MDWD - Earnings call transcript Q3 2021

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Operator

Good day, and welcome to the MediWound Third Quarter 2021 Earnings Conference Call. Today's conference is being recorded. At this time, I would like to turn the call over to Monique Kosse of LifeSci Advisors. Please go ahead.

Monique Kosse

Thank you, Sarah, and good morning, everyone. a XXXX. announcing issued the results MediWound quarter third today, press financial release, for Earlier

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

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

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

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

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

Sharon Malka

to good our our our our Welcome you, discuss business with U.S. in to call highlights. financial quarter third listeners, morning Israel. Thank XXXX and results you afternoon conference Good provide to and to our listeners Monique.

very portfolio. making weeks, been progress and quarter active have across our We this the subsequent

both following NexoBrid in FDA, continue forward Clinical programs. readout. gained increasing towards A some the and with Type We to the nearing productive important very of We regulatory significantly BLA our clarity a value program data we events Development advance of the EscharEx are path resubmission and meeting on lead for

our with on an by first our with a NexoBrid Starting begin followed progress clinical review made EscharEx, a of me development EscharEx program. program Let update in the plan. significant we

as We EscharEx originally planned. complete busy ulcers. we enrollment and year of this expect enrollment this to XXXX near treatment top-line II of the report currently of leg our design Our quarter ongoing in has been in trial anticipate for earlier before end team completion data adaptive Phase of than from the very venous the first study

Gel also initial Phase our with VLU. generating XXX conjunction As the team a and multicenter reminder, year. track is on of primary this of designed this end design to trial pharmacology study on EscharEx II safety Phase II adaptive our The placebo-controlled in study, patients we Vehicle. for by on of our debridement a prospective debridement in randomized been are endpoint data In of incidence study and complete is focused with in efficacy this assess executing trial, has compared

happening to both and in after wound during gain the of reminder, debridement healing. to ulcers. EscharEx study XX leg assess wound effect assess understanding and venous pharmacology both single-arm to patients with bed, a of and open-label, EscharEx trial ulcers designed pharmacological up an foot a impacting As number in clinical the the of to diabetic effect is aim We better is in what

this in in paper. the model. Care, Journal than available porcine commercially be on comparator product EscharEx eschar more a we EscharEx are showed Lastly, very head-to-head peer-reviewed study Wound effective to in well-esteemed pleased collagenous study of see to EscharEx, the our eschar The in-vivo of removing published the

are very much become value forward having wound believe growing with add market. portfolio. changer to game the our this data we chronic to believe the We to We debridement and EscharEx has soon, a enthusiastic in look from potential program to trials which both

NexoBrid. A with on is forward and had Type the questions recently address information by agreement a to FDA, Moving productive there request FDA. We the the to path where the

to continue by BLA review NexoBrid and patients centers program, X-month product potential U.S. enroll partner to Ferritel run mid-XXXX. as bringing leading look access through We as year-end about potential innovative U.S. at market with forward we We and the a XXXX. for a and in to which anticipate will we're potentially the expeditiously targeting In to burn possible. with long-term approval a prospects next and currently approval. BARDA, period tandem, resubmission this We enthusiastic continue the expanded remain to new

degree clinical thrilled strong severe study top-line with to burns, efficacy are announce profile this quarter NexoBrid III children from with of thermal We results of reinforcing met significance, Phase statistical safety high in the earlier positive of product. the all its endpoints our a and primary which

those further Following during and we other expansion to of NexoBrid. expansion global XXXX, enhance Europe markets for growth data and in believe the and label planning are results, international submit it would

are the BARDA On we growth, the the continues of related the traction gain we end remaining commercial by third and quarter to front, procurement drive globally. revenue BARDA's and to stockpile for commercial revenue to recognize procurement continue the expecting XXXX. Europe in to emergency product

