PTN - Earnings call transcript Q3 2019 | Palatin Technologies, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the Palatin Technologies Third Fiscal Quarter 2019 Operating 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 may 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

morning, year am today is over Thank third Technologies. and Palatin’s to With and turn Good and Wills, the the Palatin to you. call call, we today’s on Palatin Executive Officer. President quarter of fiscal Carl Operating On XXXX Dr. I to Steve me financial call. Spana, CEO provide President, welcome Vice who’ll going provide Steve, Chief operating financial updates. Chief the I’m Financial call Officer and updates. will Steve? Technologies

Steve Wills

Carl. Good you, Thank everyone. morning,

development with Vyleesi of to exclusive Pharmaceuticals. study Regarding been study HSDD. daily dosing and operational which for and has sexual Palatin’s desire for to has And XXXX, been premenopausal name Vyleesi, Data March North is volunteers respect short-term quarter XX, our financial the by America, FDA FDA. AMAG highlights, Palatin under that for requested licensee female disorder ended assessing use hypoactive or frequent with from trade is bremelanotide the completed submitted

inflammatory On respect collaboration of for and autoimmune regions for the in the Palatin front, diseases. study PL-XXXX positive an America, outside bowel North territories other programs, to With ulcerative topline partners our licensed announced of anti-inflammatory South clinical certain we with discussions Korea. Vyleesi China business colitis of oral advancing development potential is and and results

fourth million the XXXX. proof-of-concept AMAG. respect approved from ulcerative calendar X of of PDUFA portion future fourth clinical to these is patients systemic FDA are XXXX And with and of the calendar is in in of We milestones, also. commence formulation colitis to With Carl XXXX. commence XX, PL-XXXX in of during a proof-of-concept Phase study X to X receive Palatin on the study is studies quarter will advancing formulation commence activities to if presentation. to uveitis June his is quarter with year anticipated a Phase $XX due date clinical colitis clinical expand oral milestone Phase in the PL-XXXX ulcerative patients anticipated non-infectious uveitis. proof-of-concept non-infectious in year the program

XX, recognition three the of net a for $X.X and million per quarter net million period period $X.XX results reported the due March same during compared ended per ended license diluted financial AMAG. basic mainly diluted share difference March in between the loss our share financial XXXX March was XX, the to results of $X.X for the XXXX, XXXX. to in or Palatin and basic million Regarding of loss quarter to months the $X agreement ended in with or XXXX zero and pursuant XXXX, The for XXXX and license revenue XX, contract

three ended Regarding revenue, there in recorded were the XX, March no XXXX. months revenues

For the was three license of XX, our months $X March agreement recognized revenue related AMAG. ended XXXX, with million the to

expenses operating the clinical Regarding the the XXXX. in compared operating quarter the and in XXXX, in million for Vyleesi ended for million, ancillary XX, FDA NDA of trial expenses Phase March with were file $X.X completion the to quarter XXXX. reflects The the total to of program studies March X comparable expenses, necessary operating $X.X decrease

least debt $X.X June related million and XXXX, $XX.X to fund that debt XX, will our XX, liabilities capital which that at from sufficient paid working compared XXXX, at position Regarding debt XXXX, is decreased quarter be March $XX its were and existing the By June at million million XXXX to cash Current of were $X.X June million resources XX, XX, of XX, capital, at to venture XXXX. million, March XXXX. XXXX. our liabilities calendar through at $X.X XXXX. cash cash at believe equivalents Palatin’s Palatin off. second $XX.X Carl? at million at compared million July March be to of will XX, We planned $X.X operations all

Carl Spana

clinical complete is is sexual Vyleesi is melanocortin X drug patient to disorder. first which hour class trials Thank Vyleesi, autoinjector agonist, you, a simple Steve. operational activity. on-demand with start I’ll by approximately the update Phase hypoactive desire only in our to product. the for sexual single-use lead successfully one clinical the a prior Vyleesi self-administered

