CHMA - Earnings call transcript Q2 2019

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Conference Call to discuss Chiasma's Second Quarter 2019 Operating and Financial Results. All lines are in a listen-only mode.

Glenn Garmont

Thank you, operator. Please turn to Slide 1. Today, we will be making certain forward-looking statements about events and circumstances, including, but not limited to, statements regarding our development and potential commercialization of Mycapssa, our expectations on timing of release of clinical data and regulatory submissions and review periods, our plans to seek regulatory approval in the United States and European Union, our anticipated cash runway and the size and composition of potential markets for Mycapssa, if approved.

on based are statements current expectations. These for may uncertainties, including results of well Form the as differ XXXX, filings December Risk materially and risks our SEC with filed the numerous our to XX-K year those as section ended XX, due Factors Actual the with detailed SEC. subsequent the in disclaims obligation to future forward-looking a as whether new any update information, these Chiasma result or events otherwise. statements information contained of in

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

Raj Kannan

Glenn, for Thanks, second joining call this and results. our review our thank you, everyone, afternoon quarter to

Fitzpatrick, my me Clinical since first Please President, an are our I'm review to Bill results. I Development is in pleased Ludlam, at June, who and review want This join this company X Affairs, financial transformational and of the is such X. the Medical time. to There Slide Mark President will organization who Vice points OPTIMAL our Joining and exciting quarterly CHIASMA to on joining our will our key turn call exciting update Senior highlight. and results;

address as met we primary First, trial, agreement the Phase in XXXX. this the a pivotal clinical Protocol from endpoint under It that Special the which to important secondary concerns X FDA results Assessment our with that positive as OPTIMAL announced recently we conducted endpoints. top line the in well agency is all note its to III raised order trial

which the ongoing commercial to is through Mycapssa Mycapssa in the we the half our us raised of is in of EU line successfully expected OPTIMAL of and following data Phase of data approval we in planned positions Second, second trial to approval the the obtained III capital MPOWERED our relief execute U.S., top the designed if and XXXX. that completion believe is support launch planned acromegaly

target the a step U.S. Mycapssa The acromegaly indications, an $X.X as SSA, we We for all now to to Mycapssa, market positioned growth we annual global planning approximately million global our platform beyond attractive is technology first for for is opportunity we well believe third, acromegaly. for with with global our plan And believe $XXX market acromegaly. Mycapssa TPE beyond for there the begin And and estimated annually. are billion opportunity

SSAs the some add considered me the other the acromegaly pain significant need well-documented for symptom Let inadequate patients including to therapy They and at significant burdens, are points monthly for injection both terms are in days, surgery. injection for and control gold-standard which Injectable site, X not cured and of site highlighted. reactions, inconvenience, injections. the treatment I several context who by lasts travel acromegaly have currently schedule of

study the randomized injectable-only a the the patient into completed these strong preference elected an continue of XX% patients to us patients OPTIMAL provide Here, adult with patients that it the meaningful confidence clinically potentially statistically Mycapssa significant you we that believe many CHIASMA injections. address extension. to arm the open-label treatment OPTIMAL is results Mycapssa, on for believe on trial XX% could the results, option particular, walks of through as burdens in of acromegaly that in Mycapssa In Bill trial in are to the speaks We and important the to an that oral this and note of the market. treatment

disruptive be and of agent if standard a we on SSAs. Mycapssa new patients for adult believe a Thus, positive provide approved, will care maintained

acromegaly to commercial sales U.S. in XX% to we small hand, of believe infrastructure. build targeting With a the the ourselves If fewer we are market X,XXX organization specialty our we approve, approximately can OPTIMAL rapidly data patients. orphan positive than plan moving we now with endocrinology SSA-treated and By in force. accounts, Mycapssa reach

is that is target our on The prior we oral key very have here site many who and identified. injectables. plan to eliminate with investments burdens with preferred patients other existing injection treatment point plan launches XXXX approved, efficient launch treatment positioned be patients can a are planned to option is our the pain and and in afford population, we if identifiable the This here to with We believe capital. unlike will launch rare-disease that we SSAs. to need line many acromegaly of and to injection leading a bottom The readily I relatively patient already where want make our treatment reactions be is is targeted

