PTN - Earnings call transcript Q2 2019 | Palatin Technologies, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning, ladies and gentlemen, and welcome to the Palatin Technologies Second 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 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 second 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 financial updates. to provide going to Steve, Steve? who'll

Steve Wills

Thank you, Carl. And good morning, everyone.

is ended million XXXX, desire XX, with sexual North under milestone if note, Regarding $XX December Palatin's is XXXX. financial which American our for licensee. and development recent disorder highlights, or quarter to Of to is June Vyleesi, receive Palatin XX, a date approved from and HSDD, hypoactive operational due Pharmaceuticals, the female AMAG respect PDUFA FDA

certain collaboration Vyleesi and as development. the Carl our business his America, as in China expand for South is Vyleesi development the of portion under territories during North other well licensed the on partners Palatin the will On programs front, of with regions program Korea. discussions presentation potential outside

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

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

AMAG. was agreement to the December the our revenue three recognized of with XX, ended XXX% Palatin related For months license XXXX,

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

also million Palatin's cash December position at equivalents to XXXX and and cash Current our XX, Regarding liabilities million million $X.X capital existing working XXXX. at XXXX at through December related $X.X its has XX, capital, XXXX. million XX, to and at XXXX XX, from XX.X million resources at sufficient cash XXXX September operations $X.X fund be XXXX December September will XX, million and $XX were our Palatin are million debt September of liabilities XXXX, $XX.X XX, planned compared June at to to $X.X We March XXXX. believe to XX, fiscal decreased natural million XX, Carl? were at least $X.X year. XX, June at compared that

Carl Spana

Pharmaceuticals, AMAG assessing Vyleesi, submitted as accepted was XX, and of to June for blood Vyleesi patient disorder. Vyleesi. self-administered sexual regarding complete additional in the Vyleesi new discussions our the new one application pressure to for the are clinical North three will advance I'll American start of its application, XXXX. for with is support Vyleesi a daily of XXXX. to agonist Vyleesi which FDA drug the the studies for the NDA We've The short use part subject Phase data have Palatin prior for working In only licensee the review or our class Vyleesi XXXX X XXXX, in drug by per term a date conducting AMAG the June or subcutaneous in large March to approximately by Vyleesi activity. with XXXX in review single-use to FDA In operational Product's submitted the hour submitted with the data been PDUFA four ambulatory the partner our is the melanocortin per to FDA sexual you, AMAG American Phase November is of product. hypoactive and Steve. clinical approximately and Vyleesi month two lead week. with XX-hour FDA PDUFA drug about date. Thank study autoinjector format times the first simple desire is currently once requested NDA on-demand June the XX, Vyleesi, update X FDA North trial which

Outside a towards regulatory requested subjects was informed that the frequently. filings. there purposes. or dosing short Vyleesi Kwangdong working labeling of more licensee to Vyleesi designed use Fosun to of daily our provide data are our on Pharma Korean small However, The licensee, subset is we study territories development with Chinese South Pharmaceuticals Vyleesi North of and America, in advance partner those term

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

to Now melanocortin drug development development earlier which programs, four include receptor agonist. from Palatin's moving on

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

treatment pharmacokinetic PL will a autoimmune their noted. and healthy announced receptor candidate tolerated an completed were oral single PL-XXXX dose study of one administered and a concerns We potential X subcutaneously bowel and diseases. study, selective study applications inflammatory ascending multiple Phase formulation no data expected quarter XXXX study, ascending dosing of as treating highly for broad melanocortin PL-XXXX development PL-XXXX have this lead inflammatory The first a Phase results in potent in also in we recently of Our We've volunteers. potential X safety XXXX. the which in and agonist, well is of disease. was In is believe

half studies PL-XXXX of autoimmune is X conduct PL-XXXX support study study and the and This to with efficacy is in step activity evaluate variety a will designed data to that Our to needed a clinical larger diseases. provide start the of is next of Phase Melanocortin to ocular safety as XXXX. X preclinical to agonist uveitis such variety first and that in is our autoimmune treat in potential diseases the receptor-X a eye, dry anticipated demonstrated and dual of models has PL-XXXX retinopathy. the diabetic

treatment started. and product expand We portfolio melanocortin to chemistry. second are drop XXXX. an in enabling haven't half eye formulation by potential studies eye start a IND dry calendar leveraging our PL-XXXX have developed of anticipated as the our worked and activities dry in biology the to of eye in Clinical also We've expertise for

active obesity molecule, active the Melanocortin support of that's X to in preclinical an enabling small activities has developed and of have human human have genetic started. efficacy PL-XXXX number against called IND receptor filing rare IND and models We a studies animal PL-XXXX. orally demonstrated first

