MDWD - Earnings call transcript Q4 2023

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Operator

Good day, and welcome to MediWound's Fourth Quarter and Full Year 2023 Earnings Call. Today's conference is being recorded. [Operator Instructions].

At this time, I would like to turn the conference over to [ Gaia Shamis ] of LifeSci Advisors. ahead. go Please

Gaia Vasiliver-Shamis

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

the You may access release on investors website the tab. company that under

are Chief and Strategy With Chief of Luxenburg, Executive Corporate MediWound; of us today Officer; Vice and President Officer Hani Financial Barry Ofer Gonen, Wolfenson, Executive Development.

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

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

reflected upon are many forward-looking to results forecasts no expectation result in of and outcomes and information, impact and those as Although factors such reasonable a subject actual differ the events based MediWound. of control to update risks could of forward-looking whether due any otherwise. are uncertainties believes or to statements the supplement assumptions, from future obligation company company statements materially the assumes new beyond The that or

anticipated those written and The statements. the forward-looking materially MediWound. conference the the prohibited press note report forth to release directed in differ or cause SEC could recording factors any MediWound, in rebroadcast actual with Participants property are of as is for risk set the in to forth as of from is results the filed cautionary consent well without annual today's set call MediWound's factors expressly that

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

Ofer Gonen

Conference Welcome morning, good to Year and Fourth and Full MediWound's Gaia, you, Call. Quarter everyone. Thank XXXX

Strategy Financial Corporate are today our Joining of our Wolfenson, me Luxenburg, Executive Development. Vice President Officer; and and Chief Barry Hani

for the our discussion will highlights, financial call of results the business questions. open and we Following

excited a to year. remarkable had I'm we share that

substantial our III operational targets billion with excellence strategy Furthermore, executing a making initiating which of EscharEx, Our market. $XX million. of of are has our we Phase to NexoBrid, revenue trial commercial $X towards unwavering yielded our a coupled product commitment progress significant

Utilizing II leader as EscharEx over NexoBrid, pharmaceutical Phase market in the superiority proven same current studies. the has active ingredient demonstrated

discussion United in milestones of we have primarily an revenue, on exciting was the XXXX. its NexoBrid on It number with States, NexoBrid begin India. which and in Let's generated commercial with Japan major year million $XX achieved driven in a fronts. the availability by had

the as for for benefit United Additionally, ongoing funding use and in by well. and production for pediatric NexoBrid activities. development it preparedness exceeds review NexoBrid currently The Europe demand approval use continues Moreover, currently emergency supporting both received our in FDA pediatric and to States, capabilities. the under is research favorable from

which by scaling This enabling enhance expansion is facility, NexoBrid. sixfold, for increasing GMP-compliant, actively We to demand capacity achieving fulfill are production full state-of-the-art mid-XXXX. will schedule us our the capabilities global our completion for up anticipate We on in XXXX. production

centers our their committee partner approvals the introduced XXXX, approvals. orders. in supporting on by gained XX nearly is centers placed out of end centers quarter. Vericel at strong the committee NexoBrid product for Vericel, XX the P&T detail. further over more packages submitted of growth each NexoBrid end discuss U.S. initial which than for third P&T burn was by let's Now of a to the to the foundation and At XX committees, drivers of market building NexoBrid focused

care NexoBrid removal severe surgeons the feedback is regarding the Most in patients burns. standard with change potential strong for from with eschar have burn clinical outcomes the and NexoBrid of treated a initial This of been extremely the notably, positive. indicator patients to

effective further in NexoBrid generated demand in and India code As in and partnership a This for has became Pharmaceuticals successfully NexoBrid, X Kaken launches as major through granted also transitional Both Japan, and our payment CMS January with markets, NexoBrid. for J have through XXXX. permanent BSV. access, status. have commercial planned progressing launched pass-through been

we collaboration burns with a our standard expanded treating war Luxembourg. PolyMedics, NexoBrid in facilitate and commercial the during Belgium, scenarios The as potential Germany, further activity emergency was of by Austria, which the Israel. in Europe, NexoBrid transformative In of Netherlands establishing greater will highlighted of usage severe new in

for sectors. to meet saving we NexoBrid This in October, mass paved non-U.S. governments Last emergencies. interest future military incidents. and sparked our across has from development entire demand civilian global successful treating burn various increased casualty the allocated inventory stockpiling instrumental for lives NexoBrid critical NexoBrid both in

