ABEO - Earnings call 3 2023 | Abeona Therapeutics Inc.

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Operator

Greetings, and welcome to the Abeona Therapeutics Third Quarter 2023 Conference Call. [Operator Instructions]. Please note this conference is being recorded. I will now turn the conference over to your host, Mr. Greg Gin. begin. may you Sir,

Gregory Gin

the Good everyone I our for conference at release XXXX Ali. available results welcome our on third like and update website announcing press The thank joining call. quarter morning, you, 'XX would is everyone. www.abeonatherapeutics.com. to quarter third Thank us on

to Before projections statements. and like remarks during note start, we would today's made forward-looking that I call contain may

on made materially forward-looking results of are statements based expectations the statements pursuant These in securities laws. may expressed safe subject provisions Forward-looking are implied to harbor federal actual are forward-looking to from current and and statements. the or the change, those differ

with section Madhav the that limited Vazzano, Chief are Chief Officer. XX-K and are will call and Officer. in but Various cause Joe joining Dr. the Chief to results today's periodic Commercial are remarks reports could filed Dr. Brian of be Development; session to, differ and Technical Seshadri, documents under not Head identified at for These with Exchange us Chief and Vasanthavada, Commission. Also include, website www.abeonatherapeutics.com. Factors our Vish prepared Business factors those On Dr. Securities available Form actual Risk our on Q&A Financial Officer; Kevany, Executive Officer the

will over I to Vish now call that, turn the Vish. With Seshadri. Go ahead,

Vishwas Seshadri

from continued significant evolving joining morning. a I'm this progress you clinical-stage pleased one us Greg. you you, for Thank update on everybody, opportunity. and our thank Hello, company commercial to with a to

autologous or RDEB. samurai known epidomolysis XAX submission of the pz-cel, or most meaningful history in thrilled for dystrophic bullosa that FDA called at BLA, is the of We with to was investigational at September about. our gene-corrected achieved Pz-cel Abeona's highlight ] start has application, yet formerly the with everyone or me the end is sheet epidermal recessive Pratamagene our Let license milestone Abeona or biologics as EB-XXX. which [

large some a X in and Phase onetime has were the wounds chronic trials, demonstrated years. clinical in reminder, treat after application I/IIa wound remained pz-cel healing treated for that healed run to being a As trial of clinical our toughest

The host transgene the seen ] keratosis, have during to [ COL the transduction we into treatment is ex the integration genome XAX of trivia of sustained effect vivo. patient due

Our not BLA for community I of to potential multiyear order step provide instantaneous occurred the first thank the physicians as Abeona FDA just up art coverage to the whole a constructive from a items this the want onetime who represents vision to but a the take community patients, application. and critical and August. patient towards to achievement, trial, that for moment ] contributed Bay approval the in many therapy X milestone pz-cel [ bound in healing clinical wound meeting months of level a advocacy in with late engagement to and their and who in the for caregivers stakeholders leading vital participated

Orientation I many BLA. entire Meeting recently completed our BLA their with them to like and months acknowledge also our submission Application for to FDA prepare clinical data. the overviewed team over our tremendous would we We through where the our walk termination

application steps this of last review. one acceptance is the is for FDA decides understanding before the on meeting Our of the that formal

made next, our which process during review Regarding goes start submission, out on November. late in whether the what can expect BLA following decision XX-day we case, FDA's window can to the typically is

been by that under review be disease a rare we [ the a remind pz-cel the granted priority I'd the With ] of XXXX. pediatric the could review pz-cel B&A X-month approved requested in designation scenario, to priority second FDA you submission, has grant FDA. quarter

sell review we PRV its approval, voucher on and PRV receive PRV priority able other based we're transactions. $XXX worth million permissible a recent believe to approximately that upon to been has it's to continue potential or So PRV,

focusing commercial team up [ for our the BLA, manufacturing internal a capabilities to In preparing BLA on scaling supporting in [ treatments launch, per our ] site of for of for potential the full for the cell first success patient preapproval and Planning ] PD up currently we supply manufacturing inspection XXX is year review process, year. launch. and to cycles for plan

longer-term Following build launch, further capacity. we will to plan that assess up our