genetic filing drug Melanocortin autoimmune number a indications and obesity for orphan We for compounds. of designation anticipate also for

naturally failure in is sponsored in with that preserved Finally first for XXXX. development as potential ejection trial or Heart conjunction scheduled treatment with believe major patients a by We Phase American a research well of PL-XXXX a peptide PL-XXXX a fraction. centers Association candidate the to heart has start X the reduced half

programs as cardiovascular including dual a in going natural and a this is additional peptide treatment of diseases; for on receptor our cardiac use fibrotic fibrotic reduction agonist PL-XXXX for provide information I'm call point, and stop potential the peptide answers. C for and our website preclinical on This diseases. questions is www.Palatin.com Our Thank at to and you. We'll fibrosis. A evaluation in open

Operator

John Newman, come from Instructions] first Our Canaccord will question [Operator

John Newman

Hi there. Good morning. update. And the Thanks thanks taking for also for question. my

you alluded the on update FDA the for to the the time give had also why have blood studies, and that point? So particular just monitoring if you just clinical this know asking about this pressure an was could Carl, us talk at curious data you done you that. And I agency for asked us that in study you is us that think previous clinical remind

Carl Spana

Sure.

for most used week. the I Vyleesi product. probably think discussion, I once as average the pattern use presentation be about the the in the part, to for is going a the That's noted or

was that that their set out turned of small we dosing. a However, there clustered patients

blood was very ambulatory agency it days X and blood In a So in a pressure may with small we of pleased millimeter for our the overall effects measurements a program, week format in data. taken once row think I and X drug X that say blood they Phase in the transient pressure accepted four there week. pressure. using that They Vyleesi was on five or change once evaluated a have program our extensively the in to versus a realized

really It's didn’t what evaluating I days the have going blood patients took we say four have Vyleesi characterizing a we the the if I use what don't we it. have think data we provide determined anticipate happened five when think want if saw and comprehensive didn’t crossing being physicians measuring I's or drug label making that or every that naturally a week, and the job prescribing subsets than to effects to day is it once study characterize can if and on doing. the were dotting that different of or data is a However, the and are eight over patients the and effect. but they're of take there doing and the sure careful. see in its is to they and indication days consecutive anything just agency you drug. There I not that you really the of precaution might non-life-threatening that any I and the patients taking or the T's some pressure

the comfortable term label formal will think that's we to we on short anticipate So don't don't to the putting an the which this study issue, agency were understand it going of in this. will already not characterize product. but that allow a don't anything see over feel will that be seen really or the daily I is the haven't use, effect really appropriate nature I that

John Newman

Great. Thank you.

Operator

Thank you.

will next question Wainwright. from come Pantginis, H.C. Our Joe

Joe Pantginis

the this mentioned out just you from for the clean lead could if study, drug? potentially pressure better label label blood since a Carl, to data this the curious, come

Carl Spana

the agency or of didn't comfortable extent the the or over it the had Certainly, compared absence to put the having have very a it. because data data, cautionary there would exist yes, it with label not to weren’t in on of they

all safe the that highlights the has think that a wind product. up that for label the pertinent will allows I is or use information So the that with of appropriate product we

Joe Pantginis

had act sort it curiosity, data, as just study. Phase granularity reconnect of on a studies NDA the clustering the the use of with you filing, enrolled as the in have patients did describe would that level for this sort did that of a to impacts pressure filing blood the and X had supplement And the that

Carl Spana

Phase general a program, the in X that's more So study.

use type hours. XX over would but We potential it, the patient there of or are So was data characterize that months of and with over one Phase blood pressure to that's dosing cuff using short time premenopausal blood have extensive blood pre-menopause, control In hours. duration almost use general healthy, you through in We use, types women characterize certainly over pressure pressure We that your other not up were did XX women X to the of no for go study XX study. have use, but change over blood were term XX have not there's [indiscernible] different in there hours. signal, We measurement. XX pressure the no were example there them that did patient, over as of daily ambulatory relative effect.

one, patients. high pure be a they an pressure the this density, drug and there was blood that patients daily labeling characterized but be week better I there a subset out enough dosing they when a that looking a of end and we going didn’t we came per and characterize basis at got did just were and looking the think subset with is to those is point will there -- the study of at this twice we in here, So the the as to there use really always that taken the a effect in to is is there or that drug data once probability have indicate not

that We anticipate I based studies what know on answers said, using that appear It's there don't necessarily this the question using formal that methodology to be wasn't based does know, I going previous there effect. is up-to-date study to at that earlier studies. a programs, is Phase As on all. cumulative earlier just and be X that we that any it really poses

