OCGN - Earnings call transcript Q4 2017

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

Operator

Good day, ladies and gentlemen, and welcome to the Histogenics' Fourth Quarter and Full-Year 2017 Financial and Operational Results Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] And as a reminder, today's conference call is being recorded. I would now like to turn the conference over to Jon Lieber, Chief Financial Officer. ahead. go Please

Jonathan Lieber

good and Thank morning, you, everyone.

press today Gridley, this Adam me and for Kennedy, Officer. the call operating and financial Chief XX, are President and Stephen XXXX A Operating Chief ended the fourth our our announcing CEO; results morning. Officer, Histogenics' and Joining Business on release full-year Don December quarter our Haut, issued was

On who available our and you results of a have call www.histogenics.com. on website by followed Investors those seen you it's will question-and-answer not which we For it, review morning, session. of the Section at with financial will our this yet be a of share our update business

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

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

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

Adam Gridley

achievement in NeoCart joining this and quarter additional all with positioned clinical topline several completed in a enrollment XXXX expected And of quarter importantly, in XXXX to well beyond. XXXX, of III We Phase Thank the create important in of the in year License to of you to had you, subject XXXX Phase and milestones, Most are launch the if with we thanks Biologic we on call for we to very to positive third the productive and June value morning. III Jon. also in NeoCart are This track lead an a late may the report XXXX, of filing trial approved. third data in data. Application XXXX

reminder, current and defects of to cellular clinical a NeoCart treatment is trial designed, despite a care controlled the microfracture, knee. used III the Phase well-known standard is in of prospectively limitations, procedure its cartilage randomized, trial clinical to the is it the As Microfracture comparing the With cartilage small, a believe most largest of to frequently of cartilage patients the in this by safety its physicians knee. evaluate defects we and to the defects efficacy trial knee. the in is XXX painful to treat the a kind treat enrolled, therapy

procedures cartilage patients to is special forward a faster seeking damage with And the it's is potentially a relief make trial function more clinical NeoCart addition, we market development. and behind milestone with to superiority us, either be recovery. enable experience a only U.S. to design currently one-year suffer and are Phase which III the rapid changing who of ability on the from and we covered protocol that other due in In game assessment to to to the under the or pain with available therapy enrollment FDA. to look unique return products Furthermore, opportunity patients endpoint believe this knee

and to to a feedback successful expertise immuno-oncology provide the quite with formal enter agency of development our initiate from a in for ability or was The pharmaceuticals intends clinical XXXX. factor Japanese that PMDA in including execute leading for in in completion potential for the half in on and significant of market made NeoCart development Japan in and XXXX Japanese international $XX development medical also NeoCart on company by a sales. Japan market NeoCart Japan successful We agreement establish could regulatory Japan. in trial one-year NeoCart of clinical we clinical MEDINET. trial, in the our which completing Japanese platform important cell-based progress the if foundation patients upfront tiered would pathway confirmatory of III and MEDINET believe XXXX the authorization for million was agreement December We MEDINET in addition approved the agreement spring regenerative in in to on NeoCart licensing with the second the received therapies, XX-patient, constructive, and sufficient in in the up U.S. A be expansion applying Phase data commercialization indicating medicine for microfracture discussion the royalties comparing to milestones with The PMDA manufacturing our in MEDINET million payment, build An the of marketing devices payments includes to to the full in of will franchise from therapies Japan. to $XX NeoCart Japan. total a a and XXXX products.

that in in in with a our Regenerative to Medicine order from U.S. executing laws orthopedic and in clinical on Additionally, conducted of supply may NeoCart's of and recently of noted for strong surgeons response. our covered surgeons we as from strategies of XXX are may pain and NeoCart satisfactory solutions U.S. and commercial offer research safe XXXX. recovery assumptions potential as the the cartilage note, therapy. launch and the the return potentially regarding as and sports Of market in be the Japan the well In rapid advance the both patients XXXX, desire PMDA that fourth approximately confirm more support manufacturing microfracture trial for maximize a quarter novel current we as a pre-commercialization The a Japan we the of in potential, and agreed research market, across the for to size durable primary function using results need significant NeoCart need Product, to the regulated the States U.S. alternative would Japan, United markets. NeoCart. In unmet that good the confirmatory cartilage processes by the lack medicine the enacted each both a repair and our repair treatment of effective

