MDWD - Earnings call transcript Q2 2024

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Operator

Good day, and welcome to MediWound's Second Quarter 2024 Earnings Call. Today's conference is being recorded. [Operator Instructions] At this time, I would like to turn the conference over to Gaia Shamis of LifeSci Advisors. Please go ahead.

Gaia Vasiliver-Shamis

Thank you, [ Chris ], and welcome, everyone. opened, the a XX, second market financial release XXXX. the for results quarter before MediWound press issued announcing Today, ended June

the Executive of MediWound; You company's Luxenburg, Development. Chief are release that and Hani of Gonen, Investors Barry Strategy Officer; under Corporate Wolfenson, Ofer Officer may today President tab. With Executive on Chief Financial us Vice access website the and

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

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

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

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

Ofer Gonen

strong us you, are as we to and results morning, joining you today good everyone. excited Gaia, share of quarter. appreciate the another We Thank

goals: III we pleased the successfully diabetic leader the of I completed a plan for am quarter for the to million has the have funding two. Moreover, product's in EscharEx. our Phase EUR of pivotal ulcers, accelerate to strategic as and of remaining become construction to third, that we revenue year, our XX.XX well we total include the At facility; we manufacturing and of to the new in on report first of second NexoBrid; to growth to beginning tissue X trial execute complete EscharEx indication clinical global the continue First, significantly key goal, The we to initiate achieving to the our market. second, repair. increasing the been company, expansion awarded track foot addressable set are

$XX leader, technology million our financing Mölnlycke, position. and led strong confidence financial also in We significantly reflecting in by our enhancing raised industry

eschar drug NexoBrid, me for update with our Let an on for begin burns. severe removal

our manufacturing hospital nearly completed reported to construction a growing with of XXXX. initial a patients number continued prior committee already increase The of over the us centers orders P&T revenue quarter. treated process state-of-the-art XX have aim by Vericel to submission we placing begin soon, capacity the by XX% in new the new approval will allow the manufacturing capacity obtaining for the strong to of the orders. increasing our commissioning NexoBrid the to Vericel we demand XX have driving States, full product mentioned, and operational momentum. GMP Approximately of completed compliance achieve will global launch support build and centers of growth burn notable over all As in them facility facility United The sixfold. In NexoBrid. and NexoBrid

provide soon, very patients burns. option the of with thermal for pediatric a for we would pediatric NexoBrid severe crucial Additionally, indication approval anticipate FDA which treatment

removal to program. NEXT United maintained provided States physician burn the from for protocol, successfully its across burn of patients, the conducted NEXT access victims ensured KiP and program data safe thermal study in role XX% III NexoBrid This NexoBrid reinforcing surgical The Initiated burn in -- trials, in the agent body that ongoing and ] cumulation at standard care expertise We results also from to of treatment covering centers continuous safety had the reaffirmed from commercialization. up the are the burn NexoBrid. The effective XX the for positive NexoBrid United severe patients. total prior that the real-world children eschar with enzymatic with XXXX, centers DETECT successfully States to consistent availability the access will area. finding play this reduces with was in clinical and enrolled a burns the critical XXX life-saving of and burn XX need NEXT the was the and as XXX including surface role clinical [ adults data protocols. NexoBrid Phase procedures facilitated expanded

of very United our remain with NexoBrid, government Regarding the room the formulation stable strong. a partnership States of development temperature

the ] nonclinical FDA the provided plan, strategy. guidance plan regulatory on CMC During our Type recent comprehensive [ and meeting, development

clinical that initial in research the We we The support our and DoD [ us XXXX. on be an able indicating trial feedback our trial development clinical has ] additional also to ongoing design, million initiate will $X.X activities. received awarded to

have study amputations, DFU treatment infections will of for and serious even and XX.XX European been and Commission funding to the received in ] or expansion our for EscharEx's EscharEx, ulcer, chronic including complications this Phase This a therapy indications competitive exciting million projections ulcer market. preventing expedite wounds, revenue a II/III facilitate include EUR foot highly [ several years. the death. from funding Preparations diabetic foot is DFUs, developments. critical underway. Proper of diabetic underserved program. We X to now currently associated to there through Turning our Notably, debridement substantial are will the innovative by prestigious

patients, X.X either every with XX% will painful we XX Let's will look patients in ineffective patients and or these require the with treatment. XX% speaking alternative their DFUs million surgical debridement States, of about Among the a numbers. in at year, approximately diabetic United procedure the an are develop lifetime. million

