ZSAN - Earnings call transcript Q4 2018

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Operator

Good day, ladies and gentlemen, and welcome to the Zosano Pharma Inc. Fourth Quarter 2018 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 is being recorded. to Financial host Officer. like Greg today's now Chief Kitchener, would introduce for your conference I

You begin. may

Greg Kitchener

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

the Don remarks Chairman prepared Development on VP, me the is Later the with by today Chief and and Affairs; of session, Hayley call, call joined Kellerman, Walker, question-and-answer be on Lewis, for Officer. SVP Executive and Operations. Clinical Medical will John we Joining

Before today's from actual such statements call to are statements. that and we difficult to and differ expectations may risks may you in These subject beliefs. are that remind management's current forward-looking and reflecting predict include those uncertainties let anticipated outcomes materially me begin, forward-looking statements

any market and our assume statements, potential financial except expectations required strategy, law. business, our regarding of Qtrypta, Forward-looking our other activities revise to relating approval of expectations FDA the our as projection statements We -- forward-looking development timelines ability current to include, regarding therapeutic projected Qtrypta, Qtrypta, and competitive our partnering but commercial MXXX, product our relative therapies, projections expectations are and the versus and regarding not potential results. obligation or or markets our our to benefits capitalization the update by our and sizes, of of expectations limited to, no future or anticipated progress milestones, for and the and candidates obtain research

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

of the which turn few over per $X.X to in safety The cost administrative loss of study. XXXX during primarily compensation, a during $X.X full quarter personnel, results of a $X.XX let fourth higher net financial of or QX XXXX, of increase taxes. operating for fourth and of with discussing the XXXX. to for transfer manufacturer, year. QX in $X.X expenses a me last the R&D the along last increase minutes fourth $XX.X and the of $X to scale year. $X.X our million, spend technology due quarter about to million Zosano up $XX.X I for were stock with G&A the of expenses over million development Before up was John, fourth share, call and expenses Research reported to to compares loss compared year. associated during net share, of last year. per was million, $X.XX quarter General our contract million, quarter million our million the The associated $X.X to during million Total costs and quarter or were with due mainly and compared long-term XXXX,

compared to expense. and The million last to $X.X in our million higher compared The $XX.X of compensation R&D $XX.X and expenses expense. million up mainly expenses million loss loss $XX.X and manufacturers, contract a to per of last or due or taxes, in term had to safety we year, compensation full share, were year. stock compared personnel $XX.XX to year. XXXX with million long XXXX. per due share a is transfer associated million, mainly $X.X our to scale increase $XX.X G&A technology $X.XX personnel the study, stock were the costs For increase of is

The QX appears lease During balance million. as lease on of these component a we out tranche of of between term and equipment a a our million, downs current draw has drew down second our $X.X sheet $X.X for build-to-suit portion. the obligation broken long which

of securities quarter-over-quarter. million cash, million, cash XX, December marketable As about $XX XXXX, and we $X equivalents had of down

financing a growth number Regarding operations our to our of XXXX now through fund capital Executive turn capital our Chief remainder to including among Officer. of distribution partner that, needed with potential call the the options. Qtrypta, additional and a from a the or capital of both over With non-dilutive a Chairman obtain and and other on John? resources of combination marketing to planned cash and Walker, options equity collaboration, a will over re-evaluating the I John

John Walker

long of to six one average as XX an for year accomplishing This followed successfully requirement divisions that follow by In and FDA. with completed in long-term had with on at over in Zosano study Thank the subjects completed drug, month, dataset you, originally neurology completing announce execution month, the had final early dermal the We announcement safety an the term the agreed the million of protocol numbers completing treatment, to the ensure design of be and on order of an May, that the able subjects at on team to in XX our per average stated Last subjects of announced of XXX more that over per of pleased subjects. targeted closed six in a study. study we at that two was months we than This to required March of had XXX Greg. month. were be full per The safety enrollment those with the proud at the financing much completed we a uses we complete last months would year. entire total was least at has offering $XX in per and in new to end protocol two both October on milestones year April. completed XXX our doses

of who investigator We completed and that now fact The final full cites. have remaining many the who As have helpful we six evaluation a their year. we the of expanded have at XX been dataset in visits have XXX have over gratifying, the safety to so subjects completing the subjects completed in the be study months their be believe the that is will and able will stayed provide FDA of Qtrypta.

