OCGN - Earnings call transcript Q2 2018

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning, and welcome to the Histogenics Second Quarter 2018 Financial and Operating Results Conference Call. At this time all participants are in a listen only mode. Later we’ll conduct the question-and-answer session and instructions will follow at that time. [Operator Instructions] I would now like to turn the call over to Jon Lieber, CFO of Histogenics. Please go ahead.

Jon Lieber

morning, good and you everyone. Thank

Officer; on Joining for press our Lynne release is our the Medical Gridley, announcing morning. Histogenics' operating quarter call and me Kelley, Operating CEO; results A Chief Officer; second today this President Business Don Adam Chief XXXX Kennedy, issued and the Haut, Officer. Stephen and financial our Chief our was

our you website you a who financial www.Histogenic.com. share Investor have will it, find followed be of seen the will it which a those results, call For section business our question-and-answer yet of at On we our this session. in posted not will by update morning, and you with

statements we during about begin of results operations operations Company's the federal objectives call our of within make future laws. remarks, forward-looking the future our meaning we and financial are and like plans prepared considered strategy, various statements position, to for business and would the Before that I remind securities you the

call update or the forward-looking conference we as to make Our this undertake otherwise. statements SEC only filings. more on forward-looking assumptions, all are EDGAR on and our we expectations SEC's These All that if account is any We and website. this SEC call uncertainties. information, are in described current risk, we the changes on obligation information on investors involve in new and no are to circumstances, provided our system provide filings available based encourage read future our on fully of statements and may upon of today events

I call over the today's to be webcast. Adam advised Finally, is turn being that call recorded Gridley. now please will and

Adam Gridley

and joining this to thanks the Thank call for Jon, you, morning. everyone

Consistent in quarter the of topline trial. focus the of primarily Phase our the expect to data XXXX released for quarter in prior third preparation these directed announce X we data from the clinical NeoCart with guidance, second and of the were efforts Our XXXX.

to made Food Biologic we Drug submission positive the a in position or the XXXX and NeoCart the Administration addition, BLA the for data of launch U.S. progress significant on efforts potential of are XXXX the early BLA if and and or us These approval potential NeoCart In is or Application approved. License late FDA.

and reminder, a Phase a treatment the XXX-patient its at guidance FDA years our one clinical a superiority current is knowledge prospectively NeoCart designed NeoCart that with to randomized for follows to As the only is in compared end trial X treatment the superiority of enrolled to after consistent trial its of care. after with one-year standard of The largest three one year kind patients microfracture, trial trial show point.

we XXXX, and than database in have trial with verified in trials to In have time the today approval In Phase had advisers in activities addition being even X to trial the point, from enrolled continue preparation the large our BLA one-year now patients the treatment trial BLA All Phase are two-year on upcoming majority follow-up their potential of many XX% approximately data data and of with of prior for we a patients the a second out more high-hurdle, and fact, two X our years. by more their one-year quarter clinicians the filing. beyond end with our lock. the scrubbed years the are clinical or in and of to visits expect patients in already five patients work support the the

targeted for quarter to data support NeoCart, continue front, technical the and and manufacturing complete the which fourth early XXXX, BLA On XXXX. develop we for is or planned the raw to materials of various submission additional validation

make more several also NeoCart conversations review the the the with regarding of with efficient. this submission BLA may FDA had the more BLA believe productive conversations have scheduled We and

