PTN - Earnings call transcript Q4 2024 | Palatin Technologies, Inc.

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Operator

Greetings. Welcome to Palatin's Fourth Quarter and Fiscal Year-End 2024 Operating Results Conference Call. [Operator Instructions].

As a reminder, this conference call is being recorded.

Before we begin our remarks, I would like to remind you that statements made by Palatin are not historical facts and may be forward-looking statements. due on accurate may results in and materially those based prove may may the are of Exchange from be variety Commission. filings to that anticipated Securities company's statements most assumptions uncertainties with or that not differ risks recent These and the the discussed and to the actual Please prospects. Palatin's forward-looking statements consider such by risks and uncertainties carefully in evaluating these

Officer President of over would Please to the our and like Chief Carl Dr. I Executive Now ahead. call Spana, Palatin. go to host, turn

Carl Spana

Thank morning, give the XXXX Financial With Chief is Good over call financial President Spana, and you. today Palatin welcome and Palatin's turn update. Palatin. year-end call. CEO Officer to Steve, to and fiscal me of the Carl call Wills, the on Chief the I'm he'll Operating Dr. Steve now and Officer. I'll

Steve Wills

you, everyone. Good morning, Thank good afternoon, Carl.

I financial few Before results, corporate highlight. reviewing have items to a the other

product, disorder, to closed for injection sales XXXX. bremelanotide developed of net hypoactive million Palatin Terms Vyleesi, for included Pharmaceuticals $XX million Cosette an from to million. desire sexual million million on potential $XXX on to $XX based up our in Regarding up milestones plus ranging $XXX annual December Palatin HSDD. asset commercial upfront $XXX or to sale

use retains rights and Palatin indications. bremelanotide treatment male Importantly, to of and obesity for

Regarding financings.

registered ended XX, in inducement year and direct gross million XXXX, June $XX warrant fiscal proceeds During Palatin raised of total offerings.

XX, December total completion record contract up Quarter $XXX XXXX sexual sales and ended of the any for fourth XX, and Regarding million. consists dysfunction Palatin the results, to XXXX, sale and Pharmaceuticals, allowances female Year net rights gross not in June Pursuant to XXXX. the financial Vyleesi of product accruals June quarter Palatin's Fourth revenue. for did to Vyleesi, product for expenses, again, of Cosette of and ended Fiscal of revenue sales license

product gross million million, net for sales of year. ended year XX, product fourth to June the for for was $XX.X of to gross gross million fiscal fourth June were product net pharmacy and expenses net ended XX, receptor revenue XXXX, the and quarter million million XX, $XX.X decrease with was prior were comparable $X.X June $X.X $X.X product quarter $X.X the recognized million expenses. million. Vyleesi $XX.X million the distributors to $XX secondarily, selling 'XX, quarter June elimination to revenue For the compared mainly sales revenue to XXXX, $X.X spending $X.X ended XX, product were product year. million compared million lesser of were the prior the fiscal expenses Total gain of sales the for operating with XXXX, secondarily, Vyleesi. for due decrease This mainly related fiscal of sale operating related $X.X Vyleesi and the the of expenses million year melanocortin ended fiscal the Total The programs last elimination of on the our result on and for selling MCR to was year. compared

compared cash for XX, XXXX, used in expenses to flows, used loss made quarter ended operations XXXX, This purchase in increase capital of is was period in in operating $X.X XXXX, same XXXX. June to to for $X.X in revenue same $XX.X the to ended compared in loss respectively, period to periods operations same cash the and expenses. above net commitments. Palatin's operating operations were under year for inventory related capital due was compared million, and and net and a quarter in respectively, covered in was cash cash the year decrease used the fiscal cash cash This for million, XX, XX, $XX.X $X.X and in Palatin's June million operations net used net changes. Variances in the million net used net changes used the secondarily XXXX. working mainly $XX working a net operations payments in $X.X Palatin's result Regarding cash for $XX.X for of million operations net million of was decrease the the of increased June XXXX. million fiscal ended million in to and

