MDXG - Earnings call transcript Q3 2021

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the MiMedx Third Quarter 2021 Operating and Financial Results 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] As a reminder, this conference is being recorded. I would now like to hand the conference over to your speaker, Mr. Howorth. Jack sir. ahead, go Please

Alexandra Haden

Officer, you, operator, MiMedx Conference Welcome the Vice Chief morning, Tim With Pete operating Financial Carlson; and and Quarter XXXX good Executive Executive Kashi Kashyap. the are Third for results call Results and on everyone. the be Wright; Operating Chief And me Officer, at to President today's Dr. Chief Thank Pete your Tim provide and Call. financial Commercial Rohit questions. Officer, Dr. a and will of Pete their available for remarks, conclusion and will Tim summary Financial and of our quarter.

Before will we differ subject and to and products. actual approvals statements, remind forward-looking including are that begin, potential size and results and These other due may from and our to anticipated time expectations actions expected FDA our approval and those results our the factors, clinical the affect those a submissions results, market our deems to Actual for trials you trials, of comments FDA lines of that these time interpretation risks today our clinical include would many timing number by impact that COVID-XX, I uncertainties, including of will for materially lines of FDA depend factors and the like ongoing important. factors. others on

and release, which Tim call include website Form annual to on described comments those on outcomes results include provide our in Wright. Factors a our I'm quarterly turn to impact Form reconciliation the on non-GAAP report GAAP our at today Tim? could now financial our XX-K that, our section to Also, Risk that of factors we available and measures, Additional press XX-Q. pleased in is reports the our over www.mimedx.com. With and

Tim Wright

XXXX third Yesterday, press Jack. primary investors. the markets, reporting topics I of call like and three our issued to you, joining Today, results. of a we on and thanks release everyone, financial interest the operating close for Pete and morning, quarter today. would us following highlight Good Thank financial to the

applications our highlights, of of third we analysis Adjusted and Our of plantar the tissue for the products nine also Pete of surgical of financial mid-September pleased core increase report placed of team XXXX that outlook operating year-over-year and first XX% $XX.X XX% quarter. -- of discuss line products. recent core as net line I'm growing commercial XXXX. net our core for portfolio sales ahead recovery adjusted reported top results quarter XX% growth business products of versus commercial solid We XXXX. top by us an believe the well of execution sales our of will of from third portfolio has sales sales sales increase and our osteoarthritis in the as readouts of in include expansion studies into our continued plus drove our and to resources. months which tissue same impressive our our fasciitis financial clinical million the extremely million, net and status and $XX.X in quarter a our detailed

our have caused and COVID-XX by the disruptions We in And places. two major the markets, teams right our despite during the in agency people right exceeded quarter expectations. direct internal

effort. Our diversified this a AmnioFix growth applications, in revenue brand is and demonstrating surgical of number utility that reflects

the size of a additional cost-effective gaining product line with an targeting we're wounds launch our with successful smaller, way. in lower extremity addition, In traction EpiCord

working from as process results research, tissue business as and year advanced the achieved continue positive chronic commercial months and the growing cash expansion and helped is wound our significant nine tissue patients development, in in momentum of Our by differentiation the innovation aggressively clinical driving targeted this acute the into flow The product focus team investments care base leveraging core quarter growth expanded of portfolio and our beyond. achieved Purion treatment strength, positive clinical first has portfolios of well we on to efficacy into technology. evidence-based need sales the requirements, including options. and outcomes for These ongoing operations enable support fourth Ultimately, better are initiatives. our

observed now study Turning top patient in reviewing differences product. AmnioFix clinical trial. in results the knee cohorts musculoskeletal behind two announcing osteoarthritis to to extensively our we late-stage trials determine the been the Since mid-September, data injectable have reasons of line the between

our very These signals the from to product's the with us for in hAC. limited studies, of to along III provides X-month positive Phase cohort results X-month increased reason Phase function both to note the are therapeutic p while OmacPain our with Prior WOMAC our clinical less to As studies, cohort months observation X.XX our p-values outcome as understanding X.XX analysis XXX less or ahead groundwork action, NEO three potential encouraging study. a with for of scores of statistically future confident plan, of the WOMAC Western XXX efficacy pre-interim Index, substantiated from important right in lay months. progress of these XXX the study patients The and future and analysis at micronized the than and IIb is and important they Osteoarthritis Total, statistical and six for meaningful the insights scores Ontario, are significant approach observations. biosticians analysis pre-interim and than decision. into Master's the values in It clinical patients into III a experience, give third-party probability WOMAC, values at part University Phase mechanism the believe increased us retrospective and have validated is for all improvement moving of we analysis clinically