As U.S. for living with cases. growing the improved believe those in as tissue vast to patients majority heated year. or approximately be may Because believe reminder, scaffold, microfracture only treatment XXX,XXX cartilage physicians and that market return We of we for procedures both NeoCart the the our alternative patients options. the performed and and a to and to pain is rapid opposed cells a each activity option new in large is cells provide NeoCart more with we on NeoCart than target relief may be current

delay patient's knee. cartilage on potentially based that also the osteoarthritis we data NeoCart which prevent of clinical believe have to tissue, of generated the progression Importantly, durability date, native will or may long-term the a in

meeting that sentiment is National The Association. the clear Sports microfracture current additional annual by XX% accompanied discuss and rapid This Chicago in published patients than article for updated years. recent rate to five the better options. American in in seek Tribune failure players it's physicians the exemplified the continue to treatment the publications XXXX for July and of for the Basketball greater to treatment as article Medicine's Finally, is showing at a Society microfracture decline was in Orthopedic during use the in alternatives

median knee discussion a professional view athletes as knee that prominent cartilage treatment years. surgeons of In damage. microfracture fact, approximately microfracture was time failure either the optimal longer publicly in of the cartilage for four with they This and at naturally publications the stated much an was damage, or others for topic number these no conference for

best microfracture, viewed alternatives. it is While in still class many the by the suboptimal and as some use

is therapy addresses the microfracture approved we X NeoCart, the but Lynne a number Given for expand feedback the NeoCart the to significant member believe market team by the made and management of team the important to we shortcomings if current of of market executive alternative. offering of is organizational novel leading including Officer a a NeoCart responsible Medical the of portion that Chief Histogenics' as affairs XXXX. to clinicians launch for a building also the also clinical in the affairs we as receive to appointment Kelley approved. preparation potential changes from trial, experience potential a submissions, strategy in her the not of commercialization July In medical positive will as to convert of FDA continue Phase only Lynne BLA executive, there opportunity a NeoCart Histogenics if an the medical of to affairs therapeutic a across and educator we value topline wide variety for prepare support add data, of NeoCart. believe medical potential significant review areas and We our surgeon, in

for in years as and our the the Technologies Industry expanded and the Organization of quarter second both XXXX. than also Sue also with Sue the appointment the of CEO more been director Board XX We for Regenerative served Medicine. of in Applied Genetic Washer Corporation April has Directors Alliance the Biotechnology of

the Sue's to she insights been already be We addition to valuable of and that have will believe a our beneficiary continue organization.

ARMI. outreach it we this collaboration cell Institute Kennedy's leadership therapy engineering We with and Technology Regenerative believe Advisory the growing or to Company's tissue in have our July, increased to biomaterials Advanced relates also industry for announced reflects Steve that gene discoveries. Subcommittee industry as and through the Manufacturing the And example and our manufacturing, position recent appointment ARMI's within

Restorative leveraging NeoCart cost has provided to Histogenics additional and product including opportunities this goods. already Cell our development possible involvement with and to Therapy anticipate ARMI the expand Our relationship we platform value and to enhance with significant improvements

the we to feedback from of broad to through we NeoCart that potential intend as may platform in to support for preliminary is of completed on in While the for the BLA, work begin joints already continue advancing the multiple the toward squarely of received many conditions process have BLA focus indication. and the into clinicians the expansion believe other and submission current other NeoCart the our X and applicability next product trial Once offerings Phase will indication continue we our musculoskeletal in and may on NeoCart. clinical commercialization, with have them plan future. excellent engage We've we

we can NeoCart certain growth generated aspects improve our the that utilize Finally, the date improving we of with to the and to margins. along of process the manufacturing platform automate with have long-term believe data goal we

we conducting on June plan We of to and in a in Day plans our Phase also commercialization our efforts once detail X Annual NeoCart at additional data our work commercialization, first to partner for in Phase Japan. our continue potential planned we have by to initiation launch. X related made in support of to the intend hand. XXXX We've areas provided development commercialization planned market reimbursement these support trial in Investor Turning late build work XXXX in with additional our briefly NeoCart the upon our or MEDINET, Japan boutique early to in and commercialization and research, progress excellent

which including of to is all development the reminder, a Phase responsible As by for X trial activities the XXXX. Japan XX-patient MEDINET clinical commence end in is expected

to Jon other financials. evaluate licensing We additional markets the payments this near-term Asia turn Europe, point, international to our such over have value any in also as continue those potential longer-term I'll Lieber sales on value or and payments of create milestone and through additional to in NeoCart royalties markets. to At opportunities partnership which discuss call to

