PTN - Earnings call transcript Q4 2022 | Palatin Technologies, Inc.

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Operator

Hello, ladies and gentlemen, and welcome to Palatin's Fourth Quarter and Fiscal Year-End 2022 Operating Results Conference Call.

As a reminder, this conference call is being recorded.

Before we begin our remarks, I would 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. That the actual results may differ materially from those anticipated due to the variety of risks and uncertainties discussed in the company's recent filings with the Securities and Exchange Commission. and prospects. in risks statements these such Palatin's about consider uncertainties evaluating carefully forward-looking Please

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

Carl Spana

the me over morning, year-end and today on I'm Carl the to call. President and fourth Spana, quarter call Thank you. CEO welcome of Palatin Steve? Good President, Dr. and Vice fiscal XXXX I'll Wills, Financial Palatin. Steve, and is With Chief will Executive Officer. the brief call Steve Operating and turn the give Officer Chief to he and a Palatin's financials operating update.

Stephen T. Wills

and Thank you, the an is a to marketplace to that the two product, U.S. some quarters commercial FDA-approved objective are we program Vyleesi, hands. committed Carl, women's value scalability for value demonstrate hypoactive the commercial Vyleesi with of program showing product disorder. believe with and in company. of And morning, in Starting the sexual the last Vyleesi goal the rights our absolutely right everyone. of highlights. the is desire relicensing good The healthcare brand

XX% XX% compared comparable XXXX, per Patients over reimbursement comparable increased Total increased insurance over ended prior for increased in prescription quarter prior quarter prior the the fiscal XXX% sales in the 'XX, before other and gross quarter increased in XX% to with dispensed over learn securities more XX, account prior offering non-financial being XX% at million. HSDD stock, Net for comparable somewhat entered This the stock. and Specifically, shares on offering investors. all comparable and items, escrow few gross a increased the was prescriptions and and increased vyleesi.com Total in product to deducting into the XX, June deposited XXX% over quarter the and the dispensed, institutional healthcare quarter on XXXX. the purchase or revenue Vyleesi fourth redeemable or cash May rates, expenses XXXX. regarding agreement vyleesipro.com. Palatin increased XXXX. over redeem preferred the revenue the a Touching shares base $XX convertible product convert XXXX. pending providers election quarter over money and and can quarter net about proceeds from an is and commercial to quarter common in, Refill quarter investors' in notes was held the

gross to product product the the net XX, XXXX. quarter revenue XXXX $XX,XXX and product to license common increased revenue. of the accruals Gross $XXX,XXX year and specific a $X.X revenue to product and authorized June market $X.X American stock license $X.X to quarter of year year products stockholders ended at net approximately the trade product stock. June annual and increased little common Regarding the comparable $X.X with net June year a XX, negative approved over the our product sales XXX% fourth ended amendment to and million and the sales symbol allowances 'XX held amended XXXX. ended of which recognized of fiscal ended split products for recent the and effect revenue $XXX,XXX for restated the remains Palatin's of XXX million The sales increased stockholders Certificate license overwhelmingly stock The sales of for of reverse the XX, fiscal yes, were pharmacy product total stock our The our common Board meeting the the XXXX, Fosun net PTN. in contract quarter pm Kwangdong. of for company's Palatin's $X.X June of reverse approximately and split, negative, of change gross into sales $XXX,XXX to the with of but company's company's This stock on for million related year revenue XX, the the increased stock XXXX. a million. effective sales a of XX, under to at gross Directors of June the for XX% as number $XX,XXX of distributors net XX gross with and stock, million XXX% on for over June X XXXX, net revenue compared ended reverse for compared sales August ended fiscal net some shares approximately split fiscal continues XX, number were of compared agreement to the X/XX/XXXX. Vyleesi gross June million comparable Vyleesi NYSE, with Time of not over XXXX. Vyleesi, XX, XX, revenue, ended shares to XXX million product the implementation highlights, XXXX, the revenue revenue distributors a quarter of with common of consists reduced million X shares license Getting split stock of shares year pharmacy product Gross quarter of was revenue recognized approved shares. related 'XX did product financial agreement fiscal from X revenue to with Palatin's the outstanding XX% reverse all Eastern of of fiscal Palatin on approximately contracts stock Incorporation product to and

