ZSAN - Earnings call transcript Q2 2018

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Operator

Good afternoon and thank you all for joining Zosano's Second Quarter Financial Results and Operational 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. Carol Lizak, Senior Director and Corporate Controller. ahead. go Please

Carol Lizak

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

John Joining of me of Walker, Vice Don Development; Officer; Clinical Medical on Schmidt, President Kellerman, Dr. Affairs. the Executive call Senior is Dr. Zosano Chief Pete and Director today from

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

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

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

general the share six of million net in $X.XX second and the per turn a on diluted quarter $XX.X XX, $X.X basis $X.X compares June million financial for which and to months $X for loss are and or costs basic to XX, me and share development of months in Now and XXXX, $X.X to our for for the for periods compared for million for net XXXX. Research or million MXXX in other trial the was year-to-date. and June same basic taxes, related registration clinical and loss actual the increase end million batches results per research $X.XX to $X.X to and or of let or filing timely XXXX. million respectively, activities. expenses expenses the a $X.X our increase periods attention and study was for franchise support $X.XX and the and three same administrative on $XX development ended $X.X and General production rent, basis the June months and and quarter period quarter ended This the expenses million and diluted the general on an share share The XXXX. in corporate $X.XX per and the in increased to of long-term our six of for and million necessary were million XXXX, million XX, the basis on the six administrative the safety attributable $XX.X increase NDA due a compared per reported expenses a and were million to ended the for the in XXXX. XXXX. to second basic same basis diluted by $X.X $X.X Zosano primarily basic The diluted million

million, million price XXXX, shares outstanding. now $XX.X had after approximately net proceeds batches, XX, John shares XX million of cash, of Walker, the XX over of common per turn we accounting $X to to MXXX and million closing securities April legal debt June for of equivalents I $XX.X our a In and Zosano XXXX, registration Cash stock of $X.X due usage underwriting safety marketable will cash and were working pre-commercialization activities to offering study announced public As this long-term million call its expenses. our discounts share. and the of support of common our a production of Zosano the capital. at CEO. the and deducting offering from of manufacturing to with The

John Walker

Thank joined call you, Carol, our and thank you all today. who have

total trial months publish the per to to towards having completion to reported on freedom XX% and one and pain MXXX efficacy both at Today consistent two with the the pain efficacy over sufficient XX% at XX months. of tolerability complete of treatments of sites. Similar is relief second that seen number subjects have been complete subjects what treated course date treated of at investigators two treatment. and migraines reported XXX This We development. two well more average progress our the hours controlled was is today was of the than XXX In tolerate migraines at excellent continues hours. X,XXX an trial subjects study drug. six reported placebo has long-term and year of to XX treatment of we enrollment quarter Both safety completed trial. subject of ensure make U.S. should least subjects be with open groups continue label a enrolled with

been Additionally, drug serious there the in related trial. adverse events no have

in UCLA We Society efficacy Headache meeting as binding minutes Rapoport with new treatment inform some relief as our as of At of two XX% XX% subjects in to of the within many we efforts trial as post XX our data well hours zolmitriptan. the to data and experienced than American Dr. showing additional continue clinical greater receptor at San of post to from June, progress related reported our presented Francisco, Alan experienced pain analysis pain results. community relief XX dose. and MXXX