Jon Lieber

Thanks, Adam.

for million For operations general administrative to million due the overall and the and expenses increase of both the $X.X research reported quarter was June Histogenics development to XXXX, from $X.X in ended in increases quarter ended XXXX, compared operating XX, a June loss XX, and expenses.

investments burn our we have started are to necessary for continue potential to make focus we rate, the feel NeoCart, While commercialization to the managing prepare we if approved. of on

stock increase second in quarter million costs the in value per and XXXX. potential the convertible higher NeoCart completed primarily to to Net is to the or issued the was the $X.XX and quarter increased commercialization the in the administrative to support common were attributable of a or expenses change support NeoCart. attributable an to quarter per The we and connection second to increase X in $X.XX conversion XXXX increase second to stockholders was some compared NeoCart the offset a in of on primarily XXXX offset due in quarter reduction the into development of activities specifics, placement million and generated These due BLA which fair quarter as to and in submission by XXXX. as share second research salaries income XXXX. the consulting in second compared net compared to the XXXX to stockholders of $X.X common with warrant share expenses. quarter decrease loss of loss XXXX completed in stock Moving expenses partially in the XXXX common second enrollment in potential operating liability to private $X.X year-over-year quarter June was the which in by Phase trial the related of for preferred was second to work due to The clinical general expenses related of in in was XXXX the

of a As dependent the warrant including a is fair the our share reminder, price. value liability upon factors of number

For expense impact likely the or given is decrease the in example, result fair to no an increase generate likely of income to value while cash the will a quarter related change There to increase related price in warrant liability. share an of in is the in the a income. in expense warrant, from change

fourth $XX with a those outstanding point, a warrants we approximately fully not currently XX.X shares warrants should expiration, with shares shares their million connection outstanding. holders prior do million and XX.X to shares reference have exercise diluted XXXX exercises approximately price These strike As will proceeds. have provision, a private fully of the million we issued include the warrants diluted receive placement. $X.XX so XX.X million The in in plans cashless underlying primary At million cash expected December XX, at timing and before position $X remarks equivalents, will our XX, of compared to development believe current I will on the marketable we to XXXX. for $X.X call our operating of and the turn programs, XXXX. into the had to our we Q&A. Based go current back million cash, now XXXX, quarter operations Adam June Histogenics of cash fund product concluding securities

Adam Gridley

work. osteoarthritis data the anecdotal example NeoCart we collaborators in the feedback product patients this clinical early that employees, and be quality my all in important our on feedback appreciate from Jon. and thanks Based from with hear able performance to NeoCart The treatment finally than surgeons knee that and to cartilage offer very to also with clinically from the data sites who's may this I'd and very for date trials If us to unique restore about and meaningful knee. response XXXX, want clear have we believe the procedure investigators and an be get treatment restore life. to the June clinical consultants patients in any different helped This and them damage or market on Thanks, We and risk could superiority experience get in We're to their and participation is we the function compelling. their from pain trial. the potentially point, Day and express developing in hard for NeoCart with cartilage our their may robust our to Investor patients clinical development. like provide recovery for a everyone to reduce option heard continued on I will of effort of or profile the approved, in sincere patient's their to thank microfracture. helped honored encouraged the their generated their of and NeoCart when currently

our reality months sharing progress you joining now for open potential that transform for are today's and call, any to Thank I ahead. up line you up Operator, diligently We questions. look please forward we the open the will the with line. to in working into

Operator

[Operator Chad Messer Needham Instructions] is first question Our with & from Company.

Your now line is open.

