PTN - Earnings call transcript Q4 2018 | Palatin Technologies, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the Palatin Technologies Fourth Quarter and Fiscal Year End 2018 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

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

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

Steve Wills

Carl. with financial fiscal significant and morning, with I'm you, Thank XX, recent and Good start everyone. highlights, the fourth XXXX, June ended Starting going quarter and operational to year Vyleesi.

Palatin approval. would in If receive women of a of review also of the AMAG. March triggered The XX, acceptance the is bremelanotide name, entitled was Pharmaceuticals, XXXX. Act acceptance notified the Desire Vyleesi States. filing Vyleesi, in treatment name regulatory Now indicated the and for milestone United United approved, pharmacologic and NDA HSDD Inc. FDA our Hypoactive June Sexual New million The States option for only the the for $XX Drug official under of which upon payment completion or FDA for Food North Vyleesi by first to of $XX Administration The become which HSDD. date In milestone exclusive AMAG is Application Fee Disorder the on-demand expenses Vyleesi. premenopausal XXXX, trade for User payment development by PDUFA The for Prescription less Licensee paid is the is trade FDA American the million FDA's a is NDA the goal to Palatin, Drug for of Drug

Hong China, fiscal the Pharma I'm of commercialize with of payment sorry, an less we $XXX,XXX mainland million -- upfront to payment June entered received We $XXX,XXX. of license exclusive the XXXX and XX, for territories and Macau. upfront Vyleesi Kong, collaborations an a taxes Fosun in Taiwan, and of During into taxes rights year, agreement $X less develop

a agreement exclusive rights and payment, $XXX,XXX his taxes. the the Korea. for entered Republic We to less with on license Kwangdong a received Carl of also in during Vyleesi $XX,XXX our of upfront are We we into expand commercialize will advancing programs other of presentation. part develop that Pharma

the year, this Regarding to other years, XX, from ended done fiscal Company's the corporate, during grew June June the several XXXX and Russell throughout XXXX, with the and portfolio debt issuances intellectual to property Palatin in XX, year million $X.X filings XXXX, year. XXXX decreased in at June Index million. added we prior we was we've $XX.X as

results, XX, of XXXX diluted to June of the for for $XX XXXX revenue ended to ended recognition share contract for fourth financial in Going ended approximately compared into XXXX, the results, specific Palatin The the and XX, AMAG quarter license three with our XXXX June of period $XX million the to XXXX. primarily between in the was agreement difference same XXXX. million compared of months attributable pursuant approximately income June fourth fiscal $XX.X $XX.X XX, regarding quarter per and share $X.XX our $X.XX the or basic quarter million to reported per XXXX net million income net year financial basic or and and diluted ended

revenue XX, net $XX XXXX, year ended the per The primarily recognition June was to $XX.X and loss a approximately net XXXX, -- loss the period, XX, of $XX.X of million, XXXX, year ended income XX, net XXXX June compared For diluted million ended contract compared XX, year for recognized net for $XX XXXX. year share and June the the in the the to income this the fiscal share XXXX, $X.XX XXXX and compared year and attributable per XX, million year ended in to is June million, operating year, or the $XX revenue $XX.X million and basic ended Palatin June in million expenses for license year for June of $X.XX basic the decrease million as June diluted ended reported June ended again, XXXX. the XX, the XX, for a to year secondarily for full or to ended $XX for to in the difference XX,

Carl? million, $XX million I'll $XX and net million September the million sufficient of XX, through to Palatin over Carl to of Current back June that, XX, capital be resources at as our Spana. revenue to turning cash Palatin's call and planned million working cash June June fund were existing be investments XXXX. equivalents of cash believes operations least capital; to compared liabilities and XX, $XX.X With cash Regarding Dr. position of million XXXX. deferred XXXX, XX, $XX receivable at $XX.X cash XXXX. accounts the at will $XX.X and of compared and equivalents were

Carl Spana

product. only hour self-administrated lead Thank complete single-use first-in-class you, drug Steve. Vyleesi subcutaneous the simple, Vyleesi, on-demand update operational I approximately will patient melanocortin to start formatted is as a Phase clinical prior activity. Disorder. X agonists sexual product Sexual a one clinical for is which auto-injector, with Hypoactive The trials by to the our Desire is the

