MediWound (MDWD) 16 Aug 232023 Q2 Earnings call transcript

Good day, and welcome to MediWound Second Quarter 2023 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.

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

the You company's release that Investors under may tab. on access website the

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

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

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

expectations and to the the from are and the forward-looking in due results such based could those MediWound. to forecast many actual of Although control the statements and risks differ of outcomes believes subject company materially uncertainties reflected beyond factors upon that impact are reasonable assumptions,

that forward-looking anticipated release cause to Participants differ The as factors are as company otherwise. the factors in forth results obligation forth annual cautionary actual of no directed or a in assumes supplement to update notes statements information, events press result set whether new filed future in those today's any the well with forward-looking SEC materially for set from report to the as MediWound's risk could statements. or

consent MediWound. and MediWound rebroadcast The of prohibited of the is any recording or conference written property the call is expressly without

Executive -- take of to like call to Gonen, I'd the Officer Now over Ofer MediWound. Ofer? turn Chief

said good recorded, is so. and By call not you, way, the morning, the everyone. Monique, operator this although Thank

call. second all welcome quarter pleasure So earnings I'm It's a of you live. to the conference to

Executive the Barry of our Officer; for and Vice and open a Development. will session. prepared remarks, Hani Chief Joining Corporate call me Wolfenson, are our Luxenburg, After President Q&A today we Strategy Financial our

overview I'd recent like a begin progress. MediWound's with to of comprehensive

our our and building focused commercial strengthening on manufacturing product profitable our partnership, expanding alliances a our are strategic become a well company. foundation, and solid biopharmaceutical are new financial capabilities. to our ultimately expanding we pipeline, goals achieve We global With advancing portfolio, positioned

start important manufacturing received approval Let's this partner June are last NexoBrid. a in focused milestone, of December. to on U.S. the delivering States NexoBrid the we Vericel in update Since products achievement to Vericel commercial on detailed with We United their and for launch. XXXX. our shipped We more

time, used testing deviation However, is a third-party unable product release commercial a manufacturing associated at Vericel to during the lab for distribution due with the this process. to

a finished this completed risk incremental deviation and We risk that safety. for no have and extensive assessment determining conducted presents detailed to testing product quality patient

market the whom our NexoBrid XXXX. States as United in its and we guided Vericel remain with constructively XXXX commercial available has to of can revenues the in inventory. the will engage product partners the to there first near to in be quarter term. expected XXXX and NexoBrid, multiple the other Vericel FDA the will This concerning timing commercially that States hopeful are MediWound the in not sell United launch we affect and continue NexoBrid

NexoBrid significant we burn variation. Vericel the the on remain activities to manufacturing batches for Prelaunch of care be meantime, of in and are not delivery has next this and in the community. by batches In will process team track impacted These NexoBrid enthusiasm generated for the Vericel. interest

second sBLA XXXX. our Additionally, we half in pediatric are on for track the of the indication to submit

access NEXT for have the in burn program. XXX United strong sites sBLA BARDA $X program. awarded submission million the date $XX as into remains the support replenishment, relationship and To treated with in Our in XX this with States the enrollment additional patients across indication an patients pediatric expanded to funding of been are million additional the we our XX

Kaken Pharmaceutical The Japan, substantial Moving is eschar world. initial to market exclusive over Japanese the with notable these launched with an company is has the NexoBrid step. majority A of severe crucial patients as hold partnership undergo commercially. removal a patients X,XXX us. a and Kaken successfully receiving for In treatment burns. very pharmaceutical rest of annually

where Notably, approved Europe, and Japan is for broadly. continue EscharEx the In see first NexoBrid demand adult we is patients. adopted for more NexoBrid territory pediatric is both to it the as

awaiting second pediatric on European anticipate half a the We of Commission are also this in which decision we the indication, year. for

and have guarantees NexoBrid lease This we finalized In long-term NexoBrid the the and manufacturing upcoming a EscharEx. production sites. increasing response to demand for of the continuous products, of

current expansion to XXXX. of full in need rising a anticipate expand facility this NexoBrid. project initiated to facility also global by We accommodate manufacturing capacity of the have mid-XXXX reaching our the We completing and

to now our EscharEx Moving program.

