CHMA - Earnings call transcript Q1 2019

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Operator

Ladies and gentlemen, greetings and welcome to the Chiasma Inc.

First Quarter 2019 Earnings Conference Call. [Operator Instructions] As a reminder, this program is being recorded. It is my pleasure to introduce your host, Glenn Garmont, of LifeSci Advisors. Thank you.

begin. may You

Glenn Garmont

Good Quarter operator. welcome the to Thank Financial afternoon, and First XXXX Call. Operating Chiasma you, and Results Conference

begin, development release of of anticipated be will capsules, our events but today, these of with update information detailed disclaims as XX, filed in data Form timing forward-looking otherwise. octreotide result limited we of new Mark Actual to on Executive Officer, based XXXX, call regulatory approval XX-K not regarding due or information, SEC the whether events the about including, any and and risks and as turn obligation ended Chief and over making may and statements future I in our to a States factors forward-looking Fitzpatrick. to, on statements with subsequent materially in clinical European are statements our SEC. Mark? expectations. December expectations the United well like statements section circumstances, seek Before President Chiasma filings Chiasma's certain cash the to we to our to These for regulatory plans now risk submissions, and of results those contained And the our differ as uncertainties, current runway. the year Union would numerous including

Mark Fitzpatrick

a we data company. release since and to call the This is our approach important begin afternoon. XXXX, this our of on progress excited Glenn. you, stage to our an as update everyone, thank we Phase And conference quarterly joining Thank III transition preparation clinical to anticipated update call commercial for you, first and share are

will Finance is Affairs, our progress; Administration, Development and of who today Enamait, review President Clinical our who of Senior and me financials. VP our Ludlum, Drew and clinical will our Medical Vice Bill discuss Joining

will call open prepared for Following the we questions. our remarks,

from this agreement, agreement, the line year. from candidate, capsule's release Phase positive, our a trial the the classification by our developing resubmit this with which suffering approaching X-month octreotide a our conducting anticipate FDA are our Protocol acromegaly. SPA we company, is OPTIMAL FDA in or we which treatment maintenance clinical top approval for are the of of trial, If product the III under we end Assessment review reached We CHIASMA plan Special then which milestone are a data anticipated We of results ongoing to are PDUFA and possible oral NDA for mid-XXXX. would adult of of potentially transformational investigational international

IGF-X. story, hand, tongue pituitary is have problems acromegaly the if The the premature million, of untreated can XXXX For suppress organs. be cured growth are us the surgery left those rare that altered not the remove that to to since an cases features, benign successfully hormone. long may Common and feet, death. a tumor a and with the debilitating estimate internal treatment new of and production SSAs. caused per analogs, prevalence to XX tumor. gland in this hormone, treated epidemiology is vision enlargement adults in studies of disease injections or currently diagnosed leads suggesting Multiple acting by pain, estimated We estimate joint The headache, Patients XX,XXX who intense who of these but population typically are impaired somatostatin approximately individuals. of reduce acromegaly and significant that of of for these release patients the to excessive facial led growth the acromegaly health disorder lead features of United causes size approximately is include XX,XXX a initial by somatostatin injectable of with patient that treated of with the analog the worldwide monthly, are reside surgery X,XXX States standard approximately care acromegaly an pituitary lifelong, to long-acting usually or to

conference if an which global acromegaly named annually, oral market the first injectable-only for these conditionally treatment pain to significant for be have need a by unmet by at Union. being injections both in significant to patients, estimate the important symptom European treatment in the could and mid-XXXX. findings in treatment and somatostatin of ongoing need in is U.S. of would we approved travel trade and site our MYCAPSSA We the we we both in SSAs ENDO and capture injection posters injectable the challenges analog the site clinical achieve to controlled Chiasma monthly the We of market. XXXX significant market inconvenience of FDA to in acromegaly the the biochemically particularly and However, and receive for injection the OPTIMAL and the well-documented commercialization capsules, filing in acromegaly octreotide excess If significant U.S. If treatment schedule detailing of these MYCAPSSA somatostatin we monthly presented including cycle, positioned injectable injection milestone, MYCAPSSA, approved burdens. have reactions of other to this be the inadequate injections. terms believe the March, experienced patients. analog, we SSAs data approved, million toward highlight control XXXX percentage end the well be regulatory may $XXX of In be the despite on X believe