have engaged been We to study forward. hypotheses and the into of dialogue several have with testing points, investigating the FDA guide was all our since play initiated the have data in that come path may

to We rheumatologists, community, working design orthopedists EOA XXX also studies study and well-controlled in patients III Wallman studies as unexpected execution anticipate musculoskeletal this other underway dose, With puzzling could safety randomized FDA indication. are that evaluate can Phase potential other and and and contemporary fasciitis effort the efficacy outcome. and may osteoarthritis the approximately Wilmafunction primary these of recognized a enroll to the knee including of the run concurrently study, endpoints. We key first variables is for and confirm with influenced leaders with plantar have treaters a respect and to to results XXX similar study-related that advise industry the across and

unique upon data safety database throughout data to and well was monitoring already Board safe tolerated treatment to in product. our observations AmnioFix reasons Importantly, options from an The studies, Investor strong Injectable the Day, confirmed both trials rarely continue forward these a formal XXXX. and build development reviewing patient upcoming at look safety process. for our data Clinical meetings. X, for We found continued of linear with these is optimism December

products the need in in resolute commitment to advancing here industry we advancing rigor to U.S. and end, strategy order expand bringing of and At to patients We understanding programs. the and we in and economic in enhance care our improve publication publication are our scientific is medical the the scientific to health three team the our of recently brands. leadership the differentiation reinforce studies to remain outcomes. its of international our value and the markets. patient research action furthering our designed of announced and Our mechanism of solutions MiMedx, peer-reviewed scientific convey education that the innovative and of that clinical to To physicians dedicated

findings. spend of some a few these me Let moments to highlight

ulcers. the caused Care standard published impact The wound that extremity addresses pathetic chronic Journal reduce ulcers observed the in raise study products Wound care advanced treatment expense advanced this first can diabetic patients. of these study provide for and data care substitute The these treatment by the from in using skin and the of lower suffering validation of

cartilage was The second in osteoarthritis published study open. in

by action Here, drug Injectable and new in degrative novel of type we dHACM for the comprising AmnioFix articular These highlight process support cartilage. treatment micronized potential regulates a an results human processes identified further osteoarthritis candidate cell activities. as disease-modifying which Purion investigational mechanism the primary chronocytes, articular of

to Journal in purposes examined Materials and treatment counteracting a the micronized led for evaluating as these complications of which were for Research tininopathy, disease was responsible B. published attributable processes. the These modeled study Part outcomes of vitro inflammation hypervascularity. to third poor The injury Atom mechanisms prolonged in Biomedical chronicity following for tendon identification the specific It in of

tendinopathies research on two development are and demonstrating in our indications, cuff limited Our tease etcetera. rotator clinical platform technology injuries, and to focused activities mechanistic of that a arthritis but not support attributes including number

indications As a pioneer the field, insights amniotic into investigational our this and and study of beyond we in significantly engineering, healing believe placental knowledge provide and additional tissue may to conditions. technology wound musculoskeletal contribute ultimately, body tissue and

trial studies effects of pharmacology alternatives effectively action mechanism the help safe providing function We elucidate more and design believe the considerable convincingly reduce injectable. and and opening the disease others. additional basis to these signal on concludes now will the through take many KOA results. remarks. that within Pete, modify Jack, turn pursue well indication I'll the this of round AmnioFix Our next to is who that provides scientific over is and therapeutic a positive the my in financial the pain, will and effective learnings build for research Pete? market there studies as demand of call know to insights improve us we as and you

Pete Carlson

XXXX I following will financial overview business. full of starting provide is of with on and of first an the third Tim, everyone. Thank This some results, trends discretion. the you, end the enforcement our quarter good update an in our underlying morning, quarter

September prior a the for months in States, these Net sales million. three $XX.X contracts Despite $X.X months which $X.X remaining three of $XX.X of recorded revenue is no recorded million revenue products September quarter approximately decrease in As sales, compared September Adjusted ended loss ended to net the cash the for on $XXX,XXX September $XX.X which of contracts, products, able quarter. total $X.X XX, excludes months of sales to the the the include to on XX, the XX, XXXX, XX, compared of three Section remaining you company of collected XXXX, X.X% recognized United to million. for ended were for current sales from or months we previously three XXXX, the year the XXX million market know, $XX.X represented for longer XXXX, the a million the net sales. net ended XX% million which decrease compared we million,

was our volume inability prior compared adjusted months year. XX, core in of for September quarter Section ended U.S., market overall our to grew to of by million XXXX, the While net the in the products XX XX% impacted and three or sales X, the sell products this third in tissue year to negatively $XX.X million sales $XX.X