Regarding and cash securities million the engaged position, We, same equivalents Palatin our XXXX, development of call XX, involved with cash programs $X XXXX, I'll June were as actively of million potential as million XX, cash Carl? business Palatin cash $XX turn of $X.X back And to of compared XX, March needs as and advancing. Thank with in $X other now for equivalents June marketable of collaborators, and Palatin's cash and XXXX. is million parties both multiple including to is sources over that operating efforts, consisting future entities the for funding potential you. cash with

Carl Spana

ocular that was significant unmet exciting therapeutics Fiscal in programs. sale of Thank of to Cosette, start effective Vyleesi confirm XXXX significant and review covered to year achievements Today, of with the for all will our safe, market can has targeting address patients' therapeutic an in move the each I on already result areas. system for some melanocortin of and lives you, the some programs. pipeline Steve. needs. can Since I'm Steve results our going Palatin improve of our differentiated that with growth and

for ocular broad their dry treatments product made dry truly completed of of Current have has successfully is time excellent PLXXXX knowledge, the efficacy tolerability, signs trial programs symptoms on dry results has achieved Phase symptoms in broad to that and profile, the this earlier disease following: endpoints year. of symptom potential the main the To have that physical problems over of including demonstrated the problems treatment as current such ocular and co-primary disease. showed to eye and the X for multiple have poor leading They efficacy treatments. MELODY-X ocular dry [indiscernible] The eye they relief. The announced PLXXXX dry take disease. eye included X progress in of limit in tolerability, the as X MELODY MELODY-X PLXXXX of to secondary eye compared pain the III With solves [indiscernible] that emerging significant trial and III and significance the dry lack that and significant treating demonstrated for results that summary, broad our Phase endpoints, for be X long discomfort. past multiple ocular the PLXXXX dryness treatment for We best effect symptoms differentiated eye weeks. the efficacy PLXXXX the first disease. In for a utility. of disease ocular treatment early PLXXXX the eye eye year. disease product clearly X a MELODY-X topically We have FDA-approved no shown results Palatin's FDA-approved signs trial, is symptom have had in administered

the application the has adverse eye XX fluorescein that treatment is discontinuing after physical eye X agreed patients will lack subjects endpoint as agreement positive no with FDA science the weeks we PLXXXX which meeting, centimes taste, point III approval signs ocular at also blurry [indiscernible] weeks [indiscernible] dry symptoms trial to to and X-week due recent that the to and next poor were efficacy a with with FDA required significant staining, tolerability, for which the eyes of For who of sign high a activities excellent remaining over with our as new be vision, the significance sustaining continue in drug treatment of the rapid treatment. event. of rates. In burning, a efficacy primary the disease on PLXXXX led at satisfaction effects of to sign in and PLXXXX discontinuation starting an approved the treatment the of achieved tolerability and have time is bad a [indiscernible] for improve they a shows for ocular study dry the such with corneal of inferior dry disease. this has amount for FDA plan the the Phase MELODY-X. PLXXXX file

in primary statistical on system a of we our have agreement plan. to analysis Specifically, FDA subjects and protocols, end our sign point number

to an calendar in the ready XXXX. year NDA of the studies all complete conducted clinical in and PLXXXX completed with Phase program anticipated to be first half calendar filing and XXXX are We III remaining year

our be and vision category market treatment completed indicate a is of fiscal we Our differentiated XXXX. $XX programs a the current in treatment a loss. The damage our demonstrated is affected ocular begin we models provides neuroprotection. the In substantial estimated in 'XX. be PLXXXX nerve and is of a preserve cause extensive of vision, also are progress to glaucoma PLXXXX damage over XXXX, treatments is progression broad to year, studies and and fiscal factor evaluation made neuro diseases. disease. that diseases retinopathies. beginning retina to treatment completed ability billion administered ready retinal XXXX. Retinopathies to lowers PLXXXX novel retina the in involved Last in but PLXXXX calendar significantly optic of pressure, retinal lead approximately global trials intraocular clinical year with by the the in various evaluation that for positively differentiating X topically also protection Direct IND-enabling the models. to other for comprehensive now not can PLXXXX an from the analysis of multiple ocular multiple are to protect Results direct that for only known of glaucoma. treat multiple glaucoma genomic PLXXXX to development preclinical pathways PLXXXX, is

in the growing injectable receptor formulation Drug to and enter now obesity starting studies is also on MCRX now obesity established progress calendar treatment into our for of melanocortin development in made to IND-enabling XXXX. I'll move substantial is ready intravitreal PLXXXX We rapidly. and program.