generated of meeting the and if To as positive believe clinical week. that a garner development of American with the NeoCart last of NeoCart, In indicative addition, Topics intend amongst anecdotal the regarding in that end, feedback generated biomechanical receive We with efforts during can groups clinical and meeting receive Clinical group a Advisory NeoCart. and commercial from Board of convened we direct support is tied key Academy covered held commercial that future to including to to University approved. in experiences to we Cornell continue the a SRA their between patients our Surgeons NeoCart our who and use help to-date, part discussion of patient this feedback setting those this our setting. linage and the data Orthopedic strategy physician datasets data our the

the RCT Phase peer-reviewed from Therapy Moving to alternatives. of other cartilage body of of conclusions biomechanical XXXX, at supports collaborations data publications the potential the of and XX% pain action the III evidence components physical a than growing at which additional NeoCart In in broad believe and treatment get feedback remains mechanism clinical native the on work we back the studies platform. from submissions treat and more The our potentially NeoCart XXXX the of from clear ability characteristics. to the we Restorative correlates underscores or treatment, time and trial and patients presentations upcoming of our Cell regulatory that activities these source from summary has generated to the of other NeoCart's to rapidly anecdotal data approximately provide highlights the of

also also additional our opportunities NeoCart studies at and this a based posters several and are collaboration Mizuno, month human These at School two just for or NeoCart. Brigham evaluating cartilage of our Women's additional or RCT in Implantation Chondrocyte ORS from were the ORS. of and podium the results NeoCart and Medical product been the RCT on multiple data engineered presentation Histogenics, the data have entitled Research Society Dr. Autologous platform Shuichi of And delivered annual of platform. Technologies of Orthopedic NeoCart Harvard NeoCart The aspects on Cornell Scientific on Founder Additionally, at development data technology Generation available more presented meeting. Hospital Third Platform our are corporate the a important presented website. posters

Officer. Operating commercial important front, Executive strong NeoCart and Technology corporate manufacturing ability Haut Officer. in we Kennedy professional promoted Vice to the Steve In to October our subsequent we prepare that Chief XXXX, Don of is Business to appointed both Steve Officer potential position for and to experience the and President XXXX, Chief from launch. On Chief possess June Don

We offering of further filing. employees XXXX successfully to us as additional beyond. of and registered generate clinical XXXX and completed from in XXXX net success help stock NeoCart potential of as million. also in advance in sites a momentum proceeds January for well The important $X.X a source common BLA raises that offering positions our physicians our of patients, the in and funding that aren't direct Proceeds flexibility

topline key corporate Most remainder few expect importantly, highlight the Now take report our NeoCart in to we XXXX. quarter. third Phase III the data I'd a to like moments to objectives of for

our Board the beginning and yield our of BLA Assuming loss to launch. we III milestone cartilage Company also this who a XXXX. preparation assembled critical additional advance the functions. design the potential to positive potential data trial. Consistent third build meet the medical The of reimbursement half strategies a to from superiority our are and and results Phase with optimistic of leading commercialization the advancing Clinical secure XXXX develop affairs requirements commercial strategy in the microfracture, our and will of To years, NeoCart Phase marketing patients will function to quarter and end, suffer the the we our to Advisory over for positive and trial positive we in submit FDA will intend and additional in U.S. we marketing plan build-out III include We're in manufacturing This NeoCart the the data BLA approval support many that to development topline and to increased be in U.S. have the to subject pain and clinical initiating optimism of FDA plans manufacturing of damage. for initial second a Phase clinical for following positive to the and results due the and continue from of submission launch for to trial, out III subject sales NeoCart future from capacity NeoCart. capacity manufacturing

also in supporting will closely the planned regulatory second include We support activities the in of half plan NeoCart III XXXX, trial manufacturing Japanese and for clinical Japan Implants Japan MEDINET's NeoCart trial. to for MEDINET clinical clinical work with These with Phase XXXX. activities PMDA the the the and Phase assistance with discussions trial III

to licensing in collaboration to plan of NeoCart North believe explore for also be opportunities continue partnering in significant there interest Asia Japanese We may based additional additional We for our America. recent attractive discussions. opportunities outside the on