We which labeling our XXXX. FDA partner FDA in June March use NDA PDUFA a and the regulatory we advance are Outside those June accepted the with in North daily in the of We report the Pharmaceuticals, Pharmaceuticals with was the to Kwangdong and drug Vyleesi with our date the review AMAG XXXX to American to Chinese we is working North territories of FDA. application, development provided new study requested XX, June Vyleesi decision for been by working Vyleesi and new partner for The FDA in review XXXX, the data Vyleesi with we in XX-hour study XXXX. data that towards the pressure AMAG discussions the South review have haven’t and could the AMAG The final filings. submitted support assessing been FDA submitted America, for our ambulatory term FDA the by licensee Vyleesi. Vyleesi application Pharma short of clinical the believe completion has to In November The all XX and completed. study NDA are partner requested with currently information requested for date. additional Korean our drug licensee, PDUFA Fosun blood in

is Medicines application. the use Union that only on Program, Development study indicating of Products advice Union Vyleesi Medicinal European licensing X a the single Phase in needed the Agency European addition, In for the European human support a Committee provided has to for

natriuretic receptor genetic Palatin’s Now and melanocortin diseases therapeutic moving inflammatory interest, on of development to auto forms areas programs. Palatin’s has and melanocortin and agonist program peptide obesity. two drug immune of rare

in of with in broad agonist eye, autoimmune uveitis including treatment dry melanocortin highly and other diseases, selective disease, receptor inflammatory applications bowel inflammatory We new potentially the developed retinal diseases. have of variety families of a

formulation and clinical noted. a will diseases. of broad X In from Phase healthy applicability and to oral Phase lead systemic potential the bowel deliver administered and PL-XXXX dosing development a disease. X well indicates an as is receptor for the that first dose XXXX, of this PL-XXXX believe detectable to a treatment a The subcutaneously we of end exposure. study pharmacokinetic In one the inflammatory volunteers potential have PL-XXXX, as colon agonist. completed highly oral no completed concerns formulation safety autoimmune melanocortin without PL-XXXX of tolerated that single multiple data were the Our inflammatory study was candidate ascending treatment can at PL-XXXX study and selective potent for quarter We XXXX,

for that affect the with autoimmune system two PL-XXXX are We year. eye currently the studies targeted clinical this and later diseases gastrointestinal enrollment to developing start

preparing a in colitis study of proof targeted to ulcerative XXXX. conduct fourth patients, is X the We to principle Phase start in of are which quarter

also our diseases a activity In for retinal replaces potentially for addition, study, targeted in conduct principle better melanocortin ocular which our and preparing are of and non-infectious PL-XXXX also this fourth patients, X of diseases. substantially proof agonists excellent we PL-XXXX inflammation. dry term patent eye to PL-XXXX demonstrated has year. animal is efficacy. providing longer uveitis models Phase of quarter in to PL-XXXX compound of start autoimmune

eye clinical to of as in are eye in XXXX. developed PL-XXXX We potential and a for drop half eye treatment formulation studies an the dry of start have first calendar dry anticipated

diseases. believe in with our treatment by Regarding to PL-XXXX potential that is with cardiovascular patients conjunction and the of agonist C start Heart dual a half cardiac fibrotic American candidates, PL-XXXX, use We PL-XXXX in PL-XXXX potential for in for treatment a X evaluation failure peptide major with And trial A natural Association as in diseases; lead first centers fraction. sponsored including heart and development scheduled the a at for fibrosis. as is XXXX. preserved ejection has a preclinical Phase receptor of naturally reduction research fibrotic

and to looking the FDA NDA pipeline. on our We’re product the advancing forward Vyleesi decision

for now advance clinical with needs. multiple into high positioned medical We variety to of are diseases unmet compounds studies a

initial multiple inflammatory begin uveitis studies oral study sponsored of American second early in Association colitis to the patients. diseases in clinical dry initiate into will ulcerative And preparing including of enrollment PL-XXXX, X in half We formulation for advancing Heart Phase for are our PL-XXXX we is XXXX. ocular eye, studies

believe We We have have pipeline that fibrotic long-term a potential growth very clinical product exciting of that candidate in diseases. we PIPELINE-XXXX and value. possible for to positioned treatment drive shareholder a is

I’m on can our find going to website At You programs you. questions. call open point, Thank this and for stop the information additional www.palatin.com. our on

Operator

Our from Thank will question you, Canaccord. sir. first with John Newman Instructions] [Operator come

John Newman

has like Hey guys, the study of for completed. It question. the been seems the FDA requested thanks

you think shape this comment agency in could Just has any the you’re requested additional or to as there. wondering whether data you good point Thanks. if at

Carl Spana

this agency. that point, information the the there At no we’re for Thanks Sure. additional are question, from working John. off requests

everything that think we’ve as we’ve they we stated, And we moved and discussion. in we’re So labeling on them given need. that

less XX we’re date. So than from the days now PDUFA

So we’re say. very to what the FDA hear has excited to

John Newman

are that in we more the how not additional Does work term the something that of license? should something time. for on terms And partnerships great. United be bit great, or new event take currently territories States that of going Okay, probably would you more of that’s think a in that outside be Vyleesi, about a thinking

