MediWound (MDWD) 17 Mar 222021 Q4 Earnings call transcript

Good day and thank you for standing by. Welcome to MediWound Fourth Quarter and Year End 2021 Conference Call. [Operator Instructions] I would now like to hand the conference over to Monique Kosse with LifeSci Advisors. Please go ahead.

Thank you, operator and good morning everyone. a and announcing XXXX. year issued the results MediWound quarter fourth ended today, press financial release for Earlier December XX,

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

we the prepared call Following Q&A. remarks, management’s for will open

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

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

MediWound. Executive over turn Chief Malka, Sharon? I’d call the Officer to to Now, Sharon like of

financial Good our quarter our and morning our call Thank operational to year listeners our afternoon good highlights. in you, to and end discuss fourth Israel. and conference Welcome listeners XXXX to U.S. Monique. to

to up be execute January, EscharEx, high line of we The as a in with a its in throughout the Phase approach endpoint across we or XXXX, operating a milestones transformational X several with showing XXXX top for demonstrated the of all a business of We care Starting with continue the complete EscharEx high primary p-value met areas same XX% statistical important XX%. study year of Vehicle, arm, Vehicle. our degree with during treated announced measurement significance, well to setting year. EscharEx U.S. study. the Gel patients autolytic from debridement data either a versus standard XX% EscharEx The compared modalities X.XXX. with Patients in of debridement the which enzymatic the non-surgical incidence period, the of was treated complete incidence Gel to was robust

to additional are include to as guide exploratory and This expect towards develop and patient our the next full We which follow-up be secondary heading have study will the X measurements, safety quarter. and program. from well as endpoints will dataset completion Phase used

leg ulcers, Moreover, In X lower the of following load foot and leg treatment addition from EscharEx and announced both preliminary Phase Phase data X of the ongoing demonstrated a effective debridement safe EscharEx. we also pharmacology data, positive study venous to indicated samples evaluation daily EscharEx. the the therapeutic few ulcers with and biofilm bacterial reduction a applications. within ulcers of tissue fluorescence images and an of

potential FDA meeting for half recent Care Wound the present next those an plan planned with are dataset Phase as two results end quarter trials We the the of EscharEx. at second order Scientific to for the these pivotal the advancing expect of our Conference program X in In in the soon. meantime, Phase we XXXX preparation discuss this for X in and from full We to have results the study to well. the from plan

VLUs of opportunity, commercial plan are about development We excited lastly, date shown of there has with and other we to component we has its improvement; effective are on care; following: know to wound commonly generates and option yet hundreds bring be committed for that X sales clearly debridement in the the for EscharEx clinical a non-surgical hard-to-heal market. patients DFUs that believe enzymatic critical can is based We leaving undergo hand, most to heal used room are patients show it to the of the millions every EscharEx with bringing debridement safe applications. game-changing in to EscharEx positioned wounds autolytic, several become it wound we given a weeks potentially management. conducted the wounds well every or method, suffering a of few trial debridement which million millions transforming third, year every of effect, forward is magnitude and debridement much first, EscharEx, therapy hard is to U.S. in to to and in alone; the to daily become year, a on take and debridement best-in-class potential from two

program, NexoBrid a on of XXXX. commercial we a position and and in U.S. half the launch which review a anticipate the NexoBrid process, midyear by to Moving NexoBrid resubmission first year-end track in X-month would remain for of we for BLA, potential approval

which the to of NexoBrid BARDA pediatric scientific from we product that for and robust We as efficacy expeditiously this plan a NexoBrid forward label which their extension of to $X the centers look through U.S. bringing its on across Vericel to of a to with pediatric the end, label with quarter, European through clinical standard embrace approval. we as care. pediatric the and path partner funding available contract, see Europe, Phase X clarity NexoBrid expanded gained a next BARDA and protocol continue XX million for on safety treatment its In the continue ongoing of Europe us and to providing the NexoBrid market results Commercially, with support will the To be pivotal months to resubmission will follow-up. study burn towards based expanded possible. run regulatory innovative submit We access approval extension advice. supplemental Medicines Agency BLA NexoBrid for a as

