MDXG - Earnings call transcript Q4 2020

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the MiMedx Fourth Quarter 2020 Operating and Financial Results Conference Call. At this time, all participant lines are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I would now like to hand the conference over to your speaker today, Jack Howarth. you. Thank sir. ahead, go Please

Jack Howarth

are financial you, and Operator, MiMedx Tim and results Welcome the Kashyap, President of Carlson, today's morning, results Chief Tim Financial and Research Officer, Dr. Commercial and the at of & and Stein. Pete quarter questions. will and Officer, Stein of Robert good Pete summary call and will and on fourth available Vice me Kashyap and Executive operating Vice operating their quarter call. everyone. for Executive full Dr. and for fourth Officer, XXXX, conference Pete, Wright, full President your a to Executive With provide Thank Chief Chief Development, Dr. be year financial remarks, Rohit year XXXX Tim, conclusion the Dr.

release, remind Before that in measures, we we include provide you reconciliation non-GAAP comments forward-looking our today Also, comments will our made press is like I GAAP financial would call include website at and which statements. begin, to www.mimedx.com. available on to today's our

set required the no now With materially update law. actual I'm to forward-looking those supplement that pleased differ company Annual anticipated the to outcomes subject obligation yesterday, the the and XXXX Wright. reflected Form Tim? to over and the in many MiMedx assumes Tim release except risks well Listeners in are that, to press reflected and forward-looking statements forward-looking in differ The believes issued those statements, or could as are for assumptions, Report based on from results the to company Although, the turn to as any uncertainties, statements. are outcomes directed and that call actual materially forth by such Factors XX-K results from upon may reasonable expectations factors. Risk to due cautionary factors notes cause as in

Tim Wright

was in to a transformation, pipeline us. foundational thank on morning, forward of initiatives its MiMedx. company Thank and We focused the you number year everyone, a momentum. order Good for more move and its regain financial you, for XXXX propel joining in Jack. and operational

Before let of last initiatives, from strategic some into I me accomplishments many the year. get XXXX review

talk We’ve about our of senior our experienced leaders the with high First, restore XX% matter and business period. the converted let in efforts during accomplishments the board. to management recruited me subject this expertise across there. We've executive integrity

stage honors. therapy, combined of national has expertise, and existing and and perspective will board in biology published extensive conducted therapeutics. late reporting. financial on and into of pipeline to future across towards We Gardner the The our guide joining also and academia, School announce, also medicine focusing did expertise. company, is brings more Medicine, Stanford fantastic governance, marked numerous healthcare the Dr. We're and on to University a of diversity our than experience for board, pleased is board. regarded her of the industry. is Gardner Phyllis of be propel cell research biology and Her and job She contributions strategic regenerative current reconstituting our improved Gardner to biologic Dr. professor business distinguished leader. at our a by the biotechnology fields of and business invaluable, the as She insight our as Dr. XX-years a with accomplishments we awards pharmacology. widely getting with restore registration, in cell gene start efforts MiMedx

X. EW $XXX important led NASDAQ is In business through Also, million capital, the by of November Healthcare. aspect financing relisting on a needed addition, we’ve raised on an restoring

with Plantar Xb enrolment We of the our study. business the capacity, potential In expanded X which Knee of completed to Fasciitis boom business, the in Epicord Expandable. creating and restoring shareholders, patients our capability out we launched franchise This product completed provide and enrolment. called value study, Epicord long-term for economically. Phase we In coverage addition value OA new offers a physicians Phase a to

largest of in begin we're from a addition, accomplished, foot coverage in. ulcer that commercial really U.S. and business year. diabetic the payor and proud aspects everything I'm to EpiFix the in we’ve we a investing focusing position U.S. received operating now of In the on busy, XXXX busy our was

our using We shareholders. will pipeline we care as are for our our extraordinary the regenerative pioneers believe in business a birth platform biologics create for tissue medicine. value And wound in advanced

regenerative care Our of access over doing late products, by is our novel of we so, will accelerate pipeline by goal number primary And improve utilization and our stage one. top-line XX%. wound twofold, medicine. a grow two; Number

company, giving objectives those growth addition in will the of another and our EpiFix order presents care for growth These wound times our have reinvested to This in anticipate Japan. We're registration force core very pipeline attractive We so in are sales that, to impressive get reorganized, by about me we exciting momentum overview the of you we support let for assets. our support for mid-year, In business. two primary also completing confident process registration two XXXX. started for to reincentivized receive and approval very very, opportunity an MiMedx. capture