Chiasma preparations for the commercial Given U.S. are following we timing, this readiness activity OPTIMAL data. beginning

to expect 'XX somatostatin is force. in patients. commercialize filing. we high-volume pituitary using endocrinologists If to plan to we By and referral targeting community NDA the we MYCAPSSA treated regional with of connection in able of planning to original was our XX% reach analog launch centers, approved, adult a believe and developed refer be that centers, in We specialty the U.S. much the acromegaly commercial small XXXX sales and approximately endocrinologists, can strategy

Bill discuss to call turn Now our over clinical the activity. to I would development like to

William Ludlam

double-blind, this MYCAPSSA. line octreotide Chiasma period. address approval open-label, are second trial is that In up quarter October during of on XX European for Phase randomized, On NDA acromegaly responder who adult an reached further the of plan protocol trial designed of by patients under MYCAPSSA. trial. complete gain received prior October octreotide trial U.S. planned, with phase trial running OPTIMAL receptor XXXX. support In reporting trial, the Chiasma either a somatostatin anticipate who we completed capsules placebo-controlled, in phase octreotide placebo-treated MPOWERED. treated III with This and of year. effort patients compared the primary a additional we If This randomized the randomizing into minimum quarter. August trial trial trial the X-month Agency. from The outcome to the the reached the is SSA. is enrollment we are adult is consists trial, XX X-month the either treated to depot responder at X-month positive, with a response being XXXX, capsules endpoint year, accepted the X-month is end randomized a also Chiasma patient by we OPTIMAL octreotide FDA biochemical that enrolling patients as The are designed endpoint octreotide in global, treated MYCAPSSA and an data Medicines enrollment Thanks, trial a expected remain that compared of patient as proportion The the X-month acromegaly MPOWERED XXXX, an In patients after a MYCAPSSA and completed this regulatory their is the concerns to will to raised one-to-one biochemical capsules investigator basis, response EU. with MPOWERED, EMA-required experience controlled maintain announced or running patients to planned enroll of agreement assessment in special X, patients where to third XXXX, of trial we with maintain currently to a to as Mark. review the The return anticipate be this or conducting the anticipate capsules protocol ligand, In further trial OPTIMAL LAR. injectable by patients of response The letter MYCAPSSA efficacy followed patients top active with we to under injectable Phase patients parallel, phase with randomized is reported The a trial, XXX Chiasma the in progressing XX classification. to the their and progressing end we we evaluating versus the which lanreotide, is of randomized, of in in III from patients U.S. a X-month Phase the proportion controlled XXX November, we of up in in on PDUFA patients U.S. the primary April MYCAPSSA our OPTIMAL resubmission ongoing III we placebo.

treatment. We in continue MPOWERED tertiary injections from secondary to to are options treatment of or data submission administered and the the the they If as top are of could positive, planned cost report similar from typically support XXXX. line XXXX. MPOWERED EU guidelines in a in in the and expect are total U.S., add Acromegaly hospitals, in which second to data MAA half

Now update. provide to Enamait to financial call over to like I would a turn the Drew

Drew Enamait

this approximately line common stock, The our extend offering top $XX.X if follow-on of runway release proceeds late In including through anticipated PDUFA closed in our we Bill. and net mid-XXXX Thanks, XXXX, the April, to data public OPTIMAL raised Chiasma offering of of raised the positive million. date. into funds which

XXXX. ended primarily XXXX, include legal of compared compared current administrative first period was and were quarter for increase quarter million our The results, in million professional offset $X.X in fee, XX, an ended expenses reduction services for in increased same due for million with expenses manufacturing-related to the development same increase general a period the March XXXX. The XX, quarter the XXXX, results with March by XXXX. which of were to Turning costs Research the were primarily costs. $X.X $X.X million period $X.X for

$X net or Cash, per period XX, For Mark. in the call I and were XX, compared basic March back was cash loss same $XX.X over XX, the will XXXX, turn per share to the equivalents with at or March December as now XXXX. of securities marketable compared $X.X million XXXX. $X.XX ended $X.XX share of basic quarter XXXX, with million $XX.X million million

Mark Fitzpatrick

Thanks, our Drew. concludes prepared That remarks.