Vyleesi. regulatory support FDA toward and AMAG for territories filings. Outside in was with FDA XX, licensee, early with NDA working South for Fosun our partner licensee The Vyleesi by completed new our XXXX. March advisory prepare We're we meeting working PDUFA AMAG in the advance Vyleesi and discuss application hold in to meeting. June. Pharma, are Vyleesi date licensee, America, XXXX. We to currently Kwangdong in the drug with Pharmaceuticals to NDA an committee and Pharmaceuticals, development drug working Chinese which advisory Vyleesi our is Korean North AMAG Vyleesi, been for the the reviewed committee acceptably the the North to plans March The to to new American XXXX, of those for a submitted FDA have application NDA We

territories. also In addition, with have for multiple potential we ongoing partners discussions other

inhibition our drug X-receptor two broad programs, rare fibrotic primarily that peptide program with diseases. we're Melanocortin Melanocortin of pro-inflammatory earlier Activity focused X-receptor variety down which inflammatory We've of has eye, on development Now and of agonists agonist. in interest are maybe genetic moving and the inflammatory B NF-kappa with a bowel treated developed highly diseases controls A second selective X-receptor which treating cytokines. to including new by dry immune and Melanocortin forms regulation on system broad natriuretic inflammatory in and applications our therapeutic specific areas autoimmune of obesity program, in rheumatoid families and diseases, of arthritis. of and disease, autoimmune Palatin's Melanocortin cardiovascular and uveitis, potentially for area of disregulation interest

and Melanocortin broad development believe clinical inflammatory application we lead and treating has which of will animal is diseases. Our inflammatory demonstrated PL-XXXX, a compound, autoimmune highly X agonist both reversal disease have X-receptor PL-XXXX and selective Melanocortin autoimmune models. potent in

and developing of PL-XXXX. oral are both formulations We subcutaneous

third Our XXXX. the ascending in a we single unblinded Phase PL-XXXX has of completed subcutaneous have multiple formulation of the data X dose to and ascending quarter expect study, and

studies a evaluate to X Our to that to Phase diseases. next the first data needed in This variety is study is is a the of of start step formulation and PL-XXXX to support of conduct quarter the larger safety efficacy autoimmune provide in study will Phase designed anticipated with and activity subcutaneous XXXX. the XA

oral XXXX. formulation start potential and fourth for Colitis, of Phase of the quarter study is is treatment development to PL-XXXX a X Our in in Ulcerative as pharmacokinetic a scheduled

agonist. ocular treating for dual development under eye is inflammation candidate drug disease a PL-XXXX, Our and including receptor-X X dry Melanocortin

and eye formulation studies potential in shortly begin a expand developing to in to We product working thereafter. of as chemistry. Melanocortin pre-clinical-enabling anticipate are an and IND file by treatment with We've PL-XXXX also clinical completing expertise portfolio our our for dry drop leveraging eye. PL-XXXX We and activities been XXXX biology

We resulted Melanocortin are has has patients to X-receptor developing the with small of molecule, as that in pathway number of treatment qualify rare potential the a designation. PL-XXXX. drug leptin first in of may orphan orally early initiate safety PL-XXXX filing obesity believe support with indications and life-threatening disorders. the a PL-XXXX human an of to onset We in We obesity. PL-XXXX in preclinical a for melanocortin PL-XXXX IND XXXX, with agonist, animal efficacy plan genetic and models studies potential for clinical demonstrated number mutations activities half active,

other Our diseases. peptide fibrotic has been focus our system naturally area cardiovascular both of programs and for

suitable Association peptide that and that heart maybe in believe that therapy replacement as a receptor a for in pro-hormone processing Heart preserved X is naturally and a in with peptide lead A Our potent use developed We agonist both, of deficiencies. fraction first C naturally It's the has peptide for patients also and the diseases research Palatin sponsored XXXX. candidate, scheduled this for data selective year. the centers to is agonist later expect XA major pre-clinical and potential next has we fibrotic year to patients both have our and This failure and naturally in early a development reduced PL-XXXX studies evaluation, A fibrotic PL-XXXX trial is reduction of including or half ejection treatment cardiovascular cardiofibrosis. with peptide, PL-XXXX as models in in start Phase or peptide American juncture Phase a completed by is receptor. a

we progress fiscal find on information As In a www.palatin.com. you on made programs we our of and in can our March in the anticipate approval Vyleesi XXXX. substantial programs additional development advancing website, reminder, our XXXX, year