U.S. for X-month an with PDUFA-review in parallel of advance our the MPOWERED III the in commercial opportunity previously, with access trial commercial EU and completed will indicated we in window, or year, we NDA Enrollment regulatory Phase As we approvals. positive, if to approval have end expect and plan the which, mid-XXXX. attractive In to this continue second the potential our U.S. in by we a regulatory preparations, trial the either and decision second MPOWERED, Mycapssa support other in markets EU anticipated submit an condition PDUFA an that quarter. was to and

profile statistically TPE expect with is Lastly, where for and under compelling results we the we future FDA potential conducted octreotide indications, a agreement capsules, FDA. growth The well-defined a a trial in for market under have acromegaly. position rigorous a commercially acromegaly summary, patient we to attractive well consideration In for product well-run, population. market believe the platform an beyond significant meaningful demonstrated us our

in for guiding future with treatment lay into a to foundation of now look in on transitions the are new planned financed successful the will as we it company launch a growth launch support execute If and We successful U.S. acromegaly. approved, to of standard Mycapssa to I planning acromegaly. our forward to believe maintenance a well begins care the become adults beyond acromegaly.

acromegaly. adult the that, turn results treatment to with Bill? trial call to maintenance With the Ludlam patients exciting OPTIMAL from Bill over the recap I will the for of

Bill Ludlam

the Phase Mycapssa. The the placebo-controlled with Mycapssa, of their end trial trial treated the trial was of X. agreement. turn which progress placebo-treated endpoint of of randomized, Please patients minimum compared SPA primary XX to III OPTIMAL at Raj. response double-blind, was proportion U.S. Thanks, from The The maintained X-month patients XX% CHIASMA XX% a who X-month biochemical Slide were exceeded patients, which trial the to the period. the enrolled

less IGF-X there or a completed were as All to X.Xx result, limit the and of Patients data. were defined of primary missing placebo, group, subjects randomized end equal one-to-one versus of study, into the primary XX-week as the treatment the XX-week was endpoint and no the trial proportion each Mycapssa study arm placebo the Mycapssa The normal. at of upper than the endpoint arm. trial responders in the

were characteristics well baseline X between Importantly, groups. the balanced

to Slide turn Please X.

the We IGF-X primary that the of are of at trial proportion who XX% Response very upper statistically the to of maintained or IGF-X met X.XXX. pleased study; the placebo p-value a the limit of weeks XX, in defined of less end patients in level Mycapssa the met criteria with the X.Xx than significant as response the group was average the group the normal. XX% to equal response report XX and and endpoint,

endpoints. hierarchical were In important X secondary addition, there

turn Please X. Slide to

XX% versus patients GH in XX% p-value endpoint a GH group, responders level at secondary growth placebo of mill. of hormone Mycapssa the screening, a the below of with of on their nanograms study per The as maintained at statistically less defined X.XXX. response defined first than threshold significant growth X.X end hormone was the

X. turn Please Slide to

The time of IGF-X greater second equal X.X and upper of for to response endpoints greater third secondary and the are loss respectively. limit or than X.Xx to normal,

response was of both median placebo-treated median the for time endpoints XX for X.XXX. weeks, These not loss was the For response study to p-values loss by group, criteria. Mycapssa-treated than group, to end the both of IGF-X less significant of statistically reached the while the the had of time

X Slide patients secondary requiring The with to Mycapssa treatment any of on with a the significant proportion of X.XXX. study endpoint medication placebo, throughout patients Please XX% injectable X. comparing somatostatin to fourth groups. XX% of turn statistically versus of switched the with time p-value rescue treated rescue medication analogs was patients the