United XXXX. as Japan, our come Taiwan as lucrative execute around see revenue markets more Globally, and We addition, In more centers in we and on recently Arab we burn sustained standard to of NexoBrid marketing and others growth. Emirates in such global embracing more continue India strategy care. received Europe, the expansion anticipate Ukraine, with and to approvals

product Carcinoma data non-melanoma first half II running expected the initiated U.S. in I/II of parallel, skin of Basal for in Phase is Phase both recently a with we study XXX XXXX. cancer Lastly, a Cell in investigator-initiated trial from treatment low-risk of and the

for our summary Boaz Boaz? over the call to of would like a financials. I Now, to turn

Boaz Gur-Lavie

morning, good and Sharon, you, Thank everyone.

and growth of with outside U.S. as the the continues continued First, territories. of gain market NexoBrid I'd profitability We're U.S., increase our supporting product outreach the both to into from reiterate balance traction a NexoBrid. our sheet expecting to revenues ex-U.S. and new revenue like growing to our

sequentially. was to for for and expansion Gross related $X.X with of procurement, driven an the Gross our gross and Total the the to for sales to was of months X quarter primarily XXXX third increase of a $X.X for the million the third to Total and quarter of $X.X gross program gross were for in Research quarter XX% $X.X of to $X.X revenues margin emergency for profit quarter for response million the Moving Operating for procurement revenues last the The million the $X.X XX% margin $XX.X million U.S. last first due development of and in for same million revenue million clinical revenues million and revenues year. Product the margin NexoBrid the X the third compared the from Total the of in third NexoBrid this XX% results. quarter compared increased of million, outside third primarily third XXXX. $XX.X the were months the of third XX% quarter of general of profit growth to $X.X for XXXX up X% XXXX. to EscharEx. revenue of administrative a million third this same in $X compared year. development provided quarter $X.X first third expenses were of million to of first to quarter the a for $X.X first revenue in Selling, year. preparedness product to to reduction million period compared Revenues third to in XXXX. to million decreased XXXX. primarily months new $X.X quarter of a increase compared by of quarter XXXX into services million XX% the included BARDA’s and BARDA loss quarter XXXX, sales X financial million last were to $X.X for Europe the were increasing quarter product $X.X of compared million, X% an third year. territories. and X compared $X and million last period the product in months Product of revenues for slight compared to XX% increase increased loss $X.X of development million was expenses year-to-date quarter

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

loss Adjusted net for of million million XXXX, share per loss to $X.X third compared $X.XX a or a to first For million of quarter last $X.XX EBITDA months quarter of the $X.X year. loss X net the for $X.X or for compared loss per period. $X.X a million final was was the of the share

of for compared $X.X months X first million loss the of XXXX, of was EBITDA to months a adjusted For loss million a XXXX. $X.X X the of first

the Moving sheet balance to highlights.

million fund to short-term months in BARDA $XX.X reiterate operating mid-year guidance and With $X.X cash will sufficient cash XX, through the million XXXX be procurement to equivalents concluded year's growth, to believe BLA million to budget, Sharon. million. expected turn and of and compared revenues of on over on the and financial We anticipated to first will $XX.X that, XXXX. Sharon? now were We that range cash XXXX. our remain XXXX. $XX back XXXX, X based $X of I've cash plan, investments current call I and million XX, September cash upon in as we from my operating overview, approval existing of As the utilizing our December With be of expenses for in currently

Sharon Malka

Boaz. you, Thank

look year, optimistic now call the the as approach we end important your in forward we as towards we milestones about is to the With the coming updated we We Operator? programs pleasure my keeping that, of our continue questions. it move As you to for quarters. execute. to remain open

Operator

Our first line Company. Jennings [Operator question from and Josh the of with Instructions] Cowen comes

Bryan Bergin

your start Is FDA This for part review You NexoBrid, Josh. To the did previously follow-up update. done? is be may. address the with intention change I that the areas had on to has in changed safety and the as on I meeting X a have team? Bryan outstanding EscharEx, provide recent work way? Or here And to work of cited additional of to the work scope any still required if your a

Sharon Malka

thank the Bryan, for question. you Sure.

