- Earnings call transcript Q2 2022

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Operator

Greetings, and welcome to the MiMedx Group Second Quarter 2022 Operational and Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. President-Investor MiMedx Vice Senior Howarth, Relations Group. for Jack you. Thank

You may begin.

Jack Howarth

With and Thank results and Welcome call. Innovation, Financial call will Officer, operating and and good Care will Biologics remarks, Wright; Dr. to the financial provide President Surgical, highlights questions. Officer, operator, Chief financial your on summary Executive are the Medicine Tim conference Pete operating everyone. President, Chief XXXX Dr. their morning, Pete you, Rohit available Robert be at Regenerative and Dr. Tim And our and today's a of and quarter MiMedx of results Stein the for Wound Carlson; quarter. Stein. me for Kashyap conclusion and second and Pete Kashyap; Tim,

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

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

Tim Wright

I’m to know excited going I sequential commercial revenue about I'm with very in appreciate of This start one, the to commercial our of morning, important five has momentum double-digit portfolio our I'm of you products. Number you, to news calling continuing four strong how performance in. and everyone. growth good you team. momentum. items. off energized the Jack, led about Thank today want I quarters

patient, and in grew preparing want of on year. September. half of unmet second with cord recent I'm to products. that are on community. And and with to research you our I'm product And I’m five, are Surgeons our and business. our what more strategy with manufacturing to I'm outcomes. we portfolio surgeries double-digit is where Starting three, year, it's last to the have where that number progress in as future year-end. complications. as recovery first revenue products underserved in two to two, are four. market. be launch worth a growth, incorporating think business our patients osteoarthritis in product can trial to are products by fuel And overall the we generating are September. later PURION mover direct and our of base. clinical, share our and the and second EPIFIX quarter be creating PURION novel EPIFIX the teams the tissue clinical that We the Tissue performance wounds Japan. confident surgical potential this we engineered amniotic of by know Number is on increases new knee registration. relationships that lower pleased to surgical bullish first our advantage risk the enhance where over can cash our wounded that repeating of agency to our for of example, new in early patients our team are This there patient better very I year, at probability XX.X% it's needs customer are track quarter expanded meet reach important of being or clinical Number investments. regulatory track for surgical our the approved pleased I about the and in a biologically procedures podiatric this our needed in development first Japan note enroll for we successful growth report orthopedic extremity only expand engineered leveraging and strong is consecutive or are important to accomplished large fourth procedures, drug in and revenue launches Number areas are continuing MiMedx treated in

of AXIOFILL products a that feedback products. clinical they I'm in AMNIOCORD development with product. for to large momentum our meet product Innovation these is in an AMNIOEFFECT It tunneling important I'd they excited limited would flexible surgical in AXIOFILL needs. availability like the full AMNIOEFFECT product developed Japan. and form size surface. to but that the AMNIOEFFECTs that broad has like cannot thicker new a release first to surgeon is conform matrix and for developing deep potential. our initiated understated future research graft further importance has and near factor to as our we products to a for collagen support or of We brands is market applied upcoming you impressive like I'd positive. can launch EPIFIX leading an of and innovative June, offers the been compliments a uneven AXIOFILL are launches of important new outstanding patient goals important recovery to unmet platform here. surgical And long-term have and remember specific development. have for The our is that September. share we and strong in upcoming your I product track and a the In market. used are growth two revenue internally AMNIOEFFECT placental suite. and serves wounds you easily utility offers novel act only be our growth new that release as as What with turn products iterations foundations on be June of not in attention part

are market EPIFIX market. track approved first amniotic on large as product for and this We mover early only this launch stated. the I to advantage MiMedx as launch mentioned, in plan first a has tissue as in underserved and as I this We September, is

new in customer with achieve objective beyond. XXXX the is efforts, Our we to in the for generating a in later impressed patient stages progress. of position specific the rate. economic dialogue in of we're final MiMedx’s and We a hired manager has evidence, productive medicine been reimbursement with process, engineering to double-digit be Transitioning innovation scientific believe think in market narrowing general business the that Ministry to we on our growth and this Health last XXX treating month. approval will I'm and on use this commercial in And physicians an trained expanding I to for use. market. us base EPIFIX. recent month, ready country the proper of and and And all additional you'll share were in our regenerative and our application our pleased Japan anticipate commitment The products, our first robust and clinical, and product biologics Japan

a enroll Development, track the on RMAT function review Type Nordic to endpoints pain results year. clinical for FDA contract and upcoming the world-class end an of B Clinical We company. Xb our first to imaging and knee Meeting that from knee the Image our the expert WOMAC scheduled trial study. as WOMAC engaged We are Phase have selected with and protocol plan and co-primary organization, next to the osteoarthritis before the Analysis Bioscience an OA use Group, research patient We