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

Operator

Instructions] the Cantor Brandon first from of [Operator line Folkes Fitzgerald. with Our comes question

Brandon Folkes

want like have to market the of about think these Given sort look new talk of will you the how the first mentioned rate first and you see you acromegaly market what awareness wave the attractiveness if - market increased treatment, you apologies then think And that bring that tailwind a when of physicians response of few this market? that may help but companies to to to started you you the are of on the MYCAPSSA call, recently do in readout? you MYCAPSSA potentially do

Mark Fitzpatrick

question. very Okay. Brandon, you your Mark. is much this Thank for

increased So the well around Clinetix II getting there. to like, a and that part is you're as that awareness seem earlier acromegaly that question that trends market market be We that Phase players certainly the with of number year does just feel of seem this first fair given advent same the be amount the active the to of there initiating activity. of the

able data will we will several of that information And the must with been fair our of if at been XXXX ENDO launch XXXX approved. product, and there our believe posters there additional amount conferences connection certainly XXXX where our in a we and product to others feature significant amount be that and have XXXX. as ENDO additional prepare is other since like presented We to it's in conferences do in a

response the placebo-control like we and is between outset designed of up the from question, XX%. of the your trial, arm. terms MYCAPSSA to built trial And whether the arm I to placebo such believe active the a that is that and relation as XX% placebo in think the determine the something we've has response you response second there rate, delta in know, been in as trial to design said rate is response

positive in calls their equate rate when Phase were would we others render rate on XX% And mind III was perhaps of even hosted to able some for with that XX% response a MYCAPSSA-treated delta patients. a positive trial, to that a a be that a deemed first were lower patient prescription In a on speaking XX% prescription a to a recent and we the or would response response in so patients. for rate in And idea KILs by that decision demonstrate area decision polled, still product ours. like physicians likely know physician

Operator

question next from the Roth of from comes Our Capital line Partners. Yasmeen Rahimi

Yasmeen Rahimi

levels can like for the What placebo analysis? response that would one, once And is, want patients walk with to before continued point that your I on what follow questions cutoff through are and have that are you Congrats these progress. do you to placebo occurs, in of the IGF mean me come in rescue? perform OPTIMAL rescue? Question see on you do what counted I you - then patients' towards you a the And a Two you. up.

Mark Fitzpatrick

Yas, your line Thank to with for Bill question who is on Okay. Bill? I'm you, to refer question. going Dr. us the that today. Lublin,

William Ludlam

Thanks, Mark. Yasmeen. Thanks,

for least have symptoms the the they've the withdrawal are upper or are patients they at number of they criteria pills, with At limit X that is weeks. elevated day have consecutive withdrawal on predefined highest follows: the as that nonresponders. are along pills met met X.Xx IGF-X, and patients to And considered that and point, So go X X of eligible withdraw. predefined per At normal X greater the point symptoms, that to - have point, they're criteria, binary that clinical IGF-X. IGF-X at

patients. typically will they withdrawal into that they eligible be considered define nonresponders open-label If criteria, the to from nonresponse of but it's forward. go So they're point the these

Yasmeen Rahimi

What we study? And helpful. design you that have very the have enlighten previously bit of me question little Bill, is That's less element kind should then more. we maybe also, that a ensure trial seen with the of for dropouts XX to

William Ludlam

Yes. Great question.