Fasciitis. opportunity Plantar pipeline First, is

As study control was pain Phase and in completed Xb our demonstrated versus reduction at three know, months. you XX%

of study, XXX Now, which our enrolment we've completed patients September of XXXX. included X Phase in

is anticipated patient out QX, to be XXXX. Our last

our you on XXXX. give of on anticipate BLA the We filing in first-half estimates our BLA Let filing. me

we XXXX. first-half to product we our has later anticipate application, for when plans plantar in before quarter have accelerate We quarter. file late of on earliest market also that, the calls. and launch the if approval articulated XXXX, FDA would been fourth fasciitis some fourth submit of The at our or We will the in predicated and be all of possible,

these fasciitis for product It's lengthy tends recalcitrant an plantar is for in believe therapies that year, injection About XX,XXX chronic a and patient Just the AmnioFix note be patients treated potential patients. in of setting. patients be PF. We to million first advanced from will X reminder, candidates of our approximately recurrence are to XX,XXX annually about the as require are to like corticosteroids. XX% common very those important recovery and

osteoarthritis. pipeline is second Our opportunity a knee

our significant Xb trial a need. very enrolment as you We Phase completed know, this well. unmet our is As in September in all

me our you trial. are Phase are 'XX filing a means to mid-XX, patients, be month having to the afforded blinded Let cetera, the that a trials, company Phase second-half agency. the dHACM that Obviously, that's we company we will or again of XXXX, to trial note presenting to late we reviewing to XXXX, of of readiness, it sooner. Xb as month open filing or Xb first from designation. that Included the initiate six in first-half of X the of extension process our receive six with approval, a the surrogate What's enrolled also allows last large follows. This received as observation advantaged the XXXX. clinical The FDA assets discuss trial, PF, 'XX. that two out AmnioFix. endpoints, in the that is to fasciitis the RMAT our with by One, care also that protocol. This in be by then The BLA the allows or around we important remind will was trial we'll that have frequent our pipeline PF. don't manufacturing not opportunity et meeting option market in go our by for the second-half advantages dialogue patient us through the is registration. as and be in We micronized Phase FDA GMP And the you would anticipate this enabling Phase label know, current first-half here, we're timeline anticipate is criteria. several if there patients the plan X plantar filing our to factors Also, by process trial afforded would protocols, XXX first-half be release XXXX.

offer think, our So, value who both to value are more these exciting from potential create shareholders, particular pipeline for this issues. patients company opportunities, for importantly suffering we

labelling be market very, million patients math with on X% to you would we we you penetrate annually, around a off know X.X treated X.X are how treat large. Phase think osteoarthritis. market. we around patients. injections, efficacy a very at the -- Today, new the treat of If will for million annual million trial, this be growing physicians about million we year. and is think It's would Knee tool commercial our are what OA We we basis. about That this intra-articular X.X per an Shifting look our there When the X As what X being very organization. patients. XX.X injections important in on this based year very, million and of do to base the our proven to is

DFUs are to them reincentivized our As earlier, areas and I the promotion, that distinct organization, we for of VLUs. products with redesigned have on mentioned focus used

expanding science liaison infrastructure evidence Importantly, million cover we robust very program, medical a XXX we an that reimbursement. lives. clinical and over Today, have supported improve commercial is by

IDNs. So, in contracts the through we place pull GPOs with efforts to contractually multiyear to products, to and provide have have our currently support access largest our and

and teams on our initiatives, products. to as used our Our be account the which accelerate focus focus our field-based summarized national strategic pipeline, core can our on off covered reimbursement also I've commercial are of adoption business.

turn Pete over going I'm to, to Now Carlson. the call

Pete Carlson

seeing some year good our Thank will full I and everyone. Today, comment we and morning, are of and underlying the in business. on discuss you, trends the quarter Tim, fourth results XXXX

you reiterate If in want take moment and accomplished XXXX. some of MiMedx achievements a to the

acute a are engineered our treatment families. wounds. financial us continued PURION for delivery that hard-to-heal Many can make chronic that to a lives as and support the our and reason difference have of patients seen to their advanced working we company, of have, products in the the impact an the restore options is As technology reputation of

elevating in All of our care. platform talked Our dedicated commercial not quality And team's the in products growth. about, the late increasing organizations are investments Recent as we core our market the XXXX, advanced we coming standard we amniotic have growth wound this to the position us are of for is In to positioned differentiated excellence pipeline. believe same, both and level in are and I and business, parts commitment deserve. customers exceed portfolio tissue the our delivering to our our XXX plus efforts appreciate our employees care of stage year. our patient

XXXX aligning increase quarterly by on places. treatment EpiFix, U.S. to the is personnel through flagship a behind our I sales would by results, to with have are in is recent brand, that recognition the team along or transition proven company's for to the payor plan number in medical with largest our coverage for We results XXX ensure option of XXXX territories XX% note education commercial as diabetic people We're leveraging the The right and pull we Returning foot that more, right and strong, help efforts and personnel the revenue medically ulcers. methodology necessary to also and now this us. increasing customers. impact our

care implemented procedures, and at much XXXX.This this fourth to decrease decline our basis. recognition of and umbilical can our flat elective for which compared XXXX, methodology. million, Adjusted and be are XX% of of the same sales the recognized resulting is XXXX, want were the clarify XXXX ended include the an reflects in trends, of wound decreases for a million, seen on hospitals business, revenue in compared net $XX.X to XXXX cost change results. tissue less in part of a million XXXX. received to as respectively, pandemic. for compared net do breakdown $XXX.X were in by reported year million a on recognized $XXX.X sales benefit sales, for impacts I primarily million period a Net full And XXXX. revenue the from reported XXXX Net skin the substitute exclude December company's $X.X impact COVID-XX adjusted However, This in transition from the to looking basis, of $XXX recognition access and decrease measures XXXX result our product, our also in sales quarterly full quarter cash advanced in as-shipped XX, the year primarily saving the cord restrictions, on primarily