With OA increase at enrollment probability things to it successful their and recruitment like more operational these MiMedx overall are streamline growing, Board, these micronized than will can an and of of reinforce Regenerative The do milestones as recent innovate. exceptional dHACM overall experts trials. honored future industry our stress I'm and business I'd registration. initiation us a upcoming kind study Advisory we biologics to in has MiMedx one help is of is have with products. decade Medicine creating guidance has accelerate optimize of significant can platform based support, strong pipeline. a and important And knee academic commercial placental and our These year We to join how growth our MiMedx patient and wants I’m a double-digit products Scientific that rates. and pipeline on confident opportunity drug to initiatives multidisciplinary these is our view the right. provide greatly value our value and leaders momentum experience growing

turn I generating is business in the that need the is to that fuel future. cash repeating Pete. worth now to call our investments it's think over I the we will

Pete Carlson

you, Thank Tim, good and morning, everyone.

all otherwise referenced results in comparison unless are prepared second I Before basis. begin, my XXXX a quarter XXXX on second quarter versus specified, remarks

earlier, mentioned we expansion. we revenue trailing that once reflect forward, enforcement business revenue product simplifies full expectations to cord sales now of in message and comparisons I net the the the This will trends growth U.S. want be portfolio launches along since outperforming basis total that of continuing new our on our our agree. our discretion. And a had end products. you a understand. in portfolio of with strong fully in going to again, Tim continuing international quarter, the our will our XX-month quarterly highlight As I have tissue and products of hope easier basis and

million, XX, million compared in representing of XX, last over June $XXX.X product XX portfolio ended the XXXX. months XXXX. XX to represents sales net the June This $XXX.X months XX.X% our including that ended We Over of continuing reported growth portfolio.

of million of quarter the XXXX. net decrease States. million that XXXX, from sales For $X.X net sales period remember in want included the recorded XXX a to Section $XX.X you United products the sold second prior year million, I of we $X.X of

longer May know, be the you no FDA's products end XX, on marketed discretion XXXX. enforcement As of of can domestically following period these the

XXXX margin. products in train was sales primarily compared the want million XX.X%. quarter surgical market. of $X.X current the planned of prior expense margin expense In a fourth from year to than million related with Gross $X.X of million tissue shareholders. strategic that gross and double Our the the grew our million. our driven cord gross of draw fact annual to or lower impacted second $X.X quarter variances negatively XX.X% debt initiatives to Along recorded results to similar included $XX.X was This Selling, the recovery sales for the the focus XX.X%. and levels production products our by margin expand, digit quarter reserves by higher was were compensation realign expenses consecutive our force. In than and impacted discretion. and SG&A compared enforcement million affected administrative to $XX.X end of planned or and by your negative production to the meeting quarter general current attention I company's bad growth

our expenses by of reduction actions. $X.X result reminder between impacted a XXXX of million were negatively a basis. was The net and in respectively XXXX and a effect as As on $X.X a SG&A shareholder activist’s comparative million periods million a $X.X

compared increases levels. to XXXX area SG&A the growth you enforcement including sales by recovery maintain to SG&A commissions, to that in strategic travel remember a reflect and Additionally, results our our of expenses in commercial the compared This we the historical as FDA's to percentage surgical I'd the made end trends. results decision increased of period sales like of driven higher in a after growth sales our level support discretion levels expenses staffing of to force net objectives.

products We to continued the Research of former the Net put loss and legal us. behalf we remainder development funds restatement benefit The Investigation, million behind reductions compared stage a insurance gain testing expenses and from compared $XX.X growth $X.X were recognized compared $X.X over net of a to revenue advanced certain of in revenue to loss late increase negotiated and expenses million anticipated reflecting a our certain officer and as expect well to members $X.X reflected $X.X connected as as level $X.X to was and efforts of director prior Adjusted EBITDA as year of a XXX well in clinical that million of were related of increases as on decline policies pipelines Section million. million our expenses XXXX, research development commercial loss The $X million. reflects $X.X million. received compared million. loss benefit was management. of previously to costs.