Chad Messer

that you that are kind exciting in the it, getting At I question close. It's we analyst commercialization. participated the you your marketing to of so pretty sales trial. tiered clinical third is just my weeks are and count your of day, would out left on My to in out XX kind you talked effort to got first sites darn of on high-volume you, point wanted force seven by focus quarter, your initially about guys, roll

average? give could in detail, there of a more what typical, you a if one paint little looks surgeons Just kind sites do they of maybe a on typical, wondering and these Are it picture many us they a if how is like, even have all are primarily to using them sites of do one volume of they of what within some the microfractures more just kind there procedures. is or terms doing or are opportunities of NeoCart, other them,

Adam Gridley

and great Chad, questions. Thanks,

are we a bit. And something that thinking about quite

think I sites. depending varies that the the of it answer So the is to profile on

say So details. with couple let's can a Chief and Officer of let Business me some paint in a categories more on Don, our picture join then

for So at is and be into number about, certain have even example, research whether institution volume for of Diego XX or the and combination leading where to they bring based the private on similar cases, at mix the top And your many to at enroll then we've we seeing let's sites put are at are institutions of a I each some as medical talked of that that type patients. a potential sites that really on of San or done, KOLs based know about pretty as of that as see sites in though, is of us the a we of the say patients very but going of of patient, to profile roughly we practices have presented opportunity based for a sort on we need to example, XX surgeons a of the those overall, we those there. needs, course, have to Mayo, there some up HHS, month insurance helped market private plans at across that that X,XXX XX believe sites identified, also medical practice, the in place to or on look we in I we patients Bozeman. the of, month think regions, a XX these opportunity that large in come policies, it of will from link the trial, we some had large in the the When strong

we the XXX a year. much or in do the to having to patients these XXX profile XX microfracture Don, conversations microfracture add want of have you Now, of these are not the as as doing XX as folks but to little and procedures of to advance you a been that. some some on seeing procedures average, color with sites go year to through, going are all as

Don Haut

No, on the with they hospitals I and and XX at to year are we've the of on certainly I XXX think, larger the XX reiterate I the right institution in kind higher-end, and they are that to would per XXX, to the are end, said, what mean, they teaching XXX seeing. say just line would the in XXX microfractures is Adam low I had

Adam Gridley

significant investigators. three you second coverage, of private two the number may then one volume practices of areas some each some and was a your part in of And fact investigator, regional have question, are Chad, there large of in the many and primary where or have at may the larger there and the or have of investigators or sites institutions there terms there's one in

So example, then which broaden about more there sites three the have in for in are lead investigators that XX XX site but the partner trained, trial would Antonio, the primary out, in become are the was all itself, the familiar, you very take San we get but four U.S. that surgery. investigators doing when then of there or

know they and that So be and strategy new CMO, our part will about our NeoCart education affairs would lead. that our program medical Lynne, of

Operator

Our Jennings is next question from Cowen. with Josh

Your open. is line now

Josh Jennings

you for to was believe and that is different just and in to clarify centimeter potential off size squared be I start is you indicated expect inclusion Phase was to approval criteria X squared, sized centimeter commercialization? expect, X lesions, X.X NeoCart hoping upon of the and NeoCart's range in lesion that I

Adam Gridley

lesions believe of a was is our plus generated, X XX% yes, profile big about that, be you is which sort maybe clinical to at of at we've based we've up we able centimeters our grafting treat centimeters, focus on a we NeoCart get size you for really the primary lesions. product look Thanks microfracture X it's pretty a and the data then other that actually here, centimeter square square the larger do tissue at microfracture about to market, when Sure. when square up of which created other is probably X actually was a when there, full X really Josh, developed know to about overall for the question, clinicians and that quarter. and treat square looking And centimeters, point, what to procedures they're target much lesion, range

distribution which So lesions from and the right indicated trial way centimeter X to up believe up treat all square microfracture used is we X often a to where range. to would the expect toughest centimeters, small we that the to square certainly nice be has the are