Our the partnership with solid. remains U.S. government

battlefield. the We U.S. $XX innovation manufacture from is and grant for on treatment U.S. the million to secured at that the of traumatic as nonsurgical develop to room for Army R&D a NexoBrid This Department is for burns new Defense stable formulation intended a temperature. have

is received million with efforts. for the of funding BARDA. procured along R&D $XX for previously readiness, designated product emergency have an we further for extra This Additionally, expired supporting replenishment

Commission also all label include in broaden ages. NexoBrid to approval received have European We Europe to for patients

this -- market pediatric supplemental review represent NexoBrid been approximately later substantially consider of accepted that for for all a anticipated reach. decision use could by year. expand the this with a approval burn Considering has pediatric XX% those Additionally, the victims, BLA FDA patients patients

tremendous are we the we experienced. pleased have made NexoBrid and with year with the very demand global progress Overall, we have strong this

the year XXXX, order project enter we influx the million. to of of $XX allowed entire revenues for us has As

we of for ahead, the $XX XXXX. Looking and with significant revenue for million growth projection million exceeding in XX% XXXX anticipate coming years $XX revenue

like EscharEx. would discuss to I Now

be EscharEx sites on half aligned trial X:X in will randomized trial. placebo. initiating both is over with multicenter, randomized will patients enroll half second submission receive in This placebo-controlled EscharEx XXXX. that global fully either leg the to The the Phase We a ulcers. patients prospective, first anticipate and be of EMA and protocol to this with aim III XXX in venous XX the for FDA or and protocol planned the are year We we evaluating of

trial of interim co-primary wound XX% incidence have complete indication of estimated the The XX An about of XX% study our very assessment the endpoints, X after similar the on focus is The the of Phase studies scheduled closure. power. patients take completed debridement of is will the incidence trial. months statistical sample to trial to complete. and to successful The provides II design the is chosen size and the

EscharEx report results versus recently who it a over to excited the were further. And elaborate I Barry, head-to-head SANTYL. will analysis Barry? now comparative We of to hand of will

Barry Wolfenson

of enzymes current XXXXs, different EscharEx in generating collagenase of SANTYL complex our treatment wounds In to States. study, superior ointment were alongside with is needs debridement results. significance. weeks enzymatic head-to-head X debridement to targeting wounds, leading $XXX X typically for The often compelling and million X of In United the II works the demonstrated nonviable weeks. contrast, SANTYL usually sharp X and in mixture robust tissue statistical collagen Thanks, Ofer. focuses over chronic of on Phase the a and components in results achieved approved within debridement. the are EscharEx, solely of sales analysis

versus within patients complete debridement, SANTYL. incidence X the with with complete debridement achieved X% of of with weeks EscharEx XX% Starting

EscharEx time the to was for Importantly, to SANTYL the of it days debridement. study took X patients full XX the complete median while time with didn't days during achieve median estimated the treated debridement achieve

bed of covered in complete both granulation critical a healing, EscharEx the it bed which Looking debridement completely where very median includes achieved time study XX.X% the it Once quick median preparation, patients with also and a wound with achieve SANTYL. having XX.X% tissue, versus SANTYL. EscharEx, no XX treated with again, wound only it during achievement with was of at was of time the with wound only patients versus step treated to days

but statistically comparable days size, differential, was the only significance the which for significant versus two. in of favorable time to for a SANTYL, days While X.XX. wound full the complete average The sample not was profile wound a EscharEx p-value the reached XX.X XX between closure EscharEx, incidence with closure to of safety month was small

companies established collaborations research to companies care, the healing integral congresses to promising top we year, Association. the Healing the Advanced Symposium represent leading in We wound compression have are Phase categories May and XM, X at to ulcer the have in Wound EscharEx much and Phase with study space Mölnlycke garnered offerings the look These II taking sharing to wound Society, therapy, in product this dressings Wound X III this cell-based interest the Management products. Wound field European forward data the place that the and the results, support from leading MIMEDX. Thanks Care in leg advanced venous on and

launch. all execution EscharEx the and is of a potential to committed you. performing ensure the an to With is to optimal and that, activities company the focused to required and the successful clinical Ofer, back precommercial development program blockbuster diligently