launch. about [indiscernible]. [ note We leadership team PVC draw be I to upon first previous and a the important charging to as first Abeona's commercial of prospects transitioning are that launch Very will therapy for the Madhav excited not stage with will our this ] cytologous with launch product experiences

commercial Commercial for Chief makes opportunity commercial focus Madhav on extensive ] launch cell maximize and coupled experience a highly aspects and now oversee near-term across experience organization is operations -- customer track Officer, and nimble to mortgage commercial the Madhav potential all Madhav and record, heavy [ stage candidate pz-cel. about our the the focused, lead access, planning build-out Madhav? with to of preparations. ask oncology marketing talk will to a therapies As of leadership focus strong sales, our ideal commercialization launching I'll with diverse strategy,

Madhav Vasanthavada

Thanks, Vish.

We the launch pending are, of FDA pz-cel, excited approval. for potential commercial of course,

for might ensure treatment the areas. for bring. that near-term patients centers onboard our X with therapy captures high-volume a pz-cel dispersed two, simply help pz-cel like broad so treat health In and upon can expertise have These to is point pz-cel U.S., with transformative government price prepare they our product all EB at for on working these to would across value geographically caring eligible at is the systems that commercial patients and main and in And approval. centers are the terms One make patients. of a commercialization X act which already accessible treatment EV insurance approach, to X

We our on fronts. are happy far so with these both progress

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very interest received site pz-cel by it. have onboarding we [indiscernible], initiate these from We and to are excited physicians discussions

of with and we incurred the areas a payers caring payers to supports and minimize patients and treatment after provides educate after healing them demonstrate current continue that wound day week coming years value and of caregivers see a of and gene pz-cel wounds standards months for second therapy in burden wounds the With that line day toughest price effect continuously onetime of hope of over the pricing pz-cel administrators care. coverage hospital the respect and with area pain with cell could we focus their to engage feedback application and instantaneous and treat a the [indiscernible] for week will large access trials Early we about and positive pz-cel wound the payer that further from application. engagement, for the by coverage to areas in Furthermore, to in sustained potential. following onetime wound on clinical even our

X with Additionally, are and IIIb procedure our wound in the to of repeat Phase the continue enthusiasm And and ongoing receive community, untreated their nature in the patients clinical elected speaking in our all trial, for again patients advocacy we who trial pz-cel. appreciate patients to pz-cel fully for have hear areas. previously fact, involved

voices the caregivers work sure are we patients, the that with FDA and and presented engage the payers. We with continue well of the families groups will to the as make patient and

our out piece infrastructure Their our manner a fill commercial additional network an we Lastly, access cell We roles, commercialization BLA experience have account and bring will including proven intend autologous since who with and build and BLA organization our and biopharma contribution commercial our aligned launch be quickly moved submission, in with to veterans planning. market launch to crucial have therapies. management, important acceptance. key further marketing leveraged to of stage-gated

discuss Joe Now third I'll over to hand Joe? quarter results. our financial to the call

Joseph Vazzano

XX details on additional would September remind X Thanks, that to I our get XX, everyone the financial ended and for like on available website. can Form results is XXXX. the Madhav. our where you is months X which

remain investments of We cash cash sufficient extends resources July gross review June of assumptions, XXXX $XX.X direct Based of the million XXXX. Starting proceeds the business for launch fourth million cash, current with a as operating and fund on into as XXXX, including of on to of XX, plan receipt September the runway of $XX.X short-term and and our $XX balance of the financial our offering Pz-cel in compared voucher. million equivalents, commercial launch financial resources cash sheet. In our XXXX. had our priority our registered in other as pz-cel commercial words, and XX, potential operations from to restricted quarter beyond preparations

expenses for September in months to September $X.X compared X XX, Research the $X.X X million XXXX, and million XX, ended were development XXXX. the ended months

loss per $X.X million $XX.X September spend ended administrative attributable same was period common the in third loss compared XXXX, quarter on $X.X million Our shareholders to million common share general third $X.X in the XXXX. compared the for was $X common XXXX for loss per to net Net to XXXX. activities and months as attributable XX, X $X.XX of to of quarter of loss or share million common or of a shareholders the

call brief the Vish? the kicking for session. turn to I'll remarks that, off With Q&A before back Vish closing