by sales by far months making margin and to XXXX. Our into efforts. third Section expenses with volumes quarter-over-quarter. were the the to $X.X for million and for quarter head XXXX. The expansion focus costs core relatively $X.X relatively the million legal surgical count total months driven XX, the higher in the research as ended growing XX, of prior applications clinical Gross September ended lost the lower was ended up expenses XXXX on resulting in months support on for increase Research thus XXXX, decreased revenue, well year, consistent profit growth other three million $XX.X XX, three months as fees XX.X% for consistent September million $XX.X paid has development reflects ended three product from XX, compared tissue the $X.X matters. September for for business general the million administrative XXX three professional and personnel to September Selling, reflecting and XX.X%, in XXXX, off the

much due its studies, R&D in While increased clinical timing incur the delayed expense anticipated of to investments as did trials. it as has company the not

and the clinical for these related were in XXXX. costs months We expect of third compared and plans I company as execute will a million the Investigation, the XXXX moment. quarter for to ended which $X.X trials, million restatement increase discuss three new $XX to XX, expenses September

as not of current incurred directors the fees certain company. officers in of expenses year the expenses the towards advancement year During and legal quarter, prior former significant These former the quarter. of were MiMedx

highly the incur While the and of the some to resolution amount matter litigation moving costs timing are of expenses and related continue action continued company anticipated to in the which to investigation, other class is a reduction related securities than expects restatement uncertain. forward, costs

in XX.X% a the of in Net quarter profitability. $X.X year a same in for Adjusted of sales XXXX loss net EBITDA loss million or at of period sales quarter Looking million XXXX $X.X to net $XX.X or same adjusted XX.X% third compared the was period to of million the third of ago. million compared ago. adjusted the $X.X year net was a

and million XXXX, XX, September equivalents of million of As $XX.X to XX, cash compared XXXX. had as December the $XX.X cash of company

and an sales enforcement end also pre expect summary, that expect million, setback of adjusted is including cash of the discretion the in convey company In although discretion. forward, our our during net period flow our million, clinical will XXX year revenue neutral value of the U.S. between designed XX economic net including in $XX.X will XXXX that XX $XX.X be of initiatives to the the had year continues in growing, in in return we the sales quarter, million $XXX.X product for Looking sold clinical months, the Section to our prior adjusted period. levels sold to to fiscal million multiple compares XXX $XXX reinforce the to $XXX to brands. fiscal XXXX and We business enforcement to unexpected of we while U.S. overall Section differentiation believe This business million driven next this this of be base past by products programs of base and products

business would Tim those costs the we over reflecting investments and of clinical the cash trials business of invest return level financial the than are of after our that less than I XX-month indication, resources, As our described. to cost generation incurred period believe our normal needed to just middle XXXX near-term the in its X-year believe ahead knee trials described to We total pipeline additional existing OA the fund XX-month and raised $XX to that sufficient base think more a these we and to for R&D period. capital for in million be will

great Tim. a flexibility, we tools in financial I do funds to to will financial in the the growth place. call us future turn prudently in in a integrity job and our necessary continues now to team invest restoring and Our now have given position putting back

Tim Wright

step I'd our certainly back is to like proposition. evolving. a strong take Pete. you, MiMedx Thank and value reiterate

Our rate. base business growing a double-digit at is

with portfolios, generating In sales 'XX by to core We're other adding led looking also surgical data to third-party expansion addition ahead our market to for from enables coverage therapeutic growing in our the into EpiFix and in payers. expand uses exploring we products, access with are team reimbursement scientific tissue Japan. revenue applications, that along additional

It of doing the are medicine in regenerative On has objective industry lifting to amazing the the potential scientific is lead heavy We making intent tissue our with of side, remarkable placenta unlocking the the we the set of science. a properties. reality. amniotic that know an

immune of One types being body, the other unlike that meaning cell an those it therapy. doesn't elicit from it's of response privileged, inflammatory

clinical modification our are understand full mechanism action in potential seeing We therapeutic development. working evidence rigorous data early demonstrating disease rapidly to science and also through of

rather in cohort potential years. in than Phase and be of are expectations We further We the delay therapeutic the analysis expedite in our two the confident warrant to clinical results quarters will pre-interim investigation from believe measured in dHACM. prior investment. positive our studies initiating micronized plan and trials III The

to have committed making believe the that to are make investment. and that we We funds investment

large tissue questions. needs have significant amniotic make may you Our open on to for I and you and for the the address Operator, products lives. and unmet your support. markets positive interest lines to ongoing potential now impact want meaningful patients' across thank

Operator

you. Thank

Instruction]. We question-and-answer be will session. [Operator a conducting now

with from the Northland question. come Byrnes Please questions first Carl Our Capital your line with Markets. proceed of

Carl Byrnes

Thank you.

