at patients XXXX four are XQ when look today TRX three on represents every Afrezza of to new approximately four truly and renewals. we patients brand every
this type this of to of that over we continue demonstrates is expect base and our growth Afrezza patients So building and new time. increase well the
that's So going let's lot really you look take you with packaging cartridge excited and something and progress I transformation of share Afrezza a closer at shared on our a we've great and there. before to know I'm with that's
you XX% guys know, three closely our easier SKU left of side wholesalers, if to sales the is it SKUs eight the into being option SKUs. we especially pack patient of think that of the look we single at for not our of the quarter additional XXXX, first time all the the about now as in stocking electronic discontinuing SKUs. patients transformation you our under transition. mono But wholesale the XXXX into there's discontinued a a quarter provides just primary nice this or and place, an sales primary go can and within same of the titration, a working the chart, and in going SKUs individualized As flexibility you our of health progression know Also to to are reefing get think are importantly, based ordering, also on why see XX% primary at currently offering were for in been even about and that so now a and only prescribe prior to are we're going you'll most minute XXXX healthcare to hand taking X, that you it dosing XX really you was five five first provide five back can process cartridges and April SKUs records very unit the if see And a the when with if providers, important? either Afrezza, for in is to be this this you smoother it's shipping our much channels
packaging, our offering So our are customers patients us excited and for we positions this and beyond. about and it when to comes believe XXXX well it in
If basically respectively right you units is side, XXXX, on the achieve patients XXXX at first units quarter quarter at grew the the look but some similarly see is to and of the you four important of the for glycemic XX% this what's first growth require more can time customer at as some eight based hand we of think control. to and of the on XX% feedback then four, important this that but XX trials, eight of clinical growth our the because know meal and XX I cartridges significant revealing the unit insulin XXX%, and
with there meal they in between news our and these patients, may growth we strategy. Type XX we the believe each XX and X seeing unit units execution for are our of Type X XX need patients is example, great our and For and Afrezza that the
priced with cartridges, compounded reminder, the value and growth contribution. a represents this as insulin also of Secondly, increase an XX are in linear minute
are site and media, continue going information Afrezza already Web that a YouTube, definite enhanced understand a we our and is the education to live social of patients Web At Afrezza, additional sharing and I'm these for in site a consumer this we take in with look some digital you not the how really invest Instagram, helps very information. to leveraging at works, and only traffic great how of but important the traffic and to help product resource drive that same we've patient awareness overall and obviously time, drive with and to seen well. our very safety excited experience to registrations So advertising Facebook, as efforts we're increase started get site to to now share are let's know
this TV both Now, when have. TV of quarter looking this in reinforces that continue non-TV definitely something gave we the our riders and increase the versus to and earlier our promotionally different this markets, from with effective at that the we're is in that's markets markets our commercial, advertising to in definitely mentioned Mike pilot, TV continue The insights, fourth results an ways we see responsive. many we Afrezza the comparing Afrezza we saw most markets that and TV prescriptions
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that as with excited force well. we're its going In and skills message clinical evolving about is with top at insuring in talent the value our our we we about to MannKind recruiting the landscape ensure we And bringing always training that insulin. over selling we team have Afrezza have and culture successful. It's clinical executed whether standard out to and the and believe investing MannKind, be Our against technology, really fine building about the foundation continue number care a I'll talent, one closing, proposition. people, the to focused becomes that David understand fully lot field moving Afrezza will Kendall. meal-time it Afrezza turn we work do excited top also the payers with going we're at plans be disease the that asset our the but of place be all those. and the to are going all on and know forward and right I'm people to that, of as or And to and retaining them
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a reviewed you know, was in its prior drug in device of U.S., is device approval collectively the many XXXX. as Afrezza the combination As to
program Our two paths. in Brazil has
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dose year. existing in can approximately program, are Our accumulated in here, extended this And we planned which I'd the that anticipate Mike latter X based we from Results over pathway, that I've a TreT This to here thank we like to a half standard single which very have initiating of XXX(b)(X) mid a wealth data pivotal with submission completion quarter. we Treprostinil timelines the which data necessary join is, X case, is shown And inhalation comparing first will initiated it first then for XXXX. of study. early and XXX(b) continue therapy. this the what into to both Phase team in the study, and for XX midst of be clinical ascending ultimately for I'll ongoing Technosphere and available the of a information development, and second these and Phase anticipate entire with trials. months, of to the and a back and provide, that's that, and is development had will of which care, the turn Treprostinil is for summary data With of we nebulized is to hope a the Switch on anticipate And proceed Mike study from this that, we opportunities year. MannKind, analyzed the late quarter study the in the pharmacokinetic required of
and David, you, Thank Steve.
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