are of of scrap. fourth quarter was of lower the in XXXX, period in margin the up down reflecting approvals improved fourth net slightly the efficiencies fourth sales tissue and compared of XX.X% Gross the XX.X% Excluding to slightly, of while in products of quarter XXXX, period. in adjusted are out impact levels XXXX manufacturing that cord our and quarter umbilical

second-half and For of the XX.X% standards have a general practices, to quarter. of implementing stock-based the fourth been the saw or were compared and to gross XXXX this full decline of year primarily a corporate initiatives the good XXXX, compensation we since administrative XXXX. expenses slight or Spending fourth in XXXX X.X% XX.X% quarter from increase on SG&A to we quarter of in current result XXXX. million, the of increase the for an XXXX, Selling, higher contributed manufacturing margin $XX.X for of quality non-executive

in the manage For year, SG&A, in decrease the COVID-XX to expenses pandemic. in part full response to we by driven company’s saw efforts the a

As including temporary salary travel implemented a previously and number we restrictions. of disclosed, initiatives a reduction

reduced to a quarter from the of $X.X commissions in also reduction year were development to $X.X the of addition, decrease. for the resulting Research expenses fourth compared XXXX, XXXX. sales contributed for million million and In quarter fourth full

these efforts as the expects this to million year. compared much expenses research Consulting in development For the coming costs prior the $XX.X drove clinical to research in our were the full $XX.X three-fold related The as year, increase. million and fees company XXXX, in increase to company’s year.

this We growth our the second outlined, the objectives the vary of readouts future scientific the in drugs depending although study research our this Tim and first-half license of including mentioned, year that quarter Investigation, year, indemnification consisting economic the agreements resolution of plan of and related these continue results investigational period, publish management for fourth previously file $XX.X totaled involving filing clinical amount the cost previously expenses. incurred our data. supports in could the related new year. and former investment additional to of further or applications, quarter clinical new legal the and I’ve and As of biologic million In the were on towards directors, company’s including the and indicated. million, restatement consisted $XX.X efficacy of of to certain as with expenses ago legal restatement and and matters costs some under matters company, working XXXX

XXXX, were expenses, prior company million the $XX.X a $XX.X XXXX, to expects in investigation, any the decline of related resolution restatement compared to related matter. pending full In in and investigation, expenses significant year securities action class For restatement the million XXXX. and

those matters restatement Of course, Note We and on Audit the XXXX was we XX-K. not because disclosed actual the outcome the forward. results was it against I judgments of now mid-XXXX, part may we obligations. these conviction related former company’s that you the indemnification not incurring legal expenses has Committee for are expenses in certain incur the off CEO mid-XXXX. remind completed and currently completed COO, as entered do and going dependent is Further, advancement the vary investigation and in that of our stand, they judgments expect of and to our been indemnification position individuals, cut Form advancement XX in and

year reflecting was fourth million from full $XX.X of the $XX.X already EBITDA benefit the in adjusted recognition. change was the sales. period, term on In including from company’s of prior million million in debt to or year full in the net $XX.X loss net net revenue Adjusted year $X.X $X.X have includes XX.X% million, in was the well quarter $X.X as million, of Net to million discussed. of factors revenue to fourth a $XX.X fourth adjusted $XX.X recognition. line, of loss million The benefit XXXX. compared million XX.X% loss XXXX, XXXX of the in previous and for of bottom fourth $XX.X prior was sales, the $XX.X of for loss the Net the XXXX. Turning quarter compared million loan, million change EBITDA the a quarter year $XX.X an to million the extinguishment the XXXX adjusted of I was net for quarter loss or a compared as

position. Now, cash let review me our

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

flexibility our development Our in strengthen outlined position and I us and core healthy earlier. as gives the invest business, cash financial to invest initiatives research that activities, in

as sell we are Turning we materially, we actual over net our micronized year. to for $XX able negative the caveats, there assuming full will our Again, prior million. some sales differ million and range XX% our estimate have period more are the results could expect may we as the XXXX, our increase on umbilical adjusted cord year, particulate micronized, or impact to net to to products may and be and particulate of products following market, the from be to sales of XXXX the Specific expected example, if removed discretion, are required these indicated. products an in $XX enforcement the

full and As clarity with enforcement timing we additional gain Tim expect of on our the and mentioned, discretion months. FDA the the continues, in dialogue coming impact to

by ulcer reasoning discretion. You the other products our primarily standard for foot outside to included micronized homologous the impacted the within viewed discussion focuses utilized. are will which diabetic FDA and of marketed. enforcement on products the the products and minimally more their of areas, than note number products, products, use end have cord the could The are we based as cord where disclosure of and particulate those period some and and described here be which is the venous that communications cord leg different umbilical analysis these than our are is way are limited ulcer umbilical a currently potentially products products the on manipulated. The that marketing companies This selling from of of

the We business, achieve to to including key new targeting portfolio, innovation and data, business clarification are keep value expansion. pursuing and FDA our we additional core guidance, with working and the the of recent international of presentations, enhancing updated. in awareness drivers expanding gain market outlined potential have you within product growth we'll the impact our through Throughout

we still regional and surges that our have midst and know efforts positioned outreach While without the the certain chronic areas, of are non-healing COVID-XX as we pandemic, I are do and needs growth We with of in dialogue getting treatment, that optimistic investors potential, or closing, XXXX we patient continued. in better population. you about of this are and you commercial local wounds team remind the our continuing to not expect, In is are address analysts. other our