of We leg study, Phase are venous up III the for focusing launch gearing ulcers. our on

placebo Our to trial aims between study XXX and adopt prospective, randomized carefully evaluate multicenter EscharEx's enroll methodology to treatments. who structural and rigorously a potential. The will be distributed placebo-controlled equally EscharEx patients

direct manageable EscharEx lack we are trajectory. patient a and enrollment. both Given approval feedback solidified has global the expedited confidence competition, and our about the in size of FDA Encouraging EMA study's from optimistic the

in including for CRO, selecting qualifying management the of batches course, are central all clinical the process data final are vendors, and the the We of of EscharEx the sites, manufacturing we labs. study And study.

yet for patient wound in study. fourth game-changing who point modalities. players are to another EscharEx in The enrollment has are interested partners the Furthermore, to study today largest in great the in market that fact indication by our expected to venture part the of potential of in a the interest domain, the the begin XXXX take eager promise advanced care expected this is of be in XXXX. early Phase among III are activities with been These quarter completed focal

to who would will opportunities, that Barry? like strategic yesterday. over provide call Barry, two just hand to color our made we the around more I announcements including

Ofer. Thanks,

(ph). between One running most to positive reduce in [wounds] as of possible, aspects of the study desired to, the outcome study order as achieve a important is much variability

will closure, while options various to wounds best-in-class manage goal, providing patients. them are as their and limiting still this be sites they we to for Towards the products use that the able

to After and options, best-in-class a provide reviewing also while best venous key therapy, most easy For possible. positive product ulcer are management each these could manufacturers that closure. optimal and outcomes: brands available for products, the the product are a our moisture the that to and on that drive protocol driving essential wound sights as patients categories there of dressings set compression leg importantly, we fulfillment as active and offer study, sites their three wound cell-based making product

tissue with used the is of on subjects yesterday, categories. evidence their leg respective in leaders and study to of as As these are whom two one MIMEDX announced allograft MIMEDX be are is Molnlycke, provide debrided their EPIFIX, both the placental studied in granulation and we wound most manufacturers XXX% as completely ulcers. has its venous soon category tissue. products of on strong EPIFIX widely will

use. temperature product, store to easy and room stable a is ship, it being Additionally,

will of as Molnlycke unique the management, fluid new bioburden their when of recent management be venous dressing, specifically leg ulcers. line coverage demands novel category-leading additional also as provide to will their a are handle They Mepilex Exufiber-Ag extension levels the and to well Mepilex, fluid present. high for for up designed brand Exufiber providing

each to teams. is ensuring guidelines as training provide research the only as product minimum, companies will not that benefit is to manufacturers clinical per great both of a of and also required but keeping study, the the This instructions. and also Importantly, used products their investigators for variability

We finalized are with agreement research and we coming close announced this our partner, expect the to having in collaboration third be a to weeks.

back With Ofer. it that, you, I'll to hand

Barry. you, Thank

pivotal emphasize updates to before some I regarding would concluding, like So MWXXX.

data We histologically have recently our promising study This previously removal these published out is as an our of clearances carcinoma. achieved by out that efficacy, target number trial were results XX of of being totally with The lesions. of seven I/II participants results confirmed. Phase the basal addition significant released lesion demonstrated validates total cell from Impressively, cleared. lesions clearance seven XX clinical of a to on

Furthermore, and with development confident results, MWXXX's are are safety strategic these And partnerships of patient we forming MWXXX. impressive next positive for stages about encouraging clinical profile feedback notable.

