MediWound (MDWD) 26 Nov 242024 Q3 Earnings call transcript

Good day, and welcome to the MediWound Third Quarter 2024 Earnings Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Mr. Dan Ferry of Life Advisors. Please go ahead, sir.

welcome, and operator, you, everyone. Thank market Today, release XX, issued press MediWound financial before XXXX. results September the announcing ended for a quarter opened, the third

You and Chief Corporate Executive website of MediWound; Strategy the With may and Chief Development. today Executive Officer release Financial Vice Luxenburg, Investors of Officer; us Gonen, the Wolfenson, tab. company's Ofer are Hani access that Barry under on President

the open Following our for we prepared call Q&A. will remarks,

during remind we performance, including Act this under I Reform future of Litigation made like are that Before defined to future future statements Private plans forward-looking or call, to Q&A expected everyone XXXX. relating begin, prospects session events the or Securities the as statements would MediWound's business

today's directed report is recording MediWound. rebroadcast forward-looking call of is conference or SEC statements. The risk prohibited the written materially notes cautionary are the factors such and upon assumptions, forth MediWound, release results could forward-looking that assumes statements Although are could statements, update MediWound's believes control results set factors in differ the forecast impact the or for the differ the of and beyond of otherwise. and anticipated company to are a as actual Participants well as materially to filed whether any as supplement company reasonable MediWound. The in information, factors that in those in uncertainties to from forth or the set of press result of outcomes future due to new annual without events to reflected the with risks subject property actual cause consent obligation those and from any based many expectations no expressly the forward-looking

to turn Ofer call MediWound. Now Ofer? Gonen, Chief I to Executive Officer of would over like the

progress MediWound to our by a morning, This that appreciate meaningful quarter I for contribute to quarter the MediWound's to today vision. discuss growth good joining marked and performance strong Dan, XXXX. realizing has closer you, you been us us our during long-term and and third Thank everyone. of achievements advances

update Let with enzymatic innovative therapy an me our start on for burns. severe NexoBrid,

capacity with label to with quarter, NexoBrid use its option partial age patients reached approval FDA from limited to submissions, expanding States, to in Vericel's already as European burn significant progress, thermal Japan. XX This years revenue our placing pediatric status the securing and by States, United Union cover million its existing the of made already in United than thickness approximately treatment line orders. the a only met old with which all States P&T a burns. This those Committee newborn we indications and constraints. In NexoBrid Commercial United More commercialization efforts. expectations, solidifies XX for approval thanks the full-thickness NexoBrid initial have XX and continues dedicated approval are in to of for has centers groups in deep NexoBrid substantial make bringing milestone on

next be States increase in XX% year. AMA also received recently an care of on X and X into effect website, NexoBrid, expanding burn the scheduled its code, in market. United NexoBrid go January CPT Vericel posted to impressive is a Additionally, III impact revenue the reflecting quarter-over-quarter July which Category has reported

building the European and role of Union NexoBrid preparedness crucial in on strengthen strategic NexoBrid initiatives precedent and in its essential guidelines. This burn World We reinforces emergency share excited United designated treatment standard set care develop Health an debridement are enzymatic for the by mass States. successful in in to as the burn also recommendation incidence for casualty WHO, recently that Organization, global BARDA to ongoing the stockpiling in has injuries response

revenue the expected to end also facility of we underway. The capacity As by with commissioning currently state-of-the-art availability manufacturing Commercial to facility full before, have construction compliant GMP and manufacturing output completed XXXX shared increase is our million with manufacturing we contingent operational our $XX expectations, will sixfold. strong compared of reach necessary demand company that driven exceeds for by The guidance million. NexoBrid line obtaining upon well approvals. anticipates regulatory the be to capacity. XXXX current revenue in $XX prior product in remains of

