ZSAN - Earnings call transcript Q1 2018

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Operator

Good afternoon. And thank you all for joining Zosano’s First Quarter Financial Results and Operating Update Conference Call. At this time, all participants are in a listen-only mode.

Following management’s remarks, we will hold a brief question-and-answer session and at that time the lines will be opened for you. I would now like to turn the call over to Ms. Director Controller. Senior [ph], Isaac and Corporate Carol Please go ahead.

Unidentified Company Representative

replay of Zosano’s financial Today's XXXX, results website being afternoon and will the and hours press after operational as Relations, available quarter quarter press to welcome highlights results milestones financial call. site a Good our well available recorded of XXXX. is call on Web and as Investor June our March through achieved be at are after first update will Today's close. on Copies release our section quarter our important www.zosanopharma.com. our the ended focus and shortly webcast available XX, of and release call XX, the our on call, three conference of approximately

is Medical the Chief Vice President on call Walker, and Lewis, Pete Zosano Dr. Affairs. Director and from today Schmidt, our John Hayley me Senior of Senior Officer Executive Joining Operations;

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

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

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

John Walker

our Thank you and those you, thank to joining Carol, call today.

the our XXXX. with trial General as and in manufacturing tax required we January administrative CMC planned in $X.X to special shareholders legal attributable with expenses. NDA compared million $X.X quarter for diluted for As diluted $X on had primarily and were increase for million as The noted scaling quarter share This first $X.X some with Zosano share and quarter to been quarter same the the a million primarily or the long same first net costs basis. loss for support. XXXX. and increase of $X.X XXXX as clinical was for in million in have basic for and of increase were compares increases of study, a same well up with XXXX. expenses this loss in on was for expenses Research $X.XX attributable million or This we basis addition, quarter a the development reported per $X.X quarter in in keeping first meeting of XXXX XX-Q, safety XXXX our compares million of a net $X.XX per the an filing in term and the basic

$X.X of March completion of generated of approximately we the April As public XX, raise end announced and million of the credit Zosano offering of a million. equivalents XXXX $X.X balance that In of stock forma cash stock would $X XXXX, and common million and outstanding. million at as proceeds in cash shares debt pro capital noted giving aggregate common cash equal to net of quarter million, $XX.X our XX-Q $XX.X had

well study the drug. April. goal subjects In in patient the Zosano November reported with relief Triptans serious post for two Both of compare as and treated migraines elect this freedom additional an patients study favorably observed success that for hours migraines. as average Therapeutic our now XXXX these that over results have are company drug safety common at events Also XX most registered closing indication we patent to Study addition subjects per in at application of Headache patent MXXX adverse offering meeting in the I in in clinical may who after are commissions Treatment have at MXXX Method meetings the in discounts, studies depending to Society in please am cash $X recently, long-term received Conference report an provides week our its on resulted patients, as first pursue XXXX of cluster of pleased both proceeds dosing. the to financial current period, was six-week XXX data company. American at and at a were of at pivotal of for to the year migraine. March has and now announced notice reached public the of reported quarter. study received Zosano of XXX,XXX. through of Zosano we price of International the initial March enrolled qualified Migraines Headache XXXth XXXX expenses our pain of meeting Academy American treat estimated the net have offering announced and of in in to and are the our number our XXX. treating availability April, no both our following MXXX underwriting XXXX, of shares allowance is very XX% $XX.X over accomplishments initial announced is our of issuance in presented stock from Zosano Cephalagia Neurology Rapidly Concentrations the reported timelines new headaches. hours last two in that to treatment the Achieving the the by at importantly, who deducting that we since and share. of scores latter as U.S. pain at of and for of through for payable the performance, indication whether as migraines and and offering XX other titled This by this In per protection million XX% XXXX, additional million

as of the our is of in keeping with plan stated registration batches in turn started and XXXX one filing. Q&As. have stability have of on to operator; a stability our like over it and for I’d our these the third for We manufacture now goals XX-month gating NDA our prepared to our this item is data for year. this remarks quarter That concludes

Operator

of question please. Hazlett BTIG, the [Operator your line from from comes Instructions] question Our first Bert

Bert Hazlett

you’re of you I’ve remind update. Yes. any that pursuing thank you the or with one John, publications for or upcoming MXXX? us got data presentations two. Could

John Walker

who I’ll Bert, of Peter that. is Affairs Smith, answer Dr. the Head ask to Yes. Medical Group

Peter Smith

afternoon. good Hi,

the American Society Headache published bothersome journal of article examining upcoming of symptom be the headache, to the in most use have our We endpoint.

that Francisco hit AHS then expect day posters We San as any to process the And upcoming have two meeting now. will… posters every at in The we'll well.

Bert Hazlett

Terrific.

Peter Smith

you can the details want as on you give I posters Do some. well? Sorry.

Bert Hazlett

That would be great, thank you.

Peter Smith

sumatriptan. So and pivotal the one to on sustain going kinetics differences pain relief we gone pre-clinical compared in on one interesting study. on specifically poster focus freedom to And will found receptor the zolmitriptan is there We've is focus the a pain trial. our other some of

Bert Hazlett

Thank color. for additional Okay. you that

Peter Smith

Sure.