as of XXXX, reflects XX, Act. the as under payroll payments compared cash December June of taxes of annual the to $XX.X cash decrease The had company As million $XX.X XX, previously XXXX. as CARES incentives equivalents million well employees’ of and deferred

Capital million, that meeting other cash June a loss patent $XXX,XXX including cost $X.X flow For the the shareholder acquisition period. six months and was were mentioned EBITDA components free costs, earlier. of annual the adjusted ended XXXX of XX, expenditures in

expect continue cash free flow neutral to year for the XXXX. We be to full

that We overall levels revenue during return period. also expect pre-enforcement discretion to to

Looking growth. XXXX, the timing share forward full-launch of AMNIOEFFECT and This revenue I of year anticipated this to XX% growth third quarter want the of year. expectations launch are later AXIOFILL that maintaining of in Japan of for our year and full to we of expectation the during XX% our EPIFIX includes the this the current of to

generated continuing million tissue gross based in on Let me $XXX cord portfolio XXXX. is the remind our you in percentage products, that revenue of which and

turn deep, capitalized pipeline. now call back in innovative and well to to to growing I business Tim. Importantly, remain we want commercial will invest R&D our the I reemphasize Tim? that

Tim Wright

our which patient as cash the third future Pete. September. Number I I momentum the of fuel investments. important and preparing the early items. on you, engineered fill EPIFIX to Japan, anticipate AXIOFILL for our to September. quarters knee I'm four questions. the and excited are news an And to we our the revenue reiterate continuing meeting first the in commercial FDA for In to in osteoarthritis strong on portfolio, Number Operator, open Number want share the strategy. Number five, generating please we are scheduled very four, PURION track closing, in year have sequential quarter the in enroll two, end. are one, is we growth you look will we pleased launches forward five launch three, that lines? double to clinical your new in Thank digit business trial of I'm are two AMNIOEFFECT track as on about by

Operator

line from Thank you. Anthony comes the Mizuho [Operator with Instructions] question. Group. of Our proceed your first Please question Petrone with

Anthony Petrone

Good congratulations traction the to in great a positive quarter. here. and quarter on and announcements Thanks see the the

So circle follow-up. I'll have upfront then I'll and a two with back

Japan on clearance there's know track us reimbursement you a mentioned, I just reimbursement. you in if an I'm EPIFIX Tim, September. can timing first is product lag a around give The on specifically, launch and for wondering update between

set FDA the an timing So here update the question meeting reimbursement announcement And second month on would around next be then Japan helpful? so. on be is the would in or

are those the walk even enrollment one look us then you a can So timing expectations as you many patients file follow-up. Phase How what the projected X through would will into deeper I'll protocols? what targeted And What like? your would be for be BLA? for the calendar, maybe and have look to then

Tim Wright

questions. Okay. Thanks for call, the the Anthony, joining

do on we our First Japan, looked at the know government application yesterday. that

a that, official imminent so until it's positive very make reimbursement is And Japan being – the that we is reimbursement. reviewed the can't think have commitments sign we word. any on in for certainly We EPIFIX we're but

and There reimbursement in I several – once launch. be our that Rohit, able are get we preparation reimbursement. do believe that everyone do firm to know. say a we'll let's have for let done do things So I

Rohit Kashyap

but of That's is can for of for patients we've once its amniotic and are believe take over set ulcers finalized, us our is new that sure creating correct that XXX market societies preparing to access Tim. expect by and making is in our treatment we sure establishing allows we will essential making also that foot as diabetic been reimbursement But working partner in Like bringing in quarters we which been with to of first and Japan local as whole we and we soon. take trained reimbursement formalize kind relationships having be the well-positioned to the product a reimbursement have and we customers flow should Japan advantage of of couple the feel options have requirement the waiting some in ulcer society, lower place that Japan. ourselves we a this definitiveness that to the last extremity more able about of application the KOLs I in are of commercialize said, imminent, around which

Tim Wright

Thank you, Rohit.

just other is it the plans it on FDA is The and this B into meeting our going question with Type an RMAT meeting, a meeting.

around people meetings, there's you in consideration Usually a more the of attention from the get lot these that. RMAT So from particularly more FDA.

meetings which So Anthony, in there deeply, that several bit we're looking This several with a includes into let We've I for had have that's crowd approaches. and big Stein particular being little good isn't meetings various FDA FDA interaction I'll which innovation go biologics helpful. osteoarthritis. our more you. program, if first is the a had the with our Bob regarding And Dr. with regarding knee

Robert Stein

Thank you, Tim. Hi Anthony.

