PTN - Earnings call transcript Q1 2018 | Palatin Technologies, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the Palatin Technologies First Quarter Fiscal Year 2018 Update 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 for to Dr. like I’d your today, host Now of Chief Carl and Officer Palatin Spana, President Executive Technologies. ahead, go Please sir.

Carl Spana

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

Steve Wills

milestone, and regulatory, license marketing net the from the digit high-single be responsibility sales, in to million requirements of was digit Thank is collaboration activities morning, develop cost ranging significant received to on first Kong All on and Hong the Carl, license Macau. rights sales, territories Pharma required the Fosun. Fosun to commercialize Fosun sole and the tax $X.X million milestones, which plus $X pay in sales-related X, based pay tiered $X.X in obligated China, China, Starting in upfront agreement, XXXX, approval development, quarter million include: withheld highlights annual will royalties and with announced On of us us also September withholding terms agreement with Taiwan, mainland in regularly and also you, the up consisting and million, exclusive a less good to Under recent XXXX, low-double $XX.X in an with for XX, in we and a accordance payment $XXX,XXX, ended the territory of royalties. of of September we and everyone. signing in China. to bremelanotide is October, commercial Fosun associated

diluted the results, FDA. We Food and NDA targeted Application, or Filing Drug necessary XXXX, first Administration, to period quarter reported of difference is per with and $XX.X fiscal net ended The year September FDA XXXX the results the calendar share, to in for file basic a an XXXX. the same NDA, operating AMAG, and for tasks on year $X.XX between or compared diluted XX, the million share regarding in with loss and activities financial the $X.XX closely the completing XXXX Fosun. was quarter recognition the three in a Drug months million work into license XXXX, with our of continue ended license Palatin $XX.X pursuant basic to with AMAG New agreements the period, per first and the the quarter the $XX.X our of XX, September results, for of primarily to net and million and XXXX, to income during revenue XXXX. attributable Getting financial contract

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

expenses mainly of activities for expenses quarter of FDA, file NDA quarter operating XXXX. comparable an The development million for in of again, with Regarding the for million XXXX to progress the XXXX. were including the September operating compared to continued ended the of bremelanotide calendar was $XX.X for to $XX.X the necessary increase targeted quarter the first XX, attributable HSDD,

net, ended periods related interest $XXX,XXX Total venture expense, approximately – other income for for our expense other of XXXX. September for consisted net, quarter both September was and expense, approximately total ended expense, debt. the $XXX,XXX $XXX,XXX to quarter XX, to XXXX, other Regarding compared the primarily XX,

withheld, in expense tax during ending was pursuant expense, XX, to and withholding be tax as in China, requirements Regarding year income accordance license June fiscal will an Fosun, with $XXX,XXX the the XXXX. with recorded agreement

ended quarter the was and of September credit balance approximately in September in by be other Palatin’s on prepaid current included XX, by incurred remaining returns States currently Palatin Any XXXX, assets approximately For tax expenses expense $XXX,XXX is potential of XX, $XXX,XXX valuation Palatin and income the its as United offset received tax allowance. XXXX. to

XXXX. million deferred and of of of accounts XXXX to were deferred Palatin’s June investments revenue of compared compared September position, $XX.X of XX, receivable million, to XXXX cash accounts Regarding $XX.X cash, cash, Current liabilities at million net September of million, equivalents, $XX June as million million were XX, revenue cash XX, net receivable $XX.X $XX.X as XXXX. of as XX, and investments $XX.X of cash equivalents,

an in resources excellent that least believe fund cash existing We’re operations we through and XXXX. planned to will at year our position, be sufficient Carl? calendar capital

Carl Spana

past the fiscal Thank pre-NDA quarter XXXX and programs. the a first you, Steve. I our will at of with quarter, Reproductive, FDA. Division then activities clinical all completed Urologic with very of pipeline we and year start remaining In the operational cover our productive Products meeting update bremelanotide Bone,

working Pharmaceuticals, complete the bremelanotide Application quarter Drug NDA American we We the for AMAG North New with and first our are filing in anticipate the now to of calendar licensing with partner, XXXX.

