MDWD - Earnings call transcript Q2 2022

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Operator

Good day and welcome to MediWound’s Second Quarter 2022 Earnings Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Monique Kosse of LifeSci Advisors. Please go ahead.

Monique Kosse

Thank you, operator, and welcome, everyone. a ended announcing June issued the results MediWound quarter second XX, today, press financial release for Earlier XXXX.

Gonen, us You the may Chief are Financial With Boaz company’s on Officer Ofer today website under Officer. MediWound access the Investors Gur-Lavie, that and Chief Executive release of tab.

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

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

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

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

Ofer Gonen

to highlights smooth. my note discuss and of Welcome second quarter transition XXXX begin my Thank May by I quarter that we this you, proud am like how updates. new that CEO with first add of a accomplishments a conference operational call you to our our I CEO to to provide board MediWound. as would corporate member our Good call and saying I everyone. been the made becoming Monique. is from financial very and this being the morning, earnings has

This all and a across on news programs, had quarter, of is company trajectory. the strong we positive our

my our already know at Chief new would Homi his of Shamir Palash Operating led as of Imaging. Dr. Luminex Nachum of Given of companies valued Rob M&A the both Officer. begin welcome you Tzvi the as I as dollars. years Medical Mr. and like from to update, as Before transactions to Many CEO He Officer; I Chairman Mr. Snyder our Chief our and billions Board;

We to honored and outstanding notch our past industry primary have focus. to President team. the addition time us our and are Rob insights optimal the extensive of leader Care as Snyder EscharEx Board our Dr. valuable is Dr. U.S. benefiting Snyder, forward a experience. him joined to at from He Wound his is the an top look in lead becomes

who Director. wound has will MediWound development from he assume And full He XXXX, in support EscharEx. as Lior January Professor of Medical its instrumental served the for controlled as of on Advancement Management. XX past Wound Care and peer-reviewed Wound over American innovative He XXX of Board in principal and randomized President Association of the published healing as the products. of X, Rosenberg, trials journals responsibility papers continue been will of to investigator over

MediWound. experience healthcare operation execution right the makes Tzvi years of proven in industry. that, of commercial for over has in His COO him seamless notable record on Lastly, the Palash XX

enhanced clinical both We the received Phase NexoBrid were performance, successful EscharEx significantly study. forward it excellent Moving X/X preliminary of quarter alternatives. we to now for had that, X and to its our ready the maximizing team. Board leadership results trials. met On advance and in we the Phase as for our resubmission objectives was MWXXX-US top strategic we positive we set an MediWound all FDA’s MediWound BLA And our in We now of of acceptance ourselves. are

XX is EscharEx X well month, four better treatment in hosted time safe, practices, It much of we and industry commercial the care were a with standard less care. studies debridement has gel secondary Investor to program. discuss average, with all compared of the Let’s complete applications be and the complete medical On XX to current with both significance. endpoints opportunity to are EscharEx to nonsurgical EscharEx. superior debridement. to achieve Primary highlighting required in complete non-surgical applications nearly Day We time X Phase KOL Median number better leaders EscharEx the parameters. debridement, and differences. EscharEx with clinical potential than need the The days robust and a treated nonsurgical of for standard in patients blockbuster. with achieve and the These from of vehicle believe complete to are the and for statistical X is effective. to data were tolerated huge EscharEx demonstrated better is relevant Last EscharEx days achieved in standard with to potential unmet a incidence compared for of the needed patients treated is that care. debridement

EscharEx’s the of modalities. on debridement burden further Additionally, the biofilm demonstrates bacteria over other its superiority strong reduction and effect

that considered is which on not from care debridement all the effective modalities, research, standard XX% approximately but draw market conducted based results, from this debridement and most by anticipated is market share enzymatic those a comprise from third the and debridement, of of party, just currently the other market. sharp was EscharEx which that it will autolytic Our also suggests

KOL our agent patients Phase modalities, view our X choice available at our potential of about to and sales this therapy. potential is of believe are the $X of for player see from players, look for on We encourage aim market billion a from significant debridement millions advancing We announcing the optimistic to be first the Since drawing opportunity. EscharEx’s can of current strongly its event, in As from enzymatic debridement commercial webinar have the and commercial several in-depth the and we that are other we total the data, additional become share website we market. an strategic we capabilities market. continue growing options to to I interest this pleased we review which wounds. chronic you suffering

forward. all matter possibilities, are No with or evaluating are partner developing independently. We including pathway, a potential collaboration the moving we it

for will markets. will Europe We marginal. also Therefore, speed and approach for EscharEx and global States, United additional development The developing for believe our VLUs is that to DFUs. up market. both will be cost for develop the for it international We time other territories we