Vishwas Seshadri

close the for exciting I on enthusiasm Abeona is our Joe. clinical data pz-cel and to treatment to through a you, for community, this believe and ] Arctic demonstrated strong an be we've Thank by BLA With patients. medical option on time reiterating submission, from Based could the pz-cel therapy product like potential [ community. clinical research our ability development. from for important we cell take an our that would

both the launch and pz-cel. toward plan With approval cell entry operator, ultimately commercial open forward the continue potential Q&A positioned to U.S. anticipated momentum regulatory readiness of the to are extensive with in potential launch the for a We're and diverse our months process potential looking We and with on as coming through and experience advance well executing please session. market we public therapies. that, commercial

Operator

Our Cantor first [Operator from Kristen coming Fitzgerald. question Instructions] with Kluska is

Kristen Kluska

you're I early now need of the I/II the And patients on. identification procedures, participants prior you speak for or X of these some that trial some chance involved? was could given be to the doing hoping of any patient elaborate work moving Phase of

Vishwas Seshadri

that provide Madhav, it I for Kristen, you hand Madhav my elaborate. question, over will and to Thank before thoughts

current I as is before prior well of from vital question pace repeat I the -- XXX just are the potential from we're benefit would around Phase how but in your reiterate, on vital, the coming identification say, experience. having anecdotes previous in B we for I/II where for study both not would from I/II and that studies to Phase some our provide the the a And can patients in also Just the is patients study a launch potential launch, going think patients X it's study as treatment. even

launch. So for model for prepare all of patient this identification of specific take augurs the will question well we that. as But

Madhav Vasanthavada

more to [ therapy. think will recently conducted physicians assuring continue require patients one that the that ad we these believe in was board I ] that very than

[ the centers bolus ], carcinoma infections happen. we honoring that with is the the there speculate know it right and look we ] whether gel management, identified nature, in or can center patients to on. increasing awareness risk that is as for wound these longer for the of do being have bring Joe these We to are wounds visit the patients one infections ] by whether and are in now patients who topical chronic certainly the [ [ the displace care So that greater

But in So based who where identifying is their in are out, volume tangible own to already we approval. the speaking get more anticipation are about of okay, physicians, that about gather in that with of minds. analysis patients and are we launch, as can we see what on analysis would claims to and we so find to are we thinking certain continue concretely their and up this thinking formalize physicians closer will them benefit talking patients know pz-cel here from the

Kristen Kluska

ahead. And then go -- sorry, Okay.

Unknown Executive

to wanted helps your answer So I question. if check that

Kristen Kluska

or be Yes, your go yes. field? have you'll assuming laid how able do you that helpful. out in quickly lines to this Very the time And you've commercial think --

Unknown Executive

very So BE post therapies, the have PNC quickly approval, the and place similar after to from payers' we [ at ] to centers autonomous standpoint. approvals then right treatment in medical do approval, visit policies

ballpark in estimation maybe to place. our X have month processes to months So talking these a about we're is

ability of a an be be So as place on, that have have if FDA then soon order we pz-cel. from our you approval. goal will. would will But sort it launch, as physician's our to post we to the And can for

Operator

is question coming next from Our Raycroft Jefferies. Maury with

Unknown Analyst

for On Yao is Maury. This

Our at assumptions in $XXX opportunity. you the target? first be reach you to that commercial to million. question What went that into is sales estimate think kind the said to And do what We about on that need infrastructure conference of the recently estimate? build you terms of peak

Unknown Executive

thanks for Yes, question. that

And as time the us, launch look demand few we have the of as pz-cel, estimate then is In what ] that that so provide of in given like looks ramp a as at patients year. to the terms and that to the CapEx. ability indicated, for we XXX assumptions increase have supply [ around centers, maintain we scale soon our to experience treatment time we can the have initial we over a

the of frame. time XXX in sales, have around year projection a over, think, For I a X-year patients peak we

capacity have sale baked projected the X-digit price we estimate X with And the years. period peak we of point. the a pricing is also a over So have there is in XXX

to are X well patients initial these as come will of patient wounded and require they of each expect such patients site. have in time key successive that rounds amounts average both area that assumption EB-XXX So novo the de these large the that an treatment we the assumptions first as in