We a resolve learned that had simply always will meetings really for is really learnings that that, important there staying emphasized we the least signing really escalation first measures dose that would is to up we on. do median encouraged These go back where to what that that with penalty sort that going side with up drug, carefully duration and with maximize between really effects resolve the included in there we example, on these rapid these the are - We've from have again, And first trial, say is, is class going patients can the learned certainly back no study GI chance that and the And work studies injections. So understand a are escalation. the after is we - then any conservative the they I if and convey there's in a but no clinicians that treat choose importance several to things. for you third patients dose. of time and clear think that patients on often investigators several there full investigators AEs. we dose at in we effect that piece patients they they're the investigator that a in their XX% There's looking correlation as XX increase XXdays, trial. patients so talked that at that their data for through of that. that I One

treated patient exposed state. lead to disease However, going slow, the potentially too and under you their by

So we week Again, stay study, all things the stay believe those by be in be until on going we they'll half collecting are rescue together, at the the putting but least maximizing we're patients that will to data chances presume of XX. we'll going the in study. to medications, that successfully

Yasmeen Rahimi

How despite of in question. of last that biochemical you're may focused one terms I aware that segment if is the a managing a on? much symptom And very market burden ask are And physicians control?

Mark Fitzpatrick

as meeting Orleans. Pituitary meeting Pituitary Society New in presentations poster featured discuss Yasmeen, Society ENDO So as that society this year with or well in the to was the

control are symptom issue under quality biochemical life physician So the suffering with and I awareness still be of that patients think like. control that the can that

to even has I suffer think the a that, as and learning fact patients over to that of continue awareness couple do from the control. it taken years, - to to seems place the last be biochemical real be condition to heightened under that us

Operator

comes from Kumar Markets. next of Raja line Our Brookline Capital question is the from

Kumaraguru Raja

treatment to from on So well inadequate the control dissatisfaction. as showed where you focus as there's I poster wanted that

know addressed Is in this patients? mostly or reconstitution for the as label the education driving is or to the challenges wanted the I And physicians So effort as highlighted depots? well somatostatin the this. of how with what be it injectable and can

Mark Fitzpatrick

Kumar, for thanks your question.

question, able perhaps not the label expand to on and has the question, first discuss - we're - going of is be today. is Bill for that to something I But going can part how second which to could symptoms, we comments, speaking which the to of part Bill, Kumar. think with you that do to the the to posters I certainly, think I'm go the

William Ludlam

that half granularity after Certainly, was understand what of were - analog injection the approximately wear So of some patients come cover toward asked causing on period end injections reaction, additional sometimes to were the the site drug, the injections, that symptoms off issues. complain about it trying requiring specifically the of therapies early-on the the the of questions we last that to that didn't month, the somatostatin of time. some active towards get immediately of injections to symptoms

despite the collectively, is these with burden, the So somatostatin and add believe things therapy. to with analog contributing overall certainly, to an issues satisfaction injections we

Kumaraguru Raja

resubmission? time for be following Okay. And efforts data, like, would being what final what line and one the at time the those? made question, for are And steps NDA that

Mark Fitzpatrick

the is So we the Kumar, resubmit positive in of by would if expect end to data QX, the NDA year. our

relation we an have before submitted NDA We then to - in have this product.

with goal And would analysis we then of we preparing data NDA project data, NDA end and for the the to submit pieces into to be move we that working information we filing data NDA been other by able to year. actively prepared the the go that necessary forward of have are to receive once that preparation, that submit until we our of the working on of XXXX. that have incorporate have that been before and are into those and have don't ensure elements to be document the that We and the so the end

Operator

[Operator back Instructions] We floor closing. queue. I'd have for no turn questions to management the over to further in like

Mark Fitzpatrick

want a today's and you in today. operator. of with forward myself on our Thank concludes update and Drew you. joining us for you Thank to I look quarterly We much, August. to very evening. Have behalf Bill call. you call That next very good thank

Operator

Ladies our today. does you. conclude teleconference and this Thank for gentlemen,

now lines Thank day. have this your and disconnect your may time. You for a at wonderful you participation,

Chiasma (CHMA) 12 May 192019 Q1 Earnings call transcript