achieving consistent operations. revenue and result, profitability showing we now commercial are As have growth our NexoBrid seen in a

efforts will as we approval among commercial continue additional approvals year, anticipate Japan, continue Our others. grow marketing we worldwide. India, adding this In in marketing to

for NexoBrid. by for if simplify Department the we Lastly encouraged research of for were all the grant Army. world open Defense field development U.S. a for successful, as solution the U.S. as treatment well non-surgical NexoBrid, for research our chain for over NexoBrid This care the burn of supply could as gate armies project, the

vote our specific. yet in For another technology NexoBrid in was us, of confidence it platform, and

additional as currently $XX million with months. in least recently the our pipeline. approach Our funding rate and for liquidity at activities the XX improves of near-term the operating fund sufficient equity we offering. a planned public realize facilitate potential anticipated cash sound of we efforts our our The balance our to cash catalyst The next current balance is as is

Before their over EscharEx want our I to families, commitment our also want of financial and participants, and the I thank and clinical turn the to our study participation our call our their discuss trials. clinicians results, for Boaz to in our to shareholders Board I thank support. their details for

coming And Boaz? to our would months the to now looking for call over we a summary the like important turn financials. as I are Boaz forward We approach to several milestones. of

morning, and Sharon, good you, everyone. Thank

growth NexoBrid ex-U.S. our I’d from both First, territories in reiterate continued as new market and XXXX. to into its gain revenue the product to and U.S. operational the continues increased profitability like traction

We the funding BARDA also recent fundraising. our liquidity and the position significantly with improved on addition of

compared was by gross $X.X margin of to a and the revenues Product in for and a full of sales year with $XX.X Total the profit pediatric services XXXX the million million for resulting XX% million million margin to Total compared stockpile year quarter completion million of of Operating XX% fourth XXXX. results. now which Europe. XX% for increase quarter due and margin the year XX% period. compared procurement from fourth in quarter in $X.X the compared to quarter decrease BARDA’s Gross first reflects the gross $X.X with fourth revenues XXXX, million stockpile increase XX% in the $XX.X of for BARDA, BARDA to for $X.X were million, million were margin of of a of XXXX, $X.X revenues gross of revenues a for gross the profit in of profit of XXXX. million our primarily $XX.X for million financial driven $X.X from $X.X tech XXXX a expenses were profit Gross clinical decrease revenues gross million Moving compared emergency of $X.X an was X%. emergency compared and to of XXXX XXXX gross programs. XXXX to XXXX million, were of increased with in an of product quarter of procurement to prior the to with in $X.X for the

For the were million R&D $XX.X the one-time of quarter was full fourth million Phase expenditure G&A of driven in year. in million $XX in year, Operating million study last million. the quarter compared of of $X.X loss expenses XXXX, investment X compared primarily $X.X and $X.X by million loss EscharEx Operating to for to $X.X a

to million for For was increase Net million loss net a development to per or the loss compared of or full first million in of XXXX, to share a and million the of $XX.X research primarily loss quarter $X.X share was XXXX, $X.XX compared due XXXX. year loss $X.XX for quarter of in operating $X.X $X.X expenses. per the

a share For $X.X year compared for of for or net million quarter EBITDA share reflected full million loss compared a to Adjusted $X.XX $X.X of fourth loss a the last the or the of of $XX.X was loss to XXXX, million $X.XX $X.X loss prior per year. year million period. of per net

million adjusted year loss $X.X million a For full of $X.X EBITDA of loss in to XXXX, compared a XXXX. was of the

highlights. sheet balance our to Moving

position, activities. strengthening and of were utilized million XX in gross As the of and its fund XXXX be at The financing the cash equity short-term to expect cash to months. support operating XX, XXXX, million proceeds, next $XX sufficient an we the $XX.X operating activities anticipated and recently for company million, ongoing to it $XX completed in least December company its investments currently

Sharon? $XX be And Sharon. $XX have million For concluded XXXX, over million. With we the to expect call I the that, financial cash range yield back turn to in to we now my of overview.