Phase with X next FDA second Our step this discuss half the is the to to year protocol. in meet of the

to derisked API because the have clinical believe patients will about is clarity as development to with treated which robust this data program forward. fact that We NexoBrid, design only given and we going more the commercial of once than the date, is has more product gain XX,XXX the generated but same pathway EscharEx on a that the We it successfully worldwide. say not trial regulatory

our date last our to resubmission we NexoBrid a announced of week XXXX. Moving PDUFA and filing FDA given accepted the that X, has January program,

to together, BARDA are States. with to a We partnerships we And Vericel. United have committed and strong becoming in commercial NexoBrid continue the success

at XXX enroll continue patients centers expanded access in successfully over burn patients treated U.S. with XX been to-date. who program the next burn have with leading new to NexoBrid We already

would burn field with We non-surgical care track NexoBrid armies centers their of expected collaboration States costs U.S. solution have The for administration. of growth. embrace for a our are to the of NexoBrid as the on Defense our Department with for standard to care over In all program burn Army. success and the It treatment this is open as we the and United development consistent world. Europe, gate see of the continue also seen supply for revenue simplify chain

with label XX we We of extension And of expansion. already and markets, our approval pediatric in including commercial India. expecting currently, first in NexoBrid additional XXXX. strategy anticipate continue approved in execute global countries. approvals the half larger the year, Later this we are on marketing and is to Japan the Internationally, progressing

believe Phase initial suggest achieved study complete MWXXX the be carcinoma, our target tolerated for shows with multiple to We to with pleased BCC Lastly, platform. of would have the U.S. and are that MWXXX offer of treatment we alternative ready with data study an definitely To the winner The a forward. solution of histological EscharEx a the The be strong safe, is well very for fundamentally BCC. and path moving cell our another we effective were for their completed positive to safe are basal on validation market X/X results treatment who right in This data a surgery. for for encouraging BCC. a patient-friendly is with majority patients clearance from These position. topical topical that technology patients of conclude, we with option a lesions. we

United potential very data. the with excellent We we in encouraging have approval a MWXXX partner, a pipeline States therapies of for follow-on an have commercial NexoBrid in and BCC with with initial

turn the me a for brief review Let our financials. of now over Boaz? call to Boaz

Boaz Gur-Lavie

morning, $X.X from in due quarter decrease million million and in due the million emergency the in $X.X quarter from million Total of of gel products the by the second to for were and for shortage temporary This stockpile quarter $X.X supply of decrease to was of revenue BARDA in $X.X shift $X chain of good $X.X jars. This a second resulted and everyone. primarily to Ofer, compared procurement million XXXX. in revenue XXXX. you, compared Thank second million to revenues XXXX licenses the

of driven million have profit second million was of compared XXXX. and profit share quarter some was managed compared Gross the for expect of Net quarter loss Phase a million gross XXXX. the revenues licenses. or revenue The in company’s was issue of completion loss expenses loss of Adjusted to net compared address XX% from $X.X in Operating $X.X the compared of quarter of in share to the second second million revenues million $X.XX for or or to regain a expenses third to for trials. by to was revenues to XXXX. $X million EscharEx a products compared loss in million $X.X quarter XXXX, We second of was net from million quarter U.S. XXXX. $X.X quarter EBITDA per decrease and the to XXXX. primarily this million of $X.X of per million loss in of the $X.X XX% were decrease the of the or $X.X $X.X second X net resulting of $X.X the Operating $X.XX a the of

licenses XXXX in half $XX.X for half $X.X to some million $X.X Adjusted million half million the in results. were compared year-to-date before, compared Also, shortage, a Moving XXXX million we of was in $X.X of third net of first of and $X.X for also XXXX. compared first the loss or to $X.X was million the loss $X the was half quarter by the EBITDA million operating in and of first of $X emergency the Total of Net to from shift loss million to million the share of the or supply per compared first revenue regain as million a first to by expect share XXXX. XXXX. a XXXX. loss to it $X.X of first temporary Revenues included first XXXX. of in financial to loss stockpile with stated $X.X half Operating half a million of revenues half products compared for $X.XX an for were revenue decrease XXXX chain was of This $X.X primarily $X.XX BARDA. procurement XXXX. due the per loss the million caused of