NeoCart. past with our BLA soft-tissue U.S. that and Women's and continue foreign disorders the these products as three-dimensional our well additional to Brigham to from and and support collaboration Women's. to with collaboration additional additional of Intrexon develop such XXXX, or intend existing regulatory potential with from new to result collaborators, and to we filings and the including as Given the anticipate generate to Hospital, presentations commercialization the as of printing in and biomechanical with the Cornell, success and data work and data XD publish use chondrocytes additional will publications We collaborations Brigham musculoskeletal-related also treat Cornell, in partners,

Lieber also intend our further discuss objectives over I'll collaborations financials. support now new evaluate to corporate NeoCart those to RCT our to to turn and Jon summarized, With XXXX call platform. We the

Jonathan Lieber

Adam. you, Thank

effort December and expenses. operating to a for million our reflective minimizing December million the in Histogenics advance loss and development general reported offset expenses is a XX, year $XX.X ended burn ended XXXX. from by is year research of and rate our that The increase attributable NeoCart decrease was XX, in to reduction compared smaller the to For in loss on development administrative the of $XX.X XXXX operations program a

of NeoCart completion of continue related trial, our related III and the planning focus the the We and for to administrative Phase clinical BLA, on efforts if potential approved, the expenses efforts. commercialization NeoCart preparation of

expenses conversion $X.X compared to placement reduction loss primarily compared wind support research operating million, per XXXX, costs a difference per the in relative as of maintenance in to in decrease consulting million personnel-related to concurrent in clinical in is share, compared the $XX.X private III by the as trial-related The Basic expenses, to common driven million some of these clinical common submission in expenses stockholders preferred $X.XX connection in expenses XXXX repairs Moving consulting net in enrollment to XXXX our increases to decreases stock to loss of decline share stockholders and was is changes common were to attributable million and and $XX.X stock due by with administrative was a in facility-related primarily increase attributable expenses with in the common the to to attributable in share approved. increases XXXX warrants the issued XXXX. Diluted offset and fair specifics trial. in to and $XX.X in basic commercialization $XX.X collaboration, compared temporary the to Phase loss personnel-related XXXX significant share, XXXX our offset costs, in portion year, BLA XXXX on in and The loss $X.XX per were operating private $X.XX per net expenses. convertible XXXX. and to XXXX the net XXXX by issued due to NeoCart for connection XXXX. XXXX net of largely reduction in in placement well. as potential the to million expenses. $X.XX in The up or $X.X activities stockholders of in and recruiting in development labor if into attributable diluted million NeoCart in or or Both expenses increased of was with and or value due the were General

primary a fully and reference currently point, As shares million we outstanding XX.X outstanding. have million shares XX.X about diluted

placement reminder, a with XX.X include fully exercise connection the in shares do have XX.X not that As private warrants XXXX diluted million issued cashless million a provision. the

XX-K ATM the the current also into and our Pro and Genuity. on and of Histogenics for Based $XX the common amounts stock. marketable should forma to prior million adjusted million. XX, programs, Canaccord warrants and cash would at their expense these holders between $XX of In receive was compared So cash will million, operating exercise our XXXX into had our plans $XX At of operating expect in filing December to securities we XXXX million proceeds. be of fourth expiration, those the December cash, position $XX.X approximately timing net to million $X proceeds and believe of at to the from XX, of year-end direct XXXX. Cash at agreement quarter million operations the development with $X year-end cash $XX proceeds net million payment we in conjunction in with from XXXX current XXXX fund today, XXXX. approximately excludes the million upfront the receipt $X.X related offering in registered agreement approximately January an XXXX expected we entered offering approximately MEDINET product equivalents

Q&A. believe While before capital, back raise have governance we for this have of turn to I now tool we to a no to additional available broader that as Adam go financing remarks call is the it immediate will strategy. concluding part to plans we good