Josh Jennings

do just about than that and now thinking I of payers smaller on believe a expect centimeter most open Great and smaller with a size positive distribution need there do ACI will you out trial. analysis out the different lesions and lesion squared, the lesions have floor you X the the you for of data to Phase whole play up subgroup think lesions because to reimbursement. or within of or your nice inclusion less of decisions present smaller you have bottom then a size centimeter X just Do how criteria had you you set are X said the of squared, payers can to

Adam Gridley

actually ever is of of sufficient. big FDA in I will go bit I criteria, of the the been sweet sort largest the this until of lower hasn't that spot large evidence body done, given we the been guidance is think comment number square we have the are the of products quite other done than a end think of be believe than centimeters into don't and the microfracture. will of that lower of trial going it the Don body actually to most evidence and and that more lot have on that I conducted that using it because has issue X this much data The trial there opportunities. a work of that single

lesions have also a function, centimeter if to of So alternatives way there's strong the the got clinical there of framework contrary, I you've equal no lost lack bigger smaller there's The is and are have at is and available this to evidence X data down really you lesion, lesions example, way, and more to lesions. these of technology with isn't for lead an if clinicians pain evidence actually correlation some in square those to of of the painful that the not a treated. believe opportunity or that sort look artifact if but so

support if much So and or you X treat into look of time very got X a to have about that data And are that, the is strategy to it and grade you the that at part clinical data going loss pain if more you've that that. lesion our grade much function, payers the I it's for got payers. to taking and over clinical a believe product finally of

really trial after have are add? first will bit set microfracture know a work well up. this Don, of So on been I worked small Any would to where consultants payer with you those And in doing be the go you then how reimbursement additional lesions. thoughts that it policies quite various

Don Haut

what you centimeter. that, cover policy and to just No, there would number some cover to that are well a there are add as our centimeters, X below in while down X.X research, down square said X by to that certainly that I only saying

Josh Jennings

maybe chunk procedure Do X of a the at have the squared all lesions. X volumes centimeter think guys it's look but of seems we microfracture been research for overall sizable less of are of to percentage it less centimeter take And you detail you cartilage definitively like than a you trying lesions lesion where any than in can market that kind squared? fairly the have just kind terms and of segment

Adam Gridley

both our X regulatory publications course, lesion least our past clinical X, average bit of last around there At we a similar years, prospectively We has trials, phase over the don't little disclosed of the the this, because centimeters, couple designed from demographics, lot in past XX the in a ample now, conference And that or been the square the XX then calls. challenge over and in right studies and the so we've although got weren't clear. size know X of evidence have was our partly phase trial that in north guidance that. of wasn't similarly, we then

growing. what of the of conference square in centimeters, square most data X the the of So above in centimeter is you patients is that the recently certainly in are where for Kohl of at our to microfracture size literature, growing is and the is some on in. sort outcomes square centimeter When data July meeting microfracture those KOLs where trial it both that independent number look and microfracture many past or that's done range, of lesions, which larger analyses bunch to do other X and starting X coming and a the a now the couple start square indicate we poor the centimeter are by a came of plus are whole And are failure seeing autologous more you significant and centimeters, the that whole not of rates lesions, at in X all centimeter saw of that are another that also X probably would when like centimeter other come but leading where to some just centimeter X square they've demographics centimeter therapies, got And and then recently sort both range. done has see what anymore retrospective range. this we a probably there's starting published square patient be XX% out AOSSM to XX% clinical in sort that X then square of small X studies cell the that been of XX%, just trials, then for getting X whether microfracture, to of out you

Josh Jennings

get kind just you on, your historically next the just on was thinking I anything balance cash just last to here position, international And think few potentially payment sounds X trial, with about it could just on also on the potential Phase question making position options cash progress talked maybe other help capital Thanks of could terms And have congratulations your is the agreements and in if there. help my which front there's the are what months? the over burner through an like upfront you and wondering gentlemen. Japan in generating us you about sheet lot, a of you're