However, the pediatric revenue. FDA activities. post-approval reduces without NexoBrid need the requiring any approved additional and for the for such associated This BARDA funding indication eliminates activities

which grow, C pediatric the the for Additionally, clinical driven of U.S. conclude, meeting inclusion the scheduled for Army To for guidelines. BMCI following activities associated a and approval via FDA, from have expansion U.S. WHO of Defense. contribution the by NexoBrid demand stable FDA Vericel, NexoBrid continues U.S. formulation XXXX, Type to with postponed temperature the been Department the for in

demand GMP turn new global facility will support thematic rising EscharEx, now debridement I for growth. and chronic this sixfold will set wounds. Our to to therapy our revenue capacity advanced increase

the have study X The market. leg We venous to billion marking commence debridement forward in completed wound the with Phase planned study upcoming in ulcers, need chronic preparations by is in unmet IND major all III EscharEx of addressing an for submission set a step year-end.

of pivotal All establish the the aims a and will treatment initiate activities will This with setup potential evaluate a and leader it of and for event study efficacy host ensuring opinion compliance on key X, trial been and Phase the required have virtual as standards provide inspection, regulatory passing commercial upcoming the including transformative to readiness January XXXX. insight EscharEx study. To trial III this broader successfully EMA safety MediWound finalized, to EscharEx, the to VLUs. into for

strategies research a comprehensive perspectives target sharing market peak market to will various and analysis working experts share highlight EscharEx projected third design, refine look we During We segments alongside forward event, and party the our the anticipated objectives scale outcomes. sales. to potential patient findings this of a analysis the trial during on on settings, event. across of are impact KOL understanding parallel, the this peer discuss pricing with In expert

further receive sites collagenous EscharEx United in optimize in randomized is of and advantages. the placebo States competitive ratio This XXXX. is Cantel a weeks, for Over the groups BLA including severe safety States support will X time study up ensure collagenase, multiple as Iruxol. Velo will versus incidence This research completion and the Europe wound to debridement and efficacy instructions outcomes, advanced other Solventon key such to are daily across patients X wound designed trial to consistency we complete study EscharEx enroll submission the first standardizes X:X:X and head-to-head follow the preparing patient evaluate and made during II the randomized will possible with addition, Phase to XX-week In collaborations launch receive EscharEx, a as trial XX and to application endpoints, placebo or time establish and a study the of EscharEx one through Europe. Participants in well which endpoints United in period, PAUSE group and be product-specific the marketed and as will into will closure events our collagenous management care as Molnlycke. use. The preparation. bed complete To and to strategic while

obtained the lines patients over EUR in development in of council million European the States XX.XX time have requiring ulcers, primate years, funding X.X diabetic our X innovation the from EscharEx program million with to accelerating foot by DFU We year. also for United each advance the

and potential those treatment the amputations, to Phase are preparation bring the about that This deaths outcomes these well, DFUs substantial patient opportunity impact study for population. patients a in the progressing patients these risk for potential underserved The on and currently us excited to have to from facing II/III the funding new infections are will complications. afford we impact improving of EscharEx

Phase DFU position IND address solidify the as finalizing are we upcoming advancements for funded the leading for EscharEx, solution trial. in EscharEx unmet III stage collogenis will head-to-head the setting for comparing the of as the VLU EscharEx initiation study recently market. submission I to the So the needs chronic patients in program to critical Furthermore, the alongside the

EscharEx, both I'd and our key summarized highlight like milestones. now the significant financial progress strategic Having to with and NexoBrid

This focus and quarter, strategic care to expertise is enabling commercial wound in strategic also This advance investment million a to insights, private global greater and but momentum. plans Healthcare, funding not leader extensive only the a Molnlycke's $XX with field. provides by partnership we regulatory one led our which access secured Molnlycke critical us through

review Hani it briefly Now financials. to I'll over hand to our

Ofer. you, Thank

take quarter revenue the third XXXX. totaled million results quarter the in Revenue now XXXX third period for was to This Development me from and period same year-to-date of of for Services. financial XXXX. the by of Let the through lower decrease our $X.X driven $X.X you million compared primarily BARDA

$X.X total to the quarter total Gross compared representing QX of revenue decline XXXX. XX% XX% change in profit This million revenue for $X.X revenue or the was mix. reflects million, of in

