PTN - Earnings call transcript Q2 2020 | Palatin Technologies, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the Palatin Technologies Second Quarter Fiscal Year 2020 Operating Results Conference Call.

As a reminder, this conference is being recorded.

Before we begin our remarks, I would like to remind you that 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 may 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.

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

Carl Spana

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

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

Steve Willis

Thank you, Carl, and good morning, everyone.

HSDD. ended XXXX, a expressions AMAG stated with January of these respect women interest will healthcare announced needed Regarding review December Palatin's include first approved it another as highlights preliminary treatment and acquired Vyleesi with generalized AMAG quarter assets. Vyleesi, as product On the Intrarosa. XX, XXXX, received or strategic financial of that Hypoactive premenopausal divest has a operational and female Sexual regarding for it to Disorder result Desire that X,

to Vyleesi have and such terminate the license Palatin the Palatin. obligation Palatin. contractual Palatin, commercially by than it's between its use the require and agree In must to be breaches transfer license agreement commercialize has to AMAG AMAG bound efforts to Vyleesi signee to Vyleesi AMAG AMAG the the to other rights assign fails license cure Under and agreement assigned event AMAG obligation reasonable license to and expressly Vyleesi. potentially this to a could If agreement, the Vyleesi right materially breach,

America, advancing and approval. to those the Pharmaceuticals Both executing clinical territories, XXXX. Fosun the is agreements currently advancing outside, in South are for of during respective calendar Kwandong market and are we conduct to filing we anticipate through in territories territories collaborations, multiple which companies the prior Vyleesi Korea, licensed includes licensed in regulatory Vyleesi in North territories of and for China the Pharma year certain Vyleesi Regarding process Korea. China studies discussions

and expand other under Vyleesi presentation. during to will programs respect his Dr Spana development, these With our portion of the on

financial quarter the XXXX, the of and the related ended XX, recognized over ended XXXX, as Switching shared December agreement regarding for $XX,XXX revenue XXXX. to we revenue December in ended Vyleesi with months reimbursement revenues to no XX, license quarter our recorded There AMAG. costs December XX three for were highlights;

XXXX. the ended X.X operating our in Greenhill Regarding X.X of quarter mutually million termination December operating expenses compared & increase mainly the due engagement agreement was The to were in agreed upon operating million for expenses, total XXXX with for $XXX,XXX Company LLC. of to expenses the in quarter connection made comparable XX, payment with the final

XXXX ended XX, compared is income, primarily the was total total the $X,XXX $XXX,XXX income of and to for income other quarter in December increase of Regarding to equivalents. cash income cash on The for related difference investment our the quarter other comparable other XXXX.

million cash, Regarding XX, receivable million and June Current at XXXX. XX, December X.X million million at compared compared June X.X September XX, equivalents in September XXXX accounts position XXXX capital, XX.X to at XX, XX.X XXXX December were working at million XX, at our XXXX to were and cash million XXX.X XX, and cash liabilities and XXXX. X.X

funding at equivalent and our cash calendar December at us XXXX cash XXXX. support XXXX and approximate planned programs little million position to a least through sufficient Our gives under calendar XX, XX

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

Carl Spana

Steve. you, Thank

Providing Desire to treatment. as a or needed treat update Hypoactive Disorder class operational I'll effective first the HSDD. Vyleesi, premenopausal the and agonist the start products melanocortin approved by the with only safe needed Sexual women in as and FDA

its review, it by announced Pharmaceuticals of and divestiture of As commercial licensed January, Mckenna, Vyleesi. commercial a the potential Vyleesi, strategic it aware and birth of strategy it's viability from value Vyleesi preterm Palatin not all which uncertain that North AMAG's on result are will change medication in is for the I'm AMAG and America. divest based on XXXX you planned of or sure, exclusively as premature

AMAG's divestiture means North Vyleesi new we Vyleesi. will for have of a American that partner

As Vyleesi earlier agreement Steve remains Vyleesi appropriate through are to this on ensure said license to and protect under the rights we value that the process. steps call, the taking all intact our the

we commercialization understand robust realize to that we potential and said, support With to can Vyleesi that the a is divesting a of committed will ensure their for Vyleesi program North partner AMAG's that efforts being new real reasons American Vyleesi.