Please X. turn Slide to

randomized this open-label phase. patients to safety of the that those were Mycapssa well were compelling XX-week safe no new and signals or of of Mycapssa-treated As to XX% Raj appeared and from indicated, and that the one on findings unexpected be arm is the Mycapssa, patients enter the tolerated, the study observed. study extension more completed to XX% elected

MPOWERED, Turning receptor on of active patients This Agency. now the octreotide Slide responder Mycapssa patients a Mycapssa The is or being randomized to phase protocol LAR. designed X, pursuant of our to MPOWERED is prior approval of that X-month injectable to which ligands, adult run Medicines open-label, on randomized acromegaly accepted to XXX somatostatin a trial either either protocol are per second randomized phase, a depot EU. for return trial remain Phase where trial III global control control trial by lanreotide in European illustrated the consists is regulatory by X-month capsules or followed run-in a

Mycapssa The endpoint further findings a the study data in top Raj the make injectable MPOWERED that expect half be potentially with and in study key and product findings MPOWERED is The If complementary strengthen to This their Mycapssa is patient-reported submission the who indicated, here I treated proportion of to we profile positive, this of continue trial. planned progressing as maintain XXXX. outcomes biochemical about would patients the could report CHIASMA patients MAA support treated patients and compared from for like data XXXX. the response second OPTIMAL planned, as SSAs. from this from Mycapssa point to in to to line primary with may to is trial as the from

the Fitzpatrick to financial Mark turn over like provide I'd update. Now a call to to

Mark Fitzpatrick

In PDUFA of beyond million Bill. offering million. stock a and follow-on further and offering the July, into stock, which In U.S. our proceeds this half $XX.X XX. closed cash raised of lengthened raised we the raised top Slide public Please release mid-XXXX date which of $XX.X into in turn late our common line funds approximately expected net data offering common planned our and that XXXX from sheet extended runway you, a planned our net XXXX. balance MPOWERED well proceeds to strengthened of completed runway launch. our our commercial second of we second in the anticipated Thank through trial The follow-on approximately April, of

Research for partially manufacturing and offset costs. by costs June XX, financial fees, XXXX. The for our service offset current Turning $X.X compared were $X.X results a now expenses the by decrease in costs. to the June with for XXXX, million ended period trial with XX, was clinical The increased primarily same quarter results. million compared were the were $X.X of reduction ended include XXXX. $X.X which in million period increase legal of same General million period development in expenses second for quarter professional an XXXX, and quarter administrative the

For June June Cash, ended and the was $X.XX marketable $X.XX compared with share basic as securities equivalents the of in with per XX, million at million cash net XX, $XX.X loss million XX, or of share basic quarter $X.X were same XXXX, million December XXXX, $XX.X compared XXXX. or $X.X XXXX. per period

Raj. will to over turn the back now I call

Raj Kannan

That Thanks, concludes Mark. our remarks.

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

Operator

now [Operator first Capital comes begin Yasmeen The Roth will Instructions] ahead. Partners. session. Please with question the We Rahimi go question-and-answer from

Yasmeen Rahimi

questions. Hi, team. Thank you for taking my

chances scenario, team, maybe or then – is had endocrinologists of second look data hear going biochemical of to me question have least utilize data? becomes very is the – and are what best-case of to shared get the I into but symptoms know going that is, if get how on improvement Mycapssa delivers? beyond one data to what of is the to the first to So is, is And label, MPOWERED path, label through the like? views it the you existing the perception with endocrinologists until the are study you the data sort the into walk symptom And label? fresh chance the the XX going And some on not educate from at the their what specifically, off the their control you available the the

Raj Kannan

A good very is Thanks, Yasmeen. Raj. questions. This

to see remind if all of free me forget, them remember if us. I I Let can X feel

the from KOLs. feedback the one first endocrinologists So was and

can was this, to I early Bill and positive. think attest feedback, the very

more unanimously, it their eager talked to fact, every approval that pleased looking wait and In were with to single the for the quite integrating almost – data, practice. were actually into KOL to forward we and

would on of clinical label our terms question In is. the I label, trial our that population say would reflect what the

the data data well XX the – would was label be the out. had our to patients So want label, validated went XX would because reflective XX inclusion And within SSA the symptoms we we the where the from symptoms, feel OPTIMAL of. the the study after so what that would study, trial to our obviously, laid include MPOWERED of very intent that include be would we study

But Hope after what your is that all So Yasmeen. in to again, included their that review that decision an gets of answers as FDA intent. the is questions, the label.