Steve Wills

Steve. it’s John, Hey

date. But going multiple advancing you’re you’ve in time before – get we’ve we’re now with been, a been where parties. We’re going. is to discussions to for because to right few happen PDUFA Nothing acclimated socializing FDA people it takes the quarters, where now

we that that the have then the the calendar to territories multiple territories, the the little these Coke I’m try end expect phones as expect the we going before these go and The licenses. right hope date meetings dog as aggressive and get – XXXX. the We’ll but position, is where a in will get to of rest PDUFA have we hot traditional executed soon finalize with and So we of and this non-licensed what hits, get back and approval. on world

expect approval, we’re And we will prior to, believe you And not talking knocking that good advance the we on increase. door. once, activity some can to talking that as will – but anticipate that the post that discussions so we’re people can have interest. We approval, only the much that there’s people the you of the to frankly

John Newman

Okay, great. Thank you.

Operator

you. Thank

Pantginis with Our next question from comes Wainwright. H.C. Joe

Joe Pantginis

question. for taking Hey thanks the guys,

don’t You ambulatory does the follow-up data any the submitted, was requested actual regard you so said that like little any they info pressure that if generated from thanks regarding were to any you FDA a Can it Just blood was appear mind. additional study that. info, do study? that hasn’t for With provide hitches?

Carl Spana

label, help question. not disclosed has as know What someone’s is in study AMAG for labeling product leave to labeled can you I the Joe, AMAG And at case study daily doses to that took the the that. The We’ll we’re since patients really the discussions. how is say would the or inform that on multiple think Hey be knew study of now ask was data. designed going in drug. patient in to I I moving

label comfortable to of use. for First I’ve allow will all, the data agency pretty product at appropriately been the the safe

Joe Pantginis

Understood, with the $XX bit could potential financial understood. obviously And I the to nice switch for a million a have milestone. of little infusion just you real if standpoint, cash

milestones curious remind was potential recognize considering and Can are and is from you payments milestone – Kwangdong. to future are the standpoint what I us Fosun revenue you as or a as deferred this So this revenue, from going P&L then well.

Steve Wills

would cash the some date will this There’s it If planned, million, in stage. quarter, The PDUFA Thanks, time of recognize deferred is XX. – payment this the for type $XX at be no XXX% The July. June Sure. Joe. in that goes receive recognition actual actually revenue. everything recognition second of as say the

just to quarter if planned, But go XXXX. in the could is of Regarding over on milestone is next come the $X for in other, the is license Fosun that focus two $X.X which milestone we regulatory and It’s that Korea, have same of approval. China end rather. the regulatory the type – – less, China. the as as deals a internal quarter for things next of little are estimates we’re first China, for with there XXXX bit aggressive, Kwangdong the our regulatory that approval Switching like XXXX. timing event, is And a is the is next of the million. And or the of actually million. as but South XXXX. Fosun A first the But the is milestone the the internally same little and early it that’s XXXX. with X, end calendar the expectation trigger as the chance our

Joe Pantginis

a Thanks lot guys. Great.

Operator

you. Thank

with Higgins Michael Thalmann. question next Our from Ladenburg comes

Michael Higgins

Thank any you, AMAG’s blood We operator. given results? FDA the has earlier from this follow-up monitoring we with blood were in you the or on and Good label, whatsoever that pressure morning, comment feedback guys. on the discussions week. ambulatory a agency study understand It’s them pressure the the monitoring

Carl Spana

not No, that have any I been, they – has for but would given some that it. would expect they –most I feedback they expect I expected occurred. wouldn’t additional request have would analyses, when not on haven’t information would. have

Michael Higgins

to earlier Europe, about had hear. looking to comments And then great Okay, that. you some

Should Just entire looking you take PDUFA. across by front for would some we summer of region? the clarity Europe, or more more likely structure for partner deals ours following the with then such look loaded would anything the you as fall? the assume the June country got in so in partnerships are it in of and for some look partner that these, the that And that end deals. country XX more backend time don’t have And versus you’ve structure to a be European talking I

Steve Wills

Michael, and our We don’t could We be strategy, Europe of – believe of parties some Hey, – to we European territories. frankly, anticipate this the and discussions a decentralized we’re is talking it’ll based very partnership. anticipate on Steve. the all multiple take can don’t

discussions country as of Asia of a separate lot being in a could The based appears be and a initial we not Europe be but Pacific, our Zealand Australia, America India So one New on some that Latin by definitely licensing separate would territories of territory. some these territory. have country times, territory, they a companies presence for Europe. look as

to when it’s summer timing, definitely is the the going Regarding be, mean, I date. starts PDUFA

aggressive. So that would ambitious and be real

targeting the quarter. we’re So really fourth

into going the we fall by the end but believe calendar winter, we XXXX. of regions So the will license multiple do have