done Fosun territory. North deal to of bremelanotide rights granting market closed we with the of context the partnership. outside Pharmaceuticals, bremelanotide of quarter, the exclusive them will a be American in development Last in licensing a Our only China

working regulatory We development and with support activities. bremelanotide are the to Fosun

year for cardiovascular other additional focused natriuretic on from territories, calendar peptide an XXXX, our XXXX. melanocortin first by disease our and program, We potential the have multiple program. of anti-inflammatory with development discussions multiple autoimmune and closing and Palatin’s primarily of others drug are in and fibrotic diseases, partners anticipate year-end licensing efforts transaction ongoing half calendar

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

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

Heart major health remain diseases failure brief need call, problems I So of on provide in treatments. today’s will fibrotic only new a update.

IIa and We agonist end calendar and study trial as the both peptide regulate at preliminary selective when a anticipate the patient superior clinical clinical of natriuretic PL-XXXX by peptide XXXX. of compounds in previously receptor efficacy should receptor, XXXX. PL-XXXX, is natriuretic we planning study excellent has Phase to approaches. to peptide of year-end other failure natriuretic be disclosed, and is by to heart agonist in is inhuman of C plan and a to we fraction demonstrated an allow window to support models for have developed begin activity preclinical and start multiple this a will clinical preclinical enroll activities year targeted with evaluating with broader we XXXX. NP This of can are to system, PL-XXXX that on the dosing ejection that further address PL-XXXX A and natriuretic studies heart indications. begins. will first enrollment much provide that peptide studies efficacy safety We efficacy the planned believe details these patients preserved begin data inhuman dual-agonist PL-XXXX failure We compared A receptors.

initially focus program. focusing In and indications. Our is disease our are program anti-inflammatory autoimmune we ocular disease area, this second bowel on melanocortin inflammatory inflammatory our of development efforts area

calendar into in selective screening and disease we to including of and compound inflammatory demonstrated compound in is needed multiple excited melanocortin development. inflammatory models PL-XXXX all be are XXXX. patients bowel will X a at receptor, uveitis, and clinical the Our agonist trials PL-XXXX completed diseases, efficacy year-end moving the PL-XXXX movement activities, to anticipate the by that the preclinical be first has support clinical study we clinical has

development at area receptors. Our X candidate both melanocortin is PL-XXXX, second in which is X an this in and agonist

disease drug potential the activities the strengthen plan indications We begin natriuretic peptide compounds studies. data targeting will resources the has We to should potential expand our supports that us to continued the our that of believe currently in PL-XXXX which required intellectual and file We If are peptide start systems discussed a models PL-XXXX above. development and multiple beyond melanocortin allow evaluating in of to we activities property. clinical the to studies allocate IND, XXXX. safety to indications and potential plan of preclinical

of to multiple partnerships, only to impact us our lives better future success access of with pipeline without significantly about the and we markets our commercial our I’m potential through the provides company, value potential excited unlock not programs programs, trials can in clinical the think have realizing this having III to that The bremelanotide, treatments patients. and capital by concept I of for the the new the to development lead value for bremelanotide As the had very Phase provided developing of funds. in resources

New the bremelanotide Pharmaceuticals, FDA approval early first potential AMAG we’ll Looking Drug working North with aim XXXX. American put file commercial achieve following and on of with forward, us to we in objectives: This partner, for complete XXXX. track be to our bremelanotide will Application the quarter by the the diligently

In we in be will in support of Pharma Chinese working with to bremelanotide their the Fosun activities development regulatory addition, market.

with development America business and Our EU, focused partnerships will the on bremelanotide territories. primarily activities Latin other be

into stakeholders. business I formulation, complete objectives start following on PL-XXXX has preclinical And II system, preserved value studies be to this for PL-XXXX natriuretic peptide development to in and initiation begin heart ejection failure diabetes required with to IIa study we Our building a the objectives: studies. submission employees fraction. and proof-of-principle demand for patients corporate an achieving activities of has PL-XXXX for And I objectives: clinical Phase begin required have to peptide ongoing, Imagine melanocortin XXXX. activities program oral begin with And XXXX. of PL-XXXX studies, IND Phase clinical will entering the of XXXX. for our system in goal to program, preclinical the a study to and And Phase following collaboration. of first studies complete Phase melanocortin for program our of efforts in Establishment obesity Palatin our focused completion

at you I said Thank the palatin.com. on call more website We’ll As a reminder, open questions. can information now you. our to get previously, as