as add Milky Independent joining Assaf to six I Rubinstein with thank would Milky and leadership, years. down to us. to for I like would a he Board. Milky over our Segal much pharmaceutical record Director. brings those is after distinguished him Board biotech an as and years experience Mr. stepping like all is contributions will of our Finally, to welcome his

diligently we are remain we long-term In with our success. progressing visions, that summary, ensuring for future strategic poised

distinguished leg Concurrently, Encouraging to ready for partners up take manufacturing initiate our are business further United gear industry. in Phase capacities we the in with upcoming collaborating we position As in study the targeting expanding data development solidified EscharEx launch pride MWXXX and to NexoBrid States. our endeavors. for from are we our III ulcers, venous

in million us $XX these initiatives. balance Our execute with over robust sheet enable to cash pivotal

a over financials. brief to that of review now I said, for With hand our Hani? Hani

Ofer. you, Thank

Let me revenue. begin with our

XXXX, a revenues. profit both of XX% $X.X from the quarter year. we revenues our million last $X.X QX the Gross For same in $X.X and consistent the recorded representing at second XXXX quarter XXXX for million, slight of remain QX of million total uptick

to operating expenses. -- Now expenditure our turning to our

$X.X in expenses slightly Selling, is an in administrative for of million, attributed growth, $X.X This compensation increase the million in million, $X.X support general XXXX. QX Our future expenses expenditure. an additional R&D and along full-time increase quarter the down reported to saw the mainly from employees XXXX. to $X from to uptick the an amounted million to with QX share-based

net the turns positive for the same of per or $X.X warrants. profit shift the year. result QX of loss modest a our from revaluation on share $X.XX results of from an $X The in loss million, quarter $X.X period in Operating last loss share, million a million increase favorable demonstrated the net This the was XXXX. million quarter or of per $X.X may $X.XX operating

for million, quarter than loss million XXXX. a loss adjusted QX slightly the the EBITDA in more was of $X $X.X Our

decline our recorded up the the comparison year-to-date of half to is Revenues emergency million stockpile $X.X summed in to highlights. BARDA's during This $X.X due Moving million order XXXX. first to to XXXX. primarily in

loss The $X.X loss than the $X.X XXXX. million share the loss of period last $X.XX loss $X.XX the per of for share or million, $X $X.X loss of during Our the was from reached million loss the of XXXX first the $X.X the per first million compared half a million half was for operating from higher for or half the same first period to million Adjusted year. the quarter up in XXXX. net $X.X EBITDA

sheet Balance overview.

XX, This and of on is from a gross client amounted million. deposits As quarter to of In short-term XXXX, reported XX, from February first a XXXX year, million offering. this positive XXXX. we raised the $XX.X of $XX.X million amount the our $XX.X cash June our December

through operations The million that current our we the operations. Based on profitability. second ongoing cash to quarter fund our demonstrated $X standing, use anticipate will existing our of financial sustain

call With the I Ofer? will that, now turn to back Ofer.

you, Hani. Thank

our to market, additions industry-wide So also by practice. execution remain our encouraged and EscharEx committed to we strategic product. not redefine they to hold MWXXX promise the and NexoBrid, increasing only interest norms the of medical are in

several which is of Phase As we It anticipate more including a progress, milestones is slated for XXXX. a quarter eagerly the targets EscharEx, lucrative III of our $X clinical This we pivotal of than first milestone. niche. launch trial events, the billion

leading wound world's achieve our the results unwaving companies with advanced positive partnerships drive study. to in fortify care this Our

increasing further our Also, the the To of expansion a a to and include by supported manufacturing commercial an launch the of increasing U.S. the are This be NexoBrid expected population. by rise momentum label pediatric we revenues, markets. initiatives is NexoBrid, match to anticipate escalating primary our demand we capabilities. in by strategic or in strengthened

Our active be by by constructed facility full-scale production mid-XXXX be should track XXXX. to is state-of-the-art on and

call our for for And session. promising all joining open Operator? a you the now we journey. Thank Q&A will

