CHMA - Earnings call transcript Q4 2019

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Operator

Greetings, and welcome the Chiasma Inc. Fourth Quarter and Year End 2019 Financial Results Call. At this time all participants are in a listen-only mode. [Operator Instructions].

As a reminder, this conference is being recorded.

pleasure Corporate your Communication. my VP, Dawn now and IR is to host, introduce Schottlandt, It Thank Dawn, you you may now begin.

Dawn Schottlandt

our Today and clinical not timing of operator. statements data, commercialization of our you, we review expectations making approval European potential be Thank for on potential our certain development regarding approved. about and events regulatory to and in and cash launch, Union, circumstances, U.S. plans limited plans States size but regulatory the MYCAPSSA, included statements the regarding capital will our and forward-looking markets and release of expectations our and commercial the if needs anticipated runway United for and MYCAPSSA of composition

due the XX, risks detailed well SEC to including subsequent those are with Factors XX-K year Risk uncertainties, ended numerous December XXXX, Actual statements These on materially current and in based of for the the expectations. filings filed SEC. as our section today with Form the our differ results as may

as result update these as information whether any forward-looking future statements, by contained a obligation to law, Except new or otherwise. in information, events Chiasma of disclaims required

Affairs; President, VP results. Joining is Bill Mark Senior Chief & Raj of who our and Medical Clinical Executive the Ludlam, Fitzpatrick, will review Development financial Officer; Kannan, today call our

now would Raj? Executive turn like Raj the to Officer, call And Kannan. I Chief over to Chiasma's

Raj Kannan

joining call financial anticipated afternoon this XXXX our for to recent everyone full you the and milestones XXXX Thank fourth operating our Dawn. highlights, you, quarter Thank results. year discuss and

for extremely adults December NDA We capsules, our be early late conditionally acceptance FDA and the quarter the resubmission of by MYCAPSSA the for the to oral the its of in in we octreotide was product The this named of resubmitted lead were notified with treatment January. maintenance past pleased highlight of acromegaly. NDA trade candidate,

as X significant of an year marketing Trial the This CHIASMA OPTIMAL Chiasma included highlighted to progress Phase results positive key MPOWERED™ approval Global the completion of Phase know of of application was milestone the MYCAPSSA European enrollment for Trial, is the a and the of the you that in which designed and for the for a company X Union. support

look I to a the for Chiasma. be year transformational XXXX milestones, potential our has As anticipated at

With FDA from the date trials We of target NDA OPTIMAL resubmission, clinical XXXX of the a the additional were clinical PDUFA CHIASMA providers. data acceptance that XX, singed to the insights June present at healthcare action to offer scheduled relevant would ENDO XXXX.

the As conference in Francisco you San know, canceled. may ENDO was

society with ways endocrine expect seven to and We term. accepted new in medical the our are the working to identify near currently share and abstracts with the scientist community

launches. me commercial provide why take and high disease few our from we planned level most launch differentiated traditional a a to rare commercial believe minutes strategy is of it overview Let

we First, analogs treated believe identifiable. relatively readily patients are somatostatin with injectable acromegaly

Our treated X,XXX less indicates accounts, our XX% primarily endocrinologist. than research that by of of targeted population composed are

on patient this enable in differentiated that resources target to our use a patients, efficiently expect We highly platform. while focus we services us will developing identifying

of care potential focus itself. than standard endocrinologist injectable rather will and our believe active allow daily an prescribed MYCAPSSA, have on where education three this in We to octreotide on over well-known healthcare of therapy octreotide, education for is familiar the in provider are Second, decades. a oral the a us ingredient with form benefits about

overall Third, drug by of many that and faced differentiated we as burdens budget. injectables, the while minimally addresses an impacting option payers important their may on significant SSA MYCAPSSA believe patients view