Don Haut

I -- can can Yes, the about geographies. talk Don, I talk other this is

actively still are That partners in before, are potential a said, seen by geographies As there out there, a we ground exploring of is we're what said days, conversations. in I lot partners cover a far. we've Asia, actively there so say especially having potential would other are encouraged of we still we and there early -- to lot lot it's are out

Adam Gridley

And the on cash side. then Jon

Jon Lieber

obviously cash fourth into Yes, we on as the the we we cash disclosed this quarter side, Josh, of year. have

so get we quarter make into is not quarter. to XXst, good cash to Just us do the it being fourth not the fourth have October Xst, not clear, we December are say cute ways when to we

are to looking I balance clearly -- are the above as data, of a at some doing so need financing but we while manage strategies, that the get that We exists shareholders been preserve value the can so the capital The our the sort plus solution think long-term for bring form debt come take for we likely more when will over we in near onto deals all think the Phase of sheet, perhaps the would manageable account some we also the at all business X today. of of have do contracted well and are potential for the into inflows requirements stock to exercise development probably XXXX in in but and people of sort inflows, as so we existing is term, that after objective in look equity, BD we the warrants evaluating from you capital of especially example, upside or new the XXXX.

Operator

with Ryan Our Zimmerman is BTIG. next from question

Your now line open. is

Ryan Zimmerman

very Phase So I on on remind itself. analysis and the dual start what saw early threshold follow to how is question. the that investors just trial a the you what X I the want a in to Adam, from dual X Phase on compares data analysis? up then could for responder and And the have remind Phase the us X or you responder data

Adam Gridley

the Sure. Ryan. Thanks question, for

that Phase so many analysis and trial clinical pain the responder of was years And designed at a function. X ago dual looked threshold

we function both been further look to average EMA, they So We very the scores and and the on and have all on improvements of step rather it function. that pain at outcomes. improvements all against see endpoints, the patient of on a trials want as patients, took each FDA, PMDA, looked at clear reported looking than responding all baseline on patient at but every pain

naturally is if sort vice those or if on that past a lot we of scores of thresholds this think germane year, they that a isn't about in versus made microfracture certainly it at reduce is of and both, so the all though the responders patients trial and and significant NeoCart so because where going you of really only whatsoever, became are And and leveler. powered then patients, agency accommodate and only the your I Phase XX the looked percentage outcome the responders. patients order for I true to function, one that's then X meaningful for a between function XX% responder. are the statistically highly microfracture -- NeoCart pain, patients or pretty you so clinically patients responders And we even on think microfracture. versa, saw being average pain so will the significance And XX% a their And any meaningful at clinicians wasn't responders believe of difference of it about the NeoCart being

of bake a statistical your really we X, exclusion demographics. X same bigger some inclusion, version Going population similarly would Phase what criteria, built Phase on out patient positive, saw X but was we did question the into that and the largely When it's the be to assume wanted forward we conservatism. Phase then, result the the to on plan, the that

that of what in amazing, rate. the where a X a in that's trials, assume X, we sure the Phase were bit similar when And So to responder Phase patients, for rate trials nicely Phase XX% NeoCart have we think conservative. responder but percentage the in but microfracture has roughly make would wanted more the assumed design we you outcomes designed that larger we're be would the points where larger X XX we that we a accommodated you'd see

to need at percentage XX threshold year. XX the responder one delta see reminder, roughly to as and hit between is arms would point that we a to So about that dual analysis

Of to go is endpoint our course year. years, but the one at trial three will out

Ryan Zimmerman

submission BLA may to what items submission, speed then in view And of than the that initially longer and that helpful. conversely, may Very expect could the take you can potentially BLA up you expect. may your some on speak or

Adam Gridley

Excellent question.