We with begin The today will Josh first question-and-answer TD Instructions] Cowen. go now from ahead. [Operator Jennings question Please the session. comes

you them boxes update. just seems derisked. Hi. be fully of But taking remaining EscharEx, and call, off? need of what could the off to the next Ofer, just I progress. you like the of has and know about III Phase that start trial guys ask up of kicks to the to if couple made sure (ph) that start but thorough year. questions clear. a appreciate Good we're It maybe before the trial nearly morning. just the the on lot early enrollment, you kick [kicked] enrollment Thank make VLU listed line I I was been trial a that for wanted I hoping

Yes.

you, Thank this question. Okay. Josh, for

the complicated levels. and the past in largest the is throughout program study more the III Phase this XX all trial So VLU in It comprehensive and It's study. includes than years. a most big collaborations multiple patients very

sites, study with with For multiple kinds we PIs, two all collaborations, come. example, there of, exposed more care but to collaborations wound We are have companies. with say, only

or CROs at management. with collaborating highly agility. These kind collaborations data of price complex are comes metrics is with of complex, all the it and We

are want we the sure to hit this in that make endpoints. going So trial, we to

not are X more of million Therefore, there in months patients then year. to hitting is mistakes States endpoints. -- quickly not patients than the they are the and are in want six big, -- recruit million for VLU making we are going in -- patients number patients very don't the that United We in recruiting them $X ideal every

trial, So we all we are endpoints. execute a are the that and we and able conservative to know planning for to hit

Sorry, go that. for -- Thank And ahead.

your question. just No, I wanted I ask if to answered

MIMEDX but I'm remarks just And further now, -- appreciate potential trial? that. prominent pronunciation, you Thanks mentioned about additional III collaborations had the opportunities companies release opportunities. press Phase you've taking the outside Molnlycke Is and the trial? The that. partnership the -- of other referencing [indiscernible] Vericel in I and with collaboration your in question. actively for of there being success Yes. interest partners. to engaged going prepared the drawing similar Phase all for also, and collaborations the Or and III for are that from

So that? step can you and address Barry, in

market. the study. size have and landscape, of do A and of Phase step agent given significant But U.S. in more the debridement will strategic unique III in forward caregivers. market the enzymatic the one debridement attention would outside its We say the Yes. EscharEx advantages the with patients a competitive topical key it within of has players EscharEx competitive or I most gained the the of definitely be for of that

a significant we maximize incredible to EscharEx to unlock have are has EscharEx And approval this confident quickly shareholder committed the to value, as upon and U.S. this are in we, as company FDA. as And the by ourselves the to funding possible thrilled advance that potential launching its are value. to program

years, with concurrent every so program prepare we'll for be And over the this of III launch. several next meaningful Phase the execution taking necessary to these us step

that, will. regard where there's right We So We've report about right focus additional EscharEx, And I is to with good anything of Ofer MWXXX. now, data that's now. got if to package we're know our get a mentioned and partners research And some soon, here partners commercialization initiate make a at on on well. that development we we'll confident we'll as program point some asset. to when report and collaboration and that that progress

Excellent. Thanks again.

Please question The next comes from Francois Brisebois ahead. Oppenheimer. go with

for taking Thanks Hi. the question.

here. Just a few

necessarily fast in you enrolling, you So ideal the can patients, maybe? in not the understand help and of what too would terms if us terms you enrollment wound enrolling in just mean that not of go mentioned

wounds within studies, robust three that the successful It in have we prepares we for is for very closure saw EscharEx Phase Phase studies. II a II active. deprives wound So And days. week. those XX It a

comparison for that gel XX and XX If it's days days. a days, it one versus see I don't vehicle, know, the XX week compare you to you versus,

are gaps huge. the So

able quite are are that milestones. we confident meet to So the we

and that, we the not don't I patients that decided, suddenly And that suddenly, gel all we to closes maybe trial. results strong, said are have wound, in very don't I'll okay, recruit We a to want are the the position Having is to be a vehicle in very wound. robust, a milestones. wound chronic arm position. join the And want severe. be the that relevant the want We hitting