we people. between confidence gives has if a executing us XX market launch. and Overall that is believe that we team approved, lastly, believe its with addressable the for drug potentially customer facing successful And MYCAPSSA specialty, unique orphan, on XX MYCAPSSA U.S. small characteristics ranging

our two in manufacturing the XXXX. of FDA pending before, supply, supplements plan noted launch secure commercial to we of As planned of quarter we MYCAPSSA and API one fourth approval NDA to our

for to our growth the to Now, our designed more our oral platform driving Chiasma, diseases of develop for mid XXXX other lives plans expansion treated currently long one turning therapies suffering announce being we term with or pipeline utilizing plans to from debilitating therapies. in to that technology are plan late improve patients to injectable

over organization. turn this At like to to Bill. and clinical our I discuss key Ludlam would point, medical call the to of highlight Bill

Bill Ludlam

have this we Raj. share year. you Thanks substantive to I'm far the excited with made progress so

OPTIMAL publication We CHIASMA acromegaly of the in and MSL our for progress began hiring completed our plans the team, enrolling have to on manuscript. the registry, continued

team. with me fill out early hires to in critical team this some We and year. great made Let our MSL start were able the

the play hired team a existing top treatments gives great will and that in engaging The a tier patients, have talent on on believe MSLs the medical need includes will scientific of us of educating significant a key in healthcare acromegaly communities. I role unmet and scientific MSL burden which exchanges. we professionals team. appropriate focus Our engaging

was multi-year State the in to Acromegaly Disease The the Registry initiated registry. The enrolling MACRO of registry registry acromegaly called maintenance existing our we a U.S. study. enrollment Registry on highlight I pleased Another have or patients currently that am is initiation of actively report Management therapies.

of of the we over care interests and with we important various days associated burdens U.S. current the am and pleased involve that will early yield thus Even world with in registry treatment this enrollment, that physician are on far. and I effectiveness the and clinical patient received real hundreds very the XX have patients expect data treatments. of standard We sites, though

the due Turning to coronavirus. over to of spread the ENDO conference XXXX, the canceled was concerns

on We share this we seven accepted committed widely the expect exciting are so. to was medical and ahead additional the trial posted OPTIMAL developing to plans some CHIASMA presentation in our We relevant included on data weeks share it are details that the that community with that abstracts were the important the provide is opportunities to in clinical believe to website. doing data ENDO and more

it a peer the team Trial and intently on review Our submitting publication and journal. completing focused is Manuscript for CHIASMA OPTIMAL

We that in to published have expect mid-XXXX. data

Turning completed following XX% Phase release in was X from We octreotide clinical as top line briefly a to patients capsules. to with MPOWERED data phase of quarter trial the six remain planned. randomized third XXXX. to our Randomization run-in as month trial MPOWERED, track on this January continues protocol the progress fourth global Trial, per responders to during of

groups. forward to patient assessment relevant reported the of comparison look SSAs, and this We study MYCAPSSA head-to-head the outcome as comparator clinically efficacy with a two incremental data in injectable to data provide such between safety of as the MPOWERED us as read-out the versus potential data well as has these

to a for request marketing EMA support potential As application. an a designed reminder, MPOWERED is

will financials. At to I Mark. the over to turn Fitzpatrick this call Mark point, review the

Mark Fitzpatrick

December expenses Thank you, XX, and the Bill. administrative for of XXXX General $X.X compared million same fourth $X.X with XXXX. period quarter million ended the for were

ended XXXX the General December million periods initiation which year and primarily $XX.X administrative with for related compensation year the were expenses activities expenses. reduction the XX, compared legal and XX, a The offset were $XX driven both increase ended million of for XXXX. pre-commercial expenses December for by in primarily was by

costs, by primarily XX, quarter trials offset Research $X.X million December XXXX. the increase period manufacturing driven of was increased XXXX by fourth the decreased and for same with and clinical costs. and expenses regulatory $X.X for development compared The were million ended

the immaterial, year December expenses XXXX observed XX, Research was ended a million costs, for and XXXX. cost. offset the an Though XX, development year compared $XX.X regulatory with the in in clinical change increase December were ended trials million and $XX.X we by manufacturing for decrease

for compared $XX share or a with For loss of net $X.XX same the loss XXXX. per the basic or basic was of quarter share ended million December $X.X period million XX, per XXXX net $X.XX