and So on to load every look agency the conversations of to things regular to the end various opportunity opportunity at of front going with up, course, certainly in to are we're we them. speed any the dialogue

then a to usually for that which our if BLA approved, have roughly product XX-month tremendous review acceptance the I were at the think information, actually filing see period look timeline least and you case best biologic, we is this a getting roughly the a expect there though. for at MACI, a PDUFA period, would prescriptive it's two-month because that's review so job And and did Post of review. do statutory to similar roughly BLA we Vericel's timeline. is was of in MACI, time that which a

under may be year, year around a probably a everything it well. if goes So

of to we is the agency course, is our with always at of right great we the these and spot. sweet with, think with try as has be about while some possible. modules, to load statutory Generally So course we pretty continue straightforward sort opportunity requirements, the out, been how not But agency take of the to that downside, positive, to some then the up. end the goal of those guidance uncertainties as conversations think to mitigate risk of speed table. first is there believe a we preclinical we going that think be to hopefully in the since to to manufacturing, And continuing given to agency documentation look we guidance FDA work the much criteria On speaking, that are any this dialogue front are about are risks. probably in of with is designed lot we closely the that off came and clearly so to prospectively trial going enrolled a mind, review, be data the that I

Operator

question Our Instructions] with next Wainwright. [Operator H.C. is Swayampakula Ramakanth from

is now open. line Your

Swayampakula Ramakanth

quick of couple A questions.

Just on the market, about guys. the microfracture market in talking your prepared remarks, for you are erosion especially the

if of of a that? a And you how is that your true, is take there market is need of them? for that advantage the different would you strategy So kind apply eroding that? sort of to in guesstimate, percentage And what for

Adam Gridley

the for Thanks, RK, questions.

clarify, recent are that? was it on certainly that to microfracture the and and the of related to some we question market the seeing that given less just usage, how of capitalize So was data, we

Swayampakula Ramakanth

Yes. Exactly.

Adam Gridley

Excellent.

Now, challenge as question population we some effectively a certainly, what is this know is don't a over you that follow to they a get and think really microfracture great standard. technology the be this that think you in time, still I and gold great for for there do see is one response microfracture scar are I a where tissue that good was big does, making patient results. The the provides is when durability you which rehab, hope of

as even years. it's that new some that in failure high are of XX% years of X the greater time XX was you there to we XX, here isn't heard July is out are, we data as starting and AOSSM, data body the so later And a rate where what coming get with median this and are published four clearly that's at hey clinical to alternative great XX, now at show really saying failure years, a large

hey, good younger you Certainly, when the really challenges tissue, a patients, be you to high regenerate of treating lower propensity older this going from And they I for not not BMI don't I where know saying: hearing while get in feel for so at we are example, been have pain about have this it's patients, surgeons able because doing there's a last. -- lot patients, to to think are lot the for as to a a call working outcome big surgeons running these source that don't to station, weekend and procedures and that in so to train product the them parents an that's and of primed high people or provide use a lawyers as really for for these particularly opportunity microfracture quite is sort issue. simple waiting we bring of satisfactory demand or patients,

direct the the so have. alternatives ago that are sort of couple across saying the from of surgeons And board conference best quote we of months worst this a is the

an procedures private for response And are so of that to we got would clinical that. earlier and waiting time a target of that they easy, enrolled. finally have do went so recovery think market. I NeoCart that's trial folks lengthy just our practice provides and We that's and a be how something And lot lot provides don't to the

Swayampakula Ramakanth

also starts And you the the it time about median where of seems like were kind talking four-year time when point fail. to microfractures

package include that submission, So or BLA the you that within to been that the as that is data -- point have if are you good up will with what microfracture. could that to you get than could also now that better you that you a longest the when you NeoCart show for treating now so while is time that true, point have you've patients to