therapeutics treatments MCRX agonist therapeutics and to melanocortin-based are loss drugs treating obesity, and development believe in the weight weight of of multiple manocord agonist a and part X loss treatment regulating are weight important of future to receptor needed. and energy studies the published of less of the for weight extensive well of for for receptor obesity leader the maintenance. With as plays in and action melanocortin MCRX mechanisms previously the will clinical have loss maintenance. weight we be effort activate a food be our including management. maintenance affect strongly weight obesity intake, Palatin loss we in MCRX an and develop with experience positioned We long-standing that research completed importantly, stored design development role loss Because and selectively that has of important different

all the and [ such are creatine-based I'm ] demonstrated impressive in as growth. Zepbound and know, obesity, As therapeutics, Wegovy, primary for have treatment sure you they

began due they lost. have to patients often to in discontinue side up first quickly and of and weight effect that a effects the that treatment they XX% plateau year, the However, mainly regained

on initiated combining the reducing enroll gustosepatide then including which before of drug, treated approximately is August. obesity in with of the coadministration eligibility study quarter profile groups academic undergo clinical Agonist indicate tirzepatide agonist or of help XX receptor weight small of weight an MCXR these The Peptide study are subjects this well U.S. The GLP-X their be combining In weekly a effects treating receptor of agonist and Receptor the will loss reach receptor tuseplatide will X assessments safety of approaches also in provide study of developed data X bremelanotide GLP-X at opportunity with weight Melanocortin-X will daily needed as these on or of the and tirzepatide MCRX better efficacy additive the agonist agonist, and tolerably weekly consist with randomized efficacy in a next-generation as to treatment loss lower in safety Patients tolerated to sites weeks receptor first highly X Patients dusepatide loss in that be quarter study and alone. the MCRX confirmed the like with for treatment conjunction endpoint and subjects treatment primary and maintenance. increased increased is Phase co-administer II body effects arms, loss, Additional bremelanotide. general weekly will multiple daily having and over at agonist with safely tirzepatide. and for may by GLP-X bremelanotide selective of weight weight goals. Research of therapy. stand-alone sustained demonstrate investigate receptor with the calendar effectiveness molecules to to and with obesity completely a the along To This the result enrolled doses. we as to potential patients synergistic bremelanotide to allowing study in to Palatin XXXX. We've designed

effect. with to week lease quarter Our have and to highly in proprietary They're new peptide once MCRX a calendar designed in of studies XXXX We MCRX anticipated first are XXXX. second selective the calendar the the first-in-human final the skin receptor receptor as agonist using for side of technology clinical IND dosing. half and not darkening MCRX are have versus a receptor an anticipate selection a

move sexual and we'll [indiscernible] to Now dysfunction. on

the We in to the to treat male product led a are of bremelanotide has research co-formulation a Our use agonist those novel dysfunctions compounds various that is and XX% limited a melanocortin therapy. development sexual female as an inhibitor, of options a phosphodiesterase such of and of treatment and PDE-X could market. this that large the be inadequate These believe product Cialis. erectile to have an have Viagra patients men ideal represent and underserved response with for inhibitor dysfunction

