MediWound (MDWD) 15 Nov 222022 Q3 Earnings call transcript

Good day, and welcome to the MediWound's Third Quarter 2022 Earnings Call. Today's conference call is being recorded. And at this time, I would like to turn the conference over to Monique Kosse of LifeSci Advisors. Please go ahead, ma'am.

Thank you, operator, and welcome, everyone. a ended announcing September issued the results MediWound quarter third 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

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

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

highlights. discuss and Welcome third XXXX Thank quarter you, conference operational call our our to to Good everyone. Monique. financial morning,

track This quarter, across we our all to positive programs. announcements on with a of be series continue

points generate several believe approaching the inflection going and revenues are approved, forward. will in meaningful significant it that significant NexoBrid growth once company. is We XXXX for We

market year. billion a us EscharEx on NexoBrid, next will with to of we launch opportunity the where presented we focus $X study Following initiate X plan to Phase

essential data, large addressable for We and a strong X all operational aligned partners, mature these a success, have elements balance markets, experienced Tier sheet. team, and pipeline, favorable

Before discuss position of through we like expected current the address support addition saw I we $XX added our combined an our for positive to were raise million benefit, for investors an we to October Registered as We capital the the this to company. was made news better validating offering. in MediWound in would success. through participation shareholders, bring we our raise of ahead for able significant new funds additional quarter, of and completed were members this in pleased XXXX. management activities offering, firm the have commitment the participated and Private sheet with of and balance us support to confidence to both demonstrating Also, who and from I our This vote Direct a we important complete Board strategy. progress, It team where now of will additional our the our

EscharEx, for will to Now and to demand NexoBrid, up scale accelerate address operation. for global progress the our our funding, we increasing able clinical the with be manufacturing support

We the both future long-term. position are strong and for a in near sentimental the

of their and Eric securing established experience Moed, They Strategic Samuel we Dr. to a Advisory industry contribute our comprised financing, addition to In and our leaders, Lantis, will insights have in Board facilities esteemed and John our providing scale Shem-Tov. highly sharing supporting operational expertise and activities life our optimize us manufacturing care, of medical of strategic all science manufacturing their up wound knowledge by and the processes. aspects innovation, will

becoming a biopharmaceutical in MediWound with into talent such company. essential advancing engaging As a CEO, I class world believe is

to Moving program. our development clinical

commercial needs update with start and opportunity. tremendous medical demonstrated have the unmet where significant we an the in EscharEx on me our Let belief

than now to a of are blockbuster. potential more We ever certain become its

Phase X incidence complete the and including non-surgical safe, effective applications that to was EscharEx time are well Our the debridement, standard debridement, to to the required, be robust. of from complete of clinical tolerated, parameters, were all et superior the key proven number studies of both results cetera. care across achieve

saw also biofilm at Advanced poster further bacteria highlighted and burden, over superiority abstracts We which in Wound of to when symposium as oral data the very the poster was were one in modalities. selected featured These two on of the one Las honored demonstrated of presentations We an presentation. be other debridement received. Care reduction were presentations EscharEx's Vegas. The results was out the well the XXX

FDA in to weeks the next X Phase the step coming to is study few the Our discuss meet with design.

the We data that once API XXXX. to We due generated on believe regulatory fact but of seen we the we program have X also the as has to product forward. used NexoBrid. we due path we commercial initiate are is in planned update robust pivotal of an meantime, first the the treat will a our patients over and Phase clarity the track our XX,XXX EscharEx only gain clinical half to-date, to study development And not prepared EscharEx NexoBrid In provide de-risked successfully same as to worldwide. that

A the EscharEx players players. We studies are is following by in market interest very care to qualities the wound continue debridement generate X competitive in from closely. agent topical demonstrated a Phase most something strategic with

are on collaborating all We of with partner evaluating our our to EscharEx own. a from developing strategic options

shareholder well-positioned believe the to are a pleased very here. have We value. with we We significant create flexibility winner to be

