- Earnings call transcript Q1 2023

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Operator

Hello, ladies and gentlemen, and welcome to Palatin's First Quarter Fiscal Year 2023 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. And 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 by 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 at turn Officer the call

Carl Spana

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

Steve Wills

Thank you, updates. Starting recent everyone. Carl. welcome Good good and certain and afternoon with highlights morning,

Vyleesi program to products which marketplace an in committed commercial is with is the for value company. healthcare Vyleesi, a of rights desire to FDA-approved U.S. our relicensing disorder, women’s the objective sexual demonstrate Regarding of hypoactive the goal

of ended prior Total over were net XXXX revenue compared quarter the per XXXX, of prescription an fiscal XX, increase gross quarter product of with and commercial increased the and comparable quarter reimbursement, first quarter a proceeds quarter investor the to combined shares X,XXX,XXX was the and rates, XX% comparable A insurance with also over common of warrants entered November the common our stock. sales with The in $X.XX. the accompanying prescriptions warrants common to over into the dispensed offering stock of shares in over a with for and in offering and comparable purchase ended and XXX,XXX quarter issuing XXXX, XXX% XX% X,XXX,XXX an XXXX. And XXXX. quarter other with June XX% to million XXXX. in few stock increased certain XXX%, net common securities prior price XX stock. a Palatin completed comparable shares prior up of one amounted increased XXXX. XXXX. purchase Gross to over Refill common XX XX, purchase of up dispensed October the offered of to the product proceeds an was million. For revenue prefunded Palatin warrant of to Net in common quarter Palatin addition, quarter for aggregate increase on items. agreement September September million selling institutional Each X.X share quarter On X.X approximately increased XX, X,

The split Directors shares. the shares, stock Common August change XX, reverse of shares from at X.X remain Stock, of XXXX. reduced XXX the our million common the did of million but number shares stock of of on split, the reverse Regarding shares approximately reverse outstanding million number which authorized to XXX implementation approximately X-for-XX approved Palatin’s split stock Board not a of

fiscal the September to results. ended over first quarter XX Moving financial

X.X Regarding quarter revenue, quarter X.X the over a sales allowances, net XXXX of product XXX% revenue XX, and of was Gross accruals. September of the revenue comparable net total for ended million net product product revenue for with consists of of in the little compared $XXX,XXX, under sales XXXX. quarter gross approximately product increased pharmacy in Vyleesi, distributors gross increased to to sales million of product revenue Vyleesi with $XXX,XXX comparable net and gross products XX% product XXXX. sales

related by were of result operating commercial oral million The expenses total increase development PLXXXX, X.X decreased expenses, compared to research our XX, clinical expenses increased September to clinical XXXX X Phase ongoing million, and and for the primarily in Phase X related expenses, pivotal trial a PLXXXX, offset expenses Vyleesi. of X.X Regarding of quarter was trial in the XXXX. quarter comparable to operating operating ended for

foreign currency to of approximately comparable unrealized expenses, total in and quarter approximately September income XXXX, for the $XXX,XXX other the Regarding transaction income quarter for ended compared mainly gains of XXX,XXX other XXXX. consist XX, net

XXXX for operating loss Palatin's loss, net X.X period in net quarter the offset ended the over increase a ended to mainly an XX, product by XXXX net for in the the XXXX. revenue million net quarter was to the quarter for XX, increase The ended of loss September Regarding XX, same due in September expenses X.X in September Vyleesi. net loss of million, XXXX compared increase was

account or the does of to expects closed shares convert the placement common equivalents XX, through cash convertible currently June XX position, as call XXXX. in of now cash and X approximately registered cash Regarding escrow approximately cash Carl? Palatin's of the operating compared private runway with as in this I'll XXXX, September November of million Palatin accounts include net XX.X from million X.X direct redeemable of approximately the pending million proceeds election were redeem XX.X offering, investors' turn of with cash include not and XXXX, and cash million over held At X.X the million million XX, receivable for to cash back stock. XX million stage, of as to an XX, XXXX accounts cash and stock. Carl. receivable, of XXXX. does The equivalents which not the being calendar shares XX.X of is preferred notes September of cash or an million to This equivalents

Carl Spana

Thank Steve. you,

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

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

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

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

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

in in a patients second disease enrolling One trials: eye is currently study X a ulcerative the colitis. are X clinical two in Phase Phase study dry We is and

to initiate are patient disease. clinical will X also kidney be diabetic on which a We in a Phase program, third study enrollment in track

For revenue, Vyleesi refill continued impressive new prescriptions, in to the including growth show metrics, key and all sales, rates. quarter,

Our continuing efforts to increase are Vyleesi's potential to value partners.

enrollment Melody patients readout Moving a enroll Phase X eye down clinical of disease we PLXXXX to first in for XXXX. our continues expect clinical X, the as of with programs. dry evaluating second in quarter XXXX our trial to the quarter topical data and complete treatment

XXX complete the in committee of the to promising that study. endpoints committee reminder, of enroll monitoring a the the data the one This monitoring evaluated has de-risked. more the total The we data and August, patients. studies As indicates first study been or continue recommended that XXX was believe to data study substantially from patients a

