PTN - Earnings call transcript Q2 2018 | Palatin Technologies, Inc.

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Operator

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

As a reminder, this conference is being recorded.

Before we begin our remarks, I would like to remind you that 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

welcome and call. and Officer. we Spana, Palatin’s Executive Good fiscal Chief the call Palatin; Operating and to President, operating Steve Technologies on provide Palatin will morning, Wills, is second with year me XXXX call, and Chief I’m On CEO Carl Vice updates. today’s today Dr. financial President of the quarter Financial Officer

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

Steve Wills

entered XXX,XXX, received sole license the withheld Macau. Taiwan, payment of we develop digit on cost royalties accordance regulatory in is sales-related Thank license consisting quarter XXXX, on you, to Hypoactive digit associated requirements rights first development, which female to also include: terms be million double on a royalties XX,XXX million royalties. China. tax withholding in hope from October and is the activities pay approvals in based the low-double significant operational to Carl. the Good of commercial regulatory territories license which morning, a and everyone. from X.X associated November an with All milestones, sole the with with X marketing us on to agreement, for highlights which regulatory, ended and tax the Sexual of of commercial is pay obligated a all September digit the Kwangdong Kong, Starting upfront the Fosun. Korea. milestone required XX.X us commercialize and activities Pharmaceutical of with South pay sales-related to received tiered digit high-single in China, tiered development, high was Kwangdong sales million XXXX. Desire pay be the financial the Fosun at marketing in and with X.X in territory XX.X agreement, annual remaining Korea. have in net second to us is exclusive million We Bremelanotide, and million in year based development of XXXX of Under less the Kwangdong sales XXXX, accordance territory and Hong Kwangdong. also in in ranging obligated Fosun net respect sales, develop Disorder XXX,XXX less was in and will to calendar December consisting sales, up annual territories milestones of is licensed of requirements sale with to XX, responsibility costs to us up withheld commercial rest also end mainland in XXX,XXX required into upfront to under South rights agreement In China, the in an Korea, will recent to Shanghai for the to announced million, by also the Pharmaceutical Under HSDD. Republic $X XXXX, commercialize we payment exclusive bremelanotide Fosun signing bremelanotide of licensed single the December of milestone we In and ranging low responsibility a world agreement terms of in the for the we of royalties, of withholding

month. targeted activities our with Pharmaceuticals, by file and are end We diseases, new new initiated the human drug dosing working received of this filing Colitis with to America, a FDA. by licensee we this the for quarter. AMAG our an on in necessary and for Melanocortin Receptor completing subject the under is With investigation clearance is respect X AMAG IND, earlier Ulcerative the FDA PL-XXXX which a development program, application, closely first North bowel to drug for of with Agonist for application clinical FDA NDA study inflammatory

our to over results. financial Moving

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

December million Regarding with I related XX, quarter XX.X entirely for recognized recorded quarter revenue in agreement stated, the as license consisted ended license in There no revenue contract and XXXX, AMAG. we ended which revenue the to license the XXXX. December and of XX, our was contract revenue,

ended expenses cost operating quarter XX, million, attributable we as advance lower AMAG to Regarding comparable compared NDA being the for for mainly $X.X The XXXX. bremelanotide was program December stage X.X in by the total expenses, decrease were our for operating operating of to with expenses towards the FDA. million the filing XXXX quarter development

XX of least receivables June XXXX, our September XXXX. cash million million net million, position revenue $XX working were of expense of of XX, Current and resources related that months. XX net liabilities $XX.X million debt. December be to for Carl? XXX,XXX XX, XX.X as equivalents other XX.X cash other deferred of December ended expense, cash and XX $XXX,XXX for at XXXX, planned million December deferred will XX, and income capital at deferred million Total the June venture net capital fund the X.X of interest net of We accounts sufficient $XX.X as other XX, next total at Finishing primarily net XXXX, of of existing XXXX compared quarter million, of were XXXX. the our million, XX, of ended of compared XXXX, cash periods and million XX.X expense and revenue XX, operations expense, XXXX. at cash, to to quarter Regarding to of through both compared with was consisted December and XX revenue Palatin's September as XX, believe to our equivalents,

Carl Spana

quarter I’ll you, fiscal XXXX update operational our start Steve. Thank second year with bremelanotide.