NASDAQ our of members will to community. story benefit call have our in industry Tim. Another back the I continue to sharing participate the opportunity turn financial of and to chance is increased with the listing conferences, now the we enjoyed

Tim Wright

Pete. Thank you,

drivers and forward, is on our in growth R&D, Looking focus our the They're commercial. broken XXXX. for down company for operations

the We pipeline, those. of review quickly accelerate Phase the application accelerate year of do readout, just clinical trial late filing me year. example, OA, X the our On for the an our quarter. data plan accelerate our stage the fourth into second-half Let first-half interim PF of to into the Knee

our oriented have affairs We a to and scientifically on effort R&D, medical organization position articles continue peer clinically to are review economics. an oriented, through in ongoing that publish having

we this XXXXas well, patients. for difference Additionally, file of a continue support to to INDs company new of goal category, scientific achieve in significant to to some makes that way advancing rigor in plan its the

Moving to our we from facilities standard. practice good operations, validate manufacturing to R&D a manufacturing plan current to

our our year-end. XX%. our XX%, addition, We're of we to approval that by continue force sales speaking, will top-line reimbursement rate midyear efforts by Japanese high grow our receive in as above affairs. we'll medical plan Commercially and products In by well, for augmented we fulfilment approval by XX% our hopeful

to organic R&D Additionally, evaluate development we'll inside and opportunities product growth continue our organizations.

we're in see for investing and growth. Pete's you presentation expanded business as mine, core Finally, the from can

for a today. on listening lines if In addition, now questions. laser-like-focus open thank to Thank Operator, our accelerating you like up pipeline. have the can you for we you. I'd

Operator

H.C. Thank question Sean comes [Operator first from Instructions] And Kang our with Wainwright. you.

now open. is Your line

Sean Kang

for Hi. my Thanks taking questions.

year first allow FDA how micronized the your product XXXX? you confident to question continue marketing for are my is, that might full So you

Tim Wright

to the going that. exactly is clinical well think Hey, a a this the facility as that This over is anticipate I to industry the our as XX-months, Sean, GMP, I in that asking is we've great in line had on doing about of them, continue down FDA that's convert INDs. well hard And to to agency we're ball with Tim. do. is where fall trials, don't last with everything have crystal communication conduct manufacturing to as however, new as file perfectly the to It's question. what

Sean Kang

to much I the are for you see. how XXXX? of And your vaccination what getting things also, with pandemic hopefully Obviously, expect plan is risk? program. like mitigate like, a And better potential impact do

Pete Carlson

Carlson. Pete it's Sean,

about haven't any merits or what's the We quarter expectations or specifics going to a given one relative on. way about first what's other new the

the technical, ago. my saw impact. everybody incidence more that year diabetes. the very then it's and XX-months And there It's in did given lost Texas term what remarks, some mentioned be that's some I thing, knows year and isolated in is little ago, And other experiment regional in local has what continue is those was a ones, I ago. again, used we from or Texas. have As of the populous high bit a a months free think, we does earlier to about a XX-XX But talked we but a certainly mixed haven't specifics. I than there of was state high we any time whether, otherwise, not

Sean Kang

good. one. that's One last quick Okay,

if apologize year? there from earlier. I during this missed is missed products pipeline that. Maybe this I call data So, for the any But the readouts I

Pete Carlson

the There musculoskeletal on on trials It's first-half Pete, area. calendar Stein, really we give readouts year have Dr. Dr. all in the three of in. he Yes. I'll fill again. coming Stein? the you in and are of can the some going just

Robert Stein

Pete. Hi. Yes,

completing the So year data first-half and the be as for fasciitis, will of plantar in patient for analyzing will last tendonitis of a quarter. Xs said, out about this and Achilles we Pete be Phase our the probably processing

program rapidly we FDA other as six as can. in requires. will two, outcomes. And will be are Phase will We a be the Phase and forward that's time, Xs the month moving And forward to still patient same the we'll completed X, meet trial, the have six Knee time, appropriate want the at the At able the OA period. observation last to much results, as complete, FDA that those open we'll have then extension the to very looking describe that the and the with month we label blinded

discussing may we have You with FDA. for that be designation we product. remember the RMAT results will the And

interfere However, though, that results towards and with time the the regulatory to so opportunity progress don't our to our public registration. they product description successfully of the path

data we'll as So to cases, interactions. the share regulatory prudent soon in as so regard all do with it's to

Sean Kang

Thank you. thank you. helpful. very That's Okay,

Robert Stein

Sure.