Ofer Gonen

you, Barry. Thank

has U.S. in has the made summarize, NexoBrid grant of been expanded in in major continued XXXX. would from Its Europe, the progress to launch So year. indication in commitment government. United in to X pediatric pediatric States been potential population with further MediWound this later use There include has outstanding an markets. funding the

increased which manufacturing scale-up to of meet the these facility. of All are our with global have driven demand, an we track on

recognition care candidate Our wound for validation leading wound in from care is revolutionizing with drug gaining its EscharEx promising potential entities. chronic global

to now We Phase briefly in XXXX. to our the over second the Hani? III hand half the study are I'll anticipating commencing of Hani of financials. review eagerly it

Hani Luxenburg

Ofer. Thank you

due for revenue the first in the Vericel XXXX, In This quarter from milestone the a revenue million quarter payment of the $XX.X our with of is XXXX. from mainly decrease of quarter. begin BLA me year. company first million $X.X Let approval received first reported previous in decrease the to the

of in quarter Gross profit to year. in was million XXXX. The total largely $X.X compared in or attributed is the prior profit $X.X to BLA for revenue or the of XX.X% gross XX.X% quarter decrease approval first payment Vericel from revenue million milestone the the of total

first to The EscharEx of expenses II million, a is Turning the study million decrease quarter amounted completion due and our $X.X expenses. $X.X from the in development XXXX. to primarily to company's reduction in the This XXXX. Phase research of operating

less net million adjustment Selling, per previous per $X loss general quarter was was of million or $X.X year. The is revaluation The quarter in million the a reported decrease favorable loss of a $X.X of operating due in in million from $X.X a to $X.XX loss and $X.X an which quarter the of net of net year. first at to the million, share administrative the the in This million at expenses previous the of quarter were $X.XX the slightly loss the or mainly reported XXXX. from first improvement $X.X is same operating share, of than profit warrants. compared

revaluation quarter in XXXX. of the profit of quarter a the to million for EBITDA million This a adjusted the non-GAAP of results was shift $X.X primarily compared first of $X.X warrants. The from loss the

full Now the let's discuss financial year highlights. XXXX

For approval primarily is decrease the to company's the ended revenue December This the XX, the million, once totaled year year due milestone million year. the ended again BLA $XX.X for XXXX, $XX.X decrease a from previous payment Vericel in from XXXX.

profit total in XXXX. for revenue, XX.X% in or percentage Gross year million the $XX.X XX.X% from profit The prior of the in or absence significant gross year. a onetime decrease $X.X total of reflects million was received decrease the of revenue payment

development study administrative to for year the Phase compared general for million in from December million or million our in $X.X million reflects increased to year year loss and XX, the II for and This loss million share $X.X decrease the were from year. $XX.X the or loss $XX.X Research expenses $XX.X compared $XX.X year. of $X.X previous previous for operating previous $XX.X per Selling, completion million in in was net slightly year million, to $X.XX the of per decrease net the XXXX. year $X.XX the expenses a a The loss an The was for ended year. XXXX. EscharEx share million

million showed loss $XX.X EBITDA to million compared previous a a non-GAAP $X.X the of adjusted reported The loss in year. of

the cash, in from company of year, Regarding successfully reported public the company fund In a at the increase Throughout the of raised XX, utilized of its cash $XX.X quarter through $XX.X our million, restricted balance to the offering. million end sheet, first as and XXXX, $XX.X an December XXXX, $XX.X activity. XXXX. million the million stood company's investments

cash reserves to With the current support company's sufficient financial operations through believe standing, the are profitability. we

the Ofer? I to that, will back the turn With and financial concluded Ofer. have review call

Ofer Gonen

growth. quarter Thank XXXX past conclude, achieved XXXX and milestones our the are in and future you, confident overall, To we the Hani. company about in significant and

orders We thereby continue to prioritize increasing to meet future our for both fulfill than XX%. NexoBrid and capabilities the grow and revenue manufacturing by rising demand our greater and current

over this results potential market. superior in product demonstrated the dominant has $X EscharEx over billion

Phase the the delighted collaborations are companies of with X top initiating study. trial look the have care with wound we we As this to III XXXX, forward in supporting us second research half to

the excited redefining the as us future about care NexoBrid to with committed and EscharEx. what standard I'm we for holds stay of

like would for I your Now call to Operator? open questions. the

Operator

The Josh TD with from Instructions] comes question Cowen. [Operator Jennings first

Joshua Jennings

that Congratulations and the partner X markets hoping demand on just quantification give on capacity But just kind was seeing incremental million in we're high any increased be in like guide also NexoBrid. would the and to U.S. the multiple -- the $XX XXXX, But limiting. assuming it some X-part currently? XXXX is all but in way here target. are the increased you're $XX demand are and question I or and international there NexoBrid $XX versus ] of between demand that first, -- Ofer, million progress details of to 'XX then demand which increased any NexoBrid capacity globally, without way [ -- for for the quantify that for seems revenue million surging constraints constraints just somewhere is the