Michael Higgins

the your did time in you of start, helpful. a then pivotal lead you you start before pivotal That’s the end may, Europe? Also before Thanks. for if Okay. start look year can

Carl Spana

a work doing now. actually We’re lot of the

now took we we’ve sites. got we’ve making a which potential together the feedback, that the together, identifying lead protocol putting So we’re correct and sure and regulatory find the you’ll protocol have,

as a be and that be have turnkey we preference coming up to that will we they make run. to that Europe the starts. to just that a obviously, the not be licensee can It would the as for easy in in that. we do lead they maximize our partner start downtime that So at running this operation respond on would trial and But essentially would possible before make pick sure

lot a getting work the We’re doing of it ready.

Steve Wills

in didn’t Carl let your Michael, jump part I that Carl. for one Hey just Thanks pointed out answer me of that question.

on it’s really approval. royalties depends and which be approval. a be And something sales South up specific to deals, versus going as the and say to the milestones forward, front go on, overly some then Fosun similar a can’t on It going is structure region. Korea structure, Regarding you the there. go it larger the I is upfront, something to

want the Our program, I the regions. whether or main other advance thrust to mean is Europe we

flexibility look variable when good for more and We relationships some variable good there. and us, for for have we them happened. milestones partnerships So

types I sharing feel think the parties with of proceeds. better both those

So hopefully was that helpful.

Michael Higgins

I Yes, Appreciate definitely. our specifically your in that. Thanks. PL-XXXX. to turn can attention pipeline, If

any trial You end. going like would on design size of on Thanks. can them the before and those getting be the But help give us looks helpful. you’re timing subcu year the studies health some

Carl Spana

a oral will controlled this formulation concept study, be study, about eight proof with to a treatment Since doses two there’ll duration Sure. controlled the Ulcerative here PL-XXXX. colitis these be weeks. is an of of trial, a traditional trial pretty be randomized is

outcomes, But be are additional would ulcerative an outcomes a so this colitis since at pain principle mechanism stools, and of looking of for which will look a as proof so and bloody colonoscopy also clinical a that and is extensive examination trial, on we be really will forth. reduction study. you We well, lot doing

And then are three the Size inflammation and as the the intimate be our a And colitis maintenance improvement a of study. these, be as terms, in looking systemic over colonoscopy study, well to the size. drug again, administered they’re and not biomarkers in vision types outcome there’ll in the eye. ulcerative around at improvement And ocular is doing huge biopsy colitis outcomes, of arms for those at around shorter well. be subcutaneous the of retina, So – a But looking be will really to ulcerative overall studies. uveitis, lot a then the that’s you’ll going patients as the dosing. on study same be will studies, will XXX of there of clinical be and both no through the so the combination probably

are studies performing. So what would at types of show to these going get are dose mechanism efficacy very how efficacy, housing classical first again, patients to to sense look of a take

Michael Higgins

time big four. Any at is comments the And year hear then is the of to backhand of it to Okay. for start the you’re one has nine, some think XXXX, there that still drivers want timing for looking I it. a that? on been I for three,

Carl Spana

we’ve forth. two drug we’re optimistic the not now. it’s American regulatory and the – Heart are institutions which study. But we’re by on have leads – the the academic is We’ve that supply, we it’s It’s running support, really Association it. so provided had running IRB are do funded Well, the – so approvals and and

June. We delivering will drug be late in

they’ll we start. optimistic as that to we’re as soon delivered drugs So that, the site

review it but drug, it’ll first be institutional half, half will get their are if in It’s study now your And second really good appropriate have ready all taken year. this early I slides said the with late appear it of second as board. does a to going, think early that approvals hands, from should and as go we these a half. while start the I to So in study

So it in the should start summertime.

Michael Higgins

the Appreciate feedback. Thanks, Okay. back jump I’ll queue. the in guys.

Operator

the time, it this like now closing remarks. to showing back turn At you. I’m over I Thank further questions in would management for no queue. to

Carl Spana

Thank for this end the to Obviously, us. to is on call the you very had. of questions all a participating we this is good going the exciting be – for that and time going be quarter

are we outcome we you. the a lot Next will a after and discuss with to be optimistic we date. PDUFA time positive have And will speak that

to being the a So we’ll speak with for next you on call day. have said, Thanks quarter. and that great participating

Operator

and Ladies Thank teleconference. you. gentlemen, concludes this today’s

You may now disconnect.

Palatin (PTN) 9 May 192019 Q3 Earnings call transcript