Joe Pantginis

to or don't And the to language at my need know the from then assuming FDA I this, is, either this direct body data for clean? regards agents even the last or an this desire point based case if are can you question in them feedback on or from answer the regulatory adcom conduct from the

Carl Spana

a anticipate from will will think an for I XX to you the did -- done not we on January when think there there's no can the not it it's time a to would XX there be. study, I they it if which personally Adcom I that it I based if -- for which Adcom think was if tell would a I study occur we timely obviously submit be for is agency an need fashion, we and What time be I date. be get will sufficient don't don't will there I submit that think with in clean review, -- certainly scheduled and June and think

that. it leave I'll So at

Operator

Ladenburg Thalmann. The Higgins, next from will Michael question come

Michael Higgins

outside some potential the I of you on authorities you if your they that's as in us plan those feedback case your your noted in discussions the happening give on partners am little believe your started Vyleesi, I think surprised when bridge and have Couple for to Vyleesi discussions? those, look [ph]. can if could pipeline. the I half European what's for with of to all and first Thanks you timing discussions Are also your year with still to Q, Great next partnered currently there? The involved then with it relates also partners questions. and taking you the and on PR outside the 'XX,

Carl Spana

pass of get Steve, what understand some very the regulatory to wanted wanted the structure Vyleesi conduct trial in EMA, with that them it [indiscernible] your really like. to is to finalizing I'll accomplish discussions similar a confirm application. American what from and we development wanted trial, to be conjunction for with look the would territory that obviously licensing we any did, to and really the North We marketplace for in then earlier and sufficient single to with the the European market over activities year did to study would of almost had territory. and in We identical to we that the confirm right America be or in North the that for to required we business would we and prior what want start particular, what development studies a thing was around I'll as one Sure, -- to feedback bremelanotide authorities the

towards the end last just have We with got the year, feedback. our of pleased We were feedback.

endpoints in that I think used we were were able to we be conduct a what X identical US and sufficient filing. a Phase trial that would a the using single to trial

really leading turn accelerate that up that since were So discussion to reinstituting the us over to now I'll activity. for is we that he the door or that having and Steve, opens

Steve Wills

the Europe. around mentioned, As was, granularity in we Carl that AI needed approval needed more for specific we specificity, protocol the

dialogue response We now have IMA/CHMP. from pleased the that we Carl as the with were and mentioned, and

not regions increased, AMAG, We're of definitely in and territories Kwangdong Fosun Korea aggressively us of outside America discussions China the actively and Pharmaceuticals. already inbound with has North calls. just also licensed activity all with that with with So the calling, but South

related we date South their the Kwangdong. of China as get I'm closer the PDUFA the working with the rest So Korea regulatory and equivalent also discussions very active greater. specific They existing and world that regulatory our in and i.e. We're advance these partners Pharma and closely to are discussions we Fosun, the path. with will comfortable even same in planning in approval FDI on

the interest territories that We in the before the caveat calendar with the anticipate would the enthusiastic XXXX. and be frankly of and June. with and end all existing excited very were would licensed regions the that and activity we're outside approved assumption So

Michael Higgins

Congrats. May you've the the an well Okay. or that's to that the bullish the not NDA there is that on at critical, Adcom hear the and your as which great, That's early more week in view to we whether experts signal time would what of ahead Last pressure in the agencies Adcom PDUFA? conference the on in expect be identical call without done blood that the suggested U.S. signal, common management

Steve Wills

Sure, vast per very PRN so going is medication, six subset that being by doses to profile. there own will Vyleesi a to a be month that. (inaudible) just risk anticipate our of on the would that a limited have of approximately may per to three patients majority patients have of exposures merits, available that Keep month, think each our a few product in in only times four mind more basis. limitations prescription are eight who evaluated we reward I is times dosing

characterizing falls to pressure have AdCom. clinical advice Vyleesi a risk is I don't So probably and that I out necessarily think an you're would The into low from seek blood effect. agency and where category the go the

think of that I are the working designs meet quite in from potential with using agency small type risk changes personnel changes, intermittent the conversant been that and that study of we've the are the pressure. blood coming the with of we're cardiorenal – group

think that I there. So we're okay

with have will our will The them, choose should back. that has discussions do additional think data could. on do the to right data that based However, that, at so. the -- that, take with we being plan that to moment they to to to I time be don't said, the but for they review they submitting we that always agency have

Michael Higgins

timing, there have need pass will discussion on. you’ll it's reasonable And then or May, timeframe that is just wouldn’t look think the that Okay. a with signal can to requested, for that AdCom that no the you early on FDA, is AdCom an