factor not anticipate question or And i.e., were that possible the normalized got may and III may in seeing things in Would begin enrollment if stable exclusion Thanks. with First, a of target data cohort, perhaps when to that of do when But other alteration were Or congratulations well. as in that COVID a review I IIb that the EA. a the factor. a quarter. you the on follow-up the III subjects trials? there that is third-party particular Phase in Phase lead to criteria some lead a the studies be in recruitment inclusion, the as cohort might that environment, the again, XXX you success considering third Phase pre-interim review you

Tim Wright

great Carl, That's question. Tim. this is a

You're which We are the clinically. validated important we the will, third-party validate absolutely did if they correct. think as statistically the biostats, have XXX. there, as And well on CRO you P-values

address trial... forensic the to On we'll think X, have December more insight I in We that particular you questions you analysis relative shape really good ongoing here. complete exploratory this of some our onto pose be to to findings provide

Carl Byrnes

treatment? in that gross margin been just related that a recovery the And can third guidance if the then Thanks. surgical expect Considering improvement quarter And extremity over some to the Great. sequentially at profit would to have forward? GPM factor and a the follow-up. provide respect quarter, going what of fourth be might in wound and you to second with all mix you the quarter was

Pete Carlson

The What Carlson. there items somewhat my of the we was friends to also in term talked had production to Pete about of couple in it's by me unusual, coming related unfavorable use Carl, products we accounting was second a biggest reserves quarter that the discretion. we impacted through. like don't that And variances recorded although batch some of were quarter. a enforcement had

the abnormally So themselves to see we out. quarter the reserves work little and bit low. margin Those we didn't production did a variances gross the have be -- second

we be talked in previously XX% why continue So margins to that to we that's profit return normal the we've to that XX% gross think about. and range, that would

Carl Byrnes

Great, Thank perfect. you.

Operator

with line your Our H.C. proceed of RK Wainwright. questions. next from the questions with Please come

Swayampakula Ramakanth

quarter. and congratulations Thank you. again Tim and Thanks, great Pete a on

growth bit a more the continued that on you're the in So base business. seeing just to comment little

could XX next months, base you in XX a positive that can that cash understand the bit happen Just more so over Pete, you be the you year-end back. in helping what also, can you little there? needs to come what to I mean to business potentially positive. be is suggested as trying And cash

Tim Wright

take you do Rohit, to want that?

Rohit Kashyap

with them Thanks, expanding as are customers early business. value enabling in in the the success year the both by the targeting Again, in as training Great in several right there productivity their and year RK. in the are base factors pleased sales our very that with that Sure. effectiveness improves question. with results our right to well area. team and proposition. that We our investments made tools We're targeting contributing

be our data As new that we in the Pete verified, demonstrating we're as us making more call, helps generated team for said, to in and easier etcetera. value during making customers efforts, economic are that our also like with their earlier products reimbursement our we of sales can mentioned year as as effective health value the in our well the also and have patients this pinning course Alongside that, we effort partners and net well. they get by how to it access clinical

on So which they in we're business we us far. together that year those the very at historically. also about will a come sustainable the that all we in higher investments that us as forward the talked results the help deliver so is grow that of have confident elements have clip, are we go XX% the But helping the sense also made than

very that. do flow? I'm take want cash So to Pete, you the confident about

Pete Carlson

not adjust We needs our made time, to field really happen RK, of Yes. frankly. discretion. the enforcement what end to conscious force with a is decision

that. a revenue. shift in places, the right we want people had in to back right We make felt our need we to the and So We -- grow into didn't

to do just as business, need revenue back grow we levels, think that quarter, to in we And base kind you've over seen have months. that's that to what happens we XX XX% the need so this and the we into and is that growth XX of

Swayampakula Ramakanth

just on KOA have well December data. thank a to do But more think you. interim, other Do a you are to that just about understand preclin the get utilizing satisfaction differently into go to next involved to as little process understand a understand other I'm you PF trying timing be than And on might -- this X larger I'm to before I need understanding. to -- my just get better neon-stage? doing a data, just is until in how little you the and head I understand to to what this to trying how until study? to how to team smaller in as wait need a bit the factors study get to understand trying third-party bio study Okay, study trying going we additional take I'm going would to long basically as get trying

Tim Wright

is RK, I this questions. your Tim. Yes. appreciate

a things understand the plot site, I mean have December view that analysis goes happening if this we'll classical certainly doing analysis, rigorous will. you bio I you what X. to our statistics, fulsome of would think the do I each more beyond all was site on evaluating what's really at do happening. fully think that

able that to our studies this December. discuss having about that. in we're as very the things our think are through developed looking us And understand Dr. reason capture Stein probably is if these type and here, was part has December in XXXX, to were discussion a move do that's of to And at conducting in one trying I or potential but into function MRI, you ongoing forward to that. he of we that that x-ray imaging, some use so think clinical of be is the When study a that you well deployed And tissue more that as important, really think all we total go strategy trials. need three team the And be back should discussing is I of for elements his also capitalized I And in the whether to well. think pain protocol. really evident X But we're I would on soft we'll protocol I'm be these this, fully look that. be working for really of of the to think we'll do that. remodeling. on fulsome really Stein to I position good Dr. And WOMAC and

Swayampakula Ramakanth

last terms strategy, trying me of in question are going for from Europe? on where you we far also the going Japan are expansion commercialization to in get your Europe, regarding and in And how is Okay.