XXXX $X.XX net of per For the ended share, same basic $XX.X million or loss year $X.XX net basic million share of period December for was per with $XX.X compared XX, XXXX. a loss the or

Cash, proceeds completed In that were $XX.X public XXXX. with XX, of XXXX marketable at cash $XX.X raised million approximately as XXXX net securities aggregate common December of equivalents million XX, Chiasma and stock $XX.X compared December of two million. offerings

sufficient such anticipated of at results. XXXX, currently have the of FDA my to commercial fund planned the key top cash planned approval Phase as we operations the resources U.S. release and MPOWERED X believe milestones MYCAPSSA, as line our through launch least including We

We will be capital. to to our beyond options may available capital However, we financing our continue that in explore needs. additional XXXX, meet potential to operations order to us fund to plan require

I will now turn the call back to Raj. over

Raj Kannan

Thank you, Mark.

would make couple Before to opening a I questions, like comments. to call the of

At macro Chiasma the uncertainties. environment with we current realized is and many challenging volatile

closely where we this assessing have take business year. ensure monitoring are Chiasma to achieve on track remains can, could milestones this to and actions We on plan and we our our appropriate any to impact

be current going Despite a environment, the is XXXX continue Chiasma. potentially to believe I to transformational year for macro

patients, acromegaly our launch. goals, our of focused beginning U.S. We approval including followed strong for the the are on planned MYCAPSSA potential by keenly in to on commercial a executing

This concludes our remarks.

the open to call questions. now your Operator? will We

Operator

Fitzgerald. with first [Operator Instructions] you. Thank Cantor Please Folkes question go from Our ahead. comes Brandon

Brandon Folkes

taking that for that questions manifestering know there, key off quite Thanks send post all just Can we progress that approvals. the approvals congratulations post in Hi! my you manufacturing we will is the you on should think required the PDUFA; on you perhaps know what elaborate XXXX. what and June should and about get simple approval

Just any additional will be color helpful.

additional that, mentioned as And I Thank think [ph] color brought great on just you goals should you well? from be then would how had following commercial we but know people, XXXX? in maybe you. on about there some

Raj Kannan

those questions. for you repeat in about XXXX, Could that this commercial Raj. just Brandon, Thanks commercial is word what?

Brandon Folkes

spending. Quota,

Raj Kannan

Spend, okay, it. got

take to let and approval supplements, the I'll XXXX. So question the Mark have then me manufacturing for respond commercial

Mark Fitzpatrick

Yeah Brandon, thanks.

anticipated sites to not the are submit manufacturing the approval, additional referenced resubmission. following that for we supplements manufacturing to two So API expect provide in

API two we from currently these of We API sites approval. are of the NDA have anticipation from in in procured and past procuring both sites these

of product to adequate manufacturing our the quarter NDA planned timely to availability albeit of expect FDA's launch support in two fourth in XXXX, these subject We to either a approval supplements. have commercial of

Raj Kannan

on Brandon, organization account only we is reps, in as you center the our – XX a which I the know, customer that patient case personnel sales that managers, as not the commercial MSLs, but targeting you includes support, any we as gave And well we about the personnel facing managers, are the assume call to XX the before, reference also spend have.

patients stated places and managed than the audience our endocrinology small is anybody a know less are also X,XXX that by we as – XX% we’ve XX think to be accounts. quite you the and So of XX who customer, before it'll

So therapeutic and in in hopefully line in go will we efficient rare we spend orphans that specialty small disease other very I Brandon. be how hope to with our this market helps will always be area, particular launches.

