PTN - Earnings call transcript Q2 2022 | Palatin Technologies, Inc.

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Operator

Hello, ladies and gentlemen. Welcome to Palatin's Second Quarter Fiscal Year 2022 Operating Results Conference Call.

As a reminder, this conference is being recorded.

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

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

Carl Spana

Operating Executive the Officer the Thank Quarter Steve? Technologies Steve call Officer. Carl CEO today Fiscal welcome Palatin. and of Palatin's Dr. Second and I'm is Palatin President you. Vice Call. With and Financial Good Spana, morning, Chief President, to Chief XXXX me Wills, on

Stephen Wills

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

Palatin's fiscal results revenue. of accruals revenue gross Regarding second XX and quarter XXXX, contract sales are consists ended financial product Vyleesi, December allowances licensing Total net of as follows. and of

$XXX,XXX amounted sexual for to our of product product product of sales Vyleesi gross approximately, product the $XX,XXX revenue for approximately reminder, approximately sales net to with product is a compared to pharmacy in As revenue XXXX. gross quarter comparable net quarter of XXXX commercial disorder. $XXX,XXX XX desire with ended distributors December Vyleesi approximately of with negative for the hypoactive the treatment $XXX,XXX premenopausal women

comparable flat result were over the dispensed distributors pharmacy recognized of pursuant comparable product quarter minimizing XXXX Vyleesi, increased its revenues agreement product primarily ended were sales in license to This XXXX. Fosun to in Total revenue quarter net revenue license recognized contract no net XXXX their XX the period revenue XXX% was quarter Pharma. licensed XXXX. the XX significantly gross sales Regarding XXXX XX% September prescriptions and The XX insurance and in per over XX% Also XXXX. decreased inventory over and in ended ended importantly ended the XX prior decreased gross XXXX. quarter net XXXX. product September during XX comparable There for and increased December prior with quarter for December quarter the reimbursement product prior the and the $XXX,XXX XX% ended and the prescription in decrease revenue dispensed quarter end-of-year quarter levels. the decreased Palatin same September Commercial compared XXXX,

Moving expenses of disease. expenses to for for related ended advancement quarter trial decreased decrease $X.X PLXXXX million offset operating the were Total quarter commercial in pivotal was expenses to operating over Vyleesi a for XXXX in increased primarily XX compared $X.X XXXX. December the dry comparable from the million development expenses and by suffering to research into related X to eye operating result expenses. Phase of clinical The the patients

December quarter $X Palatin approximately ended but of that million Vyleesi by of inventory of negotiated used one-time the in was in our Regarding This Palatin. compared a of to payments XX assumed cash used decrease part Pharmaceuticals $XX.X agreement AMAG with net was XXXX. related Palatin's flows, for million mainly due cash operations the same period million XXXX $XX.X December ended in net quarter The termination XXXX. cash of commitments million also included to to it is AMAG operations the to $X.X in purchase as for XX payment

same diluted loss $XX common diluted loss period net December share net $X.X $X.XX ended and compared per a for Regarding XXXX. share Palatin's net million common basic or for or loss, in XXXX the of $X.XX and XX basic per approximately to was quarter million, the

and currently be XXXX. receivable that March expenses plan, million equivalents of cash December $XXX,XXX cash accounts as $XX.X sufficient XX XXXX, XX were cash will XXXX. September position believes of fund operating to least through cash approximately and compared of to million cash $XXX,XXX equivalents Based and Palatin's on Palatin cash operating XX as with our cash accounts anticipated of and current receivable Regarding of $XX.X at existing equivalents

to going the over I'm Carl. back turn to call Now

Carl Spana

Thank you, Steve.

Turning we support how a that Vyleesi money the objective Vyleesi, value prescription. meaning on commercial operating to to of metrics been make core has the optimize our

For prior quarters. the insurance quarter, prescription and rates over commercial increased coverage, per prescription all refill net revenue

is option ultimate committed our partner of sexual Vyleesi objective a a continued to return disorder women Vyleesi the relicense premenopausal as a for ensuring availability and desire to Our investment. hypoactive on treatment

We the continue on of terms territories and U.S. right partners to is the several partner. with and dependent engage potential in with reaching timing license and us other the potential

medical diseases there safe across with on, for and inflammatory Moving provide multitude effective of vital need treatments new remains a autoimmune clinicians and and a patients options.