Tim Wright

ahead. Go Yes.

Rohit Kashyap

Yes.

approval First of we the Japan. significant a back all, we're gave access market. us very June, was our Obviously, of in which excited about part got favorable the and opportunity in to

are the reimbursement of process the We in path in through working Japan.

you know, As that steps. various involves

-- middle that and in done we'll effort. of time, market the by that our be XXXX, be will to, We sometime ready with to at expect go

we We launch continue to and treat commissions will MiMedx their build physicians Japan, class the to fully interact amniotic be market the we the products excited and first grow to to of as an the as in our overall with that they're and opportunity as having of look to about helping product exploiting awareness forward patients with product market a to that well. business really for new

Swayampakula Ramakanth

regulatory the I Rohit, label standpoint, it what nature mention can the little from think it approval, you a covers? bit, of a

Rohit Kashyap

It It essentially covers broad a hard-to-heal label. is essentially wounds. all

be as covers meaning So DFU hard as other as and and essentially to it not DFU, just that chronic extremity, can well covers wounds, VLU of lower a broad the classified PU wounds range hear.

that's saying I a to any we by in So than, broader what have access in fact, that it's favorable respect. meant approval what

Tim Wright

to of I than labeling. credit in have It's labeling we negotiating regulatory that that think team we have for actually U.S. the better type some our give

Swayampakula Ramakanth

folks. you, Thanks Thank for taking…

Tim Wright

RK. Thank you,

Operator

proceed Vandermosten Zacks. with line Our of next with Please your questions from the questions. John come

John Vandermosten

accelerate tie cash I flow or Good was to that visibility into was thought. cash coming said into noticing cash R&D R&D trend? will give quarters. below prior that sequentially And you morning, bit free increase operations. a over in us to those see how was positive because let And us flow some Can or levels quarter the improve cash combine expect we nice the can free from flow what It you everyone. in two you the to coming you the trends little

Pete Carlson

cash we about view being it's and that that Sure, spend R&D sort including cord to sort we normal the Pete. a of John, base as flow neutral, business tissue support products. When talk of

challenged To introduce the marketplace couple system. Tim's that products to new have work annually. team doing into So the includes products of really the new products regularly, to in a

about being base have what business R&D in go of our neutral would cash talked normal-ish flow cash pre-enforcement back of the we we that sort then level And revenue, of about again, clinical trials. spend. So we than business do trials generate that help kind discretion And talked support that over that then clinical view Tim into flow. and think, is about, a us for less to X-year are, that the knee those $XX cash the we period. million trial costs cost flow will and the going for that talked I while occur And that's

be in, come have resources we'll the additional costs and cash certainly those that generating the as So we in meantime.

John Vandermosten

Okay. terms of And proportion coming in revenues should the a that certain of in of as normalized quarters? think we a R&D, or amount

Pete Carlson

Yes.

of think you the can somewhere high think revenue. I it to in of mid- single digits

John Vandermosten

Okay.

seems all? only sciences so anything to but that disrupt at issues. transportation seen and it to side anything Have operations Another all lot you on of supply there? gross a question chain I life And those the discussions the expect future space, around like that have, I've able question, not macro margin. maybe in and far from companies avoid it's been kind looking of you've a you at Do more heard in of but

Pete Carlson

overnight again. really. Not Pete it's product We ship literally John, carriers. our using

So we're not dependent on individual or lines anything that. trucking like

to to representatives product, local is our We So it again, directly carriers. overnight quite our with use the either our or customers ability capture strong. get product will

chain X.X in. have working the have we well. issues supply The our of with open -- pandemic from years and really a were We no standpoint, folks including our we ago, team's our been donation not able those network, And either. depths had any coming keep placental there well problem products. of worked product plenty to So and delivering through the

John Vandermosten

Okay.

Pete Carlson

proved true certainly believe we network in be recovery to donor recovery we during the our challenged systems pandemic. but have industry. the it this So, and best donor I

team the side through on with demand the supply managing job good that, on a both So the and side.