Operator

you. Thank

John question Zacks. comes Sci with from next Vandermosten Our

Your line now open. is

John Vandermosten

Good morning, discretion. everyone. It had on sounds enforcement has the like FDA only limited communication

this? So, to to public that out how maybe I Or think as might Would out they with obviously, positions to be it will that out wanted there closer going will you kind perspective of but they're May we there. Can to look given see conversations doing of company go And end how for from some get to specific reach that companies industry? could address different you company aren't. them studies some it and And be there's you them? reach some or obviously, time are be me? announcement specific, period? Or at not, will on the

Tim Wright

We've XX-months. Tim. with about how Stein I frequent issue. thoughtful dialogue opine that agency over being as is believe address the on had last is can they This agency very Dr. the well. fairly particular this the this

in which more trials, number any of in limited to the in support efforts what while provided some there are feel can you and guidance engaged to agency with stated any from letter. conducting clinical be the we XXXX. As guidance in have would that are you companies a trials, I filing not do are comments, additional in conducting line their implement comments? done confident, actively their INDs companies Bob, XXXX agency your everything do their we've that

Robert Stein

in safe able after are we've some regulatory what for trials XXX donor. hard our derived are they cases tissues Tim think be used of demonstrate as very regulations, in for can looking moved and to effective, in that the pursuing get the that more that are being Knee product than I are And our minimally a the get the engaged FDA did interactions therapy, that are than And in through filing and/or we'll dialogues directed regenerative them the successful medicine that that that in believe other some we that INDs agents which interest are we making transition is we to products summarized appropriately making specify. designation cGMP, do other upcoming better the used constructive the indications And RMAT covered conditions that trying well. for. it in FDA into under We we've oversight support or with manipulated interaction we'll when be from got their under that is to IDEs. the or through agency. the believe with We either the worked the to the for advanced company clinical FDA, something fortunately products OA

John Vandermosten

go Okay. I'm ahead. sorry,

Tim Wright

please. just Sorry, I was Go ahead, Bob. thanking,

John Vandermosten

anticipate that hold will another Will the on guess, happens may same Or ended? and just going discretion is you And back? Or able how do forward? be -- you I question that What topic. you to it that to used? product in be channel if anticipate enforcement

Tim Wright

the in a Clearly, FDA to our The safety American on to around central that what public. the there's FDA pharmacovigilance of provided as think database safety. And has not is strong record us. the perspective role about any track you own

So, I our would let scenarios But, expires, with be how enforcement discretion would think be roles. or at would looked way I the that and just your way speculating to that either view FDA to we really respect we're obviously the I question, different say other prepared speculating way we've would that. one

John Vandermosten

done other of to up to it's well? at there. almost be I to that and to the cGMP the is remains the get compliant as mentioned, Okay, the What one was What think great. standard And facilities done be remains is cGMP as Marietta facility?

Pete Carlson

Pete. its John,

seeing want may Tim FDA. and from comment the me Let response add. the to there you're is What just

We the both time. remediation the have at facilities at same approached efforts

completed middle to to a have one in FDA, frankly, what to at really response the we the XXXX has was And of time. felt just respond chosen So facilities like findings. submitted a out of we report the

nothing Tim, to response think… So don't from relative I to else to be our that. done side,

Tim Wright

covered it think I off you well.

first-half audit. I the so is of XXXX, We the have XXXX effort agency any with the a address deficiencies -- past to we far. in were noted December think significant for our response And over the that made pleased

John Vandermosten

part And growth include health them and put -- Okay. payor plans commercial you've included board, on the commercial MiMedx. of of already a with and largest plans getting the the big them payors on

the additional to trend able what others you So in that the are obviously, is largest this in category? big penetrate pretty are cap. your efforts having add to And payor leverage on feather targets? you continue to a And these making to

Pete Carlson

again. John, its Pete

start. me Let

payor, largest the we’ve and that all the commercial the with addition indication really coverage Medicare system. have of with With payors obviously Medicaid commercial some

about it getting So those more now indications inside that’s additional evidence. perspective, clinical and payors is

So comment Tim on I'll and/or Bob, let that.

Tim Wright

Bob basis clinical come Certainly, economic the the think the Bob, can I peer our done you we've comment impact of reviewed do that that at evidence well work as health evidence, that on want as we're to to retrospective generating, on products. on more? the that in. look

Robert Stein

upon with for retrospective million able Medicare the record sheet various for to their be believe of an the over diabetic evidence utility described some all fasciitis have patients, introduction. of a would And programs of the an performance. been life products we the those been for of patients products the clean products. an the And record the our probably, superior ahead safety very conducting data XXX,XXX the we trials I Yes, do including difficult ulcer safety been ulcer. bit basis products since of the have in And call. are control of randomized and to also that amnion/chorion stage is that We've we've there perform. And And function world we are competitor like of terms excessively to work current in in the as, the the how sheet we've use plantar real in distributed than interventions. to for advanced interesting sheet lots XXX of foot knee settings X value in nicely to interesting shown on database already micronized our utility circumstance foot have in in gather comparisons the demonstrate some osteoarthritis, later have thousands And clinical and we more track of in cost the earlier they some products, additional Kingdom of in many demonstrate products that such ulcer, they conjunction in in the which just and little have the number studies in membrane years, determine. to the quite for and we and and United curve the diabetic continuing how exceptional in work addition, patients, more that they have products trials, quality about analysis