system, restoring a research primary pathological as blocking melanocortin a developing modulate superior can for ophthalmic suppression the for drugs focus autoimmune more targeting new and the to the of state and normal treatments body's are system concerns. one By healing. one and believe melanocortin diseases differentiated safety for that can current the by development pro-inflammatory eye major on suffering We and pathways, diabetic modality with diseases dry uveitis. promoting on retinopathy, safety develop profile. focused treatment which the inflammation, work therapeutics patients from Many Our that natural mechanisms cause immune immune tissue and a operations with efficacy we inflammatory of inflammation, resolving system, or such highly

establish of to system level therapeutics. based a molecular the clinical have multi plan and melanocortin advance We at layered melanocortin to the validation, understanding our a

designed of drug non-ocular Our treatment as diseases. clinical new and of system class therapeutics utility to autoimmune include the successful, indications inflammatory developed a are A melanocortin have development development. will broad the we of target demonstrate ocular, for new a programs for

the of the diseases Our first PLXXXX most eye. affect the front for our happily advanced ocular segment product delivered of is or interior melanocortin agonists tissues treating that

data preliminary XXXX. is Palatin in and in will X with has scheduled the for XXXX initiate of U.S. May interim patients This sites assessment week to disease second second of data the half eye Phase the study the XX period. and on moderate efficacy a will in is control successful, an patients the includes versus data an and for safety disease called study will melody pivotal file study required enroll with a these enrollment a The severe X provide is to is eye dry PLXXXX and in upcoming the into over dry by safety drives X ocular studies application drive will study The to vehicle X confirmed increase of an emerging called safety that dollar three interim to dry endpoints a X The efficacy on tolerability be that the Melody patients an treatment disease dry advance called XXXX, of in Phase open label eye PLXXXX will comprised Phase needed, detailed data new first X. we determine Melody disease. secondary assessment PL-XXXX FDA. disease substantial key PLXXXX monitoring with the therapeutic December X. Phase the in Three penetration and the are we study. Melody reducing target Melody three and eye study of disease indication committee dry data. profile PLXXXX rapid X clinical safety began evaluating potential of the us potentially XXX allow with at risk analysis number data multi-billion conducted its Phase enrolling results believe independent therapy. the is profile a currently for the underpowered the hypnosis, multiple drug in if dry distinct scientists onset, eye subjects of is X that The If More based excellent XXXX market. X Melody be co-primary

in utility will investigational multiple are other to eye as to and new a eye drug PLXXXX an melanocortin the well. of XXXX second disease the front With indications disease treating have planning and the advance filing in of part indication we

development As we move of to PLXXXX of treating agonist types the in eye. the a on retinopathies. for melanocortin back various is

innovative are with presented the which XX protective models designation. presentation XXXX data Meeting conducting immense of of various PLXXXX. Retinal of file was We recently a begin drug retinopathy retinopathy the development We for Specialists, -- pre-clinical the describing The IND will the at an current the awarded activities pre-clinical FDA, us top the Society market of activities allow to of the its American to clinical currently for believe billion current effects extremely XXXX the Annual the PLXXXX market diseases body. in excess poster by and to with of be a to was for significant XXXX. end garner impact XX new is $XX and There we the PLXXXX drugs billion for a approximately of treatments of remains positively retinal and large other patients in large need development in projected retinal potential market. this Obviously, a parts has on tremendous early the part disease little move and eye

innovative a multi-billion safety and various enrollment, are as schedule of be efforts well as as formulation on for Colitis, a patient study diseases initiate proof-of-concept there in well. a treat treatment a receptor a the of anticipate X expand diseases. inflammatory safe system designed to business profile second agonist dollar bowel to of inflammatory remains in study inflammatory a drugs to Our and drugs oral our advanced This Market the of evaluate and evaluate XXXX, licensing the of potential target PLXXXX. our will in quarter and in pediatric need PLXXXX as validation advance population. first safety if oral will second particularly results Phase readout and PLXXXX is development study of or bowel a initial clinical of half the effective important data the to the and emerging efficacy XXXX. treatment patients. positive melanocortin around these X for we appeal potential a large melanocortin for The We the the selected FC be new, options for the XXXX add would of the will treatment disease, and treatment This confirmed, oral for that bowel major Ulcerative as the study

additional programs You our on website www.palatin.com. our on could find information

