ZSAN - Earnings call transcript Q3 2017

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Operator

Good day, ladies and gentlemen, and welcome to the Zosano Pharma Third Quarter 2017 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to Georgia Erbez, Chief Business Officer and Chief Financial Officer. begin. Please

Georgia Erbez

the replay welcome Call. Quarter on important Today's results highlights and Operational Results our milestones Zosano's XX, our and Conference will September call Press our Web-site the Update of available call of Copies release achieved available to shortly afternoon is recorded well quarter's Financial Web-site Third hours press and being section approximately financial are Webcast XXXX, November on and after Good after as ended close. Releases as the of XXXX. of quarter and our will focus on the a www.zosanopharma.com. be available Investor Today's our XX, Relations' three at through call

Walker, Clinical Executive VP Senior me Kellerman, our and Don Development Vice our Chief Hayley Joining call President is the on Lewis, of Officer; Affairs; today Medical and from Operations. our of John Zosano

that regarding outcomes future may statements that we materially. remind call risks and actual to include begin, are in beliefs differ today's and uncertainties difficult statements you predict forward-looking events. subjects expectations to and me let may are Before These management's

those therapeutic expectations projected statements development for Company's our forward-looking capitalization the Forward-looking current events, partnering the candidates to the involve our results. forward-looking These assumptions law. differ We our to These may conditions forward-looking expectations commercial statement projections materialize may the and except in materially regard any to strategy, anticipated our events could MXXX, anticipated which product or or results regarding potential not changes in such timing any the required relative our business, statements herein regarding or and in performance. competitive circumstances and therapies, approval such constitute regarding from to our financial statements. Actual expectations obligation is progress to sizes, and statements MXXX thereto research versus revise by our any markets market potential future assume our or do expectations incorrect. the or and forward-looking with and that expectations obtain and future ability change activities, on no of update of contained be of MXXX, based, our relating reflect FDA give never of statements timelines of guarantees any as of prove benefits

For a on on please call the Risk John. SEC over and business, Factors regarding XX-K refer of Form detailed of as XXXX. description XXXX, our the risks March to turn X, to now the our with section amended filed I'll X, uncertainties the March

John P. Walker

doing call foot MXXX, we to focused NDA Georgia, will addition you, and needs an I product what to important today. the thank Thank that emphasize Zosano's joining to those file we on be privilege share to are ultimately a level, a accomplishments. to done recent From singularly XX,XXX to you our our you want commercialize It's with of and be treatment believe migraines. acute a

our are manner. timely goals in cost-efficient a on both delivering and We

MXXX focus regarding data the the on community We continue program. to from educating the clinical clinical

October Management published Both Pain pivotal and in published was August efficacy I Phase Our in study by peer-reviewed data important data in journals. was our medical are Cephalagia.

other British at to on migraines Headache can Zosano treat in has of onset, clinical how the and Society data durability and delayed. been presented These to addition reported the very previously our understanding hours. in International treatment efforts efficacy to in the Columbia. faster building the pain X.Xmg showed XX MXXX reported of our and regarding address new freedom the effect dose in team in at MXXX awareness Additionally, XX XX where dosing we from are has of duration believe in There, data, that post clinical September, ability important durability of study ZOTRIP clinical need hours and effect effect, positive the XX Meeting community additional for been Vancouver, morning migraines that and response

You demonstrated and X.Xmg the are both of achieving most results met endpoints, of statistical one pain MXXX significance minutes freedom freedom freedom at the two already pain that and co-primary from dose ZOTRIP bothersome the at trial and aware, symptom reached XX hours, hour.

events a the in other no profile Additionally, as demonstrated with MXXX safety reported similar triptans trial. serious adverse

Importantly, our second major on will we repeat uses With that to complete prior conducted The patient migraine irritation study our the at observe long-term in any study first in first we executing that enrolled application selected record week our and NDA. the of XXXX. our and is Yesterday in of safety our that lead September, Company, investigator plans the NDA MXXX. submission visits we announced sites, enrolled in is clinical our half study long-term throughout local our MXXX meeting are first to the we CRO October, patients. need The to safety have of evaluating our of filing the the initiation site final XX first site now of safety in the trial to primary of purpose completed patients November.

to able we'll using be how safety, are to addition our drug a get of in In real-life glimpse a patients setting.