AMAG In prescriptions the remains specialty Vyleesi initial nationally Based launch Vyleesi potential. commercial data belief direction. and information pharmacies. late additional ongoing collected, AMAG's to significant committed under Vyleesi processed by made two commercial have we the available we being that with XXXX, remain on September, by strongly has launch

Pharmaceuticals partner, Kwangdong of partner development advance working Fosun those South and towards are filings. Outside Korean Pharma America, in our Chinese North with regulatory to territories Vyleesi our we

other a and that to approval AMAG's Vyleesi to actively the license of of territories available territories. all believe in we are impact for commercial ability do interest evaluating FDA our With divestiture engaged multiple not territories. Vyleesi, Vyleesi with We now grow are will unlicensed major that the for Vyleesi continues potential on have partners

into best are identify and executing We Vyleesi partners agreement. working licensing Vyleesi commercialization additional the to

of pipeline stated, full maximize return on Vyleesi on will Steve to XXXX. We is have done our strategy investment partnerships end the Vyleesi believe our territories major our all and us goal the programs. licensee resources our calendar our As by year allow to focus for

quarter, past are the system and of melanocortin programs our immune on in the underlying science in and These regulating responses. average inflammatory on, the based diseases. programs resolving inflammatory research we autoimmune pipeline and work our in in advance continue to Moving

ocular interest the diabetic programs non-infectious treat three we targeting And disease, We in have ocular system melanocortin specific have and dry active a to eye in retinopathy diseases. uveitis.

solution irritation, program dry study our also which dry eye of is dry means PLXXXX between week. screening that vision, known A causes will disease just conjunctiva PLXXXX eye this later that beginning drops report the redness, topical and eye cornea, resulting ophthalmic believe to clinical the excited Phase begin the blurred Dry patient X in PLXXXX trials. the are affects We eye we that underlies disease, will the locally, aspects many system disease. and sicca of reduce keratoconjunctivitis melanocortin are varied inflammation pain activating by of as

compared discomfort the and with study arms. in Briefly, to the placebo is Phase dry placebo ophthalmic There's patients enroll weeks corneal efficacy targeted XX patients controlled patients randomized two two end a eye at primary to study disease. week X points treatment. pre study at XX. XXX of challenge screening post and go a and period inferior want for to are patient selection controlled The environment staining is day a randomized evaluated in fluorescein to safety solution XX PLXXXX evaluate measured ocular adverse This and day

Data additional advance be there Phase exploratory and the details expected website. will endpoints. ophthalmic PLXXXX study be clinical multiple data of a the solution are required this is provide In secondary to available study A the on pivotal addition, studies. the to in will of in trials.gov X from available study quarter XXXX, fourth successful

based X penetration of of XXXX disease treatments safety substantial market. represents believe opportunity potential We efficacy, billion allow dry eye market on growth favorable the dry a and will for patient over for profile continued the market in with demographics. commercial tolerability eye annual sales The substantial and

significant include shown receptor pipeline both ocular and PL-XXXX, models other a retinopathy selected uveitis. agonists efficacy disease MCR the to and the treating subcutaneous Our disease animal melanocortin-X for process. have treating compounds melanocortin-X potential diabetic X affect preclinical non-infectious programs underlying PL-XXXX for agonists The and

the conducting study the of in of required clinical completing research XXXX. are we preclinical an IND and Phase X a development activities and objective principle to file PL-XXXX, For studies and begin proof with starting

and intend which diabetic work retinopathy For have a X conduct commence XXXX completed the as designation of PL-XXXX drug uveitis, study we the after study. in have non-infectious for treatment following non-infectious for requires clinical studies. We data in Phase uveitis a the reviewing orphan to also clinical all received we IND

as clinical oral colitis treatment formulation our programs, We've have and completed a to addition PL-XXXX trials. two diseases. inflammatory ulcerative an for other pipeline X In developed release for bowel ocular colon Phase PL-XXXX we

the dose [ph] admitted was multiple first ascending subcutaneously The XXXX. [evaluate] single ascending a and combined safety systemic study

The the delivery colon oral of PL-XXXX. pharmacokinetics formulation the evaluated of study and safety second

in the oral a with advance ulcerative into release with Studies We data colon mid position are to X now Phase to colitis study, clinical start proof in read anticipated calendar principle calendar formulation. XXXX of XXXX. out mid in

on study supported We start A has two regulatory will research the received natriuretic be a Heart by that peptide programs by approvals conducted we will two also PL-XXXX scheduled research in anticipate to and the Association The the two system, centers. peptide XXXX. selective American receptor acquired trial sponsored is -- a trial major our medical agonist by phase begin academic which naturally have are

Although PL-XXXX, still dual A treating fibrotic excited natriuretic diseases. and C preclinical and potentially we receptor agonists a cardiovascular were compound our are by peptide

of studies last pulmonary encouraging completed liver and Preclinical PL-XXXX has year, fibrosis fibrosis results. produced

there and Our positive complete studies an in begin file these models studies. to FC to begin additional of XXXX preclinical and required clinical -- disease activities development plan to is for is the fibrotic IND if are preclinical