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

to AMAG Over the new working we on-track the we'll Pharmaceuticals Vyleesi Vyleesi prepare diligently next advisory XXXX. committee XXXX. to year, early drug following a FDA potential be and support remain the with for approval And in we application, Vyleesi March objectives; for in have

Pharma will Pacific, to regulatory work other Pharmaceuticals Kwangdong development and primarily America will activities, and Latin In on addition, focused partnerships be selected and business the Union, support Vyleesi our we and European activities their territories. Asia for with development Vyleesi Fosun

formulation would study ejection initiating study in For program, the with the naturally failure to complete complete objectives; main oral our our our And heart has to XA patients Phase formulation and with really system our PK melanocortin preserved program initiating Phase PL-XXXX XA Phase objective for study. for for following fraction. initiate X system our to we PL-XXXX to to the for subcutaneous Ulcerative Colitis, is like peptide our

our orally or disease, focus required first agonist The and PL-XXXX, initiate Palatin human management achieving to our the For to MCR-X more the I'd call. initiate active building PL-XXXX activities. our like over for can And we our to And at shareholders. molecule, and would the website can't you as like for detail a all R&D operator small begin programs employees and complete turn treatment now remind I'd receptor the to objectives lot and open activities you enabling for development on Thank we of questions. www.palatin.com. finally, these a value remain it that studies. for dry eye our find pre-clinical at for on on studies to you call up participating

Operator

first Wainwright. comes H.C. Our Pantginis from question Instructions] of Joe [Operator

Joseph Pantginis

or status upcoming any go? prepared of issues are or that need or -- the AdCom, regarding First, any outstanding still I'm ready see things to sort and to sorry, quo things potential you be do

Carl Spana

the We'll minute. ready be being until AMAG last on up with working

anything I I said, were agency, the request we anticipating. information the being that think been has review and think – on going with really review that’s highlighted our not with that the

will know, panel their been you so sure As that we'll compound, rigorous we probably I'm meeting Vyleesi will have be be will -- very FDA well-studied do prepared, prepared meeting, expect job, will but that. panel them or AMAG to they very a the be with and the and a has we do working

Joseph Pantginis

be how about in the have drug? March is indication then, they might approved that to might any assuming you the launch able received drug from the there quickly gets AMAG timeframe, And

Steve Wills

drug launch so is to thereafter, the quarter. second immediately target is the plan The the

the we working stated Let's things of launch -- to of can possible, calendar it approval AMAG would as quickly final and -- in is to us labeling, again, targeting is date both that as the have and that nature and quarter PDUFA March out be soon of that we've XXXX. able as XX, be as second

Joseph Pantginis

one strictly And last regulatory? done to Kwangdong quick then clinical with Vyleesi, work it is on one just to regard collaborations or Fosun be Any or needed

Carl Spana

to just planning Vyleesi Asian in X the Those are pharmacokinetic a them predominant and North confirm Caucasian the that of study done of and the approval America to Vyleesi is, absorption population to the to the both in U.S. metabolism think of Phase I do is same study file in in be it trials. time the population of off the as the would

Joseph Pantginis

opportunity the have to lack here; to of a opportunities will. broad if opportunities no pipeline you have so riches set You of with pipeline regard

additional So data? to to I well look investors guess, as driven you are or opportunities these you these you've looking of how to being into orphan everything that all going for the by with provide just as discussed even focus indications, basically are

Carl Spana

these fairly as stage, data are. we always by the early would we since are definitely at think be I programs certainly driven

able drive on just that's too our very And an I much have heart most us phenotype a products think looking failure broad that we've -- as of or won't been the active, in in We're that in indications. preclinical doing the take various for a PL-XXXX see distance have the quite us and will rescue those in really that molecule looking melanocortin in and really for really the mutations orphan to area we space, where the with the forward the indication. leptin lot some the -- substantial our we've work in one nicely. part, autoimmune resources of models mean We're we're melanocortin at some where quite large the focused -- pathway, the -- been active work path excited orally of I the indications an and fall diseases too own X-receptor with forward that's first of to and can you in about small of we -- Company. the the autoimmune with

younger think because of is more and that and nicely oral population. nice injectable compound a quite these children place patient many optically a that So little are what are have difficult, there that in very but -- for these are compounds I patients works you

next of So, that's of progress the as you've on these make is sure we the a year lot we have and the drive which for really really through X really the things data into starting us studies. required one decisions said, but to making larger Phase opportunity, really will

Operator

from Our Instructions] Newman comes question [Operator next John of Canaccord.