Brandon Folkes

much. very does. It Thanks

Operator

Our Please go Yasmeen Rahimi from comes next Roth ahead. question with Capital.

Paul O'Brien

question Yasmeen. all the progress. for on Hi today. Congrats on my team, Paul for taking Thanks

and far Just a people can commercial so many have little more color how two a put we more little questions; more, many get first, add expect? How just sales in been regarding to rollout. place

then you key talk octreotides current in again. back of second to question can to going about a physicians? can comments about your And endocrinologist, gaps see prescribing understood framework awareness if the that prior among – use educate well just about forward what Thanks we going and kind being you

Raj Kannan

question! Paul. certainly other first Great the terms but from sales candidates onboard we Yep, be as the approval. that just So for a they field company We have would post would look obviously would gated coming have perspective, thanks only any on in screen reps, and approval qualified one, of that. done

and the sales we do in with new and terms current have but they that they options. the potential key scientific of certainly They're in thought these sense of not rep field. needed care said, on facing be in particular, would are what's needs state customer leaders from being engagement, especially engaging the the That have in MSLs

question. first the that’s So

been and last was going have the comfortable this surgery as in octreotides second very not awareness. in in of out octreotide three the I care question or option. who any molecule don't a patients of and XX is this was agent to and of key the a for that an has particular believe is surgery in to decades preferred nine over eight failed physicians have because standard remember, gap product gaps terms The awareness, as sort of

I to MOA healthcare we're believe efficacy octreotide we injectables; significant where focused and be itself. the oral that current helps safety is and the to hope of treatment So are going octreotide really get do our putting think focusing on. profile the focusing or we us, on education is have burdens on educate We on face the comfortable that's patients that part them we're the the not that Paul. I on to providers that with

Paul O'Brien

Yeah, just yeah, follow-up. and a

going well acromegaly guess, and how how forward that is educate kind approaching I how that? how So think about understood and should we – of endocrinologist guys to are symptom breakthrough about you

Raj Kannan

Paul. question great So,

a recognition Sisco, the – such that especially symptoms. I If is an by that First, acceptance symptoms. see can vocal, is would that think awareness patient you we the say the run increasing becoming breakthrough as one more is advocacy there on of about communities, and and patient definitely more voice the the clearly breakthrough that and the Jill

So it’s more clearly XXXX. in what had we much than back

put able We certainly are thought the leaders that engaging to perspective. to with be in

new dose at that not route convenience on to that, offers key We of focus will and but than papers that the administration. ENDO the whole patient’s become have the more we daily that to a Tulane that symptoms of MYCAPSSA we perception breakthrough as look the a lot at sort and of out, continue publications option speaks will an the the oral physician’s last between certain to and put a disconnect understanding the option, just

Paul O'Brien

my course; for Of thanks much taking questions. so

Raj Kannan

Paul. Thanks

Operator

question Our of Wainwright. HC Douglas ahead. from Please is Tsao go next

Douglas Tsao

for guys! the taking Thanks Hello questions.

curious you they're to down. and to the dramatically drug impact specifically Just that make MPOWERED of in, especially in can to Italy supply having assurances being able – are potential patients it, go an locked have where patients provide first, around sure term obviously to just update been able of coronavirus if access things in and making the

Raj Kannan

great question Yep, Doug.

and particularly Italy patients this to do U.S. that the trial not sites. about enrollment, me say, who I'll at particular the I have the in still talk MPOWERED. particularly had over are overall Remember previously coronavirus in it time completed we has Let but the impacted we disclosed Bill, in turn to believe

Bill Ludlam

Thanks Doug. Great!

good So the the an issue. there. out issue got shape We've drug not supply clinical in to so supply is finish our we’re trial,

the will the open still impact that in in the in not primary that do of The but endpoint. phase, ex-U.S. are patients the have only We randomized the patients some RCT phase are label, course U.S.