John Vandermosten

ammunition It like a for penetration. you’ve sounds got further go to yourself of Okay. there lot use, out get and to

was people in XX that reps, you’re So adding year. maybe I also the XX think to XX% sales over next

over together include I all about overall kind does reps there about well? So talk some guess come there you’re that Or growth XX% of adding you sales these top-line, rep And that next when sales how growth individual just the new as year? is on? in

Tim Wright

like address you to would the question? Rohit,

Rohit Kashyap

in factor fully Obviously, as force But we Yes. and Tim. be sales sales take come anywhere scale on it. a come of factors I on XX-months six between Yes, will team to will driving of the Thanks board. there typically effectiveness. add effective. the it for and are growth, Growth sales increase people think multiple is to terms people board

clinical combination growth in we that more treatment, growing support sales the new for the the both of a informed of the of is are addition data the that the way the people different with the talked options about as So, a as it team and them to existing headcount. well sales utilizing getting available above of evidence, or market with market the with just the

lead multiple that market are above factors achieving up to growth. and XX% above there So,

John Vandermosten

your confers, get Just to be And helpful. of and perhaps what of you’ve the such available jumping generated approach very data with right perhaps studies That’s indication, talk plate you’ve is expedite a some that company of on hear maybe have like seems Okay. for extension you’re that on take with benefits RMAT then to as RMAT to estimates opportunities designation. that hypothetical the treatment doesn’t that. the It you perhaps very advantage want now that some really that conservative or KOA benefits that done? what are that it of the about designation Can to some that might possible already you an the your providing approved or grant the now?

Tim Wright

All advantage that probably more think like the know dialog achieving Yes, And XX correct. the as frequent senior I protocol said, we’re clinical biologic one luxury there and first management think on, RMAT the And your in products that. a to knee this I we’re it’s prior management than our you preparing areas trial important team osteoarthritis. have It do less trials. are is, very for as dialog you designation. number The absolutely X know sure. have for are you’re agency that the afford you does with received RMAT des, successful was two here Phase the and at to probably with of of taking FDA very

very our in trial, trial. the Phase We on Alden it's the think retrospective a good of the status articulate data. The can. produce data conducted can around think And creating with very if our focused important ones clinical chemistry currency but I that Dr. area. All manufacturing And working agency manufacturing control, only we to team We particularly we’d Xb Stein what that the Phase Phase that not important so RMAT dialog with another on X be I the data that’s in will and that’s in also our with replicate exercise And trial the agency. for to trial FDA best the think more. is definitely Xb that be data data that’s shape aligned is we is conducted, his results the in agency I large area we there. in is the our Dr.

doesn’t streamline making that Bob, trials. around manufacturing more It’s standard you enabling around approvals. clinical would just you the you manufacturing, release so product to and please? frequent FDAs your to decision Now, process have can subordinate dialog, RMAT like to add

Robert Stein

I think very said well. it you

more have I regulatory the they progressing an that interested think that collaborative the indicates is way a and the designation medicine, somewhat of believes process. indication that through RMAT product a potentially FDA important in are the you

were we're And based that get. where designation on have to FDA. the that. point It's to glad is very the not presented easy the exciting so it with the data And until discussion up I an think was held

John Vandermosten

INDs question for just Okay, on new to Last be me great. year. that going the filing this you're is

be some wound in what and indications are the think that care. more a Can solve of into pursuing be detail there exciting bit successful? go you they're little may on to you'll these I able advanced he if

Tim Wright

Yes, Bob?

Robert Stein

about to be I'd give happy you of that. bit a little information

be the where material sometimes injectable micronized use used outpatient have you non-healing the have in patients products it's or reasons. effective, other compliance either for wounds, for We chronic with sheet often can't fully

to are known support healing So filing heal. micronized malnourished there. edges around helping And having likelihood cells use to that often to a patients of material, we're lower interested also or foot the older be ulcer, and have stem process employed application. healing to incisions or diabetic or to going in material are either an we're surgical IND the the drive of after there's smokers in Many it's micronized then, And or looking the at and the successful injecting incisions. recruit surgical who of help diabetic obese surgical interest being

particle that that application And either pilonidal matrix or cysts the factors. to that have and under often be use where or exploring soft well. called what you that's extracellular used is other or in and And wounds things amputations and we'll fill be want settings as And growth traumatic a operating tissue tissue size, so you investigational does. defects put And that in something room, there's then provides in like missing the in AmnioFill that. material the setting we're to AmnioFill, to larger is exploring going

John Vandermosten

Great. guys. you, Thank

Tim Wright

Thank you, John. John. Take care,

Operator

Instructions] you. [Operator And Point. from question Eiad next with Asbahi comes Thank Prescience