Phase III as expenses. in pivotal up same trial. to were up the activity from EscharEx our Turning million in $X.X period R&D XXXX, operating million for year $X.X we ramp QX last clinical expenses

expenses totaled $X.X million. SG&A

Difficulty] Okay. [Technical

Moving on highlights. to financial our year-to-date

XXXX in $XX.X XXXX, revenue of months reflects contribution X For million, $X.X months driven million the up from period or for XXXX. total reached same was This the of of $XX.X first profit $X.X million of by X mentioned to from million mix in primarily X in or first XX% revenue compared earlier. the revenue Vericel. Gross first the XX% months of the revenue total changes revenue total same

R&D million from increase of a or the share influenced by in million highlights. from share-based months was same SG&A Operating driven the in XXXX, was increase year. compared XXXX. in million the for in last for by basis, largely months expenses compared to period increased $XX.X of of same $X.XX $X X $X.X million slightly loss for of year-to-date. On per non-GAAP of period up of share per X of XX% XXXX the $XX.X by the same in In period of loss of This MediWound's adjusted which $X.X a expenses, $X.X expenses a Balance million first million, remarkable costs. loss sheet or XXXX. EBITDA period revaluation terms million Florence million, of than came $X net a the was $X.X first loss of X to $X.XX loss million price months $X.X compared of Expenses first million driven share a financial in $XX.X higher XXXX. Net XXXX in same convention to the

at As equivalent of XX, financial up MediWound cash and September million million, $XX with XXXX, $XX.X a XXXX. year-end cash, position from totaling strong deposit maintained

to A liability XXXX, exercise during including X the expenditure of $XX facility. the Series successfully Ofer, manufacturing back to warrants $XX.X $X fund million received operating from financial we offering, review. million We the and concludes $X.X for settle pipe the of with our our fully through This months our of the raised Teva. period, you. capital a allocated million During scale-up first used million to

quarter approval for FDA achievements. secured indication has raised by progress significant a NexoBrid We Hani. you, key MediWound $XX the from strategic marked and strong Thank This million very in pediatric funding. been and of

finalized in population addressing we front, for the EscharEx with the foot study analytic On alters for and Phase leg accelerated unmet market a the significant plans III venous outers, needs. a

for EscharEx We advantage. a competitive of further also to up EscharEx's versus collagens validate are trial gearing head-to-head

that median value equipped Operator? meaningful deliver Additionally, NexoBrid and operator partnerships in with to the accomplishments. that, the the our completion and of strong With our resources, is capacity. We global execute of questions. the manufacturing the momentum now any commissioning forward a initiation of call year back process did and stakeholders. the and and scaling to the turn represent look well to the patients to I'll our major plans finish We milestones new believe for facility strategic

come And Josh Cowen. question first from will Instructions] the Jennings [Operator with

off, don't about could the you kick through. I was that should pretty pushback trial timing roll then you the any goal And submission. with and in early will begin? expect of -- with my see guess, the the play KOL submission when should Ofer, event design I to an to the the is any from your after. But hoping -- with have like download. ask is color IND that in Phase interactions expect III when on expect in I share appreciate action that just January IND ultimately to we we Anything approval FDA, it EscharEx, enrollment FDA? just the seems thorough your question, of can And much of that soon you the to confidence of terms that the submission

Okay.

and most companies wound all endeavor. significant interested with specific collaborating trial So over as you in why with care and the the comprehensive all [indiscernible] potential we FDA patients time were decades. is trial know, it spent cleared them is protocol the this X and with some both and discuss are the to and by in This EMA. us in have to with FDA this We EMA, able

by here expected something is We III the we also is are required overseas were you This -- clinical or before batches from Israel. EMA process trial. ship you in started Phase that

The is XX that, we expected inspection end it So the to imminently IND successfully. we had by days enrolling And this patients. passed and expect after this start year. of submission we

requirement wanted I is is that mean, II and or originated potentially will I this care about a study the the the to collagenase the our decisions.. in just a EscharEx's patients. in role head-to-head And EscharEx, this VLU ask U.S. Europe, is not by wound or Excellent. is evidence to study bodies regulatory bolster But reimbursement and this internally. just Phase the of chronic support some SANTYL that wanted box assumption in check

be support ready we as away motivation revenue are -- main X a years as and it to we possible. launch, high that is the trial this will want with from So for that executing

