MediWound (MDWD) 10 Nov 202020 Q3 Earnings call transcript

Ladies and gentlemen, thank you for standing by, and welcome to the Q3 MediWound 2020 Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to hand the conference over to your speaker today, Jeremy Feffer. Please go ahead.

good and Sidney, you, morning, everyone. Thank MediWound and provided today, of issued the a results financial XXXX. announcing release a quarter press third Earlier business for update

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

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

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

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

Chief Sharon? the would Sharon to Executive like to call over Now, I Officer. turn Malka,

joining good afternoon Thank you, in earnings for Israel. our our to Thank today Good call. on third everyone, XXXX you, morning, quarter us listeners Jeremy. and

quarter the achievements team pandemic. our of continued of challenges as COVID-XX navigate through We the are our proud third to

NexoBrid financial quarter preparedness. strong with with emergency our driven growth very compared year, are results BARDA third prior revenue of generated response as We pleased by procurement for we the by

by patients our In standard of burns. in highlighted NexoBrid was addition, the with providing third important a quarter for severe as goal removal new milestones of Eschar several care towards

BLA target First, in accepted mid-XXXX. us with a NexoBrid the and the provided FDA date PDUFA

Second, the the DETECT XX-month follow-up arms. and comparable study data across patient was was completed, safety all

U.S. stage for of EscharEx. Third, protocol. in recruit access enroll we actively and study enrollment treatment the additional study lastly, pediatric program, our pharmacology to EscharEx we In venous and the to completed II continue in initiated leg of NexoBrid clinical patient continue the Phase next the patient explore benefits ulcers, to in patients expanded studies we

health We continue and the to safety address of prioritizing efficiency workforce while and and operational flexibility. with COVID-XX pandemic, challenges associated the maintaining our

we we uncertainty, optimistic further. remain cause continues considerable that growth, maintain COVID-XX to our and company track on we While are to expect to strengthen

Let some more of recent our color quarter achievements and provide me highlights. third our now on review

as of for generated public build growth pleased a the to first third shipment to national result as revenues see of and We NexoBrid of expansion We primarily territories. further to the mission its revenue the global are quarter, strong preparedness growing health of in part acceptance of new emergencies. NexoBrid product

our first long-standing BARDA. shipment a milestone major represents in The partnership with

the submission quarterly BARDA BARDA, This bringing throughout partial to this million, pro for $XX.X Vericel, look in As FDA the end and we from of a for together accepted is market September, for during deep of removal represents June In the procurement process. valued working NexoBrid we regulatory rata a goal and our initial thickness at revenues NexoBrid full-thickness forward U.S. of BLA deliveries and to review milestone eschar PDUFA path FDA U.S., reminder, in the review and of burns date and the signed XXXX. to with XXXX. procurement additional expect NexoBrid a the and major the XX,

of to data. the pleased patient report analysis including are follow-up long-term III completed that We the we DETECT the U.S. safety and collection Phase study,

As results quality The comparable XX-month which comparable all was, again, signals of which safety DETECT endpoints. of across we months observed. met care XXXX, the the cosmetics, arms arm. function, the study the reminder, its was endpoints. Vehicle, all data, of data its arm, NexoBrid XX endpoint study, we safety reported early U.S. in with announced arms, across no standard III study and across primary all of a of and safety The Gel all and robust study Phase life Subsequently, were a secondary follow-up

the safety no new profile Additionally, safety data the was and consistent observed. with were previous overall signals of NexoBrid

the of with providing the with line study with second [indiscernible], NexoBrid CIDS completing submit in potential half of the severe the from option standard We of current stage reporting the unique severe follow-up giving address important the to step enrollment We patients completion burns XX-month CIDS, for enrollment during NexoBrid data results burns, of pediatric in anticipate our pediatric of challenges care. with the towards treatment a post-approval study, as our of as safety the XX-month of agreed top we is As part recently the to XXXX. this for NexoBrid the treating data including the children goal Phase FDA plan III study, commitment. an announced a stage