Yasmeen Rahimi

it And in of sorry, the – then the us the but remind for not MPOWERED data, not improvement? use only into get to built much timing I the that guess label, set, of maybe for label symptom the improvement utilizing is if actually MPOWERED is safety the symptom in you can into of data how the and

Raj Kannan

know, So tool itself. on that integrated as the quality-of-life we have into we you the a MPOWERED trial, have trial

cannot what say, for we can useful because complementary will put think that very would but all to OPTIMAL within also generated. think I U.S., of opportunities, data I and into to would we promote it look in follow will what their absolutely, promote what we but of, education, requirements that the medical we terms be the

Yasmeen Rahimi

Thank Raj. you, so much

Raj Kannan

You’re welcome.

Operator

Brandon question ahead. Cantor Please comes next The from Fitzgerald. with Folkes go

Brandon Folkes

thanks question. support Hi, my the the And you taking this – open-label does control But symptom us in talked elected Mycapssa the for nonresponders the some in who on symptoms on you extension? OPTIMAL color remain into give to the can how question? prior about firstly,

Bill Ludlam

Brandon. Thanks,

So the XX%. is you response the rate arm in know, the – overall Mycapssa as

the completed patients However, oral. XX% of on

see around, really And what in positive practice. overall they stay that is XX there that reflection been the suggesting on as so that patient in don't clinical variability one staying oral, way is on you has would out these clinical are experience the what treatment. all I to and experience what of see and experience, think the It's in overall is And bounce forget, trial. IGF-Xs, becomes fact clinician the patients experience to a week a their this their the

Brandon Folkes

response commercial people they response a perspective, do at shared the post oral, that who the focused on have look actually people from higher what with, you rate the they has on data, reflection And XX% Are Okay. their the it been? of number or remained rate?

Raj Kannan

in at the the of do for many how the as So did would clinical actually will average implications know, at an would of we artifact do XX patient feedback the biochemical we real the few and looking the world, range would within the take at criteria, noted before, are look that that doctors which as world, time week is and binary patients X.X an time to at consider XX% certain they look point XX. is of in level study been they that, marker the conducted strictly as very has what a early at how points week a physicians they a of control we That's a remain in of what real biochemical trial, with look not strict at control. you In look various fashion, the they within. but

Brandon Folkes

apologize you I I us midyear? finishing – that how with a were was And time help you call. after to the could up commercial now past, launch? you about may, But ready if to did I ready build more, given the time could frame, and approval be Raj, be one if you in could this, approval, launch, quickly think Maybe cover

Raj Kannan

hands So get our X. drug patients by of into quarter is the to intent

June, in would that's of the roughly the get approval and off. July – the we kicks before the that's in fourth hope from marketplace that would quarter we August, time out So and drug

Brandon Folkes

much you. Great, on this everything thanks and quarter. congratulations so Thank

Raj Kannan

welcome. You’re

Operator

H.C. comes question Douglas Please Wainwright. from ahead. with The go next Tsao

Douglas Tsao

good taking Thanks for afternoon. Hi, questions. the

have patients eventually that Were were or – response IGF would just the you sort will Meaning, Bill, what have at X.X, percentage terms say XX% kept be levels? of curious say, to certain of would measuring been, will rate? – present able OPTIMAL. you in you of Just cut-off if had you

