PTN - Earnings call transcript Q3 2018 | Palatin Technologies, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the Palatin Technologies Third Quarter Fiscal Year 2018 Results Conference Call.

As a reminder, this conference is being recorded.

Before we begin our remarks, I would like to remind you that the statements made by Palatin that are not historical facts may be forward-looking statements. These statements are based on assumptions that may or may not prove to be accurate and actual results could differ materially from those anticipated due to a variety of risks and uncertainties discussed in the company's most recent filings with the Securities and Exchange Commission. Please consider such risks and uncertainties carefully in evaluating these forward-looking statements and Palatin's prospects.

introduce your to Dr. for like I'd you host to today, Now Spana, Officer Executive and Palatin Carl Chief of President Technologies. Please go ahead, sir.

Carl Spana

and morning, will Year Chief and On am is Steve Thank Third Financial with me and Officer Good and Palatin's provide call the Palatin; call, operating to today's you. today the Palatin President Quarter updates. of Fiscal Officer. Carl Executive XXXX Chief Dr. I Wills, financial Operating on Call. we Spana, CEO welcome Technologies' Vice President,

Now, I'm the turn call over the financial to provide going to Steve, updates. who'll Steve?

Steve Wills

morning, Thank Hypoactive North you, and notify Carl, Starting is Sexual NDA XXXX, HSDD. FDA Desire to NDA bremelanotide, which American for Drug third bremelanotide, a and that XXXX, in to recent the respect good will this quarter review. us XX, March ended June Disorder submitted operational our submission of significant the licensee is AMAG with New accepted Pharmaceuticals and In for FDA Application, everyone. March under anticipate female the and for include: highlights financial we exclusive with that development

have to licensed in Korea. Pharma China and We Kwangdong South in Fosun region Pharmaceuticals the bremelanotide

clearance data positive discussions development the May and and for inflammation in of at inflammatory XXXX X bowel licensing In in under are Conference. an the potential health XXXX, we Colitis we human oral XXXX, other With TIDES application first data at presented clinical multiple of melanocortin PL-XXXX in XXXX Meeting respect disease. FDA territories IND we for studies. the XXXX. dosing calendar Ulcerative addition, In in the formulation April subject for on we in Melanocortin resolution other agonist presented anticipate and programs Symposia receptor and partners In pre-clinical pre-clinical Keystone bremelanotide additional of February initiated on for half closing with collaborations second to PL-XXXX received our diseases,

in fiscal for for diluted year net compared reported $X.XX XXXX share recognized $X.X of our between in and the March AMAG. or and our XXXX, three third offset ended was million pursuant in net loss the to mainly quarter is difference XXXX decrease March loss to operating million decrease results financial XXXX. same revenue and financial XXXX that the XX, The expenses quarter, $X.X $X.X share a of with ended during Palatin period, the results due basic diluted financial approximately of period months a by million of per agreement basic the the million or into Going total regarding of to $X.X a XX, results, license XXXX for $X.XX

the recognized compared quarter revenue March $X comparable to XX, in quarter licensing the in revenue; ended Regarding XXXX. $XX.X million contract XXXX, for million for we

agreement recognized revenue AMAG. of periods, the our to both XXX% license For with related was

as our attributable professional expenses; were total XXXX of FDA. and towards connection with to decrease in filing closed expenses secondarily $X.X operating Regarding was expenses to for agreement development rendered our The primarily XXXX February of operating operating the services of which quarter compared decrease with we with NDA for the the million AMAG stage expenses million bremelanotide the in XXXX. to license XX, ended period same in the March in the advanced $XX.X

the XXXX. related interest our XX, of XXXX million million other expense the for for quarter other $X.X March ended Total compared Regarding other expense income of for both expense was $X.X expense; ended debt. primarily income to total venture to and net periods XX, quarter net income consist March