Operator

first we’ll Canaccord. And question Instructions] Newman our [Operator you. Thank John with from take

John Newman

providing some the you can bremelanotide continue the the you’ll be plans the talk wondering, obviously, morning, submitting launch time, approval. for in guys. have early about for to market to Good Hi, I’m that thanks year. today you’ll and FDA all I next information prep if before your XXXX. know update. But filing

focused be talk should things on can the of during you if curious that Thanks. Just time? that type about

Carl Spana

Steve closely for really handle let most I’ll activities. more AMAG because that those with Steve? since of he’s that, one, AMAG Sure. on is responsible working

Steve Wills

John. Hi, Yes.

can various more behind being items are to And As say, you enhanced done, coming the to you advancing AMAG and scenes to question, is our in, the actually just education and nice I I is sure a Carl with the NDA mentioned this Carl many preparatory for of care and No health informed activities, parties the mentioned, there. and at as What forward obviously earlier, the XXXX. the patients, can and an tell first on in right working show pricing. reimbursement we first quarter. way are really is the definitely and going launch this as the program mean, patients, make Other just calendar the launch. attractions, as the quarter regarding see there possible now, also filing when, landscape, approval AMAG. priority providers treatment, educated out this efficacy That anticipate third multiple with moving get the in

John Newman

just you confidence can that PL-XXXX, looking program to to the see to in to things the see what you that order give continue forward? in bit And little like the you’re Thanks. to a – push maybe you’d about of types Phase trial great. IIa Okay, or talk

Carl Spana

today, FDA-approved it’s a it’s in – Sure. patients that Thanks, There see. ejection of in really This product. fraction. to looking John. for aware, failure number a things no is with as those ejection of fraction, that aren’t that importantly, preserved heart have study, preserved IIa we’re are And has

represents it failure largest So untapped the probably market heart space. the in really

which So this a two is types study dosing looking really a are of we single study. in It’s for parameters.

And wedge one, secondarily, in these biopsy. hemodynamic pressure, and be that patients on measure capillary we will clinic looking a cardiac our other setting. can having the effects properties for pulmonary we’re So

that is tissue forward that patients gets that i.e, looking its and system that evidence there all compound the lot ejection preserved hitting is a then that the us on a peptide clear patients receptor signaling downstream able functioning we’re normal these That normally, cardiac it’s a pathways outcome. and have really are will have we fraction, way. the and long-term in be basis positive in, the of what natriuretic So in potentially confidence to functioning should give a treat that

we’re that categories broad two data. the looking really that’s for So

good of kind and no patient is this that population for these we and interesting again, really said, has see being and patients it lot and system products a working to think look a do is very with get So their are because an we’ll disease. that essentially to there of potential and it impact mechanism has important get in this this study, potential FDA-approved

John Newman

you. jump thank in back Great, I’ll Great. queue.

Carl Spana

thanks, Great, John.

Operator

question And Capital next we’ll our Roth from with Michael take Partners. Higgins

Michael Higgins

everybody. you? morning, are Good Thanks, guys. How

Carl Spana

Pretty well.

Steve Wills

Good.

Michael Higgins

I Couple could. of morning questions this if

it to the U.S. and relates views Europe. First, as in the regulatory

I about you talked similarities, bodies Thanks. that for? give in again? how two think what differences the I of kind us think, looking looks potential regulatory just, are a you those summary of,

