OTLK - Earnings call transcript Q3 2024 | Outlook Therapeutics, Inc.

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Operator

Greetings, and welcome to the Outlook Therapeutics Corporate Third Quarter Fiscal Year 2024 Update Conference Call and Webcast. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] It is now my pleasure to introduce your host, Jenene Thomas, Investor Relations. Thank you. ahead. go Please

Jenene Thomas

not At and listeners Donna. involve state I'd to resources. trials forward-looking including, like intentions, the are expectations Thank of These sufficiency timing remarks this and of made risks our clinical but projections, future that expectations commercial may and to, during remind uncertainties. our beliefs, about launch you, and or time, limited the this statements management's cash webcast our

the expectations, this safe securities materially. on are results call the based pursuant to could provisions statements federal harbor Forward-looking laws on made of Outlook and differ are and Therapeutics current actual

As a any on result, reliance you not undue statements. place forward-looking should

statements Therapeutics These documents actual Securities Securities to could review section and Exchange Some of Commission. from that you files and carefully. these the website. company's the Exchange encourage in available the differ results of factors and periodic to reports discussed the with are website in We such the documents Outlook these Investors the cause forward-looking are materially contemplated Commission's by on

webcast information from to the in own and third-party this research. data studies, relates and certain Additionally, on sources or is obtained and estimates company's publications, sources contained based other

accuracy information of verified these completeness to sources third-party fairness, While third-party is the company of believes of independent be the reliable or from any any this independently and or sources to sources. makes adequacy, as the as verified date at not it presentation, obtained no representation

measures release, to Therapeutics measures, included financial principles. reconciliations been the Outlook the available SEC third of in with accounting at and accordance to discuss the with has During Definitions GAAP is direct the on quarter's the comparable in prepared call, financial non-GAAP generally management measures, earnings furnished financial most website company's which not which non-GAAP ir.outlooktherapeutics.com. are are will these accepted along

of Therapeutics and call now Outlook Joining Kenyon, proceed. Chief from us Russell call turn Officer Officer; the to Executive Outlook Please Financial Lawrence President like over and to Trenary. leadership Chief are the Therapeutics. team on Russ Trenary, I'd

C. Trenary

and thank Call for you, Webcast. quarter us Thank to Conference XXXX fiscal you joining and everyone third Janine, our year

begin to and is it's first for of call, the our U.S. me ever We're approved for that simply in for an advancing treatment and U.K. Union in quite toward mission, European initially with Kingdom in I bevacizumab real today's As received the We approved and achieve authorization United and ophthalmic launch markets. of we approval important mission the to the achieving that of for ophthalmic retina time. diseases, think toward EU, bevacizumab formulation already wet key treatment are marketing both in the first the AMD the working of the those start

the here as successful, which, We're BLA basis resubmitting in serve States in our quarter clinical to in minute. with for also making will United good the occur EIGHT which if trial, first More that NORSE on a the with of XXXX. FDA, ongoing our expect progress calendar the we

a culmination with regulatory decisions is years. all hard colleagues past these and the Kingdom. of Union on and and several partners very United Focusing the believe striving the our from to have We're the work both bodies been pleased achieve this European

conducted and the the have we we data it studies completed. clinical CMC validates I to think we have work speaks also generated, the have and

as for to which market largest can represent the X in everything we to We combined are to AMD many in these this possible patients do territories, as bring the going important wet drug world. second

half of access calendar planning market the and work commercialization. We're inventory and in those Germany markets the continuing with and for product availability to U.K. XXXX. expected turning Now in first

infrastructure, organizations to the in with established EU. have that and discussions continue EU continuing partners we'll evaluate are we Additionally, potential

U.S. the to Turning

NORSE non-inferiority as the EIGHT X-month enrolled. We XXX have NORSE efficacy endpoint. planned, XXX that's EIGHT planned we our and study an of on is to make a progressing study, subjects progress XXX X-week continue currently with --

before to the the to complete quarter. third expect continue end We of enrollment

and Top should positive, the sufficient U.S. from quarter line resubmit provide BLA calendar data clinical first results NORSE to the our EIGHT XXXX. year, of in with the expected if FDA are fourth in quarter this

received In C completed and CRL. items and our addition, open we the believe Type with that planned have D we've Type meetings FDA CMC the addressed the were in

our it's pleasure Larry to Financial the Kenyon, And turn my Larry? Chief call over now Officer. to

Lawrence Kenyon

Thank you, Good morning, everyone. Russ.

the saw of we outstanding in our During notes. a further the most convertible balance recent quarter, reduction

the today. have approximately of $XX.X Additional note in is the balance into common stock conversions of outstanding as million continued July, and

On with $X.X convertible at per convertible $XX share. per balance million the is balance, at share, $X remaining another the remaining