Boaz. continued the year-end. pleasure of EscharEx; it is that, NexoBrid now Operator? for X call our BLA on clarity open With has Phase my resubmission year, already the This this us Phase study potential Our the Phase NexoBrid near good positively and dataset the we EscharEx announcement of several your look BLA; you, the forward year questions. in news X X including: topline EscharEx; and design started studies with approval data, for from the U.S. towards as off we milestones, for Thank of important throughout full to to

Thank Cowen. Instructions] you. question first with [Operator Our from Jennings Josh comes

Your is now open. line

Hi, I the Phase good those path on morning, EscharEx congratulations to forward ask taking question. about Sharon wanted thanks and Boaz, X here. the And results. EscharEx for

the two upcoming to be FDA meaning trial I Thanks. U.S. this should also the that then program? need year one as used of investors meeting to one study of should Phase about data have with how this the X meeting? or FDA approval? that Just – the think this, the Phase studies follow-up trial. profitability will in expect mostly pivotal potentially you scope on still files X you we do existing for FDA, the X Is And the of generated with able how the that about you’ve be know this think Phase following definitive And

Thank and question, good Josh. you your for Sure. morning,

end given probably we data, communicated for additional FDA. did quarter. meeting study to heading to study we studies to to have coming deemed are expect and that controlled premature an indications, two ongoing towards the the follow-up and And anticipate Phase the think the completion the on X enable share be data-driven out two a a tandem. to yet if with based to adequately which that on information use the But FDA. studies discuss Currently, the as studies, conduct as information. full yet I the the discussion of have based including X As safety. for Phase data ongoing the of X it’s and X the next again, fact to the full yet next reach we Phase either will will the the And And we or registration, discussion secondary be it’s on stage to the in that, course, the stage, premature us exploratory all leverage that not file in Phase results. include about of additional from as will The based share dataset completion, two before, one will will company, this we with you dataset, generate

then remind last head-to-head trial, And how debridement. if just comparison run could that. group, how roughly as non-inferior for talking – see that in for the group on for question remind of being Thanks will and just superiority the you us you many what wanted just on the Understood. EscharEx patients us questions. comparison with see sample Can X the to enzymatic non-surgical many again Phase in versus EscharEx? we we Thanks be for the sales to terms will

problem. No sure. Yes,

secondary care XX autolytic and for in of in and reported during the standard patients information care for EscharEx stands current hydrofilms arm was was of autolytic enzymatic ointment in that as we Gel The arm, period one-third with comprised XX% general, share days time-to-complete XXX of achieved know, standard SANTYL also the either the comprised non-surgical XX for SANTYL you etcetera. area wound the and, applications standard care the stands XX% study, in So the And standard of patients that non-surgical the the opposed treated probably non-surgical expect all reduction, EscharEx patients as of hydrogel, and XX is measurement debridement, same The care. in the arm. can care of standard enzymatic, and standard the of you course, arm debridement, this of was Vehicle non-surgical is achieved XX patients which of we of we forward, to the that of with non-surgical What of the application. of maximum non-surgical looking be arm. to daily granulation compared arms will endpoints, we X to in different quality of of one-third tissue number analyze knife between I care after

That’s great. Thanks, Sharon.

you. Thank

Our next Kevin comes question from Oppenheimer. DeGeeter with

now open. Your line is

want for the biofilm to the my taking and finding. I pharmacology question. Thanks great. specifically Hi, start data with

or quarter mean First regulatory in is about label think second to section, amenable off, comparative data a a do of how the terms specific where not should primarily And potential about on have second could of secondary a presented endpoint specific should in that that endpoint venue but primary in a section, be interactions – do on of XXXX, terms or the think clinical not terms we registration benefit in strategy? may here think in potential is be should with the data of but in that as there or agencies I that half capturing you necessarily the we, for in presented? data basis biofilm a – findings mind that – you secondary the pharmacology the we necessarily

for Kevin, the you, Thank question.