reason it previous of as a post did is, main first that head-to-head to real data of to study released predetermined doing the we analysis had that SANTYL. So of analysis we all, the the prior we a opposed for in have that --

to set show to want we of for versus want have and all expand we advantages the that us SANTYL. Second, we our data

going EscharEx include we are the because Europe and States. also to for our in EscharEx it United to brand in globally versus just Third, not the having want approved process we

that and head commercial So this are position for United a [indiscernible] we data another doing in start us this Europe study States. All the don't a in yet and in have reason is we launch. strengthened -- the our that give versus

is for the kind small now is such all as Phase studies from package I have As said a completing full as -- earlier, need to that study a FDA, the are but we a we of PK to there requirements III to we have conduct, the study we kinds order once and Phase this we and relevant sure drug data in that approved. the study are study have that of a human order successful, all data collecting all factor make III in

update review Got lastly, been last in sure it. NexoBrid. I Has the been just having maybe benefit wanted MediWound make terms the capacity capacity any and we earnings one since the manufacturing on question changes of that of increase more to of us And has them. if changes, the just just call digesting any initiative. and understand timing just increase there help were there

is So important a very this question.

took called by took you process. new us process, NexoBrid, the to preplanned build for X more as process than which of So manufacturing that in and now the us we facility since will some time that know was the the a started that years is It it. we did construction we in it midyear, it. And we are the We guided finish commissioning.

on make EMA. getting closer bit for why point are in call in some we on the when it call. and the this earning mentioned inspection. to need time We closer inspections that we for to to dependency basically a both FDA have This little color is we gave now The sure we getting reason is that more

question Oppenheimer. Francis from with come will next Brisebois The

on is This Dan Frank. for

to as terms Is thinking follow-up we versus a what collagenase, over Any Is of there? potential way? post-hoc showed it color designed the expectations, we -- should a the how head-to-head II Just be superiority success should SANTYL? in this in noninferiority? similar Phase

interesting an it's question. Yes,

conservative that and/or was treat with the this and previous This know predefined we because So some a see thing we can the effects to that of placebo. have What weeks we for They thing same designed X we derive an see SANTYL with to with degreatment options. all what is to is this to is the similar only is give treat one options. They course, do expect X effect -- different that expect basically a is when treat [indiscernible] much or EscharEx. The centers only to with similarly II in SANTYL The also impact. it too that we will pretty deployment we is they -- study. a not first much can should do to autolytic the Phase option is study EscharEx success. kind don't want

will pricing we So be entities. data here credibly relevant with the that can used when discussing start be more generated

any respect how more of of -- inclusion that And stockpiling? recent Could of follow-up. Or does in what WHO this what's about you one is -- to the expect accelerate lines any just impact addition you the time -- talk with you have this the mind?

currently us. When working, we're order a essential treatment have I box NexoBrid X will incidents BARDA. be you HERA, injuries EU European think, significant for the debridement enough of in stockpiles We all that last and was in thinking will are a countries. discuss or now limitation HERA in So the European kind in for we that closer we as for mass It to is kind beyond stockpile years have that is to with XXXX, are event pass, But an check concluding an that. us. of with sign don't include that then European we big be manufacturing -- of achieved all to countries emergencies. are We it to NexoBrid able believe burn agreements you when to needed achievement an event casualty about with Europe getting In under we a believe shortage. have to to Order EU be to animate which for to to now We burn stockpiling ship the the

HC question Wainwright. PAUSE The RK with will next come from

code. were talking in your about opening comments, So CPT you X category

needs benefit anticipate from up category? And what to the this? be that so So move we can done how do you getting

have will to any I Again, the next U.S. short the I of impact don't penetration think direct -- it the to market. think in term,

it's codes it NexoBrid centers burn burns better treatment, to motivation and acquire itself. money to saves the I regardless of has because think the a hospitals, specific

don't new a So impact will will in I this But real that happen breakthrough the it the to And gathered. see let's XX It's technology a few that is think months. the impact. have -- the be should next process. XX in

that received be start study And to Phase DFU that from what regarding with DFU? can II money you're you study there about thinking in the European we the the to anticipating then before done start anticipation the authorities, needs

between we ulcers. of [indiscernible] we foot although amount data the the that is quite on on have significant to [indiscernible] So ulcers, didn't diabetic this weeks. have success less the XX% than III effectiveness have to deriving advantage the indication about of results data have But supports We see for we XX% that after EscharEx same indication. immediate this We any data X and Phase other. see we less an

and do should protocol the treatment the make opinion will we scheme aligned we is clearance in States and FDA get that write this with not how what and necessity to and and So need in it. United of to believe that are We a EMA, the in leaders program Europe all take sure to the the year. and This this estimated EscharEx key best the indication. from is process we