effects, the based and reported rate we dizziness. As applications. This related of as drowsiness, been X% reported has and side the previously, for number events investigator adverse events pharmacological approximately of X% such paraesthesia for is on percentage site have

In of XXXX. the group third capacity the a placing quarter, by to year testing of of allow by quarter announce filing technology Carolina lots Zosano in fourth able contract to their the per developed commence of agreement months material to with development required and North XX achieved their million in the registration stated with to pantheon in an manufacturing to the to site file we of signing launch. transfer up goal of of in X.X our proprietary at GMP These doses manufacturing were manufacturer with goal main scale and debility will data the us NDA, Our August. our batches three stability on keeping

continued clinical Our group exposure medical of has increase Qtrypta the affairs to community. in the

publications conferences freedom opportunity a a have well published in as recurrence the efficacy relief, to reviewed effects the the that were review nausea general onset pain treatment an rate. the had identified associated our of Qtrypta migraines. headache ability fast These Qtrypta we those key motility freedom waking year, presented a have been found with resulting in at effective past durability and were migraines, greater relief, achieving to the pain data G.I. issues indications, of morning a peer migraines, defined “difficult after with high as with as migraines” who a where to illustrate helping treatment Most and than times as the migraine from two bothersome of to of delayed recently, achieve with low due rate pain have absorption associated and severe of slow has not treat effectively most and During and effect migrant symptoms as to occurs tablet to hours of which to be from pain for oral attack. underscored their

PK studies say delivery generated the and Journal Pharmaceutical of the efficiency our I and illustrate in also of should efficacy that Science. published in We data was animal system this

the us addition to shareholders, point past of to Both In function. we and clinical, well as system development the facets a that And assuming experience out and highly strengthened joining the Controller. visible ERP during new our accomplishments manufacturing also is of with it also the to although not importantly, with Vice the implemented as come as and Christine Matthews CFO in Kitchener our accounting last finance Greg important have all role of management considerable team we with year. President year,

capabilities as Ken execution by filing the portfolio, to and three the being innovative those the needs expand And with value pivotal We have experiences new NDA and on we past their potential Elms strategic of to our the accommodate following value evolved Directors the well of and expected the to of for much members, and year of partnerships. by of non-dilutive XXXX management capture be Greathouse, direction Grais and through leveraging company. position our seek to fourth delivering governance Linda strategy expertise to adding Qtrypta creation, With a out NDA, the value our unique our to the move treatment long the acute of for term now focused Steve the for delivery to of market, their of an Board enhance our delivery those products to patients migraine. capital transition. plan quarter expanding creating a the our lifecycle to value differentiate performance as shareholders products the existing as in with our We pursue partners a the to The in of following -- intracutaneous and in needed carve further and system plan drugs milestones. for clinical is to pipeline year intend on convenience in we XXXX this welcome tasks year of for

of focus, data results positioning, sales capacity for years. Qtrypta will which we company provide and revenue the achievable distribution that writing started is new key existing to clinical the already the a of based with expect as reported the its and market agreement as based to million, to selection have the this marketing potential in achieve expectation have partner the the what submission partner, remains the the on enter we only the would to therapies the the this but sales, negotiated of for right modalities royalty, an generated and and you peak for downstream that may performance provide not and both who and greater such than company, agreement We see on XXX relative the will believe and we mechanisms future focus

by approval Of course the Drug NDA predicated is of this the Administration. and Food on our

file IND the headaches, efficacy migraine. treatment. If their preclinical the to is now in and early underserved development. Further HDX to approved, for demonstrated an study Phase Both durable portfolio, and in study commence We Qtrypta our pivotal expect the these X were are we expect five a require an plan in cluster treatment that one of in expanding headache in third to IND fast the select of quarter. onset characteristics we cluster inhibitors in our important patient efficacy group who in of

material, PK regulatory normal start study clinical trial Following the clinical for to fourth to of volunteers are file we research, a quarter. convinced hand, us in we of will data preclinical Phase the complete candidate the in Based selection in on X we and our way have significant clearance opportunity and and uniquely enable We subcutaneous intramuscular proteins, our are agents of as is that value these only and a intracutaneous of administration. as this biosimilars, an vaccines potent drive there the see monoclonal agents as to for such routes currently delivery delivered and platform intravenous position biologic by antibodies. to manufacturer

system delivery drug months build the along of half filing, the our a after drive this help manufacturing leadership of XX that owned We the to with we preclinical to a biologics. second approved programs, in partner have believe be delivery With by development NDA we and Qtrypta We agent the of intend providing end demonstrated plan in XXXX, for approval first States. a will alternative the United biologic for year. of to select on marketed intracutaneous anticipated in capability fourth

we high company team intend that execute and employees, know aim I for we XXXX, Zosano the While the these Q&A. for plans now attention and we our ability again the at ambitious demonstrated for your that partners. for build well to that our are stated last shareholders, in order year Thanks we will to open against goals and to believe envision