P the to which to duration profile Graeme onset a study XX% positive sumatriptan affinity In Journal with of Martin, group that and of two and original tolerability freedom for of most or of observed to skin part X.X tolerability and compared data of high a kinetics addition, receptors we bioavailability for from Pharmaceutical in In XXXX, skin by intracutaneous pharmacokinetics delivery. explained ADAM the in migraine and of of zolmitriptan. of In the Dr. value ZOTRIP the delivery May was data recurrence batch one migraine relatively Most ADAM's group. bothersome targets moderate the a a severe of the maybe the at our topic the efficiency the in in the XXXX, binding MBS Head bothersome publication XX%. zolmitriptan announced June hours Face the high of of XX% Science longer compared non-clinical as triptans. absolute symptom significantly zolmitriptan in placebo was of MXXX pivotal the The data presentation study presentation placebo zolmitriptan mg Headache: low XXXX, and the delivered the incidence published which XX% This X-HTXD His subjects fast Pharmaceutics of studies to of to X-HTXB developers Journal and showed Journal both compared ADAM from X.XXXX. of zolmitriptan. X.X-mg are Pain. of symptom, showed the was recurrence less a pain intensity subjects evaluating bioavailability technology In binding by the published pharmacokinetic zolmitriptan July of with using in receptor MXXX

we with Zosano contract been discussions meet In requirements. will with repeatedly our quality batches to scale three commercialization to to process in key manufacturing, our our keeping on provide to the remain organizations quarter illustrate stability areas for have testing ability in for on this progress made We we of One goal engage to our focus have our the track on manufacturing for requirements has accomplish and decision and third help our as to MXXX. a long-term manufacturing. launch registration made anticipated

to cost financing, of capital capital to May. the quarter, these our business in Elms and the was We outsource it more firm And quarter He was largest manufacturing in have decision us Aisling long in expect in our to to the to our Directors Board recent pleasure Also discussions believe his Steven in will to expertise reduce brings investor help further by end we that of M&A Capital pre-launch round. considerable report our welcome our the and to this this impact table. will positively requirements of and on term. development, goods formation, the

independent management, and of capacity. to with since Ken wealth Greathouse I marketing, new and working election has Board be in Board Directors his portfolio his the a to look lead brought general last knowledge the of to director. elected year. experience Additionally, Ken sales, the industry forward Ken

will we endpoint reporting As MXXX year the in the six-month be quarter. the the the completion we that early on safety expect of we move long-term of study for towards end,

clinical manufacturing analysis completion of plans by continue also the registration study batches will scheduled end of key as our our the meetings at third and scientific We finalize our to quarter. the to present from and data the commercial pivotal of additional efficacy and

continue Chief the We for and MXXX. Financial a developing Officer recruit intend to to also plans marketing of new

recently for increasing of provide opportunities a benefits proteins eventually to this questions. molecules. delivering I'll and our my drug that, us well with of On and U.S. of small and programs development in ALZA and of we designed predecessors open peptides for the And technology. as this with effort who Johnson this capability enhanced capability operator point, the With as obviously from Johnson the initiated to benefit of when cumulative the last turn end successfully marketing our our and vaccines, portfolio ADAM the over have comments ADAM driven to to from deliver approved clinical technology review that & is demonstrated back demonstrated platform work a provide the can to an paired Lastly, have we

Operator

first Bert question [Operator our you. BTIG. the And line of Thank comes Instructions] from from Hazlett

line now is open. Your

Robert Hazlett

for Thank all regard with you. the results to final anything of the The be then what to progress. release to study, the the - treatments you Thank be detail Could your progress the John maybe good question. number Congratulations you're that something information? at per seems describe taking there. is you you more And seeing? is would on safety press that or medical month delivered? And meeting format expect that any

John Walker

much very development turn question I'm heads going over to this work the to for clinical Don to respond. our Bert. Kellerman, up Thanks who

Donald Kellerman

of for number Right, are six to did the the so again subjects getting to a question. enrollers a enrollment, have point and aren't we completed thanks February have fairly where We're first shape. robust months

months people we'll - six So complete see thereafter. month those next October a lot of in

how terms In both. results, probably present I of the we'll think

of results that present again more We point we we've this and this meetings. medical think already future pain I efficacy than we treated level to trial. and announce in the will treated meetings, we these X,XXX level presenting data Yes, at did of in forward high plan we trial. subject that We upon see this will probably highlighted look to of the completion already some certainly that the and is haven't the pain migraines relief same of the freedom in