a melanocortin Palatin advance an data clinical for major two on readouts diseases exciting towards advancing studies. company year programs and This we programs well-positioned with modulate drugs additional a system. treating for are autoimmune As that based two the on mechanism clinical and to year new inflammatory is

players dry we before for on summary, on begin year called before enrolling in quarter be X the with go dollar the Oral by year X, in May patients end in proof-of-concept end second significant study analysis is the Both study these of Phase have a data actively innovative interim Q&A, with disease also growing Ulcerative patient markets. PLXXXX Melody X at XXXX data for to preliminary Colitis treating XXXX. a pivotal potential So enrollment multi-billion the And into to clinical in schedule XXXX. remains of drugs schedule XXXX. Phase PLXXXX

with innovative new that an grow of investigational as novel PLXXXX treatments at an reimbursement scientists at studies, partner. drug per prescription, insurance collaborators significant eye towards business clinical and development agonist, towards our least to improvement a in programs of IND refills. revenue well to of show in been pipeline treating continue clinical a the engaged development major of actively of activities and actively also of are research. treatment sort filing to Palatin presenting support activities Our relicense, as agonist commercial meetings, Vyleesi front in the prescription for melanocortin melanocortin in continues second we core advancing and have medical advancing our filing metrics also We're retinopathy XXXX. and committed publishing The

ocular Our a Palatin as exciting are company diseases. efforts establishing communication for developing new treatments

open look impact We to XXXX, will and will shareholder call patients tremendous drugs support. are that of for value. you highly positively be forward As a the I call and opportunity our we your advance to The to to build differentiated now questions. continued we listening excited Steve innovative thank portfolio and for have like by that

Operator

our Thank Joe from Please [Operator H.C. take ahead. question Wainwright. go We'll with Pantginis you. Instructions]. first

Joe Pantginis

morning. Thanks couple A question. if mind. don't good the guys, for taking Hey you

little can with flow a kind just maybe regard the the DED specifics will the be on planned first, or pivotal as what it study of be upsized? more the study, be street? to and Is anything news interim expected continue around by So

Carl Spana

data a It's not an assessment, analysis.

some a making looking really look, our variability. the the particularly to things calculations power innovation key So add just under or be give important that at of of drive important key sure not does endpoints endpoints, those don't studies upsize underpin they that these it's of these us really whether want allow or we and type this on we we be power secondary stay as secondary they're And regards is. us really to And to degree label. the to have to going get an approach study need make in will to the for in because study, to guidance we

Joe Pantginis

you other second. to might in and with eye XXXX Got type types it, that's indications helpful. of And just but know a I as deep in, interested very now with that setting indicators stick well be be beyond? willing of broad I additional right the go too let's this of for you front ocular even guess as might is a necessarily question, not stroke ocular

Carl Spana

needs compounds better the are help function, is eye diseases that in are haven't better a I yet Sure, market you. I front think things for we XXXX indications promote eye. we're important would are really that surgeries types of are various other where can for treatment to and healing, surgery have XXXX the eye lot of desperately big need the interested really the back new other things what of corneal healing so example, and there treatments. around related need like that but of for cataract glaucoma, types done that there that and tissue very be And the mean, agonists that outside only many disclosed, of example, dry ones of

there few out we're of think can use to indications that indications. the data disclose are not eye yet front addition really represent we just to pan that, a that to preclinical In new ready what

So very think looking we're next we'll year, there. deeply. lot really of flow have information And over a the I

Joe Pantginis

discussions, even increasing No, can here expand or history switch and obviously the are and question tenor how to other yourself on your out seeing or the just Thanks. the considering more glad to see Health can it's I'll overarching now, gears, whether I take the to engagement has I could discuss those with the just so for long that's discuss, outcome options even describe And say payers, company if the Vyleesi guess shots I potentially to that you spin Women's last want with question, right of your fair. my you commercial level ongoing you some don't again? know, that depending wild keeping is, Vyleesi specifically of you're but for discussions company, reimbursement a