now highlights. to Moving sheet balance

temporary of As XXXX in $XX shortage for activities, $XX.X million the customers debt. revenue due investments million shift its cash MediWound quarter and $X.X $X.X delay received for which no XX, short-term operational in with of subsequently as XXXX, XXXX, in December from XX, compared had the in MediWound to quarter utilized supply in second June was chain. July and million in third collection $X.X million affected the of million by

during have million used In its the XXXX $XX the The to raised equity is company addition, be quarter updating between commissions in for used $X.X first $XX included turn Ofer? for million related to to million now XXXX. million changes management and cash quarter. cash $XX $XX revenue that, from to the impact back the to I Ofer. and shifting due the financial projected call of overview, to million my the over With concluded to I’ll

Ofer Gonen

accomplishments our quarter. very of this Thank proud you, Boaz. I’m

therapies. game-changing We significant our pipeline have of across strides made

While throughout from EscharEx NexoBrid’s We meaningful in millions to potential this treatment look the our become potential hope forward of primary $X burn step a year. community. the second best-in-class States, believe debridement throughout market it suffering a patients continued to and be approval transformative debridement wounds care capture a With we the significant the remains chronic believe the forward FDA has focus. we for wound in preference for is a of EscharEx, option billion United of sharing part to medical half States. progress I chronic the United

to the for second anticipated open include year Operator? XXXX. date results MWXXX half the X, half and the study, that, meeting X of questions. is a potential pleasure Phase call the now Our regarding it second NexoBrid, of U.S. X/X with clinical my Phase PDUFA basal With approval milestones carcinoma of this your cell for the in the EscharEx XXXX in FDA January of with

Operator

Your comes from Instructions] of Cowen. line first the from Jennings question Josh [Operator

is line Your open.

Bryan Bergin

this is for Josh. Bryan start NexoBrid. my for questions. wanted here taking Hi, you to Thank on I

Just the activity, have an pre-launch completion FDA’s broadly, year? for on the review itself, needed current context And BLA the inspections protocol two next in more or ahead you launch the can that facility the will those of expanded formal been and scheduled also be you the times? thinking next update of whether of on the the about are how perhaps provide

Ofer Gonen

for Okay. Bryan, Hi, you thank questions. those

have more already we enrolled. at the to XXX U.S. patients for said, enroll and as centers, we leading extended patients access been than continue program burn next XX So

Our to approval next access the the least of the increase plan until of NexoBrid. program expanded is size at

We for it. the with you about and we update on question. Vericel as additional This are first that, and working BARDA soon we will information as is have

As had one, for you it. the because a we discussion second interesting about just asked

that in a the As assume facilities inspection will in Israel conduct pre-approval in inspection, and we for the pre-approval both Taiwan. FDA

Israel months. we as far the for a couple few schedules next As FDA know, of inspections facility in

So we as it, be don’t think that. we will see and it an issue about

Bryan Bergin

X possible X Great, of follow-up a regarding thank you. fund program to options. should I either prior wanted extend meeting this partnerships to investors be X into the development start program also EscharEx, clear the is, with a process question the by decision that or comments expect of specific will to my for ongoing the And settled FDA and versus Phase the indication Phase is an partner. specific strategic very the of Phase independently end you could And your itself? decision X to Phase for the questions. when that I guess or on Thank And taking the looking

Ofer Gonen

Thank for that question. you

said growing players. announcing as from strategic data, since we see the I Phase potential earlier, So interest X

options. We have several

have We many approaches. inbound

We possibilities. are evaluating the all

deal to we either many we don’t We when we better decision. then much imagine, a X a in we and or can so you and will how money how will need decision, fund the can take know know prior about fourth meet trial hello? the to Bryan, quarter, like, with such a Phase looks have how As FDA are the sign required is required order this we in that. after patients

Bryan Bergin

you. Thank

Ofer Gonen

Okay.

Operator

comes Ryan question next Zimmerman from line the BTIG. from of Your

line Your is open.