Turning to NexoBrid.

review and an inspection in Taiwan by was accepted X, As BLA we review in XXXX. the The facilities last Israel is progressing, underway. in our announced of of our of are BLA call, PDUFA NexoBrid the FDA's January manufacturing the FDA and date given a resubmission for

to Our in partner the XXXX. for Vericel plan launch half a continues NexoBrid potential first of actively

NexoBrid in patients at the physicians with gain access sensors The treated been our NexoBrid. XX To-date, confirm expanded States. of leading care standard to patients important the enroll United have continues an have These with patient supportive important NEXT very the firsthand experiences NexoBrid. health physician of burn Our of that and been States. practice program part and belief will become NexoBrid in of the burn XXX experience United sites

the interest about young having XX% to An population. Additionally, I'm our the NexoBrid report painful United and XX% conflict as quarter, as to can incidents recently. surgery, by The Department option traumatic allow collaboration of face Defense effective Agency casualty growing quarter burn They in track. Pediatric patients extension mass undergo in of of will the We approval debridement of that of European with the by pediatric NexoBrid and treatment pediatric and first very and remains non-surgical in is a families. label In and care This standard see NexoBrid to events without their Last be request patients in opportunity States surgery. patients fueled burn submitted have another decision in that for countries. for to burns embraced Medicines often that XXXX. preparedness solution more fast, the the anticipate total which safe, to the a painful pleased Europe development part more we is on Europe, we represent the a of have NexoBrid. sales just mass the Ukrainian-Russian skin casualty is for to occurred steadily grow. of in

endorsed believe in the that are the this opportunity, will preparedness quantify of BARDA United we the be as well. While unable to in that we Europe strategy magnitude States embraced

burn NexoBrid positive presentations. end Lastly, Today, large at settings. XX is in market Leading was look of to NexoBrid using this patient the by XX India the year. received leaders Burn Internationally, around a NexoBrid expansion. pleased and highlighted European and outcomes approved warm approval we such additional we in the experiences wide Congress meaningful Japan posters and were their thought the from Association specialists anticipate as range by and shared reception XXth in countries the of in we we world Italy. and forward in

Turning MWXXX. to

We study shown Phase the with safe BCC. the meaningful to initial tolerated of year. continue continue cell of patients topical the well-positioned conclusion, We majority results the saw this NexoBrid well the excel In States. we very to in visions. carcinoma target announcing the histological United clearance U.S. Board. the and achieving We be end clinical generate commercial study near-term. who also forward basal across from of We and will move launch our the for completed approval or X/X anticipate us to the of study. and by to patients results the in positive of are and This revenues MWXXX anticipate potential enable was in the treatment with development

to eager we our are develop We launch and EscharEx, MWXXX. pivotal therapies X a program such in Phase continue compelling pipeline, follow-on to as

updating to optimistic do to resources the MediWound's look all progress. that. have on future about very forward and I'm our We you

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

despite turbulent capital funding development XXXX, that We're commercial believe has Thank and expected EscharEx Along you, morning, good our growth, sufficient market, the in January payments and the sheet. BLA plan fundraising milestone from pleased our we $X.X which NexoBrid significantly Vericel with balance Ofer, the stressing the clinical upon million to approval everyone. program. sales we have with recent support

statement. by procurement of XXXX Gross $X the of for $X.X for compared in costs compared European quarter gross development XXXX million of were million expenses third net $X.X in financial XXXX result $X.X XXXX share-based XXXX. of This SG&A $X.X million compared quarter third for primarily or third BARDA. compared and of the a EscharEx quarter Association Congress. Total million to the our $X.X from $X.X the for of $X.X as in and of stockpile research revenues, million. profit the $X.X million. expenses emergency or Burn for to the the million, one-time products of XXXX of million million period. market to compensation million loss for million. quarter the $X.X expenses was The quarter activities million of XX% million third quarter prior in Research revenues was $X.X compared related increase primarily $X.X was third a was net Operating were the to of million, the to Revenues to approximately revenues. third XX% result Moving quarter were of $X.X of were $X.X third a decrease same profit marketing to of XXXX