us enrolling will saw the and patients with -- quicker right So we that the trials are Phase the we making the that you we can gel wounds trial once in market between largest, although are gaps of numbers because and that right we finish the we is focus sure the the in best, II have approval, on vehicle -- an that we hit we we are the size saw think quite study the this amazing. that the

an inventory other mentioned kind on to even to Understood. an sell until that they your on the And why lot you. affected to Is issue, expect do And partners. that require of then why should by the that feel thing comfortable Is these in Vericel batches will to don't of next variations? potential you don't expect -- the that based will terms a work? to revenues you sell that be not of something easy if the we do? Thank then XXXX impact

Okay.

by will let next not So in start this the lab FDA. be testing by which MediWound, easiest with last me the by will be directly is manufactured question, an The that approved Taiwan. site the batches MediWound is one. tested

will be So no there issues.

batches therefore, XXX% next will fine. that So the be is there confident

in revenues we the or more we for X can two of XXXX, to NexoBrid to between demand have as times times XXXX, supply. for As X currently, threefold than

time see, the a the NexoBrid Currently, We are weeks, But keeping United order in to not in enough is with support that aside coming FDA shifting all successful resolved. between launch States. customers. in issue the we're we if the

We are to it going elsewhere. sell

for about can We comfortable it. demand the very that, you and feel have

Thank you.

next with Wainwright. Please from go comes The question Swayampakula H.C. Ramakanth ahead.

decent taken on the discussions? you. your A -- does if to probability FDA you you you where from -- questions theirs Hani. those be of get prepared you What remarks, me. discussions would these Vericel that the afternoon, and where And batch. of could are Thank couple current some think Good with through quick current concerns of the do do of stated [indiscernible] there's care see in batch? a FDA In with that Ofer

Okay.

product are. discussions NexoBrid. been what regarding constructively FDA announced and I disclose Vericel The more only cannot available course, in details, the constructively near is them. the that concerning still are of have MediWound it hopeful thing say with agency very announcement engaged an that so than term. but that, that since the confidently will recent I disclose commercially the we Other cannot So I the the deviation, remain be engaged But we with can we

in in of think becoming top commercialization would start that there over Japan line? through how your partner, going? commercialization when your And -- that. for Thank to is you you the do meaningful And terms then what

are So, to we Japan, Francois we believe to at orders to. we top wanted XXXX could line. our will look I for be all significant, the you inventory as said they if before, from if meaningful Kaken our sell Again, quite

So let's just see how they They delivered. launched.

XXXX, significant. in quite up XXXX. We lined are numbers have for orders And and XXXX the

Very good. the not capacity would you're to EscharEx, capacity NexoBrid, a get study expansion planning XXXX, And started this to commercialization then sufficient successful that of in in terms III EscharEx. you Phase going to of be also manufacturing have but only manufacture once and

about So all good it's a that the Well time. deliberating question.

So will than demand in earlier, produce. we we least manufacturing The United is more Japan. threefold facility the This as I capacity current have launched we have the new said and the at before times going in now time States and -- we but to facility to two can launched of we more expect, manufacture X we might for have launch, build NexoBrid’s as that. than the as revenues some guess for need need I to we now. to another If EscharEx if we before be is significant

in for XXXX, before you get trial. partner still could sign the them Or up started go to you. trial? you third on ahead partner initiate EscharEx. from sign trial me up need the last early terms then if third having started? material VLU Do you this doesn't from get the having to Thank in on two even and for partnerships one of also question your And Congratulations

are between theoretical agreement weeks. because -- advanced players. a was see I in, question for And components don't there prominent before a very wound crucial most three, largest say we another all risk I there. said On there few plans, coming the I as competition sign care very just and jumps in backup it's the trial. Barry we big the that are we the that see have few Barry? but will a earlier, three So will a don't

collaboration. no the whether But regardless to we way have could that. in question no, provide product way of the to our the -- Ofer a linked of our we in If initiation linked not to directly, we of is certainly the will the study as start answer we the own, securing the wanted do just To that, collaboration. buy own and education Yes. that or study no on said, is on

the Okay. Thank for questions. you taking

you. Thank

Please The with go next from question comes Michael Okunewitch ahead. Group. Maxim

guys. Thank taking much progress you quarter. on question. Congrats so my the this Hi, for