additional capacity with the pediatric to centers before NEXT. allow physicians in adult will As the the increase of we date, enrollment enroll centers burn see allow clinical of and as with NexoBrid the analyst effect and expanded patients Vericel patients, U.S. for U.S. The importantly pediatric national of and engaged enthusiasm await by key access preparing in launch, a burn Investor program, encouraged burn U.S. CIDS as and patients keeps for to discussed the NexoBrid We for well in and the expanded completion to $XXX strategically treated upon physicians. to burn is in their the expand XXX additional burn The overview actively followed with patients as of commercial the burns. market addressable estimating of centers of expand us review, NexoBrid during how majority NexoBrid, approval across more Day. the The of to for recent commercial To burn XX next pediatric patients. our centers already partner, target be were use in change the we experience next as more treatment U.S. KOL’s the actively program, agreement access removal to a We protocol treating in across FDA’s stage trained the eschar year-end. which NexoBrid FDA the market burn provided patients with expanded our detail sites inclusion with potential continue the were total in a most thermal protocol customers. of we of it U.S., an FDA, Vericel include opportunity U.S., by paradigm severe expect the could million activate Vericel’s of are and NexoBrid over trained the

team, education, and plan In prelaunch its addition, ongoing burn pricing Vericel sales support cost extensive include expansion reviewed analysis. which its effectiveness and and significant initiatives, extensive of development, and medical

on you Let the me and update shift gears program. EscharEx now development

to and for treatment expect II in an and as U.S. We we having re-initiation clinical sites we enrollment. clinical mid-XXXX. XX venous and compliance policies open begun Phase with clinical in assessment towards the June, study currently leg majority the new continue to enroll U.S., Since continue already of we patients initiate actively procedures, to our sites the interim have recruit governmental in with ulcers patients and across orders sites ready applicable a

we COVID-XX U.S. U.S. its of add clinical continued clinical to before and related in sites While sites considerable efforts additional expect our the uncertainties remain, additional to have year-end, team out to the

such have delay enzymes, of Multiple show reported debridement be biofilm that EscharEx capabilities. consensus additional of can that clinicians the an an may that as burden. biofilm can of bromelin, self-created needs to to such that address other reduction as clinical and of metrics, helpful use its a believe promote burden debridement encapsulated including possible where EscharEx it reduction enzymatic treatment also in provide There enzymatic is a We microorganism to in healing. biofilm, and contributes for healing be studies unmet preclinical effective among wound improved agent aggregate medical debridement benefits promise areas of as independent

pharmacological As initiative with near to our to burden biofilm part area assess initiated our the on effect to about in chronic you this EscharEx more of future. associated clinical the studies details We the sharing explore of as have development effect wounds. pharmacological other of look forward EscharEx, in with well plan we effect as

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

our to morning, and Israel. Thank you, afternoon Sharon, good everyone, and listeners in good

flexibility crisis necessary. prudent COVID-XX would continuously operating like update for to reduction our and we’re while the expenses in to the control reduce additional I if future, monitoring that maintaining cost measures First, and implementing

by satisfied revenue quarter provide also would for BARDA for very XXXX, performance of quarter you We for financial XX%. in an $X.X in of an with were position. NexoBrid to now the third to to by XXX% from the the our I BARDA and million to expansion, with was $X.X on the third like further inflows Revenues ended million, Revenue with the September with resulting are XX, support an September cash XXXX, $X.X the procurement. quarter quarter ended driven global primarily XX, update deliveries our of the million growth of compared quarter our XXXX, cash increase XXXX, of products increase driven third XXXX. comparison

profit to XXXX. quarter quarter the million ended from revenue the XX, a about procurement, As growth a expect in this product million $X.X maintain gross ended of the of for result year-over-year of XXXX was the Gross increased September profit quarter to September XXXX. of about for consistent a margin compared XX% in Gross on XX% to XX basis. we third $X.X quarter third third

$X.X with in an or with $X.X XXXX. $X.X $X.X for the loss of was million September share $X.XX third quarter per of loss Operating included per compared expenses third the third with third operating loss increased BARDA’s of EscharEx million of the margin result clinical ended XX from result $X.X the ended to for of from million, quarter of third a XX million and was the and for development in the about ended development. As a net profit The which were increase operation. XXXX. million with net $X.X for compared XX% compared million for quarter $X.X The XX September sales $X.X share quarter research from quarter quarter the were administrative discontinued loss revenues XX quarter of million or quarter million general, line the was XXXX, the XX% September $X.XX a September ended XXXX. Selling, products the XXXX. of quarter expenses for procurement, in The from of of gross