Carl Spana

submitting. The sure relatively be We’ll a I whether we're agency time be not. getting not decision make I will they timeline in exact date. in am on submission PDUFA of submitting not additional a or advance am major be the and request will quickly to or Sure, into sufficiently that going the

pretty an So I decision the I file don't weeks, data hear what and then that anticipate they're on the time. a to want would pretty anticipate They they can I or towards announcement to moving that, additional is make it's few want timeline on any obviously they communicate in think that I back decision would anything quickly would is if date be going current relatively is one won't would a not PDUFA change grasp. data would the two we wait a be we that. simple, The think to whether long. maintain say And you or it's will you within they there if straightforward, June you and there

Michael Higgins

as follow-up pressure to a from the Just plans that, about press results any in study? this release

Carl Spana

study the the with AMAG's NDA is not, and in is That AMAG filed in conjunction is name.

heavily the the of submitting we although in conduct So will data. are AMAG involved the be study,

So when guided to what we and them to to as statement it, do. would I disclose. they want be that that data some they concerning will up to for will have they by they when speak of can't I but them of the submit them have guess be

Michael Higgins

questions sub-queue on of the expect could if formulations? XXXX, to start I the when grower you report play Couple do time

Carl Spana

targeting probably We're second we're the quick. that anticipating quarter start design relatively and study are

go data long-term They're in those will studies. to would designed quarter start periods, I get XX So we have be preliminary we fourth quickly. the early quarter, studies. expect late first if to designed treatment they day So They're not quarter, second from

Michael Higgins

that, will think it next that's really great. Okay. light, Phase can you on be on maybe point there the results X And I if based

Carl Spana

I broke on missed, up you

Michael Higgins

XXXX, the Sure

Carl Spana

quarter product formal will XXXX in ingredient for probably scale now, for second the that drug preclinical at So we'll studies. sure done active the pharmaceutical and right phase institute XXXX be then manufacturing is --

compound. about half in studies, So I talking first XXXX human expect first you that really

compound. some see that will we will out the put data on You

done. put preclinical out we've of have this been some on model We the date and

we put some second at quarter, we of So point. will probably out to begin some will data that

Steve Wills

Just for Carl XXXX, said of correction, first sorry half study. he quick initiation XXXX, meant that

Michael Higgins

you. Got

we here that due? 'XX, of back on and is final half eye, Sounds on oral XXXX or good Phase plan one X then is the one that dry

Carl Spana

half we So XXXX is in that have that expect eye they to this that's calendar start would is we for drops of are progressing scaled. dry -- year, already and for eye second the and

actually working and area are Boston Pharmaceuticals Ora We they out do. is with of this all

charge timelines and comfortable be feel they’ll they lead us the So with put we helping forward. that

Michael Higgins

Good.

Thanks next of to You or the year guys. get up coming the so, forward news a lot pipeline that. look so over Appreciate time.

Operator

Thank you.

will Joe question come Wainwright. next from H.C. Pantginis, Our

Joe Pantginis

taking know curiosity launch in good Joe about expecting for the say had can potential there? but a you more that question these and Thanks And just do and be the some then guys. all the support to you maybe one? the we're or it's you is even this device ask Hey what if your think approved, but is could supply too timing two, give drug questions, chain get June comments follow-up, early a we number AMAG, turnaround for you could the number of finished the news

Carl Spana

anticipating half calendar Just quickly in side. on second their XXXX they're closely public working with the a supply disclosures, been has very them launch. Steve

it turn I'll him. probably So to

Steve Wills

it's launch, say and As approval extremely the that quarter planning that relationship PDUFA Carl does has whether fronts, in on and date I assuming the when AMAG moving for commercial stated, the fits June that, an inventory. planning disclosed profile. will launching be towards excellent partner. is that Everything calendar of XXXX. success pleased include AMAG We're third commercially is albeit education various with the we towards all Really they obviously that that publicly the have

Joe Pantginis

Thanks a guys. lot

Operator

Thank this queue. time, you. At the we in further no questions have

conference Dr. the to So over back turn I like would to Spana.

Carl Spana

quarter. like XXXX second would in you next you exciting thank look call. for Technologies the the for time I Well We to quarter It's of forward all Palatin to participating company. fiscal updating

for have the going we're excited about We of lot company. prospects things a on and quite great the

day have bye. bye, soon, to talk we'll a you So and great

Operator

very now conference. Ladies at morning's gentlemen, this and this you much. time, this Thank concludes

of have lines phone Thank disconnect may week. you. You a and the rest great your

Palatin (PTN) 12 Feb 192019 Q2 Earnings call transcript