in with able have patients. their being they closely working needs in terms U.S., the been We've the to see sites met the that sure making of

where We are have the get sites going the necessary patients working to towards draws in that. for being that hospital, interactions, their with remote the associate appropriate we’ll able blood where don't fear of do in, a

to a that come. to able we're patients way in So most do where able are

If those there get averaged those TWA for reason one they of point or the data some some of is is missed the are point, if advantages points one of analysis missed, simply a of that out.

nine is the TWA there's of for And example. IGF-X space one so average prior month simply the that and miss two if the months simply count throughout the taking and for one would

Raj Kannan

I comment Italy, only the And Doug add is right. on would

that have We the XX label currently trial completed in open in clinical the and have one of extension. MPOWERED are month site that Italy has patients

we trial that a from perspective. completed core they've need perspective, a from data So the submission

Douglas Tsao

know sales you we're fourth the as to the guess Okay, know on will that's you follow this have detailing as have move to and fantastic. And that that you up explored think that do but I have sort doctor’s we then about by be you I – too methodologies access same persist it’s issue obviously, think premature? where limited will a a topic, situation the of this potentially offices, and quarter, reps know it's hopeful past you all alternatives an thought it we'll still extent or

Raj Kannan

receive so matter. engage many I compared sort any channels, probably personnel assess are will even in that because messages of launching wanting and end I has think, would to in to with our even was past know of up I of our our become launch potentially and my today, and shore continuing digital know strengthen you say, I to that of situation before years and our plans you think up a our more centerpiece digital products the we customers when

but are Not interactions shoring engage anybody's means. to blow mention certainly know we and our different to guess, this still to face that when for are person not the the face most up customers crisis we to in but are over, and but We via that's alternative up effective, do ways channels. planning will

Douglas Tsao

very Okay, great. Thank much you guys.

Operator

ahead. Our Sandler. from Tenthoff is Ted go next Piper Please of question

Ted Tenthoff

hope be PDUFA would staying the delay I potential be do I we are of how side should guys and could communicated, are I matter the the how down part areas they safe of anticipating had much. FDA. if healthy. be in Thank section, guys. as get earlier but you the date communication scheduled, for And a a you the PDUFA a to date delayed that? you I just update. review, missed Thank all you in on case shut or apologize with what the know appreciate this very a that on safe

Raj Kannan

we Yeah, communication FDA time from hi great Ted, delay. a any the potential question. have about this not At do

know, of this There could we we a the us be is which are of in a a and there potential of you time evidence our resubmission in inspection at efficacy do a As with point hands tells a very there's focused if Class X site any be ban, the know that safety. not would that sort review and delay. travel

We our immediately. and to are planned we communication sure things informed delayed, do get had that are achieving that we'll our off learn are on a investors be the to certainly from milestone make still we going FDA as focused if wider

Ted Tenthoff

you then – sense. very for the when is comments. reason But much too won’t makes if be hopefully hopefully much. the Great, it Thank

of is octreotide, be And meeting? there very panel one would be mean agency there should I very you comfortable, or so a I familiar guess as one, with not necessarily? any just expectation other anticipation said, quite an

Raj Kannan

the of submitted one an one, our panel, We do committee. At the panel last Great not application. we have the I not did I be there have at when we know that from time assume signals do not from time FDA believe advisory Ted. is we this any this and question a would

anticipate to we doesn't ready one So do but mean that for if right does the one, on we're but have organize the one. not one, certainly FDA that happens. Difficult] [Technical not one

Ted Tenthoff

and all Great! answers safe I stay and appreciate healthy the guys.

Raj Kannan

Thank you.