million third This dictated $X.X million related $X.X to XXXX. our regulation, U.S. million $X.XX. to allocation quarter The per a a to non-cash compared the per is has quarter million, or loss from net loss of than loss in Our million $X.X fundraising. $X.X increase which primarily $X.X per share, our loss million. expenses $X.X the a net which $X.XX to in $X.XX compared affected different of of This GAAP. were financial posted nature, for due XXXX The Adjusted to warrants share IFRS the was of of are of the million, resulting recent was by third by of XXXX a quarter EBITDA third company share. compared allocation loss or expenses, is for $X.X

was Moving first the decrease to per $XX.X $X.X a of of of million nine now the months $X.X to million. Total of year-to-date XXXX nine $X.XX million financial This $X.X products of million nine $XX.X a of net Net $XX.X loss were from in stockpile result emergency EBITDA months loss XXXX. the first an million. months XXXX operating compared compared the million, to $X.X was first of $XX.X XXXX loss of million, a $X.XX $X.X by for million. XXXX months compared in results. compared loss for of to to nine million months of Revenues or compared nine per BARDA. of for were XXXX the share first Operating loss or the for $X.X a procurement primarily share. Adjusted was to months million in the nine million, XXXX loss $X.X revenues of first was first

to Moving sheet balance the highlights.

its September range $X.X third of XX, $XX to with December $XX.X the XXXX, for reiterates of the XXXX operational use $XX XXXX in utilized million million. quarter company XX, As of activities. short-term MediWound in be compared million The and million to for MediWound cash cash had in $XX of XXXX. investments, its as million

$XX.X In have that, proceeds, the now gross the addition to sufficient Ofer? $XX.X the cash through to proceeds I offering I'll fund were turn XXXX. equity from $XX.X back expected providing million operations in Ofer. million company’s net concluded financial call received in With overview. the October in

Boaz. you, Thank

we that this momentum trajectory Our very continues into a year build. believe We positive and to XXXX. are on through

to As meaningful I revenues in significant the mentioned, ahead follow. marketing NexoBrid anticipate expect and Japan, have we catalysts United States, to approvals and India,

our up manufacturing we As our to to are demand. facility revenues ensure the able increase, are meet continue to scaling we growing

Phase billion opportunity pivotal our into EscharEx. design and program are move will $X profit. our year a X This We with be next development confirm ready to definitely market

about in call we to your my plan look MWXXX With more now development is carcinoma. our Finally, to it forward for sharing basal open that, questions. pleasure cell the Operator?

the you. will session. begin now question-and-answer we Thank [Operator And Instructions].

from Our first Jennings come Cowen. Josh question ahead. today go Please will with

Hi, good questions. Ofer, Boaz. questions. Thanks the morning, I taking two wanted for

EscharEx. First on

you're like and about Sounds to the in of of making the FDA front progress get Phase X program. nice propose there and final the design

And wanted remind to any Just just Japan the forward the contributions -- just of in to should revenue in Vericel with approval would then that just taking Thanks own And strategic push/pull locking as whether payments FDA Boaz, our potential locking of NexoBrid that then and NexoBrid be in just on to United the India generation to for a design for timing there to in in involved of having us parameters. revenue States. be contribute program moving launches any design a be trial be any the have the and team see also and FDA on maybe in terms that in it'd may radar milestone launch helpful. there's terms in their of gets have the to and on the timing questions. front ready we helpful want for

you Hi, Thank Josh, asking. question. very good for

weeks study discussion et step What with protocol, FDA design, will around sample the in you we assume upcoming is design. as the the indication size, can said run So early with. basically cetera. the our we begin for discuss But meet to and that the to next study that the is

interested provide we in of can once that get interested you an agencies. are imagine, the of part are will get very in partners We that the strategic regulatory being And clarity of regulatory as what forward. we also update from answers path

agency way, after will development next go for some the the also to for the how see need the they about -- get also plan. future As DFU, but by that, the from we we clarity

answer NexoBrid question. should I for As Boaz the think

Yes.