John Newman

what -- about wondered is, under you some with market could now, Obviously, FDA as review, of and review obviously us sure terms what can just the do but bit for to option Vyleesi I you we we to could that that in still of know are start aware is that talk that just if you their that of physicians restricted drug but I prep the Vyleesi realize you're are doing patients? be moment wondered at the if you're an some you do that to a that it curious things make under allowed is might the to

Steve Wills

everything much lead has or pretty preparation. commercial and commercial potential that I partner mean the the commercial AMAG behind the being preparation obviously, taken regarding

and you the concentrating and they now, primarily running HEPs; the through on Vyleesi/bremelanotide of and AMAG right will right to with websites consumers direct several targeting they go have HSDD. you up the education, now, website, actually and As if it are

data at this think appropriate, we're doing So, presentation and around primary and some education conferences, has the the doing coming the the of and sometimes KOLs some but I potential is is whether the again it's treatments some stage, also thing, and treatments. websites of Palatin same or condition at and effort that's AMAG

John Newman

just in but [ph] look, we to plan obviously, members you really just of that's but we do or if familiar advantages that of regimen? FDA we safety panel in advantage, dosing plan that the we're an panel, dosing have know panel how really will of terms you on of this disorder? really advantage you for product terms it's be an on actually explaining think and terms the think the with good you know, injecting some suspect I you in emphasizing Just ADI perhaps on-demand how

Carl Spana

will I what and in front a and on doing AMAG, are working tremendous on they with -- them be they the support and center John, we're personal of AMAG are is doing. we've job think Palatin been presentations

way meeting. have one, the we're obviously they on present in. be keep and be also we the company key present we and planning AMAG clinical how the these -- will will will [ph] have we're have the them patients think to a performed meeting, know, this You that trial well what at from is, fits But it's is experience addition have will is Vyleesi how to happen FC we'll not meeting, things accepted invited the Vyleesi as overall that there data, FDA opinion typically the presenting both the we to an how Key personal HSDD -- view and speak Webel And leaders will product. I will of and safety

will will How that's they think the the covered the have, obviously how and of I be panel. questions much panel. So we'll the upto -- clearly we'll it and latitude to all will articulated and have FDA there that Chairman the get,

Operator

question Our comes from [indiscernible]. next

Unidentified Analyst

With on I you questions a on pipeline other compared. Vyleesi, the have questions few

have you on mice And recent guiding showed MCXr and that the data deck data for anywhere obese some activator? this program? and mice. you MCXr, shows an these it's a Do to have PL-XXXX; publication also on slide do knockout strategy you First

Carl Spana

lot in tremendous we we yes, that The -- our is of we MCXr compound data a actually have selective go a the updating agonist. data certainly deck, the be forward slide answer as showing that but have of in the is we'll amount

have look that's you at pretty that's doesn't X addition, do do X-receptor, obese that slide evidence have animals we know melanocortin through -- good in process. we drug so if certainly don't that the we melanocortin show In work, deck,

there, and we obese in well. have as itself, that's are phenotype can regulating other I also in presentation we we've in in lacto-leptin animals have addition, that food so -- and is data leptin data a hormone and wait, got think In intake mice we the those involved -- that rescue the

in for area -- particularly of been been doing preparation we we exciting publications, lot in inflammatory now the and right the published, work, of right a generate data, as a of now PL-XXXX programs will that has as have only quite the So but for number have not we number we more at well. in data continue are we've to a of all preparation and that done as we've our papers

like much Vyleesi very year which a -- all will publications come not but strategy, these well. presented very as only should with meetings So we programs to you publication has see so or do rigorous which the expect abstracts start over presentations and has out to the at next

Unidentified Analyst

might And specific be indications included genetic steam you're obesity and are XXXX; a at plans your follow-up for [indiscernible]? looks on upon pepper [ph]? disorders and It what rare like looking metabolic