Unknown Executive

should Yes. that is we that launch can is excellence any good year just it expansion reasons a of be We're the to a in get will X-year XXX. ramp we I experience XXX of And let's or we will XXX say, initial to we sense starting after scenario, one it capacity. capacity with the expand to if the add, what or we up that at need centers triggering a and onboard of level first and, post-launch XXX

validated expansion I as what we some be opportunity than that once trends. of that our for start think And hope that some is you're I $XXX of so dependent those seeing seeing will a perspective million greater demand on gives capacity and you that. in assumptions peak reason, initial assumptions. the of

Unknown Analyst

Thanks sense. for it. the Got answer. That makes

treated from recently initial and how surprising community heard scripts you that their centers does one about are Cristal centers Or about launch? doctors on sort maybe Another get community of of change or the [ of versus thinking steps doctors your done ] to We before reaching of update report are thinking about excellence, reported at patients commercial. that how half are excellence? actually some you're

Unknown Executive

Yes.

time, be of period of at centers to and or XX to as there we There well apply patients have necessarily debt to excellence therapy. that of over excellence are community from time trained a that or outwards know to surgically then we the will where community patients. as So see centers with [ EV lot present believe ] excellence, centers ability of the centers that which of pz-cel a are of are finally of these And excellence who at the centers. the centers this centers will are that excellence pz-cel centers of some expand patients to of launch, ideal get are we look candidates the don't

to of And have reference educate place. and we centers in so these they could are look that clearly, therapy, we the will aware the so

occupancy group. work that's approach. continue our to we with So And patient

this we particular. where multiple understand We in of given adequacy patient that [ these are with vast procedures. Debra nature we pz-cel apply [indiscernible] majority strong community, have groups, the [indiscernible] centers a of partnership And the ]

going approach. that's be our So to

the then sites those a the a And is for treatment strong are to though where chronically we appetite for be they patients value hard be applied yes, is we is ], treatment, were so think there think would here coming that I have the will proposition are a a versus it if strong. which there from, even to feel in community pull setting, is and the procedure [ strong wounds onetime

Unknown Analyst

Okay. Got it.

one have is trial last going how The think do patients, X-year you think old III X? X-year older, or a Or patients to Phase question. label Just under minimum unmet about age old? you enrolled do needs quick of the in

Unknown Executive

Yes. a That's fantastic that Thanks that. going question. It's a we the for to to will dialogue have be with FDA. have

dose epidermal so that we applied is is so that body So this at if are at, surface body differently sheets. something sheet is percentage you as topically viewed applying look area these surface a here of a

let's a say, X X we've at X-year stature look sheets. to mark, old small to you close and patient applied if So the

In fact, across surface a proportion and XX their the X that a replaced that's a sheet same of body area, the huge we on of as percentage patients have so studies X-year-old coverage.

agency is going ability which a view age baker validated our reason understanding the the in minimal long to is going selected study age why scale, at is because to impact So minimum was above. how endpoints, the was the how to X-year ages a pain for and dosage they X view the report primarily

we restriction. end So had an we that because point, had

with Now help X And that that on you years that to to is is that's the Phase also age as build up IIIb years is limit study below mean or X years old, that therapy a patient the I apply couldn't dropping X current we -- that believe that ongoing experience. that negotiation. going

going of the review we FDA. this the stages get something in approval, is the with by to time that's late So be locked

among graph where the order EV be is But patients and of age that as but these do believe Our than to X say, move younger follow even patient in years physicians, as well sheets we're the are dialogue definitely the XX patients to plastic application a of is of for to that to of that's where age. going months that take much, the safely that types of is what them much have all optimally how old, it's applicable we those X these we age, than if age. currently manage practices the beneficial can types happening because is, what think currently are patients best I various specialist younger say than, surgeons is needs it's anticipation too we let's this to years immobilize answering after lower

to that coming the more topic. come months So on in

Operator

is from Molloy Global Alliance question next with James coming Our Partners.

Unknown Analyst

is for on Laura This Jim.