transforming the of quick care benefit diabetic dramatic a a safe treatment foot Our the very potential standard and solution, simple, impact a has significant millions program ulcer, the to to the of to current on of patients. have

trial debridement eClinical We finalizing III XXXX II of Phase demonstrating were will XX% published upcoming structured the enroll study the at the Phase a III We study ulcers, venous to superiority after the the success promotion have as randomized EscharEx's of XXX Journal, prospective, be for providing and these our recently in healthy our second the treating sites. completed Phase over Phase placebo-controlled global II the VLUs, and The in results across multicenter, An of half is trial. start for preparations assessment be patients will are successful conducted standard-of-care granulation XX the Lancet planned. Phase efficacy nonsurgical trial. trial interim our study the leg design one aim tissue. The replicate insights also of over and and will Medicine following This in of early of the II scheduled trials participants as into of of EscharEx. to

players. program on significant progress has multiyear Our the industry plans our EscharEx reflected from in prominent ability and NexoBrid attracted of consistently as interest strategic to execute

significantly This Healthcare, private position. investment our in $XX investment technology recently, confidence and our leader we global strengthen in Mölnlycke led care raised demonstrates the by Just financial million solutions. a wound

strategic our a us agreement potential also strategic insights participation Mölnlycke's clinical them. certain have with expertise Mölnlycke's in regulatory we value and processes. to substantial create collaboration In addition, ], strategic to This and collaboration pretty enhance access The educational M&A signed includes partnership long-term This stakeholders. for and [ with aims our agreement it's provide and plans resources. discussion

hand Now our over will briefly it review Hani I to to financials.

Hani Luxenburg

Ofer. you, Thank

our for primarily was Gross changes margin was for $X.X of same XXXX. increase compared the second in Revenue XXXX. quarter. mix compared the of to million, to revenue XX% million, attributed in of begin from gross of and revenue million $X.X profit XXXX the the decrease nonrecurring quarter revenue million revenue quarter revenue representing representing second This production in period quarter costs. is XXXX is in me $X.X Let in mainly second the second The total of due with to Vericel. to the $X.X X% total of

quarter in for Turning Non-GAAP of of to of warrants. compared driven to due expenses EBITDA of second $X.X to $X.X the quarter second of quarter million million by XXXX. Net quarter or to million was XXXX million is of in per period second XXXX the quarter R&D $X second quarter expenses $X change of loss for in same $X.X the net quarter $X operating the This loss for of compared million of Operating share the the second to of million a loss $X.XX $X.X adjusted compared million quarter to of of million period XXXX a second $X.X second of were were $X.X to for or XXXX same per for XXXX. in loss in the of $X expenses. profit the million an of XXXX. the XXXX. million share the the operating our XXXX. SG&A financial was was revaluation primarily a compared expenses loss compared $X.XX XXXX

These for the with The of revenue highlights. half half XXXX. Vericel $X.X million XXXX Moving of XXXX the the from from of first increase the revenue half SG&A or million was first for revenue attributed half to $X.X increase loss warrants, expenses in due half the a EBITDA is net U.S. of mainly down Department half expenses $X.X an for million or of in revenue of period the first loss contract of half compared a of of million the for decrease price. Adjusted Net XXXX to of financial a first completion in primarily million was or in and is This $XX first loss million, from XXXX primarily for of to for driven Total per million of $X.X of to half Balance of financial $X total compared half were of first compared million million net million, from million, in XX% of share the $X.X $X.X sheet Gross the same XXXX million the operating half highlights. to of Defense. million by the our increase a the XXXX. half XXXX. our of loss compared $X.X XXXX or loss up amounting was to was the expenses. per in Phase of to are to to due $X.X the $X on loss $XX first $X.X XXXX. Operating study. XXXX. year-to-date XXXX. EscharEx total profit share half XX% $X.X in the new of in was first to for first $X.XX first the in XXXX half the first million $X.XX the XXXX. R&D were first expenses of II the first The share of of revaluation $X.X million loss is XX% compared

and the I of had exercise cash for June to million On XX, fund Ofer? $XX utilized XX, cash a our of company will This cash raised of deposits XXXX, scale XX, to PIPE July company million back in offering. turn the up. As million concludes $X.X $XX.X half warrants. restricted successfully first of CapEx, totaling review. through the allocated XXXX. A equivalents, its as the December activities company primarily $XX.X now and XXXX, $X.X XXXX. In from This first of the Series to to company the The Ofer. $XX.X received million the million the included half million call compared financial facility