Your now line open. is

Eiad Asbahi

question for and Bob. my taking for Tim Thanks question, is guys. This

elaborate of OA, you Just saying to that sounds from the modeling at HA. capture X positioning, Is AmnioFix to million be knees this sense talk or of three thinking per standpoint, from patient Knee per more make a in to of those in backing I've of both patients, previous each alternative of heard likely we light up about to four like patient. How of as shots X.X in such conceivable? patient you OA year? looking pipeline it and Knee in in on Are potentially, benefits, patients Can are year guys patient that? how shots competitive some many you're than relative per conferences corticosteroids which about per million its seems kind per you thinking and we modeling about the its and profile terms per out? it with its thinking not of has shots guys guys safety should place treatments potential taking terms NSAIDs,

Tim Wright

patient the let they I'll knee another about having question Bob there To It's answer just a injection viewpoint. it knee our Tim, in initial X talk into patients ideas That one directly, is was as them realistic. is other to per dialed This when the other assumption. patient. that's of from certainly decide calculus. with if progresses one treated is to will. his treat The treatment you X.X But the bilateral the idea injection your

to advisory we're we talked our research, opinion As perspective starting primary we and on leaders, change do to our key more that. board

between period So, a patient XX-month and receive four the throughout year one for could injections. a

So, lifecycle are of disease. very, degenerative the on it'd very patient be where they dependent their depending in

probability know I other knee knee, eventually in think a have get high it you your we do away you in that that one there's will knee. once

physician Bob? on wants begin So, the patient. to it how treat that to depends

Robert Stein

rapidly. Once the up makes take other And good you're you you other knee, some the that bilateral Eiad, knee, more you knee put that right with the and on off to start absolutely bad patients weight have made degenerate more osteoarthritis. points. end that Tim one many knee weight think I

not knees come two it's it's become pretty time. But case affected. the the may that as that uncommon same so not the And both at often knees affected

to some the one that it's be patients second many going administering to And our be think patients current to so will are the reasonable bilateral injection. exploring after X we're Phase believe effect injection, injection. we and In duration I study, getting of

of year, continuing we're a unreasonable of like don't to a times we'll twice be three evaluate year, to that. the that. it's but actually So, a probably could I be think might that injection now. have better sense believe And frequency right looks twice

didn't medicine think actually probably the X that the who our expensive may to back replacements. scheduled the knee Alden, who asked into of their replacements need delay And product but I return that So, injected having of for exciting replacements, joints. many trial, for the that some Dr. knee and earlier for work Phase came other experience patients knee for achy aspect were led of it the is anecdotal in did

is it year. be think per that injections multiple we'll using not speculate I to unreasonable So,

Tim Wright

patients Bob, could placebo? think little you bit receive it's though important more they were for the that audience our just for around option on injection the I a who thinking an drill down adding even

Robert Stein

had modified patients the pain done was so, have second interval, what for they then then The extension if know like the control for didn't single let drug, injection, And And micronized six study initial patient we had a in design, by the of amnion/chorion, FDA were for that X so six felt and could they design safety. the that followed by the drug, just month Phase a material. adequate we we the an there receive six did followed active just is the month months. placebo, blindly or active label injection open either

months providing then have them as people drug six we'll the a Whether well. active for were of the And So, relief interesting with during relief. how setting relief injection material first relief from the see first clear an very we we'll can we'll has have whether the placebo what happens patients that faded. have where the long provides and is whom who restores design, in injection receive second sense in

And So, think lot. we we'll a by it information. how design provides lot a I like this that learn

Tim Wright

Bob. you, Thank

Robert Stein

Sure.

Eiad Asbahi

that. for you Thank

want want this If Tim Is to numbers a peak and The means. $X,XXX, about but conceivable, get that injections quite conceivable? I all ask ask year three range this just translate of Tim sales to of $X,XXX price kind what a staggering. want you of I is you billion. and to guys, I million Bob. you think $X shot a a So, them billion X per and to patients, X.X are $X.X when range, at to per to revenue you

Tim Wright

some Knee can pharmaceutical if certainly you why doing do companies that's math a have do you the largest in when OA. Eiad, complicated Yes, rheumatologist sometimes on of research the we or It's the the a established area. math therapies, per at regimen is other When supplementation patients. you year, that's surgeons two year injection viscose look a accustomed that injection therapies, there something in to. the one are

of those settings two patients so, a with those year. treatment modalities in to particular getting three injections may type And be on average,

really X our with and of understand do our Phase analysis work to Xb Phase X in of coming very trial, from for and labeling going Xb. also leaders exciting Phase the be for But have drug. key to the team it's Phase We our protocol trial opinion this for out us in our R&D our is designing for the what to in

know it, add the So, work can't but we a more about to this on there's do more in your on Bob, It's that, math you that to math. to just notion that. the ahead we're information know the when But don't going any do if you have you argue we to prove that with want to clinic. lot I it's…

Robert Stein

just -- think to mentioned I like I'd you that.