year support an in $XX,XXX XX, and the Korea be ending will with Regarding as Kwangdong, the China XXXX. Republic tax accordance respectively was in income to bremelanotide requirement expenses; of and tax fiscal with pursuant recorded agreements [ph] our and and and June Fosun withheld license expense $XXX,XXX during

equivalents deferred revenue current March to June as revenue at liabilities Regarding million, of cash cash million XX, accounts XXXX. million XXXX. of to as Palatin's XXXX of and were million of Current cash net March million XXXX cash December net $XX.X XXXX June cash compared approximately $XX cash $XX.X XX, receivable equivalents and $XX.X and cash, working and were position as million $XX.X of of of of XX, XX, and $XX.X capital; equivalents $X.X deferred XX, compared of million at

with XXXX of shares As common sufficient to program liabilities pursuant fund no quarter. time-to-time our have any under an has may will offers this $X.X as suspend which under solicitation current into XX, we agreement. to obligation that of $XX.X shares resources its stock We any LLC Palatin In million. Genuity at to agreement April commonly existing ATM approximately Palatin June operations December believe deferred of of be current the approximately XX, and market were referred an revenue entered time equity net at from sell this XXXX, Carl? Canaccord million, sell capital XXXX, least to agreement, distribution through and prices. planned may

Carl Spana

our completed review for hour lead American the auto-injector, in Sexual second bremelanotide's which Disorder. March end is The Steve. to patient subcutaneous first product in class a clinical one of XXXX. calendar FDA drug application I product. single-use the sexual operational Working partner as bremelanotide submitted fiscal We the AMAG we update bremelanotide, with agonist for XXXX. licensing North melanocortin by clinical of complete accept is to Desire formatted Phase X our anticipate will quarter trials only the the simple to start for FDA year full is drug before with AMAG a Bremelanotide third the XXXX Thank on-demand which quarter prior a NDA self-administered you, approximately for new Hypoactive bremelanotide, that activity. the our will Pharmaceuticals,

are drug Pharmaceuticals we to working with Korean bremelanotide America, regulatory bremelanotide to Chinese anticipate AMAG with goes in if Outside working licensee our those of approval Fosun and our Kwangdong development currently FDA towards the and support advance we in new are all XXXX. South territories well, licensee filings. We bremelanotide application North of march Pharma

for with additional we As territories mentioned, have anticipate bremelanotide Steve year other and partners calendar licensing also ongoing closing in potential XXXX. collaborations multiple discussions

on drug for we autoimmune fibrotic to Melanocortin Palatin's other our program efforts, and on focused naturally our development peptide inflammatory targeting and Program are diseases. Moving cardiovascular primarily diseases

calendar by in We including PL-XXXX, regulation is have arthritis. uveitis new and rheumatoid our families dry selected developed controls Ulcerative the for disregulation inhibition application eye, with of B a and Anti-Kappa development pro-inflammatory clinical Phase bowel down [ph] immune X Colitis receptor cytokines. melanocortin of highly candidate X agonist diseases of and receptor system specific lead disease, and in Activity broad autoimmune melanocortin of inflammatory inflammatory or also disease is demonstrated development. autoimmune trial in is PL-XXXX formulation Phase clinical PL-XXXX a of The inflammatory, X has to X in study both the to in XXXX and of models. the second expected reversal XXXX quarter half X animal start of completed of third the study is Phase targeted oral in be of of the PL-XXXX XXXX. formulation

for end including drug this IND treating a of X ocular PL-XXXX, year X calendar inflammation Our is as eye an filing the dual with as later completing activities and calendar receptor development disease candidate early with agonist. melanocortin dry preclinical anticipate PL-XXXX under XXXX. enabling We

our fibrotic is hormone candidate scheduled XA has multiple peptide peptide with fibrosis. studies for a failure heart is conjunction Phase growth IND-enabling tetrapeptide has peptide therapy in fibrotic centers the and naturally naturally is peptide diseases. partly area C preclinical May PL-XXXX, Phase on start and processing use the deficiencies. naturally peptide with system cardiovascular the a and trial both cardiac synthetic developed major to XXXX. developed completed X cardiovascular PL-XXXX This A diseases suitable agonist drug PL-XXXX in preserved application or peptide in receptor to Palatin other receptors, replacement that of reduced evaluation Our for ejection programs of research a studies. focus including of patients in for and fraction agonist Palatin also naturally reduction in has with potential and including is