Anthony Petrone

are Hi. you? How

Robert Stein

articulated be to why was for potent. there about us investigational have in RMAT Tim Xb and As an scheduled. on function data will It an result B in product enthusiastic do the we Phase still while the improvement pain review opportunity and Type initial meeting we're reduction the

of with to We We're registrational the of BLA our will expect year. before the in latter with for be the likely the on of move a opportunity the registration agency, potential to an XXXX, our still agency. but part which we timelines have end filing planned in reviewing XXXX late that with RMAT may forward we expectation of some the year, also because designation, trial in the start

Anthony Petrone

to quick which you would of as and look this Thanks there that quarter And in have you That's most traction? deeper seeing would And some It go and pivot blocks with to or just staffed categories are is still surgical that building again then, One recovery, into at surgical one here. congratulations. there, the front? trained to on traction the questions like point in fully good so looks very the sales force couple be is recovery. follow-up helpful. some be,

Tim Wright

Anthony Thanks on questions great that.

sales our as the partners order side, we as of in in to both market, team, force use the agency our servicing recovery sales On terms market. surgical well direct the serve

and the the continue on evaluate off our We well market to meet as as fronts on staffing both adjust agency levels needs the to order in direct side.

far as as bring and is our as As products our time the well that and sales say invest the needs, to both time as continue clinical market team can satisfied a value energy energy trained But obviously getting honestly, I in with and lot I'm in a with we more the clinical sure completely that and always leader, it we invested value that making being data proficient communicate. ever the to and and can process. ready, of that

In fact, in with energy, partners we done much training higher at lot of are more the and our technology agency than some making product we and past. a our have effort a level

that times With as around procedures multiple regards effort going platform, continues procedures, us types and to will and many as is the technology, So our recovery. in forward surgical well. application it has and have of communicated a we again impact

traction procedure multiple as with the or specialties spectrum the can risk associated we areas. as recovery Just barrier depending our are complex or patients require on to have complex recap you can or or with target location closure of quickly, the their in in complex where used well based procedures and smokers, within be The whether the currently function And seeing diabetes procedures. upon augmentation multiple be products our they product. are We that. across obese, situations some are they complex patients in the whether of surgical comorbidities,

traction also seen them are extremities. neuro-spine other in and and general and adjacent But lower wound areas like on, trauma procedures. of situations like extremity, the related lower limb including good Some in salvage have specialties OB-GYN we surgery associated so

that get of at So really data. further further allow that efforts develop portfolio, data invested focus lot we precise procedures of kind our committed we and as same us also will of to the that want more our generate a generate on we are energy to in time to that

Anthony Petrone

very Thank you much.

Operator

Thank you.

with from Wainwright. question. line from your comes Please proceed H.C. RK question next Our the with

looking off morning, me Japan, half Good gentlemen, and even here. Looks an you. for start with Thank second half like Japan. exciting just great a let congratulations. more first On

be initial target in is What's a total so. it from the slow Rohit’s over from the will and physicians be strategy XXX it like is So that still of, terms about looks concentrated this what's comments right in start there a larger or the going or to and Japan get-go? initiative target your commercial

Tim Wright

Yeah, go ahead Rohit.

Rohit Kashyap

Tier number art already be the physicians will the the so on. excited we physicians, This physicians that clinicians preliminary have the wounds right effort regulatory go of society KOL mentioned first in on targeting, network big have part of physicians X of opportunity you're will of Thanks Japan. trained, we're wounds requirement as will be strategy, exact product. targeting, through that be biologic developing XXX space XXX,XXX The of terms phases and before. terms comes establishing of a for its our reimbursement that through so the developing target extremity lower will in the effort product by or Tier the of market, first in X is Japan. RK. kind market, about the to trained in need the versus our of Again, to commercial the kind That's first of it in we a in Japan mentioned, of in as very approval there's in we we about the are a that based our and market include the order And number utilize

probably our our So And the very the we five and of essentially year our order those of to category the you is reimbursement stage but formalize of of we that, complex distributor, dealers make sales finalize distributors market a But closure get I'm effort about we there. just itself. have education imminent in now in finalizing with know relationships, is lot to Japan trying efforts, a some the those have plan and partnering in with coming product a exact to to four which parameters that. to to are of are have bringing as also to and the KOL market the reimbursement. a of can closer effort, that we we discussions to of all that value, excited on besides clarity broad we terms