Operator

first [Operator Hazlett Bert question Instructions] our And from from is BTIG.

line now Your open. is

Bert Hazlett

and congratulations might to marketing Could a might potential and what consideration? might ask like? for to give an sense of potential Like you partnership the progress. of John, -- look under the optimal you forward Thank XXXX. And Qtrypta. We us if distribution the what sense agreement be look of, on range that agreements you a can about for

John Walker

Yes.

sales Qtrypta of So, fee, the would comprised costs manufacturing licensing are an indicating you upfront royalties form and the of have is be payments, as And downstream would those successful out-license in to we that area, then the agreement are clear in believe one of of be preference market. sharing a Bert milestone some I type on traditional partnership recently more aware we discussions. that clearly initiated our what

feel for is us. at partners us And take discussions and be that the marketing that reasonable a Qtrypta so submission, input allow packaging we a very timing and this partner believe as asset with in in particularly, And regard the the to a given we with time a is approach to labeling cetera in that path to is that et will very highly as this derisked point that NDA certain as of included front clear of to appropriate regulatory have potential and in such part fact filing. need aspects that in

describe along the and launch So, through a stream into generated the product able enough provide of the I that think, move I and would product. so of would be be would capital optimum lines we that to package, the from royalty that beginning

we are I partnerships to that established the and that, discussions sales said to we specialty want here with opportunity it that not strategic discussing with smaller organization to difficult that pharmaceutical any having and this had fit pharma type organizations. are groups range have of surprisingly, caution bias has predict, larger more companies marketing Now, from to

conclude in that are input such to a time hopeful we partner So, we NDA the that in able from filing. any be will to incorporate discussion

Bert Hazlett

is robust if sticking rapid of the as question And those put that you as market. you as -- program been with it's get with there look fruit two. potential be that look its with Qtrypta early an there. hanging and forecasts you. you nausea the The might that as hear a -- the intriguing efficacy is several is groups or migrainers. migraine to market, or out adopter, Qtrypta group But Thank another at at nice that you market, should it durable there early for such as for think sales be with seems those Has the the morning to peak low --

Don Kellerman

is This Don Yes. Bert. Hi, Kellerman.

sort I for patients a that non-oral those headache that are select it. in migraines difficult think specialists published -- And the of mentioned and I we those think would had to treat John a past have just difficult to treat. paper been that on obvious

response to in because gastric is those low are oral, in not treatment So who fruit really which the on important those known publish such good is I perhaps their them. paper [Indiscernible], spaces, see pretty kind due subgroups, of a the we from that's we migraines. hanging adequate And why to did patients was it getting thought to well think

that So, would I would those first are get if say, the I add, therapy. people this

John Walker

I'd a And might. bit add if to like Bert little I further just

literature migraines migraine. to it's migraines, fully presentation And reported able relief already to reference. therefore, timely to as or that motility peer have in So in to reviewed be where in due pain a in to of that oral sporadic very the provide, do somewhat either that XX% are it degree have might been that expect issues the in it's of morning the XX% excess developed difficult migraines represent of presented, these secondly, be the treat difficult to relief GI and the pain XX%

acute Vancouver, of to interested education for for back continued literature fact International in Columbia treat have strong of that difficult very British would was non-oral the conference website in And also are for treatment fact therapies made where in there pursuing a also to peer that presentation we case the for unit these medical interested to migraines. and a done in that treatments XXXX, We their on is like a there our I point migraine would the point migraines. at of Headache in research we've own in reviewed the our some population September approximately to continuing XX% parties on patient new the need

have of we of high relief, a of solely believe and triptan that pain can patients pain the market degree be position before, fast clinical data the as durability within our the basis the effect. of in we the best-in-class patient across data there that potentially Qtrypta is terms based board I've clinical generated hours of of durability that a on in So onset, dissatisfaction effect, freedom and peak said on achieve two importantly the total number as