Ofer Gonen

We facility expanded Hani. target for successfully This of one quarter. with EscharEx collaborated completed wound as was construction planned. the -- in NexoBrid another our our raised very a market care Thank world, very significantly companies manufacturing the of you, largest and the capital, strong

Operator? turn said, are with an well like we the for forward to need the to all look year. With the goals positioned now exciting any to questions back now have. We I'd achieve may to this and you operator second our resources of half

Operator

today's Josh Jennings Cowen. Instructions] [Operator comes from first with question And TD

Joshua Jennings

understand progress to ] from It's kind steps NexoBrid mid-XXXX? for wanted in capacity the that I expectations partners XXXX to NEXT constraints Japan and that on capacity congratulations the how NexoBrid on Polymedics facility XQ. in you build-out better and unlocking and I increasing and Just all getting completed. just or early to to see great managing occur in whether start eliminating could are distributor India or your of Europe? [ wanted

Ofer Gonen

Thank Josh. you for the question,

the States, have considering awarded around So indications, recently, you the pediatric we expansions be And very Europe, military market were the in United the United including we to launches States waiting growing of as know, population that dynamics Japan, -- And also use. working governmental shortly. and NexoBrid, we India major is are on a also, there interest. are we it in was for

that in making our as NexoBrid the for will escalate the assumption the [indiscernible] manufacturing sure lot we of rapidly. This reason new So complete state-of-the-art of we planned. construction spend why demand the is facility a that

question? the the is of earlier the in XXXX. reflects to soon. process. stability, includes commissioning be execution. I so is expect be It and your that, it United forecast It expect calls, -- are earlier. States, expect can European to be months -- a We said I the it of X-year our at very approval in you we to starting this previous as X we answer And can't it Having stated in Did end XXXX, be

Joshua Jennings

You trial, that a [ to onetime of I was come get II/III a deal funding funding the [indiscernible] to kick did. big of XXXX? VAP a And capital? could could the is mechanics with fund ] of off and the be should tranches, off thinking you just the this understanding better in this Phase EIC And access kick it How And -- hoping the DFU in do trial? just we it. for the trial capital

Ofer Gonen

for as you Thank this well. question

to be to final going Phase ago, very diabetic that. authorities, regarding year our course, on we from structure all notified this will -- of the think to are to get the years, So it is EMA. We get to the with just will anticipate we the do and to the that that, III a to along We we which the for line. the this have that of this anticipate a feedback were it plan the be and also about initiation trial. and for with but -- few regulatory the funding venous weeks take trial, X need negotiate will the of leg our setup FDA and we kinds that MFDA trial After And with it dedicated similar be assumptions based clarity we trial activities first ulcer.

mechanism. for As the funding, a it's

see never million EUR in balance will You XX.XX our sheet. those

fund expenses, We get just reimbursement Hani, quarterly? basically, it reimbursement, these is think, activities. will I quarterly but quarterly. on it We'll should get

Joshua Jennings

VLU last ] then And Outstanding. one EscharEx just one [ pivotal study.

potential been this in just question the this Sorry -- -- answered has and ], FDA? if both in interim present enrollment prepared for X/X development help submitted kind I protocol the approved that Maybe I for the just by should initial when missed [ know remarks, about the to of be and timing your program? investors VLU just you've on us getting of past analysis think catalyst this anticipating kind but that

Ofer Gonen

for second on in as initiate So study, Phase XXXX. are the the the trial we half III track to of

are for We for FDA. approval protocol to about the final the submit

have we this is be done task our very about to presentation shortly. the website at look that can in that You showing

activities, on contracts which We the setup means all medical signing the with centers. are working

those. insight have this half of start is about XX we X an that look months recruitment should of or year. around should the be the after of But study between the the will interim the itself and in recruiting an EscharEx. of trial expectation current early We year second XX The in of of months X We have with start-up the patients. getting activities XX% efficacy after

Operator

from The next question H.C. with is RK Wainright.

Swayampakula Ramakanth

quick of questions. couple A

on capacity. the facility expanding the -- manufacturing for On getting commissioned

EscharEx question point for mode? this know on for study? to is get I the needed you this What folks II/III That's number you're that for start what And that you a two for protocol Phase number one. So into achieve facility a you on question so else is do -- manufacturing need study at clinical to indication. driving DFU. start can before that to looking that trying

Ofer Gonen

you Thank question. for your

up. So let manufacturing start scale the with me

the construction that we completed just planned. as as So said is

scale, we that to NexoBrid do months it can that manufacture Xx manufacturing, stability. of to you making through few in able a go After few start that, sure process a batches It's you everything need scale. takes you Now need months, a manufacturing. X of were start do Xx in to that you and

will submission after is it manufacturing. NexoBrid So practically a that process to takes there time see basically And X stable time around of waiting be is this then it well. as months

is a this what be we times So needs maybe done to in the that past. did few

potential see don't any So I delays here.