with discontinued loss Excluding $X.X ended the XXXX, X quarter for and was the third operation XX, the XXXX, move parallel a an loss for $X.X in of license XXXX excluding first expenses. XX, September XXXX. for with XXXX of X months I’d million for of licensing months million XX, of Adjusted per compared months net The was $X.X million prior from included $XX.X as million was ended loss defined $X were million XXXX, related the payment of third million deal Vericel upfront agreement below X products EBITDA XXX% period, $X $X.XX quarter for the the quarter from compared a to were profit, operating $XX.X upfront profit loss $XX.X a financial in share. which reflecting million ended million with compared like the compared for million NexoBrid. million of of and year-to-date now XX, $XX.X an million with Revenues Operating the months to results. XXXX. payment $X increase September ended September the of in the September the revenues period, $X.X X the

the upfront the million a million. of $X.X in was versus of months or The expenses, operating $XX.X XXXX profit for company X September expenses first of profit XX of license share payment, months operating million months and months was improvement Excluding XX% per X $X.XX upfront loss and $X.XX period. related first $X.X the related the compared for $X.X or an prior a net net $X.X the payment deal $X.X ended with license XXXX, first X XXXX of the million million, of X loss discontinued per which share dealer million for included reflects which

ended loss the was $XX.X deal-related and with Excluding September compared of net $X.X the of the costs net upfront months royalty of upfront license XXXX, of of XX, months EBITDA payment million the included net Adjusted for $XX.X XXXX million million. for first licensing Vericel million payment profit loss profit, $X.XX payment, X X per months or which $XX.X X a $X.X a of share. the was agreement, from first of million the for XXXX, of discontinued

Moving of XXXX December as of first of balance remained for Cash our activities. debt. and short-term as in our expectation XXXX, $XX.X to cash with months company reiterate for full back activities Sharon. in now that, was of of use September will million We and operating on to overview, no operational the budget the million to compared X The Sharon? $XX sheet. $X million. XX, its investments XX, financial the with turn I I for million range be $XX our the over XXXX, have concluded to year now With call

you, Thank Boaz.

expect productive coming quarter in to and busy very MediWound a much was it see, can and third the for future. you As

partner, We with for preparation the support process will our with forward review and for to to the working FDA of commercialization, the look Vericel, continue NexoBrid. regulatory we

recruiting are the we’re Phase study, We pharmacological EscharEx exploring patients healing. our actively II U.S. of wound for on and EscharEx effect

employees, we my concluded your we the to continue are navigate patients grateful for through prepared pandemic. open remarks, now and to that, the We the of Operator? all up challenges our partners physicians, COVID-XX and our With call of questions. as the it’s pleasure to our

question from Zimmerman Instructions] comes Our first with [Operator BTIG. Ryan

about there And how encouraging NexoBrid the launch? NexoBrid. Can I expectations ‘XX Is U.S.? they’re revenue just around and their for of one on there. Vericel my the revenue? you little color lumpiness? some agreement Is it could some the the you’re Or maybe procurement NexoBrid quarter-to-quarter? in through appreciated. there BARDA’s helping So see helping And ask cadence just for quarter. procurement just the consistent talk question color be then Maybe on prepare follow-up is a launch with on prepare Any bit how certainly you for this generally conversely, would Vericel to your

good and you, Thank morning, Ryan.

with So first response BARDA indeed of emergency preparedness. as excited we its quarter were part to for NexoBrid of delivery the effort this

Currently, recognize The of million is our the BARDA, in million, by BARDA prorated quarter, procurement the XXXX, in $X.X this $XX.X BARDA to BARDA again, XXXX of Vericel’s subsequent second revenue a Overall, quarterly deliveries approximately basis. is we delivery balance is $XX.X on delivery to from initial and expected followed take are throughout to to revenues place second quarterly expecting is gross which prorated. throughout of the and XXXX balance gross about million the procurement portion. portion,

question, regarding and Vericel. activity Regarding your the second support with

a responsible in U.S. So Vericel as commercializing product is is commercial partner. the for U.S. responsible Vericel the

of As medical sales which reflected an analysis. conducting includes significant effectiveness they are and expansion their It plans and educational development prelaunch of recent of Analyst extensive currently initiative, the support in cost includes and and, course, Day, team. pricing

two, and the they centers one, and and brand U.S., Our MediWound strategically, the in us keep support on U.S. on engaged are program importantly we in we mentioned next is routine Vericel upon with before, with mainly pricing globally the Vericel and and from paper basis a support IQVIA the launch NexoBrid. with cost And BLA together for the BARDA, analysis our we provide with is that. approval. and And and publication Europe expected is them vendor to additional lead scientific and following: key focused running the while next treating are program, as the is the peer-reviewed both, effectiveness conducting