part incorporate believe data, the all, We I it will as up and if measure will the that the and be additional included date, of of to load, patients initial we clinical treated we of with assume Phase that So on the reported X patients to effective of and that this microbial it in to as supportive we continue the from EscharEx. can that the you we for biofilm were the replicate of the the the plan know, debridement, study to of pharmacology safety progression. for treat to program endpoint and full data be and data XX But part wound demonstrated will fluid we also X reduction in biomarkers the brand results program. Phase and top analyze dataset, considering first in the

a or maybe your just guidance, housekeeping Vericel clarify one partner, your Great. burn includes cash NexoBrid milestone from excludes question. a that on And just approval? potential Boaz, then

including we XXXX. together that next with months. be cash expected with payment and the surpass the funding recent So, the indicated, which is of BLA Vericel QX of XX from in BARDA the XXX, to milestone the will is received fundraising It

that. for Thanks Great.

Thank you.

with from the comes Our Zimmerman next of BTIG. question Ryan line

Your line is open.

for What actually fast nicely. in the U.S.? achieve about expectation to start grown NexoBrid just that that scale could and Sharon adoption grown and we Boaz. Thanks U.S. how is questions of the ask, has kind I potentially – potentially the afternoon. ramp start want should NexoBrid international when Good and to with think internationally cleared taking has and the in

Ryan you, Thank morning. and good

the U.S. the we you And as market, know, for the collaboration NexoBrid. primary NexoBrid do for do responsible the commercial market are U.S. So, is which for Vericel, the that have commercializing believe approval. we collaboration, with market upon

a data the in access coming the already more Europe, quicker achieve treated as generated we hands-on and experience now U.S., fast. given substantial will Europe, we from expanded do running to patients we than program are to such the market Europe the uptick with share standard of Given lot key enabling data NexoBrid be of from the and an where U.S. in faster and that believe compared becoming pretty fact brands and in NexoBrid, XXX positive in what this we that care in Vericel had

population factor that this to the year. second that we overall ramp-up. end, expansion plan XX% is that half for the accounting of XX% we can key fact will ex-U.S., label add revenues marketing expecting can EU while to boost and – worldwide. we more to get we we other additional growth India and have see expect markets, To out that another given mentioned growth the also approvals. XXXX as before, pediatric population, revenues international the i.e., the And this to can be of in Regarding for during pediatric in And markets, about and Japan fact approval are the more submit continue in to the marketing burn

are internationally, the in Got expansion, it. to referring U.S., you not Europe? And that pediatric label

is course, we already are the expansion start, to course, we where NexoBrid in will pediatric in next approval. based with then countries countries include the extend the U.S., And that the European also can – for already of of and adult, the follow approved with pediatric is, we indication where it Europe all will label So, file on approved.

– And the expansion in to the U.S. approval label after have BLA. for we we following receiving get also adults, of the First, for ask the approval resubmission will the

year into gross just quarter as of just you gross taking that kind specifically, and you the think to speak for what kind of margins And and this to you led Boaz, we pressure question. it. Thank the move if could margin Got about on how next year? this

Thanks Hi questions. for the Yes. Ryan.

gross XXXX had had in XX% XX%, So, the of revenues for That improvement margin which overall driven slight which was X%. we by a was from increase XXXX.

XX%. If you of revenues and know are overall portion the had higher Vericel. from margin a was from basis That you XX% XXX – drilling down for margin XX%, that it of as product to procurement, from a by revenues. and to are a gross the to we which We decreased as the royalties even impacted points paying from gross slightly BARDA composition

Looking indicated, completion into ramp as BARDA expecting up. we are to And first XXXX, the in the half. procurement rest Sharon throughout revenues ex-U.S. world, with we of the are

the So, margin at we XX%. should gross we around believe keep

Okay. Got it. Thank you. Appreciate it.