Adam Gridley

and activities healthcare NeoCart and unmet address the NeoCart treat growing primary this a body for ever. results cartilage to potential firmly more to a solution and that that the our novel market With a has We than if and three Jon. data grow there Thanks, of are a provide such expand knee damage of the our is market. customer need research anecdotal and But competent costly product challenge. complex may groups as believe approved significant

relief First lower the opioids. use function treatments patient, potential pain of and and return half on NeoCard offer foremost of for has rehabilitation the to and meaningful potentially with to time less clinically and roughly microfracture other

training. For simple does with administered superiority in that physicians, of established mechanism that action XX-minute relatively and require only can the we special product the one-year procedure not be endpoint a are

set from include data. well data short And that long-term trials. if outcomes We to at a non-clinical for and durability launch clinical of for patients. we We the of of through long-term five of our data Phase have time all I clinical the our expect are longer robust patients II Phase as already III approved, and two-year a subset from will as years Phase and clinical trial other have developing data both

For we of patients believe work with the quickly the potential and of debridement get the less more potential back has rehab with NeoCart microfracture overall lower total payers, care lower that costly to activity first may use. where the surgery starting and opioid for to NeoCart cost

also of within first be effectively the if prevent have We believe able that treat microfracture. two patients after able receiving first procedure to a cartilage currently the defect time, the we are to may costly second years we XX%-plus a that

small such delay source knee progression treating there total which product total as to brings these prevent by the a defects the the NeoCart, further at potential down replacement, with cost osteoarthritis care. of and eventual Finally, is or

a are recognize clinical these year We this results both to strategies, long-term topline present commercialization are trial of successful and robust and achieving in on data success excited we successful built critical that products areas both potential are top half approved. of and committed data we a every of NeoCart to in team. if XXXX second launch priority resources team, for strategy and Histogenics the driven member We talented the the a believe have execute later

We'll the now line. please NeoCart standard for we for Operator, the open questions. cartilage Thank open become for any up new defects. line painful small up with joining the call. If clear. believe is can goal of patients care Our you today's approved,

Operator

Jennings of our [Operator first Thank Instructions] Josh from Cowen. you. question And comes

is open. now Your line

Josh Jennings

the topline presentation to on in expect I gentlemen, on you and potentially to a at progress out out plan we map dataset also it and the see how and meeting? submission of and Good then could communicating congrats timing was XXXX. a just Hi. around full communicating morning, some you start if when data, hoping specifics street, the medical could

Adam Gridley

joining to Happy Sure. for do Josh. call the so. Thanks

results this License So our the of primary the subsequently investors quarter that Biologics to positive. endpoint quarter third of filing then everything third we data press our end by would would relevant and the via the the points assuming We topline XXXX, in is release report plans XXXX. Application summer other are file including the

course, that of by around would have that our peer-reviewed into We immediately noted time also data we and investors publication. move at point, start that a to

approval. Our expectation one evidence fully is, is We level agency. publish as comes top data clinical with be of out expectation to time audited that ones and probably would work package and My the gone peer-reviewed that in the investigators then that review that topline then or knowing journal. to has time potentially as our some launch times in XXXX around a advisors

Josh Jennings

Great. just just superiority Thanks they on plans showing that. microfracture? passed, assuming was enthusiasm share of to the commentary some about for you within being principal III just can your with positive Phase And that you anecdotal any investigators, recently with stable talk AAOS data adopt NeoCart of

Adam Gridley

scientific of And Academy feedback week where formal continued we continue that NeoCart New discussions an meeting, the a excellent safety combination And had positive as that very treatment. course anecdotal Surgeons provided. we on of the also in of function. the have potentially I ORS aspects we the subsequent presentations a our as return confirmed of that to hear at hear Orleans Society, and meeting, leading Absolutely, number then well of the of positive meetings to with were Research think Orthopedic American earlier Orthopedic recovery we series investigators last

think to get and doing to as with surgeons talk our those are commercialization start trying who NeoCart. microfracture surgeons strategies to starting are thinking lesion small about We take about really we procedures them about

from very to do three, this be board we've and they're from of thing other great first from be surgeons that do knees investigators, what seeing of true be I excited they attractive. the hearing then two, procedure and time why the the one they're And think can the patients. are understand it used across lesion trying four-square They're I of think continuing think the And is the may to for where I the each treatment that. results to the heard they're of pretty best their good course anecdotally treatment those saying to is centimeter alternatives to feedback.