quarter As drug a we're putting application new partner our we Steve calendar said, now bremelanotide in anticipate new AMAG bremelanotide the filing on the with North licensing track drug American and potential in XXXX. XXXX pharmaceuticals working complete a to approval first for of application to

we partnerships. of to Kwangdong will licensing market outside our American South bremelanotide be the Last done excellent American with closed granting second them in bremelanotide of quarter, development exclusive only in Pharmaceuticals deal North context Our of Korea. right

Pharmaceuticals and partner regulatory We with Fosun are development activities. actively in to our bremelanotide their Pharmaceuticals, support working Chinese Kwangdong

We licensing additional focused have discussions are transactions anti-inflammatory drug other partners different or peptide ongoing cardiovascular multiple on calendar our Melanocortin primarily with naturally and bremelanotide and year Palatin's XXXX. development program and for anticipate our potential diseases with and in closing territories efforts fibrotic autoimmune program diseases.

rare of development designations. of life-threatening diabetes orphan including disorders Regarding pursuit in our and reviewing melanocortin the business drug assessing we our strategy, for in metabolic deficiencies resulting genetic development and obesity treatments program, are

and of Our faction science website methods our descriptions www.palatin.com programs, has detailed potential. including commercial supporting of development

call, So, only I provide update. a on today's will brief

and bowel was by models the In melanocortin XX FDA. This PL-XXXX that drug Our of XXXX, enroll PL-XXXX and in PL-XXXX In agonist This to new complete and ascending the clinical the for moving approximately of single content we study. will study the we has application quarter expect fourth ascending quarter began into subjects PL-XXXX to dosing including we multiple our study inflammatory uveitis, diseases, first pharmacokinetics is multiple accepted efficacy XXXX, of compound are subcutaneous X development. combined XXXX. a in study be the of the inflammatory disease receptor, third for a demonstrated at selective in excited and evaluate quarter investigation dose the healthy subjects. will and in safety the

PL-XXXX we calendar later into addition, formulation developed clinical this an formulation move plan In to of and trials have this year. oral

X studies. continue second we and to file PL-XXXX. in IND. the and the required development disease are drug supports evaluating candidate start currently If is X agonist development, to It’s multiple an Our plan receptors, an and we activities melanocortin melanocortin the safety models data at pre-clinical PL-XXXX

cardiovascular in these problems area our is peptide second focus Heart health naturally treatments. of diseases. fibrosis failure major for and program Our new diseases remain fibrosis in

when disclosed, We indications. patient potential heart to fraction. details that we clinical multiple the peptide will start begins. the in previously compounds study naturally And further planned be patients PL-XXXX study will XXXX. is is regulate PL-XXXX efficacy the naturally these a have at plan year clinical failure in of developed can evaluating that This on this and receptor. trial safety calendar systems Phase as And address provide agonist enroll preserved ejection with peptide A to selective we enrolment that Xa

is the peptide activity demonstrated PL-XXXX models agonist compared PL-XXXX broader receptor and believe failure. dual PL-XXXX. an other dosing the the should receptor. agonist Our of We A of approaches. for a second It’s window, much naturally preclinical allow peptide efficacy excellent of heart both NPR compound in superior to NPR naturally C efficacy has in

also We to We indications believe additional that activities has to being potential expand potential activities clinical strengthen peptide intellectual plan studies. potential melanocortin indications allocate the discussed human naturally first peptide our pre-clinical to and our begin above. and compounds support that to planning beyond the are We of systems resources charge property. will

our about in you of has programs As The the with for commercial excited impact and trials of bremelanotide to capital Palatin, pipeline unlock I had in provides very the to it value provided of resources could our clinical developing realizing the the phase programs have to treatments potential from of significantly resources access value lives to the development future we markets not concept without have the us patients. partnerships funds. lead now through multiple the think to success that only having bremelanotide, am by new

we achieve following forward, the objectives. aim to Looking

and our bremelanotide in This working first potential in XXXX. complete the XXXX. North application We Pharmaceuticals, us bremelanotide the will to track be or with commercial new quarter drug FDA AMAG approval with on put American of diligently the will file partner

primarily will with America, working In regulatory be with the support Kwangdong EU, partnerships territories. will addition, their bremelanotide Latin be Pharma development our in to Fosun on focused other and Pharmaceutical And development and business activities we activities.