Stephen Wills

Joe, one. I'll Steve. it's that Hey, take

point, mentioned better than So let's in do. Carl to objective that as and relicense But to order. a mentioned, not particular fits we've the our Vyleesi on that company just is last a prior, we frankly

started healthcare can strategic that. do the they where to that they it digit infrastructure, had into got use hands, had to someone we justice, needed the Our negative strategy net some treatments, to the Colitis net revenue, the to certain actually hands which that term have going have the I'm reimbursement, is concentrate. we I targeted the but net. in know disease going the the the some the going anti-inflammatory, don't Ulcerative vision shows ocular trials, forward that believe back, is down will the when product want additional brand. we se, I mean negative resources, right we've point, And single metrics done autoimmune and gross we we so start we focus, eye female insurance I we per their not absolutely but expand landscape, get illuminate and We to ocular the where to if frankly, at dry on. don't

insurance, insurance gross XX% importantly, greater get is have when dispense So of covered prescription to going you coverage. your significantly. we by to insurance every coverage, good increase very And we than we net type that now, of is have

putting where that's in social be but We we we've concentrated we're So to do ground. going efforts. our the not are on engaging still feet media have that

that's we're But not looking place the XX, We to now. have to XX, part. right for folks sales new going in expand XX, XX several sales, be to

done very objective insurance something on just very, have, lot prescriptions on it's wherewithal even ground whether somewhat the is extrapolate specifically more then easy reimbursement to someone in good forward, if do tenor do will can on we've because good, And showing dispense, they a layer it's hands, the the the B gross happen is and they better the positive, their hands in with going net which well. can the we to so that for the feet to a we or the increase specifically gross the right and very, being than do product We their access. the tenor, with So is think insurance increase net. infrastructure job it's this reimbursement, market with we're think that the then A, and that strategy

whether So doing of point, the be our continue to the in we're much a it, possibly of take Lifecycle or progress other for to with There's HSDD expectation paradigms, your out for metrics. hand, in the exciting there. that home postmenopausal areas Joe, good male is right too to right license to the hard and primary that path actually in the at is not we're On with could the approved is quite women some in But calendar be there. objective clear, treatment And it's response showing 'XX. looking treat that premenopausal the the Management for targeted hand. sometime our find will other this in the opportunities even that man other we Vyleesi

that was responsive, hopefully Joe? So

Joe Pantginis

it. Thanks guys. It a certainly Appreciate was. lot,

Operator

take next Please Ladenburg go Michael ahead. Higgins our question We'll from Thalmann. with

Michael Higgins

Thanks operator, the opportunity questions to ask I here. good some morning guys. appreciate

KOL looking forward one since a different from March how events? but before your previous off, be event First you X that tell would to sparks them Thanks. question, this

Carl Spana

I Actually, just out sure. today. think Mike Sure, that one

find Opinion but on that. dry how actually out shortly a eye to Key information March we coming website are what did we disease to Leader and the So having on mentioned, listen on event you'll X,

as be Our new going of the think PLXXXX, talk there sees PLXXXX, is down to what's cover going going are space. the those, development. and how impacting he's also is we're really part and eye manage the first to We're Dr. for going to they're And using. [indiscernible] this the about approvals and besides he want pike things he's how we these been in commercials are that disease go coming other point, review really treatment, that are just also designed in viewpoint dry options several not we is current to patients, that there's

So as we'll be covering some well. those of

course, profile, of treatment as respected cover Michael well ophthalmologist, also the how fits will trial. well a covering potential field we'll Raizman, well Phase X the XXXX as Officer Chief Medical also We Dr. as and into disease who's our be that

would learn really learn want you'll disease, So it want to you if to to listen you be about eye dry lot. it, a something

Michael Higgins

for very helpful. That's that. XXXX. staying Thanks Appreciate with

this as it? you of data, we're your Thanks. your year? in does impact forward on going So are thoughts on What the potentially noted thoughts partnering back half looking data that? How

Carl Spana

to Sure. a it, Listen have We're our we'll strong engage of opportunities continue we're that -- you are various to this forward. want we where programs. positive based -- our talking have to some expect And tremendous we partner various have programs. what on make a the interest. whether The not all about of going clearly obviously to to clearly, it's tell if I go a not around routine in activities and have never effort. data actually development I've want business data, strong business of development Steve, or decisions at potential we basis to stage partners would amount to

Our the based strategy, to goal that we're to. maximize on that's and right if the going data is the value

Michael Higgins

Thanks. with in for of are but that to interim your there be Make trial terms sense. also design. XXXX well there XXXX. [Indiscernible] switching as as well? Will What partnering. And thoughts an