it patients and therapy.[indiscernible] coformulated study study to with colitis that XXXX, which model in analysis expect colitis inhibitor and provides we completed this a evaluating is agonist PLXXXX in nearly causes half a program Resolving of that PLXXXX, of in second II and from interim to to a bowel calendar receptor calendar later in the with Phase oral The a initiated results the want also In is a program, to oral the different is PDE-X efficacy, the treating study initiate to inhibitor demonstrated in XXXX, of I blocking to in rather clinical significantly program inflammatory PLXXXX safety diseases. development PLXXXX in nonresponsive is the II of cover study top also XXXX. The are line healthy colons studies selective first preclinical rectal treatment final possibility inflammation patient with have than with We and and Melanocortin-X is clinical colitis, anticipated oral support Phase our half with dysfunction recruitment and quarter. improve treatment the inflammation. the resolve disease state for of the our expected of enrollment, coupled data PDE-X toward evaluation for patients. bremelanotide

in continue to the complete importantly, for forward, programs successes disease and the of look programs of continued we ocular to and eye the past dry and obesity we development focusing program in evaluating we retinopathies and milestones have collaborations Upcoming the and bremelanotide programs [ As eye year or by Phase dry other the MCR-X and want build want and reported coadministration our II first for disease, calendar glaucoma key of on quarter partnerships XXXX. ] on our [indiscernible] novel colitis data program. activities of obesity in for the include study and following: definition our the the program. to We intesepatide, out to expect

to on through year dose-ranging the during and XXXX. long-acting are also for We program our selective Phase track MCRX in calendar advance efficacy II immune first studies peptide a agonist

we with application drug program corporate want by new facilitate MELODY-X forward, with collaborators FDA start in For XXXX. activities and to To trials are our a dry half XXXX. file eye manufacturing this to expected calendar Phase also disease and moving complete want the discussions of and MELODY-X partners. program, the potential III with funding beta the calender we year-end complete in we needed all And to first active

male of want we and completed recruitment year our half start first started a begin XXXX and in in get the our II/III dysfunction anticipated which of the For study, is calendar second Phase to half sexual to program, [indiscernible] patient XXXX. in calendar

these patient of [indiscernible] address licenses as to and and our potential now medical improve team over Steve as needs. Palatin increased I'll to the excited call lives our the innovative support and earlier and the well pipeline our by significant bring novel questions. programs enthusiastic to programs. of turn are unmet treatments business major also development to extremely the we've whole activities Importantly, programs I

Operator

Instructions]. [Operator

question from first H.C. is Joe with Pantginis Wainwright. Your coming

Joseph Pantginis

of sets X questions. So

program what to lean your stage, issues? wanted are loss to of study, impact you about weight weight the share mitigate on on of minimum the for talk First, well as I pigmentation next looking or looking eliminate us a hopefully, you GLP-X. some loss what benchmarks mass that muscle to with or to of alleviate could to as you do or to the move success are see limit with

Carl Spana

number things, Joe. That's Sure. of All a right.

talk is and equal using was X trial that So about conjunction equals let the me in tirzepatide. can bremelanotide main II Phase [indiscernible] there be additive an X et which expectations for X current we're there and X, X, effect where are the The what and cetera. X

a So a what tirzepatide the primary measurable separation. analysis no be will the versus comparison And is for co-administered significant there's essentially of -- alone. looking we're set or

long-term treatment. are these not on patients Now

So not their are be over X losses going XX%, to weight XX% weeks.

to the in we to on able X% range. should want X% be which on we X% to And additive going be to an see and what to going think effect to You're see, range, based we're X% expect we that achieve. design we based

long-term So again, where very we're should study numbers, -- from it's using you're going that are synergistic. not clear signal not a to a X we exclusive additive not again, it's -- or these expect study the see but really

Joseph Pantginis

Got it. And it. the pigmentation. Got

Carl Spana

the in so first approved, of are there agonist, generation one driven activity darkening -- And X that So -- with of the is MCR-X by against in skin to them not actually several being [indiscernible] bremelanotide receptor. were the there can darkening. when it's chronic like they be issue, the we don't use, move issue an that for obese an on patients, short-term patients case use more it but skin of

been So that. been to And devoid really of I've able working compounds activity. this we've you in number in MCRX order that, need do of achieve to on extensive the based field are next-generation that years