[Operator next H.C. Swayampakula Instructions] from Our comes with question Wainwright.

line open. Your is

This of Good Boaz. and quick Thank questions. couple is Sharon you. afternoon A RK.

on is EscharEx. one first The

market United said, doesn’t some do you about understand really can little the what current the the – you Just give commentary trying there us you is? in how bit to a think potential the work. As SOC on more States. Is market on

terms come I So, the of pricing? Thank do you market? in How you. growth in, understand in to could expect you am where U.S. trying just

the the given reason RK, general, commercial very that opportunity. we Thank as question. the its And is are potential, the Sure. of In magnitude excited you, follows. key for EscharEx with for

effect. debridement of the is DFUs and the wound we those about various debridement, non-surgical is of $X.X critical about every and and the of is of cost undergo with sites every EscharEx, less the at to trial which of the every Yet, weeks leg safe debridement given game-changing debridement product take And which hand, That on sales daily million a become can believe know is alone, product, for wounds are applications. big also wounds component First show a millions X to enzymatic, all the in tissue a In two we potential U.S. hundreds all from patients in ointment is used necrotic are care. enzymatic care shown debridement become of treatment the week in in suffering methods and addressable across for only take patients of be there the debridement it generates venous all, potentially well market, that the of available that that and year, autolytic why current year. enzymatic a estimated in most believe market room millions much believe of current commonly billion. And best-in-class several do in has improvement. leaving of Santyl either And current And expand ulcers to-date to cannot debridement other portion EscharEx replace enzymatic that this are EscharEx to positioned the segment. EscharEx therapy. than few hard-to-heal we but those wounds. we use effective the option those the The

for you on Then NexoBrid, and utilized commercialize distributors elsewhere. general, Europe in third-parties in your of product your Thank that. to

think plan utilizing, Japan to who or forge same new co-promote in is India, you be we you can geographies? would when with do these geographies with that about, somebody you new strategy you any that about talking So, the are these relationships and

product the market we mechanism So, and on collaborating distributor focusing a leverage in between imply the as worldwide local distributor the And and is expertise revenue to our process the we with based to NexoBrid product, – access with local as CEE and local global while local with Pacific, the with our international The LatAm, get for cost are or collaboration with his approved reimbursement strategy are commercialize distribution market then price approved. with MediWound. regulatory the we well is get Asia – product share countries GCC. Internationally, responsible the distribution.

the Israel opening restrictions, question seeing or comes on it going travel no you up FDA Thanks. is with And NexoBrid, into Okay. – last me, should in And when of country for any inspections in right we not terms you have comfortable any for with feel issues. so now? are little that Israel the time

Yes.

So, as little worldwide, I as U.S. restoration, what follows. do know this to of you at inspections that now it’s We FDA. said the point you in can But show believe eased, and Israel. occurring. And behalf travel are have speak we outside the a premature on is that do some

We are also in familiar inspection one Israel. with

So, optimistic we are looking forward.

you questions. for Thank Perfect. much all taking my very

you. Thank

Thank you.

Our with next comes Aegis Weinstein Nathan question from Capital.

Your line is open.

Thank you. in Good Any morning was about could morning, that be you Sharon Just and and the just that in my us skin could had Boaz. product? question. Thanks MWPCXXX for what I non-melanoma taking updates outlook question this one cancer. remind share?

Sure, Nathan. morning. Good

series percentage know, of provide cell preliminary you efficacy we a with be the the complete U.S. looking low-risk to of of The is study mid-year and of histological was to basal different have on by lesion And target with of published carcinoma as is measured designed the basal Phase data for cell first safety XXX case forward its study on we clinical as a this in the as as design paper. study in based X/X cohort schedules peer-reviewed by to from that evaluation treatment are us the administration of evaluate patients will clinical the So, clearance. XXXX. well carcinoma the of initiated This tolerability using

Great. Thanks so much.

in for to back further would Malka the no like questions to queue. Thank comments. closing I Sharon am over currently I the showing hand you. conference And

a to everyone call. Thank you our joining today. look you. day. on have for next you again us updating great and forward Thank you We Thank

Ladies and gentlemen, thank for your you participation.

You a may now day. wonderful have Everyone, disconnect.