So, hi Josh.

payment That I milestone know should after is the Regarding XXXX, BLA think of we first Vericel. approval. million right expect NexoBrid, you the hopefully $X.X what BLA from

In to kind million addition I kind we're mentioned believe be should for India. see first focus marketing in of the order next should and We're look. to $X.XX starting probably range. expecting milestones we that approval and that key that of Japan and That's year, we that

the Aside from Vericel, half they haven't yet should only forecast, but of expecting launching first in XXXX.

Europe Josh? we itself, additional to answer a growth question, have to countries in addition have revenue. you marketing that approvals years will in product few if contribute In we consistent will that we received last which the we like smaller that, that Did -- anticipate the and the

That's helpful. Thanks you. Yes, absolutely. so was great. much. That Thank

go ahead. question Francois next Oppenheimer. Please our And will come with Brisebois from

Hi, taking thanks for question. the

of design we here, is with Phase this any or questions on end the are big about So a maybe of X? in is on And -- update surprise, Phase to kind coming no of many should going design pivotals a there there as X be that just how give just you're any need? you'll successful terms note, the that then the up debate similar

question. Excellent

succeeded we to study the Phase regarding a are to to have robust manner. Phase X going -- very study in that So we similar trying X we a debate, are a

So this what we is aim for.

the succeeded. agency, the update is the will be What hopefully, you that we study question? the and we very aim going path clear close with provide Definitely, it next to our discussing regulatory one already the are We was forward. design very with be about it'll once an that

potential -- the trials that number if pivotal just then on -- -- take of number I'll in of they're let Just you sorry, and terms that. note, the Yes.

Yes, yes, I understand. I understand.

cost as approval. so I of we decided territories -- going additional States said, a the other are go are development marginal, global than So the United the to we to for

In fact other FDA very the the guidelines on -- Europe, it study. study. anything We is one X Phase the we approval. and and the are existing single both need Europe single than believe clear. for same the guidelines API available that EscharEx and use be NexoBrid do a that cut. basis the data don't X Phase will we are -- contain intended debridement, of the very is to with Based to This product same So in clear pivotal the you a need the

versus if Phase Okay. Great. and any market? help the design? then, Maybe VLUs ulcers, about remind the you maybe VLUs us in you And the mentioned venous you leg why go X with discussion DFUs can

is also Okay. good question. a This very

study. VLU are works same have one EscharEx DFU. and X the -- VLU something almost both and both VLU said, Phase debridement X.X eligible know DFUs for We million data with supports you patients indications. the that -- million similar, we that Having and the have for We for the markets point for

quite for painful. are markets unmet medical the VLU very So very, VLU bigger much are same. because wounds is the need The

can't get You them. to close even

not patients So not you a -- wound sharp the do not all. debridement the they solution. And feel feel at the DFU, is -- a don't feel do

So you it can a debride with knife.

as now a that So see you not their are that heal if that you and also that will there the for is there. devices trials gov, ease VLU, out medical can bigger all for the on there with it DFU look, to patient VLU debridement, XXX kind DFU. for see supposed -- something the there to like is go or make to unmet than into pain you appliances nothing that, extremely a of if are is and quicker just clinical you need clinical Add trials

is easier. quicker, DFU VLU patients to recruit indication and the moving will After to able be be we'll medical that the need the approved, population believe having we bigger. So unmet

Please Swayampakula question will ahead. from next Wainwright. go Ramakanth H.C. And with come our

This Good you. from is Ofer RK and Boaz. H.C. Thank morning, Wainwright.