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

to approval of current in the Vyleesi the a of validation as development melanocortin by advancement revenue gives and a In and sales the our Vyleesi are December drug as licenses, from potential closing, and autoimmune the the of programs. system excited XX inflammatory cash of strong development believe XXXX provides pipeline that melanocortin million we target and stream our We milestones new XX, growing us the for exciting programs. our of sheet support balance

to rights the the calendar on continues grow. be ensure license In appropriate intact and our of to provided remains focused Vyleesi the that agreement following, American to steps North year Vyleesi by we'll value taking the XXXX, safeguard

to towards continue to Pharma support licensee the Kwangdong to to work and regulatory the We Vyleesi that to flexible development move advances to and their additional rights objective commercialization will Vyleesi they territories the and committed as product. the the in Vyleesi is the We'll robust submissions process commercialization ultimate of Pharmaceuticals American continue of be execute North with work Vyleesi the Fosun also agreements. divestiture as opportunistic of

filing to study, in begin programs We'll to Thank dry X an the advancing pipeline with to eye PL-XXXX the activities also Phase of IND you. advance X final Phase in our PL-XXXX retinopathy. clinical diabetic and start colitis continue the PL-XXXX ulcerative the

now will call open We questions. for the

Operator

Our first question Newman. John from comes

John Newman

question a Vyleesi. had on Just

there's timing if timeframe that you is curious. So new are out the different, [indiscernible] thinking terms are or in in specific I'm roughly just of that agreement partner if curious sort AMAG -- it's and that just a about the of was locating speaking, laid if just signed items if I you any for

Steve Willis

the Steve. John. for Thanks question, It's Sure.

with divest Vyleesi This publicly and Let's Intrarosa. based is be forward strategic clear. moving AMAG they've North to discussions has the have and second and they are The licensee the they American in first in AMAG's quarter calendar decided advanced or that on the factors, this by divestiture the stated sometime process. quarter process year. of of to hope something completed or end

of next Palatin the We the but if licensee, very advancement with the we a are has for capabilities, move want this will supportive well also with to partners, care get is that accordingly. but health We with AMAG committed and is, process. about the commitment, to brought longer forward. AMAG potential the North sure owner the we into capabilities the make the it no the that talk cooperate We licensee company to product, North right? it's along that's female American of of want if Vyleesi, You also discussions America is process

the of So [indiscernible] can be Vyleesi achieved. of value

being early We their June hope and conference fiscal having a AMAG actually this anticipate until year-end, March. XX/XX a XX, that will with not call be we're

a So divestiture granularity they anticipate will the process expect that at time. we would and around that give lot more

John Newman

Vyleesi know, and as and statement? full place active, accurate an is for Okay, great. activities that And the promotional far in support you remain

Steve Willis

answer Well, think that's that's I that an accuracy I lot question AMAG mean, statement. -- a standpoint. That's a a can better from

is going that going if not in the the a product to you're forward divesting it. they're they you're moving that forward is surprise. on product at that investing It's conference, was [indiscernible]. the on moving a as greatest stated value for which forward owned be JPMorgan are different a program And than We not with aware that

the expect anticipate So on get where AMAG that conference process. And is I the March again, we regarding we'll would granularity the more bit and that understand process early a divestiture in call.

John Newman

great. Thank you. Okay,

Operator

Wainwright. HC Pantginis, Joe from comes question next Our

Joe Pantginis

Just following up on Vyleesi, mind. if don't you

comments So you it forward this mention prepared your did in faith contract. to AMAG's under requirement about of early process good sort the in move

product and that guess timing actual stipulations have would a is of divest contract? to to breach regard what there, recourse in contract your is So, with there potential that any define the I the they is

Carl Spana

specific timings are There divestiture. a no to as Sure.

force, interest it think to as in people. not not They released practical yet a force terms, possible. our have their Joe, quickly sales to their of I as have Just they any it's in its sales full do knowledge,

out that So, through and save required save At they're they force the they think people the we in detailing doctors order sales have cut know to When will the some relationship in as divestiture to have. may product that back. are the contract expenses began that a vis-à-vis potential that the point to to we with they to might they more them that position there, put Palatin and difficult do do. the

they do expect do So to. although they're as direct as because they quickly timeline, kind would of can want it there's no I

Joe Pantginis

give mentioned those as where Fosun a Kwangdong, each into being obviously, stand just territory understand. No, you Vyleesi you and to get the And more little Thank since detail can of able to I market? maybe then you. to

Carl Spana

Sure. to are in should anticipate the done end half in before in countries, fairly submissions the have of look requested their year they at is the multiple studies do patient additional the populations, with that following which thereafter. of Both and be discussions completed of they pharmacokinetics with predominantly and They starting clinical small shortly protocols authorities typical various of. and in those we we've those in a product to first regulatory studies, those year the are part had been countries and the this which them of would