And done start regarding is me you're What the what you you to be study that Type had that? the temperature of FDA NexoBrid. because stable for from you're have meeting XXXX. C saying to Okay. in about going question formulation the needs learned then last And the the with

So done just between what to trying and to understand now I'm then? needs be

main have we program. X in So this mainly, activities

Phase a specific manufacture facility us enable materials to are to III we building clinical will one, this trial. first that The PAUSE

this be thing. in the building constructed XXXX. This It should facility. next and first year are We is operational

working develop of don't for NexoBrid CMC stable The kinds sure development is We that a of asked zero. close NexoBrid drag for us to a second make the very nonclinical the in meet to in minimum thing, trial. to want from all a order data clinical us to order temperature formulation on and FDA

we to similar, clinical to the to enable are we So those this the XXXX. trials products will need process start prove estimate and agency that very in that us

Group. Michael will come with from question Okunewitch next Maxim Your

approved? what RK's trial? a you Do sense the a stable on of expect I will to is relatively single, formulation there. work guess clinical follow-up be temperature needed just to small have be Do that you just question going a get

We our FDA, is and program This with agency, -- expectations. shared shared the responses. negative the the with get we this didn't

at are expect, a that we and So as will it I is yes, this they finish CMC we And assuming said, the least the that estimate to go able request year. we have. what nonclinical up

given right. stable Europe opportunity? for opportunity All the given line little has then time size you something the of the just stockpiling. potential a is looking lies, to formulation that that bit do with talk to the that sense advantages for over make where could And about stockpiling? Can this in the temperature And then

a discussing So are interesting lot. an we this is internally it question quite since

get product temperature being years. Currently, we FDA clarity -- is formulation to we disclose the that by because So be as the low have market, a of need room in to is stockpiling, of the And size stockpiling. study it the the it the divide in market. developed dollars didn't -- the potential we course, for have X millions small After is are -- of should after the we tens in of from of the only you life it this what this amount order approved. to need, we but X U.S. in clarity of the short of NexoBrid the

that are now ask will not to with having will is we authority, similar there European We yet. The and EU we is the analyzing are go HERA discussions for the called pathway. BARDA, European quantities. we which But regulatory are we --

I we matured then start will this be the in And capacity will able to shipping believe to XXXX. needs. And any the exactly not Europe. have we defining are end products towards will We when only of constraints, be XXXX,

quick then All me. question just for more right. And one clarification

solvent role What is right? in the for playing? that Looking same is it VLUs?. III at Phase the the as Is head-to-head study,

. Barry, this into do jump maybe, So to you question? want

Sure.

possible, and in the between that arms study. Compression of our in validated the the the primary is gold ensure the ulcers, and agreements these minimized Phase much as were component an it's in all securing III in for is collaboration all to provide to goals leg for standard and patients variability clinical Our of therapy guidelines the venous study head-to-head in as indication. management essential this practice best-in-class products for the studies

specifically, on the Association presented Management study benefits advances Wound and recent were Care Wound at confirmed of evidence in the Kovan at European Conference past solvent the this a both retrospective Regarding real-world CovanXLight year. superior X in symposium and

the prominent will the teams the this product that them in Given the patients as they're well, Phase Zaventem position providing the supplying study of we're to market, in quite III along appropriately. them use with for be pleased with as doing the required in their investigators and training

This conference like turn over concludes session. any our Mr. remarks. ahead. to to question-and-answer go I would the for back Please closing Ofer

dialogue everyone, So to We you, look our the next progress and call. forward updating joining our today. for during thank continuing quarterly on you us

for Thank The attending concluded. today's has now presentation. conference you

now may You disconnect.