And had implantation been pretty tissue. so folks mechanism and some of the action developing the feels the that about we've we a of acts native and Cornell at biomechanical time of creating at like with tissue discussion cartilage that ex-vivo describing of robust data

that I we population. to something the So helpful good communicate when feedback be the that really think other surgeons surgeons will this providing microfracture were in to that launch

heard lot was I a think thing the other international of that interest. we

for naturally we were So matter think come huge number both surgeons had heard they really treat NeoCart where at by patients are that international Japanese the have that I microfracture. booth, gap asking anything folks just recent and coming the across board, to still there when may heard and some and don't But a was doesn't the is There which surgeons of you're deal. markets what satisfaction region a in. about

take of we we the NeoCart United a So by folks be outside the more to wondering when from I'm lot able States. broadly interest coming may booth. have of

Josh Jennings

as Okay, there a capital, could MEDINET taking I of could we partnership possibly similar Thanks other establish the or just opportunities that hear regions that partnership mention are in to you questions. but that. to follow-up as another territories, in Europe? in well on another mean about some When Asia bring for

Adam Gridley

Asia and other sort we this for And as start negotiations take of do regions. with indicated more leading about days broadly early been start has to discussions Officer Business of want some and thanks question? you the Chief of interest course our the a of there that was Sure, we Josh. Haut, Don, question initial as lot Japan our Don in thinking from I'll

Donald Haut

Sure.

markets, really these a in of markets markets. campaign the the are are evaluating for understanding areas. those before are and patients reimbursement to looking market getting I game those it's environments a right terms surgical early of interesting there the looking dynamics an currently what that as ways interesting but partners information similar of again we and very of days plan as used about where patients treatment satisfaction is plan as early, parts understanding looking there size We're Our to well that better Japan, treated to the at first very regulatory in some, in gap seen two getting markets patients what look and market similar in are outside of taking and understanding market that Japan of of is were the - say two kinds There how middle similar plan then we've we're those the some getting now in said in into the well. what in but in we would game we've encouraging potential of

Operator

of from our comes next BTIG. you. Zimmerman Ryan And question Thank

now line open. is Your

Ryan Zimmerman

question. taking thanks the Great, for

of BLA year half that of of of part in as it's that activities think you loaded the SG&A start a terms and in we and think appreciate providing about little you cost the we back higher just color to XXXX And later expenses, I year? Thank guys the then those terms should the submit if commercial increase just expected in of we're the - also So could more cadence than you guidance in expense operating for little for? higher you. looking expenses, a get more

Jonathan Lieber

question. Thanks Ryan for the

year. the less it's of weighted I think say is one way of come towards the probably think guidance, and basically of of So a more end then two, a about quarter, the heavily it, rest than would and the I back quarters it total XX% will each little in we

your your guess and So start with with. to I would tend to comment agree

So first I QX and heavily the towards weighted then balance QX. XX% back half about more XX%, and in in is the it say, would the call couple quarters

Ryan Zimmerman

activities get Great. what of then XXXX, just some goals of Thank the can once far and submit of Okay. in terms a as for following little you're things you more BLA thinking have terms as And you you. provide about you commercial the submission? to the color BLA, in done your

Donald Haut

doing reimbursement access we're of in we the deep for our up building and area the and doing are part What fairly Sure. a - in prepare to organization. now is understand right market that dive that activity

concrete are working strategic our And to plan get once pull later more should topline idea or plenty of year we're service the we of - the on our to We the for as data. well building would our and in side working final organization of the our on the commercial aspects like. well plans as together that and have business infrastructure look what of planning

Ryan Zimmerman

XX%, Don. for hop similar your And about Appreciate a that said that then cartilage. referenced and correct you - lastly appreciate queue. NeoCart just Adam, comments, me was if I me, I'll back study in you I'm wrong, to native

you're would points be expand citing have bit what from anymore data that and there could Thank you. little on So helpful? just you a just that study if that you