Operator

Kumar Markets. Our ahead. question Brookline Capital Please with is go next from Raja

Kumar Raja

of required both Do site be would questions my taking expectation of progress. completed studies that been does and for the timeline? terms QX what what between regard to Thanks is the be difference With impact Has inspection? the stability them? for manufacturing of this to you congratulations all that launch two think that on and how the going supplement, in and facilities, is

Bill Ludlam

just comment. me add overarching let an so Yeah,

is Mark a of two and this stability the through details FDA I two had whether studies whether think sort gone supplements, Mark. for Overall give over insist the question. thanks ready the our think that and the we mitigate they're appeased, are not one those the inspection, will definitely to them question, it's submitting a post-approval and turn the estimation around on if so of risk for of I but and great chance from to a that supplements I'll site

Mark Fitzpatrick

Sure.

had So resubmission we we risk outstanding had a they NDA as as regulatory in to resubmission want the setback December, didn’t manufacturer having that an a had a observation submitted of and not in Kumar that. we result

we what is can prior to our plan choose add PDUFA manufacturing has to every prior two the they on regulation. months submit a understanding supplement approval that approval of reason which believe If we inspect the is they another to to do, So NDA, the months. data that that the four once supplements we run that have following FDA

review has manufacturer, in with We site, the encumber scaled second up to resulted not which we a resubmission date in want new NDA June. API which to XX NDA facility which the a a did So clock. our supplement PDUFA to have always the we intended following may month have

ready inspections the we these completely for that So any and result. of suppliers are that supplementation may both process believe

Kumar Raja

in with just you would the with do is patients happening the MACRO expansion, or insights registry, patients terms on And these what's And this they Any continue will to label the include? MYCAPSSA be drug? terms happening? in of the this can treaded patients open regard treatment of what or share of what

Bill Ludlam

Yes, thanks Kumar.

on nobody registry So state the octreotide. There's a disease registry. oral MACRO is

go experience standard are they becomes drug will have available, of the care to and the at the drug. and oral anyone simply MYCAPSSA, onto option octreotide the opportunity time experience would onto – this assessing give on to else once on the us We before they on drug, assess an their this like after go patient all go they

and So world will study it baseline not switch will a control head-to-head everybody a world real opportunity give real for probably over, us since an comparison.

data all very landscape. physicians, patients, that So interesting the how drug will hopefully involved become it parties be new will impact rich, this available, treatment to will very to

label, to-date portions set those open label, consistent there the in study them of and on OPTIMAL is up. in two as with have the terms with progressing is MPOWERED CHIASMA label. patients – study studies, In patience open planned, open has The open how always ongoing we does are label the those met we very said as the

Kumar Raja

will a and maybe terms FDA, And time of label to final discussion the line the the label, what question of label what with that? in expectations the the the in for are with be regard terms

Raj Kannan

this question. Hey Kumar, Raj, great is

terms we the to clinical sort that label, of the the In of had in experience label we've trials. replicate our expect

that analogs tolerate is So them. our can are it'll who on something be somatostatin and clinical trial who patients reflected, certainly which

is demonstrated. for, of trial kind the would that go that we line would results which that clinical language be in the So with we

the Usually terms but is part on anywhere speculation the in you actual to what estimate get would review six are the of starting the to on four FDA, But those we engaged any at label. that would latter that's between terms with FDA engages time. this not my of negotiation, weeks on a say In just with a the usually the period. towards of FDA negotiations There's part timelines. I label the with specific

Kumar Raja

Thank much. you so great. Okay,

Raj Kannan

welcome. very You're

Operator

the at Raj back to like closing There Kannan further would remarks. questions are I floor for to no turn this over time.

Raj Kannan

time have thank forward would quarterly and to speaking to macro we I to say what at remain front next on on a that call look our you environment, of is May. continue Thank Have Thank confident a in disquieting we here all again with wanted milestones operator. you, for but update in just evening! joining a we you. us you we good that us call the of

Operator

concludes This teleconference. today's

may You for your this your Thank lines time. participation. at disconnect you

Chiasma (CHMA) 16 Mar 202019 Q4 Earnings call transcript