We to biology chemistry. leveraging by our also in portfolio been expertise have melanocortin working expand in our product

adult a the objective developed and with and are conducting selecting to chronic preclinical activities including both populations pediatric of of orphan rare potential designations. for compounds We diseases genetic an qualify with in treatment

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may treatments X receptor chronic that developing to also mediated the for pathway. rare melanocortin are inflammatory disease We be

program find www.palatin.com. website can additional on on our You information our

our not As concept very X about I treatments resources of to lead developing impact to could trials excited only provides through multiple programs in the bremelanotide provided developed success our we the the The but of the pipeline with the programs. partnerships future am has new the significantly commercial company, realizing have bremelanotide, our resources in of value patients. to by value think had from of and the that unlock us now potential lives clinical Phase we

and March the potential Pharmaceuticals We'll have support with we track are we to following for on XXXX. bremelanotide year, the the Over working in approval diligently next NDA be AMAG objectives. bremelanotide

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that to preserved complete peptide Our the or with following the heart trial is PL-XXXX fraction. naturally system ejection has program objective; distract in failures

initiate for following of for Ulcerative our for the multiple formulation; the ascending as treatment and to peptide incomplete dose require clinical treatment activities completion ascending study, of a an PL-XXXX, Phase studies. objectives: X eye Our studies single to in programs initiation to begin disease a Colitis, system melanocortin human dose the for are dry and oral of preclinical first PL-XXXX

for activities treatments Palatin and objectives treatment chronic results in of building advance Management value targets remain and shareholders. studies to the analysis on of select preclinical employees our objective based from into assessment our rare potential our for of development and focused IND-enabling on our Our work. achieving compounds genetic and is for will diseases and

you to information on I on participating our like call for said reminder, the www.palatin.com. would and thank a all website, now open of questions. as As I before, we find our will call you can to more

Operator

Pantginis Thank first H.C. with you. Instructions] take We'll our question Wainwright. Joe from [Operator

Joseph Pantginis

questions guys. bremelanotide. so morning, of Hey, on should or Good couple A I the quick say. afternoon, good

potential Thanks. questions the do for ADCOM? you're what the what First, timing you the specifically, looking that more an panel? is from are expect But lead

Carl Spana

an of in more be year; done. we could November-December anticipate year. get it would ADCOM, And probably would timeframe, like we latter think guess, calendar this Timing when so to that's the would I of it FDA part be the the towards

an will going we questions an with drug feedback when would we always direct think desire. how to and any I we opinion Joe, that the think forward. saying yet, that information of as our have filing around used, how associated don't intimate The impacts we ask, distress be get what is bremelanotide but we desire both will would some letter we expect receive Although questions, that is

those were think questions. the I

will real any major typical, be I issues of obviously think part safety product be will should there officer there sure will they think coming safety that's concern questions the labeling, out appropriately? safety pretty I'm how program. panel there's the don't any I meeting. at but clinical around be labeled the I I press a panel on have as there of the that don't think

for very held in bremelanotide particularly and I is a that new meeting typical molecular is. think entity, with it's panel as first class

I roughly FDA that's focus. So think where the will

see. will We

Joseph Pantginis

advise at And to pivotal looking you're looking EMA assuming. EU for the I'm then program, regard obviously Europe, with to obtain

So anticipate the protocol do program? in to what if X any Phase changes U.S. you compared the