John Vandermosten

the When precisely what term, you mean can and or those transportation think be talked that. I think -- I think. like that's does of or things really disruptions? guys that how manifest a about, itself? disruptions, varied, What I mentioned I we including that trial exactly broad are like clinical what some I things pretty they Because enrollment COVID just mean,

Pete Carlson

Yes.

a states large that. where can couple changes Rohit, have We of on there we saw elaborate you in

I on, company that's visits side, disruption you I comments managing the good early a of On any clinical yes, other -- We've that our make with reaching and CRO, we're a there. But on side every to out follow-up to to become -- things the of starting Rohit, commercial ways finding like job feel enrollment that? that. through saw done that neutralized our sure have with the sites, study. trial clinical think

Rohit Kashyap

Sure.

think the happens at itself obviously team point, it disruption wound typically, out access through whether of from in manifests or things: And restriction in there for as clinicians market. your I this the facilities, two care it John, hospitals. be COVID clinics

that the is that thing some product products happens second The procedures elective of delaying our the well. used utilization impacts where get also our of as

delay to access we And to short be That tend Some then of dynamics them it's to hospitals, volume interesting manage will I the our It's the COVID. ability to address. sites with hospitals is quarters. it's several customers can to to to now, the during have that with this think around we even to broader also where reach that scale over our new of care, continue the you sustain next beat helped have staffed go good relationships with and that harder in environment the in relationships and customers. adapt the improve the having our has to procedures and already new more therefore, go to news being have get a care But different alternate nimble those build accordingly. or patients the settings we that across as we easier deal something over with. they At that all through continues to be and level,

John Vandermosten

Okay, Thank color. great. great That's a you.

Operator

Thank you.

Asbahi line Prescience Capital. your from come questions with next questions. Please Our with proceed Point of the Ed

Ed Asbahi

much. Ed very Thank Hello, you me Asbahi.

Tim Wright

Good morning.

Ed Asbahi

Good morning.

Is that enough right? near- for and flow emphasized and It capital intermediate-term informative, Pete thank like been need for As any quite validate generate company the raise. has will or that. you the cash sounded to

Pete Carlson

a capital believe on balance goes ago. Yes. sheet and is Look, raise. said the our we've back We what that to plus we have existing we resources year did

see near-term ask which capital So investors heard a for not do yes, raise, we a about. need we've

Ed Asbahi

the you. than significant into has chance like amount such a zero a patient investors on treated less chance statistically the based scenario, less P the release, thank misassessment assumptions greatly AmnioFix market valued. of Amnio these AmnioFix to is clarity that -- equity capital lot... to separation than these in X% case It mean press separation that due to market necessary, was that that I is to X% and being correct, you. results. Based your that that Thank great think, I cohort the that potential And from the the greatly, a absence between believe a first groups price on were there period, that to Mardin values important a This very yesterday's worst both filing of clarity, that So takes shelf Tim, risk the Okay, is shows of study X-month registration. of because patients and the placebo-treated due over that sounds raise lot, intent

Pete Carlson

Yes, of value. that's the P interpretation a good very

Ed Asbahi

improvement, study, terms to pain And which the of from first cohort in respectively, patients the the That's So XX% of XXX%, treated results -- and the the astounding. improvement from the results of function six months. showed an in quite and after in comparable were CRYSAlDIN any

Pete Carlson

it's Pete. Yes,

quick can Let I'll perspective. give Tim me more and -- you answer a give

those the is do his in improvements IIb. in think We quantitative a different thing metrics consistent, this used it's -- retrospective WOMAC studies. in obviously, metric generally simplest are very wasn't And between a two were Phase the Alden Dr. yes. thing used we study. think I our by The

Dr. Alden So C that the it's and metrics. different used, score those are Tim?

Tim Wright

Patients Look, under it's it's very mentioned other I had this Number for an amount with there. And field. the mean, may this different is broad use is And has of improving the across some same. almost then. a -- the metrics but discretion of the we also the product when Gellhorn a AmnioFix in administered available So There's there, labor, that conversation. partial Bob's tendinopathies, of the underlying broad that has decade. effort on think are results believe are study. They mechanism widely the There's used is that, study. much forms, have mechanism substantial utility spending been team different across action we're of exceptionally with the so reason experiential This important ALDEN that two, understanding you action, AmnioFix EOA, use indications. the many we cares enforcement other product direction

of going that NOA to be that that when down to like done reliable. deploy I the because tremendous this and decade demonstrated But believe need. you and And we're safe obviously, Now a platform do this to the a unmet job after get of on almost bear both appropriate use resources focused technology have clinical there. on has we're

responsibility the You as in trials have registration recognize demonstrate its that agency would to the trial. efficacy well-controlled also a