Operator

question from Michael Higgins. next Our comes

Michael Higgins

Couple could. on if Vyleesi, I

that If and numbers roughly look still X.X past us Fosun I million. still an in is or this should and give [indiscernible] if Are you Kwangdong we accurate from million the in on, believe milestones really can mentioned update those XX, not. X forward you've of from timing? in

Steve Willis

These timing accurate. early related related be milestones in part is the The The China China the are to approval Korea. question. thanks latter the is X.X Steve. are million going for is of Michael, the This The to to numbers 'XX. XX, milestone. of part South and regulatory larger to

Michael Higgins

and And the something is and helpful. and contract properly where here that it developed on And on and that Thanks. happen is back came That's the got here given it happening Okay. was it. and paid with towards. question like, for working them. how need with, timing Is it good argued be? a clearly asked question to There's were that's they had that's they Joe a could uncertainty essentially wasn't being It back sold [indiscernible] it then structured the settlement. A in sounds also AMAG. drug precedent they're past and this if marketed essentially something that here the

Carl Spana

They would to That to take believe wither. tremendous we on that back that's are not we'll tremendous as it company just to and to Look, are, we Carl. take for committed we And better we belief This selling into weren't a value is mean, this didn't we it's do. not is and product and comes to that I larger Palatin Vyleesi. the a go as with afraid work words, that certainly of what certainly of we we let breach grow party step believe absolutely there's We are out. the are the it. means down realize let this reiterate infrastructure. strong believe -- was committed will don't it product me their let here going divestiture. product be the preference there unfortunate has It And a that Mike, not and then it. it course was our to up to potential it. this that that. But resources is AMAG a that for commercial partner until

to are it. protect We going

Michael Higgins

Right.

develop does So if sales be come your back it force. own would preference then your internal

So somebody let yourself partner it else? with versus

Carl Spana

have and if infrastructure that's we say out will I I commercial us, that, going to be, support the plan, thought Suffice to able very, that growing we it. act the been to worked well which the case will include articulate to and eventuality. and it and If that and being for does Steve working have think, back forward a have will come on and product

Michael Higgins

Okay.

actually re-partner what preference you'd hearing it's rather it So a is market that than I'm it?

Carl Spana

We take keep at I think, sell I remarket wanted how can it. or back. it demonstrate be point not think or Well, this we would we it whether before would to and would we really this product great entertain it

Steve Willis

Steve. Michael, it's

that that, back onto that's it would sequential strategy. The you'd strategy potential the have show be -- the relicense it with a would value, be be be needs point because giving plan consider. a six to have that then four just with commercialize right? strategic to product quarters value, and forward would it attention scenario If certain But and quarters, bring to add it approach to to grow if greatest moving future to and to can't the Just that and the you in this the in, that at another it we the build it's the would that initially transpires could to sequentially, be scenario enormous.

Michael Higgins

this, Vyleesi very having makes I That's to didn't fall launch see you're Okay. earlier last any revenues report That this reported Q and sense. obviously know Thanks. the despite helpful. in than we AMAG.

to there of -- in calendar is restatement reports it, report revenue? expect QX one a lag a the QX you AMAG forces do future, continue of or kind revenues that the quarter So potential of QX to

Carl Spana

numbers. reporting, I not withstanding quarterly AMAG's we No. mean, do get

warrant any to reflected what material that not to type not going be restatement. going it's of -- enough a would is there So it's a change, if we're comfortable with be that we've

strategy launched has no AMAG a appreciate no per pack charge script the That's consumer. the market way just there's there's understand the for that which female. to script. the want first doses four entry you the think kept product, need the are has to and AMAG I a at by barriers that They to set that $XX into the ensure up. Subsequent is

course standpoint, go throughput. in in, the number dose, female. cycle the script, fully first quarter a has the which that with we to four-pack going of is There reflect. you're a royalties, because revenue just We the with just through first from the the September, not launch a So starting late that include it's will be expect would through will significant

some of the And earlier AMAG conference numbers which expect expand we first as March. mentioned scheduled more script, quarter anticipate in call and that would will i.e., for I the the launch around believe granular is upon early I their

Michael Higgins

Okay. That's very queue. helpful. it. guys. jump Appreciate back Thanks I'll the in

Operator

at are queue no the time. There questions further this in

Carl Spana

Great. the insightful to you Thank where the hopefully questions help call prospects to to are questions the you. forward Thank move for updating and the you quarter. our participating We're about excited Thank second very clarify going. you look company we continuing on where forward. quarter we to look for and will everybody fiscal Palatin. for and We we're next forward

Operator

gentlemen, Thank today's and concludes this you. Ladies teleconference.

disconnect. You now may

Palatin (PTN) 11 Feb 202020 Q2 Earnings call transcript