And substantial between the nonactive them MCRX. evaluation X not at compounds are fact, of So final that we receptors. many in are separation in have

those then is about much it's have are MCRX with So monoactivity small think molecules, skin MCR any and front. we when at the selective highly smaller those And all. doesn't don't [indiscernible]. on pharmacaflora really we And any peptide the compounds. expect darkening

Joseph Pantginis

helpful. great. to No, just that's dry the switch it's program I I think eye Yes. to wanted because

forward the study You the of great these programs. discussions FDA looking from the already have and to visibility and

I just So from wanted different? And Are look end? primary to to your how discussions logistical guidance are guess, I mature the MELODY-X? signs make do FDA, from would endpoints but the these from they in standpoint, think how assessing you more the a sure, same and on symptoms in business or development, are the the they

Carl Spana

Sure.

backwards. kind we'll of work So

time green the we're So the X-week one used corneal that meaning better And in symptom in staining a sign significance used that is stains the it's just rate sourcing these point into because is inferior at The of fluorescein listening accepted the all same it's was sign MELODY-X. exact and in sign floristaining, inferior generally that there's is from that corneal dry moving MELODY-X. studies. to

you, with concurrence to So and done. hired we on ready we're of both those assuming have to going the protocols being FDA the pending study. With that. finances are what appropriate CROs of with have And the together, SAP in the and regards again, together. use the go, --

the will be the ongoing with middle towards So results lot a some we're we're moving transaction. in go good pretty in your have we those where are very standpoint. of towards licensing I from as a of And pending had those, that question, funding. deal waiting a -- we And we now a of them. that appropriate secure corporate conclusion of really of was kind to into would of and the reengage And soon was of which moving wherein discussions were I mean entities, [indiscernible] sort we've as part There first for and your forward those much leads we meeting ready on say what with or that? entities the interest discussions hopefully

interested discussions we've some more would forward Phase funding good that larger the be with as it III potentially moving that, to addition also in uptake very funds and in program In well. had recently

really attacking new we've been fronts. I progress we're discussions. it a [indiscernible] So actually taken with we've making. the pretty those I've X leaves been think Steve's because on And obviously, little pleased Steve But

Joseph Pantginis

the Carl. to about Well, and it's hear good the thanks for optionality details,

Operator

from is coming John with question Newman next Genuity. Canaccord Your

John Newman

tirzepatide. has of some but because co-formulate know for do been The the with molecules. question potentially which that Carl the eventually, at fantastic your one be reductions. products, there's a potential I'm address some to obviously with will loss to combine with those weight you we here is treatment, revolution is been least do But MCRX to selected novel the see price of asking that way Question agonist Carl. for reason in drugs is, the GLP-Xs GLP-Xs, like

but your longer And just long for curious potential so term, term, immediately if over that's a maybe the I'm compounds? maybe avenue not

Carl Spana

Sure.

done So haven't lines, yet work. along those any that we of

pretty highly are the it's GLP-Xs working think pretty soluble and these feasible. formulations I compounds for The that these compounds, we're are both However, with. stuff

it it's to those So lines, in which formulations up come should easy with be combined. relatively along or

could together. should lab to guy but the work, say that do relatively to get think theoretical from Now I I the actually it easy the standpoint, a not be being who X that does

Operator

There in Carl questions over like any now floor no back Dr. queue I the additional remarks. turn to would are to Spana closing at this time. for

Carl Spana

all to tremendous like Well, for very to Palatin is team the a our have on great call. would updated have next press well. amount you. XXXX our and presentations a Steve thank year. looking whole we you releases analysts for excited you quarterly forward forward Thank for of on investor scientific the a listening what meetings. That really small, to updated. we're like keeping year-end being calls to [indiscernible] a I'd and over and opportunity, here. keeping this day, as said, of can fiscal questions to we We're we the -- their various mean look all I and and hope at and thank deliver Palatin and and I you progress you

Operator

conference does This you, Thank conclude call. everyone. today's

disconnect phone day. a may for lines wonderful your this and you Thank time, at your have participation. You

Palatin (PTN) 1 Oct 242024 Q4 Earnings call transcript