Adam Gridley

is that. Absolutely, that I address think a ways of couple I would there

into by Phase data to and as study that published studies a Lynne the term set. patients what started already on patient a throughout get have as Phase get we've those the XX about to of six XX a to has of a three-year probably the five track registries some of going Don patients be year data with years to is going reminder, things one. time to that all working sort that that but studies them first to approval. to studies And and So outside endpoints, going be is to In various is move And have from we're of longer ago. to file X of will seven we clinical approved X be number our is years with the the robust of three-year trials we ongoing reminder able FDA one

discussion all of of have a of would two-year expect at labeling all So it is of then data our course three-year with time almost part shortly of approval, augmented and we would the that will potential the going and be to thereafter. data be

body So a not data, patients with of as this going is we move number to data huge have large of one three-year year a it's evidence, we're commercialization. just into

out information presented R&D future until June, we Phase to unbeknownst that registry we this still XX one have investigators was level is well. and the you us years. the to one publish, expect in new additional And website, our he out that expect day, We has this who commitment publish that call surgeon also happened the have of community. would we we on the as to publications see in we out from we'll will been clinicians, with our constantly to heard those Finally, we that just and we're to our who will have patients various bring that evidence trying the work X

but to that's hearing years. but number to at of not patients and our we out to only durable consistent out regularly hear X, we to this initiatives. in we pretty And have call populations track to in are them, have small XX Lynne's So come patient those. clinicians X goal be continue or and the touch going do certain it's patients response in XX and be of would And get easily us early but now initially, are big a the will and with told they them back sites, that one be certain can

Swayampakula Ramakanth

follow are in the do we of that States? like market the cartilage on of question outside The are is market and last pretty much targeting, repair what that it here of United United does States, geographies for is the the current terms -- potential in China, there sort me what is you the Europe and from just what and potential treatment which

Adam Gridley

very, volume start but a let's other consistency you is with the market the of and or data we've microfracture Don are in also available has products China, have that for and while then sort despite between that have Europe so of lot Japan, with even scaffolds in United the Europe seen say with less years don't sufficed. leading some research a that in U.S. still Japan, donor you what the the large very will research overarching example, have. comment options a the similarly States. surgeons is frustration ethically, best of But we in for has still just We Japan. market overall, tissue have who markets generally couple in market certain an of where I in China, XX% dissatisfaction speaking, regions been we example, that's the know they And have in said, allogeneic ago, in procedures, level than and we strong roughly then of have did, doing congruence done, it. tried preclinical in don't also level and certainly microfracture in Surgeons options, in of not used, you current may you others actually been

or this is it's can that: doesn't the best one and arm we a sure So reviewers, in a when it so for trying example, work, microfracture stop totality using but we been microfracture test we getting can of look, as similar. what that so we be the different let's show add here? know each and has comparator. we'd overall, small regions, that I'd were not the they say would saying, research to some pricing superior have, yes, while reimbursement on the or are make anything new let's were you may market hear that and we China alternative And do feedback the they the of Don, indicated confirmatory this from [ph] much example PMDA, the we negotiate there, study you anything remarkably we for from are of seeing different

Don Haut

medicine going a to beginning sports would only at microfracture look up done a from say to place do there China as world the developed there and and I practices while because the big in would specialty. is like they build I their add they and this the probably lot. the what still And a United around it where that's again, are not as want big markets we thing we establish specialty say is -- just would I procedure well in perhaps frustration and up as as a to there with more this to think States, themselves: as data why build there, why they're

significant we what alternatives receptivity very found think microfracture. is to to I So

Operator

further back no showing I Gridley Adam like call to the now I'm to further questions. would And for any remarks. turn

Adam Gridley

data the day. Thank committed our significant it's participating as the as you, operator, and thanks think to the remain NeoCart. on very ever a executing we We exciting opportunity to are and call updating shareholders everyone. Certainly, Phase we trial who a Have X everyone to forward and topline look on to the looking one in superiority year are forward NeoCart from progress. announcing time offered XXXX the we the third good day, for our quarter company by

Operator

in Ladies conference. thank you today's participating and for gentlemen,

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

Ocugen (OCGN) 12 Aug 182018 Q2 Earnings call transcript