EOD, with our bearing this December that our there understand And in leadership we I'm developed business. in results company. of we're And plan we've not what really that people important NOA. what what I going exploratory down to after on in under understand happy a of all next. to that and really So are in business deserve. also to analysis MiMedx. the seeing with but on complete with What function the forward we're gone we're out of last to the have going contribute really happened complete do over a it's trial balance is of reviewed on have that. review trials, looking But attitude we through meeting that FDA, now, commercial in our these transformation every the the almost a factors we winning X They with fulsome only to the anomaly. could our Also, Rohit's I'm top has years what's folks our potential and MiMedx X.X performance think not

to on forward X. this December look more So, on

Ed Asbahi

first for -- the from previous reflective that improvements the press first of results cohort, release it Thank That's product light and with that from views of to value in the sounds is great informative Is So these quite from ever this Tim, thanks the in were improvement of results cohort price of sounds And you're very like the I'm study. That's demonstrated even then power profound, color. It you that... have additional potential results in reason not mid-September, through you. light the that following astounding the color. were the hear. on market that III -- you guessing profound. your changed published like a Phase studies the and

Tim Wright

Yes.

and thinking leadership expectations lot this had a our of We with been X.X spoke I been believe decrease when very ability changer. I profound. with But that think yet. done comprehensive. there action is demonstrate is about right you a modify EOD, function, that talking think that value it legs pain, underlying the the this. that under mechanism capability demonstrate able to about remodeling this do that the Bob's improvement believe potential just around characteristic, our of underlying And complete action, a or yes, big talking has platform do felt you ability of we I pain, or -- a about think technology this this the do that points ago that on basic demonstrate a to the we has be -- the to are improvement we're were the in analysis weren't is what, clinic, with of utility, able you our would that of other that not you when We're I has in if We're And game in disease. line it. clinic, in mechanism on years to product. And I have demonstrate in if to in the the have research along

big But that, then able a this are of think we once to need has I area this We of broad utility. unmet do product have demonstrate in to this OA. lot

Ed Asbahi

Yes. we for Tim, a in have publish product. you potential this as present point, And waiver great confidence thesis. on our we market know, That we the is

unchanged. assessment value Our remains of

understand well. unchanged it's So to seems like that it yours important as for us remains

So that or give we sort FDA the Or is simple the, a were. how performance, the results for possibility around explanation path it. the could Is there some there of profound still? you improve profitabilities if that a any cohort some outperformance these still second given the or of the are it waiver or

Tim Wright

to other could the to complete what our be right see of avenues leap, think possibility. analysis, take that is. I is love to excited could discuss see this but product. agency think meet And now, FDA to proven think here I wrong. We we're I I the doing supportive. would to and I be just But wrong. totally will I them very there that that results and with don't for there a the need the that don't be under map

Pete Carlson

more Yes, call. it's Pete. the need have, We there's move one to on you should -- the we the are others question that along to

Ed Asbahi

sure. of Yes, next questions Yes. I'll couple convince Okay. my

or lack based and/or safety hyaluronic available from efficacy. osteoarthritis. of mix patients all So NSAIDs, The corticosteroids terms available real being in our treatment for suffering research, effective the there's of acid and treatments a currently or of on treatments deficient

is known So a this -- and fact.

for a it safety even amines profile if effective that lack moderate AmnioFix and be given the drug? blockbuster contactable of true neocearthritis, demonstrates injectable AmnioFix then could injectable isn't So options treatment efficacy,

Tim Wright

lot are Let me a alternatives there. address of way. this it There out

a than and is this there -- what believe that we're suffering so would say, treatment to this it's is shift XX prolonged here, use. out people Part biologic how important. underlying and characteristic, in them. in build and I've to -- What's of do due been you complete understand important their I -- the that product demode efficacy clinic, actually chemistry a, I You've alternatives that represent the limitations. paradigm and these this action different the have really is million for listed why of manufacturing a this And you stressing efficacy, osteoarthritis of mechanism as drug what if is of profile know, works. from think understanding the would able controls, are All safety it their with I drug safety demonstrate it's to today. available degenerative who be drug there Part extended This is the disease. how is the is the if around

we're future. that a different provide could the treatment believe type, different do this optimistic of I type So, that useful completely in

to to able it to that scale to to demand. the got We meet we get we of and have and prove have type clinic, be that in our operations approved,

Operator

Thank you.