Ofer Gonen

fill the demand is very our that as the planned. as XX% continues that see growth than Josh, have can you, just guidance our already manufacture. XXXX, will first are actually that got the in address conservative. manufacture. expectations orders question. limited XXXX, demand, to have actually that week more capacity for we we that And assuming we and Thank binding is only We your currently, of repeat -- that, that I by ability something this we threefold In To

hope long your we question. and demands those scale repeat can construction in I our XXXX facility as guidance, completing by in having sometime we it of the in I So as full the XXXX, accordingly. answered meet And

Joshua Jennings

full one Yes. also are about Phase then here just just getting Maybe deliver EscharEx, on on full half. kicks terms the second of the steps being III sign And required manufacturing study the the the follow-up just before final off And side on that help to EscharEx. for study? there any in us it -- where as able in there are are you for product off think

Ofer Gonen

So that's question. very good a

fact half -- NexoBrid. United India, the have started States, start to manufacturing So we cetera. the trial reason Japan, be the focused in to the that XXXX primarily in due And able the of is we that Europe, et from we demand to second meet order we on that

EscharEx. submit making initiating then that sure start before The manufacturing then enough we doing we last and are recruiting do thing need to the protocols aligned can Actually, with to as XX that we're EMA the and for FDA speak. trial it patients. of batches that are stability, wait we is the already we both And we need days

for -- see first we don't any the is this so So clinical the problems. manufacturing,

successfully as we in supporting X of We millions X EscharEx, don't dollars are situation are the the we once now of of launch want for ready to same We launch. NexoBrid. commercial in demand getting multi-hundreds to be years be first that piece. to is in want a or EscharEx approved, the of able in position We the are a

Operator

comes François next Oppenheimer. from The Brisebois with question

FranÃ§ois Brisebois

readout? it's in to EscharEx Just us the the when half. of be of the us here of and on interim expect Can realistic design, remind timing terms trial us on the you the based the remind for you maybe can it start in timing the if second

Ofer Gonen

the question, for you thank So Francois.

would X:X assessment. XXX the So XX% versus we to something after participants the study XX the interim And will expect the after that of I completed be recruit after have trial, like have trial, we EscharEx patients randomized initiates. need that an those recruitment. months placebo

FranÃ§ois Brisebois

we terms metrics numbers, bit the talked centers, us Vericel many help of XX the and just understand maybe and the for centers you of And there about XX, little Vericel then do -- there. a Great. in are how centers can you Okay. total stand? where

Ofer Gonen

So the for again, responsible U.S. Vericel is market.

burn And it's approval better relevant. that centers will will But that adults. population, around there I question. them to the there once for we the you XXX ask of with that be are that XX additional treat So centers pediatric get share be what can patients

already engagement, around got them year, XX in approved. already approached the centers. States, the of were all, all United XX. that of already So by last XXX in They they end committee Vericel reported XX

think job very I a So we doing that. they are good -- have that with

FranÃ§ois Brisebois

talked lastly, shelf terms Okay. you change expire? expiration and quickly, it can And product just in your life, expiration. about to the for How obviously, of demand long on the does depending take

Ofer Gonen

X expiration a NexoBrid I'm ship, commercial, going for is It's the years any stockpiling to significant. that NexoBrid can as of the years. The used, X every Everything of vial you expect and about for demand is But currently imagine, be such fact is everything use following we We even to is shipped not X to used shelf life due commercial is the being months. speaking months. that a that few in NexoBrid product. don't customer of almost

at this bothers is So that stage not us. something expiration

Operator

The next comes from with Wainwright. H.C. question RK

Swayampakula Ramakanth

I on So NexoBrid. have also on I'm question a capacity sorry,

think for to projections some through there trying 'XX. the put of and out Just you 'XX

to $XX the going be you that your 'XX to million, are what far Are handle into projection there out the these all and all with is able of end U.S., taking you consideration will the you're territories, growth whether point, So there? pediatric that including you projected this taking in it the governments? demand India, Japan, from at approval is and also or