Bill Ludlam

So Doug. great question,

continuing So data. analyze we are to

look quite at practice, be and will see the the on and a interesting the how view We to details the the lens to of all will making be it drug. and are patients patient doing these available, that in real-world and profiles

be really you X.X. the we maintenance we want – we X.X, since response not is that a would same was would because – entry match the criteria endpoint that this able something be to of of a would and do to if to terms remember, X.X that In cutoff, trial, be

Douglas Tsao

helpful. That's then the great. thinking did And Okay, Raj, mention you in about company prepared of taking sort the remarks, acromegaly. beyond

that. thought that. at response I'm just there's And of I before with sort Just revisiting we'll curious complete curious to more Mycapssa, the about any to what start neuroendocrine see approval intent an to if letter, and there's point for seek tumors know

Raj Kannan

I that the planning in we our half in stages, absolutely, indications question the both to expansion the and portfolio announce are of would hope our say, yes, XXXX. to we and first

Douglas Tsao

that would that be And will expansion be portfolio using – and Okay. Mycapssa?

Raj Kannan

so – the sort because TPE of be beyond the to our we've extending first capsules got first TPE about intent platform with starting both is Mycapssa for then now acromegaly, our to Yes, our look at think octreotide and priority, would benefits platform. validated of

We molecules TPE the to bring it leverage other form. oral will at into that be can we looking platform

Douglas Tsao

Okay, much that Thank great. you so clarity. to

Operator

Instructions] go the [Operator Brookline from Roy Capital comes Markets. Deepankar Please question next ahead. with The

Deepankar Roy

success thanks questions. trial congrats taking on Hi, for my your and

the So a OPTIMAL. questions I few had about

the dose in how many Mycapssa? from received the how of And are many the patients patients highest open placebo So label? trial

Bill Ludlam

study, top We've Let label. those study. me in We've not X-month the for open line reported answer core data reverse. the only the given on

We the XX of weeks, completed XX% the open have the went that that into said patients label.

and may patients XX% experience. of a XX XX. this not on XX, milligrams, Remember, real-world on were reflect XX% relatively the sampling dose distribution, the terms were of were and on In is small X%

Deepankar Roy

were how towards weeks? of many rescue arm for treatment the – who patients many responded to closer needed rescue how the needed of XX the those rescue, medication? And the who the end so of on them And in trial,

Bill Ludlam

there the for part and failure X X those that of on were So withdrawal were criteria. your the predefined arm, there Was patients of X for X treatment Mycapssa were rescue, required another of failures, those X Of met the treatment were that question? AEs.

Deepankar Roy

Yes. I of – last wanted end the how one was the ask were to trial to closer And them actually period? many yes. of the

Bill Ludlam

– continuing data. out So we additional we'll as to roll be

coming out. the in have data up. to publish will conferences be We opportunities coming meetings There

that, do we become point, secondaries. presented this We as have will patient top think see you'll not line the presented just timing. yet exactly to be primary the we At the data, that And profiles. I the and able the evident,

Deepankar Roy

Okay. And of one who actually rescue responded last medication rescue one how them many is like afterwards? to needed the

Bill Ludlam

– it's a being question, to We to look as able forward great that and present we to continue we Yes. analyze.

that that a be discuss. not have but will We thing presented interesting yet, to very

Deepankar Roy

Okay, thank you.

Operator

like question-and-answer conference for Kannan, remarks. closing the concludes turn Executive This I the session. back to would over to Officer, Raj Chief any

Raj Kannan

Thank you, operator.

bringing wanted highlight you, good patient that Thank our our I Her quarterly patients for tirelessly and a update from something to inspirational story we next Have extraordinary results options symptoms November. you evening. with work acromegaly. on today. from to diagnosis an conclude, all to strengthened Before to further to therapeutic with We a treatment. to at market more in opportunity look speaking I hear again even to in directly happened forward journey had her

Operator

concludes This call. conference today's

You and disconnect have your lines. for pleasant Thank a may day. you participating,

Chiasma (CHMA) 10 Aug 192019 Q2 Earnings call transcript