certain answer communicated the is next that the inspection there in a inspection And in at is our more Israel, part are reference short we which preparing FDA no. update, include X one info by are the observation is, Taiwan; safety on GCP required sites; the answer before: requested; we things in and to CMC the resubmission. So FDA detect finally, facilities the extensive third, that the as is additional of routine the

elements X BARDA. are questions agreement an there meeting support that to are and on with overall, And a their we going forward all of FDA, So had again, respond we how requests. funding were to with moving the productive and information the

the being at and work with So that completed, it this done submit package resubmission will the then into is point. be and assembled

Our said, period anticipate by is review approval and with a by midyear as anticipation, we year-end I X-month XXXX. XXXX, potential

Bryan Bergin

results positive, EscharEx, timing approval? a yet trial for as pivotal II size study if And you FDA whether of VLU in can the BFU? X and either X data on or sense you’ll upcoming stand are a have have in in clarity the sets the these on do need you And of Phase do a second VLU Okay. of

Sharon Malka

Sure.

data think stage. the next or at it’s I provide expectation premature point some this So to for

be the sample First, cetera. next of course, have XXXX. the need Phase report course, the et discuss with we share study study. we Once pivotal of indications, stage, an the ongoing and in much CSR the and required, we once step to complete more We results FDA the pharmacology which end the information will meeting, the the we Once half to will clarity, design, then data to with to study Phase II pharmacological size FDA once the discuss second includes, data the the study complete Phase II this II data. have meeting have we and, we able of The plan you. Phase the have to of be have II ongoing the with of

Operator

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

Ryan Zimmerman

follow-up resubmission? on the of within NexoBrid taking Vericel you Just what a have a NexoBrid, on versus follow-up NexoBrid for on the components taking is I couple One, the lead a And on then maybe lead guys things. well. what are as

Sharon Malka

Sure.

with bringing and which a NexoBrid is and know, partner, of NexoBrid market as BARDA into within organization U.S. commercial XX experience very collaboration, course, well MediWound So last the supporting joint you years. the with a as expertise extensive

risk a great and experience of a XX history. itself, to product regulatory the on Vericel As of regulatory and years with submission clinical the teams with a we has vast the deal deal have great of front. experience success operation given the

great are leading So a regulatory track in position we believe record, we the front. leverage to Vericel

the years approval. with collaboration Our the special matter the who and of the that we believe that to providing this BARDA’s experience have team confidence and personal us, consultants us NexoBrid experience, BLA strong with supporting brings best we achieve

Ryan Zimmerman

Okay.

of just could seeing kind that as a for NexoBrid? Europe in more is whether view what as how the sites far as to usage and use do bit goes, usage in little looking, an As and NexoBrid? are of surgeons burn example burns about how of we U.S. you you start use the think utilization Sharon, talk Maybe about should types

Sharon Malka

Thank question. the you for

So turn years I is beginning, we and in basically the think are with of as you the specific if Europe centers with NexoBrid that say, standard in now all burn care. what And targeting the leading that that X.X last, see working started they burns. at let’s

like burns. burn of specific be centers. hands. Sometimes small areas those it it’s It standard some the be care can can in leading Currently,

burn the DETECT limitation, – U.S. Moving leading burn currently XX% are patients in study. XX are an about remember centers centers we areas. than and treating expanded program that the access to protocol to which without XX to in with U.S. expectation, in the burn less the running we to restricted have almost NexoBrid, keep our all U.S., up It’s

tolerant believe And generate will them will of to approved. hands-on experience I market. uptake more that burn of be NexoBrid NexoBrid reflected the in once towards to they hopefully, be with kind So the enable the more be fact also used confidence, U.S. in it more

Operator

Our comes next Kevin DeGeeter Oppenheimer. from line the of question with

Kevin DeGeeter

wound EscharEx, expect I Phase publication? think presentation and safety the to for how hold will the should we some relatively the initial Should topline for tolerability data for alongside guess prepare disclosure? to as update you significant of VLU Or get at potentially or we sort of least II look scope data of healing? about future we