Ofer Gonen

we question. growth on good -- million, of didn't Well, at it's a when took a very looked we demand. plan significant conservatively We the $XX

the are current demand. looking at We

are specific in. We are looking markets we that already at the on performance

market. the their Japan, can instance, quarter our them to in substantially was of increase shipments For one quite we in that expectation being after

was So the accepted well. product there extremely

and XXXX, this our that all to more only surprises. the as do surprises, million know in we $XX the currently based to we support now. that facility can be meet we It's have not ability than for unexpected $XX specific have will kind positive XXXX, growth If all revenue. include million, demand of So able we in on

So with scenario of we unexpected okay growth. are

Swayampakula Ramakanth

Fantastic. in to X different the Barry going And then there's conferences May. on -- was in EscharEx side, presented saying, terms be data in of

understand, any from will how you XX figure in the can probably we in months in pivotal XXX which help start It's -- would more in Just patients study of program. of want to what updates us these out probably be the as I to data, 'XX think? if which expect some there the will study, see kind said, conferences, the

Ofer Gonen

elaborate bit that. little a me Let on

the can data of chronic EscharEx versus agents is So There wounds. have. as interest the you a and become to they SANTYL lot for treatment all industry the figure out of specific -- position around that we this of market this strength in extremely of enzymatic were leader EscharEx robust, data the in

But all, the want FDA, is on focused of remind performance to placebo. EscharEx you the FDA I versus the

but trial, more III placebo. lot in a will we about we European Management not Advanced Symposium which is data, present of our So is at regarding will Phase Society, Association, going and at Wound it be succeeding the you and probability additional Wound strategic interest to color the of Care it easier because our versus of issue give Healing what there supposed the are is Wound at to

Operator

Maxim The Group. Okunewitch next question comes with from Michael

Michael Okunewitch

for to have nature the as a the with you feature a market? patients the market? outsized Or I utilization of is wanted is of where Congratulations similar on first I all just the pediatric in European you with progress. the to is there see Europe pediatric pediatric that burns due acceptance here ask sBLA, the unique U.S. of the the thesis thing guess could

Ofer Gonen

We understand outcome broadened we our quarter, I and financial will It it approval limitation in of ages. got of label is capacity. impact immediate hope the all last -- the it for and the NexoBrid because not now our correctly. Commission received to Europe European

it the bottom So treatment our between maybe change will but pediatric adults the and proportion of little line. impact bit, a won't

had we have different We patients. with very robust not the In European III Phase the FDA study will pediatric had. same. requirements United the We believe States, the that than expect

Again, year. proportion because of So revenue extension overall the to Therefore, to this approval as number impact the later this the the approximately is quite extensive XX% the United this in we on burn guided, -- pediatric market? should addressable population. we the significantly future XX% label increase get States expect is of population

Michael Okunewitch

in European NexoBrid because less as terms greater I immediate not was revenue. with utilization scarring, of of in the provides gentle you terms more asking is the degree more population, of said, and

Ofer Gonen

-- until that that believe how partner believe you very we it I the a if the was instead through the have associated. that market the to quite in and go United States watch, be same to it see will painful parents take painful aggressive, drug. will of ideal adopted standard care applied Europe of lot children over blood ago, in an a are is also of And topical prefer a pain this a even in being We with don't look at United his quarter swiftly. I child operation States

Michael Okunewitch

DoD All DoD to Or a could then this the to there then applicable stabilized other or foreign responders sales governments or expecting that program? the if in see me formulation? -- timeline more wanted result And first temperature-stabilized be seek color organizations might give Are utilize in also be I NGOs. on to to this for the right. formulation? any regions could you limited would And additional you're also

Ofer Gonen

question. So good very Michael, this a is

funding simplify So DoD chain to advance our as million as armies temperature. supply this administration we believe as to for cost moving from R&D for open from it gate mentioned, additional $XX the cool We can the I well in chain project. got room us

So is underway. the well project

years. all have are successful the fruits results. U.S. the or of collaborations we in our the see We next to hoping And kind of Army embracing encouraging very few

Vericel. this with that FDA to order I meeting required some course, approve of is is, here product. and agreement mention what a the to discuss of also next get product have the quarter path under guidance the to should with to development this plan license We in

it's So the with States, them. commercial or United any course, agreement any of to in implication subject activity

Operator

would be now the are turn closing all to will to management the today. for remarks. I questions these over conference time, back we taking like this At

Ofer Gonen

Thank our you, next forward joining We everyone, again us you call. for updating on look to today.

Operator

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

disconnect. now You may

MediWound (MDWD) 21 Mar 242023 Q4 Earnings call transcript