Bert Hazlett

with Then to some some the mention other any John, with of ongoing and regard guiding engaged what could been describe manufacturing the in to there? the work efforts you you've are that that of items maybe regard you

John Walker

to where types I'm regard terms different general registration so and we of is that, the Hayley our this who of to prospective of the manufacturing the just for are some ask Vice process of give interest manufacture continuing to our on. Lewis well going President Senior a subassemblies as to on update as with Yes. you Operations back answer in

Hayley Lewis

Hi. Yes.

to form the So they develop batches point the NDA. basis able operations to we we've been manufacture of and registration that an were to able

that We you've identify determined our at same been manufacturing. could phases will process that should to commercial our and take process us for then take and that on proposed scattered able stable And that indeed are largest registration that that. a our scale be process you for manufactures potential commercial for there in

Bert Hazlett

additional potential you describe efforts technology very the partners more you additional thank – to partners engage And much. Okay, underway John with third, broadly. could ADAM to maybe regard then

John Walker

for Thanks Yes. that.

have were we a significant with with As molecules. a when road number I that show, investors and in to our my other we indications visiting really during platform use ADAM other indicated the of opportunity belief

in is the And more this head be of variety fold. thrust a have well a experience little there so different identify of doing a the of several time has of one to who of as we development, in scientific And underway point new the efforts business at as someone deals. will types background, bit

that in research presenting to data antigen of with the very the the good for be will example believe particularly increased vaccines, antibody And that the large others dermis, some that outcomes. our companies, regard dermis. delivery be where evidence improving generated as microneedle in the technology you measure speaking a we of due company, our that to clear has vaccine we titer an by cells as been applicable with through engaged within First the in involved get a is would of number in clinical antigen well

those opportunities for other that, fully, that regarding as to life for our regard proprietary clinical addition want cycle We in that outcomes using to could intend placing enhanced additional extension partner an take in companies do we for much protection believe provide additional of to patent a represent to way methodology that we this with their this as extension in several Zosano. by on an by do In market. to to both And been companies of types molecule we in preferential outreach explore portfolio addition and more meeting platform approached lastly, delivery. have more the delivery

can these of we a that what believe as the but we feel strategies profitably is way to areas of non-dilutive we pursue So that company. a sources number one to clearly we company for for and develop the the capital have opportunities important of pursue

business So that finance equity to it’s our we’re not totally operations. and capital, reliant a on way

Bert Hazlett

you I more forward to And on for that. Thank Okay. one guess will development. just brief one XXX that I look specifically.

the in with long-term and that terms matching saw scores relief of As data you see augmented positioning even pivotal in altered market and reinforced migraine Has the scores the – safety roll in XXX study. the what you or in positioning see the potential it or migraine exceeding – itself. freedom pain pain the the of as market or you the

John Walker

that that than is data our continue the others do triptans that that if I data fully the market with say further MXXX my suggest as And we that your That this this we how only for from best of migraines. date a don’t feel treating believe alter further producing segment I for know that position to the would “best comment strength further our the the going perspective current we it’s we being that and performance I’ve to reported largest closing I better was multiply us certainly the response made we good solidify of market. per we approved believe And going our That I this have way to is substantially migraine represent market. triptan. comment. best believe $XXX previously our address opportunity clinical view will the for in to that outcome the that to million to believe a address standpoint. they represents triptan” comment developed can the believe question, the find in and year a market which very

any between the at by end two for at freedom their which active, difference studies. freedom guideline XX.X% Our currently in group or pain use per is which most these bothersome in therapeutic XX% and the clinical other in and two MXXX for new of are product, therapeutic in gain FDA reported symptoms placebo-control hours gain, the best points the the hours words is program

with at very of are Triptan that delivery. regard to the mechanisms that we new certainly scores. in we that importantly, So the via data favorably that know scores being we developed. compete we previously labels forms pain we is least are relief pain We the that attractive, know believe with very of were for deliver comparison deliver approved that in relief of those other And vaccine that drugs

Bert Hazlett

Well, and to more comments terrific. Thank you. forward look you progress. now for the we Thank

John Walker

much. Thanks very

Operator

I'd [Operator you. the to for this Instructions] have the any conclude does management And back remarks. program like further Thank question-and-answer session. to

John Walker

Great. Well, to intended to gain really under FDA had guidelines. how already I do the data comments, that compares that others, see you. those of that that Thank related I provided to some and reported we the have include therapeutic

to So our from our execute quarter NDA file for drive Zosano perspective, in of the well an continues extremely MXXX to in XXXX. fourth

sufferers, our MXXX to data clinical and by ability the its continue approved on and to efforts offer financial We both markets of if clinical are also FDA. educating the focused the relief to migraine on compelling

in significant progress and MXXX the opportunity that suggest you along front our the call we the Thank us, again outcomes much. our continue MXXX financial markets we in follow in clinical So as this awareness in produce. as appreciate to of recognize hope with regard can will to strength upside and and the continued in your critical you data of clinical participation to very

Operator

the you gentlemen, This you. your in conference. concludes thank participation for program. Thank and Ladies today’s

You disconnect. now day. Good may

Zosano Pharma (ZSANQ) 15 May 182018 Q1 Earnings call transcript