Carl Spana

both the I’ll Phase was, We data placebo-controlled of with those FDA provided III and them process. the trials Obviously, significant we’ve both outstanding. with standard protocols. reported, Sure. was review Look, has studies identical clinically There tell for you. very launch to studies. statistically a FC two randomized as

they as replicated they So we would. hope

In excited a extension. that. amount longer-term and a obviously of open-label is data. So provided the safety second, We we safety there we’re provided about fair safety

the the really to the was with will basis Phase as the EU, that’s evaluation and in discussions FDA. the had the for the support start U.S. for III, a or them So approval study what a discussed core safety efficacy marketplace have acting single efficacy with The and discussions, of studies U.S. U.S. those by in be the and of the prior approval. we’ve for EU we doing what

there both or review submitted argue do women pre HSDD, little is any experience and where of both we have position requirement EU are the their separated. The difference to and approval that necessary point irrespective is would can or post-menopausal an if quality updated HSDD, and and only post-menopausal. they they what strength We’ve how think they post-menopausal data. support indication which see status, women then that looking HSDD we the really way U.S. single and there with treatments for be I of that board to for really do for a that strengthened whether of women, are we’re of not is we that and by and should to in respond pre is would there’s the study real a pre

Now one approach to meeting with push first whether grant that’s we’d have or that we’re not the we quarter going of to we’re that, don’t know expect when but the occur and for they’ll which the XXXX. that us a we that’s in taking them,

Michael Higgins

back And of will could. outcome size if of Thanks. the in your then a that follow-up as going to on just the what on that be? one, us how I next meeting When would trial? that And you get expectations to

Carl Spana

lighter. European a than having That be a anticipating bit be doses it’ll two would can population little be bremelanotide, larger were trial, we a since the single of –

So there will be women. lighter weight

So milligrams, dose or are the we placebo having milligram. lower X.XX anticipating order X or and a somewhere in X.XX

in regulatory around in EU, be – timing strategy if the our subsequent development of the regards on update With that’s quarter arm So the to so, and any be strategy total. follow-up per the on or in and patients really with XXX anticipating you’re that XXX will patients still around first outcome required. dependent to meeting regards

first I say or be the quarter hear that earliest would – or on first you’ll So late the would update. from probably quarter us probably around

Michael Higgins

penny the many point? warrant outstanding this I thanks. on and Okay. are stay at quarter situation, That’s there update an And think is helpful, how Thanks.

Steve Wills

January Michael. $XX with started beginning of the million the It’s approximately We year, those warrants. Sure. penny Steve, prefunded of at so X,

million, year. down the we’re be to by my that’ll that and today, is of end $X of expectation As the $X approximately

Michael Higgins

great. Okay,

that we think calls, data PK potential an by I us give You bremelanotide Might for that? you can see in on year-end. update the had Thanks. if mentioned, previous

Carl Spana

And a more me been that In give detail something PK you for maybe Bremelanotide has Can on little context? said I I established. that that? data previously. missed has – been what

Michael Higgins

liability, year, drug – was cetera? Sure. there some There et data safety abuse PK running I this were you think that interaction studies additional

Carl Spana

Oh, sure, sure.

sorry. Okay, yes,

I that think would submission. studies NDA support there various eight the were

various of depression so drugs liability of They beyond pre-menopausal completed. with abuse oral range that so contraceptives PK and types drugs, women studies, a that All population of interaction have on been and such from those analysis as might forth.

that out were So to specifically, are indicate they they I support we there any – clean those study that, studies, it is a a but a Abuse label nothing report. ran, broken interactions really didn’t of interaction see that all haven’t very they liability really, they drugs program, study uneventful. with no good. looks mean, should be drug clean there any quite great standpoint. is from We any

a So at we very label. are through to bremelanotide nice go really expecting

Michael Higgins

right, All okay. guys. there, it. surprises appreciate no So Thanks

Carl Spana

you, Michael. No. Thank

Operator

That at or closing you turn I’ll time for the this any Dr. concludes Spana, conference to today’s back question-and-answer session. remarks. additional

Carl Spana

everyone. was really you, thanks This Thank call. participating the on – for

lot for As on expect and always, really the we’re year. outcome a a Bremelanotide is of to forward end quite approval the enthusiasm clinical we from the look of get we seeing now cost earlier the we trials moving really really year. excited about And excitement. submitted And that. Palatin being programs next very positive as and

So a to can forward for capital And having think it tap tap without on lot I us. move the markets. we

and call. thank as and as of you forward you really being throughout next day. the updating to you Look quarter we the So have on always, course the a well. updating for Thank great you, quarter

Operator

concludes This We conference. participation. today’s appreciate your

disconnect. now may You

Palatin (PTN) 13 Nov 172018 Q1 Earnings call transcript