Our your with question. next Please questions come line of Conway from proceed [ph]. the Bruce

Unidentified Analyst

embellish If to studies seems Pete. can pleased there score that shed maybe and were to the you. for I'm little bit Tim were on they on this to business. on glad Is morning, figured up. wanted those you I'm WOMAC that the out be it I Gel would in also and the scoring a really brought the that attributes company. both harm very see differently, to very your scoring Olin to believe reveal the emphasis is heard light And AWC of the biopharma I III. Good positive. growth right, me you but studies. a it I Phase scored the both the a Thank hear big

Tim Wright

very seeing is to all contemporary reporting to the us clinically measurement down clinicians their talk trials, function, retrospective, all these WOMAC in benefit our and is function exploratory sit really thing area. this the and they pain the scores. whether I scores important in And what most I probably Well, WOMAC the whether from their are it's total payment you if and it's similar way the the think subject demonstrated particular meaningful is in scores. don't most Bruce, -- discount prospective, WOMAC have [X:XX:XX] is to the we're is in What [X:XX:XX] are patient. the what frankly, score were

an endpoint important to disease modification. either capture around point is The have secondary an other be be secondary that it. that on able a to X-ray do we're is would that could MRI piece if or do And able we end really this and

characteristic. to of ourselves and and disease-modifying trials. truly this, our that we that we we in is clinical conclusion on owe come all to believe frankly, need the that a think truly stakeholders -- this believe we to beautiful We if to challenge our and I demonstrate owe patients Bruce, to there

Unidentified Analyst

with those or the from and suggest second that images the problem leg. would me Yes. obviously, to And be placebo, differentiate as you seems certainly say to

Tim Wright

done make our I The team -- I going rebuild that's one your shift thing to frankly. There to that entire you question, brought and fantastic on. up think here would I the capture a sure is had commercial organization, We've job. a we in want has that

you've business. Care Bruce, you And pioneered Wound in a It advanced this the The that know, time. stock company was as mentioned whole area. brilliant. long been You absolutely

was understand we're thing bigger company that That's utility musculoskeletal and there why the studying was The did EOA. why the other That's more historically, disease. we're in indications.

company. we we in AWC. more that have area taking. are technology, what biopharma. biotech studying you're It's we I'd a broad bit company for on feel antibody But came this recovery. But we When than more with thing been cancer. biologics way in a that's and to is a molecule mentioned wound biologic, different company. that small Well, than last because we're on began a platform board a It's it's that tissue that's than dealing other that surgical And but for nonsteroidal a working other just year, it's it's care The it like can on maybe utility touch has penetrate. than wasn't a way. always Rohit in was an this Rohit different is more got also this areas -- The company like company characterized you

to scientifically otherwise. intend be a needs think So this we and is leader, a whole new that leader category I and that

Rohit, please? our surgical So talk you recovery, could efforts in just about

Rohit Kashyap

Sure.

at these those clinical situations clinicals that the to desire over to last amniotic because support sales we bit our you complications. either the have situations value in a more but issue to reduce help graphs a different decade this and tissue surgical clinicians then little light the closure the different a those the can procedures in provided bringing share and has definitely drive learned In streams lot now augment and barrier two use do. well. troughing than situations. getting the on clinical market also million As grafts Investor complications Day, we'll be so. also And that what the setting, of developing to with of or provide these this reduce they trained, penetration used the both as that to in evidence do the we or direct and our have agency more the in our on And procedures continue focusing is and clinical to focus that on And folks know, process,

Tim Wright

way we molecular It's head research I our lot built person our Another with up of is on level. and well-known on around activity product research, there business the programs to we at a is our designed mechanism going base brought more think. what's all space of to in development a development. this historically, the Harper, cellular action, We focused that John product aspect, organization forward. these R&D going The our on Bruce, The piece a the crafted a we've in designed support of that. this

-- and sales out So organization products as challenged -- infrastructure that's under we I've John our and there. early in the cost we'll provide Pete Bob's to get have really of put mentioned on, more that leverage of sitting leadership bag the our reps,

-- that's support feel you -- opportunity that perform I to working exponential future, run led this able have for we'll our we to very in is will if And growth the musculoskeletal Dave company the out confident be and our of Mason. then, group, on area, clinical for organic this R&D, So base another supporting operations by rheumatologists business. company. through

working. the think entire the working way starting whole business, now should it it for I So we're business we've at as look got -- the I be

Operator

at remarks. closing the no to for to questions There are you. Wright time. Thank any back this I Tim turn over call would like further

Tim Wright

quickly Look, here. I'll close

what board. I'm We here very trial. PF the to of continue pleased we'll across business. on do the R&D we've trial have commercial frankly, we and the to value with necessary evaluating pleased performance DOA the capital in to [ph] need And very the do responded how our with I'm

So I'm at discussion continued with really on Much X our you looking your Investor robust for Thank for a MiMedx. management team in my December very support MiMedx appreciated. forward along interest Day. and

Operator

today's you Thank This participation. your for teleconference. does conclude

disconnect lines at time. You your may this

MiMedx (MDXG) 3 Nov 212021 Q3 Earnings call transcript