Tim Wright

Yeah, our on which what successful States. than have are have the outstanding all hands to in did the launch a negotiating, I of the the we bit labeling regulatory deck efforts I positive that. is about think appreciate but team in job of an team. We're United here, broader And all that,

Yeah, almost it XX absolutely. from then Pete the wiped way you loss last And products. Tim the out, over whatever months, revenue out as incur Section put that XXX you could

XX So it what of helped of what Is the in growth actually are factors what general not And growth, you've if done to last improve increase? that is far? from that such learnings can that months are price the you it at terms, so on part part you organic least what the – and what you have grow? in it what sustain is what achieved

Tim Wright

we're head future in number ability our economic recovery clinical our data, is Number with two, Look, care education trained growth organization. as a factors. providing three wound number to the here based sales in the setting. of is our as setting, lot well sustain for data, concert room that one, three well on surgical in Yeah, growth there's medical a

starting AXIOFILL Number care surgical would things and meeting what we're need. our AMNIOEFFECT a with launch innovation The couple As you says track on Wound December back Day engine is in and really one, our to be. laid produce for at Rohit, of pillars me. we Investor products that Japan growth for in recovery recall, right our out that.

the the data response be We safety products data only payer should new to the a of data. data generating that those goal also lack of clinical inhibited of have by two that but or growth every accompany by can and year, lack not products,

As a you several evaluated MiMedx pioneering work randomized that is in based won that, very here, AHRQ, it's clinical on this did frankly XXXX, all categories which extensive and meta-analysis on the done February recall, of in a trials. in was government body

physician meaningful continue for is for So generate healthcare and workers we allied dedication data a have also the that to to payers.

in surgical We're with billion as getting So there focus here. things the really and the need is to those market add the strategy there. Japan but really know, and $X our that for our really in that's markets, combine the been needle done it's stay that you market, growth right. you to care over trials products. the OA move then you addressable there, there the when elements great on wound on are have Downstream, get explosive through strong could We focused think clinical growth Knee we recovery

queue, products every One me you to more from two you from you already as question products define really how for last independent been that two do for it this you've now can indications? defining back are ones that new that jump novel the before you a year more into of about, and the and products? I Are the going again products speak. on such the iterations stating than use right we Tim them as But year delivering are released into market are or now

Tim Wright

a think will I when new those develop a develop in of do you One, that. we need look if think you things platform efforts here. have, we need we we will to don't in and a – I a opportunity product product are in product categories. serve product at will there see we where a modify our can unmet couple Yeah, development research need our an novel that where Where and we'll to see

would there. envision As that we we this I Section XXX also stay large XXX(k)s but frankly pursue in a to area, want to extent in

the are developing, laid that – some new. over time, out, It organically would things a products doesn't we're So – long there's of existing be all completely portfolio we going those that a are out. have are some that we've but products, if to rule develop range you will, iterations

in whether Given area, from or has or you technologies, get is this a commercial academic a they technology a, a of a don't will, distribution that's new that MiMedx if inbound in calls has have that channel. company center a we on but pioneer an lot product, or a

year type last agreement. of – entertaining will have us so of would to we a form the been the or licensing opportunities over that in So we of course new come product the

Thank for questions all you, luck. my Tim. Thanks taking and good

Tim Wright

RK. you, Thank

Operator

Thank you.

proceed the Our question. from Markets. question Please of Capital next with your Northland with comes Carl line Byrnes

Carl Byrnes

Thanks for the question and congratulations on the strong quarter.

or million Just have you do trend there? then profit couple XXXX? you you in then the investigational whatever with respect guidance gross quarter, around And anticipate you was up $X.X of follow-up Thanks. terms in things those the any half And which as second you provide what also well. have think I one I of eliminated be sequential. to a fees in of in to in margin do the recorded anticipate near-term When fees guidance can here,

Pete Carlson

morning, did my Carl. were prepared Pete. point of out remarks, that gross couple line. in a Good It's margin the things It in

continue think that will XX% margin to where out. is We gross play XX%

product pretty it a I a moves range but Our bit think little good to with. mix that's work

costs in we we side, On control they're continue but executive as investigational the one really timeline. XX-K, our can to, some these that time, relate the remaining that don't disclosed prior process for

a next wind the being it of most months. down to within situation we the And year. to anticipate itself the continue that of six small single-digit see year, throughout really as should millions XX We rest that