compete the those believe available their packaging six with based the delivery zolmitriptan of of in had are approximately And related of side effectively that such our mentioned a a injectables, study milligram sumatriptan. data of on insert will our effects there versus have also that pharmacologically very that I they We paresthesia one-third injection comparison material is previously and our against because pivotal the dizziness, Qtrypta with drowsiness, in. of we efficacy as demonstrated percentage

comprises that treat migraines. over these the competitive opportunity very in I think this target position after see and going products difficult as triptan to there's XX% as best-in-class potential just indicated a market strong market against to So we a a we of

indicated, very we the and that paper component. can follow being underscored end So published so different Don tell they one clinicians and have you important as our discussions as saw a the that in of I at with up January essentially on,

Bert Hazlett

Could and makes about a scope and you build out cluster in That describe scale a little study timing Qtrypta the terms more might program like? a headache sense. you. you more the as X of look bit Thank little bit what Phase of

Greg Kitchener

So fast a There’s in fact triptan because pharmacologic XXs, to approved work terms -- been be hasn't nothing sub-Qtrypta and since the lot there good the in probably of most so yeah, been age. of a it's related question aren't would of and enough done of a really opportunity good oral, the we these profile. absorbed of products by have we we good get absorption time an been our cluster gone the have headache because to here so pharmacokinetic just think

have a pretty we some had We think appropriate for endpoints endpoints the or and good FDA had had the the dialogue -- have about about endpoints request would with what them a appropriate R&D I that be we with and study. discussion

are There trial are likely unmet a where only placebo here. again They Really to a there chronic versus versus we the -- a classic work there. evaluate because needle episodic people controlled there the are pharmacologic cluster need treatment again doses an of we so We and triptan about of is parallel unveil there's cluster. it attack the placebo. be -- two a out lower lot patients, it placebo, evaluate clinicians in to certainly and some shot felt phobia doses excited doses so sub-Qtrypta seems were both was of of in to believe two that to and important study lot seem

clinicians. with discussions having we're So

the it's really program. quarter said, to this get third a interesting think we're And As I to running. thing be up targeting and going really John

John Walker

and additional as space they're very is the Schmidt focused onset and to patients the even color where forward on and opportunity PK Director smaller excited the what think for so will it profile, Medical provide this Drug crossover the because talking that strong out a to continued as to been is very the involved it the Administration. little And as we during had of as generated investigators, the requires fast who filing also to indicated, exposure a in in about success of U.S. and population, and community, we time investigators and to they're I in by here about our of on believe in Food potential that although we estimate add effect, would it's the thought and a Don in of participate to clinical our be, durability XXX,XXX has in it's just we migraines will study year Pete fact migraine this that has plays patient or our cluster those a mentioned have us Bert, clinical NDA the under moves help period review Affairs data that bit

Bert Hazlett

Thanks. That makes sense.

the -- color in Could a Just back to me, it of so, top for top. get little one more of efforts queue. to why have anti-emetic internal you additional program in efforts the did more terms and how the risen and But on I'll bubbled additional just seems give to the internally?

John Walker

that Well, of first and dosing is the molecule a system current compatible use so we foremost, and requirements are Qtrypta. delivery that with small has with type on, it our very that

work doesn't development the the it was of filters of that or on require applicator programs. one any patch follow terms early our at looking additional So, in and on

the in are In most addition overall a delivered a hospital inhibitors with by where way potent that reasonable still that, of to setting, X-HTX $X market, the of portion IV. billion it's

vomiting, an believe type be that offer clinically we offer. effective market move and uniquely positioned these as that in, we able in which perennial we very be the based outpatient based inhibitors nausea and to system induced so, as on the for delivery into well of unique example, chemo, those alternative will to take more hospital to And delivery setting, are the that system

the market good available be a anti-emetic and in if will, market. see you for perhaps we opportunity with there a sized the effective into lasting, opportunity longer more that So, playing to

Bert Hazlett

Congratulations look forward there. again. progress We'll once Thanks. to

John Walker

Bert. you, Thank

Operator

your [Operator participation instructions] Thank and today's gentlemen, program. you you. for concludes conference. thank the Ladies in This

disconnect. now You may

Zosano Pharma (ZSANQ) 14 Mar 192018 Q4 Earnings call transcript