$XXX XX, warrants, should exercise be June sufficient expected XXXX when combined shares calling the warrants full of from stock, proceeds meeting for million subject with million the cash to XXXX. support the Our calendar these position of common operations to of requirements through $XX our purchase of to

for results we of quarter XXXX. adjusted that X third I a in the report can Moving fiscal reduction loss net from XXXX. saw on our fiscal financial quarter to of

to calendar of incurred R&D in we versus Previously, XXXX. we most total NORSE QX. a fiscal initiation that this current to fiscal cost QX expenses EIGHT, quarters completed these during NORSE the with we X during activities after first decreased estimated EIGHT be of majority year of of expenses $XX quarter complete the of the had the million reported

these our expenses for the changed next R&D NORSE continue at We run quarter. will not EIGHT, and expect have levels overall to for estimates that

over the we expenses operator QX Europe fiscal call I portion. as increased the quarter. Q&A to for incur in prelaunch to G&A Fiscal the now most recent for QX, expenses the back compared did will turn

Operator

first Harrison of is now Today's for BTIG. Thank Instructions] is floor coming questions. you. question from [Operator open Julian The

Julian Harrison

there are details you you more point? in quarter to on on this quarter regards along track completion able for with understand NORSE is more any how just third could of I later But EIGHT, enrollment details are? First, you in granular -- provide year. the far at share to still this any calendar

C. Trenary

Yes.

minutes, in And enough believe I of think screening. we right we people Julian, now, screening to that and that And this XXX XXX. enrollments. X us dozens rate how actual to in on many were of of got take in yesterday, see -- track are or course, we've we to it's convert worth those that noting, at of got we've today to of top course, patients that screening

So third we continue the level that screening and to expect so can of to we end before see the finish a that good enrollment of continue quarter. comfortably

Julian Harrison

is become Very in when enrollment to But 'XX. guidance you guidance precise then once your NORSE that more understand completion confirmed does for EIGHT, resubmission? to to BLA XQ be confirmed? easier it when updated specifically helpful. guide I completions Excellent. in become And enrollment easier does it expect

C. Trenary

I is last Yes, yes, the of think is when because and last time amount predictable. visit time there of amount between to treated And is and known. their scheduled lock clean is database the the the patient

we in down we that to position completion will once be know enrollment better So has nail a occurred. yes, when

Operator

The coming from Brookline next question is Will Capital Hidell of Markets.

Will Hidell

the about I process to by question going assessment I NICE. they're have process? delivered on there tech U.K. think know maybe that a with any Is Quick updates December.

C. Trenary

process have really together NICE, that we're believe update through to accepted with I the them. well-informed we a we only we application. the and They've our dossier think put going the -- is

be terms going know market. and pricing we're what of that in exactly type in we'll that year, of utilizing through the like we'll the later that just process, that And in so looks

Operator

from of Tim One. is question The next Chiang coming Capital

Timothy Chiang

XQ Russell, meetings to the just type the the came bit extended could D of filings of you little talk FDA? with the noticed what out you C year. about timing a of had and that I next

and I pushout correlation the just is FDA in between any the filing? the So -- discussions with there your

C. Trenary

the us design meet we Type of really what back they meeting the It's they from had questions the look there. discussions Really with the around the The first additional trial around associated the A they to what timing with them trial group talk encouraged clinical that on their to solely that during had prediction FDA, like, CMC come of the after None. enrollment. would in and on course us, meeting our focused during to filing also -- that. of encouraged is aside with having completion

So we that took them up offer. on

And FDA now very think have on characterize I that had they would -- FDA I been as with question And list. we've with we single so CMC our think every the reviewed discussions positive.

meetings. really those at we're we're so we've continue we'll going to we're answers a of but CMC happy say those to to to completed And point just on finish And work, where up the some publishing questions.

So out. how we're that satisfied quite turned with

Operator

The of Wainwright. from Douglas H.C. is next question coming Tsao

Douglas Tsao

terms in first the the fourth filing noted, you're so of BLA versus Just to the of now has quarter. guiding the of sort timing quarter curious, been

the get where was pace is anticipated? you just and And led guess my that sites did as is result Just patients of up the not quickly just what you little quite curious in? exactly a coming that? many And as you expected? behind Or maybe patient of enrollment running as maybe to

C. Trenary

Yes. had Thanks, by or able think finish by of to end of the Doug. hit timing for be I us to year, the to -- the would Yes, that to resubmit to the BLA enrollment year end July. able we be have end enrollment of

average. the enrollment predicted. talk -- Xx about that site Our doctor per be industry than the is industry people that's faster a it Most per patient what in current pace should that about to takes

going of us all to enrollment finish to the then have by the end And the the we're taken if were to that of case, so third it Instead, would end way quarter. year the enroll. the

-- end really think into that terms it but submission. almost does July, going hit hit. BLA in we're to year going of because of of I I it aggressive next to just So was did puts beginning we not -- us it it's the goal a think But