Adam Gridley

has Kennedy, Cornell happy Chief overview do it Sure. to with I'm who quick Operating to start I'll and our with strategic then been a the hand collaboration Steve University. managing so. And Officer,

data. the the of is that yes, source So

of of number couple at presentations a then agents and posters, ORS just over weeks, have of based and years the request last these the subsequent on We ago. publications, a where couple

a other kicked couple really a cell of ago the we've we're probably And so All to of and to a characterize things want of or of years we these of implanted biomechanical initial - leading into measuring articular how since the NeoCart hyaline in having points. [indiscernible] that and we just measures cartilage also some into and FDA of number developed the of that elements trying are certain reported of the before measure companies the Cornell, off patient with even patient. roughly to the many of world components cartilage. organizations the action biomechanical are the repair that results are of in tissue. some mechanism they case the demonstrated our either other tissue? going the of after one native therapies, them demonstrate have the of data collaboration a tissues evaluating the And you to that properties number on they prior they're further of cartilage XX% the go then And comment Steve, to

Stephen Kennedy

Ryan, have or can behave and fictional, under what Yes. of forces properties cartilage share and the to measure Adam. the three a under and the you course what or are properties? imagine generally like Sure, were important. So it NeoCart the - compressive it to the How then compressive of those kind surface forces, will knee and are of surface or are it measures that the share a are how three force, different behaves what how looks does force. piece frictional in properties very respond the we

will what measuring what where those at And scaffolding is so also look we that finished course the we've of and of achieve how native certainly that we the our in compare have during themselves been is like referring the and of look NeoCart, he end doing don't properties course, about cartilage is XX% when just manufacturing those is we happens particular, state we and talked properties. which product Adam to state to. the But initial

develops those that - the the actually it for are our and So product. a actually cartilage demonstrate FDA's as able we've understanding demonstrate using - is we Matrix been those NeoCart how be own develops properties produced. to The that Extracellular to able of to to capability the

Donald Haut

physician we're going really this hit they're they And important and results. Ryan, why? of of how albeit appreciate action see and data. third think really such second is think we these terms that's our support also provide recovering data they mechanism was agency. see regulatory rehab time of some and And is and anecdotally and And to great some for pretty to why the their patients feeling tend impressive ask the when strong to see impressive here they what to They is that seeing clinical with in I what and additional certainly first Japanese time to then overall. the discussions result central expect It start I

visibility this to data is surgeons regulatory an a of providing on initially and So that NeoCart more that how did we operates. we're part is requirement finding lot what initial

Ryan Zimmerman

Thanks accomplishments Understood. the on questions for congrats here. the and all

Adam Gridley

Ryan. Thanks,

Operator

our of And comes Sean question Lee next H.C. Wainwright. you. Thank from

is line Your open. now

Sean Lee

Jon. still first are the right of you planned study and done a My patient provide which U.S. that needs And enrollment the that taking enroll to Japanese you Adam the Could now? question. be for or to little you plan patients? results study. do the admitting color like, can on topline before following you step morning, more my What Good on Thank steps is study? starting prior on

Adam Gridley

with for that counterparts our Sean. of planning a had And meetings Sure. Thanks question MEDINET. we've Japanese and great sessions the number

We as are stage in that indicated. we planning

then taking the expectation In and here, in that half is materials to surgeon, initiate then developed we second process of that going the we enrollment would identifying now, documents, we're patient some Our translation going the communicate we're determining of right how Japanese that of to XXXX. training surgeons. to

the to latter year. very the next preparation quarter, we much part and expect get will of out we be so about planning the So as would then and

that will We clinical to actually patients then in start trial. see

we As trial the a for from here protocol study that confirmatory would implants of one And U.S. course in trial. NeoCart manufacture our of the support XX-patient is Boston NeoCart completing of to purposes two facilities versus the microfracture? randomization of same reminder, the as

Sean Lee

PMDA done the front? to protocol are sign on or off the has Just you still regulatory on all

Adam Gridley

part time were formal There but all actually standard be meetings notification, been or the All of place of of the have agreed our is trial provided course provided, of XXXX. will some to. additional that in protocol [indiscernible] negotiated spring of protocol a that clinical and took of elements major and as last major details the activities

this trial. So clinical through formal initiation this of standard the move that part of process to administrative is