Carl Spana

One, really we as or forward was see potential to And when has there cons that and to pass oral is our This Yes, formulation UC inflammatory said of for not time do goal two bowel XXXX, program. think -- that this patients. whether things. one great we've is but potential don't various actually going really ourselves anything study a any treatment the license so it's from multiple designed it partners. is point We designed, times any of else. input actually is disease, UC it's in that

a I when a So hasn't out very around oral it don't as PLXXXX. there GI has there's meeting taken been we helpful franchise that think

analysis interim, an data or demonstrate of part, look have an is there need built is that a According amount to an have that's there what a will at analysis, that interim have trial. end that's built just and interim the the as study what the gotten in we tremendous patients are XX in. things we will the We it, year. identity will those last we is of have have to first is interim what by the in there feedback the And would been

Michael Higgins

have looking that third, of be Perfect. of milestone a financial any maybe And money question Thanks. ones How from kind at a end? in forward that I others And you a Palatin, couple half here Steve. many related then year? this what guess the back Thanks. they for warrants earned? of did milestone would came related year did milestone the

Steve Wills

Michael. Thanks,

Let me end year. of the take the at easy one money warrants in the Zero. the

warrants have which of we no XX%, is very Because outstanding thing that. and table. why? a cap million clean know You outstanding, XX% common $XXX good

that are grants equity We also warrant. again, add the for on But of $XXX million no options, outstanding top about total diluted. fully employees, for

money. the knowing obviously, So

Regarding that the for contract clinical focus on that it -- a advance don't revenue program I from was for the them the material payment trial for regulatory trial the XXX,XXX. standpoint. to for a I milestone was call think

the be So each, for whether is on, planned going on or it's on to milestones for regulatory. -- either focus next

activity the on they're any filing not advancing to milestones, clinical get as going the to approval. and for be we're regulatory types of going the any So regulatory It's filing.

So don't coming be -- them. expect That don't anticipate else in would 'XX event. from anything we XXXX a

Michael Higgins

color. Thanks, Awesome. again. guys. Appreciate Congrats the

Steve Wills

Mike. Thanks

Carl Spana

Thanks Mike.

Operator

Newman question go John from Canaccord. next with We'll our Please ahead. take

John Newman

Hi guys, the question. for taking thanks

Just analysis wondered interim study. this there like It we'll later sounds PLXXXX for the year. see some

Just stage curious, at be at just the are looking of that you'll this what development there? endpoints

Carl Spana

The evidence healing on colonoscopy. we're primary endpoint for is of mucosal based looking

score Mayo the looking score, for. one is primary So that biopsy be we're using we'll a the Mayo

being also for endpoints symptom relief. patients looking weeks. treated But eight Of are is these at course, have secondary we this

This which is collected data There's -- into also proof-of-concept is this a whole lot to of of of typical healing, being which generally expect strong endpoints. eventually a is study. evidence for see pretty translates pretty translates here, secondary symptoms into should a being we variety is So relieved. mucosal patient

John Newman

extend question take at will there? the primarily might one have desired potentially just simply then Melody for look Or to add will or to Thanks. look study. PLXXXX of you And that interim, focused be you When number the Great. on additional that follow-up either the period, if opportunity, on the you a treatment patients you study? the

Carl Spana

just it's of patients a So number added.

need the study these may are past typical periods. So that drive to of need Melody studies treatment feel a to second extending in that, particular be be not we that they We're move X if they in to straightforward XX matching? this question, to bit study, that the up choose are week the we will They'll at certainly extension, give that a And up. data numbers just the so, looking really will then standard on open to course being over are we safety and power calculations. have and in treatment. we us if Melody But the X, which collecting deviations a label moved are moved they of seen, pretty hold And the up. based be of as are data full-year as is little guidance how it's do we'll

John Newman

Great, you. thank

Operator

and this Dr. Spana today's gentlemen, conference or turn back I'd ladies any additional session. closing concludes for this And At to time, the question-and-answer remarks. like

Carl Spana

here. the things quarter to call. everyone conference like in fiscal of Technologies on stuff going I'd happening. Paladin participation lot thank Good for XXXX A second

of moving and forward nicely. progressing are All programs our

participation look to progress well. I of thank and and we our on all to So your you for I and Certainly a throughout you thank update -- Steve their patients And forward employees like our year. look collaborators Thank want to we'd as and continuing to have the day. all great participating.

Operator

your concludes We appreciate this gentlemen, conference. today's and Ladies participation.

now may You disconnect.

Palatin (PTN) 15 Feb 222022 Q2 Earnings call transcript