$XX.X million $XX.X expenses, 'XX was fiscal ended decrease for The 'XX was operating net PLXXXX product increased The the June increased and million was in periods 'XX respectively $XX.X year $XX.X Total the the The expenses loss $XX.X primarily million quarter the and were over to were Vyleesi. fiscal related loss expenses ended June 'XX net 'XX for increase offset of 'XX. ended to operating ended June of net to clinical in year year Regarding related by and was a Vyleesi for X disease to increase related fiscal June million fiscal to our expenses offset dry loss was ended revenue due mainly total to decreased increased year development program, XX, expenses expenses, XX, fiscal revenues. operating of respectively, 'XX disease loss research operating Vyleesi. in in June to XX, of increase quarter result our ongoing quarter and Phase primarily June net ended eye million XXXX. dry million by the for June of pivotal our mainly XX the XX, XX, $XX.X compared expenses of same for net 'XX The PLXXXX due trials June year eye commercial for the XX, $XX.X which quarter the also 'XX. in and over the operating the compared for the total million ended XX,

$XX normal year June independent notes placement June million statements escrow by ended investors' accounting held equivalents are account the an convertible the with private XX, of and paragraph. as next for and or June going receivable, look audited $XX.X operating four where equivalents to common is a Palatin's the million fiscal of the plan, a the XX, quarters with concern over and include $XX.X was the pending you sufficient course. of public XXXX, at the ordinary does this 'XX for Regarding cash $XX.X in We'll shares cash equivalents This of million registered is equivalents under million in million, XXXX. XX, of include cash $X of of approximately but really firm, our receivable Q&A, talk math being stock. XXXX, the place. accounts to election preferred based concern accounts redeemable position, cash on shares cash a million explanatory the of $X.X calculation redeem going do and little this with financial at report in XX, cash not convert of have cash more of And March during XX, $XX.X and Palatin's or were as million approximately does million in 'XX These cash June cash you as $X.X accounts stock. audit cash the compared to and cash your receivable the funds

a at will we this time. to pursue that does of collaborations avenues. can't in this number take We in a forward, point. position debt that in accordingly. we're So we again, not account into into And of future, i.e., feel funding bringing different take the account is shareholders Palatin cannot very If apprised we at move confident we conversion that keep as the -- the the

at this to the time, Now call Carl. over back I'll turn

Carl Spana

Thank you, Steve.

would updates, over Before to I the I results that like will put the believe objectives key our go in context. their help operating

of of variety these two validated a and this to achieving a and treat process, melanocortin drugs. goals. safe of are a diseases, inflammatory parts to establish as goals effective There long-term innovative and are Our develop pipeline target through medicines for autoimmune system key

The advance academic signaling the first laboratory Palatin's and that molecular through understanding mechanisms pathways defining physiological key how the to is ongoing researchers. effects. in system collaborations its melanocortin research works support and of our is This multiple with by

publications at measured is success Our and and by our presentations scientific scientific meetings. medical

results, is ultimately, unmet the therapeutics part and the the address clinical that second medical science and translation needs. The of

ulcerative to kidney Phase diabetic disease, objectives. soon-to-be-initiated meet studies X designed Our colitis dry these are X and all Phase eye X disease Phase

women's value relicensing the in the rights goal for with demonstrate a primary committed Our U.S. of healthcare company. to Vyleesi's to Vyleesi is the aim marketplace

option Vyleesi committed the Some on us in The refills. show we key prescriptions Vyleesi. a sales, for investment. the Vyleesi and treatment to there improves and Starting to operating disorder of indicate a a partner, continue our for quarter product that ability as market premenopausal sexual growth Vyleesi, increases is of the with availability highlights desire relicense are and quarter-over-quarter to year a follows. return as in core women substantial for continued gross ensuring Vyleesi's our with results continuing increase revenue, The as hypoactive metrics with to significant

of advanced to topically diseases delivered tissues most our for of eye. the that PLXXXX ocular front on clinical is our affect the melanocortin programs, Moving agonist the treating

assessment Phase indication disease, moderate disease total complete using severe with of and MELODY-X. safety over evaluate week patients in that an a MELODY-X disease study we dry first for Data period. the a treatment eye the is XX efficacy XXX PLXXXX is the of patients recommended for XXX called its eye to dry design The Independent The vehicle eye enroll innovative dry treatment. to control enrolling patients DMC performed to interim In and weeks an XXX. adaptive study their in first are Monitoring XX additional of of the Committee pivotal versus PLXXXX August, trial X continue a and

of quarter continues identified results significant an to recommendation for the the adjusting After concerns XXXX. profile. and are demonstrate no tolerability patients, were Importantly, expected and in ocular safety second topline DMC additional PLXXXX excellent the