Denhoy with And Jefferies. our question comes next from Raj

us the much $X.X BARDA? NexoBrid of following you of When of that procurement of outside was was tied what just that or NexoBrid of your by you can Maybe last the up how on the about sales much question. quarter, revenue And that to how think product in percentage you United little a million States? did the tell

the to turn will Boaz, I Sure. please. call

question. Raj, thank you for the

outside So billion BARDA procurement X.X $X.X for the to X the billion quarter [ph] sales was and million from U.S. is of

for of impact there sort that it gets in Could of to your or United the the approval? have a and impact as United you’re of States a bit so, OUS? outside NexoBrid an halo effect commercial have year And getting to about any that over Okay. on FDA doing gets is as stamp think any point, potential sort what you sales on approval it the or States next of that

So question, for thank you the Raj.

do which and focused in result or we is, such NexoBrid market First, that, in our market, we the key things: approval. for expectation And following launch, all, some opportunity a and the represents file have market where approval of in marketing do we distributors the of one, the main international launch a of we NexoBrid. the of two X, do expect these as other for additional NexoBrid other first the think as U.S. expect the territories market territories course, growth major that, said for Having can get U.S. take-up to marketing in territories. EU; approval, submitted support markets to

maybe And just EscharEx. helpful. That’s Okay. one on quickly

can trial this to about mentioned the that and VLU interim and come? how look think when that in is risk-adjusted you when anything a you’ll at you for interim trying is. get So is I’m And might tell assessment mind the need interim you you mid-XXXX, mid-XXXX study, this through the When line here there more that that at What firm point? enrolling the assessment. time us is is between in say have about again, what your path date you

Yes.

thank So this for you question.

to First, the last our that of I say since we with in are would site initiation June. re-initiation study pleased like this

subject part additional sites, study, XX We U.S. active in enrollment plan of eventually to related having sites have while remains that evaluate clinical our the do plan XX required We the sites and arrive to our to which in the is additional effort have get to pace having add efforts is and as U.S., active time governmental address XX begun second patients the to as sites with before going wave course, out of policies currently expect recruitment, clinical to part assessment in considerable patients. the uncertainties and individual And willingness the more We’re mid-XXXX. ability COVID-XX facilities year-end, are for the interim to them primarily challenges. already clinical this participating our sites the to around of to the treatment. to recently of U.S. team clinical continued of COVID-XX its forward of of majority to pandemic, global of the of the of with policies, believe we and, sites towards clinical increasing

Okay.

So is at there are point, uncertainty, it sounds see let’s be But wave mid- that now like result. as ‘XX. confident second but you’re of will suppose, this I plan. with comfortable healthy a amount date, Exactly. facing what To we’re all in the our worldwide, the we

taking are to we disruption. But are measurement actively address and We some activities plan. potential currently, on

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

to the for you’re that institutions you’ll regard the expansion able is adult for they to under same as targeting enrolling prior to updates. launch, study hospitals where pediatric for are With whom adult as population? or additional think of Thanks the but patients. substantially include Should be into this the get not pediatrics. clinicians increase surgeons either the footprint to within of targeted those and detailed Or the were pediatrics, range we the being previously, strictly those that next of those

in program XXX the To in participating NexoBrid, year-end. U.S. while sites across we with Currently, the that the XX the were to Kevin. with the original successfully the be to additional sites sites treating NexoBrid, enables about about treated XX to activation burn protocol XX Thank up patients with have patients active protocol, by you process expanded treated. goal are for have while date, patients actively question, access

agreed will next FDA the us pediatric enrollment study Now the the pediatric and for include with impact of completion it to and one. stage program to the allow also be expanded has and

different population. are treating correctly different of adults We teams that it’s some different In burn dedicated will of the the physicians, sites within are but Most and of you asked. pediatric, have cases, additional sites both There for sites number clinicians or that treat. are limited pediatric most can centers. sites,

to anticipate we number So we, burn NexoBrid with expand also for treat experience of additional the clinicians to and expand the that with centers of sure, NexoBrid.