Tim Wright

ahead, Bob. Go

Robert Stein

loved replaced have a replaced. five it ago. trivial. alternative. would is and medicine, about a get as I And this potential had mine I not have great very medicine replaced to have has it think to about $XX,XXX had do knee I your both as years it’s an knees

So for of contains some that active what surprising compounds potential system seeing micronized so of intervention we And or savings have memory its this a And efficacy. for embryonic bit we're the number the the intervention. that far perhaps promising even it's replacement. not delays need of have the with human and there's to to a because perhaps a quite large basis are with anti-inflammatory results very avoids factors growth

Tim Wright

this manufacturing before here make extent opportunity it preserves membrane, process conducted in the the that thermally supply put on saying tissue the this place I of a also company here tissue sterilizing to a safe here. really scientists we way and the a management product went think Eiad had through, the arrived area, of analysis early to Bob range is out in a team big important, developed also that range there, it's this the The that quality chain around or a as did laid here us. new engineering was pioneer the as for inherent and product. of thought amniotic well

be in absolutely the but to process. fair way the So, it how that that is clinical you data be important make an that it's and be and I Certainly, consideration say also thinking your same critical. will the overall approval will you important, going to product how think time every make

So strong by be and Eiad, led Scott do we to labeling, you're a we But, here focused Rogers, on range controls. our manufacturing Mark team able absolutely big Turner up. that tighten get chemistry a move correct. have There's final we'll and as through

Eiad Asbahi

for that, you Thank Tim.

sorry, Bob. And ahead, go

Robert Stein

plethora of placental an of that I point. placenta have was mammals. other, of work has over evolution just been years in a each remarkable million It well to made with Tim important going to selected is a growth maybe XXX The that conjunction factors say organ.

in And is retains make factors make that going transition product, their transmitting native that and sterilized, so and going us and any aspect product terminally so is manufacture and into the this of is to made material. getting produce and easier at be a cGMP stable active also for growth registered. minuscule. is another And which have product MiMedx a is has a been consistent infection key kind to fantastic to you converting the a starting But particularly stable lot good medical a that's it of risk well-characterized, safe to of the that formats,

So, good ongoing clinical very with on we hard Tim conjunction out, very a pointed have that studies. in as team the working

Eiad Asbahi

Tim, is product may you prevents you mentioning for the I indicates revenue think the it the companies, to then case. conceivably important say But able seems cost the need point, about the Bob, could if that $X,XXX per replacement also estimated, you if it X.X think it that. And range the knee delays funding the patients USA million Thank to that injection research pricing alone? potentially X also, for an our million be true knee in that you're that is But that conservative, of that you it. the that and true just or made if was is isn't could fetch there extremely injection, I insurance replacements. per to capture when

Tim Wright

we true. only. is the that. us that That's that's to that. its clearly, you time That had for our examine global But I issue. capacity estimate for certainly haven't think right examine range would given is U.S. The think size, a And company, the to the this

substitutes, our know Germany our products we're you are approvals UK skin have approval for our the skin and substitutes in allograft, As and Japan seeking -- our for in there. we

the there's potential the And would United so, somewhat U.S. we mimic that in do think opportunity States outside the

Robert Stein

a only which hyaluronic the on XX are north with effects million of there probably suitable that to noting joint have marginally that would those bilateral lot is about worth severe for use of deterioration. their And acid, concern standpoint on injected of helpful disease. of also long-term United than is the that idea fewer a the estimate or those an frankly, at moderate products in people it's current think for which, States. I treatment based And of be the there's steroids, osteoarthritis like best Many XX% there's

be product will, patient in may we this that that's be performs for it if it as of use population. But hope So suitable swath will that it a larger speculation.

Eiad Asbahi

Thank my final This question. is you.

fetched their X results. biotech probably stage multibillion Phase and aware, Phase publishing you're of can with X or pipeline, in have As potential the clinical dollar offers following blockbuster companies treatments massive

billion $XX For XX example, Immunomedics of sold almost Phase the billion for the was publishing just following its following for Phase results, while X its was Xb year results. last publishing sold $X of

publishing Given fetch trial of Knee we our its OA that whatever, could $X a dollar Xb could the peak exceed potentially Phase AmnioFix's multibillion belief believe following billion that takeout billion, offer MiMedx results. sales $XX

would its X explore it believe best we for shareholders a to to Phase the the company results sale buyer to interest of be take this in consideration? are strategic under Is intends management such, after a potential that something published. As

Tim Wright

well that to considering every business, in sure core on we're our option. executing as strategic as making now, our regaining we're trials, Eiad, validated GMP. facilities our are momentum Right focused in clinical current

are most your well us We're in So that. certainly theoretical examples now, there's trials, work have it's important to execute And our industry. for against right types to notion that the do. here, I And And of think plate get on of of behind this there keenly XXXX, the a lot these aware aware options. I of our we our which securities to what we must of for have us. the includes readouts board say is for

Eiad Asbahi

Thank you guys.

Tim Wright

is you foundational this other throughout Thanks, next to Thank be transformational and was Eiad. in make. interest calls to talking Look, week. we're I to and prove running going day XXXX going to everybody's we're for against up you. XXXX look year appreciate so for a to MiMedx. have forward the to very us.

Operator

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

may disconnect. You now

MiMedx (MDXG) 9 Mar 212020 Q4 Earnings call transcript