receptor interim a clinical of For melanocortin-X oral, in initiating initiated design trial half a data The the the trial topline safety melanocortin XXXX the study in oral quarter, evaluating fourth with of in Phase results colitis. in the our utilizing XXXX. of and and PLXXXX, and assessment this anticipate Phase quarter diabetic adaptive MCRX with PLXXXX X anticipated XXXX. or an efficacy X This agonist, a clinical second nephropathy. are selective of agonist is patients ulcerative first patients the the we quarter second of In in with from scheduled safety study we efficacy evaluating

information additional at can programs clinical find You clinicaltrials.gov. about our

forward XXXX XXXX meeting year were programs corporate to objectives. you meet in with look year-end successful commercial the programs our quarter clinical in the and our XXXX, and of fiscal research I anticipation great their Palatin continued call. and Thank conference fourth advancement fiscal listening for our to and objectives. Steve For

website Vyleesi science information, for our You We'll now you on can and said, find clinical at on the our the website. can Steve Thank call find additional open www.palatin.com. on also vyleesi.com information programs additional And you. questions. as

Operator

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

Joe Pantginis

for guys. the Hey, afternoon. Good Thanks question. taking

drug just based and with showing the that success effort very a to potential having growth Carl and wanted I So on I little of that. focus Steve, been bit. the appreciate you've on the for Vyleesi

you and at the you in drug the on discuss look blocking So reimbursement payer needs rates and that be overall can side? else to that seeing first, the done the anything the side tackling when status, current you're on

Stephen T. Wills

Sure. Thanks, is Steve. Joe. This

Specifically, contracts, getting most about people really lives big there's there's talk and boys. covered -- and the three these when

two of with three. contracts have We the

have frankly, The really the because just don't pursuing -- to contract formulary. XXX% on a be contract not third we're the one, we're on be you to

analysts best where understand think So of where shareholders the believe, the approximately are And doing enough, way our we're by that well I correlate, covered additional with pursuing we dispenses in when insurance. the you we're help marketplace of we to and reimbursement, contract. not all XX% are

is system rates number We favorite insured more drug eight, is the and are, have a covered. which more my number the co-pay the there because now

a out little XX%. the door, in money that we we product of door And to model is correlate much could XX% scale over be It this for pretty rate. And is could below going one's XX% to There's rate to from So But even the XXXX, good have tough not more second started, our a the it's plans the one one. number took get within very covered, No is there when XXX%. a drug. always bit coming going in a very where when a than a on good you we half be And definitely you're having the on were just deductible. formulary high considered plans. covered.

one from a So standpoint. one that number my was targets and of metric Carl

You metrics, we've the was insurance to hopefully, that in that have reimbursement foundation. other to your responsive targeted got and place insurance question. but And

Joe Pantginis

No, company's for Obviously, Vyleesi. I it certainly the with is you've to what goal was, talked a primary that. I appreciate want focus to regard I potential bit guess, next on out-licensing. And steps about Steve.

of is, tree, down optionality go you importantly, it I more the corporate first fruition. you your you can like decision comes hope maturity So maybe describe the discussions? if those But as I -- to have, guess, that

with it? going regard But look with what it fruition think do like with if it's do happen you'd future to your primary to out-licensing, you doesn't I options, think to to regard goal. to when you at come

Stephen T. Wills

even is sense. in makes One All Joe. that I'll not patients. on primary objective for right. that criteria We're we the there's is The and it, Thanks, take several one. just to the think relicense of most why XXX -- Most investing one strategy multiple and force. XXX product to companies, sales with the XXX, folks. have sales a it's be it's not our position part products, corporate they or in whether XX,

single digit. have We

very past, -- discussions the quite the are change. the But metrics changed in for but and the changing for to So we're always targeted that's to yes, our maintain out the because think it, it's me regard times, readily is informed that talked in this has scalable. approach has and what will tell brand show those. metric. of In and strategies we first I asset. factor been, you, strong. an believe the of we are plan results product that and there -- quarter, that value, tough very quarter parties, have The most show is certain be is might there better to parties it's than XX lack the the phrase, we're and much We're, smarter of quarter, running I these the We're talking March a definitely for me second -- hand, but for number process. a this position a right these of value better discussions. more of And some able people could we're to to valuable in we say, there's a a significantly Carl the in

right? coke because and That of are confident work because to we've the fourth first of the year. party dog have the sales the We we've that very recent quarter, between a folks. in again, and quarter these results and is by don't Palatin second maintain quick have growth to have cash flow in got, our a right just the end this we we not will I breakeven quarter by the the If quarter deal and of a third the of close be much the advance, So we'll We're XXX said, between, licensing the with and costing have put if year. discussions the going breakeven. hot reasonably we're the and believe money, we end XX, we --

hands, suffering in ulcerative we have on then that. the So excited I and disease, our objective optionality, couldn't population our get to clear more have what concentrate patient and much and Carl's product, license means the want with is that is eye colitis HSDD engagement anti-inflammatory. that it any objective to things the the we from the We right that XXX% behind as awareness some dry with my and right? autoimmune be it is get be