Carl Byrnes

and mean, just I see quarter quarters that any so, factored then benefit patients or considering periods, that of up, may of is bake potential and you warehouse quarter, from do Thanks. still off first had benefit or those Great. that helpful. strength Thanks. was COVID or And one any beat have see – That's that all? second something deferred not a you those the the for procedures do of a from benefited patients other if within follow you in reasons warehousing the quick the did

Rohit Kashyap

This is question. Rohit. great a it's Carl,

I versus patients a deferred which patients that coming were often COVID as especially very chronic it's a treatment were treat, clearly identify to for in Remember are patients result in patients think years. hard and they've side of with several lot who wound wounds had new. we the of

the this the definitely of two. impact there been of So nationwide it's hard from COVID really of it's closures. implications. flow patchy has and patients At continue to of COVID, We where a there's think very in still the all over bifurcate trend We pick and access terms the become pockets the very out facilities point, to place kind from impact see limit otherwise. impact in if where to

path So we that. to our navigate continue through

are with benefits setting, – of be includes those as that as the products that the wound well other as if important in think we That find typically plan. them the we there settings. in typically in find it's clinic, And vacations outpatient opening patients treatment as the critical well is well, in the of which with up strength multiple channels. our that or hospital patients the one that of factors of again, use. way products getting shortage I for in currently as travel And what care hospital, are terms a weigh because us help situation our flow of in of there in-patients to should the appropriate with staffing private,

to volume our is the month, there from to to over go it be ready of of typically we month care settings. basis to continue see month wherever in of a not But in from kind completely the to half might month the be patient serve first the trends say effort and the half through managing business. across even we predictable So patients would second what I is as

Carl Byrnes

Congratulations. Great. That's very Thanks. helpful again.

Rohit Kashyap

Thanks Carl.

Operator

with Our with comes Thank your proceed John Zacks. Please you. question. from [Operator of Instructions] Vandermosten question next line

John Vandermosten

taking trial? I using benefits good ask and about you, to in Thank RMAT the by what the of that and morning. advantage you might KOA pathway wanted be

Tim Wright

us know you as the RMAT RMAT, type think to meetings John. whether the or the I question, also access otherwise. at good meeting broader. is a it's in attendance a more agency B That's offers

definitive expertise. So trial professionals that have example, they or they expertise, expertise, the for clinical matter expertise, manufacturing includes subject or have have statistical a from it agency

So – in data, be the your it's or in and in process. encounter. chemistry It as a to the in addition chemical your get It that surprises and that based adjacent the from helps on reviewers, confidence, product as some approval clinical their manufacturing or you eliminate control your reviewer, of you of the ranges review data also frankly data, helps whether data in can process well well the as expedited that's helps may data. which your lot your not, all

and they it's Stein, of the RMAT? couple full make this, but to think of to track So been addressing have Dr. any other the RMAT they on it's so on the very put vaccines last of side, agency approving getting I has were the questions years, now. for of that advantageous have some COVID you types you'd back do like on comments

Robert Stein

it that covers very think I well.

aspects. is have excited a a Having therapy aspect. very advanced designation are meeting with as useful the we regenerative is RMAT upcoming We Type the the meeting medicine B that that

the you you and you experts opportunity the with attention interact more ask to and FDA them at other As mentioned, from questions. have also ancillary get

interactive sometimes the And it's more standard than interactions.

Tim Wright

process to to in different The utility unique is that have certainly in in to They're we've colleagues very discussions interested of some like And development but well. we've looking approaching injectable said received not of it the really agency had those we're how And FDA. would only before. knee other know, what broad process. the at indications tissue way with to we our products, the our our we've you advance our produce PURION pleased that explore. relative as response we're as We're that OA very which John, doing, the from I'm ways the program, we

John Vandermosten

a well. as couple Okay, and great. questions Thanks And Tim. accounting finance have related

your of think that terms you'd Regarding or your if be make that seem capital how do alter trajectory and sense continues forward, forward, structure? to you debt, it looking that about to does going have appropriate the about does amount in growth