Carl Spana

those in that melanocortin -- of very may are of intake know again, lead for Look, I are think so play oral food that early you me have and that there [ph], obviously well weight. I onset that good a focus injectable other pathway it's one we patient And the pathway stasis mutation we're treatment in that [ph] children, that where need lot if of in mainly first. is role it's to I that there think are help -- leptin us these products, with definable there high, for you going and to quite in do companies played the population, regulation I obesity are number format think very that place start, but indications think with forward key in the a and

be preliminary good the hopeful we're that [indiscernible] program, work, and into we've that next will is, compound the studies trials we've forward far done formal it's the us year. some the looks early for tox like For ready tox but for inadequate next step that clinical pass really best driving not for hurdle that seen and so the and

Unidentified Analyst

are didn't XXXX recent and still development? I those deck; in in see XXXX

Carl Spana

injectable go XXXX product; again, X-receptor, molecule with versus is which very made the selective, peptide orally would injectable. be a of small so agonist we be decision peptide have active the to an a would that melanocortin and

an that deal when I being probably be able an compound injection think is to product daily an having release. injectable that to in extended would need you think I about advantage with would think or have either oral obesity versus formulations general,

Those to is of done and the go why we've great forward. amount these because push on compound; work molecules sure I PL-XXXX they that with second missed an -- it why that's -- the but -- half XXXX I'm they a a it's don't not guys not just to product, moved XXXX -- injectable second So we did, but renamed but decided compound small was and is tremendous we it that's I'm are quite internally XXXX. PL-XXXX. from clear the they did what did. why

that's -- and otherwise the one compound. they are same So

Unidentified Analyst

to inflammatory in XA My you -- this should this last sat -- an speak trying the will… XXXX; Phase question one pipeline overview on just where being that bowel on and give that this of development? us didn't clarify on We

Carl Spana

We're do it. happy to

again, -- should as we much been haven't earlier these -- -- programs with not at/or think and we put we maybe haven't I them. as information as be clear us are

working formulation there formulation particular quite the a there disease compound. treatment looking is are timeframe, -- one made and study in particular to the So probably go two the is studies Ulcerative next the the has for oral X relatively released that will in efficacy in for then we step it's compound dosing that And really peptide inflammatory identified animals. Colitis. October/November forward would show really so that's in Ulcerative we -- into formulations, study Phase it's it's a oral said would to hitting PL-XXXX, but a that in, as prospects tissue. of with to are study larger compound be And as regulatory way for is the in would colon I sites And that the about in target Colitis. we're been that as need limited to patients is product been onboard, position and formulation [ph] that to working in so quick where have that excited the the be show post filings we where humans the bowel be XXXX The start

just the subcutaneous the in-length is -- studies the XXXX will window quite I've final we where formulation, For therapeutic looking expect be. ascending single there in there the the systemic where just to inhuman I -- for going and both the We we at of first on there. with numbers, were completed we regimen, safety know mentioned multiple as any call, doses, we were there exposure the to no waiting unblinding we be expect weren't but quite high really look dosing we're or don't delta PK so a no observations, in both, at signal a laboratory went of

we're giving next subcutaneous really the that for systemic of we'd as our such drug be was animal with predominantly we as RA things at have and -- So uveitis compound are in step data seeing that [ph] really another immune humans. translation indication the where into those looking looking oral we

we're and same humans. work, in we animal reduction we're When macrophages looking response. see we And regulatory do seeing the inflammatory to studies. suppress the the going we the IL-XX the switching the a very we cytokines see pronounced thing if pronounced are or from of of we can sulfate see that upregulation -- phenotypes switching and the seeing importantly, While in inflammatory to in some of immune T-cells animal in which cytokine, are pro-resolution like either

-- pretty the So XXXX. pretty studies; their and we importance are as in early in development we're get now, optimistic protocols started so can

next to really in we're range what do quarters. that's full over the of So trying the XXXX four

Operator

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

Carl Spana

I'd like Technology's and thank year conference Palatin end for call. participating everyone in XXXX to fourth quarter

present. think As clarify asked Steve I with thank analysts questions, to the I earlier I they illuminate helped and who and always,

quarter updating to So over a I'd for of the and Thanks. you and you forward with course thank you participating. day to on like our the we look meeting Have great all progress.

Operator

ladies you, This Thank concludes gentlemen. today's teleconference. and now

You may now disconnect.

Palatin (PTN) 13 Sep 182018 Q4 Earnings call transcript