Ryan Zimmerman

international color for are of they something just sounds questions. getting And for like again you chain impacted can to couple other third One, everyone shouldn’t products in fully follow-up you the taking but morning. sales? this that product Thank the the terms quarter. little resolved, connect Maybe It topics. just in this that come give the just there? supply on a the you Good more revenues us a with dynamics to of Boaz, appropriate up think is

Boaz Gur-Lavie

supply that and to question. for we which gel approximately chain with jars, Ryan. related the Thank of morning, key as This be we of the jars. you affected regained That, which $X.X temporary Last million, week, part NexoBrid gel gel. is shortage in got Good QX. in for indicated, will us most XX,XXX

next years. X.X for we enough So now the inventory had

working of we have the were orders that that So currently we it on believe and pending. resolved all replenishment

that’s already customers. and So our first continue forward overcome to support something we believe look we’ve to

Ryan Zimmerman

enough. like helpful. XX,XXX certainly sounds That’s And it’s

is talk support few study? if quarters the BARDA about to little and support for I Ofer, bit the And next question pediatric to stands you terms could BARDA of second for and revenue NexoBrid a BARDA’s about just plans continued have, think how just just where The in into ‘XX? potential over a

Ofer Gonen

[Technical Okay. It’s to, question. something good Difficulty] I’m will cannot a Thank that answer you can you. I imagine answer. allowed I as but not

Operator

reconnect The moment we line. speakers’ while one can Ofer, line you has do disconnected, just hear been me? their

Ofer Gonen

Yes.

Operator

Okay.

ahead. Let you me tell you. I Ofer, go may have

Ofer Gonen

that. don’t Okay. I Ryan, about heard I answer… know my if you am sorry

Ryan Zimmerman

love of there, to it Ofer. kind start We

Sorry.

Ofer Gonen

about sorry am I that. Okay.

as imagine, them. good strategic a supported relationship So, program for a is past. very substantially have quite it in with They considered you NexoBrid BARDA. can as the BARDA, we for

a We going few have forward. programs

about replenishment. speaking are We

pediatric extension. about speaking are We label

forward, We see that any specific have just see we many collaboration going don’t future. and plans – we in positive the with

Ryan Zimmerman

you can value of And the it things comprehensive looking ideal terms you you advanced as for potential think you about EscharEx? think terms an partner? you is guys, be we that the what about what partners a do bring then I previous back in best care But I one you of believe for are mean partner, kind pharmaceutical this wound to up Okay. terms That’s about ask helpful. or And helpful could and what striking more some then in be and from since the deal of company queue. joined following on of question And would sort in just just over have talked it terms or financial the a in consider if interest hop know it aside, you just of have for partnering in player a the company. EscharEx.

Ofer Gonen

in many transactions, M&A made collaborations Okay. an many all with agreements question. do and MediWound, pharma from kinds previous that my we made have saw companies. a the probability well. as with Thank many career, for option you In to pharmaceutical transactions, high there And big I background, something like is that as of my you that strategic here many

stage. this be approval very clear, to that are of is don’t think deals the we companies question an So, and do have to the market in let approved that you wound the and companies. partner player look cannot of space, clear, had that is as answer is long expensive. not of at I can if we companies, huge. and we that. the And for United that is considered with as reason look is have around somewhere kind the biotech pharmaceutical license And to with option a way we But biotech drug and the drugs other not yes, wound it’s the for between at America NexoBrid. to the in to your States. we Having ideal EscharEx is with collaborations care care with you all want you other number is this results did at in very to grow We looking to we license want zero significant in number indifferent see I the that the X that, two. such the is percentage not the the unique, Therefore, the a Phase of to to field that territories want find asset EscharEx make that said The North it But EscharEx. deal, in study avenues or not transaction,

Ryan Zimmerman

Thank answering helpful. the you Very for question.