funds which Capital manage facility as partnering the stock how Also, and not shares balances. standby down worth facility us Zosano month period, a as entered our Park capital October, quarter's therapy approval regulatory help any we sell taken after operations. explore of up on over perspective Lincoln as us a This move this to by which agreement investments further third gain Fund to principal intend through is available million certain for to continue we purchase the subject limitations. have be the to to cash towards to To help date, we provide to strategic in $XX close means to intended will of our we used, a to them with the XX will expect MXXX into commercialization. and We be common

long-range to examine completed we planning you towards that our last You regulatory may discussed path MXXX. of and recall launch quarter process we approval with the

volume believe capability our for we can to two As first that during commercial ramp Mr. enabling to years the seasoned post-launch. scale-up said long-term operations. development value Greathouse new been once MXXX current marketing, development, is MXXX of have has pharmaceutical Board the Also, importantly, demand provides fourth business programs successfully We early of executive three of commercial the and the central we a that with to appointment Zosano portfolio in a in of investment manufacturing well, We in of production at announced Ken manufacturing anticipated before, launched. facility experience sales, years Directors. are our meet and believe plan. to many Greathouse our as quarter,

we delighted and our move We him to his add MXXX Board to to look forward market. the are contributions to as we

remains and commercialization on successful important focus of the of new migraine. this the Our approach launch for acute treatment

provides the study, capacity for the XXXX. tool a building place ask XX, data, our September and I'll a our that us long-term safety our cash We into our review and Georgia position, operational continued effectiveness. ended quarter manufacturing for the are financial third results now put initiated have backstop dissemination of clinical financial to

Georgia Erbez

the and third $X.X compared the a a G&A of quarter quarter per and MXXX. basic a you, for quarter of or trial, of the net of XXXX in of which basis, development costs for pivotal basis, share on expenses diluted the or and change XXXX same third in control the were General for of was loss expenses XXXX. initiation XXXX with million, third resources from XXXX compared were quarter million to by focus in $X.XX with the XXXX Research Zosano clinical which for net XXXX. the our of same costs $X.X reflects the and to period. efforts the XXXX XXXX. quarter period evidence completion the expenses offset and Thank to million, diluted decrease quarter XXXX development of completed reported and John. in for on unchanged, in efficacy the million $X.X and quarter $X.XX giving share administrative third for were long-term on million, third basic of each a of period loss safety related study, our partially The our for $X.X to were $X.X ZOTRIP per of increased a expenses February related

cash, As marketable XX, have equivalents the a had over repay We this outstanding. $X.X this shares term balance securities questions common quarter, XXXX, statements time. efforts million XX.X of and million, prepared our call to our million loan previous we completed and Operator, reported of of to cash and $X.X reflecting of September decrease outstanding $XX.X please the facility. we debt open million, time at a our at continued

Operator

Charles from Duncan The Instructions] [Operator question of Jaffray. first Piper is

open. now is line Your

Charles C. Duncan

the of quarter. and in on Thanks kind bit us study, long-term about the questions congrats regard for little and that you of the could the progress sizing remind of taking to and study? timelines that a With the basics safety

Donald Kellerman

Sure. to couple the topical is year the a on It's think XXX Don designed six stated The safety times This study we see months, again Kellerman. a I subjects of of for underway. we've evaluate be focused to and as XX application MXXX. nice is with for the

looking label so probably the in get really is done year. currently again, study XX first either next for we at, are also early for who But of to we're or driver a continue XXXX. were started hope a enrollment, trial. relatively And will it's it who subjects year, think open in, just in quarter participated anticipating, that A we subjects reminder So, about couple that that study the into the ZOTRIP I sites. and straightforward first second of patients XX again, participated

sign So of I good uptake. think that's a terms in

John P. Walker

can, efficacy efficacy we to sites study is in those I'll little well, is And just of the comments, the this positive secondly, we have for pleased half and participated patients study of sites inclusion that of for that I of that over are were study. couple some heartened a them sites is had that add that the the so were at Walker. a their that list that consideration and find selected, sign. that on in this XX names participated our in Charles, we had we just John as reasonably out that put also think if

And of so, in the enrollment will on from first benefit that which we XXXX. study for around meeting quarter we're the within held investigator enthusiasm completed based September hopeful and hope we some our

Charles C. Duncan

guess trial, provide be guess that's I therapy? will would within John, read Don the to pretty the and enrollment, to to Okay, any helpful, I'm as extent you persistence quick, either satisfaction wondering I incremental with or if some updates because and that I intend that