Thank you.

particular, Or of like any guess nature to about does the confined I up on collaborations. could talk there benefits the to products? collaborations I'd to additional commercial these and in off, Does trial to a it the III benefit then, bit that study the follow kick this for Phase with are and/or leading consistency? costs? little Phase is -- these offset marketing you largely III, And the collabs

will So you jump and Barry, maybe in, add. I

Sure.

no any Let's go study. are the of the marketing collaborations current is -- have these are as answer There if future III part potential we upon Phase no. The is, in uniformly that collaborations within EscharEx, question reverse. to the agreed to rights

to reduce for products the of that, Our importantly, is training have from helps manufacturers. we the we'll get it study, and the the the more but each categories our cash best directly benefit in expense

really when the running in training MediWound minimize and training inconsistency manufacturers, that our related use everything helpful. of direct to and any the We be to we're protocol which CRO it the they'll study. get products, But trying provide any will much comes will from to of as with variability the the the as as again, specifically, or

add, the may of are billions standard because this treatment going this venture, believe the scheme -- a part dollars. this the a -- the for I And industry are promise that many care naturally, great to everyone study. for years for forward. propose treatment of to largest part us, wants it players this about speaking take eager in of set great that scheme is shows success If it's in trial We it's to a fact of we the be today in

of them they study. because wanted are this yes, the all we promise no, identify to rights. But not So of participate granting

more talk are Yes. That about how follow-up. bit I guess just questions. launch, It's my one addresses Thank India little a housekeeping question. the you you. going? of a with kind Can that's Then where you

We quarter seven a something like us we an communicated that approval. Yes. process years. got Indian last that It's took

a first already we got hope that have the We of across orders. there started physicians strong We training partner India.

we are the to products expected to said well. India ship launch is weeks. started the India as -- We official Having next few in that, in

right. Thank much. All you very

you. Thank

comes The Please Weber next question ahead. with from Capital. go Harold Aegis

afternoon. hear Hello. I'm morning, Yes. further Good some just curious good to stuff you had announced.

XX in You world forward? around approvals is that had over the and Europe, going how

Hi, -- good you. it's a question. It's how are again, very

around headache have in It's quite regulatory a We XX approvals the world. our for MediWound. department

As prioritize, Europe. countries current earlier, means in to We for are we on focusing the big I facility. manufacturing too five is only decided that big said the our which demand

focusing We the United States. and on Japan are on

engage We with FDA. are the I still, said, as

bit As a a for let of territory little -- is that know them countries, the smaller certain we each magnitude, certain unless different. with we get order

for year at ship they not the stage, We least and can NexoBrid. until another going them get wait need are to at this will to they

be Are thinking some that supply ramp-up? able the to now interim and might in alternative new you Okay. create you about the facility between

it of are But know-how. to MediWound requirements, we is It validation kind not the all have that that construction unfortunately, MediWound's then manufacturing marketing. something to XXXX. you can -- No can regulatory in going year, a a It's complicated. in only a is and invest middle do facility. the means of the in finish So This manufacturing stability, facility of world of and need one standard we we manufacturing very don't it's drug. at not without botanical all It's a process. some

can capped XXXX. educating demand. in is are the years. in most all demand after XXXX we at of Currently, demand that the the it looking Hopefully, the market if that needed. we creating and we and we the coming for have are XXXX, Unfortunately, We supply as are

Thank you.

you. Thank

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

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