Ofer Gonen

you. Thank

Operator

Francois from of next Brisebois comes Oppenheimer. the from question Your line

open. is line Your

Unidentified Analyst

This Daniel congrats and Franc. for is our Congrats Thanks CEO. to questions. on transition on taking for your the on Hi. quarter, Ofer

for is have signals as EscharEx, so like be – first-line debridement shift to complete these and the sufficient of if Firstly, is of sufficient it you EscharEx where of market options? surgical based research improvement start to biomarkers, non-surgical could option speed a the as far, with efficacy therapy are seen standard debridement these a care for it on I replacement used

Ofer Gonen

is them, saw we you claim dozens majority said EscharEx from them enzymatic is approached and and product, of which all on autolytic speaking I draw of that product the means are that very but upon or they said the which we need that not them when market. most we we aspect, all of only They or the natural, of Daniel, important modalities. anticipate market XX% did characteristics market the the not the all share currently and something touched debridement research which will the Ex, of that they XX% between definitely of think when physicians other and capabilities because the

which taking most is comprises that those market. We you the look are the speaking at effective currently getting you quite of numbers it of are something And you standard pieces numbers, about if from that like sharp debridement, huge. considered the XX% And care. see the are

analysis spoke about speaking of And $X did something we speaking are market. States. the about like a billion specific when We are United XX% only we we that market

But haven’t hope we European We analysis a suggests that information working as well. in with are question. we potential significant the about internal I on Europe speak and potential, as our is third-party. I shared answered a there the that

Unidentified Analyst

that for that? could Thanks just you discussion, there talking just if in anything I color on sharing Would color. for FDA And table Is the about could you anything debridement, more, that just one meeting, is a the something you follow-up, some sharp on expect wound Yes. were on on non-inferiority for gain is what upcoming clarity add on? closures. in added slip case to that

Ofer Gonen

can with I Yes, you something that. like share

working As you you pivotal a for imagine, program on when can are EscharEx.

as robust the robust Phase be study the X We close as are did we as did. our we same Actually, X Phase the we In to results, motivation largest will did. of very look them, saw trying Phase but all that to three the is Phase we that almost the the can it X studies. that same X trial

we had use And of complete expect EscharEx, you speak the of study can course, as know all because we close as a saw We of we kinds about the when in we – the we we need benefits are primary debridement EscharEx we So, endpoint the speaking all in endpoint speak to will with FDA, already the approved the about indications. size, X, our that approach which the other sample saw speak the to to them, when means study, design we need can which to be full incidence design, the Phase we of benefits need FDA that we that and very the about we shows. clinical about primary that disclose data endpoint. study

We are study are to hope the results hopefully, to and Phase repeat product results going helpful. those repeat we – hopefully, going the in then X it I those was will be approved.

Unidentified Analyst

Yes. Thanks quarter. congrats for the and again questions taking on our

Ofer Gonen

Thank you.

Operator

[Operator Arthur line Instructions] from next Your from Wainwright. H.C. question the comes of He

Your line is open.

Arthur He

Thank Hi everyone. just what’s remind Most I my us program. asked. Thanks the difference dosing taking touch have MWXXX of go cohort. quickly the also regimen for rationale to when and the be, And This the questions second adjusted that you clinical my the for regimen questions. the applications Could dosing would on And we been between as what’s Arthur regarding the on cohort regimen, dosing week topic for study? want the is other first RK. you. behind seven every later

Ofer Gonen

the that XXX. for definitely safe, about effective believe market We Thank for solution BCC. you patient-friendly ready for is a topical question the

some is safety efficacy issues their BCCs, you look have safety some if wounds, the quite very is burns, market, most issues, limited. you – you issues. But they not have they common. treatments available see for BCC, And If superficial at the two the that like safety look are common But in like at modality in topical treatments surgery.

BCC So, we is prove two the what those friendly that the and our tolerated, to study wanted with to well in product patient safe, is cohorts efficacious.

that the And see the we if we and second efficacy in amount we the to – are cohort. study will is going what what we cohort, higher. safety, there is did it and that the effective in second the that the to in a of do, no are to a we So, we the application publish issues is, first try as number a according saw see we that quarter. the not of we of will patients, decision cohort we the need going have solution or first be or of we next series But kind was a that took helpful. that regarding to we material if issues, take In are situation cohort the previous of be study. was a is amount it case I we as hope do results may

Arthur He

Yes. It you. is. Thank

Operator

there for further this in like the Executive I Ofer back over no remarks. are Officer, time, the At questions to queue. Chief would to call closing now turn Gonen,

Ofer Gonen

Okay.

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

Operator

This concludes today’s conference call.

disconnect. You may now

MediWound (MDWD) 10 Aug 222022 Q2 Earnings call transcript