John Walker

this at based subject of patients average So that additional enrolled treated because I to generally the migraines compute vote $XXX little we've it subject, of in On that by that of treatments per different on had we're a color, the which a phase is under but as can can with total this three just in per you to between it's treated point in add averaging point would bit than more month have an themselves hard so times. time actually we how timing and the $XXX and tell XX get one number of time. just at week basis, we've average

at course of freedom particularly So patients report we data be within because able patients point the regard least to present study. It basis. is the that point to make conclusions complete the slim data utilization little and in forward ongoing of at application would six-month XX% I'd of least that those data to we will be be in what interim time. our continue the results probably that to will of that increased on an look of medical analysis in group able off perspective do a we pain of still a that study having XX% an at that FDA while bit XXX time that part achieving from are defined fairness are be terms open at from But who any we the would say see label moving And as one to this has will share at part the indicated meetings on are Don able under as and an on as MXXX. to

Robert Hazlett

you're general - color. construction that general terms goals like that And just manufacturing you side on the what outsourcing? in sounds with then are with the - discussions in Thank just things. Okay. the under it manufacturing of you Could terms the for

John Walker

to you had would went as et moved manufacturing cetera subcontractor our pads into that the adhesive, we know but year recall, as own. fairness that the as are we on made component to system scaling all be being the anticipated originally parts of delivery had some up Well, that out ring by when titanium there talk does are we And this in we sub-manufacturers. you

a that would a alternative very that about conducting were And $XX coding with XXXX and in the the that of And to we is think would really the into if current the were that our handful the they'd with will time to if what different we ended it manufacturer more attractive discussions in number manufacturers to taking that we to process larger through with from and we have a folks a response based cost attractive pleased a competitive is some contract program interested have on. with a discussions we to manufacturers of and decided be for with received so, and actually and ad we sub-contractors go applicator, itself. and staying we in see was So up translate a now own our self-manufacturing we assembly capital worth patch on of million provide of that chat will be this and anticipate incurred a the major of we couple patch cost end between otherwise discussions of it on of goods the both be anticipate - that through the other have, sales. also and neighborhood million we $XX very

manufacturing equipment is to in launched so launch I And support doing of objective and put said defined we hopefully be are capacity this at adopt to now of infrastructure align to and costs. our up position approaching as processes logistics, scale. who manufacturer winding in QC the ourselves our reduce between in and QA a to some to to with manufacturers control and cost in the current here better capital the to to accept that that Once in able components able we of the time the folks process are so our be point and in for to have us

Robert Hazlett

Terrific. Thank additional color. the for you

Operator

over Thank I'd I'm no back closing like showing the questions to at call you. remarks. for the lines And Walker turn any John further time. to this phone over

John Walker

by registration to completed we're earlier very close remain to for the development had executing making saying we to track of track that third the the be the I the trial We six-month XX-month like completion with first of of the of that would for on the this pleased fourth milestones being MXXX. quarter in our early to end progress just year the point continue and elucidated on terms the we badges in on XXXX. to regards quarter of quarter in portion within stability have in

a are then the intended within data or ongoing that I'd continue to XXXX that a by the well MXXX like of and from lead the we tolerability of fourth in the of to pleased XXXX goes of NDA if as patients in also of investigators the in commentary an launch early clinical studies. filing part to of All well we with that add the to anecdotal anticipate MXXX to performance XXXX. the receiving to regard the all very be of quarter and as end market

very we additional pivotal that So decent good the have data treating triptan this to do migraines. data feel focused combination the on that with effective the of an that published be very study market in already able a continued in launch puts of analysis strength we clinical acute have of attract the us that to and share and position and currently to from presented

that, for their participation. my comments I'll with and end So thank everyone

Operator

you may have gentlemen, Ladies and participation day. for a program thank and concludes you today's This the now conference. disconnect. great your Everyone in

Zosano Pharma (ZSANQ) 9 Aug 182018 Q2 Earnings call transcript