Enrollment with data an interim assessment well plan the an in changes a XXXX. the to agonist program program timeline. selective X melanocortin oral X do design clinical a evaluating utilizing and top PLXXXX, the safety patients. of formulation receptor second XXXX oral and we colitis any is of study half adaptive for of Phase not is anticipate line second and of going first the ulcerative is quarter study and efficacy evaluating an in PLXXXX, Our The

this and drug study or nephropathy, and calendar from enrolled patients approved efficacy new patient for with this half first of in been the the should clinical quarter. by XXXX. Phase results study are study has of agonist be the anticipated X diabetic, The next melanocortin Our clinical FDA a will application investigational in kidney disease. The trial be second safety this evaluating the

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

For in Steve their research conference fiscal to I and listening all the first key Palatin impressive metrics. XXXX and fiscal and first quarter would to Vyleesi continue like growth the objectives to you quarter programs continues XXXX, quarter-over-quarter show of thank call. our for clinical to meet

on now to information hand and additional on We'll website www.palatin.com., you. the clinical science I'm open call of Vyleesi.com information and questions. over the find going can our website. back to programs additional Thank the find operator. it can Vyleesi at you You to our

Operator

of Higgins the question from ahead. from first Thalmann. comes Ladenburg [Operator Instructions] go Please line The Michael

Michael Higgins

Thanks, of a everyone. Good Congrats taking guys. couple for the morning, continued Thanks progress. on questions.

your us that be? on can might give second on On update you front-of-the-eye what the indication, an thoughts

Carl Spana

selected not next initiate probably be now, of moment, variety a indications. really the And we patients, potential until enrolling year. yet, haven't at right get can we'll one quarter trials that Michael. to of It with Well, second we three clinical the

it We have quite be data, with really a something [indiscernible] types preclinical of lot related in indication. and catalysts clinical said, we that being be I on may it have plate. But to supports transplantation, mean, glaucoma, corneal in good data our may that

that trials we're think and sit I three have probably think clinical resources the I enrolling. due right what tight now to to with going you, we're

Michael Higgins

Yes, that sense. makes

retinopathy, maybe or Just going edema, to these completed? those diabetic on updated any to three of you're after is those outlook thoughts that, the eye on are follow-up back that pace a regarding similar macular

Carl Spana

that's are of different little since longer. indication [indiscernible] a there timelines substantially Well, a bit

We program we'll that. candidate will probably [ph] clinical [tox] and that's route next on Once final have probably keep of a need toxicology first will decision a the longer-term for quarter year around done, administration. because start we

forward So to the will clinic that continue will standpoint XXXX. but the get go probably a not towards clinical that until clinic, into program from

in but are we of looking there yet, it things One publishing to next be year. that the we half probably accomplish of is, first published the haven't will we

partners. we data exciting our various [to in one little on we really goals dominated previously – novel look [ph] that mechanism directly a may thought. I models, really some based has earlier potential a anti-VEGFs only than is, be of this working and have mechanism is attractive partnered] those will We And that market is there. affecting the do have how bit had to nothing have new think vascularization, quite We huge, by with think that we new

looking will – So, to we'll continue move forward. be do to we

to – looking earlier clinical maybe corporate an also will We transaction. a

Michael Higgins

over the colitis, anything for is That's can just data us for plan would confirm interim If to share and Thanks. then PLXXXX so, are the then data along Thanks. you type just if what seeing with And super could you way? of us, look, switch then? there share it to with us? you the you to helpful. And

Carl Spana

is study a that So study. placebo controlled

safety do is So, we we do data, any always data see see I obviously see we not blinded. – mean

next look year we – our really we DMC So, at that's that. where have quarter the first first of get at in really a the where look

Michael Higgins

post And endpoints primary, then when you secondary do [Multiple or indications results do Speakers]?

Carl Spana

way to committee. the to we what in it, similar at look it’s I did monitoring Sure. mostly going dry data eye The was

continue the So, they'll that is continue. thanks be – – in take a looking look primary you the to are trial that the results That – looking as the and you it's if that good correct, will to endpoint in likely is most a modeling in one a nice enroll. like coming they'll mean they way. and That basic positive have means that supportive, study

Michael Higgins

Understood.

Okay. Appreciate guys. Thanks it.

Steve Wills

All an in right. I'll jump of since awkward silence. have bit that we

I Q&A. think we're Okay. the [Operator having trouble a little Instructions] with

Carl think I – operator. and ahead go I

Operator

have [Operator no Sorry. further questions We line. on Instructions] the

So, to I'll back turn Dr. Spana. the call

Carl Spana

like Michael, and team around thank Okay. quarter eliminate I'd in things working are Great. the hard at here. enthusiasm Palatin you to exciting us you I They for everyone XXXX call. going Well, tell can't Palatin. growth. really have help we Steve for to first conference on that questions. continued thank Vyleesi's I quarterly are the participating your and

lot should be dysfunction. paying a It’s that. skepticism sexual attention got I about people female a of think to lot of

that on shows lot market to I Vyleesi XXXX. having the that clinical at think And up a correct, about really is for that year. going end product not nice We've a to a continue we're grow. what of excited exciting three the of there's in coming by got that's trials doing and things quite it, we're

said, to Steve. that great So, we'll Have being you thank next Take everybody. and care, you, talk a quarter. Thank you, day everyone.

Operator

joining call. for today's you Thank

await on and You disconnect instructions. further please lines. may stay your now Host, the line

Palatin (PTN) 14 Nov 222023 Q1 Earnings call transcript