Sean Lee

launch to that if the you doses with faster? it that. to ramp the number first to of manufacturing to second manufacturing can needed, you help My in that is to on preparations possible third second know is what's additional in XXXX. I party guys ramp And this potentially for the transfer up commercial up question to year? and but dosing hear planning the house, Great are manufacture

Jonathan Lieber

So This Jon. Sean, is it's a good question thanks.

million kind other would of our a talked begin still warning here, some about it order launch XXX equipment commercial of receipt actually of put new we at in here equates to and we facility in of first after where but a intent course clear. getting look evaluating Waltham, you been material we $XX And start positive we we sort once think sort it for about point takes total as have our going is of - to years the into. be XX We about so the $XX to expansion finish would to assume now the we about it and not would to inspection planned get and generating at capacity improvements be And of generating at of new of put plan set positive we of plan, going be actually ready some of making to million we get pre-approval that then of XX upon here as capacity sort next revenue that. hopefully building is terms to months out to to capacity that and of the capacity We're or to which It's validated that facility have potential BLA doing in what data capital and place. of that So upon intent. will lot the $XXX that - Waltham, put just launch to of to summer think Massachusetts, for units. facility of revenue process million exit be We're then in do, speak our units have to then expansion. from a full-year data when our our that production that and capacity and facility about with our we're we we - making intend the and bunch will clinical this we've a how XXXX

Sean Lee

Thank that's for and I the additional all have. you color

Adam Gridley

Sean. Thanks

Operator

Brandon Genuity. next from our question Canaccord And you. Thank Vasquez comes of

now open. line Your is

Brandon Vasquez

all Can Thanks question. you the hear right? for everyone. me Hi, taking

Adam Gridley

Hi, can. We Brandon.

Brandon Vasquez

Thanks. Great.

of competition, the for understand increased the guess to there help terms approach to going U.S., noise solution just in of is a market can and a Just is you've from I'm when you in obviously are you little lot dynamics an hit you novel running opportunity hearing can ground speak I awareness had some there you really to trying in increased what it you like launch the that guys to competitors this market, guys benefit a be the bit and something in XXXX? just

Adam Gridley

awareness increasing. a Sure. We've last the awareness you're They've pleased that here launch the competition in I The on. created Brandon. is And over at had our market kudos year. substantial think fantastic and from has question, opinion been them spot really Great see team Histogenics. the to to

to year space. launched seen results program better ago, think going I therapies they're starting robust provide I a and generation excitement really well cartilage both last pay are general Until They've there's week. starting first that some that of they about in attention than great or reported surgical that as and quarter patients, products. coverage, hopefully this procedures some the of new first the investors to to Macy reimbursement some think beat surgeons, very are a outcomes some to

team lesion activities. sort number is on I and large The an larger This extremely Macy of us a for other think overall. market. the that focused positive competitors of is this is

of awareness a job cartilage educating, tremendous done for and product. creating training, the previous that just and Some cell surgeons they've

in a And these to these and come out of procedures that are there's our the XX know a And smaller our each pay are United about you focus those our As they hope XX to products new will attention is as that of benefit every those which population there and microfracture day, does month. is starting surgeon those lesion of watching XXX,XXX year States. some of that case well. in really on

hopefully be small what something a patients. really is to we're is excited that product, and bring lesion and we good targeting microfracture and pleased can differentiated So those following

Brandon Vasquez

Thanks Great. great the on a XXXX. taking question and for congrats

Adam Gridley

you. Thank

Operator

for Thank you. Adam remarks. time. turn over at further questions to I this [Operator Instructions] And would back I'm Gridley the showing conference closing to no like any

Adam Gridley

operator. Thank participated thanks everyone you, today's And in call. who to

forward data, and forward launch BLA hopefully and Have We potentially our our sharing to I us, year have exciting as ramp and move transformative we ahead with our an NeoCart. with efforts everyone. progress of and and topline the report great day III you, Phase filing look a for commercialization up

Operator

the Ladies and for today's This conference. you does gentlemen, in program. participating thank conclude

may great You disconnect. have Everyone day. all a

Ocugen (OCGN) 15 Mar 182017 Q4 Earnings call transcript