And regard appreciate TAMs in the up pediatric potential for I U.S. granularity with on the to the that, following subsegment

centers of should access general do some I think out pediatric those X,XXX to many of think able portion, relative you’ll typically terms or treated protocol? the the how a of in gain in you How And sites? about X,XXX, next patients. through by around you concentration we think be called the patients are terms the of

I the cases, brand we number, overall I just estimation. pediatric. for burn study. also population you saw that also now specific protocol, rough the I expanding of And of sites in the population some pediatric, process also of centers XX% study activation give the the it of in is treated the don’t other opening same dedicated that assume of on can study in we teams. the pediatric and pediatric but the see is that for adopt, conducted. have we treated next in centers exact We are the a in it And balance or now by we where additional

Cowen. the our with question comes Josh Jennings next line And of from

it’s on may the any what us I still wanted entail? questions update The more in a burden. but you community terms investment EscharEx. may results? on And color know actions you early pharmacological exploration effects just the to I when days, couple these on biofilm can of give those of of focus

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

we needs the areas can remarks, clinical of prepared debridement on address that in the other believe top discussed of chronic I benefits additional wounds. EscharEx provide medical and of As unmet

them biofilm of is reduction the the burden. of One

an of the API, is demonstrated the you that As as of promise are know, a and dealing our component reduction. studies of of And multiple consensus clinician a key product, biofilm. the which clinical the that probably about there is enzyme there our since because treatment wound show among delay effective bromelin, of

of more and regarding first of to to the in sharing the explore the development QX studies status we with now pharmacological effect look are and details plan we of quarter studies. pharmacological EscharEx and assess initiated those you So pharmacology forward the

about value-creating effect And interim trial this year then details the EscharEx big after do and could of if strategic continues burden. deal to value and long did up we you in on the program assessment, you’ll biofilm to potential you the just be other seems there see think interim process potential When to things as mid work -- EscharEx would have the that events around next you what analysis mind open some as unlock where in the a this out, NexoBrid? a anything similar strategic with Is that commence? enough your where again, process second strategic and

Thank you the question. for

potential So But this interim study. that this see but is results something to line or the assume can a the future, top final positive assessment accelerate results definitely, in I process. of

we support out study And may data-driven towards of of will that support BLA. company, and development key development the step further are believe next next market. Phase data with reach the or players II X, of We FDA or care of potentially one the any a discussion the in potential this regarding discussion stage wound

Swayampakula with Wainwright. next comes The from line HC the of question Ramakanth

have Most of questions my been answered.

them. a Just couple of

terms there XX or centers are, In at the I conducting the study said you this next you’re think, U.S., XX in open point. of that

reach idea additional an the is, have goal? your one. of second the you how of so of question reach add ‘XX, number when data time the That’s your DETECT you analysis many other point you do to complete For analysis the do half number need think to publish you to you would question study? that And in it’s an centers optimal of

Thank you for question. your

final analyzed. of have in we quarter will the with second first start the of full the so We that study study. assume and can DETECT we the I’ll question. have So XXXX, I now a the have set data completed data thesis,

because As be during data agreed they unless data XX as a ask FDA, commitment will review the post-approval it’s already with will submitted the for process, available. the safety months this

for Regarding your second question next. the

to So NexoBrid, sites. treating described plan that patients with active correctly sites we U.S., in XX have we XX the have about and you currently

BLA approval approved, We X, will protocol the the launched treating and And going -- a product such study keep time, pediatric product will population be this BLA. months under this to the patients we the will following from forward. be X will enrolling next be the keep until will point in of

give about the to label include a of you patient, included? us an at of are we this, market the if in that Talking looking pediatric population what the you want you expansion sort to expand have group patient idea pediatric can once we also can that

for question. the Thanks

specific first of So completion treatment the step the an study for NexoBrid of providing pediatric all, of of for goal towards is enrollment stage important our the this population.

expansion in NexoBrid of treating line unique potential follow-up the on data, this the data based while of we Given XX-month believe submit can the indication the from study, half top to of FDA the We a on NexoBrid follow-up the XX months XX-month follow-up anticipate results follow-up address experience reporting with challenges of burn the data, data second the the children. including to Based XXXX. that our the submission. DETECT be post-marketing pediatric BLA, we and study will the

we first half accepts of pre-BLA our submission XXXX. of FDA XXXX. we to so, in meeting FDA submission have plan, the the the if And anticipate half second the And with plan a in

Thank you. time. further showing not for And now this at further to back I’m management conference any remarks. to questions I’d turn like the

executing and great call. market day. Thank and Bye-bye. to update you, year a We have next Thank everyone, on and look to therapies joining today. continuing new our XXXX our for us to you strategy you, Thank on again full update you, operator. bringing

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

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