John P. Walker

one you know on we And quarter. year to will committed we will as you release Charles, be next our six-month completing endpoints, releases certainly patients is and be calls, we calls we or enrollment. continuing will during send certainly But updates do every discussing the future I to that each conduct the year of quarterly months. know data, periodic intend are we week that appropriate. we updating month think XXX don't the our to out And as on because six think every able to

our short as said, we the as are and given Don calls we give anticipate have label the fact, study safety, in we completing indicated that a feel will the study. subjects be do open should that it months you around earlier, on six we views take place is will that more doing an how As some the of onto quarterly therefore update and you think relatively the fashion, certainly

Charles C. Duncan

to to Lincoln perhaps take additional Georgia, makes transaction wants Park. let's whoever that say entered the one kind into you sense. Yes, related with question And it, of is for that or

safety you to those even capital sufficient the or perhaps assuming and all complete study get that well you pricing, If distributed have you'll that into are believe long-term shares this a assume it? do

Georgia Erbez

as is primary It certainly going not X.X really a view balance a to month It the source our possible, of Charles. is We to as or but XX capital tool this year manage life as a cash tool, instrument. the forward.

enough stock overall what to really So get conditions the are, of is the of on us it partnering is discussions amount the completion to at, price it – study. the but going the the market our the in depends certainly certainly general are and what

Charles C. Duncan

you any be us Biz actually perhaps had you is question fair it And I International have but product strategic from was I just then observed we inbound I'm does to to this know wondering candidate also philosophical seemed much, team portfolio? and whacks the interest. MXXX, that Headache one of interest frankly, amount calls, Dev at but KOL interest final of if Society and both a but migraine at say in types there and in my And in was the there – can't a here, one, associate, broader American appear you member my

John P. Walker

and the results our had first FDA after be in very announced to at Vancouver. at the June, meeting Charles, the inbound the clear, we which of back We up occurred Conference Healthcare end certainly calls, really have of of International

that team interest additional because lot his think I expressed job did a did and nice of thereafter. Don really a have we immediately

a best I for our become towards in interest provide the least as and try As stock on is hoped, by we from has trying a the the last mind. for And difficult and that. than of capital to performed call, commented strategic other capital. I anyone standpoint, wouldn't company our anything not I saying certainly at able to markets us has shareholders Being our to have our best think kid to current to would me as it keep look way

was the it one, as place Georgia additionally, to, as decision and with Lincoln good into really this a Board line so, within is discussions equity that decided aggressively. why for idea because to a Park we pursue more put we indicated, as us And strategic backstop, it a the reason made number serve does,

the discussions us is below alternative the we what they well hope into at fair capital formation strategies price and markets share frankly involved in And simply we are point all so, the of to our think we offer with value asset. this that go

Charles C. Duncan

hasn't us. we way and maybe because Yes, I performed thought would of not us in that frankly despite have the it's agree the either, stock that

for on taking So, I'll questions. the thanks and the in queue. Congrats the hop progress back

Operator

no questions for in call the Walker to are queue. turn I'll John closing remarks. back the There further over

John P. Walker

Thank and taking your listen for everyone you to our you, for thank operator, again, time questions and call. the to

back fruitful that the do reflect start Zosano inflection capital year. initiation needs pivotal we long-term We study year. data they back on XXXX that Administration into very believe announce our several indicated, follow-on efficacy we certainly was March this protocol did move to to with efficacy Food very We of and delivered pleased at for the in meeting it agreed back long-term did February. key offering filing was proud our our that of least that in this safety that safety results and One our a we've has As and Drug sufficient in provided us a points that was and sufficient. and had that only

we we way studies, a to to and calls, Administration think that Food data. preclinical division have further have test I the see addition some We we as dermal prior also, a a additional in type would have mentioned of to Drug made in on believe that know commitment and that the study do normal that prefer sensitization of volunteer

comments, in community we And to of are part that that Charles' fully gotten terms and the in the important address we point so, clinical aggressively clinical appreciate NDA. other believe this time response will have MXXX the positive And community completing of what are in some from necessary and moving addressed therapies. we we've is the file our the forward one momentum that available that and to, seen and we a needs believe that very to us the lead on at have by not product patients does attractive in regard

as Zosano Thank we that, you progress thank we our to we'll update with move appreciate again your in you on say continue you. we'll interest and So, and forward.

Operator

conference. Thank you. Ladies concludes gentlemen, this today's and

disconnect. may Good now You day, everyone.

Zosano Pharma (ZSANQ) 9 Nov 172017 Q3 Earnings call transcript