So on also yet? started process organization we'll been there be for working have you sales building to And out challenges pz-cel, join? hiring have on getting team numbers the any

Unknown Executive

we leadership Thanks, actually, Laura. place talent team the a question, had far. To side. from in no your We've address all issues commercial bringing got at on have second so in

head organization. medical operations have to the access and management market of account the so to look We the person, continue marketing, scale we key

Not a infrastructure whole on don't team, early have we we need that this saying we of -- Because require therapy poll. a is what given been a lot where limited commercial is the right? what is

me with is level time, question interest to when But in sales on at of community bet. teams these So that is the regards We exists launch the educate our that se. may outdoor perhaps we the team the to of over sales don't to a of per sales or bring look that continue to centers. team to sales approval leads initial major part first your having a because anticipate after

contact it's key place, on placed. going team the medical be in We layers where are at centers the a medical also pz-cel point will and have managers science and who to will to have treatment educate of account continue be whether a

managers have, we So to account medical that's is that will on our and teams. focus which model key

Unknown Analyst

[ launch? do Krystal for then to see this particular launch your Biotech pz-cel. And of going for and to this you it. Got takeaways EB back pz-cel comparing ] and What are thoughts overall also BIJUVA they what from

Unknown Executive

been really these for too long, see right? uptake Our -- to far been just on have see no that burden I products, mean, that therapeutic so care, the is they've awareness the we is I great their up. devastating of this have these wounds mean our for standard takeaway are everyone patients of picking happy has subjected treating had options to to had the

number different insurance We that on taking the are in beginning And for number testing approval followers, and I to pz-cel of and are the And and so approach position is as us, payers because two, time physicians and -- following cover we the continue to market, awareness forth, are positioning to pz-cel our positive by these and takeaway getting time clear better that think lines. not to a we comes one, is and be also which weeks a, this weighted. so from for which heard and coming for the was beginning our a is more in these patients just we therapeutic really [ that several copy so up paperwork We've takeaways we in are happy will And are clearly these patients physicians are their learn forget therapies The going do the needed raise are proposition types into all coming these the the to what's the that major happening different body. that genetic there different. The approach are fantastic and very that ], options from because have this different, almost these be wounds means space. value of see for is what fast only helps to patients patients the our access clearance from genetic right? very access. to companies that space patients, is by all very helps

going to for the guns, And and of like instantaneous pz-cel where there. need large a pain be willingness wounds you the lot for closure, the to if may, go is big there's

what we to and long these is take patients we're sufficient exist. So of kind bolus over excellence already pent-up know why structure a on in investing we're which not in of is because centers -- already and why force our patients sales is which learning that's of big

Unknown Analyst

Understood.

question from last Just us. one

pz-cel skin for have past be display used patients. the potential to the sizes or for You to graft different mentioned in the formulated

get So indications these to into you onto methods the trying look when administration additional or label? might

Unknown Executive

Yes.

we job perspective I really pz-cel think product. biological is think finite this hard it's resources management, there be There's at a pz-cel our a have comes going launch the as cycle whether have new are that closer even not is probably from to a been to very we're life spray. whole how with learning. of -- every is yet disciplined some Clearly, focus I in mean, much as getting day. to done we

have we these -- So are ideas. we

the I common a make think some be patients are unmet that? think uptake, XXX. going design and need and there's these that community deformities you being EB-XXX, that's products. hand careful our need be appropriately. the of we clearly, that from these grafts way patient eyes the you further lot part different we and for will because We're unmet can of let's can the get shaped but hear of understand is Miten be are then pz-cel ask that the not we glove we out big for like It's to [ surgeons get ] on unmet a do but these ears keeping to I can let's need launched, for products a going and But to build. our improvements product what and

Operator

Thank you.

would at back for questions Seshadri comments. like time. As we no I queue to Mr. over further to it in any hand this have closing

Vishwas Seshadri

other Have shareholders again and day. to our you listened talk soon. who Thank and a nice have to to In thank you. call, this we'll stakeholders I want closing,

Operator

participation. may and we and disconnect lines at Ladies this gentlemen, time, your today's you. and Thank concludes conference, for you thank you this your

Abeona Therapeutics (ABEO) 13 Nov 232023 Q3 Earnings call transcript