more see leg question results practically that see we of diabetic two -- works -- DFU, better in a three see results. or Like don't of XXX end had ulcers and them Having trial the the that in studies, going ulcer other. included they venous leg patients we We knowing are see point. foot to we have -- regarding Phase III this have ulcer. we with do -- hit efficacy the With patients. ulcer, are lot can venous we that we the diabetic said show that, second the II indication did we showing Therefore, ulcer patients for it fewer foot similar with Phase As foot patients. the to diabetic a confidence we

an see clearance that an leg is we that. again, then the a is, let's regulatory the a with bit agreement on see what very and we right Having that similar know need that venous and So in little interim agencies see have we patients, patients about and track. do and say, the we said ulcer to from we are foot need the ulcers, we what our larger between, about to XX% diabetic of to in of the that, will -- of to trial to clinical EMA that, FDA and after look after in see thought get we in XX%

drug care. XX no the years, As you approved in for know, was past wound

So FDA. we something it's that sure know the will not accepted by it for that be

Swayampakula Ramakanth

-- can that results is, just the Very either are data then U.S. obviously, data you with pathways? in ways commercialize you what good have that EAP or use it's the [indiscernible] before. product? additional But to seen to this that that receive ] I'm we which elsewhere, that ways can trying good. And there for how regulatory utilize Or you achieved the [ similar

Ofer Gonen

sure I your I'm not understood question.

again... So

Swayampakula Ramakanth

Basically, [ ] EAP the to... I'm that's how utilizing what are you data, trying

Ofer Gonen

trial, trial. to III the will do data a ] EIC recruited States. going patients will of the Half XX data, global probably we're [ be The be Phase It patients. it's centers, a XXX United the in

Phase So the it's ulcer. III, is timing. the leg a like only Phase III The in venous difference

will We year start it X later.

Operator

[Operator from Michael Okunewitch Instructions] next And the Maxim question with comes Group.

Michael Okunewitch

essentially off, a you about a study? guess study and potential similar Mölnlycke on then start bit investors, $XX just given to that And million that the how from you're could to you're fully funding expecting study? with I funded cover be to it the to little would the VLU talk EIC expecting much be that other DFU

Ofer Gonen

Thank you for the question.

the that Maybe we on in to infrastructure based a X is is that another is here It's have to MediWound. that at MediWound. we recruit assumption all support study people order people or need study in X for Our or cost that. the X X

fully means led capital assumption we the have the cover So closer covered. study, is study. All rate wasn't we sure activities giant by in it was support that to from it raise The to NexoBrid, become mean Mölnlycke able to all we DFU to will that. the make our that activities that capital Mölnlycke such a financially did here. be The VLU it means to the and field are the

more than now to cushion support strategic a activities. those We have

Michael Okunewitch

the like similar that for so a if expect VLUs? DFU would as [indiscernible]? -- and Mölnlycke then component would would the you you MIMEDX process try obviously, then so, collaboration would partner? also you for a you but same have And be with And use that go to study And you through would need same

Ofer Gonen

is the the EscharEx. yet, although we'll this study to same global that can players for in we care for we can Eventually, trial around The great or players This interest the the we a question. are participating is large need will players interest not tell wound a around decision as that just this all take want in there I in players tell collaborate very I others, sure, with well. you huge field. around if is you among the

Michael Okunewitch

about me, just of for last And one in the interest one EscharEx. kind vein in same

of III. care in mean wound largest Phase I So X the on working with you're players that

come had You Mölnlycke and were those unconfirmed there for on acquisition collaboration and equity rumors.

just receiving ask are about inbound So for MA? EscharEx I on wanted or interest partnering much to how you

Ofer Gonen

wound an would is difficult comment find said Having or I on -- it's cannot company is course, to a not have large not I or say to be can a world of access in interesting comment that in rumors it So you can that, question. sure I'm can potential very and advanced party tell this the the that care at collaborating the EscharEx. maximum stage. company interested that I This speculations.

Operator

the this in no does like to call turn the And at Ofer further would question-and-answer over there And any queue. remarks. to for I session. back conclude questioners Gonen closing this time, our now are

Ofer Gonen

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

Operator

has Thank today's now conference and START may you now presentation, for attending The disconnect. you concluded.

MediWound (MDWD) 14 Aug 242024 Q2 Earnings call transcript