the initiate to oral studies. preclinical complete dose multiple Phase the program, following complete finally, And failure are ascending for into patients first move the melanocortin PL-XXXX IIa system are with for single ascending, to of our initiating and and activities ejection programs human required clinical objectives peptide clinical natriuretic our PL-XXXX fraction. peptide in studies to preserved X and heart For our in study study begin looking the Phase to formulation we

our for stakeholders. and end on focused the As employees achieving call, be we our will value the Palatin and objectives management of building

these As find mind our Thank you. at information on we www.palatin.com. and more website

will call to open We questions. the now

Operator

Thank We’ll you. to [Operator first Instructions] go Canaccord. Newman with John

John Newman

morning. guys, Hi good

it compound, question had PL-XXXX, on think for that just Just designation? a if particular might fast-track eligible be on curious you

Carl Spana

if that There call space discussed really rather naturally some designations on by don't the is actually conducted designations is the rare often one for or John. XXXX. I compounds peptide I a think study The short it third-party disease is, That sensors. has the but that compound, property older in compound we I is may and that our by that with be life. compound know intellectual might be would designation, really fast eligible and it winner track being it’s of follow funded academic the is

particularly much a to because that background we be see clinical other we're to of the we smaller other looking certainly some able are repurpose I - we - for. better that associated PL-XXXX it peptide. be we But may regards if on. with I have potential may said, with the That's is natriuretic orphan certainly close effects some ones the may indications really of hypertension as profile that one focused to think side and some there are with

John Newman

time, a at expect to On this profile, in but know an have have as you just there? you're Okay. curious I thinking to point you bremelanotide, do how panel FDA

Carl Spana

Sure.

the process planning with to and they advisory We agency they the first-in-class were planning will in have did, a is tell NDA. that it the compound discussions an be meeting us for - pre-NDA our

John Newman

great. Thanks. Okay,

Carl Spana

Thanks, John.

Operator

We go next Higgins Thalmann. will to Michael Ladenburg with

Michael Higgins

are how guys, morning Good Thanks. you?

Carl Spana

Good morning, Mike.

Michael Higgins

is you’ll questions stage relatively everything what of please your I is right signing Couple in pipeline, your for outlook pipeline those pipeline, Would on lot of on if partnership with a three a and be II? next go could, some your partnering sooner maybe Phase holding the thought? years have partnered the post the

Carl Spana

is Mike, compound I is for quarters targeted strategy the XXXX, to next over personal to going think the the going that as into ulcerative several emerge the colitis.

anticipating preliminary that We’re will for but that first the and that formulation a oral few continued licensing on approach. based talks, now. systemic in have hurry cash have with doing not currently up success we’re Certainly, to position flow a had from additional bremelanotide compound pipeline we followed an the now, the partners, any be right of the that with close cash we we’re transactions potential licenses and discussions on

I substantially value programs can in we drive more think built a little bring can those more partnership. we before value, a at be

you those will indications the of own. what to some haven't the yet to to be more patients. development where potentially through think or or of take four ocular two talked such pathway is on And I haven't quite us require there is focus on doesn’t we can straight-forward little our really like do we next Phase see some the bit quarters it attempt where over being much eye X the cleaner, begin may orphan may little a many the we - be indications that bit as dry disclosed something some designations pipeline about

projects, own but some and the the right you ones additional partnering business where So, now the look we concluding see that of be of a bremelanotide rest some world in will really certain while bit will focus we partnerships following pipeline. on the little we forward the main the built with efforts earlier, development value take of our will on mix

Michael Higgins

yet, bremelanotide. what on to that updated That’s Any your from thoughts, want discussion? up haven't hearing helpful. your partners on your you just partnered Thanks. you're last I are areas other dovetail for what comments

Steve Wills

it’s Michael, Steve. Hi

the year. end with not I the rest are comfortable the pretty that anticipate having of statement We’re the territories world licensed made we that of by the currently

excellent in Asia-Pacific, basically all EMA, some Japan, i.e., have America. We Latin the territories the territories i.e. larger interest remaining

quarter. they advancing are even I that we So, right filing we post now, AMAG this the - again discussions accelerate would by and would as those anticipate NDA later

Michael Higgins

queue. helpful. Thanks back Okay, the in jump I’ll that’s guys.

Operator

no And the back at are Spana. there Dr. turn this call questions. I’ll further time to

Carl Spana

call. to end for Great. throughout quarter. We quarter look getting everyone you and Thank participating at you quarter updating second the the meeting of our on out next and forward

have thank great and a you. day So,

Operator

you We today's conclude does for thank This participation. conference. your

Palatin (PTN) 12 Feb 182018 Q2 Earnings call transcript