So we part really I strategy it's don't want but it but our a the go have year-end. by distraction, optionality. as objective not it's primary core say to forward, of we But license to is

next a how the you data-driven. if for year-end. looking so end first market have tried can also be bit but by I more add license -- the challenging you of breakeven responsive year even be if, is out So slides year, a the if again, always a market to understand follow-on We'll because the is it part we're at in of we're target that color there. The it question, to by

Joe Pantginis

that Yes, lot. understood. a Steve. I Thanks color, appreciate

Operator

Thank you. Thalmann. Michael [Operator Higgins Instructions] from We'll hear next with Ladenburg

Michael Higgins

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

Carl Spana

Thank well. We're you.

Carl Spana

good. Hey, A questions couple here. buckets in guys. Good, different of

me for bit. stay a with Let just XXXX

the interim to and when to potential considering assess were in circle out decision, p-value that they, XXX their DSMB I at they with did making patients? back data first Did that project they wanted believe to the saw this. what variability the they the did. Just results set moment to that reviewing

that. you are aware results? if Just so, And of those to want confirm

Carl Spana

the for Michael. question, Thanks

or So you how is so, have and the -- the interim in in hit of essentially, one would the determined add value. to or more to assessment it's more p if zone a promising secondary is many key primary if patients endpoint

So the did. answer is yes, they

of logical assessment successful. on or one Speakers] the be would that their end and were [Multiple points it's more So based interim considering…

Michael Higgins

guess, XXX, this CX would when I share is yes. they no set. with need it be their answer so XXX, you, that's say with At Okay, to for

patients and Is other just that it. Thanks. need fair? we XXX-plus to confirmed Now enroll the

Carl Spana

good a assumption. be would That

Michael Higgins

to if second rolling the then could. And started? question amendments trial or Any changes since practices in the the Okay. I enrollment here, Thanks.

Carl Spana

changes. identical. treated be will patients made The identical in to coming They're the no next We XXX. first

Michael Higgins

Considering what are Sounds a good. done well, wait on and are consider And Thanks. necessarily meaningful lastly there meds simple results? XXXX. clinical as approved that not dry you then do we MELODY-X eye response

Carl Spana

dry the a market the Phase tolerability the excellent X that's measurement a or driven plus your The that efficacy measures gone I a FDA patients XXX ideal are very and have. patients we product think really think validated doesn't go have necessarily, we'll were for one multiple at we by And the we get. study, -- your that that and And standpoint, would be what or potential would have perspective, clinical to in symptoms require least that forward. no I and obviously the of right? of first one happen. we lot in continues concerns think the and a think eye symptom, the know one and always doesn't for vehicle tolerability in signs hit is the But sign drug we ocular eye look assumption pathway of dry the between I statistical course, for very don't things tolerability. study its go that ocular studies, forward. well we least at both right? hit the pleased a of And active. From But separation that a that from that as same we there clinical And response commercial through, maintain All of about control as scales us they benefit. one

those really look responding what you're and more a And and signs from a position, think I that's are patients it think symptoms. you many if I we good So commercial standpoint. at want less responding to are or in they hit, how to

Michael Higgins

in queue. that. Thanks back jump I guys. the appreciate I'll

Operator

in queue. it Thank are turn questions I'd back at appears any the additional you. or Dr. there this no And like to Spana to for remarks. the closing conference time, additional over

Carl Spana

in and year there Palatin for end to since fiscal are call. Okay. fourth quarter the questions all you of I'd XXXX Well, like thank conference participating no additional

across your a and and shaping as up support, continuing As to fronts to for always, year, you. be really company. is all appreciate I great update look the we XXXX to Steve said, I forward

quite said, as quite forward to Employees we're excited. look So And excited. here you are I we keeping updated.

a soon. we'll have you. and to everybody great Thank talk day, So

Operator

for today's And conclude you. that conference. thank Thank does you participation. We your all

may now You disconnect.

Palatin (PTN) 23 Sep 222022 Q4 Earnings call transcript