-- So inspection. getting this getting FDA congratulations do the on for situation, approval NexoBrid your getting the to

So sign. it's a good

you that treated is in of of to from where that you have process there this so and see the this are itself? both manage program, who and are and you product, In said in what EAP launching how terms experience terms how been of the terms far. Vericel yourself How detailing XXX patients do helping learning

quiet and The are of review. access So clinical thank that with drugs FDA RK the the last was question, expanded standard to the a program. for you sites currently week. nice is in the seeing patients It's treat you that program NEXT program enable it an FDA

to the well, think market approved now, important which for in are assuming the we we is on So And going as we in still didn't anything patients United are that a consistent of be not that and have a believe results the United keep The Europe. the it enrolling I that see right? patients. the we see The in United standard actually see, that that significant that aspect States. the going we trial, get can it's that of population, feedback to study, good patients we on pediatric us January that from very patients we reported be -- very treating keeps very and physicians that already lot space what with this is don't data most from States makes in a the we it's but results see XX,XXX we care clinical collecting States. also in a treated We is in see in that

accelerate will to approval, one after that we the effort going revenues BLA in meaningful States that United our that is of expect we going are NexoBrid for said NexoBrid become we the is reasons from substantially. that to This the make to sure increase the MediWound. So

terms in clear spread then, a or the India of And U.S. is. Japan, is market, kind as not and India good. Very and as either which approvals probably is in Europe of Okay.

going market? place? different Japan how that So manage a is manage well, market in And have has sense that little to there. you probably bit as a how are I And different you a Do now? planning to in are have you one. think which strategy you distributorships

these two can If helpful. highlight, markets, be your in would preparations that you

Yes.

and very past, that year, acceptance already the and global So as that Pharmaceuticals, I from see is two we markets, which the demand is them I partners. have Japan, given for reviewed. In we we in I the received next of think, we those mentioned pleased with in in think company, NexoBrid we're must Kaken Japanese what healthcare a admit market

As you're in Essar believe worldwide, called with Indian U.S. familiar company it's for about they expecting and excited Germany, have also established also well India, and NexoBrid. company [ph] company. pharmaceutical I also a And working Vaccine, operation pharmaceutical also that the

is learn to about still I more the think Indian there market.

of one size them the probably patients given born all not of On hand, population, under the biggest of the medical a the amount culture, but severe given are care.

it's assuming data working give together both that once million. hopefully next think will to provide together be of XXXX $X.XX look onwards. we'll get too year and India and Kaken, able I to is numbers, So Japan, more But more premature and we into them to and details capital going forward BSV with

And that. on this have. in NexoBrid said, you least compared already then for of what potential for certainly you to at on product. is terms larger potential the the as partnerships, request started have about then you thinking Thank receiving could conversation EscharEx, And Okay.

And do and to within table sure type next your the through are point? So the coming get you collaborators, can that how initiate in that what's study you your months? pivotal at this of also which study, the make to plan six

very question. So this also is good

players X was cannot with They for -- in strategic interested. such studies. -- as demonstrated debridement very are agent our that Phase I told the our So you that ignore topical just demonstrated qualities

of have from everything licenses kind capital MediWound were we to So At because very own. of proud flexible by of kind that do textbooks, finalize since have all And the to XX I'm the clinical very this out able XX in our be are collaborations, that succeeded are financing, in we trials. are stage a we very to-date lucky options licensing, all companies. all to of of -- we territorial them

the have in partners hand. capable in are operational are but another the partners is potential a of think we we that. -- winner lot definitely we There the So MediWound competition around currently trial. significant succeeding aware very of a and -- flexible we is are have in of The MediWound, team

not going going to are are very we choose. what -- be So we are if we picky to and partner

there questions time, closing in for no this queue. are turn further would management at the I back to the remarks. to And any call like over

Okay.

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

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

You may now disconnect your lines at this time.