Pete Carlson

well businesses. The corner it's of And that on It in have opportunity here trial flexibility second strong will sales doing. generating in Stein positive the year allows growth, as of and the will is it, the of cash. Dr. that these I'm to we Carl, fine. team commercial that Pete Robert to sorry, cash the – us invest Pete. need resources these continue think Both it's John, the to Yes, that's sides business is generators cash. be half the work as our that we us turn for

long-term growth interest team So growth of for to needs the XX% XX% do in be to until point what as about is opportunity here two that at products our a Again, invest one quarter. launch the the talked company supporting cash at to we resources. XX%. only, I might and capabilities I reflects The about, on aspect the that the XXXX that, use manufacturing we some we've say to And later is ways but that to going this want from we XX% look debt that we're would is, and debt would don't would standpoint. in would people the remind

new XX% that's if XX% back to the we As to opportunities, in type that's develop we products of question, going next And do identify on licensing growth. earlier top of year, it. top on that

items is, And debt supporting that those levels but are fine. are the growth, for so our as future opportunity have business it

John Vandermosten

Yes. great. Okay,

with might the like quarter So about even XXXX. a what sequentially we that's to and $X Should I a subtract estimate come line sounds continue be? couple third that in items those for up we it could forward after identified worth. guess, those, of going on SG&A, to And item SG&A you million going expect good –

Pete Carlson

overall And think good use. I run is, is revenue our I expect other that's you in obviously should number bit a growth, third growth certainly rate have otherwise, yes, there, of would recur would we quarter. direct part those from to there's SG&A being that the to as on of say the isolate You our little expenses expenses is again, a our as that, something not but

John Vandermosten

one those last a me from Pete, about difference from difference two? looks estimating between for just net And great. $X you can million for there, from was is through So operations? me, where income you came to just like I that walk Okay, cash

Pete Carlson

Sorry. It was between which two numbers?

John Vandermosten

flow those, what or there, that had a second the driving cash the cash I'm and operations there big loss Just difference between that in big difference wondering factors benefit free you major quarter? because net from were

Pete Carlson

EBITDA, We got expenditures mentioned. acquisition define amortization, flow obviously and those I cash flow what's and less loss, as net patent free number. items cash of costs operations free from outside indemnification those cetera, it's of of as just non-cash free cash adjusted as Between and investigations the capital the you've et the the the or debt in outside cash for cost service that's flow changes capital that flow working well

John Vandermosten

thank Pete. thank great. you Appreciate the my for of Okay, Well, question. taking it. you, all And

Pete Carlson

care, Take John.

Tim Wright

John. Bye

Operator

Thank you.

up proceed is with Wainwright. RK from next question. of Our question with H.C. a the follow your Please line

this sure for what have end of that into FDA dissect are things KOA. create all on about in almost also the now having to on are This reflect the with things just terms plan study Stein, study. last year trying don't to and almost the the to and Thank focusing you. clinical up. going KOA that you this study, Dr. the trial with place, in the meeting, and Thank how are the you folks make for place in and you which taking longer is should you the into the or that of my follow on SAB are pieces what to going and a to be at

Tim Wright

encouraged very by We're RK. earlier was question, enough. that the was still tested for you Thank fresh the the results than product

that store that in FDA, and changes some to the study. have review use our to analysis our endpoints to made will statistical quickly product the terms and around We the our agree want we've it discussion patients with dosing plan we of we make upcoming the in and in to number how they'll this for the and so of plan. And protocol think we how we plan patients

they're the with make half the smoothly perhaps a still do was and to that second want bought and we're optimistic we before So in sure we And We XXXX that enroll into the in half stated. study approach of will or as of taking. to track on the earlier BLA get patient are end year, the for of approval second that in launched the XXXX. filing that expect go

recapitulate carries biggest through study sure this the in that positive So our entire objective make study and to of the the we part make that sure result initial is time. other

Thank Thanks. question. Thanks for you. my taking

Tim Wright

RK. care, Take

Operator

concludes our Thank I'll to and question-and-answer you. back that session. the Wright comments. Ladies final any gentlemen, Mr. turn for floor

Tim Wright

for the you Thank great questions.

I'm yet to four do, the has done still we have lot bullish Thank in a of I We in can MiMedx the about second made over Just your what summary, proud the support. quarters. half. I'm appreciate get progress you. last

Operator

concludes today's This conference. Thank you.

may participation. for disconnect you time. your Thank at You lines this your

MiMedx (MDXG) 3 Aug 222022 Q2 Earnings call transcript