Douglas Tsao

Okay. are launch for what of for of the well? launch, potentially in that European inventory than European launch? the provide kind And investments I'm in supply Great. U.S. making just is terms curious the you going terms of to as And

C. Trenary

we inventory for Yes, -- last into we when expected from of approval August it went actually XX could. year had some ready FDA. We

for area States. to and/or the So still is sale there, European United that available in the it's and in sitting going inventory be

built And the is things life shelf to we're of I think able extend to about continuing one nice of having that inventory the be product. that

So by we're of XX year, of expecting that dating product. the and on between end the have think months I to XX

work shelf that's the on of being just think and is stability really tracking extending life. right that's I done now kind So inventory

Operator

Gataulin coming from is Daniil question next of Our Chardan.

Daniil Gataulin

have dynamics and all the after before Europe the items and the now in for a launch change the does as launch on first checklist U.K., And in the one. the off-label a EU what commercial assumptions there approval [inaudible] are the how quick launch? or I list on current progress. your in Congrats between and use follow-up, half?

C. Trenary

Yes.

to X different the terms or and use, in are compounding. are use is the Europe those following There repackaging it's off-label off-label not situation law, close allowed. because So some market. in of where the people -- by really markets, not is markets in And market they're

I tolerated of other its In markets, having It's And that unlawful, doctors molecule from also from the payers bevacizumab it's hear for it's like is thing of we they only think the is that source but kind. available. and a now.

so least blind time, And eye little of offering products. bit they'll on a turn for off-label at a

bevacizumab conversations approved, the -- drip that to and doctors to think the different once IV. standards I we So that we the we for that and that treat the and have developed it. and I have oncology indicate live with a we've be that they to through in They in that research bevacizumab to that we our standards delivered think understand trial, market customer our are get are designed payers, used and originally was that the that had have clinical the versus product was lived

They same requirements oncologic in the don't for validation that use ophthalmic version have they're approved and for comes standards things those for They or that don't meet for the need of packaging the they same syringe ophthalmic particulates. meet levels. the -- So same for lack endotox -- pH requirements They ophthalmology the utter have standards. the oncology vial don't standards requirements like from don't have for don't levels. not

payer ophthalmic off-label of that bevacizumab an approved a to and So provide of compared version the whole there don't host that the are bevacizumab. customer things

vial, while So them on for position to from the think we'll the based can on standards. a validated ophthalmology In away, upon the is off-label compete of based we clinical go those think be markets to all we in. vial with that go data a GMP that where on by of quality, takes a based having protein meeting amount in syringe And product the we great and that it repackaging right drug effort. by based comes concentration, syringe out never

right price where little very point a But bevacizumab. we'll product be by position off-label us the different think competitor able it's profile, the put the right So right market I and against a quality market. level in of market, will a

Daniil Gataulin

the the And in in for 'XX. on launch of checklist terms of the assumptions first half

C. Trenary

Yes, we're it's really access. -- own engaged so basically, now right we're the in whether work our the hiring market is that

hot with of in health they're to assessment the is payer it of the We're availability. talking terms we're pursuit what in to establish Germany to NICE. same that in that looking talking We're So groups. technology counterpart pricing and for community

So the market first. That work access to be HTA has comes work done.

they've an showing good help bevacizumab that, available of going and communication required that's approved difference them understand symposia up had today. In we're of really addition at conducting trade what the the with retina to the what is them versus with shows, between to community doctors real some ophthalmic through to process doing the

having love have research doctors approved All version. market do ophthalmic The regulatory preference points those a that. the conversations. a We to for

to we're that in engage continuing work. So of all

then step ground, to whether And medical so-called sales in the the partner scientific put on conversations can that take it's it's a whether so customers. the final force appropriate with place be, the a own will liaisons, group the make of decision be or to with a MSLs would our

Operator

At this over floor Mr. comments. Trenary to closing like to turn time, would the for I back

C. Trenary

the much. Therapeutics. look, to believe And to our for a have potential Thank Well, really months the of next Outlook company. few you exciting continue so this the Great. is we time profile transform

second talked with market about United to in in preparing advancing inventory and the the we're Europe, authorization Kingdom, largest we in So and market potential actively for discussions wet initiatives, key AMD, today, the marketing what we've markets. received to partners EU summarize and are launch these product in access

with in Thanks continuing this to line retina for of so In report early today. on NORSE bring progress space. first and the EIGHT and calendar resubmit opportunity to for the quarter top BLA enrollment remain level the this and enhanced us an We U.S., calendar year much we track look to our joining results to XXXX. expect care anti-VEGF forward

Operator

this Ladies and concludes gentlemen, today's event.

webcast, disconnect or off your lines may log time this at day. rest enjoy of your the and You the

Outlook Therapeutics (OTLK) 14 Aug 242024 Q3 Earnings call transcript