Carl Spana

the way Obviously, for feedback using Europe group bremelanotide we appropriate review would most same process that and in in waiting from CHMP be we are the be most separated, and we so and we and study both between will the are feel pre-menopausal feedback studied in pre the in approaching that desire to separate likely of is the way have or as them they U.S. then trial the indications. know one endpoints. prior distress probably populations -- continue We in co-primary as post-menopausal post-menopausal and single to require that from

form that can U.S. data really For the possible. want and U.S. that we support of wants the filing in that in us make make the so to therefore us, sure the did we to we sure will use one trial as we closely the

Operator

our from on, John take Newman Moving we'll Canaccord. next from question

John Newman

panel. FDA upcoming question My the is regarding

you could the to disorder attention actually to in continuing wondering clinical Just the panel draw terms of think be that if well as profile. beneficial as this highlighting

to seem media I think of drawbacks. your a in some attention last the that drug the was lot potential -- the that approved to despite of get

about in to how you that the Just think regard. panel curious as

Carl Spana

panels has to of as they're to open period and also can Just part required speak people and have a ADCOM, as that point comment be by submit they the of it pre-scheduled can a written to in to request an as well. comments law, included and if fact; submissions be submit

open that I the able When an a to topic. will front to of on expect that be in a say commissioners expect the likely that you supportive like There session coming public of in out. comment I certainly and that there most its to Of right panel riding the we sure be around as of in lot FDA. had will comment we Congress, to period, I to this to they can So and they by be do that people the the we was and panel coverage opinion by of the Obviously think public what will relations with the for period, ADCOM do will fair senior division have period. is amount making this in in based certainly general product public important have would just experts put product. or nature. have publicity well to AMAG meeting panel public what members comment the possible to a a to they've meeting work participating of have extent influence

But be will our with that as on lead at point, that in the bremelanotide we make and there gets people I attributes supporting at really working the very robust a are public that working across. sure the diligently AMAG more well-run will really very it we they're discussion them. the I messages and So a expect Palatin do know your to session. working be direct very and know on that team we in of robust I meeting highlights AMAG panel have to and is said,

John Newman

that? might And start question after product. plans to you have assuming the and do to drug point conduct for to an do appropriate one Obviously, AMAG FDA conjunction have the DTC wait approval decision, aspect so, approved, with it the additional commercial thinking at the of marketing we but on think is about what if you be in

Carl Spana

for can I think would a for up to have already I It's begin think Absolutely. has website as product disease be where that direct-to-consumer at to a well. the in jump Certainly, Then AMAG websites. important awareness. at We advertising Steve would point success. expect some can it we're AMAG product. there

as I think that's very critical well.

think mechanisms we're probably at job very online. They're being with comfortable of approaches. forth available but obviously, do label FDA with that very a very all they've that, that that. When practitioners good and so a discussion patients products media will that through those be I reach I you radio, prints, on of done that direct-to-consumable good you the good that, so and AMAG start using sorts job to with markets can types really So and can't the building have the other comment so your depending other on on

Steve Wills

these in education really be We're to already their to call as about very from them. or stating timing. collaboration. discussing the the of mentioned standpoint supporting an add FYI prepare we Carl and things of and It's for so specific Frankly, their process. that's in there review other with comfortable thinking they're types Carl for and more Steve, are it now in regard. awareness comfortable are synergistic the John, about now franchises, they're very a am they're We're we're support conference and again, that They're not advancing. from going that role as than much a more from FDA-NDA ADCOM where that I for the with taking we prepare complete both we're albeit as the to AMAG, in certain pricing extremely place the discussions This markets, is in significant more product female role all it's healthcare them. the that things

Operator

it like closing additional to speakers turn any today's this conclude time or our Q&A that over to for remarks. session. I At back would will

Carl Spana

you thank about is for the to and working We conference forward at like exciting company. of participating we Technology's I'd XXXX next Palatin quarter Well, in future everyone hard It's updating make quarter excited to Everybody here look continue company. the third progress. time as call. we're year an the the fiscal to

So and day. great a you for participating thank have

Operator

today's this conference. thank will for At time, participation. that your conclude you do We

You may now disconnect.

Palatin (PTN) 15 May 182018 Q3 Earnings call transcript