Sharon Malka

for the Kevin. question, you Thank

which followed be expect secondary we endpoint and will quarter safety additional And first data topline data planned. So from earlier will from this referring, it will study, study second and on, safety -- is than this with primary additional the the quarter to one as through of in endpoints we long-term be this quarter. originally it communicate, with which come report to in followed be the and later of XXXX, course, analysis,

Kevin DeGeeter

sure guess, context think of of a Great. lot even many resubmission. visibility And I Taiwan, process. are particularly, defined then that of not question. follow-up just At inspections? BLA mean the steps what a have I’m least enable we we timeline NexoBrid should in I How about sort here the on on currently, the the that’s facility of us

how on So is kind that of detail can what you handled? level of how perspective – question provide currently being at some

Sharon Malka

Yes.

we are So will we occurring. do inspections the – point we anticipate FDA and now will travel the premature you pandemic, resubmission. know, worldwide. dynamic discuss those as happen that’s that still It’s outside the something what a restriction given the once at U.S. But there some of this with some are submitted upon little know to

able in be we hopefully, position the facilities. both to a will we’ll resubmission, inspection following schedule So be in that

Operator

Wainwright. with from the [Operator of Instructions] Swayampakula comes Our Ramakanth H.C. line next question

Swayampakula Ramakanth

quick on of couple NexoBrid. A questions

about the talking EAP You're program.

program of this could understand this undergone many this? how into utilize enroll especially the or you And to have patients going kind into data, you're how when resubmission? trying Just

Sharon Malka

Yes. Thanks for the question.

and So the and adult I Program, pediatric as approval runs Expanded through said, Access population. include, both

NexoBrid of the already to that and goal data continue this we to usage from generate patients protocol protocol. Vericel We treated next this discussion U.S. the ourselves, the new cost-effectiveness actively brand victims across XXX course, data with with is data, FDA. safety into from and at This And centers with both plan the FDA, perspective data U.S. burns support of enroll over leading can BARDA, the date. to protocol this of

Of that as study like or will captured course, patients we XXX the but safety FDA. discussion analysis hopefully, first will this something we'll other, will also with that the have the part safety update support from be part will the the be of get of that -- resubmission, the of data

Swayampakula Ramakanth

Perfect.

talking study, the from said So about pediatric ‘XX. in that you that data have you would

Or at going would that be -- what you publication? see that would that from it publish to data? conference we presenting where you of So analysis? a details so sort additional be some Is

Sharon Malka

Yes.

So be in XXXX. PR. April just which data we will in data shared the I around important the published Not believe data next that year, anywhere presented the next is than less ABA, because this

We this we And are label these territories, it we and planning able this expansion use data expansion believe international of be and to and growth during other submit this worldwide. accepted, it label Europe XXXX in will in submit to if further global and leverage would expansion markets. for data NexoBrid enhanced data,

Swayampakula Ramakanth

Okay.

couple is, of So UAE. question about for me expansion geographies talking last you're a like

areas them partners you? size Do market what's these -- I about. of you distribution are now? the for what you that sort you're think already was the these it like have spent establishing talked And geographies? in in these market other also, geographies Or

Sharon Malka

So expense sustained revenue execute you the that can we global with international on generally growth. share continue on I strategy to speaking, market, our

approvals marketing refer when come in where specifically Taiwan anticipate our countries, already and referring United to Ukraine, to some in approval. that the market. lucrative we reminder, and Japan, And we're markets, we and more distributor the EMEA lucrative Asia received Pacific for recently America, East. Emirates, CE focus a and filed We to in As Middle is in an

India, it of looking distributor and launched where are and We approved it the other for the mile territory, last XXXX. in getting June

Operator

will There closing are questions. for turn remarks. further now MediWound, the Malka, I call of to no CEO Sharon back

Sharon Malka

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

Operator

Thank today's participation. your gentlemen, concludes you call. Ladies and conference this for

may now disconnect. You

MediWound (MDWD) 16 Nov 212021 Q3 Earnings call transcript